Regulators and Certification Todays Talk: 1. Background : - - PowerPoint PPT Presentation

“Regulators and Aquaculture

Certification…Can We Use It?”

Brett Koonse

U.S. Food and Drug Administration

FAO Aquaculture Certification Workshop Silver Spring, Maryland May 29-30, 2008 My e-card:

Brett.Koonse@fda.hhs.gov

Today’s Talk:

• 1. Background: aquaculture

demand and imports

• 2. Problem: Aquaculture

Food Safety concerns; real/perceived

• 3. Certification: One Potential

Option for more food safety assurance

Regulators and Certification

• 1. Background: aquaculture

demand and imports

Seafood Trade

Seafood, number

• ne traded food

in the world

World Trade U.S. Trade

As Capture declines or platues, Seafood is going from Supply and Demand to More Demand than Supply

• 100,000
• 50,000

50,000 100,000 150,000 200,000 250,000 2005 2010 2015 2020 2025 2030 Demand - growing per caput consumption Aquaculture Capture Surplus/Deficit

Deficit of Seafood

0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 1 9 7 1 9 7 5 1 9 8 1 9 8 5 1 9 9 1 9 9 5 2 2 5 2 1 2 1 5 2 2 2 2 5 2 3 2 3 5 P e r c a p u t s u p p ly (k g )

From capture fisheries From aquaculture

Aquaculture Growth Demand 50% From Aquaculture Only Hunt and Gather the Sea for So Long

When aquaculture production must double to meet the expected demand

Whatever timeline, aquaculture is critical for the future

Source: Food and Water Watch, 2007

U.S., Like Most Developed Countries, Import The Vast Majority of their Seafood U.S. fourth- largest exporting country and second- largest importer.

* * * *

Consumption of Aquacultured products increasing

Considering demand deficit and consumption, If consume seafood like recommended for health……

Seafood Consumption Recommendation:

U.S. FDA regulates over $1 trillion worth of products…Very Busy

• 25 cents of every dollar spent annually by American

consumers is on FDA regulated products.

• Foods, drugs, vaccines, medical devices, animal

foods and drugs, blood, tissues, biotechnology, radiation-emitting products, dietary supplements, cell therapies, and much more.

Dramatic Increase in All Food/Ingredient Imports – More burden on Regulators About 25,000 shipments of FDA-regulated foods arrive daily; from more than 100 countries.

• 1. Background: aquaculture demand and imports
• 2. Food Safety Concerns with

Aquaculture Products, Real and Perceived

Aquaculture Food Safety Concerns

Down on the Farm

Most Regulatory Programs not designed for that

• Using unapproved, drugs
• r chemicals
• Use of growing water

with pathogens and chemicals

• Poor practices on farm; both

during grow-out and post harvest

Again, these are Farm or Source Problems

Ice Contaminated

Toilet over Water for ponds Drinking Water Working but Not so Good Toilet

Residue in Poultry Waste

Aquaculture Food Safety

A 2003 study found on average, 13

different chemical and biological products used in each shrimp pond

The risk of exposing consumers to

suspected carcinogens (e.g., malachite green).

The risk of antibiotics that are harmful at

very low levels to (e.g., aplastic anemia and chloramphenicol)

Increasing antimicrobial resistance in

foodborne pathogens which may be transferred to humans.

Unapproved Residues

And We Do Find Problems

In a one year period, U.S. FDA detected unapproved residues in seafood from:

• 22% of the samples FDA checked from one

country

• 21%
• 17%
• 11%

And historically around 10% of the samples collected for shrimp have tested positive for Salmonella.

Food Refused Entry is both a Health and Trade Issue

Source: New York Times

Government Perception

Food Safety Perception Problem

• 1. Background: aquaculture demand and imports
• 2. Food Safety Concerns with

Aquaculture Products, Real and Perceived

• 3. Certification: One Potential Option for

more food safety assurance… plus benefits

Aquaculture demand + Problems = Rise of Market Driven Certifications

• Consumers continually

say food safety is most important issue… next to price

• To show buyers and

consumers certain standards are met (safety, enviro, social)

• Often standards exceed

what government can do

Certified

Certified

Wal-Mart Becomes First Nationwide

U.S. Grocer to Adopt Global Food Safety Initiative Standards

Worlds largest retail store requires

suppliers to comply with standards above FDA or USDA requirements by end of 2008

Large Demand For Certification

With all the Interest in Import Safety in the Last Year

The U.S. President formed a Interagency Working

Group on Import Safety

In November 2007, the Working Group released

an ``Action Plan for Import Safety”

Recommendation 2 of the Action Plan is to

``verify compliance of foreign producers with United States safety and security standards through certification.''

And, With all the third party certifications already going on:

The U.S. FDA wants to learn more about

them

Wants to see if qualified third party

certification could be used to help ensure that food products are safe, secure, and meet FDA requirements

On April 2, 2008, U.S. FDA Issued an Official Notice asking for Public Comments on Third Party Food Certification

[Docket No. FDA-2008-N-0183]

In General, What are Some Questions about a Voluntary Food Safety Certification Program

for Aquaculture Products

What are the appropriate Standards

and Controls at farms, processors, feed manufactures, etc

Should only production country

laws be complied with or receiving also

What Records must be

kept/accessible to regulators

Should traceability be included How Transparent should a program

be

In General, What are Some Questions about a Voluntary Food Safety Certification Program

for Aquaculture Products

(Continued)

Should there be a tiered program

(processors only, plus farms and hatcheries; HACCP and more)

How does a program assure No

Conflict of Interests (certifier, accreditor, processor, etc)

What would a regulator Audit of the

cert program look like

What would be a creditable Lab

Testing Verification program

In General, What are Some Questions about a Voluntary Food Safety Certification Program

for Aquaculture Products

(Continued)

How is success of the cert

program measured and verified

What are the existing barriers

to the use of certification programs

What are the potential

incentives for participation in certification programs (government, market, etc.)

Voluntary Third Party Certification, What's in it For Me? Possibly….

Regulator:

It could allow better use and focus of resources

and efforts

More products Covered Preventative…. “ Prevention not Detention”

Food Processors, Importers, Exporters:

Perhaps quicker and easier entries into markets Less trade disruption; “ Prevention not Detention” Other incentives, motivations for participation?

Voluntary Third Party Certification, What's in it For Me? Possibly….

(cont.)

For Farmers:

Level playing field…for everyone They would know the requirements better Better access to better buyers Higher price Other incentives?

For Consumers:

Better, safer food More Information and Choices about the food

Certification as a Requirement Now

Part of a recent U.S. FDA Import Alert for

aquaculture seafood with unapproved residues is a “certification” requirement for processors.

They must be “Certified” that they

meet FDA regulations.

Third Party Certification Issues

More Collaboration, reciprocity Clearer focus, does it need to be

all things to all people?

Basic agreed to standards Training, especially small farms Education/awareness for Consumers,

restaurants, regulators

Level playing field Credible, means something Measurable Success Simplify, simplify, simplify

Summary:

• More and more seafood comes from aquaculture
• Eating more of it and it’s good for us
• There are some public health issues with aqua
• Variety of certification programs out there
• Some require public health standards that

exceed government requirements

• U.S. FDA is considering taking advantage of

credible third party certifications

• What are the possible incentives for participating?
• The certifications must be credible
• Educate; make certification mean something

The End

Brett.Koonse@fda.hhs.gov