USA Regulatory News

On November 10, 2025, the U.S. Environmental Protection Agency (EPA) proposed revisions to the perfluoroalkyl and polyfluoroalkyl substances (PFAS) reporting requirements under the Toxic Substances Co...

On November 10, 2025, the U.S. Environmental Protection Agency (EPA) proposed revisions to the perfluoroalkyl and polyfluoroalkyl substances (PFAS) reporting requirements under the Toxic Substances Control Act (TSCA). These changes aim to make reporting more practical and implementable while reducing unnecessary or duplicative burdens on businesses, particularly small manufacturers and importers.

Background: One-Time PFAS Reporting Rule Finalized in 2023

In October 2023, EPA finalized a one-time PFAS reporting rule under TSCA section 8(a)(7). This rule required manufacturers (including importers) to report data on PFAS use, exposure, and health effects for any year between 2011 and 2022. However, the rule was criticized for imposing nearly $1 billion in compliance costs without clear implementation standards or demonstrated environmental benefits.

Key Proposed Exemptions

The new proposal seeks to maintain essential reporting requirements while exempting activities for which manufacturers are least likely to have information or be able to make reasonable determinations. Key proposed exemptions include:

• PFAS in mixtures or products at concentrations of 0.1% or lower
• Imported articles
• Certain byproducts and impurities
• Research and development chemicals
• Non-isolated intermediates

EPA also plans to make technical corrections to clarify reporting fields and adjust the data submission period.

The agency will accept public comments for 45 days following publication of the proposal in the Federal Register. Comments should be submitted to docket EPA-HQ-OPPT-2020-0549 at https://www.regulations.gov.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has announced a public data call-in on the reproductive toxicity of p,pʹ-bisphenol chemical...

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has announced a public data call-in on the reproductive toxicity of p,pʹ-bisphenol chemicals (CAS no. 2167-51-3), including their ethers and esters. This initiative is part of OEHHA’s implementation of Proposition 65, which requires the state to identify chemicals known to cause reproductive harm.

Purpose of the Review

OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC) will evaluate whether p,pʹ-bisphenol chemicals should be listed under Proposition 65. The OEHHA is currently developing hazard identification materials to support this review.

Information Requested

The OEHHA invites the public and stakeholders to submit relevant scientific data, including:

• Animal studies on developmental and reproductive toxicity
• Human epidemiological studies
• Mechanistic studies on reproductive or developmental toxicity
• Research on pharmacokinetics
• Effects on biochemical and physiological processes, including human data

Submission Details

The 45-day comment period runs from October 17 to December 1, 2025. Submissions can be made:

• Electronically via OEHHA’s website: https://oehha.ca.gov/comments
• By mail to Tina Cox, OEHHA, P.O. Box 4010, Sacramento, CA 95812-4010
• In person at 1001 I Street, Sacramento, CA 95814

The OEHHA encourages submissions in formats compliant with Section 508 and WCAG 2.1 accessibility standards.

Next Steps

Once all data has been compiled, the hazard identification materials will be made available for public comment. These materials and public feedback will then be reviewed by DARTIC before any listing decision is made. Meeting details will be published in the California Regulatory Notice Register and on OEHHA’s website.

For inquiries, contact Tina Cox at tina.cox@oehha.ca.gov or (916) 327-7338.

Public comments can be accessed here.

On October 7, 2025, the U.S. Environmental Protection Agency (EPA) announced the automatic addition of sodium perfluorohexanesulfonate (PFHxS-Na) (CAS No. 82382-12-5) to the Toxics Release Inventory (...

On October 9, 2025, the U.S. Environmental Protection Agency (EPA) opened a 30-day public comment period on its 2024 final risk management rule for carbon tetrachloride (CTC) under the Toxic Substance...

Update 20 November 2025:The U.S. Environmental Protection Agency (EPA) has rescheduled the Science Advisory Committee on Chemicals (SACC) preparatory meeting which will be held virtually to December ...

Update 20 November 2025:

The U.S. Environmental Protection Agency (EPA) has rescheduled the Science Advisory Committee on Chemicals (SACC) preparatory meeting which will be held virtually to December 1, 2025. Participants who wish to present oral comments must register by November 24, 2025, at 12:00 p.m. EST, and submit written versions of their comments by November 28, 2025, at 12:00 p.m. EST. The SACC peer review meeting remains scheduled for December 2–5, 2025.

EPA has also extended the public comment period for the draft risk evaluation by 15 days. The new deadline is December 2, 2025. Comments should be submitted to docket EPA-HQ-OPPT-2018-0443 on https://www.regulations.gov.

Original News:

On September 17, 2025, the U.S. Environmental Protection Agency (EPA) has released a draft risk evaluation for Octamethylcyclotetrasiloxane (D4) under the Toxic Substances Control Act (TSCA). The agency’s initial findings indicate that D4 may pose unreasonable risks to human health and the environment under certain conditions of use.

Key Findings: Risks to Human Health

EPA identified 23 conditions of use (COUs) where workers face potential risks, particularly during the manufacture of D4 and in processing activities involving adhesives, sealants, paints, and coatings. In addition, one consumer COU involving D4 in paints and coatings was flagged for unreasonable risk.

The draft evaluation clarifies that these determinations do not assume the use of personal protective equipment (PPE). While PPE may reduce exposure, EPA emphasizes that risk exists without its consistent use. Importantly, no unreasonable risks were identified for the general population.

Key Findings: Environmental Risks

EPA’s draft evaluation also highlights seven COUs where D4 could pose risk to the environment. For another 18 environmental COUs and two human health COUs, the agency has not yet reached preliminary conclusions.

Scientific Insights

The draft incorporates recent studies on bioaccumulation and biomagnification of D4. Studies show D4 can accumulate in aquatic organisms but has a low likelihood of biomagnifying through the food chain, as fish are able to metabolize ingested D4. These findings suggest that while exposure occurs, accumulation across trophic levels may be limited.

Public Comment and Review

EPA is inviting public comments until November 17, 2025, through docket EPA-HQ-OPPT-2018-0443 on Regulations.gov.

Two public meetings are planned:

• Preparatory meeting – November 18, 2025
• Peer review meeting – December 2–5, 2025, led by the Science Advisory Committee on Chemicals (SACC)

Participants may submit written feedback or request to present oral comments by the deadlines listed on the SACC website.

Next Steps

Following the comment period and peer review, EPA will finalize the risk evaluation. If unreasonable risks are confirmed, the agency may propose risk management actions to reduce exposure to D4 in workplaces, consumer settings, and the environment.

On 12 September 2025, The U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive platform designe...

On 12 September 2025, The U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive platform designed to provide real-time access to adverse event reports related to cosmetic products. The launch, announced via a FDA press release, supports the FDA’s broader modernization strategy and responds to growing demand for transparency in product safety.

The dashboard covers a wide range of cosmetic categories, such as moisturizers, shampoos, conditioners, hair dyes, and tattoos.

FDA Adverse Event Reporting System (FAERS)

The launch of the cosmetic products dashboard is part of the FDA’s borader push for transparency, complementing earlier initiatives such as real-time reporting of adverse events and medication errors for drugs and therapeutic biologics.

The new platform centralizes reports exclusively related to cosmetic products, including those required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and voluntary submissions from healthcare professionals, consumers, and cosmetic industry professionals.

Key Features of the FAERS Dashboard

• Real-time Access: Reports updated daily with downloadable datasets.
• Comprehensive Search: Filter by product, event, severity, date, or type.
• Public Transparency: Addresses demand for safety visibility.
• Limitations: Reports are unverified and do not establish causation or confirm product safety.



Stakeholder Obligationsunder MoCRA

MoCRA requires companies are required to submit serious adverse event reports for cosmetic products to the FDA. Other stakeholders, inlcuding healthcare professionals, salon professionals, cosmetologists, and consumers are encouraged to voluntarily report incidents to strengthen safety surveillance.

While the dashboard enhances transparency, the FDA notes that the data is intended for monitoring purposes only.  Companies are expected to evaluate safety signals proactively and take mitigation measures when risks are identified.

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