Dear James,
I have put together the last 2 messages received from FDA specialists on the
subject (yourself and Walter 's messages below attached) and I believe there
is certainly something to reflect on... I fully understand you will not be
able to answer on the FDA policy issues but I still feel important to share
my views with you, your colleagues and the list members.
If you ask me today about my need, as an inspection company, to purchase or
detain such equipments I would say yes but without real interest as
today the certification of the quality relies on some export certification
schemes, quality assurance programs or state regulations which put
practically at the same level the controls for histamine and
Microbio.....and the microbio test requiring a long time to process there is
sufficient time for the histamine tests to also take place in a
laboratory....so no real need for quick tests as you imagine....
But as suggested by Walter the establishment of a proper control mechanism
along the supply chain would certainly call for numerous field tests
to be duly recorded as part of a global quality insurance program involving
spot controls at time of catch, on board handling, discharge, transit
points, transport, process, export ....
I believe we all know where the problem lies but we do not want to see
it.... FDA and EU are pushing very hard for some new regulation to take
place to force the suppliers (through the importers concern and liability)
to build up, monitor, audit and promote a full quality program including,
HACCP, Temperature abuse, mixture of catches reacting differently to
histamine creation, clean process, and final export certification. And we
must all admit that it just does not work but the consumer desperately need
that confidence building process...And such needed program goes with
traceability and field spot checks for sensible parameters such as
histamine......
The question is certainly to decide today on who and how such "valid control
mechanism" could be set up ?
Is it left to the industry to decide or would FDA be ready to discuss or
even push one way or another for implementing same? Even if FDA does not
wish or cannot be directly involved could we imagine them giving the
blessing to an inspection firm having sufficient network and resources to
prepare and audit the industry worldwide ? In such case the need for those
quick checkers on histamine would be there and the main client/user would be
the inspection company itself...being the arm of FDA and EU...
According to my records, in the 1990 the National fishery Institute NFI
started something similar by making a joint venture with a major
consulting firm for offering HACCP training/audits in several
countries....The scheme was voluntary and lacked strong support from state
agencies...
This kind of "Train the Trainers" program might be the solution but it
should then be extended to cover on board handling, Histamine creation,
HACCP/Temperature monitoring and final lab procedure...
This is the direction the EU is taking by offering some funding to selected
countries who accept to put their fishing dept at level regarding EU
regulation (done through the use of consultants).
Same potential partner could even set up control programs for checking sea
food in restaurants, markets, cold stores etc.... under a different mandate
in a specific country !
Just some thoughts. I am not really sure they fit in your concern and even
answer your question but I believe this is a concern to start working on if
we want safe sea food in our plate for the years to come...
Best regards.
Alain Schalk
Cotecna Inspection SA
_____
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf
Of Hungerford, James M
Sent: 31 January 2005 19:40
To: 'seafood@ucdavis.edu'
Subject: Histamine Field Test
A question for those in the seafood industry, government regulators,
inspectors, analysts, etc:
How many of you would purchase and use a simple and rapid field test for
histamine in fresh, frozen, or canned fish?
I am exploring the possiblities for a commercially available field test kit
for histamine that would use a simple cassette format (lateral flow cassette
as used in pregnancy test kits). There would be no chemicals to handle, and
no solutions other than the distilled-water extract of fish (prepared on
site) since the test kit itself is "solid state." The kit would respond in
approx 30 min. Sample requirements are low and their is potential for less
"disfigurement" of the fish as discussed on this forum. Results would be
qualitative (for example "above 50 PPM" or "below 50 PPM") and would mainly
be used for screening and for quality control.
Roughly how many tests would your firm or agency perform each year?
What do you feel is a reasonable cost per sample?
Please note that although I work for FDA, statements made in this message do
not reflect FDA policy.
Please respond with your thoughts on this.
Thank You for your time.
Sincerely,
James Hungerford, Ph.D.
Chair of AOAC Task Force and GR, Marine and Freshwater Toxins,
Research Chemist
FDA Seafood Products Research Center
22201 23rd Dr SE
Bothell, WA 98021
USA
Phone 425-483-4894
FAX 425-483-4996
Message from Walter Staruszkiewicz in November 2004
"Consumer illness from the ingestion of decomposed and scombrotoxic fish
remains a major public health problem. Most of the unsafe fish are received
as imported products. There has been a long standing problem of inadequate
attention given to preventing bacterial decomposition at the point of
harvest which results in the production of irreversible unsafe chemical
changes in fish.
"The progression of bacterial decomposition which leads to the formation of
histamine and other biogenic amines begins in the anterior end of a fish and
the highest concentrations of the amines are usually found in the lower
anterior region. These changes are not always accompanied by obvious odors
of decomposition within the muscle. It is necessary to sample the tissue at
the anterior end cutting through the transverse section (backbone to belly)
to have a high degree of reliability in assessing the safety of the fish.
The sample location rather than the amount of tissue is the important
factor. Our publication in the January
2004 issue of the J of Food Protection* documents the rapid formation of
biogenic amines in susceptible fish.
"The reality is that fish are harvested, delivered, transported and offered
for sale in the U.S. that contain high concentrations of histamine due to
bacterial decomposition. These shipments of fish usually consist of a
mixture of very good quality fish commingled with decomposed and unsafe
fish. They may be accompanied by "certificates" alleging an absence of
histamine or decomposition. Our laboratories have identified scombrotoxic
levels of histamine in such shipments and we have had numerous reports of
consumer illness from scombrotoxic fish delivered at the retail level.
"Until a valid control mechanism is established from the point of harvest at
sea through the delivery of fish, chemical analysis will remain the only
reliable test of safety for scombroid-type fish. "Certificates" and good
intentions will not suffice as substitutes."
Walter Staruszkiewicz
Research Chemist
FDA
Laurel, MD
________________________________________________________________
This communication contains information that is confidential and is intended
for the exclusive use of the addressee(s) only. The unauthorized reading,
disclosure or copying of this email is strictly prohibited. If you are not
the intended recipient(s), please note that any distribution, copying or use
of this communication or the information contained in it is strictly
prohibited. If you have received this communication in error, please notify
the sender immediately and then destroy any copies of it. The content of
this message does not reflect the opinion of the Cotecna Group or any of its
affiliates except to the extent that it relates to their official business.
Cotecna Group strives to protect itself from computer
viruses. However, as new viruses constantly appear, we do not accept
responsibility for the effects of any virus which you may contract from us.
We encourage our correspondents to implement anti-virus software, and to
keep it up to date.
This archive was generated by hypermail 2b29 : Wed Feb 02 2005 - 01:02:28 PST