Food Safety Modernization Act (FSMA) Key Themes/Concepts

1. Food Safety Modernization Act (FSMA) Key Themes/Concepts Jeannie Perron, JD, DVM Covington & Burling LLP

2. Food Safety Modernization Act (FSMA) Key Themes/Concepts • Focus on prevention, not inspection/ testing • Risk-based approach

3. Food Safety Modernization Act (FSMA) Key Themes/Concepts • Supply chain traceability/ transparency • Know your supplier, particularly for imports

4. Food Safety Modernization Act (FSMA) Key Themes/Concepts • Enable food safety crises rapid response, containment • Enhance FDA’s inspection/ enforcement authority

5. Hazard Analysis • Must identify/evaluate known or reasonably foreseeable hazards: • biological, chemical, physical, radiological hazards; natural toxins; pesticide and drug residues; unapproved food/color additives; allergens • hazards naturally occurring or intentionally introduced

6. Hazard Analysis • Reanalyze every 3 years or whenever a significant change is made affecting risk

7. Preventive Controls • Identify and implement preventive controls • to significantly minimize or prevent identified hazards and • so undeclared allergens will not adulterate or misbrand food

8. Preventive Controls • Must monitor and verify that preventive controls are effective, and take corrective action when needed • Verification activities include environmental and product testing programs • Must keep records of these activities for 2 years, including test results

9. Preventive Controls • Preventive controls are: • Risk-based procedures, practices, and processes • That a knowledgeable person would employ • Consistent with current scientific understanding of safe food manufacturing/ handling

10. Preventive Controls • Examples include: • Sanitation procedures and practices • Process pathogen controls • Allergen control program • Recall plan • Current good manufacturing practices (cGMPs) • Verification procedures for suppliers and incoming ingredients

11. Preventive Controls – FDA Regulatory Implementation • Hazard analysis/preventive controls requirements effective July 2012 • Statute says FDA must promulgate regulations by then that • establish science-based minimum standards for: • analyzing and documenting hazards • implementing and documenting preventive controls • work for all sizes and types of facilities

12. Preventive Controls – FDA Regulatory Implementation • FDA may exempt from hazard analysis/preventive control requirements facilities solely engaged in the storage of packaged foods that are not exposed to the environment

13. Traceability • By Jan. 2013, FDA must require additional recordkeeping for “high risk” foods

14. Foreign Supplier Verification Program • U.S. importers must have a program by January 2013 to verify that imported food is produced in accordance with U.S. requirements

15. Foreign Supplier Verification Program • FDA must promulgate guidance and regulations within 1 year, and may require: • monitoring records for shipments • lot-by-lot certification of compliance • annual on-site inspections • checking the hazard analysis and preventative controls of the foreign supplier, and • periodically testing and sampling shipments

16. Expanded FDA Records Access • FDA records access authority expanded to foods FDA believes “likely to be affected in a similar manner” • FDA will have access to all newly-required records (including test results)

17. Facility Registration Changes • Biennial registration • No registration fee • Bill does contain fees for reinspection and reimbursement of FDA’s recall-related expenses

18. Facility Registration Changes • Suspension of registration • If FDA determines that a food manufactured, processed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death, may suspend • If suspended, food from facility may not be introduced into commerce

19. FDA Inspection/Enforcement • Increased inspection schedule • Hi-risk facilities • Once during first 5 years after enactment • Every 3 years thereafter • Other facilities • Once during first 7 years after enactment • Every 5 years thereafter

20. FDA Inspection/Enforcement • FDA mandatory recall authority for Class I recalls • Relaxed standards for administrative • detention • “reason to believe” food is adulterated or misbranded