US EPA Proposes to Extend TSCA PFAS Reporting Deadlines by Eight Months (January 11, 2026)

See Announcement: Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Change to Submission Period and Technical Correction

Citing funding difficulties delaying the development of the Toxic Substances Control Act (TSCA) section 8(a)(7) CDX reporting tool, the US Environmental Protection Agency (US EPA) is taking direct final action to change the start of the reporting period and reporting deadlines by eight months.  This change, published September 5, 2024, will become effective in 60 days, unless US EPA receives adverse comments within the next 30 days.

Deadlines:

Beginning of Data Submission
November 12, 2024 (original); July 11, 2025 (amended)

End of Data Submission
May 8, 2025 (original); January 11, 2026 (amended)

End of Data Submission for Small Business, Article Importers
November 10, 2025 (original); July 11, 2026 (amended)

US EPA has also amended the requirement for submittal of environmental and health effects information in Organization for Economic Cooperation and Development Harmonised Templates (OHTs) for Reporting Test Summaries format from “each published study report” to “each unpublished study report.”  Submittal of environmental and health effects information is only required for substances and mixtures, not for imported articles.

Link to the announcement in the Federal Register can be found here:  Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Under the Toxic Substances Control Act (TSCA); Change to Submission Period and Technical Correction

Gradient Experts:

Chase H. Butler, M.S.
Senior Environmental Chemist

Ari S. Lewis, M.S.
Principal

Caroline B. Tuit, Ph.D.
Principal

Jiaru Zhang, M.P.H., DABT
Principal Scientist

The California Department of Toxic Substances Control (DTSC) recently issued a notice of compliance approving the Preliminary Alternatives Analysis (AA) for motor vehicle tires containing the antiozonant N-(1,3-dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD), which was co-authored by Gradient scientists.  6PPD is an antiozonant used in motor vehicle tires sold worldwide and is critical to their safe use and longevity.  Starting in 2021, scientific studies reported that a degradation product of 6PPD, found in tire and road wear particles, can cause pre-spawn mortality in certain sensitive fish species, particularly coho salmon native to the West Coast of the United States (US).  The mechanism for this toxicity is currently unknown.  At the request of the U.S. Tire Manufacturers Association (USTMA), DTSC listed motor vehicle tires containing 6PPD as a Priority Product under the Safer Consumer Products (SCP) program to facilitate the search for an acceptable 6PPD alternative.  Over 70 candidate alternatives were evaluated in this robust process.  As a result of the Stage 1 AA process, Gradient scientists identified seven possible 6PPD alternatives that warrant a deeper evaluation in terms of their performance and health effects:

• N-(1,4-dimethylpentyl)-N’-phenyl-p-phenylenediamine (7PPD)
• N-Isopropyl-N’-phenyl-1,4-phenylenediamine (IPPD)
• N,N’-Bis(1,4-dimethylpentyl)-p-phenylenediamine (77PD)
• N,N’-Dicyclohexyl-4-phenylenediamine (CCPD)
• A specialized form of graphene
• Octyl gallate
• 4,6-bis(octylthiomethyl)-o-cresol (Irganox 1520)

The seven possible alternatives will now be evaluated in Stage 2, with the goal of identifying at least one replacement chemical with a better hazard profile and acceptable performance within two years.  As part of the process, USTMA and Gradient scientists had detailed conversations with DTSC staff to help ensure that the submitted Preliminary AA could be approved by DTSC within the 30-day final review period.  The Preliminary AA for 6PPD represents the third successful AA Gradient has prepared under the SCP program.

Gradient’s work was carried out on behalf of a global consortium of tire manufacturers mobilized by USTMA.  A copy of the approved Preliminary AA is available on the USTMA website.

Gradient Experts:

Tom Lewandowski, Ph.D., DABT, ERT, ATS
Principal
Tom.Lewandowski@gradientcorp.com

Jiaru Zhang, M.P.H., DABT
Principal Scientist
Jiaru.Zhang@gradientcorp.com

Gradient Senior Epidemiologist Dr. Denali Boon will be presenting at the 36th Annual Conference of the International Society for Environmental Epidemiology (ISEE), August 25-28, 2024 in Santiago, Chile.

• “The Impact of Recall Bias on the Association Between Talc and Ovarian Cancer in Case-Control Studies.” D. Boon, L. Espira, J. Goodman

Gradient will exhibit at MEDevice Boston September 25-26, 2024, in booth number 523 (Exhibit Level Hall C).

Our team will co-present with Eurofins EAG Laboratories in the MEDevice Tech Theater at 10:30am ET on September 25.

Presentation Title: Biocompatibility Strategies for Saving Cost and Time When Making a Change to Your Device

Abstract: Material supplier and specification changes during initial and re-assessment of design verification biocompatibility activities can present an additional hurdle for manufacturers, which can result in costly and time-consuming retesting. In this presentation, we discuss how to evaluate biocompatibility material equivalence through leveraging physical and chemical characterization strategies. We incorporate ISO 10993-19 physical, morphological, and topographical (PMT) characterization to reduce the burden of retesting while ensuring enough information to evaluate device safety. Further, we will explain approaches leveraging targeted chemical characterization for equivalency and toxicological risk assessment of extractable chemicals.

Speakers include Drs. Alex Gauthier and Joel Cohen from Gradient and Drs. Todd Stark and Saheel Bhana from Eurofins EAG Laboratories.

View more information about our joint presentation or contact us to learn more about medical device services.

Gradient Senior Environmental Chemist Dr. Amy Hrdina will be presenting at the American Chemical Society (ACS) Fall 2024 conference, August 18-22, 2024 in Denver, CO & Hybrid.

• “Considerations when using the integrated horizontal flux method to evaluate volatility in pesticide product registration.” A. Hrdina, A. Low, C. DesAutels

Studies Evaluate “Real-Life” Exposures to Micro- and Nanoplastics (MNPs) Associated with Consumer Products

Micro- and nanoplastics (MNPs), i.e., plastic particles less than 5 millimeters and 1 micrometer in size, respectively, are ubiquitous in the environment and can be added intentionally to, or generated inadvertently by, a broad range of consumer products. In a June webinar, the European Commission-funded Research Cluster to Understand the Health Impacts of Micro- and Nanoplastics (CUSP) presented initial findings from two of its ongoing research projects: 1) the POLYRISK project and 2) the “Actionable eUropean ROadmap for early-life health Risk Assessment of micro- and nanoplastics” (AURORA) project. These studies are notable because they are some of the first to measure “real-life” consumer, environmental, and occupational exposures to MNPs in humans and evaluate potential health outcomes.

The POLYRISK project is evaluating effects on the immune system (e.g., inflammation) associated with MNPs as part of five “real-life” exposures:

1. Volunteers exposed for four hours at a busy road, an urban park, or a crossroad;
2.  Workers in a textile factory;

3.  Workers in a tire refurbishment factory;

4.  Volunteers playing indoor soccer on artificial turf with or without rubber granulates; and

5.  Eight different brands of bottled drinking water for sale in Norway.

According to the lead researcher of the POLYRISK project, Dr Hubert Dirven, the bottled drinking water study was terminated because the detected levels of MNPs greater than 1 micrometer in size were “so low that we thought it would not make any sense to do the study.” For the other POLYRISK studies, measurement of MNP levels in air samples and blood samples of volunteers is ongoing, as well as evaluation of markers of immune function in blood. The POLYRISK project will be completed in 2025.

The AURORA project focuses on early-life exposures to MNPs and associated effects on fetal growth and health outcomes in children. The researchers are analyzing MNP levels in over 800 historical samples of placenta and cord blood collected from subjects in a birth cohort in Spain. The study is also assessing placental function (i.e., placental blood flow) and molecular markers of inflammation, antioxidant response, and endocrine function. Since the enrolled children are now 12 years old, the researchers are evaluating child health outcomes. The researchers hope to complete collection of exposure data in 2024, and complete the project in 2026.

Overall, the CUSP research efforts seek to advance the understanding of potential effects associated with MNPs on human health, and develop a framework for risk assessment of MNPs. As noted by CUSP in its policy brief published in April 2024, MNPs are “a reasonable concern” for public health; however, “the health risks remain unclear and the hazards, exposures and risks of individual types of plastics and their specific chemical additives still need to be determined.”

The CUSP webinar recording and presentation slides are available here. If you have any questions, please contact:

Andrew Yeh, Ph.D., DABT
Senior Toxicologist

Jiaru Zhang, M.P.H., DABT
Principal Scientist/Toxicologist

Matt Tymchak, M.S.
Senior Hydrologist

Gradient will present at the Utility Solid Waste Activities Group (USWAG) 10th Annual CCR Workshop.  June 17-19, 2024. Nashville, TN.

Gradient will present at Battelle’s Chlorinated 2024 Conference.  June 2-6, 2024. Denver, CO.

• “Domestic Wastewater as a Potential Non-Point Source of PFAS Contamination in North America.” Patricia Clyde, Renee Hebert, Kathryn Zic, and James Rice.

The California Department of Toxic Substances Control draft 2024-2026 work plan continues to identify and updates broad product categories the agency will consider for potential Priority Products, and requires manufacturers of Priority Products to conduct alternatives analyses.

At the end of May, the California Department of Toxic Substances Control (DTSC) released a draft 2024-2026 Priority Product Work Plan for the Safer Consumer Products (SCP) program. The SCP program requires manufacturers of listed products (“Priority Products”) to conduct an alternatives analysis to determine whether safer product chemistries or designs are feasible. The draft work plan identifies broad product categories that DTSC will research and consider for potential Priority Products over the next few years. Note that these categories are not Priority Products and do not require any regulatory response until a specific Priority Product is identified and listed formally. Regardless, the draft work plan serves as notice that these product categories are on the DTSC’s radar, and manufacturers of these products are advised to monitor DTSC’s CalSAFER website for developments and opportunities to provide comment prior to product listing. Similarly, manufacturers of these products should review DTSC’s questions on the draft work plan and provide answers, if interested. Seven product categories will be the focus of DTSC’s efforts under the draft work plan, several of which have been carried forward from the 2020-2023 Work Plan. In addition, where work is already underway, DTSC indicates upcoming activities towards product listing. The seven categories are:

• Beauty, Personal Care, and Hygiene Products – DTSC is developing a Priority Product profile to list sodium hydroxide in hair straightening products as a Priority Product.
• Cleaning Products – DTSC plans to release documents in the next few months that will support future rulemaking concerning 1,4-dioxane in personal care and cleaning products. The agency also notes that laundry detergents containing nonylphenol ethoxylates are already in the process for listing as a Priority Product.
• Building Products and Materials Used in Construction and Renovation – Artificial turf and engineered stone are mentioned specifically as topics of interest.
• Children’s Products (two categories) – Phthalates, formaldehyde, styrene, bisphenols, and parabens are noted as chemicals of interest.
• Paints (new, formerly part of building products) – DTSC has created a specific category for paints to highlight its intention to evaluate these products, focusing particularly on per- and polyfluoroalkyl substances (PFAS) and microplastics in paints.
• Products That Contain or Generate Microplastics (new) – DTSC is in the process of adding product(s) that generate microplastics to the Candidate Chemicals list. It is not clear which product(s) DTSC will select; however, the draft work plan mentions potential products such as plastic packaging, synthetic clothing and textiles, cigarette filters, tires, and paints.

In addition, DTSC has indicated that it will begin researching several other product categories as resources allow, including:

• Food packaging;
• Motor vehicle parts, accessories, maintenance, and repair materials;
• Electronics, with a particular interest in PFAS and flame retardants;
• Products used or produced by metal plating and finishing facilities;
• Pet care products; and
• Sporting and athletic equipment.

Further, DTSC notes that in the Motor Vehicle Parts category, the designation of motor vehicle tires containing zinc as a Priority Product is expected to start in 2024. DTSC has already designated motor vehicle tires containing the antiozonant 6PPD as a Priority Product and it is unclear how these two efforts will interact.

Moreover, two notable changes in the SCP program are mentioned briefly in the draft work plan:

• California’s Senate Bill (SB) 502 provided DTSC enhanced authority to require manufacturers to submit available data on product chemical composition, consumer use, and sales. Failure to do so can result in administrative or civil penalties.
• Under SB 502, DTSC also was given the authority to move directly to regulatory response instead of requiring manufacturers to conduct an alternative analysis. In this case, DTSC will use publicly available studies or existing evaluations of alternatives. How DTSC will assess whether existing analyses meet all the requirements of the regulation remains to be seen.

Regarding the draft work plan, rather than accepting general comments, DTSC has developed nine specific questions to which experts and members of the public are invited to submit answers by July 1, 2024, via CalSAFER. In addition, DTSC will be hosting a virtual workshop to review the draft work plan and receive comments on June 18, 2024.

A copy of the draft three-year work plan is available here. If you have any questions, please contact:

Tom Lewandowski, Ph.D., DABT, ERT, ATS
Principal
tlewandowski@gradientcorp.com

Jiaru Zhang, M.P.H., DABT
Principal Scientist
jzhang@gradientcorp.com

Gradient Hosting Webinar on ISO 18562:2024 – Chemical and Toxicological Strategies

Webinar Date:  Tuesday, June 25 • 1:00-2:00 PM (EST)

Register here

Join Gradient biocompatibility experts, Drs. Alex Gauthier and Rachel Chang, and special guest speaker Corey Campbell, from Legend Technical Services, Inc., in a free webinar that will provide an “Overview of ISO 18562:2024 – Chemical and Toxicological Strategies.”  Recent updates to the ISO 18562 series of standards introduce major changes to the chemical, biological, and toxicological evaluation of gas pathway devices (e.g., ventilators, anesthesia workstations, breathing systems).  This webinar will provide insights on key ISO 18562-1, -2, -3, and -4 standards and their resulting impacts on biocompatibility and related testing strategies.  Topics include:

• Preparing biological evaluation plans and reports for gas pathway medical devices;
• Designing testing strategies for evaluating potential patient exposures to particulate matter (ISO 18562-2), volatile organic substances (ISO 18562-3), and leachables in condensate (ISO 18562-4); and
• Conducting toxicological risk assessment of extractables and leachables, and assessment of particulate matter and volatile gas substances.

Alex G. Gauthier, Ph.D., is a Senior Toxicologist at Gradient who specializes in medical device biocompatibility, toxicological risk assessment, pharmaceutical non-clinical safety assessment, and large animal safety and efficacy studies.

Rachel Chang, Ph.D., DABT, is a Senior Toxicologist at Gradient with expertise in human health risk assessment and developmental toxicology.  She focuses primarily on toxicological risk assessment of extractables and leachables from medical devices, safety assessments of consumer products, and benchmark dose modeling.

Corey Campbell, CHMM, is an Industrial Hygienist at Legend Technical Services, Inc., who conducts design/set-up and testing of medical devices for any contribution of volatile organic compounds, PM_2.5/PM₁₀ particulate, and inorganic gases (carbon dioxide, carbon monoxide and ozone).

Register here