Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a two-day training on its high throughput toxicokinetic (HTTK) R package as part of its New Approach Methods (NAM) Training Program:

  • Day 1: Presentation and demo: Wednesday, November 8, 2023, 10 a.m. - 12 p.m. (EST); and
  • Day 2: Expert-led hands-on learning activity: Thursday, November 9, 2023, 10 a.m. - 12 p.m. (EST).

According to EPA, toxicokinetics (TK) provides a bridge between toxicity and exposure assessment by predicting tissue concentrations due to exposure. EPA notes that traditional TK methods can be resource intensive and require chemical-specific data. EPA states that its freely available HTTK R package uses data from in vitro high-throughput screening data sets, which can be used to fill data gaps in traditional TK methods.
 
EPA’s goal for the two-day training is to familiarize those engaged in chemical exposure assessment, including researchers, regulators, and health and environmental safety professionals, with EPA’s generic and open-source models and data for toxicokinetics, including reverse dosimetry and physiologically based pharmacokinetic (PBPK) modeling for internal dose calculation. The training will include an application-oriented presentation and demonstration (Day 1), as well as opportunities for participatory learning and engagement (Day 2).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. EPA states that read-across “is a commonly used data gap filling technique whereby endpoint information for one substance is used to predict the same endpoint for another substance, supported by structural or other feature similarities.” According to EPA, while read-across sometimes relies on subjective or expert judgement, use of the GenRA tool could provide more objective and reproducible read-across predictions. Specifically targeted for decision-makers, this training will provide:

  • A presentation overview of GenRA’s purpose and scope;
  • A demonstration of GenRA’s interface and navigation; and
  • Opportunities for participatory learning and engagement.

The virtual training will feature EPA’s Dr. Grace Patlewicz. The training will include a plenary presentation, small group discussions, and a chance to try out GenRA. EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.

This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.

This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second ECOTOXicology Knowledgebase (ECOTOX) virtual training on February 7, 2023. ECOTOX is a comprehensive, publicly available tool providing environmental toxicity data on aquatic life, terrestrial plants, and wildlife.  EPA states that the virtual training, which is specifically targeted for decision-makers, will provide:

  • An overview of the database content and function;
     
  • Application-oriented use case demonstrations; and
     
  • Opportunities for participatory learning and engagement.

According to EPA, the virtual training will be a live encore of the training offered in May 2022, presenting the same material and featuring expanded opportunity for live interaction in Session 2. Participants may register for one or both sessions; registration is free but required to attend each session.
 
Session 1 (Presentation and Questions and Answers (Q&A))
11:00 a.m.-12:30 p.m. (EST)
This session will provide an overview of the knowledgebase content and function with opportunities for participation and Q&A.
 
Session 2 (Breakout Sessions)
12:30-1:30 p.m. (EST)
This session will break participants into breakout groups to work on case study exercises in small groups, aided by facilitators.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 7, 2022, that the final video recording, slide deck, and case study worksheets from the CompTox Chemicals Dashboard virtual training are now available. EPA also announced that the Dashboard recently released a new version (v2.1.1). New features include:

  • A new link to an updated set of Help Pages containing new information;
  • Ability to visualize structures in Batch Search;
  • Ability to filter out chemicals that are structures;
  • Moving the chemistry-related data tabs under a single tab;
  • reCAPTCHA implementation to ensure continued functionality;
  • Updating the Production Volume data;
  • Updating the ADME > IVIVE table using the latest HTTK R-package v2.2.1 algorithm; and
  • Several bug fixes.

EPA suggests that if users do not see these updates to try clearing the cache.

The recordings and slides from the October 12-13, 2022, EPA New Approach Methods (NAM) Conference are available on the conference web page. Conference topics included:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

 

More reports from attendees at last week's sold out, three-day Sustainable Futures (SF) workshop, co-sponsored by the Biobased and Renewable Products Advocacy Group (BRAG®), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU):


"I would highly recommend SF training to others. The risk-screening models are a great tool that can be utilized to identify and reduce risk early in the product development process. The instructors at the workshop were thorough and made themselves available to answer all questions." -- Ed Troche, Regulatory Specialist, Nalco


"Why not learn to screen your chemicals? That's the value of [SF Training] -- to identify challenges before your submit." -- Dale Strother, ToxSolve


"[The SF workshop] was well prepared, and certainly well presented. [It] offered a nice overview of the entire process of EPA's assessment of industrial chemicals. I was particularly enlightened as to where EPA chooses to be conservative in its industrial handling estimates." -- Robert W. Griffith, Nissan Chemical America Corporation


"The hands-on sessions are very helpful, walking through the models [was] much more efficient compared to exploring them on my own. The real scenarios are very relevant to some situations I will be working with so it's a great learning experience." -- Xinyu (Candy) Yang, Nalco


BRAG, an affiliate of Bergeson & Campbell, P.C. (B&C®) is in the early planning stages of a West Coast SF training workshop this Fall. If you would like to receive information regarding the next workshop, please e-mail Heidi Lewis and ask to be put on the list.
 


 

On August 5-7, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU) co-hosted a Sustainable Futures (SF) Training Workshop at GWU’s campus in Washington, D.C.


During the sold out, three-day workshop, participants learned about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals. The intensive, hands-on training allowed attendees to utilize the EPA methods of hazard and risk screening for human health, ecotoxicity, and environmental fate, and learn directly from EPA professionals how best to apply these tools.


With the intense training on EPA's computer-based models, attendees can now identify potential risks with chemical substances early in the commercial development process and reduce risk by finding safer substitutes and/or processes before submitting them to EPA under the Toxic Substances Control Act (TSCA) notification process. They can also better understand how EPA will review potential new chemical submissions -- and develop notifications that anticipate potential issues that, left unaddressed, could delay the notification process and commercialization.


Presenters included Kelly Mayo-Bean, Kendra Moran, and Dr. Yin-tak Woo from EPA's Office of Pollution Prevention and Toxics (OPPT), and Dr. Peter Ranslow of the Consortium for Environmental Risk Management (CERM).


BRAG and Bergeson & Campbell, P.C. (B&C®) are investigating opportunities for hosting additional training in the future, including sessions in California or other western regions.
 


 

Learn how to pre-screen new chemicals using EPA's models and methods during this hands-on, three-day workshop co-hosted by BRAG, EPA, and George Washington University (GWU) School of Law. You will learn about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals early in the development process and anticipate regulatory action before submitting the chemical to EPA for review. Sustainable Futures (SF) graduates can be eligible to receive reduced regulatory review time for dual Premanufacture Notification (PMN)/Test Market Exemption Application (TMEA) submissions. Presenters include Dr. Peter Ranslow (Consortium for Environmental Risk Management (CERM)) and EPA Office of Pollution Prevention and Toxics (OPPT) staff. For more information on SF and benefits afforded to workshop attendees, visit online. A flyer with full details is available online.