Challenges in translating scientific evidence into mandatory food fortification policy: an antipodean case study of the folate- neural tube defect relationship

Objective: To identify challenges in translating scientific evidence of a  nutrient and health relationship into mandatory food fortification policy.
Design: A case study approach was used in which available evidence  associated with the folate–neural tube defect relationship was reviewed against the Australia New Zealand Food Regulation Ministerial Council's Policy Guideline for mandatory food fortification. Results: Three particular challenges were identified. The first is knowing when and how to act in the face of scientific uncertainty. The second is knowing how to address the special needs of at-risk individuals without compromising the health and safety of the population as a whole. The third is to ensure that a policy is sufficiently monitored and evaluated. Conclusions: Despite the availability of compelling evidence of a relationship between a particular nutrient and a health outcome, a definitive policy response may not be apparent.  Judgement and interpretation inevitably play significant roles in influencing whether and how authorities translate scientific evidence into mandatory food fortification policy. In relation to the case study, it would be prudent to undertake a risk–benefit analysis of policy alternatives and to implement nutrition education activities to promote folic acid supplement use among the target group. Should mandatory folate fortification be implemented,  comprehensive monitoring and evaluation of this policy will be essential to know that it is implemented as planned and does more good than harm. In relation to mandatory food fortification policy-making around the world,  ongoing national nutrition surveys are required to complement national policy guidelines.

Evalutaion of the implementation of the folate-neural tube defect health claim and its impact on the availability of folate-fortified food in Australia

Objective: To evaluate the implementation of the folate-neural tube defect (NTD) health claim and its impact on the availability of folate-fortifed food in Australia.

Methods: During late 2005, a survey was conducted in 16 supermarkets across all Australian capital cities to identify the use of the folate-NTD health claim on the labels of the 128 food products listed in food standard 1.1A.2: 'Transitional standard - Health claims' and the number of products fortifed with folic acid.

Results: Seventy-nine per cent of existing listed food products were found and two of these were implementing the folate-NTD health claim. Forty-four per cent of these listed products, previously fortifed with folic acid, were no longer fortifed. One hundred and seventeen generally available food products were fortifed with folic acid, predominantly breakfast cereals (73%). Twenty-seven per cent of these folate-fortifed products were listed in the transitional standard.

Conclusions: The health claim was not used widely to inform women of child-bearing age of the importance of periconceptional folate intake. The increased availability of folate-fortifed products generally has occurred independently of the health claim. Defciencies in the verifcation system of the tested regulatory framework are identifed. The voluntary regulatory provisions for both folate fortifcation and the use of the health claim diminished the States' infuence over their implementation of public health tools.

Assessing the case for mandatory folate fortification : policy-making in the face of scientific uncertainties

This paper presents the view that policymakers face scientific uncertainties in assessing the case for mandatory folate fortification as a policy response to epidemiological evidence of the relationship between folate and neural tube defects. Moreover, the resolution of these uncertainties is confounded by the under-resourced state of nutrition information systems in Australia and New Zealand. The uncertainties relate to potential risks and benefits associated with the intervention for the target group and the population in general. These risks and benefits reflect the mismatch between evidence and policy that arises when addressing a presumed genetic abnormality in at-risk individuals with an intervention that is population-wide in its scope. There is an urgent need to conduct ongoing national nutrition surveys and monitor and evaluate policy interventions to strengthen the capacity of nutrition information systems to inform decision-making for this current, and future, public health nutrition policy.

Assessment of three levels of folic acid on serum folate and plasma homocysteine: a randomised placebo-controlled double-blind dietary intervention trial.

Objective: To determine the minimum effective dose of folic acid required to appreciably increase serum folate and to produce a significant reduction in plasma total homocysteine (tHcy).

Design: Double-blind, randomised placebo-controlled intervention trial.

Setting: Community-based project in a New Zealand city.

Subjects: Seventy free living men and women with tHcy10 µmol/l. Mean age (range) was 58 (29-90) y.

Interventions: Daily consumption over 4 weeks of 20 g breakfast cereal either unfortified (placebo) or fortified with 100, 200 or 300 µg folic acid. Dietary intake was determined by weighed diet records and consumption of commercially fortified products was avoided.

Main outcome measures: Plasma tHcy and serum folate concentrations.

Results: Average serum folate concentrations (95% CI) increased significantly in the treatment groups relative to the control group by 28(9-51)%, 60(37-87)% and 79(51-114)% for supplementation with 100, 200 and 300 µg folic acid, respectively. A reduction in tHcy was observed, being 16(8-22)%, 12(4-18)% and 17(9-24)% in the three treatment groups, respectively.

Conclusions: A regular intake of as little as 100 µg folic acid per day was sufficient to lower tHcy in persons at the upper end of the normal range for tHcy. Low-level fortification may also be appropriate for lowering the risk of neural tube defects given that, when aggregated from all sources, the total intake of folic acid may be sufficiently high to adequately improve the folate status of young women.

The challenge for the dairy industry arising from the new health claims standard: an impetus for innovation

The publication of a Preliminary Final Assessment Report on 4 April 2007 heralded another step towards the introduction of a new Health Claims Standard to be inserted into the Australia New Zealand Food Standards Code. This Health Claims Standard, once approved by the Board of Food Standards Australia New Zealand and by the Australia New Zealand Food Regulation Ministerial Council, will permit the making of certain substantiated health claims. Prior to the introduction of the new Standard, health claims have not been permitted on food labels, with the exception of claims in relation to maternal folate consumption and its positive effect in reducing the risk of foetal neural tube defects. The new Health Claims Standard as outlined in the Preliminary Final Assessment Report is likely to have a significant impact on the dairy industry. This paper seeks to analyse that impact, including threats, opportunities and challenges that the Standard poses to the dairy industry and other food suppliers.

Mandatory folate fortification - will benefits outweigh risks?

The article considers the concerns raised about the implementation of mandatory food fortification in Australia. Mandatory food fortification, the compulsory addition of nutrients to food products, is a powerful policy approach for public health nutrition. The danger in exposing every Australians to increased amounts of nutrients is discussed. Mandate folate fortification is being assessed by Food Standards Australia New Zealand due to the increased cases of neural tube defects in Australia.

Folate fortification : a case study of public health policy-making

This thesis investigates the use of scientific evidence in the process of making public health policy. A case study located within a food regulation setting is used. The aim is to test theory against this case study. The outcome is a theoretical understanding of the use of scientific evidence in the policy-making process in a food regulation setting. Food regulation can influence food composition and food labelling and thereby affect the population's dietary intake. Frequently there are contested values, beliefs, ideologies and interests among stakeholders regarding the use of food regulation as a policy instrument to effect public health outcomes. The protection of public health and safety, taking into account evidence based practice, is generally employed by food regulators as the priority objective during the policy-making process to adjudicate among the competing expectations of stakeholders. However, this policy objective has not been clearly defined and is vulnerable to interpretation and application. The process by which folate fortification policy was made in Australia, in response to epidemiological evidence of a relationship between folate intake during the periconceptional period and reduced risk of neural tube defects, was analysed as a case study of the policy-making process. The folate fortification policy created a precedent for both food fortification and subsequently health claims policy in Australia. A social constructivist method was used to analyse the case study. The method involved deconstructing the food regulatory system into three levels; decision-making process; procedural; and political environment. Data aligned with each level of analysis was collected from 22 key informant interviews, documentary sources, field notes and surveys of both a random sample of the Australian population's knowledge of folate and use of folic acid-containing supplements (n = 5422), and the implementation of folate fortified food products into stores (n = 60). The insights that emerged from each of the three levels of analysis were assessed iteratively to identify a pattern of interrelationships associated with the policy-making process within the food regulatory system. The identified pattern was interpreted against existing theory to gain a theoretical understanding of the public health policy-making process in this political setting. The central argument of this thesis extends Sabatier and Jenkins-Smith's Advocacy Coalition Framework theory to a food regulation setting. The argument is that within the contemporary political climates of neoliberalism and globalisation, a coalition between corporate interests and the values of scientists with a positivist-reductionist approach to public health research is privileged so as to invoke certain scientific evidence to, in turn, legitimise food regulation policy decisions. The theory will help to inform policy-makers about how and why the public health policy objective in a food regulation setting is interpreted and applied. This will contribute to improving policy practice intended to effect public health outcomes. It is concluded that irrespective of the quantity and quality of the scientific evidence that is being made available, scientific evidence cannot be assumed to speak for itself Policy-making is an inherently political and value-laden process and the potential for politically motivated interpretation and application of otherwise value-neutral scientific evidence can undermine the investment in its generation. From this perspective, evidence based practice, far from liberating policy-making from political influence, can itself become part of the problem rather than the solution. Nevertheless, rational evidence based practice is an ideal to strive for and a series of recommendations is proposed to help make the use of evidence in current food regulation policy processes more transparent and democratic.

Food fortification : the evidence, ethics and politics of adding nutrients to food

This research book presents a critical analysis of mandatory food fortification as a technology for protecting and promoting public health. Increasing numbers of foods fortified with novel amounts and combinations of nutrients are being introduced into the food supplies of countries around the world to raise populations’ nutrient intakes. Three topical food fortification case studies representing the different public health rationales for adding nutrients to food were assessed for their public health benefits, risks and ethical considerations: Universal salt iodisation (USI) to help prevent iodine deficiency disorders; mandatory flour fortification with folic acid (MFFFA) to help prevent neural tube defects; and mandatory milk fortification with vitamin D (MMFVD) to help prevent vitamin D deficiency. These assessments found that whereas USI performs strongly as a public health intervention, MFFFA and MMFVD are associated with more risks and less ethical justification than an alternative policy option. Food fortification can be a blunt policy response to complex policy problems. The findings highlight that the primary predictor of a mandatory food fortification policy’s benefits, risks and ethics is its ability to address the underlying cause of the policy problem. The analysis of the policy-making processes for each case study found that certain powerful actors use their influence to determine what counts as evidence in policy processes to privilege food fortification activities over alternative policy options. Policy-making frequently was notable for the low prominence it afforded ethical considerations and its lack of public engagement. Priority activities to help strengthen policy processes and outcomes are suggested.

Profiling national mandatory folic acid fortification policy around the world

Mandatory food fortification “occurs when governments legally oblige food producers to fortify particular foods or categories of foods with specified micronutrients” [1]. Because mandatory food fortification exposes everyone in the population who consumes the fortified food(s) to raised levels of the specified micronutrient, it is one of the most powerful policy instruments available to influence dietary intake and population health outcomes. Many national food regulatory authorities have established policy guidance on mandatory food fortification. From an international perspective, the Codex Alimentarius Commission (Codex) provides principles for the addition of essential nutrients to foods [2]. According to these Codex principles, mandatory food fortification with additional vitamins and minerals is recommended where there is proven public health and nutrition need (Note: these principles are under review at the time of writing).

Among vitamin B12 deficient older people, high folate levels are associated with worse cognitive function: combined data from three cohorts

Folate fortification of food aims to reduce the number of babies born with neural tube defects, but has been associated with cognitive impairment when vitamin B12 levels are deficient. Given the prevalence of low vitamin B12 levels among the elderly, and the global deployment of food fortification programs, investigation of the associations between cognitive impairment, vitamin B12, and folate are needed.

The safety of medications for the treatment of bipolar disorder during pregnancy and the peurperium

Risks associated with pharmacological treatment of bipolar disorder are heightened during reproductive events. Treatments need to be planned with the mutual agreement of both the treating physician and the patient and tailored to the needs of the individual so as to minimise risk while providing adequate treatment. Conventional treatments have all been associated with teratogeny in first trimester exposure, lithium with cardiac malformation and valproate and carbamazepine with neural tube malformations. There have been an insufficient number of first trimester exposures to the newer anticonvulsant mood stabilisers, lamotrigine and oxcarbazepine, to determine whether there is a safety advantage in switching to these agents. Increasingly, atypical antipsychotics are being suggested as useful agents for the treatment of bipolar disorder. While not known to be teratogenic, there are other reproductive safety concerns associated with these agents. Bipolar disorder patients may be prescribed antidepressants, and many of these agents are associated with a low safety risk during reproductive events, however data regarding use of these agents are currently equivocal. Adverse outcomes from inadequate pharmacological prophylaxis have been documented for both the mother and the baby. Risks and benefits need to be carefully balanced based on an accurate review of the evidence.

Modelling of porosity defects in high pressure die casting with a neural network

High Pressure Die Casting (HPDC) is a complex process that results in casting defects if configured improperly. However, finding out the optimal configuration is a non-trivial task as eliminating one of the casting defects (for example, porosity) can result in occurrence of other casting defects. The industry generally tries to eliminate the defects by trial and error which is an expensive and error -prone process. This paper aims to improve current modelling and understanding of defects formation in HPDC machines. We have conducted conventional die casting tests with a neural network model of HPDC machine and compared the obtained results with the current understanding of formation of porosity. While most of our findings correspond well to established knowledge in the field, some of our findings are in conflict with the previous studies of die casting.

Fault detection in a cold forging process through feature extraction with a neural network

This paper investigates the application of neural networks to the recognition of lubrication defects typical to an industrial cold forging process employed by fastener manufacturers. The accurate recognition of lubrication errors, such as coating not being applied properly or damaged during material handling, is very important to the quality of the final product in fastener manufacture. Lubrication errors lead to increased forging loads and premature tool failure, as well as to increased defect sorting and the re-processing of the coated rod. The lubrication coating provides a barrier between the work material and the die during the drawing operation; moreover it needs be sufficiently robust to remain on the wire during the transfer to the cold forging operation. In the cold forging operation the wire undergoes multi-stage deformation without the application of any additional lubrication. Four types of lubrication errors, typical to production of fasteners, were introduced to a set of sample rods, which were subsequently drawn under laboratory conditions. The drawing force was measured, from which a limited set of features was extracted. The neural network based model learned from these features is able to recognize all types of lubrication errors to a high accuracy. The overall accuracy of the neural network model is around 98% with almost uniform distribution of errors between all four errors and the normal condition.