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Will USDA's Food Safety Agency Ever Have a Leader?
by Matthew Madia | Jun 07, 2010
Food Safety News reported that there is no timetable for moving the nomination of Elisabeth Hagen to the Senate floor. Hagen, currently the chief medical officer at the U.S. Department of Agriculture (USDA), is the nominee to lead the Food Safety and Inspection Service (FSIS), the USDA agency responsible for ensuring the safety of meat and poultry products.
President Obama did not nominate Hagen until Jan. 26, 2010, more than a full year into his term. Then, the Agriculture Committee waited until May 27, another four months, to hold a nomination hearing. Now, the committee will need to hold another hearing to report the nomination to the full Senate.
During the nomination hearing, Sen. Blanche Lincoln (D-AR), chair of the committee, complained that FSIS had not yet proposed a rule requiring inspection of catfish and defining exactly what species will be treated as catfish. "I believe that this is one of the more pressing food safety concerns that exists right now," she said. The 2008 Farm Bill requires FSIS to write and enforce catfish regulations. The bill set a final deadline of December 2009, but FSIS has yet to even propose the rule, let alone finalize it.
Lincoln is, quite frankly, full of it. If the catfish inspection rule, or food safety in general, was a priority for Lincoln, she would have moved Hagen's nomination much more aggressively.
The catfish inspection rule is currently under review at the White House Office of Information and Regulatory Affairs (OIRA). FSIS prepared a draft proposal and submitted it to OIRA on Nov. 13, 2009. OIRA is supposed to spend no more than 120 days reviewing agency drafts, but the rule has now been under review for 201 days and counting.
Inside U.S. Trade (sorry, subscription only) reported earlier this year that the proposal has stalled amid concerns lodged by the Office of the U.S. Trade Representative, another arm of the White House. USTR is concerned about the rule's impact on trade and potential costs to importers. Choosing which species will be classified as catfish could also affect trade, because several different types of imported fish species are marketed as catfish in U.S. stores. Needless to say, Congress delegated decisions on the definition and other aspects of the rule to USDA, not USTR or OIRA.
Aside from the trouble surrounding the catfish rule, FSIS has made little progress on its rulemaking agenda, publishing only one proposed rule and no final rules in the last six months. It is safe to assume that FSIS's ability to write new rules has been severely hampered by its lack of a Senate-confirmed leader.
Why then, would Lincoln stall the confirmation of the one person who could jump start rulemaking at FSIS? A Senate-confirmed leader would be more effective at setting priorities for the agency and more likely to stand up to OIRA and/or USTR if they are indeed holding up the catfish inspection rule.
The Agriculture Committee has only held three hearings in all of 2010, according to its Website, so don't expect Lincoln to move quickly on the nomination.
Will USDA's Food Safety Agency Ever Have a Leader? by Matthew Madia originally appeared on OMB Watch Matthew June 3, 2010. Republished with permission from OMB Watch and the author.

FDA should adopt risk-based approach to food safety
By EurekAlert Tuesday, June 8, 2010
WASHINGTON -- The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks, says a new report by the Institute of Medicine and National Research Council.
To more proactively tackle food safety problems, FDA should implement a risk-based approach in which data and expertise are marshaled to pinpoint where along the production, distribution, and handling chains there is the greatest potential for contamination and other problems, the report says. The agency would then be able to direct appropriate amounts of its resources and attention to those high-risk areas and increase the chances of catching problems before they turn into widespread outbreaks, said the committee that wrote the report.
The report offers FDA a blueprint for developing a risk-based model. It also outlines several organizational steps the agency should take to improve the efficiency of its many food safety activities, such as increasing coordination with state and other federal agencies that share responsibility for protecting the nation's food supply. In addition, the report says Congress should consider amending the Federal Food, Drug, and Cosmetic Act to explicitly provide the authority FDA needs to fulfill its food safety mission.
"As recent illnesses traced to produce underscore, foodborne diseases cause significant suffering, so it's imperative that our food safety system functions effectively at all levels," said committee chair Robert Wallace, professor, College of Public Health, University of Iowa, Iowa City. "FDA uses some risk assessment and management tactics, but the agency's approach is too often reactive and lacks a systematic focus on prevention. Our report's recommendations aim to help FDA achieve a comprehensive vision for proactively protecting against threats to the nation's food supply."
FDA is responsible for ensuring the safety of approximately 80 percent of the nation's food supply, including seafood, dairy products, and fruits and vegetables. Although it is not the sole organization overseeing food safety -- the U.S. Department of Agriculture handles meat, poultry, and egg products, and state and local agencies share in conducting food production facility inspections, surveillance, and investigations of outbreaks -- recent outbreaks of foodborne illness led to a congressional request for a review of gaps in FDA's food safety system.
The agency has been criticized for not adequately monitoring and inspecting food suppliers and distributors and for not taking a proactive approach to food safety overall. However, given that FDA is responsible for more than 150,000 food facilities, more than 1 million restaurants and other retail food establishments, and more than 2 million farms, as well as millions of tons of imports, it lacks the resources to sufficiently monitor the entire food supply, the committee noted.
A risk-based approach would give FDA's food safety officials the strategic vision needed to evaluate and plan for food safety concerns rather than tackling problems on a case-by-case basis, the report says. Without good information, agency officials cannot identify where its resources are needed most or determine which policy interventions are most effective. FDA has insufficient analytical expertise and infrastructure to gather, manage, and use data effectively. The agency should identify its data needs and review its policies for sharing data with other agencies and organizations.
The federal government should establish a centralized food safety data center outside of the regulatory agencies to collect information and conduct rapid, sophisticated assessments of food safety risks and appropriate policy interventions. This center would go a long way toward developing much-needed capacity and would reduce interagency competition for resources, the committee said. It could also serve as an intermediate step toward consolidating food safety activities within a single agency, which many individuals and organizations have called for.
To enhance its efficiency, FDA should explore alternative approaches to regulating food safety, such as delegating food facility inspections to the states, the report says. FDA should establish national standards for the intensity and frequency of these facility reviews and help states and local municipalities bring their safety programs up to those standards. Once all programs are standardized, FDA should train and certify state inspectors with the goal of turning over the majority of inspections to them under the agency's supervision. This change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors under contract with FDA. This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort, the committee said.
Despite the dramatic developments in food production and distribution that have occurred over the years, the main statutory provisions under which FDA carries out its food safety responsibilities remain largely unchanged. Although various provisions give the agency broad discretion and flexibility through which it has been able to control potential problems, there are instances in which FDA lacks specific authority, which can make its actions vulnerable to court challenge. Congress should examine how the legislation could be revised to detail FDA's authorities in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration, and banning of food imports if the public's health is at risk, among other areas.

Congressional watchdog: Monitoring the government's food safety regulators
Friday, June 4, 2010; 3:42 PM
Lisa Shames is the ultimate consumer watchdog, a federal employee working every day to ensure that government agencies do their job protecting the safety of our nation's food supply.
As director of food safety and agricultural issues at the Government Accountability Office (GAO), Shames has pushed and prodded the Food and Drug Administration (FDA), the Department of Agriculture and other federal agencies to strengthen their regulatory oversight, and has blown the whistle when they have fallen short.
After countless inquires for the congressional watchdog agency, Shames and her team were responsible for placing federal food safety activities on the GAO's high risk list in 2007, raising a number of red flags about a highly "fragmented" system that functions poorly and leaves Americans vulnerable to foodborne outbreaks and serious health problems.
"We must make sure that our work is fact-based and data-driven," Shames said. "In the end, we draw conclusions and recommend actions that are intended to correct the deficiencies we found."
Shames' team found many problems ¢¯ sporadic FDA inspections in countries exporting food to the United States, inadequate monitoring of food containing ingredients from genetically engineered crops, insufficient attention to the unintentional introduction of pharmaceutical and industrial compounds into the food supply, and lack of oversight to insure that companies comply with food-labeling laws and regulations.
According to Shames, these and other problems with the food safety system are "becoming more and more urgent" as the population becomes more susceptible to foodborne illness due to aging and other factors.
Her work in food safety is critical ¢¯ about 76 million cases of foodborne diseases occur in the U.S. each year, leading to more than 300,000 hospitalizations and 5,000 deaths.
As part of her inquiries, Shames and her team have analyzed relevant laws, regulations and guidance; assessed information on program implementation, such as inspection records; spoken to agency officials and other stakeholders; and visited ports to see how agency officials inspect foods that cross the borders.
Recently Shames visited Miami; Laredo, Texas; Buffalo, NY; and Baltimore to observe food from other countries arriving by plane, truck and ship.
"We don't like to do armchair auditing. We feel that site visits add to the credibility of the work that we're doing," she said. "We often learn things that we wouldn't have learned by reading documents."
Chris Mihm, GAO's managing director for strategic issues, said Shames has been "part of and instrumental to a cultural change that we've seen in government ¢¯ the understanding that citizen expectations aren't based on activities, they're based on demonstrable results."
Throughout more than 30 years at GAO, Shames has been exposed to a variety of topics, from defense to energy policy, that have helped inform her most recent work on food safety.
"A core set of competencies ¢¯ critical thinking, communication, collaboration ¢¯ enable us to be parachuted into any issue to give a bottom-line assessment and to identify recommendations to try to correct any deficiencies," she said. "It's the sort of job where you can never get bored."
Pat Dalton, GAO's managing director for natural resources and environment, cited Shames' critical thinking skills as key to her success.
"Lisa can see the big picture. In all of her work, she is thinking about whom we're working for ¢¯ the public ¢¯ and how we can deliver solid results for the money that the public has invested," Dalton said.
According to Shames, the ability to review public programs and improve government performance attracted her to the GAO.
"I like that we try to make a difference," Shames said. "I believe that government has a very positive role. At GAO, we can ensure that the government role is being done as efficiently and effectively as possible."
This article was jointly prepared by the Partnership for Public Service, a group seeking to enhance the performance of the federal government, and Visit for more about the organization's work.

The Raw Milk Fights: Economics, Ideology, or Both?
by Marion Nestle | Jun 08, 2010
Yesterday's New York Times has an op-ed, "Crying over raw milk", about the political fights over raw milk in Wisconsin. The Wisconsin legislature has introduced a bill allowing dairy farmers to sell raw milk directly to consumers. The conventional dairy industry is not happy about that.
The author of the piece, Michael Feldman, is dubious about the purported health benefits of raw milk but is quite clear about its economic benefits: "you can't get $6 a gallon for pasteurized milk."
Crass economics is behind much of the politics of raw milk these days. The conventional dairy industry is in trouble: too many cows, too much milk, and not nearly enough regulation of supply. In contrast, raw milk has passionate advocates willing to pay premium prices.
Not fair, says the dairy industry, which wants raw milk to be regulated:
"In a letter to two senior members the Senate Committee on Health, Education, Labor and Pensions, the dairy groups called for a measure obliging all facilities producing raw or unpasteurized milk products for direct human consumption to 'register with FDA and adhere to the tried-and-true food safety requirements that are followed by all other facilities producing milk products."
As for the safety of raw milk, it is useful to take a look at Seattle attorney Bill Marler's website: "Real Raw Milk Facts." There, he summarizes recent cases of illness caused by toxic E. coli and Salmonella contaminants in raw milk. These constitute a full employment act for attorneys like Marler who represent victims of foodborne illness.
My position on raw milk has long been that people have a right to drink it but it had better be produced safely. I believe that all foods-no exceptions-should be produced under well designed and carefully followed HACCP plans (or their equivalent) with pathogen testing at intervals commensurate with the level of risk.
But food safety experts tell me that raw milk can never be tested frequently enough to be confident it is safe.
Raw milk carries a greater risk of bacterial contamination than pasteurized milk and people who buy it should know what those risks are. The risk may be small, but it is finite. Putting a child at risk of hemolytic uremic syndrome from toxic E. coli just doesn't make sense to me.
Like Michael Feldman, I'm dubious about the claims made for the health benefits of raw milk. No question, it tastes better and that may be reason enough to want it. But until I can be sure that the producer is scrupulous about safety, my personal choice favors pasteurization.
But that's just me. You?
Editor's Note: The raw milk fights: economics, ideology, or both? by Marion Nestle first appeared at Food Politics on June 7, 2010. Republished with permission from the author.

Report: FDA must be proactive to keep our food safe ? Give States more power over food safety

June 9, 11:08 AMDallas Healthy Trends ExaminerKK Thornton
The Institute of Medicine released its long anticipated study on US food safety yesterday, and the results were not pretty for the FDA. The IOM food safety report concluded that the FDA is not doing enough to protect the American public from food borne illnesses, in part because the FDA's management style is reactive instead of proactive-- a fact which the people of Dallas are unfortunately all too aware. And the IOM's recommendations could have Dallas residents blaming the State of Texas instead of the FDA for the next big salmonella or E. coli outbreak.
Congress asked the federally funded IOM, part of the National Academy of Sciences (NAS) to study food safety in the US and prepare a report with its findings and recommendations 18 months ago. The NAS report recommends that the FDA change its management style to be more proactive, with more strategic planning, targeted surveillance and risk analysis, instead of the FDA's current strategy of reacting to outbreaks of food borne illnesses on a case by case basis.
Incredibly, as the recent cases involving tainted salad dressings, peanuts and the recall of Children's Tylenol and other children's medications illustrate, the FDA still does not have the power to issue recalls on its own. As a result, the toothless FDA is effectively forced into letting the food industry regulate itself which has led to devastating effects, as illustrated by the increasingly frequent and widespread outbreaks of food borne illnesses due to pathogens such as e coli, salmonella, listeria and campylobacter. Every year in the US, there are 76 million cases of foodborne illness causing more than 300,000 Americans to be hospitalized and 5,000 US deaths.
The FDA is responsible for overseeing food safety in all US dairy, seafood, fruits and vegetables produced in the United States, restaurants, supermarkets and other food service providers, as well as processed foods and imported food items. And while the USDA is responsible for meat, poultry and eggs and various other federal and state agencies are already performing a great deal of food safety inspections, it's clear that the FDA has a lot on its plate, and that the FDA needs more funding and more authority before it is able to deal effectively with US food safety.The sheer numbers involved in the FDA's food safety purview are astounding. According to the NAS report, the FDA responsible for the safety of about 80% of the nation's food supply, more than 150,000 food manufacturing and processing facilities, over one million restaurants and other food service establishments, and more than two million farms.
In the NAS report, the IOM also recommends that the FDA turn over all responsibility for facility inspections to state agencies, but many consumer groups, including the Center for Science in the Public Interest, do not agree that its proposal is such a good idea. "Tasking these overburdened, understaffed and underfunded state agencies with additional responsibilities will produce only frustration and not safer food." said Sarah Klein, CSPI staff attorney.

Committee report urges more centralized food safety system
Posted on June 8, 2010 by Drew Falkenstein
Food safety experts and the public have criticized the FDA¡¯s food safety system and questioned whether it properly safeguards Americans from foodborne
diseases. Thus, Congress asked the Institute of Medicine (IOM) to examine the gaps in the current food safety system under the purview of the FDA and to identify the tools needed to improve food safety. Although the FDA recently created the Office of Foods to oversee and coordinate all food policy efforts within the agency, the FDA¡¯s approach to food safety continues to be reactive, lacking a systematic focus on prevention. The IOM committee¡¯s report, Enhancing Food Safety: The Role of the Food and Drug Administration, suggests that the FDA lacks a comprehensive vision for food safety and says it should change its approach in order to properly protect the nation¡¯s food.
Loosely translated, the Institute of Medicine's consensus report finds that the FDA simply cannot protect this country's food supply in the modern world, and that the approach needs to change before things get worse . . . or just stay the same. Some of the IOM's specific findings and suggestions:
1. The agency should use a risk-based approach to evaluate food safety problems rather than its current reactive approach to food safety.
2. The FDA should define the roles of all responsible parties, including suppliers, farmers, retailers, consumers, and government agencies among others. The FDA also should develop a comprehensive, transparent strategy for choosing the level and intensity of policy interventions, which can range from setting standards to educating the public.
3. The FDA has limited analytical expertise and lacks the infrastructure to collect, analyze, interpret, manage, and share data, thus precluding the FDA from using data to support decision making. It is critical that the FDA evaluate its food safety data needs including surveillance, behavioral, economic, food production, and other data based on a risk approach. The FDA reports that sharing data among government agencies is difficult; therefore, the committee recommends that the FDA review the data sharing statutes and policies and develop plans to improve the sharing of data in a timelier manner by all federal, state, and local food safety agencies.
4. Food safety activities, such as inspections, surveillance, and outbreak investigations, are divided between the states and the federal government. The states are responsible for foods produced or sold within their borders and the federal government shares jurisdiction with the state and local governments for food transferred across state borders. However,these systems are not well integrated; a more integrated system would minimize duplication of food safety activities by leveraging the efforts of the state and local governments. In an effort to normalize and integrate food safety practices across the nation, the FDA should provide
standards to states and localities and oversee their implementation.
5. The FDA¡¯s Office of Foods needs direct authority over the inspectors who work in the field, to minimize substantial delays in policy implementation that affect how inspections are conducted. Also, to increase efficiency, the FDA should streamline inspections to ensure that the amount of time and rigor used to inspect a facility is based on risks to the public¡¯s health and should set minimum standards for the frequency and intensity of the inspections of all facilities. Since a number of food safety inspections already are conducted at the state and local levels, the committee recommends that, once their food safety programs and activities meet federal standards, the FDA conduct fewer inspections and instead delegate them to the states and localities. A small group of inspectors should remain within the FDA to audit inspections, provide specialty expertise, develop training material for inspectors, and conduct inspections in situations of special need.
6. In order for the FDA to better ensure food safety, legislative and organizational
changes are necessary. Most notably, Congress should consider taking legislative action to provide the FDA with the authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management.

Wisconsin co-op votes to prohibit members from selling raw milk

By Julian Martin

June 9, 2010
After nearly a year of debate, the nation¡¯s largest organic farm cooperative voted recently to prohibit its members from selling raw milk. More than 1,600 dairies nationwide belong to Wisconsin-based Organic Valley Cooperative, 150-200 of which are estimated to supplement their business with unpasteurized milk sales.
The announcement follows Wisconsin Gov. Jim Doyle¡¯s decision last month to veto a bill legalizing raw milk sales. Sales of raw milk are illegal in the state, with the exception of small, unadvertised sales directly to consumers.
Raw milk does not undergo pasteurization, which heats milk to a specific temperature in order to kill harmful bacteria. Without pasteurization, milk can potentially carry disease-causing organisms such as E. coli, Salmonella and Campylobacter. In the last month, foodborne illness outbreaks linked to raw milk have been reported in Minnesota, Washington and Utah.
Supporters, however, claim the beverage provides a tastier and more nutritious alternative to pasteurized milk.
¡°We¡¯ve had many instances just in the last few months where people have had sicknesses from the raw milk business and it¡¯s caused us angst and trouble,¡± said Organic Valley CEO George Siemon to North Country Public Radio. ¡°The raw milk has brought a whole new work load of supporting other people¡¯s business and the membership just felt like that wasn¡¯t our role.¡±
The co-op has not been implicated in any foodborne illness outbreaks linked to raw milk, but its decision was based on the potential publicity damage an outbreak could have on the brand, according to BevNET.

Video study shows foodservice workers cross-contaminate once an hour
By Rita Jane Gabbett on 6/10/2010
Foodservice workers, on average, commit one act of cross-contamination with the potential of leading to illness per hour, according to a North Carolina State University study based on video cameras placed in commercial kitchens.
"We found a lot more risky practices in some areas than we expected," lead author Ben Chapman, assistant professor and food safety specialist, said in a statement, noting that meals prepared outside the home have been implicated in up to 70 percent of food poisoning outbreaks.
For the study, researchers placed small video cameras in unobtrusive spots around eight foodservice kitchens that volunteered to participate in the study. There were as many as eight cameras in each kitchen, which recorded directly to computer files and were later reviewed by Chapman and others. What they found demonstrates the need for new food safety-focused messages and methods targeting food handlers.
The study results statement used as cross-contamination examples: using a knife to cut raw chicken and then using the same knife to slice a sandwich in half or raw meat dripping onto vegetables that are to be used in a salad.
"And it's important to note that the foodservice providers we surveyed in this study reflected the best practices in the industry for training their staff," said Chapman.
The study also confirmed the long-held supposition that more food-safety mistakes are made when things are busier in the kitchen. "During peak hours, we found increases in cross-contamination and decreases in workers complying with hand-washing guidelines," Chapman said.
Suggested solutions
The researchers outlined solutions they said could be applied to the foodservice industry, including:

Food-safety training for kitchen staff that addresses the "team-like" nature of a commercial kitchen, rather than focusing on food handlers as individuals
Installing hand sanitizer units in accessible areas of the kitchen and
Overhauling existing food-preparation schedules so that cooks face less time pressure during peak hours.
The study, "Assessment of Food Safety Practices of Food Service Food Handlers: Testing a Communication Intervention," was co-authored along with Chapman by Douglas Powell and Katie Filion of Kansas State University, as well as Tiffany Eversley and Tanya MacLaurin of the University of Guelph in Canada.
It was published in the June issue of the Journal of Food Protection.

Rare Salmonella subtype sickens 34 in Illinois
Lisa Schnirring Staff Writer
Jun 4, 2010 (CIDRAP News) ? State and county health officials in Illinois are investigating an outbreak involving a rare Salmonella subtype that has sickened 34 people who reportedly developed symptoms after eating at Subway restaurants.
The Illinois Department of Public Health (IDPH) said in a statement yesterday that the outbreak involves a rare serotype, Salmonella enterica Hvittingfoss. The IDPH said it usually sees only one or two Salmonella Hvittingfoss infections each year. The Subway restaurants the sick patients reported eating at are located in 14 central Illinois counties.
Reports of illnesses began on May 14, and the latest onset date was May 25. Patient ages range from 6 to 88 years. Fourteen people were hospitalized, and all are recovering, according to the IDPH.
Though the outbreak strain has not been confirmed in a Subway product, the company is cooperating with health officials and has withdrawn lettuce, green peppers, red onion, and tomatoes from the dates illnesses were reported and replaced them with new produce, the IDPH said.
In other foodborne illness developments, the number of patients sickened in a Salmonella Newport outbreak linked to alfalfa sprouts has grown by 7 to 35, with the number of affected states rising to 11 with the addition of Pennsylvania, the US Centers for Disease Control and Prevention (CDC) reported yesterday.
Of 30 patients for whom the CDC has information, 7 (23%) were hospitalized. No deaths have been reported.
The CDC said an investigation is continuing at the sprout processor, Caldwell Fresh Foods, based in Maywood, Calif. The company recalled the sprouts on May 21, some of which were sold at two major national retail outlets, Walmart and Trader Joe's.
Meanwhile, in a Minnesota investigation of Escherichia coli O157:H7 infections in four people who drank raw milk from a dairy in Gibbon, Minn., state laboratory officials confirmed the outbreak strain in multiple animals and at multiple sites at the farm, according to a statement from the Minnesota Department of Agriculture (MDA).
Lab testing also found another form of Shiga toxin?producing E coli in a cheese sample collected at the farm, which the MDA says demonstrates an ongoing contamination pathway at the site.
Minnesota health officials have also confirmed a fifth case linked to the outbreak, a young child who was not hospitalized. The Minnesota Department of Health (MDH) is investigating several other illnesses linked to products from the farm, and the MDA has embargoed the facility's dairy products.
MDH Commissioner Dr Sanne Magnan said in the MDA statement that drinking raw milk poses a serious health risk. "This risk isn¡¯t a matter of personal opinion; it's an established scientific fact. Drinking raw milk or eating products made from raw milk can expose consumers to a variety of organisms that can result in anything from a few days of diarrhea to kidney failure and death," she said.
"Raw milk is especially dangerous for children, whose immune systems can't fight off infection as well as healthy adults."

Minnesota Department of Health Responds to Hartmann Dairy on the Raw Milk E. coli O157:H7 Outbreak
Yesterday after giving a speech to NEHA on the dangers of the industrialized beef supply, I received the following email statement from the Hartmann Dairy which is at the center of an E. coli O157:H7 outbreak in Minnesota that has sickened at least five. Here is the relevant part of the email:
Not a single test of raw milk was found to contain any strain of e.coli.
At paragraph 9, the State wrote in the Petition that of the 103 samples tested, 9 samples tested positive for e.coli, a bacteria found in the lower intestines of virtually all mammals. Of the 9 samples, none was from any milk cow; 4 calves manure (not milked), manure from a cow pen (beef cows, not dairy, not milked), manure from a pasture for dry cows (not milked), manure from a steer yard (steers are not milked), manure from 2 heifers (not milked), and manure from one sheep (not milked). No claim is made that any sample from a dairy cow or the dairy barn contained any e.coli.
Two samples of cheese, one cheddar and one herb and spice Gouda, made from raw milk were found to contain a strain of e.coli that the state could not identify as e.coli 0157:H7. A third positive test for an unidentified strain of e.coli was taken from a bucket of clean-up rinse water. As everyone knows, cheese is intentionally cultured with bacteria to create the product and until a specific strain is identified there is no evidence of contamination.
As of today, there is no evidence of any harmful bacteria in any raw milk, cheese, meat or other product sampled from the Hartmann farm. The State has engaged in a serious regulatory and potentially criminal action in a grossly negligent manner with total disregard for the defamatory content of their media campaign.
Minnesota Department of Health responded. The response, in part, is below:
What evidence do you have that raw milk from the Hartmann farm caused the illnesses?
This investigation began like many other foodborne investigations: Someone becomes ill, sees their physician and the physician sends a stool specimen to a clinical laboratory. If that laboratory finds, or ¡°isolates¡±, one of a number of illness-causing bacteria (eg., Salmonella, E. coli O157:H7), they send that bacterial isolate to the MDH Public Health Laboratory (PHL) for further testing. Each bacterial isolate is DNA fingerprinted by a technique called pulsed-field gel electrophoresis (PFGE). (See image of electrophoretic gels in this outbreak: )
During May 2010, E. coli O157:H7 isolates from 5 patients sent by separate clinical laboratories to the MDH PHL were found to all have the same DNA fingerprint by PFGE testing.
This particular DNA fingerprint type (which also can be called a ¡°strain¡±) of E. coli O157:H7 had never been seen before in Minnesota. The fact that multiple patients all were infected with this new strain in such a tight timeframe indicates that there was a common source for the illnesses. In other words, the patients must have acquired their infection from the same source.
In any foodborne illness investigation, MDH epidemiologists interview patients about an extensive array of possible exposures. These interviewers use a standard questionnaire and interview technique. This includes asking questions about what the ill people ate, including meat, produce and other food items. It also includes questions about recreational water and drinking water, contact with animals, daycare attendance, and more.
In this outbreak, the ill people came from communities across Minnesota, and the only exposure the cases had in common was consumption of raw dairy products from the Hartmann farm. This connection, and the fact that the same strain of E. coli O157:H7 found in the ill people was found in several animals and from several environmental samples on the Hartmann farm, clearly indicates that the farm was the source of the E. coli O157:H7 that made the people ill.
What is the significance of finding E. coli O157 in the environmental samples from the farm?
The strain found on the farm matches the strain found in the cases of illness. Again, this is a strain that has never been seen before in Minnesota.
This tells us that the bacteria that sickened the people was on the Hartmann farm and since several of the people that became ill never visited the farm, their only potential source would have been food products from the farm.
Did you find the outbreak strain in dairy product from the cases¡¯ homes or from the farm?
The outbreak strain of E. coli O157:H7 has not been found in product yet. However, product samples that were collected from the farm were obtained one week to several weeks after production of products that made people sick. Other strains of Shiga toxin-producing E. coli were found, indicating an ongoing problem with contamination.
The fact that the outbreak strain was not found in samples of product taken from the farm or homes does not mean it wasn¡¯t in the product that sickened the individuals. In many cases, only particular batches of product may have been contaminated. The product from the contaminated batches may not be available for testing because it has already been consumed. Even if the contaminated batches are available for testing, the contamination may not be uniformly distributed throughout the product. It can be difficult to find the ¡°needle in the haystack¡± when only small amounts of product are able to be used for a laboratory test. The fact that some pathogen was not found in a sample taken today does not mean it wasn¡¯t there yesterday or a week ago, or won¡¯t be there tomorrow. Also, since raw milk contains many types of bacteria it is a difficult process to isolate individual bacteria growths and find the disease-causing strains.
The outbreak strain of E. coli O157:H7 was found in the manure of some individual calves, sheep, and cattle pens. Of note, the calves were likely drinking the same milk as that consumed by the cases.
Standard public health practice does not require finding the illness strain of pathogen in either environmental or product samples in order to determine the source of an outbreak and before intervention to prevent further illness should be initiated. In fact, it is quite rare in foodborne investigations that food product is available for testing as it is often perishable or has been completely consumed by the time the outbreak is recognized. State health and agriculture officials often act on epidemiologic evidence to remove contaminated products from the marketplace and prevent additional illnesses. Indeed, to do nothing in the face of such compelling evidence would be irresponsible ? regardless of the size or nature of operation implicated.
Are there more cases being investigated?
Yes, MDH has received additional reports of illness in several consumers of Hartmann dairy products that it is investigating.
The Minnesota Department of Health Epidemiologists and the Health Department lab are considered the best in the country at investigating foodborne outbreaks. Its response to the Hartmann Dairy is as devastating to Hartmann's wishes as it is accurate and clear.
Posted on June 9, 2010 by E. coli Attorney

Illinois Subway Salmonella outbreak case count up to 68
Posted on June 9, 2010 by Drew Falkenstein
The Salmonella outbreak at Subway restaurants around the state of Illinois has claimed 68 confirmed victims--a number that will probably continue to grow as more and more illnesses are identified as part of the Subway Salmonella outbreak.
The Illinois Department of Public Health's updated announcement states as follows:
Salmonella Update
(as of 12 p.m., June 9, 2010)
Confirmed cases of Salmonella serotype Hvittingfoss ? 68.
Age range of confirmed cases: 2 to 88.
Cases have reported eating at 30 Subway restaurants located in 24 counties - Bureau, Cass, Champaign, Christian, Coles, DeWitt, Fulton, Knox, LaSalle, Lee, Livingston, Macon, Marshall, Moultrie, Ogle, Peoria, Sangamon, Schuyler, Shelby, Tazewell, Vermilion, Warren, Winnebago and Will.
The investigation is ongoing. Numbers will be updated Thursday, June 10.

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