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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 Biosecurity Objectives • Protect farm stock • Protect human health & environment • Promote public confidence & sustainable production Changing Need for Biosecurity • Increasing interstate & international product movement • Increased movement of live fish or round fish for processing • Time critical shipment & availability demands Commercial Facility Biosecurity Program Requirements • • • • • • • • • Operationally compatible security measures Economically sustainable security measures Security measures commensurate with risk Intergovernmental coordination Facility-adaptable approaches available Results-driven, not rules-driven Maximization of effectiveness vs. absolutism Readily available and reliable diagnostics Customer, vendor, employee and public acceptance Biosecurity Program Drivers • Facility and operational factors • Regulatory factors • Market factors Facility and Operational Factors • Farm designs control biosecurity options – (pens, ponds, flow through, recirculation) • Species-specific management reqts. – (breeding, development, growth, food, environment, etc.) • Biological unknowns – (sources, pathways, life cycles, controls) Facility and Operational Factors, cont. • New vs. old facility management measures – Ability to retrofit, existing site limitation • Water source, treatment, control options • Ability to modify biosecurity measures, adapt system and incorporate new technology and scientific information Regulatory factors • Proscriptive regulation challenges – Addressing facility variables – Rulemaking hurdles (cost, effectiveness) – Ensuring rulemaking addresses realities • Limited ability to modify rules Regulatory Factors, cont. • Science-based controls and restrictions – Stock distribution limitations – Operating standards – Product quality • Enforcement – Standards are enforced by penalties – More-detailed plans are harder to maintain – Violations of regulations and private actions Market Factors • Product cost impacts – Manpower, training, process, time • Competitor differentials – Effects of jurisdictional variations • Impacts on stock or product availability • Impacts on production volumes – Density, management Market Factors, cont. • “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)