Postpone Prioritization of Chemicals for Possible Consideration by the Developmental And Reproductive Toxicant Identification Committee
The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
In public notices which were published on October 4, 1996 in this register, OEHHA (1) gave notice of a public forum on November 15, 1996, to receive comments on the draft data summaries and levels of toxicological concern for candidate chemicals to be prioritized for possible consideration by the Developmental and Reproductive Toxicant (DART) Identification Committee, and (2) gave notice of a meeting of the DART Identification Committee on December 4, 1996, at which the Committee would discuss the same list of draft prioritized candidate chemicals. Included on the list of draft prioritized candidate chemicals were carbamazepine and progesterone.
In order to fully explore the potential candidacy of these chemicals for listing under administrative mechanisms, OEHHA has decided to postpone action on carbamazepine and progesterone for prioritization for possible consideration by the DART Identification Committee. To this end, OEHHA will request clarification from the U.S. Food and Drug Administration (FDA) concerning (1) the intent of their required label with regard to communicating a risk of developmental or reproductive harm, and (2) their findings and conclusions pertaining to the developmental and reproductive toxicity of these two drugs. Following receipt of relevant information from the U.S. FDA, OEHHA will determine the appropriate course of action at that time.
Because of this postponement in consideration of carbamazepine and progesterone , OEHHA will not be soliciting comment relative to either of these two chemicals at the November 15, 1996 public forum, nor will these chemicals be brought before the DART Committee for consideration at their December 4, 1996 meeting.
Any further action taken on either carbamazepine or progesterone will be published in a future notice.
Questions or comments concerning this notice should be directed to:
Proposition 65 Office
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-2265
Street Address: 1001 I Street
Sacramento, California 95814
- Progesterone
- Carbamazepine