Guidelines issued by the U.S. EPA on October 1 should improve the quality of the science disseminated by the agency and the data and analyses used to support rulemakings. Developed to comply with the Data Quality Act, which Congress approved in the waning days of the Clinton administration, the guidelines will allow outside groups to legally challenge any information distributed by the federal government at any stage of development, including when the information is in draft form. The new guidance leaves business advocates cheering and environmentalists jeering, because they both predict the guidelines could delay controversial actions at EPA. High-profile projects at EPA, including its long-awaited dioxin report, perchlorate toxicological review, and policy decisions on human testing are likely to face challenges under the new act because they discount contradictory but scientifically valid data or analyses, predicts Jim Tozzia, founder of the Center for Regulatory Effectiveness, a group funded by trade associations. Passed without any hearings as an amendment to an appropriations bill, the Data Quality Act tells all federal agencies to issue guidelines that ensure and maximize “the quality, objectivity, utility, and integrity of information” the government disseminates. In January, the Office of Management and Budget (OMB) took the first step of implementing the law by releasing guidelines explaining how the agencies must comply with the act. OMB’s guidelines emphasize independent peer review as one way to demonstrate objectivity. But “influential information”—analyses and information likely to affect important public policies—is to be held to a higher standard. The analyses must be reproducible, OMB wrote. This means federal agencies must reveal the assumptions and equations used to develop an analysis. They must also provide all of the uncertainties associated
with underlying risk assessments and name the studies that might dispel the uncertainties. In short, qualified outside parties should be able to obtain the same answer as the government, says OMB Office of Information and Regulatory Affairs Administrator John Graham. OMB called on agencies to make it easier for the public to challenge data or analysis at any point in the rulemaking process, even when rulemakings are issued as drafts. What makes this different from the public comment input the government usually receives is that groups can immediately seek judicial review of their complaint if the agency disagrees, even before the rule is final, say a number of attorneys specializing in regulatory law. Business interests are eager to challenge EPA under the new law. “This act has enormous implications,” says William Kovacs, vice president for environment, technology and regulatory affairs at the U.S. Chamber of Commerce. Critics can legally challenge rules based on the assumptions used in the analytical models for pinpointing what the pollution control levels should be, or for determining the overall control strategy, says Kovacs. Environmentalists and some researchers say they are concerned the guidance could affect EPA’s ability to make decisions, especially those based on fairly new or controversial research. The Data Quality Act is largely aimed at EPA, because its regulations are often based on emerging science and can have a major impact, asserts Alan Morrison, co-founder of the Public Citizen Litigation Group. It imposes sweeping responsibilities on EPA for ensuring data quality apparently without any additional funding, he adds. Others assert the act will only burden agencies that put out bad data. “If the data and analysis are good, you’re just fine,” says Tozzia. Guidelines can be found at www. epa.gov/oei/qualityguidelines/ index.html. —REBECCA RENNER
News Briefs Food needs water If current water policies continue, farmers will not have enough water for irrigation to meet the world’s food needs by 2025, according to a new report by the International Food Policy Research Institute and the International Water Management Institute. Under business-as-usual, global annual losses in food production are predicted to reach 350 million metric tons by 2025 because of water scarcity. If current trends worsen and a water crisis ensues, food production is predicted to decline significantly, causing prices to skyrocket. On the other hand, if total global water consumption is reduced by 20% over business-as-usual levels and industrial demand for water decreases by 35%, food production is predicted to slightly increase and food prices to decline slowly by 2025. Global Water Outlook to 2025: Averting an Impending Crisis can be downloaded for free at www. ifpri.cgiar.org.
Toxics in fish tissue The concentrations of 265 persistent bioaccumulative toxics in fish tissue from the first random nationwide U.S. survey are now available on the U.S. EPA’s Web site. Over a four-year period, EPA is collecting fish from 500 lakes and reservoirs and analyzing tissue for metals, dioxins and furans, polychlorinated biphenyls, pesticides, and polycyclic aromatic hydrocarbons. EPA aims to provide a baseline to track the progress of pollution control efforts and identify toxic hotspots in the country’s lakes, 23% of which are under fish consumption advisories. The National Study of Chemical Residues in Lake Fish Tissue can be viewed at www.epa.gov/waterscience/ fishstudy.
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Little law could block major government decisions
Environmental▼News More evidence that atrazine may affect frog sexuality ing sites chosen as controls because of low reported atrazine usage. To date, most of the published studies that show endocrine disruption in frogs have been laboratory studies focused on the African clawed frog, Xenopus laevis, which MARCEL MORGENSTERN
New research shows that exposure to low levels of the popular herbicide atrazine feminizes male northern leopard frogs, Rana pipiens, both in the laboratory and in the field and “raises concerns about the effects of atrazine on amphibians in
Research on northern leopard frogs exposed to atrazine indicates that the endocrine systems of all amphibians may be disrupted by the popular herbicide.
general,” according to Tyrone Hayes and his colleagues at the University of California–Berkeley’s Laboratory for Integrative Studies in Amphibian Biology. Hayes’s research was published in Environmental Health Perspectives (DOI 10.1289/ehp.5932) and as a communication in Nature in late October. The publications came at a crucial time because the U.S. EPA is under a court deadline to publish its preliminary reassessment of the risk posed by atrazine next month. The paired studies are the first peer-reviewed research to show effects on both wild and laboratoryraised specimens of R. pipiens at levels of atrazine found in the environment, down to 0.1 parts-per-billion (ppb)—which is 30 times lower than the current U.S. drinking water standard, Hayes says. The Berkeley researchers found atrazine contamination at all of the eight sites where they collected leopard frogs, includ-
is native to sub-Saharan Africa. Last year, Hayes presented research linking exposure to 0.1 ppb of atrazine in the lab to gonadal alterations in male X. laevis frogs (Environ. Sci. Technol. 2002, 36, 55A–56A). Other researchers have thus far been unable to duplicate Hayes’s findings, although their attempts to repeat his laboratory work were complicated by the fact that they were unaware of the actual experimental conditions Hayes used when they started their efforts, says Keith Solomon, director of the Centre for Toxicology at Canada’s Guelph University. A report on this research is due out this month. The northern leopard frog was once the most widespread frog in North America, but it has been disappearing from many of its previous habitats, according to the provincial government of Alberta, Canada, one of the places the species is “red-listed”. Hayes says he picked R. pipiens, together with a
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third frog on which he has yet to publish data, the Pacific tree frog, with the goal of amassing data on three very different species of frogs. EPA expects to issue its final atrazine risk assessment by October 2003, says Dave Deegan, an EPA spokesperson. Atrazine is manufactured by a number of companies including Syngenta, a Swiss firm, and it is the most popular herbicide in the United States and perhaps the world, according to EPA. Among the most controversial findings in both Hayes’s current research with R. pipiens and his earlier X. laevis work is that lower concentrations of atrazine, on the order of 0.1 ppb, appear to be more likely to induce male frogs to develop feminine characteristics than doses of 25 ppb. Both studies imply that there is a parabolic, or inverted-U-shaped, dose–response relationship for this hermaphroditism, Hayes writes in the Environmental Health Perspectives paper. “This is a topic that a lot of ecotoxicologists are interested in because we know that organisms have detoxification systems but they seem to only be turned on at a threshold level of contamination, so below that, the hypothesis is that the chemical can be having some sort of effect which is not seen at higher concentrations because of induction of some metabolic protection,” says Stanley Dodson, a freshwater ecologist at the University of Wisconsin–Madison. However, “it’s difficult to build a dose–response relationship for two concentrations—you’re talking about a 250-times difference between the concentrations,” objects Jim Carr, an associate professor of biology and endocrinology at Texas Tech University, who is one of the scientists trying to repeat Hayes’s X. laevis findings. “I’d really like to see more data points,” Solomon adds, noting that some endocrinedisrupting chemicals have been reported to show such an unusual dose–response curve, but a simpler explanation needs to be ruled out.
of the frogs examined by the researchers had abnormalities, but more than 90% of the frogs at the second site were hermaphroditic. However, “in studies that I am undertaking in South Africa, I looked at frogs (Xenopus laevis, Afrana (Rana) angolensis, and Afrana fuscigula) from corn production areas where atrazine is being used extensively. I have not observed the intersex cases that Hayes et al. [are] referring to. There are a number of factors that can and do affect differentiation of gonads in amphibians and reptiles,” says du Preez. For example, Carr says that wild intersex Rana frogs were reported for decades before atrazine’s use began in the 1950s. Hayes’s paper argues the sex changes his team observed are different than those described previously. “They’re completely unrelated phenomenon. . . . In other Rana [species], there’s been a natural intersexuality described that’s presumably normal. That anatomy is a mixture of testes and ovaries. What we’re showing is that animals with testes have eggs in their testes—they don’t have ovarian tissue,” Hayes says. Carr remains unconvinced. “There [are] a lot of reasons why you might see something like [oocytes in testes],” he says. Hermaphroditism can be caused by environmental factors other than atrazine, such as temperature fluctuations and the concentrations of nutrients like calcium and magnesium in the water, Solomon adds. The debate over whether or not atrazine affects frogs—or other amphibians—is unlikely to end soon, as Hayes questions how closely the research intended to repeat his results has followed his experiments. To make matters even more interesting, he is beginning to evaluate the effects of some of the mixtures found in natural settings, including combinations of 10 different herbicides, insecticides, and fungicides. “It’s going to blow this current thing out of the water: thresholds change, the effects are enhanced in ways you would not predict,” Hayes says. —KELLYN BETTS
News Briefs EPA’s power questioned ... The U.S. EPA acts as lawmaker, prosecutor, judge, jury, and executioner all in one when enforcing national standards, according to a new book from the libertarian Cato Institute, a nonprofit education group. In Out of Bounds, Out of Control: Regulatory Enforcement at the EPA, author James DeLong writes that strict compliance with all environmental laws is difficult and oftentimes impossible, which allows EPA enforcement staff to “take action against any regulated entity it chooses to attack.” DeLong uses specific enforcement cases to illustrate his point that EPA’s enforcement efforts are arbitrary. For a copy, go to www.cato.org.
... or is it underused? The U.S. EPA under President Bush has issued 40–50% fewer enforcement actions against companies than it did during the previous administration, according to an analysis released by Rep. Edward Markey (D-Mass.). Using data supplied by the EPA, Markey’s staff analyzed the number and quality of administrative actions issued and settled during two comparable periods of both administrations. In addition to less enforcement, the researchers found that the total cost of penalties recovered from these actions dropped by more than 80% during the Bush presidency when compared to the costs recovered during the Clinton administration. The report can be found at www.house.gov/markey/ iss_environment.htm.
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Hayes claims to have more unpublished data to support his contention. He also stresses that he was surprised by the finding. “We didn’t set out to figure out if there was a dose–response. . . . We were doing a screen to determine if multiple populations [of different species] showed the effect. So we weren’t trying to go through and figure out threshold effects. We’re doing that now,” he says. Solomon points out that the concentrations of atrazine reported in Hayes’s field studies don’t actually tell much about the concentrations of the chemical to which the animals were exposed, a fact that Hayes acknowledges in his paper. The weekly atrazine concentration data that Solomon has been collecting in South Africa in conjunction with Louis du Preez, an associate professor of zoology in the School of Environmental Science and Development at South Africa’s Potchefstroom University for Christian Higher Education, show how wildly levels can fluctuate. “Depending upon rainfall, we have numbers going from 1 or 2 to about 11 ppb,” says Solomon, adding that the U.S. Geological Survey data for atrazine levels in the United States show similar fluctuations. “We have no idea what [the frogs Hayes examined] were exposed to during their metamorphosis,” which is a key time for sexual development, Solomon adds. Hayes agrees that it is impossible to correlate the number of hermaphrodites with his atrazine measurements. “It’s a one-time measure, and all it shows is where you have hermaphrodites, you have atrazine—it doesn’t tell you anything about the level of exposure,” he says, noting that he has only been able to make limited atrazine measurements because of the expense involved. This lack of correlation between the measured levels of atrazine and the percentage of frogs with gonadal abnormalities explains why two of Hayes’s sites that were observed to contain 0.2 ppb of atrazine had dramatically different populations, he says. At one site, less than 10%
