USA Regulatory News

On July 31, 2024, the U.S. Environmental Protection Agency proposed a new rule under the Toxic Substances Control Act (TSCA) to restrict the use of the solvent 1-bromopropane (1-BP), which has been li...

On July 31, 2024, the U.S. Environmental Protection Agency proposed a new rule under the Toxic Substances Control Act (TSCA) to restrict the use of the solvent 1-bromopropane (1-BP), which has been linked to serious health risks, including cancer. This proposed rule, which would ban all but one consumer use and some workplace uses of 1-BP, is part of the Biden-Harris Administration’s ongoing efforts to protect public health. This is the seventh chemical to be addressed under TSCA Section 6(a).

About 1-Bromopropane

1-BP, a common solvent used in cleaning, adhesives, and construction materials, is also found in consumer products such as aerosol degreasers, spot cleaners, and insulation. Exposure to 1-BP can lead to severe health issues, including cancers of the skin, lungs, and intestines; damage to the liver, kidneys, and nervous system; and effects on the reproductive system that may reduce fertility.

Details of the Proposed Rule:

EPA is proposing to ban all consumer uses of 1-BP, with the exception of insulation, as it was found not to pose unreasonable risks to humans.  This ban on consumer uses would start within six months of the final rule and be fully enforced within 15 months.

Additionally, EPA plans to prohibit certain industrial and commercial uses of 1-BP, where safer alternatives are available. This industrial and commercial ban would also take effect six months after the final rule and be fully implemented within 18 months.

The industrial and commercial uses that would be prohibited include:

• Dry cleaning, spot cleaning and stain removers.
• Adhesives and sealants.
• Coin and scissor cleaners.
• Automotive care products used as engine degreasers, brake cleaners and refrigerant flushes.
• Anti-adhesive agents used for mold cleaning and release products.
• Functional fluids used as refrigerants or cutting oils.
• Arts, crafts and hobby materials.

Worker Protections

EPA is proposing enhanced worker protections for industrial and commercial uses of 1-BP that are not banned under the new rule, in support of President Biden’s Cancer Moonshot initiative. The proposed regulations would require non-federal workplaces to implement a Workplace Chemical Protection Program (including an exposure limit) within 12 months for ongoing uses of 1-BP deemed to pose an unreasonable health risk. Additionally, non-federal workplaces would be required to use chemical-resistant gloves for activities such as manufacturing, processing, and disposal. Federal agencies and contractors would be required to meet these standards within three years.

Public Participation

EPA invites public feedback on the proposed 1-BP rule, which will be open for comments for 45 days after its publication in the Federal Register. Members of the public may submit comments to docket EPA-HQ-OPPT-2020-0471 at the Regulations.gov page.

More details on the 1-BP proposal are available here.

On 29 July 2024, the California Department of Public Health (CDPH) published its updated reportable ingredients list (RIL) for cosmetics, adding 29 new ingredients to the list. Reporting Requiremen...

On 29 July 2024, the California Department of Public Health (CDPH) published its updated reportable ingredients list (RIL) for cosmetics, adding 29 new ingredients to the list.

Reporting Requirements under California Cosmetics Legislation

The California Safe Cosmetics Act of 2005 mandates manufacturers to report products containing carcinogenic ingredients to the CDPH. The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 mandates reporting of certain fragrance allergens after 1 January 2022.

Fragrance Allergen Reporting Thresholds

Fragrance allergens must be reported when present in a rinse-off cosmetic product at a concentration at or above 0.01 percent (100 parts per million) or in a leave-on cosmetic product at a concentration at or above 0.001 percent (10 parts per million).

California Safe Cosmetics Program Chemical List

The California Safe Cosmetics Program (CSCP) has developed a list of chemicals, including those reportable under the CA Safe Cosmetics Act and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act. The list is available here as a downloadable spreadsheet and includes a fourth tab labelled "Summary of Updates" which shows all ingredients that have been added to or removed from the RIL since the last update.

Manufacturers of cosmetic products in California must report fragrance allergens in Annex III of EU Cosmetics Regulation No. 1223/2009, as required by EU Detergents Regulation No. 21 648/2004, by 2026 or 2028 at the latest, or at any time.

Manufacturers must disclose identified allergens to the California Department of Public Health by the deadlines set by EU law, which are 2026 or 2028, but manufacturers may submit earlier.

On July 30, 2024, the U.S. Environmental Protection Agency (EPA) published preliminary 2023 Toxics Release Inventory (TRI) data, covering chemical releases, waste management, and pollution prevention...

On July 30, 2024, the U.S. Environmental Protection Agency (EPA) published preliminary 2023 Toxics Release Inventory (TRI) data, covering chemical releases, waste management, and pollution prevention from more than 20,000 facilities nationwide. This year, 21 new chemicals were added to the TRI list, including nine per- and polyfluoroalkyl substances (PFAS), following the requirements of 2020 National Defense Authorization Act (NDAA).

Introduction

The Toxics Release Inventory (TRI) monitors the disposal and management of hazardous chemicals to protect human health and the environment. U.S. facilities must annually report the quantities of these chemicals they release, recycle, or treat, along with their waste reduction practices. TRI tracks chemicals that have been linked to cancer, serious health issues, or major environmental damage. The current TRI list includes 794 chemicals and 33 chemical categories.

General Information on the 2023 Preliminary Data

The 2023 preliminary data were reported by facilities in relevant industries that manufactured, processed, or used TRI-listed chemicals in quantities exceeding threshold limits during the year. This data enables the public to:

• Determine the number of TRI facilities operating in specific areas, such as ZIP codes.
• Identify the types and quantities of chemicals managed by these facilities.
• Discover whether any facilities have taken pollution prevention measures in the past calendar year.

While the preliminary data have not yet been fully vetted through the TRI data quality process, the TRI-MEweb reporting software used by facilities includes automated checks to reduce errors. EPA is also performing additional quality reviews to address potential issues and will follow up with facilities as needed. A revised dataset incorporating late and updated submissions will be published in October. This updated data will be used to develop the 2023 TRI National Analysis, which is expected to be released in early 2025.

PFAS-Related Information from the 2023 Preliminary Data

Preliminary data show that facilities handled more than 1.5 million pounds of PFAS-related waste in 2023. In response, EPA has finalized a rule requiring more comprehensive reporting of PFAS by removing previous exemptions for low concentrations. The expanded reporting of PFAS quantities is expected to start with the 2024 TRI data.

Newly Reportable PFAS for the Reporting Year 2023 include:

On July 19, 2024, the Biden-Harris Administration took a significant step to address plastic pollution by releasing a new joint strategy to combat plastic pollution entitled "Mobilizing Federal Actio...

On July 19, 2024, the Biden-Harris Administration took a significant step to address plastic pollution by releasing a new joint strategy to combat plastic pollution entitled "Mobilizing Federal Action on Plastic Pollution: Progress, Principles, and Priorities". The strategy, developed by the Interagency Policy Committee on Plastic Pollution and a Circular Economy (IPC), outlines ongoing and proposed federal actions to combat plastic pollution throughout its lifecycle, from raw material extraction to waste management. It emphasizes the elimination of single-use plastics, with the goal of phasing out federal procurement of such items by 2027 and from all federal operations by 2035.

The strategy focuses on 1) progress made in combating plastic pollution, 2) five guiding principles for federal actions, and 3) priority actions to address plastic throughout its lifecycle.

Progress:

Recent EPA regulations on plastic production support the broader strategy to reduce pollution and protect vulnerable communities. Executive Order 14057 aims to eliminate single-use plastics from federal operations by 2035, significantly reducing demand. The federal government is also targeting single-use plastics through procurement policies, with Secretary Debra Haaland's Order 3407 phasing them out by 2032. The Save Our Seas 2.0 Act will improve waste management infrastructure, while the National Oceanic and Atmospheric Administration’s (NOAA) $70 million funding and the U.S. Agency for International Development’s (USAID) Save Our Seas Initiative focus on marine debris cleanup and international efforts.

Principles:

The strategy focuses on building partnerships across all levels of government to address plastic pollution throughout its lifecycle. It prioritizes environmental justice, respects tribal sovereignty by incorporating indigenous knowledge, uses the best available science to guide decisions and updates, and strengthens federal interagency coordination.

Priorities:

1. Assess and Reduce Pollution from Plastic Production:

• Review and update rules, guidance, labeling, or policies under key legislation such as the Clean Air Act, Clean Water Act, and Occupational Safety and Health Act to address pollution from plastics, polymers and related chemicals.
• Use federal resources to collect and analyze data on plastic pollution volumes, effects, and prevention methods.

2. Innovation in Materials and Product Design: 

• Promote research, development, and deployment activities associated with reuse, recycling, and other circular solutions for products reaching the end of their primary use.
• Encourage alignment with and acceptance of international standards (e.g., International Organization for Standardization (ISO) and ASTM International) for performance or design criteria, labeling and recycling specifications for plastic products, both in the U.S. and globally.

3. Decrease the Generation of Plastic Waste:

• Assess the extent of plastic use in federal operations and identify where alternatives are available.
• Develop strategies to replace, reduce, and phase out unnecessary plastic products, including addressing single-use plastics and updating procurement policies.
• Launch a nationwide public awareness campaign to educate Americans on plastic pollution, management, alternatives, and reduction actions.

4. Improve Environmentally Sound Waste Management:

• Support the development, deployment of, and investment in technologies and infrastructure for plastic waste collection, recycling, disposal, source separation, and industrial composting.
• Identify and measure pathways by which plastic pollution enters and persists in the environment.
• Examine and improve U.S. exports of plastic waste and scrap to prevent it from becoming plastic pollution.
• Explore potential ways to illustrate support for U.S. ratification of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal.

5. Inform and Conduct Capture and Removal of Plastic Pollution. The final stage of action addresses existing plastic pollution in terrestrial and aquatic ecosystems:

• Develop standardized methods for the collection, extraction, quantification, and physical and chemical characterization of microplastics and nanoplastics.
• Support the removal and proper disposal of marine debris, plastic pollution and derelict fishing gear.
• Share and deploy best practices, policies, guidance, lessons learned and technologies for trash interception.

On July 22, 2024, Alaska enacted Senate Bill (SB) 67, which phases out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS). The bill automatically became law after the ...

On July 22, 2024, Alaska enacted Senate Bill (SB) 67, which phases out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS). The bill automatically became law after the Governor neither signed nor vetoed it within the designated 22-day period.

Introduction:

Aqueous Film Forming Foam (AFFF), a firefighting foam used primarily on military bases and airports to fight fuel and chemical fires, contains per- and polyfluoroalkyl substances (PFAS). PFAS are a group of over 12,000 chemicals widely used in consumer products, industrial applications, and industrial firefighting foams. Even minimal exposure to PFAS has been associated with severe health issues, including liver and kidney damage, reproductive and developmental harm, immune system impairment, and certain cancers.

Proposed Bill:

The majority of PFAS contamination in Alaskans' drinking water is linked to the dispersive use of PFAS-based industrial firefighting foams at airports and military bases. Starting January 1, 2025, a ban on AFFF and a disposal program will be implemented. The new legislation mandates a transition to PFAS-free foams and authorizes the removal of PFAS firefighting foams from villages with populations of less than 2,000.

Rather than having the state directly handle the collection and disposal of PFAS in rural villages, the state will reimburse these communities for the associated costs. This includes expenses related to replacing equipment potentially contaminated by PFAS foams. However, these foams may still be used if required by federal law, according to the bill.

Exemptions:

Oil and gas facilities, which are at risk of especially intense fires will be permitted to use existing foams until the state fire marshal officially identifies an alternative firefighting foam that is both PFAS-free and proven to be safe and effective. Once that determination is made, the state fire marshal is expected to enact a regulation mandating these facilities to switch to PFAS-free foams, as required by the bill.

On July 16, 2024, the US Environmental Protection Agency (EPA) finalized the Integrated Risk Information System (IRIS) Toxicological Review for perfluorodecanoic acid (PFDA) and related salts. The Age...

On July 16, 2024, the US Environmental Protection Agency (EPA) finalized the Integrated Risk Information System (IRIS) Toxicological Review for perfluorodecanoic acid (PFDA) and related salts. The Agency has raised the acceptable reference dose (RfD) for PFDA. The final review tripled the proposed risk threshold for PFDA, indicating that any subsequent risk management measures will be less stringent.

Introduction:

Perfluorodecanoic acid (PFDA, CASRN 335-76-2) and its related salts, members of the per- and polyfluoroalkyl substances (PFAS) group, are known for their resistance to hydrolysis, photolysis, and biodegradation, resulting in persistent environmental contamination. EPA's Integrated Risk Information System (IRIS) review covers PFDA and its fully dissociating salts, such as ammonium perfluorodecanoate (CASRN 3108-42-7), and sodium perfluorodecanoate (CASRN 3830-45-3) which are expected to fully dissociate in aqueous solutions at pH ranging from 4 to 9 (e.g., in the human body).

Human studies indicate that PFDA exposure may cause liver, immune, developmental, and reproductive effects, with potential impacts on cardiometabolic and neurodevelopmental health. The IRIS program is developing a series of five PFAS assessments at the request of EPA to address these concerns.

Final Report:

The reference dose (RfD) for PFDA remains significantly lower than the RfDs for PFBA and PFHxA, which were finalized in last year's IRIS assessments. It is also comparable to the preliminary RfDs for PFHxS and PFNA, which are currently in the draft assessment stage. The final PFDA assessment used the same studies, hazard endpoints, points of departure (PODs) and uncertainty factors as the draft assessment to determine the overall RfD.

Organ-specific RfDs for health effects compared with the 2023 draft review of PFDA:

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a compliance guide for the recently enacted methylene chloride risk management rule under the Toxic Substances Control Act (TSCA...

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a compliance guide for the recently enacted methylene chloride risk management rule under the Toxic Substances Control Act (TSCA). The guide is intended to assist industry, workers, and stakeholders to comply with the regulations designed to prevent injuries, illnesses, and deaths.

In April 2024, EPA finalized a ban on most uses of methylene chloride, citing its links to various cancers, neurotoxicity, and other severe health risks. The regulation, effective from July 8, 2024, aims to protect public health while allowing essential uses to continue safely under a robust Workplace Chemical Protection Program (WCPP).

Affected Stakeholders

The methylene chloride rule affects anyone involved in the manufacturing, importing, processing, distributing, using, or disposing of methylene chloride or products containing it. This includes the use of methylene chloride in laboratories.

Workplace Chemical Protection Program

A Workplace Chemical Protection Program (WCPP) is required in order to continue 13 conditions of use of methylene chloride. These uses include:

1. Domestic manufacturing

2. Import

3. Processing as a reactant

4. Processing in incorporation into formulation, mixture, or reaction product

5. Processing in repackaging

6. Processing in recycling

7. Use as a laboratory chemical.

8. Use in paint and coating removers for safety-critical, corrosion-sensitive components of aircraft and spacecraft

9. Use as a bonding agent for solvent welding

10. Industrial and commercial use as a processing aid

11. Use in the manufacture of plastic and rubber products

12. Use as a solvent that becomes part of a formulation or mixture where the formulation or mixture will be used inside a manufacturing process and the solvent (methylene chloride) will be reclaimed

13. Disposal

The WCPP requires owners and operators of facilities using methylene chloride to comply with new inhalation exposure limits, including a maximum of 2 ppm over an 8-hour period, and must create and enforce an exposure control plan.

Key Phase-Out and Information Deadlines:

• May 5, 2025: Prohibition on distributing methylene chloride for consumer use.
• April 28, 2026: Prohibition on most commercial uses.
• October 7, 2024: Deadline for manufacturers to update Safety Data Sheets (SDS) to spread awareness throughout the supply chain.
• December 4, 2024: Deadline for processors and distributors to update SDSs.

The compliance guide includes special attention to the interests and needs of small businesses. More information on the implemented regulation can be accessed here.