# Presentation: 042672

## Aquaculture: A Need for Import Tolerances

**Kim R. Young **
**Deputy Director, Division of Compliance**
**Center for Veterinary Medicine**
**US Food & Drug Administration**

**Notes:**
Good morning.  My name is Kim Young.  I currently am the Deputy Director for the Division of Compliance within the Food and Drug Administration’s Center for Veterinary Medicine.  My move to CVM was just recent.  Last September I was the aquaculture specialist within the FDA’s Center for Food Safety and Applied Nutrition’s Office of Seafood. 

## 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

**Notes:**
What I will be presenting today is 1) the overview of global aquaculture production, 2) the countries which export aquaculture products to the United States, and 3) 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

**Notes:**
To begin, the definition of aquaculture as defined by the Food and Agriculture Organization (FAO) of the United Nations is: “the farming of aquatic organisms, including fish, mollusks [which are your oysters, clams, mussels, and scallops], crustaceans [your shrimp, crayfish and lobster], and aquatic plants.  Farming implies some form of intervention in the rearing process of enhance production, such as regular stocking, feeding, protection from predators,“  The definition continues by explaining that it does not matter whether the aquatic organisms are commercially or privately owned.

## 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

**Notes:**
In 1999, the most recent figures that I have,  32.9 million metric tonnes of aquaculture products were destined for direct human consumption, in other words this figure does not include ornamental fish nor aquatic plants.   In recent years, on a global basis, the aquaculture industry has been growing by approximately 9.2% per year.  Today, one in every 4 finfish consumed and one in every 3 shrimp consumed in the world has been farmed raised.  By the year 2007, FAO estimates that over 50% of the world’s food fish will come from aquaculture. 

## World Fisheries Production*

**Source: FAO**

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

**Million Tonnes**

**Notes:**
For a better perspective, this graph shows how the aquaculture industry, in green, continues to grow at a very fast rate, compared to the wild caught fish industry, in blue, which has basically flatten out over during the 1990s.   And again, FAO predicts that by the year 2007 that the green and blue columns will be equal. 

## 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

**Notes:**
The biggest producers of farmed raised seafood come from Asia which represents 90% of the global volume and approximately 82% of the dollar value of aquaculture products.  This continent’s main finfish production is carp which has yet to have a market in the U.S.  One concern we have is that a large majority of the aquaculture production, represented in the last two bullets, is in developing countries which do not have elaborate drug approval processes, if they have any at all.    

## 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

**Notes:**
The top twelve principal producing countries of aquaculture products are illustrated in the next two slides.  By far, the main producer of aquaculture products with 68.7 % of the world aquaculture production is the People’s Republic of China.  The other countries in descending order are India, Japan, The Philippines, Indonesia, South Korea,  

## 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

**Notes:**
Bangladesh, Thailand, Vietnam, North Korea, USA ranked at number 11, and Norway.

## 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

**Notes:**
OK, now that we have some insight on what is occurring globally in the aquaculture industry, how does that play in the U.S.  In the U.S., according to the National Fisheries Institute (NFI) which annually reports domestic fish consumption, the per capita consumption was 15.6 lbs. for the year 2000.  Based on NFI data and some conservative educated estimates on my part, approximately 32% of the fish we consume in the US is farmed raised and 24% of the fish we consume is actually imported farmed raised seafood.

## 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**
** ****0.28**

- Source: NFI

**Notes:**
Of the 15.6 lbs of seafood consumed for each person in the U.S., the predominate aquaculture species of shrimp, salmon and catfish are in the top five and represent 39% of the seafood consumed in the U.S.  I based my estimates of 32% of the fish we consume in the US is farmed raised and 24% of the fish we consume is actually imported farmed raised seafood on these three values alone.  From various reports I have heard, both aquaculturely raised shrimp and salmon, each, represents 75% of the total shrimp and salmon we consume.  Nearly 100% of the catfish we consume is aquaculture.  My figures do not consider any of the other farm-raised seafood we consume such as tilapia, trout, hybrid striped bass, and molluskin shellfish.   Our problem in determining exactly how much imported seafood is farm raised.  Currently, we, the US government do not have any standard methodology or ability to classify imported product as wild or aquaculture.  We can only go on what the import broker codes into FDA’s database.

## Major Aquaculture Products Exported to the U.S.

- Salmon
- Shrimp
- Mollusks
- Scallops
- Mussels
- Oysters
- Clams

- Tilapia
- Trout
- Striped Bass
- Frogs
- Catfish
- Crayfish

**Notes:**
The major aquaculture products currently exported to the US are listed here in order of largest number of  shipment sent.  Salmon and Shrimp represent over 90% of the over 44,000 aquaculture shipments sent to the US in one year.

## Countries Exporting Aquaculture Food Products to the U.S.

- Argentina
- Bangladesh
- Canada
- Costa Rica
- Ecuador
- Finland
- Greece
- Honduras
- India
- Israel
- Japan

- Australia
- Brazil
- Chile
- Denmark
- El Salvador
- France
- Guatemala
- Hong Kong
- Indonesia
- Italy
- Korea, Republic

- Austria
- Burma
- China, P.R.
- Dominican Rep.
- Faroe Islands
- Germany
- Guyana
- Iceland
- Ireland
- Jamaica
- Malaysia

**Notes:**
Over a one year period, 62 countries exported aquaculture products to the U.S.  The countries that I have highlighted in yellow have sent over 500 shipments to us during that one year period. 
Bangladesh, a low income country as described by 		FAO, exports shrimp, trout and striped 		bass to us.
Canada sends to us Salmon, molluskin shellfish, and 	trout
Chile sends to us salmon, trout and molluskin shellfish
Ecuador sends to us shrimp, salmon, trout and tilapia
Honduras sends to us shrimp and some salmon
India sends to us shrimp
Indonesia sends to us shrimp, tilapia and trout

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

- Mexico
- Nicaragua
- Oman
- Peru
- Saudi Arabia
- South Africa
- Sweden
- Tajikistan
- Trinidad &             	Tobago

- Netherlands
- Nigeria
- Pakistan
- Philippines
- Singapore
- Spain
- Switzerland
- Thailand
- United Kingdom
- Venezuela

- New Zealand
- Norway
- Panama
- Poland
- Solomon Island
- Sri Lanka
- Taiwan
- Togo
- Uruguay
- Vietnam

**Notes:**
Mexico sends to us shrimp, trout and salmon
Norway sends to us salmon 
The Philippines sends to us shrimp, trout, and molluskin shellfish
Thailand sends to us mainly shrimp with some trout and mollusks
United Kingdom biggest aquaculture export to us is salmon from Scotland.

From this list you can get a feel for the wide range of countries that export to us with various levels of government infrastucture to ensure safe seafood products.   

## Aquaculture Species Currently Not Exported to the U.S.

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

- Carp
- Eel
- Grouper
- Mackerel
- Sea Perch
- Yellowtail

**Notes:**
Import tolerances will not only allow the major seafood species that we import, such as salmon and shrimp, to be treated with drugs that have not gone through the full approval process by FDA but  also will allow approval of tolerances for drugs in seafood species that currently are not raised here in the U.S., at least at any significance.  Since these species are not being raised here in the US the drug companies have no economic incentive to purse FDA approval for a drug being dispensed in these species .  Examples of major farmed species that are not commonly marketed in the US are carp, which is widely grown in China;  Grouper which is grown in Hong Kong; and Cod which is major development in Norway.

## Examples of Drugs in Use in Foreign Aquaculture

- Acriflavine
- Amoxicillin
- Ampicillin
- Benzocaine
- Bicozamycin

- Chloramphenicol
- Colistin Sulfate
- Doxycycline
- Erythromycin
- Florfenicol

- Flumequine
- Fosfomycin
- Fruluphenicol
- Furanace
- Furazolidone

**Notes:**
On this slide and the next slide I have listed the names of 33 drugs that one Asian country has approved for use in aquaculture.  Those of you that are knowledgeable in pharmacology may question how a country could approve some of these drugs.  I have highlighted five drugs that, based on CVM’s present knowledge, would not be given an import tolerance.  The drugs are 
chlorampenicol, 
flumequine, 
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

**Notes:**
Oxolinic acid
Malachite Green

The good news is that this country currently exports only a few aquaculture shipments to the United States.

## Drugs Approved in US Aquaculture

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

**Notes:**
Currently, there are 6 drugs approved for aquaculture use in the US.
Chorionic gonadotropin, used a an aid in improving spawning function in brood finfish only
Formalin solution, may used on all finfish species and shrimp 
Tricaine methanesulfonate (MS-222), an anesthetic that can only be used on a few fish intended to be used for food.  This drug has a 21 day withdrawal time. 
Oxytetracycline, Does has a tolerance of 2.0 ppm but can only be used in salmon, trout, catfish and lobster. 
Sulfamerazine, can only be used in trout but this drug is currently not marketed.
Sufadimethoxine/ormetoprim combination does have a tolerance of 0.1 ppm but can only be used in salmon, trout, and catfish.

## 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

**Notes:**
The misuse of veterinary drugs in aquaculture is a concern to the Agency and is reflected in our seafood Hazard Analysis and Critical Control Point (HACCP) guidance to the industry.  In 1997, the Agency implemented the Seafood HACCP regulation which requires  all processors, both domestic and foreign, to develop a HACCP plan for all those hazards which are reasonably likely to occur.  The misuse of veterinary drugs in aquaculture is one such hazard which needs to be addressed in all firms that are required to implement a HACCP program.   
HACCP consists of seven principles which I have on this slide.  
Hazard: Unapproved veterinary drugs
CCP: receiving
CL: no traces of unapproved drugs
Monitor Proc: on farm review of records
CA:  destroy product and stop buying from farmer
Verif Proc.: random drug testing,  weekly review of records
Recordkeeping:  a record that shows that the incoming fish was confirmed as coming from a farm that has up-to-date records any all drug usage.

## 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

**Notes:**
Under the HACCP regulation, all importers have to ensure that the seafood products that they import have been processed under the same standards as required domestically.  This includes the foreign processor being required to document that the raw fish that they have received has not been treated with an FDA unapproved drug and that an FDA approved drug has been used properly.  The FDA does perform verification of foreign compliance with this regulation through foreign inspections at the processors and producers, inspections at the importer, and through product testing.  When the Agency finds non compliance of a foreign firm with our regulations, the products from the foreign firm can be placed under import alert 16-120 if the foreign firm has inadequate HACCP plan or implementation, or import alert 16-124, if the firm’s product is found to have a drug residue. 

## 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

**Notes:**
The Agency’s current drug testing program is testing for chloramphenicol in shrimp, flumequine in catfish and shrimp, malachite green in catfish, piromidic asid in shrimp, oxolinic acid in catfish, salmon and shrimp, and oxytetracycline in shrimp.  As more methods for determining drugs in aquacultured species are developed, they will be added to the testing program.  The Center for Veterinary Medicine currently has _____ drug determinative methods and various stages of development.  Current drug testing

## 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.

**Notes:**
To gather accurate information regarding the use of drugs used in aquaculture worldwide, the Center for Veterinary Medicine has engaged the services of a contractor to collect drug usage data from foreign countries that export to the United states.  The data includes information such as the types, amounts, and use patterns of drugs and chemicals used in a country’s aquaculture industry.  As the information in gathered, a human food safety risk assessment will be conducted.

## 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.

**Notes:**
Read slide

## 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

**Notes:**
Read Slide

## 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

**Notes:**
In summation, of the previous slides,

Read slides.

 That concludes my remarks today.  Thank you for listening.