CPG Sec. 570.425 Tree Nuts - Adulteration 
Involving Rejects (Insect Infestation, Moldy, 
Rancid, Otherwise Decomposed, Blanks, and 
Shriveled) 
This guidance document represents the Agency's current thinking on its enforcement 
process concerning the adulteration of tree nuts involving rejects (insect infestation, moldy, 
rancid, otherwise decomposed, blanks, and shriveled). It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the applicable statute 
and regulations. 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for recommending 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*: 
1.  Nuts in-shell and shelled nuts  
   Percentage Rejects 
   In-shell  Shelled 
Almonds  5  5 
Brazils  10  5 
Cashews  --  5 
Green chestnuts  15  -- 
Baked chestnuts  10  -- 
Dried chestnuts  --  5 
Filberts  10  5 
Pecans  10  5     Percentage Rejects 
   In-shell  Shelled 
Pistachios  10  5 
Walnuts  10  5 
Lichee nuts  15  -- 
10 
Pili nuts  15 
 
2.  Mixed nuts in-shell  
Separate each variety and recommend seizure of lot if the percentage of rejects for any variety is 
greater than the action level for that individual variety. 
Where insect infestation is involved, the above action levels are for orchard type infestation. 
Determination of reject in-shell and shelled nuts is done using the appropriate sequential 
sampling plans in Macroanalytical Procedures Manual 10.A.(4)a and b, and 10.A.(5)a and b. 
REMARKS: 
Seizure based on reject findings involving these products must be discussed with the U.S. 
Department of Agriculture. Therefore, submit the following information *by e-mail* or FAX to 
the 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 
Codes 
Analytical Conclusions 
   SPECIMEN CHARGES: 
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) in that 
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, rancid, or otherwise 
decomposed nuts; and in that it is otherwise unfit for food by reason of the presence therein of 
blanks or shriveled nuts. 
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." 
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: 11/07/79 
Reissued: 10/1/80 
Revised: 12/2/88, 3/95, 5/2005 
Updated: 11/29/05