Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

from different countries are difficult for the FDA to oversee, leading to redundant inspections and conformity assessments. The unbundled supply chain is a logistical and regulatory problem for the FDA; it is also a failure from the trade perspective because lack of cooperation hinders free trade. Promoting regulatory cooperation and convergence in this context can help advance both U.S. trade and regulatory objectives.

U.S. bilateral and regional trade agreements can establish the structures and incentives necessary to develop and adopt common standards, policies, and assessment procedures for emerging or persistent food and drug regulatory challenges. The WTO SPS and Technical Barries to Trade (TBT) committees convene officials from 157 member countries to discuss regulations, standards, testing, and certification procedures in connection with food and drugs. The mandates of these committees include sharing information, promoting the adoption of international standards, and providing technical assistance to developing country members.,^7,⁸ These committees provide potentially useful venues for building consensus for common regulatory approaches on difficult food and drug safety challenges.

The FDA should work harder to make the adoption of international food and drug safety standards a priority in the United States. The consistent use of standards in the U.S. market could motivate trading partners to do the same (Roberts and Josling, 2011). Even where the FDA cannot adopt an international food safety standard, it should work with other industrialized countries to streamline the means by which low- and middle-income countries can demonstrate conformity or comparability (Horton and Wright, 2008). The USTR should work with the FDA to use trade negotiations and forums such as the WTO TBT and SPS committees to promote the adoption of international, risk-based, commodity-specific performance standards for food and medical products.

EXPANDING ONE-UP, ONE-BACK TRACK AND TRACE

Counterterrorism requires that food companies be able to identify the immediate previous and immediate subsequent recipient of all the products in their supply chains (Gessner et al., 2007). This is called one-up, one-back traceability. The committee recognizes that expanding the

⁷ Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1B, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 121 (1999), 1867 U.N.T.S. 493 (1994), art. 3, 5, 9.

⁸ Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1B, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 59 (1999), 1868 U.N.T.S. 120 (1994), art. 5.4, 12.7-.8, 13.1.

Table of Contents

Front Matter R1-R18

Summary 1-12

1 Introduction 13-32

2 Core Elements of Regulatory Systems 33-78

3 Critical Issues 79-146

4 A Strategy to Building Food and Medical Product Regulatory Systems 147-164

5 International Action 165-192

6 Domestic Action 193-234

7 Conclusions and Priorities 235-242

Appendix A: Glossary 243-252

Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation 253-272

Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China 273-282

Appendix D: Chinese Food Regulatory System 283-296

Appendix E: Meeting Agendas 297-318

Appendix F: Committee Member Biographies 319-328

Appendix G: Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed 329-344

Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration 345-348