“ 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
Regulators and Certification 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
1. Background: aquaculture demand and imports
U.S. Trade Seafood Trade Seafood, number one traded food in the world World Trade
As Capture declines or platues, Seafood is going from Supply and Demand to More Demand than Supply 250,000 200,000 150,000 100,000 50,000 0 Deficit of Seafood -50,000 -100,000 2005 2010 2015 2020 2025 2030 Demand - growing per caput consumption Aquaculture Capture Surplus/Deficit
Aquaculture Growth Demand 18.0 16.0 ) From g 14.0 (k capture ly 12.0 fisheries p p 50% From Aquaculture 10.0 u t s From 8.0 u p aquaculture a 6.0 c r 4.0 e P 2.0 0.0 0 5 0 5 0 5 0 5 0 5 0 5 0 5 7 7 8 8 9 9 0 0 1 1 2 2 3 3 9 9 9 9 9 9 0 0 0 0 0 0 0 0 1 1 1 1 1 1 2 2 2 2 2 2 2 2 When aquaculture production must double to meet the expected demand Whatever timeline, aquaculture is critical for the future Only Hunt and Gather the Sea for So Long
U.S., Like Most Developed Countries, Import The Vast Majority of their Seafood U.S. fourth- largest exporting country and second- largest importer. Source: Food and Water Watch, 2007
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 or chemicals • Use of growing water with pathogens and chemicals • Poor practices on farm; both during grow-out and post harvest
Again, these Working but are Farm or Not so Good Toilet Source Problems Residue in Poultry Waste Toilet over Water for ponds Ice Contaminated Drinking Water
Aquaculture Food Safety Unapproved Residues � 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.
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
Large Demand For Certification � 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
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
Brett.Koonse@fda.hhs.gov The End
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