1. The Operational Challenge of Effective Biosecurity Programs (“Winning the battle without losing the war”) John R. MacMillan, Ph.D. President, National Aquaculture Association, and W. Richard Smith, Jr. Partner, Robinson & Cole LLP

2. Biosecurity Objectives Protect farm stock Protect farm stock Protect human health & environment Protect human health & environment Promote public confidence & sustainable production Promote public confidence & sustainable production

3. Changing Need for Biosecurity Increasing interstate & international product movement Increasing interstate & international product movement Increased movement of live fish or round fish for processing Increased movement of live fish or round fish for processing Time critical shipment & availability demands Time critical shipment & availability demands

4. Commercial Facility Biosecurity Program Requirements Operationally compatible security measures Operationally compatible security measures Economically sustainable security measures Economically sustainable security measures Security measures commensurate with risk Security measures commensurate with risk Intergovernmental coordination Intergovernmental coordination Facility-adaptable approaches available Facility-adaptable approaches available Results-driven, not rules-driven Results-driven, not rules-driven Maximization of effectiveness vs. absolutism Maximization of effectiveness vs. absolutism Readily available and reliable diagnostics Readily available and reliable diagnostics Customer, vendor, employee and public acceptance Customer, vendor, employee and public acceptance

5. Biosecurity Program Drivers Facility and operational factors Facility and operational factors Regulatory factors Regulatory factors Market factors Market factors

6. Facility and Operational Factors Farm designs control biosecurity options Farm designs control biosecurity options –(pens, ponds, flow through, recirculation) Species-specific management reqts. Species-specific management reqts. –(breeding, development, growth, food, environment, etc.) Biological unknowns Biological unknowns –(sources, pathways, life cycles, controls)

7. Facility and Operational Factors, cont. New vs. old facility management measures New vs. old facility management measures –Ability to retrofit, existing site limitation Water source, treatment, control options Water source, treatment, control options Ability to modify biosecurity measures, adapt system and incorporate new technology and scientific information Ability to modify biosecurity measures, adapt system and incorporate new technology and scientific information

8. Regulatory factors Proscriptive regulation challenges Proscriptive regulation challenges –Addressing facility variables –Rulemaking hurdles (cost, effectiveness) –Ensuring rulemaking addresses realities Limited ability to modify rules Limited ability to modify rules

9. Regulatory Factors, cont. Science-based controls and restrictions Science-based controls and restrictions –Stock distribution limitations –Operating standards –Product quality Enforcement Enforcement –Standards are enforced by penalties –More-detailed plans are harder to maintain –Violations of regulations and private actions

10. Market Factors Product cost impacts Product cost impacts –Manpower, training, process, time Competitor differentials Competitor differentials –Effects of jurisdictional variations Impacts on stock or product availability Impacts on stock or product availability Impacts on production volumes Impacts on production volumes –Density, management

11. Market Factors, cont. “Acceptance” issues “Acceptance” issues –Employees (personal protection, hygiene, chemical training) –Public (chemical use, facility safety) –Vendor (monitoring, reporting and quality responsibilities) –Customer (product availability and quality impacts)