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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 540.275 Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of the Organism Escherichia Coli

 

REGULATORY ACTION GUIDANCE:

  1. The following represents criteria for recommending direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct issuance of a Section 305 notice by District Offices:

  2. When upon examination of an objective sample consisting of a minimum of 6 subsamples of fresh or frozen crabmeat, Escherichia coli MPN of at least 3.6 per gram (IMVIC confirmed) is found in two or more subsamples and no inspectional evidence is available to indicate the most probable source of the Escherichia coli.

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within meaning of 21 U.S.C. 342(a)(4) in that the food has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth.

NOTE: Use authority to directly issue a section 305 notice only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

  1. The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):

  2. When upon examination of an objective sample consisting of a minimum of 6 subsamples fresh or frozen crabmeat, Escherichia coli MPN of at least 3.6 gram (IMVIC confirmed) is found in one or more subsamples, and inspectional evidence is available which would indicate the most probable source of the Escherichia coli.

    Cases referred to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) will be reviewed to determine if a 21 U.S.C. 342(a)(3) charge can be supported.

*Material between asterisks is new or revised*

Issued: 10/1/82
Revised: 10/30/89, 3/95, 5/2005
Updated:  11/29/2005