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Notice of Intent to List Pulegone by the Labor Code Mechanism

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemical 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 pulegone meets the criteria for listing by this mechanism.

Chemical

CAS No.

Endpoint

References

Pulegone1

89-82-7

Cancer

IARC (2013)
Grosse et al. (2013)

1 Pulegone is a natural constituent of various plants, including mint and other herbs, and of their essential oils.

Background on listing by the Labor Code mechanism:

Labor Code: 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: Pulegone meets 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 pulegone is classified in Group 2B (the agent is “possibly carcinogenic to humans”). IARC concludes that there is “sufficient evidence of carcinogenicity in experimental animals” for pulegone (Grosse et al., 2013).

Opportunity for comment: OEHHA is providing this opportunity to comment as to whether the chemical identified above meets 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 this is a ministerial listing, 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 this chemical and will not respond to such comments if they are submitted.

OEHHA must receive comments by 5:00 p.m. on Monday, March 10, 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 “Pulegone NOIL” 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
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.

Link to Public Comments

The comment period closed on Monday, March 10, 2014.

Downloads

Footnotes and References

Grosse Y, Loomis D, Lauby-Secretan B, El Ghissassi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Baan R, Mattock H, Straif K on behalf of the International Agency for Research on Cancer Monograph Working Group. (2013). Carcinogenicity of some drugs and herbal products. The Lancet Oncology. Published online July 5, 2013, doi: 10.1016/S1470-2045(13)70329-2. [URL: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2813%2970329-2/fulltext.

International Agency for Research on Cancer (IARC, 2013). Agents Classified by the IARC Monographs, Volumes 1-108. Available at URL: http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf [Accessed July 16, 2013].

11Title 29, Code of Federal Regulations, section 1910.1200