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[Note: suggest dropping "and other food commodities" as the work undertaken in OPDFB has been halted]

CFSAN Regulatory Codes: VIII
CFSAN Program Priority Codes:
Start Date: 5/1/99    Completion Date: 5/1/02

Statement of Research Problem:
Biogenic amines, which are formed by bacterial processes associated with spoilage, can have serious consequences. When held for excessive periods of time, the microflora of specific species of fish convert free amino acids to biogenic amines (e.g. histamine) that produce characteristic symptoms in humans, particularly those taking monoamine oxidase inhibitors. Production of scombrotoxins in these fish is dependent on the time and temperature of storage prior to consumption. The current project examines the production, processing, and distribution steps to establish the time and temperature limits to ensure minimization of decomposition related bioamine formation. Appropriate methods for individual foods will be developed and guidelines for bioamines in foods will be established.

Statement of Project Objective(s):
Develop a science base through experimental studies to support the development of guidelines, including critical control points and critical limits, for the seafood in which biogenic amine formation can lead to human health hazards.

Anticipated Impact on FDA Regulatory Program:
Some hazards resulting from decomposition have been partially characterized such as the relationship between histamine levels and the potential for scombrotoxin illness, others have been suspected but poorly, if at all, elucidated such as the risks posed by the formation of the diamines, putrescine and cadaverine. While a compliance policy guideline has been developed for histamine, action levels for the diamines will require additional data. FDA has established HACCP regulations for seafood, and is expected to develop similar requirements for other foods. Therefore, FDA needs to be able to determine if appropriate hazards have been identified and controlled when conducting inspections of processors and importers.

Project Priority Changes During FY2000:
The absence of funding and the presence of political disruptions affecting fish harvesting have delayed sample collections. The research on other commodities was cancelled due to redirection of resources in the operational office.

Administrative Liaison(s):George P. Hoskin: 202/418-3172

Research Personnel:


Name	Office/Division	FTE [00, 01, 02]	Component
Walter Staruszkiewicz	OS/DSAT/WSL	0.5, 0.5, 0.5
Patricia Rogers.	OS/DSAT/WSL	0.9, 0.9, 0.9
	Total FTE:	1.4, 1.4, 1.4

Component 1 Objectives:


1. Harvest live fish and subject them to time/temperature abuse over a range representing conditions known to cause the formation of scombrotoxic products.
   
2. Measure the sensory characteristics and levels of biogenic amines (histamine, cadaverine, and putrescine) which form at each condition.
   
3. Determine if significant residues of the amino acid decarboxylases remain in frozen loins prepared from the fish.
   
4. Compare the effects of long line operations on fish.
   
5. Determine the significance of early handling conditions to the temperature of the stored loins and later formation of the biogenic amines.
   
6. The differences in amine production between species (e.g. yellowfin tuna, mahimahi, swordfish)
Component 1 FY 2000 Deliverables:

1. Report on the effects of on-board and post harvest handling on mahimahi.
   
2. Draft a recommendation on regulatory limits for chemical and sensory indicators of decomposition in mahimahi.
Component 1 FY 2000 Progress:

1. Initial drafts prepared.
Technical Barriers to Meeting Component 1 Objectives or Deliverables: none listed
Component 1 FY 2001 Deliverables:

1. Determine the effects of on-board and post-harvest handling of tuna on long liner vessels.
   
2. Report chemical data on collected & treated fish samples as resources permit.
Component 1 FY 2002 Deliverables:

1. Prepare recommended guideline based on collected data.

Component 2 Objectives:


1. Evaluate test kits for application as screening tests for amines.
   
2. Participate as a collaborator on a test kit for histamine.
   
3. Evaluate the application of electronic sensor array technology for detecting ST fish.
   
4. Determine the safety of CO treated fish.
   
5. Determine the masking effects of chemical treatments (e.g. acid washes, additives, etc) on ST fish.
Component 2 FY 2000 Deliverables:

1. Publish a report on a comparison of histamine test kits.
Component 2 FY2000 Progress:

1. A report on histamine test kits is expected in the Journal of Aquatic Food Products Technology in 2000.
   
2. The sensor array instrument has been installed and tested on several products. Work is in progress on establishing reproducible experimental conditions to distinguish between acceptable quality and decomposed products.
Technical Barriers to Meeting Component 2 Objectives or Deliverables: none listed
FY 2001 Deliverables:

1. Report on applications of the sensor array instrument to selected fishery products.
   
2. Prepare a pack of CO treated tuna to test the formation of scombrotoxin ifs resources permit.
FY 2002 Deliverables:

1. Evaluate the transferability of data between sensor array instruments.
   
2. Evaluate the masking effects of chemical washes and treatments on seafood.

Component 3 Objectives:


1. Collect samples associated with illnesses.
   
2. Prepare authentic samples to mimic suspect samples.
   
3. Analyze the samples for biogenic amine content. Develop methods as needed.
   
4. Apply animal tests to the samples and compare with chemical results as resources permit.
Component 3 FY 2000 Deliverables:

1. Collect incriminated samples and conduct chemical analyses.
Component 3 FY 2000 Progress:
Very few samples have been received.
Technical Barriers to Meeting Component 3 Objectives or Deliverables:
(Logistics note) Need to arrange more timely notification by other FDA units when illnesses are reported and arrange for the relaiblel susubmission of samples for use in research.
Component 3 FY 2001 Deliverables:

1. Report on the analyses of incriminated samples.
Component 3 FY 2002 Deliverables:

1. Report on comparisons of chemical contents of authentic samples with incriminated samples.

Studies on foods other than seafood were cancelled during FY 2000 due to FTE adjustment for higher priority work and low priority concern for biogenic amine formation in spouts and other non-seafood commodities.

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Hypertext updated by dav 2001-OCT-02