USA Regulatory News

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.

On October 9, 2024, the U.S. Environmental Protection Agency (EPA) issued its fifth Test Order under the Toxic Substances Control Act (TSCA) as part of its National PFAS Testing Strategy. This is the ...

On October 9, 2024, the U.S. Environmental Protection Agency (EPA) issued its fifth Test Order under the Toxic Substances Control Act (TSCA) as part of its National PFAS Testing Strategy. This is the latest step in EPA’s PFAS Strategic Roadmap to address contamination from "forever chemicals". The order requires several companies to test 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl prop-2-enoate (CAS 17527-29-6), also known as 6:2 fluorotelomer acrylate or 6:2 FTAc. 6:2 FTAc, a chemical used in plastics, textiles, and other materials, with annual production ranging from 1 million to 20 million pounds.

Risk and Hazard Assessment Outcome

Summaries of studies on rodent exposure to 6:2 fluorotelomer acrylate (6:2 FTAc) indicate that it may alter blood cell counts, increase liver and kidney size, and affect animal behaviour. The chemical's structure raises concerns about its potential carcinogenic effects. PFAS, including 6:2 FTAc, can accumulate in the body and the environment, with even minimal exposure posing long-term health risks, including cancer, liver and heart damage, and developmental harm to infants and children.

EPA has determined that 6:2 FTAc may present an unreasonable risk to human health and the environment due to these hazards. The data gathered under this order will enhance the Agency’s understanding of the health effects of 6:2 FTAc and provide insights into the potential impacts of over a hundred structurally similar PFAS compounds. This information will also contribute to EPA's overall knowledge of this category of substances.

Recommendations in the Order

Companies affected by the Test Order may either perform the specified tests on physical-chemical properties and health effects from exposure or submit existing information that meets the order's requirements. EPA encourages collaborative testing to minimize duplication and will consider combining tests to address multiple endpoints, thus reducing time, costs, and reliance on animal subjects.

The order utilizes a tiered testing process, as mandated by TSCA. All but one of the first-tier test results must be submitted to EPA within one year of the order's effective date. Hydrolysis, as affected by pH, is a first-tier test that must be completed within 390 days. The outcomes of these initial tests will determine any additional testing requirements and methodologies.

Testing Required by the Order:

1. Physical-Chemical Properties

Tier 1.1- required testing

a. Melting point/ melting range (OECD 102 (1995))

b. Boiling point (OECD 103 (1995))

c. Vapor pressure (OECD 104 (2006)) as applicable to liquids

d. Water solubility (OECD 105 (1995))

e. Hydrolysis as a function of pH (OECD 111 (2004))

f. n-octanol/water Partition Coefficient HPLC Method, or KOW (OECD 117 (2022))

2. Environmental Fate and Behavior

Tier 1.1 – required testing

1. Estimation of the Adsorption Coefficient, or KOC, on Soil and Sewage Sludge using High

Performance Liquid Chromatography (HPLC) (OECD 121 (2001))

Tier 2.1 – required testing

1. Bioaccumulation in Fish: Aqueous and Dietary Exposure (OECD 305 (2012))

3. Health Effects: Dermal Route

Tier 1.2 – required testing dependent on results of Tier 1.1 Hydrolysis as a Function of pH test

a. Skin Absorption: In Vitro Method (OECD 428 (2004))

4. Health Effects: Mechanistic for Genotoxicity

Tier 1.2 – required testing dependent on results of Tier 1.1 Hydrolysis as a Function of pH; specific protocol may depend on results of the Tier 1.1 Vapor Pressure test

a. Bacterial Reverse Mutation Test (OECD 471 (2020))

b. One of the following:

i. In Vitro Mammalian Chromosomal Aberration Test (OECD 473 (2016))

ii. In Vitro Mammalian Cell Micronucleus Test (OECD 487 (2023))

iii. In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (OECD 490 (2016))

5. Health Effects: Oral and Inhalation Routes

Tier 2.1 – required testing

a. Toxicokinetics, oral exposure (OECD 417 (2010))

Tier 2.2 – required testing in a single rodent species dependent on TK oral study results

b. Toxicokinetics, inhalation exposure (OECD 417 (2010))

c. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity

Screening Test (OECD 422 (2016))

The order and any data submitted in response will be publicly accessible on EPA’s website and in the relevant docket on Regulations.gov, with confidentiality provisions in accordance with TSCA Section 14.

On September 30, 2024, the U.S. Environmental Protection Agency (EPA) updated the Safer Chemical Ingredients List (SCIL) to promote transparency and support safer product innovation. The update includ...

On September 30, 2024, the U.S. Environmental Protection Agency (EPA) updated the Safer Chemical Ingredients List (SCIL) to promote transparency and support safer product innovation. The update includes the addition of 27 chemicals, updates to 23 listings, and a planned removal of one chemical after 12 months. Fragrances have also been moved to a more comprehensive list to help manufacturers find approved options for Safer Choice-certified products.

Introduction

The Safer Chemical Ingredients List (SCIL) is a comprehensive compilation of chemicals evaluated by EPA’s Safer Choice program that meet stringent safety criteria. With this latest update, the SCIL now includes 957 chemicals recognized as some of the safest for their intended uses. This list helps manufacturers identify suitable chemicals for products aiming for Safer Choice certification.

Additions to the SCIL

EPA has added 27 new chemicals to the SCIL, increasing the total for 2024 to 29. These additions include colorants, preservatives, processing aids, additives, polymers, solvents, and surfactants, providing manufacturers with more options for creating high-performance products using safer chemicals.

Moving Fragrances from the SCIL

Fragrances may be used in Safer Choice-certified products if they meet the Safer Choice Criteria for Fragrances. EPA is moving fragrances previously listed on the Safer Choice Ingredients List (SCIL) to the Safer Choice Fragrances Palette, which will now serve as the comprehensive source of approved fragrances. The criteria remain unchanged, allowing any fragrance that meets these standards in Safer Choice-certified products. Additionally, for those seeking fragrance-free options, EPA will maintain the Fragrance-Free Safer Choice label on qualifying products, with approximately 300 fragrance-free products currently certified.

Updating SCIL Listings

EPA is updating the status of 23 chemicals on the Safer Chemical Ingredient List (SCIL), using color codes to indicate confidence levels in their safety. As part of this routine maintenance, 20 solvents previously classified as "full green circles" or "yellow triangles" are now reclassified as "half-green circles," indicating low concern but needing more data to bolster their safer status. Additionally, propyl acetate is now designated as a "yellow triangle," meaning it meets Safer Choice Criteria but still has some health and environmental concerns.

EPA has also reclassified methyl ethyl ketone as a specialized industrial chemical, consistent with other chemicals in its hazard profile. Furthermore, ethyl lactate has been changed to a "grey square" status and may be removed from the list in one year if health concerns are not addressed, as no Safer Choice-certified products currently contain this chemical.

EPA is dedicated to regularly updating the SCIL with safer chemical options. They encourage manufacturers to submit their safer chemicals for review and potential inclusion on the SCIL, which will be updated at least annually to reflect advances in safer chemistry.

On October 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories, covering over 100 chemicals, to the ...

On October 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories, covering over 100 chemicals, to the Toxics Release Inventory (TRI). The proposal would designate them as chemicals of special concern, requiring more robust reporting, even for small concentrations. This move aligns with the Biden-Harris Administration's and EPA's PFAS Strategic Roadmap to address the health and environmental risks of PFAS, boost pollution prevention, and enhance public access to data on environmental releases of these persistent "forever chemicals."

The proposal aims to enhance public and regulatory access to data on toxic chemicals, including those linked to cancer, allowing communities to identify pollution sources and helping facilities reduce or eliminate emissions.

Proposed Rule

1. EPA is proposing to add certain PFAS to the Toxic Release Inventory (TRI) due to their links to health risks such as cancer, liver and kidney damage, and reproductive harm.
2. EPA is proposing a 100-pound reporting threshold for the manufacture, processing, and use of PFAS, aligning with existing TRI reporting requirements established by the National Defense Authorization Act for Fiscal Year 2020. If approved, all PFAS within a category will contribute to the reporting threshold, preventing facilities from avoiding disclosure by claiming that individual PFAS do not meet the threshold. Additionally, EPA plans to reclassify certain PFAS previously added to the TRI individually, consolidating them into 15 broader categories.
3. EPA is also seeking to clarify how PFAS are automatically added to the TRI under the NDAA.

Toxics Release Inventory

The Toxics Release Inventory (TRI) was established to monitor toxic chemical waste management and promote pollution prevention to protect public health. Regulated facilities must report annually to EPA on the quantities of toxic chemicals released into the environment, as well as those managed through recycling, energy recovery, and treatment. Additionally, facilities must disclose practices aimed at minimizing waste generation. EPA makes this data publicly available to aid in decision-making and to promote pollution prevention initiatives.

Rule History

On December 20, 2019, the National Defense Authorization Act (NDAA) was signed into law, adding certain PFAS to the TRI under the Emergency Planning and Community Right-to-Know Act. The NDAA establishes a framework for the annual addition of PFAS to the TRI and requires EPA to consider additional substances for inclusion. The Agency is now proposing to add identified PFAS in accordance with this mandate.

The NDAA allows for the automatic addition of PFAS to the TRI when EPA finalizes a toxicity value. To clarify this process, EPA is proposing a list of toxicity values that would trigger the inclusion of associated PFAS.

Public comments on the proposed rule will be accepted for 60 days following its publication in the Federal Register via docket EPA-HQ-TRI-2023-0538 at Regulations.gov.

On September 23, 2024, the U.S. Environmental Protection Agency (EPA) finalized its risk evaluation of the flame retardant and plasticizer tris(2-chloroethyl) phosphate (TCEP) under the Toxic Substanc...

On September 23, 2024, the U.S. Environmental Protection Agency (EPA) finalized its risk evaluation of the flame retardant and plasticizer tris(2-chloroethyl) phosphate (TCEP) under the Toxic Substances Control Act (TSCA), concluding that it poses an unreasonable risk to human health and the environment. This is the first completed evaluation of the 20 High-Priority Substances identified in 2019. EPA's assessment considered TCEP exposure in vulnerable populations, including workers, pregnant women, infants, children, fenceline communities, and those with fish-heavy diets, including Tribes.

Uses and Risks Associated with TCEP

TCEP (CASRN 115-96-8) is a colorless liquid commonly used as a flame retardant and plasticizer in aerospace products, paints, and coatings. While domestic production of TCEP has dropped by 99% since 2014, it is still used in some structural and automotive applications in the U.S. and as a flame retardant and plasticizer for specific aerospace applications.

TCEP can leach into the environment, contaminating water, soil, and air. EPA has identified it as posing unreasonable risks, including kidney cancer, nervous system damage, and fertility issues, particularly to workers and consumers.

Risk Evaluation Findings

EPA has identified seven of 21 uses of the chemical TCEP as posing significant risks to workers:

• Manufacturing imports
• Paint and coating manufacturing
• Polymers used in aerospace equipment and products
• Aerospace equipment and products and automotive articles and replacement parts containing TCEP 
• Paints and coatings for industrial use 
• Paints and coatings for commercial use and 
• Laboratory chemicals

EPA has identified unreasonable risks from both inhalation and skin contact when workers handle or apply liquid formulations containing TCEP, especially in spray paints and aerospace-related resins. Consumers face risks from TCEP in fabric, foam, and wood products, particularly from inhalation or ingestion of dust. Infants and children may be vulnerable if they put such products in their mouths. EPA also highlighted concerns for people who consume large amounts of fish contaminated with TCEP, especially subsistence fishers and Tribes. Additionally, TCEP poses environmental risks, particularly to fish in contaminated water, though no significant risks were found for terrestrial animals.

Next Steps

EPA is now advancing risk management efforts to address the unreasonable risks associated with TCEP. A proposed rule will be issued under TSCA Section 6 to safeguard both humans and the environment from the identified hazards.