National Toxicology Program

National Toxicology Program

Regulatory Actions for Year 2017

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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.

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.

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.

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.


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