Notice of Intent to List: Avermectin B1, Delta isomer of avermectin B1, N-Methylpyrrolidone, and Imazalil

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 cancer or reproductive toxicity (Health and Safety Code Section 25249.8(b)). One such mechanism by which a chemical may be 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 are identified as authoritative bodies for purposes of Proposition 65 as it pertains to chemicals known to cause reproductive toxicity: the US Environmental Protection Agency (US EPA), the International Agency for Research on Cancer (for transplacental carcinogenicity only), the US Food and Drug Administration, and the National Institute for Occupational Safety and Health. The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations (22 CCR), Section 12306.

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency intends to list the chemicals identified in the table below as known to the State to cause reproductive toxicity, pursuant to this administrative mechanism as provided in Health and Safety Code Section 25249.8(b) and 22 CCR, Section 12306.

Relevant information on avermectin B1 and the delta-8,9-isomer of avermectin B1 were requested in a notice published in the California Regulatory Notice Register on October 9, 1998. A similar notice was published on N-methylpyrrolidone on October 30, 1998, and on imazalil on December 24, 1998. Public forums were held on November 11, 1998, December 18, 1998, and January 21, 1999, respectively. Public comments were received on all four of these chemicals. OEHHA has completed its review of the comments and has determined the chemicals meet the criteria for listing under 22 CCR, Section 12306, and is issuing this notice of intent to list for these chemicals. A document providing more detail on the basis for the listing can be obtained from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below or from this web site. Anyone objecting to the listing of the chemicals identified below as causing reproductive toxicity on the basis that there is no substantial evidence that the criteria of sufficiency of evidence of reproductive toxicity identified in 22 CCR, Section 12306 have been satisfied should provide written comments in triplicate, along with supporting documentation, by mail or by fax 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

Comments may also be hand-delivered to the Office of Environmental Health Hazard Assessment at the same address.

In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if delivered in person or sent by FAX) by 5:00 p.m. on Monday, May 24, 1999.

The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing reproductive toxicity under the authoritative bodies mechanism:

Chemical

CAS No.

Toxicological Endpoint

Referencea

Avermectin B1

71751-41-2

65195-55-3

65195-56-3

developmental toxicity US EPA (1994a,b, 1996)
Delta-8,9-isomer of Avermectin B1

---

developmental toxicity US EPA (1996)
N-Methylpyrrolidone

872-50-4

developmental toxicity US EPA (1994a,b)
Imazalil

35554-44-0

developmental toxicity US EPA (1994a,b)

a Formal identification by US EPA of chemicals causing reproductive toxicity is provided in US EPA (1994b) below, while additional information on the basis for such identification is provided in US EPA (1994a).

Footnotes and References

References
US Environmental Protection Agency (US EPA, 1994a) Proposed Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59 FR 1788).

US Environmental Protection Agency (US EPA, 1994b). Final Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59 FR 61432).

US Environmental Protection Agency (US EPA, 1996). Final Rule: Pesticide Tolerance; Avermectin B1 and its Delta-8,9-Isomer. Federal Register (61 FR 9350).