FDA guidelines vs. regulations

Sometimes, the legal developments that may seem irrelevant to any individual packager may contain the seeds of important legal concepts. I have one such here. Stick with me, and I believe you will see the full significance of a seemingly obscure announcement by the U.S. Food & Drug Administration.

The executive summary is as follows. The government issued draft guidelines to help some food businesses operate more safely. However, some critics complained that these shouldn't be mere guidelines; they should be regulations with penalties attached for violations. But you must put yourself in FDA's shoes and ask, "Would I really want to make regulations out of these guidelines?"

We start by noting that FDA recently issued draft safety guidelines for companies that process and package fresh-cut fruits and vegetables. Not fresh, but fresh-cut, that is, fresh produce that has been processed by "peeling, slicing, chopping, shredding, coring, trimming or mashing, with or without washing or other treatment, prior to being packaged for consumption," says FDA. As examples, FDA offers "shredded lettuce, sliced tomatoes, salad mixes (raw vegetable salads), peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melons, sliced pineapple and sectioned grapefruit."

Says FDA, "With $12 billion in annual sales in the past few years, the fresh-cut sector of the produce industry is its fastest-growing segment." But, it adds, "From 1998 to 2004, forty foodborne-illness outbreaks were associated with the consumption of fresh produce. Of these produce-related outbreaks, twenty-five percent implicated fresh-cut produce."

So FDA's guidance document gets down into the nitty-gritty of the operations of those companies that pack fresh-cut fruits and vegetables, and offers specific suggestions on how to perform these processes, addressing 1) personnel health and hygiene; 2) training; 3) building and equipment; 4) sanitation operations; and 5) controls, from product specification to packaging, storage and transport. It also recommends that processors put in place control systems like Hazard Analysis and Critical Control Points (HACCP).

The recommendations also focus on decreasing the potential for packaging to be a source of microbial or other contamination, such as setting packaging specifications; using a first-in-first-out rotation system for packaging; and labeling products with recommended storage instructions. The guidance also provides recommendations for using modified atmosphere systems, as well as guidance on the use of product shelf-life and "use-by" labeling.

The recommendations are not new and revolutionary in that many processors are already doing many or all of these suggested steps. However, the emergence of new and different products, and new processors, increases the need for clear guidance on how to pack these products safely.

Now, an analysis from the perspective of public policy and food regulation. As you might expect, a mere guidance document is not in all respects identical to a regulation. For one thing, guidelines don't set forth the one and only way to comply with a regulatory requirement. In fact, after years of wrangling, FDA was compelled to make that point explicitly on the guidance documents they issue. An inspector cannot claim you are in violation only because you fail to comply with a guidance document's recommendations. Instead, they have to find that your practices actually constitute a failure to comply with the law or regulations. Still, it's probably true that the easiest way to show an inspector that your practices meet regulatory requirements is to match the guidance document's recommendations.

On the other hand, if a regulation says to do something a certain way, and you don't, then that clearly is a violation, one that the inspector can add to his list of violations observed, and which might lead to more serious steps later.

So when critics complain that FDA has issued mere guidelines, their objection is based on the fact that the guidelines don't have "teeth." Only penalties, they say, provide industry with the incentive needed to get all or most members to comply, and provide the punishment for those who don't. Guidelines, they say, will not have the same effect, since some companies might feel free to ignore them.

Based on experience with similar patterns, I surmise that it's likely that FDA's thought process went something like this: "We want the producers of fresh-cut fruits and vegetables to reduce microbial contamination, and to do that, we want them to tighten their operations. We can list ways to tighten operations. But if we make a regulation out of it, first of all, we have to make a proposed regulation, publish it in the Federal Register, collect public comments, and then revise and publish the final regulation. This so-called notice-and-comment rule-making process takes months or even years, and ties up a lot of our people's time.

"On the other hand, if we issue a guideline, it will be in industry's hands as soon as we can publish it in draft form, so companies can start to implement the recommendations long before we issue the final version, even as we collect input on the draft."

Also, FDA may have thought: "Once the regulation is final and published, then we have to add it to the things we inspect for and cite companies for failing to follow. Nothing wrong with that, as such," says the agency to itself, "but once a regulation is in place, if aspects of it are especially tough to comply with or otherwise problematic for industry, we might find ourselves defending the rules in court."

All of this—notice-and-comment; working the new rules into enforcement practices; and possible court actions—takes a lot of FDA's energy and time. An agency would therefore typically be inclined to use all this energy and time on issues that really demand this level of attention, issues that are a high priority for protection of the public health.

Agencies struggle to match priorities and resources, which leads them to make some requirements mandatory, while it recommends others. Regardless of the mechanism chosen, FDA's goal is to reap effective fruits from its labors.

Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at [email protected], or by phone at 312/977-4647.