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exposed animals are slaughtered. By the end of the fiscal year, some 638 flocks of approximately 231,800 sheep were under surveillance for scrapie in 26 States. This is a decrease from fiscal year 1962 when 1,236 flocks were under surveillance.
There follows a listing of Federal and cooperators indemnities :
NOTE.-Federal amounts represent obligations; cooperators amounts reflect actual payments reported by the close of the Federa) Ascal year.
Anaplasmosis.-As a result of extensive cooperative efforts began in 1955, anaplasmosis has been eradicated in Hawaii. Only one reactor animal was located among native Hawailan cattle during fiscal year 1963.
Limited surveillance activities will need to be continued in Hawaii to assure that anaplasmosis does not recur and that all imported animals are free of the disease. Surveys are being conducted in a number of the continental States to determine the extent and prevalence of anaplasmosis.
Poultry disase control.-Cooperative activities were conducted in fiscal year 1963 in the State of Minnesota under the Minnesota pilot infectious sinusitis program with 738,000 breeder-type turkeys tested for Mycoplasma callisepticum. This completed 2 years of field trials to determine the effect of such a program in controlling the disease.
The rate of sinusitis infection in turkey breeder flocks was reduced from an extremely high incidence to only 6 percent. The results of the project were so convincing that the Minnesota Livestock Sanitary Board adopted it as an official State regulatory program effective September 1, 1963, at the request of poultry producers in the State.
In Maine the cooperative State-Federal activities on rearing poultry under practices and procedures designed to keep the birds free from exposure to disease has made good progress this past year.
In fiscal year 1963, the Maine program consisted of 20 breeder flocks; that is, flocks used in supplying the chicks for the 65 specific pathogen-free broiler chicken or commercial “meat" flocks. One and one-half million broilers were grown and processed. The specific pathogen-free (SPF) broilers at slaughter weighed approximately 0.4 pound more at 9 weeks on one-half pound less feed consumed, than nonspecific pathogen-free broilers.
Laboratory tests of SPF flocks revealed no serological evidence of pullorum disease, no fowl typhoid, and no paratyphoid. Physical inspection showed no evidence of laryngotracheitis or fowl pox.
Equine piroplasmosis.—During fiscal year 1963, 138 equines on 98 premises in Florida and 16 equines on 1 premise in Georgia were found infected with equine piroplasmosis. The infected horses in Georgia were slaughtered and tickicides were applied to the stables. In Florida, such control efforts consists of spraying horses and stabling premises with tickicides every 21 days. During fiscal year 1963, a total of 16,195 equines and 7,311 cattle associated with equines required spraying.
Thus far, cooperative Federal-State efforts appear to have prevented further spread of the disease. However, there continues to be danger of spread of the disease since surviving horse stock remain carriers and thus are potential spreaders. In addition, ticks and possibly other vectors transmit the disease. Preventive measures developed by the Department and the State of Florida to prevent the spread of the disease to racehorses in Florida appear to have aided the control program. These include spraying of raceway premises, control over sales of hay, prohibition of dogs (known to harbor ticks that spread equine piroplasmosis) at tracks and procedures for stabling and inspection of horses.
Vesicular disease investigation8.—During fiscal year 1963, field veterinarians investigated a total of 236 premises with suspected vesicular disease cases. Laboratory confirmation of specimens collected from these cases showed 126 with vesicular stomatitis, and negative results for foot-and-mouth disease, a disease clinically identical to vesicular stomatitis.
An entomologist and epidemiologist were assigned to the vesicular stomatitis endemic area in the Southeast to conduct insect surveys and develop epidemiologi. cal data in an attempt to disclose the means of transmission of the disease.
Field investigation of each case is handled on an emergency basis with laboratory confirmation obtained within 36 hours from the time of initial investigation. These activities are essential as the early diagnosis of foot-and-mouth disease in the United States would be essential to successful, early eradication. The alternative would be an extensive control and eradication program. Supervision over interstate movement of livestock
Animal health inspection at public stockyards and in marketing channels benefits livestock industry. It provides reliable and current knowledge of the health status of our Nation's livestock through competent and continuous inspection of animals moving through interstate commerce. In addition, effective inspection of intransit livestock provides a built-in alarm system for quick warning of ànimal disease outbreaks when they occur.
In fiscal year 1963, over 56 million head of livestock were examined by qualified veterinarians and livestock inspectors. This includes over 20 million cattle, nearly 9 million sheep, and over 26 million swine. The inspection service includes supervision of dipping (for scabies), testing for animal disease, and vaccination of swine and cattle.
In addition, increased efforts were directed toward animal identification and livestock diseases “tracebacks" to farm or ranch of origin. This valuable information assists field personnel in screening animal diseases in marketing channels so that eradication efforts can be efficiently and effectively directed to herds with known disease problems.
The following data show the comparative volume of activity at the public stockyards in the fiscal years 1962 and 1963:
Screw-worm inspection activities continued along the Mississippi River to protect screw-worm-free Southeastern States.-Although progress in the Southwest screw-worm eradication program greatly reduced screw-worm infestations, inspection activities were continued in 1963 to protect the free Southeastern States by maintaining an inspection line at the Mississippi River. Almost one-half million animals moving eastbound were inspected at stations along that river. No screw-worm infestations were found in the Southeast States during 1963.
Interstate regulations enforcement.-The following programs are administered under interstate regulations enforcement:
(1) Enforcement of the 28-hour law. (Act of June 29, 1906).
(2) Enforcement of the regulations promulgated under authority of the animal quarantine laws. (Acts of May 29, 1884; February 2, 1903; and
March 3, 1905). Twenty-eight-hour law. The 28-hour law seeks to insure the interstate transportation of livestock in a humane and safe manner as well as to prevent or minimize losses to shippers by safeguarding the health and condition of the animals while en route to ma ket, fa or ranch destinations. In enforcing this law, inspections at more than 600 feed, water, and rest stations maintained by rail carriers within the continental United States are made to insure that the facilities and equipment (livestock pens, etc.) are adequate and properly maintained. Unsatisfactory or dangerous conditions are brought to the attention of the railroads operating the facilities for correction. Railroad waybills and similar documents are checked by our inspectors to ascertain if the live stock are fed, watered, and rested within stipulated limits. During fiscal year 1963, inspectors reported 556 apparent violations of the 28-hour law. In the same period, 190 cases were referred to the Office of the General Counsel for prosecution, and penalties were imposed in 179 cases.
Regulatory laws.-Inspection for compliance with the animal quarantine laws is conducted throughout the country at highway and railroad points, stockyards, and livestock centers. In fiscal year 1963, field inspectors reported 638 apparent violations of the animal quarantine laws. Investigations of 345 such cases was completed in that period and sent to the Office of the General Counsel. Also, notice was received during fiscal year 1963 of successful prosecution of 104 cases.
VIRUS-SERUM-TOXIN ACT Dr. CLARKSON. We have several items of increase that I have not yet mentioned. One is for $195,000 for strengthening the surveillance over veterinary biologics. Under the Virus-Serum-Toxin Act, we have the responsibility for licensing all biologics used on animals. This task has been carried out for quite a number of years. In recent years, we have reviewed with the committee the increasing numbers of these veterinary biologics. The increase is reflected in a wide variety of products, but more particularly, the use of live organism-types of products has greatly multiplied the complexity of the regulatory job. The Department must determine that the biologics distributed in interstate commerce are free of contamination and will not actually spread animal diseases. Also, they must be effective to carry out the job that they are made for—to prevent spread of disease or to diagnose or treat diseases. We are requesting an increase of $195,000. Primarily this would be used to perform needed check tests on lots of vaccines and other biologics where we have reason to suspect that they are not up to standards.
(Explanatory notes material follows :) An increase of $195,000 for increased activities under the Virus-Serum-Toxin Act to assure safety and potency of veterinary biologics.
Need for increase.-The Virus-Serum Toxin Act seeks to prevent the production and marketing in interstate commerce of worthless, contaminated, dangerous, or harmful veterinary biologics. Enforcement of the act is accomplished under a system of licensing, inspection, and testing. Enforcement needs have increased greatly because of the continuing increase in the number and kinds of veterinary biologics. Moreover, new products are always in the process of development, and these must be critically evaluated before and after licensing to assure safety and potency. Additional funds are needed for more adequate enforcement of the act.
Many thousands of production lots (serials) of different vaccines, bacterins, serums, diagnostic agents, and related products are produced and marketed each year. When such products meet production standards prescribed by the De partment under the act, they are important tools for the prevention and treatment of livestock production. However, veterinary biologics improperly produced and not completely tested before use may themselves constitute disease hazards. Impotent products are equally dangerous inasmuch as they do not accomplish the intended purpose and leave a false sense of security. A particular problem at this time is the increasing use of live virus vaccines which now constitute about 90 percent of total production.
In fiscal year 1963, 64 licensed veterinary biologics establishments produced a total of 12,021 production lots of 140 different vaccines, serums, etc., used for the diagnosis, prevention, and treatment of 47 different livestock diseases. At the National Animal Disease Laboratory, Ames, Iowa, it was possible to perform check tests on production lost of only 17 of the different biologics produced. The limited check testing showed that 311 production lots were unsatisfactory. A larger proportion of production lots should be tested.
Of the total check testing performed in fiscal year 1963, the products for only four diseases were tested in the "host" animal (the animals the products are licensed to protect). This is an important test which should be carried out on a much wider scale. Plan of work. The proposed increase would provide for
Check testing of lots of products for seven of the most important diseases which can be tested only in the host animals;
Additional surveillance of the lots produced for six more diseases which can be tested in laboratory animals but must be validated in host animals; and
Intermittent check testing of other products.
EXAMPLES OF RECENT ACTIVITY
Veterinary biologics licensing, inspection, and testing under the Virus-Serum
Toxin Act Licensing.-Licenses required under the act to prevent the production and marketing of worthless, contaminated, dangerous, or harmful biologics permitted ; the manufacture of 140 different biologics by 1,400 methods of production at 64 licensed establishments. Improvements and new developments were made in 16 standard test procedures to be used as a basis for releasing biologics.
Inspection.-Inspection of the production and testing of a total of 12,021 production lots (5 billion doses which is an increase of 400 million doses over fiscal year 1962) was carried out at 64 licensed establishments. Samples of each production lot were collected and forwarded to the biologics control laboratory, National Animal Disease Laboratory.
Testing.–Testing of commercially produced veterinary biologics at the National Animal Disease Laboratory during the year was devoted to those products which are used in national disease eradication or control programs such as Brucella abortus vaccine and antigen, pullorum antigens and turberculin, and other high priority products, such as blackleg bacterin, Leptospira bacterin, bovine rhinotracheitis vaccine, erysipelas vaccine, Newcastle disease vaccine, bronchitis vaccine, canine distemper vaccine, rabies vacine, and others. Assays were made including those for sterility, purity, safety, and potency.
Continuing the work which was started last fiscal year, some of the assays conducted were of a screening nature in which a variety of cultures of organisms used by licensed establishments for the production of bacterial vaccines were checked for purity and contamination. Some impure and contaminated cultures were disclosed and action was taken to prohibit the use of these cultures thereby preventing the marketing of contaminated and impure products.
Activities in connection with veterinary biologics work are reflected in the following table:
The following table shows the volume of biological products certified for export:
In 1963, 17 U.S. veterinary permits were issued for the importation of biological products.
In addition, there were 152 permits issued for the importation of organisms and vectors and 95 permits issued for the interstate movement of such agents. These agents, some of which are not known to exist in this country, were permitted entry for research purposes only by qualified research workers in acceptable facilities in a manner which assures safety to the livestock and poultry industry. Before permits were issued a review was made of the responsibility and competency of the research workers. Knowledge was gained primarily through inspection visits to research facilities and review of security measures enforced. Specific conditions of permits restricted research to in vitro work in some cases, and in vitro and in vivo research involving laboratory animals in other cases. Other conditions restricted further movement of the agent and related infective material, proper disposal of infective material, and cleaning and disinfection of quarters and equipment.
Dr. CLARKSON. We are asking for an increase of $800,000 to strengthen our activities in the registration of pesticides moving in interstate and foreign commerce.
(Explanatory notes material follows:) An increase of $800,000 to strengthen registration and enforcement activities related to "economic poisons” regulated under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and related laws.
Need for increase. The basic statute establishes requirements for the registration of economic poisons (pesticides) in interstate commerce. An economic poison is defined as any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any insects, rodents, fungi, weeds, and other forms of plant or animal life or viruses except viruses on or in living man or other animals—which the Secretary of Agriculture shall declare to be a pest. The Department regulates pesticides from the standpoint of both usefulness and safety. The President's Science Advisory Committee emphasized the need to strengthen activities under the act in the report on "The Use of Pesticides."
Over 56,000 pesticide formulations are registered at the present time and an increasing number are being presented for registration annually. The collection and examination of official samples is the only means available to enforce the registration requirements. At the present time, it is possible to collect and test only about 2,000 of the more than 56,000 pesticide formulations on the market, or about 3.5 percent. This rate of enforcement work is not adequate.
It is necessary to expand enforcement activities to assure that pesticide products are formulated and distributed for use in accordance with the registration of the product under the act. Presently, enforcement activities are complicated by the need to cover large geographical areas and by industry practices of shipping pesticidal materials or concentrates to formulating plants within agricul. tural areas from which the formulated product is distributed into nearby States.