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EPA Meets Another TSCA Milestone, Releases Draft Strategy to Reduce Animal Testing

03/07/2018
Contact Information: 
EPA Press Office (press@epa.gov)

WASHINGTON (March 7, 2018) — Today, U.S. Environmental Protection Agency (EPA) is releasing a draft strategy to reduce the use of vertebrate animals in chemical testing for public comment. This fulfills another milestone the Agency has met under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act (TSCA).

“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.”

Under the Lautenberg Chemical Safety Act, 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. 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 follows the progress EPA has made finalizing three important rules and proposing a fees rule as outlined by the Lautenberg Chemical Safety Act. EPA is working diligently to implement the new law, the first major update to an environmental statute in 20 years, and get the most modern and safe chemicals to market quickly in order to provide regulatory certainty for manufacturers and confidence for American consumers.

This draft strategy will be available for comment for 45 days in docket EPA-HQ-OPPT-2017-0559. Comments received will be considered in the Agency's development of the final strategy. 

A public meeting will be held on the draft strategy in Washington, DC on  April 10, 2018.

Read the draft strategy and learn more about the April 10 public meeting: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce

Background

On June 22, 2017 – the one-year anniversary of the Lautenberg Chemical Safety Act – EPA met milestones for three framework TSCA rules: the Prioritization Process Rule, the Risk Evaluation Process Rule, and the Inventory Rule.

The Prioritization Process Rule establishes a framework and criteria for identifying high-priority chemicals for EPA risk evaluations.

The Risk Evaluation Process Rule establishes a framework for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health and/or the environment. The rule ensures transparency and confidence in the risk evaluation process while retaining flexibility to allow for new scientific approaches as they are developed.

The Inventory Rule requires industry reporting of chemicals manufactured, imported, or processed in the U.S. over the past 10 years to identify which chemical substances on the TSCA Inventory are active in U.S. commerce. This will inform the chemicals EPA prioritizes for risk evaluations.

In addition to finalizing framework TSCA rules so the Agency can properly implement the law within the timeframes set by Congress, EPA has effectively addressed and eliminated the backlog of new chemicals awaiting EPA review. The current caseload is back at the baseline level.

EPA also proposed a fees rule on certain chemical manufacturers – including importers and processors – to provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law. 

For more information on TSCA implementation, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act-5