The Center for Alternatives to Animal Testing is an academic center affiliated with the Division of Toxicological Sciences in the Department of Environmental Health Sciences of the Johns Hopkins University Bloomberg School of Public Health.

 

Johns Hopkins School of Public Health

Proceedings for CAAT 20th Anniversary Symposium

The Animal Welfare Act and the 3 Rs -- Where Are We and Where Should We Go?

Paul A. Locke
Johns Hopkins University

The Animal Welfare Act (AWA or the Act) is the major federal legislation governing the use and treatment of animals in biomedical research. It was originally enacted in 1966, and has been substantially amended several times since its enactment. The most significant amendment affecting biomedical research was passed in 1985.

The 1985 amendments to the AWA added detailed requirements regarding laboratory animals. In particular, these amendments call for prevention of pain and distress and mandate:

The 1985 amendments strive to balance the welfare of animals with the necessity of biomedical research. Although they regulate the treatment, use, transportation and care of animals, they specifically prohibit the regulation of the design, outline or guidelines of actual research or experimentation. As such, it can be argued that they carve out certain decisions about animal research that are beyond the reach of the AWA.

These amendments also call for the formation of animal care and use committees (IACUCs) at institutions covered by the AWA. Among their responsibilities, IACUCs are charged with inspecting all animal study areas and reviewing practices to ensure compliance with provisions of the AWA to minimize pain and distress to animals. The Act specifically states that IACUCs are intended to "represent society's concerns regarding the welfare of animals used ..." (42 USC §2143(b) (1)).

From the perspective of animal welfare advocates and biomedical researchers, IACUCs have become one of the most noticable features of the AWA. They are in a unique position to evaluate research protocols involving animals, suggest ways to minimize pain and distress, and work directly with researchers before experiments have started.

The 3Rs -- reduction, refinement and replacement -- are the principles that underlie humane treatment of animals in biological experimentation. Throughout its first 20 years, CAAT has made the 3Rs one of its guiding themes. As developed and shaped by Russell and Burch in The Principles of Humane Experimental Technique, the 3Rs are in part based on the notion that good science evolves in parallel with, and as a result of, humane science.

This presentation will review the AWA, with a focus on the 1985 amendments. It will examine how the AWA and its implementation have incorporated the 3Rs and suggest ways to continue to advance the adoption of the 3Rs through application of the AWA as well as by other means. Policy aspects of animal welfare in biomedical research are essential to societal concerns for a number of reasons. As attention that is paid to these issues grows, options should be developed that can simultaneously bolster animal welfare and assure that researchers are employing the best science to study disease processes, treatments and toxicological mechanisms.

This presentation will...

If you are a researcher considering an experiment which traditionally involves whole animal procedures, how do you determine whether an alternative procedure exists?

Four Key Questions

  1. Why is the law important?
  2. Why is the AWA important?
  3. What are the 3Rs and what is their relationship to the AWA?
  4. How can we continue to advance the adoption of the 3Rs and humane science?

Why is the law important?

What the law does?

Continuum of How Animals are Viewed in Biomedical Research

Figure 1

Why is the AWA important?

The AWA -- brief overview

42 USC §2143(a)(1) & (6)

The AWA -- 1985 amendments

The AWA -- IACUCs

42 USC §2143(b)(1) & (3)

What are the 3 Rs and what is their relationship to the AWA?

The 3 Rs

Russell & Burch, The Principles of Humane Experimental Technique (1959)

Underlying principle -- good science

"[B]y now it is widely recognized that the humanist possible treatment of experimental animals, far from being an obstacle [to biomedical research], is actually a prerequisite for successful animal experiments."

Russell & Burch, Chapter 1

Reduction Alternatives

Zurlo, Rudacille & Goldberg, The 3Rs: The Way Forward 104 Env't Health. Persp. __ (August, 1966)

Refinement Alternatives

Zurlo, Rudacille & Goldberg, The 3Rs: The Way Forward 104 Env't Health. Persp. __ (August, 1966)

Replacement

Zurlo, Rudacille & Goldberg, The 3Rs: The Way Forward 104 Env't Health. Persp. __ (August, 1966)

The 3Rs and the AWA

"As characterized by Congress, the 1985 amendments reflect[ed] the importance of the 'three Rs': reduction in the number of animals used, refinement of cruel techniques, and replacement of animals with plants and computer simulations."

Mendelson, Should Animals Have Standing? A Review of Standing Under the Animal Welfare Act 24 Environmental Affairs 795, 801 (quoting 137 Cong. Rec. E1295 (1991))

Incorporating the 3Rs into the AWA

How can we continue to advance the adoption of the 3Rs and humane science?

Focus on IACUCs

The AWA mentions only some of the techniques available for implementing 3Rs

Figure 2

Evaluating the Role of IACUCs

Frequency Distribution of Original and Second Protocol Recommendations*

Original recommendation
Second recommendation Approve as written Contingent approval Defer decision disapprove protocol
Approve as written 6 11 2 0
Contingent approval 26 24 1 2
Defer decision 31 27 2 1
Disapprove protocol 9 7 1 0
Total 72 69 6 3
*"Contingent approval" means approval with clarification or minor modification. "Deferred decisions" require further information.

Plous and Herzog, Reliabilty of Protocol Reviews for Animal Research, Science 293:608-9 (27 July 2001)

Agenda for Moving Forward