83 FR 58768 - 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 Federal Register Volume 83, Issue 225 (November 21, 2018)
Federal Register Volume 83, Issue 225 (November 21, 2018)
| Page Range | 58768-58770 | |
| FR Document | 2018-25422 |
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)] [Notices] [Pages 58768-58770] From the Federal Register Online [www.thefederalregister.org] [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: http://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 http://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 http://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 http://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
![58768 Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
or in person at the EPA Docket Center, Form numbers: None. ENVIRONMENTAL PROTECTION
WJC West, Room 3334, 1301 Respondents/affected entities: Entities AGENCY
Constitution Ave. NW, Washington, DC. potentially affected by this action are [EPA–HQ–OW–2018–0614; FRL–9986–79–
The telephone number for the Docket environmental and public health OW]
Center is 202–566–1744. For additional
agencies in coastal and Great Lakes
information about the EPA’s public Request for Public Review and
states, territories, and tribes.
docket, visit http://www.epa.gov/ Comment: Draft Human Health Toxicity
dockets. Respondent’s obligation to respond: Assessments for Hexafluoropropylene
Pursuant to section 3506(c)(2)(A) of Required to obtain the grants as directed Oxide Dimer Acid and Its Ammonium
the PRA, the EPA is soliciting comments by the BEACH Act amendment to the Salt (GenX Chemicals) and for
and information to enable it to: (i) CWA. Perfluorobutane Sulfonic Acid (PFBS)
Evaluate whether the proposed Estimated number of respondents: 39. and Related Compound Potassium
collection of information is necessary Perfluorobutane Sulfonate
for the proper performance of the Frequency of response: Annual;
functions of the Agency, including however, the agency encourages more AGENCY: Environmental Protection
whether the information will have frequent reporting to provide more up- Agency (EPA).
practical utility; (ii) evaluate the to-date information to the public. ACTION: Notice of public comment
accuracy of the Agency’s estimate of the Total estimated burden: 88,569 hours period.
burden of the proposed collection of (per year). Burden is defined at 5 CFR
information, including the validity of SUMMARY: The Environmental Protection
1320.03(b). Agency (EPA) is announcing a 60-day
the methodology and assumptions used;
(iii) enhance the quality, utility, and Total estimated cost: $14,865,812 (per public comment period associated with
clarity of the information to be year), includes $11,063,780 (per year) the release of two draft toxicity
collected; and (iv) minimize the burden operation & maintenance costs. There assessments for public comment:
of the collection of information on those are no capital costs. • Draft Human Health Toxicity
who are to respond, including through Values for Hexafluoropropylene Oxide
Changes in estimates: There is a
the use of appropriate automated (HFPO) Dimer Acid and its Ammonium
decrease of 2,707 hours in the total
electronic, mechanical, or other Salt (GenX Chemicals).
respondent burden compared with the • Draft Human Health Toxicity
technological collection techniques or ICR approved by OMB in July 2015 due
other forms of information technology, Values for Perfluorobutane Sulfonic
to the respondents no longer needing to Acid (PFBS) and Related Compound
e.g., permitting electronic submission of prepare and submit schedules for the
responses. The EPA will consider the Potassium Perfluorobutane Sulfonate.
adoption of new or revised WQS and The EPA developed the draft
comments received and amend the ICR
identification and use of a beach assessments to provide the health effects
as appropriate. The final ICR package
will then be submitted to OMB for notification threshold (BNT). The EPA information available for GenX
review and approval. At that time, the no longer requests respondents submit chemicals and PFBS and describe how
EPA will issue another Federal Register these schedules because they are using that information was used to derive
notice to announce the submission of BNTs or alternate BNTs and have either draft toxicity values. These draft toxicity
the ICR to OMB and the opportunity to adopted new or revised WQS or are in assessments underwent independent,
submit additional comments to OMB. the process of doing so. This decrease in external expert peer review in June-July
Abstract: The Beaches Environmental hours is partially offset by one 2018. Following closure of this 60-day
Assessment and Coastal Health additional tribe having qualified for a public comment period, the EPA will
(BEACH) Act amends the Clean Water BEACH grant. The total respondent cost consider the comments, revise the draft
Act (CWA) in part and authorizes the decreased by $587,496. The decrease in documents, and consider the need for
U.S. Environmental Protection Agency cost is partially offset by slight increases additional peer review, as appropriate,
(EPA) to award BEACH Act Program in the salary rates. The O&M decreased and then publish final toxicity
Development and Implementation assessments. The toxicity assessments
by $289,366 due to a reduction in the
Grants to coastal and Great Lakes states, for GenX chemicals and PFBS are
total number of beaches (affecting
tribes, and territories (collectively scientific and technical reports that
O&M). The number of beaches reported
referred to as jurisdictions) for their include toxicity values associated with
by the jurisdictions varies from year to potential noncancer health effects
beach monitoring and notification
year for many reasons. Reasons for following oral exposure (in this case,
programs. The grants assist those
removing beaches include the oral reference doses [RfDs]). These
jurisdictions to develop and implement
a consistent approach to monitor destruction of beaches by natural assessments evaluate human health
recreational water quality; assess, disasters, change in beach ownership, hazards. The toxicity assessments and
manage, and communicate health risks and existing beaches being combined the values contained within are not risk
from waterborne microbial within a jurisdiction’s monitoring and assessments as they do not include
contamination; notify the public of notification program. exposure assessments or provide a risk
pollution occurrences, and post beach Dated: November 13, 2018. characterization. Further, the toxicity
advisories and closures to prevent Deborah G. Nagle,
assessments do not address the legal,
public exposure to microbial pathogens. political, social, economic, or technical
Acting Director, Office of Science and
To qualify for a BEACH Act Grant, a considerations involved in risk
khammond on DSK30JT082PROD with NOTICES
Technology.
jurisdiction must submit information to management. When issued, the toxicity
[FR Doc. 2018–25423 Filed 11–20–18; 8:45 am]
the EPA documenting that its beach assessments can be used by the EPA,
monitoring and notification program is BILLING CODE 6560–50–P states, tribes, and local communities,
consistent with performance criteria along with specific exposure and other
outlined in the National Beach relevant information, to determine,
Guidance and Required Performance under the appropriate regulations and
Criteria for Grants, 2014 Edition. statutes, if and when it is necessary to
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![58770 Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices
Characterizing risk involves integrating begin using the final values in relevant Dated: November 14, 2018.
information on hazard, dose-response, exposure scenarios to generate risk David P. Ross,
and exposure. For further details about assessments to support risk management Assistant Administrator, Office of Water.
risk assessments see: https:// decisions. [FR Doc. 2018–25422 Filed 11–20–18; 8:45 am]
www.epa.gov/risk/conducting-human- BILLING CODE 6560–50–P
health-risk-assessment. V. Solicitation of Public Comment
When issued, the toxicity values for
GenX chemicals and PFBS can be During the 60-day comment period,
the EPA is soliciting public comments FEDERAL DEPOSIT INSURANCE
combined with specific exposure
information (Step 3. Exposure regarding the science and technical CORPORATION
Assessment) by government and private approaches used in the derivation of the
draft toxicity assessments for GenX FDIC Systemic Resolution Advisory
entities to help characterize (Step 4. Committee; Notice of Meeting
Risk Characterization) potential public chemicals and PFBS.
health risks associated with exposure to In the PFBS assessment, due to the AGENCY: Federal Deposit Insurance
these chemicals. Thus, once the GenX lack of epidemiological studies Corporation (FDIC).
chemicals and PFBS assessments are demonstrating adverse effects in ACTION: Notice of open meeting.
issued, the EPA will work with our humans, the EPA derived candidate
state, tribal, and local partners to SUMMARY: In accordance with the
subchronic RfDs (see Section 6.1.1 of Federal Advisory Committee Act, notice
provide technical assistance, including the toxicity assessment) and candidate
information about appropriate is hereby given of a meeting of the FDIC
chronic RfDs (see Section 6.1.2 of the Systemic Resolution Advisory
regulations and statutes, as they begin
toxicity assessment) for both thyroid Committee, which will be held in
considering the final values in relevant
exposure scenarios. It is the risk effects and kidney effects in rodent Washington, DC. The Advisory
management part of the risk assessment/ toxicity studies. In light of the Committee will provide advice and
risk management paradigm where the consistent observation of the thyroid recommendations on a broad range of
supporting science, as well as statutory effects across life stages and the greater policy issues regarding the resolution of
and legal considerations, risk dose-response sensitivity, relative to the systemically important financial
management options, public health kidney effects, the EPA is proposing to companies.
considerations, cost/benefit base the overall subchronic and chronic DATES: Thursday, December 6, 2018,
considerations, economic factors, social RfDs on the thyroid effects and is from 9:00 a.m. to 4:00 p.m.
factors, and other considerations are requesting public review and comment ADDRESSES: The meeting will be held in
weighed. on this proposal in addition to the the FDIC Board Room on the sixth floor
The EPA recognizes that humans have approaches and conclusions in the of the FDIC Building located at 550 17th
the potential to be exposed to complex PFBS assessment. Additionally, as Street NW, Washington, DC.
mixtures of PFAS and other chemicals described in Section 6.1 of the PFBS
and pathogens through drinking water FOR FURTHER INFORMATION CONTACT:
toxicity assessment, decreased serum Requests for further information
and other exposure sources. The EPA’s total T4 (thyroxine) in newborn mice
draft assessments for GenX chemicals concerning the meeting may be directed
was used as the basis for the thyroid- to Mr. Robert E. Feldman, Committee
and PFBS focus solely on the potential related candidate RfDs. Peer reviewers
human health effects associated with Management Officer of the FDIC, at
provided comments on thyroid effects (202) 898–7043.
oral exposure to each chemical; they do
and this choice of endpoint. See pages SUPPLEMENTARY INFORMATION:
not consider potential cumulative
(mixture) effects of GenX chemicals and 15–25 and 31–32 in the Response to Agenda: The agenda will include a
PFBS or their possible interactions with Peer Review Comments on the Draft discussion of a range of issues and
other PFAS and/or other chemicals. Human Health Toxicity Values for developments related to the resolution
This would involve a more complex Perfluorobutane Sulfonic Acid (CASRN of systemically important financial
assessment that would need to consider 375–73–5) and Related Compound companies. The agenda may be subject
and evaluate mechanisms of action and Potassium Perfluorobutane Sulfonate to change. Any changes to the agenda
endpoints of concern for each of the (CASRN 29420–49–3) for the array of will be announced at the beginning of
chemicals in the mixture. peer review comments on these topics the meeting.
and the EPA’s responses. These Type of Meeting: The meeting will be
IV. Why is the EPA releasing draft open to the public, limited only by the
supporting documents are available in
toxicity assessments for these space available on a first-come, first-
chemicals? the public docket for this ICR (under
Docket ID number EPA–HQ–OW–2018– served basis. For security reasons,
The EPA is issuing the draft toxicity 0614. Comments from the public are members of the public will be subject to
assessments for PFBS and GenX requested on the thyroid effects, this security screening procedures and must
chemicals for public comment to give choice of endpoint, as well as the present a valid photo identification to
interested stakeholders and the public discussion on thyroid hormone enter the building. The FDIC will
an opportunity to provide input to the provide attendees with auxiliary aids
economy in humans and animals (see
Agency. The public will have 60 days (e.g., sign language interpretation)
Section 6.1 of the PFBS toxicity
after publication in the Federal Register required for this meeting. Those
assessment).
to provide input. At the end of the attendees needing such assistance
khammond on DSK30JT082PROD with NOTICES
comment period, the EPA will evaluate These draft assessments are not final should call (703) 562–6067 (Voice or
the input, make appropriate revisions, as described in the EPA’s information TTY) at least two days before the
and finalize the toxicity assessments. quality guidelines, and do not represent meeting to make necessary
Once the toxicity assessments are Agency policy or views. The EPA will arrangements. Written statements may
issued, the EPA will work with our consider all public comments submitted be filed with the committee before or
state, tribal, and local partners to in response to this notice when revising after the meeting. This meeting of the
provide technical assistance, as they these documents. FDIC Systemic Resolution Advisory
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Document Created: 2018-11-21 03:12:08
Document Modified: 2018-11-21 03:12:08
| 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 public comment period. | |
| Dates | Comments must be received on or before January 22, 2019. | |
| 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] | |
| FR Citation | 83 FR 58768 |
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