TABLE OF CONTENTS
Topics | Sections |
1.1 What is the purpose of this chapter? 1.2 What is the scope of the chapters in Part 713, Aquatic Animal Health? 1.3 How does the Service use the chapters in Part 713 and the accompanying handbook? 1.4 What are the authorities for Part 713? 1.5 What terms do you need to know to understand the chapters in Part 713 and the handbook? | |
1.6 What is the Service’s general policy for aquatic animal health in the United States? | |
1.7 Who is responsible for implementing the aquatic animal health policy in 713 FW 1 and 2? | |
1.8 What are the standards by which Service aquatic animal health professionals implement the sampling and inspection provisions of this chapter? |
OVERVIEW
1.1 What is the purpose of this chapter? This chapter:
A. Provides an overview of the U.S. Fish and Wildlife Service (Service) aquatic animal health policy and standards and defines the terms you need to know to understand this chapter and 713 FW 2, Aquatic Animal Health Operations;
B. Introduces the regulatory framework, scope, and authorities on which the policy is based;
C. Describes the role of the Service and who is responsible for implementing the policy; and
D. Establishes the Handbook of Aquatic Animal Health Procedures and Protocols as the basis for Service efforts to contain, control, and minimize the impacts of aquatic animal pathogens and diseases on the natural resources of the United States.
1.2 What is the scope of the chapters in Part 713, Aquatic Animal Health?
A. This chapter and 713 FW 2 apply to all Service-managed facilities and field operations that hold, translocate, and propagate aquatic animals.
(1) Service-managed facilities include any land, water, and facilities the Service owns, leases, or otherwise controls unless a formal agreement is in place that delegates aquatic animal heath responsibilities to other entities. 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.
(2) The Service encourages application of these policies when managing aquatic species on non-Service-managed facilities. Non-Service-managed facilities include any land, water, and facilities not owned, leased, or otherwise overseen by the Service, but where others cooperate with the Service to manage, hold, translocate, and propagate aquatic animals.
B. This policy applies to Service personnel. Service personnel are those people the Service pays to work at facilities the Service owns, leases, or otherwise oversees. This includes permanent and temporary staff, volunteers, and contractors.
C. The chapters do not address piscicides.
1.3 How does the Service use the chapters in Part 713 and the accompanying handbook? The Service uses the chapters to establish the overall aquatic animal health policy and its accompanying handbook to explain how to implement the policy. The Aquatic Animal Health Policy Committee reviews and recommends revisions, as appropriate, to the chapters and the handbook every other year. The Assistant Director – Fish and Aquatic Conservation (FAC) reviews and approves revisions to the chapters before they are sent forward for surname and publication and reviews and approves revisions to the handbook.
1.4 What are the authorities for Part 713?
A. Anadromous Fish Conservation Act (16 U.S.C. 757a, et seq.).
B. Clean Water Act (33 U.S.C. 1251, et seq.).
C. Endangered Species Act (16 U.S.C 1531, et seq.).
D. Fish and Wildlife Act (16 U.S.C. 742a, et seq.).
E. Fish and Wildlife Coordination Act (16 U.S.C. 661, et seq.).
1.5 What terms do you need to know to understand the chapters in Part 713 and the handbook? See Exhibit 1, Glossary, for definitions of the terms we use in 713 FW 1 and 2 and the handbook.
SERVICE ROLE IN AQUATIC ANIMAL HEALTH
1.6 What is the Service’s general policy for aquatic animal health in the United States?
A. Service personnel must:
(1) Conduct aquatic animal activities in a way that assists in the prevention of the spread of aquatic animal pathogens into areas where they are not known to occur;
(2) Help eradicate, when feasible, certain serious aquatic animal pathogens; and
(3) Use procedures in the handbook to detect, control, and minimize the impact of aquatic animal pathogens that cannot be eradicated.
B. Service aquatic animal health professionals will collaborate with Native American Tribes, States, Federal agencies, international agencies, foreign governments, and other partners to organize and carry out programs that seek to promote, maintain, and manage aquatic animal health for the protection and promotion of U.S. fisheries, aquaculture, and aquatic natural resources.
C. As supported by a Service Fish Health Program (FHP), Service managers strive to hold, translocate, and propagate aquatic animals that uphold Service fish and aquatic conservation objectives.
(1) Service aquatic animal health professionals must inspect Service-managed aquatic animal facilities annually and primary broodstock broodstock
The reproductively mature adults in a population that breed (or spawn) and produce more individuals (offspring or progeny).
Learn more about broodstock facilities twice annually, maintain surveillance of all aquatic animals at Service-managed facilities for occurrences of pathogens and diseases, and complete sampling and testing prior to moving live aquatic animals, as described in this chapter and the handbook.
(2) Service managers must stock only aquatic animals that do not pose health threats to natural resources (e.g., are not undergoing an epizootic of a disease that would likely impact natural populations).
D. Service aquatic animal health professionals may conduct applied research on aquatic animal diseases to:
(1) Improve pathogen detection and disease diagnostic techniques;
(2) Develop procedures for hygiene, therapy, disease prevention, and pathogen eradication;
(3) Improve the disease resistance of cultured aquatic animals; and
(4) Study the prevalence and impact of diseases in free-ranging aquatic animals.
E. Service aquatic animal health professionals will make available, to the extent possible, the results of aquatic animal health studies to State, Tribal, and private sector cooperators and participate in international, national, and regional aquatic animal health cooperative agreements negotiated with States, Tribal governments, and aquaculture associations.
F. Service personnel must comply with all applicable Federal, State, and local laws and regulations governing the acquisition, use, storage, and disposal of drugs and chemicals for collecting, assessing, propagating, rearing, distributing, and maintaining the health and well-being of aquatic species at Service-managed facilities. Service-managed facilities must maintain up-to-date and accurate records for all drug and chemical use. When administering drugs and chemicals at Service-managed facilities, Service personnel must comply with the following:
(1) Service personnel are authorized to apply drugs (other than biologics) in or on aquatic species only if the drug is:
(a) Approved by the U.S. Food and Drug Administration (FDA) for such use;
(b) The subject of an FDA-authorized Investigational New Animal Drug (INAD) exemption, if not already approved;
(c) On FDA’s list of Low Regulatory Priority drugs, Deferred Regulatory Status drugs, or Index drugs; or
(d) Approved by FDA for a species other than the subject aquatic species (e.g., dog, beef cattle, and swine) when prescribed by a licensed veterinarian under extra-label drug use provisions, but only under the specific conditions of each use.
(2) All biologics (see Exhibit 1 for a definition) used on Service-managed facilities must be approved by the U.S. Department of Agriculture or covered by a valid U.S. Veterinary Biological Product Permit to import the product for general distribution and sale or be exempt from Federal regulation.
(3) To use an unapproved drug or chemical for conditions or diseases affecting federally listed threatened or endangered species, Service personnel must first obtain written permission from the Service’s FAC Aquatic Animal Drug Approval Partnership (AADAP). For additional information on AADAP, as well as general drug and chemical use guidance, visit the AADAP website.
(4) Before using a drug or chemical at Service-managed facilities for aquatic species, all drug and chemical use must have the approval of the appropriate FHP supervisor, and when required by law, the servicing veterinarian through a Veterinary Client Patient Relationship (VCPR). If certain drugs or chemicals are used regularly or multiple times within a year and do not require a prescription or Veterinary Feed Directive (VFD) (such as with recurring disinfectant or anesthetic use), then Service personnel only need to obtain and document approval for use annually. The FHP supervisor must approve this use. For the specified drugs or chemicals used regularly with FHP supervisor approval, Service personnel may submit necessary reports on an annual basis instead of for each daily or weekly use.
(5) This section does not apply to administering drugs and chemicals in controlled laboratory settings where there is no contact with propagated aquatic species or the potential for effluent discharge to public surface waters. See chapter 4 of the handbook for more guidance and implementation protocols and procedures.
G. The Fish Health Centers (FHCs) must commit to upholding the highest levels of quality and scientific integrity. When implementing the policy in 713 FW 1 and 2 and the handbook, FHCs should uphold the following policy and guidelines related to scientific integrity and information quality: Department of the Interior Manual (DM) chapter, Integrity of Scientific and Scholarly Activities (305 DM 3), the Service Manual chapter on Scientific Integrity and Scholarly Conduct (212 FW 7), and the Service’s Information Quality Guidelines. In addition, FHCs must adhere to the Department’s Code of Scientific and Scholarly Conduct (305 DM 3.7).
RESPONSIBILITY FOR AQUATIC ANIMAL HEALTH
1.7 Who is responsible for implementing the aquatic animal health policy in 713 FW 1 and 2? See Table 1-1.
Table 1-1: Responsibilities for the Aquatic Animal Health Policy
These Service personnel… | Are responsible for… |
A. The Director | Ensuring the appropriate approvals are in place for the implementation of this policy. |
B. Regional Directors | Ensuring the appropriate implementation of this policy in their Regions. |
C. The Assistant Director – FAC | Developing and maintaining the Aquatic Animal Health Policy and the handbook |
D. Assistant Regional Directors – FAC | (1) Ensuring that health inspections, sampling, and testing are completed as described in 713 FW 1 and FW 2 and the handbook; (2) Authorizing the transfer of gametes, fertilized eggs, or aquatic animals from and to Service primary broodstock facilities; (3) Authorizing operations in their Regions that are conducted under the Disease Eradication Plan, including authorizing quarantines as required to contain suspected or confirmed outbreaks of exotic diseases; (4) Resolving conflicts between this policy and other compacts, policies, agreements, guidelines, or contracts with other jurisdictional entities; and (5) Immediately notifying the Regional Director if informed by an FHP supervisor that a significant pathogen has been detected in the Region. |
E. FHP supervisors | (1) Providing and coordinating health services for all Service aquatic animal activities; (2) Conducting or overseeing aquatic animal health services in accordance with established cooperative agreements; (3) Completing aquatic animal health inspection, sampling, and testing; maintaining the original copies of results; and providing digital or hard copies to all involved parties (e.g., receiving facility, State for release, transfer, or other movement); (4) Immediately notifying the appropriate Assistant Regional Director, the Branch Chief of Hatchery Operations and Applied Science, the facility manager, and potentially affected Federal, State, and Tribal parties of any pathogen detected that would be likely to adversely impact Service aquatic animal programs by producing high mortality or by triggering movement restrictions, or that 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; (5) Directing field operations in situations requiring implementation of a Disease Eradication Plan; (6) Reviewing current knowledge of aquatic animal pathogens and diseases and recommending to the Aquatic Animal Health Policy Committee any changes to the policy in 713 FW 1 and 2 and accompanying handbook that would improve the Service’s ability to detect, eradicate, control, prevent, or minimize the impact of aquatic animal diseases and pathogens; and (7) Annually reviewing and updating Regional site-specific Aquatic Animal Health Management Plans as the handbook describes and sending them to the appropriate Assistant Regional Director. |
F. The Aquatic Animal Health Policy Committee (composed of one FHP supervisor from each Region and the National Coordinator for Aquatic Animal Health, Aquaculture, and Technology) | (1) Meeting at least annually to review these chapters, the accompanying handbook, and the regulations, to identify necessary changes; and (2) Recommending revisions to these chapters, the accompanying handbook, and the regulations to the Assistant Director – FAC. |
G. Service managers with responsibilities for overseeing aquatic resources | (1) Managing operations in compliance with this chapter, 713 FW 2, and the accompanying handbook; (2) Coordinating with the appropriate Service FHP supervisor at least 30 days prior to moving aquatic species to ensure that gametes, fertilized eggs, or aquatic animals (including carcasses) are shipped or accepted in compliance with this policy, area disease control programs, Regional stock transfer policies, and the regulations of other jurisdictions; and (3) Providing a disease history of any lot of aquatic animals to recipients upon request. |
AQUATIC ANIMAL HEALTH INSPECTION STANDARDS
1.8 What are the standards by which Service aquatic animal health professionals implement the sampling and inspection provisions of this chapter? Aquatic animal health professionals must:
A. Conduct sampling to ensure the integrity of sample collection, labeling, and preservation;
B. Issue an Inspection Report only when all sampling and laboratory work is performed according to procedures in 713 FW 1 and 2 and the handbook; and
C. Identify in the Inspection Report any inspection work that non-Service entities performed.