Whenever an FDA inspector at the port of entry sample for canned tuna
this is send to the laboratory for decomposition and histamine analysis.
If the product is found to be decomposed or with histamine levels then
this entry is detained under Import Alert 16-105. The FDA import alert
16-105 for canned tuna states that canned tuna is subject to refusal of
admission in the United States because after sampling and testing it
appears to bear or contain histamine, a poisonous and deleterious
substance in such quantity as ordinarily renders it injurious to health.
This is considered adulteration, under Section 402(a)(1)] of the Food
Drug and Cosmetic Act.
There are other ways FDA may find out canned tuna could have histamine
this is through a consumer complaint. The complainant had a reaction due
to consumption of the product analysis test positive for histamine. FDA
probably will perform examination of future entries and if histamine is
found then the product is detained.
The manufacturing firm must have a HACCP plan that has a Critical
Control Point that prevents histamine formation during receiving and
process. Chapter 7 of the Fish and Fisheries Products Hazards and
Controls Guide, Third Edition, states that scombrotoxin formation is a
the result of time/tempera abuse of certain species of fish that can
cause consumer illness.
In addition to sampling canned tuna for histamine analysis the FDA can
detain canned product found injurious to health based on any of the
following:
a) The manufacturing firm failed to register under 21 CFR 108 for all
manufacturer that process low acid canned food products thermally
process under 21 CFR 113 or acidified food 21 CFR 114.
b) FDA field examination at port of entry detected that cans were
abnormal with defects such as swelling, springer, flippers, seam defects
that are critical that may result in the loss of the hermetic seal.
c) The manufacturing firm is under detention because is under Import
Alert 99-04, Detention Without Physical Examination of Manufacturer for
Low Acid Canned Food and Acidified products because the firm failed to
respond to verify information, failure to verify process, inadequate pH,
inadequate process.
d) Field examination detected that cans were mislabeled such as foreign
language, no information country of origin,
e) Failure by the manufacturer register under the Bioterrorism Act
f) Failure to submit prior notice at the port of entry.
Hope this answer and provide you guidance.
Angel M. Suarez,
Registered Sanitarian
Ceti
7865 Thor Drive
Annandale, VA 22003-1437
Tel/FAX 703-560-4499
E-mail: cetifish@verizon.net
Ko, Iwan Setiyono wrote:
>Dear all,
>I am interested to study canned tuna quality and need some assistance.
>Anybody would like to explain these following questions?
>
>1. Based on your experience, do you think the reject products when they
>are under US FDA detention do tend come from older can age (3, 4 or even 5
>years old) after production date?
>
>2. Do you think it's mainly due to the histamine content? Or other
>microbiological problems?
>
>3. How do you generally assess the quality of the canned product of
>increasing can age compared with the newly produced one, based on
>chemical, microbiological and sensory criteria?
>
>Looking forward to hearing it from you.
>
>
>
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