EPA Reforms New Chemical Review Process to Better Protect Public Health

The EPA finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA) to ensure that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative and toxic (PBT) chemicals with potential for human exposure are always subject to the full, robust safety review process prior to manufacture. Under TSCA, EPA plays an important role by reviewing the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment.

 

This final rule ensures that new PFAS are always subject to the full, robust safety review process prior to manufacture by eliminating their eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). Existing regulations allow EPA to grant safety review exemptions for the manufacturing of chemicals with low production quantities, environmental releases or human exposures. These exemptions allow the chemicals (which historically have included some PFAS) to undergo a shorter review instead of the full, robust review prior to manufacture.

 

Under TSCA, manufacturers (including importers) and processors must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Prior to the 2016 amendments, EPA only made formal safety determinations on approximately 20% of new chemical submissions. Now, the new law requires EPA to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the market.

 

This rule amends the regulations by specifying that EPA must make one of the five specified statutory determinations on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing the new chemical substance. The rule also updates the regulations to list the actions required in association with each of those determinations.

 

These amendments align the regulations with TSCA section 5 requirements to reflect the full extent of new chemicals review, providing consistency and transparency in new chemicals review processes.

 

The final rule also makes several other changes to add efficiencies to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete. EPA is changing its longstanding practice of accepting amended notices that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period. Instead, EPA will now exercise its authority under the regulations to declare the original submission incomplete and restart the review period when the completed submission is received. This will save time and resources that could instead be spent reviewing complete submissions more quickly.

 

These reforms will also help industry to provide complete submissions for review through a new set of information “pick-lists” that will be incorporated into the application form located in EPA’s Central Data Exchange in a phased approach.

 

This rule will go into effect 30 days after publication in the Federal Register.

 

New guidance from OSHA includes recommendations that employers can use to address arc flash hazards within their safety and health programs. Arc flashes, also known as electric arcs, are electrical explosions that produce temperatures greater than 35,000 F—“nearly four times the temperature of the surface of the sun,” the guidance notes—along with shrapnel, concussive forces, and deafening sounds. Items within a three-foot radius of an arc flash are likely to burn, melt, or vaporize, though most injuries from arc flashes result from the ignition of flammable clothing. The frequency of arc flash incidents is uncertain, but the National Fire Protection Association has estimated that up to ten arc flash explosions occur in the United States each day.

 

OSHA’s guidance identifies several hazards that may lead to arc flashes, including faulty electrical equipment, operating equipment beyond its rated capacity, lack of proper warning systems, and inadequate personal protective equipment. Employers are required to estimate the incident heat energy of electrical conductors or equipment in order to determine the arc flash boundary, which is the distance at which a worker without appropriate PPE could receive second-degree burns. Organizations have developed different methods for calculating arc flash incident energy levels, but some of them may not be applicable in all situations. The guidance recommends that employers use multiple calculation methods and implement the most conservative.

 

The guidance emphasizes that the arc flash boundary is separate from the restricted approach and limited approach boundaries defined in NFPA 70E, Standard for Electrical Safety in the Workplace. The restricted and limited approach boundaries are intended to protect against electric shock, not arc flash. The arc flash boundary can lie within either the restricted or limited approach boundaries or extend beyond them.

 

“Whenever there is a likelihood of arc flash incident, employers should determine and use both the arc flash boundary and the limited/restricted approach boundaries to ensure worker safety,” the guidance reads.

 

OSHA’s guidance includes a discussion of the hierarchy of controls as it pertains to arc flash hazards as well as a table that identifies specific types of arc-rated PPE. For more information, download the guidance as a PDF.

 

 

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Two Kansas plastic packaging companies, Packaging Products Corporation, LLC in Mission and PPC Flexible, LLC in Kansas City, have agreed to collectively pay a civil penalty of $182,879 and to spend nearly $710,000 in upgrades to resolve violations of the federal Resource Conservation and Recovery Act (RCRA).

 

Both companies are subsidiaries of PPC Flex and manufacture food-grade packaging, a process which involves generating hazardous ink and solvent waste. According to the EPA, the companies violated multiple federal regulations intended to protect workers and the public from exposure to the hazardous waste.

 

EPA inspected the Packaging Products and PPC Flexible facilities in 2022 and 2023 and determined the companies violated federal law by:

 

“EPA is committed to leveling the playing field for companies that comply with federal law,” said EPA Region 7 Enforcement and Compliance Assurance Division Director David Cozad. “This settlement demonstrates EPA’s commitment to protect communities from releases of hazardous waste, especially those already burdened by historical pollution.”

 

In addition to paying the civil penalty, the settlement with EPA includes the implementation of a computerized upgrade to Environmental Management Systems designed to track compliance obligations with state and federal requirements, as well as the complete replacement of halogen and fluorescent lighting systems with energy-efficient and hazardous waste-free LED lighting, at 11 PPC Flex facilities nationwide.

 

EPA identified the community in Kansas City, Kansas, surrounding the PPC Flexible facility as a potentially sensitive area, because of exposures to particulate matter, air toxics cancer risk, toxic air releases, Superfund site proximity, hazardous waste proximity, and wastewater discharges. EPA is strengthening enforcement in overburdened communities to address disproportionately high and adverse human health or environmental effects of industrial operations on vulnerable populations.

 

According to EPA, Packaging Products, which no longer operates its Mission, Kansas, facility, and PPC Flexible qualified as “large quantity generators” of hazardous wastes. Exposure to these kinds of waste may lead to injury or death. Federal law requires facilities that generate hazardous wastes to identify the waste and implement safe generation, handling, transportation, and disposal practices.

 

For the eighth time since 2020, federal workplace safety inspectors have cited a Lake Zurich roofing contractor for exposing workers to falls from elevation, the leading cause of fatal and serious injuries among people employed in the construction industry.

 

Inspectors with OSHA observed employees of Fino Exterior, Inc. working atop residential structures without legally required fall protection equipment on four occasions in 2024, in Palatine on Feb. 6, Orland Park on June 12, Palos Heights on Aug. 16 and Shorewood on Oct. 16. Fino Exterior's troubling history of ignoring federal safety regulations continued as OSHA cited the company for 13 safety violations in three inspections in four months and proposed $262,631 in penalties.

 

"Fino Exterior's blatant disregard for its employees' safety is a callous invitation to tragedy," explained OSHA Chicago South Area Director James Martineck in Tinley Park, Illinois. "All too often, our inspectors find construction contractors violating regulations repeatedly in their misguided belief that their workers will not fall victim to serious injuries or worse."

 

In addition to a lack of fall protection, OSHA cited Fino Exterior for the following violations:

 

"A worker can lose their footing and fall off a roof in seconds," Martineck added. "Falls from elevation can cause life-altering and deadly injuries all of which can be prevented by using required protective equipment and training workers in its use. Employers who ignore their obligations are putting their workers' lives and well-being in serious risk."

 

The 2024 infractions continue a series of similar citations issued after six inspections since 2020 and two others issued under a previous operating name, Arellano Roofing Corp. Fino Exteriors Inc. is currently liable for $65,115 in unpaid OSHA penalties.

 

The Bureau of Labor Statistics reports 1,069 construction workers died on the job in 2022 and 395 of those deaths were fall-related. The Centers for Disease Control and Prevention report that falls caused about 20,000 worker injuries annually between 2013 and 2022.

 

 

Plaze Inc. of Pacific, Missouri, has agreed to pay a civil penalty of $205,791 to resolve violations of the federal Resource Conservation and Recovery Act (RCRA). The company operates 16 locations nationwide that formulate, blend, fill, and package over 2,500 aerosol and liquid products.

 

According to the EPA, Plaze violated multiple federal regulations intended to protect workers and the public from exposure to the hazardous waste it generated.

 

EPA inspected Plaze’s Pacific facility in November 2022 and determined the company violated federal law by:

 

In response to the inspection findings, Plaze Inc. agreed to take the necessary steps to return the Pacific facility to compliance.

 

According to EPA, Plaze qualifies as a “large quantity generator” of hazardous wastes, including wastes that are corrosive, toxic, and/or ignitable. Exposure to these kinds of waste may lead to injury or death. Federal law requires facilities that generate hazardous wastes to identify the waste and implement safe generation, handling, transportation, and disposal practices.

 

 

In November, EPA finalized the second part of its asbestos risk evaluation, supplementing the first part, which was completed in 2020. While the first part addressed only ongoing uses of chrysotile asbestos, the supplementary document evaluates risk to human health and the environment associated with legacy uses of asbestos, disposal of asbestos from legacy uses, uses of asbestos types other than chrysotile, and use of asbestos-containing talc.

 

The supplemental effort to part one of EPA’s risk evaluation for asbestos stems from a 2019 decision issued by the U.S. Court of Appeals for the Ninth Circuit, which determined in Safer Chemicals, Healthy Families v. EPA that the agency should not have excluded legacy uses of asbestos and associated disposals or other forms of asbestos from its risk evaluation. To comply with the court ruling, EPA produced the second part of its asbestos risk evaluation.

 

Legacy uses of asbestos are those with no ongoing manufacture, processing, or commercial distribution in the United States, but which may still cause asbestos exposures due to continued use or disposal. Potential legacy uses of asbestos include in floor and ceiling tiles, pipe wraps, insulation, and other building materials found in older homes. Non-chrysotile forms of asbestos include the five types of amphibole asbestos, which have needle-like rather than curly fibers. In the supplemental evaluation, EPA has determined that disturbing and handling asbestos in legacy uses, as well as asbestos as a chemical substance, poses “unreasonable risk to human health.”

 

Use of asbestos was formerly widespread in building materials and manufacturing processes. Chronic inhalation exposures to asbestos are associated with severe health effects such as mesothelioma and lung, ovarian, and laryngeal cancers. Chrysotile asbestos was the only form of asbestos known to be imported, processed, or distributed for use in the United States until March 2024, when EPA finalized a rule banning all ongoing uses of the substance. In the risk evaluation for chrysotile asbestos, the agency had determined that continued use of the substance presented unreasonable risk to human health, including to workers and occupational non-users.

 

According to the executive summary of part two (PDF), legacy uses of asbestos in building materials do not cause exposures if left undisturbed. However, exposures may occur when asbestos-containing materials are disturbed during construction, modification, or demolition by construction workers or do-it-yourself remodelers. Firefighters may also be exposed to asbestos fibers when they enter buildings containing asbestos during emergencies. In part two of the risk evaluation, EPA finds that legacy uses of asbestos in a range of construction and building materials and products, as well as in furnishing, cleaning, and treatment care products and disposal of these materials and products, “significantly contribute to the unreasonable risk of cancer and non-cancer health effects.”

 

Part two of the asbestos risk evaluation also determines that the risk of severe health effects is unacceptable for all asbestos types and uses, including those covered in part one. EPA explains in the Federal Register notice announcing the availability of part two that the agency considers a single risk determination appropriate “because there are benchmark exceedances for multiple conditions of use” of the chemical throughout its life cycle, from manufacturing to disposal. Part two of the asbestos risk evaluation further explains this decision.

 

EPA’s webpage on part two of the asbestos risk evaluation provides additional information, as well as links to download a PDF of the second part and many supplementary documents. Information on part one of the risk evaluation and associated risk management actions may also be found on the agency’s website.

 

 

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