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https://ntp.niehs.nih.gov/go/impact

Public Health Impact

The public impact of NTP's work can be measured through its use by other agencies, often to support the establishment of regulations or guidelines to protect human health. For example, OEHHA is the California agency responsible for the Safe Drinking Water and Toxic Enforcement Act of 1986; OEHHA has used NTP data in compiling their list of substances known to the state to cause cancer under Proposition 65.

The table below shows NTP citations in regulatory settings such as draft guidelines, final guidelines, rules, and regulations. To learn more and see the NTP information cited, click a title in the table. The table can be filtered by year or agency to view historical and/or agency-specific outcomes.

How to see more details and search with filtering and sorting

Click on the title to expand details to see a summary of the notice and the NTP information cited. If there is an arrow after the last CASRN, click on the arrow to see more CASRNs associated with the notice.

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Year Agency Title CASRN
2023 EPA
Control of Air Pollution from New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards

The EPA finalizing a program to further reduce air pollution, including ozone and particulate matter (PM), from heavy-duty engines and vehicles across the United States. The requirements in the final rule will lower emissions of NOX and other air pollutants (PM, hydrocarbons (HC), carbon monoxide (CO), and air toxics) beginning no later than model year 2027. This final rule is effective on March 27, 2023.

NTP Information Cited
National Toxicology Program (NTP). 2019. NTP Monograph on the Systematic review of traffic-related air pollution and hypertensive disorders of pregnancy. Research Triangle Park, NC: National Toxicology Program. NTP Monograph 07. https://doi.org/10.22427/NTP-MGRAPH-7

  • Type: Final Rule
  • January 24, 2023
  • 88 FR 2845
2023 EPA
Availability of New Approach Methodologies in the Endocrine Disruptor Screening Program; Notice of Availability and Opportunity for Comment

US EPA published a white paper announcing their intention to accept NAMs as alternatives to four existing Tier 1 assays for the endocrine disruptor screening program, including the rodent uterotrophic assay. These NAMs cover in vitro based estrogen receptor (ER) and androgen receptor (AR) pathway models that were conceptualized (AR) and/or validated (ER and AR) by NICEATM. The EPA also identified NAMs acceptable for priority setting and WoE analysis including QSAR models developed by NICEATM for ER and AR activity that are available in the OPERA tool (https://github.com/NIEHS/OPERA).

NTP Information Cited
Open (Quantitative) Structure-activity/property Relationship App (OPERA). In Silico Qualitative Structure Activity Relationship Consensus Models for ER and AR. https://ntp.niehs.nih.gov/go/opera

ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods). (2003). ICCVAM evaluation of in vitro test methods for detecting potential endocrine disruptors: Estrogen receptor and androgen receptor binding and transcriptional activation assays. (NIH Publication No. 03-4503). RTP, NC. https://ntp.niehs.nih.gov/iccvam/docs/endo_docs/edfinalrpt0503/edfinrpt.pdf

ICCVAM (Interagency Coordinating Committee on the Validation of Alternative Methods). (2018). A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States. http://dx.doi.org/10.22427/NTP-ICCVAM-ROADMAP2018

  • Type: Notice
  • January 19, 2023
  • 88 FR 3406
2023 OSHA
World Trade Center (WTC) Health Program; Addition of Uterine Cancer to the List of WTC-Related Health Conditions

In accordance with the World Trade Center (WTC) Health Program’s regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List of WTC-Related Health Conditions. This rule is effective on January 18, 2023.

NTP Information Cited
NTP (National Toxicology Program). 2021. Report on Carcinogens, Fifteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.  https://ntp.niehs.nih.gov/go/roc15

  • Type: Final Rule
  • January 18, 2023
  • 88 FR 2845
2022 OEHHA
Haloacetic Acids in Drinking Water - Adoption of Public Health Goals for Five Haloacetic Acids

On December 30, 2022, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has adopted and published Public Health Goals (PHGs) for the five regulated haloacetic acids (HAAs) found in drinking water as a result of disinfection methods: monochloroacetic acid (MCA), dichloroacetic acid (DCA), trichloroacetic acid (TCA), monobromoacetic acid (MBA), and dibromoacetic acid (DBA). A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The California Safe Drinking Water Act of 1996 requires OEHHA to develop PHGs based exclusively on public health considerations. PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water standards (Maximum Contaminant Levels, or MCLs) for California. The technical support document presents the scientific information available on the toxicity of the HAAs and the calculation of the PHGs. The PHGs of 0.2 parts per billion (ppb) for DCA, 0.1 ppb for TCA, and 0.03 ppb for DBA are based on carcinogenicity and are set at a level of risk of one additional cancer case per one million persons exposed over a lifetime. The PHGs of 53 ppb for MCA and 25 ppb for MBA are based on noncancer health effects. OEHHA also presents health-protective drinking water concentrations for noncancer health effects for DCA, TCA, and DBA. The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has adopted and published Public Health Goals (PHGs) for the five regulated haloacetic acids (HAAs) found in drinking water as a result of disinfection methods: monochloroacetic acid (MCA), dichloroacetic acid (DCA), trichloroacetic acid (TCA), monobromoacetic acid (MBA), and dibromoacetic acid (DBA).

NTP Information Cited
NTP (1991). Executive Summary of Safety and Toxicity Information. Dichloroacetic Acid (CASRN 79-43-6); Trichloroacetic Acid (CASRN 76-03-9). National Toxicology Program (NTP), National Institute of Health, Research Triangle Park, NC. Accessed at: http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/dcaa_508.pdf

National Toxicology Program (NTP). 1992. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Monochloroacetic Acid (CASRN 79-11-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 396. https://ntp.niehs.nih.gov/go/tr396abs

National Toxicology Program (NTP). 2007a. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CASRN 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 537. https://ntp.niehs.nih.gov/go/tr537abs

National Toxicology Program (NTP). 2007b. NTP Report on the Toxicology Studies of Dichloroacetic Acid (CASRN 79-43-6) in Genetically Modified (FVB Tg.AC Hemizygous) Mice (Dermal and Drinking Water Studies) and Carcinogenicity Studies of Dichloroacetic Acid (CASRN 79-43-6) in Genetically Modified [B6.129-Trp53tm1Brd (N5) Haploinsufficient] Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Genetically Modified Model Report 11. https://ntp.niehs.nih.gov/go/gmm11abs

National Toxicology Program (NTP). 2009. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CASRN 5589- 96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 549. https://ntp.niehs.nih.gov/go/tr549abs

National Toxicology Program (NTP). 2018. Report on Carcinogens Monograph on Haloacetic Acids found as Water Disinfection By-products. Research Triangle Park, NC: National Toxicology Program. RoC Monograph 12. https://doi.org/10.22427/ROC-MGRAPH-12

National Toxicology Program (NTP). 1996. Information Profile for NIEHS Nominations of Chemicals to the National Toxicology Program - Dibromoacetic Acid. Research Triangle Park, NC, National Toxicology Program, US Department of Health and Human Services. https://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/dibromoaceticacid_508.pdf

National Toxicology Program (NTP). 1999. Toxicology Data Management System. Historical Control Tumor Incidence Summary. Oral Water Studies. National Toxicology Program, US Department of Health and Human Services. https://ntp.niehs.nih.gov/go/historical_controls

National Toxicology Program (NTP). (2009). NTP Historical Controls Report. National Toxicology Program, US Department of Health and Human Services. https://ntp.niehs.nih.gov/go/historical_controls

NTP (National Toxicology Program). 2021. Report on Carcinogens, Fifteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://doi.org/10.22427/NTP-OTHER-1003

  • Type: Final Notice
  • December 30, 2022
  • Public Health Goals
79-43-6
76-03-9
79-11-8
631-64-1
5589-96-8 79-08-3
631-64-1
2022 OEHHA
Notice of Adoption Title 27, California Code of Regulations Article 5, New Section 25506 Exposures to Acrylamide in Cooked or Heat Processed Foods

On December 20, 2022, the Office of Administrative Law approved the Office of Environmental Health Hazard Assessment’s proposal to amend Title 27, California Code of Regulations by adopting Section 25506, originally proposed as Section 25505. The new section addresses acrylamide in food formed by cooking or heat processing. The regulation will be effective on April 1, 2023.

NTP Information Cited
National Toxicology Program (NTP). 2012. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Acrylamide (CASRN 79-06-1) in F344/N Rats and B6C3F1 Mice (Feed and Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 575. https://ntp.niehs.nih.gov/go/tr575abs

National Toxicology Program (NTP). 2014. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Glycidamide (CASRN 5694-00-8) in F344/N Nctr Rats and B6C3F1/Nctr Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 588. https://doi.org/10.22427/NTP-TR-588

  • Type: Regulatory Information
  • December 23, 2022
  • Proposition 65
79-06-1
5694-00-8
2022 OEHHA
Decline to List Proposition 65 - 2022 Carcinogen Identification Committee

At the December 14 meeting of the Carcinogen Identification Committee (CIC), the CIC declined to list Bisphenol A as a carcinogen under Proposition 65 by a vote of 5 (yes) to 6 (no). The CIC voted 10 — 0, with one abstention, to affirm the update to the Section 27000 list recommended in the staff report.

NTP Information Cited
National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of Bisphenol A (CASRN 80-05-7) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 215. https://ntp.niehs.nih.gov/go/tr215abs

National Toxicology Program (NTP). 1995. Genetic Toxicity Evaluation of Bisphenol A (CASRN 80-05-7) in Micronucleus Study A24930 in F344 Rats. Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP).  https://cebs.niehs.nih.gov/cebs/study/002-01728-0005-0000-5

National Toxicology Program (NTP). 1999a. Historical B6C3F1 Mice 1984-1994 19 Studies Oral Feed Route. https://ntp.niehs.nih.gov/ntp/historical_controls/nih-07_1999/m_hcrpt_rte19991223.rpt

National Toxicology Program (NTP). 1999b. Historical F344 Rats 1984-1994 19 Studies Oral Feed Route.  https://ntp.niehs.nih.gov/ntp/historical_controls/nih-07_1999/r_hcrpt_rte19991223.rpt

National Toxicology Program (NTP). 2008. Toxicology and Carcinogenesis Study of Genistein (CASRN 446-72-0) in Sprague Dawley Rats (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 545. https://ntp.niehs.nih.gov/go/tr545abs

National Toxicology Program (NTP). 2010. Toxicology and Carcinogenesis Study of Ethinyl Estradiol (CASRN 57-63-6) in Sprague-Dawley Rats (Feed Study).  Research Triangle Park, NC: National Toxicology Program. Technical Report 548. https://ntp.niehs.nih.gov/go/tr548abs

National Toxicology Program (NTP). 2015. Handbook for Preparing Report on Carcinogens Monographs. Office of the Report on Carcinogens, National Institute of Environmental Health Sciences. https://ntp.niehs.nih.gov/ntp/roc/handbook/roc_handbook_508.pdf

National Toxicology Program (NTP). 2016. Standard Search Strings for Literature Database Searches: Appendix to the Draft Handbook for Preparing Report on Carcinogens Monographs: April 1, 2016. Office of the Report on Carcinogens, National Institute of Environmental Health Sciences. https://ntp.niehs.nih.gov/ntp/roc/handbook/rochandbookappendix_508.pdf

National Toxicology Program (NTP). 2018. NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats. NTP RR 9. Research Triangle Park, NC. National Toxicology Program (9): 1-221. https://doi.org/10.22427/NTP-RR-9

National Toxicology Program (NTP). 2021. NTP research report on the consortium linking academic and regulatory insights on bisphenol A toxicity (CLARITY-BPA): a compendium of published findings. Research Triangle Park, NC: National Toxicology Program. Research Report 18. https://doi.org/10.22427/NTP-RR-18

National Toxicology Program (NTP). 2021b. NTP Historical Controls Report All Routes and Vehicles Harlan Sprague-Dawley Rats December 2020.  https://ntp.niehs.nih.gov/ntp/historical_controls/ntp2000_2020/r_hcrpt_allrte20201200.pdf

  • Type: Final Notice
  • December 15, 2022
  • Proposition 65
80-05-7
2022 OEHHA
1-Bromopropane Cancer Inhalation Unit Risk Factor (IUR) Document - Scientific Notice of Adoption of Cancer Inhalation Unit Risk and Slope Factors for 1-Bromopropane

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new cancer inhalation unit risk (IUR) and slope factors for 1-Bromopropane (1-BP) for use in the Air Toxics Hot Spots Program. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In implementing this requirement, OEHHA develops new IURs and revises existing IURs for many air pollutants. The IUR for 1-BP was developed using the most recent guidance, “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors,” finalized by OEHHA in 2009. The values for 1-BP are as follows: Inhalation Unit Risk Factor 3.7 x 10e-6 (µg/m10e+3)10e-1 Inhalation Slope Factor 1.3 × 10e-2 (mg/kg-day)10e-1 A draft document for the 1-BP IUR was released on May 12, 2021, to solicit public comment and was discussed at a virtual public workshop during the subsequent 45-day public review period. No public comments were received on the document. The document was peer reviewed by the State’s Scientific Review Panel (SRP) on Toxic Air Contaminants in October 2021 before being finalized.

NTP Information Cited
National Toxicology Program (NTP). 2013. Report on Carcinogens. Monograph on 1-Bromopropane. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/roc/thirteenth/monographs_final/1bromopropane_508.pdf

National Toxicology Program (NTP). 2012. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CASRN 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 564. https://ntp.niehs.nih.gov/go/tr564 

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Reproductive and Developmental Effects of 1-Bromopropane. NIH Publication 04-4479. National Toxicology Program-Center for the Evaluation of Risks to Human Reproduction. Online at: https://ntp.niehs.nih.gov/ntp/ohat/bromopropanes/1-bromopropane/1bp_monograph.pdf 

National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Tribromomethane (Bromoform) (CASRN 75-25-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 350. https://ntp.niehs.nih.gov/go/tr350 

National Toxicology Program (NTP). 1987. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Bromodichloromethane (CASRN 75-27-4) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 321. https://ntp.niehs.nih.gov/go/tr321 

National Toxicology Program (NTP). 1982b. Carcinogenesis Bioassay of 1,2-Dibromo-3-Chloropropane (CASRN 96-12-8) in F344 Rats and B6C3F1 Mice (Inhalation Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 206. https://ntp.niehs.nih.gov/go/tr206

National Toxicology Program (NTP). 1982a. Carcinogenesis Bioassay of 1,2-Dibromoethane (CASRN 106-93-4) in F344 Rats and B6C3F1 Mice (Inhalation Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 210. https://ntp.niehs.nih.gov/go/tr210 

NTP-CEBS (2011a). NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CASRN 106-94-5) in F344/N Rats and B6C3F1 Mice(Inhalation Studies). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program. Accessed December 2022. https://cebs.niehs.nih.gov/cebs/publication/TR-564

NTP-CEBS (2011b). NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CASRN 106-94-5) in F344/N Rats and B6C3F1 Mice(Inhalation Studies). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program. Accessed December 2022. https://cebs.niehs.nih.gov/cebs/publication/TR-564

  • Type: Final Rule
  • December 09, 2022
  • Air Toxics Hot Spots Program
106-94-5
75-25-2
75-27-4
96-12-8
106-93-4 106-94-5
2022 EPA
Drinking Water Contaminant Candidate List 5-Final

The U.S. Environmental Protection Agency (EPA) is issuing the Contaminant Candidate List (CCL) which is a list of contaminants in drinking water that are currently not subject to any proposed or promulgated national primary drinking water regulations. In addition, these contaminants are known or anticipated to occur in public water systems and may require regulation under the Safe Drinking Water Act (SDWA). This list is the Fifth Contaminant Candidate List (CCL 5) published by the agency since the SDWA amendments of 1996. CCL 5 includes 66 chemicals, 3 chemical groups (cyanotoxins, disinfection byproducts (DBPs), and per- and polyfluoroalkyl substances (PFAS)), and 12 microbial contaminants.

NTP Information Cited
National Toxicology Program (NTP). Testing Status of Vanadyl Sulfate 08004. Available: https://ntp.niehs.nih.gov/go/ts-08004 [accessed December 9, 2022]

National Toxicology Program (NTP). Testing Status of Sodium Metavanadate M940043. Available: https://ntp.niehs.nih.gov/go/ts-m940043 [accessed December 9, 2022]

  • Type: Notice of Availability
  • November 14, 2022
  • 87 FR 68060
27774-13-6
13718-26-8
2022 OEHHA
Safe Harbor Warning Regulation for Exposures to Acrylamide from Food

The Office of Administrative Law approved the Office of Environmental Health Hazard Assessment’s proposal to amend Title 27, California Code of Regulations by adding new subsection 25607.2(b) to Section 25607.2. This new subsection addresses warning content for exposures to acrylamide in food by providing an additional non-mandatory, safe harbor warning option for businesses that cause significant exposures to acrylamide in foods. The regulation will be effective on January 1, 2023.

NTP Information Cited
National Toxicology Program (NTP). (2005). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Acrylamide. NIH Publication No. 05-4472. US Department of Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, MD. https://ntp.niehs.nih.gov/ntp/ohat/acrylamide/acrylamide_monograph.pdf

National Toxicology Program (NTP). 2012. Toxicology and Carcinogenesis Studies of Acrylamide (CASRN 79-06-1) in F344/N Rats and B6C3F1 Mice (Feed and Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 575. https://ntp.niehs.nih.gov/go/tr575abs

National Toxicology Program (NTP). 2014. Toxicology and Carcinogenesis Studies of Glycidamide (CASRN 5694-00-8) in F344/N Nctr Rats and B6C3F1/Nctr Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 588. https://doi.org/10.22427/NTP-TR-588

National Toxicology Program (NTP). 2015. National Toxicology Program Handbook for Preparing Report on Carcinogens Monographs. US Department of Health and Human Services. https://ntp.niehs.nih.gov/whatwestudy/assessments/cancer/handbook/index.html

NTP (National Toxicology Program). 2021. Report on Carcinogens, Fifteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://doi.org/10.22427/NTP-OTHER-1003

NTP (National Toxicology Program). 2021. Acrylamide. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acrylamide.pdf

  • Type: Regulation Approval
  • November 01, 2022
  • Proposition 65
79-06-1
5694-00-8
2022 EPA
Proposed Finding that Lead Emissions from Aircraft Engines that Operate on Leaded Fuel Cause or Contribute to Air Pollution that May Reasonably be Anticipated to Endanger Public Health and Welfare

Administrator is proposing to find that lead air pollution may reasonably be anticipated to endanger the public health and welfare within the meaning of section 231(a) of the Clean Air Act.

NTP Information Cited
National Toxicology Program (NTP), 2012. Monograph on Health Effects of Low-level Lead. U.S. Department of Health and Human Services. June 2012. https://ntp.niehs.nih.gov/go/36443

  • Type: Proposed action
  • October 17, 2022
  • 87 FR 62753
7439-92-1
2022 OEHHA
Safe Harbor Warning Regulation for Exposures to Glyphosate from Consumer Products

On September 1, 2022, the Office of Administrative Law approved the Office of Environmental Health Hazard Assessment’s proposal to amend Title 27, California Code of Regulations by adopting Sections 25607.48 and 25607.49. These new sections provide safe harbor guidance for businesses that cause exposures to glyphosate from consumer products that require a warning under Proposition 65. The regulations will be effective on January 1, 2023.

NTP Information Cited
National Toxicology Program (NTP): “reasonably anticipated to be a human carcinogen”, NTP, 2021. Report on Carcinogens, Fifteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc15

  • Type: Final Rule
  • September 08, 2022
  • Proposition 65
1071-83-6
2022 EPA
Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances

Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (``CERCLA'' or ``Superfund''), the Environmental Protection Agency (EPA or the Agency) is proposing to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances.

NTP Information Cited

National Toxicology Program (NTP). 2022. NTP Technical Report on the Toxicity studies of Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (revised). Research Triangle Park, NC: National Toxicology Program. Toxicity Report 97. https://doi.org/10.22427/NTP-TOX-97

National Toxicology Program (NTP). 2022. NTP Technical Report on the Toxicity Studies of Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (revised). Research Triangle Park, NC: National Toxicology Program. Toxicity Report 96. https://doi.org/10.22427/NTP-TOX-96

  • Type: Proposed Rule
  • September 06, 2022
  • 87 FR 54415
335-76-2
307-24-4
375-95-1
335-67-1
375-73-5 3871-99-6
1763-23-1
50892-23-4
2022 OEHHA
Chromium, Trivalent (Inorganic Water-Soluble Compounds)

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for Chromium, Trivalent (Inorganic Water-Soluble Compounds) (Cr(III)) for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to Cr(III) in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposure.

NTP Information Cited
National Toxicology Program (NTP). 1996a. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Nickel Oxide (CASRN 1313-99-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 451. https://ntp.niehs.nih.gov/go/tr451abs

National Toxicology Program (NTP). 1996b. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Nickel Sulfate Hexahydrate (CASRN 10101-97-0) in F344/N Rats and B6C3F1 Mice (Inhalation Studies) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 454. https://ntp.niehs.nih.gov/go/tr454abs

National Toxicology Program (NTP). 2008. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Chromium Picolinate Monohydrate (CASRN. 27882-76-4) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 556. https://ntp.niehs.nih.gov/go/tr556abs

  • Type: Notice
  • August 31, 2022
  • Air Toxics Hot Spots Program
1313-99-1
10101-97-0
27882-76-4
2022 OEHHA
Proposition 65: No Significant Risk Level for Antimony Trioxide

The Office of Environmental Health Hazard Assessment (OEHHA) is proposing to adopt a Proposition 65 No Significant Risk Level (NSRL) for antimony trioxide by amending Title 27, California Code of Regulations, section 25705(b). The proposed NSRL for antimony trioxide is 0.13 micrograms per day.

NTP Information Cited
National Toxicology Program (NTP). 2017 NTP Technical Report on the Toxicology and Carcinogenesis Studies of Antimony Trioxide (CASRN 1309-64-4) in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 590. https://doi.org/10.22427/NTP-TR-590

National Toxicology Program (NTP). 2018. Report on Carcinogens Monograph on Antimony Trioxide (CASRN 1309-64-4). Research Triangle Park, NC: National Toxicology Program. RoC Monograph 13. https://doi.org/10.22427/ROC-MGRAPH-13

  • Type: Proposed Rule
  • August 26, 2022
  • Proposition 65
1309-64-4
2022 EPA
Addition of Diisononyl Phthalate Category; Community Right-to-Know Toxic Chemical Release Reporting

On September 5, 2000, in response to a petition filed under the Emergency Planning and Community Right-to-Know Act (EPCRA), EPA issued a proposed rule to add a diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the Pollution Prevention Act (PPA). EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that this category met the EPCRA toxicity criterion. EPA has updated its hazard assessment for DINP and is proposing to add DINP as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. The updated hazard assessment demonstrates that the proposed DINP category meets the EPCRA toxicity criterion because the members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans; specifically, developmental, kidney, and liver toxicity. EPA is proposing to add the DINP category to the toxic chemical list on this basis and is requesting comment on the updated DINP hazard assessment and associated updated economic analysis.

NTP Information Cited
NTP (National Toxicology Program). 2016. Di(2-ethylhexyl) Phthalate. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/diethylhexylphthalate.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dinp/dinp_monograph_final.pdf

  • Type: Proposed rule
  • August 08, 2022
  • 87 FR 48128
117-81-7
68515-48-0
28553-12-0
2022 OEHHA
Adoption of Regulations: Warnings for Cannabis (Marijuana) Smoke and Delta-9-Tetrahydrocannabinol (Delta-9-THC) Exposure

On August 4, 2022, the Office of Administrative Law approved amendments to Title 27, California Code of Regulations by adopting Sections 25697.38 through 24607.47 into Title 27 of the California Code of Regulations. The new sections address exposures to listed cannabis (marijuana) smoke and Delta-9-THC.

NTP Information Cited
National Toxicology Program (NTP). 1996. NTP Technical Report on the Toxicology and Carcinogenesis Studies of of 1-Trans-delta9-tetrahydrocannabinol (CASRN 1972-08-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 446. https://ntp.niehs.nih.gov/go/tr446abs

  • Type: Final Approval
  • August 08, 2022
  • Proposition 65
1972-08-3
2022 OSHA
Advance Notice of Proposed Rule Making (ANPRM)—Blood Lead Level for Medical Removal

OSHA is considering rulemaking to revise its standards for occupational exposure to lead based on medical findings since the issuance of OSHA’s lead standards that adverse health effects in adults can occur at Blood Lead Levels (BLLs) lower than the medical removal level (≥60 mg/dL in general industry, ≥50 mg/dL in construction) and lower than the level required under current standards for an employee to return to their former job status (<40 mg/dL).1 The agency is seeking input on reducing the current BLL triggers in the medical surveillance and medical removal protection provisions of the general industry and construction standards for lead. The agency is also seeking input about how current ancillary provisions in the lead standards can be modified to reduce worker BLLs.

NTP Information Cited

National Toxicology Program (NTP). (2012). NTP Monograph: Health effects of low- level lead. Retrieved from: https:// ntp.niehs.nih.gov/ntp/ohat/lead/final/ monographhealtheffectslowlevellead_ newissn_508.pdf. Accessed on November 10, 2020.

  • Type: Proposed Rule
  • June 28, 2022
  • 87 FR 38343
7439-92-1
2022 OEHHA
Proposition 65: No Significant Risk Level for 1,3-Dichloropropene (1,3-D)

The Office of Environmental Health Hazard Assessment (OEHHA) has adopted an NSRL of 3.7 micrograms per day for exposures to 1,3-dichloropropene by the oral and inhalation routes.

NTP Information Cited

National Toxicology Program (NTP). 1985. Toxicology and Carcinogenesis Studies of Telone II (Technical-Grade 1,3-Dichloropropene (CASRN 542-75-6) Containing 1.0% Epichlorohydrin as a Stabilizer) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-269.
https://ntp.niehs.nih.gov/go/tr269abs

  • Type: Proposition
  • June 21, 2022
542-75-6
2022 CDC
World Trade Center (WTC) Health Program; Addition of Uterine Cancer to the List of WTC-Related Health Conditions

Title I of the James Zadroga 9/ 11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program (Program), which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within CDC, provides medical monitoring and treatment to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with the WTC Health Program’s regulations, which establish procedures for adding a new condition to the list of health conditions covered by the Program, this proposed rule would add malignant neoplasms of corpus uteri and uterus, part unspecified (uterine cancer) to the List of WTC-Related Health Conditions (List).

NTP Information Cited
NTP (National Toxicology Program). 2021. Report on Carcinogens, Fifteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.  https://doi.org/10.22427/NTP-OTHER-1003

  • Type: Proposed Rule
  • May 10, 2022
  • 87 FR 27961
2022 EPA
Asbestos; Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA)

The Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for asbestos under the Toxic Substances Control Act (TSCA). EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestoscontaining articles (including as an impurity) in the four years prior to the date of publication of the final rule to electronically report certain exposurerelated information. This action would result in a one-time reporting obligation. EPA emphasizes that this proposed requirement would include asbestos that is a component of a mixture. The information sought includes quantities of asbestos (including asbestos that is a component of a mixture) and asbestoscontaining articles that were manufactured (including imported) or processed, types of use, and employee data. Reported information would be used by EPA and other Federal agencies in considering potential future actions, including risk evaluation and risk management activities. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input.

NTP Information Cited
National Toxicology Program (NTP). 2022. Report on Carcinogens, Fifteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed Rule
  • May 06, 2022
  • 87 FR 27060
1332–21–4
132207–32–0
12001–28–4
2172–73–5
77536–67–5 77536–68–6
77536–66–4
2022 FDA
Action Levels for Lead in Juice; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Action Levels for Lead in Juice: Guidance for Industry." The draft guidance, when finalized, would establish action levels of 10 parts per billion (ppb) for lead in single-strength (ready-to-drink) apple juice and 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Notice
  • April 29, 2022
  • 87 FR 25491
7439-92-1
2022 EPA
Restoring Protective Human Health Criteria in Washington

The Environmental Protection Agency (EPA) has determined that Washington's human health criteria (HHC) are not protective of Washington's designated uses and are not based on sound scientific rationale and, accordingly, is proposing to restore protective HHC for Washington's waters. EPA partially approved and partially disapproved Washington's HHC in November 2016, and simultaneously promulgated federal HHC based on sound scientific rationale. In May 2019, EPA reversed its November 2016 disapproval and approved Washington's HHC, and in June 2020 withdrew the 2016 HHC that EPA promulgated for Washington. Based on the best scientific information and analyses currently available, and consideration of these past decisions, EPA has concluded that Washington's existing HHC are not based on sound scientific rationale and are therefore not protective of the applicable designated uses in Washington. EPA is therefore proposing to reinstate the protective and science-based federal HHC that EPA withdrew in June 2020 to protect Washington's waters, including waters where tribes hold treaty-reserved rights to fish.

NTP Information Cited
NTP (National Toxicology Program). 2021. Report on Carcinogens, Fifteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://doi.org/10.22427/NTP-OTHER-1003

  • Type: Proposed rule
  • April 01, 2022
  • 87 FR 19046
2022 EPA
Control of Air Pollution From New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards

The Environmental Protection Agency (EPA) is proposing a rule that would reduce air pollution from highway heavy-duty vehicles and engines, including ozone, particulate matter, and greenhouse gases. This proposal would change the heavy-duty emission control program-- including the standards, test procedures, useful life, warranty, and other requirements--to further reduce the air quality impacts of heavy- duty engines across a range of operating conditions and over a longer period of the operational life of heavy-duty engines.

NTP Information Cited
National Toxicology Program (2019) NTP Monograph on the Systematic Review of Traffic-related Air Pollution and Hypertensive Disorders of Pregnancy. NTP Monograph 7. https://ntp.niehs.nih.gov/ntp/ohat/trap/mgraph/trap_final_508.pdf

  • Type: Proposing Rule
  • March 28, 2022
  • 87 FR 17414
2022 OEHHA
Notification Level Recommendation for Perfluorohexane Sulfonic Acid (PFHxS) in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) is recommending that the State Water Resources Control Board (Water Board) establish the notification level (NL) for perfluorohexane sulfonic acid (PFHxS) at 2 parts per trillion, or the lowest level at which it can be reliably detected in drinking water using currently available and appropriate technologies. This recommendation is based on OEHHA’s development of a health-protective concentration intended to prevent noncancer effects, including thyroid, liver, and developmental toxicity.

NTP Information Cited
NTP (2019). NTP Technical Report on the Toxicity Studies of Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats. TOX-96. National Toxicology Program, https://cebs.niehs.nih.gov/cebs/publication/TOX-96.

  • Type: Recommendation
  • March 17, 2022
  • Water
375-73-5
3871-99-6
1763-23-1
50892-23-4
2022 CPSC
Notice of Availability: Final Guidance on Alternative Test Methods and Integrated Testing Approaches

The Consumer Product Safety Commission (Commission or CPSC) is announcing the availability of a document titled, "Final Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.'' The final guidance will be available at: https://www.regulations.gov under docket number, CPSC-2021-0006, under “Supporting and Related Material".

NTP Information Cited
ICCVAM - Validation and Regulatory Acceptance of Toxicological Test Methods. March 1997. https://ntp.niehs.nih.gov/iccvam/docs/about_docs/validate.pdf

ICCVAM - ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods. September 2003. https://ntp.niehs.nih.gov/iccvam/suppdocs/subguidelines/sd_subg034508.pdf

ICCVAM - Appendix D: ICCVAM Validation and Regulatory Acceptance Criteria. https://ntp.niehs.nih.gov/iccvam/suppdocs/subguidelines/sg034508/sgappd.pdf

ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods – September 2003. https://ntp.niehs.nih.gov/iccvam/suppdocs/subguidelines/sd_subg034508.pdf

  • Type: Notice
  • March 01, 2022
  • 87 FR 18772
2022 OEHHA
Notice to Interested Parties Chemical Listed Effective February 25, 2022 As Known to the State of California to Cause Cancer: Perfluorooctanoic Acid

Effective February 25, 2022, for purposes of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) is adding perfluorooctanoic acid (PFOA) (CASRN 335-67-1) to the list of chemicals known to the State of California to cause cancer. The listing of perfluorooctanoic acid (PFOA) is based on its formal identification by the National Toxicology Program (NTP), an authoritative body for purposes of Proposition 65, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306. The basis for the listing was described in a public notice published in the March 19, 2021, issue of the California Regulatory Notice Register (Register 2021, No. 12-Z). The title of the notice was “Notice of Intent to List Chemical by the Authoritative Bodies Mechanism: Perfluorooctanoic Acid.” The publication of the notice initiated a 45-day public comment period. OEHHA received five sets of comments during the comment period.

NTP Information Cited

National Toxicology Program (NTP 2011). Specifications for the conduct of studies to evaluate the toxic and carcinogenic potential of chemical, biological and physical agents in laboratory animals for the National Toxicology Program (NTP). January 2011. https://ntp.niehs.nih.gov/ntp/test_info/finalntp_toxcarspecsjan2011.pdf

National Toxicology Program (NTP 2019a). NTP Historical Controls Report, All Routes and Vehicles, Harlan Sprague-Dawley Rats. Version April 2019. US Department of Health and Human Services, NTP, Research Triangle Park, NC. Available from: https://ntp.niehs.nih.gov/ntp/historical_controls/ntp2000_2019/r_hcrpt_allrte20190400.pdf

National Toxicology Program (NTP 2019b). NTP Historical Controls Report, All Routes and Vehicles, Harlan Sprague-Dawley Rats. Version November 2019. US Department of Health and Human Services, NTP, Research Triangle Park, NC. Available from: https://ntp.niehs.nih.gov/ntp/historical_controls/ntp2000_2019/r_hcrpt_allrte20191100.pdf

National Toxicology Program (NTP 2020). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats. Technical Report Series No. 598. US Department of Health and Human Services, NTP, Research Triangle Park, NC.  https://doi.org/10.22427/NTP-TR-598

  • Type: Notice
  • February 25, 2022
  • Proposition 65
335-67-1
2021 EPA
Review of the National Primary Drinking Water Regulation: Lead and Copper Rule Revisions (LCRR)

On June 16, 2021, the U.S. Environmental Protection Agency (EPA) published the agency's decision to delay the effective and compliance dates of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR), published on January 15, 2021, to allow time for EPA to review the rule in accordance with Presidential directives issued on January 20, 2021, to the heads of Federal agencies to review certain regulations, and conduct important consultations with affected parties. EPA has completed its review. The agency's review included a series of virtual public engagements to hear directly from a diverse set of stakeholders. This document describes the comments conveyed by stakeholders, EPA's decision to proceed with a proposed rule that would revise certain key sections of the LCRR while allowing the rule to take effect, and other non-regulatory actions that EPA and other Federal agencies can take to reduce exposure to lead in drinking water.

NTP Information Cited

National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Regulatory Information
  • December 17, 2021
  • 86 FR 71574
7439-92-1
2021 OEHHA
Notice of Proposed Rulemaking Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: 1,3-Dichloropropene

The Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt Proposition 65 No Significant Risk Levels (NSRLs) for 1,3-dichloropropene by amending Title 27, California Code of Regulations, section 25705(b). The proposed NSRLs for oral and inhalation exposures to 1,3-dichloropropene are 3.7 micrograms per day.

NTP Information Cited

National Toxicology Program (NTP, 1985). Toxicology and carcinogenesis studies of Telone II (technical-grade 1,3-dichloropropene [CAS No. 542-75-6] containing 1.0% epichlorohydrin as a stabilizer) in F344/N rats and B6C3F1 mice (gavage studies). TR No. 269. US Department of Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, MD. https://ntp.niehs.nih.gov/go/tr269abs

  • Type: Notice
  • October 22, 2021
  • Proposition 65
542-75-6
2021 EPA
Addition of Certain Chemicals; Community Right-to-Know Toxic Chemical Release Reporting

In response to a petition filed under the Emergency Planning and Community Right-to-Know Act (EPCRA), EPA is proposing to add 12 chemicals to the list of toxic chemicals subject to the reporting requirements under EPCRA and the Pollution Prevention Act (PPA). EPA believes that each of the 12 chemicals meets the EPCRA criteria. In addition, based on the available bioaccumulation and persistence data, EPA believes that one chemical should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical and designated as a chemical of special concern with a 100-pound reporting threshold.

NTP Information Cited

NTP. 2005. 1,3-Dichloro-2-propanol [CAS No. 96–23–1]. Review of toxicological literature. Prepared by Integrated Laboratory Systems, Inc., Research Triangle Park, North Carolina, for the National Toxicology Program, National Institute of Environmental Health Sciences.  https://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/dichloropropanol_508.pdf

NTP. 1992. Final report on the reproductive toxicity of formamide (FORM) (CAS no. 75–12–7) in CD–1 Swiss mice: Volume 1 NTIS Technical Report 109213(327). https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB93109213.xhtml

NTP. 1992. Final report on the reproductive toxicity of formamide (FORM) (CAS no. 75–12–7) CD–1 (trade name) Swiss mice: Volume 2. Laboratory supplement. NTIS Technical Report 109221(249).  https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB93109221.xhtml

NTP. 1998. Final report on the developmental toxicity of formamide (CAS No. 75–12–7) administered by gavage to Sprague-Dawley CD rats on gestational days 6–19. NTIS Technical Report 139701(106).  https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB99139701.xhtml

NTP. 2001. Developmental toxicity evaluation of formamide (CAS No. 75– 12–7) administered by gavage to New Zealand white rabbits on gestational days 6 through 29. NTIS Technical Report 104060(460) https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB2001104060.xhtml

NTP. 1991. NTP toxicology and carcinogenesis studies of tris(2- chloroethyl) phosphate (CAS No. 115– 96–8) in F344/N rats and B6C3F1 mice (gavage studies). National Toxicology Program Technical Report Series 391: 1– 233. https://ntp.niehs.nih.gov/go/tr391abs

NTP. 1991. Final report on the reproductive toxicity of tris(2- chloroethyl)phosphate reproduction and fertility assessment in Swiss CD–1 mice when administered via gavage. NTIS Technical Report 129170(253).   https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB92129170.xhtml

Morrissey, R. E., B.A. Schwetz, J.C. Lamb, M.D. Ross, J.L. Teague, and R.W. Morris. 1988. Evaluation of rodent sperm vaginal cytology and reproductive organ weight data from National Toxicology Program 13-week studies. Fundam. Appl. Toxicol. 11(2): 343–358.  https://doi.org/10.1016/0272-0590(88)90159-5

  • Type: Regulatory Information
  • October 18, 2021
  • 86 FR 57614
96-23-1
75-12-7
115-96-8
2021 FDA
Termination of Listing of Color Additives Exempt From Certification; Lead Acetate

The Food and Drug Administration (FDA or we) is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled "Termination of Listing of Color Additives Exempt From Certification; Lead Acetate," which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.

NTP Information Cited

National Toxicity Program, 2012. Monograph on Health Effects of Low-level Lead. U.S. Department of Health and Human Services. June 2012. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Regulatory Information
  • October 08, 2021
  • 86 FR 56183
7439-92-1
2021 OEHHA
Announcement of the Carcinogen Identification Committee Meeting Scheduled for December 6, 2021; Notice of Availability of Hazard Identification Materials for Perfluorooctane Sulfonic Acid (PFOS) and Its Salts and Transformation and Degradation Precursors

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) will convene a meeting of the Carcinogen Identification Committee (CIC) for possible listing of perfluorooctane sulfonic acid (PFOS) and its salts and transformation and degradation precursors under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)[1]. OEHHA is also opening a 45-day public comment period on the hazard identification document for these chemicals. The public comment period will end on Monday, November 8, 2021. A copy of the document is available on OEHHA’s web site at https://oehha.ca.gov/proposition-65. The document may also be requested from OEHHA’s Proposition 65 Implementation Office by calling (916) 445-6900.

NTP Information Cited
NTP. 2020. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (HSD:Sprague Dawley SD) Rats. Research Triangle Park, North Carolina. Available: https://doi.org/10.22427/NTP-TR-598

NTP. 2019. NTP Technical Report on the Toxicity Studies of Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd: Sprague Dawley SD) Rats. Research Triangle Park, North Carolina: National Toxicology Program. Available: https://ntp.niehs.nih.gov/go/tox096abs 

NTP. 2015. Handbook for Preparing Report on Carcinogens Monographs. National Toxicology Program. Available: https://ntp.niehs.nih.gov/go/rochandbook 

  • Type: Notice
  • September 24, 2021
  • Proposition 65
335-67-1
2021 OEHHA
Notice of Proposed Rulemaking New Subsection 25607.2(b) Warning Content for Acrylamide Exposure from Food

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to add a new subsection to Article 6 of Title 27 of the California Code of Regulations.[1] This rulemaking proposes to add the following new subsection to Section 25607.2: (b) A warning for food exposures to acrylamide meets the requirements of this subarticle if it is provided: (i) in accordance with subsection (a), or, (ii) via one or more of the methods specified in Section 25607.1 and includes both elements (1) and (2) below​. (1) The words “CALIFORNIA WARNING:” in all capital letters and bold print. (2) The words, "Consuming this product can expose you to acrylamide, a probable human carcinogen formed in some foods during cooking or processing at high temperatures. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed. For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide."

NTP Information Cited
NTP (2015). National Toxicology Program Handbook for Preparing Report on Carcinogens Monographs. US Department of Health and Human Services. Available from: https://ntp.niehs.nih.gov/go/rochandbook 

National Toxicology Program (NTP 2014). Toxicology and Carcinogenesis Studies of Glycidamide in F344/N Nctr Rats and B6C3F1/Nctr Mice (Drinking Water Studies). TR No. 588. US Department of Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, MD. Available from: https://doi.org/10.22427/NTP-TR-588

National Toxicology Program (NTP, 2012). Toxicology and Carcinogenesis Studies of Acrylamide in F344/N Rats and B6C3F1 Mice (Feed and Drinking Water Studies). TR No. 575. US Department of Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, MD. Available from: https://ntp.niehs.nih.gov/go/tr575 

NTP (2005). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Acrylamide. NIH Publication No. 05-4472. US Department of Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, MD. Available from: https://ntp.niehs.nih.gov/ntp/ohat/acrylamide/acrylamide_monograph.pdf 

  • Type: Notice
  • September 17, 2021
  • Proposed Rule
5694-00-8
79-06-1
2021 OEHHA
Amendment to Section 25705 No Significant Risk Level for Trichloroacetic Acid

On July 6, 2021, the Office of Administrative Law approved the amendment to Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical trichloroacetic acid. The regulation will be effective on October 1, 2021. This regulation establishes a No Significant Risk Level of 9.9 micrograms per day for trichloroacetic acid for purposes of Proposition 65

NTP Information Cited
National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No.71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-583

NTP (1999). National Toxicology Program Historical Controls. US Department of Health and Human Services. Available from: https://ntp.niehs.nih.gov/ntp/research/database_searches/historical_controls/path/m_orlwr.txt 

  • Type: Notice
  • September 14, 2021
  • Proposition 65
71133-14-7
2021 OEHHA
Amendment to Section 25705 No Significant Risk Level for Dichloroacetic Acid

On June 24, 2021, the Office of Administrative Law approved the amendment to Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical dichloroacetic acid. The regulation will be effective on October 1, 2021. This regulation establishes a No Significant Risk Level of 17 micrograms per day for dichloroacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No.71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-583

NTP (1999). National Toxicology Program Historical Controls. US Department of Health and Human Services. Available from: https://ntp.niehs.nih.gov/ntp/research/database_searches/historical_controls/path/m_orlwr.txt 

  • Type: Notice
  • September 14, 2021
  • Proposition 65
71133-14-7
2021 OEHHA
Amendment to Section 25705 No Significant Risk Level for Dibromoacetic Acid

On July 6, 2021, the Office of Administrative Law approved the amendment to Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical dibromoacetic acid. The regulation will be effective on October 1, 2021. This regulation establishes a No Significant Risk Level of 2.8 micrograms per day for dibromoacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP 2007). Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CAS No. 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 537. NIH Publication No. 07-4475. US Department of Health and Human Services, NTP, Research Triangle Park, NC. Available at: https://ntp.niehs.nih.gov/go/tr537 

NTP. Sodium nitrite (7632-00-0). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed 2021-05-10. https://cebs.niehs.nih.gov/cebs/publication/TR-495 

NTP. Sodium chlorate (7775-09-9). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed 2021-05-10. https://cebs.niehs.nih.gov/cebs/publication/TR-517 

  • Type: Notice
  • September 14, 2021
  • Proposition 65
631-64-1
7632-00-0
7775-09-9
2021 FDA
Listing of Color Additives Exempt From Certification; Butterfly Pea

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC (Sensient).

NTP Information Cited
NTP, Toxicology and Carcinogenesis Studies of Quercetin (CAS No. 117–39–5) in F344 Rats (Feed Studies). NTP Technical Report Series, No. 409, 1992. https://ntp.niehs.nih.gov/go/tr409 

  • Type: Final Rule
  • September 02, 2021
  • 86 FR 49230
117-39-5
2021 OEHHA
Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) in Drinking Water

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) announces the availability of a draft technical support document for proposed Public Health Goals (PHGs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water.

NTP Information Cited
National Toxicology Program (NTP). 2016. NTP monograph on immunotoxicity associated with exposure to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS). Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/go/PFAS

NTP (2019a). NTP Technical Report on the Toxicity Studies of Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd: Sprague Dawley SD) Rats. Research Triangle Park, North Carolina, National Toxicology Program. NTP Tox-97. https://doi.org/10.22427/NTP-TOX-97

NTP (2019b). NTP Technical Report on the Toxicity Studies of Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd: Sprague Dawley SD) Rats. Research Triangle Park, North Carolina, National Toxicology Program. https://doi.org/10.22427/NTP-TOX-96

NTP Tox-96. NTP (2019c). NTP Historical Controls Report: All Routes and Vehicles Harlan Sprague-Dawley Rats. Research Triangle Park, North Carolina, National Toxicology Program. https://doi.org/10.22427/NTP-TOX-96

National Toxicology Program (NTP). 2020. NTP technical report on the toxicology and carcinogenesis studies of perfluorooctanoic acid (CASRN 335-67-1) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats. Research Triangle Park, NC: National Toxicology Program. Technical Report 598. https://doi.org/10.22427/NTP-TR-598

  • Type: Notice
  • July 22, 2021
  • Public Health Goals
307-24-4
335-67-1
375-95-1
335-76-2
375-73-5 3871-99-6
1763-23-1
50892-23-4
2021 EPA
National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective and Compliance Dates

The effective date of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR) that was published in the Federal Register on January 15, 2021. EPA is also delaying the January 16, 2024 compliance date established in the LCRR to October 16, 2024. The delay in the effective date is consistent with presidential directives issued on January 20, 2021, to the heads of Federal agencies to review certain regulations, including the LCRR. The delay allows EPA sufficient time to complete its review of the rule in accordance with those directives and conduct important consultations with affected parties. Delay of the LCRR compliance date ensures that any delay in the effective date will not reduce the time provided for drinking water systems and primacy states to take actions needed for ensuring compliance with the LCRR.

NTP Information Cited
National Toxicity Program, 2012. Monograph on Health Effects of Low-level Lead. U.S. Department of Health and Human Services. June 2012. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Final Rule
  • June 16, 2021
  • 86 FR 31939
7439-92-1
2021 ATSDR
Toxicological Profile for Perfluoroalkyls

The ATSDR toxicological profile succinctly characterizes the toxicology and adverse health effects information for the toxic substance. Each peer-reviewed profile identifies and reviews the key literature that describes a substance's toxicological properties.

NTP Information Cited

National Toxicology Program (NTP). 2020. Technical Report on the Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd: Sprague Dawley SD) Rats. Research Triangle Park, NC: National Toxicology Program. TR-598.
https://ntp.niehs.nih.gov/go/tr598abs

  • Type: Notice
  • May 05, 2021
  • 74 FR 36492
335-67-1
2021 OEHHA
Report Links Synthetic Food Dyes to Hyperactivity and other Neurobehavioral Effects in Children

A state report released today finds that consumption of synthetic food dyes can result in hyperactivity and other neurobehavioral problems in some children, and that children vary in their sensitivity to synthetic food dyes. The report by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) also finds that current federal levels for safe intake of synthetic food dyes may not sufficiently protect children’s behavioral health. The levels were established by the US Food and Drug Administration decades ago and do not reflect newer research. The percentage of American children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) has increased from an estimated 6.1% to 10.2% during the last 20 years. Concerns about increasing rates of ADHD and other behavioral disorders prompted the California Legislature to ask OEHHA to conduct the food dye assessment. Evidence shows that synthetic food dyes are associated with adverse neurobehavioral outcomes in some children, said OEHHA Director Dr. Lauren Zeise. With increasing numbers of U.S. children diagnosed with behavioral disorders, this assessment can inform efforts to protect children from exposures that may exacerbate behavioral problems. The report is the product of a two-year, multifaceted evaluation of seven synthetic food dyes that have been approved by the FDA. OEHHA extensively reviewed existing studies of the effects of these dyes on both humans and laboratory animals.

NTP Information Cited
NTP Office of Health Assessment and Translation. 2019. OHAT Systematic Review. https://ntp.niehs.nih.gov/go/ohathandbook

Yang R. 1993. NTP technical report on the toxicity studies of a Chemical Mixture of 25 Groundwater Contaminants Administered in Drinking Water to F344/N Rats and B6C3F(1) Mice. Toxic Rep Ser 35:1-I12. Available: https://ntp.niehs.nih.gov/go/tox35abs

  • Type: Risk Assessment
  • April 16, 2021
2021 OEHHA
Notice of Intent to List Chemical by the Authoritative Bodies Mechanism: Perfluorooctanoic Acid

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list perfluorooctanoic acid (PFOA) (CAS RN 335-67-1) as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). This action is being proposed pursuant to the Authoritative Bodies listing mechanism. According to the National Toxicology Program (NTP 2020), PFOA was widely used in manufacturing of a variety of consumer products that included many nonstick applications, such as for clothing and cookware. PFOA is no longer produced in the US and its production and use worldwide was significantly curtailed with the 2019 ban of the compound under the Stockholm Convention on Persistent Organic Pollutants. However, its persistence in the environment and breakdown of certain other per- and polyfluoroalkyl substances result in continued PFOA exposure. NTP is one of several institutions designated as authoritative for the identification of chemicals as causing cancer [Section 25306(m) of the Title 27 of the Cal. Code of Regulations]. After an authoritative body has made a determination about a chemical, OEHHA evaluates whether listing under Proposition 65 is required using the criteria contained in the regulations.

NTP Information Cited
National Toxicology Program (NTP 2019a). NTP Historical Controls Report, All Routes and Vehicles, Harlan Sprague-Dawley Rats. Version April 2019. US Department of Health and Human Services, NTP, Research Triangle Park, NC. Available from: https://ntp.niehs.nih.gov/ntp/historical_controls/ntp2000_2019/r_hcrpt_allrte20190400.pdf

National Toxicology Program (NTP 2019b). NTP Historical Controls Report, All Routes and Vehicles, Harlan Sprague-Dawley Rats. Version November 2019. US Department of Health and Human Services, NTP, Research Triangle Park, NC. Available from: https://ntp.niehs.nih.gov/ntp/historical_controls/ntp2000_2019/r_hcrpt_allrte20191100.pdf

National Toxicology Program (NTP). 2020. NTP technical report on the toxicology and carcinogenesis studies of perfluorooctanoic acid (CASRN 335-67-1) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats. Research Triangle Park, NC: National Toxicology Program. Technical Report 598. https://doi.org/10.22427/NTP-TR-598

  • Type: Notice
  • March 19, 2021
  • Proposition 65
335-67-1
2021 EPA
National Primary Drinking Water Regulations: Lead and Copper Rule Revisions; Delay of Effective Date

The Environmental Protection Agency (EPA or Agency) is issuing a short delay of the March 16, 2021, effective date of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR), published in the Federal Register on January 15, 2021. The LCRR will now become effective on June 17, 2021. This final rule does not change the compliance date of January 16, 2024. This delay in the effective date is consistent with Presidential directives issued on January 20, 2021, to heads of Federal agencies to review certain regulations, including the LCRR. The sole purpose of this delay is to enable EPA to take public comment on a longer extension of the effective date for EPA to undertake its review of the rule in a deliberate and thorough manner consistent with the public health purposes of the Safe Drinking Water Act and the terms and objectives of recent Presidential directives and in consultation with affected stakeholders.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Final Rule
  • March 12, 2021
  • 86 FR 14003
7439-92-1
2021 EPA
Announcement of Final Regulatory Determinations for Contaminants on the Fourth Drinking Water Contaminant Candidate List

The U.S. Environmental Protection Agency (EPA or Agency) is announcing final regulatory determinations for eight of the 109 contaminants listed on the Fourth Contaminant Candidate List. Specifically, the Agency is making final determinations to regulate perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) and to not regulate 1,1-dichloroethane, acetochlor, methyl bromide (bromomethane), metolachlor, nitrobenzene, and RDX. The Safe Drinking Water Act (SDWA), as amended in 1996, requires EPA to make regulatory determinations every five years on at least five unregulated contaminants. A regulatory determination is a decision about whether or not to begin the process to propose and promulgate a national primary drinking water regulation for an unregulated contaminant.

NTP Information Cited
National Toxicology Program (NTP). 1983. Report on the subchronic toxicity via gavage of nitrobenzene (C60082) in Fischer 344 rats and B6C3F1 mice [unpublished]. National Toxicology Program, prepared by the EG&G Mason Research Institute, Worcester, MA, for the National Toxicology Program, National Institute of Environmental Health Services, Public Health Service, U.S. Department of Health and Human Services, Research Triangle Park, NC; MRI–NTP 08–83–19 (as cited in USEPA, 2009).

NTP. 1992. Toxicology and carcinogenesis studies of methyl bromide (CAS NO. 74–83–9) in B6C3F1 mice (inhalation studies). U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health. https://ntp.niehs.nih.gov/go/tr385 

NTP. 2020. Technical report on the toxicology and carcinogenesis studies of perfluorooctanoic acid (CASRN 335–67–1) administered in feed to Sprague Dawley (Hsd: Sprague Dawley SD) rats. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health. https://doi.org/10.22427/NTP-TR-598 

  • Type: Regulatory Information
  • March 03, 2021
  • 86 FR 12272
98-95-3
74–83–9
335–67–1
2021 EPA
National Primary Drinking Water Regulations: Lead and Copper Rule Revisions

The Environmental Protection Agency (EPA) is publishing final regulatory revisions to the National Primary Drinking Water Regulation (NPDWR) for lead and copper under the authority of the Safe Drinking Water Act (SDWA). These revised requirements provide greater and more effective protection of public health by reducing exposure to lead and copper in drinking water. The rule will better identify high levels of lead, improve the reliability of lead tap sampling results, strengthen corrosion control treatment requirements, expand consumer awareness and improve risk communication. This final rule requires, for the first time, community water systems to conduct lead-in-drinking-water testing and public education in schools and child care facilities. In addition, the rule will accelerate lead service line replacements by closing existing regulatory loopholes, propelling early action, and strengthening replacement requirements.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Final Rule
  • January 15, 2021
  • 86 FR 4198
7439-92-1
2021 EPA
Review of Dust-Lead Post Abatement Clearance Levels

Reducing childhood lead exposure is a priority for the Environmental Protection Agency (EPA). As part of EPA's efforts to reduce childhood lead exposure, and in coordination with the President's Task Force on Environmental Health Risks and Safety Risks to Children, EPA reevaluated the 2001 dust-lead clearance levels (DLCL). Clearance levels indicate the amount of lead in dust on a surface following the completion of an abatement activity. Surface dust is collected via dust wipe samples that are sent to a laboratory for analysis to determine whether clearance has been achieved. The post-abatement dust-lead levels are evaluated against, and must be below, the applicable clearance levels. The DLCL have not changed since they were issued in 2001. EPA is finalizing its proposal to lower the DLCL from 40 micrograms of per square foot (µg/ft\2\) to 10 µg/ft\2\ for floors, and from 250 µg/ft\2\ to 100 µg/ft\2\ for window sills.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Final rule
  • January 07, 2021
  • 86 FR 983
7439-92-1
2020 OEHHA
Notice to Interested Parties Developmental Toxicity Endpoint Reinstated for the Listing of Bisphenol A (BPA) as Known to the State of California to Cause Reproductive Toxicity

Effective December 18, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) is adding the developmental endpoint to the existing reproductive toxicity (female endpoint) listing of bisphenol A (BPA) (CAS RN. 80-05-7) on the Proposition 65 list of chemicals known to the State to cause cancer or reproductive toxicity. Bisphenol A was added to the Proposition 65 list as known to cause reproductive toxicity for the female reproductive toxicity endpoint, effective May 15, 2015. The listing now includes an additional endpoint, developmental toxicity. The chemical was delisted effective April 19, 2013, based on a trial court injunction prohibiting the listing of BPA for the developmental endpoint pending final resolution of the case - American Chemistry Council [ACC] v Office of Environmental Health Hazard Assessment, et al., Sacramento County case number 34-2013-00140720. That court eventually denied the ACC’s challenge to the listing and the ACC appealed. The Court of Appeal kept an injunction in place pending their resolution of the case. On October 19, 2020 the Third District Court of Appeal entered a judgment affirming the trial court decision and an order dissolving the injunction. The time to seek California Supreme Court review has passed, so the Court of Appeal decision is final. Therefore, OEHHA is reinstating the developmental toxicity endpoint for the listing of BPA as causing reproductive toxicity at this time, on the same basis as the original listing for that endpoint https://oehha.ca.gov/proposition-65/crnr/notice-intent-list-bisphenol.

NTP Information Cited
National Toxicology Program (NTP). 2008. Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf 

  • Type: Notice
  • December 18, 2020
  • Proposition 65
80-05-07
2020 OEHHA
Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: p-Chloro-α,α,α-Trifluorotoluene

On December 2, 2020, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, which adopted a Proposition 65 No Significant Risk Level (NSRL) of 23 micrograms per day for the chemical p-chloro-α,α,α-trifluorotoluene (PCBTF). The regulation will be effective on April 1, 2021.

NTP Information Cited
National Toxicology Program (NTP 2018). Toxicology and Carcinogenesis Studies of p-Chloro-α,α,α- trifluorotoluene in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies). NTP Technical Report Series No. 594. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-594 

NTP (2015). Handbook for Preparing Report on Carcinogens Monographs. July 20, 2015. Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, US Department of Health and Human Services. https://ntp.niehs.nih.gov/go/rochandbook

  • Type: Notice
  • December 15, 2020
  • Proposition 65
98-56-6
2020 OEHHA
BPA Listing as Reproductive Toxicant Under Prop 65 Upheld by Court

The California Court of Appeal, Third Appellate District (Sacramento), has upheld the listing of bisphenol A (BPA) as a reproductive toxicant under Proposition 65 (Prop 65). Prop 65 a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.

NTP Information Cited
National Toxicology Program (NTP). 2008. Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf 

  • Type: Court opinion
  • October 19, 2020
  • Proposition 65
80-05-7
2020 CDC
Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Blood Lead Surveillance System (BLSS)'' (OMB Control No. 0920-0931, Exp. Date 05/31/2021). The National Center for Environmental Health (NCEH) is leading a three-year extension information collection request (ICR) for two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH).

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Notice with Comment Period
  • October 13, 2020
  • 85 FR 64474
7439-92-1
2020 OEHHA
Notice of Adoption of Cancer Inhalation Unit Risk Factors for Cobalt and Cobalt Compounds

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new cancer inhalation unit risk (IUR) and slope factors for Cobalt and Cobalt Compounds for use in the Air Toxics Hot Spots Program. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In implementing this requirement, OEHHA develops new IURs and revises existing IURs for many air pollutants. The IURs for cobalt and insoluble and soluble cobalt compounds were developed using the most recent guidance, “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors,” finalized by OEHHA in 2009.

NTP Information Cited
NTP (1996). Toxicology and Carcinogenesis Studies of Nickel Subsulfide (CAS No. 12035-72-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 453. Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr453

NTP (1998a). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Cobalt Sulfate Heptahydrate (CAS No. 10026-24-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP TR 471. Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr471

NTP (1998b). TR-471: Cobalt sulfate heptahydrate (10026-24-1). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November 2017. https://cebs.niehs.nih.gov/cebs/publication/TR-471 

NTP (2014a). NTP Technical Report on the Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies). NTP TR 581. Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-581 

NTP (2014b). TR-581: Cobalt (7440-48-4). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). Accessed November, 2017. https://cebs.niehs.nih.gov/cebs/publication/TR-581.

NTP (2016). National Toxicology Program. Cobalt and Cobalt Compounds That Release Cobalt Ions In Vivo, CAS No. 7440-48-4 (Cobalt metal). Report on Carcinogens, Fourteenth Edition. 8 p. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/cobalt.pdf 

  • Type: Air Toxics Hot Spots Program
  • October 02, 2020
12035-72-2
10026-24-1
7440-48-4
2020 EPA
Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water

The Environmental Protection Agency (EPA) is finalizing changes to existing regulations to protect the public from lead in plumbing materials used in public water systems or residential or nonresidential facilities providing water for human consumption. The changes in this rule codify aspects of the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA).

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Final Rule
  • September 01, 2020
  • 85 FR 54235
7439-92-1
2020 OEHHA
Notice of Adoption of Reference Exposure Levels for Toluene

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for Toluene for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to toluene in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposures. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In response to this statutory requirement, OEHHA develops RELs for many air pollutants, including Toluene. The Toluene RELs were developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for the Derivation of Noncancer Reference Exposure Levels” (OEHHA, 2008). Toluene has been demonstrated to have neurotoxic effects. This chemical will also be added to the list of Toxic Air Contaminants that may disproportionately impact children, pursuant to Health and Safety Code Section 39669.5(b)(1).

NTP Information Cited
National Toxicology Program (NTP) (1990). Toxicology and carcinogenesis studies of toluene in F344/N rats and B6C3F1 mice (inhalation studies). https://ntp.niehs.nih.gov/go/tr371 

  • Type: Notice
  • August 20, 2020
  • Air Toxics Hot Spots Program
108-88-3
2020 OEHHA
Notice of Adoption of Cancer Inhalation Unit Risk Factor for p-Chloro-a,a,a-Trifluorotoluene

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting a new cancer inhalation unit risk (IUR) and slope factor for p-Chloro-a,a,a-Trifluorotoluene for use in the Air Toxics Hot Spots Program. IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In implementing this requirement, OEHHA develops new IURs and revises existing IURs for many air pollutants. The IUR for PCBTF was developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors,” finalized by OEHHA in 2009.

NTP Information Cited
NTP (1992). Toxicity studies of p-chloro-a,a,a-trifluorotoluene (CAS No. 98-56-6) administered in corn oil and a-cyclodextrin to F344/N rats and B6C3F1 mice in 14-day comparative gavage studies. Toxicity Report Series. Technical Report No. 14. National Toxicology Program, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tox014

NTP (2009). Chemical Information Profile for 1-Chloro-4-(trifluoromethyl)-benzene (CAS No. 98-56-6); Supporting Nomination for Toxicological Evaluation by the National Toxicology Program. National Toxicology Program, National Institute of Environmental Health Sciences, June 2009. https://ntp.niehs.nih.gov/ntp/noms/support_docs/pcbtf060409.pdf 

NTP (2018). NTP Technical Report: Toxicology and Carcinogenesis Studies of p-Chloro-a,a,a-trifluorotoluene (CAS No. 98-56-6) in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies), TR 594. Reserach Triangle Park, NC, June 2019. https://doi.org/10.22427/NTP-TR-594

  • Type: Notice
  • August 07, 2020
  • Air Toxics Hot Spots Program
98-56-6
2020 OEHHA
Announcement of Publication of Updated Public Health Goal and Technical Support Document for 1,2-Dibromo-3-Chloropropane in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of the updated Public Health Goal (PHG) for 1,2-dibromo-3-chloropropane (DBCP). A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The updated Public Health Goal of 0.003 parts per billion (ppb) is based on carcinogenicity and is set at a level of risk of one additional cancer case per one million persons exposed over a 70-year lifetime.

NTP Information Cited
NTP (1982). Carcinogenesis bioassay of 1,2-dibromo-3-chloropropane in F344 rats and B6C3F1 mice (inhalation study). National Toxicology Program Technical Report Series No. 206, National Toxicology Program, Bethesda, MD. https://ntp.niehs.nih.gov/go/tr206 

  • Type: Proposition 65
  • July 17, 2020
96-12-8
2020 EPA
Review of Dust-Lead Post-Abatement Clearance Levels

Reducing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, backed by the President's Task Force on Environmental Health Risks and Safety Risks to Children, EPA evaluated the current dust-lead clearance levels (DLCL). Clearance levels are currently defined as the maximum amount of lead permitted in dust on a surface following completion of an abatement activity. Surface dust is collected via dust wipe samples that are sent to a laboratory for analysis. The post-abatement dust- lead levels must be below the clearance levels. The DLCL have not changed since they were issued in 2001. EPA is now proposing to lower the DLCL from 40 micrograms of per square feet (µg/feet squared) and 250 µg/feet squared to 10 µg/feet squared and 100 µg/feet squared for floors and window sills, respectively.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Proposed Rule
  • June 24, 2020
  • 85 FR 37810
7439-92-1
2020 OEHHA
Notice of Proposed Rulemaking Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Trichloroacetic Acid

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 9.9 micrograms per day for trichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited
National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-583

  • Type: Proposition 65
  • May 22, 2020
76-03-9
71133-14-7
2020 OEHHA
Notice Of Proposed Rulemaking Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Dibromoacetic Acid

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 2.8 micrograms per day for dibromoacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited
National Toxicology Program (NTP 2007). Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CAS No. 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 537. NIH Publication No. 07-4475. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr537

  • Type: Proposition 65
  • May 22, 2020
631-64-1
2020 OEHHA
Notice of Proposed Rulemaking Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Dichloroacetic Acid

Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 17 micrograms per day for dichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited
National Toxicology Program (NTP 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-583 

  • Type: Proposition 65
  • May 22, 2020
71133-14-7
2020 EPA , DOT
The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks

The Environmental Protection Agency and the National Highway Traffic Safety Administration, on behalf of the Department of Transportation, are issuing final rules to amend and establish carbon dioxide and fuel economy standards. Specifically, EPA is amending carbon dioxide standards for model years 2021 and later, and NHTSA is amending fuel economy standards for model year 2021 and setting new fuel economy standards for model years 2022-2026. The standards set by this action apply to passenger cars and light trucks, and will continue our nation's progress toward energy independence and carbon dioxide reduction, while recognizing the realities of the marketplace and consumers' interest in purchasing vehicles that meet all of their diverse needs. These final rules represent the second part of the Administration's action related to the August 24, 2018 proposed Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule. These final rules follow the agencies' actions, taken September 19, 2019, to ensure One National Program for automobile fuel economy and carbon dioxide emissions standards, by finalizing regulatory text related to preemption under the Energy Policy and Conservation Act and withdrawing a waiver previously provided to California under the Clean Air Act.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14 

  • Type: Final rule
  • April 30, 2020
  • 85 FR 24174
75-07-0
71-43-2
106-99-0
50-00-0
91-20-3
2020 OEHHA
Issuance of Safe Use Determination for Exposures to Bisphenol A from Certain Polycarbonate Eyewear Products Manufactured, Distributed, or Sold by The Vision Council Member Companies

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986. OEHHA received a request for a Safe Use Determination (SUD) for exposures to bisphenol A (BPA) from certain polycarbonate eyewear products manufactured, distributed, or sold by The Vision Council (TVC) member companies. Based on OEHHA’s screening-level analysis of the information and data provided by TVC, the upper-end estimate of dermal exposure to BPA for users of certain polycarbonate eyewear products (prescription glasses and sunglasses, OTC reading glasses, non-prescription sunglasses, and safety glasses) manufactured, distributed, or sold by TVC member companies, with acetonitrile extractable concentrations of BPA as specified above, is 0.53 µg/day. This exposure estimate falls below the "Maximum Allowable Dose Level (MADL)” for BPA (dermal exposure from solid materials) of 3 µg per day. The MADL is defined as the level of exposure that corresponds to the “no observed effect level” divided by 1000. Thus, exposures to BPA from use of such eyewear products, under the conditions described in OEHHA’s assessment, would not require a Proposition 65 warning.

NTP Information Cited
CERHR (2008). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC, National Toxicology Program: 395. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf 

  • Type: Notice
  • April 09, 2020
  • Proposition 65
80-05-7
2020 OEHHA
Announcement of Publication of Public Health Goals and Technical Support Document for Trihalomethanes In Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of Public Health Goals (PHGs) for four trihalomethanes (THMs) found in drinking water as a result of disinfection methods: chloroform, bromodichloromethane (BDCM), dibromochloromethane (DBCM), and bromoform. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure.

NTP Information Cited
NTP (1985). Toxicology and carcinogenesis studies of chlorodibromomethane (CAS No. 124- 48-1) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 282, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr282 

NTP (1987). Toxicology and carcinogenesis studies of bromodichloromethane (CAS No. 75-27- 4) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 321, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. 182 pp. https://ntp.niehs.nih.gov/go/tr321 

NTP (1988). Chloroform reproduction and fertility assessment in CD-1 mice when administered by gavage. Report by Environmental Health Research and Testing, Inc., Lexington, Kentucky, to National Toxicology Program, NTP-89-018. NTIS PB89-148639. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/racb87045abs 

NTP (1989a). Toxicology and carcinogenesis studies of tribromomethane (bromoform) (CAS No. 75-25-2) in F344/N rats and B6C3F1 mice (gavage studies). NTP Technical Report Series No. 350, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr350

NTP (1989b). Bromoform: reproduction and fertility assessment in Swiss CD-1 mice when administered by gavage. Report no. NTP-89-068. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/racb87111abs 

NTP (1994). Comparative toxicology studies of corn oil, safflower oil, and tricaprylin (CAS Nos. 8001-30-7, 8001-23-8, and 538-23-8) in male F344/N rats as vehicles for gavage. NTP Technical Report Series No. 426, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr426

NTP (1996). Final report on the short term reproductive and developmental toxicity of chlorodibromomethane (CAS No. 124-48-1) administered in drinking water to Sprague-Dawley rats. Report by R.O.W. Sciences, Inc., Gaithersburg, MD. Pub No. NTIS/PB97-111728. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/rdgt94003abs 

NTP (1998). Final Report on the short-term reproductive and developmental toxicity of bromodichloromethane (CAS No. 75-27-4) administered in drinking water to Sprague-Dawley rats. Pub no. NTIS/PB99-111262. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/rdgt94017abs 

NTP (2006). Toxicology and carcinogenesis studies of bromodichloromethane (CAS No. 75-27- 4) in male F344/N rats and female B6C3F1 mice (Drinking Water Studies). National Toxicol Program Tech Rep Ser 532:1-248. https://ntp.niehs.nih.gov/go/tr532

NTP (2007). Toxicology studies of bromodichloromethane (CAS No. 75-27-4) in genetically modified (FVB Tg.AC Hemizygous) mice (dermal, drinking water, and gavage studies) and carcinogenicity studies of bromodichloromethane in genetically modified [B6.129-Trp53(tm1Brd) (N5) haploinsufficient] mice (drinking water and gavage studies). NTP Genet Modif Model Rep 5:1-227. https://ntp.niehs.nih.gov/go/gmm05

NTP (2016a). Chloroform. NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/chloroform.pdf 

NTP (2016b). Bromodichloromethane. NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bromodichloromethane.pdf 

  • Type: Notice
  • February 07, 2020
  • Public Health Goals
67-66-3
75-25-2
75-27-4
124-48-1
8001-30-7 8001-23-8
538-23-8
2020 OEHHA
Chemicals Listed Effective January 3, 2020 As Known to The State of California To Cause Reproductive Toxicity (Developmental Endpoint): Cannabis (Marijuana) Smoke and Δ9-Tetrahydrocannabinol (Δ9-THC)

Effective January 3, 2020, the Office of Environmental Health Hazard Assessment is adding cannabis (marijuana) smoke and Δ9-tetrahydrocannabinol (Δ9-THC) to the list of chemicals known to the state to cause reproductive toxicity (developmental endpoint) for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)

NTP Information Cited
NTP. 1996. Toxicology and carcinogenesis studies of 1-trans-delta(9)- tetrahydrocannabinol (CAS No. 1972-08-3) in F344 rats and B6C3F1 mice (gavage studies). Natl Toxicol Program Tech Rep Ser 446:1-317. https://ntp.niehs.nih.gov/go/tr446 

  • Type: Notice
  • January 23, 2020
  • Proposition 65
1972-08-3
2019 EPA
Addition of Certain Per- and Polyfluoroalkyl Substances; Community Right-to-Know Toxic Chemical Release Reporting

In this advance notice of proposed rulemaking (ANPRM), EPA is soliciting information from the public as EPA considers proposing a future rule on adding certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). In this ANPRM, EPA outlines what PFAS are, why the Agency is considering adding certain PFAS to EPCRA section 313, what listing actions are being considered, who may be required to report, the current understanding of hazard concerns for PFAS, EPA’s hazard assessments on PFAS, and other information available on these chemicals. In considering a chemical for addition to the EPCRA section 313 list, EPA bases its listing decision on the chemical’s hazard (i.e., toxicity), not the risk (i.e., toxicity plus potential exposures) related to that chemical. EPA is requesting comment on which, if any, PFAS should be evaluated for listing, how to list them, and what would be appropriate reporting thresholds given their persistence and bioaccumulation potential. Lastly, EPA asks for any additional data to inform the Agency’s evaluation and determination of which PFAS may meet the EPCRA section 313 listing criteria.

NTP Information Cited
NTP. Per- and Polyfluoroalkyl Substances (PFAS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://ntp.niehs.nih.gov/go/PFAS

  • Type: Advance notice of proposed rulemaking
  • December 04, 2019
  • 84 FR 66369
N/A
2019 EPA
Community Right-to-Know; Corrections to Toxics Release Inventory (TRI) Reporting Requirements

EPA is proposing corrections to existing regulatory language for the Toxics Release Inventory (TRI) Program. EPA is proposing corrections that will update identifiers, formulas, and names for certain TRI-listed chemicals and updates to the text that identifies which chemicals the 0.1 percent de minimis concentration applies to in order to remedy a cross-reference to a no-longer-accurate Occupational Safety and Health Administration (OSHA) regulatory citation. These proposed corrections maintain previous regulatory actions and do not alter existing reporting requirements or impact compliance burdens or costs.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14

  • Type:  Proposed Rule; request for public comment
  • November 29, 2019
  • 84 FR 65739
N/A
2019 EPA
National Primary Drinking Water Regulations: Proposed Lead and Copper Rule Revisions

The Environmental Protection Agency (EPA) proposes regulatory revisions to the National Primary Drinking Water Regulation (NPDWR) for lead and copper under the authority of the Safe Drinking Water Act (SDWA). This proposed rule provides more effective protection of public health by reducing exposure to lead and copper in drinking water. This proposed rule also strengthens procedures and requirements related to health protection and the implementation of the existing Lead and Copper Rule (LCR) in the following areas: Lead tap sampling; corrosion control treatment; lead service line replacement; consumer awareness; and public education. This proposal does not include revisions to the copper requirements of the existing LCR. In addition, this proposal includes new requirements for community water systems to conduct lead in drinking water testing and public education in schools and child care facilities.

NTP Information Cited

National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Proposed Rule Revisions
  • November 13, 2019
  • 84 FR 61684
N/A
2019 OEHHA
Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: P-Chloro-α,α,α-Trifluorotoluene (PCBTF)

On Oct. 18, 2019, the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 23 micrograms per day for p-chloro-α,α,α-trifluorotoluene (PCBTF), by amending Title 27, California Code of Regulations, section 25705(b). https://oehha.ca.gov/proposition-65/crnr/notice-proposed-rulemaking-title-27-california-code-regulations-amendment-13

NTP Information Cited
NTP Technical Report on the Toxicology and Carcinogenesis Studies of p-Chloro-α,α,α-Trifluorotoluene (CASRN 98-56-6) in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies). Research Triangle Park (NC): National Toxicology Program. Natl Toxicol Program Res Rep Ser. 2018 June;(TR-594): 1-199. https://ntp.niehs.nih.gov/go/tr594

  • Type: Proposed Rule
  • October 18, 2019
  • Proposition 65
98-56-6
2019 CDC
World Trade Center Health Program; Petition 023—Uterine Cancer, Including Endometrial Cancer; Finding of Insufficient Evidence

On April 23, 2019, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 023) to add "endometrial cancer'' to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add the major site uterine cancer, including its subtype, endometrial cancer, to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14

  • Type: Final Rule
  • September 24, 2019
  • 84 FR 49954
N/A
2019 OEHHA
Notification Level Recommendations for Perfluorooctanoic Acid and Perfluorooctane Sulfonate in Drinking Water

This document presents final notification level (NL) recommendations by the Office of Environmental Health Hazard Assessment (OEHHA) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in drinking water. This supersedes the underlying scientific analysis (OEHHA, 2018) that supported the interim NLs that were adopted in 2018.

NTP Information Cited

NTP (2016). NTP Monograph Immunotoxicity Associated with Exposure to Perfluorooctanoic Acid or Perfluorooctane Sulfonate. National Toxicology Program, Research Triangle Park, NC. https://ntp.niehs.nih.gov/ntp/ohat/pfoa_pfos/pfoa_pfosmonograph_508.pdf

NTP (2018a). Tox-96: Perfluorinated Compounds: Sulfonates - Pathology Tables, Survival and Growth Curves from NTP Short-Term Studies. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=3874 (last accessed March 20, 2019).

NTP (2018b). Tox-97: Perfluorinated Compounds: Carboxylates - Pathology Tables, Survival and Growth Curves from NTP Short-Term Studies. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=3875 (last accessed March 20, 2019).

NTP (2018c). TR-598: Technical Report Pathology Tables and Curves - PFOA. National Toxicology Program, Research Triangle Park, NC. https://tools.niehs.nih.gov/cebs3/views/?action=main.dataReview&bin_id=13658 (last accessed March 20, 2019).

  • Type: Notice
  • August 23, 2019
  • Public Health Goals
335-67-1
1763-23-1
2019 EPA
Review of the Dust-Lead Hazard Standards and the Definition of Lead-Based Paint

Addressing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, this final rule revises the DLHS from 40 [micro]g/ft\2\ and 250 [micro]g/ft\2\ to 10 [micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors and window sills, respectively. EPA is also finalizing its proposal to make no change to the definition of LBP because insufficient information exists to support such a change at this time.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Final Rule
  • July 09, 2019
  • 84 FR 32632
N/A
2019 ATSDR
Availability of Draft Toxicological Profiles

This notice announces the availability of Set 26 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 26 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 26 Toxicological Profiles are available online at https://www.atsdr.cdc.gov/toxprofiles/index.asp and https://www.regulations.gov/#!home, docket ATSDR–2014–0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

NTP Information Cited

National Toxicology Program (NTP). 1988a. Developmental toxicity evaluation of 1,1,1-trichloroethane (CASRN 71-55-6) administered to CD rats. Final report part 1. Research Triangle Park, NC: National Toxicology Program. PB88131321. https://ntp.niehs.nih.gov/go/t0151abs

National Toxicology Program (NTP). 1988b. Developmental toxicity evaluation of 1,1,1-trichloroethane (CASRN 71-55-6) administered to CD rats. Final report part 2. Research Triangle Park, NC: National Toxicology Program. PB88134101. https://ntp.niehs.nih.gov/go/t0151abs

NTP (National Toxicology Program). 1989a. 1,1,1-Trichloroethane. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/tetrachloroethylene.pdf

NTP (National Toxicology Program). 1989b. Fiscal year 1989 annual plan. NTP 89167. National Toxicology Program. U.S. Department of Health and Human Services, 102-104. https://ntp.niehs.nih.gov/go/annualreport

National Toxicology Program (NTP). 1996. NTP Technical Report on Renal Toxicity Studies of Selected Halogenated Ethanes Administered by Gavage to F344/N Rats. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 45. https://ntp.niehs.nih.gov/go/tox45abs

National Toxicology Program (NTP). 2000. NTP Technical Report on Toxicity Studies of 1,1,1-Trichloroethane (CASRN 71-55-6) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 41. https://ntp.niehs.nih.gov/go/tox41abs

National Toxicology Program (NTP). 1986. Toxicology and Carcinogenesis Studies of Tetrachloroethylene (Perchloroethylene) (CASRN 127-18-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 311. https://ntp.niehs.nih.gov/go/tr311abs

NTP (National Toxicology Program). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • June 01, 2019
  • 79 FR 74093
71-55-6
79-01-6
127-18-4
7783-06-4
463-58-1 56-38-2
2019 EPA
Restrictions on Discontinued Uses of Asbestos; Significant New Use Rule

Under the Toxic Substances Control Act (TSCA), EPA is promulgating a rule to ensure that any discontinued uses of asbestos cannot re-enter the marketplace without EPA review, closing a loophole in the regulatory regime for asbestos.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14 

NTP (National Toxicology Program). Asbestos. 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.  https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf

  • Type: Regulatory Information
  • April 25, 2019
  • 84 FR 17345
1332-21-4
2019 OEHHA
Current Proposition 65 No Significant Risk Levels (NSRLs) Maximum Allowable Dose Levels (MADLs)

Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65. In some instances, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements. Please visit the Attorney General's Proposition 65 web site at https://ag.ca.gov/prop65 (link is external) for further information about specific enforcement actions.

NTP Information Cited

National Cancer Institute (NCI, 1980). Bioassay of 4,4'-0xydianiline for Possible Carcinogenicity. Carcinogenesis Technical Report Series No. 205. NIH Publication No. 80-1761. US Department of Health and Human Services, NCI Carcinogenesis Testing Program, and National Toxicology Program. https://ntp.niehs.nih.gov/go/tr205

National Toxicology Program (NTP, 1982). Toxicology and Carcinogenesis Studies of D & C Red 9 in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 225. NIH Publication No. 82-1781. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr225
 
National Toxicology Program (NTP, 1983). Toxicology and Carcinogenesis Studies of 4,4'-Methylenedianiline Dihydrochloride in F344/N Rats and B6CJF1 Mice (Drinking Water Studies). NTP Technical Report Series No. 248. NTIS Publication No. PB 83238824. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr248
 
National Toxicology Program (NTP, 1985). Toxicology and Carcinogenesis Studies of Chlorodibromomerhane in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 282. NIH Publication No. 85-2538. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr282
 
National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies· of Chlo1intJled Paraffins (Cl2. 60% Chlorine) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 308. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr308

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of 3-Chloro-2-methy/propene in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 300. NIH Publication No. 86-2556. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr300 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of C.l. Basic Red 9 Monohydrochloride in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 196. NlH Publication No. 86-2541. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr196
 
National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Diglycidyl Resorcinol Ether in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 257. NIH Publication No. 87-2513. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr257
 
National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Dimethylvinyl Chloride (1-chloro-2-methyl-propene) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 316. NIH Publication No. 86­ 2572. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr316
 
National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Disperse Blue 1 (a commercial dye containing approximately 50% 1,4,5,8-tetra amino anthraquinone, 30% other compounds structurally related to 1,4,5,8-tetra amino anthraquinone and 20% water in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 299. NIH Publication No. 86-2555. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr299 

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of HC Blue 1 in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series; No. 271. NTIS Publication No. PB 86-114683. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr271
 
National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Toluene Diisocyanate in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 251. NTIS Publication No. 87115176. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr251
 
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Chlorendic Acid in F344 Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 304. N1H Publication No. 87-2560, US Department of Health and Human Services (DHEW), NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr304
 
National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Hexachloroethane in F344/N Rats (Gavage Studies). NTP Technical Report Series No. 361. NTIS Publication No. 89-2816. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr361

National Toxicology Program (NTP, 1991). Chemical Status ReportUS Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/msr

  • Type: Notice
  • March 25, 2019
  • Proposition 65
101-80-4
5160-02-1
13552-44-8
108171-26-2
563-47-3
87-29-6
101-90-6
513-37-1
2475-45-8
26471-62-5
115-28-6
67-72-1
2019 FDA
Sunscreen Drug Products for Over-the-Counter Human Use

The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).

NTP Information Cited
NTP Technical Report 518, ‘‘Toxicology and Carcinogenesis Studies of Triethanolamine in B6C3F1 Mice (Dermal Study),’’ May 2004, (available at https://ntp.niehs.nih.gov/ntp/htdocs/lt_ rpts/tr518.pdf), accessed March 27, 2018. https://ntp.niehs.nih.gov/go/tr518

Technical Report 449, ‘‘Toxicology and Carcinogenesis Studies of Triethanolamine in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ November 1999, (available at https:// ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/ tr449.pdf), accessed March 27, 2018. https://ntp.niehs.nih.gov/go/tr449

French, J.E., ‘‘NTP Technical Report on the Toxicity Studies of 2-Hydroxy-4- Methoxybenzophenone (Cas No. 131–57–7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice,’’ Toxicity Report https://ntp.niehs.nih.gov/go/tox21abs

‘Testing Status of 2-Hydroxy-4- methoxybenzophenone 10260–S’’ (available at https://ntp.niehs.nih.gov/go/ts-10260-s), accessed March 27, 2018.

  • Type: Proposed Rule
  • February 26, 2019
  • 84 FR 6204
131–57–7
2019 OEHHA
Amendment to Section 25705 No Significant Risk Level for Bromodichloroacetic Acid

On February 5, 2019, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical bromodichloroacetic acid. The regulation will be effective on April 1, 2019. This regulation establishes a No Significant Risk Level of 0.95 micrograms per day for bromodichloroacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. https://ntp.niehs.nih.gov/go/tr583

  • Type: Notice
  • February 13, 2019
  • Proposition 65
71133-14-7
2019 OEHHA
Amendment to Section 25705 No Significant Risk Level for Bromochloroacetic Acid

On February 5, 2019, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, to add a No Significant Risk Level for the chemical bromochloroacetic acid. The regulation will be effective on April 1, 2019. This regulation establishes a No Significant Risk Level of 0.70 micrograms per day for bromochloroacetic acid for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 549. NIH Publication No. 09-5890. https://ntp.niehs.nih.gov/go/tr549

  • Type: Notice
  • February 13, 2019
  • Proposition 65
5589-96-8
2018 EPA
Chlorate; Pesticide Exemptions From Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of chlorate in or on cantaloupe and tomato under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited
National Toxicology Program (NTP). 2005. NTP technical report on the toxicology and carcinogenesis studies of sodium chlorate (CASRN 7775-09-9) in F344/N rats and B6C3F1 mice (Drinking water studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 517. https://ntp.niehs.nih.gov/go/tr517abs.

  • Type: Regulatory Information
  • December 26, 2018
  • 83 FR 66138
N/A
2018 OEHHA
Notice of Intent to List p-Chloro-α,α,α-trifluorotoluene (Para-Chlorobenzotrifluoride, PCBTF)

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list p-chloro-α,α,α-trifluorotoluene (also known as para-chlorobenzotrifluoride, or PCBTF) as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986[1]. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
National Toxicology Program (NTP, 2018). Toxicology and Carcinogenesis Studies of p-Chloro-α,α,α-Trifluorotoluene in Sprague Dawley Rats (Hsd:Sprague Dawley SD) and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 594. US Department of Health and Human Services, NTP, Research Triangle Park, NC.  Available at https://ntp.niehs.nih.gov/go/tr594abs.

  • Type: Intent to List
  • November 23, 2018
  • Proposition 65
98-56-6
2018 FDA
FDA Removes 7 Synthetic Flavoring Substances from Food Additives List

The Food and Drug Administration (FDA, the Agency, or we) is partially granting a petition submitted by the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids’ Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff, by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We are taking this action because, despite FDA’s scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners’ request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.

NTP Information Cited
NTP. Ethyl acrylate (140-88-5). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/140-88-5.

NTP. Benzophenone (119-61-9). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/119-61-9.

NTP. Methyleugenol (93-15-2). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/93-15-2.

NTP. beta-Myrcene (123-35-3). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/123-35-3.

NTP. Pulegone (89-82-7). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/89-82-7.

NTP. Pyridine (110-86-1). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs/test_article/110-86-1.

  • Type: Final Rule
  • October 05, 2018
  • 21 CFR Parts 172 and 177
119–61–9
140–88–5
93–15–2
123–35–3
89–82–7 110–86–1
100–42–5
2018 EPA
The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks

The National Highway Traffic Safety Administration (NHTSA) and the Environmental Protection Agency (EPA) are proposing the “Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks” (SAFE Vehicles Rule). The SAFE Vehicles Rule, if finalized, would amend certain existing Corporate Average Fuel Economy (CAFE) and tailpipe carbon dioxide emissions standards for passenger cars and light trucks and establish new standards, all covering model years 2021 through 2026. More specifically, NHTSA is proposing new CAFE standards for model years 2022 through 2026 and amending its 2021 model year CAFE standards because they are no longer maximum feasible standards, and EPA is proposing to amend its carbon dioxide emissions standards for model years 2021 through 2025 because they are no longer appropriate and reasonable in addition to establishing new standards for model year 2026. The preferred alternative is to retain the model year 2020 standards (specifically, the footprint target curves for passenger cars and light trucks) for both programs through model year 2026, but comment is sought on a range of alternatives discussed throughout this document. Compared to maintaining the post-2020 standards set forth in 2012, current estimates indicate that the proposed SAFE Vehicles Rule would save over 500 billion dollars in societal costs and reduce highway fatalities by 12,700 lives (over the lifetimes of vehicles through MY 2029). U.S. fuel consumption would increase by about half a million barrels per day (2-3 percent of total daily consumption, according to the Energy Information Administration) and would impact the global climate by 3/1000th of one degree Celsius by 2100, also when compared to the standards set forth in 2012.

NTP Information Cited
NTP. (2014). 13th Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. https://ntp.niehs.nih.gov/go/roc13.

  • Type: Notice of Proposed Rulemaking
  • August 24, 2018
  • 83 FR 42986
106-99-0
2018 OEHHA
Notice of Adoption of Cancer Inhalation Unit Risk and Slope Factors and Cancer Oral Slope Factor for Tert-Butyl Acetate

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting a new cancer inhalation unit risk factor (IUR) for tert-butyl acetate (TBAc). IURs are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen.

NTP Information Cited
National Toxicology Program (NTP). 1995. NTP Technical Report on the Toxicology and Carcinogenesis Studies of t -Butyl Alcohol (CASRN 75-65-0) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 436. https://ntp.niehs.nih.gov/go/tr436abs

  • Type: Notice
  • August 16, 2018
  • Air Toxics Hot Spots Program
75-65-0
2018 OEHHA
Announcement of Publication of Public Health Goals and Availability of Technical Support Document for Cis- and Trans-1,2-Dichloroethylene in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of updated Public Health Goals (PHGs) for cis- and trans-1,2-dichloroethylene (cis-/trans-1,2-DCE) in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The California Safe Drinking Water Act of 1996 requires OEHHA to develop PHGs based exclusively on public health considerations. PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water standards (Maximum Contaminant Levels, or MCLs) for California. The technical support document, available for download below, presents an update of the cis- and trans-1,2-DCE PHGs. The updated PHGs are 13 parts per billion (ppb) for cis-1,2-DCE based on kidney effects and 50 ppb for trans-1,2-DCE based on immune system effects.

NTP Information Cited
National Toxicology Program (NTP). 2002. NTP Technical Report on the Toxicity Studies of trans-1,2-Dichloroethylene (CASRN 156-60-5) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 55. https://ntp.niehs.nih.gov/go/tox55abs

  • Type: Notice
  • July 20, 2018
  • Public Health Goals
156-60-5
2018 EPA
Review of the Dust-Lead Hazard Standards and the Definition of Lead-Based Paint

Addressing childhood lead exposure is a priority for EPA. As part of EPA's efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, EPA is proposing to lower the DLHS from 40 μg/ft2 and 250 μg/ft2 to 10 μg/ft2 and 100 μg/ft2 on floors and window sills, respectively. EPA is proposing no changes to the current definition of LBP due to insufficient information to support such a change.

NTP Information Cited
HHS, National Toxicology Program. NTP Monograph: Health Effects of Low-Level Lead. 2012. https://ntp.niehs.nih.gov/go/36443.

  • Type: Proposed Rule
  • July 02, 2018
  • 83 FR 30889
N/A
2018 OEHHA
Authoritative Bodies Tracking Table

Status of chemicals considered by OEHHA for addition to the Proposition 65 list under the authoritative bodies mechanism.

NTP Information Cited
NTP Technical Report on the Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies) NTP (2014). https://ntp.niehs.nih.gov/go/tr581abs.

NTP Technical Report on the Toxicology and Carcinogenesis Studies of Trim VX in Wistar HAN [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies) NTP (2016). https://ntp.niehs.nih.gov/go/tr591abs.

  • Type: Notice
  • June 13, 2018
  • Proposition 65
7440-48-4
TRIMVX
50-32-8
2018 EPA
Asbestos; Significant New Use Rule

Under the Toxic Substances Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for asbestos as defined under the Asbestos Hazard Emergency Response Act. The proposed significant new use of asbestos (including as part of an article) in manufacturing (including importing) or processing for certain uses identified by EPA as no longer ongoing. The Agency has found no information indicating that the following uses are ongoing, and therefore, the following uses are subject to this proposed SNUR: Adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement).

NTP Information Cited
National Toxicology Program. (NTP, 2016). Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14.

  • Type: Proposed Rule
  • June 11, 2018
  • 40 CFR Part 721
1332-21-4
2018 OEHHA
Chemical Listed Effective May 25, 2018 as Known to the State of California to Cause Cancer: TRIM® VX

Effective May 25, 2018, the Office of Environmental Health Hazard Assessment (OEHHA) is adding TRIM® VX to the list of chemicals known to the State of California to cause cancer for purposes of Proposition 65. The listing of TRIM® VX is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306. The documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for TRIM® VX is included in the “Notice of Intent to List: TRIM® VX” posted on OEHHA’s website and published in the January 26, 2018 issue of the California Regulatory Notice Register (Register 2018, No. 4-Z). The publication of the notice initiated a public comment period that closed on February 26, 2018. OEHHA received two public comments on TRIM® VX. The comments and OEHHA’s responses are posted with the Notice of Intent to List.

NTP Information Cited
National Toxicology Program (NTP, 2016). NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM® VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 591. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr591abs.

  • Type: Notice
  • May 25, 2018
  • Proposition 65
TRIMVX
2018 OEHHA
Acrylamide

Acrylamide is on the Proposition 65 list of chemicals known to the state to cause cancer or reproductive toxicity (such as birth defects and other reproductive harm). Acrylamide is formed in some baked, fried and roasted foods. It is also present in tobacco smoke. Smokers are exposed to particularly high levels of acrylamide. Acrylamide is a carcinogen. It was added to the Proposition 65 list in 1990 because studies showed it produced cancer in laboratory rats and mice. In February 2011, acrylamide was added to the Proposition 65 list as causing reproductive and developmental effects because, in studies of laboratory animals, acrylamide affected the growth of offspring exposed in the womb and caused genetic damage that resulted in the death of mouse and rat embryos. Plant-based foods that are rich in carbohydrates can form acrylamide when baked, fried or roasted – whether they are cooked at home, in restaurants or by commercial food processors and manufacturers. French fries, potato chips, other fried and baked snack foods, coffee, roasted grain-based coffee substitutes, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, prune juice, breakfast cereals, crackers, cookies, breads, and toast all may contain varying amounts of acrylamide. Foods that have been boiled or steamed do not contain acrylamide. The U.S. Food and Drug Administration (FDA) and other health and scientific organizations continue to study the health effects of acrylamide in food. The FDA has not advised people at this time to stop eating products that contain acrylamide. The FDA does advise people to quit smoking.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14.

National Toxicology Program. (NTP, 2018). Acrylamide.https://www.niehs.nih.gov/health/topics/agents/acrylamide/index.cfm.

National Toxicology Program. (NTP, 2013). Fact sheet on Acrylamide. https://www.niehs.nih.gov/health/assets/docs_a_e/acrylamide_508.pdf.

  • Type: Notice
  • May 21, 2018
  • Proposition 65
79-06-1
2018 OEHHA
Notice of Amendment to Section 25705 no Significant Risk Level for Vinylidene Chloride

On May 9, 2018, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical vinylidene chloride. The regulation will be effective on July 1, 2018. This regulation establishes a No Significant Risk Level of 0.88 micrograms per day for vinylidene chloride for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology and Carcinogenesis Studies of Vinylidene chloride (CAS No. 75-35-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 582. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr582abs.

  • Type: Notice
  • May 17, 2018
  • Proposition 65
75-35-4
2018 OEHHA
Announcement of Publication of Public Health Goals and Availability of Technical Support Document for Nitrate and Nitrite in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of updated Public Health Goals (PHGs) for nitrate and nitrite in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The California Safe Drinking Water Act of 1996 requires OEHHA to develop PHGs based exclusively on public health considerations. PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water standards (Maximum Contaminant Levels, or MCLs) for California. The technical support document, presents an update of the nitrate and nitrite PHGs. A review of the scientific literature published since the development of the original nitrate and nitrite PHGs in 1997 has identified no new information to support changing the current PHGs of 45 parts per million (ppm) for nitrate and 3 ppm for nitrite. Nitrate and nitrite can also be expressed in terms of their concentrations as nitrogen. When expressed as nitrogen, 45 ppm nitrate is equivalent to 10 ppm nitrogen. The PHG of 3 ppm for nitrite is 1 ppm when expressed as nitrogen. The PHGs for nitrate and nitrite expressed as nitrogen have not changed. The combined nitrate/nitrite PHG of 10 ppm (as nitrogen), which accounts for the additive toxicity of nitrate and nitrite, also remains unchanged. It does not replace the individual values, and the maximum contribution from nitrite should not exceed 1 ppm nitrite-nitrogen. These PHGs protect against the occurrence of infant methemoglobinemia, a blood disorder that results in decreased oxygen distribution to tissues, as well as other effects, such as liver toxicity, that have been shown to occur at higher levels of exposure and in the general population.

NTP Information Cited

National Toxicology Program (NTP). 2001. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Nitrite (CASRN 7632-00-0) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 495. https://ntp.niehs.nih.gov/go/tr495abs

NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • May 11, 2018
  • Public Health Goals
7632-00-0
2018 OEHHA
Notice of Adoption of Reference Exposure Levels for Ethylene Glycol Mono-N-Butyl Ether

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting revised Reference Exposure Levels (RELs) for Ethylene Glycol mono-n-Butyl Ether (EGBE) (CAS No. 111-76-2) for use in the Air Toxics Hot Spots program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to EGBE in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposure.

NTP Information Cited
National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2-Butoxyethanol (CASRN 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 484. https://ntp.niehs.nih.gov/go/tr484abs

National Toxicology Program Nonneoplastic Lesion Atlas. Nose, Epithelium - Accumulation, Hyaline Droplet. Available: https://ntp.niehs.nih.gov/nnl/respiratory/nose/epaccum/index.htm [accessed October 2015]

  • Type: Notice
  • May 04, 2018
  • Air Toxics Hot Spots Program
111-76-2
2018 OEHHA
Current Proposition 65 No Significant Risk Levels (NSRLs) Maximum Allowable Dose Levels (MADLs)

Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65. In some instances, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements.

NTP Information Cited
Gold L, Slone T, Backman G, Magaw R, DaCosta M, Ames B (1987). Second chronological supplement to the Carcinogenic Potency Database: Standardized results of animal bioassays published through December 1984 and by the National Toxicology Program through May 1986. Environmental Health Perspectives 74: 237-329.­ https://ehp.niehs.nih.gov/doi/10.1289/ehp.8774237.

Gold L, Slone T, Backman G, Eisenberg S, DaCosta M, Wong M, Manley N, and Ames B (1990). Third chronological supplement to the Carcinogenic Potency Database: Standardized results of animal bioassays published through December 1986 and by the National Toxicology Program through June 1987. Environmental Health Perspectives 84: 215-285. https://ehp.niehs.nih.gov/doi/abs/10.1289/ehp.9084215.

National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Chlorendic Acid in F344 Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 304. N1H Publication No. 87-2560, US Department of Health and Human Services (DHEW), NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr304abs.

National Toxicology Program (NTP, 1991). Chemical Status Report. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/msr.

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of C.l. Basic Red 9 Monohydrochloride in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 196. NIH Publication No. 86-2541. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr196abs.

National Toxicology Program (NTP, 1982). Toxicology and Carcinogenesis Studies of D & C Red 9 in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 225. NIH Publication No. 82-1781. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr225abs.  

National Cancer Institute (NCI, 1980). Bioassay of 4,4'-0xydianiline for Possible Carcinogenicity. Carcinogenesis Technical Report Series No. 205. NIH Publication No. 80-1761. US Department of Health and Human Services, NCI Carcinogenesis Testing Program, and National Toxicology Program. https://ntp.niehs.nih.gov/go/tr205abs.  

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Diglycidyl Resorcinol Ether in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 257. NIH Publication No. 87-2513. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr257abs.  

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of Dimethylvinyl Chloride (1-chloro-2-methyl-propene) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 316. NIH Publication No. 86­ 2572. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr316abs.

National Toxicology Program (NTP, 1986). Toxicology and Carcinogenesis Studies of HC Blue 1 in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series; No. 271. NTIS Publication No. PB 86-114683. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr271abs.  

National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Hexachloroethane in F344/N Rats (Gavage Studies). NTP Technical Report Series No. 361. NTIS Publication No. 89-2816. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr361abs.

  • Type: Notice
  • April 17, 2018
  • Proposition 65
115-28-6
569-61-9
5160-02-1
101-80-4
101-90-6 513-37-1
2784-94-3
67-72-1
2018 OEHHA
Amendment to Section 25705 No Significant Risk Level - Glyphosate April 10, 2018

On April 6, 2018, the Office of Administrative Law approved an amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical glyphosate. The regulation will be effective on July 1, 2018. This regulation establishes a NSRL of 1100 micrograms per day for glyphosate.

NTP Information Cited
National Toxicology Program (NTP, 2015). Handbook for Preparing Report on Carcinogens Monographs. Office of the Report on Carcinogens, Division of the NTP, National Institute of Environmental Health Sciences, US Department of Health and Human Services. https://ntp.niehs.nih.gov/go/rochandbook.

  • Type: Notice
  • April 10, 2018
  • Proposition 65
1071-83-6
2018 CDC
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability for public comment on the drugs proposed for placement on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2018 (List), as well as the NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed Additions to the NIOSH Hazardous Drug List 2018
  • February 14, 2018
  • 83 FR 6563
N/A
2018 OEHHA
Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Bromodichloroacetic Acid

Notice is hereby given that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a Proposition 65 No Significant Risk Level (NSRL) of 0.95 micrograms per day for bromodichloroacetic acid, by amending Title 27, California Code of Regulations, section 25705(b).

NTP Information Cited
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). NTP Technical Report Series No. 583. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr583abs.

  • Type: Notice
  • January 26, 2018
  • Proposition 65
7113-14-7
2018 OEHHA
Notice of Intent to List: TRIM VX

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list TRIM VX as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
National Toxicology Program (NTP, 2016).  NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 591. US Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr591abs.  

  • Type: Notice
  • January 26, 2018
  • Proposition 65
N/A
2017 USDA
Information Collection; Qualified Products Lists for Fire Chemicals for Wildland Fire Management

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Qualified Products Lists for Fire Chemicals for Wildland Fire Management.

NTP Information Cited
NTP (National Toxicology Program). 2016. Report on Carcinogens, Fourteenth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc14.

  • Type: Notice; Request for Comment
  • November 04, 2017
  • 82 FR 57200
N/A
2017 CPSC
Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates

The United States Consumer Product Safety Commission (Commission or CPSC) issues this final rule prohibiting children’s toys and child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established permanent and interim prohibitions on the sale of certain consumer products containing specific phthalates. That provision also directed the CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives, other than those already permanently prohibited, should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. This rule fulfills that requirement.

NTP Information Cited
NTP (2015) Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration. National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC. January 2015. https://ntp.niehs.nih.gov/go/ohathandbook.

NTP (2016) Report on Carcinogens, Fourteenth Edition. National Toxicology Program, U.S. Department of Health and Human Services, Public Health Service. Research Triangle Park, NC.  https://ntp.niehs.nih.gov/go/roc14.

  • Type: Final Rule
  • October 27, 2017
  • 82 FR 49938
117-81-7
2017 OEHHA
Announcement of the Carcinogen Identification Committee Meeting Scheduled for November 2, 2017 and Availability of Hazard Identification Materials for Coumarin

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Carcinogen Identification Committee (CIC) advises and assists OEHHA in compiling the list of chemicals known to the state to cause cancer as required by Health and Safety Code section 25249.8. The Committee serves as the state’s qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

NTP Information Cited
NTP (1993a). National Toxicology Program, U.S. Department of Health and Human Services. Toxicology and carcinogenesis studies of coumarin (CAS No. 91-64-5) in F344/N rats and B6C3F1 mice (gavage studies). National Toxicology Program Technical Report Series No. 422. https://ntp.niehs.nih.gov/go/tr422abs.

NTP (1993b). National Toxicology Program, U.S. Department of Health and Human Services. Toxicology and Carcinogenesis Studies of 3,4-Dihydrocoumarin (CAS No. 119-84-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies). National Toxicology Program Technical Report Series No. 423. https://ntp.niehs.nih.gov/go/tr423abs.

NTP (1997). National Toxicology Program, U.S. Department of Health and Human Services. Effect of Dietary Restriction on Toxicology and Carcinogenesis Studies in F344/N Rats and B6C3F1 Mice. National Toxicology Program Technical Report Series No. 460. https://ntp.niehs.nih.gov/go/tr460abs.

NTP (1999a). Rats: Fischer F344 (for study years 1984-1994). Historical Controls Database, National Toxicology Program, from https://ntp.niehs.nih.gov/go/historical_controls.

NTP (1999b). Mice: B6C3F1 (for study years 1984-1994). Historical Controls Database, National Toxicology Program, from https://ntp.niehs.nih.gov/go/historical_controls.

  • Type: Notice
  • August 18, 2017
  • Proposition 65
91-64-5
2017 OEHHA
Chemical Listed Effective July 7, 2017 as Known to the State of California to Cause Cancer: Penta­bromo­di­phenyl Ether Mixture [DE-71 (Technical Grade)]

Effective July 7, 2017, OEHHA is adding penta­bromo­di­phenyl ether mixture [DE-71 (technical grade)] to the list of chemicals known to the state to cause cancer for purposes of Proposition 65, under the "authoritative bodies" mechanism.

NTP Information Cited
National Toxicology Program (NTP). 2016. NTP technical report on the toxicology studies of a pentabromodiphenyl ether mixture [DE-71 (technical grade)] (CASRN 32534-81-9) in F344/N rats and B6C3F1/N mice and toxicology and carcinogenesis studies of a pentabromodiphenyl ether mixture [DE-71 (technical grade)] in Wistar Han [Crl:WI(Han)] rats and B6C3F1/N mice (gavage studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 589. https://doi.org/10.22427/NTP-TR-589.

  • Type: Notice
  • July 07, 2017
  • Proposition 65
32534-81-9
2017 OEHHA
Notice of Amendment to Section 25705, No Significant Risk Level for Styrene

On May 4, 2017, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25705, No Significant Risk Level (NSRL) for the chemical styrene.  The regulation will be effective on July 1, 2017.  This regulation establishes a No Significant Risk Level of 27 micrograms per day for styrene for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.  https://ntp.niehs.nih.gov/go/roc12.

  • Type: Notice
  • May 11, 2017
  • Proposition 65
100-42-5
2017 OEHHA
Notice of Intent to List Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)]

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list pentabromodiphenyl ether mixture [DE-71 (technical grade)] as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
National Toxicology Program (NTP, 2016). Toxicology Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] (CASRN 32534-81-9) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of a Pentabromodiphenyl Ether Mixture [DE-71 (Technical Grade)] in Wistar Han [Crl:WI(Han)] Rats and B6C3F1/N Mice (Gavage Studies). Technical Report Series No. 589. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. https://doi.org/10.22427/NTP-TR-589.

  • Type: Notice
  • May 05, 2017
  • Proposition 65
32534-81-9
2017 CDC
Proposed Data Collection Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Childhood Blood Lead Surveillance (CBLS) and Adult Blood Lead Epidemiology and Surveillance (ABLES).'' The National Center for Environmental Health (NCEH) is leading a new three-year information collection request (ICR) that covers two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH). CDC requests an annual time burden of 1,120 burden hours for both collections.

NTP Information Cited
NTP monograph on health effects of low-level lead. NTP Monogr. 2012 Jun;(1):xiii, xv-148. PMID: 23964424. https://pubmed.ncbi.nlm.nih.gov/23964424/.

  • Type: Notice with Comment Period
  • April 06, 2017
  • 82 FR 16839
7439-92-1
2017 OEHHA
Amendment to Section 25805, Maximum Allowable Dose Level (Oral) for Ethylene Glycol (Ingested)

On April 4, 2017, the Office of Administrative Law approved the amendment of Title 27, California Code of Regulations, section 25805, Maximum Allowable Dose Level (MADL) for the chemical ethylene glycol (ingested).  The regulation will be effective on July 1, 2017.  This regulation establishes a MADL of 8,700 (oral) micrograms per day for ethylene glycol (ingested).  

NTP Information Cited
National Toxicology Program. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. NTP CERHR MON. 2004 Jan;(11):1-III36. PubMed PMID: 16015391. https://pubmed.ncbi.nlm.nih.gov/16015391/.

  • Type: Notice
  • April 06, 2017
  • Proposition 65
7439-92-1
2017 EPA
Tetra­bromo­bis­phenol A (TBBPA); TSCA Section 21 Petition

This document provides the reasons for EPA's response to a petition it received under the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from Earthjustice, Natural Resources Defense Council, Toxic-Free Future, Safer Chemicals, Healthy Families, BlueGreen Alliance, and Environmental Health Strategy Center on December 13, 2016. The petitioners requested that EPA issue an order under TSCA section 4, requiring that testing be conducted by manufacturers (which includes importers) and processors on tetra­bromo­bis­phenol A (``TBBPA'') (CAS No. 79-94-7). After careful consideration, EPA denied the TSCA section 21 petition for the reasons discussed in this document.

NTP Information Cited
NTP (National Toxicology Program) (n.d.). Modified One-Generation Studies. (retrieved in 2016). https://ntp.niehs.nih.gov/ntp/test_info/mog_guidance_508.pdf.

  • Type: Proposed Rule
  • March 17, 2017
  • 82 FR 14171
2017 EPA
Oxytetracycline; Pesticide Tolerances for Emergency Exemptions

This regulation establishes a time-limited tolerance for residues of oxytetracycline in or on fruit, citrus, group 10-10. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in citrus production. This regulation establishes a maximum permissible level for residues of oxytetracycline in or on the commodities in this crop group. The time-limited tolerance expires on December 31, 2019.

NTP Information Cited
National Toxicology Program (NTP). 1987. NTP technical report on toxicology and carcinogenesis studies of oxytetracycline hydrochloride (CASRN 2058-46-0) in F344/N rats and B6C3F1 mice (feed studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 315. https://ntp.niehs.nih.gov/go/tr315abs.

  • Type: Final Rule
  • March 10, 2017
  • 82 FR 14171
79-57-2
2017 EPA
Isoamyl Acetate; Exemption from the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of isoamyl acetate (CAS Reg. No. 123-92-2) when used as an inert ingredient (buffering agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. The Technology Sciences Group on behalf of the Jeneil Biosurfactant Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance.

NTP Information Cited
National Toxicology Program (NTP). 1994. Summary of data for chemical selection isoamyl acetate CASRN 123-92-2. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/isoamylacetate_508.pdf.

  • Type: Final Rule
  • March 10, 2017
  • 82 FR 14617
123-92-2
2017 EPA
Fluoride Chemicals in Drinking Water; TSCA Section 21 Petition; Reasons for Agency Response

This document announces the availability of EPA's response to a petition it received on November 23, 2016, under section 21 of the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from the Fluoride Action Network, Food & Water Watch, Organic Consumers Association, the American Academy of Environmental Medicine, the International Academy of Oral Medicine and Toxicology, and other individual petitioners. The TSCA section 21 petition requested that EPA exercise its authority under TSCA section 6 to ``prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.'' After careful consideration, EPA has denied the TSCA section 21 petition for the reasons discussed in this document.

NTP Information Cited
National Toxicology Program (NTP). 2016. NTP research report on systematic literature review on the effects of fluoride on learning and memory in animal studies. Research Triangle Park, NC: National Toxicology Program. Research Report 1. https://doi.org/10.22427/NTP-RR-1.

  • Type: Proposed Rule
  • February 27, 2017
  • 82 FR 11878
7681-49-4
2017 OEHHA
Notice of Adoption of Reference Exposure Levels for Carbonyl Sulfide

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for carbonyl sulfide (COS) for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to COS in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposure.

NTP Information Cited
NTP (2010) Testing Status of Agents. Carbonyl sulfide. https://ntp.niehs.nih.gov/go/ts-m950074.

  • Type: Notice
  • February 21, 2017
  • Air Toxics Hot Spots Program
2017 EPA
Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This proposed rule identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA is proposing that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required ‘‘form and criteria’’ applicable to such manufacturer requests.

NTP Information Cited
National Toxicology Program (NTP). 2015a. Handbook for conducting a literature-based health assessment using Office of Health Assessment and Translation (OHAT) approach for systematic review and evidence integration. National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Office of Health Assessment and Translation (OHAT). https://ntp.niehs.nih.gov/go/ohathandbook.

National Toxicology Program (NTP). 2015b. OHAT risk of bias tool. https://ntp.niehs.nih.gov/go/riskbias.

  • Type: Proposed Rule
  • January 19, 2017
  • 82 FR 7562
2017 EPA
Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This proposed rule identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. EPA is proposing that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High- Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. The proposed rule also includes the required "form and criteria'' applicable to such manufacturer requests.

NTP Information Cited
National Toxicology Program (NTP). 2015a. Handbook for conducting a literature-based health assessment using Office of Health Assessment and Translation (OHAT) approach for systematic review and evidence integration. National Institute of Environmental Health Sciences, Division of the National Toxicology Program, Office of Health Assessment and Translation (OHAT). https://ntp.niehs.nih.gov/go/ohathandbook.

National Toxicology Program (NTP). 2015b. OHAT risk of bias tool. https://ntp.niehs.nih.gov/go/riskbias.

  • Type: Proposed Rule
  • January 19, 2017
  • 82 FR 7562
2017 EPA
National Primary Drinking Water Regulations; Announcement of the Results of EPA’s Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues

The Safe Drinking Water Act (SDWA) requires the U.S. Environmental Protection Agency (EPA) to conduct a review every six years of existing national primary drinking water regulations (NPDWRs) and determine which, if any, need to be revised. The purpose of the review, called the Six- Year Review, is to evaluate current information for regulated contaminants to determine if there is new information on health effects, treatment technologies, analytical methods, occurrence and exposure, implementation and/or other factors that provides a health or technical basis to support a regulatory revision that will improve or strengthen public health protection. EPA has completed a detailed review of 76 NPDWRs and at this time has determined that eight NPDWRs are candidates for regulatory revision. The eight NPDWRs are included in the Stage 1 and the Stage 2 Disinfectants and Disinfection Byproducts Rules, the Surface Water Treatment Rule, the Interim Enhanced Surface Water Treatment Rule and the Long Term 1 Enhanced Surface Water Treatment Rule. EPA requests comments on the eight NPDWRs identified as candidates for revision and will consider comments and data as it proceeds with determining whether further action is needed. In addition, as part of this Six-Year Review, EPA identified 12 other NPDWRs that were or continue to be addressed in recently completed, ongoing or pending regulatory actions. EPA thus excluded those 12 NPDWRs from detailed review. This document is not a final regulatory decision, but rather the initiation of a process that will involve more detailed analyses of factors relevant to deciding whether a rulemaking to revise an NPDWR should be initiated.

NTP Information Cited
National Toxicology Program (NTP). 2005. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Chlorate (CASRN 7775-09-9) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 517. https://ntp.niehs.nih.gov/go/tr517abs

National Toxicology Program (NTP). 2007. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CASRN 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 537. https://ntp.niehs.nih.gov/go/tr537abs

National Toxicology Program (NTP). 2009. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Bromochloroacetic acid (CASRN 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking water studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 549. https://ntp.niehs.nih.gov/go/tr549abs  

National Toxicology Program (NTP). 2014. NTP Technical Report on the Toxicology Studies of Bromodichloroacetic Acid in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 583. https://ntp.niehs.nih.gov/go/tr583abs 

National Toxicology Program (NTP). 2016. NTP research report on systematic literature review on the effects of fluoride on learning and memory in animal studies. Research Triangle Park, NC: National Toxicology Program. Research Report 1. https://doi.org/10.22427/NTP-RR-1.

  • Type: Notice; request for public comment
  • January 11, 2017
  • 82 FR 3518
7775-09-9
631-64-1
5589-96-8
71133-14-7
7681-49-4
2017 EPA
Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)

Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in vapor degreasing and EPA’s proposed determination is that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.

NTP Information Cited
National Toxicology Program (NTP, 2011). Trichloroethylene. Report on Carcinogens, Twelfth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, https://ntp.niehs.nih.gov/ntp/roc/content/profiles/trichloroethylene.pdf.

  • Type: Proposed Rule
  • January 11, 2017
  • 82 FR 7432
79-01-6 
2017 EPA
Granting Petitions to Add n-Propyl Bromide to the List of Hazardous Air Pollutants

The Environmental Protection Agency (EPA) is publishing a draft notice of the rationale for granting petitions to add n-propyl bromide (nPB), also known as 1-bromopropane (1–BP), (Chemical Abstract Service No. 106–94–5) to the list of hazardous air pollutants (HAP) contained in section 112(b)(1) of the Clean Air Act (CAA). The Halogenated Solvents Industry Alliance (HSIA) and New York State Department of Environmental Conservation (NYSDEC) submitted petitions requesting that nPB be added to the list of HAP. In response to the EPA requests for additional data, HSIA subsequently supplemented its petition. Petitions to add a substance to the list of HAP are permitted under the CAA section 112(b)(3). Based on the EPA’s evaluation of the petitioners’ showing concerning potential hazards, emissions, and atmospheric dispersion modeling that provided estimates of ambient concentrations of nPB, the EPA has determined that there is adequate evidence to support a determination that emissions and ambient concentrations of nPB may reasonably be anticipated to cause adverse health effects.

NTP Information Cited
NTP (National Toxicology Program). 2014. Bromopropane. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bromopropane.pdf

  • Type: Notice; request for public comment
  • January 09, 2017
  • 82 FR 2354
106-94-5
2017 NAS
New Report Calls for Use of Emerging Scientific Data to Better Assess Public Health Risks

Recent scientific and technological advances have the potential to improve assessment of public health risks posed by chemicals, yet questions remain how best to integrate the findings from the new tools and methods into risk assessment. A new National Academies of Sciences, Engineering, and Medicine report recommends approaches for using 21st century science to evaluate the many factors that lead to health risks and disease, laying the groundwork for a new direction in risk assessment that acknowledges the complexity of disease causation.

NTP Information Cited
NTP (National Toxicology Program). 2004. A National Toxicology Program for the 21st Century: A Roadmap for the Future [online]. https://ntp.niehs.nih.gov/ntp/about_ntp/ntpvision/ntproadmap_508.pdf.

  • Type: Notice
  • January 05, 2017
2016 EPA
Trichloroethylene; Regulation of Certain Uses Under TSCA

Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities. EPA has preliminarily determined that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture, processing, and distribution in commerce of TCE for use in aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited record keeping.

NTP Information Cited

NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed Rule
  • December 16, 2016
  • 81 FR 91592
79-34-5
2016 EPA
Formaldehyde Emission Standards for Composite Wood Products

EPA is issuing a final rule to implement the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to the Toxic Substances Control Act (TSCA). The purpose of TSCA Title VI is to reduce formaldehyde emissions from composite wood products, which will reduce exposures to formaldehyde and result in benefits from avoided adverse health effects. This final rule includes formaldehyde emission standards applicable to hardwood plywood, medium-density fiberboard, and particleboard, and finished goods containing these products, that are sold, supplied, offered for sale, or manufactured (including imported) in the United States. This final rule includes provisions relating to, among other things, laminated products, products made with no-added formaldehyde resins or ultra low-emitting formaldehyde resins, testing requirements, product labeling, chain of custody documentation and other recordkeeping requirements, enforcement, import certification, and product inventory sell-through provisions, including a product stockpiling prohibition. This final rule also establishes a third-party certification program for hardwood plywood, medium-density fiberboard, and particleboard and includes procedures for the accreditation of third-party certifiers and general requirements for accreditation bodies and third-party certifiers.

NTP Information Cited

NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • December 12, 2016
  • 81 FR 89674
50-0-0
2016 OEHHA
Chemical Listed Effective October 21, 2016 as Known to the State of California to Cause Cancer: Pentachlorophenol and By-Products of its Synthesis (Complex Mixture)

Effective October 21, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding pentachlorophenol and by-products of its synthesis (complex mixture) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • October 21, 2016
  • Proposition 65
87-86-5
2016 OEHHA
Final Technical Support Document on Updated Public Health Goal for Antimony in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is announcing the publication of the updated Public Health Goal (PHG) for antimony in drinking water. A PHG is the level of a drinking water contaminant at which adverse health effects are not expected to occur from a lifetime of exposure. The California Safe Drinking Water Act of 1996 requires OEHHA to develop PHGs based exclusively on public health considerations. PHGs published by OEHHA are considered by the State Water Resources Control Board in setting drinking water standards (Maximum Contaminant Levels, or MCLs) for California.

NTP Information Cited
National Toxicology Program (NTP). 1995. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Toxicology and Carcinogenesis Studies of Hydroquinone (CASRN 123-31-9) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 366. https://ntp.niehs.nih.gov/go/tr366abs

National Toxicology Program (NTP). 1992. NTP Technical Report on the Toxicity Studies of Toxicity Studies of Antimony Potassium Tartrate (CASRN 28300-74-5) in F344/N Rats and B6C3F1 Mice (Drinking Water and Intraperitoneal Injection Studies). Research Triangle Park, NC: National Toxicology Program. Toxicity Report 11. https://ntp.niehs.nih.gov/go/tox11abs

  • Type: Notice
  • September 23, 2016
  • Public Health Goals
123-31-9
28300-74-5
2016 VA
Diseases Associated with Exposure to Contaminants in the Water Supply at Camp Lejeune

The Department of Veterans Affairs (VA) proposes to amend its adjudication regulations relating to presumptive service connection to add certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953 to December 31, 1987. The chemical compounds involved have been associated by various scientific organizations with the development of certain diseases. This proposed rule would establish that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period, and who have been diagnosed with any of eight associated diseases, are presumed to have a service-connected disability for purposes of entitlement to VA benefits. In addition, VA proposes to establish a presumption that these individuals were disabled during the relevant period of service, thus establishing active military service for benefit purposes. Under this proposed presumption, affected former reservists and National Guard members would have veteran status for purposes of entitlement to some VA benefits. This proposed amendment would implement a decision by the Secretary of Veterans Affairs that service connection on a presumptive basis is warranted for claimants who served at Camp Lejeune during the relevant period and for the requisite amount of time and later develop certain diseases. The Secretary’s decision is supported by the conclusions of internationally recognized scientific authorities that strong evidence exists establishing a relationship between exposure to certain volatile organic compounds (VOCs) that were in the water at Camp Lejeune and later development of certain disabilities.

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

National Toxicology Program (NTP). 2015. Report on Carcinogens Monograph on Trichloroethylene (CASRN 79-01-6). Research Triangle Park, NC: National Toxicology Program. RoC Monograph 13. https://doi.org/10.22427/ROC-MGRAPH-13

  • Type: Proposed Rule
  • September 09, 2016
  • 81 FR 62419
79-01-6
2016 HUD
Requirements for Notification, Evaluation and Reduction of Lead-Based Paint Hazards in Federally Owned Residential Property and Housing Receiving Federal Assistance; Response to Elevated Blood Lead Levels

This proposed rule would amend HUD’s lead-based paint regulations on reducing blood lead levels in children under age 6 who reside in federally-owned or -assisted pre-1978 housing and formally adopt the revised definition of ‘‘elevated blood lead levels’’ in children under the age of 6 in accordance with guidance of the Centers for Disease Control and Prevention (CDC), and establish more comprehensive testing and evaluation procedures for the housing where such children reside. In 2012, the CDC issued guidance revising its definition of elevated blood lead level in children under age 6 to be a blood lead level based on the distribution of blood lead levels in the national population. Since CDC’s revision of its definition, HUD has applied the revised definition to funds awarded under its Lead-Based Paint Hazard Control grant program and its Lead Hazard Reduction Demonstration grant program, and has updated its Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing to reflect this definition. CDC is continuing to consider, with respect to evolution of scientific and medical understanding, how best to identify childhood blood lead levels for which environmental interventions are recommended. Through this rule, HUD formally adopts through regulation the CDC’s approach to the definition of ‘‘elevated blood lead levels’’ in children under the age of 6 and addresses the additional elements of the CDC guidance pertaining to assisted housing.

NTP Information Cited
National Toxicity Program (NTP). 2012. Monograph on Health Effects of Low-level Lead. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf 

  • Type: Proposed Rule
  • September 01, 2016
  • 81 FR 60304
7439-92-1
2016 OEHHA
1-Bromopropane Listed Effective August 5, 2016, as Known to the State of California to Cause Cancer

Effective August 5, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding 1-bromopropane (CAS No. 106-94-5) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP). 2011. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CASRN 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 564. https://ntp.niehs.nih.gov/go/tr564abs

  • Type: Notice
  • August 05, 2016
  • Proposition 65
106-94-5
2016 OEHHA
Bromodichloroacetic Acid Listed Effective July 29, 2016 as Known to the State of California to Cause Cancer

Effective July 29, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding bromodichloroacetic acid (CAS No. 71133-14-7) to the list of chemicals known to the state to cause cancer for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP). 2015. NTP Technical Report on the Toxicology Studies of Bromodichloroacetic Acid (CASRN 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid (CASRN 71133-14-7) in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 583. https://doi.org/10.22427/NTP-TR-583

  • Type: Notice
  • July 29, 2016
  • Proposition 65
71133-14-7
2016 DOE
Chronic Beryllium Disease Prevention

The Department of Energy (DOE or the Department) is proposing to amend its current chronic beryllium disease prevention program regulation. The proposed amendments would improve and strengthen the current provisions and continue to be applicable to DOE Federal and contractor employees who are, were, or potentially were exposed to beryllium at DOE sites.

NTP Information Cited
NTP (National Toxicology Program). 2014. Beryllium and Beryllium Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/berylliumandberylliumcompounds.pdf

  • Type: Notice of Proposed Rulemaking and Public Hearings
  • June 07, 2016
  • 81 FR 12547
7440-41-7
2016 OEHHA
Notice of Intent to List Bromodichloroacetic Acid

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical bromodichloroacetic acid as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP). 2015. NTP Technical Report on the Toxicology Studies of Bromodichloroacetic Acid (CASRN 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid (CASRN 71133-14-7) in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 583. https://doi.org/10.22427/NTP-TR-583

  • Type: Notice
  • May 27, 2016
  • Proposition 65
71133-14-7
2016 OEHHA
Styrene Listed Effective April 22, 2016 As Known To The State Of California To Cause Cancer

Effective April 22, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding styrene (CAS No. 100-42-5) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of styrene is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

NTP Information Cited
NTP (National Toxicology Program). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • April 22, 2016
  • Proposition 65
100-42-5
2016 OEHHA
Proposed Amendment to Section 25705, Specific Regulatory Levels Posing No Significant Risk: Styrene

The listing of styrene is based on formal identification by the National Toxicology Program (NTP), an authoritative body, that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 27, Cal. Code of Regs., section 25306.

NTP Information Cited
NTP (National Toxicology Program). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • April 22, 2016
  • Proposition 65
100-42-5
2016 OEHHA
Notice Of Emergency Action To Amend Section 25603.3 Title 27, California Code Of Regulations Warnings For Exposures To Bisphenol A From Canned And Bottled Foods And Beverages

On May 11, 2015, Bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity based on the female reproductive endpoint. Female reproductive toxicity occurs when a chemical damages any aspect of the female reproductive system. BPA is commonly used in certain linings of metal cans and lids of glass bottles containing food and beverages. Under Proposition 65, one year after the listing, beginning May 11, 2016, warnings are required for all exposures to BPA unless the person causing the exposure can show that the exposure when multiplied by 1,000 times has no observable effect.

NTP Information Cited
National Toxicology Program (NTP). 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf

  • Type: Notice
  • April 19, 2016
  • Proposition 65
80-05-7
2016 OEHHA
Notice Of Proposed Rulemaking, Amendment To Section 25805, Specific Regulatory Levels: Chemicals Causing Reproductive Toxicity - Ethylene Glycol (Ingested)

OEHHA reviewed the studies identified in the NTP-CERHR Monograph that provide the basis for the listing, and conducted a literature search for any other relevant studies or reports published after the NTP-CERHR review was completed. Additional relevant studies were identified and reviewed by OEHHA. This is discussed in more detail in the initial statement of reasons for this proposed regulatory amendment.

NTP Information Cited
National Toxicology Program (NTP). 2004. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/egpg/ethylene/eg_monograph.pdf

  • Type: Notice
  • April 08, 2016
  • Proposition 65
107-21-1
2016 EPA
Diflubenzuron; Pesticide Tolerances

This regulation establishes tolerances for residues of diflubenzuron in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CASRN 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 351. https://ntp.niehs.nih.gov/go/tr351abs

  • Type: Final Rule
  • February 12, 2016
  • 81 FR 7466
106-47-8
2016 EPA
Benzyl acetate; Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of benzyl acetate (CAS Reg. No. 140–11–4), when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only under 40 CFR 180.920. Technology Sciences Group, on behalf of the Huntsman Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of benzyl acetate.

NTP Information Cited
National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Benzyl Acetate (CASRN 140-11-4) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 431. https://ntp.niehs.nih.gov/go/tr431abs

  • Type: Final Rule
  • February 12, 2016
  • 81 FR 7473
140-11-4
2015 EPA
Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting

The Environmental Protection Agency (EPA) is adding 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropane has been classified by the National Toxicology Program in their 13th Report on Carcinogens as ‘‘reasonably anticipated to be a human carcinogen.’’ The EPA has determined that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

National Toxicology Program (NTP). 2013. Report on Carcinogens. Monograph on 1-Bromopropane. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/roc/thirteenth/monographs_final/1bromopropane_508.pdf

  • Type: Final Rule
  • November 23, 2015
  • 80 FR 72906
106–94–5
2015 OEHHA
Notice of Intent to List Pentachlorophenol and By-Products of Its Synthesis (Complex Mixture)

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list “pentachlorophenol and by-products of its synthesis (complex mixture)” as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures (CASRN 87-86-5) in B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 349. https://ntp.niehs.nih.gov/go/tr349abs

NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • October 30, 2015
  • Proposition 65
87-86-5
2015 EPA
Ethylene Glycol Monobutyl Ether; Community Right-To-Know Toxic Chemical Release Reporting

Environmental Protection Agency (EPA) is denying a petition to remove ethylene glycol monobutyl ether (EGBE) from the category Certain Glycol Ethers under the list of chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. EPA has reviewed the available data on this chemical and has determined that EGBE does not meet the deletion criterion of EPCRA section 313(d)(3). Specifically, EPA is denying this petition because EPA’s review of the petition and available information resulted in the conclusion that EGBE meets the listing criterion of EPCRA section 313(d)(2)(B) due to its potential to cause serious or irreversible chronic health effects in humans, specifically, liver toxicity and concerns for hematological effects.

NTP Information Cited
National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CASRN 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 484. https://ntp.niehs.nih.gov/go/tr484abs

National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Acetonitrile (CASRN 75-05-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 447. https://ntp.niehs.nih.gov/go/tr447abs

National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicity Studies of Ethylene Glycol Ethers 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CASRNs 109-86-4, 110-80-5, and 111-76-2) Administered in Drinking Water to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 26. https://ntp.niehs.nih.gov/go/tox26abs

  • Type: Denial of Petition
  • October 08, 2015
  • 80 FR 60818
98-01-1
98-00-0
110-00-9
2015 OEHHA
Prioritization: Chemicals for Consultation by the Developmental and Reproductive Toxicant Identification Committee

This notice announces the beginning of a 45-day public comment period on the five chemicals listed below. These chemicals will be discussed at the November 9, 2015 meeting of the Proposition 65 Developmental and Reproductive Toxicant Identification Committee (DARTIC). The five chemicals are: • Nickel • Pentachlorophenol • Perfluorooctanoic acid (PFOA) • Perfluorooctane sulfonate (PFOS) • Tetrachloroethylene

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • August 28, 2015
  • Proposition 65
7440-02-0
2015 OEHHA
Availability of Hazard Identification Materials For Nitrapyrin And Di­lamino­toluenes. "Di­lamino­toluene (Mixed)" And Nitrapyrin Are Under Review For Possible Delisting

OEHHA is referring nitrapyrin and di­lamino­toluene (mixed) to the Carcinogen Identification Committee (CIC), the state’s qualified experts for carcinogenicity determinations under Proposition 65, for review.

NTP Information Cited
National Toxicology Program (NTP). 1990. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Toluene (CASRN 108-88-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 371. https://ntp.niehs.nih.gov/go/tr371abs

National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures (CASRN 87-86-5) in B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 349. https://ntp.niehs.nih.gov/go/tr349abs

National Cancer Institute (NCI). 1978. NCI Technical Report on the Bioassay of 2,5-Toluenediamine Sulfate (CASRN 6369-59-1) for Possible Carcinogenicity . Bethesda, MA: National Cancer Institute. Technical Report 126. https://ntp.niehs.nih.gov/go/tr126abs

  • Type: Notice
  • August 28, 2015
  • Proposition 65
95-80-7
6369-59-1
2015 OSHA
Occupational Exposure to Beryllium and Beryllium Compounds

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds and promulgate a substance-specific standard for general industry regulating occupational exposure to beryllium and beryllium compounds. This document proposes a new permissible exposure limit (PEL), as well as ancillary provisions for employee protection such as methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. In addition, OSHA seeks comment on a number of alternatives, including a lower PEL, that could affect construction and maritime, as well as general industry.

NTP Information Cited
NTP (National Toxicology Program). 2014. Beryllium and Beryllium Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/berylliumandberylliumcompounds.pdf

National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Talc (CASRN 14807-96-6) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 421. https://ntp.niehs.nih.gov/go/tr421abs

National Toxicology Program (NTP). 1999. NTP Report on Carcinogens Background Document for Beryllium and Beryllium Compounds. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/newhomeroc/roc10/be_no_appendices_508.pdf

NTP (National Toxicology Program). 2002. Report on Carcinogens, Tenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed rule; Request for Comments
  • August 07, 2015
  • 80 FR 47566
14807-96-6
7440-41-7
2015 OEHHA
Notice of Intent to List Furfuryl Alcohol

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list furfuryl alcohol as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986

NTP Information Cited
National Toxicology Program (NTP). 1990. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfural (CASRN 98-01-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 382. https://ntp.niehs.nih.gov/go/tr382abs

National Toxicology Program (NTP). 1999. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfuryl Alcohol (CARN 98-00-0) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 482. https://ntp.niehs.nih.gov/go/tr482abs

National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furan (CASRN 110-00-9) in F344/N Rats and B6C3F1 Mice(Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 402. https://ntp.niehs.nih.gov/go/tr402abs

  • Type: Notice
  • July 22, 2015
  • Proposition 65
98-01-1
98-00-0
110-00-9
2015 OEHHA
Petition to Amend

Pursuant to California Government Code section 11340.6, petitioners Mateel Environmental Justice Foundation, Californians for Alternatives to Toxics, Ecological Rights Foundation and Center for Environmental Health petition the California Office of Environmental Health Hazard Assessment to amend CCR, title 27, section 27001(b) to add glyphosate, malathion, tetrachlorvinphos and parathion to the chemicals listed under that section as known to the State to cause cancer.

NTP Information Cited
National Cancer Institute (NCI). 1979. NCI Technical Report on the Bioassay of Parathion (CASRN 56-38-2) for Possible Carcinogenicity . Bethesda, MA: National Cancer Institute. Technical Report 070. https://ntp.niehs.nih.gov/go/tr070abs

  • Type: Notice
  • July 17, 2015
  • Proposition 65
56-38-2
2015 OEHHA
Notice of Intent to List: 1-Bromopropane

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list 1-bromopropane as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
National Toxicology Program (NTP). 2011. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CASRN 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 564. https://ntp.niehs.nih.gov/go/tr564abs

  • Type: Notice
  • July 10, 2015
  • Proposition 65
109-94-5
2015 OEHHA
Chemical Listed Effective June 19, 2015 as Known to the State of California to Cause Reproductive Toxicity: Ethylene Glycol (Ingested)

Effective June 19, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) is adding ethylene glycol (ingested) (CAS No. 107-21-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65.

NTP Information Cited
National Toxicology Program (NTP). 2004. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/egpg/ethylene/eg_monograph.pdf

  • Type: Notice
  • June 19, 2015
  • Proposition 65
107-21-1
2015 NRDC
NRDC, Others Petition FDA to Ban Eight Carcinogenic Flavorings in Food

Eight synthetic flavorings—which may be found in ice cream, baked goods, candy and beverages—are known to cause cancer in lab animals, and should be banned by the U.S. Food and Drug Administration, a coalition of leading health groups said in a petition filed with the agency today.

NTP Information Cited
National Toxicology Program (NTP). 2006. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Benzophenone (CASRN 119-61-9) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 533. https://ntp.niehs.nih.gov/go/tr533abs

National Toxicology Program (NTP). 2000. NTP Report on Carcinogens Background Document for Methyleugenol. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/newhomeroc/roc10/me_no_appendices_508.pdf

National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Methyleugenol (CASRN 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 491. https://ntp.niehs.nih.gov/go/tr491abs

National Toxicology Program (NTP). 2010. NTP Technical Report on the Toxicology and Carcinogenesis Studies of beta-Myrcene (CASRN 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 557. https://ntp.niehs.nih.gov/go/tr557abs

National Toxicology Program (NTP). 2011. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Pulegone (CARN 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 563. https://ntp.niehs.nih.gov/go/tr563abs

National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Pyridine (CASRN 110-86-1) in F344/N Rats, Wistar Rats, and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 470. https://ntp.niehs.nih.gov/go/tr470abs

NTP (National Toxicology Program). 2014. Styrene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/styrene.pdf

National Toxicology Program (NTP). 2008. NTP Report on Carcinogens Background Document for Styrene. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/roc/twelfth/2010/finalbds/styrene_final_508.pdf

National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2,4-Hexadienal (CASRN 142-83-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 509. https://ntp.niehs.nih.gov/go/tr509abs

  • Type: Notice
  • June 10, 2015
  • NRDC
119-61-9
140-88-5
93-15-2
123-35-3
89-82-7 110-86-1
100-42-5
142-83-6
2015 ATSDR
Toxicological Profile for Formaldehyde

The ATSDR toxicological profile succinctly characterizes the toxicology and adverse health effects information for the toxic substance. Each peer-reviewed profile identifies and reviews the key literature that describes a substance's toxicological properties.

NTP Information Cited

NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

NTP (National Toxicology Program). 2005. Cadmium and Cadmium Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/cadmium.pdf

NTP (National Toxicology Program). 2005. Chromium Hexavalent Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/chromiumhexavalentcompounds.pdf

  • Type: Notice
  • May 12, 2015
  • 73 FR 66047
NA
2015 FDA
Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.

NTP Information Cited
National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Diethanolamine (CASRN 111-42-2) in F344/N Rats and B6C3F1 Mice (Dermal Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 478. https://ntp.niehs.nih.gov/go/tr478abs

National Toxicology Program (NTP). 1995. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CASRN 121-54-0) in F344/N Rats and B6C3F1 Mice (Dermal Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 438. https://ntp.niehs.nih.gov/go/tr438abs

National Toxicology Program (NTP). 2004. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Urethane (CASRN 51-79-6), Ethanol (CASRN 64-17-5), and Urethane/Ethanol in B6C3F 1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 510. https://ntp.niehs.nih.gov/go/tr510abs

National Toxicology Program (NTP). 1988. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 330. https://ntp.niehs.nih.gov/go/tr330abs

  • Type: Proposed Rule
  • May 01, 2015
  • 80 FR 25166
121-54-0
51-79-6
64-17-5
136-77-6
2015 OEHHA
Hazard Identification Materials for Consideration of the Female Reproductive Toxicity of Bisphenol A

Bisphenol A (BPA) will be considered for listing at the next meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) scheduled for May 7, 2015 in Sacramento. At this meeting,, the DARTIC will consider whether BPA "has been clearly shown through scientifically valid testing according to generally accepted principles to cause female reproductive toxicity".

NTP Information Cited

National Toxicology Program (NTP). 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf

National Toxicology Program CLARITY-BPA Program. https://ntp.niehs.nih.gov/go/bpa [accessed July 2015]

  • Type: Notice
  • April 23, 2015
  • Proposition 65
80-05-7
2015 OEHHA
Meeting Synopsis and Slide Presentation for the Carcinogen Identification Committee Meeting Held on November 19,2014

The Office of Environmental Health Hazard Assessment (OEHHA) convened a meeting of the Proposition 65 Carcinogen Identification Committee (CIC) on November 19, 2014, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. The Committee considered whether or not dibenzanthracenes (as a chemical group), dibenz[a,c]anthracene, dibenz[a,j]anthracene, and N-nitrosomethyl-n-alkylamines with alkyl chain lengths of 3 through 12 and 14 carbons should be listed under Proposition 65 as known to the state to cause cancer.

NTP Information Cited
NTP (National Toxicology Program). 1980. Report on Carcinogens, First Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • April 20, 2015
  • Proposition 65
53-70-3
2015 EPA
Addition of 1-Bromopropane; Community Right-To-Know Toxic Chemical Release Reporting

The Environmental Protection Agency (EPA) is proposing to add 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropance has been classified by the National Toxicology Program in their 13th Report on Carcinogens as “reasonably anticipated to be human carcinogen.” EPA believes that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, 1-bromopropane is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

National Toxicology Program (NTP). 2013. Report on Carcinogens. Monograph on 1-Bromopropane. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/roc/thirteenth/monographs_final/1bromopropane_508.pdf

NTP (National Toxicology Program). 2014. 1-Bromopropane. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bromopropane.pdf

  • Type: Proposed Rule
  • April 15, 2015
  • 80 FR 20189
109-94-5
2015 OEHHA
Chemical Listed Effective March 27, 2015 as Known to the State of California to Cause Cancer: Beta-Myrcene

Effective March 27, 2015,the Office of Environmental Health Hazard Assessment (OEHHA) is adding beta-myrcene(CAS No. 123-35-3)to the list of chemicals known to the state to cause cancer for purposes of Proposition 65

NTP Information Cited
National Toxicology Program (NTP). 2010. NTP Technical Report on the Toxicology and Carcinogenesis Studies of beta-Myrcene (CASRN 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 557. https://ntp.niehs.nih.gov/go/tr557abs

  • Type: Notice
  • March 24, 2015
  • Proposition 65
123-35-3
2015 OEHHA
Notice of Intent to List: Styrene

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list styrene as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

NTP Information Cited
NTP (National Toxicology Program). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • February 27, 2015
  • Proposition 65
100-42-5
2015 EPA
Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule

Under the Toxic Substance Control Act (TSCA), EPA is proposing significant new use rule (SNUR) for 2,4- toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply." "Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs."

NTP Information Cited
NTP (National Toxicology Program). 2011. Toluene Diisocyanates. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/toluenediisocyanates.pdf

  • Type: Proposed Rule
  • January 15, 2015
  • 80 FR 2068
9019-85-6
9017-01-0
26747-90-0
26603-40-7
26603-40-7 91-08-7
584-84-9
26471-62-5
2015 OEHHA
Notice of Proposed Rulemaking and Announcement of Public Hearing Title 27, California Code of Regulations Proposed Adoption of Section 25205 Proposition 65 Lead Agency Website

This regulation would establish the framework for a website operated by OEHHA that would provide supplemental information to the public about potential exposures to Proposition 65 listed chemicals.

NTP Information Cited
NTP (National Toxicology Program). 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • January 12, 2015
  • Proposition 65
N/A
2014 ATSDR
Prohibition of Children’s Toys and Child Care Articles Containing Specific Phthalates

Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission or CPSC) to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives other than those already permanently prohibited should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. The Commission is proposing this rule pursuant to section 108(b) of the CPSIA. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 104(i)(3),[42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare Toxicological Profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

NTP Information Cited

NTP, 1982. Carcinogenesis bioassay of di(2-ethylhexyl) adipate (CAS No. 103-23-1) in F344 rats and B6C3F1 mice (feed study). National Toxicology Program (NTP), Research Triangle Park, NC. NTP technical report series No. 212. https://ntp.niehs.nih.gov/go/tr212.

NTP, 1989. Developmental Toxicity of Dimethyl Phthalate (CAS No. 131-11-3) Administered to CD Rats on Gestational Days 6 Through 15. National Toxicology Program. NTP Study: TER88066. January 9, 1989. https://ntp.niehs.nih.gov/go/ter88066abs.

NTP, 1997. Reproductive assessment by continuous breeding: Evolving study design and summaries of ninety studies. Environmental Health Perspectives 105 (Suppl 1), 199–395. https://ehp.niehs.nih.gov/doi/pdf/10.1289/ehp.97105s1199.

NTP, 2000. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dbp/dbp_monograph_final.pdf.

NTP, 2002. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf.

NTP, 2003a. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4487. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/bb-phthalate/bbp_monograph_final.pdf.

NTP, 2003b. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-Isodecyl Phthalate (DIDP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. April 2003. NIH publication no. 03-4485. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf.

NTP, 2003c. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4484. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dinp/dinp_monograph_final.pdf.

NTP, 2003d. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4489. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnhp/dnhp_monograph_final.pdf.

NTP, 2006. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. November 2006. NIH publication no. 06-4476. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf.

NTP, 2000. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dbp/dbp_monograph_final.pdf.

NTP, 2003a. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4487. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/bb-phthalate/bbp_monograph_final.pdf.

NTP, 2003c. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4484. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf.

NTP, 2003d. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. March 2003. NIH publication no. 03-4489. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnhp/dnhp_monograph_final.pdf.

NTP, 2003e. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Octyl Phthalate (DnOP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. NIH publication no. 03-4488. May 2003. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnop/dnop_monograph_final.pdf.

NTP, 2004. Diethylhexylphthalate: Multigenerational reproductive assessment by continuous breeding when Diethylhexylphthalate (CAS 117-81-7) was administered to SpragueDawley rats in the diet. National Toxicology Program (NTP), Research Triangle Park, NC. NTP Study no. RACB98004. https://ntp.niehs.nih.gov/publications/abstracts/repro/racb98004/index.html.

NTP, 2006. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. November 2006. NIH publication no. 06-4476. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf.

NTP, 2003b. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-Isodecyl Phthalate (DIDP). Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Research Triangle Park, NC. April 2003. NIH publication no. 03-4485. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf.

  • Type: Notice
  • December 30, 2014
  • 79 FR 78324
2014 OEHHA
OEHHA Presentation on a PBPK Model of Blood Lead and Worker Exposure

The Office of Environmental Health Hazard Assessment (OEHHA) has developed a PBPK (physiologically based pharmacokinetic) model describing the relationship between airborne lead and blood levels in workers and released it in October 2013. The model was developed at the request of the California Department of Public Health (CDPH) and is being used to understand workplace exposures.

NTP Information Cited

NTP (2011) ‘Lead and lead compounds Report on Carcinogens’, Twelfth Edition, National Toxicology program, department of health and human services https://ntp.niehs.nih.gov/go/roc12.

  • Type: Proposition 65
  • December 10, 2014
7439-92-1
2014 EPA
National Emissions Standards for Hazardous Air Pollutants: Primary Aluminum Reduction Plants

This action supplements our proposed amendments to the national emission standards for hazardous air pollutants (NESHAP) for the Primary Aluminum Production source category published in the Federal Register on December 6, 2011. In that action, the Environmental Protection Agency (EPA) proposed amendments based on the initial residual risk and technology reviews (RTR) for this source category, and also proposed certain emission limits reflecting performance of Maximum Achievable Control Technology (MACT). Today’s action reflects a revised technology review and a revised residual risk analysis for the Primary Aluminum Production source category and proposes new and revised emission standards based on those analyses, newly obtained emissions test data, and comments we received in response to the 2011 proposal, including certain revisions to the technology-based standards reflecting performance of MACT. This action also proposes new compliance requirements to meet the revised standards. This action, if adopted, will provide improved environmental protection regarding potential emissions of hazardous air pollutant (HAP) emissions from primary aluminum production facilities.

NTP Information Cited
National Toxicology Program (NTP), 2011. Report on Carcinogens. 12th ed. Research Triangle Park, NC: US Department of Health and Human Services (DHHS), Public Health Service. Available online at https://ntp.niehs.nih.gov/ntp/roc/twelfth/roc12.pdf.

  • Type: Supplemental Proposed Rulemaking
  • December 08, 2014
  • 79 FR 72922
2014 FDA
Information Collection; Qualified Products Lists for Fire Chemicals for Wild Land Fire Management

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension with no revision of a currently approved information collection, Qualified Products Lists for Fire Chemicals for Wild Land Fire Management.

NTP Information Cited

NTP (National Toxicology Program). Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc.

  • Type: Notice
  • November 14, 2014
  • 79 FR 68210
2014 OEHHA
Request for Relevant Information on the Carcinogenic Hazards of Diaminotoluenes

In order to clarify the scope of the listing, OEHHA is referring diaminotoluene (mixed) to the CIC for a determination as to whether the chemical should continue to be included on the list of chemicals known to the state to cause cancer pursuant to Title 27, Cal. Code of Regs., section 25306 (j).

NTP Information Cited

National Toxicology Program, NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures in B6C3F1 Mice, NTP TR 349, NIH Publication No. 89-2804,  March, 1989. https://ntp.niehs.nih.gov/go/tr349.

  • Type: Proposition 65
  • October 23, 2014
2687-25-4
95-70-5
823-40-5
496-72-0
108-71-4
2014 EPA
National Emission Standards for Hazardous Air Pollutants: Ferroalloys Production

This action supplements our proposed amendments to the national emission standards for hazardous air pollutants (NESHAP) for the Ferroalloys Production source category published in the Federal Register on November 23, 2011. In that action, the Environmental Protection Agency (EPA) proposed amendments based on the initial technology and residual risk reviews for this source category. Today’s action presents a revised technology review and a revised residual risk review for the Ferroalloys Production source category and proposes revisions to the standards based on those reviews. This action also proposes new compliance requirements to meet the revised standards. This action would result in significant environmental improvements through the reduction of fugitive manganese emissions and through more stringent emission limits for several processes.

NTP Information Cited

NTP (National Toxicology Program). Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc.

  • Type: Proposed Rule
  • October 20, 2014
  • 79 FR 60238
2014 OSHA
Chemical Management and Permissible Exposure Limits (PELs); Proposed Rule

OSHA is reviewing its overall approach to managing chemical exposures in the workplace and seeks stakeholder input about more effective and efficient approaches that addresses challenges found with the current regulatory approach. This review involves considering issues related to updating permissible exposure limits (PELs), as well as examining other strategies that could be implemented to address workplace conditions where workers are exposed to chemicals. The notice details the role of past court decisions on the Agency’s current approach to chemical management for the purpose of informing stakeholders of the legal framework in which the Agency must operate. It then describes possible modifications of existing processes, along with potential new sources of data and alternative approaches the Agency may consider. The Agency is particularly interested in information about how it may take advantage of newer approaches, given its legal requirements. This RFI is concerned primarily with chemicals that cause adverse health effects from long-term occupational exposure, and is not related to activities being conducted under Executive Order 13650, Improving Chemical Facility Safety and Security.

NTP Information Cited

National Toxicology Program (NTP). (2013). High Throughput Screening Initiative. Retrieved from: https://ntp.niehs.nih.gov/go/28213.

  • Type: Request for Information
  • October 10, 2014
  • 79 FR 61384
2014 FDA
Revocation of General Safety Test Regulations that are Duplicative of Requirements in Biological License Applications

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.

NTP Information Cited
Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 (42 U.S.C. 2851–3). https://ntp.niehs.nih.gov/iccvam/docs/about_docs/pl106545.pdf.

  • Type: Proposed Rule
  • August 22, 2014
  • 79 FR 49729
2014 EPA
Fragrance Components; Proposed Exemption from the Requirement of a Tolerance

This document proposes to establishes an exemption from the requirement of a tolerance for residues of various fragrance component substances (when used as inert ingredients) in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils

NTP Information Cited
NTP. Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://cebs.niehs.nih.gov/cebs.

NTP. Publications. Research Triangle Park, NC (USA): National Toxicology Program (NTP). https://ntp.niehs.nih.gov/go/pubs.

  • Type: Proposed Rule
  • July 25, 2014
  • 79 FR 43350
75-07-0
64-19-7
107-92-6
71-36-3
5392-40-5106-22-9
150-84-5
23726-92-3
112-31-2
65405-70-1
334-48-5
112-30-1
106-72-9
20407-84-5
452-79-1
106-24-1
105-87-3
111-71-7
111-14-8
111-70-6
66-25-1
142-62-1
111-27-3
828-96-1
3681-71-8
142.92-7
111-27-3
143-07-7
112-54-9 112-53-8
5989-27-5
127-42-4
1191-16-8
110-41-8
124-25-4
544-63-8
141-12-8
124-19-6
112-05-0
143-08-8
124-13-0
124-07-2
111-87-5
57-10-3
79-09-4
57-11-4
7774-82-5
5435-64-3
112-44-7
112-42-5
110-62-3
109-52-4
2014 OEHHA
Comments Received on the Notice of Intent to List for Ethylene Glycol

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical ethylene glycol (EG) as known to the state to cause reproductive toxicity (developmental endpoint) under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being proposed under the authoritative bodies listing mechanism

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04 – 4481. https://ntp.niehs.nih.gov/ntp/ohat/egpg/ethylene/eg_monograph.pdf.
.

  • Type: Proposition 65
  • July 01, 2014
107-21-1
2014 OEHHA
Notice of Adoption of Reference Exposure Levels for Benzene

The Office of Environmental Health Hazard Assessment (OEHHA) is adopting new and revised Reference Exposure Levels (RELs) for benzene.

NTP Information Cited

National Toxicology Program (NTP). 1986. NTP technical report on the toxicology and carcinogenesis studies of benzene (CASRN 71-43-2) in F344/N rats and B6C3F1 mice (gavage studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 289. https://ntp.niehs.nih.gov/go/tr289.

  • Type: Proposition 65
  • June 27, 2014
71-43-2
2014 OEHHA
Chemical Listed Effective May 2, 2014 as Known to the State of California to Cause Cancer: N,N-dimethyl-p-toluidine

Effective May 2, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) is adding N,N-dimethyl-p-toluidine to the list of chemicals known to the State to cause cancer for purposes of Proposition 65.

NTP Information Cited
NTP (2012). National Toxicology Program. Toxicology and Carcinogenesis Studies of N,N-Dimethyl-p-Toluidine (CAS No. 99-97-8) in F344/N Rats and B6C3F1/N Mice (Gavage Studies). Technical Report Series No. 579. NIH Publication No. 12-5921. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/tr579.

  • Type: Proposition 65
  • May 02, 2014
99-97-8
2014 EPA
Control of Air Pollution from Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards

This action establishes more stringent vehicle emissions standards and will reduce the sulfur content of gasoline beginning in 2017, as part of a systems approach to addressing the impacts of motor vehicles and fuels on air quality and public health. The gasoline sulfur standard will make emission control systems more effective for both existing and new vehicles, and will enable more stringent vehicle emissions standards. The vehicle standards will reduce both tailpipe and evaporative emissions from passenger cars, light-duty trucks, medium-duty passenger vehicles, and some heavy-duty vehicles. This will result in significant reductions in pollutants such as ozone, particulate matter, and air toxics across the country and help state and local agencies in their efforts to attain and maintain health-based National Ambient Air Quality Standards. Motor vehicles are an important source of exposure to air pollution both regionally and near roads. These vehicle standards are intended to harmonize with California's Low Emission Vehicle program, thus creating a federal vehicle emissions program that will allow automakers to sell the same vehicles in all 50 states. The vehicle standards will be implemented over the same timeframe as the greenhouse gas/fuel efficiency standards for light-duty vehicles (promulgated by EPA and the National Highway Safety Administration in 2012), as part of a comprehensive approach toward regulating emissions from motor vehicles.

NTP Information Cited

NTP (National Toxicology Program). Benzene. Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf.

NTP (National Toxicology Program). 1,3-butadiene. Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/butadiene.pdf.

NTP (National Toxicology Program). Formaldehyde. Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/formaldehyde.pdf.

NTP (National Toxicology Program). Acetaldehyde. Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acetaldehyde.pdf.

NTP (National Toxicology Program). Naphthalene. Report on Carcinogens, Twelfth Edition.; Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/naphthalene.pdf.

  • Type: Final Rule
  • April 28, 2014
  • 79 FR 23414
71-43-2
106-99-0
75-07-0
91-20-3
50-00-0
2014 OEHHA
Intent to List: Ethylene Glycol

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical ethylene glycol (EG) as known to the state to cause reproductive toxicity (developmental endpoint) under the Safe Drinking Water and Toxic Enforcement Act of 1986.1 This action is being proposed under the authoritative bodies listing mechanism.

NTP Information Cited
NTP-CERHR (2004). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Ethylene Glycol. Research Triangle Park, NC, National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction: NIH Publication No. 04-4481. https://ntp.niehs.nih.gov/ntp/ohat/egpg/ethylene/eg_monograph.pdf.

  • Type: Proposition 65
  • April 11, 2014
107–21–1
2014 EPA
Diflubenzuron; Pesticide Tolerances

This regulation establishes tolerances for residues of diflubenzuron (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzimide) in or on fruit, citrus, group 10-10 and citrus, oil. Chemtura Corporation, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NTP Information Cited

National Toxicology Program (NTP). 1989. NTP technical report on the toxicology and carcinogenesis studies of para-chloroaniline hydrochloride in F344/N rats and B6C3F1 mice (gavage studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 351. https://ntp.niehs.nih.gov/go/tr351.

  • Type: Final Rule
  • January 31, 2014
  • 79 FR 5294
20265-96-7
2013 FDA
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record.

The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being safe for antiseptic handwash use by consumers based on safety data evaluated by FDA as part of our ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic wash active ingredients have data that demonstrate a clinical benefit from the use of these consumer antiseptic wash products compared to nonantibacterial soap and water.

NTP Information Cited
National Toxicology Program (NTP). 1988. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol (CASRN 136-77-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 330. https://ntp.niehs.nih.gov/go/tr330abs

  • Type: Proposed
  • December 17, 2013
  • 78 FR 76444
136-77-6
2013 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Acacia (Gum Arabic)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods. This action is in response to a petition filed by Nexira.

NTP Information Cited
National Toxicology Program (NTP). 1982. NTP Technical Report on the Carcinogenesis Bioassay of Gum Arabic (CASRN 9000-01-5) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 227. https://ntp.niehs.nih.gov/go/tr227abs

  • Type: Final Rule
  • December 06, 2013
  • 78 FR 73434
2013 EPA
Addition of ortho-Nitrotoluene; Community Right-to-Know Toxic Chemical Release Reporting

EPA is adding ortho-nitrotoluene (o-nitrotoluene) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. o-Nitrotoluene has been classified by the National Toxicology Program in its 12th Report on Carcinogens as “reasonably anticipated to be a human carcinogen.” EPA has determined that o-nitrotoluene meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans.

NTP Information Cited
NTP (National Toxicology Program). 2011. Ortho-nitrotoluene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitrotoluene.pdf

  • Type: Final Rule
  • November 07, 2013
  • 78 FR 66848
88-72-2
2013 CDC
World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions.

On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. In this final rule, the Administrator adds malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.

NTP Information Cited
NTP (National Toxicology Program). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • September 19, 2013
  • 78 FR 57505
NA
2013 OSHA
Occupational Exposure to Respirable Crystalline Silica

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing standards for occupational exposure to respirable crystalline silica. The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary of Labor for Occupational Safety and Health that employees exposed to respirable crystalline silica face a significant risk to their health at the current permissible exposure limits and that promulgating these proposed standards will substantially reduce that risk. This document proposes a new permissible exposure limit, calculated as an 8-hour time-weighted average, of 50 micrograms of respirable crystalline silica per cubic meter of air (50 μg/m3). OSHA also proposes other ancillary provisions for employee protection such as preferred methods for controlling exposure, respiratory protection, medical surveillance, hazard communication, and recordkeeping. OSHA is proposing two separate regulatory texts—one for general industry and maritime, and the other for construction—in order to tailor requirements to the circumstances found in these sectors.

NTP Information Cited
NTP (National Toxicology Program). 2011. Silica Crystalline (Respirable Size). Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/silica.pdf

  • Type: Proposed
  • September 12, 2013
  • 78 FR 56274
None assigned
2013 CDC
World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions

On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. The Administrator has determined to publish a proposed rule adding malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.

NTP Information Cited

NTP (National Toxicology Program). 2011. Arsenic and Inorganic Arsenic Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/arsenic.pdf

NTP (National Toxicology Program). 2011. Arsenic. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/cadmium.pdf

  • Type: Proposed
  • July 02, 2013
  • 78 FR 39670
7440-38-2
7440-43-9
2013 EPA
Formaldehyde Emissions Standards for Composite Wood Products

EPA is proposing new requirements under the Formaldehyde Standards for Composite Wood Products Act, or Title VI of the Toxic Substances Control Act (TSCA). These proposed requirements are designed to implement the statutory formaldehyde emission standards for hardwood plywood, medium-density fiberboard, and particle board sold, supplied, offered for sale, or manufactured (including imported) in the United States. As directed by the statute, this proposal includes provisions relating to, among other things, laminated products, products made with no-added formaldehyde resins or ultra low-emitting formaldehyde resins, testing requirements, product labeling, chain of custody documentation and other recordkeeping requirements, enforcement, and product inventory sell-through provisions, including a product stockpiling prohibition. The composite wood product formaldehyde emission standards contained in TSCA Title VI are identical to the emission standards currently in place in California. This regulatory proposal implements these emissions standards and is designed to ensure compliance with the TSCA Title VI formaldehyde emission standards while aligning, where practical, with the regulatory requirements in California.

NTP Information Cited

NTP (National Toxicology Program). 2011. Formaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/formaldehyde.pdf

  • Type: Proposed
  • June 10, 2013
  • 78 FR 34820
50-00-0
2013 EPA
Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products

The Formaldehyde Standards for Composite Wood Products Act (Title VI of the Toxic Substances Control Act (TSCA)) establishes formaldehyde emission standards for hardwood plywood, particle board, and medium-density fiberboard (composite wood products) and directs EPA to promulgate implementing regulations by January 1, 2013. Pursuant to the requirements of TSCA Title VI, EPA is proposing a framework for a TSCA Title VI Third-Party Certification Program for composite wood products. Under the framework, third-party certifiers (TPCs) would be accredited by EPA-recognized accreditation bodies (ABs) so that TPCs may certify composite wood product panel producers under TSCA Title VI. This proposed rule identifies the roles and responsibilities of the TPCs and ABs involved, as well as the criteria for participation in the TSCA Title VI Third-Party Certification Program. The Agency is proposing the TSCA Title VI Third-Party Certification Program framework prior to the rest of the TSCA Title VI implementing regulations in order to allow interested parties an opportunity to comment and to begin identifying the business practices and infrastructure that may need to be modified or developed in order to effectively participate in the program.

NTP Information Cited
NTP (National Toxicology Program). 2011. Formaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/formaldehyde.pdf

  • Type: Proposed
  • June 10, 2013
  • 78 FR 34796
50-00-0
2013 EPA
Guar Hydroxy­propyl­tri­methyl­ammonium Chloride; Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of guar hydroxy­propyl­tri­methyl­ammonium chloride (CAS Reg. No. 71329-50-5) when used as an inert ingredient (thickener/drift reduction agent) in pesticide formulations applied to growing crops. SciReg. Inc., on behalf of Rhodia Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of guar hydroxypropyltrimethylammonium chloride.

NTP Information Cited
National Toxicology Program (NTP). 1982. NTP Technical Report on the Carcinogenesis Bioassay of Guar Gum (CASRN  9000-30-0) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 229. https://ntp.niehs.nih.gov/go/tr229abs

  • Type: Proposed
  • May 29, 2013
  • 78 FR 12782
9000-30-0
2013 EPA
Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards

This action would establish more stringent vehicle emissions standards and reduce the sulfur content of gasoline beginning in 2017, as part of a systems approach to addressing the impacts of motor vehicles and fuels on air quality and public health. The proposed gasoline sulfur standard would make emission control systems more effective for both existing and new vehicles, and would enable more stringent vehicle emissions standards. The proposed vehicle standards would reduce both tailpipe and evaporative emissions from passenger cars, light-duty trucks, medium-duty passenger vehicles, and some heavy-duty vehicles. This would result in significant reductions in pollutants such as ozone, particulate matter, and air toxics across the country and help state and local agencies in their efforts to attain and maintain health-based National Ambient Air Quality Standards. Motor vehicles are an important source of exposure to air pollution both regionally and near roads. These proposed vehicle standards are intended to harmonize with California's Low Emission Vehicle program, thus creating a federal vehicle emissions program that would allow automakers to sell the same vehicles in all 50 states. The proposed vehicle standards would be implemented over the same timeframe as the greenhouse gas/fuel efficiency standards for light-duty vehicles, as part of a comprehensive approach toward regulating emissions from motor vehicles.

NTP Information Cited
NTP (National Toxicology Program). 2011. Acetaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acetaldehyde.pdf

NTP (National Toxicology Program). 2011. Naphthalene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/naphthalene.pdf

NTP (National Toxicology Program). 2011. Benzene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf             

NTP (National Toxicology Program). 2011. 1,3-Butadiene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/butadiene.pdf

NTP (National Toxicology Program). 2011. Formaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/formaldehyde.pdf

  • Type: Proposed
  • May 21, 2013
  • 78 FR 8500
50-00-0
71-43-2
75-07-0
91-20-3
106-99-0
2013 OEHHA
Chemical Delisted Effective April 19, 2013 as Known to the State of California to Cause Reproductive Toxicity: Bisphenol A (BPA)

Effective April 19, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) is removing bisphenol A (BPA) (CAS No. 80-05-7) from the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of Proposition 65.1 The chemical was added to the list on April 11, 2013 based on reproductive endpoints (developmental toxicity).

NTP Information Cited

National Toxicology Program (NTP). 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf

NTP (1985) Bisphenol A: Reproduction and Fertility Assessment in CD-1 Mice when Administered in the Feed. NTP-85-192. Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/racb84080abs

  • Type: Notice
  • April 19, 2013
  • Proposition 65
80-05-7
2013 CDC
World Trade Center Health Program; Certification of Breast Cancer in WTC Responders and Survivors Exposed to PCBs

On September 12, 2012, HHS published a final rule in the Federal Register adding certain types of cancer to the List of World Trade Center (WTC)-Related Health Conditions (List) established in the WTC Health Program regulation. Breast cancer was included on the List, although only individuals experiencing nighttime sleep disruption as a result of response and cleanup activities involving shiftwork are currently considered to have experienced exposure relevant for certification. A recent publication in The Lancet Oncology by the International Agency for Research on Cancer (IARC) concludes that there is limited evidence that polychlorinated biphenyls (PCBs) cause breast cancer in humans. As described below, the WTC Program Administrator (Administrator) has found that PCBs were present in WTC dust in the New York City disaster area and, accordingly, the Program will now certify breast cancer in eligible WTC responders and survivors who were exposed to either shiftwork/nighttime sleep disruption or PCBs as a result of the 9/11 attacks.

NTP Information Cited
NTP (National Toxicology Program). 2011. Polychlorinated Biphenyls. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/polychlorinatedbiphenyls.pdf

  • Type: Final Rule
  • April 17, 2013
  • 78 FR 22794
1336-36-3
2013 EPA
Addition of ortho-Nitrotoluene; Community Right-to-Know Toxic Chemical Release Reporting

EPA is proposing to add ortho-nitrotoluene (o-nitrotoluene) to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. o-Nitrotoluene has been classified by the National Toxicology Program in their 12th Report on Carcinogens as “reasonably anticipated to be a human carcinogen.” EPA believes that o-nitrotoluene meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, o-nitrotoluene is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

NTP Information Cited
NTP (National Toxicology Program). 2011. o-Nitrotoluene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitrotoluene.pdf

  • Type: Proposed
  • March 13, 2013
  • 78 FR 15913
88-72-2
2012 EPA
2017 and Later Model Year Light-Duty Vehicle Greenhouse Gas Emissions and Corporate Average Fuel Economy Standards

EPA and NHTSA, on behalf of the Department of Transportation, are issuing final rules to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017 and beyond. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to improve fuel economy and reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025, building on the success of the first phase of the National Program for these vehicles for model years 2012-2016. This final rule, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is finalizing Corporate Average Fuel Economy standards for model years 2017-2021 and issuing augural standards for model years 2022-2025 under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act. NHTSA will set final standards for model years 2022-2025 in a future rulemaking. EPA is finalizing greenhouse gas emissions standards for model years 2017-2025 under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent the continuation of a harmonized and consistent National Program. Under the National Program automobile manufacturers will be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices that are available today. EPA is also finalizing minor changes to the regulations applicable to model years 2012-2016, with respect to air conditioner performance, nitrous oxides measurement, off-cycle technology credits, and police and emergency vehicles.

NTP Information Cited

National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • October 15, 2012
  • 77 FR 62624
75-07-0
91-20-3
71-43-2
106-99-0
50-00-0
2012 CDC
World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with WTC Health Program regulations, which establish procedures for adding a new condition to the list of covered health conditions, this final rule adds to the List of WTC-Related Health Conditions the types of cancer proposed for inclusion by the notice of proposed rulemaking.

NTP Information Cited
National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • September 12, 2012
  • 77 FR 567138
NA
2012 OEHHA
Added to List of Chemicals Known to the State to Cause Cancer: Isopyrazam and 3,3',4,4'-Tetrachloroazobenzene

Effective July 24, 2012, the Office of Environmental Health Hazard Assessment (OEHHA) is adding two chemicals, isopyrazam (CAS No. 881685-58-1) and 3,3’,4,4’‑tetrachloroazobenzene (CAS No. 14047-09-7), to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 651)

NTP Information Cited

National Toxicology Program (NTP). 1998. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 3,3',4,4'-Tetrachloroazobenzene (CASRN 14047-09-7) to F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 65.
https://ntp.niehs.nih.gov/go/tox65abs

  • Type: Notice
  • July 24, 2012
  • Proposition 65
14047-09-7
2012 CPSC
Proposed Statement of Policy on Animal Testing

The Consumer Product Safety Commission (CPSC or Commission) proposes to codify its statement of policy on animal testing, as amended, which was previously published in the Federal Register. The amended statement of policy on animal testing is intended for manufacturers of products subject to the Federal Hazardous Substances Act (FHSA) to find alternatives to animal testing and reduce the number of animal tests under the FHSA.

NTP Information Cited

ICCVAM Authorization Act of 2000
https://ntp.niehs.nih.gov/iccvam/docs/about_docs/pl106545.pdf

  • Type: Proposed
  • June 29, 2012
  • 77 FR 38751
NA
2012 CDC
World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with our regulations, which establish procedures for adding a new condition to the list of health conditions covered by the WTC Health Program, this proposed rule would add certain types of cancer to the List of WTC-Related Health Conditions.

NTP Information Cited

National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • June 13, 2012
  • 77 FR 35574
7740-38-2
75-01-4
2012 EPA
Sixty-Ninth Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 69th Report to the EPA Administrator on April 5, 2012. In the 69th ITC Report, which is included with this notice, the ITC is adding a category of cadmium compounds including any chemical that contains cadmium as part of that chemical's structure, 6 non-phthalate plasticizers, 25 phosphate ester flame retardants, 2 other flame retardants, 9 chemicals to which children living near hazardous waste sites may be exposed, and a category of 69 diisocyanates and related compounds (including 14 Action Plan chemicals and 55 related compounds) to the TSCA Priority Testing List. In addition, the ITC is removing 103 cadmium compounds and 14 High Production Volume (HPV) Challenge Program orphan chemicals from the Priority Testing List during this reporting period (June to November 2011). The ITC is adding the category of cadmium compounds and removing 103 cadmium compounds to provide a more comprehensive approach to assessing cadmium compounds' safety.

NTP Information Cited

National Toxicology Program (NTP). 2012. Tris(1,3-Dichloro-2-propyl) Phosphate (13674-87-8). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC: National Toxicology Program.
https://cebs.niehs.nih.gov/cebs/test_article/13674-87-8

  • Type: Notice
  • May 23, 2012
  • 77 FR 30856
13674-84-5
2012 EPA
Integrated Risk Information System (IRIS); Announcement of 2012 Program

The U.S. Environmental Protection Agency (EPA) is announcing the IRIS 2012 agenda and requesting scientific information on health effects that may result from exposure to the chemical substances on the agenda, including assessments that EPA is starting this year.

NTP Information Cited

National Toxicology Program (NTP). 2012. NTP Monograph on Health Effects of Low-Level Lead. Research Triangle Park, NC: National Toxicology Program.
https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf

  • Type: Other
  • May 07, 2012
  • 77 FR 26751
7439-92-1
2012 FDA
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List

The Food and Drug Administration (FDA) is establishing a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

NTP Information Cited

National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • April 03, 2012
  • 77 FR 20034
N/A
2012 EPA
Benzidine-Based Chemical Substances; Di-n-pentyl phthalate (DnPP); and Alkanes, C12–13, Chloro; Proposed Significant New Use Rules

Under the Toxic Substances Control Act (TSCA), EPA is proposing: To add nine benzidine-based chemical substances to the Significant New Use Rule (SNUR) on benzidine-based chemical substances; a SNUR for di-n-pentyl phthalate (DnPP) (1,2-benzene­di­carboxylic acid, 1,2-dipentyl ester) (CAS No. 131-18-0); and a SNUR for alkanes, C12–13, chloro (CAS No. 71011-12-6). In the case of the benzidine-based chemical substances, EPA is also proposing to make inapplicable the exemption relating to persons that import or process substances as part of an article. If finalized, this rule would require persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance.

NTP Information Cited

National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/ntp/ohat/phthalates/bb-phthalate/bbp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Octyl Phthalate (DnOP). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnop/dnop_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dinp/dinp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-Isodecyl Phthalate (DIDP). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the  Potential Human Reproductive and Developmental Effects of Di(2-Ethylhexyl) Phthalate (DEHP). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf

National Toxicology Program (NTP). 2003. Testing Status of Di-n-pentylphthalate (131-18-0). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/ts-131180

  • Type: Proposed
  • March 28, 2012
  • 77 FR 18752
92-87-5
131-18-0
2012 OSHA
Hazard Communication

In this final rule, OSHA is modifying its Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has determined that the modifications will significantly reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the requirements of Executive Order 13563, which calls for assessment and, where appropriate, modification and improvement of existing rules, the Agency has concluded this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. The modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets. OSHA is also modifying provisions of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. The consequences of these modifications will be to improve safety, to facilitate global harmonization of standards, and to produce hundreds of millions of dollars in annual savings.

NTP Information Cited
National Toxicology Program (NTP). 2012. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • March 26, 2012
  • 77 FR 17574
NA
2012 FDA
International Conference on Harmonisation; Final Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

NTP Information Cited

National Toxicology Program (NTP). 1996. Toxicology and Carcinogenesis Studies of 2,2-Bis(Bromomethyl)-1,3-Propanediol (FR-1138) (CASRN  3296-90-0) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-452.
https://ntp.niehs.nih.gov/go/tr452abs

  • Type: Notice
  • February 23, 2012
  • 77 FR10754
98-82-8
2012 EPA
National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units

On May 3, 2011, under authority of Clean Air Act (CAA) sections 111 and 112, the EPA proposed both national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) and standards of performance for fossil-fuel-fired electric utility, industrial-commercial-institutional, and small industrial-commercial-institutional steam generating units (76 FR 24976). After consideration of public comments, the EPA is finalizing these rules in this action.

NTP Information Cited

National Toxicology Program (NTP). 1996. Toxicology and Carcinogenesis Studies of Nickel Subsulfide (CASRN 12035-72-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-453.
https://ntp.niehs.nih.gov/go/tr453abs

National Toxicology Program (NTP). 1996. Toxicology and Carcinogenesis Studies of Nickel Sulfate Hexahydrate (CASRN 10101-97-0) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-454.
https://ntp.niehs.nih.gov/go/tr454abs

  • Type: Final Rule
  • February 16, 2012
  • 77 FR 9304
10101-97-0
12035-72-2
2011 DEA
Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance carisoprodol, including its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing.

NTP Information Cited
National Toxicology Program (NTP). 2000. Toxicity Studies of Carisoprodol (CASRN 78-44-4) Administered to F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TOX-56.
https://ntp.niehs.nih.gov/go/tox56abs

  • Type: Final Rule
  • December 12, 2011
  • 76 FR 77330
78-44-4
2011 DOT
2017 and Later Model Year Light-Duty Vehicle Greenhouse Gas Emissions and Corporate Average Fuel Economy Standards

EPA and NHTSA, on behalf of the Department of Transportation, are issuing this joint proposal to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017-2025. This proposal extends the National Program beyond the greenhouse gas and corporate average fuel economy standards set for model years 2012-2016. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025. This proposal, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act, and EPA is proposing greenhouse gas emissions standards under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent a continued harmonized and consistent National Program. Under the National Program for model years 2017-2025, automobile manufacturers would be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices. EPA is also proposing a minor change to the regulations applicable to MY 2012-2016, with respect to air conditioner performance and measurement of nitrous oxides.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • December 01, 2011
  • 76 FR 74854
71-43-2
106-99-0
75-07-0
91-20-3
2011 EPA
National Emissions Standards for Hazardous Air Pollutants: Ferroalloys Production

The EPA is proposing amendments to the national emissions standards for hazardous air pollutants for Ferroalloys Production to address the results of the residual risk and technology review that the EPA is required to conduct under the Clean Air Act. These proposed amendments include revisions to particulate matter standards for electric arc furnaces, metal oxygen refining processes, and crushing and screening operations. The amendments also add emission limits for hydrochloric acid, mercury, polycyclic aromatic hydrocarbons, and formaldehyde from electric arc furnaces. Furthermore, the amendments expand and revise the requirements to control fugitive emissions from furnace operations and casting. Other proposed requirements related to testing, monitoring, notification, recordkeeping, and reporting are included. We are also proposing to revise provisions addressing periods of startup, shutdown, and malfunction to ensure that the rules are consistent with a recent court decision.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • November 23, 2011
  • 76 FR 72508
NA
2011 EPA
Testing of Certain High Production Volume Chemicals; Third Group of Chemicals

EPA is promulgating this final rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule. This test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety. Based on comments received by EPA on the proposed rule for this final rule, EPA has determined that only 15 of the 29 HPV chemical substances proposed for testing meet the criteria for testing at this time.

NTP Information Cited
National Toxicology Program (NTP). 2002. Metabolism, Toxicity, and Predicted Carcinogenicity Studies of Diazoaminobenzene (CASRN 136-35-6) Administered Dermally to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TOX-73.
https://ntp.niehs.nih.gov/go/tox73abs

  • Type: Final Rule
  • October 21, 2011
  • 76 FR 65385
NA
2011 EPA
Certain High Production Volume Chemicals; Test Rule and Significant New Use Rule; Fourth Group of Chemicals

EPA is proposing to issue a test rule under Toxic Substances Control Act (TSCA) section 4(a)(1)(B) to require manufacturers and processors of 23 high production volume (HPV) chemical substances to develop screening-level health, environmental, and fate data based on the potential for substantial exposures of workers and consumers to these chemicals. EPA is also proposing to issue simultaneously a significant new use rule (SNUR) for another 22 HPV chemical substances under TSCA section 5(a)(2). The SNUR would require persons to file a significant new use notice (SNUN) with EPA prior to manufacturing, importing, or processing any of these chemical substances for use in a consumer product or for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. EPA is also soliciting comment on a number of issues with regard to both the test rule and the SNUR.

NTP Information Cited

National Toxicology Program (NTP). 2003. Test Method Protocol for the BALB/c 3T3 Neutral Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro Validation Study—Phase III. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/iccvam/methods/acutetox/invidocs/phiiiprot/3t3phiii.pdf

National Toxicology Program (NTP). 2003. Test Method Protocol for the NHK Neutral Red Uptake Cytotoxicity Test, a Test for Basal Cytotoxicity for an in vitro Validation Study—Phase III. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. 
https://ntp.niehs.nih.gov/iccvam/methods/acutetox/invidocs/phiiiprot/nhkphiii.pdf

National Toxicology Program (NTP). 2003. Test Method Protocol for Solubility Determination, in vitro Cytotoxicity Validation Study—Phase III. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/iccvam/methods/acutetox/invidocs/phiiiprot/solphiii.pdf

  • Type: Proposed
  • October 21, 2011
  • 76 FR 65580
NA
2011 USDA
Information Collection; Qualified Products List for Water Enhancers (Gels) for Wildland Firefighting

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Water Enhancers (Gels) for Wildland Firefighting.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • September 21, 2011
  • 76 FR 58462
NA
2011 USDA
Information Collection; Qualified Products List for Long-Term Retardant for Wildland Firefighting

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (with contact revision) of a currently approved information collection, Qualified Products List for Long-Term Retardant For Wildland Firefighting.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • September 21, 2011
  • 76 FR 58460
N/A
2011 DOT , EPA
Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles

EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy-duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • September 15, 2011
  • 76 FR 57106
71-43-2
106-99-0
75-07-0
91-20-3
2011 USDA
Information Collection; Qualified Products List for Class A Foams for Wildland Firefighting

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Class A Foams for Wildland Firefighting.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • September 11, 2011
  • 76 FR 58461
NA
2011 EPA
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Request for Comments

The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • August 12, 2011
  • 76 FR 50226
N/A
2011 OEHHA
OEHHA Adopts First-in-the-Nation Public Health Goal For Hexavalent Chromium in Drinking Water

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) today published the nation’s first public health goal (PHG) for hexavalent chromium in drinking water. Hexavalent Chromium in Drinking Water Fact Sheet. The final PHG for hexavalent chromium, also known as chromium 6, is set at 0.02 parts per billion (ppb), which is the same level as the draft that was released for public comment in December 2010. “This final public health goal is the culmination of years of study and research on the health effects of this chemical,” said Dr. George Alexeeff, OEHHA’s Acting Director. “As the nation’s first official goal for this contaminant, it will be an important tool that the Department of Public Health will use to develop a regulatory standard that will protect Californians from the health risks of chromium 6 in drinking water.”

NTP Information Cited

National Toxicology Program (NTP). 2008. Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Dichromate Dihydrate (CASRN 7789-12-0) in F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-546. https://ntp.niehs.nih.gov/go/tr546abs

  • Type: Notice
  • July 27, 2011
  • Public Health Goals
7789-12-0
2011 EPA
Carboxymethyl Guar Gum Sodium Salt and Carboxy­methyl-Hydroxy­propyl Guar; Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of carboxymethyl guar gum sodium salt (CAS Reg. No. 39346-76-4) and carboxy­methyl-hydroxy­propyl guar (CAS Reg. No. 68130-15-4); when used as an inert ingredient (thicker/drift reduction agent) in pesticide formulations applied to growing crops. SciReg Inc., on behalf of Rhodia Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of carboxymethyl guar gum sodium salt and carboxy­methyl-hydroxy­propyl guar.

NTP Information Cited

National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of Guar Gum (CASRN 9000-30-0) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-229.
https://ntp.niehs.nih.gov/go/tr229abs

  • Type: Final Rule
  • July 27, 2011
  • 76 FR 44811
9000-30-0
2011 EPA
Testing of Bisphenol A

Bisphenol A (BPA) (Chemical Abstracts Service Registry Number (CASRN) 80-05-7), a high production volume (HPV) chemical, is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic. EPA is providing this ANPRM to request comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. EPA is working with the Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time.

NTP Information Cited

National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of Bisphenol A (CASRN 80-05-7) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-215.
https://ntp.niehs.nih.gov/go/tr215abs

  • Type: Notice
  • July 26, 2011
  • 76 FR 44535
80-05-7
2011 DOT
Hazardous Materials: Revision to the List of Hazardous Substances and Reportable Quantities

PHMSA amends the Hazardous Materials Regulations by removing saccharin and its salts from the list of hazardous substances and reportable quantities. The Comprehensive Environmental Response, Compensation and Liability Act, requires PHMSA to list and regulate all hazardous substances designated by statute or by the U.S. Environmental Protection Agency (EPA). EPA recently removed saccharin and its salts from their list of hazardous substances through notice and comment rulemaking. This final rule simply harmonizes the lists to better enable shippers and carriers to identify the affected hazardous substances, comply with all applicable regulatory requirements, and make required notifications if the release of a hazardous substance occurs.

NTP Information Cited
National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • June 27, 2011
  • 76 FR 37283
81-07-2
2011 EPA
Diethylene Glycol MonoEthyl Ether (DEGEE); Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of Diethylene Glycol MonoEthyl Ether (DEGEE) when used as an inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products, for preharvest use on growing crops and raw agricultural commodities, without limitation. Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc., BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of DEGEE on growing crops and raw agricultural commodities.

NTP Information Cited

National Toxicology Program (NTP). 1993. Toxicology and Carcinogenesis Studies of Ethylene Glycol (CASRN 107-21-1) in B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-413.
https://ntp.niehs.nih.gov/go/tr413abs

  • Type: Final Rule
  • June 22, 2011
  • 76 FR 36349
107-21-1
2011 FDA
Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the-counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • June 17, 2011
  • 76 FR 35620
N/A
2011 EPA
Ethylene Glycol; Exemption from the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as a pesticide inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products without limitation. Huntsman, et. al, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol. Also, this regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as an inert ingredient as an encapsulating agent for pesticides being applied post-harvest as residual, and crack and crevice sprays in and around food and nonfood areas of residential and nonresidential structures, including food handling establishments, with no limit. The Sumitomo Chemical Company submitted a petition to EPA under FFDCA, requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol.

NTP Information Cited

National Toxicology Program (NTP). 1978. Bioassay of Nitrofen (1836-75-5) for Possible Carcinogenicity. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/tr026abs

  • Type: Final Rule
  • June 01, 2011
  • 76 FR 31471
109-86-4
110-80-5
111-76-2
2011 DOD
Defense Federal Acquisition Regulation Supplement; Minimizing the Use of Materials Containing Hexavalent Chromium (DFARS Case 2009–D004)

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the requirements for minimizing the use of materials containing hexavalent chromium in items acquired by DoD (deliverables and construction materials hereafter referred to as deliverables). Hexavalent chromium is a chemical that has been used in numerous DoD weapons systems and platforms due to its corrosion protection properties. However, hexavalent chromium is a known carcinogen. This rule codifies a DoD policy for addressing the serious human health and environmental risks related to the use of hexavalent chromium. The rule prohibits the delivery of items containing more than 0.1 percent by weight hexavalent chromium in any homogeneous material under DoD contracts unless there is no acceptable alternative to the use of hexavalent chromium.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • May 05, 2011
  • 76 FR 25569
N/A
2011 OEHHA
Chemicals Listed Effective May 3, 2011 as Known to the State of California to Cause Cancer: Malonaldehyde, Sodium Salt

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 1988). Toxicology and Carcinogenesis Studies of Malonaldehyde, Sodium Salt (3-Hydroxy-2-propenal, Sodium Salt) (CAS No. 24382-04-5) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 331. NIH Publication No. 89-2587, U.S. Department of Health and Human Services, NTP Research Triangle Park, NC.

  • Type: Notice
  • May 03, 2011
  • Proposition 65
24382-04-5
2011 OEHHA
Chemicals Listed Effective May 3, 2011 as Known to the State of California to Cause Cancer: Androstenedione

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Androstenedione (CAS No. 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 560. NIH Publication No. 10-5901. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

  • Type: Notice
  • May 03, 2011
  • Proposition 65
63-05-8
2011 OEHHA
Chemicals Listed Effective May 3, 2011 as Known to the State of California to Cause Cancer: Dibromoacetonitrile

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited

National Toxicology Program (NTP). 1988. Toxicology and Carcinogenesis Studies of Malonaldehyde, Sodium Salt (3-Hydroxy-2-propenal, Sodium Salt) (CASRN 24382-04-5) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-331.
https://ntp.niehs.nih.gov/go/tr331abs

National Toxicology Program (NTP). 2010. Toxicology and Carcinogenesis Studies of Androstenedione (CASRN 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-560.
https://ntp.niehs.nih.gov/go/tr560abs

National Toxicology Program (NTP). 2010. Toxicology and Carcinogenesis Studies of Dibromoacetonitrile (CASRN 3252-43-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-544.
https://ntp.niehs.nih.gov/go/tr544abs

  • Type: Notice
  • May 03, 2011
  • Proposition 65
3252-43-5
2011 EPA
National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units

The United States (U.S.) Environmental Protection Agency (EPA or Agency) is proposing national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) under Clean Air Act (CAA or the Act) section 112(d) and proposing revised new source performance standards (NSPS) for fossil-fuel-fired EGUs under CAA section 111(b). The proposed NESHAP would protect air quality and promote public health by reducing emissions of the hazardous air pollutants (HAP) listed in CAA section 112(b). In addition, these proposed amendments to the NSPS are in response to a voluntary remand of a final rule. We also are proposing several minor amendments, technical clarifications, and corrections to existing NSPS provisions for fossil-fuel-fired EGUs and large and small industrial-commercial-institutional steam generating units.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • May 03, 2011
  • 76 FR 25053
75-07-0
71-43-2
2011 EPA
Sodium Ferric Ethylenediaminetetraacetate; Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of sodium ferric ethylenediaminetetraacetate (EDTA) in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. W. Neudorff GmbH KG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium ferric EDTA under the FFDCA.

NTP Information Cited

National Toxicology Program (NTP). 1977. Bioassay of Trisodium Ethylenediaminetetraacetate Trihydrate (EDTA) (CASRN 150-38-9) for Possible Carcinogenicity. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-011.
https://ntp.niehs.nih.gov/go/tr011abs

  • Type: Final Rule
  • March 30, 2011
  • 76 FR 17556
178949–82–1
2011 OEHHA
Chemical Listed Effective February 25, 2011 as Known to the State of California to Cause Reproductive Toxicity: Acrylamide (CAS No. 79-06-1)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding acrylamide (CAS No. 79-06-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of acrylamide is effective February 25, 2011. Acrylamide is being listed as a chemical known to the State of California to cause developmental and male reproductive toxicity.

NTP Information Cited

National Toxicology Program (NTP). 2011. Report on Carcinogens, Twelfth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • February 25, 2011
  • Proposition 65
79-06-1
2011 EPA
Agency Information Collection Activities; Proposed Collections; Toxic Chemical Release Reporting; Request for Comments on Proposed Renewal of Form R and Form A, Including Minor Form Revisions and the Ratio-Based Burden Methodology

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on July 31, 2011. The ICR Supporting Statement, which is summarized below and also posted in the docket, along with a technical document titled ‘‘Revising TRI Burden to Ratio-Based Methodology,’’ describes the nature of the information collection (including proposed form changes) and its estimated burden and cost. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

NTP Information Cited
On November 26, 2010, the Addition of National Toxicology Program Carcinogens rule was published in the Federal Register.

The addition of National Toxicology Program Carcinogens rule, affects the EPA’s Information ColIection Request (ICR) by increasing the number of reporting facilities by 74 and the number of Form Rs submitted by 186 with an associated burden increase of 6,641 hours.

  • Type: Notice
  • February 11, 2011
  • 76 FR 7841
N/A
2011 EPA
(S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt; Exemption From the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt (CAS Reg. No. 178949–82–1) when used as an inert ingredient (sequestrant or chelating agent) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under EPA regulations. Innospec Limited submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)-ethylenediamine disuccinic acid trisodium salt.

NTP Information Cited

National Toxicology Program (NTP). 1977. Bioassay of Trisodium Ethylenediaminetetraacetate Trihydrate (EDTA) (CASRN 150-38-9) for Possible Carcinogenicity. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-011.
https://ntp.niehs.nih.gov/go/tr011abs

  • Type: Final Rule
  • February 04, 2011
  • 76 FR 6347
178949–82–1
2011 OEHHA
Chemical Listed Effective January 7, 2011 as Known to the State of California to Cause Cancer: 4-Methylimidazole

4-Methylimidazole meets the criteria for listing as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code Section 25249.5 et seq.), more commonly known as Proposition 65, via the authoritative bodies mechanism. The regulatory requirements for listing by this mechanism are set forth in Title

NTP Information Cited

National Toxicology Program (NTP). 2007. Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CASRN 822-36-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-535.
https://ntp.niehs.nih.gov/go/tr535abs

  • Type: Notice
  • January 07, 2011
  • Proposition 65
822-36-6
2010 OEHHA
Announcement of Publication of the Final Public Health Goals for Benzo(A)Pyrene, Methoxychlor, and TCDD (Dioxin) In Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final technical support documents for the Public Health Goals (PHGs) for benzo(a)pyrene, methoxychlor, and TCDD (dioxin) in drinking water. The PHG for benzo(a)pyrene is established at 0.007 parts per billion (ppb), based on carcinogenic effects in rats and mice. The PHG for methoxychlor is established at 0.09 ppb, based on effects in male offspring of female mice treated with methoxychlor during pregnancy. The PHG for TCDD is established at 0.00005 parts per trillion (ppt), based on tumors in multiple sites in female rats.

NTP Information Cited

National Toxicology Program (NTP). 1982. NTP Technical Report on the Carcinogenesis Bioassay of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (CASRN 1746-01-6) in Swiss-Webster Mice. Research Triangle Park, NC: National Toxicology Program. Technical Report 201. https://ntp.niehs.nih.gov/go/tr201abs

National Toxicology Program (NTP). 1982. NTP Technical Report on the Carcinogenesis Bioassay of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (CASRN 1746-01-6) in Osborne-Mendel Rats and B6C3F1 Mice (Gavage Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 209. https://ntp.niehs.nih.gov/go/tr209abs

NTP (National Toxicology Program). (1984). Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation. Board of Scientific Counselors. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC. https://ntp.niehs.nih.gov/ntp/about_ntp/bsc/archives/1984/august/bsc_minutes19840816_508.pdf

NTP (National Toxicology Program). 2000. Report on Carcinogens, Ninth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

National Toxicology Program (NTP). 2006. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) (1746-01-6) in Female Harlan Sprague-Dawley Rats (Gavage Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 521. https://ntp.niehs.nih.gov/go/tr521abs

NTP (National Toxicology Program),  NIEHS (National Institute of Environmental Health Sciences). (1989). Symposium on Significance of Foci of Cellular Alteration in the Rat Liver. Toxicol Pathol 17:557-735. https://pubmed.ncbi.nlm.nih.gov/2629097/

  • Type: Notice
  • September 16, 2010
  • Public Health Goals
2010 EPA
Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Removal of Saccharin and Its Salts From the Lists of Hazardous Constituents, Hazardous Wastes, and Hazardous Substances

The Environmental Protection Agency (EPA or the Agency) is proposing to amend its regulations under the Resource Conservation and Recovery Act (RCRA) to remove saccharin and its salts from the lists of hazardous constituents and commercial chemical products, which are hazardous wastes when discarded or intended to be discarded. EPA is also proposing to amend the regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to remove saccharin and its salts from the list of hazardous substances. This proposed rule is in response to a petition submitted to EPA by the Calorie Control Council (CCC), to remove saccharin and its salts from the above lists. EPA is proposing to grant CCC's petition based on a review of the evaluations conducted by key public health agencies concerning the carcinogenic and other potential toxicological effects of saccharin and its salts, as well as EPA’s own assessment of the waste generation and management information for saccharin and its salts, which demonstrate that saccharin and its salts do not meet the criteria in the hazardous waste regulations for remaining on EPA's lists of hazardous constituents, hazardous wastes, and hazardous substances.

NTP Information Cited

National Toxicology Program (NTP). 1999. NTP Report on Carcinogens Background Document for Saccharin (CASRN 81-07-2). Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/newhomeroc/other_background/saccharin1_3apps_508.pdf

  • Type: Proposed
  • April 22, 2010
  • 75 FR 20942
81-07-2
2010 EPA
Addition of National Toxicology Program (NTP) Carcinogens; Community Right-to-Know Toxic Chemical Release Reporting

EPA is proposing to add sixteen (16) chemicals to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited

NTP (National Toxicology Program). 2005. 1-Amino-2,4-dibromoanthraquinone. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/aminodibromoanthraquinone.pdf

NTP (National Toxicology Program). 2005. 2,2-bis(Bromomethyl)-1,3-propanediol. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bis_bromomethyl_propanediol.pdf

NTP (National Toxicology Program). 2005. Furan. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/furan.pdf

NTP (National Toxicology Program). 2005. Glycidol. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/glycidol.pdf

NTP (National Toxicology Program). 2005. Isoprene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/isoprene.pdf

NTP (National Toxicology Program). 2005. Methyleugenol. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/methyleugenol.pdf

NTP (National Toxicology Program). 2005. 1,6-Dinitropyrene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitroarenes.pdf

NTP (National Toxicology Program). 2005. 1,8-Dinitropyrene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitroarenes.pdf

NTP (National Toxicology Program). 2005. 6-Nitrochrysene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitroarenes.pdf

NTP (National Toxicology Program). 2005. 4-Nitropyrene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitroarenes.pdf

NTP (National Toxicology Program). 2005. o-Nitroanisole. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. ) https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitroanisole.pdf

NTP (National Toxicology Program). 2005. Nitromethane. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. )
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nitromethane.pdf

NTP (National Toxicology Program). 2005. Phenolphthalein. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. )
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/phenolphthalein.pdf

NTP (National Toxicology Program). 2005. Tetrafluoroethylene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. )
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/tetrafluoroethylene.pdf

NTP (National Toxicology Program). 2005. Tetranitromethane. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. )
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/tetranitromethane.pdf

NTP (National Toxicology Program). 2005. Vinyl Fluoride. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. )
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/vinylhalides.pdf

  • Type: Proposed
  • April 06, 2010
  • 75 FR 17333
81-49-2
3296-90-0
110-00-9
556-52-5
78-79-5 93-15-2
42397-64-8
42397-65-9
7496-02-8
57835-92-4
91-23-6
75-52-5
77-09-8
116-14-3
509-14-8
75-02-5
2010 FDA
Food Additives; Bisphenol A; Availability

The Food and Drug Administration (FDA) announces the availability of five documents related to FDA’s continuing assessment of Bisphenol A (BPA) and solicits public comments on the four documents prepared by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.

NTP Information Cited

National Toxicology Program (NTP). 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bisphenol/bisphenol.pdf

  • Type: Notice
  • April 05, 2010
  • 75 FR 17145
80-05-7
2010 OEHHA
Bromochloroacetic Acid (CAS No. 5589-96-8), Cumene (CAS No. 98-82-8) and Diclofop-Methyl (CAS No. 51338-27-3) Listed as Known to the State to Cause Cancer

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding Bromochloroacetic acid (CAS No. 5589-96-8), Cumene (CAS No. 98-82-8) and Diclofop-methyl (CAS No. 51338-27-3) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of bromochloroacetic acid, cumene and diclofop-methyl is effective April 6, 2010.

NTP Information Cited

National Toxicology Program (NTP). 2009. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Cumene (CASRN 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 542. https://ntp.niehs.nih.gov/go/tr542abs

National Toxicology Program (NTP). 2009. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CASRN 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 549. https://ntp.niehs.nih.gov/go/tr549abs

  • Type: Final Rule
  • April 02, 2010
  • Proposition 65
5589-96-8
98-82-8
2010 EPA
Testing of Certain High Production Volume Chemicals; Third Group of Chemicals

EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers, and processors of certain high production volume (HPV) chemicals to conduct testing to obtain screening level data for health and environmental effects and chemical fate.

NTP Information Cited

NTP (National Toxicology Program). 2005. Acetaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acetaldehyde.pdf

NTP (National Toxicology Program). 2005. Benzene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf

NTP (National Toxicology Program). 2005. 1,3-Butadiene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/butadiene.pdf

NTP (National Toxicology Program). 2005. Alcoholic Beverage Consumption. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/alcoholicbeverageconsumption.pdf

NTP (National Toxicology Program). 2005. Naphthalene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/naphthalene.pdf

  • Type: Proposed
  • March 26, 2010
  • 75 FR 14769
75-07-0
71-43-2
106-99-0
91-20-3
2009 EPA
Public Availability of Identities of Inert Ingredients in Pesticides

In response to two petitions seeking disclosure of selected inert ingredients on pesticide labels, based on hazard, EPA is initiating rulemaking to increase public availability of the identities of the inert ingredients in pesticide products. This action would assist consumers and users of pesticides in making informed decisions and reduce the presence of potentially hazardous ingredients in pesticides.

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • December 23, 2009
  • 74 FR 68215
NA
2009 EPA
Lead; Amendment to the Opt-out and Recordkeeping Provisions in the Renovation, Repair, and Painting Program

EPA proposes several revisions to the Lead Renovation, Repair, and Painting Program (RRP) rule that published in the Federal Register on April 22, 2008. The rule establishes accreditation, training, certification, and recordkeeping requirements, as well as work practice standards on persons performing renovations for compensation in most pre-1978 housing and child-occupied facilities. In this document, EPA proposes eliminating the ‘‘opt-out’’ provision that currently exempts a renovation firm from the training and work practice requirements of the rule where the firm obtains a certification from the owner of a residence he or she occupies that no child under age 6 or pregnant women resides in the home and the home is not a child- occupied facility. EPA also proposes requiring renovation firms to provide a copy of the records demonstrating compliance with the training and work practice requirements of the RRP rule to the owner and, if different, the occupant of the building being renovated or the operator of the child-occupied facility.

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • October 28, 2009
  • 74 FR 55506
7439-92-1
2009 OSHA
Hazard Communication

OSHA proposes to modify its existing Hazard Communication Standard (HCS) to conform with the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). OSHA has preliminarily determined that the proposed modifications will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries.

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • September 30, 2009
  • 74 FR 50379
NA
2009 EPA
Proposed Rulemaking To Establish Light-Duty Vehicle Greenhouse Gas Emission Standards and Corporate Average Fuel Economy Standards

EPA and NHTSA are issuing this joint proposal to establish a National Program consisting of new standards for light-duty vehicles that will reduce greenhouse gas emissions and improve fuel economy. This joint proposed rulemaking is consistent with the National Fuel Efficiency Policy announced by President Obama on May 19, 2009, responding to the country’s critical need to address global climate change and to reduce oil consumption. EPA is proposing greenhouse gas emissions standards under the Clean Air Act, and NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, covering model years 2012 through 2016, and represent a harmonized and consistent National Program. Under the National Program, automobile manufacturers would be able to build a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices.

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • September 28, 2009
  • 74 FR 49553
71-43-2
106-99-0
75-07-0
91-20-3
2009 NIOSH
Request for Information on 1-Bromopropane

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on the brominated organic solvent, 1-Bromopropane (1–BP, CAS # 106–94–5, also known as n-propyl bromide), and develop appropriate communication documents, such as a Current Intelligence Bulletin, Criteria Document and/or other informational products, and establish a Recommended Exposure Limit (REL) for 1–BP. NIOSH is requesting information on the following: (1) published and unpublished reports and findings from in vitro and in vivo toxicity studies with 1–BP, (2) information on possible health effects observed in workers exposed to 1–BP, (3) information on workplaces and products in which 1–BP can be found, (4) description of work tasks and scenarios with a potential for exposure to 1–BP, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to 1–BP occur.

NTP Information Cited

National Toxicology Program (NTP). 2011. 1-Bromopropane (CASRN 106-94-5). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-564.
https://cebs.niehs.nih.gov/cebs/publication/TR-564

  • Type: Notice
  • September 16, 2009
  • 74 FR 47593
106-94-5
2009 OEHHA
Announcement of Publication of The Final Public Health Goal For 1,2,3-Trichloropropane In Drinking Water

Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is announcing the availability of the final technical support document for the Public Health Goal (PHG) for the solvent 1,2,3-trichloropropane in drinking water. This document establishes a PHG for 1,2,3-trichloropropane of 0.0007 parts per billion, versus the current Notification Level of 0.005 ppb, set in 2005. The PHG is based on an updated cancer potency calculation.

NTP Information Cited

National Toxicology Program (NTP). 1982. Carcinogenesis bioassay of 1,2-dibromo-3-chloropropane (CASRN 96-12-8) in F344/N rats and B6C3F1 mice (inhalation studies). TR-206.
https://ntp.niehs.nih.gov/go/tr206abs
National Toxicology Program (NTP). 1993. Toxicology and carcinogenesis of 1,2,3-trichloropropane (CASRN 96-18-4) in F344/N Rats and B6C3F1 Mice (gavage studies). TR-384.
https://ntp.niehs.nih.gov/go/tr384abs 
National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • August 20, 2009
  • Public Health Goals
96-18-4
2009 EPA
Amine Salts of Alkyl (C8-C24) Benzenesulfonic Acid (Dimethylaminopropylamine, Isopropylamine, Mono-, Di-, and Triethanolamine); Exemption from the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of amine salts of alkyl (C8-C24) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono-, di-, and triethanolamine) when used as an inert ingredient in pesticide formulations applied to growing crops and applied to animals. The Joint Inerts Task Force, Cluster Support Team Number 8, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of amine salts of alkyl (C8-C24) benzenesulfonic acid (dimethyl aminopropylamine, isopropylamine, mono-, di, and triethanolamine).

NTP Information Cited
National Toxicology Program (NTP). 1992. Toxicology and Carcinogenesis Studies of Diethanolamine (CASRN 111-42-2). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-478.
https://cebs.niehs.nih.gov/cebs/publication/TR-478

  • Type: Final Rule
  • August 05, 2009
  • 74 FR 38924
111-42-2
2009 OEHHA
Announcement of Publication of the Final Public Health Goal for Tri­chloro­ethyl­ene in Drinking Water

OEHHA within the California Environmental Protection Agency is announcing the availability of the final technical support document for the Public Health Goal (PHG) for the solvent tri­chloro­ethyl­ene in drinking water. This document increases the PHG for tri­chloro­ethyl­ene to 1.7 parts per billion, versus 0.8 ppb in the original PHG published in 1999. The PHG is based on the same cancer endpoint with an updated potency calculation.

NTP Information Cited

National Toxicology Program (NTP). 1988. Toxicology and Carcinogenesis Studies of Trichloroethyl­ene (CAS No. 79-01-6) in Four Strains of Rats (ACI, August, Marshall, Osborne-Mendel) (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-273. 
https://ntp.niehs.nih.gov/go/tr273abs

National Toxicology Program (NTP). 1990. Carcinogenesis Studies of Trichloroethylene (without Epichlorohydrin) (CASRN 79-01-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-243.
https://ntp.niehs.nih.gov/go/tr243abs

  • Type: Notice
  • July 09, 2009
  • Public Health Goals
79-01-6
2009 EPA
Residues of Silver in Foods from Food Contact Surface Sanitizing Solutions; Exemption from the Requirement of a Tolerance

This regulation amends the exemption from the requirement of a tolerance for residues of silver (excludes silver salts) in or on all foods when applied or used in public eating places, dairy processing equipment, and food processing equipment. ETO H2O, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act requesting to establish concentration limits for silver in end-use solutions eligible for tolerance exemption. The regulation being established will exempt all foods from the requirement of a tolerance for residues of silver resulting from contact with surfaces treated with solutions in which the end-use concentration of silver is not to exceed 50 parts per million (ppm).

NTP Information Cited

National Toxicology Program (NTP). 2002. Developmental Toxicity Evaluation for Silver Acetate (CASRN 563-63-3) Administered by Gavage to Sprague-Dawley Rats on Gestational Days 6-19. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TER20001.
https://ntp.niehs.nih.gov/go/ter20001abs

  • Type: Final Rule
  • June 10, 2009
  • 74 FR 27447
NA
2009 EPA
Regulation of Fuels and Fuel Additives: Changes to Renewable Fuel Standard Program

Under the Clean Air Act, as amended by Sections 201, 202, and 210 of the Energy Independence and Security Act of 2007, the Environmental Protection Agency is required to promulgate regulations implementing changes to the Renewable Fuel Standard program.

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Proposed
  • May 26, 2009
  • 74 FR 25053
75-07-0
71-43-2
106-99-0
64-17-5
91-20-3
2009 OEHHA
Announcement of Publication of The Final Public Health Goals for Lead, Oxamyl and Pentachlorophenol In Drinking Water

A revised Public Health Goal (PHG) of 0.3 parts per billion (ppb) is hereby established for pentachlorophenol (PCP) in drinking water, based on carcinogenicity. The earlier PHG for PCP of 0.4 ppb, developed in 1997, is based on the same rodent carcinogenicity data and a cancer potency value identical to that used in this revised PHG.

NTP Information Cited

National Toxicology Program (NTP). 1989. Toxicology and Carcinogenesis Studies of Two Pentachlorophenol (CASRN 87-86-5) Technical-Grade Mixtures in B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-349.
https://ntp.niehs.nih.gov/go/tr349abs

National Toxicology Program (NTP). 1999. Toxicology and Carcinogenesis Studies of Pentachlorophenol (CASRN 87-86-5) in F344/N Rats (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-483.
https://ntp.niehs.nih.gov/go/tr483abs

  • Type: Notice
  • April 24, 2009
  • Public Health Goals
87-86-5
2009 OEHHA
Announcement of Publication of The Final Public Health Goals for Lead, Oxamyl and Pentachlorophenol In Drinking Water

The purpose of this document is to review and evaluate the new data since 1997 regarding the toxicity of lead that are relevant to the estimation of a public health-protective level in drinking water, and establish any necessary changes in the previous risk assessment based on the new findings. This document is centered on updating the earlier OEHHA assessments for drinking water (OEHHA, 1997a, 2007).

NTP Information Cited

National Toxicology Program (NTP). 2009. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • April 24, 2009
  • Public Health Goals
2008 EPA
Diflubenzuron; Pesticide Tolerances for Emergency Exemptions

This regulation establishes time-limited tolerances for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline in or on alfalfa, forage and alfalfa, hay. This action is in response to EPAs granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on alfalfa and mixed grass/alfalfa fields. This regulation establishes a maximum permissible level for residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in these food commodities. The time-limited tolerances expire and are revoked on December 31, 2011.

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Para-chloroaniline Hydrochloride (CASRN 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies).  Research Triangle Park, NC: National Toxicology Program. Technical Report 351. https://ntp.niehs.nih.gov/go/tr351abs

  • Type: Final Rule
  • November 28, 2008
  • 73 FR 72352
20265-96-7
2008 EPA
Inert Ingredient: Exemption from the Requirement of a Tolerance for (S,S)­Ethylene­di­amine­di­succinic Acid

This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)­Ethylene­di­amine­di­succinic Acid (CAS Reg. No. 20846-91-7) ((S,S)EDDS) when used as an inert ingredient sequestrant or chelating agent in pesticide formulations applied to growing crops only under 40 CFR 180.920. Associated Octel Company, Limited, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)Ethylenediaminedisuccinic acid.

NTP Information Cited
National Cancer Institute (NCI). 1977. NCI Technical Report on the Bioassay of Trisodium Ethylen ediaminetetraacetate Trihydrate (EDTA) for Possible Carcinogenicity. Bethesda, MA: National Cancer Institute. Technical Report 011. https://ntp.niehs.nih.gov/go/tr011abs

  • Type: Final Rule
  • November 14, 2008
  • 73 FR 67397
CAS No. 150-38-9
2008 EPA
National Ambient Air Quality Standards for Lead

Based on its review of the air quality criteria and national ambient air quality standards (NAAQS) for lead (Pb), EPA is making revisions to the primary and secondary NAAQS for Pb to provide requisite protection of public health and welfare, respectively. With regard to the primary standard, EPA is revising the level to 0.15 μg/m3. EPA is retaining the current indicator of Pb in total suspended particles (Pb-TSP). EPA is revising the averaging time to a rolling 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period. EPA is revising the secondary standard to be identical in all respects to the revised primary standard.

NTP Information Cited

NTP (National Toxicology Program). 2005. Lead and Lead Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/lead.pdf

  • Type: Final Rule
  • November 12, 2008
  • 73 FR 66964
NA
2008 EPA
Sixty-Third Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its 63rd Report to the Administrator of the EPA on October 7, 2008. In the 63rd ITC report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing 1 tungsten compound and 1 High Production Volume (HPV) Challenge Program orphan chemical.

NTP Information Cited
National Toxicology Program December 9-10, 2008 Report on Carcinogens (RoC) Expert Panel Meeting: Cobalt-Tungsten Carbide Powders and Hard Metals. https://ntp.niehs.nih.gov/go/849588 [accessed 12 July 2022]

  • Type: Notice
  • November 03, 2008
  • 73 FR 65486
10213-10-2
2008 EPA
Control of Emissions From Nonroad Spark-Ignition Engines and Equipment

We are setting emission standards for new non-road spark-ignition engines that will substantially reduce emissions from these engines. The exhaust emission standards apply starting in 2010 for new marine spark-ignition engines, including first-time EPA standards for stern-drive and inboard engines. The exhaust emission standards apply starting in 2011 and 2012 for different sizes of new land-based, spark-ignition engines at or below 19 kilowatts (kW). These small engines are used primarily in lawn and garden applications. We are also adopting evaporative emission standards for vessels and equipment using any of these engines. In addition, we are making other minor amendments to our regulations.

NTP Information Cited
NTP (National Toxicology Program). 2005. Benzene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf

NTP (National Toxicology Program). 2005. 1,3-Butadiene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/butadiene.pdf

NTP (National Toxicology Program). 2005. Acetaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acetaldehyde.pdf

NTP (National Toxicology Program). 2005. Naphthalene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/naphthalene.pdf

  • Type: Final Rule
  • October 08, 2008
  • 73 FR 59034
71-43-2
106-99-0
75-07-0
91-20-3
2008 EPA
Dichlorvos (DDVP); Order Denying NRDCs Objections and Requests for Hearing

In this order, EPA denies objections to, and requests for hearing on, a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objections and hearing requests were filed on February 1, 2008, by the Natural Resources Defense Council (NRDC). The Original petition was also filed by NRDC.

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Dichlorvos (CASRN 62-73-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies).  Research Triangle Park, NC: National Toxicology Program. Technical Report 342. https://ntp.niehs.nih.gov/go/tr342abs

  • Type: Other
  • July 23, 2008
  • 73 FR 42683
62-73-7
2008 EPA
Control of Emissions of Air Pollution from Locomotive Engines and Marine Compression-Ignition Engines Less than 30 Liters per Cylinder; Republication

EPA is adopting a comprehensive program to dramatically reduce pollution from locomotives and marine diesel engines. The controls will apply to all types of locomotives, including line-haul, switch, and passenger, and all types of marine diesel engines below 30 liters per cylinder displacement, including commercial and recreational, propulsion and auxiliary. The near-term emission standards for newly-built engines will phase in starting in 2009. The near-term program also includes new emission limits for existing locomotives and marine diesel engines that apply when they are remanufactured, and take effect as soon as certified remanufacture systems are available, as early as 2008. The long-term emissions standards for newly-built locomotives and marine diesel engines are based on the application of high-efficiency catalytic after-treatment technology. These standards begin to take effect in 2015 for locomotives and in 2014 for marine diesel engines. We estimate particulate matter (PM) reductions of 90 percent and nitrogen oxides (NOX) reductions of 80 percent from engines meeting these standards, compared to engines meeting the current standards.

NTP Information Cited

NTP (National Toxicology Program). 2005. Naphthalene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/naphthalene.pdf

NTP (National Toxicology Program). 2005. Benzene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf

NTP (National Toxicology Program). 2005. 1,3-Butadiene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/butadiene.pdf

NTP (National Toxicology Program). 2005. Acetaldehyde. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/acetaldehyde.pdf

  • Type: Final Rule
  • June 30, 2008
  • 73 FR 37096
91-20-3
71-43-2
106-99-0
75-07-0
2008 OEHHA
Chemical Listed Effective June 17, 2008 as Known to the State of California to Cause Cancer, Dibromoacetic acid (CAS No. 631-64-1)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding dibromoacetic acid (CAS No. 631-64-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of dibromoacetic acid is effective June 17, 2008. Toxicological endpoints: Reproductive Toxicity and Cancer

NTP Information Cited
National Toxicology Program (NTP). 2007. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Dibromoacetic Acid (CASRN 631-64-1) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies).  Research Triangle Park, NC: National Toxicology Program. Technical Report 537. https://ntp.niehs.nih.gov/go/tr537abs

  • Type: Notice
  • June 13, 2008
  • Proposition 65
631-64-1
2008 EPA
Sixty-Second Report of the TSCA Interagency Testing Committee to the Administrator of the Environmental Protection Agency; Receipt of Report and Request for Comments

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its sixty-second report to the Administrator of EPA on April 17, 2008. In the 62nd ITC Report, which is included with this notice, the ITC is revising the TSCA section 4(e) Priority Testing List by removing four tungsten compounds and four cresols.

NTP Information Cited
National Toxicology Program December 9-10, 2008 Report on Carcinogens (RoC) Expert Panel Meeting: Cobalt-Tungsten Carbide Powders and Hard Metals. https://ntp.niehs.nih.gov/go/849588 [accessed 12 July 2022]

  • Type: Notice
  • May 12, 2008
  • 73 FR 27450
1314-35-8
10213-10-2
2008 CPSC
Standard for the Flammability of Residential Upholstered Furniture

The United States Consumer Product Safety Commission (Commission or CPSC) is proposing flammability standards for residential upholstered furniture under the Flammable Fabrics Act (FFA). The proposal would establish performance requirements and certification and labeling requirements for upholstered furniture. Manufacturers of upholstered furniture would choose one of two possible methods of compliance: They could use cover materials that are sufficiently smolder resistant to meet a cigarette ignition performance test; or they could place fire barriers that meet smoldering and open flame resistance tests between the cover fabric and interior filling materials. Manufacturers of upholstered furniture would be required to certify compliance with the standard and to comply with certain recordkeeping requirements as specified in the proposal.

NTP Information Cited
National Toxicology Program NTP Review of Halogenated Flame Retardants. https://ntp.niehs.nih.gov/go/hfr [accessed 12 July 2022].

  • Type: Notice
  • March 04, 2008
  • 73 FR 11702
NA
2008 OEHHA
Final Public Health Goal for Copper in Drinking Water

This Public Health Goal (PHG) technical support document provides information on health effects from copper in drinking water. PHGs are developed for chemical contaminants based on the best available toxicological data in the scientific literature. These documents and the analyses contained in them provide estimates of the levels of contaminants in drinking water that would pose no significant health risk to individuals consuming the water on a daily basis over a lifetime.

NTP Information Cited
National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicity Studies of Cupric Sulfate (CASRN 7758-99-8) Administered in Drinking Water and Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 29. https://ntp.niehs.nih.gov/go/tox29abs

  • Type: Notice
  • February 08, 2008
  • Public Health Goals
7758-99-8
2007 OEHHA
Final Public Health Goal for Water Soluble Polychlorinated Biphenyls (PCBs) Expected to be Found in Drinking Water

This Public Health Goal (PHG) technical support document provides information on health effects from Water Soluble Polychlorinated Biphenyls Expected to be Found in Drinking Water. PHGs are developed for chemical contaminants based on the best available toxicological data in the scientific literature. These documents and the analyses contained in them provide estimates of the levels of contaminants in drinking water that would pose no significant health risk to individuals consuming the water on a daily basis over a lifetime.

NTP Information Cited
NTP (National Toxicology Program). 2000. Report on Carcinogens, Ninth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • October 05, 2007
  • Public Health Goals
2007 OEHHA
Chemical Listed Effective September 28, 2007 as Known to the State of California to Cause Cancer: anthraquinone(CAS No. 84-65-1)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding anthraquinone (CAS No. 84-65-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of anthraquinone is effective September 28, 2007. Anthraquinone (CAS No. 84-65-1) is being listed as a chemical known to the State of California to cause cancer. The listing of this chemical is based on formal identification by an authoritative body (i.e., the National Toxicology Program (NTP)), that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the authoritative bodies mechanism can be found in Title 22, Cal. Code of Regs., section 12306. Toxicological endpoint: cancer

NTP Information Cited

National Toxicology Program (NTP). 2005. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Anthraquinone (CASRN 84-65-1) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 494. https://ntp.niehs.nih.gov/go/tr494abs

NTP (National Toxicology Program). 2005. Anthraquinone. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/aminoanthraquinone.pdf

  • Type: Notice
  • September 28, 2007
  • Proposition 65
84-65-1
2007 ATSDR
Intent To Develop Two Interaction Profiles

This notice announces the intent of ATSDR to develop two interaction profiles.

NTP Information Cited

National Toxicology Program (NTP). 1999. NTP Report on Carcinogens Background Document for 2,3, 7,8-Tetrachlorodibenzo-p-Dioxin (TCDD). Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/newhomeroc/other_background/tetrachl_tcdd_4apps_508.pdf

National Toxicology Program (NTP). 1979. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2,2N,4,4N,5,5N-Hexachlorobiphenyl (PCB 153) (CASRN 35065-27-1) in Female Harlan Sprague-Dawley Rats (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 529. https://ntp.niehs.nih.gov/go/tr529abs

National Cancer Institute (NCI). 1979. NCI Technical Report on the Bioassay of Fenthion (CASRN 55-38-9) for Possible Carcinogenicity. Bethesda, MA: National Cancer Institute. Technical Report 103. https://ntp.niehs.nih.gov/go/tr103abs

National Cancer Institute (NCI). 1979. NCI Technical Report on the Bioassay of Malathion (CASRN 121-75-5) for Possible Carcinogenicity. Bethesda, MA: National Cancer Institute. Technical Report 192. https://ntp.niehs.nih.gov/go/tr192abs

National Cancer Institute (NCI). 1978. NCI Technical Report on the Bioassay of Aroclor 1254 (CASRN 27323-18-8) for Possible Carcinogenicity. Bethesda, MA: National Cancer Institute. Technical Report 38. https://ntp.niehs.nih.gov/go/tr38abs

National Cancer Institute (NCI). 1979. NCI Technical Report on the Bioassay of Dibenzo p-dioxin (CASRN 262-12-4) for Possible Carcinogenicity. Bethesda, MA: National Cancer Institute. Technical Report 122. https://ntp.niehs.nih.gov/go/tr122abs

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-butyl Phthalate (DBP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dbp/dbp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isononyl Phthalate (DINP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dinp/dinp_monograph_final.pdf

National Toxicology Program (NTP). 2006. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-(2-ethylhexyl) Phthalate. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dehp/dehp-monograph.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-hexyl Phthalate. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnhp/dnhp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isodecyl Phthalate. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-octyl Phthalate. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnop/dnop_monograph_final.pdf

  • Type: Notice
  • July 03, 2007
  • 72 FR 36456
2007 OEHHA
Announcement of Publication of the Final Public Health Goal for Glyphosate in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goals (PHGs) for glyphosate, which is an update of the PHG published in 1997.

NTP Information Cited
National Toxicology Program (NTP). 1992. NTP Technical Report on the Toxicity Studies of Glyphosate (CASRN 1071-83-6) Administered in Dose Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: National Toxicology Program. Toxicity Report 16. https://ntp.niehs.nih.gov/go/tox16abs

  • Type: Notice
  • June 29, 2007
  • Public Health Goal
1071-83-6
2007 EPA
Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances-n-Propyl Bromide in Solvent Cleaning

The Environmental Protection Agency (EPA) determines that n-propyl bromide (nPB) is an acceptable substitute for methyl chloroform and chlorofluorocarbon (CFC)-113 in the solvent cleaning sector under the Significant New Alternatives Policy (SNAP) program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a substantially greater risk to public health and the environment than the substance they replace or than other available substitutes.

NTP Information Cited

NTP, 2003. Results of 13-week Inhalation Testing by the National Toxicology Program. https://ntp.niehs.nih.gov/go/717271

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 1-Bromopropane. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bromopropanes/1-bromopropane/1bp_monograph.pdf

  • Type: Final Rule
  • May 30, 2007
  • 72 FR 30142
2007 OEHHA
Chemical Listed Effective April 20, 2007 as Known to the State of California to Cause Reproductive Toxicity: di-isodecyl phthalate (DIDP)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding di-isodecyl phthalate (DIDP) (CAS No. 68515-49-1 and 26761-40-0) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of di-isodecyl phthalate (DIDP) is effective April 20, 2007.

NTP Information Cited

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-isodecyl Phthalate (DIDP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/didp/didp_monograph_final.pdf

  • Type: Notice
  • April 20, 2007
  • Proposition 65
68515-49-1
26761-40-0
2006 OEHHA
Final Public Health Goal for N-Nitrosodimethylamine and Cadmium in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goals (PHGs) for N-nitrosodimethylamine and cadmium.

NTP Information Cited

National Toxicology Program (NTP). 1999. Report on Carcinogens, Ninth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • December 22, 2006
  • Proposition 65
2006 OEHHA
Chemicals Delisted Effective December 8, 2006 from the List of Chemicals Known to the State of California to Cause Cancer, isosafrole, 5-nitro-o-anisidine, tris(aziridinyl)-p-benzoquinone

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is removing isosafrole [CAS No. 120-58-1], 5-nitro-o-anisidine [CAS No. 99-59-2], and tris(aziridinyl)-p-benzoquinone (triaziquone) [CAS No. 68-76-8] from the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The delisting of the three chemicals is effective December 8, 2006. 5-Nitro-o-anisidine was removed from the NTP Sixth Annual Report on Carcinogens as a substance reasonably anticipated to be a human carcinogen in 1991, when NTP concluded there was insufficient evidence of carcinogenicity.

NTP Information Cited

National Toxicology Program (NTP). 2004. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • December 08, 2006
  • Proposition 65
99-59-2
2006 EPA
Diflubenzuron; Pesticide Tolerances

This regulation establishes tolerances for combined residues of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on brassica, leafy greens subgroup 5B, turnip greens, peanut, peanut hay, peanut oil, barley grain, barley hay, barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain, wheat forage, wheat hay, wheat straw, aspirated grain fractions, and pummelo. The Interregional Research Project #4 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

NTP Information Cited

National Toxicology Program (NTP). 1989. Toxicology and Carcinogenesis Studies of Para-Chloroaniline Hydrochloride (CASRN 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-351.
https://ntp.niehs.nih.gov/go/tr351abs

  • Type: Final Rule
  • November 29, 2006
  • 71 FR 69028
35367-38-5
150-68-5
106-47-8
2006 EPA
Export Notification; Change to Reporting Requirements

EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment changes the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as "chemicals") for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is changing the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also promulgating de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, promulgating other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification), and clarifying exporters' and EPA's obligations where an export notification- triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action.

NTP Information Cited

National Toxicology Program (NTP). 2004. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • November 14, 2006
  • 71 FR 66234
2006 EPA
Eucalyptus Oil; Exemption from the Requirement of a Tolerance

This regulation establishes an exemption from the requirement of a tolerance for residues of eucalyptus oil on honey and honeycomb when applied at 2 g or less eucalyptus oil per hive to suppress varroa mites. Brushy Mountain Bee farm, c/o IR-4 Project submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of eucalyptus oil in honey and honeycomb.

NTP Information Cited

National Toxicology Program (NTP). Accessed 2022-07-27. 1,8-Cineole (470-82-6). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.  
https://doi.org/10.22427/NTP-DATA-DTXSID4020616

  • Type: Final Rule
  • September 13, 2006
  • 71 FR 53974
470-82-6
2006 FDA
Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule

The Food and Drug Administration is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

NTP Information Cited

National Toxicology Program (NTP). 1989. Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies).  Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-366.
https://ntp.niehs.nih.gov/go/tr366abs

  • Type: Proposed
  • August 29, 2006
  • 71 FR 51146
123-31-9 and 497-76-7
2006 MSHA
Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners

This final rule revises the May 20, 2006 effective date of the diesel particulate matter (DPM) final concentration limit of 160 micrograms of total carbon (TC) per cubic meter of air (160TC ug/m3) promulgated in the 2001 final rule "Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners," and published in the Federal Register on January 19, 2001 (66 FR 5706) and amended on September 19, 2005 (70 FR 55019).

NTP Information Cited

National Toxicology Program (NTP). 2002. Report on Carcinogens, Tenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • May 18, 2006
  • 71 FR 28924
2006 EPA
Ethylene Oxide Emissions Standards for Sterilization Facilities

This action finalizes our decision not to revise the Ethylene Oxide Emission Standards for Sterilization Facilities, originally promulgated on December 6, 1994. Within 8 years of promulgating these standards, the Clean Air Act directs us to assess the risk and to promulgate more stringent standards if necessary to protect public health with an ample margin of safety and to prevent adverse environmental effects. Also, within 8 years of promulgating the national emission standards, the Clean Air Act requires us to review and revise the standards as necessary, taking into account developments in practices, processes, and control technologies. Today¿s action reflects our findings that after conducting these risk and technology reviews, no additional control requirements are warranted.

NTP Information Cited

National Toxicology Program (NTP). 2002. Report on Carcinogens, Tenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • April 07, 2006
  • 71 FR 17712
2006 EPA
Testing of Certain High Production Volume Chemicals

EPA is promulgating a final rule under the Toxic Substances Control Act that requires manufacturers (including importers) and processors of 17 high production volume chemicals to conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing.

NTP Information Cited

National Toxicology Program (NTP). 1989. Toxicology and Carcinogenesis Studies of Pentaerythritol Tetranitrate (CASRN 78-11-5) with 80% D-Lactose Monohydrate (PETN, NF) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-365.
https://ntp.niehs.nih.gov/go/tr365abs

  • Type: Final Rule
  • March 16, 2006
  • 71 FR 13708
78-11-5
2006 EPA
Ethylenediaminetetraacetic Acid Chemicals: Exemptions from the Requirement of a Tolerance

The Agency is proposing to establish 16 new and amend three existing exemptions from the requirement of a tolerance for residues of various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these EDTA chemicals.

NTP Information Cited

National Toxicology Program (NTP). 1977. Bioassay of Trisodium Ethylenediaminetetraacetate Trihydrate (EDTA) (CASRN 150-38-9) for Possible Carcinogenicity. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-11.
https://ntp.niehs.nih.gov/go/tr011abs

  • Type: Proposed
  • March 08, 2006
  • 71 FR 11563
150-38-9
2006 OEHHA
Announcement of Publication of the Final Technical Support Documents for the Public Health Goal and Responses to Comments for Six Chemicals in Drinking Water

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited

National Toxicology Program (NTP). 2002. Toxicity Studies of Trans-1,2-Dichloroethylene (CASRN 156-60-5) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TOX-55.
https://ntp.niehs.nih.gov/go/tox55abs

National Toxicology Program (NTP). 1987. Developmental Toxicity Evaluation of 1,1,1-Trichloroethane (CASRN 71-55-6) Administered to CD Rats. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. T0151.
https://ntp.niehs.nih.gov/go/t0151abs

National Toxicology Program (NTP). 1987. Developmental Toxicity Evaluation of 1,1,1-T.richloroethane Administered in Drinking Water to CD Rats. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. T0179.
https://ntp.niehs.nih.gov/go/t0179abs

National Toxicology Program (NTP). 1996. Technical Report on Renal Toxicity Studies of Selected Halogenated Ethanes to F344/N Rats (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TOX-45.
https://ntp.niehs.nih.gov/go/tox45abs

National Toxicology Program (NTP). 2000. Technical Report on the Toxicity Studies of 1,1,1-Trichloroethane (CASRN 71-55-6) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TOX-41.
https://ntp.niehs.nih.gov/go/tox41abs

  • Type: Notice
  • March 06, 2006
  • Proposition 65
156-60-5
2006 OEHHA
Announcement of Publication of the Final Technical Support Documents for the Public Health Goal and Responses to Comments for Six Chemicals in Drinking Water

In accordance with Health and Safety Code Section 116293 (SB1822, Sher, Statutes of 2002), the Office of Environmental Health Hazard Assessment (OEHHA) hereby publishes the final Public Health Goal (PHG) for cis/trans-1,2-dichloroethylene, 1,1,1-trichloroethane, 1,1,2-trichloroethane, radium-226 and 228, strontium-90, and tritium in drinking water. OEHHA has completed technical support documents that provide the scientific basis for the PHGs.

NTP Information Cited
NTP (1988). Developmental toxicity evaluation of 1,1,1-trichloroethane (CAS No. 7l-55-6) administered to CD rats. Final report part 2. TO151 and TO179.

NTP (1996). Technical report on renal toxicity studies of selected halogenated ethanes administered by gavage to F344/N rats. Toxicity Report Series. TOX-45

NTP (2000). Technical report on the toxicity studies of 1,1,1-trichloroethane (CAS No. 71-55-6) administered in microcapsules in feed to F344/N rats and B6C3F1 mice. TOX-41

  • Type: Notice
  • March 06, 2006
  • Proposition 65
71-55-6
2006 OSHA
Occupational Exposure to Hexavalent Chromium

The Occupational Safety and Health Administration (OSHA) is amending the existing standard which limits occupational exposure to hexavalent chromium (Cr(VI)). OSHA has determined based upon the best evidence currently available that at the current permissible exposure limit (PEL) for Cr(VI), workers face a significant risk to material impairment of their health.

NTP Information Cited

National Toxicology Program (NTP). 1980. Report on Carcinogens, First Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • February 28, 2006
  • 71 FR 10100
18540-29-9
2006 EPA
National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule

The Environmental Protection Agency (EPA) is promulgating today's final rule, the Stage 2 Disinfectants and Disinfection Byproducts Rule (DBPR), to provide for increased protection against the potential risks for cancer and reproductive and developmental health effects associated with disinfection byproducts (DBPs).

NTP Information Cited

National Toxicology Program (NTP). 1987. Toxicity and Carcinogenesis Studies of Bromodichloromethane (CASRN 75-27-4) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-321. https://ntp.niehs.nih.gov/go/tr321abs

National Toxicology Program (NTP). 2004. Toxicology and Carcinogenesis Studies of Sodium Chlorate (CASRN 7775-09-9) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies)—Draft Abstract. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-517. https://ntp.niehs.nih.gov/go/tr517abs

National Toxicology Program (NTP). 2005. Toxicology and Carcinogenesis Studies of Bromodichloromethane (CASRN 75-27-4) in Male F344/N Rats and Female B6C3F1 Mice (Drinking Water Studies)—Draft Abstract. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. TR-532. https://ntp.niehs.nih.gov/go/tr532abs

National Toxicology Program (NTP). 2005. Dibromoacetic Acid (631-64-1). Chemical Effects in Biological Systems (CEBS). Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.
https://cebs.niehs.nih.gov/cebs/test_article/631-64-1

  • Type: Final Rule
  • January 04, 2006
  • 71 FR 388
75-27-4
7775-09-9
and 631-64-1
2005 EPA
National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities

EPA is proposing revised standards to limit emissions of perchloroethylene (PCE) from existing and new dry cleaning facilities.

NTP Information Cited
National Toxicology Program (NTP). 1986. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Tetrachloroethylene (Perchloroethylene) (CASRN 127-18-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 311. https://ntp.niehs.nih.gov/go/tr311abs

  • Type: Proposed
  • December 21, 2005
  • 70 FR 75884
127-18-4
2005 EPA
List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List

EPA is amending the list of hazardous air pollutants contained in section 112 of the Clean Air Act by removing the compound methyl ethyl ketone (MEK) (2-Butanone) (CAS No. 78-93-3). This action is being taken in response to a petition submitted by the Ketones Panel of the American Chemistry Council (formerly the Chemical Manufacturers Association) on behalf of MEK producers and consumers to delete MEK from the HAP list. Petitions to remove a substance from the HAP list are permitted under section 112 of the CAA.

NTP Information Cited
National Toxicology Program (NTP). 1990. Inhalation Developmental Toxicology Studies: Teratology Study of Methyl Ethyl Ketone (CASRN 78-93-3) in Mice. NTP Study TER88046. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/go/ter88046abs

National Toxicology Program (NTP). 2007. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Methyl Isobutyl Ketone (CASRN 108-10-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 538. https://ntp.niehs.nih.gov/go/tr538abs

  • Type: Final Rule
  • December 19, 2005
  • 70 FR 75047
78-93-3
108-10-1
2005 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Synthetic Fatty Alcohols

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of n-octanol (n-octyl alcohol) produced by a new manufacturing process, the hydrodimerization of 1,3-butadiene. This action is in response to a petition filed by Kuraray International Corp.

NTP Information Cited
National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1,3-Butadiene (CASRN 106-99-0) in B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 434. https://ntp.niehs.nih.gov/go/tr434abs

  • Type: Final Rule
  • December 08, 2005
  • 70 FR 72906
106-99-0
2005 OEHHA
Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity: butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005 Toxicological endpoint: cancer. Toxicological endpoints: Developmental toxicity, Female reproductive toxicity, and Male reproductive toxicity

NTP Information Cited

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/bb-phthalate/bbp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dbp/dbp_monograph_final.pdf

National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/phthalates/dnhp/dnhp_monograph_final.pdf

  • Type: Notice
  • December 02, 2005
  • Proposition 65
85-68-7
84-74-2
84-75-3
2005 OEHHA
Chemicals Listed Effective August 19, 2005 as Known to the State of California to Cause Cancer: estrogens, steroidal

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding estrogens, steroidal to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of estrogens, steroidal is effective August 19, 2005.

NTP Information Cited
NTP (National Toxicology Program). 2002. Report on Carcinogens, Tenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • August 19, 2005
  • Proposition 65
Steroidal Estrogens (as a class)
2005 MSHA
Asbestos Exposure Limit

MSHA is proposing to revise their existing health standards for asbestos exposure at metal and nonmetal mines, surface coal mines, and surface areas of underground coal mines. The proposed rule would reduce the full-shift permissible exposure limit and the excursion limit for airborne asbestos fibers, and make several nonsubstantive changes to add clarity to the standard. Exposure to asbestos has been associated with lung and other cancers, mesotheliomas, and asbestosis. This proposed rule would help assure that fewer miners who work in an environment where asbestos is present would suffer material impairment of health or functional capacity over their working lifetime.

NTP Information Cited
NTP (National Toxicology Program). 2005. Asbestos. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf

  • Type: Proposed
  • July 29, 2005
  • 70 FR 43950
1332-21-4
2005 MSHA
Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners

In this final rule: MSHA revises the existing standards addressing diesel particulate matter (DPM) exposure in underground metal and nonmetal (M/NM) mines; changes the interim concentration limit measured by total carbon to a comparable permissible exposure limit measured by elemental carbon, which renders a more accurate DPM exposure measurement; increases flexibility of compliance for mine operators by requiring longstanding hierarchy of controls for its other exposure-based health standards at M/NM mines, but retains the prohibition on rotation of miners for compliance; requires MSHA to consider economic as well as technological feasibility in determining if operators qualify for an extension of time in which to meet the final DPM limit; deletes the requirement for a control plan; and makes conforming changes to existing provisions concerning compliance determinations, environmental monitoring and recordkeeping.

NTP Information Cited

NTP (National Toxicology Program). 2002. Report on Carcinogens, Tenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

NTP (National Toxicology Program). 2002. Diesel Exhaust Particulates. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/dieselexhaustparticulates.pdf

  • Type: Final Rule
  • June 06, 2005
  • 70 FR 32868
2005 OEHHA
Chemicals Listed Effective May 27, 2005 and May 31, 2005 as known to the State of California to Cause Cancer or Reproductive Toxicity

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 2-bromopropane (2-BP) (CAS No. 75-26-3)...to the list of chemicals known to the state to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of... 2-bromopropane (2-BP) is effective May 31, 2005. Toxicological endpoint: Female reproductive and male reproductive toxicity

NTP Information Cited
National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 2-Bromopropane. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bromopropanes/2-bromopropane/2bp_monograph.pdf

  • Type: Notice
  • May 31, 2005
  • Proposition 65
75-26-3
2005 OEHHA
Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited
NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • May 20, 2005
  • Proposition 65
10124-43-3
2005 OEHHA
Chemicals Listed Effective May 20, 2005 as Known to the State of California to Cause Cancer: Cobalt sulfate, Diazoaminobenzene

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding cobalt sulfate (CAS No. 10124-43-3) and diazoaminobenzene (CAS No. 136-35-6) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of cobalt sulfate and diazoaminobenzene is effective May 20, 2005. Toxicological Endpoint: cancer

NTP Information Cited

NTP (National Toxicology Program). 2005. Diazoaminobenzene. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/diazoaminobenzene.pdf

NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • May 20, 2005
  • Proposition 65
136-35-6
2005 EPA
Isophorone; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

NTP Information Cited
National Toxicology Program (NTP). 1986. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Isophorone (CASRN 78-59-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 291. https://ntp.niehs.nih.gov/go/tr291abs

  • Type: Notice
  • April 27, 2005
  • 70 FR 21767
78-59-1
2005 OSHA
Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide

The Occupational Safety and Health Administration (OSHA) has conducted a review of its Ethylene Oxide (EtO) Standard pursuant to section 610 of the Regulatory Flexibility Act and section 5 of Executive Order 12866 on Regulatory Planning and Review.

NTP Information Cited
National Toxicology Program (NTP). 1987. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Ethylene Oxide (CASRN 75-21-8) in B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 326. https://ntp.niehs.nih.gov/go/tr326abs

  • Type: Notice
  • April 22, 2005
  • 70 FR 20807
75-21-8
2005 FDA
Food Additives Permitted for Direct Addition to Food for HumanConsumption; Acacia (Gum Arabic)

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acacia (gum arabic) as a thickener, emulsifier, or stabilizer in alcoholic beverages at a maximum use level of 20 percent. This action is in response to a petition filed by Kerry, Inc.

NTP Information Cited
National Toxicology Program (NTP). 1982. NTP Technical Report on the Carcinogenesis Bioassay of Gum Arabic (CASRN 9000-01-5) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 227. https://ntp.niehs.nih.gov/go/tr227abs

  • Type: Final Rule
  • February 17, 2005
  • 70 FR 8032
9000-01-5
2005 OEHHA
Chemical Listed Effective February 11, 2005 as Known to the State of California to Cause Cancer: Vanadium Pentoxide

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding vanadium pentoxide (orthorhombic crystalline form) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of the chemical is effective February 11, 2005. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP). 2002. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Vanadium Pentoxide (CASRN 1314-62-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 507. https://ntp.niehs.nih.gov/go/tr507abs

  • Type: Notice
  • February 11, 2005
  • Proposition 65
1314-63-1
2005 CPSC
Standard for the Flammability (Open Flame) of Mattresses and Mattress/Foundation Sets; Notice of Proposed Rulemaking

The Commission is proposing a flammability standard under the authority of the Flammable Fabrics Act that would address open flame ignition of mattresses and mattress and foundation sets ("mattresses/sets").

NTP Information Cited
National Toxicology Program NTP Review of Halogenated Flame Retardants. https://ntp.niehs.nih.gov/go/hfr

  • Type: Proposed
  • January 13, 2005
  • 70 FR 2470
2005 FDA
Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients.

NTP Information Cited
National Toxicology Program (NTP). 2007. NTP Technical Report on the Photocarcinogenesis Study of Glycolic Acid and Salicylic Acid (CASRN 79-14-1 and 69-72-7) in SKH-1 Mice (Simulated Solar Light and Topical Application Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 524. https://ntp.niehs.nih.gov/go/tr524abs

  • Type: Notice
  • January 10, 2005
  • 70 FR 1721
79-14-1 and 69-72-7
2004 OEHHA
Chemical Listed Effective December 7, 2004 as known to the State of California to Cause Reproductive Toxicity: 1-Bromopropane (1-BP)

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 1-bromopropane (1-BP) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of the chemical is effective December 7, 2004. Toxicological Endpoint: Developmental, female reproductive and male reproductive toxicity

NTP Information Cited
National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 1-Bromopropane. Research Triangle Park, NC: Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/bromopropanes/1-bromopropane/1bp_monograph.pdf

  • Type: Notice
  • December 07, 2004
  • Proposition 65
106-94-5
2004 OEHHA
Chemical Listed Effective December 3, 2004 as known to the State of California to Cause Cancer: Riddelliine

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding riddelliine to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of riddelliine is effective December 3, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
NTP (National Toxicology Program). 2011. Riddelliine. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/riddelliine.pdf

National Toxicology Program (NTP). 2003. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Riddelliine (CASRN 23246-96-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 508. https://ntp.niehs.nih.gov/go/tr508abs

  • Type: Notice
  • December 03, 2004
  • Proposition 65
23246-96-0
2004 EPA
List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List; Petition To Delist of Ethylene Glycol Monobutyl Ether

The EPA is amending the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing the compound ethylene glycol monobutyl ether (EGBE) (2-Butoxyethanol)(CAS No. 111-76-2) from the group of glycol ethers.

NTP Information Cited
National Toxicology Program (NTP). 2000a. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2-Butoxyethanol (CASRN 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 484. https://ntp.niehs.nih.gov/go/tr484abs

  • Type: Final Rule
  • November 29, 2004
  • 69 FR 69320
111-76-2
2004 OSHA
Occupational Exposure to Hexavalent Chromium

OSHA proposes to amend its existing standard for employee exposure to hexavalent chromium (Cr(VI)). The basis for issuance of this proposal is a preliminary determination by the Assistant Secretary that employees exposed to Cr(VI) face a significant risk to their health at the current permissible exposure limit and that promulgating this proposed standard will substantially reduce that risk.

NTP Information Cited
NTP (National Toxicology Program). 1980. Chromium Hexavalent Compounds. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/chromiumhexavalentcompounds.pdf

National Toxicology Program (NTP). 1997. Reproductive Toxicity of Potassium Dichromate (Hexavalent) (CASRN 7778-50-9) Administered in Diet to BALB/c Mice. Research Triangle Park, NC. https://ntp.niehs.nih.gov/go/racb94014abs

National Toxicology Program (NTP). 1996. Reproductive Toxicity (Testicular) of Potassium Dichromate (Hexavalent) (CASRN 7778-50-9) Administered in Diet to BALB/c Mice. https://ntp.niehs.nih.gov/go/racb95002abs

National Toxicology Program (NTP). 1996. Reproductive Toxicity of Potassium Dichromate (Hexavalent) (CASRN 7778-50-9) Administered in Diet to SD Rats. https://ntp.niehs.nih.gov/go/racb95001abs

  • Type: Proposed
  • October 04, 2004
  • 69 FR 59305
13765-19-0
7778-50-9
2004 EPA
National Emission Standards forHazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers and Process Heaters

The EPA is promulgating national emission standards for hazardous air pollutants for industrial, commercial, and institutional boilers and process heaters and has identified industrial, commercial, and institutional boilers and process heaters as major sources of hazardous air pollutants.

NTP Information Cited
National Toxicology Program (NTP). 1992. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Chlorinated Water and Chloraminated Water (Deionized and Charcoal-Filtered) (CASRNs 7782-50-5, 7681-52-9 and 10599-90-3) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 392. https://ntp.niehs.nih.gov/go/tr392abs

  • Type: Final Rule
  • September 13, 2004
  • 69 FR 55217
7782-50-5
7681-52-9
10599-90-3
2004 OEHHA
Chemicals Listed Effective July 9, 2004 as Known to the State of California to Cause Cancer: aristolochic acids and herbal remedies containing plant species of the genus Aristolochia

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding aristolochic acids and herbal remedies containing plant species of the genus Aristolochia to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of "aristolochic acids and herbal remedies containing plant species of the genus Aristolochia is effective July 9, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
NTP (National Toxicology Program). 2011. Aristolochic Acids. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/aristolochicacids.pdf

  • Type: Notice
  • July 09, 2004
  • Proposition 65
Aristolochia
2004 Treasury
Removal of Requirement To Disclose Saccharin in the Labeling of Wine, Distilled Spirits, and Malt Beverages

Amends the Alcohol and Tobacco Tax and Trade Bureau's labeling regulations to remove the requirement for bottlers of wine, distilled spirits, and malt beverages to show a warning on products containing saccharin. The regulatory amendments in this document reflect the National Toxicology Program's revised findings about saccharin and the removal of the statutory requirement for the warning.

NTP Information Cited
NTP (National Toxicology Program). 1980. Report on Carcinogens, First Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

NTP (National Toxicology Program). 2000. Report on Carcinogens, Ninth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Final Rule
  • June 16, 2004
  • 69 FR 33572
81-07-2
2004 OEHHA
Chemicals Listed Effective June 11, 2004 as Known to the State of California to Cause Cancer: propylene glycol mono-t-butyl ether; 3,3'-dimethylbenzidine (DMB)-based dyes metabolized to 3,3'-dimethylbenzidine; 3,3'-dimethoxybenzidine-based dyes metabolized to 3,3'-dimethoxybenzidine

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding 3,3'-dimethoxybenzidine-(DMOB)based dyes metabolized to 3,3'-dimethoxybenzidine, 3,3'-dimethylbenzidine- (DMB)based dyes metabolized to 3,3'-dimethylbenzidine, ethylbenzene, propylene glycol mono-t-butyl ether, and thiouracil to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., Proposition 65). The listing of these chemicals is effective June 11, 2004. Toxicological Endpoint: Cancer

NTP Information Cited

National Toxicology Program (NTP). 2004. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Propylene Glycol Mono-t-Butyl Ether (CASRN 57018-52-7) in F344/N Rats and B6C3F1 Mice and a Toxicology Study of Propylene Glycol Mono-t-Butyl Ether (CASRN 57018-52-7) in Male NBR Rats (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 515. https://ntp.niehs.nih.gov/go/tr515abs

NTP (National Toxicology Program). 2002. 3,3′-Dimethylbenzidine and Dyes Metabolized to 3,3′-Dimethylbenzidine. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/dimethylbenzidineanddyes.pdf

NTP (National Toxicology Program). 2002. 3,3′-Dimethoxybenzidine and Dyes Metabolized to 3,3′-Dimethoxybenzidine. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/dimethoxybenzidineanddyes.pdf

  • Type: Notice
  • June 11, 2004
  • Proposition 65
57018-52-7
2004 FDA
Furan in Food, Thermal Treatment; Request for Data and Information

The FDA is requesting the submission of data and information on furan, a heat treatment related byproduct that has been detected in certain thermally treated foods.

NTP Information Cited
National Toxicology Program (NTP). 1993. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furan (CASRN 110-00-9) in F344/N Rats and B6C3F1 Mice(Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 402. https://ntp.niehs.nih.gov/go/tr402abs

  • Type: Notice
  • May 10, 2004
  • 69 FR 25911
110-00-9
2004 OEHHA
Chemical Listed Effective May 7, 2004 as known to the State of California to Cause Cancer: Nickel Compounds

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding nickel compounds to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5, Proposition 65). The listing of nickel compounds is effective May 7, 2004. Toxicological Endpoint: Cancer

NTP Information Cited
NTP (National Toxicology Program). 2002. Nickel Compounds and Metallic Nickel. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nickel.pdf

  • Type: Notice
  • May 07, 2004
  • Proposition 65
Nickel compounds
2004 OEHHA
Announcement of Publication of the Final Public Health Goal for Arsenic in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final Public Health Goal (PHG) for arsenic.

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Roxarsone (CASRN 121-19-7) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 345. https://ntp.niehs.nih.gov/go/tr345abs

  • Type: Notice
  • April 23, 2004
  • Public Health Goals
121-19-7
2004 EPA
National Emission Standards for Hazardous Air Pollutants: Proposed Standards for Hazardous Air Pollutants for Hazardous Waste Combustors

The EPA proposes national emission standards for hazardous air pollutants (HAPs) for hazardous waste combustors (HWCs). These proposed standards will, when final, implement section 112(d) of the Clean Air Act by requiring HWCs to meet HAP emission standards reflecting the application of the maximum achievable control technology.

NTP Information Cited
National Toxicology Program (NTP). 1996. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Nickel Oxide (CASRN 1313-99-1) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 451. https://ntp.niehs.nih.gov/go/tr451abs

National Toxicology Program (NTP). 1996. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Nickel Subsulfide (CASRN 12035-72-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 453. https://ntp.niehs.nih.gov/go/tr453abs

National Toxicology Program (NTP). 1996. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Nickel Sulfate Hexahydrate (CASRN 10101-97-0) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 454. https://ntp.niehs.nih.gov/go/tr454abs

NTP (National Toxicology Program). 2002. Nickel Compounds and Metallic Nickel. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/nickel.pdf

NTP (National Toxicology Program). 2000. 2,3,7,8-Tetrachlorodibenzo-p-dioxin. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/tetrachlorodibenzodioxin.pdf

  • Type: Proposed
  • April 20, 2004
  • 69 FR 21198
1313-99-1
12035-72-2
10101-97-0
1746-01-6
2004 FDA
Final Rule Declaring DietarySupplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk

Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk

NTP Information Cited
National Toxicology Program (NTP). 1986. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Ephedrine Sulfate (CASRN 134-72-5) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 307. https://ntp.niehs.nih.gov/go/tr307abs

  • Type: Final Rule
  • February 11, 2004
  • 69 FR 6787
134-72-5
2004 EPA
Fifty-Third Report of the TSCAInteragency Testing Committee to theAdministrator of the EnvironmentalProtection Agency; Receipt of Reportand Request for Comments

The Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) transmitted its Fifty-Third Report to the Administrator of the EPA on December 2, 2003 revising the Priority Testing List by adding 3 pyridinamines and 20 tungsten compounds requesting that EPA add the 3 pyridinamines and 20 tungsten compounds to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule and soliciting voluntary use, exposure, and effects information for 3 pyridinamines, 20 tungsten compounds, and 43 vanadium compounds through its Voluntary Information Submissions Innovative Online Network.

NTP Information Cited
National Toxicology Program (NTP). 2009. NTP Report on Carcinogens Background Document for Cobalt–Tungsten Carbide: Powders and Hard Metals. Research Triangle Park, NC: National Toxicology Program. https://ntp.niehs.nih.gov/ntp/roc/twelfth/2010/finalbds/hardmetalsbd20100408_508.pdf

  • Type: Notice
  • January 15, 2004
  • 69 FR 2468
1314-35-8
2003 EPA
List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List

The EPA proposes to amend the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing ethylene glycol monobutyl ether from the group of glycol ethers.

NTP Information Cited
National Toxicology Program (NTP). 2000. NTP Technical Report on the Toxicology and Carcinogenesis Studies of 2-Butoxyethanol (CASRN 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 484. https://ntp.niehs.nih.gov/go/tr484abs

  • Type: Proposed
  • November 21, 2003
  • 68 FR 65648
111-76-2
2003 OEHHA
Chemical Listed Effective November 14, 2003 as Known to the State of California to Cause Cancer: Fumonisin B1

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding fumonisin B1 to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of fumonisin B1 is effective November 14, 2003 Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP). 2001. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Fumonisin B1 (CASRN 116355-83-0) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 496. https://ntp.niehs.nih.gov/go/tr496abs

  • Type: Notice
  • November 14, 2003
  • Proposition 65
116355-83-0
2003 FDA
International Conference on Harmonisation; Final Recommendations on the Revision of the Permitted Daily Exposures for Two Solvents, N-Methylpyrrolidone and Tetrahydrofuran, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; Availability

The Food and Drug Administration (FDA) is announcing final recommendations to revise the permitted daily exposures (PDEs) for two solvents, n-methylpyrrolidone (NMP) and tetrahydrofuran (THF), according to the maintenance procedures for the guidance for industry entitled “Q3C Impurities: Residual Solvents.” The final recommendations were reached under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

NTP Information Cited
National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of Stannous Chloride (CASRN 7772-99-8) in F344/N Rats and B6C3F1/N Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 231. https://ntp.niehs.nih.gov/go/tr231abs

  • Type: Notice
  • November 13, 2003
  • 68 FR 64352
7772-99-8
2003 OEHHA
Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

NTP Information Cited
National Toxicology Program (NTP). 1983. Lifetime Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in Syrian Golden Hamsters (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 249. https://ntp.niehs.nih.gov/go/tr249abs

National Toxicology Program (NTP). 1985. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in F344/N Rats (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 295. https://ntp.niehs.nih.gov/go/tr295abs

National Toxicology Program (NTP). 1988. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Crocidolite Asbestos (CASRN 12001-28-4) in F344/N Rats (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 280. https://ntp.niehs.nih.gov/go/tr280abs

National Toxicology Program (NTP). 1990a. Lifetime Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in Syrian Golden Hamsters (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 246. https://ntp.niehs.nih.gov/go/tr246abs

National Toxicology Program (NTP). 1990b. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in F344/N Rats (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 279. https://ntp.niehs.nih.gov/go/tr279abs

National Toxicology Program (NTP). 1990c. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Tremolite (CASRN 14567-73-8) in F344/N Rats (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 277. https://ntp.niehs.nih.gov/go/tr277abs

NTP (National Toxicology Program). 2000. Asbestos. Report on Carcinogens. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf

National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of Di(2-ethylhexyl)adipate (CASRN 103-23-1) in F344 Rats and B6C3F1 Mice (Feed Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 212. https://ntp.niehs.nih.gov/go/tr212abs

National Toxicology Program (NTP). 1985. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Chlorobenzene (CASRN 108-90-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 261. https://ntp.niehs.nih.gov/go/tr261abs

National Toxicology Program (NTP). 1982. Carcinogenesis Bioassay of 1,2-Dibromoethane (CASRN 106-93-4) in F344 Rats and B6C3F1 Mice (Inhalation Study). Research Triangle Park, NC: National Toxicology Program. Technical Report 210. https://ntp.niehs.nih.gov/go/tr210abs

National Toxicology Program (NTP). 1994. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Barium Chloride Dihydrate (CASRN 10326-27-9) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 432. https://ntp.niehs.nih.gov/go/tr432abs

  • Type: Notice
  • September 26, 2003
  • Public Health Goals
12172-73-5
12001-29-5
12001-28-4
12001-29-5
12172-73-5 14567-73-8
1332-21-4
103-23-1
108-90-7
106-93-4
10326-27-9
2003 EPA
National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule

The EPA is proposing maximum contaminant level goals (MCLGs) for chloroform, monochloroacetic acid and trichloroacetic acid;National Primary Drinking Water Regulations for total trihalomethanes and haloacetic acids; and revisions to the reduced monitoring requirements for bromates.

NTP Information Cited
National Toxicology Program (NTP). 1987. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Bromodichloromethane (CASRN 75-27-4) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 321. https://ntp.niehs.nih.gov/go/tr321abs

National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Tribromomethane (Bromoform) (CASRN 75-25-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 350. https://ntp.niehs.nih.gov/go/tr350abs

National Toxicology Program (NTP). 1992. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Monochloroacetic Acid (CASRN 79-11-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 396. https://ntp.niehs.nih.gov/go/tr396abs

  • Type: Notice
  • August 18, 2003
  • 68 FR 49548
79-11-8
75-25-2
75-27-4
2003 OEHHA
Chemical Listed Effective March 14, 2003 as Known to the State of California to Cause Cancer: Strong Inorganic Acid Mists Containing Sulfuric Acid

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding strong inorganic acid mists containing sulfuric acid to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of strong inorganic acid mists containing sulfuric acid is effective March 14, 2003. Toxicological Endpoint: Cancer

NTP Information Cited
NTP (National Toxicology Program). 2000. Report on Carcinogens, Ninth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. https://ntp.niehs.nih.gov/go/roc

  • Type: Notice
  • March 14, 2003
  • Proposition 65
7664-93-9 (Mists containing)
2003 FDA
New Animal Drugs: Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition

The FDA is prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. The extralabel use presents a risk to the public health.

NTP Information Cited
National Toxicology Program (NTP). 1990. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Phenylbutazone (CASRN 50-33-9) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 367. https://ntp.niehs.nih.gov/go/tr367abs

  • Type: Final Rule
  • February 28, 2003
  • 68 FR 9528
50-33-9
2002 EPA
Sucrose Octanoate Esters; Exemption from the Requirement of a Tolerance

The EPA has established an exemption from the tolerance requirements pursuant to FFDCA 408(c) and 9(d) for residues of certain Sucrose Octanoate Esters (SOEs) in or on all food commodities when applied/used in accordance with good agricultural practices.

NTP Information Cited
The EPA has determined, based on available toxicology data including data from an NTP genetic toxicology study, that no harm will result from aggregate exposure of residues of SOEs to the U.S. population.

  • Type: Notice
  • September 25, 2002
  • 67 FR 60146
124-07-2
2002 EPA
Indirect Food Additives: Polymers

The EPA is soliciting public comment on whether a preliminary determination that nine contaminants do not meet all three Safe Drinking Water Act requirements is appropriate, and thus no National Primary Drinking Water Regulations (NPDWR) should be considered for these contaminants.

NTP Information Cited
The EPA used data from the NTP Toxicity Studies of Hexachloro-1,3-butadiene, (TOX- 1) and Naphthalene (TR-410) & (TR-500) in determining that NPDWRs should not be considered for these contaminants.

  • Type: Notice
  • June 03, 2002
  • 67 FR 38222
91-20-3
87-68-3
2002 OEHHA
Chemical Listed Effective May 17, 2002 as Known to the State of California to Cause Cancer: Pyridine

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding pyridine to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of pyridine is effective May 17, 2002. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 470. NIH Publication No. 97-3960.

  • Type: Notice
  • May 17, 2002
  • Proposition 65
110-86-1
2002 EPA
Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

EPA announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

NTP Information Cited
National Toxicology Program (NTP). 1990. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Fluoride (CASRN 7681-49-4) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 393. https://ntp.niehs.nih.gov/go/tox393abs

  • Type: Notice
  • April 24, 2002
  • 61 FR 20121
7681-49-4
2002 OEHHA
Chemical Listed Effective April 19, 2002 as Known to the State of California to Cause Cancer: Naphthalene

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding naphthalene to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of naphthalene is effective April 19, 2002. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). NTP Technical Report Series No. 500. NIH Publication No. 01-4434.

  • Type: Notice
  • April 19, 2002
  • Proposition 65
91-20-3
2002 EPA
Indirect Food Additives: Polymers

EPA intends to reclassify eight inert ingredients from List 2, Potentially Toxic Inerts/High Priority for Testing to List 1 Inerts of Toxicological Concern. One of the criteria for being considered a List 1 inert ingredient is to be characterized by the NTP as an animal carcinogen in at least one species and sex.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of 2-Benzyl-4-chlorophenol (TR-424), 2-Butoxyethanol (TR-484), Butyl benzyl Phthalate (TRs 213 & 458), Diethanolamine (TR-478), Ethylbenzene (TR-466), 1,2-Epoxybutane (TR-329), 2-Mercaptobenzothiazole (TR-332), and Nitromethane (TR-461) to support its reclassification of these inert ingredients to List 1. (TR-444)

  • Type: Final Rule
  • March 08, 2002
  • 67 FR 10718
100-41-4
106-88-7
149-30-4
120-32-1
85-68-7 111-42-2
75-52-5
111-76-2
2002 EPA
Diflubenzuron; Pesticide Tolerance

This regulation establishes a tolerance for combined residues of diflubenzuron and its metabolites 4-chloroaniline and 4-chlorophenylurea in or on pear. IR-4 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

NTP Information Cited
National Toxicology Program (NTP). 1989. NTP Technical Report on the Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CASRN 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 351. https://ntp.niehs.nih.gov/go/tr351abs

  • Type: Final Rule
  • February 15, 2002
  • 67 FR 7085
20265-96-7
2001 OEHHA
Chemical Listed Effective November 16, 2001 as Known to the State of California to Cause Cancer: Methyleugenol

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding the chemical methyleugenol to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemical is listed effective November 16, 2001. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies ofMethyleugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 491 NIH Publication No. 00-3950.

  • Type: Notice
  • November 16, 2001
  • Proposition 65
93-15-2
2001 EPA
National Advisory Committee for Acute Exposure Guidelines Levels (AEGLs) for Hazardous Substances; Proposed AEGL Values.

The EPA is proposing AEGLs for 18 chemicals to provide Federal, State, and local agencies with threshold short-term exposure limits for the public to hazardous, airborne chemicals.

NTP Information Cited
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Tetrachloroethylene (TR-311) and Tetranitromethane (TR-386) in determining the proposed AEGL values for these two chemicals.

  • Type: Final Rule
  • May 02, 2001
  • 66 FR 21940
509-14-8
127-18-4
2001 OEHHA
Chemicals Delisted Effective April 6, 2001 as Known to the State to Cause Cancer

The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). As the lead agency, OEHHA is removing saccharin from the list of chemicals known to the state to cause cancer, for purposes of Proposition 65. Saccharin [CAS No. 81-07-2] was originally added to the Proposition 65 list on October 1, 1989. This chemical was added to the Proposition 65 list as a result of the issuance of a judicial decision enforcing Labor Code Section 6382(b)(1) and (d) which are incorporated by reference as Proposition 65 listing provisions pursuant to Health and Safety Code Section 25249.8(b). Labor Code Section 6382(b)(1) requires inclusion of substances listed as human or animal carcinogens by the International Agency for Research on Cancer (IARC). Labor Code Section 6382(d) requires the inclusion of chemicals identified as carcinogens or potential carcinogens by IARC or the National Toxicology Program (NTP). Saccharin was identified by IARC and NTP as causing cancer.

NTP Information Cited
In 2000, NTP released its Ninth Report on Carcinogens in which it delisted saccharin [CAS No. 81 07-2] from the list of substances reasonably anticipated to be a human carcinogen. 

National Toxicology Program (NTP, 2000). Report on Carcinogens, Ninth Edition: Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, NC.

  • Type: Notice
  • April 06, 2001
  • Proposition 65
81-07-2
2001 OEHHA
Chemicals Listed Effective February 23, 2001 as Known to the State to Cause Cancer or Reproductive Toxicity: 13 chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding thirteen chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective February 27, 2001. Ethoprop, indium phosphide, lynestrenol, norethynodrel, and propachlor are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer.

NTP Information Cited
National Toxicology Program (NTP). 2000a. Toxicology and Carcinogenesis Studies of Indium Phosphide (CASRN 22398-80-7) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 499. https://ntp.niehs.nih.gov/go/tr499abs

  • Type: Notice
  • February 23, 2001
  • Proposition 65
22398-80-7
2001 MSHA
Diesel Particulate Matter Exposure of Underground Coal Miners

The Department of Labor is establishing new health standards for underground coal mines that use equipment powered by diesel engines. High concentrations of diesel particulate matter (DPM) increases the risk of serious health hazards in underground mines.

NTP Information Cited
The NTP is listed as one of many scientific organizations and governmental agencies that has reviewed the available epidemiologic and toxicological evidence for carcinogenicity and has identified dpm as a probable human carcinogen. (9th Report on Carcinogens)

  • Type: Final Rule
  • January 19, 2001
  • 66 FR 5525
2001 EPA
Control of Air Pollution from New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards and Highway Diesel Fuel Sulfur Control Requirements.

The EPA is setting new diesel exhaust emission standards for heavy-duty highway engines to protect the public's health. Health studies indicate potential hazards that appear to be related to acute and chronic exposure.

NTP Information Cited
The EPA cited the NTP as an example of a governmental agency that has identified diesel exhaust particles as reasonably anticipated to be a human carcinogen.(Ninth Report on Carcinogens).

  • Type: Final Rule
  • January 18, 2001
  • 66 FR 5002
2001 EPA
Lead and Lead Compounds: Lowering of Reporting Thresholds

The EPA is lowering the reporting thresholds for lead and lead compounds which are subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act and section 6607 of the Pollution Prevention Act.

NTP Information Cited
Commenters contended that the Persistent Bioaccumulative Toxic Chemicals (PBT) rule framework was designed only for organic substances and is being incorrectly applied to metals. The EPA disagreed citing, as an example, the NTP's criteria for characterizing chemical carcinogens is the same for organic as well as inorganic substances to support its position that it is scientifically valid to establish generic criteria that are applicable to all substances. (8th Report on Carcinogens)

  • Type: Final Rule
  • January 17, 2001
  • 66 FR 4500
2000 OEHHA
Chemicals Listed Effective December 22, 2000 as Known to the State of California to Cause Cancer or Reproductive Toxicity: Bromoethane, and 4 others

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding five chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective December 22, 2000. Bromoethane and isoxaflutole are listed pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemicals cause cancer.

NTP Information Cited
National Toxicology Program (NTP, 1989). Toxicology and Carcinogenesis Studies of Bromoethane (Ethyl Bromide) (CAS No. 74-96-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 363 NTIS Publication No. 90-2818.

  • Type: Notice
  • December 22, 2000
  • Proposition 65
74-96-4
2000 FDA
Vinclozolin; Pesticide Tolerances

The FDA is amending the food additive regulations to provide for the safe use of hydrogenated butadiene/acrylonitrile copolymers intended for contact with food in repeated use applications. Although the additive itself has not been shown to cause cancer, it has been found to contain residual amounts of acrylonitrile and butadiene, carcinogenic impurities resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of 1,3-Butadiene, (TR-434), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to butadiene would result from the proposed use of the additive.

  • Type: Final Rule
  • November 15, 2000
  • 65 FR 68888
106-99-0
2000 OSHA
Occupational Exposure to 4,4'Methylenedianiline (MDA)

OSHA is promulgating new standards regulating exposure to MDA.

NTP Information Cited
The Committee determined that the tumors found in the NTP study did not result from exposure to MDA. (TR-248)

  • Type: Final Rule
  • August 10, 2000
  • 57 FR 35630
13552-44-8
2000 EPA
Vinclozolin; Pesticide Tolerances

The EPA has established tolerances for combined residues of vinclozolin and its metabolites containing the 3,5-dichloroaniline moiety in or on specific raw agricultural commodities.

NTP Information Cited
The EPA used data from the NTP's p-Chloroaniline bioassay (TR-351) to help assess the carcinogenicity for structurally related chloroanilines.

  • Type: Final Rule
  • July 18, 2000
  • 65 FR 44453
20265-96-7
2000 OEHHA
Chemicals Listed Effective June 2, 2000 as Known to the State to Cause Cancer: Chloroprene, Cobalt sulfate heptahydrate, and Fenoxycarb

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer.

NTP Information Cited
National Toxicology Program (NTP). 1998a. Toxicology and Carcinogenesis Studies of Chloroprene (CASRN 126-99-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 467. https://ntp.niehs.nih.gov/go/tr467abs

  • Type: Notice
  • June 22, 2000
  • Proposition 65
126-99-8
2000 OEHHA
Chemicals Listed Effective June 2, 2000 as Known to the State to Cause Cancer: Chloroprene, Cobalt sulfate heptahydrate, and Fenoxycarb

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding three chemicals to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The chemicals are listed effective June 2, 2000 pursuant to an administrative listing mechanism provided under Proposition 65, based upon a formal identification by an authoritative body that the chemical causes cancer.

NTP Information Cited
National Toxicology Program (NTP, 1996). Toxicology and Carcinogenesis Studies of Isobutyl Nitrite (CAS No.542-56-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 448.

  • Type: Notice
  • June 22, 2000
  • Proposition 65
10026-24-1
2000 EPA
Diflubenzuron; Pesticide Tolerances

The EPA has received a pesticide petition for establishing a tolerance for residues of diflubenzuron in or on the raw agricultural commodity rangeland grass at 6.0 ppm. P-Chloroaniline (PCA) is a metabolite of diflubenzuron.

NTP Information Cited
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to determine that the dietary risk from diflubenzuron-derived PCA is below EPA's level of concern.

  • Type: Notice
  • April 05, 2000
  • 65 FR 17872
20265-96-7
2000 OSHA
Air Contaminants

OSHA notice providing index to Jan. 19, 1989 final rule and list of references relied upon for health effects evaluations in rule.

NTP Information Cited
NTP references cited include TR-306, TR-228, TR-263, TR-273, ;TR-311, TR-259, TR-251.

  • Type: Final Rule
  • March 28, 2000
  • 54 FR 12792
78-87-5
127-18-4
140-88-5
26471-62-5
75-09-2 75-35-4
79-01-6
2000 EPA
Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food.

The FDA is amending the food additive regulations to provide for the safe use of ethylene-norbornene copolymers as articles or components of articles in contact with dry food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of benzene, a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of Benzene (TR-289), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to benzene would result from the proposed use of the additive.

  • Type: Final Rule
  • January 21, 2000
  • 65 FR 3384
71-43-2
2000 EPA
1,3-Dichloropropene: Proposed Determination to Terminate Special Review

The EPA proposed to terminate the Special Review of 1,3-Dichloropropene (1,3-D). The EPA has determined that the benefits associated with the continued use of 1,3-D under the recently revised terms and conditions of 1,3-D's reregistration outweigh the risks.

NTP Information Cited
The EPA classified 1,3-D as a probable, human carcinogen based on the review of data from carcinogenicity studies including the NTP Toxicology and Carcinogenesis Studies of Telone II (TR-269).

  • Type: Final Rule
  • January 12, 2000
  • 65 FR 1869
542-75-6
1999 FDA
Diflubenzuron; Pesticide Tolerances

The FDA is amending the food additive regulations to provide for the safe use of 4,5-dichloro-1,2-dithiol-3-one as a slimicide in the manufacture of food-contact paper and paperboard. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of tetrachloroethylene, a carcinogenic impurity resulting from the manufacture of the additive

NTP Information Cited
The FDA used data from the NTP Carcinogenicity Study of Tetrachloroethylene (TR-311), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to tetrachloroethylene would result from the proposed use of the additive.

  • Type: Final Rule
  • December 15, 1999
  • 64 FR 69898
127-18-4
1999 EPA
Diflubenzuron; Pesticide Tolerances

The EPA established tolerances for residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in/on rice grain at 0.02 ppm and rice straw at 0.8 ppm.

NTP Information Cited
The 4-chloroaniline (PCA) metabolite was classified as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP bioassay on PCA (TR-351). The NTP bioassay and the results of several NTP mutagenicity studies on PCA discussed in the bioassay report were part of the information used to estimate dietary risk assessments.

  • Type: Final Rule
  • April 19, 1999
  • 64 FR 19050
20265-96-7
1999 EPA
Acetonitrile: Community Right-to-Know Toxic Chemical Release Reporting

The EPA is denying a petition to remove acetonitrile from the list of chemicals subject to the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA).

NTP Information Cited
EPA reviewed all of the available data, including the NTP Technical Report of the Toxicology and Carcinogenesis of Acetonitrile (TR-447), to conclude that acetonitrile can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, including neurotoxicity and death.

  • Type: Notice
  • March 05, 1999
  • 64 FR 10597
75-05-8
1999 FDA
Diflubenzuron; Pesticide Tolerances

The FDA is issuing a final rule establishing that the over-the-counter stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded.

NTP Information Cited
After reviewing all of the available data, including the NTP phenolphthalein studies, the FDA concluded that phenolphthalein caused chromosome aberrations, cell transformation, and mutagenicity in mammalian cells and is reasonably anticipated to have human carcinogenic potential. TR 465: Toxicology and Carcinogenesis Studies of Phenolphthalein in F344/N Rats and B6C3F1 Mice (Feed Studies) Dunnick JK et al.,; Phenolphthalein Induces Thymic Lymphomas Accompanied By Loss Of The P53 Wild Type Allele In Heterozygous P53-Deficient (+/-) Mice,; Toxicologic Pathology 1997, 25(6): 533-540.

  • Type: Final Rule
  • January 29, 1999
  • 64 FR 4535
1999 EPA
Update on the Status of the Superfund Substance-Specific Applied Research Program

This Notice provides the status of ATSDR's Superfund mandated Substance-Specific Applied Research Program (SSARP). To date, 188 priority data needs have been identified for the 50 priority hazardous substances frequently found at waste sites.

NTP Information Cited
The ATSDR maintains an interagency agreement (IAG) with NTP to conduct toxicologic testing of substances identified at National Priority List sites.  Under this agreement, the NTP filled the toxicity priority data need for the immunotoxicology study of carbon tetrachloride.  The NTP is currently addressing reproductive toxicity data needs for chlordane, endrin, and heptachor; the bioavailability of PCB's in soil; and dose-response data for di-n-butyl phthalate.

  • Type: Notice
  • January 15, 1999
  • 64 FR 2759
1998 FDA
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

The FDA is amending the food additive regulations to provide for the safe use of 2,9-dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. Pigment Red 202) as a colorant for polymers used in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of para-chloroaniline, a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP carcinogenicity study of para-Chloroaniline Hydrochloride (TR-351) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed  use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to para-chloroaniline would result from the proposed use of the additive

  • Type: Final Rule
  • November 03, 1998
  • 63 FR 59213
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
88-72-2
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
612-83-9
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
21739-91-3
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
598-55-0
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
77-09-8
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 351.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
20265-96-7
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
389-08-2
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1982a). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
842-07-9
1998 OEHHA
Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373.

  • Type: Notice
  • May 15, 1998
  • Proposition 65
599-79-1
1998 EPA
Diflubenzuron; Temporary Pesticide Tolerance

This regulation establishes a temporary tolerance for residues of the insecticide diflubenzuron and metabolites convertible to p-chloroaniline (PCA) expressed as diflubenzuron on rice grain at 0.01 ppm.

NTP Information Cited
PCA was classified as a Group B2 carcinogen (probable human carcinogen). The classification for PCA was based on the results of the NTP bioassay on p-chloroaniline hydrochloride (TR-351). The results of several NTP mutagenicity studies on PCA discussed in the bioassay report were also cited.

  • Type: Final Rule
  • May 13, 1998
  • 63 FR 26481
20265-96-7
1998 EPA
Organobromine Production Wastes; Identification and Listing of Hazardous Waste; Land Disposal Restrictions; Listing of CERCLA Hazardous Substances, Reportable Quantities

EPA is adding tribromophenol and wastes generated from its production to its list of CERCLA hazardous substances. EPA used structure activity relationship (SAR) analysis information in support of its listing of tribromophenol.

NTP Information Cited
NTP mutagenicity studies are cited to show that a negative in Salmonella does not necessarily predict that 2,4,6-trichlorophenol is not a carcinogen. As part of its validation of the use of SAR analysis for identifying hazardous wastes, EPA cited a comparison of the NTP bioassay of 1,2-dibromoethane (TR-210) with the NCI bioassay of 1,2-dichloroethane (TR-55). The study results showed that carcinogenic activity was retained with the substitution of a chlorine by a bromine.

  • Type: Final Rule
  • May 04, 1998
  • 63 FR 24596
88-06-2
106-93-4
107-06-2
1997 FDA
Laxative Drug Products for Over-the-Counter Human Use: Proposed Amendment to the Tentative Final Monograph

As part of its ongoing review of OTC drug products, the FDA is proposing to amend the tentative final monograph for over-the-counter laxative drug products by reclassifying phenolphthalein from Category I (generally recognized as safe and effective) to Category II (not generally recognized as safe and effective).

NTP Information Cited
Based on the results of NTP studies, the FDA considers use of phenolphthalein a potential risk to humans. The NTP findings of rodent carcinogenicity and genotoxicity in several test systems indicate that chronic use of phenolphthalein could lead to damage to the human genome and could increase the risk of malignancy.

  • Type: Proposed Rule
  • September 02, 1997
  • 62 FR 46223
77-09-8
1997 OEHHA
Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (DrinkingWater Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852.

  • Type: Notice
  • August 15, 1997
  • Proposition 65
2429-74-5
1997 OEHHA
Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP). 1994a. Toxicology and Carcinogenesis Studies of 1-Amino-2,4-Dibromoanthraquinone (CASRN 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 383. https://ntp.niehs.nih.gov/go/tr383abs

  • Type: Notice
  • August 15, 1997
  • Proposition 65
81-49-2
1997 OEHHA
Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

NTP Information Cited
National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161.

  • Type: Notice
  • August 15, 1997
  • Proposition 65
28407-37-6
1997 OSHA
Supplement to California State Plan; Approval

OSHA approves, subject to certain conditions, the California Hazard Communication Standard, including Proposition 65 -- the California Safe Drinking Water and Toxic Enforcement Act.

NTP Information Cited
In accordance with Proposition 65, California annually publishes a list of chemicals known to cause cancer or reproductive toxicity. This list includes chemicals identified as carcinogens by IARC and the NTP.

  • Type: Notice
  • June 06, 1997
  • 62 FR 31159
N/A
1997 EPA
Addition of Dioxin and Dioxin-Like Compounds; Modification of Polychlorinated Biphenyls Listing; Toxic Chemical Release Reporting; Community Right-to-Know

The EPA is proposing to add a chemical category that includes dioxin and 27 dioxin-like compounds to the list of toxic chemicals subject to the reporting requirements under EPCRA.

NTP Information Cited
As part of the basis for this proposed rule, the EPA noted that the NTP bioassays of 1,2,3,6,7,8- and 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin (TR-198) showed that these compounds are carcinogenic. The EPA also noted that the NTP's Annual Report on Carcinogens listed PCBs as substances which may reasonably be anticipated to be human carcinogens.

  • Type: Proposed Rule
  • May 07, 1997
  • 62 FR 24887
1997 OEHHA
Chemicals Listed Effective May 1, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 9 chemicals

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer

NTP Information Cited

National Toxicology Program (NTP). 1995a. Toxicology and Carcinogenesis Studies of Nitromethane (CASRN 75-52-5) in F344 Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 461. https://ntp.niehs.nih.gov/go/tr461abs

National Toxicology Program (NTP). 1995b. Toxicology and Carcinogenesis Studies of Tetrafluoroethylene (CASRN 116-14-3) in F344 Rats and B6C3F1 Mice (Inhalation Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 450. https://ntp.niehs.nih.gov/go/tr450abs

  • Type: Notice
  • May 01, 1997
  • Proposition 65
75-52-5
116-14-3
1997 EPA
Indirect Food Additives: Adhesives and Components of Coatings; Adjuvants, Production Aids and Sanitizers

Final Rule: The FDA is amending the food additive regulations to provide for the safe use of 2,2-ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite as an antioxidant in adhesives and in the preparation of polymers intended for contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Inhalation Bioassay on Methylene Chloride, TR-306, to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive.

  • Type: Final Rule
  • January 15, 1997
  • 62 FR 2011
75-09-2
1997 EPA
Supplement to California State Plan; Approval

EPA is denying a petition to remove the barium compounds category from the list of chemicals subject to reporting requirements under the Community Right-to-Know Act and the Pollution Prevention Act. The EPA concluded that barium ion can become available from the barium compounds subject to the reporting, and that barium ion can reasonably be anticipated to cause chronic toxicity.

NTP Information Cited
The EPA's toxicological evaluation of barium compounds included review of data from the NTP's Drinking Water Toxicity/Carcinogenicity Studies of Barium Chloride Dihydrate (TR-432).

  • Type: Proposed Rule
  • January 03, 1997
  • 62 FR 366
10326-27-9
1996 FDA
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

Final Rule: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of 1,2-benzisothiazolin-3-one as a biocide in rubber latex for use in the manufacture of rubber articles intended for repeated use in contact with food. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) and dibenzo-p-dioxins impurities resulting from the manufacturing process.

NTP Information Cited
An independent pathology review reanalyzed slides of the liver tumors observed in a bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk.

  • Type: Final Rule
  • November 29, 1996
  • 61 FR 231
1996 EPA
Guidelines for Reproduction Toxicity Risk Assessment

Notice: The EPA has made available the final Guidelines for Reproductive Toxicity Risk Assessment. The Guidelines include protocols designed to determine the potential of a test substance to produce reproductive toxicity in laboratory animals.

NTP Information Cited
NTP Work Cited: An NTP continuous breeding protocol, Fertility Assessment by Continuous Breeding, is cited as an example of alternative reproductive tests which the EPA considered in developing the Guidelines.

  • Type: Notice
  • October 31, 1996
  • 61 FR 56274
1996 EPA
Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra

The EPA is promulgating a new use rule which requires persons to notify the EPA at least 90 days before commencing the manufacture, import, or processing of certain (22) benzidine-based chemical substances for significant new use as described in this rule.

NTP Information Cited
As part of the basis for this significant new use rule, EPA noted that NIOSH and NCI jointly recommended that three benzidine-based dyes, Direct Black 38, Direct Blue 6, and Direct Brown 95, be handled in the workplace as if they were human carcinogens. This recommendation was based on testing data including the NTP/NCI bioassay which confirmed that these dyes cause cancer in rodents. (TR-108)

  • Type: Final Rule
  • October 07, 1996
  • 61 FR 52287
16071-86-6
2602-46-2
1937-37-7
1996 FDA
Indirect Food Additives: Polymers

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a copolymer of ethyl acrylate, methyl methacrylate, and methacrylamide in combination with melamine-formaldehyde resin as a coating for polyethylene phthalate films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of unreacted ethyl acrylate, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used the data from the NTP Bioassay on Ethyl Acrylate (TR-259) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to ethyl acrylate would result from the proposed use of the additive.

  • Type: Final Rule
  • September 05, 1996
  • 61 FR 46719
140-88-5
1996 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of phosphorylated tall oil fatty acids as pigment dispersants in polymeric films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of dimethyl hydrogen phosphite, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used the data from the NTP Bioassay on Dimethyl Hydrogen Phosphite (TR-287) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive.  And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to dimethyl hydrogen phosphite would result from the proposed use of the additive.

  • Type: Final Rule
  • August 21, 1996
  • 61 FR 43156
1996 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polyaryletherketone resins as a basic resin for use in food-contact materials. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

NTP Information Cited
The FDA used data from the NTP Bioassay on Methylene Chloride (TR-306) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive.

  • Type: Final Rule
  • August 15, 1996
  • 61 FR 42379
75-09-2
1996 EPA
Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra

EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act to require manufacturers and processors of 21 hazardous air pollutants (HAPs) to test these substances for certain health effects.

NTP Information Cited
As part of the process to select which study data were needed for these HAPs, EPA reviewed the NTP's database of ongoing testing to locate unpublished studies.

  • Type: Proposed Rule
  • June 26, 1996
  • 61 FR 33178
1996 EPA
Proposed Guidelines for Carcinogen Risk Assessment

The EPA announced the publication of the new "Proposed Guidelines for Carcinogen Risk Assessment" which replaces the 1986 guidelines.

NTP Information Cited
Default assumptions are recognized as necessary in risk assessment ( National Research Council report) and the EPA has incorporated into its risk assessment guidelines default assumptions in part using inferences based on general scientific knowledge. The studies and experience of the NTP are cited and referred to throughout this Federal Register notice as part of the scientific knowledge used by the EPA to develop their defaults and how they plan their assessment of evidence of toxicity.

  • Type: Notice
  • April 23, 1996
  • 61 FR 17960
1996 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra

The FDA is amending the food additive regulations to provide for the safe use of sucrose esterified with medium and long chain fatty acids (olestra) as a replacement for fats and oils.

NTP Information Cited
The FDA used data from the NTP historical pathology database to support its rationale that there was no association between treatment with olestra and the incidence of leukemia developed by male rats during a 2-year carcinogenicity study.

  • Type: Final Rule
  • January 30, 1996
  • 61 FR 3117
1995 EPA
Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel

EPA's issued this Notice to inform the public that the Agency has, after reviewing additional study date, reassessed the potential adverse effects and the benefits associated with the use of pesticide products containing dichlorvos. The Agency has preliminarily determined that, unless the terms and conditions of registration are modified as proposed in this Notice, the risks from the use of dichlorvos outweigh the benefits of their continued use.

NTP Information Cited
National Toxicology Program (NTP). 1989. Toxicology and Carcinogenesis Studies of Dichlorvos (CASRN 62-73-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. Technical Report 342. https://ntp.niehs.nih.gov/go/tr342abs

  • Type: Notice
  • September 28, 1995
  • 60 FR 50337
62-73-7
1995 EPA
Diethyl Phthalate; Toxic Chemical Release Reporting: Community Right-to-Know

EPA is proposing to delete diethyl phthalate (DEP) from the list of chemicals subject to reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited
As part of the relevant data, EPA used results of the NTP dermal bioassay to conclude that there is insufficient evidence to establish that DEP is likely to cause cancer. TR-429.

  • Type: Proposed Rule
  • September 05, 1995
  • 60 FR 46076
84-66-2
1995 EPA
Benzidine-Based Chemical Substances; Proposed Significant New Uses of Certain Chemical Substances

The EPA is proposing a significant new use rule under section 5(a)(2) of TSCA which would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of benzidine-based chemical substances. The EPA believes that benzidine-based chemical substances may be hazardous to human health and that the proposed rule will protect against potentially adverse exposure.

NTP Information Cited
EPA supported, in part, their conclusion about the potential hazard of benzidine-based chemical substances on the results of three benzidine-based dye rodent studies reported by the NTP. TR-108.

  • Type: Final Rule
  • August 30, 1995
  • 60 FR 45119
16071-86-6
2602-46-2
1937-37-7
1995 EPA
Thirty-Sixth Report of the TSCA ITC; Revision of Priority Testing List

The ITC is revising its Priority Testing List including the removal of butyraldehyde; sulfonyl bis(4-chlorobenzene); 2-propenoic acid,2-cyanoethyl ester; and dipropylene glycol from the List as a result of NTP testing.

NTP Information Cited
The NTP has sponsored a reproductive screening test of butyraldehyde; has developed most of the screening test data and will be conducting health effects testing for sulfonyl bis(4-chlorobenzene); is currently testing a dipropylene glycol mixture; and is evaluating the practical problems which may prevent effective health effects testing of ethyl cyanoacrylate.

  • Type: Notice
  • August 17, 1995
  • 60 FR 42981
123-72-8
25265-71-8
80-07-9
7085-85-0
1995 EPA

Proposal to delist di-(2-ethylhexyl) adipate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of1990

NTP Information Cited
As part of the relevant data, EPA used results of the NTP bioassay to conclude that, overall, the evidence is too limited to establish that di-(2-ethylhexyl) adipate is likely to cause cancer. TR 212.

  • Type: Proposed
  • August 01, 1995
  • 60 FR 39132
103-23-1
1995 EPA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium

The EPA proposes to establish a tolerance for residues of the insecticide dimethoate in or on the raw agricultural commodities blueberries and asparagus (see Federal Register July 5, 1995, p. 34945)

NTP Information Cited
The NTP has concluded that dimethoate is a "mutagenic" compound based on its testing for gene mutation and chromosomal aberrations.

  • Type: Proposed Rule
  • June 23, 1995
  • 60 FR 32640
60-51-5
1995 EPA
Reportable Quantity Adjustments

The EPA has taken final action on reportable quantities (RQs) for hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act. The person in charge of a facility or vessel from which a hazardous substance is released in excess of its RQs must notify appropriate authorities, who can then evaluate whether a response is needed.

NTP Information Cited
The Agency has promulgated a final RQ of 100 pounds (as proposed) based on chronic toxicity. Because no chronic toxicity studies have been reported for diethanolamine, both EPA and commenters used data from a NTP 13-week subchronic study (TOX-20) to develop their respective conclusions.

  • Type: Final Rule
  • June 12, 1995
  • 60 FR 30926
111-42-2
1995 EPA
Diflubenzuron: Pesticide Tolerances

The EPA established tolerances for residues of the insecticide diflubenzuron in or on raw agricultural commodities. Para-chloroaniline (PCA) is a metabolite of diflubenzuron.

NTP Information Cited
Information from the NTP bioassay on PCA was used to help establish maximum permissible levels (TR-351).

  • Type: Final Rule
  • May 10, 1995
  • 60 FR 24785
20265-96-7
1995 EPA
Monosodium Methanearsonate and Disodium Methanearsonate: Toxic Chemical Release Reporting; Community Right-to-Know

EPA is denying a petition to delist monosodium methanearsonate and disodium methanearsonate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986.

NTP Information Cited
The EPA and the NTP have classified inorganic arsenicals, including arsenate, as known human carcinogens. (NTP 7th Annual Report on Carcinogens)

  • Type: Other
  • April 20, 1995
  • 60 FR 19702
1995 EPA
Test Rule; Office of Water Chemicals Proposed Withdrawal of Certain Testing Requirements

The EPA is proposing to withdraw certain testing requirements for two chemical substances listed in the Office of Water chemicals test rule. This proposal includes the withdrawal of the 90-day subchronic testing requirements for 1,1,2,2-tetrachloroethane.

NTP Information Cited
The NTP's 90-day subchronic toxicity drinking water study of 1,1,2,2-tetrachloroethane meets the 90-day subchronic toxicity test required under the test rule and can be used to establish long-term Health Advisories for the Office of Water. (TOX-45)

  • Type: Proposed Rule
  • April 10, 1995
  • 60 FR 18079
79-34-5
1995 FDA
Gastroenterology-Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device

The FDA is proposing to require the filing of a premarket approval application for a medical device. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced.

NTP Information Cited
The FDA used the NTP bioassay on 4,4-Methylenedianiline Dihydrochloride in their evaluation of potential risk of polyurethane elastomer materials which may be present in the devices and may degrade over time and release degradation products which are potential carcinogens in animals. (TR-248)

  • Type: Proposed Rule
  • February 15, 1995
  • 60 FR 08595
13552-44-8
1995 EPA
Food and Feed Additive Regulations for d-Limonene, Dihydro-5-Pentyl-2(3H)-Furanone, and Dihydro-5-Heptyl-2(3H)-Furanone

EPA proposes to establish food/feed additive regulations for residues of the insecticide d-limonene when used as an active ingredient in insect-repellent tablecloths and in insect repellent strips used in food/feed-handling establishments.

NTP Information Cited
Data on the oral toxicity of d-limonene was summarized in the NTP 2-year bioassay and comprehensive literature review. TR-347

  • Type: Final Rule
  • February 08, 1995
  • 60 FR 7511
5989-27-5
1995 EPA
Acephate, Triadimefon, Iprodione, and Imazalil; Revocation of Food Additive Regulations

EPA is proposing to revoke food additive regulations for five pesticides which EPA has determined "induce cancer" within the meaning of the Delaney clause of section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). After a full evaluation of all the data and supporting information regarding animal carcinogenicity, the EPA has concluded that exposure to triadimefon results in the induction of hepatocellular adenomas in NMRI mice. Hepatocellular adenomas are considered to be evidence of cancer because hepatocellular adenomas can progress to hepatocellular carcinomas.

NTP Information Cited
EPA supports its conclusion that hepatocellular adenomas can progress to hepatocellular carcinomas with NTP's rationale for combining tumor types for an overall analysis of carcinogenicity (in addition to analyzing them separately).

  • Type: Proposed Rule
  • January 18, 1995
  • 60 FR 3607
1994 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium

Methylene chloride is used as a solvent in the initial step in the manufacturing process of acesulfame potassium and may be present as an impurity in the additive. The FDA used risk assessment procedures to estimate the upper-bound limit of risk presented by methylene chloride.

NTP Information Cited
The FDA used data from the NTP bioassay on methylene chloride to calculate the potency, or unit risk, from exposure to this chemical. TR-306

  • Type: Final Rule
  • December 01, 1994
  • 59 FR 61538
75-09-2
1994 EPA
Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know

EPA is taking this action pursuant to its authority to add to the list those chemicals and chemical categories that meet the EPCRA section 313(d)(2) criteria for addition to the list of toxic chemicals.

NTP Information Cited
Long-chain chlorinated paraffins have not been classified as "probable human carcinogens" by NTP or IARC and the NTP bioassay (TR-305) showed insufficient evidence. Therefore the EPA concludes that there is insufficient evidence to list long-chain chlorinated paraffins on the EPCRA section 313 list.

  • Type: Final Rule
  • November 30, 1994
  • 59 FR 61432
108171-27-3
1994 OSHA
Respiratory Protection

OSHA is proposing to modify its existing standards on respiratory protection so that employers will provide effective protection for employees who wear respirators. agents include saccharin and di-2-ethylhexyl phthalate (DEHP).

NTP Information Cited
One of the respiratory protection testing agents was di-2-ethylhexyl phthalate (DEHP). OSHA cites positive carcinogenic findings of DEHP in two rodent species by NTP as sufficient evidence to preclude its use in respirator quantitative fit testing. TR-217

  • Type: Proposed Rule
  • November 15, 1994
  • 59 FR 58884
117-81-7
1994 EPA
Asbestos Worker Protection; Asbestos-Containing Materials in Schools; Proposed Amendment

The proposed rule would generally extend the coverage provided under the 1986 OSHA Asbestos Standard for Construction to State and local government employees who are not covered by OSHA- or EPA-approved State plans. It also proposes to extend coverage provided under the OSHA Asbestos Standard for General Industry for automotive brake and clutch repair.

NTP Information Cited
The EPA classifies asbestos as a Group A carcinogen as cited in the NTP's 7th Annual Report on Carcinogens. (TR-280) (TR-279) (TR-277) (TR-295)

  • Type: Proposed Rule
  • November 01, 1994
  • 59 FR 54746
12001-28-4
12172-73-5
14567-73-8
12001-29-5
1994 EPA
Drinking Water; National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts

Includes establishment of maximum residual disinfectant level goals (MRDLGs) for chlorine, chloramines, and chlorine dioxide and maximum contaminant level goals (MCLGs) for bromodichloromethane, dibromochloromethane, and bromoform.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis studies of bromodichloromethane (TR-321), chlorinated and chloraminated water (TR-392), bromoform (TR-350), and dibromochloromethane (TR-282) were used as part of the evaluation to set maximum residual disinfectant level goals for these substances.

  • Type: Proposed Rule
  • July 29, 1994
  • 59 FR 38668
75-25-2
75-27-4
124-48-1
CHLORWATERMX
1994 FDA
Secondary Direct Food Additives Permitted in Food for Human Consumption: Cellulose Triacetate

Amendment of food additive regulations to provide for the safe use of cellulose triacetate as an immobilizing agent for lactase for use in reducing the lactose content of milk.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dichloromethane (TR-306) was used to calculate the risk from exposure to dichloromethane as an impurity in cellulose triacetate.

  • Type: Final Rule
  • July 20, 1994
  • 59 FR 36935
75-09-2
1994 EPA
Thirty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator: Receipt of Report and Request for Comments

Receipt of report of the TSCA Interagency Testing Committee to the Administrator. The ITC revised the Priority Testing List including the removal of eight chemicals from the List.

NTP Information Cited
The negative results of the NTP toxicology and carcinogenesis study of the structurally-related N-phenyl-2-napththylamine (TR-333) was used by the ITC in developing its rationale for removing N-phenyl-1-napththylamine from the List.

  • Type: Notice
  • July 13, 1994
  • 59 FR 35720
135-88-6
1994 EPA
Pesticides; Proposed Rule Revoking Certain Food Regulations

Revocation of certain food additive regulations for several pesticides which EPA has determined "induce cancer" within the meaning of the Delaney Clause of section 409 of the Federal Food, Drug and Cosmetic Act.

NTP Information Cited
NTP toxicology and carcinogenesis study of ethylene oxide (TR-326) is cited as one of the studies used for conclusions that ethylene oxide induces cancer in animals.

  • Type: Proposed Rule
  • July 01, 1994
  • 59 FR 33941
75-21-8
1994 EPA
Fuels and Fuel Additives Registration Regulations

Establishment of new requirements for the registration of designated fuels and fuel additives as authorized by sections of the Clean Air Act.

NTP Information Cited
NTP 13-week inhalation study of N-Hexane in B6C3F1 mice is cited as a reference for the neuropathology assessment. (TOX-02)

  • Type: Final Rule
  • June 27, 1994
  • 59 FR 33042
110-54-3
1994 EPA
Dicofol; Revocation of Food Additive Tolerance

Revocation of the food additive tolerance for residues of the pesticide dicofol in or on dried tea.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dicofol (TR-90) showed a statistically significant increase of hepatocellular adenomas and combined hepatocellular adenomas and carcinomas in male mice (B6C3F1) at two doses tested.

  • Type: Final Rule
  • March 09, 1994
  • 59 FR 10993
115-32-2
1994 EPA
d_Limonene; Tolerance Exemption

Exemption from the requirement of a tolerance be established for residues of d-limonene when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.

NTP Information Cited
The NTP toxicology and carcinogenesis study of d-Limonene showed no carcinogenic activity in female rats and mice and in male mice. Clear evidence of kidney-associated carcinogenic activity was noted in male rats. However, the NTP concluded that the male rat kidney carcinogenicity is not predictive of mammalian carcinogenicity. (TR-347)

  • Type: Proposed Rule
  • February 23, 1994
  • 59 FR 8581
5989-27-5
1994 FDA
Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products

Notification of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter oral antiseptic drug products are generally recognized as safe and effective and not misbranded.

NTP Information Cited
The FDA noted that benzethonium chloride is currently being evaluated for carcinogenic potential by the NTP. The agency also nominated gentian violet for study by the NTP after reviewing the available data and deciding that a definitive conclusion regarding its carcinogenic activity could not be reached. (TR-438)

  • Type: Proposed Rule
  • February 09, 1994
  • 59 FR 6084
121-54-0
1994 OSHA
Hazard Communication

Requirement of employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs.

NTP Information Cited
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated.

  • Type: Final Rule
  • February 09, 1994
  • 59 FR 6126
N/A
1994 FDA
Food Additives Permitted for Direct Addition to Food for Human Consumption; Dimethyl Dicarbonate

Amendment to the food additive regulations to provide for the safe use of dimethyl dicarbonate as a yeast inhibitor in dealcoholized and low alcohol wines, Jan 26, 1993, and in ready-to-drink tea beverages.

NTP Information Cited
NTP toxicology and carcinogenesis study on methyl carbamate (TR-328) was used to estimate the human cancer risk from the potential exposure to methyl carbamate stemming from the proposed use of dimethyl dicarbonate as a yeast inhibitor in wine.

  • Type: Final Rule
  • February 04, 1994
  • 59 FR 5317
598-55-0
1994 EPA
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the Counter Human Use; Amendment of Final Monograph of OTC Antihistamine Drug Products

Establishment of conditions under which over-the-counter antihistamine drug products are generally recognized as safe and effective and not misbranded. Dec. 9, 1992. Amendment of final rule to include doxylamine succinate.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study on pyrilamine (TRs 408, 409) was used to determine that pyrilamine maleate is safe for OTC use. The results of an NCTR-toxicology and carcinogenesis study of doxylamine succinate conducted under the auspices of the NTP were used in developing a talk paper concerning the NCTR-findings in animals to inform consumers of these data and the uncertainty of their relevance to humans.

  • Type: Final Rule
  • January 28, 1994
  • 59 FR 4216
469-21-6
91-84-9
1994 FDA
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers

Amendment of food additive regulations to provide for the safe use of 3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6-(1H,3H,5H)-trione as an antioxidant for polyester elastomers in contact with dry food and rubber articles intended for repeated use in contact with food.

NTP Information Cited
Because ethyl acrylate may be present in the additive, data from the NTP toxicology and carcinogenesis study on ethyl acrylate (TR-259) were used to estimate the upper-bound limit of lifetime human risk.

  • Type: Final Rule
  • January 19, 1994
  • 59 FR 2733
140-88-5
1994 EPA
Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know

Addition of 313 chemicals and chemical categories to the list of toxic chemicals required to be reported on under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

NTP Information Cited
EPA considered chemicals designated as possible, probable, or known carcinogens in the Monographs of IARC and the 6th Annual Report on Carcinogens published by the NTP. Also, used results of the NTP toxicology and carcinogenesis studies of C.I. Acid Red 114 (TR-405), C.I. Direct Blue 218 (TR-430), Chlorendic acid (TR-304), 3-Chloro-2-methyl-1-propene (TR-300), Diglycidyl resorcinol ether, (TR-257), 3,3-Dimethoxybenzidine dihydrochloride (TR-372), 3,3-Dimethylbenzidine dihydrochloride (TR-390), and 5,5-Diphenylhydantoin (phenytoin) (TR-404).

  • Type: Final Rule
  • January 12, 1994
  • 59 FR 1788
115-28-6
57-41-0
28407-37-6
6459-94-5
101-90-6 563-47-3
20325-40-0
612-82-8
1993 EPA
Drinking Water Maximum Contaminant Level Goal; Fluoride

Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride.

NTP Information Cited
NTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice.

  • Type: Notice
  • December 29, 1993
  • 58 FR 68826
7681-49-4
1993 EPA
Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Significant New Use Rule

Final Rule: Addition of 21 chemicals and 2 chemical categories to the list of toxic chemicals under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

NTP Information Cited
NTP toxicity study of formic acid (TOX-19) demonstrated sufficient evidence to establish that formic acid can reasonably be anticipated to cause in humans chronic health effects as described in EPCRA section 313(d)(2)(B).

  • Type: Final Rule
  • December 01, 1993
  • 58 FR 63500
64-18-6
1993 EPA
Pesticide Tolerances for Dicamba

Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

NTP Information Cited
Negative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton.

  • Type: Final Rule
  • November 24, 1993
  • 58 FR 62039
33857-26-0
1993 EPA
Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate, and 2,6-Dimethylphenol; Proposed Test Rule, Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Testing Consent Agreements

Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects.

NTP Information Cited
The proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen.

  • Type: Final Rule
  • November 22, 1993
  • 58 FR 61654
121-69-7
1993 EPA
Significant New Uses of Certain Acrylate Esters

Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances).

NTP Information Cited
The EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion.

  • Type: Proposed Rule
  • November 22, 1993
  • 58 FR 61649
140-88-5
1993 EPA
Dichlorvos: Revocation of Food Additive Tolerance

Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used.

  • Type: Final Rule
  • November 10, 1993
  • 58 FR 59663
62-73-7
1993 EPA
Pesticide Tolerance for Dimethoate

Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

NTP Information Cited
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations.

  • Type: Proposed Rule
  • September 01, 1993
  • 58 FR 46147
60-51-5
1993 EPA
Revocation of Food Additive Regulations for Benomyl, Mancozeb, Phosmet, and Trifluralin

Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition.

NTP Information Cited
Ethylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals.

  • Type: Final Rule
  • July 14, 1993
  • 58 FR 37862
96-45-7
1993 EPA
C.I. Pigment Violet #23 (Carbazole Violet), C.I. Pigment Blue #15, C.I. Pigment Green #7, and FD & C Red No. 40; Tolerance Exemptions

Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only.

NTP Information Cited
NTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice.

  • Type: Proposed Rule
  • June 30, 1993
  • 58 FR 34973
147-14-8
1328-53-6
1993 FDA
Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds

Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study on penta­chloro­phenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation.

  • Type: Tentative Final Rule
  • May 12, 1993
  • 58 FR 27959
87-86-5
1993 EPA
Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds

Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite.

NTP Information Cited
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances.

  • Type: Final Rule
  • May 05, 1993
  • 58 FR 26687
7681-49-4
1993 EPA
National Ambient Air Quality Standards For Ozone.

Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time.

NTP Information Cited
Substantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information.

  • Type: Final Decision
  • March 09, 1993
  • 58 FR 13008
10028-15-6
1992 CPSC
Dioxin-containing Wastes

Issued guidelines specifying criteria for determining when any customary or reasonably foreseeable use of an art material can result in chronic hazard.

NTP Information Cited
NTP criteria for assessing the quality and adequacy of animal studies.

  • Type: Final Rule
  • October 09, 1992
  • 57 FR 46624
1992 OSHA
Occupational Exposure to Cadmium

OSHA publishes a new standard for occupational exposure to cadmium.

NTP Information Cited
Clear evidence of carcinogenicity of cadmium in animals was based on NTP's definition of clear evidence of carcinogenicity from the Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation.

  • Type: Final Rule
  • September 14, 1992
  • 57 FR 42102
1992 EPA
Chemicals: Toxic Chemical Release Reporting; Community Right-To-Know; Proposed Significant New Use Rule

The EPA is partially granting a petition submitted by the Governor of New York to add 80 chemicals and 2 chemical categories to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-To-Know Act by proposing to add 68 chemicals and 2 chemical categories.

NTP Information Cited
The EPA used several NTP bioassays as sources of information. (TOX-18) (TR-403) (TR-314) (TR-237) (TR-039) (TR-00A)

  • Type: Final Rule
  • September 08, 1992
  • 57 FR 41020
1338-23-4
108-46-3
80-62-6
630-20-6
303-34-4 148-82-3
1992 FDA
Indirect Food Additives: Paper and Paperboard Components

The FDA is amending the food additive regulations to provide for the safe use of ethyl acrylate in the manufacture of paper and paperboard intended for use in contact with food.

NTP Information Cited
The FDA used data from TR-259 on ethyl acrylate to estimate the upper-bound limit of lifetime human risk from exposure.

  • Type: Final Rule
  • August 07, 1992
  • 57 FR 34865
140-88-5
1992 EPA
Drinking Water: National Primary Drinking Water Regulations-Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation

EPA is promulgating maximum contaminant level goals and National Primary Drinking Water Regulations for 18 synthetic organic and 5 inorganic chemicals.

NTP Information Cited
The MCLG for Di(2-ethylhexyl)adipate was derived from the NTP 2-year dietary study, TR-212. The classification of DEHP as a Group B2 (probable human) carcinogen was based on the NTP 2-year study, (TR-217)

  • Type: Final Rule
  • July 17, 1992
  • 57 FR 31776
117-81-7
103-23-1
1992 EPA
Thirtieth Report of the Interagency Testing Committee: Request for Comments Regarding Priority Testing List of Chemicals

The Priority Testing List was revised by adding one chemical group, the siloxanes, and four chloralkyl phosphates.

NTP Information Cited
At the request of the NTP, TSCA Section 8(d) reports on health effects of bis-(4-chlorophenyl) sulfone were provided to facilitate NTP's evaluation of this chemical.

  • Type: Notice
  • July 09, 1992
  • 57 FR 30608
80-07-9
1992 OSHA
Air Contaminants

Health Effects of Substances to be Regulated

NTP Information Cited
OSHA used data from several NTP studies. (TR-363) (TR-228) (TR-263) (TR-382) (TR-273) (TR-311) (TR-362) (TR-217) (TR-267) (TR-314) (TR-349) (TR-251) (TR-376)

  • Type: Proposed Rule
  • June 12, 1992
  • 57 FR 26042
74-96-4
75-35-4
78-87-5
98-01-1
79-01-6 127-18-4
106-87-6
96-18-4
117-81-7
75-05-8
75-56-9
80-62-6
87-86-5
26471-62-5
106-92-3
1992 OSHA
Occupational Exposure to Methylene Chloride

Notice of informal public hearings concerning OSHA's proposal to modify the existing provisions for controlling employee exposure to methylene chloride.

NTP Information Cited
OSHA based its preliminary estimate of human cancer risk on the NTP mouse study. (TR-306)

  • Type: Proposed Rule
  • June 09, 1992
  • 57 FR 24438
75-09-2
1992 EPA
Ethylene Bisdithiocarbamates: Notice of Intent to Cancel; Conclusion of Special Review

The EPA concludes the Special Review and risk/benefit analysis of EBDCs and announces the intent to cancel registrations and to deny applications for registration for all pesticide products containing EBDCs as an active ingredient unless the registrations/applications comply with the terms and conditions of registration set forth in this Notice. The Agency has determined that use will result in unreasonable adverse effects to humans or the environment.

NTP Information Cited
Data from the NTP bioassay on ethylene thiourea (ETU) were used by the EPA (TR-388)

  • Type: Notice
  • March 02, 1992
  • 57 FR 7484
96-45-7
1992 FDA
Indirect Food Additives: Polymers

The FDA is amending the food additive regulations to provide for the safe use of polyestercarbonate resin.

NTP Information Cited
Residual amounts of methylene chloride have been found in the additive. The FDA estimated the worst-case exposure to methylene chloride from the use of polyestercarbonate resin food-contact articles to be less than 15 micrograms per person per day. The FDA used data from TR-306 to estimate the upper-bound limit of lifetime human risk exposure to methylene chloride.

  • Type: Final Rule
  • February 03, 1992
  • 57 FR 3938
75-09-2
1992 EPA
Aryl Phosphate Base Stocks; Proposed Test Rule Including Reporting and Record-keeping Requirements

EPA proposes that manufacturers, importers and processors of chemical substances in the category of aryl phosphate base stocks be required, under section 4 of the Toxic Substances Control Act to conduct testing.

NTP Information Cited
Reproductive toxicity was demonstrated in the continuous breeding protocol in Swiss mice (1988). The EPA will examine the results of the NTP 2-year bioassay on TCP before deciding whether further oncogenicity testing on any other aryl phosphate is needed. (TR-433)

  • Type: Proposed Rule
  • January 17, 1992
  • 57 FR 2138
1330-78-5
1991 FDA
Topical Acne Drug Products for Over-The Counter Human Use; Amendment of Tentative Final Monograph

Proposed Rule: Amendment to final monograph for over-the counter topical acne products. This amendment reclassifies the topical acne active ingredient benzoyl peroxide to a "more-data-needed" category.

NTP Information Cited
Reference to NTP Init-Prom Comparative Mouse Study using different combinations of initiators and promoters including benzoyl peroxide. (TR-441)

  • Type: Proposed Rule
  • August 07, 1991
  • 56 FR 37622
INIT/PROM
1990 EPA
Identification and Listing of Hazardous Waste; Wood Preserving

The EPA is amending its regulations under the Resource Conservation and Recovery Act by listing as hazardous three categories of wastes from wood preserving operations.

NTP Information Cited
Data from the NTP bioassay on commercial grade pentachlorophenol was used for designating pentachlorophenol as a Class B sub 2 carcinogen. TR-349

  • Type: Final Rule
  • December 06, 1990
  • 55 FR 50450
87-86-5
1990 EPA
Pesticide Tolerances for Oxytetracycline

This document proposes that tolerances be established for residues of the pesticide oxytetracycline in or on the raw agricultural commodities cherries and tomatoes.

NTP Information Cited
Data from the NTP oncogenicity study in rats fed oxytetracycline was used in support of the proposed tolerances. (TR-315)

  • Type: Proposed Rule
  • August 01, 1990
  • 55 FR 31194
2058-46-0
1990 EPA
National Primary and Secondary Drinking Water Regulations; Synthetic Organic Chemicals and InorganicChemicals

EPA is proposing maximum contaminant level goals and National Primary Drinking Water Regulations for organic and inorganic chemicals.

NTP Information Cited
The EPA used data from the following NTP studies: di(ethylhexyl)adipate, dichloromethane, hexachlorocyclopentadiene, di(2-ethylhexl)phthalate, butylbenzyl phthalate,and tetrachlorodibenzo-p-dioxin. (TR-306) (TR-201) (TR-209) (TR-217) (TR-213) (TR-212)

  • Type: Final Rule
  • July 25, 1990
  • 55 FR 30370
75-09-2
77-47-4
1746-01-6
117-81-7
85-68-7 103-23-1
1990 FDA
General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Gel-filled Breast Prosthesis.

FDA is proposing to require the filing of a premarket approval application for the silicone gel-filled breast prosthesis.

NTP Information Cited
Any PMA must include acute, subchronic, and chronic toxicity in vitro and in vivo studies. These studies should include a separate assessment of the carcinogenic risk for each substance contained in the implant. Studies should be performed in accordance with the guide-lines issued by the NTP for all aspects of conducting the assay.

  • Type: Proposed Rule
  • May 17, 1990
  • 55 FR 20568
N/A
1990 FDA
Urethane in Alcoholic Beverages; Research and Survey Reports

The FDA announced the availability of research and survey reports on urethane in alcoholic beverages.

NTP Information Cited
The FDA asked NTP to initiate research to provide the toxicology data necessary to estimate the risk from urethane in alcoholic beverages.

  • Type: Notice
  • March 23, 1990
  • 55 FR 10816
51-79-6
1990 EPA
Chrome Antimony Titanium Buff Rutile; Toxic Chemical Release Reporting; Community Right-to-Know

EPA is denying a petition to exempt Chrome Antimony Titanium Buff Rutile from reporting under the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA)

NTP Information Cited
Based on the 4th Annual Report on Carcinogens, the NTP considers all chromium compounds to be potential carcinogens. (ROC)

  • Type: Other
  • January 08, 1990
  • 55 FR 650
N/A
1990 EPA
National Primary and Secondary Drinking Water Regulations; Fluoride

EPA is soliciting information that has a bearing on the current standards for fluoride in drinking water.

NTP Information Cited
EPA notes that the NTP is in the process of completing a two-year bioassay on fluoride which may provide additional insights. (TR-393)

  • Type: Other
  • January 03, 1990
  • 55 FR 160
7681-49-4
1989 EPA
Ethylene Bisdthiocarbamate (EBDC) Pesticides

EPA Notice of Preliminary Determination to propose cancellation of certain registrations of EBDC products and propose modifications of registrations not cancelled.

NTP Information Cited
NTP carcinogenicity studies of ethylene thiourea (ETU) (CAS: 96-45-7), a common contaminant, metabolite, and degradation product of EBDCs. (TR-388)

  • Type: Notice
  • December 20, 1989
  • 54 FR 52158
96-45-7
1989 EPA
Inert Ingredients in Pesticides

EPA notice for revision of lists of inert ingredients of toxicological concern.

NTP Information Cited
Based on an NTP bioassay di-(2-ethylhexyl)adipate was moved to List 1 ("Inerts of Toxicological Concern") from List 3 ("Inerts of Unknown Toxicity") (TR-212)

  • Type: Notice
  • November 22, 1989
  • 54 FR 48314
103-23-1
1989 FDA
4,4'-Diphenylmethanediamine

FDA final rule amending food additive regulations to allow use of polyamide-imide resins in articles which come into contact with food.

NTP Information Cited
Data from NTP carcinogenesis bioassay used to estimate upper-bound level of lifetime risk from proposed use of 4,4'-diiphenylmethanediamine.

  • Type: Final Rule
  • October 23, 1989
  • 54 FR 43168
1989 EPA
Methyl Ethyl Ketoxime (96-29-7)

EPA final rule under TSCA 4 to require testing for oncogenicity, mutagenicity, developmental toxicity, reproductive toxicity, neurotoxicity, and pharmacokinetics.

NTP Information Cited
Reference to NTP research on MEKA and other NTP studies relevant to the testing requirements.

  • Type: Final Rule
  • September 13, 1989
  • 54 FR 37799
96-29-7
1989 MSHA
Lead

MSHA proposed rule to revise standards for air quality and chemical substances in mines.

NTP Information Cited
NTP recommendation that lead oxide and lead sulfide be ranked a high priority for acute toxicity studies cited in support of proposed lead exposure standard.

  • Type: Proposed Rule
  • August 29, 1989
  • 54 FR 35760
1317-36-8
1314-87-0
1989 EPA
Reportable Quantities: 1,4-dioxane, 2-ethoxyethanol, ethylene oxide, 2-nitropropane, perchloroethylene, and saccharin.

EPA final rule adjusting the reportable quantities (RQ) of these six substances; hazardous substance releases in quantities equal to or greater than their RQ's must be reported to the National Response Center.

NTP Information Cited
"The NTP annual reports (on carcinogens) and IARC monographs are used only as an initial screen for substances to be evaluated for potential carcinogenicity by the Agency. EPA follows the procedures set out in its Guidelines for Carcinogen Risk Assessment to make this determination."

  • Type: Final Rule
  • August 14, 1989
  • 54 FR 33418
75-21-8
110-80-5
79-46-9
123-91-1
81-07-2
1989 EPA
Asbestos

EPA final rule under TSCA 6 to prohibit future manufacture, importation, processing, and distribution in commerce of asbestos in almost all products.

NTP Information Cited
Reference to NTP toxicology and carcinogenesis studies of chrysotile asbestos. (TR-246) (TR-295)

  • Type: Final Rule
  • July 12, 1989
  • 54 FR 29460
12001-29-5
1989 EPA
Reportable quantities: Methyl Isocyanate (624-83-9), Aluminum Thiosulfate, and 258 other substances

EPA final rule retaining statutory RQ for MIC, delisting ammonium thiosulfate, and adjusting the RQ's of 258 hazardous substances.

NTP Information Cited
Use of NTP report on carcinogens used as an initial screen for substances to be evaluated for potential carcinogenicity. MIC studies documented in EHP volume 72 utilized in decision to retain MIC.

  • Type: Final Rule
  • July 12, 1989
  • 54 FR 33426
624-83-9
1989 FDA
Methylene Chloride (75-09-2)

FDA final rule banning use of methylene chloride as an ingredient of cosmetic products.

NTP Information Cited
NTP concluded with respect to their inhalation study on methylene chloride that there was clear evidence of carcinogenicity in mice and female rats and some evidence of carcinogenicity in male rats.

  • Type: Final Rule
  • June 29, 1989
  • 54 FR 27328
75-09-2
1989 EPA
Drinking Water

EPA proposed rule on maximum contaminant level goals and National Primary Drinking Water Regulations for 30 synthetic organic chemicals and 8 inorganic chemicals.

NTP Information Cited
NTP bioassays of chrysotile asbestos, 1,2-dichloropropane, monochlorobenzene, pentachlorophenol,styrene, tetrachloroethylene, and xylenes are cited. (TR-327) (TR-263) (TR-185) (TR-311) (TR-349) (TR-261) (TR-295)

  • Type: Proposed Rule
  • June 23, 1989
  • 54 FR 22062
78-87-5
100-42-5
87-86-5
108-90-7
12001-29-5 127-18-4
1330-20-7
1989 EPA
Copper Phthalocyanine Pigments

EPA proposed rule to exempt Pigments Blue 15, Green 7, and Green 36 from SARA 313 release reporting requirements.

NTP Information Cited
NTP oral studies of PB-15 and PG-7 showed no signs of compound-related toxicity.

  • Type: Proposed Rule
  • May 15, 1989
  • 54 FR 20866
147-14-8
1328-53-6
1989 OSHA
4,4'-Methylenedianiline (13552-44-8)

OSHA proposed rule to establish an 8-hour time-weighted average (TWA) of 10ppb, a short-term exposure limit (STEL) of 100PPB, and associated provisions.

NTP Information Cited
The OSHA-established MDA Advisory Committee used the NTP study "as the principal basis for its carcinogenicity findings." (TR-248)

  • Type: Proposed Rule
  • May 12, 1989
  • 54 FR 20672
13552-44-8
1989 OSHA
Methylene Chloride (75-09-2)

OSHA agenda notice to planned NPRM setting new standard for occupational exposure.

NTP Information Cited
This regulatory action is in response to a petition based on information from NTP and EPA.

  • Type: Notice
  • April 24, 1989
  • 54 FR 16873
75-09-2
1989 EPA
Dinitrobenzenes, Allyl Alcohol, Diethylamine, 2,3-Dichloropropene, Isosafrole, Creosote, Dinitrotoluene, Toluenediisocyanate

EPA proposed rule to add these chemicals to list of chemicals for which release reporting is required under SARA Section 313.

NTP Information Cited
NTP Annual Report on Carcinogens is one of the 4 data sources used by EPA in making carcinogenic evaluations of Section 313 determinations.

  • Type: Proposed Rule
  • April 21, 1989
  • 54 FR 16138
121-14-2
26471-62-5
109-89-7
8021-39-4
1989 EPA
Glycol Ethers

EPA final rule on enforceable testing consent order.

NTP Information Cited
References to NTP studies of ethylene glycol monomethyl ether, 2-ethoxyethanol, and ethylene glycol monobutyl ether.

  • Type: Final Rule
  • April 04, 1989
  • 54 FR 13470
109-86-4
110-80-5
111-76-2
1989 EPA
Captan

EPA notice of intent to cancel registrations.

NTP Information Cited
Rationale for combining organ sites and tumor sites in categorizing captan as a probable human carcinogen was based on NTP list of acceptable organ combinations. (TR-015)

  • Type: Notice
  • February 24, 1989
  • 54 FR 8116
133-06-2
1989 OSHA
Air Contaminants

OSHA final rule amending the air contaminants standard, including new table of Permissible Exposure Limits (PEL).

NTP Information Cited
NTP research cited includes bioassay of perchloroethylene and propylene oxide. (TR-311) (TR-267)

  • Type: Final Rule
  • January 19, 1989
  • 54 FR 2332
127-18-4
75-56-9
1988 EPA
Hazardous Waste Management System

EPA proposed rule to amend RCRA regulations to list as hazardous 4 additional wastes from wood preserving and surface protection processes.

NTP Information Cited
Reference to NTP study demonstrating carcinogenicity of penta­chloro­phenol. (TR-349)

  • Type: Proposed Rule
  • December 30, 1988
  • 53 FR 53282
87-86-5
1988 FDA
Dimethyl Dicarbonate

FDA final rule amending food additive regulations to allow use as yeast inhibitor in wines.

NTP Information Cited
NTP carcinogenesis bioassay of methyl carbamate which is produced in food by dimethyl dicarbonate. (TR-328)

  • Type: Final Rule
  • October 21, 1988
  • 53 FR 41325
598-55-0
1988 EPA
Methyl Ethyl Ketoxime

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
Reference to NTP study of methyl ethyl ketone.

  • Type: Proposed Rule
  • September 15, 1988
  • 53 FR 35838
78-93-3
1988 EPA
2-Mercaptobenzothiazole

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP chronic and subchronic studies of MBT. (TR-332)

  • Type: Final Rule
  • September 07, 1988
  • 54 FR 34514
149-30-4
1988 EPA
Certain Chemicals in Anilines Category

EPA notice of termination of rulemaking because there is no basis for finding of unreasonable risk of injury to health or the environment.

NTP Information Cited
Reference to study of 4-chloro-2-nitroaniline supported by NIEHS.

  • Type: Notice
  • August 19, 1988
  • 53 FR 31814
89-63-4
1988 EPA
Aniline & 7 Substituted Anilines

EPA final rule regarding enforceable testing consent orders under TSCA.

NTP Information Cited
References to studies of p-chloroaniline and 4-nitroaniline supported by NIEHS.

  • Type: Final Rule
  • August 19, 1988
  • 53 FR 31804
106-47-8
100-01-6
20265-96-7
1988 FDA
D& C Red No. 36

FDA final rule permanently listing D Red No. 36 for general use except in eye area.

NTP Information Cited
At FDA's request, NTP compared data on D Red No. 33 with D Red No. 9, a splenic carcinogen. (Nos. 33 and 36 were being considered jointly). (TR-225)

  • Type: Final Rule
  • August 02, 1988
  • 53 FR 29024
5160-02-1
1988 EPA
Benzene

EPA proposed rule on setting NESHAP applicable to benzene equipment leaks, ethylbenzene/styrene and maleic anhydride process vents, benzene storage vessels, and coke byproduct recovery plants.

NTP Information Cited
NTP 2-year chronic study of mice and rats orally exposed found significant incidence of cancers at multiple sites in both sexes and both species. (TR-289)

  • Type: Proposed Rule
  • July 28, 1988
  • 53 FR 28496
71-43-2
1988 FDA
D& C Red No. 8 and D& C Red No. 9

FDA notice of denial of petition for listing for use in ingested lip products and in externally applied drugs and cosmetics.

NTP Information Cited
NCI/NTP chronic rat study concluded that D Red No. 9 is carcinogenic for male F-344 rats. (TR-225)

  • Type: Notice
  • July 15, 1988
  • 53 FR 26886
5160-02-1
1988 EPA
Melamine

EPA proposed rule to delete melamine from list of toxic chemicals for which toxic chemical release reporting is required under SARA Section 313.

NTP Information Cited
NTP bioassay resulted in statistically significant increase in carcinomas in male rats. (TR-245)

  • Type: Proposed Rule
  • June 20, 1988
  • 53 FR 23128
108-78-1
1988 EPA
RCRA Hazardous Waste Identification

EPA notice regarding strategy for setting compound-specific dilution/attenuation factors in the Toxicity Characteristic used by waste generators to determine whether their solid wastes are hazardous.

NTP Information Cited
NTP studies of 1,4-dichlorobenzene, Pyridine, and Methylene Chloride (TR-306) (TR-319) (TR-283)

  • Type: Notice
  • May 19, 1988
  • 53 FR 18024
75-09-2
106-46-7
110-86-1
1988 EPA
Naphthalene

EPA notice of assessment results under Clean Air Act, concluding that the health data base is insufficient to warrant regulation under the CAA.

NTP Information Cited
NTP 2-year inhalation study is currently in progress. (TR-410)

  • Type: Notice
  • March 21, 1988
  • 53 FR 9138
91-20-3
1988 EPA
Isopropanol

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
"The only adequate study" of mutagenicity is a salmonella reverse mutation assay conducted by NTP.

  • Type: Proposed Rule
  • March 16, 1988
  • 53 FR 8638
67-63-0
1988 EPA
Diethylene Glycol Butyl Ether and Diethylene Glycol Butyl Ether Acetate

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP currently is conducting an oncogenicity study of structurally similar glycol ethers.

  • Type: Final Rule
  • February 26, 1988
  • 53 FR 5932
112-34-5
1988 EPA
Dichlorvos

EPA notice of initiation of special review of determine whether registration should be cancelled or otherwise amended in light of carcinogenic and other health effects.

NTP Information Cited
"Based on the NTP oncogenicity studies and chronic toxicity studies, in conjunction with exposure assessments of dietary, worker, residential, and pet risks, EPA has determined that all uses of dichlorvos have met the criterion for initiation of Special Review." (TR-342)

  • Type: Notice
  • February 24, 1988
  • 53 FR 5542
62-73-7
1988 EPA
Commercial Hexane

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
Description of NTP dosing regimen in discussion of subchronic test standards.

  • Type: Final Rule
  • February 05, 1988
  • 53 FR 3382
110-54-3
1987 FDA
Cancer-Causing Residues in Edible Products of Food-Producing Animals

FDA final rule on procedures and criteria to ensure absence of such residues in animals to which drugs, food additives, or color additives have been administered.

NTP Information Cited
References to NTP report on chemical carcinogenesis testing and evaluation.

  • Type: Final Rule
  • December 31, 1987
  • 52 FR 49572
1987 EPA
Polyamine-epichlorohydrin

FDA final rule amending food additive regulations concerning paper and paperboard components.

NTP Information Cited
Reference to NCI/NTP bioassay of 1,2-dichloroethane. (TR-055)

  • Type: Final Rule
  • December 10, 1987
  • 52 FR 46744
107-06-2
1987 EPA

CPSC statement of enforcement policy for household products containing methylene chloride.

NTP Information Cited
NTP inhalation bioassay showed clear evidence of carcinogenicity in female rats and male and female mice. (TR-306)

  • Type: Notice
  • September 14, 1987
  • 52 FR 34698
75-09-2
1987 OSHA
Benzene

OSHA final rule revising existing occupational standard to reduce PEL (Permissible Exposure Limit) from 10 ppm to 8-hr TWA (time weighted average) of 1 ppm and short-term exposure limit of 5 ppm.

NTP Information Cited
NTP 2-year inhalation bioassay; TR-289

  • Type: Final Rule
  • September 11, 1987
  • 52 FR 34460
71-43-2
1987 EPA
2-Ethylhexanol

EPA final rule to require a 2-year oncogenicity bioassay under TSCA Section 4.

NTP Information Cited
Reference to studies of 2-Ethylhexanol supported by NIEHS.

  • Type: Final Rule
  • August 03, 1987
  • 52 FR 28698
104-76-7
1987 EPA
Butyl Benzyl Phthalate

EPA proposed rule to delete this chemical from SARA Section 313 list of chemicals for which release reporting is required.

NTP Information Cited
NTP bioassay results constitute equivocal evidence of carcinogenicity. (TR-213)

  • Type: Proposed Rule
  • July 20, 1987
  • 52 FR 27226
85-68-7
1987 EPA
Ethylene Bisdithiocarbamate (EBDC)

EPA notice of initiation of special review to determine whether regulatory action is required.

NTP Information Cited
NTP is currently conducting an oncogenicity study of ETU, a common contaminant, degradation product, and metabolite of EBDC. (TR-388)

  • Type: Notice
  • July 17, 1987
  • 52 FR 27172
96-45-7
1987 EPA
1,2,4,5-Tetrachlorobenzene

EPA final rule modifying the test substance purity requirements under TSCA Section 4.

NTP Information Cited
NTP-identified test material having 99+% purity not available to manufacturers.

  • Type: Final Rule
  • July 15, 1987
  • 52 FR 26477
95-94-3
1987 EPA
8 Volatile Synthetic Organic Chemicals (VOC's)

EPA final rule for National Primary Drinking Water Regulations setting maximum contaminant levels and monitoring requirements for 8 VOC's under the Safe Drinking Water Act (SDWA).

NTP Information Cited
NTP chronic bioassay of rats and mice showed clear evidence of carcinogenicity of para-dichlorobenzene, TR-319.

  • Type: Final Rule
  • July 08, 1987
  • 52 FR 25690
106-46-7
1987 EPA
Drinking Water

EPA notice of 7 substituted contaminants on SDWA list of 83 contaminants.

NTP Information Cited
Dibromomethane (proposed for removal from list) is being considered for NTP testing. Ethylbenzene (proposed for addition to list) is being tested by NTP.

  • Type: Notice
  • July 08, 1987
  • 52 FR 25720
100-41-4
106-93-4
1987 EPA
Fluoroalkenes

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP subchronic inhalation study of vinylidene fluoride.

  • Type: Final Rule
  • June 08, 1987
  • 52 FR 21516
75-38-7
1987 EPA
Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans (HDD and HDF)

EPA final rule under TSCA to require testing for certain chemicals for HDD/HDF contamination.

NTP Information Cited
Decabromodiphenyl Oxide, in grade used in NTP research, is exempt from this rule because NTP studies showed equivocal evidence of carcinogenicity in male mice and no evidence in female mice. (TR-309)

  • Type: Final Rule
  • June 05, 1987
  • 52 FR 21412
1163-19-5
1987 EPA
11-Aminoundecanoic Acid

EPA final rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP bioassay showed limited evidence of carcinogenicity in animals. (TR-216)

  • Type: Final Rule
  • May 28, 1987
  • 52 FR 19860
2432-99-7
1987 FDA
Indirect Food Additives

FDA final rule allowing use of an additive to paper products which come into contact with food, although the additive may contain minute amounts of methylene chloride as a byproduct of its production.

NTP Information Cited
NTP-supported study of methylene chloride showed carcinogenicity in male and female mice. TR-306.

  • Type: Final Rule
  • May 27, 1987
  • 52 FR 19722
75-09-2
1987 EPA
Cyclohexane

EPA proposed rule on test standards and requirements under TSCA Section 4.

NTP Information Cited
Reference to study of cyclohexane supported by NIEHS.

  • Type: Proposed Rule
  • May 20, 1987
  • 52 FR 19096
110-82-7
1987 EPA
2,4,5-Trichlorophenol

EPA notice of intent to cancel registration as active ingredient for all uses.

NTP Information Cited
References to several NTP studies of 2,3,7,8-TCDD, a contaminant of 2,4,5-TCP. (TR-209)

  • Type: Notice
  • April 29, 1987
  • 52 FR 15549
1746-01-6
1987 EPA
P-Dichlorobenzene

EPA proposed rule to regulate p-dichlorobenzene as a probable human carcinogen under the Safe Drinking Water Act by amending the Maximum Contaminant Level Goal (MCLG).

NTP Information Cited
Based upon the results of the above studies and specifically the conclusions of the NTP report (bioassay of p-dichlorobenzene), EPA is proposing to amend the MCLG. TR-319.

  • Type: Proposed Rule
  • April 17, 1987
  • 52 FR 12876
106-46-7
1987 EPA
8 Polybrominated Biphenyls (PBB's) and Tris

EPA final rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244.

  • Type: Final Rule
  • January 26, 1987
  • 52 FR 2699
67774-32-7
1987 EPA
Penta­chloro­phenol

EPA notice of decision to cancel registrations for all products containing penta­chloro­phenol for all non-wood uses except pulp/paper mill, oil well operations, and cooling tower uses.

NTP Information Cited
EPA requested that NTP reexamine female rat liver lesions from NCI study.

  • Type: Notice
  • January 21, 1987
  • 52 FR 2282
87-86-5
1986 EPA
2-Ethylhexanol

EPA proposed rule on testing under TSCA Section 4.

NTP Information Cited
Reference to study of 2-Ethyl-1-hexanol supported by NIEHS.

  • Type: Proposed Rule
  • December 19, 1986
  • 51 FR 45487
104-76-7
1986 FDA
D& C Red No. 8 and No. 9

FDA final rule permanently listing D Red No. 8 and No. 9 as color additives for use in lip products & externally applied drugs and cosmetics.

NTP Information Cited
This regulation, based on a deminimus interpretation of the Delaney Clause was revoked following a federal court ruling.

  • Type: Final Rule
  • December 05, 1986
  • 51 FR 43877
5160-02-1
1986 OSHA
Methylene Chloride

OSHA ANPR to revise occupational health exposure standards.

NTP Information Cited
"The NTP bioassays have provided clear evidence of carcinogenicity in female rats and in both sexes of mice." TR-306.

  • Type: Other
  • November 24, 1986
  • 51 FR 42257
75-09-2
1986 FDA
FD& C Yellow No. 6

FDA final rule permanently listing FD Yellow No. 6 for use in food, drugs, and cosmetics.

NTP Information Cited
"With the exception of the 1981 NCI/NTP bioassays that were done, the agency considered past studies as inadequate.." (TR-208)

  • Type: Final Rule
  • November 19, 1986
  • 51 FR 41765
2783-94-0
1986 EPA
2-Ethylhexanoic Acid

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
Reference to NTP nomination of compounds containing the 2-ethylhexyl moiety for mutagenicity testing.

  • Type: Final Rule
  • November 06, 1986
  • 51 FR 40318
149-57-5
1986 EPA
1,3-Dichloropropene

EPA notice of special review of pesticides containing 1,3-dichloropropene.

NTP Information Cited
NTP gavage study showed clear evidence of carcinogenicity. TR-269.

  • Type: Notice
  • October 08, 1986
  • 51 FR 36160
542-75-6
1986 OSHA
1,3-Butadiene

OSHA ANPR to reduce occupational exposure.

NTP Information Cited
"OSHA has determined that the magnitude of the carcinogenicity evidence in the NTP animal study, almost 100% of the exposed animals developed tumors, warrants regulatory action." (TR-288)

  • Type: Other
  • October 01, 1986
  • 51 FR 35003
106-99-0
1986 EPA
Nickel Subsulfide and Nickel Carbonyl

EPA notice of determination that no Federal regulation is warranted at this time under CAA.

NTP Information Cited
NTP and NIEHS are currently conducting animal bioassays of selected nickel compounds. (TR-454) (TR-451) (TR-453)

  • Type: Notice
  • September 25, 1986
  • 51 FR 34135
10101-97-0
1313-99-1
12035-72-2
1986 EPA
Guidelines for Assessing Health Risks of Environmental Pollutants

EPA issuance of guidelines for carcinogen risk assessment, mutagenicity risk assessment, health risk assessment of chemical mixtures, and health assessment of suspect developmental toxicants.

NTP Information Cited
Each of these 4 EPA guidelines makes reference to NTP studies.

  • Type: Other
  • September 24, 1986
  • 51 FR 33992
1986 EPA
Bisphenol A

EPA final rule to require a 90-day inhalation subchronic toxicity study with particular emphasis on pulmonary effects, under TSCA Section 4.

NTP Information Cited
NTP oral gavage bioassay provides needed data to evaluate subchronic toxicity of PBA. TR-215.

  • Type: Final Rule
  • September 18, 1986
  • 51 FR 33047
80-05-7
1986 EPA
Dioxin-containing wastes

EPA denial of petition to amend rule listing certain dioxin-containing wastes as acute hazardous wastes.

NTP Information Cited
NTP bioassay study of HXCDD referred to in docket. TR-198.

  • Type: Other
  • September 15, 1986
  • 51 FR 32670
57653-85-7
1986 EPA
1,2-Dichloropropane

EPA final rule to require testing under TSCS Section 4.

NTP Information Cited
NTP 2-year bioassay "is adequate to determine the oncogenic potential of DCP." Also notes NTP concern over DCP in drinking water as indicating need for oral exposure in testing. TR-263.

  • Type: Final Rule
  • September 09, 1986
  • 51 FR 32079
78-87-5
1986 EPA
Pentachloroethane

EPA final rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP bioassay demonstrated limited evidence of carcinogenicity in lab animals. TR-232.

  • Type: Final Rule
  • September 09, 1986
  • 51 FR 32077
76-01-7
1986 EPA
1,1-Dichloroethylene

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
NTP's 2-year gavage study was the "only study considered by EPA to have an adequate protocol to demonstrate a chemical's lack of oncogenic potential," although this study may not have achieved a sufficiently high dose." TR-228

  • Type: Proposed Rule
  • August 12, 1986
  • 51 FR 28840
75-35-4
1986 FDA
Listing of D& C Orange No. 17 for Use in Externally Applied Drugs and Cosmetics

FDA final rule permanently listing D Orange No. 17 as a color additive for use in externally applied drugs and cosmetics.

NTP Information Cited
NTP publication cited reporting 50% of 86 compounds tested by NTP between 7/81-7/84 were determined to induce some carcinogenic effect.

  • Type: Final Rule
  • August 07, 1986
  • 51 FR 28331
1986 EPA
11-Aminoundecanoic Acid

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP carcinogenesis bioassay shows 11-AA induces malignant tumor response in male rats and also can cause non-oncogenic effects in lab animals. TR-216.

  • Type: Proposed Rule
  • July 22, 1986
  • 51 FR 26273
2432-99-7
1986 EPA
Toluenediamines

EPA notice of termination of investigation of occupational exposure in light of evidence of carcinogenicity.

NTP Information Cited
Bioassays conducted under the NTP have demonstrated that 2,4-Toluenediamine causes cancer in lab animals. (TR-162)

  • Type: Notice
  • July 10, 1986
  • 51 FR 25070
95-80-7
1986 EPA
Chlorinated Benzenes

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP studies of 1,2,4,5-TCB, 1,2-DCB, & 1,4-DCB. (TR-319) (TR-255)

  • Type: Final Rule
  • July 08, 1986
  • 51 FR 24657
106-46-7
95-50-1
95-94-3
1986 EPA
8 Polybrominated Biphenyls (PBB's) and Tris

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
Reference to NTP bioassay of polybrominated biphenyl mixture. TR-244.

  • Type: Proposed Rule
  • July 07, 1986
  • 51 FR 24555
67774-32-7
1986 OSHA
Asbestos, Tremolite, Anthrophyllite, and Actinolite

OSHA final rule amending standard for occupational exposure and establishing a PEL.

NTP Information Cited
NTP studies involved oral administration of chrysotile, amosite, tremolite and crocidolite asbestos to lab animals.

  • Type: Final Rule
  • June 20, 1986
  • 51 FR 22612
12001-28-4
14567-73-8
12172-73-5
1986 EPA
Methylcyclopentane and Commercial Hexane

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
NTP is conducting a subchronic inhalation toxicity test and is supporting reproductive and developmental toxicity testing. (TOX-02)

  • Type: Final Rule
  • May 15, 1986
  • 51 FR 17854
110-54-3
96-37-7
1986 EPA
Cresols

EPA final rule to require testing under TSCA Section 4.

NTP Information Cited
NTP is planning range-finding and subchronic studies. (TOX-09)

  • Type: Final Rule
  • April 28, 1986
  • 51 FR 15771
1319-77-3
1986 OSHA
1,3-Butadiene

OSHA notice responding to EPA referral under TSCA Section 9 and announcing preliminary conclusion that current PEL should be revised.

NTP Information Cited
"The magnitude of the carcinogenicity evidence in the NTP animal studies warrants regulatory action." (TR-288)

  • Type: Notice
  • April 11, 1986
  • 51 FR 12526
106-99-0
1986 EPA
Pentachloroethane

EPA proposed rule promulgating a significant new use rule under TSCA Section 5. (Final rule published 9/9/86.)

NTP Information Cited
NTP bioassay demonstrated evidence of carcinogenicity in both sexes of rats and mice. TR-232.

  • Type: Proposed Rule
  • March 24, 1986
  • 51 FR 10024
76-01-7
1986 EPA
Perchloroethylene

EPA correction of previous FR notice to assess perchloroethylene as a potentially toxic air pollutant under the Clean Air Act Section 112.

NTP Information Cited
NTP toxicology and carcinogenesis studies in rats and mice. TR-311.

  • Type: Notice
  • March 05, 1986
  • 51 FR 7718
127-18-4
1986 EPA
Formamide

EPA notice of decision not to require further testing under TSCA Section 4, pursuant to federal district court ruling that EPA, in lieu of a negotiated testing agreement, require testing or give reasons for not requiring testing.

NTP Information Cited
NTP testing of formamide over 5 doses in 4 strains of salmonella; no indication of mutagenic activity seen.

  • Type: Notice
  • February 27, 1986
  • 51 FR 6929
75-12-7
1986 OSHA
4,4'-Methylenedianiline (MDA)

OSHA notice responding to EPA referral of MDA under TSCA Section 9 and announcing determination that the risk described by EPA may be eliminated or reduced by a workplace standard.

NTP Information Cited
"The most persuasive study has been conducted by the National Toxicology Program" in leading OSHA "to the conclusion that this chemical is carcinogenic in animals and may be carcinogenic to humans." (TR-248)

  • Type: Notice
  • February 26, 1986
  • 51 FR 06748
13552-44-8
1986 USDA
Irradiation of Pork

USDA final rule to permit gamma radiation to control Trichinella Spiralis.

NTP Information Cited
NTP review of histopathology data on mice fed irradiated chicken, requested by FDA, concluded that data did not demonstrate a carcinogenic response.

  • Type: Final Rule
  • January 15, 1986
  • 51 FR 1769
1985 EPA
Hydroquinone

EPA proposed rule on testing standards for hydroquinone.

NTP Information Cited
NTP 2-year gavage study will provide data for comparison with dermal contact data from required toxicokinetic studies. (TR-366)

  • Type: Proposed Rule
  • December 30, 1985
  • 50 FR 53160
123-31-9
1985 EPA
Perchloroethylene

EPA notice of assessment of perc as a potentially toxic air pollutant and intent to list under CAA Section 112.

NTP Information Cited
NTP inhalation study, which showed a carcinogenic potential in male rats and both sexes of mice, "has resulted in this notice of intent to list." (TR-311)

  • Type: Notice
  • December 26, 1985
  • 50 FR 52880
127-18-4
1985 EPA
Tri­chloro­ethyl­ene

EPA notice of assessment of TCE as a potentially toxic air pollutant and intent to list under CAA Section 112. (This rule was clarified on 3/5/86.)

NTP Information Cited
"The conclusion that TCE is a probable carcinogen is based on the findings of the NCI (1976) and NTP (1982) mouse studies..." (TR-243)

  • Type: Notice
  • December 23, 1985
  • 50 FR 52422
79-01-6
1985 EPA
Hydroquinone

EPA final rule requiring testing under TSCA Section 4.

NTP Information Cited
Carcinogenicity testing not required because NTP conducting 2-year bioassay. (TR-366)

  • Type: Final Rule
  • December 20, 1985
  • 50 FR 53145
123-31-9
1985 FDA
Methylene Chloride

FDA proposed rule to ban use in cosmetic products.

NTP Information Cited
NTP studies concluded that methylene chloride is a carcinogen in mice and can induce cancer at sites remote from the site of administration. (TR-306)

  • Type: Proposed Rule
  • December 18, 1985
  • 50 FR 51551
75-09-2
1985 OSHA
Benzene

OSHA proposed rule on occupational exposure to benzene to reduce PEL from 10 ppm to 8-hr TWA to 1 ppm to reduce risk of leukemia and other adverse health consequences.

NTP Information Cited
"NTP has demonstrated statistically significant, dose-dependent increase in tumors of multiple sites for both sexes of two species." (TR-289)

  • Type: Final Rule
  • December 10, 1985
  • 50 FR 50512
71-43-2
1985 EPA
Hazardous Waste Management System

EPA proposed rule to list used oil as hazardous waste.

NTP Information Cited
Reference to two NTP perchloroethylene inhalation studies of mice and rats which EPA is evaluating and expects to result in a B-2 classification of perc. (TR-311)

  • Type: Proposed Rule
  • November 29, 1985
  • 50 FR 49258
127-18-4
1985 EPA
Propylene Oxide

EPA final rule to require testing for developmental toxicity under TSCA Section 4.

NTP Information Cited
NTP 2-year studies on rats and mice demonstrated evidence of carcinogenicity. (TR-267)

  • Type: Final Rule
  • November 27, 1985
  • 50 FR 48762
75-56-9
1985 EPA
Synthetic Organic Chemicals, Inorganic Chemicals, and Microorganisms

EPA proposed rule to establish Recommended Maximum Contaminant Levels as part of the National Primary Drinking Water Regulation under the Safe Drinking Water Act.

NTP Information Cited
NTP studies of 1,2-dichloropropane; monochlorobenzene; dichlorobenzene; 1,2 dibromoethane; penta­chloro­phenol; toluene; xylene; 2,3,7,8-TCDD; and ingestion of asbestos. (TR-327) (TR-371) (TR-319) (TR-263) (TR-349) (TR-255) (TR-210) (TR-261)

  • Type: Proposed Rule
  • November 13, 1985
  • 50 FR 46936
1330-20-7
108-88-3
106-46-7
78-87-5
1746-01-6 87-86-5
95-50-1
106-93-4
108-90-7
12001-28-4
12001-29-5
12172-73-5
14567-73-8
1985 EPA
Volatile Synthetic Organic Chemicals

EPA notice of new evidence and requests for comment on new NTP report on tetrachloroethylene.

NTP Information Cited
EPA reopened comment period specifically to provide opportunity for comment on NTP report.

  • Type: Notice
  • November 13, 1985
  • 50 FR 47025
127-18-4
1985 EPA
Pentabromoethylbenzene

EPA proposed rule on testing under TSCA Section 4.

NTP Information Cited
NTP tests were performed using Salmonella typhimurium.

  • Type: Proposed Rule
  • November 13, 1985
  • 50 FR 46785
85-22-3
1985 EPA
Volatile Synthetic Organic Chemicals

EPA final rule promulgating National Primary Drinking Water regulations.

NTP Information Cited
NTP rat and mice inhalation bioassay of tetrachloroethylene demonstrated carcinogenicity in both species. NTP gavage bioassay of p-dichlorobenzene showed carcinogenicity in both sexes of mice and female rats showed no evidence of carcinogenicity. (TR-319) (TR-311)

  • Type: Final Rule
  • November 13, 1985
  • 50 FR 46880
106-46-7
127-18-4
1985 EPA
2-Mercaptobenzothiazole

EPA proposed rule requiring testing under TSCA Section 4.

NTP Information Cited
NTP carcinogenesis study in progress. (TR-332)

  • Type: Proposed Rule
  • November 06, 1985
  • 50 FR 46121
149-30-4
1985 EPA
Fluoroalkenes

EPA proposed rule requiring testing.

NTP Information Cited
NTP study of vinylidene fluoride.

  • Type: Proposed Rule
  • November 06, 1985
  • 50 FR 46133
75-38-7
1985 FDA
Cinnamyl Anthranilate

FDA final rule prohibiting use in human food.

NTP Information Cited
NTP panel on Chemical Carcinogenesis Testing and Evaluation recommended continued use of the B55526 C55523 and F55521 mouse.

  • Type: Final Rule
  • October 23, 1985
  • 50 FR 42929
87-29-6
1985 EPA
Methylene Chloride

EPA ANPR announcing initiation of comprehensive regulatory investigation.

NTP Information Cited
NTP inhalation bioassay demonstrated carcinogenicity in two species. (TR-306)

  • Type: Other
  • October 17, 1985
  • 50 FR 42037
75-09-2
1985 EPA
1,3-Butadiene

EPA notice of intent to list under CAA Section 112 as a potentially toxic air pollutant.

NTP Information Cited
Reference to NTP mouse study which was prematurely terminated due to excess deaths.

  • Type: Notice
  • October 10, 1985
  • 50 FR 41466
106-99-0
1985 EPA
1,3-Butadiene

EPA referral to OSHA under TSCA Section 9.

NTP Information Cited
Reference to NTP report on toxicological and carcinogenesis studies. (TR-288)

  • Type: Other
  • October 10, 1985
  • 50 FR 41393
106-99-0
1985 EPA
Dioxin-containing wastes

EPA tentative denial of petition to amend the rule listing certain dioxin-containing wastes as acute hazardous wastes.

NTP Information Cited
Reference to NCI/NTP bioassay of HXCDD. (TR-202)

  • Type: Other
  • October 08, 1985
  • 50 FR 41125
57653-85-7
1985 EPA
Hexachlorocyclopentadiene

EPA notice of intent not to regulate and solicitation of information.

NTP Information Cited
Ongoing NTP study. (TR-437)

  • Type: Notice
  • October 01, 1985
  • 50 FR 40154
77-47-4
1985 EPA
Chloroprene

EPA notice of intent not to regulate and solicitation of information.

NTP Information Cited
Ongoing NTP carcinogenicity and reproductive hazard study.

  • Type: Notice
  • September 27, 1985
  • 50 FR 39632
126-99-8
1985 EPA
Benzyl Butyl Phthalate

EPA proposed test rule.

NTP Information Cited
NTP planned reproduction effects and cancer studies make it unnecessary to require health effects testing at this time. (TR-458)

  • Type: Proposed Rule
  • September 06, 1985
  • 50 FR 36446
85-68-7
1985 FDA
Certain Color Additives

FDA final rule postponing closing dates for provisional listing of certain color additives to allow uninterrupted use while scientific evaluation continues.

NTP Information Cited
NTP found a clear relationship between D Red No. 9, which has indicated carcinogenic effects and D Red No. 33 that provides a basis for concern about the possible carcinogenicity of No. 33. (TR-225)

  • Type: Final Rule
  • September 04, 1985
  • 50 FR 35783
5160-02-1
1985 EPA
Chlorinated Benzenes

EPA notice of intent not to regulate chlorinated benzenes under CAA.

NTP Information Cited
NTP carcinogenesis testing of 1,4-dichlorobenzene is currently underway. (TR-319)

  • Type: Notice
  • August 13, 1985
  • 50 FR 32628
106-46-7
1985 EPA
Manganese

EPA decision not to regulate manganese under CAA.

NTP Information Cited
Regulation not needed at this time because NTP has scheduled carcinogenicity testing and is conducting mutagenicity studies. (TR-428)

  • Type: Other
  • August 13, 1985
  • 50 FR 32627
10034-96-5
1985 FDA
Irradiation of Food

FDA final rule to permit gamma radiation of pork to control Trichinella Spiralis, citing NTP study which concluded that histopathological data did not show a carcinogenic response.

NTP Information Cited
NTP review, conducted at FDA's request, concluded that data did not demonstrate a carcinogenic response.

  • Type: Final Rule
  • July 22, 1985
  • 50 FR 29658
1985 EPA
4,4-Methylenedianiline

EPA notice of decision to refer to OSHA under TSCA Section 9.

NTP Information Cited
NTP study demonstrated that dihydrochloride salt of 4,4-MDA is carcinogenic in both sexes of rats and mice. (TR-248)

  • Type: Proposed Rule
  • July 05, 1985
  • 50 FR 27674
13552-44-8
1985 FDA
Certain Color Additives

FDA proposed rule to postpone closing dates on provisional listing of certain color additives.

NTP Information Cited
NTP examined data on D Red Nos. 9 and 33 and concluded that there is a relationship between them that provides a basis for concern about the possible carcinogenicity of No. 33. (TR-225)

  • Type: Proposed Rule
  • June 26, 1985
  • 50 FR 26377
5160-02-1
1985 FDA
Irradiation of Food

FDA final rule to permit irradiation of dry or dehydrated enzyme preparations.

NTP Information Cited
NTP review, conducted at FDA's request, concluded that data did not demonstrate a carcinogenic response.

  • Type: Final Rule
  • June 10, 1985
  • 50 FR 24190
1985 EPA
Methyl Chloroform

EPA notice of assessment as a potentially toxic air pollutant and determination that regulation under CAA is not warranted.

NTP Information Cited
EPA awaiting results of NTP carcinogenicity bioassay. (TR-262)

  • Type: Notice
  • June 10, 1985
  • 50 FR 24314
71-55-6
1985 EPA
Diethylenetriamine

EPA final rule on testing requirements under TSCA Section 4.

NTP Information Cited
NTP conducted Ames Salmonella/Microsome Plate Test with negative results.

  • Type: Final Rule
  • May 23, 1985
  • 50 FR 21398
111-40-0
1985 EPA
2-Ethylhexanoic Acid

EPA proposed rule on testing under TSCA Section 4.

NTP Information Cited
NTP tests of four chemicals containing 2-ethylhexyl showed them to be animal oncogenes; NTP plans test of 2-ethylhexanol.

  • Type: Final Rule
  • May 17, 1985
  • 50 FR 20679
104-76-7
1985 EPA
Bisphenol A

EPA proposed rule on testing under TSCA Section 4.

NTP Information Cited
"EPA finds that sufficient data are available from the NTP bioassay report to reasonably predict that ingested BPA is not oncogenic...EPA believes appropriate developmental toxicity testing has been conducted at NTP." (TR-215)

  • Type: Proposed Rule
  • May 17, 1985
  • 50 FR 20691
80-05-7
1985 EPA
Cyromazine

EPA notice of determination to issue conditional registration under FIFRA.

NTP Information Cited
NTP bioassay demonstrated that high dose ingestion induced cancer. NTP study of Melamine, a metabolite of Cyromazine. (TR-245)

  • Type: Notice
  • May 15, 1985
  • 50 FR 20373
108-78-1
1985 EPA
Methylene Chloride

EPA notice of initiation of accelerated review under TSCA Section 4.

NTP Information Cited
NTP inhalation studies demonstrated carcinogenicity. (TR-306)

  • Type: Notice
  • May 14, 1985
  • 50 FR 20126
75-09-2
1985 FDA
Irradiation of Food

FDA final rule to permit irradiation of additional herbs, spices, and vegetable seasonings.

NTP Information Cited
FDA has referred USDA study to NTP for peer review.

  • Type: Final Rule
  • April 18, 1985
  • 50 FR 15415
N/A
1985 EPA
Dioxin-containing Wastes

EPA final rule listing certain dioxin-containing wastes as acute hazardous wastes.

NTP Information Cited
Re-evaluation by NTP of NCI study of HXCDD. (TR-202)

  • Type: Final Rule
  • January 14, 1985
  • 50 FR 1978
57653-85-7
1984 EPA
Certain Polyamino Chemical Substances

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP bioassay indicated that the dihydrochloride salt of Methylenedianiline is carcinogenic in both sexes of rats and mice. (TR-248)

  • Type: Proposed Rule
  • December 27, 1984
  • 49 FR 50209
13552-44-8
1984 EPA
[(Dinitrophenyl)Azo]-[2,4-Diamino-5-Methoxybenzene] Derivatives; Proposed Determination of Significant New Uses

EPA proposed rule promulgating a significant new use rule under TSCA Section 5.

NTP Information Cited
NTP and others have shown carcinogenic potential of close structural analogues of phenylenediamines.

  • Type: Proposed Rule
  • October 25, 1984
  • 49 FR 42960
1984 EPA
1,1,1-Trichloroethane

EPA final rule identifying specific chemical substance and mixture testing requirements.

NTP Information Cited
EPA did not propose chronic effects or oncogenicity testing because an NTP study is expected to provide sufficient information. (TR-262)

  • Type: Final Rule
  • October 10, 1984
  • 49 FR 39810
71-55-6
1984 OSHA
Ethylene Oxide

OSHA final standard on occupational PEL.

NTP Information Cited
NTP studies show significance of all malignancies rather than increases in only certain types of cancer, in calculating human risk. (TR-326)

  • Type: Other
  • June 22, 1984
  • 49 FR 25734
75-21-8
1984 EPA
Dichloromethane

EPA proposed rule to withdraw testing requirements under TSCA. Evaluation of data indicates dichloromethane does not present unreasonable risks.

NTP Information Cited
EPA expects NTP inhalation bioassay to be sufficient to characterize oncogenic hazards. (TR-306)

  • Type: Proposed Rule
  • June 19, 1984
  • 49 FR 25009
75-09-2
1984 EPA
Nitrobenzene

EPA proposed rule to withdraw testing requirements under TSCA. Ongoing government and manufacturers' tests are expected to meet all testing.

NTP Information Cited
EPA concluded that NTP oncogenicity and subchronic effects testing would be sufficient and so didn't require further testing for these effects.

  • Type: Proposed Rule
  • June 19, 1984
  • 49 FR 25013
98-95-3
1984 EPA
Volatile Synthetic Organic Chemicals

EPA proposed rule for National Primary Drinking Water Regulations establishing Recommended Maximum Contaminant Levels for several VOC's.

NTP Information Cited
NTP studies of trichlorethylene; 1,1,1-trichlorethane; 1,1-dichloroethylene; and p-dichlorobenzene. (TR-319) (TR-228) (TR-243) (TR-273) (TR-262)

  • Type: Proposed Rule
  • June 12, 1984
  • 49 FR 24330
106-46-7
79-01-6
71-55-6
75-35-4
1984 EPA
Fluoroalkenes

EPA notice of proposed decision to adopt a negotiated testing program in lieu of required testing.

NTP Information Cited
NTP planning testing of tetrafluoroethane and vinylidene. (TR-228)

  • Type: Proposed Rule
  • June 04, 1984
  • 49 FR 23112
75-35-4
1984 EPA
Bis(2-Ethylhexyl) Terephthalate

EPA notice of decision to adopt negotiated testing program.

NTP Information Cited
NTP has nominated two chemicals similar to the metabolites of DOTP for genotoxicity testing.

  • Type: Notice
  • June 04, 1984
  • 49 FR 23110
104-76-7
4376-20-9
1984 EPA
Toluene

EPA notice of decision not to regulate under CAA based on studies showing toluene not to pose a significant risk to public health. This decision is not relevant to regulation of toluene as a VOC under the air quality standards for ozone.

NTP Information Cited
NTP is currently conducting a lifetime bioassay on toluene. (TR-371)

  • Type: Notice
  • May 25, 1984
  • 49 FR 22195
108-88-3
1984 EPA
Formaldehyde

EPA ANPR announcing decision that TSCA Section 4f priority consideration is applicable in 2 exposure categories, and initiating a regulatory investigation.

NTP Information Cited
Federal Panel on Formaldehyde, under the aegis of NTP, reviewed CIIT's bioassay methodology from CIIT inhalation study showing nasal cancer in rats.

  • Type: Other
  • May 23, 1984
  • 49 FR 21870
50-00-0
1984 EPA
Calcium, Cobalt, and Lead Napthenates

EPA notice of determination not to require testing.

NTP Information Cited
NTP planning testing of cobalt naphthenate and cobalt sulfate; NTP currently testing naphthenic acid; NTP has completed mutagenicity tests of lead naphthenate.

  • Type: Notice
  • May 21, 1984
  • 49 FR 21411
10124-43-3
61789-51-3
1984 EPA
1,3-Butadiene

EPA ANPR and invitation to submit data on controlling exposures, following recent bioassays establishing carcinogenicity.

NTP Information Cited
NTP chronic oncology studies show carcinogenicity in both sexes of rats and mice; NTP planning further teratology testing. (TR-288)

  • Type: Other
  • May 15, 1984
  • 49 FR 20524
106-99-0
1984 EPA
Cyromazine

EPA proposed temporary feed additive regulation.

NTP Information Cited
NTP bioassay of Melamine, a metabolite of Cyromazine, showed significant increase in bladder carcinomas in male rats. (TR-245)

  • Type: Proposed Rule
  • April 27, 1984
  • 49 FR 18130
108-78-1
1984 EPA
Cyromazine

EPA proposed rule to establish feed additive regulation setting temporary maximum permissible residue level in poultry feed.

NTP Information Cited
NTP bioassay of Melamine, a metabolite of Cyromazine, showed a significant increase in bladder carcinomas in male rats. (TR-245)

  • Type: Notice
  • April 27, 1984
  • 49 FR 18120
108-78-1
1984 EPA
Cyromazine

EPA notice of proposed conditional registration under FIFRA for temporary period.

NTP Information Cited
As a result of the reported oncogenicity of Melamine in the NTP bioassay, the agency stopped the Cyromazine registration process...until it could review the NTP bioassay. (TR-245)

  • Type: Notice
  • April 27, 1984
  • 49 FR 18172
108-78-1
1984 EPA
Isophorone

EPA notice of decision to adopt negotiated testing program.

NTP Information Cited
NTP's initiation of a long-term bioassay, together with CMA proposed testing, make it unnecessary to require TSCA Section 4 testing. (TR-291)

  • Type: Notice
  • January 17, 1984
  • 49 FR 2012
78-59-1
1984 EPA
1,2-Dichloropropane

EPA proposed test rule

NTP Information Cited
NTP 2-year bioassay (TR-263)

  • Type: Proposed Rule
  • January 06, 1984
  • 49 FR 899
78-87-5
1984 EPA
1,2-Butylene Oxide

EPA notice of determination not to require testing.

NTP Information Cited
NTP inhalation bioassay of 1,2-butylene oxide. (TR-329)

  • Type: Notice
  • January 04, 1984
  • 49 FR 503
106-88-7
1984 EPA
Certain Alkyl Epoxides

EPA ANPR on testing under TSCA

NTP Information Cited
NTP subchronic study on 1,2-Epoxyhexadecane applied dermally.

  • Type: Other
  • January 04, 1984
  • 49 FR 449
7320-37-8
1984 EPA
Hydroquinone

EPA Proposed test rule under TSCA Section 4.

NTP Information Cited
EPA is not proposing oncogenicity testing of Hydroquinone since NTP is currently conducting a 2-year bioassay. (TR-366)

  • Type: Proposed Rule
  • January 04, 1984
  • 49 FR 438
123-31-9
1984 EPA
Ethylene Oxide

EPA notice of determination not to require testing.

NTP Information Cited
NTP chronic inhalation bioassay. (TR-326)

  • Type: Notice
  • January 03, 1984
  • 49 FR 200
75-21-8
1984 EPA
Anilines

EPA ANPR to require health and environmental effects testing.

NTP Information Cited
NTP confirmatory study of effects of dietary exposure to 4-Chloroaniline Hydrochloride. (TR-351)

  • Type: Other
  • January 03, 1984
  • 49 FR 108
20265-96-7
1983 EPA
Hexafluoropropylene Oxide

EPA proposed test rule under TSCA Section 4.

NTP Information Cited
NTP planning to conduct Ames assay.

  • Type: Proposed Rule
  • December 30, 1983
  • 48 FR 57686
428-59-1
1983 EPA
Cyromazine

EPA issuance of emergency exemptions for use of an unregistered pesticide.

NTP Information Cited
Applicant's earlier request for specific exemption was denied because of results of NTP study of Melamine, a metabolite of Cyromazine.

  • Type: Proposed Rule
  • December 14, 1983
  • 48 FR 55624
108-78-1
1983 EPA
Chlorinated Benzenes

EPA proposed rule to withdraw most testing requirements.

NTP Information Cited
NTP mutagenesis testing of Monochlorobenzene; 1,2,4-Trichlorobenzene and Penta­chloro­phenol. NTP toxicity testing of Monochlorobenzene,ortho and para-Dichlorobenzenes. (TR-255) (TR-261)

  • Type: Proposed Rule
  • December 07, 1983
  • 48 FR 54836
120-82-1
108-90-7
608-93-5
95-50-1
1983 OSHA
Hazard Communication

OSHA final rule setting final occupational safety and health standard requiring hazard assessment and communication to employees of chemical hazard information.

NTP Information Cited
For purposes of hazard communication, OSHA defines a carcinogen as any substance found to be a confirmed or suspected carcinogen by NTP, IARC, or OSHA itself.

  • Type: Notice
  • November 25, 1983
  • 48 FR 53280
N/A
1983 EPA
Formaldehyde

EPA notice of reconsideration as to whether TSCA Section 4f priority consideration is appropriate.

NTP Information Cited
Federal Panel on Formaldehyde, formed by several agencies under the aegis of NTP, reviewed study of Formaldehyde.

  • Type: Notice
  • November 18, 1983
  • 48 FR 52507
50-00-0
1983 EPA
Bis­(2-Ethyl­hexyl­)­Tere­phthalate­; Response to the Interagency Testing Committee

EPA notice that it is not initiating TSCA Section 4 test requirement rulemaking because ongoing tests are expected to provide sufficient information to predict toxicity.

NTP Information Cited
Two chemicals similar to metabolites of DOTP have been nominated for genotoxicity testing by the NTP.

  • Type: Notice
  • November 14, 1983
  • 48 FR 51845
104-76-7
4376-20-9
1983 EPA
Tris

EPA notice that it is not initiating TSCA Section 4A test requirement rulemaking because ongoing tests are expected to provide sufficient information to predict toxicity.

NTP Information Cited
NTP testing of compounds containing the 2-ethylhexyl moiety. (TR-274)

  • Type: Notice
  • November 14, 1983
  • 48 FR 51842
78-42-2
1983 OSHA
Asbestos

OSHA emergency temporary standard to reduce occupational PEL.

NTP Information Cited
NTP studies in which Chrysotile, Amosite, Tremolite, and Crocidolite in feed were administered to lab animals with no increased incidence of tumors.

  • Type: Notice
  • November 04, 1983
  • 48 FR 51086
12001-28-4
12001-29-5
12172-73-5
14567-73-8
1332-21-4
1983 OSHA
Ethylene Dibromide

OSHA NPRM to revise current occupational exposure standard to reduce PEL, restrict dermal exposure, etc.

NTP Information Cited
NTP/NCI inhalation bioassay concluded that EDB was carcinogenic to rats. (TR-210)

  • Type: Notice
  • October 07, 1983
  • 48 FR 45956
106-93-4
1983 EPA
4,4-Methylenedianiline

EPA ANPR of EPA/OSHA joint initiation of regulatory action under TSCA and OSHA Act.

NTP Information Cited
NTP bioassay indicated that the dihydrochloride salt of 4,4-MDA is carcinogenic in both sexes of rats and mice. (TR-248)

  • Type: Notice
  • September 20, 1983
  • 48 FR 42898
13552-44-8
1983 EPA
4,4-Methylenedianiline

EPA notice that it is not initiating a TSCA Section 4A health effects test rule because recent NTP study shows MDA to be carcinogenic in rats and mice.

NTP Information Cited
The data from the NTP bioassay are sufficient...and further oncogenicity testing is unnecessary. (TR-248)

  • Type: Notice
  • July 11, 1983
  • 48 FR 31806
13552-44-8
1983 EPA
Formamide

EPA notice of determination not to require additional health effects testing.

NTP Information Cited
NTP genotoxicity testing, together with importer's subchronic effects testing, make it unnecessary to require Section 4A testing.

  • Type: Notice
  • May 23, 1983
  • 48 FR 23098
75-12-7
1983 EPA
Isophorone

EPA notice that it is not initiating TSCA Section 4A test requirements because of adequate ongoing tests.

NTP Information Cited
NTP long-term bioassay, together with manufacturers' tests, make it unnecessary to require Section 4A testing. (TR-291)

  • Type: Notice
  • January 06, 1983
  • 48 FR 727
78-59-1
1982 EPA
Acetonitrile

EPA notice that testing by NTP and manufacturers is adequate and further testing under TSCA Section 4 is not warranted.

NTP Information Cited
NTP chronic and mutagenic effects testing, together with manufacturers' testing, make it unnecessary to require Section 4A testing. (TR-447)

  • Type: Notice
  • December 29, 1982
  • 47 FR 58020
75-05-8
1982 EPA
Pyridine

EPA notice that testing under TSCA Section 4 is not warranted.

NTP Information Cited
Sufficient data have been or are being developed on Pyridine for carcinogenicity and chronic effects by the NTP. (TR-283)

  • Type: Notice
  • December 29, 1982
  • 47 FR 58031
110-86-1
1982 EPA
Hexachlorocyclopentadiene

EPA notice that testing under TSCA Section 4 is not warranted.

NTP Information Cited
NTP is conducting a 2-year inhalation oncogenicity bioassay. (TR-437)

  • Type: Notice
  • December 29, 1982
  • 47 FR 58023
77-47-4
1982 EPA
Xylenes

EPA notice that testing under TSCA Section 4 is not warranted.

NTP Information Cited
NTP cancer bioassay and teratogenicity study of mixed Xylenes.

  • Type: Notice
  • December 16, 1982
  • 47 FR 56392
1330-20-7
1982 EPA
Toluene

EPA notice that a test rule under TSCA Section 4 is unnecessary because information from current and planned testing will be sufficient.

NTP Information Cited
NTP has completed a subchronic oral study and NTP/NCI carcinogenesis testing program is starting chronic studies.

  • Type: Notice
  • December 16, 1982
  • 47 FR 56391
108-88-3
1982 EPA
Asbestos

EPA final rule requiring schools to identify friable asbestos-containing building materials, to maintain records, and to notify employees and PTA's.

NTP Information Cited
Reference to report on Amosite, Chrysotile, Crocidolite and nonfibrous Tremolite for NIEHS oral ingestion studies.

  • Type: Final Rule
  • May 27, 1982
  • 47 FR 23360
12001-28-4
12001-29-5
14567-73-8
1332-21-4
12172-73-5
1982 FDA
Carcinogenic Chemicals in Food and Color Additives

FDA ANPR on setting a policy for regulating use of food and color additives containing carcinogens.

NTP Information Cited
Reference to NIEHS report on species to species comparison of carcinogenicity data.

  • Type: Other
  • April 02, 1982
  • 47 FR 14464
1982 CPSC
Urea Formaldehyde Foam Insulation

CPSC final rule banning UF foam insulation in residences and schools.

NTP Information Cited
Statement by the Director of NIEHS that Formaldehyde is an animal carcinogen is cited in support of the ban.

  • Type: Final Rule
  • April 02, 1982
  • 47 FR 14366
50-00-0
1982 EPA
Chlorinated Paraffins

EPA notice that testing under TSCA Section 4 is not being required because currently planned testing is sufficient.

NTP Information Cited
NTP bioassays of two chlorinated paraffin compounds. (TR-305) (TR-308)

  • Type: Notice
  • January 08, 1982
  • 47 FR 1017
108171-27-3
108171-26-2
1981 EPA
Benzidine, o-Tolidine, o-Dianisidine

EPA notice that testing under TSCA Section 4 is not required due to adequacy of current testing programs of NTP and other federal agencies.

NTP Information Cited
Current and planned testing by NTP cited.

  • Type: Notice
  • November 05, 1981
  • 46 FR 55004
92-87-5
119-93-7
1981 EPA
Alkyl Phthalate and Benzyl Butyle Phthalate

EPA notice of preliminary decision not to require testing under TSCA, following receipt of CMA testing proposal.

NTP Information Cited
NTP conducting mutagenicity, oncogenicity, and reproductive and mitochondrial effects studies of various alkyl phthalate esters.

  • Type: Other
  • October 30, 1981
  • 46 FR 53775
85-68-7
1981 CPSC
Urea Formaldehyde Foam Insulation

CPSC proposed rule to ban manufacture or sale in the US.

NTP Information Cited
NIEHS participation on Task Force to verify findings concerning carcinogenicity of urea formaldehyde.

  • Type: Proposed Rule
  • February 05, 1981
  • 46 FR 11188
50-00-0
1980 EPA
Asbestos

EPA proposed rule to require schools to identify friable asbestos-containing materials and to notify employees and PTAs.

NTP Information Cited
NIEHS-sponsored studies of effects of asbestos exposure.

  • Type: Other
  • September 17, 1980
  • 45 FR 61966
1332-21-4
1980 EPA
Chloromethane and Chlorinated Benzenes

EPA proposed rule to require testing under TSCA Section 4.

NTP Information Cited
NTP has selected 1,4-Dichlorobenzene for teratogenicity testing.

  • Type: Proposed Rule
  • July 18, 1980
  • 45 FR 48524
106-46-7