REGULATORY ACTION GUIDANCE:
The following represents the criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605).
Where samples are analyzed in accordance with applicable methods of the current Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC) and supplements and all of the following analytical conditions are met:
- Original and check analysis show aflatoxins above 20 mcg/kg (20 ppb),
- Identity of aflatoxin B1 is confirmed by chemical derivative formation,
- Identity of aflatoxin B1 is confirmed by negative ion chemical ionization mass spectrometry (required for all commodities covered by this Guide except corn and corn meal, cottonseed meal, coconut meal, copra, and pumpkin seed).
When the original analysis shows total aflatoxins at or above the 100 mcg/kg (100 ppb) level, lots of foods may be detained pending check and confirmatory analysis, otherwise follow criteria above.
When the original analysis shows the product contains 100 mcg/kg (100 ppb) or more of total aflatoxins, the dealer may be asked to hold the lot pending check and confirmatory analysis.
NOTE: Brazil nuts, pistachios, raw peanuts, and peanut products are covered by separate guides.
*Material between asterisks is new or revised*
Revised: 4/1/81, 3/1/83, 3/95, 5/2005
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.