Import Alert 71-04

(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 # 71-04
Published Date: 10/04/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination Of Animal Feeds, Other Than Pet Treats, Due To The Presence Of Salmonella"

Reason for Alert:

In March, 2003, the Southwest Import District collected a sample of ovine (sheep) meat and bone meal from an Australian manufacturer in domestic status. Subsequently, the sample was analyzed and found to be contaminated with Salmonella. Although traced back to an imported shipment, it was difficult to assess whether the source of adulteration had occurred at the foreign manufacturer or at the domestic manufacturer. Subsequently, samples of feeds from other foreign manufacturers collected at entry by SWID have been found positive for Salmonella.



This import alert provides for manufacturers and shippers, from multiple countries, to be placed on detention without physical examination for animal feeds, other than pet treats, found to contain Salmonella. Pet treats are covered by Import Alert #72-03.

Guidance:

Districts may detain, without physical examination, products offered for importation from manufacturers and shippers identified in the Red List to this alert.



Report animal feed samples found positive for Salmonella to CVM, Division of Compliance, HFV-232. Refer to Compliance Program 71003, Feed Contaminants Program, for further guidance. Recommendations for detention without physical examination should be forwarded to DIOP.



For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.



To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that the firm provide the following information:



a. Results of the firms investigation(s) into the problem of Salmonella contamination



b. Documentation showing corrective action(s), such as:



i. a description of the process(es) being used

ii. verification that the process is adequate

iii. measures that have been taken to prevent recontamination



c. Copies of three (3) production records showing the process, quantities processed, lot numbers and dates of processing.



FDA personnel should assess the adequacy of the firm-s corrective process by reviewing third party analytical results for five (5) consecutive shipments, where the removal request relates to a single product, or twelve (12) consecutive shipments, where the removal request relates to multiple products.



All requests for removal from DWPE should be forwarded to DIOP

Food Drug Administration

12420 Parklawn Dr.

ELEM - 3109

Rockville Md 20857

Product Description:

Animal feeeds (see attachment)

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain Salmonella, a poisonous or deleterious substance, which may render it injurious to health, [Adulteration, Section 402(a)(1)]"



OASIS Charge code - SALMONELLA

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


AUSTRALIA


Australian Tallow Producers Pty Ltd
Date Published : 08/08/2016
680 Geelong Rd , Brooklyn, Victoria AUSTRALIA
17 Y - - 07 Ovine By-Products
Date Published: 08/22/2018

Desc: Ovine Meal

71 A - - 99 Slaughtered Mammal By Prod N.E.C.
Date Published: 08/22/2018

Desc: Ovine Meal

71 E - - 99 Animal Waste Feed Products, N.E.C.
Date Published: 08/22/2018

Desc: Ovine Meal

71 Y - - 99 Byprod For Animal, N.E.C.
Date Published: 08/08/2016

Desc: OVINE MEAL

72 B - - 01 Meat (Mammalian Muscle) Prod Pet Dog Food
Date Published: 08/22/2018

Desc: Ovine Meal

72 B - - 99 Pet Dog Food N.E.C.
Date Published: 08/22/2018

Desc: Ovine Meal

72 E - - 99 Other Pet Food, N.E.C.
Date Published: 08/22/2018

Desc: Ovine Meal

Cool Off Pty Ltd
Date Published : 12/09/2013
271 Jude Rd , Howlong, New South Wales AUSTRALIA
72 B - - 99 Pet Dog Food N.E.C.
Date Published: 12/09/2013

Desc: Beef Straps
Problems: SALMONELLA;

72 E - - 99 Other Pet Food, N.E.C.
Date Published: 12/09/2013

Desc: Beef Straps
Problems: SALMONELLA;

Rosedale Meats
Date Published : 08/21/2015
3 Swyer St , Hampton, ViC AUSTRALIA
71 A - T 06 Meat/Tankage Slaughtered Mammal By Prod, Packaged Food (Not Commercially Sterile)
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

71 A - T 99 Slaughtered Mammal By Prod N.E.C., Packaged Food (Not Commercially Sterile)
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - D 01 Meat (Mammalian Muscle) Prod Pet Dog Food, Raw - Fresh, Frozen, Natural State
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - D 99 Pet Dog Food N.E.C., Raw - Fresh, Frozen, Natural State
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - R 01 Meat (Mammalian Muscle) Prod Pet Dog Food, Irradiated
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - R 99 Pet Dog Food N.E.C., Irradiated
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - - 99 Pet Dog Food N.E.C.
Date Published: 08/21/2015

Desc: Sun Dried Kangaroo Powder

rosedale meats
Date Published : 02/09/2016
25 Oswald Thomas Ave , Hampton East, ViC AUSTRALIA
71 A - T 06 Meat/Tankage Slaughtered Mammal By Prod, Packaged Food (Not Commercially Sterile)
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

71 A - T 99 Slaughtered Mammal By Prod N.E.C., Packaged Food (Not Commercially Sterile)
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - D 01 Meat (Mammalian Muscle) Prod Pet Dog Food, Raw - Fresh, Frozen, Natural State
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - D 99 Pet Dog Food N.E.C., Raw - Fresh, Frozen, Natural State
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - R 01 Meat (Mammalian Muscle) Prod Pet Dog Food, Irradiated
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)

72 B - R 99 Pet Dog Food N.E.C., Irradiated
Date Published: 02/09/2016

Desc: Kangaroo product food pet food (Macropus Rufus/ Red Kangaroo)


CANADA


Rothsay, A Division of Darling International Canada Inc
Date Published : 06/29/2018
169 Lower Truro Rd , Truro, Nova Scotia CANADA
70 Y - - 99 Animal Feeds, N.E.C.
Date Published: 06/29/2018

Desc: Salmon Meal

71 D - - 03 Fish Meal
Date Published: 06/29/2018

Desc: Salmon Meal

Smart Nutritional Research Group Ltd.
Date Published : 10/04/2018
4781 McLeery Rd , Armstrong, British Columbia CANADA
72 B - - 02 Poultry Prod Pet Dog Food
Date Published: 10/04/2018

Desc: MAXIM CHICKEN (dehydrated raw dog food)

Soya Excel
Date Published : 09/16/2009
380 Yvon-L'Heureux Blvd S , Ss 72 , Beloeil, Quebec CANADA
70 A - - 09 Soybeans, Soybean Meal Ground Grains Animal
Date Published: 09/16/2009

Desc: Soyplus feed


CHINA


DALIAN GOODLUCK AGRICULTURAL PRODUCTS CO.,LTD
Date Published : 07/03/2018
NO. 437 Houge Street , Ganjingzi District , Dalian, Liaoning CHINA
23 K - - 01 Pumpkin Seed (Edible)
Date Published: 07/03/2018

Desc: Pumpkin Seed (Kernels)

ZUNHUA SINO TRADING CO.,LTD.
Date Published : 09/16/2009
28-1 HAINAN STREET ZUNHUA CITY , Hebei, Cn-13 CHINA
72 E - - 99 Other Pet Food, N.E.C.
Date Published: 09/16/2009

Notes: Dehydrated Celery
Problems: SALMONELLA;

72 Y - - 99 Pet/Lab Animal Food, N.E.C.
Date Published: 09/16/2009

Notes: Dehydrated Celery
Problems: SALMONELLA;


MEXICO


GALDISA SA DE CV (P3)
Date Published : 09/05/2018
Filomeno Mata 922 , Col. Santa Maria Aztahuacan, Iztapalapa , Ciudad De Mexico, MEXICO
72 C - - 99 Pet Bird Food N.E.C.
Date Published: 09/05/2018

Desc: Peanut Bird Food (raw peanuts)

GALDISA SA DE CV (P4)
Date Published : 09/05/2018
Calle Rio S. Pedro 1901 , Meoqui , Col. Villescas, Chihuahua MEXICO
72 C - - 99 Pet Bird Food N.E.C.
Date Published: 09/05/2018

Desc: Peanut Bird Food (raw peanuts)


NETHERLANDS


kroeske bv
Date Published : 01/31/2011
Helmkamp 56 , Dinxperlo, Gelderland NETHERLANDS
72 B - - -- Pet Dog Food
Date Published: 01/31/2011

Desc: Dog Food
Problems: SALMONELLA;


PERU


Industrias Bioacuaticas Talara
Date Published : 08/21/2017
Zona Industrial del km 45.3 de la Ctra. , Sullana, Paita, Distrito de Colan , Paita, Paita PERU
71 D - - 03 Fish Meal
Date Published: 08/21/2017

Desc: Squid meal


VIETNAM


Nam Hai Company Ltd.
Date Published : 09/16/2009
An Lac Ward , 279A, Kinh Duong Vuong Street , Ho Chi Minh City, Binh Tan Dist. VIETNAM
71 D - - 03 Fish Meal
Date Published: 09/16/2009

Notes: 5/22/09
Problems: SALMONELLA;