Dear Jairo (and many other colleagues that have sent me a number of inquires
on this subject):
Thank you very much for your comments (the same to the rest of my fish
technologists colleagues that wrote me). My comments to your observations:
1. You are right. This happens in practice. You are allowed to expand as much
as you wish the number of your CCPs, but not to ignore "regulatory hazards"
(being explicitly nominated in regulations or in supplementary guidelines and
documents like the FDA/CFSAN Fish and Fisheries Products Hazards and Control
Guidance, that is anyway an excellent document, one of the best if not the
best on HACCP in fish and fish products; read and re-read and read it again).
(*)
2. Surely you read my second answer, therefore you know that my personal
opinion is that if you have a control system in place functioning
satisfactorily (mitigating risk to the desired level) it does not matter too
much how you call their components. But I am not the law, and therefore if
the law asks for "white cats" the cat should be white. In the meantime there
is the need to develop scientific and technical evidence that the black cat
also could work and can catch at least the same number of mice or even more.
The serious problem is when this evidence does not exist (even when evidence
of the effectiveness of white cats may not exist). You are right to point
that the key points are monitoring and corrective actions, I would add
verification. In my opinion the serious problems occur because lack of proper
verification (systematic and through internal HACCP audits).
3. Again this is a very debatable point. Putting aside the discussion about
the colour of the cats, my personal technical opinion is that in dry
technical terms it will depend a lot on the particular situation. For
instance there are countries where black outs are very usual (now more with
oil prices going up) and not all plants have emergency electric generators to
make sure refrigeration equipment will continue to work during that periods.
Not to have a CCP in the cold storage room in these situations, regardless
what regulations could say or not, would be wrong. Independently of the risk
control (hygiene and/ or safety as you wish), one of the first reasons for
the HACCP-based regulations is to build-up assurance in the food (fish)
chain. Do not forget to read the Preamble and the Recitals of regulations,
they provide valuable information about why the regulations are written in
one or other way (you have to read all the regulation from the the first
letter till the last point, including signatures). The purpose of regulations
are not the technical purposes; but the purposes that appear in Preambles and
Recitals.
Returning to the assurance, if your customers and the people know that are
black outs (something easy to know, just staying there, reading the
newspapers or talking with the taxi driver that takes you from the airport)
and, you do not have a proper control to show regarding the temperature in
your cold storage room the assurance delivered would be very low or nil. Any
SSOP may become under particular situations a CCP. For instance I have been
in situations where the potable water to the plant arrived in trucks
(different trucks from different sources) no from public supply; in that case
each batch of water required monitoring, corrective action (or rejection) and
verification (some). The arrival of the truck with water was in practice a
CCP (very unstable situation, the only advantages were that the fish was at
the hand and the processing time till it was frozen was very short).
(*) From a personal point of view I am not too much in favour of HACCP Plans
with a large number of CCPs. People conversant with the Theory of Control
knows that each system has a finite number of degrees of freedom and that
controls could be installed only taking into account them. The fish industry
is still far to start to make this type of calculations, but it is good to
know that there are technical limits to "control everything". Additionally,
in practice, the increase in the number of CCPs is a burden on personnel in
charge of monitoring and deciding on corrective actions; and this have also
two negative influences the first one is that time between two different
monitoring exercises (for each single attribute) is usually increased and
very often verification is not done (not to say internal HACCP audit) because
lack of time (and assuming monitoring is enough). The consequence of
excessive time between monitoring actions is instability of the control
system, because of time delays introduced in the system, compounded by the
lack of verification. The pressure for quick analysis methods came from the
fact that the time required for some analysis (e.g. microbiological analysis)
introduce already a large time delay (1-2 days) for satisfactory control "in
real time". The advice is always the same "each case is a case", proper
Hazard Analysis and focus on your main hazards; finally fit to regulations,
you can not ignore them.
I will try to reply the rest of the colleagues that wrote me, but it will
take some time, because I have my work to do too (and I have to travel). In
any case I am not an oracle, I do not have the truth; only a lot of time and
lectures on this subject and perhaps very serious pressure, in more than one
case, when assisting a country that had "to pass" the visit of the fish
inspectors from the EU, US (FDA), Japan or Canada.
Kind regards.
Hector
-----Original Message-----
From: Jairo E Romero [mailto:jairoeromero@tutopia.com]
Sent: 11 October 2005 19:46
To: Lupin, Hector (FIIU); richard@fishonline.co.uk; 'alma tina';
seafood@ucdavis.edu
Subject: RE: inquiry about cold storage being considered as CCP
Hector
Some ideas come to my mind reading your excellent insight.
1. Industry must deal not only with science based CCP's and
regulation based CCP's but also with Client's CCP, as is the frequent case
with metal detectors
2. In my opinion, if at a certain stage you have correctly identified
the food safety hazards and the control limits, have in place an adequate
monitoring system and take proper corrective actions when necessary, to call
it a CCP or not is not as transcendental as it looks.
3. Cold storage is rarely a CCP.
JAIRO ROMERO, M. Sc.
Consultor Internacional en Inocuidad y Comercio de Alimentos
Cra. 4 # 16-29 Of 404, Bogotá DC, Colomia
Teléfono (571) 282 4224
Móvil (57) 315 309 5343
_____
De: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] En
nombre de Lupin, Hector (FIIU)
Enviado el: Martes, 11 de Octubre de 2005 03:48 a.m.
Para: richard@fishonline.co.uk; alma tina; seafood@ucdavis.edu
Asunto: RE: inquiry about cold storage being considered as CCP
Dear colleagues:
This is a very interesting discussion, that pops up very frequently.
I think that there are some general considerations:
(i) Regulatory HACCP is not HACCP (e.g. in the sense of HACCP
according the Codex Alimentarius) but a regulation based on HACCP. Therefore,
in principle, you have to comply with a regulation and not just with the dry
HACCP principles and/ or steps.
(ii) Regulations, as any other piece of knowledge, is open to
interpretations. "Interpretations" are usually a problem. Inspection agencies
in general make every possible effort to make interpretations, of their own
officers, uniform. But not always succeed.
(iii) One of the aspects of HACCP-based regulations is that they
determine directly or indirectly "regulatory hazards"; this means hazards
that you shall be taken into account in your HACCP plan, regardless which
could be your own technical opinion. In the case of the US FDA HACCP-based
regulations theoretically you may eventual appeal (if you are in the US),
based on scientific grounds. However, for most "regulatory hazards" the
possibility somebody could demonstrate they are not hazards (e.g. histamine
in pelagic fish) is usually very remote.
Regarding the EU directives there are a couple of things to clarify
(translate from EU English to USA English):
(a) HACCP for fish and fish products is called "own-checks".
(b) CCP is called "Critical Point"
(c) "Hazard is a potential to cause harm to health and is anything
covered by the hygiene objectives of Directive 91/493/EEC" (bold and Italics
mine)
(from Commission Decision 94/356/EC of 20 May 1994)
Going to Council Directive 91/493/EEC we found the following:
(1) "- frozen fishery products, with the exception of frozen fish in
brine intended for the manufacture of canned foods, must be kept at an even
temperature of -18 º C or less in all parts of the product, allowing for the
possibility of brief upward fluctuations of not more than 3 º C, during
transport;" (Council Directive 91/493/EEC, Annex, Chapter VIII, Storage and
Transport, Point 1) (bold mine)
(2) "3. Storage rooms must have a temperature recording device in
place where it can easily be read. The temperature sensor of the recorder
must be located in the area furthest away from the cold source, i.e. where
the temperature in the storage room is the highest. Temperature charts must
be available for inspection by the supervisory authorities at least during
the period in which the products are stored." (Council Directive 91/493/EEC,
Annex, Chapter IV, Special Conditions for Handling Fishery Products on Shore,
II Conditions fro frozen products, Point 3) (bold mine)
And finally, and perhaps the most important for this discussion:
(3) "Critical limits may be derived from a variety of sources. When
not taken from regulatory standards (e.g. frozen storage temperature) or from
existing and validated guides of good manufacturing practices, the team
should ascertain their validity relative to the control of identified hazard
and critical points" (Commission Decision 94/356/EC, Chapter II, Point 1).
(bold mine)
In this case the regulation is not saying that the cold storage
temperature is a CP (a CCP); but is given all the indications in that sense
(critical limit, tolerance, measurement and record keeping and use it as
regulatory example). The need for corrective actions, in the case of
deviations, is obviously a result; and the need for verifications of
measurement and record equipment fall into the general principle of
verification and calibration and re-calibration of measurement equipment.
Therefore we have our regulatory hazard and CP (or CCP).
Again, the possibility that in this situation a fish inspector from
the EU do not consider the temperature in a cold storage room a CP (a CCP) is
remote. He/ she may eventually accept that continuous records could be
replaced by recorded lectures, say every 3-5 hours (taking into account the
thermal inertia of cold storage rooms); but hardly that it is not a CP
(CCP).
The discussion about the rationality or not of frozen storage
temperature as a CP (or CCP) is interesting; I am tempted to go on that, but
not time now. In any case we should keep in mind that HACCP based regulations
(or by the case all Risk Analysis) are based on Science, they are not
Science.
I have worked with people in developing countries that want to export
their fish. People normally ask you to provide an advice that put them into
the safe side. Which advise would you provide in this case?
(Warning: from 1 January 2006 there will be a new set of EU
regulations dealing with HACCP, and a new careful reading of regulations is
necessary for all trading fish with the EU)
Kind regards.
Hector M. Lupin
Senior Fishery Industry Officer (Quality Assurance)
Fish Utilization and Marketing Service (FIIU)
Fishery Industries Division (FI)
Fisheries Department, FAO, Room F 606
Viale delle Terme di Caracalla
00100 Rome, Italy
Tel + 39 06 570 56459
Fax + 39 06 570 55188
E-mail: hector.lupin@fao.org
-----Original Message-----
From: owner-seafood@ucdavis.edu
[mailto:owner-seafood@ucdavis.edu] On Behalf Of Richard Chivers
Sent: 07 October 2005 16:36
To: alma tina; seafood@ucdavis.edu
Subject: RE: inquiry about cold storage being considered as
CCP
Hi Alma,
These are my views:
1. There are no EU directives that set CCPs, these are
up to the processor to determine.
2. I assume you refer to the Competent Authority. I
would not consider cold (frozen) storage a CCP simply because a product that
is intended to be kept in be frozen condition would be in breach of
specifications and GMP, drawing in quality and safety issues. I would set
the temperature control as a prerequisite programme; a given if you like.
I.e. if the product temperature were outside the limits, that would be the
end of it for its primary purpose and disposal or alternative use should be
considered.
3. Pathogen growth is unlikely to present a food safety
hazard due to the reasonable expectation that the product would be cooked.
That is unless there were an issue with spore formers or with heat resistant
toxins then there would be a problem. These matters would be highlighted in
the analysis part of the HACCP. Unfortunately it is not an argument that
sways opinion in international trade which will set stringent micro counts.
4. It is not illegal but may mean that your analysis was
invalid if a CCP were missed. In the UK this alone would not lead to
prosecution but could become evidence to support a prosecution if there were
more serious matters arising from temperature abuse i.e. food poisoning.
I hope this helps
Richard Chivers
-----Original Message-----
From: owner-seafood@ucdavis.edu
[mailto:owner-seafood@ucdavis.edu]On Behalf Of alma tina
Sent: 07 October 2005 06:34
To: seafood@ucdavis.edu
Subject: inquiry about cold storage being considered as CCP
Dear List,
Please give me some insight or enlightening regarding the
issue of considering cold storage as CCP.
These are my questions:
1.Is there an EU directives that considers storing at cold
storage as CCP.
2.Can the competitive authority insist on us to consider
storing at cold storage as CCP.
3. Is my thinking correct, that since our product is to be
fully cooked before consumption, then pathogen growth is not a hazard? By the
way our products are frozen octopus and shrimps.
4. Is it illegal not to have CCP for a particular item?
Plese provide some information on this issue, we badly needed
the info.
Thanks,
Alma O. Tina
almaorodiotina@yahoo.com
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