PFOA-PFOS Designation_2050-AH09 Propose Rule - Add Date
                                                                      6560-50-P
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 302
[EPA-HQ-OLEM-2019-0341; FRL-7204-02-OLEM]
RIN 2050-AH09
Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances
AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Proposed rule.
SUMMARY:  Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended ("CERCLA" or "Superfund"), the Environmental Protection Agency (EPA or the Agency) is proposing to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances. CERCLA authorizes the Administrator to promulgate regulations designating as hazardous substances such elements, compounds, mixtures, solutions, and substances which, when released into the environment, may present substantial danger to the public health or welfare or the environment.
DATES: Comments must be received on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES:  You may send comments, identified by Docket ID No. EPA-HQ-OLEM-2019-0341, by any of the following methods:
	:: Federal eRulemaking Portal: https://www.regulations.gov (our preferred method). Follow the online instructions for submitting comments.
	:: Mail: U.S. Environmental Protection Agency, EPA Docket Center, OLEM Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
	:: Hand Delivery or Courier (by scheduled appointment only): EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m. - 4:30 p.m., Monday  -  Friday (except Federal Holidays).
      Instructions: All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to https://www.regulations.gov/, including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the "Public Participation" heading of the SUPPLEMENTARY INFORMATION section of this document. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are open to the public by appointment only to reduce the risk of transmitting COVID-19. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:  Michelle Schutz, Office of Superfund Remediation and Technology Innovation (5202T), Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460; telephone number<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
      Acronyms and Abbreviations: We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of the preamble and for reference purposes, the EPA defines the following terms and acronyms here:
ADEC Alaska Department of Environmental Conservation
AFFF Aqueous film-forming foam
APFO Ammonium perfluorooctanoate
ATSDR Agency for Toxic Substances and Disease Registry
CDC Center for Disease Control and Prevention
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
CFR Code of Federal Regulations
COP-9 9[th] Conference of Parties
DoD Department of Defense
EALs Environmental action levels
ECF Electrochemical fluorination
EJ Environmental justice
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
EU European Union
FAA Federal Aviation Administration
FR Federal Register
FSANZ Food Standards Australia New Zealand
IARC International Agency for Research of Cancer
ICR Information Collection Request
ILs Initiation levels
LEPC Local Emergency Planning Committee
LHA Lifetime health advisories
MAC Maximum acceptable concentration
MCL Maximum contaminant level
MDH Minnesota Department of Health
mg/kg milligram per kilogram
mg/kg/day milligram per kilogram per day
MRL Minimal risk level
MSC Medium-specific concentration
NAICS North American Industrial Classification System
ng/g nanograms per gram
ng/L nanograms per liter
NRC National Response Center
NJDEP New Jersey Department of Environmental Protection
NHANES National Health and Nutrition Examination Survey
OMB Office of Management and Budget
PADEP Pennsylvania Department of Environmental Protection
PBI Proprietary business information
PCBs Polychlorinated biphenyls
PCL Protective concentration level
PFAS Per- and polyfluoroalkyl substances
PFBS Perfluorobutanesulfonic acid
PFDA Perfluorodecanoic acid
PFHpA Perfluoroheptanoic acid
PFHxA Perfluorohexanoic acid
PFHxS Perfluorohexanesulfonic acid
PFNA Perfluorononanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFOSA Perfluorooctanesulfonamide
pg/m[3] picogram per cubic meter
PHGs Public health goals
POSF Perfluorooctanesulfonyl fluoride
ppt parts per trillion
PRG Preliminary remediation goal
PWS Public water system
RAGs Remedial action guidelines
RCRA Resource Conservation and Recovery Act
REACH Registration Evaluation, Authorisation and Restriction of Chemicals
RFA Regulatory Flexibility Act
RfD Reference dose
RIDEM Rhode Island Department of Environmental Management
RQ Reportable quantity
SAB Science Advisory Board
SALs State action levels
SDWA Safe Drinking Water Act
SERC State Emergency Response Commission
SNURs Significant New Use Rules
TDI Totally daily intake
TEPC Tribal Emergency Planning Committee
TERC Tribal Emergency Response Commission
TRI Toxic Release Inventory
TSCA Toxic Substances Control Act
UCMR Unregulated Contaminant Monitoring Rule
UK United Kingdom
UMRA Unfunded Mandates Reform Act
UNEP United Nations Environment Programme
U.S. United States
U.S.C. United States Code
WQCC Water Quality Control Commission
WWTP Wastewater treatment plant
Table of Contents.
I. Public Participation
II. General Information
 Does this action apply to me?
 What are PFOA and PFOS?
 Which entities are potentially affected by this action?
 Are there liabilities associated with this proposed action?
 What action is the Agency taking?
 What is the Agency's authority for taking this action?
 What are the incremental costs and benefits of this action?
III. Background
IV. Addition of PFOA and PFOS, Including Their Salts and Structural Isomers, to List of Hazardous Substances
A. Why is EPA proposing to designate PFOA and PFOS as hazardous substances?
B. What is the Evidence for Designation of PFOA and PFOS as Hazardous Substances?
a. Chemical/Physical Characteristics
b. Toxicity and Toxicokinetics
c. Environmental Prevalence
d. Manufacturing and Use
e. Regulatory and Advisory Status at EPA, Other Federal, State and International Agencies
i. EPA Actions
ii. Actions by Other Federal Agencies
iii. State Actions
iv. Enforcement
v. International Actions
f. Conclusion
V. Effect of Designation
A. Default Reportable Quantity
B. Reporting and Notification Requirements for CERCLA Hazardous Substances
C. Scope of This Rulemaking
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review, and Executive Order 13563: Improving Regulation and Regulatory Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

I.	Public Participation

A.	Written Comments

      Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2019-0341, 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 to EPA's docket at https://www.regulations.gov any information you consider to be Propriety Business Information (PBI) 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 PBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
      Due to public health concerns related to COVID-19, the EPA Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.
      The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.
II.	General Information
      EPA is proposing to designate PFOA and PFOS including their salts and structural isomers, as hazardous substances because evidence indicates that these chemicals may present substantial danger to public health or welfare or the environment when released into the environment. PFOA and PFOS are persistent and mobile in the environment, and exposure can lead to adverse human health effects, including high cholesterol, increased liver enzymes, decreased immune response to vaccination, thyroid disorders, pregnancy-induced hypertension and preeclampsia and cancer.
      PFOA and PFOS are common contaminants in the environment because of their release into the environment since the 1940s and their resistance to degradation. PFOA and PFOS are found in many environmental media and in wildlife worldwide.
      Environmental sources can include industrial discharge to soil, air, and water of PFOA and PFOS directly. PFOA and PFOS precursors can be converted to PFOA and PFOS, respectively, by microbes in soil, sludge, and wastewater and through abiotic chemical reactions. PFOA and PFOS that are deposited in a landfill or created by the degradation of their precursors in industrial and consumer waste can discharge via leachates, groundwater pollution/migration and atmospheric releases.
      The principal worldwide manufacturers of PFOA and PFOS and related chemicals phased out their production in the early 2000's although PFOA and PFOS may still be produced by international companies that import treated products to the United States. Environmental contamination and resulting human exposure to PFOS are anticipated to continue for the foreseeable future due to its environmental persistence, formation from precursor compounds, continued production by international manufacturers and as a result of the large legacy production in the United States.
      Per- and polyfluoroalkyl substances (PFAS) levels are found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean.
      PFOA and PFOS are widely detected in surface water samples collected from various rivers, lakes and streams in the United States.
      PFOA and PFOS have been detected in surface and subsurface soils.
      PFOA and PFOS have been detected in groundwater in monitoring wells, private drinking water wells, and public drinking water systems across the country.
      In addition to being found in the groundwater, surface water, soil, sediment, and air, they have been found in wild and domestic animals such as fish, shellfish, alligators, deer and avian eggs.
      The adverse human health effects, mobility, persistence, prevalence, and other factors related to these PFAS combine to result in EPA's proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to the public health or welfare or the environment.
      In addition to this action, in 2022, the EPA will be developing an advance notice of proposed rulemaking in which we will be seeking comments and data to assist in the development of potential future regulations pertaining to other PFAS under CERCLA.
 Does this action apply to me?
      The purpose of this proposed rulemaking is to designate PFOA and PFOS, including their salts and structural isomers, as hazardous substances under CERCLA section 102(a).  Upon designation, any person in charge of a vessel or an offshore or onshore facility that may have a release of such substances at or above the reportable quantity (RQ) must report such releases to the Federal, state, tribal and local authorities (CERCLA section 103(a), Emergency Planning and Community Right-to-Know Act (EPCRA) section 304).
B.	What are PFOA and PFOS?
      Since the 1940s, PFOA and PFOS have been used in hundreds of industrial applications such as fire-fighting foam and metal plating, and consumer products such as carpeting, apparel, upholstery and food paper wrappings. PFOA and PFOS are part of a large group of human-made, fluorinated, organic chemicals called PFAS. Manufacturers produce PFAS for a variety of industries and products, including surface treatments for soil/stain/water resistance and for specialized applications, such as fire suppression for flammable liquid fires.
      PFOA and PFOS have been produced within the U.S. as well as imported. PFOA and PFOS can also be formed by chemical or biological degradation from a large group of related PFAS (i.e., precursor compounds).[,] Their amphoteric nature has led to their use in a variety of consumer and industrial applications.
      Perfluoroalkyls, including PFOA and PFOS, exist as linear and branched isomers, depending on the methods by which they are produced. Both PFOA and PFOS were manufactured in numerous salt forms. In considering toxicity and fate and transport processes, the salts are deemed the same as the commonly referenced acid versions because, once added to water, the salts dissociate to the component ions (there are two ions, the cation and the anion). Hence, if any of the salt or acid forms of PFOA or PFOS are released into the environment, the anionic form will generally be found in environmental media; all references to PFOA and PFOS are meant to include all salts and structural isomers.
C.	Which entities are potentially affected by this action?
      The five broad categories of entities potentially affected by this action include: (1) PFOA and/or PFOS manufacturers; (2) PFOA and/or PFOS processors; (3) manufacturers of products containing PFOA and/or PFOS; (4) downstream product manufacturers and users of PFOA and/or PFOS products; and (5) waste management and wastewater treatment facilities. 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 action applies to them. Potentially affected entities may include:
                                  NAICS Code
List of potentially affected U.S. Industrial entities
327910
Abrasive product manufacturing
333999
All other miscellaneous general purpose machinery manufacturing
336111
Automobile manufacturing
488119
Aviation operations
314110
Carpet manufacturers
811192
Car washes
325
Chemical manufacturing
322813
Chrome electroplating, anodizing, and etching services
325510
Coatings, paints, and varnish manufacturers
325998
Fire-fighting foam manufacturers
562212
Landfills
423510
Metal service centers and other metal merchant wholesalers
922160
Municipal fire departments and firefighting training centers, including Federal agencies that use, trained with, and tested firefighting foams
424690
Other chemical and allied products merchant wholesalers
447190
Other gasoline stations
551112
Offices of other holding companies
322121 and 322130
Paper mills
324
Petroleum and coal product manufacturing
324110 and 424710
Petroleum refineries and terminals
352992
Photographic film manufacturers
325612
Polish, wax, and cleaning product manufacturers
325211
Polymer manufacturers
323111 and 325910
Printing facilities where inks are used in photolithography
334511
Search, detection, navigation, guidance, aeronautical, and nautical system and instrument manufacturing
313210, 313220,313230, 313240, and 313320
Textile mills (textiles and upholstery)
326113
Unlaminated plastics film and sheet (except packaging) manufacturing
562
Waste management and remediation services
221320
Wastewater treatment plants

D.	Are there liabilities associated with this proposed action?
      The designation of PFOA and PFOS, including their salts and structural isomers, as hazardous substances, if finalized, would result in a default RQ of one pound pursuant to CERCLA section 102. The failure to report releases at or above the RQ could result in penalties as provided in CERCLA section 103(b) and 109(a)(1)(A).
      Designation of a hazardous substance, by itself, is not sufficient to give rise to liability under CERCLA section 107(a). Like response actions, a party's potential liability is contingent upon a series of separate discretionary and sequential actions  -  such as filing of a lawsuit. Additionally, liability under CERCLA section 107 is established when the following four elements are met: (1) the site in question is a "facility" or "vessel" as defined by CERCLA section 101(9) and 101(28), respectively; (2) there was a "release" or threatened release of a "hazardous substance" at a facility or vessel, as defined in CERCLA sections 101(14) and 101(22); (3) a person is one of the four categories of responsible parties as set out in CERCLA section 107(a); and (4) the release or threatened release caused the incurrence of response costs.
      Even where potential liability exists, there are existing defenses to liability within CERCLA, and EPA has established policies that may provide some relief to stakeholders depending on fact-specific circumstances. The Agency intends to continue evaluating these issues during the comment period.
E.	What action is the Agency taking?
      The EPA is proposing to and requesting comment on designating PFOA and PFOS, including their salts and structural isomers, as hazardous substances under section 102(a) of CERCLA.
      The designation of PFOA and PFOS, including their salts and structural isomers, as hazardous substances, if finalized, would result in a default RQ of one pound pursuant to CERCLA section 102. CERCLA section 103(a) requires any person in charge of a vessel or facility, as soon as they have knowledge of any release (other than a federally permitted release) of a hazardous substance from such vessel or facility in quantities equal to or greater than the RQ (one pound) immediately notify the National Response Center (NRC) of such a release. The reporting requirements are further codified in 40 Code of Federal Regulations (CFR) 302.6(a). Section 304 of EPCRA (42 U.S.C. § 11004) also requires facility owners or operators to immediately notify their community emergency coordinator for local emergency planning committee (LEPC) (or tribal emergency planning committee (TEPC)), if established, for any area likely to be affected by the release and to the State Emergency Response Commission (SERC) (or Tribal Emergency Response Commission (TERC)) of any state or tribal region likely to be affected by the release. EPCRA section 304 also requires facilities to submit a follow-up written report to their SERC (or TERC) and the LEPC (or TEPC) as soon as practicable after the release. EPA published a guidance on July 13, 2010 (75 Federal Register (FR) 39852) defining the phrase, "as soon as practicable" to be 30 days after a release. (Note: Some states or tribes may require less than 30 days for submitting a follow-up report.) EPCRA section 304 requirements are codified in 40 CFR 355.30 to 355.43.
F.	What is the Agency's authority for taking this action?
      The legal authority for this action can be found in CERCLA section 102 (42 United States Code (U.S.C) section 9602), which gives the EPA Administrator authority to promulgate regulations designating as hazardous substances such elements, compounds, mixtures, solutions, and substances which, when released into the environment may present substantial danger to the public health or welfare or the environment.
G.	What are the incremental costs and benefits of this action?
       The EPA prepared an analysis of the potential costs and benefits associated with this action with respect to the reporting of any release of the subject hazardous substances. This analysis, Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as
 Hazardous Substances, is available in this action's docket. Due to uncertainty surrounding the number of annual releases, the EPA provides reporting cost estimates under lower bound and upper bound assumptions. The total reporting cost for a facility notifying the NRC, SERC (or TERC) and LEPC (or TEPC) by telephone with a follow-up written report to the SERC (or TERC) and LEPCs (or TEPCs), has been calculated to be approximately $561 per notification of a release, resulting in a maximum aggregate annual social cost of approximately $370,000 per year. Due to the lack of readily available, comprehensive data on the frequency of PFOA and PFOS releases, this analysis uses data from the NRC to estimate a range of possible average annual notifications.
       The NRC, managed by the U.S. Coast Guard, maintains a notification system for releases of oil and hazardous substances. In 2020, releases containing multiple forms of ammonia or ammonium compounds accounted for the largest number of releases, 660 in total. To develop an upper bound estimate of PFOA and PFOS release notifications, EPA adopts the high number of ammonia and ammonium release notifications of 660 per year.
      This rulemaking does not require the EPA to take response actions, does not require any response action by a private party and does not determine liability for hazardous substance release response costs. The direct obligations potentially triggered by the rulemaking, if finalized, are release reporting and notification requirements when federal agencies sell or transfer real property to any other person or entity to provide notice of the presence of hazardous substances in certain circumstances. The reporting obligation would arise for releases of these proposed hazardous substances (if finalized) that meet or exceed the RQ of one pound or more in a 24-hour period. Additional future costs may occur when federal agencies sell or transfer real property to any other person or entity with known presence of hazardous substances, as required by CERCLA section 120(h).
      Reporting does not trigger an obligation to conduct a response action. Response actions are discretionary, site-specific decisions made after the hazardous substance release or threatened release and are contingent upon a series of separate discretionary actions. Therefore, response costs for the designation of PFOA and PFOS as hazardous substances depend upon a number of steps removed from imposing costs on private entities. Since PFOA and PFOS may be considered pollutants or contaminants under CERCLA, EPA currently may choose to take action under EPA's CERCLA section 104(a) authority. (CERCLA Section 104(a) authorizes EPA to take a response action when "(A) any hazardous substance is released or there is a substantial threat of such a release into the environment, or (B) there is a release or substantial threat of release into the environment of any pollutant or contaminant which may present an imminent or substantial danger to the public health or welfare.") In addition, to the extent any releases of PFOA or PFOS are commingled with other hazardous substances at facilities or vessels, EPA may currently require the responsible party to address such releases.
      Future discretionary decisions about cleanup and response are difficult to quantify due to the uncertainties described below. While it is possible that release identification may contribute to investigations that reduce harm to human health, welfare and the environment, major uncertainties exist that prevent the development of reliable, relevant PFOA- and PFOS-related remediation cost estimates. Key among these limitations is uncertainty regarding: (1) how many sites have PFOA or PFOS contamination at a level that warrant a cleanup action; (2) the extent and type of PFOA and PFOS contamination at/near sites; (3) the extent and type of other contamination at/near sites; and (4) the incremental cost of assessing and remediating the PFOA and/or PFOS contamination at/near these sites.
      If this designation is finalized, EPA and other agencies exercising delegated CERCLA authority, could respond to these PFAS without making an imminent and substantial danger finding, could require the responsible party to address a release, and could seek contribution or recovery of costs incurred for their cleanup, assuming other relevant statutory criteria are met.
      The number of small entities in any sector where the owner or operator would be required to report, as a result of this action, is uncertain. However, the one-time reporting cost of $561, when compared with the average revenues for small entities in key sectors (1) PFOA and/or PFOS manufacturers, (2) PFOA and/or PFOS processors, (3) manufacturers of products containing PFOA and/or PFOS, (4) downstream product manufacturers and users of PFOA and/or PFOS products and (5) waste management and wastewater treatment facilities affected by PFOA and PFOS, does not exceed one percent of the average small-entity revenues in any sector. Therefore, the EPA is certifying under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) that the proposed rule would not have a significant impact on a substantial number of small entities.
      Additional future costs may occur when federal agencies sell or transfer real property to any other person or entity with known presence of hazardous substances, as required by CERCLA section 120(h). The number of future federal property transfers involving land contaminated with PFOA and/or PFOS is highly uncertain. Due to this uncertainty, this analysis does not attempt to quantify these costs.
      This action's qualitative benefits include improved quality of information and a more comprehensive understanding of the number and location of PFOA and PFOS releases meeting or exceeding the RQ. Other direct benefits could include better waste management and/or treatment practices for facilities handling PFOA or PFOS in order to avoid releases, which would require reporting. The reporting of a release could potentially accelerate privately financed voluntary cleanups and mitigate potential adverse impacts to human health and the environment.
III.	Background
      CERCLA establishes broad federal authority to respond to releases or substantial threats of releases of hazardous substances into the environment, or to releases or substantial threats of releases into the environment of any pollutant or contaminant which may present an imminent and substantial danger to the public health and welfare. The term "hazardous substance" is defined in section 101(14) of CERCLA primarily by reference to other environmental statutes and includes substances designated pursuant to CERCLA section 102.
      The EPA Administrator is authorized under CERCLA section 102(a) to promulgate regulations designating as a hazardous substance any such elements, compounds, mixtures, solutions, and substances which, when released into the environment, may present substantial danger to the public health or welfare or the environment. Because EPA has not previously exercised its authority under CERCLA section 102(a), it has not previously issued an interpretation of the standard for designating hazardous substances. EPA proposes to interpret "may present" in the statutory language as indicating that Congress did not require certainty that the substance presents a substantial danger or require proof of actual harm. In assessing whether a substance, when released, may present "substantial danger," the EPA proposes to consider factors such as the following: whether the substance has the potential to harm humans or the environment (i.e., hazard), and how the substance moves and degrades when in the environment (i.e., environmental fate and transport). To further inform its decision-making, the Agency proposes to also consider other factors that may be relevant when evaluating releases of the substance, such as the frequency, nature and geographic scope of previous releases of the substance. The Agency proposes to weigh these factors to determine whether the substance, when released, may present a "substantial danger."
      The scope of CERCLA section 102(a) is not limited to any specific facility, person or event. Rather, it necessitates consideration of whether a substance, when released into the environment may present substantial danger to public health or welfare or the environment. As a result, the designation process allows EPA to evaluate potential impacts from releases of candidate elements, compounds, mixtures, solutions, or substances based on scientific and technical information of sufficient quality (e.g., peer-reviewed and non-peer-reviewed (i.e., "grey literature") scientific literature), and other types of information (e.g., regulatory) from a wide range of sources that could include local, tribal, state, federal and international governments, as well as academia, non-profit organizations, and the private sector. For this proposed rulemaking, the Agency has found an aggregate amount of evidence supporting EPA's proposal to designate PFOA and PFOS as hazardous substances, which is described in detail in Section IV.C.
      The standard for CERCLA section 102(a) in this notice is based on the specific language and purpose of section 102(a) and does not affect EPA's interpretations of other CERCLA provisions containing similar language. See, e.g., CERCLA sections 104, 105, 106, 128. Those other provisions concern enforcement and response actions and apply to and require analyses of site-specific circumstances relevant to a particular facility or person, and to an event. As a result, the Agency assesses the particular situation at each site when it invokes those other authorities. By contrast, the statutory objectives associated with designating hazardous substances under CERCLA section 102(a) warrants a different implementation strategy because of its broader applicability and analytical requirements. These distinctions among statutory provisions with similar language are appropriate. The Supreme Court has held that statutory terms, even those that are defined in the statute, "may take on distinct characters from association with distinct statutory objects calling for different implementation strategies." Utility Air Regulatory Group v. EPA, 573 U.S. 302, 320 (2014) (quoting Environmental Defense v. Duke Energy Corp., 549 U.S. 561, 574 (2007)). See also Idaho Conservation League v. Wheeler, No. 18-1141, 2019 WL 3242390, at *4 (D.C. Cir. July 19, 2019) (quoting Weaver v. U.S. Info. Agency, 87 F.3d 1429, 1437 (D.C. Cir. 1996) ("[i]dentical words may have different meanings where `the subject-matter to which the words refer is not the same in the several places where they are used, or the conditions are different.'")
      All references to PFOA and PFOS in this notice are meant to include their salts and structural isomers (structural isomers have the same molecular formula but different carbon linking sequences).
IV.	Addition of PFOA, PFOS, and Their Salts and Structural Isomers, to List of Hazardous Substances
A.	Why is the EPA proposing to designate PFOA and PFOS as hazardous substances?
      The EPA is proposing to designate PFOA and PFOS as hazardous substances because an aggregate amount of evidence indicates that PFOA and PFOS may present substantial danger to public health or welfare or the environment when released into the environment.
      While EPA acknowledges that the science regarding PFOA and PFOS human health and environmental effects is still evolving, an aggregate body of scientific evidence shows that PFOA and PFOS are persistent and mobile in the environment, and that exposure to PFOA and PFOS can lead to adverse human health effects. This conclusion, supported by EPA's, other federal, state, tribal and international agencies', academia, non-profit and the private sector assessments warrant a hazardous substance designation based on the factors considered by EPA in this proposal, which, as noted above, included the potential human health or environmental hazards associated with exposure to PFOA and PFOS and the environmental fate and transport of PFOA and PFOS. The evidence for concern about PFOA and PFOS includes:
 Chemical/Physical Characteristics
 Toxicity and Toxicokinetics
 Environmental Prevalence
 Manufacturing and Use
 Regulatory and Advisory Status at EPA, Other Federal, State and International Agencies

      Each of the above evidence categories are discussed in more detail below. PFOA and PFOS hazardous substance designation would be consistent with and supportive of many EPA, other federal agencies, states, tribes and international bodies' actions. These entities have set PFOA and PFOS benchmarks and standards and have undertaken PFOA- and PFOS-based regulatory activities and enforcement actions. Details are provided below.
B.	What is the evidence for designation of PFOA and PFOS as hazardous substances?
      An aggregate collection of evidence and actions support designating PFOA and PFOS as hazardous substances under CERCLA section 102(a). EPA is proposing that, when released into the environment, PFOA and PFOS may present substantial danger to the public health or welfare or the environment. What follows are brief summaries and not a comprehensive review of the available literature.
a.	Chemical/Physical Characteristics. PFOA is comprised of eight carbons, seven of which are fully fluorinated, and the eighth carbon is part of a carboxylic acid group. PFOA is considered a surfactant (i.e., a substance that tends to reduce the surface tension of a liquid in which it is dissolved) due to its chemical structure consisting of a hydrophobic perfluorinated alkyl "tail group" and a hydrophilic carboxylate "head group".[,] As a result of the head group, PFOA is water soluble, which contributes to its tendency to be found in groundwater.
      PFOA is produced and used mainly as ammonium perfluorooctanoate (APFO), a salt of PFOA, that may include both linear and branched isomers. APFO's isomeric composition depends on the manufacturing processes used. The APFO that is produced through the perfluorooctyl iodide oxidation process, commonly called telomerization, is >99 percent linear, and the APFO that is produced by the electrochemical fluorination (ECF) process is >70 percent linear with the remaining <30 percent a mixture of branched isomers.[,] As a result, there are different PFOA structural isomers that may be released and found in the environment. Analytical chemistry methods used to detect and measure PFOA may measure the different isomers separately.
      PFOS has a fully fluorinated eight-carbon linear or branched tail, with a hydrophilic sulfonate functional head group attached to the carbon tail. PFOS is manufactured from perfluorooctanesulfonyl fluoride (POSF), which is produced through ECF. This process results in linear and branched isomers of PFOS. PFOS is often produced as its potassium salt. Like PFOA, PFOS is water soluble, which is why can be found in groundwater.
      As noted above, PFOA and PFOS contain carbon atoms bonded to fluorine atoms. These carbon-fluorine bonds are strong, causing PFOA and PFOS to be extremely resistant to degradation in the environment (including biodegradation, photolysis and hydrolysis) and, thus, likely to persist for long periods of time.[,]
PFOA and PFOS are well known to be persistent, bioaccumulate and toxic. PFOA and PFOS are distinctive because their water-solubility allows them to migrate readily from soil to groundwater. If PFOA and PFOS are released into the environment, they can contaminate surface water and groundwater used as drinking water sources, and persist for long periods of time, thereby posing a direct threat to human health and the environment. PFOA and PFOS have been measured in both sources of drinking water and treated drinking water.
These chemical and physical characteristics, and the aggregate evidence about them, amply support the EPA's proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to public health or welfare or the environment.
 Toxicity and Toxicokinetics. The following discussion is based on information and conclusions from the EPA 2016 Health Effects Support Documents for PFOA and PFOS and other published peer reviewed science. It does not reflect recent scientific data that has been collected to support EPA's ongoing PFAS National Primary Drinking Water Regulation. The Agency's draft new analyses, released in November 2021 for independent scientific review by the EPA Science Advisory Board (SAB), indicate that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is a likely carcinogen. The draft documents present EPA's initial analysis and findings with respect to this new updated available information.[,] Following SAB peer review, the final documents will be used to inform updated EPA drinking water health advisories and the development of Maximum Contaminant Level Goals and ultimately a National Primary Drinking Water Regulation for PFOA and PFOS.
      The weight of scientific evidence presented in the Health Effects Support Documents for PFOA and PFOS and supporting documents for the Regulatory Determination 4 process supports the conclusion that exposure to PFOA and PFOS can lead to adverse human health effects. As part of the final Regulatory Determination 4 process, the Agency concluded that PFOA and PFOS may have adverse health effects.
      Data from human and animal studies indicate that PFOA and PFOS are well absorbed via the oral route and are distributed throughout the body by noncovalent binding to serum albumin and other plasma proteins. PFOA and PFOS are slowly eliminated from the human body as evidenced by the half-life of 2.1-10.1 years for PFOA and 3.3-27 years for PFOS. Because of their resistance to metabolic degradation, PFOA and PFOS are eliminated from mammals primarily unchanged.
Human epidemiology studies demonstrate associations between PFOA exposure and high cholesterol, increased liver enzymes, decreased immune response to vaccination, thyroid disorders, pregnancy-induced hypertension and preeclampsia, and cancer (testicular and kidney). Epidemiology studies have generally found a positive association between increasing serum PFOA and total cholesterol levels in PFOA-exposed workers and residents of high-exposure communities. In addition, associations between increasing serum PFOA concentrations and elevations in serum levels of alanine aminotransferase and gamma-glutamyl transpeptidase were consistently observed in occupational cohorts, high-exposure communities and the U.S. general population. This could indicate the potential for PFOA to affect liver function. A decreased response to vaccines was found to be associated with PFOA exposure in studies in adults in a highly exposed community and in studies of children in the general population. A high-exposure community study reported an association between serum PFOA and risk of pregnancy-related hypertension or preeclampsia, conditions that are related to renal function during pregnancy. An association between increasing maternal PFOA or cord blood PFOA concentrations and decreasing birth weight was seen in several studies.
      Numerous epidemiology studies have examined occupational populations at large-scale PFOS production plants in the United States and the residential populations living near the PFOS production facilities to try to determine the association between increasing PFOS concentrations and various health outcomes. Data also suggest associations between higher PFOS levels and increases in total cholesterol and high-density lipoproteins, decreases in female fecundity and fertility, in addition to decreased offspring body weights and other measures of postnatal growth. Evidence for associations between PFOS exposure and cancer is less conclusive.
      Perfluoroalkyl acids are transferred to the fetus during pregnancy and to the nursing infant (i.e., distribution not excretion) and that can then lead to exposure in the fetus and nursing infant. Toxicity studies conducted in laboratory animal models demonstrate that the developing fetus is particularly sensitive to PFOA- and PFOS-induced toxicity. Some studies in laboratory animal models indicate that exposure during gestation and/or lactation are critical exposure windows that may lead to developmental health effects including decreased offspring survival, low birth weight, accelerated puberty and skeletal variations.[,][,]
      Numerous animal toxicity studies for PFOA and PFOS are available and can provide information about the potential for similar effects in humans. Animal studies and epidemiology studies indicate that PFOA and PFOS are well absorbed orally; absorption may also occur via the inhalation and dermal routes. Absorbed PFOA and/or PFOS are widely distributed in the body, with the highest concentrations typically found in the blood, liver and/or kidney. Across species, the highest extravascular concentrations of PFOA and PFOS are found in the liver, however, PFOA and/or PFOS have also been detected in many other tissues (e.g., lung, kidney, spleen and bone). Though not readily, PFOS can cross the blood-brain barrier and has been detected at low levels in the brains of humans and rodents.,,
      PFOA and PFOS in blood bind to plasma albumin and other plasma proteins. Absorbed PFOA and PFOS are not metabolized and are eliminated by excretion primarily in urine. Active transport mechanisms mediate renal tubular reabsorption and secretion of PFOA and PFOS. Some excretion occurs through cord blood in pregnant women, and through lactation and menstrual blood loss. Although PFOA and PFOS are found in the bile of humans, they are reabsorbed from the bile and thus, fecal excretion is substantially lower than urinary excretion; levels in fecal matter represent both unabsorbed material and that discharged with bile.[,][,][,][,]
      For PFOA, oral studies of short-term (subchronic) and chronic duration are available in multiple species including monkeys, rats and mice. The animal studies report developmental effects, liver and kidney toxicity, immune effects and cancer (liver, testicular and pancreatic). The developmental effects observed include decreased survival, delayed eye opening, reduced ossification, skeletal defects, altered puberty (delayed vaginal opening in females and accelerated puberty in males) and altered mammary gland development. In animal studies, changes in relative and/or absolute liver weight with or without other hepatic indicators of adversity were observed.
      For PFOS, numerous animal studies are available in multiple species including monkeys, rats and mice. Short-term and chronic exposure studies in animals demonstrate increases in liver weight, decreased cholesterol, hepatic steatosis, lower body weight and liver histopathological changes. One- and two- generation rodent toxicity studies also show decreased pup survival and body weights. Additionally, developmental neurotoxicity studies in rodents show increased motor activity, decreased habituation and increased escape latency in the water maze test following in utero and lactational exposure to PFOS. Gestational and lactational exposures were also associated with higher serum glucose levels and evidence of insulin resistance in adult offspring. Evidence suggests immunological effects in animal models.,
      The International Agency for Research on Cancer (IARC) concluded that PFOA is possibly carcinogenic to humans. While study findings are mixed, a mutagenic mode of action for PFOA or PFOS has not been established. Studies do indicate that PFOA (the more extensively studied of the two compounds) can induce deoxyribonucleic acid damage. The EPA determined there was suggestive evidence for PFOA and PFOS to contribute to tumor development in humans.[,] Epidemiology studies show an association of serum PFOA with testicular and kidney cancer in
highly exposed humans; two chronic bioassays in rats[,] also support the finding that PFOA is tumorigenic. Epidemiology studies correlating PFOS exposure and the incidence of carcinogenicity are limited; however, a chronic toxicity and carcinogenicity study in rats provides some evidence of tumorigenicity.
      In sum, studies have shown that exposure to PFOA and PFOS is associated with numerous and varied adverse effects to human. This evidence plays a major role in the EPA's proposed rule to designate PFOA and PFOS as hazardous substances.
      c.	Environmental Prevalence. PFOA and PFOS are common contaminants in the environment because of their release into the environment since the 1940s and their resistance to degradation. PFOA and PFOS are found in many environmental media and in wildlife worldwide, including in remote polar regions. As an example, the polar bear, the top predator of arctic marine ecosystems, bioaccumulates high concentrations of PFAS (especially PFOS), which may be harmful to their health.
   Environmental sources can include industrial discharge to soil, air, and water of PFOA and PFOS directly. Precursors can also degrade to PFOA and/or PFOS (e.g., perfluorooctanesulfonamide (PFOSA) can be transformed to PFOS in the environment). PFOA and PFOS precursors can be converted to PFOA and PFOS, respectively, by microbes in soil, sludge, and wastewater and through abiotic chemical reactions. PFOA and PFOS that are deposited in a landfill or created by the degradation of their precursors in industrial and consumer waste can discharge via leachates, groundwater pollution/migration and atmospheric releases.,, The discharge of aqueous film-forming foam (AFFF) is also an important source for some locations. AFFF is a foam containing many PFAS compounds, including PFOA and PFOS, which is effective at extinguishing high-hazard liquid fires. PFAS, including PFOA and PFOS, were found in the soil and groundwater where AFFF was used to fight fires or for training and storage. Concrete where AFFF has been repeatedly discharged, such as for training activities, can absorb PFAS and then release PFAS to groundwater and soils during precipitation events. Biosolids from wastewater treatment plants and some industrial wastewater that is land applied is also a potential source of contamination.,
      Industrial uses that have led to PFOA and PFOS in the soil and groundwater include, but are not limited to, chrome plating facilities where PFAS was used as a wetting agent/fume suppressant and industries where textiles and other materials are coated with PFAS. PFAS manufactured for use as a stain or water repellant may be released from these facilities into the air and wastewater.
      The principal worldwide manufacturer of PFOA and PFOS and related chemicals phased out their production in the early 2000's. PFOA and PFOS may still be produced by international companies that import treated products to the United States. Some uses of PFOS are ongoing. Environmental contamination and resulting human exposure to PFOS are anticipated to continue for the foreseeable future due to its environmental persistence, formation from precursor compounds, continued production by international manufacturers and as a result of the large legacy production in the United States.
      Wastewater treatment plants (WWTPs) may receive wastewater that contains PFOA, PFOS or their precursors, from a variety of sources, including industries that manufacture or use these PFAS and their precursors. Some companies may operate onsite wastewater treatment facilities, but typically they are not designed to remove PFAS. PFOA and PFOS are the most widely detected PFAS compounds in wastewater, and generally treatment units at conventional WWTPs do not remove PFAS
efficiently. Certain PFAS can be volatilized into the atmosphere from wastewater treatment plant operations, such as aeration chambers.[,] Although effluent discharged to receiving water bodies may contain PFOA or PFOS, much of it may concentrate in the WWTP biosolids. Biosolids are also commonly applied to land as fertilizers or soil amendments but can also be sent to a landfill. The use of biosolids on farmland and home gardens can lead to the uptake of PFOA and PFOS in the food chain, as acknowledged by the U.S. Food and Drug Administration (FDA).
      PFAS levels are found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean. Concentrations are not generally correlated with rural or urban environments, but rather, around PFAS production industries and industries that use PFAS. Mean PFOA levels ranged from 1.54 to 15.2 picograms per cubic meter (pg/m[3]) in air samples collected in the urban locations in Albany, New York, Fukuchiyama, Japan, and Morioka, Japan and in the rural locations in Kjeller, Norway, and Mace Head, Ireland. However, higher mean concentrations (101 - 552 pg/m[3]) were measured at the urban locations in Oyamazaki, Japan, and Manchester, United Kingdom (UK), and semirural locations in Hazelrigg, UK. Maximum reported concentrations at Oyamazaki and Hazelrigg were 919 and 828 pg/m[3], respectively. Thus, there is not a correlation between concentrations and urban versus rural locations, but rather specific locations with high concentrations that may be attributable to a specific industrial plant.
      PFOA and PFOS are widely detected in surface water samples collected from various rivers, lakes and streams in the United States. The presence of PFOA and PFOS in surface water in the United States indicates that systems using these contaminated source waters may face challenges treating and removing these chemicals from their finished drinking water where appropriate. The most vulnerable drinking water systems are those in close proximity to sites contaminated with PFOA and PFOS. Levels of these substances in surface water appear to be declining since the major U.S. producers phased out these two substances.
      PFOA and PFOS have been detected in surface and subsurface soils. Levels of PFOA and PFOS generally increased with increasing depth at sampled locations, suggesting a downward movement of the contaminants and the potential to contaminate groundwater. PFAS can be inadvertently released to soils when biosolids are applied as fertilizer to help maintain productive agricultural soils and stimulate plant growth. PFOA and PFOS have been detected in both biosolids and biosolid-amended soils. PFAS can also reach soil due to atmospheric transport and wet/dry deposition.
      PFOA and PFOS have been detected in groundwater in monitoring wells, private drinking water wells, and public drinking water systems across the country. The EPA worked with the states and local communities to monitor for six PFAS chemicals, including PFOA and PFOS, under the third Unregulated Contaminant Monitoring Rule to understand the nationwide occurrence of these chemicals in the U.S. drinking water provided by public water systems (PWSs). Of the total PWSs with results for PFOA and PFOS (4920), 117 PWSs detected PFOA above the minimum reporting level (minimum reporting level = 20 nanogram/liter (ng/L)). The number of PWSs with detections above the MRLs for PFOS (MRL = 40 ng/L) was 95.
      As previously stated, PFOA and PFOS are common contaminants in the environment because they and their precursors have been produced and released into the environment since the 1940s, and they are resistant to degradation. In addition to being found in the groundwater, surface water, soil, sediment, and air, they have been found in wild and domestic animals such as fish, shellfish, alligators, deer and avian eggs. As examples, PFOA has also been found in snack foods, vegetables, meat, dairy products and fish, and PFOS has been found in eggs, milk, meat, fish and root vegetables.,,,,,,,,, In one study investigating the global distribution of PFAS, wildlife samples were collected on four continents including North America and Antarctica. Wildlife sampled included marine mammals, birds, and polar bears. Only a few samples contained PFOA in concentrations greater than the limit of quantification. However, over 30 different species had measurable levels of PFOS. The study reported PFOS concentrations in mink liver in the midwestern U.S. ranging from 970-3680 nanograms per gram (ng/g), river otter liver in northwestern U.S. from 34-990 ng/g, brown pelican liver in Mississippi from 290-620 ng/g, and lake whitefish eggs in Michigan waters from 150-380 ng/g.,
      PFOS bioaccumulates in animals. A fish kinetic bioconcentration factor for PFOS has been estimated to range from 1000 to 4000. The time to reach 50% clearance of PFOS in fish has been estimated to be around 100 days. Bioaccumulation has been demonstrated for fish, birds, crustaceans, worms, plankton, and alligators, among others.[,][,]
      The prevalence of PFOA and PFOS in environmental media, wild animals, livestock, and plants not only affects the environment but can also lead to human exposure. PFOA and PFOS can also enter the drinking water supply from contamination in groundwater and surface water sources for drinking water. Contaminated drinking water or groundwater can also be used to irrigate or wash home-grown foods or farm-grown foods, thereby providing another means for human exposure. Wild animals are contaminated through environmental exposure, and some wild animals are caught or hunted and eaten by humans, thus, increasing human exposure. Contaminated water also results in the contamination of beef, pork, poultry, etc. Susceptible populations, such as women of reproductive age, pregnant and breastfeeding women, and young children who eat fish may increase exposure due to PFOA and PFOS due to bioaccumulation in fish.,,
      Taken together, this information illustrates the prevalence of PFOA and PFOS in water, soil, air, plants, and animals worldwide due to its transportability and persistence. This widespread distribution of these PFAS significantly contributes to the EPA's proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to the public health or welfare or the environment. Further, human exposure is confirmed by measurements of PFOA and PFOS that were detected in human serum as part of the continuous National Health and Nutrition Examination Survey (NHANES), a program of the Centers for Disease Control and Prevention (CDC). PFOA and PFOS were measured in the serum of a representative sample of the U.S. population ages 12 years and older in each two-year cycle of NHANES since 1999  -  2000, with the exception of 2001  -  2002. PFOA and PFOS have been detected in 99% of those surveyed in each NHANES cycle. However, the mean concentrations of PFOA and PFOS in the serum have been steadily decreasing since 1999  -  2000.,
      d.	Manufacturing and Use. As mentioned earlier in this document, manufacturers produce PFAS for a variety of industries and products, including surface treatments for soil/stain/water resistance; surface treatments of textiles, paper, metals; and for specialized applications, such as fire suppression for flammable liquid fires. There are many situations that can lead to PFAS being found in manufactured goods and the environment, including:
 PFAS can be found in food if it is packaged in PFAS-containing materials (e.g., sandwich wrappers and food/juice containers), processed with equipment that used PFAS, or grown in PFAS-contaminated soil or water.
 Certain PFAS may be found in commercial household products, including stain- and water-repellent fabrics, nonstick products, polishes, waxes, paints and cleaning products.
 PFAS may be found in the environment from fire-fighting foams. This is a considerable source of groundwater and surface water contamination at airports, military bases and other facilities where foam was used for firefighting training, incident response or where foam was stored.
 PFAS may be found in the environment from manufacturing facilities, production facilities or industries, for example, chrome plating, electronics manufacturing, textile manufacturing or oil recovery.
 PFAS that has been released to the environment may be found in drinking water, typically because of localized contamination associated with a specific facility (e.g., manufacturer, landfill, wastewater treatment plant, firefighter training facility).
 PFAS that has been released in the environment may also be found in living organisms, including plants, animals and humans due to the above-mentioned sources.
      The most common processes for making fluorinated chemicals are ECF and telomerization. Production sites that were located in the U.S. including (Decatur, Alabama), Belgium (Zwijndrecht near Antwerp) and Miteni (Northern Italy) produced PFAS by means of ECF.  Examples of industrial applications of PFOA and PFOS are or were:
 Formerly used as an additive in AFFF extinguishing foams, however, these are being actively replaced by PFOS-free extinguishing foams.
 Used in plating processes as a wetting agent/fume suppressant.
 Used to provide resistance to grease, oil and water in various industrial and consumer applications, such as cardboard, paper (including food packaging applications), carpets, textiles, leather and non-stick pans (polytetrafluoroethylene).
 Used as processing aids in fluoropolymer production.
 Used as processing aids in textile coating applications.
 Used in insecticides.
 Used as certain types of adhesives.
 Used in industrial and consumer cleaning products such as carpet cleaners, auto washes and electronics.
 Used in various types of coating products, paints, varnishes and inks.
 Used as surfactants for oil extraction and mining.
 Used as photo lithography, photographic coatings and hydraulic fluids for aviation.[,]
 Used in explosives, munitions, and pyrotechnics as binders and oxidizers.
      Although PFOA and PFOS production may be ending in the United States, its continued use in certain applications and persistence in the environment means that its historical production and use will continue to be a concern in the future.
      Domestic production and import of PFOA has been phased out in the United States by the companies participating in the 2010/2015 PFOA Stewardship Program. PFOA may be produced, imported, and used by companies not participating in the PFOA Stewardship. The EPA Chemical Data Reporting rule under the Toxic Substance Control Act (TSCA) requires manufacturers (including importers) to report PFOA and PFOS quantities if they meet or exceed 2,500 lbs at a single site. The last time PFOA and PFOS manufacturing information was reported to EPA as part of this collection effort was in 2013 and 2002, respectively. However, the 2020 TRI data shows that PFOA and PFOS are released into the environment.
      These facts further support the EPA's proposed finding that PFOA and PFOS, when released into the environment may present substantial danger to the public health or welfare or environment.
e.	Regulatory and Advisory Status at EPA, Other Federal, State and International Agencies.
Regulatory requirements, enforcement actions, and other activities of many federal, state, and international entities together indicate the widespread and serious concern with PFOA and PFOS. These steps, which have been taken by numerous, credible organizations to address PFOA and PFOS, further support and are consistent with designating PFOA and PFOS as CERCLA hazardous substances.
      i. EPA Actions. The EPA has taken several actions in the past to address risks from PFOA and PFOS. In 2006, the EPA launched the 2010/2015 PFOA Stewardship Program, under which eight major chemical manufacturers and processors agreed to phase out the use of PFOA and PFOA-related chemicals in their products and emissions from their facilities. All companies met the PFOA Stewardship Program goals by 2015.
      The TSCA program has taken a range of regulatory actions to address PFAS substances in manufacturing and consumer products. Since 2002, EPA has finalized a number of TSCA Section 5(a) Significant New Use Rules (SNURs) covering hundreds of existing PFAS chemical substances no longer in use. These regulatory actions require notice to EPA, as well as Agency review and regulation, as necessary, before manufacture (including import) or processing for significant new uses of these chemicals can begin or resume. The SNURs also apply to imported articles containing certain PFAS, including consumer products such as carpets, furniture, electronics, and household appliances. EPA also has issued SNURs for dozens of PFAS chemical substances that have undergone EPA's new chemicals review prior to commercialization; these actions ensure that any new uses which may present risk concerns but were not part of the EPA new chemicals review, do not commence unless EPA is notified, conducts a risk review, and regulates as appropriate under TSCA section 5.
      In 2016, the EPA issued lifetime health advisories (LHAs) of 70 parts per trillion (ppt) (ng/L) for PFOA and PFOS in drinking water. The EPA's health advisories are non-enforceable and non-regulatory and provide technical information to state agencies and other public health officials on health effects, analytical methodologies, and treatment technologies associated with drinking water contamination. When both PFOA and PFOS are found in drinking water, the individual or combined concentrations of PFOA and PFOS should be compared with the 70 ppt health advisory level. The EPA recommends that these LHAs apply to both short-term (i.e., weeks to months) scenarios, such as during pregnancy and lactation, as well for lifetime exposure scenarios.[,] As previously mentioned, in November 2021, EPA released new health effects analyses for PFOA and PFOS for independent scientific review by the Agency's Science Advisory Board. The Agency has committed to moving as quickly as possible to issue updated health advisories for PFOA and PFOS that reflect this new science and input from the Science Advisory Board.
      In 2019, EPA issued the Interim Recommendations to Address Groundwater Contaminated with PFOA and PFOS to facilitate cleaning up contaminated groundwater that is a current or potential source of drinking water. The recommendations provide a starting point for making site-specific cleanup decisions. The guidance recommends:
 Using a screening level of 40 ppt to determine if PFOA and/or PFOS is present at a site and may warrant further attention.
 Screening levels are risk-based values that are used to determine if levels of contamination may warrant further investigation at a site.
 Using EPA's PFOA and PFOS LHA level of 70 ppt as the preliminary remediation goal (PRG) for contaminated groundwater that is a current or potential source of drinking water, where no state or tribal maximum contaminant level (MCL) or other applicable or relevant and appropriate requirements are available or sufficiently protective.
 PRGs are generally initial targets for cleanup that may be adjusted on a site-specific basis as more information becomes available.
      In 2020, the EPA issued a final rule strengthening the regulation of PFAS (i.e., PFOA and its salts, long-chain perfluoroalkyl carboxylate chemical substances) by requiring notice and EPA review before the use of long-chain PFAS that have been phased out in the United States could begin again. Additionally, products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances can no longer be imported into the United States without EPA review. This action means that articles like textiles, carpet, furniture, electronics, and household appliances that could contain certain PFAS chemicals cannot be imported into the United States unless EPA reviews and approves the use or puts in place the necessary restrictions to address any unreasonable risks.
      In 2020, the EPA also added 172 PFAS (including PFOA and PFOS) to the TRI and 3 additional compounds were added in 2021. Additional PFAS will continue to be added to TRI, consistent with the National Defense Authorization Act for Fiscal Year 2020.
      In October 2021, the EPA released the PFAS Strategic Roadmap that presents EPA's whole-of-agency approach to addressing PFAS and sets timelines by which the Agency plans to take concrete actions. Several actions described in the roadmap, including this proposed rule, address PFOA and PFOS. Other ongoing EPA actions on PFOA and PFOS include:
 Finalizing a proposed rule that would collect certain information on PFAS, including PFOA and PFOS, manufactured at any time since January 1, 2011 (86 FR 33926).
 Finalizing the proposed Unregulated Contaminant Monitoring Rule 5 (UCMR5). As proposed, UCMR5 would collect data on 29 PFAS, including PFOA and PFOS, in public water systems (86 FR 13846).
 Establishing a national primary drinking water regulation for PFOA and PFOS under the Safe Drinking Water Act.
 Publishing recommended aquatic life water quality criteria for PFOA and PFOS and developing human health water quality criteria for PFOA and PFOS.
 Finalizing a risk assessment for PFOA and PFOS in biosolids, which will serve as the basis for determining whether regulation of PFOA and PFOS in biosolids is appropriate.
      Further, based on public health and environmental protection concerns, and in response to a petition from the Governor of New Mexico, which requested EPA to take regulatory action on PFAS under the Resource Conservation and Recovery Act (RCRA), EPA announced on October 26, 2021, the initiation of two rulemakings. First, EPA will initiate the rulemaking process to propose adding four PFAS chemicals as RCRA hazardous constituents under 40 CFR Part 261 Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS chemicals EPA will evaluate are: PFOA, PFOS, perfluorobutane sulfonic acid (PFBS) and GenX. Second, EPA will initiate a rulemaking to clarify in the Agency's regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA section 1004(5). This modification would clarify that emerging contaminants such as PFAS can be addressed through RCRA corrective action.
      Recent scientific data and the Agency's new analyses indicate that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood and that PFOA is a likely carcinogen. The Agency's new analyses were released in November 2021 for independent scientific review by the EPA Science Advisory Board. The draft documents present EPA's initial analysis and findings with respect to this new information. Following peer review, this information will be used to inform updated EPA drinking water health advisories and the development of Maximum Contaminant Level Goals and a National Primary Drinking Water Regulation for PFOA and PFOS.
      ii. Actions by Other Federal Agencies. The Agency for Toxic Substances and Disease Registry (ATSDR), in response to a congressional mandate under CERCLA, develops comparison values to help identify chemicals that may be of concern at hazardous waste sites. The ATSDR's guideline values are minimal risk levels (MRLs). An MRL is an estimate of the amount of a chemical a person can eat, drink, or breathe each day over a specified duration without a detectable risk to health. MRLs are developed for health effects other than cancer. If someone is exposed to an amount above the MRLs, it does not mean that health problems will happen. When health professionals find exposures higher than the MRL, it means that they may want to look more closely at a given case. The ATSDR works closely with EPA at both a national and regional level to identify actual or potential releases where exposures are estimated to exceed health-based values such as MRLs. The ATSDR has final intermediate duration MRLs (2021) for PFOA and PFOS which are 3x10[-6] milligram/kilogram/day (mg/kg/day) and 2x10[-6] mg/kg/day, respectively.
      The DoD included PFOA and PFOS on its list of emerging contaminants. The DoD defines emerging contaminants as chemicals or materials that the department currently uses or plans to use that present a potentially unacceptable human health or environmental risk; have a reasonably possible pathway to enter the environment; and either do not have regulatory standards based on peer-reviewed science, or their regulatory standards are evolving due to new science, detection capabilities or exposure pathways.
      In 2017, the DoD edited their military specification for AFFF to include no more than 800 parts per billion, the quantitation limit by DoD Quality Systems Manual 5.1, of PFOA and PFOS in the concentrate. The DoD is working to remove AFFF containing PFOA and PFOS from the supply chain. "In January 2016, the Office of the Assistant Secretary of Defense for Energy, Installations and Environment issued a policy requiring the DoD components to: 1) issue Military Service-specific risk management procedures to prevent uncontrolled land-based releases of AFFF during maintenance, testing and training activities, and 2) remove and properly dispose of AFFF containing PFOS from the local stored supplies for non-shipboard use to prevent future environmental
      response action costs, where practical". Under this policy, the Air Force funded the removal of AFFF from all fire trucks and crash response vehicles and replaced it with PFOS-free AFFF, which contains only trace quantities of PFOA. All Air Force bases except Thule Air Force Base, Greenland, have received replacement AFFF, and 97 percent of the bases have completed the transition. In addition, the Navy is updating the military specification requirements for AFFF and working with manufacturers to determine the exact chemical composition of AFFF alternatives. DoD has also set up a taskforce to address PFAS contamination on and near military bases
      DoD is investing over $49 million through fiscal year 2025 in research, development, testing, and evaluation in collaboration with academia and industry to identify alternative firefighting material and practices. In the meantime, DoD only uses AFFF to respond to emergency events and no longer uses it for land-based testing and training.
      In addition, DoD has initiated other actions to test for, investigate, and mitigate elevated levels of PFOA and PFOS at or near installations across the military departments. Following the release of EPA's LHAs for PFOA and PFOS in May 2016, each of the military departments issued guidance directing installations to test for PFOA and PFOS in their drinking water and take steps to address drinking water that contained amounts of PFOA and PFOS above EPA's health advisory level. The military departments also directed their installations to identify locations with a known or suspected prior release of PFOA and PFOS and to address any releases that pose a risk to human health. As of September 2020, the DoD was assessing PFAS at over 600 facilities. As of August 2017, the DoD sampled over 2,400 off-base public and private drinking water systems for PFAS. Of those systems sampled, 564 public or private drinking water systems had PFOA and PFOS at levels above the EPA LHA. The DoD also initiated actions to address PFOA and PFOS in drinking water both on military installations and outside military installations.
      On January 17, 2019, the Federal Aviation Administration (FAA) released guidance in the form of a CertAlert to all certificated Part 139 Aircraft Rescue and Firefighting departments regarding safer methods for the required bi-annual testing of AFFF for firefighting. In the guidance, the FAA suggests alternative AFFF testing systems that minimize environmental impact while still satisfying the regulatory requirement for safety testing. The recommendations include addressing environmental concerns such as establishing safe and environmentally effective handling and disposal procedures.
      On October 4, 2021, the FAA published a CertAlert which informs Part 139 airport operators about changes to the military specification (MIL-PRF-24385F(SH)) for firefighting foam referenced in Chapter 6 of AC No.: 150/5210-6D. While the performance standard remains the same, the military specification no longer requires the use of fluorinated chemicals. One acceptable means of satisfying 14 CFR Part 139 requirements is to continue to use the existing approved foam which does contain fluorinated chemicals. However, FAA encourages certificate holders that have identified a different foam that meets the performance standard to seek approval for such foam from the FAA.
      iii. State Actions. As concerns have arisen regarding PFOA and PFOS many states have taken regulatory action.
      In addition to some of the states discussed in more detail below, Alabama, Arizona, Idaho, Kentucky, Nebraska and West Virginia have opted to use EPA's LHAs of 70 ppt for PFOA and PFOS.[,][,][,]
      The Alaska Department of Environmental Conservation (ADEC) promulgated groundwater cleanup levels of 400 ppt and soil cleanup levels of 1.3 to 2.2 milligram per kilogram (mg/kg) (range depending on precipitation zone) for PFOA and PFOS, respectively, in Oil and Other Hazardous Substances Pollution Control Regulations as amended through June 2021. Health-based action levels for drinking water of 70 ppt for PFOA and PFOS, individually or combined, were established by ADEC in 2018 (updated in 2019) based on EPA's LHAs.
      In August 2019, the California Office of Environmental Health Hazard Assessment developed PFOA and PFOS toxicity values (acceptable daily doses) of 4.5 x 10[-7] mg/kg-day and 1.8 x 10[-6] mg/kg-day, respectively, and reference levels based on cancer effects of 0.1 ppt and 0.4 ppt, respectively. They noted that the levels are lower than the levels of PFOA and PFOS that can be reliably detected in drinking water using currently available technologies. Thus, they recommended that the State Water Resources Control Board set notification limits at the lowest levels at which PFOA and PFOS can be reliably detected in drinking water using available and appropriate technologies. The California State Water Resources Control Board issued new drinking water notification limits for local water agencies to follow for finding and reporting PFOA and PFOS of 5.1 ppt for PFOA and 6.5 ppt for PFOS. As part of these guidelines, California also established a response level of 10 ppt for PFOA and 40 ppt for PFOS.[,] If this level is exceeded in drinking water provided to consumers, California recommends that the water agency remove the water source from service.
      In July 2021, the California Office of Environmental Health Hazard Assessment released draft Public Health Goals (PHGs) for PFOA of 0.007 ppt based on human kidney cancer data and PFOS of 1 ppt based on liver and pancreatic tumor animal data. PHGs are not
      regulatory requirements and are based solely on protection of public health without regard to cost impacts or other factors.
      California is also conducting sampling efforts targeting airports, chrome plating facilities, landfills, WWTPs and nearby water supply wells.
      To address known contamination in El Paso County, the Colorado Water Quality Control Commission (WQCC) adopted a site-specific groundwater quality standard of 70 ppt for PFOA and PFOS combined in 2018 based on the EPA LHAs.[,] By 2019, the Colorado Department of Public Health and Environment adopted a PFAS Action Plan outlining methods by which the state planned to protect residents from PFAS. As part of this initiative, a survey was conducted regarding the use of firefighting foams that resulted in rules with respect to the registration and use of PFAS-containing
      foams. The Colorado WQCC approved a policy interpreting the existing narrative standards for PFAS in 2020. This policy outlines the use of translation levels of 70 ppt for PFOA, PFOS, PFOA and PFOS parent constituents, and perfluorononanoic acid (PFNA), individually or combined, based on the EPA's LHAs.
       Connecticut has issued a drinking water action level of 70 ppt for PFOA, PFOS, PFNA, perfluorohexanesulfonic acid (PFHxS) and perfluoroheptanoic acid (PFHpA) individually or combined. The action level is based on risk and similar health effects of the five PFAS. An interagency task force was formed that has recommended actions including take-back and safe disposal of AFFF containing PFAS from state and municipal fire departments.
       Based on Delaware's Department of Natural Resources and Environmental Control Hazardous Substance Cleaning Act Screening Level Table Guidance (last updated in November 2021), a screening/reporting level for PFOA and PFOS, individually or combined, of 70 ppt in groundwater is based on EPA's LHAs; and a reporting/screening level for PFOA and PFOS in the soil (of 0.13 mg/kg based on screening document and 1.3 mg/kg based on the reporting level table) is based on EPA's Regional Screening Level Calculator.[,]
       Florida issued guidance identifying provisional groundwater target cleanup levels of 70 ppt for PFOA and PFOS combined, provisional soil cleanup target levels of 1.3 mg/kg for PFOA and PFOS, and surface water screening levels of 500 ppt for PFOA and 10 ppt for PFOS; these values were last updated in 2020.
       In 2020, Hawaii published a memorandum identifying interim soil and water and soil environmental action levels (EALs) for PFAS. For groundwater that is a current potential source of drinking water, groundwater EALs are 40 ppt for PFOA and PFOS and soil EALs are 0.0012 mg/kg for PFOA and 0.0075 mg/kg for PFOS. For the protection of groundwater quality, 40 ppt is identified as the final groundwater action level.
       By July 2021, Illinois EPA issued statewide health advisories for six PFAS: PFOA, PFOS, PFNA, perfluorohexanoic acid (PFHxA), PFHxS and PFBS. A health advisory is a regulatory action that provides guidance to local officials and community water supply operators in protecting the health of their customers. Illinois EPA is authorized to issue a health advisory when there is a confirmed detection in a community water supply well of a chemical substance for which no numeric groundwater standard exists. The health-based guidance level for PFOA is 2 ppt and PFOS is 14 ppt. Illinois EPA is conducting a statewide investigation into the prevalence and occurrence of PFAS in finished water at entry points to the distribution system representing 1,749 community water supplies across Illinois.
       The Iowa Department of Natural Resources issued Statewide Standards for PFOA and PFOS in 2016.  The standards were set at 70 ppt for PFOA and PFOS for a protected groundwater source, and 50,000 ppt for PFOA and 1000 ppt for PFOS for a non-protected groundwater source. Statewide standards for soil are 35 mg/kg for PFOA and 1.8 mg/kg for PFOS.
       The Kansas Department of Health and Environment, the Bureau of Environmental Remediation, and the Bureau of Water are working together to address PFAS in drinking water. The process involves the development of a statewide inventory and prioritization of potential PFAS sources. This information will be used to develop a public water supply monitoring program.
       Maine's Department of Environmental Protection requires the testing of all sludge material licensed for land application in the state for PFAS (including PFOA and PFOS). The governor created a task force to mobilize state agencies and other stakeholders to review the prevalence of PFAS in Maine. Maine Remedial Action Guidelines (RAGs) for Sites Contaminated with Hazardous Substances (2018) identified a water RAG of 400 ppt for PFOA and PFOS and a soils (residential) RAG of 1.7 mg/kg for PFOA and PFOS. In June 2021, the Governor also signed an emergency resolution establishing an interim drinking water standard of 20 ppt for 6 PFAS. The resolution also requires that the Maine Department of Health and Human Services promulgate an MCL for PFAS by June 1, 2024.
      In December 2019, the Massachusetts Department of Environmental Protection Office of Research and Standards reassessed the toxicity information for a subgroup of longer chain PFAS. They applied a revised RfD of 5 x 10[-6] mg/kg-day to PFOA, PFOS, PFNA, PFHxS, PFHpA and perfluorodecanoic acid (PFDA). This reassessment resulted in an MCL of 20 ppt, promulgated in October 2020.[,] Also, PFAS are considered to be hazardous material subject to the notification, assessment and cleanup requirements of the Massachusetts Waste Site Cleanup Program.
       Michigan derived a toxicity value of 3.9 x 10[-6] mg/kg-day for PFOA and 2.89 x 10[-6] mg/kg-day for PFOS. Michigan's public health drinking water MCLs are 8 ppt for PFOA and 16 ppt for PFOS, effective in August 2020. The Michigan PFAS Action Response Team has coordinated many actions across the state. Michigan Department of Health and Human Services has recommended people avoid contaminant-induced foam occurring on certain PFAS-contaminated surface water bodies and has initiated a PFAS Exposure and Health Study. The Michigan Department of Environment, Great Lakes, and Energy began a statewide initiative to test drinking water from all community water supplies for PFAS and has been testing watersheds. Do not eat advisories have also been issued for deer, fish, and other wildlife in certain parts of the state.[,][,][,][,][,]
       Minnesota's Department of Health (MDH) identified reference doses (RfDs) of 1.8 x 10[-5] mg/kg-day for PFOA, adopted as Rule in August 2018 and 3.1 x 10[-6] mg/kg-day for PFOS, adopted as Rule in August 2020. MDH developed guidance values in drinking water of 35 ppt for PFOA and 15 ppt PFOS. The MDH is helping with drinking water well testing in certain areas of the state. Due to PFAS contamination in surface water bodies and levels of PFOS found in fish, the MDH has issued fish advisories for certain surface water bodies. Minnesota's Pollution Control Agency Toxics Reduction and Pollution Prevention program is working to reduce PFAS in firefighting foam, chrome plating, and food packaging, with related efforts in state and local government purchasing.
       The Montana Department of Environmental Quality set a Groundwater Quality Standard for PFOA and PFOS, individually or combined, of 70 ppt in 2019.
       The Nevada Division of Environmental Protection identified basic comparison level values of 667 ppt for PFOA and PFOS in residential water and 1.56 mg/kg in residential soil. Exceedance of a basic comparison level does not automatically trigger a response action but warrants further evaluation of health risks.
      New Hampshire's Department of Environmental Services recommended RfDs of 6.1 x 10[-6] mg/kg-day and 3.0 x 10[-6] mg/kg-day
      for PFOA and PFOS, respectively, in June 2019. New Hampshire has undertaken sampling for PFAS at water supplies, wastewater treatment plants, fire stations, landfills and contaminated waste sites to better understand the scope of contamination in the state. The New Hampshire Department of Environmental Services filed and finalized its rulemaking to establish MCLs for PFOA of 12 ppt and PFOS of 15 ppt, as well as 11 ppt for PFNA and 18 ppt for PFHxS. The MCLs initially became effective on September 30, 2019. However, on December 31, 2019, the Merrimack County Superior Court issued a preliminary injunction barring enforcement of the MCLs. The New Hampshire legislature subsequently amended the New Hampshire Safe Drinking Water Act in July 2020 establishing the 4 PFAS MCLs.
      The New Jersey Department of Environmental Protection (NJDEP) identified RfDs of 2 x 10[-6] mg/kg-day for PFOA and 1.8 x 10-6 mg/kg-day for PFOS.[,] On June 1, 2020, the NJDEP published a health based MCL for PFOA of 14 ppt and an MCL for PFOS of 13 ppt in the New Jersey Register. New Jersey previously adopted an MCL for PFNA of 13 ppt on September 4, 2018. New Jersey uses a risk assessment approach to protect for chronic drinking water exposure when setting MCLs. The NJDEP also adopted these same levels as formal groundwater quality standards for the purposes of site remediation activities and discharges to groundwater. New Jersey has added PFNA, PFOA and PFOS to its hazardous substances list.
      New Mexico Environment Department issued Risk Assessment Guidance for Site Investigations and Remediation that identified preliminary screening levels of 70 ppt for PFOA, PFOS, and PFHxS, individually or combined, in drinking water and 1.56 mg/kg for PFOA, PFOS, and PFHxS in residential soil in 2019.
      New York regulates PFOA and PFOS as hazardous substances. New York finalized regulations in 2017 that specify storage and registration requirements for Class B firefighting foams containing at least one percent by volume of one or more of four PFAS (including PFOA and PFOS) and prohibits the release of one pound or more of each into the environment during use. If a release meets or exceeds the one-pound threshold, it is considered a hazardous waste spill and must be reported, and cleanup may be required under the state's Superfund or Brownfields programs. In August 2020, New York adopted MCLs of 10 ppt for both PFOA and PFOS.[,]
      North Carolina's Department of Environmental Quality determined an Interim Maximum Allowable Concentration for groundwater of 2000 ppt for PFOA (table last updated in June 2021).
      The Ohio Environmental Protection Agency and Ohio Department of Health released a Polyfluoroalkyl Substances Action Plan for Drinking Water in 2019. Objectives included gathering sampling data, providing private water system owners with guidelines and resources to identify and respond to PFAS contamination, identifying resources to assist public water systems in the implementation of preventative and long-term measures to reduce PFAS-related risks, increasing awareness of PFAS and associated risks, ongoing engagement, and establishing Action Levels for drinking water systems in Ohio that are protective for human health. As part of this initiative, Ohio indicated that Action Levels of 70 ppt for PFOA and PFOS, singly or combined, would be established.
      The Oregon Department of Environmental Quality set initiation levels (ILs) for PFOA and PFOS of 24,000 ppt and 300,000 ppt, respectively (last amended in 2019). The rule indicated that ILs referred to concentrations in effluent, that, if exceeded, requires preparation of a pollutant reduction plan.[,]
      The Pennsylvania Department of Environmental Protection (PADEP) adopted a medium-specific concentration of 70 ppt in groundwater for PFOA and PFOS, individually or combined, based on EPA's LHAs in 2016. MSCs are 4.4 mg/kg for PFOA and PFOS in residential soil. PADEP has proposed rulemaking to incorporate groundwater and soil cleanup standards for PFOA, PFOS, and PFBS, and has initiated the process to set drinking water MCLs for PFOA and PFOS.
      The Rhode Island Department of Environmental Management (RIDEM) set Groundwater Quality Standards for PFOA and PFOS, individually or combined, of 70 ppt. RIDEM indicated that EPA's LHAs are used to determine the response to protect human health when
      these substances are detected in groundwater known or presumed to be suitable for drinking water use without treatment.
      Texas has developed toxicity factors for PFOA and PFOS (using appropriate adjustments and uncertainty factors) for use at remediation sites. When combined with reasonable maximum long-term exposure assumptions for standard receptors (e.g., residents, commercial/industrial workers) and multiple simultaneous routes of exposure (e.g., incidental soil ingestion, dermal exposure), the Texas Commission on Environmental Quality believes these toxicity factors (e.g., RfDs) will result in sufficiently protective environmental media (e.g., soil) cleanup concentrations based on available data. Texas's RfDs for PFOA and PFOS are 1.2x10[-05] and 2.3x10[-05] mg/kg/day, respectively. Tier 1 Protective Concentration Level (PCL) tables, released in January 2021, identified PCLs of 290 ppt for PFOA and 560 ppt for PFOS. PCLs are the default cleanup standards in the Texas Reduction Program.
       Vermont's drinking water health advisory is 20 ppt for a combination of five (PFOA, PFOS, PFHxS, PFHpA and PFNA) compounds based on a combined risk assessment. Vermont has issued final rules amending a number of regulations pertaining to groundwater to set cleanup levels of 20 ppt for PFOA, PFOS, PFHxS, PFHpA and PFNA. These rules became effective on July 6, 2019. Vermont passed a law in 2019 requiring public water systems to monitor for PFAS.[,] It also directed the Agency of Natural Resources to potentially regulate PFAS and report on various monitoring activities.
      Washington is developing rule language to establish proposed state action levels (SALs) of 10 ppt for PFOA and 15 ppt for PFOS (also levels for 3 other PFAS). SALs are levels set for long-term daily drinking water to protect human health; systems that exceed SALs would be required to notify their customers.
      Wisconsin identified a toxicity value (acceptable daily intake) of 2 x 10[-6] mg/kg-day for PFOA and recommended the ATSDR value of 2 x 10[-6] mg/kg-day for PFOS. The Wisconsin Department of Health Services has sent to Wisconsin Department of Natural Resources recommended groundwater standards of 20 ppt for PFOA and PFOS individually and combined. The Wisconsin PFAS Action Council has developed statewide initiatives to address PFAS in Wisconsin. The council led the development of a comprehensive Wisconsin PFAS Action Plan that will serve as a roadmap for how state agencies will address these emerging chemicals.
      iv. Enforcement. Enforcement actions, both by states and EPA, have been taken to mitigate risks from PFOA and PFOS. To date, EPA has addressed PFAS in 16 cases using a variety of enforcement tools under the Safe Drinking Water Act (SDWA), TSCA, RCRA, and CERCLA, as well as overseeing PFAS response actions by federal agencies at National Priorities List sites. Designating PFOA and PFOS as CERCLA hazardous substances will allow EPA to use its CERCLA enforcement authorities, in appropriate circumstances and where relevant statutory elements are met, which could allow a shift of the cost-burden of response activities from the taxpayers/fund to potentially responsible parties.
      For example, in 2002 the EPA entered into an emergency administrative order on consent under SDWA with E. I. du Pont de Nemours and Company. DuPont agreed to provide alternative drinking water or treatment for public or private water users living near the Washington Works facility in Washington, West Virginia, if the level of PFOA detected in their drinking water was greater than the PFOA screening level established by a C-8 Assessment of Toxicity team. The C-8 Assessment team was formed pursuant to a state order and established the screening level for PFOA at 150,000 ppt. In 2006, after the science on health effects of PFOA evolved, the EPA entered into a second emergency administrative order under SDWA with DuPont that replaced the 2002 order and established a site-specific action level equal to or greater than 500 ppt.
      In 2009, after EPA scientists established a provisional health advisory for PFOA of 400 ppt to address short-term exposure to PFOA, EPA entered into a third emergency administrative order under the SDWA with DuPont that replaced the 2006 order and lowered the allowable concentration of PFOA in drinking water from 500 ppt to 400 ppt in communities near the facility. The provisional health advisory for PFOA was based on available science at that time.
      In 2017, EPA issued an amendment to the 2009 emergency administrative order with DuPont by adding The Chemours Company as a respondent and lowering the allowable concentration of PFOA in drinking water from 400 ppt to 70 ppt in communities near the facility. The amendment, issued on May 19, 2016, was based upon current science, changed circumstances, site-specific information, and EPA's health advisories for PFOA and PFOS.
      v. International Actions. PFAS, including PFOA and PFOS, are subject to international treaties and individual country regulations on their production, use, and release to the environment.
      PFOA is identified by the United Nations Environment Programme (UNEP) as "a substance of very high concern with a persistent, bioaccumulative and toxic structure for the environment and living organisms" and is listed under Annex A of the Stockholm convention.
      In November 2017, the Persistent Organic Pollutants Review Committee adopted a risk management evaluation for PFOA, its salts and PFOA-related compounds, defined as "any substances that degrade to PFOA, including any substances (including salts and polymers) having a linear or branched perfluoroheptyl group with the moiety (C7F15)C as one of the structural elements, for example: (i) Polymers with >=C8 based perfluoroalkyl side chains; 8:2 fluorotelomer compounds; and (iii) 10:2 fluorotelomer compounds".[,] In 2019, at the 9[th] Conference of Parties (COP-9) meeting, the Stockholm Convention agreed to a global ban on PFOA and some related compounds for criteria including health effects such as kidney cancer, testicular cancer, thyroid disease, ulcerative colitis and pregnancy-induced hypertension. This action also included five-year exemptions for use in semiconductor manufacturing, firefighting foams, worker-safety textiles, photographic coatings for films and medical devices. While a signatory to the Stockholm Convention, the U.S. has not ratified and is therefore not a Party to the convention however, additional exemptions were requested by China, Iran and the European Union.
      PFOS, along with its salts and precursor POSF have been classified as a persistent, highly bioaccumulative organic pollutant and listed under Annex B of the Stockholm Convention. At the 2009 Stockholm Convention COP-4 meeting, parties to the convention restricted PFOS production and use, but also included exemptions. The 2019 COP-9 meeting tightened PFOA and PFOS restrictions, but left an exemption for the pesticide sulfluramid, which is known to degrade into PFOS and PFOA.[,] This pesticide is no longer registered for use in the United States.
      The European Union (EU) has taken steps to regulate PFOA, its salts and related substances in a wide range of products. PFOA and APFO are also required to be classified, labelled, and packaged under regulation EC No 1272/2008 and there is a ban on placing these chemicals on the market as substances, constituents of other substances, or in mixtures for supply to the general public. PFNA and PFDA have been proposed for similar classification and labelling by Sweden.
      In July 2020, the European Food Safety Authority modified its 2018 decision to set safety levels for PFOA and PFOS to include PFNA and PFHxS, based on their observed human bioaccumulation and toxicity. A combined safety threshold or group tolerable weekly limit in food and water of 4.4 nanograms/kilogram of body weight was set for these four PFAS.
      Because there are thousands of PFAS widespread in the environment and substance-by-substance risk assessments, environmental monitoring and regulation would be extremely lengthy and resource-intensive, an alternative approach has been proposed to regulate PFAS as a class, or as subgroups, based on toxicity or chemical similarities. The agreement by the European Parliament and the Council in December 2019 on the recast of the Drinking Water Directive includes a limit of 0.5 micrograms per liter for all PFAS. In December 2020, the European Parliament formally adopted the revised Drinking Water Directive. Based on the widespread occurrence of PFAS in the environment and their risk properties, in June 2019 the European Council of Ministers called for an action plan to eliminate all non-essential uses of PFAS.
      A number of countries have issued standards and guidance values for PFOA, PFOS, and other PFAS individually or cumulatively. These are summarized below.
      Australia and New Zealand  -  The Food Standards Australia New Zealand (FSANZ), a statutory authority in the Australian Government health portfolio, and the National Medical Research Council have developed health-based guidance values for PFOA, PFOS, and PFHxS for exposure from food, drinking water and recreational water. The guidance values give tolerable daily intake (TDI) for lifetime exposure levels from food or drinking water that will not result in significant risk to human health. Based on the TDI, FSANZ's recommended tolerable daily intake and issued drinking water and recreational water guideline values for use in site investigations in Australia. TDI were derived from animal studies and pharmacokinetic modeling used to extrapolate to humans. For PFHxS, FSANZ concluded that the available data were insufficient to develop a TDI and that the PFOS TDI should be applied to PFHxS and a combined concentration of PFOS plus PFHxS should be used to evaluate exposure.
                          Health based guidance value
                               Total PFOS+PFHxS
                                     PFOA
                            Tolerable daily intake
                  (nanograms/kilogram of body weight per day)
                                      20
                                      160
                    Drinking water quality guideline value
                             (nanograms per liter)
                                      70
                                      560
                  Recreational water quality guideline value
                             (nanograms per liter)
                                     2,000
                                    10,000

      Canada - PFOA, its salts and precursors, as well as long-chain perfluorocarboxylic acids, their salts and precursors were assessed in 2012. These substances are prohibited for import and use with a limited number of exemptions under the Prohibition of Certain Toxic Substances Regulations, 2012. In 2018 additional proposed amendments to the Canadian Environmental Protection Act, 1999, to regulate additional PFAS were postponed to late 2021. The proposed amendments include PFOS, its salts and precursors that contain one of the following groups: C8F17SO2, C8F17SO3 or C8F17SO2N (PFOS), PFOA and its salts and precursors. It also includes all longer chain perfluorocarboxylic acids having the molecular formula CnF2n+1CO2H in which 8 <= n <= 20, their salts and precursors.[,]
      Guidelines for Canadian Drinking Water Quality set the maximum acceptable concentration (MAC) for PFOA in drinking water at 200 ppt and PFOS in drinking water at 600 ppt. These MACs are based on exposure to individual chemicals. Because the toxicological effects of PFOA and PFOS are additive they should be evaluated together, and the ratio of the observed concentration for PFOS to its MAC plus the ratio of the observed concentration for PFOA to its MAC should be below 1 for drinking water to considered safe.[,] For other PFAS with a more limited database, drinking water screening values were developed.
      Peoples Republic of China - The "Industrial Recon-structuring Guide Directory" restricted the production of PFOS and PFOA. In 2014, the Ministry of Environmental Protection announcement No. [2014]21, banned "production, transportation, application, imports and exports of PFOS, its salts, and POSF, except for specific exemptions and acceptable use."
      Denmark - Based on toxicity the Danish Environmental Protection Agency has identified health-based criteria or limit values for drinking water, groundwater used for drinking water and soil. Drinking water and groundwater used for drinking water criteria or limit values for PFOS and/or PFOSA (a PFOS precursor) are 100 nanograms per liter and PFOA of 300 nanograms per liter. For cumulative exposure the ratio of the sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should be below 1.
      The health-based criteria or limit value for soil is 390 micrograms per kilogram for PFOS and PFOSA and 1,300 micrograms per kilogram for PFOA and its salts. Cumulatively the sum of concentration/limit value ratios for PFOA, PFOS and PFOSA should be below 1.
      The Danish Ministry of the Environment and Food - Denmark banned food contact paper and cardboard in which per and polyfluoro chemicals, including PFOA and PFOS and their salts and precursors, have been used unless they incorporate a barrier to prevent migration into food.
      Japan - In 2010 Japan designated PFOS, its salts, and POSF as Class I Specified Chemical Substances following their addition to the Stockholm Convention on Persistent to Organic Pollutants Annex B. Regulating manufacture, use, export and import of PFOA and its salts.
      Norway - Norway listed PFOA and PFOS on its national list of priority substances based on monitoring data that showed high levels of these substances in the environment as well as their toxicological profiles. In 2014, Norway banned manufacturing, production, import and retail of consumer products containing PFOA.
      f.	Conclusion. EPA's proposal to designate PFOA and PFOS, and their salts and structural isomers, as hazardous substances under CERCLA section 102(a) is based on the aggregate evidence, summarized above, that indicates, when released into the environment, these substances may present substantial danger to the public health, welfare or the environment. Collectively, this information demonstrates that PFOA and PFOS should be designated as hazardous substances under CERCLA.
V.	Effect of Designation
A.	Default Reportable Quantity
	Section 102(b) of CERCLA provides that, until superseded by regulation, the reportable quantity for any hazardous substance is one pound. This proposed rule does not include an RQ adjustment for PFOA and/or PFOS. EPA is setting the RQ by operation of law at the statutory default of one pound pursuant to Section 102(b) of CERCLA. If the Agency chooses to propose changing the RQ in the future, it would do so through notice-and-comment rulemaking.
B.	Reporting and Notification Requirements for CERCLA Hazardous Substances
Section 103 of CERCLA requires any person in charge of a vessel or facility to immediately notify the NRC when there is a release of a hazardous substance, as defined under CERCLA section 101(14), in an amount equal to or greater than the RQ for that substance. The reporting requirements are further codified in 40 CFR 302.6. If this action is finalized, any person in charge of a vessel or facility as soon as he or she has knowledge of a release from such vessel or facility of one pound or more of PFOA and/or PFOS in a 24-hour period is required to immediately notify the NRC in accordance with 40 CFR part 302.
      In addition to these CERCLA reporting requirements, EPCRA section 304 also requires owners or operators of facilities to immediately notify their SERC (or TERC) and LEPC (or TEPC) when there is a release of a CERCLA hazardous substance in an amount equal to or greater than the RQ for that substance within a 24-hour period. EPCRA section 304 requires these facilities to submit a follow-up written report to the SERC (or TERC) and LEPC (or TEPC) within 30 days of the release. (Note: Some states require less than 30 days to submit the follow-up written report. Facilities are encouraged to contact your state or tribal agency for additional reporting requirements.) See 40 CFR part 355, subpart C, for information on the contents for the initial telephone notification and the follow-up written report.
      EPCRA and CERCLA are separate, but interrelated, environmental laws that work together to provide emergency release notifications to federal, state, tribal, and local officials. Notice given to the NRC under CERCLA serves to inform the federal government of a release so that federal personnel can evaluate the need for a response in accordance with the National Oil and Hazardous Substances Contingency Plan, the federal government's framework for responding to both oil and hazardous substance releases. The NRC maintains all reports of hazardous substance and oil releases made to the federal government.
      Relatedly, release notifications under EPCRA given to the SERC (or TERC) and to the LEPC (or TEPC) are crucial so that these state, tribal, and local authorities have information to help protect the community.
      Under section 104 of CERCLA, the federal government may respond whenever there is a release or a substantial threat of a release of a hazardous substance into the environment. CERCLA section 104 response authority is delegated to the EPA and other select federal agencies under Executive Order No. 12580 (52 FR 2923, January 23, 1987) and Executive Order No. 13016 (61 FR 45,871, August 28 ,1996).
C.	Effect of This Rulemaking
      A hazardous substance release notification is a trigger for informing the government of a release so that appropriate federal personnel can evaluate what, if any, federal action should be taken. Federal personnel evaluate all reported releases, but do not initiate a removal or remedial action in response to all reported releases. The RQ of a hazardous substance does not represent a determination that releases of that quantity will necessarily be harmful to public health or welfare or the environment. Thus, government personnel assess each reported release on a case-by-case basis to determine what, if any, federal response action should be taken (40 CFR part 300 and 33 CFR part 153).
      Section 103(a) of CERCLA requires releases of hazardous substances (other than federally permitted releases) that equal or exceed RQs to be immediately reported to the NRC. (See 67 FR 18899, April 17, 2002.)
      Two obligations are potentially triggered by this rulemaking, if finalized. These obligations are the reporting of a release of PFOA or PFOS that meets or exceeds the RQ of one pound in a 24-hour period and the CERCLA Section 120(h) obligation to provide notice when federal agencies transfer property and the covenants. Reporting does not trigger an obligation for EPA, or anyone else, to conduct a response action. Response actions are contingent upon a series of separate discretionary and sequential actions; they do not arise directly from the act of designating PFOA and PFOS as hazardous substances under CERCLA.
VI.	Statutory and Executive Order Reviews
      Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A.	Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
      This action is a significant regulatory action that was submitted to the OMB for review. The action may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Any changes made in response to the OMB recommendations have been documented in the docket. The EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis, Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances is available in the docket for this action.
B.	Paperwork Reduction Act
      The information collection activities in this proposed rule have been submitted for approval to the OMB under the Paperwork Reduction Act. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2708.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
      Under Section 102(a) of CERCLA, EPA is proposing to designate PFOA and PFOS, including their salts and structural isomers, as hazardous substances.
      If finalized, the designation of PFOA and PFOS, and their salts and structural isomers, as hazardous substances would require any person in charge of a vessel or facility that identifies a release of one pound or more within a 24-hour period of these substances to report the release to the NRC under section 103 of CERCLA and to the SERC (or TERC) and LEPC (or TEPC) under section 304 of EPCRA. The implementing regulations of CERCLA section 103 and EPCRA section 304 are codified at 40 CFR parts 302 and 355, respectively.
Respondents/affected entities: Any person in charge of a vessel or facility from which there is a release of PFOA or PFOS and their salts and structural isomers, equal to or greater than the RQ of one pound within 24 hours.
Respondent's obligation to respond: Mandatory under section 103 of CERCLA and section 304 of EPCRA.
Estimated number of respondents: From 0 to 660 releases per year.
Frequency of response: Varies.
Total estimated burden: 6415 hours (per year) maximum. Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $370,000 (per year) maximum, includes $3,503 annualized operation and maintenance costs (and no capital costs).
      An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR 9.
      Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to<EMAIL_ADDRESS>Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. The EPA will respond to any ICR-related comments in the final rule.
C.	Regulatory Flexibility Act (RFA)
      I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are: (1) producers and importers of PFOA and PFOS, (2) producers and users of PFOA or PFOS-containing articles, and (3) waste management and wastewater facilities. The Agency has estimated that there may be up to 660 reported releases of PFOA or PFOS in any one year and that an indeterminate number, but small percentage, of the annual reports will be submitted by small entities.  The estimated cost of $561 to report a release of PFOA or PFOS is not greater than 1% of the annual revenues per small entity in any impacted industry. Details of this analysis are presented in Assessment of the Potential Costs and Other Impacts of the Proposed Rulemaking to Designate Perfluorooctanoic Acid and Perfluorooctanesulfonic Acid as Hazardous Substances. We have therefore concluded that this action will not have a significant regulatory burden for all directly regulated small entities.
D.	Unfunded Mandates Reform Act (UMRA)
      This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531 - 1538, and does not significantly or uniquely affect small governments. This action is expected to result in reporting costs of $561 per release that meets or exceeds the RQ, and the estimated annual cost of the proposed rule is not expected to exceed $370,000 per year.
E.	Executive Order 13132: Federalism
      This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
F.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
      This action does not have tribal implications as specified in Executive Order 13175 because it does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. EPA does not expect that it would result in any adverse impacts on tribal entities. Thus, Executive Order 13175 does not apply to this action.
      Consistent with the EPA Policy on Consultation with Indian Tribes, the EPA intends to consult with and request comments from tribal officials.
G.	Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
      This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866. This action, which proposes to designate PFOA and PFOS as hazardous substances, does not itself address environmental health or safety risks. Beyond the requirements of EO 13045, EPA's 2021 Policy on Children's Health (October 5, 2021) requires EPA to consistently and explicitly consider early life exposures and lifelong health in all human health decisions. The EPA believes that the environmental health or safety risk posed by exposure to PFOA and/or PFOS may have a disproportionate effect on children. A discussion of health and risk assessments related to PFOA and PFOS, including developmental and reproductive health effects, are contained in EPA's Health Effects Support Documents for PFOA and PFOS (2016).
H.	Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
      This action is not a "significant energy action" because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This action proposes to designate PFOA and PFOS as hazardous substances, and thus, does not involve the supply, distribution or use of energy.
I.	National Technology Transfer and Advancement Act
      This action does not involve technical standards.
J.	Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
      The EPA is unable to determine if this action does or does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
      Several key demographic categories were analyzed relative to facilities with known historical use and/or releases of PFOA and PFOS. Because the location of future releases of PFAS is uncertain, this analysis considers populations around facilities in sectors associated with widespread historical uses and releases of PFAS as proxies for facilities that may have future releases of the PFAS considered in the proposed rule. This analysis examines the following site types as proxies for facilities that are known to have commonly used PFAS:
             Operating Department of Defense (DOD) facilities
             Operating U.S. airports and airfields
             Plastics material and resin manufacturing firms identified as having produced PFOS and/or PFOA,
             2020 PFOS and PFOA releases reported to EPA's Toxic Release Inventory (TRI)
      On average, airports across the U.S. are surrounded by populations that reflect national averages in relevant demographic categories. Large airports, however, are more likely to be surrounded by minority and low-income populations than medium or small airports. Some DOD sites are surrounded by populations with higher concentrations of minority and low-income residents, but the majority of these sites are below the national averages for these metrics. In contrast, areas around plastics material and resin manufacturer sites and/or sites reporting releases to TRI, on average, are in areas with higher concentrations of minority residents and households experiencing poverty than the U.S. averages for these demographics, suggesting that releases related to manufacturing facilities could have environmental justice implications.  A complete discussion of the analysis behind these findings is available in Section 4.3 of the regulatory impact analysis accompanying this rulemaking. These findings, combined with the uncertainty surrounding the location of future releases, are indicative of potential impacts but do not provide a clear indication of the type of disparities related to potential exposure to PFAS. Consistent with the priorities outlined in Executive Orders 12898 and 14008, it is unclear whether this proposed regulation will have a significant impact on disadvantaged populations or communities with environmental justice (EJ) concerns relative to other communities. While the locations that may report releases are unknown, to the extent that these proxy locations are representative of likely reporting locations, this screening analysis suggests that the reporting required under the rule may provide better information to nearby populations potentially at risk of exposure, including communities with EJ concerns. Because releases reported to TRI mostly involve disposal or manufacturing sites, demographic data around plastics material and resin manufacturer sites and historical releases may be a more reliable predictor of the type of community potentially affected by this proposed rulemaking.  Specific site conditions and demographic patterns may become clear as reporting occurs following completion of a final rule. Once available, this information would improve EPA's ability to examine disparate impacts on EJ communities. This improved information would not increase risk for communities with EJ concerns and may improve the speed and design of remediation.  EPA is committed to minimizing and/or eliminating existing barriers and burdens that communities with EJ concerns may encounter related to accessing data and information collected as a result of this rulemaking, if finalized. EPA seeks comment on strategies to improve access to the reporting data expected to be collected, if designation of PFOA and PFOS as hazardous substances is finalized, for communities with environmental justice concerns.
      Further, the documentation for this decision is contained in the following sections in the preamble to this action: I.E. What are this action's costs and benefits?; II. Background; and IV.B. Reporting and Notification Requirements for CERCLA Hazardous Substances. These sections explain that the designation of PFOA and PFOS as hazardous substances, if finalized, and the required reporting and notification requirements, will result in more information about the location and extent of releases. This improved information does not increase risk or result in any adverse environmental justice impacts.

List of Subjects in 40 CFR Part 302
      Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.

Dated: __________________________________.

________________________________________
Michael S. Regan,
Administrator.
      For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 302 as follows:
PART 302  - DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION:
1. The authority citation for part 302 continues to read as follows:
      Authority: 33 U.S.C. 1251 et. seq., 42 U.S.C. 9601, 42 U.S.C. 9602, 42 U.S.C. 9603
§ 302.4 Designation of hazardous substances.
2. In § 302.4:
a.	Table 302.4 -- List of Hazardous Substances and Reportable Quantities is amended by listing the following new entries:
       Table 302.4 -- List of Hazardous Substances and Reportable Quantities
          [Note: All Comments/Notes Are Located at the End of This Table]

                                Hazardous Substance

                                       CASRN
                                 Statutory
code†
                                  RCRA
waste
No.
                               Final RQ
pounds (Kg)
        Perfluorooctanesulfonic acid, & salts, & structural isomers
                                     1763-23-1
                                         5

                                     1 (0.454)
           Perfluorooctanoic acid, & salts, & structural isomers
                                     335-67-1
                                         5

                                     1 (0.454)

b.	The Notes section is amended to read as follows:
Note: The numbers under the column headed "CASRN" are the Chemical Abstracts Service Registry Numbers for each hazardous substance. The "Statutory Code" column indicates the statutory source for designating each substance as a CERCLA hazardous substance: "1" indicates that the statutory source is section 311(b)(2) of the Clean Water Act, "2" indicates that the source is section 307(a) of the Clean Water Act, "3" indicates that the source is section 112 of the Clean Air Act, "4" indicates that the source is section 3001 of RCRA, and "5" indicates that the source is section 102(a) of CERCLA. The "RCRA Waste Number" column provides the waste identification numbers assigned to various substances by RCRA regulations. The "Pounds (kg)" column provides the reportable quantity adjustment for each hazardous substance in pounds and kilograms.
c.	Appendix A to § 302.4 -- List of Hazardous Substances and Reportable Quantities is amended by adding the following new entries in alphabetical order:
    Appendix A to §302.4  --  List of Hazardous Substances and Reportable Quantities is amended by adding the following new entries in alphabetical order:

Hazardous Substance
CASRN
Statutory code†
RCRA waste No.
Final RQ pounds (Kg)
        Perfluorooctanesulfonic acid, & salts, & structural isomers
                                      1763231
                                         5

                                    ## (0.454)
           Perfluorooctanoic acid, & salts, & structural isomers
                                      335671
                                         5

                                    ## (0.454)