Environmental Progress

In the past decade or so, many businesses have evolved in their outlook on protecting human health and the environment. Increasingly, many parts of industry--including chemical manufacturing firms--are establishing systems to anticipate and prevent environmental and health problems and are voluntarily producing hazard data for some of their products.

An Oct. 13–14 workshop, sponsored by the Institute of Medicine's Roundtable on Environmental Health Sciences, Research & Medicine, probed the status and future direction of voluntary corporate programs and how they relate to government regulation. The workshop examined voluntary programs such as corporate environmental management systems and industry codes like the American Chemistry Council's (ACC) Responsible Care program.

The wide-ranging discussion also examined the U.S. chemical manufacturers' voluntary efforts, coordinated with the Environmental Protection Agency and an environmental group, to test the safety of substances they manufacture in the greatest amounts. In addition, participants discussed the European Union's pending legislation on the registration, evaluation, and authorization of chemicals (REACH, see page 28) and precautionary approaches to regulating pollution.

In recent years, many businesses have adopted environmental management systems. The workshop began by examining these systems, which are designed to help ensure compliance with mandated environmental standards and to cut waste.

Environmental management systems incorporate environmental considerations into the day-to-day operations throughout an organization, explained Edwin Piñero, the White House's federal environmental executive. These systems are aimed at promoting continual improvement in environmental performance, he said. They work by correcting root causes of environmental problems, not merely identifying and mitigating an immediate issue.

For example, Piñero said, if an organization, whether a government agency or a company, discovers an unlabeled drum of hazardous waste, its environmental management system would ensure that the container would get properly labeled. In addition, the management system would also determine why the drum had not been labeled, which might include reasons such as a simple error by an employee or the lack of worker training on proper handling of hazardous waste.

Deanna H. Matthews, a research associate in civil and environmental engineering at Carnegie Mellon University, has studied environmental management systems in depth. She told the workshop that these systems are typically focused on ensuring that a company adheres to environmental regulatory requirements.

But her research has found that businesses with environmental management systems have compliance records that are nearly the same as companies without these systems. Companies with environmental management systems, for instance, do not differ significantly from firms without them in toxic releases, major air pollutants, or generation of hazardous waste, Matthews said.

THIS MEANS that organizations with environmental management systems in place are likely to have a limited potential to go "beyond compliance" and perform with less pollution than allowed by regulatory standards, she noted.

Matthews suggested that environmental management systems should be designed to flag potential environmental and health problems, especially the creation and release of currently unregulated chemicals that bioaccumulate. An effective environmental management system also should include charting the materials and energy inputs and outputs of a company's operations. By doing so, a company can identify specific substances in its outputs that could become problematic, she said.

Environmental management systems can fit into voluntary corporate strategies for limiting a business' emissions of carbon dioxide or managing the amount of water and energy it uses, Matthews added.

Cary Coglianese, associate professor of public policy at Harvard University's Kennedy School of Government, said other research has shown that facilities with environmental management systems do make improvements to their environmental performance, including more efficient use of energy. However, these gains are realized in the short term, and continuous improvements are not realized, he said.

Even though some research suggests that environmental management systems can make a difference, no one has determined whether having these systems provides a greater benefit than other policies, including prescriptive pollution control regulations, Coglianese said.

Richard P. Wells, president of the consulting firm the Lexington Group, told the workshop that environmental management systems need to penetrate into corporate research and development departments. This permeation would impact the design of products and processes, and thus lead to continuous improvements in environmental performance, he said.

Reducing use of hazardous solvents could save money in the R&D departments in many pharmaceutical firms, said Berkeley W. Cue Jr., a consultant with several technology companies that serve the pharmaceutical industry. Cue told the workshop that R&D operations at many drug companies spend more to dispose of certain solvents, which are classified as hazardous waste once they are used, than to purchase those solvents in the first place.

Cue advocated that pharmaceutical companies move from fossil-fuel-based chemical synthesis to biomass-based materials, that they make more extensive use of environmentally benign solvents, and that they involve chemical engineers early in the development of chemical synthesis processes.

The workshop also scrutinized ongoing voluntary efforts by the chemical industry to produce data on commercial substances.

One of those initiatives is the High Production Volume (HPV) Challenge Program. This initiative, launched in 1998, is a joint effort by EPA, ACC, and Environmental Defense to produce and make public basic toxicity information--such as health and environmental effects, environmental fate, and physical properties--for thousands of HPV chemicals. These substances are made in or imported into the U.S. in amounts exceeding 1 million lb per year. HPV substances comprise 90% of the volume of chemicals in commerce, said Gregory G. Bond, corporate director of product responsibility for Dow Chemical.

John M. Balbus, senior scientist and director of the testing program for Environmental Defense, said the HPV Challenge Program shows that industry can deliver data on chemicals faster than if the government issued a regulation requiring companies to produce this information. However, assessing the quality of data produced by the HPV Challenge Program is difficult, he said.

Thus far, companies have pledged to produce data on more than 2,200 of the approximately 2,800 HPV substances in U.S. commerce, and EPA is beginning to receive this data. Balbus attributes success of the HPV program to its focus on basic hazard data. The program does not involve collection of exposure information. Both hazard and exposure data are needed to assess the risk posed by a substance.

Balbus also discussed the Voluntary Children's Chemical Evaluation Program, launched in 2001, in which EPA is asking chemical manufacturers to voluntarily test 23 widely used substances that children are exposed to in everyday life. Participating companies are also collecting exposure data for these substances. The industry sponsors will integrate both types of information in a risk assessment.

COMPANIES doing risk assessments in the Voluntary Children's Chemical Evaluation Program face a conflict-of-interest situation because the information they provide will reflect on the safety of their products, Balbus argued. He said the job of assessing risk should remain in the hands of the government.

Meanwhile, Balbus called on industry to form a voluntary testing program on nanomaterials. This program would form a "road map for trust" of nanomaterials, especially if it included ecological studies as well as basic toxicity testing, he said.

Precautionary versus risk-based approaches to regulation of chemicals was also examined at the workshop.

Bernard D. Goldstein, dean of the University of Pittsburgh's Graduate School of Public Health, said risk assessment, viewed as the antithesis of the precautionary principle, has precautionary aspects. For example, risk assessments rely on conservative "default assumptions" when needed data are not available, he noted, and they often use safety factors to ensure the protection of sensitive groups such as children or people with compromised immune systems.

While precautionary approaches are often criticized for lacking a scientific basis, risk assessment has its down sides, too, Goldstein said. Risk assessment tends to encourage companies to adopt the least expensive available pollution control technology that will be able to ensure their compliance with environmental standards, rather than encouraging pollution prevention, Goldstein said.

The proposed REACH legislation, which would change how chemicals are regulated in the 25 countries of the EU, figured prominently in discussions of precaution versus risk assessment.

Robert H. Donkers, environment counselor at the EU office in Washington, D.C., said REACH would require producers to show that their chemicals are safe for the uses to which they are put. This involves assessment of risk, not precaution, he said. REACH would only invoke precautionary measures if industry does not provide data on hazard and exposure for a substance, he said.

Donkers attacked industry criticism that the REACH program demands too much data, especially about how chemicals are employed by downstream users. If chemical makers do not know how their products are used, "how can you say Responsible Care has product stewardship?" Donkers asked, referring to ACC's industry performance initiative.

Lynn R. Goldman, professor at Johns Hopkins University's Bloomberg School of Public Health, expressed concern to the workshop that if or when REACH takes effect, the U.S. could become a "dumping ground" for chemicals no longer acceptable in the EU. John Buccini, a consultant to the United Nations Environment Programme, suggested that a global approach to chemical management is needed. Otherwise, chemical risks will just get redistributed throughout the world when one country or region restricts or bans a substance.

Overall, workshop participants came to no definitive conclusions about its title, "Global Environmental Health in the 21st Century: From Governmental Regulation to Corporate Social Responsibility." But its discussions are likely to serve as a springboard for further explorations of the link between command-and-control regulations and voluntary industry actions on environmental protection.