USA Regulatory News

The Environmental Protection Agency (EPA) has announced the release of a significantly improved Pesticide in Water Calculator. This updated tool makes it easier to estimate pesticide concentrations in...

The Environmental Protection Agency (EPA) has announced the release of a significantly improved Pesticide in Water Calculator. This updated tool makes it easier to estimate pesticide concentrations in water bodies, which helps with risk evaluations for both ecological and human health.

Key Improvements: Faster, Easier and More Comprehensive

Faster processing rates and an intuitive interface of the new calculator enable faster and more effective analysis. One important feature is the ability to conduct multiple pesticide simulations at the same time, which eliminates a laborious manual process that was previously required.

Automated Features Enhance Accuracy

The updated calculator integrates a number of previously distinct processes into one smooth operation. It no longer requires extra models since it now automatically computes parameters like pesticide spray drift. In addition, users may automatically include all pertinent water bodies in risk evaluations and take into consideration how the weather affects the application of pesticides.

Promoting Transparency and Collaboration

The purpose of making this calculator available to the public is to increase the transparency of EPA's risk assessment procedures. This tool can be used by stakeholders to provide input on submissions to the Agency, encouraging collaboration and informed decision-making.

This update follows a previous update from April 2023, which standardised scenarios for evaluations of ecological and drinking water risks. To ensure the efficacy of the model, EPA will continue to update it as needed.

*Source

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) released finalized test methods for measuring disinfectant residues on hard surfaces treated with quaternary ammonium and phenolic comp...

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) released finalized test methods for measuring disinfectant residues on hard surfaces treated with quaternary ammonium and phenolic compounds after rinsing with water. These protocols aim to standardize the procedure for evaluating disinfectant residue levels after a potable water rinse (PWR).

Many disinfectant product labels mandate a water rinse after use to remove potentially harmful chemical residues. The primary objectives of these protocols are to quantitatively apply disinfectants, determine post-application residue levels and establish a standardized method for analysis. This is critical to ensuring the safety and efficacy of disinfectants used in a variety of environments, particularly those involving food preparation.

Introduction:

Quaternary ammonium compounds, found in many disinfectant sprays and wipes, kill bacteria, viruses, and mold. Phenolic compounds, used in household and consumer products, also kill bacteria and disinfect surfaces. These two chemical classes represent the range of disinfectant residues that could remain after a potable water rinse (PWR), with quaternary ammonium compounds expected to leave the most residues and phenolic compounds the least. The finalized test methods developed for these compounds can be adapted for other disinfectant chemicals that require a PWR.

Phenolic Compounds Protocol

1. Representative Surfaces and Disinfectants:
   • Surfaces: Stainless steel, laminate (e.g., Formica), granite, and ceramic tile.
   • Disinfectants: Various phenolic compounds, including phenol, 2-phenylphenol, 2-benzyl-4-chlorophenol, and 4-tert-amylphenol in forms such as trigger sprays, wipes, and aerosols.
2. Procedure:
   • Disinfectants are applied using a pipette to ensure a known amount is deposited on the test surface.
   • A TQC Scrub Abrasion and Washability Tester is used to perform standardized wiping with lint-free cotton cloths soaked in potable water.
   • Residues are then extracted with methanol and analyzed using high performance liquid chromatography (HPLC) with ultraviolet detection.

Quaternary Ammonium Compounds (QACs) Protocol

1. Representative Surfaces and Disinfectants:
   • Surfaces: Same as for phenolic compounds.
   • Disinfectants: QACs such as dialkyldimethylammonium salts and benzylalkylammonium dimethyl salts, in forms such as liquid trigger sprays, concentrates, wipes, and aerosol sprays.
2. Procedure:
   • Similar to the protocol for phenolic compounds, disinfectants are applied using a pipette.
   • The same TQC tester is used for wiping.
   • Residues are analyzed by liquid chromatography tandem mass spectrometry (LC/MSMS).

Key findings

The tests show that residue levels of phenolic compounds and quaternary ammonium compounds (QACs) vary based on the surface type and disinfectant formulation, with stainless steel surfaces generally retaining the least residue after a potable water rinse (PWR). The efficiency of residue removal was consistent across different wiping materials for both compound types, with lint-free cotton cloths being the most effective.

The use of mechanical wiping devices and precise application techniques minimizes human error and variability, increasing the robustness of these protocols for regulatory and safety assessments.

EPA’s finalized guidance for analyzing disinfectant residues on hard, non-porous surfaces after rinsing is available on Regulations.gov.

On June 5, the U.S. Environmental Protection Agency (EPA) announced a proposed rule under the Toxic Substances Control Act (TSCA) to protect workers and consumers from exposure to the solvent n-methyl...

On June 5, the U.S. Environmental Protection Agency (EPA) announced a proposed rule under the Toxic Substances Control Act (TSCA) to protect workers and consumers from exposure to the solvent n-methylpyrrolidone (NMP). This proposal is the sixth chemical to be reviewed for the 'first ten' chemicals under the amended TSCA, following actions on asbestos, methylene chloride, trichloroethylene, perchloroethylene, and carbon tetrachloride.

EPA's 2020 risk evaluation found that NMP poses an unreasonable risk to health, with exposure associated with significant adverse effects, including miscarriage, reduced fertility, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin irritation, and sensitization.

If finalized, the rule would limit NMP concentrations in certain consumer and commercial products, establish strict workplace health controls, and ban some uses where safer alternatives exist.

NMP in Industrial and consumer products

NMP is used in solvent cleaning and surface treatment of metals, textiles, resins, and plastics. In the commercial sector, it is used in the manufacture and removal of paints, coatings and adhesives. Common consumer uses include paints, coatings, glues, adhesive removers, lubricants, and automotive care products.

Proposed rule:

EPA is proposing, under TSCA section 6(a), to:

(i) Ban the manufacture, processing, distribution, and use of NMP for five of 37 evaluated occupational conditions of use (CoU). It also establishes a de minimis threshold of 0.1% by weight below which products would be exempt from the provisions of the rule.

(ii) Establish container size limits and labeling requirements for the manufacture (including import), processing, and distribution in commerce of NMP for seven consumer uses.

The following NMP-containing products cannot be sold in containers larger than 16 ounces and must be labeled 'for consumer use only':

• Paint and coating removers
• Adhesive removers
• Paints and coatings (lacquers, stains, varnishes, primers, floor finishes)
• Paint and coating additives
• Automotive care products
• Cleaning and furniture care products
• Lubricants and lubricant additives

(iii) Require prescriptive controls, including concentration limits and personal protective equipment (PPE), for seven occupational conditions of use. These requirements would be phased in over a two-year period.

(iv) Strict workplace controls, including NMP Workplace Chemical Protection Programs (WCPPs), would be mandated for all other occupational conditions of use.

This includes commercial use of high NMP concentration products essential to the missions of the Department of Defense (DOD) and the National Aeronautics and Space Administration (NASA). These programs are designed to prevent direct dermal contact with NMP.

They would cover approximately 44% of the annual production volume of NMP, including manufacturing, processing, industrial, commercial uses, and disposal. Businesses would have 12 months to establish a WCPP, while federal agencies would have three years to comply.

(v) Require a concentration limit on NMP for the import, processing, and distribution in commerce for a consumer use

(vi) Establish recordkeeping and downstream notification requirements

EPA will accept public comments on the proposed rule for NMP for 45 days following publication in the Federal Register via docket EPA-HQ-OPPT-2020-0744.

On May 22, 2024, the Washington Department of Ecology initiated rulemaking to ban a number of chemicals in personal care products under Chapter 173-339 WAC which imposes restrictions on nine toxic ch...

On May 22, 2024, the Washington Department of Ecology initiated rulemaking to ban a number of chemicals in personal care products under Chapter 173-339 WAC which imposes restrictions on nine toxic chemicals or chemical classes in cosmetic products from January 1, 2025. The Agency is also considering regulations on formaldehyde-releasing chemicals, with potential restrictions beginning in 2026.

Background:

In 2023, the Washington Legislature passed the Toxic-Free Cosmetics Act (TFCA) to improve the safety of cosmetic and personal care products. The TFCA addresses the health risks posed by harmful chemicals in cosmetics, that are linked to cancer, hormone disruption, and reproductive toxicity. These chemicals also impact the environment and public health throughout their lifecycle, from being washed down the drain to entering the ecosystem as waste.

The TFCA restricts the manufacture, distribution, and sale of cosmetics containing certain toxic chemicals in Washington State. It mandates the evaluation of safer alternatives, provides technical support to small businesses in the cosmetics industry, and identifies and restricts chemicals that release formaldehyde.

Chemicals restricted under the TFCA:

Effective January 1, 2025, the TFCA imposes restrictions on nine toxic chemicals and classes of chemicals present in cosmetic products manufactured, distributed, or sold in Washington. For in-state retailers, restrictions on existing stock take effect on January 1, 2026.

TFCA compliance extends to all entities involved in the production, distribution, sale, or provision of cosmetic products in Washington, including cosmetic manufacturers, brands, distributors, retailers, cosmetologists, and cosmetology establishments such as hair and nail salons.

Formaldehyde restrictions

The TFCA is considering a rulemaking process to establish restrictions on formaldehyde-releasing chemicals. As per the legislation, the earliest these restrictions could come into force are:

• January 1, 2026, for up to 10 chemicals in cosmetics that release formaldehyde.
• January 1, 2027, for additional formaldehyde-releasing chemicals used in cosmetics.

Currently, the Washington Department of Ecology is actively identifying and regulating the use of formaldehyde-releasing chemicals.

These chemicals, which are used as preservatives in cosmetic products such as shampoos, lotions, makeup, and hair treatments, gradually release formaldehyde. Known as "formaldehyde releasers," they pose significant health risks, including cancer, neurological harm, asthma aggravation, eye and skin irritation, and allergic reactions. These cosmetics can release formaldehyde into both indoor and outdoor environments, which can then enter the wastewater systems through drainage.

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 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.

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.