Food Contact Legislation for US Markets

112 Pages·0.696 MB·English

by  Pira International Ltd

Food Contact Legislation for US Markets
The Packaging Group at Keller and Heckman LLP
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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
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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
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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
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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
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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