EPA Releases Draft Alternative Approach to Animal Testing

MARCH 12, 2018

EPA published its “Strategic Plan to Promote the Development and Implementation of Alternative Test Methods” draft document last week, outlining the Agency’s proposal to limit the use of animal testing for chemical safety determinations. The draft is the next step of the mandate in the June 2016 TSCA amendments that requires EPA to reduce testing on vertebrate animals to the extent practicable and to publish a final, strategic plan to promote alternative test methods by June 22, 2018.

In its draft, EPA notes the following objectives:

  • Identifying, developing and integrating NAMs [new approach methodologies] 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.

EPA wants to use the draft to implement NAMs related to chemical characterization, hazard identification and characterization, dosimetry, and in vitro – in vivo extrapolation, and exposure. 

“This draft strategy is a first step toward reducing the use of animals and increasing the use of cutting-edge science to ensure chemicals are reviewed for safety with the highest scientific standards,” said EPA Administrator Scott Pruitt. “EPA is committed to working with animal welfare groups and other groups to produce a sound, effective plan in line with the law.”

“We welcome the draft strategy as a progressive step to reduce and ultimately replace the use of animals to regulate chemicals in the U.S. through the implementation of TSCA reform,” said Catherine Willett, director of science policy at The Humane Society of the United States. “We have every indication that EPA intends to make good on this unprecedented opportunity to not only reduce animal use, but improve the science used to evaluate chemical safety.”

Additionally, in a Federal Register Notice the Agency noted that it would host a public meeting on April 10 in Washington, D.C. There will be an option to participate remotely.

In addition to the June 22, 2018 deadline, the Agency is also required to report to Congress every five years regarding its progress in implementing animal testing alternatives.

The new testing methods could provide a significant benefit to the chemical industry, including ILMA members, if the Agency officially sanctions alternatives that are more cost-effective and less time consuming to complete.​​