Uneviscerated Fish
Feb 2, 2011
Food Safety Partnership
Defined • Internal organs
– Not removed
– Partially removed
• Head on/off
• Air dried
– Salted
– Smoked
• Whole fish, pieces, ground, powdered
Food Safety Issues
• Clostridium botulinum
– Type E • Processing Controls
– Drying
– Salting / Smoking
• Post process handling
• Intended use
– No additional preparation
– Seasoning / Flavoring
Prior Outbreaks
• USA, 1981‐87: 3 outbreaks of botulism, causing 3 deaths and 11 illnesses, from eating kapchunka
– Kapchunka is an uneviscerated, salt‐cured, air‐dried, whole fish, which may or may not be smoked. It is consumed without further preparation, such as cooking. – In 1987: 8 cases of botulism in NYC and Israel
• Egypt, 1991: 91 cases and 18 deaths from faseikh
purchased from one store
– Faseikh is uneviscerated, salted mullet fish
– Largest type E botulism outbreak ever reported
Prior Outbreaks
May 1992, NJ: 4 family members ill after eating moloha, an uneviscerated, salt‐cured fish. No moloha was found at the market and ultimate source not identified.
Types
•
•
•
•
•
•
Kapchunka (aka rybetz, rostov) Bony fish (large, small)
Kagnabe
Yellow Corvina
Faseikh
Moloha
Uneviscerated
Kangbe fish,
dried and
moked.
Uneviscerated small
Bony fish, dried and
smoked
entrails
Container of small dried,
smoked Bony fish
March 2010
•
•
•
•
•
•
Joint Investigation ‐ FDA, MDA, Local Health MDA notified that MN Wholesaler was selling the product
Violation of FDA Import Alert 16‐74 Frozen, Refrigerated, and Ambient Temps
No documentation for ‘approved source’
Products Embargoed and Sampled
Traceback indicated sources in Africa Actions/Findings
• Issued surveillance assignment to delegated agencies
– Identify and visit stores potentially carrying African foods
– Embargo any uneviscerated fish
– Confirm any eviscerated fish came from approved source
• Samples collected • Trace back investigation
Actions/Findings
• 120 firms reviewed by MDA and local health
• Dried Uneviscerated Fish found at 16 Retail Firms
• African & Non‐African Sources
• Products bought directly from Africa, importing firms, and distributors in TX, NJ, NY
• No documentation of ‘approved source’
• Total 760 pounds Embargoed, Condemned, Destroyed
Trace Back
Unknown Supplier 1
Guinea
Source for large Bony
fish
Supplier 2
Monrovia, Liberia
Source for small
Bony fish &
Kagnbe fish
Unknown Supplier 3
Source for large and
small Bony Fish
Unknown Supplier 4
Source for large and
small Bony Fish
Importer 1
Newark, NJ
Importer 2
Brooklyn Park, MN
Importer/Supplier 3
NW Metro Twin Cities
Importer/Supplier 4
NJ
Retail Store 1
Brooklyn Park, MN
Retail Store 2
Brooklyn Park, MN
Distributor A
Brooklyn Center, MN
Wholesaler/Retailer 1
Brooklyn Park, MN
Retail Store 3
Brooklyn Park, MN
Retail Store 4
Brooklyn Park, MN
MDA Press Release
Reaching the Somali & Oromo Communities through ECHO
November 2010
Joint Investigation – USDA APHIS, FDA, MDA, Local Health • USDA APHIS finds suspect dried fish products in metro warehouse
• FDA conducts initial investigation – appears to be uneviscerated Bony Fish
• Boxes had minimal labeling – additional products? • Records (invoices, BOL) are scarce and incomplete
• Initiate investigation at second firm – found additional Bony Fish
• All suspect products embargoed, sampled
Critical Factors
Critical Factors Food Safety Standard
Length of Fish
Less than 5 inches
% Salt in Water Phase
Greater than 10 %
Water Activity Less than 0.85
Source: FDA Import Alert 16-74 “Detention Without Physical
Examination of Salt-Cured Air-Dried Uneviscerated Fish" Date
Published 02/22/2010.
MDA Laboratory Results
Critical Factor
Food Safety Standard
Results
Average Range Length of Fish
Less than 5 inches
5.681 inches
4.7 – 7.08 inches
% Salt in Water Phase
Greater than 10 %
4.3 %
2.8 – 6.5 Water Activity Less than 0.85
0.854
0.72 – 0.95 Actions/Finding
•
•
•
•
Surveillance Assignments – limited retail firms No products found outside of original firms
Uneviserated Fish – deemed Adulterated Condemnation and Destruction
Regulatory Challenges
• Receiving firms’ understanding of expectations
• Approved Source – defined ?
• Imported Products – what documentation is required
Authorities/Expectations
• All agencies that can enforce the MN Food Code have power of – Embargo
– Condemnation
– Food Sample Collection
• Look for products during inspections of relevant facilities – Notify MDA if products – even suspect products are found. Resources
• FDA Compliance Policy Guide Sec. 540.650 Uneviscerated Fish Products that are Salt‐cured, Dried, or Smoked (Revised) Updated 11/29/2005.
• http://www.fda.gov/ICECI/ComplianceManuals/Compliance
PolicyGuidanceManual/UCM124048
• FDA Import Alert 16‐74 “Detention Without Physical Examination of Salt‐Cured Air‐Dried Uneviscerated Fish" Date Published 02/22/2010.
• http://www.accessdata.fda.gov/cms_ia/importalert_48.html
Resources
• FDA Guidance to Industry: HACCP Regulation for Fish and Fishery Products; Questions and Answers for Guidance to Facilitate the Implementation of a HACCP System in Seafood Processing (Issue Three: January 1999).
• http://www.fda.gov/Food/GuidanceComplianceRegulatoryInf
ormation/GuidanceDocuments/Seafood/ucm176892.htm
• Title 21 Code of Federal Regulations 123: Fish and Fishery Products.
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR
Search.cfm?CFRPart=123
Resources
• Fish and Fisheries Products Hazards and Controls Guidance: Third Edition June 2001 • http://www.fda.gov/Food/GuidanceComplian
ceRegulatoryInformation/GuidanceDocument
s/Seafood/FishandFisheriesProductsHazardsa
ndControlsGuide/default.htm
• Emergency and Community Health Outreach
• www.echominnesota.org