News of the Week
Texas Eastern to move MTBE by pipeline Texas Eastern Products Pipeline Co. (TEPPCO) is poised to become "the first products pipeline [company] in the nation to continuously move and store significant quantities" of methyl tert-butyl ether (MTBE). Aiming to supply soaring demand for the gasoline additive, TEPPCO has begun to modify its existing system to enable it to store increasing quantities of MTBE, and to transport it by pipeline from the Gulf Coast to the Midwest. When used as an octane enhancer, MTBE allows more complete combustion of gasoline in car engines, thereby reducing emissions to levels r e q u i r e d by the Clean Air Act amendments passed last year. As refiners and manufacturers gear up to produce reformulated gasolines to meet these new regulations, MTBE supplies will "be tight throughout most of this d e c a d e , " p r e d i c t s Charles L. McSpadden, a consultant with Bonner & Moore Associates in Houston. That's true, he adds, despite the flurry of new MTBE plant a n n o u n c e m e n t s (C&EN, May 6, page 21). "Pipeline transfer, which is one of the most efficient means of MTBE transport, will play a major role as regional demand begins to exceed a region's supply, and the availability of efficient and cost-effective logistics becomes the limiting factor in its usage," says TEPPCO vice president David L. Langley. McSpadden notes that pipeline transport is much cheaper and involves less lead time than barge or rail transportation, especially when shipping from the Gulf Coast supplying region to the high-demand Midwest and Atlantic Coast regions. Other companies, such as Colonial Pipeline (Atlanta), already transport gasolines that contain MTBE. But TEPPCO claims to be the first to do so with MTBE alone. TEPPCO's pipeline system initially will transport 40,000 to 50,000 barrels per month, a capacity that the company plans to increase steadily during 1991, says its president, Michael D. Burke. By mid-June, the company will 6
May 20, 1991 C&EN
have converted some 100,000 barrels of storage capacity at its Beaumont marine and pipeline terminals to accommodate MTBE. That capacity could grow to 800,000 barrels by the end of 1991, and 1.5 million barrels following subsequent conversions. Susan Ainsworth
Advisory panel calls for major reforms at FDA The Food & Drug Administration is l i v i n g on b o r r o w e d t i m e . The chronic and pervasive shortcomings with which FDA has had to cope for more than a decade have seriously crippled it. An agency charged with such a broad array of vital health protection responsibilities, yet an agency lacking the tools to carry out those responsibilities, is in serious danger. That is the somber assessment presented to the Senate Committee on Labor & Human Resources last week by Charles C. Edwards, chairman of the Scripps Clinic and Research Foundation and former FDA commissioner. Edwards chaired a 16-member advisory panel convened by Secretary of Health & Human Services Louis W. Sullivan in March last year to review FDA's mission, structure, priorities, staffing, and budget. Edwards chose to highlight at the hearing "two major underlying issues that, in my judgment, account for the severe problems we see at FDA today." First, he says, is a chronic lack of leadership at all levels within FDA. By leadership he means not just the ability to guide and manage a large, complex organization, but also the ability to organize and direct people and programs at the cutting edge of technology. Edwards makes it clear that he is not speaking about David A. Kessler (C&EN, March 11, page 21), whose recent appointment as FDA Commissioner "is a most encouraging change." The second issue is the placement and status of FDA in the federal bureaucracy. Edwards points out that FDA is buried three layers deep in an HHS organization that has no institutional sympathy for regulatory,
law-enforcement functions, and that in the past has been less than fully supportive of the agency's needs. To alleviate these problems, the panel decided that FDA must be separated from the Public Health Service (PHS), and must become a top-level operating agency within HHS. The Commissioner, it says, must be armed with full authority for independent action commensurate with his responsibilities. He must report solely and directly to the Secretary, and have the authority to run the agency's operations, including regulations, facilities, equipment, and personnel. If that is unacceptable to HHS or the White House, Congress should enact legislation to reconstitute FDA as a free-standing agency, Edwards told the Senate committee. That suggestion didn't find favor with Sullivan. He believes that the strongest FDA is one that remains part of PHS, allowing FDA scientists to continue to interact closely with scientists from other PHS agencies, such as the National Institutes of Health and Centers for Disease Control. However, Sullivan does strongly support a number of other panel recommendations. He agrees that FDA should clearly define its missions and develop a formal statement of purpose. He recognizes the need to develop sophisticated computerized data capability at FDA. And he agrees that FDA needs to develop clear and precise regulatory guidance to foster voluntary compliance and set priorities for its enforcement activities. Labor & Human Services Committee chairman Edward M. Kennedy (D.-Mass.) endorsed the advisory committee's overall conclusion that increased efficiency, better planning, and stronger management could help stretch existing resources to do more. But, he said, "there are obvious limits: one inspector cannot be in 10 cities on the same day; if the lab equipment is 30 years out of date, certain state-of-the-art experiments cannot be carried out." It is time, he concluded, for Congress and the Administration to reach agreement on adequate appropriations for FDA. Janice Long
