Compliance Policy Guide
Compliance Policy Guidance for FDA StaffCHAPTER - 5
SUB CHAPTER - 510
Sec.570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation,
Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05)
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:
1. Nuts in-shell and shelled nuts
The nuts contain rejects (insect infested, moldy, rancid, otherwise decomposed, blanks,
and shriveled) above the following action levels:
|
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 |
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 via EMS or
FAX to the* *CFSAN/Office of Field Programs/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:
- 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.*
Issued: 11/07/79
Reissued: 10/1/80
Revised: 12/2/88, 3/95
Page, table formatted, & spelling corrected: 10/23/2001 tc |