USA Regulatory News

On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new subst...

On February 8, 2024, the Environmental Protection Agency (EPA) finalized amendments to the 2018 Toxic Substances Control Act (TSCA) Fees Rule, which will increase fees and double the cost of new substance applications. The final rule aims to recover more program costs through industry-submitted fees. The agency cites the need for funding due to expanded TSCA responsibilities. Increased fees will increase resources for efficient chemicals, allowing for better protection of communities and supporting American innovation.

The final rule will become effective 60 days after its official publication in the Federal Register.

Key Changes

The final rule sets a fee of $37,000 for filing a Pre-Manufacture Notice (PMN) or Significant New Use Notice (SNUN), and $10,870 for filing a new chemicals exemption notice under TSCA Section 5. The EPA-initiated risk evaluation fee will increase from $1.605 million to $4.287 million which will be shared among responsible companies. Meanwhile, test orders will be priced at $25,000. Small businesses are eligible for an 80% fee reduction in each category. Some fees were reduced from the 2022 supplemental proposal due to adjustments in program costs.

Comparison to Previous Proposals 

• The final rule excludes extra fee categories proposed in 2021, such as filing a bona fide notice or Notice of Commencement (NOC) for new substance manufacturing.
• EPA maintains its approach of allocating risk evaluation fees based on production volume, with top producers covering 80% of the total fee.
• Despite suggestions for a REACH-like tonnage band system, the agency rejected it due to potential difficulties in estimating future manufacturers, resulting in a 25% program cost gap.
• EPA dismissed addressing the issue of 'free riders' entering the market after invoicing, acknowledging a competitive disadvantage for companies that already submitted fees. The agency plans to monitor this issue for potential inclusion in future TSCA fee rules.
• However, EPA is backing away from refunding fees to PMN submitters who withdraw before risk management, citing resource constraints and staff burden.

Exemptions

The new rule adds exemptions not included in the 2018 fee rules: 

(1) An exemption for research and development activities 

(2) An exemption for companies that manufacture less than 2,500 pounds (lbs) of a chemical subject to an EPA-initiated risk evaluation, or 1,100 lbs for TSCA Section 4 test rules.

(3) An exemption for manufacturers of chemical substances produced as non-isolated intermediates.

(4) Exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, manufactured as a by-product, or manufactured or imported as an impurity.

Companies that fall into the first three categories must certify to the agency that they meet the exemption criteria. 

On February 5, 2024, the U.S. Environmental Protection Agency (EPA) reinstated all chlorpyrifos tolerances, overturning a previous rule that had halted its use on all food and feed commodities in earl...

On February 5, 2024, the U.S. Environmental Protection Agency (EPA) reinstated all chlorpyrifos tolerances, overturning a previous rule that had halted its use on all food and feed commodities in early 2022.

Additionally, EPA announced in a posting on its website its intent to revoke all but specific uses of chlorpyrifos: alfalfa, apple, asparagus, cherry (tart), citrus, cotton, peach, soybean, strawberry, sugar beet, wheat (spring), and wheat (winter). 

Affected Parties and Industries

The reinstatement of chlorpyrifos tolerances will primarily affect agricultural producers, food manufacturers, pesticide manufacturers, and others who use these products.

Recommended Actions

Stakeholders are advised to closely monitor developments and be prepared to adjust chlorpyrifos manufacturing, distribution, and growing practices, given the anticipated fluctuations in the regulatory landscape. Distributors and growers should check the current Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and state registration status of existing chlorpyrifos stocks before selling, distributing, or using them.

Although all chlorpyrifos tolerances were in effect at the time, EPA confirmed that growers could use registered chlorpyrifos products on relevant crops, adhering to labeled instructions. However, numerous registered chlorpyrifos products were canceled in 2022, with no provisions for continued use on food or feed crops. EPA emphasized that existing final cancellation orders for chlorpyrifos products, including terms for sale, distribution, and use, remained in place until further notice.

Background on Chlorpyrifos

Chlorpyrifos is a widely used organophosphate insecticide, acaricide and miticide used primarily to control foliage and soil-borne insect pests. In August 2021, in response to a court order EPA revoked all tolerances for chlorpyrifos residues, impacting various crops. This decision followed the Ninth Circuit Court's directive to either revoke or modify the tolerances within a limited timeframe. Consequently, as of February 28, 2022, any residues from chlorpyrifos applications after that date would render food adulterated. However, on November 2, 2023, the Eighth Circuit Court overturned EPA's revocation, citing insufficient consideration for certain crop uses identified for potential modification in 2020.

Next Steps

Many chlorpyrifos product registrations were revoked in 2022, and existing revocation orders remain in place unless amended by EPA. EPA plans to promptly propose a new rule to revoke tolerances for most uses, with additional restrictions to address safety concerns and protect sensitive populations and species. This proposal will be subject to a 60-day public comment period before being finalized, as required by the Federal Food, Drug, and Cosmetic Act.

Conclusion

The regulatory situation surrounding chlorpyrifos products is expected to remain uncertain. While EPA's recent action reaffirms the current legal status of chlorpyrifos tolerances, it suggests that this reinstatement may be reversed in the future for most uses. Additionally, EPA plans to introduce further restrictions for the remaining uses. During this transitional period, all chlorpyrifos product applications must adhere to existing cancellation orders, including provisions for existing stocks.

On 4 January 2024, the New York State Department of Environmental Conservation proposed to add limits for 1,4-dioxane in household cleansing, personal care, and cosmetic products to the New York Codes...

On 4 January 2024, the New York State Department of Environmental Conservation proposed to add limits for 1,4-dioxane in household cleansing, personal care, and cosmetic products to the New York Codes, Rules, and Regulations by Statutory authority.  

1,4-dioxane is a byproduct of the manufacturing process for some surfactants contained in cleaning products and detergents and is not an intentionally added ingredient. 

Content of the proposed rule:   

The New York Department of State has received a Notice of Proposed Rulemaking from the New York State Department of Environmental Conservation (NYS DEC). The changes to Article 35 and Article 37 of the Environmental Conservation Law (ECL), which were adopted in 2019, will be put into effect by this rulemaking. These modifications set limits on the quantity of 1,4-dioxane that can be found in cosmetics, personal care, and household cleaning products that are sold in the State. 

The ECL sets a maximum permissible concentration of 1,4-dioxane for household cleaning and personal care products of 2 parts per million (ppm) by December 31, 2022, and 1 ppm effective by 31, 2023, and 10 ppm by December 31, 2022, for cosmetic products. The US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) database classifies 1,4-dioxane as "likely to be carcinogenic to humans." However, despite the known health risks, 1,4-dioxane is still present in many consumer goods, including shampoos, detergents, deodorants, and cosmetics. 

Public comments 

An online public comment hearing on the proposed rule was held by an Administrative Law Judge (ALJ) on February 6, 2024. 

Further details on the proposed rule can be found here. 

On January 17, 2024, the Food and Drug Administration (FDA) announced the filing of a food additive petition on behalf of the Environmental Defense Fund and others, requesting that the food additive r...

On January 17, 2024, the Food and Drug Administration (FDA) announced the filing of a food additive petition on behalf of the Environmental Defense Fund and others, requesting that the food additive regulations be amended to eliminate four specific solvents. The food additive petition was filed on December 21, 2023. Comments are due March 11, 2024. 

Content of the food additive petition 

The petition seeks to eliminate the solvents benzene, trichloroethene, ethylene dichloride, and methylene chloride under the procedures for amending or repealing a food additive regulation in § 171.130 (21 CFR 171.130). The petitioners allege that these substances are not safe under the Delaney Clause because they have been found to induce cancer in humans and animals. 

According to the Delaney Clause, no food additive may be considered safe if it is found to cause cancer in humans or animals when consumed, or if it is found to cause cancer in humans or animals after studies appropriate for determining the safety of food additives. The petitioners have argued that 21 CFR 25.32(m), which refers to actions intended to restrict, or reduce the use of a substance in food, food packaging, or cosmetics, clearly excludes this action. 

Further details can be found here.  

Electronic Submissions 

 Electronic comments may be submitted as follows:  

• Submit either electronic or written comments on the filing notice by March 11, 2024. 

• Late, untimely filed comments will not be considered. The electronic filing system at https:// www.regulations.gov. will accept comments until 11:59 p.m. Eastern Time at the end of March 11, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. 

On February 16, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension of the submission deadline for the annual electronic reporting mandated under the Toxic Substances Control ...

On February 16, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension of the submission deadline for the annual electronic reporting mandated under the Toxic Substances Control Act (TSCA). Specifically, this extension applies to polymers manufactured under the terms of the polymer exemption for new chemicals. The new deadline for submission is March 31, 2024.

EPA cites technical difficulties with the launch of the new electronic reporting tool as the primary reason for the extension. The Agency aims to give manufacturers sufficient time to submit their reports and accompanying claims using the updated tool.

Reporting Requirements:

Under the polymer exemption, companies may manufacture polymers that meet the exemption criteria without the need for a premanufacture notice or exemption notice under the TSCA New Chemicals Program.

While exemption from certain notices is granted, there are still recordkeeping requirements to ensure compliance. Manufacturers of exempted polymers must submit an annual report on the number of exempted polymers manufactured or imported during the preceding calendar year.

Under EPA regulations, manufacturers (including importers) of polymers manufactured under the exemption must submit a report of manufacture or import by January 31 of the following year. In June 2023, EPA amended the reporting requirement to require electronic submission. To determine if your company is subject to this regulation, it is advised to review the applicability criteria outlined in 40 CFR 723.250.

Submission Process:

Reports and accompanying claims must be submitted electronically through EPA's Central Data Exchange (CDX) using the TSCA Section 5 Notices and Supports—ePMN application.

On February 1, 2024, the U.S. Environmental Protection Agency (EPA) announced its initiatives aimed at protecting communities and the environment from the health risks associated with some per- and po...

On February 1, 2024, the U.S. Environmental Protection Agency (EPA) announced its initiatives aimed at protecting communities and the environment from the health risks associated with some per- and polyfluoroalkyl substances (PFAS). These chemicals, known for their widespread use and persistence, pose health concerns as they degrade slowly over time and have been used in various consumer, commercial, and industrial products.

To comprehensively address PFAS pollution, EPA is proposing two regulatory updates.

1. EPA is proposing to modify the definition of hazardous waste for cleanups at permitted hazardous waste facilities. This modification aims to ensure that EPA's regulations accurately reflect its authority under the Resource Conservation and Recovery Act (RCRA), to mandate cleanup of chemicals including emerging chemicals of concern, such as PFAS.

2. EPA is proposing to amend its RCRA regulations to designate multiple PFAS compounds as hazardous constituents. These additions would prompt the inclusion of PFAS in facility assessments and, where necessary, further investigation and cleanup through the corrective action process at hazardous waste treatment, storage, and disposal facilities.

These proposed rules are designed to strengthen protections for communities and drinking water supplies near the 1,740 permitted hazardous waste facilities nationwide. Under RCRA's corrective action provisions, hazardous waste facilities must investigate and clean up hazardous releases to soil, groundwater, surface water, and air to protect human health and the environment.

EPA plans to publish these proposals in the Federal Register in the coming weeks. The proposed rule entitled "Definition of Hazardous Waste Applicable to Corrective Action from Solid Waste Management Units" will be open for public comment for 30 days, while the proposed rule entitled "Listing of Specific PFAS as Hazardous Constituents" will be open for public comment for 60 days. Upon publication, EPA encourages public comment on each proposal.

Following its November 2023 commitment to gather data on the widely used tire additive 6PPD and its chemical by-product 6PPD-quinone, the U.S. Environmental Protection Agency (EPA) has announced the r...

Following its November 2023 commitment to gather data on the widely used tire additive 6PPD and its chemical by-product 6PPD-quinone, the U.S. Environmental Protection Agency (EPA) has announced the release of a draft testing method (EPA Method 1634) on January 30, 2024. This method will allow government agencies, tribes, and other organizations to determine the presence of 6PPD-quinone in local stormwater and surface water.

About 6PPD

Vehicle tires contain the chemical 6PPD (chemical name: N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine) to prevent degradation from reactions with ozone and reactive oxygen species. When 6PPD reacts with ozone, it forms 6PPD-quinone. As tires wear down, particles are released into the environment, and when it rains, stormwater washes these particles into waterways, potentially exposing aquatic organisms to 6PPD-quinone.

Research indicates that 6PPD-quinone is toxic and can swiftly kill certain fish. A 2021 publication in the journal Science linked coho salmon deaths to 6PPD-quinone in stormwater, with lethal concentrations found within a few hours of exposure. Other fish species were also identified as vulnerable.

Apart from being used in tires for more than six decades, 6PPD is also present in various rubber products, including footwear, synthetic turf infill, and playground surfaces. EPA’s draft analytical method for detecting 6PPD-quinone is now widely available, providing tribes and local governments with a crucial tool to better understand stormwater and surface water quality. This assists in determining how to protect vulnerable aquatic creatures like salmon and trout from potential harm caused by runoff.

Draft Method 1634: Detecting 6PPD-Quinone in Water

This method uses liquid chromatography with tandem mass spectrometry (LC/MS/MS) to analyze water samples for 6PPD-quinone.

1. Samples are prepared and extracted using solid-phase extraction (SPE). An aliquot of the extracted solution is spiked with an internal standard and brought to a final volume.
2. The extract is injected into an HPLC system with a tandem mass spectrometer. 6PPD-quinone is identified by comparing mass transitions and retention time with reference spectra.
3. Quantitative determination of 6PPD-quinone concentration is performed using primary quantitation ions and corrected for recovery using isotope dilution.

This method ensures accurate analysis through reproducible calibration and testing of equipment.

Additional research

EPA is actively funding and conducting research to better understand the effects of 6PPD-quinone and to address data gaps, including the development of an analytical method. Specifically:

• EPA's Office of Research and Development is studying the fate and transport of these chemicals in air and water, their effects on ecosystems, and strategies for mitigating stormwater contamination.
• EPA's Office of Water is developing draft screening values for 6PPD-quinone and 6PPD in water to protect sensitive aquatic life. These values can be used by various parties for monitoring and water quality protection programs.
• EPA is collaborating with the National Science and Technology Council on potential research on the human health effects of 6PPD-quinone.