Written in Collaboration with Alison Gocke
It sounds like a story right out of science fiction: A microscopic killer that shuts down the food supply, cripples a nation's exports, and leaves scores of people dead and thousands more ill. Such an event would seem unthinkable in the modern world of advanced agriculture and medical practice. But it did unfortunately occur several months ago as a result of an outbreak in Germany caused by a deadly, rare strain of E. coli bacteria that sickened more than 4,000 people and killed more than 50.
The strain, whose genome was just recently sequenced by scientists at the University of Maryland, is particularly virulent, carrying a combination of both Shiga toxin (which causes severe gastrointestinal illness like bloody vomiting, diarrhea, and sometimes, kidney failure) and a unique ability to adhere to the intestinal wall. The bacteria -- part of the serotype 0104:H4 -- is thus one of the most rare, deadly E. coli lines in existence. 
Over the past five years, from the E. coli scare found in California spinach to the recent outbreak of salmonella in ground turkey, serious and sometimes fatal illnesses resulting from contaminated food have occurred more frequently than expected. Since 2006, the U.S. Centers for Disease Control and Prevention (CDC) has issued 39 warnings of multi-state foodborne illness occurrences. 
It is estimated that 48 million people are infected by foodborne diseases in the United States each year , resulting in $152 billion in medical costs annually.  And these outbreaks show no sign of abating; the incidence of salmonella infections alone has increased 20 percent since 1997.  With 170 countries exporting food to the U.S., and more than 70,000 food safety violations on food that is imported into America reported from 1998 to 2004 alone, the E. coli outbreak in Germany -- with additional cases reported in France and the U.S. -- shines a spotlight on why the issue of food safety is an international concern. 
According to the World Bank, more than two-thirds of countries globally are net importers (i.e., imports exceed exports) of food.  The devastating European E. coli outbreak that began in Germany in May illustrates the interconnectedness of the global food supply. From the beginning, the E. coli incident created an international chain reaction: Confusion early on in the investigation of the source of the outbreak led to erroneous warnings about Spanish cucumbers, tomatoe, and leafy greens as the source of infection.  As a result, Russia suspended food imports from all member countries of the European Union. 
However, upon further investigation, public health officials from the European Centre for Disease Prevention and Control (ECDC) now believe the source of infection to be sprouted seeds (a category of germinated seeds that includes fenugreek, lentil and bean sprouts) imported from Egypt and purchased by a German company.  The infected seeds were then sold to Britain, which in turn sold them in France, where reports of infections from the same strain of E. coli as that found in Germany surfaced a month ago.  The outbreak even reached the United States, with six confirmed cases of Americans infected by the German strain.  According to the European Food Safety Authority, the Egyptian seeds -- more than 11 tons in total -- were shipped around the world, purchased by 54 companies in Germany and disseminated among at least a dozen other European countries.  Investigators are now working to locate the remaining shipments of Egyptian seeds to prevent further disease outbreaks.
This incident highlights the fact that agriculture in the 21st century involves industrial-sized farms and corporations harvesting their products from all corners of the earth, and selling them across the globe, crossing national borders. This makes the issue of food safety much more complex. The good news is that many serious foodborne illness outbreaks are preventable; an efficient and effective food safety agency that monitors farms and factories, maintains an effective epidemiological and emergency response team, and provides up-to-date, accurate information to the public in the face of an outbreak can go a long way in reducing the spread of disease and its related costs. Unfortunately, this type of agency is the exception rather than the rule, including in America.
Until recently, the food safety mission of the U.S. Food and Drug Administration (FDA) was focused on response rather than prevention. The FDA had little authority to inspect food production at all levels of the supply chain, issue guidelines for proper cultivation of produce (thus reducing outbreaks at their source) or verify that food imports came from reliable growers. The agency could only suggest that infected foods be recalled -- it had no powers to require companies to remove their products, even if they were found to carry diseases.  And for three years now the FDA has been requesting additional funds to increase inspections of foreign foods, claiming that the agency does not have the resources to meet the demand. 
Furthermore, the creation of a seamless system of food safety programs is impeded by the split functions between the FDA and the U.S. Department of Agriculture (USDA). The U.S. Department of Agriculture, which is responsible for the inspection of meat, eggs and poultry under the Food Safety Inspection Service (FSIS), has had its own issues with implementation of food safety procedures. Approval of regulations for the inspection of six strains of E. coli found in beef -- known as the "Big Six" -- have stalled in the White House Office of Management and Budget, leaving some experts wondering whether the U.S. meat industry is vulnerable to E. coli outbreaks. Consequently, a number of ground beef businesses have begun testing for E. coli at their plants. This is possible because tests created and used by the USDA have recently become commercially available. Scientists are now working to develop a new kit that would test for the German E. coli strain as well. 
The FDA does not have procedures in place to test regularly for the Big Six strains of E. coli either, which can also be found in produce.  The problem is exacerbated by the fact that the USDA and the FDA often overlap in their duties. For instance, although the USDA's mission is confined to inspecting meat, poultry and some eggs, with the FDA regulating all other foods and drugs in the U.S., a simple frozen pepperoni pizza would fall under the jurisdiction of both agencies. As a result, almost 1,500 food establishments are inspected by both the USDA and the FDA. The overlap creates inefficiencies in the system and could delay responses in the case of a serious foodborne illness outbreak. 
Fortunately, steps forward in fixing life-threatening problems in food safety prevention and response in America were taken this year with the passage of the Food Safety Modernization Act (FSMA) in January of 2011. The legislation, the first serious reform for U.S. food safety since 1938, brings the FDA's food safety authorities into the 21st century , with new powers for the agency to require prevention-based checks across the food supply; standardize inspections for food producers; mandate food recalls in the case of an outbreak; and improve coordination among the FDA and other government agencies, including the U.S. Department of Agriculture (USDA) and the CDC. 
The FSMA also addresses the international component of food safety: Under the FSMA, the FDA is given the authority to require importers to verify the quality standards of their suppliers, to refuse admission to imported food if the foreign facility refuses to allow an FDA inspection and to require certification that imported food is in compliance with food safety requirements. The legislation also mandates more frequent inspections of foreign food suppliers, with inspection quotas increasing each year after the FSMA is implemented. 
Additionally, the FSMA aims to harmonize some of the shared responsibilities between the FDA and the USDA. The legislation calls for increased coordination between the two agencies under the categories of food vulnerability assessments, private sector coordinating councils for agriculture and food defense, laboratory networks and data sharing, and decontamination and disposal standards. Although the legislation does not change the jurisdiction of either agency, it requires that the USDA and FDA, along with other agencies of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Homeland Security (DHS), collaborate on a National Agriculture and Food Defense Strategy.  The FSMA is a much-needed step forward in protecting Americans from foodborne illnesses and, hopefully, reducing the costs of outbreaks in terms of productivity loss and economic impact.
But now the FSMA faces a whole new hurdle: the movement in Washington to tighten the reins on federal spending. This year, the U.S. House of Representatives voted to cut the 2012 FDA budget by $87 million dollars -- that's $87 million less than the FDA received last year, and $226 million short of what's needed to enact FSMA.  The House also proposed cuts to the Food Safety Inspection Service of the USDA, which is responsible for the inspection of meat, poultry and eggs.  The proposed cuts mean that the FDA will struggle to keep up with its inspections as well as maintain a coordinated and speedy response system in the case of an outbreak. It also reduces the likelihood that the FDA will have the resources to establish the new FSMA system to inspect imported foods. That means that foreign suppliers may not have to meet the same food safety standards as do domestic farmers. 
The FDA is not the only agency involved with food safety to face budget reductions this year. The House of Representatives has also proposed cuts to the Food Safety Inspection Service of the USDA, which is responsible for the inspection of meat, poultry and eggs.  In addition, all funds were cut for the national foodborne pathogen monitoring program overseen by the USDA, known as the Microbiological Data Program. This program is considered by many public health officials as one of the first lines of defense against foodborne illnesses in the United States, because it screens fruits and vegetables for common pathogens like salmonella and E. coli.  The Microbiological Data Program has regularly screened around 15,000 produce samples a year for the past ten years, as compared to the 1,000 samples spot-checked annually by the FDA. In the past two years alone, the program's screenings have led to 19 product recalls. 
The looming budget cuts have prompted a warning from the FDA. Recently, the agency released a special report entitled Pathway to Global Product Safety and Quality. The document underscores that the current food safety infrastructure is simply unable to support the inspections required to keep contaminated foods from entering the U.S. market. This is in part due to the fact that imports of food and drugs to the United States have increased six-fold over the last ten years. Almost 80 percent of medication ingredients,75 percent of seafood, and 60 percent of fruits and vegetables consumed in the United States come from other countries. And though FSMA takes these statistics into account -- requiring the FDA to inspect at least 600 foreign food suppliers over the course of a year -- the report says implementing the task will be impossible without additional funding. 
The FDA report also emphasizes that food-borne illnesses result in 325,000 hospitalizations and 5,000 deaths annually in the United States alone.  A recent nationwide outbreak of Salmonella sickness (resulting in the recall of 36 million pounds of ground turkey produced in an Arkansas meat plant) underscores the seriousness of food poisoning as a public health threat in America.
Greater attention to reducing food-related infections would save lives and contribute to reducing health care costs as well. The report underscores that today's world of agricultural practices in a global food supply chain require a modern system of food safety inspection. The Food Safety Modernization Act (FSMA) is a long-awaited step towards improving our country's food safety system. The recent E. coli outbreak in Europe, the high incidence of food-borne illnesses in the United States as illustrated by the latest Salmonella outbreak and the FDA's report highlight why adequate resources are urgently needed to fully implement the FSMA, and why food safety must be made a national priority in the United States and around the world.
For more information, visit foodsafety.gov.
Rear Admiral Susan Blumenthal, M.D. (ret.) is the Public Health Editor of the Huffington Post. She serves as Director of the Health and Medicine Program at the Center for the Study of the Presidency and Congress in Washington, D.C., a Clinical Professor at Georgetown and Tufts University Schools of Medicine, and Chair of the Global Health Program at the Meridian International Center. She served for more than 20 years in health leadership positions in the Federal government in the Administrations of four U.S. Presidents, including as Assistant Surgeon General of the United States, the first Deputy Assistant Secretary of Women's Health, as a White House Advisor on Health, and as Chief of the Behavioral Medicine and Basic Prevention Research Branch at the National Institutes of Health. Dr. Blumenthal has received numerous awards including honorary doctorates and has been decorated with the highest medals of the U.S. Public Health Service for her pioneering leadership and significant contributions to advancing health in the United States and worldwide and was the recipient of the 2009 Health Leader of the Year Award from the Commissioned Officers Association. Admiral Blumenthal has been named by the National Library of Medicine, The New York Times and the Medical Herald as one of the most influential women in medicine and as a Rock Star of Science by GQ by the Geoffrey Beene Foundation.
Alison Gocke, an undergraduate at Princeton University, serves as a Health Policy Intern at the Center for the Study of the Presidency and Congress in Washington D.C.
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