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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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