Aquatic Animal Health Operations

TABLE OF CONTENTS

OVERVIEW

2.1 What is the purpose of this chapter? This chapter describes managerial and technical responsibilities related to aquatic animal health, provides systems to monitor the range and distribution of selected aquatic animal pathogens, establishes minimum standards for inspection and monitoring activities, and delineates required aquatic animal health management and reporting activities, all of which are part of the U.S. Fish and Wildlife Service’s (Service) aquatic animal health policy.

2.2 What is the scope of this chapter? See 713 FW 1 for information about the scope of the chapters in Part 713 and the accompanying handbook, U.S. Fish and Wildlife Service Handbook of Aquatic Animal Health Procedures and Protocols.

2.3 What terms do you need to know to understand the chapters in Part 713 and the handbook? See Exhibit 1, 713 FW 1, Glossary, for the definitions of terms used in Part 713 and the accompanying handbook.

2.4 What are the authorities for this chapter? See 713 FW 1 for a list of authorities for both chapters in Part 713 and the handbook.

AQUATIC ANIMAL HEALTH MANGEMENT PLAN

2.5 What is an Aquatic Animal Health Management Plan?

A. A Fish Health Program (FHP) supervisor must prepare an Aquatic Animal Health Management Plan (Plan) to provide an annual overview of aquatic animal health activities for all aquatic animals held, translocated, and propagated by a Service-managed facility or involving a Service-managed wild population. No component of a Plan can compel a veterinarian to violate any aspect of U.S. Food and Drug Administration (FDA) rules or the Veterinary Practice Act of the pertinent State.

B. The FHP supervisor prepares or oversees preparation of such a Plan for each facility or managed wild population. The Plan must include the following components (refer to the handbook for additional information):

(1) Annual facility inspection plan,

(2) Lot-specific disease management plan, and

(3) Biosecurity plan to minimize the transmission of pathogens onto and within a facility or site.

C. The FHP supervisor must review Plans annually or more often when the need arises.

CRITERIA, REQUIREMENTS, AND RESTRICTIONS

2.6 What are the inspection requirements, criteria, and general instructions for aquatic animal health surveillance?

A. Inspections at Service-managed facilities. Aquatic animal health professionals must complete Service facility inspections for aquatic animal health at least annually at all Service-managed properties and field operations that hold, translocate, and propagate aquatic animals. The inspection remains valid no longer than 1 year from the time the aquatic animal health professional signs the Inspection Report. The Plan (or the disease risk assessment) may require more frequent testing. Service aquatic animal health professionals must conduct sampling on a lot-by-lot basis with samples from each lot distinctively marked, maintained, and processed separately.

B. Selection of inspection pathogens. Aquatic animal health professionals must select inspection pathogens based on the following:

(1) Endemic pathogens that have caused disease in a lot at the facility within the last 5 years.

(2) Pathogens required by applicable Federal, State, Tribal, inter-jurisdictional, or foreign aquatic animal health protection laws, regulations, or guidelines.

(3) Pathogens in Appendices II and III of the handbook, if applicable.

(4) Emerging or exotic pathogens not covered by subsections B(1) - (3) above, when appropriate.

C. General instructions for inspection sampling.

(1) Selection of animals for samples. Aquatic animal health professionals must select animals for samples as described in the most current American Fisheries Society (AFS) Fish Health Section guidance.

(2) Special case aquatic animals. Sampling must be based on a disease risk assessment and coordinated with the Service personnel and cooperators involved in the actions. The FHP supervisor must determine sample size, tissue type (e.g., non-lethal samples or sentinel animals), and laboratory methodologies in consultation with the appropriate involved entities and consistent with the disease risk assessment.

(3) Sampling schemes.Service personnel must conduct all sampling as described in this chapter and the handbook unless otherwise specified within the Plan, and according to the latest AFS Fish Health Section guidance. 

(4) Minimal sampling criteria for all Service activities. Service personnel must conduct all Service sampling activities in compliance with applicable Federal, State, Tribal, inter-jurisdictional, and foreign aquatic animal health protection guidelines and regulations. Prior to moving live aquatic animals, employees must conduct sampling and testing of the lot for pathogens on an inspection plan at the 5% assumed pathogen prevalence level at a minimum, unless deemed special case aquatic animals (see Exhibit 1, 713 FW 1 for a definition of “special case aquatic animals”). If unforeseen circumstances with potentially harmful effects imminent to hatchery animals or a distinct wild population(s), such as, but not limited to natural disasters, do not allow for an inspection or risk assessment to occur prior to the movement taking place, a Regional Director may approve the movement without an inspection or risk assessment.

(5) How samples are processed. Service personnel must process samples according to the procedures described in the most recent AFS Fish Health Section guidance. When exceptions to AFS Fish Health Section guidance protocols are required for compliance with applicable Federal, State, Tribal, inter-jurisdictional, or foreign aquatic animal health protection guidelines and regulations, or if AFS Fish Health Section guidance does not provide protocols for a targeted pathogen, personnel should use the following protocols to comply in the following order of priority:

     (a) World Organization for Animal Health Aquatic Manual.

     (b) Protocols from peer-reviewed literature.

2.7 What additional restrictions pertain to the movement of gametes, fertilized eggs, or aquatic animals?

A. Compliance with inspections and monitoring procedures. Service personnel may not transfer or release gametes, fertilized eggs, or aquatic animals from Service-managed facilities until all pathogen inspection and monitoring procedures have been completed as recommended in the accompanying handbook. Service personnel should not move animals until they receive notification that all laboratory assays have been completed and animals are cleared for movement by the FHP supervisor.

B. Compliance with regulations and policy. Service personnel may only transfer or release gametes, fertilized eggs, or aquatic animals in compliance with inter-jurisdictional, Federal, State, Tribal, and foreign aquatic animal health regulations and guidelines and this policy.

2.8 What situations require quarantine and isolation of gametes, fertilized eggs, or aquatic animals?

A. Quarantine is required when:

(1) Gametes, fertilized eggs, and aquatic animals from free ranging (wild) stocks are brought into a facility, except anadromous fish returning to the hatchery of origin.

(2) The FHP supervisor determines that the pathogen screening or disease history for a source is inadequate.

B. The FHP supervisor predetermines and establishes the criteria for the aquatic animals to be transferred out of the quarantine or isolation facility.

C. At the discretion of the FHP supervisor, quarantine or isolation facilities located within a larger facility can be considered separate facilities if:

(1) There is no direct or indirect contact with other aquatic animals on the larger facility, and

(2) Strict biosecurity measures are in place. Consult the handbook for specific information regarding quarantine and isolation procedures.

2.9 What additional restrictions pertain to aquatic animal health-related activities at Service primary broodstock facilities?

A. The goal of primary broodstock facilities, relative to the health of aquatic animals, is to maintain their status as Listed Pathogens Not Detected (LPND).

B. Additional requirements are placed on primary broodstock facilities to further minimize possibilities for spreading significant pathogens into facilities, stocks, and geographic areas not known to harbor such pathogens. As these primary broodstock facilities supply many National Fish Hatchery System facilities and programs, and in many cases, non-Federal hatcheries, it is imperative that the health status for these broodstock facilities are maintained as LPND.

(1) Sampling. Broodstock of the same species consisting of more than one year-class held in a common water supply may be considered as one lot for sampling purposes; however, the Service recommends sampling of each year-class. To facilitate the collection of appropriate samples, the inspecting aquatic animal health professional should coordinate broodstock inspections with the spawning season.

(2) Pathogen screening. Service personnel must screen primary broodstock facilities for the pathogens identified in the facility’s inspection plan, which must be developed in accordance with chapter 2 of the handbook. At a minimum, primary broodstock facilities must be screened for Infectious Hematopoietic Necrosis virus (IHNv), Viral Hemorrhagic Septicemia virus (VHSv), Infectious Pancreatic Necrosis virus (IPNv), and Renibacterium salmoninarum.

C. FHP leadership must evaluate deviation from this policy on a case-by-case basis, and the Regional Director must approve it.

2.10 What specific requirements pertain to the water hardening and disinfection of eggs?

A. All salmonid eggs must be disinfected with a polyvinyl pyrolidone iodine compound during the water-hardening process (see the handbook for more information). Salmonid eggs received at Service-managed facilities from outside sources must be disinfected before they are permitted to come into contact with water used for aquatic animal culture purposes, rearing units, or equipment at the receiving station (see the handbook for more information).

B. Eggs of other species should be disinfected when an appropriate method is available:

(1) During the water-hardening process; or

(2) When eggs are received at Service-managed facilities from outside sources before they are permitted to come into contact with water used for aquatic animal culture purposes, rearing units, or equipment at the receiving station.

2.11 What specific actions are required when a significant pathogen is detected? If Service personnel detect and confirm a significant pathogen at a Service-managed facility, the following requirements must be met:

A. The FHP supervisor must immediately notify the Assistant Regional Director for Fish and Aquatic Conservation, who in turn must immediately notify the Regional Director, the Chief of the Branch of Hatchery Operations and Applied Science, and the facility manager.

B. All shipments to and from the affected facility must be suspended immediately.

C. The FHP supervisor or designee must notify potentially affected Federal, State, and Tribal partners.

D. The FHP supervisor must implement this policy and the relevant sections of the handbook.

2.12 What must be on the Inspection Report?

A. The Inspection Report must include any pathogen detected and confirmed during inspection, monitoring, or diagnostics that is listed on the Facility Inspection Plan, or that is an emerging or exotic pathogen deemed significant.

B.  Service personnel must record detections as follows: bacterial pathogens as genus and species, parasites and fungi as genus and species if known, viral pathogens as the common name.

C. If no pathogens meeting the criteria in section 2.12A are detected during the inspection period, the lot(s) are designated as LPND.

D. A 5-year facility pathogen history must be maintained on the Inspection Report.

E. Service personnel must also report the information in section 2.12A to the appropriate Federal, State, and Tribal authorities.