FDA Announces GRAS Notification Pilot Program On Animal Food

Date: Jul 06, 2010

In the June 4 Federal Register,[1] the Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM) published a Notice announcing the establishment of a pilot program for generally recognized as safe (GRAS) substances added to animal food. FDA is seeking participants for the voluntary program which will permit participants to submit to the Agency notices of claims that a particular use of a substance in animal food is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is GRAS. This program is CVM's implementation of the 1997 proposed rule to replace the current petition process.[2]

Description of the CVM Pilot Program

In general, the agency will implement the pilot program for substances added to animal food in the same manner as the interim policy for substances added to human food and as described in section VIII of the 1997 proposed rule.[3] In addition, the Notice indicates that CVM has consulted with the Center for Food Safety and Applied Nutrition (CFSAN) and made its administrative procedures consistent with those of CFSAN.[4] For substances that will be a component of animal for food producing animals, the notifier will need to address human food safety as well.

The Notice strongly encourages potential participants to contact the Division of Animal Feeds prior to submitting notices to discuss their submission plans. According to the Notice, CVM will acknowledge receipt of the submitted notices in writing within 30 days and respond the notifier in writing as quickly as resources permit. Based on informal discussions we have had with the agency, we estimate that for early submissions CVM will likely provide a response in 4 to 6 months. Under the program, FDA intends to evaluate the notices, and will inform the notifier if the notice provides a sufficient basis for a GRAS determination, or, alternatively, whether there are any questions as to whether the intended use of a substance is GRAS.

[1] The published copy is available at: http://edocket.access.gpo.gov/2010/pdf/2010-13464.pdf

[2] See 62 Fed. Reg. 18938 (April 17, 1997)

[3] See 62 FR 18938 at 18954 through 18955 (April 17, 1997)

[4] Information about the CFSAN's notification program and relevant guidance documents is available at: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/