From the Hill – Fall 2005

Energy bill signed, little impact seen on oil and gas use

After several years of impasse in Congress, President Bush on August 8 signed into law a bill that includes a broad range of energy-related activities and R&D. However, according to most analysts, the new law is unlikely to have a significant near-term impact on the nation’s use of fossil fuels.

The new law seeks to achieve its goals of diversified energy production and conservation mainly through the use of tax credits: $2.8 billion for investment in clean coal technology, $3.2 billion for renewable energy production, $2.6 billion for oil and gas production, and $2.7 billion for conservation and energy efficiency.

The law also requires the annual use of 7.5 billion gallons of ethanol, a corn derivative, by 2012. The production of ethanol, an additive that helps gasoline burn more completely and thus helps reduce air pollution, is controversial because it largely benefits one producer, Archer Daniels Midland.

The law also authorizes more than $31 billion for basic science and applied energy technology research over three years—more than double what is currently authorized. However, it is far from clear that this amount would actually be appropriated. Energy research was funded at $3.6 billion in the fiscal year (FY) 2005 budget. President Bush proposed $3.46 billion for FY 2006.

In recognition of the fundamental role that science plays in fulfilling the missions of the Department of Energy, the bill creates an undersecretary of science in the department.

Two provisions that have sidetracked energy legislation in the past—energy production in the Arctic National Wildlife Refuge and the elimination of liability for manufacturers of MTBE, a gasoline additive that has caused groundwater contamination—were deleted from the bill.

In addition, in the conference committee that negotiated the final bill, several Senate-passed provisions—a mandatory climate change strategy, a requirement that utilities use a certain amount of renewable energy, and a direction to the president to find ways to cut the nation’s oil use by one million barrels a day—were eliminated. The new law does, however, include language that encourages voluntary efforts to reduce greenhouse gas emissions.

The new law arguably weakens nuclear nonproliferation controls by allowing operators of nuclear reactors in other countries to continue to receive U.S. supplies of highly enriched uranium if they produce medical isotopes. The major beneficiary would be Nordion, a Canadian company that supplies most of the medical isotopes used in the United States. A provision in a 1992 law had required that all recipients of uranium supplied by the United States convert to low-enriched uranium as soon as is technically feasible.

House seeks to shore up NASA science missions

The House on July 22 reauthorized the National Aeronautics and Space Administration (NASA), but only after taking steps to ensure that the space agency does not neglect its basic science missions.

The House bill requires appropriators to allocate money to four separate accounts: Science, Aeronautics and Education; Exploration Systems; Space Operations; and the Office of the Inspector General. Funds for administration and construction of facilities must be included in each of the four appropriations. However, NASA may transfer funds between these accounts with 30 days notice to Congress, and there is no mechanism for Congress to forbid the transfer of funds.

For fiscal year 2006, the total authorization of $16.471 billion includes $6.870 billion for Science, Aeronautics, and Education; $3.181 billion for Exploration Systems; $6.387 million for Space Operations; and $32.4 million for the Office of the Inspector General. Within the Science, Aeronautics, and Education account, $962 million is allocated for aeronautics, $150 million for a Hubble Space Telescope servicing mission, and $24 million for the National Space Grant College and Fellowship Program.

The bill also requires NASA to place greater emphasis on education, technology transfer, safety, and microgravity science research unrelated to human space exploration. NASA is required to report to Congress on its safety management culture and compliance with the recommendations of the Columbia Accident Investigation Board, as well as its plan for identifying and sharing best practices. In addition, the bill removes the requirement that the space shuttle must be retired by 2010.

The bill must now be reconciled with a Senate bill that does not mandate a return of humans to the Moon and that recommends that use of the shuttle continue until the Crew Exploration Vehicle is ready for flight.

Frist backs stem cell legislation

Senate majority leader Bill Frist (RTN) surprised Washington by announcing that he supports legislation that would loosen President Bush’s restrictions on controversial embryonic stem cell research. In a speech on July 29, Frist said that,“The limitations put in place in 2001 will, over time, slow our ability to bring potential new treatments for certain diseases. Therefore, I believe the president’s policy should be modified.”

The Stem Cell Research Enhancement Act, which passed the House by a 238194 vote in May, would expand the number of stem cell lines available to federally funded researchers. The Bush policy anticipated that many more stem cell lines would be available than has actually been the case.

Senate champions of the legislation hope that Frist’s support will provide enough political cover for other senators to provide a veto-proof majority. But President Bush remains opposed to the legislation, and a two-thirds majority to overturn a veto is unlikely in the House. In addition, there is still uncertainty over what the Senate legislation will include. For example, Frist said he intends to seek revisions to ensure “a strong ethical and oversight mechanism.”

House considers major reorganization of NIH

A July 19 House Energy and Commerce Committee hearing provided the first public unveiling of its draft bill for a major reorganization of the National Institutes of Health (NIH) that would give the director much more authority. The plan would consolidate the existing 27 institutes and centers that make up NIH into two entities—mission-specific research institutes and science-enabling institutes—in addition to the Office of the Director (OD). The mission-specific division would include the existing disease-related institutes, and the science-enabling division would contain the general medical science portfolio.

The plan would also create a Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI) within OD, responsible for coordinating research among institutions. It would have the power to finance research directly.

The mission-specific and science-enabling divisions would be required to set aside an as-yet-to-be-determined part of its funds (5% has been informally discussed) for a “common fund for the common good” within DPCPSI, which would use the funds to support multidisciplinary research that intersects institutional missions, a priority of NIH Director Elias Zerhouni. According to the draft language, the NIH director would be responsible for establishing an advisory council to provide recommendations on how to conduct and support transinstitutional research.

The House Energy and Commerce Committee proposal requires that the director submit a biennial report to Congress that includes an assessment of the “state of biomedical research,” a description of all activities “conducted or supported by the agencies,” a justification for the “priorities established by the agencies,” and a catalog of all research activities, in addition to other information. Members of Congress want this information as a way to keep tabs on how NIH makes decisions on investing in disease-related research. Patient/medical research groups, however, are concerned that this will be too onerous to maintain and take up too much time and money. Zerhouni has recommended a more “streamlined” approach to reporting to Congress, without going into details about what that means.

The draft bill has been met with mixed and subdued reaction. Patient organizations have expressed concern about the possibility that mission-specific institutions would lose authority to fund research. Research organizations have expressed concern about the vaguely defined roles of the coordinating office and advisory council.

Even members of Congress, who understand the need to give the director more power in spending decisions, are hesitant about embracing the plan. Rep. Henry Waxman (D-CA) said that if the agency is not broken, caution should be used before initiating any organizational changes.

Zerhouni, meanwhile, diplomatically stated that he agrees that the committee “should first and foremost carefully reconsider how the organizations of NIH can collectively and effectively support the core missions of the agencies. The challenge is to accomplish this goal through enhanced coordination and partnerships across the NIH institutes and centers while avoiding the pitfalls or centralization or top-down research. Achieving the right balance, the necessary autonomy, and diversity of approaches represented . . . is the central question.”

Congress critical of slow pace on bioweapons prevention

Concerned that the federal effort to thwart potential bioweapons attacks is not providing results quickly enough, Congress is considering bills to bolster the program, called Bioshield.

Members of Congress were sharply critical of Bioshield at a House Homeland Security Committee hearing on July 12, despite testimony from Department of Homeland Security (DHS) and Department of Health and Human Services (HHS) officials that the program was succeeding. Lawmakers were upset by the lack of a stockpile of antiviral drugs and by the time it took to identify priority diseases. At a July 14 House Government Reform Committee hearing, it was revealed that a year after Bioshield began, the government has entered into only three contracts for countermeasures.

Industry representatives at the second hearing said that the current program does not give their companies enough incentive to develop new countermeasures. They said that companies cannot determine whether they will earn a profit on a new countermeasure, because they do not know in advance how many doses of their products the government will buy.

In response, two bills to revamp Bioshield by guaranteeing the profitability of countermeasures have been introduced in the Senate. Sen. Judd Gregg (R-NH) introduced S. 3, the Biopreparedness Act of 2005, which is supported by the Republican leadership. Sen. Joseph Lieberman (D-CT) introduced S. 975, the Project BioShield II Act of 2005, which is cosponsored by Sens. Orin Hatch (R-UT) and Sam Brownback (R-KS).

Both bills extend the term of the patent for a countermeasure by the amount of time between when the patent was issued and when the countermeasure was approved by the Food and Drug Administration. They also permit the secretary of HHS to grant an extension of 6 to 24 months to the term of an unrelated patent owned by a company that is developing a countermeasure. Both create tax credits for conducting research or building factories for countermeasures or vaccines.

Each bill also contains a number of other measures intended to improve Bioshield. These include accelerated approval of countermeasures, partial immunity for harm caused by a remedy for a pandemic or epidemic, new National Institutes of Health and DHS offices to coordinate responses to bioterrorism, grants and scholarships for bioterrorism research, new procurement procedures, and limits on the ability of states to require drug safety or warning label information not mandated by federal law.

Both bills have been criticized by consumer advocates and generic drug manufacturers for being too generous to the pharmaceutical industry.

Cite this Article

“From the Hill – Fall 2005.” Issues in Science and Technology 22, no. 1 (Fall 2005).

Vol. XXII, No. 1, Fall 2005