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.