Food Safety News

Keeping Tradition Alive (despite the risks)

dstearns@marlerclark.com (Denis Stearns) — Fri, 19 Mar 2010 01:59:03 -0800

There is much to be said for tradition, especially as it relates to food. When my mother was alive, her tradition at Christmas was to make twice-baked potatoes, which she prepared the day ahead and set in the garage to await baking at the appointed time. It was not particularly cold in the garage, and I always wondered about the safety of her practice (me being an attorney who represents victims of foodborne illness). But no one ever got sick from eating these deliciously creamy, cheese-topped potatoes, and I never said word-one to my mother about the possibility of her putting her family at risk.

And that is the funny thing about tradition. When something is done a certain way for a long period of time, and doing it that way always seems to work, there will always be strong resistance to change. Indeed, the response--We've always done it this way--is typically accepted as a sufficient justification for just about anything, including a decades-old cooking procedure for the ground beef used in Maid-Rite sandwiches. Over the protests of many, including public health professionals, physicians, and my law partner, Bill Marler, it appears that the Iowa Legislature is about to grant a legal waiver that would allow certain Maid-Rite franchises to continue cooking ground beef as originally done by the creators of this Midwestern classic, loose-meat sandwich.[1] This is how the ongoing dispute was described in the Des Moines Register:

"The Iowa Department of Inspections and Appeals has told Taylor's Maid-Rite restaurant that it must alter its process for cooking the company's loose-meat sandwiches. The process at Taylor's involves cooked hamburger being placed in the same heated receptacle that's used to cook raw meat. It's a practice that state and federal officials, as well as the Maid-Rite Corp. and the Iowa Environmental Health Association, say is unsafe and could lead to cross-contamination.

"The restaurant's owners, Don and Sandy Short, are refusing to change the process. They say their cooking methods represent a tradition that dates back 80 years.

"Last week, they handed out Maid-Rites to lawmakers and asked them to intervene. On Tuesday, Sen. Steven Sodders, D-State Center, did just that. Sodders introduced an amendment to a bill that provides funding for the entire inspections department. The amendment would enable Maid-Rite restaurants that still use the old method of cooking to continue to do so."[2]

Defending the proposed waiver, Senator Sodders framed the tradition-versus-safety question well. "I think we have to look at tradition," he said. "I'm representing my district, and the people there, far and away, would like Taylor's to continue to prepare their Maid-Rites in the traditional way." Such protection of a "traditional way" also encompasses a political argument that is decidedly libertarian in its approach. For example, the creator of a Facebook fan page intended to drum up support for Taylor's Maid-Rite is quoted as saying: "It's not about loose-meat sandwiches. It's about this family....It's time for the government to leave this family alone."[3] Thus, apparently some see the attempt to uniformly enforce food safety rules on all restaurants as an attack not only on tradition, but on a family too.

Such hyperbole in defense of family and tradition is neither surprising nor terribly troubling. But when hyperbole becomes winning argument there is much about which we should be concerned. For one thing, the defenders of "tradition" too conveniently overlook that "tradition" is a decidedly fluid thing. As pointed out in the Des Moines Register article: "By all accounts, the cooking method used by Taylor's was abandoned years ago by most other Maid-Rites. Those restaurants place their cooked meat in a container that's segregated from meat still being cooked." Secondly, we should be cautious about the weight that we grant the label of "tradition" in justifying a practice that, in its absence, few if any would defend.

This latter point was well made in the editorial published in the Des Moines Register, in which it criticized the idea that "siding with tradition" was defense enough to a practice that could put the public health in danger. The editorial ends, stating:

"[Supporters of Taylor's Maid-Rite] apparently think a practice is OK just because it's been around for many years. But that's a fallacy. It's why people wear seat belts and doctors don't 'bleed' patients to cure diseases and employees aren't smoking in the office now. When we realize there are safer ways of doing things to protect lives, we do them.

"When Iowa lawmakers cook at home, they can do whatever they want. They don't have to wash their hands. They can lick the spatula or eat hamburger raw, if they so desire.

"But Iowa businesses serving customers need to implement basic practices to ensure food is safe. That should be this state's 'tradition.'"[4]

This distinction--between food-traditions followed at home, versus those marketed for commercial purposes to the public--is an important one to keep in mind. Although our instinct is no doubt to protect tradition from the in-roads of technology and modern ways, tradition cannot always be protected solely for the sake of tradition itself. In making her delicious twice-baked potatoes, my mother would have never put her family knowingly at risk, and, I am sure, never did. There was nothing used to make those potatoes that could not, for the most part, be safely kept in the cool-but-not-below-40-degrees of the garage. And, in any case, the potatoes were cooked in a hot oven to crispy perfection, reaching temperatures more than sufficient to kill whatever pathogens could have been present. Even so, I am certain that if I had told her of a specific safety risk, she would have happily changed tradition to keep her family safe. I wonder then, why it's so hard for Taylor's Maid-Rite to agree to such a change.

Could it be that the reluctance to change is really about the cost of new and safer equipment, and the restaurant's bottom-line? Would a business actually put profits above safety? Now there's an American "tradition" that's easy to recognize!

Footnotes

1. Coincidentally, I have actually eaten a Maid-Rite loose-meat sandwich. While working on a case arising from an E. coli O157:H7 outbreak in Northern Minnesota, an outbreak linked to meatballs served as part of a smorgasbord at the Salem Lutheran Church in Longville. At least 17 people became ill as part of this outbreak, and, tragically, one woman died. (You can read about this outbreak, and the resulting litigation, here: http://www.nytimes.com/2008/06/08/business/08feed.html) In my travels "up north," on several occasions I flew into Brainerd and stayed overnight there. Because my father, also recently passed, was born there, I decided to try to find some "authentic" place to eat, since I have always thought that the way to get a feel for a place is to eat where the locals have been eating for decades. The place that I found to eat was The Barn, which opened in 1945 by a family from Iowa. It was part of the original Maid-Rite franchise, and so it has been serving Maid-Rite loose-meat sandwiches for a long time. From all reports, The Barn is also well known for its home-made pies, which excited me to no end, because I love good pie. I ended up stopping at The Barn on my way to the airport, having an hour or so to kill before I had to catch my flight to Minneapolis, from where I would fly home to Seattle. Once settled in at the counter, I ordered a Maid-Rite Sandwich with mustard and pickles, having learned somehow (I can't remember where) that it is sacrilege to put ketchup on a Maid-Rite sandwich. I also ordered a slice of peach pie. The verdict? I found the Maid-Rite Sandwich on the dry side, and not terribly flavorful, despite the hefty squirt of mustard, and the pickles. This is no doubt the result of the fat being cooked away, leaving behind crumbly, dry bits of ground beef. So I was not terribly impressed, although I must admit that I'm a big fan of sloppy joes, so I was probably biased against a dry loose-meat sandwich from the start. As for the pie? It was dreadful. So sweet that it made my teeth hurt. The crust was excellent, however, which is really what matters most with pie.

2. Clark Kaufman, "Is Marshalltown Maid-Rite's process safe or not?" Des Moines Register, Mar. 10, 2010, online at http://www.desmoinesregister.com/article/20100310/NEWS10/3100359/Is-Marshalltown-Maid-Rite-s-process-safe-or-not See also Dave DeWitte, "State Examines Safety of Marshalltown Maid-Rite's Loose Meat," at http://www.kcrg.com/news/business/87114227.html

3. Ken Black, "Rally draws support for Taylor's Made-Rite," Times Republican, March 13, 2010, at http://www.kcrg.com/news/business/87114227.html

4. "Make sure Maid-Rites aren't made wrong," Des Moines Register, March 15, 2010, available at http://www.desmoinesregister.com/article/20100315/OPINION03/3150303/Make-sure-Maid-Rites-aren-t-made-wrong

Why Did Whole Foods Stop Selling Raw Milk?

bmarler@marlerclark.com (Bill Marler) — Mon, 15 Mar 2010 01:59:03 -0800

Why did Whole Foods stop selling raw milk in California, Washington, Pennsylvania, and Connecticut?

In January, I wrote “Risky Business - Why would a retailer like Whole Foods sell Raw Milk?” – perhaps Whole Foods actually paid attention? In the last two years I have spoken at various conferences of the financial risks--specifically to retailers and insurers--of selling raw milk. Over the weekend Whole Foods stopped raw milk sales in California, Washington, Pennsylvania, and Connecticut. Insurers are leaving the market. Why did they do it?

Here are the reasons: over the past several years, I have represented several families of children whose parents purchased raw milk directly from the farmer. The children came away with E. coli O157:H7 bacteria-mediated Hemolytic Uremic Syndrome, months of hospitalization, hundreds of thousands of dollars in medical expenses, and millions of dollars in risk of future complications, including end stage renal disease and the need for multiple kidney transplants.

I also presently represent two people (one child and one adult) from Connecticut who consumed raw milk purchased at a Whole Foods. The milk was contaminated with E. coli O157:H7. Both developed Hemolytic Uremic Syndrome. Once again, hundreds of thousands of dollars in medical expenses have been incurred. One victim, a twenty-eight year old mother, will likely require a kidney transplant--again, at a multiple million-dollar cost.

Now for the risky part to retailers and insurers: most, if not all, raw milk farmers have limited insurance and very few assets that are not owned solely by the bank. If they face litigation for poisoning a customer, bankruptcy is always an option and what insurance is available is paid.

But, what about the risk to the retailer? True, in selling raw milk they are “only” selling a product that has a history of sickening consumers – they did not manufacture it.

So, is a retailer, like Whole Foods, liable for paying millions of dollars to its customers if they are sickened by raw milk? The short answer is--Hell yes! The reality in most states is that the entire “chain of distribution,” whether you are a manufacturer (a farm is) or retailer, you are responsible if a product (raw milk is a product) causes harm. That means the farmer, the shipper, and the retailer will be responsible (morally and legally) to the consumer for all damages caused by the product. It is true that, depending on the state; a court may apportion damages between various members of the “chain.”

However, and this is key, if the original manufacturer (the farmer in this instance) is bankrupt or has limited assets (including insurance), the retailer may be left “holding the bag”--partially empty--that the retailer will need to fill. By way of example, assume that raw milk sold at a Whole Foods sickens five people. Two develop Hemolytic Uremic Syndrome. Assume further that the farm has only one million dollars in insurance and limited assets. Also assume that the total value of all cases (settlement or verdict) is ten million dollars. Guess who pays the nine?

So, why did they do it? They sold it because of money and they stopped selling it because of money.

Or, perhaps Whole Foods was paying attention to my speech at the AVMA:

More or Less Food Safety Regulation?

aweisbecker@marlerclark.com (Andy Weisbecker) — Thu, 11 Mar 2010 01:59:03 -0800

During the past weeks, a few news stories have highlighted the distinctions between two different legislative approaches to address the issue of food safety. There is little question that the public is becoming increasingly aware and concerned about the safety and quality of food. The impetus is accordingly growing across the country to get the pending FDA Food Safety Modernization Act, S. 510, which would give the FDA more authority and money, finally passed and enacted into law.

Opponents, however, argue that this legislation favors an industrial agricultural system, and that local food systems provide significant food safety benefits. In fact, in Wyoming and in Florida, state legislatures were considering bills to lessen the regulation of local "cottage" foods, with their proponents arguing at least in part that this approach would increase food safety.

An increasing number of Americans is justifiably becoming concerned about outbreaks of illness linked to contaminated food, and about the capacity of our existing food safety system. A September 2009 survey among likely voters across the nation found that about 9 in 10 support the federal government adopting additional food safety measures. Overall, 58 percent of voters were worried about bacterial contamination of the food supply--with about a third saying they worry "a great deal." The survey showed that American voters overwhelmingly believed the federal government should be responsible for protecting the food supply, and that the voters supported new measures to ensure it has the authority and capacity to do so.[1]

The public's increasing concern about food safety was recently validated by the results of a study on the cost of acute foodborne illnesses in the Unites States. The study by a former U.S. Food and Drug Administration (FDA) economist estimates the total economic impact of foodborne illness across the nation to be a combined $152 billion annually. The Centers for Disease Control and Prevention (CDC) estimates that approximately 76 million new cases of food-related illness--resulting in 5,000 deaths and 325,000 hospitalizations--occur in the United States each year. This recent study used an FDA cost-estimate approach: health-related costs were the sum of medical costs (physician services, pharmaceuticals, and hospital costs) and losses to quality of life (lost life expectancy, pain and suffering, and functional disability). The study ranked states according to their total costs related to foodborne illness, and determined the annual cost per case for an individual, which was approximately $1,850 on average per illness nationwide.[2]

Many have been pressing for changes in the food safety system to enhance the regulatory and enforcement authority of local, state, and federal agencies to inspect, investigate, and recall food products as needed. A report released in April 2009 called for leadership by Congress and the U.S. Department of Health and Human Services (HHS) to build an integrated national food safety system to make effective use of the best science and all available public resources to prevent foodborne illness. The report noted progress in how federal, state, and local agencies collaborate to detect foodborne outbreaks, but also found that state and local agencies are hampered in their response to and prevention of outbreaks by lack of focused federal leadership, chronic underfunding, wide disparities in capacity in all areas of food safety, and barriers to information sharing and collaboration. The report then made 19 specific recommendations for strengthening state and local roles, and for building an integrated national food safety system that works effectively to prevent foodborne illness.[3]

In October 2009, the American Public Health Association (APHA) recommended legislative changes to establish new authority to strengthen the food safety system. The APHA found that FDA lacks the authority to require tracking, maintenance, and access to records on foods, including fresh fruits and vegetables. The FDA does not have the authority to mandate a recall when a food is identified as contaminated or is a source of an outbreak. Also, limited funding at all levels restricts the ability of state and local health agencies to conduct robust prevention and surveillance activities. The APHA accordingly recommended legislation that would in part: improve coordination among local, state, and federal agencies to enhance surveillance, investigations, and response; implement national food safety plans, including testing, record maintenance, and reporting of positive contamination results; and authorize FDA mandatory recalls and tracebacks. The APHA finally supported food safety enhancement and modernization legislation then already pending in Congress.[4]

Most recently, "The Hill", a Capitol Hill newspaper, published several Op-Eds highlighting the bipartisan support for the pending FDA Food Safety Modernization Act, S. 510, and urging the Senate to act. Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, emphasized the broad, bipartisan support for S. 510, a bill that would increase the FDA's authority and capacity to regulate 80 percent of the food supply. Sen. Herb Kohl (D-WI), chairman of the Senate agriculture appropriations subcommittee, called for urgent action in his Op-Ed, stating that "The Senate must act this year to restore consumer confidence and ensure a safe and abundant food supply." Rep. Rosa DeLauro (D-CT), chairwoman of the House appropriations subcommittee, which oversees the USDA and FDA budgets, called for simplifying the food safety system by centralizing food safety activities into one agency.[5]

In sharp contrast, however, recent headlines have also highlighted a quite different approach to the issue. This other approach in fact favors reducing food safety inspections, certifications, and similar regulations, advocating instead for the increased freedom of local producers to produce and market their products. State legislators in Wyoming and Florida have recently been working to enact similarly inspired "Food Freedom Acts".

House Bill 54, the Wyoming Food Freedom Act, passed out of a Wyoming House committee on February 18, 2010. The bill proposed to exempt all "cottage foods", or foods prepared in home kitchens, including potentially hazardous foods such as dairy products, canned foods, and sauces, from regulation. The stated purpose of the bill was "...to allow for traditional community social events involving the sale and consumption of homemade foods and to encourage the expansion and accessibility of farmers' markets, roadside stands, ranch, farm, and home based sales and producer to end consumer agricultural sales ...".

Those in favor of the Wyoming Food Freedom Act claimed it would allow small farmers and food producers to sell direct to consumers without their need to spend the significant funds required to get proper certifications--a financial burden that can put small farmers and food producers out of business. As regards food safety, proponents argued that industrialized and inspected foods are no guarantee of safety, and that the highest quality, and most nutrient-dense food is the closest to the source. Also, those in favor of the bill claimed that community fosters responsibility, and that local producers who sold low quality and unsafe food would have to answer to their neighbors and would not be in business long.[6]

Critics, however, fear the increased risk for foodborne illness outbreaks if House Bill 54 passed into law. Those in opposition to the bill supported the inspection and licensing process in place because it allows inspectors to help cottage businesses minimize the risk of distributing foods contaminated with foodborne pathogens. Ultimately, they prevailed, and despite passing through the House Committee, the bill failed to pass through the Senate Agriculture Committee on February 26, 2010, effectively shelving the legislation, at least for this session.

In the meantime, in Florida, legislators are debating the merits of the proposed Florida Food Freedom Act. The articulated purpose of the Act is to initiate lighter inspection from USDA for small farmers. The Florida Food Freedom Act would define a single link food distribution chain that starts with the food producer, or the producer's agent, and ends with the consumer.  The Act would then exempt that single link food distribution chain from the regulatory oversight that a longer, multi-layered food distribution chain would be required to have.   Its proponents argue that the Act would allow family farms to remain profitable and viable, creating new local businesses and jobs, as well as feeding the growing demand for locally grown food.[7]

Advocates for the Act also claim that it would enhance food safety. They argue in part that the closer relationship between the producer and the consumer, including the producer's integrity and the consumer's interest in and knowledge of how the food is raised, harvested, and prepared, would provide sufficient oversight.  The biggest threats to food safety are claimed to be centralized production, centralized processing, and long distance transportation. Small farms and local food processors would instead be part of the solution to food safety, as local food systems are inherently safer and more traceable. Additionally, the Florida Food Freedom Act would require all people selling directly to the end consumer to become certified food protection managers.[8]

It is likely that the substantial differences in these approaches for legislation to increase food safety are primarily a function of different political philosophies and economic agendas, as well as concern with the safety of food products. It is somewhat comforting, however, that the importance of improving food safety as a necessary goal is increasingly acknowledged and recognized, regardless of the diversity of means proposed to attain that goal.

REFERENCES:

1.   Pew Charitable Trusts, Commissioned Survey: "Americans' Attitudes on Food Safety", September 2009. Available at www.makeourfoodsafe.org.

2.   "Health-Related Costs from Foodborne Illness in the United States", Robert L. Scharff, March 2010, Produce Safety Project. Available at www.producesafetyproject.org.

3.   " Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation's Food Safety System", Department of Health Policy at the George Washington University School of Public Health and Health Services, with the Association of Food and Drug Officials (AFDO), the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO), April 17, 2009.

4.   "Creating a Safe Food System for America", American Public Health Association, Issue Brief, October 2009.

5.   "More Calls for Senate to Act on Food Safety", Helena Bottemiller, Food Safety News, Feb 26, 2010.

6.   "Committee hears testimony on food freedom", Bill McCarthy, Wyoming Tribune Eagle, February, 17, 2010.

7.   "Florida Farmers Anxiously Await Florida Food Freedom Act", Suzanne Richmond, Orlando Gardening Examiner, February 22, 2010.

8.   "Support Florida Food Freedom Act", Farm-To-Consumer Legal Defense Fund, at the ftcldf.org website, last edited 2/26/2010.

Foodborne Illness By The Numbers

aferguson@marlerclark.com (Alex Ferguson) — Mon, 08 Mar 2010 01:59:03 -0800

Robert L. Scharff, with the help of funding from the Produce Safety Project at Georgetown University, recently published a study analyzing the financial impact of foodborne illness in the United States. Employing the same methods used by Food and Drug Administration (FDA) economists, Scharff estimates that the total cost of foodborne illness in the United States is a staggering $152 billion per year. This headline-grabbing number certainly calls attention to the significant yearly expenditures attributable to illnesses caused by foodborne pathogens. It is my belief, however, that the number is based on speculative data that, unfortunately, calls into question the accuracy of the results.

Before I begin my own analysis, let me be clear: I commend Scharff's efforts in publishing this study. Without a doubt, a significant amount of research went into this project, and the questionable results are not a product of the methodology employed. Rather, it seems that the real problem lies in the data. Specifically, the data sourced from the oft-quoted "Food-Related Illness and Death in the United States" study conducted in 1999 by Paul S. Mead. The use of data from the Mead study unnecessarily discounts the results of Scharff's paper. Indeed, if Scharff were to have published the same study using numbers of actual confirmed, reported illnesses, the results would have shown dollar costs per illness that were just as impressive, yet the results would leave far fewer lingering questions as to accuracy.

The 1999 Mead study is perhaps best known for one sentence: "We estimate that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year." (See http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm). This sentence is widely quoted in articles that discuss foodborne illness. Heck, I have even used the sentence in my own writings on the topic as a means to show the widespread nature of foodborne illness. Interestingly, some of the numbers from the text of the study are even higher than the above-quoted figures, notably the death estimate, which the study estimates is actually 5,194 persons per year.

Critics of the Mead study, however, point out that roughly 3,400, or 65 percent, of the approximately 5,200 estimated deaths were attributed to "unknown foodborne agents." Therein lies the twist. As detailed by Paul D. Frenzen, the problem with the Mead study is that the estimates of deaths attributed unknown foodborne agents were generated from hospital records and death certificates that stated a cause of death as "gastroenteritis of unknown cause." But, as Frenzen points out, "the death estimate consequently omitted deaths from unknown foodborne agents that do not cause gastroenteritis and likely overstated the number of deaths from agents that cause gastroenteritis." (See http://www.cdc.gov/ncidod/eid/vol10no9/03-0403.htm).

The problems with the Mead study go beyond the death cases discussed in the Frenzen critique. The Mead study employed the same symptom-based data to determine non-death cases of foodborne illness caused by unknown foodborne agents. All said, the study attributed 62 million cases of foodborne illness to unknown agents, or fully 82 percent of the total estimate of 76 million foodborne illness cases per year. Given the imprecise means that were used to obtain the estimates of illnesses attributed to unknown agents, such a large percentage discounts the credibility of the entire data-set.

All of this is not to say that Mead was trying to hide the ball. In the last paragraph of his study, Mead points out that "further refinements of foodborne disease estimates will require continued and improved active surveillance." (See http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm). Nonetheless, this caveat is often ignored by those who quote Mead's figures.

The shortcomings of data from the Mead study became even more amplified in the context of the recent Scharff study. The Scharff study directly applied the Mead data for illnesses caused by unknown agents to its own cost calculations, simply adjusting the numbers for population growth. As a result, Scharff attributed 67 million cases of foodborne illness to unknown agents, resulting in an annual cost to United States residents of almost $96 billion. This accounts for 63 percent of the total estimated annual cost of $152 billion. (For those of you who are wondering why the figure does not account for 82 percent of the total cost, Scharff weighted the various dollar costs according to the varying cost of treatment for each pathogen studied.)

As a result of applying the Mead data for illnesses caused by unknown foodborne agents, Scharff discounted the credibility of his recent study. That is not to say that his figures are inaccurate. As far as anyone knows, the dollar figures he has assigned to foodborne illness might coincidentally be quite precise. The problem, however, is one of reliability. Followers of Scharff's study cannot rely on the accuracy of the results, because as Frenzen pointed out, "the methods used by the Mead study have several shortcomings." (See http://www.cdc.gov/ncidod/eid/vol10no9/03-0403.htm).

All of this is not meant to imply that Scharff's numbers are inflated. Rather, as emphasized by Frenzen, because of the methodology used to collect the data, the number of foodborne illness victims exhibiting gastroenteritis may be overinflated, and the victims of foodborne illnesses that do not exhibit gastroenteritis are unaccounted for. For all we know, Mead's figures may in fact be underinflated. At this point, however, there is simply not enough data to support a reliable conclusion.

Like many others who work in the world of foodborne illness, I am personally very interested in the annual costs associated with victims of foodborne infections. The Scharff study followed the right approached. It sought to account for the totality of costs, ranging from quality of life losses to the cost of lost life expectancy. Indeed, as those with a bit of economic knowledge can attest, the societal costs of severe illnesses are much greater than simply the sum of all medical bills. Nonetheless, correct methodology can only take one so far when the majority of the data used to generate the final results is based on speculative assumptions.

The Scharff study would have proved more useful if it would have focused on individual average costs incurred by victims of various foodborne illnesses. This would have shown the severe economic impact that sufferers of foodborne illness endure, yet would have alleviated the problems associated with estimating aggregate costs based on the results of the Mead study. Perhaps a figure like $152 billion generates a greater wow factor, but realistic figures of actual costs would generate a more lasting impact.

Living with ESRD

ccaywood@marlerclark.com (Colin Caywood) — Fri, 05 Mar 2010 01:59:03 -0800

What It Is Like To Live With End Stage Renal Disease (ESRD)?

In honor of March's official designation as National Kidney Month, fellow Food Safety News contributing writer Dave Babcock recently published an article, National Kidney Month Kicks Off. In his article, Babcock discusses the connection between long-term kidney health and food safety, a connection which most commonly flows from the development of hemolytic uremic syndrome (HUS) caused by toxins from foodborne bacteria like shiga toxin-producing Escherichia coli (E. coli).

As anyone who has been forced to suffer through ESRD can attest, the physical and mental effects it can cause are devastating.

While it is true that various treatment options presently exist, none of those options are especially desirable. The biggest and most obvious decision for a person diagnosed with ESRD to make is whether to sustain on dialysis for as long as possible, or seek out a kidney transplant, likely enduring dialysis anyway during the waiting period.

If given the choice, most people with ESRD will opt for a kidney transplant. There is evidence that a transplant can increase a person's life expectancy up to three times longer than dialysis alone. It can also have a much less invasive effect on a person's day-to-day life when compared with the requirements of dialysis. Unfortunately, the wait-time for a donor kidney is often a year minimum, but usually longer depending on a variety of factors.

One such wait time factor is blood type. For example, a person with a rare blood type O will have the longest wait period, usually three to four years. Because a patient with blood type O has antibodies against blood types A, B, and AB, it severely limits the donor pool from which a kidney may be harvested. If the patient is fortunate, perhaps a deceased or living close relative, such as a parent or sibling over the age of 18 and who is compatible with the patient, will be able to donate a kidney. Regardless, while awaiting a donor, an ESRD patient must undergo dialysis treatment just to survive until the transplant operation can be performed.

Assuming the patient survives the transplant procedure, they can then look forward to a lifetime of immunosuppressive medications, necessary to prevent their body from rejecting the transplanted kidney. The artificial suppression of the immune system is--as nearly anyone can surmise--fraught with considerable side effects.

Commonly used immunosuppresants include cyclosporine, tacrolimus, meclophenalate, imuran, and corticosteroids. Cyclosporine and tacrolimus have side effects that include increased hair growth and gum hypertrophy, as well as, ironically, damage to the kidney. Meclophenalate and imuran are known to cause low white blood cell count and increased susceptibility to infection. Corticosteroids can produce the undesirable Cushing's syndrome (fatty deposits around the facial cheeks, as well as on the abdomen and back), weight gain, emotional instability, cataracts, decreased growth, softening of the bones and bone pain, hypertension, acne, and difficulty in controlling glucose levels.

Immunosuppressants, like those described above, are necessary for organ transplant recipients. They reduce the body's immune response, thereby preserving the useful life of the transplanted kidney which the body would otherwise recognize as foreign and dangerous. If this occurs, it sets off a chain of events that culminate in the body's rejection of the kidney. But because a healthy and timely immune system response is the body's critical and natural defense against illness, immunosuppression therapy necessarily leads to a lifetime of heightened susceptibility to serious infection, accelerated hardening of the arteries, cancer, and chronic kidney rejection.

Assuming the transplanted kidney is received by the patient without complication, no transplant lasts forever. The patient's transplanted kidney can be expected to last about 15 years if it comes from a living donor, or about 10 years if it comes from a cadaver. Of course, the younger the patient develops ESRD, the higher the probability that a second, or even third, kidney transplant will be required during their lifetime. As each transplant reaches the end of its useful life, the patient will fall back into the cycle of ESRD, dialysis, an increase in kidney-related medical problems and then--assuming another kidney transplant is possible--recovery from transplantation.

Either decision the patient makes--transplant or dialysis--will involve dialysis treatments regardless. As with a transplant, the patient's quality of life is guaranteed to suffer markedly. There are generally two modes of dialysis an ESRD patient may undergo: peritoneal dialysis or hemodialysis.

Peritoneal dialysis has been a major physical therapeutic method of therapy for ESRD for several years. Continuous Ambulatory Peritoneal Dialysis (CAPD) and automated peritoneal dialysis, also called Continuous Cycling Peritoneal Dialysis (CCPD), are the most common form of dialysis therapy used in children. In this form of dialysis, a catheter is placed in the area around the stomach. Dialysate (a chemical bath that draws fluids and toxins out of the bloodstream) is placed into the abdomen and changed four to six times a day. While children must often go to a medical treatment facility, adults can usually perform CAPD/CCPD at home.

The known compilations of peritoneal dialysis include peritonitis (infection of the fluid), which can be a major risk. Symptoms of peritonitis include fever, excruciating abdominal pain with movement, nausea, and vomiting. If left untreated, it usually results in death.

The other common dialysis method to treat ESRD is hemodialysis. During hemodialysis, blood in taken out of the body by a catheter or fistula, and circulated in a machine that simulates the kidney's natural cleansing process, removing harmful toxins and excess fluid from the blood. While the hemodialysis process itself does not physically hurt, patients usually experience nausea and abdominal cramps as excess fluid is pulled from the body, along with fluctuations in blood pressure and heart rate. Hemodialysis is generally performed three times a week, and takes a major time commitment--three to four hours per session is the average.

Beyond the transplant and dialysis complications, bone disease is nearly universal in patients with ESRD. As a result, patients will be prone to develop bone pain, skeletal deformities and abnormal shaped bones, and have a propensity for fractures with minor trauma. Treatment of the bone disease associated with ESRD includes careful control of the patient's serum phosphorous and calcium levels with stringent dietary restrictions, calcium supplements, phosphorus binders, and various other bone disease-fighting medications.

The last major common complication of ESRD worth mentioning is anemia. Anemia can be treated with a shot of erythropoietin given under the skin one to three times a week, or once every few weeks with a longer acting dose. Erythropoietin is a hormone normally produced by the kidney that promotes the formation of red blood cells in the bone marrow. In patients suffering from ESRD, this hormone ceases to be produced, thus anemia results. Left untreated, anemia can cause severe fatigue, nerve damage, mental impairment, heart problems, and death.

Given the gloom and doom of this article, it is important to remember that a person's diagnosis with ESRD is a not a death sentence. But just because a person is fortunate enough to survive a serious shiga toxin-producing E. coli infection and HUS--often the result of foodborne contamination--kidney damage sufficient to result in ESRD will continue to affect their life long after the E. coli infection has passed. The vast complications of ESRD are incredibly serious, often painful, and certain to drastically reduce a person's overall quality of life.

National Kidney Month Kicks Off

dbabcock@marlerclark.com (Dave Babcock) — Tue, 02 Mar 2010 01:59:03 -0800

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which makes up part of the National Institutes of Health (NIH), has issued a press release recognizing World Kidney Day on March 11. The awareness-raising day occurs during National Kidney Month.

According to NIDDK, "Chronic kidney disease affects approximately 23 million adults in the U.S. and is a major public health challenge. In 2007, almost 111,000 people in the U.S. began treatment for the most advanced stage of the disease, kidney failure. That year, treatment costs paid by Medicare totaled $23.9 billion -- 5.8 percent of the Medicare budget."

Kidney Health and Food Safety--HUS and E. coli O157:H7

There is a close connection between kidney health and food safety. Hemolytic uremic syndrome (HUS), a potentially fatal complication of E. coli O157:H7 infection, is the most common cause of kidney failure in children.[1] HUS is a frequent cause of long-term kidney injury in both children and adults.

Hemolytic uremic syndrome develops when the toxins from bacteria such as E. coli O157:H7, known as Shiga-like toxins (SLT), enter the bloodstream through the inflamed bowel wall.[2] SLT attach to receptors on the inside surface of blood vessel cells and initiate a chemical cascade that results in the formation of tiny thrombi (blood clots) within these vessels.[3] Several organs appear more susceptible to these clots, including the kidney. Thus, when fully expressed, HUS presents with the triad of hemolytic anemia (destruction of red blood cells), thrombocytopenia (low platelet count), and renal failure (loss of kidney function).[4]

There is no cure or effective treatment for HUS.[5] Approximately half of the children who suffer HUS require dialysis to survive the acute stage of the illness. Those who do survive almost invariably suffer irreversible damage to the kidneys. The damage sustained in the short term then places the patient at risk for long-term kidney complications, including end stage renal disease (ESRD). Five percent or more of those who survive have long-term kidney impairment.[6]

Hyperfiltration Injury

"Hyperfiltration injury" is a term used to describe chronic, progressive damage in kidneys that have already sustained significant damage during an HUS illness, resulting in the destruction of a substantial percentage of nephrons. Nephrons are the functional units of the kidney and are comprised of glomeruli connected to kidney tubules.

Where hyperfiltration injury has occurred, the remaining healthy glomeruli attempt to adapt to their reduced number by enlarging (hypertrophy) and by hyper-filtrating. In other words, the remaining glomeruli work extra hard in an attempt to meet the needs of the body. For a time, they are usually able to compensate. The glomeruli, however, are being over-worked. This overworking of glomeruli is manifested by the spillage of protein (albumin) in the urine. This phenomenon is called proteinuria.

Over time, the hyperfiltration injury causes progressive loss of the remaining glomeruli due to the formation of scar tissue, or fibrosis. Once the remaining functional nephron population drops below 10 percent, the person's survival requires initiation of "renal replacement therapy".

There are some medications that can help slow the need for renal replacement therapy. The use of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) is usually helpful in slowing the fibrotic process, but no known treatment can stop it. ESRD, also known as stage 5 kidney disease, eventually occurs.

End Stage Renal Disease

Common problems associated with the development of ESRD include:

Reduced ability to excrete waste products and maintaining fluid and electrolyte balance: As kidney function declines, waste products will accumulate. The patient will experience uremic toxicity characterized by weakness, loss of appetite, nausea, and vomiting, and if not treated with dialysis, seizures, coma and death.

Accumulation of body acid: The patient will need to take a base such as sodium bicarbonate to neutralize remaining body acid. Failure to do so results in poor appetite and weakened bones.

Anemia: The patient may require hormone injections that would begin no later than the start of dialysis, and probably sooner.

Loss of bone density: The patient is at high risk for bone pain and fractures.

High blood pressure: High blood pressure afflicts the majority of kidney failure patients. Failure to maintain normal blood pressure increases the risk of heart failure, heart attack and stroke.

Once ESRD is reached there are two survival options: long-term dialysis treatment or a kidney transplant. Dialysis is a treatment designed to replace what damaged kidneys can no longer do. Treatments are usually 3-4 hours three times a week. Receiving regular dialysis presents several challenges.

At some point, kidney transplant may be preferable to dialysis or become necessary for survival. The wait for a kidney is months to years, depending on the availability of a donor and the recipient's blood type. Since all kidneys except those from an identical twin are recognized as "foreign" by the recipient's immune system, it will be necessary, for the rest of a transplant recipient's life, to use immunosuppressive medications to reduce the risk of rejection. Common complications of renal transplant include the following:

Acute rejection of the transplanted kidney. This often requires a biopsy of the graft, and the use of very powerful medications (probably requiring hospital stays).

Infections (viral, fungal and bacterial) that can be life threatening.

Cancer due to the Epstein- Barr virus, and goes by the term of Post Transplant Lymphoproliferative Disease (PTLD).

Osteopenia, an additional post-transplant risk is osteopenia (loss of bone calcium).

Premature coronary artery disease--coronary artery disease (including myocardial infarction) is the most common cause of death in the transplant population.

There is no known treatment to stop the progression of HUS--at either the acute stage or long-term. Likewise, while not all those infected develop HUS, there is no way of preventing the development of HUS in a person infected with E. coli O157:H7. As a result, there is only one avenue to reducing the impact of E. coli O157:H7 on kidney health--preventing food from becoming contaminated with E. coli O157:H7 in the first place.

References

1. Chinyu Su, MD & Lawrence J. Brandt, MD, Escherichia coli O157:H7 Infection in Humans, 123 Annals Intern. Med. (Issue 9), 698-707.

2. Amit X. Garg, MD, MA, et al. Long-term Renal Prognosis of Diarrhea-Associated Hemolytic Uremic Syndrome: A Systematic Review, Meta-Analysis, and Meta-regression, 290 JAMA (No. 10) 1360, 1360 (Sept. 10, 2003).

3. Richard L. Siegler, MD, The Hemolytic Uremic Syndrome, 42 Ped. Nephrology, 1505 (Dec. 1995), at 1509-11 (describing what Dr. Siegler refers to as the "pathogenic cascade" that results in the progression from colitis to HUS).

4. Nasia Safdar, MD, et al. Risk of Hemolytic Uremic Syndrome After Treatment of Escherichia coli O157:H7 Enteritis: A Meta-analysis, 288 JAMA (No. 8) 996, 996 (Aug. 28, 2002). at 1360. See also Su & Brandt, at 700.

5. Id., at 996. See also Siegler, supra note 3, at 1379. ("There are no treatments of proven value, and care during the acute phase of the illness, which is merely supportive, has not changed substantially during the past 30 years.")

6. Safdar, supra note 4, at 996 (going on to conclude that administration of antibiotics to children with E. coli O157:H7 appeared to put them at higher risk for developing HUS).

The American Diet: A Sweet Way to Die

bclark@marlerclark.com (Bruce Clark) — Fri, 26 Feb 2010 01:59:04 -0800

I am often asked what foods I avoid because they may carry a risk of contamination with pathogenic organisms. I have a very short list of foods to avoid on principle based on concerns about the potential for bacterial adulteration. But I am increasingly concerned about the general quality of the American diet as a cause of chronic health problems, including increasing rates of heart disease, obesity, and type 2 diabetes. And while bacterial contamination of food in this country remains a large problem, in terms of disease burden it is dwarfed by the effects of unadulterated foods we eat every day.

Most of us are aware that the number one killer of adult Americans is heart disease. Cardiovascular heart disease is driven in significant part by what we eat. In very simple terms, cardiovascular disease involves injury to the endothelial cells that line coronary arteries and leads to formation of fatty streaks which contain lipoproteins and other cellular debris. Fat deposition also provokes an inflammatory reaction in the arterial walls which promotes further cellular deposition.[1] Rupture of these "plaques" is a leading cause of sudden coronary artery obstruction or heart attack and stroke. In addition to high levels of cardiovascular heart disease, Americans also experience high levels of obesity, hypertension, and diabetes which are interrelated and all share roots in the American diet. Indeed, current research indicates that obesity, glucose intolerance, and hypertension in childhood are strongly associated with increased rates of premature death from endogenous causes in adulthood.[2]

Researchers have spent decades trying to tease out those factors that increase our risk of heart disease and related disorders. For instance, The Framingham Heart Study[3] is the largest longitudinal study of cardiovascular heart disease ever conducted. Starting with a cohort of just over 5,200 adult men and women in 1948 who lived in Framingham, Massachusetts, the Study continues to follow the now multi-generational cohort to identify, among other things, risk factors for cardiovascular heart disease. Among the risk factors Framingham has traced are levels of lipoproteins, combinations of proteins, and lipids that transport fat in the bloodstream. As the Framingham study makes clear, both low density liproproteins (LDL a/k/a "bad"[4] cholesterol) and high density lipoproteins (HDL a/k/a "good" cholesterol) play important roles in coronary artery disease.

Perhaps because we've heard so much about cholesterol, Americans have long been focused on dietary fat as a risk for cardiovascular heart disease. But what if there is an aspect of the American diet that poses a host of serious health effects, including cardiovascular heart disease, more deleterious than dietary fat (or additives, chemicals, or anything else on your food worry list)?

In 1982 the USDA recommended that Americans reduce their intake of dietary fat by 10 percent. This recommendation was based in significant part on an epidemiological study by famed University of Minnesota epidemiologist Ancel Keys, called the Seven Countries Study, that showed as dietary fat intake increased so did the incidence of heart disease.[5] And while we have, in fact, consumed less fat since, we are steadily consuming more calories and the rate of cardiovascular heart disease has not decreased. Why? An important part of the answer appears to be sugar, and specifically one type of sugar: fructose.   Table sugar, sucrose, is about half glucose and half fructose. And while there are a variety of dietary sources of fructose, the biggest source in the American diet is high fructose corn syrup which sometimes has a higher concentration of fructose than does sucrose.[6]

High fructose corn syrup is not natural. It was invented in Japan in 1966 and made its way into the American diet beginning in the mid-1970s on the heels of sugar price supports enacted during the Nixon administration.   High fructose corn syrup has two attributes that make it appealing to food manufacturers: it is cheaper than sucrose and it easily handled and transported because it is a liquid. Given its prevalence today in processed foods one could conclude that everything tastes a little better with some high fructose corn syrup in it.[7]

Obese people do not want to be obese. Americans have not consciously chosen to become fat en masse over the past few decades. Something has been going on with the American diet to produce an increasing number of obese adults, teens, and yes, babies.[8] In an article published in the journal Obesity in 2006, researchers found children 6 years old and younger are 59 percent more likely to be overweight than they were in the 1980s. Meanwhile, babies up to 6 months old are 74 percent more likely to be overweight.[9] As we get fatter we also continue to suffer very high rates of cardiovascular heart disease and diabetes.

One of things that is clearly going on is that Americans eat more of most everything and much, much more sugar than we did even a few decades ago. Annual consumption of total sugars increased about 25 pounds from 1970 to 2000 and not coincidentally our consumption of corn sweeteners (mainly high fructose corn syrup) nearly tripled ruing that same period.[10] (Click to enlarge chart)

Whatever else the USDA does, it collects a lot of data on what we eat through the Agricultural Research Service's National Health and Nutrition Examination Survey (NHANES)[11] NHANES has documented the changing American diet in detail over the past decades including our increasing consumption of sugar.

Our bodies literally run on sugar, glucose that is. Glucose can be used by every cell in the body. It is stored in the liver in the form of glycogen. Fructose is metabolized by the liver very differently than glucose. Unlike glucose only the liver can metabolize fructose which means all the fructose you eat goes straight to your liver where a number of distinctly deleterious actions occur. For instance, fructose metabolism in the liver increases uric acid (which causes gout) and also inhibits the enzyme involved in nitric oxide production which is a vasodilator--something that keeps our blood vessels open and helps lower blood pressure. Indeed, a high fructose diet is a recipe for hypertension.[12] Fructose metabolism has been implicated in hyperinsulinemia--a heightened insulin response which can interfere with the hormone leptin that tells us when we have had enough to eat.[13] Instead of promoting satiety, fructose consumption may actually increase food intake and obesity.[14] A high fructose diet is also associated with increased production of very low density liproproteins (VLDL)[15] high levels of which increase the risk for cardiovascular heart disease.[16]

The consumption of high levels of fructose is the subject of much ongoing research which point to a role for the overconsumption of fructose in the metabolic syndrome. The metabolic syndrome is a cluster of conditions--hypertension, elevated insulin levels, excess body fat around the waist, abnormal cholesterol levels, and dislipidemia[17]--that occur together, increasing your risk of heart disease, stroke, and diabetes. Fructose appears to be highly lipogenic (causing fat formation) and contributes to tissue insulin insensitivity, metabolic defects, and the development of a prediabetic state.[18] If this sounds like a big deal, it ought to since we're talking about the leading cause of death in the U.S. and conditions that dominate the economics of our health care system. In one study medical students were fed either glucose or fructose to see how it affected de novo lipogenesis (new fat formation). The results are illustrated in the chart below.[19] It indicates that a high sugar diet is really a high fat diet.

The effects of a high sugar diet are compounded by the absence of fiber in what most of America eats. If you eat highly processed foods, including fast food, you are consuming almost no fiber. There are lots of claims about what fiber can and cannot do, but the consumption of fiber may play a role in fat formation by reducing the rate of intestinal carbohydrate absorption and reducing the insulin response; speeding transit of the contents of the intestine to the ileum which triggers satiety; and, inhibiting absorption of some free fatty acids.[20]

It is no surprise that corn sweeteners are now the dominant form of sugar given the ubiquity of all things corn in the American diet. There is little reason to believe that the FDA will take action to protect Americans from their overconsumption of corn sweeteners since it has failed to meaningfully regulate high fructose corn syrup.   But the evidence that too much fructose is dangerous is hard to dismiss. A recent study on human subjects, in which two groups were given either glucose- or fructose-sweetened beverages, suggests differences in the way these sugars affected fat deposition: "...fructose and glucose have differential effects on regional adipose distribution. We believe that these results are novel and warrant further investigation."[21] This study also found an association between fructose consumption and decreased insulin sensitivity, one of the pathways to diabetes. A diet that leads to chronic health problems such as diabetes also makes one more vulnerable to infection, including foodborne pathogens.[22] Likewise, it appears that obesity itself may alter the immune response and increase vulnerability to common infections.[23]

What does this all mean? Consider this comment about the future impact of the growing waistlines of adolescent Americans from a study that projected the annual increase in the incidence of cardiovascular heart disease secondary to obesity: "Although projections 25 or more years into the future are subject to innumerable uncertainties, extrapolation from current data suggests that adolescent overweight will increase rates of cardiovascular heart disease among future young and middle-aged adults, resulting in substantial morbidity and mortality"[24] (emphasis added). Young Americans may well be eating their way to sugary graves. Current research suggests that the single most dangerous thing in the American diet may well be too much sugar.[25] And whether you are young or old, that is food for thought indeed.

References:

1. http://www.texasheart.org/hic/topics/cond/vulplaq.cfm.

2. Franks PW et al. Childhood Obesity, Other Cardiovascular Risk Factors, and Premature Death. NEJM, vol. 362:485-493 (February 11, 2010).

3. http://www.framinghamheartstudy.org/.

4. Size and density matters with cholesterol. Small, dense cholesterol particles are more likely to penetrate arterial walls where they help build plagues. Not all LDL is the same however. Some LDL, known as pattern A, is relatively larger and less dense and is considered benign in terms of CVD risk.   And certainly some component of cholesterol make up in any individual is driven by genetics.

5. Verschuren WM et al. Serum total cholesterol and long-term coronary heart disease mortality in different cultures. Twenty-five-year follow-up of the seven countries study. JAMA. 1995 Jul 12;274(2):131-6. This review, and many other commentaries, makes clear that the association between high dietary fat intake and Cardiovascular heart disease is dependent on more than just fat. Indeed, Americans' declining fat consumption and associated high rates of cardiovascular heart disease have prodded research increasingly towards carbohydrates as a key contributing factor to a variety of maladies.

6. High fructose corn syrup contains 42 to 55 percent fructose; 55 percent high fructose corn syrup is typically used in soft drinks. It is not high fructose corn syrup per se that constitutes the problem of increased sugar and caloric consumption in the American diet. But high fructose corn syrup is the form in which we get most of our fructose, and too much fructose is a problem. You may have noticed that the Corn Refiners Association is running an extensive TV ad campaign that seeks to convey the "naturalness" of high fructose corn syrup. See www.sweetsurprise.com. Of course, high fructose corn syrup does not occur in nature.   Fructose is a natural component of fruit, but it would be very hard to over consume fructose solely by eating fruit; fruit juice, on the other hand, is a significant source of fructose for many American children.

7. A review of ingredient labels of "low fat" food items typically reveals that the fat has been replaced by high fructose corn syrup.

8. Kim J et al. Trends in Overweight from 1980 through 2001 among Preschool-Aged Children Enrolled in a Health Maintenance Organization. OBESITY (2006) 14, 1107-1112; see also, Gillman, MW, The first months of life: a critical period for development of obesity. American Journal of Clinical Nutrition, Vol. 87, No. 6, 1587-1589, June 2008.

9. Kim J, supra.

10. USDA Agricultural Fact Book 2001-2002, Chapter 2 Profiling Food Consumption in America, table 2-6.

11. http://www.ars.usda.gov/Services/docs.htm?docid=13793.

12. Nguyen S, et al. Sugar-Sweetened Beverages, Serum Uric Acid, and Blood Pressure in Adolescents. J PEDIATRICS, vol. 154, Issue 6:783-784, June 2009. See also, Johnson RJ, et al, Potential role of sugar (fructose) in the epidemic of hypertension, obesity and the metabolic syndrome, diabetes, kidney disease, and cardiovascular disease. AM J CLIN NUTRI, Vol. 86, No. 4, 899-906, October 2007. See also, Jalal DI et al, Increased Fructose Intake Is Independently Associated with Elevated Blood Pressure. Findings from the National Health and Nutrition Examination Survey (2003-2006). J AM SOC NEPHROL, 20:9A November 2009.

13. Lustig RH. Childhood obesity: behavioral aberration or biochemical drive? Reinterpreting the First Law of Thermodynamics. Nature Clinical Practice Endocrinology & Metabolism, 2:447-458 (2006).

14. Lane MD, Cha SH. Effect of glucose and fructose on food intake via malonyl-CoA signaling in the brain. Biochem Biophys Res Commun. 24;382(1):1-5 (April 2009). Epub 2009 Mar 3. But see, Moran, TH. Fructose and satiety. J Nutr. 2009 Jun;139(6):1253S-1256S ("On balance, the case for fructose being less satiating than glucose or high fructose corn syrup being less satiating than sucrose is not compelling").

15. Chong MFF. Mechanisms for the acute effect of fructose on postprandial lipemia. AM J CLINICAL NUTRI, Vol. 85, No. 6, 1511-1520, June 2007.

16. Liu J. Non-high-density lipoprotein and very-low-density lipoprotein cholesterol and their risk predictive values in coronary heart disease. AM J CARDIOL. 15;98(10):1363-8 (Nov 2006.

17. Dyslipidemia is the dysfunction of lipoprotein metabolism involving elevated cholesterol, high triglycerides, elevated levels of LDL and low HDL. It is associated with an increased risk of coronary heart disease.

18. Miller A. Dietary Fructose and the Metabolic Syndrome. CURR OPIN GASTROENTEROL, 24(2):204-9, March 2008.

19. Hellerstein et al. Regulation of de novo lipogenesis in humans. ANN REV NUTR 16:523, 1996.

20. See, e.g., Mathern JF, et al. Effect of fenugreek fiber on satiety, blood glucose and insulin response and energy intake in obese subjects. PHYTOTHER RES., 23(11):1543-8, November 2009.

21. Stanhope KL, et al. Consuming fructose-sweetened, not glucose-sweetened, beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans. J CLIN INVEST.; 119(5): 1322-1334 (May 2009).

22. http://www.mayoclinic.com/health/food-poisoning/DS00981/DSECTION=risk-factors

23. Falagas ME, Obesity and Infection. LANCET INFECT DIS., 6(7):438-46 (July 2006).

24. Bibbons-Domingo K, et al. Adolescent Overweight and Future Adult Coronary Heart Disease. NEJM, Volume 357:2371-2379, December 2007.

25. It is important to note that many studies, as well as common experience, have found a significant role for lower levels of physical activity in Americans' growing waistlines. As with most complex health problems no single factor can be blamed for all effects, but the focus of this article is on caloric intake not expenditure.

On Cooking Burgers: Out, damned E. coli! Out!

dstearns@marlerclark.com (Denis Stearns) — Wed, 24 Feb 2010 01:59:03 -0800

For decades, the meat industry has insisted that pathogens like E. coli O157:H7 are inherent to raw meat, that there is no way for the manufacturing process to eliminate the possible presence of pathogens, and that, as a result, consumers bear ultimate responsibility for making meat safe to eat by cooking it sufficiently to kill all pathogens that may be present. From this position, the meat industry has spun the tautological assertion that a consumer who is injured by eating, for example, a hamburger that is contaminated with E. coli O157:H7 was not injured as a result of contamination, but, instead, as a result of undercooking. In other words, any hamburger that is not cooked in a manner such that the meat is essentially pasteurized is, by definition, not only undercooked, but negligently so. And so, voila, it is the consumer who must be at fault for being injured, not the ground beef manufacturer, because, in the words of J. Patrick Boyle, President and CEO of the American Meat Institute (AMI), "We are selling a raw product,...and raw products by their nature may contain harmful bacteria. That's why we are committed to providing consumers the information that they need to handle and cook ground beef safely."[1]

Recently, however, a seemingly heretical voice has suggested that perhaps some meat products--pre-made frozen hamburger patties, to be exact--pose a risk to consumers of such a greater kind and degree that the meat industry must take extra steps to make this commonly-purchased product much safer than it currently is. The source of this heresy was James Marsden, PhD, writing in the MeatingPlace.com blog, a forum that more often than not adheres to the meat industry "party-line" (like the over-the-top Yvonne Vizzier Thaxton who on a regular basis causes me to cough-spit coffee onto my computer screen by offering opinions so ludicrously pro-industry (and illogical) that that not even the AMI at its most strident can compare[2]).

In his excellent opinion piece, titled "Retail Frozen Ground Beef Patties and Risks of E. coli O157:H7," Dr. Marsden asserts that: "It's time to recognize that retail frozen ground beef patties pose an increased risk to consumers and take steps to reduce that risk."[3] Supporting this assertion, Dr. Marsden points out that frozen patties have "been implicated in an inordinate number of infection-cases, outbreaks, and recalls," the vast majority of which have not involved a fast food restaurant. The significant drop in the number of restaurant-related hamburger E. coli outbreak happened because, after the 1993 Jack in the Box outbreak, chain fast food restaurants took "steps to assure the safety of frozen beef patties, including raw material and finished product testing, the implementation of validated cooking processes that fully inactivate E. coli O157:H7 and process control measures that guarantee proper cooking every time." In contrast, the reason that there are still so many outbreaks linked to hamburgers is because consumers are ill-equipped to cook frozen ground beef patties in a way that makes them consistently safe to eat. And this is because, according to Dr. Marsden, "frozen patties are inherently difficult to cook uniformly and sufficiently to control pathogens."

Such heresy! I think I can almost hear J. Patrick Boyle screaming for Dr. Marsden's excommunication from all dealings with the meat industry. How dare someone suggest that cooking by the average consumer is not the safety-panacea that the meat industry has long insisted it is. How dare someone suggest that a consumer who is being reasonably careful in the cooking of a frozen ground beef patty on his or her backyard grill might not, by definition, be negligent simply because a few E. coli O157:H7 happen to survive the cooking process, which is something that can and does happen with even the most cautious of cooks. Indeed, Dr. Marsden doubles-down on his heresy by going on to make the same point that I have been making for years, in representing injured consumers, and in my writings and speeches:

it is not realistic to expect that all consumers will apply perfect cooking methods when preparing frozen ground beef patties. The risk of E. coli contamination in these products has to be reduced upstream. (emphasis added)

And that is really what it comes down to, in my view. Although the meat industry expects all consumers to be perfect in the cooking of every single hamburger, every single time, it wants to be excused from all responsibility for its contamination of meat with deadly pathogens.

As I have said on numerous occasions before, the reality of meat production in the United States is that it is done as quickly and as cheaply as possible. All possible care is not used in the slaughter and processing of meat, and that is why it gets contaminated with pathogens. Arguing consumer responsibility, while suggesting that eliminating E. coli O157:H7 from ground beef by cooking is as easy as snapping your fingers, has long been the meat industry's attempt to divert attention from its own culpability. Like the "Wizard of Oz" insisting that we "pay no attention to the man behind the curtain," the meat industry wants the consuming public to pay no attention to the reality of how meat--and especially ground beef--is manufactured in this country. I mean, how many consumers knew a year ago that frozen ground beef patties, like the one that nearly killed Stephanie Smith, among others, contained ammonia-treated "fatty trimmings the industry once relegated to pet food and cooking oil" as a primary ingredient.[4]

Of course, consumers have been more than a little complicit in the success of the meat industry's diversionary tactics with their tendency to demand safer meat, but still purchase the cheapest hamburger patties available. This consumer behavior rewards the companies that cut costs the most, which is to say, cut corners the most. Ammonia-treated fatty trimmings are not used because ammonia-treated meat is a superior ingredient; they are used because it is a cheaper ingredient. As such, it is not that raw ground beef is inevitably contaminated with pathogens; it is that cheap ground beef is inevitably contaminated with pathogens. And packages of mass-produced frozen ground beef patties, like those sold under the American Chef's Selection brand at Walmart, are about as cheap a ground beef product as you can find on the market today.

That is why Dr. Marsden's point--and the fact that he announced it on a meat-industry sponsored website--is so important. Although it is difficult and costly to prevent contamination in a meat processing plant, it is just as difficult to perfectly cook a frozen ground beef patty every single time it is done. Moreover, the cost of the consumer not being perfect is very often the serious injury or death of a loved one.

And so, ask yourself: Which cost is too high to pay? Is paying 25 cents more per pound for a box of frozen hamburger patties too expensive when compared to the cost of losing a son or daughter, or a mother or father, to a horrifyingly painful E. coli O157:H7 infection? Consider also, that when the USDA implemented the HACCP/Pathogen Reduction Rule in 1996, a subsequent economic analysis estimated that compliance with the regulations raised a plant's costs of production less than one cent per pound.[5] Keep in mind too that a primary rationale of the HACCP/Pathogen Reduction Rule is that E. coli O157:H7 be reduced to an "undetectable level." This so-called zero-tolerance policy is based on the irrefutable fact that if the "presence [of E. coli O157:H7] can be prevented, no amount of temperature abuse, mishandling, or undercooking can lead to foodborne illness." See HACCP Final Rule, 62 Fed. Reg. at 38,962. In other words, when a pathogen is not present in ground beef, a consumer need not be perfect--or even terribly careful--in its preparation and cooking.

For these and other reasons, the USDA-FSIS has more than once rejected the meat industry's suggestion that consumers should be primarily responsible for making ground beef safe to eat through cooking. And, interestingly, the Agency's rejection of the meat industry's "blame-the-consumer" approach was done using language remarkably similar to that used by Dr. Marsden in his opinion piece. Over ten years ago, on February 11, 2000, FSIS stated:

Several industry commentators stated that consumers should assume more responsibility for their safety and expressed the need for consumer awareness programs regarding the importance of cooking beef products thoroughly.

Industry can reduce or eliminate risk associated with [E. coli] O157:H7 through various controls and interventions . . . that can be incorporated into HACCP systems. Because industry has the means to reduce or eliminate the hazard, consumers should not be expected to assume all the responsibility for preventing foodborne illness associated with [E. coli] O157:H7.[6]

Noting that the USDA in the above quoted statement asserted that consumers should not be expected to assume all the responsibility for preventing foodborne illness, let me then concede that I believe that consumers do bear some responsibility for preventing foodborne illness. There are plainly situations in which egregious food-handling errors might provide the basis for arguing, as both a legal and practical matter, that the manufacturer or the contaminated meat is not solely to blame for the resulting illness. This assumes, however, that the consumer has the information and skills necessary for them to act in a reasonably safe manner. As such, Dr. Marsden makes a similar point in favor of consumer education when he states that: "If all consumers were educated about the risks associated with frozen beef patties, and took the same steps that have been successful in restaurant preparation, the problem would be solved."

The problem here is that, despite the suggestions of the USDA and the meat industry to the contrary, consumers mostly lack the skills and information necessary for the reasonably safe preparation of ground beef, let alone the perfectly safe preparation of frozen ground beef patties. One reason for this is the meat industry's decade-long effort to keep effective warning labels off of meat products. In 1971, the American Public Health Association (APHA) sued the USDA in an attempt to force the USDA to place a warning label with cooking instructions on all packages of raw meat and poultry. Among other things, the APHA argued that the USDA "stamp-of-approval" misled the public into thinking that the meat was free of pathogens, like Salmonella, when, in fact, it was not.[7] In this case, the USDA sided with the meat industry in opposing the warning labels. The USDA's position changed, however, in the wake of the 1993 Jack in the Box E. coli outbreak, and the Agency announced its intention to require warnings and cooking instructions on all meat and poultry products. And, not surprisingly, the meat industry sued to stop this new policy, winning a delay on largely technical grounds.[8]

Explaining its opposition to the warning labels and cooking instructions, a spokeswoman for the American Meat Institute said: "Warning labels really frighten the public...If consumers follow safe handling procedures, there's no need to scare people about what is really a very wholesome and nutritious product."[9] And so, the meat industry wanted the public to be responsible for making meat safe to eat, and to in every instance cook meat perfectly so that no pathogens might survive, but, above all else, they did not want to "scare people." Talk about wanting to have it both ways! The meat industry wanted the public to think that meat was perfectly safe--that is, so long as it was perfectly cooked first.

Of course, no one has been telling the public that perfection is required if safety is to be expected. Instead, the instructions that finally found their way onto meat packages advises only: Cook thoroughly. And what, pray tell, does "thoroughly" mean? Would it have been so hard to say something like: Cook to an internal temperature of 160 degrees Fahrenheit, as measured by an electronic thermometer in at least five locations? Apparently, though, providing consumers with complete and accurate information was simply too much to expect.

To make matters worse, as late as 1997, the USDA was encouraging consumers to cook ground beef until "brown" in the middle to assure that a safe temperature had been reached. The only problem with this approach, however, is that it does not guarantee that the ground beef will in fact reach a temperature sufficiently high to kill all the bacteria that might be present. Once this problem was belatedly recognized, the USDA began its efforts to encourage the use of food thermometers. "Yet, the 2006 FDA/USDA Food Safety Survey of consumers indicated that only 13% of consumers always or often use a thermometer when cooking or grilling hamburgers."[10] And as if there was not enough confusion out there about how to safely cook a hamburger, the companies who manufacture and sell frozen ground beef patties have put a mind-boggling variety of different of cooking instructions on their respective packages. As one study concluded:

Since most consumers do not use a food thermometer to determine the doneness of ground beef patties, accurate cooking instructions are also needed. The wide range of recommended cooking times, 1.5 to 8 minutes per side for 113 g. patties, and conflicting information about the use of color to predict doneness of cooked meat and about avoiding both overcooking and undercooking, provide an array of confusing instructions for consumers who may buy a variety of package types when selecting frozen ground beef patties over time.[11]

This means that, even if a consumer follows the cooking instructions printed on the package, and does so to the letter, the cooked ground beef patty still might not be safe to eat.

Ultimately, then, I think what we need is a little realism here. If the manufacturer of frozen ground beefs patties is not willing to exercise the care necessary to prevent E. coli O157:H7 from contaminating its product, and is not willing to provide starkly clear warnings and accurate cooking instructions on its packages, it is time for the meat industry to shut up about so-called consumer responsibility. Like Lady Macbeth, the responsibility of the meat industry for the death and injury caused by contaminated meat is not something that can be easily washed away.

1. For a more detailed critique of Mr. Boyle's assertions, which are there quoted at greater length, please see my essay, Lies, Damn Lies and Statistics (Oct. 21, 2009).

2. To provide an example, there is her opinion piece entitled "Increasing Hunger and Regulation" in which she argues that regulations cause hunger by increasing the costs of production, explaining, by way of example, that "the movement to put restrictions on the use of land for farming can easily result in less land under cultivation and down the road a shortage of food." She continues this line of argument in "Why Do You Think We Have Factory Farms," in which she proclaims "I'm getting more and more frustrated with the idea that small farms can feed the world." To which I reply--Well, of course, small farms cannot feed the world, if "feeding the world" is defined as providing each person on the face of the earth a daily allotment of cheap industrially-raised chicken or beef. Oh, and by the way, we already are not feeding the whole world, at least not very well. But I digress.

3. Dr. Marsden's opinion piece can be found online here (although free membership sign-up is required for access): http://www.meatingplace.com/MembersOnly/blog/BlogDetail.aspx?blogID=11&topicID=5683

4. See Michael Moss, "Safety of Beef Processing Method is Questioned," New York Times, Dec. 30, 2009.

5. Michael Ollinger, et al., Meat and Poultry Plants' Food Safety Investments: Survey Findings, USDA/ERS Technical Bulletin No. 1911 (May 2004) at p. 37 (noting that "ERS survey data suggest that the PR/HACCP rule has raised beef and poultry slaughter plant costs by about one-third of 1 cent per pound.")

6. See "Recent Developments Regarding Beef Products Contaminated With Escherichia coli O157:H7," 65 Fed. Reg. 6881, 6884 (announcing that the agency would hold a public meeting "to discuss FSIS' policy regarding [E. coli] O157:H7 and new information concerning the pathogen and its relation to human health.")

7. For a more detailed discussion of the APHA lawsuit, and the court ruling that allowed meat to remain warning-free, see my essay, BPI Ground Beef Salmonella Recall: Will the Meat Industry Sue, and Who Will the USDA stand up for?, at http://www.foodpoisonjournal.com/2009/08/articles/food-poisoning-watch/bpi-ground-beef-salmonella-recall-will-the-meat-industry-sue-and-who-will-the-usda-stand-up-for/

8. See Texas Food Industry Assoc., et al. v. Espy, 842 F. Supp. 254 (Dist. Tex. 1993) (granting a preliminary injunction on the grounds that the USDA had not followed the required procedures to adopt the new rule).

9. This quotation is taken from Marion Nestle's excellent book, SAFE FOOD, at p. 77. There you can also find a succinct and enlightening description of the meat industry's efforts to block the regulatory reforms that the USDA tried to put into place in response to the 1993 Jack in the Box outbreak. See Safe Food, pp. 62-97.

10. See Sandra McCurdy, et al., Label Instructions and Cooking Times for Retail Frozen Ground Beef, Food Protection Trends, p. 336, June 2009.

11. Id. at 339. [Full disclosure: My law firm contributed funding toward the completion of this study, which was done independently and subject to peer-review prior to publication.]

Organic vs. Conventional: A Bacterial Comparison

mcheung@marlerclark.com (Matt Cheung) — Sun, 21 Feb 2010 01:59:03 -0800

Many consumers associate organic food production with food safety. While there is an abundance of persuasive arguments supporting this connection, the claims are often not accompanied by credible, scientific studies. As a result, it is unclear whether advocating for organic production methods will actually lead to a safer food supply.

For a study to be recognized by the scholarly community it must usually go through a process called peer review. This process subjects the author's work to an impartial review by experts in the same field, who examine the methods, interpretations, and potential biases of the study.

One level above a peer-reviewed study is a meta-analysis. A meta-analysis is essentially a study of multiple peer-reviewed studies. The authors begin by surveying the literature, then select several quality studies relevant to the research question, and finally run statistical and analytical tests to derive their conclusions.

The objective of this article is to summarize the findings from two meta-analyses that compared the prevalence of various foodborne pathogens between organic and conventional farming methods. It should also be noted that while E. coli O157:H7 and Salmonella were addressed in both meta-analyses, there were inconsistent findings between the relatively few studies and neither was discussed in great depth. Additionally, the focus of this article is solely on meat and dairy products, so it is entirely possible that fruit and vegetable production might have different results.

Article 1: Meat

The first meta-analysis was a comparison of bacteria and antimicrobial resistance in organic and conventional poultry, swine, and beef (Young et al. 2009). The study included a total of thirty-eight articles (1991 to 2008) from around the world, selected based on relevance and quality (sample size, statistical method, etc.). While two statistical tests did not reveal any publication bias, it was also not completely ruled out. Additionally, most of the studies were observational cross-sectional studies, which can only provide evidence of association, not causation.

Key Findings

1. There appears to be no difference in the prevalence of Campylobacter in organic and conventional retail chicken. The study found a higher prevalence of Campylobacter in organic broiler chicken at slaughter, but there was no difference at the retail level. One proposed explanation for the difference at the slaughter level is that organic chickens come from a slower-growing breed. The study also found that consumption of organic meats was a significant risk factor for C. jejuni. This conclusion was based on only one study, and the authors noted that future case-control studies would be needed before organic meat could be considered a risk factor for this illness.

2. Bacterial isolates from conventional broiler chicken, turkey, and swine production exhibited more antimicrobial resistance and multi-drug resistance than isolates from organic production. The article also found that the prevalence of ciprofloxacin-resistant Campylobacter was higher in conventional compared to organic retail chicken. Ciprofloxacin is an antibiotic used to treat severe cases of Campylobacter infection, so an infection from conventional meat may not respond as well to the drug. Additionally, significantly higher multi-drug resistance was reported in bacterial isolates from conventional chicken, swine, and pork in comparison to organic meat products, which suggests that antimicrobial use practices on conventional farms are more selective of multi-drug resistance than those on organic farms.

Article 2: Dairy

The second meta-analysis compared bacteria, antimicrobial resistance, and somatic cell count in organic and conventional dairy production (Wilhelm et al. 2009). A total of 32 studies (1992 to 2004) from around the world were found to be of high enough quality to be analyzed, and another 15 descriptive studies were also reviewed. The authors noted that there was potential publication bias based on language restriction.

Key Findings

1. There does not appear to be an association between prevalence of bacteria, antimicrobial resistance, or somatic cell count and dairy production type. In general, no consistent association was observed between the prevalence of zoonotic bacteria and whether production was organic or conventional. The authors noted that many of the studies conducted in the US sampled essentially the same group of herds, suggesting that the outcomes were not independent of one another. The number of studies for each type of bacteria was also very limited.

2. Smaller herd size was associated with higher somatic cell count irrespective of production type in North America. Somatic cell count can be an indicator of infections, so a lower level is desirable. Among four studies that controlled for herd size, no difference in somatic cell count was found in two studies, another study found that the difference was attributable to age-specific stratum, and the last study found a significantly higher level of somatic cells on organic dairy farms.

Conclusion

There are many reasons why consumers choose organic foods. Some believe that organic foods are of higher nutritional value, others fear the potential effects of pesticides and genetic modification, and many decide based on environmental or ethical concerns. Reducing the risk of foodborne illness, however, is not as compelling. The only significant difference between organic and conventional meat products appears to be antimicrobial resistance and multi-drug resistance. This means that people are as likely to be sickened from either, but an illness from an organic source might allow them to respond better to medication. Additionally, there does not appear to be any significant difference between organic and conventional dairy products. In fact, given that organic dairy farms tend to have smaller herd sizes, organic milk might actually have a higher level of somatic cell counts than conventionally produced milk.

While foodborne illness is only one of several issues important to our food system, it should not be taken lightly. In the U.S., there are an estimated 2.4 million Campylobacter infections and 1.4 million cases of Salmonella each year (pdf). These infections result from consuming food from a wide variety of sources, both organic and conventional. As a result, it is important to remember that proper safety precautions should be observed with all types of foods, regardless of the production method.

References

Wilhelm B, Rajić A, Waddell L, Parker S, Harris J, Roberts KC, Kydd R, Greig J, Baynton A. Prevalence of zoonotic or potentially zoonotic bacteria, antimicrobial resistance, and somatic cell counts in organic dairy production: current knowledge and research gaps. Foodborne Pathogens and Disease. 2009;6(5):525-539.

Young I, Rajić A, Wilhelm BJ, Waddell L, Parker S, McEwen SA. Comparison of the prevalence of bacterial enteropathogens, potentially zoonotic bacteria and bacterial resistance to antimicrobials in organic and conventional poultry, swine and beef production: a systematic review and meta-analysis. Epidemiol Infect. 2009;137:1217-1232.

Improved Nutrition Labels Can Help Fight Obesity

jnshaw@uark.edu (John N. Shaw) — Fri, 19 Feb 2010 01:59:03 -0800

The rates of obesity in the United States have dramatically increased to epidemic proportions, impinging on more than our good looks and athletic ability. Obesity is often associated with several health problems, including diabetes, heart disease, cancer, osteoarthritis and asthma. Additionally, studies have shown that obesity results in great public health cost. Aptly stated, it is imperative to consumers to understand and increase awareness of the information provided on Nutrition Facts Panels (NFP). In my opinion, companies can assist consumers in reducing costs and illness by creating visibly stimulating labels. This would help create awareness for consumers. Eating healthier not only supports consumer health, but assists in decreased health costs, controlled body weight, enhanced energy, and improved mood.

To give you an understanding and background on my stance, I am an avid exercise enthusiast who is concerned about my health and eating habits. Although I realize some may not put much emphasis on their health, there are numerous reasons to do so besides physical appearance. My article is solely my opinion and an endeavor to advocate food safety and health awareness by persuading consumers to read labels; thus improving their health and way of life.

With the economy in a slump, one of the main concerns with obesity is the increasing annual health cost. A study showed that obese Americans cost the U.S. about $147 billion in weight related medical bills in 2008, double of what it was a decade ago. In fact, obesity was responsible for "9.1 percent of annual medical costs in 2006 compared with 6.5 percent in 1998." Further, "people who are obese spent $1,429 (42 percent) more for medical care in 2006 than people with normal weight did." The benefits of eating healthier not only help the consumer lose weight, but are also a cost-effective way for improving public health. A number of recommendations have been suggested to help decrease this number.

What's ONE solution to decreasing obesity? According to a study by The Neilson Company, only 21 percent of U.S. consumers always check the nutritional information on food packaging. Further, research by the International Food Information Council (IFIC) illustrates few consumers actually understand how the Nutrition Facts Panel (NFP) fits in with their daily diet. The IFIC is making an impact by researching how to "effectively communicate science-based information on health, nutrition, and food safety for the public good." Hopefully, this research will help bridge the "disconnect" between consumers and their awareness.

I submit that most nutrition labels are neither appealing nor motivating to read (albeit some intentionally). The IFIC's study reveals that many factors and influences impact consumer food choices. Understanding these influences is extremely important in curbing obesity and improving consumer health. A few of the challenges the research found were:

Consumers find serving size information misleading;
Consumers do not consider their consumption of foods and beverages in the context of their daily intake; and
Consumers do not realize information to help them interpret daily context exists on the current NFP (%DV, or percent Daily Value).

The IFIC's research, along with my own proposals, suggest solutions to consumer challenges that would considerably help the consumer understand the Nutrition Facts Panel (NFP). A few of these suggestions include:

Companies should "clarify the service size." To do this, producers could illustrate that serving size is not arbitrary and increases consumers' ability to comprehend how serving size relates to the entire NFP. Include a government body, such as the FDA. This inclusion increases the perception of truth in the information provided, particularly in serving size.
The second enhancement would be to call attention to daily intake. The Foundation suggests encouraging consumers to think about all the foods and nutrients that make up a balanced diet.
Move the location of calories into the main body of the NFP. This encourages greater use and visibility.
Finally, the Foundation suggests simplifying the Percentage (%) of Daily Value (DV). To do so, companies could move the %DV explanation footnote into a column next to %DV to encourage consumers to think about how serving size relates to teh entire NFP. Adding the %DV of calories helps consumers consider a product within the context of their daily diet.

Companies could make an inherent impact on consumer health by making the nutrition labels clear, readable, and more appealing to the reader. This can be achieved simply by adding color, bigger font, and highlighting different characteristics of the product's ingredients. I realize this may be unpopular with some companies, however, from a consumer health standpoint, it would significantly facilitate the fight against obesity. A final suggestion is to encourage health awareness at an early age in schools. (Michelle Obama has made this a priority and seems to be making immense strides.)

Obesity is rising to epidemic proportions and can be a strain on consumers' health and financial means. In order to lessen the health and economic burden of obesity, it is critical that consumers understand and take notice of Nutrition Fact Panels. Although this is by no means the cure to rising health costs, it can unquestionably reduce the economic burden and constraints placed on consumer health.

References

1.   http://www.foodinsight.org/Resources/Detail.aspx?topic=IFIC_Foundation_Food_Label_Consumer_Research_Project
2.   http://www.foodnavigator-usa.com/Financial-Industry/Research-finds-daily-value-amounts-poorly-understood
3.   http://www.marketingcharts.com/print/us-consumers-mostly-understand-nutrition-info-on-food-packaging-5643/
4.   http://www.fda.gov/Food/LabelingNutrition/ConsumerInformation/ucm078889.htm
5.   http://www.medicalnewstoday.com/articles/158948.php
6.   http://www.cdc.gov/media/pressrel/2009/r090727.htm

Reaction: The Science Behind Salad Safety

tvsuslow@ucdavis.edu (Trevor Suslow) — Thu, 18 Feb 2010 01:59:02 -0800

Here, Trevor Suslow, Ph.D., shares his reaction to the recent Consumer Reports article
Packaged Salad Can Contain High Levels of Bacteria. Suslow is a cooperative extension research specialist in postharvest quality and safety in the Department of Plant Sciences at the University of California at Davis.

Yes, once again this type of bacterial testing activity has caused a flurry of concern and confusion. I support the notion that there is always room for improvement in food safety management and that FDA should increase the specificity of their guidance and regulations, where warranted and defensible, to include science-based standards and microbiological limits for fresh produce.

However, I feel it is grossly unfair to consumers to raise a specter of fear well beyond what is supported by available science and our everyday shared experiences. What I rely on for my personal confidence in regularly consuming lettuces, spring mix, and spinach salads is that there are billions and billions of servings of these items consumed every year in the U.S. alone and the predominant experience we have is of safe consumption.

No one wishes to dismiss the fact that such consumption likely results in sporadic cases of illness that aren't known by the public health system and have caused multiple outbreaks and tragic consequences for individuals and families. Continued efforts by the industry, FDA, and consumer advocacy groups to elevate performance standards for prevention and process management along the whole food chain at a national level are certainly warranted.

Uniform and accepted microbiological standards, as stated in the Consumer Reports report (See Study Finds Bacteria in Packaged Greens, Feb. 3), are not available at this time. I believe the criteria that were chosen do not provide sufficient information, by themselves, to judge the sanitation performance or risk to consumers.

First let's take care of one issue, from my perspective; a normal head of lettuce is colonized--not contaminated--with a diversity of microbiota, including diverse types of bacteria. Only a small fraction of the total normal bacteria on lettuce can be grown or cultured in the lab. The total numbers of bacteria on a leaf far exceed the number of a single group like the total coliforms that were a prime target in the survey. A smaller subset of total coliform bacteria are the fecal coliforms. We eat lots and lots of microbes all the time.

Second, total coliforms and fecal coliforms are defined by a set of culture-dependent lab criteria. This long-standing and convenient trait-based classification includes non-harmful E. coli and other related bacteria associated with fecal origin.

An estimate of the number of total coliforms generated by the lab tests also includes many other related bacteria that are part of the normal and expected group of plant colonizers. We are all exposed to plant-associated bacteria and consume them on a regular basis, often in large numbers like those reported in the survey.

Some that are not necessarily of fecal origin are recognized to be opportunistic pathogens, as a group, but the role of environmental isolates in causing human illness, as compared to the same taxonomic species from a hospital environment, is much less certain. Even here, illness with this group is more associated with problems that arise from inhalation or injection with non-sterile medical devices and equipment and other predisposing health factors.

However, I am certainly not a medical or public health expert and I am simplifying this quite a bit just to ensure that you are aware that a total coliform or fecal coliform doesn't necessarily indicate fecal contamination in the plant world. Their numbers on a leaf or fruit do not relate well to risk of illness or true and serious pathogens being present. When one follows standard protocols, developed for dairy, meat, drinking water, and wastewater reclamation, for example, for enumerating total coliform populations from plants, one often gets high numbers of these plant colonizers. They are very tough to wash off and are not killed 100 percent even with the most elegant and sophisticated wash disinfection system.

It is certainly conceivable and has happened that contamination we should be concerned about would be present among these coliform bacteria, but it isn't automatic. The normal level of "fecal coliforms" (I prefer and always use the alternate classification Thermotolerant Coliforms; grows at 42 to 44 degrees Celsius or 107 to 111 degrees Fahrenheit) is generally a subset of this and often varies more widely from head to head and leaf to leaf; here again this is not a strong predictor of pathogen presence or risk of illness to consumers.

The suitability of enterococci as strong indicators of recent fecal contamination or pathogen presence is not well established for plant products. This group has also been shown to have an environmental phase (growth in soil and sediments) which complicates the interpretation of their presence. While enterococci are generally considered better indicators of fecal contamination, their presence is simply not a perfect associative indicator for direct environmental contact with fecal matter or gross sanitation failures.

That the survey results found higher numbers of total coliform near the end of Use By Date is not at all surprising as there will always be some at the end of the most vigorous wash and sanitizer treatment. These survivors can grow (slowly) at typical refrigeration temperatures and certainly could multiply more quickly if exposed to warmer temperatures.

Growth would be expected especially if exposed to fluctuating temperatures that go from coldest to warmer to cold. Higher numbers are also consistent with the stage of decline of freshness and natural plant senescence, the inevitable process of quality loss that goes hand in hand with an increase in spoilage organisms.

The Consumer Reports study results may be consistent with widely held concerns for better cold-chain control, especially with packaged salads and other pre-cut or ready-to-eat fruits and vegetables, all the way to the home consumer. Have we seen high counts seasonally or wash procedures that aren't optimal? Sure, but there is another possible explanation. Because all the samples were taken from retail stores, the numbers of bacteria (not that fact that they were present) may tell us more about the temperature history of the product than provide clear evidence of poor sanitation.

Purchasing packaged salads or whole heads is a matter of personal choice. We do both in my family. I always wash loose leaf lettuces to remove any adhering soil. I never wash packaged salads. I do not support or believe that re-washing packaged salads should be a recommendation for the home consumer. A large and diverse panel of experts published a comprehensive article in 2007* detailing the scientific evidence for the lack of benefit and the greater risk of cross-contamination in the home.

If one chooses to take advantage of the convenience and diversity of greens available in sensible serving portions or as complete salad meals, it is always best to look at the Best if Consumed By dating and take notice of the display case arrangement. Bags should be vertical in a row, not laid one on top of the other in stacks. Clamshell containers are displayed in various stacking or slanted row patterns which allow generous space for airflow.

I always make it a habit to check the display temperature by hand. This isn't perfect or necessarily an indication of safe or unsafe product but it is at least easy to tell if the air is really cool and the bags are very cool to the touch. Maybe our cell phones and smart-phones should come with an infrared digital thermometer function.

Comments regarding cold-chain management, product temperature at point of purchase (POP), and the role of the home consumer in handling of packaged salads have prompted additional requests for information. Two main questions regarding consumer recommendations emerged:

1.   Is post-purchase temperature equally relevant for quality and safety?
2.   Can consumers really judge if product has been temperature-compromised at POP?

Simple answers to the theme of Question #1 are not possible because exceptions to lower risk or higher risk can always be made and are equally valid. The most responsible answer is "It depends." However, this is unsatisfactory, especially when trying to provide information consumers can use as an everyday rule of thumb. So I will make a brief general attempt and hope any backlash is not too intense. To limit the scope of the response, I will stick with packaged salads for the most part.

Is post-purchase temperature equally relevant for quality and safety?

Temperature management and cumulative cold-chain history is predominantly a quality issue and determines a product's visual, sensory, and nutritive keeping-potential. The FDA Food Code (2009) has identified Time/Temperature Control for Safety (TCS) limits, at or below 41F (5C), for certain value-added produce that must be applied to distribution, storage, and display. This includes cut leafy greens as well as fresh cut cantaloupe, pre-sliced or diced tomatoes.

These are designated as TCS foods due to recurring outbreaks AND the known growth potential of bacterial pathogens on the product.   The recognized low infectious dose of many pathogens may be sufficient to cause illness in highly susceptible individuals and growth on the product is not necessary to cause great harm. However, not all possible pathogens and variants of these pathogens, that may infrequently find their way onto or into product, are equally infectious to all individuals.

Proper post-purchase temperature management may and likely has kept a bacterial contaminant, such as Salmonella or pathogenic E. coli, below the threshold for illness for an individual consumer. Improper post-purchase temperature management may and likely has contributed to elevating these pathogens above an individual's personal threshold and, by cross-contamination in serving, increased the chance of exposure in an individual portion from the same bag.

The absence of visual signs of improper temperature exposure, such as spoilage or decay, provides no assurance that significant growth of bacterial pathogens has not occurred. Recent research evidence suggests that the pre-consumption environment may increase the aggressiveness (lowering the threshold) by activating mechanisms for human infection.

In summary, with all best efforts at prevention and control, if pathogens are present in packaged salads the consumer is at risk of illness, possible long-term health effects, or death. Keeping packaged salads cold is essential to quality and may reduce risk to individual consumers though not likely all consumers of the same lot.

Can consumers really judge if product has been temperature-compromised at the Point of Purchase?

Yes and No. I'll bet you knew that was coming. Realistically the Yes is very small and No the more sensible response. So to keep this answer simple for a change, let's stick with the No side of the equation and talk briefly about a potential consumer-oriented solution that always crops up.

Time:Temperature Indicators or Integrators (TTI) have been around for a long time and used on many perishable products. The function of a TTI is to make improper and abusive temperature exposure, linked to known quality defect-inducing conditions, readily apparent by a simply visual inspection, usually a color change, color development (invisible to highly visible), or progressive loss of color bars on a small patch or tag. No equipment is needed and no special training is required for anyone to get the information.

There are many types and have been many improvements in accuracy and readability over the past 15 years. For the consumer, TTI's affixed to a bag, clamshell, or other individualized purchase unit would be the relevant location. These have been used in the EU for many years, including on value-added produce.

There are many arguments for and against the value of TTI labeling which is beyond the details of this response; retailers in the U.S. have consistently argued against their use. Do TTI's tell the consumer anything about product safety? Not really, apart from considerations for TCS in the answer to Question #1 above.

If the TTI validations, and therefore the rate of color-change, were adjusted to pathogen growth response rather than quality loss and shelf-life parameters it could be argued that a level of consumer protection had been achieved. Under the current boundaries at the low end of cold-chain performance, would safe product be destroyed? Highly likely. Could TTI's help simplify a consumer's POP decision about quality? I think so. Would the use of TTI complicate a retailer's liability? I will let the experts answer that.

*Recommendations for Handling Fresh-cut Leafy Green Salads by Consumers and Retail Foodservice Operators. 2007. Food Protection Trends. 2: 892-898
www.pma.com/view_document.cfm?docID=159

Who Benefits From Raw Milk?

aferguson@marlerclark.com (Alex Ferguson) — Mon, 15 Feb 2010 01:59:03 -0800

April 2009, eleven Colorado residents develop Campylobacter infections after consuming raw milk sold through a cow share program. September 2009, thirty-five Wisconsin residents develop Campylobacter infections after consuming raw milk sold through a cow share program. November 2009, three persons in Washington State develop pathogenic E. coli infections after consuming raw milk. January 2010, five persons in Saratoga County, New York develop Campylobacter infections after consuming raw milk.

The list could go on and on. Drinking raw milk is, to say the least, a risky proposition. Sure, raw milk advocates argue that we should look at the numbers of illnesses caused by pasteurized milk as a comparison. Unfortunately for raw milk supporters, the numbers just aren't in their favor. According to Centers for Disease Control and Prevention (CDC) documents (pdf), from 1973 to 2005, raw dairy products caused over 50% of milkborne illness outbreaks, despite the fact that only about one percent of the United States population drinks raw milk.

Without a doubt, the widespread use of milk pasteurization over the last 60 years has led to fewer incidences of foodborne illness. According to the Food and Drug Administration (FDA), tainted milk was the source of approximately 25% of all reported foodborne and waterborne disease outbreaks in 1938. Today, thanks to pasteurization, tainted milk accounts for less than one percent of such reported outbreaks.

Regardless of the clear safety benefits of milk pasteurization, there are still those among us that fight ardently for access to raw milk. They claim that raw milk cures everything from diarrhea to rickets, from ear infections to asthma. The claims made by sellers of raw milk often sound eerily reminiscent of the snake oil salesmen of yesteryear. The feverish tone of these raw milk advocates begs one question: Who are raw milk sales really helping--average consumers or the farms that sell raw milk for up to $13.00 per gallon?

Raw milk salesmen (and women) have turned into classic cure-all peddlers as a way to boost sales. I am certainly not disputing the fact that there might be health benefits associated with consuming the probiotics found in raw milk, even if the CDC doesn't agree, and even though probiotics can be found in many products. Nor am I claiming that farmers should be denied potentially lucrative revenue streams. The main problem I have with this issue is that the advocates have stretched their sales pitches too thin, claiming that cows excrete an elixir that treats almost any ailment. At the same time, they seem to be trying to sweep the potential dangers of consuming fecal-bacteria-tainted milk under the carpet. Unfortunately, the end result is that the real victims of this deceptive advertising are often persons with already-weakened immune systems, such as children and the elderly.

The raw milk debate strikes a particular chord with me because it is so intertwined with my legal field of interest, products liability. Products liability was born out of the need to hold producers of medicines liable for injuring consumers. The rationale behind holding producers liable was simple: consumers couldn't be expected to chemically analyze medicine before putting it into their bodies, therefore they had no choice but to rely on the producer's good word that the medicine did what it purported to do in a safe manner. From an ethical standpoint, this made sense. If a supposed expert advertises a product as safe, it doesn't seem morally sound to blame the consumer for his or her subsequent injury or death.

The birth of the products liability movement provides a valuable lesson about the raw milk debate of today. By today's standards, the claims made by producers of medicines in the mid-1800s often seem outrageous. Products containing large amounts of mercury were a common treatment for syphilis. Lead was also used to treat a variety of ailments. Scientists even suspect that Beethoven's death was likely due to lead poisoning, developed after a lifetime of exposure to lead-based medical treatments.

Of course, the error of comparing the treatment of diseases with toxic medicines to the treatment of diseases with raw milk lies in the fact that the dangers of such medicines were not known in the 1800s. The dangers of consuming raw milk, on the other hand, were known by scientific pioneers such as Louis Pasteur as early as 1862. Indeed, in the modern day there is no excuse for exposing persons with weakened immune systems to raw milk that is known to contain deadly bacteria.

Despite a clear history of outbreaks, and a history of contamination with deadly bacteria that was known by scientists over 140 years ago, raw milk advocates continue to fight for their right to consume the product and feed it to their children. The internet age has created new avenues for proponents to reach consumers. It has also created an unregulated communication forum in which assertions of fact are rarely questioned. That sentiment of course applies to this article as much as it does any article posted on the World Wide Web. But, I would urge consumers to think long and hard about the goal behind campaigns that tout endless positive benefits of a product, side by side with sales pitches about the lucrative cash-earning potential of product sales. Like the products of yesteryear, we may one day look back in horror at the health risks consumers were willing to take in the name of a product that claimed to cure everything from heart disease to stomach cancer.

As with medicine, I will be the first to admit that some milk is more dangerous than other milk. There are relative risks and benefits of consuming either raw milk or pasteurized milk. Nonetheless, for the sake of my own health, I would rather avoid medications and milk that are not subjected to a sterilization process. Then again, I don't pretend to have all the answers. There may be some great benefits to raw milk, but it's hard to ignore the federal government's pleadings to stop the sale of raw milk. The government may be wrong. I may be wrong. Or perhaps, the reality is that raw milk is simply not a safe product to feed to our nation's children. Nonetheless, I'm sure that many raw milk advocates will unwittingly continue to paraphrase Stephen Colbert as they keep trying to convince us that reality has a well-known anti-raw milk bias.

Traceability: Is One Standard the Cure?

will.pape@TraceGains.com (William Pape) — Fri, 12 Feb 2010 01:59:03 -0800

"What the traceability industry needs right now is a single traceability standard".

This underlying theme was echoed in a number of presentations from several speakers at the recent Traceability Inter-Operability conference hosted by the Traceability Institute in Denver a few weeks ago. The main barrier to widespread traceability adoption by the food industry, these presentations argued, was the lack of a single traceability standard which could exchange traceability data seamlessly from one company to another throughout all their trading partners in a supply chain.

Unfortunately, each speaker was talking only about the traceability standard that their company commercially offers, and their implicit message was "If only everyone would speak my language, all companies in the food supply chain would be able to communicate and this industry would begin to rapidly grow." In other words, the presenters wanted all of the other solution providers in the audience to abandon their traceability solution and jump on the presenter's bandwagon--"my way or the highway".

This argument and this conference took me back to the early 1980's when I attended similar data interoperability conferences about how banks should be working together to begin electronically process credit cards. At that point in time, credit cards were handled manually rather than electronically. Many of you are old enough to remember the time when, at retail check-out, the store's cashier would put your credit card in a flat-bed device, nicknamed a "click-clack" machine, then put a receipt form on top of the credit card, and finally slide the click-clack machine's lever from one side to another, making an impression of the credit card and the merchant's information on the two-part paper form. After signature, the top paper copy was given to the customer and the bottom, cardboard copy was retained by the merchant and processed by the banks the same way they processed their checks at some later date.

In the early 1980's, the banks knew there were compelling reasons to process these transactions electronically in near real-time rather than wait many days to enter into their system, but they couldn't agree how to process and exchange this information. So, they held a number of conferences where each solution provider or "wanna-be" central data switch presented the arguments about why their company should be the one and only company to provide this electronic data interchange service and why their data standard was the only one that would work.

Not only wasn't a single standard adopted in the early 1980's, but each time you use your credit card today, it is likely to route through many different networks, each with a different data standard, and still be able to provide an approval or decline in a matter of seconds. In fact, there are over 64,000 different data standards and hundreds of different networks in existence among the global banking industry but to almost all consumers it appears as a single system.

Flash forward to 2010 and the Traceability Inter-Operability conference. The messages at this recent conference were the same as those at the early banking conferences thirty years ago--"Adopt a single traceability provided by my company and everything will be perfect."

From our perspective, this proposition is flawed on at least four levels. Firstly, there is the assumption that the lack of a clear interoperability standard is retarding the growth of traceability within the food industry. Secondly, this assertion assumes that a single standard will result in the best solution. Thirdly, there is assumption that a single traceability company will win all the chips. And fourthly, that full transparency of all traceability information equally shared with all trading partners is a good thing.

Based upon our experience in the global credit card industry, we believe each of these assumptions is false.

The growth of traceability companies is not being impeded by a lack of traceability interchange among companies because most companies haven't even taken their internal traceability conversation to that level. They are only concerned about internal traceability within their four walls, and they think they have already solved this problem with their one-up supplier and their one-down customer so they don't need the help of a third-party traceability supplier. Unfortunately, as we've discussed many times in this column, this belief is usually not anchored in reality and each time we've done a traceability audit with a food company, small or large, we've found glaring holes that would create serious problems for the company with the government regulators during a high profile recall. Even if most companies had flawless internal traceability, they don't have traceability data inter-operability on their radar.

Will a single standard from a single solution vendor be the best solution? In our strong opinion no single standard will meet all of the needs of every member of a single supply chain much less all supply chains. In the early 1980's we tried at my previous company, VeriFone, to push a single standard and got nowhere. Each bank wanted a different twist on the common theme and no single standard was going to work. The only way that we broke the logjam was to finally acknowledge that many solutions were going to need to bloom, each working within a loose, minimalistic standard.

The argument is likely to be made that the credit card example isn't the best model for food traceability data interchange because technology has changed today. This argument, which I've heard for many years, actually argues against a single standard because with today's technology it is so much easier for many different networks to bloom which can use modern middleware technology to inter-connect appearing as a seamless single network, but, in reality, being many interconnected networks.

So, if a single traceability standard promoted by a single company isn't the answer, what is going to work?

First, there has to be a realization that no single company and no single standard is going to win all the chips. Just as with the credit card system, each company, each supply chain will have its own unique objectives for a system and these objectives will be different even though there will be at least one common objective--being able to provide at the appropriate time an e-Pedigree for ownership of all the ingredients in a product from the retailer all the way back through all upstream processors to the first mile producers of all raw products used in a specific finished good.

To accomplish this objective, there are only a few "standard" things that need to be accomplished:

Agree on a numbering standard or a small set of numbering standards.
Agree on the minimum data elements that must be included by all players to create the e-Pedigree ownership traceback.
Agree how e-Pedigree data about upstream suppliers beyond one's immediate supplier must be kept confidential until these data are needed during a high-profile recall.

Yes, these are standards, but they are very minimalistic and skinny standards, and are the skeleton upon which many traceability solution vendors can hang added value services, and distinguish themselves among other traceability solution providers.

When principles similar to these three were applied to the credit card industry in the early 1980's, the electronic authorization and settlement of credit cards did begin to rapidly grow.

Let me conclude by strongly complimenting the newly formed Traceability Institute for organizing this important conference, and providing the forum for discussing this next important step. Providing education to food companies and providing unbiased leadership for the several companies offering traceability solutions is critical for our industry especially given that relatively few food companies have truly solved their internal traceability challenges much less begun to think about traceability data interchange with their trading partners.

As I noted during the conference, the true competitors at this point in time of companies offering traceability solutions are not the other companies offering traceability solutions, but the complacent food companies that think they have already solved the traceability issue only to find when they become involved in a high profile food recall that their systems fall far short of the mark, and their company is badly damaged or even destroyed. Working together through the Traceability Institute and other vehicles, traceability companies can be successful by identifying the minimalistic standards that will be needed for inter-operability, acknowledging they will not be the only winners, and then developing the specialized services that differentiate themselves from other service providers.

Further information can be found at www.tracegains.com.

Food Safety & Organic Management

carenw@carenwilcoxassociates.com (Caren Wilcox) — Wed, 10 Feb 2010 01:59:02 -0800

From peanuts and pistachios to spinach and tomatoes--product recalls in the last few years have had a huge impact on many user companies marketing both conventional and organic products, and have led directly to widespread calls for improvements in U.S. food safety laws. The U.S. House of Representatives has already passed new legislation, and while the Senate has not yet acted, it appears almost certain that a new food safety law will pass some time during this congressional term. As the organic community awaits the outcome of proposed legislation, there are food safety principles, detailed further below, that you can study and possibly even implement to help you be well prepared for future food safety regulations.

Organic Regulations and the U.S. Food Safety System

Organic regulations include several rules that promote safety, such as prohibiting the use of chemical contaminants, eliminating the use of antibiotics that can lead to antimicrobial resistance, and the regulation of the preparation of compost and use of manure. However, the organic standard in the U.S. is not legally regarded as a food safety standard; it's a marketing standard. Those in the organic processing business are well aware that in addition to meeting the strict standards of the National Organic Program (NOP), all organic products must meet the food safety rules and regulations applicable to each class of product in the United States, as well as food safety requirements for export.

The U.S. has a multi-faceted food safety system. Today, some products are regulated by the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS), while others fall under the stricter regulations of the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). A few other federal departments also have a piece of the action, as do state and even local governments. And, proposed national marketing agreements like that for "Leafy Green Vegetables Handled in the United States" (Marketing Agreement # 970), if implemented, will impose food safety practices on a "voluntary" basis. Voluntary is in quotes because marketing agreements such as this are proposed by groups within a commodity. Retailers then fall in line with the terms of the marketing agreement, so if you want to sell to them you have to "volunteer" to be in compliance. In the case of the leafy greens agreement organic practices would meet some strong challenges in the current proposal.

Improving Food Safety

Recalls and the practices they reflected to consumers and government authorities have caused considerable pressure to create new authorities to enable FDA to require preventive measures and to strengthen its enforcement capacity, and a review of the FSIS authorities is also under way. Congress is moving swiftly to strengthen the regulation of food safety practices. The Obama administration has taken steps to name a Food Safety Working Group, ordering new tracking and testing protocols even while new legislation is being discussed.

Third-party certification for food safety has been the subject of testimony and study in the conventional food industry and among members of Congress seeking food safety reforms. Because organic agriculture and processing is already subjected to third-party certification through the NOP, organic growers and processors are accustomed to meeting certification standards and this experience should help pre- pare organic businesses for new food safety procedures in proposed legislation.

While the legislation is still being considered, there are voluntary preparatory and preventive steps that all companies can consider, and even undertake. One of these preventive steps is incorporating solid sanitation procedures--and fortunately organic processing has many cleaning materials that are accepted for organic practices. Sanitation and facility planning has always been important in organic production--both on-farm and in the processing facility. Organic producers have known for a long time that it's easier to keep pests--insects, animals and microbes--out of the product (while still recognizing they should remain in their natural environment) from the beginning through proper sanitation rather than taking later steps to eradicate pests. This is especially important considering chemical or pharmaceutical intervention to kill pests is not permitted by the organic rules. Organic farmers who raise animals know that keeping animals and their living environments clean aids animal health. Sanitation is the first step to safer food and is a step that is achievable for organic production. In fact, many organic processing facilities have been built specifically to avoid vector harborage and unsanitary nooks and crannies that cannot be cleaned easily.

The legislative proposals also entail putting in place other "preventive" measures. One such protocol is Hazard Analysis and Critical Control Points (HACCP), a systematic approach to the identification, evaluation and control of food safety hazards. Any organic processor of meat and poultry is already covered by so-called "mandatory" HACCP and Pathogen Reduction (HACCP-PR). However, with a few exceptions, FDA-regulated companies are not currently required to have HACCP in place.

Understanding HACCP

HACCP was actually developed by a cooperative effort between industry and the National Air and Space Administration (NASA) to ensure that astronauts would not get foodborne illness while flying in space. For over 40 years it has been voluntarily placed into effect in many food plants, and has lowered the incidence of food safety problems in those plants. But it has not reached enough food production facilities, and some companies buying ingredients have apparently not required supplier companies to adopt HACCP practices. Clearly, neither conventional nor organic companies were demanding a stringent "preventive process" to be in use at Peanut Corporation of America, the company involved in the Salmonella debacle.

Over a period of three years, mandatory HACCP in the meat and poultry industries was successfully introduced into more than 6,000 plants that had not been previously operating with HACCP. And, while there is always room for improvement, HACCP-PR led to considerably enhanced food safety in meat and poultry in the early years following implementation. However, although CDC indicates that "significant declines in the incidence of certain foodborne pathogens occurred since 1996, these declines all occurred before 2004. Comparing 2007 with 2004 to 2006, the estimated incidence of infections caused by Campylobacter, Listeria, Salmonella, Shigella, STEC O157, Vibrio, and Yersinia did not decline significantly, and the incidence of Cryptosporidium infections increased." Thus improvement has plateaued during the early '00s, making it easy to understand the need for increased food safety efforts across the entire food sector.

Throughout the rest of the food processing industry, there are a variety of methods for HACCP implementation, but all are based on the same principles--with the variation around testing protocols, operations methods, and, of course, the advice of the lawyers and food scientists who consult on compliance in food safety.

HACCP is based on seven principles, including:

Principle 1: Conduct a Hazard Analysis. Pay special attention to the hazards that are likely to occur, such as metals, glass, pathogens, toxins and mycotoxins, zoonotic diseases, parasites, spoilage, and so forth. In addition, even though organic facilities may have strict regulations on use of chemicals, it's important to check for chemical, pesticide and drug residues. In organic operations, the area to pay the most attention to would be the surroundings, including the water used and potential overspray from conventional operations. A hazard analysis for pathogens might also look at pathways for unexpected hazards, such as those tracked in on employee shoes or boots not cleaned before entering the food plant.

Principle 2: Determine Critical Control Points (CCPs). Using insight gained through the analysis, facilities can identify points where they can control or reduce hazards. One example is to establish the point where a product actually is baked or cooked to a temperature needed to kill a pathogen. The point where that temperature ought to be reached, and its point of measurement, is a CCP.

Principle 3: Establish Critical Limits. A critical limit is a maximum and/or minimum value or physical parameter to which the CCP must be controlled in order to prevent, eliminate or reduce the hazard. An example would be the limits of both the time and temperature at which the product would have to be processed and held in order to kill a pathogen, or chilled to prevent pathogen growth.

Principle 4: Establish Effective Monitoring Procedures. This can include planned observations or other assessment measurements such as temperature recording and monitoring equipment, or a record of "test and hold" procedures and results if pathogens are likely to occur as hazards. Track the data from these assessments and create an accurate record for verification in the future. To continue the example above, one might have a thermometer measure and record the temperature during the process at set time intervals or as a continuous process.

Principle 5: Establish Corrective Actions. Action is necessary when critical limits are exceeded or monitoring procedures fail. Prior noted records will show these deviations. Pre-planned corrective actions can be used to prevent products that may be hazardous from reaching consumers. These actions could include "test and hold" procedures or recall procedures.

Principle 6: Establish Verification Procedures. This step goes beyond verification of the HACCP plan itself and includes looking at whether the HACCP plan is actually functioning in harmony with the facility or whether it is just "placed on top" of normal operations. Can the managers ensure through planned oversight that the overall HACCP plan is working? Has an analysis been done of how often an established CCP was not met? Did the company follow up with training to improve performance, and create a better plan, or did it fail to implement its plan effectively?

Principle 7: Establish Record-Keeping and Documentation Procedures. These records can be critical for guiding facility operations, or for legal compliance if the HACCP plan is mandated by law.

Food Safety Legislation

As noted, a food safety reform bill aimed at changing the authorities of the FDA recently passed the U.S. House of Representatives. While no bill has yet passed in the U.S. Senate, the House-passed bill has caused much consternation in the organic community since it appears to require additional procedures beyond those required by an organic system plan, such as additional or duplicative registrations, large fees assessed per facility, and different and potentially conflicting requirements for tracing of products when organic products must already be traceable backward and forward. A discussion known as a "colloquy" was held on the House floor during debate of the bill; this discussion was meant to clarify the House intention for organic farms and processors. A portion of that colloquy follows.

Representative Sam Farr, D-CA: "As a member of the Organic Caucus, I have concerns about the interplay between this bill and the National Organic Program. Is it the Chairman's understanding that this bill would not establish any requirements for organically produced or processed products which are in conflict with the requirements established by the Organic Foods Production Act of 1990 and the USDA's National Organic Program regulations? And would this bill necessarily require small farms to participate in an expensive and un-workable electronic traceability system that FDA will set up? . . .I would be remiss if I didn't mention my concerns with the fee structure in the measure."

Representative John Dingell, D-MI: "...We worked very hard to make sure that the bill would avoid these effects. We would be extremely concerned if this bill created a conflict between food safety measures and other farming practices aimed at protecting and sustaining the environment. The bill therefore has a number of provisions designed to prevent conflicts between organic regulations and proposed food safety legislation. For example, it requires FDA to take into consideration the impacts of any produce food safety standards on small-scale and diversified farms, on wildlife habitat, conservation practices, watershed-protection efforts and organic production methods. The bill also requires FDA to work in coordination with USDA and the administrators of the National Organic Program to ensure that safety standards are compatible with organic standards. Additionally, it prohibits FDA from setting any standards unless those standards are necessary to minimize the risk of serious adverse health consequences or death.

"Let me speak to your question about the traceability system in the bill. The traceability provisions in the bill are a critically important part because they will allow FDA to quickly track down the sources of foodborne outbreaks. Before FDA can establish any traceability requirements, the bill requires FDA to go through an extensive information gathering process, with public meetings and a pilot project. As part of that process, it requires FDA to consider the costs and benefits and the feasibility for different sectors of the food industry of any traceability technologies under consideration. And for any regulation that would have an impact on farms, FDA must coordinate with USDA, and must take into account the nature of the impact of the regulation on farms. Additionally, FDA will be prohibited from requiring farms selling food directly to consumers, restaurants, or grocery stores to participate in this system..."

The Impact of Legislation on Organic Farming

The required communication between the FDA and USDA outlined in this colloquy helps demonstrate that the House leadership has heard the concerns of the organic community. Although it appears improbable that final legislation will impose strict requirements on small farmers directly marketing to consumers, it seems certain that the bill will impose strong food safety procedures on the rest of the food industry after FDA and USDA consider risks, costs, and benefits of additional food safety steps.

We don't know what the new law will require--the Senate may not accept all that the House has passed, and FDA may decide to implement preventive measures in a very specific regulatory framework. Ultimately, the principles cited above are just a description of the HACCP points that have been used for many years, but may not be used by FDA. The current House-passed version is a very complex bill, and will bring major changes to food processing in the U.S., and around the world in food plants that wish to export to the U.S. This discussion has only covered some of the potential operational challenges that may lie ahead.

No matter what happens, understanding prevention will help regardless of what is required by law in the future. And in those principles, organic practitioners should have heard a strong echo of some of the principles already followed in order to produce certified organic products. A number of the requirements being proposed in the legislation for every food processor are already being accomplished by organic processors. For instance, because all organic production establishments are registered with USDA, an effort is under way to keep certified organic organizations from having to register twice. Organic farmers and processors already have a traceability system--one backward and one forward. And, the concerns of organic farmers and processors are being presented to lawmakers.

Organic companies have an advantage over conventional processors who have never been subject to third-party certification, and who will be starting from scratch. Organic practitioners also know that as a systems plan is put in place there can be new developments in procedures that have to be evaluated and inserted into the process--an insight gained when one operates from a perspective of continuous improvement. While we cannot know now what version of the legislation will actually become law, as the food safety debate continues it is wise for organic processors to prepare and learn more about these additional voluntary processes, recognizing that some version of them may soon be required by U.S. law.

"Food Safety Legislation: Special Concerns and Opportunities For Organic Managing" originally appeared in the November-December 2009 issue of Organic Processing Magazine. Reprinted with permission of the author and publishers. © 2009 by The Target Group

Tax Incentives for Food Safety

aferguson@marlerclark.com (Alex Ferguson) — Sun, 07 Feb 2010 01:59:03 -0800

As a society we must accept the fact that large-scale food producers are motivated by money, not safety. They seek low production costs to bolster slim margins, not methods by which to rid food of illness-causing pathogens. In order to incentivize large-scale producers to make safer products, we must demand more hands-on oversight and a tax system that rewards the producers with the best safety records. In a profit-driven world, we need to promote safety through better margins. We must fight money with money.

The food industry is not an easy business to thrive in. There are high barriers to entry and sizeable production costs. It's also extremely difficult for food producers to differentiate their products from the competition. Sure, you can sell organic yogurt, hormone-free milk, and soy ice cream, but it's not as if you can reinvent the (cheese) wheel. To make matters worse, many consumers are currently in dire financial straits. For many people, feeding their families in the most affordable way possible has become a top priority. And thus, we've ended up with grocery store super-centers packed full of low price, high quantity food products. Quality, often times, seems like an afterthought.

As consumers, we pay a hefty price for the food industry's never-ending race toward rock-bottom prices. To produce products that are continually cheaper and more profitable, the food industry has learned to cut corners at every step of the production process. This, in turn, has led to more ways that harmful pathogens are able creep into our food supply. We have seen it again and again. From fields of leafy greens inundated with cow pasture runoff water to peanut processing plants that ship products regardless of contamination, manufacturers are quick to latch on to any practice that may shave a few cents off production costs.

Consumers, it should be noted, are not naïve. With a population that needs to put food on the table, the race toward bargain basement food prices might not seem like such a bad thing. Really, who can blame them for seeking out affordable food products? With a combined 2010 agency budget of over $138 billion, consumers should be able to trust the USDA and the FDA to keep our food safe. We should be able to walk to the corner grocery store and buy a frozen dinner without worrying that the meal could land us in a hospital room on dialysis.

Unfortunately, the assumption that the government will keep our food safe leads to a crucial mental trade-off. It creates a mindset where American consumers are not prepared to pay more money for safer food. After all, with the government already spending hundreds of billions of dollars in the name of food safety, who in their right mind would pay more for a pathogen-free bag of spinach; it's already supposed to be that way! Likewise, what manufacturer is going to label its food as "pathogen free"? That's just a lawsuit waiting to happen.

The segment of shoppers that actively searches for pathogen-free food is a slim one indeed. Some more affluent shoppers may shop at upper-end stores that are full of organic produce and meats. Those shoppers, however, are paying for a lack of chemicals and additives; there is still an implicit assumption that the food, so long as it's on a store shelf, is safe from foodborne pathogens.

Educating the public about food safety is one component of a long term solution to the epidemic of foodborne illness. Another more crucial component is educating manufacturers about the financial benefits of safe food. If we can create a corporate culture where safe food means higher profits, manufacturers will quite literally race to improve product safety. It has worked in other industries, and it will work with food producers, given the right incentives.

Early on, I learned that there are a lot of industries with much worse safety records than the food industry. Growing up in a small town in eastern Washington, my family's Friday evening trips to Costco were always a highlight of my week. As a ten year old, it doesn't get much better than browsing countless rows of electronics and chasing down free samples of everything from cookies to quesadillas. But one thing always caught my eye when I was leaving the store. There was a big sign, likely inspired by similar signs at construction sites, which tallied the number of consecutive days without a workplace injury. Even as a ten year old, I was curious to see how long the store's injury-free streak could continue. The sign represented the ambitions of a company that prided itself on the safety of its employees and wanted to show its pride to the local community.

It wouldn't be such a bad thing if more companies began to pride themselves on the longevity of their safety records. Even better, what if food producers began to pride themselves on the safety record of their products? Why would they do this? What does a company in a competitive industry that knows it can't sell safety have to gain from a flawless safety streak? Well, nothing, until you create governmental incentives that offer monetary rewards to the producers with the best safety records. This in turn gives producers of safe products a distinct competitive advantage in an industry with extremely narrow margins.

The setup for a governmental system that rewards safety is pretty simple. The first step that the federal government must take is to institute a special tax that applies all food producers that ship products across state lines. The tax should target large producers, not small local farms. The funding generated by the tax can be used to pay for more hands-on oversight, including more extensive inspection and traceability systems. At the end of every fiscal year, companies should be able to, based on their food safety records, apply for a small percentage tax reduction. Such a system rewards producers that are able to continually avoid foodborne illness outbreaks, increasing their profit margins and giving them an edge in a competitive industry.

Certainly, a system of tax incentives for companies with great food safety records is not without flaws. For starters, large producers and mid-sized farmers alike would have to be dragged, kicking and screaming, into an industry-wide tax hike. The large producers would argue that it's impossible to avoid mishaps in high-volume production facilities, whereas the farmers would argue that more taxes would cut into their already non-existent margins. For each argument, however, there is of course a counter argument. Large producers would still retain the competitive advantage of lower production costs as a result of economies of scale, and farmers would still enjoy the benefit of smaller operations with simpler oversight procedures.

The reason why tax incentives could lead to a safer food supply is easy to understand, so long as you look at the food industry from a fresh perspective. In any discussion of food safety, two simple realities are often overlooked. The first is that the average consumer is rarely aware of the dangers of contaminated food. Consumers assume that the food they buy off a store shelf is safe--they are not willing to pay an additional cost for more food safety. The second is that food producers, like all other corporations, exist to make money for their shareholders. There is nothing wrong with that, it's what our country's economy is based on. But there is something wrong with assuming that producers will pay more attention to food safety if it does not benefit them financially.

Putting these two realities together, we can clearly see that the most effective food safety approach is one in which producers are financially motivated to produce safe food. Under such an approach, the average consumer can, in fact, purchase any product off a store shelf with the peace of mind that the company that manufactured the product made safety a top priority. It's time we reward companies that are trying to create safer food products. It's also time we stop paying for industry profits with our lives.

Oysters, a Simple Food with a Complicated History

aweisbecker@marlerclark.com (Andy Weisbecker) — Thu, 04 Feb 2010 01:59:03 -0800

With the New Orleans Saints playing in the Super Bowl and Fat Tuesday just days away, it's quite likely that large amounts of raw oysters will be consumed over the next couple of days, maybe even the next couple of weeks, at various bars, restaurants, and parties. What is less certain is the level of risk to those consumers created by their gulping down those delicacies.

First, the good news. Oysters have been prized from the early days of civilization for their silky texture and taste of the sea. The cultivation of oysters began more than 2,000 years ago when Romans collected oyster seed stock near the mouth of the Adriatic Sea and transported them to another part of Italy for grow-out. The Romans had such a passion for oysters that they imported them from all over the Mediterranean and European coasts. Also, raw oysters nutritionally consist of 23 percent carbohydrates, 33 percent fat and 44 percent protein. This makes them a balanced food and a good source of protein and Omega-3 fatty acids. Oysters are a good source of zinc, selenium, vitamin D, iron, magnesium and phosphorus. [1]

Perhaps of equal importance, raw oysters have always been linked with love. Aphrodite, the Greek goddess of love, sprang forth from the sea on an oyster shell, promptly gave birth to Eros, and the word "aphrodisiac" was born. Casanova, the renowned 18th century lover, famously used to breakfast on 50 oysters. This may not be simply myth. A team of American and Italian researchers in 2005 analyzed bivalve mollusks - a group of shellfish that includes oysters - and found they were rich in rare amino acids that trigger increased levels of sex hormones. The scientists stressed that the oysters have to be eaten raw to be most effective!

In contrast, raw oysters may contain a number of different harmful bacteria, and have been linked to serious illness and death. As such, food safety experts and public health agencies have consistently warned of the serious potential risk created by these mollusks, when consumed uncooked.

The harmful bacterium most commonly associated with the consumption of raw oysters is Vibrio vulnificus. It is a bacterium in the same family as those that cause cholera. It normally lives in warm seawater and is part of a group of Vibrios that are called "halophilic" because they require salt. V. vulnificus can cause disease in those who eat contaminated seafood or have an open wound that is exposed to seawater. It is found in all of the coastal waters of the United States. Environmental factors responsible for controlling members of V. vulnificus in seafood and in the environment include temperature, pH, salinity, and increased dissolved organics. [2]

V. vulnificus causes wound infections, gastroenteritis, or a syndrome known as "primary septicemia." Wound infections result either from contaminating an open wound with sea water harboring the organism, or by lacerating part of the body on coral, fish, etc., followed by contamination with the organism. The ingestion of V. vulnificus by healthy individuals can result in gastroenteritis.

Ingestion of the organism by individuals with some type of chronic underlying disease [such as diabetes, cirrhosis, leukemia, lung carcinoma, acquired immune deficiency syndrome (AIDS), AIDS- related complex (ARC), or asthma requiring the use of steroids] may cause the "primary septicemia" form of illness. A recent study showed that people with these pre-existing medical conditions were 80 times more likely to develop V. vulnificus bloodstream infections than were healthy people. In these individuals, the microorganism enters the blood stream, resulting in septic shock, rapidly followed by death in many cases; the mortality rate for individuals with this form of the disease is over 50%. [2]

Although oysters can be harvested legally only from waters free from fecal contamination, even legally harvested oysters can be contaminated with V. vulnificus because the bacterium is naturally present in marine environments. V. vulnificus does not alter the appearance, taste, or odor of oysters.

V. vulnificus is a rare cause of disease, and is likely underreported. Between 1988 and 2006, CDC received reports of more than 900 V. vulnificus infections from the Gulf Coast states, where most cases occur. Before 2007, there was no national surveillance system for V. vulnificus, but CDC collaborated with the states of Alabama, Florida, Louisiana, Texas, and Mississippi to monitor the number of cases of V. vulnificus infection in the Gulf Coast region. In 2007, infections caused by V. vulnificus and other Vibrio species became nationally notifiable. [3]

Another Vibrio pathogen often associated with raw oysters is Vibrio parahaemolyticus. V. parahaemolyticus is a marine bacterium that occurs naturally in filter-feeding molluscan shellfish, like oysters. V. parahaemolyticus is also a bacterium in the same family as those that cause cholera. It lives in brackish saltwater and causes gastrointestinal illness in humans. V. parahaemolyticus was first implicated in an outbreak of food poisoning in Japan, in 1950, and has been associated with sporadic cases and outbreaks (multiple cases) of illness in the United States since 1969. An estimated 4500 cases of V. parahaemolyticus infection occur each year in the United States.

Most people become infected with V. parahaemolyticus bacteria by eating raw or undercooked shellfish, particularly oysters. Less commonly, this organism can cause an infection in the skin when an open wound is exposed to warm seawater. When ingested, V. parahaemolyticus causes watery diarrhea often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion. Illness is usually self-limited and lasts 3 days. Severe disease is rare and occurs more commonly in persons with weakened immune systems. [4]

Public health agencies have been consistently warning of these potential risks associated with the consumption of raw oysters. The U.S. Food and Drug Administration (FDA) has advised people with certain medical conditions not to eat raw oysters, and to only eat oysters that have been thoroughly cooked. In people with medical conditions such as cancer, diabetes, or liver disease death can occur within two days. The FDA list of such medical conditions includes: liver disease (from hepatitis, cirrhosis, alcoholism, or cancer); iron overload disease (hemochromatosis); diabetes; cancer (including lymphomas, leukemia, Hodgkin's disease); stomach disorders; or any illness or medical treatment that weakens the body's immune system, including HIV infection. [5]

People who drink alcoholic beverages (including beer and wine) regularly may be at risk for liver disease, and, as a result, may also be at risk for serious illness or death from consuming raw oysters. Even drinking two to three drinks daily can contribute to the development of liver disease, which may occur without symptoms. Alcoholism and infections from Hepatitis can injure the liver and impair its function years before an individual begins to experience symptoms. Liver disease puts people at risk for V. vulnificus infection from raw oysters. The risk of death is almost 200 times greater in those with liver disease than those without liver disease. [5]

In June of 2005, the FDA issued its "Letter to Health Professionals Regarding the Risk of Vibrio vulnificus Septicemia Associated with the Consumption of Raw Oysters". The letter asked for the help of health professionals in alerting their patients in the at risk group about the threat of Vibrio vulnificus septicemia associated with the consumption of raw oysters. The FDA therefore advised that those persons at-risk for V. vulnificus septicemia should only eat oysters that have been fully cooked. [6]

In addition to the Vibrios, raw oysters may also contain other harmful organisms. In March 2007, the FDA issued an alert regarding an outbreak of norovirus-associated illness linked to eating raw oysters harvested from San Antonio Bay, TX. Illnesses had been reported by 25 individuals who ate raw oysters at an event in Maryland. The Maryland Department of Health & Mental Hygiene's test results from ill patients were positive for norovirus. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness within 48 hours of exposure to the virus. The implicated oyster beds in San Antonio Bay were closed for some time, and the oyster distributors issued voluntary recalls of the product. [7]

The FDA has consistently sought to dispel a number of common but wrong assumptions about the risks involved with the consumption of raw oysters. These myths include: eating raw oysters is safe if you drown them in hot sauce, which kills everything; avoid oysters from polluted waters and you'll be fine; an experienced oyster lover can tell a good oyster from a bad one; alcohol kills harmful bacteria; just a few oysters can't hurt you; and avoid raw oysters in months without the letter "R" and you'll be safe. [5]

The 2005 FDA Food Code currently recognizes that food establishments may serve undercooked animal foods to a consumer upon his or her specific request, if the consumer is properly advised of the hazards associated with eating undercooked animal foods. Many consumers and food establishments exercise this "consumer advisory" option with oysters. For oysters, the term "fully cooked" means that the product is allowed to reach an internal temperature of at least 145°F for 15 or more seconds. The FDA Food Code contains additional recommendations for safe food handling practices in retail and foodservice operations.

The risk posed by raw oysters has also been addressed by various legislatures, which have typically mandated related warnings to potential consumers. For example, California mandates a warning that contains the language " THIS FACILITY OFFERS RAW OYSTERS FROM THE GULF OF MEXICO. EATING THESE OYSTERS MAY CAUSE SEVERE ILLNESS AND EVEN DEATH IN PERSONS WHO HAVE LIVER DISEASE (FOR EXAMPLE ALCOHOLIC CIRRHOSIS), CANCER OR OTHER CHRONIC ILLNESSES THAT WEAKEN THE IMMUNE SYSTEM." See, 17 CCR 13675. Florida requires a warning stating "Consumer Information: There is risk associated with consuming raw oysters. If you have chronic illness of the liver, stomach or blood or have immune disorders, you are at greater risk of serious illness from raw oysters, and should eat oysters fully cooked. If unsure of your risk, consult a physician." See, 64D-3.040, F.A.C.

Finally, the courts have also addressed the nature of risk posed by raw oysters, primarily in the context of personal injury claims, with somewhat inconsistent results. Louisiana's highest court, for example, has held that the Vibrio vulnificus bacteria, which occurs naturally in the Gulf of Mexico, and is harmless to most people, does not render raw oysters containing the bacteria unreasonably dangerous. Thus, neither the distributor of oysters nor a restauranteur was liable where the plaintiff died after consuming raw oysters containing these bacteria. See, Simeon v. Doe, 618 So. 2d 848, 851 (La. 1993). A Kentucky court found that the presence of Vibrio bacteria in raw oysters did not constitute a manufacturing or design defect, because there are no reasonably available alternatives to bacteria-laced oysters, screening is not feasible, and bacterium poses little threat to healthy persons. See, Edwards v. Hop Sin, Inc., 2003 Ky. App. LEXIS 213, at *4 (Aug. 29, 2003).

In contrast, a Texas court found that there is no question Vibrio vulnificus bacteria are highly dangerous to people who suffer an immunosuppressed condition. Therefore, the issue of whether raw oysters constitute a product that is "dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics", could not be resolved as a matter of law, and needed to be determined by the trier of facts. See, Ayala v. Bartolome, 940 S.W.2d 727 (1997). In Cain v. Sheraton Perimeter Park South Hotel, 592 So. 2d 218 (Ala.1991), a patron sued a hotel and its restaurant alleging that he contracted hepatitis from consuming raw oysters served by the restaurant. The Supreme Court of Alabama held that a fact question was presented as to whether a patron should have reasonably expected that raw oysters may have been contaminated.

Most recently, during the fall of 2009, the issue of raw oyster safety was again raised, and publicly and heatedly debated. On October, 17, 2009, the FDA announced, at a meeting of shellfish regulators, the agency's intention to reformulate its policy on processing raw oysters to reduce Vibrio vulnificus. The FDA announced that it would change HACCP rules to require post-harvest processing to reduce the risk posed by the bacterium. The new rule was intended to take effect by the beginning of risk season in 2011.

"There's just a very clear public health case," said Michael Taylor, the top food safety official at the FDA. "Vibrio is one of the most horrific infections we know about. Fifteen people a year die from this. It's excruciating. And the people who don't die suffer life-changing injuries. But we can prevent this." Federal officials, who are emphasizing food safety improvements, point to California as an example. Between 1991 and 2001, 40 people in California died of Vibrio infection. In 2003, the state banned raw untreated oysters from the Gulf during warm months and fatalities dropped to zero, Taylor said.

Oystermen, state officials, and their representatives on Capitol Hill, however, quickly complained that the federal government was overreaching, and was likely to destroy a gastronomical delight and its related industry, setting off a flurry of political action. Opponents of the proposed new rule argued that antibacterial processing, which is similar to pasteurization, would ruin the taste of raw oysters, triple their cost, and place excessive burdens on a business with over 3500 workers, and with deep cultural and culinary roots, that was already at risk.

The FDA reacted by temporarily shelving the proposed new rule. On November 13, 2009, in a media release, the FDA announced "Since making its initial announcement, the FDA has heard from Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls by the summer of 2011. These are legitimate concerns." Accordingly, the FDA delayed the implementation of the rule, deciding instead that, prior to its proceeding, it would "conduct an independent study to assess how post-harvest processing or other equivalent controls can be feasibly implemented in the Gulf Coast in the fastest, safest and most economical way." [8]

So, pending possible future action by the FDA, consumers who choose to eat raw oysters should continue to be aware of the potential health hazards posed by these controversial mollusks. The Florida Department of Agriculture and Consumer Services provides the following tips on how to handle oysters safely:

BUYING, STORAGE AND HANDLING

Live Oysters: 

Remember to purchase seafood last and keep it cold during the trip home. 
Live oysters should close tightly when tapped.  
Discard any oysters that don't close; this is an indication that the shellfish are dead. 
They should have a mild odor, similar to the ocean. 
Live oysters should be free of cracks. 
They will remain alive for up to seven days in the refrigerator when stored at a constant 41 degrees F in a container with the lid slightly open.  
Drain excess liquid daily.

Shucked Oysters:  

Remember to purchase seafood last and keep it cold during the trip home. 
Oysters have a fresh odor when freshly shucked. 
A clear, slightly milky or gray liquid should surround freshly shucked oysters. 
Freshly shucked scallops should have very little liquid in the package 
Refrigerate shellfish in a sealed container on ice or in the coldest part of the refrigerator. 
Store shucked oysters up to five days.

PREPARATION

Keep raw and cooked seafood separate to prevent bacterial cross-contamination.  
After handling raw seafood thoroughly wash knives, cutting surfaces, sponges and your hands with hot soapy water.  
Always marinate seafood in the refrigerator.  
Discard marinade; it contains raw juices which may harbor bacteria.  
When marinade is needed for basting reserve a portion before adding raw seafood.

 COOKING

Wash live oysters thoroughly under cold running water prior to cooking.  
Steamed or grilled: cook until shell opens.  
Shucked oysters: bread and fry in oil for 3 to 4 minutes at 375 degrees F.  
Shucked oysters: bake for 10 minutes at 450 degrees F. [1]

REFERENCES:

[1]   "Oysters", Foodreference.com;
[2]   Vibrio vulnificus, Bad Bug Book: Foodborne Pathogenic Microorganisms and Natural Toxins Handbook, Centers for Disease Control and Prevention;
[3]   Vibrio vulnificus, General Information, Centers for Disease Control and Prevention;
[4]   Vibrio parahaemolyticus, General Information, Centers for Disease Control and Prevention;
[5]   Vibrio vulnificus Health Education Kit, U.S. Food and Drug Administration;
[6]   "Letter to Health Professionals Regarding the Risk of Vibrio vulnificus Septicemia Associated with the Consumption of Raw Oysters", U.S. Food and Drug Administration, June, 2005;
[7]   "FDA Investigating Norovirus Outbreak Linked to Oysters", FDA News Release, March 2, 2007;
[8]   "FDA Statement on Vibrio Vulnificus in Raw Oysters", FDA News Release, Nov. 13, 2009.

Clarification: A Section Renamed

dflynn@foodsafetynews.com (Dan Flynn) — Wed, 03 Feb 2010 01:59:05 -0800

Over the last few weeks, Food Safety News has received numerous inquiries related to our "Contributed Articles" section. This section is dedicated to featuring articles and opinion pieces written by authors from a wide variety of disciplines who are not on staff at Food Safety News.

While not all of the articles published in this section are traditional "Opinion" pieces, some certainly are. Because this may have been unclear to some, Food Safety News is putting a new label on this section. It is now called "Opinion & Contributed Articles."

We are making the change to make it clear that Opinion pieces presented here reflect strictly the opinion of the author and do not necessarily reflect the views of the Food Safety News staff or publisher.

Because people are passionate about a variety of food safety topics--from sustainability to traceability, and from raw milk to GMOs--we will continue to insist that contributing writers and readers who offer comments keep their discourse civil. We will not tolerate this forum eroding into a chorus slinging personal insults.

Our policy, which we don't want to change, is to approve comments so long as they are readable and not spam.

Keeping it civil really has not been much of a problem because the food safety community is used to keeping the debate on a high note.

But on occasion, we've drawn comments from people who don't respect this level of discourse nor do they understand that the purpose of this section is to provide a forum for voices not connected to Food Safety News.

Hopefully, this change will make things more clear. We do not want to get into the business of editing, deleting, or denying comments. But we will if we have to.

If you think an author missed the mark or have a conflicting viewpoint and would like to write an opposing Opinion piece for publication in Food Safety News, please contact us at info@foodsafetynews.com.

Should We Care About Genetically Modified Foods?

jnshaw@uark.edu (John N. Shaw) — Mon, 01 Feb 2010 01:59:03 -0800

Genetically modified foods have recently garnered more attention as the issue becomes a hotly debated and popular subject. Several environmental organizations and public interest groups have actively protested against Genetically Modified Foods (also, Genetically Modified Organisms or GMOs) for various reasons. The main question many have asked is, "should we support or oppose GMOs?"

Deborah Whitman sheds some light on this subject and does an excellent job summarizing the issues involving GM foods in her article "Genetically Modified Foods: Harmful or Helpful?" Whitman presents numerous advantages and criticisms for GMOs.

In my opinion, the advantages of GMOs versus the cons are overwhelming. Although some believe GM foods impinge on consumers' health, I believe this is de minimis--so small or minimal in difference that it does not matter. In order to understand my opinion on this issue, I submit that I am no scientist; merely an interested student.

Although GMOs are often the subject of controversy, a number of people do not understand exactly what they are and why their use is debated. GMOs are foods derived from genetically modified organisms. The term GMO is used to refer to crop plants created for human or animal consumption using the latest molecular biology techniques. These plants have been modified in the laboratory to enhance desired traits such as increased resistance to herbicides or improved nutritional content. The enhancement of desired traits has traditionally been undertaken through breeding, but conventional plant breeding methods can be very time-consuming and are often not very accurate. However, genetic engineering can create plants with the exact desired trait very rapidly and with great accuracy.

What are some advantages? Most advantages appear to be diminutive; however, they have an enormous impact on our society and food supply. Some of the advantages include pest resistance, herbicide tolerance, disease resistance, cold tolerance, drought tolerance, nutrition, and pharmaceuticals. These advantages are listed below in further detail:

Pest resistance can be extremely costly, requiring farmers to spend a lot of time and money on pesticides. Additionally, these pesticides bring about numerous hazards and can encroach on consumers' health. GMOs can help eliminate pesticides and reduce costs. These advantages can mean reduced costs for farmers that are eventually passed along to consumers. Further, crop losses from insect pests can be staggering, resulting in devastating financial loss for farmers and starvation in developing countries.
Another important advantage of GMOs is the fact that biologists are working to create plants with genetically engineered resistance to plant viruses, fungi, and bacteria. This would also help farmers and others be more efficient and save money.
An antifreeze gene has been introduced into several plants, giving the plants the ability to tolerate colder temperatures that normally would kill unmodified seedlings.
Researchers are working to create a strain of "golden" rice that contains several vitamins and nutrients. This is significant because it could improve the diet of populations dependent on rice while reducing malnutrition in countries that don't have access to other crops.
GMOs help lower costs for much needed medicines and vaccines that are too expensive for impoverished countries.

Although the advantages of GMOs seem to make the case for their use a "no brainer" at this point, there are several criticisms and concerns. Critics often include environmental activists, religious organizations, public interest groups, professional associations, and other scientists and government officials. Their main concerns are comprised of a belief that private corporations are pursuing profits without concern for potential hazards and a belief that the government is failing to exercise adequate regulatory oversight. Whitman states that GM food concerns generally fall into three categories: 1) environmental hazards, 2) human health risks, and 3) economic concerns.

The environmental hazards consist of unintended harm to other organisms. For example, a study showed that pollen from Bt corn, corn bioengineered to resist the European corn borer, a crop pest which can cause significant damage to crops, caused high mortality rates in monarch butterfly caterpillars. Although the killing of insects may be the goal in pest resistance, it flows into other unintended species. Additionally, some populations of mosquitoes and other insects may become resistant to crops that have been genetically modified.
Human health risks are an enormous concern. The main argument against GMOs is that there are several possible unknown risks. Two main concerns are that introducing foreign genes into food plants COULD have a negative impact on human health by introducing a new allergen or that ingesting these foods could cause problems with consumers' intestines. However, this is up for debate and critics claim that the concerns are not warranted.
The economic concerns, and probably the most warranted, claim that the process of bringing a GMO to the market is a lengthy and costly process in which companies pursue a profitable return on their investment. The problem occurs when companies patent these new plants and raise the price of seeds.

In conclusion, Genetically Modified foods have enormous potential to save money, eliminate poverty, reduce hunger and malnutrition, and promote innovative practices. Some individuals believe GM foods infringe on the environment and human health, however, I believe these concerns are de minimis and unwarranted. Although we must proceed with much caution and detailed research, technology is constantly pushing the boundaries of what's possible. Consumers should weigh the positives with the negatives and embrace this innovative process to help rid the world of numerous problems.

Additional references:

1. "GM corn poses little threat to monarch larvae" (Nature, Vol. 399, No 6733, p. 214, May 1999).
2. "Genetically Modified Foods: Harmful or Helpful?" Deborah B. Whitman, 2000.
Found at: http://www.csa.com/discoveryguides/gmfood/overview.php
3. FDA; Federal FD&C Act. See "http://www.fda.gov/NewsEvents/Testimony/ucm115032.htm"
4. http://www.healingdaily.com/detoxification-diet/genetically-engineered-foods.htm

FSIS Should Require Labeling for Tenderized Steaks

bmarler@marlerclark.com (Bill Marler) — Fri, 29 Jan 2010 01:59:03 -0800

On Christmas Eve 2009, the U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) announced that National Steak and Poultry was recalling 248,000 pounds of mechanically tenderized beef products contaminated with E. coli O157:H7.

Within days of the recall announcement, the Centers for Disease Control and Prevention confirmed that 21 people from 16 states had become infected with the outbreak strain of E. coli O157:H7 after eating the mechanically tenderized steaks. Public health agencies in Calif., Colo., Fla., Hawaii, Iowa, Ind., Kan., Mich., Minn., Nev., Ohio, Okla., S.D., Tenn., Utah, and Wash. reported that residents of their states had become ill with E. coli O157:H7 infections after eating the recalled steaks.

Last week, Marler Clark, filed a lawsuit against National Steak and Poultry in Utah on behalf of a 14-year-old boy who became infected with the outbreak strain of E. coli O157:H7 in October 2009. He was sick for weeks and hospitalized for several days.

Generally, it has been believed that steaks are not considered a high-risk source of E. coli O157: H7. However, when steaks are mechanically tenderized (also, blade-or needle-tenderized), that process introduces the possibility that bacteria from the surface of the meat can be transferred to the inside of the product. The mechanical tenderization of meat products like steaks and roasts involves a process of repeatedly inserting small needles or blades into the product. These needles or blades pierce the surface of the product, increasing the risk that any pathogens located on the surface of the product can be transferred to the interior of the product.

Since steaks are cooked to a wide range of internal temperatures, the insides of steaks often do not reach a temperature hot enough to kill E. coli bacteria. In essence, an undercooked mechanically tenderized steak poses a risk for E. coli O157:H7 contamination similar to that of an undercooked hamburger. That's why the USDA recommends cooking a mechanically tenderized steak to an internal temperature of 160 degrees--the same recommended internal temperature for a cooked hamburger.

Last June, food safety advocates from the Center for Foodborne Illness Research & Prevention, the Center for Science and the Public Interest, Consumer Federation of America, and Food & Water Watch, all key members of the Make Our Food Safe Coalition, sent a letter to Secretary of Agriculture Tom Vilsack, outlining the specific risks presented by "non-intact" or mechanically tenderized steaks.

The coalition urged USDA to require labeling on non-intact meat cuts and to educate consumers about the risks of under-cooking such meat products to minimize the risk to public health. They have not yet received a formal response from Vilsack or the USDA.

Advice from the Make Our Food Safe Coalition included the following, which FSIS should implement immediately:

Issue a press release as soon as possible indicating that the current cooking guidelines and temperatures for intact beef products are not safe for all beef products that look intact. [Specifically, that mechanically tenderized steaks should be cooked to an internal temperature of 160 degrees, just like hamburgers.]
Take immediate steps to develop regulation that will require labeling to clearly identify mechanically tenderized, non-intact beef and pork products for all processing facilities, retail purchasers, and consumers.
Initiate a FSIS program to assess the effectiveness of public health messaging, so that effective food safety messages can be delivered to all food safety stakeholders.

As the USDA is aware, the outbreak traced to National Steak and Poultry products is not the only E. coli outbreak traced to mechanically tenderized steaks in the last decade. There have been several others. It is time for USDA to implement steps to prevent more outbreaks like the following:

In Mar. 2003 six people developed E. coli O157:H7 infections after consuming steaks produced by Stampede Meat, Inc., of Chicago, Illinois. The steaks, which were later recalled, had been blade-tenderized and injected with marinade.

In Aug. 2004 patrons of a Colorado Applebee's restaurant became ill with E. coli O157:H7 infections after eating beef products produced by Quantum Foods of Bolingbrook, Ill. The firm recalled approximately 406,000 pounds of frozen beef products for potential E. coli O157:H7 contamination.

In May 2007 Davis Creek Meats and Seafood of Kalamazoo Michigan recalled nearly 130,000 pounds of beef products in 15 states because of possible E. coli O157:H7 contamination. The recalled boxes of mechanically tenderized steaks and ground beef were linked to E. coli O157:H7 illnesses.

In May 2007, an E. coli O157:H7 outbreak investigation by the Fresno County Department of Community Health revealed that tenderized, cooked tri-tip sold by The Grill at the Meat Market and served at several catered functions was the source of the outbreak.

In Sept. 2008 at least 24 attendees of a Forest Ranch, Calif. Fire Department fundraiser became ill with E. coli O157:H7 infections after eating tenderized tri-tip beef served at the event.

Several studies [as recently as 2009] have been undertaken to determine if the mechanical tenderization process transfers pathogens from the surface to the interior of beef products. A study by Luchansky et al., found that depending on the level of surface contamination, mechanical tenderization of beef products transferred E. coli O157:H7 into the topmost 1 cm of product in 90% to 100% of samples and into the topmost 2 cm of product in 55% to 98% of samples.

FSIS knows the risks and must act now to prevent future illnesses from tenderized steaks.

Food Safety's Biggest Challenge: The American Diet

bclark@marlerclark.com (Bruce Clark) — Wed, 27 Jan 2010 01:59:03 -0800

Americans are rightly concerned about the wide variety of pathogens that regularly turn up in foods common to most diets. Who wouldn't appropriately worry about an array of bugs that can induce serious short-term and even long-term health impacts from a wide spectrum of what Americans eat on a regular basis? But the bigger worry ought to be about the non-contaminated foods we build our diets around that have been implicated in many of the leading causes of death for Americans.

Dietary and lifestyle factors in the US are responsible for death rates that exceed most other Westernized countries. Primary preventable causes of death include: smoking (465,000 per year), hypertension (395,000), obesity (216,000), physical inactivity (191,000), high blood glucose levels (190,000), high levels of low-density lipoprotein cholesterol (113,000), and other dietary risk factors also mean that major changes in diet combined with changes in health care could make huge differences in our population's health.[1]

Indeed, four of the ten leading causes of death in the U.S., including the top 3, can be influenced by diet: coronary heart disease, cancer, stroke, and diabetes. Critical dietary factors associated with these conditions include those that are too high in calories, fat, saturated fat, cholesterol, and sodium or too low in fiber-containing foods.[2]

Diabetes treatment now costs over $100 billion annually, a figure that is projected to triple by 2034 to an annualized figure of $334 billion.[3] About 90% of those with diabetes have type 2 in which the pancreas produces insulin but the body becomes increasingly resistant to insulin's ability to break down glucose. A leading risk factor for type 2 diabetes is being overweight.

There is, of course, an ongoing torrent of specialty diets which often feature fundamentally opposing approaches to what constitutes healthy eating. For instance, the Atkins Diet focuses on consumption of high levels of protein and fat with few carbohydrates; the book The China Study insists that all animal protein is bad and that fruits and vegetables hold the key to a healthy life; while Gary Taubes's Good Calories, Bad Calories takes issue with the notion that fat is bad and places the blame for America's diet-related health maladies on the amount of refined carbohydrates we eat. This idea that refined carbohydrates (sugar, high fructose corn syrup, white flour, French fries) are particularly bad rests on research showing that they play havoc with the body's blood sugar (glucose) levels and provoke storage of excess fat. Another potential side effect of refined carbohydrate consumption is that it may actually increase feelings of hunger leading to a cycle of over consumption.

And if it sounds like a lot of your favorites are on the "eat less" list, consider that alcohol is another problematic consumable. The potential virtues of red wine aside, alcohol itself is devoid of nutrients. And while pure alcohol contains no carbohydrates (the sugars present in grain are consumed during distillation) it is highly caloric (7 calories per gram versus 4 calories per gram of carbohydrate). Alcohol is also preferentially metabolized and may slow normal fat metabolism. The intermediate byproduct of alcohol metabolism in the liver--acetaldehyde--is toxic and is associated with several types of cancer.

There are legions of Americans who assume they are avoiding the dangers of a diet featuring carbohydrates in the form of high fructose corn syrup by consuming vast quantities of diet drinks. Not so fast. An intriguing commentary in the Journal of the American Medical Association makes the case that while artificial sweeteners have the potential for at least short term weight loss when substituted for sugared foods, the long-term effects may be just the opposite.[4] This can occur due to the ability of intense sweeteners to:

...cause taste preferences to remain in, or revert to, an infantile state (ie, with limited tolerance for more complex tastes). Individuals who habitually consume artificial sweeteners may find more satiating but less intensely sweet foods (eg, fruit) less appealing and unsweet foods (eg, vegetables, legumes) less palatable, reducing overall diet quality in ways that might contribute to excessive weight gain.[5]

Of particular concern is the ability of diet drinks, consumed in the absence of other foods, to produce "a dissociation between sweet taste and calorie intake."[6] Limited research on rats suggests that this may disrupt hormonal and neurobiological pathways leading to long-term increased calorie consumption and weight gain. Long-term studies on humans are needed to "flesh out" this hypothesis.

Few of us probably sufficiently ascribe the quality of our diet to our basic state of health. And while it is very easy to become overwhelmed with the endless claims of various diets, there are a few truths that ought to inform how we eat: eating too much is bad and eating too much of certain things like highly refined carbohydrates is particularly bad. A diet high in saturated fat and cholesterol is not good; a diet high in non-starchy vegetables is good, as is one that features whole grains and lean proteins. Moderation in all things is very good.

And so as 2010 unfolds, take time to consider the fundamentals of your diet and the critical food safety issue it represents. Contaminated foods can certainly result in very serious illness, but a good diet can help ensure long-term health.

1. Danaei G, Ding EL, Mozaffarian D, et al. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med 2009;6:e1000058-e1000058.
2. Frazão, E., The American Diet: A Costly Health Problem FoodReview (202) 219-0911(1996).
3. Huang, ES et al. Projecting the Future Diabetes Population Size and Related Costs for the U.S. DIABETES CARE December 2009 vol. 32 no. 12: 2225-2229.
4. Ludwig DS, Artificially Sweetened Beverages Cause for Concern. JAMA. 2009;302(22):2477-2478.
5. Id.
6. Id.