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LAST SUMMER, conflict loomed with the US over European reluctance to
approve the use of a hormone, bovine somatotropin. BST increases milk production
in cattle, and the US plans to approve it.

The European Commission has just brought the Community’s milk lake under
control, and is uncertain whether it wantsto approve a hormone that boosts
milk production. In September it deflected confrontation with the US by
postponing its decision on BST for an ‘evaluation period’ of one year.

The commission is currently trying to decide what to say next October.
If it comes out against BST, the US and the chemicals industry will howl.
If it decides for BST, many European groups, from small farmers to Green
parties, will not be pleased. And the decision will set a precedent for
the regulation of new agricultural technology, especially biotechnology.

Two issues are at stake, both involving questions about the type of
evidence regulators need to judge new technology. The first is whether a
new technology should be approved purely on the basis of effectiveness,
whatever impact its introduction will have on the industry concerned. The
second concerns the science itself: who decides whether a new project really
is safe and effective? Whether to take BST’s impact on farmers into account
is the most pressing problem for the commission’s committee on veterinary
medicinal products, which governs animal drug licensing in the Community.
Traditionally, the three pillars of drug regulation are quality, safety
and efficacy. A company must present scientific evidence that it can produce
the drug with reliable quality, that the drug does what it is claimed to
do, and that it can be used safely. If those requirements are met, the drug
must be licensed.

The problem for the commission is that BST boosts milk production. Europe
has only recently, through rigorous quotas and controls, eliminated the
worst of its milk glut. Europe’s dairy farmers are not allowed to boost
their production. Monsanto – one of the two companies producing the hormone
– replies that BST can even out production, allowing cows to produce the
full quota during periods when their output would otherwise fall.

This could well be an advantage for some farmers. But several studies
suggest that the advantage will favour large-scale dairy operations over
small farms. BST turns a cow’s metabolism more completely over to milk production,
possibly leading to neglect elsewhere. In several scientific trials funded
by chemicals companies, cows on BST have shown increased mastitis, or udder
inflammation, decreased fertility and symptoms of stress. Economies of scale
make veterinary help more affordable on big farms, and BST, therefore, easier
to introduce and manage.

The European Community spends billions of pounds every year to buy European
farm produce – including milk – at higher than world prices, so that European
farmers can stay in business despite more efficient competition elsewhere.
The commission is especially anxious to keep small farms in business, for
reasons that range from a desire to maintain rural communities, to the political
clout those farmers wield in several countries, especially West Germany.

BST, by increasing milk production and favouring bigger farms, appears
to go directly against the European Commission’s hard-fought efforts to
control Europe’s dairy industry. This increases the appeal of adding economic
and other policy considerations to quality, safety and efficacy in deciding
whether to license BST. The European Commissionerfor Agriculture, Ray McSharry,
raised the possibility of this so-called ‘fourth hurdle’ when he announceda
moratorium onapproval of BST in September.

There are legalprecedents. Article 43of the Community’s Treaty of Rome
allows agriculture ministers to consider economic factors in adopting technical
innovation. In deciding that the commission was entitled to ban the use
of steroids to fatten meat animals, for example, the European Court ruled
that opposition from consumers was enough to warrant the ban, even if meat
from treated animals could be shown scientifically to be safe.

It is not clear whether Europe’s consumers will object to BST-treated
milk. Monsanto has helped to fund a study in southeast England by the Milk
Marketing Board, which, according to staff at the commission, revealed no
difference in consumer preference for milk from BST-treated or untreated
cows. In the American dairy-producing state of Wisconsin, however, protest
from farmers’ and consumers’ groups against the marketing of milk from trials
with BST has become so vocal thatthe state is expected to pass a bill nextmonth
requiring labelling for BST milk. InAugust, four American supermarketchains
announced they would not sell it.

Similar pressure is now being mounted by consumer groups in West Germany
and Britain. The consumer issue may eventually be decided by a directive
on labels for produce from ‘organic’ farms now being drafted by the commission.
This would give consumers a choice between food produced with and without
artificial chemicals such as BST. Given the possibility of choice, consumer
opposition might cease to be a legal argument against approving BST.

The US is already making it clear that, while it backed down over steroids,
it is prepared to fight if Europe bans the sale of American meat and milk
from cows treated with BST. One reason is that the companies that make BST
are American. Another is that, as one of the world’s largest food exporters,
the US is keen to introduce biotechnology to increase productivity, and
fears a ban on BST in Europe will fuel anti-biotechnology pressure at home.

The US is also afraid that if the products of biotechnology are stringently
regulated in Europe, it could damage a large number of potential American
exports. In a letter in October to Martin Bangemann, the European commissioner,
not for agriculture, but for trade, the US Mission in Brussels notes that
‘we have seen already in the case of bovine somatotropin that different
approaches to the regulation of new products of biotechnology have the potential
to engender bilateral trade issues between the US and the European Community.
We would hope to avoid repeated product-by-product disagreements.’

The US does not want fourth hurdles. ‘It is clear,’ says the letter
to Bangemann, ‘that our regulatory decisions (must) be based on the well
established and respected criteria of quality, safety and efficacy. These
criteria must remain utmost in our minds as we usher in new technologies.’

Britain agrees. The junior agricultureminister David Curry said in parliament
last month that, while the social and economic implications of BST are ‘important
questions’, they should be dealt with through agricultural production and
marketing policies, and not by adding them to the criteria for approving
new technology.

The companies are violently opposed to any fourth hurdle. They describe
any criteria other than quality, safety and efficacy as subjective, unscientific
and political. Neil Craven, head of animal sciencesfor Monsanto in Britain,
says it is ‘important . . . that the decision taken at the end of the evaluation
period (next October) is the right one, and not merely politically expedient’.

But apart from fourth hurdles, questions are being raised about how
well BST satisfies the existing three. The companies say that extensive
tests have shown BST to be safe and effective. Samuel Epstein, consumer
activist and professor of environmental and occupational medicine at the
University of Illinois in Chicago, argues that research to prove this has
not been done. His views are being taken into consideration at the commission,
and are due to be published, says Epstein, in a peer-reviewed journal.

Epstein says the basic issue is who controls safety research. ‘Institutions
with an economic interest in the outcome of trials must be suspect until
proven otherwise,’ he says. Companies, he claims, ‘suppress, manipulate
and distort’ data and this is ‘endemic to the whole current method for generating
information’ needed by regulators.

He identifies two areas of particular concern: BST’s effects on animal
health, and health effects on humans of the milk they produce. Epstein charges
that adverse effects of BST on animals have not been tested in trials designed
for the purpose, but have been noted incidentally in trialsdesigned to measure
milk production,then ‘trivialised and discounted’. He saysrecent data from
North Carolina StateUniversity show 17-per-cent increases inintervals between
oestrous periods indicating that BST-treated cattle lose fertility. Other
studies, he says, also show cattleare under stress on BST.

This could harm humans, says Epstein. Stressed cows could secrete large
quantities of ‘stressor’ hormones such as adrenalin in their milk, and he
says this has not been tested. Cows may also become immunosuppressed, leading
to activation and secretion into milk of viruses, including bovine immunodeficiency
virus. This is related to HIV and capable of infecting chimpanzees.

Epstein says that none of these concerns has been investigated scientifically,
and his queries to the companies involved have been rejected without supporting
data. He calls the 22 dairy science departments of universities in the US
and Europe whose research is supported by the two companies involved ‘indentured
academics’. ‘I don’t know of any research’ not funded by the companies,
he says, except that of David Kronfeld in Philadelphia, one of the discoverers
of BST, whose work, he says, is rejected by the companies.

Kronfeld observed in the 1950s that fragments of somatotropins can alter
nitrogen metabolism in people who eat them. He wants research done on the
occurrence and effects of such fragments in the milk of cows treated with
BST. In October, scientists from Monsanto told a meeting in France that
fragments of BST have ‘no biologic activity in vitro’; and that fragments
have ‘less than 1 per cent’ of the same activity as BST in animals.

This is not the same as measuring the presence, and all activity, of
fragments that may occur in milk from treated cows, but the authors conclude
that ‘there is no reason to believe that small peptides derived from BST
would possess somatotropin activity, and their consumption in nanomolar
amounts’ would pose a risk to humans.

Epstein complains that the companies have never published the sensitivity
of their tests for natural versus recombinant BST in milk. He fears that
much of the hormone in milk may be the recombinant molecule. Craven says
the test cannot distinguish between natural and artificial hormone. Epstein
fears that the artificial hormone, whose composition differs from the natural
one by about 3 per cent, may harm humans at those levels in milk. It might,
for example, cause allergies.

Meanwhile, the debate in Europe over BST is likely to focus on its social
impact, opening up political wrangling over further products of biotechnology.
Porcine somatotropin, the protein that releases growth hormone in animals,
and vaccines against the switch that turns growth hormones off, are all
coming up for regulatory consideration in Europe.

Mark Cantley, of the European Commission’s biotechnology unit, says:
‘The first agricultural product of biotechnology may certainly not be ideal,
and science will certainly continue to make mistakes we will learn from.’
But, he says, we need biotechnology to produce enough food for a growing
human population, with minimal environmental degradation.

The fear in the pharmaceuticals industry is that the problems of BST
will cast a pall over the products of biotechnology in general. Epstein
says he is not against biotechnology; he simply wants to see the science
done properly and its products regulated carefully. Regardless of the rights
and wrongs of one hormone, drug approval in Europe is unlikely ever to be
free of ‘political’ considerations. ‘In the end, it could be more a question
of bottle than of milk,’ says Craven from Monsanto. Europe will find out
next October.

* * *

Genetic engineering comes to the dairy

BST is a protein hormone with several metabolic effects including the
promotion of growth in young animals (¿ìè¶ÌÊÓƵ, 24 March 1988). In
lactating cows, it increases milk production. Since it is a protein, it
can be produced in commercial quantities only by means of recombinant DNA.

The process is simple: the gene for the hormone is taken from the cow
and inserted into bacteria, which then produce large amounts of the protein.

Two companies are applying to market BST in Europe: Elanco, an American
consortium led by Eli Lilly, and Monsanto, another American company. Both
products are slightly different from the natural hormone.

BST is the first major product of genetic engineering to be offered
to farmers. This in itself gives it a high profile.

On one hand, the protein hormone has provoked concern about the applications
of biotechnology from several political pressure groups. These include a
number of consumer groups, including Britain’s National Farmers’ Union and
animal welfare activists.

On the other hand, chemicals companies insist that BST is the first
inwhat could become a long series ofnew products of biotechnology that would
mean new industries and jobs in Europe. If the new technology is unfairly
censured, the companies threaten to move elsewhere.