Senate Bill 510, since introduced, has been controversial amongst many in the local food movement.  Many of the bill’s vocal opponents have stated that S. 510’s new Hazard Analysis and Risk-Based Preventive Controls, traceback, and produce safety requirements, if passed, will result in a crushing blow to the sustainability of small farms.  Some extremist websites have even gone as far as to publish headlines claiming that “Senate Bill S. 510 Makes it illegal to Grow, Share, Trade or Sell Homegrown Food, or Even to Produce Your Own Food.”  For the most part, however, it appears that a good number of small farmers will support S. 510, as long as it includes the Tester amendments.  Whether consumers should support the amendments is a whole different story.

The first of Senator Tester’s amendments excludes facilities that have an average annual adjusted gross income for the previous three-year period of less than $500,000 from federal Hazard Analysis and Risk-Based Preventive Controls (Section 418) regulations, deferring to state law.  From the consumer’s standpoint, this is perhaps the least worrisome of the three proposed amendments.  While all farms should be required to develop and maintain preventive controls, a one size fits all approach does not seem appropriate.  Add to that the fact that Section 418 does not limit the FDA’s authority to issue category-specific HACCP plans (See pg. 137, line 3), and it would seem that, even if small farms are exempt, the federal government will still be able to require safety plans for particularly hazardous categories of food, regardless of the facility’s income.

Even though Senator Tester’s amendment to Section 418 appears to be the least worrisome of his proposed actions, it is not without its faults.  The primary risk associated with allowing Hazard Analysis and Risk-Based Preventive Controls regulations to be dictated by state law is the piecemeal basis on which they will be assembled.  Laws can vary significantly from state to state; this is especially dangerous when coupled with the fact that Senator Tester’s amendment to Section 418 mentions nothing about food products that are shipped across state lines.  By adopting Senator Testor’s amendments, the federal government would essentially forgo an opportunity to adopt a national standard for Hazard Analysis and Risk-Based Preventive Controls.  The end result is that consumers will walk into their local grocery stores and not know whether the produce that they are purchasing came from a state with strict preventive controls requirements or not.  Perhaps some might see this as an argument in favor of shopping at farmer’s markets, but it is irresponsible to ignore the fact that the majority of this nation’s citizens purchase their food from large supermarkets and deserve to be assured of the safety of that food.

The second provision of Senator Tester’s amendments limits recordkeeping requirements for facilities that have an average annual adjusted gross income for the previous three-year period of less than $500,000.  Specifically, the amendment requires only that records be kept for transactions with a qualifying facility’s immediate suppliers and immediate subsequent recipients.  This amendment would result in an enormous setback in the push for national traceability requirements.  As previously discussed on Food Safety News, the $500,000 cutoff would exempt nearly 95 percent of all domestic farms from S. 510’s stricter traceability standards, virtually eliminating the effectiveness of the new requirements.  Unfortunately, as many in the food safety industry well know, delays in traceback efforts can often lead to many unfortunate illnesses and deaths during foodborne illness outbreaks.

The final provision of Senator Tester’s amendments excludes facilities from S. 510’s produce safety requirements if the qualifying facility’s annual value of sales of food directly to consumers, hotels, restaurants, or institutions exceeds the annual value of sales of food to all other buyers.  The specific provision which this amendment addresses, Section 419, requires proposed rulemaking “to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.”  This provision is one of the most straightforward measures in the entire Senate bill; why small farmers should be exempt from updated produce safety procedures is beyond me.

The primary argument that I have thus far seen raised against Section 419 is that the public hearing requirements (“not fewer than three public meetings in diverse geographical areas of the United States”) are too limited and may occur during harvest season.  This argument fails to acknowledge the fact that the federal government is required, under the Administrative Procedures Act (APA), to allow for the “submission of written data, views, or arguments.”  (See U.S.C. § 553(c)).  Oral presentations, such as those invited by the public meetings, are not required under the APA and are offered as a mere courtesy.  Thus, if a rule is proposed pursuant to Section 419, any member of the public will be allowed to submit written comments at his or her own convenience.

While small farmers should be legitimately concerned with some of the one size fits all proposals contained in Senate Bill 510, changes to the bill should not come at the expense of consumer safety.  Senator Tester’s amendments, therefore, need more thought and retooling before the Senate should consider incorporating them into the final bill.  Additionally, the Senate should be quite weary of the commonly held misconception that small farms are inherently safe.  To quote Senator Tester himself, “Let’s face it, dangerous food-borne outbreaks don’t start with family agriculture.”  Small farms are not inherently safe simply by virtue of their diminutive size.  Case in point was the 2006 E. coli O157:H7 spinach outbreak.  That outbreak, which resulted in 205 illnesses and 3 deaths and spanned 26 states, was caused by spinach that was grown in one field on a 50-acre farm in San Benito County, California.  The danger of such an incident happening again is very real, and so it remains that exempting small farms from risk prevention, traceability, and produce safety requirements is not the answer.

I say all of this as an ardent supporter of the local food movement.  Local growers must never lose sight of the fact that their responsibilities are to their consumers.  Those consumers deserve to be assured that all of the food that they purchase is held to a stringent national safety and traceability standard.

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.

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.

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 approa
ch 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.

Sadly, this recent scare is only one in a long line of contaminated milk controversies in China.  In 2008, over 294,000 infants were sickened or killed after consuming tainted powdered milk.  (For an in depth look at the 2008 melamine scare, you can read my earlier report here)  The 2008 outbreak was prompted by companies that deliberately poisoned their product in order to generate falsely inflated protein content results.  The only reason such protein tests were required in the first place was because of earlier problems with companies that were diluting their product, thus lessening production costs.  Oh yeah, the diluted product happened to cause the small side effect of malnutrition, leading to the deaths of children who consumed the milk.  Apparently such side effects are no big deal in the world of Chinese business.

So what thread binds all of the previous Chinese milk scares together?  The answer is simple: corporate greed.  Reports are still inconclusive as to whether the latest melamine scandal was motivated by a company looking to make a profit at any cost, however, as reported by the Wall Street Journal, it appears likely that the latest disaster was masked for the better part of a year by a large-scale industry cover-up.  

On Tuesday, a Chinese newspaper reported that milk industry representatives may have known about the Shanghai Panda melamine contamination as early as April 2009.  It even appears, according to one insider, that the Chinese government had looked into the production practices at Shanghai Panda as early as September 2009.  This, unfortunately, parallels the string of delays and cover-ups associated with the 2008 contamination scandal, which at the time led to tens of thousands of additional illnesses.

Despite the breaking international news surrounding this latest melamine scandal, the Chinese government has been slow to respond to questions.  It is unknown, as of yet, whether any Chinese citizens were injured by consuming the tainted milk.

After over a year of following these scandals, it’s tough not to be cynical about the state of Chinese business regulations.  After all, melamine contamination was said to be a thing of the past after the government enacted new food safety laws on June 1, 2009.  Two men were even executed for their roles in the 2008 scandal.  Still, at the end of the day, it seems that greed rules the game in Chinese business.  Apparently, no amount of scare tactics or unenforced legislation is going stop these companies from taking advantage of a system that allows them to function with essentially no oversight.  Sadly, the cost of Chinese corporate greed is being borne by the children who consume these products.   For Chinese milk companies, dead and injured children are just another expense of doing business.

Once every few years, Consumer Reports conducts a national study on the safety of store-bought whole chickens.  To do this, the magazine purchases various brands of whole broiler chickens from stores across the country and sends them to a laboratory that tests the chickens for Salmonella and Campylobacter bacteria.  The magazine’s 2007 study was, at the time, the most extensive national survey of contamination and antibiotic resistance in store-bought chicken ever published.  That study tested 525 fresh chickens from stores across 23 states, and included 10 organic and 12 nonorganic brands.  The most recent study, the results of which are discussed in the magazine’s January 2010 issue, tested 382 chickens from more than 100 stores across 22 states.  Both studies reached a similar conclusion: the majority of whole chickens sold in stores across the United States are contaminated with potentially deadly bacteria, and the government isn’t doing enough to fix the problem.

The consequences of lax governmental regulations, especially pertaining to Campylobacter, were readily apparent throughout the studies.  From 2003 to 2007, the percentage of chickens contaminated with either Salmonella or Campylobacter, or both, rose sharply, from 49 percent in 2003 to 83 percent in 2007.  By 2010, the number decreased to 66 percent.  Even though the recent numbers showed a slight decline, the fact that studies have shown that two thirds of our nation’s chickens are contaminated with Salmonella or Campylobacter is not reassuring news.  

Perhaps more frightening, the studies revealed that the majority of the bacteria found in store-bought whole chickens are resistant to one or more antibiotics.  The 2010 study indicated that 68 percent of all Salmonella reported, and 60 percent of Campylobacter, were antibiotic-resistant.  This establishes the sobering reality that current treatments for persons infected with these bacteria may soon be rendered obsolete if the government and producers do not act quickly to curb the rampant spread of antibiotic-resistant strains.

Throughout the studies, some brands performed better than others.  In 2007, it was found that premium brands labeled organic or raised without antibiotics and costing anywhere from $3 to $5 per pound, were in fact more likely to contain Salmonella than brands raised conventionally and costing $1 per pound.  The 2010 study, however, found that two major brands, Tyson and Foster Farms, yielded positive results for pathogens in over 80 percent of chickens tested.  Of the major brands tested in 2010, Purdue fared the best, with 56 percent of chickens testing free of both pathogens.

Although, in the studies, Salmonella numbers seem to be somewhat stabilized (albeit, at a much too high rate), the rate of Campylobacter contamination is spiraling out of control.  The 2007 study found Campylobacter in a stunning 81 percent of all birds tested.  In 2010, the number diminished to 62 percent.  Regardless, this is an unacceptable result and shows that stricter standards for Campylobacter must be implemented if there is ever to be any hope of ridding chicken of this pathogen.

The studies were not without bits of promising news.  The studies showed that air-chilling, a technique whereby chicken carcasses travel along a long track where they are misted, cooled with air, and then submerged in an antimicrobial bath, may yield at least some beneficial results.  In 2010, air-chilled broilers showed slightly improved numbers over conventionally handled birds, with about 40 percent testing positive for one or both pathogens.  

When considering all these numbers, it is important to remember that as few as 15 Salmonella and as few as 400 Campylobacter organisms can make you ill.  The USDA needs to implement testing standards for Campylobacter and establish harsher penalties for Salmonella contamination.   Moreover, the rampant problem of antibiotic resistance is creating a category of fortified pathogens that could easily lead to more serious illnesses and deaths if something is not done to address this issue.  

Obviously, everyone needs to ensure that the chicken they purchase is cooked to an appropriate temperature.  Still, I don’t feel safe knowing that one small slip-up will likely lead to cross-contamination with Salmonella or Campylobacter, no matter what brand of chicken I buy.  Someone needs to hold the chicken industry accountable for these appalling numbers.

In 2006, eighteen members of the Salem Lutheran Church in Longville, Minnesota became desperately ill after eating E. coli O157:H7-contaminated meatballs at a church potluck.  Due to their infections, one member died and another experienced acute kidney failure.  The victims of the outbreak subsequently filed a law suit against the makers and the sellers of the ground beef.  A year later, one of the defendants in the case, Nebraska Beef, filed a third-party complaint against the church in an attempt to place the blame for the illnesses on the victims.  The complaint specifically alleged that “the damages sustained by the Plaintiff[s], if any, [were] the direct and proximate result of the negligence and/or other fault for tortuous conduct of Third-Party Defendant Salem Lutheran Church.”

From a public relations standpoint, Nebraska Beef’s lawsuit against the church-goers was a complete disaster.  On June 8, 2008, the New York Times ran an article about Nebraska Beef’s legal maneuver entitled “Out of a Church Kitchen and Into the Courts.”  (http://www.nytimes.com/2008/06/08/business/08feed.html).  The article pointed out that the members of the Salem Lutheran Church were being blamed for their illnesses, despite the fact that the Minnesota Department of Health had stated that, in all likelihood, the ground beef used to make the meatballs was contaminated well before it was purchased by the church members.  

The “volunteer church ladies,” as they were referred to in the article, took the same precautions while cooking the raw meat that most people would take.  To determine whether the meat was properly cooked, the church members had cut a few meatballs open to visually inspect the color of the inside.  They had not, however, used a meat thermometer to ensure that the internal temperature had reached 160 degrees.

So, aside from the obviously bad PR that results from suing a church, what was wrong with Nebraska Beef’s decision to sue the victims?  Isn’t the victim of an E. coli O157:H7 infection always to blame if she gets sick because she didn’t use a meat thermometer?  This can be a touchy issue, especially in situations like the Salem Lutheran Church case where the injuries suffered proved to be fatal.  It’s also an issue that comes up fairly often in cases of foodborne illness.  

This issue begs one fundamental question: What constitutes “proper” cooking of ground beef?  After all, even if meat is contaminated, heat of a certain temperature will kill the harmful bacteria.  Should it matter that the beef was contaminated before it reached the consumer?  On the other hand, aren’t there people who prefer their ground beef rare or medium-rare?  Is a “rare” burger properly cooked, even though the internal temperature may not have reached 160 degrees?  Therein lies the quandary: “proper” cooking of meat is, and always was, a reference to visual appearance and texture, not to temperature.    

The issue of proper cooking of ground beef became so fundamental in foodborne illness litigation that, in 1994, a federal court squarely addressed it in the case of Texas Food Industry Ass’n, et al. v. Espy.  In Espy, several supermarket and meat industry organizations sought an injunction against the USDA, attempting to prevent the agency from declaring E. coli O157:H7 an adulterant, and barring it from implementing an E. coli sampling program.  In denying the injunction, the court cited several reasons for allowing the USDA to declare E. coli O157:H7 an adulterant, one of which was the public’s perception of “proper” cooking of ground beef.  In its holding, the court stated:

[U]nlike other pathogens, it is not “proper” cooking but “thorough” cooking that is necessary to protect consumers from E. coli.  The evidence submitted by Defendants indicates that many Americans consider ground beef to be properly cooked rare, medium rare, or medium.  The evidence also indicated that E. coli contaminated ground beef cooked in such a manner may cause serious physical problems, including death.  Therefore, E. coli is a substance that renders “injurious to health” what many Americans believe to be properly cooked ground beef.

In allowing the USDA to declare E. coli O157:H7 an adulterant, the Espy court recognized the danger of the deadly bacteria and allowed the USDA to institute a zero-tolerance policy regarding the pathogen.  The nuanced discussion of proper cooking admitted a fact that the court knew just as well as everyone else: very few people regard cooking a hamburger as an exact science.  A consumer can walk into nearly any restaurant in this country and order a hamburger that is cooked rare.  In such a case, chances are slim to none that the restaurant kitchen staff carefully checked the internal temperature of the patty with a meat thermometer prior to serving the burger to their customers.

Despite the fact that a federal court has recognized the difficultly in saying that consumers should be able to mitigate the danger of tainted meat through “proper” cooking, I understand that some “blame the consumer” advocates may still disagree with the title of this article.  To those persons, perhaps it’s better to approach this dilemma not by looking at the consumer’s actions, but by looking at a manufacturer’s legal duties.

The first step towards understanding the duties of a ground beef manufacturer is to establish a baseline that I think that everyone can agree on: ground beef that contains E. coli O157:H7 is a defective product.  The USDA established as much when they declared E. coli O157:H7 an adulterant under federal law in 1994.  It makes sense from an intuitive standpoint as well.  A large meat company, such as Nebraska Beef, does not have a drawing room where they create blueprints detailing how to make ground beef patties that contain E coli O157:H7.  To the contrary, such companies spend a great deal of time and money calculating how to ensure that their products do not contain bacteria.  In other words, Nebraska Beef does not design their beef products to contain E. coli O157:H7, thus, any ground beef product that does contain the bacteria is deemed defective, both under internal standards and federal standards.

An understanding that ground beef that contains E. coli O157:H7 is defective is a key to realizing why Nebraska Beef’s attempt to shift blame to the Salem Lutheran Church was a moot point.  The law does not look kindly upon manufacturers of defective products that cause injuries to consumers.  Since the late 1800s, the American legal system has recognized that manufacturers of certain products are strictly liable for injuries resulting from the proper use of the products.  Strict liability means that the manufacturer will be held responsible for damage caused by their defective product, regardless of whether they put proper care into making the product.  Thus, if a meat company sells ground beef that contains a deadly pathogen, and that pathogen causes injuries to the purchaser of the ground beef, the meat company is
liable, even if they tried
their best to make sure the meat didn’t contain any harmful bacteria.

The concept of strict liability for manufacturers of defective products can perhaps be more easily understood with a quick analogy.  Let’s say an automaker sells a brand new, perfectly fine looking car to a loyal customer.  Unfortunately for the customer, there is a hairline crack in steering axle that has been there since the car was assembled.  When the car was sold, the manufacturer didn’t know the crack was there, nor did the dealer or the customer.  The customer drives the car off of the lot and onto the freeway.  Ten minutes later, as the car rounds a turn, the axle breaks, sending the car careening out of control and off a cliff.  Who’s liable?  Well in that case, it seems pretty intuitive.  The customer could not have been expected to inspect every inch of the car before he bought it, therefore the law says that the manufacturer is liable for the customer’s injuries, regardless of the fact that it didn’t mean to install a faulty steering axle.

The law treats manufacturers of beef products no differently than it treats the car manufacturer in the above example.  So long as a customer has not substantially altered a product and is using the product in the way that it was intended to be used (in the case of ground beef, cooking it and eating it), the manufacturer will be liable for the harm caused by any defects–whether the defect was a faulty axle or deadly bacteria.

With these examples in mind, we can finally tell the whole story of the volunteer church ladies from Salem Lutheran Church and understand why they were not to blame for their own injuries.  Nebraska Beef manufactured a product that the Minnesota Department of Health said, in all likelihood, was contaminated with E. coli O157:H7.  The federal government has recognized the danger of E. coli O157:H7, and has accordingly instituted a zero-tolerance policy for ground beef that contains the bacteria.  Nevertheless, the defective beef eluded inspectors and was sold to the church members.  The volunteer church members then formed the beef into meatballs and cooked it, using the meat in the normal manner in which one would use such a product.  They even visually checked the “doneness” of the product after cooking it.  When the members subsequently fell ill, Nebraska Beef became liable for the full costs of the emotional and physical injuries that resulted because they shipped a poisoned product, plain and simple.  

In short, were it not for Nebraska Beef’s sale of defective ground beef, the members of the Salem Lutheran Church would not have suffered the injuries that they did, regardless of the cooking techniques that they employed.

As is the case with any abbreviated summary of the law, there are about a thousand nuances that were left out of the above discussion.  The two primary concepts, however, still ring true: (1) the USDA has a zero-tolerance policy for E. coli O157:H7 in ground beef, and (2) companies that manufacture defective products are liable for the injuries caused by the use of their products.  To be certain, these concepts should not encourage consumers to abandon all safety precautions.  Indeed, many states allow a jury to apportion a percentage of fault to a plaintiff, sometimes even nullifying the plaintiff’s claim if they are found even one percent at fault.  More importantly, however, a purchaser of ground beef should always follow cooking procedures that are designed to kill any harmful bacteria.  (For more on proper cooking procedures, see https://www.foodsafetynews.com/2009/08/ground-beef-the-importance-of-safe-handling-practices-and-accurate-final-product-temperature/).  

Mitigating factors aside, it is crucial that the American public recognizes that the victim is never to blame when he or she is injured by a defect in a product that was used for its normal purpose and that looked perfectly fine.  The public must recognize this out of respect to the victims, such as the members of the Salem Lutheran Church in Longville, Minnesota, and in recognition of the over one hundred years of case law that shaped this concept in the American legal system.  

Naysayers and cynics will always argue that companies should not be held responsible for the subsequent use of their products.  They’ll argue that there is no way a company can possibly make all products completely safe.  They’ll also argue that companies shouldn’t be held liable to pay for injuries suffered by only a tiny percentage of their customers.  To them I only have this to say: when you are injured because your steering axle has a hairline crack or because your food contains deadly pathogens, the rest of us will remember exactly who to blame.  I’m sure you’ll gladly take your injuries in stride.  After all, as I know you’ll remind us, if you would have been just a bit more careful, you wouldn’t have been harmed by those defective products, right? 

“Maybe I’m naïve about the inner workings of the legislative process.”  

“After all, I’m still a fresh-faced-recent-law-school-graduate.  What do I know about creating meaningful legislation that will change the American food supply for the better?”

These were all thoughts that danced through my head as I set out to create a realistic picture of the effectiveness of the food safety bills currently in the House and Senate.  The stated goal of these bills is to “amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.”  One should hope that our legislators’ plan is at least to amend the existing law for the better.  Semantics aside, while I do believe that our congress men and women are legitimately concerned with the safety of our food, I fear that delays, workarounds, and politics as usual may prevent these bills, if enacted, from generating the safe food supply that we deserve.

I began my analysis of the bills’ effectiveness with Senate Bill 510, the FDA Food Safety Modernization Act.  (Note: this article pertains to the pre-Senate markup version of the bill.)  After reading the bill multiple times, I began to wonder just how soon we might see actual changes, overhauls, and improvements to the FDA if the bill is signed into law.  After all, a bill, even with the best intentions, cannot effect change if the provisions it contains offer no clear timelines.  

A slight digression: contrary to what some who aren’t familiar with the political process might believe, laws generally do not go into effect as soon as a bill is signed.  Some provisions might offer a clear enforcement timeline, say, six months, for example.  Other provisions, however, may appear to offer a timeline, but in reality offer a mere promise to think about a reform at some point in the future.  These latter provisions usually require an agency to propose an administrative rule, a process that could take years to complete and may yield final results that are much less sweeping than the original proposed rule.

With this in mind, I did a quick survey of S. 510, attempting to figure out how soon each provision might become effective if the bill was signed into law today.  What I ended up with was a table of the general timeline under which we will see results from each provision.

I divided the table into three time categories: (1) provisions that will become effective immediately after the bill is signed; (2) provisions that may take up to a year or more to become effective; and (3) provisions with no definite timeline attached.  One caveat: this was by no means a scientific study.  Some provisions contain specific elements that will go into effect at varying times.  The table does, however, provide a general overview of timelines within the bill.  That being said, let’s move on to the figures.  It will greatly help if you follow along with the table as you read the rest of the article.

The final distribution between the 30 provisions of the bill was as follows: 11 provisions go into effect immediately; 11 provisions go into effect within a year or more; and 8 provisions have no definite timeline attached.  

The provisions that go into effect immediately are typically somewhat subtle rewordings of current law.  For example, Section 101 gives the Secretary greater deference to order records inspections based on his or her reasonable belief that food items related to a product associated with an outbreak present a health threat.  This is in contrast to the current wording which limits the authority solely to the type of food thought to be directly associated with the outbreak.    

The provisions that go into effect within a year or more typically involve slightly more sweeping changes than the provisions that are effective immediately.  Examples of these changes include new performance standards and the foreign supplier verification program.  These provisions typically allow for a one to two year window before they are required to be implemented.  This, of course, is understandable due to the need to plan the changes and to allow industry time to budget and adjust.

The final set of provisions, those that have no timeline attached, are the ones that we must take with a grain of salt.  The reason for this has more to do with the procedures of administrative law than it does with Congressional intent.  When a federal agency–the FDA in this case–promulgates any administrative rule, the agency must follow the Administrative Procedure Act, which states that the agency must go through a specific notice procedure and allow for public comment.  This process, although established to keep the public informed and allow for public participation in the rulemaking process, dramatically lengthens the time span associated with establishing a new rule.  It may also serve to alter proposed rules from their original form.  For these reasons, the provisions of S. 510 that call for proposed rulemaking really offer no clear timeline for implementation, nor do they even guarantee that the final rule will mirror that which is proposed in the Act.  

Even more tenuous, other provisions with no timeline simply call for reports to Congress with no clear directive for legislation.

It is worth noting that a few sections of S. 510, despite offering clear timelines, do not guarantee that any actual food safety measures will be enacted.  Section 204 implements a traceback and recordkeeping pilot program that is simply to be followed by a report to Congress and proposed rulemaking.  Similarly, Section 205 just calls for a review of surveillance capacities with no proactive directives.

Where does all of this talk of timelines leave us?  Am I just being too critical of the Food Safety Modernization Act?  After all, change doesn’t happen overnight.  I think my cynicism about the effectiveness of these bills has its roots in my belief that most of these changes are long overdue.  Don’t get me wrong–there are surely provisions within S. 510 that show a strong desire for change.  Take Section 201 for example, entitled “Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report.”  This provision specifically states:

Beginning on the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall increase the frequency of inspection of all facilities.

That single sentence really struck me.  For once, in this 119 page mess of bureaucratic language, most of it too cumbersome to hold any non-industry person’s attention, there is a single very clear directive.  Maybe, just maybe, if the entire bill was authored with such clear objectives, based on non-ambiguous timelines, skeptics like me would regain just a bit of faith in the legislative process.  

Call me an idealist, but the strategy of generating sweeping change and making it resonate through simple, direct language is a tried and true political tactic.  If anything, it would at least make me, and many of the other 299,999,999 members of the American general public, feel just a bit more assured that the people in charge were doing all they could to make our food safer right
now, instead of years down
the line.  In the end, isn’t that worth it?

Speaking on behalf of his constituents, Mr. Boyle assured consumers that all meat products are safe to eat.  In an October 7, 2009 letter to the New York Times editor, Mr. Boyle claimed that the meat industry was doing all it could to make the food supply safer.  To this end he stated, “AMI submitted a petition five years ago to use carcass irradiation–a process to reduce or eliminate pathogens like E. coli–but we are still waiting for the department to initiate a rulemaking on its efficacy.”  What’s that?  Those pesky bureaucrats in Washington, DC were the ones standing in the way of progress this whole time?  Typical!  

Following the New York Times letter, Mr. Boyle repeatedly referred to AMI’s apparently failed attempt to petition the United States Department of Agriculture (USDA) to allow carcass irradiation.  During an October 12, 2009 appearance on Larry King Live, he stated, “five years ago, the American Meat Institute petitioned USDA to allow us to use irradiation on the exterior carcasses.  Five years later, the department has yet to commence a rule making to determine if we can utilize that technology.”

With all this talk about AMI’s interest in irradiation and protecting the public, I decided to read Mr. Boyle’s oft-discussed petition (pdf) myself.  After securing a copy of the petition, I reached the perhaps not surprising conclusion that Mr. Boyle has been trying to play an old fashioned game of bait and switch with the American public.  As it turns out, the petition was not a plea to the federal government to allow carcass irradiation.  In fact, as the document points out, the USDA Food Safety and Inspection Service (FSIS) has allowed meat producers to irradiate refrigerated or frozen uncooked meat, meat byproducts, and certain other meat food products since December 1999.  (See http://www.fsis.usda.gov/Oa/background/irrad_final.htm).  Indeed, to quote the petition, “the question is not whether [irradiation] of the chilled carcasses is consistent with the [USDA] regulations; it is.”

So, if the AMI petition doesn’t argue that the USDA is impairing meat producers’ ability to irradiate their products, what exactly does it argue?  Well, again quoting the petition, “the question is whether this low dose, low-penetrating application of [irradiation] to the outermost surface of the carcass needs to appear on the labels of meat derived from the carcasses” (emphasis added).  This can’t be though, can it?  Why would Mr. Boyle repeatedly cite a petition that states that meat producers are already allowed to irradiate their products and instead focuses on labeling requirements?  The answer to that question becomes clear after a quick analysis of the eight page AMI petition.

The petition appears to start clearly enough.  The subject line states “Re: Citizens Petition To Recognize the Use of E-Beam on Carcasses as a Processing Aid.”  Those last two words, however, indicate the actual purpose of the document.  According to FSIS, “processing aids” are defined as:

Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

That’s all well and good, but what does that have to do with AMI’s objectives regarding irradiation?  The answer is fairly simple: the USDA does not require processing aids to be listed on a food product’s ingredients statement.  AMI’s apparent goal in submitting the petition was to enable meat producers to irradiate their products without informing consumers.  This fact is emphasized later in the petition when AMI directly requests that FSIS “officially recognizes low dose, low-penetration electron beam (e-beam) applied to the surface of chilled beef carcasses as a ‘processing aid’ and accordingly that this process need not be labeled on any products derived from the carcass” (emphasis added).

Why am I making such a big fuss about this?  Surely, AMI is allowed to petition FSIS to do anything they want.  Add to that the fact that FSIS determines whether a practice is a “processing aid” on a case by case basis, and not only was AMI was clearly within its rights to write the petition, but the petition was, in fact, a necessary component of the administrative action AMI was seeking.  That being said, the real issue here is not AMI’s petition.  Nor is it FSIS’s rulemaking process.  The issue is AMI’s deceptive use of the petition on a national stage.  

FSIS waded through a great deal of public scrutiny before establishing the final rule on meat product irradiation in December 1999.  The agency received more than 1,100 public comments in response to an earlier proposed version of the rule.  The main issue in contention for many concerned citizens was their right to be informed about how the goods they were buying were made.  Consumers, they argued, must be free to choose whether the meat they buy is irradiated.  To this end, they fought arduously for strict labeling requirements.  Under the final rule, irradiated products were required to bear labels that displayed a special logo, as well as a statement such as “treated with radiation” or “treated by irradiation.”  These labeling requirements were a key component of the irradiation rule; without these requirements, the rule would likely not have been approved.

Patrick Boyle’s repeated assertion that FSIS “has yet to commence a rule making to determine if we can utilize [irradiation]” was misleading at best.  In the grand scheme of things, an industry spokesperson’s attempt to shift a bit of blame off the backs of the companies he represents is not surprising.  What makes Mr. Boyle’s comments interesting, however, is the fact that he’s pointing to a petition that was designed not to protect consumers, but rather to keep consumers uniformed by eliminating certain labeling requirements.  And he’s doing this in an attempt to remove some of the onus for Stephanie Smith’s suffering off of the meat industry.  We’ve already heard about Mr. Boyle’s misleading use of statistics and about his outlandish claims that E. coli in raw meat is “natural”, so it would seem that this is just another small lie in a series of deceptions.  At some point though, if Mr. Boyle continues to follow this path, consumers may decide that the mistruths contained in his arguments are almost as scary as the tainted meat disasters from which he’s been trying to divert the public’s attention.  

It’s not an easy time to be a meat producer, indeed.

Vehicular homicide is one of many crimes with a central tenant that any person who acts with such little regard for the wellbeing of those around them that their actions cause the untimely death of another person deserves to be punished to the full extent of the law.  With this in mind, what punishment do you suppose is befitting of a person who, through his or her blatant disregard for the safety of others, releases upon the public a product that kills nine persons and sickens hundreds?  The answer to that question depends on what country you’re in.  Here’s a hint though: you do not want to be the head of a company that sells a deadly product in China.

Working in the world of foodborne illness law, you get to see a lot of examples of producers that ignore safety in the name of profits.  Some of these examples, however, are more blatant than others.  On January 29, 2009, the Food and Drug Administration (FDA) pegged Peanut Corporation of America (PCA) as the source of a massive Salmonella Typhimurium outbreak.  What made the PCA outbreak particularly noteworthy was the huge number of products involved in the recall (2,100) and the disastrous nation-wide health consequences resulting from the tainted products (714 confirmed infections and 9 deaths).  The investigation following the outbreak revealed evidence of conditions unsanitary to a degree that would likely make Upton Sinclair turn in his grave.  The most egregious findings from the investigation, however, came not from production facilities riddled with rat feces, but from internal communications that illustrated knowledge of shipping contaminated products that could be traced all the way to PCA owner Stewart Parnell.

In an e-mail dated October 6, 2008, Mr. Parnell complained to Blakely, Georgia PCA plant manager, Sammy Lightsey, that positive Salmonella results were “costing us huge $$$$$ and causing obviously a huge lapse in time from the time we pick up peanuts until the time we can invoice.”  In the same e-mail, Mr. Parnell stated, “we need to protect our self [sic] and the problem is that the tests absolutely give us no protection.”

Subsequent statements from Michelle Pronto, the microbiology manager of the lab that warned PCA of dangerous test results, indicated that Mr. Lightsey “confirmed that because of high coliform results they were going to send samples to a different lab for a while.”  Ms. Pronto further indicated that her lab “did not receive any samples labeled ‘PCA’ between 8/26/08 and 11/24/08.”  Additional evidence indicated that Mr. Parnell begged the FDA to allow PCA to continue shipping peanuts even after the FDA identified PCA’s Georgia plant as the source of the Salmonella outbreak.

In light of the fact that Mr. Parnell and Mr. Lightsey wanted to continue with business as usual, even though their products were dangerously contaminated, and the fact that those practices resulted in hundreds of illnesses and nine deaths, criminal charges in this case seem more than apt.  And yet, to this day we have yet to see a single PCA employee or shareholder prosecuted.  It is not as if there are no laws applicable to this situation.  Under federal law, it is a felony to adulterate or misbrand food and put it into interstate commerce.  A person who commits such an act “with the intent to defraud or mislead” is guilty of a felony punishable by three years imprisonment.

Under the same federal law, a person may be convicted of a misdemeanor without a showing by the prosecution of fraudulent intent, or even a showing of knowing or willful conduct.  Instead, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.   Convictions under the misdemeanor provisions are punishable by up to one year imprisonment or a $1,000 fine.

In cases involving food adulteration or misbranding, individuals can be named as defendants along with corporate entities through which crimes were committed.  (See http://www.justice.gov/civil/ocl/monograph/fdca.htm).    Individuals named in such cases are usually high ranking officials who were in charge of the decision-making process that led to a violation of the law, as well as those persons who were actively involved in fraudulent activity. As a result, the presidents of corporations and the managers of the facilities where violations took place are often proper defendants.

These laws indicate that sellers of tainted food in America may at least be subject to some criminal penalties, but such laws don’t hold a candle to the criminal penalties executives of Chinese companies have faced in similarly egregious matters.

On September 16, 2008, a Chinese powdered milk company accused of selling poisoned product that left nearly 300,000 children ill fired its general manager and board chairwoman Tian Wenhua.  That same day, Communist party officials from Hebei Province removed Ms. Tian from her position as secretary of the corporation committee of the Communist Party of China.  The next day, Ms. Tian was formally charged with producing toxic food, a criminal charge punishable by up to life imprisonment or death.

By September 18, six days after the official announcement of the crisis, Chinese police had already arrested 18 people in connection with the powdered milk contamination, including 6 sellers of melamine and 12 milk suppliers accused of adding melamine to their products.  Police also seized 300 kg of chemicals, including 223 kg of melamine.  Additionally, 87 people were summoned for questioning and 28 were detained.

Over the next three weeks, the arrests continued.  By October 10, Hebei police had arrested 36 people in total, including a dairy farmer who was accused of producing over 600 tons of a protein powder made of melamine and maltodextrin, which he subsequently sold to food additive vendors, cattle farm owners, and fresh milk purchasers.

Another notorious recent example of swift Chinese “justice” was the execution of Zheng Xiaoyu, the former director of the Chinese State Food and Drug Administration.  According to government authorities, during Mr. Zheng’s tenure as State Food and Drug Administration director, from its founding in 1998 to his removal in mid-2005, he accepted bribes totaling $850,000.  In exchange, he allegedly approved drug production licenses for multiple untested and unsafe medicines, resulting in an unknown number of deaths.  In May 2007, after pleading guilty to charges of corruption and accepting bribes from pharmaceutical companies, Mr. Zheng was sentenced to death.  The court that sentenced Mr. Zheng stated that he had approved at least six fake drugs during his tenure.  Mr. Zheng was executed on July 10, 2007.

What makes these examples interesting is not only the harshness of the punishments compared to American law, but also the swiftness.  In Ms. Tian’s case, a mere day passed between her firing and her facing severe criminal charges.  In Mr. Zheng’s case, he was executed less than two months after sentencing.

Whether such harsh punishments will deter future wrongdoing in China is yet to be seen, and certainly the Chinese judiciary is not a place American courts or lawyers should turn for inspiration.  Nevertheless, PCA executives may want to take a moment to consider the fact that their reprehensible behavior is a capital offense in some parts of the world.  Likewise, executives of similar food companies that may be looking for ways to cut costs in this difficult economic climate may want to think twice about putting profits before ethics.  These executives owe it to their customers to ensure that the food they produce is safe.  They owe it to their customers to work to produce safe products as if their lives depend on it.

It seems that any serious discussion of E. coli O157:H7 always has to start with one event: the 1993 outbreak associated with the Jack in the Box restaurant chain.  This, of course, is with good reason.  That outbreak left over 700 persons ill and 4 children dead.  The “9/11 for the food industry,” as a certain trial lawyer has occasionally referred to the outbreak, precipitated a whirlwind of events including media coverage, consumer outrage, lawsuits, and stricter federal regulations regarding meat safety.  Though the swell of emotion that spiraled out of the Jack in the Box disaster dulls somewhat with each passing year, the federal regulations that sprung up in its wake continue to generate more questions.

To understand the significance of these regulations, a little background information is useful.  The Food Safety and Inspection Service’s (FSIS) stated mission renders it “responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.”  FSIS operates as part of the United States Department of Agriculture (USDA).  To promote its mission, FSIS has the power–under the Federal Meat Inspection Act (FMIA)–to, among other things, seek the recall of products that have been deemed “adulterated.”  FSIS drastically shifted how it interpreted and enforced the FMIA in 1994 when, following the Jack in the Box outbreak, the agency declared E. coli O157:H7 to be an adulterant.  This marked a dramatic change from its previous stance that pathogens in raw meat were not adulterants.

The declaration of E. coli O157:H7 as an adulterant was met with strong opposition from the meat industry.  In a lawsuit filed soon after the 1994 declaration, the industry accused the USDA of not following proper rulemaking procedures and of acting in an arbitrary and capricious manner beyond its legal authority.  The United States District Court held, however, that the USDA was allowed to interpret the FMIA and that the USDA has the power to declare substances to be adulterants with the intended purpose of spurring the meat industry to create and implement preventative measures. 

During the early part of this decade, however, it became readily apparent that O157:H7 was not the only deadly pathogen in E. coli family–in fact, far from it.  The Centers for Disease Control (CDC) recognized this fact when, in 2000, the agency made all Shiga toxin-producing E. coli (STEC) nationally notifiable.  The CDC subsequently referred to non-O157 STEC as emerging pathogens that pose a significant health threat, with more strains reported every year.  Still, FSIS remained steadfast in its stance that O157:H7 is the only enterohemorrhagic E. coli strain that should be deemed to be an adulterant.

So what’s wrong with FSIS’s position regarding E. coli O157:H7?  The simple answer is this: the people of this nation do not deserve another Jack in the Box-sized catastrophe as a pre-requisite for currently needed agency action.  The scientific and medical communities have recognized the dangers of all enterohemorrhagic E. coli, not just O157:H7, again and again.  Representatives of the CDC estimate that non-O157 STEC causes 36,700 illnesses, 1,100 hospitalizations, and 30 deaths annually.  Nearly two years ago today, on October 17, 2007, the CDC and FSIS even went so far as to hold a public meeting to consider the public health significance of non-O157 STEC.  In the Notice of the meeting, FSIS referred to the “growing awareness that STECs other than E. coli O157:H7 (non-O157:H7 STECs) cause sporadic and outbreak-associated illnesses.”  Nevertheless, following the meeting, FSIS failed to re-interpret its policies.

This brings us to today.  We’re nearing the end of 2009, closing in on seventeen years since the Jack in the Box outbreak.  Millions of Americans have suffered foodborne illnesses, injuries, and deaths in that time, thousands of them likely due to enterohemorrhagic E. coli other than O157:H7.  It is on behalf of those persons that the law firm of Marler Clark has authored a petition to FSIS requesting the agency to issue an interpretive rule declaring all enterohemorrhagic STEC, including non-O157:H7 serotypes, to be adulterants within the meaning of the Federal Meat Inspection Act.  

The petition details the scientific and legal bases for the requested action, but perhaps more importantly it details the suffering that food contaminated with non-O157:H7 enterohemorrhagic E. coli inflicted upon three individuals: June Dunning, Megan Richards, and Shiloh Johnson.  Ms. Dunning, whose infection was caused by E. coli O146:H21, unfortunately succumbed to her illness, passing in 2006.  Ms. Richards and Ms. Johnson endured lengthy hospitalizations, kidney failure, and will both endure a lifetime of medical complications as a result of their E. coli O121:H19 and E. coli O111 infections (respectively).  

It would be naïve to assume that a change to FSIS policy will immediately rid the world of all foodborne E. coli infections.  It has been unequivocally proven, however, that all enterohemorrhagic E. coli are potentially lethal pathogens that we must fight tooth and nail to keep out of this nation’s food supply.  If we trust science, and do our part to push government agencies to enact regulations to require better monitoring, we can no doubt begin to prevent further harm.  In the end, after all, the requisite wading through the mess of bureaucracy required to change federal regulation is all worth it, so long as the outcome prevents at least one more case like that of June Dunning, Megan Richards, or Shiloh Johnson.

To do this, I’m going to start with H.R. 2749, the Food Safety Enhancement Act of 2009.  One of the most pressing issues for small farmers is whether they will be subject to the new registration requirements of Section 101, and the fees and duties that accompany these requirements.  Section 101 explicitly states that “farms” are excluded from the registration requirements, but what exactly does this mean?  For this purpose, it’s handy to look at the specific language of the proposed law.  It states:

(D)(i) The term ‘farm’ means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.

(ii) Such term includes–

(I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;

(II) such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;

(III) such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;

(IV) such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; and

(V) a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.

(iii) Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.

Elsewhere (such as in the records keeping provisions), H.R. 2749 refers to the definition of “farm” from section 415 of the Food, Drug, and Cosmetic Act, which states:

The term `facility’ includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.  Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels…

Under the traceability provision, Section 107, the bill excludes food produced on farms, so long as it’s “sold by the owner, operator, or agent in charge of such farm directly to a consumer or to a restaurant or grocery store.”  The minimal requirement in such a scenario is that the farm must “keep records, in electronic or non-electronic format, for at least 6 months documenting the restaurant or grocery store to which the food was sold.”

The amended Section 112 only requires reporting to the Reportable Food Registry for farmers who distribute food in interstate commerce.

Gathering all of these provisions, we can form a complete picture of the type of “farm” that’s excluded from the H.R. 2749.  A farm that operates for personal use or primarily engages in face to face sales to consumers (at farmer’s markets for example) is excluded from the requirements.  On the other hand, a farm that sells mostly to resellers or (at least regarding the Reportable Food Registry) sells across state lines, must conform to the requirements of the bill.  The fact that any operation that “manufactures, processes, packs, or holds food” is a deemed “facility” sets a fairly low bar for operations that engage in a minimal amount of food processing.  Nevertheless, given the entire context of the bill, the farm cutout was created simply to protect local operations that sell raw produce directly to consumers.  

If you step outside of the realm of raw-product-to-consumer-sales, you end up with a “value-added” product for which operators must be held to a higher standard.  Though many concerned farmers (understandably) grumble at this distinction, the overriding point is that there are costs associated with expanding any business.  Farms that “manufacture, process, pack, or hold food” are, after all, very likely to be for-profit operations.  When a business owner decides that she wants to place a product into the stream of commerce, she must be prepared for the greater responsibility to consumers that accompanies the chance for higher profits.  The balancing act, as far as the legislation goes, consists of weighing the utility of the locally grown movement (remember the raw-product-to-consumer-sales exception) against the need to ensure the public that the food they buy is safe.

This is a trade-off that operators will have to take into account when considering whether to expand their operations beyond face to face sales.  Yes, it might mean that some fledgling operations may encounter roadblocks when expanding; however, an operation’s choice to engage in broader sales should not come at the expense of consumer safety and business accountability.  When a farmer decides that her product should be sold alongside corporate products, the farmer owes a duty to consumers to ensure that the product is held to the same national production, inspection, and safety standards that the corporate product must adhere to.  This isn’t a stand for big business; this is a stand for the health of the men and women who pay for these products.

In an ideal world, small farmers would be able to process goods, create value added packaged products, sell them to local resellers, and manage local supermarkets of safe food.  Unfortunately, as we’ve witnessed time and time again (Peanut Corporation of America comes to mind), business, ethics, and food safety do not always go hand in hand.  These bills, though woefully imperfect, are a result of that reality.