81 FR 33250 - Lifetime Health Advisories and Health Effects Support Documents for Perfluorooctanoic Acid and Perfluorooctane Sulfonate

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 101 (May 25, 2016)

Page Range33250-33251
FR Document2016-12361

The Environmental Protection Agency (EPA) announces the release of lifetime health advisories (HAs) and health effects support documents for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS). EPA developed the HAs to assist federal, state, tribal and local officials, and managers of drinking water systems in protecting public health when these chemicals are present in drinking water. EPA's HAs, which identify the concentration of PFOA and PFOS in drinking water at or below which adverse health effects are not anticipated to occur over a lifetime of exposure, are: 0.07 parts per billion (70 parts per trillion) for PFOA and PFOS. HAs are non- regulatory and reflect EPA's assessment of the best available peer- reviewed science. These HAs supersede EPA's 2009 provisional HAs for PFOA and PFOS.

Federal Register, Volume 81 Issue 101 (Wednesday, May 25, 2016)
[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Notices]
[Pages 33250-33251]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12361]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2014-0138; FRL-9946-91-OW]


Lifetime Health Advisories and Health Effects Support Documents 
for Perfluorooctanoic Acid and Perfluorooctane Sulfonate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Environmental Protection Agency (EPA) announces the 
release of lifetime health advisories (HAs) and health effects support 
documents for Perfluorooctanoic Acid (PFOA) and Perfluorooctane 
Sulfonate (PFOS). EPA developed the HAs to assist federal, state, 
tribal and local officials, and managers of drinking water systems in 
protecting public health when these chemicals are present in drinking 
water. EPA's HAs, which identify the concentration of PFOA and PFOS in 
drinking water at or below which adverse health effects are not 
anticipated to occur over a lifetime of exposure, are: 0.07 parts per 
billion (70 parts per trillion) for PFOA and PFOS. HAs are non-
regulatory and reflect EPA's assessment of the best available peer-
reviewed science. These HAs supersede EPA's 2009 provisional HAs for 
PFOA and PFOS.

FOR FURTHER INFORMATION CONTACT: Jamie Strong, Health and Ecological 
Criteria Division, Office of Water (Mail Code 4304T), Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; 
telephone number: (202) 566-0056; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. How can I get copies of this document and other related information?

    1. Docket. EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OW-2014-0138. Publicly available docket materials 
are available either electronically through www.regulations.gov or in 
hard copy at the Water Docket in the EPA Docket Center, (EPA/DC) EPA 
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA 
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the Public Reading Room is (202) 566-1744, and the telephone number 
for the Water Docket is (202) 566-2426.
    2. Electronic Access. You may access this Federal Register document 
electronically from the Government Printing Office under the ``Federal 
Register'' listings FDSys (http://www.thefederalregister.org/fdsys/browse/collection.action?collectionCode=FR).

II. What are perfluorooctanoic acid and perfluorooctane sulfonate and 
why is EPA concerned about them?

    PFOA and PFOS are fluorinated organic chemicals that are part of a 
larger group of chemicals referred to as perfluoroalkyl substances. 
They were used to make carpets, clothing, fabrics for furniture, paper 
packaging for food and other materials (e.g., cookware) that are 
resistant to water, grease or stains. They are also used for 
firefighting at airfields and in a number of industrial processes. Both 
PFOA and PFOS are persistent in the environment and in the human body. 
Over time both chemicals have become widely distributed in the 
environment and have accumulated in the blood of humans, wildlife, and 
fish. Studies indicate that exposure to PFOA and PFOS over certain 
levels may result in adverse health effects, including developmental 
effects to fetuses during pregnancy or to breast-fed infants (e.g., low 
birth weight, accelerated puberty, skeletal variations), cancer (e.g., 
testicular, kidney), liver effects (e.g., tissue damage), immune 
effects (e.g., antibody production and immunity), and other effects 
(e.g., cholesterol changes).

III. What are health advisories?

    Under the Safe Drinking Water Act, EPA may publish HAs for 
contaminants that are not subject to any national primary drinking 
water regulation. SDWA section 1412(b)(1)(F). EPA develops HAs to 
provide information on the chemical and physical properties, occurrence 
and exposure, health effects, quantification of toxicological effects, 
other regulatory standards, analytical methods, and treatment 
technology for drinking water contaminants. HAs describe concentrations 
of drinking water contaminants at which adverse health effects are not 
anticipated to occur over specific exposure durations (e.g., one-day, 
ten-days, and a lifetime). HAs serve as informal technical guidance to 
assist federal, state and local officials, as well as managers of 
public or community water systems in protecting public health. They are 
not regulations and should not be construed as legally enforceable 
federal standards. HAs may change as new information becomes available.

[[Page 33251]]

IV. Information on the Drinking Water Health Advisories for PFOA and 
PFOS

    EPA's HA levels, which identify the concentration of PFOA and PFOS 
in drinking water at or below which adverse health effects are not 
anticipated to occur over a lifetime of exposure, are: 0.07 parts per 
billion (70 parts per trillion) for PFOA and PFOS. Because these two 
chemicals cause similar types of adverse health effects, EPA recommends 
that when both PFOA and PFOS are found in drinking water the combined 
concentrations of PFOA and PFOS be compared with the 0.07 part per 
billion HA level.
    EPA's lifetime HAs are based on peer-reviewed toxicological studies 
of exposure of animals to PFOA and PFOS, applying scientifically 
appropriate uncertainty factors. The development of the HAs was also 
informed by epidemiological studies of human populations that have been 
exposed to PFOA and PFOS. The HAs are set at levels that EPA concluded 
will not result in adverse developmental effects to fetuses during 
pregnancy or to breast-fed infants, who are the groups most sensitive 
to the potential harmful effects of PFOA and PFOS. EPA's analysis 
indicates that exposure to these same levels will not result in adverse 
health effects (including cancer and non-cancer) to the general 
population over a lifetime (or any shorter period) of exposure to these 
chemicals.
    EPA's HAs for PFOA and PFOS are supported by peer-reviewed health 
effects support documents that summarize and analyze available peer-
reviewed studies on toxicokinetics, human epidemiology, animal 
toxicity, and provide a cancer classification and a dose response 
assessment for noncancer effects. On February 28, 2014, EPA released 
draft versions of these health effects support documents for a 60-day 
public comment period and initiated a contractor-led, independent 
public panel peer review process (79 FR 11429). The peer review panel 
meeting occurred on August 21-22, 2014, and included seven experts in 
the following areas: Epidemiology, toxicology (liver, immune, 
neurological and reproductive and developmental effects), membrane 
transport, risk assessment, pharmacokinetic models, and mode-of-action 
for cancer and noncancer effects (79 FR 39386). Comments submitted to 
EPA's public docket during the 60-day public comment period were 
provided to the peer reviewers ahead of the meeting for their 
consideration. A peer review summary report and other supporting 
documents may be found at: http://www.regulations.gov under the docket 
EPA-HQ-OW-2014-0138.

    Dated: May 19, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-12361 Filed 5-24-16; 8:45 am]
 BILLING CODE 6560-50-P


81_FR_33351
Current View
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
ContactJamie Strong, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
FR Citation81 FR 33250 

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