Request for Information, 46 Chemicals Under Consideration for Possible Listing Via The Authoritative Bodies 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)]. 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) Section 12306.
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 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 from the Internet.
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 Wednesday, October 1, 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 Section 12902. The public forum will be conducted at 10:00 a.m. in the Auditorium at 714 P 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:
Cynthia Oshita
Office of Environmental Health Hazard Assessment
1001 I Street,
Sacramento, CA 95814
FAX: (916) 323-8803
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 October 21, 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" mechanism:
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| Aniline hydrochloride |
142-04-1 |
US EPA (1989b) |
| C.I. Solvent Yellow 14 |
842-07-9 |
NTP (1982a) |
| Carbon black (by inhalation) |
1333-86-4 |
IARC (1996) |
| 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) |
A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies" mechanism (continued):
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| Metham sodium1 |
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 (1996) |
| o-Phenylenediamine and its salts |
95-54-5 |
US EPA (1985) |
| Salicylazosulfapyridine |
599-79-1 |
NTP (1997) |
B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as reproductive toxicants via the "authoritative bodies" mechanism:
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| Acrylamide |
79-06-1 |
NIOSH (1991, 1992) NTP (1993a) |
| Benzo[a]pyrene |
50-32-8 |
IARC (1983) |
| Boric Acid1,2 |
10043-35-3 |
US EPA (1993a, b) |
| 1,3-Butadiene |
106-99-0 |
NIOSH (1984) US EPA (1989a) NTP (1993b) |
| Carbon dioxide (by inhalation)1,2 |
124-38-9 |
US EPA (1991a, b) |
| o,p-DDT |
789-02-6 |
IARC (1991) NIOSH (1988) US EPA (1988a) |
| p,p-DDT |
50-29-3 |
IARC (1991) NIOSH (1988) US EPA (1988a) |
| DDT, technical grade |
--- |
IARC (1991) NIOSH (1988) US EPA (1988a) |
| (2,4-dichlorphenoxy) acetic acid |
94-75-7 |
US EPA (1988c) |
| 2,4-D n-butyl ester |
94-80-4 |
US EPA (1988c) |
| 2,4-D isopropyl ester |
94-11-1 |
US EPA (1988c) |
| 2,4-D isooctyl ester |
25168-26-7 |
US EPA (1988c) |
| Propylene gylcol butyl ether ester (of 2,4-D) |
1928-45-6 |
US EPA (1988c) |
| 2,4-D butoxyethanol ester |
1929-73-3 |
US EPA (1988c) |
B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as reproductive toxicants via the "authoritative bodies" mechanism (continued):
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| 2,4-D dimethylamine salt |
2008-39-1 |
US EPA (1988c) |
| 2,4-D butyric acid1 |
94-82-6 |
US EPA (1988c, 1994a, b) |
| Endrin |
72-20-8 |
US EPA (1980, 1992b) |
| Ethylene dibromide |
106-93-4 |
NIOSH (1977) US EPA (1987a, b) |
| Linuron1 |
330-55-2 |
US EPA (1994a, b) |
| Metham Sodium1 |
137-42-8 |
US EPA (1994a, b) |
| Oxadiazon1 |
19666-30-9 |
US EPA (1994a, b) |
| Tetraborate and its salts (including Sodium Borate)1,2 |
--- |
US EPA (1993a, b) |
| Vinclozolin1 |
50471-44-8 |
US EPA (1988b, 1994a, b) |
| Zearalenone |
17924-92-4 |
NTP (1982b) IARC (1993) |
1On July 21, 1997 and August 4, 1997, letters were sent to the U.S. Environmental Protection Agency seeking clarification on its determination that the chemical had been identified as causing reproductive toxicity (see attached letters).
2On August 4, 1997, a letter was sent to the US Food and Drug Administration seeking clarification on its determination that the chemical had been identified as causing reproductive toxicity (see attached letter).
C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as reproductive toxicants via the "formally required to be labeled or identified" mechanism:
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| Amoxapine |
14028-44-5 |
FDA (1988a) |
| Beclomethasone dipropionate |
5534-09-8 |
FDA (1988b) |
| Clobetasol propionate |
25122-46-7 |
FDA (1995a) |
| Codeine phosphate |
52-28-8 |
FDA (1989) |
C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as reproductive toxicants via the "formally required to be labeled or identified" mechanism (continued):
|
Chemical |
CAS No. |
Reference |
|---|---|---|
| Flunisolide |
3385-03-3 |
FDA (1984) |
| Fluticasone propionate |
80474-14-2 |
FDA (1995b) |
| Histrelin acetate |
--- |
FDA (1991) |
| Levonorgestrel implants |
797-63-7 |
FDA (1995c) |
| Pravastatin sodium | 81131-70-6 | FDA (1996) |
- Benzo[a]pyrene
- 1,3-Butadiene
- Ethylene dibromide
- Linuron
- 2,4-D Butyric Acid
- DDT (Dichlorodiphenyltrichloroethane)
- Endrin
- Acrylamide
- p-Chloro-o-toluidine
- o-Phenylenediamine and its salts
- Methyl Carbamate
- Nalidixic Acid
- p-Chloroaniline Hydrochloride
- C.I. Solvent Yellow 14
- 3,3'-Dichlorobenzidine Dihydrochloride
- Cytembena
- Clobetasol Propionate
- Beclomethasone Dipropionate
- Aniline Hydrochloride
- Amoxapine
- Codeine Phosphate
- Carbon black (airborne, unbound particles of respirable size)
- Histrelin Acetate
- Flunisolide
- Metham Sodium
- Fluticasone Propionate
- o,p'-DDT
- Oxadiazon
- Levonorgestrel Implants
- o-Nitrotoluene
- Pravastatin sodium
- Vinclozolin
- p-Chloro-o-toluidine, strong acid salts of
- Sulfasalazine (salicylazosulfapyridine)
- Boric acid
- Carbon dioxide (by inhalation)
- 2,4-D n-Butyl Ester
- 2,4-D Isopropyl Ester
- 2,4-D Isooctyl Ester
- Propylene Glycol Butyl Ether Ester (of 2,4-D)
- 2,4-D Butoxyethanol Ester
- 2,4-D Dimethylamine Salt
- Zearalenone
Chemical Reference
- Oct 31, 2003
Related Notices
Footnotes and 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.
Food and Drug Administration (FDA, 1991). Final printed labeling for the drug histrelin acetate. FDA approved 1991.
Food and Drug Administration (FDA, 1995c). Final printed labeling for the drug levonorgestrel implants. FDA approved 1995.
Food and Drug Administration (FDA, 1996). Final printed labeling for the drug pravastatin sodium. FDA approved 1996.
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