Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Search research articles

Related Experiment Videos

Current USDA procedures for licensing biotechnology-derived veterinary biologicals.

¹USDA/APHIS/BBEP, Hyattsville, MD 20782.

Developments in Biological Standardization

|January 1, 1992

Summary

This paper reviews U.S. regulations for biotechnology-derived veterinary biologicals, focusing on risk-based policies by the Animal and Plant Health Inspection Service (APHIS) to balance safety and innovation.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Hyperimmune egg yolk antibodies developed against Clostridium perfringens antigens protect against necrotic enteritis.

Poultry science·2023

Same author

Current USDA licensing requirements for recombinant DNA-derived animal biological products.

Revue scientifique et technique (International Office of Epizootics)·2020

Same author

Environmental considerations for field testing and licensing of live genetically-engineered veterinary biologics.

Revue scientifique et technique (International Office of Epizootics)·2020

Same author

Global Foot-and-Mouth Disease Research Update and Gap Analysis: 1 - Overview of Global Status and Research Needs.

Transboundary and emerging diseases·2016

Same author

Global Foot-and-Mouth Disease Research Update and Gap Analysis: 2 - Epidemiology, Wildlife and Economics.

Transboundary and emerging diseases·2016

Same author

Global Foot-and-Mouth Disease Research Update and Gap Analysis: 3 - Vaccines.

Transboundary and emerging diseases·2016

Area of Science:

Veterinary Medicine
Biotechnology Regulation
Agricultural Science

Background:

International debate surrounds regulating biotechnology product commercialization.
The United States Department of Agriculture (USDA) oversees veterinary biologicals.
Ensuring appropriate regulatory frameworks is crucial for scientific advancement.

Purpose of the Study:

To outline current regulatory procedures for biotechnology-derived veterinary biologicals in the U.S.
To detail the role of the Animal and Plant Health Inspection Service (APHIS) and its Biotechnology, Biologics, and Environmental Protection (BBEP) division.
To explain how recent policies aim for risk-based regulation.

Main Methods:

Review of current regulatory procedures within the USDA.
Analysis of policies established by the Biotechnology, Biologics, and Environmental Protection (BBEP).
Examination of risk-based regulatory approaches.

Main Results:

The USDA, through APHIS's BBEP, has established procedures for regulating biotechnology-derived veterinary biologicals.
Recent BBEP policy emphasizes risk-based regulation.
The goal is to avoid overly restrictive measures that could hinder product development.

Conclusions:

Current U.S. regulatory procedures aim to facilitate the safe commercialization of veterinary biotechnological products.
The implemented policies support innovation while ensuring safety.
Risk-based approaches are central to the regulatory strategy.

Related Experiment Videos