Preparing for FDA's Review of Animal Food Ingredients

Photo © iStockphoto.com/mihtiander

For decades, the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) has been the comprehensive guide to ingredient definitions for pet food and animal feed. Amid the hodge-podge of different state and federal ingredient listings, the OP is often treated as the go-to compendium of approved ingredients for animal food, both in the United States and in many foreign countries.

“We describe it as the one-stop place for feed labeling,” says Richard Ten Eyck, ingredient definitions chair, AAFCO. “All of the model regulations, all of the state contacts, all of the common names.”

But with FDA’s Center for Veterinary Medicine (CVM) reviewing the entire OP as part of a 2007 law to ensure the federal government has its own comprehensive ingredient listings for animal food, many ingredients in the OP are facing a new level of scrutiny. Hundreds of the 900-plus ingredients in the OP currently lack federal standing, even if they have been approved by state legislatures.

FDA’s goal is to assign a federal legal definition to as many of the OP ingredients as possible, but for those ingredients lacking the information to be considered generally recognized as safe (GRAS) or approved food additives, the burden may be on animal food ingredient firms to make sure their ingredients have the necessary profile to stay on the market.

Fortunately, there are a few actions a company can take proactively to increase the chances of its ingredient earning federal approval before FDA comes knocking.

Why is FDA Reviewing the OP?

AAFCO’s OP is considered by many to be the authoritative resource for ingredients in pet food and animal feed (it is called the Official Publication, after all). So it may come as a surprise that many of the ingredients in the OP are not currently federally compliant.

Until 2007, CVM regularly exercised “regulatory discretion” toward the ingredients in AAFCO’s OP, according to George A. Burdock, PhD, founder, Burdock Group (Orlando, FL). This meant that new ingredients could be accepted into the OP without either a feed additive petition or GRAS affirmation from FDA. And for more than 50 years, it was AAFCO’s OP that was the model for many U.S. state laws regarding animal food ingredients.

Roughly half of the more than 900 ingredients in the OP currently have no federal standing as a result of FDA’s “regulatory discretion” policy, which has largely left it up to the states to approve animal food ingredients, says Burdock. And with FDA taking such a hands-off approach, it’s AAFCO’s OP that has become the definitive guide to which ingredients are approved for use. Approved ingredient listings can vary from state to state, and FDA has its own GRAS and approved food additive listings. The OP is meant to bring all those different lists together, find the common ground, and maintain a single unified list of approved animal ingredients, says Burdock.

“The state laws that are on the books essentially recognize the AAFCO definitions and the AAFCO language,” says AAFCO’s Ten Eyck. “FDA has their set of rules that they have to follow, and AAFCO has served a useful purpose in there. The states aren’t cookie cutter to each other, and the federal law is not cookie cutter to the states, so AAFCO has served as the ‘how are we going to make sense of this and only have to do it one way.’ They kind of answered the grey area questions the industry had.”

However, FDA’s relatively hands-off approach to the animal food industry began to change around 2007, when an outbreak of pet deaths from contaminated food prompted a public outcry for greater federal oversight of the industry. In September 2007, the Food and Drug Administration Amendments Act (FDAAA) of 2007 was signed into law, which required FDA to establish its own ingredient standards and definitions for pet food. A few years later, FDA began its review of the OP.

While the review process takes place, FDA currently has a memorandum of understanding (MOU) with AAFCO that effectively maintains the status quo for now. For instance, under the MOU, AAFCO will continue to maintain definitions of the various feed ingredients and work with FDA to address any requests for new feed ingredients or requests to modify an existing feed ingredient definition. The arrangement will likely be renewed until FDA finishes creating its own ingredient standards, or potentially tweaked as the process nears completion.

“I expect that it would be extended as long as we need to, until we come to the place where we have a new process in place so that all of the ingredients will fit under the legal framework of the Federal Food, Drug, and Cosmetic Act,” says Sharon Benz, PhD, Division of Animal Feeds, CVM, FDA.

So the MOU may keep up business as usual until FDA finishes its review of ingredients in the OP, but then what?

FDA’s Methodology

Of the more than 900 total ingredients in the OP, Benz estimates that around 400 already have some legal standing under the Federal Food, Drug, and Cosmetic Act as either GRAS or food additives. The challenge now before FDA is figuring out what to do with the rest.

“We’re looking at the ingredients that don’t meet either of those two categories,” says Benz. “We went through and we did a rough count and we expect there’s probably about 500 ingredients or so that we have to address. And we’ve been doing it in the most efficient way possible.”

It’s been at least two years since FDA first began going through the OP on a section-by-section basis, and Benz says they have “gotten through quite a number” so far. However, it’s difficult to predict when the process will be complete.

“It’s a very time-consuming process-very resource intensive. As always, it depends on the continuing availability of resources to complete the task,” says Benz.

But with so many ingredients facing the complex and potentially difficult prospect of submitting a GRAS petition or food additive petition, ingredient firms may understandably be concerned about the entire transition. Benz says they shouldn’t be.

“We’re taking the burden upon ourselves to go through the book and to evaluate the information on the ingredients there and determine which ones are GRAS. If they fit into the GRAS category, if they meet that standard, then we will publish a regulation. We will put the information in a docket, make it available to the public, and publish the regulation saying they’re GRAS,” says Benz. 

 “For others that may not have the information in the public domain that GRAS requires, we may have that information in our files that it meets the food additive standard. So again, we’re going to take the burden on ourselves to write a food additive approval package and publish that for public comment, and so we will make these legal food additives,” says Benz.

It’s important to note that these ingredients would only receive GRAS or food additive status specifically for use in animal food products, not human food.

“I expect that there’s going to be a small few that we will not have the information to either make a GRAS determination or do an approved food additive, and for those ingredients we’re going to reach out to the industry and work with them so that we can get the information that we need to get them approved as food additives,” says Benz. “FDA is doing a lot of work in this respect.”

Not All Smooth Sailing?

But ingredient firms may not want to sit back and relax just yet. George Burdock believes the demanding criteria for FDA’s GRAS program could mean many ingredients don’t make the cut.

“FDA has taken the OP and they’ve decided there’s about 500 substances in the OP that are not legitimate,” says Burdock. “They think there’s 250 of them that may be GRAS and maybe another 100 or 200 that need a food additive position. And the others, it’s not clear what their fate would be. How is FDA going to declare these things GRAS, these 250? Because there’s, by and large, very little information on these things.”

According to Burdock, many of the ingredients in the OP may need to have additional published studies in order to build the necessary research profile for FDA’s GRAS affirmation. Oftentimes, the studies need to be targeted on specific species and intended uses of animal (beef cow vs. breeding cow), and it can be difficult to find journals that publish studies on animal food ingredients, says Burdock. The entire process could be costly and time-consuming.

However, neither FDA’s Benz nor AAFCO’s Richard Ten Eyck believe the change will present substantial difficulties for most suppliers.

“We do not intend to disrupt the industry with this process,” says Benz. “I don’t see how it will make it more difficult.”

Another potential hurdle lies in the comment period for ingredients that are granted GRAS affirmation by FDA. Ingredients that are being considered for a GRAS affirmation by FDA are published in the federal register for a public comment period, and Burdock thinks rival companies could potentially submit comments for a competitor’s GRAS petition during this period just for the sake of throwing up a roadblock to slow down the affirmation process.

Being Proactive

Whether FDA accepts an animal food ingredient right away or comes back with a request for more information, ingredient firms can act ahead of time to increase the likelihood of a smooth transition. Most of the OP ingredients are already in line with the state listings, and one way to win federal approval may actually be to obtain a GRAS affirmation independent of FDA.

“The proactive companies-and we’re dealing with some of them-they’re going ahead and getting their product GRAS [affirmed] and they’re not notifying FDA,” says Burdock. “So when FDA comes around and says ‘Alright, this material is not approved for use,’ they’re going to pull out their GRAS and say it’s compliant with federal law. And because it’s listed in the OP, it’s already compliant with state law. So they’ll be able to continue in business with that ingredient.”

There are two advantages to getting a third party or self-GRAS affirmation without notifying FDA. For one, it means ingredient firms can possibly avoid the problem of competitors submitting challenges during the public comment period because only the FDA GRAS affirmation process requires public comment.

But it could also prevent freeloading companies from reaping the benefits of the companies who actually pay for the GRAS affirmation process. Since FDA’s GRAS affirmations are made public while self-GRAS affirmations can remain private, rival companies would have much harder time piggybacking off of a competitor’s GRAS affirmation if it is done independent of FDA.

“What a lot of folks are afraid of is if they GRAS something, these other guys that don’t want to spend any money are going to piggyback on their GRAS,” says Burdock. “If a consortium of individuals gets together, forms an ad hoc committee, gets something GRAS [affirmed] because they pool their money, they can keep the GRAS and there’s no necessity to publicize.”

In that case, less proactive companies would not be able to benefit from the foresight of their competitors and would have to pay for a separate GRAS process.

“The people that are going to be proactive are the ones that are going to be able to stay on the market,” says Burdock. “The people that fool around, sit on their hands, and don’t do anything are going to lose market share.”

And don’t forget, FDA’s Benz reminds, the FDA-affirmed GRAS or food additive programs are still viable routes for ingredient firms looking to be proactive. She adds that CVM “would be very happy to talk with them and work with them to figure out what process would be best.”

The Future of the OP

However many years it takes, once FDA’s review of the pet food and animal feed ingredients is complete, will the OP still play an important role in clearing up the gray areas in the industry? Absolutely, says AAFCO’s Ten Eyck.

“Really none of that functionality is going away because the states aren’t changing their laws,” says Ten Eyck. He adds that just because FDA is creating its own standards, it doesn’t mean the state lists will become obsolete. There may still be discrepancies between the state and federal listings that the OP will strive to clarify. “The OP will continue to be the reference material that the states are going to use.”

FDA’s Benz thinks that by bringing the OP in line with federal law over the course of FDA’s review, it will put “it in a more positive light than it currently is.” She expects the OP to “continue to play a very important role in animal feed regulation.”

And one of the biggest appeals may well remain the “one-stop” convenience of the OP.

“Even as FDA develops food additive regulations, we’re grabbing the name of those and bringing them into the book as common names, so you don’t have to go read the federal register every week,” says Ten Eyck. “AAFCO’s going to pick those up and you’re going to be able to pick up our book online, do a quick search, and go ‘Oh, ok, that’s what I call it.’ The convenience factor will remain there.”

In short, the OP will continue to be used as a convenient and comprehensive reference material, says Ten Eyck.

Sidebar: FSMA and Animal Food

FDA’s Food Safety Modernization Act (FSMA) will also bring two other big changes to the animal food and supplement industries: the introduction of federal good manufacturing practices (GMPs) and a new foreign supplier verification program for ingredients. Until now, there were no federally mandated GMPs for animal feed.

“It will be the first time that there will be a nationally defined and consistent set of good manufacturing standards or requirements for the pet food industry,” says Bill Bookout, president, National Animal Supplement Council (Valley Center, CA), which represents the animal supplement industry. He adds that the industry is currently “not absent or devoid of good manufacturing practice standards,” and that companies following NASC’s GMP requirements should already be in good shape for the new GMPs under FSMA.

The foreign supplier verification program may actually be the more difficult FSMA change to implement, according to Ray Matulka, PhD, director of toxicology, Burdock Group (Orlando, FL). The program will likely require a much greater degree of scrutiny for animal ingredients coming from abroad than was currently in place, says Matulka.

“All of it has to be verified that those foreign ingredient manufacturers are meeting the same requirements of GMP and all of the other hazard analysis requirements necessary here in the states,” says Matulka. “So that’s going to be a big verification nightmare for a lot of these pet food companies.”

The final rules of FSMA’s foreign supplier verification program will be announced on October 31.

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Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com