CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF ENVIRONMENTAL H EALTH HAZARD ASSESSMENT

SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 (Proposition 65)

NOTICE TO INTERESTED PARTIES January 17, 2003

CHEMICAL DELISTED EFFECTIVE January 17, 2003

FROM THE LIST OF CHEMICALS AS KNOWN TO THE STATE OF CALIFORNIA

TO CAUSE CANCER

CHEMICAL LISTED EFFECTIVE January 17, 2003

AS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE REPRODUCTIVE TOXICITY

The Office of Environmental Health Hazar d Assessment (OEHHA) of the California Environmental Protection Agency is removing sodium saccharin from the list of chemicals known to the State to cause cancer and adding a new endpoint, male reproductive toxicity, for

bromacil lithium salt , a chemical on the list of chemicals known to the State to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing for male reproductive toxicity of bromacil lithium salt and the delisting of sodium saccharin are effective January 17, 2003.

Bromacil lithium salt (CAS # 53404-19-6) was previously listed as a chemical known to the State to cause developmental toxicity on May 18, 1999, under the authoritative bodies provision of Proposition 65. It was formally identified by U. S. Environmental Protection Agency (U.S. EPA) as causing developmental toxicity. Subsequent to the listing of the chemical, OEHHA found that there was no substantial evidence that the criteria identified in Title 22, California Code of Regulations, Section 12306(g) (22 CCR §12306(g)) has been satisfied. This finding was the consequence of the Court of Appeal decision restricting the review of evidence by OEHHA of authoritative bodies listing [Third District Court of Appeal, Western Crop Protection Association et al. v. Gray Davis et al. (Case No. CO29727, May 9, 2000 as modified on denial of rehearing, June 8, 2000).] As required by regulation, bromacil lithium salt was referred to the Developmental and Reproductive Toxicant (DART) Identification Committee for

a determination as to whether the chemical should continue to be included on the list of chemicals known to the state to cause reproductive toxicity (22 CCR §12306(j)). At the December 4, 2002 meeting, the DART Identification Committee determined that bromacil

lithium salt should remain on the list of chemicals as known to the State to cause developmental toxicity and should also be listed for male reproductive toxicity.

Sodium saccharin (CAS No. 128-44-9) was considered by the “state’s qualified experts” (the Carcinogen Identification Committee) for removal from the list of chemicals known to the State to cause cancer at a public meeting held on December 17, 2002. Sodium saccharin was first added to the list of chemicals known to the State to cause cancer on January 1, 1988, as a resultof actions taken by the “state’s qualified experts” (the former Scientific Advisory Panel) at a December 11, 1987 public meeting. The Carcinogen Identification Committee determined that sodium saccharin is no longer clearly shown through scientifically valid testing according to generally accepted principles to cause cancer and should be removed from the list of chemicals

known to the State to cause cancer.

The reader is directed to the Notice to Interested Parties published in the September 20, 2002

issue of the California Regulatory Notice Register (Register 02, No. 38-Z) for the supporting documentation which the DART Identification Committee relied upon in its reconsideration of listing bromacil lithium salt. The reader is directed to another Notice to Interested Parties published in the October 11, 2002 issue of the California Regulatory Notice Register (Register 02, No. 41-Z) for the supporting documentation which the Carcinogen Identification Committee relied upon in its reconsideration of listing sodium saccharin.

A complete, updated chemical list is published elsewhere in this issue of the California Regulatory Notice Register

.

In summary, in addition to the current listing as known to the State to cause developmental toxicity, bromacil lithium salt, is added to the Proposition 65 chemical list as known to the State to cause male reproductive toxicity :

Reproductive toxicity

Chemical CAS No. Toxicological
Endpoint Listing

Mechanism 1 Effective Listing

Date

Bromacil lithium

salt 53404-19-6 Developmental Male reproductive toxicity AB SQE May 18, 1999 January 17, 2003

_____________________________ 1 Listing mechanism: AB – “authoritative bodies” mechanism (22 CCR 12306) SQE – “state’s qualified experts” mechanisms (22 CCR 12305(b)(1))