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 such mechanism by which a chemical may be listed is if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity. The criteria for listing chemicals through the formally required to be labeled or identified mechanism are set forth in Title 22, California Code of Regulations (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 this administrative mechanism as provided in Health and Safety Code Section 25249.8(b) and 22 CCR, Section 12902.

In a notice dated September 4, 1998, OEHHA announced chemicals under consideration for listing based on a review of information indicating that the chemicals may meet the criteria set forth in 22 CCR, 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. The public comment period began on September 4, 1998, and closed on November 3, 1998. A public forum was held on October 15, 1998 to provide an opportunity for oral comments. No comments were received during the public comment period.

OEHHA has determined that the criteria for listing under 22 CCR, Section 12902 have been met and is issuing this notice of intent to list on the chemicals provided in the table below. A document providing the basis for the listing can be obtained from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the OEHHA Home Page at: http://www.oehha.org/prop65/CRNR_notices/admin_listing/
requests_info/referenced_docs/frpkg12f.html. Anyone wishing to comment on the listing of the chemicals identified below as causing cancer or reproductive toxicity on the basis that the listing does not satisfy the definitions set forth in 22 CCR, Section 12902(b) 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
Telephone: (916) 445-6900

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 received at OEHHA by 5:00 PM on Monday, December 28, 1998.

The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12902 for listing as causing cancer under the formally required to be labeled or identified mechanism:

Chemical	CAS No.	Reference
Cidofovir	113852-37-2	FDA (1996a)

The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12902 for listing as causing reproductive toxicity under the formally required to be labeled or identified mechanism:

Chemical	CAS No.	Reproductive toxicity endpoint	Reference
Auranofin	34031-32-8	Developmental toxicity	FDA (1989a)
Carbamazepine	298-46-4	Developmental toxicity	FDA (1998)
Cidofovir	113852-37-2	Developmental toxicity Female reproductive toxicity Male reproductive toxicity	FDA (1996a)
Dacarbazine	4342-03-4	Developmental toxicity	FDA (1989b)
Diflunisal	22494-42-4	Developmental toxicity Female reproductive toxicity	FDA (1994a)
Doxorubicin hydrochloride	23214-92-8	Developmental toxicity Male reproductive toxicity	FDA (1994b)
Haloperidol	52-86-8	Developmental toxicity Female reproductive toxicity	FDA (1988a)
Levodopa	59-92-7	Developmental toxicity	FDA (1986)
Nifedipine	21829-25-4	Developmental toxicity Female reproductive toxicity Male reproductive toxicity	FDA (1996b)
Pyrimethamine	58-14-0	Developmental toxicity	FDA (1988b)
Sulfasalazine	599-79-1	Male reproductive toxicity	FDA (1996)
Sulindac	38194-50-2	Developmental toxicity Female reproductive toxicity	FDA (1995)

References
Food and Drug Administration (FDA, 1986). Final printed labeling for the drug levodopa. FDA approved 1986.

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

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

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

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

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

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

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

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

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

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

Food and Drug Administration (FDA, 1998). Final printed labeling for the drug carbamezepine. FDA approved 1998.

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

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