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 canning area, and we are programming increased inspection activities to check on the adequacy of controls exercised by canneries. 4. We are also examining potential problems which may arise in connection with new can making techniques and materials, from damage resulting from high speed can handling equipment, and from sanitation problems which may occur with improperly designed equipment. The National Canners Association has pursued investigations in this area to be sure that its technical recommendations to all canners are the best available. [Attachment 3] CLOSTRIDIUM BOTULINUM B IN CANNED LIVER PASTE DECEMBER 9, 1963. In late October, the Commissioner of Food and Drugs was advised by the Canadian Food and Drug Officials that canned liver paste packed by a firm in Montreal, Canada, had been responsible for the death of one person, the illness of another, and the suspicion that the product was responsible for the illness of several others. Examination by the Canadian authorities revealed C. botulinum type B in the remaining portions of the sandwich consumed by the deceased and in an unopened can obtained from the market. Two shipments had been made to the United States, one to a firm in the New York City area and the other to a firm in New Jersey. Of the first shipment, most of the distribution had been made in New York City, but a few cans had been shipped to areas covered by six of our Food and Drug Districts. Publicity by the New York City Health Department in all local news media together with immediate investigation by the FDA resulted in recovery of the redistributed lots. The second shipment was found to be largely intact with destination of the remaining portions known to the firm who advised all consignees by telegram and by letter of the circumstances. This prompt action resulted in recovery of the major portion of the outstanding lots. Examination of samples by FDA revealed a number of cans to be visibly abnormal and contents to be obviously spoiled and contaminated by microorganisms; however, no C. botulinum was recovered. Since this is a meat and food product, it was under the jurisdiction of the Meat Inspection Division of the U.S. Department of Agriculture at the time of entry into the United States. We promptly supplied that agency all of the facts available. We have no information to indicate that any spoilage was detected by them on examination at the time of entry. Informal information received by the Canadian authorities indicates that the manufacturer may not have been subjecting the product to sufficient processing temperatures to insure destruction of C. botulinum and of spoilage microorganisms. We and the Department of Agriculture are continuing to try to get additional information about this incident. HOUSE OF REPRESENTATIVES. COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, Hon. JOHN L. HARVEY, Assistant Commissioner, Food and Drug Administration, Washington, D.C. DEAR COMMISSIONER HARVEY: Thank you for your letter of December 10, 1963 together with enclosures replying to my letter of November 26 relating to recent outbreaks of botulism, and outlining the steps which are being taken to meet the problems arising out of these operations. Would you please let me know if at the present time there is any action that the Congress could take which might aid in the solution of these problems, insofar as concerns programs administered by the Food and Drug Administration. I am also writing to the Surgeon General concerning this subject. 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 December 11, 1963, concerning possible action by the Congress to help solve the problems relating to the recent outbreaks of botulism. We appreciate your interest in this matter and thank you for your offer to help meet the serious problems created by the contamination of fish with botulinus E organisms. It may well be that Congress can take action which will aid in solving this problem. We are not, however, in position at this time to make any specific recommendations for Congressional action. We believe we should continue our current investigations to develop more information before reaching any decision about the adequacy of the present statute. If we can supply further information or otherwise be of assistance in this connection, please let us know. Sincerely yours, DR. LUTHER L. TERRY, JOHN L. HARVEY, Deputy Commissioner. HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE. DEAR DR. TERRY: I have become concerned recently over recent outbreaks of botulism in the United States, and have been in touch with the Food and Drug Administration concerning measures which they are taking leading to the prevention of further outbreaks. Would you please let me know what the Public Health Service is doing in the field of botulism, specifically with reference to insuring adequate supplies of necessary antitoxins in the United States. Sincerely yours, KENNETH A. ROBERTS. Chairman, Subcommittee on Public Health and Safety. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, PUBLIC HEALTH SERVICE. Washington, D.C., January 2, 1964. HON. KENNETH A. ROBERTS, Chairman, Subcommittee on Public Health and Safety, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. DEAR MR. CHAIRMAN: This is in reply of your letter of December 11, 1963. The Public Health Service shares your concern over the recent outbreaks of botulism in the United States and has taken concrete steps to fulfill its responsibility in the control of botulism. The Communicable Disease Center in Atlanta has recently purchased supplies of botulism antitoxin that can be used for the treatment of Type E botlulism. This material is currently being tested for potency and when these tests are conpleted, the State Health Departments and all hospitals will be notified that this material is avaliable at any hour by calling the Communicable Disease Center. Negotiations are being conducted with producers of botulism antitoxin to increase the available supplies. Unfortunately, the production time approaches two years. The material now available at the Communicable Disease Center will act, however, as an emergency stopgap supply. In addition to the procurement of antitoxin, the Public Health Service is increasing its activities in consultation, research and training. Courses in diagnosis and detection of botulism are scheduled at the Communicable Disease Center and the Robert A. Taft Sanitary Engineering Center. In Conjunction with the latter course, a seminar on botulism will be held in Cincinnati. I hope this answers your questions, but if I can be of any further assistance, please feel free to call on me. Sincerely yours, Mr. JARMAN. Mr. Rogers. LUTHER L. TERRY, Mr. ROGERS. Mr. Chairman, I notice from the tables for measles that you have made considerable progress with the vaccination program against measles, Dr. Stewart. Dr. STEWART. Yes, sir. Mr. ROGERS. From 1963 to 1964, when you almost hit 32,000 cases, you are now down to 2,000? Dr. STEWART. That is correct. This year we are having our measles eradication campaign which the President announced and we are having great success and hope to reach our goal of eradication. Mr. ROGERS. I notice that where you have a vaccine for, I presume, the regular measles as distinguished from german measles, that there are more of the common cases than there are of the german measles? Dr. STEWART. Well, there have always been more of the regular measles than the german. Mr. ROGERS. I mean, even with the vaccine. Dr. STEWART. There is no vaccine for german measles. Mr. ROGERS. But we have it for the common measles? Dr. STEWART. That is correct. Mr. ROGERS. Yet with the vaccine program we still have more of those than of the german measles? Dr. STEWART. It is more common than the german measles. Regular measles is a universal disease. Everybody has it. German measles is a less common disease. It occurs across a period of time. Mr. ROGERS. I understand that. The point I am making is that here we have a vaccine and we have had quite a number take the vaccine, I presume? Dr. STEWART. This is correct. Mr. ROGERS. Or we wouldn't have made such progress since 1963. Mr. CARTER. Mr. Chairman, will the gentleman yield? Mr. ROGERS. Yes. Mr. CARTER. That was only made available in 1966 publicly so that we could hardly expect immediate eradication. I want to assure the gentleman that according to the best authorities I know of it will be eradicated within the next year. Dr. STEWART. Mr. Rogers, if this occurs it will be the first time in the history of man that we have eradicated a disease in a 2-year or 3-year period. Mr. ROGERS. How long has the vaccine been available? Dr. STEWART. About 3 years. Mr. ROGERS. So this is most encouraging? Dr. Stewart, now I would think that you would keep us advised just as you did in these other vaccines so that the Congress could appropriate whatever money is necessary for the german measles. I assume that could be done? Dr. STEWART. Yes. Mr. ROGERS. Would the Department give us sufficient time to know? Dr. STEWART. Yes, if we have the time ourselves. Mr. ROGERS. As soon as you have indications of a breakthrough, you would let us know? Dr. STEWART. Yes. Mr. ROGERS. You would have to come to get money for trial tests, anyway? Dr. STEWART. Correct. Mr. ROGERS. Thank you. Let me ask one or two other questions. Who determines the contributions to be made by the State or the local interest in building a community mental health center? Dr. YOLLES. It is done by the applicant himself. The applicant for construction grants will apply to the State for approval before the application can be submitted to the Federal Government. Mr. ROGERS. I don't know if you got the thrust of my question. In some States I understand they may require a 50-percent contribution by the local interest to get a matching amount. Some other States may have 66-percent Federal grant and only 33% local. Who makes the determination that varies this from State to State? Dr. YOLLES. The Federal matching or the Federal percentage is actually determined by the Federal Government in terms of the relative need of the State. Mr. Rogers, are you talking about the total Federal percentage applicable? Mr. ROGERS. In each State. For instance, in Florida, I understand you can get more than 50-percent contribution for projects within the State of Florida. Dr. YOLLES. That is the Federal percentage. Mr. ROGERS. Whereas in another State they may get 66 percent within that State. Who determines that figure? Mr. COHEN. That is determined by the Secretary, based on figures from the Department of Commerce. That is a mathematical determination. The relationship of the States per capita income to the national per capita income is derived from the Department of Commerce figures and promulgated by the Secretary according to these Department of Commerce figures. Mr. ROGERS. I thought we, under the law, had given him some additional authority. Mr. COHEN. Once that is determined, then a State has an option between taking that uniform rate, whatever it is, and applying that same percentage to all projects or having a variable rate for various projects. That is a determination that is made according to the statute by the State agency. Mr. ROGERS. So the State actually determines how they will participate whether it will be on an overall figure for all of their projects or whether it will vary. Mr. COHEN. They have a choice to make after the actual rate for the State is determined by the Federal Government. They may choose to make the rate uniform on all projects, or they might create a variable rate for different projects. |