Animal Defenders International


Animal Defenders International

Help save animals from US chemical safety tests.

Posted: 18 April 2018. Updated: 18 April 2018


An amendment to the Toxic Substances Control Act (TSCA) has the potential to save thousands of animals from unnecessary suffering.

Passed in the US Congress in June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act instructs the Environmental Protection Agency (EPA) to “reduce and replace” animal-based toxicity testing and to promote, develop, and incorporate non-animal alternatives, where possible.

The amendment specifically requires the EPA to develop a Strategic Plan by 22 June 2018, which they have drafted and are now inviting comment on.

You can help save animals from chemical safety tests by having your say on or before 26 April 2018!

The draft Strategic Plan is set out in three “components”, for which we have outlined the following responses to below.

Please note: ‘cut and pasted’ responses, template/form letters, petitions or identical submissions will not be considered. It is therefore vital that your submission be written in your own words, for which you can use our guidance points, and research further using the links to resources that are provided below.

When you are ready to do so, please submit your comment here.

You can write up to 5000 characters, including spaces. For fuller submissions you may upload a file using the following format: Attachment1_< insert title of document >

Thank you for taking action to help animals in research.

Guidance for submission

Component 1: identifying, developing and integrating New Approach Methodologies [NAMs] for TSCA decisions

ADI points:

  • It is good to see that the EPA has plans for collaboration with other international organisations for identifying new approach methodologies (which are non-animal) and using them to make decisions about the safety of chemicals. However, the EPA need also to look to specific countries that have been / or are currently undergoing similar efforts to phase out animal models, in particular where they have set measurable targets to work towards.

  • It is also good to see that the EPA has said the elimination of vertebrate animal testing is an achievable goal, but disappointing that they claim “it is not possible to identify a time-frame” when this will be eliminated”. The plans of the EPA need to go further and follow the examples of other nations.

For example:

  • In the Netherlands, the national committee advising on the use of animals in experiments has proposed to phase out the use of animals in regulatory safety testing by 2025. (Note to supporters: for further information, please view the Video and Report summary pages 3-5)

  • The Belgian government is aiming for a 30% reduction of animal use for safety testing by 2025 in Brussels, and to reduce the use of animals in basic research by 2045.

  • The 2009 ban on cosmetics testing (and 2013 ban on sales) in the EU created a huge innovation drive in the number of replacements available, leading to Europe being a world leader in the cosmetics industry, being influential in driving innovation, and bringing about bans in multiple other countries.

Component 2: building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions

ADI points:

  • In order to educate researchers and scientists about new approach methodologies and encourage confidence in their use, the EPA needs to justify why there is a need to move away from current animal models. This means acknowledging the issues with animal models such as their translatability to humans, which can cause human harm and can be scientifically and economically costly.

Note to supporters: A summary of the effects of species differences can be found here. Please also see: Innovate UK page 14; US National Institute of Environmental Health Sciences paragraph 1; Nature Editorial paragraphs 8-9 for details of how challenging attitudes to current animal methods has been identified as a barrier to the uptake of animal-free method.

Component 3: implementing the reliable and relevant NAMs for TSCA decisions.

ADI points:

  • To speed up their acceptance and stress the urgency for their development, new approach methodologies should be given special status as part of the EPA’s Strategic Plan.

  • To accelerate their development and uptake, such methods should be subject to preferential treatment at all stages of their research, development and commercialisation with funding directed away from animal research and towards developing new approach methodologies. Regulators should fast track applications with innovative technologies that aim to replace traditional animal methods; the validation process should be simplified and made faster than it currently is. (Note to supporters: See stakeholder comments in the document “Response to EPA meeting of 2nd November” (especially page 7 “Response 9”).

General background information on the EPA’s draft Strategic plan can also be found on the EPA website and on

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