The Pennington Group

Report on the circumstances leading to the 1996 outbreak of infection with E.coli 0157 in Central Scotland, the implications for food safety and the lessons to be learned.

Chapter 4 The Hazard Analysis and Critical Control Point (HACCP) System

4.1 We spent a lot of time considering the HACCP system. There are many references to it throughout this report, as the overarching system which governs the UK's (and indeed the emerging global) approach to tackling food safety issues. This chapter therefore examines the concept and our view of its relevance and effectiveness in tackling the challenges posed by E.coli O157.

Background

4.2 HACCP is a structured approach to analysing the potential hazards in an operation; identifying the points in the operation where the hazards may occur; and deciding which points are critical to control to ensure consumer safety. These critical control points (CCPs) are then monitored and remedial action, specified in advance, is taken if conditions at any point are not within safe limits. HACCP is both a philosophy and a practical approach to food safety.

4.3 European Union (EU) food law places the responsibility for ensuring the safety and protection of the consumer very firmly with individual food businesses. HACCP based principles, some of which are enshrined in much of this law, provide the tool for food businesses to address this responsibility and these principles are backed up in law by prescriptive requirements and provisions requiring enforcement. The advantages of the HACCP approach are now internationally recognised, through the Codex Alimentarius Commission⁹, where it is agreed that HACCP is based on 7 principles:-

1. Conduct a hazard analysis. Identify the potential hazards associated with food production at all stages up to the point of consumption, assess the likelihood of occurrence of the hazards and identify the preventive measures necessary for their control;

2. Determine the critical control points. Identify the procedures and operational steps that can be controlled to eliminate the hazards or minimise the likelihood of their occurrence;

3. Establish critical limit(s). Set target levels and tolerances which must be met to ensure the CCP is under control;

4. Establish a system to monitor control of the CCPs;

5. Establish the corrective actions to be taken when monitoring indicates that a particular CCP is not under control;

6. Establish procedures for verification to confirm that the HACCP system is working effectively; and

7. Establish documentation concerning all procedures and records appropriate to these principles and their application.

4.4 With certain exceptions (eg the red meat and poultry meat directives) EU (and hence UK) food hygiene legislation requires food businesses to undertake "own checks" based on some of the HACCP principles (notably hazard analysis). Implementation of the full range of HACCP principles is not, however, a legal requirement. Indeed differing requirements in a range of food legislation introduce further confusion. There is a lack of consistency in requirements among "vertical" regulations (that is, product specific regulations which set out the requirements for dealing with the product throughout the production process) and between these and "horizontal" regulations (which apply to the wide range of premises not covered by the vertical regulations).

4.5 From the evidence we have heard, it is clear there is confusion about the application of HACCP both in a practical and legislative sense. HACCP, HACCP principles, hazard analysis and risk assessment are terms which seem to be used interchangeably and may be misinterpreted. Hazard analysis is the term used in Government guidance to describe the requirements, again based on HACCP principles, contained in the horizontal regulations. Risk assessment is the important first step of the HACCP philosophy.

4.6 Terminology used to describe the application of HACCP or (some or all of) the HACCP principles can also be confusing. For clarity, references in this report to HACCP mean the approach adopted by Codex Alimentarius and all 7 of the principles set out in paragraph 4.3.

The Group's Views

4.7 We endorse whole-heartedly the implementation of HACCP. We believe there is a particular need to raise the level of awareness of, and expertise in tackling, the hazards involved in food handling and production. The most effective way of minimising risk must be to influence the attitudes of all those involved throughout the food production process and to ensure that they take appropriate personal responsibility for the adoption of good practice in food handling and hygiene. We have had reports of its impressive effect in other countries. We therefore accept entirely that HACCP should underpin the approach to food safety at all stages of the food chain.

4.8 Since the relevant directives (and therefore domestic legislation) do not require implementation of HACCP, the implication of this is that the directives will require to be renegotiated. Meanwhile, a start can be made to the process by fully implementing those of the HACCP principles that are enshrined in legislation.

4.9 Moreover, the successful application of HACCP requires the full commitment of management and the workforce. It also requires a multi-disciplinary approach. A prerequisite to implementation is knowledge, understanding and expertise in identifying the hazards and assessing the risk involved in an operation. Introduction of a new system requires structured implementation. From information and evidence we collected during the course of our work, we identified a number of concerns about relying on HACCP principles in the short term as the means to protect public health:-

the scheme relies primarily on businesses themselves, albeit with external expert advice and assistance as appropriate, to identify potential hazards and critical control points within their own operations;
businesses require expertise and training for successful implementation;
as Government department literature itself recognises, many businesses have yet to discover HACCP, or to put it into practice. The concept is sound, but it is relatively new and as yet insufficiently well known or understood - across the spectrum of issues involved or of business;
the period over which HACCP principles can effectively be introduced is lengthy (senior enviromental health officers (EHOs) with first hand knowledge and experience of food premises, and individuals involved in education and training in food safety, suggest that this will take up to 5 years or even longer, regardless of the risks inherent in a particular business). As recent events have shown, there is the potential for many, serious outbreaks of food poisoning over that period;
enforcement of those of the HACCP principles and practices which have been enshrined in horizontal legislation has, at the request of Government, been pursued generally with a light touch, based on a "graduated approach". Indeed there has been a 12-month period of grace set out in statutory Codes of Practice for enforcement of the hazard analysis requirements of the 1995 Regulations. We believe that approach can no longer be considered appropriate or acceptable;
there is concern that enforcement of the hazard analysis requirements of the 1995 Regulations may not be effective;
enforcement under the 1995 Regulations is by prosecution and takes time;
if public health is considered to be at risk due to defects in the hazard analysis, emergency action needs to be taken under the Food Safety Act 1990; and
in this case, the court needs to be satisfied that the health risk condition has been fulfilled. (This is discussed further in Chapter 9.)

Interim Findings

4.10 In producing our interim report we concluded that measures are needed to reinforce existing legislation, to strengthen the impetus on implementation and enforcement of HACCP principles in the short term and to promote food safety pending their full implementation. We made a number of recommendations towards that end, including:-

the inclusion of new, improved guidance on risk assessment in Codes of Practice on Food Safety;
acceleration of the implementation of HACCP for high risk premises;
a review of existing guidance on cross-contamination;
better targeting of Environmental Health Departments' resources, including more frequent inspections of high risk premises;
amendment to the definition of the health risk condition contained in Section 11(2) of the Food Safety Act 1990 (to permit food authorities to have greater confidence to take enforcement action if they feel they have reasonable evidence that particular food premises represent a risk to public health);
the separation of raw meat and cooked foods in target premises; and
the introduction of selective licensing for high risk premises (ie butchers and producers who are handling raw and cooked meats) to permit more detailed conditions to minimise health risks to be set and enforced. This was seen as a short term measure whilst HACCP systems are being introduced.

4.11 In considering these issues, we recognised and understood the Government's general policy presumption against prescription and in favour of deregulation to reduce the regulatory burden in small businesses. In the case of food hygiene, the Government's aim has been for simple and proportionate legislation that does not dilute the overall level of public health protection. We felt, however, that the need to promote safety in food production and to safeguard public health has to be accepted as a special case where the balance requires a greater degree of prescription.

Final Recommendations

4.12 The principles and implementation of HACCP, and a number of the issues and preliminary recommendations set out above, have been the subject of a great deal of discussion and debate since publication of our interim report. The issues are discussed further in the context of final recommendations set out in Chapters 7 and 9.

9 See Glossary.