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

After years of deliberation, USDA has formally declared six additional pathogenic E. coli serogroups (O26, O45, O103, O111, O121 and O145) to be adulterants in non-intact raw beef.

From this point forward, any raw ground beef or tenderized steaks found to contain these pathogens will be prohibited from sale to consumers.

While some within the beef industry reacted warmly to the news, others where not so receptive. In a September 13^th, press release, AMI Executive Vice President James H. Hodges criticized the foundation of the new policy:

“This new policy is not supported by science and likely will not benefit public health.  Indeed, in the policy notice USDA acknowledged that ‘we do not know how many illnesses will actually be prevented.  It is not clear whether or not there will be a reduction in the number of illnesses.  It is also challenging to know what the industry cost will be because it is difficult to predict how many establishments will start to test and what the size distribution will be or to what extent industry will take additional measures that will prevent, reduce, or control those hazards, as they do with regard to O157 STEC.”  

Indeed, in many ways, the issue has given way to more questions than answers. Processors, especially small ones, are asking how they will be able to adapt to the likely array of new testing requirements and protocols which may soon be be expected of industry. Moreover, as of today, the time needed to carryout the tests has been causing significant problems for those companies which are already testing.

“It can be a cumbersome process,” Craig Letch, director of quality assurance for Beef Products Inc., told Meatingplace. Letch said that while testing for E. coli O157:H7 can hold up a product shipment for days, there have been times when products being tested for the new strains have been held for even longer, “if in fact you have reactivity.”

Many companies, especially those dealing in fresh products, simply do not have the space or capacity to hold their products for nearly a week before shipment. The added expense of not just testing, but then instituting new programs and holding product for extended periods of time, could significantly and adversely affect both industry and consumers alike.

I have always been the first to commend USDA for demonstrating a real commitment to food safety. In the absence of any real studies supporting this decision, however, the policy appears to have been driven more by sensationalism than by science. 

While it may feel good to declare a bug an adulterant, there is little to show, at this point, that it will have any effect on making our food safer.

I sincerely hope that I am proven wrong.

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

The Food Safety and Inspection Service (FSIS) may be one step closer to taking a substantive stance regarding the non-O157 STEC issue. Recent statements made by the FSIS describe the agency’s progress, and hint at additional regulation.

In October 2009, Bill Marler (a national plaintiffs’ food lawyer) submitted an interpretive rule petition to the FSIS requesting that all non-O157 Shiga toxin producing E. coli (“non-O157 STECs”) be declared adulterants in ground beef. In response to the petition, FSIS stated that when it had an appropriate laboratory method for conducting regulatory sampling for non-O157 STECs, and had developed a plan for how it intended to address the issue, it would make the plan available to the public for comment and would, at the same time, issue a final response to the petition.

Two months ago, Dr. Elisabeth Hagen, Under Secretary for Food Safety, touched on the non-O157 STEC issue at the 2010 National Food Policy Conference and in a statement to the New York Times. Dr. Hagen said that FSIS policies “need to evolve to address a broader range of pathogens, beyond E. coli O157:H7.” She queried how we best protect consumers from pathogens that are not addressed by current policies.

A few weeks ago at the North American Meat Processors (NAMP) annual conference, Dr. Dan Engeljohn revealed that FSIS is “very close to having a [test] methodology for all six” non-O157 STECs. Dr. Engeljohn is the FSIS’s chief policy writer. He reiterated the steps which FSIS will take following completion of the test methodology – a Federal Register notice will outline an enforcement strategy, followed by public meetings and comment, and the issuance of guidance.

While FSIS action is on the horizon, we of course urge the agency to consider carefully the American Meat Institute’s recommendations on non-O157 STECs, summarized as follows:

1. Focus on Prevention
2. Conduct a Comprehensive Public Health Risk Assessment
3. Validate Analytical Laboratory Test Methods
4. Conduct a Baseline Survey of Non-O157:H7 STECs on Beef Products
5. Measure Progress Based on the Public Health Outcome
6. Expedite Approval of New Microbial Interventions
7. Determine Impact on International Trade
8. Provide an Open and Transparent Public Policy Process

A focus on prevention should remain the number one priority. The AMI said it well: Making a pathogen illegal through a policy change will not prevent this pathogen from occurring. Making non-O157:H7 STECs illegal could also divert scarce resources away from enhancing food safety prevention efforts. Click on the following link to view the AMI’s Position on non-O157:H7 STECs.

As noted, a rush to implement test and hold programs for non-O157 STECs could potentially distract from research into even better interventions that prevent O157 and non-O157 contamination alike. The industry’s resistance to additional testing, however, is poorly perceived by consumers because the general public fails to realize the incredible shortcomings of testing. Safer food flows from preventing contamination in the first instance, rather than searching for a needle in a haystack.

And, lest consumers believe that industry is only concerned about the bottom line, I will take this opportunity to commend our food manufacturers on the incredible effort and investment which has greatly improved food safety in the past 15 years. Dr. Engeljohn specifically applauded the beef industry at the NAMP conference. The AMI Foundation alone has millions of dollars in grants towards developing new food safety technologies, and major industry manufacturers have spent billions on food safety improvements.

Hopefully, FSIS respectfully considers the industry’s perspective on non-O157 STECs. We, of course, will continue to follow this issue closely.

• 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

Walmart and Sam’s Club have announced that they will impose enhanced food safety measures on their beef suppliers.

According to the company, the new mandates are designed to reduce to the greatest extent possible the risk of potential contamination by pathogens such as E. coli O157:H7 and Salmonella. Click on the the following link to view Walmart’s Beef Safety Press Release.

Under the new standards, beef processing (grinding) facilities which supply the company will be required to provide validated evidence within the next year that their process controls can achieve a 2-log reduction of pathogenic microorganisms. By June 2011, slaughter facilities supplying the company will be required to demonstrate a 3-log reduction. In turn, Walmart has also mandated that, by June 2012, slaughter facilities must go even further and validate a cumulative 5-log reduction.

Dr. James Marsden, a food safety scientist, stated that “Walmart has taken steps to provide its customers with the safest possible beef products. Consumers across the United States will benefit greatly from this timely food safety initiative.” Given the breadth of Walmart’s influence, Dr. Marsden’s comment cannot be underscored enough. More than 200 million people shop at the 4,300 Walmart stores throughout the nation.

Walmart’s imposition of more stringent standards does not mean, however, that most manufacturers are not already doing virtually everything they can to produce safe and wholesome food. Tyson, a major Walmart beef supplier, believes that its food safety measures are already in line with the new protocol. Thus, for many suppliers, meeting Walmart’s expectations will likely only entail producing microbiological testing data to verify that those interventions already in place are effective. With that said, however, most also agree that any new requirements set by the retail giant can only push those manufacturers not already reaching a very high standard to strive even harder.

Of note, Walmart excluded irradiation as an approved intervention for its beef. Although irradiation can safely destroy pathogens in ground beef, some types can slightly affect beef quality and many consumers are still leery of the concept. Nevertheless, as we reported previously, the technology is improving and hopefully someday, with additional research and consumer education, it will be a viable alternative for all foods.

In any event, while researches and industry continue to seek new interventions that may someday effectively eliminate pathogens in ground beef, Walmart’s new requirements appear to be yet another step in the right direction as we all strive to make the food we eat as safe as possible.

• 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

Following recent media coverage involving the regulation of our food supply, Agriculture Secretary Tom Vilsack issued a statement highlighting the continuing efforts of USDA to ensure that our food remains as safe as it can be. Click on the following link to view the USDA Statement.

“Over the last eight months since President Obama took office,” said Vilsack, “the USDA has been aggressive in its efforts to improve food safety, and has been an active partner in establishing and contributing to President Obama's Food Safety Working Group.”

"Protecting public health is the sole mission of the USDA Food Safety and Inspection Service. FSIS has continued to make improvements to reduce the presence of E. coli O157:H7 and the agency is committed to working to reduce the incidence of food-borne illnesses caused by this pathogen.

"Shortly after coming into office, the Administration created a high-level Food Safety Working Group to coordinate food safety policies, focus greater resources on prevention, and improve response to outbreaks. Since doing so, we have taken the following actions:

• Launched an initiative to cut down E. Coli contamination (including in particular contamination from E. Coli O157:H7) and as part of that initiative, stepped-up meat facility inspections involving greater use of sampling to monitor the products going into ground beef;

• Appointed a chief medical officer within USDA's Food Safety Inspection Service to reaffirm its role as a public health agency;

• Issued draft guidelines for industry to further reduce the risk of O157 contamination;

• Started testing additional components of ground beef, including bench trim, and issuing new instructions to our employees asking that they verify that plants follow sanitary practices in processing beef carcasses; and

• Designed the Public Health Information System (PHIS) in response to lessons learned in past outbreaks.

According to Vilsack, "the USDA is also looking at ways to enhance trace back methods and will initiate a rulemaking in the near future to require all grinders, including establishments and retail stores, to keep accurate records of the sources of each lot of ground beef."

"No priority is greater to me than food safety," said Vilsack, "and I am firmly committed to taking the steps necessary to reduce the incidence of food-borne illness and protect the American people from preventable illnesses. We will continue to make improvements to reduce the presence of E. coli 0157:H7."

Because there is no technology (with the exception of irradiation or cooking), however, to ensure that raw animal products can be made sterile, FSIS continues to remind consumers that thoroughly cooking raw animal products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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

Health officials throughout the country are investigating a new Salmonella outbreak which has potentially sickened dozens nationwide.

According to the Colorado Department      of Public Health and Environment ("CDPHE"), the outbreak involves an antibiotic-resistant strain of Salmonella Newport. In Colorado, at least 21 people have been sickened in 10 counties, and four of the victims have been hospitalized. Although no conclusions have been issued regarding the source of the outbreak, preliminary indications suggest that the outbreak could potentially be associated with the consumption of undercooked ground beef. Click on the following link to view a copy of the CDPHE News Release.

According to the CDPHE, eight other states have reported cases that are related to the ongoing outbreak. The USDA, CDC and numerous state health agencies are cooperating in the ongoing investigation.

Although the Colorado news release did not specifically identify the other states involved in the investigation, one of them, reportedly, could be Maine.  On July 31st, the Maine Center for Disease Control and Prevention alerted health care providers and lab directors throughout the state to an outbreak of salmonellosis due to "an unusual type of Salmonella." Six cases have been confirmed in three counties. At least two of the isolates recovered from patients in this outbreak are resistant to the antibiotic ampicillin. Click on the following link to view a copy of the Maine News Release.

All of the Colorado and Maine outbreak cases developed in late June and early July.

The CDPHE, of course, is reminding consumers and food handlers to handle ground beef properly to avoid cross contamination, and to cook ground beef thoroughly. The FSIS likewise reminds consumers that thoroughly cooking raw beef products to an internal temperature of 165 degrees will destroy any pathogens that may be present, and will render the products safe.

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