Section 188-24-34 - Pleuronectids (fish in the family Pleuronectidae)1.DefinitionsFor the purposes of these rules the following terms have the following meanings:
A. "Size Groups" means: "Size Group 1": Larval period and juvenile size range of <= 4 cm in length.
"Size Group 2": Juvenile >= 4 cm in length and yearlings.
"Size Group 3": Production fish greater than one year old.
"Size Group 4": Mature fish or fish set aside to be used as broodstock upon maturity.
2.Pathogen list for PleuronectidsA. Exotic pathogens include: IHNV Infectious Hematopoietic Necrosis Virus
VHSV Viral Hemorrhagic Septicemia Virus
IsaV-DEL Infectious Salmon Anemia virus (HPR-deleted variants)
GID Francisella species - granulomatous inflammatory disease
La02[BETA] Listonella (Vibrio) anguillarum serotype 02 beta
OTHER Any agent not detected in Maine as of the effective date of these rules that produces a cytopathic effect in cell culture during inspection.
B. Endemic/Limited Distribution pathogens include: IPNV Infectious Pancreatic Necrosis Virus
ISAV-HPR0 Infectious Salmon Anemia Virus (non-deleted variants)
BF Furunculosis (Aeromonas salmonicida) typical and atypical
Nodavirus: VERV (viral encepathalopathy and retinopathy) or also referred to as VNNV (viral nervous necrosis virus)
Loma Loma branchialis (syn. L. morhua.)
OTHER Any agent that produces a cytopathic effect in cell culture during inspection.
3.Testing Requirements for Pathogens of Regulatory Concern | Marine Site and Hatchery-based Broodstock | Wild Caught Broodstock | Production Stock |
| Size Group 4 | Size Group 4 | Size Group 1 | Size Groups 2 & 3 |
Inspection Testing Requirement | Exotic | Endemic/Limited Distribution | Exotic | Endemic/Limited Distribution | Exotic | Endemic/Limited Distribution | Exotic | Endemic/Limited Distribution |
Active Surveillance | VHSV IHNV ISAV-DEL La02[BETA] Other | BF IPNV Nodavirus Loma General Parasitology Histology for general baseline | Biosecurity audits quarterly | | VHSV IHNV ISAV-DEL | IPNV Nodavirus Other | VHSV IHNV ISAV-DEL La02[BETA] Other | BF IPNV Nodavirus Loma General Parasitology Histology for general baseline |
Passive Surveillance | GID Other | ISAV-HPR0 Other | VHSV IHNV ISAV-DEL La02[BETA] Other GID | Nodavirus IPNV ISAV-HPR0 BF Loma Other | La02[BETA] GID Other | BF ISAV-HPR0 Loma Other | GID Other | ISAV-HPR0 Other |
4.Inspection Procedure: The following procedures shall be carried out by an inspector, as defined in these regulations. A.Qualified source/hatchery inspection: Except for approved quarantine facilities, those facilities which intend to serve as a qualified source/hatchery for import or transfer to other fish culture facilities or that stock fish into the coastal waters of the State shall complete an inspection of each production lot at least annually. Lot inspections may occur at different times of the year, as long as all lots are tested at least once every twelve months. Inspection of a lot should occur within 4 months prior to a proposed transfer date. When a lot of fish which has only had partial pathogen screening due to small size at the time of testing is to be moved from the premises, and the fish have attained a sufficient size to allow testing for a complete range of pathogens, then additional testing to complete an overall pathogen screening of a production lot before transfer should be completed.
B. Fish health inspections shall be conducted at a time or times of the year conducive for the detection of pathogens and with regard to the age and size of fish and environmental conditions.C. A visual exam of all tanks/raceways to assess general health status shall be conducted during the annual inspection.D. Testing procedures for infectious agents shall be conducted according to requirements and methodologies approved by the Commissioner. Testing requirements for Pleuronectids in the respective size groups shall be conducted according to Chapter 24.34(3). For viral and bacterial pathogens, the inspector shall test at the 95% confidence level, 5% prevalence per lot by isolation procedures. For Nodavirus, a viral agent, the inspector shall additionally test 10% of lethally sampled larvae or fish via RT-PCR. For Loma, general parasitology, and baseline histology, the inspector shall test at the 95% confidence, 20% assumed prevalence level per lot.E. Spawning Broodstock shall be tested within 30 days immediately before or after spawning for diseases of regulatory concern according to Chapter 24.34(3). (1) Reproductive fluids shall be sampled at the 100% level or lethal sampling at the 10% prevalence up to a maximum of 30 fish and reproductive fluids at the 2% prevalence level. Reproductive fluids can be collected by trained facility personnel under the direction of the inspector using a specimen chain of custody form.(2) If neither the lethal sampling option nor reproductive fluid sampling options are appropriate for a facility with limited, valuable broodstock, then to eliminate lethal sampling of brood, the facility must:(a) Maintain the broodstock in a physically separated or isolated room or building from production lots with restricted entry and a documented biosecurity plan in place.(b) Individually identify brood fish by means of a permanent tag or other marking device.(c) For wild-caught broodstock, sample progeny as part of routine facility inspections. Results of this testing as well as the testing of a representative sample at the time of initial movement, as descried in Chapter 24.30(3)(A)(2), will be applied toward the broodstock health history.(d) For hatchery-based broodstock, lethal sampling to continue testing history should come from other fish from the same lot not being used for broodstock.(e) For marine net-pen facility cultured broodstock, lethal sampling at the time the fish are introduced to a land based facility is required, including all testing as outlined for size group 2, and will include additional bacterial testing to include screening for Francisella species. Fish must be held in an approved quarantine facility for the first 6 weeks after introduction to the facility, and any mortalities must be tested as described for marine site broodstock above.(3) Complete laboratory diagnostic testing (virology, bacteriology and parasitology) done on broodstock mortalities during a given year should be included for either lethal or non-lethal sampling options. (F)Sample size: (1) For viral and bacterial pathogens the number of samples to be collected from a given lot shall be based upon stratified random sampling which provides 95 percent confidence of detecting a pathogen with an assumed minimum prevalence of detectable infection of two to twenty percent as follows: Minimum sample sizes for populations varying from 50 to infinity are as follows:
Assumed Prevalence: | 2% | 5% | 10% | 20% |
| | | | |
Population or lot size | Size | of | Sample | |
50 | 50 | 35 | 20 | 5 |
100 | 75 | 45 | 23 | 8 |
250 | 110 | 50 | 25 | 11 |
500 | 130 | 55 | 26 | 13 |
1,000 | 140 | 55 | 27 | 14 |
1,500 | 140 | 55 | 27 | 14 |
2,000 | 145 | 60 | 27 | 15 |
10,000 | 145 | 60 | 27 | 15 |
100,000 and any larger | 150 | 60 | 30 | 15 |
The above sample sizes are the minimum number of fish to be tested and in situations where pathogens are suspected, additional samples shall be taken at the discretion of the fish health inspector. The method of collecting sub samples from rearing units to obtain a representative sample is left to the discretion of the inspector.
(2) Inspections shall be performed and samples collected by the inspector or a person working under his/her supervision. The inspector is responsible for all work performed.(3) Pathogens as described in Chapter 24.34(3) detected by passive surveillance between annual fish health inspections must be reported by the marine fish culture facility owner to the Commissioner at the time of inspection.(4) Upon completion of the annual inspection of the fish culture facility, an inspection report will be issued to the marine fish culture facility owner or operator and the Commissioner. Uponreceipt of the inspection report, the Department will review the report and may issue a transfer permit if the report meets the standards outlined in these rules.(5) Lots of finfish transferred from qualified sources/hatcheries to a receiving facility will not invalidate the receiving fish culture facility's annual inspection status.(6) Lots of finfish received from sources other than qualified sources/hatcheries that do not comply with Chapter 24.30(3)(A) will invalidate the receiving fish culture facility's annual inspection status.13-188 C.M.R. ch. 24, § 34