Change of Basis for the Listing of Actinomycin D as a Chemical Known to the State of California to Cause Cancer

Effective February 22, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) changes the basis for the listing of actinomycin D (CAS No. 50-76-0) as a chemical known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65[1]).  The original effective date of listing of the chemical, which is October 1, 1989, remains the same. 

Actinomycin D was originally added to the Proposition 65 list as causing cancer via the Labor Code listing mechanism[2].  OEHHA changes the basis to the “formally required to be labeled or identified” listing mechanism[3] pursuant to the recent decision by the Third District Court of Appeal in The Styrene Information and Research Council v. The Office of Environmental Health Hazard Assessment[4].  (See also OEHHA’s Notice to Interested Parties Regarding Certain IARC 2B Chemicals, dated January 4, 2013.)  Actinomycin D has been identified or labeled to communicate a risk of cancer in accordance with formal requirements by the U.S. Food and Drug Administration (FDA). 

The documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for actinomycin D is included in the Notice of Intent to Change the Basis for Listing As Known to the State of California to Cause Cancer: Actinomycin D published in the January 4, 2013 issue of the California Regulatory Notice Register (Register 2013, No. 1-Z).

A complete, updated chemical list in the Excel format is posted and is available on the OEHHA website at www.oehha.ca.gov.

In summary, the following chemical is listed under Proposition 65 as known to the State to cause cancer with the new basis:

Chemical

CAS No.

Toxicological Endpoints

Listing Mechanism[5]

Actinomycin D

50-76-0

cancer

FR


Footnotes and References

[1] Health and Safety Code section 25249.5 et seq.

[2] Actinomycin D was listed as causing cancer on October 1, 1989 pursuant to Labor Code Section 6382(d) which is incorporated by reference as a Proposition 65 listing mechanism by Health and Safety Code section 25249.8(a), based on its identification by the International Agency for Research on Cancer (IARC) as a “Group 2B” carcinogen with less than sufficient animal and human evidence at the time of listing.

[3] See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25902.  All further references are to sections of Title 27, unless indicated otherwise.

[4] SIRC v. OEHHA (Nov. 15, 2012) Westlaw No. 5834844.

[5] Listing mechanism:

FR – “formally required to be labeled or identified” mechanism (Health and Safety Code section 25249.8(b) and Title 27 Cal. Code of Regs., section 25902.