13-188-24 Me. Code R. § 21
The Commissioner may, at his discretion and in consultation with the AAHTC, issue a permit to import or transfer finfish from sources or facilities that do not meet the requirements of these rules to an approved quarantine facility. Transfer from an approved quarantine facility, or a change in operation to that which is less biosecure, may be permitted if post-import testing provides satisfactory evidence of freedom from those pathogens of regulatory concern for which evidence of freedom was not satisfied at the time of import.
For the purposes of these rules the following terms have the following meanings in addition to the definitions in Chapter 24.01 and 24.16(1):
Size Group 1: Fish less than or equal to 4 cm in length, commonly referred to as fry.
Size Group 2: Fish from 4 to 6 cm in length, commonly referred to as fingerlings.
Size Group 3: Non-brood fishes greater than 6 cm in length, commonly referred to as yearlings/adults, which are not being held as broodstock.
Size Group 4: Reproductively mature fish used as broodstock.
Evidence of disease freedom for Ceratonova/Ceratomyxa shasta (ceratomyxosis), Myxobolus cerebralis (Whirling disease), and Tetracapsuloides byrosalmonae (PKD) may be considered satisfactory for meeting the requirements of a qualified source/hatchery, if importation will be in the form of embryos that have been iodine disinfected before and immediately after import, prior to the time of introduction to the waters of the receiving facility.
Spawning Broodstock | Production Stock | |||||||
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 | ||
Active Surveillance | VHSV IHNV ISAV-DEL | IPNV BKD | VHSV IHNV ISAV-DEL | IPNV | VHSV IHNV WD ISAV-DEL | BF BR IPNV BKD | ||
Passive Surveillance | OMV CS WD PKD SPDV Other | BF BR ISAV-HPR0 Other | OMV CS PKD SPDV Other | BF BR BKD ISAV-HPR0 Other | OMV CS PKD SPDV Other | ISAV-HRP0 Other | ||
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 subsamples from rearing units to obtain a representative sample is left to the discretion of the inspector.
IHNV Infectious Hematopoietic Necrosis Virus VHSV Viral Hemorrhagic Septicemia Virus OMV Oncorhynchus masou Virus WD Whirling Disease (Myxobolus cerebralis)
CS Ceratomyxosis (Ceratomyxa shasta)
PKD Proliferative Kidney Disease (PKX unclassified myxozoan)
IsaV-DEL Infectious Salmon Anemia virus
SPDV Salmonid Pancreatic Disease Virus
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.
ISAV HPR0 Infectious Salmon Anemia Virus (non-deleted variants)
IPNV Infectious Pancreatic Necrosis Virus
BKD Bacterial Kidney Disease (Renibacterium salmoninarum)
BF Furunculosis (Aeromonas salmonicida)
BR Enteric Redmouth (Yersinia ruckeri)
OTHER Any agent that produces a cytopathic effect in cell culture during inspection.
All marine salmonid finfish net pen culture facilities (finfish facilities), located within the coastal waters of the State of Maine, are subject to the requirements of this subsection. These requirements are in addition to the other requirements of Chapter 24.21.
All holders of finfish aquaculture leases, or their designees, shall comply with these surveillance and reporting requirements. For those leaseholders that are participating in a United States Department of Agriculture (USDA) voluntary ISA control program, where conflicts exist between these rules and voluntary ISA control program standards or rules the USDA standards or rules shall govern.
Surveillance for Infectious Salmon Anemia Virus (ISAV) in accordance with this subsection (24.21(1)(G)) shall be conducted by inspectors designated by the Maine Department of Marine Resources. All analytical tests shall be completed within 14 days of the date of sampling and records made available to the Department upon request. All samples must have a clear written chain of custody from the inspector to the accredited analytical laboratory conducting the tests.
The level of surveillance shall be consistent with the most recent available version of the United States Department of Agriculture, Animal and Plant Health Inspection Service's "Infectious Salmon Anemia Program Standards" (ISA Standards). Sampling must be conducted monthly for all active salmonid facilities. The Commissioner may authorize an alternative sampling protocol where conditions warrant.
The Commissioner may require more frequent testing for specific finfish facilities if a suspected positive case of ISAV is detected.
Reverse transcriptase polymerase chain reaction (RT-PCR) shall be the primary screening diagnostic test utilized to detect the presence of ISAV. Indirect fluorescence antibody test (IFAT) impression smears will be acetone-fixed and archived. IFAT slides corresponding to any tissue sample testing positive by RT-PCR will subsequently be tested. Classification of samples with respect to ISAV detection shall conform to the ISA Standards. In the event of a positive ISAV diagnostic procedure, diagnostic tests to resolve the classification of suspect or unconfirmed samples using material from the positive tests or remaining sample material must be initiated within 24 hours of any positive diagnostic procedure. Viral culture is required using fish collected during a 7-day reinspection for suspect finfish facilities. Genetic sequencing may be warranted following RT-PCR positive findings. The Commissioner may require specific tests as necessary to resolve the classification of suspect or unconfirmed samples.
Surveillance results, regardless of whether ISAV was detected (positive or negative results), shall be reported in written form via email, fax or hand-delivery to the Department, within 24 hours of their completion. Each report shall include, at a minimum: Inspector's name, date sampled, DMR lease site identification code, pen(s) sampled, year class status of salmonids on the site, size group, name of the lab conducting each analysis, the analytical test(s) used, and copies of original laboratory test results.
All transfer permit requests (Chapter 24.16(1)(H)(4 and 5)) must include the most current ISAV status and a date of that status for the finfish facility to which the fish are to be transferred.
Marine to marine transfers are prohibited, unless an exemption is provided for on a case-by-case basis by the Commissioner. Exemptions shall only be granted for unusual circumstances that do not increase the likelihood of ISAV transmission between finfish facilities.
Participation shall be in the USDA ISA surveillance and monitoring program, unless the Commissioner reviews and approves a company ISA surveillance or indemnification program.
Following a confirmed positive case of ISAV, the Commissioner shall take action according to Chapter 24.16(5)(A) Exotic Diseases. This action plan shall include remedial action(s) including further diagnostic procedures. In the Commissioner's sole discretion, remedial action requirements may be based on the facility's existing ISAV action plan.
This subsection applies to all vessels, service equipment and net pens utilized to conduct finfish aquaculture operations and activities including, but not limited to harvest boats, well boats, personnel transport vessels, dive and mortality-handling vessels, and feed transport barges. It does not apply to recreational or commercial vessels not engaged in aquaculture.
All vessels, service equipment and net pens involved in aquaculture activities will be required to undergo an initial biosecurity audit by persons authorized by the Department when they are put into operation. Biosecurity audits, including timely follow-ups if needed to verify compliance with the initial audit's findings, shall be undertaken on a semi-annual basis in Marine Fish Health Zone, Area 1 and annually outside of Area 1. An initial audit must take place within 30 days of the first day of operation.
Authorized auditors have the authority to specify remedial action for deficiencies revealed in an initial audit. The Commissioner shall determine whether sufficient remedial action was taken by the marine net-pen facility owner after reviewing the initial and follow-up audit results.
All completed initial and follow-up audits shall be placed on file with the Department no later than 30 days following their completion. In order to be deemed acceptable, audits conducted in Canada must be signed by either the appropriate provincial authorities or an accredited veterinarian.
All vessels, service equipment, and net pens involved in aquaculture must be routinely disinfected according to the disinfection protocols established in the ISA Standards (most recent available edition).
Vessels, service equipment and net pens are prohibited from traveling west of the restricted area (Chapter 24.21(1)(H)(5)) unless exempted under Chapter 24.21(1) (H)(5)(a). Vessels, service equipment and net pens located outside the restricted area are prohibited from traveling into or through the restricted area unless exempted under Chapter 24.21(1)(H)(5)(a).
Vessels, service equipment and net pens are not prohibited from moving between the restricted area and Canadian waters, provided they do not travel west of the restricted area in order to do so.
However, there can be no movement of vessels, service equipment or net pens between either confirmed or suspected ISA or ISAv positive sites or bay management areas and Maine finfish aquaculture facilities without an authorization as described below.
All vessel operators shall maintain a log that clearly indicates all transit points of the vessel, including aquaculture site locations and bay management areas, disease status of the aquaculture site locations and bay management areas when known, and dates of all transit points. This log shall also include the date and manner of all disinfections conducted of the vessel.
At the Department's request, the log shall be submitted to the Department prior to entering the restricted zone defined below in Chapter 24.21(1)(H)(5) in order that the Department may verify the log information and the disease status of any of the sites or bay management areas with the appropriate authorities.
Pending review of the log, no vessel may enter the restricted zone as defined below in Chapter 24.21(1)(H)(5). After review of the log, vessels, service equipment, or net pens determined to have tended or visited any sites or bay management areas designated as being either confirmed or suspect for the presence of ISA or ISAv shall be subject to a required disinfection which may include below the waterline disinfection. For those vessels that have transited through a confirmed or suspect bay management area, the Department shall consider the specific routes and the present status of each site within the bay management area in determining the required disinfection.
Fish harvested as a result of an eradication order or from an aquaculture site designated as Category 2, 3, 4, or 5 as described in the United States Department of Agriculture's, Animal Plant Health Inspection Service's "Infectious Salmon Anemia Program Standards" (most recent available edition) or sites or bay management areas designated as confirmed or suspect by the Department for ISA or ISAV shall not be transported into or out of the restricted area by vessel unless authorized by the Department.
Such authorization shall require a risk evaluation be conducted by the Department and a complete disinfection and transit plan be approved by the Department prior to any transport of harvested fish.
Nets shall not be moved between finfish facilities. The movement of nets from finfish facilities to on-shore cleaning facilities is allowed provided the nets are contained.
These regulations apply to all vessels, service equipment and net pens utilized to conduct finfish aquaculture operations and activities located in Marine Fish Health Zone, Area 1 (Chapter 24.01(18)(A)).
Vessels, service equipment and net pens having undergone an initial and follow-up biosecurity audits maintained on a semi-annual basis, by a person authorized by the Commissioner, may be granted an exemption to the movement restrictions following approval by the Commissioner. Exemption requests must include biosecurity audit results, including any follow-up audit and be submitted by the vessel owner or operator to the Commissioner in writing, see contact information above under Chapter 24.21(1)(G)(2)(f). An exemption document must be available for inspection on an exempted vessel, service equipment and net pens at all times and displayed according to the Commissioner's instructions.
13-188 C.M.R. ch. 24, § 21