SEMA_________________________________

SOUTHEASTERN MEAT ASSOCIATION
P.O. Box 620777; Oviedo, FL 32762 Phone: 407-365-5661

Meeting the Industry Needs

Almost 190 people from the U.S. and Canada attended the E. coli Conference in Chicago, August 18th & 19th. NAMP organized the E. coli Conference with the support of the Beef Industry Food Safety Council (BIFSCo) and in collaboration for the first time with USDA’s Food Safety and Inspection Service (FSIS). SEMA was one of the twenty-one North American meat industry trade organizations and trade publications that partnered with NAMP. Below is a review of the conference provided by NAMP.

FSIS was represented by an unprecedented four agency leaders:

• Alfred Almanza, Administrator ,
• Dr. Kenneth Peterson, Assistant Administrator of Field Operations,
• Dr. Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development, and
• Dr. Karlease Kelly, Assistant Administrator for Outreach, Employee
  Education and Training

Marsden Addresses E. coli O157:H7 Challenges and Solutions

Dr. James Marsden, NAMP Senior Science Advisor and Regents Distinguished Professor of Food Safety and Security at Kansas State University, kicked off the conference by addressing the challenges North American further processors face with E. coli O157:H7.

The challenge for further processors is that pathogens enter the process in their raw materials, so they must rely on upstream interventions, testing of trimmings, and the few available processing interventions to reduce their risk.

Marsden told attendees that E. coli O157:H7 must be addressed through an integrated process which includes:

1) A vaccine to reduce the incidence in cattle
2) Washing of live cattle prior to slaughter
3) Enhanced slaughter interventions
4) Post-chill carcass pasteurization
5) Technologies to reduce surface contamination of sub-primals prior to blade tenderization
6) N-60 testing of trimmings destined for ground beef and finished product testing to verify process control
7) Interventions to reduce contamination on beef trimmings prior to grinding
8) Pasteurization using high hydrostatic pressure or electron beam treatment.

Marsden later explored pasteurization technologies in more detail:

• Irradiation: Irradiation can eliminate pathogens from raw meat and some companies have been selling irradiated product for years with great success. However, the term irradiation and the required radura symbol on labels is a hurdle for widespread consumer acceptance. Marsden provided suggestions for FDA and USDA to work together to make irradiation a more viable option for the beef industry.
• High Hydrostatic Pressure (HPP): HPP has the potential to eliminate E. coli O157:H7 in beef trimmings, coarse ground beef, or consumer packaged ground beef with no possibility of recontamination when applied to consumer packages. Marsden sees HPP as a viable intervention option that can make a difference for the industry.

Marsden also led a panel discussion of NAMP members who currently use antimicrobial interventions in their processes, which was well-received by conference participants.

Engeljohn and Petersen Convey Current FSIS Views

Dr. Dan Engeljohn, Deputy Assistant Administrator for the FSIS Office of Policy and Program Development, addressed conference attendees on Day One, and was followed by Dr. Ken Petersen, Assistant Administrator FSIS Office of Field Operations, on Day Two.
Engeljohn shared that FSIS test results for ground beef as of Aug. 3 showed 21 of 7236 samples positive for a percent positive rate of 0.29%. For the same time period last year, there were 25 of 7129 samples positive, or 0.35%.

The FSIS beef trim sampling program, which began in 2007, has shown that very small establishments have the lowest percent positive rate. However, Engeljohn also announced that, based on this summer’s recalls, it is safe to assume that illnesses associated with Salmonella in raw product are likely to trigger FSIS pursuit of a voluntary recall to protect public health.
He further shared data showing a decline in the percent of raw ground beef sample sets meeting the Salmonella performance standard.

Engeljohn shared the following current FSIS policy considerations, which highlights what the policy office is focusing on for the future for E. coli O157:H7:

• Assess effectiveness of comprehensive E. coli O157:H7 policy issuances (Directive 10010.1) and bench trim testing program,
• Ensure suppliers and product types are listed in STEPS,
• Pursue use of receiver (establishment) testing data implicating sole source suppliers of positive product,
• Issue FSIS criteria for assessing prudent high event day determinations,
• Issue N-60 labeling criteria,
• Initiate design development of a post-hide/pre-evisceration baseline of carcasses,
• Resolve laboratory method for discerning which of the 6 serogroups of non-O157 STECs are present in samples,
• Further consider a broader adulteration determination for the food safety hazard- not product based (e.g. primals),
• Other areas of focus include food safety controls at retail and consumer education

Petersen focused on what is expected in a further processor’s Hazard Analysis and HACCP Plan. He noted considerations are different for an establishment that 1) cuts intact steaks, 2) uses bench trim for raw ground beef, and/or 3) mechanically tenderizes steaks.

Petersen acknowledged the challenge E. coli O157:H7 presents: that it is present at very low levels, appears sporadically, and can cause severe illness.

Petersen noted that a key point for further processors is to have on-going verification that its HACCP plan is being effectively implemented. Establishments must maintain documents to support those activities and the frequency at which it performs them.

For most establishments that have declared E. coli O157:H7 not reasonably likely to occur, that means verification of pre-requisite programs. Food Safety Assessments have shown that receiving establishments do not have adequate documentation or understanding of their suppliers programs.
Petersen said annual letters of guarantee or third party audits are not adequate to support their decisions because these documents do not constitute adequate ongoing verification.

Petersen suggested receiving establishments should ask their suppliers the following questions:

• Production practices: do they use single or multiple interventions?
• What is the incidence of the pathogen in the suppliers finished raw beef product?
• Is in-plant testing performed?
• What is the level of confidence of the sample results?
• What methods are used to notify receivers about issues at suppliers?

Petersen also addressed FSIS Notice 05-09 (now part of Directive 10010.1). He said FSIS recognizes that small establishments cannot obtain meaningful certificates of analysis (COAs) when they purchase through a broker. He discussed the trimming and washing option, and stressed that “reduction” is the operative word. Establishments should focus on properly applying a wash and trim program without creating an insanitary environment. Plants can develop a procedure and validate that the procedure is being followed.

At this time, FSIS does not require validating an outcome of a reduction of E. coli O157:H7.

Mandatory Recalls Plans to Be a Reality Soon

Dr. Karlease Kelly, Assistant Administrator of the FSIS Office of Outreach and Employee Education and Training, gave attendees of last week’s conference guidance on developing a recall plan. She presented information from FSIS Directive 8080.1, Revision 5, Recall of Meat and Poultry Products, Attachment 1, which can be found at http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1Rev5.pdf

A recall plan will become mandatory in the future, as prescribed by the last Farm Bill.

E. coli Conference Focuses on Reducing Risk

An all-star line-up of industry experts presented the latest information on E. coli control to conference attendees last week.

Highlights:

• Bob Hibbert of the law firm K&L Gates discussed the legal framework surrounding E. coli O157:H7. He covered several theories which contribute to the current legal framework, including product adulteration, sanitation, pathogen reduction, HACCP, public health, and liability. He concluded that formal rulemaking would be the preferred option to deal with the issues and interests at hand.
• Bobby Palesano of the International HACCP Alliance addressed how to identify risk in an establishment’s process. He stated processors must consider the risks before the product enters the establishment, during the process, and after leaving the establishment. Palesano’s presentation covered all areas of risk to consider, and he concluded with the following four factors for success:
  - know the regulations
  - know your processes
  - have confidence in your system, and
  - be familiar with the FSA tools
  Palesano later reviewed those tools in a separate presentation.
• Barb Masters of the law firm Olsson, Frank, and Weeda told participants how to prepare for a recall. She addressed specific lessons learned from the major recalls of the past several years, and told attendees to:
  - be proactive: have well designed systems and make sure they are implemented
  - be prepared: have a food recall plan and conduct mock recalls, including mock media and mock effectiveness checks
  - if a recall occurs, be responsive
• Scott Goltry of the American Meat Institute (AMI) and Angie Siemens of Cargill Meat Solutions addressed ways for processors to communicate with their suppliers. They told of initiatives being taken by suppliers to address “trim trigger events” when trim testing results pass a designated threshold. They told processors the importance of knowing their suppliers, of being familiar with the key contact at each supplying establishment, and of informing suppliers how products are being used.

FSIS Directive 10010.1, Rev. 2 Reissued 7/31/09

The Food Safety and Inspection Service (FSIS) has reissued this directive to incorporate in one document the instructions that the Agency has issued in multiple notices regarding Escherichia coli (E. coli) O157:H7.

FSIS has revised this directive to include instructions for:

• Routine verification sampling of beef manufacturing trimmings and other raw ground beef and raw beef patty components for E. coli O157:H7 at the slaughter establishments that produced those components
• Multiple follow-up samples of raw ground beef, beef manufacturing trimmings, and other raw ground beef and raw beef patty components in response to an FSIS positive E. coli O157:H7 result or another Federal or State entity’s positive E. coli O157:H7 result
• Submitting samples to the laboratory without waiting for the establishment
  to complete pre-shipment review

Factors to consider determining whether to take an enforcement action when FSIS finds samples positive for E. coli O157:H7:

• Collecting 8 follow-up samples when the Agricultural Marketing Service (AMS) finds product positive for E. coli O157:H7
• Verifying that establishments producing mechanically tenderized or injected raw or heat-treated beef products have considered E. coli O157:H7 in their hazard analyses for these products
• Verifying the adequacy of Critical Control Points (CCPs) or prerequisite programs that address E. coli O157:H7
• Reviewing establishment records for E. coli O157:H7 testing of trim when the establishment has never identified a positive result
• Increased sampling based on rates in FSIS new sampling algorithm
• Routinely verifying that adulterated product is denatured before it is shipped to a landfill operation or renderer
• Policy Analysis Division (PAD) in the Office of Policy and Program Development (OPPD) responsibilities
• Collecting a sample of ground product at the start of operations when product is scheduled to be ground later during the day, provided the establishment meets certain criteria
• Collecting follow-up samples of beef manufacturing trimmings, rather than ground product, at combination slaughter/processing establishments in response to an FSIS (or other State or Federal entity) positive result in the ground product
• Performing a HACCP 02 procedure at the originating supplying slaughter establishment when notified by the District Office (DO) through the use of FSIS Form 8140-1 (9 CFR 320.7)
• Sampling product for E. coli O157:H7 that may contain a mixture of ground beef and non-beef species
• Actions FSIS will take when slaughter suppliers that produce primals or subprimals are identified in System Tracking E. coli O157:H7 – Positive Suppliers (STEPS) because they supplied primals or subprimals that were used to produce raw ground beef product that FSIS found positive for E. coli O157:H7

For more information go to: http://www.fsis.usda.gov/regulations/index.asp

FSIS-ASK: Certificate of Analysis (COA) or Purchase Specifications

Question: Background: In FSIS Directive 5420.1 Rev 6 on Page 5, Paragraph X.A it states: FSIS has urged establishments to develop functional Food Defense Plans to set out control measures to prevent intentional adulteration of product. Although not required, FSIS considers these plans to be important preparatory measures. The plan should be developed, written, implemented, assessed, and maintained if it is to be functional.

Who determines an establishment's written food defense plan is functional?

Answer: As stated in Section XIV (E) - Multiple Occurrences of The Same Food Defense Vulnerability, upon receipt and review of the third FSIS 5420-1 Form from the requesting District Office, the Office of Data Integration and Food Protection (ODIFP) will determine whether the establishment has a functional Food Defense Plan in place.

SEMA Member News

Lowell Packing: August 3rd Scott and Darchelle Downing became the proud parents of Wyatt Lowell Downing. Wyatt weighed 6 lbs 10 oz., he and Darchelle are doing just fine.

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Things to Ponder . . . . . . . . .
"A man’s feet should be planted in his country,
but his eyes should survey the world."
George Santayana (1863-1952)
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