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 February 4, 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 provide an update on the status of the bioterrorism prevention bill that appeared to be moving swiftly through Congress in December, but now has been stalled in the Senate by the passage of a complete substitute to the House bill. We also discuss a new guidance document issued by the Food and Drug Administration (FDA) on preventive measures that operators of food establishments can take to minimize the risk of tampering or criminal or terrorist actions directed at food. In issuing this document, FDA also requested information from stakeholders as to whether the guidance document should be revised to include the recommendation of the use of tamper-evident packaging for food. Information on the latest candidate for the FDA commissioner slot also is provided. In connection with the move of some FDA personnel to new quarters in College Park, Maryland, we provide the new mailing address for the Office of Food Additive Safety, and let you know that the address for courier deliveries remains the same. Finally, we inform you of recent developments in the European Union with regard to the establishment of the new European Food Safety Authority, the adoption by the European Commission's Scientific Committee on Food of its 15th and 16th additional lists of monomers and additives for food-contact material, and other matters of interest to the Committee. Table of Contents
1. Passage of Bioterrorism Prevention Bill Stalled by Senate The bioterrorism prevention bill that moved swiftly through the House in early December was slowed by the Senate with the passage of a complete substitute to the House bill. You may recall that the House bill, H.R. 3448 ("Public Health Security and Bioterrorism Response Act of 2001"), was approved overwhelmingly by the House on December 12, 2001, only a few days after being introduced. On December 20th, the Senate passed S.A. 2692, a complete substitute to the House bill. With respect to the food-related provisions of the bill, S.A. 2692 adds, among other things, general provisions to expand and upgrade security at various agencies to guard the facilities against potential bioterrorist attacks and prevent the theft of biological agents and toxins. S.A. 2692 also adds provisions to provide funding to allow FDA and the U.S. Department of Agriculture to increase their inspection capacity, and provisions providing for research and training to enhance food safety and security. The provisions in S.A. 2692 that would amend the Federal Food, Drug, and Cosmetic Act to provide FDA with the authority to detain food, impose new facility registration requirements, and require at least 24 hours advance notice of importation, are substantially similar to those in H.R. 3448. As we explained in our December 20, 2001 letter to the Committee, the terminology used in some provisions that would provide FDA with enhanced enforcement authority might be interpreted in some cases as extending to food packaging. Conferees for the House and Senate now must meet to hammer out the differences between the two bills. The Senate appointed conferees in late December, but the House has not done so yet. Since the House will be out of session until February 5th, it will be at least several days before we see further action on this legislation. 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. 2. FDA Issues Guidance Document on Prevention of Food Tampering, Requests Comments from Industry on Use of Tamper-Evident Packaging for Food On January 9, 2002, FDA announced the availability of a guidance document discussing the preventive measures that operators of food establishments can take to minimize the risk that food under their control will be subject to tampering or criminal or terrorist actions. See 67 Federal Register 1224 (January 9, 2002). In the document, entitled "Guidance for Industry: Food Producers, Processors, Transporters, and Retailers: Food Security Preventive Measures Guidance," FDA encourages all sectors of the food system, including farms, fishing vessels, processing and packing facilities, and retail and food-service establishments, to review their current procedures and controls in light of the potential for tampering or criminal or terrorist actions and make appropriate improvements. The guidance is divided into seven sections that relate to individual components of a food establishment operation: management of food security; physical security; employees; computer systems; raw materials and packaging; operations; and finished products. Of most interest to packaging suppliers, the Federal Register notice states that FDA is seeking comments from stakeholders as to whether the guidance document should be revised to include the recommendation of the use of tamper-evident packaging for food as an additional preventive measure. FDA is particularly interested in information on the effectiveness of the various methods of tamper-evident packaging in minimizing the risk that foods will be subject to tampering or criminal or terrorist actions. FDA also is seeking information on the practicality of using tamper-evident packaging with the broad spectrum of foods presently in commerce. The Agency is seeking comments by March 11, 2002. The document can be found on FDA's website at http://www.fda.gov/OHRMS/DOCKETS/98fr/01d_0583_gdl0001.pdf. A separate guidance aimed at food importers also was issued by the Agency, and can be found on the website at http://www.fda.gov/OHRMS/DOCKETS/98fr/01d_0583_gdl0002.pdf. Please let us know if there are aspects of this tamper-evident packaging issue on which you believe the Committee should comment. 3. Alastair Wood Nomination for FDA Commissioner Rumored to Face Strong Drug Industry Opposition Alastair Wood, Assistant Vice Chancellor at Vanderbilt University, continues to be identified by some sources as the current lead candidate for the FDA Commissioner post. Dr. Wood is a physician who also teaches medicine and pharmacology at the university. He has been a member of several FDA advisory committees on various human drug issues. Dr. Wood's background likely will appeal to Sen. Edward Kennedy (D-MA), who is the head of the Congressional committee that will oversee the confirmation of the next FDA Commissioner. You may recall that Kennedy has stated that he will oppose any candidate from an FDA-regulated industry, which Wood clearly is not. We have heard, however, that Wood's history of endorsing strong regulatory control over the pharmaceutical industry continues to draw significant criticism from the industry and may even derail the nomination. Two names that previously were said to be candidates for the top slot, Lester Crawford and David Sundwall, are now rumored to be in the running for Deputy Commissioner. It has been reported that Crawford would be a good counterpart to Wood, since Crawford is an expert on food and veterinary drugs, while Wood has vast knowledge in the field of human pharmaceuticals. It is not clear whether the controversy over Wood's nomination will affect the choice for Deputy Commissioner. 4. OFAS Stays in Washington, but Mailing Address Moves to College Park As we have been reporting to you, FDA is moving many of its functions to College Park, Maryland. The Office of Food Additive Safety (OFAS), however, does not yet have office space in College Park. OFAS is the FDA unit that provides clearances for food-contact substances. You may recall from our previous letters that mail destined for OFAS staff at the 1110 Vermont Avenue, N.W., Washington, D.C., location has been sent to 200 C Street, S.W., Washington, D.C. 20204, to be screened for security purposes before being forwarded to Vermont Avenue. The C Street mailroom was initially scheduled to move to College Park on December 14, 2001, but the move was delayed to January 25, 2002. The move did proceed partially as scheduled on that date, and OFAS now has a new mailing address, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. FDA, however, has left a small contingent on C Street to continue, for now, to receive all hand-delivered filings, including Federal Express and other courier deliveries. Although OFAS' mail is being routed to College Park, it appears that it will be quite some time before OFAS personnel follow. 5. European Council of Agriculture Ministers Adopts Legislation Setting Up Food Safety Authority On January 21, 2002, the European Union's Council of Agriculture Ministers adopted legislation setting up the new European Food Safety Authority (EFSA). This key step follows the European Council's (EC) decision last December to temporarily locate the EFSA in Brussels. The EC is now concentrating on recruiting personnel so that the EFSA can become operational as soon as possible. The EC next will nominate members for the fifteen-member Management Board. Once the Management Board has been established, the Board will begin its search for an Executive Director. Appointments for the Management Board and Executive Director position will need to be approved by the European Parliament. Independent scientists for the EFSA's Scientific Panels will need to be selected and appointed before the Authority can become fully operational. These Panels will replace the existing scientific committees dealing with risk assessment in food safety matters, including the Standing Committee for Foodstuffs, the Standing Veterinary Committee, the Standing Committee for Feeding Stuffs, and the Standing Committee on Plant Health. Of the eight permanent EFSA scientific panels to be established, there will be a separate panel on food additives, flavourings, processing aids and materials in contact with food. The current EU system for scientific advice will continue to function until the new system is in place. For further information on the EFSA, visit its new website at http://www.efsa.eu.int/. 6. SCF Releases Opinion on 15th and 16th Additional List of Substances in Food Packaging The European Commission's Scientific Committee on Food (SCF) has adopted its 15th and 16th additional lists of monomers and additives for food-contact materials. You may recall from our previous letters that, 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 published its results in a series of 16 opinions. Those opinions are available on the SCF's website 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 releases, 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 15th additional list, visit: http://www.europa.eu.int/comm/food/fs/sc/scf/out114_en.pdf; the 16th additional list is available at http://www.europa.eu.int/comm/food/fs/sc/scf/out115_en.pdf. 7. Michigan School of Packaging to Hold DMF Workshop On March 25-27, 2002, the School of Packaging at Michigan State University will hold a Drug Master File (DMF) Workshop. The Workshop will be held near Washington, D.C. at the Marriott Crystal City Gateway in Arlington, Virginia. According to the announcement, the workshop will provide instruction on creating DMFs that "adds to the value of your product, avoid[s] FDA deficiency letters, help[s] your customer get faster approval of [New Drug Applications], and help[s] your supplier maintain DMFs that will aid quick FDA approval of your new product." For further information on the workshop, visit the University's website at http://www.DMFWorkshop.msu.edu. * * * 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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