Precaution and Endocrine Disruption - May 1997
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| I. | Editor's Note - Floods And Chickens In The Shade | Carolyn Raffensperger |
| II. | The Precautionary Principle | Joel Tickner |
| III. | A Proposal For Global Research On Endocrine Disrupting Chemicals From the World Wildlife Fund | SEHN |
| IV. | Letters To The Editor | Cameron Davis Bruce Hannon Reader Responses |
| V. | News Briefs | SEHN |
| I. Editor's Note: Floods And Chickens In The Shade | TOP |
| By Carolyn Raffensperger
Sending this by electronic mail creates the illusion that it doesn't come from a real place, nor is it sent by real people. Without labels on it that say "chlorine-free, 100% recycled post-consumer waste" and a return address that says "Windsor North Dakota", its tempting to assume that the electrons generate themselves. But they don't.I edit the Networker from North Dakota, land of the Great Flood and Good People. The last issue was created on days when we had no running water, no electricity and couldn't travel because the roads were under water. Only a few of our cattle died, although neighbors lost entire herds. I wonder, as many people do (including President Clinton), whether this terrible winter and desperate spring were caused by global warming. Science can't really give us an answer to that. Causation on this scale isn't easily roved, whether it is global warming and storms, or chemicals and endocrine disruption, or holes in the ozone layer and crop damage.
Last weekend I visited friends who are organic farmers. We were discussing endocrine disruption and why we shouldn't burn plastics on the farm. Most of us don't have garbage pick-up so we are careful about what we bring onto our land and what we do with it. But plastics are ubiquitous and a real hazard. In the midst of this conversation my friend David Podoll said he thought the biggest threat to life was the sun. I couldn't even imagine what he was talking about. He described a day some years ago when he was watching his chickens. It was 50*F outside, a temperature when chickens like to be out in the sun spreading their feathers and getting some warmth. The chickens were in the shade, an unnatural behavior at that temperature. David began correlating chickens in the shade with the ultraviolet readings that were provided for our part of the world. Chickens sought shade when the readings were high even though the temperature was cool. He had also observed that in some plants like potatoes, the plants with the darkest, richest green leaves were suffering the most disease and insect damage. He surmised that like the chickens, they were being harmed by the ultraviolet rays which left them vulnerable to other problems. What do floods and chickens in the shade have to do with science? Everything. They give us room to ask the question, "in the face of scientific uncertainty and these serious environmental threats, how should we then act?" The articles in this issue give two responses: act with precaution and do more research. They go hand in hand. Act with precaution first. Then set up the elegant studies. We may never prove causation, but the costs for the damage are unbearable. Ask us, we live in North Dakota.
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| II. The Precautionary Principle | TOP |
| By Joel Tickner
During the past twenty-five years, government agencies in the United States have used decision-making instruments to assess, control, and prevent the environmental and public health effects associated with synthetic chemicals. These instruments, including cost-benefit analysis, epidemiology, and risk assessment, have been used to make risk-based decisions. While these instruments have been used successfully to control certain hazards, the incidence of environmentally and occupationally related disease in humans remains significant.
Current environmental decision-making processes suffer from several constraints, which limit our ability to identify, anticipate, and prevent potential harm to human health and the environment. Decisions to take action to limit hazardous substances are often made only in response to the scientific establishment of a causal link between a substance and a specific harm. Proving cause takes extensive time and resources. Among the difficulties in proving cause are: 1. Limitations in scientific knowledge. The capacity to identify and prevent potential harmful environmental effects is limited by the present state of scientific knowledge. Scientific knowledge is especially limited in understanding the variability and effects of pollution on ecosystems. The ability of science to identify a threshold for effects or an assimilative capacity for an ecosystem is limited by deficiencies in data; of knowledge about processes in humans and nature; the effects of chemical mixtures and other stressors; variation in exposure; and the time lag between exposure and effects (Gee, 1994). Waiting for convincing human evidence can pose high human health and ecological costs. 2. Problems of statistical power. Regulatory programs often fail to consider statistical power in decision making. Statistical power describes in mathematical terms the probability of an experiment or monitoring program actually detecting an effect where one exists (McGonigle, et al., 1994). This lack of attention to statistical power leads to experimental approaches that minimize the probability of incorrectly concluding that there is an effect when one does not exist, termed a type I error. This type of error would lead an agency to erroneously impose regulation. However, this focus on minimizing type I errors necessarily increases the probability of type II errors, concluding that there is no effect when one actually exists. A type II error would lead to a failure to prevent an adverse effect. Thus, experiments that fail to find an effect may erroneously conclude the null hypothesis, that no adverse effect exists, when the experimental design lacks sufficient statistical power to identify an effect in the first place. This problem raises a fundamental question with regard to experimental methods: Is absence of evidence of harm the same as evidence of absence? Safe application of a threshold for adverse effects relies on an ability to prove the null hypothesis, a no effect level for those effects. 3. Low-level adverse effects. Evidence regarding the effects of several classes of chemical compounds at low levels of exposure is slowly evolving. For example, dioxins, a highly studied class of compounds, cause adverse effects in the range of parts per quadrillion (U.S. EPA, 1994). Evidence regarding the endocrine disrupting ability of certain synthetic compounds has shown that even very low level exposures, during certain periods of development, can cause wide ranging reproductive and developmental effects (Colborn and Clement, 1992). Contrary to the expected pattern, research has shown that some of these effects occur at low levels of exposure and not at high levels (Colborn, Dumanoski and Myers, 1996). Low level adverse effects pose several difficulties: Monitoring and control of industrial emissions at very low exposure levels is technically difficult and subject to wide uncertainties. If adverse effects are being observed at very low levels of exposure, there is reason to believe that similar effects may occur at even lower (but still unmeasurable levels of exposure. 4. Difficulties in addressing cumulative effects. Traditional decision making strategies have focused on single chemical, single medium effects, when, in reality, humans and ecosystems are exposed to a wide variety of physical and chemical stressors. The way we monitor exposure and effects fails to consider the cumulative effects of multiple physical and chemical stressors, leading to underestimates of potential adverse effects. 5 . Financial and resource limitations. More than 70,000 chemicals are currently used in commerce, while only several hundred are regulated worldwide, and less than 10% have been adequately tested for effects on humans and the environment. The costs and time associated with chemical testing and environmental monitoring (e.g., identifying or disproving adverse effects) inhibit the comprehensive evaluation of all hazards prior to commercializing a chemical or approving an activity. These costs have, in part, led to a decision-making and policy emphasis on quantification of hazards rather than fundamental prevention. These limitations in current decision-making techniques lead to the question: How can preventive policies to protect human health and the environment be developed in the face of significant scientific uncertainty regarding cause-effect relationships or the extent of potential damage? The Precautionary Approach Given the limitations of science to address emerging environmental problems, such as endocrine disruption, there is a significant need for the development of new public policy approaches to anticipate and prevent harm to human health and the environment. The question of what society should do in the face of uncertainty regarding cause and effect relationships is necessarily a question of public policy, not science. Several policy analysts confronted with this problem have proposed a concept called the "precautionary principle" or the "precautionary approach" (Cameron and Abouchar, 1991 and Dethlefsen, 1993). At the center of the precautionary principle is the concept of taking anticipatory action in the absence of complete proof of harm, particularly when there is scientific uncertainty about causal links (Jackson, 1993). The precautionary principle states that decision-makers should act in advance of scientific certainty to prevent harm to humans and the environment(O'Riordan and Jordan, 1995). It addresses many of the limitations of current decision-making methods, such as type II errors, problems of cumulative effects, and limitations of science. Precautionary approaches are goal oriented, lending themselves to technology innovation, pollution prevention, and facility planning. The precautionary approach evolved as a response to the environmental and human health impacts caused by the rapid industrial growth following World War II and the weaknesses of early pollution control legislation. It is relatively new to environmental decision-making, having emerged during the early 1970s in West Germany -- "Vorsorgeprinzip" in German (Von Moltke, 1988). At the core of early conceptions of this principle was the belief that society should seek to avoid environmental damage by careful forward planning, blocking the flow of potentially harmful activities (O'Riordan and Jordan, 1995). The vorsorgeprinzip developed into a fundamental principle of German environmental law and has been invoked to justify the implementation of vigorous policies to tackle acid rain, global warming and North Sea pollution. The precautionary principle has since flourished in international statements of policy; conventions dealing with high-stakes, low scientific certainty environmental concerns; and national strategies for sustainable development (Dethlefsen, 1993, O'Riordan and Jordan, 1995). It has gained international acceptance as a guiding principle for environmental decision-making. The precautionary principle was first introduced in 1984 at the First International Conference on Protection of the North Sea. Following this conference, the principle was integrated into numerous international conventions and agreements including the Maastricht Treaty, the Barcelona Convention, and the Global Climate Change Convention. It has been implicitly incorporated into several environmental laws in the U.S., such as the Pollution Prevention Act of 1990. The U.S.-Canadian International Joint Commission has called for a phase-out of persistent organic chemicals in the Great Lakes ecosystem based on weight-of evidence criteria. The criteria state that action should be taken to prevent environmental damage when evidence from several studies taken together indicate actual or potential environmental harm. While the precautionary principle is growing in acceptance, it lacks a specific, widely recognized definition. With few exceptions, the principle remains only a concept, provides few guidelines for policy makers, and fails to constitute a rigorous analytical framework. Although several frameworks for integrating the principle into environmental decision making have been proposed (Cameron and Abouchar, 1991, Stijkel and Reijnders, 1995, and Mee, 1995), with the exception of Germany, no comprehensive, systematic structure for precautionary decision-making has been applied on a national or international level. One expert on the development of the precautionary principle has identified four questions which need to be answered in order to develop a common understanding of this concept (Gundling, 1982). These are:
Lack of a generally accepted formulation and criteria to guide its implementation has limited the wide-spread use of the precautionary principle in environmental decision-making and in some instances has led to heated debate and controversy. As such, there is a clear need to establish an institutional framework for the precautionary approach. This framework would need to introduce a common definition for the precautionary principle as well as establish a set of criteria for precautionary decision-making. Conceptually, the precautionary approach to decision-making would consist of the following elements:
A precautionary principle decision-making tool must be developed based upon this policy framework. Preliminary research into the precautionary principle has found that rather than being a quantitative tool, potentially limited by a lack of data, uncertainties, and assumptions, the precautionary decision-making protocol must establish qualitative criteria for decision-making. Thus, the protocol must consist of methodological guidelines for weighing scientific evidence and qualitative decision-making criteria that will instruct policy makers on how to proceed when dealing with limited or uncertain scientific evidence. It would consist of a two part decision tree analysis: (1) one section for decision-making based on potential hazards which already exist; and (2) a second part for decision-making regarding the introduction of new chemicals, products, and activities with potential impacts. Precaution would serve as a default decision if clear evidence of harm or safety were absent. Applying the Precautionary Principle: Decision-making to a Current Environmental Decision-making Problem Several recent environmental problems provide unique opportunities for applying the precautionary principle. These include: Endocrine disrupting chemicals and persistent organic pollutants (POPs). For example, endocrine disruption poses a serious challenge to traditional decision-making instruments as wide-ranging, often subtle, adverse effects have been linked to low-level exposures and under diverse circumstances. As dose-response for endocrine disrupting chemicals does not appear to be linear, one can assume that the traditional risk assessment paradigm will not adequately protect public health under these circumstances. This problem necessitates a new approach that can address potential impacts, with limited scientific knowledge, across environmental media and agency programs. The precautionary principle framework could be used to develop a general decision-making strategy for the introduction of, and limitations to, potential endocrine disrupting chemicals. Conclusions In recent years, government agencies have been struggling with the limitations of current environmental assessment and decision-making approaches, such as risk assessment. The limitations of these scientific approaches become even more evident in the face of new environmental challenges such as endocrine disrupting chemicals and persistent organic pollutants. Scientific knowledge regarding the potential impacts of these classes of chemicals on human health and the environment is extremely limited. Scientific proof of cause-effect relationships (and their extent) between these classes of chemicals and adverse human health outcomes may be several years or decades away and may never be established due to limitations in experimental design and the complexity of natural ecosystems. However, waiting for more evidence may be disastrous and span generations. The precautionary principle provides a new approach to weighing scientific evidence and making decisions in the face of uncertainty. As such, the precautionary principle can provide the basis of a policy framework and decision making tool to allow agency policy makers and scientists to deal with current and future environmental challenges. It will help to streamline environmental decision-making, providing a mechanism to address decision-making barriers posed by uncertainty. The precautionary principle lends itself to pollution prevention approaches and multi-stakeholder, participatory decision-making, central to the agencies' and the public health community's missions. It provides a model to advance the development of new policies and technologies designed to prevent pollution, and environmental damage, at the source. Given the complexity of current environmental health problems, the paucity of information and subsequent uncertainty about cause-effect relations, and slow pace of government testing and decision-making, the precautionary principle can provide the foundations for policies and decision-making criteria to expedite prevention-oriented public health strategies. References Cited 1) Cameron, J. and Abouchar, J. 1991. The precautionary principle: a fundamental principle of law and policy for the protection of the global environment. Boston College International and comparative law review 14: 1 27. 2) Colborn, T. and C. Clement, eds. 1992. Chemically Induced Alterations in Sexual and Functional Development: The Wildlife-Human Connection. Princeton: Princeton Scientific Publishing 3) Colborn, T., et. al. 1996. Our Stolen Future. New York: Dutton Books 4) Department of Environment of the United Kingdom. 1988. Ministerial Declaration. Second International Conference on Protection of the North Sea. London. 5) Dethlefsen, V., et al. 1993. The Precautionary Principle: Towards Anticipatory Environmental Management. In Jackson, T., ed. Clean Production Strategies. New York: Lewis Publishers. 6) Gee, D. 1995. Approaches to Scientific Uncertainty. Conference on Transport Policy and Urban Health, London School of Hygiene and Tropical Medicine, 4-7 April. 7) Gundling, L. 1990. Status in International Law of the Principle of Precautionary Action. International Journal of Estuarine and Coastal Law 5:23-30. 8) MGonigle, R.M., et. al. 1994. Taking Uncertainty Seriously: From Permissive Regulation to Preventive Design in Environmental Decision making. Osgoode Hall Law Journal 32:99-169. 9) Mee, L. 1995. Scientific Methods and the Precautionary Principle. In Freestone, D. and E. Hey eds., The Precautionary Principle and International Law. Boston: Klewer Law International. 10) O'Riordan, T. and A. Jordan. 1995. The Precautionary Principle in Contemporary Environmental Politics. Environmental Values 4:191-212. 11) Stijkel, A. and L. Reijnders 1995 Implementation of the Precautionary Principle in Standards for the Workplace. Occupational and Environmental Medicine 52:304-312. 12) U.S. Environmental Protection Agency (EPA). 1994. Health Assessment Document for 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds. Vol. II, Epidemiology/Human Data and Vol. III Risk Characterization. Washington, DC: Office of Research and Development, U.S. EPA. Document number EPA/600/BP-92/001c. 13) Von Moltke, K. 1988. The Vororgeprinzip in West German Environmental Policy. In Royal Commission on Environmental Pollution, Twelfth Report: BestPractical Environmental Option. Cmnd 310. London: HMSO. Joel Tickner Work Environment Program Univ. of MA, Lowell E-mail: ticknerj@woods.uml.edu |
| III. A Proposal For Global Research On Endocrine Disrupting Chemicals From the World Wildlife Fund | TOP |
| SEHN
Endocrine disrupting chemicals are found in living tissue around the world. The weight of existing scientific evidence from laboratory research and research on wildlife and humans provides substantial reason to be concerned about the impacts of endocrine disrupting chemicals on the "web of life", including humans and their offspring.
Governments and industry are hurrying to learn more and have begun to mobilize resources to address this global phenomenon. Within the past two years alone, assessments of the "state of the science" have been produced, or are in progress, by the Governments of Denmark, Germany, the United States and associated research organizations to mention a few. The United States and the OECD are in the earliest stages of developing screening and testing regimes for endocrine disruptors. But government and industry funds for research are limited. Moreover, industry-funded research often is greeted skeptically. What is needed now is a move from "duelling science" to "doing science". Framing the issue in global, regional and local contexts is critical, but more "assessment" and revisiting existing science is not. The challenge now is to generate new science to address outstanding questions. Addressing Research Needs A properly structured global research initiative, drawing on both public and private funds, can address crucial research gaps and build scientific consensus. A constructive partnership, where resources are pooled, appropriate oversight structures are provided, and information is shared widely, will add credibility to the results of research conducted by all parties involved. Industry, government, academia, and the public at large will be well-served by an integrated research initiative that addresses the comprehensive range of issues in a cost-effective manner. In developing options for structuring and funding a global research agenda and mechanisms for undertaking it, particular attention must be given to filling research gaps most pertinent to developing nations, and engaging scientists from these nations to address them. Endocrine Disruptors and Developing Countries Research conducted in the field of "endocrine disruption" has been conducted almost exclusively in North America and Europe--a trend which is self-evident in the scientific data available on the subject. The need for research and scientific data on endocrine disruption in developing countries is of paramount importance and significance. This need is especially acute since virtually all the chemicals so far identified as being endocrine disruptors are currently widely used and/or commonly encountered in developing countries. And, because of the exposure, the ensuing problems are likely to be more extensive and serious. A case in point is pesticides, many of which have been deemed to be endocrine disruptors. Developing countries consume an estimated 20-30% of the world's pesticides, but disproportionately account for about 50 60% of the world's pesticide poisonings and about 80-90% of the world's deaths. Further, a number of chemicals identified as endocrine disruptors have either been banned or severely restricted in developed countries, but continue to be used extensively in developing countries, often under unacceptably hazardous conditions. It would therefore be advantageous for developing countries to support the development of an integrated, comprehensive, participatory and multi-sectoral research initiative on endocrine disrupting chemicals. One Step in the Right Direction Partly in response to the World Wildlife Fund's (WWF) recent participation at the Intergovernmental Forum on Chemical Safety (IFCS) meeting in Ottawa (February 10-14, 1997), the IFCS decided that there is a need to investigate, in depth, the human, environmental and ecotoxicological aspects of endocrine disrupting substances, and recommended that the IOMC (Inter-Organization Programme for the Sound Management of chemicals), and participating organizations (OECD, UNEP, ILO, UNIDO, WHO, FAO) coordinate research efforts and take stock of the adequacy of those efforts to properly evaluate the hazards and risks of endocrine disrupting chemicals. The IFCS also recommended the establishment of an information clearing house function which will cover research program and policy responses. In addition, the IFCS "Standing Committee" (which directs the IFCS activities and plans its meetings) is to consider how to address urgent issues and new developments related to endocrine disruption and report to the next IFCS meeting on these efforts. It is clear, however, that these important steps towards global coordination are not sufficient. We urgently need to determine a process to set the research agenda, determine how to share, and fund this work. Recommendations for Next Steps World Wildlife Fund, as well as some government members of the IFCS, were calling for the initiation of an Ad Hoc Working Group on Endocrine Disrupting Chemicals. Although cost considerations prevented this call from being acted upon, WWF stresses the urgency of dealing with the threats posed by endocrine disrupting chemicals and recommends that governments should instruct their IFCS representative to take the position that an Ad Hoc Working Group be formed as soon as possible. The first task of the Working Group should be to develop options for structuring and funding a global research initiative on endocrine disrupting chemicals and the Working Group should be instructed to report back on it findings within 6 months. In reviewing options for this new global initiative, the Ad How Working Group might consider the following questions: 1) How does the research agenda get set? 2) How can this international effort build on, complement, and enhance the integrity of existing research by all sectors? 3) How will the necessary funds be mobilized and managed to assure research integrity? 4) How should research results be validated and evaluated? 5) How should the results of research be integrated, assessed and made available to the public? 6) Under what auspices - eg. existing international institution(s) or free standing public/private partners should such a multi-nation, multi sector program be conducted? 7) What lessons might be learned from other scientific assessments, e.g., for stratospheric ozone depletion and global climate change, and from other cooperative national-level efforts. WWF urges governments to participate in the IOMC process outlined above and insist that this process be open and transparent, involving all interested stakeholders. For more information contact: Rich Liroff or Barbara Rutherford World Wildlife Fund Washington D.C. |
| IV. Letters To The Editor | TOP |
| V. Announcements And News Shorts | TOP |
| SEHNShintech Corporation
Shintech Corporation plans to build the second largest polyvinyl chloride plant in the world in a mostly black neighborhood in St. James Parish, LA. Local citizens are opposed to the facility because their Parish already contains numerous petrochemical plants. Citizens have expressed their opposition to Governor Mike Foster, who has been in favor of this plant from the beginning. The Tulane Environmental Law Clinic has been supporting local citizens' groups in their opposition to the facility. Several weeks ago, Governor Foster called Tulane President Eamon Kelly noting that the clinic's work on behalf of citizens was anti-economic. President Kelly noted that he has no intention of interfering in the clinic's cases. "The nature of a university is to provide academic freedom, he said."
Digital Gallery Opens Environmental Health Dept. Digital Gallery Boston University's School of Public Health/Environmental Health Department recently launched the Internet/WEB Digital Photography Galleries I, II & III. NB This website no longer exists - Eds. Gallery II opens on May 1st, with David Wells' powerful photojournalistic images of pesticide exposed farm worker children. Wells is a photojournalist whose work has appeared in Time, Life, the New York Times, Geo, amongst other national publications. The BUSPH Gallery hosts images from Wells' series, "The Pesticide Poisoning of America". Gallery I presents a portfolio of Earl Dotter's coal mining photographs from the 1970s. Dotter's work has for its major themes occupational & environmental hazards, and child labor. Gallery III hosts work from the 1990s by Sharon Stewart. The Gallery is excerpting 18 images and text from her arresting book, Toxic Tour of Texas. "The guides on this tour are farmers, priests, mothers, ranchers, engineers, nurses, and teachers who are in on protecting their land, their children, their homes and their communities from exposure to hazardous waste." Bill Ravanesi Gallery Curator Boston University School of Public Health Science and Social Action Symposium Science and Social Action Symposium: Barry Commoner's Contribution to the Environmental Movement Friday, May 30, 1997, 9:30 A.M. - 5:00 P.M. The Great Hall At Cooper Union 7 E. Seventh Street, New York, NY (between Third and Fourth Avenues). The symposium is free and open to the public. Registration is requested by May 15. Register by phone (718-670-4180), fax (718-670-4189), or e mail cbns@chelsea.ios.com The Proceedings will be published in a special issue of the journal New Solutions, A Journal of Environmental and Occupational Health Policy. The Journal will also consider for publication in the same issue other papers relevant to the theme of science and social activism in the environmental movement. Featured speakers at this day-long event will include: Ralph Nader, Center for the Study of Responsive Law Peter Montague, Environmental Research Foundation Tony Mazzocchi, Oil, Chemical & Atomic Workers Union Virginia Brodine, Roslyn, WA Giovanni Berlinguer, University of Rome Chicco Testa, Enel, Italy Barry Commoner New Dioxin Reporting Guidelines Industry Must Report Dioxin Under Community Right To Know Law: EPA Proposal Grants Petition by Oil Refinery Network Industries across the country will be required to report releases of dioxin for the first time under federal right-to-know laws, the Environmental Protection Agency proposed today as it granted a dioxin petition filed by Communities for a Better Environment (CBE) of California on behalf of oil refinery communities. CBE coordinates the National Oil Refinery Action Network (NORAN). T Dioxin is the common name for a group of twenty-eight chemicals that are either banned or are unwanted by-products of recent manufacturing methods using chlorine. It is "one of the most, if not the most, potent reproductive/developmental toxicant known" according to EPA's response to CBE's petition. Cancer, birth defects, reproductive effects including endometriosis, slow learning, immunological effects and other serious health problems have been linked to dioxin exposure. A 1994 EPA draft health assessment concluded that dioxin levels already present in the average American's body are at or near levels which may cause some of these effects. EPA's proposal to grant CBE's petition will be published in the Federal Register soon. In it the agency proposes to add all twenty-eight chemicals with dioxin like toxicity to the list of toxics for which industries must report releases to air, water and in the Toxic Chemical Release Inventory required by the Emergency Planning and Community Right to Know Act. EPA's action responded to a petition by CBE requesting that it require petroleum refineries nationwide to report how much dioxin they release. The petition was filed on behalf of people who live near refineries in many parts of the country, after CBE and the National Oil Refinery Action Network presented new findings that refineries are a dioxin source during the Citizens Conference on Dioxin in Baton Rouge, Louisiana in March, 1996. |