Proposed bioterrorism regs to cover packaging materials for foods, supplements - Regulatory Analysis - US FDA food industry proposals

Food & Drug Packaging, April, 2003 by George Misko

In the interests of food security, the Food and Drug Administration (FDA) has proposed regulations that will require food companies--and their packaging material suppliers--to register with the Agency and notify it when products are imported to the U.S. These regulations would implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Under the Act, facilities must register by Dec. 12, 2003, even if the final regulations are not in place. FDA intends to have a final rule issued by Oct. 12, 2003, but, in any case, intends to have both an electronic and paper registration system in place by then. Import notification must also begin by Dec. 12.

According to the Agency, the registration requirements will help FDA determine the location and cause of a threatened or actual terrorist attack on the U.S. food supply. The import notification requirements are to help ensure the safety of imported food products before they enter U.S. markets.

How does this affect you? Registration and other requirements that will affect your suppliers may result in increased costs. And, if you buy packaging materials from overseas, your company will be the one responsible for complying with FDA's import notification requirement.

Surprise! Surprise!

Including packaging materials suppliers came somewhat as a surprise in light of the provisions of the Act and its legislative history.

The registration provisions in the Act apply only to certain facilities that "manufacture, process, pack or hold food for consumption in the United States" (emphasis added). The term "food for consumption" cannot reasonably be interpreted to extend to packaging materials.

Similarly, the legislative record was made clear that the scope of the import notification requirement, intended to cover "articles of food," did not include food packaging materials.

The regulations will impose obvious burdens on all such manufacturers and users of products who will be required to register each facility in which they may have product on hand, as well as to notify FDA every time they intend to import a packaging material into the U.S.

Of course, most packaging material suppliers would be willing to shoulder this extra burden if they thought some good could come out of it. But that's the rub. It's unknown what useful information FDA will get out of all of this.

Who must comply

The registration requirements would apply to "owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States."

The regulations would cover all facilities that manufacture food and animal feed products regulated by FDA (with the exception of meat and poultry slaughterhouses that are regulated exclusively by the U.S. Department of Agriculture). This includes storage locations such as warehouses, in addition to manufacturing facilities. The proposal excludes farms, restaurants and other retail and non-profit food establishments from the registration requirements.

Products covered include dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives. The proposed regulations define "food" to include "substances that migrate into food from food packaging and other articles that contact food." In the preamble, the Agency explains that substances migrating from food packaging include "immediate food packaging or components of immediate food packaging that are intended for food use. Outer food packaging is not considered a substance that migrates into food."

The Bioterrorism Act also requires purchasers and importers to notify FDA no more than five days before arrival and no later than noon on the calendar day before a food product arrives at a border crossing or a port of entry. The notice will be submitted electronically through a 24-hour Internet-based system. The Agency anticipates it will receive an average of 20,000 such notices each day.

Which packaging materials?

Needless to say, including food packaging materials in the proposal could result in the registration of just about every packaging material manufacturer in the U.S. and abroad, and notice of importation of literally hundreds of thousands of shipments of such products a year.

Since publication of the proposed regulations, however, the Agency has tried to clarify who the registration and importation requirements

were supposed to apply to. According to FDA officials, the proposed regulations are intended to apply to manufacturers and importers of finished food packaging articles that directly contact food. Polymers, resins, additives and similar items that are used in packaging but are not finished articles, would not be covered.

Although that clarification is somewhat helpful, there is still a lot of gray area. For example, it is still not clear whether the Agency would intend the regulations to cover materials, such as films, that are imported in roll form, but still must go through further processing to make a finished food packaging material.