The Three "Cs" of Food Safety

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The greatest challenge for the food industry over the past decade has been to continuously find new and better ways to make our food supply safer. Some companies focused on improving their sanitation programs, some companies focused on improving their HACCP plans, and some companies focused on investing in new interventions. Some companies focused on all of these.

Far fewer companies focused on what matters most – people. I have always said that any good platoon will only be as fact as its slowest runner. Thus, in order to truly succeed when it comes to food safety, we have to find ways to make our employees better.

The place to start is by embracing the three “C’s” of Food Safety:” Compassion, Commitment and Culture. Each of these attributes is, by definition, going to be highly important in anything we do. But, when it comes to food safety, all three are critical.

Food safety will never exist in any organization if there is no compassion. The only reason people will be motivated to make food safety a priority is if they are compassionate about not making people sick. To be effective, this type of compassion must be the same type and level of compassion you reserve for your family. For the middle-management and line-employees to show this level of compassion in their daily jobs, it must first be embraced and communicated by the corporate leadership. Put simply, you need to show more compassion.

The corporate leadership must also demonstrate a commitment to food safety. It is one thing to say you are compassionate about not making people sick, but you must also invest in the actual programs, training and interventions that are required to make it happen. To succeed, corporate leadership must fully support the efforts of the management and employees who are trying to embrace it as well. In addition to supporting new food safety-oriented initiatives and technologies, you should also recognize and reward employees weekly for excellence in food safety. Such programs will enhance the visibility and prominence of food safety in the company, and also get employees talking about it.

If a company’s corporate leadership shows compassion for food safety and commits to support it, a robust food safety culture will eventually develop. With continued support, this culture will flow from the top, and eventually permeate every aspect of the operation. And, once it takes hold, it will become part of the organizational “speak” and continue to grow. I have seen this happen on many occasions.

We are moving into a world where food safety matters, where food safety is maturing and where ,for the first time ever, food safety is marketable. By embracing the three “Cs” of food safety, compassion, commitment and culture, you stand apart from your competitors and closer to your customers.

A Century of Food Safety Gives Us A Glimpse Into The Future

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Over the past Century, the ways in which our food has been grown, manufactured, distributed and regulated have changed dramatically.  There have been countless changes in food science and technology and the consumer preferences that drive them.  Food safety awareness has now been elevated to its highest level during the history of our nation.  And, as we begin to ask ourselves what the next 100 years will bring, we would be well served to allow the last 100 years serve as our guide.

Where has the meat industry been?

A little over 100 years ago, with advances in technology, the food industry began better understand how to make food more accessible on a much larger scale.  With improved preservation techniques and the emergence of rapid transnational shipping, food processors could for the first time in our nation’s history produce and viably ship perishable products anywhere in the country.

At that time, however, the food industry was primarily regulated at the local level.  In particular, the laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state.   As can be expected within a growing nation, however, industrial advances began to outpace the inherent limits of these local and non-uniform regulations. 

In many cases, what was forbidden in one state was entirely lawful in another.  Without a federal approach to food safety (and a single set of rules), there was no way to provide consumers with any confidence in the origins or safety of their food.

Advances outside of the food industry inspired substantial change as well.  With the creation of newspapers that for the first time reached across the country, individuals and consumer groups had the opportunity to voice their concerns.  Social reformers, who otherwise would have remained unheard, were also able for the first time to reach a broad audience.  The most famous example of these was Upton Sinclair, a man whose work ultimately led to the creation of the complex laws under which we operate today.  Indeed, in his 1906 novel, The Jungle, Sinclair described in gruesome the unsanitary conditions prevalent in large meat slaughter plants.  The book described unwholesome carcasses being processed for use in food, processing taking place in unhealthy conditions, and meat and other food products coming into contact with contaminants present in the plants.

These conditions outraged the public, and the United States Congress quickly realized that a uniform food safety policy (i.e., a single set of rules) was essential to protect the health of the nation.  In 1906, Congress passed the Wholesome Meat Acts.  This law for the first time mandated that federal inspectors be assigned to and present in beef slaughter and processing establishments, and continues to form the framework for the national food safety laws that continue to exist to this day.

Where is the meat industry today?

As any involved in the industry knows, beef regulation has moved from the old organoleptic-based inspection system embraced in 1906 (sight, smell and touch) to a food safety system which relies heavily on science and microbiology. In the 1990s, the United States Department of Agriculture (USDA) began requiring that all meat and poultry processors adopt Hazard Analysis and Critical Control Point (“HACCP”) plans.  Although this represented a revolutionary change in the way food was regulated, it industry was able to successfully implement HACCP in thousands of plants in only a few years.

In the years since it was implemented, there can be little doubt that HACCP has been incredibly effective in improving the safety of our food supply.  Indeed, in the last few years, there has been a drastic downward trend in the number and scope of recalls involving the presence of pathogens.  Moreover, in 2011, recognizing the success of HACCP in the meat industry, Congress passed the Food Safety Modernization Act (“FSMA”).  The Act will eventually require all FDA-regulated food companies to adopt and follow written food safety plans using the HACCP methodology.

Food product testing has advanced considerably in recent years.  Food companies now understand that if their food products are contaminated with pathogens when they leave the company’s control, there is in increased likelihood that those contaminants will be found. Indeed, more and more food processors are now sampling incoming raw materials and finished products before using or selling them. Additionally, companies also recognize that if any existing contamination is not detected through product testing, there is a good chance that it will be found (if someone gets sick) by the Centers for Disease Control (CDC).  Indeed, foodborne illness and outbreak surveillance has become so robust in recent years that if a food causes a foodborne illness or cluster, CDC and USDA investigators will in most cases be able to trace the offending product back to the company from which it originated.

In recent years, the media has also played a substantial role in increasing the overall quality and safety of our food. With more companies testing for pathogens, more pathogens are being found and more products are being recalled.  In turn, through its reporting on outbreaks and recalls, the media has played a significant role in raising the overall awareness of food safety among U.S. consumers.  In turn, U.S. consumers are now paying far more attention now to the origin, quality and safety of the food products they buy and eat.  These trends will continue.

Where will the industry be tomorrow?

If the past 100 years provides any glimpse into what the future holds for the food industry, the industry will likely be confronted with even greater change.   Reserving my own judgment, I firmly believe that we are moving as a nation toward a day when pathogens in all food products are fully controlled – as a matter of course.  Consumer expectations have changed drastically over the last 100 years, and those expectations will continue to evolve.  As consumers continue to read about large-scale food product recalls on the internet, and continue to watch stories about the human consequences of outbreaks on the news, Congress and USDA will continue to be pressed by consumers and the media to respond.  

This pressure from consumers and the media will not decrease in the future and will continue to shape food safety policy.   Whether we agree with it or not, we will reach a day in the future when consumers will no longer allow industry to sell raw animal products that carry a risk of making them sick.   As interventions continue to advance, industry will respond by finding new ways to ensure that raw animal (and other) products are pathogen free.   Although this change cannot and will not happen overnight, I do believe that this change will come.

In the meantime, continue to do an outstanding job safely feeding a nation.  Your work is important, and your contributions should be recognized.  Take exceptional pride in what this amazing industry has accomplished over the decades, and know this -- just like it did during the last 100 years, the beef industry will continue to lead the way.   Here too, history continues to be our guide.  The West wasn’t won on salads, after all.  The West was won on beef.

Listeria Continues To Pose Problems For Processors

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Whether we like it or not, recalls will continue to happen. And, they will continue to occur for a wide variety of reasons.

Although recalls for E. coli O157:H7 are on the decline, recalls for allergens are spiking. And, many recalls happen for other reasons as well. Each time a recall is announced, the meat industry faces significant exposure for any personal injury or commercial claims which result.

Indeed, in 2009, industry voluntarily initiated a total of 69 recalls of meat products for the presence of pathogens, undeclared allergens, foreign materials, and for processing and other defects. In 2010 and 2011, the number of recalls increased respectively to 70 and 103. In 2012, the total number dropped to 82, and so far this year, there have been 66. Industry is on course to end the year with about 75. During these five years, there have been a total of 390 recalls of meat products (totaling more than 300,000,000 meals), with significant corresponding liability and brand-damage exposure.

While many recalls result from processing errors which are easy to identify and fix, some causes are more difficult to control. One silent culprit is Listeria monocytogenes (“Listeria”). Each year in the United States, Listeria causes an estimated 1,600 illnesses and 260 deaths. The largest Listeria outbreak occurred in 2011, when contaminated cantaloupe sickened 1476 and killed 33. The owners of the company were charged criminally for failing to adequately control for Listeria

And, Listeria poses significant challenges for the meat industry as well. Over the least five years, nearly 15 percent of all meat industry recalls have been caused by the presence of Listeria in ready-to-eat (RTE) products. In 2009, industry announced a total of 8 recalls relating to the presence of Listeria in 50,000 pounds of RTE products. In 2010, an additional 400,000 pounds were recalled for the presence of Listeria. In both 2011 and 2010, over 500,000 pounds of meat was recalled and, so far in 2013, there have been almost a dozen recalls involving nearly 1,000,000 pounds of RTE meat.

Listeria is very good at evading detection.

Once Listeria finds harborage in the processing environment, it can be very difficult to find and eliminate. For this reason, FSIS requires establishments that produce post-lethality RTE products to develop and follow Listeria control programs. Nevertheless, every establishment should constantly challenge itself to reassess its programs and find new and better ways to shield its operations from this evasive pathogen.

In addition to adopting robust written sanitation and sampling programs, companies should also embrace emerging and affordable technologies like advanced oxidation and ionization to treat the broader environment. These airborne technologies, which I have seen employed effectively, can actively reach and significantly reduce microorganisms in ways and in places where water and sanitizers can’t.

The fact is, Listeria remains perpetually difficult to control. But, by embracing the right food safety culture, developing a strong science-based control program, and implementing new and emerging solutions, these overlapping efforts can have a significant effect on reducing the risk of Listeria substantially.

FDA Proposes Competing Foreign Supplier Verification Rules

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Often, the things we fear most are the things we cannot see.  In the food industry, the fear of the unknown in recent years has driven substantial change. Here in the United States, industry has responded to the threat of invisible microorganisms, quite literally, by “turning on the lights.” In particular, more and more food companies are testing more ingredients, more equipment and more finished products, and more and more harmful pathogens are being found.

Similar concerns exist with respect to the overall safety of foreign food product imports. Indeed, if we stand on the beaches of California, we cannot see what is happening on the opposite shore. The inability to see clearly (or, at all) what is occurring with respect to the growing, processing and export of incoming foreign foods causes both industry and the government to become increasingly fearful of the unknown.

And, there are political reasons as well. More than 15 percent of the food consumed in the United States each year is imported from foreign shores. And, this number is growing larger. Increasingly, more and more consumers are beginning to question where their food is coming from, and what is being done by government and industry to ensure its safety. This is especially true when foreign food products have been involved in an increasing number of food safety scandals. Headlines have included stories about melamine in pet food, mercury in baby formula, and the misbranding of meat (i.e, marketing rodent muscle as lamb).

So, what is the solution? Here too, rather than urging companies to stop buying foods from foreign countries, FDA has proposed instead to “turn on a few more lights.” Moving forward, FDA will require all food companies in the United States who import foreign food products to take steps designed to ensure that the food they are importing is as safe as it can be.

Well, maybe. You see, no one expected that, when the FDA published its proposed Foreign Supplier Verification Program rules, FDA would actually publish two sets of rules – and invite key stake holders to, in effect, “vote” on which of the two they liked best.

On the one hand, the FDA’s approach might be viewed as be commendable for letting consumers, industry and politics guide the debate; but, on the other hand, the agency appears to be sidestepping its responsibility of issuing regulations which, in its expert judgment, are best suited to keep industry strong and consumers safe. With that said, whether motivated by a fear of being perceived by suppliers, industry and consumers as doing “too little” or being perceived as doing “too much,” FDA seems to be hedging its bets by proposing two alternatives.

For simplicity sake, let’s call the two sets of proposed rules “Option 1” and “Option 2.” In its most simple form, Option 1 creates stringent auditing requirements on higher-risk foods, and less stringent requirements on low-risk foods. Option 2 simply creates less stringent requirements on all foods, regardless of risk.

Although I will address both the potentially catastrophic and life-saving effects of the proposed rules in a moment, it’s important to first understand how the rules really are different.

Under Option 1, if a food product is subject to a hazard that is reasonably likely to occur, and there is a reasonable probability that exposure to the hazard will cause serious adverse health consequences or death, then the importer must ensure that the foreign supplier is being audited at least once annually by a qualified individual. A qualified individual is a person with the necessary education, training and experience to conduct a food safety audit which will ensure that the foreign supplier is complying with the regulations.

If, however, a food product under Option 1 is subject to a hazard for which there is not a reasonable probability that exposure will cause adverse health consequences or death, the requirements are far less stringent. In these circumstances, the importer will have the ability to choose for itself which verification procedure from a list proposed by FDA it will use. These less-stringent verification procedures include: (1) periodic onsite auditing; (2) periodic lot-by-lot sampling and testing of the food; (3) periodic review of the foreign supplier’s food safety records; and (4) any other procedures which, in the discretion of the importer, are deemed “appropriate.”

Under Option 2, regardless of the level of risk associated with a food product, an importer will be able to establish compliance by merely selecting one of the less stringent verification procedures outlined above. Thus, the real difference between Option 1 and Option 2 is that, with respect to food products that carry a reasonable likelihood of causing adverse health consequences or death, under Option 2 there is no auditing requirement. Instead, importers simply could choose to periodically review the supplier’s food safety records, to periodically test the supplier’s products, or to follow any other verification procedures the importer deems “appropriate.”

So, in light of the differences between the two options, how could choosing one or the other really be a matter of life or death? Well, the answer really depends upon whether the question is viewed through the lenses of foreign product suppliers, importers or consumers.

From the perspective of foreign food product suppliers, Option 2 may be interpreted as the only real option. Under Option 2, importers could demonstrate compliance, regardless of the capabilities or qualifications of the foreign supplier, by simply “periodically” testing incoming products or selecting one of the other less-stringent procedures (or, I guess, by simply making up one of its own). If Option 1 were selected, however, a large number of existing foreign food product suppliers would likely be forced out of business.

This is because many foreign suppliers, in order to export to the United States, would be forced pass a physical audit requiring them to demonstrate actual compliance with each of the requirements of the FDA’s Food Safety Modernization Act (“FSMA”), including the requirement that they develop and implement a science-based written preventative control program. Foreign suppliers would also be required, in order to pass that audit, to comply in other respects as well, demonstrating that they have adequate prerequisite programs, equipment and facilities. Because many foreign suppliers would be unable to satisfy the proposed auditing requirements, they would also be unable to export foods to the U.S. Thus, from the perspective of many foreign food product suppliers, the choices being proposed by FDA raise literal questions of life and death.

From the standpoint of the importer, the answer is less clear. On the one hand, the audit requirements should be welcome from the standpoint of sophisticated companies. Requiring audits of all foreign suppliers of high risk foods will enhance incentives for foreign suppliers to upgrade their food safety systems, will ensure the increased safety of all high-risk foods, will promote the application of uniform standards applicable to all foreign suppliers, and will level the competitive playing field for all importers. On the other hand, the cost of foreign food product imports will likely increase (at least in the short-term) as companies work to achieve compliance, and importers will likely be burdened with increased regulatory costs as they themselves work to ensure that their foreign suppliers are FSMA compliant and being properly audited by qualified individuals. So, bottom line is that everyone wins, but foreign imports become a bit more costly.

From the standpoint of consumers, Option 1 is without question the only option. As noted above, we often fear (sometimes for good reason) what we cannot see. Option 1, for all practical purposes, is the only option that actually “turns on the lights” with respect to foreign food products. If enacted, each foreign supplier of high risk foods will be required to have an audit. In order to pass that audit, the foreign food product supplier will be required to establish that it satisfies, with only a few exceptions, each of the more stringent requirements of FSMA. Unless this option is selected for enforcement by FDA, importers will be able to select any one of the less-stringent verification procedures requiring only “periodic” checks of records or testing, and many foreign food product suppliers who remain unable to pass a simple audit will continue to exist unregulated and unsupervised in the shadows. From the standpoint of the unwary consumer, choosing the wrong path could have catastrophic consequences.

So, if you join me in the basement, so we can escape even for just a moment the politics of global food safety and foreign trade (which, in this business, is nearly impossible to do), I offer the following advice: if the real goal is to improve the safety of foreign food product imports, then Option 1 is the only best choice. Option 1 will quickly and brightly illuminate non-compliant suppliers, will improve the quality and safety of all imported foods and, in doing so, will save lives.

FDA has given stakeholders until January 27, 2014 to comment on the two competing rules. I urge you to comment on the option you like best, but warn that the choice you make could have a substantial and direct impact on the future safety and quality of imported foods.

Allergens Begin To Outpace Pathogens As Primary Driver Of Recalls

In life, there is rarely a moment when we don’t face some type of challenge. And, typically, just as one challenge is overcome, another will almost invariably take its place.

The same principle holds true in the meat industry. Just as we are now witnessing a substantial decrease in the number of recalls being driven by harmful pathogens, like E. coli O157:H7, we have also witnessed a tremendous upswing in the number of recalls driven by undeclared allergens.

Indeed, in the last two years, there have only been a handful of recalls announced as a result of E. coli O157:H7. At the same time, the meat industry announced nearly 50 recalls -- involving over a million pounds of product -- for the presence of allergens. So, here too, as one challenge (E. coli O157:H7) is nearly defeated, another challenge (undeclared allergens) steps in to take its place.

Over the last decade, the food industry developed a better understanding of the effect of allergens in the food supply and on consumers. In response, Congress enacted new laws aimed at ensuring that allergens in food products are properly labeled and disclosed. Specifically, the Food Allergen Labeling and Consumer Protection Act (FALCPA), passed in 2004, requires manufacturers of all FDA regulated food products to disclose the presence of eight known allergens. These allergens, which cause the vast majority food allergies, include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.

In meat establishments, FALCPA does not apply. Rather, FSIS regulates the ingredients in meat products by pre-approving all product formulations and labels (which, by definition, would include the identification of any allergen-containing ingredients that might be contained within a product). In turn, to more aggressively enforce allergen control in federal establishments, FSIS is now focused on making sure that an establishment’s products are actually being processed consistent with their pre-approved formulation and labeling, with a special emphasis on the existence (or potential cross-contamination within the production process) of undeclared allergens.

As evidenced by the increasing number of allergen-related recalls, many companies are struggling to consistently ensure compliance. In response, all companies can and should undertake efforts to make sure that they are manufacturing their products in strict compliance with approved formulations and labels. Second, companies must ensure that their products that do not contain allergens are being processed in a way to avoid potential cross-contamination from other products that might contain allergens in their ingredients.

With all that said, congratulations are owed to industry for achieving incredible reductions in the numbers of recalls relating to harmful pathogens. But, pathogens are not the only things that can make people sick. Companies, like consumers, are not immune from the harmful effects of allergens (whether they cause an illness or recall), and should take all precautions to avoid the potentially disastrous effects.

Beef Outbreaks And Recalls Continue To Trend In The Right Direction

Only a few years ago, we would have been hard pressed to see more than a few weeks go by without reading about large scale beef E. coli O157:H7 (“E. coli”) outbreak or recall in the news.

Indeed, as many will remember, 2007 was described as the “Year of the Recall.”   In 2007, there were a total of 22 recalls of beef products involving nearly 35,000,000 pounds. The beef industry, the scientific community, and governmental regulators were all struggling during this period to better understand and also control E. coli in the slaughter and fabrication environment.

Although government and industry began directing more resources toward containing the E. coli problem, the disturbing trends persisted into the following year. Although the numbers of recalls declined slightly in 2008, there were still 17 recalls for E. coli involving nearly 10,000,000 pounds. Although 2009 saw some additional improvement, with only 16 recalls involving only 1,500,000 pounds, nearly one third of the recalls in 2009 were announced because the beef products at issue were putting people in the hospital.

In 2010 and 2011, greater resources were dedicated toward solving the E. coli problem.

In addition to a series of policies announced by FSIS designed to better control pathogens in raw beef products, consumer groups petitioned FSIS to treat non-O157:H7 STECs as adulterants in ground beef. The petition was granted, which reinvigorated the development of more advanced interventions and improved testing methodologies. With increased awareness, and better and more rapid testing methods, more E. coli was being found and diverted before it could enter commerce. The numbers continued to decrease, with less than 1,500,000 pounds of beef products being recalled in 2010 and 2011 combined. In 2010, two of the recalls were associated with human illness, and in 2011 there was only one.

The continued response from government and industry cumulated in drastic reductions of E. coli in 2012. During the entire year, there were only 4 recalls involving only 25,000 pounds of beef. Amazingly, none of those recalls were associated with any human illness.  

Although we are deep into the 2013 fall “E. coli season,” even this year is showing great results. So far, there have only been 5 recalls involving beef (and veal) totaling only 90,000 pounds. It is important to note, however, that three of these recalls (for a total of 75,000 pounds) were initiated by a single company. The fourth recall involved a company that had tested and found 12,000 pounds of its products to be positive for E. coli, but had inadvertently shipped it (before discovering the problem).

Without those two unfortunate irregularities, 2013 would be an almost E. coli-free year.

These trends are not happening by chance. Industry is winning the E. coli fight, and this proves that industry’s efforts have not been in vain. But, with that said, industry can never become complacent.

While the beef industry may be chasing E. coli deeper into the shadows, let there be no mistake: if you let down your guard, even for just a moment, E. coli can and will come racing back.

Aiming For Greener Pasteurs

Science and law have a lot in common.

They are both quite technical, typically managed by people (scientists and lawyers) who over-complicate everything, are both expensive, and are constantly evolving. It is no surprise, then, that the law and the science of food safety have proven in recent history to be exceedingly complex, overly complicated, and in most cases downright costly. They have also evolved drastically.

Only a short time ago, consumers, compliance officers, and courts seemed to appreciate the fact that, in most cases, raw animal products could not be rendered sterile. They also understood that, despite best efforts, industry could not guarantee that these products would be pathogen free. But, when viewed through ever-evolving legal and scientific lenses, expectations have changed.

With respect to the law, USDA first announced in 1994 that E. coli O157:H7 was an adulterant in ground beef, but has in more recent years expanded its “zero tolerance” standard to additional pathogens and additional products. Put simply, more pathogens (from Salmonella to non-O157 STECs) are now being formally and informally declared adulterants in more and more foods.

Science, of course, has evolved as well. Every day, new detection methods are developed, designed to find harmful pathogens with ever-increasing speed and sensitivity. As we all know, the more we test, the more we find. In turn, more positive results will lead to more recalls. This year alone, there have been more than 10 million pounds of meat products recalled for the presence of suspected pathogens.

The broader lesson, which is most often overlooked, is that when recalls are announced, they drive a broadening expectation among consumers that food can and should always be sterile. Indeed, when the USDA reports that an animal product is being recalled for pathogens that “may” be present, the agency is really sending a message that any animal products not being recalled are bacteria-free.

So, what does any of this this have to do with greener pasteurs?

Well, it’s the somewhat novel concept of pasteurization in the meat industry. Having watched the law and science of food safety evolve over the last decade, I am convinced that in coming years consumers will increasingly demand that the raw foods they eat will be more natural, more wholesome and more safe. In turn, I believe that consumers will increasingly expect (and that the market will increasingly demand) that raw products in every instance be rendered pathogen free. 

Food safety shouldn’t create a competitive advantage, but as technology improves, the law crystalizes and consumer expectations evolve, companies will increasingly distinguish themselves by the quality and safety of their products. Whether through the use of irradiation on the kill floor, oxidative gasses in beef coolers or other emerging technologies (many of which are being developed), forward-thinking companies should begin embracing these trends and investigating solutions.

While the ability to guarantee a pathogen-free carcass will be good business, it may also, at long last, be only a pasteur away.

The Food Safety Lawyer On Sampling: USDA, FDA and Companion Samples

In recent years, both USDA and FDA have become far more aggressive in their regulatory enforcement activities, inspections of food processing facilities and investigation of outbreaks. As FDA and USDA industry lawyers, we regularly assist companies both avoiding and responding to these issues.

Notably, with respect to meat products, USDA has begun focusing more aggressively on possible connections between slaughter establishments and outbreaks or positive regulatory ground beef samples. Under the Systems Tracking E. coli O157:H7 – Positive Suppliers (“STEPS”) framework, USDA will in many instances take action against establishments that repeatedly appear in the STEPS system. This can take many forms, ranging from intensified sampling to a Food Safety Assessment (“FSA”) for cause.

If USDA decides to conduct environmental sampling, companies are always welcome to take their own “companion” or “sister” samples. With that said, I do not believe there is any benefit to actually doing it. If an USDA environmental sample tests positive, the agency will not care whether a companion sample tests negative. Contamination is not always distributed evenly, and testing sensitivities will often vary. Thus, FSIS will in all instances treat its own result as a “positive finding.”

The same general rules apply with respect to environmental sampling, whether being conducted by USDA or FDA, for other pathogens like Salmonella or Listeria. In the event of a positive, the government will likely not care about a negative companion sample, and will rely on its own results. Moreover, what happens if the agency sample tests negative, and the companion sample tests positive?

Thus, here too, I do not see any compelling benefit to always collect companions. Moreover, this also avoids the complexities of determining whether to hold, test or even destroy companion samples in the event a governmental sample proves negative.

With that said, if a company thinks that it may someday want to take companion samples when USDA or FDA performs its own testing, I would strongly urge that the company adopt a written policy governing the specific circumstances under which such samples will be taken. This, of course, would apply to both FSIS environmental and finished product sampling.

Such a policy should clearly define the limited circumstances under which companion samples will be collected, and state that those samples will ONLY be tested in the event of a FDA or USDA positive. In this regard, the policy should articulate that the company will rely upon the governmental findings (and it really has no choice), while at the same time setting forth the justification for performing companion testing (i.e., in the event of a finished product regulatory positive to assist in the determination of the ultimate source). The policy should also make clear, however, that if the FDA or USDA sample tests negative, the companion sample will be discarded within a set period of time (i.e., 24 hours).

If a company adopts such a policy, and then closely follows that policy, it should be able to avoid any second-guessing from the agency (or a trial lawyer in a future lawsuit) if a subsequent issue arises or a recall later occurs. Moreover, assuming the policy provides the underlying justification for the protocol to be followed (which it should), I also think any moral obligation to test a companion sample in the event of an agency negative simply falls away.

Food Safety Labeling: Putting Rare Steak On The Chopping Block

Like most people, I enjoy a good steak.

I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, USDA is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell.

These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of 6 E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These 6 outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically tenderized medium rare steaks in restaurants may no longer be a legal option.  As a food safety lawyer, I of course decided to delve deeper into the new proposed regulations.

Notably, time, and temperature, will ultimately set the standard.  This is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. The USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer.

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product.

On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?

Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either: (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely.

In in the end, “medium rare” may become much more rare you think.

Food Safety Lawyers Featured By The National Law Journal And Corporate Counsel Magazine

The law firm of Gass Weber Mullins was recently named by the National Law Journal on its recent "Top Ten List" of law boutiques in the country, based upon the firm's work representing numerous food and other companies on a wide variety of issues throughout the nation. 

The honor comes on the heals of additional recent recognition, where the firm, along with national food safety attorneys Shawn Stevens and Ralph Weber, is featured in Corporate Counsel, American Lawyer Media’s national in-house counsel magazine.

               

The article recaps the firm’s multiple nationwide trial victories, including a one-year stretch starting in August, ’11 when Gass Weber Mullins “put together a 7-0 streak of trial wins from Maui to  Maine" on a diverse mix of commercial, insurance and food safety cases.

In addition to profiling the firm's broad array of litigation work for clients generally, the article also explores the firm's recent victories for the food industry.  The firm's food safety team works nationally with a vast array of food industry clients (including some of the nation’s largest food processors, national restaurant chains, and food distributors and grocers), helping them comply with complex USDA and FDA food safety regulations, responding to FDA inspections (including 483s and Warning Letters) and USDA enforcement actions, enhancing their food safety programs and systems, reducing their food safety litigation risk and exposure, planning for outbreaks and recalls, and defending against high-profile foodborne illness outbreaks and claims.

Impressively, Gass Weber Mullins is one of the only law firms in the nation with such a diverse industry-focused food safety practice.

Indeed, while consulting with nearly all sectors in the food industry on ongoing food safety issues, the firm's food safety team was also, at the same time, able to obtain a favorable jury verdict in a high-profile federal foodborne illness outbreak lawsuit tried recently in Portland, Maine.

Corporate Counsel traces the firm’s roots back to a predecessor firm where several founding partners worked in the early 1990s, and who reunited in 2004 to create a boutique firm of lawyers which strives to be the best, not the necessarily biggest.

The firm has set itself apart as a national leader which embraces technology, makes extensive use of jury research, tries high-stakes, complex, leading-edge cases, and consistently delivers outstanding results for clients throughout the country.

The Food Safety Modernization Act for Dummies

There has been a lot written recently about the perceived complexities of the Food Safety Modernization Act (FSMA).

The new requirements are broad and onerous, stakeholders complain. The proposed rules will be burdensome and costly, experts predict. And FDA enforcement will be varied and inconsistent, others warn. And, yes, even I have been at least partially guilty (I will reluctantly admit) of adding my own voice to the growing chorus detailing all the unfavorable features of FSMA.

But, as I continued to think about the problem, I quickly began to realize that none of this commentary is overly helpful for the business owner simply trying to achieve compliance. Most companies don’t really care about listening to experts pontificate endlessly (which has been going on months and, in some instances, years). Instead, most companies just want to be told what they need to do. So, with that in mind, I thought it would be helpful if we started with a blank canvas, and approached FSMA from a different angle. FSMA for Dummies – or, compliance made simple.
To start out, let’s be clear, the general principles underlying FSMA are really quite easy to grasp. In its most basic form, FSMA requires companies to make safe food.

Second, food companies shouldn’t be misled about the difficulty of compliance. How a company goes about making safe food is, well, with just a few exceptions, left up to the company itself.
So far, so good? I hope so. It’s not very difficult.

Next, to actually demonstrate to the FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will expect to see when they show up at the company’s door. Here too, the answer is very simple. Generally speaking, if you process food products using ingredients sourced from suppliers in the US, there will be just a handful of basic requirements.

Indeed, if you are a food company, and if you source your ingredients domestically, you will only be required to show: (1) that you have a written food safety plan; (2) that you have records to prove that you are following your written food safety plan; and (3) that you have a traceability system in place (or, stated differently, that you have records to demonstrate where your ingredients came from, the products in which your ingredients were used, and the customers to whom your resulting finished products were sold). In turn, the key to actually demonstrating compliance to the FDA (when the FDA visits your facility to perform its first FSMA inspection), is to craft your FSMA materials so that they are aligned as closely as possible with what the FDA will “expect” to see. Finally, if you process foods using ingredients sourced from overseas, you will also need to have a folder in your file cabinet (or on your computer) called “foreign supplier verification program.” More on that later. 

As noted, the real cornerstone of FSMA is the development of a written food safety plan. To create your written plan, you will need to conduct a food safety assessment within your facility, identify those food safety hazards that are reasonably likely to occur within your products, and then develop and implement controls (i.e., critical control points) designed to manage those hazards.

It is important to note that the controls you identify will need to be proven effective (i.e., validation), and you will need to create and maintain monitoring records that will prove that your controls are working as intended (i.e., verification). You will also need to develop prerequisite programs designed to ensure that you are following good manufacturing practices, that your employees are following hygienic practices, and that your facility remains clean. Although you can actually write the first draft of your plan, it will ultimately need to be approved by a “qualified individual.” We, of course, can help you there.

To establish compliance under FSMA, companies will also need to adopt a robust traceability system. From a food safety standpoint, it will be very important in the eyes of FDA that all companies be able to identify the source of their incoming ingredients, the specific products in which those ingredients were used, and the companies to whom the resulting finished products were sent. This way, if there is a downstream problem associated with a product, the FDA can immediately trace the product back upstream, and then quickly identify, contain and then solve any potential problems.

So long as your program enables you to accurately and quickly accomplish these goals, the FDA will likely characterize your program as compliant.

Next, as noted above, if you do decide to source any food ingredients from foreign suppliers, you will also need to ensure that those suppliers are complying with each of the FSMA requirements as well. You can demonstrate compliance under FSMA by having a copy of your supplier’s written food safety plan (developed by a qualified individual) in your file. I would also recommend having your foreign suppliers audited annually, and to perform some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Oh, and remember, both your plan and your supplier’s plan will need to be reassessed any time there is a change in any manufacturing process, or at least once annually, whichever comes first.

Finally, although this column attempts to capture the “essence” of what FSMA requires, I would not be doing my job as a lawyer if I didn’t at least offer the following disclaimer: there are at least a few finer rules contained within FSMA not specifically addressed in this column and, regardless of where they are hidden, all of the rules are and will be changing routinely. Thus, as you work to develop your plan, it will be critical to read the Act and ensure you understand each of the federal requirements and the FDA’s corresponding expectations. But, we, of course, can help with that too. 

So, as you march forward toward compliance, rest assured, it really can be quite simple. Put simply: Yes, you CAN develop a written food safety plan and chew gum at the same time … just don’t do it on the production floor.
 

The Apples and Oranges of Occupational and Food Safety Culture

We spend a lot of time thinking about food.

Although we defend food companies in high-profile foodborne illness outbreak lawsuits throughout the country, the majority of our time is spent working with clients to improve the quality of their operations from a risk exposure and brand protection standpoint.

This is our favorite and most rewarding job -- working closely with food companies who, although not necessarily facing a large-scale outbreak or lawsuit, are nevertheless reaching out for advice on how to avoid both.

The easiest way for any food company to produce a safer product (and, by extension, to lower its risk), is to develop and adopt a robust food safety culture. But many companies struggle with the concept because it is too foreign, or they believe it will cost too much.

Many corporate leaders come from places other than the food industry, so they have little experience in food safety, and thus no corresponding desire to invest in the development of a food safety culture.

That’s why I started thinking about ways to address the food safety culture challenge from a different angle. As experts, we can’t just keep telling food companies they have to adopt a food safety culture, we have to help them do it.

So, how do apples and oranges play a role?

Well, we often characterize apples and oranges as being quite different. The reality, however, is that if we take a moment to think about it, the two fruits are really quite similar. They’re about the same cost, the same size, the same shape and the same weight. And, they’re usually placed in the same drawer in our refrigerator. To appreciate the significant parallels, we only need to open our eyes a little bit wider.

The same is true when it comes to the concepts of culture-driven workplace safety and food safety.

Most corporate leaders are intimately familiar with the concept of occupational safety. Notably, in virtually every workplace in America, the concept is driven home constantly. Everyone knows it, everyone gets it, and everyone accepts it.

And, most important, the language and messaging used to teach workplace safety is eerily similar (if not in most cases identical) to the language and messaging used to promote food safety culture. These parallels make the job of promoting a strong food safety culture in any organization exceedingly simple.

Indeed, companies can start down the road of developing a culture-based food safety program by taking all of their workplace safety placards, Powerpoints, videos and training materials used for occupational or workplace safety, and inserting the word “food safety” instead. Employees will understand it, management can teach it, and corporate leadership may even embrace it.

Although apples and oranges may look different, I would argue they sometimes fall from the same tree.

Preventing Outbreaks And Recalls Is Becoming A Very "Hot" Topic

Can anyone really guarantee that their products will never be implicated in a recall?

For most raw beef processors, the response has consistently been that, in the absence of a validated intervention like high pressure processing or irradiation, such a statement was impossible.

Interestingly, however, processors may have more control than they think. Increasingly, the existence of positive regulatory findings on the one hand and outbreaks on the other are being linked objectively to identifiable events occurring in slaughter plants themselves.

Indeed, FSIS believes there is a direct correlation between hot days or high event periods (HEPs) in harvest facilities and E. coli O157:H7 findings. A high event period is a period during which the number of beef combos in a slaughter facility that test positive for E. coli O157:H7 is higher than expected, and thus may be a signal of a food safety failure and product cross-contamination.

As a result, FSIS has in recent guidance documents urged slaughter facilities to develop, implement and then closely follow a HEP program. In essence, these programs require slaughter facilities to take certain actions when their E. coli O157:H7 (or, non-O157:H7 STEC) findings exceed a certain threshold. Such actions can include retesting all negative product, or diverting all potentially affected trim to a renderer or validated cook facility.

Rather than just relying on FSIS to urge slaughter facilities to develop and follow HEP programs, processors should actually mandate that their suppliers adopt them. This way, if your supplier has an issue, you can ensure that his or her issue does not become your own. In turn, such requirements can and should be built wherever possible into your supplier specifications. Given what science has demonstrated, requiring your suppliers to respond appropriately to a HEP pursuant to established procedures will likely decrease your risk of being drawn into a recall substantially.

Finally, the analysis does not necessarily end there. Whenever a slaughter facility has an O157:H7 positive (whether operating under a HEP program or not), that facility should be urged to identify and divert any associated product. Put another way, if contamination exists in one lot, the flanking lots which test negative might be diverted as well. This is because, if E. coli exists in one lot, it may also be present at undetectable levels in adjoining lots as well.

So, what’s hot – and what’s not? Well, by casting a much wider net and diverting all potentially affected product in the event of a positive finding, the risk of any contamination leaving the facility undetected (and the chance of a future recall) can be reduced substantially as well.

Ensuring Compliance Under The FDA's New Proposed Food Safety Rules

The Federal Food and Drug Administration (“FDA”)  has finally published its long-anticipated proposed rules on Preventive Controls for Human Food (written food safety plans) and Standards for Produce Safety. 

According to the FDA, the two rules “are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (“FSMA”).” 

The agency also claims that the new proposed rules “build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.”   

FDA also expects to soon issue its proposed rule on importer foreign supplier verification.  In the words of the agency, future proposed rules will address preventive controls for animal food, and also accreditation standards for third-party auditors.

In the paragraphs that follow, we take a few moments to break down the new rules into their most basic form.

Written Food Safety Plans (“HACCP”)

The most anticipated element of FSMA has been the requirement that all FDA regulated food companies develop and implement written food safety (or, HACCP) plans.  The proposed rule on preventive controls for human food (i.e., requiring written food safety pans) would apply to all facilities that manufacture, process, pack or hold human food. In general, with only some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations.  With that said, it will be critical to consult with legal counsel regarding the applicability of the new rules, as certain exemptions and modified requirements have been established for some discreet segments of the industry.

In its most basic form, the new FDA rule requires that firms develop and implement written food safety plans to identify potential food safety hazards, put into place steps to address those hazards, verify that the steps are working, and outline how to correct any problems that arise.  Under the new requirements, the written food safety plans should, at a minimum, include the following:

  1. a hazard analysis;
  2. risk based preventive controls;
  3. monitoring procedures;
  4. corrective actions;
  5.  verification procedures; and
  6. record keeping.

In addition to creating plans that will pass the scrutiny of FDA, food companies will also need to demonstrate that these plans have been designed by a “qualified individual.”  In this regard, please contact us for additional information on this requirement, as well as each of the discrete additional regulatory requirements food companies will need to satisfy in order to demonstrate full compliance with FDA.  Click here to view a copy of the Proposed Preventative Controls Rule.

Future proposed rules will address importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

New Produce Compliance Rules

In addition to publishing its proposed rules governing written food safety plans, FDA has also unveiled new rules governing produce production.  The new FDA proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing designed and validated to eliminate or reduce known pathogens.  The proposed rule focuses on various known areas of risk, and promulgates standards for the following:

  1. agricultural water;
  2. biological soil amendments;
  3. health and hygiene;
  4. domesticated and wild animals; and
  5. equipment, tools and buildings.

The proposed produce rule is, according to the agency, the result of extensive outreach by FDA with consumers, government, industry, researchers, and many others.   FDA has also stated that the produce rule is aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not conflicting with laws and rules for organic farming.

With that said, it is important to note that certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year during the last three years (adjusted for inflation), and if their sales to qualified end-users exceed their sales to others during the same period.  Moreover, according to the rule, any farms whose average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule.  Such farms would still be responsible for the safety of their produce, however, and the FDA maintains that the exceptions can be revoked under certain circumstances.  In addition, states and foreign countries will be permitted to seek variances from provisions of the rule because of local growing conditions.

Although the rule is still in its draft form, the general compliance date is currently anticipated to be two years after the effective date of the rule . For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date. Additional time would be allowed for compliance with certain water requirements.  Click here to view a copy of the Proposed Produce Rule.

Although FDA intends to publish various guidance materials to help industry meet the new requirements, the success of your business will ultimately depend upon your ability from a legal standpoint to demonstrate to FDA that you have achieved full compliance.  In this regard, please feel free to contact our firm for additional insight and information regarding the new proposed rules, and how to best (and most efficiently and quickly) satisfy the new requirements.

Brand Protection Requires More Than Wishful Thinking

When it comes to the production of food, it is the things industry can’t see which industry fears most.

Lurking somewhere in the darkest corner of a hot box, in the silent throes of a sales cooler, or in a case-ready package being staged for delivery, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

For more than a decade, our firm has worked closely helping the meat industry with crisis management, regulatory response and complex litigation following large-scale outbreaks and recalls. The unfortunate reality from a business perspective is that, in a disturbing number of instances, when outbreaks and recalls occur, the companies that are involved cease to exist.

Watching innumerable outbreaks unfold over the years, our firm has gained a deep understanding about the science of food safety, the epidemiology of foodborne illness outbreaks and the legal consequences of food product recalls. We have also gained far-reaching experience analyzing why recalls occur in the first instance, and how they, in many instances, could have been avoided.

While all companies want their customers to believe that their products are as safe as possible, and try to communicate this fundamental message through their brand, in today’s world success requires more than just a good advertising campaign. In order so sell food safely, a company needs to demonstrate it can process a safe product. In order to process a safe product, the company needs to invest in making it a reality. Food safety, unfortunately, doesn’t just “happen” by itself.

Thus, when working to protect the interests of my own clients, I usually start with a Brand Protection Audit. Usually, I can accomplish what I need in just a single day. I like to interview employees to learn more about the company’s real food safety culture, and review food safety training materials to suggest improvements. I also like to assess a company’s written food safety plans, and look for hidden gaps that create additional exposure. Moreover, many companies are surprised to find out that their policies are not actually being executed as written.

In addition, companies can easily developing stronger and more effective supplier specifications, and indemnity agreements, that provide added protection, as well as ensuring that existing insurance coverage is sufficient to cover potential liabilities. We also work closely with companies to develop and then conduct mock recall training, in as close to a real-world scenario as possible, to test their ability to trace and also contain a potential problem.

Finally, we provide advice to our clients on to best respond to government-issued NRs (so as to avoid criticisms months or years later from a judge or jury), and also prepare for and respond to both routine and for cause Food Safety Assessments. Many companies simply do not realize that what they say today can (and always will) be used against them tomorrow.

With that said, merely creating the “image” that you care about food safety is no longer enough. History has taught us that by taking a few additional proactive steps right now, such as auditing the true depth and survivability of your brand (i.e., the Brand Protection Audit), companies can significantly and strengthen the trust in, and longevity of, their most important assets – their image and their brand.

Incentivizing Food Safety [PART I]

Not a single day goes by when we don’t hear about the critical importance of food safety.  We need to develop, embrace and encourage a robust food safety culture, we’re told.  We have to tirelessly reassess and verify the effectiveness of our food safety programs, we’re led to believe.  We have to invest in, and then build into our facilities, the best leading-edge interventions.  And, we have to implement and invest in an increasing level of environmental and food product sampling and testing, its suggested. 

That all sounds really great, but the reality is that we face substantial underlying fundamental problems when it comes to improving food safety.  Each of the items I describe above cost money.  Some of them, like new infrastructure to support new interventions, cost a lot of money.  And, what happens when our competitors are not investing in these initiatives.  Well, our competitors can sell a lot more product for a lot less money, and they will have a substantial economic advantage.  And, a disincentive for food safety.

Set economics aside.  What happens if companies who are aggressively testing finished products for pathogens actually find them (and, trust me, they will).  Well, in most instances, a positive finding in a finished product will trigger a protracted and uncomfortable governmental response requiring proof of containment (when, in some instances, it’s nearly impossible to convince the government of anything). These companies will also in many instances be subjected to undeserved, drawn-out scrutiny of their operating programs. 

The end result is that, while company A (which tests for pathogens) struggles for days or weeks to survive USDA’s criticism and scrutiny after finding them, Company B (which does not test for pathogens) will keep shipping contaminated product under the watchful eye of USDA.  Why test, these companies might ask, when testing only creates more regulatory problems? So, we see yet another significant disincentive.

So, where is the incentive for competitors to invest more deeply in food safety?  Well, we should all be doing what we reasonably can because it’s the right thing to do.  But, we also need some help from an economic and regulatory standpoint.  USDA needs to encourage the development and use of new technologies and testing programs, and then aggressively reward those companies that use them. 

In next month’s column, I will detail some ideas that can help reverse this paradigm.  And, while you may have to wait until then to hear what it is I have to say, I hope I’ve created at least some incentive for you to return – for the sake of food safety.

Incentivizing Food Safety [PART II]

In our last column, we introduced some of the fundamental challenges facing the food industry as it works to improve food safety. 

Some of the greatest challenges, when it comes to food safety, are driven by basic economics.  This is because improving food safety, in most cases, costs money. 

Unless everyone in the industry is investing in the same food safety systems, those companies that spend more money will (at least in the short term) face a substantial competitive disadvantage when compared to those companies that do not.  Moreover, companies that aggressively search for and then find pathogens will, in most cases, face more governmental scrutiny than those that do not. 

So, what can we do about it?  As I mentioned last month, industry really needs additional help from an economic and regulatory standpoint. 

FSIS can start by reconsidering its new, soon to-be-announced rules that, reportedly, will require ALL processing companies, without exception, to place validated cooking instructions (designed to address harmful pathogens) on mechanically tenderized steaks.  Unfortunately, if enacted as proposed, the new rules would actually create a disincentive for food safety.

Indeed, not all processors are created equal.  Requiring ALL processors to carry the same validated cooking instructions (thus passing their own exposure to end-users downstream) could create significant disincentives for more companies to invest in new interventions designed to actually eliminate pathogens.  In my view, the solution lies in crafting the new rules so that processors will be EXEMPTED from the labeling requirements if they employ a validated intervention designed to address the risk.  If this could be accomplished, the large restaurant chains (the real drivers in the market) would invariably move toward and embrace products that: (1) are subjected to those interventions; and (2) as a result, exempted from the new cooking labels and requirements.

Government should also consider tax incentives for testing and finding pathogens in food.  Indeed, testing for (and then finding) pathogens can be very expensive.  This is because establishments that test raw products are required to divert positive product to cooking or rendering. Common sense tells us that the harder companies test, the more pathogens they will find, the more product they will divert and the more revenue they will lose.  Thus, of course, creates a significant disincentive to test and find.

So, is there a better way?  I think so.  For starters, I would counsel FSIS to reward (not punish) companies that aggressively test to find pathogens in their products.  Next, I would urge legislators to expand existing tax incentives (there are already some) for testing, research and quality control.

Finally, I would lobby for the creation of meaningful tax credits which would extend to any products affected by contamination and then diverted from their original intended use.

These, of course, represent just a few ideas to chew on.  In the end, we all know what we need to do – the problem is that we just need a few, extra incentives to get there. 

Is it time yet for a single food safety agency?

Our national food safety system traces its origins to the beginning of the 20th century, when there was virtually no oversight of our food production.

In response to a growing movement questioning the quality and safety of meat products, Congress enacted the Wholesome Meat Act in 1967, and the USDA hired and deployed federal inspectors to slaughter plants throughout the nation. The federal inspector’s job was to ensure through visual inspection that our food was being produced under sanitary conditions. Today, these inspectors remain in every federally inspected meat and poultry establishment in the country. While their mission has not changed significantly, the environment in which they accomplish it has.

Scientific and technological advances over the past century have revolutionized our understanding of pathogens and the causes of foodborne illness. Microbiologists, physicians, veterinarians, farmers, government regulators, and engineers have all worked together to develop the most effective food safety apparatus yet. The results have been largely responsible for a substantial decline in the number of foodborne illnesses in recent years.

In spite of the improvements, increased scrutiny has been placed on the food industry by the public, the media, and politicians, many of whom argue that even a single foodborne illness is entirely unacceptable and that more must be done regardless of the difficulties involved in detecting and preventing the presence of microscopic organisms.

The government answered these calls, in part, with the recent passage of the Food Safety Modernization Act. The act, which legislates the largest expansion of the FDA’s food safety authority since the 1930s, has been hailed as the most comprehensive piece of food safety legislation ever enacted. It seeks to radically transform the regulatory landscape for thousands of American and international food companies through the implementation of new requirements and a broad inspection apparatus ostensibly designed to ensure the safety of American food.

Unfortunately, the new legislation is, at least for now, effectively stalled. Many foresaw the difficulties in implementing the FDA’s wide-reaching reforms and, almost immediately upon passage of the law, began asking where the FDA would acquire the resources necessary to implement its dramatic reforms.

At a recent conference hosted by the International Association for Food Protection in Providence, R.I., participants were told by an FDA spokesperson that many of the FSMA regulations had not yet been finalized. In addition to budgetary shortfalls, substantial trade difficulties are rumored to have arisen over requirements placed on foreign establishments. He further explained that, despite the lack of progress, everything under the new FSMA remains in a “deliberative phase.” What that means remains to be seen.

What is clear is that concerns over another international economic collapse, spiraling national debt (which has already resulted in, among other things, the U.S. losing its AAA credit-rating), and the realization that government spending must be reined in immediately have resulted in what amounts to the possible economic infeasibility of the FSMA in its current form.

Critics have long argued that the government’s tendency to throw money, rather than solutions, at difficult problems would result only in a bureaucratic colossus. That now seems to be the case. The Government Accountability Office, for instance, recently identified as many as 15 separate federal agencies collectively administering at least 30 laws related to food safety.

Consider that in the U.S. Senate, the committees on agriculture; nutrition; forestry; homeland security and governmental affairs; and health, education, labor, and pensions are all actively involved in making decisions relating to food safety. In the U.S. House of Representatives, the committees responsible for making decisions include agriculture; energy and commerce; over­sight and government reform; and science. Agriculture subcommittees of the House and Senate Appropriations Committees also play oversight and funding roles in how the major agencies carry out food safety policies. The potential for waste and redundancy under such a system is obvious.

In 2011, the FSIS received more than a billion dollars in appropriated funds, plus another approximately $150 million in industry-paid user fees. Yet, these two organizations have jurisdiction over only 10% to 20% of the U.S. food supply. FSIS employs a staff of more than 9,000 workers, approximately 8,000 of whom work in the roughly 6,300 meat slaughter and/or processing plants nationwide.

Processing inspection does not require inspectors to remain on the production line constantly or to inspect every single food product. Rather, inspectors are tasked with the responsibility of verifying a plant’s adherence to its HACCP program, examining its standards for sanitary conditions, ingredient levels, and packaging, and conducting occasional microbiological sampling.

Perhaps, the time has come to change the way we think about food safety. And, perhaps, nothing less than a complete overhaul of our national food safety apparatus would allow us to take the next big step forward.

How It Would Work

We have arrived at a fork in the road to safer food and are faced with the choice of continuing on the path we’ve taken—adding more rules, regulations, and oversight with the hope that we will reach a point at which foodborne illness disappears—or going in a different direction. The law of diminishing returns tells us that that in all productive processes, adding more of one factor of production (regulations and inspectors) while holding all others constant will at some point yield lower per-unit returns.

Thus, the real solution to this problem will most likely be achieved scientifically, not bureaucratically. Continuing to spend enormous sums of money on redundant, antiquated, and ineffective solutions is irresponsible and self-indulgent. Inspectors and laws are incapable of seeing microscopic pathogens. Government will still play a critical role in the design and implementation of an overhauled food safety system. But, it may be time to come to terms with the reality that pragmatism and science, rather than bureaucrats and legislation, make food safer.

The first step in setting an overhaul into motion should be the formation of an independent panel that is tasked with a top-down review of government food safety expenditures that focuses on waste and redundancy. Simultaneous studies aimed at identifying and developing a more streamlined inspection apparatus should be commissioned by experts in the field of science, technology, agriculture, and engineering.

Technology is increasing at a rate never before seen. Government should, for the first time in history, set the table for new discoveries in anticipation of the continued occurrence of existing and emerging pathogens. There are enormous changes on the horizon as a result of globalization, possible climate change, and financial challenges across the world. The results of these changes will lead to a far more dynamic environment surrounding the food industry. If we do not substantially modify our food safety systems, it is likely that neither the food industry nor government will be able to effectively address new and emerging issues relating to food safety.

In turn, many of the problems we face are likely better addressed by privatizing parts of the U.S. food inspection system. American companies have long partnered with industry through auditing, consulting, and inventing to bring cutting-edge technology into food processing environments.

Moreover, we are seeing a dramatic increase in the amount of imported food we consume. This trend is expected to continue into the foreseeable future. The lack of jurisdiction held by the FDA and USDA outside of the U.S. poses a unique problem that could be solved quickly if the government allowed U.S. companies to conduct inspection and verification activities on its behalf.

The inspectors themselves would have to be drawn from those currently working for the USDA and FSIS, providing what would essentially be a lateral transfer from the public sector to the private. Companies interested in doing the inspections would bid on the jobs, thus providing the best cost-effectiveness ratio possible while simultaneously promoting private sector research.

The infrastructure is already in place to begin implementing privatized inspection. The FSMA, which is currently stalled partly because of its massive size, provides a perfect place for government to begin transitioning inspection responsibility to the private sector. This solution would address the food safety concerns that the FSMA hoped to solve, while at the same time allowing private sector creativity and ingenuity to generate the most cost-effective means of implementing the law. As it stands today, the law is untenable. Privatization provides a means to enact the legislation and save money doing it.

The emergence of new technologies allows for faster, better communication, more effective microbiology, and improved food safety. Indeed, the calls for increased inspection are rapidly outpacing the capacity of government to implement them. Privatizing inspection with governmental oversight makes sense. It is likely that the necessity for in-line human inspection will soon be obsolete as advances in affordable robotics, information technology, and optics begin to outpace human capability.

We have seen more technological advances in the past 100 years than in the previous 50,000. All indications are that this exponentially increasing rate of growth will continue for the next century and beyond. This technological explosion, if continued at current rate, suggests that the changes in the next 20 years will exceed the collective advances of the entire 20th century. The prospect of such immense change is difficult for most people to grasp, but empirical data are difficult to dispute. If it is even close to accurate, the vast advances currently on the horizon in information technology, medicine, robotics, and nanotechnology could result in an end to disease, foodborne illness, and perhaps even world hunger.

It is incumbent upon us to maximize the implementation of technologies that can prevent illness, yield more food, and preserve resources. Allowing government to continue to bloat and expand while providing diminishing returns is inefficient, ineffective, and counterproductive. Technological, scientific, agricultural, and socio-economic changes have reached a confluence where great changes are not only possible but also necessary. Now is the time to act if we truly want to modernize American food safety.

The True Benefits of Consumer Confidence in Food Safety

FDA’s Deputy Commissioner for Foods, Michael Taylor, recently addressed the issue of the consumer confidence in food safety at China’s International Food Safety and Quality Conference last week.

Taylor described the issue as “an important goal in its own right.” He stressed the issue is just as important as public health in regards to food safety. Taylor argued that we all benefit if we do not have worry about food safety. In turn, although Taylor pointed out that most consumers know that food is not 100% risk-free, he did explain that they expect a certain “basic level” of safety.

During the conference, Taylor also described the economic impact that consumer confidence can have on the industry as a whole. He stated, “it provides the foundation for the growing global trade, as well as robust domestic markets that are open to innovative products and technologies.” In contrast, he explained what happens when consumer confidence is lost. If a company’s product results in an illness outbreak, the company pays the price: they lose consumer confidence and profit. Often times, assuming the company survives, it can take a significant amount of time to rebuild consumer confidence.

Taylor also discussed how countries are revamping their food safety programs to help enhance consumer confidence abroad. Examples of these countries include: Canada, the Dominican Republic, and Vietnam. Taylor explained how the role of government is vital in aiding these new food safety initiatives. They can, in the end, and if done right, provide very “credible and effective” oversight.

Ultimately, Taylor stressed how it is the industry’s commitment and responsibility to food safety that will ultimately affect consumer confidence. As we always say, if industry continues lean forward in the food safety foxhole (as opposed to looking for ways to hide in it), both industry and the consumer will be better off.
 

New Food Safety Authority in Africa

A team of international food safety experts recently met to set the basic framework for a food safety authority in Africa.

The meeting was hosted by the Interafrican Bureau for Animal Resources in Rwanda. The focus was on how to carry-out the African Union Commission’s (AUC) plan for a pan-African food safety program. The AUC would like to model their program after the European Food Safety Authority.

The center of the program will be on safety standards and to monitor food supply in Africa. During the meeting, they addressed need for such program, the objectives, structure/functionality, as well priorities and an implementation road map. There was also discussion of creating a Rapid Alert System for Food and Feed (RASFF) program in correlation with the authority. Notably, the European Union implemented a similar program back in 2002. This RASFF would act as a forum to share information about companies who produce products that might be of risk to consumers.

With the new program, AUC is hoping to increase standardization throughout the region which will, in turn, increase trade. Although the new authority is still in the planning stages, it looks like the initiative will continue to gain traction.
 

New National Food Policy Scorecard

A new scorecard for lawmakers was launched by the advocacy group, Food Policy Action.

The National Food Policy Scorecard will grade lawmakers on food issues relating to food safety, hunger, farm subsidies, farm workers’ rights and humane animal treatment. Other heavy-hitters in the food industry are backing the movement, such as Top Chef Tom Colicchio, Stonyfield Farm’s Gary Hirshberg, and Robin Schepper, the former executive director for Michelle Obama’s “Let’s Move” campaign.

The scorecard looked at over 30 key food policy votes in Congress. Lawmakers were rewarded for voting on initiatives to reduce or eliminate federal subsidies paid to farmers, boost E. coli prevention funding, and that repeal ethanol subsidies. However, they were penalized for voting to reduce food assistance or weaken pesticide regulations.

Food Policy Action feels that despite Democrats out-scoring Republicans, the food scorecard is objective and non-partisan. Scott Faber, VP of Environmental Working Group said, “Food is a bipartisan issue.” Adding that, “some Republicans scored well and Democrats scored poorly.” Others chimed in saying “it isn’t about politics, it’s about values.”

Food Policy Action’s mission is to increase awareness about food policy. More specifically, they want to promote policies that encourage “healthy diets, reduce hunger at home and abroad, improve food access & affordability, uphold the rights and dignity of food and farm workers, increase transparency, improve public health, reduce the risk of foodborne illness, support local and regional food systems, treat farm animals humanely and reduce the environmental impact of farming and food production.”

It is not set on how the scorecard will be implemented. Only a few media outlets have reported the results from the scorecard released this past Wednesday.
 

National Food Day 2012

Following the success of last year’s first Food Day, this coming October 24, 2012 will mark the second annual National Food Day. It is organized by the Center for Science in the Public Interest (CSPI), along with other leaders in the food industry, activists, and others from all across the country. The ultimate goal is to unify the nation’s key stakeholders to promote improved food policies. The campaign also addresses additional issues including: health and nutrition, hunger, agricultural policy, animal welfare, and farmer work justice (just to name a few).

Promoters of the initiative believe that food should bolster one’s health, not hinder it. Thus, a primary goal is to promote healthier, more affordable, and more sustainable food. In turn, there are many “Food Day” events occurring on October 24, 2012 throughout the country. To find out what events are happening near you, you can go to the Food Day website: http://www.foodday.org/all_events.

England Warns About The Use Of Liquid Nitrogen In Cocktails

England’s Food Standards Agency (FSA) released an official warning in response to the increased use by many commercial establishments of liquid nitrogen in cocktail drinks.

The warning was issued after a young woman celebrating her 18th birthday consumed a drink containing liquid nitrogen and became very ill. She had complained of trouble breathing and stomach pains. Doctors found that her stomach had been perforated and performed immediate surgery. The young woman is now recovering, after having most of her stomach removed.

Liquid nitrogen is non-toxic, but if misused can pose a serious threat to humans when ingested. In order to serve liquid nitrogen properly, one has to make sure the liquid has evaporated completed. If served too quickly, risks of frostbite, cryogenic burns, or more serious issues arise.

The FSA is taking steps to make sure local enforcement officers are aware of the practices using liquid nitrogen in cocktails. In addition, they will be working with law enforcement agencies to investigate these issues further.

Colin Houston, an FSA official stated, “There are safety guidelines around the use of liquid nitrogen, especially in relation to food.” He continued to explain that, if it is used in any form, it is the business owner’s responsibility to ensure their staff is trained and educated on the risks of use.

The wine bar that served the drink to the young woman has stopped serving drinks with liquid nitrogen.

Ironically, doing so may help them avoid additional heat.
 

Food Safety Training Lab

The International Food Safety Training Lab (IFSTL) has experienced excellent results after only one year of operations. The lab is designed to train scientists globally in top food testing methods.

IFSTL has also opened up its doors to trade policymakers and other industry professionals. The overall goal is to improve food safety quality on a global scale. Advocates feel that, by helping foreign suppliers better understand efforts in the US to control potential food contamination, foreign exporters can better understand how to comply with the related US requirements. In addition, policymakers can learn more information about food safety practices to make better informed policy and trade decisions.

The lab is operated by the University of Maryland along with the FDA. Both FDA scientists and guest lecturers from the industry help run the lab. The director of IFSTL, Jane Dubois explains that students get a “one-on-one interaction with FDA, USDA and EPA specialists.” Dubois also adds that, “by learning to use internationally recognized testing methods students are able to verify whether a product meets a country’s standards, even if those standards vary country-to-country, because the method [being used] is universal.”

Currently the program is working on E. coli related research, including a more detailed look into the “Big Six.” In November, the lab is planning on conducting a course on microscopic identification of ingredients that will allow students to determine whether or not an ingredient is truly what it purports to be on the product label. A second lab is set to open in England in 2013.
 

BPI Fights Back

Beef Products Inc., a company which was recently subject to vicious and misleading attacks by ABC News, is fighting back.

The company filed a lawsuit Thursday seeking $1.2 Billion in damages for losses it alleges it sustained after ABC aired a series of stories attacking the company.

The series, which drew tens of millions of viewers, has been widely rebuked by the meat industry, the USDA, senators, governors, and, perhaps most tellingly, a number of consumer food-safety advocacy groups. Articles appearing in the NY Times, USA Today, The Wall Street Journal and Food Quality Magazine (The Battle Over Pink Slime), among many others sought to defend BPI as a safe and innovative company making a healthy product. Unfortunately, by that point, it was too late to save BPI from taking substantial losses. The company was forced to suspend operations at three of its four plants.

Jim Avila, who reported the stories, has been named as a defendant in the case, as have Diane Sawyer and former USDA employee Gerald Zirnstein. Proponents of BPI contend that the withering attacks were dependent upon the use of misleading information and emotive keywords and phrases like “Pink Slime.” Today, in spite of compelling evidence supporting BPI, ABC News is not backing down. Jeffrey W. Schneider, Senior Vice President, ABC News said in response to the filing, “The lawsuit is without merit. We will contest it vigorously.”

Indiana to Publish Raw Milk Safety Standards

Indiana will be adapting new standards for raw milk production, if the state decides to legalize the product.

Indeed, the Indiana Board of Animal Health (IBOAH) has until December 1, 2012 to give recommendations on raw milk policies to the Indiana Assembly.

A virtual public hearing was conducted between June 1 and Sept 1 this year. They received over 600 comments in support of raw milk. Due to this turnout, IBOAH has shared the report request by Indiana Legislature with the Governor. With the ample support, IBOAH will now include a “Plan B,” which will include adapted standards if raw milk is legalized.

IBOAH spokeswoman Denise Derrer stated, “[w]e’re basically creating a Plan B and submitting to legislators to tell them if you decide to legalize the sale of raw milk, here is the way we think it should happen.”

Indiana would join the state of Wisconsin in these new regulations. Wisconsin came up with very specific regulations making raw milk safer (if the state decided to legalize raw milk). These measures included testing for disease, plate count, somatic cell count, coliform bacteria in well water, and testing of pathogenic bacteria. In addition, Wisconsin wanted on-farm sampling, incident plans, and regulations for raw milk containers, such as labeling requirements.

Indiana was close to making raw milk legal earlier this year. Instead they opted to go with an outside advisory report. Indiana is ranked the 14th largest diary state by milk product. Notably, since Wisconsin adopted raw milk safety regulations, no raw milk bill has passed in the state legislature.
 

FDA's Newest Egg Guideline

The FDA has released its first new guidance materials since implementing the “Egg Rule” in 2009. The Egg Rule was aimed at reducing Salmonella in shell egg shells. The FDA said this week they are using guidance documents to help companies best comply with food safety rules.

In the past 3 years, the FDA has inspected many large and medium sized egg operations nationwide, with the exception being smaller egg producers. However, they will now too have to comply with the new rule.

In essence, the FDA intends to treat poultry houses and the surrounding areas as a “single biosecurity program.” With this holistic approach, it would mean that that a broad-reaching “Salmonella Prevention Plan” would have to be implemented at these facilities (which the egg rule lays out). Certain guidelines include treating food and water on the grounds and applying antibiotics to birds.

Concerns have risen in respect to smaller companies, however. Especially companies who follow a more traditional approach, meaning that they use open land. This open land can be more difficult to regulate, however. Some feel these types of producers will have a harder time complying with the Egg Rule.
 

Europe Holds Off On Aspartame Review

The European Food Safety Authority (EFSA) will not be releasing its “full re-evaluation” of the sweetener, Aspartame, next month as scheduled.

Instead they have asked the European Commission (EC) for an extension, which would push the release to 2013. The extension would allow for consideration of new scientific data and research. As well as give time for a complete compressive risk management of the product. Originally the re-evaluation was not scheduled to be released until 2020, however the EC asked the EFSA to make an early release in 2012.

Since the requested early release date, EFSA has called on the public for scientific data for a “thorough literature review.” So far there was little data showing potential DKP (a byproduct of aspartame that has been linked to brain tumors) and other degradation products of aspartame. Therefore the EFSA would like to see more data.

Controversy has arisen over the past couple of decades over the sweetener. Some have claimed it causes health issues such as brain tumors, epilepsy, birth defects and even cancer. As of now aspartame has been proved safe. EFSA certified aspartame last in 2009. The FDA in the US first approved aspartame in 1974.
 

Food Safety: Seeking More Data on Antibiotics

Earlier this week, senators wrote a letter urging USDA Commissioner Margaret Hamburg to have the FDA collect more data on antibiotics used in food animal production.

Currently, the agency does not collect data about veterinary drug usage. Even though the FDA requires reports of antibiotics sales, there is no dated collected to identify the specific animal species being treated with antibiotics, and how much they treated with (in regards to disease prevention, growth promotion, and therapeutic treatment). Many feel that, without this data, it is difficult for stakeholders to correctly assess whether the industry is actually reducing its usage of antibiotics in animals for food production. Both scientists and public health advocates agree having such data would help fight antibiotic resistance.

The letter suggests that the agency create a system for gathering and analyzing information to assess the effectiveness of new antibiotic policies. Senators offered to work with the FDA to provide additional authorities and/or resources, if needed. The letter also recognized the steps the agency is taking to address existing concerns, like revising labels and increasing oversight of antibiotics. However, they stressed the concern about continuing ambiguity in existing programs. Although there has been no official response to letter, we wait in earnest for the FDA’s view on these issues.
 

Canada Moves Toward Single Inspection Program

Canada has recently announced a new national approach to food safety inspection. The new program would include all food commodities made in Canada or imported.

Currently Canada has a 8-tier food safety program operated by Canada’s Food Inspection Agency (CFIA). The existing programs separately regulate meat, dairy, eggs, processed products, imported and manufactured food, fresh fruits and vegetables, and fish and seafood.

The new “single system” approach would combine each the different food sectors. According to Canadian officials, it would make the program even stronger and help with budget costs. It would also create a consistent inspection model, which will provide better training and tools to food safety inspectors, Agriculture Minister Gerry Ritz explained.

The CFIA is currently seeking public feedback (from both consumers and industry stakeholders) until October 31, 2012. The CFIA will finalize plans for the single system inspection program based on the feedback it receives.
 

E. coli Strain Decoded

Researchers at Michigan State University have recently decoded one of the deadliest strains of E. coli.

Scientists have identified the strain as O104:H4. The strain was responsible for the 2011 outbreak in Germany, which caused 54 deaths and sickened nearly 4,000 individuals. The strain was something scientists had never seen before. In addition to decoding the strain, researchers at MSU have also found a key aspect of the strain that could curtail the harmful bacteria.

O104:H4 shares common characteristics with other deadly E. coli strains. However, the property that makes this strain unique is a biofilm it forms. MSU researchers found when the strain forms a biofilm, it produces toxic genes similar to the Shiga toxins in O157:H7. The Shiga-like toxins were most likely the cause for the severity of the 2011 outbreak in Germany.

Another interesting point about the outbreak and the O104 strain is that it caused more kidney damage in adults. Normally Shiga toxins affect mostly children. Scientists attribute this to the longer incubation period that O104 has. This extended time allows for the biofilm to form, and also produce the toxic genes.

The next step is focusing on developing mutant strains to prevent the bacterium from forming biofilm. This would prevent disease and future O104:H4 infections, scientists say.
 

FSMA Regulation Stalls

After President Obama signed the new US Food Safety Modernization Act (FSMA) in January 2011, implementation of the new law has stalled. 

This week at the International Association for Food Protection Conference in Providence, Rhode Island, participants received disappointing news.  FDA spokesperson James Gorny told attendees that many of the FSMA implementing regulations have not yet been finalized.  He explained further that, despite the lack of progress, everything under the new FSMA remains in a “deliberative phase.”

The FDA has come under recent scrutiny for failing to implement many of the regulations called for in the new legislation prior to the deadlines established by Congress.  In turn, many of the implementing regulations, while finalized by FDA, remain under “review in the Office of Management and Budget (OMB). Gorny pointed out that continuing the delay may not be the OMB’s fault, though.  They are just responsible for the coordination of federal regulation.  Instead, he suggested, that at least some of the delay might be attributable to various issues with USDA and US Trade Representatives. 

In any event, time will tell how much more time it ultimately takes for the new regulations to obtain final approval.

Killer Copper

A recent study released by the University of Arizona found that utilizing copper cooking devices may significantly reduce the risk of foodborne pathogens.

The study compared how various Salmonella strains survived on copper surfaces versus stainless steel surfaces. The idea stemmed from the study’s co-author, Christopher Rensing, who had done previous research on antimicrobial properties of copper.

Copper has unique anti-microbial properties. Over time copper oxidizes and produces a residue that is toxic to some bacteria, including certain Salmonella and E. coli strains. Stainless steel, on the other hand, has no antimicrobial properties.

Professor of Microbiology at the University of Arizona, Sadhara Ravishankar, explained the group wanted “to see if copper could be used as an alternative to stainless steel in food preparation.” He also mentioned the study did not alter any cooking temperatures during the study to make sure they were testing only the influence of the metal.

Researchers tested multiple Salmonella strains on various concentrated-copper alloy samples. They found, in every situation, that the Salmonella strains died off in drastic numbers on copper, but were not as affected by stainless steel. They also conducted the same tests in various conditions including wet, dry, with and without nutrients conditions.

So what does all this mean? In short, if copper is used for cooking, it may potentially reduce the risks associated with harmful pathogens that cause foodborne illnesses.
 

Results Are In for Non-O157 STEC Tests

The federal Food Safety and Inspection Services (FSIS) published its results from the first round of testing for non-O157 E. coli strains this week. The agency began screening beef trim for the “Big Six” last month, and has tested 115 samples.

Overall, 4 out of the 115 samples were positive for non-O157 STEC strains. This yields about a 3% contamination rate. According to USDA, the test results showed no real surprises, and were consistent with industry testing. Currently, FSIS is testing only beef trim, not finished ground beef products.
 

Federal Egg Safety Rule

Effective earlier this week, the government has started enforcing the Egg Safety Rule for mid-size hatcheries.

The new rule is designed to prevent Salmonella contamination at hen laying facilities. In July 2010, the USDA enforced the same regulation on large facilities housing over 50,000 laying hens. Monday’s enforcement will affect mid-size companies that house between 3,000-50,000 hens. The regulation will not apply to small companies (under 3,000 hens) or facilities that sell directly to the consumer.

The regulation requires producers who do not pasteurize in-shell egg products to test for the Salmonella bacteria. Eggs also must be refrigerated at or below 45 degrees during storage (within 36 hours of laying). Chicks and young hens can only be sourced from facilities that test for bacteria. The facilities must also have biosecurity, rodent and pest control programs, according to the new regulation.

If Salmonella is found, affected eggs must be pasteurized or moved to a non-food use. In addition, the facility must be cleaned completely.

The FDA believes these “preventative measures would reduce the number of Salmonella infections from eggs by 60%.” According the CDC, approximately 2.2 million of the 65 billion eggs produced in the US each year are contaminated with Salmonella.

The FDA has done follow-up inspections with the larger facilities and found that most of them were in compliance with the rule. By the end of the year, the FDA hopes to perform the same inspections on mid-size facilities.
 

Hazelnut Food Safety Improves

Recent food safety concerns with hazelnuts were highlighted during a 2009 recall where nearly 30,000 pounds of nuts were recalled for potential Salmonella contamination.

There have been many smaller outbreaks since, including one involving E. coli in the Midwest. Notably, before 2009, there were no reported outbreaks linked to US hazelnuts. Currently, there is no industry safety requirement. Despite this, individuals in the industry have taken many steps to enhance food safety of hazelnuts.

For example, Willamette Hazelnut Growers comprises of nearly 99% of the hazelnut producers in the country. They investigated their own processing system after the 2009 recall, finding they needed improvements in the shelling their process. The company also decided to invest in a 3rd party microbiology lab to develop improved testing methodologies. As a result, the company now sanitizes all shelled products with an organic-water-based spray. The final products are then tested for bacteria. The company also tests the facility for contamination. So far, all the tests have come back negative.

Various groups in the industry continue to make efforts to ensure food safety. Growers have implemented a set of science-based guidelines know as GAPS (good agricultural practices). Handlers have also upped their standards by adding new steps that will reduce bacterial levels and noting the efficacy of them. Polly Owen, Manager of the Hazelnut Marketing Board, stated that industry is, “continuing to aggressively pursue the best practices possible.”
 

Au Revoir Foie Gras

As of July 1, 2012, California has begun enforcing a ban on the French delicacy known as foie gras.

Chefs and restaurants were unsuccessful persuading the California Legislature to withdraw the ban. California restaurants could face fines up to $1,000.00 if they violate the new restrictions. The implementation comes from a 2004 bird feeding law. However, the 8 year delay of enforcement was reportedly “to let producers adjust.” The law restricts both production and sale of foie gras and by-products like jackets and comforters made from down.

The French delicacy is made from fatty geese or duck liver. The process of producing foie gras was seen as cruelty towards animals. During the process, the birds are force-fed cornmeal to increase the size of their livers. Former California Senator John Burton, sponsor of the 2004 bill, said it has “nothing to do with meat. It has to with animal cruelty.”

Food safety was also was called into concern with the popular dish. Some argued that the force-fed birds could develop a blood-borne bacteria that could cause pre-mature death. Yet, the USDA rejected the claim.

Many of those in the culinary industry are not backing down without a fight. Various California groups have asked the federal courts to strike down the ban on the basis of its impact on interstate commerce. The court has stuck down a few similar bans due to the same argument. Another issue that has arisen is the law’s ambiguity. It does not give any standards for weight, volume, or caloric values.

The controversy over the popular food product continues nationwide. Notably, Chicago recently over-turned their ban on foie gras.
 

Knocking Out Salmonella in Denmark

This last year, Denmark has experienced some of the lowest reported Salmonella cases in any developed country.

Denmark set a personal best in 2011, with the lowest rate since the 1980s. After a spike of cases in the 1990s, the government decided to implore some of the toughest control measures to combat the issue.

For example, in environmental testing of chickens, if one bird tests positive for Salmonella, the whole flock is considered to be contaminated. Denmark also bans selling of fresh-eggs from any Salmonella-positive-laying flock. The country also requires all imported eggs to be completely Salmonella free. Notably, not a single case of Salmonella reported in 2011 was caused from chicken. Moreover, no Salmonella outbreaks (cases involving 2 or more illnesses) were traced back any Danish meat. Rather, the few Salmonella cases (non-outbreaks) were linked back to both Danish and imported pork.

In 2011, there were less than 300 cases of Salmonella Enteritidis (SE) in the country. In turn, approximately 70% of the reported cases were from citizens actually eating outside of the country. Danish authorities could not link the food source in about 25% of the cases. Those sources were most likely from food sources not regularly checked for Salmonella (i.e. fruits and vegetables).
 

Decline in the MRSA Superbug

A recent study conducted by the US Department of Defense found that the number of infections caused by the superbug, MRSA, are on the decline in both community and hospital settings.

MRSA, Staphylococcus aureus, is a type of staph bacteria that is resistant to many antibiotics. MRSA causes skin infection mostly. However, infections can become life-threatening, if it spreads to blood. The bacteria is transmitted through direct contact or touching of contaminated surfaces. It can also spread through sharing of personal items like razors, utensils, and towels.

The study assessed both hospital and community settings. Researchers reviewed data from over 9 million active and non-active military personnel and their families. The researchers broke the data down into 2 categories: skin infections and more serious case types. Notably, skin infections peaked in 2006 and then decreased steadily through 2010. Along with skin infections, more serious cases like blood-borne infection also decreased. The research also showed that individuals over 65, especially men, were more likely to contract the bacteria.

While the data shows a decline, the cause of the decline is still unknown. Dr. Kenneth Bromberg, director of Vaccine Research Center at the Brooklyn Hospital Centers, said, “It would be nice to be able to attribute this to better infection-control practices, but staph outbreaks come and go for reasons we don’t understand. The decrease in the rate of infections caused by MRSA may just be the way things go.” Others like Donna Armellino, Vice President of Infection Prevention at North Shore Hospital in Manhasset, NY, believe that the reduction can be explained for objective reasons. In particular, Armellino stated that the implementation of infection-control has gotten better over the years due to heightened awareness.

To prevent MRSA, it is advised to wipe down shared surfaces often and then letting them dry completely before touching them. In addition frequent and thorough hand-washing and avoiding sharing of personal items will also reduce risk.
 

USDA Increases Drug & Residue Testing

The USDA’s Food Safety and Inspection Service (FSIS) will be launching an updated testing program for meat, poultry, and eggs.

According to reports, the new system will allow agency to test for more drugs, pesticides, and potentially harmful chemicals at one time – versus individually. The Secretary of Food Safety, Dr. Elisabeth Hagen, stated that “the new testing methods being announced will help protect consumer from illegal drug residues in meat products.” She stated further that “testing for more compounds will allow USDA to identify and evaluate illegal drug residues more effectively and efficiently.” The new method will be able to test for 55 pesticide chemicals, 9 types of antibiotics, various metals, and over 50 other chemicals.

In turn, the data from the enhanced testing will be collected, analyzed, and published by the National Residue Program (NRP). NRP looks for both legal and illegal compounds. Examples include pesticides, environmental contaminants, veterinary drugs, and hormones. FSIS also claims that the new method will be “more efficient and conserve resources, while also providing better results.”

The FSIS will also be expanding its annual samples of slaughtered animals. If a sample turns out positive for residue, the supplier will be notified by the FDA and they could be subject to further testing.
 

WTO Rules Against COOL

On Friday, June 29, 2012, the Appellate Body of the World Trade Organization (WTO) ruled against the US’s country-of-origin labeling (COOL) law.

Reportetly, the WTO stated that the law discriminated against meat importers, specifically the US’s neighbors, Canada and Mexico. However, the WTO did agree the US consumer should have the right to know about the origin of their food. Therefore, the ruling included a requirement that the US amend its labeling law to ensure it no longer poses “a technical barrier to trade.”

This ruling stems from the 2009 implementation of the US law. In response to this action, Canada and Mexico filed independent appeals with the WTO, citing technical barriers and unfair trade measures. Canada and Mexico are the two biggest importers of meat to the US.

In its decision, the WTO stated that the COOL labeling laws give U.S. domestic beef, pork, and chicken an unfair advantage over imported competitors. In turn, the Canadian Cattleman’s Association said the law cost the beef industry $400 million a year, and the pork industry over a $1 billion. A Reuter’s study found that Mexican cattle are valued at $95 lower than US raised cattle.

After Friday’s ruling, both the US and Canada had positive statements about the decision. Ron Kirk, a US Trade Representative said that the “[decision] affirmed the US’s right to adopt labeling requirements ... [and] confirms that families can still receive information on the origin of their meat and food products.” The Canadian Cattlemen’s Associate stated that “upholding the part of the panel that confirmed the discriminatory nature of COOL, the Appellate Body’s final decision has provided an important victory for Canadian Cattle producers.” We wait to see whether, and to what extent, the U.S. labeling laws will be amended.
 

The Glove Debate Continues

In many jurisdictions, food preparation workers are required to wear gloves to better protect against contamination and keep food safety quality in-check.

However, there has been recent buzz on how safe those gloves really are. Many argue the gloves are only effective when worn by clean hands. They further argue that gloves give employees a false sense of security and become automatic and ubiquitous. The purpose of the gloves is to protect against disease transfer to consumer like Hepatitis A, norovirus, E. coli, and other foodborne illnesses.

In studies conducted by the Journal of Food Protection in both 2007 and 2010, results concluded that gloves may not be as effective as once thought. The 2007 study found that “hand washing and glove use were related to each other…hand washing was less likely to occur with activities in which gloves were worn.” The 2010 study produced similar findings, noting that “glove use can create a false sense of security, resulting in more high-risk behavior.” The study also found the occlusion of the skin can create the prefect breeding ground for “microbial proliferation” and can “increase pathogen transfer onto foods.” Interestingly, they also found twice as much coliform bacterium on tortilla samples handled by gloves versus bare hands.

Another issue that has risen is the cost of using disposable gloves. Some argue that those resources could be spent alternatively to invest in kitchen improvements like automatic or food-pedal operated sinks to give works adequate time to wash hands properly.

However, the problem isn’t the gloves, but what workers do while wearing the gloves. Some of those actions can contaminate gloves, which in turn can contaminate food. In 2006 and 2007, studies conducted by the Center for Disease Control found hand-washing requirements by employees wearing gloves were not being adequately met. Those workers in the study only washed their hands in 27% of the activities that recommended hand-washing.

Denise Korniewicz, Dean of Nursing at the University of South Dakota explains, “the best way to prevent transmission of bacteria, virus, or other bugs is to wash hands thoroughly.” In correlation, the CDC recommends decreasing the amount of times a worker is put into a scenario where he or she has to wash his or her hands. This means revising food preparation methods and decreasing handling of raw material like meat and fish. The food service industry still relies on the glove-method. It is necessary in sectors like in raw meat and fish preparation. The gloves do help avoid cross-contamination, if used properly.

No one product will keep food safe. However, regular and thorough handwashing, along with a conscious use of gloves will keep food safety risks down.
 

Scotland's Food Safety Independence

The Scottish government has recently decided to break away from the United Kingdom’s Food Standards Agency (FSA). Instead, they will be setting up their own food standards agency. The new agency will be responsible for food safety, food standards, nutrition, food labeling, and meat inspections.

This action stems from the 2010 decision by UK’s government to move food labeling and standards from the FSA to the UK’s Department of Health of Environment, Food, and Rural Affairs. After this decision, Scotland decided to conduct research to decide what the best option was. The research panel published their report in April, advising that Scotland should go “independent.” Scotland’s Health Minister, Michael Matheson stated, “the changes in England removed significant capacity in the FSA’s nutrition and labeling functions for Scotland and needed to be address.”

The new agency will allow Scotland to tackle in-house emerging diet and foodborne illness issues. In addition, the move will help Scottland ensure that the food and drink industry of Scotland will continue to have a strong reputation for safety and quality.
 

Heat Takes Toll on Meat Industry

The recent heat wave will be affecting the meat industry both short and long term, analysts say.

And, some part of industry will be affected more than others. Cattle ranchers will see more short term detriment, whereas meat processors will see a long term affect. The factors creating these issues are numerous.

Some animals handle heat better than others. Hogs are easily stressed by heat, whereas cattle are not. However, the cattle are affected in other ways, reflected in their environment. Pastures have been ruined due to the extreme temperatures. Professor Ron Plain at University of Missouri Department of Agricultural Economics explains that, when grass doesn’t grow, cattle are moved to feedlots more quickly. The responsibility of feeding the cattle falls on the feedlot. But, here too, there is a squeeze. This is because the sustained heat is also affecting the corn crop, which is is a major ingredient in cattle feed.

Indeed, the dry conditions have led to a poor yield of corn this year. Less corn, of course, translates into greater cost. Boosting the cost of the corn then boosts the cost of raising cattle. This in short term affects the cattle ranchers and feedlots who have to pay a higher price for feed.

“It doesn’t affect beef packers, except in long term, because this is going to slow down their prospects this year,” Jim Robb, Director of Livestock Marketing Information Center states. “There had been a slight probability of a small increase in beef supply before this hot weather hit,” this takes away from that Robb explains. He continued that packers are going to see and increased decline in herds and suppliers.

These factors add further insult to injury, as there is already a short cattle supply. As of April, beef packers began losing money when demand for lean textured beef declined. The continued heat and, and its effects on the overall cattle supply, will continue to be a strain on the meat industry.
 

Scientists Link Tick Bites to Red Meat Allergies

Scientist Thomas Platt-Mills has linked lone star tick bites to red meat allergies. The findings came about while studying a particular cancer drug. Patients taking the drug had severe allergic reactions. However, this phenomenon was only occurring in Southern States. Platt-Mills and his scientists concluded in their 2008 study that it was a sugar in the drug, derived from mouse cells that are found in beef, pork, and cow milk, causing the reactions.

At the same time of this research, there was also an influx of meat allergy reports in the South. Out of curiosity, the scientists took their own blood samples and found that they carried the same Immunoglobin E (IgE) antibodies as the cancer patients who reacted to the drug. Thus, concluding that it was the sugars triggering the response.

However, because people were complaining of symptoms of the meat allergy 3-5 hours after consumptions, scientists noted that the source must be coming from sugar stored in animal fat, which takes longer to digest.

The next question was where were the antibodies coming from? Initially, Dr. Scott Commins, Assistant Professor of Medicine at UVA and colleague of Platts-Mills, thought it must be a parasite.

However, in 2009, Platt-Mills made a break through discovery after taking a walk in the woods. He noticed his IgE levels spiked after those walks where he incurred tick bites. After this discovery, they started asking patients experiencing this rare meat allergy if they had tick bites.

They found 90% of those experiencing the allergy, had been bitten by the long star tick. Not only are cases showing in the South, but the East Coast is also being affected. Now scientists are exploring why this particular tick is related to the phenomena? Their hypotheses include: a new organism in the tick’s salvia or that ticks have always carried this antigen, however because there are now an increase of ticks, the meat allergy is more detectable.

Warning signs include a lingering bite, itchiness, and/or a forming of a hard knot under the bitten area. Commins states, there is not much for prevention. However, if inflicted with allergy, it only lasts for 3-5 years. The downfall is that if bitten again, the allergy could become worse.

So far, governmental agencies have not yet issued any health warnings about meat allergies associated with the lone star tick….
 

Shigella Outbreak in New York

Health officials announced that they were investigating a Shigella outbreak in Onondaga County in New York. To date, there have been 21 confirmed cases.

Reportedly, half of those inflicted with the illness are under the age of 10 years old.

Investigators are currently trying to determine source of the bacteria. They think it is being transferred by both food and person-to-person contact.

Shigella is easily transmitted from person-to-person. There are anywhere from 20,000 to 40,000 reported cases a year. Symptoms appear 1 to 3 days after exposure. They can include stomach cramps, fever and diarrhea (which can contain blood or mucus). The illness normally lasts 5 to 7 days.

The Onondaga County Health Department meanwhile is advising area residents to take precautions. These measures include washing fruit and vegetables; cooking food to the appropriate temperature; avoiding cross-contamination; washing hands often and thoroughly; disposing of soiled diapers properly; and keeping children with diarrhea out of social settings.
 

Possible New Salmonella Vaccine

Scientists from the University of Maryland have developed a new possible salmonella vaccine using salt. The salt forms around a microbe (Haloarchaea) that has been genetically altered to act as a vaccine for Salmonella. More specifically, the Haloarchaea acts as a delivery device that promotes the same responses to vaccines as the immune system does. Salmonella protein antigens are spliced into Haloarchaea genome, which causes a reaction that bubbles into salt crystals, which people can digest.

If proven safe and effective the vaccine would be victory in a multitude of ways. Not only would it help decrease the number of illnesses, it could also help one solve one of the biggest vaccine-distribution related issues: refrigeration. Interestingly because the vaccine is salt-based, it would not require refrigeration like most other vaccines. In addition, the vaccine is also inexpensive and easy to store. DesSarma points out it is also very safe because it doesn’t cause any disease itself.

Researchers still need to test vaccine to find out what the proper dosage should be. The vaccine will most likely will be available in pill form. Scientists feel this is a great platform for innovating other vaccines for infectious diseases. The research received a $100,000 grants from the Bill and Melinda Gates Research Foundation.

China Announces New Food Safety Program

China has recently announced a new 5-year food safety program to address continuing concerns about its food industry.

According to reports, the government will be updating, reviewing and eliminating any old and overlapping regulations and standards. Many standards and regulations currently contradict one another. This is a result of multiple government agencies regulating the industry. There will be 14 different government departments including the Ministry of Health, Ministry of Science and Technology, and Ministry of Agriculture, that will work together to revamp regulations and standards by 2015.

The government will prioritize safety standards for dairy products, infant food, meat, alcohol, vegetable oil, seasoning, health products, and food additives. They will also take extra steps to improve testing standards for contaminants, food additives, microorganisms, pesticides and animal drug residue.

The new program comes after nationwide concern about food safety in China. Indeed, suspect food from China has been involved in many recent food safety headlines. Scandals have included mercury findings in baby formula, produced by one of the biggest dairy companies in China; clenbuterol involving pork; and overall concerns about Chinese food products.

Reportedly, the plan will add 269 new national food standards and require more supervision and harsher consequences for violators. The Chinese government released a statement acknowledging the difficulty of the task; however, overall, they are hoping to simplify the complex and confusing system. Time will tell whether they get it right.
 

US Senate Passes New Farm Bill

The previous Farm Bill was set to expire in September of this year, this week the Senate passed the new Farm Bill 2012.

The new bill has come under scrutiny. While some feel the bill is a step in the right direction, others feel it sends the wrong message.

This month a letter was submitted by the Environmental Work Group (EWG) expressing concerns about the content of the bill. The overall consensus was that while the USDA is encouraging healthier foods, the Senate is seeking to invest money into more processed types of food instead. The Farm Bill assigns most of its funding to commodity crops (such as corn, rice, soybeans, and wheat), which of course are basic ingredients for processed food. Kari Hamerschlog, Senior Food and Agriculture Analyst for EGW, explains the point of the letter was to “urge Congress to stand up for healthy food and farm bill.” Hamersclog also expresses concerns that the bill is not addressing food and farming challenges or what the American public expects from the food and farming industry. She points out a national poll conducted in July 2011 found that 78% of respondents said, “making nutritious and healthy foods more affordable and accessible should be top priority in the farm bill.”

Hamerschlag stated further that fruit and vegetable growers are vital for “improving America’s nutrition and reducing the costly toll of diet-related diseases.” Failure to invest in healthy foods such as these, she argued, could potentially lead to increased health-care costs, and decrease accessibility due to affordability.

However many support the new Farm Bill. United Fresh Produce Association (UFPA) gave Senate approval and encouraged them to pass it as soon as possible. Food Safety experts feel that it the bill will have a positive effect on food safety. Supporters of the bill feel that no bill will ever be perfect, but this bill provides steps in the right direction. Many of the measures in the bill give farmers a safety net that they might not have otherwise.

The legislation was passed with 64 votes on June 21, 2012. The bill will cost $500 billion over a 5-year span, and will now go on to House of Representatives for final approval.
 

Removal of South Korean Seafood

Due to possible contamination from reported human waste and norovirus, the FDA is advising food distributors, retailers, and vendors to remove all shellfish imported from South Korea.

The decision comes after the FDA evaluated the Korean Shellfish Sanitation program as not meeting adequate sanitation controls. The FDA recently removed the country from the certified shellfish shippers list.

The warning includes fresh, canned, and processed seafood imported from South Korea prior to May 1, 2012. The order specifically targets oysters, clams, mussels, and scallops from the country. The problem stems from polluted fishing waters. However, the FDA is working with South Korean authorities to fix the problem.

Although some food companies have taken precaution and already removed suspect products, the FDA is urging all companies to do so. The FDA is also advising consumers to check labels and contact vendors if they have any concerns. In addition, they recommend throwing away suspect seafood products from South Korea to avoid possible illness.
 

Indiana's Raw Milk "Virtual Public Hearing"

The Indiana General Assembly has appointed the Indiana State Board of Animal Health (BOAH) to study the topic of raw milk. BOAH will be conducting a 3 month long “Virtual Public Hearing” from June 1 to September 1 to gather information. They will then produce a report by December 1(if not sooner) with the gathered information. Indiana is the first state to conduct a compressive study of raw milk since the 2010 raw milk report. The 2010 report helped develop regulations to ensure safety of raw milk.

Currently, Indiana law bans the sale of raw milk. However, farm families locally are permitted to consume raw milk from their farms. Indiana is one of20 states that bans the sale of raw milk entirely. However, 30 states allow non-pasteurized sales in some fashion.

BOAH feels their overall task will be to decide whether or not the sale of raw milk should be permitted in any form. They are hoping for a strong turnout with the virtual hearing. Terry Philibeck, BOAH’s dairy division manager, explains, “we wanted to find a way for every Hoosier to participate.” The virtual hearing allows citizens to participate around their schedules.

To participate in Indiana’s raw milk virtual public hearing, click on the following link: www.boah.in.gov. For those who do not have internet access, you can submit commits via US Mail to: BOAH Attn: Raw Milk comments, Discovery Hall, Suite 100, 1202 E 38th St., Indianapolis, IN 46205.
 

Parasite Risk In Some Organic Meat?

Is organic more safe?

New research published in the Journal Clinical Infectious Diseases has shown that a certain parasite known as Toxoplasmosis gondii is more likely to be found in organic as opposed to other types of meat.

The study’s author, Dr. Jeffrey Jones claims that the increasing “demand for ‘free-range’ and ‘organically raised meats’ (especially pork and poultry) will likely increase the prevalence of the parasite, especially when people undercook and eat these foods.” This foodborne illness is transmitted if meat is not cooked properly. One can also contract Toxoplasmosis by not washing raw fruits and veggies that have been in contaminated soil.

About 1 in 5 people carry the parasite. However, because our immune systems do such a good job of fighting the parasite, many do not show symptoms. Symptoms of the parasite are similar to those of the flu. In rare cases, if the parasite progresses, it can cause damage to the brain, eyes, and other organs. Most at risk are pregnant women and those with weakened immune systems.

The new research reviews foods that are more likely to carry these types of parasites that are naturally found in the environment. These foods include rare lamb; raw ground beef; unpasteurized goat’s milk; locally cured, dried, smoked meat; and raw oysters, clams, and mussels.

Research has shown an increase of anywhere from 17%-100% of parasites in free-ranged chickens versus indoor-raised chickens. Other research has shown organically raised pigs have tested positive more frequently for the t. gondii parasite than conventionally raised pigs. The problem occurs because pigs and chickens are being raised in less contained areas. Therefore they have a wider-range of area to roam and thus be exposed to contaminated soil, grass, water.

Toxoplasmosis is 1 of the 5 “neglected parasitic diseases” targeted by the CDC as a public health priority. Recently, a US estimate showed toxoplasmosis was the 2nd-leading cause of foodborne illness next to Salmonella, causing over 300 deaths and thousands of hospitalizations a year.
 

Multiple State E. coli O145 Outbreak

Federal Officers have confirmed as many as 14 cases of E. coli O145 in 6 different states. In total, 3 have been hospitalized and 1 person has reportedly died. The affected states include Louisiana, Georgia, Alabama, Florida, California, and one other state that the CDC has not yet released. The onset range of reported illness is currently believed to range from April 15 to May 12.

Georgia has seen the largest number of cases. They have had 5 cases involving females ranging in age from 18 to 52, with an onset range between April 15 and April 28. The Georgia Department of Health has reported that the cases have been mild. The head of the Division of Health Protection at the Georgia Department of Public Health, Dr. Patrick O’Neal confirmed further that, “I don’t think there’s a need for great concern. I think awareness yes, concern no” addressing the nature of the outbreak.

The most common strain of E. coli is O157. The CDC says the non-O157 serogroup is less likely to cause severe illnesses (like the O157 strain). Nevertheless, in rare cases, some strains in the serogroup can cause STEC illnesses similar the O157 strain.

The cause of this outbreak is still unknown, and an investigation is currently underway. Infectious disease investigators have to conduct interviews with the victims to see what they have in common to find the cause. Because E. coli has an incubation period spanning multiple days, investigators rely heavily on people remembering accurately what they consumed or came in contact with.

Meat, poultry, fruit, and veggies are the main culprits of E. coli. However, other ways to contract the virus can be from contact with cattle or feces of an infected individual. The young and elderly are more at risk to serious illness or death with E. coli due to weaker immune systems. Washing hands and utensils with warm soapy water, avoiding cross-contamination in food preparation, and most importantly cooking meat thoroughly (above 160˚F) are the best ways to avoid E. coli altogether.
 

Crypto Outbreak in Great Britain

Britain’s Health Protection Agency (HPA) has reported an increase of cryptosporidium outbreaks throughout England. The areas include North East, Yorkshire, West Midland, and East Midland, affecting mainly adult women. Infected individuals have shown moderate illness. Only a few have been hospitalized.

With warmer weather it is common for an increase of crypto numbers, however this year stands out.

There are over 250 reported cases, which is a significant increase to the nearly 70 reports last year. The HPA is currently investigating to see if there is a connection between the outbreak areas.

HPA has teamed up with the National Health Services (NRS), the Food Standard Agency (FSA), local health officers, drinking water inspectorates, and area doctors to further the investigation.

So far they have not pinned-point a single source. However, based on the distribution, they have eliminated public water supplies as a possible cause.

Cryptosporidium is a parasite found in soil, food, water, or surfaces contaminated with infected feces. The most common way of infection is swallowing water while swimming. There is no specific treatment for the infection. Symptoms can include dehydration, stomach pains, fever, weight loss, and diarrhea. Symptoms can last for up to three weeks. However, most people fully recover within a month. It is important to drink a lot of fluid if infected to avoid dehydration. For now, Great Britain has advised its citizens to avoid untreated water sources and avoid swallowing water while swimming.
 

Study Finds Contamination in Wisconsin Water Systems

A study by the Marshfield Clinic Research Foundation concluded that untreated water systems can in some instances carry human viruses in drinking water.

The study found that water that was not disinfected in 14 communities tested positive for human viruses. in turn, the study concluded that people who live in communities with untreated water are likely being exposed to waterborne illnesses and other harmful health risks. This is one of the first studies to link viruses in public water supplies to effects on human health. Click on the following to view the Marshfield Clinic Research Foundation Study.

One virus commonly found during the study was norovirus. Norovirus is one of the most contagious viruses that can spread person-to-person. Notably, the study also blamed the virus for nearly 2/3 of the illnesses in children under the age of 5 years old.

The study linked the source of the contamination to leaking wastewater from sewers. The wastewater contained human waste viruses that traveled through the soil and into the groundwater. The groundwater was then used as a source of drinking water in the affected communities. Notably, groundwater is the most common way communities receive their drinking water.

The study was initiated after the Wisconsin Department of Natural Resources (DNR) proposed regulations to require all communities to disinfect their systems. This regulation never passed and became a heated topic. Some felt that it should be up the individual community to decide whether they should disinfect their water systems, while others felt there should be a statewide mandate based on the federal Safe Drinking Water Act.

In total 66 Wisconsin communities do not disinfect their water systems. The study’s findings were 4,500 times higher than the EPA’s acceptable risk. The DNR still recommends disinfecting water supplies, despite the rejected regulations. The EPA announced, however, that they will require monitoring of these communities between 2013 and 2015.
 

Food Safety Incidents Rise in United Kingdom

For the second year in a row, food safety incidents have been on the rise in the United Kingdom. The Food Standards Agency’s (FSA) executive director, Tim J. Smith, reasons it is not because of one particular reason. Instead, he and the organization attribute, “a combination of factors, including better reporting, and monitoring are behind the trend.”

Incidents are reported through various outlets: border inspection posts, health authorities, and fire services” Incidents generally describe contaminated food or illegal food that has gotten into the hand of the public and caused harm, and also includes allergens, pesticides, and microbiological contamination. FSA also reports they have seen an increase of food borne illness reports linking to foods abroad (specifically from China, India, and Bangladesh).

This year, the UK has another hurdle to jump: hosting the 2012 Summer Olympic Games.

The FSA has already taken steps to ensure proper food safety measures are in place and being enforced. They have added a new online incident reporting system. This will allow local authorities, along with food vendors report and intervene in any incidents in a timely manner. The United Kingdom reportedly has some of the most progressive food safety measures. When an incident occurs, they are very proactive in working with other agencies to rectify the problem.
 

8-Year Salmonella Outbreak Tied To Hatchery

The New England Journal of Medicine has published an article about how investigators were able to solve the 8-year long mystery of a Salmonella outbreak.

The source: mail-order chicks.

This was reportedly the longest outbreak of a single strain of Salmonella in US history. Between 2004 and 2011, there were over 300 reports covering 48 different states all consisting of the same strain. In addition, there were thousands of unreported related illnesses. Investigators were able to link the outbreak to chick hatcheries based on patient interviews, disease surveillance, and trace-back methods.

The first big lead was in 2005, with the Colorado Department of Health. They were able to identify three salmonella types with the same genetic make-up. They found those individuals affected by these strains had one commonality: contact with ducklings at feed stores. From this information, they found that all the cases nationwide shared the same underlying facts.

The next break occurred in 2006 in New Mexico, which had the largest number of reported cases. Officials reportedly focused their research on local stores that sold young chickens. They used a series of questions to then trace where the retail stores obtained their live animals. Investigators ultimately determined that the contaminated chicks had been coming from 7 different hatcheries.

The article states further that one of the hatcheries, “Hatchery C” took many preventative measures to ensure safety of their animals. Although the hatchery had increased biosecurity and rodent control, food decontamination processes, routine surveillance, and used an autogenous poultry vaccine, “a temporary lapse in the hatchery’s procedure in 2010” Was believed to have caused the contamination. Investigators also found that “Hatchery C” had what is known as a closed breeding facility (no outside flocks of birds breed in the facility) which helped explain how the same strain of bacteria could have persisted in the flock for 8 years.

Notably, only one human case has been reported this year involving the same strain of Salmonella. The author of the paper writes, “the outbreak showed that control intervention at mail-order hatcheries can play a role in reducing salmonella, but also showed the difficulty of executing procedures,” emphasizing the important role hatcheries have in outbreak prevention.
 

Don't Call It "Corn Sugar"

The FDA has denied a petition to permit food processors to rename high fructose corn syrup (HFCS) as “corn sugar.” The petition, pending since 2010, was filed by the Washington DC Corn Refiners Association (CRA). Since filing the petition, the CRA has also been spearheading a national campaign to promote the new name.

The CRA and supporters of the name change claim the FDA was too quick to make decision. They claim that the FDA ignored scientific evidence that HFCS is, indeed, a form of sugar and thus has the same basic nutritional make-up of sugar. Therefore, CRA has argued, HFCS is “sugar.” The CRA has also asserted that HFCS is an already confusing name for consumers, leading them to think that the product is worse than sugar.

FDA’s Director of the Center for Food Safety and Applied Nutrition, Michael M. Landa argued against the name change. He felt calling HFCS “sugar” would not be an accurate way of identifying, describing, or characterizing the product. Landa also argued that consumer confusion could be increased given existing FDA regulations. He used the example of categorizing of “dextrose” as “corn syrup.” The FDA would then have to change “dextrose” to “corn sugar” which could confuse consumers, especially those who have health problems associated with dextrose. Landa also highlighted the implications of a name change for those individuals who may be stricken with fructose intolerance. He felt by renaming “corn syrup” to “corn sugar,” those individuals may be lead to the assumption that it is ok to consume products with corn sugar. Overall, Landa’s arguments focused on the agency’s interest in protecting consumers health by protecting them from additional confusion.

Ultimately, the FDA stated that their ruling is consistent with basic understanding held by consumers of sugar and syrup. Notwithstanding the FDA’s decision, the CRA plans to continue its efforts in pushing for the name change.
 

Food Safety Industry Booms

The demand for new and improved food safety products in the US market has bolstered in the recent years. Industry experts feel this substantial growth will continue through 2016. Factors such as consumer interest, awareness, new government regulations, and industry initiatives all contribute to the increased demand. Various parts the food industry including the processors, servicers, and farmers markets are all taking note.

Among one of the fastest growing products in food safety are smart labels. A smart label is a flat responsive electronic device that can perform and track various functions. These labels help with the traceability of food supply. They can also play a crucial role in a outbreak by linking the contaminated food back to its origin. Along with smart labels, diagnostic products are also expanding. However, these products are more expensive. Diagnostic products test food for a multitude of food safety related factors.

Representing the largest market for food safety products is in the processing plants. In this market, there are many fast growing areas such as seafood, prepared food, and beverage segments that receive significant regulation. In turn, companies in these segments are looking for new ways to reduce both their regulatory burden and food safety risks.

Food service also accounts for a significant part of the food industry. Growth in the service area has been accelerated over the recent years due to increased profits. Here too, larger profits have allowed the food service industry to develop and purchase a greater range of food safety-oriented products and services. Additionally, product demand in this industry has also risen due to efforts in improving sanitation and avoiding cross-contamination.

Looking forward, it is anticipated that, at least through 2016, farmer’s markets will be one of the fastest growing sectors for food safety products. Industry experts feel this is because, “crop and product uses will outpace those of livestock due to increased pathogen testing of produce at the farm level and continued presence of GMOs at the grain levels.” In other words, the production of produce will likely outrun meat production due the vast regulation of pathogens. With the popular trend of growing and buying local, more regulations are being adopted and enforced at these levels as well.

This projected expansion of food safety products in the United States is forecast to continue through 2016. Based on increased efforts to decrease the possibility of foodborne illnesses and increased consumer awareness, new products will continue to be marketed. Hopefully these efforts will help ensure that the US food supply remains one of the most affordable and safest in the world.

USDA Will Soon Begin Testing For Non-O157 STECs

The USDA will soon begin testing for six additional strains (the “Big Six”) of E. coli that they have not previously tested in meat processing facilities. This is a result from extensive research on different outbreaks involving the strains in the past few years.

The “Big Six” have been traced to outbreaks and illnesses in the recent years throughout the country. Most frequently in cases linked to sprouts and lettuce. In 2010, for the first time, the “Big Six” strains reportedly caused more illnesses combined than the O157:H7 strain. Patricia Griffin, senior scientist at Center for Disease Control and Prevention, estimated that the six strains were responsible for “70% of the country’s illnesses linked to E. coli."

The meat industry is raising concern about the new law. They feel they are being targeted unjustly, based on several arguments. One that the presence of E. coli does not mean it will cause illness. Most strains of E. coli are harmless, only some produce toxins that sicken people like the O157: H7 strain. Also, the American Meat Institute points out the recent outbreaks related to the “Big Six” do not even involve beef. In addition, the industry is also worried about the amount of time that testing will require. In particular, many companies are expressing concern that the amount of time it takes to receive results will shorten the meat’s shelf-life.

With that said, however, the need for substantial additional testing may never fully materialize. This is because FSIS may ultimately allow existing testing to serve as an equivalent for the Big Six. In essence, to the extent existing tests which are being used to control for O157:H7 will also presumptively indicate the possible presence of non-O157 STECs, these tests may ultimately be deemed sufficient for non-O157 STECs as well. Debate on this issue is continuing.

Elisabeth Hagen, USDA’s undersecretary of Food Safety explains, “What we’re doing is about prevention.” The USDA has been taking greater steps in preventing food borne illness in the recent years. This past September, officials felt that they could classify the “Big Six” as “adulterants” or contaminates.

This classification, of course, requires the government to begin testing for them. What remains to be seen is how the new rules and testing requirements, if any, will be enforced on industry.
 

Grow Green Launches Groundbreaking Food Safety Solutions

Grow Green Industries Inc. and P.L. Thomas & Co. Inc. just announced they will be launching two new all-natural food safety and shelf-life enhancer products at the Food Technologists Annual Meeting and Food Expo in Las Vegas in June. The products are eatSafe™ Natural Food Wash and eatFresh™ Natural Antimicrobial. According to the company,they will be a two-part alternative to longer-lasting, better tasting, and safer food.

The products use synergistic complexes of FDA-approved GRAS (Generally Recognized as Safe) and organic components used in food processing to make sure products do not carry foodborne bacteria. Both will come in a liquid or powder form. They will protect against pathogens, extend the shelf-life, and make the food product overall safer to eat. eatSafe™ also removes other contaminants like oils, dust, and pesticides. In addition, unlike its competitors, eatFresh™ is a near taste-less replacements for preservatives: allowing no impact to the overall flavor of the food.
Reportedly, both products control pathogens by a cell electro-potential disruption mechanism. As a result, they have a large range of ability to handle various levels of pathogens. This avoids having to combine certain preservatives that could be expensive and alter the taste of the products.

The patent-pending products have been put through a series of lab tests both by the manufacturers and third-party lab testers. Results from the studies showed that eatSafe™ Natural Food Wash “removed 99.999% of bacteria, including Salmonella, E. coli, Listeria and coliform bacteria from the surface of produce.” Other studies have found eatFresh™ Natural Antimicrobial has extended the shelf-life of food by 200% compared to other test controls.

Both companies are very excited and proud of the new product line. Founder and CEO of Grow Green, Mareya Ibrahim says, “[food safety] is a problem that is worth our attention. And we felt an all-natural solution that avoided potentially harmful chemicals was a natural extension of that drive.” President of P.L Thomas, Paul M. Flowerman, explains, “these new all-natural products open up new opportunities for consumer product development and can significantly reduce overall costs for all-natural foods and beverages.” Both admit that all-natural and clean labels are the new trend in the industry. However, they are hoping these products will, “offer an end-to-end solution for improving taste, quality and shelf life.”
 

Norovirus Finds Home In Reusable Grocery Bags

A recent study published by The Journal of Infectious Diseases has linked reusable grocery bags to the spread of foodborne illness, including norovirus.

The study found this was the cause of a 2010 outbreak that infected an Oregon girls’ soccer team traveling to Washington. In this situation, a reusable grocery bag containing snacks for the team was left in the bathroom of a hotel room where a sick team-member was staying overnight. During that night, the girl had gotten ill with vomiting and diarrhea. The next day the bag’s contents were eaten and handled by other members of the team. Within 48 hours individuals who had made contact with the bag or ate the content became ill with norovirus. The outbreak continued when the girls’ returned, their household members also became ill with the virus. The catch of this outbreak was that no-one had direct contact with the initially sick girl, just the reusable grocery bag. The initially sick girl claimed never to touch the bag or its contents.

“This is the first published report of norovirus infection without person-to-person transfer…and first-ever reported case transmitting norovirus with an inanimate objection,” commented, Kimberly Repp, a case study co-author and epidemiologist with Oregon’s Washington County Health and Human Services. Experts say the bag was contaminated by viral particles that had floated over to the reusable bag from the toilet in the sick girl’s bathroom. During the investigation, researchers swabbed the reusable grocery bag finding it contained the same strains of norovirus that infected the girls. Leading to the conclusion the culprit was the reusable bag. Researchers say this highlights how easily the virus can be transmitted and remain on surfaces.

Norovirus is one of the most infectious viruses in the world. It is responsible for about 21 million cases of gastroenteritis (stomach flu) a year, leaving tens of thousands hospitalized and hundreds dead. Transmission of norovirus can be attributed to particles of vomit and feces floating in the air that land on nearby surfaces.

The University of Arizona and Loma Linda University also did a combined study about bacteria and reusable grocery bag. They found there are significant amounts of bacteria on reusable grocery bags, including E. coli. Yet the study’s conclusion was washing the reusable grocery bags will decrease the contamination by 99.9%.

However as Dr. William Schaffner (chairman of the department of preventive medicine at Vanderbilt University Medical Center), states “risks of contracting an illness from a reusable grocery bag is low.” The virus can be eliminated from surfaces with using household cleaning products like Lysol or bleach.

The bottom line: use good hygiene (i.e. wash hands and surfaces thoroughly).

And, maybe, just maybe, use disposable grocery bags.
 

Pet Food Now In FDA Spotlight

At the urging of FDA, Diamond Pet Food has expanded their recent pet food recall.

The company has now been asked to include certain types of dry cat food, in addition to dog food. There is no detailed information on which brands of cat foods that could be impacted. The recall initially began in April on dry dog food. Since then the company has announced several different recalls on products manufactured between December 2011 and April 2012.

The pet food has allegedly been linked to numerous cases of salmonella in both animals and humans in the US and Canada. The federal government traced 14 cases of the salmonella back to the pet food this past month. In addition, a Canadian newspaper reported two cat deaths and one cat illness after the animals ate the food at a local shelter.

The FDA launched an investigation into Diamond Pet Food after the first recall last month.The agency allegedly  linked the problem to the company’s facility in Gaston, South Carolina.

The FDA's initial report found “all reasonable precautions are not taken to ensure that production procedures are not to contribute contamination from any source.” The FDA blames the screening process as the possible culprit.

The FDA also announced many alleged violations or varying degrees of seriousness, including handling equipment with bare hands, lack of hand-washing stations, and damaged equipment. Due to the open investigation, information available to the public is limited. This is a good example of how the FDA is becoming (and will likely continue to become) stricter on pet food companies.

Diamond Pet Food is moving forward after the recent recalls. They have kept their hotline open for consumers to ask questions. In addition, the company has voluntarily shut down their Gaston facility to clean and institute new safety procedures.

Recent FDA testing at the site found no contamination. In total 13 brands of Diamond Pet Food are affected (Chicken Soup for the Pet Lover's Soul, Country Value, Diamond, Diamond Naturals, Premium Edge, Professional, 4 Health, Taste of the Wild, Apex, Kirkland Signature/Kirkland's Signature Nature's Domain). Brands manufactured at the Gaston plant have issued separate recalls of the products produced: Natural Balance, Solid Gold, and Wellness.

The FDA investigative efforts and resulting recalls should serve as a wake up call to the pet food industry -- moving forward, we expect the FDA to begin focusing nearly as much attention on pet food as the agency has given other segments of the food industry.

E. Coli Outbreak Renews Raw Milk Fight in Oregon

After last month’s E. coli O157:H7 raw milk outbreak, the Oregon Dairy Farmers Association is continuing its fight for tighter restrictions on the sale of unpasteurized milk.

Unpasteurized milk was to blame for the April outbreak. The outbreak sickened nearly 20 people including two kids who allege possible long-term complications associated with kidney failure. Executive Director of the Oregon Dairy Farmers Association, Jim Krahn, claims this incident is an example of why stricter regulations are a necessity.

Pasteurization did not become mainstream until after World War II. The process involves heating the milk to kill harmful organisms. Harmful organisms can be responsible for diseases like listeria, typhoid fever, tuberculosis, and diphtheria. But, pasteurization does not necessarily kill all harmful bacteria.

Consumers of unpasteurized (“raw”) milk do not want to give it up. They feel that it provides many health benefits. They argue that it contains many good bacteria, enzymes, proteins, and vitamins, among other benefits essential for the body. Sharon Trayhorn, a mother and consumer of unpasteurized milk, claims her kids get “constipated, runny noses, stuff like that if I use store-bought milk.”

An Oregon State survey found that less than 3% of the total state population consumes unpasteurized milk. Some feel that a ban on unpasteurized milk could cause a black market for the product, like County Health Officer Dr. Gary Oxman believes. He feels the state already does a sufficient job of preventing “uninformed consumers from getting the product.” Oxman feels that those who want the product already have to go through great lengths to obtain the unpasteurized milk.

Contrary to Oxman’s beliefs, others like Dr. Barbara Mahan (co-author of a study for Centers for Disease Control and Prevention) feel that if there are no restrictions on raw milk there is a greater risk for outbreak. She stated that, “there are twice as many outbreaks in states that allow unpasteurized milk.” She feels that “when it’s legal, more people drink.” People tend to feel that if it is legal, it must be ok.

ODFA (Oregon Dairy Farmer’s Association) is planning to hold a meeting this summer to address this issue. They will be inviting legislators, dairy farmers, and state agricultural officials. However, they will be excluding consumers and producers of raw milk. They are hoping to continue the fight after decades of warning against the risks of unpasteurized milk.
 

Farmer's Market Growers Face New Liability Expense

The Greeley Colorado Farmer’s Market  has announced a new requirement for participants. Vendors will now be required to carry at least $600,000 worth of general liability and product liability insurance. In the past there were no requirements for insurance coverage.

The new requirement follows a listeria outbreak last year that killed as many as 30 people due to contaminated cantaloupes sold from a local farm in Colorado. The regulation would act as a security measure to potential foodborne illness problems. Product liability insurance protects individuals who are producing goods for sale and would protect them in the event the product would cause harm to the user. There have been mixed responses to the new requirement.

While there is a general understanding of the need for such insurance, some feel the costs outweigh the benefits. The concern is that the requirement will hinder affordability, growth, and overall diversity of the market. These concerns come from the burden being placed on small-producing farmers who’ve expressed that they will not be able to participate with the new requirement. Farmers who produce at greater quantities already have regulations on the insurance they carry.   In addition, most make enough profit to afford the premiums with little impact. One local farmer expresses “$420 for a year is so far the cheapest” premium he can find, inferring it is not cheap to afford the insurance.

Small farmers may have a hard time affording the insurance because they produce fewer amounts and make less profit. Having to incur this new expense, leads to another concern that the cost of the product will increase. The thought is since the cost to grow the product increases, so will the amount the good costs to the consumer. The farmer will have to compensate for the increase of production. The overall concern is this measure will turn away the number of vendors who will participate in the market since many of them are small-growers.

Farmer markets highly consist of these small-based farmers. If these growers are not able to participate the selection of goods will decrease. While there is no immediate impact yet, the market officially opened this past weekend with the new regulation implemented.
 

At Home Bakers Hail State's New Cottage Food Act

The Cottage Food Act of Washington passed by the legislature last year could go in effect as soon as this summer. The Act would benefit home-based entrepreneurs who want to sell their own baked goods.

The Washington State Department of Agriculture would administer the new law. The act would allow home-bakers to apply for licenses to sell their products (or simply, operate a legal home bakery). Currently, it is illegal the sell your own baked-goods, if they are not produced in a commercial kitchen in the state of Washington.

The Act would regulate many aspects of this growing movement. Only certain “lower-risk” foods would be encompassed in the act. These foods include breads, cookies, granola, cakes, nuts, jellies, and jams. The Washington Department of Agriculture would require a once-a-year inspection. To pass inspections kitchen surfaces and floors must be smooth. In addition, pets and children under the age of 6 years old must be kept out of the kitchens.

However, the kitchens do not necessarily need to be equipped with amenities associated with commercial kitchens. Not only is the environment of the kitchen regulated, so is the revenue. Since the Act is supposed to boost start-up business without costs of overhead, the amount of revenue made is capped. The Act would limit a business to $15,000.00 of revenue. Though this may seem like a low number, advocate and baker, Felicia Hill, explained, “the [$15,000.00] limit is better than the $5,000.00 original budget proposed in the Legislature.”

The revenue and environment are not the only factors regulated, so is the distribution. Cooks would only be allowed to sell to the consumer-directly (i.e. out of their homes or at farmer markets). They would not be able to sell by mail order or over the internet.

The Washington Department of Agriculture is expecting a positive turn out. Over 250 home-based businesses in the state have applied for the license. They are estimating to have eventually over 1,000 business to apply.
 

Global Green, Inc. Announces Conclusion of Final Study for USDA Approval of Salmonella Vaccine

Global Green, Inc. recently announced they received their final report on their study involving the “Salmogenics Vaccine” aka the Salmonella vaccine.

The original idea was developed by the National Health Institute Laboratories, LLC. Global Green, Inc. plans to manufacture, market, and sell the patented and licensed vaccine. The company has received approval from Financial Industry Regulatory Authority (FINRA) to trade publically on the Over-the-Counter (OTC) market and have applied for direct-to-consumer advertising (DTC) approval. The vaccine is currently in the final stages of the USDA approval process.

    

The study tested over 3,000 broiler chickens eggs that were injected with the vaccine. The study showed a remarkable reduction in salmonella bacteria and appeared to provide considerable protection against all salmonella strains. The study concludes reducing salmonella in chickens before they are processed and sold to the public will decrease the overall salmonella level.

Salmogenics uses a unique application process, in which the egg is directly injected with the vaccine. It is the only salmonella-fighting vaccine that uses this method. The vaccine also benefits the chicken’s immune system, health, and overall welfare. Using this technique will also result in reduced levels of salmonella in flocks and contamination risk in the processing stage. When salmonella is found in a flock during the processing stage, often times the contaminated meat has been distributed publicly.

While the final costs of the vaccine are unknown, the vaccine could be a cost-benefit alternative. Since the vaccine can be administered either alone or with other vaccines it can decrease the potential costs to the farmer. Because the vaccine is injected during the egg stage, the cost of human-handling is diminished and stress to the bird to is eliminated. The preventative measure of the vaccine could also cut back on contamination expenses. When meat is contaminated, the cost to correct the issue can be exorbitant. Since the vaccine would reduce the risk of contamination these potential costs would be avoided.

The Salmogenics vaccine has gained much industry support. Industry experts feel that this new approach is vital considering traditional approaches have ignored this method. James McNaughton, PhD explains, “A salmonella vaccine addressing vigorous strains that are hard to destroy is important.” AHPharma conducted the final report that point to positive signs that this will ultimately be passed by the USDA. This would be another preventive measure in foodborne illness.
 

Cantaloupe Handlers Approve First Mandatory Food Safety Program

California Cantaloupe handlers recently and unanimously passed the state’s first mandatory food safety program.

Even though California cantaloupes have never been linked to a foodborne illness, this action will add another layer of insurance to that segment of the state's industry.

The program solidifies the past two decades of food safety leadership demonstrated by the state’s cantaloupe growers. They have been working diligently to revise existing federal food safety guidelines pertaining to growing and packing. In addition they have been working to promote international food safety guidelines with contract science-based risk assessment associations and the Center for Food Safety.

This program will affect California cantaloupe growers statewide, specifically the Southern region. A new growing district will be established consisting of the desert south. The California Department of Food and Agriculture will appoint members for this new district from nominations at the previous public hearing in March. The group will implement the new mandatory program by conducting a board meeting to elect officers for the new districts. They will then determine the best way to regulate the industry modeling after other commodity-based programs.

The California Cantaloupe Advisory Board will also include a food safety certification program that will require compliance to production and handling. Failure to comply will make it an unfair trade practice. The unanimous approval of this mandate is significant since California Cantaloupe growers compromise 70% of the nation’s cantaloupe growers.

For this reason, the program will serve as an example for further mandatory food safety programs both domestically and internationally.
 

Managing Foodborne Illness Outbreaks, Recalls and Claims

A long-time industry colleague recently told me that it was the things he couldn’t see which he feared most. Lurking somewhere in his processing equipment, or on a product sitting in a sales cooler, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

Over the last decade, foodborne illness outbreak surveillance has improved significantly.  As a result of improved surveillance, more illnesses are being identified and more outbreaks are being reported. By extension, many of these outbreaks are being associated with an increasing number of food products (ranging from waffles to cookie dough) and more companies are being affected.

These improvements, while having an overall positive impact on public health, have also had a tremendous (and sometimes less than positive) impact on the food industry.

Indeed, literally thousands of spotlights (taking various forms) are now steadily and continuously crisscrossing the nation, searching for problems in our food products.  These “spotlights” take the form of verification testing by processors, incoming product testing by customers, regulatory sampling by federal inspectors and patient isolate testing ordered by concerned physicians.  With such vast resources being dedicated to looking for problems in today’s food, the question is not whether your product will be caught in the spotlight.  The real question is when.

Thus, assuming contamination is inevitable, and assuming that (once a product leaves your control) that contamination will be found, all food companies should begin planning now for how they will react if and when a outbreak or recall occurs. 

Fortunately, with advance planning, a company can begin limiting the fallout from an outbreak-related crisis the moment it learns about a potential problem. After learning that its product may be associated with an emerging outbreak, any company should immediately and directly engage federal, state and local health investigators. Proactive engagement is essential to: (1) quickly identify and then contain the problem (i.e., keep the problem from expanding); (2) help solve the immediate public health issue; and (3) ensure that the continuing investigation is conducted appropriately.  These steps are critical for numerous reasons. 

First, in the food industry, we know that the potential downstream consequences of any upstream food safety problems can also be catastrophic.  Just consider, for a moment, the processing of ready-to-eat food products. If a single raw material supplier unknowingly introduces contaminated ingredients into the supply stream, each of the downstream products manufactured with those ingredients will be affected. Thus, when product contamination is suspected, it is critical to identify all potentially affected lots and notify all customers to contain all affected product.  Doing so will help alleviate the impact of any possible contamination, and also demonstrate to investigators that your company is committed to protecting the public (in addition to being the “right thing” to do, this will also pay significant dividends in your dealings with the regulators following the recall).

In addition, it is important to recognize that public health officials are increasingly being asked to investigate and solve a growing number of overlapping outbreaks at any given time. With limited resources to conduct investigations properly and methodically, we have found that federal and state investigators will sometimes adopt and embrace incorrect assumptions about the source of an outbreak. And, whether explained by inadequate resources, limitations in time or a lack of individual expertise, once an incorrect hypothesis is embraced, it becomes very difficult for public health officials to admit possible errors, set aside potential bias and identify alternative sources.

For this reason, the moment any association is suspected, a food company should: (1) actively engage public health officials to address their immediate questions and concerns; (2) learn as much as possible about the status, scope and direction of the investigation; (3) aggressively identify the full range of potential cases and alternative sources; (4) politely but forcibly challenge, (where issues are identified) developing assumptions and hypotheses; and (5) persuasively demonstrate, where possible, that the company’s product is not likely involved. From our experience, investigators tend to be more open and thorough when all parties are actively engaged and at least someone – even if only emblematically – is looking over their shoulders.

In those circumstances where a company’s product is ultimately linked to an outbreak, and a recall is warranted, management should also begin anticipating and planning for the claims and lawsuits which will inevitably follow.  This, of course, includes enlisting experienced food safety regulatory and litigation counsel as early as possible in the investigative and recall process.

In addition to assisting with the recall itself, counsel should also be used to help address the regulatory issues which will follow. Once a recall is announced, federal investigators will often perform a comprehensive assessment of a food company’s operations to search for and “find” at least one problem.  These findings will then, in most instances, be documented in an FDA Letter of Warning or USDA Notice of Intended Enforcement. Unfortunately, this practice is followed even if a company was operating to virtual perfection. 

In turn, when responding to the government’s criticisms (whether warranted or not), it is critical for management to consider how each of the comments it makes will potentially impact future litigation. Certain regulatory “terms of art” often used in these communications are understood to have one meaning by government and industry, but can be mischaracterized by opposing counsel or misunderstood by a jury.

For this reason, management should carefully draft responses that: (1) put the recall into context; (2) articulate clearly the company’s position with respect to the alleged problem (even if it may differ from the government’s position); (3) detail each of the positive elements of the company’s food safety programs; and (4) address appropriately and artfully the governmental requests in a way that will be appreciated and understood by a jury.  Appreciating how the company’s post-recall communications with the government may be used by opposing counsel in lawsuits months or years later, can significantly reduce a company’s potential litigation exposure.  

When claims are eventually asserted, food companies should work with experience food safety litigation counsel.  This is because many companies (and their lawyers) managing a recall and outbreak for the first time are not equipped to effectively challenge any one of the complex epidemiological, microbiological and long-term damage issues often present in these cases.

In many lawsuits, significant questions also exist about the true source of a claimant’s illness.  Unfortunately, most people incorrectly believe that they got sick from the “last thing they ate.” In those cases where the target defendant is not at fault, the key to proving the company’s innocence often turns on a painstaking analysis of health department records, patient questionnaires, shipping records, witness interviews and key depositions.   

The emotional edge a plaintiff brings to the table can also be tempered in some cases by raising challenges to the source of the alleged illness.  If we can show significant problems with an outbreak investigation and its conclusions, or that our client produced and distributed thousands of safe and wholesome meals the week it processed the meal in question (and, the plaintiff was the only person who allegedly became ill), a jury will likely be more disposed to set aside emotion and focus instead on what really made the plaintiff sick.

Most jurors will also understand and appreciate a plaintiff’s obligation to exercise reasonable care for his or her own safety. Depending upon the circumstances, a plaintiff may have admitted to health department investigators eating a rare or undercooked hamburger despite the federally-mandated safe handling labels warning her not to.  Where a plaintiff shows no appreciation of the inherent risk, a jury will be more disposed to set aside sympathy and attribute fault to the plaintiff.

Additionally, many claimants (and their attorneys) will also significantly inflate and exaggerate damage claims to maximize potential recovery at settlement or trial. When a plaintiff’s overreaching is challenged appropriately and tactfully, his or her dishonesty in many cases will significantly diminish the potential sympathy a jury might otherwise be inclined to feel.  Thus, while emotion is always a factor, it can in many instances be effectively controlled.

In the end, our own mantra is “proudly defending the hard working people who feed our families.”  We believe strongly in this statement, and what it means.  Having worked with food companies for nearly a decade, we have observed (first hand) the valiant efforts of the hardworking individuals and food companies who labor tirelessly to improve the safety of our food.  Thus, in most cases, we will also have a great story to tell about the significant efforts our clients undertake to ensure the food they sell – and feed to their families – is as safe as it can be.

Although we enjoy one of the safest and affordable food supplies in the world, we continue to face incredible risk.  Because of improved surveillance, increased scrutiny from regulators, and a swelling interest from the media and lawyers, fewer mistakes are avoiding detection. Thus, it is critical for all companies to remember that, if there is a chance that your product can be contaminated, there is a significant chance that the contamination (whether through downstream testing or an emerging outbreak) will be found.

If it also critical for all food companies to begin planning and preparing for this contingency today.  No matter how hard you try, there are (and perhaps always will be) a few colonies of pathogenic bacteria in you equipment or coolers waiting patiently to wreak havoc in your business and lives.

** This article, authored by Shawn K. Stevens, is also featured in the April/May edition of Food Quality Magazine.

 

Testing the Tester [Part 2]

In my last column, I discussed how current FSIS policy (which invariably reacts critically to any positive testing results) discourages companies from aggressively testing to find pathogens in their products.

When adulterants are found in ground beef products, the results must be shared with FSIS and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, FSIS will use a company’s positive findings as a catalyst to aggressively and sometimes unreasonably second-guess its actions and response. 

This costly and unwarranted burden has, in many cases, discouraged the development and creation of truly effective testing programs by industry.

Now, FSIS is in the process of reviewing a petition from the Center for Science in the Public Interest which asks the agency to declare numerous strains of Salmonella as adulterants in raw meat and poultry.

The agency’s response to recent questions on this issue suggests that FSIS is seriously considering the policy. Dan Engeljohn, assistant administrator FSIS’s Office of Policy & Program Development, recently told attendees at an annual meat industry conference that FSIS is currently “assessing [the policy], and how we’d go forward if we were to adopt it.”

This sounds to me like the decision has already been made.

As FSIS considers it next steps, however, it needs to maintain a reasoned approach which recognizes the fact that it is currently impossible, given current technology, to completely eradicate ubiquitous organisms from raw beef and poultry products.  For this reason, whatever policy FSIS develops, the agency should at the same time reassess how it will react and respond to processors who aggressively test to find Salmonella (or other pathogens) in their products.

From my experience, the majority of beef processors would welcome additional controls aimed at reducing the numbers and levels of pathogens in incoming raw trim used to process hamburger.  If, however, the agency continues to penalize (rather congratulate) processors who test for and then find these pathogens in their finished products, then our food supply will not likely become any more safe.

Thus, in my view, as FSIS considers its policy going forward, the agency should also recognize that it has an unparalleled opportunity to develop and embrace rules that adequately enforce the new standards at slaughter, but also encourage (rather than discourage) additional testing.  If FSIS can incentivize the creation of new cutting-edge programs designed to find pathogens in products before they reach consumers, as opposed to destroying any incentive to test and find (through its often oppressive reaction when pathogens are found), then the agency will have substantially advanced the calling of food safety. 

So, as we wait with interest to see whether FSIS will declare Salmonella as an adulterant, we also wait to see if FSIS will continue to unfairly (and, in my view, improperly) test the tester.

** This article, authored by Shawn K. Stevens, is also featured in the April edition of the National Provisioner.

 

Testing the Tester [Part 1]

Microbiological sampling is an effective tool to help companies verify that their interventions are working. But how much testing is really expedient given the current food safety climate?

Today, many companies are testing for Listeria, Salmonella, E. coli O157:H7, generic E. coli, various other indicator organisms and, now, six additional STECs. Many companies perform raw material sampling, environmental sampling, equipment sampling and finished product sampling.

Even so, some argue, it is still not enough.

Unfortunately, not even companies on the cutting edge of food safety, who have implemented state of the art testing programs which far exceed FSIS requirements, are immune from outbreaks, recalls and criticism. This is because testing can never provide a one hundred percent guarantee that a product is sterile. Contamination in foods is by nature quite sporadic and, thus, difficult to detect.

Although finished ground beef product testing is not mandated by federal law, many companies nevertheless embrace finished product testing as a means to better monitor their processes and to further enhance the safety of their products. These companies not only deserve our commendation, but they also deserve to be treated better by USDA.

This is because current USDA policy discourages companies from finding pathogens in their products. When E. coli O157:H7 is found, the results must be reported to USDA, and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, USDA will use a company’s positive findings as a catalyst to aggressively second-guess its actions and response.

Indeed, rather than allowing processors who test and find to quickly address those findings and divert affected product, the agency too often responds with additional regulatory intrusion and unwarranted criticism. Moreover, the more companies test, and the more they find, the more onerous and oppressive agency intervention can and potentially will become. Similarly, in the unfortunate event that a company (despite its best efforts) finds itself associated with an outbreak or recall, USDA is virtually certain to conclude in a Notice of Intended Enforcement issued following the recall that the companies’ testing program was somehow deficient – no matter how good the program actually was.

This reality, unfortunately, demonstrates the glaring disconnect between the science of food safety and the expectations of regulatory inspectors.

Thus, although companies that perform more testing stand a far better chance of finding contamination and reducing their risk of being associated with an outbreak or recall, they cannot reduce the risk entirely. Thus, to encourage more (not less) sampling, USDA should begin adjusting its policies to create more (not less) incentive for companies to test to find.

If we are to make further strides in food safety, we must develop science-based solutions which examine the root causes of contamination. And, USDA needs to take a closer look at how it responds to processors who aggressively test their finished products. In the end, it needs be pathogens – not companies doing the right thing – who feel they are being tested.

** This article, authored by Shawn K. Stevens, is also featured in the March edition of the National Provisioner.

FSIS Extends Deadline for Implementation of Non-O157:H7 STEC Rule

The USDA’s Food Safety and Inspection Service ("FSIS") recently announced that it will extend the agency’s implementation date for non-O157:H7 STEC sampling and testing to June 4, 2012.

The extension, according to FSIS, was announced to give establishments additional time to validate their test methods and detect non-O157:H7 STECs prior to entering the stream of commerce.

As part of its zero-tolerance policy for E. coli O157:H7, FSIS will begin sampling both domestically produced and imported raw beef manufacturing trimmings and other raw ground beef components for the serogroups O26, O103, O45, O111, O121 and O145.

In a statement, AMI Executive Vice President Jim Hodges applauded the temporary delay, but argued again that additional research is still needed given the significant shift in agency policy.

“Even with a 90 day delay, imposing this new regulatory program in June puts the cart before the horse and will needlessly cost tens of millions of federal and industry dollars – costs that likely will be borne by taxpayers and consumers. In short, the policy is not likely to yield a significant public health benefit and given that research should precede and dictate the policy, the process that FSIS has followed in this matter is no way to develop good public policy.”

In the end, significant questions still exist regarding the prevalence and virulence of non-O157:H7 STECs in beef products. Time will tell whether the substantial resources being directed toward these new pathogens will, indeed, translate into a substantial improvement in public health.

CDC Criticized For Outbreak Reporting Policy

Government health agencies have come under fire in recent days for the manner in which they conducted a recent foodborne illness investigation.

The CDC, in a final report of the outbreak, was criticized for referring only to a “Chain A” when describing a company that likely had been supplied with contaminated product, likely produce. The outbreak, and any possible attendant risk to public health, had ended by the time the report was published. The CDC determined that the contamination likely occurred before the product ever reached the restaurants.

Investigative efforts were unable to identify a specific food associated with illness, but data indicate that contamination likely occurred before the product reached Restaurant Chain A locations.

This outbreak now appears to be over.

Despite the reported unlikelihood of any possible additional risk, many are accusing the CDC of jeopardizing the public health by not identifying “Chain A.”

A Seattle-based plaintiffs’ food safety attorney has been leading the charge against the unnamed company, the FDA and the CDC. His complaints stem from CDC’s decision not to disclose the identity of the restaurant chain. It is his contention that “the public has a right to know and to use the information as it sees fit, and people – especially government employees – have no right to decide what we should and should not know.”

CDC’s policy, according to Robert Tauxe, is to disclose the identity of an outbreak source “only when people can use that information to take specific action to protect their health." While some decry the policy, it is in place to promote cooperation between governmental health agencies and companies that may be associated with illnesses.

On the one hand, cooperation between agencies and business during the course of an outbreak is critical. The most important thing, I think we can all agree, is to protect public health in the event of an ongoing outbreak. In the event that public health is at risk, CDC and FDA release the names of companies and the potentially implicated products.
Without cooperation, however, CDC investigators worry that it will take longer to identify the source of outbreaks, potentially resulting in unnecessary illnesses. Thus, if an outbreak is over, current policy is not to name the offending company. Often, as in this case, it is a supplier who provided the contaminated product and not the restaurant itself.

In the end, CDC is not interested in blaming or punishing. Their job is to protect the public from health hazards and they feel they can better accomplish that by not revealing the names of companies who received contaminated products.

Others, however, take the position that it is a consumer’s right to know if a restaurant is associated with an outbreak, even after it is over. They argue that, when it comes to public health, it is not for the government to decide what information people should and should not have access to.

In the case of the outbreak at issue, the investigation revealed:

Collaborative investigative efforts of state, local, and federal public health agencies indicated that eating food from a Mexican-style fast food restaurant chain, Restaurant Chain A, was associated with some illnesses.

CDC and FDA do the best they can with the resources they have. Their investigation showed a statistical association between the outbreak and the restaurant chain. The restaurant chain, in turn, did all it could to assist the CDC in determining the root source. This cooperation is reflected in the CDC report:

Restaurant Chain A, as well as their food suppliers and distributors, were very cooperative in providing extensive information to public health officials as various leads were explored.

Unfortunately, notwithstanding its best efforts, the CDC was unable to trace the illnesses back to a single product. Tracing microscopic bacteria to a single source can in some cases be very challenging. But to accuse the CDC of colluding to make people sick because it didn’t reveal the name of a company that may itself have been a victim of the outbreak is inappropriate.

Both the restaurant chain and the agencies involved in investigating the outbreak deserve to be praised for their cooperation in trying to determine the source of this outbreak. The chain at issue did not contaminate the food, it arrived that way. As such, there is absolutely no reason to openly criticize the company, especially in light of its own efforts to help CDC and FDA prevent further illness.

Here is a link to the CDC report: I think it is actually rather impressive.

http://www.cdc.gov/salmonella/restaurant-enteriditis/011912/index.html

FSMA: A One Year Progress Report

On January 4, 2011, President Obama signed the Food Safety Modernization Act ("FSMA").

Since FSMA was signed into law, the FDA has made significant progress in a number of areas. Although not all of the changes expected under the FSMA have gone into effect, many of the changes have already been implemented.  In the past year, for instance, the agency has implemented the following initiatives quickly and with minimal confusion:

  • Consumer-Friendly Web Search for Recalls. FDA launched a more consumer-friendly recall search engine on the FDA website.
  • Guidance to Seafood Industry on Food Safety Hazards. FDA issued its updated guide to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards.
  • Administrative Detention of Foods. Allows FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed. FDA has begun using this authority.
  • Prior Notice of Imported Food. FDA issued an interim final rule that requires 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.
  • Joint Anti-Smuggling Strategy. FDA and the Department of Homeland Security issued a joint anti-smuggling strategy to help to identify and prevent smuggled foods from entering the U.S. and posing a threat to national security and consumer safety.
  • Fee Schedule. FDA announced the fiscal year 2012 fee schedule for certain domestic and foreign facility re-inspections and for failure to comply with recall orders.
  • Authority to Suspend the Registration of Food Facilities. FDA has the authority to suspend the registration of food facilities to prevent the import and export into the U.S. in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
  • Product Tracing Pilots Launched. FDA announced that the Institute of Food Technologists (IFT) will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
     

Reportedly, the FDA has also met the FSMA mandate for foreign inspections. For domestic inspections, the FSMA mandate is based on a 5-year time period.

In the past year, FDA has defined its high-risk and non-high-risk domestic food facility inventories and in FY11, FDA and various state partners conducted more than 20,000 food facility inspections. At this rate the Agency will likely meet the domestic food inspection frequency mandates contained within FSMA. In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit.

Communication and outreach have also played an important role as FDA implements the various FSMA provisions.

  • FDA has participated in more than 350 meetings with industry leaders, farmers, consumers, public officials, and academics.
  • On produce safety, FDA has worked very closely with USDA, which has an established relationship with farmers, and taken part in 14 farm tours across the country to gather input on how the proposed rules can work feasibly across the diversity of commodities and growing conditions and practices.
  • FDA, the US Department of Agriculture, and the National Institute of Food and Agriculture entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training and other projects.
  • FDA held three public meetings on preventive controls, import provisions, and changes to inspection and compliance programs in a preventive controls environment.
  • FDA has participated in more than 70 meetings globally to discuss the international impact of FSMA. This includes trips by the Deputy Commissioner for Foods to China, Mexico, Canada and the European Union.
  • FDA participated in, and helped fund, the establishment of the Produce Safety Alliance and the Food Safety Preventive Controls Alliance to help industry, especially small and very small firms, to comply with the requirements.
  • FDA provided information to the business community through the extension services of 49 land-grant colleges and universities.
  • FDA established a FSMA webpage that now has more than 10,000 subscribers, includes more than 100 Frequently Asked Questions by topic, and features videos, webinars, presentations, and print materials.

While the impact of many of the changes implemented by FDA to date have been relatively minor, some of the most comprehensive regulatory changes – such as the requirement that food companies adopt written food safety plans – are still to come. We, of course, continue wait in earnest to see, exactly, what the agency has in store.

The Food Safety Modernization Act: Are We Almost There Yet?

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.
 

Whether You Like It Or Not, Plaintiffs' Lawyers Have To Eat Too

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.

 

Not a Happy Campylobacter

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.
 

Getting To The CORE Of Foodborne Illness Outbreaks

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.
 

We Think We Have An Adequate Food Safety Plan, But How Will It Be Enforced?

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.
 

USDA Formalizes Rules On Non-O157:H7 STECs

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. 

USDA Declares "Big Six" Non-O157:H7 STECs As Adulterants

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 13th, 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.

The New Food Safety Modernization Act: What IS a Food Safety Plan?

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;
  1. Determine Critical Control Points: Identify appropriate critical control points (“CCPs”) where a control measure can be applied to prevent or reduce an identified hazard;
  1. 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.
  1. Establish Monitoring Procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits which may occur; 
  1. 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;   
  1. Establish Verification Procedures: Test and critique the HACCP plan, once designed (and periodically thereafter), to verify that the HACCP plan is working correctly;
  1. 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.

The Food Safety Modernization Act: FDA's Six Month "Progress Report"

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.
 

FDA Continues Work On Rules Governing Preventative Controls

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.
 

Should State and Local Health Departments Be Accredited?

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.

OIG Questions E. coli O157:H7 Testing; Still No Approval Of Carcass Irradiation

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.
 

Staphylococcus In Raw Animal Products Likely Creates Little Cause For Concern

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.

The New Food Safety Modernization Act (FSMA) - What Your Company Needs To Know

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:

 

Salmonella Remains In The Spotlight

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.

The Reportable Food Registry: Food Companies Continue To Fall Under FDA Scrutiny

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.
 

Deli Slicers And Food Safety: What Your Company Needs To Know

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.
 

What Does The New Food Safety Modernization Act Mean To Your Business?

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.

CDC Revises Annual Foodborne Illness Estimates

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.

FDA's Food Safety Modernization Act Will Soon Become Law

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.
 

FSIS To Place Additional Emphasis On Pre-Harvest And Carcass Interventions

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.
 

Non-O157:H7 STEC Debate Continues

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.

National Food Safety Defense Firm Continues To Lead The Way

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.
 

High Pressure Processing Continues To Show Incredible Promise

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!

The West Wasn't Won On Salads

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.

The Reportable Food Registry: A Year In Review

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.

Reportable Food Registry: Important Guidance For Food Companies

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.).

White House Renews Discussions About Safe And Healthy Food

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.

Would Your Own Kitchen Pass A Health Department Inspection?

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.

September Is Food Safety Education Month

          

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:

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.

Eggs: Rapid Cooling Could Limit Rapid Fire

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.

Tracking Overall Progress On Food Safety

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.

DeLauro Introduces Stringent "E. coli Traceability And Eradication Act"

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.

Stevens Champions New Meatingplace Food Liability Blog

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 MeatingplaceLegally 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 foodsafetycounsel.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.

IAFP Annual Conference A Huge Success

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 100th Year Anniversary – to Milwaukee.

Is The Food Safety Working Group Still Working?

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 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.

Enhancing Traceability And Outbreak Response

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.

FSIS Publicizes Newly Approved Food Safety Technologies

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.

FMI Releases Norovirus Guide For Industry

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.

Food Safety On Big City Streets

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…

Meat And Poultry - Bringing The World Just A Little Bit Closer

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.

Oysters And Oil: Coastal States Struggle With Seafood Safety

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.

Contingency Planning And Crisis Management: Is Your Company Really Recall Ready?

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.

FDA Publishes New Guidelines For The Reportable Food Registry

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.

Clarification Creates Confusion: Final Comments Received On FSIS' Preliminary Validation Guidance

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.

New Study Confirms That UV Light Is Effective In Reducing Listeria On Broad Range Of Food Product Conveyor Belts

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.

Proposed Legislation Seeks To Label Non-O157 STECs As Adulterants In Beef

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.

Scientific Breakthrough Prevents E. coli From Surviving In Cattle

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."

Possible Salmonella Concerns Prompt Voluntary And Precautionary Sprout Recall

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.

USDA Sets New Pathogen Standards For Poultry

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. 

E. coli O145 Concerns Prompt Lettuce Recall

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."

Walmart Sets New Standards For Beef Suppliers

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.

X-Ray Technology Could Be Viable Alternative To Kill Pathogens

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.

E. coli O157:H7 Cases Decline In 2009, Meeting 2010 Healthy People Goals

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.”

Federal Court Dismisses Lawsuit Attempting To Link Hot Dogs To Cancer

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.

Hawaii Recognized For Quality Of Food-Borne Illness Investigations

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.

Consumers vs. Companies: Are We Each REALLY Doing Our Part To Prevent Food-Borne Illness?

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.

People vs. Products: 70 Percent Of Food-Borne Illness Caused By Food Handlers

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.

Food Requires Proper Handing: FDA Video Helps Consumers Avoid Avoidable Food-Borne Illness

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.

 

 

Food Safety To Be Featured At 2010 DRI Product Liability Conference In Las Vegas

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!

HVP Recalls Trigger New FSIS Labeling Guidance

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.

When Are Food Companies Required To Report Potentially Dangerous Foods Under The FDA Reportable Food Registry?

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.

Uncovering The Truth In Food-Borne Illness And Outbreak Litigation

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:

 

 

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. 

Nationwide Recall of Hydrolyzed Vegetable Protein Triggered By Salmonella Concerns

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.

Food Companies Now Have Obligation To Report Potentially Dangerous Foods Under FDA Reportable Food Registry

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.

Salmonella Concerns Prompt Recall Of French Dip Powdered Au Jus Products

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).

Salmonella Outbreak Traced To Red Pepper

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.

FSIS Responds To Petition By Plaintiffs' Attorney To Declare Non-O157 STECs Adulterants In Beef

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.

Mande Calls For More Rapid, Robust And Reaching Pathogen Testing

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.

Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology

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.

Defending High-Profile Food-Borne Illness Outbreaks And Claims

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.

Elisabeth Hagen Selected To Become Under Secretary For Food Safety

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.

Nationwide Salmonella Concerns Trigger Precautionary Sausage Recall

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.

Mike Taylor Appointed To New Food Safety Post

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.

E. Coli Concerns Prompt Ground Beef Recall

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.

Listeria Concerns Prompt Recall Of Numerous Peanut Butter, Cheese, Salsa And Other Products

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.

USDA Announces New E. coli O157:H7 Vaccines

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 Nationa