Limiting axes in the strategy of fortification of wheat flour and cornmeal with iron and folic acid

Karla Lisboa Ramos. Objectives Food fortification consists of adding the essential nutrients that the population needs the most to processed foods or its ingredients during manufacturing to improve the nutritional quality of the product and benefit public health without jeopardizing health. Objective of the study was to assess the factors that limit success in the mandatory fortification of wheat flour and cornmeal with iron and folic acid. Methods the sample consisted of official documents and the Interinstitutional Commission. Documents, official texts, and interviews were analyzed. The interviews were validated by semantic analysis and a group of expert judges. The model proposed by the Guidelines on Food Fortification with Micronutrients was used for analyzing the implementation. The software ALCESTE® version 2010 treated and analyzed the data. Results The limiting axes of food fortification implementation were Regulatory Monitoring and participants’ Integrated Commitment. The highest chi-squared values indicated concern with product quality control and monitoring. Monitoring and Assessment; and Communication, Social Marketing, and Advocacy were not properly planned. Technical and operational factors limited food fortification implementation. Conclusions Also, managerial factors need to be reagreed upon according to the Social Compromise to Fight Iron-Deficiency Anemia in Brazil.

The model proposed by the Guidelines on Food Fortification with Micronutrients is an international reference for the planning and implementation of food fortification with micronutrients. It provides data on the benefits, limitations, conception, implementation, monitoring, assessment, cost-benefit relationship, and regulation, especially for developing countries (Allen, Benoist, DaryandHurrell, 2006).
In face of the importance of food fortification to minimize health problems in more vulnerable groups and the inexistence of studies on the factors that affect food fortification implementation, this study aimed to assess the factors that limited success in the Brazilian wheat flour and cornmeal fortification with iron and folic acid from 1999 to 2012.

Methods:-
The sample consisted of fifteen official documents on mandatory food fortification in Brazil published on sites of the Ministry of Health and the National Sanitary Surveillance Agency.
All representatives of the agencies (n=12) involved in food fortification planning and coordination were invited to participate. These representatives composed an Inter institutional Commission, whose mission was to implement, follow, and monitor the fortification of wheat flour, cornmeal, and their byproducts (8).A busy schedule and little familiarity with the theme prevented representatives of two agencies to participate in the individual interviews, so ten subjects were included.
The documents were searched and selected at the sites of the Ministry of Health and National Sanitary Surveillance Agency using the keywords fortification, foods, prevention, nutritional deficiency, iron, and folic acid, and by contacting the institutions to obtain documents from the physical archives. After document classification, content analysis determined the relationship between linguistic context and its joint representation (May, 2004;Cellard, 2010; Bardin, 1977).
Semi-structural interviews investigated the Inter institutionalCommission's understanding of food fortification implementation. The script of the interviews was validated by semantic analysis and a group of expert judges (Pasquali, 1998).The variables were chosen from the following documents: Micronutrient Programs: What Works and What Needs More Work? AndFortificación del azúcar con vitamina A en Centro América: experiencia y leccionesaprendidas (Fortification of sugar with vitamin A in Central America: experience and lessons learned, MOST, The USAID Micronutrient and Child Blindness Project) (Klemm, Harvey, Wainwright, FaillaceandWasantwisut, 2009).Content analysis analyzed the relationship between linguistic content and the joint representation of the interviews (Bardin, 1977).Data were collected after the subjects signed a consent form and a term authorizing the use of voice recordings for study purposes.
Compliance with the 27 items of the five stages of the Guidelines on Food Fortification with Micronutrients was assessed to verify whether the official documents included the implementation stages required by the Guidelines: a) definition and establishment of nutritional goals based on documented information; b) monitoring and assessment; c) estimates of cost-effectiveness and cost-benefit; d) communication, social marketing, and advocacy; and e) national food legislation (Allen, Benoist, DaryandHurrell, 2006).
The software AnalyseLexicale par Contexted'um Ensemble de Segments de Texte -ALCESTE® Version 2010 quantified the frequency of words and segments of the official documents and interviews, and extracted lexical and thematic meanings of the text, which facilitate global interpretation by grouping semantic roots and the formation of classes and their relationships, always taking into account the function of a word in a given text and context.Thus, the classes were defined by occurrence, co-occurrence, and textual function of the words (Camargo, 2005).The elementary context units (ECUs) -elementary representation or minimum statement in a discourseand the classes, constructed by grouping many ECUswere defined as text fragments with equal size and homogeneous vocabulary (Nascimentoand Menandro, 2006).The chi-square test measured the strength of association between words.
This study was approved by the Research Ethics Committee of the School of Health Sciences of the University of Brasilia under protocol number 127/12.
The fifteen study documents were classified as primary and public. Their analysis contemplated five dimensions indicating that: they were created jointly by the government, production sector, universities, and civil society; they were created by the managers responsible for coordinating the action in situ; they had legal, technical, and scientific nature; they discussed iron and folic acid deficiencies in mother/child dyads, their negative impacts on children's cognitive development, and the associated gestational morbidity and mortality; and they claimed that the pillars of the wheat flour and cornmeal fortification strategy were the National Food and Nutrition Policy and the Social Commitment to Fight Iron-Deficiency Anemia in Brazil.Content analysis by ALCESTE® indicated use of 98.5% of the vocabulary, 1,159 ECUs, and six classes. These classes enabled the identification of two thematic axes: Monitoring and Assessment and Food and Nutrition (Table 1). The axis Monitoring and Assessment (classes 1, 3, and 5) related the central ideas on the implementation of mandatory fortification identified by the highest chi-square values, and demonstrated concern with product quality control and follow-up.
Class 1 defined product quality control and monitoring, which aimed at sanitary inspection and oversight; technical audit; Good Manufacturing Practices manual; use of inspection guidelines; data recording for monitoring; sampling plan; easy-to-use quantitative methodology (Table 1).
Class 3 centralized and detailed aspects of production technology ( Table 1). The text fragments with the highest chisquare values demonstrated concern with the technologies that disperse and homogenize the micronutrient mix, and the impact of different compounds on the characteristics of the final product, their physical and chemical stability, and ease of dispersion and homogenization. These aspects were also considered for fortifiable corn-based products: cornmeal with iron, products for fortification, grits, flour, snacks, micro aspersion, cornflakes, corn flour, and cream corn.
The milling industry mobilized itself to minimize technology-related problems, pledging to establish partnerships with sponsor agencies and research institutes that encourage the search of a simple and viable technology that enables micro-and small milling enterprises to add iron compounds to their products.
Class 5 ratified the positive impact of folic acid fortification on the prevalence of congenital malformations, considering this the main tool for the primary prevention of congenital malformations ( Table 1).
The Food and Nutrition axis (classes 2, 4, and 6) demonstrated thatactions that promote a healthy diet are determinants in the agendas of nutritional deficiencies and mandatory fortification (Table 1).
Class 2 related to the financing, structuring, and planning of nutrition actions that aim to compose the tripartite financing of these actions in the state health care network and to provide technical assistance and institutional support to the management of food and nutrition programs and actions.
Class 4 identified nutrition-related diseases stemming from individual eating behavior or from inappropriate qualitative and/or quantitative eating habits.
Class 6 was associated with nutritional value and the concept of food security. The following ideas were also identified:appropriate and healthy diet themes; respect to cultural diversity; determinants of food and nutrition situation; access to healthy foods; sanitary responsibility and the right to information and proper food choice.
Content analysis of the interviews indicated that the corpus used approximately 98.5% of the vocabulary, analyzed 833 ECUs, and formed five classes that identified two thematic axes: Regulatory Monitoring and Integrated Commitment (Table2). Axis 1 (classes 1 and 3) focused on the internal (quality control and assurance by the industry) and external monitoring (sanitary inspection in situ) of mandatory fortification, which focused on quality control and assurance standards and legal norms for the inspection of fortified foods. Class 1 expressed the importance of using appropriate doers to add the micronutrient mix to the products and proper homogenization because addition alone does not ensure equal distribution of the mix.
Class 3 identified the importance of controlling the amount of nutrients added to the flours, especially folic acid, and monitoring by the sanitary surveillance agency given the limited physical and operational conditions. Axis 2 related to the commitment and involvement of decision makers to defend food fortification implementation. Class 2 expressed the need of political prioritization of the monitoring stage by disseminating and communicating its positive impact on the incidence of neural tube defects to the managers who make the decisions and the organized sectors of society. It equally emphasized the importance of social participation in the creation of a public health strategy and the need of reinforcing social participation by providing more incisive and ample communication. However, the text fragments obtained in the interviews revealed that the Internal monitoring (quality control/quality assurance), the impact of the evaluation and the advocacy were the items that have a negative impact on evaluation of respondents (Table3). "the predominant group of (overweight) and (obesity), (diabetes) mellitus, cardiovascular (diseases) and some neoplasms, having (as) elective host the segment of (adults) and people of (more) (advanced) (age)" 100

Discussion:-
The originality of this study lies in the identification of the thematic axes that limitedthe success of mandatory wheat flour and cornmeal fortification with iron and folic acid in Brazil. Such technical, operational, and managerial limitations were related to Monitoring and Integrated Commitment.
Although the development of universal fortification was grounded in the guidelines of the National Food and Nutrition Policy (Brasil, 1999a; Brasil, 2011)and the Social Commitment to Fight Iron-Deficiency Anemia in Brazil (Brasil, 1999a),joint analysis of official documents and interviews,and chi-square values showed that monitoring is a challenge and limits product quality control and follow-up.
Especially in this context, adequate addition and homogenization of the micronutrient mix is important as it is associated with official quality control (Brasil, 1999a;Brasil, 1999b;Brasil, 2011). These pieces of evidence may justify the findings of some studies on the impact of fortification, that is, that the iron status of the population did not change significantly in response to the type of compoundused for food fortification and its bioavailability.
The positive impact of flour fortified with iron is probably related to the standardization of fortification technologies that guarantee the quality of the final product and to a rigorous inspection of the manufacturing processes The government's agenda does not currently include the theme "nutritional deficiencies," even though interventions that prevent and control these deficiencies are inexpensive and have great impact on the health of the mother/child dyad. Some authors believe that this challenge depends on strategic advocacy actions that reach beyond the health sector (Mannar, 2006 (Allen, Benoist, DaryandHurrell, 2006, Griffiths, 2003has shown that there has been enough technical investigation based on scientific evidence to define the nutritional objectives and that fortification normalization regulated the process of implementation. However, the list of iron compounds used in food fortification listed in the Brazilian legislation needs to be reviewed and updated to allow selection of the compounds with the best bioavailability and cost (Brasil, 2002).
A mean micronutrient content and upper limit in fortified foods need to be defined for nutrient content standardization and control. Currently only the minimum content is defined, despite the mention of this need in the referrals of the regular meetings of the Inter institutional Commission (Brasil, 2009).
Regulation contributes substantially to the implementation of public health actions (1).Some authors believe that a food fortification program is not very likely to have significant impact in the absence of a national law establishing quality parameters, and emphasize that the legal environment may facilitate or delay the implementation process (PAHO, 2008;Fiedlerand Macdonald, 2009).
There is a lack of documented information about the cost-effectiveness and cost-benefit of implementing food fortification, except in a document that estimated the cost of the fortification compound, equipment, and laboratory infrastructure (Brasil, 1999c).The documents did not mention the cost of an impact study, social marketing, quality control performed by the manufacturers, and monitoring and assessment conducted by the government.
The few cost dataavailable possibly limited estimating the required investment and failed to sensitize decision makers regarding the inclusion of the theme in the government's agenda. A national fortification program needs to reassess the challenges related to the legislation, quality assurance, control systems, social marketing, and impact follow-up and assessment to make changes that improve program implementation (Wirth, Laillou, Rohner, Northrop-Clewes, Macdonaldand Moench-Pfanner, 2012).
Ineffective communication among the institutions involved, the fragile structure of the monitoring and assessment programs, the limited financial resources to conduct studies, and the somewhat ineffective leadership in the coordination of the actions and creation of priority scenarios prevent the total implementation of food fortification programs (Klemm, Harvey, Wainwright, Faillace and Wasantwisut 2009).
The World Health Organization (WHO) suggests that the countries that intend to implement universal fortification should conduct monitoring and assessment by continuously collecting data in critical points of the process to obtain the information required to identify inefficiency, take corrective measures, and redirect the program if necessary. Impact assessment, which will certify performance quality and the fulfilment of nutritional objectives, should only occur after satisfactory program implementation.If implementation is partial, it is not possible to measure fortification effectiveness (Allen, Benoist, DaryandHurrell, 2006, Griffiths, 2003.
Analysis of documents and subject discourses and comparison with the adopted model confer reliability and complementariness to the study data. Since analysis of subject discourse was consonant with the official documents and presented situations intrinsic to the work of both the Inter institutional Commission and affiliated institutions, it was possible to identify in the individual discourses the Commission's understanding of food fortification and the specific problems that limited implementation.
The study limitation is the non-inclusion of questions in the instrument that would identify the solutions suggested by the Inter institutional Commission.

Conclusions:-
Food fortification needs to be reintroduced in the agenda of micronutrient deficiencies to achieve a new agreement between signatories of the Social Commitment to Fight Iron-Deficiency Anemia in Brazil and to identify new advocacy partners that useample communication strategy,andconsider the various sectors involved and the population.
Author Karla Lisboa Ramos declares that has no conflict of interest. Author Wilma M. C. Araújo declares that has no conflict of interest. Author Rita Akutsu declares that has no conflict of interest. Ethical approval: Informed consent was obtained from all individual participants included in the study.