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;

and

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.

REMARKS:

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:

Sample Number

Article Involved

Amount of Lot

Codes

Date of Shipment

Dealer

Shipper

Analytical Conclusions

SPECIMEN CHARGE:

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