Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution” in July 2021. Under the bill, manufacturers of products with intentionally added per- and polyfluoroalkyl substances (PFAS) must report the presence of the intentionally added PFAS in those products to the Maine Department of Environmental Protection (MDEP) beginning January 1, 2023. The law also prohibits the sale of carpets or rugs, as well as the sale of fabric treatments, that contain intentionally added PFAS beginning on January 1, 2023. Beginning January 1, 2030, any product containing intentionally added PFAS may not be sold in Maine unless the use of PFAS in the product is specifically designated as a currently unavoidable use by MDEP.

According to the MDEP website, MDEP is in the process of developing a rule to clarify the January 1, 2023, reporting requirements. MDEP states that during the rule development process, there will be an opportunity for stakeholder input on the implementation of the program. Stakeholders can subscribe to receive notification of MDEP rulemaking and opportunity to comment notices on its website.

Pending clarification of the reporting requirements, reporting entities may need to request an extension of time to notify MDEP of any products for sale in the state of Maine that contain intentionally added PFAS. At this time, terms in the statutory language are not defined to allow companies to report information with sufficient clarity to comply confidently with the law. Manufacturers will need to obtain information from many industry sectors and upstream suppliers to determine if PFAS was intentionally added to the product or is a component of the product. Suppliers in many industry sectors are numerous, and because of current and ongoing supply chain issues, manufacturers are challenged now more than ever. The frequently asked questions (FAQ) on MDEP’s website list information that will be required, “at a minimum,” but the website states that “[t]hese requirements will be further clarified as part of the rulemaking.”

Tags: Maine, MDEP, PFAS

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2022, that it selected 39 recipients that will receive nearly $12 million in pollution prevention (P2) grants made possible by President Joseph Biden’s Bipartisan Infrastructure Law’s $100 million program investment. According to EPA, the grants will allow states and Tribes to provide businesses with technical assistance to help them develop and adopt P2 practices to prevent or reduce pollution before it is even created, while also reducing business and liability costs. Proposed projects include reducing per- and polyfluoroalkyl substances (PFAS) contamination in food packaging and food waste recycling streams, increasing awareness of green cleaning chemicals in businesses and schools, and helping underserved communities implement P2 best practices to reduce waste and emissions from industrial plants.
 
EPA notes that the P2 program advances President Biden’s Justice40 Initiative, which aims to deliver at least 40 percent of the benefits of certain government programs to underserved communities. State and Tribal programs awarded grants will not be required to provide matching funds, as is required by traditional P2 grants.
 
According to EPA, selected and awarded grantees will document and share P2 best practices they identify and develop through these grants so that others can replicate the practices and outcomes. Each selected grantee will address at least one of the National Emphasis Areas (NEA) established to focus resources to achieve measurable results and to create opportunities to share information among P2 grantees and businesses affiliated with similar NEAs. Each selected grantee will also develop at least one case study during the grant period on P2 practices that are new or not widely known or adopted, or where detailed information on P2 practices could benefit other businesses or P2 technical assistance providers. The NEAs include food and beverage manufacturing and processing; chemical manufacturing, processing, and formulation; automotive manufacturing and maintenance; aerospace product and parts manufacturing and maintenance; metal manufacturing and fabrication; and supporting P2 in Indian country and for Alaska Native Villages.

Tags: P2, PFAS, pollution

 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 6, 2022, the U.S. Environmental Protection Agency proposed to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 87 Fed. Reg. 54415. According to EPA, “[s]uch a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘forever’ chemicals.” Comments are due November 7, 2022. EPA states that under the Paperwork Reduction Act, “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 6, 2022.”
 
Upon designation, any person in charge of a vessel or an offshore or onshore facility, as soon as they have knowledge of any release of such substances at or above the reportable quantity (RQ) must immediately report such releases to the federal, state, tribal, and local authorities. The RQ for these designations is one pound or more in a 24-hour period. EPA states that once it has collected more data on the size of releases and the resulting risks to human health and the environment, it may consider issuing a regulation adjusting the RQs for these substances.
 
The five broad categories of entities potentially affected by this action include:

  • PFOA and/or PFOS manufacturers (including importers and importers of articles);
  • PFOA and/or PFOS processors;
  • Manufacturers of products containing PFOA and/or PFOS;
  • Downstream product manufacturers and users of PFOA and/or PFOS products; and
  • Waste management and wastewater treatment facilities.

More information is available in our August 29, 2022, memorandum.

Tags: PFAS, PFOA, PFOS, CERCLA

 

By Lynn L. Bergeson and Carla N. Hutton
 
ASTM has announced that a new subcommittee will develop standards on per- and polyfluoroalkyl substances (PFAS) that are present in consumer products. ASTM describes PFAS as “a group of chemicals that are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease and water.” The new subcommittee (F15.81) will operate under the jurisdiction of ASTM’s consumer products committee (F15). According to ASTM, the new subcommittee “will develop standards that provide guidance on how to prepare and analyze a wide variety of consumer product samples for PFAS.” ASTM “welcomes participation in the development of its standards. Chemical engineers, analytical chemists, and advocacy group technical personnel are particularly encouraged to join the subcommittee.” More information is available online regarding ASTM membership.

Tags: ASTM, PFAS,

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” EPA states that “[a] growing body of scientific evidence suggests that exposure at certain levels to specific [per- and polyfluoroalkyl substances (PFAS)] can adversely impact human health and other living things.” The webinar will provide a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists will highlight two recently released data sources: EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes, and Systematic Evidence Map for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS. Recent updates to other PFAS resources will also be shared. Registration is now open.

Tags: ORD, PFAS, PFASTT

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

  • Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and
     
  • Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on per- and polyfluoroalkyl substances (PFAS) assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, non-governmental organizations (NGO), industry, and academia; and reviewed key reports. GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:

  • PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available;
     
  • Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods; and
     
  • The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.

GAO developed the following three policy options that could help mitigate these challenges:

  • Promote research: Policymakers could support development of technologies and methods to more efficiently research PFAS health risks. This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning;
     
  • Expand method development: Policymakers could collaborate to improve access to standard reference samples of PFAS and increase the pace of method and reference sample development for PFAS detection. This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies; and
     
  • Support full-scale treatment: Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS. This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.

GAO notes that these policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from fluorinated polyethylene food containers. The purpose of the request is to ensure that FDA has current information to support its review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe. According to the RFI, FDA may use submitted information to update dietary exposure estimates and safety assessments for the authorized food contact use of fluorinated polyethylene. Either electronic or written comments and scientific data and information are due October 18, 2022.
 
The RFI notes that tests performed by the U.S. Environmental Protection Agency (EPA) found that certain PFAS can form and migrate from some fluorinated high-density polyethylene (HDPE, which is a type of polyethylene) containers into the pesticide within the containers. EPA’s testing was conducted on containers that are not FDA-regulated, specifically containers intended to hold mosquito-controlling pesticides. The RFI states that EPA’s testing raises questions about the potential for PFAS to form and migrate from fluorinated polyethylene containers that are intended for food contact use. As such, FDA is interested in obtaining information on current food uses of fluorinated polyethylene containers, as well as information on current manufacturing processes for these containers and any analytical testing information about substances that may migrate from fluorinated polyethylene containers to food. More information on EPA’s testing is available in our October 4, 2021, blog item.


 

 By Lynn L. Bergeson and Carla N. Hutton
 
On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) requested input from all interested parties to identify data gaps in research and development (R&D) regarding several aspects of per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 41749. This information will be used to inform a strategic plan for federal coordination of PFAS R&D and, in compliance with Section 332 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (NDAA), the interagency strategy team on PFAS will also develop an implementation plan for federal agencies.
 
For purposes of the RFI, the term PFAS has the definition provided in NDAA Section 332(g)(1): “(A) man-made chemicals of which all of the carbon atoms are fully fluorinated carbon atoms; and (B) man-made chemicals containing a mix of fully fluorinated carbon atoms, partially fluorinated carbon atoms, and nonfluorinated carbon atoms.” The RFI states that examples of products that use PFAS include food contact materials (e.g., packaging, cookware), stain- and water-repellant fabrics and carpets, and firefighting foams. PFAS may be present in water, soil, air, food, and other materials. According to the RFI, “[r]esearch has shown that PFAS are highly stable chemicals that accumulate in people, animals, and the environment over time, and in several cases, have been shown to cause adverse health effects.”
 
The RFI states that respondents may provide information for one or as many research goals below as they choose:

  • The removal of PFAS from the environment, in part or in total;
  • The safe destruction or degradation of PFAS;
  • The development and deployment of safer and more environmentally friendly alternative substances that are functionally similar to those made with PFAS;
  • The understanding of sources of environmental PFAS contamination and pathways to exposure for the public; and/or
  • The understanding of the toxicity of PFAS to humans and animals.

OSTP states that it is interested in responses to the following questions:

  • Should the federal government consider identifying priority PFAS when developing a strategic plan for PFAS R&D? If so, what criteria should be used to identify priority PFAS for R&D (e.g., tonnage used per year; releases to the environment per year; toxicology or other human or environmental health concerns; or national security or critical infrastructure uses)?
  • Are there criteria that could be applied across the five research goals identified above, or should specific criteria be developed for each individual research goal?
  • Based on the definition of PFAS in the RFI, what are the scientific, technological, and human challenges that must be addressed to understand and to reduce significantly the environmental and human impacts of PFAS and to identify cost-effective:
    • Alternatives to PFAS that are designed to be safer and more environmentally friendly;
    • Methods for removal of PFAS from the environment; and
    • Methods to destroy or degrade PFAS safely?
  • Are there specific chemistries and/or intended uses that PFAS provide for which there are no known alternatives at this time?
  • What are alternatives to the definition of PFAS provided in this RFI? What are the implications of these alternative definitions on possible remediation strategies?
  • What should be the R&D priorities for accelerating progress, improving efficiency, and reducing the cost of: analytical methods, detection limits, and non-targeted detection?
  • What studies would yield the most useful information and address the current gaps in understanding PFAS health effects in humans (e.g., in vitro, animal toxicological, and epidemiological studies)? Which health effects should be prioritized? What additional impacts beyond health should be prioritized? Social scientific approaches are welcome in addressing this question and any others, as appropriate.
  • One challenge across all research goals is PFAS mixtures and formulations. Currently, more information is needed to understand the identity, composition, occurrence, source, or effects on human health and the environment for mixtures of PFAS found in environmental media. Additionally, more information is needed to understand the best way to remediate or destroy media contaminated with multiple PFAS. What should be the R&D priorities for accelerating progress in these areas?
  • What goals, priorities, and performance metrics would be valuable in measuring the success of national, federally-funded PFAS R&D initiatives relating to:
    • The removal of PFAS from the environment;
    • Safely destroying or degrading PFAS;
    • Developing safer and more environmentally friendly alternatives to PFAS; and
    • Mitigating negative human effects of PFAS, whether related to health or additional domains?

Responses are due August 29, 2022.

Tags: OSTP, RFI, Data, PFAS

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 8, 2022, the U.S. Government Accountability Office (GAO) publicly released its 2022 update on its priority open recommendations for the U.S. Environmental Protection Agency (EPA). In June 2021, GAO identified 22 priority recommendations for EPA. According to GAO, EPA has since implemented ten of those recommendations by requiring states to report quarterly to EPA on the number of lead service lines in each public water system in the state and providing direction to staff on integrating climate change information into risk assessments at nonfederal Superfund sites, as well as other actions. GAO states that it is not adding any additional priority recommendations this year. The total number of priority recommendations remaining is 12. These recommendations involve the following areas:

  • Assessing and controlling toxic chemicals;
  • Reducing pollution in the nation’s waters;
  • Ensuring cybersecurity at EPA;
  • Addressing data and risk communication issues for drinking water and wastewater infrastructure;
  • Managing climate change risks; and
  • Protecting the nation’s air quality.

According to GAO, EPA’s continued attention to these issues could lead to significant improvements in government operations.
 
Regarding assessing and controlling toxic chemicals, GAO states that EPA’s ability to help protect public health and the environment effectively “depends on credible and timely assessments of risks posed by toxic chemicals,” including per- and polyfluoroalkyl substances (PFAS). According to GAO, by implementing the following four priority recommendations in this area, EPA would improve its ability to prepare and issue Integrated Risk Information System (IRIS) chemical assessments:

  • To develop the timely chemical risk information that EPA needs to conduct its mission effectively, the EPA Administrator should require the Office of Research and Development (ORD) to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in GAO’s 2008 report and “ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database.”
  • To ensure better the credibility of IRIS assessments by enhancing their timeliness and certainty, the EPA Administrator should require ORD to establish a written policy that clearly describes the applicability of the timeframes for each type of IRIS assessment and ensures that the timeframes are realistic and provide greater predictability to stakeholders.
  • The EPA Administrator should direct the Assistant Administrator of ORD to provide more information publicly about where chemical assessments are in the development process, including internal and external steps in the process, and changes to assessment milestones.
  • The EPA Administrator should include in ORD’s strategic plan (or subsidiary strategic plans) identification of EPA’s universe of chemical assessment needs; how the IRIS Program is being resourced to meet user needs; and specific implementation steps that indicate how IRIS will achieve the plan’s objectives, such as specific metrics to define progress in meeting user needs.

 
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