he following terms are used in the aquatic animal health policy (713 FW 1, 713 FW 2, and the U.S. Fish and Wildlife Service (Service) Handbook of Aquatic Animal Health Procedures and Protocols):
Adults: Sexually mature aquatic animals, regardless of age.
Approved drugs: Drugs for which the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine has assessed the safety and efficacy, and for which a definition in the Federal Register and Code of Federal Regulations has been provided as approved or conditionally approved for use asper the conditions stated on the drug label.
Aquatic animal: For 713 FW 1, 713 FW 2, and the handbook, “aquatic animal” means any animal, excluding birds and mammals, which spends some portion of its life cycle in fresh, brackish, or salt water.
Aquatic animal activity: Any Service activity that involves the capture, holding, propagation, transfer, or release of aquatic animals or their gametes.
Aquatic Animal Drug Approval Partnership (AADAP) Program: A Fish and Aquatic Conservation/Headquarters (FAC/HQ) Branch located on the campus of the Bozeman Fish Technology Center in Bozeman, Montana. The mission of the AADAP Program is “Working with our partners to conserve, protect, and enhance the Nation’s fishery resources by coordinating activities to obtain FDA approval for drugs, chemicals, and therapeutants needed in aquaculture and fisheries management programs.” For additional information on AADAP, as well as establishing a good source of general drug and chemical use guidance, visit the AADAP website.
Aquatic animal health professional: A Service employee who meets the educational and professional standards equivalent to those of the Fish Health Section of the American Fisheries Society for Fish Health Inspector or Fish Pathologist.
Biologic: As defined by the U.S. Department of Agriculture Center for Veterinary Biologics (CVB), the term “veterinary biologic” describes a vaccine, bacterin, antiserum, diagnostic kit, or other product of biological origin that is used to prevent, treat, or diagnose an animal disease. These products generally work through some immunological mechanism or process. As it pertains to biologics, the CVB has jurisdictional authority for their licensing and all aspects of regulatory compliance.
(1) Antiserum: A blood serum that contains antibodies against specific pathogens and is used to stimulate immunity to specific diseases.
(2) Bacterin: A suspension of killed or weakened bacteria used as a vaccine.
(3) Vaccine: An antigenic preparation used to establish immunity to a disease. Vaccines can be prophylactic (e.g., to prevent or ameliorate the effects of a future infection by any natural or "wild" pathogen) or therapeutic (e.g., vaccines against some forms of cancer). Vaccines may be living, weakened strains of viruses or bacteria that intentionally give rise to asymptomatic-to-inconsequential infections. Vaccines may also contain killed or inactivated organisms or purified products derived from them. Vaccines fall into one of several groups, including, but not limited to, inactivated, live-attenuated, toxoids, subunits, conjugates, recombinant-vectors, and DNA vaccines.
Broodstock facility: A hatchery or other facility that maintains a population of aquatic animals onsite that will be used to provide fertilized eggs, gametes, and fingerlings for the site’s use or for shipment to other facilities (also see primary broodstock facility).
Captive broodstock broodstock
The reproductively mature adults in a population that breed (or spawn) and produce more individuals (offspring or progeny).
Learn more about broodstock : Aquatic animals maintained or reared in captivity for the production of gametes.
Chemical: A compound or substance that has been purified or prepared.
Confirmatory test: A second and conclusive procedure for the identification of an isolated listed pathogen. Confirmatory tests are tests in the latest American Fisheries Society Fish Health Section guidance, World Organization for Animal Health Aquatic Manual, or peer-reviewed literature.
Cooperative agreements: The legal instrument reflecting a relationship between the U.S. Government and a State, Tribe, local government, or other recipient when:
· The principal purpose of the relationship is to transfer a thing of value to the State, Tribe, local government, or other recipient to carry out a public purpose of support or stimulation authorized by a law instead of acquiring (by purchase, lease, or barter) property or services for the direct benefit of the U.S. Government; and
· Substantial involvement is expected between the executive agency and the State, Tribe, local government, or other recipient when carrying out the activity contemplated in the agreement.
Deferred regulatory status drug: Substance the FDA defines as being a drug, but which is not regulated at this time, and until further notice FDA chooses not to regulate. The only two such drugs as they apply to 713 FW 1 and 2 and the handbook are copper sulfate and potassium permanganate.
Diagnostic: Examination (targeting moribund animals) to determine disease etiology. The Service aquatic animal health official will note in the “Remarks” section of the Fish Health Inspection Report if diagnostic samples are used as part of an annual health inspection.
Drug: As defined by the Federal Food, Drug, and Cosmetic Act (FD&C), the term "drug" means the following:
· Articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them;
· Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
· Articles (other than food) intended to affect the structure structure
Something temporarily or permanently constructed, built, or placed; and constructed of natural or manufactured parts including, but not limited to, a building, shed, cabin, porch, bridge, walkway, stair steps, sign, landing, platform, dock, rack, fence, telecommunication device, antennae, fish cleaning table, satellite dish/mount, or well head.
Learn more about structure or any function of the body of humans or other animals; or
· Articles intended for use as a component of any articles specified in the three clauses above.
In addition to these FD&C definitions, and as they apply to 713 FW 1 and 2 and the handbook, biologics under the jurisdiction of U.S. Department of Agriculture’s CVB are classified as drugs.
Emerging disease or pathogen: An aquatic animal disease or pathogen not previously known to occur in a given population or which is increasing in incidence in a previously known population.
Enzootic: A disease or pathogen that is known to occur within well-defined geographic boundaries.
Epizootic: A rapid and persistent increase in morbidity or mortality, or both (significantly above normal levels) in a given population by a virulent disease agent during a specific period of time as determined by a Fish Health Program (FHP) supervisor. This definition does not specify the rate and period of persistence because these are population- and pathogen-specific.
Exotic disease or pathogen: An aquatic animal disease or pathogen strain not previously known to occur in a given geographical area in the United States. It requires a historical absence of the pathogen or disease using adequate detection methods as determined by the FHP supervisor.
Extra-label drug use (prescription): The prescription of a drug by a veterinarian as allowed by FDA and State regulations for a disease or species that is not currently on the label of the approved product. Extra-label prescriptions may only be written for FDA-approved drugs and only within the context of a valid veterinary-client-patient relationship. For additional information, visit the Aquatic Animal Drug Approval PartnershipProgram website.
Facility: Any location that is used for the specific purpose of holding aquatic animals or gametes, or both, and can be either indoors or outdoors, or both.
Fish Health Center (FHC): FHCs are at the core of the Service’s Aquatic Animal Health Program and are located across the United States. FHCs are staffed with aquatic animal health professionals whose scientific and technical expertise is used to ensure the health, survival, restoration, and enhancement of fish and other aquatic species in support of national and Regional priorities. Among a broad array of other responsibilities, FHC staff detect and monitor pathogens, provide timely information and recommendations to fisheries managers so that they can make informed conservation and management decisions, and investigate emerging animal health issues that threaten the health and well-being of all aquatic species.
Fish Health Program (FHP): An FHP is a Regional Fish Health Center or equivalent staffed or supervised by Service aquatic animal health professionals.
Free ranging broodstock: Aquatic animals of any species captured from the wild for spawning.
Fungicide: A chemical developed to selectively kill fungi, molds, and other related non-photosynthesizing plants.
Herbicide: A chemical developed specifically to kill terrestrial or aquatic plants. Most herbicides selectively eradicate specific plant species or groups, while leaving all others unharmed. For example, algaecides can be effective for the eradication of undesirable aquatic plants.
Index drugs: Drugs that CVM has placed on the “Index List” of drugs for use in/on aquatic species as a result of data reviewed by both an outside expert panel and CVM, and which are determined to be safe and effective. Index drugs are not approved drugs as defined by the FD&C Act. CVM has defined Index drugs under the Minor Use and Minor Species Animal Health Act of 2004 as legally marketable by the manufacturer/distributor named within the “Index List” for that specific drug. To view the “Index List,” visit the FDA website.
Inspection: A statistically based onsite sampling of all lots of aquatic animals on the facility that a Service aquatic animal health professional performs or supervises, with subsequent examination of the collected tissues and fluids for the detection of listed pathogens in accordance with procedures in 713 FW 1 and 2 and the handbook. Monitoring and diagnostic results may contribute to inspection sampling requirements. Service aquatic animal health officials must report inspection results on a Fish Health Inspection Report
Investigational New Animal Drug (INAD) exemption: An official exemption that the FDA issues to a drug company or other entity allowing for the use of an unapproved drug under strict conditions. The exemption permits the generation of data to support a New Animal Drug Application (NADA), the release or slaughter (i.e., “slaughter authorization”) of food animals treated with the investigational or experimental drug, and the legal interstate transportation of the investigational drug. Any drug that is the subject of a valid INAD is an “investigational drug.” For additional information on available INADs and how to participate in Service’s National INAD Program, visit the AADAP website on the topic.
Isolation: Separating one group of aquatic animals from others. This could be isolation of sick aquatic animals, or those with unknown disease status, from others within or outside the same rearing area.
Laboratory: A building, part of a building, or other place that provides controlled conditions and is equipped to conduct scientific or technological tests, investigations, or experiments.
Listed pathogen: A pathogen of concern that is placed onto the lot’s inspection plan and Fish Health Inspection Report.
Listed Pathogen Not Detected (LPND): When no pathogen on the lot’s inspection pathogen list is detected.
Lot: A group of cultured aquatic animals of the same species, of the same year class, originating from the same spawning population, and sharing the same water supply.
Low Regulatory Priority (LRP) drugs: Compounds that FDA defines as drugs that are not approved and that FDA is not likely to approve, but (based on information provided to FDA) are drugs for which CVM will not likely take any regulatory action (i.e., prosecute the user of such an unapproved drug) if used under the conditions specified in FDA’s published list of LRP drugs. For additional information and a list of LRP drugs, visit the AADAP website on the topic.
Monitoring: Periodic sampling and disease detection work that a Service aquatic animal health professional performs or supervises in accordance with procedures set forth or referred to in 713 FW 1-2. When monitoring is used as part of an annual health inspection, a Service aquatic animal health professional must document this in the "Remarks" section of the Fish Health Inspection Report.
Moribund: Severely ill and at the point of death.
Movements: Relocating aquatic animals, including on-station releases, transfers between facilities, and relocations of wild populations.
National Pollutant Discharge Elimination System (NPDES) permit: A permit that the U.S. Environmental Protection Agency (EPA) or a State permit program issues for discharge of any pollutant under section 402 of the Clean Water Act (33 U.S.C.1342.) For additional information on NPDES permitting, see the EPA website.
Pathogen: A bacterium, parasite, virus, or other microorganism that can cause disease.
Pathogen strain: A bacterium, parasite, virus, or other microorganism that differs phenotypically (e.g., host-specificity, virulence, etc.) and genotypically (i.e., unique genetic identity) from other pathogens of the same taxonomic group.
Pesticide: Under the Federal Insecticide, Fungicide, and Rodenticide Act: (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest; (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and (3) any nitrogen stabilizer. We do not use the term ‘‘pesticide’’ to include any article that is a ‘‘new animal drug’’ within the meaning of section 201(w) of the Federal Food, Drug, and Cosmetic Act, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 201(x) of the Act (21 U.S.C. 321(x)) bearing or containing a new animal drug.
Piscicide: A type of pesticide that is lethal to fish and typically is used to eradicate non-native fish species.
Prevalence: The proportion of detectable cases of a disease or disease agent (i.e., pathogen) present in a population at a given time.
Primary broodstock facility: A hatchery or other facility whose primary role is to maintain onsite resident populations of salmonids that will be used to provide fertilized eggs and gametes for the National Broodstock program.
Quarantine: Maintaining a group of aquatic animals in isolation with no direct or indirect contact with other aquatic animals to allow observation for a specified length of time and, if appropriate, testing and treatment, including proper treatment of the effluent water and facility biosecurity measures in place.
Screening test(s): The survey for pathogen(s) in a population by means of a test, assay, or other laboratory procedure. Because the results of a screening test may have a high sensitivity but low specificity, they may provide presumptive identification of an agent, which will require a different, more sensitive test for confirmation. Screening tests are tests in the latest American Fisheries Society Fish Health Section guidance, World Organization for Animal Health Aquatic Manual.
Sentinel animal: An animal that is placed in a given environment and then monitored to find out if an infectious disease or other harmful agent is present in that environment.
Service-managed facilities: Any land, water, or facilities the Service owns, leases, or otherwise controls. These properties include, but are not limited to, National Fish Hatcheries, Fish Technology Centers, Fish Health Centers, Fish and Wildlife Conservation Offices, National Wildlife Refuges, and Ecological Services Field Offices.
Significant pathogen: A pathogen, including an emerging disease or pathogen or an exotic disease or pathogen, that would likely adversely impact Service aquatic animal programs by producing high mortality or by triggering movement restrictions, or that, if detected, would change the status of a recognized disease zone or compartment in a manner that would restrict movements by other entities, including those of Service partners.
Special case aquatic animals: Aquatic animals for which standard testing procedures either do not exist or may not be appropriate due to the species involved or the limited number or condition of the population. For example, this may include a threatened or endangered species.
Statistically based sampling: The collection by a Service aquatic animal health professional, or their designated Service agent, of appropriate aquatic animal tissue or fluid samples, on a lot-specific basis, in sufficient numbers to meet sampling criteria for listed pathogens as required by 713 FW 1-2 and the handbook.
Stock: That portion of an aquatic animal population sharing a common gene pool and, for aquatic animal health purposes, a common environment.
Surveillance: The formal health examination (e.g., inspections, monitoring, diagnostics, and non-lethal techniques) of aquatic animals by Service aquatic animal health professionals.
Veterinarian/Client/Patient Relationship (VCPR): According to the FDA, a VCPR exists when:
1) The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions;
2) 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; and
3) The veterinarian is readily available, or has arranged for emergency coverage, for followup evaluation if there are adverse reactions or a failure of the treatment regimen.
Note that the individual State Veterinary Boards may have their own requirements or definitions of a VCPR. Individual State VCPR requirements may be more restrictive than what FDA provides, but not less restrictive. For more information and a listing of VCPR regulations and primacy by State, visit the FDA website.
Veterinary Feed Directive (VFD) drug: New animal drugs intended for use in or on animal feed that are limited to use under the professional supervision of a licensed veterinarian. Any animal feed containing a VFD drug can only be fed to animals based on an order, called a VFD, issued by a licensed veterinarian under a valid VCPR. For more information on VFD drugs, visit the FDA website on VFD drugs. For more information on the extra-label use of VFD drugs, visit the FDA website on extra-label use.
Watershed: A drainage system of connected rivers, lakes, or streams, or a combination thereof, confined to a limited geographic basin.