The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
Examine a minimum of 12 subsamples. The dried peas or dried beans contain an average of 5% or more by count insect infested and/or insect damaged (storage insects) peas or beans.
If there is reason to believe the lot was graded and certified by the U.S. Department of Agriculture, submit the following information *by e-mail* or FAX to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Date of Shipment
Amount of Lot
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 the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects and/or insect damaged beans.
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.”
The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
Refer for seizure action, accompanied by exhibits, all samples from lots in consumer-size packages which contain sharp and jagged rocks even if the amount of these rocks is below the limit in the USDA grade.
*Material between asterisks is new or revised.*
Issued: 11/21/79 Reissued: 10/1/80 Revised: 12/8/88, 3/95, 5/2005 Updated: 11/29/05
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)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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