Notice of Intent to List 31 Chemicals
The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) provides two mechanisms for administratively listing chemicals which are 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 (USEPA), 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),Section 12306.
The Act also provides another mechanism for the administrative listing of a chemical, that is 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 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 intends to list the chemicals identified below as known to the State to cause cancer or reproductive toxicity, pursuant to the two administrative mechanisms provided in Health and Safety Code Section 25249.8(b).
In a notice dated August 22, 1997, OEHHA announced that 46 chemicals were under consideration for listing based on a review of information indicating that the chemicals may meet the criteria set forth in 22 CCR, Section 12306 or Section 12902. OEHHA solicited comments and information relevant to the evaluation of these chemicals in the context of the regulatory criteria for administrative listing under Proposition 65. On September 12, 1997, OEHHA published another notice soliciting comments and information concerning the possible administrative listing of phenolphthalein. The public comment period began on August 22, 1997, and was extended to close on November 5, 1997 for all the chemicals except phenolphthalein whose comment period began on September 12, 1997 and closed on November 12, 1997. A public forum was held for all 47 chemicals on October 1, 1997 to provide an opportunity for oral comments. Many comments were received during the public comment period; however only on a relatively small number of chemicals. To date, OEHHA has completed its review of comments received on 31 of the chemicals, the remaining 16 chemicals are still under review to determine if the regulatory criteria for administrative listing have been met. In the interest of moving forward on those chemicals that OEHHA has determined meet the criteria for listing under 22 CCR, Section 12306 or Section 12902, the following sub-list of 31 chemicals is provided. Anyone objecting to the listing of the chemicals identified under Section A below as causing cancer or causing reproductive toxicity on the basis that there is no substantial evidence that the criteria of sufficiency of evidence of carcinogenicity or reproductive toxicity identified in 22 CCR, Section 12306 have been satisfied, or to the listing of the chemicals identified in Section B below as causing reproductive toxicity on the basis that the criteria in 22 CCR, Section 12902 have not been met, should provide written comments in triplicate, along with supporting documentation, by mail or by fax to:
Office of Environmental Health Hazard Assessment
Post Office Box 4010
Sacramento, CA 95812-4010
Fax No.: (916) 327-1097
Telephone: (916) 445-6900
Comments may also be hand-delivered to the Office of Environmental Health Hazard Assessment at the same address.
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 5:00 PM on January 21, 1998.
A. The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing cancer under the authoritative bodies mechanism:
| Chemical | CAS No. | Reference |
|---|---|---|
| Aniline hydrochloride | 142-04-1 | US EPA (1989b) |
| C.I. Solvent Yellow 14 | 842-07-9 | NTP (1982a) |
| p-Chloroaniline hydrochloride | 20265-96-7 | NTP (1989a) |
| p-Chloro-o-toluidine and its strong acid salts | 95-69-2 | IARC (1990) |
| Cytembena | 21739-91-3 | NTP (1981) |
| 3,3' -Dichlorobenzidine dihydrochloride | 612-83-9 | NTP (1994) |
| Metham sodium | 137-42-8 | US EPA (1995a) |
| Methyl carbamate | 598-55-0 | NTP (1987) |
| Nalidixic acid | 389-08-2 | NTP (1989b) |
| o-Nitrotoluene | 88-72-2 | NTP (1996a) |
| o-Phenylenediamine and its salts | 95-54-5 | US EPA (1985) |
| Salicylazosulfapyridine | 599-79-1 | NTP (1997) |
| Phenolphthalein | 77-09-8 | NTP (1996b) FDA (1997) |
A. Chemicals determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing reproductive toxicity under the authoritative bodies mechanism:
| Benzo[a]pyrene | 50-32-8 | developmental toxicity | IARC (1983) |
| o,p' -DDT | 789-02-6 | developmental toxicity | IARC (1991) |
| male reproductive toxicity | NIOSH (1988) | ||
| female reproductive toxicity |
US EPA (1988a) |
||
| p,p' -DDT | 50-29-3 | developmental toxicity | IARC (1991) |
| male reproductive toxicity | NIOSH (1988) | ||
| female reproductive toxicity |
US EPA (1988a) |
||
| DDT, technical grade | --- | developmental toxicity | IARC (1991) |
| male reproductive toxicity | NIOSH (1988) | ||
| female reproductive toxicity |
US EPA (1988a) |
||
|
Endrin |
72-20-8 | developmental toxicity | US EPA (1980, 1992b) |
| Ethylene dibromide | 106-93-4 | developmental toxicity | NIOSH (1977) |
| male reproductive toxicity | US EPA (1987a,b) | ||
| Metham Sodium | 137-42-8 | developmental toxicity | US EPA (1994a,b) |
| Oxadiazon | 19666-30-9 | developmental toxicity | US EPA (1994a,b) |
| Vinclozolin | 50471-44-8 | developmental toxicity | US EPA (1994a,b; 1988b) |
|
Zearalenone |
17924-92-4 | male reproductive toxicity |
NTP (1982b) |
| female reproductive toxicity | IARC (1993) |
B. The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12902 for listing based on a formal requirement for labeling or identification as causing reproductive toxicity:
| Chemical | CAS No. | Toxicological Endpoints | References |
|---|---|---|---|
| Amoxapine | 14028-44-5 | developmental toxicity | FDA (1988a) |
| Beclomethasone dipropionate | 5534-09-8 | developmental toxicity | FDA (1988b) |
| Clobetasol propionate | 25122-46-7 | developmental toxicity female reproductive toxicity |
FDA (1995a) |
| Codeine phosphate | 52-28-8 | developmental toxicity | FDA (1989) |
| Flunisolide | 3385-03-3 | developmental toxicity female reproductive toxicity |
FDA (1984) |
| Fluticasone propionate | 80474-14-2 | developmental toxicity | FDA (1995b) |
| Histrelin acetate | --- | developmental toxicity | FDA (1991) |
| Levonorgestrel implants | 797-63-7 | female reproductive toxicity | FDA (1995c) |
- Ethylene dibromide
- DDT (Dichlorodiphenyltrichloroethane)
- Endrin
- p-Chloro-o-toluidine
- o-Phenylenediamine and its salts
- Methyl Carbamate
- Nalidixic Acid
- C.I. Solvent Yellow 14
- 3,3'-Dichlorobenzidine Dihydrochloride
- Cytembena
- Clobetasol Propionate
- Beclomethasone Dipropionate
- Aniline Hydrochloride
- Amoxapine
- Codeine Phosphate
- Histrelin Acetate
- Flunisolide
- Metham Sodium
- Fluticasone Propionate
- o,p'-DDT
- Oxadiazon
- Levonorgestrel Implants
- o-Nitrotoluene
- Phenolphthalein
- Vinclozolin
- p-Chloro-o-toluidine, strong acid salts of
- Sulfasalazine (salicylazosulfapyridine)
- Zearalenone
Chemical Reference
Related Notices
Footnotes and References
References
California Department of Food and Agriculture (CDFA, 1987) Summary of Toxicology Data: Oxadiazon. Medical Toxicology Branch. Last updated, 4/11/90.
California Department of Food and Agriculture (CDFA, 1986) Summary of Toxicology Data: Metam-Sodium. Medical Toxicology Branch. Last updated, 6/15/92.
Food and Drug Administration (FDA, 1988a). Final printed labeling for the drug amoxapine. FDA approved 1988.
Food and Drug Administration (FDA, 1988b). Final printed labeling for the drug beclomethasone dipropionate. FDA approved 1988.
Food and Drug Administration (FDA, 1995a). Final printed labeling for the drug clobetasol propionate. FDA approved 1995.
Food and Drug Administration (FDA, 1989). Final printed labeling for the drug codeine phosphate. FDA approved 1993.
Food and Drug Administration (FDA, 1984). Final printed labeling for the drug flunisolide. FDA approved 1984.
Food and Drug Administration (FDA, 1995b). Final printed labeling for the drug fluticasone propionate. FDA approved 1995.
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