'Safety margins have been grossly eroded

The baby milk alarm has shown yet again that this Government can't handle issues of public health. Geoffrey Lean spells out the facts behind last week's fudge and suggests how confidence could be restored been grossly eroded'
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The Independent Online
"If we say things are safe, that is what we mean."

Thus Tim Boswell, the junior agriculture minister, on the radio last Monday. His intention was to assuage concern at the revelation that what he admitted were "undesirable" levels of chemicals which may impair human fertility had been found in baby milk. Instead, a drama became a crisis.

It became embarrassingly clear that the country no longer believed the assurances of ministers that they could be trusted to look after children's health. And, as they repeatedly refused to name the affected brands, the conviction grew, as even the Sun put it, that they were "putting big business before tiny babies".

"We are in the business of being open with the public - giving them the facts which are relevant," continued Mr Boswell. "I'm not sure the public wants a series of scientific print-outs on particular brands."

LEAVING aside the fact that parents were clamouring for precisely such information, this was an extraordinary confirmation that, despite 17 years of government rhetoric, the Nanny State is alive and well and living on the back seat of ministerial limousines.

And it chimed oddly with ministers' eagerness to publish league tables - such as those for hospitals and schools - in the name of aiding consumer choice. The harsh disciplines of open-market competitiveness were just what was needed for teachers and nurses, it seemed, but they could not be inflicted on a pounds 134m-a-year industry.

Perhaps Mr Boswell, a hitherto little-known farming MP, was unprepared. The day before, after the Independent on Sunday revealed that government scientists had found phthalates in baby milk at levels worryingly close to those that shrank the testes of laboratory rats, BBC Radio had tried to find an agriculture minister to comment - but in vain. Even the next morning, the Today programme initially had to announce that it, too, had been told no minister was available. It was only an hour later - when it was clear that the Government was suffering damage - that Mr Boswell materialised on air for the first of his calamitous interviews.

It was a fitting start for what was to be a week of bungle and bluster, and of mounting anxiety and anger. Mothers jammed baby-food manufacturers' helplines, seeking information the Government denied them. Organisations from the British Paediatric Association and the Consumers Association to the Royal Environmental Health Institute of Scotland condemned the Government's persistent refusal to provide the facts.

The Royal College of Nursing said that "nurses felt seriously let down by the lack of information". The British Medical Association spoke of parents' "right to know the facts, so that they can choose milk that is safe". The Daily Mail said people wanted "less preaching from Mr Boswell and more openness from this inept and woefully unconvincing government". And even the baby-food industry, which ministers were trying to protect, concluded that, through secrecy, "the Government has probably created more anxiety over this issue than it need have done". The end of the week

brought help from a most unexpected corner. The European Union - which ministers have spent the past fortnight denouncing and obstructing over the beef ban - judged that "there is no imminent danger for babies". And - humiliation of humiliations - it was only when these reviled "Brussels bureaucrats" gave their verdict that public anxiety began to abate.

In fact - despite Mr Boswell's self-confidence - neither Brussels, nor Whitehall, nor the manufacturers, nor the environmentalists can possibly know how safe or dangerous are the levels of the chemicals found in the baby milk. Too little is known about the hazards of the substances - clear, oily liquids, millions of tons of which are added to plastics each year to make them more flexible. "Tolerable" levels have not even been set for most of them, and those that have do not take into account their potential impact on fertility.

What is certain is that the normal safety margin for a harmful substance between what is allowed for humans and what has been shown to damage laboratory animals has been grossly eroded. It is also clear that the Government has learned nothing from the past. A leading Tory acknowledged thatits handling of the issue had "echoes of the early days of BSE".

Two months ago, on the Sunday after the Government acknowledged a possible link between mad cow disease and CJD in humans, I wrote: "Perhaps ministers and their advisers will learn from the BSE fiasco. But don't bet on it. Bet instead on a similar culture of denial over the next emerging big threat, a decline in male fertility from the widespread use of chemicals that mimic the effects of oestrogen. We should see early evidence of the Government's attitude on this some time next month." I got it wrong - by a month.

IT ALL started very simply. The facts - as we reported last week - come from the Ministry of Agriculture's own partially published research. They have not been disputed.

Researchers at the Ministry's CSL Food Science Laboratory in Norwich tested samples last year from 15 brands of baby milk bought in shops in five towns across Britain. Nine "market-leading" brands were tested by themselves; six others were combined in pairs for analysis, apparently to save money. The ministry reported: "Phthalates were detected in all samples of infant formula that were analysed."

The scientists went on to estimate that, on average, a newborn baby would receive each day 0.13 milligrams of all the phthalates in the milk put together for every kilogram of its weight. They also recorded that researchers at the Medical Research Council and Brunel University had found that levels of one of the phthalates in the milk - butylbenzyl phthalate (BBP) - starting at 0.1 milligrams per kilogram of total body weight administered each day has caused male laboratory rats to develop with smaller testes and reduced sperm production.

These figures for babies and rats are uncomfortably close, but not strictly comparable, as the rats were exposed to only one phthalate while bottle- fed babies receive several kinds. Some of the other phthalates may be less harmful than the one that damaged the rats, but experiments suggest some, at least, also affect reproduction.

To get a better idea of the relative danger, the ministry's scientists concentrated on the two phthalates in the baby milk that most clearly seem to mimic the effects of oestrogen - BBP and dibutyl phthalate (DBP). When it added the amounts of these two in the milk together they found that for the worst of the brands, codenamed W1, a newborn baby would receive each day 0.0227 milligrams of the phthalates per kilogram of bodyweight, or just under a quarter of the lowest dose that affected the rats. For the least contaminated sample, codenamed C3, he or she would receive each day 0.003 milligrams per kilogram, a 33rd of this dose. All the other samples ranged between these two extremes.

This means that every sample violated the safety margin normally laid down for potentially harmful substances: that human exposure should not exceed 1 per cent of the lowest level found to affect laboratory animals. This margin allows for the possibility that humans may be more susceptible to particular substances than the animal; and it allows for a wide range of susceptibility within species.

The scientists' calculation does not appear to allow for the possibility that other phthalates have similar effects: if any do, the safety margin will narrow even further. And some are likely to do so. Studies in Britain and Sweden suggest the phthalate most abundant in the baby milks - di-(2-ethylhexyl) phthalate (DEHP) - may also mimic oestrogen, if more weakly.

After studying the research, Ministry of Agriculture officials secretly met baby-milk manufacturers to get them to trace the source of the phthalate contamination. So far, no one knows how it gets into the milk.

The facts may be clear enough, but last week they became surrounded by obfuscation, echoing the handling of similar issues in the past and boding ill for their treatment in the future. Often the statements of the industry and the ministry seemed more designed to mislead than to illuminate.

Take, for example, the Tolerable Dose Intakes (TDIs) for phthalates, set by the EU, which were constantly paraded by both the industry and the ministry - and often misleadingly called "safety limits". Baby-milk firms were insisting that the amounts found in the milk were "well below" the TDIs, while the ministry said they were "slightly above" them. Despite the contradiction, the TDIs dominated the debate over safety.

In fact they are largely irrelevant. Only five phthalates have had TDIs fixed for them, and all but one of these are described as "temporary". More important, as the ministry admits, they were all set "before the recent findings that some phthalates may have oestrogenic activity". In other words they do not take into account the chemicals' gender-bending potential, which is what the concern is about.

Then there was the assertion - trotted out, as so often in the past in the early days of the asbestos, lead-in-petrol, PSE, HIV in blood transfusions and other controversies - that there is "no evidence" of harm to humans. This was elegantly described last week by Dr Thomas Stuttaford in the Times as "a latter-day equivalent of the Victorian GP's humming and hawing by the bedside while he waits to see what nature will do next. What it means is that the doctor doesn't know, hopes for the best, and meanwhile will continue to investigate." He added: "Faith in the phrase, and the inertia that it induced, has cost Britain's beef industry dear, jeopardised good international relations with the rest of Europe and almost certainly cost some - one hopes comparatively few - human lives."

The demand for proof, also much heard last week, is a more cynical variant of this theme. There are only two ways of obtaining proof of damage to babies. One would be to experiment on them, giving them phthalates and seeing what happened. The other would be to conduct a study comparing the eventual fertility of babies fed by bottle and breast, a process lasting decades. Both, presumably, would be unacceptable even to those who loudly demand proof.

The word is used in this context as in a criminal court, that a substance should be regarded as innocent until guilt is proven. With chemicals whose effects take decades to become evident, such an approach risks enormous damage before "proof" is established. Some environmentalists retort that all chemicals should instead be presumed guilty until proved innocent, an attitude that would have prevented many important scientific advances, including medical ones. A more sensible approach, now gaining ground in international law, is to adopt the standard of proof required in civil court cases and take action when "the balance of probabilities" suggests it. Sources of phthalates are already being phased out, on this basis, in Sweden and Switzerland.

In reaching this judgement there is ample room for weighing scientific differences in interpretation of the kind we saw last week. Dr Richard Sharpe, of the government's Medical Research Council (who had told me when I was researching the original story that he was "not necessarily the best person to give you the real bottom line on this") went on television to give his view that there was no cause for concern. But Professor John Sumpter of Brunel University, who had co-authored the paper on the effects of phthalates on rats with Dr Sharpe, earlier expressed his concern at the narrowing of the safety margins.

There were also familiar charges of "scaremongering". The claim by baby- food manufacturers that the row was being fuelled by "misleading reports" echoed the asbestos industry's insistence in the heat of the controversy over its product that "fears have largely stemmed from sensational news features": diseases caused by asbestos are about to overtake road accidents as the major cause of premature death in Britain.

In fact, last week's reporting, even in the popular press, was remarkably sober. Newspapers almost entirely confined themselves to printing the facts of the research, the reactions of concerned parents and organisations and the official reassurances. The official line on safety was hardly challenged; where the Government was taken to task was over its refusal to name the affected brands.

If last week's crisis was fuelled by the way ministers handled it, and by a lack of trust in their pronouncements, the question arises: is there a better way of handling such issues?

TACTLESS though it may be to say so in such xenophobic times, ministers and the industry could have learned a thing or two from how Perrier reacted when traces of benzene were found in its water six years ago.

Even though the US government, which found the potentially cancer-causing chemical, said there was "no threat to human health", the French company withdrew its water from the market, only returning it when the problem was eliminated. It took a temporary blow, but quickly regained market leadership - and the following year announced sharply increased profits.

The point is not that baby milk should have been removed from the shelves (where would that have left parents and their children?), but that Perrier benefited by taking rapid and vigorous action to restore confidence. Contrast that with the sorry history of BSE, asbestos, lead in petrol, HIV in blood, and many other sagas where British ministers have been dragged along kicking and screaming by public concern before finally conceding that they were wrong.

Much of the problem over BSE and baby milk is that the Ministry of Agriculture is responsible both for the safety of food and for promoting the industries that produce it. Both main opposition parties now propose creating a separate food safety agency, independent of government, as the US has. Ministers reject this, preferring what they call "good and constructive links with the producers". The ministry even pooh-poohs proposals for creating an independent body of scientists, explaining, in a revealing sentence: "We regularly use scientists who work for food companies because they are the only people who can make the judgements we need."

Nevertheless there is a successful Whitehall precedent for just such an agency. For years the old water authorities were both Britain's main river polluters and responsible for policing pollution. When water was privatised, the independent National Rivers Authority (NRA) was set up. Now part of the Environment Agency, the NRA has had spectacular success in tackling pollution. Last week it announced that river pollution incidents had dropped by 70 per cent since it came into being in 1990.

If an agency with that kind of credibility were monitoring British food safety, there is a good chance that the baby-milk crisis - and the BSE crisis - would have been solved long ago. Who knows, it might even be possible for agriculture ministers to pronounce on the issue without causing nationwide alarm.