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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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 (1) direct reference seizure to the Division of Compliance Management and Operations (HFC-210), (2) direct reference citation and (3) detention of imported products by District Offices:

  1. 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).
  2. 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.
  3. 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manual and this Compliance Policy Guide cannot always be arranged and there may be times when the manual contains an outdated plan.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.

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TABLE I
Sequential Analysis Plan for Dates
 
Number of Defective Dates
Number of
Dates Examined1
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.*

 

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TABLE II
SAMPLE COLLECTION CRITERIA
  1. 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.
  2. Determine number of subsamples to collect on the basis of lot size from the following chart:
NUMBER OF CONTAINERS1 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