Final Rule Outlines Changes to EPA's Risk Evaluation Process

May 06, 2024
A new rule finalized by EPA will codify changes to the agency’s process for conducting chemical risk evaluations under the Toxic Substances Control Act (TSCA). According to EPA, the rule includes clarifications intended to ensure that it “appropriately considers risks to all workers in its risk evaluations.” For example, the agency will not assume that workers always use personal protective equipment when conducting its chemical risk evaluations, although EPA acknowledges that many employers take action to protect their employees. EPA previously adopted this approach in 2021 and has incorporated it into its TSCA risk evaluation activities in recent years. The agency will also consider “reasonably available information” such as circumstances where subpopulations of workers are exposed to a chemical substance due to a lack or ineffective use of PPE, a pre-publication copy of the final rule (PDF) explains.
The rule will also formalize EPA’s revised approach to risk determination. Rather than determining risk based on each “condition of use” for a chemical substance, the agency will make a single determination regarding whether a substance presents an “unreasonable risk” to human health or the environment. When EPA determines unreasonable risk associated with a chemical substance, the agency says it will identify the conditions of use that “significantly contribute” to its determination.
Additional changes codified under the final rule include a requirement that risk evaluations not exclude any conditions of use or exposure pathways as well as new procedures and criteria regarding whether and how EPA will revise its scope and risk evaluation documents. The agency also describes its plan to consider “real-world exposure scenarios,” including multiple exposure pathways to the same chemical substance and combined risks from multiple chemicals, when it has the information to do so. EPA’s news release states that these scenarios “may be particularly important for communities who face greater exposures or susceptibilities to chemicals than the rest of the general population.”
EPA will apply the procedures from the final rule to all risk evaluations initiated 30 days after the rule is published in the Federal Register or later. The agency intends to apply its new procedures to risk evaluations that are currently in process “to the extent practicable.”
EPA Issues Consent Order to MAX Environmental Technologies over RCRA Compliance
Max Environmental Technologies, Inc. (MAX) has agreed to several actions to ensure compliance with federal and state hazardous waste safeguards at the company’s waste facility in Yukon, PA, the U.S. EPA announced recently.
MAX owns and operates a 160-acre facility, surrounded by agricultural and residential properties, about 30 miles southeast of Pittsburgh, PA in Westmoreland County. According to EPA, this site is an area with potential environmental justice concerns. MAX conducts waste operations under permits issued by the Pennsylvania Department of Environmental Protection (PA DEP) pursuant to the federal Clean Water Act (CWA) and the Resource Conservation Recovery Act (RCRA). RCRA is the principal federal hazardous waste storage and disposal statute.
Among the hazardous wastes at the MAX facility are wastewater treatment sludge, corrosives, arsenic, barium, cadmium, chromium, lead, selenium, silver, electric arc furnace dust, and waste acid/pickle liquor.  Waste management units include five closed impoundments, an active solid waste landfill, waste storage tanks and containers, hazardous waste treatment units, and a leachate management system that generates sludge from wastewater treatment.
EPA officials inspected the facility in March 20-24, 2023, to determine MAX’s compliance with environmental regulations, including the terms of its PA DEP-issued CWA and RCRA permits. According to EPA, its inspectors documented several RCRA permit violations, including but not limited to: (1) unlawful disposal of hazardous waste in the solid waste landfill at the facility, (2) failure to maintain a containment building, and (3) failure to keep the hazardous waste containers closed to prevent hazardous waste release.
The Consent Order announced recently addresses RCRA and state hazardous waste requirements.  MAX has agreed to immediate measures to eliminate the potential release of solid and hazardous waste into the environment and to ensure that future ongoing operations do not cause or contribute to releases at the facility.   The RCRA consent order requirements include, but are not limited to:  
  • Prohibition of disposal of untreated and treated hazardous waste in the facility’s landfill unless it has been reviewed and analyzed by a third-party auditor and unaffiliated PA DEP-accredited laboratory.
  • Retention of an EPA approved third party Professional Engineer to perform a structural evaluation and recommendations to repair or modify the containment and processing building and containment pads.
  • Monitoring and sampling of residential wells adjacent to the facility.
  • Monthly progress reports and meetings with EPA project managers to evaluate the compliance actions stated in the Consent Order
EPA worked closely with PA DEP in investigating conditions and negotiating this consent order that addresses compliance with RCRA and state hazardous waste compliance.  EPA and PA DEP are currently reviewing MAX’s compliance with its CWA permit. 
Biden-Harris Administration Finalizes Ban on Most Uses of Methylene Chloride
The EPA finalized a ban on most uses of methylene chloride, a dangerous chemical known to cause liver cancer, lung cancer, breast cancer, brain cancer, cancer of the blood, and cancer of the central nervous system, as well as neurotoxicity, liver harm and even death. Ending most uses of methylene chloride will save lives and complements President Biden’s Cancer Moonshot, a whole-of-government initiative to end cancer as we know it.
EPA’s final action, also known as a risk management rule under the Toxic Substances Control Act (TSCA), will protect people from health risks while allowing key uses to continue safely with a robust new worker protection program. This is the second risk management rule to be finalized using the process created by the 2016 TSCA amendments.
“Exposure to methylene chloride has devastated families across this country for too long, including some who saw loved ones go to work and never come home,” said EPA Administrator Michael S. Regan. “EPA’s final action brings an end to unsafe methylene chloride practices and implements the strongest worker protections possible for the few remaining industrial uses, ensuring no one in this country is put in harm’s way by this dangerous chemical.”
“The USW applauds EPA’s final rule banning certain uses of methylene chloride and lowering allowable workplace exposure levels. More than 100,000 workers die from occupational disease each year, including those sickened by harmful chemical exposures. Our union fought for the updated Toxic Substances Control Act so that we could ensure that worker exposures to harmful substances like methylene chloride are appropriately assessed and regulated at harmful levels. Now, thanks to the current administration, workers are safer and better protected,” said David McCall, International President, United Steelworkers.
“Today’s announcement to ban most commercial uses of the toxic chemical methylene chloride in paint strippers is a significant step to protect more workers from this deadly chemical,” said Sarah Vogel, Senior Vice President for Healthy Communities at Environmental Defense Fund. “We are honored to stand beside the Hartley family, who has bravely shared their story to encourage this long overdue action that will save lives.”
Methylene chloride is used by consumers for aerosol degreasing and paint and coating brush cleaners, in commercial applications such as adhesives and sealants, and in industrial settings for making other chemicals. For example, methylene chloride is used in the production of more climate-friendly refrigerant chemicals.
Since 1980, at least 88 people have died from acute exposure to methylene chloride, largely workers engaged in bathtub refinishing or other paint stripping, even, in some cases, while fully trained and equipped with personal protective equipment. While EPA banned one consumer use of methylene chloride in 2019, use of the chemical has remained widespread and continues to pose significant and sometimes fatal danger to workers. EPA’s final risk management rule requires companies to rapidly phase down manufacturing, processing and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, including its use in home renovations. Consumer use will be phased out within a year, and most industrial and commercial uses will be prohibited within two years.
EPA’s methylene chloride rulemaking also establishes landmark worker protections under the nation’s premier chemical safety law. For a handful of highly industrialized uses, EPA has created a Workplace Chemical Protection Program. This workplace chemical protection program has strict exposure limits, monitoring requirements, and worker training and notification requirements that will protect workers from cancer and other adverse health effects caused by methylene chloride exposure.
Uses that will continue under the Workplace Chemical Protection Program are highly industrialized and important to national security and the economy. These are uses for which EPA received data and other information that shows workplace safety measures to fully address the unreasonable risk could be achieved. These uses include:
  • Use in the production of other chemicals, including refrigerant chemicals that are important in efforts to phase down climate-damaging hydrofluorocarbons under the bipartisan American Innovation and Manufacturing Act.
  • Production of battery separators for electric vehicles.
  • Use as a processing aid in a closed system.
  • Use as a laboratory chemical.
  • Use in plastic and rubber manufacturing, including polycarbonate production.
  • Use in solvent welding.
Additionally, specific uses of methylene chloride required by the National Aeronautics and Space Administration, the Department of Defense, and the Federal Aviation Administration will also continue with strict workplace controls because sufficient reductions in exposure are possible in these highly sophisticated environments, minimizing risks to workers.
For uses of methylene chloride continuing under the Workplace Chemical Protection Program, most workplaces will have 18 months after the finalization of the risk management rule to comply with the program and would be required to periodically monitor their workplace to ensure that workers are not being exposed to levels of methylene chloride that would lead to an unreasonable risk. In consideration of public comments on the proposal, EPA extended the compliance timeframe to give workplaces ample time to put worker protections in place. EPA also revised several other aspects from the proposal including ensuring the Workplace Chemical Protection Program applies to the same uses whether they are federal or commercial uses, establishing a de minimis concentration, and provisions to strengthen and clarify aspects of the Workplace Chemical Protection Program such as monitoring requirements.
Enforcement Actions Taken Against San Francisco for Violations of the Clean Water Act
The Department of Justice, on behalf of the EPA, and the Attorney General of California, on behalf of the San Francisco Bay Regional Water Quality Control Board, filed a civil complaint in federal court against the City and County of San Francisco for claims of Clean Water Act violations spanning the last decade. The complaint seeks financial penalties and improvements to remedy San Francisco’s repeated and widespread failures to operate its two combined sewer systems and three sewage treatment plants in compliance with the Clean Water Act and its permits. San Francisco failed to operate its combined sewer systems in a manner that keeps untreated sewage out of San Francisco Bay and its tributaries, streets, beaches and other areas with risk of human contact.
“Protecting San Francisco Bay, the Pacific Ocean and public health are critical priorities for EPA, and this complaint is a major step to improve how the San Francisco sewer system is managed,” said EPA Pacific Southwest Regional Administrator Martha Guzman. “EPA and our partners are committed to ensuring San Francisco comes into compliance with the Clean Water Act to protect clean water and local communities.”
The United States and the San Francisco Water Board request that the Court order the City of San Francisco to cease further violations of the Clean Water Act and its permits and complete all actions necessary to ensure that the City complies in the future. On average each year since 2016, San Francisco has discharged more than 1.8 billion gallons of untreated sewage from its combined sewer systems into creeks, San Francisco Bay, and the Pacific Ocean, including areas popular for wading, swimming, surfing, kayaking and fishing. San Francisco is served by two combined sewer systems that collect domestic sewage, industrial and commercial wastewater, and stormwater in the same pipes. During heavy rains, when the sewage treatment plants are at maximum capacity, combined sewage is discharged from near-shore outfalls to creeks, the San Francisco Bay, and the Pacific Ocean without receiving disinfection treatment.
San Francisco’s failure to take steps to minimize these discharges or provide disinfection treatment interferes with the state’s designated uses for these water bodies, which include water contact recreation and protection of aquatic life. Untreated sewage contains pathogens such as E. coli, which can cause severe illness if ingested. Children, the elderly, people with weakened immune systems and pregnant women have a higher risk for adverse consequences from such illness than the general population.
In addition, San Francisco’s combined sewer systems are in a state of disrepair, and the City’s failure to properly operate and maintain them has led to additional combined sewage discharges that has put members of the public at risk for unknowingly coming into contact with untreated sewage. San Francisco has also consistently failed to properly notify the public about the presence of untreated sewage at popular water recreation locations, overflows from manholes onto sidewalks and streets and the risks of coming into contact with untreated sewage.
EPA has brought enforcement actions to require municipalities across the country to update their sewer systems and address similar Clean Water Act violations. Nationally, EPA has been working with states, municipalities, and trade organizations to develop tools to help communities work towards compliance with Clean Water Act requirements, including meeting applicable water quality standards.
The State Water Board and nine regional boards administer and enforce the Clean Water Act in California, improving water quality for communities and the environment while working with wastewater systems to help bring them into compliance. In 2023, the Water Boards took 260 wastewater enforcement actions under the Clean Water Act, with over six million dollars in assessed penalties.
San Francisco is one of approximately 750 communities in the country with combined sewer systems but is only one of two such systems in California. San Francisco began planning to address its combined sewer overflows in the 1970s and completed construction of planned controls over 25 years ago. Since completion of those controls, no significant upgrades or updates have been made to the system to reduce combined sewer overflows and currently, the controls are insufficient to meet the requirements in San Francisco’s Clean Water Act permits.
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