Request for Information, Consideration for Possible Listing of Phenolphthalein via Administrative 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 phenolphthalein based upon the information in the references cited. Documentation summarizing the rationale for considering the evaluation of phenolphthalein for possible administrative listing is available from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from this link.
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 this chemical in the context of the Proposition 65 administrative listing regulatory criteria (22 CCR Section 12306).
On August 22, 1997, OEHHA published a notice in the California Regulatory Notice Register (CRNR) announcing chemicals under consideration for possible listing via administrative mechanisms. In the August 22nd notice, a public forum on Wednesday, October 1, 1997 was announced 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. An opportunity to provide oral comments and scientific information concerning phenolphthalein will also be made available on Wednesday, October 1, 1997. 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:
the Proposition 65 Office
Office of Environmental Health Hazard Assessment
301 Capitol Mall, 2nd Floor
Sacramento, California 95814
FAX: (916) 327-1097
Telephone: (916) 445-6900
In order to be considered, comments concerning phenolphthalein must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered or sent by fax) by Wednesday, November 12, 1997. All other comments for the chemicals announced in the August 22, 1997 CRNR notice must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered or sent by fax) by Tuesday, 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. Chemical 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 |
|---|---|---|
|
Phenolphthalein |
77-09-8 |
NTP, 1996 |
- Phenolphthalein
Chemical Reference
Footnotes and References
References:
National Toxicology Program (NTP, 1996). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
Food and Drug Administration (FDA, 1997). Minutes from the Carcinogenicity Assessment Committee (CAC) Meeting, April 30, 1997, US Department of Health and Human Services, Public Health Service, Food and Drug Administration.