The United States Experience Implementing the WTO SPS Agreement

Hangzhou, ChinaDecember 2008

Roseanne FreeseSenior WTO SPS Affairs OfficerUnited States SPS Enquiry Point

United States Department of AgricultureForeign Agricultural Service

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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.

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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

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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

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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

U.S. SPS ENQUIRY

POINT

U.S. SPSNATIONAL

NOTIFICATIONAUTHORITY

APHIS OVERSEAS

OFFICES

PRIVATESECTOR

APHISVETERINARY

SERVICES

APHISPLANT

PROTECT-ION AND

QUARANTINE

FAS

OVERSEAS

OFFICES

FDA

OVERSEAS

OFFICE

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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

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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. Strategies

3. 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 MEASURESWTO 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

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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:

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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

Animal and Plant Health Inspection

Service

EnvironmentalProtection

Agency

Food and DrugAdministration

Food Safety Inspection

Service

U.S. NNA Database Staff

U.S. NNA Document

Staff

Database staff add U.S. WTO notifications toWTO WorldNotifications Newsletter Every Week

Final copies sent back to agenciesfor their records

WTO Secretariat issuesOfficial notifications

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

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How U.S. Official Comments on Foreign SPS Measures Are Prepared and Submitted to Foreign Governments

AMS APHIS FDA FSIS EPA GIPSA DOCTTB

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 &TBTWorld News Report

SPS Document

Staff

FAS Policy Experts and Posts

Industry

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The United States Is Committed to WTO Compliance

050

100150200250300350

Total Number of U.S. WTO SPS Notifications

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

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Growth in the Number of Foreign SPS Measures Since Implementation of the WTO SPS

Agreement in 1996

0100200300400500600700800900

Total Number of Foreign WTO SPS Measures Reviewed bythe United States

The Volume of Measures Has Grown Tremendously – Requiring more coordination, more texts, more translations, and more

consultation

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Monitoring of Foreign SPS MeasuresRequires Immense Resources

0

20

40

60

80

100

120

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Nov20

2008Number of Foreign SPS Measures Commentedon by the United States

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

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U.S. ANIMAL HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE

SPS Technical Assistance Needs Are Highly Varied

0

10

20

30

40

50

60

70

80

Animal Disease Monitoringand Quarantine

Livestock and PoultryInspection

Meat Product Handling

HACCP

Dairy Safety

Aquatics Safety

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U.S. PLANT HEALTH PROJECTS DURING JUNE 1, 2006-MAY 31, 2008 BY TYPE

SPS Technical Assistance Needs Are Highly Varied

0

2

4

6

8

10

12

14

16

18

Plant Pests

Plant Health andInspectionCrop 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

0

5

10

Good Agricultural PracticesProcessed Food InspectionProcessed Food SafetyLabelingCodexCanning and Food Contact MaterialsFood Quality TestingFood 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

0

10

20

30

Multi Sector BiotechnologyPathogens PesticidesRegulatory Capacity Policy EnvironmentLaboratory Management ResiduesWTO Accession Customs and PortsDatabases Risk AnalysisOther

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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

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.

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Roseanne.freese@fas.usda.govYour comments are welcome！

Thank You！