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FSIS Set to Implement Non-O157 E. coli Policy Next Week

Just days before the agency is set to begin testing raw beef trimmings for more strains of disease-causing E. coli, the Food Safety and Inspection Service issued a detailed response to comments it has received about the new policy.

The new document, published in the Federal Register on Tuesday, confirms that despite industry calls for delay, FSIS will begin testing trimmings for six additional Shiga toxin-producing E. coli (STEC) next week on June 4. As of that date, any raw, non-intact beef products or components contaminated with STECs O26, O45, O103, O111, O121, and O145, will be legally considered adulterated — just as the agency has long treated E. coli O157:H7.

ecolipetri_iphone.jpgThe agency also said that it will issue a Federal Register notice to implement routine verification testing for the six STECs in additional raw beef products, including ground beef.

The policy rollout has not come without challenges. When FSIS first announced its intent to consider more non-O157 STEC adulterants, it said the verification and testing program would begin on March 5, 2012. But the agency eventually pushed back the implementation date to June 4, 2012 to “allow establishments time to implement appropriate changes in their food safety systems, including changes in process control procedures.”

In its response to comments, FSIS said that it disagreed with several of the reasons cited by those seeking a delay, including requests to conduct a baseline study before moving forward with the policy.

“FSIS has concluded that a baseline is neither necessary nor warranted before implementation of the FSIS verification sampling and testing program,” said the agency in the document. “These organisms are present in beef products in the United States; the evidence for this is presented in the risk profile. FSIS considers the data on non-O157 STECs obtained by the Agricultural Research Service (ARS) at a limited number of slaughter establishments to be evidence that the pathogens should be considered adulterants and are capable of causing illness.”

“FSIS also considered data collected by the person who petitioned the Agency to declare these pathogens to be adulterants in a limited geographical retail area,” added the document, presumably referring to the testing commissioned by food safety attorney Bill Marler (publisher of Food Safety News), who petitioned FSIS to consider non-O157 STECs adulterants in 2009.

Marler said he was pleased the testing project helped back up the new policy.

“Although the cost of the testing was high – just over $500,000 – it helped support that non-E. coli O157 bacteria were still getting through the beef industry’s safety net of interventions,” said Marler. “I think adding the bugs as adulterants will prompt more innovation by industry that, in the long run, will benefit both consumers and industry by driving down the number of people sickened.”

FSIS also pointed to a report from the Centers for Disease Control and Prevention (CDC), which clearly showed that non-O157 STEC “pose a significant public health burden in the United States,” to support the agency’s position.

The document added that, “FSIS and the CDC believe that there are more unreported and unconfirmed illnesses associated with the specified non-O157 STECs than with E. coli O157:H7.”

Though FSIS is moving forward with the policy next week, the agency is planning to conduct a carcass baseline study in 2013 — not just for non-O157 STEC, but also for E. coli O157:H7, Salmonella and indicator bacteria. The study will look at contamination immediately after hide removal but before food safety interventions and evisceration.

On the whole, the agency said that the new non-O157 STEC testing policy is not meant to be a panacea, but to help regulators determine whether the industry is controlling the pathogens to keep them out of the food supply.

“FSIS acknowledges that the best approach to reducing STEC contamination lies not in comprehensive end-product testing but in the development and implementation of science-based preventive controls, with end-product testing to verify process control,” read the notice. “FSIS’s non-O157 STEC testing program will improve food safety because FSIS anticipates that establishments may voluntarily make changes to their food safety systems in response to the new testing. For example, establishments may initiate a testing program for non-O157 STECs or may add new interventions to address pathogens.”

The notice also addressed the concerns about imported beef products and whether the new policy might violate the United States’ obligations under the Agreement on Sanitary and Phytosanitary (SPS) Measures, a World Trade Organization accord.

FSIS stated that the agency has notified trading partners about the policy, including conducting video and teleconferences to help foreign governments understand the new measure. The agency said it will treat incoming foreign products the same way it treats product tested for E. coli O157: H7.

A draft of the 32-page notice can be found here.

 

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