Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming sufficient foiic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it couid be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or . introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any hannful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposais. Once you have completed this form Email for WW White we prefer email, you can also post your submission to: Consuitation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Andrea Herron or contact person: Organisation (if applicabie): NZ Registered Dietitian Email: a Official information Act 1982 All submissions are subject to the Official Information Act and can be released (along with personal details of the submitter) under the Act. if you have specific reasons for wanting to have your submission or personal detaiis withheid, please set out your reasons in the submission. will consider those reasons when making any assessment for the release of submissions if requested under the Official information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood foiate leveis of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate leveis for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntariiy forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-a?ected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Cl Agree. Yes El Disagree. Unsure. Please explain why: I agree that many women of chiidbearing age cannot get enough folate from natural food sources. The requirement of 600ug folate daily for women of child bee?ng age (WCBA) is very dif?cult to achieve considering the food sources it is highest in (including broccoli, spinach, beans - namely black beans, lentils, pinto beans, chickpeas, blackeye peas) are foods which are not consumed by the population at large and on a daily basis (possibly unless vegetarian or vegan). Since the initiation of voluntary fortification of folic acid in sliced packaged bread since in 1996 has not met the target of 50% i can?t see continuing with a voluntary option will impact on a birth defect which is known to be reduced with adequate folatelfolic acid intake pre pregnancy and during ?rst weeks of pregnancy. NTD are preventable and we know that taking adequate amounts of folateifolic acid reduces the incidence of this occuring. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. Yes CI Disagree. Cl Unsure. Please explain why: Agree I agree that there needs to be an increase of folic acid forti?ed containing foods that are readily available to all women of childbearing age (WCBA) to reduce the number of NTD affected pregnancies with minimal impact an the rest of the population. Considerations need to be given to ensuring safe levels of felic acid, it needs to be sustainable and I think a lot of support needs to be provided to industry to help achieve this forti?cation. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE [3 Agree. El Disagree. Yes Unsure. Please explain why and provide any evidence you may have: Disagree with this option of maintaining status gun as we have a problem of NTD affected pregnancies and it wont be impacted by not making change of improving foods available with added folic acid. Health impacts - Health outcomes wont improve as statistics from NZ health survey 2014115 show most (WCBA) did not have optimal blood folate levels for the prevention of NTD-affected pregnancies. The assessment shows that there would be limited affect on reducing further NTD affected pregnancies if stay with status quo. As NTD occur in the early weeks of pregnancy, before many women know they are pregnant, increasing folic acid in everyday foods would be bene?cial to increase their folate status to help safe guard these women. As the supporting document states that only 8.7% of all women who gave birth in 2015 were dispensed folic acid supplements (however other women would have bought these over the counter). Equity As many pregnancies are unplanned and particularly amongst young women 15-24 old the discussion {eport shows this group have the lowest folate levels. The supporting document also states that folic acid supplement usage prior to pregnancy was lower in younger age grows and Pacific Island and Maori women. in line with the Treaty of Waitangi, increasing folic acid forti?ed foods will help reduce the disparity between Maori and Non Maori. Consumer choice yes agree consumer choice will be maintained at the detriment of NTD affected pregnancies. Option industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being fortified under the Code of Practice from the 2017 level of 33% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FDRTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY El Agree. El Disagree. Yes El Unsure. Piease explain why and provide any evidence you may have: I disagree with this option as I don't see that a voluntary initiative that has ?nancial implications to industry (eg especially smatt bakeries) will increase the support of this option from industry. The supporting techinicai document states that in a review of Australia?s foiic acid forti?cation, it concluded that mandatory folic acid forti?cation was more effective than pre-mandatory forti?cation considering the effectiveness and cost-effectiveness of mandatory foiic acid. It has taken since 1996 until 2017 to achieve 38% of packaged sliced bread being forti?ed. This falls well short of the new goat of 80% of packaged sliced bread being forti?ed. Health impact unless there is signi?cant uptake of voluntary foiic acid forti?cation, it wilt not impact on the number of NTD affected pregnancies. How many years will it take to reach 80%? In the mean time NTD affected pregnancies continue to accrue. if is devastating that the technical supporting doctment states that if mandatory fortification of bread-making flour had occurred in 2069 when it came into effect in Australia, it is estimated that 134 to 180 pregnancies affected by an NTD coutd have been prevented over the last ten years in New Zealand- The supporting doctsnent highlights that in the Baking Industry Research Trust annual audit of comptiance with the industry code of practice that the median foiic acid content of ati bread was below the recommended target of 200 ugItOOg. So. forti?cation needs to be regulated. Equity no improvement in reducing disparity between WCBA in NZ as they rely on industry to voluntarity fortify sliced packaged breads. Consumer Choice agree this is maintained as it is unlikely that 80% of sticed packaged bread will be fortified under a voluntary scheme. Consumer choice will continue at the detriment of future affected pregancies. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread fortified with folic acid at the bread-making stage. it would apply to all non? organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice. and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY El Agree. [3 Disagree. Yes El Unsure. Please explain why and provide any evidence you may have: Disagree with this option of fortifying all bread at the bread-making stage. lt would have a ?nancial impact on industry especially start up costs for small bakeries. There will also be a wide variation amongst bakeries of the levels of folic acid in breads. Health impacts Science modelling in the NZ Food Safety Discussion information demonstrated up to additional 270 NTD affected pregnancies could be prevented in the next 30 yrs. Equity - help reduce the disparity in NTD rates. particularly for Maori women and young Mums. Cost Effectiveness - as there are a large number of bakeries to monitor that folic acid is being added and at the correct levels, monitoring would have cost implications. However there would be savings to govemement with a reduction in the prevalence of NTD affected pregnancies. Consumer Choice - Fortifying all non-organic bread products would limit consumer choice to buying organic bread or making it at home with unforti?ed ?ours. Option Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat ?our for bread-making would be forti?ed with folic acid at the flour-milling stage. in general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folio acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Yes El Disagree. El Unsure. Please explain why and provide any evidence you may have: Agree with the uptake of this option. The process of monitoring would be simpli?ed compared to option 3a as there a smaller number of mills to check compliance versus individual bakeries. Health Impact - As the supporting docunent states this option would have a signi?cant health impact by reducing NTD rates by 10?20%. Cost Effectiveness - As this option would have signi?cant set up costs for millers, why should millers have to absorb these costs? Forlifying wheat with folic acid is a government initiative that has potentiai to improve lives of New Zealanders and save the country millions in heatth care for NTD affected individuals and their families. Could government help absorb set up costs as the potential benefits of reduced NTD affected pregnacies will bene?t government budgets. I feel govemment should also provide the folic acid to millers with a long term stepwise plan for mitiers to purchase this. Will this option have a direct impact on the price of bread for consumers? Equity - this option would help reduce disparity in NTD rates between NZ women, particuiarly young women, those with tess education and Maori women who have higher rates of NTD than Non Maori. Consumer choice - limited to organic and non-wheat breads eg made from com, rice. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option So would require the forti?cation of all non-organic wheat ?our, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 30 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY t3 Agree. CI Disagree. Yes El Unsure. Please explain why and provide any evidence you may have: Disagree with forti?ying all wheat flour to be used in any foods which contain wheat. This is because the upper level of safe foiic acid intake could be exceeded; Health impact As per the supporting technical inform ation which states that this option would risk overconsumption of foiic acid in children aged 5-3 years due to the wide range of foods that would be forti?ed including sauces, soups, biscuits, cakes. as well as bread etc- Cost Effectiveness as per the other options, there would be huge start up costs for industry. Equity would provide the best coverage for WCBA, however at the detriment of some children who's intake of foiic acid couid exceed safe upper limits. Consumer choice - This option also removes all consumer choice if consumers wish to purchase unfortilied wheat ?our products as it would be added to all products containing wheat. it would ieave choice to only organic products. Implementation provides information on the proposed approaches to implementation for the three options presented on pages 46 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO El Agree. 8 Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? Unsure The information provided in the discussion document appears to provide support to industry to comply with mandatory forti?cation. General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. Auckland Regional Public Health Service Beam! Ml om Mm new ?a?v - l1: 3?33?- Liam: 3 ct- November 2019 Consuitation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submission on New Zealand Food Safety Discussion paper ?Folic acid forti?cation: Increasing the folic acid availability in food? Thank you for the opportunity for Auckland Regional Public Health Service to provide a submission on the Ministry of Primary industries (MPI), New Zeaiand Food Safety Discussion paper "Folic acid forti?cation: Increasing the folic acid availability in food.? The foiiowing submission represents the views of ARPHS and does not necessarily reflect the views of the three District Health Boards it serves. Please refer to Appendix 1 for more information on ARPHS. The primary contact point for this submission is: Madelon de Jongh Auckland Regional Public Health Service Your sincerely McEntee Michael Hale General Manager Medical Officer of Health Auckland Regional Public Health Service Auckland Regional Public Health Service Auckland Regional Public Heaith Service Level 3, Buiiding 15, Cornwall Complex, Greeniane Clinical Centre, Auckland Private Bag 92 605. Symonds St, Auckland 1150, New Zealand Teiephone: +54 (09) 623 4600 IUBMSSION Overview and recommendations 1. Thank you for the opportunity for Auckland Regional Public Health Service (ARPHS) to provide a submission on the Ministry for Primary industries New Zealand Food Safety discussion paper entitled ?Folic acid forti?cation: Increasing the folic acid availability in food.? 2. ARPHS overall supports the proposal of mandatory folic acid fortification of food. Folic acid is essential for reducing the risk of neural tube defects (Ni?Ds). Neural tube defects are a serious heaith problem, with the burden of the disease not spread equitably across the population. 3. M?ori women are experiencing a higher rate of NTD live births than any other population group.1 increasing the availability of folic acid in food will therefore reduce the chance of NTDs affected pregnancies. As M?ori women experience a higher ievel of MOS, this policy has the potential to address existing health inequities. 4. Our main submission points are that: ARPHS endorses the ?ndings of the overall assessment from the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi which concluded that, ?be sed on an overali assessment of the evidence, and also considering the need to ensure that disadvantaged people including Maori receive bene?t, the benefits of mandatory forti?cation of packaged bread with folic acid outweigh any potential adverse effects."2 ARPHS therefore supports the fortification of bread and considers that both Option so (Mandatory forti?cation of all non?organic bread) and Option 3b (Mandatory forti?cation of non-organic wheat ?our for bread making purposese MPl's preferred option) will achieve the desired outcome from a population health perspective. 6 ARPHS supports the problem definition as described in the ham consultation paper and the four assessment criteria as defined by to assess the fortification vehicles being: Health impacts will the overall health outcomes improve? 0 Cost effectiveness - will the option be cost effective? it Equity - will equitable outcomes be achieved for alt women of childbearing age? 0 Consumer choice will some consumer choice be maintained?3 Recognising that the current consultation is limited to determining the best option for fortifying food, it is also important to highlight the need to carefully consider actions relating to the implementation of folic acid forti?cation. Implementation actions should include: Careful monitoring of the implementation and effect of the chosen forti?cation option, to ensure the policy continues to meet the objective of reducing NTBs, takes into consideration any new ?ndings in relationship to folic acid consumption and ensures equitable outcomes across the population; . implementing a monitoring regime to ensure compliance with the new standard by the industry; 1 Voluntary Follc Acid Forti?cation: Monitoring and Evaluation Report. MPI technical pa per no: 2018/02. 2 The Health Bene?ts and Risks of FolicAcid Puri?cation of Food: A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Apara (June 2018} 3 Folic acid forti?cation: Increasing folic acid availability on food. New Zealand Food Safety Discussion Paper No: 2019/08. Auckland Regionai Public Heaith Service page 2 {sures/155mm Ensuring clear labelling on packaged bread, advising women planning to become pregnant or aireacly pregnant to consult their health provider to discuss their specific need for folic acid supplementation; and . Ensuring that the Ministry of Health guidelines for pregnant women are being reviewed in light of the new fortification regime, to ensure the upper intake level for folic acid will not be exceeded if women consume forti?ed products at the same time as using the currently recommended supplements. This review should also take into account changes in dietary consumption patterns, and be monitored over time. Background neural tube defects . S. Folate is an important 3 vitamin naturally present in some foods including green leafy vegetabies, legumes and liver. Its form, known as folic acid, is used to fortify food and is a component of many dietary supplements. Folic acid is more bioavailable and more stable than folate from food .4 A lack of folic acid during the first trimester pregnancy can lead to the development of neural tube defects (NTDs). Neural tube defects are one of the most common birth defects that affect foetal brain and spinal cord development in the very early stages of pregnancy, before most women realise they are pregnant. Depending on the type of defect, babies with NTDs may be stillborn or die shortly after birth. Those infants that do survive have severe, life?long disabilities. Each NTD affected pregnancy comes at a high social cost for impacted families and whana u. The burden of MOS for society is signi?cant due to the on?going social, ?nancial and implications of the disease.5 Addressing health inequities While folic acid forti?cation is a strategy to improve the folate status of women of child bearing age (WCBA) in general, it may confer special bene?ts to women who are at social and economic disadvantage as seen in the US and Australia. Date from Australia show that indigenous women had higher reported NTD rates pro-mandatory forti?cation and experienced the greatest decline post?forti?cation. The same was true for the Hispanic woman in the US.6 Live birth-data have identified a difference in NTD rates between Miori and New Zealand European women. These data suggest that Maori women may, similarly, receive greater relative bene?t from mandatory fortification although the extent of the potentiai impact is not clear.? The re port of the Chief Science Advisor further notes that all public policies shouid be designed and implemented within a Treaty of Waitangi framework, and that irrespective of the policy decision on folic acid fortification, Maori should be centrally involved in the decision?making process. Moreover, the report states that ?every effort is made to ensure that they (Maori) 4 Ministry of Health. 2005. Food and Nutrition Guidelines for Healthy Pregnant and Breastfeeding Women: A background paper. Wellington: Ministry of Health. 5 The Health Benefits and Risks of Fain: Acid Fortification of Food; A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi (June 2018) Auckland Regional Public Health Service Page 3 receive equal bene?t from the in line with this, ARPHS recommends that MPI ensure active engagement of Maori in this consultation. Other considerations 9. To minimise the risk of unintended consequences of mandatory fortification ARPHS . recommends on-going monitoring of the health impacts to ensure the policy continues tomeet the objective of reducing NTDs, takes into consideration any new ?ndings in relationship to folic acid consumption and ensures equitable outcomes across the population. 10. It is recognised that it may take some time for the industry to change their production processes to meet the new forti?cation standards. An appropriate monitoring regime is recommended to ensure compliance with the new standard by the industry. Assistance may be appropriate to the food industry with adequate training on how to implement and comply with the new standards. 11. in light of the new forti?cation regime, ARPHS recommends that the Ministry of Heaith (Mel-l) guidelines for pregnant women are reviewed, to ensure that the upper intake level for folic acid will not be exceeded if women consume fortified products at the same time as the currently recommended supplements. This review should also take into account changes in dietary consumption patterns and be monitored overtime. 12. in addition, ARPHS recommends clear labelling on bread packaging, advising women planning to become pregnant, and women already pregnant, to consult their health provider to discuss their specific need for folic acid supplementation. A comprehensive national educationai campaign will be required for both the public as well as health care providers. Conclusion 13. Thank you for the opportunity to comment on the MN consultation on New Zealand Food Safety discussion paper ?Folic acid forti?cation: Increasing the folic acid availability in food.? 8 The Health Bene?ts and Risks of Folic Acid Forti?cation of Food: A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi {June 2918) Auckland Regional Public Health Service Page 4 Appendix 1: Auckland Regional Public Health Service Auckland Regionai Fublic Heaith Service (ARPHS) provides pubiic health services for the three district health boa (DHBs) in the Auckland region (Counties Manukau Health, Auckland and Waitemata District Health Boards). ARPHS has a statutory obligation under the New Zeaiand Pubiic Health and Disability Act 2000 to improve, promote and protect the health of people and communities in the Auckland region. The Medical Of?cer of Health has an enforcement and regulatory role under the Health Act 1956 and other legislative designations to protect the health of the community. primary role is to improve population health. it actively seeks to influence any initiatives or proposals that may affect population health in the Auckland region to maximise their positive impact and minimise possible negative effects. The Auckland regien faces a number of public health challenges through changing demographics, increasingly diverse communities, increasing incidence of lifestyle-related health conditions such as obesity and type 2 diabetes, infrastructure requirements, the balancing of transport needs, and the reconciliation of urban design and urban intensi?cation issues. I Auckland Regional Public Health Service page 5 Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient fol ic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand's rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be significant for many whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voiuntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended tevei, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposats. Once you have completed this form Email ta: While we prefer email, you can also post your submission to: Consultation: Foiic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. .. 3.14 Submitter details: Name of submitter Bradbury or contact person: University of Auckland. Organisation (if applicable): This is a submission on behalf of the following public health nutrition or public heaith researchers: Dr Bradbury Dr Helen Eyles Dr Sarah Gerritsen Dr Teresa Gontijo de Castro Professor Cliona Ni Mhurchu Dr Sally Mackay Anna?Marie Rattray Dr Leanne Young Email: k.bradbury@auckland.ac.nz Of?cial information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Official Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. El Unsure. Please expiain why: Between 2008 and 2013, 381 neural tube defects occurred in Aotearoa-New Zealand this is a rate of 10.2 per 10,000 births, and includes live births, still births and terminations (MPI Technical Paper No: 2018f02). The experience of other countries indicates it could be reduced to around 7-3 per 10,000 births with a mandatory foiic acid forti?cation programme (De Wals et at, Engi Med 2007;357:135442; Williams et al., MMWR Hertrampf Cortes Food and Nutrition Bulletin 20082962316237). Therefore, there is a signi?cant number of NTDs that could be prevented with greater foiic acid forti?cation. Of note, the live birth prevalence of NTDs are signi?cantly higher in Maori women {4.58 per 10,000), compared to NZ European and other women (2.81 per 10,000) Paci?c women also have a high live birth prevalence (4.09 per 10,000) although this was not statistically signi?cantly different from other ethnicities, possibly because of smaller numbers in this group (MPI Technical Paper NO: 2018I02). Greater coverage of folic acid fortification would reach more women and reduce inequalities in live birth NTD prevalence. To get a fuller picture of whether the true NTD rate differs by ethnicity it is necessary to report prevalence of the sum of live births, stilt births and terminations by ethnicity, and the NZ Births Defect registry should report NTD rates on an annual basis (perhaps pooling data over several years, due to small absolute numbers). The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OF THE Agree. Disagree. Unsure. Please expiain why: We agree with the objective to increase consumption of folic acid forti?ed food to reduce NTD- affected pregnancies. We also agree that an important objectives is to increase equity. We suppon the objective to minimise impacts for the industry (millers and/or bakers), as this would also reduce the additional cost passed on to the consumer. Finally we think an additions! objective should be to ensure it is feasible to regularly monitor the concentration of folic acid in the target vehicle. We think there shouldn?t be undue emphasis put on preserving consumer choice. The success of a mandatory forti?cation programme is due to the fact that it does not requires behaviour change from consumers, they continue to pwchase and eat food as normal but have a higher intake of, in this case, folio acid. in addition, in all three options consumer choice would be protected somewhat because organic bread and non-wheat breads would not be forti?ed. We think an additional objective should be safety, with no adverse long-term outcomes. As well as continuing to monitor forti?cation, we think should continue to assess the evidence for the relationship between folic acid and cancer risk. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. - Disagree. El Unsure. Please explain why and provide any evidence you may have: Under the status quo, NTDs are occurring that could be prevented by greater coverage of folic acid forti?cation. Pregnancies are not evenly distributed amongst population groups, with Maori and Paci?c women having on average more children than non-MaorilPaci?c women (Statistics N2 2018)- Additionally, at least 40% of pregnancies in Aotearoa-NZ are unptanned, and the Growing Up in New Zeaiand study found mothers with unplanned pregnancies were less likely to take folic acid before pregnancy than mothers with a planned pregnancy compared with 58%, respectively. Morton et al. 2010 Before we are born). Altogether, hearty 16% of all mothers in the Growing Up in New Zealand study did not take folic acid at any time before or during their pregnancy. Simulation studies in Aotearoa-NZ, including one based on data from Growing Up in New Zealand, indicate that mandatory folic acid forti?cation of a food staple would reduce disparities in intake of folic acid. (T eixeira et al. Public Health Nutr Evans et al. Public Health Nutr Maitard et al. Huma Reprod However, the latest representative detaiied information available on the dietary patterns of New Zeaianders is from ZOUBIZOOQ and there is an urgent need for a national nutrition survey to ensure both the target dose and the vehicle of any mandatory forti?cation programme is optimal to increase folic acid intakes across all women of childbearing age. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the voiume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. Disagree. i3 Unsure. Please explain why and provide any evidence you may have: In 2012 the government asked bread manufacturers to aim to fortify 50% of sliced packaged breads (by sales volume} with folic acid. It took 2 years to develop the NZAB {New Zealand Association of Bakers) and Private Label Partners? Code of Practice, which was introduced in 2014. Not all members are signatories of the Code of Practice. Progress towards the 50% of target has been slow - in 2012 14% of packaged sliced bread was forti?ed and over 4 years this increased to 38% in 2016. This equates to a 6 percentage point increase per year; if current trends continue it would take until 2023 to reach an 80% target. During this time many NTDs would occur that could have been prevented. There is no guarantee that the bread manufacturers will actually work towards an 80% target. and no accountability or repercussions if they do not meet the target. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of foiic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY El Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: Yes, this option wouid likely reduce NTDs and reduce inequalities in NTD rates across different ethnicities in Aotearoa-NZ. However, because forti?cation would happen at the level of the bakery, this would result in all bakeries having to set up their own fortification processes. This is obviously not a streamlined approach and it would be dif?cult to ensure that each bakery?s procedures resulted in folic acid being within the target range in the ?nai product. it would be dif?cult for to regularly monitor folic acid concentrations in breads from ail New Zeaiand bakeries. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be forti?ed with folic acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option so against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: This option would reduce NTDs and reduce inequalities in NTD rates, while increasing reach to women who do not eat a lot of bread (as folic acid would end up in products that are not typical breads}. ltwoutd also reduce the opportunity for error because hundreds of bakeries would not have to individually fortify their bread. There would be extra cost to the millers, and they would need to set up systems to fortify the flour. Australia implemented this option in 2009 and this has resuited in overall a 14% reduction in NTD incidence, with particularly large reductions among Aboriginal and Torres Strait islanders (74% reduction) and teenage mothers (55% reduction). The success in Australia demonstrates that this option is feasible. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option 30 would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: Yes, this option would result in the greatest delivery of folic acid in the food supply. However under this option, modelling data suggests that some children would have high intakes, although the upper limit f(Ut.) for children is extrapolated from the UL for older adults, and therefore it is unclear if consumption above the UL poses a risk for children. Nevertheless, if this option was chosen, it is essential that there would be regular monitoring of the folate status of chitdren (Le. at least every 5 years), and that MPI keep up-to-date on any adverse effects. Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? General comments lf you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availabilin/ in food discussion paper, please let us know. 10 We support mandatory forti?cation as the most effective option to reduce NTDs and reduce inequalities in NTD rates between mothers of different ethnicities and ages. NTDs are more common in parts of the world which have voluntary rather than mandatory folic acid forti?cation programmes (Atta et al., Am Public Health A mandatory option that enables the most accurate dosing of folic acid into the target vehicle throughout the country should be adopted. Whatever option is adopted, its implantation and impact should be fully monitored. This should include monitoring population NTD rates, including an annual report of NTDs in New Zealand. MPI should also monitor the concentration of folio acid in forti?ed products. Because there is concern from genetic studies about the possibility of an increase in specific types of cancers with higher biood folate levels, associated trends in cancer incidence should also be monitored. Although we note that trends in cancer incidence would have to be interpreted carefully as they would be impacted by other factors such as uptake of cancer screening, and there will likely be contemporary changes in bowel cancer and possibly prostate cancer screening participation in New Zealand. The evidence on the association between foiic acid and cancer risk should be regularly reviewed. It will also be important to monitor population blood folate status, in nationally representative samples, via the NZ Health Survey or future National Nutrition Surveys. As well as monitoring blood folate status of the general population and women of childbearing age. blood folate status of pregnant women and their infants should also be monitored. Currently, women trying to become pregnant or who have a pregnancy con?rmed and who have accessed a health professional (GP or midwife) are prescribed an 800 tablet of folic acid. Data from Growing Up in NZ showed that altogether 57% of the pregnant women extended the use of folic acid supplements past the ?rst trimester of pregnancy, where: 23.4% used the recommended folic acid supplement dose in the ?rst trimester but extended the use of foiic acid supplements beyond the first trimester and 33.2% took insuf?cient folic acid suppiements in the ?rst trimester of pregnancy but extended the use of supplements past the ?rst trimester of pregnancy (Teixeira et al. Public Health Nutr 2018; 21 :21 83). Some women also take multivitamins throughout pregnancy as well. Although mandatory folic acid forti?cation may increase folic acid intakes in this group, their main source of foiic acid is from high-dose foiic acid supplements. and an education programme for midwives and pharmacists should be considered so that they can inform pregnant women there is no need to take folic acid supplements past the ?rst trimester. Finally, the modelling of folic acid intakes through food is based on data from ZOOBIDQ and dietary patterns will almost certainly have changed over the past decade. Another national nutrition survey should be conducted as soon as possible to better understand current dietary patterns and evaluate the suitability of the forti?cant vehicle (bread) and the appropriate dose of folic acid. 11 Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming sufficient folio acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand's rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email to: Food.Policy@mgi.govt.nz White we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6194 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Kevrn Gilbert or contact person: Organisation (if applicable): BIANZ (Baking Industry Association of New Zealand) Email: kevin@bianz.co.nz Official Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Official Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zeaiand could be reduced if the blood folate leveis of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS El Agree. Disagree. l3 Unsure. Please explain why: Evidentially, the incidence of NTDs in New Zealand has dramatically reduced due to better diets, better scanning, awareness of the importance of folic acid during pregnancy, and the voluntary forti?cation of many foods already widely available. Rather than medicating the population (including the males for whom the impact is not part of the discussion), continued education has proven itself to be a key. Dosing the entire population, according the FSANZ, will potentially impact 3 out of 58,020 births. Less bread is being consumed especially amongst the target audience which means that this is the least ef?cient delivery option. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of chiidbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTWE OF THE El Agree. [El Disagree. Unsure. Please explain why: With a greater variety of foods available, diets adhered to and carbohydrates avoided, food is arguably the least ef?cient method of distribution. Bread the most ineffective of the options. Option 1: Maintaining the status quo Option 1 wouid involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE [3 Agree. Disagree. [3 Unsure. Please explain why and provide any evidence you may have: The data given was misleading in pieces and wrong in others. The claim this option is not equitable and the statement that Maori women would be be negatively impacted shows a glaring tack of understanding on the markets of the different bread types. The assumption that ?this option would aiso continue to present a oorrespondingiy high degree of uncertainty as to which products are for??ed? seems to completely avoid the discussion of a, far simpler, option of mandating labelling requirements to clearly identify which are and which are not. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would invoive asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY [3 Agree. l3 Disagree. Ci Unsure. Please explain why and provide any evidence you may have: This seems the simplest, fastest, most ?nancially viable and effective of the appioaches. It retains the consumers choice to the highest level possible, it reaches the widest margin, education is easier, no businesses are likely to be forced to close due to decreased turnover. Option 3a: Mandatory forti?cation of non-organic bread Option So would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would con?nue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID OF BREAD AGAINST THE CRITERIA AND LIKELY Cl Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: This is a thoroughly impractical option as understood. The margin for error is signi?cantplus it completely removes the consumers choice from a practical standpoint. If, however, the forti?cation is made by way of an addition to dough premixesladditives, already used by most supermarkets plant bakeries and many smaller bakeries, this would alleviate concerns for mis-dosing, provide the widest distribution possible and all while still allowing the consumer a choice. Option Mandatory forti?cation of non-organic bread-making wheat flour Under option 3b, all non-organic wheat flour for bread-making would be fortified with folio acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY [3 Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: This removes all consumer choice, negatively impacts manufacturers using New Zealand products as they will no longer be able to leverage their point of difference, locally and on the international market, of making a product from solely New Zealand ingredients. This has negatively impacted the baking industry in Australia. This also demonises bread while potentially making biscuits and cakes appear healthier and less adulterated. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option So would require the forti?cation of all non-organic wheat ?our, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts. cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE AND LIKELY El Agree. Disagree. Cl Unsure. Piease explain why and provide any evidence you may have: This option is the most damaging and potentially harmful both to the population, the consumer, and to businesses in New Zealand. While it cannot be argued that dosing every product made with flour (that isn?t organic} will achieve the widest distribution, the rami?cations of potential over consumption especially of 58-year olds is too great. The almost complete removal of the consumers choice is never a good option and the negative impact on, especialiy exporting companies, is substantially greater than option 3b. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? As we disagree with all the options laid out as they are except option 2, we also disagree with the implementation approaches to those options The proposed implementation to option 2 seems fair and reasonable Genera! comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. We would be interested to know if the costs shown to be associated with each option are solely based around governmental outlay or, as should be the case, also include the costs to businesses. Do they also include the increased unemployment expenses that will likely occur due to a decrease in business revenue (most likely in the export market}? It is noting that while closing all men, children and the elderly, even some of the target - women of childbearing years - will not gain any bene?t because their folate levels are aiready within the low risk range. We continue to be adamant that the medication of the entire population is a ludicrous step to take for the fraction of births effected For those families being saved from a lifetime of disability this is no doubt priceless. However, the issue is the potential risk (and costs) to all other New Zealanders, some 4.4 million citizens who face the unknown potential effects. The impact on other New Zealanders from this mass-medication programme seems to have been either generally dismissed as insigni?cant or ignored while some academics accept that such an intervention represents ?an uncontrolled ciinical trial with all New Zealanders as participants". We request that we are involved in all future discussions about this and kept advised as a key industry stakeholder. Cancer Society Te Kabul Matepukupuku Aotearoa Submission: Folate Fortification introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folio acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be significant for many families, whanau, and communities across New Zeatand. recognises the importance of this issue and is seeking feedback on whether the government should: 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 30% of packaged sliced bread, or - introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any hannfui health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email t0: While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministiy for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Vicki Robinson, Health Promotion Advisor, Advocacy and Wellbeing . Name 0 Cancer Society of NZ. or contact person: Organisation (if applicable): Cancer Sootety NZ Email: Vicki@cancer.org.nz Of?cial Information Act 1982 All submissions are subject to the Of?cial information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MFI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food. sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zeaiand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. Cl Unsure. Please explain why: The Cancer Society NZ is a non-pro?t organisation which aims to minimise the incidence and impact of cancer an alt those living in New Zealand. We work across the cancer continuum with key work areas that include health promotion, supportive care, provision of information and resources, and funding of research. The Cancer Society NZ is making a submission on folate forti?cation of food due to the potential for both protective and adverse effects of folate on cancer risk. The Cancer Society NZ supports the evidence for the protective effects of folic acid to reduce neural tube defect (NTD) risk in babies that has been clearly identified by literature provided by Despite folate supplementation pen-conception, voluntary folate forti?cation since 2009 and rising number of foods identi?ed with folate, many women especially Maori woman do not get suf?cient folate and rates of neural tube defects remain too high. Voluntary fortification necessitates the good will of the food industry. The modelling undertaking by MPI has shown insuf?cient uptake of the Bakers Voluntary Code of Practise to fortify breads by industry with less than the recommended 50% of food currently forti?ed. While improvements in NTDs have improved since 2009, woman of child bearing age continue to have low folate tevels and high NTD rates and inequity continuesz. The industry lead code for voluntary forti?cation of breads has been insuf?cient to improve NTDs markedly and even less so for our most vulnerable populations. Due to the continued high levels of NTDs and barriers for women of childbearing age to obtain adequate folate, the Cancer Society NZ agrees that voluntary forti?cation is insuf?cient and stronger measures are needed to promote folate intake to reduce rates of NTDs. However due to the research inconsistencies about folate supplementation and adverse cancer risk the Cancer Society also recommends its continued research and monitoring (see below). Ministry of Primary industries, Voluntary Folic Acid Forti?cation: Monitoring and Evaluation Report, Feb 2018. 3 Of?ce of Prime Ministers Chief Science Advisor and the Royal Society Te Aparangj. The Health Bene?ts and Risk of Folic Acid Forti?cation of Food. June 2018 available from The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. Unsure. Please explain why: Despite folate being available naturally in our food supply and in forti?ed foods, many women (with greater numbers of Maori) do not achieve adequate folate rich diets including fruit, vegetables, breads and cereals? Folate supplementation pen-conception is also poorly utilised partly as over fifty percent of women do not plan pregnancy or know of their pregnancy until neural tube development is almost complete. Mandatory folate forti?cation has lowered rates of NTDs and improved equity for vulnerable populations in other countries. Since 2009 Australia changed from voluntary to mandatory forti?cation of folate into wheat ?our for bread making and successfully reduced rates of NTDs and disparities signi?cantly for disadvantaged Aboriginal women?. The cost bene?ts of doing so have also been found to be highly effective". Mandatory fortification will positively impact the folic acid intake of more New Zealanders than current levels of voluntary forti?cations. Folic acid forti?cation of commonly consumed foods can be a reliable and effective way to attain health bene?ts by increasing the nutrient intake of a population without relying on individual supplementation practices9. The Cancer Society supports strengthening folate fortification in our food supply as an effective way to reduce NTDs but recommends continued research and monitoring of cancer risks. 3 Ministry of Health, NZ Health Survey. Regional Data Explorer, 2019, available from h- 'Ilmin in lo] - 4 Slagman A, Harris L., Campbell S, et al- Folic acid de?ciency declined substantidly after introduction of ?re mandatory fortiioe?on progranme in Queensland, Public Health Nutrition. August 2018- 10.1017l31368980019002258. Australia: a secondary health data analysis 5 Slagrnan A, Harris L., Campbell S, at a. Low proportions of folic acid de?ciency after introduction of mandatory folic acid fort'frcation in remote area of northern Queensland, Australia: a secondary health data analysis, Biomarkers, 2019. 24:7, 684- 691. DOI: 10.108011354750x.2019.1652346 6 D'Antoine, H., Bower, C. Folate Status and Neural Tube Defects in Aborig?nal Australians: the Success of Mandatory Forti?cation in Reducing a Hedth Disparity. Current Developments in Nutrition. 2019.3, available from 7 Saing, 3-, Haywood, P-, van der Linden, at a, Real?World Cost Effediveness of Mandatory Folic Acid Forti?cation of Bread Making Flour in Australia, 2019, 9, 17:243-254 at 9 Food Standards Australia New Zealand. Proposal P295 Consideration of Mandatory Forti?cation with Folic Acid: First Review Report 2007. 9 Food Standards Australia New Zealand- Proposal P295: Consideration of mandatory fortifrca?on with folic acid; Final Assessment Report- 2006. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE 3 Agree. I3 Disagree. Unsure. Please explain why and provide any evidence you may have: We agree with MPIs assessment but support mandatory folic acid forti?cation due to the limited impact of the status quo on foiic acid intake in women under 56 years. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. CI Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with assessment but support mandatory folic acid forti?cation due to the limited impact of voluntary forti?cation on folic acid intake in women under 50 years. industry to date have not reached its voluntary forti?cation rates of 50%. The Cancer Society is supportive of strengthening folate fortification and making it mandatory to improve folate forti?cation levels. More widespread folate fortification is likely to improve uptake and reduce NTDs in vulnerable groups. Option 3a: Mandatory forti?cation of non-organic bread Option So would see bread fortified with folic acid at the bread-making stage. it would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. l3 Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory folic acid forti?cation Option 3b based on the modelling and data provided by MPI. Despite Option 33 having the capacity to make good improvements in equitable outcomes for NDTs, the implementation dif?culties, high costs to implement and monitoring and limitations in food choice for consumers make this option undesirabie. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be fortified with folic acid at the flour-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY IMPAC Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: The Cancer Society agrees with the assessment and supports Option 3b: Mandatory Forti?cation of Non Organic bread making wheat flour based on the evidence provided by MPI. Option appears to provide the best balance between increasing folate of the population and - health risk improvement (of NDTs and impacts on other populations) - the wider reach to vulnerable populations to improve inequities of NDTs - cost and to a less extent - consumer choice This would also align well with Australia Food Standards and their forti?cation emeriences. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the forti?cation of ali non-organic wheat ?our, whether m?led in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3c against the criteria for heaith impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory folic acid fortification Option 3b based on the tower number of young chiidren exposed to levels of folic acid above the upper limit Despite the better health improvements and equity of health outcomes this option wouid bring, the high cost of implementation and limitations for consumers to opt out make this choice tess desirable than option b- Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. [1 Disagree. CI Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? This is beyond the scope of our expertise but the proposed approaches to implementation for the three options presented on pages 40-43 in the discussion paper sounds reasonable. The food industry is better equipped to comment on this. General comments it you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. Folate is important for the normal function of healthy cells and forti?cation is an effective and equitable way to address low folate intake/?levels in woman of childbearing age to reduce NTDs. Evidence ?nds both a protective effect of high folate inta ker'ievets for some cancers but also inconsistent adverse associations across different study types especially for those with pro-existing tumours. However overall re port recommendations consistently advise that the bene?ts of folic acid forti?cation outweigh any potential risk for cancer10111213 These recommendations aiign with the Cancer Society?s 2011 Position Statement on Folate and Cancer Risk Due to some uncertainty about high folate and cancer links the Cancer Society continues to recommend people with existing bowel adenomas and those with an increased risk of developing bowel adenomas avoid taking high-dose folic acid supplements (above the upper limit of hog (1000319) per day. This aligns with the Worid Cancer Research Fund recommendations to avoid high dose folic acid and dietary supplements for cancer prevention?. The Cancer Society supports Option 3b: Mandatory forti?cation of non-organic bread-making wheat flour. The Cancer Society agree that the benefits of folic acid supplementation outweigh those of any potential cancer effects and will particularly bene?t those most at risk. Due to the research inconsistencies about folate supplementation and cancer risk the Cancer Society also recommends its continued research and monitoring. Food Security impacts at least 19% of households in New Zealand with greater rates experienced in tow income and more deprived neighbourhoods, Maori and Paci?c populations and families with greater numbers of children?s". Food insecure households are less likely meet the recommendations for fruit and vegetable intake com pare to food secure households. The Cancer Society recommends that strategies to support food insecure women to easily access healthy affordable food are also addressed alongside folic acid forti?cation as an important way to address inequities in food choice, NTDs and health. 1" Scientific Advisory Committee on Nutrition. Update on Folic Acid- 201?. 1? Centeno Tabiante, E-, Guettennan,HM., Finketstein,JL., Forti?cation of wheat and maize flour with folic acid for population hedth outcomes. Cochrane Database of Systematic Reviews 2019, Issue ?2 World Cancer Research FundlAmerican Institute for Cancer Research. Diet, Nutrition, Physical Activity and Cancer: a Global Perspective. Continuous Update Project Expert Report 2018. p8, of chapter Diet nutrition physicai activity and colorectd cancer. ?3 Of?ce of Prime Ministers Chief Science Advisor and the Royal Society Te Aparangi. The Health Bene?ts and Risk of Folic Acid Forti?cation of Food. June 2018, available at of~fgig?gdforti?ca?oncpfoodgg 1* The Cancer Society of NZ, Position Statement on Folate and Reducing Cancer Risk, March 2011 Cmcer ?fety NZ, available at hugs-ficancemzorg ?5 World Cancer Research FundlAmerican Institute for Cancer Research. Diet, Nutrr'licvr, Physical Activity and Cancer: 8 Global Perspective. Continuous Update Project Expert Report 2018. p8, of chapter Diet nutrition physicat activity and colorectal cancer 1? Aucktand City Mission, Shining the Light on Few Security in Aoteoroa, 2019. Auckland City Mission. ?7 Ministry of Health Household Food Insecurity Among Children: New Zealand Health Survey". Summary of ?ndings. 2019. Wellington: Ministry of Heaith. 10 Submission Form Introduction Foiic acid is an essential vitamin important for the heaithy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folio acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zeaiand. recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged siiced bread, or - introduce mandatory forti?cation of bread, bread-making wheat flour, or ait wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. Ail options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the pubiic will help us understand the possible impacts of the proposais. Once you have completed this form Email to: FoodPolicmegigg?mz While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Peel Submissmn Coordinator or contact person: Organisation (if applicable): Canterbury District Health Board Email: kirsty.peel@cdhb.heaith.nz Person approving submission Evon Currie. Generat Manager, Community and Public Health on behalf of Executive Management Team Date 8 November 2019 Signature 2 Official Information Act 1982 All submissions are subject to the Of?cial information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zeaiand could be reduced if the biood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough fclate from natural food sources to ensure Optimal btood foiate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the impedance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntariiy forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. [3 Disagree. I3 Unsure. Please explain why: The Canterbury District Heatth Board (DHB) acknowiedges the significant impact of folic acid- sensitive MTG-affected pregnancies. As the South Island regional referral centre for fetal abnormalities, our fete-maternal medicine service sees women and their partners with pregnancies affected by neural tube defects. We have experience in counselling. arranging the termination of pregnancy (where desired) and managing these pregnancies and know the devastating impact that this diagnosis has on a women, her partner and whanau and this applies irrespective of the choice or not to terminate the pregnancy. Local data con?rms the problem of unplanned pregnancies and iate booking with a LMC resulting in reduced opportunities for supplementation. The Canterbury DHB acknowledges the potential inequities in health outcomes (with only 56.6% of Paci?c women registering with an LMC in the first trimester in 2017 compared to 67.6% for Maori and 85% for European?) and recommends that these inequities are acknowledged in this overview of the problem de?nition. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equiv] of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. El Unsure. 1Ministry of Health. 2019. New Zeaiand Maternity Clinical indicators 2017. Wellington: Ministry of Health - accessed on 30/10/-clinl - -tren Piease expiain why: The Canterbury DHB supports the abjective to increase the consumption of folic acid through fortifying food commonly consumed by women of chiid bearing age to reduce the number of NTD- affected pregnancies, given that the current voluntary regime has not achieved its desired goal. It aiso supports a focus on health equity and considering health impacts as well as consumer choice. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE El Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: The Canterbury DHB agrees that this option vn?ll not affect the improvements required to solve the problem as de?ned. Current voluntary measures are not even meeting the 50% forti?cation target and hence having limited impact and not reducing health inequities. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY El Agree. El Disagree. 8 Unsure. Please explain why and provide any evidence you may have: The Canterbury DHB cannot comment on impacts on industry or likely further take-up of voluntary codes by industry. if an 86% target was able to be reached it would provide better coverage than currently achieved and retain some consumer choice, however the Canterbury DHB preference is for mandatory approaches that have a better chance of reducing health inequities. Option 33: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat com and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. [3 Disagree. El Unsure. Please explain why and provide any evidence you may have: The industry impact and cost would likely be too great and likely to discriminate disproportionately against small businesses. Option 31): Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be forti?ed with folic acid at the ?our-milling stage. In general, foiic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into ?our for bread-making purposes would not be tequired to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals}. has assessed option 3b against the criteria for health impacts, cost effectiveness. equity. consumer choice, and other impacts on pages 30 - 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-M AKING WHEAT FLOIJR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please expiain why and provide any evidence you may have: This is the Canterbury preferred option according to the available evidence. it stiil allows some (albeit limited) consumer choice for other products (cakes I alternative flours and organic products) but has less cost and dif?culty to implement and has less risk of inadvertent overdose of folic acid to children than option Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code wouid continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed op?on 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: The Canterbury DHB considers this option is more restrictive with less consumer choice for those people wishing to avoid folic acid. The increased risk of overconsumption by infants is also a concem. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. l3 Disagree. l3 Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? No comment General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availabilihl in food discussion paper, please let us know. The Canterbury DHB supports mandatory forti?cation, and suggests option 30:) is the most pragmatic option to proceed with. The Canterbury DHB suggests that on-going monitoring of emerging research of the health impacts of increased foiate for those with the MTH FR SNP variant be undertaken to ensure there are no unintended consequences for this population of mandatory forti?cation. The Canterbury DHB promotes a multifactorial approach to changing systems to effect positive outcomes. We recommend that fortification should be considered alongside public health campaigns, dietary education as welt as clear front of packaging and in store This wili support public understanding of the changes and their rationale and facilitate consumer choice. This will be particularly important for that group of the popuiation aware of their MTH FR status who wish to avoid folic acid supplementation. The Canterbury BHB suggests that MPI consults with Maori regarding any cultural impiications of the options outlined. Capital Coast District Health Board x. OFOKO Kl 7E URU HAUORA 11 November 2019 Bryan Wilson Deputy Director~General New Zealand Food Safety Folic acid forti?cation submission support for option 3b Dear Bryan, Thank you for the opportunity to comment on the review of folic acid fortification of food. We would like to support proposed option 3b: introduce mandatory fortification of non?organic wheat flour used for making bread specialist bread-making flour would be fortified by the flour millers at the mill. Between the 17th and 30th day after conception (or 4 to 6 weeks after the first day of a woman's last menstrual period), is when the neural tube develops and so is the critical time to be taking adequate folic acid. it is very common that the woman may not even realise she is pregnant at this time and a high chance she has not seen a health care provider to start folic acid in this timeframe. Around half of all pregnancies in New Zealand are unplanned, and of those pregnancies that are planned, many do not see a health professional within the ?rst month of pregnancy, meaning they miss this key time for management discussions around pregnancy planning. In April 2017, the Ministry of Health commissioned Sir Peter Gluckman, at that time the Prime Minister? 5 Chief Science Advisor (PMCSA), and the Royal Society Te Aparangi to review the health benefits and risks of folic acid forti?cation of food. This involved a literature review and analysis of the available scientific evidence from New Zealand a nd internationally on the health benefits and risks of folic acid fortification. The report concludes that there is compelling evidence that mandatory folic acid fortification is associated with lower rates of neural tube defects, and that taking folic acid supplements at the recommended doses in pregnancy has no adverse effects on pregnancy outcome or the child?s health. No evidence was found to link the use of folic acid supplements or fortification to increased risks of neurological/cognitive decline, diabetes, or cardiovascular disease; nor was there evidence that nnmetabolised folic acid is harmful. forti?cation-of-food?gj NTDs are severe birth defects that can lead to miscarriage, stillbirth, or to lifelong and usually serious disabilities, with consequent costs to the affected individual, theirfamily/whanau, and society. The most recent complete NTD data for New Zealand show that in 2013, .18 babies were born with NTDs, with a further 6 babies being stillborn with an NTD. Because NTDs can be detected by ultrasound scan during pregnancy, many affected pregnancies are electiveiy terminated. Terminations result is signi?cant stress for the women and families/whanau involved. Any of these estimates on rates of NTD will be Capital 8: Coast DHB Private Bag 7902, Newtown, Wellington 6242 Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021 Phone: 04 385 5999 Fax: 04 385 5856 underestimated due to spontaneous pregnancy losses from spontaneous miscarriages, of which a proportion could be due to neural tube defects. Introducing mandatory fortification of non-organic wheat flour used for making bread would enable equitable folic acid availability to protect pregnancies at the criticai time in the development. Yours in ly g; a Rose Elder Carolyn Cotes Jay low Clinical Leader Obstetrics Director of Midwifery Clinica Leader Women?s Health Service Women's Health Service Women's Health Service Capital 8: Coast DHB Capital Coast DHB Capital 81 Coast DHB apital Coast DHB Private Bag 7902, Newtown, Wellington 6242 Wellington Regional Hospital, Riddiford Street, Newtown, Wellington 6021 Phone: 04 385 5999 I Fax: 04 385 5856 Submission Form Introduction Foiic acid is an essential vitamin important for the healthy deveiopment of babies eariy in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options wouid exclude organic products. We are seeking your feedback on these Options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email to: We While we prefer email, you can also post your submission to: Consuttation: Folic Acid Forti?cation Ministry for Primary lndust?es PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Caroie Glbb, New Zealand Registered Dietittan or contact person: Organisation (if applicable): Email: 5 Of?cial Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. [3 Disagree. Unsure. Please explain why: The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age. thereby reducing the number of NIB-affected pregnancies, while considering consumer choice. increasing equity of health outcomes. and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. Disagree. El Unsure. Please explain why: Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for heaith impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. [3 Disagree. [3 Unsure. Please explain why and provide any evidence you may have: 1. Voluntary forti?cation has not produced suf?cient reduction in NTD's to be deemed effective. I support mandatory forti?cation with folic acid as the only effective public health strategy for increasing the folic acid intake of women of child-bearing age who intend or may become pregnant, to a suf?cient ievel to effectively prevent neural tube defects (NTD), on a population levei. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 ievel of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY ll Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. Disagree. Unsure. Please explain why and provide any evidence you may have: Do not support this option as a complete compliance nightmare from the bread-makers through to the enforcers. of folic acid levels in bread likely to be very poor due to technical issues and expertise required. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be fortified with folic acid at the flour-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread?making purposes would not be required to be fortified with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. AGREE AND THIS IS THE OPTION I SUPPORT AS THE MOST EFFECTIVE, SAFE AND COST EFFECTIVE - see comments below. El Disagree. Unsure. Please explain why and provide any evidence you may have: 1. Mandatory forti?cation flour used in bread?making with folic acid can be easily achieved relatively inexpensively and with a high level of precision, whereas the mandatory forti?cation of bread with folic acid at the point of baking is fraught with df?culties, uncertainties and likely inaccuracies. 2. The number of flour mills in New Zealand producing bread-making flour using New Zealand ?our is small, being only six mills, and some of these are not likely to be producing wheat flour of suf?cient grade for bread-making flour. 0n the other hand, the number of bakeries making and selling bread would run into the hundreds. 3. I disagree that relatively little flour is imported to New Zealand, as stated on page 33 of the New Zealand Food Safety Discussion Paper No: 2019/08: in New Zealand, wheat?our is milled domestically to meet local market demands and relatively little flour is imported. A small {albeit potentially significant for some millers) quantity of bread-making wheat ?our is exported leg. in the form of frozen doughs) by some millers. Three-quarters of the bread sold in New Zealand is made from grain grown overseas, primarily Anstraiia (see link below) i.stuff.co.nzlbusiness/fa rming/ 1125032 38] more-kiwigrown-wheat?in-bread While note the move to increase the amount of New Zealand flour used in bread?making, the use of New Zealand flour is unlikely to overtake imported flour. This is because of limited supply - wheat is grown in the South Island in Canterbury, the cost of transport to the North island where the major flour mills and bakeries are situated may mean this is not economicaily feasible. In addition, depending on the weather, the wheat may not always be of suf?cient quantity or grade for bread-making, in which case imported flour would be needed as a replacement. 4. Australian bread-making flour must be fortified with folic acid under FSANZ regulations (mandatory forti?cation). New Zealand can therefore import bread-making flour from Australia which is already fortified with folic acid. This would reduce the cost of mandatory forti?caiton for New Zealand bakeries producing bread that do not use New Zealand flour. 5. Premixes of bread~making flour are widely used in the bakery industry. Australian bread pre-mixes (containing folic acid under FSANZ requirements) are being used by a number of Australian companries producing bread products in New Zealand e.g. Subway, Bakeres Delight, and North island Countdown stores. 6. recommend re-calculating the cost-bene?t ratios of Propoal 3b, taking into account the above. The cost of mandatory forti?cation of bread-making flour is likely to be much less than you have calculated, if 75% of bread-making flour used in New Zealand is Australian, and therefore can be easily supplied forti?ed with folic acid. therefore dispute the industry cost assertions on the cost implications of mandatory fortification of bread-making flour. A small (albeit potentially significant for some millers) quantity of bread-making wheat ?our is exported leg. in the form of frozen doughs) by some Millers. A segregation infrastructure may need to be developed if export markets demand unfortified bread-making flour and bread-making ?our products. There are likely to be some initial challenges, and some costs associated with set-up could be signi?cant. Large plant bakers would likely be able to absorb the costs better than small businesses. initial costs could include: [ii new silos, at an approximate cost of $300,000 each to ensure no cross contamination between forti?ed and unforti?ed flour; one or more micro-dosing machines for adding folic acid to floor, at a cost of approximately Seam each (a large milling operation may require up to six such machines); separate tankers to transport unfortified ?our without the risk ofcross-contaminotion; recon?guring milling processes and upskiiling staff; compliance costs. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c woutd require the forti?cation of all non-organic wheat ?our, whether in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY El Agree. [1 Disagree. El Unsure. Please explain why and provide any evidence you may have; Potential for higher levels but could be viable alternative to SB Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? General comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. This submission form is dif?cult to follow as it doesn't actually ask ?what is your preferred option?? 10 Coe?ac New Zealand PO Box 9734 Newmarket Auckiand 1149 +64 9 414 7467 admin@coeliac.org.nz 12?? November 2019 coeliac.org.nz To whom it may concern Re Coeliac NZ (CNZ) Submission on MPI Consultation of Folate Fortification of bread Submitted by CNZ on behalf of the CNZ Medical Advisory Panel hr: 5: coeliec.or .nz our-medicaI-advisors We acknowledge: That folic acid is an essential nutrient in the healthy development of babies in early pregnancy There is overwheiming evidence that consuming adequate folate prior to conception and in early pregnancy can prevent neural tube defects 0 That New Zealand?s rate of neural tube defects is higher than it should be with consequent significant financial, social and emotional impact 0 Educated, informed women who are financially able to, commonly seek supplementary foiate prior to and throughout pregnancy 0 That vulnerable sectors of the population are captured through the iolate fortification of staple foods such as bread i That other than the element of choice, no harm is done to the population as a whole when fortification is mandatory 0 There is signi?cant benefit to society as a whole through the better health and lifetime outcomes of reduced neural tube defects disease: is an auto-immune disease managed exclusively through the complete and lifelong exclusion of gluten from the diet disease affects 1:85 people A further group have giuten sensitivity (NCGS) and aiso need to exciude all gluten from their diets A further group choose to exclude gluten from their diets for perceived health bene?ts Gluten is a protein in wheat, rye, oats, barley and triciticale 0 Exclusion is defined as, no measurabie giuten (under 3 parts per million) 0 Those with disease and Non?coeliac gluten sensitivity are unable to consume regular folate fortified bread and therefore are excluded from the benefits of foiate fortification 0 Coeliac disease leads to inequitable health outcomes 0 We support Mandatory folate forti?cation of breads and cereals We propose 0 Mandatory folate fortification be extended to include giuten free breads, bake mixes and cereals Yours sincerely, Wendy Bremner General Manager Coeliac New Zealand incorporated T: 09 41474618 9(2Xl) e: w: Coeliac New Zealand incorporated I Charities Commission No CC27180 consumer. now you know 12 November 2019 Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 WELLINGTON 6104 By email: food.oolicv@moi.qovt.nz SUBMISSION on Folic Acid Fortification 1. Introduction Thank you for the opportunity to make a submission on folic acid forti?cation. This submission is from Consumer NZ, New Zealand?s leading consumer organisation. It has an acknowledged and respected reputation for independence and fairness as a provider of impartial and comprehensive consumer information and advice. Contact: Belinda Castles Consumer NZ PO Box 932 Wellington Central Wellington 6140 Phone: 04 384 7963 Email: 2. Preferred option Consumer NZ supports the mandatory introduction of folic acid forti?cation. As noted in a 2018 report by the Office of the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi, the bene?ts of mandatory forti?cation of packaged bread with folic acid outweigh any potential adverse affects. We support the Ministry for Primary Industries? preferred Option 3b mandatory forti?cation of non?organic wheat flour for bread making purposes. We believe this option balances consumer choice (organic wheat bread and non-wheat varieties will be available) with reducing the incidence of neural tube defects (NTDs). Option 3b would also result in greater health equity, as shown in Australia by a 74 percent decline in the NTD rate for indigenous communities and a 55 percent decline in the NTD rate of teenage mothers. We note this option results in signi?cant set?up costs for flour millers. However, this option has been implemented in Australia and New Zealand millers would be able to gain knowledge from the experience of Australian industry partners. We consider products using forti?ed ?our should include this information in the ingredients list. We would also support small ?boutique? manufacturers being able to apply for an exemption. Consumer NZ does not support Option 3a (mandatory forti?cation of all non-organic bread). This option would limit consumer choice and be very costly for bakeries to comply. We are concerned the implementation costs will be passed on to consumers. We also do not support Option 3c (mandatory forti?cation of all non-organic wheat flour regardless of end purpose). Fortifying wheat flour this way would result in a wide range of products being forti?ed such as cakes, biscuits, and pasta. Consumer choice would be greatly limited because opting out of forti?ed foods would be restricted to organic-only across a wide range of products. Education Regardless of which option is selected, Consumer NZ would like to see increased health promotion and education strategies to promote the increase of folate through diet, supplementation and forti?cation in the target population. If mandatory forti?cation proceeds, we are concerned that women in the target group will think that forti?cation will provide enough folate to prevent NTDs. Education campaigns must be clear that supplementation will still be needed to reach recommended levels. Monitoring and reporting To ensure forti?cation is carried out consistently and is resulting in the expected reduction in the incidence of NTDs, Consumer NZ would like to see monitoring of: . folic acid levels in bread (to ensure consistency of forti?cation levels); . dietary and blood folate levels of the general population and the target group; . monitoring of NTDs including live births, still births and terminations. Thank you for the opportunity to make a submission. If you require any further information, please do not hesitate to contact me. Yours sincerely 621mm Sue Chief executive Submission Form Introduction Folic acid is an essential vitamin important for the heaithy deveiopment of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread . ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposais. Once you have completed this form Email is: While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Dietitians New Zealand (DNZ) or contact person: Contact person: Kath Fouhy (CEO) Submitted on behalf of DNZ. Input provided by Public Health Special Interest Group and Paediatric Special Interest Group Email: Of?cial information Act 1982 Organisation (if appticable): All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act. The problem The number of folic acid-sensitive NTD?affected pregnancies in New Zealand could be reduced if the blood foiate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. Disagree. [3 Unsure. Please explain why: NTDs are a health equity issue in New Zealand, with NTD rates being high for Maori women. Some women may be at a higher risk of having a baby with NTD and may need higher amounts of folate prior to conception and during the first trimester of pregnancy. At the same time, appro?mately half of pregnancies in New Zealand are unplanned, therefore most of these women wilt not be getting enough foiate from their diet and it?s unlikely that they'li be taking a foiic acid supplement until pregnancy recognition in the ?rst trimester. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of heaith outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJ ECTIVE OF THE Agree. Disagree. El Unsure. Please explain why: Folic acid being added to bread ?our is based on the best scienti?c evidence available and this evidence shows no dangerous heaith effects at the level of folic acid that is recommending. Mandatory forti?cation will help to increase the folic acid intake of women of childbearing age, to ensure prevention of NTDs. Forti?cation of a high volume food source such as bread-making flour will heip with reducing health inequalities associated with intake of folic acid in women of childbearing age and pregnanct women, particutariy Maori and Paci?c women. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with MPis assessment but support mandatory folic acid forti?cation due to the limited impact of the status quo on folic acid intake in women under 50 years. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts. cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with assessment but support mandatory folic acid forti?cation due to the limited impact of voluntary forti?cation on folic acid intake in women under 50 years. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. it would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. Disagree. Cl Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory folic acid forti?cation Option based on the modelling and data provided by MPI. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat ?our for bread-making would be forti?ed with folic acid at the flour-milling stage. In general, folic acid is best added late in the process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zeatand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. CI Disagree. El Unsure. Please explain why and provide any evidence you may have: On behaif of Dietitians New Zealand, the Public Heaith and Paediatric Special Interest Groups would like to register our support of mandatory folic acid forti?cation Option 3b. Please see information and references provided in General Comments at the end of the questionnaire. Please atso refer to the submission provided by Rhodi Bulioch and Ctare Wall from the Discipline of Nutrition and Dietetics (The University of Auckland), for further evidence in support. Option Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the forti?cation of all non-organic wheat flour, whether milled in New Zeaiand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory folio acid forti?cation Option 3b based on the lower number of young children exposed to levels of folic acid above the upper limit. Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? This is beyond the scope of our expertise but the proposed approaches to implementation for the three options presented on pages 40 -43 in the discussion paper sounds reasonable. The food industry is better equipped to comment on this. General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. There is enough evidence to suggest New Zealanders? folate levels have already increased under voluntary forti?cation and with mandatory forti?cation, that trend is expected to continue according to the statistical modelling conducted by MPI. Mandatory forti?cation will positively impact the folio acid intake of more New Zealanders than current levels of voluntary forti?cation (Option 1) or enhanced voluntary forti?cation (Option2). Folic acid from forti?ed foods can help some women of child-bearing age meet their nutritional needs as speci?ed by science-based nutrition standards such as the Dietary Reference Intakes. As dietitians in practice, we believe that folic acid forti?cation of commonly consumed foods can be a reliable and effective way to attain health bene?ts by increasing the nutrient intake of a population without relying on individual supplementation practices. We support 3b because forti?cation of the food supply must be moderated to bene?t people who need to increase their nutrient intakes without increasing the risk of excessive intakes to others such as children. As dietitians in practice, we know that increasing folic acid consumption by either dietary selections or supplementation depends on personal behavioural change, food forti?cation with folio acid is therefore an effective way to moderately increase folate intake for the entire population. Women capable of becoming pregnant must use additional folic acid forti?cation sources to meet the recommendations of 400 pg of folio acid (ROI for nompregnant women), in addition to food folate from a varied diet. During pregnancy, the increases to 600119. Folic acid forti?cation offers an additional source of folio acid during the time period critical to the closure of the neural tube, especially in the absence of folio acid supplementation (which is often initiated only at pregnancy recognition). In Australia, it is now mandatory for all wheat flour used for bread making to contain folio acid. Having added folic acid to bread flour means women in Australia have been more likely to reach their recommended intake of Folate. Three slices of forti?ed bread in Australia provide around 120 micrograms of Folic acid which makes meeting the recommendations easily achievable. Mandatory folic acid forti?cation in Australia has improved equity in outcomes (reducing the disparity that existed in rates of NTDs) for young mothers and Indigenous mothers. This could be extrapolated within the New Zealand context. References: 1. 2. Low, F., Beaglehole, Ft, Giuokman, P. (2018). The health bene?ts and risks of folic acid forti?cation of food. Food Standards Australia New Zealand. Proposal P295 Consideration 0f Mandatory Forti?cation With Folic Acid: First Review Report 2007. Catalyst Ltd. A review of compliance with, and enforcement impacts of, the mandatory forti?cation of bread with folio acid and iodine. Christchurch: Catalyst Ltd, 2015. Food Standards Australia New Zealand. Proposal P295: Consideration of mandatory forti?cation with folic acid: Final Assessment Report. 2006. Food Standards Australia New Zealand. Consumers? awareness, attitudes and behaviours towards food forti?cation in Australia and New Zealand. Canberra: FSANZ, 2013. Food Standards Australia New Zealand. Monitoring the Australian population's intake of dietary folio acid before and after mandatory forti?cation. FSANZ, 2016. Maoaldowie A, Hilder L. Neural tube defects in Australia: prevalence before mandatory folic acid forti?cation. Canberra: Australian institute of Health and Welfare; 2011. Brown RD, Langshaw MR. Uhr EJ, et al. The impact of mandatory fortification of ?our with folic acid on the blood folate levels of an Australian population. Med Aust 2011; 194: 65-67. 10 Submission Form Introduction Folic acid is an essential vitamin important for the healthy deveiopment of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand's rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or . introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended ievel, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public wiil help us understand the possible impacts of the proposals. Once you have completed this form Email t0: WM While we prefer emaii, you can aiso post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Dr Hamish McCay, FRACP or contact person: Chair. RACP Aotearoa NZ Paediatric and Chiid Health Division. Organisation (if applicabte): Royal Australasian College of Physacrans Email: a Of?cial information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal detaiis withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial information Act. The problem The number of folic acid-sensitive NTD?affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily fortified with folic acid. This is not enough, however, to sufficiently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. El Unsure. Please explain why: The RACP has consistently advocated for mandatory fortification of flour/bread in New Zealand. The RACP agrees that mandatory fortification wilt be effective in reducing NTD pregnancy rates down from an estimated 10 per 10000 (~64 per year in NZ) to the international ??oor?level" seen in countries with mandatory fortification, such as USA and Canada, of 5-6/10000 This would prevent approximately 30 Neural Tube Defect pregnancies per year. The RACP agrees with the evidence summarised by MPI which suggests the current policy in New Zealand is not increasing folate status adequately for the optimal reduction of NTDs, and agrees with the strong advice to introduce mandatory forti?cation in a 2018 report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. These papers highlighted the weight of international evidence which has been present for a number of years that the greatest reduction in NDTs can only be achieved through mandatory forti?cation. We agree that more than half of all pregnancies in New Zealand are unplanned. Unplanned pregnancies occur more frequently in the more disadvantaged sectors of the community, especially younger women including teenagers, and women in low socioeconomic groups. These women are more likely to have a diet low in naturally folate rich foods and less likely to be taking folic acid supplements. Therefore a public health approach is necessary to reach these women. Maori are disproportionately represented in many adverse health outcomes that re?ect social disadvantage, and we agree with your focus in reducing ethnic disparities in health outcomes. We concur that mandatory forti?cation is likely to reduce disparity in NTD rates, as has occurred in Australia following mandatory forti?cation. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. Ei Disagree. i3 Unsure. Please explain why: This review is very important given the lack of progress in preventing NTDs since the voiuntary regime was put in place in 20?! 2. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE 8 Agree. El Disagree. El Unsure. Please expiain why and provide any evidence you may have: The RACP does NOT support the status quo. We agree with your assessment that such an approach continues to lead to inadequate levels of prevention of NTDs. and fails to address health inequities through social disparities. Option 2: Asking industry to enhance Voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voiuntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from me 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY 3 Agree. El Disagree. CI Unsure. Please explain why and provide any evidence you may have: The RACP does NOT support this option. Industry has been unable to reach the target of 50% in a voluntary regime and is highly unlikely to be able to reach 80% under a further voluntary regime. The time taken to slowly increase percentage of breads fortified over a number of years equates to each year more babies being burn with NTD that were preventable. Option 3a: Mandatory forti?cation of non-organic bread Op?on 3a wouid see bread forti?ed with folic acid at the bread-making stage. it would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zeatand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please exptain why and provide any evidence you may have: The RACP does NOT support this option. Although overall we supports mandatory forti?cation, options 3b and 3c provide a much more effective means of forti?cation. As noted in your report the ability of a very large number of smalt bakeries to implement this change is challenging, there woutd be high compliance costs in monitoring and a high likelihood of great variabitity to the amount of folio acid in forti?ed breads, with a high likelihood many would not actually be fortified effectively. Because of this variability, the heatth gains are likely to be significantly tess than for options 3b and 3c. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat ?our for bread-making would be forti?ed with folic acid at the flour-milling stage. In general, folic acid is best added late in the process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 - 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. l3 Unsure. Please explain why and provide any evidence you may have: The RACP supports this option. It aligns NZ with Australia where substantial health benefits have been documented since mandatory forti?cation was introduced. It is much easier to implement and monitor compared to option 33. it is likely to provide substantial reduction in NTD rates which will bring NZ close to the optima! prevention rate. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option 3c would require the forti?cation of all non?organic wheat ?our, whether milled in New Zeaiand or imported from overseas. The Austraiia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. I3 Unsure. Please explain why and provide any evidence you may have: The RACP also supports option 30. We acknowledge the concern regarding excess folic acid consumption in children with this option. However we would point out that the recommended Upper Limit for Foiic Acid is not based on evidence of actual harm from overdose, but is rather a construct based on normal ranges. Therefore we consider the risk of a proportion of children exceeding the Ui. for folic acid to be a ?teoreticat harm only rather than an actual danger. Option 3c would yield the highest possible ievel of population prevention of NTDs. Implementation provides infon'nation on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO l2! Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? General comments If you have any other general comments or suggestions for the Foiic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. 10 The RACP has consistemly advocated for mandatory forti?cation of bread or ?our for the prevention of We in NZ and in Australia. That advocacy was successful in Australia but was not heeded in NZ The ef?cacy of pro-conceptual folic acid in preventing Neural Tube Defect has been established since the 19805, and the ef?cacy of a public heatth approach, nameiy the mandatory forti?cation of flour to reach the whole population has been proven consistently in international meta-analyses demonstrating a reduction in NTD prevalence following mandatory forti?cation since 2010. The bene?ts of preventing NTD pregnancies through mandatory folic acid forti?cation include reducing the burden of living with spina bi?da to the individual and their family. individuals with Spina Bi?da experience ongoing pain, disrupted home and school life from frequent infections and hospitalisations, physicai limitation, lost opportunities, and stress on their and themselves. Other bene?ts include reducing the grief of perinatal toss of a baby with anencephaly, and reducing the numbers of women who face the agonising decision to terminate a NTD pregnancy. Financial bene?ts of reducing NTD rates include reducing hospital costs of spina bi?da patients, the lost famiiy income, the community, special education and disabitity sector costs for each individual with a neurai tube defact who survives to adulthood. By comparison, the costs of mandatory forti?cation of ftour are minimal, particularly with options 3b and 3c Mandatory forti?cation of bread with foiic acid is safe. It is distressing to consider the impact on very many individuals and families of preventable NTDs since 2007, when NZ withdrew from the trans-Tasm an agreement to fortify with foltc acid. This report makes a strong case for mandatory fortification of flour, and the RACP strongly supports this conclusion and urges resolute action. 11 Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zeaiand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nanciai, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread. or introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended ievel, has any harrnfui health effects. Ail options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possibie impacts of the proposals. Once you have completed this form Email t0: MW While we prefer email, you can also post your submission to: Consultation: Foiic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Di Penny Brandt or contact person: Director Physician Education-Paediatrics. Waikato Hospital Royal Australasian Coilege of Physicians. American Academy of Pediatrics Email: 5 903(3) Organisation (if applicable): Official Information Act 1982 Ail submissions are subject to the Of?cial Information Act and can be released (aiong with personai details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MP1 will consider those reasons when making any assessment for the release of submissions if requested under the Official Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned thus putting those infants at even higher risk of NTD. Some foods are voluntarily fortified with folic acid. This is not enough, however, to sufficiently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. El Unsure. Please explain why: The RACP has consistently advocated for mandatory forti?cation of ?our/bread in New Zealand. The RACP agrees that mandatory forti?cation will be effective in reducing NTD pregnancy rates down from an estimated 10 per 10000 (~64 per year in NZ) to the international ?floor-level" seen in countries with mandatory fortification, such as USA and Canada, of 5-6i'10000 This would prevent approximately 30 Neural Tube Defect pregnancies per year. The RACP agrees with the evidence summarised by which suggests the current policy in New Zealand is not increasing folate status adequately for the optimal reduction of NTDs, and agrees with the strong advice to introduce mandatory fortification in a 2018 report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. These papers highlighted the weight of international evidence which has been present for a number of years that the greatest reduction in NDTs can only be achieved through mandatory forti?cation. We agree that more than half of all pregnancies in New Zealand are unplanned. Unplanned pregnancies occur more frequently in the more disadvantaged sectors of the community, especially younger women including teenagers, and women in low socioeconomic groups. These women are more likely to have a diet low in naturally folate rich foods and less likely to be taking folic acid supplements. Therefore a public health approach is necessary to reach these women. Maori are disproportionately represented in many adverse health outcomes that re?ect social disadvantage, and we agree with your focus in reducing ethnic disparities in health outcomes. We concur that mandatory forti?cation is likely to reduce disparity in NTD rates, as has occurred in Australia following mandatory forti?cation. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. Unsure. Please explainwhy: 3' Ii.? l-r' .tvifn I: 4; Option 1: Maintaining the status quo Option 1 would involve continued votuntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: The RACP does NOT support the status quo- We agree with your assessment that such an approach continues to lead to inadequate levels of prevention of NTDs, and fails to address health inequities through social disparities. Option 2: Asking industry to enhance 1Voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarity increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. I3 Unsure. Please exptain why and provide any evidence you may have: The RACP does NOT support this option. Industry has been unable to reach the target of 50% in a voluntary regime and is highly unlikely to be able to reach 80% under a further voluntary regime. The time taken to slowly increase percentage of breads forti?ed over a nwnber of years equates to each year more babies being born with NTD that were preventable, Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread fortified with folic acid at the bread-making stage. It would apply to all non- organic bread products, and inciude bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: The does NOT support this option. Although overalt we support mandatory forti?cation, options 3b and 3c provide a much more effective means of fortification. As noted in your report the ability of a very iarge number of small bakeries to implement this change is challenging, there would be high compliance costs in monitoring and a high likelihood of great variability in the amount of folic acid in forti?ed breads, with a high likelihood many would not actually be forti?ed effectively. Because of this the health gains are likely to be significantly less than for options 3b and 3c. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, ail non-organic wheat flour for bread-making would be forti?ed with folic acid at the ?our-milling stage. In generat, folio acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with fotio acid (such as rice). Fiour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACIIJ FORTIFICATION OF WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Ci Disagree. El Unsure. Please explain why and provide any evidence you may have: The supports this option. It aligns NZ with Australia where substantiat heatth bene?ts have been documented since mandatory forti?cation was introduced. it is much easier to implement and monitor compared to option 33. it is fikely to provide substantial reduction in NTD rates which will bring NZ close to the optimal prevention rate. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the forti?cation of all non-organic wheat flour, whether milled in New Zea land or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: The RACP also supports option 30. We acknowledge the concern regarding excess folic acid consumption in children with this option. However we would point out that the recommended Upper Limit for Fotic Acid is not based on evidence of actual harm from overdose, but is rather a construct based on normal ranges. Therefore we consider the risk of a proportion of children exceeding the UL for folic acid to be a theoretical harm only rather than an actual danger. Option So would yield the highest possible level of population prevention of NTDs. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE THE APPROACH TO Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the bUsinesses that could be affected, what do you estimate the increased costs to be? General comments If you have any other generai comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper. please let us know. 10 The RACP has consistently advocated for mandatory forti?cation of bread or ?ow for the prevention of NTDs in NZ and in Australia. That advocacy was successful in Australia but was not heeded in NZ The ef?cacy of pro-conceptual folic acid in preventing Neurai Tube Defect has been established since the 19805, and the ef?cacy of a public health approach, namely the mandatory forti?cation of flour to reach the whole population has been proven consistently in international meta-analyses demonstrating a reduction in NTD prevalence foliowing mandatory forti?cation since 2010. The benefits of preventing NTD pregnancies through mandatory folic acid forti?cation include reducing the burden of living with spina bi?da to the individual and their family. Individuals with Spina Bi?da experience ongoing pain, disrupted home and school life from frequent infections and hospitaiisations, physical limitation including paresis, lost opportunities, and stress on their families and themselves. Other bene?ts include reducing the grief of perinatal loss of a baby with anencephaly, and reducing the numbers of women who face the agonising decision to terminate a NTD pregnancy. Financial bene?ts of reducing NTD rates include reducing hospital costs of spina bi?da patients, the lost family income, the community, special education and disability sector costs for each individual with a neural tube defect (NTD) who survives to adulthood. Additional associations with decreased incidence of speci?c types of congenital heart defects and decreased incidence of some cancers are also reported in international literature. By comparison, the costs of mandatory forti?cation of flour are minimal, particularly with options 3b and 3c Mandatory forti?cation of bread with folic acid is safe. It is distressing to consider the impact on very many individuals and families of preventable NTDs since 2007, when NZ withdrew from the trans-Tasman agreement to fortify with folic acid. This MPI report makes a strong case for mandatory forti?cation of ?our, and the RACP strongly supports this conclusion and urges resolute action. 11 Foodstuffs? Foodstuffs (N.Z I Limited Box 38 896 Wellington Mail Centre Lower Hutt 5045 New Zealand 12 November 2019 Folic Acid Fortification Consultation Ministry of Primary Industries Wellington Food.PoIicv@mpi.dovt.nz Folic Acid Fortification Consultation This submission is made on behalf of the Foodstuffs group of companies including Foodstuffs North Island Ltd, Foodstuffs South Island Ltd, and Foodstuffs (Own Brands) which manages Foodstuffs' portfolio of private label brands. Foodstuffs elected to fortify' IS private label branded packaged sliced breads some years ago and 100% of these products are now fortified. Foodstuffs preferred option for folic acid fortification in the future is Option 2: Asking the industry to enhance the volume of bread being fortified. This is a lower cost option than mandatory fortification and preserves a reasonable level of consumer choice, while delivering improved health outcomes. We understand that the main reason government is now considering mandatory fortification is that some packaged bread suppliers have chosen not to fortify their products under the voluntary approach. In first instance we would like to see MPI directly engage with these parties to request they reconsider. We would like to see MPI hold these discussions, and assess the response, before recommending a mandatory approach to fortification. As a measure of goodwill, Foodstuffs (Own Brands) is prepared to extend its voluntary fortification commitment to packaged buns and rolls. If the government ultimately decides that mandatory fortification is necessary, we recommend that officials engage with the flour-millers and bakery ingredient sector, specifically the suppliers of improvers and concentrates, to explore where in the supply chain folic acid is best added to minimise compliance costs and ensure the regime preserves a reasonable level of consumer choice. We accept that officials do not believe consumption of folic acid by the non-target population poses any significant public health risk but we anticipate individual consumers would prefer to retain the option to actively avoid folic acid, without severely restricting their consumption choices, If this is possible to accommodate. We thank officials for considering our point of view. Yours sincerely Melissa Hodd General Manager Government Relations From: Gen Geode 5 Sent: Thursday, 12 December 2019 8:19 PM To: Feed Poiicy Subject: Fortified folic acid in food items Please do some thorough research into the gene mutation before you consider forti?ed food items as folic acid is toxic to those of us with mutations (which about 50% of the population have) Thanks, Gen a From: Sent: Sunday, 10 November 2019 4:27 PM To: Food Policy Subject: Submission on Review of folic acid forti?cation of food Follow Up Flag: Follow up Flag Status: Completed Categories: Transferred to Piritahi Please do not publish my name and contact details. a 9(2an 8 9min) Review of folic acid forti?cation of food I do not agree with the forti?cation of food with folio acid. I recognize the problem that this review is trying to solve but I do not believe that increasing the amount of folic acid in bread will effectively target the population who will bene?t the most. In addition, I object to the assumption that all women of childbearing age intend to have children. Of the options provided in the consultation document. I prefer option 1 - continue with the current voluntary regime which aims to fortify 50% of packa god sliced bread. I do not agree to increasing the amount of folic acid in bread. Women who bear children are a small proportion of the population (when you take into consideration males, and females who are pre- or post- childbearing age or who do not intend to have children). Why should other members of the population have to consume additional medication (folio acid) for no bene?t. Is bread the most effective way to administer folic acid to women who intend to have children? Many women do not eat bread or eat it in small amounts in a bid to reduce the amount of carbohydrates in their diet. Folio acid-forti?ed bread will be no bene?t to these women. Many people are making their own bread in a bid to reduce the amount of plastic in their lives. Folic acid- forti?ed bread will he no bene?t to these women. Young men often eat a lot of bread in one sitting. They may consume large amounts of folic acid-in excess to the recommended dosage. Folio acid-forti?ed bread will be not target the intended recipients and could have unintended side-effects. Ifmost of the population is consuming an excessive amount of folic acid a) what are the potential e?ects on the population and b) what is the effect of excreted unmetabolized folic acid entering waterways? As bread and wheat ?our become more expensive, everyone (including women of child bearing age) will eat less bread. Folio acid-forti?ed bread will be no bene?t to these women. ?All folio acid-forti?ed bread must be more clearly labelled. 1 Regards, Sent: Thursda 7 November 2019 5:52 PM To: Subject FW: - Customer Ca Back Required Interaction ID: 7750791 Hi all, Just to let you know that i also had a consumer enquiry regarding folic acid on Tuesday. Jeremy Tolbert did not want to write a submission to reflect his concerns, so I have captured them here, but I am unsure how we should be taking this into account. Jeremy firstiy stated that his opinion of MPI was very tow which is why he didn?t want to provide a written submission. He doubted our ability to adequately understand the affected industries given the backgrounds of our leadership team. His main issue regarding folic acid as that most bread in New Zeaiand is produced using the Chorleywood method and that we had the highest rate of M08 bakeries. The Chorleywood baking process is one that reduces the time taken to produce bread through high speed mechanical mixing and dough conditioners. His view is that the process which iimits the fermentation/proofing time ieads to issues with: difficulty to digestibility, locking up enzymes. He stated that the type of wheat we grow has led to increased yields bet reduced nutrient content. This has led to conditions such as diabetes and disease. He stated that sourdough bread had 7 times more folic acid than MDB bread. He considered that if we went back to 'real bread? then we would not need to worry about adding folic acid. He considered that we should have warning labels on products produced using the Chorleywood method clue to these issues of the and reduced nutrient content. He considered that the following RNZ podcast covered the issue well and was informative in addition to the Real Bread Society (based in the UK). 11 1'0 ?ammes/thiswa faudiof2128572fln'e rid?matters Cheers PM El From: noreply?telnetcomz Sent: Monday, 4 November 2019 2:53 PM To: MPI Customer Enquiries Centre Cc: MPI Customer Enquiries Centre Subject: MPI Customer Cat! Back Required - Interaction ID: 7750791 HI there. We've received call from 0 customer requiring a call back. 99" Date a. Time lt?qv 2019 02:4? 15M ?rst Name: [Jeremy lost Nome: ?olbert ?11293.? .. memo. Email: 10E EBusiness Name (if applicable): na Caller is upset about the proposed use of folic acid in flour. Contrary to consultation lOverview of customer inquiry: documents he has evidence to show that folic . acid increases the incidences of NTD's. He requests for a call back Kind Regards 9i2tfa) Customer Enquiries Centre - Telnet Tel 0800?008 333 Email: info@mgi.govt.nz El This message contains con?dential information and is for the intended recipient only. If you have any reason to believe that you are not the intended recipient, you are noti?ed that disclosing, copying, distributing or taking any action in reliance on the contents of this information is strictly prohibited. E-mail transmission cannot be guaranteed to be secure or error-free as information could be intercepted, corrupted, lost, destroyed, arrive late or incomplete, or contain viruses. Telnet Services Limited, or the sender therefore do not accept liability for any errors or omissions in the contents of this message, which arise as a result of e-mail transmission. If veri?cation is required please request a hard-copy version. Submission Form introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of N'i?Ds is higher than it could be, and Maori women have higher rates of affected live births than other groups. The financial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread - ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email to: EMPolicmeptgovtn; While we prefer email, you can aiso post your submission to: Consultation: Folic Acid Fortification Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Dr Louise Brough, Dr Janet Weber, Prof Jane Goad or contact person: Nutrition Science Department, School of Food and Advanced Organisation (if applicable): Techn?lOQY Massey University Email: l.brough@massey.ac.nz Official Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MP1 will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial lnforrnation Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced ifthe blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the impedance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD?affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. El Unsure. Please explain why: lntemational research shows the use of folic acid supplements preconception is insuf?cient to prevent NTDs due to the number of unplanned pregnancies. Further, disadvantaged women and some ethnic groups are less likely to use folic acid supplements, even once pregnancy is con?rmed. The current voluntary forti?cation of foods is sporadic, so it is dif?cult for people to actively seek out forti?ed foods. Mandatory forti?cation will help to remove the current inequity in folate status among pregnant women in New Zealand and increase public awareness of the importance of folic acid peri- conceptually. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD?atfected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. El Unsure. Please explain why: increasing foiie acid intake among women who do not know they.r are pregnant is essentiai. it is also important to address the current inequity in foiate status of pregnant women and NTD affected pregnancies in New Zeaiand. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large breed bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. Cl Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment of the status quo: Option 1 is inadequate. The current status gun has been ineffective and has not reduced the number of NTD affected pregnancies since 2009. This method does nothing to address the current inequities, which research has shown to be evident in New Zeaiand. White there is an illusion of ?consumer choice?, most consumers are unware of whether the products they consume are fortified- Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 1. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment of the for?fying 80% of bread; Option 2 is inadequate. Fortifying only 80% of bread wit! be insuf?cient. This will not reduce the in equity we cunently see, and will not enhance active choice by consumers. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 2. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. i3 Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with this assessment- The forti?cation of all non-organic bread will hate to reduce the current inequalities, but there would still be substantial risk of inconsistent fotic acid levels. In addition, it is important for public health policy to address those women who may not consume adequate bread and to actively monitor for overoonsumption in vulnerable groups. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, ail non-organic wheat ?our for bread-making would be fodi?ed with folic acid at the flour-milling stage. in general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts. cost effectiveness, equity. consumer choice, and other impacts on pages 30 34 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: We agree with this assessment. This will help to reduce the current inequalities. in addition. it is important for public health policy to address those women who may not consume adequate bread and to actively monitor for overconsumption in vulnerabie groups. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 30 would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 30 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID 0F NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment. This wouid be our preferred choice, as this would have the maximum effect on reducing inequity. Monitoring impact would be essential. to ensure the forti?cation levels are adequate. In addition, it is important for public health policy to address those women who may not consume adequate bread and to actively monitor for overconsum ption in vulnerable groups. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 5. DO YOU AGREE WITH THE APPROACH TO Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? We agree with this approach to implementation. We also recommend that there is biochemical assessment of folio acid status throughout the popuiation to ensure that the tevels are suf?cient and do not put some of the population at risk of toxicity. Further, there should also be monitoring of vitamin B12 levets in older adults to assess the prevalence of masking of vitamin B12 de?ciency. General comments If you have any other general comments or suggestions for the Fo?c acid fortification: Increasing folic acid availability in bad discussion paper, please let us know. if mandatory forti?cation of bread or flour is brought in within New Zeaiand it is essential that the Ministry of Hearth review the current foiic acid supptement recommended for pregnant women. The current recommendation is for a supplement of 800 moglday for women at tow risk of NTDs. This is much higher than the 400 recommended in other countries (such as USA, UK and Australia). The current upper level of intake is 1000 of folio acid. Thus, the mandatory forti?cation would make this level of intake possibte for some women, and put them at risk of toxicity. It is important that those at increased risk of NTDs, such as obese women, are continued to be targeted by public health initiatives to ensure they continue to consume the recommended dose of supplements. Submission Form Introduction Folic acid is an essentiai vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it couid be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: . 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or . introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended levei, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Emaii to: While we prefer email, you can also post your submission to: Consultation: Folic Acid Fortification Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter 5* Mary-Ann Carter or contact person: Or Qanisation (if applicable): Ministry Of Health Email: Official Information Act 1982 All submissions are subject to the Of?cial lnfonnation Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Official lnfonnation Act. The problem The number of folic acid-sensitive NTD?affected pregnancies in New Zealand could be reduced if the blood fotate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. [3 Disagree. l3 Unsure. Please expiain why: The Ministry of Health agrees with the problem as stated above. For various reasons many women are not able to take the recommended folic acid tablets before and during early pregnancy. Fortification of a dietary staple would considerably reduce the risk NTD affected pregnancies. The lifelong and usuaily serious consequences of NTDs not only affect individuals but also their famiiyhvhanau, and society. Maori and Paci?c people are disproportionately affected. The objective of the review The objective of this review is to increase the of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, white considering consumer choice. increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. Disagree. El Unsure. Piease explain why: The Ministry of Health agrees with the objective of this review. Many countries make forti?cation of some food with folic acid mandatory to reduce the prevalence of NTDs. Australian legislation for the mandatory forti?cation of wheat flour or bread with folic acid came into effect in 2009. In 2016, a report by the Australian Government into the ef?cacy of the mandatory forti?cation scheme showed that it was effective in reducing NTD rates, cost-effective, safe and had the greatest impact in key groups. it also determined that there were no health risks posed by excessive folic acid intake resulting from the introduction of mandatory fortification. If mandatory forti?cation of bread-making flour had occurred in NZ in 2009 when it came into effect in Australia, it is estimated that 134 to 180 pregnancies affected by an NTD could have been prevented over the last ten years. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by iarge bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. Unsure. Please expiain why and provide any evidence you may have: The Ministry agrees with MPl?s assessment. However, it supports mandatory folic acid forti?cation rather than voluntary forti?cation due to the limited health impact (to. no NTDs prevented) of the status quo on folic acid intake in women of reproductive age. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the targe plant bakers) to voiuntariiy increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 ievei of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: The Ministry of Health agrees with MPl?s assessment. However, it supports mandatory folic acid forti?cation due to the limited impact of voluntary forti?cation in women under 50 years. Although this option would reduce the number of NTDs if implemented futiy, based on the current voluntary uptake, it is highly uniikely that industry would get to 80% of bread fortified. This option would also be very difficult to monitor because the number and range of breads forti?ed would change overtime and there would likeiy be huge variation in the amount of folic acid added. Option 3a: Mandatory forti?cation of non-organic bread Option 3a wouid see bread forti?ed with folic acid at the bread-making stage. it would apply to atl non- organic bread products, and inciude bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY IZI Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: The Ministry of Health agrees with MPl?s assessment. However, it supports mandatory folic acid forti?cation Option 3b based on the modelling and data provided by MPI. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 313, all non-organic wheat ?our for bread-making would be forti?ed with folic acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with foiic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 - 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION 0F BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. [3 Disagree. Unsure. Please explain why and provide any evidence you may have: The Ministry of Health agrees with MPl?s assessment and strongly supports mandatory folio acid forti?cation Option 3b based on the modelling and data provided by MPI. Mandatory fortification of alt non-organic breadmaking wheat flour maintains some consumer choice for unforti?ed flour through the availability of organic and non-wheat flours (such as rice or rye). The 2018 report by the Prime Minister's Chief Science Advise: (PMCSA), Professor Sir Peter Gluokman, and the Royai Society Te Aparangi (the Society), to review the health bene?ts and risks of folic acid forti?cation of food concluded that there is compelling evidence that mandatory folic acid forti?cation is associated with lower rates of neural tube defects, and that taking folic acid supplements at the recommended doses in pregnancy has no adverse effects on pregnancy outcome or the child?s health. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option So would require the fortification of all non-organic wheat ?our, whether in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 30 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: The Ministry of Health agrees with MPl's assessment. However, it supports mandatory folic acid forti?cation Option 3b based on the iower number of young children exposed to levels of folic acid above the upper limit. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO El Agree. El Disagree. Ci Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? The implementation and compliance options presented for mandatory forti?cation (Option 3b) by MPI in the discussion paper seem appropriate. However, a faster transition would be preferabie. The Ministry of Health is unable to comment on cost implications; the milling and baking industry would be better equipped to respond to this. General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. The Ministry of Health strongly supports mandatory forti?cation, which has been shown to be effective, cost-effective, safe and equitable. The contribution of folic acid to the prevention of NTDs makes it imperative that New Zealand acts in line with other jurisdictions that have mandated the inclusion of folic acid in ?our. Relieving the inequitabie burden on Maori children and whanau is part of the Government?s obligations under Te Tiriti Waitangi. lf mandatory forti?cation had been implemented in N2 in 2009 as was initially planned, it is estimated there could have been 134 to 330 fewer NTD-affected pregnancies. The effectiveness of mandatory forti?cation is also much easier to monitor and evaluate because there would be a fixed starting point and all eligible foods/ingredients would be forti?ed at the appropriate level. Responsibilities for monitoring need to be clearly defined. Nelson Marlborough a 3* 2 .4: . New Zealand Food Safety's Review of folic acid fortification of food 12 November 2019 For more information please contact: Jane Murray Public Health Service Email: Phone: (03) 543 7805 Introduction 1. Nelson Marlborough Health (Nelson Marlborough District Health Board) (NMH) is a key organisation involved in the health and wellbeing of the people within Te Tau lhu. NMH appreciates the Opportunity to comment from a public health perspective on the New Zealand Food Safety?s Review of folic acid fortification of food. NMH makes this submission in recognition of its responsibilities to improve, promote and protect the health of people and communities under the New Zealand Public Health and Disability Act 2000 and the Health Act 1956. This submission sets out particular matters of interest and concern to the Public Heallh Service, NMH. General Comments 4. NMH welcomes this review of the folic acid fortification of food. Mandatory folic acid fortification is linked to lower rates of birth defects. Providing access to healthy foods plays an important role in academic achievementof students. Lack of adequate consumption of specific foods, such as fruits, vegetables, or dairy products, is associated with lower grades among students.?2 Deficits of specific nutrients vitamins A, B6, 812, C, folate, iron, zinc, and calcium) are associated with lower grades and higher rates of absenteeism and tardiness among students?. Folic acid is an essential vitamin important for the heaithy development of babies early in pregnancy. Taking folic acid supplements at the recommended doses in pregnancy has no adverse effects on pregnancy outcome or the child?s health. Mandatory fortification is in the best interest of the health of the public and will result in the greatest reduction in neurai tube defects and associated health-Ire costs. Mandatory fortification will be the most effective measure to reduce neural tube defect pregnancies. In NZ this is estimated to be a reduction of up to 20% (range is 5-20%) in neural tube defect pregnancies. NZ has one of the highest rates of teenage pregnancy amongst developed countries5; with Pacific and Maori teenagers presenting the highest rates twice the European rate for 1 Kieinman RE, Hall 5, Green H, Korzec?Ramirez D, Patton K, Pagano, ME, Diet, breakfast, and academic performance in children. Annals of Nutrition Metabolism. 2002 ;46(suppl 1 Taras, H. Nutrition and student performance at schooi. Journal of School Health. 3 MacLellan D, Taylor J, Wood K. Food intake and academic performance among adolescents. Canadian .iournai of Dietetic Practice and Research. Neumark-Sztainer D, Story M, Dixon LB, Resnick MD, Blum RW. Correlates of inadequate consumption of dairy products among adoiescents. Journal of Nutrition Education. 5 Ministry of Social Development (NZ). (2019). The Sociai Report 2010. Pacific and more than three times for Maori?. Research has shown that lower socio- economic groups in NZ are more likely to have unplanned pregnancies7 and this group is less likely to understand the importance of folic acid8 and therefore less likely to take folic acid supplements or choose fortified food. 7. Voluntary fortification of any form is therefore likely to be least effective for young mothers, many Maori and Pacific and lower socio-economic groups and is unlikely to achieve the population reduction in the burden of neural tube defects that mandatory fortification is likely to achieve. 8. NMH supports the mandatory fortification of bread however acknowledgement needs to be given that the amount of bread women are consuming is reducing, therefore other measures also need to be considered such as increasing the amount of green leafy vegetables such as siiverbeet, and increasing the amount of lentils anddried beansg. 9. The cost of vegetables have increased in recent years10 making it more difficult for those on lower incomes to afford healthy diets. ln addition to the fortification of bread. consideration needs to be given to making fruit and vegetables more affordable. this could be achieved by removing the GST on fruit and vegetables. Specific Comments 10. NMH agrees with the problem as stated but recommends that the problem statement acknowledges the long term effect neural tube defects (NTD) can have on a child and their families, and that families face many additional burdens in terms of home and car modifications and ongoing medical appointments. 11. NMH agrees with the objective of the review to increase the consumption of food containing folic acid by women of child?being age thereby reducing the number of NTD affected pregnancies. 12. NMH does not believe that the weighting criteria is correct because it does not acknowledge the long term financial burden that is placed on families with a child with NTD. The criteria looks at costs to government and industry but does not factor in costs to families. 13. NMH supports the mandatory fortification of non-organic bread and bread making wheat (Option 30). NMH believes that the goal of any population wide health policy should be the targeted reduction of the health impact on those who experience it the most and therefore in this instance the focus must be on how to best reduce or eliminate NTD '5 Ministry of Social Development (NZ). (2010). ibid. 7 Amin Shokravi. F..Howden Chapman. Ph.. Peyman N. (2009). op. cit. p. 2 3 Ministry for Primary industries. (2012}. op. cit. 5 9 135:}! octcr.co. article 1? overali, and in particularfor Maori whanau. therefore NMH supports Option 3:3. The consultation document shows that Option 3c modelling demonstrated significantly improved health benefits than Option 3b. 14. NMH supports the Australia New Zealand Food Standards Code to continue to permit voluntary fortification of folic acid in other foods such as breakfast cereals. Conclusion 15. NMH thanks the New Zealand Food Safety for the opportunity to comment on the Review of folio acid fortification of food. Yours sincerely Peter Bramley Chief Executive New Zealand 0 College of Midwives 0 TE KARETI NGA KAIWHAKAWHANAU KI AOTEAROA 12th November 2019 Folic Acid Fortification New Zealand College of Midwives PO Box 21 206 Christchurch 8143 Tel (03) 377 2732 The New Zealand College of Midwives is the professional organisation for midwifery. Our members are employed and self-employed and collectively represent over 90% of the practising midwives in this country. There are approximately 3,000 midwives who hold an Annual Practising Certificate (APC). These midwives provide maternity care to, on average, 60,000 women and babies each year. New Zealand has a unique and efficient maternity service model which centres care around the needs of the woman and her baby. Midwives undertake a four-year equivalent undergraduate degree to become registered followed by a ?rst year of practice program that includes full mentoring by senior midwives. The undergraduate curriculum meets all international regulatory and education standards. Midwives are authorised prescribers in relation to their Scope of Practice as determined by the Midwifery Council. Midwives provide an accessible and primary health care service for women in the community within a continuity of carer model as Lead Maternity Carers. Midwives can also choose to work within secondary and tertiary maternity facilities, providing essential care to women with complex maternity needs. The College offers information, education and advice to women, midwives, district health boards, health and social service agencies and the Ministry of Health regarding midwifery and maternity issues. Midwives interface with a multitude of other health professionals and agencies to support women to achieve the optimum outcome for their pregnancies, health and wellbeing 376 Manchester Street! PO Box 21106 Edgeware Christchurch ITelephone (03) 377 2732 I Facsimile (03) 377 5662 1' Email nzcom@nzcom.org.nz New Zealand 0 College of Midwives 0 TE KARETI NGA KAIWHAKAWHANAU KI ADTEAROA 12'h November Ministry for Primary Industries (MPI) Food.Policy@mpi.govt.nz Folic Acid Fortification The New Zealand College of Midwives (the College) welcomes the opportunity to provide feedback on the proposed options for folic acid forti?cation consultation process. Provision of pre-conceptual care to women is within the midwifery scope of practice and midwives currently advise women to take folic acid supplementation pre-conceptually and in the ?rst trimester of pregnancy in order to reduce the risk of neural tube defects. Because neural tube defects occur very early on in pregnancy, mandatory forti?cation is largely aimed at those women who are unaware of their early pregnancies. Not all women will be consuming products made with forti?ed ?our, and even with supplements and forti?cation the incidence of NTDs will not be eliminated completely. However, mandatory forti?cation may have a signi?cant impact on the reduction of rates of NTDs and the College agrees that this is an effective public health strategy which we can support. The College feedback is below. Although we generally support mandatory forti?cation we have raised some questions in this feedback. 1. Mandatory forti?cation is likely to provide major bene?ts to populations who may be less likely to use supplements. In terms of addressing health inequities the College would like to see more work in the area of public health regarding supplements and, more speci?cally, consultation with Maori and Pasi?ka communities about experiences of the barriers to using these recommended supplements. It is necessary to develop a well-designed and systematic programme to inform the public and promote supplements which will prevent more NCDs than food forti?cation. 376 Manchester Street I PO Box 21106 Edgeware Christchurch [Telephone (03) 377 2732/ Facsimile (03) 377 5662 I Email nzcom@nzcom.org.nz 2. Although the College generally supports mandatory forti?cation we have some concerns about the potential for exceeding the recommended dosage of folic acid. Points 3-7 below represent relevant research we have noted in this area. 3. Schrott et al. question whether there could be unintended consequences of continuing folic acid supplementation on outcomes in children and they suggest that children born to women who received extended folic acid supplementation should be followed in terms of their cognitive and social development.1 4. Caffrey et al. looked at gene speci?c DNA methylation in newborns in a study that aimed to investigate the effect of folic acid supplementation during trimesters two and three on DNA methylation in cord blood of key epigenetically controlled genes. The RCT study presented evidence that continued folic acid supplementation after the ?rst trimester of pregnancy affected DNA methylation of speci?c genes in the including those related to the brain.2 5. Schrott et al. also suggest that we do not fully understand the consequences of population- level forti?cation from food-enrichment programs, and that there is ?con?icting evidence about the role that increased folic acid supplementation plays in colon cancer risk, which may be particularly relevant given the potential for reduced DNA methylation in an excess of folate.? 6. If mandatory folic acid forti?cation goes ahead the College would like to see independent monitoring and surveillance mechanisms put into place, which assess the potential risks and bene?ts associated with mandatory forti?cation. Without this monitoring an evaluation of the consequences of this change will not be possible. 7. Although Schrott et al. and Caffrey et al. are concerned with supplementation dosages in pregnancy after the ?rst trimester, rather than the amounts likely to be received through food forti?cation, the College is interested in understanding this issue in more depth and would welcome further information related to this point. 8. The College notes that a supplement of 400pg/day of folic acid appears to provide continued bene?t of reduced incidence of NTD whilst also protecting against the risk of exceeding recommended upper intake levels.3 4 5 1 Schrott, R., Murphy, 8. K. (2018). Folic acid throughout pregnancy: too much? Am Clin Nutr, 2 Caffrey, A., Irwin, R. E., McNulty, H., Strain, J. J., Lees-Murdock, D. J., McNulty, B. A., Ward, M., Walsk, C. P., Pentieva, K. (2018). Gene-speci?c DNA methylation in newborns in response to folic acid supplementation during the second and third trimesters of pregnancy: epigenetic analysis from a randomized controlled trial. The American Joumal of Clinical Nutrition, 3 Capel, Corcoy, R. (2007). What Dose of Folic Acid Should Be Used for Pregnant Diabetic Women? Diabetes Care, 30 (7) e63; DOI: 4 Chitayat, D., Matsui, D., Amitai, Y., Kennedy, 0., Vohra, S., Rieder, M., Koren, G. (2016). Folic acid supplementation for pregnant women and those planning pregnancy. Journal of Clinical Pharmacology, 5 De-Regil, L., Pe?a?Rosas, J., Femandez-Gaxiola, A. C., RayooSolon, P. (2015). Effects and safety of pertconoeplional oral folate supplementation for preventing birth defects. Cochrane Database of Systematic Reviews, Issue 12. Art. No.: 00007950. DOI: 10.1002/14651858.CD007950.pub3 376 Manchester Streetl PO Box 21106 Edgeware Christchurch Telephone (03) 377 2732 Facsimile (03) 377 5662/ Email nzcom@nzcom.org.nz 9. The College also notes that other countries recommend a dosage of 400ug/day. 5 7 3 Therefore, we suggest that this work on the forti?cation of food with folic acid should be accompanied by a review of the recommended supplemental dosage of 800 pg [day as part of pre?conceptual care, and for pregnant women in the ?rst trimester, in Aotearoa New Zealand. This will require an urgent review of the dosage of funded tablets. 10. The College considers that mandatory labelling of forti?ed products is essential and we support the exclusion of organic foods from the mandatory regulations. Conclusion The College generally supports the mandatory forti?cation of all non-organic wheat ?our, whether milled in Aotearoa New Zealand or imported from overseas. Our accompanying concerns have been outlined in the points above. If mandatory folic acid forti?cation goes ahead, independent monitoring and surveillance mechanisms to assess the associated potential risks and bene?ts will be essential. Regardless of the option chosen, information needs to be well communicated to the public and also to health professionals who provide care to pregnant women. If the status quo is maintained and the voluntary forti?cation option is chosen, there will be a need for public health strategies to raise awareness of dietary sources of folic acid, and the importance of folic acid consumption as a means of reducing the rates of neural tube defects. Nga mihi Carol Bartle Policy Analyst New Zealand College of Midwives 5 Centers for Disease Control and Prevention 7 NHS UK 8 Government of Canada 376 Manchester Street! PO Box 21106 Edgeware Christchurch I Telephone (03) 377 2732 I Facsimile (03) 377 5662/ Email nzcom@nzcom.org.nz Submission re: . Folic Acid Fortification: increasing folic acid availability in food. Discussion Paper no: 2019/08 From New Zealand Flour Millers Association New Zealand Association of Bakers Inc. 12 November 2019 Via email to Submission re: Folic Acid Fortification: increasing folic acid availability in food. Discussion Paper no: 2019l08 This submission is made by the New Zealand Flour Millers Association (NZFMA) and the New Zealand Association of Bakers Inc. (NZAB). INTRODUCTION The NZFMA is comprised of the following flour milling organisations: 0 Champion Flour Milling (operates 3 mills 2 on the port of Tauranga and 1 in Christchurch) - George Weston Foods Mauri (operates 3 mills 1 in Auckland, 1 in Wellington and 1 in Christchurch) 0 NZ Flour Mills (Tirau) 0 Farmers Mill (Timaru) The NZ flour and wheat industry was de-regulated in 1987 with the NZ flour milling industry remaining to operate in an open and competitive free market environment. Fiourmills in NZ have become increasingly efficient and more automated. Through extensive capital investment in unique and diverse processing methods for specific end market use, flour miliers must be highly skilled to adapt to the challenges of not only the domestic market requirements, but also the export sector. The future outlook for the industry is a stable and secure market with growth opportunities influenced by research and development into ensuring innovative new products derived from cereal and flour based products, dietary trends and consumer education in maintaining the nutritional importance of cereal based foods in the daily diet. NZAB members are the large plant bread bakers, who bake for wholesale, bread requiring the use of 10 metric tonnes or more of flour per week. The following baking companies are members: ARYZTA - Breadcraft (Wai) Couplands Bakeries George Weston Foods (NZ) Limited - Goodman Fielder NZ - Walter Findlay Yarrows (The Bakers) As a group, NZAB member companies are currently fortifying approximately 46% by volume of packaged sliced bread they produce under a voluntary code of practice agreed with the Ministry for Primary Industries in 2012. NZAB has no plans to voluntarily fortify more than 50% by volume. The New Zealand bread market as serviced by plant bakers is in decline approximately 3% versus a year ago. While bread provides a good source of protein, vitamins, minerals, fibre and carbohydrates the opinion that it is ?highly processed' is the number 1 barrier to bread consumption. in 2018, a NZ usage and attitude study revealed the top four barriers to bread consumption to be (in this order) 1. too processed 2 too much sugar 3. to reduce carbs 4 unheahhy Potentially added fortification would only increase the 'highly processed' barrier, so there might be unintended consequences, including further decline. For this reason the industry is keen to remain in a position that allows it to promote it?s products as natural, and nutritious, including the choice of bread with and without folic acid. Fortification of foods and ingredients can help prevent deficiency diseases, improve nutritional status and promote the overall health of populations. The NZ flour milling and baking industries recognise this and are prepared to work with Government to ensure the best outcome for New Zealanders. PREFERRED OPTION FOR FORTIFICATION 0F BREAD WITH FOLIC ACID Bread is a natural, basic food product and we would prefer to keep it that way, and/or at least to provide plenty of options for consumers whether their product of choice is fortified or non-fortified. We also do not want to be put in the position where the bread market declines further due to consumers seeking alternative carbohydrate sources in order to avoid fortified product. For these reasons we prefer option of status quo, voluntary fortification, and NZAB do not plan to voluntarily fortify more than 50% by volume of production. MANDATORY FORTIFICATION At the same time as preferring voluntary fortification, if this is to be changed to mandatory fortification (in recognition of the health benefits to the public) then we would prefer that this be by way of fortification of improver/ other ingredient cir flour; and will assess best way to do this as an industry in consultation with MPI. Mandatory fortification of all bread should cover both plant and craft or small bakery products and avoid the risk of insufficient uptake and/or dropping out of any voluntary scheme. Preferred mandatory option is 3b. Mandatory fortification of bread flour, although would like to extend this option to include considering mandatory fortification of other bread ingredients dough improvers Forti?cation of Bread Flour 0 While flour is the ingredient of choice for mandatory fortification in other countries, it is a more expensive option for the flour millers in NZ as equipment for micro dosing, and storage facilities to separate fortified from un fortified products is not already in place in NZ as it was in Australia, for example, before implementation of mandatory fortification with folic acid. 0 In some cases NZ Mills are also constrained by physical space, so may not have room to install extra storage silos required to prevent cross contamination of non-fortified with fortified product. Fortification of flour with Folic Acid at the target rate of 3g/1,000 kg of flour is considered difficult to achieve on a consistent and accurate basis. Flour mills in NZ produce flour at manufacturing rates of between 5,000 kg to 10,000kg per hour, accurate micro feeding of Folic Acid to flour will require levels of between 15g to 30g per hour to be dosed into the flour. Mandatory addition of Folic Acid to bread making flour will result in the following flours (generally all baking flours) that are milled by NZ flour mills being fortified: 0 All self-rising, wholemeal and bakers? flours (from medium to high protein), pack sizes will be from 10kg up. 0 All retail flours which include standard, high grade, self?rising and wholemeal flour, pack sizes will be from 1.25kg up to 5kg. It is anticipated that there will be other baked products that due to the universal use of flours for baking general use flours) will be voluntary fortified with Folic Acid. This includes (and is not limited to) baked products such as biscuits, cakes, pizza?s, pastry, quick service restaurant products. Confirmation of agreement to these market uses of bread making flours will mean less constraint (and cost) by flour mills in having to segregate flours by market requirement and/or by either fortified/non?fortified flour type. Any requirement for segregation of a particular flour type into fortified and non?fortified variants may result in flour mills constructing more flour silos which for some organisations is a constraint due to land availability. To achieve these fortification goals, the industry's efforts must be guided and supported by regulatory agencies. Flour fortification programs will include appropriate Quality Assurance and Quality Control programs at each mill. If directed to implement option 3b, the NZ flour milling industry will seek funding assistance from Government to install the necessary capital equipment required for fortification of Folic Acid to flour and agree on an appropriate timeline for implementation. Given extra requirement for capital works to be able to implement fortification it may take longer for NZ industry to implement than it did Australia more than 2 years from notification of requirement to fortify). It is also worth noting that fortification with folic acid is a cost regardless of how it is achieved as there is a cost for the folic acid itself plus a cost of addition be that at the mill in the flour, in any other ingredient used, or at the bakery. Due to cost pressures on bakeries this increased cost will most likely be passed on to consumers. Fortification of dough improvers We considerthe option of mandatory fortification of dough improvers (including bread concentrates and premixes containing improvers) worth investigating. Points we consider may be in favour of selecting the bread dough improver option (and have yet to be proven) are as follows: 0 Accurate closing 0 lmprover manufacturers are already dealing with micro ingredients 0 improvers are added to doughs as a percentage of total cereal rather than a percentage of flour - improvers are a functional ingredient used by the majority of Bakers, not an extra ingredient premix) which may or may not be added as only has functionality of carrier for folic acid 0 Opportunity to have bread specific fortification not carried over into biscuits, pizzas, retail packs of general flour etc. 0 Will cover bulk of bread volume (estimated 80 while increasing consumer choice artisan products which do not contain dough improvers will not be fortified Proven method of folic acid fortification, already used by some bakeries - Potentially faster to implement than fortification of flour REQUESTED NEXT STEP Under a mandatory requirement to fortify bread with folate we agree that mandatory fortification of a bread ingredient is the best way forward. We would appreciate the opportunity to work with to compare fortification of Bread Flour versus Dough lmprovers, from a health impact, cost effectiveness, equity and consumer choice perspectives. We anticipate that we will be able to provide all information required by MPI to consider the dough improver option by end of November 2019. This will allow mandatory fortification of bread dough improvers to be considered against the other options for extending folic acid fortification. In the meantime NZFMA are obtaining quotes to be able to exactly define the cost of implementing fortification of flour. This work will be completed by end of February 2020 at the latest. Thank you for considering our position. If you require further information or clarification please contact admin@bakingresearch.org.nz in the first instance. )fgm grace COUNCIL 12 November 2019 Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 WELLINGTON 6104 1 Email: food.policv@mpi.qovt.nz Dear Sir/Madam Attached are the comments that the New Zealand Food Grocery Council wishes to present on Folic acid forti?cation: Increasing folic acid in food New Zealand Food Safety Discussion Paper October220 1?9. Yours sincerely was 21:1,? Katherine Rich Chief Executive 99-105 Customhouse Quay, Wellington, PO Box 25-420, Wellington 6146, NEW ZEALAND 13f? NEW [groceryas COUNCIL we Folic acid fortification: Increasing 'folic acid availability in food New Zealand Food Safety Discussion Paper No:2019/08 r5? j. Submission by the New Zealand Food Grocery Council ,2 12 November 2019 NEW ZEALAND FOOD GROCERY COUNCIL 1. The New Zealand Food Grocery Council welcomes the opportunity to comment on the Folic acid forti?cation: Increasing folic acid availability in food New Zealand Food Safety Discussion Paper No:2019/08 October 2019 (the Discussion Papen. represents the major manufacturers and suppliers of food, beverage and grocery products in New Zealand. This sector generates over $34 billion in the New Zealand domestic retail food, beverage and grocery products market, and over $31 billion in export revenue from exports to 195 countries some 72% of total merchandise exports. Food and beverage manufacturing is the largest manufacturing sector in New Zealand, representing 44% of total manufacturing income. Our members directly or indirectly employ more than 400,000 people one in ?ve of the workforce. OVERARCHING COMMENTS 3. is cautious about supporting a mandatory folic acid forti?cation programme and asks of?cials and decision makers to consider fully the potential effects of a forti?cation programme that purposely and knowingly results in child over-consumption. In relation to health impacts, the key concerns are the impact of: . over-consumption by children 1 to 8 years old; . the interaction of folic acid and 812; and the circulation of unmetabolized folic acid. With recent research and inquiry developments in major countries particularly Australia and the US, on the health impacts of folic acid forti?cation, we strongly believe application of the precautionary principle be applied in terms of timing of implementation especially in relation to the US National Institute of Health (NIH) review. There are health-related mitigation measures that could be taken that would support: . Adding B12 forti?cation at the same time as folic acid fortification in view of evidence from like countries . Using in order to avoid problems associated with circulating unmetabolised folic acid. is a natural substance is commercially available and could be added to ?our . Assess the impact of overconsumption by children aged 1 to 5 years and factor this into the decision . Defer implementation until the US NIH review report has been published. Our primary support is for continued voluntary fortification as an interim measure until the issues related to health impacts are better addressed. We could then support a mandatory system that was implemented in the most cost-ef?cient way, taking account of removing duplication across businesses and minimising the cost to them and other means of fortifying bread than to bread-making ?our if that is more cost-effective. DETAILED COMMENTS Neural tube defects and folic acid 6. recognises that neural tube defects (NTDs) affect. In the March 2018 year, there were over 73,000 pregnancies (comprising around 60,000 live births, 200 still births and 13,000 abortions) in New Zealand of which 64 were pregnancies affected by NTDs We are advised that some of these NTDs will also be insensitive to folate or folic acid. This is a quite Page 2 rare occurrence but one which we know has costs even while not all the affected pregnancies result in live births to the families, whanau, the community and New Zealand generally. The problem and voluntary fortification to date 7. There is little dispute that fortification of food with folic acid could reduce the number of NTD affected pregnancies. The issues have been safety for the population not needing folic acid fortification, choice of food to fortify, ef?cacy, cost and consumer choice. Voluntary forti?cation of bread was widely negotiated with the New Zealand bread industry in 2009. On average, around 38% of non-organic, packaged sliced breads are fortified. According to the Discussion Paper, this approach is not increasing ?folate status adequately for the optimal reduction of suggests over 80 countries mandate folic acid forti?cation, the closest example being Australia which recorded a 1.5% decrease in NTD rates over a period of three years. Health risks 9. 10. 11. 12. The key health risk, not covered in the Discussion paper but covered in supporting documentation, is over?consumption by non-target population groups, most New Zealanders. Two other health risks not covered in the Discussion Paper and difficuit to locate in other consultation documentation relates to the interaction of a high folate status and low vitamin B12 with respect to cognitive function and the impact of unmetabolised folic acid circulating in the blood. Over-consumption Over-consumption by a non-target population group increases with each option from none for the status quo to 5-36% for the option of fortifying all ?our. This is of concern since the discussion Paper states that there is no conclusive evidence that folic acid in the amount recommended for forti?cation purposes has any harmful effects on health?. The potential over-consumption is only referred to for 5 to 8 year olds not younger. Evidence is emerging of harm. The question is when is it conclusive and should we apply caution in the interim. This and other health risks were considered by the US in August 2019. It would be sensible and responsible to consider the report of that enquiry before proceeding. interaction of a high status and low vitamin B12 There has been concern of folic acid consumption masking the neurological consequences of B12 de?ciency but that generally the phenomenon does not occur at the level of forti?cation generally applied. The emerging issue is the interaction of a high folate status and low vitamin 812 status concerning the increased risk of cognitive impairment in the elderly. This issue is not mentioned in the Discussion Paper and the supporting document (p10) states that the Prime Minister?s Chief Science Advisor?s report prepared in 2017 found no evidence to link the use of folic acid supplements orforti?cation to increased risks of neurological [cognitive However, several papers have raised this (Morris et ai 2007, Moore et al 2014, Castillo-Lacellotti et al 2015) including in Australia. While this is only from three countries, they are most likely to have the resources to monitor and research impacts. Caution is therefore suggested. The signi?cance of these findings is that those at risk have biomarkers indicating that it is interaction rather than masking that is the problem with B12. At a potential rate of around 4% of a growing population of elderly, a solution is to fortify with B12 as well. impact of unmetabolised folic acid circulatinq in the blood The supporting document does not consider unmetabolised folic acid circulating in the blood as an issue and the Discussion Paper does not mention it. After fortification in the USA, folic acid has found in the serum of more than 95% of a sample of nearly 3,000 people between 1 and 60 years old (Pfeiffer et al 2015). There is evidence of possible harm Page 3 associated with unmetabolised folic acid from several other studies, (eg Paniz et al 2017) which suggest that folic acid that involves circulating unmetabolised folic acid harms the nervous system. We note a solution for this in the concluding paragraphs. Options for future 13. 14. 15. 16. 17. 18 19. 20. 21. 22. The Discussion Paper sets out three broad options for increasing folic acid in the food supply (1. Status quo; 2 Enhanced voluntary forti?cation; and 3 Mandatory forti?cation) and a further three options for mandatory fortification (3a non-organic bread; 3b non-organic bread making flour; 3c all non-organic wheat ?our). Option 1. Status duo Folic acid would continue to be added to bread at the bakery stage and while delivering no increase in NTD rate, there is no appreciable reduction. The industry has committed to voluntarily fortify to 50% but a rate of 80% is needed to deliver an NTD reduction. There is no over-consumption under this option. recognises that while there has been an impact from voluntary forti?cation, uptake has been slow. Option 2 Enhanced voluntary forti?cation Folic acid would continue to be added to bread at the bakery stage but the industry would be asked (tasked) to commit to increasing the voluntarily fortification to 80%. At this rate, an NTD reduction would result. Although the risk of over-consumption is not identi?ed under the ?health impacts? of this option in the Discussion Paper, it was presented at public consultations as around 1-2% of children aged 5-8 would exceed the Upper Limit (UL). notes that the need to more than double voluntary forti?cation is a substantial commitment that may not be reached even over the next decade. The additional cost to industry would be around $100k per year. The most important consideration is the over-?consumption. . On balance, considers the over-consumption low on the way to the target level, the additional cost is low but that the likelihood of achieving the 80% threshold is perhaps also low. Option 3 Mandatory forti?cation All mandatory options have higher levels of over-consumption by a non?target population group, deliver greater prospects of NTD reduction, limit consumer choice and cost more for industry. Option 33 Mandatory fortification of non-oroanic bread This Option proposes the mandatory fortification of all non-organic bread. Around 1-6% of children aged 5-8 years old would exceed the Upper Limit (UL) but there would be greater prospects of NTD reduction. Consumer choice would be reduced (over the status quo) and the cost for industry would be substantially higher. Each large bread manufacturer participating, has to date, worked out its own method of forti?cation meaning that systems to fortify have to be duplicated in each facility. is uncomfortable with the level of overconsumption by 5-8 year olds and very concerned at the prospect of younger children being even more exposed to exceeding the UL. This latter issue is not covered in the Discussion Paper. Page 4 23. 24. 25. 26. 27. Option 3b Mandatory forti?cation of non-orqanic bread ma_k_inq ?our This Option proposes the mandatory forti?cation of all bread-making ?our. A little less than 1-6% of children aged 5-8 would exceed the Upper Limit (UL) under this Option but there would be greater prospects of NTD reduction. Consumer choice would be reduced (over the status quo) and the cost for industry could be less than for Option 33 since only the bread-making flour supplier would be required to fortify. remains uncomfortable with the level of overconsumption by 5-8 year olds and very concerned at the prospect of younger children being even more exposed to exceeding the UL and considers these should be re-considered. Delivering the forti?cant effectively by the bread-making supplier would provide relief from setting up individual systems by SMEs. This could be through the ?our or another bread ingredient depending on cost-effectiveness. Option 3c Mandatory forti?cation of all non-croonic wheat floor This Option proposes the mandatory forti?cation of all non-organic wheat ?our. A much greater percentage of children aged 5-8 years old would exceed the Upper Limit (UL) under this Option but there would be a signi?cant and positive change in the prospects of NTD reduction. does not support an option that purposely sets out to raise the consumption of folic acid of non-target groups. is very uncomfortable with the level of overconsumption by 5-8 year olds and very concerned at the prospect of younger children being even more exposed to exceeding the UL. We understand that ultimately this is a decision for of?cials and the Government, but we do ask that both consider this issue separately and in detail parents and grandparents in particular will want to be assured that Government ministers have considered all available science and evidential trends. Conclusion 28. 29. has two key concerns health and cost. We consider that more summary health impacts might have been brought forward into the Discussion Paper for ease of consideration. However, in relation to health, the key concerns are the impact of: over-consumption by children 1 to 8 years old; a the interaction of folic acid and 312; and . the circulation of unmetabolized folic acid. \Nlth recent research and inquiry developments in major countries particularly Australia and the US, on the health impacts of folic acid forti?cation, we strongly believe application of the precautionary principle be applied in terms of timing of implementation eSpecially the in relation to the US NIH review. There are also mitigation measures that could be taken that would support: 0 Adding B12 forti?cation at the same time as folic acid forti?cation in view of evidence from like countries . Using in order to avoid problems associated with circulating unmetabolised folic acid. is a natural substance is commercially available and could be added to ?our . Assess the impact of overconsumption by children aged 1 to 5 years and factor this into the decision . Defer implementation until the US NIH review report has been published. Page 5 References Castillo-Lancelotti C, Margozzini P, Valdivia G, Padilla O, R, Rozowski J, Tur JA (2015). Serum folate, vitamin B12 and cognitive impairment in Chilean older adults. Public Health Nutr 2015; Doi: 10.1017/31368980014003206. Moore E, Ames D, Mander A, Came R, Brodaty H, Woodward M, Boundy K, Ellis K, Bush A, Faux N, et al (2014). Among vitamin B12 de?cient older people, high folate levels are associated with worse cognitive function: combined data from three cohorts. Alzheimers Dis Doi: 10.3233ljad-131265. Morris MS, Jacques PF, Rosenburg IH, Selhub (2007). Folate and vitamin B-12 status in relation to anemia, macrocytosis, and cognitive impairment in older Americans in the age of folic acid forti?cation. Am Clin Nutr 2007; Doi: Morris MS, Jacques PF, Rosenberg IH, Selhub (2010). Circulating unmetabolized folic acid and in relation to anemia, macrocytosis and cognitive test performance in Americanm seniors. Am Clin Nutr 2010: 91:1733-44. Doi: 10.3945/ajcn.2009.28671. Paniz Bertinato JF, Lucena MR, De Carli Amorim P, Gomes GW, Palchetti CZ, Figueiredo MS, Pfeiffer CM, Fazili Z, et al (2017). A daily dose of 5mg folic acid for 90 days is associated with increased serum unmetabolized folic acid and reduced Natural Killer Cell cytotoxicity in healthy Brazilian adults. Nutr 2017; Doi: 10.3945/jn.117.247445. Pfeiffer CM, Sternberg MR, Fazili Z, Yetley EA, Lacher DA, Bailey RI, Johnson CL (2015). Unmetabolized folic acid is detected in nearly all serum samples from US children, adolescents and adults. Nutr 2015; Doi: 10.3945/jn.114.201210. Page 6 NEW ZEALAND NURSES ORGAN TOPUTANGA 2019-111001 TAPU HI KAITEAKI 0 ACT EA RDA 11 November 2019 Ministry for Primary Industries PO Box 2526 WELLINGTON 6104 By email: Food.Policy@mpi.govt.nz T?na koe Review of folic acid fortification of food The New Zealand Nurses Organisation Toputanga Tapuhi Kaitiaki Aoteaoroa (NZNO) welcomes the opportunity to make a submission to the Ministry for Primary Industries (MPI) on the New Zealand Food Safety Discussion Paper No: 2019/08: Folic acid fortification of food: Increasing folic acid availability in food. NZNO is the largest health professional workforce voice in Aotearoa New Zealand, with over 51,000 members and contributes to improvements in the health status and outcomes of all people through influencing health, employment and social policy development. NZNO aims to represent the main issues and concerns of its members and has consulted all colleges and sections in preparation of this submission. As nurses we are directly involved in working with children and adults with potentially avoidable Neural Tube Defects (NTDs), such as spina bifida and anencephaly. We observe these individuals living with chronic pain and disability, the impact on their whanau and the preventable costs of multiple surgeries, medical, educational and social support required for them. NZNO strongly supports Option 3, mandatory fortification of all non-organic: bread; wheat flour for bread-making purposes; or wheat ?our and recommends the government acts swiftly to introduce this measure. We are of the view that the imperative for the government to implement compulsory fortification is overwhelming. Failure to do so would be a missed opportunity to prevent babies being born with NTDs. NZNO members are very concerned that NTDs effect on average 64 pregnancies each year in Aotearoa New Zealand and estimates show that mandatory fortification has been anticipated to be able to prevent up to 24 cases per year.i This is our third submission supporting the mandatory fortification of bread with folic acid; previous submissions were submitted in 2009 and 2012. UIECB Level 3 Crows Horwath House 57 Willis Street Wellington 601 1 PO Box 2128 Wellington 6140 0800 28 38 48 NZNO is of the view that while fortification does not achieve full protection, it provides a useful population safety net that contributes to the overall preventative effect. We wish to highlight that fortification will not cover all segments of the population, for example, people with Coeliac disease who cannot eat products containing wheat, barley or rye. However, recent research points to the importance of a population safety net in Aotearoa New Zealand. A recent study showed that of an estimated 95,335 pregnancies in 2008, more than half were unplanned.ii Given the extent of unplanned pregnancy, many women will not have taken folic acid around the time of conception and very early in their pregnancy, when folic acid is most effective. Another study showed that although most New Zealand women had heard of the need for folic acid supplements. only one-third of women consumed folic acid supplements prior to NZNO also notes that the move to introduce mandatory folic acid forti?cation would put Aotearoa New Zealand in line with other countries. We observe that internationally 81 countries have introduced mandatory folic acid fortification in food, including Australia, Canada and the US. Notably, all studies of the consequences of fortification have shown a clear reduction in the incidence of Crucially, mandatory folic acid fortification offers great potential to reduce health inequalities in Aoteaora New Zealand. Food fortification benefits members of the population less likely to use supplements and be at risk of having a baby with a NTD. It has been shown that health education initiatives designed to address folic acid supplement use in at risk subgroups have been met with little success. Data shows that when pregnancy is planned, periconception supplement use is less common among Maori, Pacific and Asian women, younger women and women with lower education and income." This inequity in use of supplements is reflected in data on NTDs, with a socioeconomic gradient and a higher risk among Maori women than those of non-Maori non- Pacific ethnicity (RR 2.65, Research also shows that bread consumption is higher among those with low income and the least education. However, the current system of voluntary fortification in Aotearoa New Zealand (since May 2014) does not fully allow inequalities to be remedied as breads voluntarily fortified with folic acid are typically wholegrain, which are generally more expensive and less likely consumed by those women of lower socioeconomic status.Vii NZNO members are of the view that the benefits of mandatory fortification outweigh any risks. The strong advice to introduce mandatory fortification given in a 2018 report by Prime Minister's Chief Science Advisor and the Royal Society Te Aparangi underpins our position. This report shows that there is no conclusive evidence that folic acid in the amount recommended for fortification purposes has any harmful effects on health, such as cancer diabetes, heart attacks or cognitive New Zealand Nurses Organisation TopCrtanga Tapuhi Kaitiaki Aotearoa NZNO therefore calls on the government to implement mandatory folic acid fortification in New Zealand, joining the 81 countries who already do this. We hope our feedback is useful. We do not wish to make an oral submission. N?ku noa, na WM Di Cookson Research and Policy Assistant New Zealand Nurses Organisation PO Box 2128 I Wellington 6140 diana.cookson@nzno.orq.nz or 04 494 8244 About NZNO NZNO is the leading professional nursing association and uniori for nurses in Aotearoa New Zealand. NZNO represents over 51,000 nurses, midwives, students, kaimahi hauora and health workers on professional and employment related matters. NZNO is affiliated to the International Council of Nurses and the New Zealand Council of Trade Unions. NZNO promotes and advocates for professional exCellence in nursing by providing leadership, research and education to inspire and progress the profession of nursing. NZNO represents members on employment and industrial matters and negotiates collective employment agreements. NZNO embraces te Tiriti Waitangi and contributes to the improvement of the health status and outcomes of all peoples of Aotearoa New Zealand through influencing health, employment and social policy development enabling quality nursing care provision. vision is Freed to care, Proud to nurse. New Zealand Nurses Organisation Toputanga Tapuhi Kaitiaki Aotearoa References i Houghton, L. (2014). A country left behind: Folic acid fortification policy in New Zealand. New Zealand Medical Journal, 127(1399), 6-9. Hohmann-Marriot, BE. (2018). Unplanned pregnancies in New Zealand. Australian New Zealand Journal of Obstetrics and Gynaecology, 58(2), 247-50. i? Houghton, L. (2014). A country left behind: Folic acid fortification policy in New Zealand. New Zealand Medical Journal, 127(1 399), 6-9. Wald, Morris, J. Blakemore, C. (2018). Public health failure in the prevention of neural tube defects: Time to abandon the tolerable upper intake level of folate. Public Health Reviews, 39(2). Houghton, L. (2014). A country left behind: Folic acid fortification policy in New Zealand. New Zealand Medical Journal, 127(1399), 6-9. Vi Craig E, McDonald G, Adams J, et al on behalf of the New Zealand Child and Youth Epidemiology Service. Te Ohonga Ake. The Health of Maori Children and Young People with Chronic Conditions and Disabilities in New Zealand. Report prepared for the Ministry of Health. March 2012. Houghton, L. (2014). A country left behind: Folic acid fortification policy in New Zealand. New Zealand Medical Journal, 127(1399), 6-9. Vi? Gluckman, P. Beaglehole, R. (2018). The health bene?ts and risks of folic acid fortification of food. Office of the Prime Minister?s Chief Science Advisor (New Zealand) and Royal Society Te Aparangi. New Zealand Nurses Organisation TopUtanga Tapuhi Kaitiaki Aotearoa NEW ZEALAND COLLEGE OF I PUBLIC HEALTH MEDICINE November 12 2019 Submission to the Ministry for Primary Industries: Review of folic acid forti?cation of food The New Zealand College of Public Health Medicine would like to thank the Ministry for Primary Industries for the opportunity to make a submission on the Review of folic acid forti?cation of food.1 The New Zealand College of Public Health Medicine (the College) is the professional body representing the medical specialty of public health medicine in New Zealand. We have 222 . members, all of whom are medical doctors, including 185 fully quali?ed Public Health Medicine Specialists with the majority of the remainder being registrars training in the specialty of public health medicine. Public Health Medicine is the branch of medicine concerned with the assessment of population health and health care needs, the development of policy and strategy, health promotion, the control and prevention of disease, and the organisation of services. The Coliege partners to achieve health gain and equity for our population, eliminating inequities across socioeconomic and ethnic groups, and promoting environments in which everyone can be healthy. General points in New Zealand (NZ), women of child-bearing age are not consuming an adequate level of folic acid resulting in a signi?cant number of neural tube defect (NTD)-affected pregnancies, including spontaneous miscarriages and the need for medical terminations (both which should be included in the accounting of health losses and costs to New Zealand), and inequalities between Maori and non-Maori. Current approaches to improving folic acid intake, including supplementation for planned pregnancies and voluntary fortification by large bread makers are insuf?cient to address this health need. The introduction of mandatory foiic acid forti?cation in NZ has great potential to positively impact on the number of NTDs. The College supports MPl?s proposal to introduce mandatory fortification of all non-organic wheat flour for bread-ma king purposes (Option 3b in the MP1 discussion document),1 as a sensible, feasible, highly cost-effective, safe, and equitable approach to reducing NTDs in NZ. Thank you for the opportunity for the to submit on the Review of folic acid fortification of food. We hope our feedback is helpful and are happy to provide further clari?cation on matter covered in this submission. Sincerely, .. Dr Felicity Dumble, President, PO Box 10233. The Terrace. Wellington 6143 Level 7, Davis Langdon House, 49 Boulcott Street, Wellington 6011 1 +64 4 472 9183 Submission Form Introduction Folio acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is ovemhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email to: Food.Polic1@mgi.govt.nz While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Aarushee Kaul or contact person: Policy and Communications Coordinator Organisation (if applicable): New Zealand College of Public Health Medicine Email: Of?cial information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Official information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to sufficiently reduce the risk of NTD-affected pregnancies across the New Zealand population. .. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. . Cl Disagree. El Unsure. Please explain why; The College broadly agrees with the problem statement. NTDs, such as spina bi?da or anenoephaly, can lead to miscarriage, stillbirth and major disabilities. NZ experiences a signi?cant burden of using global burden of disease data} the College estimates that in NZ about 1064 disability-adjusted life years are lost yearly to NTDs. NTDS place an enormous emotional stress and a huge ?nancial burden on whanau and communities. In 2019, the average lifetime cost of an NTD?affected live~birth, compared with that of the general population, was estimated at $938,000, (which includes costs such as that of caregivers, health care educational support and lost productivity).3 The College is committed to a vision of a fair and just society that accords with to Tiriti Waitangi and where Maori and non-Maori have equitable health outcomes, and supports initiatives that will prioritise the needs of the most 5 NTDS affect Maori communities disproportionately. From 2000 to 2015, the rate of NTD-affected live births was 4.58? 0,000 live births among Maori women, compared with 281110300 live births among NZ European women} MTG-affected births place tremendous stress on the child?s iwi and hope. We note with concern that, although the information provided by includes data about this inequity, there is no reference to it in the problem statement. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE l3 Agree. El Disagree. Unsure. Please explain why: The College supports the review's objective to ?increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected increasing equity in health outcomes'. Forti?cation is a low-cost, wide-reaching public health intervention with the potential to reach even the most vulnerable populations when implemented reasonably. As acknowledged in the MPI discussion paper,1 fortifying a staple food can be an ef?cient and equitable way to ensure everyone bene?ts regardless of socioeconomic status, age, gender or (health) literacy. ?Consumer choice' vs. the rig? his of geogle and their familieshvhanau born wit_h_. or unable to be born because of NTDs The College is concerned that previous attempts to introduce folic acid forti?cation have not been successful, due in part to concerns about the limitations being placed on consumer choice. Whilst we recognise that consumer choice and industry impact are criteria that are important to some sections of society, we believe that these considerations should always be secondary to potential health and equity bene?ts. We believe that the signi?cant bene?ts to babies, mothers and society that can be gained through folate forti?cation, especially in addressing the disproportionate burden of NTDs amongst Maori, outweigh the advantages of consumer choice and industry convenience. For those who argue autonomy and wanting the right to eat baked goods not forti?ed with folic acid, we note that children born with NTDs, and the many more familiesnvhanau of children who don't survive to be born with NTDs, in a totals-depleted food and public policy environment, have little choice to even lose in the ?rst place. In terms of arguments pitched as the rights of many over the rights of a few (in Appendix 3 of the discussion paper1 the College considers these egregious. Many people and families are affected by NTDs. The College estimates that New Zealand has lost nearly 18,000 disability-adjusted life years from NTDs since 2009, which is appreciable. New Zealand already accepts the rights of fewer people very badly affected overriding the lesser impacts on many people's 'autonomy?, eg. the ?uoridation of community water supplies.3 or very recently with ?rearm control measures following the terror attacks in Modelling the costs and bene?ts The College has reservations about the Cost-Bene?t Analysis (08A) methodology used by Sapere Research Group.3 and considers the assumptions much too moserva?ve. As indicated in the discussion paper, the CBA measured only the bene?ts for NTD~affected live births and stillbirths, and not NTD-affected terminations (for what Sapere considered both excessive difficulties quantifying the ?nancial impact of terminations and ethical challenges)- We consider the CBA should have considered all NTD-affected live births and foetal deaths, including not only still births but also NTD-induced terminations.10 The discussion caliper1 (p.57) provides a relatively high rate for induced terminations for NTDs an average of 29 per year (between 2011 and 2015), which is signi?cant in addition to the yearly averages of 26 NTD?affected live births and 9 NTD- affected stillbirths. While the inclusion of induced terminations is potentially contentious. given the high number of average yearly terminations, we submit that NTD?associated terminations should at a minimum have been included in the sensitivity analysis. The termination number is high and provides even more incentive to prevent NTDs. Other factors mentioned in the Sapere report, but not measured in the CBA and which nevertheless should have been counted, are: . Wider impacts on family and whanau of caring etc. for children surviving with NTDs. These impacts are considerable. (Wider impacts are captured in frameworks such as Factors for Consideration and Treasury's Wellbeing Framework.) 0 Health impacts on parents and family from foetal deaths and from medical terminations forced by unsalvageable NTDs in pregnancy. - Possible reductions in the severity of remaining NTDs (aside from decreased incidence). - Decreasing rates of folate de?ciency in adults and children across the population, with associated health effects. Even more importantly, the Sapere CBA also excludes spontaneous miscarriages likely amenable to dietary folate. The above 64 annual MID-associated live birthistillbirthitennination counts are small when compared with possible spontaneous miscarriages likely amenable to dietary folate. We estimate that there are 15 to 21 times as many NTD-affected cases of spontaneous miscarriages each year as there are live births or foetal deaths (including induced terminations),i ?1 which is a signi?cant amount. Spontaneous miscarriages carry trauma for expecting mothers, parents and whanau, alongside extra costs to the health sector, and should have also been included in the CBA. Other factors not mentioned in the Sapere report, which should have been counted, are the other health bene?ts from better dietary folate intake catalogued in the 2018 joint report by the Office of the Prime Minister's Chief Science Advisor and the Royal Society of New Zealand Te Aparangi] where dietary folio acid reduces or potentially reduces the risks of: - birth defects such as orofacial (lip/palate) clefts, heart defects, urinary tract defects, Down - Adverse pregnancy and birth outcomes such as pre-eclampsia, placental detachment from the uterine wall, spontaneous abortion, pro-term delivery, and low birth Diseases of age eg. strokes, cardiovascular diseases, speci?c cancers, osteoporosis, and cognitive dysfunction.7r Given the exclusion of NTD-aflected spontaneous miscarriages and later medical terminations with wider impacts likely amenable to dietary folate, and other factors, the College considers the Sapere CBA considerably underestimates the population bene?ts, and undercounts the cost-effectiveness of the various folate forti?cation proposals. The College does however support Sapere use of the 3.5% discount rate? in the CBA. The College strongly supports an investment approach to health, which takes a long-term view and accounts for full long-term costs.? The considers that discounting of non-budgetary costs and bene?ts overtime should use a social rate of time preference with a long-term rate of return that is riskless (to. risk-free) rather than risk-adjusted, and which considers intergenerational impacts.M This means using a lower discount rate than was used and promoted years ago.15 As an example, cost-effectiveness analyses for pharmaceuticals and medical devices discount uses a i The College calculates that annually 970 to 1380 spontaneous miscarriages are excess when comparing total folate levels in pregnant women (calculated relative risk (RR) 1.08 for history of folate intake preconception for quintiles with folate <800 uglday vs. quintile with folate >800 uglday (OS) in the Nurses Health Study?ll (Gaskigs et al. Obstet Gynecol. 2014 Table 2, hence with 1.3% risk of spontaneous miscarriages due to folate de?ciency all pregnancies. applied to NZ vital statistics hence imputed pregnancy counts (calculated algebraically from: 58020 live births. 288 still births. 13282 terminations (HSQC da_ta 2019); 15-20% rates of spontaneous pregnancies?. Calculations available on request. riskless rate of return, set by PHARMAC in 2007 at 3.5% (based on the then 5-year average real risk- free long-term government bond rate). PHARMAC says that it does not incorporate risk into the discount rate for cost-effectiveness analyses, as discounting represents individuals time preferences and any risk (or future uncertainty) is taken into account elsewhere in modelling.? Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity. consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. l3 Unsure. Please exptain why and provide any evidence you may have: Under Optionls) 1 (and 2), compliance would be achieved through internal auditing by signatories to the Code of Practice and sampling of supermarket products by the Baking industry Research Trust. MPl?s monitoring of industry compliance would continue once every five years. The College notes that, despite a 50% target, after six years of working to the voluntary code, in 2017, the volume of bread being forti?ed increased to only 38%, from a starting point of 14%. Furthermore, only 54% of forti?ed bread tested in 2017 was within the range of 150 to 250 micrograms per 100 grams. This signals that when forti?cation is left to the industry it is unlikely to be implemented to target and the Coliege is doubtful of the bread industry's level of commitment and compliance. As a principle, the College is generally opposed to strategies that involve partnership with industry to implement. Historically, industry groups have attempted to be ?potential collaborators? in order to reduce harm. despite obvious vested interests.? The pro?t goals of commercial companies are in conflict with their desired role as partners in efforts to reduce harm and makes their involvement in public health interventions ?ethically questionable? with potential to delay government Examples of such industries include alcohol, big tobacco and big oil.? ?3 Therefore, we agree with the assessment that continuing the status quo would do little to reduce rates of NTD?atfected pregnancies, and that this approach would not help achieve health equity. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY IE Agree. El Disagree. Unsure. Piease explain why and provide any evidence you may have: We agree with the assessment of option 2 and note that while this approach has the potential to prevent a number of future NTDs and result in substantial taxpayer savings, the approach relies completely on the voluntary participation of large plant bakers- It is therefore unlikely to achieve the objective set by this review. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products. and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of foiic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment of Option 3a and note that this option would have signi?cant positive health impacts and would be more effective than a voluntary forti?cation approach. We also note that this approach does not pose a public health risk to non-target groups such as children. However, we note that the compliance and monitoring costs in operationalising this approach would be high due to the high number of bakeries that would be affected and foresee that this option would be dif?cult to monitor and may not be the most cost-effective approach. Therefore, we do not support this op?on to achieve the review?s objective. Option 31): Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be forti?ed with folio acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 - 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: The College agrees that Option 31: would have better health bene?ts than Options 1, 2 and So, although it will not prevent as many NTDs as Option 3o. We note that a small percentage of children may exceed the upper limit for folio acid intake at this level, but at a popuiation ievel this proportion is considered acceptable. We note that Option 3b provides the greatest value for money compared with Options 1, 2 and 3a. Compliance and monitoring costs will not be as signi?cant as Option 3a due to the number of mills affected being small. Like Options 3a and 3c, Option 3b will work to achieve health equity in NTD outcomes behveen Maori and non-Maori. This is because mandatory forti?cation removes the eiement of chance inherent in a voluntary approach and is not reliant on the health literacy of consumers. Option also provides a high level of consumer certainty that all non-organic wheat bread is forti?ed. Additionally, Option 3b is likely to result in greater certainty of consistently achieving the target folic acid range, given the small number of mills, compared with the iarge number of bakeries (as per Option 3a). Finally, it is likely that of all the mandatory options, Option 3b offers the greatest choice, as consumers can still choose between organic or non-wheat breads. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option 30 would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: We agree with the assessment of Option 3o. Option expands on the range of food products that would contain forti?ed flour over option and we note that there may be some potential safety risks associated with this. The Institute of Medicine set the Tolerable Upper Intake Level for folic acid (from supplementation and forti?cation) at looting (1 mg) per day. for adults} The consequences of exceeding the upper limit for children are unknown as the Upper limit was only set for adults, and then adjusted for body weigi?rt.T As the level of forti?cation increases, the likelihood of people exceeding the upper limit also increases} The College is wary that forti?cation of all non-organic wheat ?our (as per Option 3c) may result in a proportion of children exceeding this upper limit. We note MPl's modelling estimate that year olds would consume too much folic acid under this approach, and for this reason cannot provide unquali?ed support for Option Sc. Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. El Disagree. Cl Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? The College does not support the implementation of the voluntary approaches (Options 1 and 2) for the reasons provided above. The College is supportive of the implementation of the mandatory approaches (options Ba, 3b and 3c). We agree with the proposed plan for monitoring folio acid levels and health impacts of fortification (in conjunction with the Ministry of Health) as well as the plan for dealing with non- compliance. General comments If you have any other general comments or suggestions for the Folic acid forti?cation: increasing folic acid availability in food discussion paper, please let us know. The College does not consider the voluntary approaches (Options 1 and 2) would achieve the review?s objective or have meaningful nor suf?cient population health and health equity impacts. For the reasons provided above the College supports Option 3b as the best approach to achieve the review?s objective, reduce sufficiently the number of NTDs in NZ and wont to safely achieve health equity in NTD outcomes between Maori and mn-Maori. References 1. Ministry for Primary Industries. Folic acid fortification: increasing folic acid availability in food. New Zealand Food Safety Discussion Paper no: 2019/08 Wellington: MP1, 2019. food-discussion- document] 2. Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2017 [(330 2017) Results. Seattle: Institute for Health Metrics and Evaluation (IHME), University of Washington, 2018. hdx.healthd a -results?tool) code 812.1.1 neural tube defects New Zealand, calculated 1063.9 annual mean DALYs 2013-2017; 17935.5 DALYS 2009-2017 3. Moore D, ?I'oung (Sapere Research Group). Folic acid fortification: both society and individuals benefit. New Zealand Food Safety Technical Paper No: 2019/05. Wellington: MPI, 2019. 4. New Zealand College of Public Health Medicine. maori Health Policy Statement. Wellington: 2015 5. New Zealand College of Public Health Medicine New Zealand Medical Association. Policy Statement on Health Equity (adopting the New Zealand Medical Association Position Statement on Health Equity 2011). Wellington: 2016. (htt s: hm.or .nz media 58923 2016 11 17 hm health a ui li statement. df 10 6. New Zealand College of Public Health Medicine. Policy Statement on Choosing Wisely. Wellington: 2018. wisely 7. Office of the Prime Minister?s Chief Science Advisor, Royal Society of New Zealand Te Aparangi. The health benefits and risks of folic acid fortification of food. Wellington: OPMCSA, 2018. foodgdf} 8. New Zealand College of Public Health Medicine. Policy Statement on Water Fluoridation. Wellington: 2013. 06 05 water fluoridation policy 4? 9. Public Health Association of New Zealand, New Zealand College of Public Health Medicine. Joint submission on Arms (Prohibited Firearms, Magazines, and Parts) Amendment Bill. Wellington: PHANZ, 2019. submission - arms amendment 10. Perinatal and Maternal Mortality Review Committee. Twelfth Annual Report of the Perinatal and Maternal Mortality Review Committee: Reporting mortality 2016. Wellington: Health Quality 8: Safety Commission, 2018. 11. Gaskins AJ, Rich-Edwards JW, Hauser R, et al. Maternal prepregnancy folate intake and risk of spontaneous abortion and stillbirth. Obstet Gynecol. 12. Wang Y, Zhao N, Qiu J, et al. Folic acid supplementation and dietary folate intake, and risk of preeclampsia. EurJ Clin Nutr. 13. Fekete K, Berti C, Trovato M, et al. Effect of folate intake on health outcomes in pregnancy: a systematic review and meta-analysis on birth weight, placental weight and length of gestation. NutrJ. 2012;11:75. 14. New Zealand College of Public Health Medicine. Public Health as an Investment Policy Statement. Wellington: 2019. 10 oh as an investment policy 15. Metcalfe S, Gunasekara S, Baddock K, Clarke L. Time for healthy investment. Wellington: New Zealand Medical Association, 2017. 2017 7390) 16. Tinawai G, Gray T, Knight T, Glass C, Domanski N, et al. Highly deficient alcohol health warning labels in a high?income country with a voluntary system. Drug Alcohol Rev. 17. Diethelm P, McKee M. Denialism: What is it and how should scientists respond? EurJ Public Health. 13. Daube M. Tobacco targets doomed to fail? 2 Med J. apri 201817538) 11 New Zealand Medical Association Te Hauora m5 nga 1w: Katoa 12 November 2019 Rebecca Doonan Adviser, Food Science Ministry for Primary Industries PO Box 2526 Wellington 6104 By email: Food.Policv@mpi.govt.nz Folic Acid Forti?cation Dear Rebecca Thank you for inviting the New Zealand Medical Association (NZMA) to provide feedback on the above consultation. The NZMA is New Zealand?s largest medical organisation, with more than 5,000 members from all areas of medicine. The NZMA aims to provide leadership of the medical profession, and to promote professional unity and values, and the health of all New Zealanders. We recognise the principles of te Tiriti Waitangi and the special obligations to Maori, particularly to ensure equity and active protection. Current disparities in health outcomes between Maori and non?Maori are unacceptable. The NZMA is committed to advocating for policies in health and the social and wider determinants of health that urgently address these disparities and contribute to equity of health outcomes. Our submission has been informed by feedback from our Board and Advisory Councils. The NZMA welcomes review of the current voluntary approach to folic acid forti?cation. We have previously advocated strongly for mandatory folic acid forti?cation.1 We reiterate our support for mandatory folic acid forti?cation, a position which is consistent with the advice in a 2018 report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi.2 There is categorical evidence that folic acid forti?cation reduces the prevalence of neural tube defect (NTD)-affected pregnancies, while there is no consistent evidence that folic acid forti?cation of food has any harmful health effects. We note that the report by the Chief Science Advisor and the Royal Society concluded: ?with respect to NT reduction, the bene?ts to parents, child, family/whdnau and society as a whole of introducing mandatory forti?cation of packaged bread outweighs any potential adverse e??ects?. NZMA. The future of folic acid forti?cation. Submission to MPI. 9 July 2012. Available at data/assets/pdf ?le/0014/ 1625/3111) folicacidpdf 2 Of?ce of the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. The Health Bene?ts and Risks of Folic Acid Forti?cation of Food. June 2018. Available at nz/wp- Doctors leading in health 26 The Terrace, PO Box 156, Wellington 6140 Tel: (04) 472 4741 Fax: (041471 0838 Email: nzma@nzma.org.nz The rate ofNTD-affected pregnancies in New Zealand (10.6 per 10,000 total births) is higher than comparable countries where mandatory forti?cation has been introduced, such as Australia (8.7 per 10,000 total births), Canada (8.6 per 10,000 total births) and the US (7 per 10,000 total births). Of particular interest is that in Australia, NTD rates fell by 14% post mandatory forti?cation in 2009 from 10.2 per 10,000 births to 8.7 per 10,000 births.3 We agree that the current voluntary approach to forti?cation in New Zealand is not increasing folate status adequately for the optimal reduction of NTDs. We note that in 2017, the volume of forti?ed packaged sliced bread was 38% and the average folic acid level of forti?ed bread sampled was 166 per 100g of bread, less than the target level of 200 per 100g of bread.4 Accordingly, we are opposed to options 1 and 2 in the consultation document and believe that New Zealand must implement mandatory folic acid forti?cation. Of the three options for mandatory forti?cation that are proposed, our preference is for option 3b (mandatory forti?cation of non-organic wheat ?our used for making bread). We note that this would require bread-making wheat ?our to be forti?ed at the ?our mill as the wheat is milled, and understand that this is the approach that has been taken in Australia. We note that the health impact of this option is estimated at preventing 162 to 240 extra NTDs over 3 0 years while there would be a net savings of $32.2 to $54.6 million over 30 years. While this option would limit the choices to consumers wanting unforti ?ed bread products to non-wheat and organic bread, our View is that this limitation is fully justi?ed given the overwhelming population health bene?ts associated with reducing NTDs (and all its impacts). These include bene?ts to children, parents, families whanau, and wider society, as well as considerable economic bene?ts. We are concerned that the cost-bene?t analysis (CBA) by Sapere5 referred to in the MP1 discussion document underestimates the population bene?ts of forti?cation by counting just NTD?affected live births and fetal deaths {which by de?nition is fetal deaths at 20+ weeks gestation). As such, the cost-effectiveness estimates for forti?cation are too low conservative. Notably, the CBA excludes induced terminations associated with NTD-affected pregnancies. supporting document gives a relatively high rate for induced terminations (29 per annum, on average, ??om 2011-2015, compared with 26 NTD-affected live births and 9 stillbirths per annum during the same period).6 We contend that induced terminations associated with NTD- affected pregnancies should at least be considered in sensitivity analysis. The CBA also does not consider spontaneous miscarriages that are likely to be due to inadequate dietary folate. A member of our Specialist Advisory Council with expertise in epidemiology has used the Nurses Health Study 117 to calculate that there are about 800 to 1,100 such spontaneous miscarriages each year in New Zealand.8 This suggests there are 13 to 18 times as many cases of spontaneous 3 New Zealand Food Safety. Folic acid forti?cation: technical supporting document. Technical Paper No: 2019104.0ctober 2019. Available at lechnical-supporting-document 4 MP1. Voluntary Folic Acid Forti?cation. Monitoring and Evaluation Report. Technical Paper No: 2018/02. February 2018. Available at 5 Moore Young M. Folic acid forti?cation: both society and individuals bene?t. Sapere. October 2019. Available at individuals-bene?t 6 Gibbs M, et a1. Folic acid forti?cation: technical supporting document. NZ Food Safety Technical Paper Np: 2019/04. October 2019. Available at technical-supporting-document 7 Gaskins AJ, et a1. Maternal prepregnancy folate intake and risk of spontaneous abortion and stillbirth. Obstet Gynecol. 2014 Available at nihgov/pmc/ar?cles/PMC4086728/ 8 Details of methodology and calculations can be supplied on request miscarriages each year due to inadequate dietary folate as there are NTD?affected live births or fetal deaths, a serious new item to factor when considering the cost-effectiveness of forti?cation. Of particular importance is the assessment that mandatory folic acid forti?cation would help reduce the inequities in NTD rates, particularly for women with less education, younger mothers and Maori women. Maori women have signi?cantly more live NTD births than non-Maori women and would therefore bene?t more from a mandatory approach. Finally, we ask MP1 to ensure that due weighting is given to organisational submissions in the analysis of responses to this consultation. We hope our feedback is helpful and look forward to learning the outcome of this consultation. Yours sincerely km Dr Kate Baddock NZMA Chair Final 11*? November 2019 . New Zealanders for . . HEALTH RESEARCH . Ng? ?l??ngata a Aatearoa n16 te Rangahau Hauora ?New Zealand?s peak body representing the entire health and medical research pipeline? Submission on Folic acid fortification: Increasing folic acid availability in food New Zealand Food Safety Discussion Paper No: 2019/08 Introduction New Zealanders for Health Research (NZHR) was established in November 2015 to bring about increased investment in health research from government, industry and philanthropy. We have a commitment to ensuring that the results of health research are translated into policy and practice. As part of our aim to bring about a society which is well informed about health and medical research in New Zealand we?ve specifically asked New Zealanders about their beliefs about the safety and effectiveness of fortifying flour with folic acid to prevent neural tube defects, and believe that our findings are relevant to the MPI consultation process. submission is that fortification of flour with folic acid should be supported because: 0 It is unequivocally supported by the results of health research which has been undertaken both internationally and in New Zealand . It will have a significant impact on the incidence and prevalence of neural tube defects, including spina bifida, resulting in improved population health outcomes; a lowering of the burden of disease on society, families and individuals; and reduced health care costs . It will be challenging to rely on people voluntarily opting to proactively and consistently include folic acid in their diets at appropriate and effective doses Research on the benefits and risks of consuming folic acid We refer to the June 2018 peer reviewed report produced by the Prime Minister?s Chief Science Advisor (PMCSA) and the Royal Society Te Aparangi1. The report concludes that there is compelling evidence that mandatory folic acid fortification is associated with lower rates of neural tube defects, and that taking folic acid supplements at the recommended doses in pregnancy has no adverse effects on pregnancy outcome or the child?s health. No evidence was found to link folic acid supplements to increased risks of neurological! cognitive decline, diabetes, or cardiovascular disease; nor was there evidence that unmetabolised folic acid that remains within the body?s circulation is harmful. Based on an overall assessment of the evidence, and also considering the need to ensure that disadvantaged people including Maori receive benefit, the report concluded that the benefits of mandatory fortification of packaged bread with folic acid outweigh any potential adverse effects. 1 The Health Benefits and Risks of Folic Acid Fortification of Food.A report by the Office of the Prime Minister?s Chief Science Advisor and the Royal Society Te Ap?rangi June 2018. foodpdf llPage Final 11th November 2019 . New Zealanders for HEALTH RESEARCH . Ngi ?ngata Aotearoa m6 te Rangahau Hawra Impact on the incidence and prevalence of neural tube defects Rare Disorders New Zealand estimates2 that the incidence of neural tube defects in live births which could be prevented by consuming folic acid is about 24 cases per year, half of which are associated with a diagnosis of spina bifida, and half with anencephaly (which becomes fatal soon after birth). This means that there are about twelve New Zealanders per year who are unnecessarily destined for a lifetime of disability (with annual childhood rehabilitation costs of about $400,000 per year, and a significant burden of care which is borne by their families), and a further 12 who are denied the right to life altogether. These figures are consistent with the more detailed analysis presented in the PMCSA report. Voluntary consumption of folic acid According to the results of 2019 opinion poll3 54% of respondents agreed that adding folic acid to flour and bread is a safe and effective way of preventing spina bifida and neural tube defects, 13% disagreed, and 33% didn?t know. Furthermore, 47% of females aged between 18 and 34, a significant component of the folic acid target population, responded ?don?t know? to this question. These figures suggest that it would be challenging to convince women to voluntarily take folic acid supplements in numbers sufficient to have a significant impact on the incidence of neural tube defects. Such supplements have already been actively marketed in New Zealand for several years with, as would appear from the NZHR poll results, only limited success. We also note that the 13% who disagreed about the safety and effectiveness of adding folic acid to bread and flour is significantly lower than the 18% who said they disagreed with a similar statement about adding fluoride to public water supplies. We believe therefore that any public opposition to fortifying flour with folic acid would be manageable and not of sufficient magnitude to warrant not going ahead. Conclusion NZHR supports proposals to fortify flour with folic acid, and favour either of the report?s4 options (3B) mandatory fortification of non-organic bread-making wheat flour, or (3C) mandatory fortification of all non-organic wheat flour. In developing this submission we have consulted with our partners and members as set out below {and from whom we derive 100% of our funding). 12lth November 2019 Chris Higgins Chief Executive New Zealanders for Health Research 5 ceo@nz4healthresearch.org.nz 2 s: .nz about-us news folic-acid-fortification 3 New Zealand Speaks! 2019 Roy Morgan NZHR Opinion Poll. August 2019. 4 MPI. Folic acid fortification: Increasing folic acid availability in food New Zealand Food Safety Discussion Paper No: 2019/08. October 2019. ZIPage Final 11th November 2019 New Zealanders for . . HEALTH RESEARCH . N95 Tailgate Aotearoa mo :9 Rangahau Hauora NZHR partners and members Platinum Gold Silver Bronze Chrome Foundation . OTAGO NIW ZIAIAND umvtasnv All]? Tr 9 MALAGHAN mt?l?qw MSD obbvie t?x New Zealand 4 Assncimion of Clinical Base C1 . ?r BUM 5: cure kids (bf ROY VI MORGAN . douqlas I a, MASSEY UNIVERSITY 6 TE KUNENGA PUREHUROA UNIV EHSETY OF NEW ZEALAND CAWTHRON Mmolm' 3-week- i 9:952:11: 1?91:th 3 3 ?age Submission Form introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread. or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email t0: WW While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:08pm on 12 November 2919. Submitter details: Name of submitter Dr Tim Jellyman, PreSIdent. PSNZ or contact person: Secretariat: Denise Tringham 0 Box 2005, Raumali Beech, Paraparaumu 5032 Tel: (04) 902 4827 Fax: Organisation (if applicable): Paediatric Society Of NZ Email: denise@paediatrics.org.nz Official lnfonnation Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily fortified with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. Disagree. Unsure. Please explain why: The Paediatric Society of New Zealand is a multidisciplinary organisation with a membership of many hundreds of child health professionals across NZ. The aims and objectives of the Society are to stimulate interest in and to promote the scienti?c study of chiid health and Paediatrics in New Zealand, and to engage in all activities which, in the opinion of the Society, may be necessary from time to time in the interests of child health, and to engage in the following activities which promote the welfare of New Zealand children. The Paediatric Society of New Zealand has consistently advocated for mandatory forti?cation of ?our/bread in New Zealand. PSNZ has contributed positively through previous submission processes, and has worked cooperatively with the Ministry of Primary industries and it predecessors in providing data, information and sopport to inform government policy on this issue, including constructive participation on the Folic Acid Working Group by its representative, Dr Andrew Marshall. PSNZ believes mandatory fortification will be effective in reducing NTD pregnancy rates down from an estimated 12-14 per 10000 (76?90 per year in NZ) to the international ??oor?level" seen in countries with mandatory forti?cation, such as USA and Canada, of 7-9l10000 (40-50). This would prevent approximately 30 Neural Tube Defect pregnancies per year. PSNZ agrees with the evidence summarised by MPI which suggests the current policy in New Zealand is not increasing folate status adequately for the optimal reduction of NTDs, and the strong advice to introduce mandatory forti?cation in a 2018 report by the Prime Minister?s Chief Science Advisor and the Royai Society Te Aparangi. These papers highlighted the weight of international evidence which has been present for a number of years that the greatest reduction in NDTs can only be achieved through mandatory forti?cation. This evidence for the benefits of mandatory forti?cation were clear in 2012 when PSNZ made a submission to in support of mandatory forti?cation. We agree that more than half of all pregnancies in New Zealand are unplanned. Unplanned pregnancies occur more frequently in the more disadvantaged sectors of the community, especially younger women including teenagers, and women in low socioeconomic groups. These women are more likely to have a diet low in naturaliy folate rich foods and less likely to be taking folic acid supplements. Therefore a public health approach is necessary to reach these women. Maori are disproportionately represented in many adverse health outcomes that re?ect social disadvantage, and we agree with your focus in reducing ethnic disparities in health outcomes. We concur that mandatory forti?cation is likely to reduce disparity in NTD rates, as has occurred in Australia following mandatory forti?cation. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. El Unsure. Please explain why: This review is very important given the lack of progress in preventing NTDs since the voluntary regime was put in piece in 2012. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large breed bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: PSNZ does NOT support the status quo. PSNZ agrees with your assessment that such an approach continues to lead to inadequate levels of prevention of NTDs, and fails to address heatth inequities through social disparities. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: PSNZ does NOT support this option. Industry has struggled to reach the target of 50% is in a voluntary regime is highly unlikely to be able to reach 80% under a further voluntary regime. The time taken to slowly increase percentage of breads forti?ed over a number of years equates to each year more babies being born with NTD that were preventable. Option 3a: Mandatory forti?cation of non-organic bread Option 33 would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folio acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORHFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: PSNZ does NOT support this option. Although overall PSNZ supports mandatory forti?cation, options 3b and 3c provide a much more effective means of forti?cation. As noted in your report the ability of a very large number of small bakeries to implement this change is challenging, there would be high compliance costs in monitoring and a high likelihood of great variability in the amount of folic acid in fortified breads, with a high likelihood many would not actually be fortified effectively. Because of this variability the health gains are likely to be significantly less than for options 3b and 3c. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat ?our for bread-making would be forti?ed with folic acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FDLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: PSNZ supports this option. it aligns NZ with Australia where substantial health bene?ts have been documented since mandatory forti?cation was introduced. It is much easier to implement and monitor compared to option Be. It is tikely to provide substantial reduction in NTD rates which witl bring NZ close to the optimal prevention rate. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas- The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: PSNZ also supports option 3c. We acknowledge the concern regarding excess folic acid consumption in children with this option. However we would point out that the recommended Upper Limit for Folic Acid is not based on evidence of actual harm from overdose, but is rather a construct based on normal ranges. Therefore we consider the risk of a proportion of children exceeding the UL for folic acid to be a theoretical harm only rather than an actual danger. Option So would yield the highest possible level of population prevention of NTDs. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE THE APPROACH TO l2] Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. 10 PSNZ has consistently advocated for mandatory forti?cation of bread or flour for the prevention of NTDs. The efficacy of Fire-conceptual folic acid in preventing Neural Tube Defect has been established since the 1980s, and the ef?cacy of a public health approach, namely the mandatory fortification of flour to reach the whoie population has been proven consistently in international meta-analyses demonstrating a reduction in NTD prevalence following mandatory forti?cation since 2010. The bene?ts of preventing NTD pregnancies through mandatory folic acid forti?cation inciude reducing the burden of living with spina bifida to the individual and their family. individuals with Spina Bifida experience ongoing pain, disrupted home and school iife from frequent infections and hospitalisations, physical limitation, lost opportunities, and stress on their families and themselves. Other bene?ts include reducing the grief of perinatal loss of a baby with anencephaly, and reducing the numbers of women who face the agonising decision to terminate a NTD pregnancy. Financial bene?ts of reducing NTD rates include reducing hospitai costs of Spine bifida patients, the lost family income, the community, special education and sector costs for each individual with a neural tube defect (NTD) who survives to adulthood. By comparison, the costs of mandatory forti?cation of flour are minimal. Mandatory forti?cation of bread with folic acid is safe. It is distressing to consider the impact on very many individuals and families of preventable ??35 since 2007, when NZ withdrew from the trans-Tasman agreement to fortify with folic acid. This report makes a strong case for mandatory fortification of ?our, and PSNZ strongly supports this conclusion and urges resolute action. 11 Ur HEALTH cmAuTv SAFETY . COMMISSION NEW ZEALAND It'upu Taurangf Herrera ism-amt] Perinatal and PO Bax 25496 Maternal Mortality Wellington 6146 Phi Committee New Zealand I T: +64 4 901 6040 . . 3 F: +64 4 90} 6079 1 1 November 2019 E: into@hqsc.govt.nz W: Ministry for Primary Industries Email: food.policy@mpi.govt.nz Kia ora, Folic acid fortification submission support for option 3b. Thank you for the opportunity to comment on the review of folic acid forti?cation of food. On behalf of the Perinatal and Maternal Mortality Review Committee I would like to support proposed option 3b: Introduce mandatory forti?cation of non-organic wheat flour used for making bread specialist bread-making flour would be fortified by the ?our millers at the mill. The is a national committee which sits within the Health Quality Safety Commission (the Commission) and is charged with reviewing and reporting on perinatal and maternal deaths in New Zealand with a view to reducing deaths and serious morbidity. There have been an average of 650 perinatal related deaths 1in New Zealand per year over the last 10 years. The 13th Annual Report2 shows that for babies of gestations 28 weeks and over, congenital abnormalities including Neural Tube Defects (NTDs), were the leading cause of death, accounting for around 40 deaths per year. The has a strong commitment to promote systems change to reduce preventable death. Our shared vision is: Te mahi tahi puta noa i te p?naha kia kore rawa ai mate, whara nga mama me a ratau pepi, whanau hoki mai i nga mate, wharanga ranei ka taea te arai. Working together across the system towards zero preventable deaths or harm for all mothers and babies, families and whanau. work towards this vision by providing evidence based recommendations to the sector. In September, we made the following recommendation to the Ministry for Primary Industries: .0 1 A perinatal related death is a fetal death (including termination of pregnancy and stillbirth) or neonatal death (up to midnight of the 27th day of life) at 20 weeks? gestation or beyond, and weighing at least 4009 if gestation was unknown. 2 3th lNAL.gdf We strongly recommend to the Government/Ministry for Primary Industries that folic acid forti?cation of bread be mandatory to reduce both mortality and serious morbidity from neural tube defects. Evidence There is strong and convincing evidence that mandatory forti?cation of food with folic acid 4 unequivocally reduces the prevalence of neural tube defects, and the bene?ts of this outweigh any potential adverse effects Justi?cation a) Congenital abnormalities, particularly neural tube defects, are a signi?cant contributor to terminations of pregnancy. b) There is signi?cant lifelong morbidity and mortality risk to babies from neural tube defects. The 2010 Eating for Healthy Pregnant Women/Nga Kai Totika min to Wahine Hap?3 produced by the Ministry of Health (the Ministry) recommended that women at low risk of a NTD affected pregnancy who plan to become pregnant, are recommended to take 800p of folic acid daily for at least four weeks prior to conception and for 12 weeks after conceiving to reduce the risk of NTDs. This is due to the fact that NTDs occur within the ?rst month of conception. Around half of all pregnancies in New Zealand are unplanned, and of those pregnancies that are planned, many do not see a health professional within the first month of pregnancy, meaning they miss this key assessments and screening. A regional study by Counties Manukau Health" found that women with limited resources, with no tertiary education, or not living with a husbandipartner are at a greater disadvantage when it comes to timely booking for antenatal care. it also found that late booking with a Lead Maternity Carer (LMC) was six times higher for women of Maori and Pacific ethnicity compared with those of European and other ethnicities in the Counties Manukau area. lnequities compounded by the lack of timely, culturally safe and properly resourced health and social services in poor communities. The Ministry reports annual rates of registration with an LMC in the first trimester of pregnancy. This also shows that first trimester registration rates of Maori mothers nationwide continues to be below the level of non-Maori mothers as shown below in figure 1. 3 4 Figure 1: Percentage of women registered with a lead maternity carer in the first trimester of pregnancy Aotearoa New Zealand, 2009?nun .N- Every year the Commission publishes A window on the quality of Aotearoa New Zealand?s health care. This provides a snapshot of the quality of health care in the country. This document comments on the above figure released by the Ministry, stating ?This inequity shows that almost half of pregnant Maori women are not receiving LMC care as early as possible and, as a consequence, may not receive optimum care and guidance." is very clear that it is not women and their whanau who are ?the problem?, but rather an under-resourced, overly complex and inadequately responsive maternity system. We are committed to honouring Te Tiriti Waitangi, which requires us to address socioeconomic, ethnic and geographical inequities in maternity for Maori through equitable systems-change approaches that raise the quality, timeliness, options and availability of care to improve health outcomes. Mandatory fortification is an equitable approach, as the benefits of folic acid are available across the population and does not depend on locality, ethnicity, socio?economic status, knowledge or motivations of services or whanau. In 2012 an audit report was prepared on congenital abnormalities using data for the calendar year of 20105. This showed that 211 of the 704 deaths in 2010 were due to congenital abnormalities, and 21 of these babies were diagnosed with NTDs (congenital abnormalities amenable to folate use). There will also be terminations of pregnancy associated with congenital abnormalities that are not able to be collected in data. Figure 2 below from the 2012 audit shows the gestation at booking versus gestation at first health care provider contact for babies who died in 2010. Most women have first contact with a health care provider outside of the first month, which is the window of opportunity when the neural tube is developing and closing. 5 Figure 2: Scatterplot of gestation at booking vs gestation first health care contact Only 7% of women included this audit reported taking folate before conceiving. Of the 21 women whose babies died from NTDs, 13 were recorded as taking folate at some point in pregnancy and only one was taking pre-conceptual folic acid as recommended by the Ministry of Health. Consumer choice is important in this discussion, but many people in New Zealand often do not realise they have a choice. A 2012 study by Mallard and HoughtonE of consumer behaviour among pregnant women in New Zealand, showed only half of all women surveyed knew some bread contained added folic acid, and among these women, less than 2% consistently chose voluntarily fortified bread during the period around conception by inspecting labels. Also 36% of these women surveyed, did not know that folic acid sUpp'lements reduces the risk of birth defects. The vast majority did not consider folate or folic acid content when choosing food to buy or to avoid. - Mallard and Houghton found that risks associated with mandatory fortification of bread was one of the reasons that women surveyed were against fortification of bread. As you note in the short guide for the consultation document, there is no consistent evidence that folic acid when fortified in food at the recommended level, has any harmful heath effects. However, mandatory fortification of food with folic acid unequivocally reduces the prevalence of neural tube defects, and the bene?ts of this outweigh any potential adverse effects. I would like to reiterate support for proposed option 3b, to introduce mandatory fortification of non-organic wheat flour used for making bread, so specialist bread-making flour would be fortified by the ?our millers at the mill. Nga mihi nui. John Tait Chair, Perinatal and Maternal Mortality Review Committee ?5 November 2019 A KAU A l. Submission on the review of folic acid fortification of food To the Ministry of Primary Industries Introduction This submission is from: The Population Health Directorate, Counties Manukau Health, Private Bag 93311, Ootaahuhu,1 Auckland 1640 - The following submission is on behalf of the Population Health Dir?ctorate at Counties Manukau Health (CM Health, Counties Manukau District Health Board). It cannot be taken to formally represent the views of CM Health and other parties from CM Health. This submission was informed by the views ofthe Population Health team. The Population Health Directorate?s role is to provide population health advice and analytical support to the DHB and to contribute to strategic planning, priority setting, and support for population health initiatives for the CM population. Surnmag This submission provides feedback'for MPI on the options for strengthening fortification of bread or fortifying wheat flour. Neural Tube Defects (NTDs) have wide ranging impacts on women, babies, whaanau and society with a disproportionate impact on Maaori. They can be prevented by increasing the intake of folic acid in women of reproductive age. However, folic acid supplementation and voluntary folic acid fortification in New Zealand have not achieved an acceptable reduction in NTD prevalence. The NTD rates in New Zealand are higher than other comparable countries where mandatory fortification has been introduced. We strongly recommend mandatory folic acid fortification as part of a comprehensive population health approach to reduce the prevalence and severity of NTDs. Context Counties Manukau District Health Board (DH B) is one of twenty district health boards established under the New Zealand Health and Disability Act 2000 Act 2000) to plan and fund the provision of personal health, public health and disability support services for the improvement of the health of the population. DHBs have responsibilities under the Act 2000 to improve, promote, and protect the health of our 1 Double vowels are used rather than macrons in this document as is the convention for CM Health, in recognition of this convention for Waikato-Tainui as Mana Whenua in our rohe -1- people and communities, improve health outcomes for Maaori and reduce, with a view to eliminating, health outcomes disparities. Counties Manukau DHB recognises and respects Te Tiriti Waitangi as the founding document of New Zealand and aims to fulfil its obligations as agent of the Crown. The relationship with the taangata whenua of the rohe is expressed through a board-to-board relationship with Mana Whenua i Taamaki Makaurau. The articles of Te Tiriti implicitly recognise the important role the health sector plays in recognising the indigenous rights of Maaori and therefore the status and rights of Maaori to achieve equitable health outcomes in comparison to the rest of the population. The Counties Manukau DHB serves an estimated 569,400 people in 2019 who reside in the local authorities of Auckland, Waikato and Hauraki District.2 Counties Manukau (CM) is one of the fastest growing district health board populations in New Zealand with a youthful and ageing population. CM is home to New Zealand?s second largest Maaori population (91,000; 11% of all Maaori living in New Zealand; 16% of the CM population). Across CM, the circumstances and health of people are not equal. Thirty?six percent of the CM population overall, and nearly half of children in CM, live in areas of high socioeconomic deprivation deciles 9 and 10).3 The Maaori community is relatively socioeconomically deprived compared with our more advantaged populations, with 58% of Maaori in CM living in areas classified as deciles 9 and 10 at the time of the 2013 Census. General comments Neural tube defects (NTDs) such as spina bifida are an important and preventable public health problem with a range of health, financial, social and emotional impacts. The NTD rate in New Zealand is 10.6 per 10,000 total births which is higher than other comparable countries where mandatory fortification has been introduced.?% There are inequities for Maaori who have a higher rate of NTD live births than other population groups.5 We have reviewed the various policy options for increasing the folic acid intake of women of reproductive age to outline the clear rationale for a mandatory fortification approach in New Zealand. 1. Targeted approaches with supplementation are insufficient Natural food sources do not provide enough folate to prevent NTDs and there is unequivocal evidence that maternal folic acid supplementation early in pregnancy protects against However, NTDs occur during the early weeks of pregnancy, often before women are aware they are pregnant. Therefore, targeted approaches with folic acid supplementation only work for women who have planned their 2 Population data is sourced from the District Health Board Ethnic Group population projections (2013-Census Base) 2018 update. 3 New Zealand Index of Deprivation is an area-based measure of socioeconomic deprivation. It measures the level of deprivation for people in each small area. It is based on nine Census variables. is often displayed as deciles or quintiles. Quintile 5, or deciles 9 and 10, represents people living in the most deprived 20 percent of these areas. 4 MPI. Folic acid Fortification: Increasing folic acid availability in food. New Zealand Food Safety Discussion Paper No: 2019/08. 5 Voluntary Folic Acid Fortification: Monitoring and Evaluation Report. technical paper no: 2018/02. 6 The Health Benefits and Risks of Folic Acid Fortification of Food: A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. June 2018. pregnancy and are aware of the importance of folic acid for pregnancy. Only 8.7% of all women who had a live or stillbirth in 2015 were dispensed folic acid tablets before pregnancy,7 partially attributable to over 50% of pregnancies in New Zealand being unplanned.?3 Self?reported folic acid supplement usage prior to pregnancy was lower in younger age groups and in Maaori and Pacific women. Therefore the effectiveness of this as a policy option is very limited. 2. Voluntary fortification has not achieved its objectives Voluntary fortification has been in place in New Zealand since 1996, as well as a voluntary agreement with industry to increase the volume of packaged sliced bread being fortified under the industry Code of Practice since 2012. These initiatives have failed to increase the folate status of women of reproductive age to the level required to prevent NTD-affected pregnancies.9 While the target food group is appropriate (bread is the most widely consumed food amongst women of reproductive age that can be fortified),m the voluntary regime has not achieved its goal of 50% fortification by volume of packaged sliced bread. By 2017 only 38% of packaged sliced bread was fortified, and the discussion document highlights that levels of fortified bread have plateaued since 2015 as well as many of the products being fortified below the target level.11 In addition, international evidence from Europe highlights that public health approaches promoting folic acid supplementation and voluntary fortification have not been effective in decreasing the prevalence of 3. Mandatory fortification provides maximal benefit Mandatory folic acid fortification has been adopted in 81 other countries with clear evidence that folic acid fortification is safe and reduces the prevalence of NTD-affected pregnancies and shifts those NTD births that do occur to the less severe end of the scale.13 There have been several missed opportunities with regard to this policy option in New Zealand. As reported in the MPI technical document, it is estimated that 134?180 pregnancies affected by an NTD could have been prevented over the last ten years in New Zealand if mandatory fortification of bread-making flour had occurred in 2009 when it came into effect in Australia.14 In addition, fortifying a staple food can be an equitable way to maximise the preventative benefit of folate for women of reproductive regardless of supplementation use, pregnancy planning and knowledge of fortified food options.15 The equity benefits of mandatory fortification are demonstrated in Australia with an even greater decline in the NTD rate within indigenous communities because of their 7 MPI. Folic acid fortification: Technical supporting document. New Zealand Food Safety Technical Paper No 2019/04. Prepared for Food Policy, Ministry for Primary Industries by Michelle Gibbs, Rebecca Doonan and Peter van der Logt Food Science and Risk Assessment. October 2019. 8 E, Hohmann?Marriott. Unplanned pregnancies in New Zealand. Aust NZJ Obstet Gynacol 2018: 247-250. 9' 2014/15 New Zealand Health Survey shows blood folate levels amongst women of childbearing age are currently insufficient to prevent affected pregnancies (data supplied by the Ministry of Health to MPI). MPI. Folic acid F?ortification: Increasing folic acid availability' In food. New Zealand Food Safety Discussion Paper No: 2019/08. 0.MPI Folic acid fortification: Technical supporting document. New Zealand Food Safety Technical Paper No 2019/04. 11Voluntary fortification of bread with folic acid: Annual Report 2017. New Zealand Baking Industry Research Trust. May 2018. 12 Khoshnood B, Loane M, Walled Hd, Arriola L, Addor M-C, Barisic I, et al. Long term trends in prevalence of neural tube defects in Europe: Population based study. BMJ. 2015; 351. 13 MPI. Folic acid Fortification: Increasing folic acid availability in food. New Zealand Food Safety Discussion Paper No: 2019/08. 14MP.I Folic acid fortification: Technical supporting document. New Zealand Food Safety Technical Paper No 2019/04. 15.WHO Guidelines on Food Fortification with Micronutrients. World Health Organisation 2006. higher preceding NTD rate.16 Therefore, continued delay of this policy option would mean that pregnancies continue to be affected by preventable birth defects with ongoing inequities for Maaori. Other potential health benefits of improved population folic acid intake include reduction in non-NTD birth defects, reduced risk of other adverse pregnancy outcomes, and reduced risk of strokes, cardiovascular disease, osteoporosis and cognitive decline. 17 Mandatory folic acid fortification is clearly justified given: 0 it is an important way to address existing health inequities 0 there is evidence of efficacy and safety of fortification from countries who have adopted mandatory fortification US, Canada, and Australia) 0 it is cost-effective and it is likely that cost-effectiveness estimates are conservative fetal deaths are only counted after 20+ weeks)18 0 sufficient time and investment has been given to the voluntary fortificatio?e??pproach in New Zealand with limited success 0 consumers who make a choice to opt off will still be able to be able to purchase non-fortified alternatives organic bread) 0 it is in line with the consensus position of the World Health Organization, the Food and Agricultural Organisation of the United Nation (FAO), the United Nations Children?s Fund (UNICEF), Global Alliance for Improved Nutrition (GAIN), the Micronutrient Initiative, and the Flour Fortification Initiative.? Specific comments We wish to raise the following matters under the consultation questions included in the discussion document. 1. Do you agree with the problem as stated? The problem statement is incomplete. The problem we are trying to solve is about equitably reducing the number of folic acid?sensitive NTD-affected pregnancies and the wide range of impacts of NTDs on women, babies, whaanau and society, including through termination, stillbirth, perinatal death and life-long 15 Ministerial Council (Australia and New Zealand Food Regulation Ministerial Council) (2017). The effectiveness and cost-effectiveness of mandatory folic acid and iodine fortification. Online ISBN: 978-1-76007-323-7. 17 The Health Benefits and Risks of Folic Acid Fortification of Food: A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. June 2018. 18 Moore D, Young M. Folic acid fortification: both society and individuals benefit. Report prepared for the Ministry of Primary Industries by Sapere. May 2019. 19 World Health Organization, Food and Agricultural Organisation of the United Nation, The United Nation?s Children?s Fund, Global Alliance for Improved Nutrition, The Micronutrient Initiative, Flour Fortification Initiative. (2009) Recommendations on wheat and maize flour fortification. Meeting Report: Interim Consensus Statement. Geneva, World Health Organization. Acsessed 6 November 2019. Available from: maize fort.pdf disability. Therefore it is important the problem statement explicitly mentions the inequities in NTD prevalence for Maaori. It also needs to highlight that both folic acid supplementation and voluntary fortification have limited effectiveness in decreasing the population prevalence of NTDs (in its current form it only mentions supplementation). 2. Do you agree with the objective of the review? Yes, however it needs to emphasise the critical importance of reaching all women of reproductive age and reducing inequities in NTD prevalence and NTD severity. Also, as per the report of the Chief Science Advisor, Maaori need to be centrally involved in the decision-making process to ensure Maaori receive equal benefit from the decision.? Option 1: Maintaining the status quo and Option 2: Asking industry to enhance voluntary forti?cation to 80% forti?cation International evidence and our experience in New Zealand demonstrate the voluntary fortification approach has very limited effectiveness in decreasing NTD prevalence. It is unclear and unlikely that intensifying this approach would achieve the intended benefits (fortification levels of 80% by volume of packaged sliced bread) and as a result achieve the desired health benefits in a timely manner. Option 3a and 3b: Introducing mandatory forti?cation of all non-organic bread or mandatory fortification of all non-wheat flour for bread-making We support the mandatory fortification of bread and support Option 3a (all non-organic bread) and option 3b (all non-wheat flour for bread-making). These options both have the potential to reduce NTD-affected pregnancies and have minimal risk of overconsumption of folic acid by a non-target group. Mandatory fortification is evidence-based and more likely than other options to address existing health inequities. We recommend reviewing the folic acid concentration of the seiected food vehicle post-fortification in accordance with the monitoring data of health outcomes, changing dietary patterns, and changes in the folate status of target and non-target groups to ensure maximal benefits are being achieved. Option 3c: Introducing mandatory folic acid fortification of non-organic wheat flour We note the concern about the overconsumption of folic acid by a non-target group within this policy option. With any approach it is important to balance the benefits and risks at a population level. However, it is currently unclear from the discussion document what the actual health risk is, if any, from overconsumption of folic acid by children (above the nominal upper level of intake?). We also note that all white flour and pasta is fortified in Canada with no evidence of harm, and also the recommendations made by the Scientific Advisory Committee on Nutrition (SACN) in the UK that the risks of overconsumption can 2? The Health Benefits and Risks of Folic Acid Fortification of Food: A report by the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi. June 2018. 21 We note the quite theoretical and 'precautionary? approach used to set the maximal limits in children based on Vitamin B12 deficient older adults, in the absence of any evidence of harm due to such doses in children be mitigated if fortification is accompanied by controls on voluntary fortification, guidance on supplement use and appropriate population monitoring (the UK does not have a lower tolerable upper intake level for children as they have found no data supporting adverse effects in children).22 It is important that we are providing the optimal dose of folic acid to the population for the prevention of NTDs at a level that is safe. Since the health gains would be higher under this option, we recommend that MPI continue to gather evidence to more completely understand any potential risks of this policy option in case it would be an appropriate future policy option, by: - continuing to follow-up the evidence on whether there are any adverse health impacts associated with overconsumption of folic acid, or indeed whether additional benefits may accrue 0 ensuring that estimates ofthe upper level of intake for children and other population groups are based on the best available evidence 0 monitoring and continuing to take into account changes in dietary consumption patterns - monitoring approaches in overseas jurisdictions to universal fortification 0 determining whether any additional measures could be taken to mitigate the risk of overconsumption of folic acid in non-target groups. 9. Do you agree with the approach to implementation? We recommend the monitoring of the chosen implementation approach, to ensure it continues to achieve its objectives in terms of effectiveness and equity, to identify any unintended consequences and to confirm it is in line with international best practice and the best available evidence on folic acid fortification. Recommendations The Population Health Directorate of CM Health appreciates the opportunity to submit on this important and preventable public health issue in New Zealand. We also commend MPI on the clear and evidence- based Discussion Document and companion Monitoring and Evaluation Report provided for comment. Mandatory folic acid fortification has been shown to be safe and cost-effective and is the only policy option to reach the whole population in order to protect those women most at risk. We strongly recommend the introduction of mandatory fortification in New Zealand to receive the health, social, economic and equity benefits of improved folate status and reduced NTDs. in order to achieve the maximal possible preventative benefit for NTDs, our directorate has several recommendations for the implementation of mandatory folic acid fortification: 22 Scientific Advisory Committee on Nutrition. Update on Folic Acid, 2017. Accessed 6 November 2019. Available from: data/file/637111/SACN pdate on folic acid.pdf Monitoring of the overall incidence of NTDs as well as the folate status in the target population in order to evaluate the impact of folic acid fortification policies Reviewing whether restrictions on voluntary dietary fortification with folic acid are required, and monitoring the folic acid intakes and blood folate concentrations of the population Reviewing the folic acid concentration of the fortified food vehicle to ensure it is providing the optimal benefits for the population Reviewing the guidance on the use of folic acid supplements for women who could become pregnant or are currently pregnant .t Increasing awareness among women of reproductive age of the importance of folic acid and its role as an essential vitamin Reviewing the labelling options on bread packaging to also advise women who are pregnant or planning to become pregnant to discuss folic acid supplementation with their health care provider Ongoing review of scientific literature about the benefits and harms of folic acid. Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: 0 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread. or - introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that folic acid, when fortified in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email in: While we prefer email, you can also post your s??inis?sion to: Consultation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Jackie Mayne or contact person: Organisation (if applicable): Regional Public Health Email: 5 Of?cial Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months? following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily fortified with folic acid. This is not enough, however, to sufficiently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. Disagree. Unsure. Please explain why: As a Public Heatth Unit (PHU) we are charged with protecting the health of our resident population inciuding minimising the impacts of nutrition-related diseases. As such, Regional Public Health (RPH) supports the mandatory forti?cation of foiic acid in bread but we disagree with the problem stated, as we consider there is an insuf?cient focus on equitable outcomes in the problem statement, particularly for Maori whanau. We would welcome the opportunity to talk with you more about the equity analysis of mandatory forti?cation on folic acid in bread. RPi-i has of?ces in the Wellington region and could easily host a meeting. Neural tube defects (NTD) are experienced more commonly in Maori whanau. Maori women. have a statistically signi?cant higher live birth prevalence of NTDs compared to New Zealand European women.i The tong-tam heaith impacts of NTDs has the greatest impact on their whanau and hapu who already disproportionately experience higher rates of inadequate housing, lower socioeconomic status and are over represented in poor health outcomes. NTDs are not a one~off health event, analogous to an infectious disease (cg. measles),a heart attack or a hip operation. An NTD has signi?cant impacts on the chiid's health, wellbeing, sociat and educational opportunities across their whole lifespan and that of their whanau. Effective lifetime management of may include house remodelling, on?going doctor and hospital visits, wheelchair and mobility supports, modi?ed vehicles, education and social support amongst other things. The ?nancial impact of these extra daily needs will impact the whoie whanau in an on-going way. The ?nancial pressures associated with NTDs will have a muitiptier effect for whanau who may already be experiencing other signi?cant ?nancial and social pressures. The higher rates of NTDs experienced by Maori whanau, means they carry the greater burden of this preventabte condition in Aotearoa. This is counter to the intent of Te Tiriti Waitangi. To achieve equity, the prevalence of NTDs needs to decrease for Maori women to rates equivalent to those for New Zealand European women. We consider the appropriate goal of any population wide health poticy, should be the targeted reduction of the health impact on those who experience it the most. Given that over 50% of births are unplanned, we consider that counting and comparing the number of projected NTDs experienced with the options presented is an inappropriate policy goal. We recommend the analysis shoutd focus on how to best reduce or eliminate NTDs in Maori whanau. We believe a focus on Maori whanau and their experience of NTDs (analogous to developing a wahakura and pope pods to address in Maori whanau?) would be a more appropriate policy goal. The United Nations af?nned the rights to both sovereignty and heaith for indigenous peopie in The declaration on the Rights of Indigenous Peoples, New Ze-alandi" rati?ed this declaration in 2010. Maori carry a disproportionate burden of preventable disease, NTDs being one. Evidence has demonstrated based on outcomes of mandatory folic acid forti?cation in Austraiia and the United States, indigenous popuiation have the greatest to gain." Therefore we support the further analysis you have committed to undertake as a key outcome foltowing the feedback on this consultation. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE El Agree. Disagree. El Unsure. - Please explain why: RPH disagrees with the objective of this review. As a population heaith agency we consider the appropriate focus for ali population health interventions should be increasing the equity of health outcomes. We consider that the weighting of equity against consumer choice and industry impacts is an inappropriate objective of this review. Given that approximately hatf of all pregnancies in New Zealand are unplanned, and women are uniikely to take folic acid suppternent until late into their first trimester, consumer choice is not a relevant consideration in seeking to reduce the numbers of NTDs experienced in Aotearoa. L?tewise, weighting health outcomes equivalently with industry impact creates a bias towards short term industry impact and away from the lifetime impacts of on children and their whanau. Governments should adapt the least burdensome measure from the measures that are available and reasonable to mitigate the risks in question?. Whilst governments must strive to ensure there is a reasonable ?t between the coercive measure imposed on individuais, and the public health bene?t they seek to achieve, the objective should appropriately be addressing the public health impact not the needs of industry or consumers. In our opinion, the legal principle of measuring the proportionate level of risk to that of this intervention has not been weighted equitably. Again we would welcome the opportunity to discuss this with you. Option 1: Maintaining the status quo Option 1 would involve continued vciuntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE CI Agree. Disagree. Unsure. Please explain why and provide any evidence you may have: RPH considers that the assessment of the status quo is not cunently fut?lling treaty obligations and is not equitable for Maori woman and unplanned pregnancies. The status quo has not effectively reduced the rate of NTDs. We consider that the weighting of equity against consumer choice and industry impacts is an inappropriate objective of this review. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the targe plant bakers) to voiuntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 ievel of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 -- 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY El Agree. Disagree. Unsure. Please explain why and provide any evidence you may have: RPH considers that the weighting of consumer choice, equity and industry impacts in this assessment framework should be reviewed. The assessment of the enhanced votuntary fortification option is not currently futfilling treaty obligations and is not equitable for Maori woman and unpianned pregnancies. We note the paper states enhanced voluntary forti?cation Is unlikely to be taken-on by industry, therefore the result will be close to status quo. As Maori are noted as experiencing higher rates of NTDs, along with many other disparities, this approach suggests that Maori are being denied their equal rights to health, as enshrined in Te Tiriti Waitangi. The 2017 audit by the Baking Industry Research Trust"ii reported the mean folic acid content for all bread under the current status quo was 164ug per 1009, below the target of 200ug. This is in addition to only 38% of fortified packaged bread being achieved instead of the 50% goal, The goals and targets have not been achieved with the status quc therefore increasing these goals with enhanced forti?cation means further reductions' In NTD incidence will be minimal, with little health outcome improvements for Maori and their whanau. Option 33: Mandatmy forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. it would apply to all non- organic bread products, and include bread made from cereals other than wheat com and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed op?on 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and othet impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. Disagree. l3 Unsure. Please explain why and provide any evidence you may have: RPH considers that the weighting of consumer choice, equity and industry impacts in this assessment framework should be reviewed. The assessment of mandatory fortification of non- organic bread option is not currently ful?lling treaty obligations and is not equitable for Maori woman and unplanned pregnancies. Whilst RPH strongly supports mandatory forti?cation, option 3a would be our least preferred choice of the mandatory options proposed. As a PHU we consider the appropriate focus for all population health interventions should be increasing the equity of health outcomes. We consider option So will not equitably reduce NTD incidence as evidenced by the greater projected NTD saving with options 3b and 3c and the higher NTD incidence rates experienced by Maori whanau. Additionally the technical challenges to industry and the net cost rather than savings makes this option the least favourable. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be fortified with folic acid at the flour-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be fortified with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be fortified. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION 0F BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: RPH considers that the weighting of consumer choice, equity and industry impacts in this assessment framework should be reviewed. The assessment of mandatory forti?cation of non- organic bread option is not currently ful?lling treaty obligations and is not equitable for Maori woman and unplanned pregnancies. We consider the appropriate goal of any population wide health policy should be the targeted reduction of the health impact on those who experience it the most, therefore the focus should be on how to best reduce or eliminate NTD's in Maori whanau. As an effective population health measure option 3b Mandatory fortification of non-organic bread- rnaking wheat flour is our second proffered choice as this still has an unacceptable projected rate of NTDs. Although this is the MPI preferred option, we believe the basis for this is based on expediency instead of a population health and equity lens. to our opinion, we believe that by indicating that this is your preferred option, you will have created a strong bias for responders. severely in?uencing their submission responses, and that responses to this submission will be skewered towards Option so. As you have outlined within Option 3b, the ?Health impact? of prevented over 30 years is between 162 to 240 pregnancies, with net savings of $32.2 to $54.6 million over the same 30 year period. When Compared to Option 3c, which outlines that the ?Health impact' of NTDs prevented would be 252 to 405 pregnancies (almost double) with net savings of between $54 to $97.9 million (again, almost double) over the same 30 year time period, it is dif?cult to determine why Option 3c is not recommended as your preferred choice, given that all wheat based products would be forti?ed (leaving little to chance). We consider the preferred option so as presented has an insufficient focus for equitable health outcomes for Maori and their whanau. Upper Limit Uncertainty. We consider the focus on the upper limit (UL) for folic acid end point as being questioned in the report is a distraction from the key issue. A ?recent re-analysis? suggests that data originally used to set the upper levels (UL) was incorrectly interpreted. After the correct adjustment, no association between higher doses of folic acid and the health outcome was evident. In addition, it is noted that exceeding the UL is not considered as a health risk due to the wide safety margin. We need to take preventative action in the face of uncertainty. AS outlined above, we that option 3c would have almost double the number of preventable NTDs and almost double net savings. What we can't be certain of due to lack of evidence is the impact of some individuals exceeding the upper limit of folic acid. However, the known impact of not fortifying all wheat flour, of around 206 more NTDs over a 30 year time period, is very likely to have a greater negative impact on the health of the population compared with projected exceedances of the upper limit, especially considering the unreliability of the upper limit. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the fortification of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: 10 As a population health agency we consider the appropriate focus for all population health interventions should be increasing the equity of health outcomes. We consider that the weighting of equity against oonsuner choice and industry impacts is an inappropriate objective of the review. RPH supports the mandatory forti?cation of folio acid in broad but we disagree with the problem as stated. There is an insuf?cient focus on equitable outcomes in the problem statement, particularly for Maori whanau. We recommend that the Mandatory forti?cation of all non-organic wheat ?our (regardless of and purpose) is implemented, as this would provide the greatest bene?t for all pregnancies, planned and unplanned throughout NZ and would provide a greater equitable outcome. NTDs are experienced more commonly in Maori whanau. Maori women have a statistically signi?cant higher live birth prevalence of NTDs compared to New Zealand European women.ix The long-term health impacts of NTDs has the greatest impact on Maori", their whanau and ham who already disproportionately experience higher rates of inadequate housing. lower socioeconomic status and are over represented in poor health outcomes. RPH strongly recommends Option 3c - Mandatory forti?cation of all nomrganic wheat flour (regardless of end purpose) as OUR preferred option. Throughout the consultation document you have outlined that the Option modelling demonstrated that the 'Health impact? of NTDs prevented woutd be almost double of Option 3b, with net savings again almost double over the same 30 year time period, than that of Option 3b. Therefore option 3c Mandatory forti?cation of all non-organic wheat flour is our preferred option as it: 6 Will improve equity for Maori and will fulfil our treaty obligations. This option will result in less burden of disease for Ma?rori and therefore more equitable health outcomes. Has the greatest cost saving of up to 97 million over 30 years, compared to 73 and 55 for option a) and b) respectively. - The greatest health impact, reducing up to 405 NTDs over 30 years compared respectively. - Broadens the folic acid vehicle to include all wheat based products, therefore allowing for changing demographics and food consm'nption patterns in NZ. Recommendations: 0 Reduce the quantity of folic acid added to wheat ?our to lower the likelihood of exceeding UL and repeat modelling scenarios for this level. 0 Ensure Maori are involved in this decision-making process and that this is not seen as a reduction in power and control. Increase understanding that mandated forti?cation would provide the greatest benefit for Maori, whanau and ham]. In the US and Australia where folic acid fortification is mandated indigenous populations have proportionately at the greatest reduction in NTD rates *5 11 RPH would like to re-iterate the following: The recent re-analysis of the UL level suggests the data originally used to set the UL were incorrectly interpreted, and the UL therefore lacks a scienti?c basis. As stated in the report by the PMCSA ?Wald at al found that in determining the Lowest Observed Adverse Effect Level, the failed to take into account the numbers of patients in each folic acid dose group. When this factor was included, higher doses were no longer associated with higher rates of neuropathological progression, and no dose~response relationship could be observed.? This means the basis on which the UL was determined is invalid. - tn addition there is a lack of evidence of adverse clinical effects in children, and the UL for children has been derived from the adult level adjusted for body weight. Therefore the current UL is not evidence based and is a very tenuous measure on which to eliminate a population health intervention. As the PMSCA report states re-evaluation and possibly abolition of the UL wilt have major implications for health risk assessments of folic acid; RPH also note the science modelling used to estimate intakes for different age groups was based on the worst case scenario that all flour based goods consumed would be domestically produced forti?ed flour and the flour would be forti?ed to the maxim um level. New Zea lenders consume a signi?cant number of imported products. We propose to reduce the folic acid added to flow to the minimum level or less to mitigate this overconsumption for 5-8 year olds. 12 Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that couid be affected, what do you estimate the increased costs to be? No comment, as this is not our area of expertise General comments if you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availabilinl in food discussion paper, please let us know. i Ministry of Primary Industries (2018), Voluntary Folic Acid Forti?cation? Monitoring and Evaluation Report. No: 978-1-77665-764-3 a PMCSA (Of?ce of the Prime Minister?s Chief Science Advisor and me Royal Society Te Aparangi) (2018). The health bene?ts and risks of folic acid forti?cation of food [Internet]. (if-foodmf 13 i? 39/2/e201 60162 Wahakura Versus Bassinet for Safe Infant Sleep: A Randomized Trial Sally A. Baddock, David Tipene?Leach, Sheila M. Williams, Angeline Tangiora, Raymond Jones, Ella losua, Emily C. Macleod and Barry J. Taylor. Pediatrics February 2017, 139 (2) e20160162; DOI: hts-of?indiqenous? peoples. PMCSA (Office of the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi) (2018). The health benefits and risks of folic acid fortification of food [Internet]. of-foodpdf Vi data/assets/gdf file/0003191173/E83079.Qdf nz/files/file/747/201 7+Voluntarv+fo rtification+of+b read+with+folic+acid+an nu al+report+FINAL.pdf Vi? PMCSA (Office of the Prime Minister?s Chief Science Advisor and the Royal Society Te Ap?rangi) (2018). The health benefits and risks of folic acid fortification of food [Internet]. pm csa . ore . nszb-conte nti upload e? health-benefrts-a of?food.gdf ix Ministry of Primary lndustrie (2018), Voluntary Folic Acid Fortification- Monitoring and Evaluation Report. ISBN No: 978-1-77665-764-3 PMCSA (Office of the Prime Minister?s Chief Science Advisor and the Royal Society Te Aparangi) (2018). The health benefits and risks of folic acid fortification of food [Internet]. csaorq. nszp-co ntentf upload sz of?foodpdf . "i The Health Benefits and Risks of FoIic Acid Fortification of Food, A Report by the Office of the Prime Ministers Chief Science Advisor and the Royal Society Te Aparangi 1' ?Lh 14 Submission Form introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming sufficient folio acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be significant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: a continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread - ask industry to enhance the voluntary approach to fortify 88% of packaged siiced bread, or . introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public witl help us understand the possible impacts of the proposals. Once you have completed this form Email is: While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Rh?di or contact person: Submitted by: Rhodi Bullooh (NZ Registered Dietitian) and Associate Professor Clare Wall (NZ Registered Dietitian) (T he Discipline of Nutrition and Dietetics, The University of Auckland), Professor Lesley McGowan (Sub-speciaiist in Maternal Fetai Medicine) (Department of Obstetrics and Gynaecology, The University of Auckland) and Associate Professor John Thompson (Biostatistician and Paediatn'c Epidemiologist) (Department of Obstetrics and Gynaecology, The University of Auckland) Organisation (if applicabte): Email: r.bulloch@auckland.ac.nz Official Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Official Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folete levels of women of childbearing age was improved. Most women of childbearing age cannot get enough foiate from natural food sources to ensure optimai blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD?affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. El Unsure. Please explain why. Research indicates that women of childbearing age in New Zealand are not receiving the recommended amount of folate through their diet (Russell et at, 1999), and research on red blood cell folate levels of NZ women of childbearing age shows that many women do not have the optimal red blood cell folate levels required for the prevention of NTDs in early pregnancy (Bradbury et al, 2013). Research also indicates that folic acid supplementation is associated with higher plasma folate levels (Bulloch et al, 2019). However, only an estimated 31-48% of New Zealand women take folic acid supplements pre-conception and during the ?rst trimester in accordance with the recommendations of the New Zealand Ministry of Health (T eixeira et ai 2018, Bulloch et al 2019). Poe-conception folic acid supplementation rates as low as 6.3% have been reported in women with unplanned pregnancy (T eixeira 2018), and approximately 50% of pregnancies in New Zealand are unplanned (Hohmann? Marriott et al 2018, Morton et al 2013). Access to pre-pregnancy folic acid supplementation is currentiy inequitable, as pregnancies are less likely to be planned in communities with high deprivation. In addition, NTD rates are higher in Maori women, a further indicator of health inequity. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTWE OF THE Agree. ill Disagree. Unsure. Please expiain why. We support the need to reduce NTDs in NZ and reduce inequities from this disabling condition. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed op?on 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. [3 Disagree. Ci Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory forti?cation. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would invoive asking industry (currently the large piant bakers) to voluntarily increase the volume of packaged siiced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goat of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory forti?cation. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zeaiand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals}. has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Piease explain why and provide any evidence you may have: We agree with the assessment but support mandatory fortification Option 3b. Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat flour for bread-making would be forti?ed with folic acid at the flour-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of foiic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 313 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 - 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. CI Unsure. Please explain why and provide any evidence you may have: As researchers and clinicians working in the ?eld of pregnancy and nutrition we have read the literature and support this recommendation: Mandatory Folic Acid Forti?cation Option 3b. Please see information and references provided under General Comments at the end of this questionnaire, to support our choice. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option 3c would require the fortification of ali non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of foiic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. [1 Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment but support mandatory fortification Option 3b rather than Option 3c which could result in a higher number of young children exposed to higher levels of folic acid through forti?cation. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. Ct Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? General comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. Please see comments in box on next page As researchers and clinicians working in the field of pregnancy and nutrition we support: Mandatory Folio Acid Forti?cation Option 3b. This is based on the modelling work conducted by MPI as outlined in the supporting documentation provided by MPI and previous research conducted in this area: 1. 10. In New Zealand, women of childbearing age receive folate through their diet as well as folic acid through voluntarily forti?ed foods (if they consume these), and from supplementation (if they take folic acid containing supplements). Published data from twenty years ago from the 1997 National Nutrition Survey estimated that the usual median intake of New Zealand women receive approximately 212 micrograms of food folate (from food sources) per day (Russell et at, 1999). This level is below the folate ROI for women (400 micrograms per day as dietary folate equivalents) as well as the ROI for pregnant women (600 micrograms per day as dietary folate equivalents) 2006). This means women of childbearing age must receive the difference through folic acid forti?cation or supplementation in the absence of dietary change. A New Zealand study found that New Zealand women of childbearing age have sub-optimal levels of red blood cell folate for the prevention of neural tube defects (Bradbury et al, 2013). Previous research indicates that daily folio acid intake contributes to red blood cell folate levels (Houghton et al, 2011). Adequate pro-conception folio acid intake at least 4 weeks prior to conception is required for optimal folate status for prevention of NTDs (Ministry of Health, 2008; WHO, 2015). A double-blinded, placebo?controlled trial conducted in New Zealand women of childbearing age found that after 40 weeks of consuming an average daily intake of 140 micrograms of folic acid per day (a similar dose to that which would be supplied by mandatory forti?cation), the prevalence of RBC folate below the optimal level for NTDs (<906 nmol/L) decreased 2- fold from 67% (at baseline) to 35% (at 40 weeks) (Hursthouse et al, 2011). An estimated 31-48% of New Zealand women take folic acid supplements pro-conception and during the ?rst trimester in accordance with the recommendations of the New Zealand Ministry of Health (T eixeira et al, 2013: Bulloch et al 2019). Pro-conception folio acid supplementation rates as low as 6.3% have been reported in women with unplanned pregnancy (T eixeira et al. 2018). Approximately 50% of pregnancies in New Zealand are unplanned (Hohmann-Marriott et al, 2018, Morton et al, 2013). Pro-conception folio acid supplementation use and therefore folic acid intake is a health equity issue in New Zealand - pre-oonception folio acid supplement use is estimated to be lower amongst Maori and Pacific women, women from low socioeconomic groups, and younger women. (T eixeira et al, 2018; Bulloch et at, 2019; Morton et al, 2013). Mandatory folio acid forti?cation will help to reduce these inequities in folic acid intake, as well as in NTD rates, by increasing pro-conception and early pregnancy intake of folio acid across a range of ethnic groups, strata, age groups and education levels in New Zealand (Morton et al, 2013; Houghton et al, 2011; Teixeira et al, 2018; Bulloch et al, 2019). A study in pregnant women conducted by Pentieva et al (2015) found that a daily folio acid supplement dose of 400 micrograms per day, in addition to folic acid from forti?ed foods (40- 272 micrograms per day), did not significantly increase levels of un-metabolised folic acid concentrations in maternal or cord blood, despite improving folate status of both mothers and their newborn. There was no signi?cant effect of folio acid from supplements or forti?ed foods on plasma unnmetabolised folio acid concentrations. The New Zealand Ministry of Health?s recommended dose for folio acid supplementation is 890 micrograms per day (started at least four weeks prior to conception and continued to the end of the ?rst trimester) (Ministry of Health, 2008). Research on a sample of New Zealand pregnant women (data collected between 2004 and 2009) showed a daily mean intake of suppiemental folic acid of 564 micrograms (SE 13.3) per day (at 15 weeks' gestation). (Builoch et al, 2019) 11. It will be important to monitor the folic acid intake and folate status of the New Zeaiarrd population of all ages and its response to the introduction of mandatory folic acid forti?cation, especially in pregnant women. 12. in 2016 the World Health Organisation released its Antenatal Care Guidelines for a Positive Pregnancy Experience (WHO, 2016) which recommends that folic acid supplementation is started pro-conception, and that it is taken throughout pregnancy for best pregnancy outcomes. Although beyond the scope of the work and modelling conducted by for this review, for women who do not take folic acid supplementation prior to or during pregnancy, mandatory folic acid forti?cation will provide many pregnant women with a daily source of folio acid to help ensure adequate maternal folate status and best pregnancy outcomes beyond the prevention of NTDs. (Hodgetts at al, 2015; Bulloch at at, 2018). We strongly support Option 3b based on the information provided by on the different options, due to: 1. the number of NTDs this strategy could prevent, 2. under this option fewer children will be exposed to the folic acid UL than Option 3c, and that 3. data shows that under the voluntary fortification options fewer NTDs are prevented than by mandatory fortification References: Bradbury KE, Williams SM, Mann Jl,et al.(2013) Estimation of serum and folate concentrations in the New Zealand adult population within a background of voluntary folic acid forti?cation. Nutr 144,68?74 Bulloch, R. E., McGowan, L. M, Thompson, J. M., Hooghton, L. A., 8: Wall, C. R. (2019). Plasma Folate and its Association with Folic Acid Supplementation, Sociodemographic and Lifestyle Factors among New Zealand Pregnant Women. British Journal of Nutrition, t~26. Bulloch, R. E., Lovell. A. L, Jordan, V. M., McGowan, L. M, Thompson, J. M., Wail, C. R. (2018). Maternal folio acid supplementation for die prevention of preeclampsia: A systematic review and meta-analysis. Paediatric and perinatal epidemiology, 32(4), 346-357. Hohmann-Marriott, B. E. (2018). Unplanned pregnancies in New Zealand. Australian and New Zealand Joumal of Obstetrics and Gynaecology, 58(2), 247?250 Houghton, L. A., Gray, A. R., Rose, M. 0., Miller, J. Hurthouse, N. A., Gregory lit, .3. F. (2011). Long-tenn effect of low-dose folic acid intake: potential effect of mandatory forti?cation on the prevention of neural tube defects. The American journal of clinical nutrition, 94(1), 136-141. Hursthouse, N. A., Gray, A. R., Miller, J. 0., Rose, M. C., Houghton, L. A. (2011). Folate status of reproductive age women and neural tube defect risk: the effect of long-term folic acid supplementation at doses of 140 pg and 400 pg per day. Nutrients, 49-62. Ministry of Health (2008) Food and Nutrition Guidelines for Healthy Pregnant and Breastfeeding Women: A Background Paper. Wellington: Ministry of Health. Morton, S. M, Grant, C. 0., 8. Atatoa Carr, P. E. (2013). Too many left at risk by current folic acid supplementation use: evidence from Growing Up in New Zeaiand. Australian and New Zealand joumal of public health, 37(2), 190-191 . National Health and Medical Research Council Australian Govemment Department of Health and Ageing, New Zealand Ministry of Health (2006) Nutrient Reference Values for Australia and New Zealand. Canberra: National Health and Medical Research Council; Wellington: Ministry of Health Pentieva K, Selhub J, Paul L,et al.(2016) Evidence from a randomized trial that exposure to supplemental folic acid at recommended levels during pregnancy does not lead to increased unmetabolized folic acid concentrations in maternal or cord blood.J Nutrt46, 494?500 Russell, D. G., Parnell, W. R., Wilson, N. 0., Feed. J., Ferguson, E., Herbison, Wilson, B. (1999). NZ food: NZ people. Key results of the 1997 national nutrition survey. Wellington: Ministry of Health. Teixeira, J. A., Castro, T. G., Wall, C. R., Marchioni, D. M, Berry, 3., Morton, S. M., Grant, C. C. (2019). Effects of folic acid food forti?cation scenarios on the folate intake of a multi-ethnic pregnant population. Public health nutrition, 22(4), 738-749. Teixeira, J. A., Castro, T. G., Wall, C. R., Marchioni, D. M., Berry, 8., Morton, S. M., a. Grant, 0. C. (2018). Determinants of folic acid supplement use outside national recommenda?ons for pregnant women: results from the Growing Up in New Zealand cohort study. Public health nutrition, 21(12), 2183-21 92. Word Health Organization (2015) Guideline: optimal serum and red blood cell folate concentrations in women of reproductive age for prevention of neural tube defects. Geneva: World Health Organisation. l'bc womenreg tubedefectslenl World Health Organization (2016) WHO recommendations on antenatal care for a positive pregnancy experience. Geneva: World Health Organization. 10 RACP Specialists. Together The Royal Australasian College of Physicians? submission to the Ministry for Primary Industries Folic acid fortification: lncreasing folic acid availability in food Introduction The Royal Australasian College of Physicians (RACP) welcomes the opportunity to submit feedback to the Ministry for Primary Industries (MPI) on folic acid forti?cation. The RACP works across more than 40 medical specialties to educate, innovate and advocate for excellence in health and medical care. Working with our senior members, the RACP trains the next generation of specialists, while playing a lead role in developing world best practice models of care. We also draw on the skills of our members, to develop policies that promote a healthier society. By working together, our members advance the interest of our profession, our patients and the broader community. Key Points The RACP strongly supports action to increase the intake of folic acid across the population of Aotearoa New Zealand with the aim of reducing the rate of neural tube defects (NTDs). NTDs are serious health problems, which are demonstrably reduced by the intake of adequate levels of folic acid during pregnancy. Reducing instances of neural tube defects is important for a number of reasons, including 0 their inequitable impact on Maori . the impact they have on the quality of life and overall wellbeing of sufferers . the economic and emotional burden they place upon caregivers Background Impact of neural tube defects NTDs have wide-ranging impacts upon sufferers, including affecting their physical, emotional, social and sexual functioning?. People with NTDs often require help with their basic daily functioning and suffer from a range of long term health problems including urinary tract infections, kidney stones and skin infections. This severely impacts on wellbeing and quality of life, which could be avoided by the intake of folic acid before and during pregnancy. Diagnosis of NTDs are also likely to cause great distress in parents and caregivers, who are presented with a range of options including the grief of termination or stillbirth, or the signi?cant emotional and financial investment and commitment to caring for a child with a NTD. Children with NTDs are often affected by other conditions, which increases strain upon carers and contributes to a significant impact on the carers stress levels, mental health and a range of other negative in?uences. In economic terms, caregivers experience reduced income due to the additional time burden, which is further compounded by the substantial direct costs of medical treatment for a child with a NTD. These factors contribute to a lower quality of life and exemplify the importance of reducing the incidence of NTDs, by improving intake of folic acid. Comparative rates of neural tube defects in Aotearoa New Zealand As noted in the discussion document provided by MPI, the New Zealand rate of NTDs is comparable to that of other countries who employ voluntary folic acid fortification, but significantly above that of countries who employ mandatory fortification. It has been conclusively proven that intake of 1 Rofail D, Maguire L. A Review of the Social, and Economic Burdens Experienced by People with Spina Bifida and Their Caregivers. [Internet] Neurol Ther. 1-12. Available from: Accessed 11 November 2019 The Royal Australasian College of Physicians 2 Submission to the Ministry for Primary Industries periconceptional folic acid has a significant impact on preventing NTDs, as established by numerous studies2 As such, there is a readily available blueprint, both for the impact of folic acid fortification, and for its implementation, which can be applied to reduce the rate of neural tube defects and improve health outcomes for women in Aotearoa New Zealand. Inequitable impact on Maori NTDs inequitably affect the births of Maori, and subsequently, the lives of their children3. This has a significant social impact, and mirrors trends found throughout the health system in Aotearoa New Zealand. Achieving equity by improving the rates of folic acid intake in Maori is a key argument for mandatory fortification, as this would maintain the equity focus, and the commitment to Te Tiriti Waitangi laid out in recent major reports and plans such as the Waitangi Tribunal?s Wei 2575 Hauora report and the New Zealand Cancer Action Plan 2019-2945. Preferred Option The RACP is strongly in favour of mandatory folic acid fortification in ?our. It has been comprehensively shown across the world that mandatory fortification reduces the rate of NTDs, and the previous voluntary regime in Aotearoa New Zealand has failed to have a significant impact, partially due to a failure to achieve the target of 50 per cent forti?cation by volume. We believe that further changes within a voluntary regime are unlikely to achieve the goal of significantly reducing the rate of NTDs, and as such, it is imperative that we move to mandatory fortification. Of the options proposed in the consultation document, we? believe that 3b, the mandatory fortification of all non-organic wheat flour for bread making, is the best approach. This approach avoids safety concerns associated with the overconsumption of folic acid by children, as noted in the consultation document. It also has the advantage of bringing us into step with other countries, such as Australia, who already add folic acid to wheat flour for bread makings. Due to its universal nature, this option would also work to reduce inequity in live births for Maori. Despite this, we also support option 3c, the mandatory fortification of all non-organic what flour for any purposes, as the reduction in NTDs achieved will greatly outweigh any risk associated with the overconsumption of folic acid. Achieving a wide proliferation of folic acid consumption is the most important objective to be achieved, and mandatory fortification at the ?our stage is the best vehicle to accomplish this. This option also retains the benefits of universal fortification, as noted in option 3b. 2 De-Regil M, Pena-Roses P, Fernandez?Gaxiola A C, Rayco-Solon P. Effects and safety of periconceptional folate supplementation for preventing birth defects. [Internet] Cochrane Database Rev. 2010 ?12. Available from: Accessed 11 November 2019 3 Ministry for Primary Industries. Voluntary Folic Acid Fortification Monitoring and Evaluation Report MPI Technical Paper No: 2018/02. [Internet] Wellington: Ministry for Primary Industries; 2018. Available from: report. Accessed 11 November 2019 4 Waitangi Tribunal. Hauora: Report into Stage One of the Health Services and Outcomes Kaupapa Inquiry. Wellington: Waitangi Tribunal; 2019. Available from Accessed 11 November 2019 5 Ministry of Health. New Zealand Cancer Action Plan 2019-2029. [Internet] Wellington: Ministry of Health; 2019. Available from action-plan-2019-2029.pdf. Accessed 11 November 2019 5 Food Standards Australia New Zealand. Folic Acid Fortification. [Internet] Available from: Accessed 11 November 2019 The Royal Australasian College of Physicians 3 Submission to the Ministry for Primary Industries We also note that it is important that mandatory forti?cation applies to gluten-free ?our, due to the significant number of consumers in Aotearoa New Zealand who follow gluten-free diets. While there is a lack of reliable information on the exact prevalence of gluten-free diets in Aotearoa New Zealand, it is estimated that approximately one per cent of children have doctor diagnosed coeliac disease, with five per cent avoiding gluten7. This highlights the need for a comprehensive Aotearoa New Zealand nutrition survey, to truly ascertain what diets are being followed. Despite this, it is clear that a significant proportion of people would not be consuming folic acid if forti?cation did not apply to gluten-free flour. Conclusion The RACP thanks the Ministry for Primary Industries for the opportunity to provide feedback on folic acid fortification. We would also like to note that we support the submission of the Paediatric Society of New Zealand, and we thank them for working with us in the development of our submission. To discuss this submission further, please contact the NZ Policy and Advocacy Unit at policy@racp.org.nz. N?ku noa, na 12% Emma Dr Jeff Brown Aotearoa New Zealand President The Royal Australasian College of Physicians 7 Tanpowpong P, lngham R, Lampshire K. Kirchberg F, Epton J, Crane J, Camargo A Jr. Coeliac disease and gluten avoidance in New Zealand children. [Internet] Arch Dis Child. 12-16. Available from: Accessed 1 1 November 2019 The Royal Australasian College of Physicians 4 Submission to the Ministry for Primary Industries The Royal Australian and New Zealand College of Obstetricians and Gynaecologists 12 November 2019 Food Policy Team Ministry for Primary Industries Food.Policv@mpi.govt.nz Review of folic acid fortification of food Thank you for the opportunity to provide a submission on folic acid fortification of food. About the Royal Australian and New Zealand College of Obstetricians and Gynaecologists The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) is a not-for- profit organisation dedicated to the establishment of high standards of practice in obstetrics and gynaecology and 'excellence in women?s health?. The College trains and accredits doctors throughout Australia and New Zealand in the specialties of obstetrics and gynaecology. The College also supports research into women?s health and advocates for women's healthcare by forging productive relationships with individuals, the community, professional organisations and government. In New Zealand Te Kahui Oranga 6 Nuku supports College activities, taking into account the context of the New Zealand health system and the needs of women in Aotearoa New Zealand. A particular focus of Te Kahui Oranga 6 Nuku, and its sub-committee He Hono wahine, is recognising Maori as tangata whenua and supporting initiatives that will improve equity of outcomes. Feedback on folic acid fortificatia? of food RANZCOG Fellows take a keen professional interest in folic acid fortification. We agree with the Ministry for Primary Industries analysis of the evidence and the objective for reviewing folic acid fortification. Te K?hui Oranga a Nuku strongly supports mandatory fortification of wheat flour used for making bread [Option 3b}. We note that mandatory fortification of bread continues to be a key recommendation of the Perinatal and Maternal Mortality Review Committee included in the Thirteenth Annual Report of the Perinatal and Maternal Mortality Review Committee, September 2019. There is strong and convincing evidence that mandatory fortification of food with folic acid reduces the prevalence of neural tube defects, and the benefits of this outweigh any potential adverse effects. We strongly support mandatory fortification of food to increase folic acid intake for all women. We prefer Option 3b based on the information provided by MPI on the different options, because: 0 of the number of NTDs this strategy could prevent 0 under this option there is less risk of children being exposed to higher levels of folic acid than with Option 3c, and this may also reduce public concern about mandatory fortification 0 data shows that under the voluntary fortification options fewer NTDs are prevented than by mandatory fortification Te Kahui Oranga Nuku PO Box 10611 The Terrace Wellington 6143 New Zealand TEL +64 4 472 4608 EMAIL ranzcog@ranzcog.org.nz WEB While we prefer option 3b we would also support Option BC on the basis that it has the potential to reach more women, particularly those who do not consume much bread. We note that it will be important to monitor the folic acid intake and folate levels of the New Zealand population of all ages and the impact of the introduction of mandatory folic acid fortification, especially in pregnant women. We have completed the submission form template which is attached. If you need further information on any of our comments please contact Catherine Cooper, RANZCOG New Zealand Manager at ccooper@ ra nzcog. org. nz. Nga mihi Dr Celia Devenish Chair, Te Kahui Oranga 6 Nuku RANZCOG Te Kahui Orange 6 Nuku Page 2 Submitter details: Name of submitter Catherine Cooper, RANZCOG Manager New Zealand or contact person: Organisation (if applicable): The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Email: ccooper@ranzcog.org.nz Of?cial information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. if you have specific reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MP1 will consider those reasons when making any assessment for the release of submissions if requested under the Official Information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of child bearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD?affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. [3 Unsure. Please explain why: There is strong evidence that mandatory fortification of food reduces NTDs, more so than either supplementation or voluntary fortification. We are concerned that pro-conception folic acid supplementation use and therefore folic acid intake is a health equity issue in New Zeaiand pro-conception folic acid supplement use is estimated to be lower amongst Miori and Paci?c women, women from low socioeconomic groups, and younger women. Mandatory folic acid forti?cation will help to reduce inequities in folic acid intake, and therefore in NTD rates. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of MTG-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. [3 Disagree. RANZCOG Te Kahui Orange 6 uku Page 3 El Unsure. Please explain why: Increasing the consumption of food containing folic acid is proven to reduce NTDs. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment and based on the assessment and evidence we support mandatory forti?cation. Option 2: Asking industry to enhance voluntary fortification Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment and based on the assessment and evidence we support mandatory forti?cation. We note that Option 2 is not expected to result in the same NTD prevention as mandatory forti?cation. Option 3a: Mandatory fortification of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). RANZCOG Te Kahui Oranga 6 Nuku Page 4 The Australia New Zeaiand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option Ba against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 -- 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY F0 LIC ACID FORTIFICATION OF BREAD AGAINST THE AND LIKELY IMPACT 5? l2] Agree. El Disagree. Unsure. Piease explain why and provide any evidence you may have: We agree with the assessment and based on the assessment and evidence we support mandatory forti?cation - option so. Option 3b: Mandatory forti?cation of non-organic bread?making wheat flour Under option 3b, all no n-orga nic wheat flour for bread-making wouid be fortified with folic acid at the ?our-milling stage. in general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereais other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of foiic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTEFICATION OF MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY El Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: We agree with the assessment of mandatory folic acid forti?cation of bread making wheat four and support this option. We believe it provides the best balance of positive and equitable health impacts (reduced NTDs) with avoiding the risks of young children being exposed to higher levels of folic acid. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option 3c would require the fortification of all non-organic wheat ?our, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. RANZCOG Te Kahui Orange 6 Nuku Page 5 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY ACID OF NON- ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Disagree. CI Unsure. Please expiain why and provide any evidence you may have: We agree with the assessment. Based on the assessment and evidence we support mandatory forti?cation though wheat flour for bread making only - option 3b. While we prefer option 3b, we would also support Option 3c on the basis that it has the potential to reach more women, particularly those who do not consume much breed. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO [3 Agree. [3 Disagree. C3 Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? We note that mandatory fortification requires legislative change and a two year transition period is proposed. We support recommendation that folic acid supplements be funded in the interim: Until bread and ?our fadmcation is implemented, and as an interim measure, folic acid should be provided free. This is not a suitabie long-term measure. Fifty percent of pregnancies are unplanned; therefore, this method is less e?ective than fortification of bread and ?our. 2619 General comments If you have any other general comments or suggestions for the Folic acid fortification: Increasing foiic acid in food discussion paper, please let us know. Nothing further to add. RANZCOG Te Kahui Orange 6 Nuku Page 6 Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming sufficient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zealand's rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: . continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or . introduce mandatory forti?cation of bread, bread-making wheat flour, or all wheat ?our. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public wilt help us understand the possible impacts of the proposals. Once you have completed this form Email to: While we prefer email, you can also post your submission to: Consultation: Folic Acid Forti?cation Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter or contact person: Sonya Marsha? Organisation (if appiicable): Royal New Zealand Plunket Trust Email: Sonyamarshall@plunket.org.nz Official Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial information Act. The problem The number of folic acid-sensitive NTD-atfected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from naturai food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS El Agree. [3 Disagree. Unsure. Please explain why: Plunket supports the problem statement and the evidence provided in the consultation and related folic acid fortification documents. We are committed to ensure all taman'ki under 5, in New Zealand, have the right to the best start in life. NTD affected births can lead to miscarriage. still birth. or live births usually with serious disabilities that have huge impact on the overall health and wellbeing of individuals, their whanau, and wider communities. international research to date has proven that the rate of NTD-atfected pregnancies can be reduced via folic acid forti?cation of staple foods. In 2012, New Zealand began voluntary folic acid forti?cation with the goal that up to 50% of packaged bread would be forti?ed. NTD-a?ected pregnancy rates have not reduced signi?cantly under this scheme. especially when compared to countries where forti?cation is mandatory. Supplementation is only a constructive strategy for those women that plan their pregnancies. Around 53% of New Zeatand pregnancies are unpianned. Supplementation rates during the preconception period are lowest for lower socioeconomic communities. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECT WE OF THE Agree. [3 Disagree. [3 Unsure. Please explain why: Plunket supports increasing the consumption of food containing iotic acid by women of childbearing age to reduce the number of NTD-a?ected pregnancies. According to the Ministry of Health (MOH) survey data in 2014115, most women of childbearing age in New Zealand do not have optimal fol ate ievels for preventing NT D-affected pregnancies. In various countries, systematic reviews of studies completed have identi?ed that mandatory fortification is connected to reductions in prevalence of NT D?affected pregnancies. Our current Piunket Strategy 2016-2021 states our vision, "In the ?rst 1000 days we make the difference of a lifetime?. This was based on the voices of our Plunket peopte, whanau, partners and supporters, guiding our approach with everything we do. Therefore, Plunket understands the impedance of considering consumer choice and increasing equity in heaith outcomes. We encourage the Panel to ensure it is clear about the extent of ?consideration? it will take with regards to consumer choice and equity of health and outcomes. The Panel need to ensure Te Tiriti Waitangi obligations are met, thus all iwi and whanau Maori rights to participate in decision-making about their health are upheld. The process for decision making must include a partnership approach with Maori and supportconsultation throughout all phases of this process. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE ?5 Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: Plunket agrees with the assessment of Option 1. The voluntary forti?cation scheme is unlikely to achieve the objectives sought from this review. Voluntary folic acid forti?cation of staple foods has been permitted in NZ since 1996. The current goal is for industries to fortify up to 50% of their packaged sliced bread at a ievel of 200m per 1009 of bread. Between 2016 and 2017, forti?cation of bread increased from 32% to 38% and has not changed much since. Even if 50% forti?cation is reached this option will still have little impact around reducing the rate of NTD?affected pregnancies. Comparing NZs current NTD-affected pregnancies prevalence rate to other countries, it is stiff high. The various negative impacts NTD-affected pregnancies have on individuals, whanau, and society is important for not only the industry to understand, but also the public. According to MPI this option is not equitable compared to the other proposed options. There would be continued disparities in NTD-affected pregnancy rates for Maori and teenage mothers. Plunket agrees with this assessment. While of all the options, the status quo ensures signi?cant consumer choice is maintained, in weighing up the evidence presented, we believe it will not solve the problem as outlined by MPI. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have: The Technical Paper by stated that it is uniikely enhanced voluntary forti?cation would be achieved. Plunket agrees with this assessment. Piunket views this option as simply increasing the target of the current voluntary scheme, which we know has not yet achieved its target. There is no evidence that simply increasing the target will change the actions of industry. Given Plunket?s interest in the health and wellbeing of all whanau, we do not believe any assurance has been given in this option that it will directly reduce the occurrence of NTD-affected pregnancies. Adherence to Te Trriti Waitangi is an obligation for both and Plunket, achieving equity of health outcomes is a primary focus. This option does not support a strong enough response to reduce the prevalence of NTD-atfected pregnancies. Given that this is a voluntary approach, it is uncertain when 80% forti?cation will be reached. The proposed transition period will take years to implement, delaying the achievement of equitable outcomes for the population. Option 3a: Mandatory forti?cation of non-organic bread Option 33 would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: Plunket supports the assessment of this option. Plunket encourages to consider that more research is required to ascertain any risk related to over consumption of folic acid. Mandatory forti?cation of folic acid has a positive effect on improving equity. Mandatory forti?cation will support the reduction in NTD rates for Maori women and younger mothers who are more likely to have lower tevels of folic acid. While Plunket doesn?t disagree with imptem enting this option, we believe that focusing on the source, ?our mills, as the point of forti?cation. would support the process to be more streamlined, and easier to mandate resulting in increased and consistent implementation. Option 3b: Mandatory forti?cation of nonnorganic bread-making wheat flour Under option 3b, all non-organic wheat ?our for bread?making would be forti?ed with folic acid at the flour-milling stage. in general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness. equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FO LIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. [3 Disagree. l3 Unsure. Please explain why and provide any evidence you may have: Plunket supports the assessment of this option. and believes it is the most appropriate option for implementation; It supports mandatory forti?cation Supports positive health outcomes ls cost effective Supports equity 0n the available evidence. including overseas experience, the proposed level of forti?cation of bread does not pose a risk to public health and safety. Mandatory forti?cation of folic acid has a positive effect on improving equity. Mandatory forti?cation will support the reduction in NTD rates for Maori women and younger mothers who are more likely to have lower levels of folic acid. Having the ?our mills as the point of forti?cation allows the process to be more streamlined, and easier to mandate. Plunket encourages MPI to consider that more research is required to ascertain any risk related to over consumption of folic acid. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option So would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zeaiand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity. consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. [It Disagree. El Unsure. Please explain why and provide any evidence you may have: PIunket agrees with the assessment of this option. Plunket does not support the implementation of this option as 36% of chitdren 5 - 8 years old have the potential of consuming ciose to their upper limit. Research into the setting of this upper iimit is required for this poputation group, and what negative effects may come with over consumption before this option can be fully impiemented and supported safely. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO tit Agree. Ct Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? As Plunket would not be impacted by any outcome of this consultation, we have no comment to make specifically on impiementation. We are, however, interested in any opportunities to support increased folic acid consumption through health promotion strategies. General comments If you have any other general comments or suggestions for the Folic acid forti?cation: increasing folic acid availability in food discussion paper, please let us know. Ptunket supports option 3b for the reasons above. especially as the review identi?es this would have the most positive health impact for tamariki. Ptunket is one of the largest national organisations to deliver health and support services to tamariki and whanau. More than 250,000 tamariki under the age of ?ve rely on Plunket for their Well Childi'l'amariki Ora (WCTO) health checks, and health education (around safety checks, iniury prevention, nutrition, water safety, oral health checks and general advice). Ptunket also delivers a variety of community based health and support services, including in some locations Hapu Mama I Pregnancy and Parenting courses. Plunket has the ability to support and engage with whanau from pare-conception to 5 years. Through our range of services, parents also come back to us for support with subsequent children. We are wet! placed to support health promotion to these parents, focusing on a more equitable future for NZ tamarikimhtmau and society. Scott Metcalfe-Springford (was Scott Metcalfe) 13 November 2019 Submission to the Ministry for Primary Industries: Review of folic acid fortification of food Thank you for the opportunity to submit late on the Review of feiic acid fortification uij (9ng I am a specialist in public health medicine, employed as a deputy medical director and chief advisor population medicine for a Crown health funding agency, and chair the Policy committee of the New Zealand College of Public Health Medicine and am on the Specialist Council of the New Zealand Medical Association (NZMA). I write in a private capacity. I support MPl's proposal to introduce mandatory fortification of all non-organic wheat flour for bread? making purposes (Option Eib),1 as a sensible, feasible, highly cost?effective, safe, and equitable approach to reducing NTDs in NZ. Current approaches to improving folic acid intake, including supplementation for planned pregnancies and voluntary fortification by large bread makers are insufficient to address this health need. The continuing high incidence of neural tube defect (NTD)~affected pregnancies in New Zealand is, in the face of inadequate dietary folic acid consumption in women of child?bearing age despite technological feasibility (effective food forti?cation), and in light of inability in previous consultation rounds to secure sufficient societal and policy impetus to regulate, remains a failing in New Zealand public policy (as a society, not the Ministry might I add). The introduction of mandatory folic acid fortification in NZ has great potential to positively impact on the number of NTDs. Benefits will extend beyond reducing those health losses and costs counted in the CBA undertaken bv the Sanere Research Group: they include reductions in spontaneous miscarriages and the need for medical terminations, and reducing inequalities between Maori and non-Maori. I also agree with the stances of the and the NZMA (at acid submission finalpdf and data/assets/pdf Fortificationpdi respectively). Thank you for the opportunity for the to submit on the Review of folic acid fortification of food, and I hope my feedback is helpful. I am more than happy to provide further clari?cation as needed. Dr Scott Springford?Metcalfe, 1. Ministry for Primary Industries. Folic acid fortification: increasing folic acid availability in food. New Zealand Food Safety Discussion Paper no: 2019/08. Wellington: MPI, 2019. discussion-document) Submission Form Introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bi?da. New Zeaiand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: - continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread - ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, of; introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level. has any harmful health effects. All options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will heip us understand the possible impacts of the proposals. Once you have completed this form Emait to: While we prefer email. you can also post your submission to: Consultation: Fotic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. ., .. Submitter details: Name of submitter Scott Metcalfe-Springford (was Scott Metcalfe) or contact person: Organisation (if applicable): Email: rated) Of?cial Information Act 1982 All submissions are subject to the Of?cial information Act and can be released (along with personal details of the submitter) under the Act. if you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial information Act. The problem The number of folic acid-sensitive NTD-affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception- Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. Disagree. l3 Unsure. Please explain why: NTDs, such as spina bi?da or anencephaly, can lead to miscarriage, stillbirth and major disabilities. New Zealand experiences a significant burden of using global burden of disease data,2 note that in New Zealand about 1064 disability-adjusted life years are lost yearly to NTDs. NTDs place an enormous emotional stress and a huge ?nancial burden on familieslwhanau and communities. In 2019, the average lifetime cost of an NTD-affected live-birth, compared with that of the general population, was estimated at $938,000, (which includes costs such as that of caregivers, health are educational support and lost productivity).3 N'l'Ds affect Maori communities disproportionately, with NTD-affected live births 2000 to 2015 was live births among maori women, compared with 281110.000 live births among NZ European women.? NTD-affected births are a large stress on the child?s iwi and hapu. It will be helpful for MPI to include explicth equity in its problem statements. The objective of the review The objective of this review is to increase the consumption of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE El Agree. 13 Disagree. Unsure. Please explain why: Fortification is a low-cost, wide-reaching public health intervention with the potential to reach even the most vulnerable populations when implemented reasonably. As acknowledged in the MPI discussion paper,1 fortifying a staple food can be an ef?cient and equitable way to ensure everyone bene?ts regardless of socioeconomic status, age, gender or (health) literacy. 2. Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2017 (GBD 2017) Results. Seattle: Institute for Health Metrics and Evaluation University of Washington 2018. .. code 81.2.1.1 neural tube defects New Zealand. calculated 1063.9 annual mean DALYs 2013-2017; 17935.5 DALYs 2009-2017 3. Moore D. Young (Sapere Research Group). Folic acid forti?cation: both society and individuals bene?t. New Zealand Food Safety Technical Paper No: 2019/05. Wellington: MPI. 2019. 4. Of?ce of the Prime Minister's Chief Science Advisor. Royal Society of New Zealand Te Aparangi. The hea forti?cation of food. Wellington: OPMCSA. 2018Ith benefits and risks of folic acid 1 IL: I I 2 li-Ia-Iihanlkua- .kl I 'Consumer choice' vs. the rights of people and their faLilieslwhanau born with or unable to be born because of NTDs i am dismayed that previous attempts to introduce folic acid forti?cation have proved unsuccessful, due in part to concerns about the limitations being placed on consumer choice. Whilst I recognise that consumer choice and industry impact are criteria that are important to some sections of society, I deem these considerations should always be secondary to potential health and equity benefits. The signi?cant bene?ts to babies, mothers and society that can be gained through folate fortification. especially in addressing the disproportionate burden of NTDs amongst Maori, outweigh the advantages of consumer choice and indushy convenience. For those who argue autonomy and wanting the right to eat baked goods not forti?ed with folic acid, I note that children born with NTDs, and the many more families/whanau of children who don?t survive to be born with NTDs, in a folate- depleted food and public policy environment, have little choice to even lose in the ?rst place. i cannot agree with arguments pitched as the rights of many over the rights of a few (in Appendix 3 of the MPI discussion paper1 Many people and families are affected by NTDs. I estimate New Zealand has lost nearly 18,000 disability-adjusted life years from NTDs since mm,2 which is appreciable. New Zealand already accepts the rights of fewer people very badly affected overriding the lesser impacts on many peopte's 'autoncmy?, eg. the fluoridation of community water supplies,5 or very recently with firearm controt measures following the terror attacks in Ghristchurch.6 Modelling the costs and bene?ts I consider the Sapere Research Group's Cost-Benefit Analysis assumptions are much too conservative. As indicated in the MPI discussion paper. the CBA measured only the bene?ts for NTD-affected live births and stillbirths, and not NTD-affected terminations (for what Sapere considered both excessive difficulties quantifying the ?nancial impact of terminations and ethical challenges). 3 consider the CBA should have considered all NTD-affected live births and foetal deaths, including not only still births but also NTD-induced terminations? The NIH discussion paper1 (p.57) provides a relatively high rate for induced terminations for NTDs an average of 29 per year (behueen 2011 and 2015}, which is signi?cant in addition to the yearly averages of 26 NTD-affected live births and 9 NED-affected stitlbirths. While the inclusion of induced terminations is potentially contentious, given the high number of average yearly terminations, I submit that NTD-associated terminations should at a minimum have been included in the sensitivity analysis. The termination number is high and provides even more incentive to prevent NTD s. Odier factors mentioned in the Sapere report, but not measured in the CBA and which nevertheless should have been counted. are: Wider impacts on family and whanau of caring etc. for children surviving with NTDs. These impacts are considerable. (Wider impacts are captured in frameworks such as PHARMAC's and Treasury?s Wellbeing Framewo?.) Health impacts on parents and family from foetal deaths and from medical terminations forced by unsalvageable N'st in pregnancy. Possible reductions in the severity of remaining NTDs (aside from decreased incidence). Decreasing rates of folate de?ciency in adults and children across the population, with associated health effects. Even more importantly, the Sapere CBA also excludes spontaneous miscarriages likely amenable to dietary folate. The above 64 annual Nib-associated live counts are small when compared with possible spontaneous miscarriages likely amenable to dietary folate. estimate there are 15 to 21 times as many NTD-affected cases of spontaneous miscarriages each year 5. New Zealand College of Pubiic Health Medicine. Policy Statement on Water Ftuoridation. Wellington: 2013. 6. Public Health Association of New Zealand. New Zealand College of Public Health Medicine. Joint submission on Arms (Prohibited Firearms Magazines. and Parts). Amendment Bill. Welington: PHANZ. 2019. as there are NTD-affected live births or foetal deaths (including induced terminations),3 9 1" a huge amount. Spontaneous miscarriages devastate expecting mothers, parents and whanau, alongside cost extra to the health sector, and should have also been included in the CBA. Other factors not mentioned in the Sapere report, which should have been counted, are the other health bene?ts from better dietary folate intake catalogued in the 2018 joint report by the Of?ce of the Prime Minister's Chief Science Advisor and the Royal Society of New Zealand Te Aparangi,4 where dietary folic acid reduces or potentially reduces the risks of: - birth defects such as orofacial {liprpalate} clefts, heart defects, urinary tract defects, Down Adverse pregnancy and birth outcomes such as pre?eclarnpsia, placental detachment from the uterine wall, spontaneous abortion, pre-term delivery, and low birth weight?:12 0 Diseases of age eg. strokes, cardiovascular diseases, speci?c cancers, osteoporosis. and cognitive dysfunction.?i Given the exclusion of NTD-affected spontaneous miscarriages and later medical terminations with wider impacts likely amenable to dietary folate, and other factors, I consider the Sapere CBA considerably underestimates the population bene?ts, and undercounts the cost-effectiveness of the various folate fortification proposals. Discounting support the Sapere use of the 3.5% discount rate13 in the CBA. I support an investment approach to health, which takes a long-tom: view and accounts for full long-term costs.14 The considers that discounting of non-budgetary costs and bene?ts over time should use a social rate of time preference with a long-tenn rate of return that is riskless risk-free) rather than risk-adjusted, and which considers intergenerational impacts.13 This means using a lower discount rate than was used and promoted years ago. ?4 As an example, cost-effectiveness analyses for pharmaceuticals and medical devices discount uses a riskless rate of return, set by PHARMAC In 2007 at 3.5% (based on the then 5-year average real risk ?free long -term government bond rate). PHARMAC says that it does not incorporate risk into the discount rate for cost- effectiveness analyses, as discounting represents individuals? time preferences and any risk (or future uncertainty) is taken into account elsewhere In modelling ?3 Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. I calculate annually 970 to 1380 spontaneous miscarriages are excess when comparing total folate levels in pregnant women (calculated relative risk 1.08 for history of folate intake preconception for quintiles with folate <800 ug/day vs. quintile with fo late >800 ugfd ay (C15) in the Nurses? Health Study-ll (Gaskins et al. Gml. 2014 Table 2. hence with 1.3% risk of spontaneous miscarriages due to folate de?ciency 4- all pregnancies. applied to NZ vital statistics hence imputed pregnancy counts (calculated algebraically from: 58020 live births. 288 still births. 13232 terminations (ESE data 2019: 15?20% rates of spontaneous pregnancies?. Calculations available on request. 9. Gaskins Rich -Edwards Jw Hauser R. et al. Maternal prepregnancy folate intake and risk of spontaneous abortion and stillbirth. Obstet Gynecol 2014:12423-31 10 Note the 15.21 multiplication factor for spontaneous miscarriages is even greater than the 13-13 calculated' In the mm which mistakenly omitted the 13282 terminations, affecting imputed pregnancy counts. The 15-21 factor supersedes the 13-18. 11. Wang Y. Zhao N. Qiu J. et al. Folic acid supplementation and dietary folate intake. and risk of preedampsia. Eur Clin Nu tr. 12. Fekete K. Berti C, Trovato et al. Effect of folate intake on health outcomes In pregnancy: a systematic review and meta- -analysis on birth weight. placental weight and length of gestation. NutrJ. 2012; 11 :.13. New Zealand College of Public Health Media?ne. Public Health as an Investment Policy Statement. Wellington: 2019. 11 .n2 m. or .n media 1261 1 19 10 as an investment statemen 14. Metcalfe S. Gunasekara S. Baddock K. Clarke Tune for healthy investment. Wellington: New Zealand Medical Association. 2017. . . . 9 01? El Disagree. El Unsure. Please explain why and provide any evidence you may have: I agree with the assessment that continuing the status one would do little to reduce rates of affected pregnancies, and that this approach would not: help achieve health equity. Despite a 50% target. after six years of working to the voluntary code, in 2017 the volume of bread being forti?ed had increased to only 38%, signalling industry inability to implement such a target. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: I agree with the assessment of option 2 and note that while this approach has the potential to prevent a number of future NTDs and result in substantial taxpayer savings, the approach relies completely on the voluntary participation of large plant bakers. This won't achieve the objective set by this review. Option 33: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non- organic bread products, and include bread made from cereals other than wheat (eg. corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods {such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 - 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND LIKELY Agree. El Disagree, El Unsure. Please explain why and provide any evidence you may have: I agree with the assessment of Option 3a and note that this option would have signi?cant positive health impacts and would be more effective than a voluntary forti?cation approach. I also note that this approach does not pose a public health risk to non-target groups such as children. However, the compliance and monitoring costs in operationalising this approach would be high due to the high number of bakeries that would be affected and foresee that this option would be dif?cult to monitor and may not be the most cost-effective approach. Therefore, I do not support this option to achieve the review's objective. Option 31): Mandatory forti?cation of non-organic bread-making wheat ?our Under option 3b, all non-organic wheat ?our for breadmaking would be forti?ed with folic acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folio acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Unsure. Please explain why and provide any evidence you may have: I agree that Option 3b would have better health bene?ts than Options 1, 2 and 3a, although it wril not prevent as many NTDs as Option 3c. We note that a smaii percentage of children may exceed the upper limit for folio acid intake at this ievel, but at a population level this proportion is considered acceptable. I note that Option 3b provides the greatest value for money compared with Options 1, 2 and 33. Compliance and monitoring costs will not be as signi?cant as Option 3a due to the number of mills affected being small. Like Options 3a and 3c, Option 3b will work to achieve health equity in NTD outcomes between maori and non-Maori. This is because mandatory forti?cation removes the element of chance inherent in a voluntary approach and is not reliant on the health literacy of consumers. Option 3b also provides a high level of consumer certainty that all non-organic wheat bread is forti?ed. Additionally, Option 3b is likely to result in greater certainty of consistently achieving the target folio acid range, given the small number of mitts, compared with the large number of bakeries (as per Option 3a). Finally, it is likely that of all the mandatory options, Option 3b offers the greatest choice, as consumers can still choose between organic or non-wheat breads. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option So would require the forti?cation of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Austraiia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7.. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIO ACID FORTIFICATION OF WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. Cl Disagree. El Unsure. Please explain why and provide any evidence you may have: agree with the assessment of Option 3c. Option 3c expands on the range of food products that would contain forti?ed flour over option 3b, and I note that there may be some potentiat safety risks associated with this. The Institute of Medicine set the Tolerabte Upper intake Level for folic acid (from suppiementation and forti?cation) at 1000pg (1 mg) per day, for adults.? The consequences of exceeding me upper limit for children are unknown as the upper limit was only set for adults, and then adjusted for body weight.4 As the level of forti?cation increases, the likelihood of people exceeding the upper limit also increases.3 There is the risk that forti?cation of all non-organic wheat flour (as per Option 3c) may resutt in a proportion of children exceeding this upper limit. I note MPi?s modelling estimate that up to 36% of 5 to 8-year olds could consume too much folic acid under this approach, and for this reason cannot provide unquali?ed support for Option 3c. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 - 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO 3 Agree. Disagree. El Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? i do not support the implementation of the voiuntary approaches (Options 1 and 2) for the reasons provided above. I support the impiementation of the mandatory approaches (options 3a, 3b and So). I agree with the proposed ptan for monitoring folic acid levels and health impacts of forti?cation (in conjunction with the Ministry of Health) as well as the plan for dealing with non-compliance. General comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folio acid availability in food discussion paper, please let us know. ldo not consider the voluntary approaches (Options 1 and 2) would achieve the review's objective or have meaningful nor enough population health and health equity impacts. For the reasons provided above, I support Option 3b as the best approach to achieve the review's objective, reduce suf?ciently the number of NTDs in NZ and work to safely achieve health equity in NTD outcomes between Maori and non-Maori. Submission Form Introduction Folic acid is an essential vitamin important for the healthy deveiopment of babies early in pregnancy. There is overwhelming evidence that consuming suf?cient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as epina bi?da. New Zealand?s rate of NTDs is higher than it could be, and Maori women have higher rates of affected live births than other groups. The ?nancial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. MPI recognises the importance of this issue and is seeking feedback on whether the government should: 6 continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread. or . introduce mandatory forti?cation of bread, bread-making wheat ?our, or all wheat flour. There is no consistent evidence that folic acid, when forti?ed in food at the recommended level, has any harmful health effects. Ail options would exclude organic products. We are seeking your feedback on these options. Hearing the views of the public will help us understand the possible impacts of the proposals. Once you have completed this form Email t0: Wanna While we prefer email, you can also post your submiSsion to: Consultation: Folic Acid Forti?cation Ministry for Primary Industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: Name of submitter Catherine Thomas and Christine Quested or contact person: Organisation (if applicable): Southern District Health Board (SDHB) Email: Official Information Act 1982 All submissions are subject to the Of?cial Information Act and can be released (along with personal details of the submitter) under the Act. If you have speci?c reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI will consider those reasons when making any assessment for the release of submissions if requested under the Of?cial information Act. The problem The number of folic acid-sensitive NTD~affected pregnancies in New Zealand could be reduced it the blood folate levels of women of childbearing age was improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folio acid tablets during the critical period of at ieast one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with folic acid. This is not enough, however, to suf?ciently reduce the risk of NTD-affected pregnancies across the New Zealand population. 1. DO YOU AGREE WITH THE PROBLEM AS Agree. El Disagree. Cl Unsure. Please explain why: We agree with the problem as stated; many New Zealand women (of child-bearing age) are not receiving the desired folate levels. Making folic acid forti?cation mandatory in a product (eg. all bread-making flour) would ensure a larger population reach, and reduce NTD prevalence {Australia has taken this approach). Maintaining the status quo of voluntary forti?cation of food allows consumers to choose whether to eat those foods, and the producer can choose to adopt adding folic acid to their products witl risk leaving certain groups of child-bearing age women vulnerable. The objective of the review The objective of this revievr is to increase the consumption of food containing folio acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. El Unsure. Please explain why: Southern DHB (SDHB) agrees with the objective of this review as ensuring that New Zealanders receive more folic acid ?naturally? through food will reduce NTD prevalence. increasing folic acid at the population level will increase equity of health outcomes (especiaily in the Maori population), while also minimising impacts on industry. Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. MPI has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUO AGAINST THE Agree. l3 Disagree. El Unsure. Please explain why and provide any evidence you may have: SDHB agrees with the assessment of the status quo, however we do not agree that fortification of folic acid in food should be voluntary as it is unlikely to reach population groups with the highest rates of unplanned pregnancies and relies on individual consumer knowledge of the bene?ts of folic acid. Knowledge and awareness of folic acid forti?cation of bread and its link to reduced NTDs is far from universal. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would invoive asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 - 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. El [3 Unsure. Please explain why and provide any evidence you may have: SDHB agrees with the assessment of the enhanced voluntary forti?cation, however we do not agree that forti?cation of folic acid in food should be voluntary, even if it is enhanced, as it is uniikeiy to reach popuiation groups with the highest rates of unplanned pregnancies and relies on individuai consumer knowledge of the bene?ts of folic acid. Knowledge and awareness of folic acid forti?cation of bread and its link to reduced NTDs is far from universal. Option 3a: Mandatory forti?cation of non-organic bread Option 33 would see bread forti?ed with foiic acid at the bread-making stage. it would apply to all non- organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND Agree. El Disagree. El Unsure. Please expiain why and provide any evidence you may have: SDHB agrees with the assessment of mandatory folic acid forti?cation of bread, and believes that mandatory fortification will result in the greatest reduction of NTDs and associated costs and impacts health care, emotional, whanau and ?nancial). However, SDHB doesn?t support option 3a because the high forti?cation, compliance and monitoring costs may mean it is less iikely to be impiemented effectiveiy. SDHB supports option 3b (mandatory forti?cation of non-organic bread- maidng wheat flout). Option 3b: Mandatory forti?cation of nonworganic bread-making wheat ?our Under option 3b, alt non-organic Wheat flour for bread-making would be forti?ed with folic acid at the ?our-milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the flour. Cereais other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as nee). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereais). MPI has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 6. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY a Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: SDHB agrees with the assessment of mandatory folic acid forti?cation of bread-making wheat flour. and believes that mandatory forti?cation will result in a signi?cant reduction of NTDs. less potential risk of folate over-consumption in children, lower associated costs and more effective impacts. It will also ensure that ail New Zealanders, including the priority population of women of child-bearing age, have equal opportunity to increase their blood folate levels. It would be bene?cial to include gluten-free bread ?ours that are made in New Zealand, to reach those individuais with ooeliac disease or gluten intolerances. The 2-year transition period seems crucial and ensures ?our miliers won?t be penalised for adjusting to new requirements. Option 3c: Mandatory forti?cation of all non-organic wheat ?our Option So would require the forti?cation of all non-organic wheat ?our, whether miiled in New Zealand or imported from overseas. The Australia New Zeatand Food Standards Code Would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 30 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY l2! Agree. El Disagree. El Unsure. Please explain why and provide any evidence you may have: SDHB agrees with the assessment of mandatory folic acid forti?cation of non~organic wheat-flour as the DHB holds the belief that mandatory forti?cation will result in the greatest reduction of NTDs and associated costs. However we do not support option 30 as the assessment highlights that there are potentially greater health concerns for young children and less consumer choice due to foiic acid being in all wheat flour. Hence. SDHB supports option 3b. Implementation MPI provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. El Disagree. Cl Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? As stated in the proposed guide for mandatory folic acid forti?cation, an educational component would be bene?cial for millers to ensure the affected sector understands requirements. With the introduction of mandatory folic acid forti?cation, SDHB agrees with a graduated approach to enforcement to assist the industry to achieve cornptianoe with new standards. With more experience, technical challenges, such as not meeting the agreed folate levels, wilt lessen. SDHB agrees with the inclusion of a warning scheme before infringement fees but suggests framing it as a warning period for non-compiiance. For exempts, if it is found at the 6 compliance monitoring that a business hasn?t met the correct level of folate in their food product non-organic bread-making wheat flour) they would receive a formal warning and would be required to participate in a foliow-up monitoring in an unspeci?ed time in the next 6 9 months. if after this warning period a business is still not compliant then infringement fees can be issued. The 2-year transition period will help businesses settle in to the new way of working. Enforcement measures also need to include manufacturers changing ingredient lists to take folate into account. General comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. The prevalence of NTDs, which are a serious health concern in New Zealand, could be signi?cantly reduced by introducing mandatory forti?cation of folio acid in food products due to more folic acid being consumed. SDHB recommends introducing mandatory folic acid forti?cation of bread-making wheat flour (option 311). This approach has been implemented in Australia and as a consequence the prevalence rate of NTD has reduced below New Zealand prevalence rates (using voluntary forti?cation). SDHB believes making it mandatory to have folic acid in bread-making wheat ?our is the best option for the following reasons: 0 Lower associated costs. 0 It doesn't have the potential health risk of children receiving too much folic acid, which is associated with option So. There is still an element of consumer choice with bread-making wheat flour compared to all wheat flour, as other baking items such as biscuits, cakes, muf?ns (etc) will not use flour containing folate. SDHB does not support continued voluntary forti?cation. as it is unlikely to reach population groups with the highest rates of unplanned pregnancies, and relies on individual consumer knowledge of the bene?ts of folic acid and the types of food product they should choose to ensure they get enough folic acid. Ensuring gluten-free bread?making flour is also forti?ed with folic acid would be bene?cial from a whole population approach, with a projected 60,000 - 70,090 New Zealanders having diagnosed coeliac disease (1 in 70), and additional people suffering from gluten intoleranoes. SDHB encourages MPI to review the adopted policy after a three-year period, and then consider forti?cation of all ?our, especially if NTD rates haven't declined signi?cantly with mandatory forti?cation of bread?making ?our. PLENTY HEALTH DISTRICT HEALTH BOARD A A A 3' i Online Submission Form introduction Folic acid is an essential vitamin important for the healthy development of babies early in pregnancy. Theft; is overwhelming evidence that consuming sufficient folic acid before conception and during early pregnancy can prevent many cases of neural tube defects (NTD) such as spina bifida. New Zealand?s rate of NTDs is higher than it couid be, and Maori women have higher rates of affected live births than other groups. The financial, social, and emotional impact from these birth defects can be signi?cant for many families, whanau, and communities across New Zealand. recognises the importance of this issue and is seeking feedback on whether the government should: continue with the current voluntary approach of fortifying up to 50% of packaged sliced bread 0 ask industry to enhance the voluntary approach to fortify 80% of packaged sliced bread, or 0 introduce mandatory fortification of bread, bread-making wheat flour, or all wheat flour. There is no consistent evidence that foiic acid, when forti?ed in food at the recommended level, has any harmfui health effects. All options would exciude organic products. We are seeking your feedback on these options. Hearing the views of the public will heip us understand the possible impacts of the proposals. Once you have completed this form Email to: FMPolingingovtnz While we prefer email, you can also post your submission to: Consultation: Folic Acid Fortification Ministry for Primary industries PO Box 2526 Wellington 6104 Submissions must be received no later than 5:00pm on 12 November 2019. Submitter details: . Jasmin Jackson Name of submitter or contact personOra Public Health, on behalf of Bay of Plenty District Health Board Organisation (if applicable): and Lakes District Health Board. Email: enguirethoiteora.govt.nz Official information Act 1982 All submissions are subject to the Official information Act and can be released (along with personal details of the submitter) under the Act. if you have specific reasons for wanting to have your submission or personal details withheld, please set out your reasons in the submission. MPI consider those reasons when making any assessment for the release of submissions if requested under the Of?cial Information Act. The problem The number of folic acid?sensitive NTD?affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age were improved. Most women of childbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levels for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folic acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily fortified with folic acid. This is not enough, however, to sufficiently reduce the risk of NTD?affected pregnancies across the New Zealand population. 'k 1. DO YOU AGREE WITH THE PROBLEM AS Agree. Disagree. [3 Unsure. Please explain why: The Bay of Plenty and Lakes District Health Boards (the DHle agree with the problem as stated in the discussion paper. The DHBs consider the described inequity for wahine Mz?iori and women under 25 years a key component of the rationale for mandatory folate forti?cation. The objective of the review The objective of this review is to increase the of food containing folic acid by women of childbearing age, thereby reducing the number of NTD-affected pregnancies, while considering consumer choice, increasing equity of health outcomes, and minimising impacts on industry. 2. DO YOU AGREE WITH THE OBJECTIVE OF THE Agree. El Disagree. El Unsure. Please explain why: The Bay of Plenty and Lakes District Health Boards (the DHBs) support public health interventions that reduce disparities in health outcomes for those most affected. Health impact (including potential for harm), and equity, are the top priorities for the DHBs, and these have been accounted for in the assessment criteria. This is a public health initiative; these work most effectiveiy by making consumer decision making simple. The DHBs do not support weighting 'consomer choice' as of equal importance with the other considerations. The lack of health literacy in the population means that the general population is not well educated on the topic of fortification (Satheriy et al, 2008). in New Zealand 56.2% of the adult population has poor health literacy skiils (54% for non-Maori males and females, and 74% for Maori males and 80% for Maori females} (Ministry of Health, 2010). Plus, as stated, over half of all pregnancies in New Zealand are unplanned. The activities used to determine an individual's health literacy include activities involving reading and understanding food labels. These results indicate the population is likely to have difficuity in understanding compiicated notritional information. Additionally, price and trusted branding are the main driver of consumer choice (Walton et al, 2009). Fortification status is not a key factor for most consumers when making decisions around which product to (Food Standards Australia New Zealand, 2010). References: Consumer awareness, attitudes and behaviours to fortified foods (2010}. Food Standards Australia New Zealand; Melbourne. Ministry of Health. 2010. Korero marama: Health literacy and Maori Results from the 2006 adult literacy and life skills survey. Wellington: Ministry of Heaith. Satherley, P., Laws, E, 8: Sok, S. (2008). The aduit literacy and life skills (ALL) survey: Overview and internationai comparisons. Wellington, New Zealand: Ministry of Education. Retrieved from datala ssetslodi filer'DO 10/1 94 QSIOverview-and-lnternational? Com risons. Walton, M, Signal Thompson 6. (2009). Household economic resources as a determinant of childhood nutrition: policy responses for New Zeala nd. Social Policy Journal of New Zealand, 36, 194-207. Option 1: Maintaining the status quo Option 1 would invoive continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread. by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 21 in the discussion paper. 3.. DO YOU AGREE WITH THE ASSESSMENT OF THE STATUS QUD AGAINST THE Agree. Cl Disagree. Cl Unsure. Please explain why and provide any evidence you may have: The Bay of Plenty and Lakes District Heaith Boards agree with the assessment of the status quo against the criteria. Both DHBs agree that this is NOT the preferred option, as with the status quo, wahine Maori and Pasifika, as well as teenage mothers, experience significantly higher rates of NTDs than the general population; carrying on with the status quo would maintain existing inequities in health. Option 2: Asking industry to enhance voluntary forti?cation Option 2 wouid involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being fortified under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for heaith impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion paper. 4. DO YOU AGREE WITH THE ASSESSMENT OF THE ENHANCED VOLUNTARY FORTIFICATION OPTION AGAINST THE CRITERIA AND LIKELY Agree. [3 Disagree. Cl Unsure. Please explain why and provide any evidence you may have: The Bay of Plenty and Lakes District Health Boards (the DHBs) agree with the assessment of Option 2. The DHBs do not support this option. It would be difficult for industry to reach agreement on the level of forti?cation is required, and there is no guarantee, even could agreement be reached, that the agreed level of fortification would be suf?cient to prevent NTDs. This option could result in an increase in NTDs if the industry agreed level of forti?cation was below an effective level of prevention. This option would still require education around consumer choice. This could result in an increased levei of inequity, especially if additional costs of fortification are passed on to the consumer. Less educated women and those on lower incomes would have less access to forti?ed products. This option involves a longer time frame for implementation which in turn means that any puhiic health benefits would be delayed; more preventable NT 05 will occur than with mandatory forti?cation. Option 3a: Mandatory fortification of non-organic bread Option 33 wouid see bread fortified with foiic acid at the bread-making stage. It would appiy to all non-organic bread products, and inciude bread made from cereals other than wheat leg. com and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of foiic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 33 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF BREAD AGAINST THE CRITERIA AND Lll?iEL'l?r El Agree. El Disagree. El Unsure. Please eXplain why and provide any evidence you may have: The Bay of Plenty and Lakes District Health Boards agree with the assessment of mandatory folic acid fortification. Option 3a would be the favoured option were it not for its net positive cost and difficulty of implementation. There are many more bakers than there are millers. We add that good regulatory monitoring and accountability for under-fortified products is important for ensuring we achieve the desired outcome of fortification (Luthringer et al, 2015). References: Luthringer, C. L, Rowe, A., Vossenaar, M, Garrett, G. S. (2015). Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices. Global i-ieaith: Science and Practice, 446?461. doi: 10.9745/ghspaasoo171 Option 3b: Mandatory forti?cation of non-organic bread-making wheat ?our Under option all non?organic wheat flour for bread-making wouid be forti?ed with folic acid at the ?our? milling stage. In general, folic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the fiour. Cereals other than wheat that are processed into flour for bread-making purposes would not be required to be fortified with folic acid (such as rice). Flour used for purposes other than bread making would not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voluntary fortification of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 34 in the discussion paper. 5. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOUC ACID FORTIFICATION OF BREAD-MAKING WHEAT FLOUR AGAINST THE AND IMPACT 5? Agree. 13 Disagree. Cl Unsure. Please expiain why and provide any evidence you may have: The Bay of Plenty and Lakes District Heaith Boards agree with the assessment of option 3b and supports this as its preferred approach to address the problem of NTDs. With this option there be a range of folic acid free products. An increase in equity for Maori and teenage mothers is a key bene?t of this approach. Option 3c: Mandatory forti?cation of all non-organic wheat flour Option 3c would require the fortification of all non-organic wheat flour, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other specified foods (such as breakfast cereals). MPI has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 - 39 in the discussion paper. 7. DO YOU AGREE WITH THE ASSESSMENT OF MANDATORY FOLIC ACID FORTIFICATION OF NON-ORGANIC WHEAT FLOUR AGAINST THE CRITERIA AND LIKELY Agree. El Disagree. Ci Unsure. Please explain why and provide any evidence you may have: The Bay of Plenty and Lakes District Health Boards (the DHBs) support the assessment of Option 3c. The DHBS do not support this option due to the potential risk of excessive folic acid consumption for a signi?cant proportion of the population. The potentiai risks of excessive folic acid (above current recommended upper limits) are still reiatively unknown. Limited evidence suggests that excessive consumption may: i be detrimental for brain development in utero (Valera-Gran et al, 2014) 0 have implications for a portion of the population with genotype mutations of the gene, a mutation that impacts on folic acid metabolism. An unknown proportion of the population may be unable to efficiently metabolise folic acid at high intakes, ieading to an increase in homocystine levels and potentially an increased risk of associated negative health outcomes (Choi et ai, 203.4; Yates et al, 2016}. 0 Increase risk of some cancers (Office of the Prime Minister?s Chief Science Advisor, 2018; Yates et ai, 2016) As Choi et ai (2014) note in their publication on contemporary issues surrounding folic acid fortification, "Concerns notwithstanding, folic acid fortification has achieved enormous advances in public heaith. It therefore seems prudent to target and carefully monitor high risk groups, and to conduct well focused further research to better understand and to minimize any risk of mandatory folic acid fortification." 247). The DH 85 support this conclusion with regard to folic acid forti?cation of the food supply. References: Choi, i. H., Yates, 2., Veysey, M, Heo, Y. it, 8: tucock, M. (2014). Contemporary issues surrounding folic Acid fortification initiatives. Preventive nutrition and food science, 19(4}, 247-260. Office of the Prime Ministefs Chief Science Advisor Royal Society Te Aparangi (2018). Joint report of the 0PMCSA and Royai Society Te Aparangi: The health benefits 8: risks of folic acid fortification of food. Auckland: Office of the Prime Minister? 5 Chief Science Advisor. Valera-Gran, D., Hera, M. G. D. L, Navarrete-Mui?ioz. E. M., Fernandez-Somoano, A., Tard?n, A., Julvez,1., Vioque, J. (2014). Folic Acid Supplements During Pregnancy and Child Development After the First Year of Life. JAMA Pediatrics, 168(11]. doi: Yates, .Z, Lucock, M., Veysey, M, Choi, J.H. (2016) Elevated folic acid results in contrasting cancer cell line growth with impiications for mandatory folic acid fortification. Journal of Nutrition And Health Nutr Health 3 Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40?43 in the discussion paper. 8. DO YOU AGREE WITH THE APPROACH TO Agree. [3 Disagree. Unsure. Please explain why and provide any evidence you may have. Note: if you are one of the businesses that could be affected, what do you estimate the increased costs to be? No comment. General comments If you have any other general comments or suggestions for the Folic acid forti?cation: Increasing folic acid availability in food discussion paper, please let us know. PU HEALTH Waikato District Health Board Submission Review of folic acid fortification of food Ministry for Primary industries PO Box 2526 Wellington 6104 Food.Poiicy@mgi.govt.nz . Details of Submitter: Waikato District Health Board To: Consultation: Folic Acid Forti?cation ?0 Address for Service: Pubiic Health Unit Waikato District Health Board Private Bag 3200 HAMILTON 3240 Contact Person: Dr Richard Vipond ?4 1 Date: 16 October 2019 Hearing: We do not wish to be heard in support of our submission Introduction 1. Waikato District Health Board (Waikato DHB) presents this submission through its public health unit. The Public Health Unit is the principal source of advice within Waikato DHB regarding matters concerning Public Health. Waikato DHB has a duty of care and responsibility under the New Zealand Public Health and Disability Act 2000 to improve, promote and protect the health of people and communities. Additionally there is a to promote the reduction of adverse social and environmental effects on the health of people and communities.[1] With neariy 7000 staff, Waikato DHB provides health services to a population of over 400,000 people across the Waikato region, and tertiary-level services to the Midland region with a population of ova: 84000012] 2. Public Health has viewed the relevant documentation and offers the following comments for consideration. Our organisation has provided feedback in the format provided by the Ministry for Primary industries. 1 Page PUBLIC HEALTH Wuikafo District Health Board Q1 .The Problem The number of folic acid-sensitive Neural Tube Defects (NTD) affected pregnancies in New Zealand could be reduced if the blood folate levels of women of childbearing age were improved. Most women of chitdbearing age cannot get enough folate from natural food sources to ensure optimal blood folate levets for the prevention of NTDs. Supplementation only works for women who plan their pregnancies and know about the importance of taking folio acid tablets during the critical period of at least one month before and for the three months following conception. Around 53% of New Zealand pregnancies are unplanned. Some foods are voluntarily forti?ed with foiic acid. This is not enough however, to suf?ciently reduce the risk of affected pregnancies across the New Zealand population. I Do you agree with the problem as stated? Agree Disagree Unsure Unsure From information provided it is acknowledged that it is dif?cult for women of child bearing age to get suf?cient folio acid through natural sources to prevent NTDs. Folio acid supplementation is effective for women who plan their pregnancies and are aware of the importance of taking folio acid during this critical period; but around 53% of pregnancies in New Zealand are unplanned.[3] The burden of disease (NTDs) falls disproportionatiy on disadvantaged (socioeconorhioally), and indigenous populations, representing a(nother) faiting of the principals of Te Tiriti Waitangi and resulting in further inequity. In deferring the decision to make folic acid supplementation of bread mandatory previously, New Zealand has lagged behind more than 70 other countries which have been receiving the health, equity, social, and economic benefits of improved folate status and reduced objective of the review The objective of this review is to increase the consumption of food containing folio acid by women of childbearing age, thereby reducing the number of NTD?affeoted pregnancies. while considering consumer choice. increasing equity of health outcomes, and minimising impacts on industry. Do you agree with the objective of the review? Agree Disagree Unsure Unsure Having determined as above that folic acid consumption at a population level is insuf?cient to prevent NTDs (particularly in priority populations), and that voluntary supplementation has so far failed to reach these priority populations, this review needs to prioritise equity and health. Consumer choice is sometimes an excuse for inaction, however motivated individuals are normally able to maintain their free choice in issues such as these, and the concept of utilitarianism should not be forgotten about. impacts on industry may be an important consideration, however should be a secondary consideration after health and equity concerns, and are rareiy as signi?cant as may be lobbied. 2 Page PUBLIC HEALTH Waikuto District Health Board Option 1: Maintaining the status quo Option 1 would involve continued voluntary support by large bread bakers through their Code of Practice. Their goal is to fortify up to 50% of their packaged sliced bread, by volume. has assessed option 1 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 19 - in the discussion paper. 3. Do you agree with the assessment of the status quo against the criteria? Agree Disagree Unsure Unsure The assessment of the status quo has relative accuracy against the criteria. The ongoing equity shortcomings with this approach are not adequately highlighted. This approach has not worked thus far; there is no reason to conclude that maintaining the status quo will achieve the objectives. Option 2: Asking industry to enhance voluntary forti?cation Option 2 would involve asking industry (currently the large plant bakers) to voluntarily increase the volume of packaged sliced bread being forti?ed under the Code of Practice from the 2017 level of 38% to a new goal of 80%. MPI has assessed option 2 against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 22 24 in the discussion papen 4. Do you agree with the assessment of the enhanced voluntary forti?cation option against the criteria and like! impacts? Agree Disagree Unsure Unsure The assessment is once again relatively accurate. There needs to be a more concrete conclusion; enhanced voluntary forti?cation is unlikely to be achieved, be effective. or reduce inequity. For these reasons it is the preferred option for industry, but should not be considered further as a viabie option. Option 3a: Mandatory forti?cation of non-organic bread Option 3a would see bread forti?ed with folic acid at the bread-making stage. It would apply to all non-organic bread products, and include bread made from cereals other than wheat corn and rice bread). The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). MPI has assessed option 3a against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 26 29 in the discussion paper. 3iPage PUBLIC HEALTH Waikalo District Health Board 5. Do you agree with the assessment of mandatory folio acid fortification of bread against the criteria and iikely impacts? Agree Disagree Unsure Agree While being a preferable option to either 1 or 2 (from health or equity perspective), industry (and other) costs would make this option less favourable. There are better ways of achieving the objectives. Option 3b: Mandatory forti?cation of non-organic bread-making wheat) ?our Under option 3b, all non-organic wheat ?our for bread-making woutd be forti?ed with folic acid at the ?our?milling stage. in general, foiic acid is best added late in the milling process and at a point that ensures thorough and consistent mixing with the ?our. Cereals other than wheat that are processed into ?our for bread-making purposes would not be required to be forti?ed with folic acid (such as rice). Fiour used for purposes other than bread making wcuid not be required to be forti?ed. The Australia New Zealand Food Standards Code would continue to permit the voiuntary forti?cation of folic acid in other speci?ed foods (such as breakfast cereals). has assessed option 3b against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 30 -- 34 in the discussion paper. 6. Do you agree with the assessment of mandatory folio acid forti?cation of bread- making wheat ?our against the criteria and likely impacts? Agree Disagree Unsure Agree This option provides for the most cost effective means of achieving the objectives. Option 3c: Mandatory forti?cation of ati non-organic wheat ?our Option 3c would require the forti?cation of all non-organic wheat ?our, whether milled in New Zealand or imported from overseas. The Australia New Zealand Food Standards Code would continue to permit the voluntary forti?cation of folic acid in other speci?ed foods {such as breakfast cereals). has assessed option 3c against the criteria for health impacts, cost effectiveness, equity, consumer choice, and other impacts on pages 35 39 in the discussion paper. 7. Do you agree with the assessment of mandatory folic acid forti?cation of non- organic wheat flour against the criteria and likely impacts? Agree Disagree Unsure 4 Page PUBLIC HEALTH Waikato District Health Boord Agree While this option provides the best cost effectiveness and reduction in NTDs, there is likely to be opposition due to fears of exceeding upper limits of consumption in children and restricting personal choice. Implementation provides information on the proposed approaches to implementation for the three options presented on pages 40 43 in the discussion paper. 8. Do you agree with the approach to implementation? Agree Disagree Unsure 1' I Unsure Aspects of implementation and regulation need to be robust, transparent, and effective. It is suggested that the current voluntary approach has been ineffective. and maintenance of it, or an enhanced voluntary approach, will continue to be ineffective despite the method of impiementation. This will continue to increase inequity thus representing continued failings with respect to To Tiriti Waitangi. Should mandatory forti?cation be adopted (the recommendation of this submission), industry should be under no illusion that testing will be frequent (more so than proposed), with significant repercussions for non-compliance. Genera! comments . . This review of foiic acid forti?cation wouid bene?t from transparency regarding the fact that this issue has been considered or defened on more than one occasion previously. This has led to New Zealand falling behind other countries, further failings under Te Tiriti Waitangi, and an ineffective voluntary approach to forti?cation. There have been a number of families affected by NTDs unnecessarily. The current approach is ineffective. This submission is in favour of Option 38 as being the most effective and acceptable means of folic acid forti?cation to reach its objectives. Any of the option 3 choices however wouid be favourable to option 1 or 2. - Dr Richard Vipond Medical Of?cer of Health Public Health Waikato District Heaith Board SlPage