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 April 9, 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 bring you up to date on the status of discussions by House/Senate conferees to reconcile the competing versions of the anti-bioterrorism legislation passed by the two bodies, and report on SPI's submission of a letter to the conferees expressing concerns regarding potential impact of the bill on food packaging. SPI's comments to the Food and Drug Administration (FDA) on the use of tamper-evident packaging for food also are discussed. We also inform you of recent discussions on the creation of a single food safety agency or reorganization of the current agencies dealing with food safety, and the U.S. Department of Agriculture's (USDA) comments to Congress that it does not feel that USDA recall authority is necessary. Finally, we report on the latest news in the search for an FDA Commissioner; FDA's announcement of the availability of a draft guidance document on electronic records, electronic signatures, and time stamps; the publication of a United States Pharmacopeia in-process revision article on polypropylene containers in response to an SPI proposal; and other matters of interest to the Committee. Table of Contents
1. FDCPMC Expresses to Congress Concerns Regarding Potential Impact of Bioterrorism Bill On behalf of SPI's FDCPMC, we submitted letters to Rep. Billy Tauzin (R-LA), Rep. John Dingell (D-MI), Sen. Edward Kennedy (D-MA) and Sen. Judd Gregg (R-NH) expressing concerns regarding the potential impact that H.R. 3448, the Public Health Security and Bioterrorism Response Act, could have on food packaging materials. As we have been reporting to you, the House bill and its counterpart in the Senate (S.A. 2692) 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. As you may recall, the bill initially was passed by the House last December and was stalled in the Senate by the passage of a complete substitute to the House bill. Now, conferees for the House and Senate must meet to resolve the differences between the two bills. These conferees have now been appointed by both the House and the Senate, and it is our understanding that discussions are now taking place. Feedback from our contacts on the Hill so far indicates that our comments are receiving favorable consideration. We hope to be able to report a positive outcome in the near future. 2. President Bush Considering Reorganization of Agencies Dealing with Food Safety Homeland Security Director Tom Ridge, speaking at a food industry-sponsored conference, indicated that President Bush is considering reorganizing or consolidating the agencies that deal with food safety. This consideration comes as no surprise, as the September 11th terrorist attacks have again brought to the forefront concerns about the safety of the nation's food supply. Several members of Congress have been calling for the formation of an independent, single food safety agency in place of the current regulatory scheme for years, and the most recent incarnation of a bill seeking to form such an agency was introduced in the Senate just weeks after the attacks. This bill has stalled in Congress, largely due to opposition from industry. Ridge noted that the Office of Homeland Security is looking at the organization of the entire government in terms of the best way to be organized to respond to future threats of terrorism, and an analysis of the food safety agencies simply is part of that effort. Apparently, the White House is not necessarily considering the creation of a new agency, but rather a coordination and consolidation of existing agency functions. Ridge pointed out that the government is approaching the issue carefully, because a revamping of the system could result in loss of expertise, an argument that repeatedly has been made by the food industry. Remarks by FDA Deputy Commissioner Lester Crawford in response to Ridge's comments indicate that he is open to the idea of creating a single food safety agency. Dr. Crawford said that the division of food responsibilities between USDA and FDA is "curious," and that it is time to seriously consider the implications of creating a single food safety agency. 3. USDA Official Tells Senate Committee that USDA Does Not Need Recall Authority Examination of FDA and USDA ability to respond to threats against the food supply since September 11th also have renewed calls in Congress to provide the agencies with recall authority. With the exception of infant formula, FDA currently cannot order a food recall; USDA has no recall authority. The two agencies traditionally have been opposed to having this authority, pointing out that the current system of recalling contaminated products works. USDA's thoughts on the matter were confirmed during a Senate subcommittee conference March 20th. During a meeting of the Senate Appropriations Subcommittee on Agriculture, Rural Development and Related Agencies, Senate lawmakers and the USDA's Under Secretary for Food Safety Elsa Murano debated the issue of USDA recall authority. Dr. Murano told the Senators that USDA recall authority is unnecessary because the Agency already has emergency detention authority, and the current voluntary system for removing contaminated products from the shelves works. She pointed out that there had been only one instance when a company refused to recall a product. USDA then used its detention authority and the company agreed to recall the product. Senator Durbin pointed out that, in 1999 and 2000, only about one-fourth of recalled meat and poultry products was recovered. Dr. Murano responded that there would not be a greater recovery of products if USDA had recall authority. She then provided an example of how 31% of households involved in an ice cream recall knew there was a recall, but ate the product anyway. 4. SPI Submits Comments to FDA on Use of Tamper-Evident Packaging for Food On March 11, 2002, SPI's FDCPMC submitted comments to FDA in response to the Agency's request for input on the use of tamper-evident packaging for food. As you may recall, in a January 9, 2002 Federal Register notice announcing 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 (67 Federal Register 1224), FDA requested 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 was 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, and sought information on the practicality of using tamper-evident packaging with the broad spectrum of foods presently in commerce. In our comments to the Agency, we expressed SPI's view that companies in the food industry are in the best position to determine whether and how packaging may be most effective in assuring food safety. We explained that "the universe of food products and packaging options is so extensive and diverse that generalizations as to the applicability of tamper-evident packaging are not possible. Some food products are sold in bulk, with no packaging, while others have packaging that already is tamper-evident. This is a subject which FDA properly can and should entrust to the judgment of the food and packaging industries." Thus, we stated, FDA should not specify particular applications in which tamper-evident packaging would be appropriate or the packaging options that should be selected; this is best left to industry, which is more familiar with the range of food products and types of packaging. These concerns were echoed by others who submitted comments to FDA. Commenting on the FDA guidance document generally and not just on the subject of tamper-evident packaging, the Food Marketing Institute cautioned the Agency against instituting measures that "are not appropriate for every segment of the food industry or even for every company within a given segment of the food industry." The United Fresh Fruit and Vegetable Association commented that tamper-evident packaging is not feasible for a majority of the produce products on the market. 5. Sundwall Lead Candidate for FDA Commissioner David Sundwall appears to be the lead candidate for the FDA Commissioner post at the moment, and rumors are that the White House will announce his nomination by the end of this month. Dr. Sundwall currently is the President of the American Clinical Laboratory Association. Prior to this position, he was Vice President and Medical Director of American Healthcare System, the largest coalition of not-for-profit multi-hospital systems in the United States. He also has extensive experience in government. In late March, President Bush announced his choices for two other top health policy posts. Richard Carmona, a trauma surgeon from Arizona, was named Surgeon General. Elias Zerhouni, a medical administrator from Johns Hopkins University, will head the National Institutes of Health. 6. FDA Announces Availability of Draft Guidance on Aspects of Electronic Submissions In the March 20, 2002 Federal Register (67 Fed. Reg. 12999), FDA announced the availability of a draft guidance document entitled "Draft Guidance for Industry on Electronic Records; Electronic Signatures, Time Stamps." The draft guidance addresses issues pertaining to computer generated time stamps in computer systems used to create, modify, maintain, archive, retrieve, or transmit electronic records and electronic signatures subject to 21 C.F.R. Part 11. The regulations in Part 11 set forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The draft is available on the Agency's website at http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1542_gdl0001.pdf. FDA is accepting comments on the draft guidance until June 18, 2002, and we are reviewing the guidance to determine whether there are issues on which SPI should comment. 7. USP Publishes In-Process Revision Article on Polypropylene Containers In the March-April 2002 issue of Pharmacopeial Forum, an in-process revision article on polypropylene containers was published for the third time. This article reflects the culmination of the United States Pharmacopeia's (USP's) thinking on SPI's proposal to establish a monograph by which resin suppliers may demonstrate that polypropylene containers are interchangeably suitable for packaging dry and liquid oral dosage forms, and ophthalmic dosage forms. Because of concerns expressed by the FDA regarding this proposed monograph, a meeting was held between USP and FDA on March 22, 2002. We have long known that it is the view of the FDA staff that an interchangeability protocol for sterile liquid dosage forms is inappropriate due to the safety and stability concerns attendant to the routes of administration (as opposed to oral liquid and solid dosage forms). The routes of administration FDA is most concerned with are such as transdermals, injectables, and ophthalmics. FDA believes that a case-by-case analysis of resin changes in containers for sterile liquid dosage forms is required to ensure safety, and, consequently, has proposed changes to 21 C.F.R.§ 314.70 to require drug manufacturers to submit supplements for such changes. See 64 Fed. Reg. 34608 (June 28, 1999). Specifically, the proposed rule alters the reporting category applicable to changes within the container/closure system for sterile liquid drugs (like ophthalmics) such that the manufacturer would need to file a supplement with FDA even if the change is made based on a showing of equivalency pursuant to a protocol in the approved new drug application or published in an official compendium. In its container closure guidance, FDA identifies those routes of administration that it considers of highest concern, and for example, makes no distinction among ophthalmics and injectables in requiring certain suitability data. These safety concerns also have been discussed with industry as FDA develops guidance on post-approval change requirements for packaging ("PACPAC"). USP's position, which was voiced at the meeting with FDA, is that the available data fully support inclusion of ophthalmic dosage forms in the recommended interchangeability procedure for polypropylene. This position is reflected in the most recent issue of Pharmacopeial Forum, in which the proposed polypropylene containers monograph was republished with changes. Specifically, the proposal is now more limited in scope (a concession made by USP at the meeting with FDA), by covering only "dry and liquid oral dosage forms and ophthalmic dosage forms" instead of all dry and liquid dosage forms (e.g., injectables). The monograph also now includes a section entitled "Polypropylene containers for ophthalmics" which contains language acknowledging that, because factors other than those addressed in the monograph may also affect the suitability of polypropylene (e.g., conditions of storage), the "suitability of a specific polypropylene must be established by appropriate testing." This phrasing also appears in the existing "Containers for Ophthalmics - Plastics" section that is found preceding the requirements outlined in the polyethylene containers monograph in Chapter <661> of USP 25. Meanwhile, it is our understanding that FDA has indicated to USP that it would like to more closely review the round robin data submitted by SPI. Further, although USP has limited the scope of the proposal, it also is our understanding that FDA will continue to register objections to USP's going forward with the proposal in its present form. 8. Michigan State University Holds DMF Workshop On March 25-27, 2002, the Michigan State University (MSU) School of Packaging sponsored a workshop in Crystal City, Virginia on Drug Master Files (DMFs). As many of you know, DMFs may be filed with FDA to maintain confidential information on products that are referenced as part of New Drug Applications (NDA). The Conference focused on advising attendees on how to create a seamless interface between their company's DMFs and any NDAs in which product contained in the DMF is referenced. Speakers at the conference included Dr. Hugh Lockhart, Professor at MSU School of Packaging, who acted as Chairman of the Planning Committee and moderator for the conference, Dr. Arthur B. Shaw, of FDA's Center for Drug Evaluation and Research (CDER), who provided general background information on DMFs, and John B. Dubeck, Esq., of Keller and Heckman LLP, who spoke regarding the role of DMFs in FDA's approval process for new drugs. In addition, Dr. Frank O. Holcombe, Jr., Associate Director for Chemistry of CDER's Office of Generic Drugs, provided his thoughts on FDA's expectations for what should be included in Type III DMFs, which are intended to cover materials used to package drug products. One of the main reasons behind holding the conference was to circulate "Proposed Guidelines for the Content of Type III Drug Master Files: Packaging Materials and Components," which should be available soon online at http://www.dmfworkshop.msu.edu. The proposed guidance was presented as a white paper by the workshop's Type III DMF Subcommittee (I represented SPI on this Subcommittee). The paper includes a glossary of relevant terms, guidelines for information that should be submitted as part of the DMF to support an NDA, example letters of authorization, and example DMF sections. The goal of the Subcommittee is to solicit comments on the white paper from industry and FDA, and, ultimately, to finalize the document as industry guidance. Although the guidance may never be adopted formally by FDA, the drafters of the guidance are working in conjunction with industry and the Agency to finalize the document, and the hope is that FDA eventually would be willing to reference the document as appropriate guidance upon which industry may rely to create, file, and maintain Type III DMFs with FDA. 9. Codex Committee Delays Action on Proposal to Remove Irradiation Dose Limit The Codex Committee on Food Additives and Contaminants has postponed action on the proposal to remove the current 10 kiloGray dose limit on food irradiation, citing a need for evaluation of studies reporting toxic effects of byproducts formed during irradiation. Not surprisingly, the proposal had been opposed by Public Citizen and other consumer interest groups. The Committee will not reconsider the proposal until sometime next year to allow time for complete review of the studies. * * * 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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