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Proposition 65

Chemicals Under Consideration for Possible Listing via the Administrative Mechanisms: Request for Relevant Information
[09/29/00]

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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. For carcinogenicity, the US Environmental Protection Agency (US EPA), the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH) have been identified as authoritative bodies for purposes of the Act. The criteria for listing chemicals through the "authoritative bodies" mechanism Section 12306.

The second mechanism for the administrative listing of a chemical applies if an agency of state or federal government 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 at the following address: http://www.oehha.ca.gov/.

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, October 26, 2000, 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 begin at 10:00 a.m. at 1515 Clay Street, Elihu Harris State Building, Conference Room A, Oakland, California and will last 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:

the Proposition 65 Office
Office of Environmental Health Hazard Assessment
1001 I Street,
Sacramento, CA 95814

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 5:00 p.m. Tuesday, November 28, 2000.

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 known to cause carcinogenicity via the "authoritative bodies" mechanism:

Chemical CAS No. Reference

Catechol

120-80-9

IARC (1999a)

DEF (S,S,S-tributyl phosphorotrithioate; Tribufos)

78-48-8

U.S. EPA (1997c)

Ethoprop

13194-48-4

U.S. EPA (1997a)

Indium phosphide

22398-80-7

NTP (2000a; 2000c)

Lynestrenol

52-76-6

IARC (1999b)

Naphthalene

91-20-3

NTP (2000b; 2000c)

Norethynodrel

68-23-5

IARC (1999b)

Propachlor

1918-16-7

U.S. EPA (1997b)

Strong inorganic acid mists containing sulfuric acid

7664-93-9 (sulfuric acid)

NTP (2000d)

B. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as known to cause cancer and/or reproductive toxicity via the "formally required to be labeled or identified" mechanism:

Chemical CAS No. Toxicological Endpoints References

Albuterol

18559-94-9

Developmental toxicity

FDA (1986)

Amantadine hydrochloride

665-66-7

Developmental toxicity

FDA (1993a)

Atorvastatin calcium

134523-03-8

Developmental toxicity

FDA (1998a)

Diazoxide

364-98-7

Developmental toxicity

FDA (1994a)

Dichlorphenamide

120-97-8

Developmental toxicity

FDA (1994b)

Diltiazem hydrochloride

42399-41-7

Developmental toxicity

FDA (1996b)

Famciclovir

104227-87-4

Male reproductive toxicity

FDA (1997a)

Felodipine

72509-76-3

Developmental toxicity Female reproductive toxicity

FDA (1998b)

Filgrastim

121181-53-1

Developmental toxicity

FDA (1992)

Fluvastatin sodium

93957-55-0

Developmental toxicity Male reproductive toxicity

FDA (1999)

Nimodipine

66085-59-4

Developmental toxicity

FDA (1996c)

Ribavirin*

36791-04-5

Male reproductive toxicity

FDA (1993b)

Rifampin

13292-46-1

Developmental toxicity Female reproductive toxicity

FDA (1997b)

Trientine hydrochloride

38260-01-4

Developmental toxicity

FDA (1988)

* Ribavirin was added to the list of chemicals known to cause reproductive toxicity on the basis of a developmental toxicity endpoint on April 1, 1990.

Follow this link to download the documentation on the chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as known to cause carcinogenicity via the "authoritative bodies"

Follow this link to download the documentation on chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as known to cause cancer and/or reproductive toxicity via the "formally required to be labeled "mechanism

Follow this link to download a copy of this notice.


References

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California Department of Pesticide Regulation (1999). Evaluation of S,S,S-Tributyl phosphorotrithioate (DEF) as a Toxic Air Contaminant. Part C. Human Health Assessment found at URL http://www.cdpr.ca.gov/docs/empm/pubs/def/defaircn.htm.

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