USA Regulatory News

The U.S. Environmental Protection Agency (EPA) has finalized its Interim Decision on Ethylene Oxide (EtO), a widely used pesticide and sterilizing agent. EPA announced stronger protections to reduce c...

The U.S. Environmental Protection Agency (EPA) has finalized its Interim Decision on Ethylene Oxide (EtO), a widely used pesticide and sterilizing agent. EPA announced stronger protections to reduce cancer risk for workers and communities. EtO is used to sterilize approximately 50% of U.S. medical devices and 30% of dried herbs and spices. 

Health Risks of Ethylene Oxide 

EtO is a known human carcinogen, linked to lymphocytic leukemia, breast cancer, non-Hodgkin lymphoma, and myeloma. Workers at sterilization facilities and individuals living or working near these facilities are at the greatest risk of exposure. 

Comprehensive Risk Mitigation 

This Interim Decision complements the 2024 National Emissions Standards for Hazardous Air Pollutants (NESHAP), creating a combined approach to address EtO pollution under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Air Act. EPA’s combined actions target EtO-related cancer risks, improving safety for communities and workers while ensuring the availability of sterilized medical supplies. 

Key Measures for Commercial Sterilizers 

Phased Worker Exposure Limits: 

 EPA is implementing a reduction in permissible worker exposure to ethylene oxide (EtO) in phases, lowering the limit to 0.5 ppm by 2028, 0.25 ppm by 2030, and 0.1 ppm by 2035. These limits are significantly stricter than the current OSHA standard of 1 ppm. 

New Sterilization Standards: 

 A maximum EtO concentration of 600 mg/L will be required for new medical device sterilization cycles within 10 years. If a higher concentration is needed due to device design, facilities must provide justification and maintain supporting documentation. 

Use Cancellations: 

EPA has banned the use of EtO for museum and archival materials, cosmetics, musical instruments, and beekeeping equipment immediately. Additionally, the agency will phase out the use of EtO for specific dried herbs and spices where safer, effective alternatives exist. 

Facility Safety Improvements: 

Commercial sterilization facilities must separate HVAC systems to reduce EtO exposure in areas such as offices. Continuous air monitoring and breathing zone testing will be required to assess exposure levels. Workers performing high-risk tasks such as handling EtO containers must use respirators for protection. 

Healthcare Facility Requirements: 

Healthcare facilities that use more than 10 pounds of EtO per year must install a batement devices to reduce emissions. EtO used in these facilities must be vented through exterior ventilation stacks to limit exposure. EPA considers the community risk from healthcare facilities to be minimal, given their comparatively low volumes of EtO use. 

Next Steps 

Registrants are required to submit label amendments within 60 days of publication of the Interim Decision. New safety measures will be implemented over a 2–10 year period to balance health protections with supply chain stability. EPA will also issue a Data Call-In (DCI) to collect real-world data on worker exposure at commercial sterilizers and warehouses. The agency plans to reassess the decision in eight years, which is earlier than the typical 15-year pesticide review cycle. 

In response to stakeholder requests, the U.S. Environmental Protection Agency (EPA) has announced an extension of the reporting deadlines under the Toxic Substances Control Act (TSCA) Health and Safet...

In response to stakeholder requests, the U.S. Environmental Protection Agency (EPA) has announced an extension of the reporting deadlines under the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting Rule. The rule mandates manufacturers and importers of 16 specified chemical substances to submit lists and copies of unpublished health and safety studies to EPA. 

Extended Reporting Deadline 

The original reporting deadline for all 16 chemical substances was March 13, 2025. However, EPA has now extended the deadlines as follows: 

• Vinyl chloride – New deadline: June 11, 2025 

• Remaining 15 chemical substances – New deadline: September 9, 2025 

These extensions are intended to provide manufacturers and importers with additional time to gather and submit the required data to ensure compliance with the rule. 

For background on EPA’s health and safety data reporting for the 16 chemicals under TSCA, see the original news here. 

The U.S. Environmental Protection Agency has extended the public comment periods for two key chemical evaluations under the Toxic Substances Control Act (TSCA), allowing stakeholders additional time t...

The U.S. Environmental Protection Agency has extended the public comment periods for two key chemical evaluations under the Toxic Substances Control Act (TSCA), allowing stakeholders additional time to provide feedback on regulatory decisions for C.I. Pigment Violet 29 (PV29) and vinyl chloride. 

Extended Comment Period for C.I. Pigment Violet 29    

On January 14, 2025, EPA released a proposed risk management rule for C.I. Pigment Violet 29 (PV29), a chemical commonly used in paints, coatings, and plastics. The public comment period was originally scheduled to close on February 28, 2025. However, the agency has now extended the deadline by 60 days, to April 29, 2025. 

The extension is intended to give stakeholders, including industry representatives, environmental groups, and the public, more time to review the proposed regulations and submit their comments. Those interested can provide input through the official docket (EPA-HQ-OPPT-2021-0277) at www.regulations.gov. 

Vinyl Chloride Risk Evaluation Comment Period Extension   

Similarly, EPA has extended the comment period for the draft scope document for the risk evaluation of vinyl chloride, a chemical used primarily in the production of PVC plastics. The draft scope document was initially released with the original comment period set to close on March 3, 2025. The extension grants stakeholders an additional 30 days, extending the deadline to April 2, 2025. 

EPA encourages interested parties to submit feedback on the draft risk evaluation through the docket (EPA-HQ-OPPT-2018-0448) at www.regulations.gov. 

For more details on EPA’s draft decision for C.I pigment violet, see EPA Proposes Rule to Protect Workers from Exposure to C.I. Pigment Violet 29. 

And for vinyl chloride, see our article EPA Classifies Five Substances as High-Priority for Risk Evaluation Under Toxic Substances Control Act. 

The U.S. Environmental Protection Agency (EPA) has extended the public comment period for its draft TSCA risk evaluation for 1,3-butadiene. Originally set to close on February 3, 2025, the deadline is...

The U.S. Environmental Protection Agency (EPA) has extended the public comment period for its draft TSCA risk evaluation for 1,3-butadiene. Originally set to close on February 3, 2025, the deadline is now extended to March 5, 2025, to allow additional time for stakeholders to provide feedback.   

Key Findings of the Draft TSCA Risk Evaluation 

On December 2, 2024, the U.S. EPA released a draft risk evaluation for 1,3-butadiene (CAS No. 106-99-0) under the Toxic Substances Control Act (TSCA) for public comment and peer review by the Science Advisory Committee on Chemicals (SACC). EPA in its risk evaluation determined that 1,3-butadiene poses an unreasonable risk of injury to human health from inhalation exposure to workers and to the general population (including fenceline communities) which is associated with several health effects.   

1,3-Butadiene 

1,3-butadiene is a colorless, highly flammable gas with a mild odor similar to gasoline. It is used primarily in the manufacture of plastics, synthetic rubber (including tires), adhesives, fuels, lubricants, paints, and coatings. The chemical is commonly released into the air during its production and use, with minimal releases to land or water. Beyond industrial exposure, people may also encounter 1,3-butadiene in vehicle exhaust, tobacco smoke, and burning wood. 

Identified Health Risks  

Workers and Occupational Exposure:  

• Workers in manufacturing and processing facilities face significant health risks from inhaling 1,3-butadiene and maintenance and laboratory technicians are particularly vulnerable due to non-routine handling. Health effects include reduced birth weight, blood and immune system diseases, and leukemia. 

Fenceline Communities and the General Population:  

• For people living near industrial facilities long-term exposure from air emissions can lead to serious chronic health effects over time through inhalation. 

Minimal Consumer and Environmental Risk:  

• Consumer exposure is low since only trace amounts of 1,3-butadiene are found in products. The draft evaluation also concludes that there is no unreasonable environmental risk, as 1,3-butadiene does not have a significant impact on land or water. 

Uses of 1,3-Butadiene 

1,3-butadiene uses that pose a significant risk: 

• Manufacturing and processing in industries such as rubber, plastics, adhesives, fuels, and coatings. 

• Handling, repackaging, and disposal of 1,3-butadiene. 

• Recycling and laboratory use. 

Uses that pose low or no risk: 

• Consumer and industrial use in fuels 

• Automotive products 

• Lubricants 

• Packaging 

• Furniture 

• Toys  

• Distribution in commerce 

Public and Peer Review Comments 

EPA was previously accepting public comments for 60 days after the draft evaluation but has extended the comment period from February 3, 2025, to March 5, 2025. Public comments can be submitted to docket EPA-HQ-OPPT-2024-0425 on www.regulations.gov until the new deadline. 

A preparatory public meeting to discuss the scope of the evaluation scheduled for February 4 and the virtual SACC peer review meeting to review public comments and finalize recommendations was scheduled for February 25-28, 2025, but EPA is now rescheduling the February peer review meetings to review additional comments and will announce new dates soon. 

The California Office of Environmental Health Hazard Assessment (OEHHA) has expanded the Proposition 65 listing for Bisphenol S (BPS) to include male reproductive toxicity, effective January 3, 2025. ...

The California Office of Environmental Health Hazard Assessment (OEHHA) has expanded the Proposition 65 listing for Bisphenol S (BPS) to include male reproductive toxicity, effective January 3, 2025.  

BPS Use and Health Concerns 

BPS (CAS No. 80-09-1) is commonly used in plastics, food packaging, and thermal paper receipts, often as a substitute for Bisphenol A (BPA). However, scientific findings suggest that BPS, like BPA, may disrupt hormone function and harm reproductive health. 

The Proposition 65 List 

Proposition 65 requires California to maintain a list of chemicals known to cause cancer, reproductive harm, or both. These chemicals may be present in pesticides, household products, food, drugs, dyes, and solvents, as well as in manufacturing and construction materials. Some are also by-products of chemical processes. 

New Toxicity Endpoint Added 

BPS was first added to the Proposition 65 list on December 29, 2023, due to its effects on female reproductive toxicity. Following a determination by the Developmental and Reproductive Toxicant Identification Committee (DARTIC), acting as the State’s Qualified Experts published on December 12, 2024, the OEHHA expanded the listing to include male reproductive toxicity. 

This update strengthens California’s efforts to protect public health by raising awareness of the potential risks of BPS exposure. From January 3, 2026, businesses are required to provide warnings if their products contain high levels of BPS that could harm male reproductive health. 

The Washington State Department of Ecology is proposing new rules to restrict the use of formaldehyde and formaldehyde releasers in cosmetic products. This is because formaldehyde (CAS No 50-00-0) is ...

The Washington State Department of Ecology is proposing new rules to restrict the use of formaldehyde and formaldehyde releasers in cosmetic products. This is because formaldehyde (CAS No 50-00-0) is a recognized carcinogen and irritant which poses health risks through skin absorption and inhalation. Restricting consumer use is essential to limit human health effects. This initiative aims to enhance the safety of cosmetic products and is currently open for public feedback. Public hearings are scheduled for March 31 and April 1, 2025.  

Scope of the Proposed Regulations 

The proposed rules will affect cosmetics manufacturers, distributors, retailers, and cosmetology businesses operating in Washington State. The restrictions apply to cosmetic products sold both online and in physical stores, as well as those used in professional services. 

Implementation Timeline 

The proposed rule, if adopted, is set to become effective on January 1, 2027. There are 28 formaldehyde releasers on the list and the full list can be found here.  

Comments 

Comments on the proposed rule can be submitted from February 6, 2025, at 12:00 a.m. PDT until April 11, 2025, at 11:59 p.m. PDT.  

Online comments can be submitted here. 

The California Department of Pesticide Regulation (DPR) has proposed adding chitosan to the list of active chemicals authorised in exempted minimum-risk pesticides. This approach is consistent with a ...

The California Department of Pesticide Regulation (DPR) has proposed adding chitosan to the list of active chemicals authorised in exempted minimum-risk pesticides. This approach is consistent with a recent action by the United States Environmental Protection Agency (EPA).

Regulation and background

The DPR's proposed change to Title 3 of the California Code of Regulations (3 CCR) section 6147(a)(5)(A) is consistent with EPA's inclusion of chitosan in Title 40, Code of Federal Regulations (40 CFR) section 152.25(f)(1), which was published in the Federal Register on November 8, 2022.

Updates

This change will affect pesticide registration efforts in California. Chitosan, a naturally occurring biopolymer derived from crustacean shells, has shown promise as a biopesticide. Its addition the list of exempted components will speed up the registration procedure for chitosan-based products.

The DPR believes this action will benefit Californians by boosting the availability of alternatives to traditional pesticides, potentially resulting in reduced regulatory burdens for manufacturers and lower costs for consumers. The state also expects to see an increase in the manufacture and availability of chitosan-based insecticides.

Comment Period

Interested parties are encouraged to provide written comments on the proposed action by March 17, 2025. Although no public hearings are presently scheduled, a public hearing will be scheduled if requested in writing to the DPR at least 15 days before the end of the comment period. The DPR's contact information for sending comments is available on its website.

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