[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48886-48887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20122]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

SUMMARY: 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.

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

ADDRESSES: Information can be submitted to [email protected].

FOR FURTHER INFORMATION CONTACT: 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: [email protected]. Hand Delivery/
Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560.

SUPPLEMENTARY 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 http://ntp.niehs.nih.gov/go/9741. The protocol for conducting this systematic 
review is available at http://ntp.niehs.nih.gov/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-

[[Page 48887]]

reviewed 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 (http://www.ncbi.nlm.nih.gov/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 
http://ntp.niehs.nih.gov/go/ohat.

    Dated: August 11, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-20122 Filed 8-13-15; 8:45 am]
 BILLING CODE 4140-01-P