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. Insect Filth
a. The chocolate in six (6) 100 gram subsamples contains an average of 60 or more insect fragments per 100 grams.
b. Any one subsample contains 90 or more insect fragments, even if the overall average of all the subsamples is less than 60.
2. Rodent Filth
a. The chocolate in six (6) 100 gram subsamples contains an average of more than 1.0 rodent hair per 100 grams, regardless of the size of the hairs or hair fragments.
b. Any one subsample contains more than 3 rodent hairs even if the overall average is less than 1.0 rodent hair.
*NOTE: Insect and rodent filth analyses are conducted using method 965.38, Official Methods of Analysis, (2000) 17th Edition, AOAC, Gaithersburg, MD.*
Article adulterated (when introduced into and while in interstate commerce) (while held for sale after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a filthy substance by reason of the presence therein of (insect fragments) (rodent hairs).
NOTE: Only use direct reference citation authority 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.*
Revised: 3/95, 8/96, 8/2000
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.