National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/809376

Regulatory Actions for Year 2017




California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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

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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

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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.

7775-09-9
631-64-1
5589-96-8
71133-14-7
7681-49-4
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

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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.