R58-17-15. Aquatic Animal Health Approval

  (A) Live aquatic animals, except ornamental fish and marine aquatic animals as provided in R58-17-4(2), unless the ornamental fish are determined a risk pursuant to R58-17-2(A)(24), may be acquired, purchased, sold or transferred only from sources which have been granted health approval by the Department pursuant to this section. This applies to separate facilities owned by the same individual and to both in-state and out-of-state facilities.

  (1) The Department shall be responsible for granting health approval and assigning a health approval number to aquaculture facilities in Utah, and to any out-of-state sources pursuant to 4-37-501(1). The Division shall be responsible for granting health approval and assigning a health approval number to public aquaculture facilities within the state, and for the movement of live aquatic animals from wild populations in waters of the state pursuant to 4-37-501(1).

  (2) The Department is responsible for granting health approval for the importation into or transportation through Utah of aquatic animals.

  (3) The Board may review health approval actions of the Department or the Division.

  (B) Basis for Health Approval:

  (1) Health approval for salmonid aquatic animals is based on the statistical attribute sampling of each lot of aquatic animals at the facility in accordance with current Blue Book procedures. This shall require minimum sampling at the 95% confidence level, assuming a 5% carrier prevalence for the prohibited pathogens, pursuant to R58-17-15(D)(2) and (3). Health approval is applied to the entire facility, not individual lots of aquatic animal.

  (2) All lots of aquatic animals shall be sampled.

  (3) For brood facilities, lethal sampling may be required on

  the brood aquatic animals if the following conditions exist:

  (a) Progeny are not available at the facility for lethal sampling;or

  (b) A statistically valid sample of ovarian fluids from ripe females is not tested.

  (4) Collection, transportation and laboratory testing of the samples will follow standard procedures specified by the Department, the Division and the Board. Inspections will be conducted under the direction of an individual certified by the American Fisheries Society as a fish health inspector.

  (5) EGG ONLY sources - A facility which cannot gain full health approval because of a horizontally transmitted pathogen, may be approved to sell eggs provided the eggs are free of the listed vertically transmitted pathogens pursuant to R58-17-15(D)(1) and are properly disinfected using approved methods prior to shipment. Eggs may be required to be from incubation units isolated from hatchery and open water supplies and to be from aquatic animal-free water sources.

  (6) Health approval for non-salmonid aquatic animals is based on specific pathogen testing for that identified aquatic animal as per R58-17-15(D). This shall require minimum sampling at the 95% confidence level, assuming a 5% carrier prevalence for the prohibited pathogens, pursuant to R58-17-15(D)(2) and (3). In addition, the agency having responsibility pursuant to R58-17-15(A)(1) and (2) will discuss the disease history of the facility with the producer, and then contact acceptable fish health professionals to identify other existing or potential disease problems.

  (a) An exemption for a statistical attribute sampling of each lot of fish may be granted for non-salmonid species that reside in the same water source throughout their life history and are of equal pathogen susceptibility. In which case, a representative composite sample of 60 fish.

  (7) Under no circumstances shall health approval be granted to a facility if any lots test positive for pathogens listed in R58-17-15(D)(2) or (3) or if any of the same pathogens contaminate the facility's production waters or water source.

  (C) Approval Procedures:

  (1) Applicable to all aquatic animals.

  (a) To receive initial health approval, inspection reports or other evidence of the disease status of an aquaculture facility or public aquaculture facility must be submitted to the appropriate agency (see R58-17-15(A)(1) and (2)). Applicants seeking initial approval and annual renewal for non-salmonid aquatic animals shall complete and submit forms provided by the Department or Division. Initial approval also requires the applicant to include information on origins of the aquatic animals at the facility, available disease histories by means of a facility disease history report and a five year disease history report, and aquatic animal transfer histories. The same application materials shall be required annually for renewal of health approval for activities occurring between applications.

  (b) Inspections are conducted pursuant to Utah Code Section 4-37-502 and this rule to detect the presence of any prohibited pathogens listed under R58-17-15(D)(2) and (3). Overt disease need not be evident to disqualify a facility. To qualify for initial and renewal of health approval, evidence must be available verifying that prohibited pathogens listed under R58-17-15(D)(2) and (3) are not present.

  (c) Once requirements for health approval have been met, the facility shall be added to the health approval list of the responsible agency and assigned a health approval number for the current year. Health approval of each facility shall be reviewed annually for continuance on the lists maintained by the Department and the Division pursuant to R58-17-15(A)(1).

  (d) The Department will report all confirmed results of pathogens pursuant to R58-17-15(D) for sources under its jurisdiction at each meeting of the Board.

  (e) Public aquaculture facilities and wild brood stocks are included on the health approval list maintained by the Division. The Division will report all confirmed results of pathogens pursuant to R58-17-15(D) for sources under its jurisdiction at each meeting of the Board.

  (f) If all aquatic animals are removed from an approved facility for a period of three months or more, or if health approval is canceled or denied, then subsequent health approval may be granted only after the facility owner has satisfactorily reapplied pursuant to R58-17-15(C).

  (2) Applicable to salmonid aquatic animals:

  (a) For initial approval of new facilities, two inspections of the same lot, at least four months apart and negative for any prohibited pathogen listed in R58-17-15(D)(2) and (3), are required. The aquatic animals must have been at the facility at least six months prior to the first inspection. During the inspections, the aquatic animals shall be reared for appropriate periods in waters from one source, and lots from all source waters at a facility shall be inspected.

  (b) For initial approval of existing facilities, health inspection reports for a minimum of the previous two years, and facility disease history reports for up to the previous five years and five-year disease histories for all stocks transferred to the facility are required.

  (c) All lots of aquatic animals at the facility as well as any outside sources of these aquatic animals must be inspected for initial approval and for renewals pursuant to R58-17-15(B)(4).

  (d) After initial approval, annual inspections shall be conducted to renew health approval. A two-month grace period is granted at the completion of the annual inspection for laboratory testing of samples and reporting of test results. This is to allow the facility to conduct business while awaiting test results. Health inspection reports, the facility disease history for at least the previous year, and disease histories for at least the previous year for all stocks imported to the facility shall be required before each renewal.

  (3) Applicable to non-salmonid aquatic animals:

  (a) For approval of facilities, one inspection of aquatic animals to be approved from the pond, reservoir, or holding facility and negative testing of an appropriate attribute sample for any applicable prohibited pathogen pursuant to R58-17-15(D)(2) and (3)is required. A composite sample of 60 aquatic animals of the same lot from all ponds in the shipment from the same water source may be accepted in lieu of a full attribute sample.

  (b) In addition, a written report is required from an acceptable fish health professional stating that no clinical signs of any infectious aquatic animal disease are ongoing and that certain pathogens are not infecting the species to be imported at the time of importation.

  (D) Prohibited and reportable pathogen list:

  (1) Pathogens requiring control are classified as emergency prohibited, prohibited, or reportable. Those pathogens denoted by an asterisk (*) preceding the name will only be tested for if the aquatic animals or eggs originate from an area where the pathogen is found. Pathogens denoted by a double asterisk (**) after the name can only be transmitted in aquatic animals and not in the eggs, therefore permitting the special provisions for egg only sources provided in R58-17-2(A)(10) and R58-17-15(B)(5). Excluding Artemia cysts, aquatic shrimp and prawns are not marketed as eggs, thus exempting shrimp and prawns from the egg-only provisions. However, the egg-only provision may be applied should shrimp or prawns be marketed as eggs and the Department or Division determines a vertically transmissible, emergency prohibited pathogen is present. Pathogens of aquatic shrimp and prawns are denoted with a triple asterisk (***) after the name. Pathogens that are inspected using the most current OIE Manual of Diagnostic Tests for Aquatic Animals are denoted with the pound sign (#) after the name.

  (2) Emergency prohibited pathogens.

  (a) Infectious hematopoietic necrosis virus (IHNV).

  (b) Infectious pancreatic necrosis virus (IPNV).

  (c) Viral hemorrhagic septicemia virus (VHSV).

  (d) *Oncorhynchus masou virus (OMV).

  (e) Spring viremia of carp virus (SVCV).

  (f) *Epizootic hematopoietic necrosis virus (EHNV)#.

  (g) White spot syndrome virus (WSSV)***#.

  (h) Yellow head virus (YHV)***#.

  (i) Taura syndrome virus (TSV)***#.

  (j) Infectious hypodermal and hematopoietic necrosis virus (IHHNV)***#.

  (3) Prohibited pathogens.

  (a) Myxobolus cerebralis (whirling disease)**.

  (b) Renibacterium salmoninarum (bacterial kidney disease (BKD)).

  (c) *Ceratomyxa shasta (ceratomyxosis disease)**.

  (d) Bothriocephalus (Asian tapeworm disease bothriocephalosis)**.

  (e) *Tetracapsuloides bryosalmonae or PKX (proliferative kidney disease (PKD))**.

  (f) Emerging aquatic animal pathogens the State Veterinarian considers a threat to state aquatic resources, including any filterable agent or agent of clinical significance as determined by the Board.

  (4) Reportable pathogens.

  (a) Yersinia ruckeri (enteric redmouth disease)**.

  (b) Aeromonas salmonicida (furunculosis disease)**.

  (c) Centrocestus formosanus**.

  (d) Any emerging aquatic animal pathogens the State Veterinarian considers a threat to the state aquatic resources including any filterable agent or agent of clinical significance as determined by the Board.

  (5) The Procedures for the Timely Reporting of Pathogens shall be followed if any emergency prohibited, prohibited, or reportable pathogen is found. Inspection for reportable pathogens is optional, but positive findings of these pathogens must be reported to the Board. Reporting of unregulated pathogens to the Board is not required.

  (6) The Emergency Response Procedures shall be activated any time a confirmed finding or unconfirmed evidence of an emergency prohibited or prohibited pathogen is reported.