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 March 14, 2002
(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 that Dr. Lester Crawford has been named Deputy Commissioner of the Food and Drug Administration (FDA) and provide an update on the search for the top position at the Agency. We also bring you up to date on the status of the appointment of House/Senate conferees to reconcile the competing versions of anti-bioterrorism legislation passed by the two bodies. Both of the bills would expand FDA's authority with possible unintended consequences for food-contact materials. Recent developments in the area of food irradiation also are discussed. Finally, we report on activities in the European Union, including the passage of the seventh amendment to the Monomers Directive, the issuance of a revised directive on BADGE, BFDGE, and NOGE, and action by the EU and Norway on nonylphenol and its ethoxylates. Table of Contents
1. Lester Crawford Named FDA Deputy Commissioner; Alastair Wood Apparently Out of Running for Top Slot On February 25, 2002, Health and Human Services Secretary Tommy Thompson named Dr. Lester M. Crawford to serve as deputy commissioner of the Food and Drug Administration. Dr. Crawford will now be the senior official at FDA pending the appointment of a permanent commissioner of food and drugs. Prior to the deputy commissioner post, Dr. Crawford was most recently the head of the Center for Food and Nutrition Policy at Virginia Tech. He also served as administrator of the U.S. Department of Agriculture's Food Safety and Inspection Service from 1987 to 1991 and as director of FDA's Center for Veterinary Medicine from 1978 to 1980, and again from 1982 to 1985. The Bush administration also has apparently succumbed to pressure from the drug industry and eliminated Alastair Wood from consideration for FDA commissioner. The drug industry had strongly criticized Wood's history of endorsing increased regulatory control over the pharmaceutical industry. Now that Dr. Crawford is in place as deputy commissioner, the Bush administration is not facing as intense pressure to fill the top slot. Thus, it may be some time before we see a nomination. 2. House Appoints Conferees for Bioterrorism Legislation The House of Representatives has now appointed its conferees on the bioterrorism prevention legislation. You may recall from our previous letters that the bill, initially passed by the House on December 12, 2001, was stalled in the Senate by the passage of S.A. 2692, a complete substitute to the House bill. The Senate appointed conferees in late December shortly after it passed the amended version, but the House did not appoint conferees until late February. Conferees for the House and Senate now must meet to hammer out the differences between the two bills. Once the differences are reconciled in conference, the new bill must be passed by the House and Senate before going to the President for signature. We expect that the conference will proceed rather quickly. It is being reported that Rep. Billy Tauzin (R-LA), chair of the House Energy and Commerce Committee and a sponsor of the bioterrorism prevention bill, has told conferees that he wants to send the legislation to the President by the end of March. As we have reported previously, while the bills differ in some respects, they include essentially identical provisions expanding FDA authority in areas such as temporary detention of possibly hazardous foods and advance notice to FDA of food imports. If these provisions become law with their current language, it is possible that they could be interpreted (probably mistakenly) as extending to food packaging and other food-contact materials. The law of unintended consequences may well come into play in the case of this legislation, as is often the case when Congress gets involved. 3. FDA Makes Fighting Food Bioterrorism Top Food Safety Priority for 2002 FDA's Joseph Levitt, director of the Agency's Center for Food Safety and Applied Nutrition, says that FDA's top food safety priority for 2002 will be protecting the food supply from bioterrorism. As part of the plan, the Agency will concentrate on inspections, particularly of food imports, as a means of preventing bioterrorism. FDA also will be working closely with other federal, state and local agencies to avert threats of contamination. Also as part of increased efforts to prevent bioterrorism since the September 11th terrorist attacks, Leavitt has been advising the Bush administration on ways to protect the U.S. food supply from threats. 4. Amendment to Farm Bill Would Broaden Definition of Pasteurization to Include Irradiation Much to the chagrin of the consumer interest group Public Citizen, a provision in the Senate version of the Farm Bill, Section 1079E of H.R. 2646.EAS, would redefine the term "pasteurization" in any Federal law to include any treatment approved by FDA that has been shown to reduce the level of harmful microorganisms in the food. Under this broad definition, irradiation would be included in the definition of pasteurization. If this provision remains in the final version of the bill that becomes law, it would allow the food industry to use on its labels terms such as "electronically pasteurized" as an alternative to those containing the word "irradiation." As we have explained in previous letters, the food industry would prefer to use terms such as "electronically pasteurized" rather than those containing the word "irradiation," due to concerns that the latter term unnecessarily alarms consumers. On the other hand, consumer interest groups such as Public Citizen feel that use of any term other than "irradiation" is misleading to consumers. Not surprisingly, Public Citizen is lobbying hard against the language in the Farm Bill. The food industry notes that companies would still have to disclose on labels that products have been irradiated, and display the radura symbol. The redefinition, however, would provide companies with more flexibility in using additional language to describe the irradiation process. 5. EU Adopts Seventh Amendment to the Monomers Directive The seventh amendment to Commission Directive 90/128/EEC (better known as the "Monomers Directive") was published in the Official Journal of the European Communities February 28, 2002. The final version of the seventh amendment, designated as Commission Directive 2002/17/EC, adds several new additives to the "incomplete positive list" of additives that have been cleared at the European Union (EU) level under the Monomers Directive for use in the production of food-contact plastics. It also adds several new monomers to the list of permitted monomers and starting materials for use in food-contact plastics and modifies the specifications for some listed materials. It is available on the internet at http://www.europa.eu.int/eur-lex/en/dat/2002/l_058/l_05820020228en00190024.pdf. 6. EU Issues Revised Directive on BADGE, BFDGE, and NOGE The EU also has issued a revised 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. You may recall that a "final" directive, 2001/61/EC, was adopted on August 8, 2001 and published in the Official Journal of the European Communities on August 9, 2001. The new Directive, 2002/16/EC, was adopted February 20, 2002 and published in the Official Journal on February 22, 2002. The new Directive repeals the August 8th version and clarifies an issue of interpretation raised in the first version. Specifically, Article 5 of the August 8th version stated: "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. This ambiguity has been corrected in Article 5 of the February 20th version, with the stipulation that "[t]he requirements of this Directive shall not apply to materials and articles covered by surface coatings, and adhesives . . . which are brought into contact with foodstuffs before 1 March 2003. These materials and articles may continue to be placed on the market provided that the date of filling appears on the materials and articles . . . ." Thus, the transitional period applies to all cans filled prior to 1 March 2003, provided the date of filling is affixed on the article. To account for the re-issuance of the Directive, the limitation on NOGE components will now take effect March 1, 2003 rather than the December 2, 2002 date specified in the August 8th version. The February 20th Directive is available on the internet at http://europa.eu.int/eur-lex/en/dat/2002/l_051/l_05120020222en00270031.pdf. 7. EU and Norway Take Action on Nonylphenol and its Ethoxylates As you may know, there have been developments in Europe over the past few months concerning nonylphenol (NP) and nonylphenol ethoxylates (NPE). Most recently, Norway imposed restrictions, effective January 1, 2002, on nonylphenol, octylphenol, and their ethoxylates. Specifically, Norway banned the import, export, sale, and use of these substances and preparations containing them, except in paints, varnishes, and lubricating oils, or for research purposes. The regulations, however, do not apply to solid articles made with the substances. We have not been able to find documentation of the rationale for these restrictions. We believe, however, that they probably are related to the EU's recommendation (not yet implemented) of similar restrictions, which is discussed below. Norway is not an EU Member State, but it does participate in EU discussions of chemicals regulation. Furthermore, as a non-member of the EU, Norway can take its own action without waiting for the EU to pass legislation. Such independent action, however, may be limited in some cases by Norway's obligations under the European Economic Area (EEA) Agreement. Preceding Norway's regulations, on November 7, 2001, the European Commission published a recommendation for the EU to consider restrictions on the marketing and use of NP and NPE in certain applications and on the production of NP and NPE and additives based on them. We expect the Commission to present a proposal reasonably soon for an amendment of Directive 76/769/EEC ("Restrictions on the marketing and use of certain dangerous substances and preparations") to impose the recommended restrictions. This process, however, involves both the European Council and the European Parliament, and may take up to two or three years. The European Commission's recommendation for restrictions on NP and NPE emerged from a review of the substances based on their placement on a priority list for review under Regulation 793/93/EEC on the evaluation and control of the risks of "existing substances." The initial report from this review was issued in April 2001 by the UK, which was the EU Member State selected as the "rapporteur" for the risk assessment of NP and NPE. The UK report did not recommend restrictions, finding no need for action on the basis of possible risk to human health, and called only for additional research on certain potential environmental impacts. The European Commission's Scientific Committee on Toxicity, Ecotoxicity, and the Environment (CSTEE), in a pre-release review of the UK report, concluded that human exposure to the substances might be underestimated because of insufficient data. The CSTEE also discussed the possibility that NP might affect the endocrine system and questioned whether authorities should wait for additional exposure data before introducing risk management steps. The European Commission apparently agreed with the CSTEE that restrictions should be considered even before more information on exposure is available. This recommendation also should be viewed in the context of the Commission's ongoing review of suspected "endocrine disruptors." NP is one of 66 (out of 564 evaluated) "Category 1" substances selected for priority evaluation as potential "endocrine disruptors," although NP was classified as of "medium exposure concern," while 60 of the "Category 1" substances were classified as of "high exposure concern." This review of NP also may affect the consideration of the restrictions recommended by the Commission on the basis of the "existing substances" review. We are monitoring this situation closely and will continue to keep the Committee updated on new developments in this area. * * * 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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