USA Regulatory News

On May 16, 2024, following an announcement in January 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule to update the chemicals listed in the Toxics Release Inventory (TRI) to i...

On May 16, 2024, following an announcement in January 2024, the U.S. Environmental Protection Agency (EPA) issued a final rule to update the chemicals listed in the Toxics Release Inventory (TRI) to include seven new per- and polyfluoroalkyl substances (PFAS) for the 2024 reporting year. 

Background on the Toxics Release Inventory 

The Environmental Protection Agency (EPA) collects annual data on TRI-listed chemicals from facilities in designated industries and federal facilities that manufacture, process, or use these chemicals above certain thresholds. This data helps communities understand how these facilities handle these chemicals; facilitates informed decision-making for companies, government agencies, and the public; and aligns with the Administration's commitment to environmental justice by increasing accountability, transparency, and the well-being of families, workers, and communities. The data collected is easily accessible online. 

Mandate for PFAS Inclusion 

The Fiscal Year 2020 National Defense Authorization Act (NDAA) mandated the inclusion of seven PFAS into the Toxics Release Inventory (TRI). The latest rule includes reporting guidelines for these seven PFAS in the Code of Federal Regulations, increasing the total count of PFAS under TRI reporting to 196. The seven newly added PFAS, along with the previous 189 PFAS listed in the TRI, are affected by EPA’s decision in October 2023 to classify all PFAS under TRI reporting as chemicals of special concern. This designation eliminates the reporting exemption that previously allowed facilities to avoid reporting information on PFAS when used in small concentrations. This move demonstrates EPA's commitment to mitigating the effects of persistent chemicals and is consistent with its PFAS Strategic Roadmap, which aims to address the serious risks these chemicals pose to both human health and the environment. 

Addition of PFAS with final toxicity values 

The 2020 NDAA contains a provision requiring the automatic inclusion of PFAS to TRI once the Agency establishes a toxicity value. Six PFAS were added to the list for the 2024 Reporting Year after EPA finalized a toxicity value in 2023. Only the specified salt forms of the acids are included in this list. 

• Ammonium perfluorohexanoate; Chemical Abstracts Service Registration Number (CASRN) 21615-47-4 

• Lithium bis[(trifluoromethyl)sulfonyl] azanide; CASRN 90076-65-6 

• Perfluorohexanoic acid (PFHxA); CASRN 307-24-4 

• Perfluoropropanoic acid (PFPrA); CASRN 422-64-0 

• Sodium perfluorohexanoate; CASRN 2923-26-4 

• 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CASRN 82113-65-3 

Removal of Confidentiality Claims 

EPA is no longer treating PFAS as confidential business information (CBI) under NDAA section 7321(e). EPA must assess CBI claims before incorporating a PFAS chemical in the Toxic Release Inventory (TRI). Betaines, dimethyl(γ-ω-perfluoro-γ-hydro-C8-18-alkyl); CASRN 2816091-53-7, was previously identified for inclusion but was not included due to CBI claims. In February 2023, the identity of the chemical was declassified and is no longer confidential. As a result, it has now been added to the TRI. 

Reporting Deadline and Compliance 

Starting January 1, 2024, facilities must report on the seven PFAS chemicals added to the TRI, under Section 313 of the Emergency Planning and Community Right-to-Know Act and submit reporting forms by July 1, 2025. 

On May 23, 2024, the U.S. Environmental Protection Agency (EPA) released the latest update to the Toxic Substances Control Act (TSCA) Inventory. This biannual update, which makes non-confidential TSCA...

On May 23, 2024, the U.S. Environmental Protection Agency (EPA) released the latest update to the Toxic Substances Control Act (TSCA) Inventory. This biannual update, which makes non-confidential TSCA Inventory data publicly available, aligns with the 2024 Chemical Data Reporting (CDR) cycle, which starts on June 1, 2024. Manufacturers and importers should consult the updated TSCA Inventory to determine which chemicals they will be required to report under the CDR rule. The next scheduled update of the TSCA Inventory is anticipated in early 2025.

TSCA Inventory:

The TSCA Inventory is a list of all existing chemicals manufactured, processed or imported in the U.S. Section 8(b) of the Toxic Substances Control Act (TSCA) requires EPA to compile, maintain and publish a list of each chemical substance that is manufactured or processed in the United States, including imports, for uses under TSCA.

TSCA defines a “chemical substance” as any organic or inorganic substance having a particular molecular identity, including any combination of these substances occurring in whole or in part because of a chemical reaction or that occurs in nature, and any element or uncombined radical.

The chemicals listed in the TSCA Inventory include:

• Organics
• Inorganics
• Polymers
• Chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs).

Chemicals listed on the Inventory are referred to as "existing" in U.S. commerce, while those not listed are referred to as "new." The Inventory also indicates "flags" for those existing chemical substances that are subject to manufacturing or use restrictions. Confirming a chemical's Inventory status is crucial before initiating manufacturing or importing activities, because anyone planning to manufacture a new chemical for commercial use must submit a Premanufacture Notice (PMN) to EPA at least 90 days before commencing the activity.

Updates:

The TSCA Inventory now contains 86,770 chemicals of which 42,377 are active in U.S. commerce. Other updates include revisions to commercial activity data and regulatory flags such as Significant New Use Rules.

As part of EPA's ongoing review of confidential business information under TSCA, more substances are continually being listed with their unique chemical identities as they transition from the confidential segment of the TSCA Inventory to the public section. Since the last update of the TSCA Inventory in February 2024, EPA has transferred approximately 133 chemical identities from the confidential section to the public section.

On May 16, 2024, the California Department of Toxic Substances Control (DTSC) released the draft 2024-2026 Priority Product Work Plan detailing the items to be investigated under the Safer Consumer Pr...

On May 16, 2024, the California Department of Toxic Substances Control (DTSC) released the draft 2024-2026 Priority Product Work Plan detailing the items to be investigated under the Safer Consumer Products (SCP) program. This plan which focuses on paints and microplastics, continues to build on previous years’ assessments. The draft Work Plan is open for comment until July 1.

Introduction:

The California Department of Toxic Substances Control's (DTSC) Safer Consumer Products (SCP) Program is recognized worldwide for reducing hazardous chemicals in consumer goods. SCP identifies and regulates Chemicals of Concern from a list of Candidate Chemicals that are known to have one or more hazard traits, compelling manufacturers to seek safer alternatives or remove them from products, benefiting homes, workplaces, and ecosystems.

The Work Plan outlines seven consumer product categories to be evaluated between 2024 and 2026. Four categories are carried over, largely unchanged from the 2021-2023 plan:

• Beauty, Personal Care, and Hygiene Products
• Cleaning Products
• Building Products and Materials Used in Construction and Renovation
• Children’s Products

Two categories are carried over and expanded:

• Food Packaging (expanded to Food Contact Articles)
• Motor Vehicle Tires (expanded to Motor Vehicle Parts, Accessories, Maintenance, and Repair Materials)

And the Work Plan includes two new categories:

• Paints (carved out of the Building Products and Materials Used in Construction and Renovation category)
• Products that Contain or Generate Microplastics

Starting with the 2024-2026 edition, Work Plans must incorporate certain additional details, such as information DTSC has on the chemicals that may be of concern within each product category or subcategory, any additional ingredient information needed to evaluate the safety of consumer products, information on how DTSC plans to fill data gaps and timelines for collecting and finalizing the information.

Paints

The rationale for singling out paints in the current Work Plan stems from their widespread use and potential exposure to harmful chemicals, raising concerns about adverse impacts on various groups, including workers, children, and the environment. Chemicals found in paints, such as formaldehyde, acrylic acid, styrene, BPA, benzene, toluene, xylenes, and PFASs, are associated with serious health risks, including reproductive toxicity, developmental toxicity, neurotoxicity, endocrine disruption, respiratory toxicity, etc. Additionally, the release of microplastics and toxic chemicals from degraded paint coatings poses a threat to aquatic life and public health, requiring a thorough evaluation of these risks and mitigation strategies.

Products that Contain or Generate Microplastics

Microplastics fall into two main categories: primary microplastics, such as microbeads, that are intentionally added to products, and secondary microplastics that result from the breakdown of larger plastic items.

Consumer goods such as plastic packaging, synthetic textiles, and even paints can release microplastics during their lifecycle. Recognizing their ubiquitous, persistent, and mobile presence, and their potential harm to both humans and ecosystems, initial investigations into products that release microplastics has been launched, complementing the efforts to include them on DTSC’s Candidate Chemicals List.

Implementation Priorities and Considerations

For the 2024-2026 Work Plan, the Agency’s priorities include:

• Promoting environmental justice, with a focus on how Candidate Chemicals impact vulnerable communities near manufacturing sites.
• Protecting the health of children and workers from potential chemical exposures in consumer products.
• Minimizing releases of Candidate Chemical into indoor air and dust from consumer products.
• Reducing microplastic pollution throughout the lifecycle of consumer goods.
• Protecting California's water resources and aquatic ecosystems from chemical contamination.
• Collaborating with other state agencies to strengthen regulatory efforts.

The U.S. Environmental Protection Agency (EPA) is reminding companies of the upcoming 2024 Chemical Data Reporting (CDR) cycle, which begins June 1 2024 and ends September 30, 2024. This year, EPA h...

The U.S. Environmental Protection Agency (EPA) is reminding companies of the upcoming 2024 Chemical Data Reporting (CDR) cycle, which begins June 1 2024 and ends September 30, 2024. This year, EPA has launched a new resource portal and enhanced the reporting tool to streamline the chemical data reporting process.

Background:

The Chemical Data Reporting (CDR) rule mandates that manufacturers, including importers, report data to EPA every four years. This data includes information on the manufacture, processing, and use of chemicals unless exempted under the CDR rule. The reporting requirements apply to chemicals listed on the TSCA Chemical Substance Inventory if they are manufactured or imported above the regulatory threshold.

For the 2024 CDR, the primary reporting year is calendar year 2023. Manufacturers and importers must report comprehensive manufacturing, processing, and use data for calendar year 2023 only, and production volume data for calendar years 2020, 2021, 2022, and 2023.

The CDR database helps EPA and various stakeholders—including communities, regulatory agencies, industry, researchers, and NGOs—in understanding the types, quantities, and uses of chemicals produced domestically or imported into the U.S. This data helps EPA prioritize chemicals for evaluation of potential health and environmental impacts and ensures access to up-to-date chemical information.

Updates:

The CDR rule mandates that companies report data electronically using e-CDRweb via EPA's Central Data Exchange (CDX) system. The CDX tool has been updated to:

• Include the 2024 CDR reporting codes and corresponding reporting period years.
• Provide an updated spreadsheet for uploading bulk chemical information, available in the resources section of the reporting tool.
• Enhance functionality for copying Confidential Business Information claim substantiation between chemicals and for accessing and saving submitted records.

You must register with CDX and be approved by EPA before you can begin submitting forms.

The state of Colorado has updated its legislation regarding products with intentionally added PFAS, with phased implementation beginning in January 2025. On May 1, 2024, the Governor signed SB 24-081 ...

The state of Colorado has updated its legislation regarding products with intentionally added PFAS, with phased implementation beginning in January 2025. On May 1, 2024, the Governor signed SB 24-081 which makes significant revisions to the existing regulations. This amendment makes several key changes to the current regulatory framework. 

Previous PFAS Legislation 

In 2022 the State of Colorado passed legislation (the "Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act") to establish a regulatory scheme that prohibits the sale or distribution of certain products (i.e. carpets, fabric treatments, food packaging, oil/gas products) that contain intentionally added perfluoroalkyl and polyfluoroalkyl chemicals (PFAS chemicals). “Intentionally added PFAS chemicals” are defined as "PFAS chemicals that a manufacturer intentionally adds to a product and that have a functional or technical effect on the product” and also include any “intentional breakdown products” of added PFAS chemicals. 

New PFAS Legislation 

The new bill titled the “Perfluoroalkyl and Polyfluoroalkyl Chemicals Protection Act” includes the following restrictions on the use of intentionally added PFAS in consumer products:  

• January 1, 2025: The sale or distribution of certain outdoor apparel meant for prolonged or intensive use in extremely wet conditions (outdoor apparel for extremely wet condition) that contains intentionally added PFAS chemicals will be prohibited unless the product is accompanied by a disclosure stating that it contains PFAS chemicals (disclosure requirement). 

• January 1, 2026:  The sale and distribution of cleaning products, cookware, dental floss, menstrual products and ski wax that contain intentionally added PFAS chemicals will be prohibited as part of the product phaseout timeline. However, floor maintenance products used in hospitals or medical settings are exempted until January 1, 2028. 

• July 1, 2026: It will be illegal for anyone to install artificial turf containing intentionally added PFAS chemicals on any part of property in the state. 

• January 1, 2028: The disclosure requirement will be repealed, and the sale or distribution of outdoor apparel intended for extreme wet condition that contains intentionally added PFAS chemicals will be prohibited. In addition, the sale and distribution of textile articles and food contact equipment intended primarily for use in commercial settings that contain intentionally added PFAS will also be prohibited. 

• January 1, 2032: The product phaseout timeline will be repealed and the sale or distribution of any non-exempted product containing intentionally added PFAS chemicals will be prohibited.  

The full text of SB 24-081 can be found here. 

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has announced a final rule to update the Hazard Communication Standard (HCS). This update aligns the HCS primarily...

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has announced a final rule to update the Hazard Communication Standard (HCS). This update aligns the HCS primarily with the seventh revised edit of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS 7). Published on May 20, 2024, the rule will take effect on July 19, 2024.

This final rule aims to address issues that have arisen since the implementation of the 2012 standard, as well as improve alignment with other federal agencies and Canada.

History:

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been adopted worldwide to standardize the handling and labeling of hazardous chemicals. In 2012, the Occupational Safety and Health Administration (OSHA) revised its Hazard Communication Standard (HCS), 29 CFR 1910.1200, to align with the third revision of the GHS (GHS 3) (77 FR 17574). The GHS is updated every two years to incorporate improvements and clarifications. Since OSHA adopted GHS 3, there have been seven updates, the most recent being Revision 10, published in 2023. The current rulemaking primarily aligns the HCS with GHS 7, which waspublished in 2017.

Established in 1983, the HCS aims to standardize the communication of workplace hazards associated with hazardous chemicals. It mandates chemical manufacturers and importers to classify the hazards of the chemicals they produce or import. The latest amendments do not alter the basic structure of the HCS.

OSHA has determined that these updates will improve the effectiveness of the HCS, ensuring that employees are better informed about the chemical hazards they may encounter. This, in turn, is expected to reduce the incidence of chemical-related occupational illnesses and injuries. The revisions include updated criteria for classifying certain health and physical hazards, new provisions for updating labels and labeling small containers, changes related to trade secrets, technical amendments concerning the contents of safety data sheets (SDSs), and updates to definitions used in the standard.

Major changes to the Hazard Communication Standard:

• Hazard Classification: Provides specific criteria for classifying health and physical hazards and classifying of mixtures.

• Labeling: Chemical manufacturers and importers must now include a harmonized signal word, pictogram and hazard statement for each hazard class and category on their labels. Precautionary statements are also mandatory. Additionally, labels on shipped containers must display the date the chemical is released for shipment. There are new, detailed labeling requirements for small containers, specifically those with a capacity of 100 ml or less.

• Safety Data Sheets: The format for Safety Data Sheets (SDS) is now standardized to a specified 16-section layout.

• Information and Training: Employers are required to train their workers on the new label elements andupdated Safety Data Sheets format to facilitate recognition and understanding.

• Trade Secrets: When claiming a specific concentration of a substance as a trade secret, prescribed concentration ranges must now be used, adding a layer of transparency and safety.

Manufacturers, importers and distributors must comply with the new requirements by January 19, 2026, for substances and by July 19, 2027, for mixtures. Employers have until July 20, 2026, for substances and January 19, 2028, for mixtures tocomply with the new standards.

Please see the Federal Register Notice for more information.

On May 10, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend Title 27, Section 25705(c)(2) of the California Code of Regulations to establish a Propositio...

On May 10, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend Title 27, Section 25705(c)(2) of the California Code of Regulations to establish a Proposition 65 No Significant Risk Level (NSRL) for titanium dioxide (airborne, unbound respirable particles). The proposal is open for public comment until June 24, 2024, and comments may be submitted electronically through OEHHA’s website (https://oehha.ca.gov/comments).

Background:

The Safe Drinking Water and Toxic Enforcement Act of 1986, known as “Proposition 65,” mandates that businesses provide clear warnings before knowingly exposing individuals to chemicals identified as carcinogens or toxic to reproduction. It also prohibits the discharge of these chemicals into water sources or onto land where they may contaminate drinking water.

The Office of Environmental Health Hazard Assessment (OEHHA) oversees the implementation of Proposition 65 and may adopt regulations to further its goals. Safe harbor levels, which include No Significant Risk Levels (NSRLs) for carcinogens and Maximum Allowable Dose Levels (MADLs) for reproductive toxicants, have been established for many listed chemicals. Exposures and discharges below these levels are exempt from the requirements of Proposition 65.

The proposed NSRL for titanium dioxide specifies that no warning is needed if the average daily exposure is at or below the following levels:

• For airborne, unbound particles with diameters of 10 micrometers (µm) or less, the proposed NSRL is 440 micrograms (µg); and
• For airborne, unbound particles with diameters of 0.8 µm or less, the proposed NSRL is 44 µg.

Other forms of titanium dioxide, such as non-airborne particles or those bound within a product matrix (e.g., rubber, ink, or paint), are not on the Proposition 65 list and thus do not require a warning.

History:

OEHHA maintains the Proposition 65 list of carcinogens and reproductive toxicants, including chemicals identified as human or animal carcinogens by the International Agency for Research on Cancer (IARC). A chemical is listed if IARC has classified it as carcinogenic to humans or possibly carcinogenic with sufficient evidence of carcinogenicity in animals.

IARC has classified titanium dioxide (TiO2) as a Group 2B carcinogen, which means that it is "possibly carcinogenic to humans." Consequently, OEHHA listed titanium dioxide (airborne, unbound particles of respirable size) as a carcinogen on September 2, 2011. The National Institute for Occupational Safety and Health (NIOSH) also determined in 2011 that ultrafine TiO2 is a potential occupational carcinogen.

Anticipated Benefits of the Proposed Regulation:

Regulated businesses using the NSRL will find it easier to determine if their products' exposure to titanium dioxide (airborne, unbound particles of respirable size) poses no significant cancer risk. This simplifies compliance, reduces over-warning, and supports the statute's goal of promoting the health and safety of Californians. Additionally, while the NSRL doesn't mandate reduced exposures, it may encourage businesses to reduce exposures to non-significant risk levels, thereby benefiting public health.