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 April 4, 2003 Dockets Management Branch (HFA-305) Re: SPI Comments on Proposed Regulations on Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 [Docket No. 02N-0278] Dear Madam or Sir: The Society of the Plastics Industry, Inc., (SPI)1 by its attorneys and through its Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC), hereby respectfully submits these comments with regard to the notice entitled "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002," which was published in the Federal Register on February 3, 2003 (68 Fed. Reg. 5428). This notice requested public comment on the implementation of the provision requiring that companies importing food to the U.S. provide FDA with prior notice of each shipment. This provision is contained in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act"). Section 307, Pub. L. 107-188 amending Federal Food, Drug, and Cosmetic Act (FFDCA) (codified at 21 U.S.C. 381(m) et seq. (2002)). SPI and its members fully support Congress and the Food and Drug Administration in implementing meaningful steps to protect the U.S. food supply from terrorist acts. The plastics industry stands ready to participate in this important effort. However, as explained more fully below, we respectfully submit that FDA's proposal to extend the prior notice of import requirement to food packaging and other food-contact articles that do not yet contain food is in direct contravention of Congressional intent and will unduly burden industry while providing no significant protection against terrorism. Including Food Packaging Materials in the Prior Notice of Import Provision Is in Contravention of Congressional Intent as Stated in the Legislative History of the Statute By way of background, FDA seeks to bring suppliers of food-contact materials within the reach of the proposed regulation by referring to the definition of "food" found in Section 201(f) of the FFDCA, 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). Historically, FDA has relied on the FFDCA's definition of "food" in conjunction with its definition of "food additive"2 to provide a basis for the Agency to assert regulatory authority over any food-contact materials that are also food additives. In this case, the proposed regulation includes a list of examples of products that FDA considers to be covered by the definition of "food," and the list identifies "substances that migrate into food from food packaging and other articles that contact food" as "food" for purposes of the regulation. SPI was concerned that the prior notice of import provision in the Bioterrorism Act might be misinterpreted as including food-contact materials due to the use of the term "article of food" in the Bioterrorism Act and the definition of "food" in the FFDCA. Therefore, we sought clarification from Congress that packaging materials were not intended to be subject to this provision of the legislation. 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. In addition, the bill manager in the House, Rep. John Shimkus (R-Ill.), entered into the Congressional Record on May 24, 2002 an extension of remarks stating: 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, FDA has not followed expressed congressional intent by proposing to require advance notice of importation of food packaging materials not yet containing food. In light of the clear intent of Congress to exclude food packaging materials from the prior notice of import provision in the legislation, we recommend that FDA insert in the regulation language specifically excluding food-contact materials not yet containing food. To accomplish this, we propose that the phrase "including substances that migrate into food from food packaging and other articles that contact food" be removed from the discussion in Section 1.277(c)(3) of the proposed rule, and that the following language be inserted into this section: "for purposes of this provision, "food" does not include food-contact materials not yet containing food at the time of importation." FDA Apparently Intends Import Notification to Apply Only to Some Packaging Materials, But the Proposed Regulation Does Not Implement that Intent FDA has indicated that only certain packaging materials are intended to be subject to the import notification requirement. In this regard, 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." The terms "immediate food packaging or components of immediate food packaging," however, 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.3 Also, FDA has not addressed the situation in which a packaging material, such as paper or film, may have a coating: would the paper or film that is intended to have a coating be subject to the provision, or just the coating materials? During a February 12, 2003 meeting at the National Food Processors Association, FDA officials attempted to clarify further which packaging would be subject to the prior notice of import requirement, and specifically indicated that the intent of the proposal is for the rule to cover only finished packaging that will be in direct physical contact with food. An example used by FDA was that the regulation would apply to liners for cereal boxes, but not the boxes. In response to a question, FDA indicated that the regulations would not cover polymers, additives, or monomers, but only the "immediate" food packaging made from such components. We assume from FDA's statement that this regulation also was not really intended to apply to the many other components of food packaging, some of which are identified above. The current language in FDA's proposal, however, extending to "components of immediate food packaging," does not limit the coverage of the regulation as FDA apparently intends. It is also unclear whether FDA intends to include only the final, completely formed packaging, or also the film or sheet or other bulk materials from which the final packaging is formed. As discussed above, requiring import notification for any packaging that is not yet in contact with food is contrary to Congressional intent, and the proposed regulation should be revised to exclude empty food packaging. However, the proposal requires amendment even to implement FDA's expressed intent to cover only "immediate" packaging. It is SPI's position that the definition of "food" for purposes of the regulation would need to exclude food-contact materials other than finished food packaging intended for direct contact with food.4 The Burden on the Packaging Materials Industry Is Disproportionate to Any Reduction in Risk Including food packaging materials in the regulation also will impose burdens on the industry that are disproportionate to any minimal reduction in risk and will provide no significant protection against terrorism. The uncertainty regarding the packaging materials actually covered by the proposed regulation makes it impossible at this point to even estimate the number of companies and shipments that might be involved. As drafted, the proposed regulation apparently extends to all components of immediate packaging that migrate to food, and would apply to an enormous number of companies and shipments. If, as FDA has indicated, the regulation is intended to cover only finished immediate packaging, this is undoubtedly a smaller part of the packaging industry, but we are not aware of information that would allow us to quantify the impact with any precision. Additional uncertainty over the magnitude of the burden derives from the fact that FDA's proposal is not even limited by its terms to packaging, much less to finished packaging. The Agency's definition of "food" would extend to "substances that migrate into food from food packaging and other articles that contact food." (Emphasis added.) We assume that FDA really means to require notice of importation of the articles from which migration occurs, not the migrating substances themselves. Putting aside that ambiguity, however, still leaves the apparent requirement for notification concerning imports of food-contact articles other than packaging, such as food processing equipment and glassware, dishware, cutlery, kitchen appliances (and other "houseware" items). If the regulation continues to read this broadly, it will impose a significant burden on a large number of companies. In addition, materials with food-contact applications often have non-food uses as well. 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, and, therefore, may not realize that they even 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. Furthermore, prior notice to FDA of the importation of food packaging and other food-contact articles would have limited usefulness in satisfying the purpose of the Bioterrorism Act, which is to "expand FDA's powers to prevent and respond effectively to terrorist threats against the food supply." While SPI and its members certainly support reasonable efforts to minimize the risk of terrorist acts, FDA does not explain how prior notice of the import of food-contact materials 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 regulation, FDA discusses five outbreaks of foodborne illness, but there is no mention of food-contact materials being related to any such occurrences. It does not seem likely that terrorists would attempt to contaminate food indirectly by tampering with empty packaging. Additionally, requiring prior notice of import for food packaging materials would divert FDA attention and resources from activities directed toward more immediate food security risks. FDA's Estimate of the Burden on Industry Is Inaccurate FDA requested comment on the accuracy of its estimate of the economic burden of the proposed regulation. To arrive at this estimate, the Agency used information in its Operational and Administrative System for Import Support ("OASIS") database and determined that there are approximately 77,427 importers and consignees who receive shipments of food for human and animal consumption in the U.S. The Agency further stated that it will be these 77,427 importers or U.S. purchasers that will be primarily responsible for submitting the prior notice information. It is doubtful whether all importers of empty food packaging and other food-contact materials are included in the 77,427 figure. As OASIS is an internal FDA database that is inaccessible to the public, we were not able to verify the figure. However, since FDA specified that the 77,427 figure represents importers and consignees who receive shipments of "food for human and animal consumption," we surmise that the figure likely represents importers and consignees of edible food only and, therefore, does not include importers of food packaging materials, except to the extent that there may be some companies in both categories. As a result, FDA's estimate of the economic burden probably is low, and the Agency should clarify this point. * * * In summary, the burden on industry to provide prior notice of importation of "food" should not be extended to any food packaging (not already containing food) or other food-contact articles. FDA's proposal is contrary to the expressed intent of Congress, and will not provide protection against terrorism that would justify the burden. If FDA nevertheless continues to propose inclusion of some food-contact materials within this proposed regulation, the scope of the products to be covered must be clarified. SPI's FDCPMC appreciates this opportunity to comment on the proposed regulation. SPI and its members also reiterate their willingness to work with FDA and other government agencies to implement significant protection against terrorism. Sincerely, Ralph A. Simmons 1. Founded in 1937, The Society of the Plastics Industry, Inc. is the trade association representing the fourth-largest manufacturing industry in the United States. SPI's 1,500 members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers, and raw material suppliers. The U.S. plastics industry employs 1.5 million workers and provides $330 billion in annual shipments. The Food, Drug, and Cosmetic Packaging Materials Committee is composed of SPI members with particular interest and expertise in packaging for food and other FDA-related products. The Committee has a long history of working cooperatively with FDA on regulatory issues relating to packaging. 2. Section 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. 3. For more of an insight into the breadth of materials that possibly could be included, one can refer to the numerous food-contact substances listed in 21 C.F.R. Parts 174-178 of FDA's food additive regulations. 4. FDA would need to remove the phrase "including substances that migrate into food from food packaging and other articles that contact food" from the discussion of the definition of food in Section 1.277(c)(3) of the proposed rule. The following language should be inserted: "FDA does not intend for all packaging materials to be subject to this provision. Only "finished" food packaging intended for direct contact with food, which is in its final form and requires no further processing before food can be added, is intended to be subject to this provision. "Further processing" does not include minor alterations to the exterior of the packaging, such as the application of labels or inks." SPI is not recommending this definition because Congress did not intend import notification to apply to any empty food packaging materials. We simply point out that clarification of the proposed regulation would be needed to implement FDA's stated intent properly. 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