# Presentation: 099259

## California Department of

**California Department of**
**Fish and Game**

## COMPLIANCE WITH DEA, FDA, AND THE ANIMAL WELFARE ACT: 

**U.S. Department of the Interior**
**U.S. Geological Survey**

**COMPLIANCE WITH DEA, FDA, AND THE ANIMAL WELFARE ACT: **
**A CHALLENGE FOR NATURAL RESOURCE AGENCY VETERINARIANS**

**California Department of**
**Fish and Game**

**Daniel M. Mulcahy, Ph.D., D.V.M.**
**Diplomat  A.C.Z.M.**

**David A. Jessup, D.V.M., M.P.V.M.**
** ****Diplomat  A.C.Z.M.**

**Notes:**
TITLE  SLIDE

Dave:

I couldn’t find a downloadable Ca Fish and Game logo (CDFG webpages show it only as a “watermark”).  So I used the OSPR logo.  Let me know if you want any changes here.  USGS requires the large logo in the upper left hand corner on the title page, and the smaller logo in the lower left hand corner for the rest of the slides.  If you want anything different on the right side of the page--title or following slides--let me know

## ADDITIONAL INFORMATION:

**California Department of**
**Fish and Game**

**ADDITIONAL INFORMATION:**

**www.absc.usgs.gov/research/vet**

**Notes:**
Further information, regulations,  policies, and links for more information can be found at the following web site.  

Dave:

I thought this slide should be shown near the beginning and and again at  the end.

## AUTHORITIES

- Controlled Substances Act of 1970 (21 U.S.C. 802,871b, 951, 958f) (21 CFR, Part 1300 to end).
- Animal Welfare Act of 1970 (P.L. 91-579), modified in 1976 by Amendments to the Animal Welfare Act (P.L. 94-279) (9 CFR, Chapter I).
- Animal Medicinal Drug Use Clarification Act of 1994 (P.L.103-396) (21 CFR Part 530 to end).
- Valid veterinarian/client/patient relationship.

**California Department of**
**Fish and Game**

**AUTHORITIES**

**Notes:**
There are two laws and covering regulations which control the use of controlled substances and  prescription drugs on wildlife and one law dealing with the use of animals in research and management.  It is not the intent of this presentation to discuss the details of the requirements of these laws and regulations.  That information is available from other sources (see web page; Mark Drew’s presentation on AMDUCA in another session.  Rather, we will focus on the implementation of these laws as they specifically pertain to wildlife, and make recommendations for the implementation of agency policies for compliance.  We make no claim for perfection in our approach, rather, we wish to stimulate consideration of developing common approaches to dealing with problems experienced by many agency veterinarians.
Fortunately or unfortunately, wildlife are of peripheral interest to each of these agencies or laws, and the responsibilities of the wildlife veterinarian are often unclear. In general, the agencies enforcing these laws are not extremely helpful or responsive to wildlife veterinarians asking for advice on how to comply with the law. Thus, these laws are a two-edged sword they help justify the employment of wildlife veterinarians, but they leave the veterinarian without clear procedures to follow or direction as to how to help their agency comply with the law.

## Interactions

**California Department of**
**Fish and Game**

**Notes:**
The three controlling laws and their enactment regulations
AMDUCA rules finalized last year.  Previously, much of the "extra-label" use of drugs was essentially illegal, but was looked on by regulators as an act of good faith by veterinarians.  AMDUCA rules formalized the extra-label use of drugs and legalized such use by veterinarians.  However, those same rules have placed the burden for legal use of drugs on the shoulders of veterinarians.  AMDUCA requires that a veterinarian provide for proper drug choice, prescription and dispensing drugs, and acquisition of drugs for extra-label use. 
Few wildlife or fishery biologists are aware of AMDUCA. Some of them are finding out about it as they attempt to purchase drugs which they they may have used for years, only to be asked for a prescription for the drug from a veterinarian.  The inevitable result of this experience will be resentment.  Further, Congress clearly intended to place extra-label drug use under the direct control of veterinarians.   The responsibility for improper use of drugs is placed squarely on the veterinarian who issued the drugs or wrote the prescription, irregardless of who used the drugs. 

## Interactions

**California Department of**
**Fish and Game**

-     Controlled Substances Act with AMDUCA:
-   Few controlled substances used for wildlife immobilization are registered ("Labeled"), making such use "Extra-Label".
-   Use of a registered controlled substance in a new species is "Extra-Label" usage.
-   Use of a narcotic as an analgesic in wildlife is "Extra-Label" if no registration for that use and for that species exists.
-   Record-keeping requirements for both Acts must be satisfied.

## Interactions

**California Department of**
**Fish and Game**

- The Animal Welfare Act with the Controlled Substances Act:
-   Selection of any controlled substance for application to wildlife is subject to review by the IACUC.
-   The entire capture sequence (in which controlled substances are used) is subject to review by the IACUC.
-   The IACUC cannot require or permit the use of a controlled substance for which the veterinarian, biologist, or agency or institution does not hold a valid DEA permit.

## Interactions

**California Department of**
**Fish and Game**

-          AMDUCA with the Animal Welfare Act:
-   The IACUC cannot over-rule the requirements of AMDUCA.
-   Selection of any drug and its dosage and the route and means of administration of the drug, whether for "Labeled" or "Extra-Label" use for application to wildlife is subject to review by the IACUC.
-   The IACUC can mandate requirements for training and experience of users in the selection and administration of drugs to wildlife.
-   The IACUC can require reporting of adverse effects of drugs used in wildlife.

## Interactions

**California Department of**
**Fish and Game**

**Notes:**
In general, the government wildlife veterinarian is seldom able to be present to directly supervise all wildlife immobilizations, drug administrations, and research projects involving live animals, but may be held personally and professionally responsible for accidents or violations of the law. Biologists and the administrators of wildlife agencies want the veterinarian to facilitate their work, but not to complicate their activities. Thus, there is a natural tendency for tension to develop between the veterinarian and the wildlife biologist/agency. Dealing appropriately with this tension is a major challenge for wildlife veterinarians, both in the United States and worldwide.

Ideally, the wildlife biologist and the veterinarian should work together throughout the planning and execution phases.  

## AVMA Definition of a Valid Veterinarian-Client-Patient Relationship From: 1998 AVMA Directory

- The veterinarian has assumed the responsibility for making clinical judgements regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions.

**California Department of**
**Fish and Game**

- A valid veterinarian/client/patient relationship (VCPR) exists when _**ALL**_ of the following conditions have been met:

**Notes:**
David:

In preparation for presenting a draft veterinarian-client-patient relationship for wildlife, I have prepared slides showing the AVMA’s definition for clinical veterinarians.  There are three slides--which may not be necessary to include.

## AVMA Definition of a Valid Veterinarian-Client-Patient Relationship (Continued)

- The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s).  This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.

**California Department of**
**Fish and Game**

## AVMA Definition of a Valid Veterinarian-Client-Patient Relationship (Continued)

- The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen.

**California Department of**
**Fish and Game**

## Veterinarian-Client-Patient Relationship (VCPR) for Wildlife Veterinarians

- The agency assigns to the wildlife veterinarian the responsibility for making clinical judgements regarding the health and well being of the animal(s), the need for medical treatment, and the suitability of the drugs selected for treatment and the route of administration. The administrative officers of a natural resource agency grants sufficient authority to the wildlife veterinarian to permit his/her viewpoint on the issues of drug usage and animal well being to predominate in the planning, review, and execution of a study or activity involving wild animals.

**California Department of**
**Fish and Game**

**Notes:**
This is a draft veterinarian-client-patient relationship for wildlife veterinarians employed by natural resource agencies.  The “client” is the government agency with statutory authority over the wildlife in question.  By extension, the agency delegates “client” authority to wildlife biologists in its employ.

## Wildlife VCPR (Continued)

- The wildlife veterinarian should be in a position of authority to decide if a wildlife biologist is capable of using a drug in an appropriate manner and with reasonable expectation of safety for all concerned.  If a wildlife veterinarian cannot be present during the handling of the wild animal and the administration of the drugs, then the wildlife veterinarian should be closely involved in the planning, review and training process for a study or activity involving wildlife that requires the administration of drugs.  Similar policies should apply to activities where drugs are not used that cause stress or endanger the lives of animals but.

**California Department of**
**Fish and Game**

**Notes:**

Dave:
Are these too heavily oriented towards drug usage?  Should they be genericized to all activities?

## Wildlife VCPR (Continued)

- When present, the wildlife veterinarian has the authority to terminate any phase of the procedure, should in his/her professional opinion, the procedure place the life or well being of the wild animal unduly at risk.

**California Department of**
**Fish and Game**

## Wildlife VCPR (Continued)

- The wildlife veterinarian is informed of all drug usage on wild animals that are a part of the endorsed activities of the natural resource agency, is informed of all adverse reactions to drug usage on wild animals, and monitors and, in concert with the biologists, maintains records of all drug usage on wild animals.

**California Department of**
**Fish and Game**

## The AWA Loopholes

**“...****the IACUC shall conduct a review of those components of the activities related to the care and use of animals...; *****Provided, however*****, That field studies...are exempt from this requirement.”  Section 2.31 (d)**
**“*****Animal *****means...or any other warm-blooded animal intended for use in research....  This term excludes: Birds, rats of the genus *****Rattus***** and mice of the genus *****Mus*****...” Section 1.1 Definitions**

**California Department of**
**Fish and Game**

**Notes:**
IACUC = Institutional Animal Care and Use Committee

These clauses (along with one that exempts field sites from inspection) have been used by most natural resource agencies to avoid embracing the Animal Welfare Act.  

## The AWA Loopholes , Con’t.

**“****Field study” means any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study. (Section 1.1 Definitions)  (“Invasive procedure”, “...harm or materially alter the behavior...” definitions not given)**

**California Department of**
**Fish and Game**

**Notes:**
In fact, the exemption for “field studies” is not blanket.  “Invasive procedures” and “harm or materially alter the behavior” are not defined or delineated anywhere in the AWA.  The regulatory agency, Regulatory Enforcement and Animal Care (REAC) of APHIS, USDA, itself is not clear on which procedures would be considered “invasive” or that would “harm or materially alter the behavior” of wild animals.  For example, the October 1996 issue{12(3)} of SCWDS Briefs (a newsletter of the Southeastern Cooperative Wildlife Disease Study) describes a inquiry to REAC concerning whether venipuncture was classified as “invasive” failed to result in a clear decision.  A formal letter of inquiry to the agency was required to get  a firm decision (venipuncture was not ruled invasive).  However, most of us have experienced unfortunate instances where restraint required for venipuncture has resulted in death or injury to the animal.  Similarly, routine capture of wild animals, although considered benign may result in death or injury in the short term, and complications such as capture myopathy in the long term.  Clearly those results “harm or materially alter the behavior of the animals under study.”
Several publications have appeared which categorize procedures commonly in use by wildlife researchers as included or exempt from AWA oversight.  There is no clear justification for the derivation of these lists, and they should be used with caution.  

## Closing the Loopholes, Somewhat

**Most federal natural resource agencies are covered by the “Interagency Research Animal Committee’s  Principles (Federal Register, May 20, 1985, Vol. 50, No. 97) which extended coverage to **_**all**_** vertebrates.**
**Some state agencies have voluntarily extended coverage to all vertebrates.**
**Projects funded with NIH money must follow NIH Guidelines, which include all vertebrates.**
**Future changes to AWA will close loopholes.**
**Moral imperative.**

**California Department of**
**Fish and Game**

**Notes:**
It seems inevitable that future changes to the Animal Welfare Act will close the present loopholes.  As our university colleagues have found, compliance with the AWA is inevitable.  Progressive agencies have recognized that it is better to institute compliance now, that to suffer from public criticism when there research and management activities cause adverse publicity.  Compliance with the AWA and review of proposed activities by an IACUC is not a guarantee that adverse publicity will not result.  However, it does offer some protection to the agency and to the wildlife biologists involved.

## Policies Written  By Non-Veterinary Groups

_**Guidelines to the Use of Wild Birds in Research**_** **(Ornithological Council)
_**Guidelines for the Use of Live Amphibians and Reptiles in Field Research**_** **(American Society Ichthyologists and Herpetologists, The Herpetologists’ League, Society for the Study of Amphibians and Reptiles)
_**Guidelines for the Use of Fishes in Field Research**_** **(American Society of Ichthyologists and Herpetologists, American Fisheries Society, American Institute of Fisheries Research Biologists)
_**Animal Care Policy Manual**_ (USDA Animal and Plant Health Inspection Service)
_**Guide for the Care and Use of Laboratory Animals**_** **(National Research Council)

**California Department of**
**Fish and Game**

**Notes:**
Examples of policies written by professional organizations other than veterinary groups.  These policies are being used as the guidance documents by universities and government agencies.

Dave:
These can be found on the internet (I have a “Links” page on the WebPage that will take visitors to these policies).

I note that some of the societies that write these are actually using the internet version as the primary document.  That is, the electronic version will be updated more frequently than the paper version.  That’s a good idea.

I foresee the need for veterinary societies to write the following :
1. Guidelines for the Use of Wild Animals in Field and Laboratory Research.
2. A Model Animal Care and Use Policy for Wildlife Agencies.
3. A Model Policy for Compliance by Wildlife Agencies With the Controlled Substances and Animal Medicinal Drug Use Clarification Acts.
4. A Model Veterinarian-Client-Patient Relationship Statement for Wildlife Veterinarians.

## A Call to Action to Societies

**Lead, follow, or get out of the way.**

**California Department of**
**Fish and Game**

**Notes:**
(Dave:

This slide is optional, of course, but it leads into the next couple of slides.
The point here is that the “Collective” of zoo and wildlife veterinary organizations have not stepped into the forefront to lead the issues of wild animal usage in research, extra-label drug usage, and controlled substances.

Other societies are filling the void, at least in the animal care and use arena (see next slide).  While they may have some veterinary input in writing their policies, they are overwhelmingly written for the use and advantage of wildlife and fisheries biologists.  It should not surprise us (veterinarians) if our role is minimized by these policies.

## A Call to Action to Societies

**Develop model policies for  compliance with the Animal Welfare Act, the Controlled Substances Act, and  the Animal Medicinal Drug Use Clarification Act that can be used by natural resource agencies.**
**Develop a model definition of a valid veterinarian-client-patient relationship applicable to wildlife veterinarians.**
**Develop a guidance document for the handling and use of wildlife in research and management.**

**California Department of**
**Fish and Game**

## ADDITIONAL INFORMATION:

**California Department of**
**Fish and Game**

**ADDITIONAL INFORMATION:**

**www.absc.usgs.gov/research/vet**

## California Department of

**California Department of**
**Fish and Game**