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Regulatory Actions for Years 2010 to 2017


Agency for Toxic Substances and Disease Registry (ATSDR)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice 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.

December 30, 2014 -- 79 FR 78324
‘‘Review all relevant data, including the most recent, best-available, peer reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods.’’ The CHAP reviewed all of the available data on phthalates, including publications in peer-reviewed scientific journals; reports submitted by manufacturers to the U.S. EPA; 10 and authoritative reviews from agencies such as the Agency for Toxic Substances and Disease Registry (ATSDR), the European Chemical Agency (ECHA), the International Agency for Research on Cancer (IARC), Center for the Evaluation of Research on Human Reproduction (CERHR), National Toxicology Program (NTP); and the National Research Council (NRC). (CHAP, 2014, p. 12). In addition, the CHAP invited scientific experts to present their latest research in areas such as biomonitoring, epidemiology, phthalate syndrome, toxicology of phthalates mixtures, phthalates mode of action, and species differences. The CHAP also invited a coauthor of an NRC report (NRC, 2009) to present the NRC panel’s perspective on risk assessment methodology, especially as applied to phthalates risk assessment. Furthermore, the CHAP heard testimony from federal agency scientists, as well as scientists representing manufacturers of phthalates alternatives.
Notice 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 http://www.atsdr.cdc.gov/toxprofiles/index.asp and http://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.

December 15, 2014 -- 79 FR 74093
Each profile will include an examination, a summary, and an interpretation of available toxicological information and epidemiological evaluations. This information and these data identify the levels of significant human exposure for the substance and for the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available (or in the process of development) in order to identify levels of significant human exposure. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of a program of research to provide such information.  79-01-6
127-18-4
7783-06-4
463-58-1
56-38-2

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California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice 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.

May 11, 2017 -- Proposition 65
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. 100-42-5
Notice 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.

May 05, 2017 -- Proposition 65
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. 32534-81-9
Notice 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).  

April 06, 2017 -- Proposition 65
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. 7439-92-1
Notice Draft Technical Support Document on the Proposed Update of the Public Health Goals for Nitrate and Nitrite in Drinking Water Proposed update of the PHGs for nitrate and nitrite published in 1997. OEHHA is proposing to retain the original PHG values.

December 16, 2016 -- Proposition 65

NTP (2001). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Nitrite (CAS No. 7632-00-0) in F344/N Rats and B6C3F1 Mice. National Toxicology Program, U.S. Department of Health and Human Services, Research Triangle Park, NC.

NTP (2014). Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: US Department of Health and Human Services, Public Health Service.

7632-00-0
Notice Ethylene Glycol n-mono Butyl Ether (EGBE) RELs – Draft for Scientific Review Panel on Toxic Air Contaminants (SRP) The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a revised draft document summarizing the toxicity and derivation of RELs for Ethylene Glycol n-mono Butyl Ether (EGBE). These documents will be reviewed and discussed by the Scientific Review Panel on Toxic Air Contaminants (SRP) at its meeting on December 14, 2016 in Sacramento, CA. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

November 14, 2016 -- Proposition 65
NTP (2000). Toxicology and carcinogenesis studies 2-butoxyethanol (CAS NO. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). 111-76-2
Notice Tertiary-Butyl Acetate (TBAc) Cancer Unit Risk Factor (URF) Document - Scientific Review Panel on Toxic Air Contaminants (SRP) Review Draft The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a revised draft document summarizing the carcinogenicity and derivation of an inhalation cancer unit risk factor (URF) for tertiary-Butyl Acetate (TBAc). Inhalation cancer unit risk factors are used to estimate lifetime cancer risks associated with inhalation exposure to a carcinogen. These documents will be reviewed and discussed by the Scientific Review Panel on Toxic Air Contaminants (SRP) at its meeting on December 14, 2016 in Sacramento, CA.

November 14, 2016 -- Proposition 65
National Toxicology Program (NTP). 1995. Toxicology and Carcinogenesis Studies of t-Butyl Alcohol (CAS No. 75-65-0) In F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR436, NIH Publication No. 95-3167. National Institute of Environmental Health Sciences, Research Triangle Park, NC. 75-65-0
Notice 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.

October 21, 2016 -- Proposition 65
National Toxicology Program (NTP, 2014). Report on Carcinogens, Thirteenth Edition, US Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina. 87-86-5
Notice Comments on DPR’s Draft Risk Management Directive for 1,3-Dichloropropene OEHHA has provided a number of comments on DPR's proposal for regulatory mitigation for 1,3-Dichloropropene (1,3-D).

October 10, 2016 -- Proposition 65
NTP, 1985. Toxicology and carcinogenesis studies of Telone II in F344/N rats and B6C3F1 mice. NTP Technical Report Series #269. 542-75-6
Notice 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.

September 23, 2016 -- Proposition 65
NTP (1989). Toxicology and carcinogenesis studies of hydroquinone in F344/N rats and B6C3F1 mice. National Toxicology Program, Research Triangle Park, NC.

NTP (1992). NTP report on the toxicity studies of antimony potassium tartrate in F344/N rats and B6C3F1 mice (drinking water and intraperitoneal injection studies). NTP Tox 11, NIH Publication No. 92-3130, March 1992. National Toxicology Program, Research Triangle Park, NC.
123-31-9
28300-74-5
Notice 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.

August 05, 2016 -- Proposition 65
National Toxicology Program (NTP, 2011). National Toxicology Program. Toxicology and Carcinogenesis Studies of 1‑Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 564. NIH Publication No. 11-5906. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 106-94-5
Notice 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.

July 29, 2016 -- Proposition 65
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1 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. 71133-14-7
Notice 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.

May 27, 2016 -- Proposition 65
National Toxicology Program (NTP, 2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1 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. 71133-14-7
Notice 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.

April 22, 2016 -- Proposition 65
 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. 100-42-5
Notice 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.

April 22, 2016 -- Proposition 65
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. 100-42-5
Notice 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.

April 08, 2016 -- Proposition 65
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. 107-21-1
Notice 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.

April 01, 2016 -- Proposition 65
NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A; Report No. NTP-CERHR-BPA-07

National Toxicology Program, U.S. Department of Health and Human Services, Center for the Evaluation of Risks to Human Reproduction (2007) (Published Nov 26, 2007).

Birnbaum LS, Bucher JR, Collman GW, Zeldin DC, Johnson AF, Schug TT, Heindel JJ (2012). Consortium-based science: the NIEHS's multipronged, collaborative approach to assessing the health effects of bisphenol, Environmental Health Perspectives, 120(12):1640-4. Heindel JJ, Newbold RR, Bucher JR, Camacho L, Delclos KB, Lewis SM, Vanlandingham M, Churchwell MI, Twaddle NC, McLellen M, Chidambaram M, Bryant M, Woodling K, Gamboa da Costa G, Ferguson SA, Flaws J, Howard PC, Walker NJ, Zoeller RT, Fostel J, Favaro C, Schug TT (2015). NIEHS/FDA CLARITY-BPA research program update. Reproductive Toxicology, 58:33-44.
80-05-7
Notice Ethylene Glycol N-Mono Butyl Ether (EGBE) RELs - Scientific Review Panel On Toxic Air Contaminants (SRP) Review Draft The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a Scientific Review Panel on Toxic Air Contaminants (SRP) review draft document summarizing the toxicity and derivation of RELs for Ethylene Glycol n-mono Butyl Ether (EGBE). These documents will be reviewed and discussed by the SRP at their meeting on March 4, 2016 in Sacramento, CA. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

February 03, 2016 -- Proposition 65
NTP (2000).  Toxicology and Carcinogenesis Studies of 2-Butoxyethanol (CAS 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).  National Toxicology Program, Research Triangle Park, NC.

NTP (2015).  NTP Nonneoplastic Lesion Atlas: Nose, Epithelium - Accumulation, Hyaline Droplet.  Retrieved October 2015.
11-76-2
Notice 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.

October 30, 2015 -- Proposition 65
“The combined incidence of benign and malignant liver tumors (hepatocellular adenoma and carcinoma) was significantly increased in mice of both sexes following dietary exposure to Dowicide EC-74 and in males following exposure to technical-grade pentachlorophenol. In males exposed to either formulation, the separate incidence of malignant liver tumors also was significantly increased” (footnote not in original).

“The incidences of benign and malignant adrenal-gland tumors (pheochromocytoma) combined, benign adrenal-gland tumors, and preneoplastic adrenal-gland lesions (medullary hyperplasia) were significantly increased in mice of both sexes exposed to Dowicide EC-7.”

“The incidence of malignant tumors of the blood vessels (hemangiosarcoma) of the spleen and/or liver was significantly increased in female mice exposed to technical-grade pentachlorophenol or Dowicide EC-7.”

“In male F344 rats (Chhabra et al. 1999, NTP 1999), increased incidences of tumors were observed in the tunica vaginalis of the testes and in the nose. In a stop-exposure study, the incidence of malignant mesothelioma of the tunica vaginalis was significantly increased after dietary exposure to 99% pure pentachlorophenol for one year, followed by one year of observation. Although the increased incidence of squamous-cell carcinoma of the nose was not statistically significant, this is a rare tumor, and its incidence exceeded the range for historical controls.”

NTP (2014). Report on Carcinogens, Thirteenth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina. 

87-86-5
Notice 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

August 28, 2015 -- Proposition 65
NTP, Report on Carcinogens 7440-02-0
Notice Availability of Hazard Identification Materials For Nitrapyrin And Diaminotoluenes. "Diaminotoluene (Mixed)" And Nitrapyrin Are Under Review For Possible Delisting OEHHA is referring nitrapyrin and diaminotoluene (mixed) to the Carcinogen Identification Committee (CIC), the state’s qualified experts for carcinogenicity determinations under Proposition 65, for review.

August 28, 2015 -- Proposition 65
The NTP is mandated to provide to Congress an annual report on carcinogens. The last report was provided in October, 2014 (Exhibit). In this report 2,5-diaminotoluene was not listed as either a known human carcinogen, or a chemical suspected of being a human carcinogen.

Note that no stomach tumors were found in the 2-year NTP study in the same species.] may confirm the lack of genotoxic activity of toluene-2,5-diamine sulfate in vivo.

National Toxicology Program, NTP Technical Report on the Toxicology and Carcinogenesis Studies of Two Pentachlorophenol Technical-Grade Mixtures in B6C3Fl Mice, NTP TR 349, NIH Publication No. 89-2804,
March, 1989.

NTP provided historical control data (updated in 1999) for testicular tumors  (currently termed testicular adenoma) among 20 NCI/NTP dietary carcinogenicity studies in male Fischer 344 rats given the NIH-07 diet (the same diet used for the study of 2,5-diaminotoluene).

Ashby J and Tennant RW (1988). Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP. Mutat Res 204 (1): 17-115.

National Cancer Institute (1978) Bioassay of 2,5-Toluenediamine Sulfate for Possible Carcinogenicity (CAS No. 6369-59-1) NCI-GG-TR-126.

95-80-7
6369-59-1
Notice 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

July 22, 2015 -- Proposition 65
NTP (National Toxicology Program).  1990.  NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfural (CAS No. 98-01-1) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-382, MRID 46011016.

National Toxicology Program (NTP). 1999. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Furfuryl Alcohol (CASRN 98-00-0) in F344/N Rats and B6C3F1 Mice. NTP TR 482. NIH Publication No. National Toxicology Program, Research Triangle Park, NC.

Irwin, R. (1990). NTP Technical report on the toxicology and carcinogenesis studies of furfural in F344/N rats and B6C3F1 mice (gavage studies).  NIH publication number 90-2837, National Toxicology Program.

NJP (National Toxicology Program). 1993. NTP Technical Report on the Toxicology and Carcinogepesis Studies of Furan (CAS No. 110-00-9) in F344/N rats and B6C3F1 mice (Gavage Studies). NTP-TR-402.

98-01-1
98-00-0
110-00-9
Notice 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.

July 17, 2015 -- Proposition 65
National Toxicology Program.  Bioassay of parathion for possible carcinogenticity.  National Cancer Institute Carcinogenesis Technical Report Series 1979; 70: 1-123 56-38-2
Notice 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.

July 10, 2015 -- Proposition 65
National Toxicology Program (NTP, 2011). National Toxicology Program. Toxicology and Carcinogenesis Studies of 1‑Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 564. NIH Publication No. 11-5906. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.  109-94-5
Notice 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.

June 19, 2015 -- Proposition 65
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.  107-21-1
Notice Proposed Reference Exposure Levels for Carbonyl Sulfide – SRP Review Drafts The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document for review by the State's Science Review Panel on Toxic Air Contaminants (SRP). The SRP review draft document summarizes the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide. This document is for review and comment by the Science Review Panel at their meeting on June 19, 2015. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

May 21, 2015 -- Proposition 65
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97,
TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per
test plate with and without induced liver extract from rats or hamsters. They reported a
weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.
CEBS Accession Number: 002-01834-0001-0000-9
463-58-1
Notice 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".

April 23, 2015 -- Proposition 65
NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A (2008) [Attachment to OEHHA, 2009]

 

National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2008). "NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A." NTP, US Department of Health and Human Services, Research Triangle Park, NC, NIH Publication No. 08-5994.

80-05-7
Notice 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.

April 20, 2015 -- Proposition 65
DB [a,h]A: NTP (1981): “Reasonably anticipated to be a human carcinogen” 53-70-3
Notice 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

March 24, 2015 -- Proposition 65
In 2010, the NTP published a report on beta-myrcene (β‑myrcene), entitled Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), that concludes that the chemical causes cancer (NTP, 2010).  This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.

NTP (2010). Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Technical Report Series No. 557, NIH Publication No. 10-5898. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

123-35-3
Notice 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.

February 27, 2015 -- Proposition 65
In 2011, NTP published the Twelfth Edition of the Report on Carcinogens (NTP, 2011). This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations for styrene. NTP concluded that styrene is “reasonably anticipated to be a human carcinogen based on limited evidence of carcinogenicity from studies in humans, sufficient evidence of carcinogenicity from studies in experimental animals, and supporting data on mechanisms of carcinogenesis” (emphasis in original). OEHHA is relying on NTP’s discussion of data and conclusions in the report that styrene causes cancer.

National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391.

100-42-5
Notice 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.

January 12, 2015 -- Proposition 65
REFERENCES FOR SECTION 25602
US Department of Health and Human Services, National Toxicology Program. 13th Report on Carcinogens (October 2014).
N/A
Notice 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.

December 10, 2014 -- Proposition 65
The chemical form of inhaled lead affects its solubility and therefore influences its absorption from the respiratory tract and gut. Some lead forms (e.g., lead acetate, lead chloride) are soluble in water; other forms (e.g., lead sulfide) are much less soluble (NTP 2011).

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

7439-92-1
Comment Notice of Public Comment Period and Workshops on Draft Reference Exposure Levels for Carbonyl Sulfide The Office of Environmental Health Hazard Assessment (OEHHA) is releasing for public review a draft document on the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide (COS).

October 17, 2014 -- Proposition 65
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97, TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per test plate with and without induced liver extract from rats or hamsters. They reported a weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.  CEBS Accession Number: 002-01834-0001-0000-9 from http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=A35125.

463-58-1
Notice 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

July 01, 2014 -- Proposition 65
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.
107-21-1
107-21-1
Notice 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.

June 27, 2014 -- Proposition 65
The National Toxicology Program (NTP, 1986) conducted a chronic (2 year) toxicity
“bioassay” in F344 rats and B6C3F1 mice of benzene by gavage in corn oil. Doses
were 0, 25, 50, and 100 mg/kg-day for females and 0, 50, 100, and 200 mg/kg-day for males. Dose-related lymphocytopenia and leukocytopenia were observed in both
species in all dosed groups. Mice exhibited lymphoid depletion of the thymus and
spleen and hyperplasia of the bone marrow.
71-43-2
Notice 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.

May 02, 2014 -- Proposition 65
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. 99-97-8
Notice 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.

April 11, 2014 -- Proposition 65
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. 107–21–1
Notice 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).

April 19, 2013 -- Proposition 65
NTP-CERHR (2008). NTP-CERHR Monograph on the Potential Human Reproductive And Developmental Effects of Bisphenol A. Research Triangle Park, NC, National Toxicology Program: NIH Publication No. 08 – 5994.

NTP (1985) Bisphenol A: reproduction and fertility assessment in CD-1 mice when administered in the feed. NTP-85-192. Re­search Triangle Park, NC.

80-05-7
Notice 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)

July 24, 2012 -- Proposition 65
NTP (2010). National Toxicology Program. Toxicology and Carcinogenesis Studies of 3,3',4,4'-Tetrachloroazobenzene (TCAB) (CAS No. 14047-09-7) in Harlan Sprague-Dawley Rats and B6C3F1 Mice (Gavage Studies).  Technical Report Series No. 558. NIH Publication No. 11-5899. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 14047-09-7
Notice 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.

May 03, 2011 -- Proposition 65
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. 24382-04-5
Notice 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.

May 03, 2011 -- Proposition 65
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. 63-05-8
Notice 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.

May 03, 2011 -- Proposition 65
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Dibromoacetonitrile (CAS No. 3252-43-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 544. NIH Publication No. 10-5886. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 3252-43-5
Notice 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.

February 25, 2011 -- Proposition 65
NTP-CERHR. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Acrylamide. NIH Publication No. 05-4472. (2005) 79-06-1
Notice 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

January 07, 2011 -- Proposition 65
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CAS No. 822-36-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 535. NIH Publication No. 07-4471. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC. 822-36-6
Notice 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.

September 16, 2010 -- Proposition 65
NTP (1982a). Bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin for possible carcinogenicity (gavage study). TR 201. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

NTP (1982b). Carcinogenesis bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin (CAS no. 1746-01-6) in Osborne-Mendel rat and B6C3F1 mice (gavage study). TR 109. National Toxicology Program, DHHS, Public Health Service, Research Triangle Park, NC.

NTP (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.

NTP (2001). Report on Carcinogens, Ninth Edition. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

NTP (2004). Toxicology and carcinogenesis studies of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in female Harlan Sprague-Dawley rats (gavage study). TR 521. NIH publication No. 04-4455. National Toxicology Program, Public Health Service, National Institutes of Health, Research Triangle Park, NC.

NTP/NIEHS (1989). Symposium on Significance of Foci of Cellular Alteration in the Rat Liver. Toxicol Pathol 17:557-735.
Final Rule 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.

April 02, 2010 -- Proposition 65
National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Cumene (CAS No. 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 542.

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.

5589-96-8
98-82-8

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Centers for Disease Control and Prevention (CDC)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice with Comment Period 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.

April 06, 2017 -- 82 FR 16839
In 2012, the National Toxicology Program (NTP) concluded that there is sufficient evidence that BLLs at less than 10 [micro]g/dL and at less than 5 [micro]g/dL are associated with adverse health effects in both children, less than 18 years, and in adults, 18 years and older. 7439-92-1
Final Rule 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.

September 19, 2013 -- 78 FR 57505
National Toxicology Program Report on Carcinogens (ROC).  Various methods of evaluation were established to determine if cancers or types of cancer are added to the World Trade Center-related health conditions.  One method is to evaluate findings of the 9/11 exposure with the National Toxicology Program’s categorization as a known or reasonably anticipated human carcinogen. NA
Proposed 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.

July 02, 2013 -- 78 FR 39670
National Toxicology Program Report on Carcinogens (ROC):  arsenic and cadmium are known to be a human carcinogen. 7440-38-2
7440-43-9
Final Rule 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.

April 17, 2013 -- 78 FR 22794
National Toxicology Program Report on Carcinogens (ROC):  Polychlorinated biphenyls are reasonably anticipated to be a human carcinogen. 1336-36-3
Final Rule 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.

September 12, 2012 -- 77 FR 567138
Five main sources, including the National Toxicology Program, were used to evaluate whether to add cancers to the WTC-Related Health Conditions list. One of several methods used to identify cancers employed the list of known human carcinogens and those agents reasonably anticipated to be carcinogenic in humans (ROC). NA
Notice 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.

June 13, 2012 -- 77 FR 35574
NTP’s Report on Carcinogens states arsenic and vinyl chloride as known carcinogens (ROC). 7740-38-2
75-01-4

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Consumer Product Safety Commission (CPSC)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed 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.

June 29, 2012 -- 77 FR 38751
According to the ICCVAM Authorization Act, ICCVAM member agencies should promote and encourage the development and use of alternatives to animal test methods for regulatory purposes. Since the establishment of ICCVAM, the CPSC has approved, where applicable, recommendations made by ICCVAM to reduce and refine animal testing applicable to test methods under the FHSA. The CPSC is amending and updating regulations under the FHSA to make the ICCVAM recommendations and the CPSC animal testing policy more accessible and transparent to interested parties. CPSC will also create a page on its website regarding ICCVAM recommendations and new developments in test methods that further reduce or refine animal testing. (ICCVAM) NA

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Department of Defense (DOD)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule 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.

May 05, 2011 -- 76 FR 25569
The National Toxicology Program’s Report on Carcinogens lists hexavalent chromium compounds as known human carcinogens. (ROC) N/A

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Department of Energy (DOE)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice of Proposed Rulemaking and Public Hearings 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.

June 07, 2016 -- 81 FR 12547
National Toxicology Program. Thirteenth Report on Carcinogens. ‘‘Beryllium and Beryllium Compounds.’’ 2014. Accessed on 10/26/2015. 7440-41-7

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Department of Transportation (DOT)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed 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.

December 01, 2011 -- 76 FR 74854
Components of greenhouse gas emissions of light-duty vehicles (benzene, 1,3-butadiene, acetaldehyde, and naphthalene) were cited in the National Toxicology Program’s Report on Carcinogens (ROC). The following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans; acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene. 71-43-2
106-99-0
75-07-0
91-20-3
Final Rule 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.

September 15, 2011 -- 76 FR 57106
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene. 71-43-2
106-99-0
75-07-0
91-20-3
Final Rule 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.

June 27, 2011 -- 76 FR 37283
Saccharin and its salts do not pose a present or potential risk of causing carcinogenic effects on humans. (ROC, Appendix B) 81-07-2

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Department of Veterans Affairs (VA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule 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.

September 09, 2016 -- 81 FR 62419
National Toxicology Program. 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service.

National Toxicology Program. 2015. Report on Carcinogens, Monograph on Trichloroethylene. http://ntp.niehs.nih.gov/ntp/roc/monographs/finaltce_508.pdf
79-01-6

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Drug Enforcement Administration (DEA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule 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.

December 12, 2011 -- 76 FR 77330
DEA used NTP’s Toxicity studies of carisoprodol in rats and mice to support its placement of carisoprodol into Schedule IV of the Controlled Substances Act. 78-44-4

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule 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.

March 17, 2017 -- 82 FR 14171
NTP (National Toxicology Program) (n.d.). Modified One-Generation Studies. (retrieved in 2016).
Final Rule 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.

March 10, 2017 -- 82 FR 14171
There was no evidence of carcinogenicity for male or female mice fed oxytetracycline at 1,875 mg/kg/day for two years. In the rat carcinogenicity study, there was equivocal evidence for carcinogenicity based upon increased incidences of pheochromocytomas of the adrenal gland at the highest doses tested for males of 2,500 and increased incidences of adenomas of the pituitary gland in females at 1,875 mg/kg/day; both doses are extremely high as compared to expected human exposure and above the limit dose. The mutagenicity assays were all negative except for the mouse lymphoma forward mutation assay which was positive only with metabolic activation. Based upon this information and the weight of the evidence as a whole, the EPA has classified oxytetracycline as a ``Group D'' carcinogen (``Not Classifiable as to Human Carcinogenicity''). A review of the same data by the National Toxicology Program's (NTP) Peer Review Committee was in agreement with this classification. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary and was not conducted. 79-57-2
Final Rule 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.

March 10, 2017 -- 82 FR 14617
The National Toxicology Program reported dogs exposed to 5,000 parts per million (ppm) isoamyl acetate via inhalation for one hour showed drowsiness and nasal irritation. Cats exposed to 4,000 ppm isoamyl acetate for 20 minutes experienced eye and nose irritation. 123-92-2
Proposed Rule 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.

February 27, 2017 -- 82 FR 11878
National Toxicology Program (NTP). Systematic literature review on the effects of fluoride onlearning and memory in animal studies. NTP Research Report 1. Research Triangle Park, NC. 2016. 7681-49-4
Proposed Rule 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.

January 19, 2017 -- 82 FR 7562
The National Toxicology Program of the National Institute of Environmental Health Sciences has developed a tool called ‘‘systematic review’’ to assist in WoE evaluations particularly for hazard identification.
Proposed Rule 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.

January 19, 2017 -- 82 FR 7562
The National Toxicology Program of the National Institute of Environmental Health Sciences has developed a tool called "systematic review'' to assist in WoE evaluations particularly for hazard identification. This tool uses a defined set of processes to identify, select, critically assess, and synthesize evidence to arrive at a hazard conclusion for a chemical. It is designed to enhance transparency and informs scientific judgments. The evidence synthesis step involves considering factors that decrease confidence in the body of evidence for a particular health endpoint (e.g. risk of bias, inconsistencies across studies, imprecision) as well as factors that increase confidence (e.g. magnitude of the effect, residual confounding, consistency).
Notice; request for public comment 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.

January 11, 2017 -- 82 FR 3518
National Toxicology Program (NTP). 2005. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Chlorate (CAS No. 7775–09–9) in F344/ N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR 517 NIH Publication No. 06–4457 National Institutes of Health, Public Health Service, U.S. Department of Health and Human Services. December 2005.

 

NTP. 2007. NTP technical report on the 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. NTP, National Institutes of Health, Public Health Service, U.S. Department of Health and Human Services.

 

NTP. 2009. Toxicology and carcinogenesis studies of bromochloroacetic acid (CAS No. 5589–96–8) in F344/N rats and B6C3F1 mice (drinking water studies). Technical Report Series No. 549. Research Triangle Park, NC: U.S. Department of Health and Human Services.

 

NTP. 2014. Toxicology studies of bromodichloroacetic acid (CAS No. 71133–14–7) in F344 rats and B6C3F1 mice and toxicology and carcinogenesis studies of bromodichloroacetic acid in F344/NTac rats and B6C3F1/N mice (drinking water studies). Peer Review Draft, scheduled peer review date; May 22, 2014. Technical Report Series No. 583. Research Triangle Park, NC: U.S. Department of Health and Human Services.

 

NTP. 2016. Systematic Review of the Effects of Fluoride on Learning and Memory in Animal Studies.

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Proposed Rule 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.

January 11, 2017 -- 82 FR 7432
National Toxicology Program. 12th Report on Carcinogens. 2011. 79-01-6 
Notice; request for public comment 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.

January 09, 2017 -- 82 FR 2354
National Toxicology Program (NTP) Report on Carcinogens (RoC), 13th Edition, 2014 (NTP, 2014) in which the NTP classified nPB, identified as 1–BP, as being reasonably anticipated to be a human carcinogen. 106-94-5
Proposed Rule 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.

December 16, 2016 -- 81 FR 91592

National Toxicology Program. 13th Report on Carcinogens. 2014.

79-34-5
Final Rule 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.

December 12, 2016 -- 81 FR 89674

National Toxicology Program. Report on carcinogens. Thirteenth edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. 2014.

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Notice 1-Bromopropane (1–BP); Availability of TSCA Work Plan Chemical Risk Assessment for Public Review and Comment With this notice, EPA is announcing the availability of and opening the public comment period for the draft TSCA Work Plan Chemical risk assessment for 1-Bromopropane (1–BP). EPA develops TSCA Work Plan Chemical assessments using the best available information and approaches. These assessments focus on those TSCA uses of the chemical with significant potential for exposure to humans and/or the environment. EPA issues draft risk assessments for public review and comment, followed by independent peer review in accordance with Agency peer review guidelines. The Agency considers all public and peer review comments as it revises and finalizes the risk assessment. Based on the final TSCA risk assessment, the Agency may either initiate risk reduction actions that are necessary to address the potential risks identified, or may conclude its work on the chemical uses being assessed if no risks are found.

March 08, 2016 -- 81 RF 45
National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP), 2003. "NTP-CERHR Monograph on the potential Human Reproductive and Developmental Effects of 1-Bromopropane."

NTP (National Toxicology Program). (1989). Toxicology and Carcinogenesis Studies of Bromoethane in F344/N Rats and B6C3F1 Mice (Inhalation Studies). (Report No. 363).

NTP (National Toxicology Program). (2011). NTP Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CAS No. 106-94-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). (NTP TR 564; NIH Publication No. 11-5906). Research Triangle Park, NC.

NTP (National Toxicology Program). (2013). Draft Report on Carcinogens. Monograph for 1-Bromopropane. In Office of the Report on Carcinogens. Research Triangle Park, NC.

NTP (National Toxicology Program). (2014). Report on Carcinogens. 13th Edition.
106-94-5
Final Rule 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).

February 12, 2016 -- 81 FR 7466
PCA, a plant metabolite of diflubenzuron, tested positive for splenic tumors in the male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. 106-47-8
Final Rule 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.

February 12, 2016 -- 81 FR 7473
Because of the confounding effects of corn oil on the incidences of pancreatic neoplasm and because of the controversy over the use of the gavage route of administration, the National Toxicology Program (NTP) decided to re-study benzyl acetate using the dosed feed route of administration. In 1993, the NTP conducted a second set of carcinogenicity studies in rats and mice using the dose feed route of administration. 

The point of departure for benzyl acetate is 110 mg/kg/day from the NTP 2-year carcinogenicity study in mice (dietary study) based on decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/day. There was no evidence of carcinogenicity in mice and rats. 

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Final Rule 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.

November 23, 2015 -- 80 FR 72906
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2015. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane.  Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services.  NIH Publication No. 13-5982, September 25, 2013

106–94–5
Denial of Petition 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.

October 08, 2015 -- 80 FR 60818
NTP. 2000. NTP technical report on the toxicology and carcinogenesis studies of 2- butoxyethanol (CAS No. 111–76–2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. https://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr484/index.html.  

 

NTP. 1996. Toxicology and carcinogenesis studies of acetonitrile (CAS No 75–05–8) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. 

 

NTP. 1993. NTP technical report on toxicity studies of ethylene glycol ethers: 2-methoxyethanol, 2-ethoxyethanol, 2-butoxyethanol (CAS Nos. 109–86–4, 110–80–5, 111–76–2) administered in drinking water to F344/N rats and B6C3F1 mice. National Toxicology Program. Research Triangle Park, NC. 26; NIH Publication 93–3349.

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Proposed Rule 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.

April 15, 2015 -- 80 FR 20189
NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Introduction section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Process for Preparation of the Report on Carcinogens section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane. Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services. NIH Publication No. 13–5982, September 25, 2013

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Profile for 1-Bromopropane. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program

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Notice of availability, and request for comments Draft Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability and Request for Comment EPA is announcing the availability of three draft test guidelines for public review and comment that are being added to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screen Program (EDSP): Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. These draft test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducing the test, and are also used by EPA, the public, and companies that submit data to EPA.

January 30, 2015 -- 80 FR 5107
EPA followed the general validation principles of the Organization for Economic Co-Operation and Development (OECD) and the Intergovernmental Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the development of the four non-mammalian Tier 2 tests.
Proposed Rule 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."

January 15, 2015 -- 80 FR 2068
TDI has also been classified by the European Commission (EC) as Category 3 for carcinogenicity (‘‘causes concerns for humans owing to possible carcinogenic effects’’) (Ref. 16) and by the United States National Toxicology Program (NTP) as ‘‘reasonably anticipated to be a human carcinogen’’ (Ref. 17). 9019-85-6
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Supplemental Proposed Rulemaking 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.

December 08, 2014 -- 79 FR 72922
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 http://ntp.niehs.nih.gov/ntp/roc/twelfth/roc12.pdf

Based on consistent views of major scientific bodies (i.e., National Toxicology Program (NTP) in their 12th Report of the Carcinogens (ROC), 7 International Agency for Research on Cancer (IARC) 8 and other international agencies) 9 that consider all Ni compounds to be carcinogenic, we currently consider all Ni compounds to have the potential of being carcinogenic to humans. The 12th Report of the Carcinogens states that the ‘‘combined results of epidemiological studies, mechanistic studies, and carcinogenic studies in rodents support the concept that Ni compounds generate Ni ions in target cells at sites critical for carcinogenesis, thus allowing consideration and evaluation of these compounds as a single group.’’  Although the precise Ni compound (or compounds) responsible for the= carcinogenic effects in humans is not always clear, studies indicate that Ni sulfate and the combinations of Ni sulfides and oxides encountered in the Ni refining industries cause cancer in humans (these studies are summarized in a review by Grimsrud et al., 2010 10). The major scientific bodies mentioned above have also recognized that there are differences in toxicity and/or carcinogenic potential across the different Ni compounds.

Proposed Rule 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

July 25, 2014 -- 79 FR 43350
The derivation of TTC human exposure threshold values for non-cancer endpoints is based on an extensive reference database compiled by Munro, (Ref. 1) which included data on chronic, subchronic, reproductive and developmental toxicity studies primarily derived from the reports of the US National Toxicology Program (NTP), the toxicological monographs of JECFA, the EPA Integrated Risk Information System (IRIS), and the Developmental and Reproductive Toxicology (DART) database compiled by the US National Library of Medicine. These sources were considered to contain well-validated toxicological data for well-defined chemical structures, covering pesticides, food additives, industrial and other types of chemicals. Only studies using the oral route of administration (gavage, diet, drinking water, or capsule) were included. In all, the reference database contained 2941 no-observed-adverse-effect levels (NOAELs) from studies conducted on 613 substances, and from these the most conservative (lowest) NOAEL for each substance was entered on the published database. The NOAELs in the reference database were those selected by the original authors of each study, apart from the studies in the IRIS database, for which the NOAELs were selected by the EPA. Munro commented that some authors were highly conservative in their selection of a NOAEL, but such NOAELs were still used for the database to maintain a conservative approach. Munro also stated that, in the calculation of the TTC values, NOAELs from subchronic studies were divided by a factor of 3 to approximate the NOAELs that are likely to be derived from a chronic study. 75-07-0
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Final Rule 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.

April 28, 2014 -- 79 FR 23414
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: benzene, 1,3-butadiene, formaldehyde; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene. 71-43-2
106-99-0
75-07-0
91-20-3
50-00-0
Final Rule 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).

January 31, 2014 -- 79 FR 5294
para-chloroaniline hydrochloride (PCA), a plant metabolite of diflubenzuron, tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice. TR-351, 1989). 20265-96-7
Final Rule 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.

November 07, 2013 -- 78 FR 66848
National Toxicology Program Report on Carcinogens (ROC):  ortho-nitrotoluene reasonably anticipated to be a human carcinogen. 88-72-2
Proposed 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.

June 10, 2013 -- 78 FR 34820
National Toxicology Program Report on Carcinogens (ROC):  formaldehyde is known to be a human carcinogen. 50-00-0
Proposed 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.

June 10, 2013 -- 78 FR 34796
National Toxicology Program Report on Carcinogens (ROC):  formaldehyde is known to be a human carcinogen. 50-00-0
Proposed 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.

May 29, 2013 -- 78 FR 12782
The National Toxicology Program conducted carcinogenicity studies in mice and rats.  No adverse effects were observed at doses up to 3,570 mg/kg/day. (TR-229). 9000-30-0
Proposed 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.

May 21, 2013 -- 78 FR 8500
National Toxicology Program Report on Carcinogens (ROC): acetaldehyde and naphthalene are reasonably anticipated to be human carcinogens; benzene, 1,3-butadiene and formaldehyde are known human carcinogens. 50-00-0
71-43-2
75-07-0
91-20-3
106-99-0
Proposed 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.

March 13, 2013 -- 78 FR 15913

National Toxicology Program Report on Carcinogens (ROC): o-Nitrotoluene is reasonably anticipated to be a human carcinogen.

88-72-2
Final Rule 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.

October 15, 2012 -- 77 FR 62624
National Toxicology Program Report on Carcinogens (ROC): acetaldehyde and naphthalene are reasonably anticipated to be human carcinogens; benzene, 1,3-butadiene and formaldehyde are known human carcinogens. 75-07-0
91-20-3
71-43-2
106-99-0
50-00-0
Notice 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.

May 23, 2012 -- 77 FR 30856
NTP is testing (tris(chloropropyl)phosphate) (mixture of isomers). 13674-84-5
Other 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.

May 07, 2012 -- 77 FR 26751
(Draft Monograph on Health Effects of Low-Level Lead) 7439-92-1
Proposed 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.

March 28, 2012 -- 77 FR 18752
Benzidine-based dyes are metabolized to its parent molecule, which is a known carcinogen (ROC). Exposure to phthalates in animal studies caused a decreased development of the reproductive system. A study of Di-n-pentyl phthalate showed a decrease in the number of litters from fertile pairs, decreased number of live pups, and decreased fertility and reproduction 92-87-5
131-18-0
Final Rule 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.

February 16, 2012 -- 77 FR 9304
NTP 2-year rodent bioassay of Ni sulfate hexahydrate (water soluble) showed no evidence of carcinogenicity (TR-454); NTP 2-year rodent bioassay of Ni subsulfide showed clear evidence of carcinogenicity (TR-453); NTP’s Report on Carcinogens states considering Ni compounds to be carcinogenic as a group (ROC). 10101-97-0
12035-72-2
Proposed 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.

November 23, 2011 -- 76 FR 72508
NTP Work Cited: EPA cited the National Toxicology Program’s Report on Carcinogens (ROC), which states that nickel compounds are known human carcinogens. NA
Final Rule 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.

October 21, 2011 -- 76 FR 65385
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity. NA
Proposed 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.

October 21, 2011 -- 76 FR 65580
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity. Standardized protocols are referenced. NA
Final Rule 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.

September 15, 2011 -- 76 FR 57106
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene. 71-43-2
106-99-0
75-07-0
91-20-3
Notice 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).

August 12, 2011 -- 76 FR 50226
National Toxicology Program has identified constituents in tobacco products and tobacco smoke as human carcinogens or reasonably anticipated to be human carcinogens. (ROC) N/A
Final Rule 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.

July 27, 2011 -- 76 FR 44811
In carcinogenicity studies in mice and rats, no adverse effects were observed. (TR-229) 9000-30-0
Notice 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.

July 26, 2011 -- 76 FR 44535
BPA is a reproductive and developmental toxicant. Studies show reduced fetal or birth weight or growth early in life, effects on testis of male rats, possible decreased fertility in mice, altered estrous cycling in female rats, and reduced survival of fetuses. There are also reports of endocrine-related low-dose effects on puberty and neurological development. (Monograph on Bisphenol A) 80-05-7
Final Rule 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.

June 22, 2011 -- 76 FR 36349
Ethylene glycol, which is structurally similar to DEGEE, does not cause carcinogenicity in mice. (TR-413) 107-21-1
Final Rule 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.

June 01, 2011 -- 76 FR 31471
Based on the lack of mutagenicity and lack of carcinogenicity in rodents, ethylene glycol is not expected to pose a carcinogenic risk in humans. (TR-26) 109-86-4
110-80-5
111-76-2
Notice Agency Information Collection Activities; Submission to OMB for Review and Approval; 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.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to make changes to and renew an existing approved collection. The ICR Supporting Statement, which is abstracted below, describes the nature of the information collection (including proposed minor form revisions) and its estimated burden and cost.

May 26, 2011 -- 76 FR 30700
Addition of National Toxicology Program Carcinogens rule is estimated to increase 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. N/A
Proposed 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.

May 03, 2011 -- 76 FR 25053
Acetaldehyde is reasonably anticipated to be a human carcinogen. Benzene is characterized as a known human carcinogen. Both are cited in the National Toxicology Program’s Report on Carcinogens. (ROC) 75-07-0
71-43-2
Notice Draft Toxicological Review of Methanol (Non-Cancer) in Support of Summary Information on the Integrated Risk Information System (IRIS) EPA is announcing a 60-day public comment period and listening session for the external review draft human health assessment titled, ‘‘Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)’’ (EPA/635/R–11/001). The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination.

April 18, 2011 -- 76 FR 21736
A National Toxicology Program report recommended performing pathology reviews to resolve differences of opinion in the diagnoses of certain tumors reported in a Ramazzini Institute methanol research study. This study was cited and used to support some of the conclusions in the draft IRIS Methanol Toxicological Review. Following the report from the National Toxicology Program, EPA placed the external peer review of the draft IRIS Methanol Toxicological Review on hold. (IRIS) NA
Final Rule 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.

March 30, 2011 -- 76 FR 17556
National Toxicology Program (NTP); Technical Report Series No. 11. (TR-11) 178949–82–1
Notice 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.

February 11, 2011 -- 76 FR 7841
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.
N/A
Final Rule (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.

February 04, 2011 -- 76 FR 6347
NTP tested trisodium ethylenediaminetetraacetate trihydrate (EDTA)in mice and rats and it showed no carcinogenic potential. Since (S,S)-ethylenediamine disuccinic acid trisodium salt is similar to EDTA, (S,S)-EDDS is not likely to be carcinogenic to humans at low doses. (TR-11) (TS) 178949–82–1
Proposed 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.

April 22, 2010 -- 75 FR 20942
EPA believes that saccharin and its salts, based on the results of the latest reviews of the available scientific information performed by NTP and IARC, do not pose a present or potential risk of causing toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms. (ROC) 81-07-2
Proposed 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.

April 06, 2010 -- 75 FR 17333
These 16 chemicals have been classified by the NTP in their Report on Carcinogens (ROC) as "reasonably anticipated to be a human carcinogen."
1-Amino-2,4- Dibromoanthraquinone (CAS No. 81-49-2)
2,2-bis(Bromomethyl)-1,3- propanediol (CAS No. 3296-90-0)
Furan (CAS No. 110-00-9)
Glycidol (CAS No. 556-52-5)
Isoprene (CAS No. 78-79-5)
Methyleugenol (CAS No. 93-15-2)
1,6-Dinitropyrene (CAS No. 42397-64-8)
1,8-Dinitropyrene (CAS No. 42397-65-9)
6-Nitrochrysene (CAS No. 7496-02-8)
4-Nitropyrene (CAS No. 57835-92-4)
o-Nitroanisole (CAS No. 91-23-6)
Nitromethane (CAS No. 75-52-5)
Phenolphthalein (CAS No. 77-09-8)
Tetrafluoroethylene (CAS No. 116-14-3)
Tetranitromethane (CAS No. 509-14-8)
Vinyl Fluoride (CAS No. 75-02-5)
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
Proposed 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.

March 26, 2010 -- 75 FR 14769

Acetaldehyde, benzene, 1,3-butadiene, alcoholic beverages, and naphthalene are reasonably anticipated to be a human carcinogen by the U.S. Department of Health and Human Services National Toxicology Program 12th Report on Carcinogens. (ROC)

75-07-0
71-43-2
106-99-0
91-20-3

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice of Petition Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives.

January 04, 2016 -- 81 FR 42
The petitioners cite, as evidence, conclusions by the National Toxicology Program, the International Agency for Research on Cancer, and the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment.  The petitioners also include results from an observational epidemiology study in humans exposed to styrene and a number of long-term, animal feeding studies conducted on each of the seven additives to support their request. 100-42-5
Proposed Rule 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.

May 01, 2015 -- 80 FR 25166
Dermal carcinogenicity data have been obtained from studies where alcohol was used as a vehicle control in 2-year studies. For example, a study performed by the National Toxicology Program (NTP) evaluated the carcinogenic potential of diethanolamine by the dermal route of administration in rats and mice (Ref.
130).

Another study performed by the NTP evaluated the carcinogenic potential of benzethonium chloride by the dermal route of administration in rats and mice (Ref. 131). Each species had a vehicle control group that was treated with 95 percent alcohol only. The rats and mice were treated for 5 days per week for 103 weeks. There was no evidence of an increased incidence of skin tumors in the alcohol-treated rats or mice.

National Toxicology Program, ‘‘TR 478: Toxicology and Carcinogenesis Studies of Diethanolamine in F344/N Rats and B6C3F1 Mice,’’ 1999.

National Toxicology Program, ‘‘NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CAS No. 121–54–0) in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ National Toxicology Program Technical Report Series, 438:1–220, 1995.

National Toxicology Program, ‘‘TR 510: Toxicology and Carcinogenesis Studies of Urethane, Ethanol, and Urethane/Ethanol in B6C3F1 Mice,’’ 2004.

National Toxicology Program, ‘‘NTP: Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol in F3441N Rats and B6C3F1 Mice, Technical Report Series, No. 330,’’ 1988.
121-54-0
51-79-6
64-17-5
136-77-6
Notice 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.

November 14, 2014 -- 79 FR 68210

SUPPLEMENTARY INFORMATION:

Title: Qualified Products Lists for Fire Chemicals for Wild Land Fire Management. OMB Number: 0596–0182. Expiration Date of Approval: January 31, 2015. Type of Request: Extension with no revision.

• National Toxicology Program (NTP) ‘‘Annual Report on Carcinogens’’.

Proposed Rule 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.

August 22, 2014 -- 79 FR 49729
Furthermore, we anticipate that the proposal to eliminate the codified GST regulations would encourage the implementation of the principles of the ‘‘3Rs,’’ to reduce, refine, and replace animal use in testing, thus addressing the need to minimize the use of animals in such testing and promoting more humane, appropriate, and specific test methods for assuring the safety of biological products.

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 (42 U.S.C. 2851–3). Additional information on the Federal Government’s implementation of the principles of the 3Rs may be found at the ICCVAM Web site at http://ntp.niehs.nih.gov/go/iccvam.
Proposed 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.

December 17, 2013 -- 78 FR 76444
Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol (CAS No. 136-77-6) in F344/N Rats and B6C3F1 Mice (Gavage Studies).  Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of 4-hexylresorcinol for male or female F344/N rats.  There was equivocal evidence of carcinogenic activity of 4-hexylresorcinol for male B6C3F1 mice.  There was no evidence of carcinogenic activity for female B6C3F1 mice.  (TR-330, 1988). 136-77-6
Final Rule 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.

December 06, 2013 -- 78 FR 73434
Carcinogenesis Bioassay of Gum Arabic (CAS No. 9000-01-5) in F344 Rats and B6C3F1 Mice (Feed Study). Under the conditions of this bioassay, gum arabic was not carcinogenic for F344 rats or B6C3F1 mice of either sex.  (TR-227, 1982).
Notice 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).

April 03, 2012 -- 77 FR 20034
For establishing the list of harmful and potentially harmful constituents in tobacco products and smoke, part of the criteria used were constituents identified by the National Toxicology Program as known or probable human carcinogens. N/A
Notice 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).

February 23, 2012 -- 77 FR10754
NTP Work Cited: NTP 2-year rodent bioassay of cumene showed clear evidence of carcinogenicity (TR-452). 98-82-8
Final Rule 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).

June 17, 2011 -- 76 FR 35620
The Report on Carcinogens indicates that UVA and UVB radiation across the spectrum are known human carcinogens, but either UVA or UVB radiation alone is reasonably anticipated to be a human carcinogen. Cited in the National Toxicology Program’s Report on Carcinogens. (ROC) N/A
Notice 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 http://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.

April 05, 2010 -- 75 FR 17145
National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction. NTP–CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08–5994. September 2008. 80-05-7
Notice Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority The Food and Drug Administration (FDA) is announcing the reorganization of the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This notice was previously published in the Federal Register of August 18, 2009, but it contained several errors. For the convenience of the reader, the reorganization is published again in its entirety.

February 19, 2010 -- 75 FR 7490
Office of Science: Serves as principal authority and provides leadership for the Center’s participation in the National Toxicology Program (NTP). NA

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National Academies of Sciences, Engineering, and Medicine (NAS)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice 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.

January 05, 2017 --
NTP (National Toxicology Program). 2004. A National Toxicology Program for the 21st Century: A Roadmap for the Future [online].

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National Institute for Occupational Safety and Health (NIOSH)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Public Meeting and Request for Information: Carcinogen and Recommended Exposure Limit (REL) Policy Assessment The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a public meeting to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. NIOSH requested initial input on these issues (including answers to five questions listed below under SUPPLEMENTARY INFORMATION), to be submitted to NIOSH Docket number 240.

November 17, 2011 -- 76 FR 71346
In contrast to the current NIOSH Carcinogen Policy, the National Toxicology Program allows for a more differential classification. NA
Notice Request for Information: Announcement of Carcinogen and Recommended Exposure Limit (REL) Policy Assessment The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. As part of this effort, NIOSH is requesting initial input on these issues (including answers to the 5 questions in the following section), to be submitted to the NIOSH Docket number 240, for a comment period lasting through September 22, 2011. This information will be taken under consideration and used to inform NIOSH efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer.

August 23, 2011 -- 76 FR 52664
The National Toxicology Program's carcinogen classification allows for a more differential categorization than NIOSH's definition. N/A

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National Resources Defense Council (NRDC)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice 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.

June 10, 2015 -- NRDC
NTP, Technical Report on the Toxicology and Carcinogenesis Studies of Benzophenone (CAS No 119-61-9) in F33/N Rats and B6C3F1 Mice, 2006. See http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr533/index.html

NTP, Final Report on Carcinogens Background Document for Methyleugenol, 2000. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/m/methyleugenol/summary/index.html

NTP, Carcinogenesis Studies of Methyl Eugenol (CAS No. 93-15-2) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr491/index.html

NTP, Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2010. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr557/index.html

NTP, Toxicology and Carcinogenesis Studies of Pulegone (CAS No. 89-82-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2011. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr500580/listedreports/tr563/index.html

NTP, Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats, and B6C3F1 Mice (Drinking Water Studies), 2000. http://ntp.niehs.nih.gov/results/pubs/longterm/reports/longterm/tr400499/abstracts/tr470/index.html

NTP, Report on Carcinogens, Thirteenth Edition, Styrene, 2014. See http://ntp.niehs.nih.gov/go/roc13

NTP, Final Report on Carcinogens Background Document for Styrene, 2008. See http://ntp.niehs.nih.gov/pubhealth/roc/listings/s/styrene/summary/index.html

NTP, Technical Report on the Toxicology and Carcinogenesis Studies of 2,4-Hexadienal (89% trans,trans isomer, CAS No. 142-83-6; 11% cis,trans isomer) in F344/N Rats and B6C3F1 Mice (Gavage Studies), 2003. See http://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr509.pdf

119-61-9
140-88-5
93-15-2
123-35-3
89-82-7
110-86-1
100-42-5
142-83-6

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Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed rule; Request for Comments 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.

August 07, 2015 -- 80 FR 47566
In brief, IARC determined beryllium and its compounds to be carcinogenic to humans (Group 1 category), while EPA considers beryllium to be a probable human carcinogen (EPA, 1998), and the National Toxicology Program (NTP) has determined beryllium and its compounds to be known carcinogens (NTP, 2014).

 

Other scientific organizations, including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium

 

National Toxicology Program. (1993). Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807–96–6)(NonAsbestiform) in F344/N Rats and B6C3F1 Mice (Inhalation Studies).

 

National Toxicology Program. (1999). Final Report on Carcinogens: Background Document for Beryllium and Beryllium Compounds. 

 

National Toxicology Program. (2002). Tenth report on carcinogens. U.S. Department of Health and Human Services, National Toxicology Program, Research Triangle Park, NC. 

National Toxicology Program. (2014). Report on Carcinogens, Thirteenth Edition. Beryllium and Beryllium compounds. CAS No. 7440–41–7.
14807-96-6
7440-41-7
Request for Information 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.

October 10, 2014 -- 79 FR 61384

Question IV.A.3: OSHA is considering greater reliance on peer-reviewed toxicological evaluations by other Federal agencies, such as NIOSH, EPA, ATSDR, NIEHS and NTP for hazard identification and dose-response analysis in the observed range. What advantages and disadvantages would result from this approach and could it be used in support of the PEL update process?

 

4. Use of Systems Biology and Other Emerging Test Data in Risk Assessment Toxicity testing is undergoing transformation from an approach primarily based on pathological outcomes in experimental animal studies to a more predictive paradigm that characterizes critical molecular/cellular perturbations in toxicity pathways using in vitro test systems.  The paradigm shift is being largely driven by the technological advances in molecular systems biology such as the use of high throughput screening (HTS) assays, new computational methods to predict chemical properties, and computer models able to associate molecular events with a biological response. The vision, strategies, and frameworks for applying the new toxicity data to risk-based decision making are laid out in landmark reports by the National Research Council (NRC, 2009; Ex. #24, NRC, 2007; Ex. #25). A collaborative Federal initiative known as ‘‘Tox21’’ has been established between the National Toxicology Program (NTP), the EPA Office of Research and Development, the NIH

Chemical Genomics Center (NCGC), and the Food and Drug Administration (FDA) to collaborate on development, validation, and translation of innovative HTS methods to characterize key steps in toxicity pathways (NTP, 2013; Ex. #40). Tox21 has already screened over a 1000 compounds in more than 50 quantitative HTS assays that have been made available to the scientific community through publically accessible databases (e.g., EPA ACToR, NTP CEBS). EPA has launched a program, known as ‘‘NexGen’’, to implement the NRC vision and advance the next generation of risk assessment (EPA, 2013b; Ex. #41). NexGen is a partnership among EPA, NTP, NCGC, AND FDA, along with ATSDR and California’s EPA Office of Environmental Health Hazard Assessment. The objectives of NexGen are to pilot the new NRC risk assessment framework, refine existing bioinformatics systems, and develop specific prototype health risk assessments. These objectives are expected to be achieved through an iterative development process that includes discussion with scientists, risk managers, and stakeholders

 

#40: National Toxicology Program (NTP). (2013). High Throughput Screening

Initiative. Retrieved from: http://ntp.niehs.nih.gov/go/28213.

Proposed 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.

September 12, 2013 -- 78 FR 56274
National Toxicology Program Report on Carcinogens (ROC):  Silica crystalline (respirable size) is known to be a human carcinogen. None assigned
Final Rule 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.

March 26, 2012 -- 77 FR 17574
Used the classification listing that NTP uses on Safety Data Sheets; based classification to determine carcinogenicity on the National Toxicology Program’s Report on Carcinogens (ROC). NA

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Office of Lead Hazard Control and Healthy Homes (HUD)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule 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.

September 01, 2016 -- 81 FR 60304
HHS, National Institute of Environmental Health Sciences, National Toxicology Program. NTP Monograph on Health Effects of Low-Level Lead. NIH Publication No. 12–5996. June 13, 2012. 7439-92-1

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United States Department of Agriculture (USDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice 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.

September 21, 2011 -- 76 FR 58462
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC) NA
Notice 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.

September 21, 2011 -- 76 FR 58460
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC) N/A
Notice 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.

September 11, 2011 -- 76 FR 58461
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC) NA

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