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Call for Nominations -- Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment

Call for Nominations -- Committee on Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment

 
The National Academies of Sciences, Engineering, and Medicine is undertaking a study to provide the Environmental Protection Agency (EPA) with a review of the variability and relevance of existing laboratory mammalian toxicity tests for human health risk assessment to inform the development of approaches for validation and establishing scientific confidence in using New Approach Methods (NAMs), and recommendations on expectations associated with NAMs when they cannot be compared with human studies. The work of the study committee will be informed by an initial public workshop, by a literature review that addresses the variability and human relevance of current laboratory mammalian toxicity tests and approaches to validation and establishing scientific confidence in using NAMs, and by public information gathering meetings organized by the study committee.

The proposed charge questions are as follows:
 
(1)  Does the committee assess the literature review and data provided as reflecting a comprehensive, workable, objective, and transparent process?

(2)  Given the results of the literature review and workshops, what are the implications of the qualitative and quantitative variability of laboratory mammalian toxicity studies when using them to establish the performance of NAMs?

(3)  What do the literature review and workshops indicate about concordance between laboratory mammalian models and humans in the adverse effects following chemical exposure and how might this frame expectations of NAMs when they cannot be compared directly with human studies?

(4)  The Committee shall impart expert advice on addressing the two related issues that were left unresolved in the 2017 NRC report:

      (a) Evaluation of the validity of assays that are not intended as one-to-one replacements for in vivo toxicity assays; and
      (b) Assessment of the concordance of data from assays that use cells or proteins of human origin with toxicity data that are virtually all derived from animal models. 

(5)  Based on the conclusions from 1 – 4 above, how may the Committee foresee this information being incorporated into a new or the existing validation paradigm or scientific confidence framework so that EPA can ensure that NAMs are equivalent to or better than the animal tests replaced?

 
The study will be carried out by a committee of approximately 15 volunteer experts with expertise in the fields of:
  • In vitro assay development,
  • Model systems toxicology,
  • Human health risk assessment,
  • Biostatistics,
  • Veterinary medicine, and
  • Whole live animal alternatives (in silico and in vitro systems)

Once the full committee of about 15 members is formed, we will ask a subgroup of 8-10 volunteers to help organize the initial public workshop, with planning beginning in June. The other committee members will participate in the workshop but will not begin their full service until the beginning of the consensus study, expected in September.

The National Academies are committed to enhancing diversity and inclusion in order to strengthen the quality of our work. Diverse perspectives contribute to finding innovative approaches and solutions to challenging issues. We encourage the nomination of volunteers who reflect the populations we serve and also welcome in particular nominations of candidates from underrepresented racial and ethnic groups, women, and early- and mid-career professionals.


We invite you to submit nominations for committee members and/or reviewers for this study by Thursday, May 13, 2021.

Contact information:
Name:  Clifford Duke
Email:  cduke@nas.edu
Phone:  202-334-3591
Project Website Link