Updated: 2005-11-29
Sec. 550.300 Dates and Date Material; Imported and Domestic - Adulteration
Involving Mold, Insect Excreta, Sour, Dirty, Worthless, and Pits (CPG 7110.09)
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:
- 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).
- 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.
- 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:
- One or more subs contain 10 or more dead insects (whole or equivalent);
or
- The dates contain an average of 5 or more dead insects (whole or equivalent)
per 100 grams;
or
- 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:
- 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be arranged and there may be times when the manual contains an outdated plan.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.
- 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:
- USDA findings on a lot are not accepted by FDA.
- A lot of dates, previously
declared for processing and subsequently detained by FDA, might be reentered
for packaging or other purposes.
SPECIMEN CHARGE:
- 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.
- 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 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.* |
TABLE II |
SAMPLE COLLECTION
CRITERIA |
- Random sample all lots of:
- Whole Dates, 70 pounds or less, or declared for use in processing.
- 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.
- 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