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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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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.

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Shortly after 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 currently stand, no other non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) are considered adulterants in whole-intact and non-intact beef products.

In October 2009, however, Bill Marler (a national plaintiffs’ food lawyer) petitioned FSIS to issue an interpretive rule declaring all enterohemorrhagic (EHEC) Shiga toxin-producing serotypes of E. coli, including all non-O157 serotypes, to be adulterants in ground beef within the meaning of the Federal Meat Inspection Act. Click on the following link to view a copy of the Marler Clark Non-O157 STEC Petition.

According to Marler, there have been numerous food-borne illness outbreaks involving non-O157 STECs over the last 20 years which, in his view, justify a change in current FSIS policy. Despite the underlying implication that non-O157 STECs are and will continue to be a growing national problem, however, very few reported outbreaks have been associated with these pathogens in the United States.

Even FSIS agrees that outbreaks may be rare. At its 2007 non-O157 STEC Policy Meeting, FSIS noted that there have been only 13 outbreaks since 1990 associated with non-O157 STECs in the United States. Notably, of the 13 outbreaks that were reported, many were attributable to fresh produce, and none were associated with ground beef. Additionally, in 2005, CDC reported that there had been only 501 confirmed cases nationwide.  While these low numbers may ultimately be explained in part by limited testing, it may also be premature to conclude outright that non-O157 STECs are so predominant as to justify an overhaul of the current FSIS approach to pathogen testing and regulation.

FSIS agrees that available data is sparse and may not support a change at this point in FSIS policy. In its recent response to the pending petition, FSIS confirmed that “the agency cannot 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.” Click on the following link to view the FSIS Response to Marler Clark Petition.

Although FSIS plans to conduct additional research in this area, the agency concedes that, given the current limits of available data, it cannot effectively identify or even address the potential issues with these organisms. And, although additional research will eventually be completed, it remains to be seen whether the resulting findings will ultimately support the conclusion that non-O157 STECs are and should be treated as a significant and wide-spread public health concern in the United States.

In any event, based upon FSIS’ response, it does not appear that the agency will be taking any action on the petition soon. Thus, at least in the short-term, we will likely be left watching - with interest - as numerous scientists and public health officials continue to chew on this issue.

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The State of California recently enacted a new criminal law, effective January 1, 2009, designed to prevent slaughterhouses from purchasing and processing non-ambulatory animals for human consumption. As enacted, Section 599f amended the California Penal Code to criminalize, without exception, the receipt and use of non-ambulatory animals by slaughter facilities.

In response, the National Meat Association (“NMA”) sought and obtained a preliminary injunction to prevent the State of California from enforcing the new law. NMA, et al. v. Brown et. al, Case No. CV-F-08-1963 (E.D. Cal. 2008). In its briefs, NMA argued that the treatment of non-ambulatory animals was already regulated extensively by the Federal Meat Inspection Act (“FMIA”), which expressly permits, subject to certain requirements, the receipt and use of non-ambulatory animals for slaughter. Under the FMIA (21 U.S.C. § 601, et seq.) and its implementing regulations, non-ambulatory animals may be processed for human consumption if the animals are first inspected for disease and then passed by a federal veterinarian inspector. Because the California law attempted to criminalize what the FMIA permits, NMA argued persuasively that the California initiative was preempted.

Indeed, the FMIA (a distant relative of the 1906 Wholesome Meat Act) regulates virtually every aspect of meat production. The Act requires continuous federal inspection in meat packing plants, often times by multiple inspectors. These federal inspectors are responsible for ensuring that all animals entering slaughter facilities are healthy and free from disease, and that all meat products subsequently produced from such animals are safe, wholesome and not adulterated. Currently, the federal statutory and regulatory scheme is enforced by the Food Safety Inspection Service (a sub-agency of the United States Department of Agriculture).

To ensure that the FMIA and its uniform national requirements are not usurped by the individual states, the FMIA contains an express preemption provision which prevents states from enacting or enforcing any laws that are “different” from the federal standards. 21 U.S.C. § 678. Thus, under the FMIA, any state laws which attempt to penalize a food producer for doing what federal law permits (whether the laws relate to production or product labeling) are strictly preempted.

In this case, the new California criminal law conflicted directly with the federal statutory and regulatory scheme. Because the FMIA permits the use of non-ambulatory animals for slaughter (assuming such animals have been declared to be free from disease by a federal FSIS veterinarian inspector), the Court granted NMA’s request for a preliminary injunction. In its February 19, 2009 Decision, the Court reasoned that the California Penal Code, Section 599f, was both expressly and implicitly preempted under the FMIA and its implementing regulations.

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