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Fenbutatin Oxide Found Not to Meet Scientific Criteria for Listing

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 reproductive toxicity or cancer (Health and Safety Code Section 25249.8(b)). One such mechanism involves the listing of chemicals that a body, considered to be authoritative by the state’s qualified experts, formally identifies as causing cancer or reproductive toxicity. As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency reviews candidates for listing pursuant to this administrative mechanism as provided in Health and Safety Code Section 25249.8(b) and Title 22, California Code of Regulations, Section 12306 (22 CCR 12306).

The U.S. Environmental Protection Agency (U.S. EPA), an authoritative body for purposes of Proposition 65 (22 CCR Section 12306(l)), identifies chemicals as causing developmental or reproductive toxicity in implementing its Toxic Release Inventory (TRI) program (i.e., Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA)). On this basis the U.S. EPA, in 1994, added a number of chemicals to the TRI list and published its inclusions to the list in the Federal Register (59:1788-1859, 1994 and 59:61432-61485, 1994). OEHHA has reviewed the bases for these TRI chemical additions in the context of the regulatory criteria governing Proposition 65 listing via the authoritative bodies mechanism (22 CCR 12306).

OEHHA determined for several TRI chemicals that the 22 CCR 12306 regulatory criteria were met and is in the process of placing these chemicals on the Proposition 65 list of chemicals known to cause reproductive toxicity. OEHHA has determined that these same regulatory criteria have not been met for some of the chemicals added by U.S. EPA in 1994 to the TRI list on the basis of reproductive or developmental toxicity. One of these chemicals is listed in the table below. Three other lists of chemicals (nine chemicals, five chemicals, and two chemicals) not meeting these criteria were previously published (California Regulatory Notice Register (CRNR), March 19, 1999; May 21, 1999; and June 18, 1999, respectively). In each case, the scientific criteria for "as causing reproductive toxicity" given in regulation  CCR 12306(g)) were not satisfied.

In accordance with 22 CCR 12306(i), the chemical will be referred to the Developmental and Reproductive Toxicant (DART) Identification Committee of the OEHHA Science Advisory Board because the determination was made subsequent to the issuance of a notice of intent to list (CRNR, January 29, 1999). Therefore, at a future meeting, the DART Identification Committee will opine whether "the chemical has been clearly shown through scientifically valid testing according to generally accepted principles". Therefore, at a future meeting, the DART Identification Committee will opine whether "the chemical has been clearly shown through scientifically valid testing according to generally accepted principles" to cause reproductive toxicity.

TRI chemical not meeting the scientific criteria (22 CCR 12306(g)) for authoritative bodies listing as causing reproductive toxicity under Proposition 65

Chemical

CAS No.
Fenbutatin oxide

13356-08-6
 

A document providing more detail on the basis for this determination can be obtained from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the downloads section below. Questions regarding this notice should be directed to:

Proposition 65 Office
Office of Environmental Health Hazard Assessment
Post Office Box 4010
Sacramento, CA 95812-4010

Fax No.: (916) 327-1097
Telephone: (916) 445-6900

P65Public.Comments@oehha.ca.gov

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