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Javier F. Flores is a partner with MG+M, whose trial and litigation practice focuses on food-borne illness, product liability, professional liability and premises liability matters. Javier has litigated cases throughout the country and has extensive experience defending and counseling clients in civil actions.

Raw Hamburger As we reported several weeks ago, there has been a media fueled public outcry against the inclusion of Pink Slime, which is otherwise known as, “lean finely textured beef,” or “LFTB,” in ground beef.  LFTB is comprised of the beef scraps which remain after the valuable cuts of meat are sold.  These pieces of meat are separated from fat through the use of a centrifuge, and treated with ammonium hydroxide to kill harmful bacteria. The result is a safe, edible, high quality beef product containing the same nutritional value as other ground beef.   In fact, the United States Department of Agriculture (USDA) continues to proclaim that both LFTB and the use of ammonium hydroxide to eliminate bacteria in meat are safe.

Despite the USDA’s continued support for LFTB, the social media led firestorm directed against LFTB has caused a significant backlash against the product.  For example, all but three states which participate in the National School Lunch Program (NSLP), which is administered by the USDA to provide low income school children with a free or reduced cost  lunch, now refuse to purchase ground beef which contains LFTB, despite the fact that it costs three percent less than the alternative. In addition, many restaurants, including McDonalds, and supermarket chains have followed suit and ceased the sale of ground beef which contains LFTB. As a result, many large beef producers have suffered large declines in revenue.  In fact, Beef Products, Inc. (“BPI”), the largest LFTB manufacturer, was forced to close three of its plants and lay off 650 employees.

In an effort to resuscitate their flagging businesses, many beef producers recently submitted requests to the USDA to add labels indicating the inclusion of LFTB. In response, the USDA instituted a voluntary labeling initiative, which many beef manufacturers have already put into practice.   In a further effort to increase transparency and dispute misinformation, BPI has also set up a website, www.beefisbeef.com, which provides valuable factual information about LFTB and the way it is produced.

The impact which the “Pink Slime” phenomenon has had upon the beef industry and the speed with which it developed are staggering.  The sale and consumption of LFTB had been widespread for more than thirty years, with USDA approval. Nevertheless, in a span of a few months, one of the country’s largest industries was derailed through the lightning fast spread of misinformation and misperception.   Perhaps, the lesson to be learned by the food industry is that transparency is the only way to prevent attacks such as those waged against LFTB.
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nanotechnologyNanotechnology is a cutting edge technology which involves the use of engineered, non-soluble material so tiny, it cannot be seen through a light microscope. Through manipulation of the chemical, physical and biological properties of nanomaterials, manufacturers can significantly alter the product into which they are added.   The potential capabilities of this technology in the food industry are endless. For instance, nanotechnology may be used in food packaging to keep products fresher and increase shelf life. Moreover, nano-based compounds can be used in food to enhance flavor or provide additional vitamins and minerals.

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance which addresses, among other things, the use of nanotechnology in food manufacturing and packaging materials. Though not legally binding, the draft guidance provides manufacturers with significant insight into the FDA’s current thinking on the use of nanomaterials in food products and packaging, as well as the direction in which the FDA may head in the future. The FDA makes it very clear as to its view on the potential risk such technologies present to both the consumer and food industry:

The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant.

USA Today News reported that based upon the draft guidance, it appears that the FDA will place increased scrutiny upon food products and packaging which utilize nanotechnology. The draft guidance provides criteria to be used by food manufacturers to determine whether changes to the manufacturing process, including the use of nanotechnology, are authorized under the food additive or color additive regulations. According to the draft guidance, changes which utilize nanotechnology would likely fall outside the purview of those regulations, and therefore would be subject to increased regulatory scrutiny.  A recent article written by Chicago Tribune reporter Anna Yukhananov, reported that companies which utilize engineered nanoparticles in the manufacture of a particular food or food packaging may be required to affirmatively demonstrate, through additional testing, that their product is safe before they can introduce the product into the market.  Further, that the food manufacturers which utilize nanotechnology are “encouraged” to make regulatory submissions to the FDA for its approval before marketing the product, a process which is not required before a company can sell products which use approved additives.

The FDA’s recent draft guidance suggests that it will be cautious and thorough in its oversight of nanotechnology.   The long-term impact of the use of engineered nanoparticles is largely unknown, and the FDA is scrambling to get ahead of the curve.  By imposing heightened regulatory requirements on companies who wish to utilize nanotechnology in their products, the FDA will transfer the responsibility and cost of assessing the safety of this new technology onto the food industry.  The FDA’s stance will likely result in a delay in the introduction into the marketplace of products which incorporate nanotechnology, as company’s assess whether the benefits outweigh the
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Raw HamburgerNever has the saying, “ignorance is bliss,” been more true than in the context of the ground beef filler known as “pink slime.”  Pink slime, which is known in the food industry as “lean finely textured beef,” or “LFTB,” has been a commonly used ingredient in ground beef for more than two decades.  It is made available to Americans as part of the ground beef they purchase at their local grocery stores and fast food restaurants, and it is fed to children in their school lunches.  Experts estimate that approximately 850 million pounds of LFTB are added to ground beef each year.  LFTB has been dubbed “pink slime,” based on its appearance.  But according to Rich Jochum, corporate administrator for Beef Products, Inc., which took out a full-page advertisement in The Wall Street Journal to defend its product,

“[t]he derogatory term [pink slime] has trumped all science, all facts, all history.”

In fact, LFTB is beef.  LFTB is comprised of beef scraps which are left over from the cow after the valuable cuts of beef are sold. A centrifuge is then used to remove the fat, and ammonium hydroxide gas is applied to kill bacteria.  The resultant product is then added as a filler to ground beef.  This allows meat processors to recover meat that might otherwise be wasted, and saves up to 1.5 million head of cattle from slaughter.  It also leads to leaner ground beef and lower beef prices for consumers.

Until recently, however, most Americans were completely unaware that the ground beef they consumed contained up to fifteen percent LFTB.  That is due to the fact that it is considered a raw material, and thus federal labeling requirements dictate that its inclusion need not be reflected on the label.  Both beef processors and the federal government regulators maintain that there was no reason to label the presence of LFTB in ground beef, and risk consumer confusion, because it is not a separate ingredient.  “It’s beef,” says a USDA official. “There are various parts of the animal that come together in ground beef.  This is just one part.” Moreover, The U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA) both deem LFTB safe for consumption.  They point to the fact that the product has never been linked to any outbreaks, nor have there been any safety related recalls.

That, however, did not stop the firestorm which quickly swept across this country, fueled by social media, over concerns about the use of ammonium hydroxide and the quality of the meat used in the filler.  The media attention, and the associated response of the American consumer, has led a number of supermarkets to phase out the sale of any ground beef which includes LFTB, and caused a number of school districts to indicate that they will no longer serve ground beef which contains LFTB. This, in turn, has led to an economic disaster for many meat processors, including AFA Foods Inc., which filed for
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Co-authored by Brian Gross 

Foodborne IllnessThe USDA has recently announced that it will delay implementation of a controversial new program to extend its Zero Tolerance Policy for E. coli 0157:H7 to include six additional E. coli serogroups:  O26; O45; O103; O111; O121; and O145, which the USDA declared adulterants in non-intact raw beef.  The new policy, which was to take effect on March 5, would require routine testing of raw beef for these six additional serogroups, and would prohibit any beef found to carry one of these pathogens from entering the food chain.

Although more than 700 serotypes of E. coli have been identified, very of few of those are foodborne pathogens.  In fact, only Shiga Toxin producing E. coli (STEC) serotypes are considered foodborne pathogens.  While there are but a few E. coli serotypes which are considered to be foodborne pathogens, theSTECserotypes are extremely virulent and require very little human exposure to cause infection.  The CDC estimates that there are approximately 265,000STECrelated illnesses each year, 64% of which are attributable to non-0157:H7 E. coli.

Compare that figure to the numbers 700 and 4, which is the reported amount of E. coli 0157:H7 related illnesses and deaths stemming from an outbreak traced to undercooked and contaminated meat served at a Jack in the Box on the west coast in 1993 and an expanded scope under the USDA’s policy make perfect sense.

The question remains however; despite heightened scrutiny, better processes and scientific advances why are we continuing to see a persistent increase in reported outbreaks and recalls related to E. coli? It seems counterintuitive. Dr. Marc Siegel, a senior contributor to the Fox News Channel’s Medical A Team offers up some valuable insights.

http://www.youtube.com/watch?v=T2Eqw_hZCi0

I couldn’t agree more with Dr. Siegel. Fear is one of the largest pathogens and unfortunately many attorneys are capitalizing on this symptom. Not only are we seeing a staggering increase in the number of reported E. coli illnesses, so too are the number of foodborne illness claims filed each year.

The result is that many good companies are now expending more resources then ever to defend foodborne illness claims, while at the same time working tirelessly to comply with a well intentioned, yet constantly evolving governmental mandate. As National Council for the one of the largest food service providers in the world, we’ve seen first hand how proactive compliance and best practices can have a significant impact in minimizing risk and exposure. Companies who truly care about their products embrace food safety because they understand that there is more at stake than the bottom line. Closely monitoring suppliers, using scalable HACCP Plans and implementing aggressive standards for quality control not only protect a company’s brand, but its customers. This makes it easier to withstand attacks from plaintiffs counsel so you can continue to put food on everyone’s table, including your shareholders.
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Co-authored by Brian Gross 

A company’s interest in protecting its brand by providing a safe product to consumers, in conjunction with the increased regulatory requirements set forth under the Food Safety Modernization Act (FSMA) require that entities active in the food supply chain take appropriate measures to verify that their suppliers comply with Current Good Manufacturing Practices (cGMPs).   It is incumbent upon every business involved in the food supply chain to perform its own due diligence with respect to its suppliers, including, confirming FDA registration, making Freedom of Information Act (FOIA) requests for documentation generated or retained during FDA inspections of suppliers’ facilities, reviewing suppliers’ Food Safety Control plans, Hazard Analysis and Critical Control Point (HACCP) plans and/or Allergen Control Programs, and conducting regular audits of their facilities.  Not every business, however, has the internal expertise to personally audit their suppliers’ facilities.  Furthermore, the current market demands, in which consumers expect local, organic foods, means that many businesses must purchase their products from a larger, more diverse group of suppliers.  This creates an issue because many businesses lack the resources to perform regular audits of all their suppliers’ facilities.  Companies cannot rely upon the FDA to audit their suppliers, as it lacks the funding necessary to audit food processing companies both domestic and abroad with the regularity necessary.   In fact, the FSMA only requires that the FDA inspect domestic high-risk facilities once by 2016, and at least every three years thereafter.  Third-party audits provide a cost-efficient alternative which, if properly regulated, can ensure a high quality of food without the insurmountable costs associated with having to individually audit each supplier.  For that reason, third-party audits will inevitably play a larger role in future food safety.

The failures of the third-party audit system are well documented.

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