Release of EPA’s Draft Health Effects Documents for PFOA and PFOS

The U.S. Environmental Protection Agency (EPA) has prepared draft health effects documents for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) for purposes of public comment (scientific views) and peer review. EPA will consider any public comments and peer reviewer comments submitted in accordance with the Federal Register notice (February 28, 2014) when finalizing the documents. Once the health effects documents are finalized, they will be utilized to develop lifetime health advisory values for each chemical. PFOA and PFOS are listed on the third contaminant Candidate List (CCL3)1 and both chemicals are currently being monitored under the third Unregulated Contaminant Monitoring Rule (UCMR3)2.

The draft health effects documents and charge questions may be downloaded by clicking the links below. Additionally, the documents may be accessed through the EPA public docket at http://www.regulations.gov (Docket ID No. EPA-HQ-OW-2014-0138).

Health Effects Document for Perfluorooctanoic Acid (PDF)
Health Effects Document for Perfluorooctane Sulfonate (PDF)
Peer Reviewer Charge Questions (PDF)

For additional information on the public comment period, please view the Federal Register notice released on February 28, 2014 or go to the Public Comment Period site.

Scientific Peer Review Process

Versar, Inc., an EPA contractor, is organizing and conducting an external peer review of EPA’s draft health effects documents for PFOA and PFOS. As part of the peer review, Versar will assemble six to seven experts who will review the draft documents and participate in a two-day peer review meeting in the Washington, DC metro area. The peer review selection process will be initiated with a public nomination period, during which members of the public will be able to nominate scientific experts with knowledge and experience in one or more of the following areas: (1) epidemiology, (2) toxicology (liver effects, immunotoxicity, neurotoxicity, developmental and reproductive toxicology, etc.), (3) membrane transport, (4) human health risk assessment, (5) pharmacokinetic models, and (6) mode-of-action for cancer and noncancer effects. Versar may also conduct an independent search for scientific experts to augment the list of publically-nominated candidates.

Versar will consider and screen all candidates against the selection criteria described in the Federal Register, which includes having demonstrated expertise in the areas described above, being free of any conflict of interest, and being available to participate in-person in a two-day peer review meeting in the Washington, DC area (exact date to be determined). Following the screening process, Versar will narrow the list of potential reviewers to 12-15 candidates. Prior to selecting the final peer reviewers, a second Federal Register notice will be published (exact date to be determined) to solicit public comments on the interim list of 12-15 candidates. The public will be requested to provide relevant information or documentation on the nominees that Versar should consider in evaluating the candidates. Once the public comments on the interim list of candidates have been reviewed, Versar will select the final six to seven peer reviewers who, collectively, best provide expertise spanning the multiple areas listed above and, to the extent feasible, best provide a balance of perspectives.

Following the selection process, Versar will task the peer reviewers with evaluating and providing written comments on the draft documents. Additionally, peer reviewers will be provided a summary of public comments and given access to public comments submitted during the draft document’s public comment period.

Versar will also coordinate the external peer review meeting in the Washington, DC metro area. The two-day meeting will take place in July or August 2014 (exact date to be determined). A Federal Register notice will be published at least 30 days prior to the external peer review meeting to provide the meeting date, location, and registration information. Subsequently, Versar will provide a peer review summary report to EPA containing the final comments and recommendations from the peer reviewers. The final peer review report will also be made available to the public.

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1 CCL3 is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, that are known or anticipated to occur in public water systems, and which may require regulation under the Safe Drinking Water Act (SDWA). Additional information about the CCL3 can be found at the following website: http://water.epa.gov/scitech/drinkingwater/dws/ccl/ccl3.cfm.

2 EPA uses the Unregulated Contaminant Monitoring (UCM) program to collect data for unregulated contaminants suspected to be present in drinking water. Results from UCMR3 can be examined as they become available at the following website: http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/.