FDA needn't regulate unavoidable additives In an 8-to-l decision, the U.S. Supreme Court has agreed with the Food & Drug Administration, saying the agency does not have to go through a formal rule-making procedure to set action levels for hazardous substances that unavoidably get into food. Justice John Paul Stevens wrote the only dissenting opinion. The suit, originally filed in 1980, comes down to a semantic interpretation of a section of the Food, Drug & Cosmetic Act. With regard to unavoidable substances getting into food, the law states that the FDA commissioner "shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of human health." FDA has said that the words "to such extent" modify the word shall, roughly meaning that the commissioner can set some regulatory action level as he sees fit. The lawsuit, filed by the Community Nutrition Institute and Public Citizen over a notice that changed the level of aflatoxin permitted in some corn, contends that
"shall" is modified by the words "the quantity therein and thereon." This interpretation, roughly, would force the commissioner to set formal tolerance levels for any substance that gets into food. In agreeing with FDA, Justice Sandra Day O'Connor writes: "In the light of the inherent ambiguity, FDA's interpretation of the provision is sufficiently rational to preclude a court from substituting its judgment for that of FDA." She says Congress apparently intended the commissioner to have discretionary authority with regard to unavoidable food contaminants. In dissenting, Justice Stevens, who along with the Court of Appeals agreed with the principle of the lawsuit, writes that the law means that the addition of substances that cannot be avoided should trigger FDA's obligation to initiate rule making. He finds the wording in the passage unambiguous and that the Supreme Court has abrogated some of its responsibility by merely following the regulatory agency's point of view. D
to enjoy continued strong growth. He adds, "Biotechnology laboratories are in an explosive growth mode because of genetic engineering expenditures." He believes the new group is well positioned to serve that market. D
OSHA reduces allowed asbestos exposure New rules issued by the Occupational Safety & Health Administration have cut the amount of asbestos allowed in the workplace to 10% of what has been permissible under the old standard. The agency estimates the new regulations will significantly reduce 1.3 million U.S. workers' risk of contracting asbestosis or cancer from exposure to the fibrous mineral on the job. OSHA wrote two separate regulations—one covering general industry and one specifically for construction—instead of a single rule covering all industries as it has done in the past. Construction workers are often heavily exposed to asbestos during building renovations, and the separate rule for that industry contains monitoring and other pro-
Henley Group forms medical/scientific company Henley Group, the agglomeration of business units spun off from Allied-Signal, has formed a billiondollar medical and scientific technologies company centered on Fisher Scientific. Eventually, the new unit itself may be spun off from Henley into a public company. Called Fisher Scientific Group, based in La Jolla, Calif., the new unit includes lab products maker Fisher Scientific, headquartered in Pittsburgh; medical and scientific instruments producer Instrumentation Laboratory, of Lexington, Mass.; and IMED, of San Diego, Calif., a developer of infusion systems for regulation and control of intravenous solutions administered to hospital patients. Henley recently completed the purchase of IMED from Warner-Lambert. In addition, Henley says it has acquired a "significant position" in Barrett Laboratories, Sacramento, a designer of electronic information
management systems for clinical laboratories in hospitals. Combined annual sales of the new Fisher Scientific Group are near $1 billion. The group has about 7600 employees. Michael D. Dingman, Henley's chairman and chief executive officer, says, "The group will serve the biotechnology, medical, and scientific laboratory markets currently supplied by the operating companies and, equally important, will provide access to these markets for the products of other firms we plan to acquire. The companies of Fisher Scientific, and the businesses that will be added to it, are expected to be a source of significant growth in earnings and shareholder value. The group could ultimately become a public company in its own right." Richard A. Cramer, a Henley director and cofounder of IMED, will head the group. Cramer says the group's major markets are expected
Worker bandling asbestos would be covered by new OSHA rule June 23, 1986 C&EN
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News of the Week visions meant to protect workers under unique circumstances. In both regulations, the new exposure limit is 0.2 fiber per cc of air averaged over an eight-hour day, reduced from the maximum allowed level of 2 fibers per cc that has been in effect since 1972. OSHA first proposed lowering the standard in 1975. "We're happy to see an effort begun in the Ford Administration finally come out in the second Reagan Administration," says Sheldon W. Samuels, director of health, safety, and environment for the industrial union department of the AFL-CIO. However, the union is concerned that the new regulations lack a short-term exposure limit and is considering challenging them, Samuels says. The Asbestos Information Association, an organization of U.S. and Canadian asbestos mining, milling, and manufacturing firms, already has petitioned the Fifth U.S. Circuit Court of Appeals to review the regulations, according to spokesman Kenneth E. Nyquist. The association doubts it is technically feasible to monitor airborne asbestos at the low levels required by the new rules. The effect of the new OSHA regulations on the Environmental Protection Agency's proposed ban of asbestos (C&EN, Jan. 27, page 6) is not clear. EPA Administrator Lee M. Thomas said last week that his agency will continue drafting the ban. OSHA estimates that complying with the new workplace standards will cost industry $460 million a year. The rules will take effect 30 days after publication in the Federal Register, which was expected last week» D
Labs for research at ultralow temperatures Developments in ultralow-temperature research in the U.S. are heating up, thanks in large part to the National Science Foundation. NSF has just awarded the University of Florida a four-year, $1.3 million grant to set up a laboratory where researchers can study matter at tem8
June 23, 1986 C&EN
peratures a few millionths of a degree above absolute zero. And at Cornell University last week, a similar NSF-funded "microkelvin laboratory" was formally opened with a ribbon-cutting ceremony. The NSF awards to Cornell and Florida promise to keep the two institutions in the forefront of ultralow-temperature research in the U.S. The research programs planned by the two laboratories "are complementary with some desirable overlap," according to the foundation. Researchers at Cornell's $1.5 million underground facility will focus on basic properties of simple metals, insulators, and semiconductors to better understand how electronic behavior changes as those materials are cooled to temperatures several microkelvins above absolute zero. The Florida researchers will concentrate on the behavior and properties of liquid and solid he-
lium-3 and on superconductivity in metals. The ultralow temperatures required at the facilities—much lower than even deep space provides— are achieved using a helium dilution refrigerator coupled with two stages of nuclear demagnetization. Because vibrations produce heat, the cooling chambers are installed in vibration-isolated buildings in electromagnetically shielded, low-noise rooms. Construction of Florida's microkelvin lab is expected to begin in January 1987, says physicist E. Dwight Adams, one of the project's leaders. The state of Florida has contributed $450,000 for the construction, he notes. When the facility is completed later that year, it will join what is only a handful of centers around the world capable of studying matter at such ultralow temperatures. D
Caltech to have new biology/chemistry institute A new institute to "attack problems at the interface between biology and chemistry" will be set up at California Institute of Technology, thanks to a gift of $50 million from the Arnold and Mabel Beckman Foundation. The Beckman Institute "will provide Caltech faculty members with a rapid and flexible means of obtaining research funds for particularly creative and innovative projects that might otherwise not be supported," explains Ruben F. Mettler, chairman of the Caltech board of trustees. " I n the past, some of Caltech's most significant research achievements have depended on just such funding sources." Some research areas that the institute might support include chemical synthesis of n e w polymers, development of advanced genetic engineering concepts and instrumentation, preparation and testing of new types of catalytic and ceramic materials, and development of computer and instrumentation techniques for protein engineering and human chromosomal mapping. The institute eventually will be housed in a new building on campus, which will have, in addition to
research facilities for i n s t i t u t e sponsored projects, major research instrumentation that will be available to the entire Caltech community. The Beckman grant, which is the largest single gift the foundation has ever made, comes in two parts: an initial $40 million, which is contingent on the school's raising $10 million in capital funds from private sources, and an additional $10 million if Caltech raises an equal amount for the institute's general endowment from the members of its board of trustees. Arnold O. Beckman, who heads the Beckman Foundation, is founder and chairman of Beckman Instruments. He is a Caltech alumnus, served on the school's faculty for 12 years, and was chairman of its board of trustees for 10 years until 1974 when he became chairman emeritus. "It has long been my belief that science and higher education should not depend exclusively on governmental sources of support," Beckman says. "Mrs. Beckman and I have strong sentimental attachments to Caltech, and we are certain that the Beckman Institute could not have found a more suitable home." D
