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Regulatory Actions for Year 2003


California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Chemical Listed Effective November 14, 2003 as Known to the State of California to Cause Cancer: Fumonisin B1 The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding fumonisin B1 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 fumonisin B1 is effective November 14, 2003 Toxicological Endpoint: Cancer

November 14, 2003 -- Proposition 65
National Toxicology Program (NTP, 2001). Toxicology and Carcinogenesis Studies of Fumonisin B1 (CAS No. 116355-83-0) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 496, NIH Publication No. 01-3955 116355-83-0
Notice Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

September 26, 2003 -- Public Health Goals
NTP (1983). Lifetime carcinogenesis studies of amosite asbestos (CAS No. 12172-73-5) in Syrian golden hamsters (feed studies). Tech report series No. 249.

NTP (1985). Toxicology and carcinogenesis studies of chrysotile asbestos (CAS No. 12001-29-5) in F344/N rats (feed studies ). Tech report series No. 295.

NTP (1988). Toxicology and carcinogenesis studies of crocidolite asbestos (CAS No. 12001-28-4) in F344/N rats (feed studies). Tech report series No. 280.

NTP (1990a). Lifetime carcinogenesis studies of chrysotile asbestos (CAS No. 12001- 29-5) in Syrian golden hamsters (feed studies). Tech report series No. 246.

NTP (1990b). Toxicology and carcinogenesis series of amosite asbestos in F344/N rats. Tech report series No. 279.

NTP (1990c). Technical Report on the toxicology and carcinogenesis studies of tremolite (CAS No. 14567-73-8) in Fischer 344 rats (feed studies). Tech report series No. 277.

NTP (2000). Asbestos. CAS No. 1332-21-4. Ninth Report on Carcinogens

1332-21-4
Notice Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

September 26, 2003 -- Public Health Goals
NTP (1982). Carcinogenesis bioassay of di(2-ethylhexyl)adipate (CAS No. 103-23-1) in F344 Rats and B6C3F1 Mice (Feed Study). Technical Report, Series No. 212. 103-23-1
Notice Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

September 26, 2003 -- Public Health Goals
NTP (1985). Technical Report on the Toxicology and Carcinogenesis Studies of Chlorobenzene (CAS No. 108-90-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP TR 261. 108-90-7
Notice Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water.

September 26, 2003 -- Public Health Goals
NTP (1982). Carcinogenesis bioassay of 1,2-dibromoethane in F344 rats and B6C3F1 mice (inhalation study). Technical report No. 210. 106-93-4
Notice Announcement of Publication of the Final Technical Support Documents for Public Health Goals for 11 Chemicals in Drinking Water The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announces the availability of the final technical support documents for a Public Health Goal (PHG) for each of the following eleven (11) chemicals in drinking water. (barium)

September 26, 2003 -- Public Health Goals
NTP (1994). Technical report on the toxicology and carcinogenesis studies of barium chloride dihydrate (CAS No. 10326-27-9) in F344/N rats and B6C3F1 mice. TR-432 10326-27-9
Notice Chemical Listed Effective March 14, 2003 as Known to the State of California to Cause Cancer: Strong Inorganic Acid Mists Containing Sulfuric Acid The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding strong inorganic acid mists containing sulfuric acid 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 strong inorganic acid mists containing sulfuric acid is effective March 14, 2003. Toxicological Endpoint: Cancer

March 14, 2003 -- Proposition 65
National Toxicology Program (NTP, 2000). Report on Carcinogens, Ninth Edition: Carcinogen Profiles. U.S. Department of Health and Human Services, Public Health Service, NTP, Research Triangle Park, NC. 7664-93-9 (Mists containing)

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed List of Hazardous Air Pollutants, Petition Process, Lesser Quantity Designations, Source Category List The EPA proposes to amend the list of hazardous air pollutants contained in section 112(b)(1) of the Clean Air Act by removing ethylene glycol monobutyl ether from the group of glycol ethers.

November 21, 2003 -- 68 FR 65648
The EPA used data from the NTP's 2-year inhalation study (TR-484) in considering the removal of EGBE from the list of hazardous air pollutants.
111-76-2
Notice National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule The EPA is proposing maximum contaminant level goals (MCLGs) for chloroform, monochloroacetic acid and trichloroacetic acid;National Primary Drinking Water Regulations for total trihalomethanes and haloacetic acids; and revisions to the reduced monitoring requirements for bromates.

August 18, 2003 -- 68 FR 49548
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Bromodichloromethane (TR-321), Tribromomethane (TR-350), and Monochloroacetic Acid (TR-396) in determining the MCLGs for water disinfection byproducts. 79-11-8
75-25-2
75-27-4

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents, N-Methylpyrrolidone and Tetrahydrofuran. The FDA is proposing a rule that would establish conditions under which over-the-counter drug products for the reduction or prevention of dental plaque and gingivitis are generally recognized as safe and effective and not misbranded.

May 29, 2003 -- 68 FR 32232
The NTP 13-week Stannous Chloride studies were used to develop the existing safety factor for potential exposure to Stannous salts from use of a dentifrice containing stannous fluoride. (TR-231) 7772-99-8
Final Rule New Animal Drugs: Phenylbutazone; Extralabel Animal Drug Use; Order of Prohibition The FDA is prohibiting the extralabel use of phenylbutazone animal and human drugs in female dairy cattle 20 months of age or older. The extralabel use presents a risk to the public health.

February 28, 2003 -- 68 FR 9528
The FDA has determined that the extralabel use of phenylbutazone presents a risk to the public health. The FDA's conclusion is based on available toxicology data including data from the NTP Toxicology and Carcinogenesis Studies of Phenylbutazone (TR-367) and the NTP genotoxicity tests. 50-33-9

Mine Safety and Health Administration (MSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Proposed Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners The Department of Labor is proposing revising the existing diesel particulate matter (DPM) interim concentration limit.

August 14, 2003 -- 68 FR 48668
A published review of the particulate inhalation studies conducted by the NTP was used to update the toxicological effects of DPM exposure.