EPA Strategizes Alternative Methods for Vertebrate TSCA Testing

As required by the Section 4(h) of the 2016 amendments to the Toxic Substances Control Act (TSCA), the EPA is in the process of preparing a strategic plan “to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing.” Under the section, the alternatives and strategy must provide information of equivalent or better scientific quality and relevance that will support TSCA regulatory decisions. The final strategy is due by June 2018.

On November 2, 2017, the EPA participated in a meeting to obtain input from interested parties and the public on the Agency’s development of the strategic plan. The meeting was coorganized with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which comprises 15 federal research and regulatory agencies, including the EPA, that work together to advance the acceptance of scientifically valid alternative test methods. Alternative test methods are those that replace or reduce the use of animals, or refine their use, such as enhancing animal well-being, and lessening or avoiding pain and distress.

Risk-Based Decision Making

“There are many alternative test methods and strategies currently available and potentially useful for some regulatory purpose,” notes the EPA. “Under TSCA, the major needs are for risk-based decision making for both new and existing chemicals, and prioritization of existing chemicals for eventual risk evaluation. Combinations of actual test methods, computer models, and tiered testing/evaluation approaches all play important roles given the regulatory context.”

Major Considerations

In presentation materials prepared for the meeting, the Agency summarized “overarching considerations important to the strategic plan” as follows:

• Understanding the concept expressed throughout the law of implementing new approach methodologies (NAMs)—“to the extent practicable (and) scientifically justified.”
• Identifying and promoting advances in science and NAMs (including training)
• Fostering collaboration with domestic and international stakeholders inside and outside the government on NAMs
• Communicating with and educating the public
• Needing to identify appropriate information to replace vertebrate animal testing
• Enhancing and harmonizing IT systems to maximize the use of existing information and assessments
• Developing a new risk evaluation paradigm for human health and the environment for new and existing chemicals in U.S. commerce, which uses nonanimal alternative test methods and strategies

Five-Year Goals

In the presentation, the EPA also lists near-, mid-, and long-term goals of the strategy. These include

• Near-term (2018–2020)
  • Use NAMs to identify chemical candidates for prioritization.
  • As prioritization candidates are identified, consider NAMs to fill data gaps.
  • Work with partners to identify research gaps and promote advances in NAMs relevant to TSCA needs.
• Mid-term (2020–2022)
  • Use NAMs in developing and improving priority existing chemical category(ies).
  • Use NAMs (where possible) for qualitative use in risk evaluation.
• Long-term (2022 and beyond)
  • Use NAMs (where possible) for quantitative use in risk evaluations.

The TSCA amendments require that every 5 years from 2016, the EPA must provide Congress with a report that describes the progress made in implementing the strategic plan along with goals for future alternative test methods and strategies implementation.

Comments Requested

The Agency is also inviting written comments on what the strategic plan should contain. Comments may be submitted to docket EPA-HQ-OPPT-2017-0559 at www.regulations.gov and must be received no later than 60 days following the November 2 meeting. A draft of the strategic plan will be shared with the public for comment, says the EPA.

Material developed for the meeting is here.

Information on the ICCVAM is here.