Aquaculture: A Need for Import Tolerances

Kim R. Young Deputy Director, Division of

ComplianceCenter for Veterinary MedicineUS Food & Drug Administration

Presentation

• Overview of global aquaculture production

• Countries which export aquaculture products to the United States

• FDA’s concern of global veterinary drugs used in aquaculture

Aquaculture

Definition: “the farming of aquatic organisms, including fish, mollusks,

crustaceans, and aquatic plants. Farming implies some form of intervention in the rearing process to enhance production, such as regular stocking, feeding, protection from predators,

etc. … “

Source: FAO

Global Aquaculture Production

• 32.9 million tonnes (1999)

• Increasing at 9.2% per year

• One in 4 finfish from aquaculture

• One in 3 shrimp from aquaculture• Over 50% of food fish will come from

aquaculture in 2007

Source: FAO

World Fisheries Production*

0

10

20

30

40

50

60

70

1990 1992 1994 1996 1998 1999

Wild Caught Aquaculture

Source: FAO

* Wild Caught excludes non-human food production (e.g., fishmeal and oil) Aquaculture excludes plant production (e.g., kelp)

Mil

lion

Ton

nes

Asia and Aquaculture

• Asia produces around 90% of global volume (mainly carps)

• Equivalent to around 82% of value

• 87.1% by developing countries • 76.8% from Low-Income Food Deficit

Countries with per capita income below US$ 1,465.

Source: FAO

Global Aquaculture Production by Principal Producers, 1998

Rank Producer Production % of Global (millions tonnes) production

68.7

5.1

3.3

2.4

2.1

2.0

27.07

2.03

1.29

0.95

0.81

0.80

China

India

Japan

Philippines

Indonesia

South Korea

1

2

3

4

5

6

Source: FAO

Global Aquaculture Production by Principal Producers, 1998

Rank Producer Production % of Global (millions tonnes) production

7

8

9

10

11

12

Bangladesh

Thailand

Vietnam

North Korea

USA

Norway

0.58

0.57

0.54

0.48

0.45

0.41

1.5

1.4

1.4

1.2

1.1

1.0

Source: FAO

U.S. Seafood Consumption

• Per capital consumption 15.6 lbs. (2000)– Approx. 5 lbs aquaculture (32 %)

• Approx. 3.8 lbs imported aquaculture (24 %)

Source: NFI

U.S. Top Ten Consumption List

1 Tuna

2 Shrimp

3 Alaska Pollock

4 Salmon

5 Catfish

6 Cod

7 Clams

8 Crabs

9 Flatfish

10 Scallops

Lbs./person

3.60

3.20

1.69

1.60

1.23

0.77

0.49

0.46

0.43

0.28Source: NFI

Major Aquaculture Products Exported to the U.S.

• Salmon• Shrimp• Mollusks

– Scallops

– Mussels

– Oysters

– Clams

• Tilapia• Trout• Striped Bass• Frogs• Catfish• Crayfish

Countries Exporting Aquaculture Food Products to the U.S.

ArgentinaBangladeshCanadaCosta RicaEcuadorFinlandGreeceHondurasIndiaIsraelJapan

AustraliaBrazilChileDenmarkEl SalvadorFranceGuatemalaHong KongIndonesiaItalyKorea, Republic

AustriaBurmaChina, P.R.Dominican Rep.Faroe IslandsGermanyGuyanaIcelandIrelandJamaicaMalaysia

Countries Exporting Aquaculture Food Products to the U.S. (Continued)

MexicoNicaraguaOmanPeruSaudi ArabiaSouth AfricaSwedenTajikistanTrinidad & Tobago

NetherlandsNigeriaPakistanPhilippinesSingaporeSpainSwitzerlandThailandUnited KingdomVenezuela

New ZealandNorwayPanamaPolandSolomon IslandSri LankaTaiwanTogoUruguayVietnam

Aquaculture Species Currently Not Exported to the U.S.

• Amberjack• Cod• Flounder• Halibut• Red Sea Bream• Sweetfish

• Carp• Eel• Grouper• Mackerel• Sea Perch• Yellowtail

Examples of Drugs in Use in Foreign Aquaculture

Acriflavine

Amoxicillin

Ampicillin

Benzocaine

Bicozamycin

Chloramphenicol

Colistin Sulfate

Doxycycline

Erythromycin

Florfenicol

Flumequine

Fosfomycin

Fruluphenicol

Furanace

Furazolidone

Examples of Drugs in Use in Foreign Aquaculture (Continued)

Josamycin

Kanaymcin

Kitasamycin

Lincomycin

Malachite Green

Methyldihydro- testosterone

Methylene Blue

Miroxisacin

Nalidixic acid

Nitrofurantoin

Novobiocin

Oleandomycin

Oxolinic acid

Oxytetracycline

Nifurstyrenate

Spiramycin

Sulfonamides

Thiamphenicol

Drugs Approved in US Aquaculture

• Chorionic gonadotropin• Formalin solution• Tricaine methanesulfonate (MS-222)• Oxytetracycline• Sulfamerazine• Sufadimethoxine/ormetoprim combination

Aquaculture Safety

• Seafood HACCP– List Hazards

• Unapproved Veterinary Drugs

– List Critical Control Points– List Critical Limits– List Monitoring Procedures– List Corrective Actions– List Verification Procedures– Provide for Recordkeeping System

Aquaculture Safety- Enforcement -

• Inspections– Foreign Inspections of Processors and Producers– Review of HACCP plan at the importer– Drug testing

• Import Alerts– Inadequate HACCP plan/implementation– Drug residues

Aquaculture Safety- Enforcement - (Continued)

• Current drug testing– Chloramphenicol in Shrimp– Flumequine in Catfish & Shrimp– Malachite Green in Catfish– Piromidic Acid in Shrimp– Oxolinic Acid in Catfish, Salmon & Shrimp– Oxytetracycline in Shrimp

Database for Drugs and Chemicals used in Foreign Aquaculture

• Objectives:– create a database containing information on

drug and chemical use in foreign aquaculture, and

– perform a human food safety risk assessment for each drug and chemical listed in the database.

Database for Drugs and Chemicals used in Foreign Aquaculture (Continued)

• FDA will use the results of this project to:– prioritize the monitoring of drugs and

chemicals residues in the edible tissue of imported aquaculture products,

– prioritize the development of methods to be used in the monitoring program,

– provide a basis for promoting discussion with foreign countries regarding the hazard concerns identified by the risk assessment.

How to Encourage Import Tolerance Applications?

• Use Risk Assessments to Develop and Implement Risk Management=Residue Monitoring Program– Develop Residue Methods for High Priority

Residues– Efficiently Direct Monitoring of Imports for

Residues of Concern– Put Import Alerts in Effect for Countries where

Monitoring Shows Residues are Not Controlled– Publicize Monitoring Results

Summary

• FDA regulates both drugs for aquaculture & inspection for aquaculture food products

• HACCP on Imports and Foreign Inspection Equivalency Discussions Show Wide Disparity in Drugs Permitted to be Used

• Potentially hundreds of Import Tolerances are needed for aquaculture species, alone