A petition was filed with the Food Safety and Inspection Service (FSIS) in October 2009 requesting FSIS issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing Escherichia coli (STEC), including non-O157 serotypes, to be adulterants. This has not happened, at least not yet.
While FSIS has acknowledged an expedited review of the petition, the delay is the result of practical impediments. For example, the recently published FSIS laboratory method for the organisms is long and detailed; there is no generally recognized rapid method available commercially to handle the literally millions of samples that could have to be analyzed by industry, let alone the government samples. Also, FSIS has convened a group of scientists to study available data on the non-O157 STEC.
Ultimately, FSIS will respond to the petition. We expect a Federal Register Notice to issue shortly. However, it would appear that we should not anticipate a repeat of how E. coli O157:H7 was declared an adulterant: an announcement of the adulteration policy at a trade meeting with no prior discussion or input.
The Under Secretary for Food Safety and FSIS Administrator appear to want to develop a science-based policy regarding STEC. In this regard, it is important for all to approach the issue from the same perspective.
First and foremost, we need to recognize that non-O157 STEC are a health concern. There are those in industry that have already recognized this, but we all need to be on the same page. Putting aside for the moment issues such as attribution and severity, organisms that contain a Stx 1 or 2 (gene or toxin) and the attachment gene (eae) can cause illness.
In any discussion of STEC, it is important to remember that if a particular sample does not have a Stx gene or toxin, it is not an STEC by definition, regardless of the serogroup. Indeed, under the published FSIS method, the laboratory will report a sample as negative if there is no Stx. Moreover, according to the CDC, six non-O157 serogroups (O26, O45, O103, O111, O121, and O145) account for the majority of reported non-O157 STEC infections. Challenging whether these six non-O157 STEC are a health concern is contrary to the science and will definitely be counter-productive to working with the government on the appropriate regulatory framework.
Within the regulatory framework, questions such as severity and attribution are factors that can be considered within the risk profile. The regulatory framework should also take into account other virulence factors such as enterocyte effacement (LEE), whose genes are responsible for generation of attachment and effacement lesions. While not all STEC strains harbor the LEE, and it is not necessary to cause human infection, it is another example of the complexity of the STEC organisms.
In conclusion, we understand FSIS has completed a risk profile for non-O157 STEC and has solicited peer review of this document. Additionally, we understand that the agency intends to have both technical and public meetings, and conduct baseline surveys.
In short, it appears FSIS is attempting to proceed with a step-by-step approach based on science. We need to participate in the development of the regulatory framework on how to address these pathogens; not challenge the decision on whether to address them in the first instance.
Dennis R. Johnson is a principal with Olsson Frank Weeda Terman Bode Matz PC in Washington, D.C. Johnson has 30 years experience in food-safety law and regulation, representing large and small meat and poultry companies.
Getting it right with STEC
December 1, 2010