RADIOACTIVITY IN FOOD AND DRUGS Senator MONRONEY. Could I ask, while he is interrupted, about this effect of radioactivity on foods and drugs? Do you get any help from the Atomic Energy Commission? We have committees now that include collaboration with the Public Health Service and the Atomic Energy Commission. The medical group in the Atomic Energy Commission works very closely with our people. We are very well satisfied. Senator HILL. In other words, this would not duplicate any of the work they do; it merely puts into gear the effectiveness of all of this other study; is that right? Mr. LARRICK. That is right. The Food and Drug Administration is primarily responsible for the safety of our food supply. We would take everything that they find out and use it and find out some more things ourselves to be sure that, as the radioactivity becomes more and more a part of the industrial life of this country, it does not contaminate the food supply. Another interesting project that we would undertake would be a project to develop methods of analysis for adrenal and cortes hormones. These are drugs that are truly marvelous, but our methods of analysis to determine just how potent they are leaves a lot to be desired, and again this is very complex chemistry. MEDICAL ACTIVITIES Over $145,000 would be used to improve our medical programs, including five new positions to work on the processing of new drug applications, as you know FDA is required to approve every new drug marketed in this country. Senator MONRONEY. May I ask one question there? I hear over television all kinds of new drugs, including pills that will slenderize fat Senators and ladies that are too plump. Does that come under the category of drugs? Mr. LARRICK. Yes, but the advertising is subject to the Federal Trade Commission Act, as I recall. Senator MONRONEY. Yes. You check to see that they are not deleterious to the person or the individual, and they cannot be marketed if your findings are that these patent medicines that are supposed to work miracles on fat people are something that would have a long-range harmful effect to the body? Mr. LARRICK. They have to prove to our satisfaction that they are safe before they can put them on the market, and that applies to the drugs that the doctor uses as well as proprietary medicines. PATENT MEDICINE Senator MONRONEY. Of course, with the advertising trade seeming to stimulate more and more patent medicines, it seems like there is a wide new variety coming into being almost with every new television show. Mr. LARRICK. Fortunately, they rarely try to treat the really serious disease. You don't see them for cancer, TB, diabetes, but you certainly see a lot for lesser conditions. NEW PERSONNEL These medical activities would include five new positions to work on the processing of these new drug applications and three additional positions and sufficient funds to establish a system, in collaboration with participating hospitals, to identify unanticipated adverse reactions to new drugs after they have gone on the market. Four new jobs would be added to study quack drugs and devices, including funds for clinical studies of such products. Increases in this area should produce new evidence to support court actions against other than just the most flagrant violations. EDUCATIONAL, REGULATORY, AND ADMINISTRATIVE ACTIVITIES We would expand our educational, regulatory, and administrative activities. The remainder of the increase, approximately $168,000, would be used to improve our educational, regulatory, and administrative activities. A total of 22 jobs would be added to these areas. I overlooked one research project, to study the presence of toxic properties in reheated fats. That concludes my summation of my testimony. Senator HILL. Can you give us an illustration of that last one, the reheating of fats? PROBLEM OF FATS Mr. LARRICK. As more and more of our foods are produced in the factory, the fat that is used to make all manner of fried foods is used over and over and over again, and there have been some pretty serious charges made that, under very special conditions, these fats that are heated over and over and over again can produce some byproducts in the fat that may be toxic. We want to make a broad study of this and find out just what the conditions are that make these toxic substances form, and then rule it out. This matter came to our attention in a very emphatic way when a firm in Cincinnati took some fat that they had recovered from various places and gave it a special heat treatment and put it in chicken feed and killed millions of chickens. This incident brought very dramatically to our attention the fact that we should look into this matter. STATUS OF BUILDING Senator HILL. Mr. Larrick, the Food and Drug Administration made an attempt to get a building here in the District, not only to Lone its administrative officers, but also for its laboratories. They made that attempt under the old lease-purchase program. What is the status of that building now? Mr. LARRICK. Money was appropriated, Senator, to do the architectural work and that is progressing nicely. Money was appropriated 41001—55- -14 to buy the site and to tear down the old buildings. That is accomplished, but no money has been provided to proceed with the building itself. Senator HILL. Are your plans all completed? Mr. LARRICK. They are in the process of completing them. They will be completed this fiscal year. Senator HILL. You mean this present fiscal year, 1959? Mr. LARRICK. Yes. Senator HILL. In other words, they will be complete by July 1? Senator HILL. What do you estimate the cost of that building to be? Mr. LARRICK. $23 million. It is a very highly specialized, fine laboratory building. We are now in four different locations, and our laboratories, located in the Department of Agriculture Building, are very much out of date. Senator HILL. And you are so scattered? Mr. LARRICK. That is right, with four different locations. Senator HILL. However, there is no budget estimate for that in the budgets of next year? Mr. LARRICK. No, sir; there is no building provided for. Senator HILL. However, your plans will be ready by July 1? Mr. LARRICK. That is right. Senator MONRONEY. Are these four buildings all Government buildings, or are some of them private? Mr. LARRICK. No. They are all Government buildings. One of them is temporary, one is over in the former Providence Hospital nurses building, part of it in the South Agriculture Building, and the rest of it is in the Health, Education, and Welfare Building. RECOMMENDATIONS OF ADVISORY COMMITTEE Senator HILL. Mr. Larrick, several years ago you had for study some important recommendations from your Citizens Advisory Committee. How long has that been? Mr. LARRICK. That has been 4 years ago. Senator HILL. How have you done so far as your progress with reference to the recommendations made by that committee? Mr. LARRICK. This group of very distinguished people, including folks from industry, representatives from women's organizations, and others, recommended that the Food and Drug Administration grow from threefold to fourfold within a period of 5 to 10 years. The plan was to adopt the minimum amount of that growth, and here is a chart that shows what has happened. Senator HILL. You do not have extra copies of that chart? Mr. LARRICK. Yes; we do have. We will be glad to put that in the record. Actually, we are behind the minimum the committee recommended right now. (The information referred to follows:) NUMBER OF PERSONNEL 3500 PROGRESS IN F. D. A. PERSONNEL EXPANSION COMMITTEE 3545 1763 1533 1333 1159 1008 Base at the time the Projected Expansion Rate 3083 FDA-PPA 1-59 1965 1 1956 1957 1958 1959 1960 1961 1962 1963 1964 1965 1966 FISCAL YEAR The projection shows increases necessary to meet the expansion recommended by the Citizens Advisory Committee in the maximum time period (10 years). Shaded columns indicate staff for activities on enforcement programs operating in 1956. LAG IN APPLYING RECOMMENDATIONS Senator HILL. How much behind are you? Mr. LARRICK. Quite substantially behind. Mr. CARDWELL. For example, in fiscal year 1959, the recommendations of the Citizens Advisory Committee, on the basis of that growth factor which would bring about a fourfold increase at the end of the period, would have required approximately 1,333 employees. The regular budget for 1959, exclusive of the food additives program, provides 1,251 positions. Mr. LARRICK. So we are about 80 positions behind as of 1959. We would fall farther behind with the present budget, but would almost come up to the minimum with the House action. Mr. CARDWELL. The House action would bring us up to the minimum. Senator HILL. I wonder with the changes we have seen in the last 4 or 5 years if that committee made certain recommendations today whether their recommendations would be different from those at the time they made their report. Mr. LARRICK. I think they would. I think they would be higher. Senator HILL. Have you given any thought to further study by the committee? Mr. LARRICK. Yes. I think that the time has about arrived when we should either reenact that committee or perhaps a new one to look into this. Senator HILL. To study this whole field? Mr. LARRICK. The broad, fast-changing field of food and drug technology. COST OF STUDY Senator HILL. How much did that study cost? Do you recall, Mr. Larrick? Mr. LARRICK. It was of the order of $25,000. Mr. HARVEY. I think it was about $30,000. Mr. LARRICK. $25,000 to $30,000. We will be glad to supply the exact figure. Senator HILL. All right; you may insert that. (The information referred to follows:) Costs in connection with the study made by the Citizens Advisory Committee were approximately $23,450. Mr. LARRICK. It was an appropriation from Congress. CONTAMINATED EGGS Senator MONRONEY. Among the cases that I believe the Food and Drug Administration took action on was the powdering of contaminated eggs which you suspected were finding their way into bakery products and other things. Do you feel you have successfully stopped that? Mr. LARRICK. No. That is a terrifically lucrative business. You can go around to all these incubator places where they hatch eggs by the millions and buy up the infertile eggs that hadn't hatched for 7 cents a dozen, freeze them into big cans, and sell them for a fancy price. They are hard to stop. We are in the process of bringing a number of them into court, but it is so lucrative for the unscrupulous operator that I am afraid we are |