USA Regulatory News

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 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.

On September 10, 2024, the Food and Drug Administration (FDA) acknowledged concerns regarding the safety of tampons after a 2024 study found metals in tampons during laboratory testing. To be legally ...

On September 10, 2024, the Food and Drug Administration (FDA) acknowledged concerns regarding the safety of tampons after a 2024 study found metals in tampons during laboratory testing. To be legally sold in the U.S., tampons must adhere to FDA standards for safety and effectiveness. Manufacturers are required to test the product and its materials at various stages of production. Additionally, biocompatibility testing, conducted by the manufacturer and reviewed by the FDA, is a crucial part of the safety evaluation before a product can be approved for market use.

Study:

Researchers at the University of California, Berkeley, have identified several toxic metals in tampons from 14 major brands across 30 different product lines. The study detected varying levels of arsenic, barium, calcium, cadmium, cobalt, chromium, copper, iron, manganese, mercury, nickel, lead, selenium, strontium, vanadium, and zinc. However, the research did not investigate whether these metals are released during tampon use, absorbed into the vaginal lining, or enter the bloodstream.

Notably, the study found lead and other toxic metals in some products, which is concerning because lead has no known safe exposure level. Further research is needed to confirm these findings and explore if these metals can leach out and affect systemic health.

Action by FDA:

All tampons currently approved by the FDA have been assessed according to the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and have been found to meet FDA premarket requirements.

The Biocompatibility and Toxicology Program at the FDA’s Center for Devices and Radiological Health (CDRH) ensures that medical devices are safe and effective through regulatory science research.

The FDA has launched an independent literature review and an internal laboratory study to assess metals in tampons. The laboratory study will simulate typical use conditions to gauge metal release and help the FDA evaluate potential risks. Findings will be shared publicly after peer review. The FDA will maintain oversight of tampons as part of its comprehensive total product lifecycle approach to medical devices.

On September 6, 2024, the U.S. Environmental Protection Agency (EPA) issued an Enforcement Alert under the American Innovation and Manufacturing Act (AIM Act), aimed at phasing down the production and...

On September 6, 2024, the U.S. Environmental Protection Agency (EPA) issued an Enforcement Alert under the American Innovation and Manufacturing Act (AIM Act), aimed at phasing down the production and consumption of hydrofluorocarbon (HFC). The Alert highlights common compliance issues with bulk HFC imports and recent enforcement actions and urges companies to follow regulations to avoid potential penalties and support efforts to address the climate crisis.

AIM Act:

The AIM Act, enacted on December 27, 2020, mandates an 85% phasedown of hydrofluorocarbons (HFCs) from historical baseline levels by 2036. EPA is authorized to limit production, consumption, and imports of HFCs; facilitate the transition to next-generation technologies; and minimize releases from equipment that uses HFCs. To implement this, EPA will issue transferable HFC production and import allowances (which producers and importers of HFCs must hold in quantities equal to the amount of HFCs they produce or import). The rule sets baselines, establishes allowance allocations, and outlines recordkeeping and compliance measures. Between 2022 and 2050, this phasedown is expected to prevent the emission of 4,560 million metric tons of HFCs in the U.S. Violations of the requirements established in the AIM Act may be subject to administrative, civil, or criminal enforcement actions. 

Hydrofluorocarbons:

Commonly used in air conditioning, refrigeration, fire suppression, solvents, foam blowing agents, and aerosols, HFCs are potent greenhouse gases with global warming potentials (GWPs) hundreds to thousands of times higher than CO2. Their global use has surged due to the phaseout of ozone-depleting substances and increasing demand for cooling. However, lower GWP alternatives, including non-fluorinated options and HFC blends, are available or under development. EPA’s efforts under the AIM Act contribute to a global HFC phasedown, which could reduce global warming by up to 0.5°C when fully implemented.

Updates:

In fiscal year 2024, EPA has completed nine civil settlements addressing unlawful imports of hydrofluorocarbons (HFCs), including recent actions against five companies. These companies imported HFCs without proper allowances, in violation of the AIM Act. The cases prevented emissions equivalent to more than 24,000 metric tons of CO2, comparable to the annual electricity use of 14,000 homes. The companies will pay a total of $115,551 in penalties. Additionally, criminal enforcement actions have been initiated this fiscal year.

If you suspect illegal HFC imports, please report them to the EPA through its Report Environmental Violations webpage.