Following the 1993 Jack in the Box outbreak, the Food Safety Inspection Service (“FSIS”) issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. Since this announcement, and as things are currently postured, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.
On May 27, 2010, however, Senator Kirsten Gillibrand (D-N.Y.) proposed new legislation aimed a classifying six additional strains of E. coli as adulterants under the Federal Meat Inspection Act (“FMIA”). Although the text of the proposed bill (S.3435) is not yet available, Sen. Gillibrand announced that, among other things, the legislation would:
- Define “E. Coli” to includ all “enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of Escherichia coli (E. coli)”;
- Specifically include as adulterants the following seven E. coli strains: O157: H7, 026, 045, 0103, 011, 0121, 0145; and
- Require the USDA and beef manufacturers to test product for all seven strains, and dispose of product in which any of the strains are found.
This bill comes on the heels of the Senator’s April 22, 2010 letter to USDA Secretary Tom Vilsack urging the USDA to begin testing for and regulating the additional E. coli strains. And, as we reported previously, Bill Marler (a national plaintiffs’ food lawyer) also petitioned FSIS in October 2009 for an interpretive rule declaring all non-O157 STECs to be adulterants in ground beef.
The FSIS has since announced, however, that it could not “reach a decision about the substance of the petition until it has developed additional laboratory capacity to detect and isolate various non-O157 STEC groups.”
At a 2007 meeting regarding non-O157 STECs, the FSIS noted that since 1990 there were only an handful outbreaks associated with non-O157 STECs in the United States, and none of them were associated with ground beef. This fact, coupled with a lack of data regarding the prevalence of non-O157 STECs in beef products, has prompted the FSIS to examine the feasibility of more thorough research and testing prior to adopting the significant policy changes sought by Mr. Marler and Sen. Gillibrand.
Additionally, at least some questions still remain about the virulence of non-O157 STECs that may in rare instances find their way into beef products. Not all of the strains, even when present in beef (as opposed to other food products), may be able to produce the specific toxins or combinations of toxins necessary to cause the severity of illness sometimes associated with E. coli O157:H7. Here too, knowledgeable experts concede that more research is likely needed.
Finally, according to the American Meat Institute (“AMI”), there is no test currently available to easily detect the six strains included in the bill. Thus, in addition to needing additional research to quantify the prevalence and virulence of these additional strains in beef, additional efforts would likely be needed to ensure not only that an effective test is readily available, but that the test could be easily obtained and quickly administered.
Even with this said, however, experts at USDA have already confirmed that existing food safety interventions already in place work equally well to combat both O157 and non-O157 STECS. And, AMI recently echoed these comments, noting further that, because “food safety resources in the private sector and the public sector are not infinite, it's important to invest in [new] technologies that will provide meaningful food safety benefits." Thus, whether such resources should ultimately be devoted toward the development and implementation of additional interventions to actually combat pathogens, or whether government and industry should instead invest in “additional testing,” will likely depend upon the results and findings of future research.
Sen. Gillibrand is also sponsoring two other pieces of legislation related to food safety. She authored the E. Coli Eradication Act of 2009 (S.2792), which would require additional tests for E. coli O157:H7 in beef facilities, and is also a co-sponsor of the FDA Food Safety Modernization Act, which will likely pass later this year.
Sen. Gillibrand is a member of the Senate Agriculture Committee. She was appointed to the U.S. Senate in January 2009 to fill Secretary of State Hillary Clinton's seat and is a candidate for the seat in the upcoming November 2010 election.
We will, of course, continue to monitor the non-O157 STEC issue, as well as other pending food safety legislation, and will keep you apprised of any new developments.