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Mr. Brows. And it is due also to the fact that some people are being returned home as part of this therapy more quickly.

Dr. Yolos. 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. Brows. 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

Incles. (Correspondence referred to follows:) HotST OF REPRESENTATIVEs. CoMMITTEE ON INTERSTATE AND FOREIGN CoMMERCE. Washington, D.C., November 26, 1963. Hox. GEORGE P. LARRICK. Commissioner. Food and Drug Adminisfration, Department of Health, Education and Welfare. Washington, D.C.

DEAR CoMMIssroxER 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. RoREETs,
Chairman, Subcommittee on Public Health and Safety.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, FOOD AND DRUG ADMINISTRATION. Washington, D.C., December 10, 1963. Hon. KENNETH A. ROBEETs, House of Representatives, Washington, D.C. DEAB 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. 8incerely yours, JoBN L. HARVEY, Deputy Commissioner. [Attachment 1]

TYPE E Borul ISM FROM SMoRED FISH

DECEMBER 9, 1963. Three outbreaks of type E botulism have been traced to smoked fish products * the past three years. An outbreak of three cases (two fatal) in Minneapolis, woesota in September 1960 was traced to a vacuum packed plastic bag of sovoked ciscoes packed by a Wisconsin firm. An outbreak in the TennesseeA woma 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 O. 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 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 0. 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.

HotJSE OF REPRESENTATIVES, CoMMITTEE on INTERSTATE AND For EIGN CoMMERCE, Washington, D.C., December 11, 1963. 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 nresent 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. Robf RTS, Chairman, Subcommittee on Public Health and Safety.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, FooD AND DRUG ADMINISTRATION, Washington, D.C., December 24, 1963. Hon. KENNETH A. ROBERTS, House of Representatives, Washington, D.0. 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,
JoBIN. L. HARVEY.

Deputy Commissioner.

House of REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE. Washington, D.C., December 11, 1963. DR. LUTHER L. TERRY, The Surgeon General, Public Health Service, Washington, D.O. 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

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