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 (OEHHA)

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 -- Proposition 65
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 -- Proposition 65

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 -- Proposition 65

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.]

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Notice Meeting Synopsis and Slide Presentation for the Carcinogen Identification Committee Meeting Held on November 19,2014 The Office of Environmental Health Hazard Assessment (OEHHA) convened a meeting of the Proposition 65 Carcinogen Identification Committee (CIC) on November 19, 2014, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. The Committee considered whether or not dibenzanthracenes (as a chemical group), dibenz[a,c]anthracene, dibenz[a,j]anthracene, and N-nitrosomethyl-n-alkylamines with alkyl chain lengths of 3 through 12 and 14 carbons should be listed under Proposition 65 as known to the state to cause cancer. The Committee also heard staff updates regarding Proposition 65 activities. A summary of the meeting is provided below.

April 20, 2015 -- Proposition 65

DB [a,h]A: NTP (1981): “Reasonably anticipated to be a human carcinogen”

53-70-3
Notice Hazard Identification Materials for Consideration of the Female Reproductive Toxicity of Bisphenol A Bisphenol A (BPA) will be considered for listing at the next meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) scheduled for May 7, 2015 in Sacramento. At this meeting,, the DARTIC will consider whether BPA "has been clearly shown through scientifically valid testing according to generally accepted principles to cause female reproductive toxicity".

April 23, 2015 -- Proposition 65

NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A (2008) [Attachment to OEHHA, 2009]

 

National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2008). "NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A." NTP, US Department of Health and Human Services, Research Triangle Park, NC, NIH Publication No. 08-5994.

80-05-7
Notice Proposed Reference Exposure Levels for Carbonyl Sulfide – SRP Review Drafts The Office of Environmental Health Hazard Assessment (OEHHA) is releasing a draft document for review by the State's Science Review Panel on Toxic Air Contaminants (SRP). The SRP review draft document summarizes the toxicity and derivation of Reference Exposure Levels (RELs) for Carbonyl Sulfide. This document is for review and comment by the Science Review Panel at their meeting on June 19, 2015. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse non–cancer health effects for specified exposure durations in the general population, including sensitive subpopulations.

May 21, 2015 --
The National Toxicology Program (NTP) studied 4 strains of mutant Salmonella (TA97,
TA98, TA100, and TA1535) in the Ames test and used from 0.58 to 2.89 µg COS per
test plate with and without induced liver extract from rats or hamsters. They reported a
weakly positive response based on positive results in one strain (TA97) (NTP, 1995).

NTP. (1995). Genetic Toxicology - Bacterial Mutagenicity. NTP Study ID: A35125.
CEBS Accession Number: 002-01834-0001-0000-9 from
http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=A35125.
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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
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Proposed Rule Addition of 1-Bromopropane; Community Right-To-Know Toxic Chemical Release Reporting The Environmental Protection Agency (EPA) is proposing to add 1-bromopropane to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. 1-Bromopropance has been classified by the National Toxicology Program in their 13th Report on Carcinogens as “reasonably anticipated to be human carcinogen.” EPA believes that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. Based on a review of the available production and use information, 1-bromopropane is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds.

April 15, 2015 -- 80 FR 20189

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709. (http://ntp.niehs.nih. gov/pubhealth/roc/roc13/index.html)

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Introduction section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Process for Preparation of the Report on Carcinogens section. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, Research Triangle Park, NC 27709.

 

NTP, 2013. Report on Carcinogens Monograph on 1-Bromopropane. Office of the Report on Carcinogens, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, U.S. Department of Health and Human Services. NIH Publication No. 13–5982, September 25, 2013

 

 

NTP, 2014. National Toxicology Program. Report on Carcinogens, Thirteenth Edition, Profile for 1-Bromopropane. Released October 2, 2014. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Rule Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.

May 01, 2015 -- 80 FR 25166
Dermal carcinogenicity data have been obtained from studies where alcohol was used as a vehicle control in 2-year studies. For example, a study performed by the National Toxicology Program (NTP) evaluated the carcinogenic potential of diethanolamine by the dermal route of administration in rats and mice (Ref.
130).

Another study performed by the NTP evaluated the carcinogenic potential of benzethonium chloride by the dermal route of administration in rats and mice (Ref. 131). Each species had a vehicle control group that was treated with 95 percent alcohol only. The rats and mice were treated for 5 days per week for 103 weeks. There was no evidence of an increased incidence of skin tumors in the alcohol-treated rats or mice.

National Toxicology Program, ‘‘TR 478: Toxicology and Carcinogenesis Studies of Diethanolamine in F344/N Rats and B6C3F1 Mice,’’ 1999.

National Toxicology Program, ‘‘NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride (CAS No. 121–54–0) in F344/N Rats and B6C3F1 Mice (Dermal Studies),’’ National Toxicology Program Technical Report Series, 438:1–220, 1995.

National Toxicology Program, ‘‘TR 510: Toxicology and Carcinogenesis Studies of Urethane, Ethanol, and Urethane/Ethanol in B6C3F1 Mice,’’ 2004.

National Toxicology Program, ‘‘NTP: Toxicology and Carcinogenesis Studies of 4-Hexylresorcinol in F3441N Rats and B6C3F1 Mice, Technical Report Series, No. 330,’’ 1988.
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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.