EPA Issues National Testing Strategy for PFAS Used in Chemical Manufacturing

August 21, 2023
The U.S. Environmental Protection Agency (EPA) issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy, the latest action taken under EPA’s PFAS Strategic Roadmap to confront contamination from forever chemicals nationwide.
 
Today’s action orders the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), a substance used as a reactant in organic chemical manufacturing. HFPO-DAF is known to be used to make the chemical Hexafluoropropylene Oxide (HFPO) Dimer Acid (CASRN 13252-13-6), also known by the trade name GenX. HFPO-DA is used in the production of nonstick coatings, stain repellent, and other consumer and industrial products and was widely used to replace PFOA. More than 1 million pounds of HFPO-DAF are manufactured each year, according to TSCA Chemical Data Reporting rule reports.
 
“We still don’t know enough about the dangers that many PFAS might pose to human health,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “We’re using all the tools at our disposal to rapidly gather data about these substances so that we can better understand the potential environmental and human health impacts of PFAS and take any necessary steps to address them.” 
 
After thoroughly examining existing hazard and exposure data, EPA has concluded that HFPO-DAF may present an unreasonable risk of injury to health or the environment. The potential hazards from exposure to this chemical could include organ damage, including to the eyes and skin, as well as cancer. EPA has also concluded that workers may be exposed to HFPO-DAF. Additionally, EPA’s recent proposal to regulate six PFAS in drinking water, including HFPO-DA and its salts, isomers, and derivatives which includes HFPO-DAF, found there was a meaningful opportunity to reduce health risks to people consuming drinking water contaminated by these PFAS. The test order will help EPA better understand the potential hazards and potential exposures associated with HFPO-DAF.
 
The information EPA receives under this order will not only improve the Agency’s understanding of human health effects of HFPO-DAF, but also the potential effects of dozens of PFAS that are structurally similar to HFPO-DAF and in the same Testing Strategy category of PFAS, improving the agency’s overall data on PFAS.  
 
The companies subject to the test order may either conduct the tests as described in the order, including testing of physical-chemical properties and health effects following inhalation, or provide EPA with existing information they believe EPA did not identify in its search, but which satisfies the order requirements. 
 
EPA encourages companies to jointly conduct testing to avoid unnecessary duplication of tests and will also consider possible combinations of tests that cover all required endpoints to diminish the amount of time, animal subjects and costs required. 
 
The order employs a tiered testing process, as TSCA requires. The results of all the first-tier testing are required to be submitted to EPA within 446 days of the effective date of the order and will inform the decision as to which additional tests are necessary. The order and any data submitted in response to this order will be made publicly available on EPA’s website and in the applicable docket on www.regulations.gov, subject to confidentiality considerations under TSCA section 14.
 
PFAS National Testing Strategy
 
In the National Testing Strategy, EPA assigned PFAS into smaller categories based on similarities in structure, physical-chemical properties, and existing toxicity data. EPA is issuing test orders for PFAS in specific categories that lack toxicity data to inform EPA’s understanding of the potential human health effects. 
 
The first test order was for 6:2 fluorotelomer sulfonamide betaine, a PFAS used in commercial firefighting foam. The second was for HFPO, a PFAS used to manufacture plastics. As EPA continues to further develop the Strategy, refine its universe and categorization of PFAS, and consider stakeholder feedback, the Agency also plans to increase the weight it places on the potential for exposures when identifying which specific PFAS to require testing on.
 
Section 4 Test Orders
 
Developing section 4 test orders is a complex and resource-intensive process involving many scientific and regulatory considerations, as explained in the Overview of Activities Involved in Issuing a TSCA Section 4 Order. Given the complexity of the testing requirements, a broad spectrum of experts across the agency worked to determine testing methodology and needs and address other details of drafting and issuing an order, such as assessing the economic burden of an order.
 
Additionally, one order often applies to multiple companies. EPA must identify these companies and their associated points of contact. To improve the transparency of the process, EPA also works to resolve confidential business information claims that could prevent EPA from publicly connecting the company to the chemical substance prior to issuing test orders.
 
Washington Company Found Violating Environmental Laws, Made to Pay $850k
 
The U.S. Environmental Protection Agency announced today that Multistar Industries Inc. of Othello, Washington, will pay $850,000 for violations of environmental laws.
 
On Aug. 1, the U.S. District Court for the Eastern District of Washington ordered Multistar to pay the penalty for five violations of the Clean Air Act Risk Management Program and two violations of the Emergency Planning and Community Right-to-know Act. The violations relate to Multistar’s storage of a hazardous chemical called trimethylamine or TMA at its facility in Othello, Washington. 
 
In addition to the penalty, the Court granted EPA’s request for an injunction, which requires Multistar to come into immediate compliance with Clean Air Act requirements and submit semi-annual reports for the next five years showing ongoing compliance. In its order, the Court called Multistar’s violations “extremely serious” and stated that the company’s conduct “places workers lives at risk as well as the lives of the people in the community. ”
 
Multistar began storing TMA in rail cars at its facility beginning in 2017, but only took steps to come into compliance with CAA and EPCRA requirements after EPA began an investigation into the operation in 2019. Even then, the Court found that Multistar had not come fully into compliance with CAA requirements as of the time of trial. Multistar has a long history of compliance issues at the facility, with prior violations settled with EPA in 2005, 2016, 2019 and 2021.
 
“This ruling was a huge win for preventing chemical accidents,” said EPA Region 10 Office of Enforcement and Compliance Assurance Director Ed Kowalski. “EPA’s Risk Management Program and the Emergency Planning and Community Right-to-Know-Act both focus on planning for and preventing accidental releases of hazardous substances, especially where there are large vulnerable populations.”
 
Multistar stored an average of 696,380 pounds of TMA in unmotorized rail cars since 2019. They increased their inventory capacity from an average 156,988 pounds in 2018.
 
Trimethylamine is a highly flammable substance that is corrosive to the eyes, the skin, and the respiratory tract. It is commonly used in the manufacture of electronics, explosives, pharmaceuticals, paper, and is an additive in gasoline. 
 
Ohio Foundry's Safety Procedures Failure Led to Fatal Steam Explosion
 
Federal workplace safety inspectors have again cited a Wilkes-Barre roofing contractor for exposing employees to falls, this time as they worked on the roof of a commercial building in Honesdale.
 
Inspectors with the U.S. Department of Labor’s Occupational Safety and Health Administration observed employees of Avila’s Roofing LLC working at heights of up to 27 feet in February 2023 without fall protection, in violation of federal workplace safety requirements. They also learned the company had not provided employees with effective training on fall hazards and allowed them to work without eye and face protection when potential risks of eye or face injury existed.
 
OSHA cited Avila’s Roofing for two willful and two serious safety violations and one other-than-serious violation. The violations carry $328,143 in proposed penalties.
 
“OSHA will not tolerate this company’s continued failure to protect its employees against potentially deadly and disabling hazards,” said OSHA Area Director Mary Reynolds in Wilkes-Barre, Pennsylvania. “Falls are the leading cause of death in construction work, and employers are legally required to plan ahead, provide workers with effective tools and training, and conduct frequent inspections to make sure jobs are done safely.”
 
In five inspections of Avila’s Roofing worksites in Honesdale and Scranton, OSHA has proposed $178,649 in penalties for repeated failures to comply with federal requirements for fall protection.
 
The company has 15 business days from receipt of its citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
 
Federal Investigators Find Ohio Foundry's Failure of Safety Procedures Led to Fatal Steam Explosion
 
A federal workplace safety investigation into a Beford foundry explosion that caused the death of a maintenance supervisor and injuries to 15 other employees found the operator, I. Schumann & Co. LLC, failed to protect workers from the hazard of steam explosions.
 
Inspectors with the U.S. Department of Labor's Occupational Safety and Health Administration learned the explosion happened while employees inspected a water leak on a furnace used to smelt solid metals. OSHA determined water leaked onto the molten metal inside the furnace, causing a steam explosion. Inspectors found the company did not make sure that required lockout/tag out procedures were followed during the inspection of the furnace.
 
"This terrible tragedy could have been avoided if the employer followed well-known machine safety standards that are meant to prevent this type of explosion," explained OSHA Area Director Howard Eberts in Cleveland, Ohio. "Sadly, a worker lost his life and 15 others were hurt in an incident that was entirely preventable. It’s exactly why employers need to follow required safety procedures and train their employees."
 
OSHA cited the company for six serious violations and has proposed $62,500 in penalties. The foundry remains closed since the explosion.
 
Based in Bedford since 1917, I. Schumann & Co. today recycles material into metal alloys, ingots and pellets.
 
EPA Settlements with Maine Companies Improve Chemical Safety with Over $370,000 in Penalties
 
In the last year, the U.S. Environmental Protection Agency (EPA) reached settlements with two Maine based companies – Jasper Wyman & Son and Barber Foods – for chemical safety violations, resulting in $373,490 in combined penalties. In addition, one of the companies agreed to conduct Supplemental Environmental Projects (SEPs). Both companies use anhydrous ammonia as a refrigerant at their facilities.
 
"Despite EPA's efforts to improve compliance at facilities that use anhydrous ammonia as a refrigerant, our inspectors continue to see many troubling violations of the Clean Air Act's chemical accident prevention requirements – in particular, failure to identify common hazards and follow industry standards of care during the operation of these refrigeration systems," said EPA New England Regional Administrator David W. Cash. "It's imperative that companies comply with Clean Air Act requirements in order to protect facility workers and surrounding communities. Particularly in rural areas, if a chemical accident occurs, it can take time for trained HazMat responders to arrive. We are pleased to say that, as a result of the Jasper Wyman & Son settlement's Supplemental Environmental Projects, the Cherryfield Fire Department will be better prepared to respond to chemical emergencies."
 
Earlier this month, Jasper Wyman & Son, a blueberry processing plant in Cherryfield, Maine, agreed to pay a penalty of $73,490 to resolve alleged violations of the Clean Air Act's chemical accident prevention requirements at its facility. In addition, the company agreed to provide training for local emergency responders on how to address ammonia releases and to donate equipment to the Cherryfield Fire Department to improve response capabilities under a Supplemental Environmental Project, valued at approximately $65,000.
 
Also, in the last year, Barber Foods, LLC, a Portland based company that manufactures frozen poultry products, agreed to pay a combined penalty of $300,000 for Risk Management Plan (RMP) violations at two of its facilities. Barber Foods agreed to pay a penalty of $149,000 for alleged violations at its Milliken Street plant and $151,000 for alleged violations at its St. John's Street facility. Barber Foods is in the Tyson Foods corporate family.
 
EPA inspections of all three facilities identified violations of the Clean Air Act's RMP requirements. In addition, the Jasper Wyman settlement includes allegations that the company failed to comply with the Clean Air Act's General Duty Clause for one refrigeration system that had less than 10,000 lbs. of ammonia. The three cases allege failures to identify, analyze and control certain hazards, failure to document compliance with certain good engineering practices, and equipment maintenance violations.
 
Background
 
All three of these facilities use anhydrous ammonia in their refrigeration systems. Anhydrous ammonia is an energy efficient refrigerant, but it must be handled with care because it is highly corrosive to the skin, eyes, and lungs. The chemical can cause serious, often irreversible health effects when released.
 
To prevent exposure to ammonia, it is important that ammonia refrigeration systems be designed to prevent the release of ammonia and minimize the effects of any release. This includes, among other things, providing for rapid detection of releases, safe shutdown of equipment, controlled containment of any releases, safe ventilation of such releases, and accessible eyewash/shower stations for employees and responders. Operators must also coordinate with emergency responders and have procedures in place for maintaining equipment and training employees.
 
EPA Releases Initial Nationwide Monitoring Data on 29 PFAS and Lithium
 
Today, the U.S. Environmental Protection Agency is releasing the first set of data collected under the fifth Unregulated Contaminant Monitoring Rule (UCMR 5). In the latest action to deliver on EPA’s PFAS Strategic Roadmap, UCMR 5 will provide new data that will improve EPA’s understanding of the frequency that 29 PFAS and lithium are found in the nation’s drinking water systems, and at what levels. The monitoring data on PFAS and lithium will help the Agency make determinations about future actions to protect public health under the Safe Drinking Water Act. This action advances the Biden-Harris Administration’s commitment to combat PFAS pollution and safeguard drinking water for all people.
 
“PFAS are an urgent public health issue facing people and communities across the nation. The latest science is clear: exposure to certain PFAS, also known as forever chemicals, over long periods of time is linked to significant health risks,” said Assistant Administrator for Water Radhika Fox. “That’s why the Biden-Harris Administration is leading a whole-of-government approach to address these harmful chemicals. As part of this commitment, EPA is conducting the most comprehensive monitoring effort for PFAS ever, at every large and midsize public water system in America, and at hundreds small water systems.”
 
The data collected under UCMR 5 will ensure science-based decision-making and help EPA better understand national-level exposure to these 29 PFAS and lithium, and whether they disproportionately impact communities with environmental justice concerns. This initial data release represents approximately 7% of the total results that EPA expects to receive over the next three years. The Agency will update the results quarterly and share them with the public in EPA’s National Contaminant Occurrence Database (NCOD) until completion of data reporting in 2026. EPA continues to conduct research and monitor advances in techniques that may improve our ability to measure these and other contaminants at even lower levels.
 
EPA is acting to protect peoples’ health from PFAS in drinking water. In March 2023, EPA proposed standards to limit certain PFAS in drinking water. The proposal, if finalized, would allow public water systems to use results from UCMR 5 to meet the rule’s initial monitoring requirements and to inform communities of actions that may need to be taken. In the interim period before the PFAS drinking water standard is final, EPA has established Health Advisories for four PFAS included in the UCMR 5. EPA continues to advance the science on the potential health effects of a wide range of PFAS, including many of those monitored for under this program.
 
EPA is moving forward to expand the investigation and cleanup of PFAS contaminated sites, including by finalizing new safeguards under Superfund to hold polluters accountable for contamination from two widely used PFAS chemicals. The Agency also recent issued its third order to require PFAS manufacturers to conduct testing under EPA’s National Testing Strategy to help EPA better confront these forever chemicals.
 
EPA is also deploying an unprecedented $9 billion, included in President Biden’s Bipartisan Infrastructure Law, specifically to invest in communities with drinking water impacted by PFAS and other emerging contaminants. This includes $4 billion via the Drinking Water State Revolving Fund (DWSRF) and $5 billion through EPA’s “Emerging Contaminants in Small or Disadvantaged Communities” grant program. States, Tribes and communities can further leverage an additional nearly $12 billion in BIL DWSRF funds and billions more in annual SRF funds dedicated to making drinking water safer. These funds will help communities make important investments in solutions to remove PFAS from drinking water.
 
 
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