USA Regulatory News

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.

*Source

The Toxic Substances Control Act (TSCA) regulates chemical manufacturing, importation, and use in the U.S. Since its 2016 amendment under the Lautenberg Chemical Safety Act (New TSCA), the Environment...

The Toxic Substances Control Act (TSCA) regulates chemical manufacturing, importation, and use in the U.S. Since its 2016 amendment under the Lautenberg Chemical Safety Act (New TSCA), the Environmental Protection Agency (EPA) has expanded chemical testing, risk-based assessments, and regulatory actions to protect human health and the environment.

In 2024, EPA updated the Toxics Release Inventory (TRI) data, tracking over 20,000 facilities and highlighting zinc, lead, and PFAS releases. The TSCA Inventory now includes 86,741 substances, with 900 chemicals moved from confidential to public status. New regulations for PBT chemicals DecaBDE and PIP (3:1) introduced stricter safety measures, water release bans, and phase-out plans. EPA also proposed new Significant New Use Rules (SNURs), requiring notification before new chemical applications.

To enhance workplace safety, the Occupational Safety and Health Administration (OSHA) aligned the Hazard Communication Standard (HCS) with GHS 7, updating labeling, hazard classification, and safety data sheets. EPA expanded the Safer Chemical Ingredients List (SCIL) with 27 new chemicals, promoting safer alternatives. Additionally, PFAS regulations were tightened, classifying them as hazardous constituents and removing previous reporting exemptions.

These updates reflect New TSCA’s focus on stricter chemical oversight, risk-based regulation, and stronger transparency requirements, ensuring greater environmental and public health protections in the U.S.

Key News from 2024

EPA Releases Updated 2023 Toxics Release Inventory (TRI) Data

EPA has released updated data for the 2023 Toxics Release Inventory (TRI), which details toxic chemical waste management, releases, and pollution prevention activities across more than 20,000 industrial and federal facilities. The new data provides insights into chemical releases and waste management practices, helping communities and regulatory agencies track environmental impact. Read more here.

EPA Updates TSCA Inventory with New Chemical Listings

The Toxic Substances Control Act (TSCA) Inventory has been updated, now listing 86,741 chemical substances, with 42,293 classified as active in commerce. This update improves transparency in chemical manufacturing and includes regulatory data on commercial activity and significant new use requirements. Approximately 900 previously confidential chemicals have now been made public as part of ongoing efforts to enhance chemical safety. Read more here.

EPA Proposes Significant New Use Rules (SNURs) for Chemicals

EPA has proposed new Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemicals previously deemed “not likely to present an unreasonable risk”. Under these rules, companies must notify EPA at least 90 days before manufacturing or processing these chemicals for new applications. This allows EPA to review potential health and environmental risks before the chemicals enter widespread use. Read more here.

Compliance Deadlines for the Updated Hazard Communication Standard

The updated Hazard Communication Standard establishes deadlines for compliance, requiring manufacturers to update labels and safety data sheets for substances by 2026 and for mixtures by 2027. Employers have additional time to update workplace training and compliance measures, with final deadlines extending to 2028. Special provisions have been introduced for labeling small containers, particularly those under 100 milliliters, to ensure that workers can still access critical hazard information. Read more here.

OSHA Updates Hazard Communication Standard to Align with GHS 7

The Occupational Safety and Health Administration (OSHA) has updated its Hazard Communication Standard (HCS) to align with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 7). The revised standard introduces changes to hazard classification, safety data sheets, and labeling requirements to improve worker safety. Chemical manufacturers and importers must now include harmonized signal words, pictograms, and hazard statements on their labels, along with updated classification criteria for mixtures Read more here.

Key Dates for 2025-2026

On May 20, 2024, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published an updated Hazard Communication Standard (HCS). OSHA is adopting the new requirements by January 19, 2026, for substances and by July 19, 2027 for mixtures.

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) released its final risk evaluation for diisodecyl phthalate (DIDP), concluding that it poses an unreasonable risk to human health, pa...

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) released its final risk evaluation for diisodecyl phthalate (DIDP), concluding that it poses an unreasonable risk to human health, particularly to unprotected female workers of reproductive age who use spray products such as adhesives, paints, and coatings. The main concern is DIDP's potential to cause developmental toxicity, along with liver damage.  

DIDP is commonly used as a plasticizer in PVC, building materials, and automotive products, but EPA did not assess risks for uses exempted from TSCA, such as cosmetics, medical devices, and food contact materials (FCMs). 

DIDP Uses and Associated Risks  

EPA conducted a risk evaluation of DIDP at the manufacturer’s request under TSCA and approved it in 2019. During manufacture or used, DIDP can be released into water, settling in sediment or into the air where it attaches to dust particles. Indoors, DIDP can be released from products over time and adhere to dust, posing risks if inhaled or ingested. 

The evaluation found that DIDP poses a risk of developmental toxicity and liver damage, but did not find sufficient evidence of a cancer risk or male reproductive system harm, known as "phthalate syndrome.". Therefore, DIDP is excluded from the cumulative risk analysis for other phthalates linked to phthalate syndrome. 

Workers at Risk from Spray-Applied DIDP Products 

EPA identified an unreasonable risk of injury to female workers of reproductive age exposed to DIDP in six conditions of use, particularly from spray-applied products such as adhesives, sealants, paints, and coatings, which can create high concentrations of DIDP mist. This exposure represents about 1% of U.S. DIDP production. However, EPA found no unreasonable risks to consumers, the general population, or the environment. 

Regulatory Scope and Next Steps 

Uses not covered by TSCA, such as in food additives and cosmetics, were not evaluated by the EPA. Although past assessments suggest that dietary exposure is the primary risk from DIDP for certain groups, EPA's findings cannot be applied to uses of DIDP not covered by TSCA. 

Additional Information  

The list of conditions that contribute significantly to unreasonable risk are available here: 

EPA Finalizes TSCA Risk Evaluation for Diisodecyl Phthalate (DIDP) | US EPA