Policy Review
June 15, 2001


By Henry I. Miller and Gregory Conko

Environmental and public health activists have clashed with scholars
and risk-analysis professionals for decades over the appropriate
regulation of various risks, including those from consumer products
and manufacturing processes. Underlying the controversies about
various specific issues — such as chlorinated water, pesticides, gene-
spliced foods, and hormones in beef — has been a fundamental, almost
philosophical question: How should regulators, acting as society’s
surrogate, approach risk in the absence of certainty about the
likelihood or magnitude of potential harm?

Proponents of a more risk-averse approach have advocated a
“precautionary principle” to reduce risks and make our lives safer.
There is no widely accepted definition of the principle, but in its
most common formulation, governments should implement regulatory
measures to prevent or restrict actions that raise even conjectural
threats of harm to human health or the environment, even though there
may be incomplete scientific evidence as to the potential significance
of these dangers. Use of the precautionary principle is sometimes
represented as “erring on the side of safety,” or “better safe than
sorry” — the idea being that the failure to regulate risky activities
sufficiently could result in severe harm to human health or the
environment, and that “overregulation” causes little or no harm.
Brandishing the precautionary principle, environmental groups have
prevailed upon governments in recent decades to assail the chemical
industry and, more recently, the food industry.

Potential risks should, of course, be taken into consideration before
proceeding with any new activity or product, whether it is the siting
of a power plant or the introduction of a new drug into the pharmacy.
But the precautionary principle focuses solely on the possibility that
technologies could pose unique, extreme, or unmanageable risks, even
after considerable testing has already been conducted. What is missing
from precautionary calculus is an acknowledgment that even when
technologies introduce new risks, most confer net benefits — that is,
their use reduces many other, often far more serious, hazards.
Examples include blood transfusions, MRI scans, and automobile air
bags, all of which offer immense benefits and only minimal risk.

Several subjective factors can cloud thinking about risks and
influence how nonexperts view them. Studies of risk perception have
shown that people tend to overestimate risks that are unfamiliar, hard
to understand, invisible, involuntary, and/or potentially catastrophic
— and vice versa. Thus, they overestimate invisible “threats” such as
electromagnetic radiation and trace amounts of pesticides in foods,
which inspire uncertainty and fear sometimes verging on superstition.
Conversely, they tend to underestimate risks the nature of which they
consider to be clear and comprehensible, such as using a chain saw or
riding a motorcycle.

These distorted perceptions complicate the regulation of risk, for if
democracy must eventually take public opinion into account, good
government must also discount heuristic errors or prejudices. Edmund
Burke emphasized government’s pivotal role in making such judgments:
“Your Representative owes you, not only his industry, but his
judgment; and he betrays, instead of serving you, if he sacrifices it
to your opinion.” Government leaders should lead; or putting it
another way, government officials should make decisions that are
rational and in the public interest even if they are unpopular at the
time. This is especially true if, as is the case for most federal and
state regulators, they are granted what amounts to lifetime job tenure
in order to shield them from political manipulation or retaliation.
Yet in too many cases, the precautionary principle has led regulators
to abandon the careful balancing of risks and benefits — that is, to
make decisions, in the name of precaution, that cost real lives due to
forgone benefits.

The danger of precaution

he danger in the precautionary principle is that it distracts
consumers and policymakers from known, significant threats to human
health and diverts limited public health resources from those genuine
and far greater risks. Consider, for example, the environmental
movement’s campaign to rid society of chlorinated compounds.

By the late 1980s, environmental activists were attempting to convince
water authorities around the world of the possibility that
carcinogenic byproducts from chlorination of drinking water posed a
potential cancer risk. Peruvian officials, caught in a budget crisis,
used this supposed threat to public health as a justification to stop
chlorinating much of the country’s drinking water. That decision
contributed to the acceleration and spread of Latin America’s 1991-96
cholera epidemic, which afflicted more than 1.3 million people and
killed at least 11,000.

Activists have since extended their antichlorine campaign to so-called
“endocrine disrupters,” or modulators, asserting that certain
primarily man-made chemicals mimic or interfere with human hormones
(especially estrogens) in the body and thereby cause a range of
abnormalities and diseases related to the endocrine system.

The American Council on Science and Health has explored the endocrine
disrupter hypothesis and found that while high doses of certain
environmental contaminants produce toxic effects in laboratory test
animals — in some cases involving the endocrine system — humans’
actual exposure to these suspected endocrine modulators is many orders
of magnitude lower. It is well documented that while a chemical
administered at high doses may cause cancer in certain laboratory
animals, it does not necessarily cause cancer in humans — both because
of different susceptibilities and because humans are subjected to far
lower exposures to synthetic environmental chemicals.

No consistent, convincing association has been demonstrated between
real-world exposures to synthetic chemicals in the environment and
increased cancer in hormonally sensitive human tissues. Moreover,
humans are routinely exposed through their diet to many estrogenic
substances (substances having an effect similar to that of the human
hormone estrogen) found in many plants. Dietary exposures to these
plant estrogens, or phytoestrogens, are far greater than exposures to
supposed synthetic endocrine modulators, and no adverse health effects
have been associated with the overwhelming majority of these dietary

Furthermore, there is currently a trend toward lower concentrations of
many contaminants in air, water, and soil — including several that are
suspected of being endocrine disrupters. Some of the key research
findings that stimulated the endocrine disrupter hypothesis originally
have been retracted or are not reproducible. The available human
epidemiological data do not show any consistent, convincing evidence
of negative health effects related to industrial chemicals that are
suspected of disrupting the endocrine system. In spite of that,
activists and many government regulators continue to invoke the need
for precautionary (over-) regulation of various products, and even
outright bans.

Antichlorine campaigners more recently have turned their attacks to
phthalates, liquid organic compounds added to certain plastics to make
them softer. These soft plastics are used for important medical
devices, particularly fluid containers, blood bags, tubing, and
gloves; children’s toys such as teething rings and rattles; and
household and industrial items such as wire coating and flooring.
Waving the banner of the precautionary principle, activists claim that
phthalates might have numerous adverse health effects — even in the
face of significant scientific evidence to the contrary. Governments
have taken these unsupported claims seriously, and several formal and
informal bans have been implemented around the world. As a result,
consumers have been denied product choices, and doctors and their
patients deprived of life-saving tools.

In addition to the loss of beneficial products, there are more
indirect and subtle perils of government overregulation established in
the name of the precautionary principle. Money spent on implementing
and complying with regulation (justified or not) exerts an “income
effect” that reflects the correlation between wealth and health, an
issue popularized by the late political scientist Aaron Wildavsky. It
is no coincidence, he argued, that richer societies have lower
mortality rates than poorer ones. To deprive communities of wealth,
therefore, is to enhance their risks.

Wildavsky’s argument is correct: Wealthier individuals are able to
purchase better health care, enjoy more nutritious diets, and lead
generally less stressful lives. Conversely, the deprivation of income
itself has adverse health effects — for example an increased incidence
of stress-related problems including ulcers, hypertension, heart
attacks, depression, and suicides.

It is difficult to quantify precisely the relationship between
mortality and the deprivation of income, but academic studies suggest,
as a conservative estimate, that every $7.25 million of regulatory
costs will induce one additional fatality through this “income
effect.” The excess costs in the tens of billions of dollars required
annually by precautionary regulation for various classes of consumer
products would, therefore, be expected to cause thousands of deaths
per year. These are the real costs of “erring on the side of safety.”
The expression “regulatory overkill” is not merely a figure of speech.

Rationalizing precaution

uring the past few years, skeptics have begun more actively to
question the theory and practice of the precautionary principle. In
response to those challenges, the European Commission (EC), a
prominent advocate of the precautionary principle, last year published
a formal communication to clarify and to promote the legitimacy of the
concept. The EC resolved that, under its auspices, precautionary
restrictions would be “proportional to the chosen level of
protection,” “non-discriminatory in their application,” and
“consistent with other similar measures.” The commission also avowed
that EC decision makers would carefully weigh “potential benefits and
costs.” EC Health Commissioner David Byrne, repeating these points
last year in an article on food and agriculture regulation in European
Affairs, asked rhetorically, “How could a Commissioner for Health and
Consumer Protection reject or ignore well-founded, independent
scientific advice in relation to food safety?”

Byrne should answer his own question: The ongoing dispute between his
European Commission and the United States and Canada over restrictions
on hormone-treated beef cattle is exactly such a case of rejecting or
ignoring well-founded research. The EC argued that the precautionary
principle permits restriction of imports of U.S. and Canadian beef
from cattle treated with certain growth hormones.

In their rulings, a WTO dispute resolution panel and its appellate
board both acknowledged that the general “look before you leap” sense
of the precautionary principle could be found within WTO agreements,
but that its presence did not relieve the European Commission of its
obligation to base policy on the outcome of a scientific risk
assessment. And the risk assessment clearly favored the U.S.-Canadian
position. A scientific committee assembled by the WTO dispute
resolution panel found that even the scientific studies cited by the
EC in its own defense did not indicate a safety risk when the hormones
in question were used in accordance with accepted animal husbandry
practices. Thus, the WTO ruled in favor of the United States and
Canada because the European Commission had failed to demonstrate a
real or imminent harm. Nevertheless, the EC continues to enforce
restrictions on hormone-treated beef, a blatantly unscientific and
protectionist policy that belies the commission’s insistence that the
precautionary principle will not be abused.

Precaution meets biotech

erhaps the most egregious application by the European Commission of
the precautionary principle is in its regulation of the products of
the new biotechnology, or gene-splicing. By the early 1990s, many of
the countries in Western Europe, as well as the EC itself, had erected
strict rules regarding the testing and commercialization of gene-
spliced crop plants. In 1999, the European Commission explicitly
invoked the precautionary principle in establishing a moratorium on
the approval of all new gene-spliced crop varieties, pending approval
of an even more strict EU-wide regulation.

Notwithstanding the ec’s promises that the precautionary principle
would not be abused, all of the stipulations enumerated by the
commission have been flagrantly ignored or tortured in its regulatory
approach to gene-spliced (or in their argot, “genetically modified” or
“GM”) foods. Rules for gene-spliced plants and microorganisms are
inconsistent, discriminatory, and bear no proportionality to risk. In
fact, there is arguably inverse proportionality to risk, in that the
more crudely crafted organisms of the old days of mutagenesis and gene
transfers are subject to less stringent regulation than those
organisms more precisely crafted by biotech. This amounts to a
violation of a cardinal principle of regulation: that the degree of
regulatory scrutiny should be commensurate with risk.

Dozens of scientific bodies — including the U.S. National Academy of
Sciences (NAS), the American Medical Association, the UK’s Royal
Society, and the World Health Organization — have analyzed the
oversight that is appropriate for gene-spliced organisms and arrived
at remarkably congruent conclusions: The newer molecular techniques
for genetic improvement are an extension, or refinement, of earlier,
far less precise ones; adding genes to plants or microorganisms does
not make them less safe either to the environment or to eat; the risks
associated with gene-spliced organisms are the same in kind as those
associated with conventionally modified organisms and unmodified ones;
and regulation should be based upon the risk-related characteristics
of individual products, regardless of the techniques used in their

An authoritative 1989 analysis of the modern gene-splicing techniques
published by the NAS’s research arm, the National Research Council,
concluded that “the same physical and biological laws govern the
response of organisms modified by modern molecular and cellular
methods and those produced by classical methods,” but it went on to
observe that gene-splicing is more precise, circumscribed, and
predictable than other techniques.

[Gene-splicing] methodology makes it possible to introduce pieces of
DNA, consisting of either single or multiple genes, that can be
defined in function and even in nucleotide sequence. With classical
techniques of gene transfer, a variable number of genes can be
transferred, the number depending on the mechanism of transfer; but
predicting the precise number or the traits that have been transferred
is difficult, and we cannot always predict the [characteristics] that
will result. With organisms modified by molecular methods, we are in a
better, if not perfect, position to predict the [characteristics].

In other words, gene-splicing technology is a refinement of older,
less precise techniques, and its use generates less uncertainty. But
for gene-spliced plants, both the fact and degree of regulation are
determined by the production methods — that is, if gene-splicing
techniques have been used, the plant is immediately subject to
extraordinary pre-market testing requirements for human health and
environmental safety, regardless of the level of risk posed.
Throughout most of the world, gene-spliced crop plants such as insect-
resistant corn and cotton are subject to a lengthy and hugely
expensive process of mandatory testing before they can be brought to
market, while plants with similar properties but developed with older,
less precise genetic techniques are exempt from such requirements.

Dozens of new plant varieties produced through hybridization and other
traditional methods of genetic improvement enter the marketplace each
year without any scientific review or special labeling. Many such
products are from “wide crosses,” hybridizations in which large
numbers of genes are moved from one species or one genus to another to
create a plant variety that does not and cannot exist in nature. For
example, Triticum agropyrotriticum is a relatively new man-made
“species” which resulted from combining genes from bread wheat and a
grass sometimes called quackgrass or couchgrass. Possessing all the
chromosomes of wheat and one extra whole genome from the quackgrass,
T. agropyrotriticum has been independently produced in the former
Soviet Union, Canada, the United States, France, Germany, and China.
It is grown for both animal feed and human consumption.

At least in theory, several kinds of problems could result from such a
genetic construction, one that introduces tens of thousands of foreign
genes into an established plant variety. These include the potential
for increased invasiveness of the plant in the field, and the
possibility that quackgrass-derived proteins could be toxic or
allergenic. But regulators have evinced no concern about these
possibilities. Instead, they have concentrated on the use of gene-
splicing techniques as such — the very techniques that scientists
agree have improved precision and predictability.

Another striking example of the disproportionate regulatory burden
borne only by gene-spliced plants involves a process called induced-
mutation breeding, which has been in common use since the 1950s. This
technique involves exposing crop plants to ionizing radiation or toxic
chemicals to induce random genetic mutations. These treatments most
often kill the plants (or seeds) or cause detrimental genetic changes,
but on rare occasions, the result is a desirable mutation — for
example, one producing a new trait in the plant that is agronomically
useful, such as altered height, more seeds, or larger fruit. In these
cases, breeders have no real knowledge of the exact nature of the
genetic mutation(s) that produced the useful trait, or of what other
mutations might have occurred in the plant. Yet the approximately
1,400 mutation-bred plant varieties from a range of different species
that have been marketed over the past half century have been subject
to no formal regulation before reaching the market — even though
several, including two varieties of squash and one of potato, have
contained dangerous levels of endogenous toxins and had to be banned

What does this regulatory inconsistency mean in practice? If a student
doing a school biology project takes a packet of “conventional” tomato
or pea seeds to be irradiated at the local hospital x-ray suite and
plants them in his backyard in order to investigate interesting
mutants, he need not seek approval from any local, national, or
international authority. However, if the seeds have been modified by
the addition of one or a few genes via gene-splicing techniques — and
even if the genetic change is merely to remove a gene — this would-be
Mendel faces a mountain of bureaucratic paperwork and expense (to say
nothing of the very real possibility of vandalism, since the site of
the experiment must be publicized and some opponents of biotech are
believers in “direct action”). The same would apply, of course, to
professional agricultural scientists in industry and academia. In the
United States, Department of Agriculture requirements for paperwork
and field trial design make field trials with gene-spliced organisms
10 to 20 times more expensive than the same experiments with virtually
identical organisms that have been modified with conventional genetic

Why are new genetic constructions crafted with these older techniques
exempt from regulation, from the dirt to the dinner plate? Why don’t
regulatory regimes require that new genetic variants made with older
techniques be evaluated for increased weediness or invasiveness, or
for new allergens that could show up in food? The answer is based on
millennia of experience with genetically improved crop plants from the
era before gene-splicing: Even the use of relatively crude and
unpredictable genetic techniques for the improvement of crops and
microorganisms poses minimal — but, as noted above, not zero — risk to
human health and the environment.

If the proponents of the precautionary principle were applying it
rationally and fairly, surely greater precaution would be appropriate
not to gene-splicing but to the cruder, less precise, less predictable
“conventional” forms of genetic modification. Furthermore, in spite of
the assurance of the European Commission and other advocates of the
precautionary principle, regulators of gene-spliced products seldom
take into consideration the potential risk-reducing benefits of the
technology. For example, some of the most successful of the gene-
spliced crops, especially cotton and corn, have been constructed by
splicing in a bacterial gene that produces a protein toxic to
predatory insects, but not to people or other mammals. Not only do
these gene-spliced corn varieties repel pests, but grain obtained from
them is less likely to contain Fusarium, a toxic fungus often carried
into the plants by the insects. That, in turn, significantly reduces
the levels of the fungal toxin fumonisin, which is known to cause
fatal diseases in horses and swine that eat infected corn, and
esophageal cancer in humans. When harvested, these gene-spliced
varieties of grain also end up with lower concentrations of insect
parts than conventional varieties. Thus, gene-spliced corn is not only
cheaper to produce but yields a higher quality product and is a
potential boon to public health. Moreover, by reducing the need for
spraying chemical pesticides on crops, it is environmentally friendly.

Other products, such as gene-spliced herbicide-resistant crops, have
permitted farmers to reduce their herbicide use and to adopt more
environment-friendly no-till farming practices. Crops now in
development with improved yields would allow more food to be grown on
less acreage, saving more land area for wildlife or other uses. And
recently developed plant varieties with enhanced levels of vitamins,
minerals, and dietary proteins could dramatically improve the health
of hundreds of millions of malnourished people in developing
countries. These are the kinds of tangible environmental and health
benefits that invariably are given little or no weight in
precautionary risk calculations.

In spite of incontrovertible benefits and greater predictability and
safety of gene-spliced plants and foods, regulatory agencies have
regulated them in a discriminatory, unnecessarily burdensome way. They
have imposed requirements that could not possibly be met for
conventionally bred crop plants. And, as the European Commission’s
moratorium on new product approvals demonstrates, even when that
extraordinary burden of proof is met via monumental amounts of testing
and evaluation, regulators frequently declare themselves unsatisfied.

Biased decision making

hile the european union is a prominent practitioner of the
precautionary principle on issues ranging from toxic substances and
the new biotechnology to climate change and gun control, U.S.
regulatory agencies also commonly practice excessively precautionary
regulation. The precise term of art “precautionary principle” is not
used in U.S. public policy, but the regulation of such products as
pharmaceuticals, food additives, gene-spliced plants and
microorganisms, synthetic pesticides, and other chemicals is without
question “precautionary” in nature. U.S. regulators actually appear to
be more precautionary than the Europeans towards several kinds of
risks, including the licensing of new medicines, lead in gasoline,
nuclear power, and others. They have also been highly precautionary
towards gene-splicing, although not to the extremes of their European
counterparts. The main difference between precautionary regulation in
the United States and the use of the precautionary principle in Europe
is largely a matter of degree — with reference to products,
technologies, and activities — and of semantics.

In both the United States and Europe, public health and environmental
regulations usually require a risk assessment to determine the extent
of potential hazards and of exposure to them, followed by judgments
about how to regulate. The precautionary principle can distort this
process by introducing a systematic bias into decision making.
Regulators face an asymmetrical incentive structure in which they are
compelled to address the potential harms from new products, but are
free to discount the hidden risk-reducing properties of unused or
underused ones. The result is a lopsided process that is inherently
biased against change and therefore against innovation.

To see why, one must understand that there are two basic kinds of
mistaken decisions that a regulator can make: First, a harmful product
can be approved for marketing — called a Type I error in the parlance
of risk analysis. Second, a useful product can be rejected or delayed,
can fail to achieve approval at all, or can be inappropriately
withdrawn from the market — a Type II error. In other words, a
regulator commits a Type I error by permitting something harmful to
happen and a Type II error by preventing something beneficial from
becoming available. Both situations have negative consequences for the
public, but the outcomes for the regulator are very different.

Examples of this Type I-Type II error dichotomy in both the U.S. and
Europe abound, but it is perhaps illustrated most clearly in the FDA’s
approval process for new drugs. A classic example is the FDA’s
approval in 1976 of the swine flu vaccine — generally perceived as a
Type I error because while the vaccine was effective at preventing
influenza, it had a major side effect that was unknown at the time of
approval: A small number of patients suffered temporary paralysis from
Guillain-Barré Syndrome. This kind of mistake is highly visible and
has immediate consequences: The media pounce and the public and
Congress are roused, and Congress takes up the matter. Both the
developers of the product and the regulators who allowed it to be
marketed are excoriated and punished in such modern-day pillories as
congressional hearings, television newsmagazines, and newspaper
editorials. Because a regulatory official’s career might be damaged
irreparably by his good-faith but mistaken approval of a high-profile
product, decisions are often made defensively — in other words, above
all to avoid Type I errors.

Former FDA Commissioner Alexander Schmidt aptly summarized the
regulator’s dilemma:

In all our FDA history, we are unable to find a single instance where
a Congressional committee investigated the failure of FDA to approve a
new drug. But, the times when hearings have been held to criticize our
approval of a new drug have been so frequent that we have not been
able to count them. The message to FDA staff could not be clearer.
Whenever a controversy over a new drug is resolved by approval of the

drug, the agency and the individuals involved likely will be
investigated. Whenever such a drug is disapproved, no inquiry will be
made. The Congressional pressure for negative action is, therefore,
intense. And it seems to be ever increasing.

Type II errors in the form of excessive governmental requirements and
unreasonable decisions can cause a new product to be “disapproved,” in
Schmidt’s phrase, or to have its approval delayed. Unnecessary or
capricious delays are anathema to innovators, and they lessen
competition and inflate the ultimate price of the product. Consider
the FDA’s precipitate response to the 1999 death of a patient in a
University of Pennsylvania gene therapy trial for a genetic disease.
The cause of the incident had not been identified and the product
class (a preparation of the needed gene, encased in an enfeebled
adenovirus that would then be administered to the patient) had been
used in a large number of patients, with no fatalities and serious
side effects in only a small percentage of patients. But given the
high profile of the incident, regulators acted disproportionately.
They not only stopped the trial in which the fatality occurred and all
the other gene-therapy studies at the same university, but also halted
similar studies at other universities, as well as experiments using
adenovirus being conducted by the drug company Schering-Plough — one
for the treatment of liver cancer, the other for colorectal cancer
that had metastasized to the liver. By these actions, and by publicly
excoriating and humiliating the researchers involved (and halting
experiments of theirs that did not even involve adenovirus), the FDA
cast a pall over the entire field of gene therapy, setting it back
perhaps as much as a decade.

Although they can dramatically compromise public health, Type II
errors caused by a regulator’s bad judgment, timidity, or anxiety
seldom gain public attention. It may be only the employees of the
company that makes the product and a few stock market analysts and
investors who are knowledgeable about unnecessary delays. And if the
regulator’s mistake precipitates a corporate decision to abandon the
product, cause and effect are seldom connected in the public mind.
Naturally, the companies themselves are loath to complain publicly
about a mistaken FDA judgment, because the agency has so much
discretionary control over their ability to test and market products.
As a consequence, there may be no direct evidence of, or publicity
about, the lost societal benefits, to say nothing of the culpability
of regulatory officials.

Exceptions exist, of course. A few activists, such as the AIDS
advocacy groups that closely monitor the FDA, scrutinize agency review
of certain products and aggressively publicize Type II errors. In
addition, congressional oversight should provide a check on
regulators’ performance, but as noted above by former FDA Commissioner
Schmidt, only rarely does oversight focus on their Type II errors.
Type I errors make for more dramatic hearings, after all, including
injured patients and their family members. And even when such mistakes
are exposed, regulators frequently defend Type II errors as erring on
the side of caution — in effect, invoking the precautionary principle
— as they did in the wake of the University of Pennsylvania gene
therapy case. Too often this euphemism is accepted uncritically by
legislators, the media, and the public, and our system of
pharmaceutical oversight becomes progressively less responsive to the
public interest.

The FDA is not unique in this regard, of course. All regulatory
agencies are subject to the same sorts of social and political
pressures that cause them to be castigated when dangerous products
accidentally make it to market (even if, as is often the case, those
products produce net benefits) but to escape blame when they keep
beneficial products out of the hands of consumers. Adding the
precautionary principle’s bias against new products into the public
policy mix further encourages regulators to commit Type II errors in
their frenzy to avoid Type I errors. This is hardly conducive to
enhancing overall public safety.

Extreme precaution

or some antitechnology activists who push the precautionary principle,
the deeper issue is not really safety at all. Many are more
antibusiness and antitechnology than they are pro-safety. And in their
mission to oppose business interests and disparage technologies they
don’t like or that they have decided we just don’t need, they are
willing to seize any opportunity that presents itself.

These activists consistently (and intentionally) confuse plausibility
with provability. Consider, for example, Our Stolen Future, the bible
of the proponents of the endocrine disrupter hypothesis discussed
above. The book’s premise — that estrogen-like synthetic chemicals
damage health in a number of ways — is not supported by scientific
data. Much of the research offered as evidence for its arguments has
been discredited. The authors equivocate wildly: “Those exposed
prenatally to endocrine-disrupting chemicals may have abnormal hormone
levels as adults, and they could also pass on persistent chemicals
they themselves have inherited — both factors that could influence the
development of their own children [emphasis added].” The authors also
assume, in the absence of any actual evidence, that exposures to small
amounts of many chemicals create a synergistic effect — that is, that
total exposure constitutes a kind of witches’ brew that is far more
toxic than the sum of the parts. For these anti-innovation ideologues,
the mere fact that such questions have been asked requires that
inventors or producers expend time and resources answering them.
Meanwhile, the critics move on to yet another frightening plausibility
and still more questions. No matter how outlandish the claim, the
burden of proof is put on the innovator.

Whether the issue is environmental chemicals, nuclear power, or gene-
spliced plants, many activists are motivated by their own parochial
vision of what constitutes a “good society” and how to achieve it. One
prominent biotechnology critic at the Union of Concerned Scientists
rationalizes her organization’s opposition to gene-splicing as
follows: “Industrialized countries have few genuine needs for
innovative food stuffs, regardless of the method by which they are
produced”; therefore, society should not squander resources on
developing them. She concludes that although “the malnourished
homeless” are, indeed, a problem, the solution lies “in resolving
income disparities, and educating ourselves to make better choices
from among the abundant foods that are available.”

Greenpeace, one of the principal advocates of the precautionary
principle, offered in its 1999 IRS filings the organization’s view of
the role in society of safer, more nutritious, higher-yielding,
environment-friendly, gene-spliced plants: There isn’t any. By its own
admission, Greenpeace’s goal is not the prudent, safe use of gene-
spliced foods or even their mandatory labeling, but rather these
products’ “complete elimination [from] the food supply and the
environment.” Many of the groups, such as Greenpeace, do not stop at
demanding illogical and stultifying regulation or outright bans on
product testing and commercialization; they advocate and carry out
vandalism of the very field trials intended to answer questions about
environmental safety.

Such tortured logic and arrogance illustrate that the metastasis of
the precautionary principle generally, as well as the
pseudocontroversies over the testing and use of gene-spliced organisms
in particular, stem from a social vision that is not just strongly
antitechnology, but one that poses serious challenges to academic,
commercial, and individual freedom.

The precautionary principle shifts decision making power away from
individuals and into the hands of government bureaucrats and
environmental activists. Indeed, that is one of its attractions for
many NGOs. Carolyn Raffensperger, executive director of the Science
and Environmental Health Network, a consortium of radical groups,
asserts that discretion to apply the precautionary principle “is in
the hands of the people.” According to her, this devolution of power
is illustrated by violent demonstrations against economic
globalization such as those in Seattle at the 1999 meeting of the
World Trade Organization. “This is [about] how they want to live their
lives,” Raffensperger said.

To be more precise, it is about how small numbers of vocal activists
want the rest of us to live our lives. In other words, the issue here
is freedom and its infringement by ideologues who disapprove, on
principle, of a certain technology, or product, or economic system.

The theme underlying the antitechnology activism of today is not new.
It resonates well with historian Richard Hofstadter’s classic analysis
half a century ago of religious and political movements in American
public policy, The Paranoid Style in American Politics. Hofstadter
summarized the religious and political activists’ paranoia this way:
“The central image is that of a vast and sinister conspiracy, a
gigantic and yet subtle machinery of influence set in motion to
undermine and destroy a way of life.” He goes on to note a
characteristic “leap in imagination that is always made at some
critical point in the recital of events.” Susanne Huttner, associate
vice provost for research of the University of California system, has
placed biotechnology critics squarely in Hofstadter’s sights. Viewed
from Hofstadter’s model of the paranoid style, she has observed that
the “conspiracy” here lies in large-scale agriculture performed with
twenty-first century technology, and the “leap in imagination” lies in
the assertion that biotechnology is at base bad for agriculture,
farmers, and developing nations.

But can these generalizations apply to all biotechnologies? What about
veterinary diagnostics and vaccines? Plants resistant to disease,
insects, anddrought? Grains with enhanced nutrient content? Fruits
that act as vaccines and can immunize inhabitants of developing
countries against lethal and hugely prevalent infectious diseases?

Precaution v. freedom

istory offers compelling reasons to be cautious about societal risks,
to be sure. These include the risk of incorrectly assuming the absence
of danger (false negatives), overlooking low probability but high
impact events in risk assessments, the danger of long latency periods
before problems become apparent, and the lack of remediation methods
in the event of an adverse event. Conversely, there are compelling
reasons to be wary of excessive precaution, including the risk of too
eagerly detecting a nonexistent danger (false positives), the
financial cost of testing for or remediating low-risk problems, the
opportunity costs of forgoing net-beneficial activities, and the
availability of a contingency regime in case of an adverse event. The
challenge for regulators is to balance these competing risk scenarios
in a way that reduces overall harm to public health. This kind of risk
balancing is often conspicuously absent from precautionary regulation.

It is also important that regulators take into consideration the
degree of restraint generally imposed by society on individuals’ and
companies’ freedom to perform legitimate activities (e.g., scientific
research). In Western democratic societies, we enjoy long traditions
of relatively unfettered scientific research and development, except
in the very few cases where bona fide safety issues are raised.
Traditionally, we shrink from permitting small, authoritarian
minorities to dictate our social agenda, including what kinds of
research are permissible and which technologies and products should be
available in the marketplace.

Application of the precautionary principle has already elicited
unscientific, discriminatory policies that inflate the costs of
research, inhibit the development of new products, divert and waste
resources, and restrict consumer choice. The excessive and wrong-
headed regulation of the new biotechnology is one particularly
egregious example. Further encroachment of precautionary regulation
into other areas of domestic and international health and safety
standards will create a kind of “open sesame” that government
officials could invoke whenever they wish arbitrarily to introduce new
barriers to trade, or simply to yield disingenuously to the demands of
antitechnology activists. Those of us who both value the freedom to
perform legitimate research and believe in the wisdom of market
processes must not permit extremists acting in the name of
“precaution” to dictate the terms of the debate.

Policy Review
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