Government Concentrates

DOE advised to rethink grout plan

The Department of Energy should consider postponing its plan to seal 51 underground tanks containing radioactive waste at its Savannah River nuclear weapons facility until more effective waste-removal technologies are developed, according to the National Research Council. Rather than sealing the tanks as soon as the bulk of the waste has been removed, waiting five to 10 years would give DOE time to overcome obstacles to using emerging technologies that could remove more of the residual waste and better immobilize what is left in the tanks, NRC says. After removing most of the radioactive waste, DOE plans to fill the tanks with concrete grout to close most of them permanently. But NRC says the department should not rush to grout all the tanks--"a step that is practically irreversible"--because the small amount of residual waste left in the tanks is unlikely to cause significant contamination of the environment. "DOE should decouple tank waste removal and tank closure actions on a case-by-case basis where there are indications that near-term techniques could become available to remove [wastes] more effectively, safely, or at a lower cost," NRC advises.

Human testing rule violates Congress' intent

EPA has drafted a new 76-page proposal on the controversial issue of testing pesticides and other toxic chemicals on human subjects. The proposed rule, which was submitted on Aug. 1 to the Office of Management & Budget for review, contains some safeguards not included in the previous draft, but violates some of the provisions on human testing that were written into the agency's fiscal 2006 appropriations bill passed on July 26. The draft does establish a human studies review board to decide whether human experiments meet current ethical standards, but it fails to specifically prohibit tests on pregnant women, infants, and children as required by language in the appropriations bill. It also allows EPA to consider studies submitted in the past few years that violate standards set forth in the 2004 National Research Council report on intentional human dosing. This, too, conflicts with congressional language stating that human experiments must be consistent with principles in the NRC report. On Aug. 10, Sen. Barbara Boxer (D-Calif.) wrote to EPA Administrator Stephen L. Johnson, "I see this [proposed] rule as an arrogant response by EPA to congressional direction meant to protect the most vulnerable of our citizens from unethical testing."

NAFTA rejects Methanex claims

An international tribunal last week rejected a Canadian chemical maker's challenge to a California policy designed to protect its drinking water. Vancouver-based Methanex produces methanol as a feedstock for the gasoline additive methyl tert-butyl ether (MTBE). The company challenged California's decision to phase out use of the substance, which has tainted drinking-water wells in the state. Methanex filed its claim under a portion of the North American Free Trade Agreement that prevents governments in Canada, Mexico, or the U.S. from passing regulations that harm investments in their country that are made by businesses based in any other NAFTA nation (C&EN, April 14, 2003, page 31). Methanex argued that California's move to eliminate MTBE would hurt its business and sought $1 billion in damages from the U.S. A NAFTA tribunal dismissed the company's claims and ordered Methanex to pay the U.S. $4 million to cover the government's legal fees and other costs in the case.

NIH needs to tighten ethics review process

NIH needs to improve the quality and the extent of information that it requires for outside activities requests from senior staff and to fix inadequacies in its review process, according to a report by the Department of Health & Human Services' Office of the Inspector General. The study findings are consistent with those of recent congressional and media investigations into ethics problems at NIH. The report examined the outside activities of the agency's senior-level employees that occurred between 2001 and 2003. The findings show that of the 174 senior-level employees at NIH during this period, 78 requested approval for 355 outside activities. Of these requested activities, 90% (319) were approved for 69 employees. Nearly 90% of these activities involved some compensation, the report notes. In nearly a third of the approved cases, at least one piece of required information was not provided in the request, and in 28% of the cases, approval came after the activities' start date. "We concur with your findings, conclusions, and recommendations," wrote NIH Director Elias A. Zerhouni in response to the report, adding that the agency has "taken significant steps to address the identified vulnerabilities, and we have implemented several corrective actions."

Senator seeks inquiry into insider trading

When doctors agree to test new drugs in clinical trials, they promise to keep the research secret until the pharmaceutical firms that developed the drugs announce the results. On Aug. 7, however, the Seattle Times reported on 26 cases in which physicians at leading research universities and institutes revealed confidential clinical trial information to Wall Street analysts and investors. These revelations often had large effects on drug stock prices. On Aug. 8, Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) asked the Department of Justice and the Securities & Exchange Commission to conduct a "complete and thorough review" of the Seattle Times's allegations. "Selling drug secrets violates a trust that is fundamental to the integrity of both scientific research and our financial markets," he wrote. According to the article, the physicians were paid to conduct clinical trials and paid $300 to $500 per hour by Wall Street firms to reveal drug trial data. If the allegations are true, the physicians could be found guilty of violating contractual agreements, and the Wall Street firms could be convicted of insider trading.