Updated: 2005-11-29
REGULATORY ACTION GUIDANCE - DOMESTIC:
The following represents criteria for direct reference seizure to *the Office of
General Counsel* through Division of Compliance Management and Operations
(HFC-210) and for direct citation by district offices of foods for human consumption
if the foods are not reconditioned by sampling, when one of the following conditions
is met:
NOTE: Refer to Sec. 690.600 (for CPG 7126.38) for guidance regarding rodent contamination of pet food. All animal food cases involving insect, rodent or bird 402(a)(3), or 402(a)(4) contamination should be referred to Division of Compliance, CVM (HFV-236) for concurrence.
NOTE: The criteria involving dead insects only should not be used to seize any food if the food will undergo further processing which will effectively remove all the dead insects present (For example: cocoa beans).
NOTE: Some live insects must be present. Product need not be shown to have become contaminated.
If product is in permeable containers (paper, cloth, burlap, etc.), and
NOTE: Bird excreta must in all instances be confirmed by positive test for uric acid.
REMARKS:
When the evidence clearly shows contamination after receipt in interstate
commerce, and a 342(a)(4) charge is made, insert the following sentence at the end
of the “Examination shows …” paragraph:
“The evidence does not show article was adulterated when introduced into interstate commerce.” If there is doubt whether the adulteration occurred before or after shipment, omit this sentence but still charge that the article was adulterated while held for sale after shipment in interstate commerce. If the evidence shows that rodents have gnawed through all layers of some of the bags and into the food, charge 342(a)(3), as shown in the attached specimen charge. If the gnawing is not shown to be all the way through the bags, then show in the Examination paragraph that the article is held in rodent-gnawed bags and charge under 342(a)(4) only. Likewise, if rodent urine, rodent excreta pellets, bird excreta or insects are observed in the food itself, charge 342(a)(3). If they are observed on the outsides of the bags but cannot be found in the food, show in the Examination paragraph that the article is held in bags contaminated with rodent urine, rodent pellets or bird excreta, or in insect-infested bags, and charge under 342(a)(4) only.
SPECIMEN CHARGE:
Article adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C., as follows:
or
Article adulterated while held for sale after shipment in interstate commerce, within
the meaning of 21 U.S.C. 342(a)(4) in that it has been held under insanitary
conditions whereby it may have become contaminated with filth.
CRITERIA FOR PROSECUTION:
NOTE: This authority is delegated to the District Director or in his absence to the
authorized Acting Director and may not be re-delegated.
REMARKS:
If the firm or any individual included in the prosecution recommendation has been
previously prosecuted for violation of the Federal Food, Drug, and Cosmetic Act, a
second offense must be charged (by indictment) if the case is referred directly to
General Counsel. If the district thinks a second offense should not be charged the
case should not be referred to General Counsel but should be forwarded to
CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) in the usual
manner.
There will, of course, be cases which do not meet the above criteria but which will warrant prosecution. In such cases, if the district thinks prosecution is warranted, forward all information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) by the usual procedure for recommending prosecution.
REGULATORY ACTION GUIDANCE - IMPORT:
Detain import foods on the basis of the domestic criteria in this guideline only when
associated with insanitary storage conditions on the dock, except for live insects.
NOTE: Mites, aphids, psocids, and thrips must be reported separately from usual storage insect contamination and are not applicable to this CPG.
Live Insect Contamination
Detain whether or not the present storage facility is insect infested if the product contains:
NOTE: Where there are insanitary storage conditions on the dock or live infestation in or on the product, disregard any existing DAL or other guidelines level for the product. When field insect filth (other than live insects) is found in a product, use the defect action levels (DALs) to determine whether or not to detain the shipment. If there is no applicable DAL for the specific product in question or the evidence suggests stored product insect filth, facsimile worksheets to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) to determine if detention action should be taken.
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 7/1/83, 3/1/86, 3/95, 8/96, 5/2005