4. Assemble better and more extensive data to determine the effect that industry trends, technological changes and processes, etc., may have on public health.

5. Make suitable and timely followups of drug recalls, violative inspections, complaints, and seizures.

6. Increase support for the Bureau of Medicine with special investigative and technological assistance in review and evaluation of investigational and new drugs.

7. Develop field methodology to keep abreast of technological changes and improve current methods, and expand drug research and development efforts to supplement the increasing level of R. & Ď. being undertaken by the central laboratories.

A total increase of 170 positions is proposed to achieve these goals, consisting of 62 analysts, 44 inspectors, 8 supervisory, and 56 clerical and laboratory support positions.

The increase of $190,000 proposed for nonstaff costs would be used for special laboratory equipment required to support the additional scientific staff requested for this program.

1966 estimate:

Positions..

Amount..

1967 estimate: Positions..

Amount

Foods

678 $6, 730, 000

678

$6, 790, 000

1967 increase: Positions_

Amount....

+$60,000

FDA has recently reappraised its domestic food inventory and identified commodity areas which are a potential and significant hazard to consumer health. Those areas which show a rate of health violations over 1 percent will be inspected more frequently and more thoroughly in fiscal year 1967.

Improved inspectional methods resulting in increased productivity will free manpower from those inspections where problems of sanitation and economic frauds and cheats are the major concern. This area will be inspected approximately once every 3 years thus maintaining the same level as in fiscal year 1966. Of the over 25,000 establishments in the area of general food problems, FDA will make approximately 8,000 inspections and reinspections.

Potentially hazardous foods

The major problem in the foods area is the danger of products coming to the consumer contaminated with microbiological life, chemical additives and contaminants and pesticides which cause death, sickness, and injury which can be avoided only through constant inspection of the industry and detection and analysis, often under emergency conditions.

The technology of food production, processing, and distribution has grown far too fast for food protection principles and practices to keep pace in terms of public health. The problems have increased greatly in scope and complexity because of the rapid introduction of ready-to-eat or partially processed foods products. Many of these contain ingredients of worldwide origin that are produced with the aid of agricultural chemicals, blended and supplemented with additives, preserved by novel processes, packaged in unconventional containers, distributed widely, and offered to the consumer in convenient, attractive, but unfamiliar forms. Such products have presented, and will continue to introduce a variety of health hazards about which more information is needed by industry and the health agencies in order to protect the public.

The effects of such processes as vacuum cooling, freeze drying, and the use of plastic packaging are as yet not fully understood. The survival of microbiological organisms and contamination with pathogenic bacteria are but a few examples of these possible health hazards. This has been recognized in a National Academy of Sciences report which states, "Clearly, the centralizing tendency of the industry, with resultant large-scale production and mass marketing, and the increasing production of precooked foods not subject to cooking by the consumer and processed products stored for long periods of time at temperatures about freezing, involve potential microbiological risks on a substantial scale. ***Newer processes

of this type require close bacteriological control of raw materials, processing, and distribution. * * *”

Field research to develop methodology to detect impurity will be concentrated on these problems with emphasis given to the most immediate and serious health threats. The tragic outbreak and fatalities due to C. botulism E in smoked fish in 1960 and 1963 illustrate the hazard in foods prepared and packaged in a manner conducive to anaerobic growth. Toxin-producing staphylococcus has been encountered in precooked foods of a moist nature. Salmonella is frequently found in frozen or dried eggs not pasteurized; and infectious hepatitis has been attributed to such items as potato salad and frozen fruit juices. The myriad of these serious hazards illustrates the need for continued research to develop method of detection not only for microbiological contaminants, but for chemical contaminants and additives used as plasticizers, humectants, preservatives, texture improvers, and a host of other uses. Problems arise here when they are used in excessive amounts, substituted, or erroneously used. Emphasis is adjusted to the extent suggested by analytical results.

Foods, general

The major concern in the inspection of food plants where major health problems are not notorbus are filth and decomposition, economic cheats, and variations from accepted standards. Sterilized filth such as maggots and rodent excrete pose no particular health hazard but is obviously revolting to the consumer. Decomposed ingredients such as shrimp and fruits can be made safe and tasty, but such practices offend the esthetics of any but the most callous. Economic cheats such as label misrepresentations reading "X cents off regular price" and sophisticated and deceptive practices such as the labeling of overmatured peas, asparagus, etc., as "choice succulent products" hurt the consumer and industry.

The problems discussed above demonstrate the need for increased coverage in all areas pertaining to potentially hazardous foods. FDA has further refined its food inventory to assure that the most effective coverage is given that section of the industry that poses the most immediate hazard. This category covers those with most numerous and serious violations. During fiscal year 1967, FDA proposes to increase coverage to the highest level within existing resources. Coverage of the remaining establishments in the food area will be maintained at the level of once every 3 years.

An increase of $25,000 in nonstaff costs is requested for special laboratory equipment required for this program.

There are an estimated 400,000 commercial import shipments of foods, drugs, and cosmetics offered for entry into the United States each year. FDA resources in 1965 and 1966 provide for coverage (through wharf examinations and sample collections) of only 43,000 of these 400,000 shipments. More comprehensive protection is needed in this area.

Drugs

The 8,500 commercial and the uncounted number of private imported drugs present every problem encountered in domestically produced drugs, but consumer protection is made even more difficult because FDA lacks basic intelligence data about foreign manufacturing practices and controls. The problem is further complicated by variations in foreign standards of control, labeling, packaging, and other critical phases of pharmaceutical production. Serious discrepancies in practices call for extensive sampling and analysis to assure that imported drugs, including basic ingredients, are pure, safe, effective, and correctly labeled. Foods

Lack of knowledge as to conditions and practices of harvest, processing, storage, attempted salvage, etc., calls for careful screening operations with sampling for laboratory examination. The wide range of acceptable international standards of foods and food-handling practices, ranging from primitive to ultramodern,

demands intensive sampling and examination. Accepted practices such as those concerning chemical additives and food handling in foreign countries are prohibited in the United States. This is particularly true of preservatives and coal tar colors. The pesticide problem is worldwide and calls for constant monitoring. FDA estimates that drug imports will increase from the present level of 8,000 to approximately 8,500 shipments in fiscal year 1967. Import examiners inspected by sample or wharf examations in fiscal year 1967, 7,500 of these commercial drug imports. More manpower is necessary to inspect and analyze all commercial drug shipments. The 30 additional positions proposed for fiscal year 1967 will make possible 100-percent coverage of imported commercial drug shipments not only by checking labels against contents but also by checking potency and purity. Increased emphasis will also be given to the area of potentially hazardous food products. The $20,000 proposed for nonstaff costs would be used for special laboratory equipment required to support the additional scientific staff requested for this program.

1966 estimate:

Positions
Amount

1967 estimate:

Positions..
Amount...

1967 increase:
Positions

Amount..

Drug abuse

42 $408, 000

42

$386, 000

- $22, 000 During fiscal year 1967, we anticipate approximately 6,000 samples will be analyzed by BRC field scientists. We estimate that this workload can be absorbed by the currently authorized analytical staff. This support necessary to complement the drug abuse investigation program includes "ballistic” examination of dangerous drugs in order to identify the source of the tablet and thus its route of diversion an whether or not it is counterfeit, and analyses of drugs for identification to support arrest charges. Analyses and "ballistic" examinations will be conducted at four district office laboratories, Since some initial nonstaff costs provided for in the fiscal year 1966 drug abuse supplemental are nonrecurring, a reduction of $22,000 is made in this area.

There are an estimated 2,500,000 interstate shipments of raw agricultural products per year, of which FDA has examined approximately 1 percent during the past several years. In fiscal year 1965, multiple residues were encountered in over 50 percent of the samples exhibiting detectable residues. Endrin, dieldrin, DDT, toxaphene, heptachlor expoxide, and chlordane were the residues most frequently encountered in amounts in excess of established tolerances or in excess of analytical guidelines where a "zero" or no tolerance has been established. The toxicity of these is the basic reason for the zero or no tolerance in various commodities. The incidence of detectable residues and the incidence of multiple residues demonstrate the need for continued intelligence in order to fully evaluate trends of usage as well as their impact upon man and his environement. The current level of sample examination provides the minimal intelligence necessary to evaluate the levels of agricultural chemical residues in the Nation's food supply. FDA plans to supplement its pesticide intelligence data with data from cooperating State agencies during fiscal year 1967. Using operations research techniques and the data accumulated during the past several years, FDA is currently reevaluating the pesticide sampling and analysis program. No program increase is requested for fiscal year 1967.

Although emphasis is concentrated on the health hazards caused by the food and drug industry, FDA has a responsibility to the consumer who is also exposed to cosmetics, color additives, and household products with potential health hazards and depends on their purity and quality. The Hazardous Substances Labeling Act calls for control of those convenience products found in every home and workshop. New products and the enormous number of bulk distributors, such as gas stations, which handle these products intensify the problems of assuring compliance. Of the 4,200 producers of such substances, FDA made 2,000 inspections in fiscal year 1965. Coverage at this level will continue in fiscal years 1966 and 1967 but with increased emphasis in education about items used in homes which are responsible for injuries and deaths of small children. There are approximately 2,600 establishments producing cosmetics and colors used in foods, drugs, and cosmetics. FDA will inspect about 700 in fiscal year 1966 and continue this level of coverage through fiscal year 1967. The use of colors is controlled by inspections of the food and drug plants which use colors. The potential hazards posed by products of the cosmetic industry exhibit problems which point to the need to consider strengthened legislation for this area in the future.

Executive support in each of the 18 FDA districts includes the Director, Deputy Director, hearings officer, administrative officer, and other supporting staff. No increase is proposed in fiscal year 1967.

A consumer consultant staff in the field was initiated on a full-time basis in fiscal year 1964. As the full-time consumer specialists have become better acquainted with the mass media and potential audiences within their districts, productivity, in terms of numbers of groups and individuals reached, has risen sharply, and the program has proved its value. The combined audien e reached by these varied activities has been estimated to be in the order of 2 million persons. In fiscal year 1967, attention will be devoted to develop better methods and to reaching particular population groups as school groups, senior citizens groups, etc. No increase is proposed.

The headquarters staff of the Bureau of Regulatory Compliance is responsible for the direction and coordination of FDA's regulatory activities necessary to

enforce the Food, Drug, and Cosmetic Act and other acts. This staff develops enforcement policies within guidelines established by the Commissioner and insures appropriate planning, coordination, operation, and appraisal of all activities at both Washington and field levels of the Bureau.

Although workloads will be heavier in this area, no increase is requested. Planned operations research studies to improve and possibly realine methods and functions will better show specific areas where future resources for efficient managment must be devoted.

1966 estimate:

Positions..
Amount...

1967 estimate:
Positions..
Amount..

1967 increase: Positions..

Amount...

Extraordinary nonstaff costs

1. Court costs-travel, per diem, and payment of witnesses, $80,000

$797, 000

$1,092, 000

$295, 000

During fiscal year 1965, BRC handled approximately 67 court cases and spent approximately $140,000 for the travel, per diem, and payment of witnesses. This amount exceeds the funds available in FDA's budget base by $20,000. During fiscal year 1967, preparation of approximately 100 court cases, at an average cost of $2,000 each, will require approximately $200,000. Since only $120,000 is available in the budget base, an additional $80,000 is requested.

2. Attendance at scientific meetings, $42,000

In accordance with FDA's policy to upgrade its laboratory staff capabilities additional funds are proposed to permit increased attendance for FDA's field analysts. In fiscal year 1967, $42,000 is proposed to permit eight analysts from each district to attend meetings for an average of 2 weeks.

3. Telecommunications network, $35,000

Since the fiscal year 1966 estimate was made, GSA has altered its telecommunications system, and use of the improved and expanded facilities will require an additional $35,000 to fully implement this system.

4. Travel and per diem for General Counsel's Office, $25,000

Travel and per diem costs for staff members of the General Counsel's Office, DHEW, are funded by FDA when this travel pertains to cases recommended by FDA. In fiscal year 1965, these costs amounted to approximately $18,000. On the basis of this experience and an anticipated increase in workload in fiscal years 1966 and 1967, FDA will require approximately $25,000 by fiscal year 1967. No funds for this purpose have been budgeted in the past.

5. Scientific, technical, and management workshops, $74,000

During fiscal year 1967, FDA proposes to hold approximately 15 workshops and conferences for field and headquarters staff. FDA has found that this type of meeting is an extremely valuable way to disseminate new ideas, identify and resolve problems, and to enhance program efforts and accomplishments.

6. Telephone equipment rental, $21,000

In 1965, the districts were authorized to rent an automatic telephone recording receiver for each resident inspector post. These instruments have been proven their worth, and FDA plans to continue using them in the future. The monthly rental cost is $25 per instrument which amounts to $21,000 for the 70 resident inspector posts planned for fiscal year 1967. No funds have previously been budgeted for this purpose.

7. New resident inspector posts, $18,000

FDA will increase its resident inspector posts by seven in fiscal year 1967 (from 63 to 70), at an average cost of $2,500 each. The funds requested are related to rent and certain necessary items of equipment.