In an effort to help expand the acceptance of alternative methods for acute toxicity testing, EPA’s Office of Pesticide Programs has released a new draft guidance document. The agency is accepting comments on the draft guidance for 60 days, until March 10, 2015. With the rapid advances in science and continual development of new technologies, the EPA recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments.

The agency’s goals for alternative testing approaches include:

  • assessing a broader range and potentially more human-relevant adverse effects;
  • generating and reviewing data more quickly and less expensively; and
  • reducing use of laboratory animals in regulatory testing.  

The draft guidance, Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies, describes a transparent, stepwise process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. In addition, there is a discussion of the three major phases of the process, and the implications for reporting information under section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act.  Successfully putting this process into place will require an open dialogue with stakeholders, other regulatory organizations, and the scientific community.

Please submit any comments on the draft guidance to Christopher Schlosser by email at or regular mail at Christopher Schlosser, U.S.E.P.A, 1200 Pennsylvania Avenue, NW, MC 7509P, Washington, DC 20460.

This draft guidance is one step in the application of the Office of Pesticide Programs’ strategic vision for implementing the 2007 National Research Council report on Toxicity Testing in the 21st Century.