National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/719274

Regulatory Actions for Year 2010




California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Announcement of Publication of the Final Public Health Goals for Benzo(A)Pyrene, Methoxychlor, and TCDD (Dioxin) In Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the publication of the final technical support documents for the Public Health Goals (PHGs) for benzo(a)pyrene, methoxychlor, and TCDD (dioxin) in drinking water. The PHG for benzo(a)pyrene is established at 0.007 parts per billion (ppb), based on carcinogenic effects in rats and mice. The PHG for methoxychlor is established at 0.09 ppb, based on effects in male offspring of female mice treated with methoxychlor during pregnancy. The PHG for TCDD is established at 0.00005 parts per trillion (ppt), based on tumors in multiple sites in female rats.

September 16, 2010 -- Proposition 65
NTP (1982a). Bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin for possible carcinogenicity (gavage study). TR 201. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

NTP (1982b). Carcinogenesis bioassay of 2,3,7,8-tetrachlorodibenzo-p-dioxin (CAS no. 1746-01-6) in Osborne-Mendel rat and B6C3F1 mice (gavage study). TR 109. National Toxicology Program, DHHS, Public Health Service, Research Triangle Park, NC.

NTP (1984). Report of the NTP ad hoc panel on chemical carcinogenesis testing and evaluation. Board of Scientific Counselors. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

NTP (2001). Report on Carcinogens, Ninth Edition. National Toxicology Program, U.S. DHHS, Public Health Service, Research Triangle Park, NC.

NTP (2004). Toxicology and carcinogenesis studies of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in female Harlan Sprague-Dawley rats (gavage study). TR 521. NIH publication No. 04-4455. National Toxicology Program, Public Health Service, National Institutes of Health, Research Triangle Park, NC.

NTP/NIEHS (1989). Symposium on Significance of Foci of Cellular Alteration in the Rat Liver. Toxicol Pathol 17:557-735.
Final Rule Bromochloroacetic Acid (CAS No. 5589-96-8), Cumene (CAS No. 98-82-8) and Diclofop-Methyl (CAS No. 51338-27-3) Listed as Known to the State to Cause Cancer The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding Bromochloroacetic acid (CAS No. 5589-96-8), Cumene (CAS No. 98-82-8) and Diclofop-methyl (CAS No. 51338-27-3) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of bromochloroacetic acid, cumene and diclofop-methyl is effective April 6, 2010.

April 02, 2010 -- Proposition 65
National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Cumene (CAS No. 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 542.

National Toxicology Program (NTP, 2009). Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 549.

5589-96-8
98-82-8

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Hazardous Waste Management System; Identification and Listing of Hazardous Waste; Removal of Saccharin and Its Salts From the Lists of Hazardous Constituents, Hazardous Wastes, and Hazardous Substances The Environmental Protection Agency (EPA or the Agency) is proposing to amend its regulations under the Resource Conservation and Recovery Act (RCRA) to remove saccharin and its salts from the lists of hazardous constituents and commercial chemical products, which are hazardous wastes when discarded or intended to be discarded. EPA is also proposing to amend the regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to remove saccharin and its salts from the list of hazardous substances. This proposed rule is in response to a petition submitted to EPA by the Calorie Control Council (CCC), to remove saccharin and its salts from the above lists. EPA is proposing to grant CCC's petition based on a review of the evaluations conducted by key public health agencies concerning the carcinogenic and other potential toxicological effects of saccharin and its salts, as well as EPA’s own assessment of the waste generation and management information for saccharin and its salts, which demonstrate that saccharin and its salts do not meet the criteria in the hazardous waste regulations for remaining on EPA's lists of hazardous constituents, hazardous wastes, and hazardous substances.

April 22, 2010 -- 75 FR 20942
EPA believes that saccharin and its salts, based on the results of the latest reviews of the available scientific information performed by NTP and IARC, do not pose a present or potential risk of causing toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms. (ROC) 81-07-2
Proposed Addition of National Toxicology Program (NTP) Carcinogens; Community Right-to-Know Toxic Chemical Release Reporting EPA is proposing to add sixteen (16) chemicals 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 of 1990.

April 06, 2010 -- 75 FR 17333
These 16 chemicals have been classified by the NTP in their Report on Carcinogens (ROC) as "reasonably anticipated to be a human carcinogen."
1-Amino-2,4- Dibromoanthraquinone (CAS No. 81-49-2)
2,2-bis(Bromomethyl)-1,3- propanediol (CAS No. 3296-90-0)
Furan (CAS No. 110-00-9)
Glycidol (CAS No. 556-52-5)
Isoprene (CAS No. 78-79-5)
Methyleugenol (CAS No. 93-15-2)
1,6-Dinitropyrene (CAS No. 42397-64-8)
1,8-Dinitropyrene (CAS No. 42397-65-9)
6-Nitrochrysene (CAS No. 7496-02-8)
4-Nitropyrene (CAS No. 57835-92-4)
o-Nitroanisole (CAS No. 91-23-6)
Nitromethane (CAS No. 75-52-5)
Phenolphthalein (CAS No. 77-09-8)
Tetrafluoroethylene (CAS No. 116-14-3)
Tetranitromethane (CAS No. 509-14-8)
Vinyl Fluoride (CAS No. 75-02-5)
81-49-2
3296-90-0
110-00-9
556-52-5
78-79-5
93-15-2
42397-64-8
42397-65-9
7496-02-8
57835-92-4
91-23-6
75-52-5
77-09-8
116-14-3
509-14-8
75-02-5
Proposed Testing of Certain High Production Volume Chemicals; Third Group of Chemicals EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers, and processors of certain high production volume (HPV) chemicals to conduct testing to obtain screening level data for health and environmental effects and chemical fate.

March 26, 2010 -- 75 FR 14769
Acetaldehyde, benzene, 1,3-butadiene, alcoholic beverages, and naphthalene are reasonably anticipated to be a human carcinogen by the U.S. Department of Health and Human Services National Toxicology Program 12th Report on Carcinogens. (ROC) 75-07-0
71-43-2
106-99-0
91-20-3

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Food Additives; Bisphenol A; Availability The Food and Drug Administration (FDA) announces the availability of five documents related to FDA’s continuing assessment of Bisphenol A (BPA) and solicits public comments on the four documents prepared by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.

April 05, 2010 -- 75 FR 17145
National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction. NTP–CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08–5994. September 2008. 80-05-7
Notice Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority The Food and Drug Administration (FDA) is announcing the reorganization of the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This notice was previously published in the Federal Register of August 18, 2009, but it contained several errors. For the convenience of the reader, the reorganization is published again in its entirety.

February 19, 2010 -- 75 FR 7490
Office of Science: Serves as principal authority and provides leadership for the Center’s participation in the National Toxicology Program (NTP). NA

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