Lifetime Health Advisories and Health Effects Support Documents for Perfluorooctanoic Acid and Perfluorooctane Sulfonate, 33250-33251 [2016-12361]

Download as PDF 33250 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES respondents into groups that align with the source categories identified in the rule. Reporting facilities include, but are not limited to, those operating one or more units that exceed the CO2e threshold for the industry sectors listed in Table A–4 of 40 CFR 98.2(a)(2) or those in the categories in which all must report, such as petroleum refining facilities and all other large emitters listed in Table A–3 of 40 CFR 98.2(a)(1). Additionally, the GHGRP requires reporting of GHGs from certain suppliers as listed in Table A–5 of 40 CFR 98.2(a)(4) and of certain emissions information associated with mobile sources (e.g., for permit applications or emissions control certification testing procedures). Respondent’s Obligation To Respond: Mandatory (Sections 114 and 208 of the Clean Air Act provide EPA authority to require the information mandated by the Greenhouse Gas Reporting Program because such data will inform and are relevant to future policy decisions). Estimated Number of Respondents: 11,080 (total). Frequency of Response: Annual. Total Estimated Burden: 739,187 hours (per year). Burden is defined at 5 CFR 1320.03(b). Total Estimated Cost: $99,831,931 per year, which includes $30,621,791 for capital investment and operation and maintenance costs for respondents, labor cost of $57,210,010 for respondents, and $12,000,130 for the EPA. Changes in the Estimates: This change in burden reflects an update in the number of respondents, an adjustment of labor rates to 2014 Bureau of Labor and Statistics (BLS) labor rates, an adjustment of capital costs to reflect 2013 dollars, a re-evaluation of the costs to monitor and report combustion emissions across the entire program, a re-evaluation of the activities and costs associated with Petroleum and Natural Gas Systems (Subpart W) and Geologic Sequestration of Carbon Dioxide (Subpart RR), and the addition of new segments and new reporters under Subpart W. Courtney Kerwin, Acting Director, Collection Strategies Division. [FR Doc. 2016–12310 Filed 5–24–16; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 20:19 May 24, 2016 Jkt 238001 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 Environmental Protection Agency (EPA). ACTION: Notice of availability. AGENCY: 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: strong.jamie@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: 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. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 2. Electronic Access. You may access this Federal Register document electronically from the Government Printing Office under the ‘‘Federal Register’’ listings FDSys (https:// www.gpo.gov/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. E:\FR\FM\25MYN1.SGM 25MYN1 Federal Register / Vol. 81, No. 101 / Wednesday, May 25, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES IV. Information on the Drinking Water Health Advisories for PFOA and PFOS https://www.regulations.gov under the docket EPA–HQ–OW–2014–0138. 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 peerreviewed 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 breastfed 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 noncancer) 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 peerreviewed 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-ofaction 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: Dated: May 19, 2016. Joel Beauvais, Deputy Assistant Administrator, Office of Water. VerDate Sep<11>2014 20:19 May 24, 2016 Jkt 238001 33251 number: (703) 305–7090; email address: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following ENVIRONMENTAL PROTECTION list of North American Industrial AGENCY Classification System (NAICS) codes is not intended to be exhaustive, but rather [EPA–HQ–OPP–2015–0021; FRL–9946–40] provides a guide to help readers determine whether this document Pesticide Product Registration; applies to them. Potentially affected Receipt of Applications for New Active entities may include: Ingredients • Crop production (NAICS code 111). • Animal production (NAICS code AGENCY: Environmental Protection 112). Agency (EPA). • Food manufacturing (NAICS code ACTION: Notice. 311). • Pesticide manufacturing (NAICS SUMMARY: EPA has received applications to register pesticide products containing code 32532). active ingredients not included in any B. What should I consider as I prepare currently registered pesticide products. my comments for EPA? Pursuant to the Federal Insecticide, 1. Submitting CBI. Do not submit this Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice information to EPA through regulations.gov or email. Clearly mark of receipt and opportunity to comment the part or all of the information that on these applications. you claim to be CBI. For CBI DATES: Comments must be received on information in a disk or CD–ROM that or before June 24, 2016. you mail to EPA, mark the outside of the ADDRESSES: Submit your comments, disk or CD–ROM as CBI and then identified by docket identification (ID) identify electronically within the disk or number and the File Symbol of interest CD–ROM the specific information that as shown in the body of this document, is claimed as CBI. In addition to one by one of the following methods: complete version of the comment that • Federal eRulemaking Portal: https:// includes information claimed as CBI, a www.regulations.gov. Follow the online copy of the comment that does not instructions for submitting comments. contain the information claimed as CBI Do not submit electronically any must be submitted for inclusion in the information you consider to be public docket. Information so marked Confidential Business Information (CBI) will not be disclosed except in or other information whose disclosure is accordance with procedures set forth in restricted by statute. 40 CFR part 2. • Mail: OPP Docket, Environmental 2. Tips for preparing your comments. Protection Agency Docket Center (EPA/ When preparing and submitting your DC), (28221T), 1200 Pennsylvania Ave. comments, see the commenting tips at NW., Washington, DC 20460–0001. https://www.epa.gov/dockets/ • Hand Delivery: To make special comments.html. arrangements for hand delivery or II. Registration Applications delivery of boxed information, please follow the instructions at https:// EPA has received applications to www.epa.gov/dockets/contacts.html. register pesticide products containing Additional instructions on active ingredients not included in any commenting or visiting the docket, currently registered pesticide products. along with more information about Pursuant to the provisions of FIFRA dockets generally, is available at https:// section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA www.epa.gov/dockets. is hereby providing notice of receipt and FOR FURTHER INFORMATION CONTACT: opportunity to comment on these Robert McNally, Biopesticides and applications. Notice of receipt of these Pollution Prevention Division (7511P), applications does not imply a decision Office of Pesticide Programs, by the Agency on these applications. 1. File Symbol: 91197–E. Docket ID Environmental Protection Agency, 1200 number: EPA–HQ–OPP–2016–0251. Pennsylvania Ave. NW., Washington, Applicant: AFS009 Plant Protection, DC 20460–0001; main telephone [FR Doc. 2016–12361 Filed 5–24–16; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1

Agencies

[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Notices]
[Pages 33250-33251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12361]


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

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.

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

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: strong.jamie@epa.gov.

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 (https://www.gpo.gov/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: https://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
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