Environmental Protection Agency of the US is prioritizing the attempts to develop and use New Approach Methods (NAMs) for chemical testing. This new approach will help in reducing the usage of animals as subjects in chemical testing while ensuring the protection of human health and the environment. NAMs are equivalent to “alternatives" to animal testing.

The EPA has a broad range of information that is obtained from animal tests, which can be used to evaluate the risks of chemicals, assess their potential impacts on the environment. As the EPA regulates a large number of chemicals, the number of animals used to generate the required information is substantial.  

Therefore, the EPA introduced a new work plan to prioritize Agency efforts and resources towards reducing the use of animals in testing while continuing to protect human health and the environment. The Work Plan includes the following objectives:

Establish Regulatory Flexibility for Accommodating NAMs

A thorough review of existing statutes and programmatic regulations, guidance and policies to identify mammalian testing requirements, will be performed by the EPA staff. This helps to consider options for using appropriate NAMs. A report will be soon issued in 2021 with details of the findings of this review.

Develop Baselines and Metrics for Assessing the Progress

EPA will develop baselines and metrics for animal use based on the previous data within the Office of Research and Development and Office of Chemical Safety and Pollution Prevention. Later on, this approach will be progressively extended to other EPA offices based on certain criteria. 

Provide Scientific Confidence in NAMs

EPA will characterize the scientific quality and relevance to existing animal testing to establish scientific confidence in NAMs, and then develop a framework to evaluate the NAM's quality and reliability. The application of NAMs to different Regulatory aspects will be demonstrated through case studies each year beginning from 2022.

Fill Important Information Gaps

In chemical safety research, the EPA will facilitate joint development of NAMs by the EPA scientists and regulators to fill important information gaps. Research plans on a regular 4-year planning cycle will be developed to promote collaboration.

Communication with the Stakeholders 

EPA-related NAM information will be provided in a centralized portal to assure transparency and accountability, with feedback and comments from stakeholders being actively approached. Training, courses, workshops and conferences are conducted for interested stakeholders to learn more about the NAMs research and data. 

This action shows how the EPA is trying to achieve the goal of eradicating the use of mammals in chemical testing by 2035. Hence, stakeholders must keep abreast of the upcoming guidelines on animal testing and act accordingly. Stay informed. Stay compliant.


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