EPA Proposes Designating Certain PFAS Chemicals as Hazardous Substances

September 06, 2022
Following through on the Biden-Harris Administration’s commitment to tackle environmental injustice and improve public health, the EPA is taking a significant action under Administrator Regan’s PFAS Strategic Roadmap to protect people and communities from the health risks posed by certain PFAS, also known as “forever chemicals.” EPA is proposing to designate two of the most widely used per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as “Superfund.” This rulemaking would increase transparency around releases of these harmful chemicals and help to hold polluters accountable for cleaning up their contamination. 
The proposal applies to perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, and is based on significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment. PFOA and PFOS can accumulate and persist in the human body for long periods of time and evidence from laboratory animal and human epidemiology studies indicates that exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver, and immunological effects. 
“Communities have suffered far too long from exposure to these forever chemicals. The action announced today will improve transparency and advance EPA’s aggressive efforts to confront this pollution, as outlined in the Agency’s PFAS Strategic Roadmap,” said EPA Administrator Michael S. Regan. “Under this proposed rule, EPA will both help protect communities from PFAS pollution and seek to hold polluters accountable for their actions.”  
Many known and potential sources of PFAS contamination are near communities already overburdened with pollution. If finalized, the rulemaking would trigger reporting of PFOA and PFOS releases, providing the Agency with improved data and the option to require cleanups and recover cleanup costs to protect public health and encourage better waste management. 
It would also improve EPA, state, Tribal nation, and local community understanding of the extent and locations of PFOA and PFOS contamination throughout the country and help all communities to avoid or reduce contact with these potentially dangerous chemicals.  
EPA is focused on holding responsible those who have manufactured and released significant amounts of PFOA and PFOS into the environment. EPA will use enforcement discretion and other approaches to ensure fairness for minor parties who may have been inadvertently impacted by the contamination. EPA is also committed to doing further outreach and engagement to hear from impacted communities, wastewater utilities, businesses, farmers and other parties during the consideration of the proposed rule. 
If this designation is finalized, releases of PFOA and PFOS that meet or exceed the reportable quantity would have to be reported to the National Response Center, state or Tribal emergency response commissions, and the local or Tribal emergency planning committees. A release of these or any other hazardous substance will not always lead to the need to clean up or add a site to the National Priorities List (NPL), liability or an enforcement action. EPA anticipates that a final rule would encourage better waste management and treatment practices by facilities handling PFOA or PFOS. The reporting of a release could potentially accelerate privately financed cleanups and mitigate potential adverse impacts to human health and the environment. 
Additionally, the proposed rule would, in certain circumstances, facilitate making the polluter pay by allowing EPA to seek to recover cleanup costs from a potentially responsible party or to require such a party to conduct the cleanup. In addition, federal entities that transfer or sell their property will be required to provide a notice about the storage, release, or disposal of PFOA or PFOS on the property and a covenant (commitment in the deed) warranting that it has cleaned up any resulting contamination or will do so in the future, if necessary, as required under CERCLA 120(h). 
EPA will be publishing the Notice of Proposed Rulemaking in the Federal Register in the next several weeks. Upon publication, EPA welcomes comment for a 60-day comment period. 
As a subsequent step, EPA anticipates issuing an Advance Notice of Proposed Rulemaking after the close of the comment period on the recent proposal to seek public comment on designating other PFAS chemicals as CERCLA hazardous substances.  
The recent actions represent a significant milestone within the Biden-Harris Administration’s commitments to combat PFAS pollution and safeguard drinking water, and specifically EPA’s October 2021 PFAS Strategic Roadmap. Under the Roadmap, EPA is working across the agency to protect the public from the health impacts of PFAS. EPA has taken a number of actions to deliver progress on PFAS including:  
  • Releasing drinking water health advisories for four PFAS – using the best available science to tackle PFAS pollution, protect public health, and provide critical information quickly and transparently
  • Making available $1 billion in grant funding through President Biden’s Bipartisan Infrastructure Law
  • Issuing the first Toxic Substances Control Act PFAS test order under the National PFAS Testing Strategy
  • Adding five PFAS Regional Screening and Removal Management Levels that EPA uses to help determine if cleanup is needed
  • Publishing draft aquatic life water quality criteria for PFOA and PFOS
  • Issuing a memo to proactively address PFAS in Clean Water Act permitting
  • Publishing a new draft total adsorbable fluorine wastewater method
  • Issuing the fifth Unregulated Contaminant Monitoring Rule to improve EPA’s understanding of the frequency that 29 PFAS are found in the nation’s drinking water systems and at what levels and preparing to propose a PFAS National Drinking Water Regulation by the end of 2022
IARC Releases Monograph on 1,1,1-Trichloroethane, Other Industrial Chemicals
The International Agency for Research on Cancer (IARC) has classified the industrial chemical 1,1,1-trichloroethane as a Group 2A carcinogen, the agency’s designation for substances that are probably carcinogenic to humans. IARC’s evaluation of research on 1,1,1-trichloroethane concluded that positive associations exist between exposure and the blood cancer multiple myeloma. The findings appear in a new edition of the agency’s monographs series. A previous IARC monograph published in 1998 had designated 1,1,1-trichloroethane as Group 3, or not classifiable as to its carcinogenicity to humans.
Although EPA categorizes 1,1,1-trichloroethane as a high-production volume chemical, which means that at least one million pounds of the substance are manufactured or imported into the United States per year, IARC notes that production volumes have dropped dramatically since adoption of the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer and the 1990 Clean Air Act. 1,1,1-Trichloroethane was widely used as a degreasing solvent in the 1970s and 1980s, and it was an ingredient in many household products such as adhesives, lubricants, glues, and fabric finishes. By the early 2000s, the chemical was used almost exclusively as a precursor in the manufacture of hydrofluorocarbons.
The potential for occupational exposures to 1,1,1-trichloroethane occurred in its manufacture as well as in industries that used it for cleaning furniture, metal products, and electronic equipment, and in industries where the chemical was used in the manufacturing of paints, inks, and aerosol and adhesive products. In 2001, ACGIH set a Threshold Limit Value for 1,1,1-trichloroethane of 350 ppm as an 8-hour time-weighted average and a 15-minute short-term limit of 450 ppm.
The new monograph also assesses 1,2-diphenylhydrazine, previously used globally as a precursor in the production of dyes; diphenylamine, a component of lubricants, greases, metalworking fluids, and other products; n-methylolacrylamide, which is used in the manufacture of polymers with acrylic and vinylic monomers; and isophorone, a widely used solvent and chemical intermediate. IARC classifies all four of these substances as Group 2B, possibly carcinogenic to humans.
The new volume of the IARC monographs series is freely available on the agency’s website.
EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products
The EPA is proposing to remove 12 chemicals identified as per- and polyfluoroalkyl substances (PFAS) from the current list of inert ingredients approved for use in pesticide products to better protect human health and the environment.
“Exposure to PFAS is an urgent public health and environmental issue in our country and we’re continuing to work aggressively to reduce the use of these dangerous chemicals,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. “Ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”
Under the PFAS Strategic Roadmap, EPA committed to taking a renewed look at previous PFAS decisions, and, as part of this review, undertook a thorough review of its list of chemical substances that have been approved for use as inert ingredients in pesticide products. EPA then used its authority to take quick action on PFAS inert ingredients not currently used in registered pesticide products. 
Pesticide products contain at least one active ingredient and other intentionally added inert ingredients. Inert ingredients play key roles in pesticide effectiveness and product performance including extending the product’s shelf life or improving the ease of application by preventing caking or foaming. EPA reviews safety information for inert ingredients before they can be included in a pesticide.
While these PFAS are no longer used in any registered pesticide products, EPA determined it is important to remove these 12 chemicals from the list of approved inert ingredients to allow for an updated review of available information for these chemicals to be required, if their future use in pesticide products is requested:
  • 2-Chloro-1,1,1,2-tetrafluoroethane (CAS Reg. No. 2837-89-0);
  • α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS Reg. No. 65530-85-0);
  • Dichlorotetrafluoroethane (CAS Reg. No. 1320-37-2);
  • Ethane, 1,1,1,2,2-pentafluoro- (CAS Reg. No. 354-33-6);
  • Hexafluoropropene, polymer with tetrafluoroethylene (CAS Reg. No. 25067-11-2);
  • Montmorillonite-type clay treated with polytetrafluoroethylene (No CAS Reg. No.);
  • Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS Reg. No. 131324-06-6);
  • Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS Reg. No. 79070-11-4);
  • Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS No. 163440-89-9);
  • Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2- propenyl)oxy]ethyl]- (CAS Reg. No. 65530-66-7);
  • Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS Reg. No. 65545-80-4); and
  • Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS Reg. No. 431-89-0).
Upon publication of the Federal Register notice, EPA will accept public comments on this proposal for 30 days in docket EPA-HQ-OPP-0542 at www.regulations.gov. If removed from the list, any proposed future use of these chemicals as inert ingredients will need to be supported by data which may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as data on environmental effects.
Pesticide registration decisions are based on extensive data requirements as outlined in 40 CFR 158 which applies to both active ingredients and the inert materials contained in end use products. EPA continues to evaluate all pesticide active ingredients to determine if any meet the current structural definition of PFAS or are part of other related chemistries that have been identified by stakeholders as being of concern. EPA will continue to provide updates as more information becomes available.
To read a prepublication version of this proposal and for more information on inert ingredients approved for use in pesticide products visit the Inert Ingredients Overview and Guidance page.
EPA Requires $179K Penalty and Compliance Actions to Fix Unsafe Practices at Chemical Storage and Processing Facility
The EPA recently reached a settlement with Greenfield Global USA, Inc., based in Brookfield, Conn., for alleged violations of both the Clean Air Act's General Duty Clause (CAA GDC) and the Emergency Planning and Community Right-to-Know Act (EPCRA). Under the settlement, the company has agreed to pay a penalty of $179,596 and certify compliance with all its CAA GDC and EPCRA requirements.
"It is unacceptable that chemical warehouses and distribution centers pollute the air our kids breathe and don't disclose their activities," said EPA New England Regional Administrator David W. Cash.
"Enforcement actions like this one send a strong message to these companies that deal with dangerous chemicals – they have an obligation to keep the public, and local emergency responders, informed about the chemicals they deal with and ensure they are stored safely in order to protect the communities they are located in."
Greenfield Global USA, Inc. (Greenfield) is a privately owned company that provides chemical repackaging, formulation, and storage services at its facility in Brookfield, Conn. Greenfield stores and processes numerous toxic chemicals at this facility for which it is required to annually report on its releases of the chemicals under EPCRA Section 313. The reports are filed in EPCRA's Toxic Release Inventory (TRI) database, which is available to the public. Greenfield also uses and stores chemicals that are considered extremely hazardous substances ("EHSs") and covered under the CAA's GDC, including chloroform, formaldehyde, and sulfuric acid.
The company's alleged violations were first documented during an EPA inspection at Greenfield's facility at 58 Vail Rd. EPA claims that the company failed to design and maintain a safe facility, which is necessary to prevent releases under CAA GDC requirements, and failed to properly submit nine reports regarding certain toxic chemicals to EPA's TRI database for the years 2017 and 2018. Greenfield was cooperative with EPA throughout the inspection and enforcement process.
The facility is located within a half-mile of several retail businesses, two highways, and a residential neighborhood. In addition, the neighboring community of Danbury has several environmental justice concerns, including proximity to hazardous waste and Risk Management Program facilities. The company's storage of hazardous chemicals at the facility had the potential to present a substantial risk to human health and the environment, due to the presence of carcinogenic and highly flammable substances.
This case is part of an initiative to improve safety and compliance at chemical warehouses. Through the initiative, EPA Region 1 has brought several civil and criminal cases against chemical warehouses and published information to assist with compliance.
Oregon DEQ Issued 16 Penalties in July for Environmental Violations
The Oregon Department of Environmental Quality issued 16 penalties totaling $277,503 in July for various environmental violations. A detailed list of violations and resulting penalties is at https://ordeq.org/enforcement.
Fines ranged from $4,148 to $67,925. Alleged violations include a painting company allowing dock stain to fall into the Columbia River, a mining and quarry facility discharging water to an irrigation canal, and a golf course discharging retention pond water into a nearby creek.
DEQ issued civil penalties to the following organizations:
  • AM DRI Willamette, LLC, $17,261, Portland, stormwater
  • Archer Daniels Midland Co., $6,558, Portland, stormwater
  • Cascade Development Properties - 4, LLC, $19,811, Estacada, stormwater
  • City of Gresham, $6,000, Gresham, stormwater
  • Enerfin Resources, $28,892, Mist, wastewater
  • Grant County, $4,148, John Day, underground storage tanks
  • Hartman & Sons Painting, $8,400, Camas, water quality
  • JAE, Inc., $11,817, Tualatin, air quality
  • Knife River Corporation NW, $20,822, Prineville, wastewater
  • Mid-Valley Gravel Company, $16,800, Philomath, stormwater
  • Oregon Oils Inc., $8,400, Portland, water quality
  • Swaggart Bros. Inc, $19,869, Boardman, stormwater
  • Umpqua Golf Management LLC, $14,400, Sutherlin, water quality
  • Waste Management of Oregon, Inc. (Newberg Transfer Station), $8,400, Newberg, land quality
  • Western Wire Works, Inc., $18,000, Portland, stormwater
  • Willamette Graystone LLC, $67,925, Wood Village, stormwater
Organizations or individuals must either pay the fines or file an appeal within 20 days of receiving notice of the penalty. They may be able to offset a portion of a penalty by funding a supplemental environmental project that improves Oregon’s environment. Learn more about these projects at https://ordeq.org/sep.
Penalties may also include orders requiring specific tasks to prevent ongoing violations or additional environmental harm.
Agri-Energy, LLC, to Pay $34,000 for Air Quality Violations, Failing to Keep Required Records
According to a Minnesota Pollution Control Agency (MPCA) enforcement investigation, Agri-Energy, LLC, exceeded air pollutant emissions and failed to keep required equipment testing and maintenance records. The violations occurred at the company’s ethanol production facility in Luverne, Minn.
The bulk of the violations stem from failed emission stack tests in July 2019, including:
  • Cooling cyclone exceeded very small particulate matter (PM2.5) by more than twice the permitted limit
  • Thermal oxidizer exceeded sulfur dioxide by seven times the permitted limit
  • Cracked corn dust collector exceeded small (PM10) and very small (PM2.5) particulate matter by more than four times the permitted limit
  • Dry FRAC dust collector exceeded small (PM10) and very small (PM2.5) particulate matter by more than 1 ½ times the permitted limit
In addition to paying a $34,000 civil penalty to the MPCA, Agri-Energy has completed a series of corrective actions, including:
  • Completed performance emission stack retests for PM10, and PM2.5, on their cracked corn dust collector and dry FRAC dust collector
  • Submitted a complete major amendment application to increase PM2.5 limits on their cooling cyclone, and sulfur dioxide limits on their thermal oxidizer
  • Submitted an updated operation and maintenance plan that includes the proper recording of daily visual emissions, weekly roadway, and periodic inspection records
New Reference Exposure Level Adopted for Chromium, Trivalent
The California Office of Environmental Health Hazard Assessment (OEHHA) is adopting new Reference Exposure Levels (RELs) for Chromium, Trivalent (Inorganic Water-Soluble Compounds) (Cr(III)) for use in the Air Toxics Hot Spots Program. RELs are airborne concentrations of a chemical that are not anticipated to result in adverse noncancer health effects for specified exposure durations in the general population, including sensitive subpopulations. The adopted RELs cover different types of exposure to Cr(III) in air: infrequent 1-hour exposures, repeated 8-hour exposures, and continuous long-term exposure.
OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health and Safety Code Section 44360(b)(2)). In response to this statutory requirement, OEHHA develops RELs for many air pollutants, including Cr(III). The Cr(III) RELs were developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for the Derivation of Noncancer Reference Exposure Levels” (OEHHA, 2008). The Cr(III) compounds will also be added to the list of Toxic Air Contaminants that may disproportionately impact children, pursuant to Health and Safety Code Section 39669.5(b)(1).  
A draft document for the Cr(III) RELs was released on January 8, 2021, to solicit public comment and was discussed at a virtual public workshop during the subsequent 45-day public review period. The document was revised to reflect public comments, and peer reviewed by the State’s Scientific Review Panel on Toxic Air Contaminants (SRP) in May 2021 before being finalized. The Cr(III) REL values are as follows:
  • Acute REL (for infrequent 1–hour exposures):  0.48 micrograms Cr(III) per cubic meter (0.48 µg Cr(III)/m3)
  • Chronic REL (for long–term exposures): 0.06 μg Cr(III)/m3
  • 8–Hour REL (for repeated 8–hour exposures):  0.12 μg Cr(III)/m3
Colorado Springs Employer Willfully Exposed Worker to Serious Injury when Cement Mixer Turned on with Worker Inside
A worker performing maintenance inside a cement mixer at a Colorado Springs concrete manufacturing company narrowly escaped fatal injuries when a co-worker turned the machine on. A U.S. Department of Labor investigation determined the company’s failure to comply with federal workplace safety standards nearly cost the worker their life.
Inspectors with OSHA learned Lindsay Precast, Inc. knew that federal law required the company to train workers on lockout/tagout and confined space entry procedures before maintenance on the mixer began. Following the March 2, 2022, incident, OSHA issued one willful citation for exposing workers to potential hazards by not developing and using procedures to control hazardous energy and not training employees on the related dangers.
OSHA also issued serious citations for other failures by the company, including:
  • Not training workers on permit-required confined space hazards and the safety procedures for entering these spaces
  • Failing to train workers on fall hazards and provide fall protection in elevated areas on and around the concrete mixer
  • Failing to periodically inspect their hazardous energy control procedures
  • Not training affected employees on the proper procedures for powering on and off devices requiring lockout/tagout devices
The citations and proposed penalties totaled $203,035. The company received citations for machine guarding violations following a worker’s injury in 2017, and for respiratory protection and electrical violations in 2019.
"Our investigation found Lindsay Precast, Inc. was well-aware they were required to ensure employees used hazardous energy control procedures, yet they failed to implement them," said OSHA Area Director Chad Vivian in Englewood, Colorado. "By sheer good fortune, a worker narrowly avoided much more serious, and potentially, fatal injuries, in an incident that would have never happened if the employer had followed federal requirements to de-energize and lockout the mixer to prevent the machine’s start-up."
Founded in 1961, Lindsay Precast, Inc. is a concrete manufacturer specializing in precast concrete products. Based in Colorado Springs, the company also has operations in Florida, North Carolina and Ohio. It ships its products throughout the U.S. and is a supplier of burial vaults and other concrete products for the U.S. Department of Veterans Affairs.
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