Select Agents and Toxins Exclusions

Attenuated strains of USDA-only select agents excluded from the requirements of 9 CFR Part 121


AFRICAN SWINE FEVER VIRUS
  • African swine fever virus, ASFV-G-ΔI177L (effective April 3, 2020)
    The ASFV-G-ΔI177L virus strain is an African swine fever virus (AFSV) deletion mutant derived from AFSV Georgia strain. Attenuation is provided by the deliberate deletion of the I177L gene from the ASFV Georgia strain. The deletion mutant virus attenuation prevented the development of clinical signs in host animals inoculated with increasing doses of the attenuated live virus.

    Reference(s):

    1. Arias, M., de la Torre, A., Dixon, L., Gallardo, C., Jori, F., Laddomada, A., Sanchez, V. (2017). Approaches and Perspectives for Development of African Swine Fever Virus Vaccines. Vaccines (Basel), 5(4). doi:10.3390/vaccines5040035
    2. Borca MV, Ramirez-Medina E, Silva E, Vuono E, Rai A, Pruitt S, Holinka LG, Velazquez-Salinas L, Zhu J, Gladue DP.  (2020). Development of a highly effective African swine fever virus vaccine by deletion of the I177L gene results in sterile immunity against the current epidemic Eurasia strain. Virology 2020 Jan 22, pii: JVI.02017-19.  doi: 10.1128/JVI.02017-19.
    3. Galindo, I., & Alonso, C. (2017). African Swine Fever Virus: A Review. Viruses, 9(5). doi:10.3390/v9050103
    4. Gallardo, C., Fernandez-Pinero, J., & Arias, M. (2019). African swine fever (ASF) diagnosis, an essential tool in the epidemiological investigation. Virus Res, 271, 197676. doi:10.1016/j.virusres.2019.197676
    5. Neilan, J. G., Zsak, L., Lu, Z., Burrage, T. G., Kutish, G. F., & Rock, D. L. (2004). Neutralizing antibodies to African swine fever virus proteins p30, p54, and p72 are not sufficient for antibody-mediated protection. Virology, 319(2), 337-342. doi:10.1016/j.virol.2003.11.011
    6. Sánchez-Vizcaino, J. M., Martínez-López, B., Martínez-Avilés, M., Martins, C., Boinas, F., Vial, L., . . .Roger, F. (2009). Scientific report submitted to EFSA on African Swine Fever. (CFP/EFSA/AHAW/2007/2).
    7. World Organisation for Animal Health (OIE). (2019). African swine fever (infection with African swine fever virus) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

  • African swine fever virus, ASFV-G-Δ9GL/ΔUK (effective January 27, 2020)
    The ASFV-G-Δ9GL/ΔUK virus strain is an African swine fever virus (AFSV) double mutant derived from AFSV Georgia strain. Attenuation is provided by the deliberate deletion of both the 9GL and UK genes from the ASFV Georgia strain. The double mutant virus attenuation prevented the development of clinical signs in host animals inoculated with increasing doses of the attenuated live virus.

    Reference(s):

    1. Arias, M., de la Torre, A., Dixon, L., Gallardo, C., Jori, F., Laddomada, A.,  Sanchez, V. (2017). Approaches and Perspectives for Development of African Swine Fever Virus Vaccines. Vaccines (Basel), 5(4). doi:10.3390/vaccines5040035
    2. Galindo, I., & Alonso, C. (2017). African Swine Fever Virus: A Review. Viruses, 9(5). doi:10.3390/v9050103
    3. Gallardo, C., Fernandez-Pinero, J., & Arias, M. (2019). African swine fever (ASF) diagnosis, an essential tool in the epidemiological investigation. Virus Res, 271, 197676. doi:10.1016/j.virusres.2019.197676
    4. Lewis, T., Zsak, L., Burrage, T. G., Lu, Z., Kutish, G. F., Neilan, J. G., & Rock, D. L. (2000). An African swine fever virus ERV1-ALR homologue, 9GL, affects virion maturation and viral growth in macrophages and viral virulence in swine. J Virol, 74(3), 1275-1285. doi:10.1128/jvi.74.3.1275- 1285.2000
    5. Neilan, J. G., Zsak, L., Lu, Z., Burrage, T. G., Kutish, G. F., & Rock, D. L. (2004). Neutralizing antibodies to African swine fever virus proteins p30, p54, and p72 are not sufficient for antibody-mediated protection. Virology, 319(2), 337-342. doi:10.1016/j.virol.2003.11.011
    6. O'Donnell, V., Risatti, G. R., Holinka, L. G., Krug, P. W., Carlson, J., Velazquez-Salinas, L., Borca, M.V. (2017). Simultaneous Deletion of the 9GL and UK Genes from the African Swine Fever Virus Georgia 2007 Isolate Offers Increased Safety and Protection against Homologous Challenge. J Virol, 91(1). doi:10.1128/JVI.01760-16
    7. Sánchez-Vizcaino, J. M., Martínez-López, B., Martínez-Avilés, M., Martins, C., Boinas, F., Vial, L., Roger, F. (2009). Scientific report submitted to EFSA on African Swine Fever. (CFP/EFSA/AHAW/2007/2).
    8. World Organisation for Animal Health (OIE). (2019). African swine fever (infection with African swine fever virus) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
    9. Zsak, L., Caler, E., Lu, Z., Kutish, G. F., Neilan, J. G., & Rock, D. L. (1998). A nonessential African swine fever virus gene UK is a significant virulence determinant in domestic swine. J Virol, 72(2), 1028- 1035.

  • African swine fever virus, ASFV-G-ΔMGF (effective January 27, 2020)
    The ASFV-G-ΔMGF virus strain is an African swine fever virus (AFSV) mutant derived from AFSV Georgia strain. Attenuation is provided by the deliberate deletion of six multigene family 360 (MGF360) and MGF505 group of genes. The deletions contained in the attenuated virus prevented the development of clinical signs in host animals inoculated with increasing doses of the attenuated live virus.

    Reference(s):

    1. Arias, M., de la Torre, A., Dixon, L., Gallardo, C., Jori, F., Laddomada, A.,  Sanchez, V. (2017). Approaches and Perspectives for Development of African Swine Fever Virus Vaccines. Vaccines (Basel), 5(4). doi:10.3390/vaccines5040035
    2. Boinas, F. S., Hutchings, G. H., Dixon, L. K., & Wilkinson, P. J. (2004). Characterization of pathogenic and non-pathogenic African swine fever virus isolates from Ornithodoros erraticus inhabiting pig premises in Portugal. J Gen Virol, 85(Pt 8), 2177-2187. doi:10.1099/vir.0.80058-0
    3. de la Vega, I., Vinuela, E., & Blasco, R. (1990). Genetic variation and multigene families in African swine fever virus. Virology, 179(1), 234-246. doi:10.1016/0042-6822(90)90293-z
    4. Enjuanes, L., Carrascosa, A. L., Moreno, M. A., & Vinuela, E. (1976). Titration of African swine fever (ASF) virus. J Gen Virol, 32(3), 471-477. doi:10.1099/0022-1317-32-3-471
    5. Galindo, I., & Alonso, C. (2017). African Swine Fever Virus: A Review. Viruses, 9(5). doi:10.3390/v9050103
    6. Gallardo, C., Fernandez-Pinero, J., & Arias, M. (2019). African swine fever (ASF) diagnosis, an essential tool in the epidemiological investigation. Virus Res, 271, 197676. doi:10.1016/j.virusres.2019.197676
    7. Krug, P. W., Holinka, L. G., O'Donnell, V., Reese, B., Sanford, B., Fernandez-Sainz, I., Borca, M. V. (2015). The progressive adaptation of a georgian isolate of African swine fever virus to vero cells leads to a gradual attenuation of virulence in swine corresponding to major modifications of the viral genome. J Virol, 89(4), 2324-2332. doi:10.1128/JVI.03250-14
    8. Martins, C. L., Lawman, M. J., Scholl, T., Mebus, C. A., & Lunney, J. K. (1993). African swine fever virus specific porcine cytotoxic T cell activity. Arch Virol, 129(1-4), 211-225. doi:10.1007/bf01316896
    9. O'Donnell, V., Holinka, L. G., Gladue, D. P., Sanford, B., Krug, P. W., Lu, X.,  Borca, M. V. (2015).African Swine Fever Virus Georgia Isolate Harboring Deletions of MGF360 and MGF505 Genes Is Attenuated in Swine and Confers Protection against Challenge with Virulent Parental Virus. J Virol, 89(11), 6048-6056. doi:10.1128/JVI.00554-15
    10. Pires, S., Ribeiro, G., & Costa, J. V. (1997). Sequence and organization of the left multigene family 110 region of the Vero-adapted L60V strain of African swine fever virus. Virus Genes, 15(3), 271-274. doi:10.1023/a:1007992806818
    11. Ruiz Gonzalvo, F., Caballero, C., Martinez, J., & Carnero, M. E. (1986). Neutralization of African swine fever virus by sera from African swine fever-resistant pigs. Am J Vet Res, 47(8), 1858-1862.
    12. Sánchez-Vizcaino, J. M., Martínez-López, B., Martínez-Avilés, M., Martins, C., Boinas, F., Vial, L., Roger, F. (2009). Scientific report submitted to EFSA on African Swine Fever. (CFP/EFSA/AHAW/2007/2).
    13. World Organisation for Animal Health (OIE). (2019). African swine fever (infection with African swine fever virus) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
    14. Yanez, R. J., Rodriguez, J. M., Nogal, M. L., Yuste, L., Enriquez, C., Rodriguez, J. F., & Vinuela, E. (1995). Analysis of the complete nucleotide sequence of African swine fever virus. Virology, 208(1), 249-278. doi:10.1006/viro.1995.1149


AVIAN INFLUENZA VIRUS (Low Pathogenic)
  • Avian influenza virus (low pathogenic)
    Any low pathogenic strains of avian influenza virus, provided that the individual or entity can identify the agent is within the exclusion category. The Guidelines for Avian Influenza Viruses, located at: https://www.selectagents.gov/guidance-avian.html specify exclusion criteria.


AVIAN INFLUENZA VIRUS (Highly Pathogenic)
  • Avian influenza virus (highly pathogenic), recombinant vaccine reference strains of the H5N1 and H5N3 subtypes (effective 5-7-2004)
    Several recombinant reference vaccine strains of highly pathogenic subtypes have been excluded based on results from in-vitro and in-vivo studies indicating that these strains were not pathogenic in avian species. The data requirements necessary for exclusion consideration under 9 CFR 121.3(g)PDF version 103KB. Specific reference vaccine strains have not been listed here for proprietary reasons.


FOOT-AND-MOUTH DISEASE VIRUS

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