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Acheson FSMA Tracing Webinar 01-07-11


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Acheson FSMA Tracing Webinar 01-07-11

  1. 1. Food Tracing: Implications of the Food Safety Modernization Act<br />David W K Acheson M.D.<br />1<br />
  2. 2. What are the challenges<br />What are the drivers for new requirements <br />What is required in the legislation<br />What do regulators want<br /> How to stay ahead of new requirements<br />2<br />Outline<br />
  3. 3. 3<br />The Supply Chain<br />Trace Forward<br />Trace Back<br />
  4. 4. Challenges<br />The complexity<br />Distribution systems – broad and fast <br />Supply chain unknowns<br />Suppliers - suppliers<br />Brokers sources<br />Inconsistent record keeping<br />Extent of records<br />Electronic v paper<br />Changing names of products<br />Different systems of tracking<br />Repacking of products<br />
  5. 5. Not finding the source fast enough <br />Reduce exposure<br />Determine the cause<br />Not determining the scope soon enough<br />Difficult to provide targeted consumer advice<br />Too many secondary recalls<br />Struggle with one up and one back<br />Gaps at the start (farms) and end (consumers)<br />5<br />Why do the regulators care?<br />
  6. 6. Inability for regulators to determine where food is moving in the supply chain<br />Salmonella Saintpaul 2008<br />Peanut products 2009<br />Melamine in Wheat gluten 2007<br />Not able to narrow the scope quickly<br />Consumer exposure continues<br />Industry “damage” remains broad<br />Industry unhappy about breadth of message<br />6<br />Drivers for Change<br />
  7. 7. A portion of the trace back diagram<br />
  8. 8. Pilot Programs:<br />Within 9 months, FDA must develop pilots with the processed food sector and produce industry<br />Demonstrate how track and trace would work for small businesses<br />Demonstrate technologies to inform promulgation of regulations<br />Within 18 months, FDA must provide a report to Congress on recommendations for establishing more effective product tracing, including consideration of: <br />Costs and benefits<br />Feasibility of technologies for different sectors<br />Existing practices and international efforts<br />8<br />What does the new law require?<br />
  9. 9. Establishment of a product tracing system<br />Prior notice of rule making within 2 years to establish recordkeeping requirements for high-risk foods<br />Requirements for Regulation:<br />Relate only to information that is reasonably available<br />Consider cost and public health benefit<br />Be scale-appropriate and similar across commodities<br />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<br />9<br />What does the new law require?<br />
  10. 10. FDA to define high-risk products within 1 year based on: <br />Known safety risks of a particular food;<br />Likelihood of microbiological or chemical contamination;<br />Point in manufacturing process where contamination is likely to occur and steps taken to reduce the possibility of contamination;<br />Likelihood consuming the food will result in foodborne illness; and<br />Likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food<br />10<br />What does the new law require?<br />
  11. 11. Exemptions for Farms<br />High-risk food produced and packed on a farm will not be subject to new recordkeeping requirements if: <br />The package maintains the integrity of the product and prevents subsequent contamination, and<br />The food is labeled with the name, complete address, and business phone number of the farm<br />FDA can request that farms identify immediate recipients, other than consumers, during an active investigation or when deemed necessary to protect public health<br />11<br />What does the new law require?<br />
  12. 12. Requirements for Farm Sales to Consumers and Grocery Stores<br />Farms will not have to keep any distribution records for food sold directly to a consumer or grocery store<br />Grocery stores will be required to maintain records showing the farm that was a source of food for up to 180 days <br />Commingled Raw Agricultural Commodities<br />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<br />12<br />What does the new law require?<br />
  13. 13. Consistency<br />Speed<br />Full supply chain coverage<br />Electronic records<br />Interoperable systems<br />Can be multiple so long as they “talk to each other”<br />Coverage of imports and domestic<br />Industry to develop the tools<br />Industry to pay for it<br />13<br />What do the Regulators Want?<br />
  14. 14. Start with higher risk foods<br />Focus on speed and interoperability <br />Develop systems that can clear brands, products or food categories<br />Early query of the system when multiple possible sources<br />During outbreaks to exclude sections of the supply chain<br />Avoid “rolling recalls”<br />Systems that directly inform consumers<br />14<br />How to be an industry leader<br />
  15. 15. FDA will need partners<br />Possible model for tomato tracking – 2008<br />FDA needs to fully understand the challenges and limitations<br />Technological concepts – not specifics.<br />15<br />Opportunities<br />
  16. 16. Conclusions<br />Requirements for product tracking will change<br />Opportunities to provide input to FDA<br />New regulations will likely emerge<br />Regulators and Congress will not accept the status quo<br />Product tracking should be viewed as a food safety tool<br />Tracking systems need work<br />Determine the ROI<br />Develop cost effective tools<br />Engage with the regulators <br />
  17. 17. Thank You<br />David Acheson MD<br /><br />801-910-5795<br /><br />