On March 7, 2018, the U.S. Environmental Protection Agency (EPA) released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA). Under amended TSCA, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing by June 22, 2018. EPA states the draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods.

The draft strategy outlines EPA’s Strategic Plan for the reduction of testing in vertebrates for chemicals regulated under TSCA. The organizing framework for the EPA’s strategy to reduce vertebrate animal testing relies heavily on what have been termed new approach methodologies (NAM) -- a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. The strategy describes a multi-year process with incremental steps for adoption and integration of NAMs that are appropriate and fit-for-purpose for making TSCA decisions, and has three core components:

  • Identifying, developing, and integrating NAMs for TSCA decisions;
  • Building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and
  • Implementing the reliable and relevant NAMs for TSCA decisions. The EPA has identified seven current/near-term (less that three years) needs and activities.

EPA states that completing these activities will result in moving towards four intermediate-term (three to five years) objectives and these time frames, needs, and activities provide the basis for developing NAMs, establishing reliability and relevance criteria for the NAMs, and implementing NAMs to inform decisions made under TSCA.

Comments on the draft strategy will be due 45 days after the notice of availability is published in the Federal Register. EPA has scheduled a public meeting to obtain input on the draft strategy for April 10, 2018, from 9:00 a.m. (EDT) to 5:00 p.m. (EDT) in Washington, D.C. Registration is available online and is requested by April 3, 2018.