Merry Christmas! PFAS, PFAS, and More PFAS
BREAKING NEWS! ASTM Standard with PFAS Measure Added to ‘Due Diligence’ Rule
This week, Inside EPA reported that the US EPA has finalized a brownfields “due diligence” rule that incorporates a revised industry site assessment standard that includes per- and polyfluoroalkyl substances (PFAS). This action effectively rejects industry’s request to exclude the PFAS measure for fear it will prematurely expose parties to liability under the Superfund law. The final rule, expected to be published in the Federal Register this week, incorporates a 2021 American Society for Testing and Materials (ASTM) Phase 1 site assessment standard, known as ASTM E1527-21 standard practice, into the agency’s “Standards and Practices for All Appropriate Inquiries” (AAI). Under the brownfields law, compliance with AAI’s requirements provides prospective purchasers of contaminated properties and other parties with a defense against Superfund liability.
The new ASTM standard adds the option of including PFAS when assessing potentially contaminated properties, and also includes other updates to bolster the quality of site assessments.
While the agency rejected a request from the U.S. Chamber of Commerce to exclude a section of the 2021 ASTM standard that suggests including PFAS in assessments, US EPA modified a proposal that would have allowed parties to comply with AAI requirements by following either the 2021 standard or ASTM’s prior 2013.
Pushback from industry and brownfields transaction experts over US EPA’s plan to continue to allow compliance with a 2013 standard as sufficient to meeting AAI requirements has now prompted the agency to sunset the earlier standard within one year.
According to the prepublication version of the final rule, US EPA says it is amending its AAI rule to reference ASTM E1527-21 standard practice “and allow for its use to satisfy the requirements for conducting all appropriate inquiries under the Comprehensive Environmental Response, Compensation and Liability Act [(CERCLA)], and to remove after one year recognition of the previous version of that standard, ASTM E1527-13, as compliant with the AAI rule.” In the final rule, US EPA says most commenters supported referencing the 2021 ASTM standard in the rule and allowing for its use to satisfy AAI requirements.
Proposed Ruling has Staggering Implications
On September 6, 2022, the US EPA proposed designating PFOA and PFOS as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) hazardous substances [87 Federal Register 54415]. The implications of this proposed ruling are staggering and, if finalized, will potentially pave the way for a similar universal designation under other regulatory programs. The technical, financial, and practical flaws of this proposed rulemaking are far reaching. It is clear that the US EPA did not conduct a robust analysis of the impacts required for an economically significant rule. Particularly, for small business and public entities, the US EPA has not identified a compelling public need for the proposed rule, the US EPA failed to establish a clear baseline for its analysis, and ultimately has not considered regulatory alternatives. Finally, and of critical significance, the US EPA has not established the means or capacity for the disposal and destruction of waste containing PFOA and PFOS.
Drinking Water Contaminant List Expands PFAS Class
The US EPA has expanded its definition of the PFAS class that it is identifying for potential regulation under the Safe Drinking Water Act (SDWA) to include related chemicals that are known to be found in drinking water, although the new definition does not appear to be as broad as agency science advisors urged and applies only to this list of substances. On November 2, US EPA released a pre-publication version of its final fifth contaminant candidate list (CCL5), which includes 66 chemicals, 12 microbial contaminants, and three contaminant groups – cyanotoxins, disinfection byproducts, and PFAS.
“As EPA takes action to protect public health and the environment from PFAS, including proposing the first nationwide drinking water standards later this year, today’s final CCL5 looks further forward to consider additional protective steps for these forever chemicals,” said US EPA Assistant Administrator for Water Radhika Fox.
The draft CCL5 defined PFAS as chemicals with the any of the three following structures:
- R-(CF2)-C(F)(R’)R’’ where the CF2 and the CF moieties are saturated carbons and none of the R groups can be hydrogen.
- R-CF2OCF2-R′, where both the CF2 moieties are saturated carbons, and none of the R groups can be hydrogen.
- CF3C(CF3)RR′, where all the carbons are saturated, and none of the R groups can be hydrogen.
But drinking water utilities and environmentalists urged US EPA to expand its definition, as did SAB. “An expansive definition of PFAS would allow a focus on a broad range of compounds of potential health risk,” SAB said in its final report in August, suggesting the use of the Organization for Economic Co-operation and Development’s (OECD) 2021 definition, “which defines PFAS as any compound that contains at least one fully fluorinated methyl or methylene carbon atom (i.e., without any H/Cl/Br/I atom attached to it).”
However, industry groups oppose such broad regulatory approaches, arguing that not all PFAS pose the same risks and can lead to regulation of useful and necessary products. But US EPA in the final CCL5 says it “agrees with the commenters who recommended expanding the CCL5 PFAS definition and in response, US EPA is expanding the CCL5 PFAS structural definition,” although it is not using the OECD definition. The agency emphasizes that this revised definition is only for the purposes of CCL5 and is not meant to represent an agency-wide definition. “The definition could be revised for future cycles as more information is gathered on PFAS,” US EPA says. The final CCL5 says “EPA is also aware there may be emerging contaminants such as fluorinated organic substances that may be used in or are a result of the PFAS manufacturing process (e.g., starting materials, intermediates, processing aids, by-products and/or degradates) that do not meet the structural definition.”
Method 1633 Posted (40 PFAS Compounds)
On September 2, 2021, The US EPA Office of Water solicited comments on its document, “Analysis of Per- and Polyfluoroalkyl Substances (PFAS) in Aqueous, Solid, Biosolids, and Tissue Samples by LC‑MS/MS” (Draft Method 1633, dated August 2021). The document was posted on the US EPA website (EPA Announces First Validated Laboratory Method to Test for PFAS in Wastewater, Surface Water, Groundwater, Soils | US EPA). While this document provides meaningful steps forward in terms of formalizing the analysis of 40 PFAS compounds in a variety of matrices (wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue), the document ultimately needs to be proposed as a draft method as part of formal rulemaking. The published version of the method on the
US EPA website was based on a single-laboratory method validation; however, the single-laboratory method validation report and supporting data have yet to be formally posted for review/comment under 40 CFR Part 136. Of concern regarding the informal posting of this document, are the following comments included in the background information:
“This draft method can be used in various applications, including National Pollutant Discharge Elimination System (NPDES) permits. The method will support NPDES implementation by providing a consistent PFAS method that has been tested in a wide variety of wastewaters and contains all the required quality control procedures for a CWA. While the method is not nationally required for CWA compliance monitoring until EPA has promulgated it through rulemaking, it is recommended now for use in individual permits.”
The above statement regarding draft method 1633 circumvent any reasonable Alternate Test Procedure (ATP) guidance.
Method 1621 Posted (Possible Proxy for Total PFAS?!)
During April 2022, The US EPA Office of Water solicited comments on its document, “Screening Method for the Determination of Adsorbable Organic Fluorine (AOF) in Aqueous Matrices by Combustion Ion Chromatography (CIC)” The document was posted on the US EPA website. The published version of the method was based on a single-laboratory method validation document, which was also posted on the US EPA website.
It is noteworthy that a (total) adsorbable fluorine method is being published, as one could easily predict this method being construed as proxy for “Total per- and polyfluoroalkyl substances (PFAS),” the implications of which will be challenging for toxicologists tasked with developing health-based guidelines, and worse yet, standards. The document ultimately needs to be proposed as a draft method as part of formal rulemaking. Thankfully, unlike the posting of Method 1633, the posting of this method is clear in stating that, “This method is not approved for Clean Water Act compliance monitoring until it has been proposed and promulgated through rulemaking.”
A single-laboratory validation report in support of this method was posted and it was stated that the US EPA expects to begin a multi-laboratory validation study of the procedure before the end of 2022. Once the multi-laboratory validation study is completed the US EPA will finalize the method and include performance criteria.
After posting comments to the US EPA on both Method 1633 (Rev1) and 1621 on behalf of the American Petroleum Institute, the American Chemistry Council, and a number of interested industrial sponsors, a conference call was scheduled on October 14, 2022. Attendees included six US EPA personnel and five Environmental Standards senior chemistry personnel.
The objective of the call was to discuss the next steps and timing for Draft Methods 1621 and 1633 and to emphasize several items presented as part of the comments and suggestions documents for Draft Methods 1621 and 1633 submitted by Environmental Standards on behalf of our sponsors.
For Draft Method 1621, US EPA personnel indicated that the next step is to initiate the multi‑laboratory validation study. The US EPA indicated that approximately 10 laboratories have been contracted for the multi‑laboratory study. The timing for the completion of the multi-laboratory study is unknown. The US EPA did not provide a timeline for posting the next revision to the method and the multi-laboratory validation study for comment and ultimately for promulgation.
For Draft Method 1633, US EPA personnel indicated that the next step was to receive the results for the multi‑laboratory validation study, consolidate laboratory and other comments on the draft method, and present the revised method and multi-laboratory validation study for promulgation under 40 CFR Part 136. The US EPA is looking to finish the next revision of the method for comment by the end of 2022, but was non-committal as to when a Methods Update Rule would be proposed to promulgate the method for use in NPDES permits. US EPA indicated that the intention is to present a NPDES-focused aqueous portion of Method 1633 and intends to include other matrices as appendices. US EPA indicated that the method Team’s focus is on wastewater.
For insights on additional commentary and dialogue between Environmental Standards and the US EPA on Method 1633 and Method 1621, contact Rock Vitale.
Consumer Products and a Container Study
The media and general public at large have gone PFAS crazy about ppt levels of these PFAS compounds in drinking water, food and beverages, and even air. Recently, non-governmental organizations (NGOs) have raised questions about the presence of these compounds in consumer products of virtually very shape and size. The Environmental Standards chemistry group was recently retained to assist in the design a multi-month study comparing the potential of PFAS to leach into high-density polyethylene (HDPE) containers. The study was recently published in the journal Environmental Advances.
In further response to NGO inquiries and potential regulatory concerns, the American Society of Testing and Materials (ASTM) Committee F15 formed a subcommittee on PFAS to develop guidance on PFAS that are present in consumer products.
While active on a number of ASTM committees, Environmental Standards’ Managing Principal, Rock Vitale, was appointed by ASTM as Co-Chair of this important subcommittee. “PFAS are intentionally added to or inadvertently present as a component in a significant number of consumer products,” said Vitale. “The new subcommittee will provide guidance on how to prepare and analyze a wide variety of consumer product samples for PFAS. This guidance will provide useful information to legislative and regulatory bodies and trade associations regarding the presence and levels of PFAS in consumer products,” said Vitale.
While there are more than 9,000 PFAS compounds in commerce, the guidance provided by the subcommittee will focus on those that are of greatest concern to human and environmental health.
This effort directly relates to the United Nations Sustainable Development Goals #3 on good health and well-being, #6 on clean water, and #14 on life below water. ASTM welcomes participation. Become a member at www.astm.org/JOIN. Chemical Engineers, Analytical Chemists, and advocacy group technical personnel are particularly encouraged to join the subcommittee.