FDA, THE PRIVATE LABORATORY AND ITS IMPACT ON TRADE

1. FDA, THE PRIVATE LABORATORY AND ITS IMPACT ON TRADE Presented by: Martin Mitchell Boston Seafood Show Date: March 16, 2009 Certified Laboratories, Inc. Full Service Laboratory – Est. 1926

2. CURRENT ISSUES • Lack of uniformity at Districts • Sampling Plans • Importer Statements • Use of electronic submission • Time Frames • Advance Scheduling

3. CURRENT ISSUES (Cont’d) • Lack of uniformity at FDA reviewing Labora tories • Acceptance of methodologies • Quality control paperwork • Validation requirements • Requirements within package • Analytical performance standards

5. ISO 17025 Accreditation Scope of work covers analysis submitted Established adequate sampling procedures and only Use of third party samplers Maintain files for 5 years Utilize AOAC Guidelines Sampling advance notice is required Laboratory Director affirmation Submit directly to FDA electronically CURRENT LABORATORY REQUIREMENTS

6. FUTURE OF LABORATORY ACCREDITATION Accreditation is the formal recognition by a third-party body that a laboratory is competent to perform specific tests (which are detailed in a scope of accreditation) in a reliable, credible and accurate manner.

7. ACCREDITATION ASSESSMENT TOOLS • Document reviews • Periodic on-site assessments • Ongoing proficiency testing • Feedback from laboratory customers

8. WHO BENEFITS FROM ACCREDITATION? • Regulators • Trade facilitators • General public • Industry • Accredited laboratories

9. FDA AND PRIVATE LABORATORIES • FDA - “Rigorous accreditation standards” give confidence that accredited laboratories are capable. • FDA can reallocate resources to audit labs. • Abbreviated laboratory will allow FDA to review more quickly. • FDA compliant products get fast track admissibility.