The National Grain and Feed Association (NGFA) has urged the Food and Drug Administration (FDA) to finalize its proposed regulations that would establish a voluntary notification procedure to affirm the “generally recognized as safe” (GRAS) status of ingredients intended for use in animal food.
In a statement submitted in response to FDA’s request for comments, the NGFA said it “strongly supports” the agency’s efforts to finalize its proposed voluntary GRAS-notification procedure. Under those procedures, persons – called “notifiers” – may submit to the agency notices of claims that a particular use of a food substance is GRAS, and thereby is exempt from other legal premarket-approval requirements as authorized under the federal Food Drug and Cosmetic Act (FFDCA).
In its statement, the NGFA noted that such a program would be an efficient and effective process for both the animal food industry and FDA. The NGFA also said it would serve as a valuable tool for the industry to access the safety of ingredients used in animal food, while also making the agency’s determinations available to the public.
The opportunity for substances to gain GRAS recognition for use in animal food is based upon the 1958 food additives amendment to the FFDCA. To qualify for GRAS status, the specified use of the food substance is required to meet two necessary elements – a “technical” and a “common-knowledge” element. The technical element requires that available information about the food substance establish that it is safe for its intended use. The common-knowledge element includes two facets: 1) the data and information relied upon to establish the technical element must be generally available; and 2) there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use.
In response to specific issues posed by FDA in its request for comments, the NGFA recommended that:
- FDA incorporate the concept of studies being “generally available and accepted” within the description of the common-knowledge element. In doing so, the NGFA noted that such a concept is appropriate and consistent with the FFDCA. Further, the NGFA emphasized that studies should not necessarily need to be published in a peer-reviewed journal to be relevant and acceptable for the GRAS-notification process.
- FDA include a provision in the final rule that makes notifiers clearly aware that they may at any time withdraw a notice during its evaluation by FDA. The NGFA stated that such a provision potentially would provide the affected notifier with an opportunity at a later date to appropriately resubmit a notice for which FDA initially has questions.
- GRAS submissions typically should exclude trade secrets, yet provide enough detail to FDA concerning the manufacturing process so the agency may complete appropriately its safety assessment. However, the NGFA acknowledged that there may be limited situations in which submission of trade secret information is necessary to allow FDA to make an adequate safety assessment; if so, the NGFA said, such information should be subject to existing confidentiality protections.
- The parameters required by FDA to establish the proof of utility of a substance within the GRAS-notification process be limited to information necessary to conduct an appropriate safety assessment. However, the NGFA noted that it should not be necessary for the notifier to submit additional information to demonstrate the technical effect of the substance within animal food in cases where such an effect has no impact on food safety.
- FDA retain its proposed 90-day timeframe to respond to a GRAS notice. The NGFA said that such a timeframe would provide an incentive to manufacturers to submit GRAS notices and use the notification process, thereby increasing the agency’s awareness of the composition of the ingredients used in animal food and providing an opportunity for FDA to review the safety parameters of such ingredients.