Dear Oscar,
As I already answered to some people by separate mail (and as you know), I am
not a EU fish inspector and I have not been a EU fish inspector (or in any
other country) before joining FAO (the only "official" inspection title I
have is to be "HACCP Auditor" for fish and fish products of Cuba, because I
assisted them to build up the HACCP Audit System and they decide that I
should have some formal title to start up all the system; but even if linked
to practice I take it as a sort of "honorary" title). In any case no link
with the EU or any other fish inspection service.
I think that in our case is very delicate (and risky) to provide
interpretations of national regulations (no matter if from the EU, US, or for
the case any other country) because regulations are a strict national
business. The only thing we can do, in my opinion, is to read an analyze
carefully the regulations and see what is in, and (that is also important)
what is not there; and advise consequently. The real problem, in my opinion,
are not the "things that are in" but the things that are not there, or that
are implicit. Regarding the "things that are in" you can technically agree or
disagree, but they are there and if your objective is compliance for export
the same industry people will tell you at the very end "do not argue about
that". Missing or implicit things in regulations are far more complicated to
deal with.
Just an example, in the EU regulation that introduces traceability
(Regulation (EC) No 178/2002) there are not indication on aspects like for
instance the types of information to be kept, time of reaction for
traceability data availability, time of records keeping and role of internal
traceability. During an international meeting, early 2004, I though it was
not harm to mention that (taking in mind that our purpose is to protect
consumers and to facilitate trade). A representative of the EU asked for the
floor and expressed that there was not need that the EU were observed by FAO
on their own regulations. Nothing actually happened at a formal level (I
suppose they understood that my purpose was not attack the EU, where I and my
family live), but I think this case is clear to illustrate some of the type
of problems that could appear. Regarding this specific case, now there is a
EU "Guidance on the implementation of articles 11,12, 16, 17, 18, 19 and 20
of Regulation (EC) No 178/2002 on General Food Law" (Dated 20 December 2004)
that addresses large part of the observations. Of course, the EU has
mechanisms (and other developed countries too) to deal with that kind of
problems, but it can take some time to solve them. In the meantime problems,
interpretations and procedures (right or wrong) develop, investments are
done, etc.
However, till certain point, this type of problems is unavoidable. First of
all it can not be expected all the details be in regulations; for instance a
number of aspects may fall in the flexibility that regulations allow to the
industry. In second place, regulations as the one on HACCP imply a large
change (a real paradigm shift in Kuhn terms) and it can not be expected that
the texts be all right in the first go, and particularly it can not be
expected that all the people involved change their minds overnight. A large
part of the people involved with HACCP, continues to be pre-HACCP minded
people, and obviously they interpret HACCP in their own mind terms (e.g.
hygiene). I like to talk regarding HACCP as of a paradigm shift because it
explains why it takes such a long time to become something normal. I would
like to correct myself, the actual paradigm shift is Food Risk Analysis.
HACCP is just a risk management tool. Risk Analysis (risk assessment + risk
management + risk communication) is the right field from where analyze HACCP
and any other risk management tools. We do not control hazards, we may
control risk associated with a given hazard, but we can not control hazards.
There is not zero risk either. The key point is the relevance (risk +
severity) of a given hazard.
We can control at plant level only through macroscopic measures, such as
temperature control. For instance if we keep a fish in ice, with temperature
near 0 º C, we are delaying the growth of fish spoilage (own flora) bacteria
and at the same time we are preventing the growth of contaminant (pathogenic)
bacteria like E. coli O:157; Salmonella spp, Shigella spp; S. aureus, etc.
(not Listeria monocytogenes). When we control temperature, we are not
targeting any hazard in particular (we may for instance choose in this case
E. coli O:157 or Salmonella spp as a key pathogen; it will depend on the
expected type of consumption, real health risks appear at the time of
consumption). However, simultaneously we are going to have a "Hygiene Plan"
(EU) or a SSOP (US), for instance for "water and ice" whose objective will be
also (among other things) to prevent contamination with pathogens. This means
that we try "to control" the risk, of say E. coli O:157 in our final product
through a number of different measures. Say CP (or CCP) and HPs (or SSOPs).
As fish consumer, I would like to say, as a former Chinese President; "I do
not care if the cat is black or white, as far it catch mice".
In regulations you can transform HPs (or SSOPs) in CP (or CCP), but the
opposite is not allowed. The reason is that CP (or CCPs) are considered a
higher level of control than HP (or SSOP). CP (or CCP) means more continued
and targeted control of certain type of hazards, that for our product are the
most important, or the ones that we could expect to find more usually
according Epidemiology records and/ or Toxicology. CP (or CCP) are more
costly and demanding than HPs (or SSOPs), and from what we could see from
Epidemiology the most effective thing to do in terms of resources (public and
private) is to concentrate really on the most relevant (specific) hazards.
Spoilage as a possible health hazard has in a number of EU countries deep
cultural roots, and to analyze it will require to write a book and a lot of
additional research to discuss properly about it. The departing point is that
during spoilage a number of non-volatile amines (putrescine, cadaverine,
spermidine and according to the fish specie also histamine) are formed. The
amount of Total Volatile Basis (Nitrogen) (TVB-N) is a indirect measure
measure of such non-volatile amines, even if such a thing is not recorded in
most books. In this way TVB-N enters in EU regulations as something in the
borderline between hygiene and public health. The point of discussion is not
the production of volatile basis (ammonia, TMA and DNA) they can not be
considered toxic at the levels appearing in spoiled fish. The point is the
production of non-volatile amines. Are they really toxic at the levels that
can appear in fish? Is this knowledge coming from a historical period when
fish arriving to consumers was relatively spoiled? Did it affect some
special type of consumers (e.g. babies)? (in the old times when ice was
scarce or not utilized, the last catch was very often reserved for children).
I do not have answers to these and similar questions.
On histamine there seems to be a world agreement to "title" it as a hazard.
However, you will find people (and countries), mainly in Asia, that challenge
the notion that histamine is a real hazard. Are they more resistant, by
genetic information, to histamine? Do they eat comparatively smaller portions
of histamine prone fish, than people in developed countries? No answer to
this.
Our perception of hazard and risk associated with it it is very much related
to the amount consumed and the frequency of the outbreaks. In the Caribbean,
ciguatera is a fish number one hazard, and even it kill people. In the US is
considered a hazard but nothing special (even put as example of Class II
recall). The difference is in the number of cases per outbreak. In the
Caribbean the number of cases per outbreak are from 1 to 2.5 in the US the
recorded outbreaks have a large number of cases (e.g. 8-10, I am citing by
heart here). This means that every time it appeared a fish with ciguatera it
was consumed by a number of people, whereas in the Caribbean the same fish
was consumed by one or two. The exposure to toxin is higher in the case of
the Caribbean people. The perception of the hazard is completely different.
The Europeans say spoilage is a hazard, we could argue and discuss about it.
But the same thing could be said about many other hazards, particularly when
seen from different perspectives.
Finally the difference between fresh and frozen fish (of the same specie and
kind) is something also entrenched in the traditions, and regulations, of
many EU countries. It is possible to pass from frozen to thawed fish, but it
is not allowed to pass from frozen to "fresh fish". You may said that after
cooking there will be not too much difference. Well, perhaps, it depends of
the fish specie. But here the problem, is not a a problem of safety (or
hygiene) it is a commercial problem. Commercial loyalty. Again laws are a
whole and should be (or try to be) consistent.
The transport of live fish (for food) is one of the less covered areas in
regulations, and clearly there is an overlap of regulations in that case. The
Codex Alimentarius approved just this year a guideline about transport of
live fish (with food purposes), but from there till it be properly reflected
and incorporated (and likely improved) in national regulations may take some
time.
I would like to close this long reply, repeating again that Risk Analysis,
and therefore any regulation, is based on science, it is not science. Large
mistakes and misunderstandings could came out from the assumption that
regulatory HACCP (or any other risk management tool) can be discussed and
argued in terms of pure science and technology. Regulations incorporates what
in the US is called "values"; it may have different meanings in different
countries, but basically is what the "people" think and/ or form part of
their own cultural baggage. One of the largest challenges to find out the
equivalence of regulations are the difference of "values". No surprise, the
same happens with globalization.
I do not say not to discuss or argue scientifically about regulatory HACCP,
eventually it will help to improve regulations and practice. However, we can
not expect that regulations be the revealed truth, and be surprised every
time we find out they are not. In particular, the discussion of "values X"
against "values Y" could be endless; and at the very end as the English
saying says: "Who pays the piper, choose the tune".
Kind regards.
Hector
-----Original Message-----
From: oscar.doporto [mailto:oscar.doporto@wanadoo.fr]
Sent: 12 October 2005 00:03
To: Lupin, Hector (FIIU)
Cc: seafood@ucdavis.edu
Subject: Re: inquiry about cold storage being considered as CCP
Dear Hector,
Each time I am approaching the condition of being ready for the "psy"
after suffering from exotic interpretations of the EU regulations, you point
out the matter.
In fact, many European (national services inspectors, going on time
to time to give some "help" to third countries) spread the idea of all
hygiene aspects being associated to critical points. I so manuals and
guidelines proposing HACCP model plans containing about 15 critical points
for the most simple case of little processes raw product...Additionally the
regulation introduce the idea of "own-checks" supposed to be equivalent to
HACCP but they do not trust in the companies "own-control" and, as a
consequence in many third countries, the inspectors are still convinced that
the results depends on the inspector presence and interference.
About limits of temperature the interpretations ca be really extreme.
My view is that frozen storage should no be considered a CCP. How important
should be a deviation for involving the idea of "Hazard", given in the point
(c) bellow?.
But what do you think about rejecting (with consequent destruction)
tons of lobsters because not arriving alive either at a temperature of 0°C to
+2°C (the criteria for fresh fish in the 493, but referred to the
transportation and preservation of fresh product in the respective chapter,
being a final product and not a raw material) having the only problem of
being captured and not having the time to cool down in the abundant ice
present!!!
The problem comes from mixing "hygiene" with process parameters
control, and taking out from its intention and framework certain regulatory
texts.
(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)
In addition, with the horizontalisation of regulation, the situation
will suffer further deterioration.
Tanks for the opportunity to talk about ,
Best regards
Oscar do Porto
International Consultant
----- Original Message -----
From: Larry Wyatt <mailto:larrywyatt@foodhorizon.com>
To: Lupin, Hector (FIIU) <mailto:Hector.Lupin@fao.org>
Cc: richard@fishonline.co.uk ; alma tina
<mailto:almaorodiotina@yahoo.com> ; seafood@ucdavis.edu
Sent: Tuesday, October 11, 2005 6:33 PM
Subject: Re: inquiry about cold storage being considered as
CCP
Hector,
I think your explanation of the difference between HACCP and
regulatory actions based on HACCP is excellent, and more important, is that
it is too often overlooked.
Larry Wyatt
FoodHorizon Inc.
www.foodhorizon.com
Lupin, Hector (FIIU) wrote:
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,
<!--[if !supportEmptyParas]--><!--[endif]-->
These are my views:
<!--[if !supportEmptyParas]--><!--[endif]-->
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.
<!--[if !supportEmptyParas]--><!--[endif]-->
I hope this helps
<!--[if !supportEmptyParas]--><!--[endif]-->
Richard Chivers
<!--[if !supportEmptyParas]--><!--[endif]-->
-----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
<!--[if !supportEmptyParas]--><!--[endif]-->
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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