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Assessing and Managing Chemicals under TSCA

Alternative Test Methods and Strategies to Reduce Vertebrate Animal Testing

The Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, directs EPA to:

  • reduce and replace, to the extent practicable and scientifically justified, the use of vertebrate animals in the testing of chemical substances or mixtures; and
  • promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing.

TSCA also requires EPA to develop a strategic plan on this topic and provide a progress report on the implementation of the plan to Congress every five years since the date of the enactment of the Lautenberg Chemical Safety Act, i.e. beginning in 2021.

In 2018, EPA published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the TSCA Program. The Strategic Plan incorporated input from two public meetings and written comments submitted on the draft strategic plan.

Read the Strategic Plan and associated documentation, including the initial List of Alternative Test Methods and Strategies (or New Approach Methodologies [NAMs]).

The Strategic Plan has three core components: (1) identifying, developing and integrating NAMs for TSCA decisions; (2) building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions.

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Implementing the Strategic Plan

EPA is working to ensure full implementation of the Strategic Plan and development and adoption of NAM approaches. A complete list of ongoing and proposed activities is detailed in Chapter 7 of the Strategic Plan. 

EPA has made important progress implementing the following near-term activities (2018-2021) in the Strategic Plan:

1. Continue to implement NAMs to evaluate hazard, exposure and environmental fate for new and existing chemicals

EPA has a long history of using NAMs, such as quantitative structure activity relationship (QSAR) and read-across, for hazard identification and fate characterization and modeling for exposure assessment. This activity is ongoing and reflects EPA’s commitment to using NAMs for decision making in the TSCA program, when available and possible.

In 2018, EPA released a draft policy to reduce animal testing for skin sensitization. The Agency is currently considering public comments received on the policy.

2. Maintain and regularly update a list of NAMs per Section 4(h)(2)(C)

EPA published a list of NAMs in June of 2018 and committed to updating the list at least once a year. The first update was released in December 2019. Additionally, EPA plans to release a draft proposal on a process for selecting which NAMs will be included on future versions of the list. This draft proposal will be released for public comment in early 2020.

3. Identify and maintain a list of most requested/needed studies for new and existing chemicals under TSCA

EPA is conducting a retrospective analysis to identify and evaluate studies the Agency has requested or received for new and existing chemicals under TSCA. The results of this analysis will be made publicly available in early 2020.

4. Identify and curate available existing TSCA information on NAMs (and traditional test data)

EPA is cataloging and analyzing NAMs information it has received from industry submissions under TSCA. The results of this TSCA in-house inventory of NAMS information will be made publicly available in early 2020, to the extent possible with information claimed as CBI, to advance the development and implementation of NAMs.

5. Use of NAMs to identify candidates for prioritizing existing chemicals for TSCA risk evaluation.

EPA is required to prioritize chemicals under TSCA for designating chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluation is not warranted at the time.  The first list of chemicals undergoing prioritization was published on March 20, 2019. EPA is exploring ways to incorporate NAMs into the prioritization process.

6. Begin development of scientific information technology platforms

EPA is actively working on and improving its information technology platforms to better integrate information from multiple databases related to new chemical submissions.

7. Collaborate with partners and stakeholders to identify NAMS for further development

EPA has partnered with the People for the Ethical Treatment of Animals (PETA) and the Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to meeting the goal of reducing, refining, or replacing vertebrate animal testing (PEP Webinars).Exit

EPA is also reaching out to academic, industry, and other stakeholders  to exchange ideas and discuss best practices for reducing animal testing.

8. Launch TSCA NAM website

On this webpage, EPA is providing information on how the Agency is using NAMs and working to reduce animal testing in the TSCA program. This page will be updated regularly as the Agency progresses in implementing the Strategic Plan.

General Information on NAMS

NAMs refer to any technology, methodology, approach (including computational/in silico models like QSARs), or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of intact animals. For the purposes of TSCA, EPA recognizes this new term (i.e., NAMs) as encompassing any “alternative test methods and strategies to reduce, refine, or replace vertebrate animals.”

Examples of NAMs would be in vitro tests or assays, in chemico assays and in silico algorithms. In vitro studies are experiments which use human or animal cells. In chemico studies are experiments which do not use any human or animal cells, but simply evaluate how a chemical interacts/reacts with certain materials. Finally, in silico is the term used for computer-driven predictive tools.

Another example includes the use of analogue/read-across approaches to evaluating toxicity. If you have a chemical (target chemical) for which you have no toxicity information, you may be able to use information available on a structurally similar chemical (analogue) in a read-across approach. Another example would be to apply the principles of QSAR to predict toxicity.

Using NAMs in the TSCA Program

EPA’s TSCA program covers many chemicals consisting of a wide spectrum of chemistries, from simple organic molecules to complex mixtures, reaction products, and polymers. Through the development and implementation of the Strategic Plan, EPA is building a strong foundation of which information and tests are necessary to assess the safety of new and existing chemicals. Building on that foundation, EPA will work internally and with stakeholders to identify, develop, and use NAMs to evaluate new and existing chemicals under TSCA.

Additionally, EPA has established the TSCA NAM Team, a group of scientific experts established to help in the implementation of the Strategic Plan. The team consists of EPA staff and managers from across the Office of Chemical Safety and Pollution Prevention (OCSPP), which includes - the Office of Pesticide Programs (OPP), the Office of Science Coordination and Policy (OSCP), and the Office of Pollution Prevention and Toxics (OPPT), as well as the Office of Research and Development (ORD). The team will engage with a variety of stakeholders including the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the Organization for Economic Co-operation and Development (OECD), and other entities and individuals for insight and advice on the implementing the Strategic Plan.

Additional Information on NAMs

In addition to the work EPA is doing to integrate the use of NAMs into the TSCA program, other programs within OCSPP and across the Agency are working on the development and use of NAMs.

For more information on the use of NAMs in the TSCA program, contact Louis Scarano (Scarano.Louis@epa.gov).