09-137 C.M.R. ch. 2, § 03-A - Salmonid Fish Health Inspection Regulations

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.

Notes

09-137 C.M.R. ch. 2, § 03-A