CPG Sec 550.300 Dates and Date Material; Imported and Domestic - Adulteration Involving Mold, Insect Excreta, Sour, Dirty, Worthless and Pits

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CPG Sec. 550.300 Dates and Date Material;
Imported and Domestic - Adulteration Involving
Mold, Insect Excreta, Sour, Dirty, Worthless
and Pits
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*, direct reference citation requests, and detention of
imported products by the appropriate *Field Office within the Human and Animal Food
Program*:
A. Dates - (Whole or Pitted) - Mold, dead insects, insect excreta, sour, dirty and worthless
(e.g., mite infested, immature, grossly fibrous or woody, etc.) dates.
The sample (collected according to criteria in Table II), examined in accordance with the
sequential analysis plan of Table I, shows a number of reject dates that meets or exceeds the
indicated reject number.
See FDA Technical Bulletin Number 5, Macroanalytical Procedures Manual, pages V-53
through V-58 for (1) definitions of reject dates, (2) methodology for determining rejects, and (3)
reporting requirements (including findings chart).
B. Pitted Dates - Pits
The dates contain an average of 2 or more pits and/or pit fragments 2 mm or longer measured in
the longest dimension per 100 dates.
C. Date Material (Chopped, Sliced or Macerated) - Dead Insects, Pits
Examination of 100 gram representative portions from each subsample collected according to
procedures in Table II, shows the following:
1. 	One or more subs contain 10 or more dead insects (whole or equivalent);
or
2. 	The dates contain an average of 5 or more dead insects (whole or equivalent) per 100
grams;
or

3. 	The dates contain an average of 2 or more pits and/or pit fragments 2 mm or longer
measured in the longest dimension per 900 grams.
REMARKS:
1. 	Methodology
FDA Technical Bulletin Number 5, Macroanalytical Procedures Manual, is published and
distributed by an organization outside of FDA. As a result, simultaneous revision of both the
manual and this Compliance Policy Guide cannot always be arranged and there may be times
when the manual contains an outdated plan. Therefore, if the manual plan (on page V-56, section
(4)(b)) differs from the plan in Table II of this guide use the plan in this guide in lieu of the
manual plan.
2. 	Imports
According to the current agreement *(MOU, FDA 225-72-2001,* signed 11/19/85) with USDA,
FDA will examine date material, dates declared for processing, and those dates that are packaged
or declared for packaging in lots of 70 lbs. or less. USDA will examine packaged dates or dates
declared for packaging in lots of over 70 lbs.
Notify the appropriate USDA field office when:
1. 	USDA findings on a lot are not accepted by FDA.
2. 	A lot of dates, previously declared for processing and subsequently detained by FDA,
might be reentered for packaging or other purposes.
SPECIMEN CHARGE:
1. 	Pits:
Article adulterated when introduced into and while in interstate commerce within the meaning of
*21 U.S.C. 342(b)(2),* in that a substance, namely pits, has been substituted in part for pitted
dates.
2. 	Insects, Moldy, Sour, Decomposed, Worthless:
Article adulterated (when introduced into and while in interstate commerce) (while held for sale
after shipment in interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it
consists in part of a (filthy) (decomposed) substance by reason of the presence therein of
(insects/insect fragments/insect excreta) (moldy/sour/decomposed/worthless dates).
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.

TABLE I
Sequential Analysis Plan for Dates
Number of Defective Dates
Number of
Dates Examined 1 	Accept (at or below) 	Continue Analysis 	Reject (at or above)
100 	1 	2-7 	8
200 	5 	6-12 	13
300 	10 	11-17 	18
400 	14 	15-21 	22
500 	18 	19-25 	26
600 	23 	24-30 	31
700 	27 	28-34 	35
800 	34 	- 	35
*1Product is to be selected at random and as nearly equal in number as practical from each
subsample in the sample.*

Sequential Analysis Plan for Dates
Number of Defective Dates
Number of
Dates Examined 1 	Accept (at or below) 	Continue Analysis 	Reject (at or above)

TABLE II
SAMPLE COLLECTION CRITERIA
A. Random sample all lots of:
1. 	Whole Dates, 70 pounds or less, or declared for use in processing.
2. 	Date Material (chopped, sliced and macerated dates) being submitted for entry.
NOTE: See Investigations Operations Manual, Subsection *427.04(c) and
536.01* for examining and reporting on live insect infestation.
B. Determine number of subsamples to collect on the basis of lot size from the following
chart:
NUMBER OF CONTAINERS 1 IN THE LOT
Number of Containers In the Lot
Number of Subsamples Required
Whole Dates 	Date Material
100 or less 	3 	4
101-600 	8 	6
601-1200 	14 	8
1201-2000 	26 	10
2001-2800 	36 	12
2801-6000 	44 	14
6001-9600 	56 	16
9601-15000 	68 	18
Over 15000 	82 	22
1 NOTE: Chart is based upon unit containers weighing between 20 pounds and 100 pounds.
Should containers exceed 100 pounds, consider as 2 or more containers. For example, a 150-
pound container would be 2 containers and a 300-pound container, 3 containers.
C. Each subsample should consist of 300-400 dates or a 3-pound chunk. Bag subs separately
and identify.
* Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 11/1/81, 5/1/83, 2/1/86, 6/1/86, 5/2005
Updated: 11/29/05