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The Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65), codified at Health and Safety Code section 25249.5 et seq., provides two primary mechanisms for administratively listing chemicals that are known to the State to cause cancer or reproductive toxicity (Health and Safety Code section 25249.8(b)). A chemical may be listed under Proposition 65 when a body considered to be authoritative by the state’s qualified experts has formally identified the chemical as causing cancer or reproductive toxicity. The following entities are identified as authoritative bodies for purposes of Proposition 65, as it pertains to chemicals known to cause reproductive toxicity: the U.S. Environmental Protection Agency, the International Agency for Research on Cancer solely as to transplacental carcinogenicity, the U.S. Food and Drug Administration, the National Institute for Occupational Safety and Health, and the National Toxicology Program (NTP) solely as to final reports of the NTP’s Center for Evaluation of Risks to Human Reproduction. The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations, section 12306.

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA), within the California Environmental Protection Agency intends to list the chemicals identified in the table below as known to the State to cause reproductive toxicity, pursuant to this administrative mechanism as provided in Health and Safety Code section 25249.8(b) and Title 22, Cal. Code of Regs., section 12306.

Relevant information related to the possible listing of butyl benzyl phthalate, di-n-butyl phthalate, di-n-hexyl phthalate, and di-isodecyl phthalate was requested in a notice published in the California Regulatory Notice Register on May 28, 2004 (Register 04, No. 22-Z). The opportunity to request a public forum was provided, but no such request was received and no forum was held. A request for an extension of the public comment period was made and granted for the four named phthalates. The extended comment period closed on August 26, 2004. Comments were received and reviewed by OEHHA staff in consideration of the listing of the four phthalates. OEHHA has determined that butyl benzyl phthalate, di-n-butyl phthalate, di-n-hexyl phthalate, and di-isodecyl phthalate, meet the criteria for listing under Title 22, Cal. Code of Regs., section 12306, and therefore OEHHA is issuing this notice of intent to list these chemicals under Proposition 65. A document providing more detail on 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 OEHHA Web site at: http://www.oehha.ca.gov/. Anyone wishing to provide comments as to whether the listing of these chemicals meets the criteria for listing provided in Title 22, Cal. Code of Regs., section 12306 should send written comments in triplicate, along with any 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 delivered in person or by courier to the above address. It is requested, but not required, that written comments and supporting documentation be transmitted via email addressed to: coshita@oehha.ca.gov. In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered, sent by FAX, or transmitted electronically) by 5:00 p.m. on Monday, April 4, 2005.

The following chemical has been determined by OEHHA to meet the criteria set forth in Title 22, Cal. Code of Regs., section 12306 for listing as causing reproductive toxicity under the authoritative bodies mechanism:

¹DIDP is a complex substance, assigned two different CAS Numbers. See NTP-CEHR (2003d) for details.

REFERENCE

National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003a). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP). NIH Publication No. 03-4487.

National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003b). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). NIH Publication No. 03-4486.

National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003c). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Hexyl Phthalate (DnHP). NIH Publication No. 03-4489.

National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003d). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-Isodecyl Phthalate (DIDP). NIH Publication No. 03-4485.

Follow this link to download a copy of this notice

Follow this link to download a copy of the document providing more detail on the basis for the listing of these chemicals

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

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