National Toxicology Program

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

Regulatory Actions for Year 2016




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.