USA Regulatory News

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 

On January 6, 2025, the U.S Environmental Protection Agency (EPA) released a draft risk evaluation for dicyclohexyl phthalate (DCHP) under the Toxic Substances Control Act (TSCA) for public comment. A...

On January 6, 2025, the U.S Environmental Protection Agency (EPA) released a draft risk evaluation for dicyclohexyl phthalate (DCHP) under the Toxic Substances Control Act (TSCA) for public comment. Alongside this, EPA published technical support documents and a cumulative risk analysis for several phthalates. This update focuses on the potential health risks of exposure to DCHP, particularly for workers, and its cumulative effects when combined with other phthalates. Public comments will be accepted for 60 days after publication. 

Draft Risk Evaluation for DCHP 

DCHP is widely used as a plasticizer and stabilizer in products such as polyvinyl chloride (PVC), adhesives, sealants, paints, and coatings.  

Key Findings:

• Unreasonable Risks to Workers: EPA’s preliminary findings indicate that DCHP poses unreasonable risks to human health, especially to workers exposed through inhalation. Potential health effects include harm to the developing male reproductive system. 

• Nine Key Conditions of Use Contributing to Risk: Manufacturing, industrial processing, and commercial applications in adhesives, paints, coatings, and printing inks. 

• No Environmental Risk: On evaluation it was determined that DCHP does not pose unreasonable risk to the environment or the general population. 

Exposure Pathways: 

• Workplace Exposure: Workers may be exposed through manufacturing and product use. 

• Environmental Exposure: DCHP may be released into water, where it settles in sediment. If released into air, it can adhere to dust particles, which may lead to inhalation or ingestion indoors over time. 

Excluded Uses:  

• Food contact materials were not assessed because they are exempt under TSCA. 

Cumulative Risk Analysis for other Phthalates 

EPA also conducted a cumulative risk analysis for six other phthalates: DCHP (CAS no. 84-61-7), benzyl butyl phthalate (BBP) (CAS no. 85-68-7), dibutyl phthalate (DBP) (CAS no. 84-74-2), di(2-ethylhexyl) phthalate (DEHP) (CAS no. 117-81-7), diisobutyl phthalate (DIBP) (CAS no. 84-69-5), and di-isononyl phthalate (DINP) (CAS no. 28553-12-0). This approach evaluates the combined health effects of these chemicals, in the similar manner as other American institutes and surveys have done before (NHANES, NASEM, CPSC) this approach evaluates the combined health effects of these chemicals, , leading to simultaneous exposures. 

Phthalate Syndrome & Relative Potency Factor (RPF) Approach

Animal studies have shown that prenatal exposure to these phthalates can cause adverse developmental effects, collectively known as phthalate syndrome,  including: 

•  Reduced fetal testicular testosterone 

• Male reproductive tract malformations  

• Reduced fertility 

EPA has also used the RPF approach to evaluate cumulative risks, focusing on the shared hazard of reduced fetal testicular testosterone, which is more sensitive than assessing individual chemicals separately. 

Technical support document for DIBP, DBP, DEHP and BBP

EPA has released key technical documents to support the cumulative risk analysis and future phthalate evaluations: 

• Physical chemistry and environmental fate and transport technical support documents to provide details on the properties and environmental behavior of phthalates. 

• Human Health (Non-Cancer) Hazards & Environmental Hazards to establish health risk values for exposure assessment and to identify the potential risks to the environment and safe exposure limits. 

Key Conditions of Use for DCHP 

EPA categorized DCHP’s conditions of use into two groups: 

Conditions Contributing to Unreasonable Risk:

• Manufacturing: Domestic production. 

• Processing: Used in adhesives, paints, coatings, and printing inks. 

• Industrial Uses: Includes finishing agents in cellulose film production. 

• Commercial Uses: Found in screen printing inks and coatings. 

Conditions Not Contributing to Unreasonable Risk: 

• Manufacturing: Importing. 

• Processing: Recycling and repackaging. 

• Distribution: In commerce or as part of low exposure products like adhesives and building materials. 

• Consumer Uses: Adhesives, coatings, and general articles with minimal direct exposure risks. 

What’s next? 

EPA has opened a 60-day public comment period for the DCHP draft risk evaluation (Docket: EPA-HQ-OPPT-2018-0504) on regulations.gov. Preliminary dockets for BBP, DBP, DEHP, and DIBP are open, with formal 60-day comment periods starting upon release of the draft evaluations. 

Phthalate Dockets: 

DIBP: EPA-HQ-OPPT-2018-0434 

DBP: EPA-HQ-OPPT-2018-0503 

DEHP: EPA-HQ-OPPT-2018-0433 

BBP: EPA-HQ-OPPT-2018-0501 

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) expanded the Toxics Release Inventory (TRI) by adding nine per- and polyfluoroalkyl substances (PFAS). The nine PFAS were added to th...

On January 3, 2025, the U.S. Environmental Protection Agency (EPA) expanded the Toxics Release Inventory (TRI) by adding nine per- and polyfluoroalkyl substances (PFAS). The nine PFAS were added to the TRI list as part of the Fiscal Year 2020 National Defense Authorization Act (NDAA), which mandates annual updates based on specified EPA activities. For the 2025 reporting year, facilities are required to track and submit reports on their use, release, or waste management of these PFAS by July 1, 2026, bringing the total number of PFAS subject to TRI reporting to 205. 

TRI data helps communities, organizations, and agencies track local chemical management, supporting transparency, accountability, and informed decision-making for families, workers, and communities nationwide. 

New additions 

The 2020 NDAA provision automatically adds PFAS to the TRI list after the agency finalizes their toxicity values.  

The nine PFAS which were added for 2025 after EPA finalized toxicity values in 2024, with identities not marked as confidential are: 

• Ammonium perfluorodecanoate (PFDA NH4) (CAS no. 3108-42-7) 

• Sodium perfluorodecanoate (PFDA-Na) (CAS no. 3830-45-3) 

• Perfluoro-3-methoxypropanoic acid (CAS no. 377-73-1) 

• 6:2 Fluorotelomer sulfonate acid (CAS no. 27619-97-2) 

• 6:2 Fluorotelomer sulfonate anion (CAS no. 425670-75-3) 

• 6:2 Fluorotelomer sulfonate potassium salt (CAS no. 59587-38-1) 

• 6:2 Fluorotelomer sulfonate ammonium salt (CAS no. 59587-39-2) 

• 6:2 Fluorotelomer sulfonate sodium salt (CAS no. 27619-94-9) 

• Acetic acid, [(γ-ω-perfluoro-C8-10-alkyl)thio] derivatives., Bu esters (CAS no. 3030471-22-5) 

Review of confidential business information 

Under NDAA Section 7321(e), EPA must review Confidential Business Information (CBI) claims before adding a PFAS to the TRI list if its identity is protected under 5 U.S.C. 552(a). Starting January 1, 2025, facilities must track activities involving these PFAS, with reports due by July 1, 2026. All PFAS on the TRI list, now 205 in total, are classified as chemicals of special concern, removing small concentration reporting exemptions.

On January 2, 2025, the U.S. Environmental Protection Agency (EPA) finalized it's risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA). The Agency concluded that formaldehyde...

On January 2, 2025, the U.S. Environmental Protection Agency (EPA) finalized it's risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA). The Agency concluded that formaldehyde poses an unreasonable risk of harm to human health under various conditions of use. Widely present in everyday products and the environment, formaldehyde has been linked to significant health risks, especially for workers and consumers exposed over time. 

Understanding Formaldehyde Exposure 

Formaldehyde (CAS No 50-00-0) is a common industrial chemical found in products such as adhesives, paints, textiles, and construction materials. It is also a byproduct of combustion processes such as car emissions and stove operations and is naturally released during the decomposition of organic materials. 

Due to its widespread presence, most people are exposed to formaldehyde in both indoor and outdoor environments, primarily through inhalation or skin contact. Common sources include composite wood furniture, adhesives, and various household products. Workers in manufacturing and processing environments are at the greatest risks, particularly without adequate protective equipment. Additionally, consumers who use products such as crafting supplies, automotive care products, or new leather goods may encounter health hazards, particularly when the products are new and emit higher concentrations of formaldehyde. 

Health Impacts Identified by EPA 

EPA's evaluation highlighted both short-term and long-term health risks: 

• Short-term (acute) exposure can cause sensory irritation, including inflammation of the eyes and respiratory tract, which typically resolves after exposure ends. 

• Long-term (chronic) exposure is linked to reduced lung function, increased risk of asthma and allergies, and cancer. Formaldehyde is a known carcinogen, with prolonged inhalation posing significant cancer risks, especially for workers. Skin contact with materials containing formaldehyde can also trigger allergic reactions. 

Conditions of Use and Findings 

EPA examined 68 conditions of use (COU) for formaldehyde and found that 50 occupational and 8 consumer COUs contribute significantly to unreasonable risks. While some risks were identified from chronic exposure to air near industrial facilities, they were deemed minimal due to natural degradation, modeling uncertainties, and upcoming regulations. Additionally, formaldehyde poses no significant environmental risks as it breaks down quickly in water, soil, and sediment, minimizing its impact on plants, animals, and ecosystems. 

What’s next? 

EPA will now initiate the risk management process under TSCA Section 6 to address the risk of formaldehyde. This will include proposing new rules to protect workers and consumers and ensure safer chemical management across industries. 

On December 12, 2024, the U.S. Environmental Protection Agency (EPA) introduced a final rule under section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates manufacturers and importe...

On December 12, 2024, the U.S. Environmental Protection Agency (EPA) introduced a final rule under section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates manufacturers and importers of 16 specific chemicals to report data from unpublished health and safety studies to EPA. The information gathered will support EPA’s efforts to prioritize, evaluate, and manage chemical risks, to protect human health and the environment.

In addition to health and safety data, manufacturers are required to submit unpublished studies on environmental effects and exposure levels for occupational, general population, and consumer settings. The chemicals listed under this rule are:

1. 4,4-Methylene bis(2-chloraniline) (MBOCA) (CASRN 101-14-4)
2. 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9)  
3. Acetaldehyde (CASRN 75-07-0)
4. Acrylonitrile (CASRN 107-13-1)  
5. Benzenamine (CASRN 62-53-3)
6. Benzene (CASRN 71-43-2)
7. Bisphenol A (CASRN 80-05-7)  
8. Ethylbenzene (CASRN 100-41-4)
9. Naphthalene (CASRN 91-20-3)
10. Vinyl Chloride (CASRN 75-01-4)
11. Styrene (CASRN 100-42-5)
12. Tribromomethane (Bromoform) (CASRN 75-25-2) 
13. Triglycidyl isocyanurate; (CASRN 2451-62-9) 
14. Hydrogen fluoride (CASRN 7664-39-3)
15. N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8)               
16. 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5)

HISTORY:

EPA mandates companies manufacturing or importing the listed chemicals, whether as pure substances, mixtures, or components in products, to submit health and safety studies. This rule aims to enhance EPA’s understanding of environmental and toxic exposures, ensuring clean air and water for all communities.

The Toxic Substances Control Act of 1976 gives EPA the authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are excluded from TSCA, including food, drugs, cosmetics and pesticides.

CHEMICALS UNDERGOING PRIORITIZATION:

The chemicals listed in the final rule are of particular interest because they are either undergoing prioritization for high-priority designation for risk evaluation or are expected to be candidates in the near future. In July 2024, EPA proposed to designate five chemicals as High-Priority Substances: MBOCA, Acetaldehyde, Acrylonitrile, Benzenamine, and Vinyl Chloride, all linked to cancer and used in plastic production.

Additionally, 11 chemicals are slated for the next round of prioritization beginning in December 2024, including Benzene, Bisphenol A, Ethylbenzene, Styrene, and 6PPD-quinone. Eight of these are part of the 2014 TSCA Work Plan, a list of chemicals identified for further assessment based on hazards and exposure potential.

6PPD reacts with ozone to form 6PPD-quinone, a chemical highly toxic to coho salmon in stormwater. EPA is collecting more data on both substances under TSCA, with public comments on associated risks due by January 21, 2025. Hydrogen fluoride, while not on the TSCA Work Plan, is under review due to stakeholder interest. This rule will expand EPA’s knowledge for potential prioritization.

The final rule underscores EPA’s commitment to transparency and data-driven chemical management. Stakeholders are encouraged to review the final rule for details.