OEHHA Proposes Prop 65 Listing Under Labor Code Mechanism

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Source: Acta Group

March 9, 2011 -- On March 4, 2011, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed to list four chemicals as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) under the 'Labor Code mechanism' for listing contained in Health and Safety Code Section 25249.8(a). The four substances are:

Chemical CAS No. Endpoint Reference
Cyclopenta[cd]pyrene 27208-37-3 Cancer (2010a; 2010b)
Ethanol in alcoholic beverages Cancer IARC (2010a; 2010c)
Leather dust Cancer IARC (2010a)
Salted fish, Chinese-style Cancer IARC (2010a)

This is the first time that OEHHA has proposed to list substances under the Labor Code mechanism since June 12, 2009, when OEHHA announced its intent to add 30 chemicals to Prop 65 based on the Labor Code mechanism. That announcement followed OEHHA's May 1998 issuance of a document, Request for Public Participation, Notice of Public Workshop, Proposition 65 Regulatory Update Project - Labor Code Mechanism Regulatory Concept (Regulatory Concept), stating its position for why chemicals or substances identified by reference to Labor Code Sections 6382(b)(1) or 6382(d) as known to cause cancer or reproductive toxicity must be included on the Prop 65 list without any further scientific input from impacted stakeholders. Labor Code Section 6382(b)(1) references chemicals identified as carcinogens by the International Agency for Research on Cancer (IARC), while Labor Code Section 6382(d) references chemicals listed pursuant to the federal Hazard Communications Standard (HCS), under regulations found at 29 C.F.R. Section 1910.1200, which includes known and probable carcinogens identified by IARC, substances identified as known or probable carcinogens by the National Toxicology Program (NTP), and several other substances identified as carcinogens by the federal Occupational Safety and Health Act (OSHA).

At the time of OEHHA's Regulatory Concept and June 12, 2009, proposed listings, industry stakeholders raised significant concern with use of the listing mechanism, claiming that OEHHA's proposal created an entirely new listing mechanism that OEHHA was not legally authorized to create and was unnecessary considering the other listing mechanisms available to and currently relied upon by OEHHA. When OEHHA has listed substances under Prop 65, it has generally relied on three other mechanisms: (1) identification by the State's qualified experts; (2) identification by the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and other authoritative bodies; and (3) formally required to be listed by a federal or state agency. In 2009, the Alameda County Superior Court issued decisions upholding OEHHA's position and finding that Prop 65 imposed a 'clear ministerial duty' on OEHHA to list substances known to cause cancer or reproductive toxicity as identified by reference to the Labor Code. Sierra Club v. Schwarzenegger, No. RG 07-356881 (Cal. Super. Ct. Apr. 24, 2009); Sierra Club v. Schwarzenegger, No. RG 07-356881 (Cal. Super. Ct. May 27, 2009). Appeals regarding these decisions are still ongoing.

In OEHHA's March 4, 2011, notice, OEHHA states that three of the four substances proposed for listing (ethanol in alcoholic beverages, leather dust, and salted fish, Chinese-style) have been identified by IARC as Group 1 (the agent is carcinogenic to humans) and the fourth substance proposed for listing (Cyclopenta[cd]pyrene) is identified by IARC as Group 2A (probably carcinogenic to humans). In comments that were submitted to OEHHA with regard to its June 2009 proposed listings, concerns had been raised that OEHHA could propose to list under the Prop 65 Labor Code mechanism when IARC identified a substance as Group 2B (possibly carcinogenic to humans) even though under that categorization IARC could designate a substance based on insufficient evidence of carcinogenicity in humans or experimental animals and that lack of evidentiary sufficiency would not even support a listing decision via the Authoritative Body mechanism under Prop 65.

Comments on OEHHA's March 4, 2011, notice must be received by 5:00 p.m., Monday, April 4, 2011. OEHHA states:

Because these are ministerial listings, comments should be limited to the question 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 identifying a specific chemical or substance and will not respond to such comments if they are submitted.

The availability of this listing mechanism sets a dangerous precedent. Because of the ease with which chemicals can be listed under Prop 65, this mechanism could easily become OEHHA's listing mechanism of choice. As noted above, chemicals could be added to the Prop 65 list using the Labor Code mechanism even though under other listing mechanisms, chemicals could not be added to the list.

OEHHA's March 4, 2011, Notice of Intent to List is available online. OEHHA's Regulatory Concept is available online.

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