Comment Period - Notice of Intent to List Pentosan polysulfate sodium, Pioglitazone, Triamterene as Known to Cause Cancer by the Labor Code Mechanism
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemicals identified in the table below as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. The Act, commonly known as Proposition 65, is codified in Health and Safety Code section 25249.5 et seq. This action is being taken pursuant to the Labor Code mechanism contained in Health and Safety Code section 25249.8(a). OEHHA has determined that pentosan polysulfate sodium, pioglitazone, and triamterene meet the criteria for listing by this mechanism.
|
Chemical |
CAS No. |
Endpoint |
References |
|---|---|---|---|
|
Pentosan polysulfate sodium |
--- |
Cancer |
IARC (2013); |
|
Pioglitazone |
111025-46-8 |
Cancer |
IARC (2013); |
|
Triamterene |
396-01-0 |
Cancer |
IARC (2013); |
Background on listing by the Labor Code mechanism: Health and Safety Code section 25249.8(a) incorporates California Labor Code Sections 6382(b)(1) and 6382(d) into Proposition 65. The law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65. Labor Code section 6382(b)(1) refers to substances identified as human or animal carcinogens by IARC. Labor Code section 6382(d) refers to chemicals that are within the scope of the federal Hazard Communications Standard. The Federal Hazard Communications Standard1 requires chemical manufacturers and employers to provide Safety Data Sheets (SDS) with hazardous chemicals. One of the mandatory requirements for the SDS is to disclose in Section 11 (the “toxicological information” section), “whether the hazardous chemical…has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest edition) …”. An explanation of the carcinogenicity classifications used by IARC, and the Monographs development and peer review by the international working groups of scientific experts convened by IARC, may be found at the following URL: http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf .
As the lead agency for the implementation of Proposition 65, OEHHA evaluates whether chemical listings are required by Proposition 65.
OEHHA’s determination: Pentosan polysulfate sodium, pioglitazone, and triamterene each meet the requirements for listing as known to the state to cause cancer for purposes of Proposition 65 under the Labor Code listing mechanism.
IARC has published on its website a list entitled “Agents classified by the IARC Monographs, Volume 1-108" (IARC, 2013). IARC concludes that pioglitazone is classified in Group 2A (the agent is “probably carcinogenic to humans”) and pentosan polysulfate sodium, and triamterene are each classified in Group 2B (the agent is “possibly carcinogenic to humans”). IARC concludes that there is “sufficient evidence of carcinogenicity in experimental animals” for pentosan polysulfate sodium, pioglitazone, and triamterene (Grosse et al., 2013).
Opportunity for comment: OEHHA is providing this opportunity to comment as to whether the chemicals identified above meet the requirements for listing as causing cancer specified in Health and Safety Code section 25249.8(a) and Labor Code sections 6382(b)(1) or 6382(d) or both. Because these are ministerial listings, comments should be limited to whether IARC has identified the specific chemical or substance as a known or potential human or animal carcinogen. Under this listing mechanism, OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by IARC when it identified these chemicals and will not respond to such comments if they are submitted.
OEHHA must receive comments by 5:00 p.m. on Tuesday, April 1, 2014. 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, and should include “NOIL” and the chemical name in the subject line. Comments submitted in paper form may be mailed, faxed, or delivered in person to the address below.
Mailing Address: Sam Delson
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-2265
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.