DIRECTOR'S ORDER #77-4:  USE OF PHARMACEUTICALS FOR WILDLIFE

                                         

 

 

Approved: _______________

                            Director

 

Effective Date:  _____________

 

Duration:  This Order will remain in effect until rescinded or superseded.

 

Contents:

1.  Background
2.  Purpose and Scope
3.  Authority to Issue this Director’s Order
4.  Policy, Requirements, and Responsibilities
4.1  Policy
4.2  Requirements
4.3  Responsibilities
5.  Additional Guidance

 

1.  BACKGROUND

 

Natural resource management and research programs conducted in national parks may require administration of pharmaceuticals to wildlife.  Pharmaceuticals commonly used in wildlife programs include anesthetic agents, sedatives, antibiotics, vaccines, contraceptives, anti-parasitic drugs, and euthanasia agents.  For the purposes of this Director’s Order only, the term “wildlife” means animals that are wild in their place of origin, as well as other wild-living or feral animals.[1] Many of these species cannot be safely restrained or handled without the use of pharmaceuticals.  Pharmaceuticals are also used to treat or prevent non-native diseases or diseases resulting from human intervention, diseases that threaten at-risk species, or animal diseases that threaten human health.  Contraceptives may be applied as a form of reproductive intervention to control wildlife populations.  Euthanasia agents may be administered when approved lethal control of wildlife is necessary.

 

Most of the pharmaceuticals used for wildlife are federally regulated to help safeguard human and animal health.  National Park Service staff must possess adequate knowledge and experience in the use of pharmaceuticals for wildlife to assure human safety and to provide an adequate standard for professional care.  

 

The use of vaccines and other veterinary biologics is regulated primarily by the Veterinary Biologics Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture; one exception is that contraceptive vaccines, as well as other contraceptive formulations, used in free-ranging wildlife are regulated by the Environmental Protection Agency (EPA).  The use of other pharmaceutical agents in animals (i.e., animal drugs) is under the jurisdiction of the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and the Food and Drug Administration Modernization Act of 1997.  Additional guidance is contained in the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994.  These laws and their implementing regulations govern the prescription of animal drugs and the extra-label use of drugs.  Extra-label (or off-label) use of drugs refers to the administration of an approved human or animal drug in a manner not in accordance with label directions.  Extra-label use of drugs for wildlife is often necessary because the drugs are not licensed specifically for use in these species.

 

Further, many of the drugs used for wildlife, particularly for field anesthesia, are controlled substances whose use is restricted by the Drug Enforcement Administration (DEA).  Controlled substances are narcotics and other dangerous drugs that are classified into five groups based on their potential for abuse and ability to cause psychic or physical dependence.  A high degree of proficiency is required to safely and effectively administer these drugs.  The Controlled Substances Act, as amended, requires an individual/agency to possess a DEA registration to purchase these controlled substances, and details requirements that govern recordkeeping and storage of controlled substances.

 

Finally, some pharmaceuticals, particularly new injectable anesthetics and contraceptives, are available for use prior to licensing to collect data that will be used in their registration.  These products are regulated by FDA as Investigational New Animal Drugs (INADs) or by EPA under an Experimental Use Permit (EUP).  Use of INADs and EUPs requires specialized authorization from the drug’s sponsor for application under a research protocol.

 

The care and use of animals in research is governed by the Animal Welfare Act.  If pharmaceuticals are administered as part of a research project, requirements of the Animal Welfare Act, including protocol review and approval by an Institutional Animal Care and Use Committee (IACUC), may apply.  Wildlife management activities are not regulated under the Animal Welfare Act; however, other standards and professional society standards do exist.

 

 

2.  PURPOSE AND SCOPE

 

The purpose of this Director’s Order and the accompanying Reference Manual 77-4 is to establish NPS operational policies and procedures for compliance with existing Federal laws, regulations, and guidelines governing the use of pharmaceutical agents for wildlife in national parks.  The section on “Chemical Immobilization and Sterilization Agents” from chapter 5 (specifically, pp. 5.69—5.71) of NPS-77 (May 1991), and a memorandum dated March 7, 1994, regarding “Service-wide Procedures for the Acquisition, Storage, and Use of Wildlife Immobilization and Anesthetic Drugs,” are superseded and replaced by this Director’s Order and Reference Manual 77-4.

 

As is the case with all components of the NPS Directives System, this Order is intended only to improve the internal management of the NPS and it is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, its departments, agencies, instrumentalities or entities, its officers or employees, or any other person.

 

 

3.  AUTHORITY TO ISSUE THIS DIRECTOR'S ORDER

 

The authority to issue this Director's Order and the associated Reference Manual is contained in 54 USC 100101 et seq. (the National Park Service Organic Act and related laws), and the delegations of authority contained in Part 245 of the Department of the Interior Manual.

 

Legal and regulatory requirements include:

 

 

 

4.  POLICY, REQUIREMENTS, AND RESPONSIBILITIES

 

This Director’s Order sets forth the policy, requirements, and responsibilities for administration or application of pharmaceuticals to wildlife within national parks.

 

4.1  Policy

 

The administration of pharmaceuticals to wildlife is a necessary component of some management and research activities conducted in the NPS.  It is our policy to administer pharmaceuticals to wildlife in a manner that is safe for humans; safe for animals (unless lethal outcome is the objective); adheres to humane standards; and is in accordance with NPS wildlife management policies and objectives.  Regardless of registration agency of drugs and vaccines, pharmaceuticals applied to wildlife in national parks will be under the supervision of a licensed veterinarian.  To implement this policy, NPS employees will comply with all provisions of this Director’s Order.

 

4.2  Requirements

 

4.2.1  For the safe and responsible use of pharmaceuticals for wildlife, the NPS will:

 

A.  Comply with FDA regulations on the use of drugs in animals.

 

1.  Prescription Drugs.  Nearly all drugs used for wildlife are prescription drugs.  Veterinary prescription drugs are restricted to use by or on the order of a licensed veterinarian under a valid veterinarian-patient-client relationship.  In the case of the NPS, this relationship triad consists of wildlife as the patient, a resource manager or scientist as the client, and NPS staff veterinarian or consulting veterinarian (e.g., qualified local practitioner, Federal or State agency veterinarian) as the veterinarian of record.  This formal relationship establishes that a licensed veterinarian assumes the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (NPS) agrees to follow the instructions of the veterinarian.  The veterinarian does not have to be onsite during use of the drugs, but he or she must be familiar with the species, herd, or local population, and if possible the individual animal treated.  This requirement may be most efficiently and effectively met through the use of protocols approved by the veterinarian of record.

 

2.  Extra-label Use of Drugs.  If a labeled drug that fully meets the need is available for use, it must be used for food-producing animals (animals that may be harvested for human consumption) and is recommended for use in other species.  However, most drugs administered to wildlife are applied on an extra-label basis.  AMDUCA specifies additional requirements for the extra-label use of drugs.  These include:

 

a.  Well-defined records that are maintained for two years:
   (1) The established name of the drug and its active ingredient.
   (2) The condition treated (e.g., capture for radio collaring).
   (3) The species treated.
   (4) The dosage administered.
   (5) The duration of treatment.
   (6) The number of animals treated.
   (7) The specified withdrawal time for drugs used in food-producing animals as advised by the prescribing veterinarian.

 

b.  Labeling requirements:
   (1) Name and address of prescribing veterinarian.
   (2) Established name of drug.
   (3) Directions for use.
   (4) Cautionary statements.
   (5) Withdrawal time for human consumption of food products from treated animals.

c.  Exclusion of the treated animal from the human food chain until the drug withdrawal time is met.  Wildlife that receive pharmaceuticals and may be consumed by humans must be identified (e.g., with an eartag) to notify individuals that may harvest the animal not to consume meat until the specified drug withdrawal time has elapsed.  Coordination with State wildlife management agencies is encouraged to identify potential “food-producing” animals (those that may be harvested for meat).

 

3.  Compounding Animal Drugs.  Compounding is defined as any manipulation to produce a dosage-form drug other than that provided for in the directions for use (e.g., freeze-drying a drug for reconstitution at a higher concentration).  Compounding from approved drugs by veterinarians and pharmacists (acting on a valid prescription) is allowed under certain circumstances.  The NPS will comply with FDA regulations on compounding, and specifically will not use compounded drugs freeze-dried by sources other than a veterinarian or pharmacist within the confines of a legitimate practice.

 

B.  Comply with agency regulations and the sponsor’s instructions on use of Investigational New Animal Drugs and Experimental Use Permits.

 

Records on the use of INADs and EUPs will be submitted to the sponsor of the investigation (i.e., that entity seeking drug approval), and all other reporting requirements of FDA (as set out in 21 CFR part 511) or EPA will be met.

 

C.  Promote humane use of pharmaceuticals for wildlife.

 

The NPS will comply with the Animal Welfare Act as required when pharmaceuticals are applied to animals used in regulated activities, such as research, teaching, and exhibition.  For the use of pharmaceuticals in animals for management activities, the NPS will comply with acceptable humane standards as described in Reference Manual 77-4.

 

D.  Ensure appropriate disposition of carcasses of wildlife that have received pharmaceuticals.

 

Exclusion of carcasses from the human food chain is addressed above in section 4.2.1.A(2)(c).  Further, the prescribing veterinarian should provide instructions that must be followed to reduce or eliminate potential food chain effects to other animals. Adherence to labeled environmental warnings (e.g., on pentobarbital-containing euthanasia agents to prevent secondary poisoning of scavenger species) is required. 

 

 

E.  Require training and qualification for individuals who perform remote delivery of pharmaceuticals.

 

Applicable Department of the Interior and NPS firearms policies will be followed if firearms are used to deliver pharmaceuticals.  Employees must receive training and qualify with each type of firearm or other remote delivery system used.  In the absence of NPS guidance, park superintendents or regional natural resource managers are delegated authority to establish qualification training for the use of remote delivery systems.  Park managers, in consultation with the park’s firearms officer and natural resource manager or scientist, will establish training requirements based on specific needs and uses to ensure that employees are properly qualified to safely use remote delivery systems.  Park superintendents or regional natural resource managers must require, and may offer, equivalent training for NPS cooperators (e.g., State or other Federal agency staff) who use remote delivery systems in national parks.

 

F.  Authorize only well-qualified individuals to administer pharmaceuticals.

 

Pharmaceuticals are regulated because of their toxicity or other potential for harmful effects.  Through compliance with FDA regulations and establishment of a valid veterinarian-patient-client relationship, adequate information to safely and effectively administer non-controlled pharmaceuticals should be provided by the veterinarian to the client.

 

4.2.2  In addition to the above, for the safe and responsible use of anesthetics or controlled substances for wildlife, the NPS will:

 

A.  Comply with DEA regulations on use of controlled substances.

 

Parks with a need to acquire or store anesthetics or controlled substances, or to administer them to wildlife, will appoint a park practitioner.  Park practitioners may obtain controlled substances under a prescription from an individual holding an appropriate DEA license (e.g., an NPS or local veterinarian) or may register directly with the DEA.  DEA registration of NPS non-medical personnel is for wildlife management and research activities only.  Although non-veterinarians licensed by the DEA may legally acquire and possess controlled substances, they may not administer these drugs in national parks without a valid veterinary-patient-client relationship.  Security and storage requirements for controlled substances will be in compliance with 21 CFR 1301.71 to 1301.76; recordkeeping will be in compliance with the DEA requirements under 21 CFR part 1304, and the requirements under 21 CFR part 1305 regarding DEA Official Order Forms.

 

B.  Require certification of individuals to administer anesthetics or controlled substances to wildlife.

 

Many anesthetics and controlled substances are potentially lethal to humans if accidental exposure occurs.  Further, controlled substances and techniques used for field anesthesia pose a concern for animal welfare.  Therefore, all NPS employees, agents, or cooperators who use anesthetics or controlled substances for wildlife management or research purposes must obtain certification in accordance with requirements described in Reference Manual 77-4.  Certification will be obtained through completion of training programs or demonstration of appropriate knowledge, experience, and skills in wildlife anesthesia and administration of controlled substances (e.g., pharmacology, human safety, animal safety and humane standards, regulations and legal requirements, techniques of field anesthesia, euthanasia).  Superintendents or regional natural resource managers must ensure appropriate training, experience, and veterinary oversight of individuals who administer anesthetics and controlled substances to wildlife. Approval may be granted to NPS cooperators (e.g., State or other Federal agency staff) based on certification from the cooperating agency if NPS requirements are adequately met.

 

C.  Require protocols for the use of anesthetics or controlled substances for wildlife.

 

Prior to the use of anesthetics or controlled substances, parks will have in place an approved protocol for (1) the individual wildlife species, or (2) the project.  For routine management activities (e.g., relocation, euthanasia) development of blanket protocols is encouraged.  In the case of research projects, an Institutional Animal Care and Use Committee (IACUC) approved study protocol is generally sufficient.  Protocols will be developed by the park, or researcher, usually with assistance from the veterinarian of record or based on NPS templates.  Protocols will be approved by the park superintendent or regional natural resource manager, and by the veterinarian of record.

 

4.3  Responsibilities

 

A.  Associate Director, Natural Resource Stewardship and Science

 

1. Issues, and revises as appropriate, Reference Manual 77-4, which may provide additional technical guidance, procedures, detailed explanation of program areas, and requirements.

2.  Ensures that NPS Service-wide veterinarians hold state veterinary licensure in at least one state and maintain as required DEA controlled substances registration.

 

B.  Regional Director

 

1.  Ensures that standards are uniformly applied to all parks within the region.

2.  Within existing budgets and priorities, ensures that funds are available commensurate with demands and needs for veterinary consultation and staff training.

 

C.  Regional Natural Resource Manager

 

1.  Ensures that programs planned or supervised from the regional office use trained employees with appropriate veterinary consultation and, as required DEA controlled substances registration.

2.  Except where otherwise established, approves personnel to perform park duties based on the personnel having obtained relevant training.

 

D.  Superintendent

 

1.  Ensures that this Director’s Order and Reference Manual 77-4 are incorporated programmatically into park operations.

2.  Except where otherwise established, approves personnel to perform park duties based on the personnel having obtained relevant training.

3.  Appoints the park practitioner.

4.  Approves protocols for the use of anesthetics or controlled substances for wildlife in the park.

 

E.  Park Practitioner

 

1.  Obtains training on the use of pharmaceuticals and has substantial experience on the use of anesthetics and controlled substances in animals.

2.  Establishes, or delegates to resource manager, veterinarian-patient-client relationship for use of pharmaceuticals and adheres to all instruction from the prescribing veterinarian.

3.  Ensures that all controlled substance activities carried out are in compliance with DEA regulations and requirements.

4.  Ensures appropriate protocols are in place prior to use of pharmaceuticals.

 

F.  Resource Manager

 

1.  Plans and implements wildlife programs in a safe, effective, and humane manner, in part by developing protocols for the use of anesthetics or controlled substances for wildlife.

2.  Obtains training for self and those under his/her supervision.

3.  As requested, establishes veterinarian-patient-client relationship for use of pharmaceuticals.

 

G.  Biological Resources Division’s Service-wide Wildlife Veterinarian

 

1.  Recommends policy to Associate Director, Natural Resource Stewardship and Science, on the use of pharmaceuticals for wildlife in units of the National Park System.

2.  Provides technical assistance (consultation or on-site assistance) on the development of protocols and the use of pharmaceuticals for disease treatment and prevention, anesthesia, euthanasia, and other veterinary applications.

3.  Provides training, or assists in identifying training opportunities, for NPS staff and collaborators to obtain required knowledge and experience for the use of anesthetics or controlled substances for wildlife in national parks.

4.  As requested by parks or regions, and as deemed appropriate and feasible by the veterinarian, serves as the veterinarian of record, or assists in developing a relationship between the park and a consulting veterinarian.

 

5.  ADDITIONAL GUIDANCE

 

Until Reference Manual 77-4 is issued, any provisions of the Natural Resources Management Guideline (NPS-77) not inconsistent with this Director’s Order will be in place.

 

----------------End of Director's Order----------------

 

 



[1] Administration of pharmaceuticals to NPS-owned domesticated animals should be by, or under the supervision of, a licensed veterinarian in the standard course of veterinary practice.