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Proposed framework for the manufacture, importation and sale of raw milk products

1 Executive summary

1.1 Purpose of this document

The purpose of this discussion document is to provide information and seek submissions on a proposed framework (the framework) developed by the New Zealand Food Safety Authority (NZFSA) that, if progressed, would facilitate the manufacture and domestic sale or export of some raw milk products for human consumption, and the importation and sale of a similar range of raw milk products.

Submissions on this discussion document are invited to be made to NZFSA by 30 September 2008. All submissions received will be analysed and a decision then taken about whether to progress the proposed framework for raw milk products.

Should the framework be progressed, then a second round of consultation would be initiated in 2009 on the specific detail of the various elements that would be necessary to implement the framework. These elements would likely include:

• the additional technical requirements that would apply to any raw milk products able to be produced in New Zealand;

• how the requirements would be implemented in New Zealand food legislation;

• the interface with the implementation of the Imported Food Review, including the proposed high, medium and low regulatory interest categories of imported foods and the possible need to review any applicable biosecurity import health standards; and

• measures that would be introduced to mitigate potential risks that raw milk products can pose to vulnerable consumers eg labelling, and education programmes.

This document refers to some technical terms and readers should refer to the glossary in Section 9 for definitions.

1.2 Raw milk products and the scope of this proposal

All foods have the potential to cause foodborne illness and milk and milk products are no exception. Dairy animals may carry human pathogens (organisms which can cause a foodborne illness) that can be present in the milk used to produce dairy products. The composition of some dairy products (eg soft cheeses) means that they provide a good environment for the growth of any pathogens that may have been present in the milk used to produce them.

Some heat treatments such as pasteurisation raise the temperature of the milk used to produce dairy products to a degree that is sufficient to kill or inactivate pathogens, making these products low risk¹. However, other dairy products are made from milk that has not undergone such a heat treatment. Broadly speaking these products are generally referred to as raw milk products, but it is important to note that there is no universally agreed definition of raw milk products, with several technical definitions in use internationally, including one used by the Codex Alimentarius, which is the international food standards setting body (see Section 3.2.5.1).

This document does not propose a definition for raw milk products for New Zealand purposes (this would instead be developed as part of the more specific technical work that could follow if a decision is taken to adopt the framework). However, this document does outline what is meant by raw milk products in order to explain the scope of the framework that is proposed. Raw milk products are defined for the purposes of this document as products that have been produced from milk that has not been pasteurised or thermised in accordance with the Food (Milk and Milk Products Processing) Standard 2007. The framework proposed in this document would cover products for human consumption that have been manufactured from the raw milk of a number of milking animals including cow, goat, sheep, buffalo, horse and camel. These products would include cheeses and yogurts. The proposal does not, however, make any change to the existing allowance under Section 11A of the Food Act 1981 for up to five litres of raw milk to be purchased for personal consumption from the farm gate.

Some raw milk products can be made in such a way that pathogens that may have been present in the raw milk used to produce them are eliminated or have their growth inhibited. As a result, raw milk products such as cheeses present a range of food safety risks, from those that are as safe as cheese made from pasteurised milk (such as certain hard and very hard raw milk cheeses), to those that pose a higher risk to all consumers (such as soft unripened raw milk cheeses).

NZFSA believes it is possible to allow the importation of a wider range of raw milk products than is currently provided for, and to enable the production of equivalent products in New Zealand, by ensuring they are made from milk produced under particularly stringent conditions of animal health, and by following appropriate processing hygiene and controls. The types of products permitted under the proposed NZFSA framework would therefore be those that achieve an acceptable level of microbial safety for the general population.

Some vulnerable groups in the population can potentially face greater risks (serious or life-threatening illness) from eating raw milk products, just as they face similar risks from eating some other commonly available foods, such as raw shellfish. These vulnerable groups consist of babies and toddlers, expectant mothers, the frail elderly, and anyone whose immune system may be compromised because of a chronic illness, long term medication or a recent operation. For example, these groups are highly susceptible to some microbiological hazards (eg Listeria, Salmonella, Escherichia coli) that may be present in raw milk products. The NZFSA proposal set out in this discussion document is based upon mitigating the risks to vulnerable consumers by educating them about the risks associated with those raw milk products that pose a higher risk than pasteurised and thermised products, and by labelling such products so vulnerable consumers can avoid them.

It is also possible that many raw milk products would have a niche market status (ie made or imported in limited quantities and be highly priced). As such the availability of these products, and therefore the exposure of the majority of the New Zealand population to them, would be limited, thus also limiting the probability of any impact occurring from any risk the products may pose.

1.3 Background to this proposal

1.3.1 Current availability of raw milk products in New Zealand

Currently all dairy products manufactured in New Zealand are made from pasteurised or thermised milk.² The only exception to this is the “Five-Litre” Rule, which is provided for in Section 11A of the Food Act and allows producers to sell up to five litres of raw milk at any one time from their farm gate to people who intend to consume it themselves or provide it to their family. The only raw milk products that can legally be imported and sold in New Zealand are a limited variety of cheeses, following case-by-case assessments of the risks that the particular cheeses pose to consumers and attestation that any relevant import health standards can be attained.

Domestic dairy producers can apply to NZFSA for approval to manufacture raw milk products under a Risk Management Programme (RMP) under the Animal Products Act 1999 or a Food Safety Programme (FSP) under the Food Act 1981. However, there are no technical criteria or other guidance material in place to assist with the development, evaluation, assessment for registration and subsequent verification of such a programme. This has contributed to the fact that no manufacturer has applied to NZFSA for registration of a programme to cover the manufacture of raw milk products in New Zealand.

New Zealand food legislation currently permits the importation and sale of the following raw milk cheeses: three named hard and very hard Swiss cheeses, extra-hard Parmesan style grating cheeses, and Roquefort cheese. The hard, very hard and extra-hard grating cheeses were only allowed to be sold in New Zealand (and Australia) following risk assessments carried out by Food Standards Australia New Zealand (FSANZ)³. These cheeses have low moisture content and a very long storage period and are not considered to pose a risk to consumers. As a semi-hard raw milk cheese, Roquefort has different properties than the hard and extra-hard cheeses and, therefore, NZFSA conducted its own risk assessment of Roquefort, prior to recommending its direct importation and sale in New Zealand. The NZFSA risk assessment of Roquefort indicated that consumption would constitute a low risk to most New Zealand consumers but a higher risk to vulnerable groups. These vulnerable groups are highly susceptible to some microbiological hazards (particularly Listeria) that may be present in raw milk products. Risk management measures, including a consumer education programme, have been introduced to mitigate the risks to these vulnerable groups.

1.3.2 The impetus for change

In some parts of the world there is a culinary tradition of raw milk products (particularly cheeses), and such products are widely available. In recent years there has been increasing interest in the availability of raw milk products within New Zealand. Requests have been made to NZFSA to allow more raw milk products (particularly cheeses) to be imported, and to develop the relevant technical criteria and other guidance material that would allow for the domestic manufacture and sale of raw milk products.

This interest in raw milk products comes from consumers, importers and domestic manufacturers. Some consumers want a wider range of products to be available in New Zealand as they are in other countries, and may consider that raw milk products are superior in flavour and texture, as well as offering health benefits. Importers see potential business opportunities, for example to supply gourmet speciality cheeses, and are concerned about the restrictions imposed by the current regulatory regime. New Zealand dairy manufacturers, including smaller specialist cheese makers, are concerned about the inequity of the current situation whereby importation of some raw milk cheeses is allowed, but no provision for the manufacture of similar cheeses in New Zealand has been made. Such manufacturers have expressed an interest in producing raw milk cheeses and see this as a business opportunity, both in terms of sales in the domestic market and possibly in export markets.

In relation to imported products, NZFSA must also ensure that import standards and requirements meet the World Trade Organization (WTO) Sanitary Phytosanitary Agreement and obligations under the European Commission/New Zealand Sanitary Agreement. New Zealand’s current import requirements have allowed some raw milk products to be imported on the basis of individual risk assessments (including Roquefort cheese), but not others (see Section 3.2.1.2 for the background to these decisions). Some of New Zealand’s trading partners have questioned why this is the case. Completing the individual risk assessments for these imported cheeses has also been resource intensive and has resulted in decisions being made on a case-by-case basis.

Australia is also considering new legislation to allow the production and importation of a wider range of raw milk products. Under the Trans-Tasman Mutual Recognition Agreement (TTMRA) food produced in New Zealand or imported into New Zealand that meets New Zealand's legal requirements, may also be sold in Australia and vice versa. There are some exceptions, however, with for example, high-risk foods listed in either country requiring certification or testing before being permitted entry. The limited range of raw milk cheeses currently able to be imported into New Zealand is included on the high risk list.

As a result of all these factors, NZFSA has been investigating ways of expanding the regulatory framework, should a decision be taken to allow a wider range of raw milk products to be manufactured in, and imported into, New Zealand.

In developing this framework and now providing an opportunity for a consultation process, NZFSA does however acknowledge that some New Zealanders may not support raw milk products becoming more widely available in New Zealand.

1.4 NZFSA proposal

NZFSA commenced consideration of a range of options relating to the domestic production and importation of raw milk products following the 2007 risk assessment and risk management decision for Roquefort cheese. These options are outlined in detail in Section 6 of this document. NZFSA’s preferred option is to develop an appropriate regulatory framework that would allow for both New Zealand production of some raw milk products and the importation of a similar range of raw milk products, without the need for full individual risk assessments on a product-by-product basis, while maintaining an acceptable level of consumer protection.

To support the development and analysis of options related to raw milk production and importation, NZFSA is undertaking a portfolio of risk assessment work concerned with the public health risks associated with the consumption of raw milk and raw milk products. Further details about this work are provided in Section 5.1.1.

NZFSA is working in collaboration with Australia on a proposed framework based on a ‘category approach’. Instead of case-by-case assessments, raw milk products would be placed in one of three categories according to their food safety risk to human health. The categories would be used as the basis for determining the additional requirements, if any, necessary to produce raw milk products with a low or acceptable food safety risk. Under this framework, it is expected that some types of raw milk products would still not be able to be imported or made in New Zealand.

The categories are defined depending on the effect that production and processing techniques, and the intrinsic characteristics of the final products, have on the survival and growth of pathogens that may be present in the raw milk. Raw milk products which allow for the survival and/or growth of pathogens pose a greater food safety risk, compared to products where pathogen growth and survival is less likely.

The potential food safety risk associated with each Category increases from Category 1 to Category 3 as illustrated below:

Category 1 Products where intrinsic characteristics and/or processing techniques eliminate pathogens that may have been present in the raw milk Category 2 Products where intrinsic characteristics and/or processing techniques may allow the survival of pathogens that may have been present in the raw milk but do not support the growth of these pathogens Category 3 Products where intrinsic characteristics and/or processing conditions are likely to allow the survival of pathogens that may have been present in the raw milk and may support the growth of these pathogens.

The category approach would assist NZFSA with developing risk management measures; for example such measures would be more comprehensive for Category 2 products than for Category 1 products.

It is considered that Category 1 products would be able to be safely produced or imported without additional control measures being required.

The focus of regulatory control would be on Category 2 products, with regulatory measures expected to be developed relating to the harvesting of raw milk on farms and the processing into the resulting products.

Category 3 products would not be able to be produced or imported into New Zealand, given the level of safety currently seen as acceptable for New Zealanders. These products would include raw drinking milk.

Further details of this framework, including examples of products likely to fall under each Category, are provided in Section 5.

NZFSA considers it important that, if this category approach is adopted, it is introduced simultaneously with a range of strategies designed to mitigate the risks that the consumption of some raw milk products (likely to be those products in Category 2), would pose to vulnerable groups of consumers. These strategies would include the broadening of NZFSA’s consumer education programme and the commissioning of a consumer survey to inform educative material and to provide input into decisions about appropriate labelling for raw milk products.

¹ This does not preclude contamination during processing or post processing which is a risk for all dairy products.

² For an explanation of this and other technical terms, refer to the Glossary in Section 9.

³ FSANZ is responsible for developing food standards for both New Zealand and Australia (see Section 3.2.1.1. for more information).