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Just yesterday, FSIS formally published its final determination and request for comments relating to its decision last week to declare non-O157 STECs as adulterants in ground beef and trim products. Since the announcement last week, there has been a great deal of concern within the industry over the scope and breadth of the proposed new regulations.  

Generally, FSIS intends to carry out verification procedures, including sampling and testing to ensure control of both O157:H7 and, now, the six other STECs.

To allow industry time to implement possible changes to food safety systems, however, FSIS will generally not regard products found to have these pathogens as formally "adulterated" until it begins this routine testing. As of right now, FSIS intends to begin a routine sampling program for the non-O157 STECs no later than March 5, 2012.

A significant concern for industry at this early stage is the elapsed time between micro-sampling and results. At this point, FSIS estimates that negative (or presumptive positive) results could be available within 48 hours of sampling. For samples that are initially reactive an additional three to five days may be necessary for a confirmed positive or confirmed negative result.

Fortunately, the antimicrobial interventions used by beef manufacturers to control E. coli O157:H7 are believed to be equally effective in controlling non-O157 STECs. Thus, while it is inviting industry comment, the agency "does not anticipate" at this point that industry will have to incur additional cost by implementing new or different interventions. They do, however, “anticipate that many firms will want to implement their own testing programs and even conduct the same kind of testing that FSIS plans to carry out.”

According to FSIS, establishments that manufacture raw, non-intact beef products (or intact raw beef components of those products) will be expected to evaluate whether non-O157:H7 STECs are a hazard reasonably likely to occur. If a company’s HACCP plan cites O157 as a hazard reasonably likely to occur. If so, those companies will also be expected to reassess their HAACP plans and address the new hazard accordingly; likely by testing for it.

Finally, in the event that FSIS finds a non-O157 STEC in a regulatory sample, it will conduct a for cause food safety assessment (FSA), "as it does currently for E. coli O157:H7-positive [regulatory] samples."

With this as the prelude, FSIS is inviting comments on its proposal from public and industry. Since it currently intends to begin testing for non-O157:H7 STECs as soon as March 2012, however, the agency recommends that any comments be submitted no later than November 1, 2011. Thus, while rules are never really meant to be broken, they are, at least in this case, meant to be critiqued. 

So, while FSIS has indeed created a "new set rules" as they apply to non-O157:H7 STECs, you may be able to influence, at least in part, how those new rules will ultimately be implemented and enforced. 

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After years of deliberation, USDA has formally declared six additional pathogenic E. coli serogroups (O26, O45, O103, O111, O121 and O145) to be adulterants in non-intact raw beef.

From this point forward, any raw ground beef or tenderized steaks found to contain these pathogens will be prohibited from sale to consumers.

While some within the beef industry reacted warmly to the news, others where not so receptive. In a September 13^th, press release, AMI Executive Vice President James H. Hodges criticized the foundation of the new policy:

“This new policy is not supported by science and likely will not benefit public health.  Indeed, in the policy notice USDA acknowledged that ‘we do not know how many illnesses will actually be prevented.  It is not clear whether or not there will be a reduction in the number of illnesses.  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.”  

Indeed, in many ways, the issue has given way to more questions than answers. Processors, especially small ones, are asking how they will be able to adapt to the likely array of new testing requirements and protocols which may soon be be expected of industry. Moreover, as of today, the time needed to carryout the tests has been causing significant problems for those companies which are already testing.

“It can be a cumbersome process,” Craig Letch, director of quality assurance for Beef Products Inc., told Meatingplace. Letch said that while testing for E. coli O157:H7 can hold up a product shipment for days, there have been times when products being tested for the new strains have been held for even longer, “if in fact you have reactivity.”

Many companies, especially those dealing in fresh products, simply do not have the space or capacity to hold their products for nearly a week before shipment. The added expense of not just testing, but then instituting new programs and holding product for extended periods of time, could significantly and adversely affect both industry and consumers alike.

I have always been the first to commend USDA for demonstrating a real commitment to food safety. In the absence of any real studies supporting this decision, however, the policy appears to have been driven more by sensationalism than by science. 

While it may feel good to declare a bug an adulterant, there is little to show, at this point, that it will have any effect on making our food safer.

I sincerely hope that I am proven wrong.

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The Food Safety and Inspection Service (FSIS) may be one step closer to taking a substantive stance regarding the non-O157 STEC issue. Recent statements made by the FSIS describe the agency’s progress, and hint at additional regulation.

In October 2009, Bill Marler (a national plaintiffs’ food lawyer) submitted an interpretive rule petition to the FSIS requesting that all non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) be declared adulterants in ground beef. In response to the petition, FSIS stated that when it had an appropriate laboratory method for conducting regulatory sampling for non-O157 STECs, and had developed a plan for how it intended to address the issue, it would make the plan available to the public for comment and would, at the same time, issue a final response to the petition.

Two months ago, Dr. Elisabeth Hagen, Under Secretary for Food Safety, touched on the non-O157 STEC issue at the 2010 National Food Policy Conference and in a statement to the New York Times. Dr. Hagen said that FSIS policies “need to evolve to address a broader range of pathogens, beyond E. coli O157:H7.” She queried how we best protect consumers from pathogens that are not addressed by current policies.

A few weeks ago at the North American Meat Processors (NAMP) annual conference, Dr. Dan Engeljohn revealed that FSIS is “very close to having a [test] methodology for all six” non-O157 STECs. Dr. Engeljohn is the FSIS’s chief policy writer. He reiterated the steps which FSIS will take following completion of the test methodology – a Federal Register notice will outline an enforcement strategy, followed by public meetings and comment, and the issuance of guidance.

While FSIS action is on the horizon, we of course urge the agency to consider carefully the American Meat Institute’s recommendations on non-O157 STECs, summarized as follows:

1. Focus on Prevention
2. Conduct a Comprehensive Public Health Risk Assessment
3. Validate Analytical Laboratory Test Methods
4. Conduct a Baseline Survey of Non-O157:H7 STECs on Beef Products
5. Measure Progress Based on the Public Health Outcome
6. Expedite Approval of New Microbial Interventions
7. Determine Impact on International Trade
8. Provide an Open and Transparent Public Policy Process

A focus on prevention should remain the number one priority. The AMI said it well: Making a pathogen illegal through a policy change will not prevent this pathogen from occurring. Making non-O157:H7 STECs illegal could also divert scarce resources away from enhancing food safety prevention efforts. Click on the following link to view the AMI’s Position on non-O157:H7 STECs.

As noted, a rush to implement test and hold programs for non-O157 STECs could potentially distract from research into even better interventions that prevent O157 and non-O157 contamination alike. The industry’s resistance to additional testing, however, is poorly perceived by consumers because the general public fails to realize the incredible shortcomings of testing. Safer food flows from preventing contamination in the first instance, rather than searching for a needle in a haystack.

And, lest consumers believe that industry is only concerned about the bottom line, I will take this opportunity to commend our food manufacturers on the incredible effort and investment which has greatly improved food safety in the past 15 years. Dr. Engeljohn specifically applauded the beef industry at the NAMP conference. The AMI Foundation alone has millions of dollars in grants towards developing new food safety technologies, and major industry manufacturers have spent billions on food safety improvements.

Hopefully, FSIS respectfully considers the industry’s perspective on non-O157 STECs. We, of course, will continue to follow this issue closely.

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The “E. coli Traceability and Eradication Act” was introduced by Rep. Rosa DeLauro (D-CT) on July 29. The bill seeks to amend the Federal Meat Inspection Act (“FMIA”) on two major fronts. First, it mandates testing beef for all Shiga toxin-producing E. coli strains, not just E. coli O157:H7. Second, it prescribes extra testing and additional reporting requirements.

The bill, if passed, would require boneless beef manufacturing trimmings and other raw ground beef components to be tested for “Shiga toxin-producing E. coli.” As we previously reported, there is and has been a corresponding push to label non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) as adulterants under the FMIA.

In response to these efforts, however, the FSIS previously announced it could not reach a decision regarding the validity of branding non-O157 STECs as adulterants “until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.” Indeed, even if this bill were to advance, according to the American Meat Institute (“AMI”), there is no test currently available to easily detect the other six non-O157 STEC strains.

In any event, DeLauro’s act calls upon beef slaughterhouses, processing establishments, and grinding facilities to test for and report on the presence of Shiga toxin-producing E. coli at the following points:

• One test at the slaughterhouse or processing establishment at which source trim was produced, and one test of the source trim or bench trim at the receiving facility prior to combining with other lots from different sources.

• If the source trim and grinding occurs at the same facility, one test of the source trim and one test of the final ground product.

The bill does not specify the specific sampling or testing procedures that should be used, but directs the Secretary of Agriculture to develop standards that “enable rapid tracing to the source of contamination.” In turn, the bill would require manufacturers to report any positive or presumptive positive results directly to the Secretary of Agriculture through electronic means within 24 hours after receipt of the results. USDA would then be required to carry out an investigation to identify the original source of the contamination.

In its current form, the bill would also require the USDA, following a positive test result, to conduct supplementary sampling at the establishment and its suppliers for 15 days. In turn, a processor would be listed on the USDA’s website as a “habitual violator” if it received positive results for 3 consecutive days or on more than 10 instances per year.

Given the difficult scientific issues associated with non-O157:H7 STECs (and limitations in testing for any pathogen), and Congress’ current focus on the FDA’s Food Safety Enforcement Act, we think it is unlikely DeLauro’s proposed legislation will pass anytime soon.

With that said, however, the bill has been referred to the Committee on Agriculture, and we of course we will continue to monitor its status.

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