Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • 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.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 

Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995.

During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), Richard E. Engler, Ph.D., Director of Chemistry, B&C, and James W. Cox, M.S., Senior Scientist, B&C, discussed examples of EPA’s use and development of non-vertebrate testing strategies, successful collaborations between EPA and external partners to advance understanding and use of NAMs, and the need for EPA and stakeholders to approach implementation of NAMs with an “innovation mindset” that fulfills the requirements under TSCA. Lynn L. Bergeson, Managing Partner, B&C, moderated.

We encourage you to view the webinar, listen to the All Things Chemical® episode “Animal Testing and New TSCA,” and subscribe to B&C’s informative blogs and newsletters.

Tags: NAM, webinar

 

Wednesday, August 3, 2022
12:00 p.m. - 1:00 p.m. (EDT)

Register Today

The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”

These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:

  • Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
  • Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions; 
  • Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
  • Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.

Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH, as Bergeson & Campbell, P.C. (B&C®) presents “TSCA New Approach Methodologies.

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of EPA and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. He has participated in thousands of TSCA substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries.

James W. Cox, M.S., Senior Scientist, B&C, developed risk assessments and advised on hazard characterization processes under TSCA while working as Acting Lead Biologist in EPA’s OPPT New Chemicals Division. While at EPA, he helped develop a framework to complete risk assessments for novel petroleum alternatives and evaluated the hazard and risks to human health from exposure to industrial chemicals, biological agents, and nanomaterials.

Kristie Sullivan, MPH is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), a nationwide organization of physicians and laypersons that promotes preventive medicine and ethics in research. As Vice President of Research Policy, Ms. Sullivan directs PCRM’s efforts to promote human-relevant alternatives to the use of animals in medical research, education, and the testing of drugs, chemicals, and other products through scientific scholarship and outreach to companies, federal agencies, legislators, and others. Ms. Sullivan has 15 years’ experience in legislative, policy, science, and training activities related to the implementation of New Approach Methodologies, including by engaging with EPA, the Organization for Economic Cooperation and Development, and the regulated industry.

Register Now


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include:

  • Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon toxicity data generated from laboratory test species for the protection of wildlife in the environment. Typically, ecological risk assessments integrate safety factors to account for interspecies variability. According to EPA, the SeqAPASS tool is a more informed way to extrapolate knowledge from model species to other species that does not require the use of animals in toxicity testing and instead uses existing protein sequence knowledge. LaLone will describe EPA’s SeqAPASS tool and its applications for cross-species extrapolation relative to understanding conservation of biology and predicting chemical susceptibility.
     
  • Michael Lowit, Ph.D., EPA Office of Pesticide Programs (OPP), on “Exploring Potential Reductions in Fish Testing in a Regulatory Context.” According to EPA, as part of its commitment to reducing animal testing, OPP is conducting retrospective analyses of existing data to evaluate critically which EPA guideline studies form the basis of regulatory decisions. EPA states that the results from these analyses can inform if reductions can be made to the number of animals used without reducing the quality of ecological risk assessments. EPA is currently conducting a retrospective analysis for fish acute toxicity tests, which are used by OPP to assess potential risk to fish species from pesticides. For each pesticide, EPA typically requires in vivo testing of three different fish species. Lowit will focus on the relative sensitivity among species subjected to in vivo fish acute toxicity studies. The results of this analysis will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions.

The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers. Registration is now open.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
 
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 30, 2020, the U.S. Environmental Protection Agency (EPA) will hold a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List:  A Proposed NAM Nomination Form.”  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended Section 4(h)(2)(c) of the Toxic Substances Control Act (TSCA) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.”  The current TSCA Section 4(h)(2)(C) List is available on the EPA website.  EPA’s 2018 Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program provides initial criteria for considering scientific reliability and relevance of new approach methodologies (NAM) to be eligible for placement on the List.  EPA states that it “envisions that any party interested in proposing a NAM for placement on the List would use a nomination form.”  The webinar will walk through the proposed nomination form.
 
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) International Science Consortium, EPA, and the Physicians for Responsible Medicine (PCRM).  EPA notes that it does not necessarily endorse the views of the speakers.


 
By Lynn L. Bergeson and Carla N. Hutton
 
On August 3, 2020, the U.S. Environmental Protection Agency (EPA) announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics.  According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  EPA is providing a grant of up to $800,000 to each research team through its Science to Achieve Results (STAR) Program.  EPA states that the projects will address gaps in ways to obtain data for informing chemical toxicokinetics and exposure-related factors not currently considered.  The five recipients include:
  • Purdue University to create an integrated blood brain barrier computer model to help determine if a chemical may cause neurotoxicity;
     
  • Texas A&M University to help integrate different types of chemical safety testing for more robust results;
     
  • University of Nevada to develop better estimations of the bioavailability of chemicals to assess the significance of public exposure;
     
  • Vanderbilt University to work on methods to refine organ-on-chip devices for chemical testing; and
     
  • Woods Hole Oceanographic Institution to determine how zebrafish metabolism can be better correlated to the human metabolism to improve models for chemical toxicity testing.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 24, 2020, the U.S. Environmental Protection Agency (EPA) released a New Approach Methods (NAM) Work Plan that will “serve[] as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler’s 2019 Directive.”  According to EPA’s June 24, 2020, press release, the Work Plan describes how EPA plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals.  EPA states that compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  The objectives of the Work Plan include:

  • Evaluating regulatory flexibility for the use of NAMs;
     
  • Establishing baselines and metrics for assessing progress;
     
  • Developing NAMs that fill critical information gaps;
     
  • Establishing scientific confidence in NAMs;
     
  • Demonstrating NAMs application to regulatory decisions; and
     
  • Engaging with stakeholders to incorporates their knowledge and address their concerns regarding EPA’s phaseout of mammalian testing.

EPA states that the Work Plan will evolve as EPA’s knowledge and experience grow and as outside experts offer their perspectives and contributions.  EPA will regularly review the Work Plan to ensure that the efforts involved provide the best path to success.  More information on the 2019 directive to prioritize efforts to reduce animal testing is available in our September 11, 2019, blog item, “EPA Administrator Signs Directive Intended to Reduce Animal Testing, Awards $4.25 Million for Research on Alternative Methods to Animal Testing.”
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host its first annual conference to discuss alternative test methods and strategies to reduce animal testing on December 17, 2019, in Washington, D.C.  According to EPA, the conference will bring together some of the leading voices in environmental and health research to discuss efforts to reduce testing on mammals.  The conference will focus on the New Approach Methods (NAM) and will feature presentations by U.S. and international scientific experts on advancements in the field.  On-site participants will have the opportunity to exchange information about scientific advancements in the NAMs field to develop a better understanding of the state of the science, discuss approaches for developing scientific confidence in using alternatives, and summarize existing studies characterizing the uncertainties in results from animal testing.  The public can register to participate via webinar.
 
As reported in our September 11, 2019, blog item, on September 10, 2019, EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing.  The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035.  Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.”
 
EPA notes that over the past several years, it has made significant scientific advancements in NAMs and has led efforts to reduce, replace, and refine its animal testing requirements.  On December 5, 2019, EPA updated the list of NAMs that it developed pursuant to the Toxic Substances Control Act (TSCA), as amended by the 2016 Lautenberg Chemical Safety Act.  EPA states that it “will continue to lead the way among federal agencies in the United States and internationally.”


 
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