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 2

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

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

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 5

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

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 7

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 8

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 9

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 10

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 11

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 12

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

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 14

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 15

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) 16

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

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 18

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 19

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 20