EPA Finalizes Changes to Strengthen Implementation of Toxic Substances Control Act

February 12, 2024
The EPA finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule that will strengthen the agency’s ability to successfully implement the law in a sustainable way, will improve the efficiency of EPA’s chemical reviews, and ensure these reviews result in necessary health and safety protections. The amendments update how EPA will recover authorized costs of the law’s implementation and ensure that collected fees provide the Agency with 25% of authorized costs consistent with direction from Congress.
The 2016 amendments to TSCA greatly increased EPA’s authority and responsibility to protect people and the environment from toxic chemicals. While Congress provided EPA with new authority to collect fees to offset up to 25% of authorized TSCA implementation costs, the 2018 TSCA Fees Rule resulted in collection of less than half of the costs EPA had the authority to collect, adding to implementation challenges caused by insufficient resources.
“Under the Biden-Harris Administration, we’ve made incredible progress implementing our nation’s chemical safety law, and today is another major step forward as we work to build a more sustainable, efficient program that protects public health,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “This final rule will provide more resources, allowing EPA to review more chemicals more efficiently which means better and faster protections for communities from dangerous chemicals and robust support for American innovation of new chemistries.”
Reports from EPA’s Office of Inspector General and the U.S. Government Accountability Office note EPA’s lack of resources for the TSCA program and the impact it has had on implementing the 2016 law, as well as the need for better cost estimates. Additionally, EPA’s October 2022 report to Congress on the agency’s capacity to implement the 2016 law acknowledges compounding failures on the EPA’s part in the first few years following enactment to adequately assess its resource needs early and to establish fees that capture the updated cost of EPA’s TSCA work.
EPA based its November 2022 proposed rule on its comprehensive 2021 analysis that more adequately accounted for the anticipated costs of implementing the amended law based on data from the first several years of implementation.
In today’s final rule, EPA has reduced the total program cost estimate by over 19% to approximately $146.8 million (compared to approximately $181.9 million in the 2022 proposed rule) as a result of its comprehensive budget analysis. EPA has identified numerous efficiencies through its experience implementing TSCA that have brought down the estimated costs. Some of these efficiencies include more targeted data reviews and analyses refinement. In addition, EPA will likely need to spend less money gathering data on the next set of chemicals being prioritized for risk evaluation.
Specifically, the fees associated with EPA-initiated risk evaluations have been reduced from $5.1 million to $4.3 million, and the fees for review of a new chemical submissions have been reduced from $45,000 to $37,000.
The final rule will be effective 60 days after publication in the Federal Register.
Read the final rule.
EPA Finalizes Stronger Standards for Harmful Soot Pollution
The Biden-Harris Administration on Wednesday finalized a significantly stronger air quality standard that will better protect America’s families, workers, and communities from the dangerous and costly health effects of fine particle pollution, also known as soot. By strengthening the annual health-based national ambient air quality standard for fine particulate matter (PM2.5) from a level of 12 micrograms per cubic meter to 9 micrograms per cubic meter, the EPA’s updated standard will save lives — preventing up to 4,500 premature deaths and 290,000 lost workdays, yielding up to $46 billion in net health benefits in 2032. For every $1 spent from this action, there could be as much as $77 in human health benefits in 2032.
Today’s action is based on the best available science, as required by the Clean Air Act, and sets an air quality level that EPA will help states and Tribal Nations achieve over the coming years — including through complementary EPA standards to reduce pollution from power plants, vehicles, and industrial facilities, paired with historic investments under President Biden’s Inflation Reduction Act and the Bipartisan Infrastructure Law. These actions bolster the U.S. economy by deploying billions of dollars and creating good-paying jobs across the transition to cleaner technologies. This strategy will make Americans healthier and more productive, while underpinning a manufacturing resurgence in America. Since 2000, PM2.5 concentrations in the outdoor air have decreased by 42% while the U.S. Gross Domestic Product increased by 52% during that time.
“This final air quality standard will save lives and make all people healthier, especially within America’s most vulnerable and overburdened communities,” said EPA Administrator Michael S. Regan. “Cleaner air means that our children have brighter futures, and people can live more productive and active lives, improving our ability to grow and develop as a nation. EPA looks forward to continuing our decades of success in working with states, counties, Tribes, and industry to ensure this critical health standard is implemented effectively to improve the long-term health and productivity of our nation.”
Along with strengthening the primary annual PM2.5 standard, EPA is modifying the PM2.5 monitoring network design criteria to include a factor that accounts for proximity of populations at increased risk of PM2.5-related health effects to sources of air pollution. This will advance environmental justice by ensuring localized data collection in overburdened areas to inform future NAAQS reviews.
Particle pollution is of great concern to those with heart or lung disease and other vulnerable communities, including children, older adults, and people with health conditions like asthma, as well as already overburdened communities, including many communities of color and low-income communities throughout the United States. Strengthening the Clean Air Act standard for fine particle pollution improves air quality nationally for everyone, ensuring that communities that are overburdened by pollution are not left behind.
“The Biden administration is taking life-saving action to protect people and rein in deadly pollution,” said Abigail Dillen, President of Earthjustice. “The science is crystal clear. Soot, otherwise known as fine particle pollution, is a killer. It is driving heart disease, our asthma epidemic, and other serious illnesses. The people who suffer most are children and older Americans who live in communities of color and low-income communities. This federal standard will ensure that states respond to the ongoing public health and environmental justice crisis, saving thousands of lives and avoiding 800,000 asthma symptom cases every year.”
“Administrator Regan and President Biden deserve thanks for taking this vital step to curb soot pollution - a dangerous and even deadly pollutant that has taken an oversized toll on underrepresented and overburdened communities less equipped to deal with its severe health impacts,” said Dr. Doris Browne, 118th President of the National Medical Association. “This new standard of 9 micrograms per cubic meter will save lives based on scientific evidence. That is the bottom line. And as a physician, an advocate for clean air, and the past president of the National Medical Association representing physicians, our ultimate goal is health equity.”
“Particle pollution is a killer. In the United States alone, it cuts thousands of lives short, taking a staggering toll. Children’s bodies are uniquely vulnerable to the harms of soot pollution,” said Dominique Browning, Director and Co-Founder of Moms Clean Air Force.1 “Moms Clean Air Force commends EPA for taking a significant step forward in strengthening the annual standard for particle pollution, also known as soot, to 9 micrograms per cubic meter from its current level at 12. EPA’s new national health standard for particle pollution is the first improvement in over a decade. Soot is associated with increased infant mortality, hospital admissions for heart and lung diseases, cancer, and increased asthma severity. EPA’s finalized protection is an important step towards cleaner, healthier air for all children.”
In June 2021, EPA announced it would reconsider the December 2020 decision to retain the 2012 standards because the available scientific evidence and technical information indicated that the standards may not be adequate to protect public health and welfare. EPA considered the available science and technical information, as well as the recommendations of the independent advisors comprising the Clean Air Scientific Advisory Committee and CASAC PM expert panel when making the decision on whether to strengthen the PM standards.
Based on the scientific evidence, technical information, recommendations from CASAC, and public comments on the 2023 proposed standards, EPA has set two primary standards for PM2.5, which work together to protect public health: the annual standard, which EPA has revised, and a 24-hour standard, which the agency retained. EPA also retained the current primary 24-hour standard for PM10, which provides protection against coarse particles. EPA is also not changing the secondary (welfare-based) standards for fine particles and coarse particles at this time.
A broad and growing body of science links particle pollution to a range of serious and sometimes deadly illnesses. Many studies show that these microscopic fine particles can penetrate deep into the lungs and that long- and short-term exposure can lead to asthma attacks, missed days of school or work, heart attacks, expensive emergency room visits and premature death.
Due to the efforts that states, Tribes, industry, communities, and EPA have already taken to reduce dangerous pollution in communities across the country, 99% of U.S. counties are projected to meet the more protective standard in 2032, likely the earliest year that states would need to meet the revised standard. That’s even before accounting for additional actions on the horizon to implement the Bipartisan Infrastructure Law and Inflation Reduction Act investments and to update source-specific emission standards.
OSHA Updates Enforcement Document for Process Safety Management Standard
A new OSHA directive outlines the agency’s enforcement policy for its standard on the process safety management of highly hazardous chemicals. The document is primarily intended to help OSHA personnel understand the agency’s technical interpretations of the standard and is not a regulation or substantive rule. The new instruction, which became effective on Jan. 26, cancels and supersedes the previous enforcement directive from 1994. According to OSHA, significant updates to the enforcement document include the removal of an inspection checklist and the addition of a question-and-answer format outlining existing OSHA policies on process safety management. These updates are based on suggestions stemming from OSHA’s “lookback review” of its process safety management standard. Lookback reviews are intended to help OSHA “determine whether [existing] standards should be maintained without change, rescinded or modified.”
The questions and responses in the new OSHA instruction include references to applicable letters of interpretation or standard interpretations as well as current agency compliance guidance. OSHA addresses topics such as process hazard analysis, training, contractors, and mechanical integrity. Hot work permits, management of change, emergency planning and response, and compliance audits are also discussed.
The new OSHA directive is available as a PDF.
In 2022, OSHA announced that it was considering changes to the scope and provisions of its process safety management standard, but according to the regulatory agenda for the Department of Labor, the rulemaking remains in the pre-rule stage. Potential changes include resuming enforcement for oil and gas production facilities; expanding requirements for reactive chemical hazards; updating the standard’s list of highly hazardous chemicals; and expanding the scope of the standard to include oil- and gas-well drilling and servicing. Other changes could strengthen employee participation, require safer technology and alternatives analysis, and cover the mechanical integrity of critical equipment. A stakeholder meeting on this topic took place in October 2022, and recordings of the meeting are available from OSHA’s process safety management page.
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Heat Illness Claims Life of Alabama Construction Worker
During the peak of summer in July 2023, a 33-year-old concrete finisher collapsed at a Huntsville construction site after showing clear signs of heat illness, a tragedy that federal safety investigators found could have been prevented had the employer followed established safety practices for heat hazards.
An investigation by OSHA into the July 28, 2023, fatality found workers of SJ&L General Contractor LLC were hand forming concrete curbs when – as the heat index neared 107 degrees and humidity climbed to 85 percent – the worker was seen by coworkers stumbling, talking incoherently and eventually vomiting before becoming unresponsive. Though employees provided first aid and paramedics transported the worker to the hospital, the worker died only two hours after being admitted.
OSHA investigators determined that SJ&L General Contractor LLC exposed this worker and 18 other employees to hazards of extreme heat while working outside in direct sun during their 10-hour shifts.
“Had the employer ensured access to shade and rest in this brutal heat, this worker might not have lost their life and would have been able to end their shift safely,” said OSHA Area Office Director Joel Batiz in Birmingham, Alabama. “Regardless of the season – summer or winter – employers must establish rest cycles, train workers in identifying signs and symptoms of weather exposure, ensure workers have time to acclimate to temperatures, and implement and follow safety plans and ensure those plans are monitored. If not, weather conditions can have severe – and sadly, sometimes fatal – consequences, as they did in this case.”
OSHA determined SJ&L General Contractor LLC exposed workers to hazards associated with high heat while working in direct sunlight. The employer faces $16,131 in proposed penalties, an amount set by federal statute.
Increasing summer temperatures continue to impact workers. Fatalities due to exposure to extreme temperatures increased 18.6 percent in 2022, rising to 51 from 43 in 2021. Fatalities specifically due to environmental heat were 43 in 2022, up from 36 in 2021.
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.
OSHA has a number of resources that can assist employers and help workers stay safe while working in outdoor and indoor heat environments, including a heat safety tool that allows employers and workers to calculate the heat index and risk level to workers and follow protective measures to maximize safety.
Also, as the winter gets underway throughout the nation, OSHA urges employers to visit the agency’s winter safety page to understand the dangers of cold-weather hazards in the workplace and view resources to help recognize and reduce risks by planning, equipping and training workers.
Settlement Reached with Greenidge Generation LLC on Compliance with Coal Ash Regulations
The EPA announced a settlement under the Agency’s Coal Ash (Coal Combustion Residuals) program with the Greenidge Generation LLC, an electrical generating plant in Dresden, New York. This settlement, the first under EPA’s National Enforcement and Compliance Initiatives, commits Greenidge to address groundwater monitoring issues and to ensure the proper closure of a coal ash surface impoundment under the Resource Conservation and Recovery Act. The company will also pay a fine of $105,000.
Produced primarily from the burning of coal in coal-fired power plants, coal ash, also referred to as Coal Combustion Residuals (CCR), is a large industrial waste stream by volume and can contain harmful levels of contaminants such as mercury, cadmium, arsenic, and cobalt. Prior to 2015, the management and disposal of coal ash was not regulated at the national level; instead, it was regulated to varying degrees, if at all, by some states under various programs.  Historic disposal occurred through placement in unlined surface impoundments and landfills.  Without proper containment and management, contaminants from coal ash can pollute waterways, groundwater, drinking water, and the air.
“Coal ash contamination wreaks havoc on the environment and drinking water systems, particularly in overburdened communities,” said David M. Uhlmann, Assistant Administrator for EPA’s Office of Enforcement and Compliance Assurance. “EPA is committed to ensuring that coal ash surface impoundments and landfills operate and close in a manner that protects public health and the environment. This settlement is an important step forward in the federal government’s nationwide effort to ensure coal burning plants clean up the harmful effects of the toxic waste they produce.”
“EPA is working to ensure that companies comply with environmental regulations designed to protect public health, our lands and water resources,” said EPA Region 2 Regional Administrator Lisa F. Garcia. “This settlement requires Greenidge to cease using, and close, its surface impoundment and to monitor groundwater at the facility to protect surrounding communities and determine whether further steps are required.”
Greenidge burns natural gas to generate electricity for its bitcoin mining operation, and also provides energy to the state’s electricity grid.
EPA alleges that Greenidge did not meet certain requirements under the coal ash program, including:
  • Failure to comply with certain groundwater monitoring system requirements.
  • Failure to adequately prepare annual groundwater monitoring and corrective action reports.
  • Failure to timely prepare initial closure and post closure plans for its coal ash impoundment.
The settlement requires Greenidge to assess groundwater contamination from the coal ash impoundment at its facility. Greenidge will conduct groundwater sampling and analysis, evaluate groundwater flow to determine if additional wells are needed, and update and implement a closure plan for the coal ash impoundment. Ultimately, if groundwater monitoring reveals contamination above the federal groundwater protection standards, Greenidge will be required by self-implementing regulation to design and implement a corrective action program to address the contamination.
To address the risks from disposal and discharge of coal ash, including leaking of contaminants into groundwater, blowing of contaminants into the air as dust, and the catastrophic failure of coal ash surface impoundments, in April 2015, EPA established national rules for coal ash management and disposal.  These rules establish a comprehensive set of requirements for the safe handling and disposal of coal ash from coal-fired power plants, which established technical requirements for coal ash landfills and surface impoundments.
EPA is increasing its efforts and working with its state partners to investigate compliance concerns at coal ash facilities around the nation to ensure compliance and protect the health of communities overburdened by pollution such as coal ash residuals.
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