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 General Counsel's Report to The Society of the Plastics Industry, Inc.'s (SPI) Food, Drug, and Cosmetic Packaging Materials Committee June 27-28, 2002 Meeting Baltimore, Maryland June 27-28, 2002 INTRODUCTION We are pleased to present this report on the status of matters in which we have been involved or which we have monitored on behalf of The Society of the Plastics Industry, Inc.'s (SPI) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) since the November 29-30, 2001 meeting of the Committee. Table of Contents
1. SPI Obtains Statements of Congressional Intent that the Full Scope of Expanded Food and Drug Administration Authority under the Bioterrorism Prevention Legislation Passed by the House and Senate Does Not Apply to Food-Contact Materials As we have been reporting to you, on May 22, 2002, the House adopted the report of the conference committee on H.R. 3448, the Public Health and Bioterrorism Response Act. The Senate adopted the report on May 23, and it is expected that the President will sign the measure into law upon receipt. Once signed into law, H.R. 3448 will amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (PHSA) to greatly expand the ability of the Secretary of Health and Human Services (HHS) to prevent or respond to public health emergencies resulting from terrorist attacks. As we have indicated previously, the report includes provisions expanding Food and Drug Administration (FDA) authority in areas such as temporary detention of possibly hazardous foods and advance notice of food imports to FDA. You may recall that we submitted letters, on behalf of this Committee, 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 unintended impact that the legislation could have on food-contact materials as a result of extending FDA's authority over "articles of food," which could be interpreted under the Federal Food, Drug, and Cosmetic Act as including food-contact materials that are food additives. Working with Susan Howe, SPI's Senior Technical Director, Worker and Product Safety, and staff director of the Committee, and Maureen Healey, SPI's Vice President of Government Affairs, we urged staff for the House/Senate Conference Committee on the bill to include language in the Conference report stating Congressional intent not to extend provisions such as advance notice of food imports and registration of food facilities to food-contact materials. The Conference Committee staff included the following language in the report (available at http://energycommerce.house.gov/107/pubs/conference3448.htm): "The Managers intend that the requirements of this section [307-prior notice of imported food shipments] 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." We know that this language was aimed at limiting the scope of the bill with respect to food-contact materials. The statement, however, applies only to the import notification provision of the bill. The language also could be subject to varying interpretations. To clarify Congressional intent, we submitted language for technical corrections to the report. Our request for clarification was honored with respect to the import notification provision by Rep. John Shimkus (R-IL), the manager of the bill in the House, who provided the following comments, which appeared in the May 24 Congressional Record: "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." Unfortunately, despite our submission of language clarifying that section 305 regarding registration of food facilities is not intended to apply to facilities engaged in the manufacture or distribution of food packaging materials or other food contact substances as long as they are not otherwise intended for use in food, this language was not included in the technical corrections to the report. Nevertheless, we are reasonably optimistic that FDA will not misinterpret the registration provision, which uses the terminology "food for consumption," and not just "articles of food," in identifying the facilities that are intended to be registered. Other provisions in the report for additional FDA authority, such as administrative detention of "food" and additional access to companies' records, are conditioned on a "reasonable belief" by FDA that the product "presents a threat of serious adverse health consequences or death to humans or animals." As we have discussed before, this limitation makes it difficult and, in our view, inadvisable to ask that packaging materials be excluded. Therefore, we believe we have obtained clarification of the provision in the bill (advance notice of import) that was most susceptible to misinterpretation with respect to food-contact materials. 2. Update on Food-Contact Notification (FCN) Program a. FDA Publishes Final Rule for FCN Program A final rule amending the food additive regulations to specify the requirements and procedures applicable to the FCN program was released by FDA and published in the Federal Register on May 21, 2002 (see 67 Fed. Reg. 35724). Although FDA has been accepting FCNs under the program since January 2000, the program will be officially implemented when the final rule becomes effective on June 20. The final rule makes few substantive changes to the version issued as a proposed rule on July 13, 2000 (see 65 Fed. Reg. 43269). The Agency did make some modifications in response to comments submitted on the proposed version by this Committee. Among the more notable changes is a revision of 21 C.F.R. § 170.104(b) to clarify that, provided a filing is complete when received, the 120-day review period begins upon receipt by FDA of the FCN, not the date FDA "accepts" the notification as FDA originally proposed. In addition, the Agency revised Section 170.101(c) to clarify that the Agency's good laboratory practice regulations do not apply to migration studies or other non-clinical laboratory studies. One significant aspect of the final rule is that each notification filed after June 20 must be accompanied by FDA Form 3480. According to FDA, the form has been revised to minimize duplication of information required elsewhere in a notification in response to industry comments; however, FDA retained the form as a required element of a complete FCN. Thus, the final rule apparently will allow FDA to reject a notification for failure to include the form, even if the required information appears elsewhere in the notification. In the preamble to the final rule, FDA notes that the guidance documents have been revised to provide cross-references to the form, in order to assist manufacturers and suppliers in completing FDA Form 3480. Although not specifically addressed in the preamble, a completed FDA Form 3479 also is mandatory for notifications for food-contact substance formulations under Section 170.106. It also is notable that FDA refused to include a provision in the final rule assuring that the Agency will continue to provide letters confirming that notifications have become effective. FDA noted that, under the Federal Food, Drug, and Cosmetic Act, no Agency action is required for a notification to become effective. The Agency recognized that such letters have value to industry, but was concerned that issuance of such letters could potentially consume limited resources that may otherwise be used to complete timely reviews of FCNs. In practice, FDA has consistently issued final letters for effective notifications; accordingly, it is likely that FDA will continue to do so. In fact, FDA acknowledged in the preamble of the rule that, as long as there are necessary resources to do so, the Agency will provide letters indicating that its review of a notification is complete and that the notification is effective. b. Comments Sought on FCN Licensing In addition to the FCN final rule, FDA published an advance notice of proposed rulemaking, seeking input on whether the Agency should establish regulations permitting the licensing of the rights to manufacture and market a food-contact substance for the use that is the subject of an effective FCN (see 67 Fed. Reg. 35764 (May 21, 2002)). The request stems from a comment, submitted by the American Plastics Council (APC), requesting that FDA issue regulations permitting manufacturers to transfer or license their rights under an FCN to third parties. Because FDA deemed this comment to be outside the scope of the proposed rules on the FCN program, the Agency did not address the APC comment in the final rule. Currently, notifications are effective for only those manufacturers and/or suppliers identified in the notification. Customers of any manufacturer or supplier identified in the notification also may rely on the effective notification. However, other manufacturers of similar or identical food-contact substances that are not covered by the effective FCN must submit their own notification and wait 120 days for the FCN to become effective before marketing the substance. FDA has requested comments on the proposal by Aug. 5, 2002, and is particularly interested in answers to the following questions:
On the surface, one might conclude that the ability to license or transfer the rights to other companies obviously is a benefit to industry. Ultimately, that may be the consensus; but we feel that the issue merits careful consideration. First, we note that transferability may not be that significant a benefit. It is already clear that FCNs can be "transferred" to successor corporations in the context of a merger or acquisition. This can be accomplished merely by means of a letter to FDA. We consider it equally clear that an effective FCN may be relied upon by the notifier's corporate parents, subsidiaries, and other corporate affiliates. Furthermore, third parties can obtain all of the non-confidential documentation supporting an effective FCN, and can use the information to obtain their own FCN for the same food-contact substance. If the "me too" FCN is well-constructed, it is likely to become effective 120 days after receipt by FDA. Thus, the right to transfer or license may not have great significance. In addition, we consider it to be inevitable that FDA will feel the need to establish rules and procedures for a transfer and licensing system. As with legislation, regulation always involves the risk of unintended consequences. We will not speculate at this time as to the possible nature of such consequences in this case, but we strongly recommend that industry consider the possibility of regulatory action that would adversely affect the existing FCN program. c. FDA Issues Final Guidance on Chemistry and Toxicology Recommendations and Administrative Guidance for FCNs In April and May, FDA released revised versions of the chemistry and toxicology guidelines and administrative guidance for FCNs, respectively. The recommendations are fundamentally unchanged from the last versions of the documents, but the Agency has clarified and updated some of the information found in the guidelines. With regard to the toxicology guideline, the discussion in Section II ("Exposure Estimates") now makes it clear that toxicology data are not needed at a dietary level of 0.5 part per billion (ppb) or lower, not only for the use of a new food-contact substance, but also for incremental exposures for substances for which there are existing clearances, i.e., in effect, an incremental change of 0.5 ppb is effectively no change. In Section IV ("Safety Testing"), FDA still indicates a preference for the mouse lymphoma tką assay (as compared to in vitro chromosomal damage) (although this is not a change, we felt it was noteworthy.) Also, there is now a separate section that states explicitly that the dietary exposure thresholds for the various categories of toxicology test requirements for biocides are one-fifth of those for other types of food-contact substances. In Section V ("Organization of the Safety Information"), FDA now is more explicit about the recommended organization of safety information, which is as follows: Section I - Comprehensive Toxicology Profile; Section II - Original Reports of Safety Studies; Section III - Published Literature; and Section IV - Appendices ("other information" and literature searches). Section VII ("Comprehensive Toxicology Profile") of the guidance no longer contains, with regard to risk assessments for carcinogenic constituents, FDA's previous reference indicating that the risk needs to be below 10-8; there is no reference at all now specifying what a safe level needs to be. Hopefully, this indicates that FDA will continue to assess carcinogenic constituents on a case-by-case basis. Further, FDA now clarifies in Section VIII ("FDA's Views of the Relevance of Various Types of Safety Studies in Notifications") that only studies relevant to the safety assessment of a substance in food need to be discussed, i.e., data from studies using routes of administration other than oral are not of value unless effects at distill sites are observed. Finally, there is now a (little) bit more guidance regarding the significance of the results of genetic toxicity tests. FDA explains that factors that should be considered in determining whether results of genetic toxicity studies indicate a potential safety concern for a food-contact substance include (1) other available safety data such as bioassays; (2) the quality of the genetic toxicity studies; (3) the array of positive and negative genetic toxicity test results; and (4) the chemical structure of the substance. The chemistry guideline now contains a new introductory section providing background information on food-contact substances. Section II ("Chemistry Data") also has a new introduction, focusing on uses resulting in exposures <0.5 ppb. There also are some clarifications in the appendices of the chemistry guidance. Appendix II ("Selected Migration Testing Protocols") of the guideline that discusses Condition of Use C testing conditions now clarifies that testing using Condition of Use C conditions covers Condition of Use C through G and not C through H. Item 2 of Appendix II contains the advice found in the previous version of the guidance on the use of low density polyethylene (LDPE) in migration testing for a new adjuvant to cover use of the adjuvant in all polymers, but now contains additional advice on selection of appropriate polyolefins for testing the migration of a new adjuvant, reflecting input from the Committee. Finally, in Appendix IV, Table I ("Consumption Factors"), the new consumption factor for polyethylene terephthalate (PET) is now included, and the consumption factors for polystyrene are broken out further than they were in the previous guidance. With regard to the administrative guidance, the revised guidelines are substantially the same as the draft version, but there are several notable differences. First, the definition of the term "supplier" in Section II ("Scope of the FCN Program") now includes "any person supplying the [food-contact substance] FCS, including companies supplying the FCS to themselves for manufacture of a food contact material." Thus, FDA recognizes that a company may submit a notification as the "supplier" of a substance, even if it does not manufacture the substance. The administrative guidance clarifies that providing a comprehensive summary -- one of the required elements under 21 C.F.R. § 170.101 -- may be accomplished by the proper completion of FDA's Form 3480 (located in Section III ("Format of an FCN for an FCS")). Finally, the administrative guidance adds language regarding situations in which FDA believes any component of the notification under Section 170.101 is missing. FDA states that, in most cases, the notifier will be provided with a brief opportunity to supply the missing information. If the information is submitted in a timely manner, the 120-day review period begins on the date of receipt of the missing information. If the data is not submitted, FDA will issue a non-acceptance letter. Our experience indicates that, in practice, this refers to major items of missing information, not to FDA questions about details, which should not require "restarting the clock" if the answers can be provided quickly (within ten working days) and can be reviewed quickly by FDA (within one day). The toxicology guidance, entitled "Guidance for Industry (Final): Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations," can be found on the Agency's website at http://www.cfsan.fda.gov/~dms/opa2pmnt.html; the chemistry guidelines, entitled "Guidance for Industry (Final): Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations," can be found at http://www.cfsan.fda.gov/~dms/opa2pmnc.html. Finally, the administrative guidance, entitled "Guidance for Industry (Final): Preparation of Food Contact Notifications: Administrative," can be found on FDA's website at http://vm.cfsan.fda.gov/~dms/opa2pmna.html. 3. FDA Moves Toward Electronic Submissions FDA has issued a proposed rule that, when finalized, will be the first FDA regulation to require submission of information by electronic means. The rule, proposed on May 3, 2002, relates to labeling submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), and supplements. HHS Secretary Tommy Thompson says that this proposed rule is part of a larger initiative President Bush has ordered to use electronic data technologies to improve the federal government's efficiency. FDA has worked since 1997 to enable submission of information via electronic means, but previously has not required electronic submission. At this time, the Agency does not yet have the technology in place to allow the electronic submission of FCNs (although CD-ROMs may be submitted in addition to hard copies). FDA intends, however, that Form 3480 relating to FCNs eventually will form the basis for electronic submission. 4. President Bush Signs Farm Bill into Law Authorizing "Pasteurization" to Describe Food Irradiation On May 13, 2002, President Bush signed into law the Farm Bill that was passed by Congress earlier in the month. Despite strong opposition from consumer interest groups, the final version of the bill does contain a section allowing use of the term "pasteurization" for any treatment or process, including a series of treatments or controls, that achieves the same food safety effect as currently recognized pasteurization methods. This sets the stage for description of irradiated food as "pasteurized," which has been the goal of some companies interested in using irradiation to enhance food safety. As we have explained in previous letters, some in 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. The final version of the bill providing a definition of pasteurization to include methods other than traditional pasteurization processes differed in several respects from the previous version. Rather than amending Federal law generally, the final legislation specifically amends Section 403 of the Federal Food, Drug, and Cosmetic Act. The law also allows for the submission of premarket notifications to FDA to allow use of certain processes or treatments that have a food safety effect. The bill directs FDA to revise its irradiation labeling regulations. This is necessary because the regulations still require use of the descriptor "treated with radiation" and the radura symbol. 5. 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. 6. Lester Crawford Named FDA Deputy Commissioner; Player to be Named Later is Lead Candidate for FDA Commissioner 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 is now 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. Many people have been identified as the lead candidate for the FDA Commissioner during the Bush administration, but nobody has been nominated as of this writing. Dr. David Sundwall has been the person identified most recently as the "leading candidate." 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. 7. SPI Submits Comments to FDA on Use of Tamper-Evident Packaging for Food On March 11, 2002, this Committee 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 food security (67 Fed. Reg. 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. 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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