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 April 17, 2003
(202) 434-4120 The Society of the Plastics Industry, Inc. Food, Drug, and Cosmetic Packaging Materials Committee Dear Ladies and Gentlemen:
Table of Contents
1. Committee Submits Comments to OMB and FDA on FDA's Proposed Rules to Require Prior Notice of All Food Imports and Registration of Food Facilities On behalf of the Committee, we submitted comments to OMB and FDA regarding FDA's proposed rules to require prior notice of all food imports and registration of food facilities. As we discussed in our last letter to the Committee, these proposals were drafted to implement provisions in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the "Bioterrorism Act"). In both sets of comments, we confirmed the support of SPI and its members for meaningful protection of the American food supply against terrorism. On the other hand, we voiced SPI's opposition to extending the requirements to food packaging materials not yet containing food on the basis that it is in contravention of Congressional intent and will unduly burden industry while providing no significant protection against terrorism. With regard to the prior notice of import provision, we pointed out explicit legislative history obtained as a result of efforts by SPI. As we reported to you previously, in response to our request for clarification from Congress that packaging materials were not intended to be subject to this provision, the Joint Explanatory Statement of the Committee of Conference for the bill had 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, and FDA clearly disregarded this intent by proposing to require advance notice of importation of these materials. We hope that FDA will revise its regulations to comport with Congressional intent. In the comments regarding the registration provision, we pointed out that the terminology used in Section 305 of the Bioterrorism Act (setting forth the provisions for registration of food facilities) is significantly different from that in Section 307 (setting forth the provisions for prior notice of import). Specifically, Section 305 states that facilities that "manufacture, process, pack or hold food for consumption in the United States" will be required to register (emphasis added). This is different language from the term "article of food" in the prior notice of import provision. Based on our discussions with Congressional staff and others involved in developing the Bioterrorism Act, we are quite confident that Congress intended the phrase "food for consumption" (emphasis added) to refer to edible food only, not "food" with 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, we are confident that this was based on the assumption that nobody would misconstrue the meaning of "food for consumption" as applying to anything but edible food. Also, since Congress has 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. We further cited as another indication that Congress did not have food-contact articles in mind as triggering facilities registration under the Bioterrorism Act 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 proposed to include the categories from § 170.3 as a mandatory field on the registration form. However, § 170.3 does not include categories for food-contact materials. We also pointed out that it was unclear at this point which food-contact materials the Agency intends to be included in the provisions. While the terminology used in the proposals could be interpreted to mean that any material used in the production of food packaging is subject to the requirements, 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." 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. Subsequent to the issuance of the draft regulations, FDA officials spoke at a meeting at the National Food Processors Association and attempted to clarify further which packaging materials would be subject to the requirements. This attempt at clarification only led to further confusion, however. 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. 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 posed by us at the meeting, 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 in FDA's proposals does not limit the coverage of the regulation as FDA apparently intends. Regardless of what food-contact materials FDA is recommending be included in the provisions, we stressed that, in light of clear Congressional intent to exclude food-contact materials not yet containing food from the provisions, the Agency should insert in the regulations language specifically exempting all "empty" packaging materials from the requirements. Included in the comments was draft language that the Agency could use to accomplish this effect. We also included draft language that FDA could use to limit the scope of food packaging materials covered under the rules if it chooses to go forward with including only "finished" food-contact materials, although we are confident that would not be in accordance with Congressional intent. Finally, we pointed out the significant burden that the proposals would place on the food packaging industry, regardless of whether or not the requirements would apply only to finished food packaging. 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. The burdens that would be placed on the food packaging industry by the proposed regulations would be disproportionate to any minimal reduction in risk and would provide no significant protection against terrorism. With regard to the registration requirement in particular, it would apply not just to the facilities that manufacture the products, but also to the warehouses where they are stored. Large companies, particularly multinationals, would have to spend an inordinate amount of time simply identifying the facilities that would need to be registered and putting in place mechanisms for meeting their obligations, including the updates FDA proposes to require. Further, including in the registration requirement facilities that manufacture or hold food packaging material would require registration of many facilities that are principally non-food industrial suppliers but also have a small business in supplying materials being used in food packaging. Also included would be independently owned warehouses that store small amounts of materials used in food packaging. Some owners of these independent warehouses may not even be aware that they are storing food-contact materials that would be subject to the provision. Materials used principally in non-food applications also often have food-contact uses, which may not be known to every facility that handles the materials. With regard to the importation of food-contact materials, many 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. Finally, we pointed out that 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. Further, requiring registration of food-contact materials and prior notice of importation of these products would divert FDA attention and resources from activities directed toward more immediate food security risks. SPI's comments, as well as comments submitted from other interested parties, can be viewed on FDA's website at http://www.fda.gov/ohrms/dockets/dockets/dockets.htm. 2. GAO Reports Call for Increased Oversight of Security Measures at Food-Processing and Chemical Facilities Two reports issued by GAO on March 18th recommend increased government oversight of security measures being taken at food-processing facilities and chemical plants to prevent incidences of terrorism. These reports can be found on GAO's website at www.gao.gov. The first report specifically examined FDA and the U.S. Department of Agriculture's (USDA) oversight of security measures at food-processing facilities and found that neither agency has the authority to regulate all aspects of security at these facilities. Although both FDA and USDA have issued security guidelines to help food processors identify measures to prevent or mitigate the risk of deliberate contamination, neither agency enforces, monitors, or documents their implementation, since guidelines are voluntary. FDA and USDA have asked their inspectors to discuss security with managers at food-processing facilities, but the agencies have stressed that inspectors should not enforce the implementation of security measures or document any observations because of the possible release of this information under the Freedom of Information Act (FOIA) and the potential for misuse of this information. Further, since FDA and USDA do not monitor and document food processors' implementation of security guidelines, the extent of the industry's adoption of security measures is unknown. As a result of its findings, GAO recommends that the Departments of Health and Human Services (HHS) and Agriculture study their agencies' existing statutes to identify what additional authorities they may need relating to security measures at food-processing facilities to reduce the risk of deliberate contamination of the food supply. On the basis of these studies' results, GAO proposes that the agencies should seek additional authority from Congress, as needed. GAO also recommends that the agencies provide training for all food inspectors to enhance their awareness and ability to discuss security measures with plant personnel. The second GAO report examined the security of industrial facilities that use or store hazardous chemicals in quantities that could potentially put large numbers of Americans at risk of serious injury or death in the event of a terrorist-caused chemical release. GAO found that, despite the extensive voluntary initiatives taken by the chemical industry to address security at its facilities, the extent of security preparedness at U.S. chemical facilities is unknown. GAO recommends that the Secretary of Homeland Security and the Administrator of the Environmental Protection Agency (EPA) jointly develop a comprehensive national chemical security strategy that is practical and cost effective, and aimed at assessing vulnerabilities and enhancing security preparedness. In the wake of these reports, members of Congress are examining the need for legislation that would provide government agencies with additional authority to oversee efforts by companies to implement security measures at food-processing and chemical facilities. Senators Richard Durbin (D-IL) and Tom Harkin (D-IA) have asked HHS to report to Congress within 180 days from March 13th whether FDA needs additional powers or resources to address security risks at food processing facilities. Additionally, Reps. Frank Pallone (D-NJ) and John Dingell (D-MI) have voiced their intention to offer legislation that would address the key recommendations in the chemical security report. 3. FDA Releases Bioterrorism Guidance Documents for Food, Cosmetics Industries FDA recently released four guidance documents for the food and cosmetic industries that are aimed at assisting companies in implementing security measures intended to help protect against terrorist attacks. Two of the guidance documents are finalized versions discussing measures that operators of food establishments (for example, firms that produce, process, store, and distribute food) and operators of food importing establishments can take to improve the security of their operations. Both documents can be found on FDA's website: http://www.cfsan.fda.gov/~dms/secguid7.html ("Importers and Filers: Food Security Preventive Measures Guidance") and http://www.cfsan.fda.gov/~dms/secguid6.html ("Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance"). The other two guidance documents are in draft form: one addresses preventive security measures for retail food stores and food service establishments, and the other addresses preventive security measures for cosmetics processors and transporters. 4. Panel Recommends that FDA Give Consumers More Information on Acrylamide FDA's Food Advisory Committee has weighed in on FDA's advice to consumers on acrylamide. Currently, the Agency advises consumers to eat a balanced diet, but does not provide any more targeted advice on the substance. FDA is hesitant to change its current consumer message on acrylamide due to the lack of data on the health risk to humans. While the panel generally agreed that there still is not enough data on acrylamide to warrant FDA changing its advice, the panel also felt that consumers could be provided with more information on its possible risks. To provide more information to consumers, the panel suggested that FDA consider posting on its website the latest data on acrylamide's risk and what the data mean. One panelist further recommended that any information on acrylamide provided to consumers by FDA should have an "interpretive document" that points out the current data's strengths and weaknesses, as it would be better to have FDA interpret the data than leave that task to the media or the public. In other acrylamide news, a recent FDA survey shows that eight foods account for the bulk of acrylamide in the U.S. diet. Four of the main foods include potato chips, french fries, breads and cereals. 5. New European Study Looks at Health Risks from Chemical Byproducts Found in Irradiated Foods; Public Citizen Files New Comments with FDA Citing This Report A new study funded by the European Union examines the toxicity of chemicals called 2-alkylcyclobutanones (or 2-ACBs) that are found only in irradiated foods. 2-ACBs are formed when food containing fat, such as beef, chicken and eggs, is irradiated. Specifically, the results of the study indicate that 2-ACBs accumulate in the adipose tissue of rats fed the compounds and promote tumor development in rat colons. The study also confirms research published in 1998 and 2001 indicating that concentrations of 2-ACBs may damage DNA. The authors of the report caution that, while the compounds show toxic effects in lab animals, they did not test whether they are toxic in humans. A dose/response relationship for 2-ACBs also has not been established. The results of the study were a factor in the recent decision by the European Parliament to reject a proposal to expand the types of food that could be irradiated. Subsequent to the release of the report, the Scientific Committee on Food reversed its position on the safety of irradiated foods, stating that it could not endorse moves to allow the irradiation of all foods above the current maximum irradiation dose limit of 10kGy because of insufficient research assessing the safety of eating foods irradiated at doses above this level. As recently as July of last year, the SCF had stated that there was inadequate evidence of hazard from eating irradiated food and that such foods could be considered safe. On the heels of this report, Public Citizen and the Center for Food Safety filed joint comments opposing pending petitions to expand the use of irradiation and urging FDA to reconsider its past approval of irradiated foods. The comments also called on the Agency to conduct a comprehensive risk assessment. The National Food Processors Association (NFPA), which is the sponsor of a petition pending at FDA that would allow irradiation of ready-to-eat foods, filed comments with the Agency rebutting the consumer groups' position. NFPA pointed out weaknesses in the EU report, such as the difficulty in extrapolating results from in vitro and animal studies to humans. NFPA's comments also cited the authors' conclusion that 2-ACBs showed toxic effects in lab animals but have not been shown to be toxic to humans. 6. Study Indicates BPA Harms Development of Mouse Eggs A research team at the Case Western Reserve University in Cleveland found unusual genetic defects in the eggs of laboratory mice and traced the defect to their hard plastic cages, which were apparently emitting small amounts of bisphenol A (BPA). As we have discussed many times, BPA has been studied extensively in recent years to assess its health implications. The team responsible for the most recently published study claims that 20 parts per billion (ppb) of BPA in drinking water damaged eight percent of fertilized eggs in female mice by stopping chromosomes from dividing up equally before the cells divide. The disruption of cell division can result in an abnormal number of chromosomes in the eggs, a condition known as aneuploidy, which is the leading cause of mental retardation and birth defects in humans. It is not known if BPA has a similar effect on human embryos. Last year, the EU cut back its upper limit for daily intake of BPA, but FDA does not feel that there is sufficient evidence to change U.S. intake levels. The House of Representatives approved on March 12th legislation that would require drugmakers to include bar codes on drug packages. The bill, entitled the "Patient Safety and Quality Improvement Act" (H.R. 663), would authorize FDA to implement a rule it proposed that would require drug and biological product labels to have bar codes containing the National Drug Code (NDC) number. NDCs are universal product identifiers for human drugs. The legislation is now being considered by the Senate Committee on Health, Education, Labor, and Pensions. The proposal aims to reduce medication errors by allowing health care professionals to use bar code scanning equipment to verify that the right drug is being given to the right patient at the right time. The proposed rule also would require the use of machine-readable information on blood and blood component container labels to help reduce blood type errors. These proposals could cost drug companies $1.5 billion over 10 years, according to government estimates. 8. SCF Releases Opinion on 21st Additional List of Substances in Plastic Food Packaging The European Commission's SCF released on March 5th its opinion on the 21st additional list of monomers and additives for food contact materials. Bay way of background, in May 1997, the SCF's evaluations of monomers and additives used in the manufacture of food-contact plastics were compiled into the 42nd Series of Reports of the SCF. Since that date, the committee has evaluated or reevaluated a number of substances, and has published its results in a series of 21 opinions. Those opinions are available on the committee's website at europa.eu.int/comm/food/fs/sc/scf/outcome_en.html.SCF's opinions classify the listed monomers and additives into safety categories, identified as "SCF Lists," ranging from 0 through 9, and "W" ("waiting list"). Lists 0 through 4 generally include substances that have been reviewed by the SCF and determined to be safe for use in food-contact applications. List 5 denotes substances that the SCF has indicated "should not be used" in contact with food, and list 6 applies to substances for which some toxicological concerns have been raised. List 7 applies to substances for which some toxicological data exist, but for which an acceptable daily intake (ADI) or tolerable daily intake (TDI) could not be established. For substances classified in list 8, inadequate data are available for the SCF to complete an evaluation. Substances in list 9 also could not be evaluated due to lack of specifications or lack of an adequate description. Substances that are the subject of an SCF opinion eventually are added to the Commission of the European Communities (CEC) Synoptic Document "Draft of Provisional List of Monomers and Additives Used in the Manufacture of Plastics and Coatings Intended to Come into Contact with Foodstuffs" (commonly known as the "Synoptic Document") for possible inclusion in a subsequent amendment to Commission Directive 2002/72/EC, known as the "Plastics Directive." In the Opinion of the SCF on the 21st additional list of monomers and additives, the SCF provided its evaluation of the following substances (followed here by their reference number, chemical abstract service number (CAS No.), and SCF List designation):
To download a copy of the SCF's opinion on the 21st additional list, visit: www.europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf. 9. European Council Adopts Common Position on Draft Amendment to Packaging and Packaging Waste Directive As we reported to you last September, the European Council has been working on a draft amendment to Directive 94/62/EC on packaging and packaging waste that seeks, among other things, to change the recycling and recovery rates for certain materials. On March 6th, the Council adopted a common position on the draft amendment. Provisions included in the common position are:
The European Commission accepted the common position, and the draft will now go back to the European Parliament for a second reading. The European Parliament's rapporteur has proposed that a plenary vote be taken in July. 10. German Plastics Recommendations Now Available in English on the Internet The German Plastics Recommendations of the Federal Institute for Risk Assessment (BfR) (formerly known as the "BgVV Recommendations") are now available in English on the internet at http://www.bgvv.de/cms/detail.php?template=internet_en_index_js. As you may know, one way for a manufacturer to assure that food-contact products meet the German general safety requirements is to consider guidance contained in the BfR Recommendations. The recommendations define specific positive lists of starting substances and additives that are permitted for use in individual food packaging applications. Although they are not legally binding, the BfR Recommendations are widely respected in Germany, and German manufacturers often insist that materials meet the Recommendations. 11. German Recycling Fees for Cans May Increase Use of PET Bottles A recent German law that introduced substantial recycling fees for aluminum cans may encourage the use of polyethylene terephthalate (PET) bottles as an alternative for holding beverages. In a move that many see as an indication of a growing trend, a major German supermarket chain, Aldi, recently confirmed that, because of the deposit law, it plans to discontinue sales of beer in cans and offer it in PET bottles instead. This will allow the chain to save costs related to the return of cans and allow time for the development of a system for returnable packaging. PET with enhanced barrier properties may be the key to use of PET bottles among brewers across Europe. Beer has a high level of carbon dioxide, and leakage due to porous packaging can lead to flatness. Also, oxygen passing through the bottle wall into the beer can lead to taste distortion. PET is more porous than glass or aluminum, so beer in PET bottles has a limited shelf life unless barrier technology is used. Advanced barrier technologies have been shown to prolong the shelf life of beer to more than six months. Normal barrier technology impedes oxygen entry, but more advanced systems can trap the oxygen and bind it to the bottle wall. 12. Japan Implements New Requirements for Recycling and Labeling of Paper and Plastic Packaging On April 1, 2003, the Government of Japan fully implemented its new Package Recycling Law. The law requires manufacturers to pay all costs associated with collecting, sorting, transporting and recycling paper and plastic packaging. Paper and plastic packaging and containers also will need to be labeled for appropriate recycling. Importers will bear primary responsibility for recycling costs and labeling of imported products, but it is possible that Japanese importers will begin to take recycling costs into account when choosing the goods they import. Additionally, importers may ask U.S. manufacturers and exporters to assist in supplying the required labeling. 13. Taiwan Limits Use of Plastic Bags and Disposable Tableware Taiwan's Environmental Protection Agency (EPA) gave warnings to eight violators of the new environmental policy that limits the use of plastic bags and disposable tableware. On January 1, 2003, the ban on free plastic bags and utensils expanded from government run stores to almost every type of retailer, affecting more than fifty thousand stores. The eight violators were found among 831 retail locations inspected in mid-February. EPA Administrator Hau Lung-bin feels that this preliminary inspection shows satisfactory compliance with the measures. In the future, violators will face fines. The public is encouraged to use EPA's toll-free hotline to report violations or ask questions about the new policy. * * * 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 . Calendar of Events . Terms and Conditions of Use |
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 © Copyright 2005 The Society of the Plastics Industry.
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