NIH GUIDE, Volume 22, Number 8, February 26, 1993

P.T. 34


  Animal Research Policy 

Public Health Service

Introduction:  In 1990, the Assistant Secretary for Health

established the Public Health Service (PHS) Coordinating Committee on

Animal Research to deal more effectively with the threat to

biomedical and behavioral research and testing posed by the animal

activist movement.  The following two statements, released by the

Committee in December, 1992, represent the PHS position on these

important issues:


This statement has been prepared to inform the general public about

the need for animal testing to ensure that medications, vaccines,

environmental chemicals, and a wide variety of consumer products,

including cosmetics, are safe for the public when used appropriately.

The Public Health Service (PHS) is concerned that animal activist

organizations are trying to convince the public incorrectly that

product testing in animals is outdated and no longer necessary.

Consumers may be further confused by announcements that some

companies have stopped testing their products in laboratory animals.

For example, two ways in which a company can make such a claim are by

using only ingredients that historically are known to be safe or that

have been previously tested in animals and found to be non-toxic.

When new ingredients need to meet testing and safety requirements, it

is often necessary to test them in one or more animal species.

To protect the public from unexpected or unintended effects of toxic

substances, some PHS agencies conduct and support toxicological

testing to determine the harmful effects of commonly used products.

To judge whether a product may be unhealthy, or even deadly, for

humans and animals, scientists called toxicologists must know how the

substance is absorbed, distributed, used, stored, and released by the

body.  For some products, it may be necessary to identify long-term,

cumulative health effects, such as the potential to cause cancer,

promote birth defects, affect reproduction, or harm the nervous

system.  Without laboratory animals, scientists would lose a

fundamental method for obtaining the data needed to make wise

decisions about potential health risks.

The PHS agencies support many initiatives to develop and validate

systems to reduce dependency on animal testing.  Scientists have

become skilled in culturing a wide variety of tissue and organ cells

outside the living body (in vitro) and in writing computer programs

that simulate human and animal systems.

Human and animal cell cultures are being used increasingly to screen

toxic substances before progressing to whole-animal testing. When in

vitro studies show that a substance is toxic, testing it in animals

may not be necessary.  Computer models are also being used to help

predict the properties of substances and their probable actions in

living systems.  Although computers can store and analyze enormous

amounts of data, some information must come from experimental

animals.  These non-animal research tools have reduced our dependence

on animals, but they cannot completely replace experimental animals

for the foreseeable future.

Toxicologists have the responsibility to treat laboratory animals

with great care and compassion.  Today, all projects involving animal

testing supported by funds from the PHS must comply with the

regulations of the Animal Welfare Act, as amended, and the Health

Research Extension Act.  These laws were enacted to protect research

animals.  An institution that uses laboratory animals for any purpose

must operate a sound animal care program.  The PHS fosters quality

control in animal care and has a high regard for the welfare of

laboratory animals.

The American people want assurance that the products they use in

recovery from illness and daily living are safe; the U.S. Congress

has enacted laws that require the safety of products; and the

scientific community endeavors to promote the public health through

animal testing.  Dr. James O. Mason, Assistant Secretary for Health,

has put it this way:  "Whole animals are essential in research and

testing because they best reflect the dynamic interactions between

the various cells, tissues, and organs comprising the human body."

The number of products used by society has increased greatly since

animal testing began, but adverse health effects are relatively

uncommon.  This is, in itself, compelling evidence for the predictive

value of animal testing of products for human use.


As a result of a recent lawsuit brought by two animal protectionist

organizations, a Federal court ordered the U.S. Department of

Agriculture (USDA) to reconsider its exclusion of rats, mice, and

birds from coverage under the Animal Welfare Act.  In the judge's

opinion, "the USDA's decision not to regulate these species sent a

message that researchers may subject these animals to cruel and

inhumane conditions."

People who are familiar with the extensive system of U.S. laws,

regulations, guidelines, and principles that protect the welfare of

laboratory animals would not necessarily agree with the judge's

comment.  The Public Health Service (PHS) wants to reassure the

American people that other laws exist to safeguard the welfare of

rats, mice, and birds, species that comprise about 90% of research


According to the Health Research Extension Act, over 1,000

institutions receiving funds from the PHS to conduct animal

experiments are required to comply with the provisions of the Act and

to follow the recommendations in the Guide for the Humane Care and

Use of Laboratory Animals (Guide).  The Guide was prepared to assist

researchers in maintaining high quality care for all commonly-used

laboratory animals.  It includes the Government principles for animal

care and use adopted by all agencies and institutions that conduct

federally-supported animal research.  This guide also applies under

another Federal law, the Good Laboratory Practices Act.  Research

laboratories that conduct studies using rats and mice are regulated

by the PHS's Food and Drug Administration and are subject to


In addition, most institutions that do not receive PHS funding follow

the Guide.  For example, laboratory animal breeders, pharmaceutical

manufacturers, and commercial research laboratories that may not be

subject to USDA and PHS regulations voluntarily participate in a

national program of certification by the American Association for

Accreditation of Laboratory Animal Care.  This private organization

monitors institutional animal care programs to be sure they maintain

the standards set forth in the Guide.

Animal use is an integral component of biomedical and behavioral

research and testing.  The vast majority of scientists recognize that

good science and good animal care go hand-in-hand and would not

tolerate or condone cruelty to, or inhumane treatment of, any

laboratory animal.


Return to 1993 Index

Return to NIH Guide Main Index

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.