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
Gradient is pleased to announce that Chris DesAutels has joined the firm as a Principal Scientist. Chris is an air modeler with over 20 years of experience simulating the transport of air pollutants, conducting air quality modeling studies, and performing analyses of meteorological data. His experience covers a variety of applications and industry sectors, including transportation, agriculture, fugitive dust, odors, and dense gas releases. He has also been involved in air model software development and evaluation, including development work on the CALPUFF dispersion model.
In addition, Gradient welcomes Dr. Amy Hrdina who joins Gradient after completing a postdoc at Massachusetts Institute of Technology. Dr. Hrdina is an atmospheric chemist with a broad background in materials and analytical chemistry. She has conducted several field campaigns monitoring criteria pollutants, along with studying atmospheric ammonia and its role in secondary particle formation.
These additions to our team complement Gradient’s robust capabilities in exposure modeling and risk assessment. See more on Gradient’s Air Quality services.
NEWS ALERT
California’s New Safe Harbor Regulations Warn That Cannabis During Pregnancy Can Affect Child Birthweight, Behavior, and Learning Ability
As of October 1, 2022, California has adopted new safe harbor warnings for cannabis under Proposition 65. These warnings provide language on the potential adverse effects of prenatal cannabis exposure and may have implications for certain cannabis product manufacturers and businesses.
The California Office of Environmental Health Hazard Assessment (OEHHA) has issued new regulations regarding specific safe harbor exposure warnings, particularly during pregnancy. The regulations state that certain cannabis products and businesses need to include new safe harbor warning language in their labeling and/or signage in order to maintain compliance under California Proposition 65.
OEHHA’s new safe harbor warnings apply to cannabis products with the potential for exposure to cannabis smoke or delta-9-tetrahydrocannabinol (delta-9-THC) via inhalation, ingestion, or dermal application. Further, the new warnings apply to potential environmental exposures to cannabis smoke or delta-9-THC from businesses where delta-9-THC is smoked, vaped, or dabbed (i.e., inhaled in small quantities).
The new safe harbor warnings for cannabis are unique, as they include specific language regarding potential adverse effects from cannabis exposure during pregnancy. For example, to maintain compliance, cannabis products intended to be smoked need to warn consumers that the State has determined that smoking cannabis increases cancer risk and during pregnancy exposes a child to delta-9-THC and other chemicals that can affect the child’s birthweight, behavior, and learning ability. This updated language may reflect a change in OEHHA’s approach for labeling certain products under Proposition 65, where greater detail may be required in warnings. Further, OEHHA determined that use of the popular short-form warning for cannabis products is insufficient because it “does not provide the level of specificity needed for cannabis (marijuana) smoke and delta-9-THC exposures.” OEHHA continues, stating that the new safe harbor warning language “clearly conveys the adverse developmental effects cannabis smoke and delta-9-THC can cause when used by pregnant women.”
OEHHA allows for a one-year transition period for businesses to label their products with compliant warnings. OEHHA also states that businesses are free to substitute their own warning language for the agency’s wording; however, the use of OEHHA’s language is a defense against claims that other warning language does not meet the “clear and reasonable standard.” This suggests that certain businesses may risk non-compliance if they choose to develop their own safe harbor warning.
For more information, refer to OEHHA’s website and/or contact Gradient.
Topics: Cannabis, Delta-9-THC, Pregnancy, Proposition 65, Product and Consumer Safety
Contact:
Steven Boomhower, Ph.D.
Senior Toxicologist
sboomhower@gradientcorp.com
Tom Lewandowski, Ph.D., DABT, ERT, ATS
Principal
tlewandowski@gradientcorp.com
Kim Reynolds Reid
Principal Scientist
kreid@gradientcorp.com
James Rice, Ph.D.
Senior Environmental Scientist
jrice@gradientcorp.com