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 May 10, 2001
(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 discuss the Food and Drug Administration's (FDA) intent to overhaul the organization of its Office of Premarket Approval, the Secretary of Health and Human Services' (HHS) search for a new FDA Commissioner, and legislation that proposes a single food safety agency. We also discuss HHS's plan to review any burdensome regulations passed by the Clinton administration and continuing issues surrounding the irradiation of food, including FDA's movement toward irradiation testing protocols. Finally, we report on various recycling initiatives sought by federal and state legislators and the European Union's (EU) proposal to establish a European Food Authority.
Table of Contents
1. FDA Contemplates Organizational Changes We understand that FDA is finalizing a plan to overhaul the organization of its Office of Premarket Approval (OPA). The Agency's apparent intent in undertaking the overhaul is to increase the efficiency of the review process for food-contact materials and direct food additives. According to FDA sources, a new Office of Food Additive Safety (OFAS) is planned to replace the 10-year-old OPA. It appears, however, that the new office will be staffed by many of the same FDA personnel currently working in OPA. The OFAS will be made up of three operational divisions that report to the Office of the Director: the Division of Food Contact Substance Notification, the Division of Petition Review, and the Division of Biotech & GRAS Notice Review. The reorganization contemplates scuttling the Division of Health Effects Evaluation, which in the past had been responsible for performing toxicological evaluations. Instead, that function has been distributed among the three operational divisions; each will have its own subdivisions for chemistry, toxicology, and regulatory matters. In addition to the three operational divisions, the OFAS will have a policy-making division under the Office of the Associate Director for Science and Policy. In the past, the policy-making function was handled in a less formal manner by a policy board made up of the division directors and the technical experts necessary to resolve a specific problem. The proposed reorganization also includes a Division of Chemistry Research and Environmental Review and an operational support division. The organizational changes are reportedly being reviewed by the National Treasury Employees Union, which represents FDA employees. Implementation of the changes also will require publication in the Federal Register and placement in the Code of Federal Regulations, at 21 C.F.R. § 5.200. 2. HHS Secretary Says Naming FDA Commissioner a High Priority, also Announces Plans to Review Burdensome Regulations Responding to rumors that it may take up to a year to name a new FDA Commissioner, Health and Human Services (HHS) Secretary Tommy Thompson announced that he hopes to name the new commissioner as soon as possible. The last time it took two years to name a new commissioner, and sources say that the Bush Administration does not want that much time to go by this go-around. Sources also say that one candidate has been through the first round of interviews. Numerous names are being floated as potentials for the position, but Michael Friedman is rumored to be the top runner. Friedman held various positions at FDA in the late 1990s, including acting commissioner in 1997 and 1998. He currently is vice president in research and development at Pharmacia Corp. Thompson also plans to make changes to how the Agency is run, with an eye for easing the regulatory process. At a recent summit on privacy regulation in Washington, D.C., Thompson announced his plans to review all health care regulations and dispense with those he considers overly burdensome. He also is seeking industry's help in identifying those regulations, and the National Food Processors Association (NFPA) already has recommended changes to several regulations. Among the first things NFPA would like Thompson to strike down are food irradiation labeling requirements. Such a move would likely meet serious opposition from Public Citizen, which, as we have reported previously, strongly supports strict labeling requirements for irradiated foods. 3. Democratic Lawmaker to Propose Single Food Safety Agency Despite previous failed efforts, there continues to be a movement on Capitol Hill toward establishing a single food safety agency. On May 1, 2001, Rep. Rosa DeLauro (D-Conn.) introduced legislation to propose such an agency. The proposed Safe Food Act of 2001, H.R. 1671, would provide for a new Food Safety Administration (FSA) that would handle the food safety, labeling and inspection functions now being handled by FDA, the U.S. Department of Agriculture, and other agencies. Rep. DeLauro unsuccessfully introduced a similar measure in 1999. Many consumer groups, such as the Center for Science in the Public Interest and Safe Tables Our Priority, have endorsed similar proposals. However, industry groups have expressed opposition to a single food safety agency. Among their complaints are fears that a single food safety agency would merely become a "super-bureaucracy" which would need to justify its existence by excessive regulation. As alternatives to consolidating the current system, industry groups in the past have recommended additional research and educational efforts, improved food safety technology, increased inter-agency coordination of food safety activities, and stronger federal leadership. 4. FDA's Movement Toward Irradiation Testing Protocols Raises Concerns A recommended protocol for irradiation testing has been provided by the U.S. Food and Drug Administration to certain companies currently seeking FDA clearance of packaging materials for the irradiation of food. Our review of the protocol has identified some significant questions. To date, there has been no published guidance from FDA concerning the conduct of the requisite studies to establish the safety of packaging materials to contain food during irradiation. However, following discussions on the appropriate testing of particular materials for irradiation, FDA recently provided us with a document titled "Testing Protocols for Determining Exposure to Radiolysis Products from Packaging Materials Irradiated in Contact with Food." While the document has not yet been cleared by FDA for general release, the Agency is expected ultimately to issue formal guidance on irradiation testing. FDA permits certain types of irradiation as a means to treat specified foods for the purpose of controlling microbes, pathogens, pests, and the maturation of food. Regulations governing the irradiation of food are found in Title 21 of the Code of Federal Regulations, Part 179, "Irradiation in the Production, Processing and Handling of Food." Section 179.45 specifies materials that have been cleared by FDA specifically to package food intended to be irradiated. Because few food packaging materials are listed in Section 179.45, a number of companies are attempting to win FDA clearance of additional materials. To that end, appropriate studies must be conducted to demonstrate the potential for formation and migration of radiolytic byproducts from the packaging materials to the food. Generally, a company will first determine if radiolytic byproducts are formed as a result of the irradiation process and, if so, it will determine whether these byproducts migrate to food at levels that are considered to be safe. It should be noted that, in our view, all packaging materials do not need to be listed in Section 179.45 to have a suitable FDA status for holding food during irradiation. If a material has FDA compliance for contact with food generally, we consider it suitable to hold food for irradiation if it can be demonstrated that no significant change in the potential migrants is caused by irradiation. Of course, testing usually is required to support such a conclusion, and appropriate FDA guidance would be helpful to companies in conducting the proper tests. The draft document details two different protocols, either of which can be used: a "step-wise" approach, and a "direct migration" approach. The "step-wise" approach involves irradiation of the packaging material using a range of doses to determine the dose/response curve for the formation of the various radiolytic byproducts, if any. Once byproducts are identified and their levels in the packaging are determined, it is assumed that 100 percent of the byproducts will migrate into the contacted food. If the calculated level of any byproducts in the food is too high to evaluate without additional toxicity studies -- 0.5 parts per billion (ppb) in the diet -- migration studies must be carried out on the irradiated packaging to determine the actual level of the byproducts in the contacted food. Again, the dietary level for any migrating byproducts must be below 0.5 ppb if toxicity testing is to be avoided. A level higher than 0.5 ppb, of course, triggers the usual prescribed series of toxicology studies to demonstrate the safety of the packaging materials under these conditions of use. Also included in the "step-wise" approach is the requirement to carry out the same studies on a "check sample," which is a standard reference polymer obtained from the National Institute for Standards and Technology (NIST). The results obtained on the standard reference polymer by the company will be compared to the results obtained by FDA on the same standard reference polymer, as a way of verifying that the irradiation studies were carried out correctly. The "direct migration" approach essentially goes directly to the migration studies, after a quick screen to identify any low-molecular-weight radiolytic byproducts. This approach does not require the use of a "check sample." Rather, validation of the testing is done with the use of spiked "surrogate" chemicals to represent any byproducts found to migrate into contacted food. Using either of FDA's two draft recommended testing protocols will involve a substantial amount of work that is very costly -- in terms of both time and money -- to conduct. We intend to provide comments and suggestions on the draft test procedures before they are finalized in the form of a guidance document. 5. FDA Considers Combining Clearance of Irradiation Petitions During an industry-sponsored conference on Food Irradiation, FDA's George Pauli said that FDA is considering combining into a single clearance three petitions that would allow the irradiation of several multi-ingredient and meat products. The regulation could cover the irradiation of multi-ingredient products, non-refrigerated meat food products, and amendments to FDA's current poultry provision. Pauli, director of the Division of Product Policy at FDA's Office of Premarket Approval, pointed out that the multi-ingredient petition, often referred to as the "ready-to-eat" petition, covers foods such as cooked poultry products, refrigerated and frozen entrees, frozen sandwiches, and some prepared fruits and vegetables. With regard to the other two petitions FDA is considering including in the single regulation, one would allow irradiation of non-refrigerated meat food products and the other would amend the current poultry regulation to raise the maximum allowable dose and remove packaging limitations. Action on the "ready-to-eat" petition has been rumored to be imminent for several months now. 6. Companies Prepared to Begin Irradiating Food on a Mass Scale Once FDA Provides Clearance; Public Citizen Continues its Assault on Irradiation Despite the fact that Public Citizen continues to urge FDA to reject petitions involving the irradiation of food, representatives from companies that have developed x-ray, e-beam and gamma irradiation say that they are ready to begin servicing the food industry on a mass scale once FDA approves broader use of the technology. Approval of the ready-to-eat petition in particular would widely broaden the scope of foods allowed to be irradiated. Recently, Public Citizen has called upon FDA to conduct toxicological tests on the foods that are subjects of the ready-to-eat petition. The group has often voiced its concern that FDA has approved petitions involving irradiation of foods without conducting toxicological tests. Now, a New Jersey official, Assemblyman John Kelly, is joining with Public Citizen and other consumer advocacy groups to voice these concerns. An aide to Kelly announced that he plans to issue a report in the next few weeks alleging that FDA has failed to adequately review toxicological information relating to petitions involving irradiation of foods. Last year Rep. Kelly introduced a bill that would ban the sale and distribution of irradiated food in New Jersey. The bill is expected to be approved by the state Assembly this spring, but its prospects in the state Senate appear less favorable. 7. Codex Committee Approves Removing Irradiation Dose Cap During its March 12 - 16, 2001 meeting, the Codex Alimentarius Committee on Food Additives and Contaminants approved a proposal to remove the current 10 kiloGray dose cap for food irradiation. The full Codex Commission will consider adopting the proposal during its biennial meeting in July. As expected, Public Citizen immediately opposed the proposal, arguing that chemical changes to food caused by high-dose irradiation have not been adequately studied. 8. Various Recycling Initiatives Sought by Federal and State Legislators Rep. Lynn Rivers (D-Mich) has introduced a bill that would establish the country's first national beverage container recycling program. The bill, entitled the national Beverage Container Reuse and Recycling Act of 2001, would amend the Solid Waste Disposal Act to provide consumers with a 10-cent refund for the return of empty, unbroken containers. It would apply to a wide variety of beverage containers, including metal, glass, and plastic ones that have a capacity of up to one gallon, that hold wine coolers, sparkling or carbonated water, fruit juice, beer, soft drinks, and other beverages. The bill seems certain to attract strong opposition from the food industry. On the state level, a bill has been introduced in California that would require a plastic pollution prevention fee to be paid by companies packaging products in plastic containers if a 50% statewide plastics recycling rate is not attained by January 1, 2005. The fee would be equal to the difference between the scrap value and the cost of recycling for each resin type, except as specified. Currently, California's plastics recycling law requires a 25% statewide recycling rate, but food and beverage containers are exempt. The new bill does not contain an exemption for food and beverage containers. It is sponsored by state Senator Wesley Chesbro, who has previously proposed toughening California's existing plastics recycling law, including ending the exemption for food and beverage containers. Efforts also continued in Hawaii to pass deposit legislation during the spring session. Companion bills were introduced in both the House and the Senate. However, the bill did not make it out of Committee before the Hawaii legislature adjourned earlier this month. In Iowa there is talk of expanding the current deposit system beyond the current soft drink and beer to include other beverages such as water. In the past, these proposals have not gone very far. We are monitoring these situations and will continue to update the Committee on any developments. 9. EU Publishes Final Proposal to Establish European Food Authority A final proposal to establish a European Food Authority -- and to lay down the general principles and requirements of food law -- was made public March 27 with publication in the Official Journal of the European Commission. In a preamble to the document, the European Parliament and the Council of the European Union expressly adopt a broad definition of food law -- covering a wide range of provisions, including provisions on materials and articles in contact with food -- "[i]n order to take a sufficiently comprehensive and integrated approach to food safety." The proposal states that the free movement of food within the European Community "can be achieved only if food safety requirements do not differ significantly from Member State to Member State." The adoption by individual Member States of measures governing food can give rise to differences that "may impede the free movement of food, create unequal conditions of competition, and may thereby directly affect the functioning of the internal market," the proposal states. The proposal further states that "[e]xperience has shown that it is necessary to adopt measures aimed at guaranteeing that only safe food is placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the proper functioning of the internal market and to protect human health." Risk-based approach The proposal asserts that measures governing food safety must be based on three interconnected principles of risk analysis: risk assessment, risk management, and risk communication. Risk assessments, it states, "should be undertaken in an independent, objective and transparent manner, on the basis of the available scientific information and data." However, where scientific risk assessment alone is insufficient, other relevant factors -- including societal, economic, ethical, and environmental factors -- can be taken into account. The proposal acknowledges that the precautionary principle has given rise to barriers to the free movement of food. However, it advocates the use of the principle because it provides a mechanism for determining risk management measures or other actions to ensure a high level of health protection. Broad role for Authority The proposal also advocates the establishment of a European Food Authority to reinforce the present system of scientific and technical support. The Authority's function would be to serve as a mechanism for applying the general principles of food law and would further take on the role of an independent scientific point of reference that can be called upon to give opinions on contentious scientific issues. The Authority is to be governed by a management board, which will include four representatives appointed by the European Parliament, four by the Council, and four by the Commission. In addition, four representatives of consumers and industry will take seats on the board. The board will establish and implement a budget, adopt financial regulations, appoint scientists, and select an executive director. Finally, the Authority will take a lead role in establishing measures during food safety emergencies, to ensure "that all foods, whatever their type and origin, [are] subject to common measures in the event of a serious risk to human health." Recent crises, the proposal states, have shown the benefit of having rapid procedures for crisis management. Scientific scheme The proposal also stipulates that the Authority will assume the role of the scientific committees attached to the Commission in issuing scientific opinions, although the committees will be reorganized to ensure greater scientific consistency. To that end, the proposal recommends the establishment of a scientific committee and eight permanent scientific panels within the Authority, the members of which should be "independent" scientists. The scientific committee -- which will consist of the chairperson of each scientific panel and six independent scientific experts that do not belong to any of the scientific panels -- will be responsible for the consistency of the scientific opinion procedure and will provide opinions on multisectoral issues that do not fall within the competence of any scientific panels. The permanent scientific panels will replace the existing scientific committees that deal with food, including the Standing Committee for Foodstuffs, the Standing Veterinary Committee, the Standing Committee for Feeding stuffs, and the Standing Committee on Plant Health. The new panels, which will divide the existing workload into smaller areas of interest, will be: food additives, flavors, processing aids and materials in contact with food; additives or substances used in animal feed; plant protection products and their residues; genetically modified organisms; dietetic products, nutrition and allergies; biological hazards; contaminants in food; and animal health and welfare. The panels will issue scientific opinions at the request of the Commission, the European Parliament, or on their own initiative, within the scope of the directive. They will also, at the request of the Commission, provide scientific and technical assistance in preparation of guidelines and guides to good practices. In addition, they will collect data on food consumption and exposure of individuals to residues to assist in evaluation of risk. The proposal also puts the panels in charge of the existing Rapid Alert System developed to warn Member States of impending problems with food or feed. They are charged with the task of expanding this system to other European countries and to third countries where agreements can be negotiated on notifications. Finally, the panels will be expected to identify emerging risks, and have wide latitude under the proposal to expand into emerging areas of concern. Our Brussels office suggests that the proposal, in some ways, represents a missed opportunity to reinforce mutual recognition by codifying the practical guidelines issued by the Commission, based on the jurisprudence by the European Court of Justice, on the free movement of foodstuffs in matters not fully harmonized at the EU level. We also are concerned that the proposal may actually provoke a slow-down in the process. There is some potential for confusion, in that SCF and the other scientific committees will remain in place until the EFA is operational, when it will be split from the rest of the Commission's efforts. Further, the transfer of the review function to a new in-house panel will mean that we have a new group of scientists who may have little or no experience in evaluating food packaging. To access the full text of the proposal, visit the Official Journal Web site at http://europa.eu.int/eur-lex/en/oj/2001/ce09620010327en.html and click on the link to page 247. * * * 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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