CENTER FOR VETERINARY BIOLOGICS (CVB)
Veterinary biologics are regulated somewhat similar to other (human) biologics through a system of permits and licenses (see Part II). A key aspect of veterinary biologics regulation in terms of their production by modern biotechnology methods involves their division into risk Categories I, II, and III. These are grouped based on biological characteristics and safety concerns.
The first category includes nonviable or killed products, such as inactivated vaccines, bacteria, and viral subunits, which are deemed not to present any new or unusual safety concerns. Examples typically are monoclonal-based products for diagnostic or other uses.
The second category includes products containing live organisms that have been modified by the deletion of one or more genes and/or contain heterologous marker genes. An example that APHIS gives is swine pox virus, gene deleted (TK negative) live virus.
The third category presents the highest level of concern and includes live vectored vaccines, such as products using live vectors to carry R-DNA-derived foreign genes that code for immunizing antigens. More recently, transgenic plant categories have been added. The first Category III product APHIS reviewed was an R-DNA-derived vaccine-vectored rabies glycoprotein vaccine. See Dept. of Agriculture, APHIS, Veterinary Biological Products; Genetically Engineered Live Viral Vectored Vaccine, Notice, 54 Fed. Reg. 161 (1989) (announcing receipt of request to conduct a field trial). Although APHIS concluded the vaccine would not have a significant impact on the environment, the test was still controversial, as has been other testing since product permits and particularly licenses are subject to NEPA requirements. See Dept. of Agriculture, APHIS, Public Meeting; Availability of Environmental Assessment and Preliminary Finding of No Significant Impact for Field Testing of Genetically Engineered Vaccine in Vectored Rabies Vaccine, Notice, 54 Fed. Reg. 9241 (1989) (announcing FONSI).
A summary information format (SIF) outlines important scientific questions and information that should be addressed during the preparation of a veterinary biological product license application. A SIF exists for environmental releases, which refers to the planned introduction of a vaccine microorganism to the environment that can be reached by the microbe or its progeny. Inactivated microorganisms are not considered to pose environmental release risks. See U.S. Dept. of Agriculture, APHIS, Veterinary Services, Center for Veterinary Biologics, Summary Information Format for Environmental Releases, available at www.aphis.usda.gov/vs/cvb/lpd/sifs/vber.html. For a discussion of SIFs, see Veterinary Services Memorandum No. 800.205 (May 28, 2003).
Category I consists of a number of divisions: l-A-1, non-replicating recombinant antigens for therapeutic/prophylactic use; I-A-2, non-replicating recombinant antigens for diagnostic use; I-B-1, monoclonal antibodies for therapeutic/prophylactic use; I-B-2, monoclonal antibodies for diagnostic use; I-C-1, synthetic peptides for therapeutic/prophylactic use; I-C-2, synthetic peptides for diagnostic use; I-D-1, nucleic acid-mediated products for therapeutic/prophylactic use; and I-D-2, nucleic acid-mediated products for diagnostic use.
Category III involves three subsets: III-A, live vectored organisms; III-B-1, transgenic plant-based products for therapeutic/prophylactic use; and III-B-2, transgenic plant-based products for diagnostic use.
A list of licensed products and their types, with product codes, appears at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/CurrentProdCodeBook.pdf.
