Uncategorized Archives

Talk Overview: “To assess chemical risks, information on exposure and hazards (toxicity) is needed. Traditionally, hazard data has often come in part from animal testing. A new paradigm is to rely on New Approach Methods (also called New Approach Methodologies or NAMs) to try to minimize animal-based toxicity testing. NAMs can include read-across, computational methods, in vitro testing, and exposure-based refinements of the chemical risk assessment. Regulatory risk assessments for chemicals used in the semiconductor industry in the United States (US) may include new chemical assessments under the US Environmental Protection Agency’s (US EPA’s) Pre-Manufacture Notice (PMN) process and US EPA’s existing chemical risk evaluations under the Toxic Substances Control Act (TSCA). Regulators and scientists alike are advocating for a greater reliance on NAMs in these risk assessments to reduce the burden of animal testing. At the same time, there is a desire for confidence that NAMs can adequately address the “reasonable risk” standard under TSCA. This talk will review the available NAMs and frameworks for selecting appropriate NAMs. We will highlight how NAMs might be used to complement or replace more traditional toxicity testing with a case study from the Onium Photoacid Generator (PAG) Consortium.”

Dr. Jessie Kneeland is an environmental consultant with a diverse scientific background, including expertise in environmental chemistry, oceanography, and climate science. At Gradient, she interprets chemical signatures to discern different sources of chemicals in the environment. She also helps companies understand potential environmental impacts of new chemicals. Her scientific interests focus on using chemical signatures to trace biological, chemical, and physical processes in the environment.

Ms. Chase Butler is a chemist with experience in designing sampling plans and testing protocols, assessing data quality, and interpreting data to support the fulfillment of various regulatory obligations. At Gradient, she has provided technical support for chemical registration and compliance in multiple geographic regions and countries and advises on the use of appropriate chemicals for read-across of toxicological data. Prior to joining Gradient, Ms. Butler conducted research at Yale’s Center for Conservation and Preservation, studying the compounds generated during the oxidation of contemporary materials used in art and art conservation.

Gradient Toxicologist Lindsey Borton has received the Best Published Paper Award from the Medical Device and Combination Product Specialty Section of the Society of Toxicology.

[March 26, 2026, Boston, MA] – Gradient announces that Principal Toxicologist Lindsey Borton and Medtronic Sr. Distinguished Toxicologist Kelly Coleman have been awarded Best Published Paper by the Medical Device and Combination Product Specialty Section of the Society of Toxicology. This award recognizes “outstanding contributions to the field of toxicology in the context of medical devices and combination products.” Ms. Borton and Dr. Coleman were presented the award at an evening reception during the SOT 65^th Annual Meeting and ToxExpo on March 23, 2026, in San Diego, California.

Ms. Borton and Dr. Coleman used an evidence-based toxicology approach to determine whether material-mediated pyrogens (MMPs) exist in a medical device context, and whether the rabbit pyrogen test (RPT) could detect the presence of material-mediated pyrogens (MMPs) in or on a medical device. The implications have potential to reduce animal-based testing requirements. Their work was published in the journal, Alternatives to Animal Experimentation (ALTEX).

Read the published paper in ALTEX: Borton, L; Coleman, K. 2025. “Material-mediated pyrogens in medical devices: Myth or reality?” ALTEX – Altern. Anim. Ex. doi: 10.14573/altex.2504231.

According to the Society of Toxicology Medical Device and Combination Product Specialty Section website, “The SOT Specialty Sections represent the breadth and diversity of the toxicological sciences by focusing on specific toxicological areas.” The Medical Device and Combination Product Specialty Section has a purpose of “providing an international forum where government, industry, and academic toxicologists can share state-of-the-art knowledge and develop new approaches for the evaluation of medical devices.”

Gradient Toxicologist Dr. Cassandra J. Meakin has received the Early Career Achievement Award from the Medical Device and Combination Products Specialty Section of the Society of Toxicology.

[March 26, 2026, Boston, MA] – Gradient announces that Dr. Cassandra J. Meakin has received the Early Career Achievement Award from the Medical Device and Combination Products Specialty Section (MDCPSS) of the Society of Toxicology (SOT). This award recognizes “the research accomplishments of young scientists in the early stages of their careers who have demonstrated excellence in toxicological research related to medical devices and/or combination products.” Dr. Meakin was presented the award at an evening reception during the SOT 65^th Annual Meeting and ToxExpo on March 23, 2026, in San Diego, California.

Egidio Tentori is now a licensed Professional Engineer (PE) in the state of New York.

BMC Pharmacology and Toxicology “explores all aspects of research related to chemically defined therapeutic and toxic agents…on a broad range of topics, including clinical, basic and computational pharmacology.”

See information about European Register of Toxicologists (ERT) from the EUROTOX website:

“The European Register of Toxicologists is a service of EUROTOX established in 1994. It constitutes a list of toxicologists who excel by high standards of education, skills, experience, and professional standing. The intention is to foster competence in practice and science and to provide to the public an authoritative source of information on toxicological competencies. Individuals who want to be registered and are found to comply with the requirements defined by EUROTOX and National Societies of Toxicology, and are accepted, are qualified to use the title EUROPEAN REGISTERED TOXICOLOGIST, ERT, with their name.”

“Case Studies Evaluating Neonatal Susceptibility to Chemical Exposures from Medical Devices and Implications for Toxicological Risk”
Joel Cohen
Workshop Session: Toxicological Risk Assessment of Medical Devices Used for Neonatal and Pediatric Populations
3/23/26 @ 3:35 pm-4:00 pm

“Product Stewardship “Speed Round”: Latest Updates on PFAS, Microplastics, Proposition 65 and More”
Gradient speakers: Tom Lewandowski, Michael Peterson, Jiaru Zhang
Guest speaker: Martha S. Sandy, M.P.H., Ph.D., Chief, Reproductive and Cancer Hazard Assessment Branch, California Office of Environmental Health Hazard Assessment (OEHHA)
Exhibitor-Hosted Session
Room 24A
3/24/26 @ 12:15 pm-1:15 pm

“Non-Animal, Risk-Based Strategies for Medical Device Biocompatibility Assessment”
Gradient speaker: Daysi Diaz-Diestra
Guest speakers: Beau Rollins, RM(NRM) CISS EO, Global Head of Biocompatibility, Convatec; Catherine Christensen, M.S., Senior Product Stewardship Specialist, Solventum
Exhibitor-Hosted Session
Room 24A
3/25/2026 @ 12:15 pm-1:15 pm

US EPA’s proposed rule would rescind the risk-based emission standards of the 2024 NESHAP for Ethylene Oxide and reopen core questions about ethylene oxide as a carcinogen.

The US Environmental Protection Agency (US EPA) proposed revocation of the 2024 National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide (EtO) would rescind the rule’s risk-based emission standards and relax key compliance requirements – reopening core questions about EtO as a carcinogen and the underlying science of the original rule. US EPA announced formal reconsideration of the 2024 NESHAP for Ethylene Oxide Commercial Sterilization Facilities (40 CFR Part 63, Subpart O). The 2024 rule significantly tightened EtO emission limits based on a second residual risk review under Clean Air Act (CAA) § 112(f)(2).

Central to the proposed rule are uncertainties associated with the 2016 IRIS Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide and, specifically, the carcinogenic potency value (i.e., inhalation unit risk estimate), which served as the basis for the 2024 NESHAP rule that narrowed emissions limits. US EPA’s proposed rule suggests that it may not be appropriate to rely on the 2016 EtO Integrated Risk Information System (IRIS) value in setting standards due to significant uncertainties. US EPA is seeking additional information to help understand exposure and toxicity, including, but not limited to, the following:

There will be a 45-day public comment period and a virtual public hearing 15 days after the proposed rule is published in the Federal Register. Comments may be submitted to Docket No. EPA-HQ-OAR-2019-0178.

Gradient has deep expertise in EtO toxicology, risk assessment, air transport modeling, and regulatory developments. We can assist clients with:

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.

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.