Request for Information, Chemicals Under Consideration for Possible Listing Via Administrative Mechanisms: 20 Chemicals
The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) 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)]. 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. The following have been identified as authoritative bodies for purposes of the Act: the United States Environmental Protection Agency (EPA), the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the United States Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH). The criteria for listing chemicals through the "authoritative bodies" mechanism are set forth in Title 22, California Code of Regulations (22 CCR).
The second mechanism for the administrative listing of a chemical applies if 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 of chemicals through this 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. Documentation summarizing the rationale for considering the evaluation of these chemicals for possible administrative listing is available from OEHHA's Proposition 65 Implementation Office at the address and telephone number indicated below or by clicking on the links 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 administrative listing regulatory criteria (22 CCR Section 12306 or Section 12902, as appropriate).
A public forum will be held on Thursday, April 24, 1997 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 12306 or 12902. The public forum will be conducted at 10:00 a.m. in the Auditorium at 601 North 7th Street, Sacramento, California, and will last until all business has been conducted or until 5:00 p.m.
Written comments, along with supporting information, may also be submitted to:
The Proposition 65 Office
Office of Environmental Health Hazard Assessment
Mailing Address: Post Office Box 4010
Sacramento, CA 95812-4010
FAX: (916) 327-1097
Telephone: (916) 445-6900
In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered or sent by fax) by May 28, 1997.
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.
A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies"
| Chemical | CAS No. | Reference |
|---|---|---|
| 1-Amino-2,4-dibromoanthraquinone | 81-49-2 | NTP (1994a; 1994c) |
| C.I. Direct Blue 15 | 2429-74-5 | IARC (1993) |
| C.I. Direct Blue 218 | 28407-37-6 | NTP (1994b) |
| 3,7-Dinitrofluoranthene | 105735-71-5 | IARC (1996a) |
| 3,9-Dinitrofluoranthene | 22506-53-2 | IARC (1996a) |
| Nitrobenzene | 98-95-3 |
IARC (1996b) |
B. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as carcinogens via the "formally required "mechanism:
| Chemical | CAS No. | Reference |
|---|---|---|
| Estropipate | 7280-37-7 | FDA (1994) |
| Ganciclovir sodium | 82410-32-0 | FDA (1995a) |
| Premarin | 12126-59-9 | FDA (1995b) |
C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as developmental toxicants via the "formally required" mechanism:
| Chemical | CAS No. | Reference |
|---|---|---|
| Amiodarone hydrochloride | 19774-82-4 | FDA (1995c) |
| Atenolol | 29122-68-7 | FDA (1996a) |
| Estropipate | 7280-37-7 | FDA (1994) |
| Ethionamide | 536-33-4 | FDA (1969) |
| Ganciclovir sodium | 82410-32-0 | FDA (1995a) |
| Goserelin acetate | 65807-02-5 | FDA (1995d) |
| Leuprolide acetate | 74381-53-6 | FDA (1996b) |
| Paclitaxel | 33069-62-4 | FDA (1996c) |
| Premarin | 12126-59-9 | FDA (1995b) |
| Quazepam | 36735-22-5 | FDA (1991) |
| Trimetrexate glucuronate | 82952-64-5 | FDA (1993) |
- C.I. Direct Blue 218
- 1-Amino-2,4-dibromoanthraquinone
- 3,9-Dinitrofluoranthene
- C.I. Direct Blue 15
- 3,7-Dinitrofluoranthene
- Amiodarone Hydrochloride
- Atenolol
- Ethionamide
- Estropipate
- Goserelin Acetate
- Ganciclovir Sodium
- Leuprolide Acetate
- Quazepam
- Nitrobenzene
- Trimetrexate Glucuronate
- Paclitaxel
- Premarin
Chemical Reference
Footnotes and References
References
Food and Drug Administration (FDA, 1994). Final printed labeling for the drug estropipate. FDA approved June 1994.
Food and Drug Administration (FDA, 1995a). Final printed labeling for the drug ganciclovir sodium. FDA approved October 1995.
Food and Drug Administration (FDA, 1995b). Final printed labeling for the drug premarin. FDA approved September 1995.
Food and Drug Administration (FDA, 1995c). Final printed labeling for the drug amiodarone hydrochloride. FDA approved October 1995.
Food and Drug Administration (FDA, 1996a). Final printed labeling for the drug atenolol. FDA approved February 1996.
Food and Drug Administration (FDA, 1969). Final printed labeling for the drug ethionamide. FDA approved February 1969.
Food and Drug Administration (FDA, 1995d). Final printed labeling for the drug goserelin acetate. FDA approved December 1995.
Food and Drug Administration (FDA, 1996b). Final printed labeling for the drug leuprolide acetate. FDA approved April 1996.
Food and Drug Administration (FDA, 1996c). Final printed labeling for the drug paclitaxel. FDA approved April 1996.
Food and Drug Administration (FDA, 1991). Final printed labeling for the drug quazepam. FDA approved August 1991.
Food and Drug Administration (FDA, 1993). Final printed labeling for the drug trimetrexate glucuronate. FDA approved December 1993.
International Agency for Research on Cancer (IARC, 1993). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 57: 235-245. Occupational Exposures of Hairdressers and Barbers and Personal Use of Hair Colourants; Some Hair Dyes, Cosmetic Colourants, Industrial Dyestuffs and Aromatic Amines. IARC, Lyon, France.
International Agency for Research on Cancer (IARC, 1996a). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 65: 297-307. Printing Processes and Printing Inks, Carbon Black and Some Nitro Compounds. IARC, Lyon, France.
International Agency for Research on Cancer (IARC, 1996b). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 65: 381-408. Printing Processes and Printing Inks, Carbon Black and Some Nitro Compounds. IARC, Lyon, France.
National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1994a). Toxicology and Carcinogenesis Studies of 1-amino-2,4-dibromoanthraquinone (CAS No. 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 383. NTIS Publication No. 94-2838. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1994c). Summary Minutes from Peer Review of Draft Technical Reports of Long-Term Toxicology and Carcinogenesis Studies by the Technical Reports Review Subcommittee on June 21, 1994. NTP, Research Triangle Park, NC.