Questions and Answers about Designation of PFOA and PFOS as Hazardous Substances under CERCLA

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Why is EPA designating PFOA and PFOS as hazardous substances?

EPA is designating PFOA and PFOS, and their salts and structural isomers, as hazardous substances under CERCLA based on significant evidence, including epidemiological and toxicological studies, that PFOA and PFOS, when released into the environment, may present a substantial danger to public health or welfare or the environment.

PFOA and PFOS can accumulate and persist in the human body for long periods of time, and evidence from laboratory animal and human epidemiology studies demonstrate that exposure to PFOA and/or PFOS is linked to adverse health effects, including cancer and effects on the immune system, the cardiovascular system, the liver, and the developing fetus. The latest science is clear: exposure to PFOA and PFOS over long periods of time can result in significant health risks. If not addressed, PFOA and PFOS will continue to migrate, further exacerbating exposure risk and potential cleanup costs.

Designation is needed now to enable EPA to take earlier action and respond to and cleanup contamination. CERCLA designation will help protect public health and the environment from potentially harmful exposure to these chemicals and will provide tools to hold polluters accountable.

CERCLA is the best tool to address wide-spread, existing PFOA and PFOS contamination, which is a nationwide concern. CERCLA is designed to target and prioritize sites that present unreasonable risk to human health. Designation eliminates current barriers to timely cleanup of contaminated sites and enables EPA to pursue parties responsible for significant contamination, which are the parties that should bear the costs of cleaning it up.

What does the rule require? When do these requirements go into effect?

The direct effects of the rule require:

  • Releases of PFOA and PFOS that meet or exceed the reportable quantity within a 24-hour period to be reported to the National Response Center, state or tribal emergency response commission, and the local or Tribal emergency planning committee for the areas affected by the release.
  • Federal entities that transfer or sell their property to provide notice about the storage, release, or disposal of PFOA or PFOS on the property and a covenant (commitment in the deed) warranting that it has cleaned up any resulting contamination or will do so in the future, if necessary, as required under CERCLA 120(h).
  • The U.S. Department of Transportation to list and regulate these substances as hazardous materials under the Hazardous Materials Transportation Act.
  • Owners or operators of any vessel or facility to provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area of any release of these substances.

The rule will be effective 60 days after publication in the Federal Register.

Does designation require response actions (e.g., investigation, cleanup)?

No response actions are required as a result of designation or when there is a release or a report of a release of a hazardous substance. Designation does not automatically require any investigation or cleanup actions.

CERCLA is a discretionary statute, and decisions are made on a site-by-site basis based on whether any releases from the site pose unacceptable risk to human health or the environment.

Designation makes CERCLA’s enforcement tools and cost recovery available for PFOA and PFOS releases, which ensures that the polluters, not taxpayers, pay for or conduct investigations and cleanup, when possible. Designation also means that a finding that a release, or a threat of release, “may present an imminent and substantial danger” will no longer be necessary to respond to a release of PFOA or PFOS. 

How does this action help local and state governments, tribal nations, or members of the public concerned about PFAS contamination?

The rule and the resulting reports of releases would:

  • allow for earlier and additional CERCLA response activities that address areas with high levels of PFOA and PFOS contamination, which translates to a lower risk of adverse health effects for the most exposed communities.
  • help communities with PFOA and PFOS pollution by holding polluters, versus the taxpayers, accountable to address contamination. This includes EPA seeking to recover costs incurred for investigations and cleanup, as well as other actions taken to mitigate immediate exposure, such as providing for alternative drinking water.
  • increase transparency about new releases of PFOA and PFOS and allow EPA and affected states and communities to immediately evaluate a release and quickly respond, as necessary, to address risks to human health or the environment. In addition, state, tribal and local officials will receive immediate notification of these releases so these entities can take actions to protect the community where a release occurs.

The rule may also encourage better waste management and/or treatment practices by facilities handling PFOA or PFOS. Improved management practices would be expected to minimize releases of PFOA and PFOS, which could reduce CERCLA and EPCRA notification requirements and mitigate liability risk.

How does CERCLA operate?

CERCLA is designed to address contamination already in the environment on a site-specific basis, which includes evaluating the nature, extent, and risk to human health and/or the environment from the release or threatened release. CERCLA affords EPA broad discretion as to whether or how to respond to a release. It includes cost-shifting mechanisms and liability provisions that support PRP cleanups rather than relying on the Superfund Trust Fund.

CERCLA is unlike traditional environmental statutes that prospectively regulate, among other things, how facilities operate and provide limitations on discharges, emissions, releases, or disposal of certain chemicals into water, air, or land. Other environmental statutes that complement CERCLA, like the Clean Water Act and Clean Air Act, prospectively regulate, among other things, how facilities operate and provide limitations on discharges, emissions, releases, or disposal of certain chemicals into water, air, or land.

How will the rule impact liability?

Designation does not automatically confer liability, nor does it alter CERCLA’s statutory or regulatory framework for liability. Designation does, however, enable EPA to shift responsibility for cleaning up PFOA and PFOS contamination from the Superfund to those responsible for contamination.

CERCLA is designed to ensure that those responsible for contamination pay to clean it up. Holding those entities responsible that have significantly contributed to contamination is wholly consistent with CERCLA and necessary to address the public health threat posed by PFOA and PFOS. Designation of PFOA and PFOS as hazardous substances supports CERCLA’s primary objectives to clean up contaminated sites and ensure the “Polluter Pays.”

EPA will focus its enforcement efforts on holding responsible those who significantly contribute to the release of PFAS into the environment. CERCLA’s liability limitations, coupled with EPA enforcement discretion policies, such as its policy regarding de minimis or de micromis parties and innocent landowner policies, should minimize hardship for parties that did not significantly contribute to contamination. EPA expects that CERCLA will continue to operate as it has for decades (with respect to the more than 800 existing hazardous substances).

EPA has also developed an enforcement discretion policy that will reflect the Agency's enforcement priorities. As EPA states in the FY 2024-2027 National Enforcement and Compliance Initiatives (NECI), the Agency expects to “focus on implementing EPA’s PFAS Strategic Roadmap and holding responsible those who significantly contribute to the release of PFAS into the environment . . . .” The policy, consistent with EPA’s past practice over decades of implementing the law, also clarifies the agency’s intent not to pursue certain parties such as farmers, municipal landfills, water utilities, municipal airports, or local fire departments, where equitable factors do not support seeking CERCLA cleanup or costs.

EPA has a proven track record of developing and applying enforcement discretion policies that are effective and well-received by stakeholders. These statutory protections and enforcement discretion policies historically have given EPA the needed flexibility to offer liability protections when circumstances warrant.

Will there be an increase in NPL sites as a result of this rulemaking?

EPA does not expect the number of sites on the NPL to substantially increase after designation. EPA has already listed NPL sites in part due to PFOA and PFOS releases. Designation does not automatically make sites eligible for placement on the NPL because of the presence of PFOA and PFOS.

Designation does not change the Hazard Ranking System (HRS), which is EPA’s primary regulation for evaluating releases to determine NPL eligibility. (40 CFR Part 300 Appendix A). The HRS broadly defines “hazardous substance” as including CERCLA hazardous substances, pollutants, and contaminants as defined in CERCLA section 101(14) and 101(33). Available scientific data demonstrate that PFOA and PFOS meet the definition of pollutant or contaminant, and therefore sites with PFOA and PFOS are evaluated in the NPL listing process, regardless of designation.

The HRS process considers several factors for the purpose of scoring a site and determining its eligibility for listing on the NPL. The HRS is designed to assesses the relative potential of sites to pose a threat to human health or the environment. Scores are based on three categories, including the likelihood that a site has released or has the potential to release hazardous substances into the environment; characteristics of the waste (toxicity and waste quantity); and people or sensitive environments (targets) affected by the release. These scores are calculated for one or more pathways including ground water migration, surface water migration, soil exposure and subsurface intrusion, and air migration. If the combined scores meet or exceed the threshold listing score of 28.5, the site is eligible for the NPL.

Even when a site is eligible for the NPL, EPA may choose to not list the site and look to other options. Alternatives to NPL listing may include the Superfund Alternative Approach, state cleanup, cleanup by other federal agencies, EPA removal action, deferral to another EPA program, or various other enforcement mechanisms. Thus, PFOA or PFOS releases may be addressed through non-NPL mechanisms even after designation.

Between FY 2003 and FY 2022, only about four percent of all contaminated sites added to EPA’s Active Site Inventory were placed on the NPL. Since 2013, EPA has, on average, added 11 non-federal sites per year to the NPL, and EPA does not expect the rate at which annual additions to the NPL occur to increase as a result of this rule. For additional context, EPA has added 8 federal sites to the NPL since FY 2000. Moreover, NPL listing does not trigger any immediate actions, liability, or requirements for the site.

Will NPL sites be re-opened?

Designation will not change EPA’s process for listing and/or deleting NPL sites or evaluating remedies’ protectiveness through five-year reviews, and it will not require PFOA and PFOS sampling at NPL (final or deleted) sites.

Five-year reviews provide an opportunity to evaluate the implementation and performance of a remedy to determine whether it remains protective of human health and the environment. Five-year reviews are required whenever a remedial action results in hazardous substances, pollutants, or contaminants remaining on site after completion. EPA, and federal agencies for their facilities, conduct five-year reviews, as required by CERCLA section 121(c), when hazardous substances, pollutants, or contaminants remain on-site at levels that do not allow for "unlimited use and unrestricted exposure."

CERCLA section 121 provides that if an action is needed to assure the remedy remains protective of human health and the environment as a result of findings of a five-year review, those actions can be taken. In some cases, it may be necessary to revise or expand the previous risk assessment as part of a five-year review. For example, the risk assessment may need to be revised when there is a new exposure pathway, a new potential contaminant of concern, or an unanticipated toxic byproduct of the remedy. Five-year reviews (FYR) can also recommend further investigation to determine whether an additional response action is needed. Response actions, including those that may be warranted based on findings in a five-year review, such as starting a new investigation, are contingent, discretionary, and site-specific decisions. They are contingent upon a series of separate discretionary actions and meeting certain statutory and regulatory requirements.

Does the rule require any specific methods for disposal of PFOA or PFOS waste?

The designation of PFOA and PFOS as CERCLA hazardous substances does not require waste to be treated in any particular fashion, nor disposed of at any particular type of landfill. The designation also does not restrict, change, or recommend any specific activity or type of waste at landfills.

What are the sources of public exposure?

For further information regarding sources of public exposure to PFOA and PFOS, please see: Our Current Understanding of the Human Health and Environmental Risks of PFAS.

Will this rulemaking affect consumers using household products containing PFOA or PFOS?

No, designation should not impose any requirements or potential liability on consumers who use household products containing PFOA and PFOS, such as homeowners that use non-stick cooking equipment containing PFOA or PFOS.

Have PFOA and PFOS been phased out? Are they still in use?

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. Small quantities of PFOA may be produced, imported, and used by companies not participating in the PFOA Stewardship Program and some uses of PFOS are ongoing.

What’s the difference between a hazardous substance under CERCLA, a hazardous constituent under the RCRA, and a hazardous waste under RCRA?

RCRA and CERCLA are two different statutes that govern the federal management and cleanup of hazardous waste facilities (RCRA) and response to abandoned, uncontrolled hazardous waste sites (CERCLA). They are not identical statutes but there are many similarities that consistently achieve protection of human health and the environment.

RCRA is the principal Federal law in the U.S. governing the disposal of solid waste and hazardous waste. CERCLA authorizes the President to respond to releases or threatened releases of hazardous substances and pollutants or contaminants into the environment. CERCLA authorities complement those of RCRA, which primarily regulates ongoing hazardous waste management such as handling and disposal. A CERCLA hazardous substance designation does not make PFOA or PFOS contaminated waste a RCRA hazardous waste or a RCRA hazardous constituent.

These concepts are discussed in more detail on our Frequent Questions about Hazardous Waste Identification webpage.

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Last updated on April 19, 2024