Folic acid fortification decision due this month

NZORD’s submission to Food Policy team at Ministry for Primary Industries – August 2012

Food Policy Team
Ministry for Primary Industries
Wellington

This is the submission from NZORD, the New Zealand Organisation for Rare Disorders, to the Ministry for Primary Industries consultation (MPI Discussion paper 2012/02) on the future of folic acid fortification of bread in New Zealand.

Introduction:

NZORD is an umbrella organisation set up to promote improvements to primary prevention, early detection, accurate diagnosis, improved clinical care, better community support, and more research into treatment and cures for rare disorders. We have a network of 155 rare disease support groups and we work closely with different clusters of these groups and with officials, clinicians and researchers, on a variety of different health and disability issues.

On the issue of folic acid fortification we have worked closely over many years with the Coalition of Parents of Children with Spina Bifida and the Paediatric Society of New Zealand, and more recently with the newly formed support group Spina Bifida New Zealand, to assist the development of good public health policy regarding the prevention of neural tube defects. We have participated in the folic acid working group and during 2009 we made submissions to the Broadcasting Standards Authority and to the Regulations Review select committee regarding folic acid media coverage and policy.

In past years we have made submissions to various agencies’ consultations on this issue, and we refer you to these:
Our 2004 submission to the Ministry and Food Safety Authority.
Our 2009 submission to NZFSA at the time of the proposed deferral of the folic acid standard.

We ask that the specific arguments and general principles we presented in those submissions should also be considered by you in relation to this consultation, in regard to:

  • the proven public health benefits and safety of folic acid fortification
  • the manipulation of public concern by the industry in 2009
  • the legal duties held by the Minister under the Food Act in relation to the issues currently under consultation, in particular the need to protect public health.

Further comments are made on these issues below.

Summary of submission:

  • We support and strongly endorse the submission of the Paediatric society of New Zealand on this consultation, and their argument that Option 1, mandatory fortification, is the preferred option.
  • The issue is a public health issue, and it needs to be recognised that nearly all public health issues produce controversy as the need for society-wide actions produces tension with the innate wish of people to exercise personal choice.
  • Within the mix of issues to be considered is the legal consideration of a Right to Health expressed in many international instruments New Zealand is signatory to, and the corresponding duty the government has to provide policies that protect and promote that right, and in this particular case specifically referred to as an item the Minister must take into account when deciding this matter under the Food Act.
  • We acknowledge the Minister may also take into account matters such as public sentiment, but ask that the Minister take careful note of the orchestrated misinformation campaign generated by industry in 2009 to undermine the fortification standard then, which resulted in considerable public anxiety. By contrast, a much lower key campaign by those same interests this time, by the back door route of commissioned opinion pieces by scientists who oppose fortification, indicates the need for the Minister to be wary of those tactics, but also provides an opportunity to note a much lower level of public concern expressed this time around. Public response seems directly correlated to the intensity of the campaign and the level of claims made in it. Notably, some media efforts to feed the controversy this time have not generated wide concerns and the minister should take account of what appears to be a lessening of public concern as the issues has been discussed over time.
  • The effect of the 2009 decision to postpone the fortification standard, was in effect a move by government to delegate responsibility for this public health policy to the baking industry, something they said they could do and which the Minister and the Prime Minister both set expectations for.
  • The 2009 deferral and the early 2012 deferral, both focussed on an opportunity to carefully assess evidence relating to benefits and risks, and to assess how the industry has performed under the voluntary fortification regime.
  • We submit that evidence of benefit of folic acid fortification has remained clear and unequivocal over recent years as well as over recent decades, especially in relation to prevention of neural tube defects, but also in relation to newer evidence of avoidance of congenital heart defect and stroke deaths. The references we would cite for this are the same as those in the Paediatric Society’s submission and those in the Ministry’s monitoring and evaluation report (MPI Technical paper 2012/01).
  • We further submit that evidence of safety of folic acid fortification has strengthened further since 2009, to the extent that there can be no doubt that fortification is a safe option to take.
  • We submit that one of the prime considerations the Minister should have in this decision, as one of those “other matters” she may have regard to under the Food Act, is whether the voluntary fortification regime put in place and the effective delegation to industry of this public health responsibility, has been acceptably responded to by industry. We submit that the industry has failed to a significant degree to meet their promises and the expectations of government, and that this responsibility should now be taken off them and the fortification programme directed by government with monitoring by Food Safety.
  • We further submit that if the Minister wishes to maintain an element of choice for consumers to purchase non-fortified bread, she should adopt option 2, limited mandatory fortification, with a threshold worked out perhaps by bakery size to ensure that approximately 95% of bread by volume is fortified. Such a decision would provide a clear acceptance of the public health benefits while allowing some element of choice for the very small portion of the population holding strongly to that wish.

Additional comments:

  1. Issues of autonomy/choice versus public benefit.
    • There are various frameworks in public health ethics for attempting to resolve these apparent conflicts. Two prominent frameworks are described in:
      • Beauchamp T and Childress J. Principles of Biomedical Ethics, 5th Edition, Oxford University Press, Oxford, 2001
      • Bernheim R, Nieburg P, Bonnie R. Ethics and the Practice of Public Health, in Goodman et al, eds, Law in Public Health Practice, 2007, 2nd edition 110-135
      Both of these point to the need to act rather than not, in a way that seeks to balance a variety of interests, evidence, costs, benefits, rights and duties.
    • NZORD submits that all of the information and circumstances relating to this particular consultation would lead to a decision to choose Option 1, for preference, or Option 2, as a concessionary fall-back position, under either of these well established and well respected ethical frameworks.
  2. Public law obligations
    • In additional to the Minister’s duty to take into account the need for protection of public health, the Food Act also refers to NZ’s obligation under any international treaty, agreement, convention or protocol. Section 11(d) of the Act mentions these general headings prior to specific mention of the Australia-New Zealand Joint Food Standards Agreement.
    • The right to the highest attainable standard of health is enshrined in the International Covenant on Economic, Social and Cultural Rights, to which NZ is a signatory. This right places a corresponding duty on governments. Obviously in the context of this consultation that duty is not absolute but is subject to the complex interplay of benefits, risks, and other matters related to food safety and public health protection.
    • NZORD submits that in the context of these public law obligations, once the evidence of benefits and absence of risks are clear, there is a compelling responsibility on government to ensure that its decisions provides the optimum level of benefit to the population as a whole. We believe this duty of government cannot be fulfilled by delegating responsibility to industry to implement, as discussed below, especially in circumstances where industry has shown no willingness to look much beyond its own interests during the voluntary fortification regime.
  3. Industry as the implementer of public health policy
    • In 2009 the postponement of the fortification standard meant the government was effectively delegating its responsibility for this public health programme to the baking industry. NZORD accepts that there is nothing wrong in principle with such a course of action, despite it being an unusual approach for New Zealand. However the consequence of this is the need for very close scrutiny and monitoring of how the industry performs this responsibility.
    • We note that press releases from both the Minister and the Prime Minister at the time of the 2009 postponement of the folic acid standard, expressed faith in the industry to carry out this role, and also set expectations of them to perform. NZORD submits that industry have failed to perform to any reasonable level. In support of this criticism of industry’s performance we note:
      1. Industry’s promise in their press release at the time to do a targeted fortification programme and engage in a public education campaign about the benefits and need for folic acid in diet. However the Minister will be aware that at the first working group meeting which she chaired, the industry resiled from the undertaking of a public education campaign. They did not carry out any public education function in the next three years.
      2. Industry failed to disclose any information to the working group, despite requests, and despite promises they would do so, about quantities of bread by volume that were to be fortified. They provided information about fortification of one third of bread lines (bread products) but no useful data that could enable the working group to assess the effectiveness of their programme. Only with the publication of this consultation document was any information provided to MPI (page 20) that disclosed the total of all bread fortified was as low as 12.5%. This was even below the estimate made by NZORD at the first working group meeting that more effort was needed from industry to avoid fortification in the range of 15 to 20% only.
      3. The monitoring and evaluation report states at page 13 that within those lines that were fortified, industry fell “well below its stated objective” to fortify at 200mcg/100g.
      4. Allowing for the fact that industry aimed for a higher level of fortification than required by the postponed standard, the actual impact of their voluntary fortification regime has been to deliver less than 1/6th of the amount of folic acid to the population that the standard would have done.
      5. By any measure, the industry’s achievements over the past 2 to 3 years have been a substantial failure. Their programme has seriously underachieved an acceptable level of fortification by a very long way, especially as very few of the fortified breads are budget lines likely to be consumed by the highest risk populations.
      6. Where some actual measurements are possible, as in the Otago research, it shows some improvements to blood folate levels in the female child-bearing age population in NZ, but the rise in blood folate levels is far short of optimal for any programme (voluntary or mandatory) as the rise was from 26% to 59 % only. This is a significant lost opportunity and a major under-achievement.
      7. When further analysing these blood folate improvements, this change is more likely to be chiefly influenced by increased folic acid in other foods, especially breakfast cereals, as only 18% of the women surveyed had eaten bread known to be fortified.
      8. The revised figures from the working party as estimated by MPI suggest a reduction of 24 NTDs from bread fortification under the standard. By contrast the industry’s voluntary programme has likely contributed just 4 cases avoided, leaving a substantial gap of 20 cases per year missed. This can also be presented as close to 60 (avoidably) dead or seriously damaged babies since the postponement of the fortification standard, and another 20 per year at current levels, if left to industry to manage. This is a very significant harm not dealt with, and that is a very significant public policy matter and a moral hazard for government.
    • NZORD submits that the industry’s efforts have been such a dismal showing that government must take back control of the fortification programme and ensure it is implemented in an effective way, with monitoring by Food Safety.
  4. Economic issues
    • We note much was said in 2009 and on earlier occasions, about costs and timeframes to change packaging and labels, but we also note that industry made changes at very short notice in 2009 when the standard was postponed, and with no mention of those costs or time needed to adjust.
    • Any concerns expressed on these matters should be evaluated in the light of this past experience.
  5. Commentary on Option 1 versus Option 2.
    • NZORD strongly supports option 1, mandatory fortification, as the best for health outcomes for the population, but does accept the Minister may take other views and perspectives into account, including the wish for a segment of the population to retain choice. When surveyed away from the anxiety of misinformation campaigns about safety issues, this segment is very small – in the order of 2 to 7% depending on which survey is noted, as reported in Food Safety reports prior to 2009 and early this year.
    • The dilemma for government is that using the voluntary fortification mechanism for supporting choice for a small percentage of the population puts a much larger number at risk. Providing choice for bakers to decide if they will fortify their bread leaves government (and the population as a whole) without any effective way of ensuring they actually deliver the public health outcomes which are so important. In other words, government would abandon control of its policy outcome to the bakers will.
    • Additionally there may be difficulties in effective implementation and monitoring of very small bakeries.
    • Option 2, limited mandatory fortification where a threshold is set before mandatory fortification applies, provides an opportunity for the Minister to allow the choice factor, and avoid difficulties with implementation and monitoring in very small bakeries, while still delivering a substantially effective public health programme to the vast majority of the population.
    • Provided the threshold is set high enough to capture the substantial majority of all packaged breads (60% of all bread so the industry inform us), and all bread products baked by the major plant bakeries on contract for takeaway chains and the like, the total of bread fortified would be close to 90% based on industry statements to the working group about total bread production in New Zealand. If other medium sized chain bakeries such as those in major supermarkets were included in the requirements to fortify, it appears that small owner operator bakeries could be exempted from mandatory requirements (but still permitted to fortify voluntarily) and overall bread production of fortified bread could reach close to 92 to 95%.
      If the Minister is inclined to allow any option other than Option 1, mandatory fortification, NZORD strongly urges that Option 2 is then chosen with careful consideration about how the exemptions are arranged to ensure that a very high threshold of about 92 to 95% of fortification is obtained.

Thanks for the opportunity to comment. This is a challenging task for the Minister and government, but effective leadership could bring us through this with an acceptable solution that substantially meets the widest range of interests. NZORD looks forward to a positive outcome for the health of babies and other benefits to the population as a whole.

John Forman
Executive Director