Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


Systematic Review of Immunotoxicity Associated With Exposure to PFOA or PFOS; Request for Information and Nominations of Scientific Experts for Proposed Peer Review Meeting

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences is evaluating the scientific evidence regarding the association between exposures to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) and immunotoxicity. OHAT invites the submission of information about ongoing studies or upcoming publications on the immune-related health effects of PFOA or PFOS that might be considered for inclusion in the evaluation. OHAT also invites the nomination of scientific experts to potentially serve as members of an ad hoc expert panel to be convened to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity.


The deadline for receipt of information and nominations of scientific experts is September 30, 2015.


Information can be submitted to

Start Further Info


Dr. Yun Xie, NTP Designated Federal Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-3436, Fax: (301) 451-5455, Email: Hand Delivery/Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560.

End Further Info End Preamble Start Supplemental Information


Background on PFOA and PFOS: PFOA and PFOS are persistent chemicals that are widely distributed in the environment in part because of high stability and little to no expected degradation in the environment. In terms of toxicity and exposure, PFOA and PFOS are the best studied perfluoroalkyl acids, a group of compounds used extensively over the last 50 years in commercial and industrial applications including food packaging, lubricants, water-resistant coatings, and fire-retarding foams. Through voluntary agreements, the primary manufacturer of PFOS phased out production in 2002, and PFOS is no longer manufactured in the United States. Similar arrangements have been made for PFOA, and eight companies that manufacture PFOA have committed to eliminate emissions and product content by 2015. Although emissions have been dramatically reduced, the persistence and bioaccumulation of both PFOA and PFOS result in detectable levels in the U.S. population and, therefore, these chemicals are of potential human health relevance. Several recent publications from 2012-2014 have linked PFOA and PFOS exposure to functional immune changes in humans, which are consistent with evidence of PFOA- and PFOS-related immunotoxicity in animal studies.

NTP is conducting a systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity or immune-related health effects. The NTP evaluation concept for immunotoxicity associated with exposure to PFOA or PFOS was initially presented and discussed at the NTP Board of Scientific Counselors (BSC) meeting on December 10, 2014 (79 FR 62640). The NTP evaluation concept, related presentation, and BSC meeting minutes are available at​go/​9741. The protocol for conducting this systematic review is available at​go/​749926.

Request for Information: OHAT invites the public and other interested parties to submit information on PFOA and PFOS including immune-related effects from completed and ongoing epidemiology studies, non-human animal studies, and mechanistic or in vitro studies. This information will be considered in evaluating the potential immune-related health effects of exposure to PFOA and PFOS. Information should be submitted to Dr. Yun Xie (see ADDRESSES).

Request for Nomination of Scientific Experts: OHAT invites nominations of qualified scientists to serve as members of an ad hoc expert panel to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity. Scientists serving on the peer review panel will represent a wide range of expertise including, but not limited to, epidemiology, immunotoxicology, general toxicology, exposure assessment, and biostatistics. Each nomination should include (1) contact information for the nominee (name, affiliation, telephone number, and email), (2) curriculum vitae, and (3) a short description of the individual's expertise such as formal academic training and experience in a relevant scientific field, publications in peer-Start Printed Page 48887reviewed journals, and membership in relevant professional societies. Nominations should be forwarded to Dr. Yun Xie (see ADDRESSES). Final selection of individuals to serve on the peer review panel will be made in accordance with the Federal Advisory Committee Act and Department of Health and Human Services implementing regulations. All panel members serve as individual experts and not as representatives of their employers or other organizations.

Background Information on OHAT: OHAT was established to serve as an environmental health resource to the public and regulatory and health agencies (​pmc/​articles/​PMC3094430). This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as “substances”) cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels. OHAT also organizes workshops or state-of-the-science evaluations to address issues of importance in environmental health sciences. Information about OHAT is found at​go/​ohat.

Start Signature

Dated: August 11, 2015.

John R. Bucher,

Associate Director, National Toxicology Program.

End Signature End Supplemental Information

[FR Doc. 2015-20122 Filed 8-13-15; 8:45 am]