USA Regulatory News

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.

Safer Choice Program The Safer Choice Program promotes the use of chemicals that meet U.S. Environmental Protection Agency’s (EPA) strict standards for health and environmental safety, offering c...

Safer Choice Program

The Safer Choice Program promotes the use of chemicals that meet U.S. Environmental Protection Agency’s (EPA) strict standards for health and environmental safety, offering companies a way to stand out with the Safer Choice label. With thousands of certified products, this label helps consumers easily identify safer products without compromising on performance.

Updates on the Program

On September 18, EPA introduced a new Outdoor Use Safer Choice label, expanding its existing Safer Choice program. The label identifies products such as pet care items, fire defense products, and cleaners for cars, boats, and grills that meet EPA's stricter environmental criteria. EPA scientists assess every ingredient irrespective of its concentration to ensure that products are safe for public health and the environment.

The Safer Choice program mandates that products typically used outdoors must contain ingredients that break down quickly and have low aquatic toxicity. Even indoor-use products, such as all-purpose cleaners, can meet these stricter environmental standards if they comply with the additional criteria.

More than 50 products have already met the new outdoor-use standards, with more expected to carry the label by next year. Consumers can find Safer Choice-certified products for outdoor use on the Safer Choice search page by selecting the “Products with outdoor uses” box.

Ecolabels and Sustainable Products

On September 10, EPA proposed an update to its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. This guidance helps federal buyers choose sustainable, climate-friendly products with safer chemical ingredients.

Proposed Rule

The update proposes adding 14 standards and ecolabels in three new categories -healthcare, laboratories, and clothing - as well as expanding the food service ware category. The Recommendations aim to promote energy and water conservation, increase recycled content, and reduce the use of PFAS and single-use plastics.

If approved, the proposed updates to EPA's Recommendations would offer new guidance to federal purchasers and buyers on the procurement of sustainable products and service in four categories, divided into nine sub-categories. The changes would expand the current food service ware sub-category, which now includes only one recommended ecolabel for compostable products. The updated recommendations would add three additional standards and ecolabels for reusable, certified compostable, and certified recyclable food service ware.

In April 2022, EPA introduced stricter criteria for including standards and ecolabels in its Recommendations, requiring third-party verification and an updated directory of qualifying products. The Agency now plans to remove seven standards or ecolabels that fail to meet these requirements, are discontinued, or are no longer needed.

The public can comment on these proposed changes within 30 days of publication via docket EPA-HQ-OPPT-2022-0835 at Regulations.gov.

On September 3, 2024, the White House Office of Science and Technology Policy (OSTP) unveiled a new federal research strategy to address per- and polyfluoroalkyl substances (PFAS), commonly referred t...

On September 3, 2024, the White House Office of Science and Technology Policy (OSTP) unveiled a new federal research strategy to address per- and polyfluoroalkyl substances (PFAS), commonly referred to as "forever chemicals." This initiative builds on the Biden-Harris Administration’s ongoing efforts to protect communities from PFAS contamination, while supporting the Biden Cancer Moonshot’s mission to reduce Americans' exposure to cancer-causing chemicals.

Per- and Polyfluoroalkyl Substances

Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been used in consumer products since the 1950s. Found in items such as non-stick cookware, stain-resistant fabrics, and firefighting foam, PFAS are highly durable due to their strong carbon-fluorine bonds, making them resistant to environmental degradation.

Background:

In recent years, the Biden-Harris Administration has intensified efforts to prevent PFAS releases and expand cleanup initiatives. In March 2023, the PFAS Strategy Team (PFAS ST) released a scientific report identifying research gaps and opportunities that informed the development of a new strategic plan. The report highlighted key areas for future research, including PFAS sources and exposure pathways, toxicity, removal and destruction methods, and safer alternatives to these chemicals.

Strategy:

Building on the 2023 PFAS Report, the PFAS Strategy Team has outlined four key goals for federal research and development on PFAS. These include:

1. Improving scientific data on exposure pathways.
2. Enhancing communication with affected communities and agencies.
3. Identifying technologies to address contamination.
4. Providing information to guide procurement decisions on PFAS-containing products and alternatives to minimize health and environmental risks.

The PFAS ST has identified five key research and development strategies to address existing knowledge gaps on PFAS. These strategies focus on:

1. Understanding PFAS exposure pathways to individuals and communities.
2. Addressing current PFAS measurement challenges through the development of standards, advanced sampling and analytical methods.
3. Understanding the toxicological mechanisms, human and environmental health effects, and risks of PFAS exposure.
4. Developing, evaluating, and demonstrating technologies for the removal, destruction, and disposal of PFAS.
5. Identifying PFAS alternatives and evaluate their human health and environmental effects.

The team also aims to create a comprehensive database of alternative materials and products currently available in the market. This database will include relevant chemical and toxicological data, manufacturers’ production capacities, and performance comparisons between PFAS-containing products and their alternatives.

The successful implementation of this plan will enhance scientific progress and address regulatory, research, and mitigation gaps related to PFAS, while also addressing issues of disproportionate exposure, contamination, and toxicity.

On September 5, 2024, the U.S. Environmental Protection Agency (EPA) issued a direct final rule delaying the start of the reporting period for the October 2023 PFAS reporting rule under the Toxic Subs...

On September 5, 2024, the U.S. Environmental Protection Agency (EPA) issued a direct final rule delaying the start of the reporting period for the October 2023 PFAS reporting rule under the Toxic Substances Control Act (TSCA). Originally set to begin on November 12, 2024, the reporting period is now postponed until July 2025 due to resource constraints.

Background:

Under section 8(a)(7) of the Toxic Substances Control Act (TSCA), a reporting rule mandated by the FY2020 National Defense Authorization Act requires all manufacturers, including importers, of per- and polyfluoroalkyl substances (PFAS) and products containing PFAS since 2011 to report detailed information to EPA. This includes data on chemical identity, uses, production and processing volumes, byproducts, environmental and health effects, worker exposure, and disposal practices.

The 2023 reporting rule would have provided EPA, its partners, and the public with the largest dataset on PFAS manufactured and used in the U.S., a critical step in the agency’s PFAS Strategic Roadmap. This data will help EPA and state, local, and Tribal governments understand the uses and quantities of PFAS and support efforts to research, monitor, and regulate these chemicals. However, due to long-standing resource constraints, including a $5 million budget cut in FY 2024, EPA's program has delayed implementation of the rule and reduced its IT operating budget, impacting key initiatives and contractual support for data collection systems.

Due to delays, the agency's software application for collecting PFAS data will not be ready by the originally scheduled November 2024 opening date, making it impossible for submitters to begin submitting data by that date.

Proposed rule:

The proposed rule aims to adjust the data submission timeline by opening the submission period on July 11, 2025, when the Agency anticipates its software reporting application will be fully operational. Most reporters will be required to complete their submissions by January 11, 2026. However, small businesses that report only on the import of articles containing PFAS will have until July 11, 2026, to submit their reports.

To assist those affected by this rule, EPA has made guidance materials available on its website. EPA plans to launch a new guidance webpage on the TSCA GuideME database in the coming months, which will feature additional resources such as video tutorials, fact sheets, and other electronic reporting tools to help with compliance. EPA is also accepting public comments on both the direct final rule and the proposed rules until October 7, 2024, during a 30-day comment period.