1 Paid from Office of Emergency Planning and Defense Department in 1962. 1962 enacted appropriation___. Civil defense operating budget for 1962 1. Transferred to "Operating expenses, Public Buildings Service" Gen eral Services Administration__ Administrative reserve_ $23, 000, 000 105, 000 -217, 000 -1, 146, 000 Total estimated obligations, 1962– 1963 estimated obligations_ Total change. 1 Paid from Office of Emergency Planning and Defense Department in 1962. 21, 742, 000 28, 400, 000 6,658, 000 (a) Built in: Summary of changes-Continued INCREASES 1. Annualization of 213 new positions authorized in 1962 Personnel compensation- Other related costs---- Total____. 2. 1963 equipment and maintenance costs to operate two a. New FDA building (Federal Office Building b. Special pharmacological animal laboratory-. 1. Staff to strengthen basic programs excluding programs a. Food research and standards (66 positions) –– 448, 600 482, 600 c. FDA workload census (31 positions). 210, 700 2. Staff to provide new approaches to special problems and to enforce new legislation: a. Pesticides (190 positions). b. Drugs (126 positions). 1,248,300 910, 700 192, 800 2, 351, 800 13, 600 13, 600 1,726, 200 c. Food additives (30 positions). Total--- Subtotal, staff increases.. 3. Nonstaff increases (space, equipment, and other sup- a. District office renovation___. b. First year rental of new space.. 4,078, 000 1,520,000 865, 000 $400,000 moderniza 190,000 (3) New resident inspector posts--- 600, 000 300, 000 30,000 36, 000 3, 351, 000 7,429, 000 8, 711, 000 Summary of changes-Continued DECREASES (a) Nonrecurring equipment related to new staff in 1962. (b) District office renovation___ (c) Other nonrecurring operating expenses Subtotal, decreases_. Total net change requested--- EXPLANATION OF CHANGES $211, 000 1,397, 000 445, 000 2,053, 000 6,658, 000 EQUIPMENT AND MAINTENANCE COSTS TO OPERATE New FDA Building (Federal Office Building No. 8) An amount of $200,000 is requested in 1963 for the purchase of office equipment (furniture, carpeting, shelving, and other common service furniture) for administrative offices which will be located in the new FDA headquarters building. These items are exclusive of fixed and other basic laboratory equipment to be purchased by the General Services Administration. Special pharmacological animal laboratory A total of $223,000 is requested for equipment and maintenance costs for FDA's pharmacological animal laboratory at Beltsville, Md. Of this amount, $170,000 is for the purchase of fixed and portable scientific equipment and $53,000 is to cover operating costs (utilities and maintenance) during 1963. STAFF INCREASES FOR BASE PROGRAMS EXCLUDING PROGRAMS Food research and standards A total of $448,600 is requested to provide 66 new positions for work on food research and food standards in 1963. Of the total new positions, 16 will be assigned to work on studies involving fats and fatty acids, decomposition, food technology and analysis, special dietary foods, and bacteriological work. The remaining 50 positions will be used to place emphasis on the establishment and enforcement of food standards. Of the 50 positions, 44 will be in the field and 6 in the Washington laboratories. Management services and administration A total of $482,600 and 71 positions is requested to provide management and administrative services necessary for the overall operation of the Food and Drug Administration. Of the 71 new positions, 30 will be used to provide basic supporting services in the areas of personnel, fiscal operations, procurement, records maintenance, etc.; 15 positions will work on the development and issuance of food and drug regulatory programs and the appraisal of overall operational effectiveness; 15 positions will be used to provide assistance to top FDA officials in Washington and the field, thereby permitting them to devote their full attention to direction and guidance of program operations; 7 positions are requested for FDA's computer operations; and 2 positions are requested to improve FDA's training programs. FDA workload census FDA is requesting an increase in 1963 of $210,700 and 31 positions to work on the compilation and development of a comprehensive inventory of firms subject to the Food, Drug, and Cosmetic Act. All 31 positions will be assigned to the field. Field supervision $190.300 and 28 positions are requested to provide supervisory personnel at a ratio of 1 for every 12 inspectors and 1 for every 10 chemists, as recommended by a recent study by a private management consultant firm, of FDA's field offices. Imports program $135,800 and 20 positions are requested in 1963 to provide increased attention to foreign imports. These additional personnel will permit an increase of about 1,500 sample collections, 1,000 sample analyses and 1,000 wharf examinations over the 1962 level of 14,500, 9,200 and 7,200 respectively. Staff for new pharmacological laboratory A total of $81,500 is requested in 1963 to finance 12 positions which, along with 8 positions to be transferred from existing staff, will form the nucleus of FDA's pharmacological laboratory staff. Enforcement reviews and advice An increase of 10 positions and $68,000 is requested in 1963 to provide additional impetus to FDA's enforcement of the Food, Drug, and Cosmetics Act including the review, processing, approving, and monitoring of all legal actions. Information services Seven positions and $47,500 are requested to answer the increasing volume of inquiries from industry, consumers, and outside groups concerning FDA's operations and the requirements of the law; to make speeches before such groups; for the distribution of Federal Register material; and to carry out other activities to furnish information and to promote voluntary compliance with the law. Medical information services An amount of $34,000 and 5 positions is requested to review medical literature and information in connection with drugs, therapeutic devices, cosmetics and hazardous substances. This work is essential and necessary in the review and approval of new drug applications and to develop expert medical advice and opinions to support FDA's enforcement operations. Animal feeds A total of $13,600 and 2 positions is requested to permit increased attention to contamination of feed grains by weed seeds and other toxic ingredients. Cosmetics An amount of $13,600 and 2 positions is requested to analyze cosmetics to detect, and identify ingredients of unknown value or safety, to handle the increasing volume of injury complaints resulting from the use of cosmetics, and to work in the area of economic cheats. STAFF INCREASES TO PROVIDE NEW APPROACHES TO SPECIAL PROBLEMS AND TO ENFORCE Pesticides program NEW LEGISLATION An increase of $1,248,300 and 190 positions is requested to step up, significantly, FDA's operations involving pesticide residues on raw agricultural products. The increase requested is a continuation of efforts began in 1962 to provide resources sufficient to attain a 1 percent sampling of the estimated 2,500,000 interstate shipments of food crops on which agricultural chemicals have been used in some manner. With the resources now available and those requested for 1963, FDA will attain a level of about 25,000 sample collections by 1964. Of the 190 additional positions requested for 1963, 141 will be assigned to the field, 29 to Washington laboratory operations, and 20 will provide supporting and other services. Drugs A total of $910,700 and 126 positions is requested in 1963 to accelerate FDA's efforts in the field of drugs. Of the 126 new positions, 53 will be assigned to laboratory operations, 28 inspectional personnel, 9 medical professional personnel, 3 veterinarians and 1 dentist. A total of 80 positions will be assigned to field operations. These increases will be used to step-up FDA's operations in all phases of drug work including increased inspections of drug manufacturers and distributors, processing of new drug applications and supplements thereto, review of drug literature, labels and other information for accuracy and completeness, and scientific research and methods development. Food additives An increase of $192,800 and 30 positions is requested to augment FDA's present resources in the field of food additives. All 30 positions will be assigned to the field including 15 inspectors and 7 scientific personnel. Emphasis will be placed on inspections of manufacturers of indirect food additives such as wrappers, cartons, etc., sampling of imports, and to permit FDA to increase its efforts toward making one food additive inspection every time a food establishment is inspected. NON-STAFF INCREASES (SPACE, EQUIPMENT AND OTHER SUPPORTING COSTS) District Office Renovation $1,520,000 is requested to continue FDA's program of district office renovation. Of this amount, $752,000 will provide second year costs to complete the renovation of Baltimore, Chicago, Seattle, and New Orleans. The balance of $768,000 will permit FDA to begin renovation of Philadelphia, San Francisco, St. Louis, and Denver. First year rental of new space An increase of $865,000 is requested to provide first year rental of new space to be occupied in 1963. Of this amount, $765,000 will be for space in the field as the new district offices become ready for occupancy and $100,000 for additional space to accommodate new staff in Washington. Equipment $600,00 is requested for equipment purchases in 1963 related to the following: special items of scientific equipment related to specific programs-$400,000; replacement and modernization involving primarily scientific equipment-$190,000; and for the establishment of 8 new resident inspector posts-$10,000. Study of State food and drug programs An amount of $300,000 is requested to conduct a comprehensive study of State food and drug programs with the view toward determining the relative roles and responsibilities at the various levels of government in these areas. The study will be conducted by a nonprofit organization under a contractual arrangement with the Department of Health, Education, and Welfare and will cover such items as organization; uniformity and adequacy of programs, laws and regulations; adequacy of equipment and facilities; financing; competence of personnel, etc. It is contemplated that the study would take 18 months to complete. Training (travel and per diem) An amount of $30,000 is requested to strengthen FDA's training programs. These funds will be added to the $188,000 included in the 1963 budget base bringing the total program up to a level of $218,000 in 1963. All other non-staff increases A total of $36,000 is requested to cover such items as: clinical contracts for testing of drugs and therapeutic devices, $8,000; special supply items for FDA's computer program, $8,000; reproduction of information and education material, $6,000; travel and per diem expenses in connection with attendance of FDA personnel at scientific conferences and symposia, $5,000; funds for a contract to design an FDA exhibit room for FOB No. 8, $5,000; funds for artwork contracts for FDA publications and materials, $2,000; and rental of GSA vehicles to provide transportation between FDA's scattered locations, $2,000. GENERAL STATEMENT Senator HILL. The committee will kindly come to order. We are glad to have with us this morning our good friend Mr. George P. Larrick, Commissioner of Food and Drugs of the Department of Health, Education, and Welfare. Mr. Larrick, we will be glad to have you proceed in your own way. Mr. LARRICK. Thank you, Mr. Chairman. It is good to be back here again, sir. Mr. Chairman and members of the committee, we Americans today are living in a unique era, a period when the wealth and technical abilities of our Nation are providing most consumers with more of the best food ever made available to a society and with the greatest |