Truth About Trade & Technology  [Printer-friendly version]
August 16, 2005

PLEASE BE CAREFUL

[Rachel's introduction: This sophisticated attack on the
precautionary principle says it will undermine democracy, restrict
trade, and increase baseless government regulations.]

By Gary E. Marchant and Kenneth L. Mossman

Killer cranberry juice? Toxic corn flakes? Hazardous energy drinks?
Only under a loose concept known as the precautionary principle, which
has swept across Europe.

This precautionary principle gives regulators broad authority to err
on the side of safety and puts the burden of proof on the proponents
of a technology to prove its safety. The European Union officially
adopted the precautionary principle in 1992 as a binding legal
requirement for all health, safety, and environmental regulatory
decisions. Most recently, the French Parliament in February
incorporated it into the French national constitution.

The concept of the precautionary principle may sound relatively
innocuous. Who can argue against being safe rather than sorry? But the
idea is flawed in theory and practice, and the enshrinement of the
precautionary principle sets Europe down a path that will wreak havoc
on the economy and public health of not only itself but also its
trading partners.

For example, the European Union and its member nations for the past
six years relied on the precautionary principle to justify a de facto
moratorium on the approval of any new genetically modified foods -- a
moratorium that has only recently, slowly, and grudgingly begun to be
relaxed. Even though its own scientific advisers had found that
genetically modified foods have no known risks and are probably safer
than conventional foods, the European Union prohibited genetically
modified foods based on the precautionary principle.

The U.S. government says that this EU ban costs the United States $300
million per year in lost food exports, and it has filed a legal action
against the moratorium under international trade laws. The World Trade
Organization is expected to issue an initial ruling by the end of this
year.

FLAWED BY DEFINITION

More generally, the precautionary principle suffers from at least
three major intellectual flaws.

First, there are dozens of formulations of the principle promulgated
by regulators, courts, academics, and nongovernmental organizations in
the European Union and elsewhere. These formulations differ in
important details, such as whether and how costs should be considered,
whether all risks or only "serious and irreversible" risks raise
concerns, and what steps a product manufacturer must undertake to
satisfy the principle. There is no single or official version of the
precautionary principle.

Yet the European Union purports to apply "the" precautionary
principle. The Treaty of the European Union, as amended in 1992,
states simply that "community policy on the environment... shall be
based on the precautionary principle." The ambiguity resulting from
this failure to specify which version of the principle is to be
applied opens the door to its arbitrary application.

Second, most versions of the precautionary principle fail to give
adequate weight to scientific evidence or consideration of costs and
trade-offs. Some precaution is prudent and indeed essential for all
environmental, health, and safety regulation. But too much precaution,
especially if it ignores the financial costs, opportunity costs, and
risk trade-offs of excessive regulation, can result in unreasonable
decisions that do more harm than good.

Finally, the precautionary principle provides no limits on the
application of precaution, in that it provides no risk targets or safe
harbors that could exempt a product from further precautionary action.
As such, the principle could theoretically be applied to prohibit any
or every product or activity, since it is impossible to prove zero
risk for anything. Yet, obviously, the precautionary principle will
not be invoked to ban every product.

So it ends up being applied in an unprincipled and arbitrary manner.
In some cases, economic protectionism seems to be the deciding factor;
in others, officials appear to be bowing to irrational public fears.

ARBITRARY AND CAPRICIOUS

The precautionary principle has already unleashed a wave of absurd and
arbitrary risk decisions since the European Union adopted it in 1992.

We recently analyzed more than 60 decisions by EU courts in the
1995-2004 period, in which the precautionary principle was cited. (The
results are explained more fully in our 2004 book, Arbitrary and
Capricious: The Precautionary Principle in the European Courts.) We
found that despite using the precautionary principle to decide several
important cases, the EU courts failed to define or articulate the
specific requirements or meaning of this principle. They simply
invoked it as a wild card that justified whatever decision they wanted
to make.

In some cases the courts acted quite sensibly to overturn regulatory
decisions by individual nations where the precautionary principle
lacked any scientific justification. For example, Denmark relied on
the precautionary principle to ban cranberry-juice drinks because the
added vitamin C could potentially be harmful to some unusually
susceptible individuals. The EU Court of First Instance initially
upheld this ban, writing that "a plausible public-health risk is
enough, according to the precautionary principle." But the appellate
European Court of Justice overturned the ban in 2003, holding that,
notwithstanding the precautionary principle, an EU member nation that
seeks to ban a product must demonstrate a "real risk" that is
"sufficiently established on the basis of the latest scientific data."

Similarly, an EU court in 2001 overturned a decision by Norway to ban
corn flakes fortified with several essential vitamins -- a ban that
the Norwegian government had justified under the precautionary
principle because "the fortification in question might be a health
hazard when eaten in uncontrollable and unforeseen amounts." Yet
another court decision in 2004 overturned a regulation by France
banning caffeinated energy drinks because the caffeine could
potentially harm pregnant women. The courts concluded that these
regulations based on the precautionary principle were unjustified
departures from reasoned decision-making that lacked any credible
scientific support.

NO FAIR NOTICE

Certainly the EU courts have not always seen through weak
precautionary principle arguments, choosing instead to join regulatory
agencies in applying the principle in unreasonable ways.

For example, the Court of First Instance in 2002 used the
precautionary principle to uphold the EU ban on using virginiamycin --
an antibiotic widely sold by Pfizer -- in animal feed even though the
product had been used for 40 years without showing any signs of
danger. The court's opinion started reasonably, stating that even
under the precautionary principle, the European Union's proposed feed
ban must be based on "as thorough a scientific risk assessment as
possible" to ensure that regulations are "founded on objective and
sound scientific findings." But the court then found that the ban was
justified by a risk assessment made by a scientific advisory
committee, even though that committee had "firmly" concluded that
there would be no risk from the continued use of virginiamycin while
further studies on the safety of the antibiotic were completed.

The court held that under the precautionary principle, the European
Union was justified in departing from the expert scientific opinion
"on the ground that it was in the interests of human health
protection." The perplexing outcome of this case: While EU regulations
require a valid, scientific risk assessment, the European Union can
adopt a regulation directly contrary to the conclusions of that
assessment by invoking the precautionary principle.

In another case, the European Court of Justice in 2000 held a company
criminally liable for producing a hazardous waste that did not even
meet the European Union's own regulatory criteria for a hazardous
waste. Although the applicable EU rules explicitly stated that a
company could be held liable only for hazardous wastes that met the
regulatory criteria, the court decided that the precautionary
principle justified ignoring statutory construction, due process, and
fair-notice concerns. The court's decision upheld the opinion of its
advocate general, who argued that "determining in advance and in a
limitative manner the circumstances requiring the intervention of
public authorities to avert a specific risk to the environment" would
be contrary to the precautionary principle.

In still other cases, EU courts dismissed the precautionary principle
as an insignificant and irrelevant provision that added nothing to the
pre-existing statutory requirements. For example, in one 2001 decision
rejecting France's attempt to block imports of British beef based on
fears of mad cow disease, the European Court of Justice stated that
France's invocation of the precautionary principle to justify its
import ban "added nothing" to its argument.

In short, depending on the inclinations of individual judges, the
precautionary principle can vary anywhere from an absolutist, extreme
measure that mandates zero risk to an empty concept that has no
substantive effect on decisions.

OPEN TO IRRATIONALITY

Thus, the track record of the precautionary principle in Europe is not
good. Given its inherent flaws and ambiguity, the principle cannot be
sustained in the long run. As the EU courts' advocate general warned
in one opinion, "The precautionary principle has a future only to the
extent that, far from opening the door wide to irrationality, it
establishes itself as an aspect of the rational management of risks,
designed not to achieve zero risk, which everything suggests does not
exist."

Yet despite this troubling empirical record, there seems to be no
letup in the proliferation of the precautionary principle around the
world. Courts in Canada, India, Australia, and New Zealand have
recently endorsed this principle. Several international environmental
treaties, such as the Stockholm Convention on Persistent Organic
Pollutants, expressly incorporate the precautionary principle.

San Francisco recently became the first U.S. city to officially adopt
the precautionary principle, requiring by ordinance that "All
officers, boards, commissions, and departments of the City and County
shall implement the Precautionary Principle in conducting the City and
County's affairs." Several other U.S. cities are reportedly
considering following suit.

Decisions about regulating risks involve a complex interaction of
science, public policy, values, economics, incentives, precautions,
and uncertainty. Attempting to replace the admittedly difficult and
messy steps needed to reach the best possible risk decisions with a
simplistic slogan like the precautionary principle is inconsistent
with fundamental tenets of democracy. The inherent ambiguity and
arbitrariness of the principle give regulators unfettered discretion
to adopt unreasonable regulations, contrary to the greater principle
that we have a government of laws, not men.

The precautionary principle is an open invitation for nations to
impose protectionist restrictions on trade, for regulators to write
burdensome rules based on bias or emotion, and for companies to lobby
for unfair restrictions on their competitors. Moreover, because the
principle does not provide a meaningful foundation for making risk
decisions, the true basis for these decisions is kept hidden,
undermining the transparency and public accountability critical to
democratic government. In short, the rapidly proliferating
precautionary principle is bound to inflict a lot more damage around
the world before it finally and inevitably collapses upon itself.