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

5 Proposed framework for raw milk products

NZFSA is proposing to introduce a framework (the framework) that would allow for raw milk products to be assessed as to whether they can be safely produced, imported, exported and sold in New Zealand, and to identify the specific requirements that would apply to such products. While the framework would cover all raw milk products, only those that could be produced to an acceptable level of safety (that is, present a low food safety risk to the general human population) would be able to be legally produced and imported.

If, following the consultation initiated by this discussion document, a decision is taken to advance the proposed framework, then a second round of public consultation would be initiated providing further details of the framework (for example the criteria for categorising raw milk products) and the draft technical and legal requirements necessary to implement the framework. The framework would apply to products that fall under the Animal Products Act 1999, the Food Act 1981 and the proposed new Food Bill.

5.1 Proposed framework for raw milk products

The proposed framework is based on a ‘category approach’, with raw milk products being grouped into one of three categories according to their food safety risk. The proposed framework includes the following elements:

• three risk categories for raw milk products;

• processes to categorise products into these three categories;

• education of vulnerable consumers;

• labelling of raw milk products that pose a higher risk to vulnerable consumers; and

• revised import standards reflecting the category approach.

5.1.1 Risk assessment

To inform the development of the proposed framework, NZFSA is undertaking a portfolio of risk assessment work concerned with public health risks associated with the consumption of raw milk and milk products. This includes:

• various Risk Profiles including; Listeria monocytogenes in low moisture cheese, Listeria monocytogenes in soft cheeses, Mycobacterium bovis in milk and Shiga toxin-producing Escherichia coli (STEC) in raw milk;

• a review of the science supporting the current dairy pasteurisation time and temperature parameters;

• a qualitative risk assessment of the risk to New Zealand consumers from the consumption of Roquefort cheese;

• a Quantitative Risk Assessment (QRA) to assess the risk to New Zealand consumers from the consumption of raw milk and raw milk products (see 5.1.4. for further information);

• scientific studies relating to heat inactivation of pathogens in raw milk (in partnership with Fonterra) from which data was generated to provide parameters for the Quantitative Risk Assessment; and

• Systematic Review of the human disease evidence associated with the consumption of raw milk and raw milk cheese.

FSANZ is also undertaking microbiological risk and social science assessments relating to the consumption of raw milk and some raw milk cheeses, and NZFSA will be closely monitoring the results of this work.

5.1.2 Proposed category approach

The proposed category approach for raw milk products has been developed after consideration of:

• the existing legal requirements for raw milk cheeses currently able to be sold in New Zealand and Australia, and the risk assessment advice used to determine these requirements, which examined production factors and the intrinsic properties of selected dairy products; and

• FSANZ and EU assessments available for other European-style raw milk cheeses.

Raw milk products would be categorised into one of three categories on the basis of food safety risk to human health. This is determined by the effect that the production methods and the intrinsic characteristics of the final products have on pathogen survival and growth. Processing factors include: curd cooking temperature, acidification and storage time. Intrinsic characteristics include: water activity, moisture content, acidity and salt concentrations. As illustrated below, the potential food safety risk associated with the products in each category would increase from Category 1 to Category 3, with Category 1 products having the lowest risk to human health and Category 3 the highest.

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.

Risk management options for each category would vary and be more comprehensive for higher risk products. The category approach would assist NZFSA to develop risk management options for groups or categories of raw milk products, removing the need for resource intensive and ad hoc case-by-case assessments of individual processes and products.

Prior to the importation of any overseas-made raw milk products not already available in New Zealand, MAF Biosecurity New Zealand would also need to be involved in any necessary revision and/or development of biosecurity import health standards.

5.1.3 Description of categories

The proposed three categories for raw milk products are described below. The descriptions in bold apply to products at the end of the manufacturing process—this includes any maturation of the products as is, for example, required for many cheeses. Also included are some examples of products that could be included in each of the categories and some indication of the risk management options that could apply.

5.1.3.1 Category 1

Category 1 products are defined as those products where intrinsic characteristics and/or processing techniques eliminate pathogens that may have been present in the raw milk.

Examples of products in Category 1 would include the extra hard grating cheeses, which are made from raw milk by heating the curd and have a long maturation/ripening period. These steps result in the death of pathogens and mean that these cheeses have an equivalent level of safety to pasteurised products.

Category 1 raw milk products would pose a low risk (similar to pasteurised and thermised products) to all New Zealand consumers, including vulnerable populations. As a result, they would be able to be produced and imported safely, without additional control measures being required.

5.1.3.2 Category 2

Category 2 products are defined as those 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.

This Category would apply to products where there is possible survival, but not growth of micro-organisms such as Salmonella, Listeria monocytogenes, Campylobacter or Staphylococcus aureus. A combination of control measures and verification procedures (including of on farm practices) additional to those currently applied to dairy products, would be applied to the production of Category 2 products to provide an acceptable level of microbial safety for consumption by the general public.

Based on the previous risk assessments of imported Roquefort cheese, this could be an example of a Category 2 product.

The focus of NZFSA regulatory control would be on allowing the safe production and importation of products in Category 2 (see Section 5.2). Some raw milk products would be assigned to Category 2 with the development of technical criteria to assist in the design, evaluation and verification of FSPs and RMPs for these products.

Products in Category 2 would pose a low food safety risk to the general population, but would potentially be of higher risk to vulnerable groups. The introduction of such products would need to coincide with risk mitigation strategies including education and labelling, to ensure that vulnerable consumers can identify raw milk products in this Category and are aware of the risks posed by their consumption.

5.1.3.3 Category 3

Category 3 products are defined as those products where intrinsic characteristics and/or processing techniques 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.

Category 3 products are those that are not subject to any control measures that would reduce pathogens to an acceptable level. In general, if pathogens are present, they would be expected to multiply during any processing, maturation or storage steps and in the final product. This Category would include products such as raw drinking milk and would be likely to include high moisture content cheeses, such as unripened cheeses.

Category 3 products would not be able to be legally produced in New Zealand or imported because there are no appropriate processing techniques that could ensure such products are safe for consumption by the general New Zealand population, given the level of safety currently seen as acceptable to New Zealanders.

5.1.4 Categorisation of raw milk products

NZFSA proposes to develop tools to assist with categorisation of raw milk products.

It is proposed initial categorisation of products into Category 1 be determined by a filter based on processing factors and product characteristics (e.g. pH, salt level, moisture). Raw milk products that did not meet the criteria of Category 1 would fall into either Category 2 or Category 3. A second filter will be necessary to categorise many of the raw milk products into either Category 2 or Category 3.

The second filter will include a Quantitative Risk Assessment (QRA) that has been developed in order to assess the risk to New Zealand consumers from the consumption of raw milk and raw milk cheeses. The QRA takes a farm-to-fork approach from primary production, through milk processing, product manufacture, sale and consumption. The results from the QRA will then aid the categorisation of the product into either Category 2 or Category 3.

However, for some products manufacturers or importers will need to provide NZFSA with additional evidence to demonstrate that processing factors and the intrinsic characteristic of a product/category of product can provide for an acceptable level of safety.

Raw milk products that are placed in Category 3 would not be able to be produced or imported given the level of safety currently seen as acceptable for New Zealanders. Those wanting to manufacture or import a product in Category 3 would be required to specify additional processing steps that would be introduced to increase the safety of the product and show how these steps would be validated. If NZFSA accepts that the product could be produced to an acceptable level of safety with these additional controls, then it would be moved into Category 2. If not, the product would remain in Category 3.

It is likely that ongoing monitoring will be required to confirm that particular products have been categorised correctly and that these categories remain valid.

5.2 Preliminary risk management options for categories

Raw milk products that can be produced safely without additional control measures would fall into Category 1, whilst Category 3 products would not be able to be manufactured or imported for sale. As a result, the regulatory framework would focus on Category 2 products and the additional control measures or requirements that would be necessary to produce Category 2 products to an acceptable level of safety. It is likely that measures relating to Category 2 milk harvesting and milk processing would also require closer monitoring and control throughout the production life cycle, compared to Category 1.

5.2.1 Category 2

NZFSA has undertaken some preliminary work to consider what additional measures or requirements might be necessary to ensure that Category 2 raw milk products have an acceptable level of safety (whilst acknowledging that these measure would only need to be introduced if the framework is agreed). NZFSA has split the process into two stages: milk harvesting and milk processing. The following is an indication of what NZFSA may propose.

Milk Harvesting:

At present, requirements related to the harvesting of milk on the farm are set out under the Animal Products Act 1999. If the proposed framework is agreed, there would need to be additional requirements for the harvesting of the milk used to produce raw milk products.

Current milk harvesting requirements are based on the assumption that the milk will be pasteurised, which kills or inactivates foodborne pathogens. As raw milk products are not subjected to this processing step, it is crucial that the levels of pathogens in raw milk are kept as low as possible. The areas that would need to be considered when determining the requirements for raw milk production are still to be finalised, but would include animal health, feeding, transport and storage times, temperature control and registration of farm dairies.

The requirements for raw milk harvesting would be based on the guidelines established for raw milk products by the Codex Alimentarius Commission. This approach is considered appropriate due to:

• the clear and existing guidance on risk management options for raw milk products provided in the Codex Code of Hygienic Practice for Milk and Milk Products;

• the large number of milk harvesting operations in New Zealand, which require a detailed approach to ensure the methods that are used to achieve food safety are consistent and effective; and

• the proposed approach needing to be consistent with the current mandate of the Animal Products Act, because milk harvesting does not fall within the scope of the Food Act.

Milk Processing:

The proposed processing requirements for the manufacture of raw milk products would most likely be more outcome based and less detailed than the requirements applied at the milk harvesting stage. NZFSA considers that this is appropriate due to the diversity of processing conditions that are potentially available and that could be used to safely produce raw milk products.

Processing controls that may be required could include: the use of starter cultures in fermented products; acid production including target pH values and the time for acid development; salting procedures and salt levels; and curing or ripening conditions.

Should the proposed framework for raw milk products be agreed, NZFSA would need to consider how these processing requirements would be implemented under both the Animal Products Act and the Food Act.

5.3 Other risk mitigation considerations

As part of the proposed framework, NZFSA has been undertaking preliminary consideration of ways of helping to mitigate the risks associated with consumption of raw milk products. Raw milk products can contain harmful pathogens that may cause serious illnesses and be life-threatening to vulnerable groups. In countries where raw milk cheeses are part of the culture, the longstanding culinary tradition means there is widespread awareness of the risks of consuming raw milk products. However, as these products are new to New Zealand, raising public awareness of the risks involved in their consumption by vulnerable groups is very important.

5.3.1 Consumer education programme

NZFSA operates an education programme for vulnerable groups to communicate information about public food safety risks to both vulnerable groups (the young, frail elderly, expectant mothers and the immune-compromised), and other members of the community.

In 2007 NZFSA broadened its education programme to include the raw milk cheese Roquefort, following amendments to the legislation that allowed the direct importation and sale of this product. Activities included articles in NZFSA publications and consumer magazines, media releases, and flyers displayed at points-of-sale. In addition, NZFSA specifically targeted at-risk groups by distributing information to every medical centre and midwife in New Zealand.

Should the framework for raw milk products be agreed, NZFSA would further utilise its education programme for vulnerable groups to communicate the risks associated with raw milk products generally in order to ensure consumers make informed choices. NZFSA is currently reviewing the effectiveness of the education programme for Roquefort cheese. This will assist in determining if any changes or additions to the programme may be required in future.

As part of the consultation process initiated by this discussion document, NZFSA would welcome feedback on effective and equitable strategies to communicate with vulnerable groups.

5.3.2 Consumer survey

To enhance the design and effectiveness of its education programme and to gain more information on New Zealand consumers’ understanding of raw milk products, NZFSA is commissioning a survey of consumers, the hospitality and retail trade, and health professionals.

The primary objectives of the NZFSA consumer survey are to determine public awareness and understanding:

• of terms such as ‘raw milk’, ‘un-pasteurised milk’, ‘pasteurised milk’ and ‘raw milk cheese’;

• of the risks associated with the consumption of raw milk products; and

• that raw milk products pose relatively greater risks to some vulnerable population groups.

The survey will also ask participants about their current and expected future consumption of raw milk products, and their expectations about labelling and the content and placement of information material.

In association with the survey, NZFSA will also use small focus groups to discuss labelling options, including the need for advisory statements, wording for labelling and the effectiveness of NZFSA’s education materials for vulnerable consumers.

FSANZ is also commissioning research into Australian consumer behaviours and motivations in respect of raw milk products, and NZFSA will be taking an interest in the findings of the FSANZ research with the view to better informing New Zealand education strategies.

5.3.3 Labelling

The labelling requirements for all food (including dairy products) sold in New Zealand are set out in the Australia New Zealand Food Standards Code (the Code). Among other things, the Code requires that the label on a package of food for retail sale must include the name of the food and a list of its ingredients. In the case of raw milk products, the list of ingredients would include raw (or unpasteurised) milk.

Mandatory advisory statements are used when consumption of a food exposes the general population or a population subgroup to a health and safety risk, or where guidance about a food is needed to maintain public health and safety. The list of foods that are required by the Code to have a mandatory advisory statement includes unpasteurised milk and liquid milk products, but does not currently include raw milk cheeses or other raw milk products. This means that the labelling on unpasteurised milk and liquid milk products must include an advisory statement “to the effect that the product has not been pasteurised”, but that no such mandatory advisory statements nor any other warnings are required on the labels of raw milk cheeses or other raw milk products.

The consumer survey being commissioned by NZFSA will provide data about New Zealand consumers’ understanding of raw milk products. Combined with the feedback received in response to this discussion document, this is expected to assist with determining whether the current labelling requirements for raw milk products are considered sufficient, or whether these requirements should be strengthened and if so how this may be achieved. One possibility is the use of mandatory advisory statements to more clearly differentiate raw milk products.

The need for any change to the current labelling requirements is also an area in which NZFSA will continue to collaborate and consult with FSANZ.

5.4 Imported food standard for raw milk products

Raw milk cheeses are currently included in the Food (Prescribed Foods) Standard 2007 as they are considered a high risk food. This recognises that some foods, because of their nature or the way in which they are handled, can pose an increased risk of illness to consumers. The Prescribed Food Standard details which foods are prescribed and also the hazards for which they can be monitored.

New Zealand legislation permits the importation and sale of three named hard and very hard Swiss raw milk cheeses, extra-hard raw milk Parmesan style grating cheeses, and Roquefort cheese. These cheeses are listed in the Food (Milk and Milk Products Processing) Standard 2007. Raw milk cheeses can only be imported from an exporting country that operates a production programme that has been assessed and recognised as equivalent to, or complying with, New Zealand’s standards, through a country-to-country arrangement.

Development of a future import standard for raw milk products would be based on the outcome of any New Zealand processing standard for raw milk products, with the same category approach (as outlined in Section 5.1) being applied. Under the new Imported Food Regime, which is currently in the process of being implemented, many raw milk products are likely to be classed as high regulatory interest foods. This means such products would only be able to be imported from countries with which New Zealand has a country-to-country arrangement. This would provide a high level of food safety assurance prior to these products entering New Zealand.

MAF Biosecurity New Zealand (MAFBNZ) is responsible for ensuring all New Zealanders, our natural resources, plants and animals are protected from the potential introduction of pests and diseases.  MAFBNZ develops Import Health Standards which are issued under the Biosecurity Act 1993. They state the requirements that must be met before goods identified as a risk to our biosecurity can be imported into New Zealand. In order for a wider range of raw milk products to be introduced, MAFBNZ would need to develop Import Health Standards for these products and the development of such Import Health Standards would need to be prioritised against other projects on the MAFBNZ work programme.

5.5 Exports

If permitted, the New Zealand manufacture and export of raw milk products could potentially open new export market opportunities, since previously all dairy products exported from New Zealand have been pasteurised. The possible future volumes/value of exports of raw milk products are not able to be precisely quantified at this time by NZFSA. Initially such trade is likely to be small, but potentially it could grow considerably. Balanced against this benefit there is, however, a need to ensure that the current significant export trade in pasteurised products is protected, as a damaging food safety incident relating to an exported raw milk product could impact not only on raw milk product exports, but on all New Zealand dairy exports.

All food products exported from New Zealand must be produced in accordance with New Zealand legislative requirements and also meet the legislative requirements of the importing country. Should the proposal outlined in this discussion document proceed, the development of general export standards for raw milk products may be necessary but would be dependent on the outcome of the New Zealand standard for such products. Any additional export requirements would most likely relate to verification activities from farm through to export, the separation and identification of raw milk products post manufacture, and official certification. However, it is likely that any additional general export requirements would be minimal.

NZFSA is also undertaking initial review of other elements that could impact on any future export of raw milk products including:

• Labelling: Since all dairy products exported from New Zealand have, to date, been pasteurised, it may be prudent to provide clear information on the label of all unpasteurised export dairy products to prevent misconception by importing countries unaware of the change in New Zealand policy. This would also ensure that foreign consumers are made aware of any risks posed by the consumption of New Zealand raw milk products.

• Export certificates: NZFSA is reviewing export certificate templates for dairy products to ensure declarations would be compatible with the certification of both raw milk and pasteurised products processed in New Zealand.

• Export requirement notices: These generally specify whether or not dairy products must be pasteurised, and for many countries, this requirement has been established for many years. NZFSA is obtaining updated information on the import requirements for raw milk products in potentially important export markets such as the EU, the USA and Canada. Requirements for other markets would be established or reviewed on a country by country basis, on request from exporters prior to export, and the relevant export requirement notice amended accordingly.

5.6 Cost recovery

If a decision is taken to facilitate the local production of raw milk products and the importation of a similar range of such products, NZFSA would apply its cost recovery policy and framework to determine which of the associated activities need to be funded privately or through industry, rather than through Crown funding. Further information about any fees, charges or levies relating to raw milk products would be discussed during the second round of consultation, should this proceed.⁸

⁸ For further details on the NZFSA cost recovery policy and framework, see the NZFSA Background Paper No 06/04: Cost Recovery Policy and Framework at http://www.nzfsa.govt.nz/policy-law/publications/reports/cost-recovery/index.htm