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Chemicals Under Consideration for Possible Listing Via the Authoritative Bodies Mechanisms: Request For Relevant Information on 2-Bromopropane

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act) which is codified at Health and Safety Code section 25249.5 et seq., requires the Governor to publish, and update at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity. The Act provides two primary mechanisms for administratively listing chemicals as 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 reproductive toxicity, the U.S. Environmental Protection Agency, the International Agency for Research on Cancer solely as to transplacental carcinogenicity, the National Toxicology Program (NTP) solely as to final reports of the NTP’s Center for Evaluation of Risks to Human Reproduction (NTP-CERHR), the U.S. Food and Drug Administration, and the National Institute for Occupational Safety and Health 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, 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 is investigating the possible listing of 2-bromopropane as a chemical known to cause reproductive toxicity (female and male endpoints), based upon information in the reference cited. Documentation summarizing the rationale for considering the evaluation of this chemical for possible administrative listing is available from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the downloads section below.

OEHHA is committed to public participation and external scientific peer review in its implementation of Proposition 65, and welcomes public input on this listing process. As part of its efforts to ensure that regulatory decisions are based upon a thorough consideration of all relevant information, OEHHA is soliciting information concerning whether the criteria set out in Section 12306 have been met for this chemical.

A public forum to present oral comments and to discuss the scientific data and other information concerning whether this chemical meets the criteria for listing set forth in Section 12306 will be scheduled only upon request. Such request must be submitted in writing no later than 30 days before the close of the comment period on Tuesday, March 8, 2005. The written request must be sent to OEHHA at the address listed below no later than Friday, February 4, 2005. A notice for the public forum, if one is requested, will be posted on the OEHHA web site at least ten days in advance of the forum date. The notice will provide the date, time, location and subject matter to be heard. Notices will also be sent to those individuals requesting such notification. Written comments provided in triplicate, along with supporting information, should be submitted 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 Tuesday, March 8, 2005.

Following the review of all comments received, OEHHA will announce its intention to proceed with the listing of this candidate chemical that meets the regulatory criteria for administrative listing in a Notice of Intent to List Chemicals.

A. A chemical which may meet the criteria set forth in Section 12306 for listing as known to cause reproductive toxicity via the “authoritative bodies” mechanism:

Chemical CAS No. Toxicological Endpoints Chemical Use Ref.
2-Bromopropane 75263 Male reproductive toxicity
Female reproductive toxicity		 Intermediate in the synthesis of pharma-ceuticals, dyes, and other organic chemicals; contaminant of 1-bromopropane NTP-CERHR (2003)

Downloads

Footnotes and References

REFERENCE

National Toxicology Program - Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR, 2003). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of 2-Bromopropane . NIH Publication No. 04-4480. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NTP, Research Triangle Park, NC.