cans should be suspected as potentially botulogenic and examined for toxicity and the presence of C. botulinum. Never under any circumstances should the contents of such products even be tasted, let alone eaten without thorough cooking.

The canning industry, using the information provided by research carried out in the 1920's and 1930's, has adopted a standardized process for treating lowacid foods so that the probability of C. botulinum spores surviving is very remote. The spores of C. botulinum, although quite resistant, are not the most heat-resistant known, and other more resistant sporeformers are frequently used in time-temperature studies. However, canning processes must be of such lethality that the likelihood of C. botulinum spores surviving is negligible. The concentration of spores in a food product is important because the greater the number of spores there are in the product, the greater the processing time and temperature required to insure their complete destruction. Therefore, the so-called 12 D standardized canning process was designed to reduce a bacterial load of a billion spores in each of a thousand cans to the level of one spore in a thousand

cans.

These processes, which take into account among other things the consistency and chemical nature of the product and the size of the can, are now standardized to the point that only through recontamination after heating is it likely that a significant degree of spoilage or hazard from C. botulinum could occur. An additional safety factor is provided by proper sanitary control, as specified in FDA's Good Manufacturing Practice guidelines, which reduces the original bacterial load to be inactivated during the canning cycle.

The knowledge concerning the effects of chemicals, such as salt, nitrite, and organic acids, on the germination and outgrowth of C. botulinum spores has been utilized by the meat-curing industry to produce safe and acceptable products without subjecting them to the "12 D" canning process.

The preservation of food by drying, or smoking and drying, goes back beyond recorded history. Modern commercial drying processes are superior to the crude smoking-drying combinations of the past that were sometimes responsible for botulism. Freeze-dehydration and conventional air drying are commercially attractive because of increased shelf life, weight reduction, and packaging ease. Some type of pretreatment is usually required so that rapid freezing and dehydration can

Occur.

Vacuum packaging provides special hazards when foods with sufficient moisture content to allow bacterial growth are placed in an environment that will discourage growth of normal spoilage organisms on the surface, but will support the growth of anaerobes, such as C. botulinum. In vacuum-packaged foods, growth of aerobic or oxygen-using organisms is considerably curtailed, and the shelf life appears, therefore, to be extended because visible spoilage has not occurred.

This additional shelf life may be sufficient for anaerobes, such as C. botulinum, to grow and produce toxin. With vacuum-packaged foods, as with so many others, every attempt must be made to establish high levels of sanitation in the processing plant so that contamination levels with C. botulinum will be held to a minimum.

The radiation preservation of foods has been subjected to intensive study in recent years. Processes designed to pasteurize food by irradiation would have little or no effect upon the spores of C. botulinum, which are resistant to radiation damage. The extended shelf life obtained by low-dose irradiation might allow outgrowth and toxin production.

In any commercial operation for the preservation of foods, plant sanitation has an important bearing on the effectiveness of processing in the elimination of the hazard from C. botulinum. If the spores are present in the plant, they may gain access to the product through handling at any stage of the operation.

The ubiquity of C. botulinum, the resistance of its spores to physical and chemical agents, and the lethality of its toxin call for careful attention in the preparation of commercial food products. Thorough cleaning of all raw products in preparation for processing, scrupulous attention to sanitation in all phases of plant operation, and meticulous attention to processing conditions and the handling of the finished product are required. Although certain types of products have been more frequently incriminated than others, it is probable that almost any food may become contaminated. As new types of processing and packaging are contemplated, it is especially important that they be designed to eliminate the hazard presented by contamination with C. botulinum.

ATLANTA DISTRICT James Shelton, product safety consultant in FDA's Region IV, took part in an orientation seminar on product safety held September 23 at Jacksonville by the Florida Department of Health and Rehabilitative Services. Mr. Shelton was a moderator for the seminar along with A. W. Morrison of the State health department. Sam Hart, deputy director of FDA's Bureau of Product Safety, provided comments and projections for the Federal approach to be followed in the area of consumer protection. The program was well received by the top staff people of the health department for whom the seminar was being held.

BALTIMORE DISTRICT The second phase of the FDA-VDAC personnel exchange is underway; the first phase was earlier in 1971 (see FDA PAPERS, May 1971 issue).

FDA Supervisory Inspector H. Thompson Price, Jr., began a 60-day detail with the Virginia Department of Agriculture and Commerce on October 4. During this period, he will work under the direct supervision of A. Lee Turner, supervisor of VDAC's Food Regulatory Section. Mr. Price will receive indoctrination in every phase of the department's food inspection operations.

It is anticipated that this half of the exchange will be as beneficial as the first phase when VDAC detailed Howard R. Haynie to FDA's Baltimore District Office.

BOSTON DISTRICT During July-September, over two million dollars worth of canned tuna imported from Japan was denied entry into the United States through the New England ports. FDA's examination of the tuna revealed either decomposition or mercury contamination in excess of the 0.5 parts per million guideline set by the Agency.

A U.S. District Court judge sitting at Boston signed an order of destruction September 20 that brought to a close an action that had been pending since early in 1970. On February 16 of that year a quantity of veterinary drugs was seized at Harilian Pharmaceuticals, Inc., Greenwich, Connecticut, on a complaint of forfeiture charging the goods were new animal drugs for which the firm did not have an approved New Animal Drug Application. The firm entered a claim

to the drugs and filed a consent decree, but by September of this year it had not brought the goods into compliance and the recent court order was issued.

BUFFALO DISTRICT Import detentions recently have included several products from the Peoples Republic of China that failed to comply with FDA's Fair Packaging and Labeling Act requirements. These articles have been transshipped from Canada, where the producers have to a large extent taken steps to essentially comply with these regulations.

The District is concerned not only with such detentions but also with a recent problem that can vastly change its import coverage. Oceangoing vessels have been docking at Albany, New York, rather than at New York City. The boats apparently are making the trip up the Hudson to unload at this inland port to escape the longer delays. If this practice continues, it will bring about changes in Buffalo's import coverage. Bon Vivant Soups occupied a considerable portion of the District's time into the month of October. Cooperative action between the New York State Division of Food Control Office, the local health departments, and Buffalo District brought Bon Vivant products distributed in upstate and western New York under control. County health departments cooperated in embargoing small lots of these products when found in distribution. These lots were then returned to wholesalers or were destroyed. New York State or Federal seizures were made at all distributors. The State seized 268 lots, of which about 160 were in the New York City area. Federal authorities seized 18,179 cans of the soup. Some voluntary destructions of smaller lots have been accomplished and many more are anticipated in a concerted effort to assure that these questionable products do not get back into the channels of commerce.

CINCINNATI DISTRICT Homer R. Smith, District veterinarian, participated in the Farm Science Review at Columbus on September 21-23. He monitored an FDA exhibit on veterinary medicine and poison prevention that was part of the Review, which was sponsored by the Ohio State University and the Ohio Agricultural Research and Development Center.