USA Regulatory News

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

From December 9, 2024, the U.S. Environmental Protection Agency (EPA) will be implementing a ban on trichloroethylene (TCE, CAS No: 79-01-6) and a phase-out of 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.

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.

*Source

On November 13, 2024, the U.S. Environmental Protection Agency (EPA) released its final supplement to the risk evaluation and determination for the solvent 1,4-dioxane under the Toxic Substances Contr...

On November 13, 2024, the U.S. Environmental Protection Agency (EPA) released its final supplement to the risk evaluation and determination for the solvent 1,4-dioxane under the Toxic Substances Control Act (TSCA). The updated assessment no longer assumes that workers are consistently using proper personal protective equipment (PPE), addressing this in the risk management process. The evaluation also highlights gaps in the 2020 review, including the omission of general population exposure via drinking water and air, aggregate risks, and potential impacts on fenceline communities.

Uses, Exposures and Risks Associated with 1,4-Dioxane

1,4-Dioxane (CAS 123-91-1) is a solvent used in a variety of commercial and industrial applications. It is found in laboratories, in cleaning products such as dish soaps and laundry detergents, and in the production or processing of chemicals such as adhesives and sealants. It is often generated as a byproduct in manufacturing processes, leading to its presence as a contaminant in consumer products.

Products containing 1,4-dioxane can contaminate surface water when washed down the drain. Exposure to this chemical may occur through consumer products, workplace environments, or contaminated water and air, often due to industrial or commercial discharges.

EPA has determined that 1,4-dioxane poses an unreasonable risk to workers, nearby communities, and those who may be more sensitive to 1,4-dioxane due to factors such as age or pre-existing health conditions, citing its links to cancer, liver toxicity, and nasal tissue damage. The risks stem from inhalation and skin exposure during industrial use and from its presence as a byproduct in commercial products.

These groups could be exposed to 1,4-dioxane in drinking water, particularly in areas where water sources include smaller or slow-flowing streams that have been contaminated by industrial discharges. Additionally, runoff from households that use products containing 1,4-dioxane, such as dish soap, laundry detergent, and surface cleaners, could contribute to contamination.

1,4-Dioxane does not pose an unreasonable risk to the environment. 

Next Steps

EPA will propose a rule under TSCA Section 6 to protect public health from the identified risks of 1,4-dioxane. In line with TSCA Section 9(b), EPA is coordinating efforts across its agencies, including potential actions under the Safe Drinking Water Act (SDWA), to manage risks related to 1,4-dioxane contamination of drinking water. Both EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and Office of Water (OW) are working together to address these concerns.

Additional Information

Conditions of Use identified in the 2020 risk evaluation and 2024 supplement as contributing significantly to unreasonable risk include:

• Manufacture and Import
• Processing (e.g., repackaging, recycling, non-incorporative uses)
• Industrial/Commercial Use (e.g., intermediates, processing aids, metalworking fluids, adhesives, sealants, hydraulic fracturing)
• Consumer Use (e.g., dish soap, laundry detergent, paint)
• Disposal

Conditions of Use that do not significantly contribute to unreasonable risk are:

• Distribution in commerce
• Commercial use of automobile antifreeze, textile dyes, and spray polyurethane foam.

1,3-Butadiene Peer Review Will Follow Suit

On November 14, 2024, EPA announced a call for public comments on candidates to assist the Science Advisory Committee on Chemicals (SACC) in reviewing the draft Toxic Substances Control Act (TSCA) risk evaluation for 1,3-butadiene.

1,3-Butadiene (CAS 106-99-0) is a highly flammable, colorless gas with a gasoline-like odor. It is used in the manufacture of products such as rubber tires, plastics, adhesives, paints, and automotive care products.

The SACC is a scientific peer review body for EPA's Office of Chemical Safety and Pollution Prevention that provides independent advice and recommendations on risk assessments, methodologies, and pollution prevention strategies for chemicals regulated under TSCA.

The peer review will take place in early 2025 and will guide the final risk evaluation.

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) finalized revisions to existing regulations under the Toxic Substances Control Act (TSCA) for two persistent, bioaccumulative, and t...

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) finalized revisions to existing regulations under the Toxic Substances Control Act (TSCA) for two persistent, bioaccumulative, and toxic (PBT) chemicals—Decabromodiphenyl Ether (decaBDE) and Phenol, Isopropylated Phosphate (PIP (3:1)). This new rule aims to address implementation challenges and reduce potential human and environmental exposure to these hazardous substances.

Background

These revisions build on the final rules originally established in January 2021, which targeted five PBT chemicals identified for expedited action under TSCA Section 6(h). Following feedback from stakeholders and further analysis, EPA determined that additional measures were necessary for decaBDE and PIP (3:1). The revisions are designed to clarify compliance requirements, extend certain compliance deadlines, and provide more robust protections particularly in sectors such as agriculture, construction, life sciences, and mining.

Key Changes to the DecaBDE Regulations

DecaBDE (CAS 1163-19-5) is widely used as a flame retardant in a variety of industries, particularly in textiles, electronics, and automotive parts. The updated rule introduces several significant changes:

• Personal Protective Equipment (PPE) Requirements: Companies involved in manufacturing, processing, or distributing decaBDE must now ensure the use of PPE to limit worker exposure.
• Prohibition on Water Releases: The release of decaBDE into water during its manufacture and processing is now banned, reflecting heightened concerns over its environmental impact.
• Extended Compliance for Specific Uses: EPA has extended the compliance deadline for the use of decaBDE in wire and cable insulation for nuclear power facilities, recognizing the critical nature of this application. Similarly, companies must notify authorities when exporting decaBDE-containing materials for nuclear power uses.
• Threshold for Unintentional Presence: The rule allows a minimal presence of decaBDE (less than 0.1% by weight) in products, recognizing the challenges of completely eliminating trace amounts from complex supply chains.

Updates to PIP (3:1) Regulations

PIP (3:1) (CAS 68937-41-7) is commonly used as a flame retardant and plasticizer in hydraulic fluids, lubricants, and electronic components. The revised regulations include:

• Expanded PPE Requirements: Similar to decaBDE, EPA is mandating the use of PPE for handling PIP (3:1) during its domestic manufacturing and processing.
• Phase-Out of Certain Uses: The rule imposes a gradual phase-out of PIP (3:1) for specified applications while allowing exemptions for critical uses, such as wire harnesses and circuit boards, until suitable alternatives are found.
• Exemptions for Replacement Parts: The regulation introduces provisions for the continued use of PIP (3:1) in replacement parts for existing equipment, thereby minimizing disruptions in industries such as aerospace and automotive manufacturing.
• 10-year grace period to phase out the use of PIP (3:1) in parts for new equipment: The extended timeline applies to manufacturing and industrial machinery, commercial electronic equipment, refrigeration, water-heating systems, power-generating equipment, etc.

This allowance is intended to give industries sufficient time to transition to alternatives while maintaining compliance with the new safety standards.

The Agency highlighted the importance of reducing exposure to these toxic substances, which have been linked to adverse health effects, including developmental and neurological harm, as well as environmental damage.

Additional requirements 

The Final rule introduces new workplace safety measures to minimize dermal and respiratory exposure, although certain import and processing applications are exempt. Recordkeeping requirements have been extended from three to five years, with companies now required to have compliance records "readily available" for prompt review, eliminating the previous 30-day grace period.

For continued use of PIP (3:1), companies must update safety data sheets (SDSs) within three months and product labels within 18 months. The rule does not change existing requirements for the other three PBT chemicals regulated under the January 2021 rule: 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD), and pentachlorothiophenol (PCTP).

The rule is set to take effect 60 days after its publication in the Federal Register, with extended compliance dates for certain sectors.

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) released updated Toxics Release Inventory (TRI) data detailing toxic chemical waste management, including releases and pollution pre...

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) released updated Toxics Release Inventory (TRI) data detailing toxic chemical waste management, including releases and pollution prevention activities from 2023. The data covers over 20,000 industrial and federal facilities nationwide, providing essential insights for communities, agencies, and companies.

Established under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), TRI requires annual reporting from facilities in specific industry sectors that manufacture, import, process, or use a listed chemical in an amount that exceeds the given threshold for that chemical and activity (e.g., 25,000 lbs., 10,000 lbs. 100 lbs. etc.). TRI reports, known as "Form R" or "EPCRA 313," are due each year on July 1.

Updates from the 2023 Report:

The 2023 data report is submitted by facilities in sectors such as metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment. This updated dataset is based on preliminary 2023 data from July 2024 and incorporates revised and late submissions received by EPA as of October 23, 2024.

With EPA's enhanced TRI Toxics Tracker, communities can now map TRI-reporting facilities and explore data on chemical releases, waste management practices, and pollution prevention efforts. A comprehensive analysis of the 2023 data will be available in next year’s TRI National Analysis, which will assess trends, industry-specific waste management, and pollution reduction activities.

The current report suggests that zinc and lead compounds topped the list of chemical releases, with 415 million and 354 million pounds, respectively. Inorganic lead compounds, classified by EPA as probable carcinogens, pose cardiovascular, developmental, neurological, and reproductive risks. Other carcinogens released by facilities include arsenic (5.6 million pounds) and chromium compounds (4.7 million pounds).

The environmental and health impacts of mining these metals are significant. High doses of ingested zinc can cause gastrointestinal distress, and long-term exposure may lead to anemia and reduced levels of good cholesterol. Chronic manganese exposure harms multiple organs, potentially causing neurotoxic effects such as cognitive impairment, Parkinson's-like symptoms, and movement disorders such as dystonia.

The TRI data highlights the threat mining poses to drinking water sources, fish habitats, and wildlife. Toxic runoff from mine waste often leaches heavy metals such as lead and cadmium, along with arsenic, into ground and surface water. This report serves as a critical resource for communities near mines, especially Indigenous populations, who are disproportionately impacted by metal pollution.

PFAS-Related Updates: 

For the fourth consecutive year, Toxics Release Inventory (TRI) data includes reporting on per- and polyfluoroalkyl substances (PFAS), as mandated by the 2020 National Defense Authorization Act (NDAA). In 2023, facilities reported managing over 1.5 million pounds of PFAS-related waste, with 61 facilities submitting a total of 168 TRI forms covering 46 distinct PFAS compounds. In October 2023, EPA finalized a rule to enhance PFAS reporting by removing an exemption that previously allowed facilities to bypass reporting on PFAS when present in low concentrations. EPA expects expanded PFAS reporting in the 2024 TRI data.