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History of Regulatory Requirements for Poultry Biologics in the United States, 1970s to 1990s

Espeseth, David A., Lasher, Hiram
Avian diseases 2013 v.57 no.2 pp. 167-171
recombinant DNA, equipment, field experimentation, vaccination, Marek disease, packaging, fowl cholera, compliance, risk assessment, safety standards, poultry products, flocks, infectious bronchitis, environmental assessment, USDA, poultry, vaccines, National Environmental Policy Act, emerging diseases, manufacturing, avian influenza, Anatid alphaherpesvirus 1, poultry industry, United States
By the end of the 1960s, The United States Department of Agriculture (USDA) had established the basic purity and safety standards for poultry biologics in the United States and had licensed products to address many of the major poultry diseases of concern at that time. The emergence of new diseases, advances in scientific technology, and changes in poultry husbandry practices that occurred in the 1970s to the 1990s required the development of many new and amended regulatory requirements to keep abreast of the changing needs of the poultry industry. Veterinary Services often approved the use of special or conditional licensing procedures to shorten the time to license products needed to address emerging diseases. Infectious bronchitis, bursal disease, fowl cholera, duck virus enteritis, avian influenza, and other vaccines were rapidly licensed to address emerging disease problems using this procedure. Changes in labeling and packaging requirements were made to address changing vaccination practices. Veterinary Services permitted diluents to be shipped separate from product, first for Marek's disease vaccine and later for vaccines recommended for administration by automatic vaccinating machines. The maximum number of doses permitted to be in one container and package were also amended to address the increased size of poultry flocks. Veterinary Services also approved the use of split manufacturing procedures that permitted two or more licensed manufacturers to work together in the production of a product. This innovative use of licensing products for further manufacture allowed the industry to use production facilities more efficiently and provided a wider variety of combination products. In 1985, Congress passed an amendment to the Virus-Serum-Toxin Act that gave USDA the authority to regulate all veterinary biological products shipped in or from the United States. This amendment brought intrastate biologics manufacturers under federal jurisdiction and ensured all biological products shipped in or from the United States met the same standards of purity, safety, potency, and efficacy. The development of new recombinant DNA (r-DNA) techniques for the production of vaccines required USDA to establish new procedures and rules for the review of these products prior to their release into the environment and eventual licensure. Compliance with the National Environmental Policy Act required the preparation of environmental risk assessments and public participation in the field testing and licensing of live r-DNA products. This article addresses some of the history of these and other changes in regulatory requirements for poultry products that took place in the 1970s to the 1990s, but space does not permit us to address all of the changes that have occurred. We have presented some of what we consider the most notable events in this process and leave it up to future historians to address events that may not have been included.