Comment Period - Notice of Intent to Change the Basis for Listing as Known to the State of California to Cause Cancer: Actinomycin D
OEHHA’s determination: 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).
Language from the FDA-approved product label which meets the requirements of Section 25902 is quoted below:
Actinomycin D
Cancer Endpoint (Under boxed WARNING and WARNINGS)
Under boxed WARNING: “Due to the toxic properties of dactinomycin [actinomycin D] (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently.”
Under WARNINGS: “Reports indicate an increased incidence of second primary tumors (including leukemia) following treatment with radiation and anti-neoplastic agents, such as COSMEGEN [actinomycin D]. Multi-modal therapy creates the need for careful, long-term observation of cancer survivors.”
Request for comments: OEHHA is requesting comments as to whether this chemical meets the criteria set forth in the Proposition 65 regulations for listings via the formally required to be labeled or identified mechanism (Section 25902). Because these are ministerial listings, comments should be limited to whether FDA requires that Actinomycin D be labeled to communicate a risk of cancer or reproductive harm. OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by FDA when it established the labeling requirement and will not respond to such comments if they are submitted.
In order to be considered, OEHHA must receive comments by 5:00 p.m. on MONDAY, FEBRUARY 4, 2013. We encourage you to submit comments in electronic form, rather than in paper form. Comments transmitted by e-mail should be addressed to P65Public.comments@oehha.ca.gov. Please include “actinomycin D” in the subject line. Comments submitted in paper form may be mailed, faxed, or delivered in person to the address below.
Mailing Address:
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916)323-8803
Street Address:1001 I Street
Sacramento, California 95814
Any public comments received will be posted after the close of the comment period. If you have any questions, please contact Sam Delson at sam.delson@oehha.ca.gov or at (916) 445-6900.