New Approaches to Environmental Regulation
Science and Economics Prominent on EPA Agenda
Expertise can be a critical force if it can keep ideology in check.
Although President Bush made very few campaign promises about the role of science in public policymaking, observers say that the incoming administration will likely enhance the role of risk assessment and economic analysis in its decisionmaking at the Environmental Protection Agency (EPA). In response to confirmation-related questions, EPA administrator Christine Todd Whitman indicated that she would support the long-standing traditions of "precaution, science-based risk analysis, and sound risk management, including consideration of benefit/cost."
Past administrators William Ruckelshaus, Lee Thomas, and Bill Riley all used the risk paradigm as an organizing principle for the EPA. The questions of how big a threat is, how much it costs to do something about it, and how it compares with other risks were all framed by those leaders in risk language. But under Carol Browner, EPA headquarters for the most part let the risk framework fall by the wayside.
Many environmentalists have negative associations with risk because of the regulatory reform legislation they opposed in the 1990s. "Risk assessment" became a hot button issue that activists associated with the rollback of safeguards promised under Newt Gingrich's "Contract with America." The emphasis on assessing regulations with the help of a cost-benefit template, where an action is deemed worthwhile only if its benefits exceed costs, attracted particularly vehement opposition. Thus, the need to work in a bipartisan manner on environmental legislation in a Congress with closer margins may lead the incoming administration to be cautious about invoking risk language and benefit-cost criteria.
Industry representatives are hoping for a less politicized atmosphere surrounding environmental issues. Although many have grudgingly praised the political skills of Carol Browner--in particular the way she used children's health rhetoric to limit the maneuvering room of her opponents--there are perhaps fewer who think Browner effectively integrated science into environmental decisionmaking. One director of a prominent think tank observes that "The last eight years have been so political and ideologically driven, and it's not just Carol Browner. The 1994 Congress polarized the issues as well." Environmentalists, meanwhile, are girding for defensive action to resist changes in what they view as important safeguards.
As they take office, Bush administration officials are inheriting a number of proposals and unresolved science policy debates that may require some early decisions. A proposal to create a deputy administrator for science position at the EPA has won support from a variety of quarters. Members of Congress have introduced legislation creating such a position, and House Science Committee Chairman Sherwood Boehlert (R-N.Y.) has promised to hold hearings this spring. Former and current EPA officials agree that much of what happens at the agency comes together at the deputy administrator level. Ensuring that scientific expertise is at the table when policy options are considered would improve the quality of decisions and their credibility in Congress. And splitting responsibility for research management from responsibility for applying available science to the regulatory and policy arenas would strengthen the scientific basis of these decisions, some EPA sources say. Some of the impetus for these changes came from the National Research Council's spring 2000 report Strengthening Science at EPA: Research Management and Peer Review Practices.
Although some environmentalists have supported the proposal, others are unconvinced, arguing that the appointee could lean toward inaction on important environmental risks by citing scientific uncertainties. EPA science managers are also leery of yet another layer of bureaucracy that could second-guess their assessments and conclusions. Industry sources, however, strongly support the creation of the deputy for science slot. They are pushing for it to be among the first environmental proposals advanced during the new Congress. Should the legislation succeed, agency leaders would have to make crucial decisions about each deputy's role and responsibilities. Agency sources say that the "rules of engagement" structuring input into regulatory and science policy initiatives between the two deputies would be critical in ensuring that the creation of the new slot would enhance decisionmaking.
One initiative begging for resolution is the protracted debate over the draft cancer risk assessment guidelines. The draft guidelines are used to interpret the carcinogenic potential of chemical agents. They were last updated in 1986 and have been at the center of controversies revolving around the protection of children, the use of the most up-to-date science, and the possible relaxation of standards.
Questions are also being raised about how agency initiatives on cumulative risk will proceed. The EPA's pesticide program is mandated to address the cumulative risks under the Food Quality Protection Act (FQPA), and agency risk experts have developed a framework for looking at multiple risks. But some EPA officials are concerned that the agency's focus on cumulative risk and susceptible subpopulations might fall by the wayside under the new administration.
Decisions with major risk and economic consequences are in store for the pesticide program, largely because of cumulative risk requirements. The FQPA mandates that pesticides that share similar biochemical effects must be evaluated as a group. This could lead to the cancellation of many key pesticides. The prospect of upcoming decisions is already reverberating through broad segments of the farming, crop protection, and food processing industries. The EPA may also tackle the triazine class of herbicides, which are widely used on corn crops, from southern Illinois to the Rocky Mountains.
On the last day of the Clinton administration, the EPA entered into a consent decree with the Natural Resources Defense Council that sets out court-enforced deadlines for certain decisions. If accepted by the judge, the decree would establish hard deadlines for certain regulatory decisions and for the conduct of cumulative risk analyses, a policy strongly opposed by industry.
Two other major pesticide policies that could also have strong ramifications in the coming years are the agency's approach to the 10-fold children's safety factor mandated by the pesticide law and the use of research on human subjects in setting pesticide risk levels. The FQPA calls for up to 10-fold reductions in the pesticide residue allowed on foods if the compound is determined to pose particular risks to children's health. The mix of scientific and policy inputs into the EPA's determination of the appropriate factor for various pesticides has already resulted in political static, and litigation is likely to follow however the agency proceeds.
The possible use of human data in pesticide risk assessments is also likely to continue to draw fire. Under the previous administration, studies using human subjects were not accepted for use, and eleventh-hour attempts to formalize the ban were blocked by the White House Office of Management and Budget. Pesticide companies argue that all data should be considered in setting pesticide risk estimates, but environmentalists charge that companies simply want to avoid the 10-fold reduction in allowable pesticide residues that the EPA implements when extrapolating from animal studies to humans.
In the food biotechnology area, making decisions despite scant risk information may continue to create dilemmas for the EPA. The situation that emerged over genetically engineered Starlink corn, which made its way into some human foods even though it had been approved only for animal feed, elevated a number of issues ranging from supply logistics to allergenicity to the precautionary principle. In any event, this is expected to be a dynamic area. New legislation and more White House coordination of the various agencies that oversee pieces of the biotechnology regulatory puzzle may be in the works.
In the area of risk and environmental models, some EPA officials are warning of a growing leadership vacuum on questions of quality and peer review. The majority of agency decisions and rules rely to some degree on modeling work, and the agency is now in the midst of crafting complex multipollutant, multimedia, and multipathway risk models to support waste and air regulations. EPA managers moved aggressively in 1998 to address the issue of the quality control of environmental models, partly at the instigation of EPA science advisors, but some sources say that effort is slackening.
Air, water, waste, toxics
Meanwhile, the EPA's air, water, waste, and toxics offices will also be grappling with many key science policy issues. The Supreme Court recently rejected a lawsuit against the EPA in which the American Trucking Association argued that cost should be a criterion in setting some air quality standards. Because the decision was remanded, industry can appeal again in a lower court, but the high court's 9-0 ruling sent a strong message about the relative importance of health- versus cost-based criteria in setting risk standards. Under the Clean Air Act, cost considerations are allowed to come into play during the implementation stage, when states establish plans for conforming with the air standards.
Another aspect of the Clean Air Act will also be contentious. After technology-based controls for air toxics are placed on factory emissions equipment under the Clean Air Act, the EPA must assess the "residual risks" that remain and manage them. The agency's approach to the residual risk program was criticized by science advisors last year, and after making adjustments, the EPA will be going back for another review this spring. The residual risk program is being carefully watched by industry because of the slew of new controls that may be required if significant risks are not being addressed by the technology-based program.
In addition, a major air toxics prioritization tool--the National Air Toxics Assessment--was reviewed by science advisors in March 2000. This assessment focused on approximately 30 of the most ubiquitous air toxics (based on state reports) and will allow the agency to focus its efforts on the worst risks first. All of these activities could shape the future of air-quality management at the EPA.
The United Nations Intergovernmental Panel on Climate Change recently issued another report calling attention to the risks posed by global warming trends. The extent to which voluntary and international efforts should be pursued in response to these risks is sure to be a focus for an administration aggressively seeking to define and refine energy policy, particularly because some environmental regulations related to power plant emissions may be revamped in order to help California deal with its power shortages.
The water office will continue to focus on dioxin, arsenic, and mercury because of their effects on sewage sludge, water quality, and drinking water standards. Pollution caps on water bodies, known as Total Maximum Daily Loads (TMDLs) under Section 303(d) of the Clean Water Act, will also be a major undertaking that this administration will have to grapple with. These standards address non-point-source pollution from the agricultural and forestry sectors, an area that the National Academy of Public Administration underscored as an important short-term priority in a recent report. Although the controversial standards have a relatively minor risk component, the political, technical, and resource problems associated with them will demand close attention as stakeholders have been successful in building opposition to TMDLs in Congress.
Food safety oversight agencies, the EPA's waste office, and many industry and citizen groups are carefully tracking the Science Advisory Board's dioxin review. It could trigger more stringent cleanup goals for many hazardous waste sites and other environmental and food safety policies. Food is the primary pathway of exposure of concern, since environmental releases have decreased over the past decade. This concern has resulted in the formation of a new National Research Council panel to investigate dioxin exposure issues. Any additional increment of exposure through food is important if the EPA's conclusion is correct that current accumulations in human tissue are approaching unacceptable levels.
The intensity of the activist community's engagement in this latest review is broad and deep. Grassroots organizers from around the country have made heated public comments urging the agency to finalize the review and have demonstrated at science advisors' meetings. They argue that public health is at risk because state and local regulators won't move until the EPA's reassessment, now 10 years in the making, is complete. But others are seeking to hold the EPA to a high standard for the science in the reassessment even if that takes more time. In addition, the chemical industry is carefully weighing legal options, scrutinizing each step of the review for procedural defects.
On another front, the chemical industry, through collaborations with Environmental Defense, a leading environmental organization, and the EPA's toxics program, is generating historic amounts of toxicity data on more than 2,000 high-production-volume chemicals. This blizzard of new screening data will also help the EPA and other environmental agencies set priorities and plan further research. But the impact that the influx of information will have on the public is unclear. Industry, government, and advocacy groups will all have their spin, particularly because Environmental Defense's "Scorecard" Web site will be making all the raw data available and easily accessible. The data on mass-produced chemicals are sure to increase concern about some products, lead others to be reformulated, and spark debates about the health risks of what goes into products such as soap and children's toys.
Finally, the scaled-down Office of Policy, Economics and Innovation has recently released a major set of cost-benefit guidelines, which managers hope will lead to more consistency in the application of economic methods to EPA rules. Whether this administration places more emphasis on the costs and benefits of agency actions will also be of strong interest to observers of environmental matters. The EPA's Whitman has also expressed interest in boosting the development of environmental performance indicators. This would mean that a regional official might have to document a 20 percent improvement in water quality rather than simply providing a list of enforcement actions. The policy office has already published a document on children's environmental health indicators that has been praised for setting out some "leading" indicators in the area. The document provides a broad snapshot that can be compared from year to year to measure progress.
The upshot of all this activity is that science and economics may assume greater prominence in future EPA decisions--if they themselves do not become overly politicized. How capable incoming managers are at keeping science and economics under the ideological radar may be a major determinant of whether calls for a "less strident" political atmosphere can be fulfilled. Advocates on both extremes are certain to test the waters soon.
Steven Gibb (Steve.Gibb@iwpnews.com) is managing editor of Inside EPA's Risk Policy Report.