Request for Public Review and Comment: Draft Human Health Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane Sulfonate, 58768-58770 [2018-25422]
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58768
Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
or in person at the EPA Docket Center,
WJC West, Room 3334, 1301
Constitution Ave. NW, Washington, DC.
The telephone number for the Docket
Center is 202–566–1744. For additional
information about the EPA’s public
docket, visit https://www.epa.gov/
dockets.
Pursuant to section 3506(c)(2)(A) of
the PRA, the EPA is soliciting comments
and information to enable it to: (i)
Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Agency, including
whether the information will have
practical utility; (ii) evaluate the
accuracy of the Agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(iii) enhance the quality, utility, and
clarity of the information to be
collected; and (iv) minimize the burden
of the collection of information on those
who are to respond, including through
the use of appropriate automated
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses. The EPA will consider the
comments received and amend the ICR
as appropriate. The final ICR package
will then be submitted to OMB for
review and approval. At that time, the
EPA will issue another Federal Register
notice to announce the submission of
the ICR to OMB and the opportunity to
submit additional comments to OMB.
Abstract: The Beaches Environmental
Assessment and Coastal Health
(BEACH) Act amends the Clean Water
Act (CWA) in part and authorizes the
U.S. Environmental Protection Agency
(EPA) to award BEACH Act Program
Development and Implementation
Grants to coastal and Great Lakes states,
tribes, and territories (collectively
referred to as jurisdictions) for their
beach monitoring and notification
programs. The grants assist those
jurisdictions to develop and implement
a consistent approach to monitor
recreational water quality; assess,
manage, and communicate health risks
from waterborne microbial
contamination; notify the public of
pollution occurrences, and post beach
advisories and closures to prevent
public exposure to microbial pathogens.
To qualify for a BEACH Act Grant, a
jurisdiction must submit information to
the EPA documenting that its beach
monitoring and notification program is
consistent with performance criteria
outlined in the National Beach
Guidance and Required Performance
Criteria for Grants, 2014 Edition.
VerDate Sep<11>2014
16:08 Nov 20, 2018
Jkt 247001
Form numbers: None.
Respondents/affected entities: Entities
potentially affected by this action are
environmental and public health
agencies in coastal and Great Lakes
states, territories, and tribes.
Respondent’s obligation to respond:
Required to obtain the grants as directed
by the BEACH Act amendment to the
CWA.
Estimated number of respondents: 39.
Frequency of response: Annual;
however, the agency encourages more
frequent reporting to provide more upto-date information to the public.
Total estimated burden: 88,569 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $14,865,812 (per
year), includes $11,063,780 (per year)
operation & maintenance costs. There
are no capital costs.
Changes in estimates: There is a
decrease of 2,707 hours in the total
respondent burden compared with the
ICR approved by OMB in July 2015 due
to the respondents no longer needing to
prepare and submit schedules for the
adoption of new or revised WQS and
identification and use of a beach
notification threshold (BNT). The EPA
no longer requests respondents submit
these schedules because they are using
BNTs or alternate BNTs and have either
adopted new or revised WQS or are in
the process of doing so. This decrease in
hours is partially offset by one
additional tribe having qualified for a
BEACH grant. The total respondent cost
decreased by $587,496. The decrease in
cost is partially offset by slight increases
in the salary rates. The O&M decreased
by $289,366 due to a reduction in the
total number of beaches (affecting
O&M). The number of beaches reported
by the jurisdictions varies from year to
year for many reasons. Reasons for
removing beaches include the
destruction of beaches by natural
disasters, change in beach ownership,
and existing beaches being combined
within a jurisdiction’s monitoring and
notification program.
Dated: November 13, 2018.
Deborah G. Nagle,
Acting Director, Office of Science and
Technology.
[FR Doc. 2018–25423 Filed 11–20–18; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OW–2018–0614; FRL–9986–79–
OW]
Request for Public Review and
Comment: Draft Human Health Toxicity
Assessments for Hexafluoropropylene
Oxide Dimer Acid and Its Ammonium
Salt (GenX Chemicals) and for
Perfluorobutane Sulfonic Acid (PFBS)
and Related Compound Potassium
Perfluorobutane Sulfonate
Environmental Protection
Agency (EPA).
ACTION: Notice of public comment
period.
AGENCY:
The Environmental Protection
Agency (EPA) is announcing a 60-day
public comment period associated with
the release of two draft toxicity
assessments for public comment:
• Draft Human Health Toxicity
Values for Hexafluoropropylene Oxide
(HFPO) Dimer Acid and its Ammonium
Salt (GenX Chemicals).
• Draft Human Health Toxicity
Values for Perfluorobutane Sulfonic
Acid (PFBS) and Related Compound
Potassium Perfluorobutane Sulfonate.
The EPA developed the draft
assessments to provide the health effects
information available for GenX
chemicals and PFBS and describe how
that information was used to derive
draft toxicity values. These draft toxicity
assessments underwent independent,
external expert peer review in June-July
2018. Following closure of this 60-day
public comment period, the EPA will
consider the comments, revise the draft
documents, and consider the need for
additional peer review, as appropriate,
and then publish final toxicity
assessments. The toxicity assessments
for GenX chemicals and PFBS are
scientific and technical reports that
include toxicity values associated with
potential noncancer health effects
following oral exposure (in this case,
oral reference doses [RfDs]). These
assessments evaluate human health
hazards. The toxicity assessments and
the values contained within are not risk
assessments as they do not include
exposure assessments or provide a risk
characterization. Further, the toxicity
assessments do not address the legal,
political, social, economic, or technical
considerations involved in risk
management. When issued, the toxicity
assessments can be used by the EPA,
states, tribes, and local communities,
along with specific exposure and other
relevant information, to determine,
under the appropriate regulations and
statutes, if and when it is necessary to
SUMMARY:
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Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
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take action to address potential risk
associated with human exposures to
these per- and polyfluoroalkyl
substances (PFAS) chemicals.
DATES: Comments must be received on
or before January 22, 2019.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OW–2018–0614, to the public docket at:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Once submitted, comments
cannot be edited or withdrawn. The
EPA may publish any comment received
to its public docket. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the web,
cloud, or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
For information on the docket,
contact the docket manager: Assem
Akram, Docket Manager, EPA Docket
Center, telephone: (202) 566–0226; or
email: Akram.Assem@epa.gov.
For technical information on GenX
chemicals: Dr. Jamie Strong, Health and
Ecological Criteria Division, Office of
Water (Mail Code 4304T),
Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington,
DC 20460; telephone: (202) 566–0056; or
email: strong.jamie@epa.gov.
For technical information on PFBS:
Dr. Samantha Jones, National Center for
Environmental Assessment, Office of
Research and Development (Mail Code
8602R), Environmental Protection
Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone:
202–564–6794; or email:
jones.samantha@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
Supporting documents are available
in the public docket for this ICR (under
Docket ID number EPA–HQ–OW–2018–
0614. The docket can be viewed online
at https://www.regulations.gov or in
person at the EPA Docket Center, WJC
VerDate Sep<11>2014
16:08 Nov 20, 2018
Jkt 247001
West, Room 3334, 1301 Constitution
Ave. NW, Washington, DC. The
telephone number for the Docket Center
is 202–566–1744. For additional
information about the EPA’s public
docket, visit https://www.epa.gov/
dockets.
A. Does this action apply to me?
This request for public comment will
not impose any requirements on
anyone. Instead, this action notifies
interested parties of the availability of
draft toxicity assessments for GenX
Chemicals and PFBS for public
comment. It should be noted that when
final these toxicity assessments may be
used by the EPA, states, tribes, and local
communities, along with specific
exposure and other relevant
information, to determine, under the
appropriate regulations and statutes, if
and when it is necessary to take action
to address potential risk associated with
human exposures to these PFAS
chemicals.
B. What should I consider as I prepare
my comments for the EPA?
1. Submit your comments, identified
by Docket ID No. EPA–HQ–OW–2018–
0614, at https://www.regulations.gov
(our preferred method), or the other
methods identified in the ADDRESSES
section. Once submitted, comments
cannot be edited or removed from the
docket. The EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Clearly mark the
part or all of the information that you
claim to be CBI. For CBI information in
a disk or CD–ROM that you mail to the
EPA, mark the outside of the disk or
CD–ROM as CBI and then identify
electronically within the disk or CD–
ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
the Code of Federal Regulations (CFR) at
40 CFR part 2. Multimedia submissions
(audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
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58769
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
II. What are GenX chemicals and
PFBS?
GenX chemicals and PFBS are manmade, fluorinated organic chemicals
that are part of a larger group of
manmade chemicals referred to as perand polyfluoroalkyl substances (PFAS).
PFAS are used in many applications
because of their unique physical
properties such as resistance to high and
low temperatures, resistance to
degradation, and nonstick
characteristics. GenX is a trade name for
a processing aid technology used to
make high-performance fluoropolymers
without the use of perfluorooctanoic
acid (PFOA). Hexafluoropropylene
oxide (HFPO) dimer acid and its
ammonium salt are the major chemicals
associated with the GenX processing aid
technology and the focus of the draft
assessment. PFBS is a four-carbon PFAS
that was developed as a replacement for
longer-chain PFAS, which have
demonstrated environmental
persistence, long half-lives and
bioaccumulation in humans. PFBS has
been integrated into various consumer
products and applications.
III. What are EPA’s draft toxicity
assessments?
The EPA’s draft toxicity assessments
for GenX Chemicals and PFBS provide
information on hazard identification
and dose-response, including draft
subchronic and chronic oral reference
doses (RfDs) for each chemical. Overall,
the available oral toxicity studies
demonstrate that the liver is particularly
sensitive to GenX chemicals, and the
thyroid and kidney are sensitive to
PFBS. The draft toxicity assessments
underwent independent, external peer
review in June and July 2018 and were
revised accordingly.
In the risk assessment/risk
management paradigm, a toxicity
assessment is on the risk assessment
side of the paradigm. The draft toxicity
assessments for GenX chemicals and
PFBS address the first two steps (Step
1. Hazard Identification and Step 2.
Dose-Response) of the four-step risk
assessment process described by the
National Academy of Science in 1983 as
‘‘the characterization of the potential
adverse health effects of human
exposures to environmental hazards.’’
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Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
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Characterizing risk involves integrating
information on hazard, dose-response,
and exposure. For further details about
risk assessments see: https://
www.epa.gov/risk/conducting-humanhealth-risk-assessment.
When issued, the toxicity values for
GenX chemicals and PFBS can be
combined with specific exposure
information (Step 3. Exposure
Assessment) by government and private
entities to help characterize (Step 4.
Risk Characterization) potential public
health risks associated with exposure to
these chemicals. Thus, once the GenX
chemicals and PFBS assessments are
issued, the EPA will work with our
state, tribal, and local partners to
provide technical assistance, including
information about appropriate
regulations and statutes, as they begin
considering the final values in relevant
exposure scenarios. It is the risk
management part of the risk assessment/
risk management paradigm where the
supporting science, as well as statutory
and legal considerations, risk
management options, public health
considerations, cost/benefit
considerations, economic factors, social
factors, and other considerations are
weighed.
The EPA recognizes that humans have
the potential to be exposed to complex
mixtures of PFAS and other chemicals
and pathogens through drinking water
and other exposure sources. The EPA’s
draft assessments for GenX chemicals
and PFBS focus solely on the potential
human health effects associated with
oral exposure to each chemical; they do
not consider potential cumulative
(mixture) effects of GenX chemicals and
PFBS or their possible interactions with
other PFAS and/or other chemicals.
This would involve a more complex
assessment that would need to consider
and evaluate mechanisms of action and
endpoints of concern for each of the
chemicals in the mixture.
IV. Why is the EPA releasing draft
toxicity assessments for these
chemicals?
The EPA is issuing the draft toxicity
assessments for PFBS and GenX
chemicals for public comment to give
interested stakeholders and the public
an opportunity to provide input to the
Agency. The public will have 60 days
after publication in the Federal Register
to provide input. At the end of the
comment period, the EPA will evaluate
the input, make appropriate revisions,
and finalize the toxicity assessments.
Once the toxicity assessments are
issued, the EPA will work with our
state, tribal, and local partners to
provide technical assistance, as they
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16:08 Nov 20, 2018
Jkt 247001
begin using the final values in relevant
exposure scenarios to generate risk
assessments to support risk management
decisions.
Dated: November 14, 2018.
David P. Ross,
Assistant Administrator, Office of Water.
V. Solicitation of Public Comment
BILLING CODE 6560–50–P
During the 60-day comment period,
the EPA is soliciting public comments
regarding the science and technical
approaches used in the derivation of the
draft toxicity assessments for GenX
chemicals and PFBS.
In the PFBS assessment, due to the
lack of epidemiological studies
demonstrating adverse effects in
humans, the EPA derived candidate
subchronic RfDs (see Section 6.1.1 of
the toxicity assessment) and candidate
chronic RfDs (see Section 6.1.2 of the
toxicity assessment) for both thyroid
effects and kidney effects in rodent
toxicity studies. In light of the
consistent observation of the thyroid
effects across life stages and the greater
dose-response sensitivity, relative to the
kidney effects, the EPA is proposing to
base the overall subchronic and chronic
RfDs on the thyroid effects and is
requesting public review and comment
on this proposal in addition to the
approaches and conclusions in the
PFBS assessment. Additionally, as
described in Section 6.1 of the PFBS
toxicity assessment, decreased serum
total T4 (thyroxine) in newborn mice
was used as the basis for the thyroidrelated candidate RfDs. Peer reviewers
provided comments on thyroid effects
and this choice of endpoint. See pages
15–25 and 31–32 in the Response to
Peer Review Comments on the Draft
Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN
375–73–5) and Related Compound
Potassium Perfluorobutane Sulfonate
(CASRN 29420–49–3) for the array of
peer review comments on these topics
and the EPA’s responses. These
supporting documents are available in
the public docket for this ICR (under
Docket ID number EPA–HQ–OW–2018–
0614. Comments from the public are
requested on the thyroid effects, this
choice of endpoint, as well as the
discussion on thyroid hormone
economy in humans and animals (see
Section 6.1 of the PFBS toxicity
assessment).
These draft assessments are not final
as described in the EPA’s information
quality guidelines, and do not represent
Agency policy or views. The EPA will
consider all public comments submitted
in response to this notice when revising
these documents.
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[FR Doc. 2018–25422 Filed 11–20–18; 8:45 am]
FEDERAL DEPOSIT INSURANCE
CORPORATION
FDIC Systemic Resolution Advisory
Committee; Notice of Meeting
Federal Deposit Insurance
Corporation (FDIC).
ACTION: Notice of open meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given of a meeting of the FDIC
Systemic Resolution Advisory
Committee, which will be held in
Washington, DC. The Advisory
Committee will provide advice and
recommendations on a broad range of
policy issues regarding the resolution of
systemically important financial
companies.
DATES: Thursday, December 6, 2018,
from 9:00 a.m. to 4:00 p.m.
ADDRESSES: The meeting will be held in
the FDIC Board Room on the sixth floor
of the FDIC Building located at 550 17th
Street NW, Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Requests for further information
concerning the meeting may be directed
to Mr. Robert E. Feldman, Committee
Management Officer of the FDIC, at
(202) 898–7043.
SUPPLEMENTARY INFORMATION:
Agenda: The agenda will include a
discussion of a range of issues and
developments related to the resolution
of systemically important financial
companies. The agenda may be subject
to change. Any changes to the agenda
will be announced at the beginning of
the meeting.
Type of Meeting: The meeting will be
open to the public, limited only by the
space available on a first-come, firstserved basis. For security reasons,
members of the public will be subject to
security screening procedures and must
present a valid photo identification to
enter the building. The FDIC will
provide attendees with auxiliary aids
(e.g., sign language interpretation)
required for this meeting. Those
attendees needing such assistance
should call (703) 562–6067 (Voice or
TTY) at least two days before the
meeting to make necessary
arrangements. Written statements may
be filed with the committee before or
after the meeting. This meeting of the
FDIC Systemic Resolution Advisory
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58768-58770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25422]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2018-0614; FRL-9986-79-OW]
Request for Public Review and Comment: Draft Human Health
Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and Its
Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid
(PFBS) and Related Compound Potassium Perfluorobutane Sulfonate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-
day public comment period associated with the release of two draft
toxicity assessments for public comment:
Draft Human Health Toxicity Values for Hexafluoropropylene
Oxide (HFPO) Dimer Acid and its Ammonium Salt (GenX Chemicals).
Draft Human Health Toxicity Values for Perfluorobutane
Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane
Sulfonate.
The EPA developed the draft assessments to provide the health
effects information available for GenX chemicals and PFBS and describe
how that information was used to derive draft toxicity values. These
draft toxicity assessments underwent independent, external expert peer
review in June-July 2018. Following closure of this 60-day public
comment period, the EPA will consider the comments, revise the draft
documents, and consider the need for additional peer review, as
appropriate, and then publish final toxicity assessments. The toxicity
assessments for GenX chemicals and PFBS are scientific and technical
reports that include toxicity values associated with potential
noncancer health effects following oral exposure (in this case, oral
reference doses [RfDs]). These assessments evaluate human health
hazards. The toxicity assessments and the values contained within are
not risk assessments as they do not include exposure assessments or
provide a risk characterization. Further, the toxicity assessments do
not address the legal, political, social, economic, or technical
considerations involved in risk management. When issued, the toxicity
assessments can be used by the EPA, states, tribes, and local
communities, along with specific exposure and other relevant
information, to determine, under the appropriate regulations and
statutes, if and when it is necessary to
[[Page 58769]]
take action to address potential risk associated with human exposures
to these per- and polyfluoroalkyl substances (PFAS) chemicals.
DATES: Comments must be received on or before January 22, 2019.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2018-0614, to the public docket at: https://www.regulations.gov. Follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or withdrawn. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
For information on the docket, contact the docket manager: Assem
Akram, Docket Manager, EPA Docket Center, telephone: (202) 566-0226; or
email: [email protected].
For technical information on GenX chemicals: Dr. Jamie Strong,
Health and Ecological Criteria Division, Office of Water (Mail Code
4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460; telephone: (202) 566-0056; or email:
[email protected].
For technical information on PFBS: Dr. Samantha Jones, National
Center for Environmental Assessment, Office of Research and Development
(Mail Code 8602R), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW, Washington, DC 20460; telephone: 202-564-6794; or email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
Supporting documents are available in the public docket for this
ICR (under Docket ID number EPA-HQ-OW-2018-0614. The docket can be
viewed online at https://www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about the EPA's public docket, visit
https://www.epa.gov/dockets.
A. Does this action apply to me?
This request for public comment will not impose any requirements on
anyone. Instead, this action notifies interested parties of the
availability of draft toxicity assessments for GenX Chemicals and PFBS
for public comment. It should be noted that when final these toxicity
assessments may be used by the EPA, states, tribes, and local
communities, along with specific exposure and other relevant
information, to determine, under the appropriate regulations and
statutes, if and when it is necessary to take action to address
potential risk associated with human exposures to these PFAS chemicals.
B. What should I consider as I prepare my comments for the EPA?
1. Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2018-0614, at https://www.regulations.gov (our preferred method), or
the other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to the EPA, mark the outside of the disk or CD-ROM as CBI and then
identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
the Code of Federal Regulations (CFR) at 40 CFR part 2. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
II. What are GenX chemicals and PFBS?
GenX chemicals and PFBS are man-made, fluorinated organic chemicals
that are part of a larger group of manmade chemicals referred to as
per- and polyfluoroalkyl substances (PFAS). PFAS are used in many
applications because of their unique physical properties such as
resistance to high and low temperatures, resistance to degradation, and
nonstick characteristics. GenX is a trade name for a processing aid
technology used to make high-performance fluoropolymers without the use
of perfluorooctanoic acid (PFOA). Hexafluoropropylene oxide (HFPO)
dimer acid and its ammonium salt are the major chemicals associated
with the GenX processing aid technology and the focus of the draft
assessment. PFBS is a four-carbon PFAS that was developed as a
replacement for longer-chain PFAS, which have demonstrated
environmental persistence, long half-lives and bioaccumulation in
humans. PFBS has been integrated into various consumer products and
applications.
III. What are EPA's draft toxicity assessments?
The EPA's draft toxicity assessments for GenX Chemicals and PFBS
provide information on hazard identification and dose-response,
including draft subchronic and chronic oral reference doses (RfDs) for
each chemical. Overall, the available oral toxicity studies demonstrate
that the liver is particularly sensitive to GenX chemicals, and the
thyroid and kidney are sensitive to PFBS. The draft toxicity
assessments underwent independent, external peer review in June and
July 2018 and were revised accordingly.
In the risk assessment/risk management paradigm, a toxicity
assessment is on the risk assessment side of the paradigm. The draft
toxicity assessments for GenX chemicals and PFBS address the first two
steps (Step 1. Hazard Identification and Step 2. Dose-Response) of the
four-step risk assessment process described by the National Academy of
Science in 1983 as ``the characterization of the potential adverse
health effects of human exposures to environmental hazards.''
[[Page 58770]]
Characterizing risk involves integrating information on hazard, dose-
response, and exposure. For further details about risk assessments see:
https://www.epa.gov/risk/conducting-human-health-risk-assessment.
When issued, the toxicity values for GenX chemicals and PFBS can be
combined with specific exposure information (Step 3. Exposure
Assessment) by government and private entities to help characterize
(Step 4. Risk Characterization) potential public health risks
associated with exposure to these chemicals. Thus, once the GenX
chemicals and PFBS assessments are issued, the EPA will work with our
state, tribal, and local partners to provide technical assistance,
including information about appropriate regulations and statutes, as
they begin considering the final values in relevant exposure scenarios.
It is the risk management part of the risk assessment/risk management
paradigm where the supporting science, as well as statutory and legal
considerations, risk management options, public health considerations,
cost/benefit considerations, economic factors, social factors, and
other considerations are weighed.
The EPA recognizes that humans have the potential to be exposed to
complex mixtures of PFAS and other chemicals and pathogens through
drinking water and other exposure sources. The EPA's draft assessments
for GenX chemicals and PFBS focus solely on the potential human health
effects associated with oral exposure to each chemical; they do not
consider potential cumulative (mixture) effects of GenX chemicals and
PFBS or their possible interactions with other PFAS and/or other
chemicals. This would involve a more complex assessment that would need
to consider and evaluate mechanisms of action and endpoints of concern
for each of the chemicals in the mixture.
IV. Why is the EPA releasing draft toxicity assessments for these
chemicals?
The EPA is issuing the draft toxicity assessments for PFBS and GenX
chemicals for public comment to give interested stakeholders and the
public an opportunity to provide input to the Agency. The public will
have 60 days after publication in the Federal Register to provide
input. At the end of the comment period, the EPA will evaluate the
input, make appropriate revisions, and finalize the toxicity
assessments. Once the toxicity assessments are issued, the EPA will
work with our state, tribal, and local partners to provide technical
assistance, as they begin using the final values in relevant exposure
scenarios to generate risk assessments to support risk management
decisions.
V. Solicitation of Public Comment
During the 60-day comment period, the EPA is soliciting public
comments regarding the science and technical approaches used in the
derivation of the draft toxicity assessments for GenX chemicals and
PFBS.
In the PFBS assessment, due to the lack of epidemiological studies
demonstrating adverse effects in humans, the EPA derived candidate
subchronic RfDs (see Section 6.1.1 of the toxicity assessment) and
candidate chronic RfDs (see Section 6.1.2 of the toxicity assessment)
for both thyroid effects and kidney effects in rodent toxicity studies.
In light of the consistent observation of the thyroid effects across
life stages and the greater dose-response sensitivity, relative to the
kidney effects, the EPA is proposing to base the overall subchronic and
chronic RfDs on the thyroid effects and is requesting public review and
comment on this proposal in addition to the approaches and conclusions
in the PFBS assessment. Additionally, as described in Section 6.1 of
the PFBS toxicity assessment, decreased serum total T4 (thyroxine) in
newborn mice was used as the basis for the thyroid-related candidate
RfDs. Peer reviewers provided comments on thyroid effects and this
choice of endpoint. See pages 15-25 and 31-32 in the Response to Peer
Review Comments on the Draft Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound
Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3) for the array of
peer review comments on these topics and the EPA's responses. These
supporting documents are available in the public docket for this ICR
(under Docket ID number EPA-HQ-OW-2018-0614. Comments from the public
are requested on the thyroid effects, this choice of endpoint, as well
as the discussion on thyroid hormone economy in humans and animals (see
Section 6.1 of the PFBS toxicity assessment).
These draft assessments are not final as described in the EPA's
information quality guidelines, and do not represent Agency policy or
views. The EPA will consider all public comments submitted in response
to this notice when revising these documents.
Dated: November 14, 2018.
David P. Ross,
Assistant Administrator, Office of Water.
[FR Doc. 2018-25422 Filed 11-20-18; 8:45 am]
BILLING CODE 6560-50-P
