Request for Information, Chemicals Under Consideration for Possible Listing Via the "Formally Required to be Labeled or Identified" Mechanisms
The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act) 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 mechanisms for administratively listing chemicals as known to the State to cause cancer or reproductive toxicity [Health and Safety Code Section 25249.8(b)]. Under the first mechanism, a chemical is listed when a body considered to be authoritative by the state’s qualified experts has formally identified it as causing cancer or reproductive toxicity. The criteria for listing chemicals through this mechanism are set forth in Title 22, California Code of Regulations (22 CCR) Section 12306. Under the second mechanism, and the subject of today’s notice, listing occurs when a state or federal agency has formally required that the chemical be labeled or identified as causing cancer or reproductive toxicity. The criteria for listing chemicals through the "formally required to be labeled or identified" mechanism are set forth in 22 CCR Section 12902.
As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is investigating the possible listing of the chemicals identified below, based upon information in the references cited. All of the chemicals listed below are proposed for administrative listing based upon the US Food and Drug Administration having formally required the chemicals to be labeled or identified as causing cancer or developmental or reproductive toxicity. Documentation providing the basis for possible administrative listing of these chemicals is available from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the OEHHA web site in the download 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 which may be relevant to the evaluation of these chemicals in the context of the Proposition 65 "formally required to be labeled or identified"
A public forum will be held on Thursday, October 15, 1998 to provide an opportunity for interested parties to present oral comments and to discuss the scientific data and other information relevant to a determination as to whether these chemicals meet the criteria for listing set forth in 22 CCR Section 12902. The public forum will be held at 301 Capitol Mall, Third Floor Conference Room, Sacramento, California from 10:00 a.m. until all business has been conducted, or until 5:00 p.m.
Written comments provided in triplicate, along with supporting information, may also be submitted to:
Cynthia Oshita
Office of Environmental Health Hazard Assessment
301 Capitol Mall, 2nd Floor
Sacramento, CA 95814
FAX: (916) 327-1097
Telephone: (916) 445-6900
In order to be considered, comments must be received at OEHHA by 5:00 p.m., Tuesday, November 3, 1998.
Following the review of all comments received, OEHHA will announce its intention to proceed with the listing of those candidate chemicals that meet the regulatory criteria for administrative listing in a Notice of Intent to List Chemicals.
Chemicals which may meet the criteria (22 CCR Section 12902) for listing as known to cause cancer:
| Chemical | CAS No. | Reference |
|---|---|---|
| Cidofovir | 113852-37-2 | FDA (1996a) |
Chemicals which may meet the criteria (22 CCR Section 12902) for listing as known to cause reproductive toxicity:
| Chemical | CAS No. | Reproductive toxicity endpoint |
Reference |
|---|---|---|---|
| Auranofin | 34031-32-8 | Developmental toxicity | FDA (1989a) |
| Carbamazepine | 298-46-4 | Developmental toxicity | FDA (1998) |
| Cidofovir | 113852-37-2 | Developmental toxicity Female reproductive toxicity Male reproductive toxicity |
FDA (1996a) |
| Dacarbazine | 4342-03-4 | Developmental toxicity | FDA (1989b) |
| Diflunisal | 22494-42-4 | Developmental toxicity Female reproductive toxicity |
FDA (1994a) |
| Doxorubicin hydrochloride | 23214-92-8 | Developmental toxicity Male reproductive toxicity |
FDA (1994b) |
| Haloperidol | 52-86-8 | Developmental toxicity Female reproductive toxicity |
FDA (1988a) |
| Levodopa | 59-92-7 | Developmental toxicity | FDA (1986) |
| Nifedipine | 21829-25-4 | Developmental toxicity Female reproductive toxicity Male reproductive toxicity |
FDA (1996b) |
| Pyrimethamine | 58-14-0 | Developmental toxicity | FDA (1988b) |
| Sulfasalazine | 599-79-1 | Male reproductive toxicity | FDA (1996) |
| Sulindac | 38194-50-2 | Developmental toxicity Female reproductive toxicity |
FDA (1995) |
- Dacarbazine
- Carbamazepine
- Auranofin
- Doxorubicin Hydrochloride (Adriamycin)
- Cidofovir
- Haloperidol
- Diflunisal
- Levodopa
- Pyrimethamine
- Nifedipine
- Sulfasalazine (salicylazosulfapyridine)
- Sulindac
Chemical Reference
Footnotes and References
References
Food and Drug Administration (FDA, 1986). Final printed labeling for the drug levodopa. FDA approved 1986.
Food and Drug Administration (FDA, 1988a). Final printed labeling for the drug haloperidol. FDA approved 1988.
Food and Drug Administration (FDA, 1988b). Final printed labeling for the drug pyrimethamine. FDA approved 1988.
Food and Drug Administration (FDA, 1989a). Final printed labeling for the drug auranofin. FDA approved 1989.
Food and Drug Administration (FDA, 1989b). Final printed labeling for the drug dacarbazine. FDA approved 1989.
Food and Drug Administration (FDA, 1994a). Final printed labeling for the drug diflunisal. FDA approved 1994.
Food and Drug Administration (FDA, 1994b). Final printed labeling for the drug doxorubicin hydrochloride. FDA approved 1994
Food and Drug Administration (FDA, 1995). Final printed labeling for the drug sulindac. FDA approved 1995.
Food and Drug Administration (FDA, 1996a). Final printed labeling for the drug cidofovir. FDA approved 1996.
Food and Drug Administration (FDA, 1996b). Final printed labeling for the drug nifedipine. FDA approved 1996.
Food and Drug Administration (FDA, 1996c). Final printed labeling for the drug sulfasalazine. FDA approved 1996.
Food and Drug Administration (FDA, 1998). Final printed labeling for the drug carbamezepine. FDA approved 1998.