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:
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 |
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:
*Material between asterisks is new or revised.*
Issued: 11/07/79
Reissued: 10/1/80
Revised: 12/2/88, 3/95, 5/2005