Food standards As more food standards are initiated and improved, FDA becomes involved in an increasing number of hearings, many of them far more complex than before, requiring additional staff. More industry proposals for standards are expected in Escal year 1967. Existing regulations need to be reviewed and reevaluated. In addition, FDA proposes to develop certain food standard regulations on its own initiative: frozen fruits and fruit concentrates, frozen vegetables, some fishery products, fruit juices, and the fill of various containers. Some products, such as fruit juice drinks, vary so much in content that the consumer has a difficult task in assessing their true value. Five additional positions and $25,000 for research equipment are requested to handle the increased workload and the review of existing standards. Food additives Review and evaluation of industry petitions that propose the use of food additives, as well as the drafting of appropriate regulations, has been accomplished in the past several years by using personnel who ordinarily work in the area of pesticides. This was possible because the flow of pesticide petitions dropped off for almost 2 years. However, by fiscal year 1967, the pesticides workload will have returned to normal, and four additional positions are required to replace these people when they return to their former duties. Two other positions are needed to develop speedier, more accurate methods of analysis, to prepare summaries for use by administrative scientists, to conduct literature searches prior to the design of laboratory investigations, and to conduct individual toxicity tests on the increasing number of "consumer complaint" samples that are submitted for analysis at FDA headquarters laboratories. In addition, a $20,000 study is proposed to examine the factors influencing the migration of packaging components to food. Current estimates of the amounts of packaging substances in foods are believed to be unrealistically high; radiotracer techniques will be used to measure more accurately the amounts of these materials. An increase of $14,000 is requested for special laboratory equipment to be used in research projects. Workload in the pesticide regulations area decreased significantly in fiscal year 1963 when FDA placed an additional requirement on manufacturers to include three-generation reproduction studies with all petitions. Such data takes about 18-24 months to prepare, and so submissions dropped to a low level during fiscal year 1964 and 1965. Personnel who normally process incoming petitions were diverted to other tasks within BSSE. By the end of fiscal year 1966, most manufacturers will have completed the reproduction studies required of them and the flow of petitions will have returned to normal: about 40 or 50 a year. However, the same number of scientists who handled this workload prior to the imposition of additional requirements will not be able to keep pace with the number of petitions from industry in fiscal year 1967, because of the large amount of additional data that will be contained in each petition. Therefore, an additional three positions are requested for pesticide review. Another position will be needed to help fulfill FDA's obligations under the Interdepartmental Pesticide Coordination Agreement with the Departments of Agriculture and Interior. BSSE has begun a review of the USDA registered patterns of use that are claimed as "no residue" registrations, as well as those which may unintentionally create residues in milk, meat, and eggs. Eventually, FDA hopes to review manufacturers' requests for changes in the pattern of use of pesticides at the time they are submitted to USDA. Seven additional positions are requested for pesticide investigations work: two positions to expand current projects on the development of analytical reference standards and the investigation of the transfer of pesticide residues from feeds to milk and eggs, and five for studies in the general area of reproduction, genetic effects and teratology (birth defects). Particular attention will be directed to the possibility that pesticide potentiation is a factor affecting embryo development. At present, data on the heightened effects of combinations of pesticide chemicals has been gathered from tests on growing and adult animals. These studies may also lead to additional knowledge about the possible carcinogenic effects of pesticides. To support this additional staff, an increase of $80,000 is requested for scientific equipment. Three cooperative studies, totaling $90,000 are proposed in this area. Pesticide chemicals of suitable purity are needed for use as a standard against which pesticide residues can be measured; 1 contract will involve the purchase of 35 to 50 pure chemicals to serve as reference standards. Another study will deal with the capability of pesticide chemicals to cause mutations. A methodological study will develop procedures for proving whether or not tumors in test animals are produced by pesticides and, if so, whether they are malignant. Reliable tests will eliminate many disagreements between petitioners and reviewers, which must be arbitrated by review committees. Since FDA has not been able to recruit topflight specialists in this area, the agency must go to private sources to secure the services of expert tumor specialists (oncologists) and obtain tests that will prove satisfactory to all. BSSE plays an important role in this high-priority area. Bureau scientists must review animal pharmacological data contained in every investigational new drug and new drug application submitted to FDA. It takes an average of 2 days to process each of the items that require the attention of the BSSE drug review staff during the year. In fiscal year 1965, it would have taken at least 35 man-years of actual evaluation time, including clerical support, to process the 4,200 items received during the year. However, there were only 19 man-years devoted to drug review in BSSE during fiscal year 1965, and in fiscal year 1966 there will be 30 man-years. Eleven additional positions are requested in fiscal year 1967 for drug review and evaluation, including one position for the unit that handles veterinary drugs. The Pharmaceutical Manufacturers Association has estimated that there will be more new drug applications submitted in fiscal year 1967 than in the past several years, and these submissions are becoming much lengthier and more complex. FDA estimates that the total drug-review workload will grow by at least 25 percent in fiscal year 1967, compared to the fiscal year 1965 level. Furthermore, one of the agency's primary long-range goals is to speed up the consideration of drug applications by processing 75 percent of these submissions within 45 days and another 20 percent within 90 days. Presently, BBSE is able to process very few of the drug applications within 45 days. The remainder becomes part of a backlog of 800 or 900 items and is sometimes not handled for a year or more. This backlog has been a serious problem for FDA since the initial receipt in 1962 of more than a thousand drug submissions at the inception of the revised FDA drug-review program, and the backlog grew larger during the first half of fiscal year 1966. It is likely to continue to grow. The Bureau of Medicine is adding to its staff in fiscal years 1966 and 1967 for the express purpose of expediting the review process; consequently, it is essential that BSSE do the same, inasmuch as both Bureaus cooperate in the evaluation of these submissions from the drug industry. One of the factors affecting BSSE's capability to carry out its drug review program effectively has been a serious shortage of skilled pharmacologists to review industry submissions. It is important to remember that the review staff must spend a percentage of their time improving their professional skills and keeping pace with developments in their areas of specialization; a "desk" scientist who evalutes drug applications day in and day out should be able to devote at least a fourth of his time to laboratory investigations or to supplemental reading. Unless added incentives like these are provided, FDA cannot hope to attract the topflight talent it needs in tnis area. The problems that exist in the unit that reviews veterinary drug submissions are similar to those outlined above for human drug review. The current staff is unable to keep up with the workload; in fiscal year 1965, they fell at least 10 percent behind. An increase in fiscal year 1967 will enable them to keep abreast of petitions and drug submissions and to devote time to professional development and laboratory investigations, which are necessary to improve the caliber of the scientific staff. Investigations The level of effort for drug research in BSSE is disproportionately low, compared to the ratio between the investigational and regulatory activities in the areas of food and pesticides, where the investigational staff comprise over 50 percent of the total, compared to less than 25 percent of the total staff in the drug area. The increasing emphasis on reproduction data submitted with drug applications calls for expanded studies by BSSE to confirm the reliability of industry tests or to develop tests that might be preferable. The possibility that a dangerous drug like thalidomide can appear to be harmless after being subjected to approved tests clearly demonstrates the need for reevaluation of the testing procedures now in use. FDA is also concerned about nonprescription drugs, and plans to examine some of them to determine whether they contain ingredients capable of producing harmful reactions that may have gone urnoticed or unexplained in the past. For instance, it was recently found that kidney damage was associated with the overuse of phenacetin, a chemical used in certain nonprescription drugs; a warning was required on the label of drugs containing this component. Other over-the-counter drugs may require similar action. Six additional positions are requested for these projects in fiscal year 1967. Pathological data is contained in every type of submission reviewed by BSSE. The quality of this data is extremely variable, owing to the short supply of competent pathologists and the subjective character of their reports, which do not contain the mathematically objective information that toxicological reports do. A pathology register will serve as a mechanism for the exchange of information and will prove to be an invaluable source for scientists working with animal pathology data. At first a great deal of the material will be developed and supplied by FDA; eventually, outside participation in the project is expected to increase as the facilities grow and become familiar to scientists outside of the agency. To implement this project in fiscal year 1967, four positions are needed to collect photographs, microscopic slides, tissue specimens, and other samples, and to organize them into a series of illustrative cases. Growing concern over the potential dangers inherent in the indiscriminate use of new products will place an added burden on the agency in the coming year to gather more information on these items, particularly where untested chemicals are being used. One position is needed to identify and classify biological and physical hazards of household formulations into an organized source of background data. Research in this area has been neglected, yet ignorance of the possible harmful effects on the skin, eyes, and internal organs of such things as cleaning agents, special containers, toilet articles, and countless other familiar items could lead to many casualties in the home. Special attention in fiscal year 1967 will be devoted to products that could cause serious injury or death. One position is requested to work on new hazardous substances projects concerning the flammable and explosive properties of pressurized containers, and the harmful effects of various products that may be inhaled or ingested orally. 60-627-66—pt. 2- -7 An expansion in personnel and programs in BSSE will call for three additional support positions. One position is needed to aid in the planning and budgeting process: specifically, (1) to enhance BSSE's efficiency by channeling Bureau efforts into a coordinated and more meaningful pattern, and (2) to maintain essential liaison with the FDA planning and budget offices. Another position is needed to handle the increasing statistical workload originating in petitions and proposals for regulations, tolerances, and new approvals, for Bureau administrative tasks, and for the evaluation of investigation results. An additional clerical position is requested to support the increased professional staff. Six positions are requested to implement BSSE's portion of the Science Information program. The requirements in this area are outlined in the special analysis on science information. During the first full year of its existence-fiscal year 1965-the Bureau of Education and Voluntary Compliance consolidated a number of activities which were previously scattered throughout the agency. In fiscal year 1966, under the direction of a new Bureau Director, an evaluation and revision of current activities is being carried out to enhance program effectiveness. Significant projects for 1966 include the completion of five movies (one for industry, one for physicians, and three for consumers) and increased use of workshops and seminars. A drug seminar, sponsored by FDA and industry, was held in the early part of fiscal year 1966 and three additional workshops or seminars are planned this year. A major educational program is being initiated in fiscal year 1966 to inform industry and the public of the dangers of drug abuse. During fiscal year 1967, the programs and projects underway in fiscal year 1966 will be continued with appropriate refinements. Principal new projects will be directed at specific categories of consumers and industries with particular needs and problems. The drug abuse program will be expanded significantly in fiscal year 1967. To more effectively reach the public, there will be greater reliance on television and radio. The program emphasis will continue to shift from activities that respond to outside influences-inquiries, and requests for advice to a more positive program of education initiated by FDA based upon regulatory experiences, industry contacts, feedback from consumer consultants and surveys. In our consumer programs close liaison is maintained with the President's Committee on Consumer Interests. In fiscal year 1966, $75,000 is available for surveys. This will fund several surveys conducted in concert with private survey organizations, two costing about $25,000 each, and several smaller surveys. A survey initiated in fiscal year 1965 and carrying over into fiscal year 1966 will identify areas for more intensive investigation, such as consumer attitudes toward the use of pesticides, food additives, and potentially dangerous drugs. A survey of consumer attitudes toward medical quackery is planned for later in fiscal year 1966. It will be a joint project with several other agencies. This will provide insights into consumer information needs and a foundation upon which to develop more specific surveys and hard-hitting education programs. An increase of $125,000 in contract funds is proposed for 1967 to provide for about six major surveys. Examples of the proposed surveys are: 1. A survey of consumer habits to determine label reading practices. This survey would assess the effectiveness of current labeling regulations and information programs. 2. A survey to determine consumer understanding of food standards. This information will permit FDA to determine what additional educational programs, if any, are needed in this area. 3. A survey to determine consumer awareness and understanding of warning statements used on hazardous household products. This data will improve FDA's information programs in this area and serve as a basis for increased regulatory attention if indicated. Consumer consultant program (headquarters) This group plans, organizes and directs a program providing channels of communication on consumer needs, views and attitudes toward FDA program. It also plans ways in which the consumer consultants can serve as a channel of communication between FDA and consumers. The consumer consultants located in the district offices are budgeted in regulatory compliance activity. While the field specialists develop some of their own material, most of it is prepared at headquarters. Frequently the field inspectors provide the consultants with helpful suggestions for educational programs. A considerable amount of staff time is spent providing the field staff with information of interest to consumers, such as the proposed food standards for peanut butter and fruit juices. In fiscal year 1966 emphasis is being placed on preparing materials on the drug abuse program, including information packets for portable exhibits and motion picture prints. In fiscal year 1967 two positions are proposed to develop and maintain contacts with national consumer organizations, Government agencies, and mass media representatives and design drug abuse information programs for the field staff. Consumer information In fiscal year 1966 programs aimed at low-income, low-literacy and Spanishspeaking groups are being expanded. The emphasis continues to shift toward radio and television as the prime means of reaching the public. Of special importance in fiscal year 1967 will be the consumer information program on drug abuse started in fiscal year 1966. Initial efforts are directed toward informing the public about provisions of the new law. Plans for fiscal year 1967 are balanced between programs for consumers with special interest and needs and programs aimed at the general public. The techniques of communication will vary, depending on the circumstances and require ments. |