Insanitary practices and processing conditions in food plants usually result in an increase in the number of microorganisms in the food being processed. To determine the extent to which an increase in the level of microorganisms could be attributed to the manufacturing process for breaded shrimp, a survey was conducted in FY'78 of 31 shrimp breader plants that were determined to be utilizing current good manufacturing practices in their operations. The results of that survey were used as a basis for establishing microbiological criteria that could be used to objectively evaluate compliance with current good manufacturing practice regulations.
REGULATORY ACTION GUIDANCE:
The following represent criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
- Aerobic Plate Counts (35oC) - The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 5.00 (i.e., geometric mean greater than 100,000/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their difference (2 SED),
- Escherichia coli - The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 0.56 (i.e., geometric mean greater than 3.6/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their difference (2 SED),
- Staphylococcus aureus - The mean log of 16 units of finished product breaded shrimp collected prior to freezing is greater than 2.00 (i.e., geometric mean greater than 100/g) and exceeds the mean log of 16 units of stock shrimp by more than twice the standard error of their difference (2 SED).
The criteria in this Guide do not apply to breaded shrimp that are precooked by the processor.
Microbiological criteria specified in this Guide are based on a statistically designed plan involving the collection of subsamples at the beginning and end of the breaded shrimp manufacturing process. The raw shrimp collected from the first location on the processing line are considered "stock" shrimp. When frozen raw shrimp are used for processing, samples of stock shrimp should be collected after thawing.
To determine compliance with these criteria, in-plant sampling during inspection of the shrimp breading operation should include the following:
- Duplicate subsamples of stock shrimp collected four times a day for each of two days at intervals appropriately spaced to cover the plant's production day (16 subs).
- Duplicate subsamples of finished product collected prior to freezing four times a day for each of two days at intervals appropriately spaced to cover the plant's production day (16 subs).
- Representative subsamples of raw material other than shrimp used in processing the breaded shrimp.
Each subsample should be analyzed for aerobic plate count (35oC), Escherichia coli (MPN), and Staphylococcus aureus (surface plating method) according to current AOAC methods. The results of analysis of stock shrimp and the finished product shrimp will be used to determine whether the actionable criteria in this Guide have been met. The results of analysis of the representative subsamples of raw materials other than shrimp should be reviewed to determine whether any of them are a potential source of contamination found in the finished product raw breaded shrimp.
*Material between asterisks is new or revised.*
Revised: 10/30/89, 3/95, 5/2005
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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