IA#16-114, -----6/4/96 Revised
SUBJECT : "DETENTION WITHOUT PHYSICAL EXAMINATION OF
FROZEN SHRIMP IMPORTED BY SIGMA
INTERNATIONAL, INC., ST. PETERSBURG, FLORIDA"
TYPE OF ALERT : ***Detention Without Physical Examination***
Note: This alert is being revised to provide
changes to format and/or terminology and are
bracketed by asterisks (***).
***NOTE : This import alert contains guidance to FDA
field personnel only. It does not establish
any requiremnts, or create any rights or
obligations on FDA or on regulated
entities.***
PRODUCT : Frozen Shrimp
PRODUCT CODE : 16J[][]05
PROBLEM : Salmonella (FLSA)
Decomposition (MDSC)
Filth (FLNC)
PAC FOR
COLLECTION : 03844
COUNTRY : All (ZZ, 999)
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.# : N/A
IMPORTER/
CONSIGNEE : Sigma International, Inc.
333 16th Avenue S.
St. Petersburg, Florida 33701
IMPORTER'S
I.D. # : 64-0611663
CHARGE : Salmonella:
"The article is subject to refusal of
admission pursuant to Section 801(a)(3) in
that it appears to contain Salmonella, a
poisonous or deleterious substance which may
render it injurious to health [Adulteration,
Section 402(a)(1).]"
and
Filth, Decomposition:
"The article is subject to refusal of
admission pursuant to Section 801(a)(3) in
that it appears to consist in whole or in
part of a filthy, putrid, or decomposed
substance, namely that it appears to contain
rodent filth, insect filth, and
decomposition, among other substances
[Adulteration, Section 402(a)(3).]"
RECOMMENDING
OFFICE : ORL-DO (HFR-SE240)
REASON FOR
ALERT : Orlando district has documented the following
import practices of Sigma International
related to frozen shrimp:
1. Repeatedly importing violative products.
Recently three shipments of shrimp were
sampled by FDA and found violative for
decomposition. All three shipments were
submitted for seizure. In addition, FDA
analysis of a shipment of shrimp
imported by Sigma, identified with
sample number 1893130, found the product
violative for filth (cockroach excreta,
human hair). Another shipment imported
by Sigma, identified with sample number
1893171, was subject to ***detention
without physical examination*** because
of Salmonella, filth, and decomposition.
The entry documents submitted with that
shipment failed to correctly identify
the source of the shrimp as being
shipped by a firm on ***detention
without physical examination.***
2. Submitting entry documents that do not
correctly identify the manufacturer or
shipper. In the cases cited above (FDA
sample numbers 1893130 and 1893171), the
entry documents incorrectly listed
packers that were not subject to
***detention without physical
examination*** at the time of entry.
The actual packers of the products were
subject to ***detention without physical
examination*** under Import Alert #16-
35, "Fresh and Frozen Shrimp from
India."
Orlando district has identified three
shipments of shrimp imported by Sigma
which have recently been submitted for
seizure because of decomposition (see
above). All three lots were entered
through Los Angeles district and the
entry documents identified firms other
than the actual packers (who were
subject to ***detention without physical
examination***). This resulted in Los
Angeles district releasing, rather than
***detaining without physical
examination***, the shipments. Prior to
accomplishments of the seizures, Sigma
made continued attempts to sell the
decomposed shrimp which has been
partially or totally rejected by eight
consignees and the National Marine
Fisheries Service (NMFS).
3. Laboratory Shopping (i.e., sending
samples of products ***detained without
physcal examination*** to different
private labs and then submitting to FDA
only the analyses that show the product
to be in compliance, even though another
lab found the product violative.)
Orlando district has documented this
practice for at least two entries, where
one laboratory found the entries
violative for Salmonella and Sigma only
submitted results from a laboratory that
obtained negative results. Due to this
practice it is difficult to determine
whether the appearance of a violation in
Sigma entries has been overcome.
4. There has been an abrupt drop-off of
entries by Sigma in Orlando district
ports since February 1994. The firm may
be entering products through other ports
and/or under alternate names. Recent
entries of frozen shrimp through Los
Angeles have reportedly identified other
firms, such as a bank, as the importer
of record.
Based on the above shrimp imported by Sigma
appears violative for filth, decomposition,
and Salmonella. Further the source of the
shrimp may not be properly identified on the
shipping documents, permitting the shipments
to avoid ***detention without physical
examination*** and/or close scrutiny by FDA.
GUIDANCE : ***Districts may detain, without physical
examination*** all shipments of frozen shrimp
imported by, consigned to, or invoiced to
Sigma International, Inc., St. Petersburg,
Florida. Because of the recent reported use
of firms such as banks as the importer of
record for frozen shrimp, entry documents
should be closely reviewed to determine
whether a relationship exists with Sigma.
NOTE: At the request of FDA, USCS has
implemented ACS screening criteria placing
all shrimp from Sigma (and related firms) on
intensive examination. We have requested
that local USCS officials notify their local
FDA counterparts whenever a shipment from
Sigma is encountered. Upon notification,
districts should check EEPS records to
determine the status of the shipment.
Districts should request paper documentation
for shipments identified for review. If a
May Proceed notice has been authorized by
EEPS, districts must immediately notify the
filer that a May Proceed notice was issued in
error and request paper documentation for FDA
review. Districts must then notify their
local USCS official so that the intensive
examination requirement can be rescinded.
Because of the documented practice of
"laboratory shopping" by Sigma, districts are
advised that samples collected directly by
Sigma and submitted to a private laboratory
for analyses should not be considered
sufficient to remove the appearance of a
violation. Therefore, where Sigma seeks to
overcome the appearance of a violation, by
submitting laboratory analysis, third party
sampling should be used. In addition,
procedures should be implemented to assure
that only one sample is collected for private
laboratory analysis.
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Shrimp, Sigma, Decomposition, Filth,
Salmonella
PREPARED BY : Doug Randes, DIOP, 301-443-6553.
|
