Complaint regarding the New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard 2009

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1 Complaint regarding the New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard 2009 Report of the Regulations Review Committee Forty-ninth Parliament (Charles Chauvel, Chairperson) August 2010 Presented to the House of Representatives

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3 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT I.16F Contents 1 Introduction 5 Recommendation 5 Complaint received 5 The Food Act The New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard Complaints process 6 2 Background 7 3 The complaint 9 SO 310(2)(a): The 2009 amendment food standard is not in accordance with the general objects and intentions of the Food Act 9 SO 310(2)(c): The 2009 amendment food standard appears to make unusual or unexpected use of the powers conferred by the Food Act 10 SO 310(2)(h): The 2009 amendment food standard was not made in compliance with particular notice and consultation procedures prescribed by the Food Act 11 Relief sought 11 4 The response 12 5 Committee determinations 16 6 Conclusions 21 Appendices A Committee members 22 B New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard C Relevant legislation 26 D Relevant Standing Orders 28

4 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT

5 INTRODUCTION I.16F 1 Introduction Recommendation The Regulations Review Committee recommends that the House take note of this report. Complaint received On 11 February 2010, we received a complaint from the New Zealand Organisation for Rare Disorders ( NZORD ) about the New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard NZORD is a registered charitable trust, set up in September 2000, which provides information, support, and advocacy about rare disorders, and builds networks to improve the efficiency of support groups, improve clinical care, and promote research to develop prevention, treatment and cure of rare disorders. The complaint focusses on the process of making the 2009 amendment food standard, which defers the commencement date for mandatory fortification of bread with folic acid, and the effect of that deferral in respect of neural tube defects. NZORD says that neural tube birth defects are largely preventable provided that females obtain sufficient folic acid at key times before and during pregnancy. The Food Act 1981 The Food Act 1981 is An Act to consolidate and amend the law relating to the sale of food. 2 The Food Act has purpose sections relating to specific parts of the Act, rather than a single purpose section relating to the entire statute. Part 2A of the Food Act 1981 deals with food standards, and its purposes are stated in section 11B. 3 Section 11C provides for the Minister for Food Safety to issue food standards. Section 11L provides for the Minister to amend or revoke food standards. Section 11E(1) sets out matters that the Minister must take into account before issuing, amending, or revoking a food standard. The first four matters specified in section 11E(1) are the same matters to which Parliament has stipulated due regard must be had in achieving the purposes set out in section 11B(a). In addition, section 11E(1) specifies a fifth matter the Minister is required to take into account, which is not specified in section 11B(a). 4 Section 11E(2) sets out consultation requirements. The New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard 2007 On 18 September 2007 the Hon Annette King, Minister for Food Safety, issued the New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard 2007, which 1 See Appendix B for a copy of relevant sections of the 2009 amendment food standard. 2 Long Title. 3 See Appendix C for a copy of relevant sections of the Food Act See section 11E(1)(e). 5

6 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT was gazetted on 27 September The 2007 food standard provided for the mandatory fortification of bread with folic acid. It was to come into force 24 months after gazettal, that date being 27 September On 26 August 2009 the Hon Kate Wilkinson, Minister for Food Safety, issued an amendment food standard delaying the introduction of mandatory fortification of bread with folic acid, and providing for voluntary fortification, until the end of 30 May Complaints process Under Standing Order 311, 5 where a complaint is made to us by a person aggrieved at the operation of a regulation, we must consider whether it relates, on the face of it, to one of the grounds on which we may draw a regulation to the special attention of the House. As a result of our initial deliberations, we decided that the complaint does relate to the operation of a regulation, and, on the face of it, to one or more of the grounds on which we may draw a regulation to the special attention of the House. We therefore decided to proceed with the complaint. We heard evidence relating to the complaint on 21 April Representatives appeared from NZORD and the New Zealand Food Safety Authority ( NZFSA ). 5 Appendix D contains relevant Standing Orders. 6

7 BACKGROUND I.16F 2 Background In May 2004, the Australia and New Zealand Food Regulation Ministerial Council 6 asked Food Standards Australia New Zealand ( FSANZ ) 7 to investigate mandatory folic acid fortification in bread to prevent neural tube defects. In October 2004, FSANZ released an Initial Assessment Report, presenting four options; status quo, extension of voluntary fortification permissions, mandatory fortification, and increased health promotion and education strategies. It received 72 submissions. In 2005, FSANZ issued a Draft Assessment Report, narrowing the options to mandatory fortification or status quo, and receiving 148 submissions. On 4 October 2006, FSANZ released its Final Assessment Report, recommending mandatory fortification of bread. On 18 September 2007, the Hon Annette King, Minister for Food Safety, issued the 2007 food standard. In 2008 there was a change of Government and the Hon Kate Wilkinson was appointed as Minister for Food Safety. She was briefed on mandatory folic acid fortification. Following expressions of consumer concern, Minister Wilkinson discussed the mandatory fortification issue with her Australian counterpart and was subsequently advised that Australia was comfortable with New Zealand taking its own course on this matter. The Minister then decided to consult on a possible amendment to the 2007 food standard. On 22 July 2009, the NZFSA issued a discussion paper entitled Proposed Amendment to the New Zealand Folic Acid Standard ( discussion paper ), which identified key concerns about the 2007 food standard, and included three options: maintaining the status quo, revoking the 2007 food standard, or delaying its commencement. Submissions responding to the discussion paper were due by 12 August On 20 August 2009, the Minister was briefed in a paper ( the briefing paper ) on the outcome of the consultation on the proposed amendment. The briefing included an overview of submissions received, noting that 61 preferred the status quo option, 42 preferred the revocation option, and 19 preferred the option of delaying the commencement date for mandatory fortification. 6 The Australia and New Zealand Food Regulation Ministerial Council is primarily responsible for the development of domestic food regulatory policy and the development of policy guidelines for setting domestic food standards. 7 FSANZ is a bi-national Government agency. Its main responsibility is to develop and administer the Australia-New Zealand Food Standards Code, which lists requirements for foods such as additives, food safety, labelling and GM foods. 7

8 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT On 26 August 2009 Minister Wilkinson issued the 2009 amendment food standard. 8

9 THE COMPLAINT I.16F 3 The complaint This section summarises the matters raised by NZORD that we consider significant. NZORD bases its complaint on three grounds set out in the Standing Orders of the House of Representatives 2008: SO 310(2)(a): The 2009 amendment food standard is not in accordance with the general objects and intentions of the Food Act SO 310(2)(c): The 2009 amendment food standard appears to make unusual or unexpected use of the powers conferred by the Food Act. SO 310(2)(h): The 2009 amendment food standard was not made in compliance with particular notice and consultation procedures prescribed by the Food Act. SO 310(2)(a): The 2009 amendment food standard is not in accordance with the general objects and intentions of the Food Act NZORD says that the 2009 amendment food standard does not accord with the objects and intentions of the Food Act in relation to food standards, which are set out in section 11B. Specifically NZORD says that the decision of the Minister for Food Safety to issue the 2009 amendment food standard does not accord with the need to protect public health, with international food trends, or with New Zealand s international obligations, and also does not give effect to the Australia-New Zealand Joint Food Standards Agreement ( joint treaty ). The need to protect public health NZORD is not satisfied that the Minister took into account all public health benefits in her consideration of section 11E(1)(a). NZORD says that the public health benefit of adding folic acid to bread is that neural tube defects are reduced. It says that the Minister s decision to postpone the introduction of mandatory fortification of bread with folic acid will result in the death or serious disability of 4 to 14 children for each year that the delay continues, affecting 10 to 35 pregnancies for the planned period of delay. NZORD says that the word need, as used in section 11B(a)(i), is a clear directive from Parliament that the Minister has a duty to protect public health and to give effect to New Zealand s obligations under any relevant treaty. NZORD recognises that the NZFSA draws a distinction between promoting and protecting public health, but says that the distinction is too narrow and that the promotion and protection of public health go handin-hand. NZORD also says that mandatory fortification would bring New Zealand into line with numerous other jurisdictions, including Australia, the USA, Canada, and Chile which, recognising the health benefits of folic acid fortification, have already made it mandatory. 9

10 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT New Zealand s relevant international treaty obligations NZORD says that the briefing paper to the Minister on New Zealand s obligations under any relevant treaty addresses only the joint treaty, and that the Minister therefore failed to have regard to any other relevant international obligations, such as those set out in the International Covenant of Economic, Social and Cultural Rights. 8 Other matters the Minister considers appropriate The Minister took into account other matters, specifically Government policy objectives, consumers choice, and the concern expressed by consumers and industry. NZORD thinks that much of the consumers concern resulted from misinformation about health risks, and questions the weight the Minister gave to them. NZORD says that while section 11E(1)(e) may allow the Minister to take into account other matters, the ultimate decision should be consistent with the purpose of the powers, as set out in section 11B. In this case, NZORD thinks that the Minister s focus was dominated by matters considered under section 11E(1)(e) in a manner contrary to the purposes specified in section 11B. The joint treaty NZORD says that the 2009 amendment food standard contravenes New Zealand s obligations under the joint treaty. NZORD says that the Minister is constrained by the limits of the power delegated by Parliament in section 11B(b) to give effect to the joint treaty, and argues that it is beyond the scope of the delegated power for the Minister to consider that in this instance she does not need to give effect to the joint treaty, even on the basis that her Ministerial counterpart in Australia has advised that Australia would not be concerned if New Zealand chose to change the 2007 food standard mandatory fortification requirement. SO 310(2)(c): The 2009 amendment food standard appears to make unusual or unexpected use of the powers conferred by the Food Act NZORD proposes that the way the Minister used the powers conferred on her by the Food Act was unusual and unexpected in a number of ways: The Minister issued the 2009 amendment food standard in deliberate contravention of the joint treaty. One of the purposes of the Food Act is expressly stated as In particular, to give effect to the Australia-New Zealand Joint Food Standards Agreement. 9 The Minister rushed consultation on the 2009 amendment food standard despite there being no exceptional circumstances or fresh issues requiring consideration, and in circumstances where haste was necessary only in order to deliver a predetermined outcome. 8 See Article and See section 11B(b) of the Food Act

11 THE COMPLAINT I.16F The Minister, using a general policy ground, 10 has elevated consumer choice above expressly stated policy grounds in the Food Act. The Minister failed to do enough to allay claims of supposed health risks from adding folic acid to bread, and, in any case, the 2009 amendment food standard only delays rather than scraps mandatory fortification. The Minister failed to consider the food standard relating to iodine in the process of considering amendment of the 2007 food standard. NZORD says this is unusual or unexpected when the legal arguments and scientific evidence in relation to the two matters are similar. The Minister deferred mandatory fortification despite overwhelming evidence of public health benefits and clear international precedents. SO 310(2)(h): The 2009 amendment food standard was not made in compliance with particular notice and consultation procedures prescribed by the Food Act NZORD is of the view that the consultation process was woefully inadequate. It says: The discussion paper failed to include all of the information necessary to enable genuine consultation; in particular it made no mention of the supposed public health risks that had been discussed in the media. The period for submitters to respond was too short to allow genuine consultation, and the period provided for the NZFSA to consider submissions was not sufficient for adequate and appropriate consideration of the submissions. The consultation was not genuine. The Minister predetermined the outcome she wanted then performed a consultation process to achieve it. The degree of predetermination was such that the process was in effect a charade. The Minister and the NZFSA in effect undertook a process of notification rather than a process of consultation. Relief sought NZORD asks the committee to draw the 2009 amendment food standard to the special attention of the House of Representatives, moving a motion to either disallow the 2009 amendment food standard, or, alternatively, to amend the 2009 amendment food standard to introduce mandatory fortification of bread with folic acid and revoke voluntary fortification with effect from the earliest possible date. 10 Section 11E(e) of the Food Act other such matters as the Minister considers appropriate. 11

12 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT 4 The response This is a summary of the matters raised by the NZFSA that we consider significant. The NZFSA does not accept that the 2009 amendment food standard, either as a whole, or clause 4, is in breach of Standing Orders. SO 310(2)(a): The 2009 amendment food standard is not in accordance with the general objects and intentions of the Food Act The NZFSA says that the 2009 amendment food standard is consistent with the intentions of the Food Act as a whole. It also says that the regulation-making power in the Food Act authorises the Minister for Food Safety to issue and amend food standards. The need to protect public health The NZFSA does not agree with NZORD s interpretation of the relevant Food Act provisions. The NZFSA says that section 11B is directional not absolute, in that its purpose is to allow more flexibility in regulating food, while having regard to certain factors. Section 11B is a general purpose statement and an interpretational tool, not a precondition. It does not create active and positive duties on the Minister to protect public health or give effect to international obligations. Section 11E sets out the statutory preconditions to the exercise of the Minister s power. It requires the Minister to take certain factors into account but does not require her to give effect to them in absolute terms. The NZFSA says that the difference between health promotion and health protection is essentially the difference between the role of the Ministry of Health and its own. The NZFSA s priority is the safety and suitability of food, that is, health protection. The NZFSA says that the voluntary fortification provided for in the 2009 amendment food standard is in itself a public health measure that reflects regard to the need to protect public health. The NZFSA is of the view that the Minister s decision to defer the commencement of the 2007 food standard took into account the accepted evidence of the benefit of folic acid in reducing neural tube defects. The decision was also influenced by the fact that a review of the FSANZ Standard is planned for New Zealand s relevant international treaty obligations The NZFSA says that the Minister took account of the joint treaty, as further discussed below. Referring to NZORD s submission that the Minister has failed to take account of the International Covenant on Economic, Social and Cultural Rights, the NZFSA says that the targeted voluntary fortification programme and other steps such as targeted education are measures to reduce infant mortality. 12

13 THE RESPONSE I.16F Other matters the Minister considers appropriate In respect of the other matters the Minister took into account in making her decision, the NZFSA says the following: It is every Government s right to set policy objectives and this is not a matter of less significance than those expressly stated in section 11E. There was a clear message of concern in the majority of consumer submissions, and also in correspondence received by the Minister before the consultation on the 2009 amendment food standard. Consumers concern was significant, whatever lay behind it, and it was addressed in the briefing paper. Lack of choice and the perceived impracticality or expense of the options that were intended to be exempt from mandatory fortification requirements were consistent themes in consumers submissions and correspondence. The joint treaty The NZFSA says that the relationship with Australia and the joint treaty was a key factor throughout the Minister s consideration of the future of the 2007 food standard. Steps were taken to keep the treaty partner, Australia, fully informed and in agreement with the proposed approach. It was not until Australia advised that it was comfortable with New Zealand taking its own course that the Minister decided to consult on a possible amendment. The NZFSA says that the statutory requirement of taking particular account of the joint treaty was therefore satisfied. SO 310(2)(c): The 2009 amendment food standard appears to make unusual or unexpected use of the powers conferred by the Food Act The NZFSA says that central to this ground is Parliament s intention regarding the Food Act. Section 11C enables the Minister to issue food standards. The Act also expressly provides for the issuing, amendment, and revocation of food standards. The NZFSA says that issuing the 2009 amendment food standard is not an unusual or unexpected use of the powers conferred by statute; and further, it argues as follows: The power to issue a food standard was not used to breach the joint treaty. The process was undertaken in full consultation with, and with the agreement of, Australia. Although the consultation timeframe was relatively short, officials went to considerable lengths to ensure that submitters had as long as possible to respond and had access to the relevant FSANZ reports. Consumer choice is a relevant consideration and is specifically referred to in the FSANZ Act as an objective that guides the development of food regulatory measures. 11 In terms of the development of food standards under the joint system, New Zealand and Australia operate under the Food Standards Australia New Zealand Act

14 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT Mandatory fortification with folic acid and iodine were considered in tandem, and the dates on which they were to come into force were synchronised to minimise the impact on industry. This does not mean that the consultation on one, and not the other, is flawed. The weight placed on matters considered was a decision for the Minister. The NZFSA notes that decisions concerning food standards not infrequently raise issues of competing interests involving health benefits and international developments, but that does not make the outcome an unusual or unexpected use of power. SO 310(2)(h): The 2009 amendment food standard was not made in compliance with particular notice and consultation procedures prescribed by the Food Act The NZFSA does not accept that what occurred was a notification of a predetermined outcome rather than a consultation, and submits that the process adopted was adequate in the circumstances. The NZFSA accepts that the consultation document was comparatively brief and the consultation period was short compared with the usual timeframes regarding food standards. However, the timeframe was necessarily short to accommodate a decision on the options before mandatory measures provided for in the 2007 food standard came into force. In addition, the NZFSA says that the consultation round was about the potential deferral of an existing regulatory measure rather than the imposition of a new one, and the issue of mandatory folic acid fortification has been under consideration since It notes that prior consultation on folic acid fortification had been carried out. The NZFSA says that to help mitigate the effects of the short consultation period, it committed considerable resources to the process. It established a senior officials team to ensure high quality analysis could be done quickly, contacted key stakeholders directly to advise them that consultation was about to commence, and met with NZORD to discuss elements of the consultation document. The NZFSA says that the quality, nature, and number (123) of submissions it received show that the time and information provided for consultation was sufficient. As to the complaint of predetermination, the NZFSA says that the Government is entitled to have a working plan in mind, and that it indicated its preferred approach in the discussion paper. The NZFSA says that what is important is that the Minister did not make a final decision until the consultation process had been undertaken. Consultation was not a charade, and the final decision does not reflect a predetermined outcome or the product of a mind completely closed to alternatives. Relief sought In the event that we find the complaint substantiated, the NZFSA makes the following points. Disallowance would create an array of legal and administrative issues. An entire industry, which has been working with the previous and current Government towards voluntary measures, would be retrospectively non-compliant, and operating illegally during 14

15 THE RESPONSE I.16F the relevant period. The NZFSA says that legislation should deal with future acts and not alter the character of past transactions. The NZFSA also notes that the committee has discretion as to whether it should draw a regulation to the attention of the House. It suggests that its points above, and the fact that the 2011 FSANZ review of mandatory folic acid fortification is imminent, weigh against the committee taking this course of action. 15

16 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT 5 Committee determinations Our considerations and conclusions on the matters we consider significant are summarised below. In reaching our decision, we have considered Standing Orders, the 2007 food standard, the 2009 amendment food standard, the Food Act 1981 and the written and oral evidence given by NZORD and the NZFSA. Our role Our committee s focus is technical scrutiny, not scrutiny of policy. We respect the separation of powers between Parliament, the Executive and the Judiciary. Therefore, it is not appropriate for us to comment on the 2009 amendment food standard s policy, as this is a legitimate matter for the Executive to determine. Our role is to consider the complaint against the grounds set out in the Standing Orders, focussing on the technical aspects of the delegated legislation that are pertinent to this complaint. SO 310(2)(a): The 2009 amendment food standard is not in accordance with the general objects and intentions of the Food Act It is clear that the Minister for Food Safety has the power to issue and amend food standards such as the 2009 amendment food standard. Our focus has been on whether the Minister has done so in accordance with the general objects and intentions of the Food Act as they are set out in section 11B, including whether she took into account the matters set out in section 11E(1). NZORD did not argue that the purpose of the 2009 amendment food standard was not To provide for greater flexibility in the regulatory arrangements relating to food manufactured or prepared for sale or sold in New Zealand, or imported into New Zealand. 12 Instead NZORD focussed on the subparagraphs of section 11B(a), and whether the Minister adequately considered the matters specified in each of those subparagraphs. We have seen the briefing paper that updated the Minister on the outcome of consultation undertaken on the then proposed 2009 amendment food standard. The briefing paper addresses the food standards statutory framework, specifically considering each of the matters set out in sections 11B(a) and 11E(1), as well as considering such matters throughout its course. 13 Such other matters considered under section 11E(1)(e) are identified in the briefing paper as Government policy objectives, the impact on consumer choice, and the amount of concern expressed by consumers and industry. Consumer choice and support is also discussed elsewhere in the briefing paper, which notes, amongst 12 Section 11B(a). 13 As examples of places where protection of public health matters are raised other than under the heading The need to protect public health at paragraph 52, see paragraphs 21 and paragraphs 28 to

17 COMMITTEE DETERMINATIONS I.16F other things, some submissions to the effect that consumer concern was largely caused by misinformation. 14 NZORD was also concerned about the Minister s exercise of her powers taking into account New Zealand s obligations under the joint treaty, and the delegation Parliament has made to the Minister. Section 11B(b) states that a purpose of Part 2A of the Act, which relates to food standards, is to give effect to the joint treaty, while section 11E(d) requires the Minister to take account of the joint treaty in issuing the 2009 amendment food standard. There is a disagreement between NZORD and the NZFSA about the meaning of section 11B(b) and section 11E(1)(e). We have considered whether the Minister properly considered the joint treaty, not whether the decision she made was right or wrong. It is clear to us that the Minister discussed with her Australian counterpart New Zealand s responsibilities regarding mandatory fortification with folic acid in the context of the joint treaty. This was specifically mentioned in the briefing paper. She was, in essence, advised that Australia would not be concerned if New Zealand took a different path to the one previously agreed and instigated in the 2007 food standard. Taking into account the requirements of the Food Act and the evidence presented to us by each party, we are of the view that there is no good reason to conclude that the Minister for Food Safety did not consider matters relating to each matter set out in sections 11B(a), 11B(b) and section 11E(1). Therefore, in our view, the complainant has not made out this ground of complaint. SO 310(2)(c): The 2009 amendment food standard appears to make unusual or unexpected use of the powers conferred by the Food Act Having considered the submissions made by NZORD and the NZFSA, we have reached the following decisions: The requirements in sections 11B and 11E were to have due regard to and take into account the joint treaty. It appears to us that the Minister had due regard to the joint treaty, taking it into account in her decision-making process. She did not decide to go ahead with consultation on the proposed amendment until she had received word from her Australian counterpart that Australia was comfortable with New Zealand taking its own course on this matter. We have considered the complainant s submission that the section 11E(1)(e) considerations came to dominate. We are of the view that the Minister considered matters relating to each subparagraph, including section 11E(1)(e). We refer to the briefing paper, which contains advice on the matters set out in each of the subparagraphs in section 11E. We discuss consultation in more detail under the next heading; however, we note here that we believe that the consultation process was adequate. 14 See paragraphs 38 to

18 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT We note that two of our members, Moana Mackey and Jacinda Ardern, do not share the majority opinion. Their view is that the way the Minister used the powers conferred on her by the Food Act was unusual and unexpected for the following reasons: It contravened the joint treaty. They consider that the purpose set out in section 11B(a)(iv) and the precondition in section 11E(1)(d) require more than an informal agreement between our Minister and her Australian counterpart to contravene the joint treaty. They think the consultation process was not adequate and that making the 2009 amendment food standard was therefore unusual and unexpected. However, we have concluded that the use of the Food Act to issue the 2009 amendment food standard on mandatory fortification of bread with folic acid is not an unexpected or unusual use of the powers conferred on the Minister by the Food Act. Our decision is that NZORD has not made out this ground of complaint. SO 310(2)(h): The 2009 amendment food standard was not made in compliance with particular notice and consultation procedures prescribed by the Food Act NZORD has raised some serious concerns about the consultation carried out in this case, particularly alleging predetermination and questioning the time allowed for consultation. The issue before us is not whether consultation was carried out before the 2009 amendment food standard was issued, as it is clear that it was. Our role is to satisfy ourselves that the consultation process complied with the procedures prescribed by the Food Act, including the requirement that the Minister could be satisfied that it was sufficient to meet the Food Act s requirements. The Food Act provides that the Minister will not issue a food standard unless satisfied that appropriate consultation has been carried out. It specifically requires the Minister to consider whether there was adequate and appropriate notice of the intention to issue the food standard, whether there was a reasonable opportunity for interested persons to make submissions, and whether there was adequate and appropriate consideration of any submissions. 15 In this case, we consider that the consultation period was brief, but not unreasonably so. The discussion paper was issued on Wednesday, 22 July Submissions were required to be submitted no more than three weeks later, by Wednesday, 12 August The time allowed for analysing the submissions was two weeks, from Wednesday 12 August 2009 until Wednesday 26 August The NZFSA itself recognises that the consultation period was short. The NZFSA says that it was constrained by the fact that the mandatory fortification of bread requirement provided for in the 2007 food standard was due to come into effect in late September 2009 and that consultation had to be short to accommodate this date. 15 See section 11E(2). 18

19 COMMITTEE DETERMINATIONS I.16F The length of consultation is one of the matters we have considered in reaching a decision on this part of the complaint. In addition, we have also taken into consideration the fact that the NZFSA, recognising the short time available for the consultation process, took considerable steps to mitigate the resulting pressure, including personally advising a number of key stakeholders of the commencement of consultation and committing an experienced senior officials team to the task of analysing submissions. We also understand that 123 submissions were received, which the NZFSA told us was roughly three times the number usually received for a routine consultation. The committee found by majority that while the consultation period was comparatively short, it was not so short as to lead us to conclude that it was not reasonable to expect interested people to become aware of and make submissions on the issue. In addition, we accept that the NZFSA had an experienced team analyse the submissions and contact potential submitters directly to inform them of the discussion document, in an attempt to mitigate constraints placed by the short time available for consultation. We note the number of submissions received. We are also aware that this matter has been in the public domain since at least 2004 when the process of consultation and consideration began for the 2007 food standard, so it was not a case of the public being asked to come to terms with an entirely new issue in a short time. However, three members of our committee, Charles Chauvel, Moana Mackey and Jacinda Ardern, consider that the consultation did not comply with particular notice and consultation procedures prescribed by the Food Act. In particular, they question the quality of the consultation. They think that, since the Minister had made so public her preferred option of deferring mandatory fortification of bread with folic acid, a meaningful consultation process was all the more important to militate against questions of predetermination. In this case, they think that the consultation period was too short. They are not persuaded by the argument that the timeframe was constrained by the late September 2009 deadline, as they say that the Government was in the position to extend that deadline to provide more time to consult on the proposed amendment to the 2007 food standard. They are not convinced that the NZFSA s step to target key submitters by contacting them directly was sufficient to mitigate the pressures resulting from the short timeframe. Amongst other things, they say this could mean that people who had not been, or seen a need to be, publicly involved before the discussion paper was issued might not have had an opportunity to make submissions, as no-one would have known to contact them. They question the possibility of meaningful consultation if the timeframe is too short for people to make high-quality submissions, or even any submission. They say that wider consultation might have resulted in a different outcome. Finally, we wish to comment on the allegation of predetermination. It is clear that the Government had a preferred option, which was to defer the commencement date for mandatory fortification. This was expressly recognised in the discussion document, and statements to such effect were made by the Minister in other forums. However, on the basis of the evidence we have received, both oral and written, a majority of us have concluded that the Government was open to other options, even though it had a preferred option. Our decision is that NZORD has not made out this ground of complaint. We are of the view that, although not perfect, the standard of consultation was sufficient to meet the 19

20 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT requirements of the Food Act, and we therefore conclude that the 2009 amendment food standard was made in compliance with the particular notice and consultation procedures prescribed by the Food Act. We have decided that the complainant has not made out this ground of complaint. 20

21 CONCLUSIONS I.16F 6 Conclusions As a result of our consideration of the matters raised in this complaint, we have concluded that the 2009 amendment food standard is in accordance with the general objects and intentions of the Food Act 1981 does not appear to make unusual or unexpected use of the powers conferred by the Food Act was made in compliance with particular notice and consultation procedures prescribed by the Food Act

22 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT Appendix A Committee members Charles Chauvel (Chairperson) Amy Adams Jacinda Ardern (until 22 July 2010) Aaron Gilmore Chris Hipkins (from 22 July 2010) Rahui Katene Tim Macindoe Moana Mackey 22

23 APPENDIX B I.16F Appendix B New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard 2009 Pursuant to sections 11C and 11L of the Food Act 1981, I, Kate Wilkinson, Minister for Food Safety, issue the following standard for the purpose of amending the New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard Issued at Wellington this 26th day of August 2009 (Signed) Hon Kate Wilkinson Minister for Food Safety Certified in order for signature (Signed) Solicitor 25/08/2009 Published by the New Zealand Food Safety Authority PO BOX 2835, Wellington 1 Title 2 Commencement 3 Principal standard amended 4 New clause 2 substituted 5 New clauses 3 and 3A substituted 6 New Parts 2A and 2 substituted 7 New clause 7 substituted Contents Standard 1 Title This standard is the New Zealand (Mandatory Fortification of Bread with Folic Acid) Amendment Food Standard Commencement This standard comes into force on 25 September Principal standard amended This standard amends the New Zealand (Mandatory Fortification of Bread with Folic Acid) Food Standard 2007 (the principal standard). 23

24 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT 4 New clause 2 substituted The principal standard is amended by revoking clause 2 and substituting the following clause: 2 Commencement (1) This standard (except Part 2) comes into force on 25 September (2) Part 2 of this standard comes into force on 31 May New clauses 3 and 3A substituted The principal standard is amended by revoking clause 3 and substituting the following clauses 3 and 3A: 3 Purpose This standard provides for (a) the voluntary fortification of bread with folic acid (and Lmethyltetrahydrofolate, calcium) until the end of 30 May 2012; and (b) the mandatory fortification of bread with folic acid on and after 31 May A Meaning of bread In this standard, bread has the meaning given to it in Standard (Cereals and Cereal Products) in the Australia New Zealand Food Standards Code. 6 New Parts 2A and 2 substituted The principal standard is amended by revoking Part 2 (including the title and the explanatory box) and substituting the following Parts: Part 2A Permitted addition of folic acid to bread (temporary) 4 Expiry of Part This Part expires at the end of 30 May Addition of folic acid to bread permitted Folic acid or L-methyltetrahydrofolate, calcium may be added to bread. Part 2 Mandatory addition of folic acid to bread 6 Mandatory addition of folic acid to bread (1) Bread must contain no less than 0.8 mg/kg and no more than 1.8 mg/kg of folic acid. (2) Subclause (1) does not apply to bread that is represented as organic. 7 New clause 7 substituted The principal standard is amended by revoking clause 4 and substituting the following clause 7: 24

25 APPENDIX B I.16F 7 Applicable standards in the Australia New Zealand Food Standards Code This standard does not affect any additional obligations or restrictions relating to the manufacture and sale of bread specified in the Australia New Zealand Food Standards Code that are applicable in New Zealand. Food Standards subject to Regulations (Disallowance) Act 1989 Food standards, including this standard, are subject to the Regulations (Disallowance) Act Any person has the right to make a complaint about a food standard to the Regulations Review Committee. Availability of food law An outline of New Zealand food law, including copies of New Zealand Food Standards can be viewed on the New Zealand Food Safety Authority (NZFSA) web site: or can be obtained from the NZFSA, Policy Group, PO Box 2835, Wellington. 25

26 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT Appendix C Relevant legislation Part 2A Food standards Purposes of this Part 11B Purposes of this Part The purposes of this Part of this Act are (a) To provide for greater flexibility in the regulatory arrangements relating to food manufactured or prepared for sale or sold in New Zealand, or imported into New Zealand, having due regard to the following matters: (i) The need to protect public health: (ii) The desirability of avoiding unnecessary restrictions on trade: (iii) The desirability of maintaining consistency between New Zealand's food standards and those applying internationally: (iv) The need to give effect to New Zealand's obligations under any relevant international treaty, agreement, convention, or protocol; and (b) In particular, to give effect to the Australia-New Zealand Joint Food Standards Agreement. Power to issue food standards 11C Minister may issue food standards (1) The Minister may from time to time issue standards in respect of food manufactured or prepared for sale or sold in New Zealand, or imported into New Zealand. (2) Without limiting the generality of subsection (1) of this section, standards may be issued under that subsection for the purposes of, or in relation to, all or any of the following: (a) Food safety: (b) The composition of food, including (without limitation) (i) The maximum amounts of contaminants or residues that may be present in food: (ii) The maximum or minimum amounts of additives or other substances that must or may be present in food: (iii) The microbiological status of food: (c) The production, manufacture, and preparation of food: (d) The genetic modification of food: (e) The sampling and testing of food to determine its composition or safety: (f) The packaging, storage, and handling of food: 26

27 APPENDIX C I.16F (g) Materials, containers, appliances, and utensils used, or designed for use, in relation to food: (h) The carriage and delivery of food: (i) The sale of food: (j) Information about food, including (without limitation) the labelling, promotion, and advertising of food: (k) Food safety programmes: (l) The keeping of records by persons who import, produce, manufacture, prepare, pack, store, handle, carry, deliver, or sell food, and the inspection of such records: (m) Such other matters relating to food as may affect public health. 11E Preconditions for issuing food standard (1) In issuing any food standard, the Minister shall take into account the following: (a) The need to protect public health: (b) The desirability of avoiding unnecessary restrictions on trade: (c) The desirability of maintaining consistency between New Zealand's food standards and those applying internationally: (d) New Zealand's obligations under any relevant international treaty, agreement, convention, or protocol, and, in particular, under the Australia-New Zealand Joint Food Standards Agreement: (e) Such other matters as the Minister considers appropriate. (2) The Minister shall not issue any food standard unless the Minister is satisfied that appropriate consultation has been carried out with respect to the food standard, including (without limitation) (a) Adequate and appropriate notice of the intention to issue the food standard; and (b) A reasonable opportunity for interested persons to make submissions; and (c) Adequate and appropriate consideration of any such submissions. General provisions relating to food standards 11L Amendment and revocation of food standards (1) The Minister may at any time amend or revoke any food standard. (2) Subject to subsection (3) of this section, the provisions of sections 11E to 11K of this Act shall apply in respect of any amendment or revocation of any food standard. (3) Nothing in section 11E(2) of this Act applies in respect of any amendment to any food standard to correct any obvious mistake (including, without limitation, grammatical and typographical errors or omissions). 27

28 FOLIC ACID AMENDMENT FOOD STANDARD COMPLAINT Appendix D Relevant Standing Orders 309 Functions of Regulations Review Committee (1) The Regulations Review Committee examines all regulations. (2) A Minister may refer draft regulations to the committee for consideration and the committee may report on the draft regulations to the Minister. (3) In respect of a bill before another committee, the committee may consider (a) any regulation-making power, (b) any provision that contains a delegated power to make instruments of a (c) legislative character, and any matter relating to regulations, and report on it to the committee that is considering the bill. (4) The committee may consider any matter relating to regulations and report on it to the House. (5) The committee investigates complaints about the operation of regulations, in accordance with Standing Order 311, and may report on the complaints to the House. 310 Drawing attention to a regulation (1) In examining a regulation, the committee considers whether it ought to be drawn to the special attention of the House on one or more of the grounds set out in paragraph (2). (2) The grounds are, that the regulation (a) is not in accordance with the general objects and intentions of the statute under which it is made: (b) trespasses unduly on personal rights and liberties: (c) appears to make some unusual or unexpected use of the powers conferred by the statute under which it is made: (d) unduly makes the rights and liberties of persons dependent upon administrative decisions which are not subject to review on their merits by a judicial or other independent tribunal: (e) excludes the jurisdiction of the courts without explicit authorisation in the enabling statute: (f) contains matter more appropriate for parliamentary enactment: (g) is retrospective where this is not expressly authorised by the empowering statute: (h) was not made in compliance with particular notice and consultation procedures prescribed by statute: (i) for any other reason concerning its form or purport, calls for elucidation. 311 Procedure where complaint made concerning regulation (1) Where a complaint is made to the committee or to the chairperson of the committee by a person or organisation aggrieved at the operation of a regulation, the complaint 28

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