National Farmers' Union Speech

Thank you for inviting me here today. I welcome this opportunity to share with you my thoughts about the FSA's general approach to risk and regulation and to bring you up to date on a major regulatory review we are currently undertaking, namely the Over Thirty Month Rule.

The Government should acknowledge that food, like everything else, is not risk free. Therefore we do not aim to regulate for zero risk.

This point was made by Lord Phillips in the BSE enquiry when he said: 'Government does not set out to achieve zero risk but reduce risk to a level which should be acceptable to the reasonable consumer.'

Regulation should be based on scientific assessment of risk, taking the best available independent advice.

However, often the scientific evidence is incomplete and leaves uncertainties. Therefore Government has to come to a judgement about how far to go in regulating risk when there are uncertainties. Sometimes this judgement is labelled the 'precautionary principle'.

To me, the precautionary approach, as I prefer to call it, means thinking about the scientific assessment of risk, the uncertainties in the science, the proportionality of risk management options and their acceptability to the public.

In some cases the way for Government to manage risks is to give people information and choice, in others it is to regulate.

In general, information and choice would seem more appropriate where the risks are voluntary, small, and well-characterised. Regulation is generally more appropriate for large, involuntary or uncertain risks.

For example, BSE in cattle was seen as such a potentially large, unknown and pervasive risk that regulation was the appropriate way to manage it.

On the other hand, the microbiological risks associated with drinking raw milk, whilst considered unacceptable by scientific experts, are seen as a case for individual choice and information.

At least in England and Wales. In Scotland the sale of raw milk is prohibited, underlining my point that precautionary action is in the end a judgement.

Giving people information and allowing them to choose should also involve being honest about uncertainties. Acknowledging what we don’t know is a rather new style of Government communication about risk. We have been very honest and open, for instance, about the uncertainty related to BSE and sheep. As far as we can judge from our consumer research, this style of honesty is helping to build trust and confidence in us as a regulator, and therefore ultimately in the food chain.

Unlike some other areas of regulation, it is difficult in food to set a fixed threshold of risk acceptability below which no regulation is required.

This is for two reasons:

• the risks are often not well enough characterised to quantify them in relation to a threshold;
• acceptability of risk in the eyes of the public varies. Risks that affect young children, for instance, like BSE, might be less acceptable.

It is sometimes said that the food industry is over-regulated. And that 'big industry' likes this because it drives small competitors out of business.

Partly as a result of this assertion, one of our first actions in the FSA was to set up a review of the Burden of Regulation of Small Food Businesses. Perhaps surprisingly, this review showed that food regulation itself is not excessive, but that the overall burden of regulation is a problem for small businesses.

Sometimes we are able to interpret the regulations to help small businesses without increasing risk.

For example, we have taken a flexible approach to the use of licensed cutting plants for farmers wishing to sell meat at Farmers Markets.

Here we considered that we could enhance consumer choice without compromising safety by allowing, under some circumstances, the use of butchers licensed under general food hygiene regulations.

Also we may be able to help small businesses to help themselves in meeting safety standards.

Our initiative with the specialist cheese manufacturers to introduce food hygiene training and implementation in a three-way partnership between businesses, enforcement officers and ADAS consultants has been widely welcomed.

Moving beyond regulation, I think that there is a very important role for voluntary action by industry.

In some cases this will go beyond the legal requirements, raise standards and thereby enhance consumer confidence in the food chain. We are strongly supportive of this kind of initiative.

For example, poultry producers have succeeded in reducing levels of salmonella contamination from 30% in the late 1990s to about 6% in our survey last year.

Egg producers have similarly worked to reduce salmonella and we will report the results of our survey later this year.

We are now working in partnership with poultry producers on the biggest food pathogen problem in chickens, campylobacter.

I am keen to see more partnerships of this type develop between the Agency and producers so that together we can deliver real benefits for consumers.

For example, I very much hope that growers will be prepared to work with us to minimise the occurrence of pesticide residues in the food they produce as consumers consistently tell us that this is what they want to see.

Some people think that we in Britain are more zealous than our colleagues in other countries within the EU in enforcing regulations. However, we must recognise that in their inspection visits, the EU's Food and Veterinary Office generally finds areas for improvement here as it does in other countries. We are probably more akin to Blackburn Rovers than to Arsenal.

As I said in the Sainsbury City Food Lecture last month, I think there are significant challenges associated with EU enlargement and the requirements of accession states to meet European standards, as well as policing their borders.

As you know we are currently reviewing the OTM Rule. And considering whether or not it should continue.

When we reviewed the BSE controls in 2000 we recognised that the OTM rule was one of the key controls in protecting public health.

It keeps almost all animals close to clinical BSE (and therefore with infectivity) out of the food chain. Almost all residual risk is removed with SRM controls.

As you will know the OTM rule was introduced in 1996 as a pragmatic, rough and ready solution.

SEAC had actually recommended the deboning of older animals but impracticality of this led to the OTM rule.

Thirty months is not a magic number.

It was chosen because:

• few animals develop the clinical stage of the disease by this age, even if they are infected
• it is possible to age (approximately) animals by their teeth – as a check on documentary evidence.

In our 2000 review we said that the OTM rule should be revisited and reviewed in 2002, in light of evidence of declining incidence of BSE.

Meanwhile, since 1 January 2001, EU-wide BSE controls have been introduced, and other countries test older animals (over 30 months by requirement and in some countries over 24 months on a voluntary basis).

The Commission is now asking why we are not adopting this EU wide regime.

They are particularly concerned that we apply the OTM rule to imports from other EU countries, restricting their export market to us.

Against this background, let me tell you where we are in our review. We are not at the stage of coming to a final view, so I will talk about the process and the factors we are considering.

We kicked off our review with a public meeting last summer where a range of views were aired and discussed.

Following this we set up a core stakeholder group including industry, consumers, scientists and policy experts.

This group, which I chair, has met seven times and will meet twice more before the end of March.

We aim to produce a report to go out to formal consultation in late March.

Before this we will hold a wider stakeholder meeting, in public, in London on March 7, to allow further views to be discussed.

We also set up a scientific risk assessment group chaired by Peter Smith, chair of SEAC.

This group reports to the core stakeholder group. Its job is to do the best possible assessment of risk and how risk might change if the OTM rule is altered.

Alongside this risk assessment, the core stakeholder group has to consider the practicality of alternative options, their proportionality to risk, and the legal dimension, including both EU requirements and the implications of devolution – and crucially, consumer confidence.

Let me say a few words about each of these aspects.

First: risk.

The expert view is that we are now at the tail end of the BSE epidemic.

It is estimated that more than 10,000 of the highest risk animals a year were going into the food chain at the peak of the epidemic as compared to less than one today.

In addition the specified risk controls are now tighter, removing an estimated 95% of the residual risk.

This means that the overall risk has diminished hugely.

However, we must also recognise that there are considerable uncertainties in the risk assessment.

For instance, we don’t know why animals born after the complete feed ban (August 1996) are still developing BSE and how long this will continue for.

The risk assessment experts are quantifying the risks. But they acknowledge that their quantification involves making numerous assumptions.

We do not yet have the final results but it is possible that the risk assessment will indicate that:

• the relative risk today is small compared with even the recent past (say the late 1990s)
• changing from the OTM rule to another regime involving testing may result in a marginal increase in risk
• there may be only small differences in change of risk for different options

I emphasise these are not conclusions but possible outcomes of the risk assessment.

What kind of options are being considered?

Any change in the OTM would mean that animals over 30 months would have to be tested (as in the rest of the EU) before entering the food chain. One approach would be to allow animals born after a certain date to enter the food chain. Another would be to switch completely to testing.

Let me now say a bit about practicalities.

If we move to a testing regime the implementation of industrial scale testing and the necessary quality control will have to be in place.

Since other countries have done this, it should be feasible for us.

A new regime could place more reliance on passports, without the ageing by tooth eruption of the OTM scheme.

The British Cattle Movement Service acknowledge that there are passport discrepancies for 10% of cases checked and that the software for fraud checks is not yet in place.

On the legal side, clearly the Commission preference would be for us to switch to the EU regime as soon as possible.

What about proportionality?

There is an argument that says if the risk has declined very greatly (as it has) then what was a proportionate risk management approach a few years ago is now over precautionary.

The current regime costs the taxpayer over £400 million per year and the alternative of testing would cost much less. Thus there would be general benefit to the public of changing the regime, to be weighed against what may be marginal or almost imperceptible increases in risk.

With BSE there are still many unknowns and uncertainties that make this judgement more difficult.

Finally, the key issue of consumer confidence.

Everyone accepts that human BSE is a terrible and tragic disease.

And it has all the dread factors that elicit heightened perception of risk:

• irreversible
• unknown
• mainly affects young people
• not under our individual control

So the public expects, rightly, a highly precautionary approach.

If the rule is to change and public confidence is to be maintained, several things need to happen.

Communication is key:

• the risk is now much smaller
• testing is a valid alternative
• the controls for traceability and implementation are tighter than ever
• the industry will play a full and responsible role in ensuring the new system is robust

And, of course, the SRM controls will remain in place.

And all of these issues must be debated publicly and honestly to bring all our stakeholders with us.

To conclude, for you the issue for your survival is not just how much you are regulated, but how effective you are in building and maintaining consumer confidence. This is something we can work on together in an honest and open way.