Weighty issues

• May 01, 2000

Our society must find a way to optimize the integration of science with societal concerns as we shape environmental health policy. While policy should be grounded in sound science, policy decisions are always value-laden, especially where science is uncertain. Consequently, our goal must be to achieve an optimum balance between the two.

Recent trends are not encouraging. Policy makers have been marginalizing the use of science. In spite of this, we can be optimistic that scientists, lawyers and policy makers can work together to improve the process. To achieve this, however, all stakeholders — including industry, environmental advocates, regulatory agencies, the news media and the public — must be committed to the process.

Sound science the foundation

At its core, the chemical industry is committed to science and technology. Science provides society with the best means of developing reliable and usable knowledge efficiently. Because science deals only with the material realm, however, it is less helpful with problems of a moral, ethical or esthetic nature.

At the same time, chemical industry leaders expect a reasonably predictable environment in which to conduct business as well as a fair opportunity to compete. Contrary to what many believe, most business leaders do not have an irrational fear of business discontinuities caused by true environmental health concerns; these concerns are consistent with core values and often create new business opportunities. However, business leaders want such concerns to be based on reality, not on irrational fear. That is why they insist on risk-based decision-making grounded in sound science.

Earning the public trust

In the area of environment, health and safety, the public has been skeptical of the chemical industry, and understandably so. The industry made mistakes in the past and was often unwilling to engage in public dialogue. This began to change about ten years ago with the adoption of Responsible Care®, a global chemical industry program designed to earn public trust by improving environmental, health and safety performance and by engaging in a greater openness with all stakeholders.

One of the principles of Responsible Care is to develop scientific information that will advance our understanding of the potential risks associated with chemical products and operations. Although committed to generating scientific data for many years, the industry is now accelerating the development of better scientific data.

In early 1999, for example, the Chemical Manufacturers Association (CMA), the U.S. trade association that represents some 185 chemical companies responsible for more than 90 percent of the U.S. chemical volume, announced a new five-year $100 million research initiative to address fundamental questions in 10 critical areas. Member companies of the CMA will fund the research program. A similar commitment has been made by the chemical industry in other areas of the world. In the United States, 85 percent of the funding will go to the areas of exposure assessment, risk assessment, chemical carcinogenesis, endocrine disruption and respiratory toxicology. The remaining funding will be used to focus on atmospheric chemistry, ecosystem dynamics, immunotoxicity, neurotoxicity and epidemiology.

Much of this research will look at fundamental questions concerning how we assess hazards and conduct risk assessments, with the intention of reducing uncertainty. The research will be conducted in an objective and transparent manner by scientists at the Chemical Industry Institute of Toxicology, a private lab funded by dues from the chemical industry, as well as at academic and government research institutions. There will be independent reviews of all aspects of the program and results will be fully disclosed via the peer-reviewed publication process. As much as possible, the research will be coordinated with and complement existing research conducted by government agencies, universities and individual companies.

CMA member company research

Chemical companies are expected to spend more than $500 million over the next five years to fill toxicology and environmental fate data gaps on the nearly 3,000 most widely used chemicals and an additional $600 million on testing 15,000 or more chemicals to determine whether they pose a threat to the endocrine systems of humans and wildlife. This is in addition to the routine in-house safety testing that supports new and existing products.

These research programs are evidence that the chemical industry is strongly committed to generating better scientific data to reduce uncertainty about chemical safety and leading to improved public policy. Recently, however, a small but vocal group of critics has questioned the integrity of academic scientists who conduct research under industry sponsorship. This is unfortunate. As government reduces its commitment to funding research, partnerships between academia and industry are becoming ever more important. Clearly, the strongest research system requires a balance of funding sources and research institutions, including government, industry and academia.

Science in context

Scientific research does not occur in a vacuum, but in a complex social context that influences how it is understood. By nature, scientific research is full of uncertainties. It advances in tentative, incremental steps with a gradual accumulation of evidence. It often seems like a confusing contest of conflicting claims, as theories are tested by experiment and observation and new facts constantly overthrow old assumptions.

The public, however, expects certainty. A chemical substance either causes a particular health effect, or it doesn't. The concepts of uncertainty and probability are foreign and confusing and scientific illiteracy is pervasive. People are made even more suspicious by news of conflicting research findings.

This situation is further exacerbated by the general expectation that people should be able to avoid risks altogether — that they should receive the benefits of a modern society, but on a zero-risk basis. There is also a growing cynicism about large institutions — government, academic and industrial — and about science itself that leads people to assume the worst. Some people believe in a vast conspiracy that exposes them to health risks — and then covers them up. Many people prefer to believe anecdotal information, irrational novel theories or scientists who are out of the mainstream. We need to better educate the public about the fundamental concepts of science. In the meantime, society will continue to demand increased protection from perceived risk.

The public is not solely to blame for this disillusionment with science. Some scientists also contribute to the problem. In several recent cases, scientists have made bold pronouncements to the news media about unconfirmed findings. Several years ago, for example, scientists at Tulane University claimed to have found that small amounts of common pesticides, mixed together, act synergistically and may cause increased estrogen levels, resulting in breast cancer, birth defects and diminished sperm counts. Yet later — with far less fanfare — the same scientists retracted their peer-reviewed published paper when they and others could not replicate the original research findings.

Some scientists bypass publication altogether and use the Internet to communicate their findings. Although this has the advantage of disseminating research results rapidly, it eliminates the processes that double-check the results. Traditional publication in peer-reviewed journals can never guarantee that the results are correct, but it does assure that the work is important and that the methodology and reasoning are sound.

Achieving an optimum balance

Clearly, both scientific and societal concerns play legitimate roles in shaping environmental health policy. When scientific uncertainty is small, there should be little argument over policy options, but when uncertainty is large, science has less to contribute and societal concerns will play a larger role. These extremes are rare, however. Most often scientific uncertainty is moderate, leading to a search for the optimum balance between science and societal concerns. In these cases, experience has taught the chemical industry that it needs to go beyond science and factor public perception into risk management decisions.

In the face of scientific uncertainty, decision-makers frequently choose what has become known as the precautionary principle. Definitions of the precautionary principle vary, but a commonly accepted one was put forth as Principle 15 of the Rio Declaration of 1992: "Where threats exist that are serious or irreversible, the lack of full scientific certainty shall not be used for postponing cost-effective measures for preventing environmental degradation."

This approach is being demanded by the public, particularly in Europe as evidenced by the widespread outrage caused by the Bovine Spongiform Encephalopathy epidemic, or Mad Cow Disease. Application of the precautionary principle, however, is viewed by many in industry as starting down a slippery slope that could result in public policies based on theories, fear and innuendo rather than sound science.

Some people in industry, however, are coming to the conclusion that we must engage in constructive dialogue with other stakeholders to evaluate the precautionary principle thoroughly. In reality, many in industry have always taken a precautionary approach to managing chemical risks, but those who demand the precautionary principle either don't understand this or are not satisfied by this approach.

Although the Rio Declaration gave no guidelines for the practical application of the precautionary principle, the European Commission recently proposed six guidelines for policy makers to use when applying precautionary methods. They are:

• Implementation should start with an objective risk assessment, identifying the degree of scientific uncertainty at each stage;
• Once the results of the risk assessment are available, all stakeholders should be involved in the decision to study the various management options. This procedure should be as transparent as possible;
• Measures taken must be proportionate to the risk that is to be limited or eliminated;
• The measures must include a cost/benefit assessment, with an eye to reducing risk to a level acceptable to all the stakeholders;
• The measures must establish who is responsible to furnish the scientific proof needed for a full risk assessment; and
• Measures must always be of a provisional nature, pending the results of scientific research to furnish missing data, and pending performance of a more objective risk assessment.

These guidelines, while clearly in need of further refinement, serve as a start. Some of the guidelines, however, may be unworkable in practice. The fourth item, for example, will be difficult if not impossible to achieve as long as some stakeholders demand zero risk. The sixth item, too, may prove to be unworkable, since provisional changes generally become permanent when the cost of reverting back to the original is substantial.

As currently framed, these guidelines allow too much room for interpretation, especially when stakeholders with diverse agendas are at the table trying to find common agreement. This is particularly evident in the United States, where the present administration relies heavily on stakeholder decision-making panels. The result is that scientific information is not given appropriate weight in environmental policy decisions.

The marginalization of science

Recently the U.S. Environmental Protection Agency (EPA) made an interim risk management decision to replace the 300 parts per billion drinking water standard for chloroform with a zero base standard, despite strong scientific evidence showing that chloroform is a nonlinear carcinogen. A number of toxicologists, including EPA's own Science Review Board, attacked this decision as scientifically unjustified. EPA, however, appears unwilling to abandon the default assumption that there is no safe level of exposure to a carcinogen, possibly out of fear of criticism from environmental activists. If finalized, this decision will require drinking water authorities to direct resources toward managing relatively minor risks and away from controlling emerging pathogens, perhaps with grave consequences to public health.

Perhaps no other environmental health issue has been the subject of as much hyperbole as the allegation that low level exposure to chemicals disrupts the hormone system of humans and wildlife and puts the future of the human species at risk. The report that human sperm counts are falling has garnered considerable media and public interest.

The evidence for these claims is questionable. Some stakeholders believe there is enough evidence to restrict or ban certain products that were implicated in early endocrine screening and testing. The International Union of Pure and Applied Chemistry (IUPAC) and more recently the National Academy of Sciences, however, claim that the scientific uncertainties are still too great to warrant taking such action. We need to develop data that will reduce disagreement on this subject.

Much remains to be done to develop screening and testing methods that can be better standardized and validated. These approaches must be capable of dealing with both natural and synthetic substances and of placing both the beneficial and adverse effects into context. The science should develop quickly, although whether society will wait for the results is unclear. There has already been unreasoned market behavior in Japan and Korea, where polystyrene-based noodle cups have been de-selected based on misinformation about endocrine disruption, even though polystyrene has been clearly shown to be no threat.

Reason for optimism?

Despite these recent trends, there is some reason for optimism that the balance between science and societal concerns can be restored. Science usually enters the policy process through "interpreters," since bench scientists seldom become involved with policy issues. Problems arise, however, when these interpreters also become advocates.

The National Environmental Policy Institute (NEPI) identified six core issues that influence the use of scientific information during policy formation and suggested how scientists can improve communications.

Uncertainty. Spokespersons for science need to communicate to policy makers the best estimate and the span of possibilities in which some confidence may be placed.

Transparency. Policy makers must also be helped to understand how key assumptions and choice of methods affect conclusions.

Objectivity. Scientific information is most useful when presented as "policy neutral," with no suggestions as to how decision-makers should use the science.

Timeliness. Obviously, scientific information must be organized and presented to policy makers in time to affect policy decisions. Policy makers also need to know whether further research can narrow uncertainty in a timely manner.

Relevance. The information must be relevant to the decisions to be made.

Obsolescence. There must be a greater capacity to review decisions when scientific information has been significantly updated.

In light of these issues, the task ahead of the chemical industry is to ensure that risk-based decision-making is grounded in sound science, in order to bring science to the forefront as a full partner in the decision-making process. To do this, we must find ways to help scientists, lawyers and policy makers work more effectively together. Scientists must follow the scientific process and deal more effectively with those who abuse it. Scientists must also increase their understanding of the public policy process and the civil litigation system and must engage in advocating risk-based decision-making grounded in sound science. Finally, we need to implement recommendations like those of NEPI to ensure more effective integration of science in the public policy process.

E-sources

National Environmental Policy Institute Enhancing Science in the Regulatory Process — www.nepi.org/main.htm

Click here to post comments about this topic, and read what others have to say.

This article appeared in Environmental Protection magazine, May 2000, Vol 11, No. 5, p. 48.

This article originally appeared in the 05/01/2000 issue of Environmental Protection.