Guy H. Loneragan La RecherchéSystématique des 7 STECs dans la Viande Hachée aux USA: Premier Bilan Après 1 an de SteakExpert 2013 Angers, France 11 au 12 Juin, 2013 Programme FSIS
Background Information Informed regulatory oversight and industry response to STEC O157 crises were effective Opportunities for further improvement Reported Human cases / 100,000 2
Background Information Some abattoirs now excel at microbial process control Implementation and improvement of HACCP plans Are they achieving achievable control? USDA/FSIS data ~90% decline from 2001 10,000 to 14,000 tests per year 3
Non-O157 STEC Observed non-o157 STEC incidence is increasing What of the trueincidence? From: http://health.state.ga.us/pdfs/eip/conference/2012/7-rajmody.pdf 4
Non-O157 STEC Likely that observed increase is due to increased testing and reporting From: DOI: 10.1089/fpd.2012.1401 5
Regulation Increased awareness of the role of non-o157 STEC in illness USDA/FSIS has regulatory authority over: Meat and poultry Egg products Since 4 Juin, 2012, 6 non-o157 STEC serogroupsconsidered adulterants in: Non-intact raw beef products Raw, intact beef products intended for use in raw non-intact product 6
Regulation E. coli O157:H7 is an adulterant STEC O157:H2/H21/etc. are not considered adulterants Non-O157 STEC serogroups (Gould. DOI: 10.1089/fpd.2012.1401) Serogroup H antigens O26 H1, H11, H12, NM O45 H2, NM O103 H2, H8, H11, H25, NM O111 H2, H8, H11, NM O121 H9, H19, NM O145 H25, H28, NM 6 serogroups include at least (but likely more than) 15 serotypes 7
Regulation USDA/FSIS began testing components of RGB (typically referred to as beef trimmings or trim) MLG 5B.03 PCR of enrichment of 375g for stx, eae Screen positive PCR for O serogroups Potential positive IMS, selective plating and agglutination Presumptive positive Biochemical and PCR for stx, eae, and wzx gene Confirmed positive 8
USDA/FSIS Trim Verification 2012 *At least 15 different serotypes 9
USDA/FSIS Trim Verification 2012 *At least 15 different serotypes 10
USDA/FSIS Trim Verification 2012 *Beef=product from feedlot, cow, bull **~20% of follow-up tests were positive following a RGBC positive 11
USDA/FSIS Trim Verification 2013 *At least 15 different serotypes 12
Positives 2013 O103 17JAN2013 Puerto Rico O103 14MAR2013 Florida O103 19MAR2013 Wisconsin* O145 05APR2013 Kansas O103 15APR2013 Missouri O26 18APR2013 Missouri O26 22APR2013 South Carolina *potentially associated with a follow-up positive 13
USDA/FSIS Trim Verification 2013 14
Government Testing of Beef Trimmings Non-O157 STECs are occasionally isolated from beef trimmings intended for RGB production All (but STEC O45) have been recovered Unclear, however, if serotypes recovered are similar to those over-represented in human illness E. coli O26:H11 versus E. coli O26:H12? Is this important to know? Initial (preliminary) evidence identifies opportunities for improvement in process control primarily in small and veal abattoirs 15
Response to Regulation Thoughtwas that abattoirs would test beef trimmings for E. coli O157:H7 and non-o157 STEC Development and marketing of test kit products Relatively little non-o157 STEC testing In general, industry focus has been reassessment of HACCP plans to control E. colio157 andnon-o157 STEC (in addition to other hazards) While not completely harmonious, most data indicate that interventionsthat are effective against E. coli O157 are also effective against non-o157 STEC Evidence supports that a systemin control for E. coli O157 is a system in control for non-o157 STEC 16
Response to Regulation This approach I believe demonstrates reasoned deliberation and collaboration between industry and regulators Testing finished product (while it clearly has its place) is the most proximate approach yet in a well controlled system, is of limited value Meaningful (and incremental improvements to) process control is more effective yet abstract to many What is the appropriate balance of focus on process control and testing of finished product? Question for food producers and USDA/FSIS 17
Supporting Evidence Laboratory evaluation of interventions Matched assays from multiple abattoirs N=1,195 assays (N60 sampling or equivalent) E. coli O157: 0 positive assays non-o157 STEC 45 potential positives 3 presumptive positives 0 confirmed positives (i.e., all considered negative) 18
Supporting Evidence A large, multi-site abattoir performed a series of observational studies Non-O157 testing when E. coli O157:H7 was identified more commonly (event periods) Potential positive only (no further confirmation) Outcomes were correlated (P=0.045) If E. coli O157:H7 assay was negative then 80% lower probability of a potential non-o157 STEC positive OR when positive for E. coli O157:H7, then a 5-fold increase in probability of a potentialnon-o157 STEC positive 19
Surrogate Organisms Cocktail of generic E. coli that behave similarly to E. coli O157 and S. Typhimurium Evidence they are appropriate for STEC Inoculated beef carcass in the chuck area Sampling sites: 1 Inoculated, sampled before treatment 2 Inoculated, sampled after treatment 3 Uninoculated, sampled before treatment 4 Uninoculated, sampled after treatment Meaningful reductions used as evidence of systemic control
What have we Learned? To date, data indicate it is possible to occasionally identify non-o157 STEC on beef Rare to observe illnesses attributable to beef Serotype distribution? Most data (laboratory, observational, surrogates, etc.) indicate that a process that is in control for E. coli O157 is also in control for non-o157 STEC A process that is out of control is also non-discriminatory Industry belief that implementation of effective HACCP plans and assays targeting E. coli O157 is adequate 21
What have we Learned? Assays are generally very good at detection of isolates inoculated into beef samples Excellent sensitivity and LOD In mixed cultures, however, initial assay kits lacked sufficient specificity to provide actionable information to producers 45 potential, 3 presumptive, 0 confirmed Time to confirmation Does confirmation lack sensitivity? 22
What have we Learned? Incremental (and meaningful) improvements in assays Eae subtypes (β, γ, θ, ε) Pathogen capture single STEC target or one target per STEC (e.g., CRISPR) nleb, espk, Z2098, Z2099 This approach makes very good public health sense However, USDA/FSIS has defined the adulterant Stx, eae, and of the 6 serogroups If a rarely-pathogenic STEC O26 (e.g., E. coli O26:H12) is not detected by because it lacks eaeβfor example, the product is still officially adulterated Opportunity for policy improvement 23
Opportunities from What we have Learned Revisit assumptions of non-o157 STEC Based on knowledge of E. coli O157:H7 1.Assumed to be EHEC like High diversity of virulence within serogroups 2.Cattle are a reservoir of EHEC-like non-o157 STEC Logical yet little data to support this 3.Beef is an important source of non-o157 STEC Typically when studying non-o157 STEC, we have to study/evaluate isolates from non-beef foods 24
Opportunities from What we have Learned Data needs Food-source attribution QMRA to estimate likely public-health impact of control of non-o157 STEC in beef products Current Risk Profile a reasonable start Second/Third-generation assays USDA/FSIS policy development Testing is valuable in poorly controlled processes Industry believes that effective process control of E. coli O157 also controls non-o157 STEC Value when a process is in control? An outbreak away from a testing mandate 25
Merci beaucoup pour votre attention Un grand merciàeliviapour l'invitation àparticiper ànouveau aux Journées SteakExpert Patrice Arbault JBS Technical Services Team Colleagues Contact Information: Guy.Loneragan@TTU.edu +1 (806) 742-2805 x 268 26