Gradient Principal Scientist Dr. Isaac Mohar will be presenting at the Pharm Ed Resources, Inc. Extractables & Leachables West 2023 conference, November 2-3, 2023 in La Jolla, CA.

• “Use of Toxicological Screen Limit (TSL) in Medical Device ISO 10993-17:2023 Risk Assessments.” I. Mohar

The Environmental Business Council (EBC) of New England announced that Hilary Robinson, PE, has joined the Leadership Team of the EBC Emerging Contaminants Working Group.

The members of the EBC Emerging Contaminants Working Group Leadership Team help to identify programming for EBC events.  Read more about the position, here.

The European Commission updated the Classification, Labelling and Packaging (CLP) Regulation on March 31, 2023, with the following hazard classes (link):

• Endocrine disruptors (ED) for human health or the environment;
• Persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB); and
• Persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM).

These new hazard classes for CLP of substances and mixtures were adopted on April 20, 2023. New substances on the market will need to be classified and labeled for these new CLP hazard classes by May 1, 2025, and new mixtures by May 1, 2026. Although the specific criteria for the new classifications have not been finalized, draft guidance with important details on the proposed classification scheme was released last month (link).

Complying with these new CLP hazard classes will require considerable effort and resources. Gradient scientists Dr. Tim Verslycke and Ms. Ari Lewis recently presented at PSX 2023 and PCPC 2023 on the likely impact of the new endocrine disruption classes and described a structured approach for screening ingredient portfolios to identify priorities, data gaps, and plan resources informed by prior project work on this topic. If you missed these talks or are interested in discussing further, please reach out.

To learn more about Gradient’s process for portfolio screening against the new CLP hazard classes or to have Gradient present to your company on this topic, please contact:

Tim Verslycke, Ph.D.
Principal
tverslycke@gradientcorp.com

Ari Lewis, M.S.
Principal
alewis@gradientcorp.com

Gradient will be presenting at the American College of Toxicology’s 44th Annual Meeting, November 12-15, 2023 in Orlando, FL.

• “Toxicological Risk Assessment and Exposure Limit Derivation for Human Transferrin as a Serum-Free Media Residual in Cell-Based Drug Products.” I. Mohar, T. Lewandowski

Kurt Herman, M.Eng., P.G. is a licensed Professional Geologist in Oregon.

Gradient will have four poster presentations at the SETAC North America 44^th Annual Meeting, taking place November 12-16, 2023, in Louisville, KY. Click the links below to view the poster abstracts.

Gradient’s 2023 SETAC Poster Presentations:

“1.06.P-Mo-006 – A Portfolio Screening and Prioritization Framework for Endocrine Disruption”
Tim Verslycke, Ari Lewis, Tatiana Manidis, Delina Lyon, Nicholas Synhaeve, George Hinkal, Leslie Saunders, Sergio Villalobos, Kat Colvin
Session 1.06: New Approach Methodologies, Enhanced Strategies and Best Practices for Identifying and Evaluating Endocrine System Adverse Effects
11/13/23 @ 8:00 am-9:00 am

“5.05.P-Tu-194 – Limitations of Using Quantitative Structure-Activity Relationship (QSAR) models to Predict Organic Carbon Water Partition Coefficient (Koc) for Complex Active Pharmaceutical Ingredients (APIs)”
Wasfia Hoque, Jeff Rominger, Tim Verslycke
Session 5.05: Pharmaceuticals in the Environment – A One Health Perspective – Part A
11/14/23 @ 8:00 am-9:00 am

“5.05.P-Tu-223 – Environmental Safety Assessment of Data-Poor Pharmaceuticals Using Read-Across”
Ifeoluwa Bamgbose, Janet Vo, Tim Verslycke
Session 5.05: Pharmaceuticals in the Environment – A One Health Perspective – Part A
11/14/23 @ 8:00 am-9:00 am

“4.13.P-Th-099 – Domestic Wastewater as a Nonpoint Source of PFAS Contamination in the US”
Patricia Clyde, Kathryn Zic, James Rice
Session 4.13: Identifying PFAS Sources Near and Far
11/16/23 @ 3:30 pm-4:30 pm

Gradient will be presenting at the BfR International Conference on Using Epidemiological Studies in Health Risk Assessments: Relevance, Reliability and Causality, November 9-10, 2023 in Berlin, Germany.

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

Gradient will be presenting at the Personal Care Product Council (PCPC)’s 2023 Science Symposium, October 24-25, 2023 in Arlington, VA.

• “Screening, Testing and Assessing Ingredient Portfolios for Endocrine Disruption.” T. Verslycke, A. Lewis

Gradient Principal Scientist Dr. Caroline Tuit will host a forum session at the 2023 Society for Chemical Hazard Communication Annual Meeting, October 3-5, 2023 in Arlington, VA.

•  “The Challenges of Finding and Mitigating PFAS in Supply Chain.” Hosted by Caroline Tuit, Bruce Calder (Claigan Environmental), and Evelyn Ritter (3E)

Gradient is presenting at PSX 2023, taking place October 17-19, 2023, in Boston, Massachusetts.  See presentation details below.

Gradient’s PSX 2023 Presentations:

“D2:  Challenges in Ingredient Disclosure Alignment and Supplier Communication”
Kim Reid, Ari Lewis (Moderator)
Express Session
Room:  Burroughs (Westin Boston Seaport)
10/17/23 @ 3:30 pm-4:00 pm

“I1:  Current Regulatory and Scientific Developments in Microplastics”
Andrew Yeh, Lisa Bailey, Adam Grossman (Praedicat, Inc.), Matthew Tymchak (Moderator)
Education Session
Room:  Burroughs (Westin Boston Seaport)
10/18/23 @ 11:00 am-12:00 pm

“J3:  Strategies for Evaluating Endocrine Disruption Potential Across Large Chemical Portfolios”
Ari Lewis, Tim Verslycke (Moderator)
Express Session
Room:  Harbor Ballroom (Westin Boston Seaport)
10/18/23 @ 1:30 am-2:30 pm