"Detention Without Physical Examination of Manufacturers Of Low Acid Canned Foods And Acidified Foods"

Due to the large number of manufacturers of low-acid canned foods and acidified foods for which detention without physical examination is necessary they are consolidated into this one import alert. The attached list, in numerical order by FCE number, will facilitate the task of identifying firms whose products should be detained without physical examination. The list also delineates the products involved and the reason for detention.

The following is background for the reasons for detention
contained in the attached list:

1. Non-response - Ver

The low-acid canned food (LACF) and acidified foods (AF) regulations, 21 CFR 108.35 (c)(2) and 21 CFR 108.25 (c)(2),require domestic and foreign commercial food processors to provide the agency (FDA) with information as to their scheduled processes for each food type and container size. FDA maintains these filed processes in order to be aware of the current LACF and AF processes and to review these
processes as needed.

Specific foreign firms were requested to verify the current status of their filed processes. Non-responding firms have been contacted three times and informed of the necessity to provide the agency with this information. Even after the final letter suggested appropriate legal actions would be taken against non-responding firms, a number of foreign firms did not respond with the information needed to determine the accuracy of their current processes. Therefore, all products from these firms should be automatically detained. In the event that the requested verification information is provided later and after a favorable review, the responding firms will be removed from automatic detention status.

2. Non-response - PROC

(Non-response to request for data verifying the adequacy of the filed process)

A number of foreign firms have filed their scheduled processes, but upon review and evaluation, some were found to be potentially inadequate for one or a few (not all) products they produce.

For those questionable processes identified, the agency has attempted to obtain the additional information needed to adequately evaluate the safety of the processes. In some cases, the requested information has not been received after as many as three attempts. It is, therefore, not possible to make a determination of the adequacy of the filed processes on the basis of information now available to the agency. Therefore, the specific LACF products from those firms should be automatically detained.

3. Inadequate - pH

(Inadequate control of pH of acidified foods)

Acidified foods are acidified at or below a pH of 4.6 to control the growth of microorganisms of public health significance and are usually given a heat treatment sufficient in scope to destroy vegetative cells of microorganisms capable of growing in the reduced pH environment but not sufficient to destroy the spores of microorganisms such as C. botulinum. If acidification is not adequately controlled and spores of C. botulinum are present, they may grow and produce a deadly toxin.

Thus, products not adequately acidified represent a potential health hazard (refer to CPG 7120.25).

4. Inadequate - PROC

(Inadequate control of the processing of low-acid canned foods)

Factory inspections, sample analyses, or other data and information may provide evidence that low-acid canned foods have not been processed sufficiently to ensure public health protection. Inadequate processing of low-acid canned foods can result in the growth of C. botulinum with the subsequent production of its deadly toxin

Dietricts may detain, without physical examination, products from the firms identified on the attachment for this alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 827-7605.

Low Acid Canned and Acidified Foods as identified in the attachment for this alert

1. Non-response To 99-04 Verification

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public health [Adulteration,402(a)(4)]."

OASIS charge code - NO PROCESS


2. Non-response - PROC "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer pursuant to 21 CFR 108.35(c)(2) appears to be inadequate to protect the public health. [Adulteration, 402(a)(4)]."

OASIS charge code - NO PROCESS


3. Inadequate - pH "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate acidification [Adulteration, 402(a)(4)]."

OASIS charge code - NEEDS ACID

4. Inadequate - PROC "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing [Adulteration, 402(a)(4)]."

OASIS charge code - INSANITARY