By
W. Ron DeHaven, D.V.M.
Deputy Administrator, Animal Care, APHIS-USDA
In May 1997, the Animal Care division of the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service published a booklet of internal policy memoranda. This publication has led to several discussions about the content of these policies and raised questions about their scope and legal authority. This article attempts to clarify these issues and provide specific explanation of policy No.12, “Written Narrative for Alternatives to Painful Procedures.”
To: Introduction | What is Policy? | A Closer Look at Policy No. 12 | Final Thoughts
The U.S. Supreme Court has made clear that the notice and comment procedures associated with typical rulemaking procedures in the Federal Government are essential to establish the legally binding effect of regulations. At the same time, the Court has given broad latitude to agencies of the Executive Branch to interpret their own statutes and regulations.
While such “interpretive rules” do not have the legally binding effect of regulations and are subject to legal challenge, the Courts usually give deference to an agency’s interpretation of its own rules. Accordingly, from a legal perspective, most of the policies contained in the Animal Care Policies booklet are more accurately termed “interpretive rules” since they are statements that clarify or interpret the existing Animal Welfare Act (AWA) regulations. It is only because of convention within our agency that we refer to all such documents generically as “policies.”
Through our policies, we seek to promote uniform application of the regulations based on our knowledge of the intent of the regulations and on the statute on which those regulations are based. While the policies are primarily designed to assist our own Animal Care inspectors, all of you in the regulated community clearly have an inherent interest and stake in our interpretation of the regulations.
To: Introduction | What is Policy? | A Closer Look at Policy No. 12 | Final Thoughts
Before proceeding, I should note that not all of our policies are interpretive rules. Some merely lay out procedures for implementing the existing statutes and regulations. For example, policy No. 17, “Annual Report for Research Facilities,” is a general policy that merely explains the procedures to be followed to generate the annual report to Congress regarding accomplishments under the AWA. The policy does not offer an interpretation of our existing rules.
In contrast, policy No. 12, “Written Narrative for Alternatives to Painful Procedures,” is clearly an interpretive rule that is intended to provide our inspectors–and you–a better understanding of what we believe constitutes adequate documentation of a good faith search for alternatives. This rule is based on the AWA statute that seeks to minimize or avoid discomfort, distress, and pain caused to animals during experimentation.
Policy No. 12 includes the expectation that the principal investigator (PI) will not stop searching simply because he or she is unable to find a nonanimal model. Rather, we would expect the concepts of refinement and reduction to be applied whenever and wherever possible in order to minimize animal pain and distress when it cannot be eliminated. While Congress did not intend to eliminate animals in research, they clearly intended to minimize pain and distress, a fact that is especially evident in the 1985 amendments to the AWA.
The AWA and regulations make the Institutional Animal Care and Use Committee (IACUC) responsible for ensuring that the PI has made a good faith effort in conducting his/her search for alternatives. Accordingly, we place the burden on the IACUC to gather sufficient information to make that determination. As set forth in Policy No. 12, if the PI uses an electronic literature search as the basis for making the required assurance, then the date of the search, the source(s), keywords, and date range will provide the IACUC with the requisite information.
This policy does not, however, rule out other means of conducting a search. We recognize that, in some unique circumstances, there can be a better method of conducting the search and giving the IACUC the assurance it needs. That is why the policy allows the PI to provide an alternate search strategy that describes the “methods and sources used to determine that no alternatives were available to the painful or distressful procedure.”
To: Introduction | What is Policy? | A Closer Look at Policy No. 12 | Final Thoughts
Our intention in developing Policy No. 12–and other policies–is to provide clear and consistent guidelines so that all of our licensees and registrants are held to the same standards. While we try to avoid being too prescriptive, there is also a compelling need for consistent interpretation and enforcement of the regulations.
Nowhere is this more evident than with the issue of documenting searches for alternatives to painful procedures. We believe Policy No. 12 is necessary to ensure uniformity among AC inspectors and provide a clear understanding of our expectations to the biomedical research community. Although it met with negative reaction when it was initially implemented, we are pleased that there now seems to be general support for the content of this policy.
To: Introduction | What is Policy? | A Closer Look at Policy No. 12 | Final Thoughts
Go to:
Contents, Animal Welfare Information Center Bulletin
Top of Document
The Animal Welfare Information Center
U.S. Department of Agriculture
Agricultural Research Service
National Agricultural Library
10301 Baltimore Ave.
Beltsville, MD 20705-2351
Phone: (301) 504-6212
FAX: (301) 504-7125
E-mail: awic@nal.usda.gov
