1. The United States Experience Implementing the WTO SPS Agreement Hangzhou, China December 2008 Roseanne Freese Senior WTO SPS Affairs Officer United States SPS Enquiry Point United States Department of Agriculture Foreign Agricultural Service

2. 2 U.S. Implementation of WTO Agreements: History Trade Expansion Act (1962) President establishes interagency trade policy process and appoints special Representative for Trade. Uruguay Round Act (1994) Authorized USTR as lead responsible for all negotiations and enforcement of negotiations under the WTO. Recognized USDA Foreign Agricultural Service as the SPS National Notification and Enquiry Point Authority. Trade and Development Act (2000)—created Chief Agricultural Negotiator.

3. 3 U.S. SPS Agencies Office of the U.S. Trade Representative Foreign Agricultural Service Regulatory Agencies APHIS – Animal and Plant Health Inspection Service FSIS – Food Safety Inspection Service FDA – Food and Drug Administration EPA – Environmental Protection Agency Department of Commerce Department of State

4. 4 U.S. SPS Regulatory Agencies and Their Portfolios USDA ANIMAL AND PLANT HEALTH INSPECTION SERVICE USDA FOOD SAFETY AND INSPECTION SERVICE ALL IMPORTED PLANTS AND PLANT PRODUCTS INCLUDING WOOD PRODUCTS ALL IMPORTED LIVE ANIMALS AND ANIMAL PRODUCTS DETERMINES ENTERABILITY OF A COMMODITY BASED ON THE DISEASE AND PEST STATUS OF THE COUNTRY MUST DETERMINE DISEASE FREE STATUS BEFORE MEAT/ POULTRY IMPORTS CAN BE APPROVED BY FSIS ALL MEAT AND POULTRY PRODUCTS AND PROCESSED EGGS PROCESSED PRODUCTS CONTAINING 2% OR MORE COOKED POULTRY OR 3% OR MORE BEEF WORKS WITH FOREIGN COUNTRIES TO APPROVE MEAT INSPECTION SYSTEMS NOTE: MORE THAN ONE U.S. AGENCY MAY HAVE REGULATORY AUTHORITY OVER THE SAME COMMODITY. * DRUGS AND COSMETICS FOOD, FISH, AND MEATS (SUCH AS GAME MEAT) NOT COVERED BY FSIS, U.S. BIOTERRORISM ACT OF 2002 CAN ISSUE CERTIFICATES OF FREE SALE/EXPORT AND SOME EU CERTIFICATES CONTAMINANTS ENFORCES PESTICIDE LIMITS SETS MAXIMUM RESIDUE LEVELS FOR PESTICIDE USE FDA & USDA ENFORCE PESTICIDE LEVELS SET BY EPA ENVIRONMENTAL PROTECTION AGENCY HHS FOOD AND DRUG ADMINISTRATION

5. 5 THE TRADE POLICY SUB COMMITTEE FOR SPS AFFAIRS (TPSC): WTO SPS COMMITTEE USTR FOR SPS AFFAIRS (CHAIR) FDA OVERSEAS OFFICE STATEAPHIS OVERSEAS OFFICES APHIS VETERINARY SERVICES APHIS PLANT PROTECT- ION AND QUARANTINE FAS U.S. SPS ENQUIRY POINT U.S. SPS NATIONAL NOTIFICATION AUTHORITY PRIVATE SECTOR FAS OVERSEAS OFFICES EPAFSIS

6. 6 BENEFITS OF TPSC STRUCTURE 1. Clarifies participants and their roles in trade policy review and formulation 2. Helps ensure an equal voice for all stakeholders 3. Mandates consensus building 4. Recognizes value of interagency communication and information sharing

7. 7 BENEFITS OF TPSC STRUCTURE 5.Recognizes that coordination is essential to maintaining SPS market access 6.Recognizes the contribution of all regulatory agencies in identifying 1.Priorities 2.Strategies 3.Steps for resolution

8. 8 The U.S. Regulatory Process Works to Ensure That U.S. Measures Are Consistent with WTO Obligations Protect public health and animal and plant life and health Science-based Equivalent Regionalization Harmonization Transparency Least trade restrictive

9. 9 U.S. WORK MONITORING FOREIGN SPS MEASURES WTO OBLIGATIONS ARE NOT PRODUCT SPECIFIC  Is there a plant, animal, or public health concern?  Is there an international standard to address the health concern?  If additional protection is necessary to meet the appropriate level of protection, has the importing Member conducted a risk assessment to evaluate the need for regulation? 1. Collective review by the SPS TPSC leads to more effective implementation of WTO SPS obligations

10. 10 U.S. WORK MONITORING FOREIGN SPS MEASURES  Is the proposed measure the least trade restrictive possible for effectively mitigating the risk?  Are national borders being used to create an inappropriate SPS Barrier?  Could imports be subject to an SPS standard that domestic products are not? 2. During interagency review, we also consider the following:

11. 11 WTO SPS AGREEMENT OBLIGATIONS ARE NOT PRODUCT SPECIFIC  Transparency – Has the country notified the supporting legislation?  Equivalence – Is certification of processing plants, laboratories, and standards taking place at the appropriate level?  Regionalization of pest- and disease-free areas -- Are import controls enacted at the appropriate level?

12. 12 U.S. SPS National Notification Authority Collects, Prepares and Notifies All U.S. Regulatory Agency Draft Measures to the WTO U.S. NNA Document Staff Database staff add U.S. WTO notifications to WTO World Notifications Newsletter Every Week Final copies sent back to agencies for their records WTO Secretariat issues Official notifications WTO Members submit their comments to the U.S. SPS Enquiry Point for consideration

13. 13 How U.S. Official Comments on Foreign SPS Measures Are Prepared and Submitted to Foreign Governments AMSAPHISFDAFSISEPAGIPSADOC TTB FAS SPS (IRSD) Staff Coordinate USG Comments FAS Overseas Posts Foreign SPS Enquiry Point FAS United States SPS Enquiry Point Inter-Agency Review and Clearance: (Policy Representatives of APHIS, DOC, EPA, FAS, FDA, FSIS, State, and USTR) SPS Database Staff Update SPS &TBT World News Report SPS Document Staff FAS Policy Experts and Posts Industry

14. 14 The United States Is Committed to WTO Compliance The average number of U.S. notifications per year is approaching a record 300 per year, requiring more staff to acquire, notify, and consult on the status of U.S. notifications

15. 15 Growth in the Number of Foreign SPS Measures Since Implementation of the WTO SPS Agreement in 1996 The Volume of Measures Has Grown Tremendously – Requiring more coordination, more texts, more translations, and more consultation

16. 16 Monitoring of Foreign SPS Measures Requires Immense Resources More measures are coming from trade blocs and more measures are amended requiring more review for trade consistency and trade application 11.4% 3.3% 10.7% 13.9% 11.1% 14.2% 17.4% Percentage of Total Foreign SPS measures

17. 17 U.S. ANIMAL HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied

18. 18 U.S. PLANT HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied

19. 19 U.S. PROCESSED FOOD PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied

20. 20 SPS MACRO PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied

21. 21 Things We Have Learned The value of strong interagency communication in developing responses Strong and clear communication with trading partners leads to a better understanding of the areas of concern The multitude of approaches to SPS management The variety of needs for SPS capacity building

22. 22 Things We Have Learned The importance of cooperation between the U.S. Government and our private sector in maintaining market access: to provide input regarding the impact of foreign SPS measures to facilitate translation of technical measures to offer solutions that will benefit the importing and exporting Members

23. 23 In Conclusion…The U.S. Experience 1. Development of a strong interagency process with support from above allows us to effectively implement our rights and obligations. 2. Our regulatory agencies have worked hard to ensure that our measures are science based and we can back the measures with sufficient scientific data. 3. Daily and weekly communication among agencies has helped us to build a strong SPS program.

24. 24 Roseanne.freese@fas.usda.gov Roseanne.freese@fas.usda.gov Your comments are welcome ！ Thank You ！