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 Range		33250-33251
FR Document		2016-12361

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

33250 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Notices

respondents into groups that align with ENVIRONMENTAL PROTECTION 2. Electronic Access. You may access
the source categories identified in the AGENCY this Federal Register document
rule. electronically from the Government
[EPA–HQ–OW–2014–0138; FRL–9946–91–
Reporting facilities include, but are OW]
Printing Office under the ‘‘Federal
not limited to, those operating one or Register’’ listings FDSys (http://
more units that exceed the CO2e Lifetime Health Advisories and Health www.gpo.gov/fdsys/browse/
Effects Support Documents for collection.action?collectionCode=FR).
threshold for the industry sectors listed
in Table A–4 of 40 CFR 98.2(a)(2) or Perfluorooctanoic Acid and II. What are perfluorooctanoic acid and
those in the categories in which all must Perfluorooctane Sulfonate perfluorooctane sulfonate and why is
report, such as petroleum refining AGENCY: Environmental Protection EPA concerned about them?
facilities and all other large emitters Agency (EPA).
listed in Table A–3 of 40 CFR 98.2(a)(1). PFOA and PFOS are fluorinated
ACTION: Notice of availability.
Additionally, the GHGRP requires organic chemicals that are part of a
reporting of GHGs from certain SUMMARY: The Environmental Protection larger group of chemicals referred to as
suppliers as listed in Table A–5 of 40 Agency (EPA) announces the release of perfluoroalkyl substances. They were
lifetime health advisories (HAs) and used to make carpets, clothing, fabrics
CFR 98.2(a)(4) and of certain emissions
health effects support documents for for furniture, paper packaging for food
information associated with mobile
Perfluorooctanoic Acid (PFOA) and and other materials (e.g., cookware) that
sources (e.g., for permit applications or
Perfluorooctane Sulfonate (PFOS). EPA are resistant to water, grease or stains.
emissions control certification testing
developed the HAs to assist federal, They are also used for firefighting at
procedures). airfields and in a number of industrial
state, tribal and local officials, and
Respondent’s Obligation To Respond: managers of drinking water systems in processes. Both PFOA and PFOS are
Mandatory (Sections 114 and 208 of the protecting public health when these persistent in the environment and in the
Clean Air Act provide EPA authority to chemicals are present in drinking water. human body. Over time both chemicals
require the information mandated by the EPA’s HAs, which identify the have become widely distributed in the
Greenhouse Gas Reporting Program concentration of PFOA and PFOS in environment and have accumulated in
because such data will inform and are drinking water at or below which the blood of humans, wildlife, and fish.
relevant to future policy decisions). adverse health effects are not Studies indicate that exposure to PFOA
Estimated Number of Respondents: anticipated to occur over a lifetime of and PFOS over certain levels may result
11,080 (total). exposure, are: 0.07 parts per billion (70 in adverse health effects, including
parts per trillion) for PFOA and PFOS. developmental effects to fetuses during
Frequency of Response: Annual. HAs are non-regulatory and reflect pregnancy or to breast-fed infants (e.g.,
Total Estimated Burden: 739,187 EPA’s assessment of the best available low birth weight, accelerated puberty,
hours (per year). Burden is defined at 5 peer-reviewed science. These HAs skeletal variations), cancer (e.g.,
CFR 1320.03(b). supersede EPA’s 2009 provisional HAs testicular, kidney), liver effects (e.g.,
Total Estimated Cost: $99,831,931 per for PFOA and PFOS. tissue damage), immune effects (e.g.,
year, which includes $30,621,791 for FOR FURTHER INFORMATION CONTACT: antibody production and immunity),
Jamie Strong, Health and Ecological and other effects (e.g., cholesterol
capital investment and operation and
Criteria Division, Office of Water (Mail changes).
maintenance costs for respondents,
Code 4304T), Environmental Protection
labor cost of $57,210,010 for III. What are health advisories?
Agency, 1200 Pennsylvania Avenue
respondents, and $12,000,130 for the
NW., Washington, DC 20460; telephone Under the Safe Drinking Water Act,
EPA.
number: (202) 566–0056; email address: EPA may publish HAs for contaminants
Changes in the Estimates: This change strong.jamie@epa.gov. that are not subject to any national
in burden reflects an update in the SUPPLEMENTARY INFORMATION: primary drinking water regulation.
number of respondents, an adjustment SDWA section 1412(b)(1)(F). EPA
of labor rates to 2014 Bureau of Labor I. General Information
develops HAs to provide information on
and Statistics (BLS) labor rates, an A. How can I get copies of this the chemical and physical properties,
adjustment of capital costs to reflect document and other related occurrence and exposure, health effects,
2013 dollars, a re-evaluation of the costs information? quantification of toxicological effects,
to monitor and report combustion 1. Docket. EPA has established a other regulatory standards, analytical
emissions across the entire program, a docket for this action under Docket ID methods, and treatment technology for
re-evaluation of the activities and costs No. EPA–HQ–OW–2014–0138. Publicly drinking water contaminants. HAs
associated with Petroleum and Natural available docket materials are available describe concentrations of drinking
Gas Systems (Subpart W) and Geologic either electronically through water contaminants at which adverse
Sequestration of Carbon Dioxide www.regulations.gov or in hard copy at health effects are not anticipated to
(Subpart RR), and the addition of new the Water Docket in the EPA Docket occur over specific exposure durations
segments and new reporters under Center, (EPA/DC) EPA West, Room (e.g., one-day, ten-days, and a lifetime).
Subpart W. 3334, 1301 Constitution Ave. NW., HAs serve as informal technical
Washington, DC. The EPA Docket guidance to assist federal, state and
mstockstill on DSK3G9T082PROD with NOTICES

Courtney Kerwin, local officials, as well as managers of
Center Public Reading Room is open
Acting Director, Collection Strategies from 8:30 a.m. to 4:30 p.m., Monday public or community water systems in
Division. through Friday, excluding legal protecting public health. They are not
[FR Doc. 2016–12310 Filed 5–24–16; 8:45 am] holidays. The telephone number for the regulations and should not be construed
BILLING CODE 6560–50–P Public Reading Room is (202) 566–1744, as legally enforceable federal standards.
and the telephone number for the Water HAs may change as new information
Docket is (202) 566–2426. becomes available.

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Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Notices 33251

IV. Information on the Drinking Water http://www.regulations.gov under the number: (703) 305–7090; email address:
Health Advisories for PFOA and PFOS docket EPA–HQ–OW–2014–0138. BPPDFRNotices@epa.gov.
Dated: May 19, 2016. SUPPLEMENTARY INFORMATION:
EPA’s HA levels, which identify the
concentration of PFOA and PFOS in Joel Beauvais, I. General Information
drinking water at or below which Deputy Assistant Administrator, Office of
Water. A. Does this action apply to me?
adverse health effects are not
anticipated to occur over a lifetime of [FR Doc. 2016–12361 Filed 5–24–16; 8:45 am] You may be potentially affected by
exposure, are: 0.07 parts per billion (70 BILLING CODE 6560–50–P this action if you are an agricultural
parts per trillion) for PFOA and PFOS. producer, food manufacturer, or
Because these two chemicals cause pesticide manufacturer. The following
similar types of adverse health effects, ENVIRONMENTAL PROTECTION list of North American Industrial
EPA recommends that when both PFOA AGENCY Classification System (NAICS) codes is
and PFOS are found in drinking water not intended to be exhaustive, but rather
the combined concentrations of PFOA [EPA–HQ–OPP–2015–0021; FRL–9946–40] provides a guide to help readers
and PFOS be compared with the 0.07 determine whether this document
Pesticide Product Registration;
part per billion HA level. applies to them. Potentially affected
Receipt of Applications for New Active
EPA’s lifetime HAs are based on peer- entities may include:
Ingredients
reviewed toxicological studies of • Crop production (NAICS code 111).
exposure of animals to PFOA and PFOS, AGENCY: Environmental Protection • Animal production (NAICS code
applying scientifically appropriate Agency (EPA). 112).
uncertainty factors. The development of ACTION: Notice. • Food manufacturing (NAICS code
the HAs was also informed by 311).
SUMMARY: EPA has received applications • Pesticide manufacturing (NAICS
epidemiological studies of human
populations that have been exposed to to register pesticide products containing code 32532).
PFOA and PFOS. The HAs are set at active ingredients not included in any B. What should I consider as I prepare
levels that EPA concluded will not currently registered pesticide products. my comments for EPA?
result in adverse developmental effects Pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act 1. Submitting CBI. Do not submit this
to fetuses during pregnancy or to breast-
fed infants, who are the groups most (FIFRA), EPA is hereby providing notice information to EPA through
of receipt and opportunity to comment regulations.gov or email. Clearly mark
sensitive to the potential harmful effects the part or all of the information that
of PFOA and PFOS. EPA’s analysis on these applications.
DATES: Comments must be received on
you claim to be CBI. For CBI
indicates that exposure to these same information in a disk or CD–ROM that
levels will not result in adverse health or before June 24, 2016.
you mail to EPA, mark the outside of the
effects (including cancer and non- ADDRESSES: Submit your comments, disk or CD–ROM as CBI and then
cancer) to the general population over a identified by docket identification (ID) identify electronically within the disk or
lifetime (or any shorter period) of number and the File Symbol of interest CD–ROM the specific information that
exposure to these chemicals. as shown in the body of this document, is claimed as CBI. In addition to one
EPA’s HAs for PFOA and PFOS are by one of the following methods: complete version of the comment that
supported by peer-reviewed health • Federal eRulemaking Portal: http:// includes information claimed as CBI, a
effects support documents that www.regulations.gov. Follow the online copy of the comment that does not
summarize and analyze available peer- instructions for submitting comments. contain the information claimed as CBI
reviewed studies on toxicokinetics, Do not submit electronically any must be submitted for inclusion in the
human epidemiology, animal toxicity, information you consider to be public docket. Information so marked
and provide a cancer classification and Confidential Business Information (CBI) will not be disclosed except in
a dose response assessment for or other information whose disclosure is accordance with procedures set forth in
noncancer effects. On February 28, restricted by statute. 40 CFR part 2.
2014, EPA released draft versions of • Mail: OPP Docket, Environmental 2. Tips for preparing your comments.
these health effects support documents Protection Agency Docket Center (EPA/ When preparing and submitting your
for a 60-day public comment period and DC), (28221T), 1200 Pennsylvania Ave. comments, see the commenting tips at
initiated a contractor-led, independent NW., Washington, DC 20460–0001. http://www.epa.gov/dockets/
public panel peer review process (79 FR • Hand Delivery: To make special comments.html.
11429). The peer review panel meeting arrangements for hand delivery or
occurred on August 21–22, 2014, and delivery of boxed information, please II. Registration Applications
included seven experts in the following follow the instructions at http:// EPA has received applications to
areas: Epidemiology, toxicology (liver, www.epa.gov/dockets/contacts.html. register pesticide products containing
immune, neurological and reproductive Additional instructions on active ingredients not included in any
and developmental effects), membrane commenting or visiting the docket, currently registered pesticide products.
transport, risk assessment, along with more information about Pursuant to the provisions of FIFRA
pharmacokinetic models, and mode-of- dockets generally, is available at http:// section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
action for cancer and noncancer effects www.epa.gov/dockets. is hereby providing notice of receipt and
mstockstill on DSK3G9T082PROD with NOTICES

(79 FR 39386). Comments submitted to FOR FURTHER INFORMATION CONTACT: opportunity to comment on these
EPA’s public docket during the 60-day Robert McNally, Biopesticides and applications. Notice of receipt of these
public comment period were provided Pollution Prevention Division (7511P), applications does not imply a decision
to the peer reviewers ahead of the Office of Pesticide Programs, by the Agency on these applications.
meeting for their consideration. A peer Environmental Protection Agency, 1200 1. File Symbol: 91197–E. Docket ID
review summary report and other Pennsylvania Ave. NW., Washington, number: EPA–HQ–OPP–2016–0251.
supporting documents may be found at: DC 20460–0001; main telephone Applicant: AFS009 Plant Protection,

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Document Created: 2018-02-07 15:03:34
Document Modified: 2018-02-07 15:03:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Contact		Jamie Strong, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
FR Citation		81 FR 33250