Presentation by Mr Bobby Richey Deputy Director Biotechnology Group USDA Foreign Agricultural Service Survey of traceability and labeling regimes in other countries

							Traceability and Labeling:
A Global Perspective

Bobby Richey
Foreign Agricultural Service/USDA
December 5, 2003
Traceability and Labeling:
A Global Perspective
   Key Points
   Motivation
   Global View
   Specific examples
   Implications
Key Points
   Mandatory biotech traceability and labeling
   regimes vary widely
   Countries rapidly adopting or considering a
   variety of biotech labeling regimes
   Many labeling regimes fail to acknowledge
   practical implications
  Why traceability and labeling?
Traceability:
  Market driven
  Mandatory

Labeling:
  Market driven
  Mandatory
Why traceability and labeling?
Economic Interests
  Developing countries want to maintain
  market access to the EU


Consumer Concerns
  EU response to consumer concerns
  Japan/Korea respond to consumer demand
  but opt for less stringent thresholds, more
  practical measures than EU.
Why traceability and labeling?
 Environmental Protection
   Australia/New Zealand respond to
   consumer and environmental concerns


 Market Driven vs. Mandatory
   U.S. opts for voluntary, market-driven
   labeling while EU responds to consumer
   demand for mandatory biotech labeling
Sometimes the reasons and
policies are unclear…
China
India
Brazil
Traceability and Labeling
Requirements Worldwide
Country        Mandatory             Threshold     Enforced?   Mandatory Biotech
               Biotech Labeling?                               Documentation Required?
Argentina      No                    No            (n/a)       No
Australia/NZ   Yes                   1%            Yes         Yes – to maintain integrity of
                                                               labeling regime
Bolivia        Yes                   No            No          No
Brazil         Yes                   1%            No          No
Canada         No                    No            (n/a)       No
China          Yes                   No            Yes, but    No
                                                   uneven
Colombia       Yes                   No            Yes         No
Croatia        Yes                   No            Yes         Yes
Estonia        Yes                   1%            Yes         No
EU             Yes                   1% (0.9%      Yes         Yes – as of 4/04
                                     as of 4/04)
India          No, but considering   1%            (n/a)       No
Indonesia      Yes                   5%            No          No, but considering
Japan          Yes                   5%            Yes         Yes – documentation required
                                                               for non-biotech labeling
Korea          Yes                   3%            Yes         Yes – documentation required
                                                               for non-biotech products
                                                               (exemption from labeling)
Country        Mandatory             Threshold   Enforced?   Mandatory Biotech
               Biotech Labeling?                             Documentation Required?
Malaysia       No, but considering   No          (n/a)       No
Mauritius      No                    No          (n/a)       No, but considering
Poland         Yes, to harmonize     1%          Yes         No, but considering – to
               w/EU                                          harmonize w/EU
Romania        Yes, to harmonize     No          (unclear)   Yes – to harmonize w/EU
               w/EU
Russia         Yes                   5%          No          No
Saudi Arabia   Yes                   1%          Yes         No
Serbia &       Yes, to harmonize     0.9%        No          Yes - “May contain”
Montenegro     w/EU                                          documentation req. for
                                                             imports
Slovakia       Yes, to harmonize     1%          Yes         No, but will harmonize w/EU
               w/EU                                          regs in future
Sudan          No, but considering   No          (n/a)       No, but considering
Taiwan         Yes – beginning       5%          (n/a)       No
               1/1/03
Thailand       Yes                   5%          No          No
U.S.           No                    No          (n/a)       No
Vietnam        Yes                   No          No          No
Zambia         No, but considering   No          (n/a)       No
Traceability and Labeling:
A Closer Look
European Union and Accession Countries
Developing Countries
Japan and Korea
Australia and New Zealand
Canada and Argentina
European Union:
  Traceability and Labeling Regulations
    Mandatory biotech labeling regardless of
    detectability, unless identity preserved
    Mandatory biotech traceability throughout
    the commercial chain
  Products Covered
    All products produced from biotechnology
    including whole grains, food, and feed but
    excluding enzymes and processing aids
    used in the production.
EU Accession Countries:
   Must adopt EU policies as a condition of entry
   Countries entering the EU in May 2004
   include Cyprus, Czech Republic, Estonia,
   Hungary, Latvia, Lithuania, Malta, Poland,
   Slovakia, and Slovenia
   Potential future members, such as Romania,
   Croatia, and Serbia & Montenegro, have or
   are planning to harmonize biotech regulations
   with the EU.
Developing Countries:
   Traceability and Labeling Regulations
     Rudimentary or no regulatory systems
   Products Covered
     Generally unclear what’s covered
   Why?
     Policies in response to general misinformation/lack
     of knowledge about biotech
     Lack of ownership of the technology
     Lack of risk assessment systems/capacity
     External pressures weighing on decision makers
Japan and Korea:
   Traceability and Labeling Regulations
     Mandatory biotech labeling
     3-5 percent labeling threshold
     Documentation requirement for non-biotech
   Products Covered
     Positive product list
   Why?
     Pressure from consumers
Australia and New Zealand:
   Traceability and Labeling Regulations
     Mandatory biotech labeling for 1% or more
     Use of existing IP/QA system permitted
   Products Covered
     Across the board – no products specified
   Why?
     Documentation requirement to maintain
     integrity of labeling regime
Canada and Argentina:
   Traceability and Labeling Regulations
     Mandatory labeling for all products containing
     allergens, nutritional changes, or special handling
     requirements
     No special labeling or product tracing requirements
     for biotech products
   Products Covered
     All products
   Why?
     General trust in the regulatory system
Codex Discussions of
Traceability or Product Tracing:
   Committee on General Principles
   Committee on Food Import and Export
   Inspection and Certification Systems
   Committee on Food Labeling
   Ad Hoc Intergovernmental Task Force on
   Foods Derived from Biotechnology
   Codex Ad Hoc Task Force on Animal Feed
   Codex Committee on Methods of Analysis and
   Sampling
Effects of Mandatory Biotech
Labeling & Traceability:
  Consumer perception potentially skewed
  Market uncertainty
  Loss of markets
  Industry reformulates or re-sources
  Increased demands on regulatory systems
  Increased producer costs
  May force changes in marketing systems
  Reduced investment in R&D