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California Environmental Protection Agency's Office of Environmental Health Hazard Assessment Issues Notice of Intent to List PFOA and PFOS

On September 16, 2016, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA is proposing the action under the authoritative bodies' listing mechanism.

Comments are due October 17, 2016. If PFOA and PFOS are listed, warning requirements under the new regulatory scheme would be triggered one year from the date of OEHHA's listing.

Authoritative Body Listing

To be listed under Prop 65 under the authoritative bodies mechanism: (1) an authoritative body must formally identify the chemical as causing reproductive toxicity (Title 27, California Code of Regulations Section 25306(d)); and (2) the evidence considered by the authoritative body must meet the scientific sufficiency criteria contained in the regulations (Section 25306(g)). Under Section 25306(d), an authoritative body has formally identified a chemical as causing cancer or reproductive toxicity when certain criteria are met. First, under Section 25306(d)(1), one of three activities must take place:

  1. The chemical has been included on a list of chemicals causing cancer or reproductive toxicity issued by the authoritative body; or

  2. The chemical is the subject of a report which is published by the authoritative body and which concludes that the chemical causes cancer or reproductive toxicity; or

  3. The chemical has otherwise been identified as causing cancer or reproductive toxicity by the authoritative body in a document that indicates that such identification is a final action.

Second, under Section 25306(d)(2), the list, report, or document specifically and accurately identifies the chemical, and has been:

  1. Reviewed by an advisory committee in a public meeting, if a public meeting is required; or

  2. Made subject to public review and comment prior to its issuance; or

  3. Published by the authoritative body in a publication, such as, but not limited to, the Federal Register for an authoritative body which is a federal agency; or

  4. Signed, where required, by the chief administrative officer of the authoritative body or a designee; or

  5. Adopted as a final rule by the authoritative body; or

  6. Otherwise set forth in an official document utilized by the authoritative body for regulatory purposes.

PFOA and PFOS meet the criteria, according to OEHHA, for listing as known to the state to cause reproductive toxicity under Prop 65, based on findings of the U.S. Environmental Protection Agency (EPA).

Basis for PFOA Listing

With regard to PFOA, OEHHA states that EPA's 2016 documents Drinking Water Health Advisory (HA) for PFOA and Health Effects Support Document for PFOA "contain conclusions about the developmental toxicity of PFOA, referencing studies in which developmental toxicity results entirely or predominantly from prenatal exposure to the chemical." OEHHA states these documents meet the Section 25306(d)(1) criteria, because PFOA "'is the subject of a report which is published by the authoritative body and which concludes that the chemical causes...reproductive toxicity,' and because PFOA 'has otherwise been identified as causing ... reproductive toxicity by the authoritative body in a document that indicates that such identification is a final action.'" The latter criterion is met by the development by EPA of a lifetime drinking water HA for PFOA, based on a reference dose (RfD) derived from developmental toxicity in mice.

OEHHA states that three of the six criterion under Section 25306(d)(2) have been meet because the documents either have been "published by the authoritative body in a publication, such as, but not limited to, the federal register," "reviewed by an advisory committee in a public meeting, if a public meeting is required," and/or "made subject to public review and comment prior to its issuance." OEHHA states that the documents also meet the sufficiency of evidence criteria in Section 25306(g), citing several statements that OEHHA believes document EPA's conclusions about developmental toxicity. Based on the documents, as well as the studies cited therein, OEHHA concludes it "finds the criteria for listing PFOA through the authoritative bodies mechanism as causing reproductive toxicity (developmental endpoint) have been met."

Basis for PFOS Listing

With regard to PFOS, OEHHA states that EPA's documents Drinking Water Heath Advisory for PFOS and Health Effects Support Document for PFOS "make conclusions about the developmental toxicity of PFOS, referencing studies in which prenatal exposure to the chemical results in developmental toxicity." OEHHA states the Section 25306(d)(1) criteria are satisfied because PFOS "'is the subject of a report which is published by the authoritative body and which concludes that the chemical causes...reproductive toxicity,' and because PFOS 'has otherwise been identified as causing ... reproductive toxicity by the authoritative body in a document that indicates that such identification is a final action.'" The latter criterion is met by the development by EPA of a lifetime drinking water HA for PFOS, based on a RfD derived from developmental toxicity in rats.

OEHHA states that Section 25306(d)(2) criteria are met because the documents have either been "published by the authoritative body in a publication, such as, but not limited to, the federal register," "reviewed by an advisory committee in a public meeting, if a public meeting is required," and/or "made subject to public review and comment prior to its issuance." OEHHA states that the documents also meet the sufficiency of evidence criteria in Section 25306(g), citing several statements that OEHHA believes document EPA's conclusions about developmental toxicity. Based on the documents, as well as the studies cited therein, OEHHA concludes it "finds the criteria for listing PFOS through the authoritative bodies mechanism as causing reproductive toxicity (developmental endpoint) have been met."

Commentary

OEHHA seeks comments on whether PFOA and PFOS meet the authoritative bodies' listing criteria. Comments are due October 17, 2016. After reviewing submitted comments, OEHHA must find that the Section 25306(g) sufficiency of evidence criteria was not met if it is demonstrated that scientifically valid data were not considered by the authoritative body. If PFOA and PFOS are listed, warning requirements under the new regulatory scheme would be triggered one year from the date of OEHHA's listing.

©2019 Bergeson & Campbell, P.C.

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Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. A coalition of companies and trade associations committed to enhancing the legal and regulatory positioning of biobased products formed the Biobased and Renewable Products Advocacy Group (BRAG) to address issues specific to biobased chemical products and, in particular, the...

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