Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Sec. 550.100 Apple Butter - Adulteration with Mold; Rodent Filth, Insects (CPG 7110.01)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

A minimum of six subsamples is required for examination.

1. Mold: The apple butter has an average mold count of 12% or more;

or

2. Rodent Filth: The apple butter contains an average of 4 or more rodent hairs per 100 grams;
or

3. Insects: The apple butter contains an average of 5 or more whole or equivalent insects (not counting mites, aphids, thrips or scale insects) per 100 grams.

REMARKS:

Seizures of canned apple butter must be discussed with the U.S. Department of Agriculture. EMS or FAX the following information to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number Date of Shipment
Article Involved Dealer
Amount of Lot Shipper
Codes 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 filthy substance by reason of presence therein of insects and rodent hairs; and of a decomposed substance by reason of presence therein of decomposed apple butter.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95