Select Agents and Toxins Exclusions
Avian influenza virus (low pathogenic)
Any low pathogenic strains of avian influenza virus, avian paramyxovirus serotype-1 (APMV-1) viruses which do not meet the criteria for Newcastle disease virus, including those identified as pigeon paramyxovirus-1 isolated from a non-poultry species, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), provided that the individual or entity can identify that the agent is within the exclusion category.
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) 103KB. Specific reference vaccine strains have not been listed here for proprietary reasons.
Foot-and-mouth disease, FMD-LL3B3D A24 Cruzeiro, vaccine virus (effective April 30, 2018)
The FMD-LL3B3D A24 Cruzeiro vaccine virus is a foot-and-mouth disease (FMD) virus attenuated through the deliberate deletion of a leader sequence of the FMD virus genome. The vaccine virus attenuation prevents replication in target hosts and includes a negative marker in the viral genome to enable differentiation of animals infected versus vaccinated.
- Belsham G. Influence of the Leader protein coding region of foot-and-mouth disease virus on virus replication.J Gen Virol. 2013 Jul; 94(7):1486-95
- Guan S, Belsham G. Separation of foot-and-mouth disease virus leader protein activities; identification of mutants that retain efficient self-processing activity but poorly induce eIF4G cleavage. J Gen Virol. 2017 Apr; 98(4):671-680.
- Uddowla S, Hollister J, Pacheco JM, Rodriquez LL, Rieder E. A safe foot-and-mouth disease vaccine platform with two negative markers for differentiating infected from vaccinated animals. J Virol. 2012 Nov; 86(21):11675-85.
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