New FDA Regulations are All About the Garnish

Columns - Legal Briefs

How to dig into the FDA’s Produce Safety Rule via the burger.

February 8, 2021

Food manufacturers may be wondering how the Food and Drug Administration’s (FDA) recently enacted produce safety regulations affect them and their consumers. Consumers themselves, well aware of the increasing number of outbreaks involving produce traditionally thought of by consumers as safe to eat (think spinach, romaine lettuce, and more recently, red onions), want to know how food manufacturers are protecting them, and rightly so.

Through the produce regulations, which are at Code of Federal Regulations, 21, 112.1-112.213, the FDA has attempted to tackle the growing number of these kinds of outbreaks, potentially arming the food industry with an additional weapon for use in the constant battle with foodborne illness.

The regulations, broadly speaking, require farms of a certain size to develop processes relating to employee hygiene and training, agricultural water, biological soil amendments (compost, manure and the like), buildings and equipment. It’s all in an effort to decrease the risk of contamination of produce during growing, harvesting, packing and holding. But what does that mean for food manufacturers?

The simplest way to get a good overview of the regulations is to consider them in the context of one of life’s simple pleasures: a burger and fries.

The fries are an easy one. For reasons that should be fairly obvious, the regulations don’t apply to produce that is rarely consumed raw. The FDA has provided an exhaustive list of this kind of produce.

But what about those all-important trimmings — tomatoes, lettuce, onions and pickles? With the arrival of the produce regulations, can food manufacturers expect, and even demand, a greater level of safety and accountability from their suppliers?

The short answer is yes. Lettuce, tomatoes and onions are all covered produce under the act. (Pickles are treated differently, and we’ll get to them shortly.)

The simplest way to get a good overview of the regulations is to consider them in the context of one of life’s simple pleasures: a burger and fries.
© Mara Zemgaliete | Adobe Stock

Even though the regulations cover the typical garnishes, whether or not they provide food manufacturers with greater guarantees of safety and accountability really depends on who is growing, harvesting, packing and holding the produce.

That’s because the regulations only apply to farms, which are generally defined as those establishments that actually grow and harvest the produce. Facilities that only pack and hold produce must follow the new regulations if they are majority owned by a farm that grows and harvests the produce. But non-farm packing and holding facilities can choose between following the new regulations or following current good manufacturing practices. Establishments that only hold or transport produce are not required to follow either.

What’s more, not all farms are covered under the new regulations. Farms that on average sell less than $25,000 per year of produce aren’t covered by the regulations at all. And farms that sell an average of less than $500,000 of food each year may seek an exemption from the regulations if the amount of produce they sell each year direct to consumers or to restaurants and retail establishments within the same state or less than 275 miles away exceeds the amount of all other food sales.

The smaller and more local the farms, the less likely it is that they must follow the new regulations. If produce is packaged and held by a middleman, they may not have to follow the new regulations either.

So how does a food manufacturer develop the knowledge necessary to have some power over what enters its facility, and over what risks to accept in sourcing produce? Well, if produce comes directly from a farm covered under the new regulations, the manufacturer should make sure that its supply contract requires the farm to provide regular certification that its produce has been grown, harvested, packed and held in compliance with the regulations.

The same goes for produce coming from a packing and holding facility that is majority farm owned. But even if the produce comes from a non-farm packing and holding facility, manufacturers can seek reassurance of safety in several ways. They can require certification that suppliers comply either with the produce safety regulations or with current good manufacturing practices. If manufacturers have strong bargaining power over non-farm suppliers, they might even consider requiring that the supplier voluntarily comply with all or some of the produce safety regulations. Or manufacturers could require that the supplier obtain certification from the grower that the produce was grown and harvested in compliance with the produce regulations or (for non-covered or exempt farms) that the grower otherwise complied with current good manufacturing practices.

Even if produce comes from non-covered or exempt farms, manufacturers may still consider asking the farm to follow basic practices that mitigate the risk of contamination, such as making bathrooms and handwashing stations easily accessible.

At this point, you’re probably asking, “But what about the pickles, Jennifer?”

Under the rules, covered produce does not include that which will receive commercial processing that adequately reduces the presence of microorganisms of public health significance. Examples of such commercial processing include processing in accordance with the requirements of the FDA’s acidified foods regulation found at CFR, 21, 114, which governs pickles among other foods.

Although the farm that grew the cucumbers may not have had to comply with the produce regulations, the pickle producer must still comply with regulations applicable to the pickling process. Food manufacturers should ensure that their supply contract with their pickle supplier requires the supplier to certify that the pickles were processed in compliance with the acidified foods regulation.

At a minimum, manufacturers should keep good records showing who grew, harvested, packed and held their produce, so that in the event of an outbreak of a foodborne illness, they can provide the FDA with essential information to help determine the source. Manufacturers should also ensure that their supply contracts contain provisions requiring suppliers to notify them whenever the suppliers have reason to suspect that produce may have become contaminated.

After all, a burger is only as good as its toppings.