REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to ORA, Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

Examination of six 50 gram subsamples shows:

*

1. Insect fragments - an average of 75 or more insect fragments per 50 grams;*

or

2. Rodent Hairs - an average of 1.0 or more rodent hair per 50 grams.

*NOTE: These criteria do not apply to flour prepared from durum and/or red durum wheats.*

SPECIMEN CHARGE:

*The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) because it consists in part of a filthy substance by reason of the presence therein of insect fragments and rodent hairs.

NOTES:

1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."*

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 12/31/87