Note: The revision of this Import Alert (IA) dated 03/25/2025 updates the IA name, reason for alert, guidance section including agency contacts and PAC. This revision also incorporates firms and products previously covered under Import Alert #72-03 �Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella�, which will be deactivated. 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 ***food other than pet food, e.g. swine feed) can cause illness in animals that consume the food.*** 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 food from foreign manufacturers, collected at entry, have been found to be positive for Salmonella. ***This import alert now covers all animal food, including pet treats, found to contain Salmonella. Pet treats previously covered by Import Alert #72-03, "Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella,� are now listed under the Red List of this import alert and Import Alert #72-03 has been deactivated.***
Animal foods (articles used for food or drink for animals other than humans); and (2) articles used for components of any such articles.)
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
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 ***food for animals*** 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 ***(DCGDE3)***. 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 ***(including treats),*** this may include providing evidence that the pet food does not contain any Salmonella serotypes. ***An example of such evidence may include private laboratory analysis of a representative sample of the shipment.*** 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 ***for a minimum of three production runs of the product.*** 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) ***consecutive*** 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 DWPE 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 forwarded to CVM for evaluation. ***Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov Questions or issues involving analysis, preparation, or analytical methodology should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues with regard to 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 ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 03/25/2025 updates the IA name, reason for alert, guidance section including agency contacts and PAC. This revision also incorporates firms and products previously covered under Import Alert #72-03 �Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella�, which will be deactivated. 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 ***food other than pet food, e.g. swine feed) can cause illness in animals that consume the food.*** 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 food from foreign manufacturers, collected at entry, have been found to be positive for Salmonella. ***This import alert now covers all animal food, including pet treats, found to contain Salmonella. Pet treats previously covered by Import Alert #72-03, "Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella,� are now listed under the Red List of this import alert and Import Alert #72-03 has been deactivated.***
Country-specific information is available in the full alert detail on the FDA website.
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