The Academy of Toxicological Sciences (ATS) has recently announced newly elected Board and Committee Members, including two Gradient scientists. Gradient’s Dr. Julie E. Goodman was elected Vice President, and Dr. Tom Lewandowski was elected to the Awards Committee.
ATS is a leading international organization that certifies toxicologists by peer review of education, professional experience, leadership, and demonstrated achievement and scientific expertise. This organization forms a professional community of toxicologists recognized by their peers for their expertise and sound scientific judgment in toxicology.
Julie E. Goodman, Ph.D., DABT, FACE, ATS is an epidemiologist and board-certified toxicologist with expertise evaluating human health risks associated with chemical exposures in a variety of contexts, including products, foods, and medical applications.
Tom Lewandowski, Ph.D., DABT, ERT, ATS is a toxicologist and chemist with experience in the areas of product safety evaluation, pharmacokinetics, metals toxicology, and developmental toxicology.
Keywords: Gradient, Julie E. Goodman, Tom Lewandowski, Toxicology, Certified Toxicologists, The Academy of Toxicological Sciences (ATS)
In this issue of Trends, we provide several articles on the topic of medical device safety.
Our first article provides an overview of recent updates to the International Organization for Standardization (ISO) 10993-1 standard and their far-reaching implications. ISO 10993-1 is the international standard guiding the evaluation of medical device biocompatibility. The second article explores a screening approach to identify and mitigate potential health risks from medical device extractables. The third article discusses the importance of choosing an appropriate analytical method when assessing chemical “extractables” in medical devices. Our fourth article is co-written by Kelly Coleman of Medtronic and takes a closer look at how the newly released ISO 10993-1:2025 standard is redefining the assessment of “material-mediated pyrogenicity” (i.e., the ability to produce a febrile/fever response) in medical devices, including by significantly reducing animal testing.
Gradient contributors to this Trends issue include Daysi Diaz-Diestra, Ph.D., DABT; Lindsey Borton, M.P.H., DABT; Stephanie Kearing, M.S.; Katie Roach, Ph.D., M.P.H., DABT; and Brigitte Cronin.
Articles:
Gradient announces the exciting news that Lindsey Borton and Kelly Coleman are finalists for the 2026 Lush Prize for their work using a science-based approach to show shortcomings of the rabbit pyrogen test (RPT) for the detection of material-mediated pyrogens (MMPs), and for support of alternatives to animal-based testing.
Read the article: Borton, L; Coleman, K. 2025. “Material-mediated pyrogens in medical devices: Myth or reality?” ALTEX – Altern. Anim. Ex. doi: 10.14573/altex.2504231.
In this article, Gradient Principal Toxicologist Lindsey Borton and Medtronic Sr. Distinguished Toxicologist Kelly Coleman used an evidence-based toxicology approach to determine whether MMPs exist in a medical device context, and whether the RPT could detect the presence of MMPs in or on a medical device. The implications have potential to reduce animal-based testing requirements. See more
The Lush Prize supports initiatives to end or replace animal use in research, testing, and education.
Congratulations to Lindsey Borton and Kelly Coleman and to all of the finalists on the 2026 Lush Prize shortlist!
Gradient Senior Environmental Chemist Dr. Amy Hrdina will be presenting at the American Geophysical Union (AGU) 2025 annual meeting, taking place December 15-19, 2025 in New Orleans, LA.
Gradient Principal Dr. Joel Cohen has been accepted as a Fellow of the Academy of Toxicological Sciences (ATS).
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.
Congratulations, Joel!
Ms. Lindsey Borton and Drs. Cassandra Meakin, Nicole Olgun, and Katherine Roach have been certified as Diplomates of the American Board of Toxicology (DABT).
The American Board of Toxicology (ABT) established the certification process to “evaluate and document competency in the field of toxicology.”
“ABT Diplomates participate in all aspects of the profession of toxicology including: the design and interpretation of safety studies for product development; review and interpretation of such studies for regulatory compliance; basic and applied research into toxic effects, mechanisms of toxic action, toxicokinetics and toxicodynamics; and education of undergraduates, professional and graduate students and the public in the science of toxicology through courses, legal cases and media interactions.”
Congratulations, Lindsey, Cassie, Nicole and Katie!
Gradient is presenting at the 2025 Society for Risk Analysis (SRA) Annual Meeting, taking place December 7-10, 2025, in Washington, DC.
Gradient is presenting at the ACT 2025 Annual Meeting, taking place November 16-19, 2025, in Phoenix, Arizona.
Gradient Poster Presentations:
“A Risk-Based Material Characterization Framework for Shelf-Life and Change Management in Medical Devices”
Daysi M. Diaz-Diestra, Alex Gauthier
“Umbrella Review of Systematic Reviews and Meta-analyses of GLP-1RA Treatment and Risk of Thyroid and Pancreatic Cancers”
Manoochehr Khazaee, Denali Boon, Katherine Roach, Isaac Mohar, Alex Gauthier
“Multi-Target GLP-1RAs and ICH S1B(R1): Is the 2-Year Rat Study Still Necessary?”
Katherine Roach, Alex Gauthier, Manoochehr Khazaee, Isaac Mohar
Gradient is presenting at the SETAC North America 46th Annual Meeting, taking place November 16-20, 2025, in Portland, Oregon.
Gradient Presentations:
“4.10.A.T-05 Sediment Dating in Environmental Investigations: A Review”
Jessie Kneeland, Gradient
Wednesday, November 19, 2025
11:20 AM
Oregon Ballroom 202 (Level 2, OCC)
“8.03.T-03 Challenges and New Approaches in Conducting Alternatives Assessment for 6PPD in Motor Vehicle Tires”
Thomas Lewandowski, Gradient
Thursday, November 20, 2025
2:10 PM
Oregon Ballroom 202 (Level 2, OCC)
Gradient Poster Presentations:
“5.12.P-Th-111 Human Heath, Environmental, Physicochemical and Regulatory Information for Amine Solvents, Degradation Products, and Impurities Associated With Post-Combustion CO2 Capture: A Screening Assessment”
Ari Lewis1, Tatiana Manidis1, Robert Trautz2, Annette Rohr2 and Abhoyjit Bhown2, (1)Gradient, (2)EPRI
On November 10, 2025, the United States Environmental Protection Agency (US EPA) released a pre-publication notice regarding the proposed changes to the Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Data Reporting and Recordkeeping Rule Under the Toxic Substances Control Act (TSCA) [TSCA section 8(a)(7)]. The proposed changes seek to preserve essential PFAS data collection, while adding certain exemptions to ease compliance for companies. Read the US EPA press release here. Major proposed changes are summarized in Table 1 below.
Table 1 Proposed Changes to the PFAS Reporting Rule Under TSCA
Notes: CAS = Chemical Abstracts Service; CDX = Central Data Exchange; No. = Number; PFAS = Perfluoroalkyl and Polyfluoroalkyl Substances; TSCA = Toxic Substances Control Act; US EPA = United States Environmental Protection Agency.
Once the proposed rule is published in the Federal Register, US EPA will seek public comments on the proposed changes for 45 days in docket #EPA-HQ-OPPT-2020-0549.
Next Steps:
1. Stakeholders are encouraged to provide comments to US EPA on the proposed rule.
2. Companies should evaluate the potential implications of the proposed rule to their portfolio and get ready for reporting by summer of 2026.
Contact Gradient scientists for support on PFAS reporting under TSCA and for US states, including Minnesota and New Mexico.
Contacts: