Please refer to anzfa’s guide to applications and proposals for a more detailed explanation of the process on how to undertake

18. Monitoring

18.1 Monitoring and review of the impact of mandatory folic acid fortification

Monitoring and review is a fundamental component of any mandatory fortification program. The Ministerial Policy Guideline states any agreement to mandate fortification should require that it be monitored and formally reviewed to assess the effectiveness of, and continuing need for, the mandating of fortification.

Monitoring of the impact of mandatory folic acid fortification is an important risk management consideration in order to deal with the uncertainties in the data and risk assessment. As noted in the editorial note to the draft variation of the Code (see Attachment 1), this mandatory fortification requirement will be reviewed when sufficient monitoring data become available. It is intended that the review would be completed within five years from the date of implementation of a new standard.
At Draft Assessment, FSANZ provided information in relation to the components that could be considered in an overall monitoring framework for folic acid fortification.

However, the responsibility for establishing and funding a monitoring system to assess the impact of a mandatory fortification on the population extends beyond FSANZ’s responsibilities under the FSANZ Act and will require the concomitant involvement of health and regulatory agencies at a Commonwealth, State and Territory level in Australia and the New Zealand Government.

For the purposes of progressing discussion on the proposal to mandate folic acid fortification, at Draft Assessment, FSANZ adapted the draft monitoring framework prepared by the FRSC working group for mandatory fortification of nutrients and outlined the potential elements that could be considered for inclusion in a monitoring system for assessing the impact of folic acid fortification on consumers (see Attachment 12). In July 2006 FRSC endorsed the generic monitoring framework. For nutrients such as folate, where there are already voluntary permissions in the Code to fortify some food products with folic acid as well as the proposed folic acid mandatory permissions, it was recognised that the monitoring system will need to include information on the cumulative impact of both sets of regulatory decisions on consumers.
FSANZ has recently been a participant on a FRSC coordinated expert group for determining a proposed monitoring program for folic acid. This expert group first met in July 2006 and used the proposed monitoring framework from Draft Assessment as a basis for beginning discussions on a monitoring program for folic acid. The expert group will meet again in September 2006 to progress the development of the monitoring system, with the expectation that a paper on the proposed monitoring system will be presented to the October meeting of the Australia New Zealand Food Regulation Ministerial Council (ANZFRMC).
A folic acid monitoring program will also fit into a broader national food and nutrition monitoring program, which has been discussed among various Government departments over recent years.
As the main objective of a mandatory fortification program for folic acid is to reduce the incidence of NTDs, measurement of change in NTD incidence (including stillbirths and terminations) would be an essential component of any monitoring system that aims to assess the effectiveness of the fortification measure. It would also be essential to collect information on potential unintended adverse health effects of increasing folic acid intakes for the target and non target groups in the population as this is a key part of the risk management strategy for managing the scientific uncertainties. As for any monitoring system, the collection of baseline data prior to or just after the implementation of the fortification program and at some time in the future to assess changes in performance measures is essential.
In order to determine the impact of mandatory fortification on folic acid intake, it is also helpful to collect additional data on changes to the fortified food products available and their folic acid content, consumer attitudes and purchase behaviour in relation to fortified foods, actual consumer food and supplement consumption patterns and on biochemical markers of folic acid status such as folic acid and homocysteine levels in blood serum or red blood cells. Attachment 12 gives details on possible data collection methods for each of these elements of a more comprehensive monitoring system. These data collections would provide extremely valuable information on how the fortification policy has affected the whole food system. This would be particularly important if implementation of mandatory fortification did not achieve the desired end outcome of reducing the incidence of NTDs by the expected amount or if there was evidence that it was adversely affecting the population in general.

A comprehensive monitoring system should provide sufficient data to answer the question ‘why is it not working?’ and be able to identify the best intervention point for improving the system in the future to achieve a better outcome.

FSANZ recognises that the costs for establishing an ongoing monitoring system have only globally been included in the cost-benefit analysis presented elsewhere (see Section 11.2) because the inter agency discussion on the elements (and hence specific costs) to be included in such a system has yet to take place. However, the cost of a monitoring system will need to be considered by the Ministerial Council when making their final decision on the Proposal.
Preliminary costings for various elements of a monitoring system based on current estimates have been included in Attachment 12 as a basis for future discussion with key stakeholders, including the food industry as well as the government agencies involved.
As part of its ongoing work, FSANZ will contribute directly to the following elements of the monitoring system:

• 
  tracking changes in the food supply for fortified/unfortified foods in key food categories in consultation with the food industry;
  
• 
  updating the food composition databases;
  
• 
  tracking labelling changes on fortified foods;
  
• 
  tracking changes in food consumption patterns for different demographic groups in key food categories that are likely to be fortified; and
  
• 
  researching changes in consumers’ attitudes and behaviour towards fortified foods.
  

FSANZ may also be involved indirectly in other program activities.

18.2 Comments on monitoring in submissions

Numerous submissions were received in relation to the proposed monitoring program based on the Draft Assessment Report. There were a multitude of monitoring activities suggested in addition to data collection on the incidence of NTDs, including monitoring of the safety and effectiveness of the fortification program. Monitoring of food consumption data, supplement use, changes to the food supply and many aspects of health status were all noted. The need for monitoring in both Australia and New Zealand was raised.

Many submissions and comments from consultation stated that any fortification strategy must be accompanied by a well funded monitoring system, that includes the collection of baseline data and an ongoing monitoring program with recurrent funding allocated. Some stakeholders indicated support for mandatory fortification only if appropriate monitoring was in place prior to implementation The need to allocate responsibilities for different monitoring tasks was also noted.
The need for monitoring of thiamin fortification was also identified in a number of submissions. After the review of the Code (1998-2000), FSANZ made an undertaking to assess thiamin fortification in the future. The Ministerial Council has also requested this review. This monitoring would also be captured under any national food and nutrition monitoring programs.
18.2.1 Baseline data
Many submissions commented on the lack of baseline data and the need to collect baseline data to determine the current health and food related status in relation to folate prior to mandatory fortification being introduced. There are currently a lot of monitoring activities that could provide some baseline data. This includes monitoring activities conducted by FSANZ and activities conducted external to FSANZ. The baseline data FSANZ has collected and reviewed to date for this Proposal are outlined in detail in Attachments 7a and 7b to this report. FSANZ has also collated data on NTD rates, folate status and other health related data (e.g. vitamin B₁₂ deficiency) across Australia and New Zealand. These data will provide some indicators of these issues at baseline.
Data were also been collated by FSANZ on other health related factors such as cancer rates and linkages with cardiovascular disease. Cancer rates are reported by the Australian Institute of Health and Welfare every year, and have been assessed by FSANZ. Therefore, baseline data are available prior to any implementation of mandatory fortification. However, it will always be difficult to attribute any changes in cancer trends specifically to the food supply being fortified with folic acid, as there are many factors that influence the development of cancer.
National Nutrition Surveys (NNSs) are sources of data on food consumption, nutrient levels in the food supply, nutrient intakes and in some cases, supplement intakes. NNSs already conducted will provide baseline data as an indication of these parameters at the time of the survey and prior to the implementation of mandatory fortification. NNSs, as part of an ongoing food and nutrition monitoring system would continue to provide data for monitoring purposes post fortification. A rolling NNS program has been implemented in New Zealand, and a proposed monitoring system is currently being considered in Australia with the new Australian Children’s Nutrition and Physical Activity Survey which is proposed to be in the field in the first half of 2007.
FSANZ has collected folic acid concentration data for the food supply in recent years. This has been through such avenues as analysis and the collection of food label information. These data were used to compile the folic acid concentration databases for Australia and New Zealand which was used in the dietary modelling for this proposal. this database will be used to analyse results from the 2007 children’s survey,
Attachments
1. Draft variation to Australia New Zealand food standards code

2. Summary of submissions from the draft assessment report

3. Fortification policy guidelines

4. Impact of mandatory fortification in the United States

5. Current approach to increasing folate intake among women of child-bearing age

6. Potential health benefits and risks of increased folic acid intake

7a. Methodology and Results of Dietary Modelling at final assessment

7b. Methodology and Results of Dietary Modelling at draft assessment

8. Evaluation of health risk from mandatory folic acid fortification

9. Wald Model: NTD Risk according to increments of folic acid intake

10. Food Technology Report

11a. Fortification of bread with folic acid

11b. Cost benefit analysis of fortifying the food supply with folic acid

12. Development of a bi-national monitoring system to track the impact of regulatory decisions on mandatory and voluntary fortification