By Lynn L. Bergeson and Carla N. Hutton
 
On March 1, 2021, the U.S. Government Accountability Office (GAO) publicly released a report entitled Man-Made Chemicals and Potential Health Risks:  EPA Has Completed Some Regulatory-Related Actions for PFAS.  GAO was asked to examine the status of regulatory-related actions in EPA’s 2019 Per- and Polyfluoroalkyl Substances (PFAS) Action Plan.  GAO found that EPA completed three of six selected regulatory-related actions for addressing PFAS outlined in the PFAS Action Plan.  For two of the three completed actions, the steps EPA took were also in response to the National Defense Authorization Act for fiscal year 2020 (FY20 NDAA):

• After proposing a supplemental significant new use rule (SNUR) in February 2020, EPA met a June 2020 deadline set in the FY20 NDAA when the EPA Administrator signed the final rule.  Among other things, under the final rule, articles containing certain PFAS as a surface coating, and carpet containing certain PFAS, can no longer be imported into the United States without EPA review; and
   
• EPA incorporated 172 PFAS into the Toxics Release Inventory in June 2020.  The FY20 NDAA directed EPA to take this action, extending EPA’s original planned action to explore data for listing PFAS chemicals to the inventory.

Finally, in March 2020, EPA completed a third regulatory-related action, not required under the FY20 NDAA, when it proposed a preliminary drinking water regulatory determination for two PFAS, “an initial step toward regulating these chemicals in drinking water.”
According to GAO, three of the six selected regulatory-related actions are ongoing, and EPA’s progress on these actions varies:

• As of August 2020, EPA was developing a proposed rulemaking for a nationwide drinking water monitoring rule that includes PFAS, which EPA officials stated that EPA intends to issue in final by December 2021;
   
• EPA is currently examining available information about PFAS discharges to surface water to identify industrial sources that may warrant further study for potential regulation through EPA’s National Effluent Limitations Guidelines.  EPA expects to publish a final Effluent Guidelines Program Plan 14 in early 2021 that will include an update on the current status of EPA’s multi-industry study; and
   
• EPA plans to continue the regulatory process for designating two PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which would allow EPA to require responsible parties to conduct or pay for cleanup.  On January 14, 2021, EPA issued an advance notice of proposed rulemaking for the hazardous substances designation to obtain public comment and data to inform EPA’s ongoing evaluation of the two PFAS.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 11, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for asbestos, part 1:  chrysotile asbestos.  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for asbestos, part 1:  chrysotile asbestos.  As reported in our January 4, 2021, memorandum, of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories.  EPA found no unreasonable risk to the environment.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by February 25, 2021.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulation.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On December 22, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of new interim guidance on destroying and disposing of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS) and PFAS-containing materials for public comment.  85 Fed. Reg. 83554.  The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products, including aqueous film-forming foam for firefighting.  According to EPA’s December 18, 2020, press release, the interim guidance assembles and consolidates information in a single document that generally describes thermal treatment, landfill, and underground injection technologies that may be effective in the destruction or disposal of PFAS and PFAS-containing materials.  To help ensure informed decision-making, the technology-specific information describes uncertainties and how those uncertainties should be weighed given situation-specific factors, such as the waste’s physical phase (liquid, solid, gas).
 
As required by the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA), the interim guidance addresses PFAS and PFAS-containing materials including:

• Aqueous film-forming foam (for firefighting);
• Soil and biosolids;
• Textiles, other than consumer goods, treated with PFAS;
• Spent filters, membranes, resins, granular carbon, and other waste from water treatment;
• Landfill leachate containing PFAS; and
• Solid, liquid, or gas waste streams containing PFAS from facilities manufacturing or using PFAS.

EPA notes that the interim guidance is not intended to address destruction and disposal of PFAS-containing consumer products, such as non-stick cookware and water-resistant clothing.  EPA is also providing guidance on testing and monitoring air, effluent, and soil for releases near potential destruction or disposal sites.  The interim guidance captures the significant information gaps associated with PFAS testing and monitoring and identifies specific research needs to address the FY20 NDAA requirements.  Comments are due February 22, 2021.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns.  In addition to being open to the public, EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.  EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.”  EPA notes that there will also be an open public comment period on proposed risk management regulations.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2020, a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final Toxic Substances Control Act (TSCA) chemical risk evaluations.  After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust process to gain important feedback from stakeholders on the options for managing those risks.”  EPA will hold two public webinars to kick off this outreach effort:

• The first webinar, scheduled for September 16, 2020, will feature a discussion of the findings from the final risk evaluation for methylene chloride.  More information on EPA’s final risk evaluation is available in our June 25, 2020, memorandum; and
• The second webinar, scheduled for September 30, 2020, will include a discussion of the findings from the final risk evaluation for 1-bromopropane.  More information on EPA’s final risk evaluation is available in our August 11, 2020, memorandum.

According to EPA, each webinar will provide an overview of the TSCA risk management process and the tools available to manage the unreasonable risks.
 
EPA intends to schedule additional public webinars as it begins the risk management process for chemicals with unreasonable risks.  EPA states that it will also begin one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  EPA notes that there will be an open public comment period on any draft risk management regulation.
 
According to EPA, there are several actions it can take under TSCA to address unreasonable risks, including banning a chemical; restricting the manufacturing, processing, distribution, or use; requiring warning labels/testing; and requiring manufacturers to notify distributors of any unreasonable risks. EPA has up to one year after issuing a final risk evaluation to propose and take public comments on any risk management actions.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On July 27, 2020, the U.S. Environmental Protection Agency (EPA) promulgated a final significant use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances.  85 Fed. Reg. 45109.  The final SNUR requires persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemical substances for the significant new uses described in the notice.  The required significant new use notification initiates EPA’s evaluation of the conditions of use associated with the significant new use.  Manufacturing (including import) or processing for the significant new use are prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.  EPA notes that as with any SNUR, the final rule excludes ongoing uses as ongoing uses cannot be subject to a SNUR.  The final rule will be effective September 25, 2020.  More information on the final SNUR is available in our July 27, 2020, memorandum.

• Email This
• Print

Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (B&C^®) affiliate The Acta Group (Acta^®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold.

CDR Cross-Check will identify:

• Whether the chemical is listed as active or inactive;
   
• Whether the chemical was subject to specific TSCA regulatory actions in 2016;
   
• Whether the chemical is exempt; and
   
• What the reporting thresholds are based on the updated data released by the U.S. Environmental Protection Agency (EPA) on May 29, 2020.

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.”  The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council.  According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chlorid[]e from their air and water.”

As reported in our June 25, 2020, memorandum, “Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments,” after evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under any conditions of use.  Release of a final risk evaluation is the last step in the Toxic Substances Control Act (TSCA) Section 6(b) process and will guide EPA’s efforts in applying Section 6(a) to reduce human exposure to methylene chloride “so that the chemical . . . no longer presents such risk.”  EPA “will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.”  EPA could prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of methylene chloride.  Any regulatory action will include opportunities for public comment.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina.  OIG notes that GenX chemicals are a type of per- and polyfluoroalkyl substances (PFAS) found in surface water, groundwater, drinking water, rain water, and air emissions.  OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the consent order requirements designed to reduce risks in the manufacture of GenX chemicals.  Under the 2009 Consent Order, EPA required DuPont to determine how to recover and capture 99 percent of GenX’s manufacturing discharges and air emissions.  The Consent Order was not reviewed or approved by the Office of Enforcement and Compliance Assurance (OECA), which is responsible for conducting inspections to verify compliance, however.  Until June 2017, EPA’s actions to verify compliance with the 2009 Consent Order and new chemicals testing requirements consisted of tracking and reviewing information provided by the manufacturer.  According to OIG, following the local media coverage of the presence of GenX chemicals in the Cape Fear River in 2017, Region 4 and EPA contractors conducted EPA’s first on-site compliance monitoring inspection at the Fayetteville Works facility, which manufactures GenX.  OIG found that the Region 4 inspectors were unaware of the 2009 Consent Order and its requirements until the inspection was requested by EPA headquarters.
 
OIG recommends that EPA establish and implement processes:

1. For OECA to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and
    
2. To provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final consent orders.

OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.”  For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable.  OIG considers Recommendation 2 resolved with corrective action pending.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS).  According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes.  EPA states that Swix violated the TSCA Premanufacturing Notice requirements and Import Certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes.  Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States.
 
Under the terms of the settlement, Swix has agreed to spend approximately $1 million to develop and implement an outreach and training program referred to as a Responsible Waxing Project (RWP) and pay a $375,625 civil penalty.  The RWP is aimed at:  (1) educating the ski racing community about PFAS chemicals in racing waxes and their impact on the environment; and (2) promoting the use of wax alternatives with lower environmental impact, including but not limited to racing waxes that are PFAS-free.  Another objective of the RWP is to educate and motivate the ski racing community to phase out (and ultimately eliminate) the use of PFAS-containing waxes in ski racing beginning with the 2020 ski season.
 
EPA notes that the RWP has several elements, including an education and training component for ski wax technicians on the proper disposal of racing wax shavings and the use of appropriate personal protective equipment (PPE) during the waxing process.  Other RWP elements include:

• PFAS ski wax education program, including two on-site presentations at a major ski event that attracts more than 10,000 participants;
   
• Training for wax technicians on the proper use of PPE, proper ventilation, and proper disposal of wax shavings;
   
• Program for ski wax coaches available online and used at on-site presentations at a minimum of ten events designed for coach certifications;
   
• Additional outreach to college racing teams and clubs that educates high school and college level skiers about the RWP content;
   
• A dedicated Swix project manager who oversees the project to completion;
   
• Website development for all videos created as part of the settlement for technicians, coaches, and teams; and
   
• Distribution of PFAS alternative wax information materials at a minimum of 50 ski sites.

EPA’s Environmental Appeals Board approved the consent agreement and final order on May 13, 2020.

• Email This
• Print