Ten years ago Thursday, our 2½-year-old son Kevin died from complications due to an E. coli O157:H7 infection. We later learned that Kevin’s strain of E. coli O157:H7 matched that of a meat recall issued 16 days after he died. Unfortunately, we were never able to conclusively prove that Kevin consumed the recalled meat, which was the requirement to show liability in the state where he died. As many of you know from Food, Inc., Kevin’s death and the challenges we encountered following his death propelled our family to advocate for Kevin’s Law and eventually establish a new non-profit, the Center for Foodborne Illness Research & Prevention.

Kevin’s Law was first introduced in Congress as the Meat and Poultry Pathogen Reduction and Enforcement Act of 2002 by Senators Tom Harkin, Dick Durbin and Hillary Clinton. It was later re-named Kevin’s Law in honor of Kevin and our family’s work to pass the legislation. Kevin’s Law was a response to a court of appeals ruling that USDA did not have the authority to shut down plants that repeatedly produced meat and poultry products that were contaminated with Salmonella (the Supreme Beef case of December 2001). Kevin’s Law required USDA to work with CDC to identify foodborne pathogens that impact human health, set limits for those pathogens in meat and poultry products, and then shut down plants that repeatedly fail to meet those limits. Despite being introduced in Congress three times, Kevin’s Law never passed. Key elements of Kevin’s Law were included in the recently enacted Food Safety Modernization Act, but that legislation applies only to FDA (with food safety oversight of dairy and produce), not USDA (with food safety oversight of meat and poultry).

Last week, Cargill announced a 36 million pound recall of ground turkey for an antibiotic resistant strain of Salmonella that has caused 107 illnesses and one death. Every day, new light is being shed upon the details of this recall and the associated outbreak investigation. According to published reports, USDA testing found this strain of Salmonella four times over the past year but did not take action. In fact, five months passed from the first reported illness to the recall. During that time period, many families — and particularly children — were unnecessarily put at risk of serious foodborne illness and even death. That is completely unacceptable. Government authorities should have acted sooner.

Unfortunately, the reality is that, due to the Supreme Beef ruling, USDA’s hands are tied. Unless a pathogen is considered an adulterant, USDA cannot take action — even if they find these pathogens during routine testing. Right now, E. coli O157:H7 is the only pathogen that is considered an adulterant. In January, USDA submitted a proposal to the White House Office of Management and Budget to declare six other E. coli strains as adulterants, but OMB has not responded. There is growing concern among public health officials in the United States about antibiotic resistant strains of Salmonella, but these are not considered adulterants either. Yet, in Europe, initiatives have already been introduced to reduce risks from antibiotic-resistant Salmonella.

Currently, USDA tests meat and poultry products for Salmonella and has limits in place for how much Salmonella can be in any particular testing sample of meat. The limits are woefully inadequate, and thanks to the Court of Appeals, they aren’t enforceable anyway. USDA can’t take action against a meat or poultry producer even if the limits are repeatedly exceeded.

For example, take ground turkey. When USDA tests for Salmonella, they take individual 1-pound samples on 52 consecutive days of production. Sometimes it takes a year to complete a set — and the establishment gets a heads up that a sample is going to be taken! In addition, if 26 or fewer are positive, the sample set passes. If more than 26 are positive, the sample set fails. Basically, these are like open book exams — not pop quizzes — where a 50% is still passing! And even when a sample set fails, USDA does another set of testing. And they keep doing testing until a set passes.

Under Kevin’s Law, USDA would have the authority to shut down a plant if it repeatedly exceeds acceptable limits. Right now, the testing continues until illnesses are actually linked to the product. As discussed in a previous blog, foodborne illness investigation is not easy and usually takes a lot of time, which is one of the reasons it took five months to issue this recall. Inter-agency communication problems also contributed to the delay in this situation.

The reality is that, if Kevin’s Law had been passed, this outbreak may have been avoided or, at the very least, USDA would have been able to take action sooner. USDA needs the authority to take action when contaminated products are causing human illness. They need to be able to set limits for foodborne pathogens. They need to reduce those limits over time to prevent fewer pathogens from entering the food supply. And, they need the authority to shut down producers that repeatedly fail to meet those standards.

We find it a bit ironic that this issue would arise again on the 10th anniversary of Kevin’s death. Our family has never given up on passing Kevin’s Law. It is clear that USDA needs these authorities before more American families suffer. I urge Congress to consider re-introducing Kevin’s Law, to pass Kevin’s Law, and we ask that you join us in making this a reality.

Kevin, we love you and miss you. You changed our lives forever, and we will continue to honor your life and your memory by working to make our food safer.

Kevin’s Mom and Dad,

Barbara and Michael Kowalcyk

Barbara Kowalcyk is the CEO of the Center for Foodborne Illness Research & Prevention. Michael Kowalcyk is an economist. He has advocated extensively for the passage of Kevin’s Law. This piece was first published August 11, 2011 in the Huffington Post. Reposted with permission.

“What’s that?” you may ask. Well, when it comes to food safety and foodborne illness, molecular epidemiology is critically important. It is the backbone of outbreak investigations and foodborne disease surveillance. Molecular epidemiology uses molecular techniques to study the impact of genetic and environmental risk factors on the causes, trends and prevention of disease. In less scientific terms, it means using DNA to find out what causes disease and what can prevent it. Basically, epidemiologists are disease detectives, and molecular epidemiologists use genetic information to do their detective work.

Over the past weeks, as we watched the E. coli outbreak in Europe unfold, there has been a lot of commentary on the efficiency and effectiveness of the European and German responses. I read criticisms of the amount of time it took to identify the outbreak, the premature announcement that cucumbers were the source, the lack of a definitive source, and so on. As I was reading, it was clear that many people do not understand the challenges that epidemiologists face in investigating foodborne illnesses. As an epidemiologist-in-training, I want to share with you a crash course in epidemiology. Welcome to Foodborne Illness Investigation 101.

Investigating foodborne illness is a really tough thing to do. It takes a lot of time, rarely follows a linear path and often is unsuccessful. It’s not surprising, since the deck is stacked against the investigator. When most people are sickened with foodborne illness, they immediately assume that the last thing they ate made them sick. If only it were that easy. Most likely it was something eaten several days before. For E. coli, it usually takes 3 to 10 days for symptoms to appear. For listeria monocytogenes, it can take up to 60 days — that’s right, two months.

Of course, most people don’t head to the doctor right away. Think about it. How sick would you have to be to go to the doctor and have a stool sample taken? Once the stool sample was taken, it would have to be sent to the lab and cultured which takes another couple of days — assuming the physician ordered the right test. Many foodborne illness tests are not automatically done — even though many physicians assume that they are. Once the culture is complete, the physician and/or laboratory are often required to report positive results to public health officials but, again, there are often delays.

(Maybe now you can see why the foodborne illness numbers are just estimates. Public health officials really only hear about the sickest people — the tip of the iceberg.) So, by the time you went to the doctor, had the lab test run, and public health officials were notified, the question is more likely what did you eat two to three weeks ago (and where). I’m sure you would be hard put to remember.

Enter the foodborne illness detective a.k.a. state or local health department epidemiologist. The bacteria have at least a two-week head start, and somehow the epidemiologist is expected to get ahead of it immediately. The investigation starts with an extensive interview with the patient about everything they ate, where they went, how many animals and sick people they had contact with, etc. The questionnaire is probably 10 pages long and takes a lot of time to complete. Meanwhile, a microbiologist will run additional tests so the genetic fingerprint of the bacteria can be uploaded into CDC’s PulseNET database to see if it matches other cases. Of course, entering the data into PulseNET is voluntary — completely voluntary. And since everyone is overloaded with work due to state budget cuts, it may take a while to get around to it even with the knowledge that timely entry into PulseNET is critical to identifying outbreaks. In fact, it’s how the 2006 spinach and 2009 peanut butter outbreaks were identified.

A couple of days later CDC announces a national outbreak related to the strain the epidemiologist uploaded. CDC hosts a conference call. All the people sickened have to be re-interviewed, because every state uses different questionnaires and the data can’t be combined to do the analysis that will help identify a source. (A while back, there was an effort to get all the states to use the same form, but only seven agreed to participate.) Re-interviewing patients will take time — especially if the state has a de-centralized surveillance system. Investigation activities must be coordinated across different divisions and branches of government so it is not uncommon for “turf” issues to arise.

Local health departments might be asked to re-interview the patients using the standardized form. They too are understaffed and overworked but may be reluctant to seek state or federal assistance with patient follow-up, citing confidentiality concerns. There might also be a sense that patients will be more receptive to additional inquiries from a local health department person with whom they have spoken with previously. These factors can contribute to delays in the investigation progress. Remember the 2009 Salmonella tomato/pepper outbreak that lingered on for nearly three months? One of the reasons it took so long to find a source was that local health departments refused to share information with their state health departments, and both refused to share information with CDC. It’s hard to do detective work if you don’t know where the victims are.

Now, if you are lucky, you are an epidemiologist in the state of Minnesota, where you’ll be able to take advantage of a centralized food safety system and Team Diarrhea (yes, it’s really called that). Team D — made up of graduate students from the University of Minnesota’s School of Public Health — swings into action at their command center and conducts standardized phone interviews. It’s super efficient and, once they get involved, Minnesota usually figures out the source. It is unbelievable that Team D is on the chopping block in Minnesota’s budget debate. Actually, every state needs a Team D.

Hopefully, by now, you are beginning to see why it can take so long to “solve” an outbreak and why so many end up being a “cold case” with only a list of potential suspects. As with regular detective work, centralized systems work in your favor and de-centralized ones increase the likelihood that you’ll end up with no clear-cut answer. The recent outbreak in Germany is a perfect example. An editorial in Nature published last week explains how Germany’s complicated, de-centralized surveillance system impacted that country’s ability to respond to the E. coli outbreak.

Sadly, the German system sounds a lot like the system we have in the United States. The Germans have two federal ministries, two federal technical institutes, and 16 state ministries involved in foodborne illness surveillance. In the United States, there are 15 federal agencies and thousands of state and local agencies involved. In both countries, the coordinating agencies — CDC and RKI — receive information indirectly and have n
o direct authority over the
sources of their information. At least the United States has PulseNET — for now. Already under-funded, PulseNET is in serious jeopardy as state governments furlough staff and/or choose not to replace staff who leave. Without timely data being uploaded into the database, PulseNET cannot identify outbreaks and prevent others from being sickened.

Early on, some lamented that if a definitive source was not found the German outbreak would be a lost opportunity to learn about the epidemiology of foodborne disease. I disagreed. One of the lessons learned is that sometimes centralization and standardization is a good thing — especially if you are a disease detective.

———————————

Barbara Kowalcyk is the CEO of the Center for Foodborne Illness Research and Prevention. She was voted the Huffington Post’s Ultimate Game Changer in the food category in 2010. This article was first published June 29, 2011 as “Welcome to Armchair Epidemiology: The How-To’s of Solving a Foodborne Illness Outbreak” on Huffpost Food on Huffington Post. Republished with permission.

—————————–

This outbreak is especially concerning given the high rate of hemolytic uremic syndrome (HUS) and the fact that so many victims are adult women. HUS in adults is uncommon — children are at highest risk of developing this serious complication of foodborne illness. It suggests that this is a particular nasty strain of STEC (shiga-toxin producing E. coli). HUS is a horrible disease that is characterized by cascading organ failure and can result, as in my son’s case, in death. Those who survive often suffer long-term health effects, including end-stage kidney failure, diabetes and neurological complications.

One of the most troubling aspects of the ongoing outbreak in Europe is that it involves a strain of E. coli that often flies under the radar in the United States. In recent years, public health officials and food safety advocates — myself included — have been increasingly concerned about this class of E. coli, which is often referred to as non-O157 STECs.

In fact, numbers released this week by the Centers for Disease Control show that the United States has about the same number of non-O157 STECs as O157:H7 STEC. This means that it is time to change the way we handle these deadly pathogens. In 1994, Mike Taylor declared E. coli O157:H7 to be an adulterant in meat and poultry products when he was Undersecretary of Food Safety at USDA. In recent years, USDA has repeatedly been asked to address this and declare the “Big Six” non-O157 STECs to be adulterants as well, but so far no action has been taken.

Worse, the Office of Management and Budget (OMB) recently ruled that non-O157 STECs in beef products are not economically significant and delayed action on a proposal to declare them adulterants. I’m certain that Germany and Spain would disagree. Given the significant cost associated with STEC infection and its severe long-term health outcomes, these pathogens are clearly economically significant.

In Europe, the cost of this outbreak will likely run into the millions — if not billions — when you consider the impact on those sickened, the amount of public health resources used to track the illnesses and find the source, and the lost market share for the cucumber, lettuce, tomato and sprout industries. As this outbreak demonstrates once again, foodborne disease is economically significant — especially in these hard economic times.

Every time I hear about one of these outbreaks, my heart breaks again for the families affected. I understand their pain and desperately wish that my efforts to improve food safety could have prevented these tragedies. While disheartened, I am all the more determined to prevent this from happening to others. I do not want those sickened to have suffered in vain. I hope their experiences will force the food industry and governments around the world to re-evaluate their food safety systems and move from the current reactive systems to a proactive one. Achieving that will take significant investments in food safety. With the current global economy, it may seem like we can’t afford to do that right now, but the reality is that we can’t afford not to.

Unfortunately, at a time when people around the globe are focusing on food safety, last week a key Congressional subcommittee proposed significant cuts to the FDA and USDA food safety budgets. If passed through Congress, these budget cuts will make it nearly impossible for FDA to implement the new, higher standards in the recently signed food safety bill or for USDA to take action on non-O157 STECs. The United States will be taking a giant step backwards.

It’s always interesting to watch food safety events — and U.S. politics in general — unfold from Europe. Last fall, while I began my research project at the National Institute of Public Health and the Environment in the Netherlands, my family watched the passage of the Food Safety Modernization Act of 2010 and endured puzzled questions and disbelief that such solid legislation promoted such strife in the U.S. This time around there are more questions — largely driven by reports that the United States feels that Europe is mishandling the outbreak investigation. I find this ironic since the U.S. doesn’t really look for non-O157 STECs and we have had some highly publicized outbreaks that took months — not weeks — to solve.

Epidemiologic investigations are time-consuming and often lead public health officials down many different paths. Of course, the decentralized nature of Germany’s public health system — not unlike many U.S. states — has not helped the situation. But, regardless of the errors that may have been made, I still think Europe — especially Denmark and the Netherlands — is ahead of the curve when it comes to food safety. The United States can learn from their experiences and should follow their lead. We can start by adequately funding food safety and declaring the “Big Six” non-O157 STECs adulterants.

—————–

Barbara Kowalcyk is the CEO of the Center for Foodborne Illness Research and Prevention. She was voted an Ultimate Game Changer in 2010. This post was first published June 8, 2011 on Huffington Post.

I was recently asked what I would do if I had a food safety magic wand.

For me, that’s a loaded question, and it honestly took my breath away. I often dream of having such a magic wand so that I can do the one thing I’ve never done but desperately want to do–sit down for a family meal with my husband and all four of our children.

I would use that wand to go back to that fateful day in 2001 when the process broke down and the food that my 2 ½ year old son Kevin eventually ate became contaminated with E. coli O157:H7.  With the flick of my wand, I would change the course of my family’s life.

Every terrible memory of watching Kevin suffer, holding him after he died and the crushing grief that followed would be wiped away. My oldest, Megan, would have her best friend back– along with her childhood–and my younger two would finally meet the older brother they have grieved but never met. And then I would repeat this for every family I’ve met who has suffered a serious foodborne illness and all the ones I haven’t.

Sadly, I’d be a very busy person.

Now, there is a problem with my plan, and it is a big one. The problem is that it is reactive–it only deals with the problem after it has occurred. Kind of reminds me of our current food safety system–reacting to food safety crises instead of strategically planning to prevent them. So, as much as I’d like to go around wiping away the terrible memories of foodborne illness and the long term health outcomes that so often follow them, I would also want to use that wand to build a proactive food safety system that focuses on public health and prevents foodborne disease from happening in the first place.

So far, I don’t think I’ve said anything that anyone disagrees with. Getting people to agree on the need for a more proactive food safety system isn’t the hard part–it’s the how that stirs up all the controversy. The important thing is that we have an open, frank and reasonable discussion that involves all stakeholders. If we can do that–and I recognize that I might need to pull out my wand just to achieve that–then I think there’s hope for achieving our vision of a proactive food safety system.

A couple of years ago–hard to believe it was that long–I was invited to serve on a National Academies of Science Institute of Medicine committee to review the FDA’s role in ensuring safe food.  Last June, after 18 months of deliberations and writing, the committee of 13 published our report, “Enhancing Food Safety: the Role of the Food and Drug Administration,” that provides guidance on how to build a proactive, risk-based food safety system, not just within FDA. but overall.  In the report, the committee made the following recommendations for improving food safety:

• Adopt a risk-based approach to food safety that provides “a systematic means by which to facilitate decision making to reduce public health risks in light of limited resources and additional factors that may be considered.”

• Conduct comprehensive strategic planning for the development and implementation of a risk-based food safety system using a transparent process that involves stakeholder participation.

• Design and implement an integrated information infrastructure that provides the foundation necessary for bringing together the vast amounts of surveillance, behavioral, economic, and food production data needed to support a risk-based food safety system.

• Create a research infrastructure that balances basic and applied research to support and refine risk-based decision making.

• Integrate and harmonize federal, state and local government food safety programs in order to leverage efforts, eliminate duplication, improve responsiveness and increase inspection frequency.

• Increase the efficiency of inspections by adopting a risk-based approach to inspection frequency and intensity, with minimum standards, and improving training and inspection techniques.

• Develop a risk communication strategic plan that integrates communication into an overarching risk-based management strategy; improves our understanding of the knowledge, perceptions and behaviors of various stakeholder groups, and provides one voice for communicating timely, clear and accurate information to stakeholders.

• Modernize food safety legislation to provide FDA with the authorities it needs to fulfill its mission: mandatory registration of food facilities; authority to suspend registration for public health violations;  mandatory preventive controls; authority to issue enforceable performance standards; mandatory adoption of a risk-based approach to inspection frequency and intensity ; authority to mandate recalls; expansion of access to records, and authority to ban imports from countries that have inadequate food safety systems.

• Elevate and unify the efforts of all agencies and departments with major responsibility for the safety of the food supply through the establishment of a single food safety agency.

• Enhance the government’s ability to ensure a safe food supply by establishing an independent, centralized risk analysis and data management center that could also serve as a stepping stone to a single food agency.

I would use my wand to implement all these recommendations.

I would replace our fragmented, reactive system with a coordinated, proactive one; expand and improve our surveillance systems; remove institutional resistance to change and cultural barriers to data sharing; increase research funding; establish and enforce standards for federal, state and local food safety inspections; increase responsiveness to crises, and modernize food safety laws for all regulatory bodies, not just FDA.

 Of course, none of this is possible without adequate financial and human resources. Sadly, in this current anti-spending climate, the Food Safety Modernization Act–which incorporated some of the NAS recommendations–is at risk of becoming an unfunded mandate. So, I would use my magic wand to have Congress see the wisdom in investing in preventing foodborne disease instead of just responding to it.

Of course, I know that government can only do so much when it comes to food safety so I would also use my magic wand to have all food producers recognize the importance of adopting a food safety culture–from the top down–that puts the health and well-being of their customers first and recognizes their role in protecting public health.

I would use my magic wand to have company executives see their moral obligation to produce safe food and the wisdom in accepting responsibility when things do go wrong, rather than blaming the victim.

I would also use my wand to end practices that hinder food safety, such as putting a premium on the lowest price rather than on safety and quality; d
enying paid sick leave to food handlers; downplaying the inherent risks in their food products, and engaging in agricultural practices that ignore human and environmental impacts. With a flick of my wand, all food producers would embrace this new food safety culture and would adopt preventive controls aimed at stopping contamination at its source.

 I would not stop there because I know that, no matter how good the system is and how hard people try, there will occasionally be failures and people will get sick. So, I would use my wand on health care professionals to improve diagnosis, treatment and reporting of foodborne illness. And I would use my wand to improve the public health infrastructure to respond to crises that occur by providing adequate resources at the federal, state and local levels and by building the human capacity necessary to support it.

I would also use my magic wand on schools to implement targeted education strategies around food safety and on private funders to provide the resources needed to support organizations that are trying to drive all these changes.

Finally, I would use my magic wand–if it wasn’t worn out–to change how we think about the food we eat. Food is something we all consume and one of our most valuable resources.  Despite the abundance of food choices in this country, we often don’t think about the food that we are putting into our bodies and the impact it has on our health and our environment.

We don’t think strategically about food as a culture or as individuals. But we should and, in this country, we are blessed to have the power to change that. So, I would use my magic wand to get everyone to understand that food and food safety is a global health issue; to recognize the importance of adopting a comprehensive One Health approach that integrates human, animal and environmental health; and to vote for food safety both politically and with your buying power.

And maybe–just maybe–if I do all that, I’ll actually succeed in giving my friend Bill Marler what he wants–to go out of business because people are no longer suffering from foodborne disease. In the meantime, I’ll keep dreaming…   

Mr. Boyle’s first misuse of statistics was to inappropriately use USDA’s E. coli O157:H7 testing data.  USDA’s E. coli O157:H7 microbiological testing program is strictly regulatory and was not statistically designed to estimate the prevalence of E. coli O157:H7 in raw ground beef.  Different establishments are sampled each year.  Further, the methods used to select establishments and to conduct the microbial testing have changed over the years.  Several sources, including USDA itself, have noted the limitations of the data obtained from USDA’s Verification Testing Programs.[2,3,4,5,6,7]

With this in mind, let’s really look at Mr. Boyle’s statistic on the incidence of E. coli O157:H7 in raw ground beef.  In 2000, USDA conducted microbial tests that showed a certain level of contamination at specific USDA-inspected meat and poultry plants.  In 2008, USDA conducted microbial tests at a different group of USDA-inspected meat and poultry plants across the country.  Indeed, if you compare the numbers from these two years, there appears to be a 45% reduction.  But remember, the data is coming from two different groups of plants!  This would be the equivalent of saying that, because Joe weighed 300 lbs in 2000 and Bill weighed 150 lbs in 2008, Americans have experienced a 50% weight loss.  No researcher would draw such a conclusion!  Clearly, it is inappropriate to use USDA’s E. coli testing data to make year-to-year comparisons, as Mr. Boyle has done.

Mr. Boyle further compounded this error with a second misuse of statistics when he selectively compared 2000 and 2008 data and ignored recent trends that may not reflect positively on the industry’s performance.  Let’s use Mr. Boyle’s approach and assume that it is appropriate to use USDA’s E. coli O157:H7 data to make year-to-year comparisons (again, it is not!).  A comparison of USDA’s 2008 data to recent years (2003 – 2007) would show an increase in E. coli O157:H7 in raw ground beef.[8]

Similarly, Mr. Boyle selectively compared CDC’s FoodNet 2008 and 2000 data, concluding that E. coli O157:H7 infections have decreased by 44%.  Again, this statement is misleading and ignores recent trends.  In actuality, CDC does not compare individual years of FoodNet data (i.e. 2008 vs. 2000).  Rather, CDC compares the data for a given year to a composite of the 1996-1998 FoodNet data and to a composite of the preceding three years, which in this case would be 2005-2007 FoodNet data.  This is done to account for changes in the number of FoodNet sites and changes in the size of the population.  It is true that, when comparing the 2008 FoodNet data to the 1996-1998 composite, E. coli O157:H7 infections have decreased 25%. [9,10]  However, when comparing the 2008 FoodNet data to the 2005-2007 composite, E. coli O157:H7 infections have not changed significantly.

Mr. Boyle’s recent assertions represent an inappropriate use of data and did not provide the American public with a complete and clear picture of recent trends in E. coli O157:H7.  In fairness, Mr. Boyle is not alone in making this error.  In fact, USDA’s own Website states that that data from these testing programs provide information about the trends in pathogen presence in meat and poultry products over several years.  But as stated above, the data should not be used for these purposes.  Even so, using Mr. Boyle’s and USDA’s logic, it could be said that, despite initial declines, the incidence of E. coli O157:H7 in raw ground beef has not changed in recent years and may even be increasing.  However, due to significant data limitations, even this statement would be misleading.  The reality is that, based on the data collected, no one can reliably conclude that the incidence of E. coli O157:H7 in raw ground beef has gone up, gone down, or stayed the same.

Mr. Boyle has asserted that the “meat industry has made great strides in improving the safety of our products.”  It is true that AMI and USDA have spent huge amounts of money to improve food safety over the past 15 years.  For this, they should be applauded.  Unfortunately, it is also true that, despite these efforts, E. coli O157:H7 remains a problem in raw ground beef.  Misusing statistics to paint a “rosy picture” of the meat and poultry industry is not helpful.  Instead, we need to openly face this problem and work together to find solutions.

APPENDIX

Progress Report on Salmonella Testing of Raw Meat and Poultry Products, 1998-2002, USDA Food Safety Inspection Service

The prevalence data reported here for Salmonella in raw meat and poultry products have certain limitations that restrict the range of valid statistical inferences.  The PR/HACCP verification testing program is strictly regulatory in nature and was designed to track establishment performance rather than to estimate nationwide prevalence of Salmonella in products.  Because the program is not statistically designed, different establishments may be sampled from year to year, confounding rigorous trend analyses.  Furthermore, it is important to note that the prevalence estimates computed from the FSIS’s pre-HACCP baseline studies and surveys were nationally representative because they were weighted on the basis of the production volume of the sampled establishments.  In contrast, the PR/HACCP Salmonella prevalences from the regulatory testing program reported here represent unweighted test results from sampled establishments.

Food Safety and Inspection Service Oversight of Production Process and Recall at ConAgra Plant (Establishment 969), USDA Office of Inspector General Great Plains Region Audit Report, Report No. 24601-2-KC, September 2003

FSIS’ E. coli O157:H7 testing program cannot be used to measure the effectiveness of HACCP on either a company or a nationwide basis.  The sampling program, as designed, does not provide scientific, risk-based data to measure the extent of an existing hazard.  The data that isproduced does not reflect industry performance because

a)    plants like ConAgra, that performed their own E. coli O157:H7testing on  carcasses were exempt from sampling of ground beef,

b)    sampling plans do not take into account all relevant plant operational or processing factors, and

c)    samples taken at the plants that are selected are not always representative of the lot of production or final product.”

Microbiological Testing Programs for Ready-to-Eat (RTE) Meat and Poultry Products, USDA Food Safety Inspection Service

The data presented here are from regulatory testing programs that change from year to year and even within years and thus any comparisons should be made with caution.  The findings are referred to as prevalence data in that they are presented in terms of the percentage of regulatory samples that are found to be positive.  These programs have not been designed to test for statistically significant change from one year to the next.  The aggregate data do, however, provide an overall indication of trends….. None of the RTE sampling programs, either before or after December 2000, were designed to provide statistical estimates of national product prevalence.  These programs do, however, provide an indicator of whether pathogen prevalence is increasing or decreasing across different product categories.

Progress Report on Salmonella Testing of Raw Meat and Poultry Products, 1998-2008
www.fsis.usda.gov/Science/Progress_Report_Salmonella_Testing/index.asp

Restructuring how Salmonella sets are scheduled means that comparison of results from 2006 onwards to previous years will be less meaningful in terms of trends. Similarly, the changes to the verification program will prevent valid comparisons of testing results over time (e.g., quarter-to-quarter or year-to-year trends).

Microbiological Results of Raw Ground Beef Products Analyzed for

Escherichia coli O157:H7, Summarized by Calendar Year www.fsis.usda.gov/Science/Ecoli_O157_Summary_Tables/index.asp

Beginning with CY 2008, annual microbiological sample results will be posted according to the date the sample was collected. Prior to CY 2008, yearly posting of microbiological data results was based upon the sample analysis completion date. For this reason, data from CY 2008 can not be directly compared to CY 2007 and prior years. In addition to the change in date criterion, target sampling that incorporates production volume and results history was introduced as well as incorporating a change in the laboratory testing method.

The FSIS Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products, 1990-2008

www.fsis.usda.gov/Science/Micro_Testing_RTE/index.asp#trends

Throughout the history of the FSIS microbiological RTE regulatory sampling program, the individual projects have been continuously evolving in response to public health concerns. The data reported here are from these individual sampling projects that have been implemented under the overall RTE program. This testing program has not been designed to test for statistically significant changes from one year to the next. The aggregate data do, however, provide an overall indication of trends…. As mentioned above, the FSIS does not view the results of regulatory testing as estimates of national product prevalence.

References:

1. NY Times (http://www.nytimes.com/2009/10/07/opinion/l07meat.html?_r=1), Larry King Live (10/12/09)
2. FoodSafety and Inspection Service Oversight of Production Process andRecall at ConAgra Plant (Establishment 969), USDA Office of Inspector

   General Great Plains Region Audit Report, Report No. 24601-2-KC,

   September 2003

3. Microbiological Results of Raw Ground Beef Products Analyzed for Escherichia coli O157:H7, Summarized by Calendar Year  www.fsis.usda.gov/Science/Ecoli_O157_Summary_Tables/index.asp
4. Progress Report on Salmonella Testing of Raw Meat and Poultry Products, 1998-2002, USDA Food Safety Inspection Service
5. Microbiological Testing Programs for Ready-to-Eat (RTE) Meat and Poultry Products, USDA Food Safety Inspection Service
6. ProgressReport on Salmonella Testing of Raw Meat and Poultry Products, 1998-2008 www.fsis.usda.gov/Science/Progress_Report_Salmonella_Testing/index.asp
7. The FSIS Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products, 1990-2008 www.fsis.usda.gov/Science/Micro_Testing_RTE/index.asp#trends
8. http://www.fsis.usda.gov/PDF/RGB_Testing_Figure1.pdf
9. http://www.cdc.gov/foodnet/factsandfigures/trends.html
10. The confidence interval for this estimate is (8%, 39%).