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Anilazine, Naled, Quizalofop ethyl, Sodium nitrite, Triphenyltin hydroxide Found Not to Meet the Criteria for Listing

Candidates for Listing via the Authoritative Bodies Mechanism Found Not to Meet the Scientific Criteria (22 CCR 12306(g))

Requests for relevant information were made for sodium nitrite (California Regulatory Notice Register (CRNR), April 10, 1998), triphenyltin hydroxide (CRNR, October 9, 1998), and quizalofop ethyl (CRNR, October 30, 1998). An extension to the 60-day comment period for sodium nitrite and the other chemicals included in the April 10, 1998 notice was made until June 30, 1998 to allow for incorporation of comments which may have arose from the Authoritative Bodies Workshop held on June 11, 1998. No comments were received for triphenyltin hydroxide or quizalofop ethyl during these initial comment periods.

During the notice of intent to list phase for sodium nitrite (CRNR on December 4, 1998), the 30-day comment period was extended twice. The first time, a two-week extension was made to accommodate the December-January holiday season. A second two-week extension was made in response to heightened public interest that additional time was needed to prepare complete comments that address the complexity of the issues involved. Notices of intent to list were published in the CRNR on January 29, 1999, and February 26, 1999 for triphenyltin hydroxide and quizalofop ethyl, respectively. Comments were received for sodium nitrite, triphenyltin hydroxide and quizalofop ethyl.

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. Five of these chemicals are listed in the table below. A list of nine other chemicals not meeting these criteria was previously published (California Regulatory Notice Register (CRNR), March 19, 1999). In each case, the scientific criteria for "as causing reproductive "given in regulation (22 CCR 12306(g)) were not satisfied.

In accordance with 22 CCR 12306(i), three of the chemicals in the table, sodium nitrite, triphenyltin hydroxide, and quizalofop ethyl, will be referred to the Developmental and Reproductive Toxicant (DART) Identification Committee of the OEHHA Science Advisory Board because these determinations were made subsequent to the issuance of 3 separate notices of intent to list. 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. A CRNR notice for naled (November 20, 1998) announced that the regulatory criteria for listing under Proposition 65 may have been met. However, because a notice of intent to list was not issued, it will not be referred to the DART Identification Committee for its review on this basis at this time.

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

Chemical

CAS No.
Anilazine

101-05-3
Naled

300-76-5
Quizalofop ethyl

76578-14-8
Sodium nitrite

7632-00-0
Triphenyltin hydroxide

76-87-9

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 download area below. Questions regarding this notice should be directed to:

Ms. Cynthia Oshita
Office of Environmental Health Hazard Assessment
Post Office Box 4010
Sacramento, CA 95812-4010
Fax No.: (916) 327-1097
Telephone: (916) 445-6900

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