EPA Proposes Stronger Rules To Protect People from Persistent, Bioaccumulative, and Toxic Chemical Exposures

November 27, 2023
The U.S. Environmental Protection Agency (EPA) released a proposed rule to further protect people from exposure to two chemicals that are toxic, remain in the environment for long periods of time, and accumulate in the body. Both decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)) are persistent, bioaccumulative and toxic (PBT) chemicals that were subject to risk management rules under the Toxic Substances Control Act (TSCA).
EPA’s proposed rule would impose workplace safety protections and restrict water releases. It would also address broader implementation issues affecting the supply chains of various industry sectors including the nuclear energy sector, transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production.
“Persistent, bioaccumulative and toxic chemicals can remain in the environment and our bodies for long periods of time, which makes it particularly important that EPA ensures protections are in place for these chemicals,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Today’s proposed rule will better protect workers and communities from dangerous chemical exposures, while also ensuring that critical uses of these chemicals can continue safely.”
TSCA directed EPA to take expedited action on five PBT chemicals to reduce exposure and protect human health and the environment, and EPA finalized risk management rules in early January 2021. In February 2021, EPA announced that it would review actions taken under the previous Administration to ensure the Agency followed the science and the law. EPA also noted at that time that after the rules were finalized, manufacturers of a wide range of key consumer and commercial goods informed EPA that they were unable to meet compliance deadlines in the rules and warned of widespread economic disruption if changes were not made.
In March 2021, in light of Executive Orders and other guidance provided by the Biden-Harris Administration, EPA opened a public comment period to collect additional comments on whether the rules sufficiently reduced exposures to the PBT chemicals, on implementation issues associated with the PBT final rules, and on whether to consider additional or alternative measures. This rule proposes to amend two of those five rules. EPA is not proposing to revise the existing regulations for the other three PBT chemicals (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD) and pentachlorothiophenol (PCTP)) at this time.
DecaBDE is a flame retardant used in wire and cables for nuclear power generation facilities and multiple applications for aerospace and automotive vehicles including replacement parts. EPA has previously worked to reduce exposures from the larger class of flame retardants that include decaBDE, known as polybrominated diphenyl ethers. EPA has identified adverse human health effects associated with exposure to decaBDE, including damage to the development of the central nervous system and reproductive problems. Accordingly, EPA prohibited manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products or articles in its 2021 final rule, with a few exceptions.
This new proposed rule would require that workers use personal protective equipment (PPE) for some activities involving decaBDE not subject to the 2021 prohibitions, prohibit releases to water during manufacturing, processing, and distribution in commerce of decaBDE and decaBDE-containing products, and require entities intending to export decaBDE-containing wire and cable for nuclear power generation facilities to notify EPA.
The rule would also extend the compliance date for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities until after the service life of the wire and cable. This extended compliance date allows for the nuclear power generation industry to move to alternatives to decaBDE-containing wire and cable that play a vital role in the operation of numerous safety systems required by Federal regulations for both safe operation and safe shutdown of nuclear facilities. Nuclear facilities need qualified wire and cable to operate safely, and new types of wire and cable can take years to be certified consistent with the Nuclear Regulatory Commission regulations.
PIP (3:1)
PIP (3:1) is a plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive that has been used in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles. It is also used in key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. PIP (3:1) is toxic to aquatic plants, aquatic invertebrates, sediment invertebrates, and fish. EPA has identified adverse human health effects associated with exposure to PIP (3:1), including reproductive problems, neurological effects and damage to the liver, ovaries, heart and lungs.
Previously, EPA extended the compliance dates for articles containing PIP (3:1) to address the challenges that were inadvertently created by the original compliance dates in the January 2021 final rule to October 2024. Except for the exclusions and phase-outs for specific uses mentioned below, EPA is not proposing to further extend the October 2024 compliance date.
In this rule, EPA proposes to further extend the compliance dates for some articles used in manufacturing equipment and the semiconductor industry. The proposed rule also includes new worker protections, including a requirement that workers use PPE during manufacturing and processing of PIP (3:1).
EPA has also proposed phasing out some uses of PIP (3:1) that were excluded from the prohibitions in the February 2021 rule. For example, some uses of PIP (3:1) in lubricants and greases that were excluded from the prohibitions in the previous rule would be subject to a 5-year phaseout under this proposed rule. EPA is also proposing to exclude the processing and distribution of PIP (3:1) for use in wire harnessing and electric circuit boards from prohibition. 
In the coming weeks, EPA will host a public webinar for anyone looking for an overview of the proposed regulatory action. The date, time and registration information will be announced soon. EPA will accept public comments on the proposed rule for 45 days following publication in the Federal Register via docket EPA-HQ-OPPT-2023-0376 at www.regulations.gov.
Ingredion To Spend $8 Million in Settlement Over Clean Air Act Violations
Plant-based ingredient maker Ingredion Incorporated today agreed to a settlement with EPA and the U.S. Department of Justice, along with the Indiana Department of Environmental Management (IDEM) and the Indiana Attorney General’s Office, to settle claims that it violated the Clean Air Act (CAA) at its corn wet milling facility in Indianapolis. Ingredion will pay a civil penalty of $1,139,600 and implement measures at a cost of nearly $7 million to reduce and offset unpermitted emissions of particulate matter (PM) and to comply with lower future PM limits.
A complaint filed with the consent decree states that Ingredion violated CAA permit limits on PM emissions, including inhalable PMs with a diameter of 10 microns or less, and volatile organic compounds.  The complaint also states that Ingredion did not operate and monitor certain equipment as required to minimize air emissions.
“This settlement requires Ingredion to lower its emissions of particulate matter, which can cause serious health problems, and also requires Ingredion to take steps to offset the unlawful emissions it released in the past,” said Assistant Administrator David M. Uhlmann of EPA’s Office of Enforcement and Compliance Assurance.  “To help ensure the Company’s future compliance, Ingredion must implement a compliance management system that is subject to an independent audit program.”
“Today’s settlement will not just bring Ingredion back into compliance with the Clean Air Act, it will hold it to more stringent air pollution standards going forward,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division (ENRD). “This settlement will result in cleaner air for the residents of Indianapolis, particularly those who live in the overburdened community near the Ingredion facility.”
“IDEM is happy to be a part of this resolution that ensures responsible operations in compliance with the Clean Air Act,” said IDEM Commissioner Brian Rockensuess. “Good air quality is a shared resource that requires partnership between government entities, the public and industry. This settlement will benefit residents in Marion County and Hoosiers across Indiana.”
PM is composed of microscopic solids or liquid droplets. It can get deep into the lungs and cause serious health problems including coughing, aggravated asthma, chronic bronchitis and premature death in people with heart or lung disease.
The settlement requires Ingredion to install and operate new equipment to meet PM limits that are lower than the plant’s current permitted limits. The company completed installation and testing of the new system in advance of today’s filing. The settlement also requires Ingredion to implement a modernized compliance management system to address repeated operation and monitoring failures at the facility and hire an independent auditor to verify the effectiveness of the system.
Under today’s settlement, Ingredion committed to mitigating the harm associated with past excess PM emissions by paving onsite unpaved and partially paved roads and parking areas to reduce PM emissions generated by vehicle traffic, which Ingredion completed in advance of today’s filing. The company will also replace aging railway locomotives at the facility with two modern locomotives that meet emissions standards.
As a state supplemental environmental project, the settlement requires Ingredion to contribute $560,400 to the State of Indiana to support Brownfields redevelopment in and around Marion County, Indiana.
The EPA and IDEM are investigating the case.  Attorneys from the U.S. Department of Justice’s Environmental Enforcement Section and the Indiana Attorney General’s Office are handling the case.
Massachusetts Manufacturer Cited for Combustible Dust Violations After Fatal Explosion
A Newburyport pharmaceutical and chemical manufacturer and its parent company could have prevented an employee's fatal injuries from an explosion on May 4, 2023, but lacked the required safeguards in a chemical manufacturing process, a U.S. Department of Labor investigation found.
An investigation by the department's Occupational Safety and Health Administration at PolyCarbon Industries Inc./SEQENS SAS identified numerous deficiencies in the facility's process safety management program for highly hazardous chemicals for the production and drying of a chemical product called Dekon 139 and for combustible dust hazards. During the process, a pressure vessel exploded causing the employee's fatal injuries.
Specifically, OSHA investigators found that PolyCarbon/SEQENS did not:
  • Determine the combustibility hazards of materials used in the Dekon 139 production process, exposing employees to fire and explosion hazards from combustible dust.
  • Include safe upper and lower temperature limits to prevent the decomposition of Dekon 139.
  • Evaluate the consequences of deviation in the Dekon 139 production process.
  • Establish written procedures to maintain the ongoing integrity of process equipment and provide clear instruction on consequences of deviation from steps in the operating procedures.
  • Update the process safety information to include steps to avoid consequences of deviation in temperature, properties and hazards of the chemicals used in the process.
  • Update standard operating procedures for producing Dekon 139 and its safety data sheet.
  • Review a November 2022 compliance audit report with all affected personnel whose job tasks are relevant to the report findings.
  • Track contract employee's injury and illnesses related to the contractor's work in the process areas.
These conditions led OSHA to cite PolyCarbon Industries Inc./SEQENS SAS for 11 violations, including eight serious and two repeat and one other-than-serious. The agency assessed $298,254 in proposed penalties. View the citations.
"The requirements of OSHA's Process Safety Management standard are stringent and comprehensive because failure to comply fully can have a severe or catastrophic impact on employees that, in this case, cost a worker their life," said OSHA's Area Director Sarah Carle in Andover, Massachusetts. "Employers must rigorously, completely and continuously scrutinize, update and maintain each element of the process properly to identify and minimize hazards and protect workers' safety and health."
PolyCarbon Industries Inc./SEQENS SAS 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.
SEQENS SAS operates 24 manufacturing plants and three research and development centers in North America, Europe and Asia. Formerly named PCI Synthesis, the Newburyport site is a chemical-processing facility engaged in the manufacturing, drying, packaging and testing of active pharmaceutical intermediates and custom synthesized chemicals.
In the EU One in Three Checked Biocidal Products Found To Be Non-Compliant
The national enforcement authorities in 29 countries checked over 3 500 biocidal products. Overall, 37 % of the checked biocides were non-compliant with at least one of the checked legal requirements.
18 % of checked products were non-compliant with fundamental requirements that affect their safe use. Most of them either lacked a product authorisation or included non-allowed active substances. Most biocides with such major non-compliance were disinfectants, insecticides, and repellents/attractants. Inspectors found about 60 active substances that are not allowed in these products. All products that lacked authorisation or contained non-allowed active substances were withdrawn from the market. In some cases, criminal complaints or fines were issued.
The remaining 19 % non-compliant products were found to have minor deficiencies that did not affect safe use such as missing contact information of the supplier. In these cases the national enforcement authorities gave advice or administrative orders.
Much non-compliance was found in disinfectants sold to consumers. 265 disinfectants out of nearly 1 900 that were checked (14 %) were found to be non-compliant. This included serious compliance deficiencies such as lacking authorisation or incorrect labelling that usually led to the withdrawal of the disinfectants from the market.
The inspectors focused on disinfectants because new manufacturers entered the market with biocidal products at the early stages of the COVID-19 pandemic. Many of those disinfectants were not fully compliant with the EU’s Biocidal Products Regulation (BPR) and the related national transitional requirements for biocides.
This harmonised enforcement project on biocides checked how different types of biocidal products on the EU, EEA and Swiss markets comply with the Biocidal Products Regulation. The inspections focused on:
  • Non-allowed active substances in biocidal products
  • Approval of the active substance suppliers (Article 95);
  • Obligations related to labelling, packaging and advertising of biocidal products
The national enforcement authorities carried out the inspections during 2022. Where needed, controls also involved chemical analysis of biocidal products.
Electron Hydro To Pay $1 Million Clean Water Act Penalty for Artificial Turf, Tire Crumb Discharge
The U.S Environmental Protection Agency announced that Electron Hydro, LLC, and its Chief Operating Officer, Thom Fischer, have agreed to pay a $1,025,000 civil penalty for major violations of the Clean Water Act stemming from the illegal installation of thousands of yards of artificial turf at a construction project at the Electron dam and the subsequent release of hundreds of yards of the turf and the crumb rubber it contained into the Puyallup River in the summer of 2020.
Turf has been found at least 5000 feet from the site and crumb rubber has been found at least 19 miles downstream. Recovery of all the discharged material is not possible.
“Sadly, Electron Hydro’s and Mr. Fischer’s unfathomable violations will have lasting environmental impact on the Puyallup River and the fish and wildlife that rely on it,” said Ed Kowalski, Director of the Enforcement and Compliance Assurance Division in EPA’s Region 10 office in Seattle. “Payment of this major penalty cannot undo the damage. However, the additional work required by this settlement represents a significant step toward restoring our precious water resources and should serve as a strong reminder that EPA will exact significant sanctions, monetary and otherwise, from those who ignore their legal responsibilities to protect our water resources.”
Artificial turf contains a wide range of toxic compounds, including plasticizers, zinc, lead, and other toxic compounds. Crumb rubber is made from waste tires that contain 6PPD, a chemical used in tire manufacturing. When 6PPD reacts with ozone, it forms 6PPD-q, which is toxic to salmon, trout, and many other fish and aquatic species, and is known to be lethal to coho salmon.
The Puyallup River, which flows into Puget Sound, is home to Chinook salmon, bull trout, and steelhead trout, all of which are protected under the Endangered Species Act. The river is also home to coho, chum, and pink salmon, as well as cutthroat trout.
The Puyallup Tribe owns the bed and banks of the Puyallup River within its reservation and downstream of the discharge site. Since time immemorial, Tribal members have fished the waters of the Puyallup River, the Puyallup River Watershed, and Commencement Bay -- and the Tribe’s fishing rights are protected by treaty.
In its investigation, the EPA also discovered that for many years Electron Hydro violated the conditions of the Washington Department of Ecology’s Construction Stormwater General Permit by failing to:
  • Update its Notice of Intent to reflect the true size of the construction area;
  • Provide secondary containment for equipment containing fuel;
  • Implement and/or maintain required best management practices;
  • Adequately conduct and/or document inspections;
  • Maintain records on-site; and
  • Timely submit discharge monitoring reports.
The company’s failure to comply with the conditions of the permit may have resulted in environmental harm due to discharge of pollutants such as sediment, phosphorus, and petroleum products from the construction site to the Puyallup River.
In November 2020, the U.S. Department of Justice filed a complaint in federal court. After multiple successful rulings in federal court, the EPA and the Department of Justice negotiated a Clean Water Act settlement with Electron Hydro and Fischer, which is memorialized in the Consent Decree announced today. In addition to paying a penalty of $1,025,000, the company and Fischer agreed to perform a significant amount of injunctive relief that will directly benefit the Puyallup River and/or redress the harms from their Clean Water Act violations. Specifically, they agree to:
  • Implement comprehensive turf management requirements to ensure as much turf as possible is recovered from the environment, including establishing a phone line and web reporting tools for members of the public to report artificial turf observed;
  • Hire an independent third-party contractor to evaluate operations covered by the Construction Stormwater General Permit and implement all recommended stormwater best management practices and publish stormwater compliance information to a public website for transparency and accountability;
  • Preserve in perpetuity approximately 70 acres of land along the Puyallup River that provide valuable salmon habitat;
  • Hire an independent third-party contractor to evaluate the company’s new plans to complete the failed 2020 construction project and submit the contractor’s evaluation to the U.S. Army Corps of Engineers; and
  • Forgo hydroelectric operations until they remove thousands of yards of rock placed in the river in October 2020.
Coffeyville Resources Refining Will Pay Over $23M To Address Clean Air Act Violations
The U.S. Environmental Protection Agency (EPA) and U.S. Department of Justice today announced a settlement with Coffeyville Resources Refining & Marketing LLC and its affiliated companies (CRRM) for violations of the Clean Air Act and a previous consent decree related to operation of its petroleum refinery in Coffeyville, Kansas.
These violations resulted in illegal emissions of various pollutants, including an EPA estimate of over 2,300 excess tons of sulfur dioxide (SO2), a pollutant that can make breathing more difficult, from the refinery’s flares from 2015 to 2017.
The United States and the State of Kansas allege that CRRM violated numerous provisions of a 2012 consent decree and the Clean Air Act. Under the settlement, CRRM will spend at least $1 million on a project to benefit the public and environment of Kansas and implement measures costing up to $9 million to prevent future violations and redress the environmental harm caused by their unlawful conduct. The company will also pay more than $13 million in penalties to the United States and Kansas.
“The settlement with Coffeyville delivers on the promise of EPA’s new climate enforcement strategy by reducing greenhouse gas emissions equivalent to the annual emissions of 10,000 cars,” said Assistant Administrator David M. Uhlmann for EPA’s Office of Enforcement and Compliance Assurance. “In addition, the actions we are taking alongside our state partners in Kansas will reduce harmful air pollution that makes breathing more difficult and causes smog, acid rain, and tree and plant damage.”
“This settlement demonstrates that the United States will take decisive action to address Clean Air Act violations, to enforce the terms of consent decrees, and to promote environmental justice,” said Assistant Attorney General Todd Kim of the Justice Department’s Environment and Natural Resources Division (ENRD). “The emissions reductions achieved under this settlement will result in healthier air for a community disproportionately affected by air pollution, including for residents of the nearby Cherokee Nation.”
“We are committed to protecting people and families in the communities where they live,” said EPA Region 7 Administrator Meg McCollister. “In addition to the emission controls provided in the settlement, this order requires CRRM to invest $1 million in an environmental project to be approved by the State of Kansas, which will directly benefit the citizens of the state.”
Since the United States and Kansas began investigating CRRM’s alleged non-compliance in 2016, CRRM’s efforts to come into compliance with Clean Air Act requirements have already eliminated more than 39,000 tons per year of carbon dioxide (CO2) emissions from excessive flaring of waste gas, equivalent to using nearly 4 million fewer gallons of gasoline per year. In addition, EPA estimates that the flare gas recovery system required by the consent decree lodged today will further reduce yearly emissions of greenhouse gases by 12,888 tons, equivalent to using 1.3 million fewer gallons of gasoline annually, and will also reduce yearly emissions of SO2 by 1.7 tons and nitrogen oxide (NOx) by 9.57 tons. NOx is a primary contributor to the formation of smog.
In 2020, the United States and Kansas sought more than $6.8 million in stipulated penalties from CRRM because of the company’s alleged violations of the 2012 consent decree, primarily regarding its failure to properly monitor SO2 emissions from flaring. Various refinery processes lead to flaring or burning of waste gases which emit various pollutants into the atmosphere, including carbon dioxide, methane, and SO2. The U.S. District Court for the District of Kansas held CRRM liable for the stipulated penalties and the company appealed the decision.
Also in 2020, the United States and Kansas alleged additional Clean Air Act violations at the refinery, resulting in excess emissions of SO2 in a community already disproportionately impacted by air pollution. Exposure to SO2 can harm breathing and particularly affects those with asthma, children, and older adults. High concentrations of SO2 can lead to the formation of other sulfur oxides and ultimately small particles, which can contribute to particulate matter pollution, acid rain, and tree and plant damage.
The consent decree, which the United States filed today, resolves the stipulated penalties demand and violations identified in the complaint. CRRM must:
  • Pay over $6.8 million in stipulated penalties awarded by the court and $183,000 in stipulated penalties for additional violations of the 2012 consent decree.
  • Pay over $6.2 million in additional penalties for Clean Air Act violations alleged in the complaint.
  • Spend at least $1 million on an environmentally beneficial project to be approved by the State of Kansas.
  • Undertake various measures to facilitate future compliance with the Clean Air Act.
  • Reduce NOx emissions from refinery heaters.
  • Build an approximately $9 million flare gas recovery system to reduce the refinery’s flaring.
EPA Region 7, EPA’s Office of Enforcement and Compliance Assurance, and the Kansas Department of Health and Environment investigated the case. The Department of Justice’s ENRD Environmental Enforcement Section and the State of Kansas prosecuted the case.
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