Expert Testimony versus Junk Science
On March 30, the United States Supreme Court heard arguments in a case that may determine what standards should apply to the scientific evidence on which expert testimony is based. In Daubert v. Merrell Dow Pharmaceuticals, parents of children born with structural birth defects alleged that the defects were caused by Bendectin, an antinausea drug given to the mothers during pregnancy. Arguments on each side centered around the admissibility of expert testimony concerning the scientific evidence linking Bendectin to limb deformities.
A federal trial court in California refused to admit the scientific testimony provided by experts for the children's families, declaring that the opinions of the experts were based on animal studies suggesting that the chemical structure of the drug is similar to other known chemical teratogens and reanalyses of the data from studies on human cells. The court considered these techniques experimental and held that they did not meet the 1923 appellate court standard permitting only expert testimony based on scientific methods generally accepted by members of the scientific community (i.e., methods that had been published in peer-reviewed scientific journals).
The district court ruled for Merrell Dow, and the U.S. Court of Appeals for the Ninth Circuit affirmed, holding that the evidence from animal studies was insufficient and that the human cell study "reanalyses" had "neither been published nor subjected to the rigors of peer review. Although the qualifications of these experts were never disputed, their opinions were not allowed because they were inconsistent with the conclusions of studies that had been peer reviewed and published.
The United States Supreme Court must now rule on whether, as the attorneys for the children's families contend, the 1923 standard has been superseded by the Federal Rules of Evidence, established by Congress in 1975, which state that all relevant evidence should be admitted. The attorneys for the children's families are arguing for the more lenient standard of the federal rules which would allow the testimony and leave it to the jury to decide on its credibility. Attorneys for Merrell Dow counter that what some call "junk science" including experimental techniques and testimony from scientific "hired guns" tends only to mislead or confuse the fact-finding process and should not be admitted.
The case has great implications for environmental and toxic tort litigation and is being closely monitored by scientists, environmental and consumer advocacy groups, industry, and attorneys in environmental law. More than 20 groups have filed "friend of the court" briefs expressing support for both sides of the issue. The Na-tional Academy of Sciences and the American Association for the Advancement of Science have joined the Chemical Manufacturers Association and the National Association of Manufacturers in petitioning the Supreme Court to allow only peer-reviewed scientific evidence in personal damages cases. The American Trial Law-yers Association, the National Resources Defense Council, several highly respected epidemiologists, and state governments have filed briefs with the Court arguing that expert opinions must be admitted in these cases. The Court is expected to rule on the case by the close of summer session.
The Green Sink
|
Down the drain. Are plant "sinks" backing up? |
In the United States alone, demand for re-sources and their use in manufacturing consumes nearly 178 billion kilograms of synthetic organic compounds annually, including over more than 318 million kilograms of pesticides. If you've ever wondered what happens to these compounds after use, you're not alone. Although some scientists have long believed that terrestrial and aquatic plants act as a sort of "green sink," taking in chemicals and rendering them harmless to humans and the environment, some are beginning to question whether the sink may eventually back up.
According to Michael Plewa, a scientist at the Institute for Environmental Studies at the University of Illinois at Urbana-Champaign, the energy flow of the biosphere begins with plants, which make up more than 90% of the total biomass of the earth. In addition to providing the earth's more than 5 billion people with oxygen and food, plants perform the vital function of absorbing xenobiotics, including certain pesticide residues, and metabolizing them into insoluble or "bound" fractions of plant cells, most of which is incorporated into lignin, a natural polymer of plant cell walls. Incorporation reduces the bioavailability (e.g., amount that may be taken up by an animal that eats the plant) of the products of this metabolism.
Until recently, says Plewa, the literature in this area has suggested that bound residues exhibit little bioavailability when consumed by animals, so the "traditional idea is don't worry about them; it can't hurt you." However, recent studies dem-onstrated that scientists may be severely underestimating the bioavailability of these residues, with implications for risk assessment.
Studies published in the Journal of Agricultural and Food Chemistry showed 66% of chloroaniline (a model xenobiotic)-lignin metabolites were released as simple chloroaniline derivatives after passage through the rat gastrointestinal tract, and 11-20% of bound residues was released from 3,4-dichloroaniline-lignin isolated from wheat plants that were fed to rats and lambs. According to Plewa, these studies indicate that "the toxicity [of the metabolite] could be released. It isn't just tied up and disappears." There appears to be a wide range in the bioavailability of xenobiotics bound to insoluble plant fractions.
This range in bioavailability raises questions that may have great impact in the future for environmental toxicology. Plewa says that plants are being bombarded with materials. What isn't known is the capacity of plants to serve as a sink. Is it possible to saturate this sink so that plants cannot further absorb and metabolize chemicals to stable, insoluble forms, and if so, will plants then release what they can't absorb, damaging the biosphere? In addition, Plewa states that if current risk assessments are based on the amount of residue that is not bound, then a change in that estimate could have a radical effect: "You don't need to alter too much of the equation before it shifts the risk assessment."
Healthy People 2000
The U.S. Public Health Service's success in establishing disease prevention and health promotion objectives for the nation should provide a base for President Clinton's health care reform program. Prevention of disease and promotion of healthful behaviors are cornerstones of the health care reform package, which will likely include environmental health among its priorities.
In September 1990, PHS issued Heal-thy People 2000: National Health Pro-motion and Disease Prevention Objectives. The document sets specific goals for health promotion, disease prevention, and health protection in 21 critical areas. It also calls for the creation of data and surveillance systems to track progress toward the goals. An ad hoc working group chaired by staff from NIEHS and CDC established 16 environmental health objectives. Experts from academia, local, state, and federal regulatory and health agencies and health care providers served on the working group.
The environmental health ob-jectives set ambitious targets for reducing environmentally related diseases and conditions such as asthma, mental retardation, waterborne diseases, and lead poisoning. Other goals include reducing pollution of indoor and ambient air, improving drinking and surface water supplies, and cleaning up hazardous wastes sites. Pollution prevention goals address solid waste air toxics and community-based recycling. The working group also sets goals for state and local programs for residential testing for lead paint and radon and developing construction standards for new homes to prevent accumulation of radon gas.
NIEHS and CDC have been assigned the tasks of developing strategies to attain the environmental health objectives and of tracking progress toward the goals. How-ever, the implementation of the programs to achieve the objectives is shared by federal, state, and local agencies, health care providers, voluntary and professional organizations, community groups, and individual citizens. A steering committee with representatives from these groups has been created to assist NIEHS and CDC in this national effort. Progress is already being made toward many of the goals. An exception is protection of drinking water and surface water: water quality has worsened in many locations during the two years since the objectives were set. The recent outbreak of waterborne disease in Mil-waukee, Wisconsin, lends credence to the importance of these objectives to public health.
Voices in the Wilderness
Severe poverty, death threats, and imprisonment are just some of the obstacles overcome by this year's winners of the Gold-man Environmental Prize, the largest international award program for grassroots environmentalists.
The Goldman Prize, awarded for "sustained and important efforts to preserve or enhance the environment," includes a $60,000 award to allow the recipients to pursue their visions of a renewed and protected environment without financial constraints. The prize jury includes members of the Goldman Environmental Foun-dation and individuals such as Secretary of Interior Bruce Babbit and Joan Martin-Brown, director of the Washington, DC, office of the United Nations Environment Programme. A network of 19 internationally known environmental organizations including the Sierra Club, National Au-dubon Society, National Geographic Society, Environmental Defense Fund, Natural Resources Defense Council, and a confidential panel of environmental ex-perts from more than 30 nations nominates the winners, one from each of the six inhabited continents.
Asia: Dai Qing. The daughter of a revolutionary martyr, Qing, a former missile technician and one-time intelligence agent, is now a journalist in Beijing. Qing has openly and ardently opposed China's Three Gorges dam. The project, scheduled for China's Yangtze River, would force the resettlement of 1.2 million people, drown more than 100 sites of archaeological importance, and submerge a stretch of canyons known as Three Gorges. Taking great personal risk, Qing inspired dam opposition by compiling and publishing Yangtze! Yangtze! a collection of essays by prominent Chinese scholars critical of the dam. As a result, the project was shelved, at least temporarily.
Europe: Sviatoslav Igorevich Zabelin. In response to concern about the severe environmental problems facing the predemocratic Soviet Union, Zabelin co-founded the Socio-Ecological Union (SEU), a coalition of 250 grassroots environmental organizations working in 11 of the 15 former republics. Since 1991 Zabelin has been the chief assistant to Alexei Yablokov, advisor to Boris Yeltsin on ecology and health, working to draft environmental legislation to prevent exploitation of Russia's natural resources as the nation opens its borders to corporations from around the world.
|
Challenges. Lakota Indian JoAnn Tall has risen to the environmental challenges of Native Americans. |
North America: JoAnn Tall. Though suffering from debilitating rheumatoid arthritis, Tall has spent years working from the Pine Ridge Reservation in South Dakota to organize Native Ameri-can people to prevent environmental abuses by corporations and governments on tribal lands. Tall co-founded the Native Resource Coalition in 1989 to educate indigenous communities about environmental threats. Some of her successful efforts include stopping nuclear weapons testing in the Black Hills and preventing location of a hazardous waste site on the Pine Ridge and Rosebud Reservations.
Africa: Garth Owen-Smith and Margaret Jacobsohn. Working from a remote area of newly independent Namibia known as "World's End," Smith and Jacobsohn have devised and implemented a unique two-way conservation system to combat poaching of black rhino and desert elephant populations using unarmed local herdsmen as guards. In contrast to the increasingly militarized response to poaching in other areas, the peaceful "community-based conservation development" plan is considered a model for African communities and has resulted in an increase in wildlife populations.
|
Sitting down at the table. Mayr brings Colombia's Kogis into an environmental alliance. |
South/Central America: Juan Mayr. Despite working under volatile and dangerous conditions, including death threats, Mayr, a photographer turned journalist, has been successful in forging an environmental alliance between Colombian guerillas, peasants, and the Kogi, a pre-Colombian community. The Fundacion Pro Sierra de Santa Marta works to protect the world's highest coastal mountain (18,947 feet above sea level) and its mi-crocosm of biological diversity in which arctic, tundra, rainforest, and desert environments are imperiled.
Australia/Oceania: John Sinclair. For 20 years, Sinclair has helped define public interest law in Australia by challenging the government on environmental protection, particularly in regard to Fraser Island, the world's largest sand island, located off the coast of Queensland. Sinclair has succeeded in halting the environmentally damaging practices on the island of sand mining and logging the island's rainforest and in the process has raised public awareness of the island's importance. To date most of the island has been declared a national park, and in 1992 it was designated a World Heritage Site.
Dioxin and Ecological Risk Assessment
An interim report issued by EPA on April 23 states that residues of dioxin in fish from Lake Ontario have decreased over the past decade. Lake Ontario has contained the highest levels of dioxins of all the Great Lakes, but according to Phil Cook of the EPA in Duluth, Minnesota, the trend is the same for all the Great Lakes and most aquatic environments in general. "Lake Superior [dioxin] levels were not detectable in many fish . . . the levels were in the part per trillion range," said Cook. Cook added that dioxin levels in fish depend on factors such as the age and fattiness of the fish, for example, and that the decreasing trend may not be true for all aquatic environments, but that "the trend has definitely been down." The interim report, which evaluates the data on dioxin and the aquatic environment and associated wildlife, is the first step in a long-term program to reassess the ecological risks of dioxin.
Evaluating the risks of dioxin to the environment is one part of EPA's reassessment program. A health risk characterization, resulting from a reevaluation of data on human health and exposure, will be submitted to EPA later this year.
The interim aquatics report focuses on the bioaccumulation of dioxin in the aquatic environment and discusses issues related to risk characterization. Specific findings of the report are:
- For aquatic organisms, the reproductive system is the most sensitive to the effects of dioxin, resulting in early mortality, especially in fish.
- Of nonaquatic wildlife, fish-eating mammals and birds are the most susceptible to the effects of dioxins, but data on these dietary relationships are limited.
- Significant uncertainties remain concerning levels of dioxin in aquatic environments because exposures occur through water, sediment, and diet.
EPA will sponsor an expert panel workshop later this year which will evaluate the data and methods in the interim aquatics report for use in ecological risk assessment. A final report from this workshop, incorporating research now in progress, will be published in 1995.
EPA recently used concepts similar to those in the interim aquatics report to formulate criteria for dioxin under the Great Lakes Initiative. The period for public comment on the Great Lakes Initiative proposal closes in mid-September.
Pollution Auction
For sale: Acid rain. Cheap. Contact EPA. The EPA didn't actually advertise its first-ever auction of pollution allowances in this way. Nevertheless, more than 150 bids were made on March 29, amounting to over $21 million, at the Chicago Board of Trade's auction of the rights to emit sulfur dioxide, the main component of acid rain.
The CBOT held the auction on behalf of the EPA, which is responsible for administering a national market-based program to curb sulfur dioxide emissions. Utilities, brokerage firms, and even environmentalists purchased the rights, which sold for $122 to $450 a ton, to emit 150,010 tons of sulfur dioxide. Industry, environmentalists, and EPA are calling the program an initial success.
The auction was part of a program established under the Clean Air Act Amendments to force power companies to cut sulfur dioxide emissions in half by the year 2000. The program allots pollution allowances to utilities: each allotment allows discharge of one ton of sulfur dioxide a year. Companies may use their allotments to comply with the Clean Air Act standards, or, if they clean up their operations, they can sell their excess allowances. The initial allowances sold at auction had been taken from the utilities by the EPA and were set aside to be sold. EPA will distribute the profits from the auction among the power companies who contributed.
The CBOT has announced plans to hold its own quarterly auctions of pollution rights, which, although not specifically authorized by EPA, are said to be approved of by the agency. Although auction analysts interpret the program's success as a sign of the need for such a market, the development of a market for pollution allowances may well encounter some obstacles. In New York, efforts to restrict allowance trading to minimize acid rain in the Adirondacks prompted the New York General Assembly to approve a bill that would allow the state to restrict pollution trading. It is also unclear how state utility regulatory commissions will be involved in emissions trading. In addition, some sources worry that characterization of the program as "buying the right to pollute" may discourage industry from purchasing allowances out of concern for their public image. Overall, however, the program is expected to reduce the cost of complying with sulfur dioxide emission standards--a savings that could ultimately be passed on to the consumer.
Risk Panel Completed
With the appointment of the two final members of the Risk Assessment and Management Commission, the panel should soon be ready to tackle the task it was given more than two years ago in the 1990 amendments to the Clean Air Act.
Senate Majority Leader George Mitchell (D-Maine) named Norman Anderson, director of Environmental Health for the American Lung Association of Maine, and David P. Rall, former director of the National Institute of Environ-mental Health Sciences, to the panel which was established under section 303 of the 1990 amendments to study the risk assessment process and advise the government on its use in environmental management.
Mitchell's action comes as the Clinton administration decides whether to replace the Bush appointees to the commission. Some sources have been critical of the Bush appointees for being too conservative, particularly Thorne Auchter, former head of the Occupational Health and Safety Administration. Though the president has the authority to replace the Bush appointees as they "serve at the pleasure of the president" and nothing in the Clean Air Act amendments prevents it, many hope that the new appointees will provide enough balance so that the Clinton administration will not find it necessary to alter the panel, causing further delay.
Rall has a reputation for being well informed and knowledgeable on risk assessment issues and has been influential in setting national environmental health policy. Anderson is well respected and is expected to bring the environmentalist viewpoint to the panel discussions.
Industry Waste Exchange
National
Materials
Exchange
Network
U.S.
1-800-858-6625
Canada
1-509-325-1724
Direct user assistance
1-509-325-0507 |
The Pacific Materials Exchange (PME) is fast proving that one industry's trash may be another's recycled treasure. EPA has extended the grant of this nonprofit corporation to develop and implement a national computerized industrial waste exchange network to encourage pollution prevention.
The National Materials Exchange Network (NMEN), an information clearinghouse that allows companies to publicize information about their waste streams to encourage reuse, electronically links virtually every industrial waste exchange in North America. The grant extension, announced by House Speaker Thomas Foley (D-Washington), will allow PME to continue to build its network and encourage industry to use it. "Using technology to promote and encourage industrial recycling is a practical, cost-effective approach to help protect the environment," says Foley. "We all benefit."
Sponsors of the NMEN say that up to now, waste exchanges have relied on printed materials to communicate information about waste streams. The NMEN allows subscribers to use a computer 24 hours-a-day to access information on materials located across town or across the country. Access to the network is free with participation in an affiliated waste exchange. The network lists materials available and materials needed, such as waste by-product, off-specification, overstock, obsolete, and damaged materials; used and virgin materials; and solid and hazardous wastes.
It is estimated that industry currently saves $27 million and the energy equivalent of 100,000 barrels of oil annually by using waste exchange. According to Robert Smee, director of PME, this is only a small portion of the potential savings. There are currently about 5000 materials listed, representing roughly 11 million tons annually. EPA estimates that industry alone generates 7.6 billion tons of solid waste alone each year.
Last Update: September 11, 1998