FSIS Enforcement of Animal Drug Tolerances in Imported Meat and Poultry Products Food Safety and Inspection Service Veterinary Medicine Advisory Committee

FSIS Enforcement of FSIS Enforcement of Animal Drug Tolerances in Animal Drug Tolerances in Imported Meat and Poultry Imported Meat and Poultry

ProductsProducts

Food Safety and Inspection ServiceFood Safety and Inspection Service

Veterinary Medicine Advisory Committee

January 22, 2002

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USDA - Food Safety and Inspection Service

INTRODUCTIONINTRODUCTION

John C. PruchaD.V.M., M.S., M.P.H., D.A.C.V.P.M.

Assistant Deputy Administrator

Food Safety and Inspection Service

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IMPORT IMPORT REREINSPECTIONINSPECTION

Foreign Inspection

Service

Inspected Passed Certified


RE-inspected Passed Released

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EXPORTING COUNTRIESEXPORTING COUNTRIES

Argentina

Australia

Austria

Belgium

Brazil

Canada

Costa Rica

Croatia

Denmark

Finland

France

Germany

Honduras

Hong Kong

Hungary

Iceland

Ireland

Israel

Italy

Japan

Mexico

Netherlands

New Zealand

Nicaragua

Poland

Spain

Sweden

Switzerland

United Kingdom

Uruguay

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EXPORTING COUNTRIESEXPORTING COUNTRIES

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EQUIVALENCEEQUIVALENCE

Equivalent inspection SYSTEM Not an establishment-based decision Reliance on foreign Competent

Authority to certify establishments for export to the United States

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EQUIVALENCEEQUIVALENCE

Trust . . .

But Verify

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Document Analysis

On-siteAudit

Port-of-EntryReinspection

EQUIVALENCETRIAD


DOCUMENT ANALYSISDOCUMENT ANALYSIS

Full-system analysis initially Animal husbandry practices Government residue control program Focused on sanitary measures later

“As needed event”

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ON-SITE AUDITON-SITE AUDIT

Full-system audit initially Farm and feedlot visits Veterinary drug use Laboratory capabilities Focused on key elements later

“An annual event” 10


PORT-OF-ENTRYPORT-OF-ENTRYREINSPECTIONREINSPECTION

Conducted every day Every shipment Residue sampling Ports-of-entry around the U.S.

“A daily event”11



Billions of PoundsReinspected

Each Year

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Types of Inspection Shipping documents Container, packaging, labeling Organoleptic product reinspection Microbial sampling, lab analysis Formulation sampling, lab analysis Residue sampling, lab analysis

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PORT-OF-ENTRY PORT-OF-ENTRY RESIDUE SAMPLINGRESIDUE SAMPLING

Veterinary drugs Pesticides Environmental contaminants

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VETERINARY DRUGSVETERINARY DRUGS

FSIS: Draws samples at import

reinspection ports-of-entry Analyzes samples for marker

residues Takes action if residue tolerance

established by FDA is exceeded

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RESIDUE ENFORCEMENT RESIDUE ENFORCEMENT REGULATIONREGULATION

Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by [FDA], unless otherwise determined by the [FSIS] Administrator and listed herein. (9 CFR 318.20)

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RESIDUE ENFORCEMENT RESIDUE ENFORCEMENT POLICYPOLICY

If the residue is from a veterinary drug that is not approved by FDA for use

in the United States, FSIS would consider its tolerance to be:

zero

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FSIS enforces the zero tolerance policy at U.S. ports-of-entry for

imported meat and poultry products

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FSIS enforcement includes:

Refused entry Recall Destruction of adulterated product

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National Residue Program (NRP)National Residue Program (NRP)

Enforce U.S. laws and regulations Consumer confidence Deter misuse Assess and communicate human

exposure Verify HACCP systems

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Components

Monitoring Plan Special Projects Surveillance Enforcement Testing Import Residue Plan

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Resource Allocations in Year 2000

Domestic samples: 84% (40,250)

Imported samples: 16% (7,395)

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NRP Planning Phases

Phase I: Identify and rank compounds

Phase II: Select compounds

Phase III: Identify product classes

Phase IV: Allocate sampling resources

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Surveillance Advisory Team

USDA (FSIS, AMS, APHIS, ARS) FDA (CVM, CFSAN) EPA CDC

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NRP Planning Phases





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IMPORT IMPORT REREINSPECTIONINSPECTION

Foreign Inspection

Service

Inspected Passed Certified


RE-inspected Passed Released

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NRP Planning Phases





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NRP Planning Phases





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National Residue Program (NRP)National Residue Program (NRP)Import Residue PlanImport Residue Plan

COUNTRY

PRODUCT

COMPOUND

NO. SAMPLES

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COUNTRY

30 countries in the 2000 plan Active importers

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PRODUCT

Classes of product per country As few as one As many as seventeen

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PRODUCT Fresh Beef= 61% Fresh Pork= 19% Other Fresh= 05%

______

85% Fresh Product

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COMPOUND

Same as the domestic plan in 2000 Not included are drugs used legally

in other countries but neither approved nor banned in the U.S.

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NUMBER OF SAMPLES

Allocated by formula As few as 8 annually per compound,

per product class, per country As many as 220

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Equivalent

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ProductsProducts


Dr. John C. Prucha

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ProductsProducts


Dr. John C. Prucha

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Documents

FSIS Enforcement of Animal Drug Tolerances in Imported Meat and Poultry Products Food Safety and Inspection Service Veterinary Medicine Advisory Committee