Issue Date: February 23, 2004
House questions NIH hiring practice that pays high salaries
A House Energy & Commerce subcommittee is questioning NIH about its use of Title 42 USC 209(f) of the Public Health Service Act to pay institute directors and other senior NIH officials higher salaries than otherwise might be allowed. The law's provision permits "special consultants" at the agency to be compensated at salaries higher than those possible through the government payroll system. In a letter sent to Health & Human Services Secretary Tommy G. Thompson earlier this month, Oversight & Investigation Subcommittee Chairman James C. Greenwood (R-Pa.) expressed concern that NIH was misusing this special authority by "employing NIH institute directors and other high-level NIH officials, who occupy continuing, full-time positions and exercise broad-based levels of decision-making responsibility," as opposed to using the authority as intended to attract consultants, who by definition have limited responsibilities. The letter asks NIH to justify and provide details of its use of this practice. NIH is expected to reply to Greenwood's request soon.
FDA lists steps to fight fake drugs
A report by an internal FDA task force lists steps that can be taken to combat the growing problem of counterfeit drugs. Some of the measures can be implemented immediately, and others require further technology development. The steps include adopting track-and-trace technologies, such as radio-frequency identification chips, on drug packages and vials; using authentication technologies, such as taggants and color-shifting inks, on capsules and packages; creating a national list of drugs most likely to be counterfeited; strengthening state requirements governing licensure of wholesale drug distributors; increasing criminal penalties for counterfeiters; developing a system that ensures timely reporting of counterfeit drugs to FDA; and collaborating with the World Health Organization and Interpol to develop strategies to deter counterfeiting globally. "FDA will lead the way in taking the steps necessary to keep our nation's drug supply safe and secure," FDA Commissioner Mark B. McClellan says.
Energy bill to return to Senate
A reworked energy bill is expected to come to the Senate floor this week, according to Senate Majority Leader Bill Frist (R-Tenn.) and Sen. Pete V. Domenici (R-N.M.). The bill (S. 2095) is a slightly smaller version of an energy bill that cleared the House last year but was blocked from reaching the Senate floor, mostly because of Senate opposition to provisions--now gone--giving product liability protection to methyl tert-butyl ether producers. MTBE is a gasoline additive that has polluted groundwater in several states. The revised bill addresses another stumbling block to passage--cost--by reducing the previous bill's 10-year price tag from $32 billion to approximately $14 billion. It retains several tax provisions, however, including funding incentives for clean coal, natural gas, and conservation. It also contains provisions calling for greater use of ethanol in gasoline. If the revised bill clears the Senate, it must return to the House, where members strongly support the MTBE provisions and some of the tax breaks that were cut. President George W. Bush has said he wants a bill that costs less than $9 billion, and some Senators are questioning whether the bill's cost estimates may be too low, considering that the estimates do not include the price tag for new programs that are required in the bill. Several Democratic senators have also warned that they will add amendments on the floor because this bill, like the last energy bill, was crafted with input only from Republican leadership.
Report warns of lost U.S. nuclear material
The U.S. government has lost control of some 14,000 kg of highly enriched uranium since it began the Atoms for Peace program in the mid-1950s, according to a recent report by the Department of Energy inspector general. An inspector general audit found that DOE had given or sold the material to several countries for research purposes and was unlikely to be able to recover the material, which could be used for nuclear weapons. The inspector general recommends shifting the program from DOE's Office of Environmental Management, which is primarily responsible for cleanup activities, to the National Nuclear Security Administration. The report identified 33 countries that have received U.S. materials and singled out 12 of them--including Pakistan, Iran, Israel, Mexico, and Jamaica--that say they are unlikely to return it.
Mercury rule for chlor-alkali plants disputed
Environmental groups are suing EPA over a Clean Air Act rule controlling mercury emissions from chlor-alkali chemical manufacturing plants. The rule, issued in December, applies to the nine U.S. facilities that use mercury cells like those shown below to produce chlorine and sodium hydroxide (C&EN, Jan. 5, page 10). The Natural Resources Defense Council and Sierra Club contend that the rule fails to protect public health from the dangers of the neurotoxic metal and violates the Clean Air Act. The rule eliminated a plantwide emissions cap for mercury, a standard that had been in place since the 1970s. EPA replaced it with an allowable release rate for mercury at certain emission points at plants, and the agency established new work practices, such as regular inspection of mercury cells for leaks. The environmental groups contend that EPA needs to set a standard for evaporative emissions from mercury cells. In the rule, EPA acknowledges that "significant mercury remains unaccounted for" by chlor-alkali plants. The environmental groups filed their suit in a federal appeals court on Feb. 17.
Revised climate-change research plan should be implemented
The Administration's revised research plan on climate change is a great improvement over the previous plan presented last year and should be implemented vigorously, a National Research Council report says. The climate-change plan was written by the U.S. Climate Change Science Program (CCSP), a group formed two years ago to coordinate global change research among 13 federal agencies. "Advancing the science called for in the plan will be of vital importance to the nation," says NRC committee Chairman Thomas E. Graedel, professor of industrial ecology at Yale University School of Forestry & Environmental Studies. The committee praises the plan's new emphases on technologies to address climate change and on understanding how climate change will affect ecosystems and people. However, the newer and expanded areas of the plan are likely to be underfunded, the panel says. For example, the research budget is not large enough to expand the climate-change observing systems or to improve the computer models used to project future climate changes. The committee also warns that political appointees in CCSP management may exert "political influence" that could interfere with the "scientific independence and credibility" of CCSP's research efforts.
NRC panel okays human toxicity studies
A National Research Council panel has concluded that EPA should consider data from studies that involve intentional dosing of humans with toxic chemicals, but only if the experiments meet strict scientific and ethical standards. The NRC report, "Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues" addresses the controversy surrounding whether EPA should accept data from experiments on humans performed by pesticide makers trying to demonstrate that their products might be safer than lab animal tests indicate. The panel recommends a tight framework for approving any human studies of toxic chemicals, including requirements that the benefits to society outweigh individual risks, that the study be scientifically valid, and that all recognized ethical standards and procedures for protecting participants be followed. The panel noted that third-party human experiments are used in other venues. It said specifically that there were similarities between intentional human dosing studies and Phase I pharmaceutical testing, "especially because neither offers a reasonable prospect of direct benefit to the research participant." Reactions to the report's recommendations varied. The Environmental Working Group (EWG), an group active in this issue, is concerned the report will be seen as a "green light" to the industry to do more tests. "If EPA begins to accept human experiments, we expect to see companies take advantage of any and all ambiguities in the guidelines," EWG Senior Vice President Richard Wiles says. The Natural Resources Defense Council says the report is "gravely disturbing" in that it would allow human tests. NRDC takes particular issue with the idea that, even under the most restricted conditions, the report finds it acceptable "for the chemical industry to test toxic chemicals on children." In contrast, CropLife America, which represents agricultural chemical makers, supports the findings of the NRC report. "We agree with the major finding that human testing is ethical, provided there are safeguards and sound science is used," the group says in a statement. The report can be found online at http://www.nap.edu.
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