National Toxicology Program

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

Regulatory Actions for Year 2015




California Office of Environmental Health Hazard Assessment (COEH)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice NOTICE OF PROPOSED RULEMAKING AND ANNOUNCEMENT OF PUBLIC HEARING TITLE 27, CALIFORNIA CODE OF REGULATIONS PROPOSED ADOPTION OF SECTION 25205 PROPOSITION 65 LEAD AGENCY WEBSITE This regulation would establish the framework for a website operated by OEHHA that would provide supplemental information to the public about potential exposures to Proposition 65 listed chemicals.

January 12, 2015 --
REFERENCES FOR SECTION 25602
US Department of Health and Human Services, National Toxicology Program. 13th Report on Carcinogens (October 2014). Available at http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html.
N/A
Notice CHEMICAL LISTED EFFECTIVE MARCH 27, 2015 AS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER: BETA-MYRCENE Effective March 27, 2015,the Office of Environmental Health Hazard Assessment (OEHHA) is adding beta-myrcene(CAS No. 123-35-3)to the list of chemicals known to the state to cause cancer for purposes of Proposition 65

March 24, 2015 --

In 2010, the NTP published a report on beta-myrcene (β‑myrcene), entitled Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies), that concludes that the chemical causes cancer (NTP, 2010).  This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.

NTP (2010). Toxicology and Carcinogenesis Studies of β-Myrcene (CAS No. 123-35-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Technical Report Series No. 557, NIH Publication No. 10-5898. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

123-35-3
Notice NOTICE OF INTENT TO LIST: STYRENE The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list styrene as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986.

February 27, 2015 --

In 2011, NTP published the Twelfth Edition of the Report on Carcinogens (NTP, 2011). This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations for styrene. NTP concluded that styrene is “reasonably anticipated to be a human carcinogen based on limited evidence of carcinogenicity from studies in humans, sufficient evidence of carcinogenicity from studies in experimental animals, and supporting data on mechanisms of carcinogenesis” (emphasis in original). OEHHA is relying on NTP’s discussion of data and conclusions in the report that styrene causes cancer.

National Toxicology Program (NTP, 2011). Report on Carcinogens, Twelfth Edition, U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, North Carolina, page 383-391. [Most recent edition of the Report on Carcinogens available at URL: http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html.]

100-42-5

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice of availability, and request for comments Draft Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability and Request for Comment EPA is announcing the availability of three draft test guidelines for public review and comment that are being added to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines.” The draft guidelines relate to the following three non-mammalian species tests identified under Tier 2 of the Endocrine Disruptor Screen Program (EDSP): Japanese quail 2-generation reproduction test; Medaka extended 1-generation reproduction test; and Larval amphibian growth and development assay. These draft test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducing the test, and are also used by EPA, the public, and companies that submit data to EPA.

January 30, 2015 -- 80 FR 5107
EPA followed the general validation principles of the Organization for Economic Co-Operation and Development (OECD) and the Intergovernmental Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the development of the four non-mammalian Tier 2 tests.
Proposed Rule Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule Under the Toxic Substance Control Act (TSCA), EPA is proposing significant new use rule (SNUR) for 2,4- toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply." "Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs."

January 15, 2015 -- 80 FR 2068
TDI has also been classified by the European Commission (EC) as Category 3 for carcinogenicity (‘‘causes concerns for humans owing to possible carcinogenic effects’’) (Ref. 16) and by the United States National Toxicology Program (NTP) as ‘‘reasonably anticipated to be a human carcinogen’’ (Ref. 17). 9019-85-6
9017-01-0
26747-90-0
26603-40-7
26603-40-7
91-08-7
584-84-9
26471-62-5

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