CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF ENVIRONMENTAL HEALTH 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 Hazard 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 result 
of 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 

Mechanism1

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))