Government legislation, a few may be done through [existing] regulations," he says. There is Congressional interest in these new enforcement tools and debate over the issue is expected "to heat up" in this legislative session. Although the agency is "going to take enforcement activities up a notch, that doesn't mean there are not other important ways to do the job," he insists. As an example, he points to the important role of education in ensuring safe and useful medical devices. "Enforcement is only one way to carry out the mission, but it is absolutely critical for a strong agency." mmMmaammmmmmmtammmmkmMmmmBmmmmmsmm
I doift believe the agency's problems would be solved if FDA were an independent agency today Kessler likes to call himself "a baby doc," who loves nothing better than to talk about scientific data and new therapeutic advances. But he says, there has to be a sense among the public, Congress, and the media that the agency has the will to carry out its statutory mandates. "If that requires my being a cop, so be it." The commissioner doesn't seem troubled by Rep. John D. Dingell's (D.-Mich.) intense scrutiny of FDA in his role as chairman of the Energy & Commerce Committee and its panel on oversight and investigations. "I come from the Hill. Congress has constitutional responsibilities for oversight." Furthermore, Kessler believes his agency has to earn the respect of Congress. It will do this, he says, when it is strong. And "when the Hill realizes we are strong, they will stop micromanaging us. That's all Dingell wants." When asked if he will micromanage his agency, Kessler answers: "I like to know what's going on. But I am going to let agency managers manage." If the commissioner believes his agency can best function by his giving his managers wide latitude, he 22
March 11, 1991 C&EN
doesn't necessarily see the need for the agency itself to be independent of the Department of Health & Human Services. "I don't believe the agency's problems would be solved if FDA were an independent agency today." And, he notes, there are "distinct advantages for having the Secretary [of HHS] deal with the President's Domestic Policy Council," for example. He says the agency may some day be independent "but not in my lifetime." What he does see happening soon is the imposition of user's fees. "User's fees have to be used to strengthen this agency . . . the order of magnitude of resources this agency needs" requires them. Kessler mentions registration fees and application fees as likely candidates. FDA received four new statutory mandates from Congress in the last session, but didn't receive concomitant increases in resources to carry out these responsibilities. The agency can't stop its surveillance activities, it can't shift resources from its generic drug and AIDS programs into these new programs. So user's fees appear to be an inevitable source of new funds. FDA does not now have legal authority to impose such fees. And who would pay them is still under discussion. But there is no question in Kessler's mind that they are needed "to do the job the American people want us to do." One task the public wants FDA to do well is to ensure the safety of the food supply. Another is revision of nutritional labels on food. To ensure a safe food supply, Kessler believes FDA will have to work more closely with state regulatory agencies that also have jurisdiction in this area. And the agency in the next two years will have revised food labels. While "coming to grips with food standards is a very high priority for the agency . . . [the effort] will require new approaches," Kessler says. Kessler came to the agency with a clear understanding of the magnitude of the task before him. And yet he was pleasantly surprised, he says, by how comfortable he is with the substance of the issues confronting him, and with the people who comprise FDA. Lois Ember
Energy policy debate runs gamut of issues Last month the Bush Administration made public its National Energy Strategy (NES), setting the stage in Congress for debate between conflicting ideologies. At one extreme are the fossil-energy-based free marketeers; at the other a coalition of environmentalist and energy conservation groups. While the extremes are easily definable, the issues are not really all that black and white. The oilhungry petrochemical industry, for example, needs low-priced feedstock to compete internationally. But it also has bowed to some degree toward environmental stewardship by steadily cutting emissions and improving efficiency. Still, there are those who believe that any U.S. industry that bases its success on lowpriced oil has its days numbered. Conservationists have become a powerful political force during the past decade as energy and environmental concerns have increasingly converged. Their energy policy agenda emphasizes legally enforced conservation and alternative power sources such as solar, biomass, wind, and any other types of power research uncovers. They are, of course, opposed to nuclear power because of its dangers and waste disposal problems. Consumers, meanwhile, appear to fall somewhere between the parsimony of environmentalism and selfindulgence of cheap oil. The Bush Administration knows this, and through its NES, believes the country can have it both ways. But its policy runs against stark numbers. U.S. crude and condensate production fell from 9 million barrels per day in 1985 to 7.4 million bbl per day last year. The projected production figure for 2005 is 5.6 million bbl per day. One who believes the Bush strategy is mostly a continuation of the Reagan policy is S. David Freeman, who produced the first energy policy package in 1971 for former President Nixon. Freeman, who also worked for former President Carter, later headed the Tennessee Valley Authority and is currently general
manager of the Sacramento Municipal District in California. Under Reagan, Freeman said in House hearings last month, "Conservation and renewables were flatout opposed. Funding for R&D was slashed. And just to make sure everyone got the point, [the Reagan Administration] even took down the solar collector on the White House roof that [former] President Carter had installed." The policy publicly declared by then Budget Director David Stockman was "strategic reserves and strategic forces." So the lines were formed for the current battle. Groups representing the free marketeers are the Chemical Manufacturers Association, American Petroleum Institute, U.S. Council for Energy Awareness (the nuclear power lobby), National Coal Association, American Gas Association, and various electric utility organizations. But because they all compete somewhat as energy sources, they don't agree on everything. Gas, for example, is touted as an ecologically compatible alternative transportation fuel; nuclear power as an antidote to the greenhouse effect. Among the conservation groups, the Natural Resources Defense Council is taking a leading role. Other groups are the World Resources Institute, Alliance To Save Energy, Greenpeace, Union of Con-
cerned Scientists, Sierra Club, Wilderness Society, Conservation Foundation, and Worldwatch Institute. Around 20 of these groups have coalesced into the Energy Conservation Coalition as a common front for the Congressional debate. Several issues make up the debate. The main ones are: • Corporate Average Fuel Efficiency (CAFE) standards. Conservation groups want federal efficiency standards for motor vehicles to rise to more than 40 miles per gal by around 2005. The private sector says the market should determine average fuel efficiency. The NES says promulgating lower CAFE would be tantamount to signing death warrants for thousands of Americans yearly. Part of the approach to making a car more fuel efficient consists of making it lighter and thus, says NES, more dangerous. • Alaskan National Wildlife Reserve, or ANWR. Industry, along with the Administration, wants to open up this north Alaska land to oil exploration and drilling. In fact, the NES bases its future oil production increases on ANWR (and offshore) reserves, which it believes are huge. But the U.S. Fish & Wildlife Service believes there is only a one-in-five chance that commercial quantities of oil exist in this area. The coalition opposes opening ANWR. The NES says production and preservation on ANWR are compatible in this day and age. • Taxes on the carbon content of fossil fuels, which are the main cause of global warming. The Bush Administration and the NES say no to new taxes on anything related to energy or anything else. Conservation groups say a stiff carbon tax— eventually $18 per ton of coal for example—would encourage industry to seek other forms of energy. • Gasoline tax. Not popular with anyone in industry. Still, most energy experts think gasoline is priced too low and because it is so low, development of other energy forms cannot be encouraged. Expect a lot of infighting over this. • Integrated resource planning for electric utilities. A complicated pricing issue, this would involve making energy conservation attracJohnston: offers "Made in America" act tive to utilities by not penalizing
them for encouraging it. California and New England are leading the way on this one. Other electrical utility changes are on the docket. • Increased nuclear power. This involves easing the licensing procedures for new plants, intensifying research on fail-safe units, and spending more money on solving the waste disposal problem. Add to these issues such items as tightening building codes for energy efficiency, ending gas pipeline leasing regulations, and subsidizing alternative fuels like ethanol and you have one big jungle to penetrate. Research and development issues also will highlight the debate. Critics say the NES is loaded with internal contradictions. For example, while the Department of Energy's R&D budget raises funding for solar energy, funding for clean-coal technology drops from $391 million to $315 million. Fossil energy R&D falls even more, from $460 million to $224 million. Energy supply and distribution research drops from $848 million to $540 million. The leading legislators to watch are obviously the chairmen of the energy committees in the House and Senate. The main player in the Senate is J. Bennett Johnston (D.-La.) of the Energy & Natural Resources Committee. On the House side it is Philip R. Sharp (D.-Ind.) of the House Energy & Commerce Committee. Johnston offers the most comprehensive bill of all—the National Energy Security Act (S. 341), which he also calls the "Made in America Act" because it aims to reduce dependence on foreign oil. Johnston is one of those who believes the costs of the Persian Gulf War should be factored into the price of oil. He also believes revenue from the leasing of ANWR rights should find its way into R&D on alternative energy sources. Being from an oil state, however, Johnston is for a strong production policy, which conservationists oppose. He also would open the outer Continental Shelf to production. Sharp has submitted five separate energy bills (H.R. 776-780) that together form a comprehensive package. His bills emphasize energy efficiency and renewable fuels; filling March 11, 1991 C&EN
23
Government the strategic petroleum reserve; streamlining regulatory rules for gas pipeline construction; and providing tax incentives for solar, wind, and geothermal sources as well as for energy and water conservation. Another important actor is Rep. Leo E. Panetta (D.-Calif.), chairman of the House Budget Committee. Panetta has submitted a conservation-oriented energy bill (H.R. 560) to counter what he calls Bush's "drain America first" policy. Panetta's bill would refill the strategic petroleum reserve from the current 570 million bbl to 2 billion bbl. It would set an oil floor price of $16 per bbl as a spur to conservation. His bill also would encourage oil production in Canada, Mexico, and Venezuela. And it would increase research funds on energy conservation, solar and renewable energy, enhanced oil recovery, and fuel cells. Rep. George E. Brown Jr. (D.Calif.), chairman of the House Science, Space & Technology Committee will be submitting a conservat i o n - m i n d e d e n e r g y R&D authorization bill. And obviously, the Administration will be submitting its own bill any day now. Most major Congressional bills require CAFE standards of up to 40 miles per gal by the first decade of the next century. They would increase import duties on crude oil and petroleum products and impose excise taxes on gasoline when its price falls below floor levels. A bill offered by Sen. Timothy E. Wirth (D.-Colo.) and 47 other Senators (S. 324) is geared toward reducing global warming gases by 20% by 2005 through measures running from reforestation to accelerated research on nuclear fusion. No one can be faulted for being confused over energy policy. Maybe the best way to reflect on it is to consider the remarks of Pennsylvania Lt. Gov. Mark S. Singel in House hearings last month. The NES's free market approach, he said, should also have included "a realization that the current prices for these supplies do not reflect fully environmental costs, energy security costs, or other external costs." By external costs he also meant wars. Wil Lepkowski 24
March 11, 1991 C&EN
Federal alert— new legislation This C&EN listing highlights legislation introduced between Jan. 22 and Feb. 28, 1991. House and Senate bills are listed under subject area by bill number, -primary sponsor, and committee(s) to which they were referred. HOUSE Energy. H.R. 612—Glickman (D.-Kan.). Requires new, stricter standards for corporate average fuel economy. Energy & Commerce. H.R. 657—Burton (R.-lnd.). Establishes Commission on Energy Independence. Energy & Commerce. H.R. 741—Mineta (D.-Calif.). Authorizes President to allocate supplies, limit prices of crude oil, refined petroleum products during times of severe shortages or threats thereof. Energy & Commerce. H.R. 776, 777, 780—Sharp (D.-lnd.). Require uniform testing, labeling of energysaving products; direct all federal agencies to do energy efficiency retrofits that have 10 year or less payback; provide tax incentives for renewable energy technologies, disincentives for employer-subsidized parking. Energy & Commerce. Ways & Means. Environment. H.R. 870—Torres (D.-Calif.). Provides management standards, recycling requirements for spent lead-acid batteries. Energy & Commerce. H.R. 1086—Stark (D.-Calif.). Imposes tax ranging from $3.60 per ton to 78 cents per barrel on carbon content of fossil fuels. Ways & Means. Taxes. H.R. 682—Hunter (R.-Calif.). Imposes minimum tax of 5% of gross income on foreign and foreign-owned corporations that do not provide sufficient information to accurately determine their taxable income. Ways & Means. Waste. H.R. 607—Erdreich (D.-Ala.). Grants states authority to regulate interstate disposal of hazardous and solid waste. Energy & Commerce. H.R. 816—Owens (D.-Utah). Authorizes each state to prohibit importation of hazardous waste into state for treatment or disposal. Energy & Commerce. H.R. 828—Slaughter (D.-N.Y.). Authorizes federal grants for development of innovative recycling techniques. Energy & Commerce. H.R. 921—Richardson (D.-N.M.). Prohibits disposal of solid waste in any state other than state in which waste was generated. Energy & Commerce. SENATE Competitiveness. S. 479—Leahy (D.-Vt.). Allows companies to form joint production, in addition to joint research, ventures to exploit new technologies. Judiciary. Computing. S. 272—Gore (D.-Tenn.). Authorizes spending just under $1 billion over
five years to establish national research and education computer network. Commerce, Science & Transportation. S. 343—Johnston (D.-La.). Directs Department of Energy to establish national multigigabit-per-second computer network. Energy & Natural Resources. Education. H.R. 775—Stokes (D.-Ohio). Directs NSF to provide grants for establishment of at least 20 summer science academies for training talented economically disadvantaged minority students and women in math, sciences, engineering. Science, Space & Technology. Education & Labor. Energy. S. 279—Bryan (D.-Nev.). Requires automakers to improve corporate average fuel efficiency 40% by 2005. Commerce, Science & Transportation. S. 324—Wirth (D.-Colo.). Directs Department of Energy to develop low-cost strategies for reducing U.S. carbon dioxide emissions 20% by 2005, provides incentives for industrial energy conservation, use of natural gas. Energy & Natural Resources. S. 341—Johnston (D.-La.). Omnibus energy bill allows limited leasing of Alaska coastal sections for oil and gas development, provides incentives for commercialization of advanced nuclear reactor technologies and for energy conservation, promotes research on coal. Energy & Natural Resources. Indoor air. S. 455—Mitchell (D.-Me.). Establishes comprehensive research program for indoor air quality, grant program for development of indoor air control technologies; requires development of advisories to assess health risks posed by specific indoor air contaminants at range of concentrations. Environment & Public Works. Taxes. S. 340—Metzenbaum (D.-Ohio). Imposes excess profits surtax on large foreign, domestic oil companies doing business in U.S. Finance. Trade. S. 320—Riegle (D.-Mich.). Institutes new controls on exports of goods that could assist renegade governments to develop, deliver chemical and biological weapons. Placed on calendar. Workpiace. S. 353—Jeffords (R.-Vt). Requires National Institute for Occupational Safety & Health to study prevalence of contamination of workers' homes with hazardous chemicals transported from their workplaces, suggests regulations to prevent or mitigate contamination. Labor & Human Resources. S. 445—Metzenbaum (D.-Ohio). Increases from six months to 10 years penalty for willful violation of OSHA rules that results in death, creates new criminal sanction for willful violation that results in serious bodily injury. Labor & Human Resources. Waste. S. 241—Warner (R.-Va.). Initially allows states to set higher fees for disposal of out-of-state trash, gives states with effective waste management plans authority to ban waste imports. Environment & Public Works.
