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: 04/06/2023
Type: DWPE
Import Alert Name:
Detention Without Physical Examination Of Animal Foods, Other Than Pet Treats, Due To The Presence Of Salmonella
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 04/06/2023 updates the reason for alert, guidance, agency contacts, product description and charge code language sections. Changes to the import alert are bracketed by asterisks (***).
***Certain food for animals, such as pet food, poses a significant risk to human health when contaminated with Salmonella because humans come in direct contact with these foods. Salmonella from such pet food may be ingested directly by humans from their hands or utensils that are contaminated when they feed their pets. Certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems are particularly susceptible to acquiring salmonellosis from pet food and may experience more severe symptoms. Additionally, animals may become infected, either asymptomatically or clinically, with Salmonella from the pet food, thus increasing the potential human exposure. The association between human outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established. Thus, FDA considers a pet food to be adulterated under section 402(a)(1) of the FD&C Act (21 U.S.C. § 342(a)(1)) when it is contaminated with Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.
Salmonella-contaminated animal feed (food for animals other than pet food, e.g. swine feed) can cause illness in animals that consume the feed. Whether Salmonella causes illness in such an animal depends on the serotype. Different animal species typically develop disease in response to different serotypes. Thus, FDA considers an animal food other than pet food to be adulterated under section 402(a)(1) of the FD&C Act when it is contaminated with a Salmonella serotype that is considered pathogenic to the animal intended to consume the animal food and the animal food will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.***
Samples of animal foods from foreign manufacturers, collected at entry, have been found to be positive for Salmonella.
This import alert covers animal food, other than pet treats, found to contain Salmonella. Pet treats are covered by Import Alert #72-03, "Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence Of Salmonella."
***Certain food for animals, such as pet food, poses a significant risk to human health when contaminated with Salmonella because humans come in direct contact with these foods. Salmonella from such pet food may be ingested directly by humans from their hands or utensils that are contaminated when they feed their pets. Certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems are particularly susceptible to acquiring salmonellosis from pet food and may experience more severe symptoms. Additionally, animals may become infected, either asymptomatically or clinically, with Salmonella from the pet food, thus increasing the potential human exposure. The association between human outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established. Thus, FDA considers a pet food to be adulterated under section 402(a)(1) of the FD&C Act (21 U.S.C. § 342(a)(1)) when it is contaminated with Salmonella and will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.
Salmonella-contaminated animal feed (food for animals other than pet food, e.g. swine feed) can cause illness in animals that consume the feed. Whether Salmonella causes illness in such an animal depends on the serotype. Different animal species typically develop disease in response to different serotypes. Thus, FDA considers an animal food other than pet food to be adulterated under section 402(a)(1) of the FD&C Act when it is contaminated with a Salmonella serotype that is considered pathogenic to the animal intended to consume the animal food and the animal food will not subsequently undergo a commercial heat step or other commercial process that will kill the Salmonella.***
Samples of animal foods from foreign manufacturers, collected at entry, have been found to be positive for Salmonella.
This import alert covers animal food, other than pet treats, found to contain Salmonella. Pet treats are covered by Import Alert #72-03, "Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence Of Salmonella."
Guidance:
Divisions may detain, without physical examination, shipments of the products from firms identified on the Red List of this Import Alert.
*** Compliance Policy Guide (CPG) 690.800 "Salmonella in Food for Animals" contains a risk-based framework for FDA staff deciding whether to recommend import refusal of a pet food, animal feed, or their ingredients to the Center for Veterinary Medicine.***
*** Recommendations for addition to the Red List of this Import Alert should be forwarded to the Division of Import Operations (DIO), which, when necessary, will consult with the Center for Veterinary Medicine (CVM), Division of Food Compliance, Regulatory Policy & Programs Team (HFV-236).***
Release of Articles Subject to Detention Without Physical Examination under this Import Alert:
*** In order to secure release of an individual shipment subject to DWPE under this alert, the owner, consignee, and/or another responsible party for the affected goods should provide evidence demonstrating that the product is not adulterated due to the presence of Salmonella. For pet food products, this may include providing evidence that the pet food does not contain any Salmonella serotypes.
For animal food other than pet food, the owner, consignee, and/or another responsible party for the affected goods may provide evidence demonstrating that the animal food product does not contain any Salmonella serotypes that are considered pathogenic to the intended animal(s). An example of such evidence may include private laboratory analysis of a representative sample of the shipment.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical 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 (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
*** In order to evaluate whether the firm has resolved the conditions that gave rise to the appearance of the violation, CVM may request information from those firms asking that their animal food products be removed from detention without physical examination. Examples of the type of information that CVM may request include:
1. Evidence that the firm has identified the root cause(s) of the Salmonella contamination problem and has taken corrective action(s) to prevent future occurrences.
a. Results of the firm's investigation(s) into the problem (root cause) of Salmonella contamination.
b. Documentation showing corrective action(s), such as:
i. a complete description of the manufacturing process(es) being used to address Salmonella contamination;
ii. validation of the manufacturing process(es) used to address Salmonella contamination;
iii. measures that have been taken to prevent recontamination with Salmonella within the establishment, including during packing/packaging and holding; and
iv. completion date of the corrective action(s).
c. Copies of production records generated after taking the corrective action(s), showing the process, quantities processed, lot numbers, and dates of processing.
AND
2. Evidence of non-violative shipments.
a. Requests to remove from the Red List a single product - documentation showing that a minimum of five (5) consecutive, non-violative, commercial shipments have been released based on private laboratory analyses.
b. Requests to remove from the Red List multiple products from a manufacturer - a minimum of twelve (12) non-violative shipments representative of products covered by detention without physical examination.***
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Dr, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
Requests for removal from detention without physical examination will be forwarded to CVM for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving analysis, preparation, or analytical methodology should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalert@fda.hhs.gov
Questions or issues with regard to center policy on animal food, sample collection recommendations, or any additional questions, should be addressed to CVM/Division of Food Compliance at CVMImportRequests@fda.hhs.gov
*** ***
*** Compliance Policy Guide (CPG) 690.800 "Salmonella in Food for Animals" contains a risk-based framework for FDA staff deciding whether to recommend import refusal of a pet food, animal feed, or their ingredients to the Center for Veterinary Medicine.***
*** Recommendations for addition to the Red List of this Import Alert should be forwarded to the Division of Import Operations (DIO), which, when necessary, will consult with the Center for Veterinary Medicine (CVM), Division of Food Compliance, Regulatory Policy & Programs Team (HFV-236).***
Release of Articles Subject to Detention Without Physical Examination under this Import Alert:
*** In order to secure release of an individual shipment subject to DWPE under this alert, the owner, consignee, and/or another responsible party for the affected goods should provide evidence demonstrating that the product is not adulterated due to the presence of Salmonella. For pet food products, this may include providing evidence that the pet food does not contain any Salmonella serotypes.
For animal food other than pet food, the owner, consignee, and/or another responsible party for the affected goods may provide evidence demonstrating that the animal food product does not contain any Salmonella serotypes that are considered pathogenic to the intended animal(s). An example of such evidence may include private laboratory analysis of a representative sample of the shipment.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical 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 (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
*** In order to evaluate whether the firm has resolved the conditions that gave rise to the appearance of the violation, CVM may request information from those firms asking that their animal food products be removed from detention without physical examination. Examples of the type of information that CVM may request include:
1. Evidence that the firm has identified the root cause(s) of the Salmonella contamination problem and has taken corrective action(s) to prevent future occurrences.
a. Results of the firm's investigation(s) into the problem (root cause) of Salmonella contamination.
b. Documentation showing corrective action(s), such as:
i. a complete description of the manufacturing process(es) being used to address Salmonella contamination;
ii. validation of the manufacturing process(es) used to address Salmonella contamination;
iii. measures that have been taken to prevent recontamination with Salmonella within the establishment, including during packing/packaging and holding; and
iv. completion date of the corrective action(s).
c. Copies of production records generated after taking the corrective action(s), showing the process, quantities processed, lot numbers, and dates of processing.
AND
2. Evidence of non-violative shipments.
a. Requests to remove from the Red List a single product - documentation showing that a minimum of five (5) consecutive, non-violative, commercial shipments have been released based on private laboratory analyses.
b. Requests to remove from the Red List multiple products from a manufacturer - a minimum of twelve (12) non-violative shipments representative of products covered by detention without physical examination.***
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Dr, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov
Requests for removal from detention without physical examination will be forwarded to CVM for evaluation.
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving analysis, preparation, or analytical methodology should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalert@fda.hhs.gov
Questions or issues with regard to center policy on animal food, sample collection recommendations, or any additional questions, should be addressed to CVM/Division of Food Compliance at CVMImportRequests@fda.hhs.gov
*** ***
Product Description:
Animal foods ***(articles used for food or drink for animals other than humans); and (2) articles used for components of any such articles.)***
Charge:
***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)]***
OASIS Charge code - SALMONELLA
[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
Rosedale Meats
Date Published : 08/21/2015
3 Swyer St
, Hampton,
Victoria 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,
Victoria 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
Masterfeeds
Date Published : 11/15/2021
6015 54 Ave
, Taber,
Alberta CANADA
71 K - - 01 Beet Pulp Veg Byprod
Date Published: 11/15/2021
Desc: Beet Pulp
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
71 L - - 07 Soybean Meal
Date Published: 03/08/2023
Desc: Soyplus feed
71 L - - 99 Oilseed Byprod N.E.C.
Date Published: 03/08/2023
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 Seed)
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, Binh Tan District , 555, Kinh Duong Vuong St.
, Ho Chi Minh City,
Ho Chi Minh City VIETNAM
16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 05/06/2020
Desc: Fish Meal
Notes: 5/22/2009
Problems:
SALMONELLA;
71 D - - 03 Fish Meal
Date Published: 05/06/2020
Desc: Fish Meal
Notes: 5/22/2009
Problems:
SALMONELLA;