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

Alternative Industry Proposal

Supports the Australian Food and Grocery Council alternative folic acid fortification proposal combined with monitoring of effectiveness. Considers this will meet recommendations of AFNMU (Abraham & Webb 2001).
Recommendations

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  consult with industry on most effective mechanisms to deliver folic acid to the target population;
  
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  immediately introduce an extensive national education programme;
  
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  immediately ensure supplements are available for young women;
  
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  promote consumption of folic acid fortified bread and products;
  
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  encourage food manufacturers to fortify new products with folic acid that are consumed by the target population;
  
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  collect national baseline data on NTDs to measure reduction in NTDs as a result of government initiatives;
  
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  conduct a national nutrition survey for consumption patterns; and
  
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  revisit the mandatory fortification proposal in two years by which time government may have the benefit of research needed to justify mass medication of the population through the food chain.
  

Consultation

Considers the shortened consultation period was inadequate with a four week consultation period.
Considers issues raised in the Initial Assessment are still relevant and the following have not been adequately addressed by FSANZ:

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  the lack of consumer choice
  
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  the lack of baseline and ongoing monitoring data necessary for tracking the long term effectiveness of mandatory fortification
  
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  inconsistencies of the proposal with the Ministerial Council Policy Guidelines
  
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  the need for ongoing and wide reaching health promotion and education strategies supported by government
  
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  targeted consultation
  
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  the issue of the indigenous population apart from stating they have an increased rate of NTDs; this should be addressed before a final decision is made on mandatory fortification.
  

GWF is one of the largest plant bakers in Australian and can provide information on products or market data for the dietary modelling.

Cost Benefit Analysis (CBA)

The level of fortification in the preferred regulatory option differs from that in the CBA therefore considers the CBA is now not relevant.

GWF is willing to work with Access Economics (AE) to provide updated cost information based on the revised levels of folic acid fortification.
The proposal is using the expression ‘flour for bread-making’. The figures provided to Access Economics for the CBA will fall short of the real cost as they relate only to wheaten flour.
Issues in the CBA are:

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  the report only considers fortification of flour derived from wheat;
  
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  the report only assesses the cost of compliance for providing a minimum level of folic acid and failed to identify that the range required by the standard would require a greater level of precise machinery and computing systems. GWF is willing to work with AE to provide update cost information based on the proposed range;
  
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  the report does not include the significant proportion of non-wheat derived flour in Australia that is imported, and it is unlikely the supplier will add folic acid for Australian needs;
  
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  the report does not take into account compliance for small speciality bakeries to ensure folic acid is added to non-wheat flour;
  
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  the report did not consider that the figure of 25% used for calculating overages was for purposes of calculation, and real figures vary from mill to mill and can be up to 100% in relation to thiamine. Required overages may be even larger with folic acid;
  
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  figures for packing costs do not accurately reflect information given to AE. No attempt has been made to cost wasted packaging and its disposal;
  
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  the method adopted by AE for determining labelling costs was done on per tonne basis. Considers the only relevant way to determine this is the number of stock keeping units (SKU’s) x average cost of SKU = total cost;
  
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  it is not clear how the figures for total testing costs were estimated, and questions regarding frequency of testing necessary to meet the proposed range were not asked;
  
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  the report did not take account of the adverse impact on export markets; and
  
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  the report did not account for loss of sales for industry when consumers chose to purchase other products not containing folic acid.
  

Consistency with Ministerial Council Policy Guidelines

Considers there may not be a demonstrated significant population health need based on:

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  the level of NTD rates in Australia and New Zealand which are not high compared to international levels;
  
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  the lack of information on folate deficiency or the benefits from increased folate.
  

Mandatory fortification is noted as ‘an’ effective method, rather than ‘the most effective strategy’. Current proposal is not the most effective public health strategy to address the health problem because minimal amounts of added folic acid will be delivered to the target population, a targeted voluntary permissions programme with education and promotion will be more effective, and the indigenous population should be a specifically targeted group because of their high NTD rate.

Agrees that bread-making flour is consistent with national nutrition policies but other vehicles are also consistent e.g. milk and yoghurt, fruit and vegetable juices, breakfast cereals and other products. Combing these with some fortified breads would be more effective.
Believes that the potential for detrimental dietary excesses or imbalances of vitamins and minerals has not been adequately explored.
Estimates that to reach an intake of 400 ug folic acid, women would need to consume 10.3 slices of white bread, 11.9 slices of wholemeal bread, and 18.5 slices of grain bread. Notes Green et al 2003 states that it is impossible to fortify foods to a level that ensures women reach 400 ug folic acid per day without exposing some people to excessive amounts of folic acid.
Maintains there has not been an adequate assessment of voluntary fortification.
Data

Considers a number of the key pieces of essential data for baseline and ongoing monitoring of a fortification programme are incomplete, out-of-date or nonexistent. These include the national nutrition data for Australia and NZ, NTD statistics for both countries, nutritional status for both populations including folate and B12 status, and current national data on folic acid supplement use.

Notes limited data exists on the folate status of Australian and New Zealand populations and considers this vital to assess whether mandatory fortification is needed.

No accurate national register of NTD rates in Australia or New Zealand, and only South Australia has mandatory reporting of NTDs, and WA and Victoria are the only other states with reasonable statistics on NTD related terminations. Considers it essential that accurate data is collected at least 12 months before implementation of fortification for baseline data.

Considers the Draft Assessment does not clearly define the recommendations set out by the National Health and Medical Research Council (NHMRC) in the new Nutrient Reference Values (NRVs), which actually recommend 800 ug folic acid a day for women of child-bearing age.
If 50 % of the RDI is to be added per reference amount of food under the NRVs, then food manufacturers could double the amount of folic acid added to these foods. This will increase the folic acid in bread to above the proposed mandatory level.
Dietary Modelling

Considers the calculation of the level of folic acid in bread as proposed is not correct. Notes in the 33 breads produced by GWF the flour content varies from 26% to 65% wheaten flour with an average of 47% wheaten flour. Some grain breads contain approximately 30% wheaten flour. .

GWF provides estimates of the levels of folic acid in bread which range from 52 µg folic acid in soy and linseed to 130 µg in standard white bread. GWF also notes that intakes based on two slices of bread a day will also add variation.
Based on the thiamine experience, it is considered there could be overages over 300 ug /100 g level.
Does not agree with the calculated figures used in DAR Scenario 1 dietary modelling. Considers the average increase in folic acid amongst women of children bearing age will be between 43 and 78 ug per day, and 30% of the population will consume half this. Considers that folic acid intakes from mandatory fortification will not increase as much as proposed because of lower bread consumption in the target group than dietary modelling estimates.