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Proposition 65

Chemicals Under Consideration for Possible Listing Via Administrative Mechanisms: Revision of the March 28, 1997 Notice (withdrawal of Premarin from consideration)

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) 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 of chemicals through this mechanism are set forth in 22 CCR Section 12902.

In a notice published in the California Regulatory Notice Register on March 28, 1997, Premarin (CAS No. 12126-59-9) was identified as under investigation for possible listing as both a carcinogen and a reproductive toxicant, on the basis of a formal requirement for labeling imposed by the Food and Drug Administration (FDA., 1995). OEHHA has determined that no further action towards listing of Premarin is appropriate at this time, since it is already covered by previous listings of conjugated estrogens as carcinogens and reproductive toxicants.

Food and Drug Administration (FDA, 1995). Final printed labeling for the drug premarin. FDA approved September 1995.

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