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) announced on January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing. A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity. Drs. Nicole Kleinstreuer and Kamel Mansouri will discuss the development of and demonstrate CATMoS, which was developed during a project in which the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the EPA National Center for Computational Toxicology (NCCT) collected a large body of rat oral acute toxicity data and made these data available to project participants. Participants built several models that were then used to generate consensus predictions for the acute oral toxicity endpoints of interest to regulatory agencies. The webinar will offer a walk-through of how to use the modeling suite to generate acute oral toxicity predictions for chemicals of interest. EPA notes that it “does not necessarily endorse the views of the speakers.”
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.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) issued a press release on September 10, 2019, announcing that EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing. Administrator Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing. Administrative Wheeler directs the Office of Chemical Safety and Pollution Prevention (OCSPP) and the Office of Research and Development (ORD) “to prioritize ongoing efforts and to direct existing resources toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment.” 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.” Administrative Wheeler requests that OCSPP and ORD hold a joint animal conference on new approach methods (NAM), with the first conference to be held in 2019.
Five universities were awarded grants through EPA’s Science to Achieve Results Program. According to EPA, the research focuses on advancing the development and use of alternative test methods and strategies to reduce, refine, and/or replace vertebrate animal testing. The grantees are advancing the science of non-vertebrate alternative test methods and strategies in chemical hazard assessment. The grantees include:
- Johns Hopkins University to develop a human-derived brain model to assess the mechanism by which environmental chemicals might cause developmental neurotoxicity;
- Vanderbilt University to test their organ-on-a-chip to study the blood brain barrier and potential brain injury after organophosphate exposure;
- Vanderbilt University Medical Center to use their Endo Chip technology to research how preexisting diseases affect cellular responses to environmental toxicants with a focus on reproductive disorders in women;
- Oregon State University to develop in vitro test methods for fish species to screen chemicals in complex environmental mixtures; and
- University of California Riverside to use human cells to develop a cost-effective end point to characterize potential skeletal embryotoxicants.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA), specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT). Registration is required. The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”
The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAM) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances. EPA states that these webinars on the use of New Approach Methodologies (NAMs) in Risk Assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.
By Lynn L. Bergeson and Margaret R. Graham
On October 26, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on November 2, 2017, from 9:00 a.m. to 5:00 p.m. (EST) to obtain input from interested parties and the public on its development of a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. EPA is required under Section 4(h) of the Toxic Substances Control Act (TSCA), as amended, to develop this Strategic Plan by June 22, 2018. EPA states that it “will consider input from the meeting and from written comments to develop a draft Strategic Plan that will be shared with the public for comment.”
EPA has posted materials for the meeting to inform the Strategic Plan and that can be used for discussion and comment on its website, including:
EPA is requesting input about the draft Strategic Plan to be shared during the meeting and in the form of written comments that may be submitted to Docket No. EPA-HQ-OPPT-2017-0559 on www.regulations.gov; comments must be received no later than 60 days following the meeting. Registration for the meeting and further information is available on EPA’s Alternative Test Methods webpage.
The American Chemical Society (ACS), together with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and Honorary Co-Hosts Representatives Ken Calvert (R-CA) and Earl Blumenauer (D-OR), through ACS’ Science & the Congress Project have announced that they will be hosting a panel on “Alternatives to Animal Testing: Emerging Uses and Policy Implications” on Tuesday, September 13, 2016, from Noon - 1:30 p.m. on Capitol Hill at the Cannon House Office Building in Room 340. The panel will cover new and evolving non-animal based technologies and science that are being used to advance toxicology and safety testing and improve prospects in biomedical research, and will discuss how to robustly develop and incentivize adoption of these new methods, followed by an audience Q&A. Lunch will be provided. The moderator and panelists include:
- Pamela Frasch, J.D., Lewis & Clark Law School (Moderator);
- Warren Casey, Ph.D., National Institute of Environmental Health Sciences and the U.S. Department of Health and Human Services National Toxicology Program;
- Amy Clippinger, Ph.D., PETA International Science Consortium Ltd.;
- Paul A. Locke, J.D., Dr. P.H., JHSPH;
- Pamela J. Spencer, Ph.D., D.A.B.T., Scientific Director of Toxicology and Environmental Research & Consulting, The Dow Chemical Company.
Registration for the panel is available online.