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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 December 5-6, 2002 Meeting Scottsdale, Arizona December, 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 June 27-28, 2002 meeting of the Committee. Table of Contents
1. Senate Confirms Dr. Mark McClellan as FDA Commissioner Dr. Mark McClellan, a White House health policy adviser for the President's Council of Economic Advisers, was approved by the Senate in an October 17, 2002, voice vote to be the next Food and Drug Administration (FDA) Commissioner. Previously, the Senate Committee on Health, Education, and Labor & Pensions had voted unanimously to approve the confirmation of McClellan as the new FDA Commissioner, a post that has been empty since former Commissioner Dr. Jane Henney resigned in January 2001. McClellan testified October 7, 2002 before the Senate Committee on Health, Education, and Labor & Pensions and fielded questions from Committee members on food safety and health care. Committee Chair Sen. Edward Kennedy (D-MA) showed unconditional support for McClellan and stated, "Dr. McClellan has the training, the experience and the stature to serve as the head of the country's most important public health regulatory agency." Before the Senate vote, Health and Human Services (HHS) Secretary Tommy Thompson released a statement stating that Dr. McClellan is a superb choice for FDA Commissioner because he could bring informed analysis and scientific knowledge combined with strong, compassionate leadership to important public policy decisions. Dr. McClellan has no visible ties to the drug industry, which may have expedited his confirmation by the Senate. He was confirmed by the Senate for the position on the Council of Economic Advisers, and he held a position as deputy assistant secretary of the Treasury for economic policy during the Clinton administration. Mark McClellan's masters degree in regulatory policy and his medical degree are from Harvard University, and his doctorate in economics is from the Massachusetts Institute of Technology. He has served as a member of the National Cancer Policy Board of the National Academy of Sciences and as a professor of economics and medicine at Stanford University. 2. FDA's October 15, 2002 Stakeholders' Workshop on Food-Contact Notification (FCN) Process On October 15, 2002, FDA held an open workshop on the FCN program. The purpose of the workshop was to highlight some of the ways in which notifiers can help make the FCN process more efficient, as well as entertain industry comments and suggestions to assist FDA in improving the program. On behalf of this Committee, Keller and Heckman LLP submitted several questions and suggestions to FDA for discussion at the meeting. In addition, the Committee was represented at the meeting by Susan Howe, the Committee's staff director; Jerome Heckman, Ralph Simmons, and Les Borodinsky of Keller and Heckman; and several members of the Committee. Dr. Mitchell Cheeseman, Director of FDA's Division of Food Contact Substance Notification Review, Office of Food Additive Safety, urged attendees to "tell a complete story" with their FCN submissions. "Complete information helps us to help you," he stressed. Because the process is slowed considerably when reviewers must request additional information, providing complete information at the outset will benefit all parties. Dr. Cheeseman added that, while the Agency wants notifiers to assess the safety of all migrants, exhaustive treatment is not always necessary. "Often a brief, reasonable explanation of why something is not likely to migrate is all we're looking for." In the end, Dr. Cheeseman said, the Agency's goals are to help industry to comply with the law, to enhance consumer confidence, to assure public health, and to make it easier to bring innovative products to the marketplace. Administrative Concerns According to Dr. Anna Shanklin, a Consumer Safety Officer (CSO) for the Division of Food Contact Substance Notification Review, the Agency has received, as of October 7, 2002, a total of 291 FCNs. Of that number, Dr. Shanklin indicated that 206 are now effective. In addition, 48 were withdrawn after phase-I review; three were withdrawn after phase-II review; one was not accepted; and 36 are currently under review. These numbers actually add up to 294, so the exact number of total FCNs received so far is a little unclear. Dr. Shanklin explained the standard procedure the Division follows when it receives an FCN. Upon receipt by the notification control assistant, the receipt date is logged and the 120-day effective date is set. The notification is then sent to the individuals who will review its toxicology, chemistry, and environmental aspects, and to the CSO. Those individuals will then hold a phase-I review meeting, ideally within three weeks, to determine whether the Agency will accept the notification. If the notification is accepted, the notifier will be sent an acknowledgment letter, and the notification will move to phase-II review. If the notification is not accepted, the notifier receives a deficiency letter, and can then opt either to withdraw the notification or respond to the deficiency within 10 business days. If the response is acceptable, the notification moves to phase-II review-but if the deficiency is of the type that "hinders the review process," the 120-day clock will not start until the Agency receives the information that rectifies the deficiency. Keller and Heckman noted that FDA has stated its intent to determine whether an FCN is complete and reviewable within 30 days of receipt, and to send an acknowledgment letter to that effect. However, the firm has received acknowledgment letters anywhere from 90 days after submission to a few days before the FCN was due to become effective, leaving the notifier uncertain as to when the notification will become effective. Dr. Cheeseman recognized that acknowledgment letters are sometimes late, and asked to be informed of the specific circumstances when this happens. Keller and Heckman also pointed out that FDA has been inconsistent in setting deadlines for notifiers to respond to Agency requests for information. Some CSOs have set deadlines as short as two days, based on their assumption that the information should be easy to obtain. However, notifiers often have difficulty obtaining information, particularly where data is required from third parties, such as suppliers and laboratories, and where parties are located outside the U.S. The firm also pointed out that a significant portion of the response time can be lost while a deficiency notice is in the mail, and requested that it be made a policy for the Agency to send requests for additional information by fax or email. Dr. Cheeseman agreed that the 10-day response time should be incorporated into the Administrative Guidance. "I believe that we can make the change, and I'll say so today," he remarked. Confidentiality Issues Typically, FCNs contain confidential trade secret information that, under 21 C.F.R. § 20.61(c), is exempt from disclosure to the public under the Freedom of Information Act (FOIA). Thus, notifiers often mark trade secret information as "confidential" in FCN submissions, and provide a "sanitized" version of the FCN to assist the Agency in responding to any FOIA requests it may receive. Keller and Heckman partner Ralph Simmons pointed out that FDA has, on occasion, taken issue with a claim of confidentiality and has disclosed information marked by the notifier as "confidential." It is Keller and Heckman's position that, if FDA determines that any information identified as confidential nevertheless should be disclosed in response to a FOIA request for an effective FCN, the Agency should contact the notifier before releasing the information and allow the notifier time to respond as provided by 21 C.F.R. § 20.61(e). According to Simmons, the Agency's failure to make contact with a notifier before information was made public has, in fact, resulted in the release of confidential information. Drs. Shanklin and Cheeseman responded that FDA is not bound to provide notice if the Agency determines that information claimed as confidential is, in fact, not confidential. The Agency is relying on an exception to the procedure where there is a specific regulation describing the disclosability of information. "We're not required to discuss that in advance," Dr. Shanklin said. "However, if we think there is likely information in a gray area, we'll seek to discuss it." Efficacy Debate Dr. Kirk Arvidson of the Division of Food Contact Substance Notification Review provided an overview of the Agency's chemistry recommendations. According to Arvidson, a notification should include information about the identity of the food-contact substance and its composition; a description of the use and the typical and maximum use level of the substance; data to support that the substance achieves the intended technical effect and that the use level is the minimum amount of the substance needed to achieve the technical effect; migration testing and analytical methods; and consumer exposure to the substance. Keller and Heckman partner Jerome Heckman took issue with Arvidson's assertion that the Agency has the authority to require efficacy data beyond a statement of intended conditions of use, referencing an analysis he recently authored on the topic (see the article, "U.S. Agencies Lack Authority to Question Efficacy of Food Additives, Yet Questions Continue to Be Raised," on Keller and Heckman's website at www.packaginglaw.com). The FDA, Heckman remarked, has never been granted the statutory authority to demand proof of efficacy or that some defined amount of a substance is required to accomplish an intended purpose. [Section 309 of the Act says that, if a tolerance is required with respect to an additive, something that is almost never the case, a Petitioner must indicate what amount is the least that can be used to accomplish the intended purpose.] Otherwise, he said, FDA cannot require data on whether food additives are effective, and cannot make any determination about an additive based on efficacy considerations. Further, the legislative history of the governing statutes makes it clear that requesting efficacy data on food additives is inappropriate. Heckman acknowledged that the Agency is entitled to information as to the intended use of food-contact substances to aid in the evaluation of its safety, and can deny a notification if it makes a finding that a substance will work a deception on consumers, but that is the limit of the Agency's authority. "It is time for FDA to stop perpetuating the myth that petitioners or notifiers must prove that use of a substance will be efficacious," he remarked. "Requiring efficacy data is neither necessary nor proper; FDA must rule on safety, but the marketplace will decide on efficacy since no one will go to the expense of using a substance in packaging that accomplishes no purpose." 3. SPI and APC Submit Separate Comments to FDA on Licensing of FCN Rights On August 5, 2002, Keller and Heckman LLP submitted comments on behalf of this Committee to FDA in response to the Agency's request for input on whether to establish a procedure by which holders of the rights to manufacture and market a food-contact substance that is the subject of an effective FCN would be able to transfer those rights by sale, licensing, or otherwise. As you may recall, the Advance Notice of Proposed Rulemaking (ANPR) published in a May 21, 2002 Federal Register notice (67 Fed. Reg. 35764) sought comments on this issue. FDA's request for comments stemmed from a submission it received from the American Plastics Council (APC), in response to the Agency's earlier request for comments on the July 2000 proposed rule on implementation of the FDA Modernization Act's FCN provisions. Because FDA deemed APC's comment to be outside the scope of the proposed rules on the FCN program, the Agency declined to address it in the final rule, and instead issued the ANPR. Although FDA issued the ANPR in response to APC's suggestion, APC filed separate comments agreeing with SPI that there is "no significant benefit to be gained by implementing a procedure to transfer or license the rights to a FCN." Specifically, in our comments to the Agency, we expressed SPI's view that the relatively rapid clearance of food-contact substances through the FCN mechanism significantly reduces the potential value of a right to transfer the clearance. We noted that any company can bring about an effective FCN in 120 days and that much of the data underlying an effective FCN can be obtained by other companies through a FOIA request. For these reasons, we advised FDA that there is no significant benefit to be gained by adding a procedure to transfer the rights acquired by an FCN. If FDA nevertheless decides to create such a procedure, we recommended that it should involve only a simple notification to the Agency that the transfer has occurred. SPI also requested FDA to provide guidance on the procedure to amend the name of the manufacturer/supplier in the event of a corporate name change or change in ownership or control. FDA has indicated in its administrative guidance document on the FCN process that the Agency would confirm the procedure for changing the name of a manufacturer/supplier, but this guidance has not yet been provided. 4. SPI Participates in Bioterrorism Act Implementation Coalition - Recordkeeping Working Group Susan Howe has been working with several industry groups on establishing an industry consensus with respect to FDA's implementation of the Bioterrorism Preparedness Act's recordkeeping requirements. (The bioterrorism bill was signed into law by President Bush on June 12, 2002.) Specifically, the Recordkeeping Working Group has been discussing issues associated with the new Section 414(b) of the Federal Food, Drug, and Cosmetic Act ("Regulations Concerning Recordkeeping"). The information called for in Section 414(b) is intended in general to provide the Agency with the means of determining who had custody of the affected food or its packaging throughout the channels of trade. The Working Group has agreed, in accordance with our understanding of the intent of Congress, that the recordkeeping requirement regarding immediate suppliers and customers does not apply to packaging suppliers. Companies engaged in packaging food, however, will be called upon to maintain records identifying the supplier of the packaging. These positions will be advanced in discussions with FDA regarding the promulgation of regulations to implement the recordkeeping provisions of the Bioterrorism Act. FDA plans to publish proposed regulations by the end of this year and a final rule by December 12, 2003. 5. FDA Releases Draft Guidance Document on Medical Devices Made with PVC Using DEHP On September 6, 2002, FDA released a draft guidance document titled, "Medical Devices Made with Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP);" the document can be accessed on FDA's website at www.fda.gov/cdrh/ode/guidance/1407.html. In the document, FDA offers suggestions on ways to reduce or eliminate risks that may be associated with DEHP, such as by labeling certain devices with their DEHP content or eliminating DEHP in certain devices that may result in high aggregate exposures in sensitive patient populations. While FDA confirms that there are no human studies that show the toxic and carcinogenic effects of DEHP that have been demonstrated in laboratory animals, FDA is concerned with the small subset of medical devices where PVC-containing DEHP may come into contact with the tissue of a sensitive patient population for a period of time that may raise concerns regarding aggregate exposure to DEHP. FDA cites devices used in Neonatal Intensive Care Units (NICU) as one example. FDA recommends considering the feasibility of replacing PVC-containing DEHP with either alternative materials or plasticizers, or using coatings that may minimize patient exposure to DEHP. In addition, FDA suggests labeling devices to indicate the presence of DEHP. While FDA "believes there is insufficient information to justify requiring device manufacturers to disclose the presence of this chemical in the device's labeling," the Agency states that there is considerable interest among consumers in mitigating risks that exposure to DEHP may involve. 6. FDA's Draft Action Plan and Public Meeting on Assessing Acrylamide in Food FDA presented its draft action plan for assessing acrylamide in food at a public meeting on September 30, 2002; the plan is available on FDA's website at www.cfsan.fda.gov/~dms/acryplan.html. The plan outlines FDA's goals and planned actions regarding acrylamide, which the Swedish National Food Administration discovered in a variety of fried and oven-baked foods. By way of background, the Swedish research indicated that acrylamide formation is associated with high temperature cooking of certain foods, and these findings have been confirmed by Norway, the United Kingdom (UK), Switzerland, and the U.S. Acrylamide is a potential human carcinogen, neurotoxicant, and genotoxicant, but its actual impact on public health is unknown. While FDA announced that it has confirmed the presence of acrylamide in foods, it noted that the amount of the potential carcinogen varies widely within a given food category, depending on how specific brands of foods are processed. Agency officials indicate that further testing of different kinds of foods, the mechanisms by which acrylamide is formed, and the toxicological effects of acrylamide is needed before the Agency makes any public recommendations about dietary changes. FDA is continuing to test different food samples to gain additional insight at this time. At FDA's September 30, 2002 public meeting, Terry Troxell, Ph.D., FDA, discussed FDA's overall goal for assessing acrylamide in the food supply through scientific investigation and risk management decision making, and prevention and/or reduction of the potential risk of acrylamide in foods to the greatest extent feasible. More recent research indicates that asparagine, an amino acid naturally occurring in many fruits and vegetables, leads to the formation of acrylamide when heated with certain sugars, such as glucose. Further research in this area is continuing. A survey by the UK Food Standards Agency, however, concluded that it is very unlikely that paper and paperboard packaging is a source of acrylamide. 7. FDA Issues Guidance Document Regarding Labeling for Irradiated Foods In October 2002, FDA issued a guidance document, "Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by Irradiation." The document is available on FDA's website at www.cfsan.fda.gov/~dms/irraguid.html. FDA issued this guidance to interested parties who wish to petition the Agency for approval of labeling for a food that has been treated by irradiation. The Farm Security and Investment Act requires that FDA revise current regulations governing the labeling of irradiated foods and further requires that, until the Agency issues the rule, it must consider a firm's petition for alternative labeling of irradiated foods that is "truthful and not misleading." FDA then has six months to approve or deny the petition and, if no decision is made, the petition is deemed denied. The Agency's guidance indicates that food firms wanting to gain Agency support for alternative labeling on irradiated foods must submit consumer research showing that consumers understand the intent of the proposed labeling. Public Citizen, a long-time opponent of food industry attempts to replace current irradiation labeling with new terms such as "cold pasteurization," reportedly is pleased with this requirement, since it believes that consumer research indicates that consumers think alternative names for irradiation are misleading. 8. National Toxicology Program (NTP) Issues Expert Panel Report on Endocrine Disruptor Screening A report detailing the current status of testing to detect endocrine disrupting effects -- along with a list of substances proposed for the validation of in vitro endocrine disruptor screening methods -- has been issued by NTP in the Public Health Service of the U.S. Department of Health and Human Services. By way of background, in 1996, Congress directed the U.S. Environmental Protection Agency (EPA) to develop a screening program to evaluate the hormone-related health effects of pesticides and other substances. EPA's Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) responded with a recommendation that a screening and testing program be implemented for identifying endocrine disruptors. EPA then proposed the Endocrine Disruptor Screening Program, consisting of "Tier 1" screening tests designed to identify substances capable of interacting with the endocrine system, and "Tier 2" testing assays designed to confirm and extend the Tier 1 results. The Tier 1 in vitro assays include estrogen receptor (ER) and androgen receptor (AR) assays, including either binding assays or transcriptional activation (TA) assays. NTP's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), which supports the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM), assessed the current validation status of the in vitro test methods, preparing background review documents (BRDs) on in vitro ER and AR binding assays and TR assays. As part of its evaluation, the agency asked for development of minimum performance criteria to define acceptable assays. After an extensive literature search, NICEATM and ICCVAM determined that no validation studies have been completed on the assays being considered. Accordingly, they decided to convene an expert panel to evaluate the current status of the assays and the development of recommendations for their future validation. At a meeting in May, the expert panel was charged with developing recommendations on the four types of in vitro endocrine disruptor screening methods. In an October 22, 2002 Federal Register notice (67 Fed. Reg. 64902), NTP announced the availability of an "Expert Panel Report on the Current Validation Status of In Vitro Endocrine Disruptor Screening Methods and a Proposed List of Substances for Validation of In Vitro Endocrine Disruptor Screening Methods." The expert panel report is available at iccvam.niehs.nih.gov. Several of the chemicals slated for inclusion in the validation study might be of interest to packaging materials manufacturers, including bisphenol A, nonylphenol, octylphenol, cumylphenol, butylbenzyl phthalate, dibutyl phthalate, and diethylhexyl phthalate (DEHP). 9. European Commission (EC) Issues Directive 2002/72/EC ("Plastics Directive") - A Consolidation of the "Monomers Directive" and its First 7 Amendments The EC has adopted a consolidated version of the so-called "Monomers Directive" (90/128/EEC) and all of its existing amendments (1st Amendment - 7th Amendment). This Directive, 2002/72/EC (also known as the "Plastics Directive"), relating to plastic materials and articles intended to come into contact with foodstuffs, repeals and replaces Directive 90/128/EEC and all of its amendments. (Since this Directive relates to both monomers and additives for food-contact articles that are made entirely of plastic, we have been advised that it is considered more appropriate in the EU to refer to the Directive as the "Plastics Directive" rather than the "Monomers Directive.") The consolidated Plastics Directive became effective on September 5, 2002. Article 10(1) of Directive 2002/72/EC confirms that this date will not affect the provisions included in the 5th, 6th, and 7th Amendments for which the deadlines for Member States' implementation measures have not yet elapsed. None of the proposed modifications included in the draft 8th Amendment to Directive 90/128/EEC is included, since this Amendment has not yet been adopted. If and when adopted, the so-called "8th Amendment" is likely to become the "1st Amendment" to Directive 2002/72/EC. 10. EC Circulates Draft 1st Amendment to Plastics Directive The EC has circulated to industry and to Member State contacts a draft proposal for a first amendment to Commission Directive 2002/72/EC, the "Plastics Directive," discussed above. The 1st amendment to the Plastics Directive follows along the lines of the previously circulated draft 8th amendment to the Monomers Directive, albeit with some important modifications. Specifically, the draft amendment proposes the following changes to the Directive:
Given the continued complexity involved in completing and maintaining the "positive list" system for plastic monomers and additives in the EU and the delays inherent in the current system (as illustrated by the proposed amendment), perhaps the time has come for the introduction of a notification system into EU legislation. 11. Revision of the EU Packaging and Packaging Waste Directive Directive 94/62/EC on packaging and packaging waste is in the process of being reviewed by the EC. The process began when the EC presented a December 7, 2001 proposal for the amendment of Directive 94/62/EC containing the following main points:
The Commission's proposal is now in the process of being reviewed by the European Parliament (EP) and the Council of Ministers. The changes made by the EP during its first reading (on September 3, 2002) include the following:
This is, however, far from being the last stage in the adoption of the amendments, as the Commission's proposal will now be reviewed by the Council of Ministers, and will go back to the EP in case the Council proposes further amendments (in line with the "co-decision" legislative procedure). The entry into force of the final measures is not expected prior to the end of 2003. 12. Germany Shutters BgVV; Assigns Duties to Other Agencies In an effort to establish a clear delineation between risk assessment and risk management, Germany has restructured its consumer health and food safety functions, dissolving in the process its Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV). The food-related responsibilities of the BgVV have been assumed by two federal institutions: the Federal Agency for Consumer Protection and Food Safety (BVL), and the Federal Institute for Risk Assessment (BfR). October 31, 2002 was the last working day for the eight-year-old BgVV. Established in 1994 as a successor institution to the Federal Health Office, the BgVV played a role in a variety of health-related issues: dioxins; Bovine Spongiform Encephalopathy (BSE); food-borne pathogens; and antibiotic resistance. Sources at the BgVV report that the Plastic Commission, which works on the "BgVV Recommendations," will be managed under the BVL. The BgVV Recommendations are widely respected and relied upon throughout Europe as a source of guidance for establishing the safety and suitability of food-packaging materials. While many details still need to be worked out, it appears that the way in which the group operates should basically remain the same, and the petition process for bringing about listings in the Recommendations should remain the same. 13. Food Standards Australia New Zealand (FSANZ) Has Replaced the Australia New Zealand Food Authority (ANZFA) Australia regulates food packaging materials under the Australian Food Standards Code (the Code), a binding code issued by the National Health and Medical Research Council. Established under The Australia New Zealand Food Authority Act of 1991, the Food Standards Australia New Zealand (FSANZ) (which replaced the Australian New Zealand Food Authority (ANZFA) on July 1, 2002), in consultation with the States and Territories of Australia, is responsible for developing food standards under the Code, and for coordinating the food surveillance activities of government agencies in Australia. FSANZ, however, does not enforce food standards or determine whether or not a food, food label, or food packaging material complies with the Code; rather, enforcement of the Code and any related standards is the responsibility of the respective States and Territories because the Code and all subsequent standards are incorporated by reference directly into the laws of the States and Territories of Australia and New Zealand. While the Code does not contain a specific standard applicable to food packaging, Standard A13 of the Code, "Foreign Objects in Food or Packages of Food," indicates that food packaging materials must not adulterate food, and specifically addresses the following items: (1) ink on printed food-contact packages; (2) labels applied directly to foods; (3) cooking gauges inserted into meat; and (4) sachets used to absorb moisture in food packages. In addition, this section indicates that substances are permitted for use in food packaging applications if, among other things, they are "composed of materials that will not contaminate or migrate into the food." Furthermore, for any food packaging material not listed above, it is generally recognized that food packaging materials that comply with U.S. and EU regulations are permitted for use in packaging food in Australia, so long as the materials do not adulterate food. As noted above, FSANZ replaced the ANZFA on July 1, 2002. FSANZ now has authority over the entire food supply chain, including setting new mandatory safety standards for the food manufacturing industry and equivalent standards for primary producers (i.e., farmers or fishermen). The new ANZ Food Regulation Ministerial Council (previously the ANZ Food Standards Council) has assumed the ANZFA board's policymaking role. FSANZ is itself responsible for approving standards and variations to standards, which differs from ANZFA's previous role in only recommending new food standards to the Food Standards Council for approval or rejection. When reviewing future food standards, FSANZ will follow ministerial guidelines and notify the ministerial council of any approval. The council may then reject, amend, or seek a review of any standard notified to it by FSANZ. Former Victorian Health Minister Rob Knowles has been appointed the chairperson of the inaugural FSANZ Board. 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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