USA Regulatory News

On July 22, 2024, Alaska enacted Senate Bill (SB) 67, which phases out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS). The bill automatically became law after the ...

On July 22, 2024, Alaska enacted Senate Bill (SB) 67, which phases out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS). The bill automatically became law after the Governor neither signed nor vetoed it within the designated 22-day period.

Introduction:

Aqueous Film Forming Foam (AFFF), a firefighting foam used primarily on military bases and airports to fight fuel and chemical fires, contains per- and polyfluoroalkyl substances (PFAS). PFAS are a group of over 12,000 chemicals widely used in consumer products, industrial applications, and industrial firefighting foams. Even minimal exposure to PFAS has been associated with severe health issues, including liver and kidney damage, reproductive and developmental harm, immune system impairment, and certain cancers.

Proposed Bill:

The majority of PFAS contamination in Alaskans' drinking water is linked to the dispersive use of PFAS-based industrial firefighting foams at airports and military bases. Starting January 1, 2025, a ban on AFFF and a disposal program will be implemented. The new legislation mandates a transition to PFAS-free foams and authorizes the removal of PFAS firefighting foams from villages with populations of less than 2,000.

Rather than having the state directly handle the collection and disposal of PFAS in rural villages, the state will reimburse these communities for the associated costs. This includes expenses related to replacing equipment potentially contaminated by PFAS foams. However, these foams may still be used if required by federal law, according to the bill.

Exemptions:

Oil and gas facilities, which are at risk of especially intense fires will be permitted to use existing foams until the state fire marshal officially identifies an alternative firefighting foam that is both PFAS-free and proven to be safe and effective. Once that determination is made, the state fire marshal is expected to enact a regulation mandating these facilities to switch to PFAS-free foams, as required by the bill.

On July 16, 2024, the US Environmental Protection Agency (EPA) finalized the Integrated Risk Information System (IRIS) Toxicological Review for perfluorodecanoic acid (PFDA) and related salts. The Age...

On July 16, 2024, the US Environmental Protection Agency (EPA) finalized the Integrated Risk Information System (IRIS) Toxicological Review for perfluorodecanoic acid (PFDA) and related salts. The Agency has raised the acceptable reference dose (RfD) for PFDA. The final review tripled the proposed risk threshold for PFDA, indicating that any subsequent risk management measures will be less stringent.

Introduction:

Perfluorodecanoic acid (PFDA, CASRN 335-76-2) and its related salts, members of the per- and polyfluoroalkyl substances (PFAS) group, are known for their resistance to hydrolysis, photolysis, and biodegradation, resulting in persistent environmental contamination. EPA's Integrated Risk Information System (IRIS) review covers PFDA and its fully dissociating salts, such as ammonium perfluorodecanoate (CASRN 3108-42-7), and sodium perfluorodecanoate (CASRN 3830-45-3) which are expected to fully dissociate in aqueous solutions at pH ranging from 4 to 9 (e.g., in the human body).

Human studies indicate that PFDA exposure may cause liver, immune, developmental, and reproductive effects, with potential impacts on cardiometabolic and neurodevelopmental health. The IRIS program is developing a series of five PFAS assessments at the request of EPA to address these concerns.

Final Report:

The reference dose (RfD) for PFDA remains significantly lower than the RfDs for PFBA and PFHxA, which were finalized in last year's IRIS assessments. It is also comparable to the preliminary RfDs for PFHxS and PFNA, which are currently in the draft assessment stage. The final PFDA assessment used the same studies, hazard endpoints, points of departure (PODs) and uncertainty factors as the draft assessment to determine the overall RfD.

Organ-specific RfDs for health effects compared with the 2023 draft review of PFDA:

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a compliance guide for the recently enacted methylene chloride risk management rule under the Toxic Substances Control Act (TSCA...

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a compliance guide for the recently enacted methylene chloride risk management rule under the Toxic Substances Control Act (TSCA). The guide is intended to assist industry, workers, and stakeholders to comply with the regulations designed to prevent injuries, illnesses, and deaths.

In April 2024, EPA finalized a ban on most uses of methylene chloride, citing its links to various cancers, neurotoxicity, and other severe health risks. The regulation, effective from July 8, 2024, aims to protect public health while allowing essential uses to continue safely under a robust Workplace Chemical Protection Program (WCPP).

Affected Stakeholders

The methylene chloride rule affects anyone involved in the manufacturing, importing, processing, distributing, using, or disposing of methylene chloride or products containing it. This includes the use of methylene chloride in laboratories.

Workplace Chemical Protection Program

A Workplace Chemical Protection Program (WCPP) is required in order to continue 13 conditions of use of methylene chloride. These uses include:

1. Domestic manufacturing

2. Import

3. Processing as a reactant

4. Processing in incorporation into formulation, mixture, or reaction product

5. Processing in repackaging

6. Processing in recycling

7. Use as a laboratory chemical.

8. Use in paint and coating removers for safety-critical, corrosion-sensitive components of aircraft and spacecraft

9. Use as a bonding agent for solvent welding

10. Industrial and commercial use as a processing aid

11. Use in the manufacture of plastic and rubber products

12. Use as a solvent that becomes part of a formulation or mixture where the formulation or mixture will be used inside a manufacturing process and the solvent (methylene chloride) will be reclaimed

13. Disposal

The WCPP requires owners and operators of facilities using methylene chloride to comply with new inhalation exposure limits, including a maximum of 2 ppm over an 8-hour period, and must create and enforce an exposure control plan.

Key Phase-Out and Information Deadlines:

• May 5, 2025: Prohibition on distributing methylene chloride for consumer use.
• April 28, 2026: Prohibition on most commercial uses.
• October 7, 2024: Deadline for manufacturers to update Safety Data Sheets (SDS) to spread awareness throughout the supply chain.
• December 4, 2024: Deadline for processors and distributors to update SDSs.

The compliance guide includes special attention to the interests and needs of small businesses. More information on the implemented regulation can be accessed here.

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.