Workshop on Proposition 65 listings via the Authoritative Bodies Mechanism
This workshop is being conducted by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) to discuss issues related to the implementation of the authoritative bodies mechanism for listing under Proposition 65. The agenda was developed, in part, from comments received from interested parties. Agenda items are for discussion; some changes to the process or regulation may not be advisable or legally permissible.
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 and Developmental and Reproductive Toxicant Identification Committee 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.
Workshop Chair: Val Siebal, Chief Deputy Director, OEHHA
9:00 Welcome
- Joan E. Denton, Director, OEHHA
- Goals and objectives of the workshop
- Val Siebal, Chief Deputy Director, OEHHA
9:15 Legal aspects of authoritative bodies implementation
- Ed Weil, Deputy Attorney General (20 min.)
- Proposition 65 statutory requirements and overview of 22 CCR 12306
- Criteria for formal identification
- Legal requirements when authoritative bodies’ findings differ
- Toxic Release Inventory litigation
- Public discussion and comment
10:15 BREAK
10:30 Designating authoritative bodies
- Lauren Zeise, Chief, OEHHA Reproductive and Cancer Hazard Assessment Section (RCHAS) (15 min.)
- Public discussion and comment on issues, for example
- Whether there is a need to establish general criteria for authoritative body designations
- To what extent does expert peer review function in the decision to confer authoritative body designations
- Whether designations should be re-reviewed and, if so, under what circumstances
11:30 Existing authoritative bodies
- Martha Sandy, Chief, OEHHA RCHAS Cancer Unit (20 min.)
- Public discussion and comment on issues, for example
- Authoritative bodies’ expertise and processes utilized in their determinations
- Application of 12306 guidance
- The possible need for greater definition of specific activities as authoritative within a large organization, such as US EPA
- US EPA’s Toxic Release Inventory
12:30 LUNCH
1:30 Continuation of discussion on existing authoritative bodies
3:30 BREAK
3:45 Other bodies suggested by the public for designation as "authoritative"
- Marlissa Campbell, OEHHA RCHAS Reproductive Toxicology Unit (5 min.)
- Suggestions from the public:
- Agency for Toxic Substances and Disease Registry
- International Programme on Chemical Safety
- Health Environment Canada
- Discussion and public comment on issues, such as the nature of potential conflicts among existing and potential authoritative bodies
- Next steps concerning designation of authoritative bodies
4:15 Scientific criteria for "as causing "in 22 CCR 12306
- Jim Donald, Chief, OEHHA RCHAS Reproductive Toxicology Unit (10 min.)
- Discussion and public comment
5:15 Public comment on additional issues related to the authoritative bodies listing mechanism
5:30 Next Steps
ADJOURN