Addition of Certain Per- and Polyfluoroalkyl Substances; Community Right-to-Know Toxic Chemical Release Reporting
| Published date | 04 December 2019 |
| Citation | 84 FR 66369 |
| Record Number | 2019-26034 |
| Section | Proposed rules |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 233 (Wednesday, December 4, 2019)
[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Proposed Rules]
[Pages 66369-66373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26034]
[[Page 66369]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2019-0375; FRL-10002-70]
RIN 2070-AK51
Addition of Certain Per- and Polyfluoroalkyl Substances;
Community Right-to-Know Toxic Chemical Release Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: In this advance notice of proposed rulemaking (ANPRM), EPA is
soliciting information from the public as EPA considers proposing a
future rule on adding certain per- and polyfluoroalkyl substances
(PFAS) to the list of toxic chemicals subject to reporting under
section 313 of the Emergency Planning and Community Right-to-Know Act
(EPCRA) and section 6607 of the Pollution Prevention Act (PPA). In this
ANPRM, EPA outlines what PFAS are, why the Agency is considering adding
certain PFAS to EPCRA section 313, what listing actions are being
considered, who may be required to report, the current understanding of
hazard concerns for PFAS, EPA's hazard assessments on PFAS, and other
information available on these chemicals. In considering a chemical for
addition to the EPCRA section 313 list, EPA bases its listing decision
on the chemical's hazard (i.e., toxicity), not the risk (i.e., toxicity
plus potential exposures) related to that chemical. EPA is requesting
comment on which, if any, PFAS should be evaluated for listing, how to
list them, and what would be appropriate reporting thresholds given
their persistence and bioaccumulation potential. Lastly, EPA asks for
any additional data to inform the Agency's evaluation and determination
of which PFAS may meet the EPCRA section 313 listing criteria.
DATES: Comments must be received on or before February 3, 2020.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
TRI-2019-0375, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets#hq.
All documents in the docket are listed on http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information or
other information the disclosure of which is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through http://www.regulations.gov. Additional instructions on visiting
the docket, along with more information about dockets generally, is
available at http://www.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Daniel R. Bushman, Toxics Release Inventory Program Division (7410M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 566-0743; email: [email protected].
For general information contact: The Emergency Planning and
Community Right-to-Know Hotline; telephone numbers: toll free at (800)
424-9346 (select menu option 3) or (703) 348-5070 in the Washington, DC
Area and International; or go to https://www.epa.gov/home/epa-hotlines.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or otherwise use PFAS. The following list of North American
Industrial Classification System (NAICS) codes is not intended to be
exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
Facilities included in the following NAICS manufacturing
codes (corresponding to Standard Industrial Classification (SIC) codes
20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324,
325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*,
211130*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120,
511130, 511140*, 511191, 511199, 512230*, 512250*, 519130*, 541713*,
541715* or 811490*. *Exceptions and/or limitations exist for these
NAICS codes.
Facilities included in the following NAICS codes
(corresponding to SIC codes other than SIC codes 20 through 39):
212111, 212112, 212113 (corresponds to SIC code 12, Coal Mining (except
1241)); or 212221, 212222, 212230, 212299 (corresponds to SIC code 10,
Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113,
221118, 221121, 221122, 221330 (limited to facilities that combust coal
and/or oil for the purpose of generating power for distribution in
commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric
Utilities); or 424690, 425110, 425120 (limited to facilities previously
classified in SIC code 5169, Chemicals and Allied Products, Not
Elsewhere Classified); or 424710 (corresponds to SIC code 5171,
Petroleum Bulk Terminals and Plants); or 562112 (limited to facilities
primarily engaged in solvent recovery services on a contract or fee
basis (previously classified under SIC code 7389, Business Services,
NEC)); or 562211, 562212, 562213, 562219, 562920 (limited to facilities
regulated under the Resource Conservation and Recovery Act, subtitle C,
42 U.S.C. 6921 et seq.) (corresponds to SIC code 4953, Refuse Systems).
Federal facilities.
A more detailed description of the types of facilities covered by
the NAICS codes subject to reporting under EPCRA section 313 can be
found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility would be
affected by this action, you should carefully examine the applicability
criteria in part 372, subpart B of Title 40 of the Code of Federal
Regulations. Federal facilities are required to report under Executive
Order 13834 (https://www.govinfo.gov/content/pkg/FR-2018-05-22/pdf/2018-11101.pdf) as explained in the Implementing Instructions from the
Council on Environmental Quality (https://www.sustainability.gov/pdfs/eo13834_instructions.pdf). If you have
[[Page 66370]]
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. What action is under consideration by the Agency?
EPA is considering proposing a rule to add certain PFAS to the list
of toxic chemicals subject to reporting under EPCRA section 313 and
section 6607 of the PPA (more commonly known as the Toxics Release
Inventory (TRI)). EPA is also considering establishing reporting
thresholds for PFAS that are lower than the usual statutory thresholds
(25,000 pounds for manufacturing or processing and 10,000 pounds for
otherwise using listed chemicals) due to concerns for their
environmental persistence and bioaccumulation potential.
C. What is the Agency's authority for this potential action?
This action is issued under EPCRA sections 313(d) and 328, 42
U.S.C. 11023 et seq., and PPA section 6607, 42 U.S.C. 13106. EPCRA is
also referred to as Title III of the Superfund Amendments and
Reauthorization Act of 1986.
Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually to EPA and the States. These facilities must also report
pollution prevention and recycling data for such chemicals, pursuant to
section 6607 of the PPA, 42 U.S.C. 13106. Congress established an
initial list of toxic chemicals that was comprised of 308 individually
listed chemicals and 20 chemical categories.
EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets criteria for these actions. EPCRA section 313(d)(2)
states that EPA may add a chemical to the list if any of the listing
criteria in EPCRA section 313(d)(2) are met. Therefore, to add a
chemical, EPA must demonstrate that at least one criterion has been
met, but need not determine whether any other criterion has been met.
Conversely, to remove a chemical from the list, EPCRA section 313(d)(3)
dictates that EPA must demonstrate that none of the criteria in ECPRA
section 313(d)(2) have been met. The listing criteria in EPCRA section
313(d)(2)(A) through (C) are as follows:
The chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
The chemical is known to cause or can reasonably be
anticipated to cause in humans: Cancer or teratogenic effects, or
serious or irreversible reproductive dysfunctions, neurological
disorders, heritable genetic mutations, or other chronic health
effects.
The chemical is known to cause or can be reasonably
anticipated to cause, because of its toxicity, its toxicity and
persistence in the environment, or its toxicity and tendency to
bioaccumulate in the environment, a significant adverse effect on the
environment of sufficient seriousness, in the judgment of the
Administrator, to warrant reporting under this section.
EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the EPCRA section
313(d)(2)(B) criterion as the ``chronic human health effects
criterion;'' and the EPCRA section 313(d)(2)(C) criterion as the
``environmental effects criterion.''
In a final rule that added 286 chemicals and chemical categories to
the TRI list, EPA published in the Federal Register of November 30,
1994 (59 FR 61432) (FRL-4922-2), a statement clarifying its
interpretation of the EPCRA section 313(d)(2) criteria for modifying
the EPCRA section 313 list of toxic chemicals. EPA's interpretation of
the EPCRA section 313 listing criteria addressed a number of issues
including EPA's authority to add chemical categories and EPA's policy
on the use of exposure for chemicals that are toxic only at high doses/
concentrations.
II. Background Information
A. What is TRI?
EPCRA section 313, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to Pollution Prevention Act
section 6607, 42 U.S.C. 13106. Note that TRI does not cover all
chemicals, facilities, or types of pollution.
TRI provides information about releases of toxic chemicals from
covered facilities throughout the United States; however, TRI data do
not reveal whether or to what degree the public is exposed to listed
chemicals. TRI data can, in conjunction with other information, be used
as a starting point in evaluating such exposures and the risks posed by
such exposures. The determination of potential risk to human health
and/or the environment depends upon many factors, including the
toxicity of the chemical, the fate of the chemical in the environment,
and the amount and duration of human or other exposure to the chemical.
For more information on TRI, visit the TRI website at www.epa.gov/tri. Additionally, via this website, EPA provides a Factors to Consider
When Using TRI Data document, which helps explain some of the uses, as
well as limitations, of data collected by TRI.
B. What are PFAS?
PFAS are synthetic organic compounds that do not occur naturally in
the environment. PFAS contain an alkyl carbon chain on which the
hydrogen atoms have been partially or completely replaced by fluorine
atoms. The strong carbon-fluorine bonds of PFAS make them resistant to
degradation and thus highly persistent in the environment (Refs. 1 and
2). Some of these chemicals have been used for decades in a wide
variety of consumer and industrial products (Ref. 1). Some PFAS have
been detected at high levels in wildlife indicating that at least some
PFAS have the ability to bioaccumulate (Ref. 2). Some PFAS can
accumulate in humans and remain in the human body for long periods of
time (e.g., months to years) (Refs. 1, 2, and 3). As noted in EPA's
Action Plan (Ref. 1), because of the widespread use of PFAS in commerce
and their tendency to persist in the environment, most people in the
United States have been exposed to PFAS. As a result, several PFAS have
been detected in human blood serum (Refs. 1, 2 and 4).
C. Why is EPA considering adding PFAS to the TRI?
Some PFAS may be toxic, persistent in the environment, and
accumulate in wildlife and humans. Therefore, releases of some PFAS to
the environment and potential human exposure may be of concern. One
source of potential exposure to PFAS are releases from industrial
facilities that manufacture, process, or otherwise use PFAS.
Information on the releases and waste management quantities from such
facilities could help EPA and the public identify some potential
sources of exposure to PFAS. The TRI is a tool that EPA can use to
collect such information. As noted in the EPA Action Plan:
``Currently, no PFAS chemicals are included on the list of
chemicals required to report to TRI; however, the EPA is considering
whether to add
[[Page 66371]]
PFAS chemicals. In considering listing, the EPA must determine whether
data and information are available to fulfill the listing criteria and
the extent and utility of the data that would be gathered. For example,
hazard data required for TRI listing may be readily available for
certain PFAS chemicals, but not others. In addition, in considering if
TRI will provide useful information to stakeholders, the EPA also will
consider if those PFAS are still active in commerce. The process for
listing includes notice and comment rulemaking to list PFAS chemicals
for reporting prior to adding these chemicals to the TRI for annual
reporting.'' (Ref. 1)
As the first step in the process of adding certain PFAS to the TRI,
EPA is issuing this ANPRM to allow all stakeholders the opportunity to
comment on the various aspects of adding certain PFAS to the TRI toxic
chemical list. Note that adding certain PFAS to the TRI could help
inform discussions related to risks to human health and the environment
but the information collected through TRI, as previously indicated,
would not capture all sources of PFAS releases.
III. What TRI listing actions are being considered?
Currently, approximately 600 PFAS are manufactured (including
imported) and/or used in the United States (Ref. 5). The two PFAS that
have been studied the most are perfluorooctanoic acid (PFOA) and
perfluorooctane sulfonate (PFOS). Due to a voluntary phaseout under the
2010/2015 PFOA Stewardship Program, PFOA and PFOS are no longer
produced domestically by the companies participating in the Program.
However, PFOA and PFOS may still be produced domestically, imported,
and used by companies not participating in the PFOA Stewardship Program
(Ref. 6). PFOA and PFOS may also be present in imported articles. PFAS
such as hexafluoropropylene oxide (HFPO) dimer acid (Chemical Abstract
Service Registry Number (CASRN) 13252-13-6) and its ammonium salt
(CASRN 62037-80-3), both commonly referred to as GenX, and
perfluorobutane sulfonic acid (PFBS) (CASRN 375-73-5) and its salt
potassium perfluorobutane sulfonate (CASRN 29420-49-3)), are some
examples of short-chain PFAS that have been developed to replace long-
chain PFOA and PFOS, respectively. Compared to PFOA and PFOS, most
replacement PFAS tend to have less information available about their
potential toxicity to human and ecological populations. Through this
ANPRM process, EPA is seeking information to determine which PFAS
currently active in commerce have sufficient toxicity information
available to meet the EPCRA section 313(d)(2) listing criteria. EPA is
considering whether to add any PFAS currently active in commerce for
which hazard assessments show that they meet the EPCRA section
313(d)(2) listing criteria. Note that one factor EPA considers when
determining whether to add a chemical to the TRI list is whether
reporting would occur on the chemical if it were to be added.
In addition, for any PFAS that meet the listing criteria, EPA is
considering adding these compounds to the list of chemicals of special
concern (Sec. 372.28) and establishing lower reporting thresholds. In
the past EPA has lowered the reporting thresholds for persistent,
bioaccumulative, and toxic (PBT) chemicals (October 29, 1999, 64 FR
58666 (FRL-6389-11)). For PBT chemicals, with one exception, EPA
established two reporting thresholds, 100 pounds for PBT chemicals and
10 pounds for highly PBT chemicals (i.e., those PBT chemicals with very
high persistence and bioaccumulation values). Certain PFAS may have
persistence and bioaccumulation properties similar to other PBT
chemicals where even small amounts of release present a concern. To
appropriately capture release information of PFAS, EPA is considering
establishing reporting thresholds lower than the statutory thresholds
of 25,000 pounds for manufacturing or processing and 10,000 pounds for
otherwise using listed chemicals.
PFAS, that meet the ECPRA section 313 listing criteria, could be
listed as individual chemicals or as members of PFAS chemical
categories. For example, EPA's ``Health Effects Support Document for
Perfluorooctane Sulfonate (PFOS)'' (Ref. 7) states that PFOS (CASRN
1763-23-1) is commonly produced as a potassium salt (CASRN 2795-39-3)
and that, while the CASRN given is for linear PFOS, the toxicity
studies are commonly based on a mixture of linear and branched PFOS.
Therefore, the reference dose (RfD) derived in the 2016 Health Effects
Support Document applies to the total linear and branched PFOS. For
PFOS it would seem appropriate to create a TRI chemical category that
includes all linear and branched isomers of PFOS and any salts of PFOS.
PFOA has similar considerations, as may other PFAS that may warrant
reporting as a category rather than as individually listed chemicals.
EPA may also consider establishing a single chemical category for all
PFAS, however, a single category would be of limited use since it would
not provide any information about which PFAS are being released and/or
managed as waste.
IV. What are the hazard concerns for PFAS?
Some PFAS are known to persist in the environment because they are
resistant to degradation and have been shown to bioaccumulate in
wildlife and humans (Refs. 1 and 2). There are also concerns that some
PFAS may cause adverse human health effects, including reproductive,
developmental, cancer, liver, immune, thyroid, and other effects (Refs.
1, 2, 8, and 9).
Based on their physicochemical properties and measured
environmental concentrations, some PFAS are considered to be
environmentally persistent chemicals (Refs. 1 and 2). In general, most
PFAS are resistant to environmental degradation due to their strong
carbon-fluorine bonds (Refs. 1 and 2). While PFAS chain length and
chemical structure can have implications for environmental fate, PFAS
are typically resistant to biodegradation, photooxidation, direct
photolysis, and hydrolysis which is consistent with their persistence
in soil and water (Ref. 2). Some PFAS, can also degrade or be
metabolized to other PFAS such as PFOA or PFOS (Ref. 2). PFAS have been
detected in air, surface water, groundwater, drinking water, soil, and
food (Ref. 2). The presence of PFAS in many parts of the world,
including the Arctic, indicate that long-range transport is possible
(Ref. 2).
Under the TRI, bioaccumulation, to the extent it happens, is part
of the hazard concerns and will be considered both in the listing
criteria and in considering lower reporting thresholds.
Bioconcentration factors (BCFs) estimated from an octanol-water
partition coefficient (Kow) or measured in aquatic tests,
have typically been used to assess bioaccumulation potential.
Kow and the associated BCFs are based on the partitioning of
organic chemicals into octanol or lipids. However, for PFAS such as
PFOA and PFOS partitioning appears to be more related to their protein
binding properties than to their lipophilicity (Refs. 8 and 9). Since
Kow does not provide a reliable estimate of bioaccumulation
potential for these chemicals, field evidence of bioaccumulation is
preferable. Field measured bioaccumulation factors (BAFs), and
biomagnification factors (BMFs) or trophic magnification factors (TMFs)
are considered more appropriate
[[Page 66372]]
indicators of the potential for PFAS, such as PFOA and PFOS, to
accumulate in fish, other wildlife, and humans (Refs. 8, 9, 10, and
11). The trophic magnification data for PFOA and PFOS was deemed
sufficient to consider them to be bioaccumulative by the Stockholm
Convention Persistent Organic Pollutants Review Committee in 2015 (Ref.
12).
While the toxicity of PFOA and PFOS has been studied extensively,
there is less data available for other PFAS (Ref. 2). Differences in
PFAS chain length and chemical structure can have implications for
environmental fate, bioaccumulation, metabolism, and toxicity (Ref. 1).
As part of EPA's PFAS Action Plan, the Agency is continuing to collect,
systematically review, and evaluate available toxicity data for other
PFAS that may help determine whether exposure to structurally similar
PFAS results in similar toxic effects (Ref. 1).
V. What EPA hazard assessments and other toxicity data are available
for PFAS?
To date EPA has published two assessments of PFAS: (1) Health
Effects Support Document for Perfluorooctane Sulfonate (PFOS) and (2)
Health Effects Support Document for Perfluorooctanoic Acid (PFOA)
(Refs. 7 and 13). These two documents could be used to determine
whether PFOA, PFOS, and related chemicals (e.g., their salts) meet the
EPCRA section 313(d)(2) listing criteria. EPA has also developed two
new draft PFAS assessments for public comment: (1) Human Health
Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and Its
Ammonium Salt (CASRN 13252-13-6 and CASRN 62037-80-3) Also Known as
``GenX Chemicals'' and (2) Human Health Toxicity Values for
Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound
Potassium Perfluorobutane Sulfonate (PFBS) (CASRN 29420-49-3) (Refs. 14
and 15). Once these documents are finalized, EPA expects these
assessments will provide a basis for determining whether GenX chemicals
and PFBS meet the EPCRA section 313(d)(2) listing criteria.
In addition, EPA is working on hazard assessments for the following
PFAS containing varying degrees of available toxicity information
relevant for human health assessment purposes: Perfluorononanoic acid
(PFNA), perfluorobutanoic acid (PFBA), perfluorodecanoic acid (PFDA),
perfluorohexanoic acid (PFHxA), and perfluorohexane sulfonic acid
(PFHxS) (Ref. 16). Once finalized, EPA expects these assessments will
provide a basis for determining whether these chemicals meet the EPCRA
section 313(d)(2) listing criteria.
EPA has also collected scientific literature on approximately 30
PFAS. This list of PFAS and the available scientific literature is
posted at https://hero.epa.gov/hero/index.cfm/litbrowser/public/#PFAS.
For some of these PFAS, there may be epidemiological and/or
experimental animal toxicity data available for review and evaluation
of suitability to inform potential human health effects.
Lastly, EPA is collaborating with the National Toxicology Program
(NTP) to study individual PFAS and PFAS as a chemical class.
Specifically, the NTP has conducted toxicology studies to evaluate and
identify the adverse effects of certain PFAS chemicals including PFBS,
PFHxS, PFOS, PFHxA, PFOA, PFNA, and PFDA (https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm). NTP continues to assess the
potential health effects of PFAS through a large multi-faceted research
effort (https://ntp.niehs.nih.gov/results/areas/pfas/index.html).
The Agency relies on EPA hazard assessments and externally peer-
reviewed hazard assessments from other federal agencies in making
determinations as to whether a chemical meets the EPCRA section 313
listing criteria. EPA will consider all PFAS assessments on the human
health and environmental effects of PFAS that are available from all
sources, including those being conducted by other federal agencies.
VI. What information is EPA requesting?
EPA is seeking comments on which of the approximately 600 PFAS
currently active in U.S. commerce the Agency should consider evaluating
for potential addition to the EPCRA section 313 list of toxic
chemicals. EPA would also like to receive comments on whether there are
data available to inform how to list PFAS, i.e., as individual chemical
listings, as a single category, as multiple categories or as a
combination of individual listings and category listings. Note that
when chemicals are listed as a category, the TRI reports submitted
would include combined data for all members of the category, such that
there are no data reported specific to any individual member of the
category.
EPA is also seeking comments on the appropriate reporting
thresholds for PFAS. Reporting thresholds should be set at an
appropriate level to capture most of the releases of PFAS from the
facilities that submit reports under EPCRA section 313. Finally, EPA
would like to receive any additional information on human health and
environmental toxicity, persistence, and bioaccumulation of PFAS that
would help determine if they meet the EPCRA section 313 listing
criteria.
VII. What are the next steps EPA will take?
EPA intends to carefully review all the comments and information
received in response to this ANPRM, as well as previously collected and
assembled studies. Once that review is completed, EPA may supplement
the collected information with additional hazard assessments to
determine whether some PFAS meet the EPCRA section 313(d)(2) criteria.
Should EPA decide to move forward with this action, the next step will
be to publish a proposed rule to add certain PFAS to the EPCRA section
313 toxic chemical list and set the appropriate reporting thresholds.
At that time, the public will have the opportunity to comment on EPA's
proposal.
VIII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not itself physically located in the
docket. For assistance in locating these other documents, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
1. USEPA. EPA's Per- and Polyfluoroalkyl Substances (PFAS) Action
Plan. EPA 823R18004. U.S. Environmental Protection Agency,
Washington, DC. February 2019. Available from: https://www.epa.gov/pfas/epas-pfas-action-plan.
2. ATSDR. Agency for Toxic Substances and Disease Registry.
Toxicological Profile for Perfluoroalkyls--Draft for Public Comment.
June 2018. Available from: https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.
3. USEPA. Basic Information on PFAS. U.S. Environmental Protection
Agency, Washington, DC. Available from: https://www.epa.gov/pfas/basic-information-pfas.
4. Department of Health and Human Services, Centers for Disease
Control and Prevention. Fourth National Report on Human Exposure to
Environmental Chemicals. Pages 247-257, 2009. Available from:
https://www.cdc.gov/exposurereport/pdf/fourthreport.pdf.
5. USEPA. Toxic Substances Control Act (TSCA) Chemical Substance
Inventory. U.S. Environmental Protection Agency, Washington, DC.
Available from: https://www.epa.gov/tsca-inventory.
[[Page 66373]]
6. USEPA. Fact Sheet: 2010/2015 PFOA Stewardship Program. Available
from: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program.
7. USEPA. Health Effects Support Document for Perfluorooctane
Sulfonate (PFOS). EPA 822-R-16-002. U.S. Environmental Protection
Agency, Washington, DC. May 2016. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfos_hesd_final_508.pdf.
8. USEPA. Drinking Water Health Advisory for Perfluorooctanoic Acid
(PFOA). EPA 822-R-16-005. U.S. Environmental Protection Agency,
Washington, DC. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_health_advisory_final_508.pdf.
9. USEPA. Drinking Water Health Advisory for Perfluorooctane
Sulfonate (PFOS). EPA 822-R-16-002. U.S. Environmental Protection
Agency, Washington, DC. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfos_health_advisory_final_508.pdf.
10. USEPA. Methodology for Deriving Ambient Water Quality Criteria
for the Protection of Human Health (2000) Technical Support Document
Volume 2: Development of National Bioaccumulation Factors. Office of
Water, Office of Science and Technology. December 2003 (EPA-822-R-
03-030). Available from: https://www.epa.gov/sites/production/files/2018-10/documents/methodology-wqc-protection-hh-2000-volume2.pdf.
11. Gobas, F.A.P.C., Watze de Wolf, W., Burkhard, L.P., Verbruggen,
E., I and Plotzke, K. 2009. Revisiting Bioaccumulation Criteria for
POPs and PBT Assessments. Integrated Environmental Assessment and
Management--Volume 5, Number 4--pp. 624-637.
12. UNEP. Proposal to list pentadecafluorooctanoic acid (CAS No:
335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related
compounds in Annexes A, B and/or C to the Stockholm Convention on
Persistent Organic Pollutants. United Nations Environmental Program.
2015. Available from: http://chm.pops.int/TheConvention/POPsReviewCommittee/Meetings/POPRC11/POPRC11Documents/tabid/4573/.
13. USEPA. Health Effects Support Document for Perfluorooctanoic
Acid (PFOA). EPA 822-R-16-003. U.S. Environmental Protection Agency,
Washington, DC. May 2016. Available from: https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_hesd_final-plain.pdf.
14. USEPA. Human Health Toxicity Values for Hexafluoropropylene
Oxide (HFPO) Dimer Acid and Its Ammonium Salt (CASRN 13252-13-6 and
CASRN 62037-80-3) Also Known as ``GenX Chemicals. Public Comment
Draft. EPA-823-P-18-001. U.S. Environmental Protection Agency,
Washington, DC. November 2018. Available from: https://www.epa.gov/sites/production/files/2018-11/documents/genx_public_comment_draft_toxicity_assessment_nov2018-508.pdf.
15. USEPA. Human Health Toxicity Values for Perfluorobutane Sulfonic
Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane
Sulfonate (CASRN 29420-49-3). Public Comment Draft. EPA-823-R-18-
307. U.S. Environmental Protection Agency, Washington, DC. November
2018. Available from: https://www.epa.gov/sites/production/files/2018-11/documents/pfbs_public_comment_draft_toxicity_assessment_nov2018-508.pdf.
16. USEPA. IRIS Program Outlook. A Message from the IRIS Program
(April 2019). U.S. Environmental Protection Agency, Washington, DC.
Available from: https://www.epa.gov/sites/production/files/2019-04/documents/iris_program_outlook_apr2019.pdf.
IX. Statutory and Executive Order Reviews
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Any changes made in response to OMB recommendations
have been documented in the docket for this action. Because this action
does not propose or impose any requirements, and instead seeks comments
and suggestions for the Agency to consider in possibly developing a
subsequent proposed rule, the various statutes and Executive Orders
that normally apply to rulemaking do not apply in this case. Should EPA
subsequently determine to pursue a rulemaking, EPA will address the
statutes and Executive Orders as applicable to that rulemaking.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.
Dated: November 25, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-26034 Filed 12-3-19; 8:45 am]
BILLING CODE 6560-50-P
