REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure*request 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*:
1. Unshelled Peanuts
The unshelled peanuts contain an average of 10% or more reject peanuts (insect infested; moldy; rancid; otherwise decomposed; blanks, and shriveled) when examined by Macroanalytical Procedures Manual 10.B.(4).
2. Shelled Peanuts a. The peanut kernels average 5% or more reject kernels (insect infested, moldy, rancid, otherwise decomposed, and dirty); when examined by Macroanalytical Procedures Manual 10.B.(5)a.
b. The shelled peanuts contain an average of 20 or more whole insects or equivalent per whole bag siftings (100 pound bag basis) when examined by Macroanalytical Procedures Manual 10.B.(5)a.
For live insects refer to Compliance Policy Guide because of reject nuts must be discussed with 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:
Sample Number Date of Shipment Article Involved Dealer Amount of Lot Shipper Code Analytical Conclusions
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) since it consists in part of a filthy substance by reason of the presence therein of insects; of a decomposed substance by reason of the presence therein of moldy and decomposed peanuts; or in that it is otherwise unfit for food by reason of the presence therein of shriveled nuts and empty shells.
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."
3. Use direct citation authority 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.
*Material between asterisks is new or revised.*
Issued: 11/7/79 Reissued: 10/1/80 Revised: 12/2/88, 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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Rockville, MD 20852
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