Cat and Dog Food Manufacturers Required to Consider H5N1 in Food Safety Plans
January 17, 2025
The U.S. Food and Drug Administration has determined that it is necessary for manufacturers of cat and dog foods who are covered by the FDA Food Safety Modernization Act Preventive Controls for Animal Food (PCAF) rule and using uncooked or unpasteurized materials derived from poultry or cattle (e.g., uncooked meat, unpasteurized milk or unpasteurized eggs) to reanalyze their food safety plans to include Highly Pathogenic Avian Influenza virus (specifically H5N1) as a known or reasonably foreseeable hazard. Furthermore, the FDA is issuing this update to ensure that cat and dog food manufacturers are aware of information about the new H5N1 hazard associated with their pet food products, which is an additional reason that manufacturers must conduct a reanalysis of their food safety plans.
The FDA is tracking cases of H5N1 in domestic and wild cats in California, Colorado, Oregon and Washington State that are associated with eating contaminated food products. Scientific information is evolving, but at this time it is known that H5N1 can be transmitted to cats and dogs when they eat products from infected poultry or cattle (e.g., unpasteurized milk, uncooked meat, or unpasteurized eggs) that have not undergone a processing step that is capable of inactivating the virus, such as pasteurizing, cooking or canning. Cats (domestic and large felids) in particular can experience severe illness or death from infection with H5N1. Dogs can also contract H5N1, although they usually exhibit mild clinical signs and low mortality compared to cats. At present, H5N1 has not been detected in dogs in the United States, but there have been fatal cases in other countries.
The FDA Food Safety Modernization Act Preventive Controls for Animal Food (PCAF) rule requires that certain animal food businesses develop a food safety plan. In this food safety plan, animal food businesses must identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Businesses must identify these hazards based on experience, illness data, scientific reports, and other information. In the hazard evaluation, animal food businesses must assess the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls. The animal food industry can find guidance related to these requirements in the FDA’s Center for Veterinary Medicine’s Guidance for Industry #245, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.”
Under the PCAF requirements, animal food businesses must conduct a reanalysis of their food safety plan when the FDA determines it is necessary to respond to new hazards and developments in scientific understanding. The FDA has determined that it is necessary for cat and dog food manufacturers covered by the PCAF rule, who are using uncooked or unpasteurized materials derived from poultry or cattle (e.g., uncooked meat, unpasteurized milk, unpasteurized eggs) in cat or dog food, to reanalyze their food safety plans to include H5N1 as a new known or reasonably foreseeable hazard.
The reanalysis is necessary to respond to the recent domestic cat illnesses and deaths described above and to scientific data indicating that cats and dogs have become ill from consuming H5N1 virus. Manufacturers that implement a preventive control for the H5N1 hazard as a result of their reanalysis will be taking an important step toward protecting cat and dog health and helping to prevent spread of H5N1. Addressing H5N1 will require a concerted effort across sectors, including by government, businesses, and consumers.
Manufacturers also are required to conduct a reanalysis of their food safety plans when they become aware of new information about potential hazards associated with animal food. The FDA and the American Veterinary Medical Association have previously published information on risks to pets from H5N1, which has been amplified in mainstream media. Some additional published references are listed below.
As we learn more about the transmission of H5N1 in animal food, there are several practices that the FDA is encouraging pet food manufacturers and others in the supply chain to use to significantly minimize or prevent H5N1 transmission through animal food. These practices include seeking ingredients from flocks or herds that are healthy, and taking processing steps, such as heat treatment, that are capable of inactivating viruses. For example, some businesses already implement a heat treatment step that is capable of inactivating the virus as a process control. Heat treatments have been shown to be effective for inactivating H5N1 in meat, milk, and egg products. A different practice would be to implement a supply-chain-applied control to provide assurance that ingredients used in animal food do not come from H5N1-infected animals.
To assist animal food businesses as they conduct their reanalysis, we have included a summary of current scientific literature regarding (1) the prevalence of H5N1 in cattle and poultry and their animal-derived ingredients, (2) the severity of H5N1 illness or injury in cats and dogs, and (3) the impact of processing steps on inactivating H5N1.
The FDA and the United States Department of Agriculture (USDA) remain confident in the safety of the food supply. USDA’s Food Safety and Inspection Service, Animal and Plant Health Inspection Service, and Agricultural Research Service (ARS) have completed multiple studies to confirm that meat, poultry and eggs that are properly prepared and cooked are safe to eat. Additionally, to verify the safety of the meat these agencies have completed three separate beef safety studies related to avian influenza in meat from dairy cattle. Furthermore, USDA and the U.S. Food and Drug Administration (FDA) have performed multiple retail sampling studies to reaffirm the safety of the pasteurized milk supply and milk products.
Prevalence of H5N1 in Cattle/Poultry and Animal-Derived Ingredients
Burrough, E. R., Magstadt, D. R., Petersen, B., Timmermans, S. J., Gauger, P. C., Zhang, J., Siepker, C., Mainenti, M., Li, G., Thompson, A. C., Gorden, P. J., Plummer, P. J., & Main, R. (2024). Highly Pathogenic Avian Influenza A(H5N1) Clade 2.3.4.4b Virus Infection in Domestic Dairy Cattle and Cats, United States, 2024. Emerging Infectious Diseases, 30(7). https://doi.org/10.3201/eid3007.240508
Singh, G., Trujillo, J. D., McDowell, C. D., Matias-Ferreyra, F., Kafle, S., Kwon, T., Gaudreault, N. N., Fitz, I., Noll, L., Retallick, J., & Richt, J. A. (2024). Detection and characterization of H5N1 HPAIV in environmental samples from a dairy farm. https://doi.org/10.21203/rs.3.rs-4422494/v1
CDC 2024, Center for Disease Control, CDC Reports Fourth Human Case of H5 Bird Flu Tied to Dairy Cow Outbreak, CDC Reports Fourth Human Case of H5 Bird Flu Tied to Dairy Cow Outbreak, Accessed December 4, 2024. https://www.cdc.gov/bird-flu/situation-summary/index.html
Sreenivasan, Thomas, Kaushik, Wang, & Li. (2019). Influenza A in Bovine Species: A Narrative Literature Review. Viruses, 11(6), 561. https://doi.org/10.3390/v11060561
USDA 2024, United States Department of Agriculture, Animal and Plant Health Inspection Service, HPAI Confirmed Cases in Livestock, Accessed December 4, 2024, https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/hpai-confirmed-cases-livestock
H5N1 Susceptibility and Severity in Companion Animals
Burrough, E. R., Magstadt, D. R., Petersen, B., Timmermans, S. J., Gauger, P. C., Zhang, J., Siepker, C., Mainenti, M., Li, G., Thompson, A. C., Gorden, P. J., Plummer, P. J., & Main, R. (2024). Highly Pathogenic Avian Influenza A(H5N1) Clade 2.3.4.4b Virus Infection in Domestic Dairy Cattle and Cats, United States, 2024. Emerging Infectious Diseases, 30(7). https://doi.org/10.3201/eid3007.240508
Chen, Y., Zhong, G., Wang, G., Deng, G., Li, Y., Shi, J., Zhang, Z., Guan, Y., Jiang, Y., Bu, Z., Kawaoka, Y., & Chen, H. (2010). Dogs are highly susceptible to H5N1 avian influenza virus. Virology, 405(1), 15–19. https://doi.org/10.1016/j.virol.2010.05.024
Frymus, T., Belák, S., Egberink, H., Hofmann-Lehmann, R., Marsilio, F., Addie, D. D., Boucraut-Baralon, C., Hartmann, K., Lloret, A., Lutz, H., Pennisi, M. G., Thiry, E., Truyen, U., Tasker, S., Möstl, K., & Hosie, M. J. (2021). Influenza Virus Infections in Cats. Viruses, 13(8), 1435. https://doi.org/10.3390/v13081435
Giese, M., Harder, T. C., Teifke, J. P., Klopfleisch, R., Breithaupt, A., Mettenleiter, T. C., & Vahlenkamp, T. W. (2008). Experimental Infection and Natural Contact Exposure of Dogs with Avian Influenza Virus (H5N1). Emerging Infectious Diseases, 14(2), 308–310. https://doi.org/10.3201/eid1402.070864
Kim, H. M., Park, E. H., Yum, J., Kim, H. S., & Seo, S. H. (2015). Greater virulence of highly pathogenic H5N1 influenza virus in cats than in dogs. Archives of Virology, 160(1), 305–313. https://doi.org/10.1007/s00705-014-2284-z
Ly, H. (2024). Highly pathogenic avian influenza H5N1 virus infection of companion animals. Virulence, 15(1), 2289780. https://doi.org/10.1080/21505594.2023.2289780
Lyoo, K. S., Na, W., Phan, L. V., Yoon, S. W., Yeom, M., Song, D., & Jeong, D. G. (2017). Experimental infection of clade 1.1.2 (H5N1), clade 2.3.2.1c (H5N1) and clade 2.3.4.4 (H5N6) highly pathogenic avian influenza viruses in dogs. Transboundary and Emerging Diseases, 64(6), 1669–1675. https://doi.org/10.1111/tbed.12731
Maas, R., Tacken, M., Ruuls, L., Koch, G., Van Rooij, E., & Stockhofe-Zurwieden, N. (2007). Avian Influenza (H5N1) Susceptibility and Receptors in Dogs. Emerging Infectious Diseases, 13(8), 1219–1221. https://doi.org/10.3201/eid1308.070393
Ning, Z.-Y., Wu, X.-T., Cheng, Y.-F., Qi, W.-B., An, Y.-F., Wang, H., Zhang, G.-H., & Li, S.-J. (2012). Tissue distribution of sialic acid-linked influenza virus receptors in beagle dogs. Journal of Veterinary Science, 13(3), 219. https://doi.org/10.4142/jvs.2012.13.3.219
Palombieri, A., Di Profio, F., Fruci, P., Sarchese, V., Martella, V., Marsilio, F., & Di Martino, B. (2022). Emerging Respiratory Viruses of Cats. Viruses, 14(4), 663. https://doi.org/10.3390/v14040663
Rabalski, L., Milewska, A., Pohlmann, A., Gackowska, K., Lepionka, T., Szczepaniak, K., Swiatalska, A., Sieminska, I., Arent, Z., Beer, M., Koopmans, M., Grzybek, M., & Pyrc, K. (2023). Emergence and potential transmission route of avian influenza A (H5N1) virus in domestic cats in Poland, June 2023. Eurosurveillance, 28(31). https://doi.org/10.2807/1560-7917.ES.2023.28.31.2300390
Sillman, S. J., Drozd, M., Loy, D., & Harris, S. P. (2023). Naturally occurring highly pathogenic avian influenza virus H5N1 clade 2.3.4.4b infection in three domestic cats in North America during 2023. Journal of Comparative Pathology, 205, 17–23. https://doi.org/10.1016/j.jcpa.2023.07.001
Songserm, T., Amonsin, A., Jam-on, R., Sae-Heng, N., Pariyothorn, N., Payungporn, S., Theamboonlers, A., Chutinimitkul, S., Thanawongnuwech, R., & Poovorawan, Y. (2006). Fatal Avian Influenza A H5N1 in a Dog. Emerging Infectious Diseases, 12(11), 1744–1747. https://doi.org/10.3201/eid1211.060542
Vahlenkamp, T. W., Teifke, J. P., Harder, T. C., Beer, M., & Mettenleiter, T. C. (2010). Systemic influenza virus H5N1 infection in cats after gastrointestinal exposure. Influenza and Other Respiratory Viruses, 4(6), 379–386. https://doi.org/10.1111/j.1750-2659.2010.00173.x
Inactivation of H5N1 by Processing Steps
Cui, P., Zhuang, Y., Zhang, Y., Chen, L., Chen, P., Li, J., Feng, L., Chen, Q., Meng, F., Yang, H., Jiang, Y., Deng, G., Shi, J., Chen, H., & Kong, H. (2024). Does pasteurization inactivate bird flu virus in milk?: Pasteurization inactivates influenza A viruses in milk. Emerging Microbes & Infections, 2364732. https://doi.org/10.1080/22221751.2024.2364732
FDA, 2024: Food and Drug Administration, FDA Website, Updates on Highly Pathogenic Avian Influenza (HPAI) | FDA, June 12 letter, Accessed on June 13, 2024, Updates on Highly Pathogenic Avian Influenza (HPAI) | FDA
Guan, L., Eisfeld, A. J., Pattinson, D., Gu, C., Biswas, A., Maemura, T., Trifkovic, S., Babujee, L., Presler, R., Dahn, R., Halfmann, P. J., Barnhardt, T., Neumann, G., Thompson, A., Swinford, A. K., Dimitrov, K. M., Poulsen, K., & Kawaoka, Y. (2024). Cow’s Milk Containing Avian Influenza A(H5N1) Virus—Heat Inactivation and Infectivity in Mice. New England Journal of Medicine, NEJMc2405495. https://doi.org/10.1056/NEJMc2405495
Spackman, E., Anderson, N., Walker, S., Suarez, D. L., Jones, D. R., McCoig, A., Colonius, T., Roddy, T., & Chaplinski, N. J. (2024). Inactivation of Highly Pathogenic Avian Influenza Virus with High-temperature Short Time Continuous Flow Pasteurization and Virus Detection in Bulk Milk Tanks. Journal of Food Protection, 87(10), 100349. https://doi.org/10.1016/j.jfp.2024.100349
Eggs
Chmielewski, R. A., Beck, J. R., & Swayne, D. E. (2013). Evaluation of the U.S. Department of Agriculture’s Egg Pasteurization Processes on the Inactivation of High-Pathogenicity Avian Influenza Virus and Velogenic Newcastle Disease Virus in Processed Egg Products. Journal of Food Protection, 76(4), 640–645. https://doi.org/10.4315/0362-028X.JFP-12-369
Green, A. L., Branan, M., Fields, V. L., Patyk, K., Kolar, S. K., Beam, A., Marshall, K., McGuigan, R., Vuolo, M., Freifeld, A., Torchetti, M. K., Lantz, K., & Delgado, A. H. (2023). Investigation of risk factors for introduction of highly pathogenic avian influenza H5N1 virus onto table egg farms in the United States, 2022: A case–control study. Frontiers in Veterinary Science, 10, 1229008. https://doi.org/10.3389/fvets.2023.1229008
Kintz, E., Trzaska, W. J., Pegg, E., Perry, W., Tucker, A. W., Kyriakides, A., Antic, D., Callaghan, K., & Wilson, A. J. (2024). The risk of acquiring avian influenza from commercial poultry products and hen eggs: A qualitative assessment. Microbial Risk Analysis, 27–28, 100317. https://doi.org/10.1016/j.mran.2024.100317
Weaver, J. T., Malladi, S., Spackman, E., & Swayne, D. E. (2015). Risk Reduction Modeling of High Pathogenicity Avian Influenza Virus Titers in Nonpasteurized Liquid Egg Obtained from Infected but Undetected Chicken Flocks. Risk Analysis, 35(11), 2057–2068. https://doi.org/10.1111/risa.12374
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.