Regulatory Update from AFIA’s Committee Meeting 2015
At the January 2015 American Feed Industry Association (AFIA) Committee Meeting, there were several important discussions regarding the current and upcoming federal and state regulations for animal feed and pet food.
FDA/ CVM and AAFCO Memorandum of Understanding
The Memorandum of Understanding (MOU) between the Center for Veterinary Medicine (CVM) and the Association of American Feed Officials (AAFCO) had last been extended until September 1, 2015; however, CVM is proposing to extend the MOU until 2017. AAFCO has not yet responded to this proposal, and the consensus is that AAFCO may want some concessions from CVM in order to sign off on MOU. Timing of AAFCO response is an issue, because regardless of the proposal AAFCO makes, CVM has indicated that it will take six months to review the MOU before approval; therefore, there could be a gap in time not covered by the MOU.
Citizen Petitions
Richard Sellers, Senior Vice President of AFIA, was not optimistic regarding submission of either of two Citizen Petitions prepared by the AFIA legal team. One petition addresses the extensive documentation for ingredient utility and the other addressing the poor/unfair notification process in general.
More on Proposed “Technical Fixes”
An amendment may be proposed to the Federal Food, Drug and Cosmetic Act (FFDCA) to separate out the definition of food from feed, making animal feed a special category. Although not much detail was disclosed a major feature would be to have the AAFCO ingredient definitions incorporated into regulation and definitions/specifications treated as synonymous with “standards” (for pet food) as required by Food and Drug Administration Amendments Act (FDAAA) 2007. The probability of the passage of this amendment is low, given that previous attempts for similar Congressional changes have been rebuffed and a similar “grandfathering” of existing ingredients failed to pass Congress 50+ years ago at the time of the original 1958 Amendment to the Act. If such an amendment is proposed to the Act, some members of Congress may see this as an opportunity to eliminate the GRAS provision for animal feed, if not for human food as well. This action may be a can of worms no one wants to open.
GRAS, FAPs and the AAFCO OP
Dr. Dan McChesney, the Director of the Office of Surveillance and Compliance at CVM gave an interesting update to the GRAS Notice Pilot Program Progress which, he indicated, is “moving right along”. Dr. McChesney disclosed that CVM is not covered by the Center for Food Safety and Applied Nutrition’s (an advocacy group, CFSAN) court order to finalize the GRAS notification program. There was discussion about a “statutory time frame” (actually, a regulatory time frame) for responding a GRAS notification: Dr. McChesney noted that on the human side, there is a CFSAN self-imposed 180-day turn-around from the time of filing to response by the agency; however, on the animal side, turn-around time is on the order of 300 days ostensibly because of staffing problems. Unfortunately, although CVM has had an increase in its budget and plans to increase their staff for 2015, Dr. McChesney indicated there are around 72 food additive petitions (FAPs) at CVM (presumably CVM is actively working on them) and he expects there will be considerably more in 2015. Dr. McChesney does not foresee any processes moving faster at CVM, which is anything but surprising news.
CVM is proceeding with a triage of AAFCO Official Publication “Ingredient Definitions” to determine which may fit into the mold of GRAS affirmations and which are suitable as FAPs. CVM feels adequate specifications may be available from AAFCO and safety data either in the scientific literature or from producers. Richard TenEyk, President of AAFCO, made an unequivocal statement that GRASes (regardless of status with CVM) will not be included in the AAFCO Official Publication (OP). CVM is still participating in the AAFCO definitions process and has volunteered to extend the MOU with AAFCO to continue the process for another two years (see above).