The Politics of Peanut Butter.

Anderson, Glen

Conflicting studies and special interest groups make developing policies to protect public health contentious and chaotic. How can lawmakers recognize 'sound' science and make good decisions?

We face health risks every day. Second-hand tobacco smoke, Car exhaust. Radon and asbestos. Pesticides in foods. High fat diets. Eating peanut butter. Not eating peanut butter.

Peanut butter? Some scientists claim that eating a peanut butter sandwich once every 10 days will give you a cancer risk of seven in a million. Others claim that eating peanuts is healthy, citing research that diets high in peanuts and peanut oils reduce the risk of heart disease by 21 percent, far outweighing a seven in a million (.0007 percent) cancer risk.

Should policymakers ban peanut butter or promote it?

How can decision makers create good policy when they are bombarded on all sides with conflicting scientific studies cited by aggressive industry and public interest groups?

Science is based primarily on facts gained from studies and technical investigations. Policy, on the other hand, tends to be value-based and incorporates the wishes of the public, industry and special interests. This does not mean that science is without controversy. As with public policy, scientists debate different theories and solutions until they arrive at a consensus.

"Policymakers often are put in the position of choosing between extreme points of view rather than making decisions based on objective and rigorous evaluation," says Ken Olden, director of the National Institute of Environmental Health Sciences.

But it is "inappropriate," he says, for groups to request more scientific research as a delaying tactic, "We have to have the courage to act when information is available that the potential risks outweigh the benefits [of not acting]."

The public may want laws that provide reasonable protection and err on the side of safety when not enough information is available. Conversely, business and industry would prefer to wait until science provides overwhelming evidence of an environmental health risk before engaging in potentially costly regulation. In the center of the fray stands the policymaker, whose task it is to balance the interests of these groups while taking into account potential economic impacts and scientific knowledge, hopefully achieving a policy that provides the best overall balance of acceptable risk, cost and health benefit.

POLITICAL SCIENCE--AN OXYMORON

"Far too many environmental health regulations are based on politics, rather than sound science," opines New Hampshire Representative Jeff MacGillivray, who holds a PhD in physics. "For example, the 1990 Clean Air Act amendments exempted heavy duty motor vehicles (SUVs) from substantial nitrogen oxide controls [pollution control] until 2004, even though it would have been a cost-effective means of reducing pollution [to include them in the controls]."

MacGillivray stresses that "environmental regulation should obtain the maximum environmental benefit for every environmental dollar spent."

Since regulatory actions can have dramatic economic effect on industry, it is essential that they be based on sound science. Regulatory action by the Environmental Protection Agency (EPA) under the Food Quality Protection Act and the Clean Air Act are burning issues because of their potential to cost the energy and agricultural industries a large amount of money.

Opponents of these new regulations purport that the rules are not based on sound science and cite studies or papers that contradict the agency's conclusions. They may demand that the government wait until more evidence is in. The problem is that legislators and the general public are mostly nonscientists and have trouble judging the quality of the scientific information that is presented.

"Policies with emotional appeal must not be allowed to displace policies that have been scientifically shown to be more cost-effective," says MacGillivray.

WHAT IS 'SOUND' SCIENCE?

So just what is sound science? "The definition of 'sound science' for someone involved in this process is usually the science that you agree with," notes Representative Phyllis Kahn from Minnesota, who holds a PhD in biophysics. Although both sides of a debate may claim their views are based on sound science while the opposition's are based on "junk science," Kahn says. "There are ways to find out for oneself whether science is good or bad."

Representative Kahn suggests that there be "good scientists who are willing to act in the public policy domain, and policy people with scientific understanding or training. First it is important that there be an acceptance among policymakers about the basic facts. From there, they can discuss policies that most effectively deal with the problem."

"Readers of any research," MacGillivray adds, "should be alert for researchers biased by their funding sources or a desire to enhance their careers, and more carefully scrutinize conclusions that may be personally beneficial to them."

Kahn gives some advice on separating the good science from the bad.

Some characteristics of sound science are:

* Comes from a credible source.

* Uses documented methodologies that produce verifiable results and conclusions.

* Carefully chooses statements of cause and effect.

* Clearly measures data reliability.

* Goes through peer review and publication. Some characteristics of questionable science are:

* Shows bias.

* Has vested interests.

* Ignores or overlooks variables.

* Uses an inadequate sample size or biased sample collection methods.

* Bases conclusions on personal or anecdotal evidence.

* Contains statements of certainty.

* Confuses correlation with cause and effect.

Science itself is a process. No one study conclusively establishes a basis for regulatory action. An initial study may indicate a connection between smoking and lung cancer, for instance, which will attract the interest of other researchers. As the process continues, discussions open up among scientists, studies are published and critiqued. Based on the amount and quality of scientific evidence, a consensus arises within the scientific community. (If an issue is relatively new and unexplored, there might not be a consensus.)

Although a consensus exists, there will surely be individuals who disagree with the majority. Poorly conducted studies and faulty conclusions are likely to exist. These are weeded out as the scientific community recognizes problems in methodology or fails to reliably achieve similar results from other studies or experiments. There is never likely to be absolute consensus among experts when it comes to any topic, but this does not mean that actions can't be taken to protect the public health.

REGULATIONS AND RISK ASSESSMENT

If there is one area of science that is most challenging to legislatures, it is determining the acceptable level of risk for health and environmental laws. Risk assessment interprets available scientific data and research, looks at possible human exposure and decides what potential harm is posed to people in the general population or to specific subgroups, such as children.

"It is highly unlikely that we will ever have all the information we would like to have prior to setting a regulation or establishing public health policy. So virtually all decisions must be made in the face of some uncertainty," says Olden. "However, it is imperative that we use all the relevant scientific information and that we also clearly articulate the uncertainty that surrounds any regulatory decision."

Much toxicity information is based on rodent testing, which is usually conducted in a manner that is not relevant to the low levels of chemical exposures and mixtures of chemicals that people are likely to encounter. Since lab rats often lack a large amount of genetic diversity, scientists may just as well be overestimating as underestimating the toxic dose for humans.

Setting health standards is a challenging task, where a delicate balance must be met between placing people at risk and creating unnecessary economic burdens. Research on lead poisoning in children, for example, suggested that too many children were being harmed by lead exposure and brought about tighter standards on lead in gas and paint.

Although it may be more accurate to determine risk from studying human exposure, the public does not want to be guinea pigs when it comes to assessing whether regulations are strong enough.

"The option of dosing humans and waiting for an outcome, as we did with lead, is no longer acceptable," says Richard Jackson, MD, director of the Centers for Disease Control and Prevention's (CDC) National Center for Environmental Health.

With respect to the current accuracy of risk assessment, he adds "Using big doses in little animals to estimate the effects of small doses in big animals [people] is inaccurate, but it's the best we have right now, and better than dosing humans."

Hoping to solve this dilemma, the CDC is currently doing research on biomonitoring.

"Biomonitoring directly measures the amount, taking away the uncertainty of prediction in risk assessment," says Jim Pirkle of CDC's National Center for Environmental Health laboratory. Analyzing blood samples to determine mercury exposure would be an example of biomonitoring.

"We at the CDC are working very hard to improve risk assessment by measuring what is actually getting into people." He adds that this new technology allows researchers "to see what people are being exposed to and how much they are being exposed. It's a major boon to risk assessment."

The problem really lies in the lack of research about the toxicity of the thousands of chemicals we are exposed to, how these mixtures of chemicals affect humans at the low levels to which they are exposed and how much humans are really absorbing into their bodies.

Olden thinks although the Clean Air and Food Quality Protection acts are appropriately strong, "regulatory agencies are in the unfortunate situation of not having an adequate scientific foundation. We just have to develop the science base to allow the legislation to have the impact that Congress intended. We also need to identify key gaps in knowledge and stimulate research to address areas so that more informed decisions can be made in the future."

MacGiilivray notes, "Sound science requires that benefits and costs be calculated based on the best information available, and that research continues to ensure that these policies stay up-to-date."

ACCEPTABLE RISK

The controversy surrounding the Food Quality Protection Act epitomizes the problem-filled interaction between science, politics and who determines acceptable risk.

Enacted by Congress in 1996, the act among other things requires the EPA to review the use of pesticides and ensure that children are adequately protected. From there, the debate breaks down into the safety of the food supply vs. the cost of compliance.

Stressing the importance of implementing "the first health-based standard for regulating pesticides," Routt Reigart, MD, chairman of the advisory board of directors for the Children's Environmental Health Network, said the law ensures that a pesticide is not considered safe for use until there is "reasonable certainty of no harm."

That approach appeals to the public health community because it puts the burden on pesticide manufacturers to prove that their products are safe, rather than requiring government to prove that they are unsafe. "The aim is to eliminate older more toxic pesticides and replace them with newer, safer pest prevention chemicals and technologies that are just as effective," adds Jackson.

Within the food industry, apprehension about the scientific basis for standards developed under the Food Quality Protection Act is reflected by resolutions that Georgia, Kansas, Michigan, Missouri, Pennsylvania and Wyoming passed in 1998 and 1999. These state resolutions urge the EPA to use sound science, make no decisions unless adequate data are available and avoid actions that will have an adverse economic impact when considering new pesticide tolerances.

Senator George McManus of Michigan, a fourth generation cherry farmer who sponsored the resolution in his state, says "We are asking that EPA base regulations on science rather than politics when setting pesticide tolerances. The agricultural industry relies heavily on pesticides, and it is expensive to develop new ones.

Also, alternatives are not available for some pesticides to control certain pests," he notes. "It's a matter of determining how safe is safe."

So ... is it safe to eat peanut butter?

"We all have a 250,000 in a million [a one in four] risk of dying from cancer," says the CDC's Jackson. "Every decision one makes is a balancing of risks based on individual perception. Even though a seven in a million increase in cancer risk is very small, I'd rather eat peanut butter from brands that use peanuts that are low in cancer-causing toxins."

Glen Anderson specializes in environmental health science for NCSL.

THE IMPACT OF GENETICS

In the future, genetics will provide a basis for sound science and may lessen the debate over health-based environmental regulations. In the coming years, genetic research will help us regulate the number of with improved accuracy and better identify susceptible people who benefit from regulatory action.

To this end, the National Institute of Environmental Health Sciences is working on the Environmental Genome Project (not connected with the Human Genome Project), which is aimed at identifying genes that determine susceptibility to environmental diseases. Although current research is based on the average person, genetics tells us there is no "average" person. Gene identification and subsequent research will help tailor policies that protect sensitive individuals at potentially lower regulatory costs.

"Regulations are based on homogeneous populations and do not take susceptibility into account," says William Suk, deputy director of the Environmental Genome Project "This is fine for the general population, but not for the susceptible individual who suffers."

It is difficult to know, given the tremendous uncertainties related to developing standards, whether we are under or overregulating and whether we are adequately protecting public health. "More information about genetic susceptibility would make risk assessment more accurate and, individualized: The goal is to get the sound science necessary to make good regulations"' says Suk.