At the end of December, the U.S. Environmental Protection Agency announced that it had granted a petition from six North Carolina public health and environmental justice organizations to order company testing on human health hazards regarding certain per- and polyfluoroalkyl substances.

The approval arrives as the Agency continues to address the human health and ecological risks of PFAS.

“Communities in North Carolina and across the country deserve to know the potential risks that exposure to PFAS pose to families and children,” said EPA Administrator Michael S. Regan. “By taking action on this petition, EPA will have a better understanding of the risks from PFAS pollution so we can do more to protect people.

“This data will also help us identify the sources of pollution so we can hold those accountable for endangering the public. EPA is fully committed to addressing this longstanding pollution challenge, and today we take another critical step forward to protect the water, air, and land we all depend on.”

Testing Order

In October 2020, the Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance submitted a petition asking EPA to require health and environmental impact testing on 54 chemical substances that the petition identifies as PFAS manufactured by The Chemours Company in Fayetteville, North Carolina.

While the previous Administration has denied the petition in January 2021, the petitioners reissued their request and asked that the Administration reconsider in March of that same year. By September, the EPA reported that it had agreed to reconsider the petition in light of the change in administration and in policy priorities concerning PFAS.

The following month, the EPA announced a National PFAS Testing Strategy which identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data.

These substances include many of the chemicals identified in the petition, in addition to other PFAS that are slated to inform a wider universe of categories of PFAS where key data is lacking. In the future, the EPA plans to require PFAS manufacturers to provide the agency with toxicity data and information on categories of PFAS. The EPA expects to exercise its TSCA section 4 order authority to require recipients of test orders to conduct and fund the studies.

The collection of PFAS data will help the Agency to better understand the impacts of PFAS, including potential hazards, thus helping the EPA to continue to take action to protect human health and the environment.

© iStock / Skyhobo

At the end of December, the U.S. Environmental Protection Agency announced that it had granted a petition from six North Carolina public health and environmental justice organizations to order company testing on human health hazards regarding certain per- and polyfluoroalkyl substances.

© iStock / Skyhobo

At the end of December, the U.S. Environmental Protection Agency announced that it had granted a petition from six North Carolina public health and environmental justice organizations to order company testing on human health hazards regarding certain per- and polyfluoroalkyl substances.

On Dec. 28, 2021, the EPA granted the petition and agreed to exercise its TSCA authorities to compel development of information on PFAS. In summary:

• Near-Term Testing Covers 30 of 54 Petition Chemicals – Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals.
• Subsequent Testing May Cover nine of 54 Petition Chemicals – An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing.
• Remaining 15 of 54 Petition Chemicals – 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there is robust data on some of them available to the Agency. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing.
• Mixtures Studies – EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS.
• Human Studies – EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to further advance and expand on these efforts. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina.
• Analytical Standards – EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to finalize next year.

Previous, Ongoing Actions

The EPA has been releasing clusters of PFAS news over the past year and now into 2022. In June, it announced three actions, including issuing the proposed rule that it said is designed to gather comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that weakened EPA’s July 2020 Significant New Use Rule restricting certain long-chain PFAS and publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory.

The rule is a statutory requirement under the FY2020 National Defense Authorization Act that would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure and disposal.

The EPA said that this will help the agency understand the sources and quantities of PFAS in the U.S. and support the agency’s PFAS research, monitoring and regulatory efforts. Once finalized, this rule would reportedly be the first targeted effort under the Toxic Substances Control Act to collect information on the manufacture of PFAS.

To assist stakeholders in determining whether or not they have a reportable chemical, the EPA will provide examples, exemption notices and structural diagrams. The proposed deadline for reporting PFAS data to EPA was one year following the effective date of the final rule.

In addition to the new reporting action, the EPA withdrew a compliance guide that it says weakened the July 2020 Significant New Use Rule—this is in accordance with the Biden-Harris administration. The SNUR prohibits companies from importing certain long-chain PFAS as part of a “surface coating” on articles without prior EPA review and approval.

The EPA noted that the guide was issued in January, in the last days of the Trump administration and aimed to limit what would be considered “surface coating.” The guide also was never opened to public comments, the EPA added, saying that it determined that the guide “inappropriately narrowed the scope and weakened the prohibitions included in the SNUR.”

That guide has been removed and is no longer in effect.

Lastly, the EPA had taken the next step to implement a PFAS requirement of the NDAA. The NDAA provided a framework for additional PFAS to be added to TRI on an annual basis. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA has added three PFAS to the TRI list because they are now subject to a SNUR under TSCA.

Per the NDAA requirements, the PFAS additions became effective as of Jan. 1. Reporting forms for these PFAS will be due to EPA by July 1, 2022, for calendar year 2021 data.

At the beginning of that same month, President Joe Biden submitted his budget request of $11.2 billion for the EPA, with emphasis on issues such as the environment, science and support of state and local programs.

The budget breakdown included a provision for PFAS, namely that $75 million will go to accelerate toxicity studies and fund research to inform the regulatory developments of designating PFAS as hazardous substances while setting enforceable limits for PFAS.

In addition to the increase in funding proposed in the budget, Regan issued a memorandum to senior leadership calling for the creation of a new EPA Council on PFAS. The council’s mission is to build the agency’s work to better understand and reduce the risks caused by per- and polyfluoroalkyl substances.

Regan asked Radhika Fox, Principal Deputy Assistant Administrator in the Office of Water, and Deb Szaro, Acting Regional Administrator in Region 1, to convene and lead the EPA Council on PFAS, which will be comprised of senior EPA career officials from across the agency.

The goals of the council date back to a 2019 action plan that was never realized. Directives include:

• Develop "PFAS 2021-2025 - Safeguarding America's Waters, Air and Land," a multi-year strategy to deliver critical public health protections to the American public. To develop the strategy, the ECP will review all ongoing actions, propose any necessary modifications, and identify new strategies and priorities. The ECP shall make initial recommendations within 100 days of its establishment.
• Continue close interagency coordination on regional specific and cross-media issues to assist states, Tribes, and local communities faced with significant and complex PFAS challenges.
• Work with all national program offices and regions to maximize the impact of EPA's funding and financing programs and leverage federal and state funds to support cleanup of PFAS pollution, particularly in underserved communities.
• Expand engagement opportunities with federal, state, and tribal partners to ensure consistent communications, exchange information, and identify collaborative solutions.

That same month, the EPA issued two new updates in emailed press releases, both extending the public comment period for its proposed recordkeeping requirements and releasing data from the 2020 Toxics Release Inventory.

First, the comment period on the proposed reporting and recordkeeping requirements for manufacturers (including importers) of PFAS under section 8(a)(7) of the Toxic Substances Control Act, was extended from an Aug. 27 closing date to Sept. 27.

Second, the EPA released data from the TRI about chemical releases, chemical waste management and pollution prevention activities that took place during 2020 at nearly 21,000 federal and industrial facilities across the country. The preliminary data reportedly includes the first-ever reporting on PFAS added to the TRI by the 2020 National Defense Authorization Act.

The EPA noted that the dataset released is raw data and does not contain any summary or trend analysis and the EPA is now conducting additional quality checks on the preliminary data. The 2020 preliminary data will be updated periodically to reflect revisions to previously submitted data and late submissions of TRI reporting forms.

In September, the EPA announced plans to develop three new rulemakings in regard to identifying opportunities to better protect public health and the environment through regulation of wastewater pollution. In making the announcement, the EPA released Preliminary Effluent Guidelines Program Plan 15 (Preliminary Plan 15), which outlines new regulations to reduce contaminants—including PFAS and nutrients—from key industries.

According to the EPA, the decision to initiate the three new rulemakings arrives after concluding several studies previously discussed in its Effluent Guidelines Program Plan 14. The agency has determined that revised effluent limitations guidelines (ELGs) and pretreatment standards are warranted for:

• Organic Chemicals, Plastics and Synthetic Fibers category to address per- and polyfluoroalkyl substances (PFAS) discharges from facilities manufacturing PFAS;
• Metal Finishing category to address PFAS discharges from chromium electroplating facilities; and
• Meat and Poultry Products category to address nutrient discharges.

The Preliminary Plan 15 also discussed the Steam Electric Power Generating category rulemaking the agency previously announced on July 26. EPA has initiated that rulemaking process to consider strengthening the effluent limits applicable to certain ELG waste streams from coal power plants that use steam to generate electricity.

In November, Regan announced the creation of the Agency’s PFAS Strategic Roadmap to address contamination and set a series of timelines for the EPA to take specific actions and set bolder policies regarding PFAS. In addition, the plan also pledges to conduct more research and testing on hundreds of other PFAS, potentially listing additional compounds as hazardous substances in the future to better safeguard public health, protect the environment and hold polluters accountable.

By 2023, the roadmap aims to set a final rule for PFOS and PFOA regulation in drinking water and will designate two compounds as hazardous substances. That same year, the Agency intends to provide updated research on the available methods for disposing of or destroying PFAS through landfills, thermal treatment and deep-well injection.

According to the White House, the PFAS Strategic Roadmap is just one part of the nation’s plan to combat PFAS contamination. On the same day the roadmap was announced, the Biden Administration issued a multi-agency plan regarding PFAS pollution.

In a combined effort by agencies, including the EPA, the Department of Defense, the Food and Drug Administration, the U.S. Department of Agriculture, the Department of Homeland Security and the Department of Health and Human Services, actions will be taken to prevent PFAS from being released into the air, drinking systems and food supply and to expand cleanup efforts to remediate the impacts of PFAS pollution.

By the end of the month, the EPA asked its Science Advisory Board to review draft documents regarding health effects PFAS. The request for review was a result of recent scientific data regarding the negative health effects of lower levels of PFOA and PFOS than previously understood and that PFOA is likely a carcinogen.

According to the EPA, following peer review, this information will be used to develop Maximum Contaminant Level Goals and a National Primary Drinking Water Regulation for PFOA and PFOS. The agency is also seeking independent scientific review of these documents.