CPG Sec 550.100 Apple Butter - Adulteration with Mold; Rodent Filth, Insect

us-fda-guidance-72ada78ff9dfcbae0ead7ca483d229afCPG Sec 550.100 Apple Butter - Adulteration with Mold; Rodent Filth, InsectGuidance

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Issued by:
Guidance Issuing Office
Human Foods Program
Office of Inspections and Investigations

Manual of Compliance Policy Guides Chapter 5 - Food, Colors, and Cosmetics

REGULATORY ACTION GUIDANCE:

The following represents the 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*:

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. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/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, 5/2005 Updated: 11/29/05


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

CPG Sec. 550.100 Apple Butter - Adulteration
with Mold; Rodent Filth, Insect
REGULATORY ACTION GUIDANCE:
The following represents the 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*:
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. *E-
mail* or FAX the following information to CFSAN/Office of *Compliance*/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, 5/2005
Updated: 11/29/05

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