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Bioterrorism Legislation Could Affect Converting Industry

On December 12, 2001, the House of Representatives overwhelmingly passed legislation expanding Food and Drug Administration authority to respond to bioterrorism.

H.R. 3448, the “Public Health Security and Bioterrorism Response Act of 2001,” is one of several bioterrorism bills. While it is intended to give FDA additional tools to assure the nation's food supply remains as safe as possible, some provisions might be interpreted to apply to packaging in ways that could be burdensome, mainly due to definitional aspects.

H.R. 3448 and other draft bioterrorism bills would amend the Federal Food, Drug, and Cosmetic Act (the FFDCA). Thus, the term “food” in the legislation is governed by the general FFDCA definition. Section 201(f) of the FFDCA defines “food” 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.” (All emphasis in this article has been added.) Section 201(s) of the FFDCA defines a “food additive” as: “…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 (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food….”

Reading the two definitions together, one could conclude packaging materials that are “food additives” also are “food” under FFDCA. This creates a risk packaging materials could be subject to FDA's expanded powers under H.R. 3448.

Section 302 of H.R. 3448, e.g., would amend Section 304 of FFDCA to authorize (not require) FDA to detain for up to 30 days “[a]n article of food” if there is “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death….” “Article of food” suggests edible food, not packaging. Nevertheless, there is some danger of misinterpretation, especially since other FFDCA provisions giving FDA enforcement authority over “food” are interpreted to apply to “food additives,” including packaging materials that are so-called “indirect food additives.”

Section 304 references food packaging. This section would authorize FDA to impose new record-keeping requirements “as may be necessary to trace the source and chain of distribution of food and its packaging” to “address credible threats of serious adverse health consequences or death….” While probably intended to address tampering, traceability requirements could be applied to food packaging materials more generally.

H.R. 3448 also has provisions that would impose new facility registration requirements and require at least 24 hours advance notice of importation. The registration provision (Section 305) applies only to plants “engaged in manufacturing, processing, packing or holding food for consumption in the United States….” The provision pertaining to advance notice of importation, however, refers to “article[s] of food,” as Section 302 does. Again, while misinterpretation is possible, the intent appears to cover food products, not food packaging.

Other pending bills potentially implicate the packaging industry; some other versions of proposed bioterrorism legislation expand FDA's authority even more. Senator Clinton's bill S. 1551, “Protecting the Food Supply from Bioterrorism Act,” would give FDA new authority to recall “unsafe food,” again, with a potential definitional impact on packaging materials. The food industry is opposed to giving FDA recall authority, and this feature is not part of other bills.

Bioterrorism legislation likely will have been adopted by the time you read this. We expect legislation should track H.R. 3448, and not more extreme measures, but converters should review any final version for implications to their operations.

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