FEPAS and FAPAS Experience Quality Surveillance of Official Food Analyses in Estonia 19982002

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FEPAS and FAPAS Experience Quality Surveillance
of Official Food Analyses in Estonia 1998-2002

• By Dr. Risto Tanner
• National Institute of Chemical Physics and
  Biophysics, Estonia
• Presentation to the Joint JRC IRMM/CSL Workshop
  on Chemical and Microbiological Proficiency
  Testing of Food Laboratories on the bases of the
  work ordered and funded by the Estonian Ministry
  of Agriculture, contracts No. 194/1998 102/1999
  146/2000 114/2001 144/2002

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Introduction I Inheritance of the Russian time
in Estonia

• 70 small food laboratories with out-of-date
  equipment, narrow choice of analyses available
  and out-of date methods of analyses per 1.5
  millions of population
• 5 different state administrations responsible for
  food analyses (Ministry of Health Protection,
  Ministry of Milk and Meat Industry, Ministry of
  Food Industry, Ministry of Agriculture, Ministry
  of State Purchases)
• No-one of small labs want to be reduced or
  closed, all they competed with each other for
  state funding
• Which lab is good enough to get state support and
  investments? Who is independent and competent
  enough to decide?

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Introduction I I

• In 1995 the new Food Act was adopted by the
  Estonian Parliament and large scale harmonization
  of Estonian food legislation with EU norms was
  started
• In 1995-1996 profound revision of activities and
  analytical facilities of food laboratories in
  Estonia with the aid of Carl Bro Food Inc.,
  Denmark
• In 1996 An amendment to the Food Act adopted
  laying main responsibility for the official food
  control to the Ministry of Agriculture
• Optimization of the network of food laboratories
  began
• In 1996 first food laboratory was accredited with
  the aid of SWEDAC, Sweden to be compatible with
  EN45001
• Competition between leading laboratories for
  state funding and for the status of reference
  laboratory became more acute

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The Ministry of Agriculture look for solution

• In 1998 the Ministry decided to start to buy
  control samples from the Food Analysis
  Proficiency Assessment Scheme (FAPAS, Central
  Science Laboratory, York, UK) and distribute to
  Estonian food labs as control samples
• The National Institute of Chemical Physics and
  Biophysics as an independent third side
  institution was contracted to provide technical
  work

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Multifunctional result achieved

• 1. Exchange of information and distribution of
  advanced experience through competent and
  independent third side institution.
• 2. Data were collected for highest international
  level evaluation of proficiency of Estonian food
  labs, which could not be altered by any local
  political or economic interest.

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Total amount of the work I
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Total amount of the work II
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Example of the summary of results of microbiology
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Year summaries of microbiological results
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Temporary summary of food chemical analyses(some
late results of the year 2003 not yet included)
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2 year year final summary of chemical test
analyses in some selected laboratories and in
total
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Development of the laboratory proficiency from
year to year I
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Development of the laboratory proficiency from
year to year II
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The 2-year summary of check-up analyses of
nutritional components in meat
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The 2-year summary of check-up analyses of
veterinary drugs in animal products
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Year summary of analyses of pesticide residues
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In total 19 different matrixes and 71 different
pesticide residues were analysed.
Year by year distribution
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Mean values Z of individual pesticide residues
73 total, from these for 23 \z\gt2 (31.5)

• Procymidone 2.01
• Tecnazene 2.03
• Monocrotophos 2.04
• Trans-chlordane 2.23
• alfa-Endosulfan 2.29
• Heptachloroepoxide 2.37
• Fenarimol 2.42
• cis-chlordane 2.5
• Bifenthrin 2.59
• Deltamethrin 2.62
• Oxy-chlordane 2.78
• Chlorpyrifos 2.84
• Dichloran 3.13
• Chlorpyrifos 3.17
• Phosalone 3.58
• Dieldrin 3.67
• Metalaxyl 3.7
• Carbaryl 3.76
• Oxadixyl 4.04

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The 2-year summary of check-up analyses of
aflatoxins in two laboratories
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What conclusions may be done from the data
concerning this triangle of mutual influences?
Responsible Authority
Quality of analyses
Accreditation Body
Laboratory
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Discussion I. Accreditation point of view

• What about legislation concerned?
• Perhaps the procedure of assessment of the
  conformity of food labs to the standard 17025
  needs to be reviewed and improved?
• May be requirements for licensing of food labs
  must be reviewed and AC authorized to perform
  special conformity assessment to licensing
  requirements of food labs?

• Must Estonian Accre-ditation practice be reviewed
  and improved?
• Results of this inves-tigation were discussed in
  the Steering Committee of the Estonian
  Accreditation Centre and correction measures are
  just being planned.

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The Accreditation Center

• They have sent us good reports of corrective
  activities every time they have got bad result
• EA-2-10 recommend minimum 1 PT per 4 years
• They rejected two of our best experts, the third
  accepted by them was not familiar with this
  concrete analytical method

Discussion I
Isnt there a contradiction between the spirit of
voluntarity of the standard 17025 and its
compulsory implementation?
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Discussion II. The Ministry point of view

• COUNCIL DIRECTIVE 93/99/EEC
• the laboratories comply with the general
  criteria for the operation of testing
  laboratories laid down in European Standard EN
  45001
• In assessing .Member States shall (a) apply
  the criteria laid down in European Standard EN
  45002 andb) require the use of proficiency
  testing schemes as far as appropriate.
• assessment .bodies shall comply with the
  general criteria for laboratory accreditation
  bodies laid down in European Standard EN 45003.

• We are fond of democracy, all the system of
  accreditation has been built up on the principle
  of voluntarity. May be it is not the best way for
  consumer protection in the food area? May be it
  would be better to establish special procedure
  for official assessment of conformity in
  compulsory area and stronger requirements
  (amendment of the Directive)?
• Is there low level of administrative capability
  of the Ministry in the question??? In August 2003
  in total 34 legislative acts in Estonia
  established compulsory accreditation

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The Ministry of Agriculture

• The only requirements for licensing according to
  the Food Act of Estonia are accreditation and
  successful participation in proficiency tests
• We are not specialists in the technical field, we
  cannot stop license if accreditation status is
  not stopped

Discussion
Well, but international proficiency tests provide
you a simple instrument not requiring profound
technical knowledge, can it be better documented
in licensing requirements?
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Discussion III. The laboratory point of view

• Too scarce state funding causes dramatic
  consequences for us
• 1. Low salary level do not motivate analytical
  staff, good specialists have left our laboratory
• 2. Proficiency test samples and reference
  materials are very expensive, we cannot buy them
  ourselves
• 2. We are in great hurry because we must earn up
  to 50 of our budget with paid analyses to
  private sector the hard work loading do not
  support high quality

May be something is wrong in arrangement of the
market of analytical services in Estonia? Pricing
of paid analyses by official laboratories is not
uniformly regulated in Estonia and, competing
with each other, official labs sell too cheap
analyses private laboratory activity is not
possible in these circumstances
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Discussion IV. Reference laboratories

• CONSOLIDATED VERSION OF THE TREATY ESTABLISHING
  THE EUROPEAN COMMUNITY Article 87
• 1.   Save as otherwise provided in this Treaty,
  any aid granted by a Member State or through
  State resources in any form whatsoever which
  distorts or threatens to distort competition by
  favouring certain undertakings or the production
  of certain goods shall, in so far as it affects
  trade between Member States, be incompatible with
  the common market.

• NICPB obliged not to sell food analyses concerned
  on the market of private services in connection
  with the investigation presented.
• NICPB can not function as reference lab in spite
  of its technical experience because it as
  scientific institution do not routine work and is
  not accredited.
• Now reference labs nominated by the Ministry
  appear to be favored competitors to others on the
  market of private services (some ref labs cover
  nearly 50 of its budget with paid analyses to
  open market! How to avoid conflict of interests?
  Is it compatible with principles of free
  market?)?

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The laboratory point of view II
Re-arrangement of the market of analytical
services involving private investments? Estonian
market of testing services is very small
(compared to high productivity of modern
equipment). In small country it is not reasonable
to maintain national laboratories for relatively
small number of official tests. It would be more
practical to reform most of labs into
institutions in private law and order necessary
tests for the national surveillance in compulsory
area as state procurement on contracting bases,
on the economically equal ground with private
clients of laboratories! International level
proficiency test samples distributed by
authorities could provide an effective and simple
instrument for proficiency surveillance in those
conditions.
Abundant funding the best OK! But Estonia has
achieved quick development of its economy and
welfare by means of lowering of taxes. Low lever
of legal expenses is the price we are paying for
quick development.
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Proposals for further discussion as conclusion

• Small member state like Estonia needs flexible
  network of laboratory services on the common
  ground for both paid and official analyses of
  both food and environment samples for effective
  use of expensive laboratory facilities. It would
  be desirable if EU legislation were flexible
  enough for regulation of activities of such
  network.
• The balance between accreditation and proficiency
  testing needs to be regulated better, compulsory
  proficiency tests may provide good alternative to
  compulsory accreditation for quality surveillance
  of official food control analyses.
• Technical work concerning surveillance needs to
  be separated from routine analytical work, e.g.
  national institution of applied research as JRC
  contact points might be authorized to control
  quality of analyses on the common ground in both
  environment and food sectors.

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Thank You for Your Kind Attention!