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Avian Dis.: Early history of regulatory requirements
for poultry biologics in the United States.
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| Article Type: | Reprint |
| Subject: |
Poultry industry
(Laws, regulations and rules) Vaccination (Laws, regulations and rules) |
| Authors: |
Espeseth, D.A. Lasher, H. |
| Pub Date: | 03/01/2011 |
| Publication: | Name: Journal of Avian Medicine and Surgery Publisher: Association of Avian Veterinarians Audience: Academic Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2011 Association of Avian Veterinarians ISSN: 1082-6742 |
| Issue: | Date: March, 2011 Source Volume: 25 Source Issue: 1 |
| Topic: | Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation |
| Product: | Product Code: 8000146 Vaccination & Immunization NAICS Code: 621999 All Other Miscellaneous Ambulatory Health Care Services SIC Code: 2015 Poultry slaughtering and processing |
| Organization: | Government Agency: United States. Department of Agriculture |
| Geographic: | Geographic Scope: United States Geographic Code: 1USA United States |
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| Accession Number: | 256602983 |
| Full Text: |
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 laryngotraeheitis 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. 2010;54:1136-1143. |
| Gale Copyright: | Copyright 2011 Gale, Cengage Learning. All rights reserved. |