Appendix E
Shellfish High Health Program Guideline: A Voluntary Program for Producers of Live Shellfish

Reprinted with permission from Ralph Elston, Ph.D., of the Pacific Shellfish Institute


January 2004

Pacific Coast Shellfish Growers Association

120 State Avenue, N. E. #142

Olympia, Washington 98501-8212

Prepared by

Ralph Elston, PhD

Pacific Shellfish Institute

Olympia, Washington

Under grant NA86FD0262,

High Health Management of Pacific Oysters


from National Marine Fisheries Service

U.S. Department of Commerce

Saltonstall-Kennedy Program.


1.0 Purpose of the Shellfish High Health Program Guidelines


1.1 These Shellfish High Health program guidelines are provided for producers of live shellfish larvae, seed, brood stocks or other products that are exported and placed in receiving waters. Implementation of a Shellfish High Health program by an individual producer is voluntary. The purpose of implementing such a program for individual producer/exporters is to facilitate the process of obtaining import permits for live shellfish products from



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Appendix E Shellfish High Health Program Guideline: A Voluntary Program for Producers of Live Shellfish Reprinted with permission from Ralph Elston, Ph.D., of the Pacific Shellfish Institute January 2004 Pacific Coast Shellfish Growers Association 120 State Avenue, N. E. #142 Olympia, Washington 98501-8212 Prepared by Ralph Elston, PhD Pacific Shellfish Institute Olympia, Washington Under grant NA86FD0262, High Health Management of Pacific Oysters from National Marine Fisheries Service U.S. Department of Commerce Saltonstall-Kennedy Program. 1.0 Purpose of the Shellfish High Health Program Guidelines 1.1 These Shellfish High Health program guidelines are provided for produc- ers of live shellfish larvae, seed, brood stocks or other products that are exported and placed in receiving waters. Implementation of a Shellfish High Health program by an individual producer is voluntary. The purpose of imple- menting such a program for individual producer/exporters is to facilitate the process of obtaining import permits for live shellfish products from 

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0 APPENDIX E governments of importing countries or states and to reduce the risk of spreading infectious shellfish diseases. 1.2 We expect that the Pacific Coast Shellfish Growers Association (P.C.S.G.A.) Shellfish High Health Program guidelines to be endorsed by the Animal and Plant Health Inspection Service (A.P.H.I.S.) of the United States Department of Agriculture (U.S.D.A.). The U.S.D.A. is the federal agency responsible for negotiating the terms of bilateral trade agree - ments with trading partners of the United States in regard to live animal products. Under such agreements, the U.S.D.A. is recognized by foreign governments as the competent authority to provide assurance of health certification for U.S. export products. Such certification ensures that pro- ducers will have access to markets in countries or trading blocks that have established trade agreements with the United States. In addition, such certification should facilitate interstate transfer of live shellfish stocks to be placed in receiving waters. 1.3 The High Health Program is based upon regular surveillance of shellfish health, ongoing health documentation and the use of procedures that promote shellfish health. The framework High Health Program is designed to accomplish are the following: 1.3.1 Prevent the dissemination of certifiable infectious shellfish diseases with exported shellfish products. 1.3.2 Ensure free flow of healthy brood stocks, larvae and seed between health certified production facilities and participating coun- tries by meeting or exceeding shellfish health regulatory requirements for the exportation of live shellfish from producer locations to other states or countries. 1.3.3 Increase and maximize production efficiency by proactive health management. 1.4 The High Health Program guidelines will be reviewed periodi- cally by the Pacific Coast Shellfish Growers Association to ensure that the guidelines meet the Association’s goals for high health shellfish. 2.0 Components and Implementation of a Shellfish High Health Program 2.1 Participating producers. The Pacific Coast Shellfish Growers Association will maintain a list of voluntary participants in its Shellfish High Health program. It will be the responsibility of the individual pro- ducers to establish their own Shellfish High Health Program using these guidelines and to establish approval of their program and stocks by the U.S.D.A. 2.2 health certifications, records and documentation. Participating shellfish producers will maintain an ongoing historical record of the

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 APPENDIX E health of its shellfish, based on regular health examinations. These records will establish a documented disease free history which is the basis of qualifying as an exporter to many countries and states. 2.3 examination for certifiable shellfish diseases. Certifiable or reportable shellfish diseases are specified by state governments in the United States. In addition, recommendations may be provided by federal agencies and made by international advisory bodies such as the Organiza- tion Internationale Epizooties (OIE). The required frequency of shellfish health examinations is specified in some states in which members of the P.C.S.G.A. operate. In addition the sampling sensitivity (number of shellfish to need to be sampled and frequency of sampling to establish a disease free certification) may be similarly specified. The ability to export live shellfish to specific foreign countries may be dependent on meeting shellfish health certification requirements negotiated with that country or trading block by the competent authority (A.P.H.I.S. of the U.S.D.A.) of the United States. 2.4 Brood stock Management. A key objective of the Shellfish High Health program is the protection of brood stock holding areas to maintain their health status and to prevent the introduction of exotic infectious diseases to these areas. A brood stock health management program must have the following components. 2.4.1 Dedicated areas. Dedicated areas will be used for brood stock maintenance. Each cultured species of shellfish must be held in a defined and localized area clearly demarcated for brood stock and not used for other purposes. Dedicated areas will be selected to minimize any potential means of accidental introduction of infectious shellfish diseases. 2.4.2 Limited entry. Entry of any new cultured animal stocks to brood stock holding areas is very limited and managed very con- servatively. Any proposed shellfish introductions to the brood stock holding area or to a location close enough to the brood stock hold - ing area to present a risk of disease transfer into the holding area must have a disease free health history and undergo a certification evaluation, consistent with applicable regulatory requirements and company policy. 2.4.3 Ongoing health surveillance. A program of ongoing health characterization and evaluation is conducted for each brood stock holding area consisting of regular health certification of brood stock in these areas. 2.4.4 Health records. An historical log of health certification and surveillance records is maintained for each brood stock holding area.

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 APPENDIX E 3.0 Hatchery and Nursery Operations Protocols Hatchery and nursery production facilities producing exported shell - fish must be managed to exclude certifiable infectious diseases. A program of health management to accomplish this goal will include the following components. 3.1 Disease free water sources. Hatchery and nursery facilities and brood stock holding areas must be operated in or use waters free of cer- tifiable shellfish diseases. Sea water disinfection systems may be used to accomplish the goal of a disease free water source. 3.2 integrity of brood stocks in the hatchery. Brood stocks must be managed in the hatchery so they do not contact brood or offspring from any uncertified areas or from areas certified to a lower standard. Similar isolation requirements apply to larvae and seed offspring. 3.3 operations protocols. Facilities, at their option, may use health related protocols for the following operations, if needed to maintain free - dom from certifiable diseases, or otherwise enhance the health of shellfish stocks. 3.3.1 Management of primary and expanded algal stocks 3.3.2 Spawning management of brood stock 3.3.4 Larval rearing management 3.3.5 Setting management 3.3.6 Water quality maintenance 3.3.7 Disinfection and sanitation procedures 3.3.8 Infectious disease vector control 3.3.9 Carcass disposal 3.3.10 Employee training 3.3.11 Visitor access 3.4 hatchery records related to health management. Records are maintained that document any control point or operation required to exclude infectious diseases from hatchery stocks. 4.0 Response Plan for Infectious Disease Outbreaks The Shellfish High Health program is designed to exclude the intro- duction of certifiable infectious diseases to areas where shellfish for export are reared. Since infectious diseases can be introduced by natural means or other means outside of the control of a producer, the following response plan is in place in case of a significant infectious disease outbreak. This plan will be put in place if a certifiable disease is found or a new and significant infectious disease occurs with mortality not attributable to non-infectious causes exceeding a rate set by the pertinent regulatory authority. The response plan will consist of the following actions:

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 APPENDIX E 4.1 Confirmation of the infectious disease diagnosis. 4.2 Required notification of the responsible regulatory authorities of the disease outbreak. 4.3 Establishment of a disease containment area including contain- ment and/or disinfection procedures to prevent the movement of infected shell stock, equipment and contaminated materials out of the disease affected area. 4.4 Disinfection of contaminated culture water from any affected hatchery or nursery facilities. 4.5 Adequate disposal of dead shell to prevent dissemination of infec- tious disease organisms with such stock. 4.6 Destruction of infected stocks, if required to contain the disease, or if required by the regulatory authority. 4.7 Determination of the source of the infectious disease agent, in collaboration with appropriate regulatory agencies, and implementation of a plan to eliminate any continuing source of the disease agent introduc- tion, if needed. 4.8 Establishment of a monitoring and continuing response plan for the infectious disease and determination of needed continuing action, in conjunction with the appropriate regulatory agency.