Exporting Seafood to the Exporting Seafood to the USAUSA

Steven WilsonSteven WilsonChief Quality OfficerChief Quality Officer

USDC Seafood Inspection ProgramUSDC Seafood Inspection Program

USDA EPA

FDAMandatoryRegulatoryCompliance

NOAAVoluntary, Regulatory

Compliance plusproduct quality

inspection services

U.S. Food Safety U.S. Food Safety AgenciesAgencies

HHS USDC

OverviewOverview

• FederalFederal

• VoluntaryVoluntary

• Fee-for-ServiceFee-for-Service

• Domestic and OverseasDomestic and Overseas

ServicesServices• In-plant Inspection & CertificationIn-plant Inspection & Certification

– ContinuousContinuous– System EvaluationSystem Evaluation

• Lot Inspection & CertificationLot Inspection & Certification• Consultative ServicesConsultative Services

– HACCP Plan Development and ValidationHACCP Plan Development and Validation– Third Party VerificationsThird Party Verifications– TrainingTraining– Analytical testingAnalytical testing

Participants & Participants & BeneficiariesBeneficiaries

• HarvestersHarvesters• ProcessorsProcessors• DistributorsDistributors• Retailers Retailers • Food Service OperatorsFood Service Operators• Importers and ExportersImporters and Exporters• Foreign ProcessorsForeign Processors• Foreign GovernmentsForeign GovernmentsConsumersConsumers

Seafood ImportsSeafood Imports

• Over 85% of Seafood Products Consumed Over 85% of Seafood Products Consumed in U.S. are Importedin U.S. are Imported

• Numerous Species & Product FormsNumerous Species & Product Forms

• Originate from Countries with Wide-Originate from Countries with Wide-Ranging Infrastructure, Capabilities, & Ranging Infrastructure, Capabilities, & ControlsControls

StakeholdersStakeholders

• PublicPublic

• IndustryIndustry

• Legislative BodiesLegislative Bodies

• Government AgenciesGovernment Agencies

• Consumer Advocate GroupsConsumer Advocate Groups

DriversDrivers

• Buyer/Supplier RelationshipBuyer/Supplier Relationship

• Liability ConcernsLiability Concerns

• Media CoverageMedia Coverage

• Technically Savvy PublicTechnically Savvy Public

• Alternative Choices are AbundantAlternative Choices are Abundant

Recent LegislationRecent Legislation

• Public Health Security and Public Health Security and Bioterrorism Response Act of 2002 Bioterrorism Response Act of 2002 (Bioterrorism Act)(Bioterrorism Act)– Prior NoticePrior Notice– Registration of Firms Exporting to USARegistration of Firms Exporting to USA

• Farm Security and Rural Investment Farm Security and Rural Investment Act of 2002 (2002 Farm Bill)Act of 2002 (2002 Farm Bill)– Country of Origin Labeling (COOL)Country of Origin Labeling (COOL)

• 2008 Farm Bill2008 Farm Bill

Emerging Program Emerging Program RequirementsRequirements

• ISO 9001ISO 9001

• Customer Quality RequirementsCustomer Quality Requirements

• Food DefenseFood Defense

• ISO 22000/PAS 220ISO 22000/PAS 220

Specific Concerns of Specific Concerns of AquacultureAquaculture

• PollutantsPollutants

• Drug ResiduesDrug Residues

• Economic IntegrityEconomic Integrity

• Cost of ProductionCost of Production

• Vast Number of Raising AreasVast Number of Raising Areas

Supplier/Buyer Supplier/Buyer RelationshipRelationship

• Supply Chain ManagementSupply Chain Management

• Use of Approved SuppliersUse of Approved Suppliers

• Buyers Specification and VerificationBuyers Specification and Verification

• Importers Gaining ProminenceImporters Gaining Prominence

System EvaluationSystem Evaluation

• Process Analysis and ControlProcess Analysis and Control

• TraceabilityTraceability

• Documentation of ProceduresDocumentation of Procedures

• Recording ResultsRecording Results

End Item EvaluationEnd Item Evaluation

• High Comfort LevelHigh Comfort Level

• Economic Fraud ConcernsEconomic Fraud Concerns

• Liability ConcernsLiability Concerns

• Statistical Inference of ResultsStatistical Inference of Results

• Sensitivity of AnalysesSensitivity of Analyses

Agencies on Import to USAAgencies on Import to USA

• USFDAUSFDA

• USDA-FSISUSDA-FSIS

• USDA-AMSUSDA-AMS

• USDA-APHISUSDA-APHIS

• USDC-NMFSUSDC-NMFS

Animal and Plant HealthAnimal and Plant Health

• Animal Plant Health Inspection Animal Plant Health Inspection ServiceService

• National Marine Fisheries ServiceNational Marine Fisheries Service

Food Safety Inspection Food Safety Inspection ServiceService• MeatMeat

– BeefBeef– PorkPork– RabbitRabbit– HorseHorse– Etc.Etc.

• PoultryPoultry• EggsEggs

Reinspection at ImportReinspection at Import

• After product clears U.S. Customs product is After product clears U.S. Customs product is reinspectedreinspected

• Assignment is computerized and dependent upon Assignment is computerized and dependent upon compliance historycompliance history

• Type of inspection is determined: net weight Type of inspection is determined: net weight checks, condition of container, product defects, checks, condition of container, product defects, incubation of canned goods and laboratory analysisincubation of canned goods and laboratory analysis

• Additional random sampling for drug and pesticide Additional random sampling for drug and pesticide residuesresidues

• Shipment is usually released before results are Shipment is usually released before results are obtainedobtained

Agricultural Marketing Agricultural Marketing ServiceService

• FruitsFruits

• VegetablesVegetables

• DairyDairy

• TobaccoTobacco

• CottonCotton

Market OrdersMarket Orders

• Must meet the same or comparable Must meet the same or comparable grade, size, quality and maturity grade, size, quality and maturity requirementsrequirements

• Avacados, dates, hazelnuts, grapefruit, Avacados, dates, hazelnuts, grapefruit, table grapes, kiwifruit, olives, onions, table grapes, kiwifruit, olives, onions, oranges, Irish potatoes, plums, prunes oranges, Irish potatoes, plums, prunes raisins, tomatoes, walnutsraisins, tomatoes, walnuts

• Products checked at border posts by Products checked at border posts by U.S. CustomsU.S. Customs

U.S. Food and Drug U.S. Food and Drug AdministrationAdministration

• Responsible for All Foods except Responsible for All Foods except meat and poultrymeat and poultry

• Also responsible for various other Also responsible for various other products (toys, blood, medical products (toys, blood, medical devices, pharmaceuticals, etc.)devices, pharmaceuticals, etc.)

Snapshot of Seafood Laws and Snapshot of Seafood Laws and Regulations (FD&C Act)Regulations (FD&C Act)• 402 a(1) Food Contains Poisonous or 402 a(1) Food Contains Poisonous or

Deleterious SubstanceDeleterious Substance• 402 a(2) Food Contains Added Poisonous 402 a(2) Food Contains Added Poisonous

or Deleterious Substanceor Deleterious Substance• 402 a(3) Food Contains Filthy, Putrid, or 402 a(3) Food Contains Filthy, Putrid, or

Decomposed SubstanceDecomposed Substance• 402 a(4) Food Prepared, Packed or Held 402 a(4) Food Prepared, Packed or Held

Under Insanitary Conditions Whereby it Under Insanitary Conditions Whereby it May be Contaminated with Filth or May be Contaminated with Filth or Whereby it May have been Rendered Whereby it May have been Rendered Injurious to HealthInjurious to Health

Snapshot of Seafood Laws and Snapshot of Seafood Laws and RegulationsRegulations

• GMP Regulation (21 CFR 110)GMP Regulation (21 CFR 110)

• Seafood HACCP Regulation (21 CFR Seafood HACCP Regulation (21 CFR 123)123)

• Low Acid Canned Food Regulation Low Acid Canned Food Regulation (21 CFR 113)(21 CFR 113)

• Guidance (e.g., Fish and Fishery Guidance (e.g., Fish and Fishery Products Hazard Guide)Products Hazard Guide)

Requirements for Imported Requirements for Imported SeafoodSeafood

• Must appear to meet the requirements Must appear to meet the requirements of the FD&C Actof the FD&C Act

• Produced in compliance with the Produced in compliance with the Seafood HACCP regulation or be from a Seafood HACCP regulation or be from a country with an MOU or similar country with an MOU or similar agreementagreement

• Importer must show affirmative stepsImporter must show affirmative steps• Importer of record must have product Importer of record must have product

specifications ensuring compliancespecifications ensuring compliance

Types of DetentionTypes of Detention

• Detention of an Individual Entry Detention of an Individual Entry (based on Sample Collection or (based on Sample Collection or Physical Examination)Physical Examination)

• Detention Without Physical Detention Without Physical ExaminationExamination

Detention CriteriaDetention Criteria

• Recommendation of FDA After a Recommendation of FDA After a Regulatory VisitRegulatory Visit

• Recommendation of a Foreign Recommendation of a Foreign Competent AuthorityCompetent Authority

• Shipment Appears ViolativeShipment Appears Violative

Violative SampleViolative Sample

• Product may have adverse health Product may have adverse health consequencesconsequences

• Product contains actionable levels of Product contains actionable levels of pesticides, aflatoxin, or chemical pesticides, aflatoxin, or chemical contaminantscontaminants

Violative SampleViolative Sample

• Not in compliance with low acid Not in compliance with low acid canned food regulationscanned food regulations

• Contains unapproved or misused Contains unapproved or misused ingredients or additivesingredients or additives

• Not in compliance with nutritional Not in compliance with nutritional labeling education act (Retail labeling education act (Retail packages)packages)

Procedures for Individual Procedures for Individual DetentionsDetentions

• Appears violative (damage packages, Appears violative (damage packages, thawing, etc.)thawing, etc.)

• FDA samples and analyzes lotFDA samples and analyzes lot

• Lot released if no violationLot released if no violation

• Non-violation does not affect future Non-violation does not affect future shipmentshipment

• Violative product not allowed entryViolative product not allowed entry

Detention without Physical Detention without Physical ExaminationExamination

• A Shipment has the appearance of A Shipment has the appearance of adulteration under the FD&C Actadulteration under the FD&C Act

• Based on an Import Alert issued to Based on an Import Alert issued to address a perceived problemaddress a perceived problem

• Firms, Countries, and Regions may Firms, Countries, and Regions may be subject to DWPEbe subject to DWPE

How to Get Off DWPEHow to Get Off DWPE

• Firms must have 5 compliant shipments in Firms must have 5 compliant shipments in a six month perioda six month period

• At least one shipment audited by FDA to At least one shipment audited by FDA to ensure analytical validityensure analytical validity

• Shipment must represent usual products Shipment must represent usual products and different production runsand different production runs

• Countries and Regions must have 12 Countries and Regions must have 12 compliant shipmentscompliant shipments

• Apply to the Division of Import Operation Apply to the Division of Import Operation PolicyPolicy

Removal From DWPERemoval From DWPE

• FDA must be assured that firms are FDA must be assured that firms are compliant over a reasonable period to compliant over a reasonable period to remove from DWPEremove from DWPE

• FDA needs adequate product for samplingFDA needs adequate product for sampling

• FDA may request other documentationFDA may request other documentation

• Shipment must be compliant to all other Shipment must be compliant to all other provisions of US laws and regulationsprovisions of US laws and regulations

• FDA may require an establishment FDA may require an establishment inspectioninspection

Bioterrorism Act Bioterrorism Act RequirementsRequirements• All Food Firms must be registeredAll Food Firms must be registered

– Online at Online at http://www.cfsan.fda.gov/~furls/ovffreg.html

– By mail or fax with Form 3537 available at By mail or fax with Form 3537 available at http://www.cfsan.fda.gov/~furls/papercd.html#forms

– Address: U.S. Food and Drug Administration, Address: U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD HFS-681, 5600 Fishers Lane, Rockville, MD 2085720857

– Fax:Fax: (301) 210-0247(301) 210-0247

Bioterrorism Act Bioterrorism Act RequirementsRequirements• Prior Notice ContactPrior Notice Contact

– http://www.cfsan.fda.gov/~pn/pnoview.htmlhttp://www.cfsan.fda.gov/~pn/pnoview.html

• Prior Notice of a Food Shipment must be Prior Notice of a Food Shipment must be submitted:submitted:– No more than 5 days before arrival, except for No more than 5 days before arrival, except for

food arriving by international mail, and no less food arriving by international mail, and no less thanthan

– 2 hours before arrival—land by road2 hours before arrival—land by road– 4 hours before arrival—land by rail4 hours before arrival—land by rail– 4 hours before arrival—air4 hours before arrival—air– 8 hours before arrival--water8 hours before arrival--water

Approved Aquaculture Approved Aquaculture DrugsDrugs

• Chorionic GonadotropinChorionic Gonadotropin

• Oxytetracycline monoalkyl trimethyl Oxytetracycline monoalkyl trimethyl ammoniumammonium

• Sulfadimethoxine ormetoprimSulfadimethoxine ormetoprim

• Tricaine methanesulfonateTricaine methanesulfonate

• FormalinFormalin

• SulfamerazineSulfamerazine

Regulatory Process for Serious Regulatory Process for Serious Violations—Warning LetterViolations—Warning Letter

• If a Warning Letter or Untitled Letter is If a Warning Letter or Untitled Letter is issued, there will be a follow-up issued, there will be a follow-up investigationinvestigation

• If the same or similar problem is found If the same or similar problem is found then the process is repeatedthen the process is repeated

• May result in a court injunction or product May result in a court injunction or product seizureseizure

• Foreign processor may be placed on Foreign processor may be placed on Detention Without Physical ExaminationDetention Without Physical Examination

Avoiding Regulatory Avoiding Regulatory ProblemsProblems• Make corrections as soon as possible! Make corrections as soon as possible!

Communicate to FDA in writingCommunicate to FDA in writing– Domestic firms need to submit corrective action Domestic firms need to submit corrective action

before the inspection is classifiedbefore the inspection is classified– Foreign firms need to submit corrections to Foreign firms need to submit corrections to

Investigator before they leave the countryInvestigator before they leave the country– If the firm cannot agree with the inspection If the firm cannot agree with the inspection

results, the industry may petition the FDA results, the industry may petition the FDA regarding the scientific validity of HACCP controlsregarding the scientific validity of HACCP controls

– Enforcement may be held in abeyance until a Enforcement may be held in abeyance until a review is madereview is made

Consequences of a Regulatory Consequences of a Regulatory ActionAction

• Disruption of Production—Long TermDisruption of Production—Long Term

• Inability to move product in commerceInability to move product in commerce

• More frequent inspectionsMore frequent inspections

• Warning Letters are published.Warning Letters are published.

• DWPE for foreign firms may impose DWPE for foreign firms may impose burden of illustrating product is safe burden of illustrating product is safe resulting in costly analytical testingresulting in costly analytical testing

Country of Origin LabelingCountry of Origin Labeling

• Mechanism of TraceabilityMechanism of Traceability

• Applies to Retail EstablishmentsApplies to Retail Establishments

• Only certain size establishments Only certain size establishments must complymust comply

• Aquacultured Fish vs Wild CaughtAquacultured Fish vs Wild Caught

ConclusionsConclusions

• Regulatory Actions Can Disrupt BusinessRegulatory Actions Can Disrupt Business• FDA Desires Compliance through Cooperative FDA Desires Compliance through Cooperative

InterchangeInterchange• Positive steps can be taken by industryPositive steps can be taken by industry• FDA will accommodate good faith disagreementsFDA will accommodate good faith disagreements• Stronger Focus on Food ChainStronger Focus on Food Chain• Importers are Held ResponsibleImporters are Held Responsible• Quality is a Driver for ChangeQuality is a Driver for Change• Government/Industry PartnershipsGovernment/Industry Partnerships• Quality Management Influence on PolicyQuality Management Influence on Policy

Thank Thank you!you!