Please note that the Food Safety BIM may be accessed at the following website: www.nzfsa.govt.nz/ministers/bim/2007

Subject: BRIEFING FOR THE INCOMING MINISTER FOR FOOD SAFETY

Date: 31 October 2007

Attention: Hon Lianne Dalziel (Minister for Food Safety)

The attached documents have been prepared and collated as a briefing package on the Food Safety Portfolio. The package includes the following documents:
* A structural diagram of the New Zealand Food Safety Authority and a description of each business group
* A summary of key portfolio issues (not in priority order)
* A list (and general description) of legislation administered by the New Zealand Food Safety Authority
* A financial summary of Vote Food Safety and the New Initiative Bids for 2008
* The New Zealand Food Safety Authority Statement of Intent (published in September 2007)
* A profile of the New Zealand Food Safety Authority (published in July 2007).

Sandra Daly
Deputy Chief Executive

NZFSA Organisational Structure: Descriptions

New Zealand Food Safety Authority (NZFSA) is made up of ten business groups under the leadership of the Chief Executive (refer attached diagram). These are:

The Science group provides scientific input into NZFSA's standards for food and food-related products, including risk assessments. The group is a centre of scientific excellence and knowledge of food safety and suitability in both the domestic and international trade contexts. It manages contracts with external science providers and provides international representation on technical issues. Director: Steve Hathaway

The Market Access team negotiates market access conditions and establishes certification requirements with the relevant authorities of countries importing New Zealand's animal and plant products. This includes managing bilateral agreements, trading partner relationships and equivalency negotiations. The team provides strategic and operational input into the export standards and systems and emergencies, as they affect trade and NZFSA's bilateral relationships. Director: Tony Zohrab

The Compliance and Investigation group ensures that standards are enforced, provides justification for export market assurances and undertakes investigations and prosecutions where necessary. Corrective actions and sanctions are also managed. The group complements regulatory controls undertaken by health protection units and local authorities in the domestic arena. Director: Geoff Allen

The Policy group provides policy advice and legal support for NZFSA's review, development, reform, implementation and evaluation of legislation. It is also New Zealand's point of contact with Codex, the international food standards setting agency. Director: Carole Inkster

The Joint Food Standards group provides expert technical advice relating to labelling, nutrition and composition of foods and whole-of-government comments on the work for New Zealand by Food Standards Australia New Zealand (FSANZ), as well as coordinating with the Science group on research for standards development programmes. The group also provides advice in New Zealand on the joint Food Standards Code and relevant New Zealand regulations. Director: Carole Inkster

NZFSA Verification Agency audits the food safety programmes of food processors and provides export certification to some 1200 licence holders who export meat, game and seafood produced under those programmes. It employs veterinarians to inspect animals, ensure animal welfare protocols are followed and provides export certification for the products. NZFSA VA has a staff of over 280 of which 200 are registered and stationed at 80 locations throughout New Zealand, including all meat processing premises. Circuit staff cover smaller processing operations where there is no permanent presence. Director: Steve Gilbert

The Agricultural Compounds & Veterinary Medicines (ACVM) and Approvals group produces and reviews standards relating to agricultural compounds, veterinary medicines and maximum residue limits. It also develops the New Zealand approvals processes under the Animal Products, Wine, Food and ACVM acts. Its role includes maintaining the public registers and lists, and implementing the imported food and food-related products programmes at their point of entry. Director: Debbie Morris

The newly created Standards group is made up of the Export Standards and New Zealand Standards groups. The Export Standards group develops, implements, evaluates and reviews export standards for food and food-related products in New Zealand. It also administers the relevant export components of the APA and Wine acts, manages export programmes that are not covered by legislation and manages all official assurances given for New Zealand food and food-related exports. The New Zealand Standards group develops, implements, evaluates and reviews safety and suitability standards for production, processing, importation, transportation, storage and sale of food and food-related products in New Zealand. It also develops and coordinates implementation of standards, systems and processes for response to food related events and emergencies. Director: Carol Barnao

The Communications and Infrastructure group ensures that NZFSA communicates and consults effectively with all stakeholders and meets their needs for timely, accurate and relevant information. It also ensures that NZFSA has the appropriate human resources, information management, planning and performance systems, and other infrastructure necessary to operate efficiently and effectively. Director: Sandra Daly

The Finance group ensures that NZFSA is adequately resourced and has the appropriate financial advice to ensure its effective and efficient operation. Director: Gary Lewis

Legislation Administered by NZFSA

Agricultural Compounds and Veterinary Medicines Act 1997

The Agricultural Compounds and Veterinary Medicines Act provides for the registration and control of agricultural compounds and veterinary medicines to:

1. prevent or manage risks to;
* public health
* trade in primary produce
* animal welfare
* agricultural security; and
2. ensure that the use of agricultural compounds does not result in breaches of domestic food residue standards.

Agricultural compounds include pesticides, animal remedies, animal feeds, and fertilisers (excluding effluent and animal waste).

Animal Products Act 1999

The Animal Products Act objectives are to:

1. minimise and manage risks to human or animal health arising from the production and processing of animal products; and
2. facilitate the entry of animal material and products into overseas markets.

Animal products include meat, game, fish, poultry and dairy products, and animal
by-products.

Food Act 1981

The Food Act covers all food for sale unless an exemption is given.

The Food Act provides the regulatory platform for the Food Hygiene Regulations 1974 which sets food handling requirements including registration of food premises. These regulations are enforced by local authorities. Food manufacturers may choose to voluntarily register an approved food safety programme with the New Zealand Food Safety Authority. The Food Act provides the regulatory platform for the Australia New Zealand Food Standards Code, which sets joint food labelling and composition standards for New Zealand and Australia. The new Food Bill represents a major revision of the Food Act.

Wine Act 2003

The key objectives of the Wine Act are to:

1. minimise and manage risks to human health arising from the making of wine and the ensuring of compliance with wine standards; and

2. facilitate the entry of wine into overseas markets by providing the controls and mechanisms needed to give and safeguard official assurances issued for the purpose of enabling entry into those markets.

Key Issues Précis

Food Safety Portfolio
Issue Issue Number
Domestic Food Review / Food Bill 1
Market Access 2
Country of origin labelling for food 3
Food fortification 4
Food derived from cloned animals 5
Campylobacter (Campylobacter Strategy) 6
Nutricia 7
Vote Food Safety New Initiative Bids 8
Genetically modified food 9
Safety of Imported Foods 10
A1 and A2 milk 11
Dietary Supplements Review / Supplemented Foods 12
Importation of Raw Milk Cheeses 13
Aspartame 14
ACVM Act Amendments Implementation 15
Wine Act Implementation 16
Antimicrobial Resistance 17
Australia New Zealand relationship in food standard issues 18
Front of Pack labelling 19
Trans fatty acids 20

Issue 1 Domestic Food Review / Food Bill
What is the issue? The Domestic Food Review has been a comprehensive four-year review of how food is sold domestically. The review looked at the current food regulatory regime, which has not been extensively reviewed for over 30 years.

The DFR identified that:
• there is a significant and rising incidence of foodborne illness among the New Zealand population; and
• there were three different food regimes and five separate regulators operating simultaneously, with resulting poor lines of accountability and unnecessary confusion, inconsistency, duplication and complexity
It was the conclusion of the Review that the current food regulatory regime must be improved, and this would require legislative change.
Steps proposed or being taken to address this issue In October 2006 Cabinet agreed to the policy proposals for the drafting of a new Food Bill which will:
• cover the management of the safety and suitability of food;
• apply to all food sold in New Zealand, including imported foods and foods intended for export, whatever its source and whatever the process by which it reaches the point of sale;
• employ a risk based approach to managing food safety and suitability, where possible;
• include the concept of 'persons' (producers, processors, sellers and importers) taking responsibility for producing/processing or providing safe and suitable food.

The agreed policy also allowed for the making of new regulations to replace the current Food Hygiene Regulations 1974; and for the decoupling of some aspects from the Health Act 1956. Additionally there would be minor consequential amendments to assist in the alignment and interface with other food-related primary, secondary and tertiary legislation including the Animal Products Act 1999, the Wine Act 2003 and the Local Government Act 2002.

In developing the new Food Bill it was proposed that the best aspects of the current regime would be retained. Under the Bill, primary responsibility for food safety and suitability would be assigned to individual businesses, rather than businesses relying mainly on the oversight of a regulator to ensure that they deliver safe food.

NZFSA was to seek introduction of the Bill to the House by November 2007, however this has been delayed due to more time being required to develop the draft of the Bill.

Issue 2 Market Access Activities (especially in relation to Free Trade and Bilateral Agreements)
What is the issue? NZFSA is New Zealand's "competent authority" for providing government to government official assurances for food and food related exports, to facilitate New Zealand's overseas food trade. NZFSA also takes a lead role (in conjunction with MFAT and MAF) in developing the sanitary and phytosanitary (SPS) chapters of free trade agreements and in the development of food trade related bilateral agreements and arrangements.
Maintaining and enhancing New Zealand's access to export markets requires constant focus and effort.

Steps proposed or being taken to address this issue NZFSA has a comprehensive programme of market access activities focussed on overseas government relationships. This is underpinned by E-cert, an electronic, web-based certification system developed by New Zealand that facilitates export documentation.
There is a particular focus by New Zealand on "trade as a two way street". By this is meant we need to be focussed on balancing, wherever possible, our import and export trade activities whilst ensuring New Zealand's food safety record in human and animal health is clearly addressed.

Issue 3 Country of Origin Labelling for Food
What is the issue? Over the last 18 months there has been sustained and apparently increasing consumer and media interest in the issue of mandatory country of origin labelling for food. Such a policy is inconsistent with that of successive New Zealand Government's, which have favoured voluntary CoOL to be used by industry in response to consumer demand as need be.

Interest in CoOL has been generated and maintained by various events, these being:
The 'food miles' debate that is ostensibly based on concerns about sustainable and 'small footprint' food production and environmentally conscious food choices;
Publicity around the Consumers Right to Know (Food Information) Bill which was introduced by Sue Kedgley as a Private Members Bill in May 2006 (the Bill did not pass First Reading);
Concerns about the safety of some imported food being sold in New Zealand (not supported by NZFSA testing programmes); and
An interest among consumers in supporting local product and domestic food producers.

Sue Kedgley MP has been circulating a petition calling for mandatory CoOL for fresh and whole produce (fruit, vegetables and meat) which is intended to be presented to Parliament in or about the second week of November 2007.

The Minister for Food Safety may be asked to consider the Government position on CoOL, in light of enduring consumer interest in the issue. The presentation of the CoOL petition (which could be referred to a Select Committee for consideration and public submissions) may also increase exposure of this issue.

Steps proposed or being taken to address this issue In October 2005 the Government made the decision to opt out of a proposed standard on mandatory CoOL for food. The reasons included: cost to consumers and industry, flexibility for destination market if labelling not mandated and the high prospect of New Zealand processed foods including ingredients from other countries (posing practical difficulties in deciding country of origin for labelling purposes). As a food exporter, New Zealand needs as much flexibility as possible for marketing our food and that applies to both domestic and export markets.

New Zealand's position internationally on CoOL is entirely consistent with our domestic position – that CoOL is a commercial and trade matter and we will oppose it being mandated on imported products wherever we can.

CoOL is NOT a food safety issue – it is a commercial decision for consumer information purposes only. If food manufacturers considered they could get market advantage by labelling product as 'product of New Zealand' for the domestic market then they are free to do so.

There are mandatory CoOL requirements in New Zealand – foot wear and clothing (a carry over from high tariff times) and wine (currently a transitional standard in the joint Australia New Zealand Food Standards Code). This standard is currently under review.

Country of origin information is regulated in New Zealand by the Fair Trading Act which regulates misleading and deceptive labelling. The Fair Trading Act does not require all products to be labelled with a place of origin but where it is so labelled, the information on a product must be truthful.

NZFSA does not consider there to be strong grounds for revising the existing Government policy on CoOL for all food, particularly given that voluntary CoOL programmes for whole foods (fruit, vegetables, meat and whole fish) have been introduced in New Zealand's two largest supermarket chains – Progressive Enterprises and Foodstuffs.

Issue 4 Food Fortification
What is the issue? The addition of essential vitamins and minerals to food, known as food fortification, has occurred in New Zealand since the beginning of the 20th century (the first fortification being the addition of iodine to salt). Mandatory fortification is only considered in New Zealand and internationally, as a means to address a significant public health issue where other methods have failed, would be unlikely to succeed or would not be appropriate.

The last few years have seen increased permissions for the voluntary addition of vitamins and minerals to some foods. These permissions have been carefully developed by Food Standards Australia New Zealand (FSANZ) to ensure the safety of the food supply and only moderate amounts of permitted nutrients may be added to foods.

There have been two recent developments in the area of food fortification. One of these, the fortification of bread with folic acid, came into effect in New Zealand on 25 October 2007 (refer details below), and the other, the addition of iodised salt to bread is under consideration by FSANZ.

Some consumers take issue with food fortification. The grounds for opposition include: perceived removal of choice for those who do not want to consume the vehicle food in a fortified state; concerns about 'over exposure' for those who eat large quantities of the vehicle food, philosophical aversion to the imposed 'medicalisation' of the food, and aversion to the entire population being exposed to an intervention targeted to a particular population sector (for example folate fortification).
Steps proposed or being taken to address this issue The process for considering and introducing a particular fortification involves extensive consultation and consideration of all issues including the effect on consumer choice, the potential effectiveness of the fortification balanced against any potential risks and, taking into account all relevant factors, the most appropriate food vehicle.
Folate Fortification
Mandatory fortification of bread (excluding organic and unleavened bread) with folic acid is a public health initiative being employed to reduce the incidence of neural tube defects (NDTs), the most common of which is spina bifida. Currently, it is estimated that each year in New Zealand there are 70 NTD affected pregnancies, and the folate fortification measure is expected to redice that number to between 4 and 14.

The food standard for mandatory fortification of bread with folic acid came into effect on 25 October 2007. There is a two year period within which all commercial bread makers must be compliant with the standard, and two years after the transition period ends there will be a comprehensive independent review of the standard.

Iodine Fortification
A proposal recommending the addition of iodised salt to bread has been prepared by FSANZ and is expected to be considered by the Australia and New Zealand Food Regulation Ministerial Council in 2007.

New Zealand has a population-wide problem of iodine deficiency and it is currently difficult for most consumers to obtain adequate iodine from their normal diet. Iodine deficiency in the general population is attributed to several factors, these being: increased consumption of commercially prepared foods (usually made with non-iodised salt); the low iodine levels in New Zealand soils (thus low levels in New Zealand produce); and less salt being used in home cooking because of messages about reducing salt intake.

Vitamin D
Currently, vitamin D is allowed to be added to some foods in New Zealand and Australia – namely lower fat milk products – and is a mandatory addition to margarine in Australia only. It is expected that review of these permissions will occur in both countries. Vitamin D is essential in promoting calcium absorption and is hence involved in the development and maintenance of healthy bones. Vitamin D is produced in the body by the action of UV radiation but is also available in a limited number of foods. Preliminary data would suggest that there may be an issue with inadequate vitamin D intake among some New Zealanders, especially in the winter months, when there is reduced sunlight. NZFSA and the Ministry of Health have commissioned a review of the literature in this area to support any review of vitamin D fortification.

Issue 5 Food Derived from Cloned Animals

What is the issue? The successful cloning of livestock, and the possibility that cloned animals could in future enter the human food chain, has required that consideration be given to a policy position on food derived from cloned animals. Such a position, while not to date applied, is needed to provide consumers and industry with clarity on how Government will respond to the issue if it arises.
Steps proposed or being taken to address this issue In September 2006 Cabinet agreed to adopt a Government Policy Position on Food Derived from Cloned Animals & their Offspring

The policy position was not broadly communicated as there was no proposal to regulate and the subject matter is of a highly technical nature. If regulation is required full public consultation would need to be undertaken.

The policy position (which is on the NZFSA website) notes:
• that there is no evidence suggesting food derived from healthy cloned animals constitutes a risk to consumers;
• that should food derived from cloned animals or their offspring ever enter the food chain, there is no need for specific regulation as these foods would be subject to general safety requirements under existing legislation;
• that NZFSA will continue to monitor and evaluate new scientific information regarding the safety of food derived from cloned animals and any international developments.

The policy position also acknowledges that the cloning procedure can have negative effects on the health of some cloned animals. Such unintended effects are not unique to cloning and a number of investigations have shown that these abnormalities are not passed on to sexually reproduced offspring.

In New Zealand the cloning of livestock animals is still at the experimental stage and is restricted to very small numbers of elite breeding stock. All cloned animals are currently confined to the research environment or in rare instances are held externally under a formal arrangement that removes the prospect of the animal or offspring being presented to a slaughter premises.

The costs associated with cloning technology mean that the commercial application of cloning will continue to focus on high value breeding stock rather than animals destined for the food chain.

Issue 6 Campylobacter Strategy

What is the issue? Campylobacter is a bacterial organism that causes the gastrointestinal disease campylobacteriosis when it lodges in the walls of the intestine. The two species that affect most people in New Zealand are Campylobacter jejuni and Campylobacter coli.
The disease is a key public health concern in New Zealand because:
• the rate of confirmed cases that are reported to public health units is higher than that of any other reported gastrointestinal illness
• it is the largest contributor to the economic costs of foodborne diseases.
Since first being made a notifiable disease in 1980, reported incidences of Campylobacter have risen fairly steadily. Over the past five years the rate has increased at about 12% per year.
The rate of notified campylobacteriosis cases in New Zealand is relatively high (370 per 100,000) compared to other developed countries (for example, 82 per 100,000 in the UK; 122 per 100,000 in Australia – excluding New South Wales) but such comparisons need to be treated with caution because of the varied reporting systems that different countries may use.
Nevertheless, NZFSA acknowledges that New Zealand's rates of human illness associated with Campylobacter are unacceptably high.

Steps proposed or being taken to address this issue NZFSA launched the 'Campylobacter in Poultry Risk Management Strategy 2006-2009' on 30 November 2006. The Strategy identifies that work relating to Campylobacter occurs under six main work streams:
• development and implementation of monitoring and surveillance activities;
• development and implementation of hazard based controls;
• development and implementation of risk based controls;
• risk communication;
• international collaboration; and
• other stakeholders.

Overall implementation of the Strategy is on target, albeit with tight timelines, and individual companies within the poultry industry, through the Poultry Industry Association of New Zealand (PIANZ), have been very cooperative in assisting NZFSA so far. Quarterly meetings have been held with PIANZ to further facilitate co-operation.
The main area in which progress has not been made involves the industry-led industrial-scale trials of Campylobacter decontamination processes at an operational poultry processing premise.

Due to a fire at the original trial site over the Christmas 2006 holiday period, further trial work at that premise has been delayed until now. NZFSA is also in contact with a number of poultry companies trialling other intervention options and discussing those that could be trialled.

Notable developments include:
• continuing progress in the collaborative work with Massey University and MidCentral Public Health in the Manawatu on determining the actual source of Campylobacter infection in individual cases;
• the establishment of the National Microbiological Database (NMD) monitoring scheme for Campylobacter;
• the development of an Inter-Laboratory Comparison Programme (ILCP) to ensure nationwide consistency of laboratory analysis for Campylobacter ;
• development of a "Broiler Growers Manual" by PIANZ, with input from NZFSA;
• development by NZFSA of a draft code of practice for processing poultry and commencement of discussion with industry;
• research into packaging and retail arrangements for poultry products;
• development of a risk model to assist in determining the effectiveness of antimicrobial interventions; and
• fruitful discussions at the international level on what other countries are doing to address Campylobacter and the commencement of work by a working group to the Codex Food Hygiene Committee (being jointly lead by New Zealand and Sweden) on development of an international standard.

Regular updates on progress are provided on the NZFSA website.

In April 2007, it was announced that NZFSA and the Ministry for the Environment have been awarded $735,000 over the next three years from MoRST to help further research into Campylobacter. The two organisations will work together to administer that research which will enable scientists from several New Zealand research providers to investigate how Campylobacter behaves in the food chain and the environment.

Issue 7 Nutricia

What is the issue?
Nutricia Limited manufactured Karicare Gold Plus infant formulas and Karicare Nutriprem Gold Plus Ready-to-Feed Pre-term Formula which contained the sugars fructo-oligosaccharides (FOS) and inulin, in contravention to the Australia New Zealand Food Standards Code (Code).

The non-compliant product was available for sale between January 2007 and October 2007. FOS and inulin were determined by NZFSA to be nutritive substances as defined in the Code, and which require specific permission in the Code before being added to infant formula products.

Infant formula is the principal source of nourishment for infants. Compliance with the Code is essential for minimising risk to vulnerable consumers and for ensuring a robust regulatory system for food products in general. FOS and inulin were intentionally added to the Nutricia products for a prebiotic purpose, but have not undergone a risk assessment in keeping with the application process to approve these substances as nutritive substances in the Code.

Steps proposed or being taken to address this issue
NZFSA considers that Nutricia has incorrectly applied the classification of FOS and inulin as nutritive substances in the Code. NZFSA is taking a cautionary approach to this issue until it has had an opportunity to fully assess all safety implications associated with the inclusion of FOS in infant formula products under New Zealand conditions.

NZFSA released a statement from the Director-General in July 2007 advising the public that these products were non-compliant with the Code but did not at that time recall any product. In order to confirm our interpretation of the relevant provisions of the Code we have filed a statement of claim in the High Court seeking declarations from the court to clarify certain questions of interpretation.

Nutricia has reformulated and made available for sale (as of September 2007) certain products from their Karicare Gold Plus range which omits FOS and inulin from the ingredients list. Depending on the outcome of the Declaratory Judgment proceedings NZFSA will assess whether any further action is justified.

Issue 8 Vote Food Safety New Initiative Bids

What is the issue? Two New Initiative Bids have been prepared as part of the 2008 Budget round. This information is Budget Secret and is provided in an attachment to this document (Refer: Vote Food Safety Financial Information).
Steps proposed or being taken to address this issue n/a Refer above

Issue 9 Genetically Modified Food

What is the issue? GM food ingredients can only be sold in New Zealand if Food Standards Australia New Zealand (FSANZ) has assessed them for safety and they have been approved by the FSANZ Board and cleared by the Australia and New Zealand Food Regulation Ministerial Council. Any individual or organisation, whether from New Zealand, Australia or any other country, may make an application to FSANZ seeking to change the Food Standards Code.

The FSANZ approval process is open and consultative, with comments being sought from all stakeholders at least once during the assessment process. This system allows stakeholders to raise relevant issues that are then specifically addressed in assessment reports.

As part of the open and transparent system operated by FSANZ, all information and data relating to a GM food is accessible via a public register file. An exception to this occurs only when certain information is given confidential business information status by FSANZ.

Currently 32 GM food ingredients have been approved through the FSANZ process.

Notwithstanding the FSANZ assessment processes, and available science indicating that GM varieties are as safe as their conventional counterparts, there is some public concern about the safety or appropriateness of GM foods.

Several issues have arisen over the last year in respect to two GM foods; one of which (MON863) has been approved for use in food sold in New Zealand, and the other (LY038) which awaits a decision by the Minister for Food Safety.

Steps proposed or being taken to address this issue
MON863 Corn
In December 2002 Monsanto applied to FSANZ to approve food from MON863 corn. This approval came into effect in New Zealand in April 2004. In March 2007 NZFSA became aware of a study, conducted by the CRIIGEN research group, claiming to have found differences indicating liver and kidney toxicity in rats fed MON863 corn. This study was commissioned by Greenpeace and involved the statistical
re-analysis of a 90-day rat feeding study, which was published by Monsanto in June 2005.

NZFSA's resident toxicologist reviewed the study and came to the initial opinion that the re-analysis by the CRIIGEN research group confirmed the original findings of FSANZ and other regulatory authorities, that MON863 corn poses no greater risk to consumers than non-genetically modified corn.

NZFSA sought independent advice from the ESR on the data from the Monsanto 90-day rat feeding study and the CRIIGEN study (the statistical re-analysis of the former). A briefing on the ESR advice, and the outcome of reviews conducted by FSANZ and the European Food Safety Authority will be provided to the Minister for Food Safety in the near future.

LY038 Corn
FSANZ assessed an application (A549) from Monsanto to approve to the sale and use of food derived from high lysine corn (LY038). High lysine corn has been produced as an animal feed, but must be assessed for food safety under a MoU between FSANZ and the Office of the Gene Technology Regulator (Australian). A food safety assessment is considered necessary because of the possibility of LY038 accidentally entering the human food chain. The application proceeded through to a final assessment report which recommended an amendment to Standard 1.5.2 of the Australia New Zealand Food Standards Code to give approval to the sale and use LY038 corn.

When the Australia New Zealand Food Regulation Ministerial Council considered the recommendations of the FSANZ final assessment report on A549, the Minister for Food Safety requested a review on the grounds that approval of the application would not promote consistency between domestic and international food standards where these are at variance.

During the assessment of LY038 corn, concerns were raised by several stakeholders regarding the safety of LY038 corn. NZFSA did not share these concerns and believed that these were adequately addressed by FSANZ in the Final Assessment Report. FSANZ completed the First Review of A549, and re-affirmed its approval of the draft variation to Standard 1.5.2. of the Code to allow the sale of food derived from high lysine corn line LY038. In August 2007, ANZFRMC considered and accepted the FSANZ First Review report and the approval of the draft variation.

In order to give effect in New Zealand to a new or amended food standard, the standard must be publicly notified for 28 days (published in the New Zealand Gazette). The Minister for Food Safety made the decision in early August 2007 to delay Gazettal of the standard until such time as she was satisfied that food standards amendments for varieties intended as animal feed are within the scope of the joint food standards setting system.

The Minister has indicated that a decision on whether to give effect to the standard in New Zealand will be made following receipt of advice on that issue from NZFSA.

Issue 10
Safety of Imported Foods

What is the issue? Imported food now constitutes 20% (by value) of food consumed in New Zealand. A 2004 external review of the imported food programme concluded that although there where no urgent or serious public health risks with the current programme, several improvements could be made. Internationally, 'food scares' have increased consumer concerns about the safety of foods produced in certain countries, most recently these have been related to foods from China. In New Zealand this had led to calls from consumer groups and the Green Party for increased monitoring and/or testing of all imported foods, as well as being linked to calls for country of origin labelling (refer Issue 3 above)

Steps proposed or being taken to address this issue None of NZFSA's range of testing programmes to date has found any serious issues with levels of residues in foods imported into New Zealand from China. NZFSA's testing and surveillance programmes show produce available in New Zealand, both imported and domestically produced, has extremely low levels of chemical residues. NZFSA has strong links with its international counterparts and remains on alert for issues that may impact on New Zealand. In cases where there have been incidents overseas, NZFSA's relationship with international counterparts has given no cause to suspect that the affected foods have been sold in New Zealand.

NZFSA emphasise that monitoring / testing of all imported food is however, a costly and inefficient method for providing the assurance that products meet a particular standard. NZFSA strives to provide international leadership in terms of taking a science and risk based approach to regulation and under the new Programme there is a shift away from relying primarily on controls at the New Zealand border to manage the safety and suitability of imported foods to a system that recognises controls in place overseas to ensure they meet or are equivalent to New Zealand's standards for domestic food.

Proposals to implement recommendations from the Imported Food Review were agreed by Cabinet in the 'Blueprint for Change'. The new Programme is designed to be responsive, flexible and ensure controls on imported food are effective, efficient and based on a sound risk management decision making framework. Increased monitoring will occur for certain imported foods e.g. farmed fish / crustacean, Roquefort cheese.
NZFSA has outlined proposed changes to the import programme (some of which are subject to passage of Food Bill). In summary these are:
* Categorisation of imported foods into high medium and low levels of regulatory interest
* Differential risk management based on categorisation
* "Scanning" of certain products (i.e. increased monitoring) which will monitor compliance of imported food and associated overseas systems, identify emerging issues / intelligence gathering and includes specific programmes e.g. Food Residue Surveillance Programme. It also permits additional temporary monitoring measures to immediately be put in place when risks are identified or when gaps in our knowledge arise, irrespective of the categorisation of that food.
* Registration of all importers.

Issue 11 A1 and A2 Milk

What is the issue? Cow's milk contains six major proteins the most common of which are beta-casein A1 and beta-casein A2. Milk high in beta-casein A1 is referred to as 'A1 milk' while milk high in beta-casein A2 is called 'A2 milk'.
Research published in 2004 in the New Zealand Medical Journal suggested a possible link between milk protein consumption and heart disease and insulin-dependent diabetes. Researchers Dr Murray Laugeson and Professor Emeritus Bob Elliott collected data from various sources from 20 wealthy countries and reported a significant correlation between the amount of A1 beta-casein consumed in a country and the national rate of coronary heart disease. They also found a similar correlation between A1 beta-casein consumption and the rate of childhood type 1 diabetes.
In response, 2004, NZFSA commissioned an independent review of the science on A1 and A2 milk, on the basis of which NZFSA maintained the position that there is insufficient evidence to suggest any change to advice that milk is a safe and nutritional part of the diet.
In September 2007, Professor Keith Woodford published a book "The Devil in the Milk" refuting the NZFSA position on the A1/A2 milk issue and suggesting that the Authority did not give due consideration to the recommendations made in the 2004 report. A short time thereafter, the report's author Boyd Swinburn publicly criticised NZFSA for it's response to his 2004 report.
The A1/A2 debate is therefore in part about the science and about the decision making process of NZFSA in respect to this issue.

Steps proposed or being taken to address this issue
On 10 October 2007, NZFSA announced reviews into the A1/A2 milk claims made by Professor Keith Woodford. The reviews will cover both science available on A1 and A2 milk and the process by which NZFSA came to the decision in 2004 to continue to take the position that all milk is safe.

The reviews will be commissioned by NZFSA and the terms of reference and choice of reviewer will be confirmed by the Minister for Food Safety.

There is likely to be close scrutiny of the review (particularly by industry sectors, and academics holding views on the issue) and NZFSA will take the approach of public updates on the process, timeframes and outcomes (recommendations).

It is anticipated that the terms of reference and the credentials of the chosen reviewer will be ready for the Minister's consideration during November 2007.

Issue 12 Dietary Supplements Review / Supplemented Foods

What is the issue? In New Zealand dietary supplements are regulated under the Dietary Supplements Regulations 1985 (the Regulations), which operate under the Food Act 1981.

The Regulations were originally intended to cover products that were not food in use, appearance or presentation, but nor were they medicines in the generally accepted sense. When the Regulations were promulgated, the Ministry of Health was responsible for the administration of the Food Act. The Food Act and its regulations are now administered by NZFSA.

The range of products sold under the Regulations has expanded significantly over the last 20 years, to the point at which there are now many dietary supplements in tablet, capsule or powder form that are being used for therapeutic purposes.

The range of products has also expanded to include foods such as drinks and health bars with vitamins, minerals and other substances added to provide a "health" benefit.

Provisions within the Regulations have, for some time, been recognised as inadequate to regulate this large and growing range of products.

Steps proposed or being taken to address this issue NZFSA has conducted two rounds of public consultation on a proposal to divide products currently sold under the Regulations into food-type and therapeutic-type dietary supplements. This proposal has wide support from regulators, industry and consumers.

Cabinet has also agreed to the proposal and has invited the Minister for Food Safety to issue drafting instructions to the Parliamentary Counsel Office for the necessary amendments to the Regulations. The amendments will include:
• the exclusion of food-type dietary supplements from coverage under the Regulations;
• a requirement for products sold under the Regulations to be registered on a database maintained by the Ministry of Health; and
• the transfer of administrative responsibility for the Regulations to the Ministry of Health.

The regulation of food-type dietary supplements will subsequently be achieved through the mechanism of a standard under the Food Act. This standard, the Supplemented Food Standard, is currently being developed by NZFSA for your consideration, and if you agree, issue.

Issue 13 Importation of Raw Milk Cheeses

What is the issue?
Currently, only limited varieties of cheeses made from raw milk can be imported and sold in New Zealand, following case-by-case assessments of the risk that they pose to consumers. All other imported and locally manufactured dairy products must be pasteurised or thermised. However, in other parts of the world there is a culinary tradition of raw milk products and such products are widely available.

NZFSA has received requests to allow more raw milk products, especially cheeses, to be imported and to develop a regulatory framework to enable domestic manufacture and local sale of raw milk products. These requests have come mainly from advocates of consumer choice, importers, some local manufacturers and the French Government.

Balanced against the requests for a more liberal regulatory framework are concerns that, because raw milk products can contain listeria and E coli bacteria, they pose risks to the young, old, pregnant and immuno-compromised (YOPI) sector of the population (i.e. the young, elderly, pregnant and those immuno-compromised by illness or surgical treatments).

A further complication is that, in September 2005, the Australian Government decided to allow the importation and sale of Roquefort cheese, a raw milk cheese. Under the Trans Tasman Mutual Recognition Arrangementt (TTMRA) products that can be sold in Australia can also be sold in New Zealand. In practice, this has meant that small quantities of Roquefort have been imported via Australia and sold in New Zealand since this time.

Steps proposed or being taken to address this issue After public consultation, the New Zealand (Milk and Milk Product Processing) Food Standard 2007 was introduced to allow for the direct importation of Roquefort. This regularised the existing de-facto situation of Roquefort cheese entering New Zealand from Australia under the TTMRA. The Standard was introduced after a qualitative risk assessment by NZFSA recommending that, provided appropriate risk management measures are undertaken, the importation of Roquefort should be allowed. These measures include 100% verification of import certificates that the relevant EC standards, (similar to those for the manufacture of New Zealand cheese) have been met, ongoing monitoring of imports to check for E coli levels and an expanded education programme for YOPI groups.

NZFSA is now undertaking further work into the development of requirements for the importation and manufacture of raw milk products. The aim is to have regulatory framework in place by October 2008 to allow raw milk cheeses and other raw milk products to be produced within New Zealand and for a greater range of such products to be imported. This will satisfy consumer demands, the issue of inequities between importers and local manufacturers and NZFSA's obligations to meet international trade laws.

Issue 14 Aspartame (artificial sweetener)

What is the issue? Aspartame is the common name for an intense artificial sweetener used in many sugar-free and 'diet' food products.

There is a long-running controversy regarding the approval of aspartame for use in food products. Opponents of aspartame cite anecdotal evidence that its consumption can result in a number of minor and serious health disorders including cancer.

Large scale international studies have not found evidence to support this hypothesis. For example, a 2002 review of over 500 pieces of research on aspartame carried out by the European Commission's Scientific Committee on Food (SCF) concluded that the additive was safe and that the established acceptable daily intake was appropriate.

In July this year a New Zealand case of 'aspartame poisoning' was widely reported in the media. Wellington woman Abby Cormack reported that the physical and psychological symptoms she was suffering ceased after she stopped consuming sugar-free chewing gum containing aspartame. Ms Cormack had been consuming, on average, four packets of chewing gum per day for eight months.

Steps proposed or being taken to address the issue Aspartame is approved for use in food under Standard 1.3.1 Food Additives of the Food Standards Code. FSANZ keeps a watching brief on new research regarding food additives including aspartame. NZFSA monitors significant new research on food additives and reviews any recommendations made by FSANZ.

The Food Standards Code requires all additives contained in a food product to be labelled by additive type (preservative, flavour enhancer, sweetener) and additive number. In addition to this standard requirement, products containing aspartame must also explicitly state that the product contains phenylalanine. Phenylalanine is one of the constituent amino acids in aspartame. A small group of people cannot safely consume phenylalanine. This group includes those with the inherited disease phenylketonuria (PKU) and pregnant women with high blood levels of phenylalanine.

The NZFSA website hosts a page with detailed information about current research on aspartame and information about the labelling requirements for foods containing aspartame. Consumers wishing to avoid aspartame are advised to look for the explicit phenylalanine statement on the label of foods containing aspartame.

In response to the Abby Cormack case NZFSA stated that the agency cannot usefully comment on individual cases. NZFSA also cited the considerable volume of research that indicates there to be very little or no risk to human health from aspartame consumption if that consumption is below the Acceptable Daily Intake set by the Joint World Health Organisation and Food and Agriculture Organisations' Expert Committee on Food Additives.

Issue 15 ACVM Act Amendments Implementation

What is the issue? An amendment to the Agricultural Compounds and Veterinary Medicines Act (ACVM) 1997 was passed by Parliament in October 2007. The key amendments are: increased coverage of the Act – including that risks to Public Health are managed under the Act, and that all parts of the supply chain can be regulated; the inclusion of a specific statement on the Scheme of the Act and its relationship to other legislation including the Hazardous Substances and New Organisms Act; restructure of the way in which the sector is regulated by providing for setting of standards by regulation rather than codes of practice and for the Director-General (Chief Executive of NZFSA) to make notices; and the ability to exempt agricultural compounds from registration in specified special circumstances. The amendment provisions of the Act came into effect on Royal Assent however, NZFSA expects the immigration of standards into regulations to occur over the next 10 – 12 months.

In addition, NZFSA is reviewing a number of key operational interpretations in the ACVM Act including revising the thresholds and criteria for active or passive management of risks under the Act. A key implication of this review process is the potential to include a number of agricultural compounds originally excluded from the scope of the Act, however such inclusion is not expected to mean active regulation will be required for all such products.

Steps proposed or being taken to address this issue
NZFSA has established an implementation project team to oversee the transition. First steps include the release of a discussion document on the ACVM Act Regulatory Framework and Operational Interpretations, this is currently planned for later this year (once approval from the Minister for Food Safety is received). NZFSA communications strategy includes NZFSA holding a series of stakeholder meetings, particularly for those stakeholders whose products are currently not covered in the scope of the Act, to introduce and outline the matters set out in the discussion document. Once consultation on the regulatory framework and operational interpretation is completed NZFSA intends to consult with stakeholders on the proposed new regulations (standards) and guidelines for administration of the Act.

Issue 16 Wine Act Implementation

What is the issue? The Wine Act commenced on 1 January 2004, and will be fully implemented by 1 December 2008. The Act requires all winemakers to operate under a wine standards management plan by 1 December 2008. A wine standards management plan is a document that demonstrates how the winemaker will meet the standards and requirements of the Act. Compliance with the wine standards management plans will be verified by independent third parties recognised by the NZFSA.

The key issue that arises from the implementation of the Wine Act is the one of managing regulatory burden. Up until now, the wine industry has had little exposure to food-related regulation, and the standards and requirements of the Act are relatively new concepts to the industry. Any new regulation imposes direct and indirect costs, and coming into the new wine regulatory system does represent significant change for a number of wine businesses.

Steps proposed or being taken to address this issue NZFSA has taken a partnership approach with the wine industry and developed simple, practical wine standards that manage risks to food safety, wine identity and truthful labelling. NZFSA and industry have jointly developed a wine standards management plan Code of Practice, which will significantly reduce the cost of compliance upon winemakers. Free training workshops on these will be held after next year's vintage. NZFSA is proposing to exempt very small winemakers (who only sell their wine on the domestic market) from the requirement to have a wine standards management plan (this would not exempt them from compliance with other requirements in the Act). NZFSA is currently streamlining the transition into the verification system for the independent third parties and will be running free training workshops for these parties in February next year.

While it is likely that some winemakers will find moving into a new regulatory regime challenging, a significant amount of work has gone into developing sensible, focussed regulation and providing tools to assist compliance. At the same time, NZFSA has also worked to ensure a system that is robust and credible.

Issue 17 Antimicrobial Resistance

What is the issue? The use of antimicrobial/antibiotic products for the treatment or prevention of plant and animal diseases can lead to the development of antimicrobial/antibiotic resistance in humans if these products contain the same compounds as those that are used to treat or prevent human illness.

Steps proposed or being taken to address this issue NZFSA established an Antibiotic Resistance Steering Group in 2004. An Expert Panel was set up and reported to the Steering Group in 2005. The recommendations from the Expert Panel were considered by the Steering Group which subsequently made recommendations to NZFSA. These recommendations included that an Antimicrobial Resistance in Animals Surveillance Programmes be established; it also made specific recommendations on particular groups of drugs including a review of registrations on amino-glycosides (eg streptomycin) in both animals and plants; and the establishment of an Expert Technical Advisory Group to advise on antimicrobial issues, including registrations. Internationally the World Health Organization, Food and Agriculture Organization and the OIE (the international animal health organisation) have all been working on the issue of antimicrobial resistance. The Codex Alimentarius Commission (the joint FAO / WHO int
ernational food standards setting body) has recently established an Ad Hoc Taskforce on Antimicrobial Resistance which is intended to build on the work of WHO, FAO and OIE.

The recent amendment of the ACVM Act (refer second listed awareness issue) also provides a clear legislative mandate for the management of antimicrobial resistance in that risks to public health are now specified in the Act. NZFSA has reviewed the streptomycin products for veterinary medicines and advised holders of current registrations they will either need to change the registered uses of these products or cancel the registrations. The one horticultural based streptomycin is shortly to be reviewed. The intention is to ensure that unnecessary use of these products as veterinary medicines and horticultural applications does not occur. A proposal for a surveillance programme for Antimicrobial Resistance in Animals is being developed, but decisions on implementation and funding are yet to be made. NZFSA is continuing discussions with the Ministry of Health on the establishment of the Expert Technical Advisory Group. The Codex Ad Hoc Taskforce on Antimicrobial Resistance h
eld its first meeting 22-26 October 2007 and New Zealand was represented by NZFSA.

Issue 18 Australia – New Zealand Relationship in food standards issues

What is the issue? A review of the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System (the Food Treaty) was conducted in 2005 as required by Article 9 of the Treaty. During the course of that review issues were identified as needing consideration in terms of potential Treaty amendments.

Additionally, the Food Standards Australia New Zealand (FSANZ) Act was amended in July 2007. Amendments regarding FSANZ processes cannot be enacted until relevant amendments have been made to the Treaty.

Steps proposed or being taken to address this issue. In October 2007, Senator Brett Mason, the Australian Commonwealth Minister responsible for food regulation, wrote to the New Zealand Minister for Food Safety formally closing the review and proposing that officials commence negotiations on necessary amendments to the Treaty. The New Zealand Minister for Food Safety responded to Senator Mason's letter agreeing that negotiations should commence.

Issue 19 Front of Pack Labelling

What is the issue? There have been claims that current labelling practices confuse consumers and do not achieve the aim of providing them with an understanding of the nutrition and energy value of foods they plan to purchase.

Recently a few Australian and New Zealand food manufacturers have introduced various voluntary front-of-pack labelling systems including the percent daily intake (%DI) labelling scheme. Overseas, a number of front of pack (FOP) labelling systems are used voluntarily, including systems similar to the %DI system, a 'traffic light' labelling scheme in the United Kingdom promoted by the UK Food Standards Agency and a 'keyhole' system used in Sweden.

There has been increased media coverage regarding whether a uniform food labelling system should be implemented in Australia and New Zealand to help consumers make informed and healthier choices about the food they eat in order to combat the various health issues including the growing problem of obesity.

In New Zealand the Health Select Committee has recommended 'that a traffic light or comparable system for food labelling be developed'.

The issue of FOP labelling was brought to the attention of Ministers at the Australia and New Zealand Food Regulation Ministerial Council meeting in October 2006. Ministers requested that the Food Regulation Standing Committee (FRSC) explore whether a uniform front of pack labelling system would be an effective health strategy, and to advise on the efficacy of a range of options for such a labelling system.

Steps proposed or being taken to address this issue. FRSC has convened a working group to explore and report back to the Ministerial Council whether a uniform FOP food labelling system would be an effective health strategy, and to advise on the efficacy of a range of options for such a labelling system. The working group consists of representatives of the States and Territories of Australia and New Zealand. It is expected that options will be presented to the Ministerial Council in October 2008.

NZFSA, along with the Ministry of Health, is currently part-funding research into FOP labelling commissioned by the Health Research Council which will look at the following: evidence on consumer food purchasing decisions; whether a FOP labelling system would be likely to improve decision-making of the consumer in relation to the purchase of healthier foods in New Zealand; stakeholders' views on the implementation of FOP labelling in New Zealand and the feasibility of an FOP labelling supermarket intervention study. This will be some of the first work looking at the use of FOP labelling by consumers in a real supermarket setting, and will help to fill a research gap in this area.

Issue 20 Trans Fatty Acids

What is the issue? Trans fats are a type of unsaturated fatty acid, but unlike most other unsaturated fatty acids have negative health effects on blood cholesterol that are similar to saturated fatty acids. Dietary intake of saturated and trans fatty acids strongly influences the risk of coronary heart disease thorugh the effects on total cholesterol, blood pressure and atherosclerosis.
The majority of trans fats in the diet are from manufacture red foods made with partially hydrogenated oils such as crackers, biscuits, donuts and pastries. Trans fats also occur naturally in products from ruminant animals such as cows and sheep.

Trans fatty acids and saturated fatty acids should comprise of no more that 10% of total energy intake, however saturated fats alone provide 15.3% of total energy in the diet of New Zealand adults. Ensuring that trans fatty acid consumption remains below recommended levels, or are reduced even further, will prevent a further increase in the incidence of coronary heart disease in New Zealand.

Steps proposed or being taken to address the issue. A review by Food Standards Australia New Zealand on trans fatty acids in the Australia and New Zealand food supply was presented to the Australia and New Zealand Food Regulation Ministerial Council in May 2007. New Zealander's intakes of trans fatty acids are currently below World Health Organisation recommended levels; however due to the negative effect trans fatty acids have on blood cholesterol, NZFSA officials engaged with food industry representatives to discuss strategies to reduce trans fatty acids in the New Zealand food supply. Following this meeting, the Minister of Food Safety sent a letter to industry participants indicating her support for a non-regulatory approach to managing trans fatty acids and encouraging industry to put strategies in place to assist in the reduction of overall intakes in New Zealand. Details of industries' plans and programmes to reduce trans fatty acids are currently being reviewed by NZ
FSA. Food Standards Australia New Zealand will undertake a further review of trans fatty acid intakes and levels in the Australia and New Zealand food supply in 2009.

Vote Food Safety: Financial Summary

For 2007/08 NZFSA has total revenue of approximately $91 million. Of this, approximately $59 million is cost recovered from industry, primarily the meat and dairy industries with other food sectors contributing lesser amounts. Cost recovered funding covers NZFSA activities, including standard setting, market access, verification and other regulatory functions.

Last year NZFSA undertook a comprehensive review of our cost recovered revenue to ensure alignment with Government and Treasury guidelines. Fees and charges were reviewed at that time and it is proposed to review fees for 2008/09 early next year.

OUTPUT COST
Revenue ($000)

OUTPUT CLASS Crown Department Other Total
F1 - Policy Advice 3,937 21 3,958
F2 - Regulatory Standards 18,177 269 21,824 40,270
F3 - Response to Food Safety Emergency 355 355
F4 - Systems Audit and Enforcement 3,250 60 1,440 4,750
F5 - Consult & Food Safety Info 3,709 19 664 4,392
F6 - Regulatory Programmes 2,165 650 34,944 37,759
Totals 31,593 1,019 58,872 91,484

Vote Food Safety 2008 New Initiative Bids

This section has been withheld

The ground for withholding the information is s.9(2)(j) (the withholding is necessary to enable a Minister of the Crown or any Department or organisation holding the information to carry on, without prejudice or disadvantage, negotiations).

ENDS

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