DIRECTOR'S ORDER #77-4:
USE OF PHARMACEUTICALS FOR WILDLIFE
[14-day review draft. Send comments to Margaret Wild by 7/21/02.]
Natural resource management and research programs conducted in units of the National Park System may require administration of pharmaceuticals for wild animals. Pharmaceuticals commonly used in wildlife programs include anesthetic agents, antibiotics, vaccines, contraceptives, and anti-parasitic drugs. Many wildlife 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 diseases of animals that threaten human health. Contraceptives may be applied to control wildlife populations.
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 continued use of pharmaceuticals for wildlife is jeopardized if federal regulations or the public trust are violated.
The use of vaccines and other veterinary biologics is regulated by the Veterinary Biologics Staff, Animal Plant Health Inspection Service, U.S. Department of Agriculture. 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 drug in a manner not in accordance with label directions. Extra-label use of drugs for wildlife is often required because the drugs are not licensed specifically for use in these species.
Further, many of the drugs used for wildlife, particularly field anesthesia, are controlled substances whose use is restricted by the Drug Enforcement Agency (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 have special DEA registration to purchase these controlled substances, and details requirements that govern recordkeeping and storage of controlled substances.
Finally, some pharmaceuticals, particularly contraceptives and new injectable anesthetics, 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). Use of INADs requires specialized authorization under a drug research project.
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 (e.g., to anesthetize animals for marking as part of a research project, administer a vaccine 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), apply. Wildlife management activities are not federally regulated. However, professional society standards do exist.
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 the National Park System. NPS-77 Guidelines on Chemical Immobilization and Sterilization Agents and a memorandum dated March 7, 1994, regarding Service-wide Procedures for the Acquisition, Storage, and Use of Wildlife Immobilization and Anesthetic Drugs are superceded and replaced by this Director's Order and Reference Manual #77-4.
3. AUTHORITY TO ISSUE THIS DIRECTOR'S ORDER
The authority to issue this Director's Order and the associated Reference Manual is contained in 16 USC 1 through 4 (the National Park Service Organic Act) and the delegations of authority contained in Part 245 of the Department of the Interior Manual.
Other legal and regulatory requirements are contained in the:
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 units of the National Park System.
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 and animals, adheres to humane standards, and is in accordance with NPS wildlife management philosophy. To implement this policy, NPS employees will comply with all provisions of Director's Order #77-4.
For the safe and responsible use of pharmaceuticals for wildlife, the National Park Service will:
A. Comply with FDA regulations on the use of drugs in animals.
Extra-label Use of Drugs
Compounding Animal Drugs
B. Comply with FDA regulations and the sponsor's instructions on use of Investigational New Animal Drugs.
Records on the use of INADs will be submitted to the sponsor, and all other FDA reporting requirements (as defined in 21 CFR 511) will be met.
C. Promote humane use of pharmaceuticals for wildlife.
NPS will comply with the Animal Welfare Act if pharmaceuticals are used in animals on research projects. NPS will comply with acceptable humane standards and professional society guidelines for the use of pharmaceuticals in management activities.
D. Require firearms training and qualification for individuals who perform remote delivery of pharmaceuticals.
Remote delivery systems for pharmaceuticals (e.g., dart guns, biobullet guns) are considered firearms by the NPS. All employees whose duties require the use of firearms must qualify, at a minimum, semi-annually with the type(s) of firearm(s) used. Firearms training must include safety, marksmanship, maintenance, storage, performance, limitations of weapons, accountability and control, and security. Park managers are delegated authority to establish qualification courses for the use of remote delivery systems. Park managers in consultation with the park's firearms officer and natural resources manager or scientist will establish approved courses of fire for qualification with these firearms based on specific needs and uses. Park Superintendents or Regional Managers may grant certification to NPS cooperators (e.g., state or other federal agency staff) based on the cooperating agency's requirements.
E. Authorize only well-qualified individuals to administer pharmaceuticals.
Prescription drugs 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.
In addition to the above, for the safe and responsible use of anesthetics or controlled substances for wildlife, the National Park Service will:
F. Comply with DEA
regulations on use of controlled substances.
G. 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, techniques of field anesthesia, euthanasia). Superintendents or Regional Managers may grant certification to NPS cooperators (e.g., state or other federal agency staff) based on the cooperating agency's requirements.
H. Require protocols for the use of anesthetics or controlled substances for wildlife.
Protocols for the use of anesthetics or controlled substances for wildlife will be developed. These protocols will include the objectives of the program, methodology, and safety procedures. In the case of research projects, this would be accomplished through the use of an Institutional Animal Care and Use Committee (IACUC) approved study protocol. Use of blanket protocols for routine management activities (e.g., nuisance animals, transplantations) is encouraged. Protocols will be approved by the park superintendent or Regional Manager, and by the veterinarian of record.
B. Regional Director
C. Regional Program Manager
E. Resource Manager
F. Park Practitioner
G. NPS Staff Wildlife Veterinarian
5. ADDITIONAL GUIDANCE
The Associate Director, Natural Resource Stewardship and Science, will
prepare and issue Reference Manual #77-4, which may provide additional
technical guidance, procedures, detailed explanation of program areas,
and requirements. 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.
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