Legal Ramifications in Supply of Unpasteurised Milk
The New South Wales Food Authority recently warned consumers against drinking unpasteurised milk which is being widely marketed under the guise of a pet food or as a cosmetic (eg bathtime) product. This article discusses the sale of unpasteurised milk and milk products for human consumption throughout Australia, and the risks that are being posed.
A NSW Food Authority media release on 23 October 2007 advised that the Authority had received numerous complaints about ‘rogue traders’ selling unpasteurised milk, packaged as pet food or cosmetics, for human consumption. A less publicised warning regarding unpasteurised milk was also made by Dairy Food Safety Victoria in September 2007 when investigators discovered businesses supplying the product as a drink.
Recent media reports have warned of a growing consumer demand for unpasteurised milk. Put simply, milk that has not undergone the pasteurisation process is considered to be ‘raw milk’ or milk that is straight from the cow. Pasteurisation, through the process of heat treatment, destroys any viruses or harmful bacteria that may be present in raw milk. A number of organic food industry players argue raw milk is a healthier option than pasteurised milk considering that many of the vitamins, minerals and enzymes in raw milk are destroyed when milk is pasteurised.
Yet serious health risks are associated with the consumption of unpasteurised milk or dairy products. First of all, one needs to bear in mind that raw milk is potentially very vulnerable to pathogenic contamination in the production process, not least because of the location of a cow’s udder just beneath the rear end of the animal! Farmers are extremely careful but pasteurisation is an additional protective step. Secondly, a cow’s milk can inherently carry pathogens such as viruses that can be transmitted to humans. We all know how smallpox was a human-borne illness that was a variant of a cow-related viral disease. In the post-WWI era, Australian State elections were being fought by campaigners seeking pasteurisation of all milk supplies because of the high number of Australian lives being lost as a result of milk-borne bacteria causing fatal infections.
Pasteurisation destroys a large proportion of harmful bacteria such as Salmonella, Campylobacter and pathogenic Escherichia coli, which is often present in raw milk, such that they remain present in the final product only at levels that are no longer harmful while maintaining the integrity of proteins in the milk which break down with intensive heat treatment. In 2002, the Journal of Communicable Diseases Intelligence (on the Federal government Department of Health and Aging website) received notification of an outbreak of Cryptosporidium in primary school aged children causing severe vomiting and diarrhoea. All eight children had consumed unpasteurised milk that was marketed and sold as pet milk. The bacteria causing the illness would not have been present at harmful levels in the milk if it had been pasteurised.
The current law under food safety legislation and the Food Standards Code
At present, there are laws banning both the sale of unpasteurised milk as a human drink and the use of raw milk in the cheese production process. In Victoria, supplying unpasteurised milk or dairy products for human consumption carries a fine of up to $44,000 (s. 36 Dairy Act). The sale of unpasteurised milk or dairy products, in NSW, is a breach of the Food Regulation 2004 and may incur a fine of up to $275,000 under Section 21 of the Food Act for breach of Regulation 46 of the Food Regulation 2004.
The Food Standards Code Australia and New Zealand (Standard 1.6.2, Clause 1) prescribes the process of pasteurisation that must be complied with including the specific temperatures and the duration of the heating period. Under the Food Standards Code, cheese or cheese products must be manufactured from milk or milk products that have been heat-treated or pasteurised (Standard 1.6.2, Clause 2).
FSANZ and the cheese production Standard
Prior to 2002 (under the old version of the Food Standards Code), the milk provisions of the Australia New Zealand Food Standards Code did require pasteurisation but there existed a loophole for many raw milk based hard cheeses such as Parmigiano Reggiano and Grana Padano to still be legally imported into Australia. This was because the adequate heat treatment of milk was determined by the level of the enzyme alkaline phosphatase (which breaks down with heat treatment) in the product, and certain raw milk based hard cheeses do not have high levels of alkaline phosphatase to begin with.
This alkaline phosphatase indicator was removed in 2002 with the introduction of the new Australia New Zealand Food Standards Code and therefore introduced a blanket prohibition on all raw milk and raw milk based cheeses.
A proposal (Proposal P263) was introduced by FSANZ’s predecessor ANZFA immediately following the introduction of the new Australia New Zealand Food Standards Code in 2002. The Final Assessment Report of the Proposal P293 ‘Safety assessment of raw milk, very hard cooked curd cheeses’ recommended several amendments to the pasteurisation process to allow very hard cooked curd cheeses (such as Grana Padano and Parmigiano Reggiano) to be legally sold. Standard 1.6.2, Clause 2(1)(b) allows hard grating cheese (cheese which has a moisture content less than 36% and has been matured/stored for at least 6 months) to be sold if it is stored at a temperature of no less than 10°C for a period of no less than 6 months from the date of manufacture and where the curd is heated to a temperature of no less than 48°C. This describes the usual method of production for very hard grating cheeses thus effectively providing an exemption from the pasteurisation process for these types of hard cheeses. FSANZ believes that grating style cheeses have a long history without adverse health consequences and are deemed to meet the same level of safety as cheese produced from pasteurised milk.
Some other specific cheeses made from raw milk have been granted specific exemption under Clause 1 of Standard 4.2.4A of the Australia New Zealand Food Standards Code. Gruyere, Sbrinz and Emmental cheeses now have specific permission after the Swiss government in 1998 applied to ANZFA (which was succeeded by FSANZ) for an order to permit the importation of Gruyere, Sbrinz and Emmental cheeses into Australia.
Another raw milk based cheese which has been granted approval by FSANZ is Roquefort cheese following an Application in 2004 by the French government. Roquefort cheeses can be sold in Australia as long as certain requirements such as pH, salt and moisture levels during production and storage and microbiological requirements are met.
Clearly despite the general ban on unpasteurised dairy, these instances illustrate that appropriate applications can be made to FSANZ to permit certain types of unpasteurised milk or dairy products where it can be shown that there are no safety risks in the consumption of the product.
For the approved raw milk products, manufacturers of these products must include a warning on the label to state that the product is made from unpasteurised milk (Standard 1.2.3) and all cheeses, whether produced by raw milk or not must still meet microbiological standards (Standard 1.6.2). The legal liabilities and responsibilities upon those producing cheese from raw milk are no different to other cheese manufacturers – the product must still be safe for human consumption.
The legal ramifications of supplying raw milk
As mentioned earlier, raw milk is currently being produced and generally marketed in various places as either pet food or a product to be used for cosmetic purposes (commonly as a ‘milk bath’). Some consumers believe that raw milk supplied under the guise of pet food or a cosmetic is simply a ruse to circumvent the hurdle of illegality of selling unpasteurised milk for human consumption. There are a number of factors that support this view. Firstly, raw milk sold as a milk bath costs approximately $3 per litre meaning that filling a bath would become quite a very costly exercise. Secondly, unpasteurised milk is commonly being found in health food shops rather than cosmetic outlets, and thirdly, Victorian Dairy Food Safety investigators have recently caught retailers advising consumers that raw milk is healthy and beneficial.
Notwithstanding the fines applicable under food safety legislation, the sale of raw milk or milk products for human consumption may incur broader legal consequences. The historic case Donoghue v Stevenson (where a manufacturer of ginger beer was liable for injuries caused by the remains of a snail) established that food manufacturers owe a legal duty of care to the consumers of their products. The duty of care would generally arise to protect consumers from harm resulting from reasonable uses of the product. Manufacturers producing raw milk as a cosmetic would generally owe a duty of care to ensure the product was safe for use as a cosmetic rather than a drink. However, a duty of care to all consumers, for all uses, may be considered too wide and burdensome for manufacturers especially since it may open the floodgates to many actions of negligence. On the other hand, tortious liability is based on the concept of a hypothetical ‘reasonable person.’ If raw milk is being sold in the same shop that sells foods, (eg a health food shop), it may be reasonably foreseeable that consumers might drink the product. However, where products are packaged and labelled sufficiently to indicate that the product is not for human consumption it would be unlikely that a reasonable person, in the position of the consumer, would consume the product and expect it to be safe for human consumption.
The supply of raw milk, even for cosmetic or pet food purposes, may breach Part VA of the Trade Practices Act (TPA) which prohibits the supply of “goods having defect”. “Goods having defect” is defined under Section 75AC to mean goods where the “safety is not such as persons generally are entitled to expect”. The determination of the safety of goods also takes into account the way in which a product is marketed and any warning statements on the product. Yet the word “milk” by itself may imply to the reasonable consumer that the product is a consumable product and, as such, the standard of safety expected by consumers for the product may be that of a food. There is a real risk that if raw milk is sold and harm results from the consumption of the raw milk, then the manufacturer or distributor will become liable for damages, notwithstanding a warning on the label.
The supply of raw milk marketed as a cosmetic or pet food but really intended for human consumption may also breach Section 52 of the Trade Practices Act (TPA). The principal provision provides:
“A corporation shall not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive”.
Conduct is regarded as misleading if it has the capacity to lead into or cause error – ie a situation where a person is led to believe things notwithstanding that these are not true or correct. Manufacturers of raw milk would not be in breach of Section 52 on account of simply manufacturing and supplying the product to retail outlets. Their products contain labels that expressly advise of the intended use of the product and indicate the product is not manufactured for human consumption.
However, retail outlets stocking raw milk products are most at risk of liability under the Section 52 provision. Consumers may be mislead into believing that raw milk is a safe and healthy drink based on the advice or intimations or inferences given by the retail assistants selling the raw milk products. If, in fact, the consumer suffers injury as a result of consuming the product an action under Section 52 of the TPA could be brought on the basis that the misleading conduct would have led the consumer to believe erroneously that the product would be beneficial. It must be noted, however, that provisions under the TPA now significantly limit the amount of damages recoverable so that the consumer must suffer quite serious injury before damages can be awarded. Nonetheless, the ACCC or other responsible government agencies at Federal and State levels would be in a position to instigate legal proceedings under these or similar statutory provisions.
The sale of raw milk for human consumption will attract legal consequences. To avoid adverse legal ramifications, manufacturers must ensure that their products are packaged and labelled correctly to avoid any situation where consumers may believe or be misled. Retailers must also advise their staff not to recommend (either expressly or by inference) any raw milk product as a drink. Most importantly, consumers should be informed of the high risk of serious illness from consuming raw milk.
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