Regulatory Issues: Just what exactly is a food?

Less obvious are things like antimicrobials, ion exchange resins and lubricants such as mineral oil applied to food processing equipment

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Leave it to lawyers to impossibly complicate the meaning of the word food. This question -- what is food? -- recently has confronted many regulatory professionals trying to understand the scope of the Food and Drug Administration's bioterrorism regulations, particularly the facility registration and import notification rules.

If food is manufactured/processed, packed, or held at a facility, the facility must be registered with FDA. And if food is imported into the country, FDA must be notified of the shipment in advance. Therefore, the meaning of the term food plays a critical role in delineating the scope of these two rules.

FDA uses the same language to define the term food in each of the two rules. Essentially, food includes anything that falls within the pre-existing definition of the term food in the Federal Food, Drug, and Cosmetic Act (FD&C Act), but it does not include "food-contact substances," as defined in the FD&C Act, or "pesticides," as defined in the Federal Insecticide, Fungicide, and Rodenticide Act. So far, this seems clear enough.

The first small wrinkle is that foods regulated exclusively by the U.S. Dept. of Agriculture are not within the scope of the facility registration or import notification rules. Thus, if a facility is regulated exclusively by USDA under the Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act, there is no need to register that facility with FDA. Nor are these products subject to the import notification requirement.

Apart from the USDA wrinkle, the definition of food clearly includes all traditional food items, such as fruits, vegetables and snack foods. It also includes food ingredients and anything that qualifies as a food additive. Less obvious is the inclusion or non-inclusion of things like antimicrobials applied to processed food, ion exchange resins used during food processing and lubricants such as mineral oil applied to food processing equipment.

A methodical approach can help determine whether these not-so-obvious examples qualify as food. First, does the substance fall within the definition of food in the FD&C Act? If so, is it exempt as a food-contact substance or as a pesticide? Answering these questions is not as easy as one might expect.

FDA excluded food-contact substances from both the interim final rules for facility registration and import notification. In doing so, FDA references the definition of food-contact substance in section 409(h)(6) of the act: "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food."

Obviously covered by this language are things we would commonly recognize as food-contact substances: plastic beverage bottles, plastic meat wrap, the resin used to manufacture those articles, and other substances used in the manufacture of those articles such as antioxidants, colorants, monomers, catalysts, and defoaming agents. The agency also made it clear food-contact substances include, for example, boiler water additives, ion exchange resins, certain antimicrobials added directly to food, and machinery lubricants that contact food incidentally.

What these substances have in common is, generally speaking, they do not perform a technical effect on the finished food, even if they serve a technical effect during the processing.

It might be argued FDA has the flexibility to interpret the term food-contact substance differently for purposes of accepting food-contact notifications and for implementing the Bioterrorism Act. This may be true, but it seems reasonable to assume FDA will apply a single definition to this statutory term unless the agency clearly indicates otherwise.

FDA's statements on the subject seem to reflect an intention to exempt all antimicrobials from the facility registration and import notification rules. Furthermore, antimicrobials that are applied to processed food for the purpose of a one-time antimicrobial treatment, without an ongoing technical effect in the finished food, seem to be eligible for treatment as food-contact substances. It does not appear, however, FDA intends to exempt preservatives, such as sodium benzoate, from the two rules, because these substances have an ongoing technical effect in food.

From a practical standpoint, some who are grappling with these issues might decide to err on the side of caution and comply with the two rules. As I said up front, answering some of these questions is not easy.

David Joy is a partner at the Washington, D.C., law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.

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