FDA’s Proposed Rule under FSMA for Preventive Controls Key Takeaways May 17, 2013

Highlights from Major Provisions What foreign governments need to know Agenda Introduction 10 Key Takeaways Highlights from Major Provisions What foreign governments need to know Question and Answer Session

Introduction FDA has proposed two new regulations under FSMA Preventive Controls for human food Food Defense to come later Produce Safety Comments due September 17, 2013 FDA says that more proposed rules are forthcoming

Overview of Preventive Controls Proposal Adds a new set of regulations implementing the Hazard Analysis and Risk-Based Preventive Controls provision of FSMA Updates and revises the cGMPs in 21 CFR Part 110 Includes several exemptions and modified requirements Includes a subpart on recordkeeping Would place everything in a new 212 CFR Part 117 CFR= 美国联邦法规??

10 Key Takeaways

1. Proposed rule generally tracks the statute Registered facilities must have a food safety plan： Hazard Analysis Preventive Controls Monitoring Corrective Actions Verification Reanalysis Recordkeeping Make records available to FDA Limited exemptions

2. FDA has tried to align proposal with HACCP Preamble traces origins of HACCP Repeated references to other government HACCP programs Many references to Codex Use of HACCP Principles and Terminology HACCP Hazard “reasonably likely to occur” Use of parameters (like “critical limits”) Preventive controls may be at critical control points

3. Supplier Verification Not Required (Yet) Although expressly identified as a preventive control, FDA has not proposed to mandate supplier verification and approval activities, likely due to cost But the proposed rule contains extensive discussion of the value of such programs, key attributes, and FDA’s expectations for such programs FDA seeks comment on whether to impose requirements in these areas and extent of any final requirements (Read preamble and Appendix) –Important to Comment – Likely to be in Final Rule Impact on the Foreign Supplier Verification Program

4. Testing not required (yet) Although expressly mentioned in the statute, testing is not being required as a verification activity, likely due to cost But the proposed rule contains extensive discussion of the value of such programs, key attributes, and FDA’s expectations for such programs FDA seeks comment on whether to impose requirements in these areas and extent of any final requirements (Read preamble and Appendix Carefully) Important to Comment – Likely to be in Final Rule

5. Emphasis on Validation and Corrective Actions FDA expects high level of scientific justification for the plan Would include collecting and evaluating scientific and technical information Food allergen controls, sanitation controls, and the recall plan would not need to be validated FDA expects written corrective action procedures Corrective actions would need to be documented and subject to verification and records review

6. Warehouse exemption Exempt: Facilities solely engaged in the storage of: Non-refrigerated packaged food not exposed to the environment Raw agricultural commodities (other than fruits or vegetables) intended for further distribution or processing Modified Requirements: Facilities that store refrigerated packaged food that requires time/temperature control for safety (TCS)

7. High emphasis on recordkeeping/FDA access New record creation requirements Specific requirements for the content of those records Keep records on-site at least 6 months Always keep food safety plan on-site Make records available promptly Facility profiles Remote access Electronic records

8. Updates to cGMPs Outgrowth of cGMP Modernization Initiative In general, FDA proposes: Clarifying that certain provisions require protection against cross contact of food in order to address allergens That provisions directed to preventing contamination of food and food contact surfaces include preventing contamination of food packaging materials as well Many other changes throughout For example: requiring companies store and transport all food (not just finished food) under conditions to protect against cross-contact, cross contamination, as well as deterioration of food and the container

9. Small and very small businesses： Small – less than 500 employees across the entire company Very small – either $250,000, $500,000, or $1,000,000 in annual sales of food Extended time for compliance for both Very small businesses subject to modified requirements Small and very small businesses performing certain low-risk on-farm activities would be exempt Need to check where these definitions came from….

10. Compliance dates 1 year for large businesses 2 years for small businesses 3 years for very small businesses ** All from date of publication of Final regulation

A few words on: The Produce Safety Proposed Rule Rather than issue standards for categories of produce considered high-risk, the proposed rule would apply to almost all produce The requirements focus on agricultural practices (not commodities), except: Specific commodities rarely consumed raw (e.g., potatoes) Produce subject to a kill step through commercial processing, so long as documentation kept (e.g., oranges for juice) Produce that is not a raw agricultural commodity (and therefore is subject to Preventive Controls)

Produce Safety Proposed Rule (continued…) Would set standards to control for 6 specific hazards: Worker Training and Health and Hygiene Agricultural Water Biological Soil Amendments Domesticated and Wild Animals Equipment, Tools, and Buildings Sprouts

What Foreign Governments Need to Know : Foreign food companies exporting food to the U.S. will be subject to the very SAME requirements as U.S. companies. Therefore, foreign food companies shipping food to the U.S. need to: Become educated on FDA’s proposed requirements Start getting ready as basic framework will likely remain Inform others in the food industry in your country Get involved in the rulemaking process by submitting written comments (in English) by September 16, 2013

This is an Ongoing Process . . . This is just a proposal, it hasn’t been finalized and may be modified Compliance will be enforced starting at least one year from when the rules are finalized (not from now) There are more rules coming, particularly the Foreign Supplier Verification Program rule

Questions?