The Food Standards Agency (FSA) has developed a guidance document for producers of raw drinking milk in England and Wales.

The guidance has been produced in response to increasing sales and outbreaks related to unpasteurized milk. Between 2015 and 2017 there were five outbreaks linked to raw milk. These included 103 reported cases, 40 of which were laboratory /confirm/ied. Children were unwell in all outbreaks and some were hospitalized.

It will apply beginning April 1, but does not cover dairy products made using raw drinking milk. Sales of raw milk and cream are banned in Scotland.

FSMS and pathogen testing
Raw drinking milk producers are legally required to create and implement a system which assesses what could go wrong to affect safety of their product and identify controls to stop that from happening.

There are no legislative changes but the FSA is more explicit in the controls that should be implemented by producers so they can demonstrate compliance with legislation and try and ensure products are as safe as possible.

Main controls emphasized in the guidance are to have an effective and verified Food Safety Management System (FSMS) which is a legal requirement and to commit to testing for pathogens which can be found in raw milk. Failure to have an adequate FSMS could result in enforcement action against a producer.

FSA dairy hygiene inspectors visit farms producing raw drinking milk twice per year to check adequate procedures are in place.

Consultation key points
The FSA held a public comment period from February to April 2019 on proposed enhanced controls in the production of raw milk. Since action was proposed in June 2018, there were another two outbreaks linked to raw milk until October 2019.

Responses to this consultation saw the FSA acknowledge if milking was between once and twice a day, annual costs to industry for recordkeeping would, on average, increase from £41,000 ($53,400) to £71,000 ($92,500). The estimated one-off cost to industry for implementing a FSMS could increase from £10,000 ($13,000) to £72,000 ($93,800) or £445 ($580) per producer.

Concerns were also raised about the price and lack of labs that test for Shiga toxin-producing E. coli.

FSA said testing for E. coli O157 rather than all STEC reduces protection for public health. The agency acknowledged the burden on businesses and said it was trying to balance the need to protect public health and the sampling and testing burden.

Michael Wight, head of food safety policy at the FSA, said it was important to strike a balance between protecting public health, preserving consumer choice and supporting business.

“Food businesses must follow the measures set out in this guidance in order to reduce the health risk to consumers from this product. The FSA will continue to monitor any health incidents associated with raw drinking milk to see if these measures are sufficient.”

Producer responsibility
Raw drinking milk is considered a risky food by the FSA so enhanced measures are in place to protect public health. If they are not effective, then the agency will consider if further regulatory or legislative measures may be required. The guidance will be reviewed in February 2021.

FSA advises that pregnant women, infants and small children, elderly people, and those with weaker immune systems caused by health problems should not have raw milk. However, the agency said the risk is not so unacceptable as to justify removing the right of adults to choose to drink it.

Sellers are required to ensure that raw drinking milk meets microbiological standards of a coliform count of less than 100 colony-forming units per milliliter (cfu/ml) and an aerobic colony count at 30 degrees C (86 degrees F) of less than 20,000 cfu/ml. There are no legislative requirements for pathogen testing but it is encouraged by the FSA. EU regulation has limits for Listeria monocytogenes in ready-to-eat food such as raw milk.

Tali Eichner, membership secretary of the Raw Milk Producers Association, said the new controls are practical for producers and focused on improving food safety.

“The approach proposed by the FSA meets this need by enabling the producer to assess the risks in their own system and setting controls appropriate to their individual situation.”

Raw milk produced from all species, except buffalo, must carry this warning: “This milk has not been heat-treated and may therefore contain organisms harmful to health.” In Wales and Northern Ireland, in addition to this wording, a statement must be on the container or at point of sale saying: “The Food Standards Agency strongly advises that it should not be consumed by children, pregnant women, older people or those who are unwell or have chronic illness.”

A date is not yet set for a label alteration in England but any changes to requirements will allow a three year transitional period.