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

With the passage of the Food Safety Modernization Act (FSMA), FDA has been tasked to cultivate approximately 50 new rules, guidance documents, reports and studies – all of which all must be implemented within very specific timeframes.

In turn, while many of the new provisions have yet to be implemented, numerous milestones (despite popular belief) have already been met. These milestones have also, at least in part, touched upon many of the most significant changes under the new law, including increased agency authority, new requirements for preventative controls and new import standards and expectations. Although many of these topics (along with additional anticipated developments still lurking just over the horizon) will be discussed in greater detail in our next issue, we wanted to provide a quick primer of both where we’ve been and how much further we still need to go.

Notably, FDA’s implementation of the FSMA first started gaining real momentum three months after passage (in March 2011), when FDA hosted a public meeting focused on the legislation’s new import safety requirements. The meeting attracted more than 500 attendees and, although many topics were discussed, the debate focused mainly on four key import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; the Voluntary Qualified Importer Program; and the Foreign Supplier Verification Program. In essence, these new initiatives will require food product importers to ensure that each of their foreign suppliers are following the same standards that are and will be expected of food processors here in the U.S.

It became clear from the meeting, however, that setting such standards, and then ensuring compliance, will create significant challenges. The amount of food that is imported into the United States has been steadily and rapidly increasing for years. This is especially true with high risk foods like fruits, vegetables and seafood. In turn, much of the food imported annually originates from countries (and economies) without the resources or infrastructure to develop and implement the robust food safety programs which are taken for granted here in the United States.

Nevertheless, the FDA has announced that it will expect those U.S. food companies who chose to import, process or sell foreign products to ensure not only the safety of the products themselves, but to also ensure that their foreign suppliers are complying with each of the regulatory requirements under the FSMA. These requirements, for instance, will mandate that each foreign supplier implement a written food safety plan that satisfies the requirements of FDA.

In the weeks following the March 2011 import safety meeting, FDA then began focusing additional effort on widening it regulatory powers here at home. On May 5, 2011, FDA issued a new rule allowing it to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The new rule went into effect on July 2, 2011.

Effective the following day, on July 3, 2011, the FDA then gave itself additional authority, which allows the agency to suspend the registration of regulated U.S. food facilities. This new power gives FDA the ability to suspend (or threaten to suspend) the registration of any regulated food facility if the facility is producing food which, in the judgment of the agency, presents a reasonable probability of causing serious adverse health consequences or death.

Since July, the agency has been moving forward on other fronts as well. With the assistance of the Department of Health and Human Services (HHS), FDA has also begun to develop and implement a joint-anti smuggling strategy to identify and prevent smuggled foods from reaching the United States. HHS and FDA report that they will be partnering with the Department of Homeland Security and the U.S. Customs and Border Patrol to implement multi-phase strategies and technologies to counter existing and emerging smuggling threats. The threat of smuggled food, of course, extends all the way from consumer safety to national security and terrorism.

And, as many of you know, the FDA was also accepting public comment – through last August – on the docket for “Preventive Controls for Registered Human Food and Animal Food/Feed Facilities.” According to FDA, the comments received will be used by the agency to help shape the new regulations which will mandate that all regulated food facilities implement written food safety plans no later than July 2012. While many industry groups have taken advantage of the opportunity to share their perspectives with FDA, substantial uncertainty continues to exist with regard to not only what the new standards will specifically say, but how they will be uniformly and fairly enforced across the vast array of differing food processing operations across the country.

In this regard, despite the agency’ progress on many fronts, virtually all regulated food companies continue to wonder what is going to be asked of them and when. Although we have talked generally in previous articles about approaching deadlines and anticipated expectations, it will remain difficult for any food company to effectively prepare for the new anticipated regulatory changes until FDA actually publishes the new requirements.

Additionally, in the absence of any clear direction yet from FDA regarding what, specifically, the new regulations with say, many small and medium-sized companies remain worried about their long-term survival. Given the unprecedented increase in new FDA regulation triggered under the FSMA, many small businesses (some already struggling as a result of the lethargic economy) are fearful that the investments which will be required to ensure compliance could ultimately impact their ability to compete and potentially lead to financial collapse.

Indeed, Kathy Means, Vice President of Government Relations and Public Affairs at the Produce Manufacturer’s Association, recently echoed such fears, warning that while “[e]very business must have a food safety plan, these plans should be adaptable and not burdensome to small businesses.” After all, Means concluded, “the reality is that pathogens simply do not respect the size or type of an operation.” Thus, we remain hopeful that the public comments already received by FDA from industry and key stakeholders will lead to practical standards which all companies can both efficiently and effectively implement to improve their food safety programs.

In spite of the progress already made by FDA, the implementation of effective regulations (whatever their form) remains a significant challenge. In addition to the difficulties associated with developing a single set of clear and effective standards, FDA will need significant additional funding to properly, uniformly and fairly enforce those standards. Already, FDA has expressed frustration over the contrast between Congressional expectations and the limited funding which may ultimately be allocated. The agriculture appropriations bill recently passed by the House of Representatives, for instance, would decrease funding to the FDA next year by $87 million.

With that said, the FDA, seems to recognize the breadth of changes it faces, and now has more than two dozen separate working groups focused on implementing the FSMA. And, at the end of the day, we remain confident that FDA is doing all it can, and trying to do it well.

As with any piece of monumental legislation, especially one which directly affects every consumer in our nation, FDA has wisely solicited assistance directly from the food industry in a sincere effort to make the coming changes workable for all.

In the meantime, as we are driven by FDA further down this new regulatory path, we simply hope the continuing journey remains as smooth and bump-free as possible.
 

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If there’s any doubt that the legal profession will continue to significantly impact the way we do business, I wanted to share some additional perspective. When conditions are ripe, lawyers (like pathogens) tend to multiply quickly.

Most of us recall the large west coast E. coli O157:H7 outbreak in the early 1990s, in which nearly 600 people fell ill and some lost their lives. At that time, there were few reported outbreaks, very few food safety attorneys and hardly any foodborne illness lawsuits.

Since then, we have witnessed stunning changes within the industry. Beginning in 1994, USDA required raw meat products to carry safe-handling labels. In turn, Mike Espy issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. In 1998, USDA solidified its zero tolerance standards (for fecal and ingesta), and required establishments to implement comprehensive HACCP plans.

Meanwhile, enhanced surveillance increased our ability to detect food-borne illnesses nationwide. The CDC created PulseNet so public health agencies could upload and compare the PFGE (DNA) patterns of pathogens isolated from ill persons nationally. From 195 PFGE patterns in the mid-1990s, the database has grown to nearly 400,000 today. Having access to such information has helped investigators determine: (1) whether reported food-borne illness cases are genetically similar; and (2) whether they may have originated from a common source.

This, of course, has also led to a recent increase in reported outbreaks and recalls. Rarely a day goes by when we don’t hear about food safety in the news. And, with increased media coverage and public awareness, many attorneys have taken notice.

While a Google search for “slip and fall attorney” yields about 125,000 returns, “food poisoning lawyer” garners nearly 500,000. The result is an ever increasing number of lawsuits, often without merit, pursued by lawyers with little or no knowledge of food safety.

Because of increasing scrutiny from regulators, the media and lawyers, fewer mistakes are also avoiding detection. Thus, we should do all we can to reduce our risk and exposure to the greatest extent possible. We should embrace a robust food safety culture, closely monitor our suppliers, continuously refine our HACCP Plans, and aggressively ensure incoming and outgoing product has been appropriately tested. We are, after all, members of an incredible industry that works tirelessly to provide our families with the safest food possible.

So, recognizing that plaintiffs’ attorneys have to eat too, we should each do our part to ensure they’re shopping for our products – and not our customers.

 

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There has been a lot of attention drawn to recent salmonella and listeria outbreaks, and, in turn, those pathogens themselves. In the meantime, the pathogen Campylobacter has worked itself into relative obscurity. This may seem surprising, as CDC estimates that Campylobacter associated illnesses affect as many as 845,000 Americans each year.

Campylobacter is a spiral-shaped bacteria that causes disease (Campylobacteriosis) in both humans and animals and is often found in the intestinal tracts of poultry, cattle, swine, domestic animals, and sometimes humans. The bacteria pass through feces and can also be found in untreated water. It is the leading cause of diarrheal illness in the United States (USDA).

Symptoms of infection due to the bacteria usually occur 2 to 5 days after consuming contaminated food, however, it may take as long as 10 days for symptoms to appear. This is similar to E. coli and the two are often confused for one another. The most common symptom is diarrhea which can often times be bloody. Other symptoms include fever, nausea, abdominal pain, headache, vomiting, and muscle pain. Like most FBIs, those most susceptible to contracting Campylobacteriosis are young children, elderly persons, and pregnant women.

In most instances, campylobacter infections resolve without serious illness occurring. It is important to note, however that even though complications from Campylobacter infections are rare, they can occur. The following are the most common:

• Gullian-Barre´ Syndrome (GBS): most common cause of generalized paralysis. GBS occurs when antibodies built up to fight the disease attack nerve cells.

• Reactive Arthritis: inflammation of the joints, eyes, reproductive or urinary organs.

• Appendicitis

In the event that a widespread outbreak was to occur, even statistically insignificant numbers of individuals affected by such complications could spell disaster for a company. The resulting lawsuits could easily result in millions of dollars in settlements and significant brand damage.

As with preventing all foodborne illnesses, maintaining sanitary conditions and remaining cognizant of potential hazards can make all the difference in preventing Campylobacter outbreaks. With continued awareness of harmful bacteria such as Campylobacter, and how we can prevent it from occurring in our food, we can continue to prevent serious foodborne illnesses from affecting our families and ourselves.
 

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The FDA recently announced the implementation of a fully-staffed network dedicated to rapidly responding to human and animal foodborne illness outbreaks. This group is called the Coordinated Outbreak Response and Evaluation (CORE) Network.

Kathleen F. Gensheimer, formally Maine’s state epidemiologist, will lead CORE, in the new position of Chief Medical Officer/Outbreak Director. Under the leadership of Gensheimer and the FDA, CORE will be staffed by epidemiologists, veterinarians, microbiologists, environmental health specialists and risk communications specialists.

Their primary objectives of the new group are to: (1) rapidly respond to emerging outbreaks; and (2) research past outbreaks in order to develop new preventative methods in the hopes of mitigating or preventing future outbreaks.

Gensheimer, quoted in the FDA’s press release, stated, “A real benefit of the network approach is enhancing communication and coordination with federal, state and local food safety agencies, as well as industry and consumers. Given my background at the state public health level, this is a major priority for me.”

Before CORE was created, there was no centralized staff, but rather various offices of the FDA that responded to incidents. CORE, FDA is hopeful, will provide a more in-depth process of monitoring and evaluating foodborne illness outbreaks as well as facilitating faster responses when outbreaks do occur.

The lack of coordination between the multiple governmental agencies involved in foodborne illness outbreaks has, historically, resulted in a host of problems. In some instances, these have included errors in trace back investigations conducted by local health department personnel which have prevented the true source of an outbreak from being identified.

The FDA confirms that CORE will work closely in all outbreak investigations with the Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), as well as public health and agriculture agencies.

“The centralized staff of the CORE Network will work closely with FDA’s field emergency response coordinators and the investigative and analytical teams in the District offices and associated laboratories,” said Dara Corrigan, associate commissioner for regulatory affairs. “Working together will help to both standardize and strengthen how we conduct foodborne outbreak activities in the field.”

Ideally, CORE will fundamentally change the manner in which foodborne illness investigations are conducted in a way that allows for faster resolutions, more effective trace back and most importantly, fewer illness.
 

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With the passage of any new legislation, there is bound to be a period of lengthy adjustment. When that legislation is as broad and sweeping as the Food Safety Modernization Act (“FSMA”), the period of adjustment can last for years.

In a recent column, we addressed the new federal requirement that food companies (beginning in June 2012) adopt written food safety plans, alternatively referred to as Hazard Analysis and Critical Control Point (“HACCP”) plans. While the initiative may appear relatively simple and straightforward, in practice it may prove difficult for FDA to enforce the new requirements both uniformly and fairly. Thus, we wanted to take a moment to highlight some of the momentous challenges associated with the eventual implementation of the FDA’s new food safety rules.

The concept of HACCP was jointly developed in the 1960's by Pillsbury and NASA in a project aimed at keeping astronaut's food pathogen-free. Microbiological testing, they knew, was only effective to a point. So, they collaborated on a program aimed at understanding where and how failures in food safety occur. The result was HACCP; a program designed to seek out and identify the processing points where food safety risks could be reduced to the greatest extent possible. In the 1990s, FDA mandated HAACP for sea food production, and HACCP was eventually required by FSIS in meat and poultry establishments.

The program has been largely successful in the meat industry, and has led to a pronounced reduction in the number of foodborne illnesses and outbreaks. As with any regulatory initiative, however, it requires continuous refinement as science, technology and consumer attitudes mature. In spite of HACCP’s far-reaching success in the meat industry, it is important to note that the meat industry produces a fairly limited set of distinct products. And, all beef slaughter operations, by nature of the processes used, follow relatively similar HACCP programs. The risks are finite, and can be addressed from one plant to another with identical (or at least similar) interventions. Thus, within the meat industry, establishing uniformity in enforcement and compliance, while never easy, has at least proven somewhat manageable.

The FDA on the other hand, is a whole different kettle of fish. Under the new requirements, each and every food processor will have to identify, categorize and then formally address a unique set of hazards. In other words, the HACCP program at a factory which makes frozen waffles is going to be fundamentally different than the one for a processor who makes yogurt, crackers, seasonings or egg salad sandwiches. There are tens of thousands of food processors in the U.S. making hundreds of thousands of products.

So, how will the FDA ultimately approach the development and implementation of an inspection apparatus that deals uniformly and fairly with thousands of companies producing hundreds of thousands of distinct food products? This, of course, is the million (or, perhaps, billion) dollar question. This is also a question which should be flagged and debated today, as opposed to next year when compliance (however that term is ultimately defined by FDA) will be required.

In a perfect world, FDA could simply publish guidance materials outlining a single HAACP methodology (with a single set of compliance standards) that could be applied uniformly to every manufacturing facility and food product. This, however, would prove impossible. As noted, there are simply too many different food companies producing too many dissimilar food products, and there is no such thing as a one-size-fits-all science-based HACCP program.

Additionally, even if a uniform set of compliance benchmarks could be adopted and understood by all, it remains unclear how the FDA would uniformly enforce those standards throughout its many districts. In each of the FDA’s jurisdictional districts, there will inherently be countless different inspectors each sharing different qualifications. Thus, the follow-on dilemma for FDA will be how to ensure that the cookie producer in New York is ultimately being judged by the same standards as the one in California.

That, of course, presumes that the FDA inspectors will be adequately trained in HACCP. Indeed, before the FDA can determine whether any company is in compliance (again, once this term is better defined by the agency), FDA inspectors will need to gain significant expertise in HACCP. They should, ideally, hold a degree in food science, and have a clear understanding of the risks which exist in the specific products they oversee (which, as noted, could exceed thousands if not more). As of today, however, many FDA and other public health inspectors lack the appropriate food science background. Thus, there is and will continue to be a shortfall of the qualified inspectors needed to build an inspection apparatus of the size and scope necessary to visit, even on a rotating basis, each of the food processing plants in the country.

And, that’s just here at home. In today's rapidly globalizing world, many of the food products in our nation’s grocery stores, gas stations, drug stores and specialty shops contain imported ingredients. From salt and pepper to noodles, brownies and whipped cream, the things we consume often contain ingredients from faraway places. It remains to be seen who, if anyone, will oversee these products.

Thus, it stands to reason that the FDA will have to substantially increase the number and qualifications of its inspectors, not only in the United States, but also possibly abroad, to meet the goals of the FSMA. The FDA must also recognize, however, enforcement will be complicated tremendously if the inspectors who are tasked to ensure compliance lack the basic experience and training needed to oversee a science based a system which, while appearing simple on paper, can in practice be extremely complex.

With that said, both FDA and industry have time to address many of these challenges, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.

The new legislation presents a unique opportunity for industry to partner with FDA in order to prepare for and streamline the implementation of FSMA. In advance of each pending deadline, FDA will invite industry to comment on its proposed rules and regulations. In turn, offer written suggestions, and ask the FDA to define, as precisely as possible, what its ultimate expectations will be. Companies should take maximum advantage of these opportunities, as it will be their best chance to play a role in developing the rules (and, by extension, the expectations) which will one day govern their food safety programs.

As with any large undertaking, active engagement (as well as preparation and planning) will make all the difference between success and failure. Use the time you have now to prepare for the sweeping changes which will soon be at your doorsteps. Lastly, if you do nothing else, work alongside and communicate with the FDA as these changes are instituted. How, exactly, your food safety plan is ultimately enforced may eventually be up to you.
 

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Just yesterday, FSIS formally published its final determination and request for comments relating to its decision last week to declare non-O157 STECs as adulterants in ground beef and trim products. Since the announcement last week, there has been a great deal of concern within the industry over the scope and breadth of the proposed new regulations.  

Generally, FSIS intends to carry out verification procedures, including sampling and testing to ensure control of both O157:H7 and, now, the six other STECs.

To allow industry time to implement possible changes to food safety systems, however, FSIS will generally not regard products found to have these pathogens as formally "adulterated" until it begins this routine testing. As of right now, FSIS intends to begin a routine sampling program for the non-O157 STECs no later than March 5, 2012.

A significant concern for industry at this early stage is the elapsed time between micro-sampling and results. At this point, FSIS estimates that negative (or presumptive positive) results could be available within 48 hours of sampling. For samples that are initially reactive an additional three to five days may be necessary for a confirmed positive or confirmed negative result.

Fortunately, the antimicrobial interventions used by beef manufacturers to control E. coli O157:H7 are believed to be equally effective in controlling non-O157 STECs. Thus, while it is inviting industry comment, the agency "does not anticipate" at this point that industry will have to incur additional cost by implementing new or different interventions. They do, however, “anticipate that many firms will want to implement their own testing programs and even conduct the same kind of testing that FSIS plans to carry out.”

According to FSIS, establishments that manufacture raw, non-intact beef products (or intact raw beef components of those products) will be expected to evaluate whether non-O157:H7 STECs are a hazard reasonably likely to occur. If a company’s HACCP plan cites O157 as a hazard reasonably likely to occur. If so, those companies will also be expected to reassess their HAACP plans and address the new hazard accordingly; likely by testing for it.

Finally, in the event that FSIS finds a non-O157 STEC in a regulatory sample, it will conduct a for cause food safety assessment (FSA), "as it does currently for E. coli O157:H7-positive [regulatory] samples."

With this as the prelude, FSIS is inviting comments on its proposal from public and industry. Since it currently intends to begin testing for non-O157:H7 STECs as soon as March 2012, however, the agency recommends that any comments be submitted no later than November 1, 2011. Thus, while rules are never really meant to be broken, they are, at least in this case, meant to be critiqued. 

So, while FSIS has indeed created a "new set rules" as they apply to non-O157:H7 STECs, you may be able to influence, at least in part, how those new rules will ultimately be implemented and enforced. 

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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.

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Anyone involved in the food industry has now heard about the recent passage of the Food Safety Modernization Act (“FSMA”).

Although the FSMA imposes many new and (some might argue) exotic requirements on industry, the one that will likely have the greatest impact on food companies is the mandate that they “develop and implement written food safety plans.” In turn, many companies are now asking, what does this really mean? Although none of us can be certain until the FDA begins enforcing the new laws (starting in June 2012), we can give you a pretty good sense of what to expect.

Following the passage of the FSMA, and in an attempt to keep things sounding as simple as possible, the FDA announced in its promotional materials that, moving forward, food companies will simply be required to adopt “Food Safety Plans.” But things, of course, are not always as simple as they sound. In regulatory and legal terms, this means that regulated food companies will soon be required to develop and then closely follow the Hazard Analysis and Critical Control Point (“HACCP”) methodology. 

So, what is HACCP? Well, at its most basic level, it’s a system designed to address the food safety hazards we fear most. The HACCP concept was first developed by Pillsbury in the 1960s, as a quality control program to govern the production of food for the United States space program. Under the HACCP methodology, a food processor would first identify the hazards reasonably likely to affect the safety of its food (including the introduction of chemical, physical and microbiological contamination), and then establish various critical control points where interventions could be used to prevent, reduce or control those hazards. Ultimately, HACCP was critically important for NASA as it worked to ensure that the meals its astronauts were taking into space would be as safe (and as free from unwanted contamination) as possible. 

Years later, in the early 1980s, Foster Farms (a California company) was one of the first meat processors to introduce HACCP into its own operations. Thereafter, in 1985, HACCP gained additional notoriety when the National Academy of Science recommended HACCP as a means to modernize the USDA’s meat inspection system. Eventually, in the 1990s, USDA mandated HACCP for all meat and poultry production in the United States. At about the same time, FDA mandated HACCP for all seafood production, and extended these requirements in 2001 (in response to numerous outbreaks involving unpasteurized juices) to the domestic juice industry. And, more recently, recognizing how HACCP has improved the overall safety of these products, FDA successfully petitioned to have the new FSMA extend HACCP to all other segments of the food industry. Thus, with only a few exceptions, the FDA will soon require all food companies regulated by the agency to develop and closely follow their own HACCP plans. 

In turn, according to the FDA, the underlying goal of HACCP is to prevent problems from occurring in the first instance. Although describing the HACCP methodology can be somewhat complex, food companies will generally be required to: (1) formally consider and identify all reasonably foreseeable food safety hazards; (2) develop written plans addressing each of those hazards; and (3) closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.  More specifically, the underlying principles of HACCP will require regulated food companies to do the following:

1. Assess Hazards: Conduct a hazard analysis to identify reasonably foreseeable food safety hazards, and develop reasonably appropriate control measures for each;

2. Determine Critical Control Points: Identify appropriate critical control points (“CCPs”) where a control measure can be applied to prevent or reduce an identified hazard;

3. Establish Critical Limits: Define acceptable and unacceptable science-based limits for all CCPs, and use those limits to ensure the production of a consistently safe product.

4. Establish Monitoring Procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits which may occur; 

5. Establish Corrective Actions: Develop procedures to be followed in the event of a deviation, which should include an assessment of the root cause, the disposition of affected product, and a written record of any corrective actions;   

6. Establish Verification Procedures: Test and critique the HACCP plan, once designed (and periodically thereafter), to verify that the HACCP plan is working correctly;

7. Establish a Record Keeping System: Develop a system to maintain and catalog all HACCP documentation for at least 2 years, in such a form that any records can be promptly made available to the FDA if requested by the agency for inspection.

Recognizing this may be a lot to swallow, there are plenty of resources available to help companies develop their own HACCP plans. As a starting point, and although they should never be used as a substitute for a well-designed program which will withstand agency scrutiny in your specific facility, both the FDA and numerous industry associations have published basic guidance materials online (and will likely be publishing additional materials in the months to come).

In addition to these background materials, there are numerous industry consultants and lawyers who will be available to help you develop, refine and critique your HACCP plan. In this regard, all companies should strongly consider obtaining advice from a qualified expert in the field as they work to ensure compliance. This is because a company’s HACCP plan will not only need to be scientifically and legally sound, but the plan itself will, for all practical purposes, become a direct extension of in-plant federal FDA regulation. Put simply, the FDA’s new regulations will not only require that your HACCP plan be adequate, but that it also be followed precisely.

So, what IS a Food Safety Plan?  Technically speaking, it is a comprehensive science-based HACCP plan. In lay terms, however, it’s a proven system designed to address the food safety hazards we fear most.

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The Food Safety Modernization Act (“FSMA”) has now been law for more than six months. In turn, FDA issued a progress report on its implementation efforts since the FSMA was signed into law last January:

Preventive Controls:

In April, almost 500 persons participated in the agency’s public meeting seeking information on preventive controls used by industry to identify and address hazards associated with specific types of food and specific processes. FDA is actively seeking further industry comment (through August 22) on its rulemaking for preventive controls. Please click on the following links to review the docket on preventive controls and submit your comments electronically or via mail.

Imported Foods:

More than 500 persons were given the opportunity in a March public meeting to weigh in on each of the four FSMA import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; Voluntary Qualified Importer Program; and Foreign Supplier Verification Program.

On May 5, 2011 FDA issued an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Food Smuggling:

On July 3, 2011 FDA issued a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to prevent smuggled foods from entering the United States and potentially threatening consumer safety and national security.

Registration Suspension:

Effective July 3, 2011 FDA has the power to suspend the registration of a food facility, thus ceasing operations, if it believes there is a “reasonable probability” that food from the facility could cause harm to humans or animals.

Administrative Detention of Food:

Also on July 3, 2011 the rule on criteria under which FDA may order administrative detention of food product went into effect. FSMA lowered the standard, granting FDA the power to detain food product for up to 30 days if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. Click on the following link to review the Rule on Administrative Detention.

Seafood:

FDA issued an updated guide to the seafood industry on appropriate controls for hazards associated with fish and fishery products. Industry may employ different controls if the alternative controls satisfy the applicable statute and regulations. Click on the following link to view Seafood Hazard and Control Guidance.

Inspections and Compliance:

In June, almost 700 people participated in the agency’s public meeting regarding FDA’s development of guidance and regulations and/or the implementation of: Enforcement Authorities; Frequency and Targeting of Facility Inspections; Manner of Inspection in a Preventive Controls Environment; and Enhancement of the Reportable Food Registry (RFR).

Funding:

FDA’s progress report did not touch on what might be FSMA’s biggest obstacle: funding. The agriculture appropriations bill recently passed by the House of Representatives would decrease funding to the FDA next year by $87 million.

Hopefully, the agency is receiving abundant, constructive advice from industry that will lead to practical regulations which facilities can utilize to improve their food safety, regardless of whether FDA is able to frequently stand over their shoulders and inspect.
 

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Moving forward, the Food Safety Modernization Act (“FSMA”) requires the U.S. Food and Drug Administration (“FDA”) to issue rules governing preventive controls in FDA registered food facilities. In turn, food facilities must develop, no later than June 2012, written Hazard Analysis and Critical Control Point (HACCP) plans which are compliant with those rules.

Under FSMA, HACCP plans must identify all known or reasonably foreseeable hazards that may be associated with a food facility and then spell out the preventive controls which assure that the hazards will be minimized or prevented and food will not be contaminated.

Effective preventive controls yield safer food and are, undoubtedly, one of the top weapons against foodborne illness. Given the incredibly diverse range of food facilities and products which FDA regulates, how can its rule on preventive controls reconcile with the equally diverse range of controls needed by these facilities?

Hopefully, industry input will help. “The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety,” said Michael R. Taylor, deputy FDA commissioner for foods. “It’s imperative that we get information, data and feedback from industry and other stakeholders.”

FDA held a public meeting regarding preventive control rule-making in April (click on the following link to view the public meeting transcript), and is now seeking industry comment in electronic or written form through August 22, 2011. Click on the following link to submit your comments electronically or via mail.

FDA regulated food facilities should take care to review the status of preventive control rule-making, and also provide comments to help, where possible, shape the new regulations.  Click on the following link for updates on the status of FDA preventative control rule-making.
 

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I will dare to venture that many people do not appreciate the vital role our local and state health departments must play in the health of our communities. Health departments perform a wide range of wellness initiatives, including, just to name a few: reaching out to new parents, educating about disease prevention and management, promoting clean air and water, administering to low-income families and the elderly, and supplying disaster assistance. In addition, our health departments track a dizzying array of statistics to monitor and improve our well being.

Health departments also play an important role in assuring food safety by teaching about safe food handling practices, inspecting grocery stores and restaurants, and investigating foodborne illnesses and outbreaks.

Given the significance of public health, a movement has been underway since 2007 to create a national system for ensuring the accountability and quality of our health departments. Spurred by two Institute of Medicine studies which found that public health in America was in disarray, the non-profit Public Health Accreditation Board (“PHAB”) was created and tasked with launching a national public health accreditation program.

The CDC, a sponsor of PHAB, stated that "Just as the public expects hospitals, law enforcement agencies and schools to be accredited so should they come to expect public health departments." The accreditation program, set to launch this coming fall, requires health departments to meet stringent requirements for 10 essential areas of public health activities and demonstrate a commitment to constant improvement. Some of the benefits of accreditation include:

• People from the east to west coast can expect the same quality of health services no matter where they live;

• The accreditation process provides measurable feedback to health departments on their strengths and weaknesses so they can better serve;

• Accreditation is an opportunity for health departments to promote what they do and show taxpayers that dollars are well spent; and

• Top health professionals will be drawn to employment at accredited departments.

One area in which health departments will be evaluated is their ability to investigate environmental health hazards. Whether a health department meets this standard could mean the difference between your company’s future success or future decline.

Largely due to an increase of reported foodborne illnesses and outbreaks (brought about by advances such as PulseNet and PFGE and MLVA testing), health departments are under increasing pressure to solve more and more outbreaks at any one time. In turn, this pressure, and limited or unqualified resources, can lead health departments to reach erroneous conclusions about the sources of foodborne illness outbreaks. Unfortunately, I have defended several wrongly accused, innocent companies.

I have had the pleasure of interacting with some incredible health departments, but based on my numerous poor experiences, it is a solid step for all health departments to apply to this voluntary accreditation program. If a health department does not apply to compare itself against the other health departments in the country, and the national standards approved by PAHB, then communities should ask why. Accredited or not, however, if a health department report comes across my desk, we will, as always, thoroughly verify its conclusions before advising our clients.

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In November 2009, U.S. Rep. Rosa DeLauro, Chairwoman of the House Agriculture-FDA Appropriations Subcommittee, asked the USDA’s Office of Inspector General (“OIG”) to investigate the efficacy of the Food Safety and Inspection Service’s (“FSIS”) N-60 sampling method to test beef trim for E. coli O157:H7.

In response, the OIG spent six months, from January to June 2010, auditing the FSIS’s N-60 program, and then issued the first portion of its findings in March 2011. Click on the following link to view a copy of the “Phase I” report. The detailed, 40-page report concludes that FSIS must thoroughly reevaluate its N-60 sampling program for testing beef trim.

The report demonstrates that an incredible amount of work has been done, and remains to be done, by both the OIG and the FSIS on this issue. The OIG has not yet even performed “Phase II” of its investigation. The bottom line is that FSIS will increase the amount of testing it performs for E. coli O157:H7.

While some positive changes will flow from the OIG investigation (perhaps from the Phase II evaluation of whether plants are following proper protocols for their own sampling and testing), there are valid questions about the investigation’s merit. Should so many more resources be invested in the concept of testing when we can never test to zero? As the prevalence of E. coli O157:H7 in beef continues to decrease, are we just going to continually increase our testing to look for a needle in the haystack that, thankfully, is now rarely present? Can the FSIS rely more heavily on the robust E. coli O157:H7 testing already being done by industry?

Testing is an important part of the validation process, but as OIG concedes, “testing alone cannot suffice to ensure that consumers are safe from a pathogen like E. coli O157:H7.” It is striking that the response to Rep. DeLauro’s request to the OIG regarding N-60 testing was expedited, but the industry’s petition to the FSIS for carcass irradiation has gone unanswered (Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology).

Over five years ago, the American Meat Institute (“AMI”) submitted a petition to the FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of this technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

Carcass irradiation is an intervention that could immediately increase the safety of our food. We implore the FSIS to approve carcass irradiation without any further delay.
 

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Attention grabbing headlines in recent media reports have suggested that Staphylococcus aureus (S. aureus) exists in nearly half of U.S. meat.  The authors of a study published in the journal Clinical Infectious Diseases recently suggested that “U.S. meat and poultry is widely contaminated.” Researchers collected and analyzed samples of beef, chicken, pork and turkey and reported that nearly half of the samples — 47 percent — were contaminated with S. aureus bacteria, and more than half of those bacteria — 52 percent — were resistant to at least three classes of antibiotics.

In turn, many of these stories have improperly questioned the safety of our meat supply.  The study, however, likely creates little cause for concern.

Setting aside the fact that S. aureus are easily destroyed when meat (or any other food products) are cooked properly, American Meat Institute (“AMI”) concluded, and we agree, that the research was also misleading for the following reasons:

• The study’s small sample size was insufficient to reach the sweeping conclusions conveyed in a press release about the study. The study involved only 136 samples of meat and poultry from 80 brands in 26 retail grocery stores in five U.S. cities. In comparison, when the U.S. Department of Agriculture studies the prevalence of bacteria, their work involves thousands of samples collected over long periods of time to ensure accuracy.

• Data from the Centers for Disease Control and Prevention show steady declines in foodborne illnesses linked to consumption of meat and poultry overall and indicate that human infections with S. aureus comprise less than one percent of total foodborne illnesses.

• According to a new white paper authored by Ellin Doyle, Ph.D., of the University of Wisconsin’s Food Research Institute, S. aureus bacteria are found in half of all human nasal passages, and only two foodborne outbreaks of the antibiotic resistant strain of this bacteria (“MRSA”) have been identified and both were attributed to food handlers contaminating food – not to the food source itself.

• The study criticizes U.S. production methods and suggests that they cause antibiotic resistant bacteria to develop, but Doyle’s white paper documents that similar incidence patterns can be observed in livestock in many countries with a variety of different production methods.

Industry has developed amazing processes and technologies to render American meat and poultry the safest in the world, and consumers can take simple steps to make it even safer. This study made headlines about bacteria being found in “nearly half” of our meat. The reality is, however, that consumers should treat all raw meat as if it contains bacteria. Raw meat must be stored and prepared separately from ready-to-eat foods. Restaurants and homes must have cutting boards designated solely for raw meat. Hands, utensils and any surfaces which come into contact with raw meat must be carefully washed. Finally, cooking raw meat to the proper temperatures will destroy bacteria.

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The FDA's Food Safety Modernization Act (FSMA) is now LAW.

On April 21, 2011, nationally-recognized food safety professionals gathered at Marquette University Law School in Milwaukee to explain the new legislation and how the new laws will affect the food industry.  Representatives from federal and state food regulatory agencies, leaders of numerous food industry groups, and food safety executives from some of the largest food companies in the nation offered their unique perspectives, and answered pressing questions, regarding the new law

This industry-leading food safety conference (the New Food Safety Modernization Act -- Approved) was a huge success.  In turn, we are looking forward, in coming months, to offer a similar program as FDA continues to develop and publish the new food safety regulations which will soon follow.

Click on the following link to download a copy of the seminar program, and feel free to contact us for additional details regarding future events:

 

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In January 2000, the U.S. Department of Health and Human Services (“HHS”) published Healthy People 2010, a 10-year agenda for improving our Nation’s health. The agenda included future goals relating to the overall reduction of foodborne illness. Fast forward 10 years, and we find that the agency’s goal regarding E. coli O157:H7 (“E. coli”) was met and actually exceeded. The target for Salmonella, however, was far from the mark.

HHS had hoped that, by 2010, there would be only 1 case of E. coli O157:H7 and 6.8 cases of Salmonella reported per 100,000 people. FoodNet data from 2009 showed the actual number of E. coli illnesses was .9 per 100,000, and Salmonella illnesses was 15.2 per 100,000. The actual number of Salmonella cases in 2009 was more than double the Healthy People 2010 goal.

Industry and government (and the media) have intensely focused on E. coli since 1993. The incredible result of that focus and determination is a 41% decrease of laboratory confirmed E. coli illnesses in the past ten years (per FoodNet). Now that the data on Salmonella is clear, and following directives made by the President’s Food Safety Working Group, the Food Safety and Inspection Service (“FSIS”) and U.S. Food and Drug Administration (“FDA”) have indicated that more of their attention will be turned to Salmonella.

FSIS recently announced the implementation of more aggressive performance standards relating to the prevalence of Salmonella in chicken and turkey products. The new standards, set to take effect in July 2011, are projected by the USDA to reduce the numbers of foodborne illness in the United States by as many as 25,000 within two years.

The new standards reduce the acceptable levels of Salmonella to 7.5 percent in young chickens, which equates to a maximum allowable positive rate of 5 in 51 samples (and a slightly lower 4 in 51 samples for turkeys). The previous standard, in effect since 1996, allowed for a positive rate up to 20 percent.

Last summer, the FDA issued a much stricter food safety rule aimed at decreasing egg-related Salmonella illnesses. Under the new requirements, egg producers whose shell eggs are not processed with a treatment such as pasteurization must adopt new measures to prevent Salmonella contamination, conduct testing in the poultry house, and ensure proper refrigeration during storage and transportation.

The FDA expects the regulation to prevent approximately 79,000 cases of Salmonella each year. The FDA is also counting on new inspection powers and more funding under the Food Safety Modernization Act to factor into the success of the rule.

The HHS has set a more modest target for Salmonella in Healthy People 2020: 11.4 cases per 100,000 people. Hopefully, industry and regulator ingenuity can meet this challenge.

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The U.S. Food and Drug Administration (“FDA”) has released its annual report regarding the first year of operation of the Reportable Food Registry (“RFR”).

The RFR is an internet based portal for Registered Food Facilities to report potential problems with FDA-regulated food and feed products. Facilities that manufacture, process, pack, or hold food or feed must submit a report when there is a reasonable probability that a product will cause serious adverse health consequences to humans or animals.

The RFR was activated in September 2009 in accordance with the FDA Amendments Act of 2007 to: (1) provide a “reliable mechanism to track patterns of adulteration in food;” and (2) “to target [the FDA’s] limited inspection resources to protect the public health.”

Between September 2009 and September 2010, a total of 2,240 reportable food submissions were entered into the RFR. Of these 2,240 entries, 229 were primary reports, 1872 were subsequent reports as a result of a primary report; and 139 were amendments to previously submitted reports.

A primary report is an initial report concerning a reportable food from either industry or public health officials, while a subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted. FDA’s annual report succinctly lays out what contaminants and what types of food comprised the 229 primary reports. The pie graph below illustrates the seven food safety hazards found in the primary reports:

         

Sixteen (16) primary reports concerned Salmonella in spices and seasonings. The FDA reported that in response to this RFR finding, a national spice trade association is developing guidance to reduce the risk of pathogen contamination in spices. FDA also reported a second industry change driven by the RFR: one of the nation’s largest baking industry trade associations is enhancing its industry guidance on preventing unintended allergens from being introduced into bakery products.

Passage of the new Food Safety Modernization Act (“FSMA”) has also placed many new responsibilities on the FDA’s shoulders. The FSMA has increased the frequency of FDA inspections of all facilities, so whatever inspection capability is left over must be devoted to the most high-risk commodities.

Of the 229 primary reports, 226 were submitted by industry and just 3 were entered by federal and state regulatory officials.

It should be noted that 1,000 of the 1,872 subsequent reports were related to the massive recall of Hydrolyzed Vegetable Protein (“HVP”) in March 2010 due to Salmonella concerns. The manufacturer of the HVP notified its many customers of the situation and each customer then submitted a subsequent report.

The FDA annual report regarding the RFR stated that no illnesses related to the HVP recall were reported. Likewise, the report stated that no illnesses related to a separate recall for an undeclared allergen were reported. To date, it would appear that no serious health problems were reported in connection with any of the RFR reports.

The RFR also tracks data on reports concerning foods and ingredients from international sources. This first year showed that 53 of the 229 primary reports were caused by foods or ingredients from foreign sources, coming from at least 21 different countries. China caused 13 problems, the most, while Mexico took second place with 5 issues. Click on the following link to view a copy of the the FDA’s most recent RFR ANNUAL REPORT.

Moving forward, the RFR will continue to play a significant role in food safety regulation. Thus, contact our firm for additional information if you have any questions regarding how the RFR works, or the circumstances under which your own company may someday need to submit a report.
 

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In recent years, delis have greatly expanded their product portfolio, catering to a growing need for more ready-to-eat items in a faster paced world.

For these reasons, food safety in delis has never been more important.  One of the most critical control points for food safety in delis (as well as restaurants and other foodservice establishments) is the slicer, which is commonly used to slice meats, cheeses and produce.

Unfortunately, deli slicers can sometimes be difficult to clean. According to the U.S. Food and Drug Administration (“FDA”) Food Code, deli slicers should be disassembled, cleaned and sanitized per the manufacturer’s instructions at least once every four hours to prevent the growth of disease-causing bacteria.

This, of course, can create numerous challenges for food companies. First, the task may be difficult to accomplish in a busy deli or restaurant which relies on slicers throughout the day to meet unpredictable customer demand. Second, slicers may become more difficult to properly clean over time.

Seals and gaskets within a typical deli slicer may become worn or degraded as a result of heavy use and cleaning. In some instances, this can create spaces that trap debris and moisture, and these spaces may not be able to be adequately cleaned under normal conditions. Thus, slicers should be frequently examined by operators for worn or broken parts and seals, and regularly serviced by manufacturers.

Large scale foodborne disease outbreaks allegedly linked to deli slicers have recently prompted a national study on slicer food safety. In one outbreak, seventy-two patrons of a restaurant became ill with Salmonella over a three-month span. The same strain of Salmonella which sickened the patrons was found on the restaurant’s slicer.

Currently, the Rhode Island Department of Health is leading a nation-wide study regarding the extent to which inadequately cleaned or poorly designed slicers are causing foodborne illness. The department’s investigation has confirmed that slicers are not always being properly sanitized every four hours. Additionally, the department identified three brands of slicers with certain design limitations that can inhibit proper cleaning.

Hopefully, a new initiative by the FDA will bring a renewed effort on this food safety issue. The FDA developed a poster and flyer designed to raise awareness of the sanitation concerns with slicers. The poster, which explains the importance of proper slicer maintenance and highlights examples of hard-to-clean problem areas, can be tacked up right beside a slicer.

The flyer provides tips for food safety professionals inspecting deli slicers. Click on the following link for the FDA’s press release, or to download or order the poster and flyer at no charge.
 

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The FDA Food Safety Modernization Act (“FSMA”) is now law.

The FSMA is the first major amendment in almost 75 years to the food safety regulations of the Federal Food, Drug and Cosmetic Act.

Since FDA regulated manufacturers may feel overwhelmed by the 89 page act, let’s take a deep breath and walk through some of the FSMA’s key provisions -- and when they go into effect.

The FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products regulated by the USDA. The new law grants additional power to, and also places additional requirements on, the FDA:

• Inspections: FDA must inspect high-risk food processing facilities at least once in the next five years, and once every three years after that. Low-risk facilities must be inspected at least once every seven years. [Effective immediately].

• Detentions: FDA has the authority to detain food product if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. This is a lower standard than under the FD&C Act. [Effective June 2011].

• Suspensions: FDA may now suspend facility operations if it believes there is a reasonable probability that food from the facility could cause harm to humans or animals. [Effective June 2011 or upon FDA’s issuance of regulation to implement].

• Recalls: FDA now has the authority to force a food recall. [Effective immediately].

• Performance Standards: FDA must evaluate relevant health data every two years to determine the most significant foodborne contaminants and then issue guidance documents or regulations setting contaminant-specific performance standards. [Effective date undetermined, implementation requires FDA rulemaking].

• Imports: FDA may require importers to provide a safety certification from an accredited third-party auditor as a condition of granting admission. [Effective immediately.]

Under the FSMA, food companies will also now have to develop and implement Hazard Analysis and Critical Control Point (HACCP) plans. Although this may initially be a burdensome task, companies implementing strong HACCP protocols will, most importantly, produce safer food. And further, companies executing good HACCP controls may see strong inspection results and avoid detentions, suspensions and recalls.

The written HACCP plan must include five elements:

• Hazard Analysis: Food companies must identify and evaluate all known or reasonably foreseeable hazards that may be associated with the facility (such as biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives, and hazards that may be intentionally introduced) and prepare a written hazard analysis.

• Preventative Controls: Food companies must identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food processed by the facility will not be adulterated or misbranded.

• Monitoring: Food companies must monitor the effectiveness of the facility’s preventive controls.

• Corrective Actions: Food companies must establish procedures to ensure that, if preventive controls are not properly implemented or are found to be ineffective: (a) appropriate action is taken to reduce the likelihood of a recurrence (b) all affected food is evaluated for safety (c) all affected food is prevented from entering commerce if the company cannot ensure it is not adulterated.

• Verification: Food companies must verify that the facility’s preventive controls are adequate to control the hazards identified in the hazard analysis, that monitoring is being conducted, that appropriate decisions about corrective actions are being made, and that there is periodic reanalysis of the HACCP plan.

In addition, food companies must maintain, for not less than 2 years, records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other means of verification, corrective actions, and the efficacy of preventive controls and corrective actions. These records must be made available to FDA upon request.

Food companies, other than small businesses, must have their HACCP protocols in place by June 2012.

Other notable requirements placed on food companies by the FSMA include:

• Registration:  Food companies must register with the FDA biennially, between October 1 and December 31 of each even-numbered year. [Effective immediately.]

• Imports: Food importers must perform risk based foreign supplier verification activities to verify that the food imported is not adulterated. [Effective January 2013.]

• Additional Future Performance Standards: Food companies must engage a Federal laboratory or other accredited laboratory to perform analyses of food products and submit the results directly to the FDA. [Effective January 2013.]

While many of the FSMA’s key provisions do not take effect for a year or more, it is critical that food companies begin planning for these changes now. If your company already operates under the HACCP methodology, now is the time to re-evaluate your plan and verify it will comply with the FSMA standards. If your company has not yet implemented a HACCP system, now more than ever is the time to enhance your food safety system with formal recognition and monitoring of potential hazards.

Please contact us with any questions regarding these significant changes in food safety law.

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“Foodborne diseases cause approximately 76 million illnesses each year in the United States.”

For the past 11 years, this statement has been quoted in countless news stories, scientific studies, legal documents, and arguments for expansive government regulations. The number “76 million” was an estimate calculated by the Centers for Disease Control and Prevention (CDC) in 1999. However, the estimate truly morphed into more of a factual statistic, the perfect lead-in or conclusion to every tale of foodborne illness.

The CDC just completed a second review on the impact of foodborne diseases and has released new figures in two studies published in the journal Emerging Infectious Diseases. The agency now estimates that about 48 million Americans get sick each year from foodborne diseases (a difference of 28 million people). CDC explained that the difference between the 1999 estimate and the current estimate is due to improvements in the quality and quantity of the data used and new methods used to estimate foodborne disease. CDC further described the approximation as follows:

Of the total estimate of 48 million illnesses annually, CDC estimates that 9.4 million illnesses are due to 31 known foodborne pathogens. The remaining 38 million illnesses result from unspecified agents, which include known agents without enough data to make specific estimates, agents not yet recognized as causing foodborne illness, and agents not yet discovered. In both the 1999 and current estimates, unspecified agents were responsible for roughly 80 percent of estimated illnesses.

An estimated 38 million illnesses (out of the total estimated 48 million illnesses) each year are thought to be caused by foodborne diseases that cannot yet be tracked or have not even been discovered.

The scientific guesswork behind “48 million” is hard for me to swallow because this estimate, as its predecessor of 76 million, will be used as a statistic to vilify our food industry. “48 million” will be touted before the masses in newspapers, movies, courtrooms, and Washington, D.C. as evidence that our food manufacturers are not even coming close to doing enough.

CDC is an incredibly valuable institution which has helped advance food safety in many aspects. Industry has learned food safety lessons from CDC’s research, and I concede that CDC’s new studies have value when properly utilized. However, it is a shame that “48 million” will be extrapolated from those studies and regularly, perhaps even exclusively, referenced without a full explanation of the estimation. Rest assured that this number will not be uttered when I am in the courtroom.

Within the CDC’s new studies is hard data evidencing that industry has made significant progress in the war on food safety. CDC stated that FoodNet provides the best measure of trends in foodborne diseases. FoodNet is a surveillance system designed to detect and collect information on every person in 10 states (representing 15% of the U.S. population, or 46 million Americans) with a laboratory confirmed case of foodborne illness. FoodNet completed an analysis comparing its data from 2009 with data from two other time periods and found:

• Rates of infection were at least 25% lower for Shigella, Yersinia, Campylobacter, and Listeria than they were a decade ago.

• Rates of infection with E. coli O157:H7, which causes one of the most severe forms of foodborne illness, decreased by 25% in 2009 compared with the most recent 3 years, reaching the lowest level since 2004.

As always, I am proud to defend the hard working Americans who feed our families and I will not allow their accomplishments to go unnoticed.

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After weeks of haggling, Congress has now passed the Food Safety Modernization Act.

A few weeks ago, we all thought the new law (passed in its then-current form) was headed for the President’s desk. We soon learned, however, that the legislation which had passed was, in fact, technically unconstitutional. Because the bill inadvertently contained certain revenue provisions, it should have originated in the House of Representatives, not the Senate. These issues have been resolved, Congress approved the legislation shortly before Christmas, and the bill is now heading to the White House.

Click on the following link to view the text of the bill:  Food Safety Modernization Act.

The Food Safety Modernization Act (“FSMA”) will govern food processors and products regulated by the U.S. Food and Drug Administration ("FDA"). The new act increases federal inspections, requires virtually all regulated food companies (with very few exceptions) to adopt Hazard Analysis and Critical Control Point (“HACCP”) plans, and grants the FDA mandatory recall authority. The new legislation also proposes to enhance our nation’s foodborne illness surveillance and tracking capabilities.

The biggest change for food companies, however, will be the new HACCP requirements. Under the new law, food companies will be required to: (1) formally consider and identify all potential food safety hazards associated with their products and operations; (2) develop written plans to respond to each of those hazards; and (3) to closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.

Not only will the HACCP plans developed by these companies need to be legally adequate (something which will likely prove extremely difficult to define and enforce on a consistent basis), the resulting plans themselves will also, for all practical purposes, become an extension of in-plant federal regulation.Thus, as companies develop and implement their own individualized HACCP plans, they should also recognize that they will be expected by FDA to follow them precisely. Click on the following link to see a more in-depth discussion of the new law and possible ramifications: Jolley: Bill Marler & Shawn Stevens Talk About The New Food Safety Modernization Act .

Although not all provisions of the new legislation will go into effect immediately, food companies should begin planning for the changes that are likely to occur.

There have also been some recent notable developments relating to produce. Beyond the FSMA itself, the FDA has also announced the creation of a new organization that will likely impact produce growers and packers in the near future. The Produce Safety Alliance is a public-private organization funded by the FDA and United States Department of Agriculture’s Agricultural Marketing Service.

The three-year, $1.15 million alliance aims to help produce growers and packers access food safety educational and training materials by:

• Developing a program on Good Agriculture Practices (GAPs) and co-management;

• Creating an information bank of up-to-date scientific and technical information related to on-farm and packinghouse produce safety and environmental co-management;

• Establishing a network of educational collaborators;

• Conducting an assessment of existing educational outreach tools to identify knowledge gaps and to provide for continuous updating; and

• Launching a website to make the alliance’s work and information readily accessible.

The alliance was also created to assist growers and packers with a new produce safety regulation that the FDA expects to propose in 2011, which will focus on production, harvesting and packing. FDA Deputy Commissioner for Foods Michael Taylor said “As we traveled around the country listening to growers and packers and soliciting their comments even before we propose a produce safety rule, we have committed ourselves to just this kind of collaborative effort.” As always, share your experiences and views with FDA at every opportunity afforded to you.

Put simply, the Produce Safety Alliance aspires to create a one stop shop for the food safety needs of produce growers and packers. The California Leafy Greens Marketing Agreement (LGMA) endorses the alliance and hopes to participate on the alliance’s steering committee. Jamie Strachan, chairman of the LGMA’s advisory board said “The objectives of this new initiative are in line with those of the LGMA.” The alliance’s steering committee will be comprised of government officials as well as industry leaders, including growers and packers and produce trade organizations.

In any event, one question often asked is whether the FSMA will make our food safer. I think the answer is yes. Regardless of where you stand politically on the issue, I think we could all agree that requiring all food companies to develop and follow HACCP plans will have a net positive effect on food safety. Moreover, under the new laws, it should become easier for food safety lawyers like us to defend food companies faced with a foodborne illness claim or caught in an outbreak scenario.

In response to the new rules and regulations now on the horizon, most food companies will be working to enhance their food safety programs. Understanding that, despite our best efforts, mistakes can and will occur, we would much rather be defending food companies with robust food safety programs than defending those companies with none at all.
 

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The Food Safety and Inspection Service (“FSIS”) revealed its vision for 2011 at the North American Meat Processors Association’s Annual Outlook Conference. Briefly, Dr. Dan Engeljohn, FSIS’s chief policy writer, touched on the following:

• Salmonella will receive more attention in 2011;
• A HACCP Validation Guidance Draft will be issued in early 2011;
• New regulations for labeling non-intact product may be published in late 2011;
• FSIS will respond to the industry’s petition for carcass irradiation “fairly quickly” (the petition has been pending for five years);
• FSIS will focus more on pre-harvest and carcass interventions for beef in 2011.

With regard to the last point, Dr. Engeljohn said that the agency is developing a draft protocol to study beef carcass contamination levels, with the anticipation it will lead to better controls immediately after hide removal. In conjunction with the carcass study, the FSIS will also conduct tests on cattle and water in holding pens. Dr. Engeljohn said pork, poultry and veal slaughter facilities should expect a similar approach from FSIS.

Food manufacturer Cargill has already placed incredible emphasis on preventing contamination at its root. The company, along with Epitopix and the National Cattleman’s Beef Association, developed a cattle vaccine project aimed at reducing E. coli O157:H7 in cattle before they reach the processing plant. On Monday, Cargill announced encouraging preliminary results from its first vaccine trial.

The first trial, at a cost of $1 million, involved 85,000 head of beef cattle from 10 feedlots. The vaccinated cattle, harvested by Cargill from May through August, had a favorable immune system response to the vaccine with no adverse reaction. There was enough promising evidence in the first trial that the company will conduct a second trial in summer 2011.

Dan Schaefer, Cargill assistant vice president for beef research and development stated “While additional research is required to better understand vaccine's potential value in controlling E. coli O157:H7 from farm and feedlot to consumers, we're committed to that pursuit. We continuously strive to provide the safest food possible, every serving, every time.”

We are certainly hopeful that the continued endeavors of government and industry alike will yield safer food in 2011 and beyond.
 

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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.

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Our food safety lawyers have defended food industry clients for more than a decade. During this period, we have worked closely with numerous food companies reducing their risk, managing their recalls and defending their claims.

It’s also been ten years since my colleagues and I first stepped through the doors of a beef slaughter facility. It was a frosty dawn. The early morning sun was just cresting the horizon as we passed through the guard station and into the parking lot. Having only the most basic understanding of what went on in a slaughter facility, we were curious and apprehensive.

It was a transformational experience. Leaving the plant that day, we felt as though we had suddenly become a part of something very important. We saw the unwavering effort exuded by hundreds of employees in each aspect of their jobs. We witnessed first-hand the cleanliness and efficiency of dedicated employees working to ensure a safe and plentiful product, and we were honored to be given the opportunity to defend them.

Ten years and hundreds of cases later, we are honored that industry continues to call upon our food safety attorneys in its most difficult times. We are, as we were that early morning years ago, proud of what our industry does and what our industry stands for.

Our food safety team also takes great pride, not only in defending clients in the face of a recall, outbreak or lawsuit, but also in working to reduce their risk in the first instance. Over the years, we have enjoyed sharing our vast experience and teaching our colleagues and friends about the latest in food safety litigation here and abroad. In 2010, we addressed audiences at food safety conferences throughout the United States, Mexico, Canada and China. And, as the food safety landscape continues to transform, we will continue to help our industry clients stay ahead of their most pressing issues, and abreast of new and emerging trends, technologies and regulatory developments.

Our team had made a difference in other ways as well. We were given the recent privilege of hosting the newest weekly Meatingplace Industry Blog, Legally Speaking, as well as authoring monthly food safety columns for the National Provisioner and Food Quality Magazine.

And finally, I would note that our firm logo (contained in the upper left-hand corner of this blog) is emblematic of our approach to food safety. We have been leaders in this area for nearly decade. In turn, our logo represents the relationship we share with each of our food industry clients. It is symbolic of the responsibility they have given us, and our unwavering obligation to honor it. Finally, it represents our responsibility as both advocates and litigators — to carry our clients (as well as their burdens) across the tightrope of risk.

As we continue to shoulder our clients’ most difficult cases, the food safety lawyers at Gass Weber Mullins will also, of course, continue to lead the way.
 

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Two years ago, we lauded High Pressure Processing (“HPP”) as “one of the most promising food safety technologies.” As it turns out, we were right.

In 2005, the American Pasteurization Company (“APC”) became the first company in the country to offer HPP on a commercial tolling basis. Just five years after the company opened its doors, we are excited to report that APC has been embraced by industry and the company is expanding.

As we wrote previously, HPP is a post-packaging pasteurization technique. The technology can be applied to food products with high water content, such as ready-to-eat meat and poultry products, seafood, fruits, vegetables and soft cheeses. HPP works by uniformly applying up to 87,000 psi of hydrostatic pressure to foods, often in their final packaging, for up to three minutes. The hydrostatic pressure does not compress the food product, but it does destroy food-borne pathogens and spoilage microorganisms.

APC’s first processing facility in Milwaukee started with just two employees processing about 5,000 pounds of food each week. Today, the company’s staff numbers over 50 and is processing more than 700,000 pounds per week. In order to meet the growing demand, APC just opened a second processing facility in Evansville, Indiana. The company hopes to open even more locations across the United States in the future.

The benefits of HPP are especially significant given its proven ability to eliminate food-borne pathogens in certain products. The emotional and financial toll of a food-borne illness outbreak and product recall can devastate a manufacturer. The average cost of a recall to companies is $10 million, in addition to brand damage and lost sales. Thus, by removing pathogens from treated products, and by extension all associated risk, the long term benefits can be substantial.

HPP can also double a product’s shelf life while simultaneously removing the manufacturer’s need to add chemical preservatives. Longer shelf life means longer production runs and fewer markdowns. The business of one APC customer went from static to growing when, with an extended shelf life, it was able to switch its product from frozen to fresh.

These feats are accomplished without the use of chemicals or irradiation, and amazingly, without affecting product quality, thus satisfying some the most significant consumer issues right now: (1) safe; and (2) natural. While irradiation has remained controversial for many years, HPP is quickly gaining a much wider acceptance.

With regard to regulatory compliance, HPP is USDA and FDA approved and helps processors comply with current Listeria regulations. APC “works with food processors in many ways to make the utilization of HPP as seamless and cost effective as possible.”

So is there any downside to HPP? Well, yes. While HPP makes our ready-to-eat meats, raw shellfish, and salsa safer, the process cannot yet be applied to all foods. The good news is that APC is diligently working to expand HPP’s portfolio of products, which will hopefully someday include ground beef.

We are grateful and happy for our friends at APC who now anticipate processing more than 50 million pounds of safe food each year!

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It was won on beef.

It has long been said in America, that for those who seek new frontiers, adventure and a good hard day’s work, all roads lead west.

A lot has changed since the days of Bill Hickok and the Wild West. But, as with those truths we hold to be self-evident, some things remain the same.

The Cowboy has always been a symbol of pride, independence and the vast, untamed wilderness which once stretched across our nation. The American cowboy is legendary, not just here in the United States, but around the world for strength and toughness. More than anything else, the cowboy embodies the principle that here, in America, a good work-ethic trumps a fancy last name every time.

It is easy to lose sight of the fact that, even today, for every steak and every hamburger enjoyed amongst friends, family and loved ones, there are ranchers out there giving everything they can to ensure their cattle grow strong and healthy. It is a tough job, and no easier today than 200 years ago.

Today’s rancher must also be a veterinarian, a business person and an innovator. He or she must be able to fix a saddle as well as implement cutting edge technology to ensure that their products are as good, safe and wholesome as they can possibly be. And, they must also protect their families, juggling the responsibilities of parent-teacher conferences and little league games with cold nights and endless demands of the job. While the job of today’s rancher is vastly different than it once was, the values, toughness and integrity have endured.

As has been true since the unlikely beginnings of our great nation, strength, integrity and a willingness to persevere through anything to get the job done right, are the trademarks of today’s cattlemen. Thank you for a job well done. Today, we recognize you not just as American icons but also as Food Safety Heroes.

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The FDA’s Reportable Food Registry (“RFR”) has now been up and running for a full year.  So, has the RFR been successful?

As we discussed previously, the RFR is an internet based portal through which food manufacturers must notify the FDA of food products that have a “reasonable probability” of causing health problems or death in humans or animals. The RFR applies to any food product regulated by the FDA, with the exception of infant formula and dietary supplements.

This summer, the FDA issued a report on the RFR’s first seven months of operation, September 2009 through March 2010. Click on the following link to view a copy of the THE 2009 - 2010 FDA RFR REPORT.

During the first seven months, food companies submitted 125 “primary reports” through the RFR. A primary report is an initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators. Of those 125 primary reports, 122 were from industry, and 3 were from regulatory officials.

Also during that initial period, 1,638 “subsequent reports” were submitted as a result of a primary report. A subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted.

The FDA classified the 125 primary reports into seven food safety hazard categories, as illustrated in the pie graph below:

Percent Distribution of 125 Primary RFR Entries by Food Safety Hazard

        

Because this initial reporting period was so brief, the FDA wisely cautions that inferences cannot be drawn from this data. Nevertheless, the figures are still interesting.

More meaningful, however, is that of the 125 reports, only one caused a health problem – “an allergic-type reaction” in four family members. The FDA pointed out that all the reports had the potential to bring harm. However you want to interpret the fact that there was only a single health problem, it cannot be lost among the other numbers. Perhaps it highlights how the RFR brings an abundance of caution that will only make our food supply even safer.

And a meaningful statement was made by the FDA’s Deputy Commissioner for Foods, Michael Taylor. When asked how industry reacted to the RFR, Taylor said “The industry is taking it very seriously. They know it is a legal duty.” We are in a period of consumer distrust. I would like to share with consumers that not only does industry take food safety regulation seriously, I have personally experienced food manufacturers setting their safety standards above and beyond their legal obligation. Although recent media may suggest otherwise, our food manufacturers, with the exception of a few, care deeply about safety.

After just one year, it is too soon to determine whether the RFR will meet its goals of tracking patterns of adulteration and targeting the FDA’s limited inspection resources. The FDA has labelled the RFR’s first seven months “a success story.” It was not a perfect first year – the electronic submission process was already overhauled once; and questions still remain – how many of the potentially hazardous situations would have been reported under regulation in place prior to the RFR?

In any event, we will continue, of course, to answer your questions about RFR compliance and monitor new RFR developments.

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The FDA's Reportable Food Registry (“RFR”) first went into effect in September 2009. Since then, we have been watching closely the application and enforcement of the RFR.

At its core, the RFR is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).

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When I was growing up, going to a restaurant was a rare treat.

I would look forward to savoring a greasy burger and fries, or a steak and baked potato. Maybe I would even be fortunate enough to get soft serve swirled in a dish for dessert. Times have changed though. Today, one-third of all meals are eaten in restaurants.

I now travel quite a bit, so restaurants have become more of a staple for me. And, although all of us try as often as possible to dish up homemade food for our families, it’s not an easy task in today’s fast paced world. Thus, while I still look forward (on most days) to eating great tasting restaurant food, even if not the most nourishing, I also appreciate recent efforts to enhance the number of healthy choices on restaurant menus.

The President has already committed to enhancing our national food safety system through the Food Safety Working Group, and has supported new initiatives to educate consumers about the importance of food safety. And, now, the First Lady is tackling food nutrition and health. Indeed, last week, First Lady Michelle Obama addressed the National Restaurant Association ("NRA"). She called on restaurants to “create healthier versions of the foods we all love” and to decrease portion sizes. Fighting childhood obesity has long been a cause of Mrs. Obama, and her “Let’s Move” campaign aims to educate parents about nutrition, present healthier foods in schools, improve access to healthy food and increase physical activity.

Although none of us should tell restaurant owners what to offer on their menu, the First Lady did leave the NRA with some food for thought. Consumers have already been requesting more healthy alternatives, and assuming Mrs. Obama’s “Let’s Move” initiatives are successful, awareness and new demand will only increase. Obviously, restaurants want to continue serving up one-third (and perhaps more) of our daily meals.

In any event, I would like to commend the many restaurants that have already made great strides in providing healthy (and safe) food to their patrons. Thanks for giving us the choice between indulging in a treat or moderating in lighter, yet still tasty, fare.

With that said, it's lunchtime, and I’m going to go get a greasy burger and fries.

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How clean is your kitchen?

Probably not as sanitary as you think.

A recent study completed by the Los Angeles County Department of Public Health (“LACDPH”) found that only about 61% of home kitchens would receive an “A” or “B” grade if inspected like a restaurant, and at least 14% would flunk.

To put this in perspective, 98% of L.A. County restaurants received an A or B following inspections between 2006 and 2008, and any restaurants that failed were subject to closure.

There is an interesting background leading up to this study. If you have ever been to an L.A. County restaurant, then you have probably noticed a placard posted by the door with a fairly large A or B or crimson C. Beginning in 1998, L.A. County restaurants were required to display their health inspection grade to patrons. The result of this disclosure? By the end of 1998, the number of hospitalizations for food-borne illness was down by 13% in L.A. County.

The LACDPH enhanced these food safety efforts by introducing the Home Kitchen Self-Inspection Program in 2006 to encourage food safety practices in the home.

The program included an online Food Safety Quiz comprised of 57 questions developed around the USDA food safety principles of clean, separate, cook and chill. The quiz asked about food handling and preparation practices at home, but the questions were similar to the standards used to evaluate restaurants.

Approximately 13,000 adults voluntarily completed the quiz between 2006 and 2008; 34% received an A, 27% a B, 25% a C, and 14% failed. Thus, about one in seven homes deserved an “F” placard placed on their front door.

Granted, this study has some limitations. The quiz was only available online and in English. And obviously, the letter grades are based on respondent self-reports and not actual physical inspections of the home kitchens.

However, one such limitation makes the results even more frightening. People who are more interested in, and possibly more knowledgeable about, food safety were more likely to have taken the quiz. Letter grades aside,

• 64% of quiz respondents admitted that when cooking big portions of food to serve later, they did not rapidly cool and store it in a refrigerator;

• 36% of respondents did not have a properly working thermometer in their refrigerator; and

• 33% of respondents did not store raw meat below all other foods in the refrigerator.

Studies continue to evidence there is much more work to be done in educating our consumers. This study referenced how web-based learning tools (i.e. Meat Safety, Meat Matters Info, FSIS) are becoming ever more important in education.

In any event, I suppose, it’s fitting that the research was released during National Food Safety Education Month. Thus, moving forward, let's work to heighten awareness of food safety practices and help make not only the places we produce food, but also the places we prepare it, more sanitary and safe.

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This month marks the 15th annual National Food Safety Education Month!

The National Restaurant Association initially created National Food Safety Education Month in 1994 to enhance food safety education in the restaurant and food service industries. Today, food safety instruction is given special highlight each September by many sectors of the food industry.

This week the American Meat Institute (AMI) described its campaign aimed at educating consumers on the proper handling, cooking and storing of meat and poultry products. AMI released a 60-second radio piece nationwide, reminding consumers of the importance of meat and poultry thermometers and directing them to www.meatsafety.org. The radio piece can be heard here.

Developed by AMI, meatsafety.org offers safe handling guidelines and information on a variety of other topics such as food-borne illness statistics and food safety publications. Consumers can test their meat and poultry IQ on the site with a quiz (let’s just say I scored well). Meatsafety.org is a comprehensive site that also offers, among many other things, an overview of the U.S inspection system and AMI’s position on hot topics like antibiotics and meat myths.

AMI also built another great site, www.meatmattersinfo.org, to help consumers partner with them in food safety. Consumers can download the free brochure “Safe Handling of Meat and Poultry Products.” Further, AMI’s YouTube Channel, the Meat News Network, has many consumer-focused education videos, including video of safe handling practices.

In addition to the AMI, the following websites contain valuable materials to easily teach anyone about food safety and National Food Safety Education Month:

• ServSafe National Food Safety Education Month;
• FSIS Food Safety Education;
• Facebook – National Food Safety Education Month;
• Fightbac.org.

AMI consumer survey data indicated that only 34% of consumer respondents knew safe cooking temperatures, and only 1 in 5 consumers use a thermometer when cooking meat. These numbers are wholly unacceptable; consumers are the last line of defense against food-borne illness.

We applaud the the efforts of each of these initiatives, and remind everyone to boldly share their food safety knowledge.

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Eggs have been taking a lot of heat lately. The question, of course, is whether it could have been avoided.

Reviewing the most recent FSIS New Technology Information Table, I discovered that a number of the new additions pertain to egg products. And, in light of the recent developments (and scrutiny) involving eggs, there can be no doubt Professor Kevin Keener, of Purdue University, similarly hopes to see his own rapid egg cooling innovation embraced by regulators and industry soon.

Professor Keener has developed a process to quickly cool eggs to 45° (which significantly limits the ability of Salmonella to grow) after laying and processing. This is quite significant in light of the FDA research which Professor Keener cites: studies from the FDA show that if eggs were cooled and stored at 45 degrees or less within 12 hours of laying, there would be an estimated 78 percent fewer Salmonella illnesses from eggs in the United States each year.

The system involves placing eggs in a chamber with carbon dioxide gas at about minus 110 degrees. The cold gas circulates around the eggs and forms a thin layer of ice on the inside of the shell. The ice layer then melts and quickly lowers the egg’s temperature.

Not only does the cooling process have the potential to reduce food-borne illness, it is projected to increase egg shelf life by about four weeks. An extended shelf life also creates the potential opportunity for eggs to be exported. Professor Keener believes the technology can be easily integrated into large scale production without slowing operations, costing between two and five cents per dozen eggs.

The egg cooling technology thus far seems to be a winning proposition. Nevertheless, as scientists and industry continue to research and cultivate the best food safety defences, always remember that raw eggs must be properly handled and cooked.

And if you have not yet read my latest post at Meatingplace – Legally Speaking, please check it out: Salmonella: Surveying the science and sensationalism.

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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.

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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.

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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.

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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.

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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.

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This past December, FSIS and FDA jointly hosted a two-day public conference regarding Improving Product Tracing of Foods: More Rapid Outbreak Response.

While opening the conference, Jerold Mande, Deputy Undersecretary for Food Safety, called product traceability one of the most pressing challenges in food safety today. And, although the goal in any outbreak investigation to quickly identify and stop emerging outbreaks, Mande recognized that “finding solutions to increase the speed and accuracy of product tracing” will be very “difficult.”

FSIS held a second public meeting on product tracing in March (FSIS Product Tracing Related to E. coli O157:H7), specifically focused on two issues: (1) Agency procedures for identifying suppliers of source material used to produced raw beef product that FSIS has found positive for E. coli O157:H7; and (2) additional verification activities the Agency will conduct at suppliers’ facilities in response to positive E. coli O157:H7 results.

Obviously, the traceability issue is heating up, and everyone from farmers to packers to processors to retailers should keep abreast. Meat and Poultry B2B Data Standards Organization (mpXML) and GS1 US recently released a new guide for implementing product traceback minimum requirements and best practices. These materials are intended to supply all members of the U.S. meat and poultry industry, regardless of size, with enhanced guidance for tracing:

• Trading partners (your suppliers, your own company, your customers, 3rd party carriers);

• Trading locations (any physical location such as a warehouse, packing line, storage facility, receiving dock or store);

• The products your company uses or creates;

• The logistics units your company receives or ships; and

• Inbound and outbound shipments.

The guide was developed with meat and poultry suppliers, retailers and trade associations, and the USDA’s Agricultural Marketing Service.

Many industry stakeholders, including Costco, Perdue, Safeway, Tyson, Walmart, the American Meat Institute, and the National Chicken Council participated in the development. Doug Bailey, chief information officer of the USDA’s Agricultural Marketing Service, commented on the guide: “We view traceability as a component of an orderly marketing system, and this guide is a great example of industry collaboration to standardize the business processes that relate to traceability.”

As noted by Mande, traceability remains a “pressing” and “difficult” issue for all segments of the food industry. It is on the President’s agenda, the USDA’s agenda, and it impacts consumer confidence and health.  For this reason, you may find the new guidance materials helpful as you work to supplement or enhance your own internal practices.

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Many of the new technologies developed by meat and poultry processors must first be reviewed by the Food Safety and Inspection Service (“FSIS”) prior to implementation.

Processors are required to submit a written description to the FSIS of any new technology that could affect: (1) product safety; (2) inspection procedures; (3) inspection program personnel safety: or (4) would require changing existing regulations. FSIS, following its review of the processors’ submission, either notifies the processor that it has “no objection” to application of the new technology, or that it has concerns and will require additional information prior to any use of the new science. (See Guidance Procedures for Notification and Protocol Submission of New Technology).

FSIS has acknowledged that many “new technologies have resulted in significant improvements in the safety of meat and poultry in recent years.” The Agency also believes there will be even greater use and benefit from such technologies if they can also be shared with the public and industry. Therefore, FSIS makes available to the public a list of new technologies to which the Agency had no objections.

The FSIS New Technology Information Table contains a brief description of the technologies and names the companies which pioneered them. The list was just updated and contains all new technologies approved within the last 12 months.

If you have not yet added the New Technology Information Table to your “Favorites”, please do so. Meat and poultry processors are investing millions of dollars each year on the issue of food safety alone.

We, of course, can all gain by sharing and remaining abreast of food safety innovation.

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The Food Marketing Institute (FMI), in collaboration with Ecolab, has developed and released a new Norovirus Information Guide for industry.

As drafted, the Guide is intended to provide assistance to all types of food establishments in preparing for, and then reacting to, a potential Norovirus incident. Click on the following link to download a copy of the FMI Norovirus Guide.

Several FMI Food Protection Committee members actively participated in its development along with other professionals throughout the industry, academia and the regulatory arena.

With their collective input, direction and expert review, the FMI document reflects the most current Norovirus guidance for the food industry.

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Over the years, I have sampled numerous street food offerings in various cities throughout the U.S. More recently, I have been intrigued by news that certain street foods are both “going gourmet” and growing in popularity.

A few weeks ago, the Chicago Tribune reported on a new movement (spearheaded by gourmet chef Matt Maroni) to greatly expand Chicago’s street food scene (“Chef hopes to change Chicago laws barring gourmet food trucks”).

Unlike many other major cities, Chicago’s ordinances currently permit only pre-prepared and packaged foods to be sold on the street (i.e. hot dogs and popcorn). This is because there can be numerous potential hazards associated with the preparation of foods in mobile food trucks or stands. These include:

• If a food truck or stand is not parked close enough to a bathroom with a hand washing station, the food preparers could themselves contaminate food;

• If the food truck or stand runs low or runs out of potable water (which the truck itself must store in a tank), hands, utensils, equipment and food preparation areas may not be properly washed and sanitized;

• There is the potential for the truck’s power source to inadequately maintain hot and cold temperatures (especially during the heat of summer); and

• There is the potential for cross-contamination between foods such as raw meat and produce due to the limited storage and preparation space.

Recognizing the growing public interest in gourmet street food, however, chef Maroni is hoping to amend the regulations to allow preparation of fresh food made-to-order in a mobile food truck (i.e. flatbread stuffed with braised lamb, marinated tomatoes and a curry tzatziki).

In the amended ordinance he has proposed, Maroni does tackle the potential food safety concerns. And Elizabeth Gomez, director of outreach for Chicago alderman Scott Waguespack, a proponent of the ordinance, said “[w]e are taking our time to make sure that we are addressing public health and safety concerns [and] to ensure that we create an ordinance that will be successful in Chicago." Better technology, as well as commitment to food safety, can also reduce the risks in mobile food trucks. New state-of-the-art food trucks were showcased at the National Restaurant Association’s recent show in Chicago.

So, while we absolutely need to ensure that food (wherever prepared) is prepared safely, I will be watching the new ordinances with curiosity. And, chef Maroni’s braised lamb sure sounds good…

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Hamburgers and fries have long been a staple of both American diet and culture.

In recognition of that, President Barack Obama treated fellow world-leader, Dimitri Medvedev, to lunch at Washington’s favorite burger restaurant.

Ray’s Hell-Burger, a Washington hot-spot, is known for delicious, ten-ounce behemoths which are built from hand-trimmed, freshly ground beef. The restaurant is located in an unassuming storefront and boasts numerous B-movie posters and wooden tables outfitted with an assortment of condiments and a roll of paper-towels.

What did the two leaders talk about while consuming the all beef patties? Ironically, it was poultry. The men agreed, over their 10-ounce burgers, to resume poultry exports to Russia, overturning a ban that was put in place earlier this year. The dispute arose over the use of a chlorine rinse which Russia said violated its food-safety rules. Fortunately, the Washington burgers helped seal the deal, and poultry is now back on the menu. 

And, once again, a simple meal proves its worth in bringing the world just a little bit closer.

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Everyone feels sick about the vast amounts of oil continuing to leak into the Gulf of Mexico. And, for the last 2 months, it has been impossible to visit your favorite news site without cringing at the depressing headlines and photos.

Thankfully, however, in addition to the ongoing containment and clean-up efforts, our government and the seafood industry are working diligently to protect us from becoming ill (literally) from seafood tainted by the massive spill.

The Food and Drug Administration (“FDA”) is working with the National Oceanic and Atmospheric Administration (“NOAA”) and other federal and state agencies to monitor the safety of seafood from the Gulf. The agencies have issued several assurances to the public that their efforts should prevent any contaminated seafood from reaching our shores.

The NOAA’s first action was to swiftly close waters polluted by the oil spill to fishing and shellfish harvesting. NOAA has the authority to close Federal waters, and also works closely with the coastal states (who have authority to close waters within 3 miles of their shoreline). These closed areas continue to expand as the agency monitors the movement of the oil. A map of the closed Federal waters illustrates the enormity of the situation and its impact on our seafood industry.

The FDA affirms that “closing harvest waters which could be exposed to the oil is the best way to protect the public from potentially contaminated seafood, because it keeps the product from entering the food supply.” It has been over 60 days since the oil began pouring into the Gulf, and the well is still releasing as much as 2.5 millions of gallons of oil each day.

So, when will seafood from the region be safe again?

FDA and NOAA have a plan to answer this vital question. Under the plan, harvest waters will not re-open until oil from the spill is no longer present and the seafood samples from the area pass both sensory analysis by trained experts and a chemical analysis to ensure there are no harmful residues.
Some coastal food processing plants are still able to harvest product from Gulf areas not yet affected by the spill. These processors are complying with a surveillance sampling program just implemented by the FDA by providing samples of oysters, crabs and shrimp for pollutant testing. This current testing, and the analyses to be performed once waters are re-opened, will verify that the seafood on our tables is safe to eat.

On June 14, 2010, the FDA distributed a letter to seafood processors emphasizing the processors’ obligations under the FDA’s Fish and Fishery Products Regulation. Click on the following link to view a copy of the FDA Letter. FDA urges processors to verify that their HACCP plans account for the hazard created by the oil spill, and to reassess the plans as needed. FDA also advises processors on their duty to only process fish and shellfish harvested from waters that have not been closed. FDA and NOAA said they would increase inspections to ensure that processors maintain proper documentation on the origin of their products.

While we can feel confident in the federal food safety strategy to deal with this disaster, the full impact of this spill on the Gulf Coast seafood industry will not be known for years. Thirty percent of the Gulf of Mexico federal waters are currently closed, with no re-open date in sight.

AmeriPure, one of America’s largest suppliers of Gulf oysters, just temporarily closed its doors because it could not harvest enough to keep operating. AmeriPure is remarkable for the pasteurization-like process it applies to its oysters. The process does not affect quality, but leaves the oysters safe to eat. We applaud AmeriPure’s commitment to food safety, and extend our sincere hope to both the company and seafood industry that the well can be quickly capped and seafood, rather than oil, will once again begin flowing from the Gulf.

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Most food manufacturers, of course, hope that their persistent commitment to food safety will be enough to guarantee a safe product and completely eliminate any potential need for a future recall.

Despite such optimism, however, the possibility always exists (whether because of supplier issues or an internal problem completely unanticipated) that any company may someday be faced with an unexpected recall. For this reason, any food company that embraces a strong commitment to consumer safety, should also prepare in advance for the possibility of a product recall – no matter how remote.

We, of course, have worked with mutiple industry clients preparing for recalls, designing effective recall procedures, providing recall training, and managing crisis. We have also, in turn, worked closely with many clients through the late nights which follow the rare, but disappointing, realization that a voluntary and precautionary product recall may actually be warranted.

And, last month, I shared some additional perspective on crisis management and recall planning with Meatingplace (“Food Safety Attorney Advice For Companies Caught In A Recall”).  Moving forward, we plan to continue to offer our advice on these and other issues with contributions to additional print and electronic magazines such as the National Provisioner.  Watch for our monthly column begining in July 2010.

In addition to these existing and continuing contributions, a new industry report should further enhance our understanding of best practices for recalls. The report, “Recall Execution Effectiveness: Collaborative Approaches to Improving Consumer Safety and Confidence,” was conducted by Deloitte on behalf of the Food Marketing Institute (“FMI”), the Grocery Manufacturers Association (“GMA”), and GS1 U.S.

The FMI and GMA spearheaded the research because, for the reasons noted below, effectively managing recalls has become a “top priority for the entire industry:”

• Rising Number and Complexity of Product Recalls. The number of product recalls has more than doubled since 1999 (with the greatest increase in recalls linked to Salmonella contamination and undeclared allergens). The average cost of a recall to companies is $10 million, in addition to brand damage and lost sales.

• Growing Consumer Risk and Awareness. The consumption of raw products is increasing rapidly while the percentage of the U.S. population most at risk for foodborne illness is also increasing. A recent study found that 57 percent of consumers have stopped eating a particular food because of a food recall.

• Significant Impact on Share Price and Market Value. The study found that companies with poor recall execution processes could see stock price declines of up to 22 percent within two weeks after a recall announcement.

• Increasing Pressure From Trading Partners. Retailers are demanding a better recall execution process and given the number of recalls, are playing a more proactive role in quality assurance. As we reported earlier, Walmart set new standards for its beef suppliers.

In turn, the recommendations of the report cover three general areas: (1) communication and collaboration; (2) processes, organization and metrics; and (3) technology. Some of the communication initiatives include working with suppliers to conduct analysis on root causes of recalls, using multiple vehicles for notification of recalls (press releases, consumer loyalty cards, sales teams, etc…) and running mock recall exercises.

The report also urges companies to continuously refine their recall procedures, to strictly adhere to HACCP methodologies, and to invest early in employee training and planning for product replacement after a withdrawal. Finally, the report suggests that companies should also learn to understand and, to the extent possible, embrace new technology. In many instances today, recall processes are automated (and integrated) with systems such as the Rapid Recall Exchange and the Reportable Food Registry.

Ultimately, effective recall planning will remain a top priority for any company that manufactures and distributes food. In turn, we will continue to integrate many of these and other recommendations into our own planning guidelines. We will also be available to assist with your own recall planning and, whenever necessary, effective execution.

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Since its launch in September 2009, we've been watching closely the application and enforcement of the FDA's Reportable Food Registry (“RFR”).

According to the FDA, the purpose of the RFR is to provide a “reliable mechanism to track patterns of adulteration,” and “to target the agency's limited inspection resources where they're needed most.”

The RFR, at its core, is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).  They're a good read.

Ultimately, sharing helpful perspective and feedback with FDA today could help mitigate downrange confusion and, perhaps, even save your company from appearing in the RFR in the future.

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In late 2008, the FSIS announced that it intended to issue a Federal Register Notice to better explain the validation requirements under its HACCP regulations.

The Agency deemed this clarification necessary because of the “widespread lack of understanding of validation that FSIS has found among establishments, whether large or small HACCP in size or high or low in production volume, and because of the food safety problems that have occurred as a result.”

Unfortunately, the FSIS’s attempt to clarify has created some confusion and much concern. In the past year and a half, the meat industry and its trade associations have given considerable feedback to the Agency regarding validation. Even before the FSIS even issued its preliminary “Draft Guidance for HACCP System Validation” in March 2010, nine trade associations banded together to submit their comments to FSIS on the issue. Since opening the period for public feedback, FSIS has received almost 2,000 comments.

The thrust of the confusion and concern lies with the FSIS’s expectations for microbiological testing under the guidelines. Currently, the guidelines state that “establishments would need to provide support in instances where they believe microbiological testing data is not needed to demonstrate the effectiveness of the HACCP system in controlling biological food safety hazards.” Although the Agency has explained that the guidelines will not impose new microbiological testing requirements on establishments, there is distrust on the issue, particularly by small processors.

Some confusion has already been dispelled through the comment process, however, which highlights the importance of all processors – large and small – being well versed in the draft guidelines and the changes which need to be incorporated. Following an initial review of comments, the FSIS released a Fact Sheet addressing some concerns. The FSIS Fact Sheet confirmed that, among other things, no microbiological testing would be required for "well-established processes", and that establishments would only need to validate one plan per HACCP category.

The final day to submit comments on the preliminary draft guidance is Saturday, June 19, 2010. The Agency plans to complete a final review of the comments on the preliminary draft guidance and then issue an updated draft document in July 2010 for a second round of comments. The FSIS will also hold two public meetings regarding the updated draft.

Hopefully, the FSIS’s willingness to go through a lengthy drafting and comment process will result in true clarification and, ultimately, fewer of the food safety confusion which spurred the Agency to reevaluate its position on validation.

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Food manufacturers may soon have additional incentive to add yet another weapon – ultraviolet light – to their arsenal in the continuing battle against food-borne pathogens.

Meat processors already go to incredible lengths to clean and sanitize their facilities, but are consistently searching for newer and better technology to sterilize the plant environment. Unfortunately, bacteria such as L. monocytogenes (“Listeria”) can sometimes survive in trace amounts for extended periods in food processing facilities, even though processors dedicate a full shift each day to cleaning disassembled equipment, conveyor belts, walls, ceilings and floors with high-pressure steaming water and powerful sanitizers.

Cleaning aside, a new study published in the journal Foodborne Pathogens and Disease confirmed that Listeria contamination could be significantly reduced on a broad range of conveyor belt surfaces by exposure to UV light. In a controlled environment, researchers introduced the pathogen to conveyor belts made from four different materials and then studied the effects of UV light application at two different intensities and two different time intervals (one and three seconds). After application of UV light for three seconds, the bacterial counts were reduced to below detection levels on three of the belts, and the survival populations on the fourth were considerably diminished. Click on the following link to view an abstract of the Listeria UV Study.

Notably, Listeria has always created unique challenges for industry because of its ability to grow and survive over a broad temperature range. In addition to its natural ability to propagate in cold temperatures, it can also sometimes persist, and be difficult to remove entirely from, food product contact surfaces.

This inherent resilience, of course, can also have a significant economic impact for processors. In 2009, for instance, seven voluntary and precautionary recalls (involving over 45,000 pounds of meat) were announced as a result of possible Listeria contamination. And as we recently reported, the average cost to food companies for a single recall can range as high as approximately $10 million, in addition to potential brand damage and lost sales.

In any event, while researchers and industry continue to assess this promising new data regarding the potential efficacy of UV light on different product contact surfaces, the American Meat Institute Foundation (AMIF) is also inviting pre-proposals on research for controlling Listeria on ready-to-eat meat and poultry products.

Hopefully, such collective efforts will illuminate a clearer path to new and effective interventions designed to eradicate, to the best extent possible, these and other persistent food-borne pathogens.

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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.

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In the continuing battle to prevent naturally occurring microorganisms like E. coli O157:H7 from growing in cattle, researchers have discovered some promising new tools.

Although E. coli O157:H7 can cause illness in humans, the bacteria often exists as part of the gastrointestinal flora in healthy cattle. In turn, microbiologists at the University of Texas (“UT”), Southwestern Medical Center, working with the USDA, uncovered a mechanism which actually prevents E. coli O157:H7 from surviving in grain-fed cattle.

E. coli O157:H7 harbors a gene called sdiA, which makes the SdiA protein. When traveling within a cattle’s body, the SdiA protein senses a chemical made by microbes in the animal's rumen, the first of a cow's four stomachs, which serves as a large fermentation chamber.

Only after detecting this signal will the bacteria pass through the rumen and colonize in the recto-anal junction. By interfering with the SdiA protein (or, the genetic sensor), however, researchers were able to stop the bacteria from ever reaching the required colonization site. Notably, rather than colonizing, the bacteria simply died off, preventing any potential for future shedding or contamination.

"We're diminishing colonization by not letting pathogen go where it needs to go," said Dr. Vanessa Sperandio, associate professor of microbiology and biochemistry at UT Southwestern and senior author of the study. "If we can find a way to prevent these bacteria from ever colonizing in cattle, it's possible that we can have a real impact on human disease.” Notably, “[t]his could be something as simple as including some sort of antagonist in cattle feed, which would result in less shedding of the bacteria and less contamination down the road."

The findings, of course, are important because an estimated 70 percent to 80 percent of cattle herds can carry these pathogens. According to Dr. Sperandio, the finding “serves as a proof-of-principle that we might be able to target this system and help prevent food contamination."

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According to FDA, Caldwell Fresh Foods has announced a voluntary recall of alfalfa sprouts because of possible Salmonella concerns.

The alfalfa sprouts subject to the recall are labeled and packaged as follows:

• Caldwell Fresh Foods - 4-ounce plastic cups and one pound plastic bags, and 2-pound and 5 pound plastic bags in cardboard boxes with sticker affixed with the printed words Caldwell Fresh Foods.
• Nature's Choice - 4-ounce plastic cups
• California Exotics brands - 5-ounce plastic clamshell containers

The alfalfa sprouts were distributed to a variety of restaurants, delicatessens and retailers nationwide. In California, the products were sold at Kings Super Market, Numero Uno Stores, Cárdenas Markets, Trader Joe's Stores, Gonzalez Northgate Markets, Wal-Mart stores Jons Markets, and Canton Foods. Click on the following link to view the FDA Recall Release. 

Caldwell Fresh Foods alfalfa sprouts not affected by this recall will have a bright, round, green sticker affixed to the lids and labels.

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Agriculture Secretary Tom Vilsack has announced that the USDA will be issuing new performance standards designed to reduce the prevalence of Salmonella and Campylobacter in poultry.

According to Vilsack, this will be the first time the standards for chicken have been revised since 1996, and the first time the turkey standard have been revised since originally set in 2005.

In particular, the new performance standards will set the maximum positive rate for Salmonella in raw chicken carcasses at 7.5 percent, which represents a significant decrease from the current stanndard of 20 percent . The new performance standard for Campylobacter would allow roughly 46 percent of raw carcasses to test positive.

According to National Chicken Council spokesman Richard Lobb, a USDA baseline study from data collected from July 2007 to June 2008 showed an industry-wide 8.1 percent positive rate for Salmonella and a 40 percent positive rate for Campylobacter. For 2009, he said that the positive rate for Salmonella actually decreased to 7.1 percent. For this reason, Lobb explained that "the new standards are generally consistent with industry performance in recent years." In turn, Vilsack has indicated that the USDA hopes to have the new standards in place between July 1 and August 1, 2010.

In addition to unveiling the new performance standards, the USDA also announced that FSIS has developed the third edition of its compliance guide for poultry slaughter. Click on the following link to view the revised FSIS Compliance Guide.

The new guidance materials include additional and revised pre-harvest recommendations designed to assist processors in their continuing efforts to reduce these pathogens to the greatest extent possible. 

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According to the FDA, Freshway Foods has announced a voluntarily recall of certain romaine lettuce products because they have the potential to be contaminated with E. coli O145. The products were sold under the Freshway and Imperial Sysco brands.

The romaine lettuce products subject to the recall have a use by date of May 12 or earlier, and were sold by Freshway for food service outlets, wholesale, and in-store retail salad bars and delis. The products were sold to wholesalers and food service outlets in the following states east of the Mississippi river: Alabama, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia, and Wisconsin. The recalled romaine products were also sold for distribution to in-store salad bars and delis for Kroger, Giant Eagle, Ingles Markets, and Marsh stores in the states listed. Click on the following link to view a copy of the FDA Recall Release.

It is important to note, however, that bulk, prepackaged romaine or bagged salad mixes containing romaine that were purchased by consumers in supermarkets are not included in this recall; Freshway Foods does not produce these products.

The recall was announced quickly after FDA informed Freshway that a previously unopened product sample in a New York state laboratory tested positive for the bacteria. Freshway immediately traced the entire lot of romaine products, and is now advising customers to immediately cease use and distribution of any affected products. According to the CDC, although the investigation is continuing, affected lettuce may be linked to outbreaks in New York, Michigan, and Ohio. As of May 5, 2010, a total of 19 confirmed and 10 probable cases have been reported in these states.  Click on the following link to view the latest CDC Outbreak Report.

According to the FDA, Freshway has kept the agency and other public health authorities fully apprised of its handling of this matter, and it continues to cooperate with them to identify the cause. Notably, an extensive FDA investigation of Freshway’s facility in Sidney, Ohio has not uncovered any contamination at the plant.

In turn, Freshway Foods’ President, Phil Gilardi, stated that, although the company “practices strict food safety guidelines to ensure that its products are as safe as possible,” it promptly and voluntarily issued the immediate recall “to do everything possible to minimize any potential risk to public health."

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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.

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Research conducted by Dr. Barakat Mahmoud at Mississippi State University lends further credence to irradiation as another line of defense against foodborne illness.

Specifically, Dr. Mahmoud’s research found that x-ray irradiation killed harmful bacteria in certain foods without affecting the quality or freshness of the food, and the elimination of the bacteria even extended the food’s shelf life.

Through x-ray irradiation, Dr. Mahmoud eliminated the Vibrio bacteria from oysters without altering the quality of the food in any other way. In addition to seafood, Dr. Mahmoud’s research also focused on produce. Here too, x-rays destroyed the harmful bacteria in leafy greens but left the greens fresh and nutritious. Notably, leafy greens were deemed the riskiest food regulated by the FDA in 2009.

The notion of food irradiation has been around for quite some time, but it is not without limitations. X-ray irradiation, however, in comparison to gamma ray and electron beam radiation, may offer more promise. First, consumers are wary of irradiated foods even though irradiation has proven extremely safe. Dr. Mahmoud hopes consumers will feel more secure with x-ray technology since it is more familiar to them.

Second, the introduction of most types of irradiation into the food manufacturing process is not easily accomplished. Dr. Mahmoud does believe that x-ray irradiation “can be effectively used in large-scale commercial operations,” however, and is presenting his research across the country. Indeed, one advantage of x-ray irradiation is that it can be accomplished at the manufacturing facility, whereas some other technologies require trucking products to another location.

In any event, we send our thanks to the scientists, educators, government agencies and food manufacturers who continue their efforts to research new technologies -- like x-ray irradiation -- to help make the food we eat as safe as it can be.

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According to the CDC, incidence rates of E. coli O157:H7 decreased significantly in 2009 from recent averages, reaching the lowest level since 2004.

Moreover, for the first time, the number of reported cases actually fell below the federal 2010 Healthy People target of less than one case per 100,000 people.

As explained by Dr. David Goldman, assistant administrator of the FSIS Office of Public Health Science, the report “confirms our success in combating food-borne illness by setting an aggressive goal, designing an effective system to meet that goal, and [then] relentlessly implementing it.”

The most recent food-borne illness incidence data was collected and analyzed through FoodNet, a collaborative project including the CDC, USDA, FDA and various state health departments. FoodNet conducts active surveillance for nine pathogens, including Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella, Shigella, Vibrio and Yersinia. Click on the following link to learn how food-borne illnesses are tracked.

According to Dr. Chris Braden of the CDC, "the report indicates that there have been reductions in illness caused by many of these pathogens." Braden further explained that, “since FoodNet began surveillance in 1996, . . . [most] of the pathogens that we track have all declined."

And, while E. coli O157:H7 and shigella cases showed encouraging recent declines, the federal targets for Campylobacter, Listeria, Salmonella and Vibrio have not yet been met. Vibrio infections, for instance, increased by 85 percent compared with the first three years of surveillance, and Salmonella fell short of the goal.

Many Vibrio infections result from eating raw or undercooked shellfish, especially oysters. In turn, Salmonella is often difficult to combat because it can originate and spread from a wide variety of foods and environmental sources. In addition to foods, Salmonella has been associated with animals like baby chicks, small turtles, reptiles and frogs. And, as noted, while incidence levels for campylobacter and listeria continued to decline significantly, they still did not meet "Healthy People" targets.

In addition to the expected Senate passage of the Food Safety Modernization Act next month, the FDA is also moving forward with additional food safety initiatives aimed at decreasing food-borne illness. Dr. Jeff Farrar, the FDA’s associate commissioner for food protection, noted that the agency is still pursuing new requirements aimed at reducing the incidence of Salmonella during shell egg production. These initiatives are expected to become effective this summer, while FDA also works to develop a proposed rule which will likely include risk-based safety standards for produce.

If we are really serious about reducing food-borne illness, however, such initiatives and regulations are only one part of the overall equation. Much greater progress can likely be achieved – more quickly – if more consumers recognize the importance of properly handling and preparing raw animal foods. If all consumers can be educated to assume raw chicken, meat and eggs carry bacteria that can cause illness, to take additional precautions to avoid cross-contamination, and to cook all raw animal products to a safe temperature, consumers can significantly reduce their risk of becoming ill.

In this regard, better “Educated People” will more quickly and readily translate into far more “Healthy People.”

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A federal judge has dismissed a lawsuit filed last July by the vegan advocacy group Cancer Project asserting that hot dogs cause cancer.

The Cancer Project originally filed claims against several hot dog manufacturers on behalf of three New Jersey residents who alleged they were exposed to carcinogens by eating hot dogs — even though none of the plaintiffs had actually developed cancer.

In addition to money damages, the lawsuit also sought an order requiring hot dogs to bear the following label: “Warning: Consuming hot dogs and other processed meats increases the risk of cancer.”

Although a few studies have attempted to link processed meats with an increased risk of cancer by focusing on the potential health effects of nitrites used as preservatives, the fact remains that nitrates occur naturally in fruits and have actually been proven to improve health in many ways. In turn, numerous additional scientific studies, including one from Harvard University in 2004, have found no link between meat consumption and an increased cancer risk.

Concerned about the potentially frivolous nature of the claims, and citing the lack of scientific support for the allegations, the hot dog manufacturers promptly filed a motion to dismiss the lawsuit. On March 18, 2010, Judge Jose Linares, of the United States Federal District Court for the District of New Jersey, granted the motion and dismissed the case in its entirety.

"We are pleased that the court moved quickly and dismissed this lawsuit," said J. Patrick Boyle, president of the American Meat Institute. As explained by Boyle, Meat products are regulated and inspected by the USDA and bear the federal government's seal of inspection, showing they are wholesome and nutritious.”

And, Boyle is not the only authority on the matter. According to the U.S. Dietary Guidelines, processed meat and poultry products — including hot dogs — can be, and often are, a healthy part of a balanced (and, frankly, tasty) diet.

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According to the Center for Science in the Public Interest (CSPI), Hawaii ranks among the top states for food-borne illness surveillance, investigation and reporting. Other leading states include Maine, Kansas, Wyoming, Vermont, Alaska and North Dakota. Minnesota and Oregon are also regarded as having strong surveillance systems as well.

While many states ranked very high, however, some problems do remain.

According to CSPI, “some states may not have enough investigators or the money to train and equip their staff, which can lead to lower-quality investigations.” In addition to affecting the quality of such investigations, these and other limitations can also lead to mistaken conclusions regarding the source or cause of an outbreak.

CSPI also reports, however, the FDA Food Safety Modernization Act, which passed in the House of Representatives and is now pending in the Senate, will likely help improve national surveillance capabilities. If passed, the Act would require FDA to improve coordination between federal, state and local surveillance systems; develop a national network of laboratories; and improve epidemiological tools available to the states. The bill would also integrate food-borne illness surveillance with other bio-surveillance capabilities

Thus, as we strive to improve the safety of our food, as well as the ability of our food safety system to accurately detect and resolve emerging problems, we send our congratulations to the hard-working professionals in Hawaii and other states who are leading the way.

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Having visited numerous federally inspected meat processing plants, I can personally say that most of these facilities are far more sanitary than the average consumer kitchen.

Really, you ask? Is this possible? Well, yes. It is. And, it’s really pretty simple.

When was the last time, for instance, you steam cleaned your kitchen floor? How about the kitchen ceiling? How about the countertops? The cabinets? Both inside and out? How about the cabinet handles? Or, the outside of your refrigerator? Or, the walls behind and the floor underneath?

And, when was the last time you cleaned – and applied sanitizer – to the counter under the microwave? How about the underside of the microwave? Or the the cord and plug? Coffee maker? Fryer? Radio clock? Salt and pepper shakers?  How about the cat and the dog dish? Using plastic gloves, I hope.

And, when was the last time you completely emptied your refrigerator (or freezer), threw everything away, sanitized the surfaces with hot water (graced with robust chemicals), took microbiological samples, sent them  to an accredited lab, and then waited for the results to come back entirely negative before allowing any food to be replaced? And, what if we asked (or, forced) ourselves to do this every day? Although I may be wrong, I’m relatively certain most consumers would baulk at the idea.

Nevertheless, in meat processing establishments, a full shift each day is dedicated to cleaning and sanitizing the facility. All of the equipment (after disassembly), conveyor belts, walls, ceilings and floors are carefully showered with high-pressure steaming water, along with powerful sanitizers, designed to remove and kill any potential contaminants. And, once this eight hour shift is finished, and once all the equipment is reassembled, FSIS will not allow the facility to start making any food again until its inspectors conduct a thorough inspection and give their explicit approval. These inspectors, of course, remain in these facilities throughout the day.

On the other hand, we also know that most consumers spend little time thinking about the potential food safety dangers lurking in their kitchen. And even fewer take the time they really should to make sure everything is both sterile and clean.

Don’t get me wrong. This is not to say, of course, that consumers in all instances should be held to a higher standard than meat processors. I’m only saying that things should be kept in perspective. One way we can all work together to lower the incidence of food-borne illness is by bringing the cleanliness of our own kitchens to the same standard as many of the companies that supply our food.

In this regard, the following article authored by Jenilee Matz, M.P.H., a Staff Writer for www.myOptumHealth.com provides some great pointers:

Think your kitchen is squeaky-clean? Sure, it may appear spotless. But just because you don't see any crumbs does not mean your kitchen is sterile. Billions of tiny germs may have made themselves at home in your kitchen sink, on your counter tops, stove and everywhere else.

Germs live on every surface of your kitchen - from the buttons on the stove to your sink sponge to the coffee pot. But not all germs are bad. Good ones work hard in the digestive tract to keep us healthy. But others, like viruses that cause the flu and bacteria that cause food-borne illness, can make you really sick.

Washing your hands and wiping down counter tops are good first steps, but there's more you can do. Here are 10 tips for a germ-free kitchen:

1. Wash your hands properly. Use warm, soapy water and rub hands together for at least 20 seconds. Thoroughly scrub hands, wrists, fingernails and in between fingers. Rinse and dry hands with a paper towel and use the paper towel to turn off the faucet. Wash your hands:
   • Before and after handling food or eating;
   • After using the bathroom;
   • After changing diapers;
   • After handling animals and animal waste;
   • After touching something dirty (for example, after taking out the trash or using a tissue);
   • Before and after caring for a sick person;
   • Whenever they look [or feel] dirty.
2. Use paper towels to clean kitchen surfaces. Make sure to use them for one task only. Wiping down one surface and then cleaning another with the same towel can spread bacteria. If you use non-disposable cleaning cloths, clean them in the washing machine often. If you use sponges, microwave them each day for 30 seconds or wash them in the dishwasher. Germs grow when materials are moist.
3. Scrub your sink when cooking, especially if you are using it for different jobs while making your meal - like thawing chicken, preparing veggies and washing utensils.
4. Use hot, soapy water to clean your pots, cutting boards, dishes, utensils and counter tops before and after preparing food.
5. Sanitize all kitchen surfaces [at least] once each week for added protection against bacteria. Don't forget about door and cupboard handles, faucets and trash cans. Use a kitchen disinfectant or a diluted bleach solution (mix 1 teaspoon of bleach with 1 quart of water). The bleach solution needs to sit on the surface for about 10 minutes to be effective. Dry the surface with clean paper towels.
6. Clean your can opener regularly. This is an excellent place for germs to hide and grow. Wash it with hot, soapy water.
7. Disinfect the kitchen sink drain and disposal [at least] once or twice a week. Do so by pouring a diluted bleach solution (mix 1 teaspoon of bleach with 1 quart of water) down the drain. Bacteria can grow on food that gets stuck in the drain and disposal.
8. Clean the inside of your microwave and refrigerator once each week. Wipe up spills right away and clean surfaces with hot, soapy water. Once a week, go through your fridge and throw out expired foods.
9. Replace wooden items often. Wooden utensils and cutting boards can develop cracks where bacteria can hide.
10. Be extra diligent about cleaning when someone in your home is sick to stop germs from spreading. Wash your hands and surfaces more often.

In any event, following these simple steps can greatly reduce the risk and potential of contracting a food-borne illness. And although most consumers would likely feel that cleaning their kitchen for at least 8 hours each day may be a bit too much, we are hopeful some would agree that at least once a week is enough.

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Food manufacturers are constantly reminded about the nearly 76 million people in the United States each year who are affected by some type of food-borne illness.

In turn, many in the media – and elsewhere – often site these statistics to support misguided arguments that the safety of consumer food products is trending downward.

While improvements in national food-borne illness surveillance and reporting explain the recent increase in food product recalls and outbreaks, the reality is that with increased corporate and industry awareness, new interventions and emerging food safety technologies, the food we buy is the safest it has ever been.

What, then, explains the large number of annual food-borne illnesses?

People – not products.

Indeed, less cited statistics confirm that approximately 70 percent of food-borne illnesses (or, over 50 million cases annually) have nothing to do with the underlying safety of food. Rather, the majority of illnesses are caused by contamination where food products are prepared. As a result, if consumers and those who handle foods simply wash their hands, and prepare foods appropriately, most illnesses can be eradicated.

In turn, Dr. Peter Snyder, President of the Hospitality Institute of Technology and Management, advocates a simple solution. In a recent presentation, Dr. Snyder explains quite effectively how food handlers can exponentially reduce the risk of food-borne illness by following some very basic and simple hand washing techniques:

 

          

 

While we should never relent in our efforts to produce food that is as safe as possible, those who actually prepare and consume food also need to understand that the risks of food-borne illness can, in most instances, be virtually eliminated in the kitchen.

Thus, enjoy the presentation, and join us in giving Dr. Snyder a hand.

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It's no secret that virtually all foods are safe if handled properly.

Indeed, according to FDA, most food-borne illnesses are avoidable if consumers follow proper food handling techniques. This is true whether consumers are shopping for products, transporting them home or preparing them in their kitchen.

While proper handling and cooking is key, food safety starts at the grocery store. By following safe food handling practices while shopping, consumers can significantly reduce the potential for food-borne illness at home. In this Consumer Update video, FDA Consumer Safety Officer Doriliz De León guides consumers through a local grocery store while explaining how they can – and should – do their part to keep both their foods and families safe.

 

 

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Despite a national food safety system that has defined our food supply as one of the safest in the world, food-borne illness continues to impact many Americans. The CDC estimates that, each year, nearly 76 million people are affected by some type of food-borne illness.

In turn, given recent improvements in outbreak surveillance, more illnesses are being identified and more outbreaks are being reported. By extension, many outbreaks are being associated with an increasing number of variable sources, and more companies are – either directly or indirectly – being affected.

So, where can you turn when hungry plaintiffs’ lawyers or voracious government regulators come knocking? Reserve a spot at the table, and be sure join us at this year’s Food Law Specialized Law Group Session (“SLG”) during the DRI Product Liability Conference April 7-9, 2010 in Las Vegas.

The Food Law SLG is scheduled for the afternoon of Thursday, April 8, 2010, and will feature presentations on product warnings, packaging and claims defense. This year, I’ll be speaking about emerging food safety regulations now on the horizon. With an exceptional faculty, and smorgasbord of, well, delectable insight, we are truly looking forward to satisfying any appetite.

And, in case you were wondering, food isn’t the only thing on the menu at this year’s annual convention. In addition to presentations on food safety, the annual meeting also offers premier educational and networking opportunities, along with numerous general sessions and additional workshops designed to provide helpful insight across the entire product liability spectrum. Click on the following link to view the full DRI 2010 Product Liability Conference Brochure.

Thus, whether you’re in the mood for the latest in food safety, or product liability generally, the conference won’t disappoint. We are truly looking forward, along with all of our colleagues at DRI, to seeing you in Vegas!

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The recent hydrolyzed vegetable protein (“HVP”) recalls may force certain food processors to refine their product formulations which, by extension, could implicate current product labels.

To the extent that any ingredient revisions would force existing labels out of compliance, the FSIS has announced that an establishment should seek “temporary approval” for the continued use of existing labels. According to FSIS, the temporary approval will extend to any products in which HVP ingredients are removed or replaced with a non-allergenic substitute. Ultimately, the purpose behind the announcement is to permit establishments to exhaust their existing label inventory, despite the reformulation of potentially affected products.

To obtain temporary approval (which can be granted for a period of up to 180 days), food companies should submit their request to the FSIS Labeling and Program Delivery Division. According to the agency, any requests which clearly indicate they are a result of the HVP recalls will receive expedited review. Although establishments will still be required to submit information that demonstrates they meet the conditions for temporary approval set forth in 9 C.F.R. 317.4(f) and 381.132(f), the agency’s stated goal is to grant any such applications within 24 hours. Click on the following link to view the FSIS’ Labeling Guidance.

In the event food companies have any additional or specific questions regarding the FSIS labeling guidance, or to the extent they need any additional assistance, they are invited to call the FSIS Labeling and Program Delivery Division at (301) 504-0878 or (301) 504-0879.

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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

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For over a decade, we have worked throughout the country with food companies (including producers, distributors, restaurants and grocers) defending high-profile outbreak litigation.

In our years of experience, we have discovered that many claims lack merit, and many others prove questionable at best.

Because some investigators, most claimants and virtually all plaintiffs’ attorneys continue to adopt mistaken conclusions regarding the source of an alleged illness or outbreak, we are proud to offer the following Food Safety Litigation Library to assist with the investigation and defense of these claims:

 

• An Introduction to Food-Borne Illness Litigation;

• Chapter 1: Understanding The Role Of Government Oversight;

• Chapter 2: Understanding How Food-borne Illnesses Are Tracked;

• Chapter 3: Understanding The Speed Of Developing Outbreak News;

• Chapter 4: Responding To The Complaint - Procedural Considerations;

• Chapter 5: Understanding The Pathogen At Issue;

• Chapter 6: Understanding The Circumstances Of Plaintiff's Illness;

• Chapter 7: Obtaining Public Records Relating To Outbreak Investigations;

• Chapter 8: Understanding The Likelihood Your Product Was A Source;

• Chapter 9: Understanding And Identifying Alternative Sources;

• Chapter 10: Making Use Of Interrogatories And Document Requests;

• Chapter 11: Making Effective Use Of Plaintiff's Deposition;

• Chapter 12: Identifying Potential Experts;

• Chapter 13: Defending Damages.

 

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

Thus, when your company is faced with a claim, we truly hope the information provided above will enable you, too, to uncover the truth in food-borne illness litigation. 

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According to the FDA, Basic Food Flavors (of Las Vegas, Nevada) has announced a recall of hydrolyzed vegetable protein (HVP) paste and powder. HVP is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

The recall of HVP was announced following the discovery of Salmonella Tennessee in certain product samples, along with other samples reportedly collected at the company’s processing facility. In turn, Basic Food Flavors announced a recall all HVP in powder and paste produced and distributed by the company since Sept. 17, 2009. Click on the following links to view a copy of the FDA News Release and FDA Recall Information.

Although, to date, there have been no reported illnesses associated with the consumption of any food products affected by the recall, the FDA and CDC report that they are currently assessing and closely monitoring the potential risks of illness from affected products.

The FDA is also advising industry that any recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. Click on the following link for Product Handling And Reconditioning Information. Under the guidelines, FDA is allowing companies to recondition potentially affected HVP if thier processing contains protocols validated to inactivate Salmonella. 

Additionally, according to FDA, companies will not be required to recall any food products containing HVP if the products have validated cooking instructions which are sufficient to inactive Salmonella, FDA is recommending that any down-stream food companies that used HVP as an ingredient in food products which might be eaten by consumers without any further processing or cooking to address the potential risk, however, consider recalling such products. Under new FDA guidelines, certian companies may also have reporting obligations under the Reportable Food Registry.

In any event, additional information relating to potentially affected products can be found at www.foodsafety.gov.

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The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

For additional information on the registry and reporting obligations, please visit www.fda.gov/ReportableFoodRegistry.

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According to the FDA, Johnny's Fine Foods (of Tacoma, Washington) has announced a precautionary and voluntary recall of various French Dip Powdered Au Jus Products distributed to retail outlets nationwide.

The products subject to the recall include: (1) French Dip Powdered Au Jus in 6oz bottles; and (2) French Dip Powdered Au Jus in 1.1oz foil packets.

The Johnny's French Dip Powdered Au Jus 6oz is packaged in a clear plastic bottle with a red, white and blue label. The expiration date for this product is 0332. The Johnny's French Dip Powdered Au Jus 1.1oz is packaged in a red, white and blue foil packet. The expiration date for this product is 02212. Both of these products had been distributed nationwide and are sold in retail stores. Click on the following link to view a copy of the FDA Recall Release.

The recalled products were made using hydrolyzed vegetable protein manufactured by Basic Food Flavors (located in Las Vegas, Nevada). Basic Food Flavors initiated a recall of the hydrolyzed vegetable protein following discovery of Salmonella contamination during testing. It is also important to note, despite the issuance of a precautionary recall, that to date there have been no reported illnesses associated with the consumption of these products.

According to the company, the recalled products should be discarded. Additionally, consumers with any questions may contact Johnny's Fine Foods at 1-800-962-1462, Monday through Friday (8am to 3pm Pacific Standard Time).

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According to the FDA, Wholesome Spice (of New York) has announced a recall of crushed red pepper because of a potential link to illnesses associated with an ongoing nationwide Salmonella Montevideo Outbreak. As of February 24, there had been as many as 238 individuals from 44 states infected with the outbreak strain.  Click on the following link to view a copy of the most recent CDC Outbreak Report.

Wholesome Spice manufactured and then distributed the crushed red pepper to Daniel International for use in the production of various sausage and salami products which had been previously recalled by Daniel. Click on the following link to view Previous Daniel Recall Updates.  According to reports, a broad investigation into the source of the contamination was ongoing, and FDA recently discovered that samples of Wholesome Spice crushed red pepper had tested positive for the outbreak strain. In response, Wholesome Spice immediately announced a recall of all potentially affected products.

The Wholproducts subject to the recall include all lots of 25 pound boxes of Crushed Red Pepper sold by Wholesome Spice between April 6, 2009 and January 20, 2010.

The Crushed Red Pepper was packaged in a clear plastic bag, which was then placed inside a cardboard box marked with an adhesive white label containing a blue border and blue and black lettering. The brand name on the product labels is WHOLESOME SPICES. The product name is listed as CRUSHED RED PEPPER. The 25 pound boxes of Crushed Red pepper were distributed throughout the Northeastern United States. The product was not sold at the retail level or directly to consumers. Click on the following link to view a copy of the FDA Wholesome Spice Recall Release.

In a separate news release posted on the Rhode Island Department of Health website, David R. Gifford, Rhode Island's health director, noted that the recall “confirms that the source of the Salmonella was from outside of Daniele's manufacturing plants." According to additional reports, Wholesome Spice is currently working closely with FDA to determine how the contamination occurred.

In any event, manufacturers who may have purchased any of the recalled products are being urged not to use the products, and to recall any other products which may have used red pepper as an ingredient. Manufacturers with questions may contact Wholesome Spice via telephone at (718) 388-1549, Monday to Friday between 8:30-4:30pm EST.

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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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In a recent speech, USDA Deputy Under Secretary for Food Safety Jerold Mande outlined various areas of research he believes will help improve food safety.

During his remarks, Mande noted that he would like to push for more rapid and effective testing. "We need better sampling methods, along with tests that more rapidly detect a broader range of harmful pathogens," he said. "We also need stronger assurance that laboratories used by companies have the expertise and experience to do effective food safety testing."

In addition, Mande stated that FSIS inspectors should be given more sensitive and effective ways to detect food-borne hazards. Here too, Mande opined that the agency “needs to do a better job equipping our inspectors with the means to not let harmful pathogens slip by as we stand watch."

Next, Mande called for additional research to better identify what he referred to as “those unidentified pathogens” which could potentially be responsible for a majority of food-borne illnesses in the United States. According to the CDC, as many as 80 percent of illnesses, 70 percent of hospitalizations and 65 percent of deaths could be caused by agents other than the 30 pathogens CDC currently tracks.

Finally, Mande also suggested, and rightfully so, that additional research was needed to give farmers and ranchers better tools in order to fight food-borne pathogens. "To take the next big step forward on food safety we need to do more to have fewer pathogens on food animals when they arrive at the slaughterhouse gate," he concluded.

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Although most people believe that the decision to develop and utilize ground-breaking food safety technology rests exclusively in the hands of industry, this view is often mistaken.

Rather, the use of most new interventions that could immediately increase the safety of our food depends, not upon industry, but upon the approval of the federal government. And, when federal officials refuse or fail to act, both industry and consumers can suffer.

In 2004, the American Meat Institute (AMI) submitted a petition to FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of such technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

And yet, despite the obvious food safety advantages, the agency has for five years refused to approve use of the technology. To the surprise of many, agency officials announced in a recent meeting with the North American Meat Processors Association (NAMP) that no decision would be forthcoming soon.

Presumably, the reason carcass irradiation is an issue with FSIS is because AMI requested that it be approved as a “processing aid.” If the request was granted, processors would be allowed to use the technology without having to place special labels on meat processed with the intervention. Without specifying what, exactly, it was referring to, however, the FSIS stated simply that, “because of other recent events, processing aids in general are under greater scrutiny right now."

Although all of this may be true, with an increasing ability to detect food-borne illnesses and outbreaks nationally, the overall safety of food is under greater scrutiny as well.

In any event, carcass irradiation has often been cited by the meat industry as viable way forward in the fight against E. coli O157:H7 in ground beef. Keeping the word "irradiation" off labels, or even changing its description to something like "pasteurization," have been suggested as ways to increase public acceptance. This is because, previously, the use of low levels of irradiation to treat finished ground beef products fell flat, in large part, because the USDA required the use of a radura symbol on ground beef labels which simply scared the public away.

Frustrated by the lack of progress on its long-standing request, the AMI recently sent a letter to FSIS officials urging them to take action on the outstanding petition. FSIS then responded by saying the issue was being held up because it was waiting for the AMI to answer some of its queries on the petition. AMI, however, reported that it had never received any questions or concerns from the agency.

The controversy intensified last week when, as noted, FSIS informed NAMP of its intent not to grant the petition. When FSIS was asked to provide additional details regarding the continuing delay, it again stated that “AMI [still] needs to provide answers to [FSIS’] questions in order for FSIS to be able to act further on the petition.” Once again, however, the meat association denied being contacted by the FSIS, stating it had “received no formal response to [the] petition, including any questions or concerns that FSIS may have”.

AMI executive vice president James Hodges stated further that there was no reason to continue delaying evaluation of the matter. “AMI has submitted all information needed for FSIS to . . . publish a proposed rule regarding treating carcass surface irradiation as a processing aid”, he said. “Questions or issues about the technology [can be] best addressed through the rulemaking process that will be required to establish the parameters regarding applying this proven food safety technology. We look forward to a favourable response from FSIS.”

Having defended well-intentioned food companies for nearly ten years, and having witnessed the onslaught industry has received recently from media and congress for “failing to do more,” I am perplexed at the lack of urgency displayed by the agency. Perhaps this is yet another example of how government, rather than solving our problems, can often make them worse.

Thus, we too urge FSIS to take action on AMI’s proposal. If we truly want to advance food safety, we should start by convincing our government to advance those technologies that make it possible.

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Given recent improvements in national food-borne illness outbreak surveillance, more food-borne illnesses are being identified, and more outbreaks are being reported.

By extension, many of these outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected.

For nearly a decade, we have been defending food companies across the country in high-profile outbreak litigation (involving meritorious and non-meritorious allegations). During this period, we have also learned first-hand that when outbreaks do occur, not all investigations are performed properly, and not all resulting claims have merit.

Because of limited resources and other reasons, many outbreak investigations are still unable to identify the real culprit, and some continue to identify the wrong source. Unfortunately, in these and other cases,  many claimants (and their attorneys) continue to sue the wrong party.

Thus, when a food company is faced with an outbreak, it is critical to obtain experienced counsel counsel: (1) who understand how food-borne illnesses are tracked, investigated and confirmed; (2) who can help challenge developing assumptions and conclusions regarding potential source; (3) who can effectively respond to regulators and media during an outbreak and recall; and (4) who know how to properly defend food-borne illness claims and lawsuits when they do, indeed, occur. Over the last 10 years, our firm has written the doctrine on Defending Food-Borne Illness Outbreaks And Claims.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

In recognition of your incredible efforts to provide safe and plentiful food to our families, we are proud, when lawsuits are threatened, to protect and defend yours.

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Dr. Elisabeth Hagen has been selected to become the USDA’s newest Under Secretary for Food Safety. If confirmed, Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA's top priorities," said Vilsack. " Dr. Hagen brings the background, skills, and vision to lead USDA's efforts to make sure that Americans have access to a safe and healthy food supply."

The Food Safety mission of USDA includes the Food Safety and Inspection Service (FSIS), which is the public health agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

Dr. Elisabeth Hagen currently serves as the USDA's Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive at FSIS, where she played a key role in developing and executing the agency's scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level.

Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph's University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease. She is married and lives with her husband and two young children in Northern Virginia.

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According to the USDA, Daniele International (with operations in Pascoag and Mapleville, Rhode Island) has announced a voluntary and precautionary recall of approximately 1,200,000 pounds of sausage products which had been distributed nationwide.

The recall was announced as a precautionary matter, during the course of an ongoing CDC investigation into the source of a Salmonella Montevideo outbreak which has sickened hundreds in over 40 states.

Based upon analysis of preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of these illnesses and the consumption of certain sausage products. Some illnesses, however, showed no connection to Daniels or the products it processed. Nevertheless, although the investigation is ongoing, the CDC has posted information about the multi-state outbreak on its website. Click on the following link to view the most recent CDC Outbreak Report.

Because of speculation that the potential source of the salmonella in sausage products may be linked to contaminated pepper, the company elected to recall all products which may be potentially affected. Click on the following link to view the FSIS Recall Release. As the investigation continues, Daniels is working closely with state and federal agencies to help determine the most likely source.

JANUARY 31, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels has announced an expansion of its original January 23, 2010 recall. The expanded recall, involving approximately an additional 17,000 pounds of sausage products, was announced after the finding of Salmonella in certain samples of sausage not included in the original recall. Click on the following link to view the January 31, 2010 FSIS Recall Release.

FEBRUARY 4, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels announced a second expansion of its ongoing recall. The expanded recall, involving approximately an additional 23,000 pounds of sausage products. Click on the following link to view the February 4, 2010 FSIS Recall Update. FSIS has also published a list of all the retail locations to which these products were distributed and sold. Click on the following link to view the FSIS Retail List.

FEBRUARY 16, 2010 UPDATE:

The FSIS has announced another expansion of the recall originally issued on January 23, 2010.  The expanded recall was triggered after a finding by FSIS of salmonella in an unopened salami product, and involves an additional 115,000 pounds of products.  Click on the following link to view a copy of the FSIS Expanded Recall Release. 

According to the CDC, the outbreak currently involves over 230 people from 44 states. Ove these, approximately 44 people have been hospitalized, and no deaths have been reported. As noted above, however, some individuals have reported no exposure to Daniels or any of its products. For this reason, the CDC, FSIS, countless state and local health officials, as well as Daniels representatives, are continuing to work tirelessly to determine the most likely original source of the contamination. Click on the following link to view the most recent CDC Outbreak Report.

We, of course, wish them luck in their continuing endeavors.

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When I recently stood in for Mike Taylor as Keynote Speaker at the National Center for Food Safety and Technology annual meeting, I had no idea he would soon become the new Deputy Commissioner for Foods. The FDA created the new position, along with the Office of Foods, in August 2009.

As Deputy Commissioner for Foods, Taylor will help the FDA develop and implement a prevention-based strategy for food safety, plan implementation of new food safety legislation, and help ensure that food labels contain clear and accurate information on nutrition.

Taylor began his career as a staff attorney at FDA, holding various positions including deputy commissioner for policy. Taylor later served as administrator of the Food Safety and Inspection Service and acting under secretary for food safety at USDA. During his tenure, he initiated many reforms, including the development of comprehensive HACCP rules for meat and poultry processors and, through a policy statement, declaring E. coli O157:H7 an adulterant in ground beef.

Prior to becoming a senior FDA advisor in 2009, he served as a research professor at the School of Public Health and Health Services at George Washington University.

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According to the USDA, Huntington Meat Packing (of Montebello, California) has announced a voluntary and precautionary recall of approximately 864,000 pounds of ground beef products.

The following products, produced between February 19, 2008 and May 15, 2008, and January 5, 2010 and January 15, 2010, are subject to the recall:

• 40 lb. boxes of "Huntington Meats Ground Beef"
• 40 lb. boxes of "HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
• 40 lb. boxes of "BEEF BURRITO FILLING MIX"
• 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
• 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
• 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on the label. The products were shipped to distribution centers, restaurants, and hotels within the State of California. Click on the following link to view the FSIS Recall Release.

The problem was discovered during a Food Safety Assessment (FSA) by FSIS personnel. During a review of the establishment's records, FSIS determined that these products could potentially be contaminated with E. coli O157:H7. While these products are normally used fresh, the establishment announced a broader recall because of the possibility that some products could still be frozen and in commerce. Media and consumer questions regarding the recall should be directed to the company owner, Robert Glenn, at (888) 894-8242.

To date, there have been no reported illnesses associated with the consumption of these products. FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

FEBRUARY 12, 2010 UPDATE:

Based upon the results of an ongoing FSIS Food Safety Investigation, the agency has announced that the recall originally announced on January 18, 2010 has been expanded to include approximately 4.9 millions pounds of beef and veal products produced at the plant between January 22, 2009 and January 4, 2010.  Click on the following link to view the FSIS Expanded Recall Release.

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According to the FDA, Parkers Farm, Inc. (of Coon Rapids, Minnesota) has announced an expanded recall of various peanut butter, cheese and salsa and other products, to include all date codes, because they have the potential to be contaminated with listeria monocytogenes.

The recall, originally announced January 8, 2010, affected product with sell by dates of specific ranges. The expanded recall now includes all products and all sell by dates.

The recalled products were distributed nationwide in the following retail stores: Hy-Vee, Cub, Rainbow, Byerlys, Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop Rite, Nash Finch, Sams Club, Costco, Safeway, Kroger, Wal-Mart, Aldi. Click on the following link to view the FDA Recall Release and list of affected products.

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. The state of Minnesota, FDA, and the company continue their investigation into what, exactly, caused this potential problem.

It is also important to note that, to date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, the company is urging consumers who may have purchased these products to return them to the place of purchase. Consumers with questions can also contact the company at (800) 869-6685.

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The USDA's Agricultural Research Service (“ARS”) has announced that its scientists have developed two vaccines that might reduce the spread of E. coli O157:H7 in cattle.

"Preventing E. coli O157:H7 from proliferating inside cattle helps limit contamination of meat at the packinghouse, and reduces shedding of the microbe," ARS said in a statement. "Manure-borne E. coli can sometimes be moved by rainfall into drinking water. What's more, in some instances, it can end up in irrigation water, and can potentially contaminate fruits, vegetables and other crops, increasing risk of an outbreak of food-borne illness."

The first form of the vaccine is comprised of cells of a strain of E. coli O157:H7 that lacks a gene called hha. A second form of the vaccine contains an E. coli strain that lacks both hha and a second gene, sepB. In each of the vaccines the E. coli strain produces immunogenic proteins, which trigger an immune system response that prevents E. coli O157:H7 from successfully colonizing in cattle intestines.

In preliminary tests, 3-month-old Holstein calves were immunized with a placebo or either form of the vaccine. Six weeks later, the animals received a dose of E. coli O157:H7 and for the next 18 days, their manure was tested for evidence of the microbe. Calves that received either vaccine had reduced or non-detectable levels of E. coli within only a few days after being inoculated with the bacteria.

Research microbiologists Vijay K. Sharma and Thomas A. Casey developed the vaccines in their laboratories at the agency's National Animal Disease Center in Ames, Iowa.

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By Guest Blogger Cathy Crawford

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”

Consider, for instance, the recent recall of various canned Slim-Fast products. Unilever should be commended for its voluntary and precautionary actions. In this regard, it is critical to note that there were no illnesses associated with the consumption of these products. Rather, a potential food safety issue was identified internally by the company and then immediately reported. Thus, this is not a case that demonstrates the importance of, or need for, additional government oversight. Rather, this was a responsible company which, on its own accord, accepted the need to react, and did react, proactively to address possible food safety concerns.

Next, and even more important, is the size of the recall. Large recalls sometimes lead the media and consumers to believe that our great American food supply is unsafe. This recall, however, demonstrates just the opposite. For Unilever, it was likely that the exact cause of the potential problem was not immediately understood. Nevertheless, all of the potentially affected products involved in the recall were simply assumed by the company to be possibly – not factually – contaminated. In truth, there may have been one contaminated container, none, or many. Because the company wanted to react quickly, however, it initiated a very expansive recall, hoping the public would respect its actions, rather than judging it for having produced a suspect product.

Often, the behind the scenes, certain data driving the scope and limits of a recall are not fully available to the public. In turn, what consumers see or believe is only that a company released a food product later subject to a recall, and then had to have it returned so it could be safely discarded. What is rarely explained is that most of the food involved in any recall is completely safe. Because it can’t quickly be "proven" to be either safe or unsafe, however, it is voluntarily recalled, in an abundance of caution, to remove all potential risk.

If, or more likely when, recalls become “mandatory,” most companies will of course strive to comply with those requirements imposed by the relevant federal agencies. In doing so, however, some companies may become dependent upon federal regulators to define the scope of a recall, and thus overlook the opportunity to do more than what is being strictly required. Thus, although we may see routine compliance, we may also witness a potential loss in some of the extraordinary efforts taken by companies when they themselves voluntarily define the scope of a recall and go the extra mile in the name of public confidence and food safety.

Thus, in my view, additional and pointed regulatory power in such circumstances may not be the best answer. Instead, a coordinated effort to increase and enhance industry education may be a better long term solution. Imagine, for instance, the difference of having careful drivers in a school zone where the community uses education and training to instill an authentic sense of care about driving near schools. Compare this to a place where the time allotted for drivers’ education courses has been reduced, but drivers are expected to travel at 25 mph only because it is mandatory. In the end, which environment is safer? In which case are drivers likely to push the limit farther, and drive a bit faster, when no one is looking?

I would rather see additional resources diverted to increased awarness and training than simply trying to legislate a quick solution to a perceived problem by empowering and then expecting regulators to both define and then require “mandatory recalls.” Remember the drivers’ educational videos that may have scared you and convinced you of the power in your hands when at the wheel? Perhaps something similar, along with increased annual Hazard Analysis and Critical Control Point (“HACCP”) and food safety training, would do more for our system than additional legislation.

The food safety systems in many companies include HACCP protocols as well as systems in compliance with globally accepted food safety standards such as the Safe Quality Foods (SQF) or the British Retail Consortium (BRC). There are times when these systems might fail to identify or prevent a hazard. In these cases, however, responsible companies most often act proactively and quickly to implement corrective actions. Those actions include protecting the public, finding the cause of the problem, eliminating that cause, and updating internal systems to ensure any changes are effective. These things don’t happen without training. No legislation can replace that.

Nevertheless, a mandatory recall provision will likely pass. Without robust and effective food safety training at all stages in the food chain, however, this by itself will not likely diminish the need for recalls, nor will future recalls become any more efficient or effective.

* Cathy Crawford serves as a consultant with the HACCP Consulting Group (HCG), based in Fairfax, VA, just outside of Washington, DC.

HCG provides food safety consulting services to the food industry. Founded in 1994, HCG offers food safety training and assistance to both the FSIS and FDA regulated food industry as well as in over 35 countries that export meat and/or poultry to the U.S. Five of HCG’s 10 partners are former FSIS officials with the others from the food industry and state inspection programs. We have basic and advanced HACCP training courses accredited by the International HACCP Alliance in College Station, TX. HCG also provides Serve Safe training to the restaurant industry and has provided food safety training at a well know Culinary Institute. For more information about HCG please visit HCG’s web site at www.haccpcg.com.

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The USDA’s Food Safety and Inspection Service (“FSIS”) has announced the creation of a new help-desk, providing operators of small meat, poultry and egg processing establishments with access to knowledgeable specialists who can help them understand USDA directives, regulations and other information. The help-desk also will provide direct assistance to state and local food regulatory agencies.

"The FSIS is committed to providing assistance to businesses of all sizes that provide American consumers with access to a safe and healthy food supply," said Deputy Under Secretary for Food Safety Jerold R. Mande. "The small plant help-desk will help the development of small, local producers by offering a one-stop shop for questions about how to make sure their meat, poultry and processed egg products are safe, wholesome and properly labeled."

The new help-desk will support USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors to reduce the time and expense of dealing with agency requirements. "Know Your Farmer, Know Your Food" is designed to continue the national conversation about developing local and regional food systems and finding ways to support small and mid-sized producers. It emphasizes the need for a fundamental and critical reconnection between producers and consumers, building on the 2008 Farm Bill, which provides additional flexibility for USDA programs to promote local foods. More information on the "Know Your Farmer, Know Your Food" initiative can be found at: www.usda.gov/knowyourfarmer.

The FSIS small plant help-desk will serve as a "one-stop shop" for plant owners and operators with questions. More than 90% of the 6,000 plants inspected by FSIS are small or very small. FSIS staff will assess callers' requests and provide information and guidance materials that best meet their needs. In situations where the answer is not readily available, the staff will research the issue and follow-up with the caller. As appropriate, the help-desk will provide a portal to other services, such as AskFSIS, FSIS' existing service offering agency responses to inquiries on agency policy.

Inquiries can be made to the small plant help-desk by toll-free telephone or by email. The help-desk is open from 8:00 a.m. - 4:00 p.m. EST, Monday through Friday, excluding Federal holidays. To speak to a staff specialist during this time, call 1-877-FSISHelp (1-877-374-7435). You may also contact the help-desk by email at InfoSource@fsis.usda.gov.

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According to the FDA, Bao Ding Seafood of New York has issued a voluntary and precautionary recall of Boiled Horse Mackerel products because they have the potential to be contaminated with clostridium botulinum.

The processed products subject to the recall include Boiled Horse Mackerel packaged in a vacuum packed plastic bag, net weight 450g. The products were sold throughout New York State, and consumers should not use the product even if it does not look or smell spoiled. Click on the following link to view the FDA Recall Release.

The potential problem was discovered during a routine inspection and subsequent analysis of product by food lab personnel, which confirmed that certian fish had not been properly eviscerated prior to processing. To date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, consumers who may have bought the recalled products are being advised to return them to the place of purchase.

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2009 was a wonderful year for us at Defending Food Safety. From the launch of the blog only months ago, to speaking engagements in China, Mexico and coast to coast across the United States, we are lucky to have had the opportunity to meet and speak with so many about food-safety.

The coming year looks to see a lot of changes to the industry, both politically and regulatory. The outbreaks over the past year have thrust food-safety to the front of the national conscience and, with that attention, even the best, safest and most admirable companies will continue to be faced with new and emerging challenges.

The reality we face is that food is not sterile. We live, from a microbiological standpoint, in a dynamic world that is full of unseen and unforeseen dangers. The important thing is that we are prepared for contingencies and unfortunate events.

Having defended food companies for more than a decade—since the last century, in fact—we understand better than anyone the stress and hard work which goes into producing the food our families eat. That is why we are so proud to stand beside you in your times of need.

In addition to the broad range of litigation services we have historically offered, we are also now providing direct consulting to food companies across the nation who ask us to assess their food-safety protocols, to provide the tools and knowledge to improve them, and to minimize their exposure in the unlikely event of an outbreak.

We have also broadened our outbreak management capabilities to handle all aspects of crisis management. In the event of an outbreak, we will stand shoulder to shoulder with you, guiding you through the maze of your dealings with government regulators, the media, and the public. Our firm provides a wealth of expertise and experience that is unrivaled by any other in the nation. In your most difficult and trying times, we alone are suited to guide you smoothly and safely through the storms you may face.

We look forward to continuing our relationship with you over the course of the next year and beyond. We are also very grateful to those who have made 2009 a great year. We wish nothing but the very best to each of you and your families.

Again, as always, thank you for a job well done.

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In the past few years, the popularity of free-range poultry, pork and beef has increased dramatically.

It has been argued that, in addition to being a healthier and more humane way to raise animals, free-range food is better for consumers. And, although free-range foods tend to be significantly more expensive, consumers may not be getting what they bargained for.

One common justification for the increased cost is that free range food is healthier. A recent study published in the Journal of Foodborne Pathogens and Disease, however, found that levels of Salmonella, toxoplasma and even trichinosis were higher in free-range animals. This is likely because free-range animals are often exposed to a broader spectrum of environmental hazards than their counterparts, including a wider-variety of other animals, multiple water sources, diverse soils and even pathogens.

And, even setting health aside, many people insist that free-range animals taste better. Here too, however, studies have shown that in reality this might not be true. Research suggests that the increased price and altered perception of what is being consumed merely make people “think” that free-range necessarily equates to better quality (when, in many cases it does not). I am certain that, someday in the future, when we find ourselves eating meat produced in a test tube, there will undoubtedly be those who insist that meat coming from a living animal tastes far better, regardless of any actual differences. Food for thought, I guess.

In any event, the real issue at the “heart” of the matter may be the treatment of animals. Those who argue in favor of free-range farming do so, in most cases, because they believe the oft-publicized (and often incorrect) allegations of inhumane treatment of animals on large farms to be unacceptable. Although such arguments are noble, the fact remains that most animals for which we depend upon our survival are raised quite humanely, and free of pain and suffering.

In addition, few people know that there are currently no practical definitions or enforceable standards which dictate what it actually means to be “free-range.” In this regard, it is currently possible for an animal to characterized as “free-range” without ever having been outside. Simply allowing an animal access to the outdoors, even if for only five minutes a day, qualifies. Thus, the only way to really know how a particular producer raises its animals is to ask.

So, when you think about the health, taste and nobility of your next purchase, remember that, in many ways, free-range may not be so free.

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It’s been less than 12 months since we launched www.defendingfoodsafety.com. And, 2009 was, without question, a very interesting and dynamic year.

During the past year, we reported extensively on the PCA recall and fallout, analyzed pending legislation and regulatory initiatives, followed with interest the swine (or, H1N1) flu, tracked numerous emerging outbreaks and recalls, and introduced our readers to many fascinating food safety technological breakthroughs. Since entering the blogosphere, we have logged over 75,000 visitors, and we continue to attract more.

It’s been a great year, and we are thankful to everyone who continues to visit. And, before diving into 2010, here’s a quick survey of (only) some of the best from 2009:

1. The US Is Not Alone. No Matter Where You Live, Reports Of Food-Borne Illness Outbreaks Are Likely To Increase
2. Advance Series On Managing Food-borne Illness Outbreaks And Claims
3. Uncovering The Truth - Some Food-Borne Illness Claims Lack All Merit
4. From Drywall to Dry Foods - The Ominous Threat Posed By China
5. Do Some Consumers Really Relish Recalled Products?
6. 328.5 Billion Safe Meals (Not Including Snacks)
7. In Defense of the Rule of Law: Peanut Recall
8. Fast Food Saves Lives In Fruitland
9. Food Safety At 35,000 Feet
10. Not A Good Week For Pigs

Again, it’s been a great year for all of us at defending food safety. We, of course, wish you the same for 2010.

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According to the USDA, National Steak and Poultry announced a voluntary a precautionary recall of approximately 248,000 pounds of beef products.

Based upon preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of E. coli O157:H7 illnesses and the consumption of certain steak products. Many illnesses, however, showed no connection to National Steak or the beef products it processed.

Nevertheless, in an abundance of caution, the company announced a precautionary recall of certain products. Click on the following link to view a copy of the FSIS Recall Release. The investigation is continuing, and the original source of the contamination has yet to be determined.

FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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To our Readers:

It is our privilege to work with people who strive each day to create safe and wholesome food for our community.

We wish to thank them for all they do, and also to thank you for your continuing interest in the news and commentary posted here.

May you all have a safe Holiday Season.

All the best,

Ralph Weber & Shawn Stevens

     

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According to the FDA, Willamette Shelling has announced a recall of 114,350 pounds of shelled hazelnuts. To date, additional companies affected by the recall include Willamette Filbert Growers, Kunze Farms, and numerous other distributors and grocers nationwide.

The Willamette Shelling hazelnuts subject to the recall were shelled at a facility (located in Newberg, Oregon) for distribution to numerous down-stream hazelnut processors. Specifically, shelled hazelnuts distributed by the company were sent to various Oregon processors, along with a Canadian processor, and then further distributed by those firms.

All products subject to the initial Willamette Shelling recall were packed in 25 and 50 pound corrugated boxes, and marked with lot code numbers 296091A, 299091A, 300091A, VH3696BO, and 310091A. The corrugated boxes were also marked with the following brand names: Kunze Farms, Evonuk Oregon Hazelnuts, Canadian Hazelnuts, and Firestone Farms. It is important to note, however, that Willamette Shelling unshelled hazelnuts are not affected by this recall. Click on the following link to view a copy of the FDA Recall Releas (Willamette Shelling).

Willamette Shelling announced the recall immediately after learning that routine, random sampling confirmed positive for Salmonella in one of its hazelnut production lots. In turn, in an abundance of caution, and to ensure consumer safety, the company elected to voluntarily recall all shelled hazelnuts processed at its facility between October 12, 2009 and November 25, 2009. Thus, any hazelnut processors who used potentially recalled product are urged to return the product directly to Willamette Shelling.

As noted, the additional following downstream companies affected by the recall included Willamette Filbert Growers (of Newberg, Oregon), Kunze Farms (of Dayton, Oregon), and additional distributors and grocers located in Colorado:

• Contemporaneous with the announcement of the original recall, Willamette Filbert Growers announced its own recall of 29,861 pounds of potentially affected Shelled Hazelnuts and Shelled Organic Hazelnuts. The Willamette Filbert products subject to the recall were packed in 25 pound corrugated boxes, labeled with “Willamette Filbert Growers” or “Meridian Organic Hazelnuts,” and lot code numbers 289091A and 311091A. The hazelnuts were distributed in Oregon and California through wholesale distributors and for direct delivery. Here too, unshelled hazelnuts are not subject to the recall. Click on the following link to view a copy of the FDA Recall Release (Willamette Filbert).

Any customers who may have purchased Willamette Filbert Shelled Hazelnuts or Meridian Organic Hazelnuts are being urged by the company to return the product to the place of purchase for a full refund. Consumers with questions may contact Ben Mitchell at (503) 538-9256.

• Following the original recall announcement by Willamette, Kunze Farms also announced its own recall of 32,950 pounds of potentially affected hazelnut kernels. The Kunze Farms product was packed in 25 pound cartons, under the product brand name of Kunze Farms, ‘Select Shelled Hazelnuts’ Dayton, Oregon, with the code numbers 289091A or 299091A. The hazelnut kernels were distributed to several different processors and wholesaler’s in the following areas: Dayton, Oregon; Milton-Freewater, Oregon; Hauppauge, New York; Mesa, Arizona; Cottonwood, Arizona; Seattle, Washington; Ogden, Utah; San Antonio, Texas.; and Parker, Colorado. Click on the following link to view a copy of the FDA Recall Release (Kunze Farms).

In turn, consumers who may have purchased Kunze hazelnuts affected by the recall are being urged by the company to return the products to the place of purchase for a full refund. Consumers with questions may contact Kurt Kunze at (503) 864-2102.

The Colorado Department of Public Health has also identified additional companies that have been affected by the recall. Click on the following link to view the CDPH Hazelnut Recall Notice.

In Colorado, the recalled hazelnuts were sold by Mountain Man Nuts and Fruits Co. via the Internet, to numerous stores and sales distributors. Additionally, the product was distributed in Colorado to a variety of retail firms for bulk sale, including Whole Food Markets, Ft. Collins Food Co-op, Mountain Mama Natural Foods in Colorado Springs, and Healthy Solutions, in Denver.

All firms receiving recalled product have reportedly been notified, and the product is being pulled from shelves. Currently, the following additional products and lot codes are being recalled:

• Filberts, 289091A, 299091A;

• Natural Mixed Nuts, 32009, 33809;

• Fancy Mixed Nuts, 8- and 16-oz. bags, 30909, 31309, 31709, 32009, 32309, 32909, 33509, 33709 34209, 34309, 34809, 34909 35009;

• Choice Mixed Nuts, 16-oz. bags, 31309, 32709, 33609, 34909;

• Dry Roast Mixed Nuts,16-oz. bags, 30909;

• Sweet Simplicity™ Trail Mix, 32909;

• Mountain Jubilee® Trail Mix, 8- and 16-oz. bags, 31309, 32409, 33709, 34909;

• Cinnamon Almond Appleanche™ Trail Mix, 31009;

• Fancy Mixed Nut Gift Packs, 1.75 lb., all product, except 35009; and

• Fancy Mixed Nut Gift Packs, 1 lb., all product, except 35009.

According to the CDPH, products with these lot codes may also have been used as a component in certian gift baskets, including the 12 Tastes Basket, Bounty Basket and Half-Pound Sample Baskets. Moreover, given the potentially wide distribution of recalled product, additional recalls will likely be announced.

DECEMBER 23, 2009 UPDATE:

In addition to the specific recalls identified above, additional downstream companies have announced or expanded recalls of potentially affected products.  These include the following:

• Evonuk Oregon Hazelnuts:  View the FDA Recall Release.

• Harry and David:  View the FDA Recall Release.

• Whole Foods Market®:  View the FDA Recall Release.

• Burnt Ridge Orchards: View the FDA Recall Release.

• Market of Choice:  View the FDA Recall Release.

• Mountain Man Nut & Fruit Co.®:  View the FDA Recall Release.

Finally, it is important to note that, to date, there have been no reports of illnesses associated with the consumption of these products. Nevertheless, Willamette has ceased production and is working closely with FDA to investigate the issue, and will resume production and shipment  when any potential concerns have been resolved.

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Today, more than 15 percent of the food consumed in the United States is imported from foreign shores.  In turn, more and more cosumers are begining to question what is, and what isn't, being done to ensure the safety of foreign food product imports. 

In response, the Department of Homeland Security ("DHS") recently announced the creation of a new group, called the Import Safety Commercial Targeting and Analysis Center ("CTAC"), designed to enhance federal efforts to ensure the safety of imported foods.

Recommended by President Obama’s Food Safety Working Group, the new center will be staffed with about 30 members, will operate under the direction of Customs and Border Protection ("CBP"), and will receive direct assistance from numerous additional governmental agencies, including the FDA, EPA and CPSC. As one of CBP's six commercial targeting centers in the United States, the CTAC will target shipments of imported cargo, including food, for potential safety violations.

"In addition to guarding against terrorism and crime, securing our borders and facilitating legitimate trade involve ensuring the safety of imported [food] products," said DHS Secretary Napolitano. "This new targeting center will enhance the inspection of goods entering our country by centralizing and strengthening federal efforts to protect U.S. consumers."

Agriculture Secretary Tom Vilsack and HHS Secretary Kathleen Sebelius also backed the initiative. “With so much food coming from abroad, we must do all we can to ensure that it conforms to the same safety standards as our own food safety systems,” said Sebelius. “The new CTAC announced today is an important step toward the type of collaboration necessary to ensure that Americans have access to a safe and healthy food supply,” added Vilsack.

As part of its collaboration with CBP, FSIS will also extend its enforcement efforts to target ineligible imports, and investigate suspicious shipments based on manifest information filed prior to the arrival of goods at U.S. ports.

Ultimately, the new facility, which will be located adjacent to CBP's Office of International Trade in Washington, will strive to enhance the safety of foreign food product imports by promoting the three core principles announced by the Food Safety Working Group: Prevention, Surveillance and Response.

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The burger of the future may soon be here.

And, what's the burger of the future? Well, it’s a beef patty, actually. It will look, smell and taste the same as a burger does today. The only difference is that there may no longer be a need for the cow.

Technological advancements across the food industry, along with those in the bio-sector, have resulted in recent breakthroughs which could make artificial (or, in-vitro) meats available in grocery stores as early as 2012. Using embryonic cells to grow muscle tissue in a steel tank (imagine growing meat in a test tube), the process will likely be similar in many ways to yogurt production.

While the idea of eating artificially grown meat might seem somewhat "distasteful," the breadth of new incentives may eventually outweigh any potential consumer hesitance.

For starters, the meat of the future will be made to taste as good or, perhaps, even better than its naturally grown counterparts.

In addition to tasting great, it will also likely be healthier because scientists will be able to manipulate the nutritional content to optimal levels. Imagine a burger, for instance, that helps to prevent, rather than promote, heart attacks.

And, while promoting long term health benefits, lab grown meat, whether chicken, beef, pork or lamb, will be inherently safe. According to Jason Matheny of the research group New Harvest, the possibility of pathogenic contamination should become almost nonexistent. If we could produce meat in sterile conditions that are impossible in conventional animal farms and slaughterhouses, added Matheny, we could substantially reduce the number of food-borne illnesses and ancillary costs associated with outbreaks.

In a recent interview with CNN, Matheny also stated that Bio-meat could substantially reduce other human illnesses as well. These would include ailments "like swine flu, avian flu, and mad cow disease." Click on the following link to read the full CNN Report.

Beyond food safety, the financial benefits for companies producing meat without the expense of raising it are tremendous. It takes 700 calories of feed to produce a 100 calorie piece of beef. And, this does not take into account the other logistical problems of using meat off the hoof. “When we grow only the meat we can eat, it's more efficient,” said Matheny. “There's no need to grow the whole animal and lose 75 to 95 percent of what we feed it."

Ultimately, with lab engineered meat, food companies would no longer have to pay for raising, feeding, housing and providing veterinary treatment to live animals.

So, what’s a burger without the cow?

Perhaps a very "good" idea.

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According to the FDA, Unilever has announced a precautionary and voluntary nationwide recall of all Slim-Fast® ready-to-drink (RTD) products in cans.

The products affected by the recall are packaged in paperboard cartons containing four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. Click on the following link to view a List of Recalled Products.

No other Slim-Fast® products, including Slim-Fast® powdered shakes, meal bars or snack bars, have been affected by the recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Because possible issues involving Bacillus cereus, the company announced, in an abundance of caution, a precautionary recall of all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. Click on the following link to view a copy of the FDA Recall Release.

It is also important to note that, to date, there have been no reports of any illnesses associated with the consumption of these products. And, although Bacillus cereus in some instances can cause diarrhea and nausea, the possibility of serious illness or other significant health consequences is remote. Nevertheless, the company working to identify and correct any potential processing issues, and plans to resume production once they have been fully addressed and corrected.

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On November 17, 2009, Fairbury Steaks issued a voluntary and precautionary recall of fresh ground beef. The recall followed an announcement by FSIS that routine regulatory samples collected from the processor had tested positive for E. coli O157:H7. But, did FSIS make a mistake? And, was Fairbury wrongfully accused?

The sample collected by FSIS was taken from a 90 pound batch of finished product. The finished product was processed by Fairbury using frozen beef from another supplier. The frozen beef was sold to Fairbury with a certificate of analysis, documenting that it had been tested for E. coli, and that all tests were negative. In turn, all 90 pounds, once ground, were destined for a single Nebraska restaurant.

According to Dennis Brown, Fairbury’s owner, the ground beef collected for the routine FSIS sampling was collected from a single bag. The contents of the bag were then split in half – one half for FSIS and one half for Midwest Laboratories of Omaha (Fairbury’s own, third-party lab). According to Brown, Fairbury learned on November 14, 2009 that its sample was negative. Three days later, however, the USDA reported that its sample was positive.

What to do? Well, based solely upon its own testing, FSIS urged Fairbury to recall all 90 pounds of ground beef shipped to the Nebraska restaurant. Click on the following link to view the FSIS Recall Release.  And, although the company followed FSIS’ recommendation, Fairbury was not convinced that its meat was contaminated with E. coli.

To satisfy its own concerns, Fairbury recovered all 90 pounds of ground beef it had shipped to the Nebraska restaurant. The company then took samples from each of the nine packages that were returned, and had all nine samples tested by Midwest.

To assure the integrity of sampling, two FSIS representatives watched Brown cut open the nine packages of recalled beef, collect the nine samples, and then ship the samples to Midwest. In turn, all the samples from all the packages, plus a sample from a replacement shipment to the customer (which was included in the collection), tested negative for E. coli.

Although a negative result does not necessarily prove the absence of the pathogen, the numerous and multiple negative test results from the recalled product raise significant questions about the reliability and limits of regulatory testing, the potential for mistakes in governmental laboratories, and the amount of safe product companies are, in some instances, being asked to destroy. Although this recall involved only 90 pounds, the next may involve 900,000.

When asked about the contradictory test results, Brown admitted he's a bit confused. Given the number of negative samples from the recalled product, Brown believes that FSIS either had a false positive or there was cross-contamination in the government's lab.

Unfortunately, Neil Gaffney, a spokesman for FSIS, declined to comment on either possibility – including the history or extent of FSIS false positives.

Thus, in the absence of any response, it appears that the real answer in this case, like the ground beef that was recalled, could potentially have been a bit too much (for at least some) to swallow...

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Thanksgiving is, of course, a wonderful holiday. In addition to countless memories, it provides an unparalleled opportunity to share an incredible meal with friends and family.

Thus, in advance of the holiday, we simply wanted to take a quick moment to mention the efforts of those who have dedicated their careers to putting safe food on our tables.

At no time has food been as plentiful, affordable and as safe as it is today. This has not happened by accident, or as a result of luck. It has taken the constant dedication and tireless efforts of many, many individuals who, rarely, if ever get so much as a “thank you.”

The people we have worked with over the last decade care deeply about the quality and safety of their food. And, whether in California or Connecticut  – or any of the countless states we have visited in between – one thing always rings true. The people who provide us with the stunning bounty we enjoy are, hands down, good, caring citizens. Thus, our message is this: be proud of what you do, and know your efforts are appreciated. Especially today.

So... Thanks for feeding our families.  And, "Happy Thanksgiving" from all of us at www.defendingfoodsafety.com.

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According to the FDA, Timco Worldwide Inc. (based in Davis, California) has announced a voluntary recall of a limited number of Large Seedless Watermelons.

The Large Seedless Watermelons affected by the precautionary recall contain the “MelonUp!” sticker label, with a PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6. The watermelons were distributed to select grocers, wholesalers and processors in California and Texas. Click on the following link to view a copy of the FDA Recall Release.

Timco announced the recall immediately after learning that routine, random sampling by a distribution company confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all potentially affected products.

It is also important to note that, to date, there are no reports of illnesses associated with the consumption of these products. Nevertheless, consumers who may have purchased watermelons in the markets noted above (with the MelonUp! label) are being urged by the company to return them to the place of purchase for a refund. In turn, consumers with questions, or who need additional information, are invited to contact the company at 1-530-757-1000 (press “4” for Food Safety).

As with all fresh fruits and vegetables, Timco also recommends that fresh melons be thoroughly washed and rinsed before cutting and/or consuming them.

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According to the FDA, Five Crowns Marketing (based in Brawley, California) has announced a voluntary and precautionary recall of select cantaloupes packed under the Majesty label.

The cantaloupes affected by the precautionary recall were packed in various sizes with and without individual “Majesty” stickers. All cartons carry the label "Majesty," and are further identified with lot numbers 198 2 or 198 3, and pack dates of Nov 4, Nov 6, and Nov 10. Additionally, the cantaloupes in the identified lots were harvested and shipped to wholesalers, retailers, and food service operators in the states of Alabama, California, Illinois, Michigan, Minnesota, New York, Ohio, Oregon, Pennsylvania, and Tennessee. Click on the following link to view the FDA Recall Release.

Five Crowns Marketing announced the recall immediately after learning that routine testing on a lot of cantaloupes packed on November 4, 2009 confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all cantaloupe from the same lot.

It is also important to note that, to date, there have been no reports of illness associated with the consumption of these products. According to the company, most of the cantaloupes have likely already passed through the distribution chain. Nevertheless, the company continues to work with its customers to ensure that all of the potentially affected cantaloupes have been accounted for.

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According to the FDA, Service Smoked Fish Corp. (based in Brooklyn, New York), has announced a voluntary recall of certain Brooklyn's BEST brand SMOKED NOVA SALMON.

The Smoked Nova Salmon affected by the recall was vacuum-packed in clear, plastic bags of various size packages including 3 oz., 4 oz., 8 oz., 12 oz., 16 oz., and random weight sides with the brand name "Brooklyn's BEST" appearing on a circular label inside the vacuum bag. A "Use-By" date appears on the bottom of the gold board. Units with "Use-By" dates of 12/03/09 through 12/19/09 are being recalled. The product was also air-packed in bulk boxes. Air-packed units with lot numbers 060 through 043 are being recalled. No other use-by dates or lots numbers are involved in this recall.  Click on the following link to view a copy of the FDA Recall Release.

The Smoked Nova Salmon was distributed in the greater New York area, New Jersey, Connecticut, and the areas of Baltimore, MD, Los Angeles, CA, and Portland, Oregon. Consumers may have purchased the product from retail food stores.

The company announced the recall following the discovery of Listeria monocytogenes during routine product sampling. The company has ceased the production and distribution of the product, and is working with the FDA to investigate the potential source of the problem.

It is also important to note that, to date, there have been no illnesses associated with the consumption of these products. Nevertheless, consumers who may have purchased the above "Use-By" dates or lot codes of "Brooklyn's BEST" brand SMOKED NOVA SALMON are urged to return it to the place of purchase for a full refund. Consumers with questions, or who need additional information, are invited to contact the company at 718-388-4067.

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Sonia Johnson, a distinguished advocate for equal rights, once said “We must remember that one determined person can make a significant difference, and that a small group of determined people can change the course of history.”

In the past month, the Gass Weber Mullins’ Food Safety Defense Team has addressed more than a thousand food industry leaders in venues across the globe, on topics ranging from advancements in food safety technology to outbreak surveillance and food-borne illness litigation.

The 29th Annual Microbiology Symposium in River Falls, the American Conference Institute Food-borne Illness Litigation Conference in Chicago, and the National Center for Food Safety and Technology 2009 Annual Meeting, where Shawn Stevens filled in as Keynote Speaker for Senior FDA Policy Advisor Mike Taylor, are but only a few examples.

The distinguished members of Gass Weber Mullins, of course, have written the doctrine on Managing Food-borne Illness Outbreaks and Claims.

The utilization of emerging technologies to identify previously indeterminate sources of food-borne illness outbreaks, combined with broad expertise in national outbreak surveillance, media relations, government regulation and food-borne illness litigation, have cemented the firm's unsurpassed reputation as a food safety leader, and opened the door to speaking engagements throughout the United States and abroad. In the past few weeks, the firm’s food safety attorneys have also given presentations at the SQF Annual International Conference in Guadalajara, and the 3rd Annual International Food Safety and Quality Conference in Beijing, China.

Gass Weber Mullins strives, through hard work and determination, to recognize the valiant efforts of the hardworking individuals and food companies who work tirelessly, not only to put food on our tables, but also to improve the safety of our food. And, in a world marked by an increasing number of outbreaks, an escalating number of recalls, and rising number of meritless lawsuits, their mantra always has been, and always will be, "proudly defending the hard working Americans who feed our families."

When it comes to food safety litigation, Gass Weber Mullins leads the way.

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Scientists from the University of Missouri have developed a new method to detect live E. coli O157:H7 cells in ground beef.

Notably, the two-step method can distinguish between dead and living E. coli cells. The research uses a technique called a real-time polymerase chain reaction (PCR), a quick, reliable method for detecting and identifying pathogens in food. However, PCR can't differentiate living from dead microbial cells. Dead cells will not make people ill, and the presence of dead cells often results in false-positive findings, which can result in unnecessary product recalls.

To prevent this, researchers developed a method to stain samples with a dye called ethidium bromide monoazide (EMA). EMA cannot penetrate live cells, but it can enter dead cells. In the dead cells, EMA binds to DNA molecules, making them insoluble and therefore invisible to PCR tests.

The researchers have had success using the new technique on ground beef, chicken and eggs. Testing takes about 12 hours, compared with older methods, which require up to two days to generate results.

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An outstanding group of international food safety regulators, academics, industry leaders and top food safety lawyers are gathering in Beijing this week for a 2 day conference on food safety.

The Third Annual China International Food Safety and Quality Conference is designed to provide expert perspective on emerging industry trends impacting foreign food product imports, production and safety.

Speakers include Ge Zhirong, President, China Entry-Exit Inspection and Quarantine Association; Wang Yong, Minister, General Administration for Quality Supervision Inspection & Quarantine; David Tharp, International Association for Food Protection; Michael Pulch, European Commission to China, Bernard Kuhnle, German Federal Ministry of Food, Agriculture and Consumer Protection; Murray Lumpkin, FDA; Robert Charlebois, Canadian Food Inspection Agency; Art Liang, CDC and many, many more.

In turn, I will be speaking this year about the impact of food safety litigation in the United States on foreign food product production, imports and safety. Fellow food safety attorneys Bill Marler and David Ernst will offer additional perspective on food safety litigation at home and abroad.

More, of course, to follow.

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It is no small secret that our collective survival depends, quite literally, on the food we eat.

The availability and affordability of food has a direct impact on our individual health, along with (if we work in the food industry) the success and longevity of our careers. Indeed, if we produce food for others, the quality of the food we market and sell also affects our individual ability to provide for and feed our families. In this regard, every one of us (no matter how large or small our role may be) has an interest in making sure that the food we produce (and, ultimately, consume) is the safest it can possibly be.

To date, we’ve done an excellent job. Nevertheless, despite our best efforts, the existence of naturally occurring pathogens in our environment – and by extension in many foods – remains a real part of our business and lives. Given the limitations of science and, in no small part, consumer behavior, no one is immune. Every month, for instance, approximately 6,000,000 Americans will develop some type of food-borne illness. This also means that – each year– nearly one in every four Americans will be affected. Of these, approximately 325,000 individuals will be hospitalized, and nearly 5,000 could die.

And, no matter how much we care about food safety, this trend is not only likely to continue, but will likely accelerate. Given recent and substantial improvements in national food-borne illness outbreak surveillance, more food-borne illnesses are being identified, and more outbreaks are being reported. By extension, these outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected.

This resulting increase in reported outbreaks, along with a corresponding increase in media coverage, has also affected public and governmental interest in food safety. The politics of food safety, of course, translates exponentially into more regulation and a significant increase in food litigation. Thus, if your company has not yet faced a food-borne illness claim, chances are in the short term it will. Additionally, for this reason, businesses should begin contemplating how to best position themselves (from both a food safety and liability standpoint) to anticipate future problems, reduce company exposure, and react appropriately when an alleged food-borne illness or outbreak does indeed occur.

Not all food-borne illnesses claims, however, have merit. As noted, as a direct result of the growing public and political awareness in food safety, we have also witnessed an explosion in food-borne illness and outbreak litigation. In turn, we also know that, because of limited resources and other reasons, some outbreak investigations are still unable to identify the real culprit, and some continue to identify the wrong source. In these and other cases, many claimants (and their attorneys) continue to sue the wrong party.

Thus, here too, it is critical that food companies understand how food-borne illnesses are tracked, identified and confirmed, what to expect in a food-borne illness investigation, how to respond during an outbreak or recall, how to react when confronted with a potential claim, and how to properly defend their business and reputation when lawsuits are ultimately filed.

In any event, this is why we are proud to offer our Advance Series on Managing Food-borne Illness Outbreaks and Claims. For nearly a decade, our food safety team has helped food companies across the nation prevent litigation, manage crisis and defend claims (both meritorious and non-meritorious allegations). In the coming weeks and months, this series will provide additional and timely insight on what food companies can do to anticipate risk and reduce potential exposure, to effectively respond to and manage food-borne illness outbreaks and claims, and to effectively defend food-borne illness litigation and lawsuits when they do, indeed, occur.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

In recognition of the incredible efforts hard working Americans to provide safe and affordable food to our families, we feel inclined, when lawsuits overreach, to protect and defend yours.

Again, thanks for a job well done. And, welcome to www.defendingfoodsafety.com.

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Travelling throughout the United States and Internationally this week to speak at various food safety conferences (and mingling endlessly with numerous regulators and industry professionals), I continue to hear a common theme.

When it comes to the safety of our food here at home, it is intellectually healthier, if you will, to stand behind the teachings of science, than to be force-fed the frenzied rhetoric of cynics to whom things like perspective and reason are but tasteless, bland and easily ignored concepts.

Each year, American families eat somewhere in the neighborhood of 328.5 Billion safe meals – and countless more safe snacks. While any illness or death linked to the consumption of food is one too many, the fact remains that (at three meals a day) you and I are 20 times more likely to die this year from pneumonia or drowning than from a food-borne illness. Although not perfect, the statistics are quite impressive.

Mostly, the risk of eating is low because the hard-working people who actually grow, raise, manufacture, transport, process, prepare and serve our food – despite what you might be told by the media – are actually well-intentioned human beings. With incredible assistance and cooperation from numerous federal, state and local agencies, these hard-working individuals help make our food supply one of the safest in the world.

Included, of course, in this cast of thousands, are dedicated professions who work for numerous federal, state and local agencies such as the CDC, the FDA, the USDA, the FSIS, 50 individual State health departments, and countless local health departments. These individuals, in many instances volunteer extended hours at wages far below their true worth, working tirelessly to ensure that the food sustaining our nation is as plentiful and safe as it can be.

Yet, despite these incredible human efforts, both the food industry and government workers that oversee and track the safety of our food remain under continuous attack. As consumers, we are inundated by media “fear-mongering,” and made to believe that with each meal consumed, we draw closer to the precipice of some fathomless tragedy. We are also taught to be suspicious and wary of the people who have dedicated their lives to ensuring that our families are fed, and that our food is wholesome.

We are told of the ineffectiveness of federal, state and local regulators, alleged problems in food processing plants, restaurants and grocery stores, and how industry workers simply don’t care about the food they make. In order to believe this, however, we must ignore a fundamental truth: the food that our fellow Americans work so hard to produce is the same food they proudly feed to their families.

You see, food safety is a complicated and dynamic issue. It is easy to be a cynic. It is easy to attack others with the benefit of extended hindsight. It is easy to simplify things to a level that a third grader would find devoid in both substance and fact. The real challenge, however, lies in embracing a reasoned and proactive approach that not only recognizes the limits of technology and science, but, at the same time, within these limits, best reduces the risks most likely to occur to the greatest extent possible.

And, we must recognize, as well, that there are many sources of food-borne illness other than food products. More common than problems which occur at the highly regulated production level, are those which occur at the consumer level.

• How many offending foods, for instance, were perfectly safe until rendered unsafe by improper storage or handling?

• How many offending meals were perfectly safe until contaminated by ill food handlers?

• How many buffets at restaurants, churches, family gatherings or weddings were completely safe until contaminated by sick guests?

When we probe deeper, and actually balance the real and multiple causes of food-borne illness (most of which occur long after production), the safety of the food produced by industry is astonishing. And, frankly, until we recognize that each one of us shares responsibility for basic food safety in our homes, and until every food-handler, homemaker and guest can be rendered “sterile,” we also need to ensure that the laws regulating our food supply are driven by (and based upon) reality and science, not merely inflammatory rhetoric.

Nevertheless, many will continue to indiscriminately criticize our entire food system and, by extension, the countless people working to find solutions to the challenges we do face. And, although the same critics will also argue that consumers bear little responsibility for their own safety, please understand this is a dangerous and flawed philosophy which serves no one but those who profit from the sensationalism and mistrust they create.

In any event, for those who continue to ignore science and reason, who contend that food safety is the responsibility of food producers alone, and who wrongly proclaim that food safety is only as simple as “not eating poop,” I say this: given the statistics, what goes into one mouth is often far less harmful than what comes out of another.

*And, if you have any questions related to proper food handling, please feel free to peruse our site for safe handling instructions and tips; and, please encourage others to do the same.

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Food safety, of course, is a top priority for our nation’s food processors.

In addition to numerous other interventions, poultry processors also train employees to visually inspect carcasses for potential defects prior to final USDA approval.

This system of visual screening, however, is only as good as the human eye. Thus, in a continuing effort to push the food safety envelop even further, researchers have now proven that computer imaging can lend a helping hand.

The US Agricultural Research Service (“ARS”) has announced the development of an automated hyperspectral imaging system that can accurately detect food safety and quality defects (including small amounts of fecal contamination) on poultry carcasses. Hyperspectral imaging is a technique that combines digital imaging with spectroscopy, creating individual wavelengths of light that pinpoint contaminants.

The new system was developed, in conjunction with Stork Food Systems, by ARS scientists at the Quality and Safety Assessment Research Unit in Athens, Georgia. Notably, a prototype was recently tested in a poultry plant to evaluate its performance under commercial conditions. In the trial, carcasses were imaged after evisceration (but prior to washing) at a rate of 150 birds per minute. According to reports, the system ran successfully for several days. Nevertheless, while the initial trials showed great promise, researchers are still working to refine the system to better avoid false-positives.

The ARS researchers are also collaborating with the Environmental Microbial and Food Safety Laboratory in Maryland, which has developed a similar on-line system designed to differentiate diseased poultry carcasses from those that are wholesome. The system relies upon the same imaging technology, but uses different wavelengths.

In any event, the two groups are now attempting to merge the systems into a single unit, which will include an imaging camera and detection software. According to reports, the team plans to have a prototype of the joint system ready for further trials later this year.

Congrats to all.

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With Halloween fast approaching, it would seem the perfect time to worry the masses.

Researchers from the Center for Science in the Public Interest (“CSPI”), for instance, have just compiled nearly twenty years of CDC data, and used it to create a list of the riskiest foods to consume. In turn, some major news outlets, including CNN, quickly publicized the findings. Click on the following link to view the CSPI Study.

The study attempted to determine the relative risk of select foods by examining the frequency of past food-borne illness outbreaks associated with each. The findings, ironically, are nearly identical to the Food Guide Pyramid, which tells us what, and how much, food we should eat in order to stay healthy.

In any event, according to the CSPI study, the ten most risky foods are as follows:

1. Leafy Greens: 363 outbreaks (13,568 reported cases of illness);
2. Eggs: 352 outbreaks (11,163 reported cases of illness);
3. Tuna: 268 outbreaks (2341 reported cases of illness);
4. Oysters: 132 outbreaks (3409 reported cases of illness);
5. Potatoes: 108 outbreaks (3659 reported cases of illness);
6. Cheese: 83 outbreaks (2761 reported cases of illness);
7. Ice Cream: 74 outbreaks (2594 reported cases of illness);
8. Tomatoes: 31 outbreaks (3292 reported cases of illness);
9. Sprouts: 31 outbreaks (2022 reported cases of illness); and
10. Berries: 25 outbreaks (3397 reported cases of illness).

The implied lesson from the findings seems to be that we should, in order to minimize our risk of getting sick, avoid eating fruits, vegetables, dairy products and seafood. In turn, it would seem, a diet which consists strictly of beef, chicken and candy would be exactly what the doctor ordered.

In my view, scaring people away from certian foods doesn’t help promote food safety. And, warning people not to eat fruits and vegetables may be a bit short-sighted. Leafy greens, for instance, are served in virtually every single salad and on every single sandwich; that translates to nearly a billion safe servings every single day. The same is true for other foods on the list, including countless fruits and most vegetables.

So, in twenty years, we have less than 14,000 reported cases of people getting sick from leafy greens? You do the math. This is really no different than arguing that visiting the grocery store (to buy your produce) is an inherently dangerous activity because, every so often, someone trips.

Moreover, in my house, it is not what you eat that determines the risk, but rather who made it. My father, for instance, didn’t stop at just cooking our food. He cremated it. In this regard, most foods we enjoy are perfectly safe when properly handled and cooked to a thousand degrees centigrade (or, 160 degrees fahrenheit as recommended by FSIS).

In any event, recognizing that nothing in our world is without risk, I’ll continue to take my chances with a healthy diet and tasty food. And, despite its safety record, the candy can wait until Halloween. For now, I’m going to go eat a salad.

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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.

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The Food Marketing Institute (FMI) and GS1 US have announced the launch of a new online service designed to facilitate the prompt exchange of accurate recall information between retailers, wholesalers and suppliers. When recalls are announced, the new system, known as the Rapid Recall Exchange (“RRE”), will allow suppliers to send specific, targeted information to retailers and wholesalers on how to remove recalled products, handle them safely and address reimbursement requirements.

According to the FMI, the new system was designed by the industry for the industry. The RRE replaces the existing Product Recall Portal, improves ease of use and adds numerous capabilities. In addition to complimenting existing recall practices and complying with the requirements of the FDA Reportable Food Registry, the RRE also features:

• Secure user-authentication;

• Two-way messaging between trading partners;

• Internet access anywhere, anytime;

• Email alerts about new information;

• Comprehensive, prioritized information with U.P.C. bar codes and product images for easy identification;

• Verification of notification;

• Universal notification of Class 1 recalls;

• Targeted notification to specific customers;

• Consistent, reliable communications; and

• Standardized forms, processes and instructions applying industry best practices

According to Bob Carpenter, CEO of GS1 US, the new system “will ultimately benefit the public as well as the companies that use it.” In turn, access to the Rapid Recall Exchange is available for a nominal fee imposed only to cover operating expenses.

To encourage quick and widespread adoption of the system, FMI and GS1 US are also offering free trial subscriptions to retailers and wholesalers that sign up by Oct. 30. The trial period runs through Dec. 31, 2009.

More information is available at www.rapidrecallexchange.org.

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It seems that the world has gone crazy for bacon.

Certainly I have always enjoyed it. Perhaps I even indulge in it more than I should. I have no problem sitting down to a plate of bacon with my eggs in the morning. I like it on cheeseburgers and wrapped around scallops.

I also saw that the Wisconsin State Fair was selling chocolate covered bacon this year. That seemed to be a stretch, but I tried it. It tasted like chocolate and bacon. I even came across bacon flavored vodka recently. I didn’t try that, though I imagine it would probably taste; well, like bacon and vodka.

The weirdest bacon laden food I have yet heard of is bacon and egg ice cream. This no doubt delectable treat can be found only the menu of The Fat Duck restaurant in London. Other menu items include powdered pigeon, jelly of quail and salmon poached in liquorice.

Another specialty dish, now off the menu is shellfish ala pickle. According to the Health Protection Agency, the restaurant unknowingly (and, quite innocently) received a shipment of shellfish last February that had been contaminated with norovirus. Unfortunately, five hundred sick patrons caused the restaurant to shut down.

The Health Protection Agency released its final report last month, which noted that a total of 529 diners ultimately reported symptoms of vomiting and diarrhea in the weeks following the start of the February 2009 outbreak. The report also said restaurant employees who had been hit by the virus may also have returned to work before they had fully recovered. With powdered pigeon on the menu, it must have been nearly impossible to keep them away.

In any event, The Fat Duck maintains it is not liable for the outbreak, and also insists it followed all food hygiene procedures correctly. Notably, investigators agreed, concluding there were no breaches of hygiene at The Fat Duck. And, in the defense of the restaurant, it is very well known for the high quality food it serves and also its cleanliness. It has been given three stars by Michelin, and has received numbers awards and accolades.

The head chef, Heston Blumenthal, has also written a letter of apology to those patrons who fell ill and invited them—when the time is right—to come back and give the restaurant another go. He stated in the letter that, "It was deeply upsetting to all of us that your enjoyment of The Fat Duck was not as we had intended it to be, I would be delighted if you would consider returning to The Fat Duck at a time that is convenient to you."

So, on your next stop in London, I would strongly recommend visiting The Fat Duck. Although shellfish may no longer be available, nothing beats the powdered pigeon or jellied quail, capped -- before the check -- with a delectable serving of bacon and egg ice cream.

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According to the California Department of Public Health, Ippolito International (based in Salinas) has announced a voluntary and precautionary recall of select “Queen Victoria” and “Tubby” bunched spinach.

The spinach affected by the precautionary recall was packed in 12-count and 24-count spinach bunches in cardboard boxes with “Spinach” printed on the side panel, in wire bound crates or reusable plastic containers. The cartons of recalled spinach were also labeled with the following Code Date Stickers which can be located on the outside edge panel of the carton:

• 10522441 5 205 (harvested September 1, 2009);

• 10522451 5 205 (harvested September 2, 2009);

• 10522461 5 205 (harvested September 3, 2009).

The Tubby label was packed only on Code Date 10522451 5 205.

In turn, the individual 12-count and 24-count spinach bunches were bound with a twist tie which says “PLU 4090 UPC 33383-65200.” The twist tie associated with the “Queen Victoria” label has the Queen Victoria logo on it. The twist tie for the Tubby label has a generic spinach band on it.

Of the 1,715 cartons of bunched spinach recalled, a total of 1,515 cartons were packed under the “Queen Victoria” label and distributed to California, Alabama, Arizona, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Minnesota, New Jersey, New York, and to British Columbia, Ontario, and Manitoba in Canada. The remaining 200 cartons were packed under the “Tubby” label and distributed in California and New York. The recalled spinach was distributed to retail, food service and wholesale buyers.

Ippolito International immediately announced the precautionary recall following the discovery of Salmonella during routine product testing. It is also important to note that, to date, there have been no illnesses associated with the consumption of these products. Nevertheless, consumers who purchased these products should discard them or return to the place of purchase for a refund. Consumers with questions, or who need additional information on where the recalled products were sold, are also invited to contact Ippolito International at 1-831-772-9991.

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The USDA has published new rules for a proposed program, under which select State-inspected establishments (with 25 or fewer employees) will be eligible to ship meat and poultry products in interstate commerce. Click on the following link to view the Proposed Rule.

The new program was created as part of the 2008 Farm Bill to supplement the existing Federal-State cooperative inspection program to allow State-inspected plants with 25 or fewer employees to ship products across State lines. This announcement is part of the USDA's new Know Your Farmer, Know Your Food Initiative, which seeks to better connect consumers with local producers to help develop local and regional food systems to spur economic opportunity.

"This new cooperative interstate shipment program will provide new economic opportunities for many small and very small meat and poultry establishments, whose markets are currently limited," said USDA Deputy Under Secretary for Food Safety Jerold Mande. "We can provide new markets for these establishments, while maintaining the integrity of the Federal mark of inspection."

Currently, 27 states operate State Inspection Programs for meat and poultry, and FSIS verifies that the State programs are implementing requirements that are "at least equal to" those imposed under the Federal meat and poultry products inspection acts. Click on the following link to view the Current List of Qualifying States. For these programs, FSIS provides up to 50 percent of the State's operating funds and provides oversight and enforcement of the program.

Under the proposed rule, selected establishments will receive inspection services from federally trained and/or supervised State inspection personnel who will verify that the establishments meet all Federal food safety requirements. Meat and poultry products produced under the voluntary cooperative program will bear an official USDA mark of inspection, thereby enabling interstate shipment of the products.

State-inspected establishments that are not selected for the voluntary cooperative program, including state-inspected establishments with more than 25 employees, are only eligible to sell and ship their products within their State.

Comments must be received on or before Monday, November 16, 2009, through the Federal eRulemaking Portal at www.regulations.gov, by mail to: FSIS Docket Room, USDA, FSIS, OPPD, Docket Clearance Unit, 5601 Sunnyside Avenue, Stop 5272, Beltsville, MD 20705.

All comments must identify FSIS and the docket number FSIS-2008-0039. Once received and published, interested parties will be able to View All Comments Online.

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According to the FDA, Muranaka Farms has announced a voluntary recall of 1005 cases of 60 count bunched Parsley because it has the potential to be contaminated with Salmonella.

The recall was trigged as a result of a voluntary sampling program conducted by the California company in cooperation with the FDA, which revealed that certain finished products could potentially contain the bacteria. Click on the following link to view the FDA Recall Release.

The specific products affected by the recall include 60 count fresh bunched parsley Lot Code 0023909. The products were shipped in a brown wax carton under the Muranaka Label with a parsley silhouette on the side. In turn, individual parsley bunches were banded using a red rubber band. The lot code 0023909 is on a sticker on the outside of the carton.

The affected products were distributed in the following 10 states: Arizona (30 cases), California (574 cases), Colorado (35 cases), Florida (60 Cases), Iowa (3 cases), Illinois (1 case), Missouri (7 cases), Tennessee (5 cases), Texas (278 cases) and Wisconsin (12 cases). These cases were distributed within both retail and foodservice outlets.

Because of Muranaka Farm's trace recall program the company was able to immediately determine which customers purchased the product in question. Muranaka's food safety protocols also ensure the company was able to determine the amount of cases harvested, the crew harvesting the product, and the field on which the parsley was grown and harvested. The company is continuing to work with the FDA to determine a potential cause.

It is also important to note that, to date, there have been no reported illnesses associated with the consumption of these products. Moreover, although the product is over two weeks old, and likely past its useable shelf-life, the company is nevertheless working diligently with customers to ensure that the products are fully accounted for and out of the supply chain.

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The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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According to the FDA, Kellogg has announced a voluntary and precautionary recall of various waffle products produced at its Atlanta facility.

During routine sampling of a product that had not been distributed into commerce, Listeria was discovered in a product sample. In turn, Kellogg elected, in an abundance of caution, to issue a voluntary and precautionary recall of a limited number of products produced at the same facility. Click on the following link to view the FDA Recall Release.

The following waffle products are affected by the precautionary recall:

• Kellogg's® Eggo® Cinnamon Toast waffles, 10-count package, UPC code 3800040440 with Best If Used Before" dates beginning with:NOV22 10 EA, NOV23 10 EA and NOV24 10 EA.

• Kellogg's® Eggo® Toaster Swirlz™ Cinnamon Roll Minis eight-count package, UPC code 3800023370 with a "Best If Used Before" date beginning with NOV15 10 EA.

Following the discovery of the single positive sample, Kellogg also immediately and voluntarily ceased production at its Atlanta facility, began an investigation to determine a possible cause of the contamination, and also initiated a regimen of cleaning and sanitizing. According to reports, Kellogg plans to fully execute its hygienic restoration plan under GDA before it resumes any production at the facility.

It is also important to note that the recall is a precautionary measure and, to date, no reported illnesses have been associated with the consumption of any Kellogg waffle products.

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According to the FDA, Ocean Mist Farms has announced a precautionary and voluntary recall of 1,746 cases of iceless green onions. The announcement follows confirmation from federal regulators of a positive test for Salmonella on iceless green onions.

Although no Ocean Mist Farms’ product was identified, the positive sample did come from onions supplied by Circle Produce to several shippers, including Ocean Mist Farms. Thus, in an abundance of caution, the company elected to initiate a precautionary and voluntary recall. Click on the following link to view the FDA Recall Release.

The specific recalled iceless green onion pack styles and code dates are as follows:

• 4 x 12 count

• 2 x 24 count

• 24 count 5.5oz Cello Bag

• 36 count 5.5 oz Cello Bag

• 40 count 5.5 oz Cello Bag

Trace Back Code:  95ONCP7G

Production Dates: 80309; 80709; 80809; 81109; 81209; 81309

Because it is possible that a small amount of this product may have already been purchased by consumers, anyone who may have purchased onions with the trace back codes listed below should dispose of the product.

It is also important to note that, to date, there have not been any reported illnesses associated with the consumption of these products. Nevertheless, according to Ed Boutonnet, President of Ocean Mist Farms, “[t]he health and safety of our customers and their consumers always comes first. As soon as we learned of the positive test, it became our immediate responsibility to begin a voluntary recall of the product in the interest of protecting public health.”

The company also announced that it has suspended receiving any Circle Produce green onions. Instead, Ocean Mist Farms will continue to provide green onions from its own growing and packing operation.

Ultimately, Ocean Mist noted that the current inspection scheme is “having a positive effect in ensuring food safety.” In turn, following the positive sample in this case, the company was able to quickly and effectively trace back and recall all potentially affected products.

For additional information, consumers can also visit www.oceanmist.com.

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The battle for food safety continues to be waged on multiple fronts.

In addition to testing and developing new technologies (beyond cooking) to reduce naturally occurring pathogens in food, researchers are now looking for ways to defeat pathogens in our bodies.

As we reported previously, continuing NASA research might soon lead to a Salmonella vaccine. And now, we have learned, the United States military has joined the fight. According to the Washington Post, a new scientific breakthrough recently announced by the Naval Medical Research Center suggests that a Campylobacter vaccine may be on the way as well.

Campylobacter is well known as a leading cause of food-borne illness. According to some studies, the pathogen may be responsible for as many as two million cases in the United States each year, and cause several hundred million more worldwide. The infection can also (in some instances) be difficult to treat because of widespread antibiotic resistance.

Nevertheless, after a quarter century of research, Navy scientist Patricia Guerry may have discovered the path to a vaccine which will inhibit the bacteria’s ability to attach to our intestinal lining and cause illness. Indeed, as explained by the Washington Post:

Guerry, a molecular microbiologist, began her work in the 1980s and over time created new research tools that allowed her to identify the pathogen's unique genetic, biochemical and structural features. This led to the development of a vaccine that neutralizes the bacteria's ability to attach to the intestinal lining.

The vaccine candidate against the pathogen Campylobacter jejuni, developed by Guerry, her colleagues at the U.S. Naval Medical Research Center in Silver Spring and Canadian scientist Mario Monteiro, successfully protected against infection in monkeys during testing last year and is slated for human clinical trials.

If true, this may be the first known (and, promising) food-borne illness vaccine actively tested on humans. And, although Guerry has been conducting her research as part of an ongoing effort to better protect U.S. soldiers oversees, her research, of course, may very well have a profound impact on the rest of the nation – and world. Click on the following link to read the Full Story.

In any event, this is great news for industry and consumers alike. We proudly salute Guerry and, of course, the rest of her team.

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According to the FDA, Melon Acres has announced a voluntary and precautionary recall of cantaloupes because they may have the potential to be contaminated with Salmonella.

The cantaloupes affected by the voluntary recall were distributed through Farm-Wey Produce (of Lakeland, Florida) between August 13 and 14, 2009. The cantaloupes, identified as 41 MG 10, Bin Numbers 4753-4980, were shipped to Aldi's in Greenwood, Indiana and to Meijer in Lansing, Michigan, Newport, Michigan, and Tipp City, Ohio. Click on the following link to view the FDA Recall Release.

The recall was issued following routine testing by the FDA on Tuesday, August 11, 2009, which revealed that a single sample (from twenty cantaloupes taken by the Agency) tested positive for Salmonella. The FDA reported the positive test to Melon Acres on Friday, August 21, 2009.

In turn, the FDA and Melon Acres worked together to identify the field in which the positive sample was grown. According to the company, no further shipments will be made from the source field. Additionally, on August 7, 2009, Primus Labs, a third party food safety auditing firm specializing in produce, inspected Melon Acres' fields and facilities regarding its food safety practices. Melon Acres received grades of excellent/good respectively, in this audit.

It is also important to note that, to date, there have been no reported of illnesses associated with the consumption of these products. Further, the company wishes to assure the public that stringent Food Safety Programs are in place at its shipping locations and fields, and is working closely with the FDA to identify the potential source of contamination.

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Like many people, I enjoy an occasional, cold, high-quality beer. Whether it’s imported or domestic, a lager, ale, pilsner or stout, few things beat sipping from a cold mug on Sunday.

There is a one pub/restaurant in particular that I frequent, not just for their excellent selection of beer, but also for the wonderful hamburgers they serve. I’ve heard them called the best in the city. They have butter buns and are grilled in such a way that even when cooked medium well, they stay juicy and flavorful.

Well, I stopped in the other day around two p.m. Given that it was mid-afternoon, and a Sunday, the place was nearly deserted. So, I grabbed the seat near the window, which is almost always taken, and ordered a Smithwick's Irish Ale. When I looked up, I realized that I had a clear view right into the kitchen. This, I knew, could be a good or a bad thing. I loved the food here, and knowing what goes on in the kitchen could quickly ruin what has become one of my favorite destinations.

Naturally, my curiosity got the best of me. Much to my delight, I had no complaints. The cook, I soon found out, was named Ron. He kept the kitchen spotless. He washed his hands multiple times while preparing my meal . Nothing which needed to be refrigerated stayed out for more than a minute or two, and all surfaces were sanitized immediately after being used.

After finishing my hamburger, which was amazing, Ron came out of the kitchen. He was off work. I called him over and after complimenting his culinary skill I commented on how impressed I was by the cleanliness he demonstrated.

He looked at me with an almost shocked expression on his face and said,

“Well of course my kitchen is clean. How would I feel if someone got sick on my watch?” He paused and then and said, “My wife and children eat here.”

I was, naturally, very impressed. I offered to buy him a beer. He declined politely, telling me he didn’t much like beer. Well, I thought to myself, nobody’s perfect.

In any case, Ron is our newest Food Safety Hero. If you see him this weekend, or someone like him, please take a moment to say "thanks."

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According to the FDA, Quesos Mi Pueblito has announced a voluntary recall of certian cheese products because they may have the potential to be contaminated with Listeria monocytogenes. Click on the following link to view the FDA Recall Reslease.

The specific products affected by the recall, with "sell by dates" from February 2, 2009 to the present, are as follows:

• LA FE OAXACA STRING CHEESE: [USP: 0 23545 40115 6] 14 oz. pack (plastic package);

• EL VIEJITO OAXACA CHEESE: [USP: 7 18122 18071 4] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO COTIJA/AñEJO: [USP: 0 24077 10221 4] vacuum packed in plastic wrap by specific weight (plastic wrapped);

• MI PUEBLITO CUAJADA FRESCA: [USP: 0 24077 10216 0] 14 oz. pack (plastic wrapped);

• MI PUEBLITO QUESO COLOMBIANO DE ARRIERO: [USP: 0 24077 10219] 1 / 8 oz. pack (plastic package);

• MI PUEBLITO QUESO MOLIDO: [USP: 0 24077 10211 5] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO COTIJA TRIANGULO: [USP: 0 24077 10220 7] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO FRESCO: [USP: 0 24077 100258] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO QUESO FRESCO DE RANCHO: [USP: 0 24077 10215 3] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO CASERO: [USP: 0 24077 10222 1] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO OAXACA: [USP: 0 24077 10224 5] 14 oz. pack (plastic package);

• MI PUEBLITO REQUESON: [USP: 0 24077 10200 9] 15 oz. pack (plastic package); and

• MI PUEBLITO SERRANO: [USP: 0 24007 10200 0] 16 oz. pack (plastic package).

The recalled products (produced by the company in Passaic, New Jersey) were distributed through Puebla Foods, Inc. to retail stores and wholesalers in New Jersey, New York, Maryland, Delaware, and Virginia. Click on the following link to view the affected Product Labels. The potential problem was discovered through routine sampling and analyses conducted by the New Jersey Department of Health.

It is also important to note that, to date, no illnesses have been associated with the consumption of these products. Nevertheless, consumers who have purchased these products are urged to return them to the place of purchase for a full refund.

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All living creatures carry bacteria, and cattle are no exception. For this reason, naturally occurring pathogens may always remain, at least to some extent, an inherent part of the food we eat. And, according to new research, this basic tenet holds true whether beef cattle are raised conventionally, organically or even naturally.

In new study conducted by Kansas State University, researchers have found that the prevalence of E. coli O157:H7 in cattle that are organically or naturally raised is no different than the prevalence in cattle raised conventionally. The study also found that, when compared to conventionally raised beef cattle, organic and natural production had no impact on the antibiotic susceptibility of the bacteria.

As part of the recent study, researchers collected fecal samples from both organically and naturally raised beef cattle, and then tested for the presence of E. coli O157:H7. Results showed prevalence rates of 14.8% in organically raised cattle, and 14.2% in naturally raised cattle. According to the researchers, the E. coli levels were comparable to those previously identified in cattle that had been conventionally raised. Additionally, when the minimum inhibitory concentration of a variety of antibiotics for E. coli O157:H7 isolates were analyzed to determine the effects of all three production systems, no significant difference in antibiotic susceptibility was found. The findings of the study are detailed in the August 2009 issue of Applied and Environmental Microbiology.

Notably, in response to a recent increase in reported food-borne illness outbreaks, and a corresponding shift in consumer demand for organic and natural foods, many cattle farmers have considered shifting toward organic-based production methods. The new study suggests, however, that although organically and naturally raised beef may be popular for their assumed health benefits, neither have demonstrated any effect on the prevalence of naturally occurring pathogens.

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For many of us, there is nothing better than the first bite of a delicious steak. Whether it is a sirloin, tenderloin, or perhaps grill-fired New York Strips shared with family and friends, there is a lot to be said for a good cut of beef.

This also, however, raises an important question. Beyond tasting delicious, to what extent is meat really an integral part of a healthy diet?

Many Vegetarians assert that among other things, living as a Vegetarian improves health. An Australian-Vietnamese study published in the July 2 edition of the American Journal of Clinical Nutrition, however, disputes this concept. The research has shown that Vegetarians can have as much as a 5 percent lower bone density than individuals who consume meat. Vegans are potentially worse off, at 6 percent.

The Mayo-Clinic states that a vegetarian lifestyle can lead to a number of necessary vitamin deficiencies. They include:

• Protein. Your body needs protein to maintain healthy skin, bones, muscles and organs. Vegetarians who eat eggs or dairy products have convenient sources of protein. Other sources of protein include soy products, meat substitutes, legumes, lentils, nuts, seeds and whole grains.

• Calcium. This mineral helps build and maintain strong teeth and bones. Low-fat dairy foods and dark green vegetables, such as spinach, turnip and collard greens, kale, and broccoli, are good sources of calcium. Tofu enriched with calcium and fortified soy milk and fruit juices are other options.

• Vitamin B-12. Your body needs vitamin B-12 to produce red blood cells and prevent anemia. This vitamin is found almost exclusively in animal products, including milk, eggs and cheese. Vegans can get vitamin B-12 from some enriched cereals, fortified soy products or by taking a supplement that contains this vitamin.

• Iron. Like vitamin B-12, iron is a crucial component of red blood cells. Dried beans and peas, lentils, enriched cereals, whole-grain products, dark leafy green vegetables, and dried fruit are good sources of iron. To help your body absorb nonanimal sources of iron, eat foods rich in vitamin C — such as strawberries, citrus fruits, tomatoes, cabbage and broccoli — at the same time you consume iron-containing foods.

• Zinc. This mineral is an essential component of many enzymes and plays a role in cell division and in the formation of proteins. Good sources of zinc include whole grains, soy products, nuts and wheat germ.

Although most of these vitamins can be replenished by taking supplements and eating things like tofu-dogs, cod liver oil and soy burgers, it does seem like a lot of work.

So, as delicious as a lentil wrapped wheat germ biscuit may be, rest assured that a delicious, perfectly cooked steak with some garlic butter, red potatoes and a glass of cold milk will, indeed, do wonders for your health.

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According to the FDA, SUPERVALU has announced a voluntarily recall of frozen Culinary Circle Gourmet Macaroni and Cheese products because they may have the potential to be contaminated with listeria monocytogenes.

The products affected by the recall include Culinary Circle Gourmet Macaroni and Cheese (a frozen product) sold in 38 oz. packages with a UPC# of 41130 38704. The products were sold at numerous SUPERVALU-owned stores including Acme, Albertsons, biggs, Cub Foods, Farm Fresh, Hornbacher’s, Jewel-Osco, Lucky, Shaw’s/Star Market, Shop ‘n Save, and Shoppers Food & Pharmacy. Click on the link to view the FDA Recall Release.

It is important to note that there have been no reported illnesses associated with the consumption of these products. Rather, the possibility for contamination was identified through routine microbiological sampling at the manufacturing facility.

In turn, because the safety of its customers is a top priority of the company, SUPERVALUE has elected, in an abundance of caution, to issue a precautionary and voluntary recall of these products.  Health officials also remind consumers that thoroughly cooking all raw foods will typically destroy any pathogens that may be present, and render such products safe

Customers who have purchased the affected product can bring it back to their SUPERVALU-owned store for a full refund or exchange.

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Salmonella has dominated the news as of late. Once an illness thought to come only from runny eggs and raw chicken, it has now been found in a wide variety of foods including peanuts, dried gelatin, and, bizarrely, frog legs. The recent PCA Salmonella outbreak was perhaps the largest in history.

Salmonella has been around for a long time, causing illness in humans for at least one hundred years. Now, science may be on the verge of finding a vaccine. The fight for a vaccine is taking place in labs across our world – as well as in others beyond it.

Astronauts have been conducting Salmonella experiments aboard the International Space Station with results that have been both surprising and promising. Previous studies have shown that weightlessness can have a dangerous affect on bacteria and pathogens. Early data indicated that Salmonella became much more virulent in a zero gravity environment. The studies were conducted as a corollary to the well documented loss of immunity in micro-gravitational environments and the fear that astronauts might be more susceptible to food-borne illness.

Further research, however, has led to the discovery that Salmonella’s virulence can not only be controlled, it can actually be turned off. The discovery sent shockwaves through the scientific community and carries with it incredible ramifications.

If the infectious part of Salmonella can be negated, then it is possible for the pathogen to be introduced to our bodies without causing illness. This, potentially, would allow our immune system to develop immunity without ever having to experience the symptoms.

Here on Earth, at the Institute of Food Research in Norwich, UK, researchers are also close to finding a vaccine. They have shown, after a number of breakthroughs that Salmonella relies on glucose for its own survival during the infection stage. While seemingly trivial, the discovery allows for the possibility of a vaccine not just against Salmonella and other food-borne pathogens, but also a range of other superbugs.

“This is the first time that anyone has identified the nutrients that sustain Salmonella while it is infecting a host’s body,” said Dr. Arthur Thompson, IFR group leader. “Our experiments showed that glucose is the major sugar used by Salmonella during infection,” said Dr Thompson.

Scientists believe they can turn off the cells ability to absorb glucose which would render them incapable of replicating. The salmonella would, however, continue to stimulate an immune response which would eventually lead to immunity.

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According to FSIS, Sterling Pacific Meat Co. has announced a voluntary recall of approximately 3,516 pounds of ground beef products that may be contaminated with E. coli O157:H7.

The ground beef products affected by the voluntary recall were produced by the company (located in California) on May 18, 2009, and were distributed at the wholesale level to food service companies, who further distributed the product to restaurants in California and Arizona. FSIS has no reason to believe that the products are available for sale in commerce. Click on the following link to view the FSIS Recall Release.

The specific products subject to recall include:

Fatburger Brand:

• 20-pound packages of "8 oz. PUCK (80/20) GROUND BEEF PATTIES."

• 10-pound "2.5 oz. BABY GROUND BEEF PATTIES."

Cattleman's Choice Brand:

• 12-pound packages of "6 oz ROUND 80 % LEAN PURE GROUND BEEF PATTIES." Each package bears the identifying case code "13627."

• 12-pound packages of "(3/1) ROUND 80% LEAN PURE GROUND BEEF PATTY." Each package bears the identifying case code "13582."

• 12-pound packages of "(3/1) ROUND 80% LEAN GROUND BEEF PATTIES." Each package bears the identifying case code "10457" and the pack date "05/18/2009."

• 12-pound packages of "GROUND BEEF PATTY (8/1) SLIDER 80% LEAN." Each package bears the identifying case code "13657" and the pack date "05/18/2009."

• 12-pound packages of "(4/1) ROUND 85% LEAN PURE GROUND BEEF PATTY." Each package bears the identifying case code "13575" and the pack date "05/18/2009."

• 12-pound packages of "PURE GROUND BEEF PATTY 7oz WIDE PATTY 80% LEAN." Each package bears the identifying case code "13520" and the pack date "05/18/2009."

• 12-pound packages of "PURE GROUND BEEF PATTY (7/1) ROUND PATTY 80% LEAN." Each package bears the identifying case code "13577" and the pack date "05/18/2009."

• 11.80-pound packages of "PURE GROUND BEEF PATTIES 7 oz ROUND 80% LEAN." Each package bears the identifying case code "13520" or "13561" and the pack date "05/18/2009."

The packages also bear the establishment number "EST. 550" within the USDA Mark of Inspection and advise "KEEP REFRIGERATED" and/or "KEEP FROZEN."

The problem was discovered by FSIS during a review of the establishment's records. To date, there have been no reported illnesses associated with the consumption of these products. FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

AUGUST 15, 2009 UPDATE:

Please note that the FSIS Recall Release was on updated Aug 15, 2009 to correct a product description in the original release. The updated release makes it clear that one of the recalled brands is "Cattleman's Choice," not "Stock Yards Brand." "Stock Yards Brand" products are not subject to this recall. Please note that product labels subject to recall are similar, but recalled products would read "Cattleman's Choice" instead of "Stock Yards Brand."

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NewStar Fresh Foods (based in California) has announced a precautionary recall of 772 cartons of iced jumbo green onions (under the brand names Omo and Fu Choy) which could potentially be contaminated with Salmonella.

According to the FDA, The onions were distributed from three locations, R.A.M. Produce Distributors of Detroit, Michigan, Franzella Distributing of San Francisco, California, and United Food Service of East Point, Georgia. Click on the following link to view the FDA Recall Release.

The product was packaged in a 48-count iced carton, with item numbers 02487403 and 02487452, product lot numbers 40550707 and 40510707, and production dates of July 20th and July 21st 2009. No other food service distributors or products are involved in this recall. Notably, all affected product within the foodservice channel has already been accounted for and destroyed.

58 cartons were shipped from two distributors to small grocery outlets in the Detroit and San Francisco areas. Consumers in California may have purchased the product from Larry’s Produce in Fairfield, La Loma Produce, Good Life Grocery and El Grande, all San Francisco, and Valley Produce & Meat Market, San Pablo. Consumers in Michigan may have purchased the product from Confers Supermarket in New Lothrop, Ryan’s Food in Detroit, Brothers Supermarket and Al Jazeera Market in Dearborn and Sahara Market in Warren.

Although it is likely that the jumbo green onions are now beyond their usable life, the voluntary recall is being issued by the company out of an abundance of caution for consumer well-being in the possible event some consumers might have purchased from the listed retail outlets and still have the product in their home refrigerators.

The company is working closely with regulatory authorities at the state and federal levels to inform consumers in Detroit and San Francisco areas who may have purchased the product. To date, there have been no illnesses associated with the consumption of this product.

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Adams Extract and Spice has announced a voluntary recall of various spice products following the discovery of Salmonella during routine product testing.

The spice products being recalled were processed using a specific lot of ground red pepper supplied by Van de Vries Spice Corporation (located in New Jersey). Although the lot of ground red pepper initially tested negative for Salmonella, a second sample drawn from the same lot reportedly confirmed positive for the pathogen.

The products affected by the voluntary recall were distributed in Texas, Louisiana, and New Mexico through retail stores, mail order, internet sales and direct delivery.

Click on the following link to view a copy of the FDA Recall Release. The specific products subject to the recall include:

Items in clear plastic (PET) bottles with yellow caps:

• Adams Cayenne Pepper 2.61 oz Best by date 060311-060711, 062711-070111, 071811-072211, 080111-080511;

• Adams Brisket Rub 13.47 oz Best by date 062111-062511, 062711-070711;

• Adams Brisket Rub 8.5lbs Best by date 062811-070211;

• Adams Multi-Season Seasoned Salt 14.46 oz. Best by date 070511-070911;

• Adams Multi-Seasoning 30 oz. Best by date 071111-071511;

• REX Cayenne Pepper Ground 6.98 oz. Best by Date 072111-072511, 071111-071511; and

• REX Cayenne Pepper 16 oz. Best by Date 071111-071511.

Items in french square glass bottles with silver-tone caps:

• Adams Reserve Cajun Seasoning 4.93oz. Best by date 061011-061711, 071311-071711.

Items in translucent polypropylene jars with translucent caps:

• Carniceria Texas Red All Purpose Seasoning Adams 14.25oz. Best by date 061711-062111; and

• Carniceria B-B-Q Seasoning Adams 15.07oz. Best by date 061611-062011.

Items in red trimmed "cello" packages:

• REX Crab Boil Ready Mix 64 oz.

Items in green trimmed "cello" packages:

• REX Fish Fry 10 oz.

To date, there have been no reported illnesses associated with the use of these products. Consumers who have purchased these products, however, are being urged by the company to return them to the place of purchase.

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BY Guest Blogger James Marsden

About a year after the 1993 Jack-in-the-Box E. coli O157:H7 outbreak, I moved from the AMI Foundation in Washington, DC to KSU in Manhattan, Kansas to join their beef safety research group. Some of the first people I met in Kansas were Lee Borck, Kenny Knight and Andrew Murphy, three beef producers and co-founders of The Beef Marketing Group (BMG), www.beefmarketinggroup.com.

We had discussions then about pre-harvest food safety and its importance in an integrated food safety system for control of E. coli O157:H7. At a time when very little was being done in this segment, BMG initiated a comprehensive program called “Progressive Beef” that included HACCP at beef feedlots, quality systems, domestic source verification and a plan to address animal handling and welfare. They also implemented a Natural Beef program in which hormones and antibiotics are never administered, no animal byproducts are used in feed and cattle are sourced and age verified from birth.

Recently, I visited one the BMG feedlots near Great Bend, KS and reviewed the food safety and animal welfare programs that had been put in place over the past several years. HACCP is strictly voluntary for beef producers, but BMG’s HACCP system is as well designed and comprehensive as if were a regulatory requirement. There are also extensive animal handling systems and training for BMG employees and drivers who transport cattle. The animal identification and traceability systems are amongst the best in the industry.

All of this was impressive, but what I found to be most notable, was that all of the work and capital that were required to achieve these remarkable results happened because of BMG’s vision and commitment to food safety, sustainability and animal welfare. None of it was required by federal regulations.

At the time BMG made these commitments, considerable investments were required and there was no assurance that they would ever be recovered. As it turned out, there are plenty of customers who like the safety and quality elements of the BMG systems, including Natural Beef and are willing to pay a premium to get them.

For years, the beef industry has had to operate in a world in which the retail value of beef products didn’t allow for profitability between all sectors. The BMG systems add value to beef and that added value supports profitability for beef producers, packers and retailers.

The founders of the Beef Marketing Group decided to produce products that meet consumer expectations. The result is one of the most successful beef production companies in the world.

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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.

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Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius have announced that “prevention and partnership” will guide their departments' efforts to safeguard our food supply. These announcements are based on the public health principles embraced by the White House Food Safety Working Group led by Sebelius and Vilsack.

According to Vilsack, "making prevention a priority is critical to reducing food-borne illness and one of the three food safety principles of President Obama's Food Safety Working Group.” In turn, Vilsack and Sebelius announced the following new initiatives designed to accomplish these goals.

Beef Safety - E. Coli Testing Of Bench Trimmings

For starters, the USDA's Food Safety Inspection Service (FSIS) is issuing guidance for inspectors to begin conducting routine sampling of bench trim for E. coli. In the past, the FSIS had not routinely tested bench trim. Rather, FSIS started E. coli O157:H7 testing with ground beef, and expanded testing to other beef components used in ground beef. Bench trim, which will now be tested as well, includes pieces left over from steaks and other cuts that are then used to make ground beef. FSIS is also issuing streamlined, consolidated instructions to its personnel for inspection, sampling and other actions to help reduce E. coli O157:H7 in beef. Click on the following link to view a copy of the FSIS Sampling Notice.

Produce Safety – New Draft Guidance

Secretary Sebelius also praised new draft guidances prepared by the FDA, an agency within HHS, aimed at minimizing contamination in leafy greens, tomatoes, and melons. According to Sebelius, "the proposed controls provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated." The draft guidances also represent a shift in strategy for the FDA, from a food safety system that often has been reactive to one that is based on preventing food-borne hazards. Click on the following link for information on the Draft FDA Guidances.

Although the new controls are aimed at preventing contamination in the first instance, Secretary Sebelius also confirmed that consumers play a vital role in ensuring the safety of the fresh produce they eat. In turn, she offered the following tips from the CDC:

• Buy wisely. Don't buy produce that is bruised or damaged. When buying fresh cut produce, choose only items that are refrigerated or surrounded by ice.

• Refrigerate promptly. Certain perishable fresh fruits and vegetables (e.g., strawberries, lettuce, herbs, and mushrooms) should be stored in a clean refrigerator at a temperature of 40ºF or below. If you aren't sure whether an item should be refrigerated, ask your grocer. Produce that is purchased pre-cut or peeled should be refrigerated within two hours.

• Prepare produce with clean hands. Wash hands for 20 seconds with warm water and soap before and after preparing fresh produce.

• Wash produce thoroughly. Rinse fruits and vegetables under running water. Scrub firm produce such as melons and cucumbers with a clean produce brush. All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly rinsed before eating. This includes produce grown conventionally or organically at home, or produce from a grocery store or farmer's market.

• Do not cross contaminate. Don't give bacteria the opportunity to spread from one food to another. Consider using one cutting board only for foods that will be cooked such as raw meat, and another one for ready-to-eat foods such as raw fruits and vegetables.

According to FDA Commissioner Margaret A. Hamburg, the new draft guidances embody the Administration’s and FDA’s prevention-oriented food safety strategy.” She also confirmed that, while the proposals are still in draft form, “they will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

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After failing to pass a  vote in the House of Representatives on Wednesday (July 29), the Food Safety Enhancement Act of 2009 (H.R. 2749) returned to the House floor for a second vote on Thursday (July 30).  

On the second try, the Dingell-Waxman bill, designed to modernize the FDA’s food safety authority, passed by a vote of 283 - 142. Click on the following link for a summary of the legislation.

Key provisions of the bill include the following:

• Inspections: Food and Drug Administration inspections of food facilities would increase from about once every 10 years to at least annually for high-risk facilities and at least once every three years for facilities deemed a low risk. FDA inspectors will have access to company records.

• Registration: Food processors, importers and other food handlers must register annually with the FDA and pay a yearly fee of $500 for each food facility.

• Recalls: The FDA could mandate the recall of tainted foods, instead of relying on food makers to pull items voluntarily.

• Safe practices: For the first time, the FDA could set standards for safe production of food on farms, as well as require food manufacturers to meet safety standards.

The 132-page bill now goes to the Senate where Illinois Democrat Dick Durham is waiting with his own bill.   Any differences between the House and Senate versions will likely be resolved by Conference Committee. Reportedly, President Obama already endorsed the House bill before Thursday’s successful vote.

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According to FSIS, King Soopers has announced a voluntary recall of various ground beef products after learning the products could potentially be linked to an ongoing Salmonella outbreak. The possible association is being investigated by the Colorado Department of Health.

Approximately 466,236 pounds of ground beef chubs, tray packs and patties (processed in Denver, Colorado) are affected by the voluntary and precautionary recall. The products were processed on various dates between May 23, 2009 and June 13, 2009, and bear Establishment Number "EST. 6250." In turn, the ground beef chub products bear a use-by/sell-by date between "05/31/09" and "06/21/09;" the tray packs of ground beef bear a use-by/sell-by date between "06.02.09" and "06.23.09;" and the ground beef patty products bear a use-by/sell-by date between "06.01.09" and "06.22.09." The products were distributed to retail establishments in Colorado, Kansas, Missouri, Nebraska, New Mexico, Utah and Wyoming. The products (produced in Denver, Colorado). Click on the following link to view the FSIS Recall Release.

The specific products subject to recall include:

• 1-pound chubs of (93/7) ground beef. Each package bears the identifying case code "69558."

• 1 - 1.25-lb. tray packs of (96/4) ground beef. Each package bears the identifying case code "67164."

• 1 - 1.25-lb. tray packs of (96/4) ground beef. Each package bears the identifying case code "67664."

• 1 - 1.25-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67663."

• 1 - 1.25-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67163."

• 2.5 - 3-lb. tray packs of (93/7) ground beef. Each package bears the identifying case code "67654."

• 6-pack trays of (93/7) ground beef patties. Each package bears the identifying case code "67106."

• 4-pack trays of (93/7) ground beef patties. Each package bears the identifying case code "67115."

As a result of an ongoing investigation into an outbreak of Salmonella Typhimurium DT104 potentially associated with ground beef, the Colorado Department of Public Health notified FSIS of the problem. Epidemiological investigations, and a case control study, conducted by Colorado Department of Health and CDC determined that there may be an association between the fresh ground beef products and 14 illnesses reported in Colorado.

Although the FSIS has no reason to believe that the products are still available for sale in commerce, the agency is nevertheless advising consumers that may have purchased the fresh ground beef between May 23 and June 23, 2009, and who may still have the products in their freezers, to look for and discard any potentially affected products.

As always, FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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