A.
Scope and Intent
The transfer and/or introduction of organisms fall within
the jurisdiction of the Department of Marine Resources (
12 M.R.S.A.,
§6071) into coastal waters within the
State of Maine and the Department of Inland Fisheries and Wildlife (
12 M.R.S.A.,
§§7011,
7035
and
7201,
7202
) into public and/or private waters within the State of Maine. These rules are
intended to protect wild and farmed salmonid fish populations and shall be
applicable to all individuals involved in the culture and movement of live
salmonids and gametes.
B.
Prohibited Activity
(1) It is
unlawful to transfer live salmonid gametes or fish to any fish culture facility
in Maine or stock salmonid fish or gametes into the waters of Maine that do not
meet the requirements of these rules.
(2) No clinically diseased salmonid fish
shall be introduced into the waters of Maine.
C.
Definitions
For the purposes of these rules the following terms have the
following meanings:
(1)
Active
Surveillance
"Active surveillance" means laboratory testing which is
conducted during the annual hatchery inspection and during spawning as outlined
in Chapter 2.03-A (F).
(2)
Blue Book
"Blue Book" means Thoesen, J.C. 1994. Suggested procedures
for the detection and identification of certain finfish and shellfish
pathogens, 4th edition. Bluebook Fish Health Section American Fisheries
Society.
(3)
Broodstock
"Broodstock" means sexually mature fish (Size group
4).
(4)
Clinical
"Clinical" means any visual signs of disease by gross
external examination.
(5)
Confidence level
"Confidence level" means the probability of detecting
evidence of at least one infected fish within the population of fish tested at
the respective prevalence levels of the agent.
(6)
Diseases of Regulatory
Concern
"Diseases of Regulatory Concern" mean infectious agents that
have been demonstrated to cause a significant increase in the risk of mortality
among salmonid populations in the State of Maine. Diseases of Regulatory
Concern are classified by the Commissioner into three (3) disease categories
exotic, endemic (limited distribution) and endemic based on an annual review
and analysis of epidemiological data. See the following definitions and Chapter
2.03-A (E).
(a)
Exotic
"Exotic" means those infectious agents that have not been
detected in Maine as of the effective date of this rule. Pathogens classified
as exotic based on available current information include:
(i) VHSV: Viral Hemorrhagic Septicemia
Virus
(ii) IHNV: Infectious
Hematopoietic Necrosis Virus
(iii)
OMV: Oncorhynchus masou Virus
(iv)
CS: Ceratomyxosis (Ceratomyxa shasta)
(v) PKD: Proliferative Kidney Disease
(PKX)
(vi) WD: Whirling Disease
(Myxobolus cerebralis)
(vii) IsaV:
Infectious Salmon Anemia Virus
(viii) Other: Any pathogen not detected in
Maine as of the effective date of these rules.
(b)
Endemic (limited
distribution)
"Endemic (limited distribution)" means those infectious
agents of special concern whose geographic distribution within the State of
Maine is not fully known. Pathogens classed as endemic (limited distribution)
based on available information include:
(i) IPNV: Infectious Pancreatic Necrosis
Virus
(ii) BKD: Bacterial Kidney
Disease (Renibacterium salmoninarum)
(iii) BF: Furunculosis (Aeromonas
salmonicida)
(iv) BR: Enteric
Redmouth (Yersinia ruckeri)
(c)
Endemic
"Endemic" means those infectious agents currently recognized
to occur with predictable regularity in the State of Maine with only minor
fluctuation in frequency over time.
(7)
Fish Culture Facility
"Fish culture facility" means an establishment where
salmonids are grown for sale or release into inland waters of the State of
Maine.
(8)
Infectious
agents and abbreviations
The name of each infectious pathogen and its accepted
abbreviation are:
IPNV Infectious Pancreatic Necrosis Virus
IHNV Infectious Hematopoietic Necrosis Virus
VHSV Viral Hemorrhagic Septicemia Virus
OMV Oncorhynchus masou Virus
BF Furunculosis (Aeromonas salmonicida)
BR Enteric Redmouth (Yersinia ruckeri)
BKD Bacterial Kidney Disease (Renibacterium
salmoninarum)
WD Whirling Disease (Myxobolus cerebralis)
CS Ceratomyxosis (Ceratomyxa shasta)
PKD Proliferative Kidney Disease (PKX)
IsaV Infectious Salmon Anemia virus
Other Any pathogen not detected in Maine as of the effective
date of these rules.
(9)
Inspection
"Inspection" means an on-site, statistically-based sampling
of all lots of fish on the facility and resulting laboratory tests and
inspection reports conducted by an inspector in accordance with the testing
requirements and procedures set forth in these rules.
(10)
Inspector
"Inspector" means an accredited, licensed veterinarian, a
certified fish health inspector or persons recognized by federal or state
agencies with responsibility for fish health or transfer in the state from
which the fish or gametes originate upon approval of the Commissioner. No owner
or employee with direct supervisory authority over a facility may serve as an
inspector for their fish culture facility.
(a) "Accredited licensed veterinarian" means
a veterinarian holding a current veterinary license who has also fulfilled the
accreditation requirements of United States Department of Agriculture Animal
and Plant Health Inspection Service (USDA/APHIS).
(b) "Certified fish health inspector" means
an individual certified by the American Fisheries Society/Fish Health Section
(AFS/FHS) as a Fish Health Inspector or Fish Pathologist.
(11)
Lot
"Lot" means the following:
(a) A lot for size groups 1, 2, and 3
(non-brood facilities) is defined as fish of the same species and age that
originated from the same spawning stock and share a common water
supply.
(b) A lot for size group 4
is defined as fish of the same species that originated from the same spawning
stock and share a common water supply, but several age groups (e.g., 3, 4, and
5 year old brood fish) may be combined to form a representative composite lot
for sampling.
(12)
Marine Fish Health Zones
(Reserved for use by Department of Marine Resources.)
(13)
New England Salmonid
Health Guidelines
"New England Salmonid Health Guidelines" mean the January
15, 1997 edition of the New England Salmonid Health Guidelines.
(14)
Owner
"Owner" means any person, partnership, company or
corporation with a proprietary interest in the fish culture facility being
inspected.
(15)
Passive Surveillance
"Passive surveillance" means the collection of disease data
from historical records or diagnostic sampling done during a disease outbreak
or a disease investigation.
(16)
Prevalence
"Prevalence" means the number of detectable cases of disease
(or disease agents) present in a population.
(17)
Production Stock
"Production stock" means salmonid fish of size groups 1, 2,
and 3.
(18)
Size
Group
"Size Group" means:
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 brood
stock.
Size Group 4: Sexually mature fish used as brood
stock.
(19)
Qualified
Source/Hatchery
"Qualified source/hatchery" means an established
source/hatchery that has had 3 consecutive annual inspections in which
pathogens as described in Chapter 2.03-A (E) have not been detected; or a new
hatchery that has had 3 successive negative annual inspections over a
continuous 2 year period.
(20)
Quarantine
"Quarantine" means:
No movement of live fish off or to the site;
No visitors to site except necessary fish health
personnel;
A biosecurity program approved by the Commissioner must be
instituted at the site; and
Disposition of deceased and quarantined fish must be
approved by the Commissioner.
(21)
Reproductive Fluids
"Reproductive fluids" means testicular and ovarian
fluids.
(22)
Restriction
"Restriction" means:
No movement of live fish off or to the site;
Disinfection protocols and biosecurity must be instituted at
the site.
(23)
Salmonid Fish
"Salmonid Fish" means fish of the family Salmonidae.
(24)
Spawning
Broodstock
"Spawning broodstock" means a lot of sexually mature
salmonid fish whose gametes will be incubated at fish culture facilities within
Maine.
(25)
Transfer
Permits and Reports(A)
Annual
Fish Health Inspection Report
"Annual Fish Health Inspection Report" means the letter from
the Inspector acknowledging that all lots of fish have been inspected according
to procedures outlined in Chapter 2.03-A (F). The Fish Health inspection report
shall include an itemized account of results.
(B)
Fish Health Inspection
Report
"Fish Health Inspection Report" means a letter from the
Inspector acknowledging that a specific lot or lots of fish have been inspected
according to procedures outlined in Chapter 2.03-A (F). The Fish Health
inspection report shall include an itemized account of results.
(C)
Annual Fish Culture
Facility Health Report
"Annual Fish Culture Facility Health Report" means a letter
from the Commissioner stating the health status of any Fish Culture Facility
that requires an annual Fish Health Inspection Report. The Fish Culture
Facility Health Report shall be based upon the findings of Annual Fish Health
Inspection Reports, the guidelines provided in Annex V of the New England
salmonid Health Guidelines and any other fish health inspection reports.
(D)
Importation
Permit
"Importation Permit" means the permit issued by the
Commissioner that authorizes the recipient to import salmonids to designated
geographical area(s) in the inland waters of Maine during a specified time
period.
(E)
Pond
Stocking Permit
"Pond Stocking Permit" means the permit issued by the
Commissioner that authorizes the recipient to transfer and/or release live
salmonids into inland waters of Maine.
D.
Compliance Reporting Requirements,
Reporting and Permits
(1)
(a) Any person wishing to import, possess, or
sell live salmonids or gametes for the purposes of stocking into inland waters
of maine shall provide a fish health inspection report stating that such
salmonid fish or gametes have been inspected for all diseases of regulatory
concern before a permit to engage in such activity is issued.
(b) Live salmonid fish or gametes taken from
the wild shall be subject to isolation as defined in Annex V and Annex VI of
the New England salmonid Health Guidelines pending the completion of inspection
procedures outlined in Chapter 2.03-A (F) and the issuance of a fish health
inspection report.
(2)
Any salmonid fish facility raising fish to be introduced into the inland waters
of Maine must submit the most current annual fish health inspection report on
approved forms to the Department of Inland Fisheries & Wildlife prior to
the sale and/or movement of such fish from the facility.
(3) Any person applying for a permit to
import live salmonids or gametes into the State of Maine shall demonstrate that
the fish or gametes being imported are free from evidence of all diseases of
regulatory concern, from a source which meets or exceeds the standards
established in these rules and that the source and facility have been free from
evidence of all diseases of regulatory concern for three years immediately
preceding the permit application or a new hatchery that has had 3 successive
negative annual inspections over a continuous 2 year period. The Commissioner
may prescribe additional fish health testing requirements for importation of
salmonids or gametes into the State of Maine. A copy of the current approved
importation permit shall accompany the fish or gametes during
transfer.
(4) Any person offering
live salmonids or gametes for sale or transferring live salmonids or gametes to
a source in Maine shall provide a current fish health inspection report to any
customer or recipient of the fish. A copy of the current approved importation
or stocking permit shall accompany the fish or gametes during
transfer.
(5) Live salmonid fish or
gametes transferred for purposes of immediate harvest for human consumption,
diagnostic inspection or related laboratory research shall not be subject to
the provisions of these rules. Salmonids harvested for the purposes of human
consumption shall be harvested, handled, processed and transported using
measures to minimize the introduction of infectious disease into Maine waters.
The Fish Health Technical Committee will serve as a technical resource in
developing guidelines for biosecurity measures associated with harvesting,
transport and processing.
E.
Testing requirements for Diseases of
Regulatory Concern
|
Spawning Broodstock
|
Production Stock
|
|
Size Group 4
|
Size Group 1
|
Size Groups 2 & 3
|
|
Inspection Testing Requirement
|
Exotic Reportable
|
Endemic, limited distribution Reportable
|
Exotic Reportable
|
Endemic, limited distribution Reportable
|
Exotic Reportable
|
Endemic, limited distribution Reportable
|
|
Active Surveillance
|
VHSV
IHNV
ISAV
|
IPNV
BKD
|
VHSV
IHNV
|
IPNV
|
VHSV
IHNV
WD
ISAV
|
BF
BR
IPNV
BKD
|
|
Passive Surveillance
|
OMV
CS
WD PKD
Other
|
BF
BR
Other
|
OMV
CS
PKD
Other
|
BF
BR
BKD
|
OMV
CS
PKD
Other
|
F.
Inspection Procedure: The following procedures shall be carried
out by an inspector, as defined in these regulations.
(1) A fish culture facility inspection of all
production lots shall be completed at least annually.
(2) Fish health inspections shall be
conducted at a time or times of the year conducive for the detection of
pathogens with regard to the age and size of fish and environmental
conditions.
(3) A visual exam of
all tanks/raceways to assess general health status shall be conducted during
the annual inspection.
(4) Testing
procedures for infectious agents shall be conducted according to requirements
and methodologies approved by the Commissioner. Testing requirements for
salmonids in the respective size groups shall be conducted according to Chapter
2.03-A (E). For viral pathogens, the inspector shall test at the 95% confidence
level, 5% prevalence per lot. For bacterial pathogens, the inspector shall test
at 95% confidence level, 10% prevalence per lot. In order to detect evidence of
the agent of Whirling Disease, the inspector shall sample sixty fish per
facility or per water supply, if the facility has more than one water supply.
Samples examined for evidence of Whirling Disease shall be of the most
susceptible species and ages of fish available. For example, select brook or
rainbow trout over brown trout or coho salmon. Select fish at least 5 months
old if possible, as referenced in the Blue Book under Parasitology, Section VI,
Whirling Disease, part F, procedures for detecting subclinical infections. If
bacterial pathogens are negative for 3 consecutive annual inspections, then
sampling levels may drop to 20% prevalence for as long as sampling continues to
test negative.
(5) Spawning
Broodstock shall be tested within 30 days immediately before or after spawning
for diseases of regulatory concern according to Chapter 2.03-A (E).
(a) 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 chain of custody protocol in accordance with Chapter 2.03-A
(F)(4).
(b) Complete laboratory
diagnostic testing (virology, bacteriology and parasitology) done on broodstock
mortalities during a given year can be included if the lethal sampling option
is chosen.
(6)
Sample size
(a) 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 depending upon conditions
outlined 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 | 150 | 60 | 30
| 15 |
| and any larger |
The above sample sizes are the minimum number of fish to be
tested and in situations where pathogens are suspected, larger 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.
(b) 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.
(c) Pathogens as described in Chapter 2.03-A
(E) detected by passive surveillance between annual fish health inspections
must be reported by the owner of the fish culture facility to the Commissioner
at the time of inspection.
(d) Upon
completion of the annual inspection of the fish culture facility, an inspection
report will be issued to the owner/operator and the Commissioner. Uponreceipt
of the inspection report, the Department will review the report and may issue a
permit if the report meets the standards outlined in these rules.
(e) Lots of fish and/or gametes received from
qualified sources/hatcheries will not invalidate that fish culture facility's
annual inspection status.
(f) Lots
of fish and/or gametes received from sources other than qualified
sources/hatcheries that do not comply with Chapter 2.03-A (D)(1) will
invalidate the receiving fish culture facility's annual inspection
status.
G.
Fish Health Technical Committee
A Fish Health Technical Committee shall be established
jointly by the Commissioners of the Departments of Inland Fisheries and
Wildlife and the Department of Marine Resources to provide advice to maintain
optimum health among Maine's aquatic resources and to safeguard wild and
cultured organisms from the introduction of infectious organisms.
(1)
Composition and Selection
The composition and selection of the Fish Health Technical
Committee shall reflect the interdisciplinary expertise required to address
aquatic animal health issues. All members of the Fish Health Technical
Committee shall be qualified fish health inspectors or qualified professionals
in the fish health field.
(a) There
shall be three members representing the public resource agencies Department of
Inland Fisheries and Wildlife, Department of Marine Resources and Department of
Agriculture, Food and Rural Resources.
(b) There shall be one member representing
the United States Fish and Wildlife Service.
(c) There shall be one member representing
the National Marine Fisheries Service.
(d) There shall be one member representing
the U.S. Department of Agriculture, Animal Plant Inspection Service.
(e) There shall be two members at large of
which at least one shall be from academia.
(f) There shall be two members with
experience in commercial finfish culture.
(g) The chair person shall be elected by a
majority vote of the Fish Health Technical Committee.
(2)
Responsibilities
(a) Responsibilities of the Fish Health
Technical Committee shall be to provide technical advice to the Commissioners
in the following areas:
(i) Procedures for
disease surveillance and health monitoring among salmonid resources.
(ii) Diagnostic protocols and
standards.
(iii) Criteria for
biosecurity, quarantine, animal destruction and facility clean up.
(iv) Control of a disease outbreak.
(v) Following annual review and analysis of
epidemiological data provide recommendations to the Commissioners regarding the
classification and testing requirements for Diseases of Regulatory
Concern.
(b) The Fish
Health Technical Committee shall also:
(i)
Annually review and make recommendations on disease surveillance and the health
status of salmonid resources.
(ii)
Actively pursue the development of research programs for addressing the
salmonid health issues facing the State's resources.
(iii) Serve as a technical resource for fish
facility managers to improve management and husbandry practices.
(iv) Develop recommendations for rules to
address inspection requirements for non-salmonid fish species.
H.
Consequences/Action Plan
(1)
Exotic Diseases(a) When any
exotic disease of regulatory concern is confirmed at any salmonid fish culture
facility in Maine as a result of active or passive surveillance, the owner of
the facility shall notify the Commissioner in writing and by telephone within
24 hours of the confirmation. In addition, within 24 hours all fish on the site
must be immediately restricted. The report to the Commissioner must include, as
a minimum:
(i) Species of fish
affected;
(ii) Size group and age
of fish;
(iii) Pathogen and whether
it is clinical or non clinical;
(iv) Prevalence;
(v) Actions being taken to contain or
eradicate the pathogen; and
(vi)
Proposed actions to restore the facility to a qualified
source/hatchery.
(b) The
Commissioner shall review the relevant facts and may consult with the Fish
Health Technical Committee, relevant State and federal agencies, other
professionals, and make a decision concerning the restricted fish.
Consideration will be given to certain risk factors including but not limited
to:
(i) Risk to the aquaculture
industry;
(ii) Risk to wild
stocks;
(iii) Feasibility of
eradication by stock destruction;
(iv) Time frame and degree of pathogen spread
i.e., local vs. regional;
(v) Final
intended disposition of infected stocks; and
(vi) Public health
ramifications.
(c)
Following completion of risk assessment, the Commissioner may order one or more
of the following remedial actions.
(i) Harvest
and sale of processed fish;
(ii)
Destruction of the stock and proper disposal to minimize release of
pathogen(s);
(iii) Stocking of the
fish if such action possesses no or minimal risk to wild populations;
(iv) Re-test stock for pathogen;
(v) Treatment of fish and re-test;
(vi) Quarantine and continued quarantine of
fish for purpose of study or salvage of gametes; or
(vii) Other actions determined to be
appropriate by the Commissioner upon consultation with the Fish Health
Technical committee.
(2)
Endemic Diseases (Limited
Distribution)(a) When any Endemic
Disease (Limited Distribution) of regulatory concern is confirmed at any
salmonid fish culture facility in Maine as a result of active or passive
surveillance, the owner of the facility shall notify the Commissioner within 14
days after confirmation of the disease and prior to movement or transfer. The
report to the Commissioner must include, as a minimum:
(i) Species of fish affected;
(ii) Size group and age of fish;
(iii) Pathogen and whether it is clinical or
non clinical;
(iv)
Prevalence;
(v) Actions being taken
to contain or eradicate the pathogen; and
(vi) Proposed actions to restore the facility
to a qualified source/hatchery.
(b) The Commissioner shall review the report,
Annex IV of the New England Salmonid Health Guidelines and may consult with the
Fish Health Technical Committee, relevant State and Federal agencies, other
professionals, and make a decision concerning movement or transfer of the
fish.
(3)
Endemic
Diseases
(a) When any Endemic Disease
of regulatory concern is confirmed at any salmonid fish culture facility in
Maine as a result of active or passive surveillance, the owner of the facility
shall notify the Commissioner 14 days prior to movement or transfer. The report
to the Commissioner must include, as a minimum:
(i) Species of fish affected;
(ii) Size group and age of fish;
(iii) Pathogen and whether it is clinical or
non clinical;
(iv)
Prevalence;
(v) Actions being taken
to contain or eradicate the pathogen; and
(vi) Proposed actions to restore the facility
to a qualified source/hatchery.
