CPG Sec 570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled)

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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 	--
Pili nuts 	15
10
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