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Dear Charles (and other people that wrote to me directly more or less on the
same subject),
There are a number of different things in your (Charles) enlarged question:
(i) Yes, fish inspection services could contribute you meet part
of the US FDA requirements. Specifically to fulfill Affirmative step B (you
shall complain with one of six alternatives presented in the regulation);
that reads: "Obtaining either a continuing or lot-by-lot certificate from an
appropriate foreign government inspection authority or competent third party
certifying that the imported fish or fishery product is or was processed in
accordance with the requirements of this part;" (Italics and bold mine).
(21 CFR Parts 123 and 1240; Section 123.12. Section 402 of the Federal Food,
Drug and Cosmetic Act; USA)
Since this does not come from a Memorandum of Understanding (MOU) between the
USA and a specific country (there are not MOU even between USA and Canada);
your fish inspection service is doing you and your commercial partner in USA
a favor (they are not obliged to do that). If you do not have a yearly
"reassessment" as requested by the USA regulation and your fish inspection
service do not sign the certificate; they are doing the right thing because
the only condition put forward by the USA regulation is to certify that the
"fishery product is or was processed in accordance with the requirements of
this part". And "this part" (the regulation) asks for it. Forget the type of
certificate, the Americans are not asking for any specific wording, and it is
obvious that your fish inspector will give you one of the type they have at
hand (I guess that after this point FDA people will look at French Polynesia
certificates with a bit of more trust).
(ii) Now, you could choose to select other type of "affirmative
step" to export to the USA; this is possible from the point of view of USA
regulation, and then you will not have to ask (in theory) a health
certificate from your local fish inspector. However, here could play other
considerations. For instance there are countries from which you can not
export food or fish without a local health certificate regardless it is
required or not in the importing country. I do not know the situation of
French Polynesia; but condition in European countries is uneven; nevertheless
with the new EU food regulation since January 2006, all food exported from
any EU country should have a health certificate. If this is the case of the
French Polynesia (as it is the case in many countries) it is not the reason
to have two certifications of (almost) the same kind, because it will add
cost without to increase fish hygiene and safety.
Now there is a new element in the picture, and it is the USA Bioterrorism
Act. My personal recommendation to fish inspection services in developing
countries that have asked for advice (again, this is not necessarily the case
of the French Polynesia) is that they should inspect all shipments to USA.
Implications for the exporting country could be potentially rather serious to
leave all the exporting process just to private arrangements and
certifications.
(iii) As I wrote in my previous note "reassessment" (USA) should be
documented, at least, once per year. For "review" (EU) there is no period of
time. However, reasons for proceeding to a review are clear in the EU
regulation and personally I thing that if a HACCP plan under EU regulations
have not been reviewed in one year or more, something wrong happens. Again
the problem is not to have a paper saying that you have "reviewed" or
"reassessed" your HACCP and Hygiene plans, but that you recorded what you
have done in the case your processing line, products, conditions, etc. have
changed (see my previous note). As the EU regulations reads, the purpose of
"review" is to assure that: "... the system .... is still valid in case of
change". Changes, not certifications are the important thing (in both
regulations).
It may be the case of very simple processing; for instance always the same
fresh fish, the same processing, the same packaging, etc. I can not say
anything else, there are no enough details in Charles e-mail to judge this in
depth (it does not exist HACCP Audit by mail). However, I have performed
HACCP audits in dozens of countries and never I found such a situation of no
need of "review". For training reasons I am credited HACCP Auditor for fish
and fish products in a couple of countries and I never found such a
situation.
Fish Inspection (that is part of Risk Management) is based on Science but it
is not Science. The reason is that in fish inspection (and regulations),
values (e.g. politics, costs), play a role and therefore it is not only
scientific and technical information. Therefore, could, for instance, exist
instructions for implementation (e.g. not to ask for "review" for X number of
years) that I (and perhaps you) do not know. HACCP regulations are relatively
new and that kind of things had happened. HACCP regulations did not exist
they started to exist a decade ago.
(iv) Yes, there is a lot of confusion of what is a "HACCP system".
The confusion is harmless (in my opinion) till it affects the definition of
the "HACCP system to audit", and at that point is necessary to be a bit more
clear. In practice there are three levels of HACCP "systems", as appear in
the next table:
Level
Name
Specificity
Criteria
Guidelines HACCP (e.g. Codex)
General (Universal/ Academic)
Regulations
(Regulatory systems)
Regulations based on the HACCP criteria; or "HACCP-based" regulations
Country specific (vertical/ horizontal regulations)
System
HACCP and Hygiene (or SSOPs) plans & practice
Specific for plant and product and regulation.
Even if the three levels are called indiscriminately "system" they are not.
In theory the three levels could be audited (reviewed/ reassessed) separately
if necessary, but when we talk about HACCP audit, specifically we are talking
about the audit of HACCP and Hygiene plans (box in blue in the table).
The 7 principles and the 12 steps are just common criteria. The EU and the
USA FDA regulations are just two examples of "HACCP-based" regulations, they
are not identical regulations (harmonized), even if based on the same
criteria. This happens due to a number of reasons and it is not easy to
explain. Let me try a general explanation.
Each country follows a certain Risk Analysis approach to deal with risks in
food. A part of such approach is called Risk Management that is the part in
charge put forward, apply and enforce measures to mitigate the risks and
provide an appropriate level of protection to the consumer. Risk Management
is constituted by a number of tools (that could be regulatory tools, but
there also other tools). HACCP is one of the risk management tools. When the
HACCP-based regulations are issued, they appear in the middle of a number of
other food safety regulations (some of them near-HACCP regulations other on
general hygiene, etc.). The HACCP-based regulation should be coordinated with
the other regulations (risk management tools) and all the food and fish
regulations should be consistent. The result is that even following the same
initial criteria (e.g. Codex Alimentarius HACCP Guidelines) the actual
HACCP-based regulations can differ in practice in their requirements.
Differences in implementation are for instance the most common; as example,
in the case of the EU each exporting country and territory has a de facto MOU
with the EU. In the case of the USA they do not care about to have one with
any single country.
Therefore it is not enough to look only into the 7 principles and the 12
steps to audit HACCP (it is basically a mistake many auditors do). You have
to audit based on the specific regulation and on the specific plant.
Now, after saying all that, in my personal opinion, both the EU and FDA USA
regulations should produce, in general, rather equivalent results (risk
levels for comparable type of products appear from the studies published
rather similar). Conditions for this are the correct implementation of the
HACCP-based regulation and the correct implementation of all the pertinent
regulations (risk management tools) that could apply. What produces the
equivalence is the implementation of the whole set of food/ fish safety
regulations and not just the compliance with the HACCP-based regulations.
(v) Nevertheless, HACCP and SSOP plans are not the same. You can
have consolidated HACCP and Hygiene plans (e.g. adding requirements of both
regulations), but individually (when auditing for each regulation) you will
have to look for the specific requirements of each regulation.
For instance, the EU regulations included spoilage as a hazard (the US FDA
HACCP-based regulation does not)
therefore spoilage should appear as a hazard for the EU regulation (not harm
for the US regulation) if you audit based on the EU regulation. If you audit
based on the US regulation you could skip that. But, do you think you could
export spoiled fish to the USA...?
There is a lot of discussion if fish spoilage could be considered or not a
hazard. At the very end this is in practice irrelevant, for the consumer,
because the US FDA regulations (and local regulations) look into spoilage and
FDA is checking really for spoilage at the port of entry (look at its
detention list).
Very low risk to consume spoiled fish in the USA! Very low risk to consume
spoiled fish imported from the USA in the EU, because USA exporters have to
comply with EU regulations! (they have to provide a certificate, and as a
matter of fact, the USA is in List No 2 of the countries that could export to
the EU!).
Unfortunately we can not assess easily this overall equivalence in all cases,
perhaps it will arrive with the development of Risk Assessment. While this
arrives, the only possibility is to perform HACCP audit separately for each
regulation.
(v) Some time ago I published a paper basically comparing the EU
and the US FDA HACCP-based regulations, because a number of people in
developing countries asked us what to do; finally I put all the notes (like
this one) together and prepared a paper. You may find that paper still
interesting to read. The reference is as follows:
Lupin, H. Producing to achieve HACCP compliance of fishery and aquaculture
products for export. Food Control 10 (1999) 267-275.
Today there are new regulations and new developments and probably I would
have to review the paper, make additions and add up-dated examples. In any
case the HACCP-based regulations they refer to are still valid, and what it
is said about them is correct (new EU regulations would become in force from
January 2006). To analyze and discuss somebody else regulations is arid and
not easy; people (fish/food inspectors) do not like that, and I was a bit
reluctant to prepare the paper. Fortunately criticisms did not arrive and
privately, people from both sides acknowledged that what I had written was
correct.
Next October I have to run with some colleagues a workshop on HACCP Audit in
the fishery industry in the I.R. of Iran, and this helped me as a review.
I hope this would be enough for you and make me to remember all the
details...!
Important final notes:
1 I wrote that in several places, but I just make clear again
that opinions included in this note are my personal opinions and not FAO or
Codex opinion.
2 Regulations (and their interpretations) are evolving, and
rather quickly nowadays. Therefore there is nothing that could replace your
careful own reading and interpretation of regulations and to keep track of
them.
Kind regards.
Hector M. Lupin
Senior Fishery Industry Officer (Quality Assurance)
Fish Utilization and Marketing Service
Fishery Industries Division / FAO of the UN
Viale delle Terme de Caracalla 00100 Rome Italy
Tel.: +39 06 570 56459 Fax: + 39 06 570 55188
E-mail: hector.lupin@fao.org
Please visit our website: http://www.fao.org <http://www.fao.org/>
-----Original Message-----
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf
Of CHARLES DAXBOECK
Sent: 15 September 2004 20:36
To: seafood@ucdavis.edu
Subject: EU regs again
Dear Group :
I have a follow-up question to the one I posed the other day regarding HACCP
"audits" or reevaluations. It goes as follows :
Here in Tahiti, French Polynesia, we have our veterinary inspection service
which will not sign any "health-sanitary" certificate for fish being exported
to the USA if the HACCP plan for the exporting company has not been "audited"
under the verification section of the plan, on a yearly basis and is not
current on the date of export. Such due diligence for USFDA could be
applauded, but neither USFDA, NMFS, nor the US importer needs an EU-style
"health" certificate for fish imports under present regulations. What
everyone does want (and it is of course mandatory !) is a valid HACCP plan
for the particular seafood product being exported, and that's also a matter
of due diligence between the importer to have on record and the exporter to
furnish (or at least relevant monitoring records) such plans. On the other
hand, the same inspection service within our "competent authority", which has
the responsibility of actually assigning EU seafood export agreement numbers,
based on inspection of the facility AND upon inspection and approval of the
adequacy of the individual HACCP plans does not have the same criterion for
reevaluation for the EU. Be reminded here that within these seafood export
plans (for Europe and the USA), under the HACCP principle 6 section
(Verifications) the inspection service has approved the fact that these plans
are "audited" or reassessed at least on an annual basis. Many individual
exporters no longer respect the minimum yearly reassessment of their plan and
therefore are not current, for the most part in their annual "audits". This
seems to me to create an administrative and HACCP implementation problem
because on the one hand, the reassessment in needed for export to the USA
(since the inspector won't sign the health certificate and without this
certificate according to our laws and statutes, you cannot export any seafood
product) but for export to the EU, under the SAME PLAN, and where a health
certificate is in fact needed, the same inspection service now simply states
that no annual "audit" is needed, so the certificates are signed without any
qualms. BUT, the HACCP plans that has been APPROVED by the "competent
authority " to export to the EU AND USA are the same (French and English
versions). Is this not a bit confusing for seafood products exported to the
EU from a LIST 1 Third Country such as French Polynesia ?? Could this in fact
jeopardize our export market simply for a procedural error on the part of our
inspection service ?? My understanding, and correct me if wrong, but HACCP is
the same thing in Europe, the USA, Japan etc. and is still based ONLY on the
standard 12 steps or stages and the 7 principles, with prerequisite
sanitation programs, and GMPs.
I thank you in advance for your insight.
Sincerely,
Charles
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