Exporting Seafood to the USA Steven Wilson Chief Quality Officer USDC Seafood Inspection Program - PowerPoint PPT Presentation

1 / 41
About This Presentation
Title:

Exporting Seafood to the USA Steven Wilson Chief Quality Officer USDC Seafood Inspection Program

Description:

Exporting Seafood to the USA Steven Wilson Chief Quality Officer USDC Seafood Inspection Program Bioterrorism Act Requirements Prior Notice Contact http://www.cfsan ... – PowerPoint PPT presentation

Number of Views:100
Avg rating:3.0/5.0
Slides: 42
Provided by: globefish8
Learn more at: http://www.globefish.org
Category:

less

Transcript and Presenter's Notes

Title: Exporting Seafood to the USA Steven Wilson Chief Quality Officer USDC Seafood Inspection Program


1
Exporting Seafood to the USASteven WilsonChief
Quality OfficerUSDC Seafood Inspection Program
2
U.S. Food Safety Agencies
EPA
HHS
USDA
USDC
NOAA Voluntary, Regulatory Compliance
plus product quality inspection services
FDA Mandatory Regulatory Compliance
3
Overview
  • Federal
  • Voluntary
  • Fee-for-Service
  • Domestic and Overseas

4
Services
  • In-plant Inspection Certification
  • Continuous
  • System Evaluation
  • Lot Inspection Certification
  • Consultative Services
  • HACCP Plan Development and Validation
  • Third Party Verifications
  • Training
  • Analytical testing

5
Participants Beneficiaries
  • Harvesters
  • Processors
  • Distributors
  • Retailers
  • Food Service Operators
  • Importers and Exporters
  • Foreign Processors
  • Foreign Governments
  • Consumers

6
Seafood Imports
  • Over 85 of Seafood Products Consumed in U.S. are
    Imported
  • Numerous Species Product Forms
  • Originate from Countries with Wide-Ranging
    Infrastructure, Capabilities, Controls

7
Stakeholders
  • Public
  • Industry
  • Legislative Bodies
  • Government Agencies
  • Consumer Advocate Groups

8
Drivers
  • Buyer/Supplier Relationship
  • Liability Concerns
  • Media Coverage
  • Technically Savvy Public
  • Alternative Choices are Abundant

9
Recent Legislation
  • Public Health Security and Bioterrorism Response
    Act of 2002 (Bioterrorism Act)
  • Prior Notice
  • Registration of Firms Exporting to USA
  • Farm Security and Rural Investment Act of 2002
    (2002 Farm Bill)
  • Country of Origin Labeling (COOL)
  • 2008 Farm Bill

10
Emerging Program Requirements
  • ISO 9001
  • Customer Quality Requirements
  • Food Defense
  • ISO 22000/PAS 220

11
Specific Concerns of Aquaculture
  • Pollutants
  • Drug Residues
  • Economic Integrity
  • Cost of Production
  • Vast Number of Raising Areas

12
Supplier/Buyer Relationship
  • Supply Chain Management
  • Use of Approved Suppliers
  • Buyers Specification and Verification
  • Importers Gaining Prominence

13
System Evaluation
  • Process Analysis and Control
  • Traceability
  • Documentation of Procedures
  • Recording Results

14
End Item Evaluation
  • High Comfort Level
  • Economic Fraud Concerns
  • Liability Concerns
  • Statistical Inference of Results
  • Sensitivity of Analyses

15
Agencies on Import to USA
  • USFDA
  • USDA-FSIS
  • USDA-AMS
  • USDA-APHIS
  • USDC-NMFS

16
Animal and Plant Health
  • Animal Plant Health Inspection Service
  • National Marine Fisheries Service

17
Food Safety Inspection Service
  • Meat
  • Beef
  • Pork
  • Rabbit
  • Horse
  • Etc.
  • Poultry
  • Eggs

18
Reinspection at Import
  • After product clears U.S. Customs product is
    reinspected
  • Assignment is computerized and dependent upon
    compliance history
  • Type of inspection is determined net weight
    checks, condition of container, product defects,
    incubation of canned goods and laboratory
    analysis
  • Additional random sampling for drug and pesticide
    residues
  • Shipment is usually released before results are
    obtained

19
Agricultural Marketing Service
  • Fruits
  • Vegetables
  • Dairy
  • Tobacco
  • Cotton

20
Market Orders
  • Must meet the same or comparable grade, size,
    quality and maturity requirements
  • Avacados, dates, hazelnuts, grapefruit, table
    grapes, kiwifruit, olives, onions, oranges, Irish
    potatoes, plums, prunes raisins, tomatoes,
    walnuts
  • Products checked at border posts by U.S. Customs

21
U.S. Food and Drug Administration
  • Responsible for All Foods except meat and poultry
  • Also responsible for various other products
    (toys, blood, medical devices, pharmaceuticals,
    etc.)

22
Snapshot of Seafood Laws and Regulations (FDC
Act)
  • 402 a(1) Food Contains Poisonous or Deleterious
    Substance
  • 402 a(2) Food Contains Added Poisonous or
    Deleterious Substance
  • 402 a(3) Food Contains Filthy, Putrid, or
    Decomposed Substance
  • 402 a(4) Food Prepared, Packed or Held Under
    Insanitary Conditions Whereby it May be
    Contaminated with Filth or Whereby it May have
    been Rendered Injurious to Health

23
Snapshot of Seafood Laws and Regulations
  • GMP Regulation (21 CFR 110)
  • Seafood HACCP Regulation (21 CFR 123)
  • Low Acid Canned Food Regulation (21 CFR 113)
  • Guidance (e.g., Fish and Fishery Products Hazard
    Guide)

24
Requirements for Imported Seafood
  • Must appear to meet the requirements of the FDC
    Act
  • Produced in compliance with the Seafood HACCP
    regulation or be from a country with an MOU or
    similar agreement
  • Importer must show affirmative steps
  • Importer of record must have product
    specifications ensuring compliance

25
Types of Detention
  • Detention of an Individual Entry (based on Sample
    Collection or Physical Examination)
  • Detention Without Physical Examination

26
Detention Criteria
  • Recommendation of FDA After a Regulatory Visit
  • Recommendation of a Foreign Competent Authority
  • Shipment Appears Violative

27
Violative Sample
  • Product may have adverse health consequences
  • Product contains actionable levels of pesticides,
    aflatoxin, or chemical contaminants

28
Violative Sample
  • Not in compliance with low acid canned food
    regulations
  • Contains unapproved or misused ingredients or
    additives
  • Not in compliance with nutritional labeling
    education act (Retail packages)

29
Procedures for Individual Detentions
  • Appears violative (damage packages, thawing,
    etc.)
  • FDA samples and analyzes lot
  • Lot released if no violation
  • Non-violation does not affect future shipment
  • Violative product not allowed entry

30
Detention without Physical Examination
  • A Shipment has the appearance of adulteration
    under the FDC Act
  • Based on an Import Alert issued to address a
    perceived problem
  • Firms, Countries, and Regions may be subject to
    DWPE

31
How to Get Off DWPE
  • Firms must have 5 compliant shipments in a six
    month period
  • At least one shipment audited by FDA to ensure
    analytical validity
  • Shipment must represent usual products and
    different production runs
  • Countries and Regions must have 12 compliant
    shipments
  • Apply to the Division of Import Operation Policy

32
Removal From DWPE
  • FDA must be assured that firms are compliant over
    a reasonable period to remove from DWPE
  • FDA needs adequate product for sampling
  • FDA may request other documentation
  • Shipment must be compliant to all other
    provisions of US laws and regulations
  • FDA may require an establishment inspection

33
Bioterrorism Act Requirements
  • All Food Firms must be registered
  • Online at http//www.cfsan.fda.gov/furls/ovffreg.
    html
  • By mail or fax with Form 3537 available at
    http//www.cfsan.fda.gov/furls/papercd.htmlforms
  • Address U.S. Food and Drug Administration,
    HFS-681, 5600 Fishers Lane, Rockville, MD 20857
  • Fax (301) 210-0247

34
Bioterrorism Act Requirements
  • Prior Notice Contact
  • http//www.cfsan.fda.gov/pn/pnoview.html
  • Prior Notice of a Food Shipment must be
    submitted
  • No more than 5 days before arrival, except for
    food arriving by international mail, and no less
    than
  • 2 hours before arrivalland by road
  • 4 hours before arrivalland by rail
  • 4 hours before arrivalair
  • 8 hours before arrival--water

35
Approved Aquaculture Drugs
  • Chorionic Gonadotropin
  • Oxytetracycline monoalkyl trimethyl ammonium
  • Sulfadimethoxine ormetoprim
  • Tricaine methanesulfonate
  • Formalin
  • Sulfamerazine

36
Regulatory Process for Serious ViolationsWarning
Letter
  • If a Warning Letter or Untitled Letter is issued,
    there will be a follow-up investigation
  • If the same or similar problem is found then the
    process is repeated
  • May result in a court injunction or product
    seizure
  • Foreign processor may be placed on Detention
    Without Physical Examination

37
Avoiding Regulatory Problems
  • Make corrections as soon as possible!
    Communicate to FDA in writing
  • Domestic firms need to submit corrective action
    before the inspection is classified
  • Foreign firms need to submit corrections to
    Investigator before they leave the country
  • If the firm cannot agree with the inspection
    results, the industry may petition the FDA
    regarding the scientific validity of HACCP
    controls
  • Enforcement may be held in abeyance until a
    review is made

38
Consequences of a Regulatory Action
  • Disruption of ProductionLong Term
  • Inability to move product in commerce
  • More frequent inspections
  • Warning Letters are published.
  • DWPE for foreign firms may impose burden of
    illustrating product is safe resulting in costly
    analytical testing

39
Country of Origin Labeling
  • Mechanism of Traceability
  • Applies to Retail Establishments
  • Only certain size establishments must comply
  • Aquacultured Fish vs Wild Caught

40
Conclusions
  • Regulatory Actions Can Disrupt Business
  • FDA Desires Compliance through Cooperative
    Interchange
  • Positive steps can be taken by industry
  • FDA will accommodate good faith disagreements
  • Stronger Focus on Food Chain
  • Importers are Held Responsible
  • Quality is a Driver for Change
  • Government/Industry Partnerships
  • Quality Management Influence on Policy

41
  • Thank you!
Write a Comment
User Comments (0)
About PowerShow.com