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 September 6, 2001
(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 try to bring some perspective to the article in a prominent Danish business magazine alleging, based on insufficient data, that there are dangerous levels of cancer-causing aromatic amines in food packaged in multilaminates in Europe. We also report on the submission by the National Center for Food Safety and Technology (NCFST) of a food-contact notification (FCN) to the Food and Drug Administration (FDA) for the use of ethylene vinyl alcohol (EVOH) to hold food during irradiation; FDA's issuance of guidance documents on electronic submissions; and the latest Congressional bill seeking uniformity in food safety warning requirements. Finally, we discuss the publication of the Sixth Amendment of the Monomers Directive and the final Directive on BADGE, BFDGE and NOGE by the European Commission, and other matters of interest to the Committee. Table of Contents
1. Danish Article Alleges Dangerous Levels of Aromatic Amines in Plastic Laminates An article published last month in a leading Danish business magazine, Børsen Nyhedsmagasin (and summarized in a subsequent Financial Times article), claims that dangerously high levels of cancer-causing aromatic amines are found in foods packaged in plastic laminates. A large variety of foods sold throughout Europe, including sliced meat, frozen foods, cheese and chocolates, are packaged in this type of material. The issue relates to polyurethane adhesives in the films, which contain isocyanates that may release aromatic amines into the food if the adhesives are not allowed to cure properly before the food is packaged. The aromatic amines are suspected of causing not only cancer, but allergic reactions as well. The Danish magazine asked the Steins Laboratory to conduct tests on samples of food packaged in the material in question. The article alleges that the results show that "eight out of ten of the tested foodstuffs contain cancer-causing glue residues . . . in quantities that exceed the recommended safe limits by as much as 30 to 40 times." However, it is widely known in industry that there is enormous difficulty in analyzing "real-life" food samples for the presence of aromatic amines. Indeed, the Steins Laboratory issued a press release on August 15th, stating that the findings in connection with the initial tests of packaging for content of aromatic amines "are not validated as yet and cannot be used to substantiate any argument at this stage." Further, based on tests conducted thus far, the laboratory "cannot prove that the packaging liberates aromatic amines" into food, and that further testing is needed. The article and the testing on which it is based have not been viewed by Danish or European Commission authorities as establishing a significant health concern requiring urgent action. The Danish Veterinary and Food Administration has indicated that the sampling and test conditions were not appropriate to determine if a real issue exists, although this agency also requested assurance from industry that migration of amines does not exceed specified limits. Both FDA and the European Union (EU) place limits on the use of isocyanate-based adhesives to avoid significant migration of aromatic amines. In Europe, scientific experts and Danish and European Commission authorities are discussing the appropriate methodology for determining migration of amines from packaging to food. We do not anticipate any further regulatory reaction pending more determinative testing. We understand, however, that the author of the Danish story, Morten W. Langer, intends to publish additional articles on this issue in the near future. In the meantime, we will continue to monitor this situation closely and keep the Committee informed. 2. NCFST Submits FCN for Use of Irradiation with EVOH In late July, the National Center for Food Safety and Technology (NCFST) submitted to FDA an FCN for the use of EVOH to hold food during irradiation. If the notification becomes effective, industry will have explicit FDA sanction for the use of EVOH at a thickness up to 7 mils in high barrier films to package food for irradiation. NCFST is a joint venture of FDA, industry, and the Illinois Institute of Technology, and is located in Chicago. A submission to obtain FDA clearance for materials to be used to hold food during irradiation must contain studies demonstrating the potential for formation and migration of radiolytic byproducts from the packaging materials to the food. It has been reported that the EVOH notification asserts that the radiolytic byproducts formed during irradiation are below 0.5 part per billion (ppb) and, therefore, no mutagenicity tests are necessary in accordance with FDA's guidelines. As we have explained in previous letters, in our view, all packaging materials intended for holding food during irradiation do not need explicit FDA clearance to have a suitable FDA status for the intended use. If a material has a suitable FDA status for use in food packaging applications, generally, we consider it suitable for use in holding food for irradiation if it can be demonstrated that no significant change in the potential migrants is caused by irradiation. Of course, testing usually is required to support such a conclusion, and appropriate FDA guidance would be helpful to companies in conducting the proper tests. As discussed in our May 10, 2001 letter, a recommended protocol for irradiation testing has been provided by FDA to certain companies (and, we understand, to NCFST) currently seeking FDA clearance of packaging materials for the irradiation of food. While there has been no published guidance from FDA in this regard, it is our understanding that the Agency plans to issue formal guidance on irradiation testing. NCFST is quoted as saying that this EVOH notification is the forerunner of a series of notifications it plans to submit to allow the use of other materials to hold food during irradiation. Those other materials include: nylon 6,6; nylon 6,66; nylon 6I, 6T; ionomer and anhydride grafted polyethylene; and others. 3. FDA Issues Guidance Documents on Electronic Submissions You may recall that, at the June meeting of the FDCPMC, FDA's Dr. Mitchell Cheeseman provided information on the Office of Food Additive Safety's (OFAS) development of a program for accepting electronic submissions. On July 31, 2001, FDA announced the availability of two draft guidances in this regard, entitled "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format - General Considerations" and "Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions." See 66 Fed. Reg. 39517 (July 31, 2001). The General Guidance provides recommendations on the following topics to help petitioners create the mandated Portable Document Format (PDF) files for OFAS review:
OFAS must be able to generate an accurate, legible, and complete paper copy of any electronically submitted petition. OFAS requests that they be notified prior to the submission of an electronic document so that they can schedule a teleconference or meeting between the petitioner and OFAS staff to discuss the proposed submission's management paradigm, content, format, and structure. At that time, OFAS will discuss issues relevant to the specific submission that may not have been addressed in the general Guidance. We talked to OFAS' Dr. JoAnn Ziyad about how the Agency intends to protect the confidential aspects of electronic submissions. She informed us that, when an electronic submission arrives at OFAS, it will be copied both to the archives and to the network server to create a read-only copy for the reviewer. The submission will not, at any time, be available online. Currently, when paper submissions are received by OFAS, they are converted into electronic documents for review; if petitions are submitted electronically, this process simply is expedited. There is no other difference between paper and electronic submissions in terms of how the documents are disseminated within the Agency. Dr. Ziyad also told us that, to ensure that OFAS is aware of the confidential nature of confidential business information in an electronic submission, the petitioner must distinguish confidential text from other text. OFAS does not make regulatory petitions available online, so persons requesting them must do so through the Freedom of Information Act (FOIA). OFAS will exclude confidential business information, as designated by the petitioner in the original paper or electronic document, when making the petition available under FOIA. In excluding confidential information from submissions being copied through FOIA, OFAS will not distinguish paper from electronic submissions in any way. The general guidance document is available on FDA's website at http://www.cfsan.fda.gov/~dms/opaeguid.html; the guidance specifically addressing electronic submissions of food additive and color additive petitions also is available on FDA's website at http://www.cfsan.fda.gov/~dms/opaegui2.html. FDA is accepting comments on the guidance until October 1, 2001. Please let us know if you have concerns about the guidance documents, or electronic submissions generally, and would like us to submit comments in this regard. 4. Proposed Federal Uniformity Legislation for Food Labeling May Have Impact on California's Proposition 65 The latest incarnation of a bill intended to promote uniformity in food safety warning requirements was introduced in the U.S. House of Representatives on July 26, 2001. The National Uniformity for Food Act of 2001 (H.R. 2649), which seeks to amend the Federal Food, Drug, and Cosmetic Act, was first introduced in Congress in 1998. As we have been reporting to you, the bill supports a long-standing food industry effort to promote uniform labeling laws. Interest in the legislation can be traced back to the late 1980s, when a variety of food and food packaging industry organizations became concerned with the labeling requirements imposed by the California Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65. Under the proposed federal legislation, any notification requirements concerning "the safety of food, or any component of package of the food" would preempt state requirements, except in special circumstances. Unaffected by the proposed legislation would be state laws regarding freshness dating, open date labeling, grade labeling, state inspection stamps, religious dietary labeling, organic or natural designation, returnable bottle labeling, unit pricing, or statements of geographic origin. In addition, states would remain free to establish their own notification requirements under an "imminent hazard authority," and may petition the federal government for permission to retain existing standards. The bill has been referred to the House Committee on Energy and Commerce, and is currently sponsored by 29 representatives. Not surprisingly, state officials and activist groups, such as the Center for Science in the Public Interest, have expressed concerns over the proposed legislation. In particular, they assert that the federal law would undermine state regulatory efforts to ensure the safety of products that, in their opinion, are not regulated by federal agencies as stringently as they would prefer (such as dietary supplements). Because the proposed federal legislation would have the effect of preempting state laws concerning labeling for both food and food packaging products, California's Proposition 65 would be directly affected if the bill were to become to law. Under Proposition 65, California publishes a list of chemicals "known to the state to cause cancer or reproductive toxicity." This list is derived from lists maintained by authoritative bodies, such as the National Toxicology Program and the International Agency for Research on Cancer. Products containing listed chemicals must bear "clear and reasonable" warnings if consumer or occupational exposures exceed a "no significant risk level" (NSRL) for carcinogens or a "no observable effect level" (NOEL) for reproductive toxicants, as established in accordance with California regulations. Violations are punishable by civil penalties of up to $2,500 "per violation," per day. Currently, California Attorney General William Lockyer is seeking recommendations for legislative and regulatory reform to resolve the problems associated with the operation of Proposition 65. Lockyer is interested in preserving the consumer protection and anti-pollution effects of the law, while addressing issues of concern regarding compliance and enforcement. For example, a provision of Proposition 65 allows private citizens (and their attorneys) to bring an action on behalf of the state if public prosecutors do not file an action 60 days after notice is given to the alleged violator and to public prosecutors. Prevailing plaintiffs may recover 25 percent of any civil penalty, in addition to attorneys' fees and costs. This aspect of the law, particularly the financial incentive, has spawned a great deal of litigious activity. Lockyer is soliciting input from environmental groups, businesses, Proposition 65 defense attorneys, and private parties engaged in enforcing the law. California's experience has not only garnered Congressional attention, as evidenced by the proposed uniformity legislation, but also has served to deter the passage of laws similar to Proposition 65 by other state legislatures. For example, laws modeled after Proposition 65 have been introduced in Massachusetts regularly since the late 1980s, but they have never been passed. Currently, there is legislation pending in that state requiring the labeling of genetically modified foods (H.R. 3252). State officials in Massachusetts already have expressed concern that the uniformity legislation would preempt those requirements if passed. Other states, such as Ohio and Connecticut, also have considered Proposition 65-like legislation, but no such laws have been passed in those states. Although the National Uniformity for Food Act of 2001 currently enjoys bipartisan support, it is difficult to forecast whether it will be passed into law. As mentioned above, the idea behind the legislation is not new, and some of the industry groups behind the effort have been pushing for its implementation for some time. We will continue to monitor the progress of this bill, as well as the developments in California with respect to Proposition 65 reform. 5. FDA Has a New Chief Counsel On August 20, 2001, Daniel Troy joined FDA as its new chief legal counsel. Mr. Troy's most recent position was as a partner with Wiley, Rein, & Fielding. During his tenure at Wiley, Mr. Troy wrote two books: Retroactive Legislation (1998), and Advertising and Free Speech: the Merits of Full Constitutional Protection (December, 2001 expected). National Review, National Law Journal, and American Spectator are among the periodicals in which his work has been published. In addition, Mr. Troy has appeared on CNN's Burden of Proof, and CNBC's Bull Session and Inside Business. He received his J.D. from Columbia University. Mr. Troy also is known for his First Amendment challenge to fundamental FDA regulations disallowing the promotion of off-label uses of drugs, which indicate that he may support an anti-regulatory atmosphere at FDA. His viewpoint in this regard is described in his July 23, 1999 The Wall Street Journal article, "FDA Censorship Could Cost Lives." This article suggests that pharmaceutical companies that do not promote the off-label uses of their products facilitate physician malpractice because a doctor could be committing malpractice by failing to prescribe an off-label use that could improve patient health. 6. Seven Senators Caution President Against Nominating Industry Insider to Head FDA A coalition of Democratic senators cautioned President Bush against nominating an industry insider to serve as Commissioner of the FDA in a strongly worded July 13th letter. The letter notes that it would be "unprecedented" for the FDA Commissioner to be appointed from an FDA-regulated industry, and urges the appointment of an individual with a strong scientific or medical background. According to the senators, expertise in science or medicine "has proven to be an important consideration in selecting the head of our premier public health regulatory agency." On the other hand, appointing an industry insider would "raise irresolvable conflicts of interest, undercut public confidence, and undermine the agency's worldwide reputation as the gold standard of public health regulators," they claim. The names reportedly being floated for consideration include Michael Astrue, an attorney who serves as vice president and general counsel of Transkaryotic Therapies, Inc., a biopharmaceutical company based in Cambridge, Mass., and Eve Slater, M.D., senior vice president of clinical research at Merck & Co., a New Jersey-based pharmaceutical products and services company. The letter was signed by Sens. Edward M. Kennedy (D-MA), Jeff Bingaman (D-NM), Jack Reed (D-RI), Hillary Rodham Clinton (D-NY), Barbara A. Mikulski (D-MD), Paul D. Wellstone (D-MN), and John Edwards (D-NC). All of the senators sit on the Senate Committee on Health, Education, Labor, and Pensions, which Kennedy chairs. As chair of this Committee, Kennedy will be overseeing the Senate confirmation process for the new FDA Commissioner. 7. Senator Kohl Proposes Package Tampering Law The proposed "Consumer Product Packaging Protection Act of 2001" (S. 1233), as introduced by Sen. Herb Kohl (D-WI) on July 24, 2001, prohibits the intentional unauthorized placement of any form of communication in a consumer product's packaging. The legislation addresses several complaints concerning pornographic or racist images found in cereal and frozen food packaging. Current U.S. law tacitly allows such tampering as long as the food inside the packaging is untouched; as a result, brand image may be damaged at the manufacturer's expense. Sen. Kohl's introduction of the legislation promised that "it will empower the government to investigate and punish these reprehensible acts" that lead to opening a box of cereal to find a graphic description of abortion, an anti-Semitic slogan, or a drawing of one man shooting another with the caption, "If it ain't white, waste it!" Kraft Foods has documented more than 80 such incidents in the past four years; General Mills has documented around 100. California and New Jersey already have passed laws criminalizing the intellectual contamination of product packaging. If this federal measure is passed, the penalty for violation would be a fine of up to $250,000 per offense and/or imprisonment for up to three years. The measure, S.1233, was referred to the Senate Committee on the Judiciary Subcommittee on Antitrust, Business Rights, and Competition on August 1, 2001. Supporters of the bill include the American Baker's Association, the American Frozen Foods Institute, Food Distributors International, General Mills, the Grocery Manufacturers of America, the Independent Baker's Association, Kellogg's, Kraft Foods, the National Food Processors Association, and the National Frozen Pizza Institute. 8. FDA to Monitor Dioxin as Part of FY 2002 Food Safety Plan; EU Proposes Maximum Limits for Dioxin in Food and Feed In the wake of the Environmental Protection Agency's (EPA) completion of its decade-long draft reassessment of dioxin, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has announced that it will develop a monitoring program for dioxin as part of its food safety plan for FY 2002. For the first time, surveillance of dioxin will be added to FDA's "A" list of priorities in a FY work plan. As part of the plan, FDA will test 500 food samples for dioxin. According to the USDA, dioxins are a family of 210 compounds of which 17 are considered toxic and virtually nonbiodegradable. EPA's draft reassessment concludes that 2,3,7,8-tetrachlorodibenzo-p-dioxin is a human carcinogen. About 95% of the average person's exposure to dioxins occurs through consumption of food, especially food containing animal fat. The European Commission also is taking steps to address concerns about dioxin in food. On July 20, 2001, the European Commission put forth proposals to the Standing Committee on Foodstuffs and the Standing Committee for Feedingstuffs to limit the presence of dioxin in food and feed. As part of their three-part plan, the Commission proposes to set "maximum limits" and "target and action levels" for dioxin. First, the Commission proposes to set strict maximum limits that will take effect in January, 2002. Any food or feed exceeding these maximum limits would be considered unsuitable for consumption. "Action levels" would be laid down in a Commission Recommendation as a package with the legislation establishing maximum limits. These levels would act as a tool for "early warning" of higher than desirable levels of dioxin in food and feed that would trigger investigations to identify, reduce and eliminate the source of contamination. Action levels would lie between the maximum limits and the "target levels." The "target levels" would set the ultimate goal of achieving a human exposure below the tolerable weekly intake, which the Scientific Committee on Food has established at 14 pc/kg body weight. These levels would be set as soon as more scientific data becomes available. 9. EU Adopts Sixth Amendment to the Monomers Directive and New Directive Curtailing Use of BADGE, BFDGE, and NOGE The long-awaited sixth amendment to Commission Directive 90/128/EEC (better known as the "Monomers Directive") was published in the Official Journal of the European Communities Aug. 17. The final version of the sixth amendment, designated as Commission Directive 2001/62/EC, adds over 100 new additives to the "incomplete positive list" of additives that are permitted for use in the production of food-contact plastics in the European Union. It also adds several new monomers to the list of permitted monomers and starting materials for use in food-contact plastics, modifies the specifications for some listed materials, and slightly refines the scope of the Monomers Directive (to exclude silicones). It is available on the Internet at http://europa.eu.int/eur-lex/en/dat/2001/l_221/l_22120010817en00180036.pdf . In addition, the final European Commission directive on the use of BADGE (2,2-bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ethers), BFDGE (bis(hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers), and NOGE (novolac glycidyl ethers ) in food-contact applications was adopted August 8th and published in the Official Journal of the European Communities on August 9th. This Directive, 2001/61/EC, is available on the internet at http://europa.eu.int/eur-lex/en/dat/2001/l_215/l_21520010809en00260029.pdf . The use or presence of BADGE and BFDGE in materials intended to come into contact with food has been extended for three years - until Dec. 31, 2004 - pending the submission of further toxicological data for evaluation. The directive specifically exempts large containers or storage tanks having a capacity greater than 10,000 liters, or connected pipelines, covered by heavy-duty coatings. The Commission took a somewhat stronger stance with regard to NOGE components with more than two aromatic rings and their derivatives, based upon findings of the Scientific Committee on Food. According to the SCF, it is not in a position to evaluate the safety of NOGE because of an absence of information about its potential exposure and toxicological profile. Thus, the Commission stated, "it is not appropriate to use NOGE as an additive in materials and articles intended to come into contact with foodstuffs due to its tendency to migrate in this application." Starting December 1, 2002, the quantity of NOGE with more than two aromatic rings and at lest one epoxy group, as well as its derivatives containing chlorohydrin functions and having a molecular mass less than 1000 Daltons, will not be permitted to be detectable in the finished materials and articles with a limit of detection of 0.2 mg/6 dm2. The use of NOGE in materials intended to come into contact with food must be phased out entirely by December 31, 2004. Again, the directive specifically exempts large containers or storage tanks. One provision of the directive may give rise to some questions of interpretation. Article 5 states: "The requirements of this Directive shall not apply to materials and articles [covered by surface coatings, and adhesives] which have been put into free circulation in the Community before 1 December 2002." In our view, the term "free circulation" could arguably include products that have been packed and shipped to the EU, or it could be limited to products that have cleared customs. 10. EC Delays Irradiation Proposal The EC has succumbed to pressure by consumer organizations and announced that it will delay its proposal to complete a list of foodstuffs that would be approved for irradiation. The Commission had proposed that the following groups of products be added to the list of those allowed to be treated with irradiation: (1) herbs, dried fruit and flakes, and germs of cereals; (2) mechanically recovered chicken meat, chicken offal, egg white and gum Arabic; and (3) frog legs and peeled shrimp. Currently, only dried aromatic herbs, spices and vegetable seasonings are allowed to be irradiated. In an August 8, 2001 "Communication," the Commission summarized comments from industry and consumers, eventually concluding that the only two products that have any merit for future inclusion on the list are frog legs and shrimp. While consumer organizations were the most vocal in their opposition to the proposal, some food industry groups also were opposed because they consider their current procedures to ensure good hygiene to be sufficient. Industry also was fearful that the negative image associated with irradiation would tarnish public perception of their products. The EC's communication on this issue can be found on its website at http://europa.eu.int/comm/food/fs/sfp/fi11_en.pdf. 11. SCF Releases Opinion on 14th Additional List of Substances in Food Packaging On July 13, 2001, the European Commission's Scientific Committee on Food (SCF) released its opinion on the 14th additional list of monomers and additives for food-contact materials. In May 1997, the SCF's evaluations of monomers and additives used in the manufacture of plastics used for food packaging 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 14 opinions. Those opinions are available on the SCF's Web site at www.europa.eu.int. 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"). Classification of a substance in a list from 0 through 4 generally indicates that the substance has 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 90/128/EEC (the "Monomers Directive). In its most recent release, the SCF provided its evaluation of the following substances (followed here by their reference number, chemical abstract number, and SCF List designation):
For a copy of the SCF's opinion, visit: http://www.europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf . * * * 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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