Invented in the 1930s, secretly used to develop the atom bomb in the 1940s, and becoming an integral part of the American consumer market beginning in the 1950s, per- and polyfluoroalkyl substances (PFAS) have a protracted history (see PFAS Timeline below). However, not until the early 2000s did regulatory attention begin to focus on this group of chemicals,with some actions undertaken to control releases/exposure. Over the subsequent decades, sporadic regulatory activity mainly focused on voluntary phaseout and product stewardship, and later on formulating general strategies and approaches. The 2020s brought increased federal and state actions/regulations geared toward testing, regulations, and limits. In 2021, federal activity concerning PFAS in the United States (US) amplified in both reach and pace. 

PFAS Timeline

From research, water testing, population exposure surveys, waste management, and analytical method development, to performing assessments, controlling uses, and proposing new rules, the stage has been set for a multifaceted/multi-agency approach to regulating PFAS. The current level of effort and attention given to PFAS has not been similarly extended to a group of environmental chemicals in the past. As more information becomes available on the extent of potential risk PFAS poses to human health and the environment, one could expect the degree of regulatory activity to follow suit. However, some regulatory actions, especially at the state level, are expected to proceed regardless of the scientific information available. 

On April 27, 2021, the memorandum from US Environmental Protection Agency’s (EPA) Michael Regan introduced the “PFAS 2021-2025 – Safeguarding America’s Water, Air, and Land” strategy and confirmed EPA’s intent to make PFAS a priority by moving forward with multifaceted PFAS actions. On October 18, 2021, the agency published the “PFAS Strategic Roadmap: EPA’s Commitment to Action 2021-2024” outlining details of the integrated approach to establish release controls under EPA’s authorities, conduct research to fill critical data gaps, address remediation, and “hold the polluters accountable for the contamination they cause.”  

In continuation of Trihydro’s PFAS article series, we build upon the information presented in Part 1: Existing Rules and Part 2: Emerging and Anticipated Regulatory Developments by discussing the latest federal developments concerning PFAS in water, wastewater, air, waste, and commerce with immediate implications, as well as those slated to occur in 2022 and beyond. 

2021-2024 Federal Actions Watchlist

With so many concurrent PFAS initiatives and activities advancing rapidly, it can be challenging to stay up-to-date. However, the developments outlined below may be worth monitoring as they will likely have a direct impact on industries affected by PFAS. Awareness and pre-planning may help lessen the brunt of these actions.  

Industry Impacts Snapshot

Industries can expect to see impacts on four fronts, with overall impact leading to changes in the way companies conduct business by necessitating additional compliance resources:

1. Controls and restrictions
2. Accountability procedures
3. Compliance/reporting
4. Enforcement actions from regulators

EPA PFAS ACTIONS SET 1 – CONTROLS AND RESTRICTIONS

Key Takeaway: Anticipate Reductions in Allowable PFAS in Water, Air, Soil, Waste, Food, and Commerce

EPA’s objective is to reduce and/or eliminate PFAS from the environment. Preventing entry into water, land, and air, as well as establishing strict exposure controls on consumers, workers, and wildlife is a two-prong approach being implemented for legacy PFAS, as well as for approximately 600 PFAS species still in use. EPA is seeking to apply its existing authorities, rules, and programs to meet its objective.

Limits on Environmental Releases from Operating Facilities

Receiving waters release controls are anticipated for municipal and industrial wastewater sources falling under the federal program by 2024 via the establishment of Effluent Limitation Guidelines (ELGs) for PFAS. ELGs will likely restrict discharges in the following order: 

• ELG Group 1 (organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating)
• ELG Group 2 (electrical and electronic components, textile mills, and landfills)
• ELG Group 3 (leather tanning and finishing, plastics molding and forming, and paint formulating)
• ELG Group 4 (pulp, paper, paperboard, and airports)

As part of this effort, EPA has been collecting information on the nature and extent of PFAS discharges across multiple industries. The sequence of groups subject to ELG activity is based on the amount of data EPA currently has or is anticipated to obtain in near future. Additional details will be provided by the agency in Final ELG Plan 15 (anticipated in Fall 2022).

In concert with ELGs, EPA is working on leveraging existing federal and state National Pollutant Discharge Elimination System (NPDES) programs to reduce point source discharges and monitor quantities discharged. Associated permits will likely be assessed for including conditions on PFAS elimination/industrial process substitution, best management practices (BMPs), and pre-treatment programs for source control. PFAS monitoring will likely employ the new EPA Draft Method 1633 (based on 40 PFAS compounds).

Outside the pending regulatory developments, in early 2022, EPA plans to establish a Voluntary Stewardship Program for Industry to facilitate a proactive venue for organizations that intend to engage in PFAS emission reductions ahead of rulemaking. Program membership and release reporting will not alleviate compliance requirements, but may help companies understand their current PFAS footprint and measure progress over time. Voluntary PFAS emissions reduction metrics may also be a good addition to companies’ Environmental, Social, and Governance (ESG) programs.

Although PFAS compounds are not currently hazardous air pollutants (HAP), EPA is in the process of gathering information on sources, ambient monitoring, stack emissions, releases, exposures, and environmental effects to potentially designate at least some PFAS compounds as such. By the end of 2022, it is expected that EPA will provide additional information, and likely point to adding HAP PFAS compounds to air permits.  

Reductions in Human and Environmental Receptor Exposure

For PFAS currently in commerce, or subject to new uses or de novo synthesis/introduction into US commerce, the reformed 2016 Toxic Substances Control Act (TSCA) seems to be the main statute of choice in preventive control of human and environmental receptor exposure to PFAS. Looking back at the previous new chemical/new use decisions concerning the hundreds of PFAS on the current TSCA Chemical Substance Inventory, it would appear as though EPA may be re-evaluating its earlier decisions. In April 2021, EPA indicated it will deny pending/new TSCA Low Volume Exemptions (LVEs) due to concerns with complex PFAS chemistry, equivocal health effects, and persistence in the environment. Moreover, EPA has encouraged companies to withdraw previous LVEs. Moving forward, EPA will apply a rigorous premanufacture (also includes importation) review process for new PFAS/new uses to ensure sufficient protection of human health and the environment. EPA also plans to revisit past PFAS regulatory decisions and address those deemed insufficiently protective based on the latest information on toxicity, persistence, and exposure. As a result, additional notification, exposure, and release controls are expected to be imposed as conditions on allowing certain PFAS in US commerce. The overall review process and subsequent findings are meant to protect consumers, workers, and environmental receptors.

To aid with waterborne PFAS exposure, EPA is required to finalize the National Primary Drinking Water Regulations (NPDWRs) for perfluorooctanoic acid and perfluorooctane sulfonate (PFOA/PFOS) by 2023. Additional PFAS compounds, as well as groups of PFAS, are considered for future regulatory actions. Somewhat related, but focused more toward recreational and resident wildlife protection, EPA is working on the National Ambient Water Quality Criteria (NAWQC) for PFOA/PFOS, as well as toxicity benchmarks for additional PFAS compounds. The NAWCQ for aquatic life is expected in 2022, with those for human receptors expected in 2024. The latter will account for fish ingestion and water exposure, likely incorporating data from the first National Fish Tissue Survey for PFAS in lakes. On a side note, residues in food from packaging that sometimes uses PFAS in coatings are also of concern to the US Food and Drug Administration (FDA), which require Food Contact Substances (FCS) Notifications for over a dozen PFAS compounds as part of the Federal Food, Drug, and Cosmetics Act (FFDCA). Expanding the list began in 2016 for PFOA and PFOS. In 2022, EPA will publish Health Advisories (HAs) for two additional PFAS: perfluorobutane sulfonic acid (PFBS) and GenX. Additional PFAS HAs can be expected given the pipeline of toxicity assessments for perfluorobutanoic acid (PFBA), perfluorohexanesulfonic acid (PFHxS), perfluorohexanoic acid (PFHxA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA). 

Restrictions in Waste/Contaminated Media

Expected to be effective by 2023, the rule to designate PFOA/PFOS as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA; aka Superfund) hazardous substances would dramatically change the way impacted waste and contaminated site media are addressed. Handling, disposal, and destruction would require hazardous material management and recordkeeping procedures that require specialized training and equipment as well as facility permits. There would also be significant cost and liability implications as discussed below. 

EPA PFAS ACTIONS SET 2 – ACCOUNTABILITY PROCEDURES

Key Takeaway: EPA Will Hold Industry and Other Responsible Parties Accountable

EPA’s stated intent is to place the responsibility for limiting exposures and addressing hazards of PFAS squarely on manufacturers, processors, distributors, importers, users, dischargers, as well as treatment and disposal entities. To do this, the agency is exploring several authorities, but it appears the CERCLA hazardous substance designation is taking center stage. Such designation would not only allow federal, tribal, state, local authorities, and the public to gain information on the nature and extent of PFAS impacts, but would also facilitate recovery mechanisms for costs incurred as part of cleanup activities such as investigation, assessment, remediation, disposal, impacted communities’ assistance/communication/recovery, and oversight. Given that Superfund-type contaminated sites tend to be long-lived and costly to address, inserting a problematic analyte such as PFAS would make an already complicated situation more challenging. Adding the possibility of multiple legacy and contemporary sources, ubiquitous presence, complex mixture/chemistry, largely uncertain adverse effects, additional hazardous substance designations for individual/category/precursor PFAS, and possible closed sites reopeners presents a daunting challenge – perhaps a challenge at a scale not yet seen in the history of environmental site assessment and cleanup. The proposed rulemaking language is projected to be available in Spring 2022, and given the enormity of possible implications, will attract extensive attention.  

EPA PFAS ACTIONS SET 3 - ADDITIONAL REGULATORY COMPLIANCE AND REPORTING

Key Takeaway: Companies Will Need to Invest in Enhanced PFAS Due Diligence

In addition to the new developments in exposure media standards, release limits, hazardous designations, monitoring, and notifications, EPA is also asking for more PFAS information via existing reporting mechanisms. Most notably, the Emergency Planning and Community Right-to-Know Act’s (EPCRA) Toxics Release Inventory (TRI) data submission for the 2021 compounds (172) will be expanded with additional PFAS, bringing the total closer to 200 in 2022, while also becoming more rigorous by removing the existing de minimis limits, as well as reconsidering current exemptions and exclusions.

Further, it seems EPA may not wait for the next TSCA Chemical Data Reporting (CDR) cycle in 2024 to obtain additional PFAS data. Instead, a similar new rule is expected in 2022/2023 that would require one-time TSCA Section 8 reporting on manufacturing (including importing), uses, disposal, exposures, and hazards as far back as 2011. TSCA recordkeeping requirements typically cover five years; asking for information from over a decade ago goes above and beyond current regulatory expectations. Adding to the regulatory burden and costs are the imminent TSCA Section 4 data/test orders for PFAS, requiring certain industries (and/or consortia thereof) to pay for and furnish to EPA specific toxicity and exposure data to fill EPA’s data gaps.

While not directly linked to industry compliance, it is worth noting the scope of the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) is expanding in terms of the number of public water systems that must be tested and the number of PFAS compounds included (up to 20 in 2023), with additional PFAS expected in UCMR 6. The expanded drinking water testing and positive findings may identify certain industries as potential sources, and therefore, they may become subject to regulatory and public attention. 

EPA PFAS ACTIONS SET 4 – ENFORCEMENT ACTIONS

Key Takeaway: Foresee Agency Inquiries, Orders, Audits, Checks, Fines, Non-Compliance Press Releases

EPA is reasserting its enforcement powers within several environmental rules to ensure regulatory compliance and alignment with PFAS goals. In addition to TSCA, CERCLA, and EPCRA, EPA is invoking the Clean Water Act (CWA), Safe Drinking Water Act (SDWA), Clean Air Act (CAA), and – to some extent – the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to gain information on where, and to what extent, PFAS have been manufactured, imported, stored, regulated, controlled, applied, detected, released, processed, deposited, disposed, and destroyed. EPA is conducting data reviews, inspections, TSCA dossier checks, and surveys to gather as much information as quickly as possible to meet its expedited PFAS regulatory schedule. Along the way, parties responsible for PFAS contamination may be expected to characterize the nature and extent of PFAS contamination, put controls in place to expeditiously limit future releases, and address contaminated drinking water, soils, and other contaminated media. EPA is planning to improve approaches for tracking and enforcement of requirements in new chemical consent orders and significant new use rules (SNURs) to ensure companies comply with the terms of those agreements and regulatory notice requirements. The TSCA Chemical Substance Inventory for PFAS subject to SNURs is also up for re-review. 

Looking Ahead

After a pause, which was of concern to multiple state agencies, it would appear EPA has firmly pressed the regulatory pedal for PFAS. The ramping up of multifaceted regulatory actions by EPA across various existing regulatory programs is leading the regulated community closer to specific PFAS rules and regulations, especially concerning water, contaminated sites, wastewater, and solid waste. As such, close surveillance of regulatory developments concerning PFAS should be part of regular compliance due diligence. 

Want to Learn More? 

Facilities that may be affected by the PFAS regulatory actions include those that discharge stormwater or wastewater into national waterways, have operations near bodies of water, have waste disposal sites, manufacture or import chemical substances, deal with consumer products, provide drinking water, or have corrective action sites. Trihydro’s PFAS experts are available to assist companies in understanding the extent to which PFAS regulations may apply to their site(s).

Trihydro is also hosting a webinar on November 18, 2021, dedicated to discussing the latest updates in PFAS regulations and laboratory methods. Learn more and register here.