The Food Safety Modernization Act establishes new requirements for tracing foods through the supply chain. It will require recordkeeping for high-risk foods and the ability to trace foods one step forward and one step back. This poses challenges due to the complexity of distribution systems and suppliers. Regulators want faster and more consistent tracing to help narrow the scope of foodborne illness outbreaks. The new law requires the FDA to define high-risk foods and establish tracing requirements within two years, with some exemptions for small farms. It also establishes pilots to demonstrate tracing technologies and costs. Industry should view tracing as a food safety tool and work with regulators to develop effective and cost-efficient tracing systems.

1. Food Tracing: Implications of the Food Safety Modernization Act David W K Acheson M.D. 1

2. What are the challenges What are the drivers for new requirements What is required in the legislation What do regulators want How to stay ahead of new requirements 2 Outline

3. 3 The Supply Chain Trace Forward Trace Back

4. Challenges The complexity Distribution systems – broad and fast Supply chain unknowns Suppliers - suppliers Brokers sources Inconsistent record keeping Extent of records Electronic v paper Changing names of products Different systems of tracking Repacking of products

5. Not finding the source fast enough Reduce exposure Determine the cause Not determining the scope soon enough Difficult to provide targeted consumer advice Too many secondary recalls Struggle with one up and one back Gaps at the start (farms) and end (consumers) 5 Why do the regulators care?

6. Inability for regulators to determine where food is moving in the supply chain Salmonella Saintpaul 2008 Peanut products 2009 Melamine in Wheat gluten 2007 Not able to narrow the scope quickly Consumer exposure continues Industry “damage” remains broad Industry unhappy about breadth of message 6 Drivers for Change

7. A portion of the trace back diagram

8. Pilot Programs: Within 9 months, FDA must develop pilots with the processed food sector and produce industry Demonstrate how track and trace would work for small businesses Demonstrate technologies to inform promulgation of regulations Within 18 months, FDA must provide a report to Congress on recommendations for establishing more effective product tracing, including consideration of: Costs and benefits Feasibility of technologies for different sectors Existing practices and international efforts 8 What does the new law require?

9. Establishment of a product tracing system Prior notice of rule making within 2 years to establish recordkeeping requirements for high-risk foods Requirements for Regulation: Relate only to information that is reasonably available Consider cost and public health benefit Be scale-appropriate and similar across commodities Should not prescribe specific technologies, require a full pedigree, require a record of recipient of food beyond the immediate subsequent recipient, or product tracking to the case level 9 What does the new law require?

10. FDA to define high-risk products within 1 year based on: Known safety risks of a particular food; Likelihood of microbiological or chemical contamination; Point in manufacturing process where contamination is likely to occur and steps taken to reduce the possibility of contamination; Likelihood consuming the food will result in foodborne illness; and Likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food 10 What does the new law require?

11. Exemptions for Farms High-risk food produced and packed on a farm will not be subject to new recordkeeping requirements if: The package maintains the integrity of the product and prevents subsequent contamination, and The food is labeled with the name, complete address, and business phone number of the farm FDA can request that farms identify immediate recipients, other than consumers, during an active investigation or when deemed necessary to protect public health 11 What does the new law require?

12. Requirements for Farm Sales to Consumers and Grocery Stores Farms will not have to keep any distribution records for food sold directly to a consumer or grocery store Grocery stores will be required to maintain records showing the farm that was a source of food for up to 180 days Commingled Raw Agricultural Commodities Recordkeeping requirements for commingled raw agricultural commodities will be limited to maintaining records that identify the immediate pervious source of such food and the immediate subsequent recipient of such food 12 What does the new law require?

13. Consistency Speed Full supply chain coverage Electronic records Interoperable systems Can be multiple so long as they “talk to each other” Coverage of imports and domestic Industry to develop the tools Industry to pay for it 13 What do the Regulators Want?

14. Start with higher risk foods Focus on speed and interoperability Develop systems that can clear brands, products or food categories Early query of the system when multiple possible sources During outbreaks to exclude sections of the supply chain Avoid “rolling recalls” Systems that directly inform consumers 14 How to be an industry leader

15. FDA will need partners Possible model for tomato tracking – 2008 FDA needs to fully understand the challenges and limitations Technological concepts – not specifics. 15 Opportunities

16. Conclusions Requirements for product tracking will change Opportunities to provide input to FDA New regulations will likely emerge Regulators and Congress will not accept the status quo Product tracking should be viewed as a food safety tool Tracking systems need work Determine the ROI Develop cost effective tools Engage with the regulators

17. Thank You David Acheson MD david@leavittpartners.com 801-910-5795 www.leavittpartners.com