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David W. Plunkett Collaborative Food Safety Forum Center for Public Reporting of Food Science in the Public Interest Import Metrics July 20, 2011 If you don't know where you are going, you might wind up someplace else. Yogi Berra


  1. David W. Plunkett Collaborative Food Safety Forum Center for Public Reporting of Food Science in the Public Interest Import Metrics July 20, 2011 “If you don't know where you are going, you might wind up someplace else.” Yogi Berra

  2. CSPI/SFI and IACFO  The Center for Science in the Public Interest (CSPI) is a bi-national NGO representing over 850,000 consumers in both the U.S. and Canada.  Safe Food International (SFI), a CSPI project, partners with consumer organizations in other regions of the world on food safety issues.  The International Association of Consumer Organizations provides representation in Codex for consumer organizations on five continents.

  3. The Importance of Metrics to Consumers  Reliable data and appropriate metrics are essential to measure performance for managing food safety programs and making continuous improvements to better protect the public from foodborne disease.  The keys to good metrics are:  Having good data,  Choosing the right things to measure, and  Transparent, consistent reporting.  For consumers, public reporting of data and metrics provides accountability and builds trust in the food safety system.

  4. What Will FDA Need under FSMA  FDA will need at least three specific data collections to implement import provisions under the FDA Food Safety Modernization Act.  Attribution data for the identification of high-risk foods.  International disease reporting for the identification of high- risk countries, territories and regions.  Inspection reports to establish the compliance histories for firms/facilities.  Import metrics under FSMA include –  Number of inspections performed  Accrediting bodies performance  Auditors performance

  5. Outbreak Data Resources Alert Safe Food Internat’l

  6. Attributio ion D Dat ata a in in Outbreak A Ale lert! • Outb tbre reak A k Alert! t! contains over 6,600 outbreaks between 1990-2008. • Using CDC’s Foodborne Out- break Online Database (FOOD), CSPI maintains a database of those foodborne illness outbreaks with an identified etiology and food vehicle. • Outbreaks in the CSPI database are placed within one of thirteen food categories. Each category is then subdivided into food types.

  7. Food od C Categor ories i s in Outbreak A k Alert! FDA DA-Reg egulated F ed Food USDA DA-Regulated F d Food  Beverages  Beef  Breads & Bakery  Pork  Dairy  Poultry  Eggs & Egg Dishes  Luncheon & Other Meats  Game  Multi-Ingredient Foods (No- Meat)  Both  Produce  Seafood

  8. Total and Solved Outbreaks 1998-2007 Colorado* % Solved Unidentified food and/or etiology Identified food and etiology Reported Outbreaks Solved CO Only, Solved 1,600 50 36% 45 34% 42% 40 30% 38% 1,400 35 36% 44% Outbreaks 30 25 1,200 34% 514 39% 454 20 398 499 42% 560 15 454 Outbreaks 1,000 10 548 378 5 418 0 800 415 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 600 273 916 903 890 820 400 772 793 Reported Outbreaks to 719 690 655 567 CDC 200 170 0 Solved Outbreaks 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 150 Solved Outbreaks CO Only † Sou ource: O Outbreak A Alert d database * 10 years of data † Excludes multi-state outbreaks

  9. Foods Linked to Solved Cases, 1998-2007 Outbreaks (N=4,638) Illnesses (N=117,136) 30,000 1,200 Number of Outbreaks 1,000 25,000 Number of Illnesses 20,000 800 600 15,000 10,000 400 200 5,000 0 0 Multi-ingredient (No-Meat) Multi-ingredient (Meat) Poultry Pork Dairy Luncheon/Other Meats Eggs Game Seafood Produce Beef Breads and Bakery Beverages Sou ource: O Outbreak A Alert d database

  10. Identifying High-Risk Foreign Countries Reg egion ons Informat ation S Source ces  Africa  ProMed  Europe  Bites, safe food from farm to fork (ksu.edu)  Western Pacific  The Center for Animal  Latin America Health and Food Safety at  Middle East/North Africa the University of Minnesota  Southeast Asia  STOP E-Alerts

  11. Identifying Factors that May Affect Imports Europe ( (n=97 97) Contam aminan ant No. Percent Western rn P Pacifi fic ( (n=118) Salmonella 20 21% Contam aminan ant No. Percent E. coli 16 16% Gastroenteritis 30 25% Gastroenteritis 12 12% Cholera 21 18% Norovirus 9 9% Contamination 16 14% Cryptosporidium 6 6% Salmonella 9 8% Hepatitis A 6 5% Africa ca ( (n=128) 28) Contam aminan ant No. Percent Cholera 105 82% Gastroenteritis 12 9% Contamination 2 2% Schistosomiasis 2 2% Hepatitis E 2 2% Sou ource: S Safe F Food I ood International R Repo ports

  12. Inspections Case Study Metrics Choices Refused Entry Case Study

  13. Choice of What is Measured Matters  FDA-Track provides useful metrics for internal management but isn’t as useful for informing public about what FDA does.  Public metrics are available in FDA’s budget justification documents, but may not tell a complete story.  Other metrics have to be drawn out from publically available materials on FDA’s website.

  14. Inspections Measured Against Funding $600 13,567 12,853 $500 11,767 FDA Conducted 11,246 10,498 Inspections $400 9,164 8,851 7,597 7,568 8,490 8,045 7,363 7,846 High-Risk $300 Inspections 6,784 6,795 6,750 6,421 6,230 $200 6,182 $100 $0 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 est Sou ource: F FDA B Budget J Justifications

  15. Changes in Allocation of Staff Activities Technical Technical Foreign Assistance & Miscellaneous Assistance & Foreign Miscellaneous Inspections Coordination 1.7% Coordination 1.4% Inspections 2.9% 12.2% 6.3% Training Given 4.8% & Received 12.6% Training Given & Received 10.2% Investigations, Investigations, Recall Audits Domestic Recall Audits & Domestic & Coordination Inspections Coordination Inspections 7.9% 49.9% 17.5% 56.3% Sample Collections Sample 8.8% Collections 2001 2009 7.5% Sou ource: F FDA

  16. Refusals of Imported Produce, 2009- 2010  Data gathered during border Shigella Insanitary 1% refusals can produce 1% Listeria Other 2% 1% Filthy meaningful metrics 12%  Problems for consumers  Data presentation is not user friendly  Coding makes information less accessible to public Pesticide Salmonella Residue 24% 59% Mexico Sou ource: F FDA I Impor port R Refusal R Repo port

  17. Types of Imported Foods Frequently Refused, FY2010 Dressings & Condiments Seafood Other 2% 16% 11% Pasta 2% Chocolate & Cocoa 4% Nuts & Edible Seeds 3% Cheese Vegetables 3% 15% Soft Drinks & Water 4% Multi-Food Dinners 4% Snack Foods 3% Bakery Products Fruits 8% 9% Nonchocolate Candy 8% Spices/Flavors/Salts Sou ource: F FDA I Impor port R Refusal R Repo port 8%

  18. Vanishing Reports Consistency Case Study Seafood HACCP Case Study

  19. Vanishing Data and Inconsistent Reporting  Changes in administrations result in lost data and metrics  Historic budget justifications are no longer available beyond FY2005.  Strategic plans from prior administration difficult to find.  Audit reports on state inspections were taken down.  Metrics information changes  Budget justifications change baseline for measuring high-risk performance after 2004.  Seafood HACCP evaluations stopped reporting overall implementation after 2001.

  20. Recommendation for Consumer Friendly Metrics  Data sources  FDA should make use of publically available and validated data resources.  Baselines  FDA should establish baselines for measuring progress on implementing FSMA.  Consistency  Reporting should be consistent over time.  Baselines, such as past reports and plans should be publically available.  Transparency  FDA should make data used in metrics publically available.

  21. Thank you! David id W. . Plu lunk nkett, J , J.D .D., ., J.M .M. Cen Center f for or Science in the e Pu Public I Inter erest 1220 L 220 L St., ., N NW Su Suite 300 300 Was ashington, D DC 20005 20005 Phone: ( : (202) 2) 7 777-83 8319 19 Fax ax: ( (202 202) 265 265-495 4954 E-mai mail: : dplunkett tt@c @csp spinet. t.org On On the i e int nter ernet: www.csp spinet. t.org and d www.s .saf afefood oodinternat ation onal al.or .org

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