Chicago Mercantile Exchange......Live Cattle, Live Hogs, Frozen Pork Bellies, Lumber, Live Feeder Cattle, leaded Regular International Monetary. .British Pound, Canadian Dollar, Deutsche Commodity Exchange, Inc..........copper, Silver, Gold, Aluminum Kansas City Board of Trade.. Wheat, Value Line Index, Mini Value Line MidAmerica Commodity Exchange....Wheat, com, Oats, Soybeans, Silver, Live Hogs, Live Cattle, Gold (33.2 ounces), Citrus Associates of the.........Frozen Concentrated Orange Juice Petroleum Associates of the......Propane New York Mercantile Exchange.... Round White Potatoes (old), Platinum, Palladium, No. 2 Heating Oil (New York), New York Futures Exchange. .NYSE Composite Index Chicago Rice and Cotton. .. Rough Rice Options Traded on Markets Designated by CFTC 21 Chicago Board of Trade....... ...U.S. Treasury Bonds coffee, Sugar and Cocoa Exchange....... Sugar #11 Cammodity Exchange, Inc.... ..Gold Chicago Mercantile Exchange. .S&P 500 Stock Index, Deutsche Mark New York Futures Exchange.. .NYSE Composite Stock Index MidAmerica commodity Exchange. . Gold Fiscal year 1984 is the period October 1, 1983 through September 30, 1984. Traded during 1984. ESTE ATED AVERAGE MONTHEND OPEN INTEREST, VOLUME OF FUTURES TRADING AND TOTAL DELIVERIES, Contract Open Interest Commodits Unit 1983-84 1982-83 (contracts) Wheat 5,000 bushels 80,477 73,177 Com 5,000 bushels 184,961 166,606 Cats 5,000 bushels 4,854 7,752 Rice 17 27 270 37 782 So beans 5,000 bushels 94,134 102,080 Sobcan Meal 100 tons 58,103 49,622 Soybean Oil 60,000 pounds 59,172 35,638 Cotton 50,000 pounds 27,498 31,687 Potatoes 50,000 pounds 543 852 Potatoes 47 100,000 pounds 1,496 2,467 Frozer: Concentrated Orange Juice 15,000 pounds 9,858 6,912 Cattle 57 6 55,652 60,764 Live Hogs 77 32,669 41,608 Frozen Pork Bellics 38,000 pounds 15,965 16,778 Broilers 30,000 pounds 0 10 Silver 8/ 5,000 troy ounces 70,083 53,035 Cold 9/ 100 troy ounces 138,180 124,720 corper 25,000 pounds 96,129 103,335 Aluminum 10/ 40,000 pounds 2,838 Platinum 50 troy ounces 14,762 16,749 Palladium 100 troy ounces 7,247 6,979 Sugar 112,000 pounds 97,271 84,186 Cocoa 10 metric tons 25,896 24,703 Coffee 37,500 pounds 9,977 9,805 Heating Oil 1,000 barrels 24,561 26,901 Fuel Oil No. 2 11/ 42,000 gallons 164 Lumber 130,000 board feet 7,883 9,500 Plywood 76,032 square feet 364 1,844 Propane 100,000 gallons 1,093 1,009 Gasoline 1,000 barrels 15,184 11,207 Crude Oil 1,000 barrels 26,365 7,218 GAMA Mortgages $100,000 prin. bal. 31,902 43,052 T-Bills (90 Day) $1,000,000 48,122 45,283 T-Bonds $100,000 181,703 155,864 A II 127 $100,000 1,981 T-Notes (2 Year) $100,000 0 101 T-Notes (6) - 10 Year) $100,000 24,975 8,860 Domestic CD (90 Day) $1,000,000 27,794 15,048 Eurodollar $1,000,000 68,802 24,437 Value Line Index $500 X Index 3,854 3,546 Mini Value Line Index $100 X Index 691 1,772 MYSC Camposite Index $500 X Index 9,310 8,439 NYSE Financial Index $1,000 X Index 0 53 S&P 500 Stock Index $500 X Index 3,803 556 0 76,102 103,837 59,486 4,688 11,525 1,525 8,600 4,302 1,580 12,680 130 332 615 1,482 12,695 11,924 14,907 6,184 63,315 1, 339 0 9,982 3,894 13,846 1,970 2,295 9,710 711.8 28.3 201.0 1,857.2 4,335.0 19,229.4 819 3,892 1,414 7534 666 11,847 8,480 40,271 0.6 75 31,381 21,755 S&P 100 Stock Index $100 X Index 2,776 3,493 Major llarket Index 137 $100 X Index 6,293 Foreign Currencies 14/ 112,132 118,669 11,059.2 7,553.9 43,080 47 24,638 41 10,433 4/ 2,456 47 365.7 187.5 663.1 13,596.1 11,398.1 0 105,114 66,065 TOTAL 1,715,365 1,547,446 144,903,2 132,023.2 1,175,020 767,592 1/ Includes milled rice and rough rice. 20,000 pounds, MidAmerica Conmodity exchange. Live feeder cattle contracts of 42,000 pounds. 15,000 pounds. B/ Chicago Board of Trade contracts of both 5,000 and 1,000 troy ances. Commodity Exchange, Inc., contracts of 5,000 troy ounces. MidAmerica Cannodity Bacchange contracts of 1,000 troy amoes. 91 Camodity Exchange, Inc., and Chicago Board of Trade contracts of 100 troy ances. Midhmerica Connodity Ecchange contracts of 33.2 troy ounces. 10/ Trading began December 8, 1983. 11/ Trading began March 26, 1984. 1/ Trading began March 22, 1984. 15/ Trading began July 23, 1984. TUESDAY, MARCH 26, 1985. FOOD AND DRUG ADMINISTRATION WITNESSES FRANK E. YOUNG, M.D., PH.D., COMMISSIONER OF FOOD AND DRUGS OPERATIONS NARY MEDICINE MARION FINKEL, M.D., DIRECTOR, OFFICE OF ORPHAN PRODUCTS DEVELOPMENT RICHARD RONK, DEPUTY DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN) ALLEN FORBES, M.D., DIRECTOR, OFFICE OF NUTRITION AND FOOD SCIENCE, CFSAN Mr. WHITTEN. The Committee will come to order. At this time we have with us Dr. Young, Commissioner of Food and Drugs, and his associates. We are glad to have you with us and those who may be new we will be glad to have a biographical sketch included in the record. (CLERK's Note. - The biographical sketch follows. The full text of Dr. Young's statement appears on pages 626 through 640. The explanatory notes appear on pages 641 through 846.) BACKGROUND INFORMATION ON DR. FRANK E. YOUNG The new FDA Commissioner, Dr. Frank E. Young, 52, M.D., Ph.D., is a pathologist, a microbiologist, an educator and a researcher in fundamental genetic techniques. He comes to the Agency from the University of Rochester, New York, where he was Chairman of the Department of Microbiology (1970-79), Dean of the School of Medicine and Dentistry (1979-84), Director of the Medical Center (1979-81) and Vice President for Health Affairs (1981-84). At Rochester he was professor of Microbiology, of Pathology and of Radiation Biology and Biophysics. His clinical responsibilities included Director of the Clinical Microbiology Laboratories, Strong Memorial Hospital (1970–79), Microbiologist in Chief, Strong Memorial Hospital (1976–79), Pathologist, Strong Memorial Hospital (1970-84). While Dean, he also developed a laboratory for biotechnology research to work on the cloning of genes and development of vaccines. He has published over 150 scientific articles on his research and has participated in government deliberations on genetic engineering. He was an editor of the journal Gene from 1976 to 1983, and served on the editorial boards of the Journal of Bacteriology, the Journal of Applied Biochemistry and Reviews in Infectious Disease. Before going to the University of Rochester in 1970, he was assistant professor of Pathology at Western Reserve University in Cleveland, Ohio and later associate professor and the professor in the departments of microbiology and experimental pathology at the Scripps Clinic and Research Foundation, La Jolla, California. (265) Dr. Young attended Union College in Schenectady, New York. He received an M.D. degree cum laude from the University of the State of New York, Upstate Medical Center, Syracuse, in 1956 and a Ph.D. from Western Reserve University in 1962. In 1956, Dr. Young began his internship at University Hospitals of Western Re serve University and completed his residency there in pathology in 1960. He is a member of ten scientific societies including the Institute of Medicine of the National Academy of Science and was awarded an honorary doctor of science degrees from Roberts Wesleyan College, Rochester, 1983 and from Houghton College in Houghton, New York 1984. Dr. Young has served on more than 24 hospital and medical center committees, the Doctoral Review Council of the State of New York in New York, and delivered many invited lectures at national and international conferences. Dr. Young has served on NIH advisory committees, including the Recombinant DNA Advisory Committee (1979–80), Microbiology Training Study Section (1972–73), the Bacteriology and Mycology Study Section (1975–79), and was chairman of the Microbial Genetics Study Section (1981-82). He also was a member of the Scientific Advisory Committee for Virology and Cell Biology Study Section of the American Cancer Society (1974-79). Mr. WHITTEN. We will be glad to have you proceed, Dr. Young. You can introduce yourself and the others. Your prepared state ment will appear in the record, but you might touch on the high spots if you prefer to do it that way. Dr. YOUNG. Thank you very much. I would like to introduce Dr. Mason, who is the Acting Assistant Secretary for Health. On my right is Tom Scarlett, who is our General Counsel. Mr. Meyer, who is our person dealing with budgets. Mr. WHITTEN. He is your anchor man, isn't he? Dr. YOUNG. He is. He does an exceptionally fine job and this younger fellow that he brought along with him, Frank Claunts, who put a large amount of the testimony together. And, sir, if Dr. Mason can just make his remarks I would continue from there. Mr. WHITTEN. I'll be glad to have you proceed. DR. MASON'S STATEMENT Dr. Mason. Chairman Whitten, I am delighted to have this opportunity to be here today. It's a pleasure to accompany Dr. Young and his staff and to be here in support of FDA's budget request. The Public Health Service, as you know, is committed to the achievement of better health for our nation's people through such things as disease prevention, health promotion and the maintenance of a strong research capability. FDA's primary goal is to protect and promote the public health through the effective use and enforcement of its authority. It must rely upon a firm scientific foundation. We are very fortunate in having Commissioner Young's leadership and excellent expertise. At this time, Mr. Chairman, I would be pleased if you would recognize him to present the FDA opening statement. Mr. WHITTEN. Dr. Young. DR. YOUNG'S STATEMENT Dr. YOUNG. Mr. Chairman, I will just summarize very briefly in view of your heavy schedule. I would first like to emphasize that I am particularly pleased to be at the hearing because of my firm commitment and the agency's commitment to move even closer and collaborate even closer than we have in the past with the Department of Agriculture. COLLABORATION WITH USDA We would like to stress that we already do collaborate with USDA on a wide variety of issues including the recent work that we did with biotechnology and we were very close in our relationship on those guidelines. We are also developing a collaborative program on something that is akin to your leadership effort on orphan drugs, and these are drugs for minor species of animals. And I have mentioned in my testimony one of the areas that we were particularly interested in and that is dealing with aquaculture. One of the concerns we have in the growing increase in food production through fish is the need to develop antibiotic and other drugs that can be useful in the farming of fish. Minor species such as trout, catfish and others are being grown in ever larger amounts, particularly in the state that you come from, as you know, with the catfish industry there. In the past we have focused much of our effort on drugs that are used for the major species and not developed that particular emphasis on minor species, which is akin to the orphan drug problem. And I have introduced for the record a letter from the Delta Council that speaks to this effort of a collaborative study between Auburn, Mississippi State, LSU and the University of Illinois in an attempt to determine how we can deal with those minor species. The focus is to develop the safe and effective antibiotics and other medicinals that will enable fish to be grown in close quarters and to be used for food. AFLATOXIN A second area of importance in our interrelationship to Agriculture is a focus on aflatoxin, a naturally occurring carcinogenic substance in cottonseed meal. We wish to undertake a study with regard to the ammoniation process which detoxifies this cottonseed meal from aflatoxin, and we feel that this would be very important for the American farm industry as it would enable cottonseed meal which is not able to be used today to be used for feed for cattle. This would take a substantial amount of research and again focus our collaboration between Agriculture and FDA. ORPHAN PRODUCTS I have mentioned drugs for minor species only as an example of another emerging orphan category of future concern. Now I would like to talk about the FDA accomplishments and plans in implementing the Orphan Drug Act of 1983 in the area of human drugs. Frank, if you would please put up the chart. I would like to summarize for your interest the growing development that we have had since the legislation has come into place and in large measure under your leadership. [The chart follows:] |