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

FINAL DRAFT

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.

1

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.

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.

Table of Contents

EXECUTIVE SUMMARY

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

I.INTRODUCTION

II.BACKGROUND

1.Recognition of Iodine Deficiency Disorders

2.History of Interventions to Eliminate Iodine Deficiency

3.Current Legislation for Universal Salt Iodisation

III.GENERAL FINDINGS FROM THE MISSION

1.Iodised Salt Situation

2.Iodine Nutrition of the Population

3.Impact of Iodine Deficiency on the Population

4.Policy Environment

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

1.Product (salt) Monitoring

2.Progress in Iodine Nutrition (impact) Monitoring

3.The Quality of the Process

V.Recommendations

1.Product (Salt) Monitoring

2.Impact/Progress Monitoring

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

4.Next Steps

Annexes

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.

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 (USI[1]) in country after country is resulting in striking increases in the numbers of newborns in the world being protected against brain damage from iodine deficiency[2].

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.

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 dayfor 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 foetus[4], 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 pregnancy[6] 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 deficiency[7].

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 Deficiency[8]

• 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 conditions and a six month shelf-life expiry date[9]. 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, 2002[10] stipulated universal iodisation, at a level of 20 + 5ppm iodine (in the form of KIO3 or KI), of all food grade salt[11], 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.

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 increasing[12] 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 iodine[13].

a)Production level

The National Salt Company of Romania – SALROM[14] - 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 finance[9]). 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.

1. 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 salt[15]. In the first 5 months of 1999 about 30% (43,000 MT) of all food grade salt was reported to be iodised.
2. According to the 2003 note from SALROM[10] 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.
3. 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.

1. 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.