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

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.

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

It’s been extremely fulfilling to host defendingfoodsafety since our launch a little over  a year ago.

To date, we’ve welcomed over 100,000 visitors, received incredible feedback, and (I hope) helped you better protect your company from foodborne illness outbreaks and litigation.

And today, I'm proud to announce that we're launching the latest food safety blog at Meatingplace – Legally Speaking. Here’s the breaking news from Meatingplace:

By Rita Jane Gabbett on 8/5/2010

Attorney Shawn Stevens will join the Meatingplace faculty of industry experts on Aug. 5 with the launch of his “Legally Speaking” blog.

Stevens defends and counsels clients nationwide in high-profile foodborne illness outbreaks and lawsuits. He is an equity member of the Milwaukee law firm Gass Weber Mullins LLC.

During the past decade, Stevens has managed and defended hundreds of food-borne illness claims. Clients have included some of the nation’s largest beef producers, national restaurant chains and several food distributors and grocers.

Cases have involved outbreaks and claims involving E. coli O157:H7, Campylobacter, Clostridium Perfringens, Norovirus, Salmonella and Staphylococcus. Stevens also assists clients with risk avoidance, crisis management and other issues in advance of and following major food product recalls.

“Far beyond any other topic, food safety is the leading concern for our audience. One lawsuit or mishandled recall can shutter a plant forever,” said Bill McDowell, editorial director for Meatingplace and its sister publications. “Shawn Stevens' legal perspective is a perfect complement to the tactical and regulatory commentary of our other food safety contributors, Dr. James Marsden and Dr. Richard Raymond.”

Stevens also speaks regularly to national audiences on topics relating to the defense of foodborne illness outbreaks and claims . . .

So, thanks for keeping up with us on defendingfoodsafety.com. And, now, be sure to check us out on Meatingplace. You might even enjoy my first post:

Despite Best Efforts, Both Pathogens and Lawyers Remain Difficult to Eliminate.

For better or worse, we’ll be around for awhile.

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

As I cruise back to Milwaukee at nearly 40,000 feet, reflecting quietly upon the last few days, I know there are certain experiences in life I will never forget. 

One of these was the International Association for Food Protection (IAFP) annual meeting in Anaheim. The venue was outstanding, the program was phenomenal, and the company was no less than amazing. In addition to seeing many old colleagues, I had the distinct pleasure of meeting numerous new friends, whose views, perspectives and shared experiences have already changed my life. For that, I thank them.

I also had the distinct pleasure of seeing Mike Taylor and listening to his comments during the conference regarding recent FDA accomplishments and new initiatives.  

Taylor remains hopeful that the Food Safety Modernization Act will pass the Senate this year. He also discussed at length the recognized and significant challenges the agency faces as it works to develop and implement new food safety produce rules. These challenges are driven in large part by the expansive diversity in products, as well as significant diversity in growing regions, climates, operations, practices and markets. These challenges, of course, increase when contrasted against the goal that any new rules be risk-based, scalable and appropriate.

During his comments, Taylor also noted appropriately that “most of the actions that determine whether or not food is safe are not governmental actions; rather, it’s the work of everyone in the farm to fork continuum.” As explained by Taylor, this includes the critical food handling practices at the consumer level. 

Conceding that FDA cannot “regulate consumers,” however, Taylor recognized that we need a new food safety educational initiative that “treats consumer behavior as seriously as it is.” In this regard, Taylor promised additional research as the agency works to determine how to best “change consumer behavior. “ Put simply, Taylor agreed that “food gets safer when everybody in the food system does their job.”

The remainder of the conference, as noted, was tremendously substantive and informative. And, it was humbling to be surrounded by the superstars of food safety.  In each and every way, the IAFP staff and their countless volunteers should be thanked for putting together a world-class event. 

And, as you can imagine, we are extremely excited for 2011, when the conference follows us home – for its 100^th Year Anniversary – to Milwaukee.

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

On March 14, 2009, President Obama announced the creation of the Food Safety Working Group. The group is currently chaired by Secretary of Health and Human Services Kathleen Sebelius and Secretary of Agriculture Tom Vilsack.

Appearing after the PCA peanut butter outbreak and recall, the Working Group was formed in response to an increasing number of foodborne illness outbreaks in recent years, and was tasked with the responsibility of recommending changes to food safety regulations, fostering better coordination between federal agencies, and ensuring the enhanced enforcement of numerous food safety laws.

In May 2009, the Working Group launched its website (foodsafetyworkinggroup.gov) and held a public “listening day” to solicit input from federal and state health officials, food industry, consumers and others. Then, four months following its creation, the Working Group announced its three core principles: (1) working to prevent harm to consumers as a first priority; (2) recognizing that effective food safety inspections and enforcement depend upon good data and analysis; (3) committing to quickly identify and stop foodborne illness outbreaks.

To facilitate these goals, the Working has Group assisted, in varying degrees, with the development of numerous food safety issues in the past year. Below are just a few of the initiatives recently encouraged and embraced by the group:

• FDA’s new rules to combat Salmonella contamination in eggs.

• FDA request for comments on proposed guidance to reduce microbial contamination of tomatoes, melons and leafy greens.

• USDA's new initiatives aimed at testing bench trim for E. coli O157:H7 and the issuance of draft guidelines on methods for controlling E. coli O157:H7 on the farm.

• The enhancement of www.FoodSafety.gov and content for consumers.

• The opening of the Commercial Targeting and Analysis Center to better ensure the safety of imported foods.

• FDA’s activation of the Reportable Food Registry designed to more quickly identify and track adulterated food products.

• The decisions by FSIS, FDA, and CDC to host joint food safety meetings for input and collaboration on performance measures for food safety.

• The recent decisions by USDA and FDA to conduct additional public meetings regarding product tracing and tracing source materials for E. coli O157:H7 in beef.

These, of course, represent many significant food safety initiatives made possible by substantial governmental and industry collaboration.  So, although the President announced during the creation of the Working Group that “[t]here are certain things [such as ensuring safe food] that only a government can do,"  we would simply note that his statements only paint a partial picture.

Let there be no mistake, Americans do enjoy one of the safest food supplies in the world in part because of continued governmental oversight. But, it is also important to note that American consumers enjoy one of the safest food supplies in the world in a much larger part because of the efforts of the hard-working Americans who actually feed our families. Thus, while government can regulate industry, only industry and its individual members can safety and successfully feed a nation.

So, is the Working Group still working? Of course. But, let us not forget that so are you. Thus, once again, we would like to say "thank you" to all those who work tirelessly, each and every day, to provide safe food for each of us and our families.

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