USDA s New Shiga Toxin- Producing Escherichia coli Policy James Hodges Executive Vice President American Meat Institute June 20, 2012
Final Determination and Request for Comments (FDRC) September 20, 2011 - six additional Shiga toxin-producing Escherichia coli (STEC) deemed adulterants in certain beef products.
FDRC Non-intact raw beef including ground beef, its components, and tenderized steaks found to contain STEC O26, O103, O45, O111, O121 and O145 will be prohibited from entering commerce.
FDRC FSIS will initially test trim June 4, 2012 Ground beef testing program will be initiated at a later date
FDRC USDA said this step is part of a government-wide commitment to dealing with emerging microbial threats. President's Food Safety Working Group - public health-focused approach to food safety Prevention Strengthening surveillance and enforcement Improving response.
Annual Foodborne Illness Estimates Known Foodborne Pathogens 1 Unspecified Agents 2 Total Illnesses 9.4 million 38.4 million 47.8 million Hospitalizations 55,961 71,878 127,839 Deaths 1,351 1,686 3,037 Total Illnesses estimated for all FSIS Regulated Products 3 394,770 1 Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. (2011). Foodborne illness acquired in the United States major pathogens. Emerg Infect Dis. 17(1): 7-15. 2 Scallan E, Griffin PM, Angulo FJ, Tauxe RV, and Hoekstra RM. (2011). Foodborne illness acquired in the United States unspecified agents. Emerg Infect Dis. 17(1): 16-22. 3 USDA FY 2013 Budget Summary and Annual Performance Plan. http://www.obpa.usda.gov/budsum/fy13budsum.pdf. Accessed April 15, 2012.
Comparison of O157 and Non-O157 STEC All Food O157 Non-O157 Illnesses 63,153 112,752 Hospitalizations 2,138 271 Hospitalization Rate 46.2% 12.8% Deaths 20 0 Death Rate 0.5% 0.3% Travel Related 8% 4% Source: Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. (2011). Foodborne illness acquired in the United States major pathogens. Emerg Infect Dis. 17(1): 7-15.
Illnesses Attributed to Foodborne Transmission of Known Pathogens 9.4 million Other Viruses 1% Campylobacter 9% STEC O157:H7 1% Non-O157 STEC 1% Listeria monocytogenes 0% Salmonella 11% Norovirus 58% Other Bacteria 17% Parasites 2% Source: Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. (2011). Foodborne illness acquired in the United States major pathogens. Emerg Infect Dis. 17(1): 7-15.
Hospitalizations Attributed to Foodborne Transmission of Known Pathogens 55,961 Other Viruses 1% Campylobacter 9% STEC O157:H7 4% Norovirus 26% Non-O157 STEC 0% Parasites 9% Listeria monocytogenes 0% Other Bacteria 7% Salmonella 35% Source: Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. (2011). Foodborne illness acquired in the United States major pathogens. Emerg Infect Dis. 17(1): 7-15.
Deaths Attributed to Foodborne Transmission of Known Pathogens 1,351 Norovirus 11% Other Viruses 0% Campylobacter 6% STEC O157:H7 1% Non-O157 STEC 0% Listeria monocytogenes 19% Parasites 25% Other Bacteria 10% Salmonella 28% Source: Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. (2011). Foodborne illness acquired in the United States major pathogens. Emerg Infect Dis. 17(1): 7-15.
What FSIS Said in the FDRC We note that the illnesses associated with these strains have not primarily been due to contamination on beef. Food Safety and Inspection Service; 76 Fed. Reg. 58158-58164.
CDC Outbreaks Among Pathogens All Foods: 1998-2008 Source: CDC Foodborne Outbreak Online Database. http://wwwn.cdc.gov/foodborneoutbreaks/. Accessed February 18, 2011.
CDC Foodborne Outbreaks, 1998-2009 Total: 14,091 E. coli O157 Top 6 Non-O157 E. coli 1 Other E. coli Total E. coli Outbreaks All Foods 340 12 31 383 Beef Related 113 0 4 117 % Beef Related 33% 0% 13% 31% Source: CDC Foodborne Outbreak Online Database. http://wwwn.cdc.gov/foodborneoutbreaks/. Accessed December 9, 2011. 1 In August 2010, FSIS announced a Class I recall for 8,500 pounds of ground beef products that may have been contaminated with E. coli O26 and associated with 3 illnesses in New York and Maine. Updated: December 14, 2011
Non-O157 STEC Outbreaks 1 U.S. Year State Serogroup Setting Vehicle 1990 Ohio O111 Home/family outbreak Unknown 1994 Montana O104 Home Pasteurized milk Montana O121 Camp Unknown 1999 Texas O111 Camp Salad bar; Ice from barrel Connecticut O121 Community Recreational lake water Minnesota O145 Daycare Person-to-person 2000 Minnesota O111 Camp Animal contact - calves Washington O103 Banquet hall Water-based punch Utah O111 Camp Irrigation water 2001 Minnesota O111, O51 Camp Animal contact - calves Minnesota O26 Swimming beach Recreational lake water South Dakota O111 Daycare Person-to-person 2004 New York O111 Community Unpasteurized apple cider 2005 Nevada O26 Daycare Person-to-person Oregon O145 Camp Drinking water New York O45 Correctional facility Ill food workers 1 Centers for Disease Control and Protection. http://blogs.cdc.gov/publichealthmatters/files/2010/05/nono157stec_obs_052110.pdf. Accessed June 10, 2011.
Non-O157 STEC Outbreaks 1 U.S. Year State Serogroup Setting Vehicle 2006 North Carolina O45 Family farm Animal contact - goats Nebraska O121 Daycare Person-to-person Utah O121 Catered event Lettuce Massachusetts O26 Community Strawberries, blueberries 2007 Maine O111 Daycare Person-to-person North Dakota O111 Elementary school Person-to-person North Dakota O111 Private home Ground beef Colorado O121, O26, O84 Correctional facility Pasteurized American cheese, margarine New Hampshire O45 Fair petting zoo Animal contact 2008 Oklahoma O111 Restaurant Unknown Minnesota O111 Daycare Person-to-person 2010 Multi-state 2 O145 Food service Romaine lettuce Multi-state 3 O26 Home Ground beef 1 Centers for Disease Control and Protection. http://blogs.cdc.gov/publichealthmatters/files/2010/05/nono157stec_obs_052110.pdf. Accessed June 10, 2011. 2 Centers for Disease Control and Protection. http://www.cdc.gov/ecoli/2010/ecoli_o145/index.html. Accessed June 10, 2011. 3 Food Safety and Inspection Service. http://www.fsis.usda.gov/news_&_events/recall_050_2010_release/index.asp. Accessed June 10, 2011.
What FSIS Said in the FDRC As we have stated, controls for E. coli O157:H7 already in place should be as effective in controlling non-o157 STEC as in controlling E. coli O157:H7. Food Safety and Inspection Service; 76 Fed. Reg. 58158-58164.
AMI Foundation Research AMI Foundation (AMIF) recognized potential human health implications of pstec in ground beef. AMIF Research Advisory Committee set research agenda to determine risk of pstec in beef products.
Information to Enhance Current and Future E. coli O157:H7 Risk Assessments Determine the risk associated with non- O157 Shiga-toxin producing E. coli from beef products.
What FSIS Said in the FDRC As explained in the Expected Costs and Expected Benefits Sections, there are uncertainties in our cost and benefit estimates. For example, we do not know how many illnesses will actually be prevented. It is not clear whether on net there will be a reduction in the number of illnesses. Food Safety and Inspection Service; 76 Fed. Reg. 58158-58164
What FSIS Said in the FDRC It is also challenging to know what the industry cost will be because it is difficult to predict how many establishments will start to test and what the size distribution will be or to what extent industry will take additional measures that will prevent, reduce, or control those hazards, as they do with regard to O157 STEC. Food Safety and Inspection Service; 76 Fed. Reg. 58158-58164
FDRC Logistical Issues Public comments noted inadequacy of FSIS cost analysis. FSIS estimates industry implementation costs will range from $7.9 to 10.5 million. Industry estimates the policy could exceed $300 million annually.
Beef Industry Cost Analysis Industry Estimates (Millions) Low High Product Diverted to Cooking $39.2 $78.4 Laboratory Services 2.5 2.9 Process Disruption 58.8 98.0 Recalls 72.0 144.0 Total Annual Costs 172.5 323.3 Comment submitted to the Public Record by Beef Industry Food Safety Council; Docket No: FSIS-2010-0023; Shiga Toxin-Producing Escherichia coli in Certain Raw Beef Products.
FDRC Technical Issues Existing methods to detect non-o157 STEC are not sufficiently advanced for use by commercial operations. Preliminary data show large number of potential positives during first screening for non-o157 STEC but most of those will confirm negative.
FDRC Technical Issues The use of lengthy laboratory confirmation methods is not a viable option for in-plant testing. A reliable rapid screening test is needed. Disposition decisions are based on the results of screening tests in 18 hours or less. Inaccurate screening cause needless loss of product or downgrading the product value.
FDRC Technical Issues Detection of non-o157 STEC requires sophisticated equipment and experienced technicians to run the analyses If FSIS requires testing to validate a plant s HACCP program, small and medium size operations will be forced to upgrade testing protocols that are currently used or use outside fee-for-service laboratories.
Industry Actions Preventive food safety process management programs for controlling O157:H7 are also effective in controlling non-o157 STEC. Microbial interventions currently used in beef slaughter facilities to control O157:H7 also control non-o157 STEC and O157:H7 is an effective indicator organism for other STEC.
Industry Actions Additional pathogen control technologies to specifically target STEC other than O157:H7 are unnecessary Testing for O157:H7 is an effective screening program for other STEC and a method to verify that process control systems.
USDA OIG Report May 9 - OIG report Application of FSIS Sampling Protocol for Testing Beef Trim for E. coli O157:H7. overall, industry was taking appropriate steps to help ensure that U.S. beef is safe from E. coli contamination, recognizing that regardless of how stringently the industry tests for E. coli, there was always an inherent risk of the presence in slaughter plants.
FDRC Trade Implications Likely violates the United States WTO obligations outlined under Article 5 of the Agreement on the Application of SPS Measures. Several governments were concerned about Absence of an adequate risk assessment; Lack of viable testing platforms; and Potential for an unjustified disruption in trade and its implications.
FSIS Response to Public Comments on FDRC May 31 E. coli O157:H7 is not an index organism, but an indicator to demonstrate process control After 90 days, FSA will be completed if STEC found No requirement for STEC testing, but establishments should be able to support that decision.
FSIS Response to Public Comments on FDRC May 31 When FSIS detects STEC, the sample will be sent to ARS for additional STEC testing When expanded testing begins, all product will be sampled regardless of kill date Reassessment will be based on FSIS confirmed positive findings.
Final Thoughts Interventions that control E. coli O157:H7 also control other STEC. Plants continuously test for E. coli O157:H7 to validate the effectiveness of their food safety process management system. Plants will test for non-o157 STEC to collect information for periodically reassessing their systems.
A food safety process management system in control for E. coli O157:H7 is also a system in control for other STEC.
USDA s New Shiga Toxin- Producing Escherichia coli Policy James Hodges Executive Vice President American Meat Institute June 20, 2012