Workshop on the Authoritative Bodies Mechanism for Listing Under Proposition 65

The Office of Environmental Health Hazard Assessment (OEHHA) is conducting a workshop to discuss issues related to the implementation of the authoritative bodies mechanism for listing under Proposition 65. The workshop will be held from 9:00 am to 5:30 PM on June 11, 1998 at the University of California, Berkeley, campus in the International House auditorium. The auditorium is located at 2299 Piedmont Avenue (at the terminus of Bancroft Way) in the city of Berkeley.

The Proposition 65 statute requires the state to publish, and update at least annually, a list of chemicals known to cause cancer or reproductive toxicity. One of the mechanisms identified in the Proposition 65 statute is the listing of chemicals formally identified as causing cancer or reproductive toxicity by a body considered to be authoritative under Proposition 65 by the State’s qualified experts (i.e., the Carcinogen Identification Committee (CIC) and Developmental and Reproductive Toxicant Identification Committee (DART) of the OEHHA Science Advisory Board). The regulatory guidance for listing by this mechanism is set forth in Title 22, California Code of Regulations (CCR), Section 12306. The authoritative bodies currently identified are the US Environmental Protection Agency, International Agency for Research on Cancer, National Institute of Occupational Safety and Health, US Food and Drug Administration, and National Toxicology Program.

At their meeting of December 9, 1997, the DART requested that OEHHA convene a public workshop to discuss issues pertaining to the authoritative bodies mechanism for listing chemicals under Proposition 65. Specific issues raised by the DART included those noted for consideration by the Core Committee of the Risk Assessment Advisory Committee (RAAC): general criteria for authoritative bodies designations, ascertaining the nature and use of peer review in conferring designations, possible designations for limited time periods, greater definition of specific activities within a large organization which would be covered under an authoritative body designation. Other topics identified by the DART for discussion at the workshop were the expertise of existing authoritative bodies in identifying agents as causing reproductive toxicity, and procedures for reconciling cases where authoritative bodies disagree about the potential of an agent to cause reproductive toxicity (or cancer) ('dueling authoritative bodies'). The latter topic had also been previously raised by OEHHA as an issue for discussion at a public workshop (e.g., at the September 25, 1997, CIC meeting).

On January 23, 1998, OEHHA published a notice in the California Regulatory Notice Register and on the OEHHA Web site soliciting public participation and input in the planning of the workshop. Specific recommendations for possible topics for discussion at the workshop were requested and information received was taken into account in the preparation of the agenda for the workshop.

The workshop agenda will include the following topics:

• Legal aspects of implementation of the authoritative bodies listing mechanism
• Scientific aspects of implementation of the authoritative bodies listing mechanism
• Background on existing authoritative bodies
• Issues identified in the Report of the Risk Assessment Advisory Committee
• The possible need to update the scientific criteria for "as causing cancer" in 22 CCR 12306
• The possible need to update the scientific criteria for "as causing reproductive toxicity" in 22 CCR 12306
• Additional bodies suggested by the public for designation as "authoritative"

It is anticipated that several members of the CIC and DART will attend the workshop.