The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act) requires the Governor to publish, and update at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. The Act provides two mechanisms for administratively listing chemicals as known to the State to cause cancer or reproductive toxicity [Health and Safety Code Section 25249.8(b)].

One mechanism by which a chemical is listed is if a body considered to be authoritative by the state’s qualified experts has formally identified it as causing cancer or reproductive toxicity. For carcinogenicity, the US Environmental Protection Agency (US EPA), the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH) have been identified as authoritative bodies for purposes of the Act. At their July 27, 1998, meeting, the state’s qualified experts in the area of reproductive toxicity made changes to the list of institutions considered to be authoritative in the area of reproductive toxicity. The bodies currently designated as authoritative in the area of reproductive toxicity are: US EPA, IARC (for transplacental carcinogenicity only), FDA, and NIOSH. The criteria for listing chemicals through the "authoritative bodies" mechanism are set forth in Title 22, California Code of Regulations (22 CCR) Section 12306.

The second mechanism for the administrative listing of a chemical applies if a state or federal agency has formally required that the chemical be labeled or identified as causing cancer or reproductive toxicity. The criteria for listing chemicals through this mechanism are set forth in 22 CCR Section 12902.

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is investigating the possible listing of the chemicals identified below, based upon information in the references cited. Documentation summarizing the rationale for considering the evaluation of these chemicals for possible administrative listing is available from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the Internet at the link below.

OEHHA is committed to public participation and external scientific peer review in its implementation of Proposition 65, and welcomes public input on this listing process. As part of its efforts to ensure that regulatory decisions are based upon a thorough consideration of all relevant information, OEHHA is soliciting information which may be relevant to the evaluation of these chemicals in the context of the Proposition 65 administrative listing regulatory criteria (22 CCR Section 12306 or Section 12902, as appropriate).

A public forum will be held on January 11, 1999 to provide an opportunity for interested parties to present oral comments and to discuss the scientific data and other information relevant to a determination as to whether these chemicals meet the criteria for listing set forth in 22 CCR Section 12306 or Section 12902. The public forum will be conducted at 10:00 a.m. in the Auditorium at 714 P Street, Sacramento, California, and will last until all business has been conducted or until 5:00 p.m.

Written comments provided in triplicate, along with supporting information, may also be submitted to:

Cynthia Oshita
Office of Environmental Health Hazard Assessment
1001 I Street,
Sacramento, CA 95814

FAX: (916) 327-1097
Telephone: (916) 445-6900

In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered or sent by fax) by 5:00 p.m. February 2, 1999.

Following the review of all comments received, OEHHA will announce its intention to proceed with the listing of those candidate chemicals that meet the regulatory criteria for administrative listing in a Notice of Intent to List Chemicals.

Download the documentation summarizing the rationale for considering the evaluation of these chemicals for possible administrative listing as an Adobe Acrobat PDF file.  You will need the free program Adobe Acrobat Reader to view or print this file.

A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as known to cause carcinogenicity via the "authoritative bodies" mechanism:

B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as known to cause reproductive toxicity via the "authoritative bodies" mechanism:

C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as known to cause reproductive toxicity via the "formally required to be labeled or identified" mechanism:

Chemical	CAS No.	Toxicological Endpoints	References
Acetazolamide	59-66-5	developmental toxicity	FDA (1990a)
Altretamine	645-05-6	developmental toxicity male reproductive toxicity	FDA (1993a)
Etodolac	41340-25-4	developmental toxicity female reproductive toxicity	FDA (1996)
Flurbiprofen	5104-49-4	developmental toxicity female reproductive toxicity	FDA (1989a)
Gemfibrozil	25812-30-0	male reproductive toxicity female reproductive toxicity	FDA (1995a)
Halobetasol propionate	66852-54-8	developmental toxicity	FDA (1990b)
Idarubicin hydrochloride	---	developmental toxicity male reproductive toxicity	FDA (1995b)
Mebendazole	31431-39-7	developmental toxicity	FDA (1989b)
Pimozide	2062-78-4	developmental toxicity female reproductive toxicity	FDA (1994)
Prednisolone sodium phosphate	125-02-0	developmental toxicity	FDA (1993b)
Sermorelin acetate	---	developmental toxicity	FDA (1991)
Streptozocin	18883-66-4	developmental toxicity male reproductive toxicity female reproductive toxicity	FDA (1986)

References:
Food and Drug Administration (FDA, 1986). Final printed labeling for the drug streptozocin sterile powder. FDA approved 1986.

Food and Drug Administration (FDA, 1989a). Final printed labeling for the drug flurbiprofen. FDA approved 1989.

Food and Drug Administration (FDA, 1989b). Final printed labeling for the drug mebendazole. FDA approved 1989.

Food and Drug Administration (FDA, 1990a). Final printed labeling for the drug acetazolamide. FDA approved 1990.

Food and Drug Administration (FDA, 1990b). Final printed labeling for the drug halobetasol propionate. FDA approved 1990.

Food and Drug Administration (FDA, 1991). Final printed labeling for the drug sermorelin acetate. FDA approved 1991.

Food and Drug Administration (FDA, 1993a). Final printed labeling for the drug altretamine. FDA approved 1993.

Food and Drug Administration (FDA, 1993b). Final printed labeling for the drug prednisolone sodium phosphate. FDA approved 1993.

Food and Drug Administration (FDA, 1994). Final printed labeling for the drug pimozide. FDA approved 1994.

Food and Drug Administration (FDA, 1995a). Final printed labeling for the drug gemfibrozil. FDA approved 1995.

Food and Drug Administration (FDA, 1995b). Final printed labeling for the drug idarubicin hydrochloride. FDA approved 1995.

Food and Drug Administration (FDA, 1996). Final printed labeling for the drug etodolac. FDA approved 1996.

National Institute for Occupational Safety and Health (NIOSH, 1984). Current Intelligence Bulletin 43: Monohalomethanes (Methyl Chloride CH3Cl, Methyl Bromide CH3Br, Methyl Iodide CH3I). US Department of Health and Human Services, Public Health Services, NIOSH.

National Institute for Occupational Safety and Health (NIOSH, 1985). Current Intelligence Bulletin 44. Dinitrotoluenes (DNT). US Department of Health and Human Services. Public Health Service. Centers for Disease Control. NIOSH.

National Institute for Occupational Safety and Health (NIOSH, 1990) NIOH and NIOSH Basis for an Occupational Health Standard: DI (2-ethylhexyl)phthalate (DEHP). US Department of Health and Human Services. Public Health Service. Centers for Disease Control. NIOSH.

National Institute for Occupational Safety and Health (NIOSH, 1994) NIOSH Pocket Guide to Chemical Hazards. US Department of Health and Human Services. Public Health Service. Centers for Disease Control. NIOSH.

National Toxicology Program (NTP, 1996a). Toxicology and Carcinogenesis Studies of Chloroprene (CAS No. 126-99-8) in F344/N Rats and B6C3F₁ Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 467 NTIS Publication No. 96-3957. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Cobalt Sulfate Heptahydrate (CAS No. 10026-24-1) in F344/N Rats and B6C3F₁ Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 471 NTIS Publication No. 96-3961. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996c). Toxicology and Carcinogenesis Studies of Primidone (CAS No. 125-33-7) in F344/N Rats and B6C3F₁ Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 476 NTIS Publication No. 96-3966. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996d). Summary Minutes from Peer Review of Draft Technical Reports of Long-Term Toxicology and Carcinogenesis Studies by the Technical Reports Review Subcommittee on December 11-12, 1996. NTP, Research Triangle Park, NC.

US Environmental Protection Agency (US EPA, 1980). Ambient Water Quality Criteria for Heptachlor. Office of Water Regulations and Standards; Criteria and Standards Division. Washington, D.C.

US Environmental Protection Agency (US EPA, 1986a). Health and Environmental Effects Profile for Dinitrotoluene. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Office of Research and Development, US EPA, Cincinnati, OH.

US Environmental Protection Agency (US EPA, 1986b). Guidance for the Reregistration of Pesticide Products Containing as the Active Ingredient Heptachlor. US EPA, OPP, Washington DC.

US Environmental Protection Agency (US EPA, 1994). Memorandum: Carcinogenicity Peer Review of Orthophenylphenol (OPP) and Sodium Orthophenylphenol (SOPP). Office of Prevention, Pesticides and Toxic Substances. August 24, 1994.

US Environmental Protection Agency (US EPA, 1996a). Memorandum: Carcinogenicity Review Committee Review on Fenoxycarb. Office of Prevention, Pesticides and Toxic Substances. April 1, 1996.

US Environmental Protection Agency (US EPA, 1996b). Memorandum: Carcinogenicity Peer Review of Morestan (Oxythioquinox). Office of Prevention, Pesticides and Toxic Substances. February 15, 1996.

US Environmental Protection Agency (US EPA, 1996c). Memorandum: Carcinogenicity Peer Review of Thiodicarb. Office of Prevention, Pesticides and Toxic Substances. June, 10, 1996.

US Environmental Protection Agency (US EPA, 1996d). Memorandum: Carcinogenicity Peer Review of Vinclozolin (2^nd). Office of Prevention, Pesticides and Toxic Substances. September 18, 1966.

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For questions regarding Proposition 65, please contact the Cynthia Oshita in the Proposition 65 Implementation Program

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