USA Regulatory News

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. 

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) introduced a new framework for identifying eye irritation and corrosion hazards in new chemicals evaluated under the Toxic Substances...

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) introduced a new framework for identifying eye irritation and corrosion hazards in new chemicals evaluated under the Toxic Substances Control Act (TSCA). This standardized approach aims to enhance transparency and consistency in final risk assessments. The framework aligns with EPA's commitment to reduce animal testing, increase the efficiency of chemical reviews, and expedite market entry while safeguarding human health.

As part of TSCA requirements, EPA must assess new chemicals within 30 or 90 days, identify potential hazards and conduct risk assessments. Evaluation of eye irritation or corrosion is an integral part of this process. Traditionally, animal testing using rabbits was employed for this purpose, but its inconsistency, especially for mild to moderate irritation, has raised concerns about its applicability to humans.

HIGHLIGHT OF THE FRAMEWORK

The new framework is aimed at promoting alternative test methods known as New Approach Methodologies (NAMs). These methods eliminate or reduce testing on vertebrate animals while maintaining scientific rigor in assessing chemical hazards. In addition to promoting ethical practices, the transition to NAMs is expected to save time and money for stakeholders by eliminating the necessity for animal studies.

By emphasizing reproducible data, EPA aims to streamline decision-making by ensuring a standardized process for evaluating eye irritation or corrosion hazards in new chemical test data. It relies on peer-reviewed literature, accepted Organization for Economic Cooperation and Development (OECD) test guidelines, and other recognized risk assessments.

A BRIEF OVERVIEW OF THE FRAMEWORK

• Available data on the chemical substance are evaluated for quality and applicability.
  • Data are prioritized in the following order:
    • Data from human cell or tissue test methods.
    • Data from in-chemico, in vitro, or ex vivo test methods.
    • Data from in vivo test methods.
  • Where data from eye irritation or corrosion tests are not available, test methods that assess skin irritation or corrosion potential may be considered. 
• If eye and skin irritation or corrosion data are not available, other information may be considered. Where no data exists, a hazard determination may not be possible.
• Any relevant human data will be evaluated and incorporated on a case-by-case basis. 

EPA’s New Chemicals Program (NCP) prioritizes the use of methods that use sensitive human cells or tissues to identify non-irritating chemicals, such as OECD TG 492 (1). For the identification of irritating or corrosive chemicals, the NCP favors methods using human cells or tissues capable of assessing the full severity range, such as OECD TG 492B (2), along with reproducible and relevant in chemico, in vitro, or ex vivo methods. The NCP does not recommend the prospective use of the in vivo eye irritation test using live rabbits, such as the Draize test.

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by th...

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance supports stakeholders in submitting cosmetic product facility registrations and product listings to the FDA. It outlines submission responsibilities, necessary information, submission procedures, timelines, and specific exemptions from registration and listing requirements.

Portal

The guidance provides details about a newly launched electronic registration and listing portal called Cosmetics Direct. This portal is now accessible. Additionally, the FDA is in the process of creating paper forms, Form FDA 5066 and Form FDA 5067, to serve as alternative tools for submitting cosmetic product registration and listing information. These forms are expected to be available soon on the Registration & Listing of Cosmetic Product Facilities and Products platform.

The FDA will use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. To streamline the registration process, facility owners or operators are required to obtain an FEI number before submitting their facility registration. To check for an existing FEI number, please use the FEI Search Portal.

It is important for the responsible person to obtain the relevant FEI number(s) for each facility where their cosmetic products are manufactured or processed, as these facility registration number(s) are necessary for product listing submissions. In the case of a small business that is exempt from registration and does not have a facility registration number, the product listing can be submitted using the facility name and address.

Exemptions

MoCRA provides exemptions from facility registration and product listing for specific small businesses.

However, these exemptions do not apply to facilities or responsible persons associated with the manufacture or processing of certain cosmetic products, including the following:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that, under customary or usual conditions of use, are intended to change the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use. 

Delayed Enforcement 

The FDA will not enforce the cosmetic product facility registration and product listing requirements for an additional six months after the December 29, 2023 deadline, until July 1, 2024. During this period, regulated industries will have more time to meet these obligations.

Additionally, the FDA will not enforce the registration requirement for facilities that begin cosmetic product manufacturing or processing after December 29, 2022, and the listing requirement for products first marketed after that date until July 1, 2024.

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a rep...

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a reproductive toxicant, specifically targeting the female reproductive endpoint. The decision, made through the "State's Qualified Experts" mechanism, follows the conclusive findings of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) that BPS is a contributor to female reproductive toxicity.

The listing of BPS under Proposition 65, effective from December 29, 2023, highlights the potential hazards of the substance and necessitates warning requirements for significant exposures.

During the DARTIC meeting, OEHHA staff presented a comprehensive review of the scientific evidence regarding the female reproductive toxicity of bisphenol S. Following the presentation, the DARTIC voted unanimously (9-0) in favor of the determination that BPS induces female reproductive toxicity based on scientifically valid testing according to widely accepted principles. This led to the addition of BPS to the Proposition 65 list, specifically for female reproductive toxicity.

Proposition 65

Proposition 65, established in November 1986 as a ballot initiative, protects California’s drinking water sources from contamination by chemicals known to cause cancer, birth defects, or other reproductive harm. It requires businesses to inform Californians of potential exposure to such chemicals and to provide warnings.

These chemicals may be present in products, homes, workplaces, or released into the environment. Proposition 65 empowers Californians to make informed decisions about their chemical exposures and prohibits businesses from knowingly discharging significant amounts of listed chemicals into drinking water sources.

Understanding Bisphenol S

Bisphenol S (BPS) is a constituent of polyethersulfone (PES) plastic, commonly used in the manufacture of rigid plastic products and synthetic fibers used in clothing and textiles. Beyond its application in curing fast-drying epoxy glues, BPS serves as a corrosion inhibitor and is frequently used as a reactant in polymer reactions. BPS can improve color longevity in fabrics and is often chosen as a substitute for BPA in certain paper receipts. It can also be found in the protective coatings that line some food cans, and consumers should be aware that products labeled as "BPA-free" may contain BPS. The common characteristic of BPS and BPA as endocrine disruptors lies in the presence of the hydroxy group on the benzene ring, enabling them to mimic estradiol.

These developments highlight the ongoing efforts to identify and regulate potentially harmful substances. As stakeholders navigate these changes, it is increasingly important to stay informed about chemical listings and associated warnings.

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation...

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation under the Toxic Substances Control Act (TSCA). Chemical companies will be required to submit records of the significant adverse impacts on human health and the environment caused by MBOCA. This action is consistent with EPA's mission to protect human health and the environment.  

EPA is collecting environmental and health data on a chemical for the first time in over 30 years, hoping that the data will improve its understanding of the chemical's potential adverse effects on human health or the environment and streamline the risk assessment process. 

MBOCA is used in various industrial applications, particularly in the manufacturing and processing of rubbers, plastics, polymers, resins, and other compounds. MBOCA is a potential human carcinogen, and its inclusion in the 2014 update to the TSCA Work Plan, indicates the need for more evaluation. EPA expects to start a risk review of MBOCA within 9-12 months, as the Agency recently started the statutory priority process for five chemicals, including MBOCA.  

Chemical companies are required to keep records of any reports regarding the chemical's adverse effects on the environment or human health. EPA is authorized by TSCA Section 8(c) to obtain copies of these records. 

EPA has published a Quick Guide to CDX Submissions and a TSCA Section 8(c) Recordkeeping and Reporting Fact Sheet to help respondents in meeting their obligations. Records should be submitted using the Agency's online Central Data Exchange (CDX) system.