Firm-Level and Public-Sector Costs Make Small-Scale Maize Flour Fortification Challenging in Uganda.

BACKGROUND: Maize flour in Uganda is milled by hundreds of enterprises, mostly small- (5-20 metric tons [MT]/day) and micro-scale (<5 MT/day) mills or firms. A mandatory maize flour fortification program exists for medium-scale mills (>20 MT/day) and policymakers are considering including smaller-scale millers. OBJECTIVE: We estimated the private and public costs of maize flour fortification at different scales and explored their implications for extending the mandatory fortification to include smaller-scale mills. METHODS: We used secondary data on the structure of the maize flour market and primary data on milling and fortification costs to estimate mill and regulatory costs at 3 scales of flour production: micro, small, and medium. RESULTS: For micro-, small-, and medium-size operations, respectively, operational costs of fortification were US$13, US$9, and US$7 per metric ton (MT) of maize flour, which represented 20%, 16%, and 16% of annual operating costs, and the ratio of fortification equipment cost to mill equipment costs was higher for micro-scale mills (2.7) than for small- (0.38) and medium-scale (0.54) maize mills. Governmental regulatory costs rise if smaller-scale mills are included due to the increased number of facility inspections. CONCLUSIONS: Fortification and regulatory costs increase as production scale decreases. Up-front capital costs of fortification would be daunting for micro- and small-scale mills. Medium-scale mills, which supply social protection programs, might be able to manage fortification costs and other challenges. Decision-makers should consider all costs and cost burdens, and the realities of enforcement capabilities before expanding fortification programs to include smaller-scale operations.

Plain language titleCosts of Small-scale Maize Flour Fortification in UgandaPlain language summaryA study of the costs of adding vitamins and minerals by small-scale maize flour millers in Uganda was undertaken to understand if it would be commercially beneficial from a business and operations perspective for them to do so, and if requiring them to do so would impose additional cost burdens on government to ensure that fortification standards were met.Why was the study done?Maize flour is consumed by the majority of Uganda's population, especially the rural poor. If the flour were fortified, it would reduce vitamin and mineral deficiencies among those at risk. The most important constraint to market-wide fortification is the presence of many small-scale mills or firms that neither have the resources nor the technology to adopt and sustain the fortification process. To date, no study has been done to calculate the costs that small-scale mills would have to face to fortify flour, or what the cost implications for government would be for including smaller-scale mills in a national fortification program, including the costs of enforcing regulations.What did the researchers do?The researchers interviewed millers of several scales of operation to collect cost information on their operations and interviewed representatives of government regulatory bodies to estimate the costs of testing maize flour to ensure compliance with regulations. Researchers estimated the cost to the mills of adding fortification to their business models, and the impacts on the government costs (eg, testing additional samples, etc.) of including smaller-scale mills in the fortification program.What did the researchers find?The researchers looked at 3 different types of mills based on their capacity to mill maize flour­micro-scale firms milled less than 5 metric tons (MT) a day, small-scale firms milled 5 to 20 MT per day, and medium-scale firms milled over 20 MT a day. For micro-, small-, and medium-size firms, respectively, fortification increased operational costs by US$13, US$9, and US$7 per MT of maize flour, which represented 20%, 16%, and 16% of annual operating costs. Similarly, governmental regulatory costs rose if smaller-scale mills were included because of the increased number of facility inspections required since the current legislation requires mandatory annual inspections.What do the findings mean?Fortification and regulatory costs increase as the scale of production by the millers decreases. If fortification by small- and micro-scale mills were made mandatory, up-front costs of fortification equipment and materials would be daunting for micro- and small-scale millers. Ugandan medium-scale millers might manage fortification costs and other challenges, but only if the social protection programs they supplied were of sufficient volume and regularity.

Modeling food fortification contributions to micronutrient requirements in Malawi using Household Consumption and Expenditure Surveys.

Large-scale food fortification may be a cost-effective intervention to increase micronutrient supplies in the food system when implemented under appropriate conditions, yet it is unclear if current strategies can equitably benefit populations with the greatest micronutrient needs. This study developed a mathematical modeling framework for comparing fortification scenarios across different contexts. It was applied to model the potential contributions of three fortification vehicles (oil, sugar, and wheat flour) toward meeting dietary micronutrient requirements in Malawi through secondary data analyses of a Household Consumption and Expenditure Survey. We estimated fortification vehicle coverage, micronutrient density of the diet, and apparent intake of nonpregnant, nonlactating women for nine different micronutrients, under three food fortification scenarios and stratified by subpopulations across seasons. Oil and sugar had high coverage and apparent consumption that, when combined, were predicted to improve the vitamin A adequacy of the diet. Wheat flour contributed little to estimated dietary micronutrient supplies due to low apparent consumption. Potential contributions of all fortification vehicles were low in rural populations of the lowest socioeconomic position. While the model predicted large-scale food fortification would contribute to reducing vitamin A inadequacies, other interventions are necessary to meet other micronutrient requirements, especially for the rural poor.

Global regulatory framework for production and marketing of crops biofortified with vitamins and minerals.

Biofortification of crops is being introduced in several countries as a strategy to reduce micronutrient deficiencies. Biofortified products, with increased contents of micronutrients, are currently produced by conventional plant breeding, genetic modification, or nutrient-enhanced fertilization. Corn, rice, wheat, beans, pearl millet, sweet potato, and cassava have been biofortified with increased contents of provitamin A carotenoids, iron, or zinc. However, regulatory considerations are rare or nonexistent. The objective of this paper is to review the regulatory framework for production and marketing of biofortified crops in countries that have adopted this strategy. The information was identified using Internet search engines and websites of health and nutrition organizations and nongovernmental organizations and by consulting scientists and government authorities. Thus far, biofortified products introduced in Latin America, Africa, and Asia have been produced only by conventional breeding. Cultivars using other techniques are still under testing. The production and marketing of these products have been conducted without regulatory framework and under limited government control or regulatory guidance. Nevertheless, some countries have integrated biofortified crops into their nutrition agendas. Although improvements by conventional breeding have not been subject to regulations, when biofortification becomes expanded by including other techniques, an appropriate regulatory framework will be necessary.

Fortification and health: challenges and opportunities.

Fortification is the process of adding nutrients or non-nutrient bioactive components to edible products (e.g., food, food constituents, or supplements). Fortification can be used to correct or prevent widespread nutrient intake shortfalls and associated deficiencies, to balance the total nutrient profile of a diet, to restore nutrients lost in processing, or to appeal to consumers looking to supplement their diet. Food fortification could be considered as a public health strategy to enhance nutrient intakes of a population. Over the past century, fortification has been effective at reducing the risk of nutrient deficiency diseases such as beriberi, goiter, pellagra, and rickets. However, the world today is very different from when fortification emerged in the 1920s. Although early fortification programs were designed to eliminate deficiency diseases, current fortification programs are based on low dietary intakes rather than a diagnosable condition. Moving forward, we must be diligent in our approach to achieving effective and responsible fortification practices and policies, including responsible marketing of fortified products. Fortification must be applied prudently, its effects monitored diligently, and the public informed effectively about its benefits through consumer education efforts. Clear lines of authority for establishing fortification guidelines should be developed and should take into account changing population demographics, changes in the food supply, and advances in technology. This article is a summary of a symposium presented at the ASN Scientific Sessions and Annual Meeting at Experimental Biology 2014 on current issues involving fortification focusing primarily on the United States and Canada and recommendations for the development of responsible fortification practices to ensure their safety and effectiveness.

Predicted efficacy of the Palestinian wheat flour fortification programme: complementary analysis of biochemical and dietary data.

OBJECTIVE: To utilize complementary biochemical and dietary data collected before the initiation of national flour fortification to (i) identify micronutrient insufficiencies or deficiencies and dietary inadequacies in Palestinian women and children in vulnerable communities and (ii) assess the suitability of the current wheat flour fortification formula. DESIGN: Quantitative dietary intake questionnaires were administered and fasting venous blood samples collected in randomly selected households in Gaza City and Hebron. The impact of fortification was simulated by estimating the additional micronutrient content of fortified wheat flour. SETTING: Households in Gaza City and Hebron that were not receiving food aid from social programmes. SUBJECTS: Non-pregnant women (18-49 years) and children aged 36-83 months. RESULTS: The micronutrients with highest prevalence of insufficiency were vitamin D in women (84-97 % with serum 25-hydroxyvitamin D <50 nmol/l) and vitamin B12 in women and children (43-82 % with serum B12 <221 pmol/l). Deficiencies of vitamin A, Fe and Zn were also of public health concern. Current levels of wheat flour fortificants were predicted to improve, but not eliminate, micronutrient intake inadequacies. Modification of fortificant concentrations of vitamin D, thiamin, vitamin B12, Zn and folic acid may be indicated. CONCLUSIONS: Micronutrient insufficiencies or deficiencies and intake inadequacies were prevalent based on either biochemical or dietary intake criteria. Adjustments to the current fortification formula for wheat flour are necessary to better meet the nutrient needs of Palestinian women and children.

Effectiveness evaluation of the food fortification program of Costa Rica: impact on anemia prevalence and hemoglobin concentrations in women and children.

BACKGROUND: Food fortification is one approach for addressing anemia, but information on program effectiveness is limited. OBJECTIVE: We evaluated the impact of Costa Rica's fortification program on anemia in women aged 15-45 y and children aged 1-7 y. DESIGN: Reduced iron, an ineffective fortificant, was replaced by ferrous fumarate in wheat flour in 2002, and ferrous bisglycinate was added to maize flour in 1999 and to liquid and powdered milk in 2001. We used a one-group pretest-posttest design and national survey data from 1996 (baseline; 910 women, 965 children) and 2008-2009 (endline; 863 women, 403 children) to assess changes in iron deficiency (children only) and anemia. Data were also available for sentinel sites (1 urban, 1 rural) for 1999-2000 (405 women, 404 children) and 2008-2009 (474 women, 195 children), including 24-h recall data in children. Monitoring of fortification levels was routine. RESULTS: Foods were fortified as mandated. Fortification provided about one-half the estimated average requirement for iron in children, mostly and equally through wheat flour and milk. Anemia was reduced in children and women in national and sentinel site comparisons. At the national level, anemia declined in children from 19.3% (95% CI: 16.8%, 21.8%) to 4.0% (95% CI: 2.1%, 5.9%) and in women from 18.4% (95% CI: 15.8%, 20.9%) to 10.2% (95% CI: 8.2%, 12.2%). In children, iron deficiency declined from 26.9% (95% CI: 21.1%, 32.7%) to 6.8% (95% CI: 4.2%, 9.3%), and iron deficiency anemia, which was 6.2% (95% CI: 3.0%, 9.3%) at baseline, could no longer be detected at the endline. CONCLUSIONS: A plausible impact pathway suggests that fortification improved iron status and reduced anemia. Although unlikely in the Costa Rican context, other explanations cannot be excluded in a pre/post comparison.

Model for estimating nutrient addition contents to staple foods fortified simultaneously: Mexico and Kampala data.

The objective of this work was to present a generic model for estimating fortification contents when several food vehicles are being considered simultaneously. It is based on approximating the magnitude of the nutritional inadequacy of the population (nutrient gap), the optimal use of the combination of food vehicles (fortifiable food energy, FFE), and the upper intake level to decrease the possibility that individuals with the highest combined intake of all food vehicles will exceed it. The model is intended to be used when only per capita food and micronutrient intake information, not detailed food intake data, are available. Food consumption survey data from Mexico and Kampala (Uganda) were analyzed for adult women, assuming that their intake may be similar to general per capita values. General adjustment factors for estimating the lowest and highest FFE and micronutrient intake for satisfying the requirements of other family members were calculated. These factors were used to estimate the additional effective content and the maximum allowable content, and then the recommended nutrient contents at the consumers' level were chosen on the basis of technological compatibility and cost. The method should be used in other contexts to test its validity as well as its application to nonstaple foods.

Legislative frameworks for corn flour and maize meal fortification.

Corn flour and maize meal fortification can benefit the consumer when the added nutrient contents are in amounts appropriate to address nutrient gaps. Legislative instruments (standards and regulations) are needed to provide guidance to the producers and food control authorities. We reviewed a number of national standards and regulations of fortified corn flour and maize meal and identified constraints; contrary to current belief, the practice of using minimum contents or ranges of nutrients has caused confusion, misinterpretation, and conflict, and should therefore be abandoned. On the basis of the findings, a model of fortification legislation is proposed, in which the additional content and the expected average nutrient content in a final product are recommended as the main parameters for quality control and enforcement. For labeling, the average content, or one adjusted to the expected content of the product at the market, can be applied. Variation in micronutrient contents should still be checked to ensure homogeneity but with adherence to clear procedures of sampling and testing, which should be part of the standards and regulations.

The importance of using food and nutrient intake data to identify appropriate vehicles and estimate potential benefits of food fortification in Uganda.

BACKGROUND: Concern over micronutrient inadequacies in Uganda has prompted the introduction of mass fortification. OBJECTIVE: To use food intake to determine nutrient inadequacies in children aged 24 to 59 months and nonpregnant women of reproductive age, and to model the adequacy of mass fortification. METHODS: Data were collected by the 24-hour recall method in three regions. Usual nutrient intakes were calculated by adjusting actual intake distribution for the intraindividual variance. The impact of fortification on intake adequacy was simulated. RESULTS: The nutrients with the highest prevalence of inadequate intake across regions were vitamin A (30% to 99%), vitamin B12 (32% to 100%), iron (55% to 89%), zinc (18% to 82%), and calcium (84% to 100%). According to simulations, fortification of vegetable oil and sugar with vitamin A would reduce the prevalence of vitamin A inadequacy in the Western and Northern regions; in Kampala it would eliminate vitamin A inadequacy but would cause 2% to 48% of children to exceed the Tolerable Upper Intake Level (UL). The proposed fortification of wheat flour would reduce the prevalence of inadequate intakes of thiamine, riboflavin, folate, and niacin in Kampala, but would have little impact in the other two regions due to low flour consumption. CONCLUSIONS: Micronutrient fortification of vegetable oil and sugar in all regions and of wheat flour in Kampala would reduce the prevalence of micronutrient inadequacies. However, the wheat flour formulation should be modified to better meet requirements, and the vitamin A content in sugar should be reduced to minimize the risk of high intakes. Maize flour may be suitable for targeted fortification, but prior consolidation of the industry would be required for maize flour to become a good vehicle for mass fortification.

Measurement of food consumption to inform food fortification and other nutrition programs: an introduction to methods and their application.

BACKGROUND: Information on dietary intake is essential for the assessment, planning, monitoring, and evaluation of nutritional interventions. A number of methods are available, each with unique strengths and weaknesses. Dietary intake records, 24-hour recalls, and Food Frequency Questionnaires (FFQs) determine food consumption and nutrient intakes of populations based on individual assessment; few countries have such data at national or regional levels. Food and Agriculture Organization (FAO) Food Balance Sheets (FBS) and food industry data, available in most countries, permit calculations of per capita food consumption but do not provide data on individual consumption. Household Consumption and Expenditures Surveys (HCES) are available for most countries and provide data that can be used to calculate consumption of fortification vehicles and to estimate additional intakes of micronutrients delivered through them to specific population groups. OBJECTIVE: To introduce the reader to the set of papers included in this Supplement reviewing methods and experience with HCES to inform nutrition, and specifically food fortification programs. METHODS: The Monitoring, Assessment, and Data (MAD) working group and colleagues critically reviewed experiences in estimating dietary intakes,focusing on the use of secondary analysis of HCES. RESULTS: HCES predict coverage of the population that consumes a fortification vehicle and consumed amounts of fortification vehicles. HCES allow comparisons of different population strata and may also approximate micronutrient adequacy, based on nutrient density, at the household level. CONCLUSIONS: HCES are useful to inform food fortification and other nutrition programs for planning interventions, but further work is necessary. Currently, combined use of traditional dietary surveys is needed for assessment and for program monitoring and evaluation.

Methods of using household consumption and expenditures survey (HCES) data to estimate the potential nutritional impact of fortified staple foods.

BACKGROUND: Micronutrient malnutrition, caused largely by inadequate dietary intake, is a global public health problem that adversely affects health, child growth and development, work capacity, and quality of life. Mass fortification of widely consumed edible products has the potential to increase micronutrient intakes and thus alleviate some nutritional deficiencies. Although individual-level data about food consumption patterns are ideal for informing the design of food fortification programs, they are often unavailable. Household Consumption and Expenditures Surveys (HCES) are nationally representative cross-sectional surveys conducted over a 12-month period every 2 to 5 years, primarily to characterize household expenditures. OBJECTIVE: We describe how expenditure data from HCES can serve as a proxy for household food consumption and thus aid in choosing which foods to fortify and in determining how much of a micronutrient to add to that food. METHODS: We describe methods of using HCES data to characterize apparent food consumption patterns among different strata within a population. RESULTS: There are several limitations of using HCES data to describe apparent food consumption. HCES do not directly capture information about true food intake, but rather describe food expenditures. We assume that purchased foods are not shared with guests, wasted, fed to animals, gifted, or stockpiled for later use. We also assume that foods are allocated within each household based on energy needs. CONCLUSIONS: Despite the limitations of using HCES data to estimate apparent food consumption, the dearth of individual-level data about food intake renders HCES data useful in designing food fortification programs.

Validation of dietary applications of Household Consumption and Expenditures Surveys (HCES) against a 24-hour recall method in Uganda.

BACKGROUND: The benefits of food fortification depend on the proportion of the population that uses the fortified food (coverage), the amount of the food being consumed, and the additional content of micronutrients in the food. Coverage and amounts consumed can be determined by 24-hour recall or Food Frequency Questionnaires (FFQs). However, these methods are rarely applied. Secondary analysis of data from Household Consumption and Expenditures Surveys (HCES) can be used for these purposes; however, such data analysis has not been validated. OBJECTIVE: To compare the results of HCES and 24-hour recall for estimating the consumption profile of potential fortification vehicles in Uganda. METHODS: Food intake estimates for 24- to 59-month-old children and 15- to 49-year-old women derived from a one-day 24-hour recall carried out in Uganda (Kampala, North, and Southwest) were compared with data from two HCES (2006, nationwide, and 2008, coupled with the 24-hour recall). The analyzed foods were vegetable oil, sugar, wheat flour, maize flour, and rice. RESULTS: Food consumption estimates calculated from HCES may be less accurate than estimates derived by 24-hour recall. Nevertheless, the HCES results are sensitive enough to differentiate consumption patterns among population strata. In Uganda, HCES predicted proportion of the population that consumes the foods, and approximated intakes of main food vehicles by the "observed" consumers (those who reported using the foods), although estimates for the latter were lower for wheat flour and rice. CONCLUSIONS: HCES data offer the basic information needed to provide a rationale for, and help design, food fortification programs. Individual intake surveys are still needed, however, to assess intrahousehold use of foods.

Nutritional interpretation of folic acid interventions.

Folate is an essential micronutrient, and its nutritional inadequacy is widespread; hence, programs to increase its intake are necessary. However, many concerns about possible adverse effects due to excesses have been raised. Serum folate levels are directly correlated with intake and, when low, are associated with neural tube defects (NTD), high blood homocysteine levels, and megaloblastic anemia. Serum folate cutoff points have been identified for each abnormality, and all can be associated with intakes related to the current recommended dietary parameters. Likewise, high intakes that overwhelm the physiological capacity to process folic acid into biologically active folate derivatives are near the recommended tolerable upper intake level. Although we do not know with certainty the minimum efficacious dose that prevents all folate-dependent NTD, it may actually be much lower than the current recommendation, especially when provided through food fortification; supplemental intakes around 100 microg/day appear to be appropriate.

Establishing safe and potentially efficacious fortification contents for folic acid and vitamin B12.

Determining the micronutrient contents infortified foods depends not only on the health goal (additional intake to complement the diet), but also on ensuring that fortification does not raise micronutrient intakes beyond the Tolerable Upper Intake Level (UL), i.e., the safe limit. Technological incompatibility and cost may also restrict the fortification contents. For folic acid, the limiting factor is safety, while for vitamin B12, it is cost. However, adequate fortification contents that are both safe and efficacious can be estimated for both nutrients. In order to obtain the maximum benefit from the fortification programs, three different formulas responding to three categories of consumption, as specified by the median and 95th percentile of consumption, are proposed. The model presented is based on the estimation of a Feasible Fortification Level (FFL), which then is used to determine the average, minimum, and maximum contents of the nutrients during production, taking into consideration the acceptable variation of the fortification process. Finally, the regulatory parameters, which support standards and enforcement, are calculated by reducing the proportion of the nutrient that is degraded during the usual marketing process of the fortified food. It is expected that this model will establish a common standard for food fortification, and improve the reliability and enforcement procedures of these programs. The model was applied to flours as vehicles for folic acid in the United States, Guatemala, and Chile. Analysis of the data revealed that, with the exception of Chile, where wheat flour consumption is very high and probably within a narrow range, supplementation with folic acid is still needed to cover individuals at the low end of consumption. This is especially true when the difference in flour consumption is too wide, as in the case of Guatemala, where the proportional difference between consumption at the 95th percentile of the nonpoor group is as high as 100 times the consumption at the 5th percentile of the extremely poor group. Adoption of fortification content for staple foods near the safe limit brings together the need of restricting the voluntary addition of the specific nutrient to other foods and to dietary supplements.

Wheat flour fortification is unlikely to benefit the neediest in Guatemala.

The potential impact of wheat flour fortification with iron and folic acid was assessed using data about food purchases from the nationally representative 2000 Guatemalan Living Standards Measurement Survey. Of 7265 households, 35% were indigenous and 57% rural; 11% were extremely poor, 35% were poor, and 54% were nonpoor. The percentage of households that purchased wheat flour, sweet bread, French rolls, and sliced bread in the previous 15 d was 10, 88, 59, and 11%, respectively. The median amount of fortified wheat flour equivalents in purchased foods was 50 g/d per adult equivalent; fortified wheat flour equivalents were 7, 25, and 110 g/d for the poverty groups, 16 g/d in indigenous households and 24 g/d in rural households. Wheat flour fortification contributed 2.3 mg/d of iron and 90 microg/d of folic acid per adult equivalent. Assuming 5% bioavailability, wheat flour fortification provided 2% of the recommended dietary allowance (RDA) and 6% of estimated average requirement (EAR) iron levels for women of reproductive age; values were 1, 3, and 12% of EAR levels for the poverty groups, respectively. Wheat flour fortification met 26% of folic acid RDA and 33% of EAR levels for women; values were 5, 16, and 71% of EAR levels for the poverty groups, respectively. In conclusion, the impact of fortification is likely to be substantial for folate status in nonpoor and urban women but limited in the case of iron status among all social groups. The poorest, rural, indigenous populations who suffer the highest burden of nutritional deficiencies likely benefit least from wheat flour fortification.

Food fortification to reduce vitamin A deficiency: International Vitamin A Consultative Group recommendations.

In developed countries, food fortification has proven an effective and low-cost way to increase the micronutrient supply and reduce the consequences of micronutrient deficiencies. It has been rarely used in the developing world, but general conclusions can be drawn. The biological efficacy, but not the effectiveness, of fortifying oil and hydrogenated oil products as well as cereal flours and meals with vitamin A has been shown. Sugar has been fortified with vitamin A in Central American countries for years, and biological efficacy and program effectiveness are well established. Efficacy of fortifying monosodium glutamate with vitamin A was demonstrated but a program has not been established. Fortification with vitamin A in the developing world should satisfy certain elements for success. a) A potential food matrix (a food regularly consumed, produced by a few centralized factories, without sensorial changes compared with the nonfortified equivalent, and nutrient remains bioavailable and in a sufficient amount) is required. b) Fortified foods should provide at least 15% of the recommended daily intakes for the target group (e.g., individuals consuming the lowest amount of the fortified food). c) Voluntary fortification of processed foods should be regulated to prevent excessive consumption of vitamin A. d) Neighboring countries should harmonize technical standards, facilitate compliance and minimize conflicts over global trade laws. e) A practical monitoring system should be instituted. f) Social marketing activities should be permanent and aimed at industry, government and consumers. g) Food fortification should be combined with other strategies (e.g., supplementation) to reach those not adequately covered by fortification alone. Infants and small children, whose dietary habits differ from those of adults, require special attention. Fortification of food commodities is a very attractive and economic way to prevent and control vitamin A deficiency. Effective food fortification might make supplementation of postpartum women and older children unnecessary.