Gradient environmental engineer and GIS specialist Naomi Slagowski will be presenting on a panel at the Brownfield Coalition of the Northeast (BCONE) Northeast Sustainable Communities Workshop (NSCW) 2025 taking place September 17-18, 2025 in Schenectady, NY.
Gradient Senior Environmental Scientist Dr. Qian Zhang will be presenting at the 2025 American Center for Life Cycle Assessment (ACLCA) Conference taking place September 16-19, 2025 in Atlanta, GA.
Gradient is presenting at EUROTOX 2025, taking place September 14-17, 2025 in Athens, Greece.
In this issue of Trends, we provide several articles on the topic of food and beverages as it relates to chemical exposure and human health.
Our first article discusses nutritional epidemiology and its role in understanding the risks and benefits of food. The second article explores chemicals in food packaging and test methods to assess their potential migration. The third article takes a closer look at food warning labels and related regulations, and our fourth article provides an overview of recent efforts by the United States Food and Drug Administration (US FDA) to make changes to food safety standards.
Gradient contributors to this Trends issue include Drs. Julie Goodman, Denali Boon, Caroline Tuit, and Steven Boomhower, and Ari Lewis, M.S.
Articles:
Gradient is presenting at North American Biocompatibility Summit (NABS) 2025, taking place in Minneapolis, Minnesota on September 10, 2025.
Gradient Principal Scientist Dr. Steven Boomhower will be presenting on a panel at the 2025 Prop. 65 Annual Conference in San Francisco, CA on September 8, 2025.
Gradient is presenting at PSX 2025, taking place September 16-18, 2025, in Houston, Texas. See presentation details below.
Gradient’s PSX 2025 Presentations:
“1A: Navigating Consumer Product PFAS Regulations Across State Lines – Practical Strategies for Product Stewards”
Jiaru Zhang, Kim Reid, Shuo Zhao
Education Session
Room: Galleria II
9/16/25 @ 9:45 AM – 10:45 AM CDT
“7A: Lessons Learned from Conducting Alternative Analysis under California’s Safer Consumer Products Program”
Tom Lewandowski, Jiaru Zhang
Express Session
Room: Galleria II
9/17/25 @ 8:00 AM – 8:45 AM CDT
“18A: Microplastics – A Deep Dive on Health Effects Studies and Possible Mechanisms of Toxicity Relevant to Consumer Products”
Michael Peterson, Matthew Tymchak (Moderator)
Education Session
Room: Galleria II
9/18/25 @ 10:45 AM – 11:45 AM CDT
Gradient’s recent comments to California Department of Toxic Substances Control on SB 502 Mandated Framework Regulations Amendments were cited recently by Chemical Watch.
Read the Chemical Watch article here: Industry seeks more scientific rigour in California SCP proposal for streamlined action.
Chemical Watch, a publication that covers regulatory developments that impact chemicals in products, noted Gradient’s recent comments on SB 502 Mandated Framework Regulations Amendments in its article, “Industry seeks more scientific rigour in California [Safer Consumer Products] SCP proposal for streamlined action.” The article summarizes reactions to the June 6, 2025, proposal from California’s Department of Toxic Substances Control (DTSC), outlining DTSC’s proposal to “streamline” chemical safety evaluation by skipping the alternatives analysis (AA) process using publicly available studies or evaluations of alternatives in lieu of an AA. Gradient commented on the insufficiency of DTSC’s proposed criteria for such third-party alternative evaluations, stating the criteria are “not robust enough.” Gradient is cited further in the Chemical Watch article as stating that the proposal would create “a two-track system where the requirements for the regulated parties are specific and extensive, but the requirements the agency must meet are substantially weaker.”
As cited by Chemical Watch:
The [current SB502 program] requires a manufacturer of a priority product “to go through the full AA process, address over 100 relevant factors, [and] provide documentation and citation support for all assertions and assumptions,” Gradient said. By contrast, the proposal would retain that process for manufacturers, but allow the DTSC to “make a determination that an AA or study is ‘sufficient’ and ‘appropriate’ based on its own judgement.”
In the Chemical Watch article, Gradient goes on to outline that the DTSC should better define minimum criteria for existing analysis it uses to “address aspects like chemical hazard, exposure potential, performance, cost and availability, impacts across the full product lifecycle, and the effects of chemical degradation products.”
Announcing a new medical device publication:
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 publication, Gradient Principal Toxicologist Lindsey Borton and Medtronic Sr. Distinguished Toxicologist Kelly 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 MMPs in/on a medical device. The implications have potential to reduce animal-based testing requirements.
Annex G of ISO 10993-11 lists 24 substances that are allegedly MMPs in medical devices and recommends using RPT for their evaluation. The scientists aimed to evaluate whether the Annex G MMPs are actually pyrogenic. They also explored whether compounds released from medical devices (extractables) could exert a hyperthermic response through uncoupling of oxidative phosphorylation, and reported the results of a survey of RPT failures and their root causes.
In brief, the study found RPT to be inadequate for biological evaluation of medical devices and suggested that it could be replaced with more effective methods. The authors recommend replacing the term “material-mediated pyrogen” with the specific classifications of “biological pyrogen” and “chemical thermogen.” Chemical thermogens can be detected and addressed through: (1) hazard assessment and (2) chemical characterization and toxicological risk assessment. Biological pyrogens that operate through the cytokine pathway (e.g., fungi, yeast, viruses, parasites, bacteria, bacterial endotoxins) should be managed through manufacturing controls. If manufacturing controls are insufficient, the in vitro monocyte activation test (MAT) can address a broad spectrum of biological pyrogens.
It was concluded that RPT could be replaced with a human blood cell test that detects all types of biological pyrogens.
Publication: Borton, L; Coleman, K. 2025. “Material-mediated pyrogens in medical devices: Myth or reality?” ALTEX – Altern. Anim. Ex. doi: 10.14573/altex.2504231.
Gradient Principals Dr. Lisa Bailey, Dr. Robyn Prueitt, and Mr. Michael Peterson have been accepted as Fellows 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, Lisa, Robyn, and Mike!