CVM’s GRAS Notification Program is Up and Running

By Diane B. McColl & Ricardo Carvajal –

It’s here!  FDA’s Center for Veterinary Medicine (“CVM”) finally implemented a "generally recognized as safe" (“GRAS”) notification program for use of ingredients in animal feed or pet food.  We have waited for this program since 1997, when it was first proposed along with FDA's Center for Food Safety and Applied Nutrition's (“CFSAN's”) GRAS notification program for human food ingredients.  CVM's efforts to establish the program were announced more than a year ago.  In the ensuing months, producers of potential new ingredients met with CVM, trying to understand how the program might work.  Now we have a basic framework.  CVM's GRAS notification program food parallels CFSAN's GRAS notification program, which has operated successfully for more than 10 years.  As CFSAN did in the early days of its program, CVM “strongly encourages” potential notifiers to discuss their plans with the Division of Animal Feeds prior to submission.

Based on CVM’s Federal Register notice and the instructions provided on its website, it appears that CVM intends to administer its program so that it is both substantively and procedurally consistent with CFSAN’s program -  with a couple of notable exceptions.  First, if the ingredient will be fed to food-producing animals, safety of the ingredient must be shown   both for target animals consuming the ingredient and for humans consuming food derived from those animals.  Thus, for both the target animal and the human populations, a GRAS notifier must establish that the proposed use of a food ingredient is not just safe, but also generally recognized as such.  Second, CVM describes its program as a “pilot” program, and notes that resources are limited in the animal food program.  Consequently, CVM does not commit to a specific time frame for responding to notifications.  While CFSAN originally set a target of 90 days for its GRAS notifications, that target has crept up to 180 days.

As with CFSAN’s program, notifiers under CVM’s program should expect their GRAS determination claims to become publicly available on the date that the GRAS notice is received.  Pivotal safety data and information (i.e., those data without which the GRAS determination cannot stand) should already be in the public domain.  Other data and information in the GRAS notice will immediately be made available to the public, subject to exemptions in FDA’s regulations implementing the Freedom of Information Act (21 C.F.R. Part 20).