Reducing the Risk from E. coli O157 – controlling cross contamination (Scotland)

Who will this consultation be of most interest to?
All food businesses handling both raw and ready to eat (RTE) foods
Officials delivering official controls in food businesses

What is the subject of this consultation?
The approach to be taken in Agency guidance on how food businesses should control the risk of cross-contamination by E. coli O157 and how those delivering official controls can gain assurance that food business controls are adequate and effective.

What is the purpose of this consultation?
To invite stakeholder views on the principles to be applied in controlling the risk of cross-contamination by E. coli O157 in order to produce clear guidance for use by all relevant food businesses and enforcers. Information about the effectiveness, practicality and appropriateness of the measures, for food businesses and enforcers will help shape the form and content of the guidance which is under development.

The Report of the Public Inquiry into the 2005 E. coli O157 outbreak in Wales (see paragraph 5 for details) was published in 2009 and made a number of recommendations, to which the Agency is responding on a UK-basis. In relation to this consultation, the following are the most significant:

• Recommendation 1: All food businesses must ensure that their systems and procedures are capable of preventing contamination or cross-contamination of food with E.coli O157
• Recommendation 4: The principles underpinning the Butchers’ Licensing Scheme...should guide food hygiene measures in businesses processing raw meat and unwrapped ready to eat foods
• Recommendation 5: The Food Standards Agency should review its current guidance and should be proactive in generating new guidance where needs are identified
• Recommendation 6: The Food Standards Agency should remove the confusion that exists among food business operators about what solution(s) should be used to prevent cross-contamination from surfaces and equipment

E. coli O157 is a particularly dangerous organism due to:

• its very low infective dose that can cause serious illness and death
• its ability to survive acidic environments, refrigeration and freezing

Young children, the elderly and immune-compromised individuals are particularly at risk. While not exclusively meat-borne, the fatalities in Scotland (1996) and Wales (2005) were due to cross-contamination of food by E.coli O157 from raw meat in a butcher’s premises.

Key proposals:

• Every consumer needs to be protected from the risk of an isolated instance of low level contamination of food by E. coli O157
• The risk to consumers from premises handling raw and RTE food needs to be reduced by (1) physical separation, (2) cleaning and disinfection, and (3) hand washing and sanitisation. All three need to be achieved in order to reduce the risk
• The means to clarify how FBOs should control the risk of cross contamination by E. coli O157 and how those delivering official controls can gain assurance that food business controls are adequate and effective will be contained in guidance rather than legislation
• The guidance applies to all food businesses of all sizes and types handling raw and ready to eat foods
• Any lapse in cross-contamination control must immediately call into question the validity of the procedures that have failed and should call into question the ability of the FBO to continue to rely on current procedures

This consultation invites your comments on the principles that should inform the Agency’s guidance under development. Work thus far to develop the guidance has involved a review of the published material. It has been supplemented by discussion with the following external contacts:

• British Institute of Cleaning Science
• Suppliers and manufacturers of food manufacturing equipment (vacuum packers in particular)
• Campden BRI
• Independent food safety consultants and trainers
• The Health and Safety Executive

The guidance produced as a result of the comments we receive on the principles, will be subject to further consultation with interested stakeholders, focussing on the users of the proposed guidance.

Questions asked in this consultation:

1. Do you agree that the underpinning principle for the guidance should be that every consumer needs to be protected from the risk of an isolated instance of low level contamination of food by E. coli O157? If not, what alternative would you suggest?
2. Do you agree that the elements described in paragraph 9 a)-c) are an effective and proportionate approach for FBOs to controlling the risk of E. coli O157 contamination?
3. In particular, is achieving separation to the highest degree physically possible, including dedicated (single purpose) use of complex, hard to clean, equipment such as vacuum packers, mincers and slicers a proportionate response to the risk? If not, what alternative would you suggest?
4. Is the approach for authorised officers described in paragraph 11 proportionate, effective and clear? If not, what alternatives would you suggest?
5. We would intend to issue guidance based on these principles to provide clarity to FBOs and authorised officers, so that both can be clear about how to comply and how to address non-compliance. Do you agree that such guidance would be useful for FBOs and/or for authorised officers?
6. Do you have any views on the form or format that the proposed guidance should take? In particular, what would help in relation to the suitability and use of cleaning and disinfection materials?

Questions taken from the Impact Assessment:

The Agency would welcome views on:

1. Whether the suggested list of categories of premises likely to be affected is accurate.
2. The likely cost to businesses (with supporting evidence where possible) in terms of familiarisation with proposed guidance, the purchase of additional equipment to comply with physical separation and/or necessary changes to business premises to achieve complete physical separation of raw and ready to eat foods.
3. Whether it is agreed that large businesses are unlikely to incur significant cost in complying with the proposed guidance due to the existing nature of their operations.
4. Whether the estimated cost to local authorities is considered accurate or if there are any additional costs that will result from the proposed guidance.
5. Whether local authorities agree with the described benefits and/or consider that there will be additional benefits from the introduction of the proposed guidance.

We welcome comments from all stakeholders on this consultation. We are particularly keen to hear from small and medium food businesses to better understand how they would be affected by complying with the need for separation to the highest degree physically possible, including dedicated (single purpose) use of complex equipment. We would also welcome comments from those undertaking official controls in food businesses on whether guidance embodying the principles described above would enable them to (a) offer clear advice to food businesses to help them to comply; and (b) be clear about what constitutes non-compliance and the actions to be taken as a result. Please send responses either by email or in hardcopy to the contact shown at the top of this consultation.

Responses are required by close 5 October 2010. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk