The precautionary principle in environmental science. (Commentaries).Environmental scientists play a key role in society's responses to environmental problems, and many of the studies they perform are intended ultimately to affect policy. The precautionary principle The precautionary principle is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate , proposed as a new guideline in environmental decision making, has four central components: taking preventive action A preventive action is a change implemented to address a weakness in a management system that is not yet responsible for causing nonconforming product or service. Candidates for preventive action generally result from suggestions from customers or participants in the process in the face of uncertainty; shifting the burden of proof The process of transferring the obligation to affirmatively prove a fact in controversy or an issue brought during a lawsuit from one party in a legal controversy to the other party. to the proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision making. In this paper we examine the implications of the precautionary principle for environmental scientists, whose work often involves studying highly complex, poorly understood systems, while at the same time facing conflicting pressures from those who seek to balance economic growth and environmental protection. In this complicated and contested terrain, it is useful to examine the methodologies of science and to consider ways that, without compromising integrity and objectivity, research can be more or less helpful to those who would act with precaution. We argue that a shift to more precautionary policies creates opportunities and challenges for scientists to think differently about the ways they conduct studies and communicate results. There is a complicated feedback relation between the discoveries of science and the setting of policy. While maintaining their objectivity and focus on understanding the world, environmental scientists should be aware of the policy uses of their work and of their social responsibility to do science that protects human health and the environment. The precautionary principle highlights this tight, challenging linkage between science and policy. Key words: environmental science, foresight, planning, precaution, risk assessment, science policy. Environ Health Perspect 109:871-876 (2001). [Online 15 August 2001] http://ehpnet1.niehs.nih.gov/docs/2001/109p871-876kriebel/abstract.html ********** There are few pressing social issues that depend as heavily on scientific information as do environmental problems. Most scientists and policy makers agree on the importance of science in environmental policy debates, even when they can agree on almost nothing else about the health of the ecosphere e·co·sphere n. The regions of the universe, especially on the earth, that are capable of supporting life; the biosphere. ecosphere . Thus, environmental scientists play a key role in society's responses to environmental problems, and many of the studies performed by environmental scientists are intended ultimately to affect policy. The precautionary principle has been proposed as a new guideline in making environmental policy (1,2). In this paper we examine the implications of the precautionary principle for environmental scientists. Specific objectives are to define the precautionary principle and illustrate it through three brief examples; identify aspects of conventional science that may inhibit precautionary policies; identify new directions for scientific research that would better inform precautionary policies; and promote dialogue among environmental scientists about the usefulness and potential applications of the precautionary principle. Definition of the Precautionary Principle A 1998 consensus statement characterized the precautionary principle this way: "when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically" (3). The statement went on to list four central components of the principle: taking preventive action in the face of uncertainty; shifting the burden of proof to the proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision making. The term "precautionary principle" came into English as a translation of the German word Vorsorgeprinzip. An alternative translation might have been "foresight principle," which has the advantage of emphasizing anticipatory action--a positive, active idea rather than precaution, which to many sounds reactive and even negative. Although the principle has its roots in German environmental policy, over the past 20 years it has served as a central element in international environmental treaties addressing North Sea pollution, ozone-depleting chemicals, fisheries, climate change, and sustainable development Sustainable development is a socio-ecological process characterized by the fulfilment of human needs while maintaining the quality of the natural environment indefinitely. The linkage between environment and development was globally recognized in 1980, when the International Union (3). Precaution is one of the guiding principles of environmental laws in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . The Precautionary Principle in Practice Historical Links The precautionary principle encourages policies that protect human health and the environment in the face of uncertain risks. In this broad sense it is not a new concept, and some may object to giving it a new name, when similar ideas go by different names in other disciplines. For example, public health practitioners use the term primary prevention to mean much the same thing. The physician's obligation to first do no harm is a precautionary approach to treating a sick person. The governments of several Scandinavian countries have made regulatory decisions about electromagnetic fields and other hazards using a concept called prudent avoidance, which is also similar (4,5). The term precautionary principle has the advantage that it provides an overarching framework that links environmental sciences and public health. Motivating Factors The precautionary principle has arisen because of the perception that the pace of efforts to combat problems such as climate change, ecosystem degradation, and resource depletion Resource depletion is an economic term referring to the exhaustion of raw materials within a region. Resources are commonly divided between renewable resources and non-renewable resources. is too slow and that environmental and health problems continue to grow more rapidly than society's ability to identify and correct them. In addition, the potential for catastrophic effects on global ecologic systems has weakened confidence in the abilities of environmental science and policy to identify and control hazards. There are also the apparent contradictions of our regulatory process: if the laws governing toxic chemical Any chemical which, through its chemical action on life processes, can cause death, temporary incapacitation, or permanent harm to humans or animals. This includes all such chemicals, regardless of their origin or of their method of production, and regardless of whether they are produced release are effective, then why are mercury levels in freshwater fish so high that pregnant women should not eat them (6,7)? How is it possible that human breast milk may not meet U.S. Food and Drug Administration Contaminant contaminant /con·tam·i·nant/ (kon-tam´in-int) something that causes contamination. contaminant something that causes contamination. limits for baby food (8,9)? The great complexity, uncertainty, and potential for catastrophe from global climate change are among the strongest motivators for those urging precaution in environmental policy. The earth warmed over the twentieth century by an estimated 0.6 [degrees] C (10). The trend was not uniform, though, and warming is occurring faster during the winter and at night (11), and the winter warming is occurring faster at high latitudes than near the tropics tropics, also called tropical zone or torrid zone, all the land and water of the earth situated between the Tropic of Cancer at lat. 23 1-2°N and the Tropic of Capricorn at lat. 23 1-2°S. (12). For human populations, the rates of change and wide swings in weather are of chief concern, as ice core records indicate that increased climatic variability may be associated with rapid climate change events and changes in the ocean thermohaline circulation thermohaline circulation: see ocean. (13). Together, warming and more extreme weather have begun to alter marine life and the weather patterns that affect infectious diseases infectious diseases: see communicable diseases. , their vectors, and hosts. The unprecedented scale of this hazard justifies reexamination re·ex·am·ine also re-ex·am·ine tr.v. re·ex·am·ined, re·ex·am·in·ing, re·ex·am·ines 1. To examine again or anew; review. 2. Law To question (a witness) again after cross-examination. of environmental monitoring systems and paradigms (14). Frustration with policy concerning toxic chemicals has also stimulated interest in the precautionary principle. The risk assessment process is perceived by a growing segment of the population as antagonistic to strong environmental protection and as excessively complex and full of hidden assumptions that have the effect of disenfranchising all but the experts from the decision-making process. Current U.S. environmental policy often seems to be more reactionary than precautionary, requiring a high degree of certainty of harm before preventive action is taken, and emphasizing the management of risks rather than their prevention. The precautionary principle, by calling for preventive action even when there is uncertainty, by placing the onus on those who create the hazard, and by emphasizing alternatives and democracy, is viewed by environmentalists as a way to shift the terms of the debate and stimulate change. Points of opposition. A lively debate is now underway about the usefulness of the precautionary principle (15-20). Perhaps the most frequently voiced criticisms are a) current regulatory procedures are already precautionary; for example, the safety factors used in risk assessments insure precaution; b) the precautionary principle is not scientifically sound because it advocates making decisions without adequate scientific justification; and c) if it were implemented, the precautionary principle would stifle innovation by requiring proof of safety before new technologies could be introduced. Each of these concerns has been addressed by proponents of the principle (21-23), and this article is not intended as a comprehensive response to critics. The objective instead is to discuss the implications of the precautionary principle for the work of environmental scientists. Case Illustrations Cellular telephones in airplanes. When the flight attendant explains the safety procedures before takeoff, there is an instruction not to use various electronic devices during takeoff and landing and not to use cellular telephones any time during flight. There is some very limited (anecdotal) evidence that these devices may interfere with the essential navigational and control systems of the aircraft. In 1999, in response to inquiries about the necessity of this ban, the U.S. Federal Aviation Administration Federal Aviation Administration (FAA), component of the U.S. Department of Transportation that sets standards for the air-worthiness of all civilian aircraft, inspects and licenses them, and regulates civilian and military air traffic through its air traffic control (FAA) commissioned a study to gather stronger evidence for or against the hypothesis that consumer electronic devices interfere with aircraft functions (24). The study failed to find any evidence of this interference. Nevertheless, the FAA ruled that, in the absence of strong evidence of safety, the ban would continue in effect. Most people agree that the inconvenience of not being able to talk on the phone in flight is offset by even a small risk of an airplane crash. This illustrates the first component of the principle: taking action in the face of uncertainty. The second aspect of precaution deals with burdens of proof, and here, too, there would probably be little controversy. Most would agree that those who would change the rule on cellular telephone use in flight should have the responsibility to show that the change will not cause unreasonable risk. But suppose concerns about portable electronic devices in airplanes had not been raised initially, and so airline passengers were currently using their cellular telephones in flight. Now suppose that a few isolated malfunctions occurred in the navigational systems of a small number of aircraft while cellular telephones were in use, and concerns were raised. Should cell phone use be banned? At that point there would be a quantifiable economic loss from ending the practice. It seems quite likely that implicitly or explicitly a cost--benefit analysis would be run, and to do this, it would be necessary to estimate the risk--something that would be, and is, very hard to do with any confidence. Some might call this approach more "science based," but it would be a highly uncertain process, and one in which the risks being evaluated might be very small, but the consequences potentially catastrophic. Fortunately, the way events have actually unfolded, it is not necessary to estimate the risk--precautionary action was taken. The availability of an economically viable alternative (in-flight telephones) may have made it easier to act in the absence of strong evidence, which highlights the potential for the precautionary principle to stimulate the search for safer technologies. Pesticides in schools. Recently the Los Angeles Unified School District The Los Angeles Unified School District (the "LAUSD") is the largest (in terms of number of students) public school system in California and the second-largest in the United States. Only the New York City Department of Education has a larger student population. , the largest public school system in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , announced a new policy on the use of pesticides in schools (25). The policy states unambiguously that pesticides pose risks to the health of children and the environment, that they shall be used only after nonchemical methods have been considered, and that if there is a choice among pest control pest control n → control m de plagas pest control n → lutte f contre les nuisibles pest control pest n methods, the least harmful one shall be chosen. There is no mention of balancing risks and benefits, nor a list of banned substances. The precautionary principle is a long-term objective of the policy, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. its authors. Critics worry that the precautionary principle will encourage technology choices based on fear and emotions, rather than on science. But another interpretation would be that the Los Angeles Unified School District is saying that all pesticides should be assumed to be hazardous, while acknowledging a great deal of uncertainty about exactly how hazardous. The intention to prefer nonchemical methods and to choose the least toxic method encourages a search for alternatives, while at the same time not preventing the use of a toxic chemical if it is found to be necessary and irreplaceable. The new policy also requires consideration of the service or function that a pesticide provides. For example, a pesticide being used for aesthetic purposes may be determined to be less important than one that serves a hygienic hy·gien·ic adj. 1. Of or relating to hygiene. 2. Tending to promote or preserve health. 3. Sanitary. function. The former may be more readily eliminated than the latter, if no alternative can be found. Polyvinyl chloride polyvinyl chloride (PVC), thermoplastic that is a polymer of vinyl chloride. Resins of polyvinyl chloride are hard, but with the addition of plasticizers a flexible, elastic plastic can be made. toys. Polyvinyl chloride (PVC PVC: see polyvinyl chloride. PVC in full polyvinyl chloride Synthetic resin, an organic polymer made by treating vinyl chloride monomers with a peroxide. ) is an extremely versatile material, made into thousands of products. By adding varying amounts of a chemical called a plasticizer plas·ti·ciz·er n. Any of various substances added to plastics or other materials to make or keep them soft or pliable. plasticizer or -ciser Noun , the pliability pli·a·ble adj. 1. Easily bent or shaped. See Synonyms at malleable. 2. Receptive to change; adaptable: pliable attitudes. 3. Easily influenced, persuaded, or swayed; tractable. of PVC can be modified from hard and brittle to soft and almost spongy spongy /spon·gy/ (spun´je) of a spongelike appearance or texture. spong·y adj. Resembling a sponge in appearance, elasticity, or porosity. . There is evidence that several of the plasticizers plasticizers mostly triaryl phosphates, such as tricresyl, triphenyl phosphates, which are poisonous. See also triorthocresyl phosphate. , members of the phthalate Phthal´ate n. 1. (Chem.) A salt of phthalic acid. chemical family, are reproductive toxicants in animals. They may also cause reproductive toxicity reproductive toxicity Any adverse effect attributable to exposure to a chemical, directed against the reproductive and/or related endocrine systems Adverse effects Altered sexual behavior, fertility, pregnancy outcomes, or modifications in other functions that in humans, although this evidence is quite limited (26-28). Until 1999, many PVC plastic toys Plastic Toys are an electro-rock band formed in late 2003 based in Southampton, UK. The 4-piece group are made up of Jon Plastic (Vocals/Guitars), Kitty Brooks (Bass), Si Jackson (Guitars) and Ben Coley (Drums). specifically designed to be sucked and chewed contained the plasticizer diisononyl phthalate. Many of the manufacturers of toys that formerly contained this chemical have now voluntarily stopped using this plasticizer, or in some instances completely phased out PVC in these toys, in response to consumer and government concerns about toy safety The examples and perspective in this article or section may not represent a worldwide view of the subject. Please [ improve this article] or discuss the issue on the talk page. . But the evidence for human health risks is weak and uncertain. Producers of PVC products have argued that there is no evidence of harm from use of their products, given 40 years of use without apparent ill effects. There is a flaw in this reasoning, however, because the absence of evidence of harm is not the same thing as evidence of the absence of harm. Of course, absolute safety can never be proven. But a lengthy and costly risk assessment, followed by an equally lengthy and acrimonious risk management process would be the likely outcome of the present one-substance-at-a-time approach to chemicals policy. The precautionary principle seeks to minimize the limitations of a risk assessment-based regulatory policy by encouraging a search for alternatives whenever a potentially hazardous chemical is identified. If a clearly safer alternative exists, why accept even a small, highly uncertain risk? The Danish Environment Agency used just this logic in taking action to eliminate phthalates Phthalates, or phthalate esters, are a group of chemical compounds that are mainly used as plasticizers (substances added to plastics to increase their flexibility). They are chiefly used to turn polyvinyl chloride from a hard plastic into a flexible plastic. from toys (29). They said, in essence, that there is exposure to these compounds, there is animal toxicity data, the exposure is to children who by definition are particularly susceptible to many toxic substances, there are alternatives, and the product serves no necessary function. Considering all these factors, they concluded that the plasticizer should not be used in toys. Limitations of Conventional Scientific Methods Environmental scientists study highly complex, poorly understood systems. Often the most informative experiments cannot be conducted for logistical or ethical reasons (there is only one Atlantic Ocean Atlantic Ocean [Lat.,=of Atlas], second largest ocean (c.31,800,000 sq mi/82,362,000 sq km; c.36,000,000 sq mi/93,240,000 sq km with marginal seas). Physical Geography Extent and Seas to study; potential carcinogens Carcinogens Substances in the environment that cause cancer, presumably by inducing mutations, with prolonged exposure. Mentioned in: Colon Cancer, Rectal Cancer cannot be administered to humans in double-blind trials). At the same time, this work is of great interest to those who seek to balance economic growth and environmental protection. In this complicated and contested terrain, it is useful to examine the methodologies of science and to consider ways that, without compromising integrity and objectivity, research can be more or less helpful to those who would act with precaution. It would, for example, be useful to policy makers if scientists were more explicit about the limits of knowledge and about the nature and amount of uncertainty in research findings. Presented below are examples of the ways that science is currently conducted that may make it more difficult to set precautionary policies. There may be alternatives to these methods, well within the bounds of good practice, that would be more helpful to policy makers faced with high-stakes decisions and great scientific uncertainty. Hypothesis Formulation Einstein said that the theory decides what can be observed, and at the more practical level, the formulation of specific research hypotheses determines to a large degree the sorts of results that can be found. Where does the particular formulation of a hypothesis come from? Often the hypothesis is formulated in a way that is feasible to test with the time and resources available. There is also a tendency for researchers to refine understanding of old problems rather than risk investigating new ones (30). Greater and greater levels of detail are sought about well-defined problems, rather than the higher stakes enterprise of searching for entirely new phenomena. For example, we refine understanding of the mechanisms of toxicity of asbestos, lead, and polychlorinated biphenyls polychlorinated biphenyls, (pol´ēklôr´ Emphasis on Independent Effects, Not Interactions There is a tendency to assume that the mechanisms underlying the phenomena being studied are driven primarily by the independent actions of a few causal factors. If they interact, this is assumed to be of secondary importance. This implicitly assumes that things are not connected and leads to an atomized worldview world·view n. In both senses also called Weltanschauung. 1. The overall perspective from which one sees and interprets the world. 2. A collection of beliefs about life and the universe held by an individual or a group. . In reality, complex biological systems such as ecosystems, human populations, or individual physiology are composed of feedback loops and other interactions which make cause-effect relationships far from direct or linear. But many times the effects of hypothesized causal factors are considered in research to be decomposable de·com·pose v. de·com·posed, de·com·pos·ing, de·com·pos·es v.tr. 1. To separate into components or basic elements. 2. To cause to rot. v.intr. 1. into additive components that are measured individually. For example, when studying a mixture of pollutants, the emphasis is on identifying which component of the mixture is problematic. Interactions are difficult to study, but this should be seen as a challenge to develop more sensitive and complex methods, rather than as an inherent limitation of science. Narrow Definition of Uncertainty The formal evaluation of error or uncertainty in many environmental science papers is limited to a presentation of p-values or confidence intervals for the main results. Beyond this, there may be a qualitative examination of limitations of the findings, which is relegated to the discussion section at the end of the paper. The standard p-values and confidence intervals indicate the magnitude of potential error in the statistical parameter A statistical parameter is a parameter that indexes a family of probability distributions. Among parameterized families of distributions are the normal distributions, the Poisson distributions, the binomial distributions, and the exponential distributions. estimates due strictly to sampling variability. But in observational studies observational studies, n.pl an investigational method involving description of the associations be-tween interventions and outcomes. Outcomes research and practice audits are examples of this investigational method. of complex, poorly understood systems, this may be the least important source of uncertainty. Potentially more important are errors in the independent variables, errors arising from choice of the wrong form for the model(s) used to analyze and interpret the data, and biases from problems in the conduct of the study. For example, a study of the effects of an environmental contaminant on reproductive success Reproductive success is defined as the passing of genes onto the next generation in a way that they too can pass those genes on. In practice, this is often a tally of the number of offspring produced by an individual. in fish would typically report the amount of sampling error around the final estimate of the degree of association found between the contaminant and the measure of reproductive behavior Reproductive behavior Behavior related to the production of offspring; it includes such patterns as the establishment of mating systems, courtship, sexual behavior, parturition, and the care of young. . But this would typically not take into consideration the error in measuring the levels of the contaminant in the fish or in the environment and would not investigate the sensitivity of the findings to the choice of statistical models used to link exposure with reproductive outcome. It is sometimes argued that scientists are trained to read papers critically and that they are able to factor in these other sources of uncertainty in their evaluation of a study. But applied scientists are also communicating to nonscientists who may mistakenly take the limited characterization of sampling error as the best estimate of all the uncertainty. Setting Type I and Type II Error Rates Errors due to sampling variability are routinely quantified. However, standard practice has led to a conservatism that perhaps hinders precautionary action. When a scientific investigation is designed to test a hypothesis, there are two kinds of errors that one seeks to minimize. A Type I error is the mistake of concluding that a phenomenon or association exists when in truth it does not. (Technically, the Type I error is rejecting the null hypothesis null hypothesis, n theoretical assumption that a given therapy will have results not statistically different from another treatment. null hypothesis, n when it is really true. The paraphrasing above, while valiantly railed against by statistics teachers everywhere, is the way it is thought of in everyday practice.) By convention, Type I (or alpha) errors are guarded against by setting that error rate low, usually at 5%. In other words Adv. 1. in other words - otherwise stated; "in other words, we are broke" put differently , the finding must be so strong that there is less than a 5% probability that this result would have been seen by chance alone in a world in which no such phenomenon actually exists. In this case the result is called statistically significant (with the clear implication that one is supposed to believe it). The Type II error, failing to detect something that actually does exist, is, by convention, often set at 20% (although practical limitations of sample size often result in a substantially higher or lower Type II error). Twenty percent of the time, a real phenomenon will be missed because the data were not strong enough to convincingly demonstrate its existence. There is an implicit bias here: the test is set up to be more cautious about falsely detecting something than about failing to detect something. Should Type I and Type II error rates be set explicitly and a priori a priori In epistemology, knowledge that is independent of all particular experiences, as opposed to a posteriori (or empirical) knowledge, which derives from experience. , depending on the purposes that the study is meant to serve? Bayesian statistical methods promise a way out of these conundrums by shifting the focus from formal testing to calculating the weight of evidence provided by a particular study and the degree to which this study should shift a priori beliefs. At present, Bayesian methods are little used in practice, but research to make them more accessible and practical is now under way (31-33). Type III Type III may stand for:
A Type III error occurs when one provides an accurate answer to the wrong problem (34). The cliche about looking under the street light for the keys lost down the block (because the light is better there) comes to mind to illustrate this common problem. To some degree, this is another aspect of hypothesis formulation discussed above. Citizen groups who ask a scientist for help with a particular environmental concern frequently experience the consequence of Type III errors. The citizens have a broad concern about, for example, potential health effects of a power plant in the neighborhood. The scientist hears the concern, and translates it into a problem that he or she is able to solve with the tools at hand, such as, do the power plant emissions exceed current health standards? This translation almost inevitably narrows the focus to something manageable and solvable. But often the citizens are frustrated with the results because scientists did not adequately address the initial concerns. On the other hand, the scientist is puzzled or, worse, concludes that the citizens are "antiscience." Disciplinary Divisions The citizens group's concerns about the power plant would probably be better addressed by an interdisciplinary investigation, using a wide variety of different methods and looking for Looking for In the context of general equities, this describing a buy interest in which a dealer is asked to offer stock, often involving a capital commitment. Antithesis of in touch with. an integrated understanding of the facility's impacts. Traditional boundaries between academic disciplines make it difficult to bring together the broadest possible set of research tools; combining for example quantitative and qualitative methods. Scientific Methods to Inform Precautionary Policy As noted at the beginning of this paper, science plays a critical role in environmental policy by providing insights into the normal functioning of natural systems and the ways they are disrupted by technologies and other human activities. Environmental scientists use a wide variety of methods, and these are to a large degree determined by the problem at hand. In some fields, prediction is an essential part of scientific proof. In others, it is useless or impractical. The simple accumulation of confirming cases is of no use in fields that hold to a high standard of mathematical proof Noun 1. mathematical proof - proof of a mathematical theorem proof - a formal series of statements showing that if one thing is true something else necessarily follows from it , and in some disciplines controlled experiments are essential. But in many environmental sciences where observational studies are the rule, experiments are often infeasible or unethical, and it is impractical to wait to see if predictions are borne out. Other types of evidence are used, and usually sufficient proof for action comes from the accumulation of plausible inference from independent lines of work. For instance, environmental causes of cancer may be identified from the geographic distributions of cancers; time trends in cancer frequency; the occurrence of cancers in highly exposed working populations; animal experiments; and experimental knowledge of chemical pathways of cancer induction. And once it is demonstrated that a particular molecule is carcinogenic carcinogenic having a capacity for carcinogenesis. , similar molecules are at least suspect. Any one line of argument is imperfect, and fault can be found with the details of most separate methods. It is the preponderance of evidence A standard of proof that must be met by a plaintiff if he or she is to win a civil action. In a civil case, the plaintiff has the burden of proving the facts and claims asserted in the complaint. that finally prevails. It is never easy to determine the moment in this process when there is sufficient evidence to act as if a causal connection exists, but scientists can and should play an important role in this decision, as they are the ones who know the data and the methods best. A shift to more precautionary policies creates opportunities and challenges for scientists to think differently about the way they conduct studies and communicate results. The following paragraphs briefly summarize some of the positive implications that such a policy shift might have for the conduct of science. What Is Studied There is a great need for better methods to study whole systems and the interactions of various causal factors. The cumulative and interactive effects of multiple insults on an organism or ecosystem are very difficult to study. There are often many levels of a system (individuals, families, communities, nations), and hazards often exert effects at multiple levels. Current methods in many disciplines are not well suited to such investigations. As noted above, multidisciplinary teams will be more likely to find new ways to frame hypotheses that lead to insights not possible from narrow disciplinary viewpoints. The recent recognition of the problem of endocrine disruption provides an example. A review of many different types of evidence on the effects of persistent pollutants on wildlife in the Great Lakes Great Lakes, group of five freshwater lakes, central North America, creating a natural border between the United States and Canada and forming the largest body of freshwater in the world, with a combined surface area of c.95,000 sq mi (246,050 sq km). led to the hypothesis that a common mechanism of action might be causing a variety of reproductive and developmental effects (35,36). Because of the fragmentation of scientific disciplines, no single researcher was able to develop a coherent hypothesis. An interdisciplinary conference (35) provided the opportunity for many different fields to meet and share insights. The conference organizers summarized the outcome (35): so shocking was this revelation [about the widespread observation of endocrine disruption in wildlife] that no scientist could have expressed the idea using only the data from his or her discipline alone without losing the respect of his or her peers. Research Methods Uncertainty is a positive aspect of knowledge because it clarifies what is known and unknown and thus stimulates further investigation. But there is also a strong desire on the part of scientists to be precise. This may result from a confusion of uncertainty of information with quality of information; but the two concepts are distinct (37). It is possible to produce high-quality information about greatly uncertain phenomena. Most scientists are aware that their p-values and confidence intervals do not fully capture all of the likely error in their results, but standard methods do not exist for characterizing other aspects of uncertainty. There is a great need for research to find ways to characterize, express, and communicate uncertainty. Scientists develop intuition or professional judgment about the strength of a particular result. The Bayesian view of statistical inference Inferential statistics or statistical induction comprises the use of statistics to make inferences concerning some unknown aspect of a population. It is distinguished from descriptive statistics. , an increasingly popular alternative to standard frequentist methods, acknowledges that we have beliefs about the phenomena under study and seeks to formalize the role these play in the way we view our data (32). The role of data, according to this perspective, is to shift our a priori beliefs about the phenomena under study. Strong results may shift beliefs a lot, producing a posterior probability The posterior probability of a random event or an uncertain proposition is the conditional probability that is assigned when the relevant evidence is taken into account. that may be far from the prior probability prior probability, n the extent of belief held by a patient and practitioner in the ability of a specific therapeutic approach to produce a positive outcome before treatment begins. that the researcher had assigned to the hypothesis before conducting the research. But weak data will have little impact, leaving posteriors close to priors. There is increasing awareness that Bayesian statistical methods correspond more closely to common approaches to logical inference in everyday life. Methods development work is still needed in most fields, however, before Bayesian statistics can be routinely applied. Uncertainties that derive from the choice of research methods and mathematical models should also be more fully investigated and discussed. Formal sensitivity analyses in which the investigator assesses the degree to which results are changed by using different assumptions or analytic methods should become standard practice (38). Current methods seldom encourage a search for patterns within noisy data and "clusters of clusters" of similar effects in different species. Conservation medicine is a new academic initiative that links human and animal health with ecosystem health and global change (39). It begins from the premise that the health of ecosystems is directly related to the health of species, including humans. The initiative arose from a growing understanding that human impacts on ecosystems were multiple and integrated. Conservation medicine uses interdisciplinary teams of veterinary and medical health professionals to develop a greater understanding of the ecological context of health and advance biodiversity conservation and ecosystem health. If society chooses to act with incomplete information, it must be acknowledged that one kind of risk is being accepted to avoid another. One risk being accepted is that the policy choice may have been wrong. Fortunately, the effects of a policy can often be evaluated for beneficial or detrimental unintended consequences For the "Law of unintended consequences", see Unintended consequence Unintended Consequences is a novel by author John Ross, first published in 1996 by Accurate Press. . Thus a strong environmental monitoring program and formal evaluations of the interventions or controls are essential parts of a policy of precaution (40). Despite the need for more and better systems research, it remains true that much useful information is learned by taking a system apart and testing its components. The development of new approaches should supplement current scientific methods, not replace them. There is also an important role for those who can synthesize the results of the work of many disparate disciplines to reach insights not possible by the individual researchers. This has been called "joining edge" research (as opposed to "cutting edge"). Conclusions and Recommendations It is important to clearly distinguish between the development of scientific information about an issue and the, setting of policy, but in practice, there is not always an unambiguous demarcation. Policy makers set agendas that determine the questions asked of scientists; scientists formulate hypotheses in ways limited by their tools and their imaginations; thus, the information they provide to the policy makers is limited and to a degree socially determined. There is a complicated feedback relation between the discoveries of science and the setting of policy. While maintaining their objectivity and focus on understanding the world;environmental scientists should be aware of the policy uses of their work and of their social responsibility to do science that protects human health and the environment (14). The precautionary principle highlights this tight, problematic linkage between science and policy, which can be summarized in the following seven points: 1. Scientific studies can tell us something about the costs, risks, and benefits of a proposed action, but there will always be value judgments that require political decisions. 2. The scientific data used for making policy will nearly always be limited by uncertainty. Even the best theory and data will leave much that is not known about estimates of risks, benefits, or costs. 3. In conducting their research, scientists must make assumptions, choices, and inferences based on professional judgment and standard practices, that if not known by the public or policy makers, may make scientific results appear to be more certain and less value laden than is warranted. 4. Although there are some situations in which risks clearly exceed benefits no matter whose values are being considered, there is usually a large gray area in which science alone cannot (and should not) be used to decide policy. 5. In these gray areas, status quo [Latin, The existing state of things at any given date.] Status quo ante bellum means the state of things before the war. The status quo to be preserved by a preliminary injunction is the last actual, peaceable, uncontested status which preceded the pending controversy. activities that potentially threaten human and environmental health are often allowed to continue because the norms of traditional science demand high confidence in order to reject null hypotheses, and so detect harmful effects. 6. This scientific conservatism is often interpreted as favoring the promoters of a potentially harmful technology or activity when the science does not produce overwhelming evidence of harm. 7. The precautionary principle, then, is meant to ensure that the public good is represented in all decisions made under scientific uncertainty. When there is substantial scientific uncertainty about the risks and benefits of a proposed activity, policy decisions should be made in a way that errs on the side of caution with respect to the environment and the health of the public. REFERENCES AND NOTES (1.) 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It was established in 1970 to reduce and control air and water pollution, noise pollution, and radiation and to ensure the safe handling and , 1997. (7.) Schettler T. In Harm's Way harm's way n. A risky position; danger: a place for the children that is out of harm's way; ships that sail into harm's way. : Toxic Threats to Child Development. Boston:Greater Boston Greater Boston is the area of the Commonwealth of Massachusetts surrounding the city of Boston, Massachusetts. While Metro Boston tends to be the "Inner Core" surrounding the City of Boston, Greater Boston overlaps the North and South Shores, as well as the MetroWest region. Physicians for Social Responsibility, 1997. (8.) Abadin HG, Hibbs BF, Pohl HR. Breast-feeding breast-feeding /breast-feed·ing/ (brest´fed?ing) nursing; the feeding of an infant at the mother's breast. exposure of infants to cadmium, lead and mercury: a public health viewpoint. Toxicol Ind Health 13:495-517 (1997). (9.) Pohl HR, Hibbs BF. Breast-feeding exposure of infants to environmental contaminants--a public health risk assessment viewpoint: chlorinated chlorinated /chlo·ri·nat·ed/ (klor´i-nat?ed) treated or charged with chlorine. chlorinated charged with chlorine. chlorinated acids some, e.g. dibenzodioxins and chlorinated debenzofurans. Toxicol Ind Health 12:593-611 (1996). (10.) Albritton D, Allen M, Baede A, Church JA, Cubasch U, Xiaosu D, Yihui D, Ehhalt DH, Folland CK, Giorgi F, et al. Summary for Policymakers: A Report of Working Group 1 of the Intergovernmental Panel on Climate Change “IPCC” redirects here. For other uses, see IPCC (disambiguation). The Intergovernmental Panel on Climate Change (IPCC) was established in 1988 by two United Nations organizations, the World Meteorological Organization (WMO) and the United Nations Environment . Geneva:intergovernmental Panel on Climate Change, 2001. Available: http://www.ipcc.ch/pub/spm22-01.pdf [cited 19 July 2001]. (11.) Easterling DR, Horton B, Jones PD, Paterson TC, Karl TR, Parker DE, Salinger MJ, Razuvayev V, Plummer N, Jameson P, Folland CK. Maximum and minimum temperature trends for the globe. Science 277:363-367 (1997). (12.) Intergovernmental Panel on Climate Change. Climate Change '95: The Science of Climate Change. Contribution of Working Group I to the Second Assessment Report of the IPCC. (Houghton JT, Meiro Filho LG, Callander GA, Harris N, Kattenberg A, Maskell K, eds). Cambridge:Cambridge University Press Cambridge University Press (known colloquially as CUP) is a publisher given a Royal Charter by Henry VIII in 1534, and one of the two privileged presses (the other being Oxford University Press). , 1996. (13.) Paul Meyewski. Personal communication. (14.) Lubchenco J. Entering the century of the environment: a new social contract for science. Science 279:491-497 (1998). (15.) Bishop W, Risk assessment vs. the precautionary principle: is it really either/or? Risk Policy Report (20 March):35-38 (2000). (16.) CEC (Central Electronic Complex) The set of hardware that defines a mainframe, which includes the CPU(s), memory, channels, controllers and power supplies included in the box. Some CECs, such as IBM's Multiprise 2000 and 3000, include data storage devices as well. . Communication from the Commission on the Precautionary Principle. COM (1) (Computer Output Microfilm) Creating microfilm or microfiche from the computer. A COM machine receives print-image output from the computer either online or via tape or disk and creates a film image of each page. (2000) 1. Brussels: Commission of the European Community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. , 2000. (17.) Holm S, Harris J. Precautionary principle stifles discovery [Letter]. Nature 400:398 (1999). (18.) Stirling A. On Science and Precaution in the Management of Technological Risk. EUR EUR In currencies, this is the abbreviation for the Euro. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 19056 EN. Sevilla, Spain:European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community Institute for Prospective Technological Studies The Institute for Prospective Technological Studies or IPTS, located in Sevilla, Spain, is one of the seven institutes of the Joint Research Centre (JRC), a Directorate-General of the European Commission (EC). , 2000. Available: http://www.jrc.es/ cfapp/reports/details.cfm?ID=289 [cited 2 July 2001]. (19.) Danish Environmental Protection Agency. The Precautionary Principle: Extracts and Summary from the Danish Environmental Protection Agency's Conference on the Precautionary Principle. Environment News No. 35. Copenhagen:Danish Environmental Protection Agency, 1998. (20.) Applegate J. The precautionary preference: an American perspective on the precautionary principle. Hum Ecol Risk Assess 6:413-443 (2000). (21.) Wynne B, Mayer S. How science fails the environment. New Scientist 138:33-35 (1993), (22.) Ashford N. A conceptual framework For the concept in aesthetics and art criticism, see . A conceptual framework is used in research to outline possible courses of action or to present a preferred approach to a system analysis project. for the use of the precautionary principle in law. In: Protecting Public Health and the Environment: implementing the Precautionary Principle (Raffensperger C, Tickner J, eds). Washington, DC:Island Press, 1999;198-206. (23.) Myers N. Debating the Precautionary Principle. Windsor, ND:Science and Environmental Health Network, 2000. Available: http://www.sehn.org/ppdebate.html [cited 2 July 2001]. (24.) Portable Electronic Devices: Hearings before the U.S. House of Representatives Committee on Transportation and Infrastructure, Subcommittee on Aviation, 106th Congress, 2nd Session, 20 July 2000, (statement of Captain P. McCarthy, T.E. McSweeny, and D.S D.S Drainage Structure (flood protection) . Watrous). (25.) Preferring the Least Harmful Way. Rachel's Environment and Health Weekly 684 (2000). Available: http:// www.rachel.org/bulletin/index.cfm?issue_ID=1687 [cited 3 July 2001]. (26.) NTP-CERHR. NTP-CERHR Expert Panel Report on Di(2-ethylhexyl)phthalate. NTP-CERHR-DEHP-00. Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , NC:National Toxicology Program National Toxicology Program Environment A program that conducts toxicologic tests on substances frequently found at the EPA's National Priorities List sites, which have the greatest potential for human exposure , Center for the Evaluation of Risks to Human Reproduction The National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences (NIEHS) established the NTP Center for the Evaluation of Risks to Human Reproduction in 1998 as an environmental health resource to the public and regulatory and health agencies. , 2000. Available: http://cerhr.niehs.nih.gov/news/DEHP-final.pdf [cited 19 July 2001]. (27.) European Scientific Committee on Toxicity, Ecotoxicity, end the Environment. Opinion on Phthelate Migration from Soft PVC Toys and Childcare Articles. Available: http://europa.eu.int/comm/food/fs/sc/sct/out19_en.html [cited 3 duly 2001]. (28.) Tickner J, Schettler T, Guidotti T, McCally M, Rossi M. Health risks posed by the use of di-2-ethylhexyl phthalate in PVC medical devices: a critical review. Am J Ind Med 39:100-111 (2001). (29.) Seedorf L. Personal communication. (30.) Kuller L. Invited commentary: circular epidemiology. Am J Epidemiol 150:897-903 (1999). (31.) Malakoff D. Bayes offers a new way to make sense of numbers. Science 286:1460-1464 (1999). (32.) Carlin car·line or car·lin n. Scots A woman, especially an old one. [Middle English kerling, from Old Norse, from karl, man.] B, Louis T. Bayes and Empirical Bayes Methods for Data Analysis. New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of :Chapman and Hall Chapman and Hall was a British publishing house, founded in the first half of the 19th century by Edward Chapman and William Hall. Upon Hall's death in 1847, Chapman's cousin Frederic Chapman became partner in the company, of which he became sole manager upon the retirement of , 1996. (33.) Greenland S, Poole C. Empirical Bayes and semi-Bayes approaches to occupational and environmental hazard 'Environmental hazard' is a generic term for any situation or state of events which poses a threat to the surrounding environment. This term incorporates topics like pollution and Natural Hazards such as storms and earthquakes. surveillance. Arch Environ Health 49:9-16 (1994). (34.) Schwartz S, Carpenter K. The right answer for the wrong question: consequences of type III error for public health research. Am J Public Health 89:1175-1180 (1999). (35.) Colborn T, Clement C, eds. Chemically-Induced Alterations in Sexual and Functional Development: The Wildlife/ Human Connection. Princeton, NJ:Princeton Scientific Publishing Co., 1992. (36.) Krimsky S. Hormonal Chaos. Baltimore, MD:Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. Press, 1999. (37.) Funtowicz S, Ravetz J. Uncertainty and Quality in Science for Policy. Dordrecht, Netherlands:Kluwer Academic, 1990. (38.) Greenland S. Basic methods for sensitivity analysis of biases. Int J Epidemiol 25:1107-1116 (1996). (39.) Tufts Center for Conservation Medicine. Introducing the Center for Conservation Medicine. North Grafton, MA: Tufts University Tufts University, main campus at Medford, Mass.; coeducational; chartered 1852 by Universalists as a college for men. It became a university in 1955. Jackson College, formerly a coordinate undergraduate college for women, merged with the College of Liberal Arts in Veterinary School Noun 1. veterinary school - a school teaching veterinary medicine school - an educational institution; "the school was founded in 1900" , 1999. Available: http://www.tufts.edu/vet/ccm/introtccm.html [cited 3 July 2001]. (40.) Goldstein B. The precautionary principle and scientific research are not antithetical an·ti·thet·i·cal also an·ti·thet·ic adj. 1. Of, relating to, or marked by antithesis. 2. Being in diametrical opposition. See Synonyms at opposite. [Editorial]. Environ Health Perspect 107:A594-595 (1999). David Kriebel, (1) Joel Tickner, (1) Paul Epstein For other persons named Paul Epstein, see Paul Epstein (disambiguation). Paul Epstein (Frankfurt, July 24, 1871 – Dornbusch, August 11, 1939) was a German mathematician. He is known for his contributions to number theory, in particular the Epstein zeta function. , (2) John Lemons, (3) Richard Levins Richard "Dick" Levins is a mathematical ecologist, and political activist. He is most famous for his work on evolution in changing environments. Levins' writing and speaking is extremely condensed. , (4) Edward L. Loechler, (5) Margaret Quinn, (1) Ruthann Rudel, (6) Ted Schettler, (7) and Michael Stoto (8) (1) Lowell Center for Sustainable Production, Department of Work Environment, University of Massachusetts-Lowell, Lowell, Massachusetts, USA; (2) Center for Health and the Global Environment, Harvard University Medical School, Boston, Massachusetts, USA; (3) Department of Life Sciences, University of New England The University of New England can refer to:
Address correspondence to D. Kriebel, Lowell Center for Sustainable Production, University of Massachusetts Lowell UMass Lowell was named the University of Lowell from 1975 to 1991, and was created from the merger of the Lowell Technological Institute and Lowell State College in 1975. These colleges in turn were originally named the Lowell Textile School, founded in 1895 to train technicians and , 1 University Avenue, Lowell, MA 01854 USA. Telephone: (978) 934-3250. Fax: (978) 452-5711. E-mail: David_Kriebel@uml.edu We thank C. Crumbley for her assistance with this project. This work was supported in part by grants from the John Merck Fund, the Jessie B. Cox Charitable Trust The arrangement by which real or Personal Property given by one person is held by another to be used for the benefit of a class of persons or the general public. , the New York Community Trust New York Community Trust was founded in 1924 by a group of New York bankers. It is one of the oldest and largest community foundations in the United States with 2006 assets of over $1.9 billion. , the V. Kann Rasmussen Foundation, and the Mitchell Kapor Foundation. Received 12 February 2001; accepted 28 February 2001. |
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