National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/regact

Regulatory Actions for Year 2016




California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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. 

140-11-4

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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

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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.