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Monitoring of the Progress toward Sustained Elimination of
               Iodine Deficiency in Romania


         Report of a Technical Assistance Mission


                 Romania, 6-12 April 2003


                           Jacky Knowles, PhD

            International Micronutrient Malnutrition Prevention
                    and Control (IMMPaCt) Programme
                 Centers for Disease Control and Prevention
                                Atlanta, USA.
EXECUTIVE SUMMARY

In recognition of continued national prevalence of iodine deficiency, and of its impact on
intellectual development and future school performance of newborns in the country, the
Romanian Government has recently committed to Universal Salt Iodisation (USI). Legislation for
USI came into effect in January 2003 and there is now an urgent need to strengthen national
capacity to monitor national progress in sustained elimination of iodine deficiency.

UNICEF Bucharest requested technical assistance from the International Micronutrient
Malnutrition Programme at the U.S. Centers for Disease Control and Prevention to support these
efforts by assessing existing national monitoring capacity, and providing advice on improving
systems for monitoring iodised salt quality and availability and for monitoring progress in iodine
nutrition of the population. The main findings and recommendations of the mission were as
follows.

Iodine Deficiency is a Nationwide Problem but Romania is Now Well-Positioned to Successfully
Eliminate it Forever

Low iodine intake of pregnant women in Romania means that each generation of newborns is
suffering some degree of brain damage from iodine deficiency, limiting their future educational
ability and productivity and thus the future socio-economic growth of the nation.
Diagnosis and treatment of iodine deficiency-related thyroid pathologies are also creating an
unnecessary burden on national health care services
Proven national capacity exists for assessment of iodine nutrition through measurement of urinary
iodine, although national resources for this are not secure. Assurance of the quality of urinary
iodine assessments should be strengthened through collaboration with one of the International
Resource Laboratories for Iodine (IRLI) in Europe.
Management and oversight of national progress in sustained elimination of iodine deficiency
should focus on monitoring trends in iodine nutrition in pregnant women during the early part of
pregnancy. This data will provide valid information on national progress toward the protection of
developing foetal brains from iodine deficiency, confidence from proven national success, and a
sound basis for future adjustment to salt iodine levels as and when needed.

To obtain timely national reference data to capture the effect of staged USI and to provide a
baseline for longer term monitoring of iodine nutrition in the population a comparative study of
household iodised salt use and its relation to iodine nutrition in pregnant women and in
schoolchildren should be conducted within the next year.

There is High Potential for Achieving Universal Consumption of Quality Iodised Salt
Five of the salt mines of the national salt company SALROM have the capacity to produce
quality-assured iodised food grade salt in amounts sufficient for the population of Romania.
Monitoring food grade salt at production and import should be the main focus of national efforts
to assure the quality of the iodised salt product.

Technical capacity and capability exists for quality assurance at production, and for control of
this quality by the local food and hygiene department. Current procedures for both these functions
need strengthening in line with their respective responsibilities to comply with and enforce the
new legislation.



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Additional monitoring of iodised salt at retail outlets will help build national confidence in the
quality and sufficiency of both domestically produced and imported products available to
consumers.

Authority for monitoring imported iodised salt and, from January 2004, for monitoring salt for the
human and animal food industries, needs to be defined.

Monitoring for Effective Management of National Efforts for Sustained Elimination of Iodine
Deficiency
It is recommended that frameworks for monitoring progress in iodine nutrition of the population
through USI be developed with emphasis on obtaining the minimum information required for
effective assessment of national progress and for making necessary programme management
decisions.

An independent centre, with secure financial resources, is recommended to be responsible for
continuous data management, regular information-sharing and periodic public reporting.

A large number of different partners are involved in national efforts toward sustained progress in
iodine nutrition in Romania, many of whom have potential roles to play in monitoring either the
product, process or impact of these efforts. Effective coordination of these different groups and
information-gathering systems will be the challenge for successful management, increased
national-ownership and sustained oversight of progress.

Official-recognition of a planned national alliance of all partners with accountability to the Prime
Minster’s or President’s office will be an important step toward reaching sustained national
progress in iodine nutrition by the year 2005, a goal which is highly achievable in Romania.

Next Steps
It is recommended that upon acceptance of the analysis in this report:
 Romania should
      Co-ordinate a Working Group for Monitoring, under the structure of the national alliance,
          to develop a framework for monitoring and reporting on the quality and availability of
          iodised salt and national progress toward sustained elimination of iodine deficiency.
      Develop detailed short and long term action plans to implement the steps of the
          framework, including identification of training needs and financial and personnel
          resources that will be required.
      Begin implementing these action plans as soon as possible.

   UNICEF Bucharest should
     Provide a strong supporting role for the activities above, while reorienting assistance
       toward national ownership and assured permanence of national progress toward
       elimination of iodine deficiency.

   CDC/IMMPaCt will
     Be willing to provide additional technical expertise to support the national development
      and implementation of an effective monitoring system.




                                                                                                  3
                                                               TABLE OF CONTENTS
EXECUTIVE SUMMARY .......................................................................................................................... 2
AIMS OF THE TECHNICAL ASSISTANCE MISSION BY THE U.S. CENTERS FOR DISEASE
CONTROL AND PREVENTION ............................................................................................................... 5

I.        INTRODUCTION ................................................................................................................................ 6

II.          BACKGROUND ............................................................................................................................... 8

     1.      RECOGNITION OF IODINE DEFICIENCY DISORDERS.............................................................................. 8
     2.      HISTORY OF INTERVENTIONS TO ELIMINATE IODINE DEFICIENCY....................................................... 8
     3.      CURRENT LEGISLATION FOR UNIVERSAL SALT IODISATION................................................................ 9
III.         GENERAL FINDINGS FROM THE MISSION ..........................................................................10

     1.      IODISED SALT SITUATION ...................................................................................................................10
     2.      IODINE NUTRITION OF THE POPULATION ............................................................................................12
     3.      IMPACT OF IODINE DEFICIENCY ON THE POPULATION ........................................................................13
     4.      POLICY ENVIRONMENT ......................................................................................................................15
IV.  EXISTING NATIONAL CAPACITY FOR MONITORING PROGRESS TOWARD THE
ELIMINATION OF IODINE DEFICIENCY THROUGH SALT IODISATION ................................16

     1.      PRODUCT (SALT) MONITORING ..........................................................................................................16
     2.      PROGRESS IN IODINE NUTRITION (IMPACT) MONITORING ..................................................................19
     3.      THE QUALITY OF THE PROCESS ..........................................................................................................20
V.           RECOMMENDATIONS ................................................................................................................23

     1.      PRODUCT (SALT) MONITORING ..........................................................................................................23
     2.      IMPACT/PROGRESS MONITORING .......................................................................................................28
     3.      ADDITIONAL RECOMMENDATIONS RELATED TO ASSURING SUSTAINED ELIMINATION OF IODINE
             DEFICIENCY THROUGH USI IN ROMANIA. ..........................................................................................32
     4.      NEXT STEPS .......................................................................................................................................33
ANNEXES ....................................................................................................................................................34




                                                                                                                                                               4
AIMS OF THE TECHNICAL ASSISTANCE MISSION BY THE U.S. CENTERS FOR
DISEASE CONTROL AND PREVENTION

Romania has committed to achieve sustainable national elimination of iodine deficiency through
mandatory Universal Salt Iodisation (USI). Legislation for USI came into effect in January 2003
and there is now an urgent need to strengthen national capacity to monitor national progress in
sustained elimination of iodine deficiency.

A mission from the IMMPaCt program at the U.S. Centers for Disease Control and Prevention
travelled to Romania from 6-12th April 2003 to support these national efforts through:
     Assessing the existing national monitoring capacity
     Providing feedback and advice on improving systems for monitoring iodised salt quality
      and availability and for monitoring progress in iodine nutrition of the population

This report of the mission is made up of five parts.

     The first three parts give the aim of the mission, an introduction to monitoring within the
      context of overall national efforts for elimination of iodine deficiency, and background to
      the current situation of iodine nutrition in Romania.

     Parts IV and V describe findings from the mission and an assessment of current national
      capacity to monitor progress in iodine nutrition.

     Part VI contains recommendations on the type of monitoring systems and their
      implementation in the context of existing national capacity.

  The agenda and a list of people met during the mission is attached as annex 1.




                                                                                               5
             I. INTRODUCTION

Increased awareness over the past two decades of the consequences of iodine deficiency on the
intellectual development of the population, and of the ability to eliminate this deficiency through
universal salt iodisation has stimulated national leaders in many countries to act. The introduction
of universal salt iodisation (USI1) in country after country is resulting in striking increases in the
numbers of newborns in the world being protected against brain damage from iodine deficiency2.

Iodine deficiency disorders (IDD), including the brain damage that occurs in the developing
foetal brain when an expectant mother is iodine deficient, are the consequences of insufficient
iodine intake through the common diet due to lack of iodine in the soil and water. Therefore, once
adequate iodine nutrition is achieved through the delivery of additional iodine from iodised salt in
the daily diet of the population, the practice must be maintained forever. IDD elimination is not a
time-limited effort.

Heads of State and Government from around the world signed the document at the World Summit
for Children in 1990, which included a commitment to the virtual elimination of IDD, a goal
which was renewed at the U.N. Special Session for Children in May 2002, with emphasis on
achieving sustainable elimination of IDD by 2005. These agreements imply national commitment
not only to eliminate IDD within the next 3 years, but to create the societal acceptance of
universal salt iodisation along with an infrastucture to provide permanent oversight of iodine
nutrition.

Sustaining the elimination of IDD requires continued assurance, through monitoring, of the
quality of combined national efforts. In this report the different areas of monitoring will be
described as:
   Product monitoring – assuring the quality and quantity of iodised salt production, so that
      iodine levels in salt are always adequate for assured iodine nutrition of the population, and
      that there is constant assurance of a sufficient and fairly-priced supply of this product for
      the whole population.
   Progress or impact monitoring - assurance of permanent progress in human iodine nutrition
      to confirm that elimination of IDD is achieved and sustained
   Process monitoring – assurance of the quality of the many elements involved in support of
      USI and elimination of iodine deficiency.

Process monitoring includes assessment and analysis of commitments and efforts in management
of political, infrastructure, human and financial resource development, of communication efforts,
oversight methods etc. There is less international experience available in the field of nutrition
with the type of methodology and tools to monitor this aspect of the national iodine nutrition
efforts and it will therefore not be given as much attention as the other two areas in this report.

Assuring the quality and sufficiency of iodised salt and of the progress in iodine nutrition requires
a solid national monitoring system with periodic public reporting, to allow for review and
renewal of commitments by national leaders when and where necessary, as well as public
accountability.


1
 UNICEF-WHO Joint Committee on Health Policy Special Session. 1994. WSC Mid Decade Goal Iodine
Deficiency Disorders.
2
    USI Scorecard at http://www.sph.emory.edu/iodinenetwork/SCORECARD/index.html


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Currently, the iodine nutrition status of a population is often approximated by special surveys of
schoolchildren. Although it may be convenient to take measurements and samples from this
group, results of these assessments will not necessarily be representative in each situation of the
iodine nutrition of all other groups in the population, especially pregnant and lactating women
who are known to have higher iodine requirements (200-220g per day during pregnancy,
compared with 90-120g per day for school-aged children).3

Inadequate iodine nutrition during early pregnancy reduces the density of the network of
interconnections being formed among the brain cells in the developing brain of the foetus4,
limiting the intellectual ability of an individual for life. At a population level, the consequence
has been shown to be a 10-15% lower average intellectual quotient (IQ)5. Adequate iodine status
during the early stages (up to 16-18 weeks) of pregnancy6 is thus crucial to eliminating the effects
of iodine deficiency from a population.

The susceptibility of the developing foetal brain to damage from iodine deficiency and the fact
that pregnant women have the second greatest requirement (after lactating women) for iodine
mean that it would be most appropriate to focus monitoring efforts on pregnant women in order to
ensure optimal protection of the developing foetus from low iodine intake.

The prevalence of goitre has been used to indicate the existence of iodine deficiency in Romania,
however it is not recommended as an indicator to assess progress in iodine nutrition of the
population. Once salt in a country is being iodised and iodine nutrition is improving, goitre
becomes an unreliable indicator to monitor iodine intake and the elimination of iodine
deficiency7.




3
  WHO/UNICEF/ICCIDD Assessment Of Iodine Deficiency Disorders And Monitoring Their Elimination.
A Guide for Programme Managers. 2001. WHO Geneva Doc. WHO/NHD/01.1
Food and Nutrition Board (FNB), Institute of Medicine (IOM). Dietary Reference Intakes for Vitamin A,
Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon,
Vanadium, and Zinc (2002)
4
  Stanbury, JS (Editor):The Damaged Brain of Iodine Deficiency. Cogn. Comm. Corp., Philadelphia, 1994
5
  Morreale de Escobar, G et al. Is Neuropsychological Development Related to Maternal Hypothyroidism or
to Maternal Hypothyroxinemia? J. Clin Endocrinol. Metab. 2000; 85: 3975-3987
6
   Xue-Yi C, Xin-Min J, Zhi-Hong D, Rakeman MA, Ming-Li Z, O’Donnell K, Tai M, Amette K, DeLong
N and DeLong GR: Timing of vulnerability of the brain to iodine deficiency in endemic cretinism. N Engl J
Med 1994;331:1739-44
7
  WHO/UNICEF/ICCIDD reference, as footnote 3


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            II. BACKGROUND

Romania has a total population of 22.5 million distributed over 41 judets (districts) and the
Municipality of Bucharest. Romania is located in Eastern Europe, bordered by Ukraine, Hungary,
Moldova, Bulgaria and Federal Republic of Yugoslavia (see map in annex 2). IDD has been
recognised in the northern and central regions of the country for over 50 years however the
different interventions introduced during that time have failed to make sustainable improvements
in iodine nutrition of the population in these, and other, areas of the country.

In 2002 however, new legislation was passed mandating iodisation of all table salt from January
2003 and of all salt for human and animal consumption from January 2004. The country is now in
a good position to make significant progress in human iodine nutrition by 2005 and, through the
creation of an effective national coalition, to plan for and overcome the recently-recognised
challenges which face sustained progress.

The following sub-sections give an overview of the history of IDD and its elimination in
Romania over the past 50-60 years.

1. Recognition of Iodine Deficiency Disorders

       Iodine deficiency has been recognised in at least some areas of Romania since 1947 when
        the first epidemiological study of goitre was conducted. Subsequent studies in the 1970’s-
        90’s confirmed these initial findings, with levels of goitre between 35% to 60% reported in
        the mountainous regions of the country.

       In 1991, urinary iodine was measured in 2,018 urine samples from schoolchildren in 30
        judets. The overall median urinary iodine excretion was 58g/l. Only three judets had
        median urinary iodine excretions above the WHO/UNICEF/ICCIDD recognised minimum
        cut off for adequate iodine nutrition in this population group (> 100ug/l).

       The C.I. Parchon Institute of Endocrinology monitored urinary iodine in children aged 6-16
        years over the period 2000-2002 and found median urinary iodine levels in these children
        were below normal (<100g/l) in 21 of 27 judets studied (overall median not available).

2. History of Interventions to Eliminate Iodine Deficiency8

       In 1949 a decision was made to administer potassium iodide tablets to children and
        pregnant women in mountainous areas.

       In 1962, as a result of Government decision HG 1056/1992, sale of iodised table salt (8.8-
        14.7ppm iodine) was introduced in 30 judets considered to be endemic for goitre, however
        non-iodised salt was also still available.

       In 1995, Government decision HG 779 stipulated that table salt should be iodised at a level
        of 40-50ppm KIO3 (23.5-29.5 ppm iodine), and widely available for retail throughout the
        country (permissive legislation). This decision prohibited the use of iodised salt in the food
        industry and mandated that labelling of iodised salt should contain a warning against its use
        for food preservation (pickling), contraindications for its use by people with certain thyroid

8
    From Background document accompanying Government Decision 568/June 5, 2002.


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        conditions and a six month shelf-life expiry date9. In addition, this decision stated that the
        interests of the only Romania salt producer, SALROM, should be protected.

The interventions above did not appear to either achieve or sustain adequate dietary iodine
nutrition for the population of Romania, as shown by monitoring of urinary iodine in children
aged 6-16 years over the period 2000-2002 by the C.I. Parchon Institute of Endocrinology (above
section on Recognition of IDD).

3. Current Legislation for Universal Salt Iodisation

       Government Decision HG 568/June 5, 200210 stipulated universal iodisation, at a level of
        20 + 5ppm iodine (in the form of KIO3 or KI), of all food grade salt11, including salt for use
        in the food industry and for animal husbandry.
        The legislation allows for phased introduction of the mandatory regulations, applying to
        table salt only from January 2003 and to all salt for human and animal consumption from
        January 2004.
        Requirements for labels to contain the above warnings, contraindications and shelf-life
        expiry dates were not included in this decision.




9
   G. Gerasimov. Status of IDD Control and Elimination Program in Romania: A Step Away From
Universal Salt Iodization, June 2000.
10
   See annex 2 for copy of legislation HG 568/June 5, 2002
11
   Codex STAN 150-1985, Amend. 2-2001


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            III. GENERAL FINDINGS FROM THE MISSION


1. Iodised Salt Situation
         Iodised salt is currently being produced domestically in amounts which appear
          sufficient to cover the national market for table salt, however this has not yet resulted
          in iodised salt use by 100% of households. In 2002 iodised salt was found in
          approximately 53% of households nationally.
         The use of iodised salt in the food industry was previously prohibited, however its
          voluntary use, especially in fish canning and bread baking industries, is already
          increasing12 prior to mandatory use in these and other food products from January
          2004.
         Salt for animal husbandry is produced in three forms: loose salt in bags; salt blocks,
          which would not be possible to iodise; and as pressed blocks of salt and mineral mixes,
          which apparently contain iodine13.

a) Production level
The National Salt Company of Romania – SALROM14 - is defined as a joint stock company with
State-owned capital (although state-owned it is administered like a private company with no state
benefits or finance9). SALROM estimates the domestic salt market to be approximately 80,000
MT salt per year (based on a population size of 22.5 million and using the calculation of 3.5 kg
salt/person/year). The actual amount of iodised salt produced and sold as table salt for the
domestic market as well as for other uses over the past few years is unclear. Some details of what
has been reported are given below.

     i.   According to a 1999 national salt situation analysis, Romania produced around 2 million
          metric tonnes of salt in 1998, about 10% of which was food grade salt15. In the first 5
          months of 1999 about 30% (43,000 MT) of all food grade salt was reported to be iodised.
     ii. According to the 2003 note from SALROM10 however, only 26,000 MT of iodised salt was
         sold as table salt during the whole of 1999, this was equivalent to 24% of the total table salt
         market for that year. The discrepancy in figures from the two reports may be due to
         differences in what was reported, for example, reporting of total iodised salt production
         (possibly for other food uses, or for export) versus total iodised salt sold for the domestic
         table salt market but this was not discussed during the mission.
     iii. From the same SALROM 2003 note, only 8,000 MT iodised table salt (approximately 20%
          of the total domestic table salt market quoted) was sold by SALROM during the first 6
          months of 2002.


12
   Personal communication, Director Targu Ocna mine in Bacau
13
   The Romanian Universal Salt Iodization Plan for 2002-2003, Lorenzo Rossi, UNICEF Romania, April
2002.
14
   See annex 4 for details of SALROM company, mines and production of iodised salt since 1998


15
     Codex STAN 150-1985, Amend. 2-2001




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     iv. During meetings with the Technical Manager and Quality Inspector of SALROM it was
         stated that:
             the 5 SALROM mines producing salt for human consumption already had the
              capacity to produce a total of 80-90,000 MT of iodised salt for human consumption
              per year.
             all table salt produced by SALROM mines since January 2003 has been iodised
              according to the national standard of 20ppm iodine.
             approximately 80,000 MT of unpackaged salt for human consumption was imported
              from Belarus and Ukraine, an unknown amount of which was iodised16.
     v. The director of Tg. Ocna mine in Bacau, said that about 50% of all iodised salt currently
        being produced by the mine goes to the food industry, mainly for fish canning and bread
        production. Figures for the sale of iodised salt to the food industry by other mines in
        Romania were not available.

The Ministry of Health, Institute of Public Health Bucharest, Food Hygiene Department’s 2001
annual report on the quality of iodised salt at production and retail17 mentions that of 233 iodised
table salt samples collected directly from 5 SALROM mines during the year, 97% had iodine
levels above the then national standard of 23.5-29.5 ppm iodine. This high percentage of samples
within the national standards does not correlate with monitoring results from salt at retail outlets
(see Table 1 and section V-1 for additional comment on these results). Only 3 samples were
collected from the mine at Cacica and all of these 3 had iodine level below the nationally
regulated level at production.

There is a salt mine at Praid in Harghita judet which produces salt licks for animals in the form of
pressed blocks of salt mixed together with vitamins and minerals apparently including iodine18.
Salt from this mine is not currently included in the Institute of Public Health reports.

b) Retail level
The same 2001 report from the Institute of Public Health states that 71% of a total of 1,771
iodised table salt samples collected from retail outlets in 38 judets throughout the year contained
> 40 mg ppm KIO3 (23.5ppm iodine). Information on the source of salt was included in the report
and a summary of results is given in Table 1.

Samples originating from four of the country’s salt mines: Slanic Prahova, Ocna Dej, Targu
Ocna, and Ocna Mures all had around the same percentage of samples (25-27%) with less than
23.5ppm iodine, however 64% of salt samples produced at Cacica mine had levels of iodine
below the 1995 national standard of 23.5ppm iodine which was in place at that time (Note - The
purpose of the 2001 data collection was to report on the iodine level of table/cooking salt samples
which were labelled and sold as iodised salt, and not to assess the overall proportion of
table/cooking salt on the market which contained iodine).




16
    There is no record of iodised salt exports from Ukraine to Romania in the 2002 report “Iodized salt –
Situational analysis in Ukraine”. Directorate Executive of the Ukrsil Association.
17
   Synthesis. Iodine Content in Edible Salt On Sale. Institute of Public Health Bucharest. 2001
18
   See footnote 13 (Rossi report)


                                                                                                      11
Table 1. Summary of iodine levels in iodised table salt collected at retail outlets during 2001

          Source           #           Average        % samples      % samples      % samples
          Salt Mine        samples     iodine         complying      below          over
                                       content        with           23.5ppm        29.5ppm
                                       (ppm)          regulations*
      Slanic           654             24.3           59.2           24.7           16
      Prahova
      Ocna Dej         581        24.6         44.6                  26.3           29
      Ocna Mures       262        31.9         32.8                  27             40
      Cacica           149        22.4         34.2                  64.4           1.3
      Targu Ocna       93         29.2         54.8                  24.7           20.4
      TOTAL                       25.6         48                    29             23
*National standard in 2001 was 23.5-29.5 ppm. HG 779/1995

c) At household level
Results from a 2002 national survey of 1,810 households which was coordinated by PSI19,
showed that 53% of households had iodised salt available however more than one type of salt
was found in most (70%) of households, with different grain type according to the intended use of
the salt. 67% of all refined salt samples (used as table and cooking salt), 4% of all large grain
samples (used for cooking and pickling) and 0% of all block salt (used for animal feed) were
found to be iodised. (Testing was done using the MBI kit – it is not clear from the report whether
positive results were based on any colour change (>0ppm iodine) or on a degree of colour
change indicating >15ppm iodine. It is also not clear whether kits for potassium iodide, KI,
rather than for potassium iodate, KIO3, were used to test Greek salt samples, which are known to
contain KI). The 2002 PSI report also mentions that household use of iodised salt is greater than
the national average in the south, south-west, central and western areas of Romania.

The 2003 preliminary report from the Institute of Mother and Child Care of the national study of
iodine nutrition and use of iodised salt and potassium iodide tablets in schoolchildren states that
63.7% of the children’s mothers reported using iodised salt at home (no qualitative or
quantitative testing was conducted to check this).


2. Iodine Nutrition of the Population
        Iodine deficiency is prevalent nationwide.
        Recent national data on iodine nutrition of school-age children has been collected
         which could be used as a baseline from which to monitor the impact of USI in this
         population group.

Urinary iodine levels in schoolchildren, measured by the C.I. Parchon Institute of Endocrinology
in certain judets since 1991, have confirmed the continued existence of widespread iodine
deficiency in Romania (see section III-1).

The C.I. Parchon Institute of Endocrinology also collected information on iodine nutrition in
pregnant women in 2002 (no information on sampling methodology or on trimester of pregnancy

19
     Iodine Deficiency Disorder Research Results and Communication Strategy, PSI August 2002.


                                                                                                12
was available). In urine samples from 1,006 pregnant women, the median iodine level ranged
from approximately 30 to 65 g/l in the 12 judets where samples were taken (no overall median
available).

In 2003, the Institute of Mother and Child Care conducted studies of urinary iodine excretion
(UIE) in 2,097 schoolchildren, 7-8 years old, in the municipality of Bucharest and in 22 (out of
41) judets throughout the country20. In addition to collection of urines, mothers of the study
children were asked about use of iodised salt at home and whether the child had received
potassium iodide tablets or thyroid hormone treatment (not clear whether this was recent use or
ever during their lifetime). Sample selection was done using a multi-stage random sampling
design based on known prevalence of iodine deficiency (with over-sampling in iodine deficient
regions), on proportion of live births and on urban/rural location.

             The overall median UIE nationally was 64g/l, which is below the internationally-
              accepted minimum cut off of 100g/l for adequate iodine nutrition in schoolchildren, thus
              indicating continued iodine deficiency. Significantly better iodine nutrition was found in
              children from urban areas (median UIE of 72g/l) than in children from rural areas
              (median UIE of 60g/l), but even then, the better off group was iodine deficienct by
              International standards.

             The median iodine level in children in Bucharest and in three judets was > 100ug/l,
              however in one of these judets, over 70% of the children were reported to have received
              potassium iodide tablets.


3. Impact of Iodine Deficiency on the Population
            Iodine deficiency impairs the intellectual development and future school performance
             among newborns in Romania
            Iodine deficiency creates an unnecessary burden on national health delivery services

a) Impact on intellectual development
Inadequate iodine nutrition during pregnancy limits the supply of maternal thyroid hormone
(especially thyroxine - T4) to the foetus, which may affect the neurological development of the
rapidly forming foetal brain. Maternal hypothyroxinaemia (low T4, with or without low TSH),
especially when it occurs during the critical period of foetal brain development in early
pregnancy, has been associated with increased risk of impaired psychomotor development 21 and
subsequent reductions in IQ by 10-15 points22.The degree of brain damage depends on the
timing23 and severity of the impact of low maternal T4 on the developing foetal brain.

In Romania, assuming an annual birth rate of around 240,000 and that between 53-64% of
households are using iodised salt, it can be calculated that between 86,400 and 112,800 babies
each year are presently born unprotected against the brain damage of iodine deficiency.

20
   Preliminary report, Anaemia and Iodine in the 7 year old Child, IOMC Bucharest 2003.
21
   Low Maternal Free Thyroxine Concentrations During Early Pregnancy Are Associated With Impaired
Psychomotor Development In Infancy. Clin Endocrinol 1999; 50: 149-155
22
   Morreale de Escobar, G et al. Is Neuropsychological Development Related to Maternal Hypothyroidism
or to Maternal Hypothyroxinemia? J. Clin Endocrinol Metab. 2000; 85: 3975-3987
23
   Xue-Yi C et al. Timing of vulnerability of the brain to iodine deficiency in endemic cretinism. N Engl J
Med 1994;331:1739-44.


                                                                                                        13
The 2002 studies by the C.I. Parchon Institute of Endocrinology on iodine nutrition in pregnant
women (IV-2 above) indicate that iodine deficiency is highly prevalent in this group of the
population, which would also be expected from the level of iodine deficiency among
schoolchildren. As indicated above and in the background section, low iodine intake of pregnant
women in Romania means that each generation of newborns is suffering some degree of brain
damage from iodine deficiency, limiting their future educational ability and productivity and thus
the future socio-economic growth of the nation.

b) Impact on health care costs
Cost estimates from the C.I. Parchon Institute of Endocrinology24 demonstrate that the continued
prevalence of iodine deficiency in Romania constitutes a significant economic burden on the
health sector. This report details costs for urinary iodine analyses, thyroid ultrasound, TSH and
anti-TPO antibody analyses and potassium iodide treatment in children and pregnant women,
with the additional costs for free T4 and T3 treatment in pregnant women. A summary of some of
the costs for diagnosis and treatment of thyroid pathology by the national Institute of
Endocrinology in 2002 is given in Table 2.

Another report from the Institute of Endocrinology25 states that 70% of work for the network of
Endocrinologists which operate in 40 judets is related to thyroid pathology. As part of this, 1,500
patients underwent surgery for thyroid nodules, carcinoma, goitre and Graves disease in 1999
(costs for this type of surgery were not quoted in the report)

Table 2. Financial estimates of health care costs in 2002 (figures for costs are incomplete)

      Treatment                   Cost (USD per         Number of            Total Cost
                                  Treatment             Patients             (USD)
      Ioduria                     3.2                   6,685                21,392*
      Thyroid Ultrasound          6                     ?                    ?
      Hormone Prophylaxis         20                    1,680                33,600
      Potassium Iodide            0.004?                340,487              1,360
      Surgery                     ?                     1500                 ?
      TOTAL                                                                  56,352
                                                                             plus missing costs

     *additional costs for other patients were covered by local healthcare funds in individual
     judets and are not reported here




24
   Report on activities and costs of the sub-programme “Endemic Goitre – Prophylaxis and Prevention of
Complications” from the C.I. Parchon Institute of Endocrinology to Ministry of Health and Family, General
Dept of Health Care and Programmes, 2002
25
   Actual IDD Situation in Romania, by the C.I. Parchon Institute of Endocrinology


                                                                                                      14
4. Policy Environment
     There appears to be strong national ownership of efforts to eliminate iodine deficiency
      through USI in Romania, with leadership from both the Presidential and Prime
      Minister’s councils
     There is political will to create an effective national alliance of all partners.

Significant political will was demonstrated during a one day national conference on IDD/USI
“Salt Iodination: Such a little thing…such a big benefit” which was held in Bucharest in April
2002, with support of the Government and Presidency of Romania, Kiwanis International,
UNICEF and WHO. This conference brought together national decision makers to decide upon
appropriate legislation for universal salt iodisation (USI) in Romania and to establish policy on
how best to implement, monitor and report on the legislative development process and on
enactment of the proposed law.

In follow up to this, in his address to the May 2002 Special Session of the UN General Assembly
on Children, President Iliescu stated that Universal Salt Iodisation would be implemented in
Romania by the end of 2003. This remark was positioned as part of his overall speech focused on
the key factors of “renewed political commitment and adequate allocation of resources..…..for
the steady and complete implementation of our [World Summit for Children 1990] agreed
objectives”.

Comprehensive legislation for phased introduction of USI is detailed in Government Decision
HG 568/June 5, 2002 (see annex 3). This decision stipulates staged requirements for universal
iodisation (at a level of 20 + 5ppm iodine) of all food grade salt, both as table salt (from January
2003) and for use in the food industry and for animal feed (from January 2004).

Plans are underway to convene a second national conference (possibly by the end of May 2003?),
again with support from the Prime Minister’s and President’s councils, to establish a national
alliance of all partners involved in implementation, monitoring, reporting and supporting the
national effort to eliminate iodine deficiency through Universal Salt Iodisation, and to agree on a
strategy for drafting a national action plan to achieve and sustain national progress in iodine
nutrition.

There appears to be high desire among national partners and in UNICEF, of the need for national
ownership and oversight of the product (iodised salt), the process (political commitment,
assurance of financial and trained personnel resources, communication, education and an
effective monitoring infrastructure) and of progress/impact (assured iodine nutrition of the whole
population).

The favourable policy environment encompasses many partners, with the lead being taken by the
Ministry of Health and Family. It is expected that UNICEF, along with other international
organisations, would provide a strong supporting role, while fostering national ownership, in the
creation of an effective:
   national alliance with highest level commitment to assuring permanent elimination of
      iodine deficiency
   public information and reporting system
   national action plan, including resource (financial and personnel) development as well as a
      tactic and timeline for all efforts to become nationally-sustainable




                                                                                                 15
         IV. EXISTING NATIONAL CAPACITY FOR MONITORING PROGRESS
             TOWARD THE ELIMINATION OF IODINE DEFICIENCY THROUGH
             SALT IODISATION

1. Product (salt) Monitoring
     There is strong commitment from the National Salt Company, SALROM, to assure
      that the iodine content of food grade salt at production complies with national
      standards outlined in HG 568/June 5, 2002.
     The responsibility for assuring that food grade salt imported from outside Romania
      complies with the national standard is less clear.
     Technical capacity and capability for analysis of iodine in salt exists nationwide.
     Procedures for sample collection, data analysis, reporting and follow-up action need
      strengthening to meet modern needs of national monitoring and accountability.
     The following points need clarification and consideration for developing effective
      regulations to be associated with the current legislation:
            o   What, if any, authority requires reporting between different partners/levels
                and the frequency of reporting defined as part of this
            o   What is the stated purpose of current reporting and is action taken as a
                result of the shared information? If so, have these actions proved effective in
                preventing recurrence of any problems identified?

a) Existing information collecting systems
The five SALROM mines producing salt for human and animal consumption are responsible for
assuring that the quality of salt iodisation at production is in line with the current national
standard of 20 + 5ppm iodine. The results from quality assurance tests are shared with local
public health directorates but not, it seems, beyond that.

The food hygiene department of the judet-level public health directorates are responsible for
quality control checks of the iodine level in salt at production (where salt mines exist in the judet
– Alba, Bacau, Cluj, Harghita, Prahova, Suceava) and for monitoring the level of iodine in table
salt at retail (all judets and the municipality of Bucharest). Results of quality control checks are
shared with national partners, but generally on an annual basis.

Up to now, monitoring of household salt has not been conducted and no government body has the
authority to do this.

It is unclear who is, and will be, responsible for control and monitoring of imported and
repackaged food grade salt and, from January 2004, who will be responsible for verification that
iodised salt is being purchased and used by the human and animal food industries.




                                                                                                  16
b) National capacity, and current procedures, for monitoring iodine in salt
All iodised salt production facilities and the public health directorate in the Municipality of
Bucharest and in all 41 judets have equipment, reagents and trained personnel for titration of
iodine in salt. All laboratories use the same methodology26, however there is no exchange of
inter-laboratory quality control samples.

According to the note from SALROM (annex 4), quality assurance tests of salt iodine levels are
conducted at all mines during production flow and at the end of flow, according to SR 8934-
9/1997, which defines details of the titration method. According to the consultancy report from
Lorenzo Rossi in 2002 titration for quality assurance of salt iodine content was performed
between six and twelve times daily in the 5 mines producing food grade salt.

During this mission we visited the judet public health directorate and Targu Ocna salt mine in
Bacau. The Bacau public health directorate expressed confidence in the procedures adopted by
the producer for assuring the quality of iodised salt produced at the Targu Ocna mine, procedures
which were verified by the Chief of the salt mine quality laboratory. In general the producer takes
4-5 samples for titration during production and packaging of each lot of iodised salt. When iodine
levels are outside the range specified in the national standards, appropriate measures are taken to
adjust the level of iodine until it is within this range. Unfortunately, due to lack of time, it was not
possible to visit the salt iodisation facility in Targu Ocna mine to observe the process.

Commitment to production of a quality product was demonstrated in February 2003 when the
management of the Targu Ocna salt mine supported a meeting at their mine of laboratory
personnel responsible for assessment of iodine levels in salt, both from salt mines and from some
of the local public health directorates in those judets where salt mines are located. Aims of the
meeting were to:
   Discuss and pursue harmonisation of methodology in all laboratories, of both the titration
      procedure and calculation of iodine level, which is traditionally calculated as parts per
      million (ppm) of potassium iodate or potassium iodide, rather than as ppm iodine
   improve communication between salt mines and local public health directorates to share
      results and solve any problems which may arise in a timely manner, based on the model
      already established in Bacau
   to discuss control and monitoring of iodine content of salt at import and repackaging
      facilities (as applicable according to the law)
The meeting was considered to be the first of a series to improve understanding between the salt
producers and the monitoring entities of the Romanian Government.

The Institute of Public Health methodology (used by the local public health directorates) for
collection of salt samples for control of iodised salt quality requires that 10 samples per year need
be collected from each place of salt production for determination of iodine content. However the
local public health directorates in judets where salt mines are present usually collect more than
the minimum number of samples required. The exception to this may be the directorate
responsible for quality control of salt iodisation at Cacica mine since iodine content of only 3 salt
samples were apparently reported to the Institute of Public Health in Bucharest in 2001 (see text
in section IV-1).


26
  Titration method is taken from the manual Monitoring Universal Salt Iodization Programs, UNICEF,
ICCIDD, PAMM, WHO, MI 1995



                                                                                                     17
The 2001 report from the food hygiene department of the Institute of Public Health in Bucharest,
indicates that local public health directorates in 37 of the 41 judets plus the Municipality of
Bucharest conducted at least some tests of the iodine level in table salt from retail outlets.

c) Quality and outcome of results and reporting
Results from control checks by the public health directorates of the iodine content in salt from
production and from retail do not correlate well (see table 1 and related text in section IV-1.).
Only 3% of salt samples tested at production during 2001 had iodine levels outside the range set
by national standards whereas 52% of samples collected at retail outlets during the same year
were outside this range (with 23% above the standard, i.e. not due to loss of iodine during
storage). This indicates that both assurance of iodine content by producers, and control of these
procedures by the public health directorates, need strengthening.

At the local level, records made available by the public health directorate in Bacau showed that in
2002, 27 iodised salt samples were taken from production or storage facilities at the Targu Ocna
mine and 82 samples from retail outlets at regular intervals throughout the year. All 109 samples
contained iodine at a level between 23.5 to 29.5 ppm iodine (1995 regulations). This is an
improvement in quality from that reported in Table 1 where only 55% of 93 iodised salt samples
from retail were found to have iodine levels within the national standards. It would be interesting
to find out whether changes to the iodisation or quality assurance methods were made during the
2001 to 2002 period which may help explain the observed improvements.

The Institute of Public Health in Bucharest receives results of iodised salt tests from judet level
public health directorates, these are compiled and analysed in the Institute and sent to SALROM,
the Ministry of Health and to the judet public health directorates. The purpose of this reporting,
both to and from the Institute of Public Health, appears to be primarily for information-sharing. It
is unclear whether regulations exist requiring that judet level public health directorates report to
the Institute in Bucharest or whether any enforcement action or follow up to correct problem
areas have been applied as a result of the report findings.

d) Additional considerations
According to the 2002 report by Lorenzo Rossi, SALROM has recently undergone a number of
changes resulting in improved efficiency and increased profitability. These changes included a
large investment in packaging machines and upgrading of the processing plant at Cacica mine.
This 2002 report recommended additional changes to improve the quality of iodisation at this
mine, which had the capacity to produce 30,000 MT iodised salt per year (more than any of the
other SALROM mines). It is unclear whether the recommended change, to continuous production
of iodised salt 11 months of the year, has been made and if so, whether the effect on iodised salt
quality has been monitored.

A future short-term opportunity for monitoring the use of iodised salt by the population may be
through the health-education curriculum which will be introduced in schools in September 2003
(see section V-3c below for details)

To date the purpose of analysing of iodine in salt has been to collect information only on whether
the labelling and level of iodine in salt being sold as iodised meets national standards. There is
no methodology currently in place to provide national data on the proportion of all food grade
salt that contains iodine. Also, it would seem that the current sample collection methodology,
data management, analysis and reporting capacity are primarily designed for annual reporting
purposes and not to provide timely and relevant information for effective programme
management to ensure compliance with the new legislation.


                                                                                                 18
2. Progress in Iodine Nutrition (impact) Monitoring
        Laboratory capacity for analysis of urinary iodine exists in two national institutes.
        National baseline information on the iodine status of schoolchildren is available.
        Baseline iodine nutrition in pregnant women needs to be determined.
        Sample collection, data analysis and reporting methodologies need strengthening.

a) Urinary iodine assessment capacity
The C.I. Parchon Institute of Endocrinology and Institute of Mother and Child Care (IOMC) both
have the laboratory capacity and trained personnel to perform analysis of urinary iodine using the
ammonium persulphate digestion method. Running costs for these laboratories are being provided
by the Ministry of Health and Family and by UNICEF.

Cross-comparison of urine samples occurs between the two laboratories and there is occasional
sharing of samples for comparison with Dr Gnat’s urinary iodine laboratory at the University of
Brussels in Belgium. National resources for sending and receiving quality control samples are not
available (UNICEF has supported this activity in the past). Neither Institute has yet established a
formal connection to the IRLI lab network for inclusion in sample exchanges to augment the
confidence of results.

Both Institutes have conducted analysis of urinary iodine excretion in schoolchildren throughout
the country and the Institute of Endocrinology also has 2002 data from pregnant women (see
section IV-2)

The national study of iodine nutrition in schoolchildren, conducted by the IOMC, appears to
provide adequate national data to use as a baseline from which to monitor changes in iodine
nutrition in this population group in the future. The sampling and weighting strategy used to
select schools for this study must be clarified however. It would be important to find out the
extent to which the study was designed to give not only a national prevalence estimate but also
allow for breakdown by judet, or by urban/rural location, or other.

No qualitative or quantitative testing of salt used in the households was conducted for this study,
although the results of mother’s reporting on which type of salt was used and whether the child
had taken potassium iodide tablets was presented along with the urinary iodine results.

It was not clear which institution will be accountable to the national alliance for monitoring and
reporting on the iodine nutrition of the population of Romania and this is not precisely defined in
the 2002 legislation.

b) Information on neonatal TSH screening as a possible additional indicator
The IOMC supported and conducted neonatal screening for PKU and congenital hypothyroidism
(CH) in 32,000 newborns (3-5 day olds) in 5 judets in 2002 and this is planned to expand to
55,000 newborns in 7 judets during 2003. CH screening involves an initial analysis of TSH levels
in newborn blood spots, which can also be used as a population indicator of iodine deficiency.
The consultancy report of Prof Gerasimov27 encouraged the IOMC to perform data analysis on
27
  G. Gerasimov. Status of IDD Control and Elimination Program in Romania: A Step Away From
Universal Salt Iodization, June 2000


                                                                                                 19
existing and future TSH measurements as an additional monitoring indicator of iodine nutrition.
Dr Tomescu presented summary results of TSH from 2002. TSH analysis is preformed using the
Delphia method but no information on internal and external quality assessment procedures or
method sensitivity was obtained during the mission.

More information on these methodological parameters and on the meaning of some of the
terminology used in the summary TSH screening report are required to interpret the current
results for neonatal TSH. In iodine sufficient populations around 3% of neonates will have
elevated TSH (>5mU/L), with higher percentages characteristic of iodine deficient populations
(Sullivan et al, 1997)28. Results from the IOMC indicate 0.003 to 0.1% frequency of elevated
TSH (TSH > 5, > 20 or > 40mU/L) in neonates from different regional screening centres.

In addition, the summary table of total samples, tests and confirmed cases is not clear whether
“confirmed cases” of CH refers to neonates with TSH > 5mU/L blood (the cut off level indicating
iodine deficiency) or to those with TSH > 20 or > 40 mU/L (cut off levels used to identify cases
for further examination to diagnose CH) or whether these confirmed cases are truly CH cases,
confirmed through additional thyroid function tests.

Expenditure reports from regional screening centres placed the cost of newborn screening at
between 0.5 and 4.5 USD per newborn, quality and methodology of reporting on costs appeared
to vary between different regional centres.

3. The Quality of the Process
        Strong commitment for collaborative efforts toward the elimination of iodine
         deficiency was shown by all partners met during the mission. However Romania has a
         number of other social and public health issues requiring high political attention.
         Therefore, continuous oversight with regular advocacy and periodic renewal of
         commitments to the national goal of IDD elimination will be needed.
        Ideas for developing a national alliance and plan of action provide evidence of
         awareness of the need to monitor additional efforts in communication, education and
         resource development, and this should be further supported and sustained.
        UNICEF has been providing strong and intelligent support to national efforts, which
         should be sustained with a focus on fostering national ownership.

a) Management and responsibilities
Responsibility and mechanisms to monitor the quality of the many processes contributing to
national progress in iodine nutrition are not yet clarified. The experience of forming an officially-
recognised national alliance for sustained elimination of iodine deficiency and of collaborating to
develop a national plan of action with clearly defined responsibilities, should increase discussion
about, and understanding among partners of, the issues involved in ensuring that iodine nutrition
will be sustained.

Development of a strong management set-up with clear guidelines on roles and responsibilities,
accountability and reporting requirements appears to be needed. The 2002 legislation for staged
USI is strong in many respects, however it does not specify precisely which regulatory bodies or
institutions will have the authority to perform which task (for example monitoring salt at

28
   Sullivan KS, May W, Nordenberg D, Houston R, Maberly GF. Use of Thyroid Stimulating Hormone
testing in newborns to identify iodine deficiency. J Nutr 127: 55-58, 1997


                                                                                                  20
importing or repackaging companies) and how these institutes would be expected to coordinate
and communicate among each other and with other elements of the overall national effort.

b) Use of data for effective programme management
During the mission it was not possible to obtain full understanding about:
   where monitoring data (of the product, progress, education and communication efforts etc)
     would be collected and analysed,
   what social, resource development and political indicators of progress would be obtained
     and how, and
   who would be responsible for relating and using the information for management decisions,
     coordination of national efforts and public reporting, and how.

At present, UNICEF appears to be fulfilling the role of data collection and information centre for
all aspects of national efforts, as a result of information requests made by the country office to
counterparts and sharing of these with other partners. Obviously this needs to become a national
responsibility.

c) Communication efforts
With regard to public communication efforts, a national campaign to increase awareness of iodine
deficiency and to create consumer demand for iodised salt is to be launched shortly. The
strategies underlying this campaign are based on detailed research conducted by Population
Services International (PSI) Romania, under contract to UNICEF Bucharest29.

The campaign will be focused on six-sixteen year olds and is expected to last for approximately
two years. The impact of the campaign will be assessed via media recall in January 2004 and
through a survey of Knowledge, Attitudes and Practice (KAP) and household salt use at the end
of 2004, depending on funding.

Sustainability of the impact is planned through periodic media reminders and eventual integration
of messages into the education curriculum, although the Centre for National Health Promotion at
the Ministry of Education, was not yet aware of the PSI research and proposals.

During the mission we learnt, from personnel at the National Centre for Health Promotion,
Ministry of Education, about the curriculum for health education in schools. This curriculum had
been developed in partnership with the Ministry of Health and will become a recommended (but
not mandatory) part of the regular school curriculum for 1st to 12th graders in September 2003.
Education on IDD and the use of iodised salt are included in different aspects of the curriculum
for 1st, 2nd, 7th and 9th grades.

There was strong interest to include qualitative (test kit) testing of salt to the module for 1st and
2nd grades as part of this awareness-raising process. Infrastructure already exists for reporting of
different types of social information collected from individual schools back to the central level.
This mechanism could be used to also provide information on the proportion of households using
iodised salt. Careful thought should be given as to the minimum amount of information needed to
monitor national household use adequately and where this data would go for analysis, in order
that the technical information would be useful for management decisions and the educational
information system would not be overloaded.

29
     Iodine Deficiency Disorder Research Results and Communication Strategy, PSI August 2002.



                                                                                                  21
It is recommended that the opportunity to test household salt at schools be used to compliment
other product monitoring efforts for 2-3 years. After this time it may become unsustainable or no
longer be required and more value should be placed on its strength as an educational, awareness-
raising, element among school children.

An additional opportunity for consumer education which is yet to be fully explored in Romania is
through salt sales channels. The director of the salt mine in Targu Ocna explained that they had
already assumed the role of educating purchasers of food grade salt about the national legislation
for staged USI and the reasons for it and were advocating for the food industry to start ordering
iodised salt before the end of 2003. The salt mine had also modified their contracts with buyers to
include information on the Government Decision and the associated new national norms.

The director of the mine felt informed enough to be fairly comfortable in this role, but requested
additional information to be able to inform buyers more fully on the impact of iodine on both
human and animal health. These efforts deserve to be expanded to all salt producers and the
import/repackaging firms, and implemented and monitored in coordination with the public
communications campaign mentioned above.




                                                                                                22
           V. RECOMMENDATIONS

For a monitoring framework to assess permanent progress in national elimination of iodine
deficiency through mandatory Universal Salt Iodisation in Romania.

This section includes overall recommendations on the minimum information required to
effectively monitor both the quality and sufficiency of iodised salt and national progress in iodine
nutrition in Romania, and suggested systems to acquire this information. The general description
is followed with additional details on how these systems may be implemented.

Specific recommendations identifying where existing capacity would need strengthening and
where there are apparent gaps in availability of financial and/or trained personnel resources are
included. Recommendations for monitoring “processes” contributing to the national progress are
not included as a sub-section of their own, since this was not the main aim of the mission.
However, comments relating to some of these supporting processes are included below in the
sub-sections below, as they relate to the areas of product and progress monitoring, data
management and reporting.

1. Product (Salt) Monitoring

a) Focus product (food grade salt) monitoring on ensuring continuous adequate amounts of
   domestic production and import of high quality salt with the appropriate level of iodine, for
   table salt initially and, from Jan 2004, for all salt for human and animal consumption

Rationale
  Responsibility for assuring the quality of iodised salt produced and imported in Romania
      lies with the salt producers (domestic and international). Salt produced for the Romanian
      market comes from producers with proven capacity (trained personnel and analytical
      resources) in quality assurance procedures, and with recognised accountability to comply
      with national legislation.
  Quality control checks can be performed by the local public health directorates where
      personnel and technical resources for analysis of iodine in salt already exist.

Recommendations
   i. Producers need to maintain regular checks on salt samples from the iodisation and
      packaging lines, according to nationally-agreed guidelines. It is suggested that checks are
      done once per hour or an agreed number of times per lot and that these are recorded and
      shared.
  ii. The local public health directorate should visit the salt mine once a month to check quality
      assurance log books, collect salt samples for control checks, record information on
      purchase orders for iodised salt, and to discuss any recent issues of concern which may
      have arisen, thereby maintaining greater collaboration between the two bodies.
 iii.    SALROM should take the lead in working with personnel from its salt mines and from the
        institute of public health, to develop appropriate quality assurance guidelines for all salt
        mines producing food grade salt. These guidelines should detail the procedures (collection,
        testing and reporting methodologies) for quality testing and for associated decision-making
        and follow-up, along with an estimate of the resources needed to provide training in these
        areas if necessary. If such national guidelines already exist, they should be reviewed and
        their use at each mine verified.



                                                                                                 23
     iv. Reporting procedures need strengthening based on whom the information will be reported
         to, how often, and for what purpose. If corrective action is required, the outcome of this
         action in preventing recurrence should also be included in the reporting system.
     v. Reporting criteria should be changed to provide all information on iodine content of salt in
        units of parts per million (ppm) iodine instead of ppm potassium iodate or ppm potassium
        iodide. Using ppm iodine makes results more meaningful (the interest of public health
        nutrition is in the amount of iodine being consumed only), gives comparable titration
        results from salt iodised with iodate or iodide and allows direct comparability with results
        from other countries which report in the internationally-recommended units of ppm iodine
        (see codex standard 150-1985, Amend 2-2001).
     vi. An iodised salt sample exchange system for assurance of the quality of titration analysis in
         all laboratories (salt mines, public health directorates and academic institutions) should be
         established. One of the salt mines could produce batches of salt with different known iodine
         content, which would then be distributed between laboratories for assurance and regular
         reporting of accuracy and reproducibility parameters. Analysis of data should be conducted
         by an independent body (?) or by the Institute of Public Health in Bucharest, for subsequent
         feedback of lab-specific results and recommendations for in-house improvements or
         retraining as needed.
 vii. A related international resource which may be a source of advice and technical expertise if
      needed, is the International Resource Laboratories for Iodine (IRLI) network30.
viii. An annual analysis of the domestic salt situation (by SALROM or other?) may be useful to
      confirm where the largest producers and importers of food grade salt are, whether their
      capacity for production and iodisation or for import of food grade salt has changed in any
      way and who their major customers of iodised salt are.
     ix. With regard to assuring sufficiency of iodised salt for the population, SALROM quoted an
         estimated national requirement of 80,000 metric tonnes based on consumption of 3.5 kg salt
         per person per year. This appears low in comparison to calculation of total food grade salt
         production needs from other countries where a figure closer to 5 kg salt per person is used.
         A salt situation analysis may provide additional information on the actual amount of food
         grade salt, from production and import, that is used by the population nationally.

     x. Immediate attention should be given also to the quality of iodised salt from the Cacica
        mine. Lorenzo Rossi’s salt situation report recommends making changes to the production
        technique to improve the quality of iodisation but it is unclear if these recommendations
        been applied and if so, whether the quality of iodised salt has improved.

     xi. The salt mine at Praid is the main source of salt for animal husbandry15. This mine
         produces pressed salt blocks containing mineral mix, most of which are for export (mainly
         to Hungary). In preparation for the legislated requirement that all salt for animal
         consumption should be iodised from January 2004, it is recommended that the mine at
         Praid is also included in the proposed assessment procedures, starting as soon as possible.



30
   For more information on the International Resource Laboratories for Iodine (IRLI) Network, see
http://www.cdc.gov/nccdphp/dnpa/immpact/global/irli_network.htm or e-mail iodinelab@cdc.gov.




                                                                                                   24
b) Additional recommendations for effective monitoring of the quality and sufficiency of
   iodised salt in Romania include:

i. Develop a flexible monitoring framework
   If product quality is assured and results reported regularly along with information on
   purchase orders for iodised salt at production, this should allow for effective management
   decisions and reduce the number of problems along the rest of the food grade salt sales chain.
   However it will still be important to build national confidence that iodine levels in salt at
   different points in the retail chain (including imports) are in agreement with national norms
   and that sufficient iodised salt is available for, and being used in, the table and cooking salt
   market (from January 2003) and in human and animal food industries (from January 2004).

   Revision of methodology to be used for monitoring food grade salt in Romania should allow
   for flexibility according to experiences and confidence in assuring the quality of iodised salt
   at production and import and the consequences of this on the iodine nutrition of the whole
   population.

   National partners with a potential role in monitoring the quality and sufficiency of iodised
   food grade salt in Romania include the Public Health Inspectorate, the Public Health Food
   Hygiene Department, SALROM, the Ministry of Agriculture, the Ministry of Education and
   national authorities (which still need to be identified and nationally accepted) responsible for
   monitoring imports of food grade salt and for food grade salt at repackaging locations.

   These partners should work together to define the methodology to adequately assess and
   report on the quality and sufficiency of iodised salt nationally. Key questions to ask in
   defining a framework for monitoring are as follows:
      How will the information be used and who is the user?
      Where will the information be collected?
      Who should collect it?
      What should be reported and to whom?
      How often does the information need to be collected and reported?
      What resources (financial/personnel/training) will be required, and are available
         nationally, to manage this?

   Given the limited resources available in Romania, it is recommended to focus initially on
   obtaining only the minimum amount of information required for effective reporting and
   management of national efforts, which include defining and strengthening data collection,
   analysis, decision and reporting mechanisms (as in point ii below).

   Consideration should be given to the value and use of information which may be collected
   from the following points of the food grade salt market. Collaborative decisions can then be
   made on which points will be essential to meet minimum requirements for national oversight
   and accountability:
        Production – see point a) above.
        Importing and repackaging companies – to assess the scale and quality of the import
         market and of salt which is repackaged domestically.
        Retail outlets - to assess whether any non-iodised salt is being sold for human
         consumption (leakage into the market).


                                                                                                25
         It is recommended to continue regular monitoring of salt at retail31 but to change and
         strengthen current procedures for reporting. Reporting from tests at retail outlets should
         focus on the proportion of non-iodised salt samples available for household use
         (number of samples with 0ppm), salt source and labelling, rather than on the level of
         iodine in salt products labelled as iodised (number of samples with >15ppm).
         Finding salt with no iodine implies non-compliance with the legislation, which may
         require detailed investigation, feedback and imposition of warnings or fines, whereas
         finding salt with levels of iodine below that expected at retail implies either that the
         national standards for iodine in salt at retail are too high (currently 20+5ppm, the same
         as levels at production which does not allow for any decrease in iodine during storage
         and transport) and/or that quality assurance at production needs to be improved, a fact
         that can be detected more easily and rapidly by production monitoring.
        Household - to assess availability and acceptability of using iodised salt in the home.
         Qualitative (test kit) and possibly some quantitative (titration) testing of household salt
         could be conducted in conjunction with recommended modules about iodine deficiency
         in the new health education curriculum at school. Testing and feedback from a
         predetermined number of schools, selected to be reflective of the national situation may
         be used to alert management to any leakage of non-iodised salt to the household.
         Information collected could include information on brand type also.
         Methodology for minimum necessary data collection and for management of data
         reporting and analysis would need to be carefully defined in conjunction with other
         monitoring activities.
         This school-based monitoring system would not be considered as a long term (over 5
         years) part of the product monitoring system. It would be difficult to sustain the salt
         testing, due to the novelty waning, and the logistics and resources involved in
         providing test kits and obtaining results from schools. It makes more sense to
         concentrate longer term resources on monitoring at production and retail (if required),
         where the national regulations provide authority for follow-up and action if necessary.
         School-based information and testing should be encouraged to continue however, since
         it will be important in terms of sustained future consumer education.
        Food industry - to assess the availability and acceptability of using iodised salt in
         industrial manufacturing of foods for human and animal consumption.
         Effective monitoring of urinary iodine excretion of the population (see section 2 below)
         should provide good evidence of changes in iodine nutrition as a result of iodised salt
         use in Romania’s major food industries. However for the period 2004-2005 at least, it
         is also recommended to actively monitor the use of iodised salt at some of the country’s
         largest food producers, including information on its use by bread bakeries, through
         collection and analysis of salt samples from these food producers.
         The Ministry of Agriculture is responsible for licensing and certification of food
         producers in Romania. Consideration should be given to making such certification
         contingent on the requirement of iodised salt use. SALROM mines would also be able
         to provide records on iodised sales of salt to the food industry.


31
   The recommended frequency and number of samples to be collected from retail outlets depend on
the confidence in the quality of the product at entry to the market



                                                                                                   26
            As with the other points above, the value of any information collected depends on
            careful selection of the food industry, the methodology for data collection and the
            meaningful use of data for programme management decisions.


ii. Develop capacity of all partners in data collection, management and reporting techniques.
     Currently most reporting appears to be done on an annual basis, or as the result of an
     information request by UNICEF. A strong national monitoring system will require more
     frequent and higher quality reporting of information required to assure and maintain national
     progress and to make appropriate management decisions where progress is seen to be
     failing.

       Reporting requirements – the purpose of data collection, who will use the information, how
       often is it required etc – should provide the basis for development of the monitoring
       frameworks suggested above (see section V-3a below).

iii. Address possible constraints to achieving USI raised by SALROM
      Attention should be paid to whether the present concerns about repackaging companies
      selling non-iodised salt with iodised salt packaging from SALROM and/or imports of
      unpackaged non-iodised salt from Ukraine or Belarus are a significant barrier to achieving
      USI in Romania.
      SALROM has a commercial interest in verifying whether such activities are ongoing and if
      so where, the source of any non-iodised salt and the market share of the product. SALROM
      may have conducted at least some such market analysis of this already and could present
      these results to the national alliance for further verification and follow up by the relevant
      authorising bodies.
      Given some of the concerns raised during the meeting with SALROM we would suggest that
      the management of SALROM contacts M. Bernard Moinier, Secretary of the European Salt
      Producers Association (ESPA)32 to request assistance in adapting to the changes imposed on
      the Romanian salt industry as a result of national legislation for USI. In particular, the aim
      would be to learn from other countries in Europe about their experiences with the use of
      iodised salt in the food and animal food industries and in product promotion, related to the
      added benefits of using iodised salt.

iv. Assuring the quality of communication efforts
    Maintained awareness of consumers and of buyers of salt for the animal and human food
    industries about iodine deficiency and the importance of using iodised salt is key to sustain
    the above (industry and government) quality-assurance systems.

      A communication strategy aimed at raising awareness of consumers is being implemented by
      PSI with the support of UNICEF. It is recommended that the national alliance (of which PSI
      will be a supporting member) consider ways to sustain this awareness beyond the campaign-
      style activities. (Raising consumer awareness is not so critical once USI is mandated and
      enforced, i.e. once there is only iodised salt on the market. If Romania achieves this goal of
      true USI then it may more valuable to concentrate resources on developing societal
      acceptance through more sustainable and lower cost strategies, such as inclusion of

32
     ESPA Tél: 33 1 47 66 52 90 Fax: 33 1 47 66 52 66 e-mail: bmoinier@eu-salt.com



                                                                                                 27
         information in a variety of educational systems and in encouraging salt producers to develop
         product marketing efforts). Suggested channels are:
              Through the school-based health education system which will be introduced in
               September 2004 - in expectation of child to adult education.
              Through insertion of relevant information on iodine deficiency and USI into
               professional education and information-sharing systems for health-care providers and
               for the veterinary and food industries.
              Through salt producers, some of whom who are already playing a role in educating
               bulk buyers of salt about the legislation for USI and reasons for it. (The assumption is
               that buyers of salt at production will pass on this knowledge down the retail chain to,
               ultimately, the consumer. It would be worthwhile therefore for national efforts to
               include a product marketing element)

         During the mission, requests for information and assistance in developing and delivering the
         most appropriate messages on iodine deficiency and its elimination through salt iodisation
         were heard from the Ministry of Education (Health Promotion33), the Ministry of Agriculture
         (Food industry and Sanitary Veterinary Departments34) and from the director of Targu Ocna
         salt mine. It is recommended that bringing appropriate partners together and responding to
         these requests could be among the first tasks of the national alliance once formed.


2. Impact/Progress Monitoring

a) Focus impact monitoring on assessing trends in iodine nutrition among pregnant women
   during the early part of pregnancy.

Rationale
          The major effect of iodine deficiency is on the developing brain of the foetus and occurs
           during the first half of pregnancy35
          The aim of universal salt iodisation is to provide effective and safe levels of iodine reaching
           the entire population through a variety of sources of salt in the diet
          Iodine nutrition of other groups in the population may not always be representative of
           iodine nutrition of pregnant women
          Monitoring trends in iodine nutrition in pregnant women during the early part of pregnancy
           provides reliable information on national progress toward the protection of developing
           foetal brains from iodine deficiency. Such data will provide confidence from proven
           national success and a sound basis for future adjustment to salt iodine levels as and when
           needed




33
   The UNICEF Regional Office for CEE/CIS and The Baltics in Geneva may be able to share examples of
educational materials on iodine deficiency that have been developed and used in other countries in the
region.
34
   Information on the effect of iodine deficiency in animals can be found at
http://www.saltinstitute.org/47q.html
35
   See footnotes 4 and 6. Xue-Yi et al. and Stanbury


                                                                                                       28
Recommendations
i. To continue monitoring of iodine nutrition in schoolchildren for the next few years.
       The recommendation to focus on iodine nutrition during pregnancy does not preclude
       continuous monitoring of the iodine status of schoolchildren, in fact it is suggested that this
       group should continue to be monitored also for at least the next few years.
       Assessment of changes in iodine nutrition in the two population groups over the next 2 to 3
       years would allow for evaluation of any differential effect of the staged legislation in these
       groups and provide an opportunity to develop national confidence in monitoring iodine
       nutrition during pregnancy and in interpretation of results among pregnant women (in
       reference to changes among school children). These reasons are explained in more detail as
       follows:
            Iodisation of all food grade salt is expected to produce a significantly improved impact
             on the iodine nutrition status of the population, when compared with iodisation of table
             salt only. Women in Romania are recommended to reduce table salt intake during
             pregnancy36. Therefore, additional iodine consumption through the use of iodised salt
             in the food industry for human and animal consumption may be of greatest benefit to
             pregnant women, thus critical to protecting foetal brain development during the first
             half of pregnancy.
            It will be important to obtain data to record the relative impact of the two stages of the
             national legislation on iodine nutrition of pregnant women. Such data could be used to
             re-advocate for USI in the face of any future waning in elimination efforts. An
             important element for sustainability is that each nation establishes its own historical
             experience and record of how the elimination of iodine deficiency was achieved and
             why it was achieved in that way.
            Established cut offs for adequacy of urinary iodine during pregnancy are being
             developed internationally. In the meantime, a baseline study including urinary iodine
             excretion, along with other indicators from which to determine sufficiency of iodine
             nutrition in this group, would provide national acceptance of appropriate cut offs to use
             in national monitoring and important information also for other countries.
            Such a monitoring system would not need to be nationally representative but should be
             reflective of the national situation, by sampling women according to income level or
             from different regions according to the major brand and iodine content of table salt
             used in that region (there currently appears to be lower use of iodised table salt in NE
             and SE37).

ii. To obtain timely national reference data a) to capture the effect of staged USI and b) to
    provide a baseline for longer term monitoring of iodine nutrition in the population.
       It is recommended that a comparative study of household iodised salt use and its relation to
       iodine nutrition in pregnant women and in schoolchildren be conducted within the next year.
         Ideas to explore for such a study include:
            Identification of women during the first half of pregnancy, most conveniently when
             they visit an antenatal clinic for the first time, and obtain information on iodine


36
     Iodine Deficiency Disorder Research Results and Communication Strategy, PSI 2002
37
     PSI report, as above


                                                                                                    29
         nutrition (urinary iodine) and use of iodised salt at their homes. It may also be possible
         to assess the change in iodine nutrition status during pregnancy in these women by
           o   measurement of thyroid volume at first contact with a follow-up measurement at
               the time of delivery,
           o   assessment of TSH in the newborn.
        Parallel identification of, and assessment of iodine nutrition in, school age children (8-
         12 years) from the same community (probably through schools) and with similar
         patterns of household iodised salt use/non-use as the pregnant women. It most likely
         would not be feasible to study pregnant women and school age children from the same
         household since the crude birth rate in Romania is only 10/1,000 population
         (Population Reference Bureau, 2002 estimate).
        Comparison of data on likely iodine consumption through the use of iodised salt in the
         household, and on measured iodine nutrition status between the two groups, will
         provide a basis from which to assess and compare the relative impact of increased
         dietary iodine resulting from staged USI on iodine nutrition status in these two different
         groups of the population.
   Potential constraints to the suggested study and national implementation of longer term
   monitoring of iodine nutrition in pregnant women would appear to be access to women
   during the first half of pregnancy, lack of personnel and other resources, such as funds for the
   transport and analysis of the urine samples and identification of a group willing to conduct
   the study. These issues would need discussion as part of the planned national working group
   on monitoring progress in iodine nutrition.
   There were conflicting personal reports on the gestational stage when a woman typically
   attends antenatal care for the first time and this needs clarifying. Aside from increasing the
   chances of a healthy pregnancy through increased access to antenatal care, there are
   additional reasons for the Government to encourage early attendance of pregnant women at
   antenatal clinics, such as for counselling to Prevent Mother-to-Child Transmission (PMTCT)
   of HIV.
   The National Health Insurance Fund is a specialised public institution that sets rules for
   functioning of the social health insurance system, through negotiation of a framework
   contract with the College of Physicians. The College of Physicians therefore has influence on
   the type of reimbursement mechanism for health service providers, as well as having
   responsibility for certain areas of training and accreditation of physicians. It would seem
   feasible to suggest working with both the National Health Insurance Fund and the College of
   Physicians to negotiate reimbursement criteria for providers for public-health related data
   collections and also to discuss insertion of educational material on iodine deficiency into the
   training curriculum for physicians.
The principle of making iodine nutrition during early pregnancy the focus of a national impact
monitoring system met with agreement during discussions with partners from the Ministry of
Health and Family, the Institute of Maternal and Child Care and from UNICEF. It was not
possible however to develop detailed plans and methodology for such a system in the short time
available of this initial visit.




                                                                                                30
b) Additional recommendations related to monitoring progress in iodine nutrition in Romania.
These include:
 i. The need for participation by the urinary iodine laboratories in the country in an international
    sample exchange program among iodine laboratories (IRLI). The International Resource
    Laboratories for Iodine (IRLI) network is an international resource, which will provide a
    source of exchange of materials, advice and technical expertise. Of the resource laboratories
    in Europe, one is Dr Ivanova’s laboratory in Bulgaria and the other is Dr. Gnat’s laboratory in
    Belgium (where the Institute of Endocrinology has previously sent samples for cross-
    checking of results).
         If these laboratories are not currently fully functioning as resource laboratories with prepared
         QC material, it would be possible for the laboratories in Romania to apply to be part of the
         CDC’s EQUIP programme, which shares QC material and provides feedback and
         recommendations on laboratory performance.
ii. Urinary iodine results should not be used for assessing iodine nutrition of individuals, as
    implied in the 2002 report on annual costs for diagnosis and treatment of iodine deficiency38.
iii. Developing capacity of all partners in data collection, management and reporting techniques.
iv. Following up with IOMC on the questions raised in section XX, on TSH screening and
    interpretation of results. TSH is not as cost-effective an indicator of iodine nutrition as
    urinary iodine, nor as easily obtained. However if a sensitive assay is being used to collect
    data on neonatal TSH for CH screening, we would recommend to use this data to add to the
    national monitoring system.

c) Include collection of information to capture the effect of improved iodine nutrition on other
   health outcomes, which will have a direct economic benefit to the health care sector
Rationale
          Improved iodine nutrition throughout the population will, over the medium term (5-10
           years), lead to reduced health care and insurance company costs presently incurred by
           diagnosis and treatment of thyroid-related diseases in the elderly.
          Tracking cases of Plummer’s Disease and Graves Disease over the long term would be
           expected to
                 o   Alleviate concerns about sustained increases in the incidence of iodine-induced
                     hyperthyroidism
                 o   Provide data on the health AND economic benefits of adequate iodine nutrition
                     for the whole population, which may be important for advocacy to prevent
                     potential waning of the elimination effort in the future
          The Institute of Endocrinology and the national network of endocrinologists already tracks
           the number of cases of different thyroid pathologies nationally, thus capacity to obtain the
           information exists. Additional recommendations would be to standardise reporting of these
           cases, to include costs of diagnosis and surgery and to support a consultation with an expert
           in health economics or a similar field on how to use this data most effectively.

38
  Report on activities and costs of the sub-programme “Endemic Goitre – Prophylaxis and Prevention of
Complications” from the C.I. Parchon Institute of Endocrinology to Ministry of Health and Family, General
Dept of Health Care and Programmes, 2002



                                                                                                      31
3. Additional Recommendations Related to Assuring Sustained Elimination of
   Iodine Deficiency through USI in Romania.

a) Establish and support an impartial data collection, analysis and reporting centre, with
   accepted timelines for reporting on specific indicators of progress to different stakeholders,
   including national leaders

         Judet and national level capacity for monitoring and salt sample analysis is relatively
          strong which greatly facilitates data collection, however data management in terms of
          timing and content for reporting to central level and for information sharing among
          partners appears to be inadequately defined at present.
         There are a number of different partners who could be involved in collecting data for
          monitoring (especially information on product monitoring). It will be important to have
          effective coordination and synergy of roles, responsibilities and information-sharing
          activities to avoid duplication of efforts while using elements of the existing
          infrastructure to maintain an effective, minimalist, monitoring and reporting system.
         Regular reporting on key progress indicators will be important for continued advocacy,
          awareness and motivation among all partners, initially to reassure that the goal of IDD
          elimination is being achieved, and that national elimination is being sustained.
          Different levels of reporting, types of information and frequency will be effective for
          informing and advocacy among different partners.
         Establishing an independent centre for data collection, analysis and reporting can
          provide a means for
            o   High professionalism about what to report, when, to whom and for what purpose
            o   Impartial interpretation of data and public reporting
            o   Providing public assurance of the permanency of elimination
         If such a centre was also responsible for providing information on other national goals
          it may assure better secured funding and political support.
         This centre could have an expanded function as a secretariat for the national committee,
          or be linked to another body with this function. An impartial secretariat would help to
          co-ordinate information flow from and between partners, regarding data collection and
          dissemination and information exchange on new initiatives, changes to normal
          practices etc by any of the partners involved.
         This role could best be taken by an academic organisation or an NGO.

b) Consider initiating/continuing an annual event (or inclusion in an existing appropriate event)
   to maintain political commitment at the highest level, to report the effectiveness of existing
   policies and provide a forum for discussion of changes to the policy if necessary.


c) Re-orientation of International support




                                                                                               32
     The will to maintain a favourable policy environment for the elimination of iodine deficiency
     and to establish strong monitoring systems for assuring permanence of elimination appears to
     exist among many partners. It is recommended that UNICEF, along with other international
     organisations, should focus on providing a strong supporting role, while fostering national
     ownership, in the creation of an effective:
      National alliance with the highest level of political commitment to permanent elimination
         of iodine deficiency
      Public information and reporting system
      A national action plan, including resource (financial and personnel) development as well as
         strategies and a timeline for all efforts to become nationally-sustainable
d) Utilise assistance and support available from the Iodine Nutrition Network.
       The Iodine Nutrition Network39 would be able to assist and support national efforts as
       requested. In particular, assistance could be provided with:
             Assessment of national progress in due time.
             Assisting Romania to position itself as an example of success in the region .
             Sharing experiences from, and inviting Romania to be a part of, the International
              community working toward sustained global progress in iodine nutrition.
       CDC and ESPA are both members of the Iodine Nutrition Network.

4. Next Steps

It is recommended that upon acceptance of the analysis in this report:
 Romania should
      Co-ordinate a Working Group for Monitoring, under the structure of the national alliance,
          to develop a framework for monitoring and reporting on the quality and availability of
          iodised salt and national progress toward sustained elimination of iodine deficiency.
      Develop detailed short and long-term action plans to implement the steps of the
          framework, including identification of training needs and financial and personnel
          resources that will be required.
      Begin implementing these action plans as soon as possible.
 UNICEF Bucharest should
      Provide a strong supporting role for the activities above, while reorienting assistance
          toward national ownership and assured permanence of national progress toward
          elimination of iodine deficiency.
 CDC/IMMPaCt will
      Be willing to provide additional technical expertise to support the national development
          and implementation of an effective monitoring system.




39
     http://www.IodinePartnership.org


                                                                                               33
ANNEX 1

Monday, April 7                    Tuesday, April 8            Wednesday, April 9               Thursday, April 10                    Friday, April 11
Meeting @ UNICEF                   Ministry of Health and      Ministry of Agriculture          Bacau                                 Population Service
Hamid El-Bashir, Pgm. Officer,     Family (MoHF)               eng. Elena Manciulea, Dept       Meetings at Public Health             International (PSI)
Voica Pop, Health consultant       dr. Alexandru Rafila,       Food Industry                    Directorate                           Daun Fest, director,
                                   general director of the     dr. Eugenia Sendra, National     dr. Angela Aflori - Director,         Codruta Hedesiu,
                                   Directorate for Public      Agency for Sanitary Veterinary   Laboratory for Surveillance,          communication officer
                                   Health                      (surveillance)                   Control and Inspection                UNICEF
Salrom (Salt producer)             Institute for Mother and                                     dr. Daniela Pascu - chief inspector   Debriefing @ UNICEF
Petrisor Chelaru, technical        Child Care (IOMC) /                                          dr. Puiu - chief inspector, Food      Pierre Poupard, Rep.,
manager,                           dr. Alin Stanescu, deputy                                    Hygiene Department                    Voica Pop, Health consultant
Maria Florea,                      director,                                                     Daniela Ciobanu - chemist,
quality inspector                  dr. Rodica Nanu,                                             Laboratory for Food Hygiene
                                   dr. Emil Tomescu,                                            Dr Bustuc, deputy director, public
                                   dr. Lili Pasat                                               health directorate

Lunch                              Lunch                       Lunch                            Lunch                            Lunch
Ministry of Health and             Institute for Public        Ministry of Education (ME)        Salrom salt plants (Targu Ocna) Report writing
Family MoHF                        Health                      Daniela Calugaru, inspector,     eng. Marius Tanasie, director;
dr. Stefan Bartha, director of     dr. Camelia Parvan,         National Center for Health       eng. Ilie Ionel, chief engineer;
the Directorate for Medical        dr. Viorica Gheorghiu,      Promotion                        Ms. Cernea, chief of quality
Assistance;                        dr. Camelia Stanescu,       Dumitru I. Dumitru, Deputy       laboratory
dr. Gabriela Dumitran,             dr. Carmen Dumitrache,      Director
Counsellor, General Dept           dr. Lili Pasat
Medical Care Programs;
dr. Cristina Chiotan, Manager,
General Dept Medical
Assistance and Programs
dr. Lili Pasat, Chief Inspector,                                                                Return to Bucharest
Sanitary Insepction
dr. Mihaela Simescu,
Endocrinology Institute
Meeting @ UNICEF /                                             Departure for Bacau
Debriefing with dr. Lili Pasat
and dr. Voica Pop




                                                                                                                                                              34
ANNEX 2



     Salt Extraction Industry - Romania

                                                      Salinas
                                Cacica
                                                      Salt
                                                      mines
                                                      SALROM
                                                      ’s
                                                      production
                  Ocna Dej Praid                      unit


                                         Targu Ocna
                   Ocna Mures


                                Slanic Prahova
               Ramnicu Valcea



                                   SALROM




                                                                   35
        ANNEX 3

                         GOVERNMENT OF ROMANIA
                              DECISION
 Regarding universal iodization of salt intended for human and animal
            consumption and for use in the food industry


Based on the provisions of article 107 of the Romanian Constitution,
The Government of Romania passes this Decision


                                             CHAPTER I
                                      General dispositions

Art. 1.   This Decision regulates the requirements for universal iodization of salt intended for human
consumption, animal feed, and use in the food industry, in view of preventing iodine deficiency disorders.

Art. 2.   For the purpose of this Decision the following terms and phrases are defined as follows:

        a)   Iodine deficiency disorders are pathological conditions, manifest or hidden, that appear as a
             result of thyroid gland dysfunctions caused by an insufficient intake of iodine into the body;

        b) Prevention of iodine deficiency disorders is the range of measures taken in order to satisfy
           the body’s need for iodine, consumption of universal iodized salt being the most accessible
           means to achieve this goal;

        c)   Universal iodization of salt means the process of adding iodine to salt, for every type of use:
             human, animal, food industry;

        d) Edible salt for human consumption is a crystalline product composed predominantly of
           sodium chloride (NaCl), obtained by extraction from natural underground sediment or from
           sea water, as per Codex Standard for edible salt;

        e)   Iodized salt is salt intended for human consumption, animal feed and use in the food industry,
             to which iodine has been added, in the form of potassium iodate or iodide.




                                                                                                         36
                                              CHAPTER II
                              Quality and safety requirements

Art. 3.     In Romania, only iodized salt is used for human consumption, animal feed and in the food
industry.

Art. 4. (1)     Quality and safety requirements for the salt used as base for obtaining iodized salt must be
consistent with S.R. 13360/1996. The content of NaCl in the salt to be iodized shall not be lower than
97%.

           (2) Iodized salt shall contain 20 + 5 mg iodine / kg of salt, respectively 34+8.5 mg potassium
iodate / kg of salt, or 26+6.5 potassium iodide / kg of salt.

Art. 5.       The method used for salt iodization, the quality and safety, the iodine concentration, the
monitoring measures applied in the iodization process and the storage until consumption / use of the iodine
level established by this decision shall meet all the requirements imposed by regulations in force.

Art. 6.     (1) Production processes - purification, re-crystallization, iodization -, packaging and labeling,
as well as transportation, storage and marketing of salt shall be carried out in strict observance of hygiene
norms in force regarding food safety, avoiding any risk of contamination.
             (2) The norms regarding food safety shall also be enforced in the case of imported iodized salt.

Art. 7.   The packaging used for iodized salt shall retain salt quality and established iodine level until the
minimal date of durability established by the producer.

Art. 8.     The authorities / institutions with monitoring competence in the field of food safety have the
obligation to identify / determine the presence of iodine / the iodine level in iodized salt.

Art. 9.   Labeling iodized salt shall be consistent with legal provisions in force. The product shall be
marketed under the name “Iodized salt”.

Art. 10.    On the territory of Romania it is forbidden: to import in view of marketing, as well as to
produce and market non-iodized salt for human and animal use and for use in the food industry.




                                                                                                           37
                                             CHAPTER III
                                  Inspection and monitoring

Art. 11.      Inspection and monitoring of iodized salt are obligatory and are carried out by designated
representatives of the Ministry of Health and Family, the Ministry of Agriculture, Food and Forests, the
National Authority for Consumer Protection, as per their competence.


                                             CHAPTER IV
                                              Sanctions

Art. 12.    The following constitute contraventions and are sanctioned as follows:

   a)    delivery by producers or importers of iodized salt for human and animal consumption and for the
         food industry, with an iodine level below the one established by this decision, with a fine ranging
         from 100 to 150 million lei;

   b)    use of non-iodized salt in the food industry, with a fine of 100 to 150 million lei;

   c)    marketing of iodized salt with an iodine level below the one established by this decision, as a
         result of the non-compliance by the economic agent of the transportation, storage and marketing
         requirements established by the producer, with a fine of 50 to 100 million lei.

Art. 13.      Committing the acts mentioned in Art. 12 is sanctioned, besides the fine, with suspension of
the activity of the economic agent, as per specific regulations by the authorities mentioned in Art. 11.

Art. 14.     The staff designated by the competent authorities mentioned at Art. 12 will ascertain the
contraventions and impose the sanctions.

Art. 15.       The provisions of Government Ordinance no. 2/2001 regarding legal conditions of
contraventions, approved with modifications by Law 180/2002, are applicable to the contraventions
mentioned in Art. 12.




                                                                                                         38
                                             CHAPTER V
                                        Final dispositions

Art. 16.      The Ministry of Industry and Resources, the Ministry of Health and Family, the National
Authority for Consumer Protection, the Ministry of Agriculture, Food, and Forests, the Ministry of
Education and Research, have the obligation to develop the action plans to create conditions for the
enforcement of this Decision.

Art. 17.     The provisions of the present Decision shall be applied to salt for human consumption starting
with 31.12.2002, and to salt used in the food industry and for animal feed starting with 31.12.2003, except
for the provisions of Art. 16 which shall be applied starting with the date of publication in the Monitorul
Oficial of Romania.

Art. 18.       On 31.12.2002 will be abrogated the Government Decision no. 779 / 1995 regarding the
regulation of iodized salt consumption, published in the Monitorul Oficial of Romania, Part I, no. 233 of 10
October 1995 and point 16, letter c) of the annex no. 1.a) to Government Decision mo. 106 / 2002
regarding labeling of food products, published in the Monitorul Oficial of Romania, Part I, no. 147 of 27
February 2002, as well as any other provisions contrary to the present decision.




PRIME MINISTER

ADRIAN NASTASE




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