Proposition 65

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) provides two mechanisms for administratively listing chemicals which are 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. The following have been identified as authoritative bodies for purposes of the Act: the United States Environmental Protection Agency (USEPA), the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the United States Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (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 Act also provides another mechanism for the administrative listing of a chemical, that is 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 intends to list the chemicals identified below as known to the State to cause cancer or reproductive toxicity, pursuant to the two administrative mechanisms provided in Health and Safety Code Section 25249.8(b).

In a notice dated August 22, 1997, OEHHA announced that 46 chemicals were under consideration for listing based on a review of information indicating that the chemicals may meet the criteria set forth in 22 CCR, Section 12306 or Section 12902. OEHHA solicited comments and information relevant to the evaluation of these chemicals in the context of the regulatory criteria for administrative listing under Proposition 65. On September 12, 1997, OEHHA published another notice soliciting comments and information concerning the possible administrative listing of phenolphthalein. The public comment period began on August 22, 1997, and was extended to close on November 5, 1997 for all the chemicals except phenolphthalein whose comment period began on September 12, 1997 and closed on November 12, 1997. A public forum was held for all 47 chemicals on October 1, 1997 to provide an opportunity for oral comments. Many comments were received during the public comment period; however only on a relatively small number of chemicals. To date, OEHHA has completed its review of comments received on 31 of the chemicals, the remaining 16 chemicals are still under review to determine if the regulatory criteria for administrative listing have been met. In the interest of moving forward on those chemicals that OEHHA has determined meet the criteria for listing under 22 CCR, Section 12306 or Section 12902, the following sub-list of 31 chemicals is provided. Anyone objecting to the listing of the chemicals identified under Section A below as causing cancer or causing reproductive toxicity on the basis that there is no substantial evidence that the criteria of sufficiency of evidence of carcinogenicity or reproductive toxicity identified in 22 CCR, Section 12306 have been satisfied, or to the listing of the chemicals identified in Section B below as causing reproductive toxicity on the basis that the criteria in 22 CCR, Section 12902 have not been met, should provide written comments in triplicate, along with supporting documentation, by mail or by fax to:

Ms. Cynthia Oshita
Office of Environmental Health Hazard Assessment
Post Office Box 4010
Sacramento, CA 95812-4010
Fax No.: (916) 327-1097

Comments may also be hand-delivered to Ms. Oshita at the Office of Environmental Health Hazard Assessment at the same address.

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 PM on January 21, 1998.

A. Chemicals determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing reproductive toxicity under the authoritative bodies mechanism:

Endrin	72-20-8	developmental toxicity		US EPA (1980, 1992b)
Ethylene dibromide	106-93-4	developmental toxicity male reproductive toxicity		NIOSH (1977) US EPA (1987a, b)
Metham Sodium	137-42-8	developmental toxicity	US EPA (1994a, b)
Oxadiazon	19666-30-9	developmental toxicity		US EPA (1994a, b)
Vinclozolin	50471-44-8	developmental toxicity		US EPA (1994a, b, 1988b)
Zearalenone	17924-92-4	male reproductive toxicity		NTP (1982b)
		female reproductive toxicity		IARC (1993)

B. The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12902 for listing based on a formal requirement for labeling or identification as causing reproductive toxicity:

Chemical	CAS No.	Toxicological Endpoints	References
Amoxapine	14028-44-5	developmental toxicity	FDA (1988a)
Beclomethasone dipropionate	5534-09-8	developmental toxicity	FDA (1988b)
Clobetasol propionate	25122-46-7	developmental toxicity female reproductive toxicity	FDA (1995a)
Codeine phosphate	52-28-8	developmental toxicity	FDA (1989)
Flunisolide	3385-03-3	developmental toxicity female reproductive toxicity	FDA (1984)
Fluticasone propionate	80474-14-2	developmental toxicity	FDA (1995b)
Histrelin acetate	---	developmental toxicity	FDA (1991)
Levonorgestrel implants	797-63-7	female reproductive toxicity	FDA (1995c)

References
California Department of Food and Agriculture (CDFA, 1987) Summary of Toxicology Data: Oxadiazon. Medical Toxicology Branch. Last updated, 4/11/90.

California Department of Food and Agriculture (CDFA, 1986) Summary of Toxicology Data: Metam-Sodium. Medical Toxicology Branch. Last updated, 6/15/92.

Food and Drug Administration (FDA, 1988a). Final printed labeling for the drug amoxapine. FDA approved 1988.

Food and Drug Administration (FDA, 1988b). Final printed labeling for the drug beclomethasone dipropionate. FDA approved 1988.

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

Food and Drug Administration (FDA, 1989). Final printed labeling for the drug codeine phosphate. FDA approved 1993.

Food and Drug Administration (FDA, 1984). Final printed labeling for the drug flunisolide. FDA approved 1984.

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

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

Food and Drug Administration (FDA, 1995c). Final printed labeling for the drug levonorgestrel implants. FDA approved 1995.

Food and Drug Administration (FDA, 1997). Minutes from the Carcinogenicity Assessment Committee (CAC) Meeting, April 30, 1997, US Department of Health and Human Services, Public Health Service, Food and Drug Administration.

International Agency for Research on Cancer (IARC, 1993). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 56:397-444. Some Naturally Occurring Substances: Food Items and Constituents, Heterocyclic Aromatic Amines and Mycotoxins. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1991). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 53: 179-249. Occupational Exposures in Insecticide Application, and Some Pesticides. DDT and Associated Compounds. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1990). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 48: 123-137. Some Flame Retardants and Textile Chemicals, and Exposures in the Textile Manufacturing Industry. IARC, Lyon, France.

International Agency for Research on Cancer (1983). IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Volume 32. Polynuclear Aromatic Compounds, Part 1, Chemical, Environmental and Experimental Data. IARC, Lyon, France.

National Institute for Occupational Safety and Health (NIOSH, 1988). Occupational Safety and Health Guideline for DDT. US Department of Health and Human Services, NIOSH.

National Institute for Occupational Safety and Health (NIOSH, 1977). Criteria for a recommended standard . . . Occupational Exposure to Ethylene Dibromide. DHEW (NIOSH) Publication No. 77-221. US Department of Health and Human Services, NIOSH.

National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F₁Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F₁ Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F₁Mice (Gavage Studies). NTP Technical Report Series No. 351. NTIS Publication No. 89-2806. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F₁Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F₁Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1982a). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F₁Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1982b). Carcinogenesis Bioassay of Zearalenone in F344/N Rats and B6C3F₁ Mice. NTP Technical Report Series No. 235. NTIS Publication No. 83-1791. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

Office of Environmental Health Hazard Assessment (OEHHA, 1992) Evaluation of Health Risks Associated with the Metam Spill in the Upper Sacramento River. (External Review Draft). California Environmental Protection Agency, OEHHA, Sacramento, CA.

US Environmental Protection Agency (US EPA, 1995a). Memorandum: Carcinogenicity Peer Review of Metam Sodium. Office of Prevention, Pesticides and Toxic Substances. May 1, 1995.

US Environmental Protection Agency (US EPA, 1995c). Health Test Guidelines. OPPRS 870.3700; Prenatal Developmental Toxicity Study. Public Draft.

US Environmental Protection Agency (US EPA, 1994a) Proposed Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59 FR 1788).

US Environmental Protection Agency (US EPA, 1994b) Final Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59(229) FR 61432).

US Environmental Protection Agency (US EPA, 1994c) Office of Pesticides/HED/TB-1. Tox One-liners. Vinclozolin.

US Environmental Protection Agency (US EPA, 1993c). Support Document for the Addition of Chemicals from Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) Active Ingredients to EPCRA Section 313. USEPA/OPP.

US Environmental Protection Agency (US EPA, 1993d) Support Document for the Health and Ecological Toxicity Review of TRI Expansion Chemicals. Chemical Screening and Risk Assessment Division. OPPT.

US Environmental Protection Agency (US EPA, 1992b) Drinking Water Criteria Document for Endrin. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment.

US Environmental Protection Agency (US EPA, 1989b). Integrated Risk Information System (IRIS ): Aniline. CASRN 62-53-3. Environmental Criteria and Assessment Office, US EPA, Cincinnati, OH.

US Environmental Protection Agency (US EPA, 1988a). Updated Health Effects Assessment for DDT. 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, 1988b) Proposed Rule for Pesticide Tolerances for 3-(3,5-Dichlorophenyl)-5-Ethenyl-5-Methyl-2,4-Oxazolidinedione. Federal Register (53 FR 41209).

US Environmental Protection Agency (US EPA, 1987a). Health Effects Assessment for Ethylene Dibromide. 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, 1987b). Drinking Water Criteria Document for Ethylenedibromide (EDB). Office of Drinking Water, US EPA, Washington, D.C.

US Environmental Protection Agency (US EPA, 1985). Health and Environmental Effects Profile for Phenylenediamines. 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, 1983a) Health Effects Test Guidelines; Teratogenicity Study. Office of Toxic Substances, Office of Pesticides and Toxic Substances.

US Environmental Protection Agency (US EPA, 1983b) Health Effects Test Guidelines; Reproduction and Fertility Effects. Office of Toxic Substances, Office of Pesticides and Toxic Substances.

US Environmental Protection Agency (US EPA, 1980) Ambient Water Quality Criteria for Endrin. Office of Water Regulations and Standards Criteria and Standards Division.

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