We are in consultation with the State and they are making modifications of the plan which will make it approvable. Mr. STAGGERS. You expect to have that one? Dr. YOLLES. Yes, we do. Mr. STAGGERS. That is all, Mr. Chairman. Thank you. Mr. JARMAN. Dr. Carter. Mr. CARTER. Certainly, I was impressed by the statement, Mr. Cohen, and also by the impressive charts. About the contingency fund, I would like to know if you have available statistics concerning deformities and still-born children resulting from German measles each year. Do you have that at hand? Dr. STEWART. Mr. Carter, I don't have it at hand, but I can get this data for you if you wish it. (The information requested follows:) It is conservatively estimated that the 1964-65 German measles epidemic resulted in upwards of 30,000 abnormal pregnancies. In addition to thousands of fetal and newborn deaths, some 20,000 infants were born crippled with such defects as cataracts, deafness, mental retardation, and heart disease. Assuming that a vaccine had been ready for use or for testing in 1964, many of these deaths and abnormalities would have been prevented. Mr. CARTER. I think that would be quite interesting since it is admitted that a delay of from 3 to 7 months takes place in securing an appropriation for vaccination in such cases and we could easily take that proportionate part of a year and estimate the number of deaths and deformities which would result from the lag in an appropriation which could be prevented by your contingency fund. That is all I have to say. Thank you very kindly. Mr. JARMAN. Mr. Brown? Mr. BROWN. Mr. Cohen, I wonder if I could ask a couple of questions to verify some figures. New members of the committee have to be educated in the use of figures which the rest of the committee may feel very familiar with but I personally am not. The $20 billion a year cost, would you work that up for me a bit? Mr. COHEN. Yes, the estimate of the $20 billion in the economic cost is composed of estimates giving the loss of output due to individuals who have to withdraw from the labor market, or from their other occupations, the loss of tax revenue that is involved in their not working, and in the additional cost for treatment and prevention. As I said, the treatment and prevention cost is in the neighborhood of $4 billion a year at the present time. The estimated loss in tax revenues for people who can't work is about $312 billion. The remainder largely is due to the loss in the output because of inability to work or conduct their regular occupations. Mr. BROWN. And this is based on how many mentally ill people? Mr. COHEN. This is an annual cost based upon the estimated incidence of mental illness at the present time. Mr. BROWN. Or those who are mentally ill and not hospitalized. Mr. COHEN. Yes, including the hospital costs which, of course, are the largest costs. Of the $4 billion, about $212 billion is inpatient hospital care, and roughly about $1 billion is outpatient care. Mr. BROWN. If I understood the figures presented on the charts, there are 702,000 persons in mental hospitals at present. Mr. COHEN. No: that would have been the number; 700,000 would have been the number if the projections from years prior to 1955 remained correct. Mr. BROWN. Would have been. Are you using those figures? Mr. COHEN. No; I am using the 1966 figures of the people who were actually, first, hospitalized; second, had a spell of mental illness that required outpatient care; and third, had to withdraw from the labor market because they had a period of mental illness. Mr. BROWN. 452,000? Mr. COHEN. Well, 452,000 is the total that were in a State or local mental hospital. That does not include the people who have outpatient care, or who were treated by the psychiatrist in his office. Mr. BROWN. May I have those figures? Mr. COHEN. Would you like the detailed figures? Mr. BROWN. I would like to get those. Mr. COHEN. I will be glad to get that information for you and supply it for the record, yes. Mr. BROWN. I would appreciate that. (The information requested follows:) The number of patients resident in State and county mental hospitals at the end of December 1966 was 426,300. The estimated number of patients receiving outpatient psychiatric services in 1966 was 1,885,000. This includes patients under care in outpatient psychiatric clinics as well as those receiving private psychiatric care. Mr. BROWN. May I ask one other question in connection with the decline in these figures of people in mental hospitals. The problem of narcotics generally in the Nation-has this had an appreciable effect on these figures, or do you estimate that it may have an appreciable effect, and is it included in these figures here? Dr. YOLLES. A small percentage, Mr. Brown, of that number would be accounted for by narcotics addiction. By and large, addicts are not hospitalized in State or county hospitals. There are a total, it is estimated, of about 60,000 in the United States at the present time. That is an estimate by the Federal Bureau of Narcotics. Mr. BROWN. Do you have any figures to pick out of this number, those whose mental incapacity may be the result of narcotics use? Dr. YOLLES. It would be rather difficult to do, Mr. Brown. We can give you figures on narcotic addiction and losses due to narcotic addition but to relate that to an inhospital population would be rather difficult. Mr. BROWN. In other words, I am trying to determine whether they have people in this figure who are in the hospital because of the use of narcotics or hallucinogenic drugs? Dr. YOLLES. Relatively few. Mr. BROWN. You have no exact figure? Dr. YOLLES. No exact figure. Mr. CARTER. I notice that there has been a decrease in the number of inpatients of institutions from 702,000 to 452,000. That, of course, is due to more than one thing, is it not? Dr. YOLLES. Yes, sir. Mr. CARTER. New drug therapy for mentally ill patients as well as new methods of treatment and establishment of centers. Thank you, sir. Mr. BROWN. And it is due also to the fact that some people are being returned home as part of this therapy more quickly. Dr. YOLLES. In part, yes, and also due to the availability of community facilities to treat them in the community with a more intensive sort of treatment. Mr. BROWN. I have no further questions, Mr. Chairman. Mr. JARMAN. Mr. Secretary, you referred on page 13 of your statement to the botulism problem out of which an emergency situation arose in fiscal year 1964. I would only comment that this subcommittee played an active part in that problem with correspondence with the Food and Drug Administration and with the Public Health Service and it might be well to include without objection at this point in the hearing the correspondence that the subcommittee had with those agencies. (Correspondence referred to follows:) HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, Washington, D.C., November 26, 1963. HON. GEORGE P. LARRICK, Commissioner, Food and Drug Administration, Department of Health, Education and Welfare, Washington, D.C. DEAR COMMISSIONER LARRICK: I have become concerned lately, as I know you have also, over the recent outbreaks of botulism poisoning in the United States, arising first out of certain fish products, and more recently out of imported canned liver paste. I understand that technological studies are being made to develop practices for long-range application to prevent botulism. I would appreciate it if you would send us a report on the current status of these studies. Sincerely yours, KENNETH A. ROBERTS, Chairman, Subcommittee on Public Health and Safety. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. KENNETH A. ROBERTS, FOOD AND DRUG ADMINISTRATION, DEAR MR. ROBERTS: We have your letter of November 26 referring to the recent outbreaks of botulism. You are entirely correct in your understanding that this is a matter of deep concern to us and we have been anxious to do everything possible to acquire the necessary facts which will lead to the prevention of further outbreaks. The problem, as we see it, breaks down into three parts at the present time and we are enclosing three summaries which discuss the problems in brief and outline the steps which are being taken to try to solve these problems. If we can supply further information please let us know. Sincerely yours, [Attachment 1] JOHN L. HARVEY, Deputy Commissioner. TYPE E BOTULISM FROM SMOKED FISH DECEMBER 9, 1963. Three outbreaks of type E botulism have been traced to smoked fish products in the past three years. An outbreak of three cases (two fatal) in Minneapolis, Minnesota in September 1960 was traced to a vacuum packed plastic bag of smoked ciscoes packed by a Wisconsin firm. An outbreak in the TennesseeAlabama area in September-October 1963 resulting in 14 cases of type E botulism, with at least five fatalities, was traced to one shipment of 175 lbs. of vacuum-packed smoked chubs shipped by a Michigan firm to a grocery chain warehouse in Nashville, Tennessee in late September. This shipment was unrefrigerted for a period of four or five days before receipt at the warehouse. The third outbreak involved the death of a man and wife in Kalamazoo, Michigan in early October, 1963 from eating part of a three to five pound smoked whitefish purchased during a weekend trip in upper Michigan. The source of the fish could not be determined but it is believed to have been a whole, smoked fish, not packed under vacuum. The prior history of the package of smoked ciscoes implicated in the Minneapolis outbreak could not be determined. Toxin could not be demonstrated in other packages of smoked ciscoes from the same firm and bacteriological tests of some 600 fish from this and another manufacturer failed to reveal C. botulinum type E. This was the first known outbreak of type E botulism from domestic commercial fishery products. Further studies and investigations carried out at that time included 1. Inoculation studies in smoked ciscoes to determine the role of vacuum packing in growth and toxin formation by C. botulinum type E under various storage conditions. 2. An inspection survey of 13 fish smoking establishments producing smoked fish by the "hot smoking" process in various parts of the country to determine temperatures, times, and control procedures used. 3. A study or representative samples of bulk-packed and vacuum-packed smoked fish for differences in composition (moisture and salt) which would influence growth of the organism. In brief, these investigations showed that C. botulinum type E can develop toxin in smoked fish exposed to air as well as under anaerobic conditions in vacuum packages without obvious signs of spoilage; that vacuum packing suppresses surface molds and spoilage organisms, greatly extending the shelf-life of the product; that smoking times and temperatures are not subject to measurement and control in commercial operations, the process being an “art” rather than a science; that the composition of bulk and vacuum packed products are essentially the same, though subject to considerable variations. It was concluded that further studies on the problem were necessary and should include 1. The occurrence or incidence of type E spores in fresh water lakes (Great Lakes). 2. The occurrence of these spores in commercial smoked fish products and in fish-smoking plants. 3. A determination of the number of spores necessary to initiate toxin production under various time and temperature conditions. 4. A determination of processing requirements and moisture and salt levels in smoked fish necessary to destroy the organism or inhibit its development. Laboratory studies on C. botulinum type E continued through 1961. When it became apparent in early 1962 that our manpower, facility limitations and logistics problems would not permit all the proposed research to be undertaken by existing FDA staff, it was decided to proceed through research contracts at suitable universities. Negotiations were initiated with representatives of the Universities of Wisconsin and Washington in July 1962. A final contract with the University of Wisconsin was signed in June 1963, although laboratory research on methods was initiated there at an earlier date in anticipation of acceptance of the contract. Work is in progress and preliminary reports have been received on the occurrence of C. botulinum in fresh fish from the Great Lakes area. The University of Washington was unable to complete contract proposals because of personnel, facility, and space limitations. The actions taken by the Food and Drug Administration as a result of the recent outbreaks from smoked fish are essentially covered by the enclosed press release of October 25 and enclosed "Report of FDA Advisory Committee on Botulism Hazard" and statement of "Facts Underlying FDA Recommendations." Following discussions with members of the smoked fish industry and a National Fisheries Institute Committee the enclosed additional press releases of October 29 and 30 were issued. The National Fisheries Institute set up a special committee which has advised us of plans being developed for a substantial amount of investigatory work from the botulism standpoint dealing with the handling and processing of fish. Each of the 18 FDA Districts is collecting representative samples of smoked fish products produced in its geographical area. These include representative samples of imported smoked fish products previously distributed in their area and are sampling all current entries of imported smoked fish. Eight field laboratories are engaged in examination of these samples for the presence of C. botulinum type E. Because of our limited facilities, this represents the maximum number of field laboratories that are equipped to handle this work. The field Districts are currently making inspection of all manufacturers shipping smoked fish products in interstate commerce (except Alaskan firms which are being covered by local officials), and in addition, they are inspecting selected manufacturers who ship only in intrastate commerce. During these inspections, they are determining the source of raw material, general sanitary conditions, detailed manufacturing processes, type of equipment being used, and quality controls exercised. In addition to the extensive work in progress in FDA laboratories, the following steps are being taken : 1. To provide additional financial support under the University of Wisconsin contract to expedite the survey of type E contamination in the Great Lakes area and to enlist the cooperation of the Bureau of Commercial Fisheries, Department of Interior, in support of sampling operations in that area. 2. Contract negotiations are in progress with Oregon State University to undertake an ecological survey of C. botulinum type E in marine fish and environment, and in smoking establishments in the Pacific Northwest. 3. To cooperate and coordinate FDA investigations and research with similar programs contemplated by the Bureau of Commercial Fisheries of the Department of the Interior, the Public Health Service and industry groups. [Attachment 2] TYPE E BOTULISM FROM CANNED TUNA FISH DECEMBER 9, 1963. The emergency measures taken by the Food and Drug Administration, State and local officials to remove the offending tuna fish from the market and consumer's shelves as a public health measure are well known and will not be repeated here. Some 85,000 cases of tuna fish returned to or remaining in the warehouse of the packer (Washington Packing Corporation, San Francisco, California) have been destroyed under the supervision of California State authorities. In the follow-up investigation of the 1963 Detroit outbreak, FDA inspectors examined 650,000 individual cases of the California firm's tuna fish in shipments distributed throughout the country. Nearly 3,300 cans or 0.5% of these cans were classed as abnormal, a large proportion of which consisted of defective closures of the can lids applied at the cannery. Among such defective cans 22 were found to contain C. botulinum and many additional cans were contaminated with non-toxic microorganisms. By contrast, abnormal cans were rare in the shipments of other tuna packers and no evidence of significant contamination was found. C. botulinum type E was isolated from four locations in the California plant on the equipment used for handling the filled and sealed cans following heat processing. Since the processes applied were adequate to destroy C. botulinum it is clear that the product in defective containers became contaminated after this heat processing. We are most concerned with measures to prevent a recurrence of this episode. Among such measures are 1. Efforts are continuing to determine the basic reason for the defective can closures in the California plant since it is still not clear whether this resulted from malfunction of can closing machines, faults in can structure or other factors. 2. Bacteriological studies have been conducted in other tuna canneries to detect possible sources of contamination with C. botulinum. Findings have been negative. 3. Ultimately, the safety of canned goods depends upon the exercise of strict control of can sealing and processing operations on a continuing basis. This is essentially a commercial necessity to avoid health hazards and losses through spoilage. We have sought advice from outside experts in the |