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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 570.500 Pistachio Nuts - Aflatoxin Adulteration November 2005

Final
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs

At the request of spokesmen for the importers of pistachio nuts and with concurrence by FDA and USDA *(MOU, FDA 225-96-2003),* USDA will carry out the sampling and aflatoxin testing for imported pistachio nuts. Neither USDA nor FDA has a formal agreement with the pistachio importers and the program will be conducted on a voluntary basis. This program does not preclude sampling by field offices an objective basis. When sampling on an objective basis, notify USDA of pistachio nuts being detained.

Domestic and imported pistachio nuts will be analyzed for aflatoxin in accordance with the applicable methods outlined in the current edition of the Official Methods of Analysis of the Association of the Official Analytical Chemists and supplements (at the time of this transmittal, Fourteenth Edition, section 26.067 or 26.068).

NOTE: Also refer to Sec. 570.425, Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks and Shriveled). Determination of a violation based on reject criteria set forth in Sec. 570.425 may alleviate the necessity to conduct a chemical analysis for aflatoxin.

In-Shell Lots (Domestic and Import)

Shell and Kernel Analysis: The entire sample, shells and kernels, is ground and examined by the applicable method. Aflatoxin content will be calculated on a kernel weight basis.

Shelled Lots (Domestic and Import)

The entire sample, including kernels which are obviously inedible, is ground and examined by the applicable method.

REGULATORY ACTION GUIDANCE:

The following represent the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):

Lots in Domestic Status

Recommend legal action when:

1. Original and check analysis show aflatoxin above 20 ppb;

and

2. Identity of aflatoxin B1 is confirmed by chemical derivatives.

NOTE: When the original analysis shows 100 ppb or more of aflatoxin, the dealer may be asked to hold the lot pending check and confirmatory analysis.

Imports - Detention

Detain when the original and check analysis show aflatoxin above 20 ppb.

NOTE: The sample must be of sufficient size to provide for the confirmatory test should it become necessary.

*Material between asterisks is new or revised*

Issued: 10/1/82 Revised: 5/15/86, 3/95, 5/2005 Updated: 11/29/05


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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