CPG Sec 525.625 Whole and Ground Pepper - Adulteration with Insect & Rodent Filth; Mold; Mammalian Excreta; Foreign Matter

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

Office of Inspections and Investigations

Human Foods Program

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

REGULATORY ACTION GUIDANCE:

1. 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*:

Whole Pepper

a. Insect Filth and Mold

The pepper contains an average of 1% or more insect infested and/or moldy pieces by weight.

b. Mammalian Excreta

The pepper contains an average of 1 milligram or more of mammalian excreta per pound.

c. Foreign Matter

The pepper contains an average of 1% or more pickings and siftings by weight.

2. The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):

Ground Pepper

a. Insect Filth

The ground pepper in six or more subsamples contains an average of 475 or more insect fragments per 50 grams.

b. Rodent Filth

The ground pepper in six or more subsamples contains an average of 2 or more rodent hair fragments per 50 grams.

REMARKS:

Since the majority of spices are imported, determine that the lot in question has not been previously examined and released by FDA as an import. If the lot has been examined and released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for seizure consideration in the usual manner.

SPECIMEN CHARGE:

Article (whole/ground pepper) adulterated (when introduced into and while in interstate commerce) (while held for sale after shipment in interstate commerce), within 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), (insect webbing), (insect excreta), (insect fragments), (insect damaged pepper), and (mammalian excreta), (rodent hairs); and that it consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed pepper); and is unfit for food by reason of presence therein of (stones), (clay), and (sand); or 342(b)(2) in that (stones), (clay), and (sand) have been substituted wholly or in part for (whole/ground) pepper.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 2/1/86, 3/95, 5/05

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. 525.625 Whole and Ground Pepper -
Adulteration with Insect & Rodent Filth; Mold;
Mammalian Excreta; Foreign Matter
REGULATORY ACTION GUIDANCE:
1. 	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*:
Whole Pepper
a. 	Insect Filth and Mold
The pepper contains an average of 1% or more insect infested and/or moldy pieces by weight.
or
b. 	Mammalian Excreta
The pepper contains an average of 1 milligram or more of mammalian excreta per pound.
or
c. 	Foreign Matter
The pepper contains an average of 1% or more pickings and siftings by weight.
2. 	The following represents criteria for recommending legal action to CFSAN/Office of
*Compliance*/Division of Enforcement (HFS-605):
Ground Pepper
a. 	Insect Filth
The ground pepper in six or more subsamples contains an average of 475 or more insect
fragments per 50 grams.
or
b. 	Rodent Filth

The ground pepper in six or more subsamples contains an average of 2 or more rodent hair
fragments per 50 grams.
REMARKS:
Since the majority of spices are imported, determine that the lot in question has not been
previously examined and released by FDA as an import. If the lot has been examined and
released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of
Enforcement (HFS-605) for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (whole/ground pepper) adulterated (when introduced into and while in interstate
commerce) (while held for sale after shipment in interstate commerce), within 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), (insect webbing), (insect excreta), (insect fragments), (insect damaged
pepper), and (mammalian excreta), (rodent hairs); and that it consists in part of a decomposed
substance by reason of presence therein of (moldy, decomposed pepper); and is unfit for food by
reason of presence therein of (stones), (clay), and (sand); or 342(b)(2) in that (stones), (clay), and
(sand) have been substituted wholly or in part for (whole/ground) pepper.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95, 5/05
Updated: 11/29/05

CPG Sec 525.625 Whole and Ground Pepper - Adulteration with Insect & Rodent Filth; Mold; Mammalian Excreta; Foreign Matter

Submit Comments

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