by Joseph C. Olson, Jr., Ph.D.

NEW HORIZONS
IN MICROBIOLOGY

Efforts to control microbiological health hazards constitute one of the major consumer protection programs of the Food and Drug Administration. In this work we are not alone, for several other Federal agencies and many State and local governments are deeply involved in such programs. The magnitude of these efforts is not surprising, for it is estimated that at least 10 million cases of foodborne disease occur annually in this country, plus those infections due to contaminated cosmetics and pharmaceutical products.

This presents a problem that demands increasing attention on the part of health agencies. In seeking to reduce microbial contamination of consumer items, it is essential that we remain alert to new or modified control mechanisms. As we probe our range of perception, we can clearly see several developments likely to play major roles in increasing the effectiveness of our efforts.

The first of these is the development and use of microbiological criteria for foods. Three such criteria are in greater or lesser use today.

(1) A microbiological specification is the maximum acceptable number of micro-organisms or of specific types of micro-organisms, as determined by prescribed methods, in a food being purchased by a firm or agency for its own use.

(2) A recommended microbiological limit is the suggested maximum acceptable number of micro-organisms or of specific types of micro-organisms, as determined by prescribed methods, in a food.

(3) A microbiological standard is that part of a law or administrative regulation designating the maximum acceptable number of micro-organisms or of specific types of micro-organisms, as determined by prescribed methods, in a food produced, packed, or stored, or imported into the area of jurisdiction of an enforcement agency.

All signs point to increasing interest in this subject because of the need by regulatory agencies for objective measures that will assist in making judgments of the wholesomeness and safety of foods.

To establish microbiological criteria for foods is not a simple undertaking. The facts of life become evident as soon as we recognize the great diversity that exists in food products and in the processing operations by which they are prepared. This diversity affects in considerable measure the microbiology of a food product and thereby influences the extent of useful application of one or more of the criteria defined above. A great deal of knowledge about the microbiology of a product is needed to avoid undue consumer as well as producer risks. For example, without adequate knowledge, a standard might be set that is so restrictive that a sub

stantial percentage of producers could not meet it-in other words, a standard that technologically is not feasible. The opposite also could occur—a standard having associated with it an unreasonably high consumer risk.

Microbial counts themselves can only indicate the conditions under which a product was produced and/or the time and temperature of its storage or handling. The degree to which microbial count limits reflect the conditions of handling depends largely on the product.

Efforts toward developing and applying microbiological criteria are rapidly increasing. The exciting challenge we face is the development and application of meaningful criteria in the interest of consumer protection.

The microbiological criterion used by the FDA at present most closely resembles the second of the foregoing definitions the recommended microbiological limit. It is used to guide our administrative personnel. The guidelines specify microbial limits which, when coupled with plant inspection showing substantial insanitary conditions, provide a basis for subsequent actions. Guidelines presently exist for about 60 products. They specify count levels singly or in combination, depending upon product, for molds or mold fragments, coliform organisms, Escherichia coli, Staphylococcus aureus, and total aerobic viable bacteria.

The guidelines are not a part of a law or a regulation, hence are not microbiological standards within the definition of this term; rather, they are limits which, if exceeded, strongly indicate a process out of control and therefore a need for correction. Additional guidelines are needed to assist in effectively interpreting the results obtained from samples analyzed in our District laboratories, State and municipal laboratories, and the many commercial and industry laboratories throughout the country.

We have expanded our efforts in gathering baseline data on which to base additional guidelines; for example, our Office of Compliance recently issued a guideline for blue crabmeat-a result of our recently completed studies on that product. A study of the frozen onion ring industry is almost complete, as is a study to provide a realistic assessment of the hazard of staphylococcal enterotoxin development in cheese.

Another study under way has been jointly undertaken by the FDA and the Air Force on prepared, ready-toeat salads. The quality of prepared salads as purchased by the consumer oftentimes leaves much to be desired and some question remains concerning the safety of these foods. We are performing microbiological analyses on such salad items as meat, fish, poultry, potato, egg, and other salads for total counts as well as the usual indicator bacterial groups and species. Correlations will be developed between processing practices and microbial quality. This study should provide the basis for microbiological guidelines of the type previously indicated and we anticipate that they may serve the industry and the local State regulatory agencies as well as the FDA. Foods to which future studies will be directed

will be selected according to the potential risk they present in causing foodborne disease.

Elsewhere related activity is under way. Recently a Subcommittee on Microbiological Standards for Foods was established under the Environmental Section of the American Public Health Association. Its specific charge: formulate and implement a procedure for developing microbiological standards for foods.

As a first act, the Subcommittee conducted a survey to determine the status of microbiological standards in this country. All States were contacted along with 25 major cities and several Federal agencies. In brief, the survey revealed the following: (a) few States had established microbiological standards or guidelines for foods other than milk, water, and shellfish; (b) all expressed a need for such standards or guidelines and for immediate efforts toward development. Accordingly, the Committee stated its intention to proceed during the coming year toward development of microbial guidelines for foods.

Significant too in this regard was a resolution dealing with microbiological standards for foods recently passed by the Conference of State Sanitary Engineers and approved by the Executive Committee of the Association of State and Territorial Health Officers. The resolution stated endorsement of the concept of: “establishing reasonable and workable microbiological standards for foods, other than dairy products; and in developing uniform microbiological examination procedures therefor." The resolution also asked that the FDA "be requested to establish the mechanism to coordinate the efforts of all concerned, and that this activity be implemented as expeditiously as possible. . . .”

Here are three very influential groups in the public health field-the APHA, the Conference of State Sanitary Engineers, and the Association of State and Territorial Health Officers-actively fostering the development of nationally uniform microbiological guidelines for foods and methods of analysis, and furthermore, looking to FDA for leadership. Thus the interest and pressures mount, and since we are already heavily involved in gathering the kind of baseline data essential to establishment of meaningful microbiological criteria for foods, it seems only logical to expect that involvement to increase.

Much more could be said on the subject; for example, the extensive international activity, but let me leave it by emphasizing the close coordination needed to develop microbiological criteria for foods so we may have as much uniformity in the provisions as possible, nationally and internationally. Undue diversity in microbiological criteria that might become established in our 50 States and major municipalities for foods would, in my opinion, result in regulatory chaos and would not serve the best interests of the consumer or the food industry.

Let us turn now to another area-the keen interest that has developed recently in the microbiology of cosmetics and other topical products—and what it means