AAFCO pondering new approach for ‘human grade’ claims

Several issues with the current guidance could be eased with a proposed new, verification avenue.

AAFCO is considering third-party verification as an option for human grade claims as it revisits current substantiation methods. | Andreykuzmin, Dreamstime
AAFCO is considering third-party verification as an option for human grade claims as it revisits current substantiation methods. | Andreykuzmin, Dreamstime

The 2017 Association of American Feed Control Officials (AAFCO) Annual Meeting was held on August 10–12, in Bellevue, Washington, USA. One significant item brought forth for discussion during the Pet Food Committee session was a proposal of a new approach for substantiation of "human-grade" claims. As more and more pet food companies are considering the feasibility of the claim on their product labels, it is clear that a more streamlined approach to substantiation is sorely needed. This new approach would rely on third-party certification of compliance with the AAFCO guidance for the claim.

Current approach and potential issues

The AAFCO "Guideline for Human-Grade Claims" was passed in 2016, and appears in the 2017 AAFCO Official Publication. This guidance was needed after the US Food and Drug Administration (FDA) indicated several years ago that it would no longer review documentation in support of the claim. With that announcement, the burden shifted to individual states to evaluate the veracity of the claim before registering the product in that state. Unfortunately, many states may neither have the inclination nor capacity to review such extensive documentation as required by the AAFCO guideline. Their desks are typically piled high with registration applications, label reviews, inspection and tonnage reports, etc., so adding reams of data on top of that in support of one claim for one company is asking a lot of most regulators.

Further, because many different entities are now reviewing the documentation instead of just one, interpretation of the requirements as stipulated by the AAFCO guidance varies. Anyone in the pet food industry who has submitted labels for registration knows that each state may have a different take on things, and what is acceptable to some if not most feed control officials may be objectionable to others. Same is the case for "human-grade" substantiation.

Especially since this guidance is so new, many states may not even be sure what information they really need to make a proper assessment. As a result, a dossier of documentation in support of the claim may be all one state needs, but another may consider that same packet of information to be insufficient, and would require different or additional documentation prior to completion of the registration process. 

The reasoning behind the proposed new approach

The new approach as proposed would provide for verification of the claim through a third party, namely, the Quality Assessment Division within the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS). The mission of AMS is different from other components of USDA, such as the Food Safety and Inspection Service or the Animal and Plant Health Inspection Service, which oversees inspection of meat and poultry for human consumption and helps prevent the introduction of foreign animal diseases into the US, respectively. Rather, the mission of AMS is to administer programs that create marketing opportunities, as well as to provide the industry with services to ensure the quality and availability of products for consumers.

Perhaps the most well-known program administered by AMS is the National Organic Program, which oversees all organic claims on food and other agricultural crop labels. However, under its Process Verified Program (PVP), it will also offer verification services for specific practices and processes, such as proof of adherence to a recognized standard that is not otherwise required. So, for example, if a company wanted to assure the consumer of the veracity of a specific claim, such as "humanely harvested" or "sustainable," a means by which repeatable, feasible and factual process points are verified, via both a desk audit and an on-site facility inspection, could be set up by AMS.

This type of program can easily be put in place for AMS to verify that the pet food company is in compliance with the AAFCO guidance for human-grade claims; i.e., that the product is manufactured in a facility permitted to produce human food in accordance with FDA's Current Good Manufacturing Practices (Title 21 Code of Federal Regulations Section 117), and that all ingredients and the resulting product are in fact handled, stored and shipped in a manner so that it remains fit for human consumption. Assuming the process was verified, the manufacturer would then receive appropriate documentation from AMS, which it could make available to the state feed control officials as needed.

If this option came to fruition, companies could send each of the states a single page, instead of a sizable number of documents in support of the claim. Also, the documentation would be reviewed only once, and presumably in a manner consistent across the industry. This would save a lot of time and trouble for manufacturers. It would also be of great benefit to feed control officials, in that they would no longer have to review stacks of documentation every time some company submitted a label bearing a human-grade claim.

More input being gathered before a decision is made

However, this is not a done deal. Before proceeding, AAFCO intends to poll regulators as to whether they are willing to accept third-party certification in lieu of the approach now. Also, manufacturers must note that AMS does establish fees for its administration of programs of this nature. It is assumed that involvement in an AMS program would not be mandatory, though, so if a state or company did not wish to participate, there would still be an option of submitting the documentation as is currently done.  

 

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