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Food Contact Legislation for US Markets PDF

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Food Contact Legislation for US Markets The Packaging Group at Keller and Heckman LLP Published by Pira International Ltd Cleeve Road, Leatherhead Surrey kt22 7ru UK T +44 (0) 1372 802080 F +44 (0) 1372 802079 E [email protected] W www.piranet.com Without limiting the rights Acknowledgements under copyright reserved above, no part of this publication may This book could not have been prepared without the invaluable contributions of Keller and be reproduced, stored in or introduced into a retrieval Heckman LLP attorneys Colleen M. Evale, David J. Ettinger, John F. Foley, Devon W. Hill, system, or transmitted, in any Jeffrey A. Keithline, Sarah A. Kornblet, Pamela L. Langhorn, Mitzi L. Ng, Katherine M. form, or by any means Norman, and Karen L. Rothschild, and scientists Charles V. Breder, Lester Borodinsky, (electronic, mechanical, Michael T. Flood, Holly H. Foley, and Dorothy Wyatt. We also wish to thank Gaynelle Brent photocopying, recording, or otherwise), without the prior for her contributions to this book. written permission of the copyright owner of this book. NOTE: The content of this book is based on information believed to be accurate The scanning, uploading, and and reliable as of the date of publication. Administrative and judicial interpretations, as distribution of this book via the Internet or via any other means well as the rules themselves, are subject to changes. The general presentation of FDA’s without the permission of the rules and policies in this volume is not intended as, and does not constitute, legal advice publisher is illegal and for particularized facts. Regulatory counsel should be consulted for advice on particular punishable by law. Please purchase only authorized compliance issues. electronic editions, and do not participate in or encourage electronic piracy of copyrighted materials. Your support of the authors’ rights is appreciated. This material is intended for educational use only. 2005 © Copyright Keller and Heckman LLP, 1001G Street, N.W., Washington, D.C. 20001, www.khlaw.com and www.packaginglaw.com. All Rights Reserved. ISBN 1 85802 984 8 Head of publications and events Philip Swinden [email protected] Customer services manager Denise Davidson [email protected] T +44 (0)1372 802080 Typeset in the UK by Jeff Porter, Deeping St James, Peterborough,Lincs [email protected] Contents 5 Acknowledgements ii List of tables vi The authors vii Introduction: the regulation of food- contact materials in the US ix Explicit FDA sanctions of food- 1 contact materials 17 The food additive regulations 17 The lay of the land—direct, secondary, and indirect food additives 17 The history of FDA’s regulation of Applicability of a given regulation—the food-contact materials 1 questions to ask 18 The Pure Food and Drug Act, 1906 1 The structure of a single regulation 19 The Federal Food, Drug, and Cosmetic Act, FDA’s good manufacturing practices 1938 1 requirement—21 C.F.R. 174.5 24 Amendments 2 The mixture doctrine 26 2 Threshold of regulation 27 Food-contact notifications 27 6 State versus federal authority 9 3 Examples of specific regulations 29 Adhesives 29 Can coatings 30 Setting the stage: food, food History 30 additives, and food-contact Framework of Section 175.300 31 substances 11 Paper and paperboard 31 Definition of food 11 Colorants 33 Definition of food additive 11 Irradiated food packaging 33 Definition of food-contact substance 12 Irradiation of food products 34 4 Irradiation of pre-packaged food 34 7 The adulteration standard of the FD&CAct 13 Exemptions from pre-market Section 402—general 13 regulatory authority 37 Section 402 and Section 409 14 No migration/no food additive Safety criteria—reasonable certainty of no position 37 harm 15 What is “no migration”? 37 Page iii © Copyright 2005Keller and Heckman LLP Food Contact Legislation for US Markets Contents Demonstrating no migration 38 Safety of the additive 68 Functional barrier doctrine 39 Environmental assessment 69 11 GRAS substances 40 GRASlistings 40 GRAS notification procedure 41 Determining GRASstatus 42 Prior sanctions 44 Protecting confidential information 71 History 44 Freedom of Information Act 71 Special case of PVC 45 Confidential business information 71 Housewares 46 Safety and chemistry information 71 Basic resin doctrine 48 Structuring FDA submissions to protect 8 confidential business information 72 Food additive master files 72 Disclosure of non-confidential information—when and where 72 12 Special issues 53 Recycled packaging in contact with food 53 Printing inks 54 Active and intelligent packaging 55 Customer assurance 75 Solvents 57 Compliance letters 75 Modified atmosphere packaging 57 Section 303 guaranty 75 9 Liability 76 Third-party certifications 77 13 Food-contact notifications 61 Overview 61 The FCNprocess 62 Formal and informal advisory Changes to an existing FCN 64 opinions 79 10 14 Filing a food additive petition or FDAenforcement authority 81 food-contact notification 67 Strict liability 81 Composition and method of Civil and criminal liability 82 manufacture 67 Prohibitions under the Act 82 Intended conditions of use 67 Judicial options to stop behaviors 82 Amount of additive in food and entering Non-judicial steps to stop behaviors 83 the diet 68 Page iv © Copyright 2005Keller and Heckman LLP Food Contact Legislation for US Markets Contents 15 The Toxic Substances Control Act 93 The TSCA definition of “chemical substance” 93 TSCAInventory and Premanufacture Other laws bearing on food Notification 94 packaging 85 Regulation of antimicrobials in food Bioterrorism Act 85 packaging 95 16 CONEGheavy metals statutes 87 The California Safe Drinking Water and Toxic Enforcement Act of 1986 89 State recycling laws 90 State coding laws 92 Conclusion 99 Page v © Copyright 2005Keller and Heckman LLP List of tables 5.1 Categories of food types 20 5.2 Conditions of use 22 Page vi © Copyright 2005Keller and Heckman LLP The authors Joan S. Baughan Ms Baughan’s practice concentrates on Food and Drug Administration and comparable international regulation of food contact materials, drugs, cosmetics, and medical devices. In addition to practicing in the firm’s Washington office, she spent two years counseling foreign and domestic clients from the firm’s Brussels, Belgium office, where she focused on the regulation of food packaging materials and medicinal products under European Union and Member State legislation. Ms Baughan has a scientific background in microbiology and medical technology. John B. Dubeck Mr Dubeck’s scientific background (chemical engineering and nuclear propulsion systems) assists him in his largely science-based practice, representing clients and trade associations before the Food and Drug Administration (FDA), US Department of Agriculture and the Environmental Protection Agency (toxic substances and pesticides). Biotechnology-derived products are becoming an increasing part of his practice. Mr Dubeck has helped clients bring hundreds of products to market in an efficient manner, advises on continuing compliance obligations, and defends enforcement actions. He has been a presenter at numerous conferences on toxic chemicals, pesticides, and medical device and drug regulation. He has taught a popular Practical Food Law course annually since 1982. Jerome H. Heckman A founding partner of the firm, Mr Heckman is a recognized expert in food and drug law. He represents domestic and foreign corporations and trade associations before the FDA, the Environmental Protection Agency, the Department of Agriculture, the Federal Trade Commission, the Occupational Safety and Health Administration and comparable regulatory authorities in other countries. His expertise extends to all aspects of FDA law and his client base includes the full spectrum of FDA-regulated industries, including chemical, food, and other manufacturing firms. Since 1954, Mr Heckman has served as General Counsel to The Society of the Plastics Industry, Inc. and represents The Society before congressional committees, state governmental bodies, and administrative agencies. Mr. Heckman was inducted into the Plastics Hall of Fame in 1986and was awarded the Spes Hominum medal by the National Sanitation Foundation in 1987. He has been a member of the Board of Editors of the Food Drug Cosmetic Law Journaland has authored more than 125papers on issues involving food and drug packaging, product liability, and trade associations. He is also a frequent speaker on food and drug matters and is listed in Who’s Who in Americaand Who’s Who in American Law. On June 23, 2000, Mr Heckman was presented with a Director’s Special Citation Award by Joseph A. Levitt, Director for Food Safety and Applied Nutrition of the FDA for “sustained and successful participation in the establishment of a new, fully funded system for FDA approval of Food Contact Page vii © Copyright 2005Keller and Heckman LLP Food Contact Legislation for US Markets The authors Substances” [The new Food Contact Notification System]. In 2001, Georgetown University presented him with the Paul R. Dean Distinguished Alumni Award. George G. Misko Prior to joining Keller and Heckman, Mr Misko was Senior Regulatory Counsel for the Chemical Specialty Manufacturers Association (now known as the Consumer Specialty Products Association), where he provided counsel on a broad range of environmental, and health and safety issues. Mr Misko also is an experienced civil trial and appellate litigator, and served as a law clerk to the Honorable Nicholas S. Nunzio, Judge of the Superior Court of the District of Columbia. He currently writes a monthly column on regulatory issues for Food and Drug Packagingmagazine, which is available at www.fdp.com. Mr Misko’s practice is focused on food and drug matters, and environmental concerns, including pesticide regulation, right-to-know laws, and toxic substance control regulations. Catherine R. Nielsen Ms Nielsen represents domestic and foreign corporations on a variety of food, drug, cosmetic and environmental matters. She specializes in counseling clients on the regulatory status of foods and food additives before the US FDA. In addition, Ms Nielsen advises clients about the regulatory status of packaging in Canada, Europe, Central and South America, and the Pacific Rim, and has significant experience in obtaining explicit regulatory listings of packaging products in various jurisdictions. Ms Nielsen also advises companies on compliance with the California Safe Drinking Water and Toxic Enforcement Act (Proposition 65), CONEG-heavy metals legislation, and state recycling laws, as well as other regulatory compliance issues relating to packaging. Ralph A. Simmons Mr Simmons counsels a variety of domestic and foreign companies on food, drug, cosmetic and medical device product and packaging regulated by the FDA, the US Department of Agriculture, and other federal and state agencies. He advises clients about comparable international regulatory structures, including Canada, Mexico, Europe, Central and South America, the Caribbean, the Pacific Rim, and Africa. He also represents clients on US (federal, state, and local) and international environmental laws and regulations relating to the manufacture, labeling and disposal of products and packaging. In addition, Mr Simmons acts as general counsel to several trade associations, advising them on compliance with the antitrust laws and tax and other business issues. He is a published author and frequent speaker on US and international health and safety and environmental laws and regulations. Mr Simmons clerked for the Honorable George H. Goodrich, Judge of the Superior Court of the District of Columbia, before entering private practice. Page viii © Copyright 2005Keller and Heckman LLP Introduction: the regulation of food-contact materials in the US By design, packaging materials are intended to be one of the most effective and important safeguards against food contamination. Tremendous strides in the protection of human health and the expansion of global markets for food products are directly attributable to advancements in food packaging technology: foods are safer, more accessible, and more affordable than they have been at any other time in our history. The only federal agency that directly passes on the safety of food-contact materials in the US is the US Food and Drug Administration (FDA). Compliance with its requirements means a great deal more than permission to sell a product for the applications covered by a particular clearance. First and foremost, compliance means that food manufacturers can confidently sell their foods with the knowledge that their products are appropriately protected and safe for people to eat and drink. For exporters of food to the US, compliance with FDA’s food packaging requirements brings one less obstacle into play in opening the doors to the world’s largest economy. For US exporters of food to a host of countries world- wide, FDA food packaging compliance may mean that the packaging is automatically considered safe and suitable for the intended use in those countries as well. For US FDA drug reviewers, food packaging compliance means added assurance that the package is unlikely to present safety issues when used to hold pharmaceuticals. Even manufacturers of consumer items like toys often insist on using only materials that comply with the FDA requirements for food packaging, reasoning that “if it’s safe for food-contact, it’s safe for my products, too.” As the agency whose mission is to protect human health by assuring the safety of the US’s food supply, FDA treats its obligations with tremendous dedication. Significant resources—in time, money, and personnel—are expended by FDA in regulating food packaging. Where FDA review is triggered, FDA’s foremost scientists in the agency’s Office of Food Additive Safety (OFAS) assess the food contact materials and their suitability for the intended uses. The agency’s staff of scientists who review food-contact notifications includes some 33chemists, toxicologists and consumer safety officers in the Division of Food Contact Substance Notification Review, as well as four environmental scientists in the Division of Chemistry Research and Environmental Review, both under the umbrella of OFAS. These dedicated governmental officials work to ensure that the package—designed to prevent contamination, premature spoilage, and preserve food flavor—itself does no harm. And the Agency’s results are impressive. FDA’s food additive regulations, effectively static since passage of the Food and Drug Administration Modernization and Accountability Act (FDAMA) of 1997, number over 320pages, still in excess of the 260or so pages of ostensibly growing “direct food additive” regulations (“direct” meaning materials added directly to food to have a technical effect in the food). Further, in the latter part of 2005, FDAMA’s Food Contact Notification count was well over 400and rising. It was with this Food Contact Notification program that the Agency rectified a 40-year lack of rationality in the regulation of food-contact materials. Ironically, until passage of FDAMA in 1997, the regulation of food-contact substances in the US tracked that of direct Page ix © Copyright 2005Keller and Heckman LLP Food Contact Legislation for US Markets Introduction food additives. The law governing food-contact materials and their clearances is the Food Additives Amendment of 1958which, until it was amended by FDAMA, made no clear distinction between direct additives and food-contact substances, or “indirect additives.” The two types of potential additions to foodstuffs were regulated in essentially the same way—by food-additive regulations issued in response to food-additive petitions—even though the one class of materials, direct additives, are added to food for a specific technical effect and ingested, while the other, “indirect additives” or “food-contact substances,” are not intended to be added to food at all. Instead, they are designed only to protect and preserve the food from contamination. With passage of FDAMA, FDA put in place its Food Contact Notification system for food-contact substances, altering the system at its core and significantly reducing the FDA review times for food packaging submissions. FDA’s current regulatory scheme is one in which most plastic, paper, aluminum, and glass packaging substances are either covered by the old (but still applicable) food additive regulations, Threshold of Regulation letters, or FCNs, or are “exempt” from application of the Federal Food, Drug, and Cosmetic Act under well established legal principles. Knowing how to determine status under the law, and being able to identify the correct course of action that will allow one to obtain or give satisfactory assurance that a food-contact substance is suitable for its intended use, is the daily task of many company chemists, toxicologists, and regulatory personnel. Theirs is the job of determining what regulatory and technical principles apply so that they can deal in a practical way with the complexities of the Food Additives Amendment of 1958in marketplace settings. What Keller and Heckman LLP’s lawyers attempt to do in the pages that follow is summarize the regulatory framework that applies to food packaging materials in the US and to assist the regulated community in understanding the laws, regulations, policies, and culture that make up FDA’s food packaging system. In considering what follows two all-pervasive concepts are crucial. First, the rules and exemptions that can be used to avoid pre-market clearance by FDA, and that are described here, may be applied only where there is no safety or public health question about the use of a component or formulation. If a substance actually presents a public health threat, the only principle that applies is that it should not be sold or used; if FDA is required to move in such a situation, the courts are likely to uphold any action FDA takes to prevent the adulteration of food. Second, the actual intended conditions of use of the food-contact substance are critically important to a determination of its legal status in the US. More costly mistakes have been made by ignoring this principle than any other. For example, blindly clearing a substance in a conventionally broad way, as if it will directly contact all foods, when it will only be used in an outer layer of a package separated from food by a functional barrier, or in limited food applications (e.g. aqueous food only) can result in wasted time, money, and energy. Further, conclusions regarding the food-contact status of a material will frequently vary depending on the particular structure of the article in question, the formulation under consideration, and the specific applications of concern. It is generally inappropriate to rely Page x © Copyright 2005Keller and Heckman LLP

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