FDA Lacks Authority to Extend Bioterrorism Regulations to Food Packaging Industry
By Keller and Heckman LLP’s Packaging Practice Group
Despite a lack of congressional authority, the U.S. Food and Drug Administration (FDA) has proposed extending its bioterrorism regulations to food-contact materials -- specifically, the regulations requiring prior notice of imports and registration of food facilities.
Food-contact materials are brought within the reach of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act") by virtue of the statute's adoption of the broad definition of "food" found in Section 201(f) of the Federal Food, Drug, and Cosmetic Act (FFDCA). There, "food" is defined as:
"(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."1
This definition, in conjunction with the definition of "food additive,"2 provides a basis for FDA to assert regulatory authority over any food-contact materials that are also food additives.
In its proposed regulations, FDA listed examples of products that it considers to be covered by the definition of "food." The list identifies "substances that migrate into food from food packaging and other articles that contact food" as "food" for purposes of the regulation, making it clear that the agency intends for the provisions to be extended, at least to some degree, to food packaging.
Intent to Exclude Packaging Is Clear
Section 307 of the Bioterrorism Act states that the agency must be given prior notice of the import of any "article of food." As explained above, use of the term "article of food," coupled with the definition of "food" in the FFDCA, could lead to an interpretation that the prior notice of import provision was meant to include food-contact materials.
Because Section 307 of the Bioterrorism Act did not include language specifically excluding food-contact materials, The Society of the Plastics Industry, Inc. (SPI) sought clarification from Congress that packaging materials were not intended to be subject to this provision. As a result of this effort, the Joint Explanatory Statement of the Committee of Conference for the bill included the following language in the legislative history regarding the provision governing prior notice of imported food shipments:
The Managers intend that the requirements of this section [import notification] should not be construed to apply to packaging materials if, at the time of importation, such materials will not be used for, or in contact with, food as defined under section 201 of the FFDCA. Nothing in this section shall be construed to alter or amend the regulatory treatment of food packaging materials or food contact substances under the FFDCA.
A subsequent entry into the Congressional Record on May 24, 2002, by the bill manager in the House, Rep. John Shimkus (R-Ill.), further clarified congressional intent:
Mr. Speaker, in addition to my statement for the record on May 22, 2002 during floor consideration of H.R. 3448, let me clarify that language included in the Conference Report regarding Section 307 as it relates to food packaging materials. Section 307 dealing with prior notice of imported food shipments should not be construed to apply to food packaging materials or other food contact substances if, at the time of importation, they are not used in food.
Thus, Congress expressly indicated that food-contact materials not yet containing food were not meant to be subject to the provision. FDA clearly disregarded this intent by proposing to require advance notice of importation of these materials.
The terminology used by Congress in the facilities registration provision of the Bioterrorism Act differs slightly from the language in the import notification provision, but nonetheless reflects a lack of congressional intent to include facilities manufacturing or holding food-contact materials.
Specifically, Section 305 of the act states that facilities that "manufacture, process, pack or hold food for consumption in the United States" will be required to register [emphasis added]. It is noteworthy that this language differs from the term "article of food" used in the provision requiring prior notice of imports.
Discussions with congressional staff and others involved in developing the Bioterrorism Act make it clear that Congress intended the phrase "food for consumption" to refer to edible food only, not "food" within the full scope of the meaning under the FFDCA (i.e., including food-contact materials). Although Congress did not provide legislative history on the meaning of "food for consumption" under the facilities registration provision, as it did for "articles of food" under the notice of import provision, Congress likely assumed that nobody would misconstrue the meaning of "food for consumption" as applying to anything but edible food. Further, since Congress indicated explicitly that "articles of food" do not include food-contact materials for purposes of import notification, it is apparent that "food for consumption" should not be given a broader interpretation.
Another indication that Congress did not have food-contact articles in mind as triggering facilities registration under the Bioterrorism Act is the legislators' reference to the food categories in 21 C.F.R. § 170.3. The Bioterrorism Act states that FDA may require each facility to submit the general food category, as identified under § 170.3, of the food manufactured, processed, packed, or held at the facility. In fact, FDA followed the instruction of Congress and included the categories from § 170.3 as a mandatory field on a draft of the registration form. Notably absent from § 170.3, however, are categories for food-contact materials.
Materials Subject to Regulations Unclear
The terminology used by FDA in the proposed regulations could be interpreted to mean that any material used in the production of food packaging is subject to the registration and import notification requirements. However, FDA has indicated that only certain packaging materials are intended to be included.
In particular, FDA's proposal states that "substances that migrate into food 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." Nonetheless, the terms "immediate food packaging or components of immediate food packaging" potentially cover a vast array of products -- including plastic resins, glass, paper, metal, rubber and textiles, and many other materials, such as monomers, colorants, lubricants, preservatives, plasticizers, catalysts, antioxidants, defoaming agents, emulsifiers, and adhesives -- that are used in the production of food packaging.
Subsequent to the issuance of the draft regulations, FDA officials, speaking at a meeting at the National Food Processors Association, attempted to clarify further which packaging materials would be subject to the requirements. FDA specifically indicated that the intent of the proposal is for the rules to cover only "finished" packaging that will be in direct physical contact with food.
As an example, FDA explained that the regulation would apply to liners for cereal boxes, but not the boxes. Further, in response to a question posed by a meeting attendee, FDA indicated that the regulations would not cover polymers, additives, or monomers, but only the "immediate" food packaging made from such components. Thus, it seems that the regulations were not really intended to apply to the many other components of food packaging. However, the current language of the proposed regulations does not limit the coverage of the regulation as FDA apparently intends.
Benefits Outweighed by Burdens
The stated objective of the Bioterrorism Act is to "expand FDA's powers to prevent and respond effectively to terrorist threats against the food supply." While Congress and FDA are to be applauded in taking steps to protect the food supply from terrorist acts, a cost/benefit analysis must be applied to any proposal. Regardless of whether the requirements ultimately apply only to finished food packaging, they will impose a significant burden on the companies involved in the industry. These burdens are disproportionate to any minimal reduction in risk and will provide no significant protection against terrorism.
The registration requirement, in particular, would apply not only to the facilities that manufacture the products, but also to the warehouses where they are stored. Large companies, particularly multinational entities, will have to spend an inordinate amount of time simply identifying the facilities that will need to be registered and putting in place mechanisms for meeting their obligations, including the updates FDA proposes to require.
Further, if facilities that manufacture or hold food-packaging materials are included in the registration provisions, the provision would cover many facilities that are principally non- food industry suppliers, but that also have a small business in supplying materials used in food packaging. Similarly, independently owned warehouses that store small amounts of materials used in food packaging would have to be registered, and some warehouse owners may not even be aware that they are storing food-contact materials. Furthermore, materials used principally in non-food applications often have food-contact uses, which may not be known to every facility that handles the materials.
With regard to the importation of food, many such materials are introduced into the market through distributors, and the manufacturer frequently does not know the end use. Distributors or other importers of these materials also may not be aware of their customers' intended applications. Accordingly, they may not realize that they have a notification obligation, or may have difficulty determining which shipments require notification. As drafted, the proposed regulation probably would necessitate notification for all shipments of materials that have any known food-contact applications. This would impose an enormous burden on industry, and require a huge educational effort by FDA to inform companies of their obligations.
Logistics aside, FDA has failed to explain how including food-contact materials in the regulations would deter the intentional contamination of food or assist the agency in determining the source and cause of contamination. In estimating the benefits of the proposed regulations, FDA discusses five outbreaks of foodborne illness from accidental and intentional contamination of edible food, but there is no mention of food-contact articles being related to any such occurrences. It seems unlikely that terrorists would attempt to contaminate food indirectly by tampering with empty packaging.
Perhaps most importantly, requiring registration of food-contact materials and prior notice of importation of these products would divert FDA's attention and resources from activities directed toward more immediate food security risks.
121 U.S.C. §321(f).
2Section 201(s) of the FFDCA defines "food additive," in part, to include "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food." 21 U.S.C. § 321(s). The definition specifically includes substances intended for use in packing or packaging food. Id.