Updated: 2005-11-29
Sec. 540.275 Crabmeat - Fresh and Frozen -Adulteration with Filth, Involving the
Presence of the Organism Escherichia coli (CPG 7108.02)
REGULATORY ACTION GUIDANCE:
- 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:
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.
- The following represents criteria for recommending legal action to
CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
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