Introduction 1

The FDA Food Safety Modernization Act 2

FSMA Section 204: Enhancing Tracking and Tracing of Food and Recordkeeping 4

Pilot Projects and Data Gathering 4

Additional Recordkeeping Requirements for High-Risk Foods 5

Designation of High-Risk Foods 6

Exemptions, Limitations, and Waivers 7

Deadlines 7

FDA Implementation of FSMA Section 204 8

Report to Congress on Pilot Projects 8

FDA’s Food Traceability Rule 11

Food Traceability List 12

Subject Entities 15

Traceability Plan 15

Maintaining Records 15

Exemptions and Modified Requirements 17

FDA Product Tracing System 19

Delayed Compliance Date for FDA’s Food Traceability Rule 20

Issues for Congress 23

Inspector Training and Product Tracing System 23

Supporting Industry Compliance 24

Requirement Modifications and Exemptions 25

Rule Interpretation and Technical Assistance 26