Import Alert 16-07
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 16-07
Published Date: 02/24/2022
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Dried or Pickled Finfish from Thailand"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 02/23/2022 updates the guidance, agency contacts, charge code language, and product description. Changes to the import alert are bracketed by asterisks (***).
During the six month period from October 27, 1982, through April 27, 1983, 10 out of 16 samples of pickled fish from Thailand were detained (a 62% detention rate) for insect and rodent filth.
During the six month period from September 1, 1984, through February 28, 1985, 13 out of 24 samples of dried fish from Thailand were detained (a 54% detention rate) for insect, rodent, bird and/or cat filth, in addition to mold, decomposition, and violative labeling.
During the six month period from October 27, 1982, through April 27, 1983, 10 out of 16 samples of pickled fish from Thailand were detained (a 62% detention rate) for insect and rodent filth.
During the six month period from September 1, 1984, through February 28, 1985, 13 out of 24 samples of dried fish from Thailand were detained (a 54% detention rate) for insect, rodent, bird and/or cat filth, in addition to mold, decomposition, and violative labeling.
Guidance:
*** Divisions may detain, without physical examination, all shipments of dried or pickled finfish from Thailand, except those listed on the Green List of this alert. ***
This import alert does not cover other dried marine products such as dried shrimp. It does, however, cover fish preserved by other methods which include essentially the same ingredients as pickled fish.
*** Release of Articles Subject to Detention Without Physical Examination Under this Import Alert:
Products covered under this import alert may also be subject to DWPE under Import Alert 16-74, "Detention Without Physical Examination of Uneviscerated Fish or Partially Eviscerated Fish that are Either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (i.e., excluding LACF and Acidified Products Filed Under 21 CFR 108/113 or 114)." Please refer to import alert 16-74 for additional information. ***
In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the responsible party for the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. The evidence submitted should demonstrate compliance of the article in that the product does not appear to contain unacceptable levels of filth.
The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation:
1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses;
2. Each sample should consist of:
• 10 subsamples, containing one pound (1 lb.) per subsample;
or,
• 10 subsamples per lot of consumer sized packages containing up to one pound (1 lb.)
Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
*** Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):
When dried or pickled fish are uneviscerated and also subject to Import Alert 16-74, they must first be removed from the Red List of Import Alert 16-74 prior to addition to the Green List for Import Alert 16-07. Refer to Import Alert 16-74 for information regarding the products covered and evidence to be submitted for removal from DWPE. ***
*** Additionally, *** in order to remove a firm from detention without physical examination from this import alert, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forward to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
*** Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues on human food policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov
***
This import alert does not cover other dried marine products such as dried shrimp. It does, however, cover fish preserved by other methods which include essentially the same ingredients as pickled fish.
*** Release of Articles Subject to Detention Without Physical Examination Under this Import Alert:
Products covered under this import alert may also be subject to DWPE under Import Alert 16-74, "Detention Without Physical Examination of Uneviscerated Fish or Partially Eviscerated Fish that are Either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (i.e., excluding LACF and Acidified Products Filed Under 21 CFR 108/113 or 114)." Please refer to import alert 16-74 for additional information. ***
In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the responsible party for the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. The evidence submitted should demonstrate compliance of the article in that the product does not appear to contain unacceptable levels of filth.
The responsible parties should use the following information as a template when submitting third party sampling and private lab analytical results in an attempt to overcome the apparent violation:
1. Samples should be collected by a third party and tested by a private laboratory qualified in the analyses;
2. Each sample should consist of:
• 10 subsamples, containing one pound (1 lb.) per subsample;
or,
• 10 subsamples per lot of consumer sized packages containing up to one pound (1 lb.)
Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
*** Removal from Detention without Physical Examination (ADDITION TO THE GREEN LIST):
When dried or pickled fish are uneviscerated and also subject to Import Alert 16-74, they must first be removed from the Red List of Import Alert 16-74 prior to addition to the Green List for Import Alert 16-07. Refer to Import Alert 16-74 for information regarding the products covered and evidence to be submitted for removal from DWPE. ***
*** Additionally, *** in order to remove a firm from detention without physical examination from this import alert, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forward to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
*** Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov
Questions or issues on human food policy, sample collection recommendations, or other any addition questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov
***
Product Description:
Dried or Pickled Finfish
Charge:
***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 or be otherwise unfit for food. [Adulteration, Section 402(a)(3)].***
OASIS charge code: FILTHY
OASIS charge code: FILTHY
Countries
THAILAND
-
(16 A - H --) Fish, Ntrl/Artfcl Dried
-
(16 A - P --) Fish, Cultured/Cured
List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)
THAILAND
Bangkok Dehydrated Marine Product Co., Ltd.
Date Published : 09/10/2009
T. Kubangluang, A. Lardloomkaew , 33; 3 MU 8 Lardloomkaew-Pathumthani Road
, Pathumthani,
THAILAND
16 A - H 01 Anchovy, Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: FROZEN DRIED ANCHOVY
Exempt - 7/20/2007
16 A - H 52 Gourmay, gourami, Ntrl/Artfcl Dried
Date Published: 09/10/2009
Desc: Frozen; Salted
Notes: "Pla Salid"
Exempt - 9/3/2003
16 A - H 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22'), Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: Frozen Salted Mackerel
Exempt - 4/11/2001
16 A - P 52 Gourmay, gourami, Cultured/Cured
Date Published: 11/30/2009
Notes: "Pla Salid"
Exempt - 9/3/2003
16 A - P 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22'), Cultured/Cured
Date Published: 09/10/2009
Notes: Frozen Salted Mackerel
Exempt - 4/11/2001
16 A - T 01 Anchovy, Packaged Food (Not Commercially Sterile)
Date Published: 07/02/2021
Desc: FROZEN DRIED ANCHOVY
Notes: Exempt - 7/20/2007
Kibun (Thailand) Co., Ltd.
Date Published : 09/10/2009
31/10 Muangsakul 2 Alley
, Mueang Samut Sakhon,
Samut Sakhon THAILAND
16 A - H 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22'), Ntrl/Artfcl Dried
Date Published: 09/10/2009
Notes: Dried Mackeral
Exempt - 7/24/2002
16 A - P 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22'), Cultured/Cured
Date Published: 09/10/2009
Notes: Vinegared Mackeral
Exempt - 6/22/2005
Natural Sea Product Co.,Ltd.
Date Published : 12/17/2012
29/6 Moo 3, Tambol Bangyapak
, Mueang Samut Sakhon,
Samut Sakhon THAILAND
16 A - H 01 Anchovy, Ntrl/Artfcl Dried
Date Published: 12/17/2012
Desc: Dried Anchovy
16 A - H 92 Trevally, Ntrl/Artfcl Dried
Date Published: 12/17/2012
Desc: Dried Yellow Stripe Trevally
16 A - H 99 Fish, N.E.C., Ntrl/Artfcl Dried
Date Published: 12/17/2012
Desc: Dried Pupple Spotted Bigeye
16 A - H 99 Fish, N.E.C., Ntrl/Artfcl Dried
Date Published: 12/17/2012
Desc: Dried Saurida
T K C Food Co Ltd aka Thai Pickled Fish Co Ltd
Date Published : 09/10/2009
39 13 Moo 6 Tachine Amphor Mueng (fact) , 61 83 Senanikorn 1 Bangkapi Bangkok (off
, Samutsakorn,
THAILAND
16 A - H 52 Gourmay, gourami, Ntrl/Artfcl Dried
Date Published: 11/30/2009
Notes: Preserved Gouramy Fish
Exempt - 10/30/1992
16 A - P 52 Gourmay, gourami, Cultured/Cured
Date Published: 12/01/2009
Notes: Preserved Gouramy Fish
Exempt - 10/30/1992