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

May 15, 2024

In this issue of Trends, we provide several articles on emerging issues in toxicology.

Articles include:

• Artificial Intelligence and Toxicology
• Evolving Chemical Risk Evaluation and Management Under the Toxic Substances Control Act:  Trichloroethylene as an Example
• Potential Health Effects of Plastic Additives
• Gradient Joins Geosyntec Consultants, Expanding Client Service for Health and the Environment
• What’s New at Gradient

Gradient Presenting at World of Coal Ash (WOCA), May 13-16, 2024

”Evaluating Surface Impoundment Closure Alternatives Using Relative Impact Assessment – Two Case Study Examples”
Gradient Authors: Andrew Bittner and Qian Zhang

”Corrective Action Sustainability: Holistic Decision Support Tool”
Gradient Authors: John Kondziolka, Ari Lewis, and Andrew Bittner

Congratulations to Egidio Tentori!

Environmental Business Council New England (EBC) has announced Egidio F. Tentori, Ph.D., E.I.T. – Senior Environmental Engineer with Gradient has joined the Leadership Team as an Ascending Professional Representative. In this role, Egidio will provide the Working Group with insight into EBC’s Ascending Professionals community and Committee, as well as thought leadership on the Emerging Contaminants industry.

Learn more here: https://lnkd.in/eeB-wMGy

https://lnkd.in/guknDnz9

Gradient will be presenting “A Refined Read-Across Approach to Support Environmental Assessment of Data-Poor Pharmaceuticals” at SETAC Europe 34th Annual Meeting during May 5-9, 2024 in Seville, Spain.  Authors include:  Ifeoluwa A. Bamgbose, M.S., DABT, Janet Vo, and Tim Verslycke, Ph.D.

Dr. Julie Goodman has been elected to the Academy of Toxicological Sciences (ATS) Board of Directors.

The Academy of Toxicological Sciences (ATS) is a nonprofit organization that exists to certify toxicologists who are recognized by their peers for their expertise and sound scientific judgment.  The purpose of this recognition and certification is to ensure, through peer review of credentials, the competence and experience of professionals whose work affects public welfare.  Candidates for certification must have demonstrated evidence of knowledge of toxicology and active involvement in toxicological activities.  A Fellow of the Academy must have an exemplary record of professional accomplishment, as well as extensive evidence of recognition by peers of competency and sound scientific judgment in toxicology as reflected by appointment or election to councils, committees, etc.

Ari Lewis Invited to Serve on the US EPA Science Advisory Board Environmental Justice Science & Analysis Review Panel

The United States Environmental Protection Agency (US EPA) recently announced appointments to its Science Advisory Board (SAB) Environmental Justice Science & Analysis Review Panel (EJSARP).  The SAB EJSARP will review the US EPA’s revised Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (EJTG) and develop a self-initiated commentary outlining recommendations on advancing environmental justice science in rulemaking.  The EJTG provides broad guidance on how to assess adverse human health and environmental impacts of proposed rules on vulnerable and overburdened populations.  Gradient scientist Ari Lewis, M.S., was selected to serve as one of 21 SAB EJSARP panel members.

See a list of the SAB EJSARP members here.

US EPA established the SAB in 1978 under the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA).  The SAB is tasked with reviewing “the quality and relevance of the scientific and technical information being used by the EPA or proposed as the basis for Agency regulations.”  Members of SAB advisory panels are recognized leaders in their chosen fields with a demonstrated ability to examine and analyze environmental issues with objectivity and integrity.

Ari Lewis is a principal with expertise in toxicology and risk assessment.  She has applied her toxicology expertise across a wide range of chemical stewardship issues and is especially interested in environmental justice and cumulative risk assessment, which includes the consideration of risk from non-chemical stressors (i.e., social factors) in vulnerable populations.

Please join us in congratulating Ari Lewis on this noteworthy service appointment!