EU and U.S. Food EU and U.S. Food Regulatory Systems Regulatory Systems
Compared: Is There Hope Compared: Is There Hope
for Harmonization?
for Harmonization?
By By
Gary Jay Kushner Gary Jay Kushner
Partner, Hogan & Hartson, LLP Partner, Hogan & Hartson, LLP
Washington, D.C.
Washington, D.C.
November 3, 2005
November 3, 2005
Introduction Introduction
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n The food marketplace has become increasingly The food marketplace has become increasingly global
global
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n Historically, food has been regulated differently in Historically, food has been regulated differently in the United States than throughout the European the United States than throughout the European Union
Union
n
n With the emergence of private standards in the With the emergence of private standards in the EU – EU – and continuing trade competition and and continuing trade competition and
disputes
disputes – – the short term promises more the short term promises more complexity and conflict
complexity and conflict
n
n As food companies become even more global – As food companies become even more global –
and consumers on both sides of the Atlantic focus and consumers on both sides of the Atlantic focus on diet and health
on diet and health – – objectives of international objectives of international regulation become compatible
regulation become compatible
n
n Regulators and industry have shared incentives Regulators and industry have shared incentives
to adopt and implement harmonized schemes
to adopt and implement harmonized schemes
The U.S. Regulatory System The U.S. Regulatory System
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n Food is primarily regulated by two federal Food is primarily regulated by two federal agencies and 50 states
agencies and 50 states
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n FDA has jurisdiction over all food FDA has jurisdiction over all food
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n USDA has jurisdiction over products containing USDA has jurisdiction over products containing more than
more than “ “small amounts small amounts ” ” of meat and poultry of meat and poultry
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n Although state regulation may be preempted by Although state regulation may be preempted by federal law, states have some autonomy and
federal law, states have some autonomy and concurrent jurisdiction
concurrent jurisdiction
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n The differences in statutory authority and The differences in statutory authority and
regulatory philosophy of the federal and state regulatory philosophy of the federal and state agencies with jurisdiction sometimes results in agencies with jurisdiction sometimes results in inconsistent regulation
inconsistent regulation
• • even within U.S. borders even within U.S. borders
FDA Regulatory Focus FDA Regulatory Focus
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n FDA regulates all food/feed except meat FDA regulates all food/feed except meat and poultry
and poultry
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n Deriving its authority from the Federal Deriving its authority from the Federal Food, Drug, and Cosmetic Act
Food, Drug, and Cosmetic Act
• • Goal is to prevent distribution of adulterated or Goal is to prevent distribution of adulterated or misbranded food
misbranded food
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n FDA’ FDA ’ s focus is on food safety and proper s focus is on food safety and proper labeling to ensure that consumers are not labeling to ensure that consumers are not mislead as to product composition or
mislead as to product composition or attributes
attributes
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n Imported products must comply with Imported products must comply with regulations applicable to products
regulations applicable to products produced domestically
produced domestically
USDA Regulatory Focus USDA Regulatory Focus
n
n USDA’ USDA ’ s Food Safety and Inspection Service s Food Safety and Inspection Service administers Federal Meat Inspection Act and administers Federal Meat Inspection Act and Poultry Products Inspection Act
Poultry Products Inspection Act
• • “Continuous inspection, “ Continuous inspection,” ” prior approval of labels, prior approval of labels, enforcement mechanism
enforcement mechanism
• • Prohibits production, processing, and introduction into Prohibits production, processing, and introduction into interstate commerce of adulterated or misbranded meat interstate commerce of adulterated or misbranded meat or poultry
or poultry
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n Focus is on food safety and labeling to prevent Focus is on food safety and labeling to prevent consumers from being mislead
consumers from being mislead
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n Inspection systems of countries seeking to export Inspection systems of countries seeking to export to U.S. (and plants) must be approved by USDA to U.S. (and plants) must be approved by USDA
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n Imported products must comply with the same Imported products must comply with the same
requirements applicable to domestic products
requirements applicable to domestic products
The Federal Trade Commission, The Federal Trade Commission,
the States, and Industry Self the States, and Industry Self - -
Regulation Regulation
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n The Federal Trade Commission regulates food The Federal Trade Commission regulates food advertising and challenges ads that are false or advertising and challenges ads that are false or deceptive
deceptive
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n State Attorneys General can be quite aggressive State Attorneys General can be quite aggressive in challenging misleading promotional materials in challenging misleading promotional materials under state consumer protection laws
under state consumer protection laws
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n Industry monitors competitor labeling and Industry monitors competitor labeling and advertising and often seeks challenge and advertising and often seeks challenge and resolution through the National Advertising resolution through the National Advertising
Division of the Council of Better Business Bureaus
Division of the Council of Better Business Bureaus
Prevailing Legal Standards Prevailing Legal Standards
n
n
Products must be “ Products must be “safe safe” ”
• • “ “ a reasonable certainty of no harm a reasonable certainty of no harm ” ”
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Labeling may not be “ Labeling may not be “false or misleading false or misleading” ”
• • Historically, to the “ Historically, to the “ incredulous incredulous ” ” and “ and “ unthinking” unthinking ” consumer consumer
• • Current trend, to the “ Current trend, to the “reasonable reasonable” ” consumer consumer
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n
Focus of regulation on safety and labeling Focus of regulation on safety and labeling
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n
USDA approach: must be satisfied that product is not USDA approach: must be satisfied that product is not adulterated or misbranded
adulterated or misbranded
• • Continuous inspection Continuous inspection
• • Prior approval Prior approval
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n
FDA approach: products must comply with the law FDA approach: products must comply with the law
• • Random inspection Random inspection
• • Enforcement in the marketplace Enforcement in the marketplace
Recent Initiatives Recent Initiatives
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n Increased focus on relationship between diet and Increased focus on relationship between diet and health
health
• • Health and nutrient content claims Health and nutrient content claims
• • MyPyramid/Dietary Guidelines MyPyramid/Dietary Guidelines
• • Calories Calories
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n FDA and USDA considering modernizing food FDA and USDA considering modernizing food standards of identity
standards of identity
• • Key to product innovation Key to product innovation
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n Food safety focus on sanitation Food safety focus on sanitation
• • FDA updating Good Manufacturing Practices FDA updating Good Manufacturing Practices
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n Some of the same issues are Some of the same issues are “ “ hot topics hot topics ” ” in EU in EU – – approached from a different perspective
approached from a different perspective
History of EU
History of EU Food Food Regulatory Regulatory System
System
n n Originated Originated with with EC Treaty EC Treaty (1957) (1957)
n n After After World World War War II II
n n Goals: Goals:
• • Ensure Ensure availability availability of of supply supply
• • Increase Increase productivity productivity
• • Stabilize Stabilize markets markets
• • Reasonable Reasonable prices prices
• • Fair Fair standard standard of of living for farmers living for farmers
EU Single
EU Single Market Market Programme Programme
n n Adopted Adopted in 1992 in 1992
n n Goal: Goal:
• • free free movement movement of of goods goods ( ( including including food food products) products )
• • again again primarily primarily economic economic driving driving force force
Evolution
Evolution of of EU EU System System
Food Food chain chain has has changed changed dramatically, dramatically , particularly
particularly since since early early 1990s: 1990s:
• • Rise Rise in trade in trade across across national borders national borders
• • Increasingly Increasingly complex complex food food processing processing and and distribution network distribution network
• • Emergence Emergence of of new scientific new scientific techniques techniques
EU EU Regulatory Regulatory Approach Approach
However However: :
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n Regulatory Regulatory policy policy did did not not develop develop at at same same speed speed
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n Food F ood safety safety crises show weaknesses crises show weaknesses in system in system, , and and : :
EU Member States have had to comply with EU Member States have had to comply with prohibitions on restrictions on trade in goods, prohibitions on restrictions on trade in goods, except where justified on grounds of
except where justified on grounds of “the “ the
protection of health and life of humans, animals protection of health and life of humans, animals or plants
or plants” ” (principle enshrined in EC Treaty) (principle enshrined in EC Treaty)
European Food Safety Authority European Food Safety Authority
n n In order In order to restore Consumer to restore Consumer Confidence
Confidence
• • European Food Safety Authority (EFSA) European Food Safety Authority (EFSA) - - European Parliament and Council European Parliament and Council
Regulation 178/2002 Regulation 178/2002
• • Consumer dialogue Consumer dialogue
• • Review Review food food safety safety legislation legislation
Principles
Principles of of EU EU Food Food Law Law
n n Protection Protection of of Health Health
n n Protection of Protection of Consumer Interests Consumer Interests
• • Informed Informed choice choice
• • No misleading No misleading information information
n n Risk Risk Analysis Analysis
• • Risk Risk Assessment Assessment and and Management Management
n n Precautionary Precautionary Principle Principle
• • Permits Permits provisional provisional measures measures to be to be taken taken pending
pending further further scientific scientific assessment assessment
Requirements
Requirements of of EU EU Food Food Law Law
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n Food/ Food / Feed Feed Safety Safety requirements requirements
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n Responsibilities Responsibilities on on food/ food /feed feed business business operators
operators
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n Traceability Traceability
Internal Challenges for the EU Internal Challenges for the EU
n n EFSA: internal (EU) focus vs. EFSA: internal (EU) focus vs.
“external “ external ” ” pressure pressure
n n EU Enlargement EU Enlargement
n n Focus of Common Agricultural Policy Focus of Common Agricultural Policy
External Challenges External Challenges
n
n WTO (and other) international obligations and WTO (and other) international obligations and bilateral agreements
bilateral agreements
• • Is no longer just about Is no longer just about “ “ traditional traditional ” ” matters (tariff matters (tariff quotas; tariffs)
quotas; tariffs)
• • Market access increasingly determined by domestic Market access increasingly determined by domestic regulations and other
regulations and other “ “behind the border behind the border ” ” issues issues
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n Need for improved regulatory framework and Need for improved regulatory framework and scientific cooperation, not only between EU and scientific cooperation, not only between EU and U.S., but also:
U.S., but also:
• • Between EU Member States & European Commission/ Between EU Member States & European Commission/
EFSA EFSA
• • At international level, including developing countries At international level, including developing countries (WTO, Codex,
(WTO, Codex, Cartagena Cartagena Protocol, OECD, OIE, G8, IPPC, Protocol, OECD, OIE, G8, IPPC, etc.)
etc.)
Effects
Effects of of Globalization Globalization on on Food Food Trade Trade
n n Erosion Erosion of of distinction between distinction between domestic
domestic and and international concerns international concerns
n n Increased economic integration Increased economic integration – – more opportunities for conflict
more opportunities for conflict
n n Tension between Tension between
• • civil society and governments civil society and governments
• • developed and developing developed and developing countries
countries
International Implications International Implications
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n EU food crises/issues take on an international EU food crises/issues take on an international character
character
• • BSE BSE
• • FMD FMD
• • Biotech Biotech
• • Lysteria Lysteria
• • Dioxin Dioxin
• • Acrylamide Acrylamide
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n EU standard EU standard - - setting from setting from “ “ farm to table farm to table ” ” has an has an international impact
international impact
• • Traceability Traceability
• • Labeling Labeling
• • Precautionary principle Precautionary principle
EU and U.S. Perception of Each EU and U.S. Perception of Each
Others Systems Others Systems
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n U.S. thinks EU system is U.S. thinks EU system is
• • Parochial Parochial
• • Protectionist Protectionist
• • Precautionary Precautionary
• • Political Political
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n EU thinks EU thinks U.S. system U.S. system is is
• • Protectionist Protectionist and and political political
• • Presumptuous Presumptuous
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Works fine for U.S. but EU requires Works fine for U.S. but EU requires different different framework framework
• • Not Not the the only only manner manner by which by which to regulate to regulate
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n
Food Food is is cultural in EU cultural in EU
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n
