By Jonathan H. Adler
GLOBAL WARMING & OTHER ECO-MYTHS
Edited by Ronald Bailey
Environmental policy increasingly incorporates the
“precautionary principle” which calls upon governments to impose regulatory
measures based upon the barest potential of environmental harm.
The precautionary principle holds that “When an activity raises
threats of harm to human health or environment, precautionary measures should be
taken even if some cause and effect relationships are not fully established
A corollary to the precautionary principle is that the proponent
of an activity or new technology should bear the burden of proof to demonstrate
that it is without risk.
Applied in even a mild formulation, the precautionary principle
will create “bottlenecks” in the development and distribution of new
Some proponents of the precautionary principle call for moratoria
on the development and use of biotechnology and the phase-out of chlorinated
The precautionary principle was adopted in the Masstricht Treaty
of the European Union, referenced in numerous international environmental
treaties, and incorporated into the operative provisions of the Cartagena
Protocol on Biosafety.
Adopting the precautionary principle can increase risks to
human health and environmental protection by focusing on the risks posed by the
introduction of new technologies while ignoring the risks that new technologies
can alleviate or prevent.
Advocates of the precautionary principle tend to assume that
economic growth and development are themselves a threat to public health and
environmental protection, yet the rise of industrial society has coincided with
a massive explosion of wealth and health that is unprecedented in the history of
To enhance public health and environmental protection, the
precautionary principle should not be adopted.
Rather, the risks of new chemicals or products must be weighed against
the risks that they ameliorate or prevent.
More and more, environmental policy incorporates the “precautionary principle” which calls upon governments to impose regulatory measures based upon the barest potential of environmental harm. If a chemical substance might be causing harm, it should be controlled or eliminated. If a new technological innovation could have unknown environmental effects, it should not be permitted. The precautionary principle may appeal to common-sense notions of safety, but its application will not produce a safer, cleaner world. Quite the opposite. The incorporation of the precautionary principle in environmental, health, and safety regulation is itself a threat to environmental protection and optimal safeguards for public health.
The precautionary principle appeals to the common sense idea that “it is better to be safe than sorry.” At its core, the precautionary principle embodies “the belief that society should seek to avoid environmental damage by careful forward planning, blocking the flow of potentially harmful activities.”[iii] Simple safety measures, such as wearing a seatbelt or motorcycle helmet, can greatly reduce the risk of substantial harm at relatively modest cost. In many instances preventing harm can be easier and less costly than repairing damage after the fact. While the precautionary principle appeals to conventional notions of “safety” and “taking care,” it calls for more drastic measures than the adoption of cost-effective safety measures. Rather, it calls for a presumption that government action is required to address every potential risk. The principle is premised on the idea that all technologies and chemical substances are dangerous until proven safe. Drastic changes in regulatory policy are therefore required. In the words of its proponents, “new principles for conducting human affairs are necessary” as it is time to “adopt a precautionary approach to all human endeavors.” [iv]
A conventional formulation of the precautionary principle is outlined in the “Wingspread Consensus Statement,” a document drafted by several dozen environmental activists in January 1998.[v] (See Box 1.) Under the Wingspread formulation: “When an activity raises threats of harm to human health or environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”[vi] As applied in the environmental context, this means that it is better to err on the side of regulating or controlling new technologies than to risk new or unforeseen problems; “decision makers should act in advance of scientific certainty to protect the environment (and with it, the well-being of future generations) from incurring harm.”[vii] In this sense, the precautionary principle establishes a default rule for regulating new innovations, irrespective of the relative risk that they actually pose to human health or the environment. At its extreme, the principle calls for the elimination of substances that are not proven safe: “the precautionary principle calls for the prohibition of the release of substances which might cause harm to the environment even if insufficient or inadequate proof exists regarding the causal link.”[viii]
On the one hand, this aspect of the precautionary principle does not call for much. Scientific certainty is rare, and few environmental regulations would exist if absolute scientific certainty were required before their imposition. Rather, policy makers traditionally consider the weight of the evidence for or against a given causal relationship, and the costs involved with implementing a particular policy. In some cases, such as the link between cigarettes and lung cancer, the causal connection is easy to identify. In other cases, such as a postulated connection between water chlorination and the incidence of bladder cancer, the connection is more suspect, and the costs of reducing the risk are substantial. Most environmental laws nonetheless authorize regulation of potentially dangerous substances or activities with less-than absolute proof or quantification of environmental risk.
On the other hand, by emphasizing the need to act in the face of scientific uncertainty, before there is clear evidence of scientific harm, the precautionary principle lowers the threshold for what is considered reliable evidence of a potential effect. “Better safe than sorry” can be used to call for regulatory measures when there is little, if any evidence of an actual health or environmental impact. After all, it is impossible to disprove the existence of risk. As noted in chapter [seven, "The Attack on Plant BIotechnology," by Gregory Conko and C.S. Prakash], there is no evidence that even a single individual has suffered a negative reaction from the consumption of genetically engineered food. Yet proponents of the precautionary principle call for moratoria on the development and marketing of such products because such risks are “possible” and have yet to be unproven.
A related, corollary to the principle is a shift in the burden of proof for new technologies and inventions. Government agencies would not be required to demonstrate that a technology poses a likely risk. Rather, “the proponent of an activity, rather than the public, should bear the burden of proof” of demonstrating that it is risk free.[ix] Greenpeace’s Jeremy Leggett explains: “the modus operandi we would like to see is: ‘Do not admit a substance unless you have proof that it will do no harm to the environment.’”[x] The World Charter for Nature incorporates this position, holding that “where potential adverse effects are not fully understood, the activities should not proceed.”
Applied in even a mild formulation, the reverse onus idea will dramatically retard the development of new technologies. As Principle advocate Joel Tickner acknowledges, the principle “establishes a type of ‘speed bump,’ which creates bottlenecks in the development process” to slow down the introduction of new technologies.[xi] Applied in a more rigorous fashion, however, and the reverse onus could stop the flow of new innovations altogether. “The truth of the matter is that whoever has the burden of proof loses,” explains Boston University bioethicist George Annas.[xii]
Application of the principle to existing technologies, such as various industrial chemicals, would require eliminating thousands of substances from economic use. Proving that a new technology or product will cause no harm requires proving a negative, something that science cannot do. “It is not possible to prove something is harmless, any more than it is possible to prove that there are no fairies at the bottom of one’s garden,” notes environmental analyst Julian Morris.[xiii] The scientific process can test the robustness of a given hypothesis –substance X will cause cancer in mice or substance Y disrupts amphibian reproduction – but it cannot prove that a given substance is risk-free. Substance X might not cause rodent tumors, but it could always cause something else. For this reason, scientists fear that the precautionary principle could “block the development of any technology if there is the slightest theoretical possibility of harm.”[xiv] Indeed, “taken literally, the directive would be: ‘Don’t do anything.’”[xv]
Another corollary to the precautionary principle that is equally problematic is that the consideration of a given technology or environmental decision must “involve an examination of the full range of alternatives, including no action.”[xvi] Taken literally, this corollary calls for paralysis by analysis. It is simply impossible to consider the “full range” of alternatives. Some advocates of the precautionary principle suggest that this corollary would merely require a consideration of likely or possible alternatives as a part of the decision-making process, much like federal agencies in the United States must consider alternatives to proposed actions when undergoing Environmental Impact Statements under the National Environmental Policy Act. Thus, before a company could introduce a new pesticide, a regulatory agency would need to consider alternative means of controlling the target pest and whether the pest needs to be controlled at all. Even in this more mild form, the additional burden placed upon new technologies could be substantial, while doing little to improve public health or environmental protection. If existing alternatives were adequate, it is unlikely that a new product would be purchased in the marketplace.
Most proponents of the precautionary principle seek to regulate or eliminate specific technologies or chemical by-products. Groups such as Friends of the Earth and Environmental Defense appeal to the precautionary principle in calling for greater limits, if not complete moratoria, on the development and marketing of genetically engineered crops. The “Safe Trade” campaign organized by Greenpeace seeks to incorporate precautionary regulation into global trade rules under the World Trade Organization. The advocacy group Health Care without Harm seeks to ban the use of phthalate plasticizers in medical supplies for fear they might have, as-yet-unproven, negative health impacts. The precautionary principle is also a driving force behind arguments for adoption of the Kyoto Protocol on climate change.
Perhaps the most ambitious manifestation of the precautionary principle in environmental policy is the effort to eliminate the use of chlorine compounds, from the manufacture of pesticides and solvents, to pharmaceuticals and water purification. The application of the precautionary principle to chlorine was initiated by Greenpeace, but is supported by more mainstream environmental organizations as well, such as the National Wildlife Federation.[xvii] Ellen Silbergeld, a toxicologist with Environmental Defense, has argued that chlorine compounds should be presumed dangerous until proven safe.[xviii] The U.S.-Canada International Joint Commission (IJC) which oversees environmental protection of the Great Lakes recommended that the U.S. and Canada “consult with industry and other interests to develop timetables to sunset the use of chlorine and chlorine-containing compounds as industrial feedstocks, and [examine] the means of reducing and eliminating other uses,”[xix] and the Clinton Administration proposed a national study to outline a chlorine phase-out in 1994.[xx]
Several chlorine compounds, including PCBs, dioxins, and chlorofluorocarbons (CFCs), have been linked to public health or environmental problems. CFCs, for example, are largely responsible for depletion of stratospheric ozone. On this basis, Greenpeace and others call for applying the precautionary principle to all chlorine-based compounds, sunsetting existing uses and prohibiting new uses unless they can be proven to be perfectly safe. “The only rational, protective policy would be to phase out all chlorinated chemicals as a class. All of them,” explains Peter Montague of the Environmental Research Foundation. [xxi] “What the world needs is a reduction in the total burden of chlorinated chemicals, not just a reduction in one or two or 10 specific compounds.”[xxii] All chlorine compounds should be banned because chlorine is contained in some compounds -- dioxin, polychlorinated biphenyls, chloroflourocarbons -- believed to have negative health or environmental effects at sufficient doses. “We decided you can't distinguish among different compounds of chlorine as to which is harmful and which is not,” explained one member of the IJC explaining the basis for a chlorine sunset.[xxiii] “Phasing out chlorine is the only way to virtually eliminate dioxin, especially in industrial processes and products,” counsel analysts with the Science and Environmental Health Network, sponsor of the Wingspread conference.[xxiv]
No distinction is made between more or less harmful uses of chlorine, or
what offsetting benefits some uses of chlorine provide.
“There are no uses of chlorine that we regard as safe,” declares Joe
Thornton, a former analyst at Greenpeace and author of Pandora’s Poison:
Chorine Health and a New Environmental Strategy.
According to Thornton:
We need to treat organochlorines as a class. There are 11,000 in commerce
plus thousands more that are produced as by-products. It would be truly
impractical to regulate them one-by-one. . . . It makes sense to treat
organochlorines as guilty until proven innocent.[xxvi]
By this logic, it would make sense to ban oxygen and carbon because they are contained in compounds that contribute to smog. To many scientists, this idea is absurd. “It isn’t taken seriously from a scientific point of view,” Dr. Mario Molina told Science magazine.[xxvii] Molina was co-author of the Nobel-prize-winning studies of stratospheric ozone that led to the phase-out of chloroflourocarbons. Dr. Steven Safe, a toxicologist at Texas A & M University, agrees: “The idea of banning chlorine is patently ridiculous and scientifically indefensible.”[xxviii]
The effort to phase-out chlorine illustrates the potentially extreme consequences of adopting the precautionary principle in public policy. It is estimated that chlorine is used in the production of over 80 percent of all pharmaceuticals.[xxix] It is also used to purify nearly all of the American water supply. “None of the alternative disinfection processes that have been proposed to date are equally effective or economical,” report experts at the Harvard Center for Risk Analysis.[xxx] Not purifying water can be disastrous. In 1991, failure to chlorinate drinking water supplies in Peru contributed to a massive outbreak of cholera that infected over 300,000 people, killing several thousand.[xxxi]
Chlorination may well present some risks. Some scientists believe that excess water chlorination could contribute to bladder and rectal cancer. The risk of untreated water, however, is clearly far greater.[xxxii] Worldwide, over five million deaths per year are attributable to unsafe drinking water or inadequate sanitation, according to the World Health Organization.[xxxiii] Diarrhea alone kills 2.2 million children per year – or one child every 15 seconds – a toll that could be reduced dramatically by greater use of water chlorination.[xxxiv] “Chlorination and disinfection of the water supplies are the public health success story of the century,” argues Carol Henry of the International Life Sciences Institute. “To start altering this is some way has very grave and immediate consequences.”[xxxv] It is anything but a “safe” precaution against environmental risks.
Activists who apply the precautionary principle to chlorinated compounds
nonetheless advocate a sunset on all chlorine use.
This is not a policy that will maximize the protection of public health
and environmental protections. Nor
is it scientifically justified. A
handful of chlorinated chemicals have been linked to environmental problems,
while thousands of others are used for myriad productive purposes.
Yet these concerns do not phase proponents, as it is an essential element
of the precautionary principle that scientific evidence is not required for
“precautionary” government action. According
to Thornton, “Waiting to take preventative action until cause-effect linkages
are proven between individual chemicals and large-scale health effects is no
Most proponents of the precautionary principle trace its origins to the German principle of “foresight” or “forecaution” – Vorsorgeprinzip. [xxxvii] In the 1970s, this principle became the basis for social democratic environmental policies in West Germany, and eventually provided the impetus for aggressive environmental measures to address acid precipitation and other environmental concerns.[xxxviii] Germany was not unique in this regard, however, as other nations adopted “precautionary” measures in the post-World War II period as well. In the United States, for example, the so-called “Delaney Clause” which prohibited food additives, at any level, that were linked to cancer in laboratory animals. Over time, this led to increasingly stringent regulation as scientists were able to detect ever smaller traces of pesticides or other chemicals in processed foods, until the clause was repealed in 1996.[xxxix]
Despite its analog in the United States, the precautionary principle has had the most influence on European environmental policy. In the early 1980s, West Germany led efforts to incorporate precautionary measures into the Convention on Protection of the North Sea. At the Second North Sea Conference, ministers endorsed a “precautionary approach . . . which may require action to control inputs of such substances even before a causal link has been established by absolutely clear scientific evidence.”[xl]
The Second North Sea Ministerial Declaration was but the first of several European agreements that would explicitly endorse precautionary policies to one degree or another. In 1990, the Bergen Ministerial Declaration on Sustainable Development completely endorsed the precautionary principle, stating:
In order to achieve sustainable development, policies must be based on the precautionary principle. Environmental measures must anticipate, prevent, and attack the causes of environmental degradation. Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation.[xli]
Soon thereafter, the precautionary principle became official European policy. Article 130R(2) of the Maastricht Treaty creating the European Community, declares environmental policy of EC member nations is to be based upon “the precautionary principle and on principles that preventative actions should be taken.”[xlii]
Since the signing of the Maastricht Treaty, the precautionary principle
has been incorporated in to various aspects of European policy.
Some nations have cited the principle as justification for prohibiting
the importation of genetically modified crops.
The European Council of Ministers adopted a formal resolution in April
1999 calling upon the European Commission “to be in the future to be
determined to be guided by the precautionary principle “ in its legislative
proposals. This led to the European
Commission’s Communication on the Precautionary Principle, which
declared that the EU would apply the precautionary principle “where
preliminary objective scientific evaluation indicates that there are reasonable
grounds for concern that the potentially dangerous effects on the environment,
human, animal, or plant health may be inconsistent with the high level of
protection chosen for the community.”[xliii]
The spread of the precautionary principle in Europe was followed in international environmental agreements. The Rio Declaration, agreed to at the 1992 United Nations Earth Summit, declares that “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation,” and that “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities.”[xliv] The preamble to the Convention on Biological Diversity similarly declares that “where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.”[xlv] Similar language is included in other environmental treaties and agreements as well, including the Vienna Convention for the Protection of the Ozone Layer and the United Nations Framework Convention on Climate Change (see Box 2).
While some U.S. policies could be characterized as precautionary in nature, the precautionary principle has not become an official part of U.S. environmental policy. Nonetheless, it has been endorsed by various levels of government. In 1996, the President’s Council on Sustainable Development (PCSD) declared that “even in the face of scientific uncertainty, society should take reasonable actions to avert risks where potential harm to human health or the environment is thought to be serious or irreparable.”[xlvi] Similarly, as noted above, in 1992 the International Joint Commission, a U.S.-Canada organization that oversees protection of the Great Lakes, endorsed the precautionary principle as the basis for future environmental policy and called for the sunset of industrial chlorine use.[xlvii]
At present, it is unclear the extent to which the administration of President George W. Bush will embrace the precautionary principle. Before her appointment as administrator of the Environmental Protection Agency Christine Todd Whitman declared that “policymakers need to take a precautionary approach to environmental protection.” Echoing the language of the Wingspread Statement, she explained that “uncertainty is inherent in managing natural resources, recognize it is usually easier to prevent environmental damage than to repair it later, and shift the burden of proof away from those advocating protection toward those proposing an action that may be harmful.”[xlviii] The administration also endorsed an international treaty calling for the reduction and eventual elimination of selected “persistent organic pollutants” (POPs), such as PCBs and furans, based upon precautionary concerns. On the other hand, the Bush administration thus far has rejected the Kyoto Protocol on climate change, despite arguments that it represents a “precautionary” approach to concerns about climate change.[xlix]
Speaking in January 2002, the Bush Administration’s top regulatory
policy official, John Graham, explained that “the US government supports
precautionary approaches to risk management but we do not recognize any
universal precautionary principle.” The
speech suggested that Graham may temper Administrator Whitman’s precautionary
impulses. While it is always
possible to identify instances in which precautionary regulation could have
averted serious harms, Graham noted that there are many instances in which
postulated risks never materialized. In
these cases, precautionary measures would have wasted scarce resources and done
nothing to enhance public health. “Precaution
is a necessary and useful concept but it is also subjective and susceptible to
abuse,” and therefore cannot be the focal point of regulatory policy.
Graham concluded that “it may be wise to apply a precautionary approach
to any attempt to recommend a universal precautionary principle.”
In January 2000, negotiators from over 150 nations agreed to a protocol to the United Nations Convention on Biological Diversity to regulate international transport and trade genetically engineered products. Like most contemporary environmental agreements, the so-called Cartagena Protocol on Biosafety (named for Cartagena, Columbia, where much of the negotiation took place) includes language endorsing the precautionary principle. The Biosafety Protocol, however, is the first global environmental agreement to incorporate the principle into its operative provisions.
The Biosafety Protocol creates an international framework for the regulation of bioengineered products “that may have adverse effects on the conservation and sustainable use of biodiversity, taking also into account risks to human health.”[l] Specifically, the Protocol creates mechanisms whereby national governments will be able to restrict, or even prohibit, the importation of genetically engineered crops. Like many environmental treaties, the preamble to the protocol “reaffirm[s] the precautionary approach” contained in the 1992 Rio Declaration.[li] The protocol goes further, however, by explicitly stating that “[l]ack of scientific certainty” about potential risks of biotech products “shall not prevent” a member nation from limiting, or even prohibiting, the importation of a given biotech product.[lii] A country may even take into account “socio-economic considerations arising from the impact of living modified organisms” in deciding to block importation of a crop or foodstuff. Thus, under the Protocol, speculative risks to human health, the environment, or even national “culture” – such as traditional, and inefficient, farming practices – could provide a basis for obstructing trade.
By incorporating the precautionary principle into its operative provisions, the Biosafety Protocol marks a significant departure from traditional international trade rules. Under Article XX the General Agreement on Tariffs and Trade, countries nations are authorized to enact measures “relating to the conservation of exhaustible natural resources” or “necessary to protect human, animal or plant life or health.”[liii] For a measure to pass muster under Article XX, it may not be a “disguised restriction on international trade” nor may it be “applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination.”[liv] National environmental measures must be scientifically based and no more trade restrictive than necessary to meet their goals.[lv] In practice, this meant that nations could regulate the importation of goods based on their actual characteristics, but not the manner in which they were produced. A nation could impose neutral food safety rules that apply to all relevant foods, domestic and imported alike, but could not prohibit importation of a food merely because it was produced using particular methods or technologies.
Nations have sought to erect trade barriers through the imposition of putative health or environmental measures. In 1989, for example, the European Union banned the importation of beef from cattle that were treated with bovine growth hormones. Injecting cattle with naturally occurring growth hormones increases cattle growth and milk production. Growth hormones are used for these purposes by many cattle producers in the United States. The E.U. defended the hormone ban as a “precautionary” step to protect European consumers from potential effects of eating beef from hormone-treated cattle. E.U. officials, however, were unable to point to scientific research supporting these concerns. There is no credible scientific evidence that the use of bovine growth hormones poses any threat to human health. For this reason, most observers saw the import restriction as a protectionist effort to exclude U.S. producers from the lucrative European beef and offal markets.[lvi] In 1997, a World Trade Organization (WTO) dispute resolution panel sided with the United States, ruling that the import ban was a protectionist measure and not a neutral environmental regulation. The E.U. appealed, but to no avail, as the WTO panel again sided with the U.S. Had the E.U. been able to rely on the precautionary principle, it might have prevailed.
The bovine growth hormone dispute is not an isolated instance.
E.U. nations have also imposed limitations on the importation of
genetically engineered crops, despite the lack of scientific evidence that such
crops pose any risk to consumers or the environment.
Under traditional GATT-WTO rules, it seems clear that such restrictions
would be struck down as protectionist measures.
Import restrictions lacking any scientific basis could not be defended as
neutral protective measures. Under
the biosafety protocol, however, such measures could potentially be upheld due
to the protocol’s explicit incorporation of the precautionary principle.
Under the protocol, the lack of scientific evidence should not be an
obstacle to the imposition of unscientific import restrictions.
In theory, the precautionary principle enhances protection of public health and environmental concerns by reducing the threats posed by new technologies and development. In practice, this is not the case. By focusing on one set of risks – those posed by the introduction of new technologies with somewhat uncertain effects – the precautionary principle turns a blind eye to the harms that occur, or are made worse, due to the lack of technological development. Reflexive efforts to regulate one risk can create other, often more dangerous risks. “The truly fatal flaw of the precautionary principle, ignored by almost all the commentators, is the unsupported presumption that an action aimed at public health protection cannot possibly have negative effects on public health,” observes professor Frank Cross of the University of Texas.[lvii]
The case of biotechnology provides an obvious example of how precautionary regulation could have negative consequences for public health and environmental protection. As detailed in chapter ___, genetic modification of crops can increase yields in many ways, ranging from enhancing plant resistance to frost, pests, soil toxicity or salinity, and droughts, to regulating flowering and reducing spoilage. A scientific panel convened by the World Bank and Consultative Group on International Agricultural Research (CGIAR) concluded that genetic engineering could increase agricultural yields by as much as 25 percent.[lviii] Biotechnology not only holds the potential to increase per-acre yields, it could also increase the nutritional value of the crops that are grown. Genetically modified crops may well make food both more abundant and more nutritious.
Precautionary regulation that limits the development, testing, sale, or trade in genetically engineered products will limit the benefits that such technologies can provide. This could mean less food, and lower nutrition intake, for many of the world’s poor. Because agricultural biotechnology also holds the promise of increasing per-acre crop yields, limiting the use of genetically engineered crops will result in greater pressure to clear tropical forests and other undeveloped land for agricultural use. Without the contribution of new generations of GMOs, it will be immensely difficult to meet the rising food demands of the world’s peoples and still preserve large areas of undeveloped habitat. Even if the use of genetically engineered crops allows for the further intensification of agricultural production, which has environmental impacts of its own, these impacts pose a lesser threat to biodiversity than the unabated loss of native habitat throughout the world; “the environmental costs of expanding the area tilled are enormously greater than those of increasing yield.”[lix] An overemphasis on the potential risks of using agricultural biotechnology ignores the equal, if not far greater, risks of doing without such advances. “For the world’s developing countries, one of the greatest risks of genetic engineering is not being able to use this technology at all.”[lx]
this is anything but an isolated example. There
are numerous instances in which the adoption of “precautionary” measures to
control a given substance or technology will have negative impacts on public
health or environmental protection.
Perhaps the most prominent example of the harm caused by excessive “precaution” in regulatory policy is “drug lag” – the delay in approval of potentially life-saving medicines and treatments. The Food and Drug Administration (FDA) must approve new pharmaceuticals and medical devices before they may be used or prescribed. The purpose of FDA approval is to ensure that only those drugs are approved that are “safe and effective.” In a precautionary fashion, the FDA seeks to prevent the release of an unsafe drug. Delaying the availability of potentially life-saving treatment, however, poses risks of its own. In the simplest terms, if a new drug or medical treatment will start saving lives once it is approved, then the longer it takes for the government to approve the drug, the more likely it is that people will die awaiting treatment.[lxi]
This is not merely a theoretical concern. Consider the example of Misoprostol, a drug that prevents gastric ulcers.[lxii] Misoprostol was developed in the early 1980s, and was first approved in some nations in 1985. The FDA, however, did not approve use of Misoprostol until 1988. Even though the drug was already available in several dozen foreign countries, the FDA subjected Misoprostol to a nine-and-one-half month review. At the time, between 10,000 and 20,000 people died from gastric ulcers per year. Therefore, had Misoprostol been approved more rapidly, it could have saved as many as 8,000 to 15,000 lives. In other words, FDA’s delay cost lives, just as surely as does the approval and use of unsafe treatments. Thus, precautionary regulation by the FDA does not always enhance protection of public health.
Pesticides are a common target of precautionary principle advocates, but as with drug lag and biotechnology, it is not clear that more government regulation of chemical pesticides always makes people safer. In some cases, restrictions on the use of a pesticide can expose people to other risks, such as disease, or result in the use of more harmful substitutes. Ethylene dibromide (EDB), for example, was a powerful fungicide used to prevent the growth of molds on grain and other foods. Molds produce some of the most potent carcinogens found in nature, such as aflatoxin.[lxiii] Yet EDB was also deemed a potential carcinogen, and was banned by the U.S. Environmental Protection Agency (EPA). The ban was a precautionary measure, yet the EPA did not consider whether the risk of EDB was greater or lesser than that posed by aflatoxin. Moreover, EDB was replaced with fungicides that had to be applied in greater quantities, increasing the risk for exposed workers.[lxiv] Thus, the EDB ban may have, on net, increased risks to human health.
Among the chemicals targeted for elimination by advocates of the precautionary principle is DDT. Once widely used for mosquito control, DDT was banned in most developed nations due to concerns that its widespread use interfered with the reproduction of several bird species, including the bald eagle. In the years after World War II, DDT became the ultimate weapon in the battle against malaria. In Ceylon (now Sri Lanka), DDT spraying reduced the number of malaria cases from approximately three million in 1946 to approximately 7,300 in only a decade. By 1964, there were only 29 recorded malaria cases on the island nation.[lxv] In India, malaria cases dropped from an estimated 75 million in 1951 to approximately 50,000 by 1961.[lxvi] In industrialized nations, DDT helped eliminate malaria completely.
Evidence that DDT contributed to egg-shell thinning in some bird species, and fears that it could harm people as well, led to a ban on DDT in the United States in 1972. Other developed countries followed soon thereafter, and many developing countries restricted its use.[lxvii] At the time, there was concern – though little evidence – that DDT might pose a risk to public health. Rachel Carson’s Silent Spring and media alarmism contributed to fears that DDT use was poisoning America’s children. Foreshadowing later precautionary appeals for chemical phase-outs, then-EPA administrator William Ruckleshaus argued that DDT was “a warning that man may be exposing himself to a substance that may ultimately have a serious effect on his health.”[lxviii] Solid evidence of DDT’s health risks never materialized, however. A few animal studies suggest some risk, but epidemiological and other research has been inconclusive, producing no more than “weak evidence of harm to human health.”[lxix] Indeed, Harvard University’s Amir Attaran notes that “The scientific literature does not contain even one peer-reviewed, independently replicated study linking DDT exposures to any adverse health outcome” in humans.[lxx]
concerns about potential human health effects of DDT led to the pesticide’s
inclusion on a proposed list of “persistent organic pollutants” to be
completely phased out under an international agreement sponsored by the United
Nations Environment Program. During
the negotiations, however, the complete elimination of DDT was reconsidered.
Although DDT is virtually synonymous with industrial pollution in western
nations, it is known as a life-saving compound in much of the developing world.
DDT is still used in nearly two dozen countries for malaria control, and
for good reason.
DDT remains one of the few affordable, effective tools against the mosquitoes that transmit malaria, a plague that sickens at least 300 million and kills over one million, mainly children, in economically underdeveloped areas of the tropics each year. Such a toll is scarcely comprehensible. To visualize it, imagine filling seven Boeing 747s with children, and then crashing them, every day.[lxxi]
The phaseout of DDT before
the development of a suitable, cost-effective alternative would condemn millions
of people in the developing world to malaria infection and potential death.
Application of the precautionary principle to DDT, and eliminating it on
the basis of speculative concerns that it might harm human health, would
leave much of the world far less safe than it is today.
The use of DDT may yet be shown to cause health problems in humans; in
many developing countries, doing without DDT will definitely cause health
problems for millions. As two
malaria researchers observe, “DDT has saved countless millions of lives, while
Greenpeace struggles to find some evidence that it harms mankind.”[lxxii]
Advocates of the precautionary principle tend to assume that economic growth and development are themselves a threat to public health and environmental protection. The Wingspread Statement, for example, speaks of the “substantial unintended consequences” brought about by the industrial society.[lxxiii] An underlying premise of the precautionary principle is that modern industrial society is unsustainable and threatens the survival of humanity, if not much of the planet as well. This assumption is highly questionable, as the other chapters in this volume illustrate. Economic growth and technological progress have been a tremendous boon to both human health and environmental protection. Efforts to limit such progress are likely to be counterproductive. Regulatory measures that stifle innovation and suppress economic growth will deprive individuals with the resources necessary to improve their quality of life, and deny societies the ability to make investments that protect people and their environs.
The rise of industrial society has coincided with a massive explosion of wealth and health that is unprecedented in the history of human civilization. For centuries average life expectancy hovered in the twenties and thirties. U.S. life expectancy in 1900 was only 47. Today, in developed nations life expectancy is nearly 80.[lxxiv] Infant and maternal mortality plummeted over this same period, as have the incidence and mortality of typhoid, diptheria, tuberculosis, and other lethal diseases. [lxxv] These positive trends are largely the result of increased wealth, and the benefits such wealth brings. Higher economic growth and aggregate wealth strongly correlate with reduced mortality and morbidity.[lxxvi] This should be no surprise as the accumulation of wealth is necessary to fund medical research, support markets for advanced life-saving technologies, and build infrastructure necessary for better food distribution, and so on. In a phrase, poorer is sicker, and wealthier is healthier.[lxxvii]
Cancer rates are often blamed on environmental exposures to chemicals and other synthetic substances. Were this so, one would expect cancer rates to increase with the proliferation of synthetic chemicals in our food supply and environs. This has not been the case. The most recent report of the National Cancer Institute, overall incidence and death rates for cancer are also declining.[lxxviii] Even lung cancer incidence, largely the result of smoking, has begun to decline.[lxxix] Simply put, “[t]he common believe that there is an epidemic of death from cancer in developed countries is a myth, except for the effects of tobacco. . . . For most non-smokers, the health benefits of modern society outweigh the new hazards.”[lxxx] In short, “the Western world is a remarkably healthy place to live.”[lxxxi]
Economic progress is no less essential for environmental protection than for protection of public health. Environmental protection is a good and, like all goods, it must be purchased. Wealth is required to finance environmental improvements, from the purification of drinking water to invention and installation of low-emission technologies. Not only are wealthier communities healthier than poorer communities, on average, they tend to be more concerned about protecting environmental values as well. Wealthier societies have both the means and the desire to address a wider array of environmental concerns.[lxxxii]
Pollution, while still a serious environmental problem in much of the world, is not the mortal threat to human survival it once was. At the dawn of the 20th century, soot and smoke permeated cities, sometimes to lethal effect. In 1948, a four-day weather inversion in Donora, Pennsylvania, blanketed the town with pollution from local factories, killing eighteen people.[lxxxiii] Over the past several decades, pollution levels in wealthy, industrialized societies have declined, particularly in the case of those emissions for which the health impacts are most severe.[lxxxiv] “Countries undergo an environmental transition as they become wealthier and reach a point at which they start getting cleaner.”[lxxxv] This occurs first with particularly acute environmental concerns, such as access to safe drinking water and sanitation services. As affluence increases, so does the attention paid to conventional pollution concerns, such as fecal coliform bacteria and urban air quality.[lxxxvi]
There is no doubt that chemicals pose risks.
Indeed, some of the chemicals and other technologies targeted by
advocates of the precautionary principle can cause problems if misused.
Yet it is notable that the proliferation of these technologies has
coincided with the greatest explosion of prosperity and longevity in human
history. If modern society were as
risky as precautionary principle advocates suggest, this should not be the case.
The stated aim of the precautionary principle is to enhance protection of public health and environmental concerns. In practice, however, the precautionary principle is only applied to the risks of technological change and industrial society, with little appreciation for the risks that wealth and technology prevent. New technologies can be risky things. Some industrial chemicals may cause health problems even if used carefully. But this does not justify the adoption of a blanket precautionary rule suppressing chemical use and technological development.
If the true aim is a safer world, and not merely the retardation of technological progress, the risks of new chemicals or products must be weighed against the risks that they ameliorate or prevent. The risks of change must be weighed against the risk of stagnation. In every case, “[t]he empirical question is whether the health [and environmental] gains from the regulation of the substances involved are greater or lesser than the health [and environmental] costs of the regulation.”[lxxxvii] Genetically modified corn may pose hypothetical risks to butterflies in the wild, but the absence of genetically modified corn will perpetuate substantial risks to species habitat in the wild. The use of chlorine may create some compounds with carcinogenic potential, but the phase-out of chlorine would eliminate a tremendously valuable feedstock and greatly reduce the safety of the food supply.
precautionary principle rests upon an illusion that actions have no consequences
beyond their intended ends.”[lxxxviii]
In reality, even the most well-intentioned precautionary measures can
have terrible results. The precautionary principle’s threat to technological
progress is itself a threat to public health and environmental protection.
The world would be safer without it.
[i] Precautionary European regulation of biotechnology is summarized in Rod Hunter, “European Regulation of Genetically Modified Organisms,” in Fearing Food: Risk, Health, & Environment, Julian Morris & Roger Bate eds. (Oxford: Butterworth & Heinemann 1999), pp. 213-15; and Terrence P. Stewart & David S. Johanson, “Policy In Flux: The European Union’s Laws on Agricultural Biotechnology and Their Effects on International Trade,” Drake Journal of Agricultural Law, vol. 4 (1999), pp. 260-68.
[ii] See, generally, Bill Durodie, “Plastic Panics: European Risk Regulation in the Aftermath of BSE,” in Rethinking Risk and the Precautionary Principle, Julian Morris ed. (Oxford, UK: Butterworth Heinemann, 2000), pp. 140-166.
[iii] Joel Tickner, Carolyn Raffensperger, and Nancy Myers, The Precautionary Principle in Action: A Handbook (Science and Environmental Health Network, 1999), p. 3.
[iv] The Wingspread Statement on the Precautionary Principle, reprinted in Appendix A, Protecting Public Health & The Environment, Carolyn Raffensperger and Joel Tickner, eds. (Washington, DC: Island Press, 1999), pp. 353-55.
[v] Signatories of the statement included representatives of Greenpeace, Physicians for Social Responsibility, the W. Alton Jones Foundation, the Silicon Valley Toxics Coalition, and the Indigenous Environmental Network, among others.
[vi] The Wingspread Statement is reprinted in Appendix A, Protecting Public Health & The Environment, pp. 353-55.
[vii] Andrew Jordan and Timothy O’Riordan, “The Precautionary Principle in Contemporary Environmental Policy and Politics,” in Protecting Public Health and the Environment, p. 23.
[viii] P. Horsman of Greenpeace quoted in Jordan and O’Riordan, p. 25.
[ix] Appendix A, p. 354
[x] Quoted in Julian Morris, “Defining the Precautionary Principle,” in Rethinking Risk and the Precautionary Principle, Julian Morris ed. (Oxford, UK: Butterworth Heinemann, 2000), p. 4.
[xi] Joel A. Tickner, “A Map Toward Precautionary Decision Making,” in Protecting Public Health.
[xii] Quoted in Ronald Bailey, “Precautionary Tale,” Reason, April 1999, p. ___.
[xiii] Morris, p. 10.
[xiv] Soren Holm & John Harris, “Precautionary Principle Stifles Discovery,” Nature, vol. 400 (1999), p. 398.
[xv] Christopher D. Stone, “Is There a Precautionary Principle?” Environmental Law Reporter, vol. 31, (July 2001), p. 10790.
[xvi] The Wingspread Statement, quoted in Appendix A, p. 354.
[xvii] For a general overview of the anti-chlorine campaign, see Jonathan H. Adler, Environmentalism at the Crossroads: Green Activism in America (Washington, D.C.: Capital Research Center, 1995), pp. 40-42.
[xviii] Ivan Amato, “The Crusade Against Chlorine,” Science, July 9, 1993, p. 152.
[xix] Ivan Amato, “The Crusade to Ban Chlorine,” Garbage, Summer 1994, p. 36.
[xx] “Chemical Industry ‘Outraged’ By Chlorine Proposal; Proposed Regulations Would Seek to Reduce Use of Chlorine Compounds,” Chemical Marketing Reporter, February 7, 1994, p. 3; and, Russell Clemings, “Environmentalists Back Chlorine Limits,” Fresno Bee, February 21, 1994, A4.
[xxi] Peter Montague, “Modern Environmental Protection – Part 2,” Rachel’s Environment & Health News, no. 705, August 3, 2000.
[xxiii] Quoted in Michael Fumento, “The War on Chlorine,” Reason, June 1994.
[xxiv] Tickner, Raffensberger, and Myers, p. 17.
[xxv] Ivan Amato, “The Crusade Against Chlorine,” Science, July 9, 1993, p. 153.
[xxvi] Bette Hileman, “Debate Over Phaseout of Chlorine, Chlorinated Organics Continues,” Chemical & Engineering News, December 6, 1993, p.32.
[xxvii] Amato, “The Crusade Against Chlorine,” p. 154.
[xxviii] Ivan Amato, “The Crusade to Ban Chlorine,” Garbage, Summer 1994, p. 33.
[xxix] Bette Hileman, Concerns Broaden Over Chlorine and Chlorinated Hydrocarbons,” Chemical & Engineering News, April 19, 1993, p. 11.
[xxx] John D. Graham and George M. Gray, “Optimal Use of ‘Toxic Chemicals,’” Risk in Perspective, May 1993.
[xxxi] Christopher Anderson, “Cholera Epidemic Traced to Risk Miscalculation,” Nature, November 28, 1991, p. 255.
[xxxii] For an overview of the risk trade-offs involved with water chlorination, see Susan W. Putnam and Jonathan Baert Weiner, “Seeking Safe Drinking Water,” in Risk versus Risk: Tradeoffs in Protecting Health and the Environment, John D. Graham and Jonathan Baert Weiner eds. (Cambridge: Harvard University Press, 1995), pp. 124-148.
[xxxiii] World Health Organization, “Water and Sanitation,” Fact Sheet No. 112, November 1996, available at http://www.who.int/inf-fs/en/fact112.html.
[xxxiv] World Health Organization, Global Water Supply and Sanitation Assessment 2000 Report, Box 1.2, available at http://www.who.int/water_sanitation_health/Globalassessment/Global1.htm.
[xxxv] Quoted in Anderson.
[xxxvi] Joe Thornton, “The Case for A Chlorine Phase-Out,” presentation at the American Public Health Association Annual Meeting, November 11, 1992.
[xxxvii] Carolyn Raffensberger & Joel Tickner “Introduction: To Foresee and Forestall,” in Protecting Public Health and the Environment: Implementing the Precautionary Principle (Washington, D.C.: Island Press, 1999), p. 4.
[xxxviii] Ibid; Andrew Jordan and Timothy O’Riordan, “The Precautionary Principle in Contemporary Environmental Policy and Politics,” in Protecting Public Health and the Environment, p. 19.
[xxxix] For an overview of the Delaney Clause, see Michael Fumento, Science Under Siege: Balancing Technology and the Environment (New York: William Morrow & Co., 1993), pp. 54-57.
[xl] Quoted in Raffensberger & Tickner, “Introduction,” pp. 4-5.
[xli] Quoted in Appendix B in Protecting Public Health and the Environment, p357-58. The Bergen Declaration was agreed to at a meeting of the United Nations Economic Commission for Europe.
[xlii] Ibid., p. 359.
[xliii] European Commission, Communication from the Commission on the Precautionary Principle (Brussels, Commission of the European Communities, 2000).
[xliv] Rio Declaration on Environment and Development, principle 15, U.N. Doc. A/CONF.151/5/Rev.1 (1992).
[xlv] Ibid., preamble.
[xlvi] Quoted in Raffensberger & Tickner, “Introduction,” p. 6.
[xlvii] See International Joint Commission, Sixth Biennial Report on Great Lakes Water Quality (Washington, D.C.: International Joint Commission, April 1992).
[xlviii] Quoted in David Appell, “The New Uncertainty Principle,” Scientific American, January 2001.
[xlix] For an assessment of the threat posed by climate change, see the Christy chapter in this volume. For a discussion of precautionary measures and global climate change, see Jonathan Adler, et al., Greenhouse Policy Without Regrets (Washington, D.C.: Competitive Enterprise Institute, July 2000).
[l] Cartagena Protocol on Biosafety, article 4.
[li] Ibid, preamble.
[lii] Ibid, articles 10 & 11.
[liii] General Agreement on Tariffs and Trade, Art. XX (h), (b).
[lv] See, for example, James M. Sheehan, The Greening of Trade Policy (Washington, D.C.: Competitive Enterprise Institute, November 1994), p. 29 (discussing interpretation of GATT Article XX by dispute resolution panels).
[lvi] Daniel C. Esty, Greening the GATT: Trade, Environment, and the Future (Washington, D.C.: Institute for International Economics, 1994), p. 103.
[lvii] Frank B. Cross, “Paradoxical Perils of the Precautionary Principle,” Washington and Lee Law Review, vol. 53, No. 3 (1996), p. 860.
[lviii] See World Back Press Release, Bioengineering of Crops Could Help Feed the World; Crop Increases of 10-25 Percent Possible (Oct. 9, 1997) available at <http://www.worldbank.org/html/cgiar/press/biopress.html>.
[lix]. John H. Barton, “Biotechnology, The Environment, and International Agricultural Trade,” Georgetown International Environmental Law Review, vol. 9 (1996), pp. 95, 99.
[lx]. Laura Tangley, “Engineering the Harvest,” U.S. News & World Report, March 13, 2000, p. 46 (quoting Calestous Juma, a Kenyan advisor to the Harvard University Center for International Development and former executive secretary of the CBD).
Kazman, “Deadly Overcaution:
FDA’s Drug Approval Process,” Journal of Regulation and Social
Costs, September 1990, p. 35.
[lxii]. This discussion is based on the Kazman article; ibid., pp. 47-48.
[lxiii] George M. Gray and John D. Graham, “Regulating Pesticides,” in Risk versus Risk: Tradeoffs in Protecting Health and the Environment, John D. Graham and Jonathan Baert Weiner eds. (Cambridge: Harvard University Press, 1995), pp. 186-87.
[lxiv] Cross, “Paradoxical Perils,” pp. 875-76.
[lxv] Richard Tren and Roger Bate, Malaria and the DDT Story (London: Institute of Economic Affairs, 2001), pp. 36-37.
[lxvi] Ibid., p. 37.
[lxvii] Some argue that the development of resistance to DDT by mosquitoes led to a reduction in DDT use in developing nations. DDT, however, remained effective at mosquito control even after some resistance was developed. See ibid, pp. 46-47.
[lxviii] Quoted in ibid., p. 46.
[lxix] Amir Attaran, et al., “Balancing Risks on the Backs of the Poor,” Nature Medicine, Vol. 6, no. 7 (July 2000), pp. 729-31.
[lxx] Quoted in Ronald Bailey, “Green’s vs. the World’s Poor,” Reason Online, November 29, 2000, available at http://www.reason.com/hod/rb112900.html.
[lxxi] Attaran., “Balancing Risks,” p. 729.
[lxxii] Tren and Bate, p. 60.
[lxxiii] Appendix A, Protecting Public Health & The Environment, pp. 353-55
[lxxiv] CITE Eberstadt chapter?
[lxxv] CITE Eberstadt chapter?
[lxxvi] See, for example, Susan L. Ettner, “New Evidence on the Relationship Between Income and Health,” 15 Journal of Health Economics, vol 15 (1996), p. 67; John D. Graham, et al., “Poorer is Riskier,” Risk Analysis, vol. 12, no. 3 (1992), p. 333-37; Ralph L. Keeney, “Mortality Risks Induced by Economic Expenditures,” Risk Analysis, vol. 10, no. 1 (1990), pp. 147-59.
[lxxvii] This phrasing is attributed to the late Aaron Wildavsky.
[lxxviii] Holly L. Howe, et al., “Annual Report to the Nation on the Status of Cancer (1973 Through 1998), Featuring Cancers With Recent Increasing Trends, Journal of the National Cancer Institute, Vol. 93, No. 11, June 6, 2001.
[lxxx] Richard Peto, et al., Mortality from Smoking in Developed Countries, 1950-2000, (Oxford: Oxford University Press, 1994).
[lxxxii] See Seth W. Norton, “Property Rights, the Environment and Economic Well-Being”, in Who Owns the Environment? Peter J. Hill & Roger E. Meiners eds. (Lanham, MD: Rowman & Littlefield, 1998), pp. 37, 45.
[lxxxiii] Cited in Indur Goklany, “Richer Is Cleaner,” in The True State of the Planet, R. Bailey, ed. (New York: The Free Press, 1995), p. 347.
[lxxxiv] See, generally, id. See also, Indur Goklany, Clearing the Air: The Real Story of the War On Air Pollution (Washington, D.C.: Cato Institute, 1999).
[lxxxv] Goklany, “Richer Is Cleaner,” pp. 339, 341.
[lxxxvi] Goklany observes that while the “environmental transition” for drinking water and sanitation occurs “almost immediately as the level of affluence increases above subsistence,” the transition appears to occur at approximately $1,375 per capita for fecal coliform and $3,280 and $3670 per capita for urban particulate matter and sulfur dioxide concentrations respectively. Id. at 342. For a fuller treatment of the correlation between affluence and air quality, see Goklan, Clearing the Air.
[lxxxvii] Aaron Wildavsky, But Is It True? (1995), p. 428.
[lxxxviii] Cross, “Paradoxical Perils,” p. 924.