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March 18, 2002 The Honorable W.J. "Billy" Tauzin Re: Concerns of The Society of the Plastics Industry Regarding the Potential Impact of H.R. 3448, the Public Health Security and Bioterrorism Response Act on Food Packaging Materials Dear Chairman Tauzin:: We write to you on behalf of The Society of the Plastics Industry, Inc. (SPI) to express concerns regarding the potential impact that H.R. 3448, the Public Health Security and Bioterrorism Response Act, could have on food packaging materials. We appreciate the opportunity to share these concerns, as well as the conference committee's time and consideration of these issues. SPI is a trade association representing the fourth-largest manufacturing industry in the United States. Many of SPI's 1,500 members are engaged in some aspect of the production of food packaging materials. Plastic packaging plays an important role in protecting the safety and quality of many food products. Therefore, SPI is very concerned about the potential unintended consequences that some of the provisions contained in Title III of H.R. 3448, Amendments to the Federal Food, Drug, and Cosmetic Act, could have on the food packaging industry. In particular, SPI is concerned about the following provisions: I. Prior Notice of Imported Food Shipments (Section 306 of H.R. 3448, Section 535 of S. Amdt. 2692) The first provision that is of concern to SPI is Section 306 of H.R. 3448, which would amend Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to direct the Secretary of Health and Human Services (HHS) to issue regulations requiring manufacturers and shippers of articles of food to provide the Secretary of Treasury with information regarding the shipment prior to its import into the United States. The language used in this section refers to "an article of food," and the section does not contain a separate definition of "food" aside from the one already set forth in Section 201(f) of the FD&C Act which 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." 21 U.S.C. § 321(f). FDA has relied on the FD&C Act's definition of "food," in conjunction with the Act's definition of "food additive," to provide a basis for the Agency to assert regulatory authority over any food packaging materials that are also food additives. In light of FDA's view that "food" oftentimes includes food packaging materials, we believe that the prior notice of imported shipments provision could be broadly construed to apply to food packaging materials, as well as traditional articles of food. Our understanding is that this provision (and most of the legislation) is not intended by the drafters to apply to food packaging. However, it is our view that questions concerning this provision's applicability to food packaging materials should be clarified through the inclusion of language in the conference report indicating that the committee does not intend for amended Section 801 of the FD&C Act to apply to food packaging materials. II. Maintenance and Inspection of Records for Foods (Section 304 of H.R. 3448; Section 533 of S. Amdt. 2692) This section of the legislation would add a new Section 414 to the FD&C Act to broaden the existing requirements for requiring the maintenance and inspection of records for foods. Again, the language used in proposed Section 414(a) refers to "an article of food" that may pose a "threat of serious adverse health consequences or death to humans or animals." Therefore, as discussed above, we believe that the maintenance and inspection of records provision could be broadly construed to apply to food packaging materials, as well as traditional articles of food. Furthermore, proposed Section 414(b) would also amend the FD&C Act to allow the Secretary of Health and Human Services to "establish requirements regarding the maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food, as may be necessary to trace the source and chain of distribution of food and its packaging . . . ." However, there is no indication as to whether this provision is limited to food packaging once it becomes associated with the food, or whether it could also encompass each segment of the food packaging production process, even before the packaging becomes associated with the food. We believe that both of these issues could be clarified through the inclusion of language in the conference report indicating that the committee does not intend for new Section 414 of the FD&C Act to apply to food packaging materials that have not yet become associated with food. III. Registration (Section 305 of H.R. 3448; Section 534 of S. Amdt. 2692) The registration provision, which would add a new Section 415 to the FD&C Act, is more clear regarding the scope of its applicability than are the provisions discussed above. This provision would apply to "any facility engaged in manufacturing, processing, packing, or holding food for human consumption." Despite the inclusion of qualifying language indicating that this provision applies to food for human consumption, we believe that any potential for misinterpretation could be avoided by the inclusion of language in the conference report clarifying the committee's intention that FDA not construe this provision to encompass food packaging materials that have not yet become associated with food. IV. Administrative Detention (Section 302 of H.R. 3448; Section 531 of S. Amdt. 2692) Section 302 of H.R. 3448 would expand Section 304 of the FD&C Act to provide FDA with authority to order short-term (20-30 days) detention of "articles of food" where there is "credible evidence or information indicating that such article presents a threat of serious adverse health consequences to humans or animals." We are not aware of any instance in which food packaging materials have been the vehicle for this level of public health threat. To the extent Congress finds that this expansion of FDA's authority is needed to address real emergency situations, however, SPI does not object to "articles of food" being construed more broadly for this particular purpose. * * * In conclusion, we appreciate the conference committee's consideration of the concerns discussed above regarding the potential impact H.R. 3448 could have on the food packaging materials industry. If you have any further questions regarding these comments, or would like additional information, please do not hesitate to contact us. Cordially yours, Ralph A. Simmons Maureen A. Healey cc: The Honorable John D. Dingell More
Public Policy: Environment
. Worker Safety . Transportation
. Codes and Standards . Food,
Drug,and Cosmetic Packaging . International
Trade
. Other Issues
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 © Copyright 2001 The Society of the Plastics Industry.
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