title: Early history of regulatory requirements for poultry biologics in the United States.
abstract: Congress passed the Virus-Serum-Toxin Act in 1913, giving the U.S. Department of Agriculture (USDA) authority to prevent the importation or interstate shipment of worthless, contaminated, dangerous, or harmful veterinary biological products. The passage of this act marked the beginning of regulatory requirements for veterinary biological products in the United States. In 1913, only a few biologics establishments produced products for the poultry industry. The first license issued by the USDA for a poultry product was in 1918 to the University of California, Berkeley, for fowlpox vaccine. The list of biological products for poultry grew slowly in the 1920s. However, this began to change with the licensing of laryngotracheitis vaccine in 1933; pigeonpox vaccine in 1939; several Newcastle disease vaccines (inactivated in 1946, Roakin strain in 1948, B1 strain in 1950, and La Sota strain in 1952); and the first bronchitis vaccine in 1953. With the development of these and other new products, the biologics industry began to move its emphasis on hog cholera serum and virus to one based on the production of numerous new vaccines and bacterial products. The USDA's approach to the regulation of biologics in the early 1950s was still geared to the production of hog cholera products; however, as a result of the intervention of a group of dedicated poultry scientists, who were concerned about the poor performance of Newcastle disease vaccines, this soon changed. This presentation describes the initiation and development of modern standards for poultry biologics that occurred as a result of this intervention. The development and improvement of standards and regulatory requirements to address mycoplasma, leukosis, and other extraneous virus contaminations in chicken embryo origin products are reviewed. The licensing of products to meet new and emerging disease problems in the poultry industry and the close interaction among research scientists, poultry industry, biologics manufacturers, and government regulatory officials that has been needed to ensure the availability of products that meet appropriate standards of purity, safety, potency, and efficacy are also addressed.
authors.affiliation: Espeseth Consulting, 404 Longleaf Drive, Perkasie, PA 18944, USA. daespeseth1@verizon.net
authors.forename: David A
authors.initials: DA
authors.lastname: Espeseth
authors.forename: Hiram
authors.initials: H
authors.lastname: Lasher
mesh_terms: D000818:Animals; D001688:Biological Products / Q000266:history* / Q000592:standards* / Q000627:therapeutic use; D004335:Drug and Narcotic Control / Q000266:history*; D049673:History, 20th Century; D011200:Poultry; D011201:Poultry Diseases / Q000188:drug therapy*; D014481:United States
chemical_list: D001688:Biological Products