Import Alert 71-02
(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 # 71-02
Published Date: 05/22/2025
Type: DWPE
Import Alert Name:
"DETENTION WITHOUT PHYSICAL EXAMINATION OF ANIMAL ***FOODS AND FOOD*** INGREDIENTS THAT MAY CONTAIN INGREDIENTS OF ANIMAL ORIGIN"
Reason for Alert:
The revision of this Import Alert (IA) dated 04/14/2025 updates the IA name, reason for alert, guidance section including agency contacts, product description and charge code language. Changes to the import alert are bracketed by asterisks (***).
The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulates the importation of animals and animal-origin materials. Bovine spongiform encephalopathy (BSE) is not the only reason USDA APHIS regulates the importation of animals and animal-origin materials into the U.S., although BSE is the focus of this particular import alert. USDA APHIS classifies foreign countries' BSE risk status as negligible, controlled, or undetermined. They maintain a list of countries' BSE status which can be searched through their website, ***https://www.aphis.usda.gov/.*** USDA's BSE restrictions and requirements are codified in 9 CFR part 94 and 9 CFR part 95.
Given their responsibility for regulating the import of animals and animal-origin materials into the U.S., USDA APHIS also shares with FDA some regulatory authority over the importation of certain ***animal food and animal food ingredients. (Animal food is food for animals other than man and includes animal feed and pet food.) In general, almost all imported animal foods and food ingredients that contain animal-origin material should be accompanied by a valid USDA import permit (VS Form 16-6A) and/or government-issued veterinary health certificate (zoosanitary certificate). As per APHIS's BSE comprehensive rule, APHIS restricts or prohibits the importation of certain animal-origin material based on the BSE risk status of the region of origin/export. USDA APHIS regulates the importation of animal foods or food ingredients that contain or consist of rendered meals, digests, and hydrolyzed proteins (e.g. meat and bone meal, other "meals"), regardless of country of export or species of origin. In addition, APHIS regulates the importation of animal food/food ingredients containing certain other animal by-products for BSE risk mitigation. ***
BSE is a bovine form of uniformly fatal neurological diseases known as TSEs (Transmissible Spongiform Encephalopathies) and BSE is spread by feeding infectious material to cattle. At this time, the causative agent is known to be a mis-formed prion which, when consumed by cattle, may lead to development of the disease. There is no test for the presence of the agent in animal-origin materials. BSE is treated as a public health matter because the consumption of contaminated beef has been linked to a human TSE disease known as vCJD (new variant Creutzfeldt-Jakob Disease).
In support of these USDA import prohibitions, and to monitor for compliance with FDA's regulations found in ***21 CFR 589.2000 ("Animal proteins prohibited in ruminant feed") and 589.2001 ("Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy"), the FDA has a sampling program to conduct sampling and analysis of animal food and food*** ingredients offered for entry into the U.S. for the presence of animal-origin material.
The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulates the importation of animals and animal-origin materials. Bovine spongiform encephalopathy (BSE) is not the only reason USDA APHIS regulates the importation of animals and animal-origin materials into the U.S., although BSE is the focus of this particular import alert. USDA APHIS classifies foreign countries' BSE risk status as negligible, controlled, or undetermined. They maintain a list of countries' BSE status which can be searched through their website, ***https://www.aphis.usda.gov/.*** USDA's BSE restrictions and requirements are codified in 9 CFR part 94 and 9 CFR part 95.
Given their responsibility for regulating the import of animals and animal-origin materials into the U.S., USDA APHIS also shares with FDA some regulatory authority over the importation of certain ***animal food and animal food ingredients. (Animal food is food for animals other than man and includes animal feed and pet food.) In general, almost all imported animal foods and food ingredients that contain animal-origin material should be accompanied by a valid USDA import permit (VS Form 16-6A) and/or government-issued veterinary health certificate (zoosanitary certificate). As per APHIS's BSE comprehensive rule, APHIS restricts or prohibits the importation of certain animal-origin material based on the BSE risk status of the region of origin/export. USDA APHIS regulates the importation of animal foods or food ingredients that contain or consist of rendered meals, digests, and hydrolyzed proteins (e.g. meat and bone meal, other "meals"), regardless of country of export or species of origin. In addition, APHIS regulates the importation of animal food/food ingredients containing certain other animal by-products for BSE risk mitigation. ***
BSE is a bovine form of uniformly fatal neurological diseases known as TSEs (Transmissible Spongiform Encephalopathies) and BSE is spread by feeding infectious material to cattle. At this time, the causative agent is known to be a mis-formed prion which, when consumed by cattle, may lead to development of the disease. There is no test for the presence of the agent in animal-origin materials. BSE is treated as a public health matter because the consumption of contaminated beef has been linked to a human TSE disease known as vCJD (new variant Creutzfeldt-Jakob Disease).
In support of these USDA import prohibitions, and to monitor for compliance with FDA's regulations found in ***21 CFR 589.2000 ("Animal proteins prohibited in ruminant feed") and 589.2001 ("Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy"), the FDA has a sampling program to conduct sampling and analysis of animal food and food*** ingredients offered for entry into the U.S. for the presence of animal-origin material.
Guidance:
***Divisions may detain, without physical examination, all food product(s) which appear to be intended for ruminants offered for import from those firms that are identified on the red list of this import alert, as such firms have been found to offer product(s) containing animal-origin material prohibited by 21 CFR 589.2000 and/or 589.2001. (See CFR 589.2000(a)(7) for the definition of “ruminant”). Specific product(s) on the red list are the original violative product(s) offered for import by the firm. Other products offered for import by the firm on the red list, and which appear to be intended for ruminants, may also be subject to DWPE. Entry lines consisting solely of a single, unprocessed whole raw agricultural commodity (e.g., only whole corn, only whole barley, only whole soybeans, etc.) are considered low risk for contamination and may not be subject to DWPE under this import alert unless specified in the red list.***
***Recommendations for addition to the Red List of the alert, require documentation of the Center for Veterinary Medicine (CVM) concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO) for processing.***
***NOTE:
In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the Division Compliance Officer listed on the FDA Notice of Action.***
*** Removal from Detention Without Physical Examination (REMOVAL FROM THE RED LIST):
In order to remove a firm 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 information should help the Agency have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations. For further guidance on removal from DWPE, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)." ***
FDA recommends that firms requesting removal from DWPE provide the following information:
1. Evidence that the firm has determined that the products it is importing are in compliance with ***21 CFR 589.2000 and/or 589.2001, because it has taken appropriate steps to prevent the presence of prohibited animal-origin material in its products. This may *** be documented by:
a. Results of the firm's own investigation(s) into the root cause of the violation that led the firm to be placed on DWPE.
b.*** Documentation to demonstrate that insanitary conditions have been resolved (copies of written procedures, updates of the food safety plan, changes in purchasing specifications, for example). ***
c. Copies of current written procedures that explain the firm's manufacturing process, and which demonstrate an understanding of the requirements of ***21 CFR 589.2000 and/or 589.2001***.
d. Copies of manufacturing records demonstrating that the firm's products are being manufactured according to the process described in the firm's written procedures.
e. Photographs showing the processing equipment, including any new, adjusted, or cleaned equipment, for example.
f. Documentation showing that the facility has been inspected or evaluated by the regulatory authority in the country of origin ***or by a third-party auditor after the violation that led the firm to be placed on DWPE and that there were no findings from the inspection or evaluation or audit*** that would give rise to an appearance that the violation continues.
g.*** Verification that the current processes being used to prevent the presence of prohibited animal-origin materials are adequate, including documentation showing that a minimum of five (5) non-violative product samples (representative of a lot) have been analyzed by a third-party laboratory using feed microscopy, polymerase chain-reaction (PCR), or a combination of both methods, to show the products contained no prohibited animal-origin materials. Products sampled should be processed foods intended for ruminants.***
OR
2. Evidence that the product is the subject of a valid USDA import permit (VS Form 16-6A), if the product contains animal-origin materials.
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 sent via email to:
Importalerts2@fda.hhs.gov
Requests for removal from detention without physical examination will be reviewed by the subject matter experts within the Division of Import Operation (DIO) and referred to CVM for evaluation.
***Questions or issues involving import operations should be addressed to OII/DIO at (301) 796-0356 or Imports@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@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.
***
***Recommendations for addition to the Red List of the alert, require documentation of the Center for Veterinary Medicine (CVM) concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO) for processing.***
***NOTE:
In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the Division Compliance Officer listed on the FDA Notice of Action.***
*** Removal from Detention Without Physical Examination (REMOVAL FROM THE RED LIST):
In order to remove a firm 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 information should help the Agency have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations. For further guidance on removal from DWPE, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)." ***
FDA recommends that firms requesting removal from DWPE provide the following information:
1. Evidence that the firm has determined that the products it is importing are in compliance with ***21 CFR 589.2000 and/or 589.2001, because it has taken appropriate steps to prevent the presence of prohibited animal-origin material in its products. This may *** be documented by:
a. Results of the firm's own investigation(s) into the root cause of the violation that led the firm to be placed on DWPE.
b.*** Documentation to demonstrate that insanitary conditions have been resolved (copies of written procedures, updates of the food safety plan, changes in purchasing specifications, for example). ***
c. Copies of current written procedures that explain the firm's manufacturing process, and which demonstrate an understanding of the requirements of ***21 CFR 589.2000 and/or 589.2001***.
d. Copies of manufacturing records demonstrating that the firm's products are being manufactured according to the process described in the firm's written procedures.
e. Photographs showing the processing equipment, including any new, adjusted, or cleaned equipment, for example.
f. Documentation showing that the facility has been inspected or evaluated by the regulatory authority in the country of origin ***or by a third-party auditor after the violation that led the firm to be placed on DWPE and that there were no findings from the inspection or evaluation or audit*** that would give rise to an appearance that the violation continues.
g.*** Verification that the current processes being used to prevent the presence of prohibited animal-origin materials are adequate, including documentation showing that a minimum of five (5) non-violative product samples (representative of a lot) have been analyzed by a third-party laboratory using feed microscopy, polymerase chain-reaction (PCR), or a combination of both methods, to show the products contained no prohibited animal-origin materials. Products sampled should be processed foods intended for ruminants.***
OR
2. Evidence that the product is the subject of a valid USDA import permit (VS Form 16-6A), if the product contains animal-origin materials.
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 sent via email to:
Importalerts2@fda.hhs.gov
Requests for removal from detention without physical examination will be reviewed by the subject matter experts within the Division of Import Operation (DIO) and referred to CVM for evaluation.
***Questions or issues involving import operations should be addressed to OII/DIO at (301) 796-0356 or Imports@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@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 and food ingredients***
Product Codes for Reference: 69-----, 70A----, 70D--08, 70D--99, 70M--01, 70M--04, 70M--07, 70M--20, 70M--99, 70Y----
Product Codes for Reference: 69-----, 70A----, 70D--08, 70D--99, 70M--01, 70M--04, 70M--07, 70M--20, 70M--99, 70Y----
Charge:
***"The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have
been manufactured, processed, or packed under insanitary conditions."
OASIS charge code: MFR INSAN
AND
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that such article appears to have been
prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
[Adulteration, Section 402(a)(4)]"
OASIS charge code: INSAN BSE***
been manufactured, processed, or packed under insanitary conditions."
OASIS charge code: MFR INSAN
AND
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that such article appears to have been
prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
[Adulteration, Section 402(a)(4)]"
OASIS charge code: INSAN BSE***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CANADA
Sure Crop Feeds
Date Published : 03/30/2016
6863 Hwy 97a North
, Grindrod,
British Columbia CANADA
70 M - - 01 Cattle Mixed Feed Ration
Date Published: 03/30/2016
Desc: CATTLE FEED MIXED RATION-NONMEDICATED