USA Regulatory News

On December 18, 2024, the U.S. Environmental Protection Agency (EPA) announced its decision to formally classify five known or suspected carcinogens as High-Priority Substances (HPS) for risk evaluati...

On December 18, 2024, the U.S. Environmental Protection Agency (EPA) announced its decision to formally classify five known or suspected carcinogens as High-Priority Substances (HPS) for risk evaluation under the Toxic Substances Control Act (TSCA). Additionally, the Agency revealed the launch of a 9- to 12-month statutory process to prioritize another set of five chemicals under TSCA, aiming to determine whether they should also undergo risk evaluations.

EPA Begins Risk Evaluations for Five Chemicals

In July 2024, EPA proposed 5 chemicals for risk evaluation, releasing significantly more data earlier than previous efforts, providing the public better opportunities for input. This streamlined approach builds on improvements made over the past year, including advanced software for earlier data reviews, enhanced systematic review methods recommended by the Scientific Advisory Committee on Chemicals (SACC), and interactive tools to improve transparency.

EPA will now begin evaluating whether these substances pose unreasonable risks to health or the environment under their current uses. If risks are identified, the Agency will promptly initiate management measures to address them. The chemicals are:

• Vinyl chloride (CASRN 75-01-4), widely used in producing plastics such as PVC, plastic resins, and other materials for pipes, insulation, and consumer goods, poses significant health risks. Exposure can cause liver toxicity and is linked to cancer, as it is a known human carcinogen.
• Acetaldehyde (CASRN 75-07-0), widely used in manufacturing adhesives, petrochemicals, and intermediates for packaging and construction materials, poses health risks, including respiratory irritation. It is also a probable human carcinogen.
• Acrylonitrile (CASRN 107-13-1), widely used in producing plastics, paints, petrochemicals, etc., poses health risks, including respiratory irritation and is classified as a probable human carcinogen.
• Benzenamine (CASRN 62-53-3), widely used in manufacturing dyes, pigments, plastics, and chemicals, poses potential health risks including blood disorders, reproductive harm, and fetal development issues. It is also classified as a probable human carcinogen.
• 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4), widely used in manufacturing rubbers, plastics, and resins, is classified as a probable human carcinogen. Studies show it can damage genetic material in cells, posing significant health risks, especially to infants and children.

Prioritization Process Initiated for the Next Five Chemicals:

• Benzene (CASRN 71-43-2): Used in manufacturing adhesives, petrochemicals, plastics, and consumer products such as paints and fuels. Benzene is a known human carcinogen linked to leukemia and immune system impacts.
• Ethylbenzene (CASRN 100-41-4): Found in petroleum, paints, adhesives, and plastics. Exposure may harm the liver, kidneys, and hearing and is a probable carcinogen linked to lung and kidney tumors in animals.
• Naphthalene (CASRN 91-20-3): Used in paints, fuels, and metal products. It may cause red blood cell damage, liver and lung tissue harm, and is a probable carcinogen linked to lung and nasal tumors.
• Styrene (CASRN 100-42-5): Found in adhesives, plastics, toys, and construction materials. Styrene may lead to hearing loss, memory issues, miscarriages, and tissue damage. It is a probable carcinogen linked to lung tumors in animals.
• 4-tert-Octylphenol (CASRN 140-66-9): Used in plastics and automotive products. Exposure may cause kidney inflammation and reduced sperm count, potentially affecting fertility.

EPA has opened a 90-day public comment period, seeking information on the uses, hazards, exposures, and potential risks of the five chemicals under review. Comments are due by March 18, 2025.

On December 11, 2024, the U.S. Environmental Protection Agency (EPA) finalized a new rule to protect workers from carbon tetrachloride (CTC), a chemical linked to liver toxicity, cancer, brain tumors,...

On December 11, 2024, the U.S. Environmental Protection Agency (EPA) finalized a new rule to protect workers from carbon tetrachloride (CTC), a chemical linked to liver toxicity, cancer, brain tumors, and adrenal gland tumors. The rule mandates stringent worker safety programs and bans certain uses of CTC, in line with President Biden’s Cancer Moonshot initiative to combat cancer.

This is the fifth risk management rule under the bipartisan 2016 Toxic Substances Control Act (TSCA) amendments, marking a significant step forward for chemical safety after years of insufficient protection measures.

Carbon Tetrachloride

Carbon tetrachloride (CASRN: 56-23-5) is an industrial solvent used in the production of refrigerants, aerosol propellants, foam-blowing agents, pesticides, cleaning fluids, degreasers, fire extinguishers, and spot removers, etc. Its use in consumer products was banned in 1970 by the U.S. Consumer Product Safety Commission. Production of CTC for most domestic applications, excluding chemical manufacturing, was phased out in 1996 under the Montreal Protocol and the Clean Air Act.

CTC remains essential for the production of chemicals with low-global-warming-potential, supporting the goals of the American Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali Amendment to the Montreal Protocol.

Details on the Final Rule:

1. The final rule mandates protections for workers in most CTC uses being continued. Some uses that were initially prohibited will be permitted under the final rule, as public comments and evidence showed these uses were ongoing and that workplace safeguards could be applied.

2. Under the Workplace Chemical Protection Program, which includes inhalation limits and skin protection measures, the following uses of CTC will be allowed to continue:

• Incorporation into formulations, mixtures or reaction products in agricultural products manufacturing, vinyl chloride manufacturing (originally proposed to be prohibited), and other basic organic and inorganic chemical manufacturing.
• Repackaging for use as a laboratory chemical.
• Use as a processing aid to manufacture agricultural products.
• Use as a processing aid to manufacture vinyl chloride (originally proposed to be prohibited).
• Use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine. 
• Import, recycling, disposal and domestic manufacture of CTC.
• Processing as a reactant in the production of hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), hydrofluoroolefins (HFOs) and perchloroethylene (PCE).

3. In response to public feedback, companies now have 36 months to implement the Workplace Chemical Protection Program, allowing time to refine test methods for inhalation exposure limits.

4. Laboratory use of CTC will require workplace controls that are now better aligned with Occupational Safety and Health Administration (OSHA) standards.

5. The final rule also requires owners to ensure that engineering controls do not increase CTC emissions outside the facility, thereby protecting surrounding communities.

From December 9, 2024, the U.S. Environmental Protection Agency (EPA) will be implementing aban on trichloroethylene (TCE, CAS No: 79-01-6) and a phase-outof perchloroethylene (PCE, CAS No: 127-18...

From December 9, 2024, the U.S. Environmental Protection Agency (EPA) will be implementing aban on trichloroethylene (TCE, CAS No: 79-01-6) and a phase-outof perchloroethylene (PCE, CAS No: 127-18-4) under the bipartisan these long-awaited measures target two highly toxic chemicals linked to serious health risks, including cancer, and address years of inadequate protection. The rules aim to eliminate harmful exposures,promote safer alternatives, and protect public health, workers, and the environment.

Trichloroethylene (TCE): A Complete Ban on Use

TCE is a nonflammable chlorinated solvent that is a recognized carcinogen. It is known to cause liver cancer, kidney cancer, and non-Hodgkin’s lymphoma, as well as damage to the central nervous system, liver, kidneys, immune system, and reproductive organs. Even at low concentrations, TCE poses significant health risks.

Under the new rule, EPA will prohibit all consumer and most commercial uses of TCE within one year, as safer alternatives are available for most applications. Certain industrial uses of TCE will be phased out over a longer period of time with stringent worker protections, including a revised inhalation exposure limit designed to reduce long-term exposure by 97%. These uses, such as cleaning aircraft parts and manufacturing refrigerants, will eventually be banned, although exemptions allow for a gradual transition to avoid impacts on national security and critical infrastructure. Additionally, the use of TCE in the cleanup efforts at contaminated sites, such as Superfund locations, will be allowed for 50 years with necessary safeguards.

Perchloroethylene (PCE): Gradual Phase-Out and Strict Controls

PCE, another chlorinated solvent, is associated with liver, kidney, brain, and testicular cancer, as well as neurotoxicity and reproductive harm. PCE can degrade into TCE and may contain trace amounts of TCE impurities. While TCE is being banned entirely, some analogous uses of PCE will continue safely under strict workplace controls, including vapor degreasing and refrigerant production.

EPA has set a 10-year phase-out for PCE use in dry cleaning, with the transition beginning sooner for older machines. Many dry cleaners have already started this process. PCE use in consumer and commercial products will be largely phased out within three years. EPA’s rule also establishes strict controls for essential uses of PCE in critical sectors such as national security and aviation under the Workplace Chemical Protection Program.

These regulations prioritize safer, cost-effective alternatives to PCE and TCE, aligning with climate goalsand ensure the protection of workers, public health, and the environment under the Workplace Chemical Protection Program.

Protecting Health, Workers, and the Environment

These new regulations represent a major step forward in protecting public health, workers, and the environment while supporting climate goals. By prioritizing sustainable alternatives and ensuring workplace protections, EPA is addressing decades of advocacy and ensuring a safer future.

Earlier this year, Congress tasked EPA chemists with developing a process to prioritize per- and polyfluoroalkyl substances (PFAS) for research based on exposure risks, toxicity, and existing data. Un...

Earlier this year, Congress tasked EPA chemists with developing a process to prioritize per- and polyfluoroalkyl substances (PFAS) for research based on exposure risks, toxicity, and existing data. Under the Toxic Substances Control Act (TSCA), reporting, record-keeping, testing, and restrictions apply to chemicals of concern, including PFAS.

To address these requirements, EPA researchers created a category-based framework, grouping 128 PFAS into categories for streamlined data collection. This method, building on an earlier approach used for the National PFAS Testing Strategy, allows related PFAS to be assessed together rather than individually, with a model for classifying new substances.

The project results support EPA’s efforts to gather data on PFAS use via reporting rules and to issue TSCA test orders to generate toxicity data on specific chemicals within this large, under-researched group.

PFAS:

Per- and polyfluoroalkyl substances (PFAS) are synthetic chemicals, widely used since the 1940s, that persist in water, air, and soil worldwide. Due to their durability and extensive use, PFAS are commonly detected in the blood of humans and animals. These chemicals are prevalent in:

• Drinking Water and contaminated waste sites.
• Consumer Products such as non-stick cookware, stain-resistant fabrics, paints, and cosmetics.
• Food Packaging including microwave popcorn bags and grease-resistant wrappers.
• Industrial Settings such as chrome plating, electronics, and textile manufacturing.
• Firefighting Foam used at airports and training facilities.

The EPA's PFAS Strategic Roadmap has prioritized action since October 2021, allocating $10 billion under the Bipartisan Infrastructure Law to combat emerging contaminants such as PFAS.

While studies link certain PFAS to harmful health and environmental effects, the toxicity of most remains unexamined. Ongoing research is crucial to understanding and mitigating these "forever chemicals".

CHEMICAL CATEGORY-BASED APPROACH:

EPA researchers developed a detailed categorization approach for PFAS using the following steps:

1. Initial PFAS List: The researchers applied the PFAS definition from the Toxic Substances Control Act (TSCA) to the Distributed Structure-Searchable Toxicity (DSSTox) database, retrieving a list of 13,054 PFAS. They also included 2,484 predicted PFAS degradation products from the non-confidential TSCA inventory, expanding the list to 15,538 PFAS.
2. Category Assignment: Using OECD structure-based classifications, each PFAS was assigned to a primary category. The primary categories were further divided into secondary categories based on chain length thresholds (≥7 vs <7).
3. Subcategorization by Chemical Fingerprints: Secondary categories were subdivided using chemical fingerprints to balance structural categories and similarity within each category, as measured by the Jaccard index.
4. Identification of Representative PFAS: From the 128 terminal structural categories created, a subset of representative PFAS was selected for data collection. Factors such as the availability of toxicity data, environmental monitoring, and the potential to identify responsible manufacturers/importers guided this selection.
5. Future Refinements: The approach includes potential updates using mechanistic data and physicochemical properties, aiming to improve hazard assessments and QSAR development. This categorization method helps identify high-priority PFAS for further research and regulatory action.

This systematic approach helps to prioritize PFAS for further analysis and supports efforts in environmental monitoring and risk assessment.

On December 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed new Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemicals previously addres...

On December 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed new Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemicals previously addressed in premanufacture notices (PMNs). The SNURs mandate a 90-day advance notification to EPA before manufacturing or processing these substances for activities classified as significant new uses. This notification allows EPA to evaluate and determine the conditions for such uses. Manufacturing or processing for these purposes cannot begin until EPA completes its review and makes a formal determination. Comments must be received on or before January 2, 2025.

Proposed Rule Under TSCA Section 5:

EPA has introduced significant updates to its chemical regulations. Key highlights include:

1. Mandatory Determination Before Manufacturing
   • EPA must now issue a determination for each Pre-Manufacture Notice (PMN), Significant New Use Notice (SNUN), or Microbial Commercial Activity Notice (MCAN) before manufacturing or processing can begin.
   • The rule outlines five possible determinations and associated actions.
2. Enhanced Information Requirements
   • Amendments clarify the level of detail required in PMNs, SNUNs, and exemption notices for completeness.
3. Updated Review Procedures
   • New procedures address errors, incomplete submissions, and amendments made during the review period for PMNs and SNUNs.
4. Changes to LVE and LoREX Regulations
   • EPA approval is now mandatory before manufacturing under Low Volume Exemption (LVE) and Low Release and Exposure Exemption (LoREX) notices.
   • PFAS and certain PBTs are categorically ineligible for these exemptions.
   • EPA can notify exemption holders when their substance becomes subject to a Significant New Use Rule (SNUR), even if the chemical identity is confidential.
5. Simplified Suspension Requests
   • Submitters can request up to 30-day suspensions of TSCA Section 5 notices via oral or email requests.
6. Efficiency Improvements
   • Clarifications in chemical notice requirements and streamlined review procedures aim to improve the new chemicals review process.

These amendments, which incorporate feedback on the proposed rule published on May 26, 2023, will enhance transparency and efficiency in EPA’s regulatory processes.

EPA Proposes Updated Rules for 17 PFAS Under TSCA

On November 29, 2024, the U.S. Environmental Protection Agency (EPA) issued a supplemental notice of proposed rulemaking (SNPRM) to revise its December 2022 proposed significant new use rules (SNURs) for 17 per- and polyfluoroalkyl substances (PFAS). These PFAS, which are subject to premanufacture notices (PMNs) and TSCA Orders, require stricter oversight.

The proposed SNURs mandate that manufacturers or processors notify EPA at least 90 days before initiating any significant new use of these PFAS. Activities cannot proceed until EPA completes its review, issues a determination, and takes appropriate action.

Because these PFAS are not listed on the TSCA Inventory and lack ongoing uses, EPA is proposing to designate any manufacture or processing as a significant new use to enable risk evaluation.

Public comments on the proposal will be accepted until December 30, 2024.

The U.S. Environmental Protection Agency (EPA) has announced a proposal to revise the regulatory definition of volatile organic compounds (VOCs) under the Clean Air Act (CAA). The proposed change woul...

The U.S. Environmental Protection Agency (EPA) has announced a proposal to revise the regulatory definition of volatile organic compounds (VOCs) under the Clean Air Act (CAA). The proposed change would add (Z)-1-chloro-2,3,3,3-tetrafluoropropene, commonly referred to as HCFO-1224yd(Z) (CAS No. 111512-60-8), to the list of compounds excluded from the VOC classification. This decision is based on findings that the compound has a negligible impact on the formation of tropospheric ozone (O3), a key component of smog, and that it is unlikely to pose a risk to human health or the environment from its acceptable end uses.

Background on VOCs and Ozone Formation

Tropospheric ozone (O3), or smog, forms when VOCs and nitrogen oxides (NOx) react in sunlight. VOC emissions are regulated by EPA and state governments because they contribute significantly to the formation of ground-level ozone and cause severe respiratory problems. However, not all VOCs contribute equally to O3 formation because their reactivity varies. To prioritize efforts on compounds with significant impacts, EPA has excluded low-reactivity VOCs from its regulatory definition since 1971. This approach ensures targeted controls on substances that most influence ozone pollution.

Compounds can be excluded from the VOC list if scientific data and public petitions show that they have minimal impact on ozone formation. Since 1977, EPA has removed 63 compounds or classes from the list.

On July 29, 2020, AGC Chemicals Americas, Inc. submitted a petition to EPA requesting the exemption of HCFO-1224yd(Z) from the regulatory definition of VOCs. The petition argued that HCFO-1224yd(Z) exhibits low photochemical reactivity compared to ethane, meeting a key criterion for delisting under the VOC program.

Why HCFO-1224yd(Z) Meets Exemption Criteria

HCFO-1224yd(Z) is used in refrigeration systems, including turbo-type refrigerators, binary generators, and heat recovery heat pumps. As a refrigerant, it is not continuously emitted into the atmosphere in significant quantities. Refrigerators are initially charged with HCFO-1224yd(Z) and serviced with minimal loss of refrigerant to the atmosphere.

HCFO-1224yd(Z) exhibits a low maximum incremental reactivity (MIR) of 0.052±0.011 grams of ozone per gram of emissions, which is significantly lower than the MIR of ethane of 0.28. With a global warming potential (GWP) of just 0.88 over 100 years and a short atmospheric lifetime of about 20 days, it is far less harmful than other existing alternatives, which can have GWPs as high as 14,800. Its ozone depletion potential is close to zero (0.00023), and toxicity data suggest it is less harmful than other chemicals used for similar applications.

After a thorough review of the available scientific data, EPA has proposed excluding this compound from the list of VOCs, mainly due to its low photochemical reactivity.

Effects of the Proposal

This proposal would permit, but not mandate, states to remove regulatory controls on HCFO-1224yd(Z) from State Implementation Plans (SIP) aimed at meeting ground-level ozone standards.

EPA also aims to incentivize the use of negligibly reactive compounds by exempting them from VOC regulations. These compounds, which are considered less harmful, are listed in EPA’s regulations and excluded from the regulatory definition of VOC under 40 CFR 51.100(s).

On 22 November 2024, the U.S. Environmental Protection Agency (EPA) announced the release of interim guidance and additional resources to support implementation of the final rule for the Agricultural ...

On 22 November 2024, the U.S. Environmental Protection Agency (EPA) announced the release of interim guidance and additional resources to support implementation of the final rule for the Agricultural Worker Protection Standard (WPS) Application Exclusion Zone (AEZ).

The AEZ is a crucial safety measure that protects workers and bystanders from pesticide exposure during outdoor applications. This area surrounds the application equipment and moves with it during use. It can extend beyond the boundaries of an agricultural establishment to include areas like school grounds or residential neighbourhoods.

What is the AEZ Rule?

The Application Exclusion Zone (AEZ) is a safety feature in the Worker Protection Standard (WPS) that provides a buffer zone around pesticide application equipment to protect workers and bystanders from exposure. The AEZ can be extended beyond agricultural operations to include residential areas. Recent modifications to the AEZ rule enhance these protections by increasing the size and breadth of the zone and requiring applicators to stop activities if people are present in the AEZ, regardless of property borders. The updated rule aims to limit pesticide exposure, improve worker health, and protect communities.
In 2023, EPA proposed a regulation to reinstate and enhance the 2015 AEZ rules, which was finalised in October 2024.

Key Highlights of the Final Rule and Interim Guidance

• The final regulation strengthens protections for farmworkers, their families, and adjacent communities by expanding the AEZ to include workers outside the agricultural institution.

• The interim guidance explains how to comply with AEZs that extend off-property, how to calculate the necessary size depending on droplet size, and how to recognise exemptions for immediate family members.

• EPA is seeking input on the interim guidance and recommendations for additional resources.

Why the Final Rule is a Game-Changer?

• Reduced pesticide exposure to farmworkers and nearby communities.

• Improved employee health, resulting in reduced lost wages, medical expenses, and work/school absences.

• Improved understanding of AEZ standards for applicators and agricultural facilities.

EPA is dedicated to protecting the health and safety of agricultural workers, their families, and the general public from pesticide exposure.

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