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USDA: progress toward in vitro tests and other trends

¹USDA, APHIS, BBEP Veterinary Biologics, Hyattsville, MD, USA.

Developments in Biological Standardization

|January 1, 1996

Summary

The Animal and Plant Health Inspection Service (APHIS) is reducing animal testing for biological products. They are replacing animal tests with in vitro methods and using serological tests, thereby decreasing animal use and suffering.

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Area of Science:

Veterinary Medicine
Toxicology
Animal Welfare Science

Background:

The Animal and Plant Health Inspection Service (APHIS) is committed to the replacement, reduction, and refinement (3Rs) of animal use in biological product testing.
Regulatory agencies face increasing pressure to minimize animal use while ensuring product safety and efficacy.

Purpose of the Study:

To describe specific approaches employed by APHIS to reduce animal use in the development and control of biological products.
To outline APHIS' strategies for minimizing animal pain and suffering.
To discuss the integration of these approaches within APHIS' regulatory framework.

Main Methods:

Replacement of host or laboratory animal potency tests with validated in vitro tests.
Reduction in animal numbers through sequential use for immunologically distinct entities.
Replacement of animal challenge studies with serological tests.
Refinement of extraneous agent testing through validated in vitro methods.

Main Results:

APHIS has successfully reduced animal use by implementing in vitro potency tests and serological assays.
Sequential use of animals has decreased the overall number of animals required for certain tests.
Refinements in extraneous agent testing have enhanced sensitivity and reduced reliance on animal models.

Conclusions:

APHIS has made significant progress in reducing and refining animal use in biological product testing.
The implemented strategies align with ethical considerations and regulatory requirements.
Continued development and validation of alternative methods are crucial for advancing the 3Rs in regulatory science.

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