Notice of Intent to List: Fumonisin B1

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 a body considered to be authoritative by the state's qualified experts has formally identified it as causing cancer or reproductive toxicity. The following are identified as authoritative bodies for purposes of Proposition 65 as it pertains to chemicals known to cause cancer: the U.S. Environmental Protection Agency, the International Agency for Research on Cancer, the U.S. Food and Drug Administration, the National Institute for Occupational Safety and Health, and the National Toxicology Program. The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations (22 CCR), Section 12306.

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 fumonisin B1 as known to the State to cause cancer, pursuant to this administrative mechanism as provided in Health and Safety Code Section 25249.8(b) and 22 CCR, Section 12306.

Relevant information on fumonisin B1 (CAS No. 116355-83-0) was requested in a notice published in the California Regulatory Notice Register on June 2, 2000 (Register 00, No. 22-Z). A public forum was held on July 11, 2000. OEHHA has determined that fumonisin B1 meets the criteria for listing under 22 CCR, Section 12306, and therefore is issuing a notice of intent to list fumonisin B1 under Proposition 65. A document providing more detail on the basis for the listing of this chemical can be obtained from OEHHA's Proposition 65 Implementation Office at the address and telephone number indicated below, or from the downloads section below. Anyone objecting to the listing of fumonisin B1 as causing cancer on the basis that there is no substantial evidence that the criteria for sufficiency of evidence as causing cancer specified in 22 CCR, Section 12306 have been satisfied 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
Street Address: 1001 I Street
Sacramento, California 95814
Mailing Address: P.O. Box 4010
Sacramento, California 95812-4010
Fax No.: (916) 323-8803 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 postmarked (if sent by mail) or received at OEHHA (if delivered in person or sent by FAX) by 5:00 p.m. on Monday, September 8, 2003

The following chemical has been 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. Toxicological
Endpoint
Reference
Fumonisin B1 116355-83-0 Cancer NTP (2001)
IARC (2002)

Footnotes and References

References

International Agency for Research on Cancer (IARC, 2002). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 82: 301-366. Some Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene. IARC, Lyon France.

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. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.