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Veterinary Biologics: History and

Summary of Activities

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Federal regulation of veterinary biologics began in 1913 with passage of the VirusSerum-Toxin Act. This law was enacted largely because of public concern over the

importation of contaminated veterinary vaccines from Europe and in reaction to

complaints about worthless and contaminated hog cholera products being sold

throughout the country. The new law required the Department of Agriculture (USDA)

to ensure that veterinary biologics (vaccines, bacterins, antiserums and similar

products) sold in interstate commerce are pure, safe, potent, and efficacious. In

1985, the Virus-Serum-Toxin Act was amended to include biologics sold in intrastate.

For nearly 50 years, the biologics program was carried out by USDA veterinary field

inspectors located in the commercial biologics manufacturing establishments and by

licensing staff in Washington, DC. In 1961, the biologics program was allocated ten

percent of the space at the National Animal Disease Laboratory (now Center) that

had just been established in Ames, Iowa. The regulatory emphasis shifted from plant

inspection to product testing by the USDA at a central location. For several years in

the 1960s, this was the sole method of product monitoring. The current monitoring

program combines both testing by the USDA as well as plant inspection, although

due to the size and complexity of today's biologics industry, inspection is

coordinated from a centralized office.
The biologics laboratory functions were moved to the facility at 1800 Dayton Avenue

in 1978. The biologics field office (now known as the Inspection and Compliance

unit) was located in various office spaces within Ames, Iowa. Until 1997, the

licensing staff was located in Washington D.C. and various suburbs (Hyattsville and

Riverdale, Maryland).

The veterinary biologics program was originally part of the USDA's Bureau of Animal

Industry. In 1953, it became part of the Animal Health Division of the Agricultural

Research Service. When the USDA formed the Animal and Plant Inspection Service

(APHIS) in 1972, the biologics program was moved to the Veterinary Services (VS)

unit of APHIS. From 1988-1996, the licensing staff and the field office were

organizationally part of the Biologics, Biotechnology, and Environmental Protection

staff of APHIS. The biologics laboratory remained within VS.

In 1996, the units of the veterinary biologics program were reunited under VS and

formed the Center for Veterinary Biologics. Organizationally, the Center was

comprised of three units: Licensing and Policy Development, Inspection and

Compliance, and the Laboratory. In 1997, the licensing staff moved to Ames locating

at 510 South 17th Street, along with the Inspection and Compliance unit. An

Operational Support section remains in Riverdale, Maryland.

In 2003, the Center underwent an organizational realignment to its current two-unit

structure. Review and testing functions were consolidated into the Policy, Evaluation

and Licensing unit. The Inspection and Compliance unit was expanded to include

information management and quality assurance functions for the Center.

Construction was completed in April 2009 on a major modernization effort of the

Ames facilities. In July 2009, the Center colocated with the National Veterinary

Services Laboratories and the National Animal Disease Center as part of the newly

formed National Centers for Animal Health.