IODINE DEFICIENCY DISORDERS - PDF document

IODINE DEFICIENCY DISORDERS Assessment ofIodine Deficiency Disordersand Monitoring their EliminationA guide for programme managersSecond edition IODINE DEFICIENCY DISORDERS © WORLD HEALTH ORGANIZATION, 2001and all rights are reserved by the Organization. The document may, however, befor sale nor for use in conjunction with commercial purposes. The views expressed IODINE DEFICIENCY DISORDERS While a variety of methods exists for the correction of iodine deficiency,There are three major components of a sustainable programme tohas been eliminated in a sustainable way.responsibility of the producer, with verification by an external body such asthe national food standards authority. IODINE DEFICIENCY DISORDERS household surveys. They can also be used by salt producers who dorole because it reflects chronic rather than immediate iodine deficiency,but remains useful in the baseline assessment of IDD severity. Thyroidstatus assessment at the community level. Sentinel surveillance may alsothere is evidence of sustainability, as judged by the attainment IODINE DEFICIENCY DISORDERS Chapter Title PageiExecutive summary iiiiiTable of contents viiiList of tablesivList of figures ixvAbbreviations and acronyms xviAcknowledgements xiviiPrefacexii 1Introduction 11.1About this manual 11.2Definitions 31.3Monitoring and evaluatingIDD control programmes 41.4Indicators describedin this manual 5 2IDD and their control, andglobal progress in their elimination 72.1The Iodine Deficiency Disorders 72.2Correction of iodine deficiency102.3Universal salt iodization2.4Sustainability122.5Global progress inthe elimination of IDD172.6Challenges for the future:consolidating the achievement19 IODINE DEFICIENCY DISORDERS Chapter Title Page 3Indicators of the salt iodization process213.1Factors that determine salt iodine content213.2Determining salt iodine levels243.3Monitoring systems25 4Indicators of impact314.1Overview314.2Urinary iodine314.3Thyroid size374.4Blood constituents41 5Survey methods475.1Overview475.2Salt monitoring475.3Iodine status assessment495.4Combined micronutrientdeficiency surveys525.5IDD surveys in areaswith no prevalence data535.6Sentinel surveillance535.7Measuring progress towards achievinglong-term micronutrient goals545.8Target groups for surveillance545.9Interpreting and presenting results55 6Indicators of the sustainableelimination of IDD59 References 63 Annex Title Page 1Titrimetric method for determiningsalt iodate content69 2Method for determining thyroid sizeby ultrasonography71 3Method for measuring urinary iodineusing ammonium persulfate (Method A)73 4Methodology for selectionof survey sites by PPS sampling77 5Summarizing urinary iodine data:a worked example85 6Legislation on iodized salt:ASIN Law, The Philippines91 7List of participants: IODINE DEFICIENCY DISORDERS Tables Number Title Page 1The spectrum of the Iodine Deficiency Disorders (IDD) 8 2Current magnitude of IDD by goitreby WHO Region (1999)17 3Current status of salt iodization coverageby WHO Region (1999)18 4Current status of monitoring activities andlaboratory facilities in IDD-affected countries (1999)19 5Epidemiological criteria for assessing iodine nutritionin school-aged children36 6Simplified classification of goitre by palpation39 7Epidemiological criteria for assessing the severityin school-aged children40 8Circumstances when school-basedPPS cluster surveys may not be appropriate51 9Summary of criteria for monitoring progressas a public health problem61 Tables NumberTitle 10Selection of communities in El Sabausing the PPS method 79 11Selection of schoolsusing the PPS method 81 12Selection of schools usingthe systematic selection method 83 13Summary of results 86 14Urinary iodine data in Cameroon schoolchildrenfollowing salt iodization 87 NumberTitle Page 1Social process modelfora national IDD control programme 14 2Components of a routine monitoring system for USI 29 3Programme monitoring and feedback loops 30 4Frequency table and histogram to show distributionof urinary iodine values after iodization in Cameroon 90 IODINE DEFICIENCY DISORDERS PAMMTriiodothyronineTotal goitre rateUnited Nations ChildrenÕs Fund IODINE DEFICIENCY DISORDERS vi Charles Todd, who has been closely associated with the development ofof their time to the revision of the manuscript. Special thanks are also due to IODINE DEFICIENCY DISORDERS vii in collaboration with UNICEF and ICCIDDFor these reasons, revision of the document was considered necessary.version of the present text. That version was distributed widely toand eliminate IDD. Over the last decade, intensive efforts have been madeprogrammes. To be fully effective in correcting iodine deficiency, however,iodization site to the household. Such monitoring necessarily involves bothgovernments and the salt industry, requiring close collaboration betweenthe public and private sectors. Hence, this new version emphasizes IODINE DEFICIENCY DISORDERS World Health United NationsChildrenÕs Fund However, the usefulness of urinary iodine to readjust a programme is moreeffective if salt is adequately iodized: ideally, it is the primary role of theis adequately iodized. On the other hand, the measurement of thyroid size ismeant to signal the presence of a public health problem. Blood TSH andFor each impact indicator, this manual provides information on biologicaland the interpretation of results. The statistical methodology employed to carrya programme of IDD control is sustainable. Included in particular are adequatefor policy makers. We hope that the information included in this manual will be IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS1 Universal salt iodization (USI) is defined as when all salt for human and animalconsumption is iodized to the internationally agreed recommended levels. Iodine deficiency, through its effects on the developing brain, has condemnedPeople living in areas affected by severe IDD may have an intelligence quotient(IQ) of up to about 13.5 points below that of those from comparable communitiesimmediate effect on child learning capacity, womenÕs health, the quality of lifeof communities, and economic productivity.Recognizing the importance of preventing IDD, the World Health Assemblyproblem by the year 2000. In 1990, the worldÕs leaders had endorsed this goal as 1 IODINE DEFICIENCY DISORDERS measured. This requires the selection of appropriate indicators of both process is measured and Techniques are then needed to measure these indicators ( they aremeasured). These techniques have to be applied using suitable epidemiological and Finally, the results have to be presented in a digestible format, comparableSpecifically, the objectives of this manual are to describe:on the target population;Target audience ). That document was produced following a consultationthe importance of the process indicators. To continue the battle against IDD4 to 6 May 1999. It involved experts on IDD from all three partner organizations,1.2Definitions refer to all of the ill-effects of iodine deficiencyan adequate intake of iodine. For further details, see section 2. indicator is used to help describe a situation that exists, and can be used is the process of collecting, and analysing on a regular basis, is a process that attempts to determine as systematically andobjectively as possible the relevance, effectiveness, and impact of activities IODINE DEFICIENCY DISORDERS if necessary. In addition, periodic evaluation of health programmes is necessaryrequire an effective system for monitoring and evaluation. The challenge iscosts to a minimum. To this end, it is essential to formulate clearly the questionsvery different. Important questions that will need to be answered include:to the countryÕs requirements?Answering these questions requires different approaches to gathering data.survey. IODINE DEFICIENCY DISORDERS 1.4Indicators described in this manual lag behind changes in iodine statusare regarded as evidence of sustainability. IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS 1 global progress in their elimination2.1The Iodine Deficiency DisordersWHO, UNICEF, and ICCIDD (be able to synthesize sufficient amounts of thyroid hormone. The resultingharmful effects known collectively as the Iodine Deficiency Disorders (simply goitre and cretinism (see Table 1). IODINE DEFICIENCY DISORDERS Table 1: The spectrummental deficiency, deaf mutism,mental deficiency, dwarfism, hypothyroidismNEONATEADULT Normal levels of thyroid hormones are required foroptimal development of the brain. In areas of iodine deficiency, where thyroidhormone levels are low, brain development is impaired.cognitive capacity which affect the entire population. As a result, the mental IODINE DEFICIENCY DISORDERS Thus, the potential of a whole community is reduced by iodine deficiency.Indeed, everybody may seem to be slow and rather sleepy. The quality of lifeis poor, and ambition blunted.The community becomes trapped in a self-perpetuating cycle. Even thedomestic animals, such as the village dogs, are affected. Livestock productivitybeing signalled by certain geographical characteristics. These include mountainHowever, the greater availability of urinary iodine estimation and other methods IODINE DEFICIENCY DISORDERS 2.2Correction of iodine deficiencythe salt supply. Most humans eat salt in roughly the same amount each day. as well ascountries. At this stage, however, sustainability of this successful correctiondirect administration of iodine solutions, such as LugolÕs iodine,of hypothyroidism due to iodine deficiency. Such an increase in vitality isperformance of adults, and a better quality of life. The economic significance IODINE DEFICIENCY DISORDERS producers. Otherwise, a successful programme will lapse, as has occurred2.3Universal salt iodizationthat the most effective way to achieve the virtual elimination of IDD is throughin the food industry. Adequate iodization of all salt will deliver iodine in the this phase ensures infrastructure IODINE DEFICIENCY DISORDERS government ministries (legislation and justice, health, industry,reaching the IDD elimination goal and sustaining it forever.eliminated. Protecting consumers requires that a framework be established of the private salt marketingsystem, the government, and civic society. The establishment and maintenanceA guideline has been developed as a useful tool to aid the review of all aspects). This guideline, however,2.4Sustainabilityposes the issue of sustainability. Indeed, sustainability is absolutely critical.IDD cannot be eradicated in one great global effort like smallpox and,hopefully, poliomyelitis. Smallpox and poliomyelitis are infectious diseases IODINE DEFICIENCY DISORDERS deficiency of iodine in soil and water. IDD can therefore return at any timeafter their elimination if control progammes fail. Indeed, there is evidence thatiodization, or still have some distance to go, the vital message is clear.or willing to act. Political support is essential for the passage of laws orThe National Body responsible for the management of the IDD controlprogramme should operate with a process model. A useful example of such a IODINE DEFICIENCY DISORDERS Figure 1: Social process model for a national IDD control programmeand legislative authority to carry it out. This model, which is described in detailImplementation Salt iodine Proposal support IDD control IODINE DEFICIENCY DISORDERS The social process involves six components, clockwise in the hub of the wheel. Dissemination of findings to health professionals and the public, so that there is full understanding of the IDD problem and the potential benefits of elimination. needs the full involvement of the salt industry.systems reach all affected populations, including the neediest.salt technology, laboratory methods, and communication.efficient system for the collection of relevant scientific data onspecial difficulties in implementation. Experience indicates that particulartheir different professional orientations. There is need for mutual educationabout the health and development problems of IDD, and about the problemsby an educated community. This will greatly assist sustainability. IODINE DEFICIENCY DISORDERS in the fetus and in the young infant when the brain is growing rapidly. Whether amount of iodine to theiodine (at the factory, retail, and household levels) and urinary iodineelements for monitoring whether IDD is being successfully eliminated. Thesemeasurements must be carried out regularly, according to the proceduresAccordingly, appropriate measures can be taken, if necessary, to ensure thenormal range of intake of iodine. All these procedures require internal and laboratories which are available at the country and regional levels with some support from international laboratories for quality control: at theMoney, trained manpower, equipment, and materials are also required toimplementation of salt iodization and the establishment of IODINE DEFICIENCY DISORDERS National/provincial programmes salt usage content with test kits, backed by Test urinary iodineTarget salt consumption GovernorÕs Office, District Medical Officers, midwives, teachers, volunteers, etc.which result in feedback, which aids and reinforces their activities. Similarly, and feedback loops resources Feedback from actionsto programmes and monitoringCommunity-level monitoring2 IODINE DEFICIENCY DISORDERSFinally, the occurrence of parallel markets in uniodized salt has frequently beena barrier to achieving universal salt iodization. National cross-sectional of a in factories results byWarning facturing practices assurance recordsTitration purchasing quality product, packed in IODINE DEFICIENCY DISORDERS methods). A household questionnaire concerning the use of iodized saltand census data. These surveys provide estimates of the proportion of thewhere they are most needed. This type of monitoring should then be followedshould result in a range of actions to correct the problem. Survey approachessurveys. This approach may be organized in the community or through theschools, particularly in areas with high rates of school enrolment. Providing IODINE DEFICIENCY DISORDERSstep. This area includes not only the actual iodization method chosen by aproduction or packaging facility, but also the assurance that the producer closelyshould be taken on a periodic basis for salt titration. The iodine concentration plotted in a quality assurance chart. Whenlevels are not satisfactory, immediate corrective action should be taken andBecause production methods and factory sizes vary so widely, it is beyondthat corresponds to that indicated on the label. That level should, of course,correspond to the level allowed for under the law.market. This implies that they should have a quality assurance system thatown iodization facility. All salt should be distributed in polyethylene bags, IODINE DEFICIENCY DISORDERS the Health Ministry. In other countries, the Ministry of Industry, or Mines,or Agriculture has this responsibility. In the case of importation of salt,with titration. Government inspection systems need to have access to andto comply with the law.realization of elimination of IDD. Indeed, as the coverage of iodized saltincreases, special efforts need to be made to identify the non-compliantimporter, producer and distributor and systematically eliminate that problem.Salt must be iodized indefinitely, or until it is demonstrated that an adequateiodine intake is available from other sources. The infrastructure, together withpermanently established. In order to guarantee this, it is essential thatsystem in the country.own facility, as each has its own unique characteristics.The Ministry of Industry, the Bureau of Standards, or Codex Alimentarius are IODINE DEFICIENCY DISORDERSindication that salt actually is iodized. Accordingly, they can be used fordemonstration purposes in schools and other institutions. However, becauseThere are a large number of test kits available on the market; moreover, manycountries are currently producing their own. UNICEF also supplies countries However, a comprehensive review to assess these kits is still3.3Monitoring systemsExternal monitoring systems by governmentsregulations. Guidelines for developing regulations are available (Other legal requirements should include packaging in polyethylene bags,content. Although monitoring at the production and household levels isthat all sources of salt have been identified. Several monitoring andinspection systems have emerged in different countries.Test kits can be obtained by directing requests to MBI, 85 GN Chetty Road, III Floor,T Nagar, Madras 600 017, India. IODINE DEFICIENCY DISORDERS 3.2Determining salt iodine levelsindicator. The method of liberating iodine from salt differs depending on whetherlaboratory. Large- and medium-scale salt producers should carry out titrationTitration is preferred for accurate testing of salt batches produced in factoriesor upon their arrival in a country, and in cases of doubt, contestation, etc.is required. Once the method is established, it is necessary to adhere to properinternal and external quality control measures. However, the titration methodthroughout the country.solution. One drop of the solution placed on salt containing iodine (in the formof potassium iodate) produces a blue/purple coloration. These kits shouldreliably determined. In cases where there is suspicion of alkalinity in the salt IODINE DEFICIENCY DISORDERS However, in some instances the quality of iodized salt is poor, or the saltexposure to moisture, heat, and contaminants. Iodine losses from point ofproduction to consumption can then be well in excess of 50%. In addition,salt consumption is sometimes much less than 10 g per person per day. As ag/l). If not, the level ofiodization of salt, and factors affecting the utilization of iodized salt, should befactors affecting iodine losses from salt, such as packaging,with the salt industry, taking into account expected losses and local saltprogramme is having the desired effect. or KI).and facilitates comparison of its different forms. IODINE DEFICIENCY DISORDERS A recent laboratory study (with tropical and subtropical climates. The study showed that high humidity,range of 10-15%) by using packaging with a good moisture barrier, such aslow-density polyethylene (LDPE) bags. However, longer storage - beyondsix months - aggravated losses. Therefore, it is recommended that the timeresistance to puncture. Woven high-density polyethylene (HDPE) bags,average salt intake is 10 g per person per day, (i.eg of iodine per person per day. The iodine should be added aspotassium (or sodium) iodate. Under these circumstances median urinary IODINE DEFICIENCY DISORDERS 3.1Factors that determine salt iodine content The stability of iodine in salt and levels of iodization are questionsthey have implications for programme effectiveness, safety, and cost. Indicators of the saltiodization process than potassium iodide because of its greater stability, particularly in warm, damp, ortropical climates. In addition, no data are available indicating toxicological hazard fromthe ingestion of these salts below the level of Provisional Maximum Tolerable Daily IODINE DEFICIENCY DISORDERS or through working with a common distributor, thus reducingof IDD. Ensuring this salt is iodized also means eliminatingis as important as the provision of clean water. There is adequate knowledgeof existing technology. The achievement of the sustained elimination of IDD IODINE DEFICIENCY DISORDERS Table 4: Current status of monitoring activities andlaboratory facilities in IDD-affected countries (1999)Africa 44292428The Americas 19191919South-East Asia 9 8 7 6Europe 32171313 Mediterranean 171410 11Western Pacific 9 8 6 7Total 130957984Per cent 100%73%61%65%* These figures reflect countries with the capacity for both urinary iodine and/orsalt iodine level analyses. Standard of laboratories and expertise for each of these,however, is very different.2.6 Challenges for the future: consolidating the achievementresources to ensure effective iodization. Producer compliance,addressed through effective advocacy and social communications. IODINE DEFICIENCY DISORDERS ). Of the 130 countries with IDD, 98 (75%) now havesalt industry, there has been an enormous increase in the consumption ofiodized salt. The latest data for each of WHOÕs Regions are summarized inTable 3.Table 3: Current status of salt iodization coverageAfrica 63%The Americas 90%South-East Asia 70%Europe27%Eastern Mediterranean Western Pacific76% Overall 68%Source: adapted from WHO, UNICEF, ICCIDD. Progress towards elimination*Total population of each country multiplied by the percentage of householdswith access to iodized salt. Numbers then totalled for each Region and dividedby the total population of that Region.sustainability of IDD control programmes. The latest data from the sameRegions, are summarized in Table 4. IODINE DEFICIENCY DISORDERS 2.5Global progress in the elimination of IDDIDD problem. A total of approximately 740 million people were affected by). Given that goitre representspopulation suffers from IDD and, in particular, from some degree of mentalcentury, the last decade has seen the greatest progress. That progress hasIn spite of this progress, however, the estimated number of the total affectedTable 2: Current magnitude of IDD by goitreAfrica 612 124 20%The Americas 788 39 5%South-East Asia 1477 172 12%Europe 869 130 15%Eastern Mediterranean 473 152 32%Western Pacific 1639 124 8%Total 5858 741 13%Source: WHO Global IDD Database (to be published).*Based on UN Population Division estimates, 1997. IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERSincreased serum Tg levels. In this setting, it reflects iodine nutrition over aperiod of months or years. This contrasts to urinary iodine concentration,deficiency, particularly goitre. The laboratory technique is similar to that forTSH and other immunoassays. It has been successfully applied to bloodcommercially or studied further. IODINE DEFICIENCY DISORDERS to assess community iodine deficiency. Less expensive means for obtainingbudgets are low. In such countries, mortality among children under five is highcountries. Most have been carefully standardized, and perform adequately.deficiency.countries. Other than infrequent cases of goitrogen exposure, iodineof iodine deficiency. It may be higher than 40% in severe endemic areas.delivery or even the umbilical area of the baby. Beta-iodine increases TSH4.4.2Thyroglobulin (Tg)for thyroid hormone synthesis. Normally, small amounts are secreted or leakfrom the thyroid into the circulation. When the thyroid is hyperplastic or IODINE DEFICIENCY DISORDERSTo detect congenital hypothyroidism and initiate rapid treatment, mostTSH elevations which are 20 mIU/l whole blood or higher, the availability ofnormal. This permits detection of transient hyperthyrotopinemia. To be broadlychildren born in remote or impoverished areas. For countries and regions thatfor both hypothyroidism and hyperthyroidism. Methods for determining TSHserum, are well established and widely available. Typically, a few drops ofobjects contaminated with blood should be followed. The risk of contractingHIV or hepatitis infection from dried blood spots is extremely low.cord blood are higher than those for heel prick blood. Blood spots, once dried,are stable. They can be stored in a plastic bag and transported even throughwill be a spin-off. Hence the only additional cost will be for data analysis. IODINE DEFICIENCY DISORDERS In iodine deficiency, the serum T4 is typically lower and the serum T3 higherthan in normal populations. However, the overlap is large enough to make4.4.1Thyroid stimulating hormone (TSH)The pituitary secretes TSH in response to circulating levels of T4. The serumTSH rises when serum T4 concentrations are low, and falls when they arehigh. Iodine deficiency lowers circulating T4 and raises the serum TSH,However, the difference is not great and much overlap occurs betweenindividual TSH values. Therefore, the blood TSH concentration in school-agechildren and adults is not a practical marker for iodine deficiency, and itsIn contrast, TSH in neonates is a valuable indicator for iodine deficiency.and hence iodine turnover is much higher. This high turnover, which isexaggerated in iodine deficiency, requires increased stimulation by TSH.indicator of the severity of iodine deficiency in a given population. It has theIn iodine sufficient populations, about 1 in 4000 neonates has congenitalhypothyroidism, usually because of thyroid dysplasia. Prompt correction with IODINE DEFICIENCY DISORDERScurrently costs about US $15,000. A source of electricity is needed, and thethe same age in different countries. This approach was considered potentiallyrequired, which in some populations is not known with certainty. A limitation of4.4Blood constituentsTwo blood constituents, TSH (thyroid stimulating hormone or thyrotropin)and thyroglobulin (Tg) can serve as surveillance indicators. In a populationsurvey, blood spots on filter paper or serum samples can be used to measureultrasound in school-aged children. The model has already been tested and is still IODINE DEFICIENCY DISORDERS Table 7 gives the epidemiological criteria for establishing IDD severity, basedbe used to signal the presence of a public health problem. This recommendationthe prevalence of goitre should be quite low. The cut-off point of 5% allows bothTable 7: Epidemiological criteria for assessing Degrees of IDD, expressed as percentage of the total of the number of children surveyed None Mild Moderate Severe Total goitre 0.0-4.9%5.0-19.9%20.0-29.9%may not return to normal for months or years after correction of iodine deficiency.4.3.2 are expected to decrease over time. In the future, ultrasonography is poisedto become widely used to assess IDD. The technical aspects of thyroid IODINE DEFICIENCY DISORDERS Finally, the examiner palpates the thyroid by gently sliding his/her own thumbIf necessary, the subject is asked to swallow (e.g. some water) when beingexamined - the thyroid moves up on swallowing. The size of each lobe of the Goitre is graded according to the classificationpresented in Table 6.Table 6: Simplified classification of goitre* by palpationnot enlarged fall into this category. Another method is to stand behind the subject with the neck in the neutral positionand hold the fingers (not thumb) over the area of the gland. The person is asked toswallow and the gland is palpated by the fingers as it glides up. This is repeated on IODINE DEFICIENCY DISORDERS but much less so in determining impact. Costs are associated with mountinga survey, which is relatively easy to conduct, and training of personnel. Thesecosts will vary depending upon the availability of health care personnel,accessibility of the population, and sample size. Feasibility and performance It is neither feasible nor practical to assess goitre amongneonates, whether by palpation or ultrasound. Performance is poor.easily accessible. However, the highest prevalence of goitre occurs duringThe smaller the child, the smaller the thyroid, and the more difficult it is tomay not be representative. In these cases, spot surveys should be conductedAlternatively, children can be surveyed in households. For further discussion, Pregnant and lactating women are of particular concern. Pregnantespecially sensitive to marginal iodine deficiency. Often they are relativelyaccessible given their participation in antenatal clinics. Women of childbearingTechniqueThe subject to be examined stands in front of the examiner, who looks carefully IODINE DEFICIENCY DISORDERS). This occurs more commonly in older subjects). Beyond this period of time, median4.3Thyroid sizeUltrasonography provides a more precise and objective method. However,Both methods are described below. Issues common to palpation and ultrasound4.3.1 Thyroid size by palpationdepending on many factors. These include the severity and duration of iodinedeficiency, the type and effectiveness of iodine supplementation, age, sex,goitre and is still recommended (see Table 6). IODINE DEFICIENCY DISORDERS Table 5: Epidemiological criteria Median Iodine intake Iodine nutrition InsufficientSevere iodine deficiency 20-49InsufficientModerate iodine deficiency 50-99InsufficientMild iodine deficiency100-199Adequate200-299More thanRisk of iodine-inducedadequatehyperthyroidism within&#x 20-;㦘 300ExcessiveRisk of adverse healthwhereas thyroid size reflects iodine nutrition over months or years. Therefore,even though populations may have attained iodine sufficiency by medianWith rapid global progress in correcting iodine deficiency, examples of iodineand poorly monitored (). Tolerance to high doses of iodine is quite variable, IODINE DEFICIENCY DISORDERSMost of the above methods perform reliably, although some of the newer onesneed further testing as of this date. All these methods routinely recognizerange is desired. The coefficient of variation is generally under 10% for allSince casual specimens are used, it is desirable to measure a sufficienta reasonably narrow confidence interval (see Annex 4). In general, 30 urinedeterminations from a defined sampling group are sufficient.at low cost and to characterize the distribution according to different cut-offpoints and intervals. The cut-off points proposed for classifying iodinenutrition into different degrees of public health significance are shown inTable 5.Frequency distribution curves are necessary for full interpretation. Urinaryiodine values from populations are usually not normally distributed. Therefore,tendency. Likewise, percentiles rather than standard deviations should bepopulation which has no iodine deficiency, i.e. at least 50% of the sampleg/l. In addition, not more than 20% of samples shouldAlternatively, the first quintile (20th percentile) should be at least 50 IODINE DEFICIENCY DISORDERS Other methods sealed cassettes and heated to 110 reduction reaction carried out and read on a microplate reader.analysed in one day, depending on manufacturersÕ supplies.Criteria for assessing urinary iodine methods are reliability, speed, technicalsuppliers, safety, and cost. The choice among the above and other methodsdepends on local needs and resources. Large central laboratories processingDue to the potential hazards of chloric acid, Method A using ammoniumpersulfate is currently recommended. It can adequately replace the chloricpersulfate for chloric acid in the digestion step (see Annex 3). Results arein place, and should be open to external audit. In addition, all laboratoriesa recognized reference laboratory.Active efforts are now in progress, both to define performance criteria forlaboratories and to develop a global system of reference laboratories. Theseand will conduct technical training and supervision. This initiative is a majorpriority for ensuring sustainability of iodine sufficiency. IODINE DEFICIENCY DISORDERS Methods with ammonium persulfate (Method A)persulfate at 90-110 ). This method requires a heating blockand a spectrophotometer, which are both inexpensive instruments.). A disadvantage is the safety concern, because Handling these chemicals in a fume cupboard and using (see Annex 3). below 50 can be adjusted to desired levels. This method is currentlyAnother, semi-quantitative method is based on the iodide-catalyzedactivated charcoal. Analyses must be run within two hours, andthe procedure requires the manufacturerÕs pre-packed columns. IODINE DEFICIENCY DISORDERS adequate assessment of a populationÕs iodine nutrition, provided a sufficientnumber of specimens is collected. Twenty-four hour samples are difficult toobtain and are not necessary.unnecessary. Indeed, urinary iodine/creatinine ratios are unreliable,low.to obtain. Urinary iodine assay methods are not difficult to learn or useiodine at all stages. Special laboratory areas, glassware, and reagents shouldIn general, only small amounts (0.5-1.0 ml) of urine are required, although theexact volume depends on the method. Some urine should also be kept inreserve. Samples are collected in tubes, which should be tightly sealed withscrew tops. They do not require refrigeration, addition of preservative, orimmediate determination in most methods. They can be kept in the laboratoryfor months or more, preferably in a refrigerator to avoid unpleasant odour.can be used in regional, country, or local laboratories. Most methods dependacid (the Sandell-Kolthoff reaction). A digestion or other purification step usingis presented in the following pages. IODINE DEFICIENCY DISORDERS Indicators of impact4.1Overviewassessing IDD prevalence. However, because of the long response time afterhas been a significant development. However, this approach requires costlyequipment and a source of electricity in the field. Moreover, there are as yetTwo other indicators are included in this discussion: thyroid stimulating hormonesensitive to iodine deficiency, difficulties in interpretation remain. Furthermore,4.2Urinary IodineMost iodine absorbed in the body eventually appears in the urine. Therefore,even within a given day. However, this variation tends to even out among IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS annexes IODINE DEFICIENCY DISORDERS 29. Ohashi T et al. A newly developed method for determination of urinary30. Stanbury JB et al. Iodine-induced hyperthyroidism, occurrence andepidemiology. 8 (1): 83-100.31. Todd CH et al. Increase in thyrotoxicosis associated with iodine Lancet32. Delange F, Bourdoux P, Ermans AM. Transient disorders of thyroidfunction and regulation in preterm infants. In: Delange F, Fisher D,Malvaux P, eds. . Basel, S. Karger, 1985:369-393.33. Missler U, Gutekunst R, Wood WG. Thyroglobulin is a more sensitiveBiochemistry,34. UNICEF, PAMM, MI, ICCIDD, WHO. Sullivan KM et al., eds. 2nd ed. UNICEF, PAMM, 2000.37. Dean AG et al. Epi Info, Version 6: a word processing, database, IODINE DEFICIENCY DISORDERS19. WHO, UNICEF, ICCIDD. Geneva,Development, World Health Organization, 1211 Geneva 27, Switzerland).from India. In: Geertman RM, ed. Volume 2. 8th World SaltSymposium. The Hague, 8-11 May 2000. Amsterdam, Elsevier, 2000:21. Delange F, de Benoist B, Alnwick D et al. Risks of iodine-induced 2nd ed.Atlanta, PAMM, 1995.programs. Report of a Training Workshop. Blantyre, Malawi 9-13 March Atlanta, PAMM, 1998.25. UNICEF, ICCIDD, PAMM, WHO, MI. Sullivan KM et al., eds. . Atlanta, PAMM, MI, ICCIDD, 1995.. The Netherlands,28. Dunn JT, Myers HE, Dunn AD. Simple methods for assessing urinary IODINE DEFICIENCY DISORDERS 10. Delange F. The disorders induced by iodine deficiency. 11. Pandav CS, Rao AR. 12. MI, WHO, ICCIDD, USAID, PAMM, UNICEF. Houston R et al., eds.salt program assessment tools (ISPAT).13. WHO, UNICEF, ICCIDD. Delange F et al., eds. deficiency disorders in Central and Eastern Europe, the Commonwealthof Independent States, and the Baltic States. Proceeding of a Conferenceheld in Munich, Germany, 3-6 September 1997. Geneva, World HealthDevelopment, World Health Organization, 1211 Geneva 27, Switzerland).14. WHO, UNICEF, ICCIDD. Geneva, World Health Organization, 1999Department of Nutrition for Health and Development, World HealthOrganization, 1211 Geneva 27, Switzerland).15. WHO, UNICEF, ICCIDD. Geneva, World Health Organization, 1993 (MDIS WorkingReport of the Joint FAO/WHO Expert Committee on Food Additives.Geneva, World Health Organization, 1991 (WHO Technical Report Series,17. MI, ICCIDD, UNICEF, WHO. Mannar V, Dunn J, eds. Salt iodizationfor the elimination of iodine deficiency. The Netherlands, ICCIDD, 1995. IODINE DEFICIENCY DISORDERS Referencesand its relationship to cognitive development. In: Stanbury JB, ed.The damaged brain of iodine deficiency. New York, Cognizant2. WHO, UNICEF, ICCIDD. Indicators for assessing iodine deficiency Geneva, World HealthWorld Health Organization, 1211 Geneva 27, Switzerland).3. Last JM, ed. Dictionary of epidemiology, 3rd ed. New York,International Epidemiology Association, Oxford University, 1995.4. WHO, UNICEF, ICCIDD. Geneva,Development, World Health Organization, 1211 Geneva 27, Switzerland)., 1983, 2:1126-1129. Delong GR. Observations on the neurology of endemic cretinism.New York, Plenum Press, 1989:231ff.7. Delange F. Endemic cretinism. In: Braverman LE, Utiger RD, eds.The thyroid. A fundamental and clinical text. 8th ed. Philadelphia,2nd ed. New Delhi, Oxford University Press, 1996.9. Dunn JT. WhatÕs happening to our iodine? IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS Table 9: Summary of criteria for monitoring progressIndicatorsGoa Proportion of households using adequately iodized salt�90%* Proportion below 100 g/l Proportion below 50 g/l Attainment of the indicatorsAt least specified on the opposite page8 of the 10WHO, UNICEF, ICCIDD, and other appropriate organizations. Such externalcountry programme. Partnership evaluation can also provide programmes IODINE DEFICIENCY DISORDERS the elimination of IDD (this council should be multidisciplinary,the salt industry, the media, and consumers, with a chairmanappointment of a responsible executive officer for the IDDregular data on salt iodine at the factory, retail and IODINE DEFICIENCY DISORDERS (see also Table 9). availability and consumption of adequatelyits use by more than 90% of households. Preconditions for the use of thisin a quantity that is sufficient to satisfy the potential IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS at the national level, it isthe overall result obtained may be biased. Rather, the following guidelines Results from prevalence surveys in different regions should be weighted according to population size, before combining them. For example, goitre prevalence data should be adjusted by the size of the total study population. The total enrolment of all schools in the region, or the total population of the region, should be usedshould be treated in a similar way. (These are both numericalas such. Instead, the median of medians from each sentinel IODINE DEFICIENCY DISORDERS of variability, or spread of the distribution. Unfortunately, many IDD parametersare not normally distributed. Rather, the results may be highly skewed in onetypically skewed to the right (positively skewed). The upper tail of the distributionis longer than the lower tail. In such cases, the use of means and standardthe measure of central tendency. The median is the same thing as thehalf are below. It is equidistant from either extreme.involves the use of selected percentiles. The value of the 20th and 80thsense of shape to the distribution of values. However, it has been customaryg/l). After iodine prophylaxis has been introduced, it may also be helpfulIt is important not to overinterpret the results obtained. For example, it is ag/l are iodine deficient. If the median is 100 the values will be below this level. Individual spot urine iodine values are likelyIt should be noted that in carrying out a survey, only a sample of individualsis examined - not the entire population. There will therefore inevitably be adegree of sampling error in the results obtained. This is decreased - but notpopulation value is likely to lie. Ninety-five percent confidence intervals can be IODINE DEFICIENCY DISORDERSWomen of childbearing age: Screening women aged 15-44 years providesdeficiency. However, after age 30 goitre rates are no longer reliable indicatorsand logistical constraints associated with performing such surveys. In ruralareas, women may go to the fields during the day. In some countries, many Neonatal screening to identify congenital defects is wellrelatively prosperous developing countries. Regular collection of blood-spotElevated TSH levels, especially during infancy, suggest a deficiency of iodine.However, this approach is recommended for monitoring IDD control only when5.9Interpreting and presenting resultsTaken alone, raw results from a survey do not mean very much. They must beprocessed and analysed. If there is a small number of results, for example100 or so, then processing by hand is fairly easy. With large numbers of data,easier.Data should be entered using a suitable programme. Possibilities include asampling. Theoretically, data should be importable from one to the other,but in practice this is not always easy. IODINE DEFICIENCY DISORDERS the early stages of an IDD control programme. Once the situation appearsIt is, however, important to be flexible when establishing a system for monitoringIDD control. For example, if there are reports of persistent goitre in a particular5.7Measuring progress towards achievingPeriodic prevalence surveys, as described earlier in this section, are necessaryto measure change in prevalence over time. Measuring progress towards5.8Target groups for surveillance: School-aged children are a useful target group forIDD surveillance because of their combined high vulnerability, easy access,and applicability to a variety of surveillance activities. Affected childrenestimates (see Table 8). If school enrolments or attendance are low, IODINE DEFICIENCY DISORDERS5.5IDD surveys in areas with no prevalence dataof IDD being suspected or predicted in that particular location. Factorsoutlined in Chapter 1. The most useful type of survey for this purpose isGoitre palpation of each subject takes very little time. The examination of aof goitre rates. This is particularly important if no estimate of overall goitreor the entire enrolment if this is a lower number. For instance, assessment ofprevalence is 50%, but 234 children if the latter percentage is 20%. In addition,5.6Sentinel surveillanceto be used as an instrument for the regular monitoring of IDD control. To assess. Such districts are chosen on the basis of their being remotefor surveying. An urban area should also be included to act as a control,samples should be collected as outlined above. If resources are limited, IODINE DEFICIENCY DISORDERS In a school survey, the thirty children selected for urine collection should bechosen by systematic random sampling. Only children between the ages of 6IDD prevalence survey is performed. If possible, advance notice should beschool on the day in question. If advance notice is not given, ten salt samplesIn a household survey, the team should identify the centre of the chosenshould be selected. Each house should be visited according to the direction5.4Combined micronutrient deficiency surveysIDD prevalence surveys may be efficiently combined with those aimed atsalt sample at the same time. Alternatively, the nearest school to the selected IODINE DEFICIENCY DISORDERS Table 8: Circumstances when school-basedReason EffectRecommended actioncome from better offdifference proceed IODINE DEFICIENCY DISORDERS selected on the basis of simple random sampling. The final result is thenactually enrolled in the schools selected for the survey.Within each cluster, a specified number of school-aged children or adult womenare selected for study. Each selected subject provides a urine specimen and thirty samples of both urine and salt per cluster are generally. Selection of at least 30 samples allows for inference at theefficient and practical approach for performing an iodine status or an IDDprevalence survey. However, school-based PPS cluster surveys may not beappropriate under all circumstances, as shown in Table 8.One 30-cluster survey is not sufficient for all countries, particularly those withlarge populations or those that are spread over a wide area. For example,carried out in each. Frequently a country is divided into subnational units,survey. IODINE DEFICIENCY DISORDERSSalt samples should be collected at the household level during periodic surveys5.3Iodine status assessment). This method has been in use for many years for the evaluationThese notes are intended as a general guide to the principles underlying theconduct of such surveys. Surveys are expensive, and the issues of samplesize and selection of sites must be given very careful consideration. It isrecommended that expert epidemiological help be sought at an early stage inpopulations. For IDD surveys, the sampling unit should be either communitiesor schools. In the latter case, a list of the enrolments (total number of pupils) oflikely to be selected than smaller ones. Each selected sampling unit is onecluster. In a defined geographical area, thirty clusters should be studiedcan lead to estimates that differ substantially from the true prevalence ( IODINE DEFICIENCY DISORDERS within a specified range. Such producers should seek certification by theAt the actual point of entry, customs officers can realistically be expectedall imports to check that the salt is suitably packed and labelled. Eachany kind of representative sampling. Suspect salt should be held at the border.However, it should be noted that salt may be imported for industrial purposesan attractive option, but is difficult to implement in practice. Unloading bagsfrom a lorry or railway wagon to check a consignment thoroughly is difficult,and retail premises to ensure compliance with food regulations. During theseAll salt samples should be carefully labelled before dispatch to the laboratory.Where a specific producer consistently fails to comply, appropriate legal steps IODINE DEFICIENCY DISORDERS 5.1Overview of salt iodization alone. monitoring and evaluating of salt iodization ontarget communities. In practice, during surveys at schools or in households,Attention to survey methods is important. It will help both to ensure that subjectsstudy population, and that the surveys are carried out as efficiently as possible.5.2Salt monitoringSalt monitoring at the site of production is the responsibility of the salt producer.by titration. A modified Lot Quality Assurance Sampling (LQAS) scheme is IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS for Health and Development1211 Geneva 27, SwitzerlandTel: 41 22-791.3322World Health Organization20 Avenue Appia, 1211Tel: 41-22-791.3412G. A. Clugston, Director20 Avenue Appia, 1211Tel: 41-22-791.3326A. Verster, Director for the Eastern MediterraneanNasr City, Cairo 11371, EgyptTel: 202-670-25-35 IODINE DEFICIENCY DISORDERS M.G. Karmarkar, Senior AdviserNew Delhi 110029, IndiaTel: 91-11-371.0726Fax: 91-11-686.3522 Health and Director of PAMMTel: 1-404-727.4553E-mail: gmaberl@sph.emory.eduC. Pandav, Regional CoordinatorNew Delhi 110029, IndiaTel: 91-11-649.2693Fax: 91-11-686.3522Avenue Cuba 523Lima 11, PeruTel: 51-1-265.9118E-mail: epretell@per.itete.com.peTel: 1-404-727.5846E-mail: cdckms@sph.emory.eduJ.W. SchultinkSenior Adviser, MicronutrientsNew York, NY 10017, USATel: 1-212-326.7000C. Todd, Regional Health Adviser European Commission in ZimbabweP.O. Box 4252Tel: 263-4-701914-5 ext. 203 charles.todd@delzwe.cec.eu.int IODINE DEFICIENCY DISORDERS F. Azizi, Director of Medical Sciences and Health ServicesP.O. Box 19395-4763Teheran, Islamic Republic of IranTel: 98-21-2409301-5Tel: 41-32-622.0302 to Ministry of Public HealthTianjin Medical CollegeTianjin 300070Tel: 86-22-2352.5608F. Delange, Executive Director153, Avenue de la Fauconnerie1170 Brussels, BelgiumTel: 32-2-675.8543A. Duffiel on Coordinationc/o WHO, 20 Avenue Appia1211 Geneva 27, SwitzerlandUniversity of VirginiaP.O. Box 511Charlottesville, VA 22908, USATel: 1-804-924.5929E-mail: jtd@avery.med.virginia.eduTel: 61-8-8267.3768E-mail: iccidd@a011.aone.net.auP. Jooste, Chief Scientist for Nutritional InterventionP.O. Box 19070Tygerberg 7505Tel: 27-21-938.0370E-mail: pieter.jooste@mrc.ac.za IDD Consultation, Geneva 1999 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS a)direct sunlight or near source of strong lightb)high temperature and humidityc)contamination with moisture e.g. rain, flood, etc.d)contamination with dust or filth from the environmentReferenceAn Act Promoting Salt Iodization Nationwide and for Related Purposes (ASIN LAW) and its Implementing Rulesand Regulations. Published by the Nutrition National Council. Printed in the Republic of the Philippines. 1996. IODINE DEFICIENCY DISORDERS 5.1All additives used, including KIOspecifications prescribed by JEFCA or the Food Chemicals Codex. Permitted additives for iodized salt are Maximum level in the final prod5.2.1 Coating agents; Carbonates, 20 g/kg singly ort in combination (for 5.2.1 and 5.2.2)Calcium/magnesium, Magnesium oxide; Tricalciumphosphate; Silicon oxide, amorphous; Silicates of calciumpotassium or sodium 10 mg/kg singly or in combination expressed as [Fe(CN 5.3 Emulsifiers Polysorbate 80 10 mg/kg 5.4 Processing aid Dimethylpolysiloxane 10 mg of residue/kg7.1Iodized salt for commercial distribution shall carry appropriate labeling in accordance with BDADrules and regulations on labeling of prepackaged foods. Specifically, the following information shall be a)The name of the product, ÒIODIZED SALTÓ, printed in bold capital lettersb)Name and address of manufacturerc)Net weight (in metric units)d)Iodine compound usede)Chemical additives e.g. anticaking agents, emulsifiersf)Open date marking e.g. ÒBest BeforeÓ or ÒConsume BeforeÓ Dateg)Lot Identification Code (Repackers must use manufacturesÕs lot i.d. code)h)Storage instruction: STORE IN COOL DRY PLACE a)Same as in 7.1.1 (a), (c) to (h)b)Name and address of importer/local distributorc)Country of origin In the case of non-retail containers of at least 25 kg of iodized salt, the labeling information required insection 7.1.1 (b), (d), (e) or in 7.1.2 (b) may not be declared if such bulk packages are intended for deliveryto distributors/repackers or food manufacturers/institutional users, provided every shipment or delivery isaccompanied by a document containing all the information in 7.1.1 or 7.1.2 IODINE DEFICIENCY DISORDERS STANDARD FOR IODIZED SALTor unrefined (crude) salt obtained from underground rock salt deposits or by evaporation of seawater or naturalbrine. The finished product shall be in the form or solid crystal or powder, white in color, without visible spots ofclay, sand, gravel, or other foreign matters.3.1Salt may be iodized with potassium iodate (KIOa)Dry mixing if salt is in powdered formb)Drip feeding or spray mixing if salt is in crystal formc)Submersion of salt crystals in iodated brine To ensure the stability of iodine, salt to be iodized must conform with the following purity require-Moisture max4% for refined saltNaCl, min97% (dry basis)Calcium and magnesium, max2%Water insoluble, maxArsenic as As0.5 mg/KgCadmium as Cd0.5 mg/KgLead as Pb2.0 mg/KgMercury as Hg0.1 mg/Kg of calcium potassium magnesium chlorides as well. Natural contaminants may also be present in amounts varying Type of containers/PackageSampling PointBulk �(2kg)Retail (Production Site70-150 mg/kg60-100 mg/kgPort of Entry*70-150 mg/kg60-100 mg/kg* For imported iodized salt; also at importerÕs /distributorÕs warehouse IODINE DEFICIENCY DISORDERS SECTION 2. Role Ð The SIAB shall function as the policy and coordinating body on the national saltiodization program and activities. It shall coordinate and monitor all activities concerning the salt iodizationprogram from production and marketing, to public information campaign. It shall analyze the effectiveness of theDOH and other concerned agencies in the implementation of this Act. The SIAB shall submit an annual reportevery end of December to the Congress of the Philippines on the status of the salt iodization program and offerSECTION 1. The BFAD Director is hereby authorized to impose an administrative fine to existing saltproducers/manufacturers/importers/traders based on the applicability of this Act. The provisions of this Act shallbe immediately applicable to salt producers/manufacturers/importers/traders newly established or organized afterthe effectivity of the Act. The LGUs are authorized to impose administrative fine to food service establishmentsand outlets one year after the effectivity of the Act. The administrative fine shall be in the amount of not less thanIn the imposition of the said administrative penalty, the imposable fine of One Thousand Pesos (P1,000.00) toThirty Thousand Pesos (P30,000.00) shall be considered minimum penalty. Thirty One Thousand Pesos(P31,000.00) to Sixty Thousand Pesos (P60,000.00) as medium penalty, and Sixty One Thousand Pesos(P.61,000.00) to One Hundred Thousand Pesos ((P100,000.00) as maximum penalty: provided that the maximumfine shall be in addition to the revocation of the offenderÕs License to Operate, and provided further that in allcases where the subject matter of the offence is a prohibited product, the Director shall order the recall and/orSECTION 2. When the offence is committed with the following circumstances, the minimum penalty shall bea)a history or record of satisfactory compliance with the rules and regulations prior to the commission of theoffence, or absence of previous violation of R.A. 8172 or its IRR; andb)lack of information on the part of the offender about the rules and regulations or requirements of the subjectmatter of the violation/offence.SECTION 3. When the act or omission in violation of R.A. 8172 and its implementation rules andSECTION 4. The medium penalty shall be imposed when the offence committed is not attended by any ofSECTION 5. The BFAD Director may delegate the conduct of administrative investigation of any violationof R.A. 8172 or its IRR to the head of the LGU: provided that the recommendation shall be subject to review andconfirmation by the BFAD Director before the same shall be deemed final and executory. In such case, the LGUmay be authorized by the BFAD Director to collect the fine that may be imposed provided that such fine collectedSEPARABILITY CLAUSEremaining provisions shall not be affected thereby and shall remain valid.These Implementing Rules and Regulations shall take effect thirty days after its publication in a newspaper of IODINE DEFICIENCY DISORDERS c)Assist salt producers/manufacturers obtain soft loan for machines, equipment and other materials suchas fortificant and other chemicals needed to upgrade the salt industry, through its Bureau of Small andd)Provide assistance to salt producers/manufacturers on matters of package design and packaging technologySECTION 4. The Department of Science and Technology (DOST) shall develop and implementaSECTION 5. The Technology and Livelihood Resource Centre (TLRC) shall:a)Assist the DOST in the development and implementation of a comprehensive program for the acquisition of,b)Provide funding assistance to qualified small producers, especially if located in one of the priority provincesin support of the governmentÕs poverty alleviation and industry decentralization drive;c)Develop a program of training entrepreneurs in setting up micro/cottage/small business enterprises to belocated in its Technology and Livelihood Development Centre (TLDC) in the provinces;d)Undertake an all-out information campaign to promote the use of iodized salt nationwide through its tri-SECTION 6. The Cooperative Development Authority (CDA) shall provide assistance to the small andsubsistence salt producers/manufacturers so that they may organize themselves into cooperatives and undertakesalt iodization and marketing of iodized salt in the spirit of cooperativism. The organized cooperatives shall beSECTION 7. The Department of Environment and Natural Resources (DENR) shall provide assistance tofarms. The conversion of such lands into salt farms shall require the concurrence of the landowner and theconcerned agency/entity. The DENR shall ensure, through the Environmental Impact Statement (EIS) System, thatproposed activities near the salt farms do not adversely affect the latter. The DENR shall also monitor theSECTION 8. The Bureau of Customs of the Department of Finance (DOF) shall assist the DOH inconsignees and quantity of shipment. It shall likewise inform the DOH on the quality and quantity of importationSECTION 9. Any assistance to salt manufacturers/producers/traders/importers shall take into favorablehealth, labor and employment, environment and ecology.ADVISORY BOARDSECTION 1. Creation of the Salt Iodization Advisory Board Ð The Salt Iodization Advisory Board (SIAB)Social Welfare and Development; Education, Culture and Sports; Science and Technology; the Interior and LocalGovernment; Labor and Employment; Trade and Industry; and Budget and Management; the National Economicmedical profession and the salt manufacturers, as mandated by Section 8 of this Act. The Chairman of the NNCGoverning Board shall chair the SIAB. The chairman shall convene the SIAB within one (1) month upon the IODINE DEFICIENCY DISORDERS ROLE OF AGENCIES CONCERNED IN THE SALT IODIZATION PROGRAMSECTION 1. The DOH shall lead in the implementation of this Act. Specifically, it shall:a)Spearhead a public information drive in cooperation and coordination with the LGUs and other agenciesProvincial Science Centres-Department of Science and Technology (DOST), private sector and students. Allb)Provide training on salt iodization technology and quality assurance and control through its NutritionalService (NS) in coordination with the DOST and the Technology and Livelihood Resource Centre (TLRC);c)Set and enforce standards for food-grade iodized salt and monitor compliance thereof by the food-grade saltmanufacturers through its BFAD.SECTION 2. The LGUs shall support the development and sustainability of the salt industry through:a)The formulation of ordinances and information campaigns promoting the availability and use of iodized salt;b)Provision of budget for health and nutrition programs;c)Assistance to other governmental agencies in the implementation of the salt iodization program;d)Monitoring the quality of salt as provided by law through its respective health officers and nutritional-dietitians or, in their absence, through the sanitary inspectors; ande)Establishment and maintenance of a list of salt producers in their respective territorial jurisdiction. A list ofregistered salt producers in every province shall be submitted to the BFAD within 6 months from theeffectivity of these IRR and shall be updated annually. The list shall reflect the following information per1)Name and address of company and/or owner2)Location of salt production site (sitio/barangay)3)Annual production capacity (in metric tons)4)Types of salt produced:i) food-grade (coarse or fine) -iodized salt -non-iodized saltii) industrial saltf) Distribution channels, such as:-direct sale to consumers within the province-traders within the province-traders from other provinces/regions-food manufacturers within the province-food manufacturers outside the province/regionSECTION 3. The Department of Trade and Industry (DTI) shall assist and support local salt producers/and financial assistance for the procurement of salt iodization machines, packaging equipment and technology,and fortificants; and by ensuring the systematic distribution of the iodized salt in the market. Specifically, it shall:a)Regulate an monitor the trading of iodized salt in accordance with R.A. 7581 otherwise known as the Priceb)Provide incentives to the salt industry by including salt iodization as a priority investment program of the IODINE DEFICIENCY DISORDERS d)Monitoring of salt ready for distribution: each lot shall be sampled to ensure conformity to prescribede)Packaging and labeling inspection shall be routinely conducted to ensure the integrity of the package andf)Record keeping: daily control charts and weekly summaries of activities and corrective actions taken shallbe maintained for a period of at least 12 months from date of manufacture. Manufacturers of iodized saltSECTION 4. Iodized salt shall be distributed and sold according to the principle of first in, first out. Iodizedmanufacture, after which it shall be considered expired. Expired salt shall be replaced by or returned to the lastSECTION 5. The DOH shall put in place a system to monitor the quality of iodized salt in collaborationwith the LGUs and the Department of the Interior and Local Government (DILG). It shall also seek the assistanceSECTION 6. Until such time when all food-grade salt shall be iodized in accordance with R.A. 8172, saltsalt from non-iodized salt in storage and during display at retail. They shall make sure that salt buyers orSECTION 7. Within one (1) year from the effectivity of the Act, all food manufacturers and processors shallutilize iodized salt in their products expect when the use of iodized salt will have an adverse effect on a specifiedproduct. In such cases, the food manufacturers/processors shall present appropriate evidence to the BFAD whichshall serve as basis for exemption from compliance with Section 5(e) of this Act. The BFAD shall submit to theannually.REGISTRTION OF IODIZED SALT MANUFACTURERS AND SALT IMPORTERS/DISTRIBUTORSSECTION 1. All iodized salt manufacturers and salt importers/distributors shall register with the BFADaccording to the following schedule: The large and medium manufacturers shall register within one (1) year fromthe effectivity of this Act; small manufacturers within two (2) years, and subsistence manufacturers within five (5)years. After the effectivity of these IRR, new salt producers/manufacturers shall register before operation.SECTION 2. The BFAD shall issue a License to Operate (LTO) to iodized salt manufacturers and saltand 3. Those engaged in manual salt iodized shall secure a Certificate of Training from the DOH before they canbe provided with a LTO. If an importer is already holding a valid LTO as importer, he/she need not apply foranother license; however, the importer must comply with the technical requirements and their products shall beSECTION 3. The BFAD may delegate to the LGUs its authority to issue LTOs in cities and municipalitiesother than those in the National Capital Region (NCR) and in areas where the seat or office of the DOH-RegionalField Offices (RFOs) is located, through a memorandum of agreement between the BFAD and the LGU, or theBFAD and the RFO, with the suggested terms and conditions contained in Annex 4 hereof. Such agreements shallSECTION 4. All distributors/traders of locally produced iodized salt, whether or not engaged in repacking IODINE DEFICIENCY DISORDERS 3)Small salt producer/manufacturer Ð one who produces, imports, trades in, or distributes saltyear.4)Subsistence producer/manufacturer Ð one who produces, trades in or distributes salt not exceeding twometric tons (2MT) of salt per year. Ð refers to the scientifically accepted technique that is perceived to bring about the best andMicronutrient malnutrition Ð refers to a disorder resulting from deficiencies in vitamin A, iron,iodine and other micronutrients which the body needs in minute quantities every day. Ð the process or acquiring a business/enterprise license/permit to manufacture, produce,trade or import iodized salt with the Bureau of Food and Drugs (BFAD) or appropriate LGU. Ð the provisions of all applicable laws, regulations, executive orders, andother enactmentÕs related to food quality and safety, purity, nutritional composition, and otheraspects of food regulations and control. In applying or interpreting the regulatory requirements, Ð refers to the business sector engaged in the production, distribution, trading, retailing Ð the addition of iodine to salt intended for human or animal consumption inprescribed by the BFAD of the DOH. Ð composed of the National Nutrition Council (NNC)Trading Ð refers to the bullying and selling of food-grade salt by wholesale or retail.STANDARDS and REQUIREMENTSSECTION 1. Iodized salt to be sold/distributed in the Philippines, whether locally produced or imported, shallconform with the standards formulated by the BFAD or DOH which is in Annex 1 of these implementing rules andregulations. Such standards shall be periodically reviewed and updated by the BFAD in consultation with theSECTION 2. Failure to comply with the quality specifications and labeling requirements prescribed in theSECTION 3. To ensure the quality of iodized salt prior to distribution, all manufacturers of iodized salt shallconduct routine quality assurance activities. Such activities shall include, but shall not be limited to the following:a)Iodine levels testing: at regular intervals on a daily basis, samples of iodized salt shall be collected from theb)Equipment inspection: at least twice daily to ensure its proper operation.c)Mixing process: shall be monitored regularly to ensure consistent mixing and homogeneity of iodine contentin the batch being processed. IODINE DEFICIENCY DISORDERS c) All food manufacturers/processors using salt in their manufacturing processes,d) All local government units (LGUs),f) All non governmental agencies and related professional organizations; andg) All government and private hospitals and other institutions.INTERPRETATIONSSECTION 1. These Rules and Regulations shall be construed in a manner that can achieve the objectivesof R.A. 8172 namely: a) to contribute to the elimination of micronutrient malnutrition, particularly iodinedeficiency disorders; b) to require salt producers/manufacturers to iodize the salt they manufacture, produce,distribute, trade and/or import; c) for the government agencies to undertake their roles and responsibilities incarrying out the provisions of this Act; d) for the food processing and the food service industries to use onlyiodized salt; c) to provide mechanisms and incentives for the salt industry; and f) to ensure the sustainability Ð means the exchange, transmittal, conveyance, consignment, supply, delivery, trade, sale, Ð refers to an establishment which distributes, sells or imports salt for distribution to retailers. Ð in relation to the process of salt iodization, the term shall refer to potassium iodate or othersuitable fortificant as recommended by DOH, taking into consideration the circumstances of quality,effectiveness, stability, availability and new discoveries that can bring salt iodization in the most effectiveand economic manner. Ð the addition of nutrients to processed foods at levels above the natural state. Ð refers to salt for human and animal consumption as distinguished from industrial salt.Food manufacturers/processors Ð refer to the business/enterprise of manufacturing or processing food Ð refer to hotels, restaurants, carinderias, catering firms, hospitals and other Ð refers to salt used in the treatment, processing, and/or manufacture of non-food commercial Ð a broad spectrum of manifestations resulting from lack of iodine in the dietwhich leads to the reduction of intellectual and physical capacity affecting everyone who is iodine deficientManufacturer Ð one who produces, imports, trades in and distributes salt and is categorized as follows:1)Large producer/manufacturer Ð one who produces, imports, trades and /or distributes salt exceedingtwo thousand metric tons (2,000 MT) per year.2)Medium producer/manufacturer Ð one who produces, imports, trades in, distributes salt ranging frommore than three hundred metric tons (300 MT) to two thousand metric tons (2,000 MT) per year. IODINE DEFICIENCY DISORDERS programs and activities. It shall coordinate the efforts of all agencies concerned and monitor the implementationof the provisions of this Act. It shall also submit an annual report to the Congress of the Philippines on theprogress of the salt iodization program and offer recommendations for its improvement. - as the Food, Drugs and Cosmetics Act, As Amended: Provided, That any person, whether natural or juridical,who violates any of the provisions of this Act or any of the rules and regulations promulgated for its effectiveProvided, however, That if the violation is committed by any officer,director or member of a business and a juridical entity acting beyond the scope of his authority, such officer,Provided, further, That suchviolator shall suffer a revocation of its business permit and/or a ban of its product from the market: Provided,, That the BFAD, in coordination with the LGUs concerned, shall be authorized to impose and collect thefines from the violators, and such collections shall accrue to the BFAD for its use in the implementation of thischarged to the appropriations of the agencies concerned as may be appropriated, under the current GeneralAppropriations Act. Thereafter, such amount as may be necessary for its implementation shall be includedSEC. 11. shall formulate the necessary rules and regulations for the effective implementation of this Act within sixty (60)SEC. 12. shall not be affected by such declaration and shall remain valid an enforceable.SEC. 13. Effectivity Clause - This Act shall take effect fifteen (15) days after its publication in theOfficial Gazette or in two (2) national newspapers of general circulation, whichever is earlier.This Act, which is a consolidation of Senate Bill No.112 and house Bill No.45 was finally passed by theSenate and the House of Representatives on November 16, 1995 and November 5, 1995, respectively.IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT No. 8172AN ACT PROMOTING SALT IODIZATION NATIONWIDE AND FOR RELATED PURPOSESapproved by the President on 20 December 1995 and which took effect on 20 January 1996, mandating theSection 11 of said Act mandating the DOH to formulate the Implementing Rules and Regulations (IRR) incooperation with the other government agencies involved in the implementation of the law, the following Rulesand Regulations are hereby adopted to implement effectively the provisions of R.A. No. 8172.SECTION 1. These Rules and Regulations shall apply to:a) All producers/manufacturers/importers/traders of salt for human or animal consumption,b) All restaurants and other food establishments where food is being served hot or sold, IODINE DEFICIENCY DISORDERS b)Iodized salt that conforms to the standards set by the BFAD to meet national and nutritional needs shallProvided, That the implementation of this Act shall be enforced over astaggered period of one (1) year for large and medium producers/manufacturers; two (2) years for smallc)All food outlets, restaurants, and stores are hereby required to make available to customers only iodized saltin their establishment upon effectivity of this Act. These establishments shall be monitored with the help ofthe LGUs through its health officers and nutritionist-dietitians, or in their absence, the sanitary inspectors tod)In areas endemic to iodine deficiency disorders, iodized salt shall be made available. Local governmentofficials at the provincial and municipal levels shall provide mechanisms to ensure enforcement of thise)All food manufacturers/processors using food-grade salt are also required to use iodized salt in theits effectivity: Provided, That the use of iodized salt shall not prejudice the quality and safety of their foodProvided, however, That the burden of proof and testing for any prejudicial effects due to iodizedsalt fortification lies n the said food manufacturers/processor.f)Salt producers/manufacturers shall register with the BFAD, which shall maintain an updated registry of saltg)All food-grade salt shall be labeled in a manner that is true and accurate, not likely to mislead purchasersand in accordance with the requirements prescribed by the BFAD.h)For a period of three (3) years from the effectivity of this Act, the DOH shall provide free iodized salt to Ð The following agencies and institutions shall support the salta)the DTI is hereby required to assist and support local salt producers/manufacturers in upgrading theirb)the Cooperative Development Authority (CDA) shall assist the formation of cooperatives of local saltc)the DOST, in collaboration with the TLRC, shall develop and implement comprehensive programs for thed)the Department of Environment and Natural Resources (DENR) and other appropriate government agencies - disseminated and promoted through organized, systematic and nationwide information campaign which shallPhilippine Information Agency (PIA), provincial science centers, private sector, and students.The implementing agency, in coordination with the PIA, shall seek the cooperation of the media sectorto assist in public information dissemination. Salt iodization and its benefits shall also be included and given IODINE DEFICIENCY DISORDERS e)require the Department of Trade and Industry (DTI) to regulate and monitor trading of iodized salt;f)direct the Department of Science and Technology (DOST), in collaboration with the Technology andg)authorize the National Nutrition Council (NNC), the policy-making and coordinating body on nutrition,h)provide mechanisms and incentives for the local salt industry in the production, marketing, and distributioni)ensure the sustainability of the salt iodization program.Definition of Terms Ð For purposes of this Act, the following terms shall mean:Micronutrient malnutrition Ð a disorder resulting from deficiencies in vitamin A, iron, iodine and othermicronutrients which the body needs in minute quantities everyday. Ð a broad spectrum of deficiencies resulting from lack of iodine in the dietwhich leads to the reduction of intellectual and physical capacity affecting everyone who is iodine-deficientand may manifest as goiter, mental retardation, physical and mental defects, and cretinism. Ð the addition of nutrients to processed foods at levels above the natural state. Ð the addition of iodine to salt intended for human or animal consumption in accordanceBFAD. Ð salt for human and animal consumption as distinguished from industrial salt.Regulatory requirements Ð the provisions of all applicable laws regulations, executive orders, and otherenactmentÕs related to food quality and safety, purity, nutritional composition, and other aspects of food Ð salt used in the treatment, processing, and/or manufacture of non-food commercialManufacturer Ðone who produces, imports, trades in and distributes salt.Subsistence producer/manufacturer Ð one who produces, trades in or distributes salt not exceeding twometric tones (2m.t.) per year.Small producer/manufacturer Ð one who produces, imports, trades in or distributes salt ranging frommore than two metric tones (2m.t.) to three hundred metric tons (300 m.t.)per year.Medium producer/manufacturer Ðone who produces, imports, trades in or distributes salt ranging frommore than three hundred metric tons (300 m.t.) to two thousand metric tons (2,000 m.t.) per year.Large producer/manufacturer Ð one who produces, imports, trades in or distributes salt exceedingtwo thousand metric tones (2,000 m.t.) per year.a)This Act shall apply to the entire salt industry, including salt producers/manufacturers, importers, traders and IODINE DEFICIENCY DISORDERS ASIN Law, The PhilippinesAn Act Promoting Salt Iodization Nationwide and for Related Purposes (ASIN LAW)Congress of the PhilippinesMetro ManilaBegun and Held in Metro Manila, on Monday the twenty-fourth day of July,,AN ACT PROMOTING SALT IODIZATION NATIONWIDEAND FOR RELATED PURPOSESBe it enacted by the Senate and House of Representativesof the Philippines in Congress assembled:Title. Ð This Act shall be known as ÒAn Act for Salt Iodization Nationwide (ASIN)Ó.Declaration of Policy. Ð It is hereby declared the policy of the State to protect and producethe health of the people, to maintain an effective food regulatory system, and to provide the entire populationespecially women and children with proper nutrition. For this purpose, the State shall promote the nutritional Ð The purposes of this Act are to:a)Contribute to the elimination of micronutrient malnutrition in the country, particularly iodine deficiencydisorders, through the cost effective preventive measure of salt iodization;b)require all producers/manufacturers of food-grade salt to iodize the salt that they produce, manufacture,c)require the Department of Health (DOH) to undertake the salt iodization program and for its Bureau of Foodand Drugs (BFAD), to set and enforce standards for food-grade iodized salt and to monitor complianced)require the local government units (LGUs), through their health officers and nutritionist-dieticians, or in their IODINE DEFICIENCY DISORDERS 0-49 6 50-9927100-14935150-19913200-249 7250-299 5300-349 2350-399 1400-449 0450-499 1500-549 1550-599 0 0-49 Frequency 011125762735 IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildreng/l) Value Rank Percent Descriptive Statistics133927028.80% 80907126.80% 87907126.80% 96897325.70%120887424.70%146877522.60%160877522.60%124867721.60% 90837820.60% 10827918.50% 55827918.50%108808116.40%480808116.40% 80758315.40%122748414.40%198668512.30%200668512.30% 87658711.30%200648810.30%1886389 8.20% 546389 8.20%2735591 7.20%1205492 6.10%1404993 5.10%1104294 4.10% 423595 3.00% 953296 2.00%1172697 1.00%2951098 .00% IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildreng/l) Value Rank2641443465.90%1421423563.90%1741423563.90%1211413762.80%3951403860.80%3201403860.80%2401384057.70%1401384057.70% 661384057.70%1461354356.70%1151334455.60% 821324554.60% 821284653.60%5351244752.50% 741224850.50% 351224850.50% 831215049.40%1041205146.30% 641205146.30%2081205146.30% 491185445.30% 891175544.30%1091155642.20%1061155642.20% 321145840.20%1281145840.20%2321116039.10% 881106138.10%1151096237.10%1441086336.00% 861066435.00%1501046534.00%224 966632.90% 92 956730.90%180 956730.90%193 946929.80% IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildren UI(g/l) Value Rank Percent141535 1 100.00%138480 298.90%138395 397.90%Standard error154340 496.90%162320 595.80%Mode138 26295 694.80%Standard deviation87.88117 63273 792.70%Sample variance 111273 792.70%120264 991.70% 652611090.70%Range5251902401189.60%Minimum101422321287.60%Maximum5351382321287.60%Sum13989 952241486.50%Count982732081585.50%Confidence1322001683.50% level (95.0%)1642001683.50% 661981882.40%1581931980.40%1141931980.40%1181902179.30%2321882278.30%1451802377.30% 941742476.20% 901642575.20%1221622674.20%1141602773.10%3401582872.10%1931542971.10%1351503070.10%2611463168.00% 751463168.00% 631453367.00% IODINE DEFICIENCY DISORDERS 6.The 20 and 80 percentiles may are readily observed, or[=PERCENTILE (range of cells,0.2)]. The 20 percentile7.The ÒDescriptive StatisticsÓ function of Data Analysis in Exceldialogue box. Note that the mean is much higher than the median,indicating that the distribution is heavily skewed to the right.8.In addition, the data can be shown as a histogram using the. Convenientg/l, and so on). Appropriatefunctions. The histogram is shown in Figure 4. A fully detailedTable 13: Summary of resultsNumber 98 percentile 82.4 percentile191.8 g/l 33.7% g/l 5.1% g/l 1.0% 0; 500 g/l 1.0%These results indicate that there is no iodine deficiency, and that salt iodizationoveriodization. No changes are needed on the basis of these results, IODINE DEFICIENCY DISORDERS column of Table 14. The data have been entered into a spreadsheet on apersonal computer for ease of calculation. However, with small numbers such1.Before proceeding, carefully check the data entered againstthe original. Ensure that the same number of data points (2.Next, sort the data from highest to lowest, or vice-versa.The spreadsheet will do this automatically. (In Microsoft use the Data Analysis function on the Tools menu, and selectÒRank and PercentileÓ.) The sorted data are shown underÒValueÓ in Table 14, starting with the highest value. The nextcolumns show the rank and percentile for each data point.The median is the middle value of the ranked data. In other words, value98 data points, so the median is the value of (98+1) divideddata point. Accordingly, use the middle point and 50 values: 122 and 121 g/l, respectively.4.Next, calculate the number of values below 100, 50, and 20 respectively. The ranking will allow this to be done very easily.5.Check if any values are above 500 g/l. There is one (1.0%). Summarizing urinary iodine data: IODINE DEFICIENCY DISORDERS Accordingly, another approach may be more appropriate.using the PPS method. Develop a listing of the districts, their populations,and cumulative populations similar to the PPS selection described earlier.Next, determine the number of schools to survey, based on the cumulativedistrict using a random number table. For example, if a district has 200 schools,number them from 1 to 200. Then, randomly select a number from 1 to 200using the table. If two schools are to be selected, then randomly select twonumbers. Finally, and while not technically correct, it would be acceptable toPPS methodology.In situations where males and females attend separate schools, when a schoolattend separate schools. Thirty schools are to be selected, and twenty pupilssampled in each. When an all-male school is visited, information should becollected on ten male pupils. Then, the nearest female school is visited, 2nd ed. UNICEF, PAMM, 2000. IODINE DEFICIENCY DISORDERS Table 12: Selection of schools1Utural26Ban Vinai2Mina27PuratnaY3BolamaY28Kegalni4Taluma29Hamali-Ura5War-Yali30Kameni6Galey31Kiroya7Tarum32Yanwela8Hamtato33BagviY9NayjaffY34Atota10Nuviya35Kogouva11Cattical36Ahekpa12Paralai37Yondot13Egala-Kuru38Nozop14Uwarnapol39MapazkoY15HilandiaY40Lotohah16Assosa41Voattigan17Dimma42Plitok18Aisha43Dopoltan19Nam Yao44Cococopa20Mai Jarim45FamegziY21PuaY46Jigpelay22Gambela47Mewoah23Fugnido48Odigla24Degeh Bur49Sanbati25Mezan50AndidwaMethod 3 - an extremely large number of schoolsIn very large populations, it may not be possible or efficient to select schoolsusing either the PPS or the systematic selection method. For example,much time and effort to select schools using either of these methods. IODINE DEFICIENCY DISORDERS For illustrative purposes, Table 12 lists fifty schools. The following methodStep one:There are fifty schools, therefore Step two:The number of schools to sample is eight;Step three:The sampling interval is 50 / 8 = 6.25; round down tothe nearest whole integer, which is 6; therefore, Step four:Using a random number table, select a numberfrom 1 to (and including) 6. In this example,Accordingly, the first school to be selected wouldStep five:Select every sixth school thereafter; in this example,the number needed. In the above example, for instance, had the randomselected rather than eight. This is because the value for was rounded downIn this situation, to remove one school so that only eight are selected,again go to the random number table to pick a number. The school thatcorresponds to that random number is removed from the survey.To analyse properly the data collected using systematic sampling, additionalinformation needed would include the number of eligible pupils in each school.Note that usually thirty clusters are selected; the eight indicated in Table 12have been selected in this example for illustrative purposes only. IODINE DEFICIENCY DISORDERS earlier in this chapter, should be used. First, generate a list of schools similarto that shown in Table 11. Second, determine the cumulative enrolment.Finally, select schools using the same PPS method as described for selectingcommunities (see Table 10).Table 11: Selection of schools using the PPS methodSchoolEnrolmentCumulative enrolmentUtural 600 600Mina 700 1,300Bolama 350 1,650), usually thirty.and include that school in the survey. IODINE DEFICIENCY DISORDERS age for the survey. Because the age range for the survey is 6-12 years, theIdeally, the Ministry of Education will have such a listing.is needed. If subnational estimates are required, then a listing of the schoolsfor each subnational area is needed. If enrolment information for each schoolis available, the PPS method should be used for selection. If enrolmentHowever, if enrolment information cannot be obtained easily there may beno alternative. If there is an extremely large number of schools in an area, IODINE DEFICIENCY DISORDERS Table 10: Selection of communities in El SabaUtural600 600Ban Vinai40010,88013Mina7001,3001Puratna22011,100Bolama3501,6502Kegalni14011,240Taluma6802,3803Hamali-Ura 8011,320War-Yali4302,810Kameni41011,73014Galey2203,030Kiroya28012,010Tarum 403,070Yanwela33012,340Hamtato1503,2204Bagvi44012,78015Nayjaff 903,310Atota32013,100Nuviya3003,610Kogouva12013,22016Cattical4304,0405Ahekpa 6013,280Paralai1504,190Yondot32013,600Egala-Kuru3804,570Nozop 1,78015,38017Uwarnapol3104,8806Mapazko39015,77019Hilandia 2,0006,88078Lotohah 1,50017,27020Assosa7507,6309Voattigan96018,23021Dimma2507,880Plitok42018,650Aisha4208,30010Dopoltan27018,900Nam Yao1808,480Cococopa 3,50022,40023Mai Jarim3008,780Famegzi40022,820Pua1008,880Jigpelay21022,840Gambela7109,59011Mewoah 5022,890Fugnido1909,88012Odigla35023,24028Degeh Bur150 10,030Sanbati 1,44024,68029450 10,480Andidwa26024,94030 ClusterName IODINE DEFICIENCY DISORDERS In Table 10 on the opposite page, the first column contains the names of thecommunities, the second column the population of each community, and thethird column the cumulative population. A fourth column is used forContinue to assign clusters by adding 831 cumulatively.If two clusters are selected in one community, when the survey is performedpopulation size and perform a survey in each section. Similarly, if three ormore clusters are in a community, the community would be divided into three IODINE DEFICIENCY DISORDERS be representative of the area to be surveyed. Methods used for performingcommunities in the area of interest. This information is usually available fromthe central statistical office within the Ministry that performs the census forthe country.From the census data, select the data for the area chosen for the survey.Make a list with four columns (see Table 10). The first column lists the nameof each community. The second column contains the total population of eachcommunity. The third column contains the cumulative population - this isobtained by adding the population of each community to the combinedpopulation of all of the communities preceding it on the list. The list can be inpopulation size by the number of clusters to be surveyed. A random numberusing random number tables, and the sampling interval is added cumulatively. person, the (x+2n)The 30 clusters should be plotted on a map. Next, a logical sequence for theIn the fictitious area of El Saba, there are fifty communities (Table 10). Methodology for selection of survey sites by PPS sampling IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS 2. Since the digestion procedure has no specific end-point, it is essential to run blanks3. The exact temperature, heating time, and cooling time may vary. However,within each assay, the interval between the time of addition of ceric4. With the longer ceric ammonium sulfate incubation and with 15 secondinterval additions of CAS, up to 120 tubes can be read in a single assay.5. The volumes and proportions of samples and reagents can be variedto achieve different concentrations or a different curve shape, if conditionswarrant. If different tube sizes are used, corresponding sized holes in the6. If necessary, this method could probably be applied without a heating block,using a water, oil, or sand bath, but this is not recommended. It is essential7. Test tubes can be reused if they are carefully washed to eliminate any8. Various steps of this procedure are suitable for automation. For example,the colorimetric readings can be done in microtiter plates with a scanner, andthe standard curves plotted and read on a simple desk computer.ICCIDD, UNICEF, WHO. Dunn JT et al. The Netherlands, ICCIDD, 1993. IODINE DEFICIENCY DISORDERS Dissolve 48 g ceric ammonium sulfate . (The 3.5 is made by slowly adding 97 ml N) H to about 800 ml deionized water volume of 1 litre). Store in a dark bottle away from light at room temperature. Dissolve 0.168 mg in deionized water to a final volume of 100 ml (1.68 mg KIO contains is preferred over KI because it is more stable,g/ml. Store in a dark bottle. The solution isstable for months. Useful standards are 20, 50, 100, 150, 200, and 300 2. Pipette 250 l of each urine sample into a 13 x 100 mm test tube. Pipettel. Duplicate iodine standards and a set of internal urinestandards should be included in each assay.3. Add 1 ml 1.0 M ammonium persulfate to each tube.4. Heat all tubes for 60 minutes at 1005. Cool tubes to room temperature.7. Add 300 at 15-30 second intervals between successive tubes. A stopwatch should beused for this. With practice, a 15 second interval is convenient.8. Allow to sit at room temperature. Exactly 30 minutes after addition of ceric IODINE DEFICIENCY DISORDERS Urine is digested with ammonium persulfate. Iodide is the catalyst in theHeating block (vented fume hood not necessary), colorimeter, thermometer,1. Ammonium persulfate (analytical grade)7. KIO1.0 M Ammonium persulfate: Dissolve 114.1 g H in HO. Store away from light. Stable for at least one month. Slowly add 139 ml concentrated (36 N) H to about 700 ml. When cool, adjust with In a 2000 ml Erlenmeyer flask, place 20 g As . Add water to about 1 litre,filter, store in a dark bottle away from light at room temperature. The solution Method for measuring urinary iodineusing ammonium persulfate (Method A) 3 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS during data entry. Portable ultrasound equipment is relatively rugged,but requires electricity. However, it can be operated from a car battery with theaid of a transformer. Trained operators can perform up to 100 or moreexaminations per day. x H x 71.84 x 10 IODINE DEFICIENCY DISORDERS Reagent preparationfor this method should be boiled distilled water, whichrequires provision of a distillation unit. As a simpler alternative, regular tap Dissolve 1.24 g Na1000 ml water. Store in a cool, dark place. This volume is sufficient for100-200 samples, depending on their iodine content. The solution is stablefor at least one month, if stored properly. Slowly add 6 ml concentrated H to 90 mlwater. Make to 100 ml with water. This volume is sufficient for 100 samples.The solution is stable indefinitely. Always add acid to water, to avoid excess heat formation and spitting of acid. Stir solution while adding Dissolve 100 g KI in 1000 ml water. Store in acool, dark place. This volume is sufficient for 200 samples. Properly stored Dissolve reagent-grade sodium chloride (NaCl)in 100 ml double-distilled water. While stirring, add NaCl until no moredissolves. Heat the contents of the beaker until excess salt dissolves.While cooling, the NaCl crystals will form on the sides of the beaker. When itis completely cooled, decant the supernatant into a clean bottle. This solutionis stable for six to twelve months. Dissolve 1 g chemical starch in 10 mldouble-distilled water. Continue to boil until it completely dissolves. Add thesaturated NaCl solution to make 100 ml starch solution. This volume issufficient for testing 20 to 45 samples. Prepare fresh starch solution everyday, since starch solution cannot be stored.UNICEF, PAMM, MI, ICCIDD, WHO. Sullivan KM et al., eds. Atlanta, PAMM, MI, ICCIDD, 1995.De Maeyer EM, Lowenstein FW, Thilly CH. The control of endemic goiter.Geneva, World Health Organization, 1979. IODINE DEFICIENCY DISORDERS free iodineof free iodine liberated from the salt. Starch is added aswith free iodine to produce a blue colour. When addedamount of free iodine is left) the loss of blue colour, or (from (from (from salt) KI) H Sodium Iodine Sodium Sodium Titrimetric method fordetermining salt iodate content IODINE DEFICIENCY DISORDERS Assessment of Iodine Deficiency Disorders and Monitoring their Elimination A guide for programme managers Second edition IODINE DEFICIENCY DISORDERS Assessment of Iodine Deficiency Disorders and Monitoring their Elimination A guide for programme managers Second edition IODINE DEFICIENCY DISORDERS © WORLD HEALTH ORGANIZATION, 2001and all rights are reserved by the Organization. The document may, however, be IODINE DEFICIENCY DISORDERS Executive summary While a variety of methods exists for the correction of iodine deficiency,has been eliminated in a sustainable way.responsibility of the producer, with verification by an external body such asthe national food standards authority. i iii IODINE DEFICIENCY DISORDERS role because it reflects chronic rather than immediate iodine deficiency,but remains useful in the baseline assessment of IDD severity. Thyroid n median urinary iodine levels in the target population areat least 100 mg/l and no more than 20% of values arebelow 50 mg/l; n at least 90% of households are using salt with an iodinecontent of 15 parts per million (ppm) or more; and n there is evidence of sustainability, as judged by the attainment iv IODINE DEFICIENCY DISORDERS Contents Chapter Title PageiExecutive summary iiiiiTable of contents viiiList of tablesivList of figures ixvAbbreviations and acronyms xviAcknowledgements xiviiPrefacexii 1Introduction 11.1About this manual 11.2Definitions 31.3Monitoring and evaluatingIDD control programmes 41.4Indicators describedin this manual 5 2IDD and their control, andglobal progress in their elimination 72.1The Iodine Deficiency Disorders 72.2Correction of iodine deficiency102.3Universal salt iodization2.4Sustainability122.5Global progress inthe elimination of IDD172.6Challenges for the future:consolidating the achievement19 ii v IODINE DEFICIENCY DISORDERSContents Chapter Title Page 3Indicators of the salt iodization process213.1Factors that determine salt iodine content213.2Determining salt iodine levels243.3Monitoring systems25 4Indicators of impact314.1Overview314.2Urinary iodine314.3Thyroid size374.4Blood constituents41 5Survey methods475.1Overview475.2Salt monitoring475.3Iodine status assessment495.4Combined micronutrientdeficiency surveys525.5IDD surveys in areaswith no prevalence data535.6Sentinel surveillance535.7Measuring progress towards achievinglong-term micronutrient goals545.8Target groups for surveillance545.9Interpreting and presenting results55 6Indicators of the sustainableelimination of IDD59 63 vi IODINE DEFICIENCY DISORDERSContents Annex Title Page 1Titrimetric method for determiningsalt iodate content69 2Method for determining thyroid sizeby ultrasonography71 3Method for measuring urinary iodineusing ammonium persulfate (Method A)73 4Methodology for selectionof survey sites by PPS sampling77 5Summarizing urinary iodine data:a worked example85 6Legislation on iodized salt:ASIN Law, The Philippines91 7List of participants: vii IODINE DEFICIENCY DISORDERS Tables Number Title Page 1The spectrum of the Iodine Deficiency Disorders (IDD) 8 2Current magnitude of IDD by goitreby WHO Region (1999)17 3Current status of salt iodization coverageby WHO Region (1999)18 4Current status of monitoring activities andlaboratory facilities in IDD-affected countries (1999)19 5Epidemiological criteria for assessing iodine nutritionin school-aged children36 6Simplified classification of goitre by palpation39 7Epidemiological criteria for assessing the severityin school-aged children40 8Circumstances when school-basedPPS cluster surveys may not be appropriate51 9Summary of criteria for monitoring progressas a public health problem61 iii viii Tables Title 10Selection of communities in El Sabausing the PPS method 79 11Selection of schoolsusing the PPS method 81 12Selection of schools usingthe systematic selection method 83 13Summary of results 86 14Urinary iodine data in Cameroon schoolchildrenfollowing salt iodization 87 Figures NumberTitle Page 1Social process modelfora national IDD control programme 14 2Components of a routine monitoring system for USI 29 3Programme monitoring and feedback loops 30 4Frequency table and histogram to show distributionof urinary iodine values after iodization in Cameroon 90 iv ix IODINE DEFICIENCY DISORDERS PAMMTriiodothyronineTotal goitre rateUnited Nations ChildrenÕs Fund Abbreviations v x IODINE DEFICIENCY DISORDERS Acknowledgements vi xi Charles Todd, who has been closely associated with the development of IODINE DEFICIENCY DISORDERS Preface viixii For these reasons, revision of the document was considered necessary.programmes. To be fully effective in correcting iodine deficiency, however,governments and the salt industry, requiring close collaboration between IODINE DEFICIENCY DISORDERS International Council for Controlof Iodine Deficiency DisordersWorld Health United Nations xiii However, the usefulness of urinary iodine to readjust a programme is moreeffective if salt is adequately iodized: ideally, it is the primary role of theFor each impact indicator, this manual provides information on biological IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS11 1Universal salt iodization (USI) is defined as when all salt for human and animalconsumption is iodized to the internationally agreed recommended levels. Introduction1.1About this manual Iodine deficiency, through its effects on the developing brain, has condemnedPeople living in areas affected by severe IDD may have an intelligence quotientimmediate effect on child learning capacity, womenÕs health, the quality of lifeof communities, and economic productivity.Recognizing the importance of preventing IDD, the World Health Assembly 11 IODINE DEFICIENCY DISORDERS Techniques are then needed to measure these indicators (Finally, the results have to be presented in a digestible format, comparableSpecifically, the objectives of this manual are to describe: n the indicators used in assessing the baseline severity of IDD,and in monitoring and evaluating salt iodization and its impacton the target population; n how to use and apply these indicators in practice; n how to assess whether iodine deficiency has been successfullyeliminated; and n Target audience 2 IODINE DEFICIENCY DISORDERS the importance of the process indicators. To continue the battle against IDD 1.2Definitions refer to all of the ill-effects of iodine deficiencyobjectively as possible the relevance, effectiveness, and impact of activities 3 IODINE DEFICIENCY DISORDERS 1.3 Monitoring and evaluating IDD control programmes if necessary. In addition, periodic evaluation of health programmes is necessaryrequire an effective system for monitoring and evaluation. The challenge iscosts to a minimum. To this end, it is essential to formulate clearly the questionsvery different. Important questions that will need to be answered include: n to the countryÕs requirements? n Is the salt adequately iodized? n Is adequately iodized salt reaching the target population? n What impact is salt iodization having on the iodine status n Have IDD been eliminated as a public health problem?In some countries there is still inadequate information on IDD, and programmeshave not yet been implemented. Here the questions may be: n Is there a significant IDD problem? n What is the prevalence of IDD in a given population? n Answering these questions requires different approaches to gathering data.survey. 4 IODINE DEFICIENCY DISORDERS 1.4Indicators described in this manual This manual describes the various indicators which are used in monitoringand evaluating IDD control programmes. The indicators are divided into three n Indicators to monitor and evaluate the salt iodization process (process indicators) These indicators involve salt iodine content at the production site, n Indicators to assess baseline IDD status and to monitorand evaluate the impact of salt iodization on the targetpopulation (impact indicators) Once a salt iodization programme has been initiated, the principalgoitre prevalence lag behind changes in iodine statusand therefore cannot be relied upon to reflect accurately currentGoitre assessment, by palpation or by ultrasound, should remaina component of surveys to establish the baseline severity of IDD. n Indicators to assess whether iodine deficiency has beensuccessfully eliminated and to judge whether achievements (sustainability indicators) are regarded as evidence of sustainability. 5 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS 11 2.1The Iodine Deficiency Disorders WHO, UNICEF, and ICCIDD ( n 90 mg for preschool children (0 to 59 months); n 120 mg for schoolchildren (6 to 12 years); n 150 mg for adults (above 12 years); and n be able to synthesize sufficient amounts of thyroid hormone. The resultingharmful effects known collectively as the Iodine Deficiency Disorders (simply goitre and cretinism (see Table 1). 27 IODINE DEFICIENCY DISORDERS Table 1: The spectrum FETUS mental deficiency, deaf mutism,mental deficiency, dwarfism, hypothyroidism NEONATE Neonatal hypothyroidism CHILD &ADOLESCENT Retarded mental and physical development ADULT Goitre and its complicationsIodine-induced hyperthyroidism (IIH) ALL AGES GoitreHypothyroidismThe most critical period is from the second trimester of pregnancy to the6, 7) . optimal development of the brain. In areas of iodine deficiency, where thyroidhormone levels are low, brain development is impaired.cognitive capacity which affect the entire population. As a result, the mental 8 IODINE DEFICIENCY DISORDERS Thus, the potential of a whole community is reduced by iodine deficiency.Indeed, everybody may seem to be slow and rather sleepy. The quality of lifeis poor, and ambition blunted.domestic animals, such as the village dogs, are affected. Livestock productivityHowever, the greater availability of urinary iodine estimation and other methods n where the prevalence of goitre, as based on palpation, is normal; n in coastal areas; n in large cities; n in highly developed countries; and n where IDD have been considered to have been eliminated,either by prophylactic programmes or general dietary changes.In recognition of the much wider occurrence of IDD than previously thought,certain countries have come to regard the whole country as being at risk of 9 IODINE DEFICIENCY DISORDERS 2.2Correction of iodine deficiency the salt supply. Most humans eat salt in roughly the same amount each day.countries. At this stage, however, sustainability of this successful correction n administration of iodized oil capsules every 6-18 months (10); n direct administration of iodine solutions, such as LugolÕs iodine, n of hypothyroidism due to iodine deficiency. Such an increase in vitality is 10 IODINE DEFICIENCY DISORDERS Education about these basic facts has to be repeated, with the inevitablechanges over time in Ministries of Health and among technocrats and salt 2.3Universal salt iodization that the most effective way to achieve the virtual elimination of IDD is throughin the food industry. Adequate iodization of all salt will deliver iodine in the nDecision phase: the purposes of this phase are to enablea decision on universal salt iodization supported by industry nImplementation phase: this phase ensures infrastructurefor iodization and packaging of all human and livestock salt, nConsolidation phase: once the goal of universal iodizationis achieved, it needs to be sustained through ongoing process 11 IODINE DEFICIENCY DISORDERS n government ministries (legislation and justice, health, industry, n salt producers, salt importers and distributors, food manufacturers; n concerned civic groups; and n reaching the IDD elimination goal and sustaining it forever.system, the government, and civic society. The establishment and maintenance). This guideline, however, 2.4Sustainability poses the issue of sustainability. Indeed, sustainability is absolutely critical.IDD cannot be eradicated in one great global effort like smallpox and,hopefully, poliomyelitis. Smallpox and poliomyelitis are infectious diseases 12 IODINE DEFICIENCY DISORDERS deficiency of iodine in soil and water. IDD can therefore return at any timeiodization, or still have some distance to go, the vital message is clear. nPolitical supportnAdministrative arrangementsnAssessment and monitoring system Political supportThis refers primarily to support at governmental level, through the MinisterWithout this community awareness, politicians are unlikely either to be awareor willing to act. Political support is essential for the passage of laws orAdministrative arrangementsThe National Body responsible for the management of the IDD control 13 IODINE DEFICIENCY DISORDERS Figure 1: Social process model for a national IDD control programmeThis model shows the social process involved in a national IDDcontrol programme. The successful achievement of this process requiresAdapted from Hetzel BS, Pandav C. SOS for a billion. The conquest ofiodine deficiency disorders, 2nd ed. New Delhi, Oxford University Press, 1996. Implementation CommunicationHealthprofessionsand publicMinistry of Healthand otherPopulation at riskUrinary iodineProgrammeEmergencySalt iodineResourceCommunity Proposal supportPoliticaldecisionPlanningMonitoringAssessment National 14 IODINE DEFICIENCY DISORDERS The social process involves six components, clockwise in the hub of the wheel.1. Assessment of the situation requires baseline IDD prevalencesurveys, including measurement of urinary iodine levels andan analysis of the salt situation.2. Dissemination of findings implies communication to health professionals and the public, so that there is full understanding3. Development of a plan of action includes the establishmentof an intersectoral task force on IDD and the formulation of a4. Achieving political will requires intensive education andlobbying of politicians and other opinion leaders.5. Implementation needs the full involvement of the salt industry.systems reach all affected populations, including the neediest.salt technology, laboratory methods, and communication. Monitoring and evaluation efficient system for the collection of relevant scientific data onspecial difficulties in implementation. Experience indicates that particulartheir different professional orientations. There is need for mutual educationabout the health and development problems of IDD, and about the problemsby an educated community. This will greatly assist sustainability. 15 IODINE DEFICIENCY DISORDERS in the fetus and in the young infant when the brain is growing rapidly. Whetheriodine (at the factory, retail, and household levels) and urinary iodinemeasurements must be carried out regularly, according to the proceduresAccordingly, appropriate measures can be taken, if necessary, to ensure thenormal range of intake of iodine. All these procedures require internal and n laboratories, for measurement of salt iodine and urinary iodine, which are available at the country and regional levels with some support from international laboratories for quality control:regional reference laboratories are important for sample n Money, trained manpower, equipment, and materials are also required to 16 IODINE DEFICIENCY DISORDERS 2.5Global progress in the elimination of IDD IDD problem. A total of approximately 740 million people were affected bypopulation suffers from IDD and, in particular, from some degree of mentalcentury, the last decade has seen the greatest progress. That progress hasIn spite of this progress, however, the estimated number of the total affectedTable 2: Current magnitude of IDD by goitre WHO Region Population Population affected by goitre in millions* in millions % of the Region Africa 612 124 20%The Americas 788 39 5%South-East Asia 1477 172 12%Europe 869 130 15%Eastern Mediterranean 473 152 32%Western Pacific 1639 124 8% Total 5858 741 13% Source: WHO Global IDD Database (to be published).*Based on UN Population Division estimates, 1997. 17 IODINE DEFICIENCY DISORDERS salt industry, there has been an enormous increase in the consumption ofiodized salt. The latest data for each of WHOÕs Regions are summarized inTable 3.Table 3: Current status of salt iodization coverage WHO Region Percentage of households with access to iodized salt* Africa 63%The Americas 90%South-East Asia 70%Europe27%Eastern Mediterranean Western Pacific76% Overall 68% Source: adapted from WHO, UNICEF, ICCIDD. Progress towards elimination*Total population of each country multiplied by the percentage of householdsRegions, are summarized in Table 4. 18 IODINE DEFICIENCY DISORDERS Number ofIDD-affectedcountriesmonitoringsaltqualitymonitoringiodinestatusNumber of IDD-affected countriesWHORegionswithlaboratoryfacilities* Table 4: Current status of monitoring activities andlaboratory facilities in IDD-affected countries (1999)Africa 44292428The Americas 19191919South-East Asia 9 8 7 6Europe 32171313 Mediterranean 171410 11Western Pacific 9 8 6 7 Total 130957984Per cent 100%73%61%65% however, is very different. 2.6 Challenges for the future: consolidating It is clear that, despite the great success in many countries, there remain n Continued and strong government commitment and motivation,with appropriate annual budgetary allocations to maintain theprocess, are essential to eliminate IDD. n resources to ensure effective iodization. Producer compliance,addressed through effective advocacy and social communications. 19 IODINE DEFICIENCY DISORDERS n Monitoring systems should be in place to ensure specifiedsalt iodine content, and should be coordinated with effectiveregulation and enforcement. n or through working with a common distributor, thus reducing n In some countries, salt for animal consumption has not beenincluded in the iodization programme and is not covered bylegislation. Animal productivity is also enhanced by elimination n is as important as the provision of clean water. There is adequate knowledgeof existing technology. The achievement of the sustained elimination of IDD 20 IODINE DEFICIENCY DISORDERS 3.1Factors that determine salt iodine content they have implications for programme effectiveness, safety, and cost. n variability in the amount of iodine added during the iodizationprocess; n uneven distribution of iodine in the iodized salt within batches n the extent of loss of iodine due to salt impurities, packaging, and n loss of iodine due to food processing, and washing and cooking 1Indicators of the saltiodization process 3 than potassium iodide because of its greater stability, particularly in warm, damp, orthe ingestion of these salts below the level of Provisional Maximum Tolerable Daily 21 IODINE DEFICIENCY DISORDERS A recent laboratory study (with tropical and subtropical climates. The study showed that high humidity,range of 10-15%) by using packaging with a good moisture barrier, such aslow-density polyethylene (LDPE) bags. However, longer storage - beyond Recommendations WHO/UNICEF/ICCIDD recommend (19) that, in typical circumstances, where: n iodine lost from salt is 20% from production site to household, n another 20% is lost during cooking before consumption, and n average salt intake is 10 g per person per day,g of iodine per person per day. The iodine should be added as 22 IODINE DEFICIENCY DISORDERS However, in some instances the quality of iodized salt is poor, or the saltsalt consumption is sometimes much less than 10 g per person per day. As aiodization of salt, and factors affecting the utilization of iodized salt, should be n salt quality and the iodization process; n factors affecting iodine losses from salt, such as packaging, n with the salt industry, taking into account expected losses and local saltprogramme is having the desired effect.and facilitates comparison of its different forms. 23 IODINE DEFICIENCY DISORDERS 3.2Determining salt iodine levels indicator. The method of liberating iodine from salt differs depending on whetherlaboratory. Large- and medium-scale salt producers should carry out titrationTitration is preferred for accurate testing of salt batches produced in factoriesor upon their arrival in a country, and in cases of doubt, contestation, etc.internal and external quality control measures. However, the titration methodthroughout the country. 24 IODINE DEFICIENCY DISORDERS indication that salt actually is iodized. Accordingly, they can be used fordemonstration purposes in schools and other institutions. However, becauseThere are a large number of test kits available on the market; moreover, many However, a comprehensive review to assess these kits is still 3.3Monitoring systems inspection systems have emerged in different countries.Test kits can be obtained by directing requests to MBI, 85 GN Chetty Road, III Floor,T Nagar, Madras 600 017, India. 25 IODINE DEFICIENCY DISORDERS the Health Ministry. In other countries, the Ministry of Industry, or Mines,or Agriculture has this responsibility. In the case of importation of salt,to comply with the law.increases, special efforts need to be made to identify the non-compliantimporter, producer and distributor and systematically eliminate that problem.Salt must be iodized indefinitely, or until it is demonstrated that an adequatesystem in the country.own facility, as each has its own unique characteristics.The Ministry of Industry, the Bureau of Standards, or Codex Alimentarius are 26 IODINE DEFICIENCY DISORDERS production or packaging facility, but also the assurance that the producer closelylevels are not satisfactory, immediate corrective action should be taken andBecause production methods and factory sizes vary so widely, it is beyondcorrespond to the level allowed for under the law.own iodization facility. All salt should be distributed in polyethylene bags, 27 IODINE DEFICIENCY DISORDERS Monitoring at the household levelThere are two basic methods for obtaining household-level data: n Cross-sectional surveys; and n Community-based monitoring.Cross-sectional surveysCross-sectional surveys are conducted infrequently (see Chapter 5: Surveymethods). A household questionnaire concerning the use of iodized saltThis questionnaire was included in the UNICEF Multiple Indicator HouseholdCluster Survey (MIHCS) in 1996, and will be repeated in the next round.The results allow for visual representations of variations of coverage andprovide a basis for targeting resources and focusing interventions in areas25).Community-based monitoringOngoing household-level monitoring is used more frequently than periodic 28 IODINE DEFICIENCY DISORDERS Finally, the occurrence of parallel markets in uniodized salt has frequently been Figure 2: Components of a routine monitoring system for USI Actions StandardsChecksn Laws n Regulations n Standards n Inspections in factories n Laboratory results by titration n Licensing n Warning n Publicizing n Fining n Banning n Best manu- facturing practices n Purchasing specifications n Packaging n Labelling n Quality assurance n Titration n Producing or purchasing n labelled poly bags 29 IODINE DEFICIENCY DISORDERS ActionsNational/provincial programmes1n Measure iodized salt usage n Determine iodine content with test kits, backed by titration n Test urinary iodine n Measure overall success n Identify problem areas n Identify Ôblack marketÕ n Target n Promote iodized salt consumption n Provide and promoteuse of test kits GovernorÕs Office, District Medical Officers, midwives, teachers, volunteers, etc.which result in feedback, which aids and reinforces their activities. Similarly, n Increase awareness n Increase demand n Increase supply n Identify Ôblack marketÕ n Advocate for political action n Mobilize programme resources Feedback from actionsto programmes and monitoringActionsCommunity-level monitoring2 30 IODINE DEFICIENCY DISORDERS 4.1Overview assessing IDD prevalence. However, because of the long response time afterhas been a significant development. However, this approach requires costlyequipment and a source of electricity in the field. Moreover, there are as yetTwo other indicators are included in this discussion: thyroid stimulating hormonesensitive to iodine deficiency, difficulties in interpretation remain. Furthermore, 4.2Urinary Iodine even within a given day. However, this variation tends to even out among 431 IODINE DEFICIENCY DISORDERS adequate assessment of a populationÕs iodine nutrition, provided a sufficientnumber of specimens is collected. Twenty-four hour samples are difficult toobtain and are not necessary.unnecessary. Indeed, urinary iodine/creatinine ratios are unreliable,low.for months or more, preferably in a refrigerator to avoid unpleasant odour.can be used in regional, country, or local laboratories. Most methods depend 32 IODINE DEFICIENCY DISORDERS n Methods with ammonium persulfate (Method A)persulfate at 90-110 o and a spectrophotometer, which are both inexpensive instruments. n (see Annex 3). n Another, semi-quantitative method is based on the iodide-catalyzedthe procedure requires the manufacturerÕs pre-packed columns. 33 IODINE DEFICIENCY DISORDERS n sealed cassettes and heated to 110 o reduction reaction carried out and read on a microplate reader.analysed in one day, depending on manufacturersÕ supplies.Criteria for assessing urinary iodine methods are reliability, speed, technicalsuppliers, safety, and cost. The choice among the above and other methodsDue to the potential hazards of chloric acid, Method A using ammoniumpersulfate for chloric acid in the digestion step (see Annex 3). Results area recognized reference laboratory.Active efforts are now in progress, both to define performance criteria forpriority for ensuring sustainability of iodine sufficiency. 34 IODINE DEFICIENCY DISORDERS Most of the above methods perform reliably, although some of the newer onesrange is desired. The coefficient of variation is generally under 10% for allSince casual specimens are used, it is desirable to measure a sufficientdeterminations from a defined sampling group are sufficient.at low cost and to characterize the distribution according to different cut-offpoints and intervals. The cut-off points proposed for classifying iodinenutrition into different degrees of public health significance are shown inTable 5.tendency. Likewise, percentiles rather than standard deviations should bepopulation which has no iodine deficiency, i.e. at least 50% of the sampleAlternatively, the first quintile (20th percentile) should be at least 50 35 IODINE DEFICIENCY DISORDERS Table 5: Epidemiological criteria Median Iodine intake Iodine nutrition iodine (mg/l) InsufficientSevere iodine deficiency 20-49InsufficientModerate iodine deficiency 50-99InsufficientMild iodine deficiency100-199Adequate200-299More thanRisk of iodine-inducedadequatehyperthyroidism within&#x 20-;㦘 300ExcessiveRisk of adverse healtheven though populations may have attained iodine sufficiency by medianWith rapid global progress in correcting iodine deficiency, examples of iodineand poorly monitored (). Tolerance to high doses of iodine is quite variable, 36 IODINE DEFICIENCY DISORDERS The major epidemiological consequence of iodine excess is iodine-inducedhyperthyroidism (IIH) (30, 31). This occurs more commonly in older subjectswith pre-existing nodular goitres, and may occur even when iodine intake isIodine intakes above 300 mg/l per day should generally be discouraged,particularly in areas where iodine deficiency has previously existed.In these situations, more individuals may be vulnerable to adverse healthIn populations characterized by longstanding iodine deficiency and rapidincrement in iodine intake, median value(s) for urinary iodine above 200 mg/lare not recommended because of the risk of iodine-induced hyperthyroidism.30, 31). Beyond this period of time, medianvalues up to 300 mg/l have not demonstrated side-effects, at least not inpopulations with adequately iodized salt. 4.3Thyroid size Ultrasonography provides a more precise and objective method. However,Both methods are described below. Issues common to palpation and ultrasound 4.3.1 Thyroid size by palpation deficiency, the type and effectiveness of iodine supplementation, age, sex,goitre and is still recommended (see Table 6). 37 IODINE DEFICIENCY DISORDERS a survey, which is relatively easy to conduct, and training of personnel. These Neonates: neonates, whether by palpation or ultrasound. Performance is poor. School-aged children easily accessible. However, the highest prevalence of goitre occurs duringThe smaller the child, the smaller the thyroid, and the more difficult it is toAlternatively, children can be surveyed in households. For further discussion, Adults: especially sensitive to marginal iodine deficiency. Often they are relativelyTechniqueThe subject to be examined stands in front of the examiner, who looks carefully 38 IODINE DEFICIENCY DISORDERS Finally, the examiner palpates the thyroid by gently sliding his/her own thumbIf necessary, the subject is asked to swallow (e.g. some water) when beingexamined - the thyroid moves up on swallowing. The size of each lobe of thepresented in Table 6.Table 6: Simplified classification of goitre* by palpation Grade 0 No palpable or visible goitre. Grade 1 not enlarged fall into this category. Grade 2 A swelling in the neck that is clearlyvisible when the neck is in a normal position* A thyroid gland will be considered goitrous when each lateral lobe has a volumeThe specificity and sensitivity of palpation are low in grades 0 and 1 due to a4 Another method is to stand behind the subject with the neck in the neutral positionand hold the fingers (not thumb) over the area of the gland. The person is asked to 39 IODINE DEFICIENCY DISORDERS Table 7 gives the epidemiological criteria for establishing IDD severity, basedbe used to signal the presence of a public health problem. This recommendationthe prevalence of goitre should be quite low. The cut-off point of 5% allows bothTable 7: Epidemiological criteria for assessing None Mild Moderate Severe Total goitre 0.0-4.9%5.0-19.9%20.0-29.9%may not return to normal for months or years after correction of iodine deficiency. 4.3.2 Ultrasonography is a safe, non-invasive specialized technique, which provides 40 IODINE DEFICIENCY DISORDERS Feasibility5Portable (weight 12-15 kg) ultrasound equipment with a 7.5 MHz transducercurrently costs about US $15,000. A source of electricity is needed, and theInterpretationResults of ultrasonography from a study population should be compared withData from many countries have emphasized the importance of establishingnormative values for the populations being examined. Normative values for required, which in some populations is not known with certainty. A limitation of 4.4Blood constituents Two blood constituents, TSH (thyroid stimulating hormone or thyrotropin)survey, blood spots on filter paper or serum samples can be used to measure 41 IODINE DEFICIENCY DISORDERS In iodine deficiency, the serum T4 is typically lower and the serum T3 higherthan in normal populations. However, the overlap is large enough to make 4.4.1Thyroid stimulating hormone (TSH) TSH rises when serum T4 concentrations are low, and falls when they areHowever, the difference is not great and much overlap occurs betweenchildren and adults is not a practical marker for iodine deficiency, and itsIn contrast, TSH in neonates is a valuable indicator for iodine deficiency.and hence iodine turnover is much higher. This high turnover, which isexaggerated in iodine deficiency, requires increased stimulation by TSH.In iodine sufficient populations, about 1 in 4000 neonates has congenital 42 IODINE DEFICIENCY DISORDERS To detect congenital hypothyroidism and initiate rapid treatment, mostTSH elevations which are 20 mIU/l whole blood or higher, the availability ofnormal. This permits detection of transient hyperthyrotopinemia. To be broadlyserum, are well established and widely available. Typically, a few drops ofHIV or hepatitis infection from dried blood spots is extremely low.will be a spin-off. Hence the only additional cost will be for data analysis. 43 IODINE DEFICIENCY DISORDERS to assess community iodine deficiency. Less expensive means for obtainingbudgets are low. In such countries, mortality among children under five is highcountries. Most have been carefully standardized, and perform adequately.deficiency.of iodine deficiency. It may be higher than 40% in severe endemic areas.delivery or even the umbilical area of the baby. Beta-iodine increases TSH 4.4.2Thyroglobulin (Tg) for thyroid hormone synthesis. Normally, small amounts are secreted or leak 44 IODINE DEFICIENCY DISORDERS deficiency, particularly goitre. The laboratory technique is similar to that forcommercially or studied further. 45 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS 5.1Overview study population, and that the surveys are carried out as efficiently as possible. 5.2Salt monitoring Salt monitoring at the site of production is the responsibility of the salt producer. 47 IODINE DEFICIENCY DISORDERS At the actual point of entry, customs officers can realistically be expectedany kind of representative sampling. Suspect salt should be held at the border.However, it should be noted that salt may be imported for industrial purposesan attractive option, but is difficult to implement in practice. Unloading bagsfrom a lorry or railway wagon to check a consignment thoroughly is difficult,All salt samples should be carefully labelled before dispatch to the laboratory.Where a specific producer consistently fails to comply, appropriate legal steps 48 IODINE DEFICIENCY DISORDERS Monitoring salt at the community levelSalt monitoring, using test kits, should be conducted at the community level toensure that only iodized salt is on sale to the public. This should be carried out 5.3Iodine status assessment These notes are intended as a general guide to the principles underlying therecommended that expert epidemiological help be sought at an early stage incluster. In a defined geographical area, thirty clusters should be studiedcan lead to estimates that differ substantially from the true prevalence ( 49 IODINE DEFICIENCY DISORDERS actually enrolled in the schools selected for the survey.Within each cluster, a specified number of school-aged children or adult womenare selected for study. Each selected subject provides a urine specimen andefficient and practical approach for performing an iodine status or an IDDprevalence survey. However, school-based PPS cluster surveys may not beappropriate under all circumstances, as shown in Table 8.One 30-cluster survey is not sufficient for all countries, particularly those withsurvey. 50 IODINE DEFICIENCY DISORDERS Table 8: Circumstances when school-based Reason EffectRecommended action come from better offdifference proceed 51 IODINE DEFICIENCY DISORDERS In a school survey, the thirty children selected for urine collection should beIn a household survey, the team should identify the centre of the chosen 5.4Combined micronutrient deficiency surveys IDD prevalence surveys may be efficiently combined with those aimed atsalt sample at the same time. Alternatively, the nearest school to the selected 52 5.5IDD surveys in areas with no prevalence data or the entire enrolment if this is a lower number. For instance, assessment of 5.6Sentinel surveillance to be used as an instrument for the regular monitoring of IDD control. To assess 53 IODINE DEFICIENCY DISORDERS It is, however, important to be flexible when establishing a system for monitoring 5.7Measuring progress towards achieving Periodic prevalence surveys, as described earlier in this section, are necessary 5.8Target groups for surveillance IDD surveillance because of their combined high vulnerability, easy access,and applicability to a variety of surveillance activities. Affected childrenestimates (see Table 8). If school enrolments or attendance are low, 54 IODINE DEFICIENCY DISORDERS Women of childbearing age:deficiency. However, after age 30 goitre rates are no longer reliable indicatorsareas, women may go to the fields during the day. In some countries, manyElevated TSH levels, especially during infancy, suggest a deficiency of iodine.However, this approach is recommended for monitoring IDD control only when 5.9Interpreting and presenting results Taken alone, raw results from a survey do not mean very much. They must be100 or so, then processing by hand is fairly easy. With large numbers of data,easier.sampling. Theoretically, data should be importable from one to the other,but in practice this is not always easy. 55 IODINE DEFICIENCY DISORDERS of variability, or spread of the distribution. Unfortunately, many IDD parametersare not normally distributed. Rather, the results may be highly skewed in onethe measure of central tendency. The median is the same thing as thehalf are below. It is equidistant from either extreme.sense of shape to the distribution of values. However, it has been customaryIt should be noted that in carrying out a survey, only a sample of individuals 56 IODINE DEFICIENCY DISORDERS In compiling overall results of IDD surveys, e.g. at the national level, it isimportant not to simply take averages of subnational data. the overall result obtained may be biased. Rather, the following guidelines n Results from prevalence surveys in different regions should be weighted according to population size, before combining them. For example, goitre prevalence data should be adjusted by the to make this adjustment. n should be treated in a similar way. (These are both numerical n Results from sentinel surveillance data are not nationallyrepresentative data, and therefore should not be presentedas such. Instead, the median of medians from each sentinel 57 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS Indicators of the sustainable elimination of IDD (see also Table 9). n in a quantity that is sufficient to satisfy the potential n 95% of salt for human consumption must be iodizedaccording to government standards for iodine content,at the production or importation levels; n the percentage of food-grade salt with iodine contentof at least 15 ppm, in a representative sample of households,must be equal to or greater than 90%; and n iodine estimation at the point of production or importation,and at the wholesale and retail levels, must be determinedby titration; at the household level, it may be determined byeither titration or certified kits.With regard to the populationÕs iodine status: n the median urinary concentration should be at least 100 mg/l,with less than 20% of values below 50 mg/l; and n the most recent monitoring data (national or regional) shouldhave been collected in the last two years. 6666659 IODINE DEFICIENCY DISORDERS At least eight out of the following ten programmaticindicators should occur: n the elimination of IDD (this council should be multidisciplinary,the salt industry, the media, and consumers, n evidence of political commitment to universal salt iodizationand the elimination of IDD; n appointment of a responsible executive officer for the IDD n legislation or regulations on universal salt iodization (whilesalt, if the latter is not covered this does not necessarily n commitment to assessment and reassessment of progressin the elimination of IDD, with access to laboratories able toprovide accurate data on salt and urinary iodine; n a programme of public education and social mobilization onthe importance of IDD and the consumption of iodized salt; n regular data on salt iodine at the factory, retail and n regular laboratory data on urinary iodine in school-aged n cooperation from the salt industry in maintenance of quality n a database for recording of results or regular monitoringif available, neonatal TSH, with mandatory public reporting. 60 IODINE DEFICIENCY DISORDERS Table 9: Summary of criteria for monitoring progress IndicatorsGoa using adequately iodized salt�90%* Urinary iodine g/lg/l Programmatic indicators Attainment of the indicatorsAt least specified on the opposite page8 of the 10WHO, UNICEF, ICCIDD, and other appropriate organizations. 61 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS References The damaged brain of iodine deficiency. New York, Cognizant2. WHO, UNICEF, ICCIDD.World Health Organization, 1211 Geneva 27, Switzerland).Dictionary of epidemiology, 3rd ed. New York,International Epidemiology Association, Oxford University, 1995.4. WHO, UNICEF, ICCIDD. Development, World Health Organization, 1211 Geneva 27, Switzerland)., 1983, 2:1126-1129.New York, Plenum Press, 1989:231ff.7. Delange F. Endemic cretinism. In: Braverman LE, Utiger RD, eds.9. Dunn JT. WhatÕs happening to our iodine? 63 IODINE DEFICIENCY DISORDERS 10. Delange F. The disorders induced by iodine deficiency. 11. Pandav CS, Rao AR. 12. MI, WHO, ICCIDD, USAID, PAMM, UNICEF. Houston R et al., eds.salt program assessment tools (ISPAT).13. WHO, UNICEF, ICCIDD. Delange F et al., eds. held in Munich, Germany, 3-6 September 1997. Geneva, World HealthDevelopment, World Health Organization, 1211 Geneva 27, Switzerland).14. WHO, UNICEF, ICCIDD. Geneva, World Health Organization, 1999Department of Nutrition for Health and Development, World HealthOrganization, 1211 Geneva 27, Switzerland).15. WHO, UNICEF, ICCIDD. Report of the Joint FAO/WHO Expert Committee on Food Additives.Geneva, World Health Organization, 1991 (WHO Technical Report Series,17. MI, ICCIDD, UNICEF, WHO. Mannar V, Dunn J, eds. for the elimination of iodine deficiency. The Netherlands, ICCIDD, 1995. 64 IODINE DEFICIENCY DISORDERS 19. WHO, UNICEF, ICCIDD. Development, World Health Organization, 1211 Geneva 27, Switzerland).Volume 2. 8th World SaltSymposium. The Hague, 8-11 May 2000. Amsterdam, Elsevier, 2000:21. Delange F, de Benoist B, Alnwick D et al. Risks of iodine-inducedAtlanta, PAMM, 1995.programs. Report of a Training Workshop. Blantyre, Malawi 9-13 March Atlanta, PAMM, 1998.25. UNICEF, ICCIDD, PAMM, WHO, MI. Sullivan KM et al., eds. . Atlanta, PAMM, MI, ICCIDD, 1995.28. Dunn JT, Myers HE, Dunn AD. Simple methods for assessing urinary 65 IODINE DEFICIENCY DISORDERS 29. Ohashi T et al. A newly developed method for determination of urinaryepidemiology. 31. Todd CH et al. Increase in thyrotoxicosis associated with iodine32. Delange F, Bourdoux P, Ermans AM. Transient disorders of thyroidfunction and regulation in preterm infants. In: Delange F, Fisher D,Malvaux P, eds. . Basel, S. Karger, 1985:369-393.33. Missler U, Gutekunst R, Wood WG. Thyroglobulin is a more sensitiveBiochemistry,34. UNICEF, PAMM, MI, ICCIDD, WHO. Sullivan KM et al., eds. 2nd ed. UNICEF, PAMM, 2000.37. Dean AG et al. Epi Info, Version 6: a word processing, database, 66 IODINE DEFICIENCY DISORDERS annexes IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS annex The iodine content of iodated salt samples is measured using iodometrictitration (see References on the following page for further details).Description of the reactionThe reaction mechanism includes two steps: nLiberation of free iodine from salt: addition of H2SO4liberates free iodine from the iodate in the salt sample. nTitration of free iodine with thiosulfate: with free iodine to produce a blue colour. When addedamount of free iodine is left) the loss of blue colour, or (from (from (from salt) KI) H Titrimetric method for 1annex69 IODINE DEFICIENCY DISORDERS Reagent preparationThe preferred water for this method should be boiled distilled water, which1000 ml water. Store in a cool, dark place. This volume is sufficient forfor at least one month, if stored properly.water. Make to 100 ml with water. This volume is sufficient for 100 samples.The solution is stable indefinitely. Always add acid to water, Dissolve 100 g KI in 1000 ml water. Store in acool, dark place. This volume is sufficient for 200 samples. Properly storedin 100 ml double-distilled water. While stirring, add NaCl until no moreWhile cooling, the NaCl crystals will form on the sides of the beaker. When itdouble-distilled water. Continue to boil until it completely dissolves. Add theday, since starch solution cannot be stored.UNICEF, PAMM, MI, ICCIDD, WHO. Sullivan KM et al., eds. Atlanta, PAMM, MI, ICCIDD, 1995.De Maeyer EM, Lowenstein FW, Thilly CH. The control of endemic goiter.Geneva, World Health Organization, 1979. 70 IODINE DEFICIENCY DISORDERS Method for determiningthyroid size by ultrasonography during data entry. Portable ultrasound equipment is relatively rugged,but requires electricity. However, it can be operated from a car battery with theaid of a transformer. Trained operators can perform up to 100 or moreexaminations per day. annex271 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS Heating block (vented fume hood not necessary), colorimeter, thermometer,1.0 M Ammonium persulfate: Dissolve 114.1 g H In a 2000 ml Erlenmeyer flask, place 20 g As filter, store in a dark bottle away from light at room temperature. The solution annexMethod for measuring urinary iodine 373 IODINE DEFICIENCY DISORDERS Ceric ammonium sulfate solution: Dissolve 48 g ceric ammonium sulfatein 1 litre 3.5 N H2SO4. (The 3.5 N H2SO4 is made by slowly adding 97 mlconcentrated (36 standards should be included in each assay. 74 IODINE DEFICIENCY DISORDERS 3. The exact temperature, heating time, and cooling time may vary. However,within each assay, the interval between the time of addition of cericinterval additions of CAS, up to 120 tubes can be read in a single assay.to achieve different concentrations or a different curve shape, if conditions6. If necessary, this method could probably be applied without a heating block,using a water, oil, or sand bath, but this is not recommended. It is essential7. Test tubes can be reused if they are carefully washed to eliminate any8. Various steps of this procedure are suitable for automation. For example,the colorimetric readings can be done in microtiter plates with a scanner, andthe standard curves plotted and read on a simple desk computer.ICCIDD, UNICEF, WHO. Dunn JT et al. The Netherlands, ICCIDD, 1993. 75 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS the central statistical office within the Ministry that performs the census forthe country.From the census data, select the data for the area chosen for the survey.Make a list with four columns (see Table 10). The first column lists the nameof each community. The second column contains the total population of eachcommunity. The third column contains the cumulative population - this isusing random number tables, and the sampling interval is added cumulatively.In the fictitious area of El Saba, there are fifty communities (Table 10). Methodology for selection of survey sites by PPS samplingannex4 77 IODINE DEFICIENCY DISORDERS In Table 10 on the opposite page, the first column contains the names of thecommunities, the second column the population of each community, and the n Calculate the sampling interval by dividing the totalpopulation by the number of clusters. In this example,24,940 / 30 = 831. n Choose a random starting point (x) between 1 andthe sampling interval (k, in this example, 831) byusing the random number table. For this example, n The first cluster will be where the 710th individualis found, based on the cumulative population column, n Continue to assign clusters by adding 831 cumulatively.If two clusters are selected in one community, when the survey is performedpopulation size and perform a survey in each section. Similarly, if three ormore clusters are in a community, the community would be divided into three 78 IODINE DEFICIENCY DISORDERS Table 10: Selection of communities in El SabaUtural600 600Ban Vinai40010,88013Mina7001,3001Puratna22011,100Bolama3501,6502Kegalni14011,240Taluma6802,3803Hamali-Ura 8011,320War-Yali4302,810Kameni41011,73014Galey2203,030Kiroya28012,010Tarum 403,070Yanwela33012,340Hamtato1503,2204Bagvi44012,78015Nayjaff 903,310Atota32013,100Nuviya3003,610Kogouva12013,22016Cattical4304,0405Ahekpa 6013,280Paralai1504,190Yondot32013,600Egala-Kuru3804,570Nozop 1,78015,38017Uwarnapol3104,8806Mapazko39015,77019Hilandia 2,0006,88078Lotohah 1,50017,27020Assosa7507,6309Voattigan96018,23021Dimma2507,880Plitok42018,650Aisha4208,30010Dopoltan27018,900Nam Yao1808,480Cococopa 3,50022,40023Mai Jarim3008,780Famegzi40022,820Pua1008,880Jigpelay21022,840Gambela7109,59011Mewoah 5022,890Fugnido1909,88012Odigla35023,24028Degeh Bur150 10,030Sanbati 1,44024,68029Andidwa26024,94030 PopulationCumulativeClusterClusterPopulationNameNameCumulativepopulation79 IODINE DEFICIENCY DISORDERS age for the survey. Because the age range for the survey is 6-12 years, theIdeally, the Ministry of Education will have such a listing. n Is there a list of all schools in the geographic areawith the appropriate age range? n However, if enrolment information cannot be obtained easily there may be 80 IODINE DEFICIENCY DISORDERS Method 1 - schools when their enrolments are known earlier in this chapter, should be used. First, generate a list of schools similarto that shown in Table 11. Second, determine the cumulative enrolment.Finally, select schools using the same PPS method as described for selectingcommunities (see Table 10).Table 11: Selection of schools using the PPS method SchoolEnrolmentCumulative enrolment Utural 600 600Mina 700 1,300Bolama 350 1,650 Method 2 - a list of schools is available, but enrolments arenot known When a list of schools is available but the enrolment of each school is not n Obtain a list of the schools and number them from 1 to N(the total number of schools). n ), usually thirty. n Calculate the Òsampling intervalÓ (k) by N/n (always round downto the nearest whole integer). n and include that school in the survey. n Select every kth school after the first selected school. 81 IODINE DEFICIENCY DISORDERS For illustrative purposes, Table 12 lists fifty schools. The following methodStep one:There are fifty schools, therefore Step two:The number of schools to sample is eight;Step three:The sampling interval is 50 / 8 = 6.25; round down tothe nearest whole integer, which is 6; therefore, Step four:Using a random number table, select a numberAccordingly, the first school to be selected wouldStep five:Select every sixth school thereafter; in this example,again go to the random number table to pick a number. The school thatcorresponds to that random number is removed from the survey.To analyse properly the data collected using systematic sampling, additionalNote that usually thirty clusters are selected; the eight indicated in Table 12have been selected in this example for illustrative purposes only. 82 IODINE DEFICIENCY DISORDERS Table 12: Selection of schools School Selected School Selected 1Utural26Ban Vinai2Mina27PuratnaY3BolamaY28Kegalni4Taluma29Hamali-Ura5War-Yali30Kameni6Galey31Kiroya7Tarum32Yanwela8Hamtato33BagviY9NayjaffY34Atota10Nuviya35Kogouva11Cattical36Ahekpa12Paralai37Yondot13Egala-Kuru38Nozop14Uwarnapol39MapazkoY15HilandiaY40Lotohah16Assosa41Voattigan17Dimma42Plitok18Aisha43Dopoltan19Nam Yao44Cococopa20Mai Jarim45FamegziY21PuaY46Jigpelay22Gambela47Mewoah23Fugnido48Odigla24Degeh Bur49Sanbati25Mezan50Andidwa Method 3 - an extremely large number of schools In very large populations, it may not be possible or efficient to select schoolsmuch time and effort to select schools using either of these methods. 83 IODINE DEFICIENCY DISORDERS Accordingly, another approach may be more appropriate. and cumulative populations similar to the PPS selection described earlier.Next, determine the number of schools to survey, based on the cumulativenumbers. Finally, and while not technically correct, it would be acceptable toPPS methodology. Other possibilities 2nd ed. UNICEF, PAMM, 2000. 84 IODINE DEFICIENCY DISORDERS column of Table 14. The data have been entered into a spreadsheet on apersonal computer for ease of calculation. However, with small numbers such Steps in processing the data 1.Before proceeding, carefully check the data entered against2.Next, sort the data from highest to lowest, or vice-versa.The spreadsheet will do this automatically. (In Microsoft use the Data Analysis function on the Tools menu, and selectÒValueÓ in Table 14, starting with the highest value. The nextdata point. Accordingly, use the middle pointg/l, respectively.4.Next, calculate the number of values below 100, 50, and 20 respectively. The ranking will allow this to be done very easily.5.Check if any values are above 500 Summarizing urinary iodine data: a worked exampleannex585 IODINE DEFICIENCY DISORDERS 6.The 20The 20()th percentile(P20) is 82.4 mg/l and P80 is 191.8 mg/l.7.The ÒDescriptive StatisticsÓ function of Data Analysis in8.In addition, the data can be shown as a histogram using theTable 13: Summary of resultsNumber 98 percentile 82.4 percentile191.8 g/l 33.7%g/l 5.1%g/l 1.0%g/l 1.0%These results indicate that there is no iodine deficiency, and that salt iodization 86 IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildren UI(g/l) Value Rank Percent 141535 1 100.00%138480 298.90%138395 397.90%Standard error154340 496.90%162320 595.80%Mode138 26295 694.80%Standard deviation87.88117 63273 792.70%Sample variance 111273 792.70%120264 991.70% 652611090.70%Range5251902401189.60%Minimum101422321287.60%Maximum5351382321287.60%Sum13989 952241486.50%Count982732081585.50%Confidence1322001683.50% level (95.0%)1642001683.50% 661981882.40%1581931980.40%1141931980.40%1181902179.30%2321882278.30%1451802377.30% 941742476.20% 901642575.20%1221622674.20%1141602773.10%3401582872.10%1931542971.10%1351503070.10%2611463168.00% 751463168.00% 631453367.00% 87 IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildren g/l) Value Rank 2641443465.90%1421423563.90%1741423563.90%1211413762.80%3951403860.80%3201403860.80%2401384057.70%1401384057.70% 661384057.70%1461354356.70%1151334455.60% 821324554.60% 821284653.60%5351244752.50% 741224850.50% 351224850.50% 831215049.40%1041205146.30% 641205146.30%2081205146.30% 491185445.30% 891175544.30%1091155642.20%1061155642.20% 321145840.20%1281145840.20%2321116039.10% 881106138.10%1151096237.10%1441086336.00% 861066435.00%1501046534.00%224 966632.90% 92 956730.90%180 956730.90%193 946929.80% 88 IODINE DEFICIENCY DISORDERS Table 14: Urinary iodine data in Cameroon schoolchildren g/l) Value Rank Percent Descriptive Statistics 133927028.80% 80907126.80% 87907126.80% 96897325.70%120887424.70%146877522.60%160877522.60%124867721.60% 90837820.60% 10827918.50% 55827918.50%108808116.40%480808116.40% 80758315.40%122748414.40%198668512.30%200668512.30% 87658711.30%200648810.30%1886389 8.20% 546389 8.20%2735591 7.20%1205492 6.10%1404993 5.10%1104294 4.10% 423595 3.00% 953296 2.00%1172697 1.00%2951098 .00% 89 IODINE DEFICIENCY DISORDERS Figure 4: Frequency table and histogramto show distribution of urinary iodine valuesafter iodization in Cameroon Urinary iodine (mg/l) Frequency 0-49 6 50-9927100-14935150-19913200-249 7250-299 5300-349 2350-399 1400-449 0450-499 1500-549 1550-599 0 4035 0-49 50-99 Urinary iodine (mg/l) Frequency 001112135762735 90 IODINE DEFICIENCY DISORDERS ASIN Law, The Philippines An Act Promoting Salt Iodization Nationwide and for Related Purposes (ASIN LAW)Congress of the PhilippinesMetro ManilaBegun and Held in Metro Manila, on Monday the twenty-fourth day of July,,AN ACT PROMOTING SALT IODIZATION NATIONWIDEAND FOR RELATED PURPOSESBe it enacted by the Senate and House of Representativesof the Philippines in Congress assembled:Title. Ð This Act shall be known as ÒAn Act for Salt Iodization Nationwide (ASIN)Ó.Declaration of Policy.the health of the people, to maintain an effective food regulatory system, and to provide the entire populationa)Contribute to the elimination of micronutrient malnutrition in the country, particularly iodine deficiencydisorders, through the cost effective preventive measure of salt iodization;b)require all producers/manufacturers of food-grade salt to iodize the salt that they produce, manufacture,c)require the Department of Health (DOH) to undertake the salt iodization program and for its Bureau of Foodand Drugs (BFAD), to set and enforce standards for food-grade iodized salt and to monitor complianced)require the local government units (LGUs), through their health officers and nutritionist-dieticians, or in their 91 IODINE DEFICIENCY DISORDERS e)require the Department of Trade and Industry (DTI) to regulate and monitor trading of iodized salt;f)direct the Department of Science and Technology (DOST), in collaboration with the Technology andg)authorize the National Nutrition Council (NNC), the policy-making and coordinating body on nutrition,h)provide mechanisms and incentives for the local salt industry in the production, marketing, and distributioni)ensure the sustainability of the salt iodization program.Definition of Terms Ð For purposes of this Act, the following terms shall mean:Micronutrient malnutrition Ð a disorder resulting from deficiencies in vitamin A, iron, iodine and othermicronutrients which the body needs in minute quantities everyday.which leads to the reduction of intellectual and physical capacity affecting everyone who is iodine-deficientand may manifest as goiter, mental retardation, physical and mental defects, and cretinism.BFAD.Regulatory requirementsenactmentÕs related to food quality and safety, purity, nutritional composition, and other aspects of foodManufacturerSubsistence producer/manufacturermetric tones (2m.t.) per year.Small producer/manufacturermore than two metric tones (2m.t.) to three hundred metric tons (300 m.t.)per year.Medium producer/manufacturermore than three hundred metric tons (300 m.t.) to two thousand metric tons (2,000 m.t.) per year.Large producer/manufacturertwo thousand metric tones (2,000 m.t.) per year.a)This Act shall apply to the entire salt industry, including salt producers/manufacturers, importers, traders and 92 IODINE DEFICIENCY DISORDERS b)Iodized salt that conforms to the standards set by the BFAD to meet national and nutritional needs shallProvided, That the implementation of this Act shall be enforced over astaggered period of one (1) year for large and medium producers/manufacturers; two (2) years for smallc)All food outlets, restaurants, and stores are hereby required to make available to customers only iodized saltin their establishment upon effectivity of this Act. These establishments shall be monitored with the help ofthe LGUs through its health officers and nutritionist-dietitians, or in their absence, the sanitary inspectors tod)In areas endemic to iodine deficiency disorders, iodized salt shall be made available. Local governmentofficials at the provincial and municipal levels shall provide mechanisms to ensure enforcement of thise)All food manufacturers/processors using food-grade salt are also required to use iodized salt in theits effectivity: Provided, That the use of iodized salt shall not prejudice the quality and safety of their foodProvided, however, That the burden of proof and testing for any prejudicial effects due to iodizedsalt fortification lies n the said food manufacturers/processor.f)Salt producers/manufacturers shall register with the BFAD, which shall maintain an updated registry of saltg)All food-grade salt shall be labeled in a manner that is true and accurate, not likely to mislead purchasersand in accordance with the requirements prescribed by the BFAD.h)For a period of three (3) years from the effectivity of this Act, the DOH shall provide free iodized salt toa)the DTI is hereby required to assist and support local salt producers/manufacturers in upgrading theirb)the Cooperative Development Authority (CDA) shall assist the formation of cooperatives of local saltc)the DOST, in collaboration with the TLRC, shall develop and implement comprehensive programs for thed)the Department of Environment and Natural Resources (DENR) and other appropriate government agenciesdisseminated and promoted through organized, systematic and nationwide information campaign which shallPhilippine Information Agency (PIA), provincial science centers, private sector, and students.The implementing agency, in coordination with the PIA, shall seek the cooperation of the media sector 93 IODINE DEFICIENCY DISORDERS programs and activities. It shall coordinate the efforts of all agencies concerned and monitor the implementationprogress of the salt iodization program and offer recommendations for its improvement. - as the Food, Drugs and Cosmetics Act, As Amended: Provided, That any person, whether natural or juridical,who violates any of the provisions of this Act or any of the rules and regulations promulgated for its effectiveProvided, however, That if the violation is committed by any officer,director or member of a business and a juridical entity acting beyond the scope of his authority, such officer,Provided, further, That suchviolator shall suffer a revocation of its business permit and/or a ban of its product from the market: Provided,, That the BFAD, in coordination with the LGUs concerned, shall be authorized to impose and collect thefines from the violators, and such collections shall accrue to the BFAD for its use in the implementation of thischarged to the appropriations of the agencies concerned as may be appropriated, under the current GeneralAppropriations Act. Thereafter, such amount as may be necessary for its implementation shall be includedSEC. 11. shall formulate the necessary rules and regulations for the effective implementation of this Act within sixty (60)shall not be affected by such declaration and shall remain valid an enforceable.Effectivity Clause - This Act shall take effect fifteen (15) days after its publication in theOfficial Gazette or in two (2) national newspapers of general circulation, whichever is earlier.This Act, which is a consolidation of Senate Bill No.112 and house Bill No.45 was finally passed by theSenate and the House of Representatives on November 16, 1995 and November 5, 1995, respectively.IMPLEMENTING RULES AND REGULATIONS OF REPUBLIC ACT No. 8172AN ACT PROMOTING SALT IODIZATION NATIONWIDE AND FOR RELATED PURPOSESapproved by the President on 20 December 1995 and which took effect on 20 January 1996, mandating theSection 11 of said Act mandating the DOH to formulate the Implementing Rules and Regulations (IRR) incooperation with the other government agencies involved in the implementation of the law, the following Rulesand Regulations are hereby adopted to implement effectively the provisions of R.A. No. 8172.b) All restaurants and other food establishments where food is being served hot or sold, 94 IODINE DEFICIENCY DISORDERS c) All food manufacturers/processors using salt in their manufacturing processes,d) All local government units (LGUs),f) All non governmental agencies and related professional organizations; andINTERPRETATIONS Ð means the exchange, transmittal, conveyance, consignment, supply, delivery, trade, sale,suitable fortificant as recommended by DOH, taking into consideration the circumstances of quality,effectiveness, stability, availability and new discoveries that can bring salt iodization in the most effectiveand economic manner.Food manufacturers/processorswhich leads to the reduction of intellectual and physical capacity affecting everyone who is iodine deficientManufacturer1)Large producer/manufacturer Ð one who produces, imports, trades and /or distributes salt exceedingtwo thousand metric tons (2,000 MT) per year.2)Medium producer/manufacturer Ð one who produces, imports, trades in, distributes salt ranging frommore than three hundred metric tons (300 MT) to two thousand metric tons (2,000 MT) per year. 95 IODINE DEFICIENCY DISORDERS 3)Small salt producer/manufacturer Ð one who produces, imports, trades in, or distributes saltyear.4)Subsistence producer/manufacturer Ð one who produces, trades in or distributes salt not exceeding twometric tons (2MT) of salt per year.Micronutrient malnutrition Ð refers to a disorder resulting from deficiencies in vitamin A, iron,iodine and other micronutrients which the body needs in minute quantities every day.trade or import iodized salt with the Bureau of Food and Drugs (BFAD) or appropriate LGU.other enactmentÕs related to food quality and safety, purity, nutritional composition, and otherprescribed by the BFAD of the DOH.TradingSTANDARDS and REQUIREMENTSconform with the standards formulated by the BFAD or DOH which is in Annex 1 of these implementing rules andregulations. Such standards shall be periodically reviewed and updated by the BFAD in consultation with theSECTION 3. To ensure the quality of iodized salt prior to distribution, all manufacturers of iodized salt shalla)Iodine levels testing: at regular intervals on a daily basis, samples of iodized salt shall be collected from theb)Equipment inspection: at least twice daily to ensure its proper operation.c)Mixing process: shall be monitored regularly to ensure consistent mixing and homogeneity of iodine content 96 IODINE DEFICIENCY DISORDERS d)Monitoring of salt ready for distribution: each lot shall be sampled to ensure conformity to prescribede)Packaging and labeling inspection shall be routinely conducted to ensure the integrity of the package andf)Record keeping: daily control charts and weekly summaries of activities and corrective actions taken shallSECTION 7. Within one (1) year from the effectivity of the Act, all food manufacturers and processors shallutilize iodized salt in their products expect when the use of iodized salt will have an adverse effect on a specifiedproduct. In such cases, the food manufacturers/processors shall present appropriate evidence to the BFAD whichshall serve as basis for exemption from compliance with Section 5(e) of this Act. The BFAD shall submit to theannually.REGISTRTION OF IODIZED SALT MANUFACTURERS AND SALT IMPORTERS/DISTRIBUTORSSECTION 1. All iodized salt manufacturers and salt importers/distributors shall register with the BFADaccording to the following schedule: The large and medium manufacturers shall register within one (1) year fromthe effectivity of this Act; small manufacturers within two (2) years, and subsistence manufacturers within five (5)years. After the effectivity of these IRR, new salt producers/manufacturers shall register before operation.SECTION 2. The BFAD shall issue a License to Operate (LTO) to iodized salt manufacturers and saltand 3. Those engaged in manual salt iodized shall secure a Certificate of Training from the DOH before they canbe provided with a LTO. If an importer is already holding a valid LTO as importer, he/she need not apply foranother license; however, the importer must comply with the technical requirements and their products shall beSECTION 3. The BFAD may delegate to the LGUs its authority to issue LTOs in cities and municipalitiesother than those in the National Capital Region (NCR) and in areas where the seat or office of the DOH-RegionalField Offices (RFOs) is located, through a memorandum of agreement between the BFAD and the LGU, or theBFAD and the RFO, with the suggested terms and conditions contained in Annex 4 hereof. Such agreements shall 97 IODINE DEFICIENCY DISORDERS ROLE OF AGENCIES CONCERNED IN THE SALT IODIZATION PROGRAMSECTION 1. The DOH shall lead in the implementation of this Act. Specifically, it shall:a)Spearhead a public information drive in cooperation and coordination with the LGUs and other agenciesProvincial Science Centres-Department of Science and Technology (DOST), private sector and students. Allb)Provide training on salt iodization technology and quality assurance and control through its NutritionalService (NS) in coordination with the DOST and the Technology and Livelihood Resource Centre (TLRC);c)Set and enforce standards for food-grade iodized salt and monitor compliance thereof by the food-grade saltmanufacturers through its BFAD.a)The formulation of ordinances and information campaigns promoting the availability and use of iodized salt;b)Provision of budget for health and nutrition programs;c)Assistance to other governmental agencies in the implementation of the salt iodization program;d)Monitoring the quality of salt as provided by law through its respective health officers and nutritional-dietitians or, in their absence, through the sanitary inspectors; ande)Establishment and maintenance of a list of salt producers in their respective territorial jurisdiction. A list ofregistered salt producers in every province shall be submitted to the BFAD within 6 months from theeffectivity of these IRR and shall be updated annually. The list shall reflect the following information per1)Name and address of company and/or owner2)Location of salt production site (sitio/barangay)3)Annual production capacity (in metric tons)4)Types of salt produced: -iodized salt -non-iodized salt-direct sale to consumers within the province-traders within the province-traders from other provinces/regions-food manufacturers within the province-food manufacturers outside the province/regionSECTION 3. The Department of Trade and Industry (DTI) shall assist and support local salt producers/and financial assistance for the procurement of salt iodization machines, packaging equipment and technology,and fortificants; and by ensuring the systematic distribution of the iodized salt in the market. Specifically, it shall:a)Regulate an monitor the trading of iodized salt in accordance with R.A. 7581 otherwise known as the Priceb)Provide incentives to the salt industry by including salt iodization as a priority investment program of the 98 IODINE DEFICIENCY DISORDERS c)Assist salt producers/manufacturers obtain soft loan for machines, equipment and other materials suchas fortificant and other chemicals needed to upgrade the salt industry, through its Bureau of Small andd)Provide assistance to salt producers/manufacturers on matters of package design and packaging technologySECTION 4. The Department of Science and Technology (DOST) shall develop and implementaSECTION 5. The Technology and Livelihood Resource Centre (TLRC) shall:a)Assist the DOST in the development and implementation of a comprehensive program for the acquisition of,b)Provide funding assistance to qualified small producers, especially if located in one of the priority provincesin support of the governmentÕs poverty alleviation and industry decentralization drive;c)Develop a program of training entrepreneurs in setting up micro/cottage/small business enterprises to belocated in its Technology and Livelihood Development Centre (TLDC) in the provinces;d)Undertake an all-out information campaign to promote the use of iodized salt nationwide through its tri-subsistence salt producers/manufacturers so that they may organize themselves into cooperatives and undertakesalt iodization and marketing of iodized salt in the spirit of cooperativism. The organized cooperatives shall beconcerned agency/entity. The DENR shall ensure, through the Environmental Impact Statement (EIS) System, thatproposed activities near the salt farms do not adversely affect the latter. The DENR shall also monitor thehealth, labor and employment, environment and ecology.ADVISORY BOARDSocial Welfare and Development; Education, Culture and Sports; Science and Technology; the Interior and LocalGovernment; Labor and Employment; Trade and Industry; and Budget and Management; the National Economic 99 IODINE DEFICIENCY DISORDERS program from production and marketing, to public information campaign. It shall analyze the effectiveness of theevery end of December to the Congress of the Philippines on the status of the salt iodization program and offerSECTION 1. The BFAD Director is hereby authorized to impose an administrative fine to existing saltbe immediately applicable to salt producers/manufacturers/importers/traders newly established or organized afterthe effectivity of the Act. The LGUs are authorized to impose administrative fine to food service establishmentsand outlets one year after the effectivity of the Act. The administrative fine shall be in the amount of not less thanIn the imposition of the said administrative penalty, the imposable fine of One Thousand Pesos (P1,000.00) toThirty Thousand Pesos (P30,000.00) shall be considered minimum penalty. Thirty One Thousand Pesos(P31,000.00) to Sixty Thousand Pesos (P60,000.00) as medium penalty, and Sixty One Thousand Pesos(P.61,000.00) to One Hundred Thousand Pesos ((P100,000.00) as maximum penalty: provided that the maximumfine shall be in addition to the revocation of the offenderÕs License to Operate, and provided further that in allcases where the subject matter of the offence is a prohibited product, the Director shall order the recall and/orSECTION 2. When the offence is committed with the following circumstances, the minimum penalty shall bea)a history or record of satisfactory compliance with the rules and regulations prior to the commission of theoffence, or absence of previous violation of R.A. 8172 or its IRR; andb)lack of information on the part of the offender about the rules and regulations or requirements of the subjectmatter of the violation/offence.SECTION 4. The medium penalty shall be imposed when the offence committed is not attended by any ofSECTION 5. The BFAD Director may delegate the conduct of administrative investigation of any violationconfirmation by the BFAD Director before the same shall be deemed final and executory. In such case, the LGUmay be authorized by the BFAD Director to collect the fine that may be imposed provided that such fine collectedSEPARABILITY CLAUSEremaining provisions shall not be affected thereby and shall remain valid.These Implementing Rules and Regulations shall take effect thirty days after its publication in a newspaper of 100 IODINE DEFICIENCY DISORDERS STANDARD FOR IODIZED SALTor unrefined (crude) salt obtained from underground rock salt deposits or by evaporation of seawater or naturalbrine. The finished product shall be in the form or solid crystal or powder, white in color, without visible spots ofclay, sand, gravel, or other foreign matters.3.1Salt may be iodized with potassium iodate (KIOa)Dry mixing if salt is in powdered formb)Drip feeding or spray mixing if salt is in crystal formc)Submersion of salt crystals in iodated brine To ensure the stability of iodine, salt to be iodized must conform with the following purity require-Moisture max4% for refined saltNaCl, min97% (dry basis)Calcium and magnesium, max2%Water insoluble, maxArsenic as As0.5 mg/KgCadmium as Cd0.5 mg/KgLead as Pb2.0 mg/KgMercury as Hg0.1 mg/Kg Naturally present secondary products and contaminants in raw saltproducts, which are present in varying amounts depending on the origin and method of production of the salt, and4.3 Type of containers/PackageSampling PointBulk �(2kg)Retail (Production Site70-150 mg/kg60-100 mg/kgPort of Entry*70-150 mg/kg60-100 mg/kg* For imported iodized salt; also at importerÕs /distributorÕs warehouse 101 IODINE DEFICIENCY DISORDERS 5.1All additives used, including KIOCalcium/magnesium, Magnesium oxide; Tricalciumricalcium(6)]3 5.3 Emulsifiers Polysorbate 80 10 mg/kg 5.4 Processing aid Dimethylpolysiloxane 10 mg of residue/kg6.PackagingAll iodized salt shall be packed in woven polypropylene bags, clean and unused jute bags, or othernon-porous material with a lining of high density polyethylene to ensure the retention of appropriate iodinelevel at the time of consumption.7.Labelling7.1Iodized salt for commercial distribution shall carry appropriate labeling in accordance with BDADrules and regulations on labeling of prepackaged foods. Specifically, the following information shall be a)The name of the product, ÒIODIZED SALTÓ, printed in bold capital lettersb)Name and address of manufacturerc)Net weight (in metric units)d)Iodine compound usede)Chemical additives e.g. anticaking agents, emulsifiersf)Open date marking e.g. ÒBest BeforeÓ or ÒConsume BeforeÓ Dateg)Lot Identification Code (Repackers must use manufacturesÕs lot i.d. code)h)Storage instruction: STORE IN COOL DRY PLACE a)Same as in 7.1.1 (a), (c) to (h)b)Name and address of importer/local distributorc)Country of origin Labeling of Non-retail containerssection 7.1.1 (b), (d), (e) or in 7.1.2 (b) may not be declared if such bulk packages are intended for delivery 102 IODINE DEFICIENCY DISORDERS a)direct sunlight or near source of strong lightb)high temperature and humidityc)contamination with moisture e.g. rain, flood, etc.d)contamination with dust or filth from the environmentReferenceAn Act Promoting Salt Iodization Nationwide and for Related Purposes (ASIN LAW) and its Implementing Rules 103 IODINE DEFICIENCY DISORDERS 104 IODINE DEFICIENCY DISORDERS F. Azizi, DirectorP.O. Box 19395-4763Teheran, Islamic Republic of IranTel: 98-21-2409301-5Tel: 41-32-622.0302Tianjin Medical CollegeTianjin 300070Tel: 86-22-2352.5608F. Delange, Executive Director153, Avenue de la Fauconnerie1170 Brussels, BelgiumTel: 32-2-675.8543A. Duffielc/o WHO, 20 Avenue Appia1211 Geneva 27, SwitzerlandUniversity of VirginiaP.O. Box 511Charlottesville, VA 22908, USATel: 1-804-924.5929E-mail: jtd@avery.med.virginia.eduTel: 61-8-8267.3768E-mail: iccidd@a011.aone.net.auP. Jooste, Chief ScientistP.O. Box 19070Tygerberg 7505Tel: 27-21-938.0370E-mail: pieter.jooste@mrc.ac.za List of participants: IDD Consultation, Geneva 1999annex7105 IODINE DEFICIENCY DISORDERS M.G. Karmarkar, Senior AdviserNew Delhi 110029, IndiaTel: 91-11-371.0726Fax: 91-11-686.3522 Health and Director of PAMMTel: 1-404-727.4553E-mail: gmaberl@sph.emory.eduC. Pandav, Regional CoordinatorNew Delhi 110029, IndiaTel: 91-11-649.2693Fax: 91-11-686.3522Avenue Cuba 523Lima 11, PeruTel: 51-1-265.9118E-mail: epretell@per.itete.com.peTel: 1-404-727.5846E-mail: cdckms@sph.emory.eduJ.W. SchultinkSenior Adviser, MicronutrientsNew York, NY 10017, USATel: 1-212-326.7000C. Todd, Regional Health AdviserP.O. Box 4252Tel: 263-4-701914-5 ext. 203 106 IODINE DEFICIENCY DISORDERS IODINE DEFICIENCY DISORDERS 1211 Geneva 27, SwitzerlandTel: 41 22-791.3322World Health Organization20 Avenue Appia, 1211Tel: 41-22-791.3412G. A. Clugston, Director20 Avenue Appia, 1211Tel: 41-22-791.3326A. Verster, DirectorNasr City, Cairo 11371, EgyptTel: 202-670-25-35 107 Iodine D and Moni t A guide f n o f U disorders (IDD). It also presentswhether at the factory, importation recommendations oniodine; and on the characteristicsand criteria for selection of clinicalFinally, indicators are presentedelimination of IDD as a A guide for programme managers