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:

Maine law 32 MRS §1733(3-B) requires the Department of Environmental Protection to initiate rulemaking to ban PFAS in food packaging as soon as safer alternatives are available. On April 18, 2024, th...

Maine law 32 MRS §1733(3-B) requires the Department of Environmental Protection to initiate rulemaking to ban PFAS in food packaging as soon as safer alternatives are available. On April 18, 2024, the Board of Environmental Protection approved Chapter 80 Section 5, which bans per- and polyfluoroalkyl substances (PFAS) in specific food packaging sold in Maine. This prohibition will become effective May 25, 2026, two years after the rule's official adoption by the Secretary of State. 

This new rule is the first major update to Maine's 1992 regulations to reduce toxics in packaging. The ban is based on a 2019 state law that has been delayed due to concerns about the cost and availability of non-PFAS alternatives. 

Types of Food Packaging Affected: 

Bags and Sleeves: Flexible, foldable containers for transporting food, including bags with sealed ends such as pinch-bottom bags. 

Bowls: Open-topped, wide-rimmed containers designed for serving foods with significant liquid content, including portion cups. 

Closed Containers: Fully enclosed containers with interlocking or overlapping walls for secure transport. Examples: clamshells, food pails, bakery boxes, deli containers. 

Flat Service ware: Shallow, flat-bottomed containers with large surface areas or compartments for serving and transporting food. Examples: trays, cafeteria trays, plates. 

Food Boats: Tray-like containers with high sides and no compartments. 

Open-Top Containers: Containers that enclose food on all but one side and are used for serving or transporting food. Examples: paper cones, cups, bowls, food boats. 

Pizza Boxes: Folded boxes for holding and transporting various sizes of pizza or calzones. 

Plates: Flat service ware, either single-piece or with compartments, used for serving or holding food. 

Wraps and Liners: Sheets used to wrap food or line other service ware to provide an additional barrier. 

Exemptions 

The prohibition does not apply to manufacturers with annual national food and beverage sales of less than $1 billion. This applies to any manufacturer of a food or beverage product that comes in a food package or to which a food package is applied. 

Chemicals of High Concern List 

The new regulations (32 MRSA, Chapter 26-B) require the Department to create and publish a list of up to 10 "Chemicals of High Concern" associated with food contact materials. This list will help track the use of these chemicals in food packaging. To qualify, a substance must meet these criteria: 

• Listing: Included on the Maine Chemicals of Concern list (Title 38, section 1693); or  

• Governmental Recognition: Recognized by an authoritative entity as: 

  •  A carcinogen, or a reproductive/developmental toxicant, or an endocrine disruptor; 

  • Persistent, bioaccumulative, and toxic (PBT); or 

  • Very persistent and very bio accumulative (vPvB). 

• Scientific Evidence: Credible scientific evidence that the chemical is a reproductive or developmental toxicant, endocrine disruptor or human carcinogen.  

• Exposure criteria: The chemical must also meet at least one of these criteria based on strong scientific evidence: 

  • Detected in human blood, breast milk, urine, or other body tissues or fluids. 

  • Found in food or beverage products through analysis.  

  • Added to or present in a food package. 

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 13, 2024, the U.S. Environmental Protection Agency (EPA) announced that its Science Advisory Committee on Chemicals (SACC) will conduct a peer review of two key assessments: the Draft Risk Eva...

On June 13, 2024, the U.S. Environmental Protection Agency (EPA) announced that its Science Advisory Committee on Chemicals (SACC) will conduct a peer review of two key assessments: the Draft Risk Evaluation for 1,1-dichloroethane and the draft hazard assessment supporting the Draft Risk Evaluation for 1,2-dichloroethane (commonly referred to as ethylene dichloride). Additionally, EPA is seeking public comments on potential candidates for ad hoc reviewer roles to support the SACC in this review process. 

Comprehensive Review of Industrial Solvent Risk Assessment Documents under TSCA 
 
EPA is conducting risk evaluations for two solvents, 1,1-dichloroethane and 1,2-dichloroethane, under the Toxic Substances Control Act (TSCA). 1,1-dichloroethane is used in industrial settings, mainly for chemical production and laboratory work, with no consumer applications. In contrast, 1,2-dichloroethane is primarily used in the production of vinyl chloride. 

EPA originally planned to gather feedback on the draft risk evaluation for 1,1-dichloroethane through a letter peer review but has now opted for a more thorough review by convening the SACC. 

EPA is also seeking input on the draft hazard assessment for 1,2-dichloroethane, which provides crucial toxicity data to help understand the toxicity of 1,1-dichloroethane due to their structural similarities. This assessment will inform the upcoming draft risk evaluation for 1,2-dichloroethane that EPA will release for public comment and peer review in the future. 

The SACC will conduct its peer review in a public meeting, preceded by a virtual session to discuss draft charge issues and review scope. Registration details for these meetings will be posted on EPA’s peer review website in the coming months. 

Public Comments on Ad Hoc Peer Reviewers 

EPA is seeking public input on potential candidates to serve as ad hoc peer reviewers for the risk evaluations of 1,1-dichloroethane and 1,2-dichloroethane. Following a previous call for nominations in March 2024, no new nominations will be accepted. EPA will proceed with the previously identified candidates for the SACC review, which will replace the originally planned letter peer review. 

Biographies of these candidates can be accessed in docket EPA-HQ-OPPT-2024-0114  and on EPA’s peer review website. Public comments on the candidates must be submitted to www.regulations.gov by June 28, 2024. Commenters should avoid including confidential business information or sensitive personal data, as this information may be publicly posted online. 

During the selection process, candidates will be required to submit confidential financial disclosures detailing their employment, investments, and research funding sources. These disclosures will be reviewed by EPA to ensure that there are no conflicts of interest, biases, or prior involvement with the documents under review. 

Feedback from the SACC will be crucial in guiding EPA's final risk evaluations and influencing its risk management decisions under TSCA.