See also the scientific report that was subsequently produced...

Complaint relating to the New Zealand Food Standard 1996, Amendment No. 11

Report of the Regulations Review Committee
FORTY-FIFTH PARLIAMENT
(RT HON JONATHAN HUNT, CHAIRPERSON)

July 1999

Presented to the House of Representatives

CONTENTS

Introduction

Background

Legislative context of food standards
History of Amendment 11

Examination of complaint under Standing Order 197 (2)

Not in accordance with general objects and intentions of the Act

Risk assessment of bee products
Comparative risk assessment with other foods
Lack of scientific evidence to establish need to protect public health
Concluding comments

Consistency with regulation of other foods
Consistency with international practice
Full review of food allergens underway
Voluntary warnings used by 75 to 95 percent of industry
Amendment driven by Australian warnings

Not made in compliance with consultation procedures prescribed by statute

Consultation requirements have been considered by the Courts

Associate Minister establishes a review

Recommendation

Appendices (not included on this web page)

Appendix A Committee personnel and conduct of the examination
Appendix B Standing Orders 195 to 198
Appendix C Written evidence considered by the committee
Appendix D Excerpts from the Food Act 1981

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Recommendation

A majority of us recommend to the Government that the New Zealand Food Standard 1996, Amendment No. 11 be revoked.

Introduction

We resolved on 17 February 1999 to proceed with an investigation of the complaint. We forwarded the complaint to the Minister of Health (the Minister) for comment. We also asked representatives of the bee industry to address their concerns about the amendment to the grounds in Standing Order 197(2). We received submissions from the National Nutritional Foods Association of New Zealand (NNFA) and the New Zealand Charter of Health Practitioners Incorporated (NZCHP).

This report begins with a summary of the amendment and its authorising legislation and an outline of the grounds of the complaint. We then detail our consideration of the complaint under the grounds in Standing Order 197(2), our conclusions, and recommendation to the Government. The committee's personnel and conduct of the examination are attached as Appendix A. The Standing Orders relevant to the Regulations Review Committee are attached as Appendix B. A complete list of all written evidence considered by the committee is attached as Appendix C.

Appendix D contains excerpts from the Food Act 1981.

Background

Legislative context of food standards

Food standards, whether set by regulations or issued by the Minister, set minimum requirements for food. These requirements are currently set out in the New Zealand Food Regulations 1984, the Dietary Supplements Regulations 1985, the New Zealand Food Standards, and the Food Hygiene Regulations 1974.

Food standards issued by the Minister are deemed to be regulations for the purposes of the Regulations (Disallowance) Act 1989 (although not for the purposes of the Acts and Regulations Publication Act 1989).[Section 11I Food Act 1981]. This means that although food standards are not published in the annual Statutory Regulations series, they are subject to parliamentary scrutiny by the Regulations Review Committee once they have been tabled in Parliament. The House of Representatives may, by resolution, disallow any regulations under the Regulations (Disallowance) Act 1989 [Section 5(1)].

The Food Act 1981 sets out certain preconditions in section 11E for issuing a food standard [See Appendix D].

Before a food standard is issued the Minister shall take into account the following

• the need to protect public health

• the desirability of avoiding unnecessary restrictions on trade

• the desirability of maintaining consistency between New Zealand's food standards and those applying internationally

• New Zealand's obligations under any relevant international treaty, in particular the Australia New Zealand Joint Food Standards Agreement

• such other matters that the Minister considers appropriate.

A joint food standards code between Australia and New Zealand is under development. In the interim the Australian Food Standards Code (AFSC) is recognised as an alternative to most food standards in the New Zealand Food Regulations.

The Governments of Australia and New Zealand have signed a Treaty to establish a joint food standards setting system, called the Agreement Between the Government of New Zealand and the Government of Australia Establishing a System for the Development of Joint Food Standards (the Treaty). This agreement commenced in July 1996.

The underlying precept of the joint system is that the needs of both New Zealand and Australia must be considered, the public health of both countries protected and unnecessary barriers to trade reduced.

New Zealand is obliged to adopt standards recommended by ANZFA and agreed to by the Australia New Zealand Food Standards Council unless there are exceptional reasons (for example to protect public health) or a standard is outside the scope of the Treaty (for example those for dietary supplements).

History of Amendment 11

In December 1997 ANZFA introduced a revised royal jelly warning under the urgency provisions contained in the Australia New Zealand Food Authority Act 1991. ANZFA acted following an Australian coroner's finding in June 1997 that royal jelly caused a death. This was the third death linked to royal jelly in Australia. The revised warning strengthened the existing warning by including a reference to "fatalities". Following ANZFA's action the Ministry of Health (the ministry) began assessing the need for mandatory warning labels for bee products in New Zealand.

The revised warning adopted by ANZFA could not be implemented immediately in New Zealand because of the requirement to consult before the Minister can issue a food standard, as set out in the New Zealand Food Act 1981. The ministry had previously responded to concerns about royal jelly by informing the New Zealand industry of risks and recommending the use of voluntary warning labels.

Under the Treaty, New Zealand was required to respond to ANZFA's recommendation for a royal jelly warning. After an initial investigation, the ministry proposed mandatory labelling of products containing royal jelly, bee pollen, and propolis. The mandatory labelling requirements were to cover foods including dietary supplements. A consultation process was carried out by the ministry, which then made recommendations to the Minister in October 1998.

The Minister signed the amendment on 8 December 1998 and it was gazetted on 17 December 1998. The Minister, by way of a notice of suspension, suspended the commencement date from 17 February 1999 until 17 April 1999.

The amendment requires the following warnings be applied to products containing royal jelly, bee pollen or propolis.

In the case of a product comprised solely of royal jelly:

"WARNING - THIS PRODUCT IS NOT RECOMMENDED FOR ASTHMA AND ALLERGY SUFFERERS AS IT CAN CAUSE SEVERE ALLERGIC REACTIONS"

Or in the case of a product that contains royal jelly:

"WARNING - THIS PRODUCT CONTAINS ROYAL JELLY AND IS NOT RECOMMENDED FOR ASTHMA AND ALLERGY SUFFERERS AS IT CAN CAUSE SEVERE ALLERGIC REACTIONS"

Or, instead of the above statement, in the case of a product that is comprised solely of royal jelly or a product that contains royal jelly:

"WARNING - THIS PRODUCT CONTAINS ROYAL JELLY WHICH HAS BEEN REPORTED TO CAUSE SEVERE ALLERGIC REACTIONS AND IN RARE CASES. FATALITIES, ESPECIALLY IN' ASTHMA AND ALLERGY SUFFERERS"

For a product containing bee pollen:

"THIS PRODUCT MAY CAUSE SEVERE ALLERGIC REACTIONS"

For a product containing propolis:

"PROPOLIS MAY CAUSE SEVERE ALLERGIC REACTIONS"

Complaint that the food standard offends Standing Orders

The NZCHP argues that the decision to impose mandatory warnings is based on insubstantial scientific evidence and fails to take into account the benefits of bee products. It considers that the labels could be seen by the World Trade Organisation as a technical barrier to trade. It does not object to informing consumers but considers the wording of the labelling has not been justified on the basis of the evidence presented to the ministry. The NZCHP noted that it was not included in the original consultation process.

The NNFA also opposes mandatory warnings being applied to products containing royal jelly, bee pollen, and propolis. It considers that the existing voluntary warnings are informative enough and are widely used. It considers that up to 95 percent of the industry used the voluntary warning labels. It is also concerned about the evidence upon which the decision was based.

The NNFA and the NZCHP (the complainants) argue that the amendment offends five of the grounds set out in Standing Order 197 (2). It argues that the amendment

• is not in accordance with the general objects and intentions of the Food Act 1981 (SO 197(2)(a))

• appears to make some unusual or unexpected use of the powers conferred by the Food Act 1981 (SO 197(2)(c))

• unduly makes the rights and liberties of persons dependent upon administrative decisions which are not subject to review on their merits by judicial or other independent tribunal (SO 197(2)(d))

• was not made in compliance with the particular notice and consultation procedures prescribed by statute (SO 197(2)(h))

• is unreasonable (any other reason concerning its form or purport), and therefore calls for elucidation (SO 197(2)(i)).

Examination of complaint under Standing Order 197(2)

Not in accordance with general objects and intentions of the Act

Risk assessment of bee products

The ministry contends it used risk assessment and risk management principles to develop the discussion document. The document details and discusses the proposed New Zealand food amendment to require a warning statement on all products containing royal jelly, bee pollen, and propolis. The document was issued as a consultation document in November 1997, inviting submissions and supporting data by 16 December.

The ministry stated that its risk assessment process is to

• identify risks for royal jelly, bee pollen, and propolis

• characterise risks (e.g. adverse reactions)

• identify options to manage risk such as legislative or other options.

In its discussion document the ministry relied on reports of adverse reactions from the Centre for Adverse Reactions Monitoring (CARM) in New Zealand. Reporting of adverse reactions to bee products began in November 1993 in New Zealand by CARM and 1991 in Australia by the Adverse Drug Reactions Section (ADRS) of the Therapeutics Goods Administration. The ministry concedes that the numbers recorded by those two organisations are low but considers that because reporting is voluntary adverse reactions are significantly under-reported.

The CARM report comes attached with a document that details the limitations of its reports.

The Centre for Adverse Reactions Monitoring (CARM) has only limited details about each suspected adverse reaction. It is important that the limitations and qualifications which apply to the information and its use are understood. ... The reports submitted to the Centre in many instances describe no more than suspicions which have arisen from observation of an unexpected or unwanted event. In most instances it cannot be proven that a pharmaceutical product or ingredient is the cause of the event.

There have been three deaths in Australia linked to royal jelly in the past five years. An Australian coroner's report (5 June 1997) into the death of a 23 year old woman (3 January 1996) identified royal jelly as the cause of death. Two other deaths have been reported in Australia due to consuming royal jelly and several cases of people with severe asthmatic or allergic reactions. Three cases of adverse reactions involving royal jelly have been reported in New Zealand since November 1993. two of which were severe, indicating life threatening reactions.

The monitoring agencies - the Centre for Adverse Reactions Monitoring (CARM) in New Zealand and the Adverse Drug Reactions Section (ADRS) of the Therapeutic Goods Administration (TGA) in Australia - note that the numbers of reported cases are likely to represent only a small fraction of total adverse reactions.

CARM and ADRS reports show that [the] possibility of adverse reactions to royal jelly products cannot be ruled out in the general population. Therefore, warning statements should include the general population.

The reports clearly show that individuals who have previous history of asthma or allergy are at greater risk of adverse reaction when consuming royal jelly than the general population. This supports statements that emphasise asthma or allergy sufferers are at risk when they consume royal jelly.

The Ministry of Health has also considered the health risks of bee pollen and propolis products. Reports in New Zealand and Australia have linked bee pollen and propolis products to adverse reactions.

Four adverse reactions to bee pollen have been reported to CARM in New Zealand since November 1993.

There is at least one case of an allergic reaction to bee pollen and propolis products where there was no previous history of asthma or allergy. This supports warning statements that apply to the general population [Supra, note 5, pp 9-10]

NNFA raises concerns about the ministry's reliance on the CARM reports. The CARM reporting system is voluntary. It was established to report reactions to medicinal products not foods or dietary supplements. Suspected reactions are reported to CARM and the system of classification appears to be informal, with suspected allergens being noted. The NNFA considers that re-challenges (for example further testing to verify the allergen) with the food product must be carried out before an adverse reaction report can be established as a true allergic reaction to the food product.

The ministry considers that absolute proof of adverse reactions is not readily attainable. It considers that re-challenge tests should not be performed in cases of allergic reactions (anaphylaxis) due to the risk of further severe reaction. The NNFA noted that the CARM report form includes a section to record re-challenges, and that this section is routinely used to record tests for allergenicity, especially in cases where the adverse reaction reported was not of a serious nature.

The NNFA considers that prior to consultation, the ministry had not performed its own literature search. The NNFA bases this comment on the fact that nearly all of the scientific literature that was obtained under the Official Information Act 1982 is date stamped after the preparation of the November 1997 discussion document. It considers that the failure to conduct a literature search is evidence that the ministry did not undertake an independent assessment of the risks of these products, relying solely on the CARM and ADRS reports.

Comparative risk assessment with other foods

The ministry draws a distinction between royal jelly, bee pollen, and propolis products and other foods known to cause adverse reactions because:

many people have not been exposed to these bee products and are unlikely to be aware of the risks they pose and

these bee products are not commonly or traditionally consumed.

The evidence, in the opinion of the NNFA, does not justify the ministry's view that mandatory warning labels on bee products are necessary to protect public health. The ministry considers that adverse reactions reports, medical advice and literature do provide sufficient basis to justify warnings. Much of the evidence including adverse reactions reports and medical advice is unpublished.

Lack of scientific evidence to establish need to protect public health

We received only basic information that the ministry assessed the risk posed by a particular product based on risk assessment principles. We were not provided with any detailed guidelines or internal procedures setting out the ministry's risk management methodology. We cannot, therefore, say that any particular process was followed. We note, however, that the ministry did not challenge the complainants' submission that no risk analysis documents exist for these products. The only evidence the ministry provided in this regard was that the written risk assessment was contained in the discussion document. We consider that this material did not provide a sufficient basis upon which to conclude that there was a need to issue the amendment in order to protect public health.

The ministry used Australian and New Zealand data regarding possible adverse reactions to bee products. The complainant raised concerns about the credibility of those reports. The CARM system appears to operate as a notification system rather than a rigorous monitoring system. It is aimed at the reporting of adverse reactions to medicinal products and is voluntary.

In our view, this reduces the reliability of the CARM system for assessing the risks of bee products.

It appears that the ministry has relied almost entirely on the CARM reports to justify the decision that the public is at risk from bee products. This is despite the Centre itself saying it has only limited details about each suspected adverse reaction, that reports are often no more than suspicions, and that in most instances it cannot be proven that a product or ingredient is the cause of the adverse reaction.

In our view, there is insufficient evidence that the risk assessment undertaken by the ministry justifies the decision to require mandatory warning labels on bee products. We were provided with information that over a two-year period (mid 1995 to mid 1997) that there were 141 hospital admissions to New Zealand hospitals for anaphylactic shock to common foods. The NZCHP submits that according to scientific literature, eight common foods are responsible for 90 percent of allergic food reactions. These foods are milk, egg, wheat, peanuts, soy, nuts, fish and shellfish. The complainants question why the ministry has not taken steps to impose mandatory warning labels on those foods.

In our view, a comparative risk analysis between bee products and other foods containing allergens would have assisted the Minister in assessing the need to protect the public health from risks associated with bee products.

Concluding comments

We conclude that the amendment offends Standing Order 197 (2)(a) because it was not made in accordance with the general objects and intentions of the Act.

Unusual or unexpected use of powers in the Act

Consistency with regulation of other foods

The complainants comment that bee products have been used for centuries. The majority of anaphylaxis cases cause by reactions to foods admitted to hospital were in adults. The complainants consider this negates the ministry's argument that people become aware of common food allergies when young and avoid such foods as adults.

Consistency with international practice

ANZFA is reviewing the need for labelling common food allergens and proposes to require that common food allergens present in food products be declared in the ingredients list. Royal jelly, bee pollen, and propolis are to be included in this review, which was to begin in late April 1999.

Full review of food allergens underway

Voluntary warnings used by 75 to 95 percent of industry

Amendment driven by Australian warnings

For the reasons outlined above we consider that the amendment represents an unusual and unexpected use of the regulation-making power in the Act.

Unduly makes rights and liberties dependent upon administrative decisions not subject to review on their merits

The ministry advised the NNFA that the standard does not allow for alternative wording to be used. The ministry considers that allowing variations in wording to be used could create confusion for consumers. The NNFA was told later by ministry officials that they would not prosecute if different, but similar, wording to that contained in the amendment were used. The NNFA considers this gives ministry officials undue power, as they would arbitrarily be able to decide whether to prosecute.

We do not consider the complainants arguments under this ground of the Standing Orders to be persuasive.

Not made in compliance with consultation procedures prescribed by statute

The NNFA also complains that the parties were not adequately informed so as to be able to make an intelligent and useful response. The NNFA believes that the ministry did not perform a literature search until after the discussion document was published. This is because nearly all of the scientific literature that the NNFA obtained under the Official Information Act 1982 was date stamped after the preparation of the November 1997 discussion document. The NNFA believes that this reduced its ability to make a useful and intelligent response.

The Minister must be satisfied that appropriate consultation has been carried out, as required under section I IE (2) of the Act. Appropriate consultation includes the following

• adequate and appropriate notice to issue a food standard

• a reasonable opportunity for interested parties to make submissions

• adequate consultation and appropriate consideration of submissions.

• obtained data from adverse reactions reporting agencies in Australia and New Zealand and other scientific literature

• prepared a discussion document, using risk assessment and risk management principles

• issued a notice of intention to issue a food standard

• consulted for a period of about eleven weeks, including meetings with industry representatives

• considered the submissions received

• modified the proposal on the basis of submissions and

• made recommendations to the Minister of Health.

Consultation requirements have been considered by the Courts

The Wellington Airport case states that consultation requires the party consulted to be adequately informed so as to be able to make an intelligent or useful response. Also, the party obliged to consult, while entitled to have a working plan in mind, must keep its mind open and be ready to change and even start afresh. We are not satisfied, from the evidence we heard, that the legal requirements of the Wellington Airport case have not been met.

In our view, the complainants' argument that the amendment was not made in accordance with the notification and consultation procedures prescribed by the Act is not made out.

Form and purport unreasonable

In our view the NNFA's arguments do not demonstrate that the amendment offends against Standing Order 197(2)(i).

Associate Minister establishes a review

The group is to advise the Associate Minister on whether

• the precautionary approach to warnings is appropriate

• the quality of evidence that led to the mandatory requirement was adequate

• the quality and extent of the risk assessment and consultation was adequate and appropriate.

We were informed that the group will comprise five food and public health scientists/technical experts. Of the five, two will be from the ministry's Medicines Adverse Reactions Committee, two will be scientists/technical experts acceptable to the bee industry and one will be an independent scientist. We note that the membership of the working group is balanced by the independent scientist who will chair the group.

We were told that the working group is likely to meet in the fourth week of July. We hope the group conducts the review quickly and reports to the Minister as soon as possible.

Because the amendment remains in force it is appropriate for us to report our examination of this complaint to the House.

Our conclusions are that the amendment is not in accordance with the general objects and intentions of the Act and appears to make some unusual or unexpected use of the powers conferred by the statute under which it is made.

Recommendation