CVM addresses questions about GRAS program

David Fairfield of the NGFA shared with the Pet Food Institute answers to questions he raised with FDA regarding the GRAS notification program for animal feed announced earlier this year.

David Fairfield of the  National Grain & Feed Association  (NGFA) shared with the Pet Food Institute  (PFI) answers to questions he raised with FDA regarding the GRAS notification program for animal feed announced earlier this year.

Geoffrey Wong, leader of the ingredient safety team at the Center for Veterinary Medicine  (CVM), provided the answers.

David Fairfield: Is there a planned date for when the program will be launched?

Geoffrey Wong: CVM plans to start the pilot program late summer of 2009. However, this date is not definite and will be impacted by a number of factors, such as receiving proper authorization to publish a Federal Register notice that will announce the pilot program.

DF: As I understand, this program is being characterized as a "pilot" project. I am curious as to what this means, such as will the agency initially be limiting the scope of the program to certain ingredients and to a certain timeframe?

GW: The program is considered a pilot program in the sense that the April 17, 1997 proposed rule has not yet been finalized. We intend to be operating under an interim policy similar to the one described in Section VIII of the April 17, 1997 proposed rule. The scope of the program will include substances intended for use in food for animals.

DF: Will there be an established timeframe for the agency to respond to industry GRAS notice submittals?

GW: CVM does not plan to have formal statutory deadlines of when the agency must respond to a firm's GRAS notification. Our timeframes for reviewing the notices will be largely impacted by the resources available to CVM to implement the program.

DF: Will animal feed ingredients that receive a "no questions" review from CVM be listed in the  Association of American Feed Control Officials  (AAFCO) Official Publication ?

GW: The FDA evaluation process for AAFCO feed ingredient definitions is very different from FDA's process to evaluate GRAS notifications and these processes result in agency conclusions which are not equivalent.

In the AAFCO ingredient definition process, CVM serves as a science advisor to AAFCO to establish ingredient safety, evaluate utility of the ingredient for specific use (claim), and determine if the manufacturer's process in under control and analytical methods are acceptable.  As part of the review, FDA often evaluates proprietary safety data, utility data, and manufacturing data submitted by the firm.

In contrast for GRAS notifications, FDA reviews summarized data and information submitted by the notifier and data and information otherwise available to the Agency, to determine whether there is a basis to question the notifier's view that the technical element (evidence of safety) and both facets of the common knowledge element regarding the use of the substance are satisfied - i.e., general availability and general acceptance (consensus).

CVM intends to have discussions with AAFCO to understand the manner in which state feed control officials will recognize a response letter from the agency stating that it has no questions regarding the rotifier's determination that the substance is GRAS under the intended conditions of use in animal food.

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