USA Regulatory News

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 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.

On January 9, 2024, the U.S. Environmental Protection Agency (EPA) announced that seven per- and polyfluoroalkyl substances (PFAS) have been automatically added to the list of chemicals covered by the...

On January 9, 2024, the U.S. Environmental Protection Agency (EPA) announced that seven per- and polyfluoroalkyl substances (PFAS) have been automatically added to the list of chemicals covered by the Toxics Release Inventory (TRI). 

The TRI was expanded to include seven additional PFAS in accordance with the National Defense Authorization Act (NDAA) for Fiscal Year 2020. This addition is part of EPA's efforts to better understand and protect people from chemicals such as PFAS. The NDAA established a framework for the annual automatic addition of PFAS to TRI in response to specific EPA activities involving PFAS. The total number of PFAS subject to reporting requirements is now 196.  

Because EPA determined a toxicity value in 2023 for the six PFAS listed below, they were automatically added for the Reporting Year 2024. This data helps communities understand how local facilities are handling the listed chemicals; supports informed decisions by the public, businesses, government agencies, and non-governmental organizations (NGOs); and advances the Biden-Harris commitments to ensure environmental justice. 

Addition of PFAS no longer claimed as confidential business information. 

EPA is required to assess claims of confidential business information (CBI) before adding a PFAS to the Toxic Substances Control Act Inventory List. One PFAS was nominated for inclusion but was not added due to CBI claims over its identity. In February 2023, the compound's identity was declassified, and the following chemical was added because its identity is no longer classified. This process ensures that the TRI list is up-to-date and protects chemical identification. 

• Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CASRN 2816091-53-7 

Section 313 of the Emergency Planning and Community Right-to-Know Act requires facilities that report on PFAS to start tracking their actions by January 1, 2024, with reporting forms due by July 1, 2025. EPA must assess claims of confidential business information before adding a PFAS to the TRI list.  

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) finalized a Significant New Use Rule (SNUR) that prevents companies from resuming or initiating the production or processing of 329 ...

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) finalized a Significant New Use Rule (SNUR) that prevents companies from resuming or initiating the production or processing of 329 per- and poly-fluoroalkyl substances (PFAS) that have been inactive for years without a comprehensive EPA review. These "inactive PFAS" were previously used in various industries without proper assessment and pose potential environmental risks. The rule aligns with the Biden-Harris Administration's three-year commitment to environmental justice, public health protection, and addressing the impacts of these persistent "forever chemicals" under the PFAS Strategic Roadmap.

History

When the Toxic Substances Control Act (TSCA) was enacted in 1976, it grandfathered in thousands of chemicals, allowing them to remain in commerce without additional EPA review. For the first 40 years, only about 20% of new chemicals underwent formal EPA review, and the Agency lacked the authority to address chemicals without sufficient information. This gap led to the introduction of PFASs into commerce without comprehensive reviews.

The 2016 TSCA amendments, part of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, mandate a formal safety review for all new chemicals before they enter commerce. The new Significant New Use Rule (SNUR) requires EPA to conduct thorough reviews before inactive PFASs can be reused. TSCA also mandates EPA to maintain and publish the TSCA Inventory, which designates each chemical as "active" or "inactive" in commerce. An "inactive" status indicates that a chemical has not been manufactured (including imported) or processed in the U.S. since June 21, 2006.

The current regulation applies to all PFAS labeled as "inactive" on the TSCA Inventory and not under a SNUR, adhering to the reporting criteria outlined in the Active-Inactive rule for these specified chemicals.

Process

Companies wishing to use any of the 329 chemicals must notify EPA beforehand. EPA will then conduct a thorough review of health and safety data to assess potential risks to human health or the environment, following the guidelines of the updated 2016 law. Any necessary restrictions will be imposed before the new use can commence. The evaluation of new PFAS and their uses falls under EPA's framework, which was introduced in June 2023.

On December 14, 2023, the U.S. Food and Drug Administration (FDA) has updated the instructions for reporting severe adverse events for cosmetic products as mandated by the Modernization of Cosmetics R...

On December 14, 2023, the U.S. Food and Drug Administration (FDA) has updated the instructions for reporting severe adverse events for cosmetic products as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA requires reporting of serious adverse events from December 29, 2023. 

A responsible person  must notify the FDA within 15 working days of significant adverse events involving cosmetic goods in the U.S., including a copy of the labeling on the retail packaging of the product. Additional medical or other information received by the responsible person within one year of the initial report, must be submitted to the FDA within 15 business days. 

The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product's label in accordance with section 4(a) of the Fair Packaging and Labeling Act or section 609(a) of the FD&C Act is considered. 

A serious adverse event is defined as an event that:  

(A)  Results in: 

• death  

• a life-threatening experience 

• inpatient hospitalization 

• a persistent or significant disability or incapacity 

• a congenital anomaly or birth defect 

• an infection 

• significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant change of appearance), other than as intended under customary or usual conditions of use. 

B) Necessitates a medical or surgical intervention based on reasonable medical judgment in order to  prevent an outcome mentioned in (A) above.

The FDA updated the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) web page in November 2023, recommending that industry responsible persons use the current MedWatch Form 3500A, which can be downloaded and completed at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF), to submit serious adverse event reports for cosmetics.