FDA Withdraws Asbestos Testing Proposal for Talc Cosmetics

/in , , , ,

On November 28, 2025, in response to adverse comments, FDA published a notice announcing its withdrawal a December 2024 proposed rule that would have required manufacturers of talc-containing cosmetic products to test for asbestos.

The rulemaking is required by section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directs FDA to “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.”  FDA’s notice makes clear that the agency plans to issue a new proposed rule in the future.

FDA cites “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received, and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” as good cause for the withdrawal.

The concern underlying the rulemaking stems from the geological relationship between asbestos and talc.  According to FDA, asbestos is found in the same rock types that host talc deposits, which sometimes results in the presence of asbestos in talc cosmetics.

Although the testing requirements will not take effect, the Federal Food, Drug, and Cosmetic Act (FFDCA) continues to prohibit the sale of adulterated cosmetics, including those that contain “any poisonous or deleterious substance which may render [the product] injurious to users.”  FDA has previously taken action in this area: testing in 2019 led to recalls of talc cosmetics potentially containing asbestos, while testing in 2023 did not detect asbestos in any of fifty sampled products.

December 2024 Proposal

The December 2024 proposed rule would have required manufacturers to test talc-containing cosmetic products—or the talc ingredient before use—and maintain records demonstrating compliance. Manufacturers would have needed to test a representative sample of each batch or lot using both:

  1. Polarized Light Microscopy (PLM) (with dispersion staining).
  2. Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).

Noncompliance would have rendered a cosmetic adulterated.  A talc cosmetic product would also have been deemed adulterated if any asbestos was present—even if only a single fiber was detected.

Issues Raised by Commenters

In the withdrawal notice, FDA notes several provisions of the proposed rule that were contested by commenters, including:

  • The proposed definition of “asbestos,” which differed from definitions used by OSHA, the Mine Safety and Health Administration (MSHA), and EPA.
  • Whether FDA has statutory authority to add a specific adulteration provision relating to talc testing or to deem any detectable asbestos as adulterating a cosmetic.
  • FDA’s inclusion of cosmetic products that are also drugs within the scope of the rule.

In addition, commenters raised concerns about the proposed test methods, although FDA did not address these in the withdrawal notice.  For example, the United States Pharmacopeia (USP) questioned whether TEM was superior to other test methods, arguing that it might yield more false positives.  USP also asserted that a single-fiber threshold for positive samples diverges from generally accepted TEM fiber counting procedures and would pose challenges for reproducibility.

More information on talc and asbestos can be found on FDA’s website.

EPA to Reconsider TSCA Section 8(d) Reporting Rule

/in , ,

On November 24, 2025, EPA announced that it will reconsider a December 2024 Toxic Substances Control Act (TSCA) rule requiring manufacturers of sixteen chemical substances to submit unpublished health and safety information to the agency.

In the press release, EPA said that it “expects to consider additional exemptions for manufacturers required to report, a regulatory threshold for reporting, and a change to the duration of the lookback period for reporting.”  However, “EPA is not considering changing the 16 chemicals named in the rule as part of this action.”

EPA also noted that it “anticipates taking appropriate action on the reporting deadline (May 22, 2026) associated with the current” rule.

On the same day, EPA asked the D.C. Circuit go continue holding a legal challenge to the rule in abeyance while the agency reconsiders the rule.  The court granted EPA’s motion on November 25, 2025.

A list of the sixteen chemical substances listed by the rule can be found in a previous post.

Current Requirements

The rule, promulgated under TSCA section 8(d), requires manufacturers that manufactured (or proposed to manufacture) any of the listed substances during a ten-year lookback period to submit copies of health and safety studies in their possession.  In addition, manufacturers currently manufacturing (or proposing to manufacture) any of the substances must submit lists of ongoing studies, initiated studies, studies that are known to the manufacturer but not in its possession, and studies previously submitted to a federal agency without confidentiality claims.

Studies previously submitted to EPA under TSCA are exempt.  However, the rule does not exempt companies that imported one of the substances in an article, companies that manufactured one of the substances only as a byproduct or impurity, or include a de minimis threshold.

EPA initially set March 13, 2025, as the reporting deadline for most submissions, but later extended the deadline twice. The current reporting deadline is May 22, 2026.

More information on the rule can be found here.

Massachusetts Introduces Comprehensive Children’s Product Chemicals Regulation Bill

/in , , ,

On November 10, 2025, a Massachusetts state senator introduced a bill that would create an extensive regulatory program to restrict the use of chemicals of concern—including PFAS—in children’s products sold in the state.

If enacted, SB 2660 would prohibit the use of intentionally added PFAS in children’s products above a total organic fluorine threshold set by the Massachusetts Department of Environmental Protection (MassDEP).  It would also allow MassDEP to screen chemicals, identify priority substances, and require their disclosure and eventual substitution in children’s products.

Children’s products are broadly defined as items “intended, made or marketed for use by children 12 years of age or under,” including toys, clothing, cosmetics, and jewelry, with specific exemptions (e.g., electronics and bicycles).  The bill applies only to new products.  SB 2660 adopts a familiar definition of PFAS: “any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”

Regulatory Structure

SB 2660 would require that MassDEP create two primary public lists of chemicals:

  1. Chemicals of concern in children’s products
  2. High priority chemicals

The chemicals of concern list would include a broad set of chemicals that may pose hazards in children’s products. Listing would trigger manufacturer reporting.

The high priority chemicals list would be a narrower subset of chemicals of concern, elevated based on evidence of exposure or other regulatory triggers.  Placement on this list would initiate stronger obligations, including substitution and, eventually, sale prohibitions.

Chemicals of Concern List & Requirements

A chemical may be placed on the chemicals of concern list if it is identified as:

  • A carcinogen or mutagen
  • Persistent or bio-accumulative and toxic (PBT)
  • An endocrine disruptor
  • A reproductive or developmental toxicant
  • A neurotoxicant
  • A respiratory or skin sensitizer
  • Any other chemical of equivalent concern

Within 180 days of listing, and biennially thereafter, manufacturers of children’s products containing a chemical of concern above de minimis levels would be required to notify MassDEP.  Notifications would be made available to the public, and would be required to include:

  • Chemical name
  • Product description
  • Brand, model, and UPC (if applicable)
  • Chemical function in the product
  • Amount of the chemical (ranges permitted)
  • Company and contact information
High Priority Chemicals List & Requirements

MassDEP would be allowed to elevate a chemical of concern to the high priority list if:

  • The chemical or its metabolites are found in humans through biomonitoring
  • The chemical is detected in household dust, indoor air, drinking water, or other home environments
  • The chemical is shown to release from a product, leading to likely exposure to children
  • The chemical or products containing it are restricted in another state

Manufacturers of children’s products containing a high priority chemical would be required to notify downstream sellers within 180 days of listing.

Within three years of listing, high priority chemicals would be required to be removed or substituted in children’s products that are (1) mouthable, (2) personal care products or cosmetics, or (3) intended for children under three.

Within five years, high priority chemicals would be prohibited in all children’s products unless preempted by federal law or if MassDEP determines that a ban would pose an unreasonable risk to public health, safety, or welfare.

Chemical Substitutions

SB 2660 also authorizes MassDEP to publish a safer alternatives list.  Manufacturers would be freely allowed substitute high priority chemicals with listed safer alternatives.

If a manufacturer chooses a substitute not on the safer alternatives list, MassDEP approval would be required.  Manufacturers would be required to explain how the product is less hazardous, and MassDEP may require submission of a hazard assessment.

Manufacturers may not replace a high priority chemical with a chemical of concern.

Exceptions and Extensions

SB 2660 includes several provisions to ease compliance:

  • MassDEP may grant temporary or permanent waivers from substitution requirements if exposure is not reasonably anticipated.
  • Manufacturers with 25 or fewer employees may apply for a two-year extension to the deadlines resulting from high priority listing.
  • MassDEP may not impose a lower allowable level than a federal consumer product safety standard unless it completes a rulemaking.
  • Additional exemptions may be established by regulation.
Enforcement and Other Provisions

MassDEP would have authority to adopt rules, test children’s products, and impose civil penalties of $5,000 per violation (or up to $10,000 for repeat violations).

Every three years, MassDEP would be required to publish a report on toxic chemicals in children’s products, including reporting outcomes and policy recommendations.

* * *

Verdant Law closely monitors state-level chemical regulatory bills like SB 2660, including the rapidly expanding wave of PFAS-focused legislation.  Our team is ready to help your company assess potential compliance obligations, stay ahead of emerging requirements, and prepare for potential impacts across product lines and supply chains.

Groups Challenge EPA Rule Allowing PBTs in TSCA Exemption Reviews

/in , ,

New persistent, bioaccumulative, and toxic chemicals (PBTs) should not be eligible for expedited reviews under the Toxic Substances Control Act (TSCA) known as the low volume exemption (LVE) and low releases and exposures exemption (LoREX), environmental groups told the Ninth Circuit on October 17, 2025.

The lawsuit challenges EPA regulations finalized in December 2024 that allow companies to continue to continue to apply those exemptions for certain PBTs.  In their opening brief, the petitioners argue that the rule violates TSCA’s requirement that exemptions protect against unreasonable risk.

“The record, including EPA’s own findings, establishes that the category of new PBTs may—indeed, will likely—present unreasonable risk even when complying with the terms of the LVE and LoREX Exemptions,” the brief states.

Disputed Eligibility Standards

The 2024 rule made PFAS categorically ineligible for the exemptions, as well as PBTs “with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms.”  The petitioners contend that this “turns the statute on its head” because it requires that EPA affirmatively determine “that a specific PBT is unsafe” for it to be ineligible.

“In effect, the rule treats an absence of evidence as a reason to expedite the approval of a new PBT chemical, rather than a reason to deny an exemption application,” their brief states.

EPA justified its decision to allow certain PBTs to remain eligible by suggesting that PBT use may not always result in exposure, “such as chemical substances used in a closed system to make semiconductors.”  In the rule, EPA also stated that it “expects that most exemptions for PBT chemical substances will not be granted.”

The petitioners, however, describe EPA’s “zero-release-zero-exposure” scenarios as “fanciful.”   All “new PBTs will eventually be released into the environment, cause exposures, and thereby result in serious injury,” they argue.

Speedier Reviews

LVE and LoREX applications are subject to a 30 day review period, compared to 90-to-180 days for standard reviews, though review backlogs mean reviews often take much longer in practice.  The petitioners claim that LVE and LoREX reviews are less “detailed and comprehensive” than standard reviews, and observe that EPA does not require testing or impose additional restrictions on approved exemption applications—incentivizing companies to use them.

Publicly available EPA data shows that 221 valid LVEs were submitted in fiscal year 2025, which was greater than the number of standard review applications.  No LoREX submissions were received during the year, however.

In August 2025, EPA announced that it had made substantial progress on the LVE backlog thanks to process improvements.  However, its continued progress may be jeopardized by the ongoing government shutdown.

More on EPA’s 2024 new chemicals procedural rule can be found in a previous post.  The case is Alaska Community Action on Toxics v. EPA, No. 25-158 (9th Cir.), filed 1/10/2025.

Health and Safety Reporting Rule Finalized for 16 Chemicals

/in , ,

On December 13, 2024, EPA finalized a rule under the Toxic Substances Control Act (TSCA) requiring manufacturers of 16 chemical substances to submit unpublished health and safety studies to EPA.  The agency will use this information to inform possible evaluation and regulation of these substances under TSCA section 6.

Once the rule takes effect on January 13, 2025, covered entities will have 60 days to report unpublished health and safety information, which includes environmental monitoring data, studies on environmental effects, and tests on biological, photochemical, and chemical degradation.  Manufacturers must also submit lists of planned, ongoing, and known studies, even if the studies are not in their possession.

The rule requires manufacturers to submit these studies regardless of the level at which the substances are present in the evaluated media (e.g., air, soil, water, sediment, or biota).  That is, EPA opted not to include a minimum concentration level for these substances.  Historically, EPA has exempted studies in which a listed substance was only present as an impurity.  That is not the case here.

A complete list of the 16 chemicals can be found in a previous blog post.  On December 18, 2024, EPA initiated risk evaluations for five of these substances and began the prioritization process—an initial step before risk evaluation—for another five.  More on those actions can be found here.

Update

On March 6, 2025, EPA announced in an email that the agency will issue a rule to extend the reporting deadline by 90 days to June 11, 2025, for vinyl chloride and 180 days to September 9, 2025, for the other chemicals covered under the rule.

EPA’s TSCA Pre-Prioritization Webinar

/in , ,

On September 30, 2024, a lead toxicologist in the Data Gathering Management and Policy Division within the Office of Pollution Prevent and Toxics presented an overview of prioritization and pre-prioritization efforts for existing chemicals under the Toxic Substances Control Act (TSCA). The Agency’s goal was to collaborate with attendees to evaluate the potential risks of existing industrial chemicals regulated under TSCA. Topics covered included a high-level overview of TSCA authorities, requirements, and timelines for evaluating existing chemicals. Additionally, EPA covered the Agency’s approach for identifying the chemicals that may undergo prioritization.

Under TSCA, EPA is required to evaluate the potential risks of chemical substances comprehensively, taking into account their cradle-to-grave life cycle. This process involves assessing the chemical’s potential exposure and risks from production through disposal and includes all identified uses.  First, the webinar touched on the key aspects for the Risk Evaluation process.

  • Cradle-to-Grave Analysis
    • 6-Year Timeline for Risk Regulation
      • Initiation and Prioritization: 9-12 months.
      • Risk Evaluation: 3 to 3.5 years.
      • Regulation Development: Remainder of the timeline as needed.
  • Public Engagement and Information Gathering

EPA then noted that the prioritization process reflects the Agency’s evolving approach to addressing chemical risks efficiently and inclusively under TSCA. EPA identified 27 chemical substances that are being considered for prioritization under TSCA, focusing on their inclusion in the 2014 TSCA Work Plan, the interests of other agencies, and the availability of hazard and exposure data. The 2014 TSCA Work Plan identified approximately 90 chemicals as priorities for risk evaluation based on hazards, exposure risks, and their environmental or health impact. In addition, three chemical substances that were not listed in the 2014 Work plan are being considered for prioritization Two of these chemicals were identified through TSCA Section 21 petitions:  Hydrogen fluoride (HF) and 6PPD.  Bisphenol S (BPS) is also being considered for prioritization.  The Agency explained that BPS could become a priority if bisphenol A (BPA) undergoes prioritization, as BPS is a key alternative to BPA in the market.

EPA reminded participants that the Agency uses Section 4 and Section 8 under TSCA to gather data on the chemicals for prioritization, risk evaluation, and risk management. TSCA Section 4 provides authority for mandatory testing of chemicals to fill data gaps through test orders, test rules, and consent agreements. TSCA Section 8 allows for reporting and recordkeeping of existing chemical-related data, including reports of significant adverse health or environmental reactions.

The Agency noted that it prioritizes chemicals with robust existing data to streamline risk evaluation and reduce delays caused by insufficient information. The inclusion of both 2014 TSCA Work Plan chemicals and newly highlighted substances reflects intent to address historical priorities while also adapting to emerging concerns raised by stakeholders or other agencies.

 

Work Plan Chemicals:

1-Hexadecanol
2-Ethylhexyl
tetrabromobenzoate (TBB)
4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)
Benzene
bis(2-Ethylhexyl) – 3,4,5,6-Tetrabromophthalate (TBPH)
Bisphenol A
Creosote
Di-n-octyl phthalate (DnOP)
Ethylbenzene
Naphthalene
N-Nitroso-diphenylamine
p,p’-Oxybis(benzenesulfonylhydrazide)
Styrene
Tribromomethane
Triglycidyl isocyanurate
m-Xylene
o-Xylene
p-Xylene
Antimony & Antimony Compounds
Arsenic & Arsenic Compounds
Cobalt & Cobalt Compounds
Lead & Lead Compounds
Long-chain chlorinated paraffins (C18-20)
Medium-chain chlorinated paraffins (C14-17)

Non-Work Plan Chemicals:

Bisphenol S
Hydrogen fluoride
N-(1,3-Dimethylbutyl)-N’-phenyl-pphenylenediamine (6PPD)

DTSC Approves Preliminary Report on 6PPD Alternatives

/in , , ,

This August, the California Department of Toxic Substances Control (DTSC) approved a revised stage 1 alternatives analysis report for 6PPD (CASRN 793-24-8) from the U.S. Tire Manufacturers Association (USTMA).  The preliminary report identified seven potential 6PPD alternatives for use in tires, which will be further assessed in the stage 2 alternatives analysis report due in August 2026.

6PPD, or N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine, has been used as an anti-degradant in tires since about the 1950s.  In 2020, it was discovered that 6PPD has a transformation product, 6PPD-quinone, that is extremely toxic to salmon and other aquatic species.  According to USTMA’s website, the organization “is not aware of any new motor vehicle tires available today that do not contain 6PPD.”

The seven potential 6PPD alternatives identified by the preliminary report are 7PPD, IPPD, 77PD, CCPD, specialized graphene, octyl gallate, and Irganox 1520, selected based on available information on potential hazards, performance, and chemical and physical properties indicative of exposure potential.  7PPD, IPPD, 77PD, and CCPD come from the same chemical family as 6PPD.  Eliminating the use of 6PPD without replacement is not an option, according to the preliminary report.

The stage 2 alternatives analysis will include a “more in-depth evaluation of hazard and exposure potential,” including additional evaluation of potential transformation products.  “At the end of [stage 2], we are optimistic that we will have identified one or more possible alternatives that hold promise to replace or materially reduce 6PPD in motor vehicle tires,” the preliminary report states.

The initial report was revised due to a notice of deficiency issued by DTSC, which was described by USTMA as “a standard step in the alternatives analysis process” that allows “regulators to provide suggestions and seek clarification about certain parts of a preliminary submission.”  Octyl gallate and Irganox 1520 were added to the list of potential alternatives in the revised report.

DTSC added 6PPD to the list of Priority Products under California’s Safer Consumer Products Program effective October 2023, prompting the alternatives analysis.  The following month, EPA granted a Toxic Substances Control Act citizen petition requesting that EPA take action to prohibit its use in tires.  EPA has since proposed a data call for substances including 6PPD-quinone, discussed in a previous blog post.

EPA Proposes to Designate Five Substances as High Priority

/in , , ,

On July 25, 2024, EPA published a notice proposing to designate a new batch of existing chemicals as high priority substances under section 6 of the Toxic Substances Control Act (TSCA).  TSCA section 6 requires EPA to continually designate existing chemicals as “high-priority” based on factors including hazard and exposure potential.  Once a high priority designation is made, EPA is required to conduct a risk evaluation and regulate the chemical if it is found to present an unreasonable risk.

If the notice is finalized as proposed, EPA would immediately initiate risk evaluations for the following five substances:

  • Vinyl Chloride (CASRN 75-01-4)
  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • 4,4’-methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

According to an EPA press release, vinyl chloride is a known human carcinogen linked to liver, brain, and lung cancer in exposed workers.  In the release, EPA stated that vinyl chloride’s health hazards helped motivate the passage of TSCA in 1976.

The press release noted that the other four substances are probable human carcinogens and that some pose other types of hazards, such as respiratory and reproductive harms.  All five substances are used to make plastic; vinyl chloride is mostly used to make polyvinyl chloride, better known as PVC.

EPA announced that it was beginning the process of prioritizing these chemicals in December 2023.  In that announcement, EPA also stated that that it “expects to initiate prioritization on five chemicals every year, which will create a sustainable and effective pace for risk evaluations.”

Comments on the notice are due October 23, 2024.

EPA Proposes to Request Unpublished Studies for 16 Chemicals

/in , ,

On March 26, 2024, EPA published a proposed rule that would require manufacturers of sixteen chemical substances to submit a wide breadth of unpublished studies to the Agency.

If finalized, the rule would amend the list of chemicals subject to health and safety reporting located at 40 CFR 716.120 by adding the following:

  • 4,4-Methylene bis(2-chloraniline) (CASRN 101–14–4)
  • 4-tert-octylphenol(4-(1,1,3,3- Tetramethylbutyl)-phenol) (CASRN140– 66–9)
  • Acetaldehyde (CASRN75–07–0)
  • Acrylonitrile (CASRN 107–13–1)
  • Benzenamine (CASRN 62–53–3)
  • Benzene (CASRN 71–43–2)
  • Bisphenol A (CASRN 80–05–7)
  • Ethylbenzene (CASRN 100–41–4)
  • Naphthalene (CASRN 91–20–3)
  • Vinyl Chloride (CASRN 75–01–4)
  • Styrene (CASRN 100–42–5)
  • Tribomomethane (Bromoform) (CASRN 75–25–2)
  • Triglycidyl isocyanurate; (CASRN 2451–62–9)
  • Hydrogen fluoride (CARN 7664– 39–3)
  • N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD) (CASRN 793– 24–8)
  • 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428–18– 5).

EPA proposed to prioritize five of the listed chemicals (underlined above) for TSCA section 6 risk evaluation in December 2023.  The proposed rule also includes 10 chemicals EPA is considering including in its December 2024 initiation of prioritization.  The last substance, a 6PPD transformation product, was included as a result of EPA’s decision to grant a citizen’s petition on 6PPD.

Pursuant to 40 CFR 716.10 and 716.50, the requested information would include studies on health and safety, environmental effects, physical-chemical properties, exposure, and degradation.  Copies of unpublished studies, lists of known unpublished studies not in the submitter’s possession, and lists of ongoing studies would all be required.  Copies of each study previously listed as ongoing would also be required upon completion, regardless of the study’s completion date.

Studies previously submitted to EPA pursuant to a requirement under TSCA would be exempted from the request.  However, EPA proposes not to apply the typical exemption for persons manufacturing one of the 16 substances only as an impurity.

In addition to current manufacturers (including importers), persons who have manufactured or proposed to manufacture a listed substance within the past ten years would be required to submit the requested information.  Comments on the proposed rule are due on May 28, 2024.

DuPont De Nemours Inc. Sues EPA Regarding GenX Test Order

/in ,

Earlier this year, the US Court of Appeal for the Third Circuit ordered EPA to provide documentation regarding the Agency’s decision to order DuPont De Nemours Inc. to provide information on GenX chemicals through two section 4 test orders under the Toxic Substances Control Act (TSCA). DuPont brought this case to challenge the testing requirements imposed on the company, asserting that EPA had incorrectly identified the company as a manufacturer of the chemicals identified in the test orders:  hexafluoropropylene oxide (also known as trifluoro(trifluoromethyl)oxirane) and 6:2 Fluorotelomer sulfonamide betaine, two GenX chemicals. The test orders required testing on the inhalation effects toxicity of the chemicals in order to enable EPA to further understand protentional risks posed to human health and the environment. In addition to the cost of the toxicity studies, the manufacturers subject to the orders were assessed a fee of $11,650 to be split evenly amongst them.

After receiving the order to provide documentation, EPA requested several time extensions, but eventually stipulated to an agreement dismissing the case. The motion filed in May 2023 released DuPont from the test orders on 6:2 fluorotelomer sulfonamide betaine and hexafluoropropylene oxide. The Court then dismissed the case.