Results of FDA OFVM Program Review of CFSAN’s Chemical Safety Program

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Results of FDA OFVM Program Review of CFSAN’s Chemical Safety Program

Author: Sherry Ward, AltTox
“The U.S. Food and Drug Administration has completed a review of how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed, and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes. The chemical safety assessment review is the first of three planned strategic reviews being conducted under the direction of the FDA’s Office of Foods and Veterinary Medicine (OFVM). …”

“Among the review’s most significant outcomes: the centers, led by CFSAN, will develop a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (also called the “Redbook”), so that it reflects current science. Additionally, the centers will jointly develop a process to ensure consistency of methodologies used for safety and risk assessments within and across offices at CFSAN, and between CFSAN and CVM.” (

The issues and recommendations in the report are presented within three broad categories:
•   Science
•   Communication and Collaboration
•   Training and Expertise

The “Science” recommendations, as summarized in the Executive Summary of the report, are the following:
•   Establish an in silico knowledgebase to assist in the proactive identification and ranking of emerging chemical hazards, risks, and new science. In silico refers to information obtained using a computer or via computer simulation, in contrast to information obtained from biological systems (in vivo, in vitro, and in situ).
[The in silico knowledgebase was ranked as the highest science priority by CFSAN, but was ranked lower by CVM (] •   Increase the availability of and access to databases to improve the strength and reliability of hazard identifications and safety/risk assessments.
•   Promote the development of mechanisms and forums that increase communication and exchange among toxicologists to improve and encourage scientific excellence, understanding, and consensus, and thus consistency in CFSAN’s chemical safety/risk assessments.
•   Increase opportunities for cross-organizational internal peer review of chemical safety projects.
•   Increase engagement with other Federal agencies to leverage their scientific expertise as a resource on major chemical safety/risk assessments and other key work products.
•   Determine to what extent consistency on the methodology used for chemical safety/risk assessment between and across offices at CFSAN and between CFSAN and CVM is achievable.
•   Develop standard operating procedures (SOPs) to help ensure consistency within CFSAN Offices on chemical risk assessments/safety assessments.

The Working Group stated their belief “that implementation of the recommendations contained in this report will significantly improve the effective and efficient use of CFSAN’s chemical safety resources, and help to ensure the rigor and effectiveness of the chemical safety program and maintain and strengthen its national and international leadership role in food and cosmetic chemical safety.”

The full report, “REPORT OF THE CFSAN CHEMICAL SAFETY ASSESSMENT REVIEW WORKING GROUP Evaluation and Summary of the Results of the FDA OFVM Program Review of CFSAN’s Chemical Safety Program” is available here:

For links to the report’s appendices, see this page: