4. Guide to standard development: four-step framework
The lessons learned from Bangladesh, India and Timor-Leste can be summarized as the four-step framework described in Figure 7. The process should be iterative, starting with a data collection phase that aims to define the nutritional goals of the fortification programme and identify the key micronutrients to be used and at what levels. It should be led by a national technical committee with a view to develop the draft standards through continuous consultation with relevant ministries and subject experts. The endorsement and subsequent gazetting of the standard should be accompanied by an operationalization plan to ensure that relevant stakeholders have the capacity to enforce and monitor that fortified foods meet the standard at all times.
Figure 7: Four-step framework for the fortification standard development process
Before a rice standard is developed, the staple needs to be identified as a vehicle to support and complement ongoing strategies to address micronutrient deficiencies in the population. A rice fortification standard is developed in one of two scenarios: either because one doesn’t already exist, or because an existing standard needs to be updated to meet national, regional and international guidelines and recommendations. Updating an existing fortified rice standard should consider the need for updating the set of micronutrients and/or their levels , the relevance of the standard in terms of fortification of other staple foods, and the potential need to expand the scope of the standard (e.g., to include labelling, testing requirement, etc.).
As illustrated in Figure 8, regardless of whether the standard is being developed anew or being updated, it should be driven by available national data or use supporting evidence from available national, regional and international data, resources and guidelines.
Figure 8: Drafting decision tree
Collecting data to define nutritional gaps and goals
The decision to implement a rice fortification programme requires documented evidence that the micronutrient content of the diet is insufficient, that micronutrient deficiencies are widespread and/or that fortification will result in a health benefit. This will confirm the need and provide the rationale for a fortification programme.
The first step in the process consists of collecting food intake data, supported by ancillary information such as biochemical data on nutritional status of the population. This information is necessary to justify the programme, to make an informed judgement about the types and amounts of specific nutrients to include, and to understand which foods would make suitable vehicles for fortification. Given the long-term effort and investment required to implement and sustain appropriate fortification programmes, this initial investment in the collection of adequate food intake data should include:
- Biochemical/chemical data on nutritional status (e.g., the scale and severity of specific nutrient deficiencies in different population groups);
- Data on dietary patterns (e.g., the composition of the usual diet); and
- Detailed information on dietary intakes of micronutrients of interest (e.g., the distribution of usual intakes of specific micronutrients in a population).
Data sources should include micronutrient surveys, health and nutrition surveys (undertaken every four years in some countries), household consumption and expenditure surveys, etc.
Availability of recent accurate data may be a bottleneck at this early and important step. As shown in Figure 7, in the absence of quality data, several strategies can enable the collection and triangulation of as much data as possible.
In addition to data collection, it is important at this initial stage to collect existing global and regional evidence on the impact, effectiveness and safety of the food selected for fortification to reassure those who may initially be sceptical of the proposed intervention.
Drafting the standards through a consultative and iterative approach
When the data collection phase is complete, a consultative process needs to be set up under the auspices of a national technical committee to start drafting the rice fortification standard. At this stage it is important to leverage existing expertise of national and international food safety authorities, bureaux of standards, scientific panels and technical committees. This will ensure that the standards built are technically sound.
The selection of micronutrients to be included into the formulation should consider their stability in rice, potential organoleptic impacts of a given micronutrient (e.g., impact on taste or smell), price, and the extent to which the micronutrientis already being used in other fortification and/or supplementation interventions in the country.
This process should be iterative with recurring technical consultations to build consensus and ensure that the draft standard is technically and operationally sound. The successful experiences of setting rice fortification standards in Asia show how crucial this approach has been to achieving technical consensus among a wide variety and diversity of stakeholders involved in the decision making process.
From an operational standpoint, it is important to adopt a cross-sectoral consultation approach by bringing in the practical expertise of additional partners beyond the scientific community. External partners, and in particular the private sector, should be invited to take part in the process to provide expertise and insights into the discussions and encourage the operational viability of the standards developed. These should include premix manufactures, fortified rice kernel producers, equipment manufacturers, rice millers, etc.
Adoption and publication of the standard
In the case of Bangladesh and Timor-Leste, the process of developing new standards from scratch took between 12 and 18 months. In India, the draft standards were published in the public domain for a specified duration and all comments were then reviewed by the national scientific panel and modifications were made as necessary. Publishing the standard in the national registry is the last step in the process; it provides the necessary regulatory framework for the standards to be adopted and operationalized and enables implementation and monitoring.
Operationalizing the standard
Implementation of the new or updated standard will require some time to allow for preparation by all parties in the value chain. These are many and varied, including food manufacturers, suppliers of fortificants, quality control and testing laboratories, and distributors and retailers. Preparations include production and procurement of inputs (fortificants/premix), industrial trials, staff training, and capacity building to enable monitoring and tracking of implementation.
In Timor-Leste, a road map to implementation of the rice fortification standard was developed in three stages over three years. It was designed to facilitate the gradual adoption of the new standard, increasing the percentage of rice to be fortified progressively, from 25 percent in year one to a targeted 90 percent in year three for local rice, and from 50 percent in year one to 100 percent in year three for imported rice. This enables businesses to plan and adapt their processes and defray investment costs over a longer period.
A phased approach to the implementation of standards offers the opportunity to gradually train and build capacity of monitoring officers and laboratory technicians throughout the country to test and verify the quality and quantity of nutrients and ensure they meet the regulatory standards.
Developing a rice fortification standard should not be seen as a one-off project but rather as an ongoing activity that requires consistent monitoring and adapting to shifting trends, new scientific evidence and ever-changing economic and consumption patterns. In Bangladesh, the rice fortification standard was revised in 2022, seven years after it was initially published, to adopt new methods of testing.
