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 to the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:
- 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 Pistachios 10 5 Walnuts 10 5 Lichee nuts 15 -- Pili nuts 15 10
- 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.
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:
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.
- 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."
- 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."
- 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.*
Revised: 12/2/88, 3/95, 5/2005