Risk Management for Per- and Polyfluoroalkyl Substances (PFAS) under TSCA
Overview of PFAS Actions under TSCA
PFAS are a group of man-made chemicals that includes perfluorooctanoic acid (PFOA), perfluorooctyl sulfonate (PFOS), GenX and many other chemicals. Examples of where PFAS can be found include cleaners, textiles, leather, paper and paints, fire-fighting foams, and wire insulation. Certain PFAS can accumulate and stay in the human body for long periods of time. There is evidence that exposure to PFAS can lead to adverse health outcomes in humans. Get basic information on what PFAS are, where they are found, and other EPA actions.
EPA has taken a range of regulatory actions to address PFAS substances in manufacturing and consumer products as noted below. EPA’s New Chemicals program reviews alternatives for PFOA and related chemicals before they enter the marketplace to identify whether the range of toxicity, fate and bioaccumulation issues that have caused past concerns with perfluorinated substances may be present in order to ensure that the new chemicals may not present an unreasonable risk to health or the environment. In addition, EPA developed and industry implemented a global stewardship program with the goal of eliminating these chemicals from emissions and products by 2015.
- On September 30, 2024, EPA requested public comment on the manufacture of PFAS, including PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulation under the Toxics Substances Control Act (TSCA). This request for public comment follows the Agency’s July 2024 grant of a petition to address PFAS formed during the fluorination of plastic containers.
- On July 10, 2024, EPA granted a petition from the Center for Environmental Health, Public Employees for Environmental Responsibility, Alaska Community Action on Toxics, Clean Cape Fear, Clean Water Action, Delaware Riverkeeper and Merrimack Citizens for Clean Water to address PFAS formed during the fluorination of plastic containers – PFOA, PFNA and PFDA. These PFAS have been found in plastic containers used for a variety of household consumer, pesticide, fuel, automotive and other industrial products. By granting this petition, EPA stated that it will promptly commence an appropriate proceeding under TSCA Section 6.
- In January 2024, EPA finalized a significant new use rule (SNUR) that strengthens the regulation of PFAS by preventing anyone from resuming manufacture or processing of inactive PFAS without EPA review of the significant new use. Inactive PFAS are PFAS chemical substances that have not been manufactured (including imported) or processed for many years. This rule reflects the Biden-Harris Administration’s commitment to address the impacts of these forever chemicals, and is a key action in EPA’s PFAS Strategic Roadmap. The SNUR applies to PFAS that are listed as “Inactive” on the TSCA Inventory and are not already subject to a SNUR. This “Inactive” designation means that a chemical substance has not been manufactured (including imported) or processed in the United States since June 21, 2006. The effective date of the rule is 60 days after publication, after which anyone wishing to manufacture or process any of the 329 PFAS is now required to seek EPA review of the activity by submitting a Significant New Use Notice (SNUN) to EPA and complying with any applicable requirements resulting from such review. Read the rule.
- In December 2023, EPA issued orders to Inhance Technologies LLC directing it not to produce PFAS, chemicals that are created in the production of its fluorinated HDPE plastic containers. This action, taken under the authority of TSCA, will help protect the public from exposure to dangerous PFAS chemicals in containers used for a variety of household consumer, pesticide, fuel, automotive and other industrial products.
- In March 2022, EPA provided information to manufacturers (including importers), processors, distributors, users, and those that dispose of fluorinated HDPE containers and similar plastics (i.e., fluorinated polyolefins) about the potential for PFAS to form and migrate from these items. EPA was made aware of and determined via testing in March 2021 that certain PFAS have formed and migrated from these items. EPA issued an open letter to: (1) raise awareness to industry of this issue in order to help prevent unintended PFAS formation and contamination and (2) outline the requirement under TSCA as it relates to PFAS and fluorinated polyolefins. These efforts are in line with EPA’s PFAS Strategic Roadmap, which includes steps to further the science and research to restrict these dangerous chemicals from impacting human health and the environment. The letter was originally signed and posted on March 16, 2022. Upon discovering the information for footnote 5 was inadvertently excluded from the original letter, EPA posted a new version of the letter on March 24, 2022 to include that information. View the letter to the fluorinated HDPE industry (pdf) and frequently asked questions related to plastic container fluorination.
- In June 2021, EPA withdrew a compliance guide related to EPA’s July 2020 SNUR on certain long-chain PFAS. The withdrawn compliance guide, which was issued in January 2021, addressed whether certain imported articles were covered by the SNUR. The compliance guide did not consider nor address comments submitted by the public and, after further review, EPA determined the compliance guide inappropriately narrowed the scope and weakened the SNUR. EPA’s July 2020 SNUR continues to be in effect. Articles containing certain long-chain PFAS as a surface coating can not be imported into the United States without EPA review. Importers of articles, but not processors of articles are subject to the SNUR. By lifting the articles exemption for articles that contain certain LCPFAC as part of a surface coating, EPA intended the SNUR to capture the majority of article applications of these chemical substances. Accordingly, EPA considers any LCPFAC (from 40 CFR 721.10536 Table 1 and Table 2) containing coating on any surface of any article, whether the coating is applied to the interior facing surface or the exterior surface of an article or has been cured or undergone a chemical reaction, to be covered by the SNUR. The general nature of a coating is that it is applied to a surface. Additionally, EPA considers all coating layers and their chemical components, even when they are not the outermost layer of an article, to be included as part of a “surface coating.” Read EPA’s July 2020 SNUR.
- In July 2020, EPA issued a final rule strengthening the regulation of PFAS 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. Read the final rule.
- On February 20, 2020, EPA proposed a supplemental SNUR to ensure EPA is notified before anyone begins or resumes the import of long-chain PFAS chemical substances as part of surface coatings on articles. Read the proposed rule.
- On January 21, 2015, EPA proposed a SNUR under TSCA to require manufacturers (including importers) of PFOA and PFOA-related chemicals, including as part of articles, and processors of these chemicals to notify EPA at least 90 days before starting or resuming new uses of these chemicals in any products. This notification would allow EPA the opportunity to evaluate the new use and, if necessary, take action to prohibit or limit the activity.
- On October 22, 2013, EPA issued a rule requiring companies to report all new uses of certain PFOA-related chemicals as part of carpets, a category of potentially harmful chemicals once used on carpets to impart soil, water, and stain resistance. Companies must now report to EPA their intent to manufacture (including import) these chemical substances intended for use as part of carpets or to treat carpets, as well as import carpets already containing these chemical substances.
- On October 9, 2007, EPA finalized a SNUR on 183 PFAS chemicals believed to no longer be manufactured (including imported) or used in the United States. Read more information on the 2007 SNUR for 183 chemicals.
- In 2006, EPA invited eight major leading companies in the PFAS industry to join in a global stewardship program. Read more information on the EPA’s 2010/2015 PFOA Stewardship Program.
- On December 9, 2002, EPA published a SNUR to require notification to EPA before any future manufacture (including import) of 75 PFAS chemicals specifically included in the voluntary phase out of PFOS by 3M that took place between 2000 and 2002. This SNUR allowed the continuation of a few specifically limited, highly technical uses of these chemicals for which no alternatives were available, and which were characterized by very low volume, low exposure, and low releases. Any other uses of these chemicals would require prior notice to and review by the Agency. Read more information on the 2002 SNUR for 75 chemicals.
- On March 11, 2002, EPA published a SNUR to require notification to EPA before any future manufacture (including import) of 13 PFAS chemicals specifically included in the voluntary phase out of PFOS by 3M that took place between 2000 and 2002. This SNUR allowed the continuation of a few specifically limited, highly technical uses of these chemicals for which no alternatives were available, and which were characterized by very low volume, low exposure, and low releases. Any other uses of these chemicals would require prior notice to and review by the Agency. Read more information on the 2002 SNUR for 13 chemicals .
Background
PFAS are synthetic chemical substances with special properties and hundreds of manufacturing and industrial applications. PFOA is a long-chain perfluoroalkyl carboxylic acid (PFCA), a subset of PFAS, that does not occur naturally in the environment.
EPA has investigated PFOA because it:
- Is very persistent in the environment
- Is found at very low levels both in the environment and in the blood of the general U.S. population
- Remains in people for a very long time
- Causes developmental and other adverse effects in laboratory animals.
Uses of PFOA, PFOS, and other PFAS
PFOA was used as an aqueous dispersing agent to make fluoropolymers. PFOA is no longer used in United States to manufacture fluoropolymers but some fluoropolymers containing PFOA are imported as part of articles. Fluoropolymers impart valuable properties, including fire resistance and oil, stain, grease, and water repellency to articles, and are used in many industry segments, including the aerospace, automotive, building/construction, chemical processing, electronics, semiconductors, and textile industries.
PFOA can also be produced by the breakdown of some fluorinated telomers, substances that are used in surface treatment products to impart soil, stain, grease, and water resistance. Some telomers are also used as high-performance surfactants in products that must flow evenly, such as paints, coatings, and cleaning products, fire-fighting foams for use on liquid fuel fires, or the engineering coatings used in semiconductor manufacture.
Use of PFAS in Aqueous Film Forming Foams (AFFF)
AFFF that contain PFAS are typically used to extinguish highly flammable or combustible liquid Class B fires, such as fires involving gas tankers and oil refineries. The biggest users of AFFF are in the U.S. military, petrochemical, and aviation industries.
Releases of AFFF should be minimized because PFAS are persistent in the environment. In using AFFF, care should be taken to minimize its release into the environment. EPA encourages the use of training foams that are available which simulate AFFF without containing PFAS.
EPA’s Investigation of PFOS, PFOA, and Other Long-Chain PFAS
In the late 1990's, EPA received information indicating that PFOS was widespread in the blood of the general population and presented concerns for persistence, bioaccumulation and toxicity. Following discussions between EPA and the 3M, the manufacturer of PFOS, the company terminated production of these chemicals.
Studies have found other related perfluorinated compounds, including perfluoroalkane sulfonates (PFSAs), in very small amounts in the blood of the general human population as well as wildlife. Although most of the health and environmental studies have focused primarily on PFOS, analysis of the structure of the compounds indicates that the results of those studies may be applied to a larger category of PFSA chemicals. EPA believes that the chemical similarity between PFOS and PFSA raises the likelihood that health and environmental concerns are similarly present for PFSA compounds. Following the voluntary phaseout of PFOS by the principal worldwide manufacturer, EPA took prompt regulatory actions in 2002 and 2007 under the TSCA to limit any future manufacture or importation of 271 PFSA chemicals, essentially encompassing all PFSA chemicals on the U.S. market.
Findings on PFOS and PFSA led EPA to review similar chemicals to determine whether they might present similar concerns. The agency began investigating PFOA in 1990s and found that it, too, is very persistent in the environment, is found at very low levels both in the environment and in the blood of the general U.S. population, and causes developmental and other adverse effects in laboratory animals.
EPA summarized its concerns and identified data gaps and uncertainties about PFOA in the April 16, 2003, Federal Register notice. Supporting information is available in EPA docket EPA-HQ-OPPT-2003-0012.
Beginning in 2003, EPA negotiated with multiple parties to produce missing information on PFOA through enforceable consent agreements (ECAs), memoranda of understanding (MOUs), and voluntary commitments. The ECA incineration testing of fluoropolymers and fluorotelomers concluded that the waste incineration of fluoropolymers and fluorotelomer-based polymers does not emit detectable levels of PFOA under conditions representative of typical municipal waste combustor operations in the U.S. and, therefore, is not expected to be a source of PFOA in the environment. All data generated under ECAs is available in EPA dockets EPA-HQ-OPPT-2003-0071 (Fluoropolymer Incineration ECA) and EPA-HQ-OPPT-2004-0001 (Fluorotelomer Incineration ECA). All data generated under MOUs is available in EPA dockets EPA-HQ-OPPT-2004-0112 (3M PFOA MOU) and EPA-HQ-OPPT-2004-0113 (DuPont PFOA MOU). In 2006, EPA and the eight major companies in the PFASs industry launched the PFOA Stewardship program.
EPA evaluates substitutes for PFOA, PFOS, and other long-chain PFASs as part of its review process for new chemicals under TSCA New Chemicals Program. Over 300 alternatives of various types have been received and reviewed by EPA. EPA reviews the new substances against the range of toxicity, fate and bioaccumulation issues that have caused past concerns with perfluorinated substances, as well as any issues that may be raised by new chemistries. EPA requires testing for PFAS chemicals and polyfluorinated ethers it reviews under its new chemical process. For some of these chemicals, EPA requires degradation testing before the chemical can be commercialized.
PFOA Stewardship Program
In 2006, EPA invited eight major leading companies in the per- and PFAS industry to join in a global stewardship program with two goals:
- To commit to achieve, no later than 2010, a 95 percent reduction, measured from a year 2000 baseline, in both facility emissions to all media of PFOA, precursor chemicals that can break down to PFOA, and related higher homologue chemicals, and product content levels of these chemicals.
- To commit to working toward the elimination of these chemicals from emissions and products by 2015.
Participating companies included:
- Arkema
- Asahi
- BASF Corporation (successor to Ciba)
- Clariant
- Daikin
- 3M/Dyneon
- DuPont
- Solvay Solexis
All companies have met the PFOA Stewardship Program goals. Read the final progress reports.
All public documents from the PFOA Stewardship Program are available in EPA Docket EPA-HQ-OPPT-2006-0621.
Read 2010/2015 PFOA Stewardship Program fact sheet for more information.
More information
All of the "EPA-HQ-OPPT" dockets are available on the Federal Dockets website, www.regulations.gov. Use the "Advanced Search" feature and search on the complete docket number.
Administrative Record AR-226 is not currently available online, but copies can be requested on CD-ROM from the EPA Docket Office by calling 202-566-0280 or sending an email request to: oppt.ncic@epa.gov.
EPA has established the following public dockets for the various activities related to PFAS:
- Per- and Polyfluoro Alkyl Substances (PFAS) Designated as Inactive on the TSCA Inventory; Significant New Use Rule; Docket ID number EPA-HQ-OPPT-2022-0867.
- Significant New Use Rule: Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Docket ID number EPA-HQ-OPPT-2013-0225.
- Significant New Use Rule: Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substances Used as Part of Carpets; Docket ID number EPA-HQ-OPPT-2012-0268.
- 2010/2015 PFOA Stewardship Program; Docket ID number EPA-HQ-OPPT-2006-0621.
- Significant New Use Rule: Perfluoroalkyl Sulfonates; Docket ID number EPA-HQ-OPPT-2005-0015.
- DuPont PFOA Site-Related Monitoring and Environmental Assessment at Washington, West Virginia; Docket ID number EPA-HQ-OPPT-2004-0113.
- 3M/Dyneon PFOA Site-Related Monitoring and Environmental Assessment at Decatur, Alabama; Docket ID number EPA-HQ-OPPT-2004-0112.
- Laboratory Scale Incineration Testing of Fluorotelomer-Based Polymers: Final Enforceable Consent Agreement (ECA) and Testing Consent Order; Docket ID number EPA-HQ-OPPT-2004-0001.
- Laboratory Scale Incineration Testing of Fluoropolymers: Final Enforceable Consent Agreement (ECA) and Testing Consent Order; Docket ID number EPA-HQ-OPPT-2003-0071.
- Perfluorooctanoic acid (PFOA), Fluorinated Telomers: Solicitation of Interested Parties for Enforceable Consent Agreement Development; Docket ID number EPA-HQ-OPPT-2003-0012.
- Premanufacture Notification Exemption for Polymers; Amendment of Polymer Exemption Rule to Exclude Certain Perfluorinated Polymers; Docket ID number EPA-HQ-OPPT-2002-0051.
- Significant New Use Rule: Perfluoroalkyl Sulfonates; Docket ID number EPA-HQ-OPPT-2002-0043