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Science in policy making
by Marcia Ishii-Eiteman, Margaret Reeves, Medha Chandra, Emily Adams
Science can and should play an important role in formation of public policy. Scientific practice that adheres to widely accepted conventions of hypothesis testing and rigorous independent peer-review can provide society with very useful information to guide its policy-making and regulatory processes. Unfortunately, however, scientific tools are often misused to suit political and economic ends. This problem has long plagued pesticide regulation in the United States.
What’s Wrong with Risk Assessment?
Risk assessment is the method used by the EPA to determine the relative risks of exposure of humans to pesticides or other products. The Agency combines the information from risk assessments with other data to form its regulatory decisions.
Since there is stronger ethical opposition to testing chemicals on humans for risk assessments than on animals, the EPA generally tests animals. Data from animal tests are extrapolated to humans and are then used to determine an “acceptable” level of human exposure and risk to the chemical being assessed, typically adding a margin of safety. The levels of chemical exposure allowed to humans are usually displeasing to the chemical industry, which is often asked to conduct its own risk assessments—a blatant violation of the democratic process of practicing independent, peer-reviewed science conducted on behalf of public health and the public interest.
Industry-sponsored or not, the entire risk assessment process is seriously flawed. The questions proponents of risk assessment ask with respect to chemicals are: How much damage will this cause? To what degree will humans and non-humans be exposed? Will the consequences be acceptable? However, “acceptable” is a highly relative, value-laden term, with political and economic power, biases, and ethical judgments attached to it. In practice, risk assessment has become a tool not to reduce risk, but to maintain the status quo.*
Instead the questions that we need to ask are: Is the use of this product really necessary, effective, and/or ethical? How little damage is possible? Have researchers ignored important health effects that can occur, for example, from sub-acute exposures, such as damage to neurological, hormonal and reproductive systems? What are the associated health costs to individuals and the public resulting from the use of this product? Are there less hazardous alternatives? Are the assumptions underlying risk assessment valid? Can we really assume, for example, that under real world conditions, pesticide applicators consistently follow the instructions of use written on product labels?
With informed public debate, these are the kinds of questions that would be asked and that we would expect scientists accountable to the public to answer. It is these questions that career scientists we know who work for the EPA want to be free to ask. In turn, the answers—derived from independent, rigorous, peer-reviewed research—should inform our regulatory decision-making process in a fully transparent manner. Yet in too many cases EPA has been structured so as to make asking the questions impossible, a problem exacerbated by consistently being forced to seek advice on questions to be addressed from advisory panels, which contain too many representatives of regulated industries.
The appropriate role for the chemical industry is to pay for independent scientific endeavours; overseen by public institutions that are insulated from political manipulations to assure there is no industry influence and associated conflict of interest. Specifically, pesticide manufacturers, formulators, distributors, retailers, or other industry representatives should have no role in the design or implementation of research designed to determine the relative effectiveness and risks associated with the use of their products. Until such reforms are implemented, EPA-style risk assessment cannot be trusted.
* Mary O’Brian, Making Better Environmental Decisions: An Alternative to Risk Assessment, MIT Press, Cambridge, MA, 2000.
Conflict over the safety of pesticides has been going on since they were introduced on a grand scale in the 1940s. Promoters of chemically-reliant pest management and industrialized agriculture, as well as those who prize public and environmental health and food security over corporate profit, frequently bolster their arguments with reference to “the science.” Different analyses of the same chemicals are then presented to support contradictory conclusions by scientists on opposite sides of this debate. But isn’t science supposed to be “factual,” objective and bias-free?
Science is commonly understood to be the exploration of phenomena through a process that generally includes the observation and identification of a problem, and formation of a question (or hypothesis) that can be repeatedly tested to confirm or refute the hypothesis. When different scientists test a hypothesis independently and reach similar results it develops a common understanding of the phenomenon, which is held to be true until or unless other scientific testing disproves it. A key difference between science and belief or ideology is that a scientific theory—such as the theory of evolution by natural selection—is open to being disproved; but a belief—like that of creationism—can neither be proved nor disproved.
It is important to add that science is a deeply social process—research is shaped by who asks the questions that are being explored, what questions they choose to ask, and towards what ends. The ability to conduct scientific research is not readily available to all, and use of its results to inform important decisions in society is highly political.
The fate of the University of California Berkeley’s world-renowned Division of Biological Control is a case in point. For decades this department conducted stellar research on non-chemical methods of agricultural pest management. But in the late 1980s, as the University pushed to establish its pre-eminence in biotechnology, Biological Control was drastically downsized. In the late 1990s, the university secured $25 million over five years in research support from the Switzerland-based agricultural and biotechnology firm Novartis (today part of Syngenta), making it a major funder of the university’s Department of Plant Molecular Biology. As part of the deal, the company secured extensive patenting rights as well as considerable influence over the Department of Plant Molecular Biology’s research decisions. At the end of the five years, Novartis did not renew the agreement and no major patentable results accrued. Meanwhile, in the absence of equivalent financial and high-level political support from university administrators, research leading to sustainable, ecologically-based solutions to pest problems in agriculture had been further crippled.
Despite the many ways in which social, economic and political forces shape scientific practice, its findings are still generally accepted as objective truth. This awe and almost blind belief in science has been exploited by industry and pro-industry politicians in their attacks on proposals for stronger environmental regulations. Politicians averse to taking steps to protect human health or the environment typically defend their inaction by citing a need for more scientific research to “get all the facts” before any pro-environmental regulation can be enacted.
In U.S. pesticide regulation, most of the scientific research is, ironically, conducted by the very industry the government is supposed to regulate. But relying on one group’s presentation of “the facts”—without context or critical appraisal of who conducted the research, whether the right questions were asked to begin with, and whether results were presented selectively or not—can and does lead to very badly informed policy decisions. The reason is clear: those with an economic stake in the policy outcomes have been allowed to ask the questions, conduct the research, and provide the answers regarding what is safe or what are acceptable risks to public health or the environment.
When examining the way science is used in policy-making in the U.S., it becomes apparent that the politically-appointed heads of government agencies often select the “science” that is to be considered, in order to achieve desirable political outcomes. For example, the Bush administration and others before it have frequently ignored compelling scientific evidence when it doesn’t fit their needs. This approach delayed and diluted action on ozone depletion and global warming, to name only two astounding examples. It continues to be used to fend off long-overdue action on pesticides and other pollutants.
On the other hand, scientific analyses presented by public interest groups is all too often labelled “junk science” whenever evidence of harm presented by such groups threatens to lead to greater regulation of polluting industry’s processes or products. This disparagement of public interest group science is rarely about the rigor of the evidence presented or analysis undertaken—but mostly about who is presenting the science. Such tactics of attacking the messenger are standard practice in politics, and serve mainly to delay policy and regulatory decisions that would otherwise cut into the profits of the polluting industry.
The principal analytical tool used by the U.S. Environmental Protection Agency (EPA) in regulating pesticides is risk assessment. However, in using this tool, EPA frequently asks the wrong questions in the wrong way, and then spends years answering (or not answering) these questions. This plays into industry’s delaying tactics by demanding that more scientific data be produced before any regulatory action is taken (see What’s Wrong with Risk Assessment? on page 19). The more the government delays in taking regulatory action, the more industry profits from its under-regulated toxic products. Meanwhile, strong, peer-reviewed scientific evidence of harm to human health and the environment from pesticides is buried in an avalanche of often-spurious industry-sponsored studies designed to muddy the waters.
The delays allowed and generated by the EPA around the regulation of the pesticide atrazine, despite the availability of compelling scientific evidence of its harms, illustrate the flaws of our risk assessment process (see excerpt from “It’s Not Easy Being Green” by William Souder). The example illustrates how the EPA and industry engage in what Stephen Fineman calls a “collaborative style of regulation” that lends itself to “willing collusion, even mutual capture.” 1 This collusion can lead to reprisals against other scientists, as when a political administration intervenes and represses the scientific findings of its own public scientists in order to protect the interests of the industry (see “Attack on FDA and EPA Scientific Integrity” by Brian R. Hill).
It is important to remember that science is a social act, and its results can never be accepted as purely objective. Findings from any study reflect the social, political and financial conditions under which the science took place, and are especially influenced by who framed the questions. Hence, policymakers should not base their decisions on scientific findings produced by industry with vested interest in the outcome, unless corroborated by independent analyses produced through the peer-review process. Public perspectives and concerns should also inform the scientific research process and its uses to ensure that regulatory policy takes prompt action based on the evidence at hand, to prevent harm and protect the public good.
The EPA’s use of science to inform policy can and does produce results good for human health and the environment; but it does so at a glacial pace and seldom thoroughly, registering new chemicals faster than it deregisters the worst of the old pesticides. Two illustrations are its recent decision to ban essentially all home uses of the neurotoxic pesticide chlorpyrifos2 and all agricultural uses of the highly toxic and environmentally persistent organochlorine pesticide lindane (see Ban Lindane NOW! article by Kristin Schafer). These decisions were based on EPA’s review of compelling scientific and medical evidence.
Yet the delay of action was criminal. The EPA called lindane “one of the most toxic, persistent, bioaccumulative pesticides ever registered” on August 2, 2006, the day it’s de-registration was announced—twenty-nine years after its review began! Shockingly, powerful industry interests have successfully argued for the continued pharmaceutical use of lindane on children for treating lice and scabies and the widespread use of chlorpyrifos in agriculture—where rural children and adults continue to be exposed. It is beyond comprehension that anyone can honestly claim, at this point, that “more research” is needed to eliminate all of these uses.
Politically and financially motivated misuse of science is an important reason for changing the balance of power among stakeholders in our current policy and regulatory processes. Public concerns need to inform the design of scientific research questions from the start. Scientists asking policy-relevant questions should be free from political pressure and conflicts of interest, and an informed public should debate the issues and provide direction to elected representatives in establishing socially desired and culturally appropriate policy. All these are essential to the formation of sound policy in a democratic society.
Good policy formation depends on preventing government-industry collusion, breaking free of the paralysis of inaction, and acting to protect the public and the environment. In doing so, all available evidence must be considered, and precaution—the internationally recognized principle of taking preventive action when the health of humans or the environment is at stake, to protect ourselves and our planet from harm—must be applied in making policy.
Drs. Marcia Ishii-Eiteman and Margaret Reeves are Senior Scientists at PAN. Marcia coordinates our Sustainable Alternatives Program and is a lead author for the UN’s International Agricultural Assessment. Margaret coordinates our Organophosphates Campaign. Dr. Medha Chandra is PAN’s editor and supports PAN International’s Working Group on Pesticides and Corporations. PAN research associate Emily Adams is studying environmental science, policy and management at UC Berkeley.
References
1. Fineman S. 1997–1999. Negotiating the Environment—the Regulator and the Regulated. University of Bath, UK. Available at www.sussex.ac.uk/Units/gec/ph4summ/fineman.htm.
2. U.S. Environmental Protection Agency. June 2000. Chlorpyrifos Revised Risk Agreement and Agreement With Registrants. Available at www.epa.gov/pesticides/op/chlorpyrifos/agreement.pdf.