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 February 24th 2003
(202) 434-4120 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen: In this letter we report on the two draft regulations proposed by the Food and Drug Administration (FDA), pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, that will require registration of facilities and notice of imports with respect to finished food packaging materials. We also report on the latest study assessing the health risk of acrylamide in food, and summarize the U.S. Codex Office draft position on the Codex Alimentarius Evaluation Report, which recommends that Codex become more involved in packaging matters. Further, we discuss the latest developments with irradiation, including a joint venture between the U.S. Department of Agriculture (USDA) and several Minnesota school districts to educate people about irradiated beef, and the European Parliament's refusal to extend the list of foods that may be irradiated. We also provide an update on the development of the European Food Safety Agency, and report on other matters of interest in Europe. We conclude with a discussion of Australia's moves to limit the use of and increase the recycling rates of high density polyethylene bags. Table of Contents
1. Finished Food Packaging Materials Subject to FDA Proposed Bioterrorism Regulations Requiring Facilities Registration and Import Notification Draft regulations published by FDA in the February 3, 2003 Federal Register will require manufacturers of finished food packaging materials to register their facilities with the Agency by December 12, 2003, and require companies importing these items into the U.S. to provide FDA with prior notice of each shipment. Copies of the draft regulations can be found on the Agency's website at http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-npr0001.pdf (registration) and http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0278-npr0001.pdf (import notification). By way of background, the regulations are being proposed to implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The registration provisions are designed to assist FDA in determining the location and cause of a threatened or actual terrorist attack on the U.S. food supply, and to permit the Agency to quickly notify facilities that may be affected. The import notification provisions are intended to allow the Agency to target inspections more effectively, and to help ensure the safety of imported food products before they enter U.S. markets. Registration of Facilities Extends to Packaging The proposed registration regulations 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." Domestic facilities are required to register whether or not their products enter interstate commerce. Any foreign facility that engages in the same activities also is required to register unless food from that facility undergoes further processing or packaging - more than minimal in nature - before export to the United States. Covered facilities include storage locations, such as warehouses, in addition to manufacturing facilities. Food packaging suppliers are brought within the reach of the regulations by virtue of the regulation's definition of "food," which includes "substances that migrate into food from food packaging and other articles that contact food." According to the regulations, '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 information sought by the Agency includes "the name and address of each facility at which, and trade names under which, the registrant conducts business, and the categories of food the facility handles." Foreign facilities also must include the name of a U.S. agent. Import Notification Must Be Submitted The Bioterrorism Act also requires that FDA receive prior notice of foods imported or offered for import into the United States, beginning December 12, 2003. Under the proposed regulation, notice must be made by a purchaser or importer by noon on the calendar day before the day that the food arrives at the border crossing or at the port of entry. Prior notice may not be submitted more than five days before arrival at a U.S. port. As with the registration requirements, packaging materials suppliers are brought within the reach of the import notification rules by virtue of the definition of "food" in the regulations. Examples listed in the proposed rule include "substances that migrate into food from food packaging and other articles that contact food." FDA will seek a variety of information in the prior notice, including the identity of the submitter, manufacturer, grower, shipper, importer, owner, consignee, and carrier; U.S. Customs information; information about the food itself, including an FDA product code, the common name, market name, trade name, brand name, and quantities within packages and containers; the originating country and the country from which the food was shipped; and anticipated arrival information. Under the rule, food that is imported without prior notice shall be held at the port of entry or in a secure facility. Clarification Needed The application of the import notification regulation to packaging materials suppliers is particularly surprising, given the legislative history of the Bioterrorism Act. As you may recall, on behalf of the Committee, we sought clarification from Congress that packaging materials were not intended to be subject to either the registration or import notification provisions of the legislation. As a result of these efforts, 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. This language, however, addressed only import notification, and, even on that point, was less than perfectly clear. Therefore, further clarification was requested. In response, 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 disregarded express congressional intent by requiring advance notice of importation of food packaging materials not yet containing food. Obviously, we would have preferred the same type of clarification for the provision on registration of facilities. As you may recall, however, the language of the Bioterrorism Act's facilities registration provision differs from the import notification provision, applying only to certain facilities that "manufacture, process, pack or hold food for consumption in the United States" [emphasis added], rather than more broadly to "articles of food." We believe that Congress did not clarify its intent with respect to this provision in the belief that 'food for consumption' could not be misinterpreted as extending to packaging materials. Unfortunately, neither that distinction - nor very real concerns about the logistics of registering all facilities that manufacture or distribute food packaging materials - was sufficient to deter FDA from proposing registration of such facilities. During a February 12, 2003 meeting at the National Food Processors Association (NFPA), FDA officials indicated that the intent of both proposals is that the rules are to cover only finished packaging that will be in direct physical contact with food. An example used by FDA was that the regulations would apply to liners for cereal boxes, but not the boxes. In specific response to a question, FDA indicated that the regulations would not cover polymers, additives, or monomers, but only the finished food packaging made from such components. Clearly, the regulations would need to be clarified on this point. Reaction from the food industry is that the proposals will impose significant burdens on companies, and could disrupt the flow of imported goods. Some members of industry also feel that FDA is requiring far more detail from food importers in the prior notice of import proposal than mandated by the Act. The requirements will be especially onerous for those companies heavily engaged in cross-border traffic of food via land transportation. FDA is requesting comments on the paperwork burden by March 5, 2003 and the substantive portions of the proposed regulations by April 4, 2003. SPI intends to submit comments on both the paperwork burden and other portions of the proposals, particularly opposing facility registration or import notification with respect to food-contact materials as contrary to Congressional intent, providing no significant protection against terrorism, and imposing burdens on industry that are disproportionate to any minimal reduction in risk. We would be interested in hearing your reactions to the draft regulations. You also may submit comments directly to the Office of Management and Budget and/or FDA. Comments on the paperwork burden can be sent directly to the Office of Information and Regulatory Affairs at the Office of Management and Budget, New Executive Office Bldg., 725 17th St., NW, rm. 10235, Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA. Comments on the substantive portions of the proposals can be submitted via mail to FDA at the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD 20852, or electronically at http://www.fda.gov/dockets/ecomments. 2. Study Indicates Acrylamide Does Not Raise Risk of Certain Cancers High levels of acrylamide in starchy fried and baked foods do not seem to raise the risk of cancers of the large bowel, bladder, and kidney, according to a new study by researchers at the Karolinska in Sweden and Harvard University (88 British Journal of Cancer 84 (2003)). The new study was carried out in Sweden. It compared the diets of 987 patients with cancers of the large bowel (591 patients), bladder (263), and kidney (133) with those of 538 healthy people, to try to establish a link between the amount of food eaten that is high in acrylamide and the risk of the disease. Other Swedish scientists have warned that it is too soon to conclude that acrylamide is harmless, as the new study was based on a small test population 3. U.S. Codex Office Releases Draft Position on the Codex Alimentarius Evaluation Report On February 5th, the U.S. Codex Office released its draft position on the Codex "Report of the Evaluation of the Codex Alimentarius and Other FAO and WHO Food Standards Work." You may recall that one recommendation in the Report, posted on the Codex Alimentarius website on December 6, 2002, suggested that Codex should inaugurate some unspecified "new work" on packaging materials. Following release of the report, we submitted comments on behalf of the Committee to the U.S. Codex Office opposing the Report's recommendations for "new work" on packaging. The U.S. Codex Office has now released its draft recommendations on the Codex Report, and has declared that any new work Codex undertakes on packaging should be confined to health related packaging, "although this work would be problematic at best." Although the phrase "health related packaging" is not entirely clear, our contacts in the U.S. Codex Office indicate that the intent is to support SPI's position that Codex should not undertake new initiatives on packaging unless there is a specific serious health issue. The draft U.S. position requests more information as to what sort of packaging work Codex has in mind, and they suggest that any work related to packaging may conflict with the Codex resolution not to begin new work in non-health related areas. 4. USDA, Minnesota School Districts Team Up to Educate People about Irradiated Beef USDA is funding a project with the help of Minnesota's Department of Children, Families, and Learning (DCFL) in three Minnesota school districts to educate people about irradiated ground beef. No irradiated beef will be served in Minnesota schools yet, but the program may help the districts decide whether irradiated burgers belong in their schools' cafeterias. Minnesota approached USDA about sponsoring the program; Minnesota's beef council and health department promote irradiation, and Minnesota supermarkets and restaurants were among the first in the country to sell irradiated ground beef. A survey regarding knowledge and awareness of food safety and irradiation has already been distributed in the districts, and educational materials prepared by DCFL and USDA will be distributed next. At the end of the program, an analysis of how the activities affected people's awareness will be completed. This project is related to last year's Farm Bill, which directed USDA to allow the use of all government approved food safety technologies in connection with USDA's commodity purchase programs (which includes the school lunch program). 5. European Parliament Declines to Extend List of Foods that May Be Irradiated The European Parliament decided that scientific evidence of safety was insufficient to approve a proposed extension of the list of foods that may be irradiated in the EU. Spices, dried herbs and seasonings will continue to be the only items approved for irradiation in the EU until the Parliament is convinced that it is safe and efficacious to add additional foods. The European Commission supports working with the World Health Organization to research the safety of irradiated foods and investigate the risks of occupational exposure to such irradiation. The European Parliament was criticized by the Commission for asking member states to implement annual random sampling to prevent the marketing of illegally irradiated foods, especially from the U.S. and Brazil. The Commission noted that its Scientific Committee on Food has affirmed the safety of irradiated foods. The Commission plans to hear the reaction of the Council of Ministers before it makes a formal legislative proposal regarding irradiation of additional foods. Until new rules are enacted, Belgium, France, Italy, the Netherlands, and the UK may continue to irradiate dried fruits, cereals, chicken, and egg whites. 6. EFSA Seeks Funding, Members for Scientific Panel The European Food Safety Authority (EFSA) continues to develop slowly due to lack of funds. EFSA still resides at a temporary location in Brussels, as the Danish Presidency has not yet considered a permanent location for the newly formed safety body. EFSA's management board is considering how to free approximately eight million dollars held in reserve by the European Parliamentary budget committee pending a decision regarding EFSA's permanent location. In the meantime, staff recruitment and scientific panel and committee formation have slowed. The board called for expressions of interest in membership of EFSA's panels and committees, and EFSA Executive Director Geoffrey Podger plans to recommend 21 candidates by the end of April. If this occurs as planned, EFSA's risk assessment program may begin soon thereafter. 7. EU Seeks to Establish Safer Recycling Methods for Food Packaging A European Union (EU)-funded project to establish safer recycling methods for food packaging materials such as polyethylene terephthalate (PET) resins is being undertaken at the Fraunhofer Institute for Process Engineering and Packaging in Germany. European legal requirements for materials reuse are not clearly defined, according to the researchers, because of the lack of knowledge on additives and contaminants migration from the recycled materials into food. Such migration is prohibited by current EU Directives. This project may document the nature and extent of contamination in PET recovered from the food packaging market and generate a knowledge base on migration from reused paper and board packaging materials into foods. The scientists also will investigate the use of functional barriers between the recycled material and the food. The results of the studies, including the total and specific migration into the foods or food simulants, may be published soon. 8. UK Survey Concludes Oils and Waxes in Food Packaging Pose No Health Risk A UK Food Safety Authority (FSA) survey has concluded that human health is unlikely to be affected by the transfer of oils and waxes from food packaging into food. The amounts of mineral hydrocarbons from oils and waxes that would be consumed via food have been found to be within safety limits defined by the EU's Scientific Committee for Food, and the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives. The survey tested retail samples of packaging, and mineral hydrocarbons were found in 42 out of 64 samples of materials or articles in contact with food. Levels varied depending on the type of packaging. 9. Australia Seeks to Limit Use, Increase Recycling of HDPE Bags Australia must halve its use and increase its recycling of high density polyethylene (HDPE) bags by 2004 or a levy will be imposed, says Australia's federal Minister for the Environment and Heritage, David Kemp, in response to recommendations from the National Plastic Bags Working Group. The working group was created in the fall to develop measures to reduce the estimated six billion plastic bags used annually in Australia. Mr. Kemp is aiming for a 90 percent participation rate by retail chains and a 25 percent participation rate by small retailers in a voluntary National Code of Practice for the Management of Plastic Retail Carry Bags. The proposals are supported by the Australian industry association Plastics and Chemicals Industries Association. Biodegradable plastic bags may not be a solution to the problem, according to a government funded report prepared by Nolan-ITU Pty. The report asserts potential problems with biodegradable plastic, including oxygen depletion caused by starch breakdown, water pollution resulting from degradation, and a possible increase in littering. * * * As always, if you have any questions on the above, or if we can be of assistance in any other way, please do not hesitate to contact me, Jerry Heckman or Deborah Ziffer. Cordially yours, Ralph A. Simmons Back to TopMore About SPI: Vision and Mission . Membership . Business Units . Regional Offices . News and Publications . 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 © Copyright 2005 The Society of the Plastics Industry.
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