Notice of Intent to List 21 Chemicals

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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. For carcinogenicity, the United States Environmental Protection Agency (U.S. EPA), 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) have been identified as authoritative bodies for purposes of the Act. For reproductive toxicity, U.S. EPA, IARC (for transplacental carcinogenicity only), FDA, and NIOSH have been identified as authoritative bodies for purposes of the Act. The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations (22 CCR), Section 12306.

Under the second mechanism for the administrative listing, a chemical is listed when 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 public notice published on December 4, 1998, OEHHA announced 26 chemicals were under consideration for administrative 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. The public comment period began on December 4, 1998, and closed on February 2, 1999. A public forum was held on January 11, 1999 to provide an opportunity for oral comments. No comments were received on 21 of the chemicals during the public comment period. OEHHA has determined that these 21 chemicals meet the criteria for administrative listing: nine chemicals meet the criteria for listing under the authoritative bodies mechanism (Tables A1 and A2), and 12 chemicals meet the criteria for listing via the ‘formally required to be labeled’ mechanism (Table B). Documents providing the basis for the listing of these chemicals can be obtained from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the download section below. OEHHA is currently reviewing the comments submitted on the remaining five chemicals.

Under the authoritative bodies mechanism, objections to the listing shall be made 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. Objections to listings via the second mechanism are made on the basis that the criteria and definitions in 22 CCR, Section 12902 have not been met. Any one wishing to object to the listing of chemicals in the tables below should submit written comments in triplicate, along with supporting documentation, by mail or by fax to:

Office of Environmental Health Hazard Assessment
301 Capitol Mall, 2nd Floor, Room 205
Sacramento, California 95814
Fax No.: (916) 327-1097
Telephone: (916) 445-6900

Comments may also be hand-delivered to 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 p.m. on Monday, April 19, 1999.

Table A1. Chemicals determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing cancer under the authoritative bodies mechanism:

Chemical

CAS No.

Reference

Oxythioquinox

2439-01-2

U.S. EPA (1996a)

Primidone

125-33-7

NTP(1996a, 1996b)

Thiodicarb

59669-26-0

U.S. EPA (1996b)

Vinclozolin

50471-44-8

U.S. EPA (1996c)

Table A2. 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:

Chemical

CAS No.

Toxicological Endpoints

Reference

2,4-Dinitrotoluene

121-14-2

male reproductive toxicity

U.S. EPA (1986a)

2,6-Dinitrotoluene

606-20-2

male reproductive toxicity

NIOSH (1985)
U.S. EPA (1986a)

Technical Grade Dinitrotoluene

---

female reproductive toxicity
male reproductive toxicity

NIOSH (1985)

Heptachlor

76-44-8

developmental toxicity

U.S. EPA (1980, 1986b)

Methyl chloride

74-87-3

developmental toxicity
male reproductive toxicity

NIOSH (1984, 1994)

Table B. Chemicals which 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)

Footnotes and References

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). U.S. 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). U.S. 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. U.S. Department of Health and Human Services. Public Health Service. Centers for Disease Control. NIOSH.

National Toxicology Program (NTP, 1996a). 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. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1996b). 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.

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

U.S. Environmental Protection Agency (U.S. 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, U.S. EPA, Cincinnati, OH.

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

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

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

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