Defending Food Safety : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

There are endless numbers and statistics thrown around each day by the government, industry and consumers, along with different interpretations and explanations for each.

The CDC recently announced, for instance, that food-borne disease outbreaks and food-borne illnesses dropped by 8 and 15 percent, respectively, in 2007. Although we would like to believe that the reduction is a sign that food safety is headed in the right direction, the CDC has theorized that the decline is due to an increase in immunity to norovirus.

In turn, legislators are calling on the USDA and beef manufacturers to begin testing product for six non-O157 STEC strains. As one justification, rule makers point to the CDC’s estimate that that non-O157 STECs cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths each year. However, legislators fail to mention one key statistic: very few non-O157 STEC outbreaks have been caused by ground beef.

Although numbers and statistics are not always clear cut, and are subject to interpretation, they are increasingly shaping FDA and FSIS policy making.

On March 30, 2010, CDC, FDA and FSIS (the “Agencies”) jointly held their first public workshop on “Measuring Progress on Food Safety: Current Status and Future Directions". The Agencies’ hope to identify the best metrics to better quantify the true incidence of food-borne illness and which pathogens and foods are most at fault. In turn, they plan to use those measurements to directly gauge which policy changes are lowering the incidence of food-borne illness.

Further, the Agencies want to identify the best metrics to monitor food safety at each step in the farm to fork continuum. The FSIS, in its Federal Register Notice, put forth these queries to the industry:

• What metrics do industry members have in place to assess whether suppliers meet purchase specifications that address food safety?
• What metrics do industry members have in place to assess the safety of the finished products?
• What metrics do industry members employ to evaluate the effectiveness of their food safety systems?
• Has industry found some metrics that have been particularly effective in evaluating food safety?
• Are there other metrics that industry has found to be inadequate for measuring food safety?

The Agencies held another public meeting regarding “Measuring Progress” in July and will be holding a final public meeting on October 20, 2010 in Portland.

At this final meeting, industry (and state regulators and consumer groups) are encouraged to make presentations on metrics. The Agencies will also provide updated information about their current thinking on the use of metrics to measure food safety.

Since numbers and statistics can be so ambiguous, it is imperative that industry shares their knowledge of which metrics work – and which do not. The Agencies are looking to tie numbers to their policies. Since we are all strive to lower the incidence of food-borne illness, let’s make sure that meaningful statistics encourage constructive regulations.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

At a recent conference focused on the prevention of E. coli, the USDA came prepared to comment on its current thinking relating to new and emerging policy initiatives. In turn, Dan Engeljohn (Deputy Assistant Administrator of the FSIS Office of Policy and Program Development) offered a number of pointed observations.

In cases involving a further processor which commingles raw materials from multiple suppliers, it can sometimes be difficult to trace the source of a subsequent outbreak to a single supplier. As a result, Engeljohn explained that the USDA is currently analyzing the merits of using the internal microbiological testing data generated by a further processor of product testing positive for pathogens to help the agency trace the pathogen back to the originating slaughter facility.

With respect to slaughter facilities themselves, Engeljohn also announced that the USDA may issue criteria for assessing prudent "high event day determinations.” Although the USDA concedes that 100 percent testing at any large slaughter operation would likely produce at least some positives during any given day of production, Engeljohn noted further that a large number of positives in a short period of time could potentially be a red flag.

Engeljohn also confirmed that the USDA is continuing its work on validating the methodology for testing and identifying non-O157 Shiga Toxin-Producing E. coli (STECS), from six serogroups (O26, O103, O111, O121, O45 and O145), in FSIS samples. Once sufficient baseline data can be collected and assessed, the agency will likely make a determination whether to classify any of these pathogens as adulterants in raw ground product. In addition, although whole-intact cuts of beef containing E. coli O157:H7 are not considered adulterated under current law, Engeljohn suggested that USDA is continuing to consider whether it may someday modify this standard.

Moving forward, we will, of course, continue to report on new and emerging developments.

• Email This
• Print
• Comments
• Trackbacks
• Share Link