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

CountryMandatory Biotech Labeling? ThresholdEnforced?Mandatory Biotech Documentation Required? ArgentinaNo (n/a)No Australia/NZYes1%YesYes – to maintain integrity of labeling regime BoliviaYesNo BrazilYes1%No CanadaNo (n/a)No ChinaYesNoYes, but uneven No ColombiaYesNoYesNo CroatiaYesNoYes EstoniaYes1%YesNo EUYes1% (0.9% as of 4/04) YesYes – as of 4/04 IndiaNo, but considering1%(n/a)No IndonesiaYes5%NoNo, but considering JapanYes5%YesYes – documentation required for non-biotech labeling KoreaYes3%YesYes – documentation required for non-biotech products (exemption from labeling)

CountryMandatory Biotech Labeling? ThresholdEnforced?Mandatory Biotech Documentation Required? MalaysiaNo, but consideringNo(n/a)No MauritiusNo (n/a)No, but considering PolandYes, to harmonize w/EU 1%YesNo, but considering – to harmonize w/EU RomaniaYes, to harmonize w/EU No(unclear)Yes – to harmonize w/EU RussiaYes5%No Saudi ArabiaYes1%YesNo Serbia & Montenegro Yes, to harmonize w/EU 0.9%NoYes - “May contain” documentation req. for imports SlovakiaYes, to harmonize w/EU 1%YesNo, but will harmonize w/EU regs in future SudanNo, but consideringNo(n/a)No, but considering TaiwanYes – beginning 1/1/03 5%(n/a)No ThailandYes5%No U.S.No (n/a)No VietnamYesNo ZambiaNo, but consideringNo(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