USA Regulatory News

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) 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 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.

On December 20, 2024, the U.S. Environmental Protection Agency (EPA) proposed its 8th rule under TSCA to protect workers from inhaling C.I. Pigment Violet 29 (PV29) (CAS 81-33-4), a chemical that has ...

On December 20, 2024, the U.S. Environmental Protection Agency (EPA) proposed its 8th rule under TSCA to protect workers from inhaling C.I. Pigment Violet 29 (PV29) (CAS 81-33-4), a chemical that has been linked to lung damage. The rule would mandate respiratory protection and workplace cleaning for PV29 in dry powder form. 

Overview of C.I. Pigment Violet 29 

PV29 is a pigment manufactured in powder, slurry or paste forms. Applications include the manufacture of watercolours, acrylic paints, merchant ink for commercial printing, and dyes for paints, coatings, plastics, and rubber products. It is used in industries such as automotive manufacturing and industrial carpeting production. 

Health Risks Identified in EPA's 2021 Risk Evaluation 

EPA’s risk evaluation in 2021 determined that PV29 presents an unreasonable risk to health under its conditions of use. Inhalation of PV29 dry powder can cause lung toxicity, which impairs the ability of the lungs to supply oxygen to the body 

Risk Differentiation 

EPA has concluded that PV29 already incorporated into paints, coatings, or other materials no longer poses an inhalation risk because it lacks the physical properties of the dry powder form. 

Proposed Worker Protections 

EPA is proposing minimum respiratory protection requirements for workers exposed to dry powder PV29 and the implementation of cleaning protocols for equipment and work areas where PV29 is handled to minimize exposure risks.  The rule will mandate worker protections for the following uses of dry powder PV29: 

1. Paints and Coatings: Incorporation into formulations, mixtures, or reaction products for paints and coatings. 

2. Plastic and Rubber Products: Incorporation into formulations, mixtures, or reaction products for plastic and rubber products. 

3. Pigment Manufacturing: Use as an intermediate in creating or adjusting the colour of other perylene pigments. 

4. Automotive Industry: Industrial and commercial use in automobile paints and coatings, including original equipment manufacturing and refinishing. 

5. Coatings and Basecoats: Industrial and commercial use in coatings and basecoats for paints and coatings. 

6. Commercial Printing: Industrial and commercial use in merchant ink for commercial printing. 

7. Lifecycle Processes: Domestic manufacturing, import, recycling, and disposal of PV29. 

Public Participation and Comments on the Proposed Rule 

EPA encourages the public and stakeholders to review and comment on the proposed rule. The Agency seeks feedback on how practical and effective the proposed worker protection rules are, especially from stockholders. The public can submit comments for 45 days following the publication of rule in the Federal Register.

On December 18, 2024, the U.S. Environmental Protection Agency (EPA) announced its decision to formally classify five known or suspected carcinogens as High-Priority Substances (HPS) for risk evaluati...

On December 18, 2024, the U.S. Environmental Protection Agency (EPA) announced its decision to formally classify five known or suspected carcinogens as High-Priority Substances (HPS) for risk evaluation under the Toxic Substances Control Act (TSCA). Additionally, the Agency revealed the launch of a 9- to 12-month statutory process to prioritize another set of five chemicals under TSCA, aiming to determine whether they should also undergo risk evaluations.

EPA Begins Risk Evaluations for Five Chemicals

In July 2024, EPA proposed 5 chemicals for risk evaluation, releasing significantly more data earlier than previous efforts, providing the public better opportunities for input. This streamlined approach builds on improvements made over the past year, including advanced software for earlier data reviews, enhanced systematic review methods recommended by the Scientific Advisory Committee on Chemicals (SACC), and interactive tools to improve transparency.

EPA will now begin evaluating whether these substances pose unreasonable risks to health or the environment under their current uses. If risks are identified, the Agency will promptly initiate management measures to address them. The chemicals are:

• Vinyl chloride (CASRN 75-01-4), widely used in producing plastics such as PVC, plastic resins, and other materials for pipes, insulation, and consumer goods, poses significant health risks. Exposure can cause liver toxicity and is linked to cancer, as it is a known human carcinogen.
• Acetaldehyde (CASRN 75-07-0), widely used in manufacturing adhesives, petrochemicals, and intermediates for packaging and construction materials, poses health risks, including respiratory irritation. It is also a probable human carcinogen.
• Acrylonitrile (CASRN 107-13-1), widely used in producing plastics, paints, petrochemicals, etc., poses health risks, including respiratory irritation and is classified as a probable human carcinogen.
• Benzenamine (CASRN 62-53-3), widely used in manufacturing dyes, pigments, plastics, and chemicals, poses potential health risks including blood disorders, reproductive harm, and fetal development issues. It is also classified as a probable human carcinogen.
• 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4), widely used in manufacturing rubbers, plastics, and resins, is classified as a probable human carcinogen. Studies show it can damage genetic material in cells, posing significant health risks, especially to infants and children.

Prioritization Process Initiated for the Next Five Chemicals:

• Benzene (CASRN 71-43-2): Used in manufacturing adhesives, petrochemicals, plastics, and consumer products such as paints and fuels. Benzene is a known human carcinogen linked to leukemia and immune system impacts.
• Ethylbenzene (CASRN 100-41-4): Found in petroleum, paints, adhesives, and plastics. Exposure may harm the liver, kidneys, and hearing and is a probable carcinogen linked to lung and kidney tumors in animals.
• Naphthalene (CASRN 91-20-3): Used in paints, fuels, and metal products. It may cause red blood cell damage, liver and lung tissue harm, and is a probable carcinogen linked to lung and nasal tumors.
• Styrene (CASRN 100-42-5): Found in adhesives, plastics, toys, and construction materials. Styrene may lead to hearing loss, memory issues, miscarriages, and tissue damage. It is a probable carcinogen linked to lung tumors in animals.
• 4-tert-Octylphenol (CASRN 140-66-9): Used in plastics and automotive products. Exposure may cause kidney inflammation and reduced sperm count, potentially affecting fertility.

EPA has opened a 90-day public comment period, seeking information on the uses, hazards, exposures, and potential risks of the five chemicals under review. Comments are due by March 18, 2025.