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Annual Report for Fiscal Year 2018

Annual Report for Fiscal Year 2018
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https://ntp.niehs.nih.gov/go/860666

NTP Public Health Impact

Federal and state regulatory agencies use NTP study data and recommendations in considering the need to regulate and test specific chemicals for the protection of human health. The NTP data and recommendations used by other agencies in FY 2018 are listed below. A full listing is available on the NTP website.

Use of NTP Study Data or Recommendations by Federal and State Health Regulatory and Research Agencies in FY 2018

Notice

Summary of Notice

NTP Information Cited

Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates, Final Rule

October 27, 2017

82 FR 49938
The U.S. Consumer Product Safety Commission issued a final rule prohibiting children’s toys and child care articles that contain concentrations of more than 0.1% of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). NTP (2015). Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration.

NTP (2016). 14th Report on Carcinogens.
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings: Proposed Additions to the NIOSH Hazardous Drug List 2018, Notice of Draft Document Available for Public Comment

January 14, 2018

83 FR 6563
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announced the availability for public comment of proposed additions to the list of antineoplastic and other hazardous drugs in healthcare settings, as well as NIOSH Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. NTP (2016). 14th Report on Carcinogens.
Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Bromodichloroacetic Acid

January 26, 2018

Proposition 65
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) proposed to adopt a Proposition 65 No Significant Risk Level of 0.95 micrograms per day for bromodichloroacetic acid by amending Title 27, California Code of Regulations, section 25705(b).

 

NTP (2015). Toxicology Studies of Bromodichloroacetic Acid (CAS No. 71133-14-7) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Bromodichloroacetic Acid in F344/NTac Rats and B6C3F1/N Mice (Drinking Water Studies). TR 583.
Notice of Intent to List: TRIM VX

January 26, 2018

Proposition 65
The California Environmental Protection Agency’s OEHHA proposed to list TRIM VX as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. NTP (2016). NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). TR 591.
Announcement of Second Public Comment Period for the Draft Technical Support Document on the Proposed Updates of the Public Health Goals for Nitrate and Nitrite in Drinking Water

February 09, 2018

Proposition 65
The California Environmental Protection Agency’s OEHHA announced the availability of the revised draft technical support document for the proposed updates of the Public Health Goals for nitrate and nitrite in drinking water.

                                   

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. TR 495.

NTP (2014). 13th Report on Carcinogens.
Amendment to Section 25705 No Significant Risk Level – Glyphosate

April 10, 2018

Proposition 65
On April 6, 2018, the California Office of Administrative Law approved an amendment of Title 27, California Code of Regulations, section 25705, that establishes a No Significant Risk Level of 1100 micrograms per day for glyphosate. NTP (2015). Handbook for Preparing Report on Carcinogens Monographs.
Current Proposition 65 No Significant Risk Levels (NSRLs) Maximum Allowable Dose Levels (MADLs)

April 17, 2018

Proposition 65
Under Proposition 65, California has established Safe Harbor levels, which include NSRLs for cancer-causing chemicals and MADLs for chemicals causing reproductive toxicity, for many listed chemicals. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65. In some instances, enforcement actions might have resulted in negotiated exposure levels relative to specific settlement agreements. NTP (1987). Toxicology and Carcinogenesis Studies of Chlorendic Acid in F344 Rats and B6C3F1 Mice (Feed Studies). TR 304.

NTP (1991). Chemical Status Report.

NTP (1986). Toxicology and Carcinogenesis Studies of C.l. Basic Red 9 Monohydrochloride in F344/N Rats and B6C3F1 Mice (Feed Studies). TR 285.

NTP (1982). Toxicology and Carcinogenesis Studies of D & C Red 9 in F344/N Rats and B6C3F1 Mice (Feed Study). TR 225.

National Cancer Institute (NCI) (1980). Bioassay of 4,4'-Oxydianiline for Possible Carcinogenicity. TR 205.

NTP (1986). Toxicology and Carcinogenesis Studies of Diglycidyl Resorcinol Ether in F344/N Rats and B6C3F1 Mice (Gavage Studies). TR 257.

NTP (1986). Toxicology and Carcinogenesis Studies of Dimethylvinyl Chloride (1-chloro-2-methyl-propene) in F344/N Rats and B6C3F1 Mice (Gavage Studies). TR 316.

NTP (1985). Toxicology and Carcinogenesis Studies of HC Blue 1 in F344/N Rats and B6C3F1 Mice (Feed Studies). TR 271.

NTP (1989). Toxicology and Carcinogenesis Studies of Hexachloroethane in F344/N Rats (Gavage Studies). TR 361.
Notice of Amendment to Section 25705 No Significant Risk Level (NSRL) for Vinylidene Chloride

May 17, 2018

Proposition 65
On May 9, 2018, the California Environmental Protection Agency’s Office of Administrative Law approved an amendment of Title 27, California Code of Regulations, section 25705, which establishes an NSRL for vinylidene chloride of 0.88 micrograms per day. NTP (2015). Toxicology and Carcinogenesis Studies of Vinylidene Chloride (CAS No. 75-35-4) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). TR 582.
Acrylamide

Notice

May 21, 2018

Proposition 65
The California OEHHA published a notice providing information on the existing Proposition 65 listing of Acrylamide. NTP (2016). 14th Report on Carcinogens.
Chemical Listed Effective May 25, 2018 as Known to the State of California to Cause Cancer: TRIM® VX

May 25, 2018

Proposition 65
The California Environmental Protection Agency’s OEHHA added TRIM® VX to the list of chemicals known to the State of California to cause cancer for purposes of Proposition 65. The listing of TRIM® VX was based on formal identification by NTP that the chemical causes cancer. NTP (2016). NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM® VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). TR 591.
Revised Draft Technical Support Document on the Proposed Updates of the Public Health Goals for Cis- and Trans-1,2-Dichloroethylene in Drinking Water

June 01, 2018

Proposition 65
The California Environmental Protection Agency’s OEHHA announced the availability for public comment of the (1) revised draft technical support document for the proposed updates of the Public Health Goals for cis- and trans-1,2-dichloroethylene in drinking water. NTP (2002) NTP Technical Report on the Toxicity Studies of Trans-1,2-dichloroethylene (CAS No. 156-60-5) Administered in Microcapsules in Feed to F344/N Rats and B6C3F1 Mice. TOX 55.
Asbestos; Significant New Use Rule, Proposed Rule

June 11, 2018

40 CFR Part 721
Under the Toxic Substances Control Act (TSCA), EPA proposed a significant new use rule for asbestos as defined under the Asbestos Hazard Emergency Response Act. The proposed significant new use of asbestos (including as part of an article) in manufacturing (including importing) or processing for certain uses identified by EPA as no longer ongoing. NTP (2016). 14th Report on Carcinogens.
Authoritative Bodies Tracking Table, Notice

June 13, 2018

Proposition 65
The California Environmental Protection Agency’s OEHHA revised the table of chemicals considered for addition to the Proposition 65 list.

 

NTP (2014). Toxicology Studies of Cobalt Metal (CAS No. 7440-48-4) in F344/N Rats and B6C3F1/N Mice and Toxicology and Carcinogenesis Studies of Cobalt Metal in F344/NTac Rats and B6C3F1/N Mice (Inhalation Studies). TR 581.

NTP (2016). NTP Technical Report on the Toxicology and Carcinogenesis Studies of Trim VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies) TR 591.
Review of the Dust-Lead Hazard Standards and the Definition of Lead-Based Paint, Proposed Rule

July 02, 2018

83 FR 30889
As part of efforts to reduce childhood lead exposure, EPA evaluated the current dust-lead hazard standards (DLHS) and the definition of lead-based paint (LBP). Based on this evaluation, EPA proposed to lower the DLHS from 40 μg/ft2 and 250 μg/ft2 to 10 μg/ft2 and 100 μg/ft2 on floors and window sills, respectively. EPA proposed no changes to the current definition of LBP due to insufficient information to support such a change. NTP (2012). Health Effects of Low-Level Lead.NTP Monograph.
The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks, Notice of Proposed Rulemaking

August 24, 2018

83 FR 42986
The National Highway Traffic Safety Administration and EPA proposed the “Safer Affordable Fuel-Efficient Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks” (SAFE Vehicles Rule). If finalized, the rule would amend certain existing vehicle emissions standards and establish new standards, all covering model years 2021 through 2026. NTP (2014). 13th Report on Carcinogens.

*CASRN = Chemical Abstracts Service Registry Number