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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 livestock 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 Department 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-SerumToxin 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:

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The following table shows the volume of biological products certified for export:

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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.

PESTICIDES REGULATION

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 agricultural areas from which the formulated product is distributed into nearby States.

Under the proposed increase, it would be possible to provide an average of one field inspector for every three continental States, instead of the present average of about one for every five States. When official samples are collected, they must be tested and examined in the laboratory. The samples are analyzed to determine if the active ingredients are present in the amounts listed on the label or if any ingredient has been added which would render the product adulterated. Increased sampling would require additional laboratory work.

The technical review of the scientific data required to justify registrations must also be strengthened. This requires that scientific personnel competent in the various phases of pesticide chemical use examine and evaluate all information as to the usefulness of the product, any hazards connected with its use, and the applicant's proposed label claims. There is also need to examine more critically the many amendments to existing registrations and re-registrations since the composition of many pesticides is always in the process of development. Plan of work. The proposed increase would provide for approximately 53 man-years of scientific and technical personnel and field inspectors to provide for the increasing workload. This would permit an aapproximate doubling of the collection and examination of official samples and for strengthening the work concerned with determining the acceptability of products offered for registration. Dr. CLARKSON. This is an activity that has received a great deal of attention during the past year. The efficacy of these compounds has been very widely accepted. But there has been more and more concern expressed about some of the potential long-range effects of continuing the use of powerful chemicals in the prevention or the treatment of diseases and insects and other pests.

We have, during this past year, proposed amendments of the regulations for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act. These new regulations will be issued probably within the next month.

It will be necessary that each and every one of the pesticide registrations now on file be reviewed from the standpoint of safety and usefulness. We have put a heavier burden on the applicant for registration to provide additional scientific data to show the absence of hazard, either of the chemical itself or of the formulation when used as intended by the applicant.

In this work, we seek information from other agencies of government; State enforcement officers who have similar responsibilities; the agricultural experiment stations; our own ARS research units; the Public Health Service, the Food and Drug Administration and the Fish and Wildlife people. In other words, it is a job of getting scientific data from all available sources concerning the effects of these pesticide chemicals, considering the effects of ingestion, inhalation, or skin contact, or the effects on soils, water, fish, wildlife, crops, and livestock. This is a big job becoming more complex each year. (Explanatory notes materials follow:)

Registration activities.-During fiscal year 1963, a total of 4,932 new products were registered under the act. Amended labels were accepted for 4,921 previously registered products. Such amendments involve additional uses, changes in product composition, and revised directions; and must be thoroughly reviewed. Labels submitted for 4,022 products were found unacceptable; many of these were corrected, resubmitted, and accepted as new registrations or amendments. To give increased protection, regulations under the act were extended during the year to include pesticides used against many animal and plant pests and certain viruses. These new classes of products, previously unregulated, contributed to an increase of 13 percent in the number of unacceptable labeling over 1962.

Enforcement activities.-Department inspectors collected 2,159 official samples of economic poisons in 1963 for analysis and testing. These activities provide the only means of checking products for compliance with the act. Chemical and/or biological tests were made on 1,579 official samples, of which 407 were found to be

seriously misbranded, or adulterated, or otherwise in violation of the act so as to warrant citation and/or seizure.

During the year 257 shipments of economic poisons were offered for entry into the United States. Of these, 22 were examined and 12 shipments were detained due to nonregistration or other violations. These shipments were later brought into compliance with the act or were destroyed or returned. The remaining shipments did not require sample testing before being released.

Laboratory screening of products intensified.—As a means of providing a further check on the safety of pesticide formulations, routine laboratory examinations of products has been increased. Several shipments of potentially hazardous products were seized as a result of these screening tests.

Tests on laboratory animals were conducted to check further on the safety of livestock pesticides.

Public information issued relating to pesticides.-During fiscal year 1963, a film has been completed entitled "Safe Use of Pesticides." The film was prepared in cooperation with the Food and Drug Administration and has been distributed nationwide.

The publication "USDA Summary of Registered Agricultural Pesticide Chemical Uses" has been distributed throughout this country and in more than 48 foreign countries. This publication is a compilation of pesticide uses on food crops which have been registered under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended. It serves as a valuable guide to research and extension workers and regulatory officials concerned with the recommendation or regulation of these products.

Consideration being given to revision of regulations under the act to provide greater safety concerning pesticide products.-A general revision of regulations under the Federal Insecticide, Fungicide, and Rodenticide Act has been prepared and published in the Federal Register for public review and comment. The revisions are designed to strengthen the regulations with respect to labeling of pesticide products. Requirements regarding the legibility and placement of labels on the products are to be clarified. The revised regulations would specify the size of lettering used with regard to warnings or cautions. Also, warnings, cautions, ingredient statements, and designated signal words would be required to appear on the front part of the label or that part displayed under customary conditions of purchase, unless otherwise authorized. Provisions would be made for economic poisons to bear on the front panel the statement "keep out of reach of children” and such a signal word as the Department may prescribe. Any claims such as "safe,' "nonpoisonous," "nontoxic," noninjurious," or "harmless" would not be permitted on the labeling.

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With respect to economic poisons highly toxic to man, the proposed regulations would strengthen the requirements regarding manufacturer testing procedures and the number and type of animals to be used. Provision is made also that registration of any economic poison may be refused if, in the opinion of the Secretary, directions for use or warnings cannot be written which, when followed by the general public, would prevent injury.

SOUTHEASTERN SCREW-WORM INSPECTION ACTIVITIES

Dr. CLARKSON. The reduction of $650,000 proposed in the budget is for the elimination of the screw-worm inspection activities principally along the Mississippi. This is no longer necessary with the success of the eradication program in the Southwest. This activity is being curtailed during fiscal year 1964. In fact, it will be terminated by June 30, 1964.

(Explanatory notes material follows:)

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