2017-24845: Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Best Practices for Convening a GRAS Panel." This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts ("GRAS panel") to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a "GRAS panel report"), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).

The agency’s own summary, as published.

What this changes

Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 170 Food Additives
• 21 CFR 570 Food Additives