REGULATORY ACTION GUIDANCE:
The following represents criteria for 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. If examination of the frozen eggs or frozen egg products by a qualified egg examiner shows two or more cans contain decomposed eggs;
2. At least two subsamples, but all subsamples if more than two are examined, from cans classed as decomposed have direct microscopic counts of 5,000,000 or more bacterial cells per gram when analyzed by AOAC 940.37, 15 Ed.
If all cans in the lot are examined, recommend seizure only of the cans found to contain decomposed eggs.
If there is reason to believe that the lot of egg products was packed under the supervision of or certified by the U.S. Department of Agriculture, submit the following information *by e-mail* or FAX to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Amount of Lot
Date of Shipment
Article adulterated when introduced into and while in interstate commerce, within the meaning of 21 U.S.C. 342(a)(3) in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed eggs.
*Material between asterisks is new or revised.*
Issued: 10/1/80 Revised: 3/95, 8/96, 5/2005 Updated: 11/29/2005
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.