1. January 2011 1 Food Safety Modernization Act: Overview and Impact

3. Most sweeping overhaul of the food safety system since 1938

4. Several provisions are already in effect

5. Increased inspection frequency

6. Expanded records access

7. Import certification authority

8. Mandatory recall authority

9. Fees

10. Port shopping

12. 4 Mandatory Inspection Frequencies What will be different? FDA will not be able to meet requirements with current resources Utilize Federal, State, and Local regulatory partners (domestic facilities) Utilize third party certification (foreign facilities) Agreements with foreign governments Deny import of food from firms refusing inspection What does this mean Greater regulatory presence Increased oversight of and focus on imported food

14. Relating to that article of food

17. 8 Mandatory Recall Authority What is new? Gives FDA authority to require a mandatory recall of product if responsible party refuses to voluntarily recall If FDA orders mandatory recall, informal hearing with the responsible party due within 2 days Failure to comply subject to civil penalties and criminal prosecution Incident Command Operation for each recall to coordinate government activities Who is impacted? Registered facilities that manufacture, process, pack, or hold food Farms, restaurants, and retail food establishments that are exempt from registering under Section 415 of the Food, Drug, and Cosmetic Act will not be directly impacted, but may be involved in recalls

18. 9 Mandatory Recall Authority What will be different Previously, if a firm refused to recall, FDA could issue press and pursue a court order, in each applicable jurisdiction, to seize the product Gives FDA authority to take action without prior court approval What does this mean? Majority of recalls occur voluntary and quickly because firms to not want to risk making consumers sick Fills a gap in FDA authority Probably will not be used on a routine basis

20. Certificates can apply to a specific shipment of food or to a facility

21. Requirement for certification is based on:

22. Known safety risks associated with the food

23. Know safety risk of the country, territory, or region of origin

26. How FDA defines risk will be important

28. Re-inspection of a facility (including importers)

29. Cover all FDA recall related costs

30. Participate in Voluntary Qualified Importer Program

31. Port Shopping

32. Requires notification by FDA to the Secretary of Homeland Security when food is refused admission to prevent importers from port shopping

33. Whistleblower protections

35. Preventive controls

36. Protection against intentional adulteration

37. Performance standards

38. Standards for fresh produce

39. Accreditation of third party auditors

40. Accreditation of laboratories

41. Traceability

42. Foreign supplier verification program

44. Sooner of 180 days or FDA issuing regulation

45. FDA can suspend registration if food presents a reasonable probability of causing serious adverse health consequences

46. Preventive Controls Requirement

47. Identify hazards

48. Implement preventive controls

49. Monitor, correct, and verify

50. Document

51. Foreign supplier verification

52. Food was produced in compliance with preventive controls and produce standards

54. FDA to pilot product tracing in processed food and produce sectors

55. Implement a product tracing system

56. Additional record-keeping requirements for high-risk foods

57. Protection against intentional contamination

58. FDA to issue guidance on mitigation strategies

59. FDA to issue regulations on who is required to implement mitigation strategies

60. New dietary ingredients

61. FDA guidance on definition of new dietary ingredient

62. Evidence needed to document the safety of new dietary ingredients

64. Importers must verify that imported food is produced in compliance with U.S. laws and regulations

65. Voluntary qualified importer program

66. Expedited review of food offered by importers participating in the program

67. Authority to require certification for imported food

69. Must notify FDA of any country that refused the product

70. Accreditation of third party auditors

71. Conduct audits of foreign facilities and issue certifications to ensure product is in compliance with U.S. laws and regulations

73. FDA to develop program within 2 years

75. Required plan for building capacity with foreign governments should include provisions for the multilateral acceptance of laboratory methods and testing and detection techniques

76. Performance Standards

78. Impact of much of the legislation is dependent on how regulations are drafted

79. Implementation is dependent of FDA resources

80. Provide input on rule-making process

81. Stay in front of changes

82. Understand and respond to dynamics