Inspections, Compliance, Enforcement, and Criminal Investigations

Guide to Inspections of Low Acid Canned Food 4

Manufacturers - 1

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some 230,000 cases of product. At this same plant, during an inspection of the companies warehouse, FDA investigators discovered abnormal cans of vegetarian vegetable soup, which lead to a recall of 1,100 cases of the product (although no spores or toxin were found). No clinical cases of botulism were associated with this second episode.

As a result of these episodes the National Canners Association (NCA), now known as the National Food Processors Association (NFPA) presented a petition to the Commissioner of the FDA proposing a statement of policy and interpretation regarding the application of emergency permit provisions of Section 404 of the Federal Food, Drug and Cosmetic Act.

The petition was regarded as a regulation proposal and was published for comment. After receiving comments, FDA published a tentative final order containing minimum good manufacturing practices (GMP) regulations. After receiving comments again, the final rule was issued in January, 1973 as Title 21, Code of Federal Regulation (CFR) Part 128b-Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers (recodified as Part 113 in 1977). The regulations governing application of section 404 were more complex and were not published until May, 1973 as 21 CFR Part 90-Emergency Permit Control (recodified as Part 108 in 1977). Parts 90 and 128b were amended in April, 1974. In March, 1979, Part 108 was revised by adding a new section (108.25) for acidified foods; a new GMP for acidified foods was published (Part 114); and Part 113 was revised.

Section 404 of the FD&C Act states in part:

"Whenever the Secretary (Secretary of Health and Human Services; in reality the Commissioner of Food and Drug Administration by delegation of authority) finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with microorganisms during the manufacture processing, or packing thereof...be injurious to health and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then...shall promulgate regulations providing for the issuance to manufacturers, processors, or packers of such class of food... of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health..."

This means that when FDA determines that a class of foods may be contaminated with microorganisms and be injurious to health, and the injurious nature of the product cannot be determined after shipment in interstate commerce; the agency can issue regulations governing the issuance of permits (Part 108), with attached conditions of manufacturing (Parts 113 and 114).

FDA determined that LACF, and later acidified foods, fell into a class of foods intended to be covered by section 404.

The regulations [21CFR 108.19(b)] state that processors are exempt from the requirement to obtain a permit only if they meet the requirement of the regulations established in Subpart B (21CFR108.25 and 108.35) which require compliance with the GMP regulations in 21CFR 113 and 114. At the time of initial start up of operations at a new processing plant the GMP regulations are considered the "attached conditions governing the manufacture..."(referred to in Section 404 of the Act).

LACF and acidified foods (108.35 and 108.25, respectively) are the only foods for which regulations have been issued under Section 404. As noted previously, the preparation of these regulations was a joint effort between the industry (through NFPA), and the FDA; and the final regulations represent a consensus.

With the publication of these regulations, FDA entered a new era of factory inspections. These regulations were the first to utilize aspects of the HACCP approach to process control.

Traditionally, food plant inspections by FDA involved having a field investigator monitor manufacturing procedures during a very limited time frame; that is, facts were recorded based upon what the Investigator saw or heard during the time he or she was in the plant. Emphasis was also generally placed on basic sanitation, i.e., adequacy of raw material, storage, and processing line sanitation. This approach, while important, did not necessarily consider procedures employed by management to monitor and control the critical elements of their processes on a continuing basis from a health hazard standpoint.

The Agency realized an inspectional approach had to be developed which would reveal the adequacy of day-to-day line operations as a function of a firm's total quality assurance program; as opposed to the traditional approach which revealed only those conditions present during the FDA Investigator's time in the plant.

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