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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

U.S. Implementation of WTO Agreements: History

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Trade Expansion Act (1962) President establishes interagency trade policy process and appoints special Representative for Trade.

Uruguay Round Act (1994)

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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 .

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U.S. SPS Agencies

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Office of the U.S. Trade Representative Foreign Agricultural Service Regulatory Agencies

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APHIS – Animal and Plant Health Inspection Service FSIS – Food Safety Inspection Service FDA – Food and Drug Administration EPA – Environmental Protection Agency

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Department of Commerce Department of State

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U.S. SPS Regulatory Agencies and Their Portfolios

NOTE: MORE THAN ONE U.S. AGENCY MAY HAVE REGULATORY AUTHORITY OVER THE SAME COMMODITY.

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 ENVIRONMENTAL PROTECTION AGENCY

SETS MAXIMUM RESIDUE LEVELS FOR

PESTICIDE USE FDA & USDA ENFORCE PESTICIDE LEVELS SET BY EPA HHS FOOD AND DRUG ADMINISTRATION * 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

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THE TRADE POLICY SUB COMMITTEE FOR SPS AFFAIRS (TPSC):

WTO SPS COMMITTEE USTR FOR SPS AFFAIRS (CHAIR) FDA STATE APHIS FAS EPA FSIS FDA OVERSEAS OFFICE APHIS OVERSEAS OFFICES APHIS VETERINARY SERVICES APHIS PLANT PROTECT ION AND QUARANTINE U.S. SPS ENQUIRY POINT U.S. SPS NATIONAL NOTIFICATION AUTHORITY PRIVATE SECTOR FAS OVERSEAS OFFICES

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BENEFITS OF TPSC STRUCTURE

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2.

3.

4.

Clarifies participants and their roles in trade policy review and formulation Helps ensure an equal voice for all stakeholders Mandates consensus building Recognizes value of interagency communication and information sharing

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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.

3.

Strategies Steps for resolution

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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

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U.S. WORK MONITORING FOREIGN SPS MEASURES WTO OBLIGATIONS ARE NOT PRODUCT SPECIFIC 1. Collective review by the SPS TPSC leads to more effective implementation of WTO SPS obligations

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?

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U.S. WORK MONITORING FOREIGN SPS MEASURES

2. During interagency review, we also consider the following:

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?

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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?

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U.S. SPS National Notification Authority Collects, Prepares and Notifies All U.S. Regulatory Agency Draft Measures to the WTO

WTO Secretariat issues Official notifications

WTO Secretariat

Database staff add U.S. WTO notifications to WTO World Notifications Newsletter Every Week

U.S. NNA Database Staff

WTO Members submit their comments to the U.S. SPS Enquiry Point for consideration

U.S. NNA Document Staff

Final copies sent back to agencies for their records

Animal and Plant Health Inspection Service Food Safety Inspection Service Environmental Protection Agency Food and Drug Administration

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

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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 350 300 250 200 150 100 50 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 No v 2 0 2 00 8 Total Number of U.S. WTO SPS Notifications

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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 900 800 700 600 500 400 300 200 100 0 19 96 19 97 19 98 19 99 20 00 20 01 20 02 20 03 20 04 20 05 20 06 N 20 ov 07 2 0 20 08 Total Number of Foreign WTO SPS Measures Reviewed by the United States

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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 Percentage of Total Foreign SPS measures 120 14.2% 13.9% 100 11.1% 80 60 40 20 3.3% 11.4% 17.4% 10.7% 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Nov 20 2008 Number of Foreign SPS Measures Commented on by the United States

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80 70 60 50 40 30 20 10 0 U.S. ANIMAL HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied Animal Disease Monitoring and Quarantine Livestock and Poultry Inspection Meat Product Handling HACCP Dairy Safety Aquatics Safety

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18 16 14 12 10 8 6 4 2 0 U.S. PLANT HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied Plant Pests Plant Health and Inspection Crop Management Plant Health Pest Risk Analysis

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U.S. PROCESSED FOOD PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied 10 5 0 Good Agricultural Practices Processed Food Inspection Processed Food Safety Labeling Codex Canning and Food Contact Materials Food Quality Testing Food Service Training

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SPS MACRO PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE SPS Technical Assistance Needs Are Highly Varied 30 20 10 0 Multi Sector Pathogens Regulatory Capacity Laboratory Management WTO Accession Databases Other Biotechnology Pesticides Policy Environment Residues Customs and Ports Risk Analysis

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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

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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

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In Conclusion…The U.S. Experience

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2.

3.

Development of a strong interagency process with support from above allows us to effectively implement our rights and obligations. Our regulatory agencies have worked hard to ensure that our measures are science based and we can back the measures with sufficient scientific data.

Daily and weekly communication among agencies has helped us to build a strong SPS program.

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Your comments are welcome

Thank You

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