Gradient is presenting at the 2023 Annual Meeting of the Society of Toxicology, taking place March 19-23, 2023, in Nashville, Tennessee. See presentation details below, and click the links to view poster abstracts.
Gradient’s 2023 SOT Meeting Presentations:
“New Approach Methods for Toxicological Risk Assessment of Extractable Compounds from Biodegradable/Bioresorbable Medical Devices” (links to program agenda)
Joel Cohen
Workshop: Biocompatibility Assessment of Absorbable/Degradable Materials Employed in Medical Devices: Challenges, Pitfalls, and Emerging Testing Methods
3/20/23 @ 9:15 am-12:00 pm
“Updates to ISO 10993-17 for Medical Device Toxicological Risk Assessments: What You Need to Know” (links to program agenda)
Lindsey Borton
Exhibitor-Hosted Session
3/21/23 @ 10:30 am-11:30 am
“P183: Framework for In Silico Toxicity Screening of Novel Odorants”
Awarded Top 10 Abstracts for the Computational Toxicology Specialty Section!
Isaac Mohar, Brad Hansen, Destiny Mims, Joel Mainland
Session: Computational Toxicology II
3/21/23 @ 9:00 am-10:45 am
“P299: Ranking Surrogate Suitability for Read-Across of Medical Device Extractables: A Case Study of Irganox-Related Compounds”
Rachel Chang, Patricia Clyde, Pranav Mashankar, Joel Cohen
Session: Medical Devices
3/22/23 @ 10:45 am-12:30 pm
“P283: Comparison of Contrast Media Components with International Organization for Standardization (ISO) Standard Solvents to Determine Representative Patient Risk”
Cassandra Meakin, Ian Hadley, Lindsey Borton
Session: Medical Devices
3/22/23 @ 10:45 am-12:30 pm
“P241: Considerations in Evaluating Dermal Absorption of Per-and Polyfluoroalkyl Substances (PFAS)”
Andrew Yeh, Laura Kerper, Robyn Prueitt, Barbara Beck
Session: PFAS II
3/22/23 @ 10:45 am-12:30 pm
“P346: Challenges in Evaluating Risks from Lead Exposure”
Barbara Beck, Joel Cohen, Steven Boomhower, Charlotte Marsh
Session: Risk Assessment III
3/22/23 @ 2:30 pm-4:15 pm
Matthew J. Mayo, M.S., GISP, CPG, P.G. was re-elected as Vice Chair of the Lancaster, MA Zoning Board of Appeals.
Gradient announces five employees promoted to Principal and Principal Scientist.
Lisa A. Bailey, Ph.D. is promoted to Principal: Dr. Bailey has a practice in toxicology and human health risk assessment, including occupational exposures and risks.
Lindsey K. Borton, M.P.H. is promoted to Principal Scientist: Ms. Borton has a practice in biological evaluation and toxicological risk assessment of medical devices.
David G. Dodge, M.S., DABT, CIH is promoted to Principal: Mr. Dodge has a practice in industrial hygiene, toxicology, risk assessment, and historical state of knowledge.
Isaac Mohar, Ph.D., DABT is promoted to Principal Scientist: Dr. Mohar has a practice in pharmaceuticals, medical devices, and toxicology and risk assessment.
Jiaru Zhang, M.P.H., DABT is promoted to Principal Scientist: Ms. Zhang has a practice in product stewardship, toxicology, and medical devices.
Here is wishing them the best in their new leadership roles.
Gradient has five presentations at Battelle’s Eleventh International Conference on the Remediation and Management of Contaminated Sediments, taking place January 9-12, 2023, in Austin, Texas. Click the links below to view the presentation and poster abstracts.
Gradient’s 2023 Battelle Sediments Conference Presentations and Posters:
“A1.4. Where Science and Cost Apportionment Collide: Contaminant Loading from Upland Soils to Sediments”
Matthew Mayo, Jeffrey Rominger, Neal Grasso
Poster Session: A1. Innovative Characterization and Assessment Approaches
1/10/23 @ 5:45 pm-7:00 pm
“A3.20. Identifying Byproduct (Also Known as “Inadvertently Generated”) Polychlorinated Biphenyls in Waterbodies”
Jeffrey Rominger, Kurt Herman, Patricia Tcaciuc
Poster Session: A3. Contaminant Forensics
1/10/23 @ 5:45 pm-7:00 pm
“B8.51. Digitizing the Haystack: Streamlined Techniques to Pinpoint Potentially Responsible Parties”
Matthew Mayo, James Rice, Shuo Zhao
Poster Session: B8. Advanced Data Analysis and Decision Tools
1/11/23 @ 5:45 pm-7:00 pm
“C5.53. Identifying and Managing Uncertainty in Environmental Response Costs at Sediment Sites”
Kurt Herman, Maggie Pollock, Shuo Zhao, Naomi Slagowski, James Rice
Poster Session: C5. Remedy Cost Allocation Considerations and Alternative Financial Models
1/11/23 @ 5:45 pm-7:00 pm
“B8. Digitizing the Haystack: Streamlined Techniques to Pinpoint Potentially Responsible Parties”
Matthew Mayo, James Rice, Shuo Zhao
Platform Session: B8. Advanced Data Analysis and Decision Tools
1/12/23 @ 10:55 am-11:20 am
Kurt Herman, M.Eng., P.G. was appointed to serve on the Board of Health in the town of Concord, MA.
See website for Town of Concord.
December 2022
Gradient is pleased to announce that Tim Verslycke will serve as President of the International Board of Environmental Risk Assessors (IBERA) for 2023-2024.
Founded in 2021 by the Society of Environmental Toxicology and Chemistry (SETAC), IBERA is an independent, non-profit entity registered in Brussels, Belgium. IBERA promotes scientific progress in environmental risk assessment, encourages education and training, and established the first international certification program in environmental risk assessment.
As President, Dr. Verslycke will work with the other elected officers and Council members to implement the goals of the IBERA program in the coming two years. Dr. Verslycke is also one of the founding members of IBERA.
European Union Proposes to Add New Hazard Classes to its CLP Regulations for Endocrine Disrupting Chemicals
On September 20, the European Commission (EC) published a proposal to amend the European Union’s Classification, Labelling and Packaging (CLP) Regulation of substances and mixtures (EC No. 1272/2008), and sought stakeholder feedback on this proposed amendment by October 18. The proposal identified four new hazard categories for endocrine disrupting chemicals, including “known or presumed” (Category 1) and “suspected” (Category 2) endocrine disruptors for human health or the environment. The proposal also describes a range of criteria to be used for classification, and advocates for the use of a weight-of-evidence approach informed by expert judgment.
Given that the proposed new hazard categories have not been adopted under the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS), it is yet unclear how the EC proposal will impact GHS and other chemical regulations. Further, given a lack of technical guidance for the proposed CLP classifications, the type of endocrine-related data that should be used and how it will support classification decisions is currently uncertain.
Regardless of these uncertainties, it is clear that enactment of the EC’s proposal would result in significant impacts to businesses, such as reclassification and labeling of substances and mixtures containing endocrine disruptors, updates to safety data sheets, revised registrations, etc. Even if the CLP proposal is not enacted in its current form, it is critical for industry stakeholders to evaluate the impact of this proposal, or similar future regulatory proposals, on their products.
For more than two decades, Gradient scientists have been at the forefront of the topic of endocrine disrupting chemicals, including drafting technical documents to support the United States Environmental Protection Agency’s Endocrine Disruptor Screening Program, conducting weight-of-evidence reviews, overseeing product portfolio vulnerability assessments, and incorporating endocrine disruption into product stewardship programs. To discuss this issue further, please contact us (see the list below).
Gradient will be hosting a webinar in the near future to discuss the potential impact of the EC’s recent CLP proposal. This webinar will discuss recommended actions businesses can take, with examples from past and ongoing projects. Watch for more information on this webinar, which will be coming soon.
Topics: Endocrine Disruption, Hazard Categories, Safety Data Sheets, Chemical Registration
Contact:
Ari S. Lewis, M.S.
Principal
alewis@gradientcorp.com
Tim Verslycke, Ph.D.
Principal
tverslycke@gradientcorp.com
Ifeoluwa A. Bamgbose, M.S. passed the American Board of Toxicology examination to become a Diplomate of American Board of Toxicology (DABT).
Dr. Rachel Y. Chang passed the American Board of Toxicology examination to become a Diplomate of American Board of Toxicology (DABT).
Update on OELs in Development
Occupational exposure limits (OELs) are airborne concentrations of chemicals recommended as guidance or promulgated as regulatory exposure limits for the protection of worker health. Periodically, OEL-setting organizations develop new limits for chemicals that lack them and re-evaluate existing limits, which they either retain or revise. Below, we provide updates on the current work of the major OEL-setting organizations in the US.
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs)
ACGIH’s TLV-Chemical Substance (TLV-CS) Committee identifies chemicals and physical agents for which to develop or revise TLVs and places them on its “Under Study” list. Every year, the Committee issues proposed new or revised TLVs in the form of Notices of Intended Changes (NICs).
The Notices of Intended Changes Issued by ACGIH
Notes: STEL = Short-Term Exposure Limit. (a) Values are time-weighted averages (TWAs), unless otherwise noted.
In September 2022, ACGIH announced several changes to its TLV development process for 2023: the “Under Study” list will no longer be tiered, the Committee will be able to add chemicals to the list at any time, and comment periods for NICs will be offered twice per year, each lasting three months.
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs)
OSHA has not indicated that any PELs are currently in development.
National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limits (RELs)
Currently, NIOSH notes that RELs for two chemicals are “under development” – toluene diisocyanate and 1-bromopropane. However, NIOSH last updated the “Peer Review Agenda” information for these RELs in 2016.
Occupational Alliance for Risk Science (OARS) Workplace Environmental Exposure Levels (WEELs)
This year, the OARS WEEL Committee developed a new WEEL for difluoroethylene, (E)-1,2 (HFO-1132 [E]) (350 ppm). WEELs for dimethyl ether and triethylenetetramine (TETA) are currently in the public comment stage.
As part of OEL development, many OEL-setting organizations offer opportunities for organizations to provide comments and/or submit data or other information about chemicals as part of their OEL development processes. Gradient scientists understand occupational exposures and the studies upon which OELs are based; we can support clients who want to contribute to the OEL-setting process for chemicals of importance to them. We provide information, analysis, and advice on a wide range of occupational health and risk issues.
Contacts:
Lisa A. Bailey, Ph.D.
Principal Scientist
David G. Dodge, M.S., DABT, CIH
Principal Scientist
Julie C. Lemay, M.P.H.
Senior Environmental Health Scientist
Tom A. Lewandowski, Ph.D., DABT, ERT, ATS
Principal
Christopher M. Long, Sc.D., DABT
Principal