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New York now linked to E. coli O145 Outbreak in Michigan and Ohio - as many as 47 now sickened in three States

Misti Crane of the Columbus Dispatch (she has covered her fair share of E. coli outbreaks) reported a few moments ago that Health officials in New York have linked a person's illness there to the E. coli outbreak in Columbus, Ohio and Ann Arbor, Michigan, and are looking into at least 12 more possible cases.
As she reported earlier, all five confirmed Columbus cases have now been genetically linked to the outbreak in Michigan where seven cases have been confirmed with 14 probable. Eight other probable cases in Ohio are under evaluation. The Ohio Department of Agriculture is testing four food samples as is Michigan. Students at Ohio State University and the University of Michigan are among those sickened in the outbreak.
Never hear of E. coli O145 before? - click HERE to see why. We have found E. coli O145 in hamburger - "PREVALENCE OF NON-O157 ENTEROHAEMMORRHAGIC ESCHERICHIA COLI IN RETAIL GROUND BEEF IN THE UNITED STATES," but it is still to early to say if this outbreak is hamburger or some leafy green - like lettuce.

E. coli outbreak in Ohio and Michigan: what's the common link?
Posted on April 26, 2010 by Drew Falkenstein
A week ago, we reported on a developing E. coli outbreak in Washtenaw County, Michigan. Notably, the outbreak is not attributable to E. coli O157:H7--the most notorious of all E. coli strains--but it does appear to be a shiga-toxin producing strain of E. coli. Apparently, the outbreak is no longer confined to Washtenaw County, or even the state of Michigan, as Ohio has now reported illnesses in Columbus-area residents, including several students of Ohio State University.
Certain press accounts have indicated that a single Washtenaw county restaurant is the source of the Washtenaw county portion of this outbreak, but the Ohio and OSU illnesses apparently match the Michigan illnesses, which means that we're probably dealing with an outbreak linked to a regionally distributed food product. Could it be lettuce, as we saw in the September 2008 E. coli O157:H7 outbreak linked to Aunt Mid's and Santa Barbara Farms lettuce? Ground beef? Answers will likely, hopefully, come soon, as investigating health authorities compare the food histories of all infected people.
The Columbus Post Dispatch reported as follows regarding the five Ohio and OSU E. coli illnesses:
Columbus Public Health has identified five cases of E. coli infection, some of them in Ohio State University students, and is looking into five others that might be connected to an outbreak in Washtenaw County, Michigan.
The five Columbus residents were sickened by the bacteria Escherichia coli starting in mid-April, said Dr. Mysheika LeMaile-Williams, the city's medical director.
Some were hospitalized, but none so far have developed hemolytic uremic syndrome, a potential complication that destroys red blood cells and can cause kidney failure and death.
The E. coli tests that have come back from the state indicate that its not E. coli 0157:H7, which is most commonly implicated in outbreaks, LeMaile-Williams said.
All types sicken people in the same way, she said. The primary symptoms are bloody diarrhea and abdominal cramps.
So far, the state lab has determined that two of the cases have genetic fingerprints that match an outbreak in Michigan, LeMaile-Williams said.
In Michigan, several cases have been linked to a restaurant, said Ohio Department of Health spokeswoman Jen House. She did not know the name of the restaurant. Calls to Michigan health officials were not immediately returned. Washtenaw County is home to Ann Arbor.
So far, there's no known source for the infections, nor any known risk for others in Columbus, LeMaile-Williams said.
OSU spokeswoman Liz Cook said the university is working closely with Columbus Public Health but would not provide any details about the students.

Non-E. coli O157:H7 Outbreaks linked to Colorado Prison (E. coli O111) and Ohio and Michigan Mexican Restaurants (E. coli O145)
Eleven inmates at Four Mile Correctional Center may be ill with E coli O111 infections. Colorado Department of Corrections spokeswoman Katherine Sanguinetti says three cases have been confirmed, with eight more suspected cases. Officials were working with the state health department to prevent the spread of the bacteria among inmates at the minimum-security prison.
Apparently, an E. coli O145 outbreak is no longer confined to Washtenaw County, Michigan or even the state of Michigan. Ohio now reports E. coli O154 illnesses in Columbus-area residents, including several students of Ohio State University. Press accounts have indicated that a single Washtenaw county, as yet unnamed Mexican restaurant, is the source of the Washtenaw county portion of this outbreak. The Ohio and OSU illnesses match the Michigan illnesses.

Produce Industry Talks Safety, Traceability
by Helena Bottemiller | Apr 23, 2010
Produce safety and traceability were two central topics of discussion this week at the United Fresh Produce Association's 2010 industry conference in Las Vegas.
The increased industry-wide focus on improving food safety and ensuring products are traceable from farm to fork comes as Congress considers legislation to overhaul outdated food safety in an effort to prevent deadly and economically damaging foodborne illness outbreaks.
"Food safety is the new, big hot button demand," said Walter Ram, vice president of food safety for The Giumarra Companies, an international produce business. "It's the one we have to pay the most attention to."
The United Fresh exhibit hall featured two demo centers, one focused on food safety and one on traceability. Each hosted a series of presentations and discussions on issues ranging from micro testing to import safety to the produce safety rulemaking process.
In a speech at the conference, Michael Taylor, deputy commissioner for foods at the U.S. Food and Drug Administration (FDA), who is leading food safety efforts at the agency, emphasized the need for national produce safety standards and invited industry input.
"We need to be risk-based and we need to be scale-appropriate," said Taylor. "We've got to target the significant hazards. We can't just go and set standards that we don't believe will address the significant hazards and are improving food safety. We need input from this association and colleagues throughout the industry to help us figure out in practice to say that we'll have rules that are scale-appropriate."
James Gorny, senior advisor for produce food safety at the Center for Food Safety and Nutrition at FDA, echoed a similar message during sessions at the food safety demo center. Gorny discussed the importance of industry involvement as the agency looks at new rules on preventative controls, metrics, and performance standards.
"We're calling for preventative controls," said Gorny, in a session focused on FDA's proposed food safety rule. "We understand we can't do business as usual. We have to make sure everyone comes up to basic compliance and we need clear standards to get there."
"We recognize that rules will need to be tailored," added Gorny. "We understand the produce industry is not one entity. There are 300 different commodities, and there are different scales."
The traceability demo center sessions, which were very well-attended, focused on the Produce Traceability Initiative (PTI), a project launched by United Fresh and the Produce Marketing Association (PMA) in 2008 to standardize produce industry traceability practices.

New Meat Rules Could Mean Fewer Processors, Higher Prices
Submitted by Editor on Fri, 04/23/2010 - 12:12pm.
Chris Torres
Staff Writer
The comment period on a proposed clarification of standards affecting meat processors has been extended to June 19.
The USDA¡¯s Food Safety and Inspection Service (FSIS) is considering a set of revisions to the Hazard Analysis Critical Control Points (HACCP) program, of which the public comment period was originally supposed to expire on Tuesday.
But pressure from industry trade groups has led the government to extend the comment period an additional two months.
The proposed revisions, which Jay Wenther, executive director of the American Association of Meat Processors, described as ¡°widely vague and widely interpretable,¡± could hit smaller meat processors hard because it would require them to spend more money on additional testing on things that have been done for years under the existing HACCP system.
¡°This is going to be a severe financial burden,¡± Wenther said.
Custom butchers would likely be exempt.
The association has estimated that it will cost as much as $12,000 for the initial testing and perhaps as much as $3,600 for each year after, depending on the product line being tested.
In its ¡°Draft Guidance: HACCP Systems Validation,¡± FSIS sites the need to clarify the ¡°validation¡± portion of HACCP.
HACCP, which is mandatory for the meat, poultry, seafood and juice industries, is a process used to identify areas in which foodborne illness can be prevented using scientifically proven sanitary practices. It was introduced in 1996.
In the draft guidance, FSIS states the need to clarify validation procedures is necessary because of ¡°widespread lack of understanding of validation that FSIS had found .700among establishments¡± and ¡°because of food safety problems that have occurred as a result.¡±
Depending on the product being produced, each one has its own HACCP standard to account for differences.
For example, a processor would have different HACCP plans for slaughtering beef or chicken.
Under the draft guidance, as many as 13 samples of raw meat from each product line would have to be checked for levels of bacteria and other potential sources of foodborne illness.
Along with that, additional samples, as many as 13 more, would have to be sent out for testing after the product is processed into its ready-to-sell form. That would mean a total of 26 tests.
This is where small processors, which often produce a variety of products, could be greatly impacted, according to Wenther.
He questioned the reasoning for the revisions and the government¡¯s claim that it is based on food safety issues.
¡°Consistently, the only answers we¡¯ve been given is the agency believes they have information through food safety assessments or potential recalls that the entire industry needs to stop and do this,¡± he said. ¡°They¡¯ve been very, very vague about that.¡±
Wenther¡¯s organization, along with eight other industry groups, has sent letters urging FSIS to reconsider the changes.
Iowa¡¯s Secretary of Agriculture Bill Northey sent a letter recently to USDA Secretary Tom Vilsack expressing concern over the changes.
The Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America (R-CALF USA) also sent a letter to Vilsack, challenging the revisions.
|Local processors are worried about how the changes could impact their businesses.
Michael Smucker of Smucker¡¯s Meats in Mount Joy, Pa., said the changes would likely force the business to drop product lines and raise prices.
The average processing bill, which for beef is between $300 and $400, would likely go up between $100 and $200 per head, he said.
¡°The farmers that we work for are depending on us to process the meat for them to sell it,¡± Smucker said. ¡°If the processing costs are too high, they can¡¯t sell it. They would have to send it out to auction or do something else.¡±
Ron Fouche of Seltzer¡¯s Smokehouse Meats in Palmyra, Pa., said the revisions would not cause as great of an impact to his business because it sells only one product.
But he is not clear as to what the government actually wants.
¡°I hope brains are attached to their heads down there in Washington,¡± Fouche said. ¡°I¡¯m confused by it. What are they looking for. In my opinion, what they put together is rather vague.¡±
Brian Snyder, executive director of the Pennsylvania Association for Sustainable Agriculture (PASA), said the revisions are another example of a broken system hurting small operators.
¡°We¡¯re very concerned about it. They are tuning up food safety all across the board and whenever that happens, it always seems to hurt the small operators,¡± he said. ¡°There is no secret that this is in the interest of larger players.¡±
Wenther said large operators would have to abide by the same rules.
In fact, in the revisions, it states that larger processors would have to provide samples consistent with their level of production.
Whatever the impact, Wenther said the revisions contradict the USDA¡¯s push for more locally produced foods.
¡°I think overall, you¡¯ll see the whole ¡°know your food, know your farmer¡± thing hurting them, because (farmers) will not have the place to take their products. More of these small processors will go out of business,¡± he said. ¡°It will be harder and harder for these producers to find plants where they can direct-market their products.¡±

Raw milk: Personal decision or public danger?
Fans of unpasteurized dairy say it¡¯s healthier
scientists and regulators call it unsafe
April 22, 2010|By Julie Deardorff and Tim Jones, Tribune reporters
Most of the milk from the dairy cows on South Pork Ranch ends up pasteurized ? heat-treated to reduce the chance that the people who drink it will get sick.
But every month, 300 gallons of the milk are sold raw, much of it to about five dozen regular customers who arrive at the central Illinois farm toting their own containers to tap the creamy drink from a squat, stainless-steel vat in a room next to the milking stalls.
That choice has put the farm's owners, Keith Parrish and Donna O'Shaughnessy, at the center of a particularly American food fight between passionate defenders of personal choice and health officials who warn that drinking farm-fresh milk can be life-threatening.
The federal government and virtually all public health agencies oppose consumption of raw milk because it can carry dangerous bacteria including E. coli 0157:H7, listeria and campylobacter. Last month, 13 people in Michigan were sickened by campylobacter in an outbreak tied to raw milk sold at a northern Indiana farm.
Raw milk drinkers argue that they should be allowed to decide whether to take the risk. Many who drink raw milk believe the unprocessed, nonhomogenized version is more nutritious and can help with ailments such as allergies, asthma and gastrointestinal issues, though public health agencies and nearly every major medical association in the country say those benefits are unproven.
"It's more than a health issue; it's a human rights issue," said Kathryne Pirtle of Addison, a professional musician who credits raw milk with eliminating the chronic pain she experienced for 25 years. "Real food and the raw milk movement are the answers to our health care crisis and the future of our populations."
The FDA bans interstate sales of raw milk, but states regulate its sale within their borders. Sales are now legal in 27 states under some circumstances, with bills to legalize it pending in Georgia and Wisconsin. In several states, including California, Connecticut and Pennsylvania, raw milk can be sold in retail stores.
In Illinois, consumers who want raw milk must take their own containers directly to the farm. Another option is a cow share, in which a consumer contracts with a farmer or "milk club" operator to buy a share of the animal. As part-owner, the customer is entitled to some of the cow's milk.

BPA Poses New Risk To Food Safety ? Legislative Impasse
April 26, 2010
By Scott Hensley
Legislation that would give the Food and Drug Administration more power to safeguard the food supply is in danger of being tripped up by controversy over the plastic additive bisphenol A.
The chemical, BPA for short, is commonly used in hard plastics and coatings inside cans of foods and drinks. Worries about BPA's potential to harm health led the FDA to express concern about its safety and the Environmental Protection Agency to say it is taking a closer look, too.
Sen. Dianne Feinstein of California wants to ban BPA's use in food containers, telling Politico, "I feel very strongly that the government should protect people from harmful chemicals." Her move to legislate a BPA ban is causing waves on food safety.
The Washington Post reports, business groups that had lined up behind food safety legislation warned they don't like Feinstein's idea at all. In fact, they've written to Sens. Tom Harkin (D-IA) and Mike Enzi (R-WY), on the Senate health committee to say they'd withdraw support for a food safety bill passed by the House last year, if the Senate version includes Feinstein's BPA ban, the Post says.
A survey by Consumer Reports last year found quite a bit of BPA in canned foods. With the health effects still a matter of some debate, the National Institutes of Health is slated to spend about $30 million on new studies of BPA, with results expected to start coming in about a year and half from now.
Opponents of Feinstein's amendment say it would be premature, given the BPA work underway, especially FDA's. "We trust the FDA to complete a safety assessment for BPA, and we don't think the Senate should short-circuit and undermine the FDA," Grocery Manufacturers Spokesman Ken Faber told the Post.

Will the USDA doom locally produced meat?
New testing regulations may end small-scale meat production -- and keep the market safe for the big boys
By Sara Breselor
That wailing you hear in the distance is the sound of small meat processors begging the USDA for mercy. The U.S. Department of Agriculture's Food Safety Inspection Service recently proposed a set of new regulations that will require all meat processors to submit their products to a new series of tests, a procedure that can cost hundreds of thousands of dollars for even a modestly scaled operation, enough to cripple many small processors.
What worries fans of small farms and locally produced food is that the closing of small processors will mean the closing of small farms. Slaughter and processing is the biggest challenge for small-scale meat; they're operations simply too costly and complex for farms to handle themselves. As it is, farmers have few options for meat processing without selling their animals to massive feedlot-meat operations, and without that piece of the puzzle, many farmers may quit. Why is the USDA considering the new testing regime? Some producers wonder if the machinations of Big Food are in play.
"The new testing would just ensure that the current processes, which are based on scientific consensus, are working," according to Dustin VandeHoer of the Iowa Department of Agriculture and Land Stewardship. But, he adds that it's not clear why they're being mandated: "It doesn't appear that it's in response to any specific situation. They're just kind of reinterpreting the existing rules.'" And he's unsure that the new tests are necessary. "We haven't had problems with food safety, especially with the smaller plants," he says. "We should never become complacent, but I think we can reach a point where [small meat processors] can still be allowed to operate and food can be safe. I don't know that we need to be taking this path that's going to put small plants out of business." (Repeated attempts by Salon to solicit comments from the USDA were unsuccessful.)
Greg Higgins, chef/owner of Higgins Restaurant in Portland, Ore., and a founding member of the sustainability and local-food-focused Chefs Collaborative, has darker suspicions. "What's always in the back of my mind is the industrial food lobby," he says. He suspects that the change in the USDA regulations, and the way they will affect small meat producers, was probably "fairly well thought out by the lobbyists." The popularity of small farms, grass-fed meats, and artisan products like salumi and prosciutto is expanding rapidly, and Higgins suspects that the industrial food lobby is trying to squeeze producers out so as not to lose a share of the market."They don't want any competition," Higgins says. "They're very powerful and I think they would relish the opportunity to keep the market closed."
Mario Fantasma of Paradise Meats in Trimble, Mo., wants to trust the USDA. "I'm sure their intentions are good," he says, "but I don't think that they see far enough into what it can do to small companies -- and even large companies for that matter."
Higgins says that it's unfair for small plants to suffer when health safety risks are disproportionately linked to large-scale processing. "Think about all the big health scares we've had," he says. "They're all related to large-scale food production, whether it's spinach from a massive grower in California or ground beef out of the Midwest, they're all gigantic, they're never these little tiny plants."
And Fantasma argues that small plants are, by necessity, already more conscious about food safety. "At small facilities, we've always had food safety in our top priorities. We can't afford not to. If one of our customers came here and got sick, what do you think would happen to my business? That alone would kill us. It's common sense that we want to do everything in our power to make sure that our product is safe."
"The thing that's going to affect us is the cost of the testing," Fantasma says. Regulations for small plants like Fantasma's will require 13 samples of every product to be tested before processing, and another 13 samples after processing. "When you add all those products and tests, it racks up a super amount of money," he says. "Right now we're sitting at about $500,000 for the initial validation tests, just for the first year. We wouldn't be able to do it. It would just really devastate our business."
Fantasma recognizes the trickle-down effect of the new regulations. "It's not just about us, the processors. Look at what would happen to the farmers who are trying to offer their farm-raised products to their customers. [The USDA is] taking away their ability to market their own products. Their farms would wither up. They would have to go back to selling to commodity markets, whether they want to or not. And what's bad about it is that these guys raise some nice animals, hormone- and antibiotic-free. They work real hard for their living, trying to keep a sustainable farm running, and when you take their market away from them, it shuts them down."
The American Association of Meat Producers and the Iowa Department of Agriculture have both made public statements against the new regulations and have started a letter-writing campaign. VandeHoer is hopeful that the USDA will heed their concerns about the fate of small plants, and Fantasma says the letter writing is his only hope. "All we can do is go to them and say, 'Look, this is going to kill us.'"

Consumers have the final say, so let¡¯s hear from them
By Richard Raymond
Food (Safety) Fight (Meatingplace Blog)
What do fruit juice, milk, egg products and ground beef have in common? They are all produced by comingling product from hundreds of sources. Hundreds of eggs from many laying operations, broken into one large vat to eventually become a liquid or dried, shelf-stable product. One bad egg loaded with pathogens, and the whole lot could be contaminated. Hundreds of gallons of milk from many dairy farms dumped into one large vat. One bad gallon of milk and the whole vat could turn deadly. Hundreds of apples squeezed into juice. But first one falls to the ground and lands in a pile of you know what and the product may sicken many children getting their daily juice fix. And, of course, trim from hundreds of cattle, many farms and even a few countries being blended to get the perfect percent lean that the consumer wants. One contaminated carcass and we have another outbreak and subsequent recall.
Fruit juice, milk, egg products and ground beef. What do they not have in common? The final kill step to guarantee (almost) the safety of the product.
For 100 years milk has been pasteurized, a step that was instituted when dairy farms already had very high sanitation levels, but the product was still making people fall ill. It was fought then, and today people still have a choice of pasteurized versus raw milk. And those drinking raw milk because they feel pasteurization decreases nutritional value or changes the composition of the milk often suffer food-borne illnesses.
In 1970, the Egg Products Inspection Act was passed and the industry changed for the better, including routine pasteurization of egg products. Not because the eggs going into the product were necessarily bad, (in fact the Act mandated that they be safe and wholesome) but because the comingling increased the chance of one bad egg turning a whole batch bad.
And talk about one bad apple changing an industry! It is just in recent years that fruit juices also benefit from almost routine pasteurization because of a serious outbreak caused in part by commingling product. But does the average consumer even understand that they should read the juice label to be certain they are buying the safest product, or do they go for the least expensive?
Some shell eggs are pasteurized, and some ground beef products are pasteurized, but those that are make up a minority. When will the consumers demand that the vast majority of these two products that still carry a relatively high risk of contamination be pasteurized and labeled so we can make an intelligent (or not so intelligent) selection of foods for our tables?

April 26, 2010

Comic Book Teaches About Food Poisoning
by Alexa Nemeth | Apr 27, 2010
The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) now has a Web page specifically for kids' and teens' food safety education.
This Website has everything from comic books, word searches, and puzzles, to coloring and activity pages. There are also easy to read articles about food safety designed to engage kids and teens.
The comic books aim to deliver information through easy to understand principles and fun story lines.
One of the comic books, Let Me Tell You How Dad Got Sick (URL: ), is particularly engaging. It is scripted like a comic book, and is at a fairly easy reading level. It's both a fun and exciting way for kids and teens alike to learn about food safety.
In the comic book, a young boy tells the story of how his dad became ill after eating chicken that had been left on the counter for a long period of time. Near the end of the story the doctor explains to the family why the Dad was sick and how his illness could have been prevented by refrigerating the chicken within two hours of cooking it.
This comic book is quite short; only about eight pages, which keeps children interested while teaching them important food safety principles.
Let Me Tell You How My Dad Got Sick focuses on the principle of preventing illness from spoiled food. Towards the end of the comic there is a chart with different types of food and the length of time they can be in the refrigerator and freezer before going bad.
FSIS has also provided four simple steps to prevent foodborne illness. These steps are also illustrated using the characters from the comic book. These steps include washing your hands for 20 seconds, keeping raw foods away from ready to eat foods, cooking food to safe internal temperatures, and placing leftovers in the refrigerator right away.

N.Y. senator wants non-O157 STECs deemed adulterants in beef
By Tom Johnston on 4/27/2010
Sen. Kirsten Gillibrand (D-N.Y.) is urging USDA to deem an additional six strains of E. coli as adulterants for which the agency must test in beef products, contending they are as hazardous as E. coli O157:H7.
In a letter to Agriculture Secretary Tom Vilsack, Gillibrand asked that USDA also list non-O157 Shiga Toxin-producing Serotypes of Escherichia coli (non-O157 STECs) as adulterants, recognizing the "scientific and legal bases" for doing so as detailed in two petitions to the agency's Food Safety and Inspection Service.
A group called Safe Tables Our Priority (STOP) is leading the petition campaign.
"Such listings will avoid the same kind of large-scale disaster that precipitated the 1994 declaration of E. coli O157:H7 as an adulterant," the senator wrote in the letter. "S.T.O.P.'s petition also calls for the expansion of the definition of adulterant to include E. coli O157:H7 and these six other STEC when they are in any type of beef, not just ground beef or beef intended for ground beef."
Gillibrand contended in a news release that non-O157 STECs "are just as hazardous as E. coli (O157:H7)." She noted the Centers for Disease Control and Prevention estimates that these other strands cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in the United States every year.
Last fall, Gillibrand proposed the E. coli Eradication Act, which would require all meat plants to test beef before and after it is ground. (See Senator poses E. coli Eradication Act, Meatingplace, Oct. 15, 2009.)

Q&A: NSAC Policy Director on S. 510
by Chuck Jolley | Apr 28, 2010
Ferd Hoefner, Policy Director, National Sustainable Agriculture Coalition (NSAC), talks about S. 510, the FDA Food Safety Modernization Act.
The contents of the FDA Food Safety Modernization Act represent a major new approach to food safety. Looking at it with the customary cautious optimism characteristic of many food trade organizations is the National Sustainable Agriculture Coalition. Few people doubt that a fresh approach to the nuts and bolts of a sane and effective program is necessary and the need to get it done is immediate. It's the details that can kill it.
The real test will be the FDA's ability to execute the program, whatever the final bill might contain. Any increase in oversight requires a corresponding increase in manpower and cash, something the Feds have too often been unwilling to supply. It's a problem recognized by the National Sustainable Agriculture Coalition. I asked Ferd Hoefner, their policy director, to talk about his concerns.
In Part I, Hoefner talks about what the National Sustainable Agriculture Coalition likes about S. 510, what concerns the coalition has with the bill, and whether proposed amendments to S. 510 that have been introduced to help small, sustainable agriculture will jeopardize food safety.
Q: A recent Food Safety News article about the food safety bill wrote about 'important improvements' urged by your organization (See Farmers Gain in Senate Food Safety Battle, April 15). Let's look closely at the FDA Food Safety Modernization Act. What provisions can the National Sustainable Agriculture Coalition applaud and what were the points that concerned you as a spokesperson for small, sustainable organic agriculture?
A: The bill that was passed out of the Health, Education, Labor and Pensions (HELP) Committee last November included practical, common sense improvements to the Produce Standards section of the bill that simultaneously improve food safety outcomes and support a stronger family farm system. These Committee-approved amendments include provisions to require the FDA to coordinate with USDA, EPA, and Fish and Wildlife Service to ensure that any on-farm food safety standards they develop are not in conflict with conservation and environmental standards. It also includes strengthened language requiring science-based risk analysis before proceeding to regulations.
The changes from Committee markup also include language directing FDA to consider farm scale and diversity issues as well as special consideration for certified organic farms and ranches and language instructing FDA and USDA to coordinate to establish food safety standards that are relevant to certified organic production.
These provisions make sense because they recognize that conservation practices many farmers use to mitigate food safety risks by establishing vegetative buffers that can filter pathogens from streams and runoff and protect cropland from windborne pathogens. FDA sensitivity to farm scale and diversity will also be critical. Ensuring that new food safety regulations do not undermine existing National Organic Program food safety standards helps protect the market viability of one of the fastest growing sectors in the American agriculture.
Farmers are concerned with more than just the Produce Standards section of the bill, however. The remaining improvements the National Sustainable Agriculture Coalition hopes to see in the final legislation include:
i) Adopting a risk-based approach to farm facility regulation that recognizes the broad spectrum of types of farm facilities and tailors requirements to the degree of risk that the operations could introduce into the food system.
ii) Directing FDA to reduce the amount and type of regulation and paperwork for farm facilities and for farms subject to produce standards so that food safety goals are met without creating such a complex system that it would be financially unsupportable except by very large or non-diverse farms.
iii) Ensuring that traceback requirements are practicable for farmers, including recognizing that direct marketers and identity-preserved products have traceability inherent in the market relationship and so should be exempted from further record keeping and that farmers should just be required to maintain records on the first point of sale beyond that farm gate.
iv) Including a new authority for a USDA-delivered competitive grants program for food safety training for farmers, small processors and wholesalers to help translate rules and guidance into the real world of farming and local and regional food systems.
Q: Proponents of a stronger food safety bill are delighted that both the House and Senate version of the bill give the FDA 'mandatory recall authority, require more frequent inspections, and ask food facilities to implement food safety plans.' You want a lessening of the bill's requirements for small producers. First, define 'small producer' and then talk about the reasons behind your position.
A: First, we support mandatory recall authority.
Second, we want FDA to do a rulemaking, open to public comment and based on a scientific risk analysis, to determine which farming activities and on-farm processing activities are high risk and therefore truly require that farmers develop expensive HACCP-type plans, regular on-farm FDA inspections, and full-scale traceback requirements beyond basic recordkeeping of farmgate sales. The bill reported by the Senate Committee, and the House-passed bill, did not require such a rulemaking. Many farmers will be surprised that things they may well consider normal farming activities that carry little or no food safety risk will make them subject to major new regulatory requirements with substantial new costs involved.
The Senate sponsors of the bill have now agreed to incorporate a proposal sponsored by Senator Sanders of Vermont to require FDA to do such a risk analysis and publish a rule for public comment, with direct authority to exempt or modify new regulatory requirements for low risk on-farm activities. This is an important, common sense improvement to the bill--it reduces unnecessary regulatory burdens on farmers while focusing precious FDA human and financial resources on high risk activities. Hence, it will help produce better real world food safety outcomes.
Third, we did not ask for this provision to be limited to farms that qualify as small businesses, nor did Senator Sanders to our knowledge. That restriction came from FDA and the staff of the bill's sponsors. It was agreed to in the process of negotiation.
Q: Improvements in food safety, first and foremost, is the goal of the bill. According to the Food Safety News article, an amendment sponsored by Senator Michael Bennet (D-CO) is "intended to reduce paperwork and excess regulation and FDA will be instructed to provide flexibility for small processors including on-farm processing, minimize the burden of compliance with regulations, and minimize the number of different standards that apply to separate foods.
"FDA will also be prohibited from requiring farms and other food facilities to hire consultants to write food safety plans or to identify, implement, certify, or audit those plans." While it certainly gives the little guy a significant break financially, doesn't it also unnecessarily expose the public to health risks?
A: Like the Sanders amendment, the Bennet amendment is an important, common sense provision that improves the bill. Without the new Bennet language, the bill would require FDA to do separate food safety regulations on each crop even if a substantial amount of the rule would be common across all or most crops. It would have also required separate rules even where a single rule for a particular category of crops makes more sense.
In our view, it is very important that the bill, as amended by Senator Bennet, now directs FDA to reduce unnecessary paperwork burden on farmers and small processors. It is also very important that the legislation is clear that FDA as a general rule will not require food facilities, including farms that are declared food facilities, from hiring expensive consultants or auditors. FDA has always said that was never its intent, but now that statement of intent is actually in the bill, where it appropriately belongs.
Editor's Note: This article was written by Chuck Jolley, special to Food Safety News.
See Food Safety News tomorrow for Part II of the discussion about the FDA Food Safety Modernization Act.

FDA¡¯s Michael Taylor Preaches ¡®Scale Appropriate¡¯ Food Safety Standards, Code Words For Exempting Small Farmers And Organics

Michael Taylor, the FDA Deputy Commissioner for Foods, addressed a general session audience at the United Fresh Produce Association Convention in Las Vegas.
Pundit readers might be familiar with Mr. Taylor, as we ran his extensive testimony to Congress when he was Research Professor at The George Washington University School of Public Health and Health Services in an article titled: FDA Gets Blueprint Blueprint For Future, Incentive Change Might Lead To Safer Food.
Mr. Taylor is something of a hero to folks in the ¡°food safety community.¡± We explained why back in 2007, when we wrote a piece titled, Pundit¡¯s Mailbag ? Consumer Has Shared Responsibility In Food Safety, which featured a letter from Bardin Bengard, President of Bengard Ranches. The letter pointed out, correctly, that when it comes to food safety: ¡°There is no substitute for consumers doing their part by looking at the product and using proper methods of preparation.¡±
We responded by saying that though this point was true, it wouldn¡¯t matter in the end and the reason was Michael Taylor:
¡Šas sympathetic as we are to the notion that the industry is wise to urge all sectors to do their part, we have a sense that the industry is standing athwart history on this one.
If consumer participation in food safety could be expected or mandated, then E. coli 0157:H7 in hamburger would not be a beef industry issue. It would always be the consumers or the restaurant¡¯s fault for improperly cooking meat if anyone got sick.
Yet in the years following the 1993 Jack-in-the-Box outbreak, there was a clear shift away from this perspective. In mid-1994 a man named Michael Taylor was appointed as Chief of the USDA¡¯s Food Safety and Inspection Service. Shortly thereafter, on September 29, 1994, Taylor said that the USDA would from that date forward regard E. coli O157:H7 in raw ground beef as an ¡°adulterant,¡± because the epidemiological evidence showed that in the hands of consumers it was ¡±ordinarily injurious to health¡± ? thus it was an adulterant that should never, ever be present in the product.
In mid-October, 1994, Taylor announced plans to launch a nationwide sampling of ground beef to assess how much E. coli O157:H7 was in the marketplace. Five thousand samples would be taken during the year from supermarkets and meat processing plants ¡°to set an example and stimulate companies to put in preventive measures.¡±
A positive result would prompt product recalls of the entire affected lot, effectively removing it from any possibility of sale ? even though no one had gotten sick and consumers and restaurants could make the hamburger 100% safe just by thoroughly cooking it.
So even where there is a kill step, the rule has become that it is unacceptable to sell product that is dangerous.
Certainly this doesn¡¯t mean we shouldn¡¯t urge consumers and restaurants to do all kinds of things to keep food safe. Certainly we can continue to preach from the hymnal of shared responsibility.
Yet, at least on our fresh-cut product, we really have to ignore all that when it comes to our production specs.
And if down the road bulk produce starts causing people to get sick, don¡¯t expect a ¡°blame the consumer¡± strategy to carry much weight with regulators or the consuming public.
Although those on the Left have doubts about Michael Taylor ? his bio is deemed tarnished by some as he once worked for Monsanto, which makes him highly suspicious, if not certifiably evil, to a certain group of people ? his declaration of E. coli 0157:H7 as an adulterant in ground beef made him the pivotal person in shifting to an absolute industry responsibility standard in food safety and led many to cheer when he was appointed to this newly created FDA position 2009.
His speech at United was generally unexceptional. He called for all the things the produce industry associations have already endorsed: national food safety standards, applicable to imports, risk-based and sensitive to regional variations.
He called for dialogue, partnership and participation. He got nice applause.
Unfortunately, unless you are a policy wonk following the nuance of inside-the-beltway politics, you probably didn¡¯t realize that he was also using a DC code word for ¡°let¡¯s exempt certain competitors from food safety standards we demand of others.¡± That code phrase is ¡°scale appropriate.¡±
He said it many times, tried to express it as a concept still searching for a definition, and he asked for help in defining what it means.
Well, it is an odd thing to endorse a concept you don¡¯t know the meaning of, and we would say that this tortured quest for understanding is somewhat disingenuous, because it can only mean one thing.
¡°Scale appropriate¡± is a way of saying that in considering what food safety standards to apply, one is going to think of something other than food safety.
If one is serious about raising food safety standards, this is a triumph of politics over science.
Everyone accepts that ¡°one size fits all¡± food safety standards make no sense. So if there is a relevant difference, variable standards not only make sense, but are required. For example, imagine there is a greenhouse that uses municipal water ? that is to say fully potable drinking water that is already constantly tested by a municipal water system. To require that greenhouse to test that water at source, the way we might require someone using river water or well water to do, would be unfair, unnecessary, redundant and needlessly burdensome.
¡°Scale-appropriate¡± is an oxymoron when applied to food safety because there is nothing in the scale of the operation that impacts on food safety. It is a political term in which, depending on your point of view, you can say either that those who want food safety legislation are proposing to get it by buying off the votes of the numerically large number of small growers with a scientifically unmerited exemption or that the Obama administration doesn¡¯t want to annoy a politically important part of their coalition, the organic community.
All the arguments for exempting small growers from food safety regulations that apply to large growers are either not justified by science or logic or not related to food safety.
Typically advocates of such an exemption make one theoretical claim and one statistical claim:
The theoretical argument is that ¡°Joe, the small farmer, will not have food safety problems because he cares and won¡¯t sell, for example, crop that has had an animal intrusion in the field and won¡¯t allow, for example, a worker with a bad cold to work harvesting.¡±
We have no reason to think small farmers any more or less ethical than large farmers, but their situation is very different and it rebounds exactly the opposite of this assertion.
For a large agribusiness, policies are typically set and enforced dispassionately. The harvest chief, who sees pigs or cows in a field and pulls out his harvesting crews and machinery, is typically not impacted financially by that decision. Equally, the decision to send an employee home is not going to impact the income of the person making that decision.
In contrast, the small farmer is unlikely to be dispassionate about such a decision. This land is his livelihood and if he sees a pig run through it, his inclination is typically not to bankrupt himself by deciding not to harvest that year¡¯s crop. Nor, when all hands are needed, is he likely to want to start sending scarce workers home because someone has a cold.
The statistical argument is even weaker than the theoretical one. Advocates for exemptions for small growers from food safety standards will claim that the outbreaks are almost never traced back to small growers, only large ones. This is a statistical quirk. Most people who get sick in food safety outbreaks are never identified to the authorities; they get a stomach ache and then get better. This means that a typical outbreak has very few known sick people.
The problem in the statistics thus becomes obvious. If the sale of a few million servings of a produce item by a giant producer only produces an outbreak with a couple hundred known illnesses, a small grower ? if his product is contaminated to the precise same percentage as the large grower ? will produce too few known illnesses to ever be traced back.
Typically outbreaks are identified because the sick people answer survey questions differently than a base study of healthy people. So if, typically, 10% of the population has eaten raw spinach within the past 72 hours and a group of sick people show that 99% of them had eaten spinach within the 72 hour period, that is a strong indication that they are sick due to spinach or something associated with spinach ? say bacon bits. But you need a critical mass of people sick to answer the survey and contrast with the control survey. If you only have one sick person, the survey isn¡¯t that helpful.
Everything we know about food safety gives us reason to think food safety issues affect producers large and small. If Michael Taylor and the administration want a ¡°scale appropriate¡± exemption for small growers, it is because they have abandoned honesty about food safety in a quest to get the authority they yearn to give government.

FSIS, Mexican counterpart sign pact to improve interaction
By Tom Johnston on 4/28/2010
USDA's Food Safety and Inspection Service on Tuesday announced it has signed an agreement with Mexico's National Service of Health, Food Safety, and Agro-Alimentary Quality (SENASICA) that outlines a procedure for interaction between the two agencies.
"FSIS has been working diligently with SENASICA on this agreement to improve how we work together," FSIS Administrator Al Almanza said in a news release. "Through the cooperation of SENASICA, we can jointly continue to enhance our efforts in ensuring food safety and protecting public health."
The document, "Terms of Reference for the Operational Relationship of the Mexican National Service of Health, Food Safety, and Agro-Alimentary Quality and the United States Food Safety and Inspection Service in the Trade in Meat, Poultry and Egg Products Between the United Mexican States and The United States of America," focuses on matters of equivalence, audit procedures, the listing and delisting of eligible establishments for export to the two respective countries, and establishing more effective means of communication in areas of public health. Almanza and SENASICA Director in Chief Enrique Sanchez-Cruz signed the agreement on behalf of their respective governments.
The agreement aims to improve established procedures. FSIS and SENASICA worked together after the latter's request to FSIS for written standard procedures by which the agencies interact on matters of food safety and public health.
To view the full written procedural agreement, click here (URL: ).

Q&A: NSAC Policy Director on S. 510, II
by Chuck Jolley | Apr 29, 2010
Ferd Hoefner, Policy Director, National Sustainable Agriculture Coalition (NSAC), talks about S. 510, the FDA Food Safety Modernization Act. Part II: On traceability and recordkeeping, exemptions for small food facilities, and S. 510 in its current form.
Q: Update me on the negotiations over Senator Sherrod Brown (D-OH) amendment to the traceability and recordkeeping section of the bill. What were the details of the amendment and were all parties able to reach an agreement?
A: Senator Sherrod Brown's office has been working on an amendment to ensure FDA full and speedy traceability in the case of a food safety emergency. The National Sustainable Agriculture Coalition has worked with the Senator's office to craft language that would not reduce FDA's ability to identify the source of contaminated food but would recognize the different ways that food moves in the US food system. For example, farmers selling at farmers markets cannot be expected to keep track of the names and addresses of all the customers they sell to directly but that does not create a problem because in the unlikely event that someone should get sick the customer knows where the product came from--the direct relationship between the producer and the consumer is the best protection and further recordkeeping would be unnecessary. The negotiations are continuing on the amendment and we have not seen final language, but we trust issues related to direct marketing and to farm identity-preserved marketing will be dealt with appropriately.
Q. Senator John Tester (D-MT), wants to exempt food facilities with under $500,000 gross sales from preventative control plan requirements, and traceback and recordkeeping provisions. It gained strong support within the sustainable Ag community and it's based on the assumption that locally grown foods are inherently safer. Do you agree?
A: The current FDA regulations in our view make little sense. All farms that would otherwise be declared food facilities by FDA because of specific normal farming activities or on-farm value-adding processing activities are currently exempt from all requirements on all of their production if more than 50 percent of their gross sales are direct sales to consumers. From the farmer perspective, an operation with substantial direct sales may be over 50 percent one year, and under 50 percent the next year depending on markets and other variables. From the government perspective, there are no government statistics at FDA or USDA or anywhere else that track the amount of sales made directly to consumers. In a word, the current regulation is impractical and perhaps also illogical. The Tester approach is a great improvement over the current situation and in our view could be further improved to make it even more practical.
Support for the Tester amendment does not rise or fall on whether one supports local food systems or not. Current FDA regulations, which are assumed by S. 510, presume that local, directly purchased food is safer. But it is impractical. The Tester amendment creates a practical standard, but in no way ties it to either local food or to direct purchase. So in reality it is current law, not the Tester amendment, which is based on assumptions about the safety of local food.
Q: Quoting several people in the Food Safety News story, Farmers Gain in Senate Food Safety Battle, David Acheson, former associate commissioner of foods at FDA, sees no solid evidence that unconventionally-grown food is microbiologically safer and said Tester's proposal goes too far. "It is asking for trouble...and it is not sound public health policy," he said. Tony Corbo, a lobbyist for Food & Water Watch, pointed out that, based on the 2007 Agriculture Census released by the USDA last year, nearly 95 percent of domestic farms would be exempt. To me, it seems to leave an enormous amount of the nation's food production unregulated. How should the issue of food safety be managed by those producers?
A: What is Food & Water Watch's view on how many farms are exempt under current FDA regulation? The answer is they don't know. Neither does FDA, or anyone else. What they do know, but choose to obfuscate, is that 75 percent of the market value of all agricultural products are from farms with over $500,000 gross sales. So yes, 95 percent of all domestic farms, but representing just a quarter of total product, would be exempt under Tester. However, even that understates the case, as that is for all of agriculture, and the bill does not deal with livestock at all and it emphasizes specialty crops in particular.
The percentage of the market value of specialty crops that would be exempt under Tester is far smaller than for agriculture as a whole. So Food & Water Watch should stop playing fast and loose with numbers. More importantly, the proposed Tester-crafted exemption is more practical and makes more sense than the existing FDA-crafted exemption. Both, on the other hand, could be improved.
Q: Let's wrap it up. What do you think about the bill in its current form?
A: Watching the evolution of the FDA Food Safety Modernization Act has been an interesting experience. National Sustainable Agriculture Committee members approached the process with deep misgivings but have been impressed by the genuine bipartisan commitment to crafting meaningful legislation. However, in our view, the bill's supporters and even its detractors do not generally say very much about the bill's cost. In a word, it is very high. If many of the promises in the bill are ever to become reality, it will take a very significant boost in congressional appropriations for the FDA budget. That being the case, it is paramount that everything that can be done will be done to focus the bill on the most pressing and important food safety concerns. Spreading the net too wide will doom the effort to failure, waste taxpayer resources, and not help create a safer food supply.
See Part I of the discussion from yesterday on what the National Sustainable Agriculture Coalition likes about S. 510, what concerns the coalition has with the bill, and whether proposed amendments to S. 510 that have been introduced to help small, sustainable agriculture will jeopardize food safety.
Editor's Note: This article was written by Chuck Jolley, special to Food Safety News.

More on Hawaii/Tuna/Salmonella: national outbreak? international?
Posted on April 22, 2010 by Drew Falkenstein
From today's Hawaii Department of Health press release:
The Hawai¡®i State Department of Health (DOH) has confirmed 10 cases of
illness occurring on O¡®ahu caused by Salmonella Paratyphi B infection related to eating previously frozen internationally imported raw ahi. The individuals, who became ill, reported eating raw ahi (often prepared as poke) purchased or served at various locations on O¡®ahu.
As of April 12, 2010, there were 13 laboratory confirmed cases with the same S. Paratyphi B pattern in five other states: California (7), Maryland (2), Pennsylvania (2), Massachusetts (1), and New York (1). DOH is working with the U.S. Centers for Disease Control and Prevention (CDC) and the other states to identify if those cases were also exposed to raw ahi. DOH has informed the U.S. Food and Drug Administration (USFDA) and requested an investigation of international sources of frozen raw ahi.
¡°The Department of Health is concerned about these cases that are similar to a cluster of cases we investigated two years ago,¡± Health Director Dr. Chiyome Fukino said. ¡°With the help of the USFDA, we hope to identify the source so we can prevent any further illness."
Between October 2007 and February 2008, DOH identified a total of 35 confirmed cases of Salmonella Paratyphi B infection on O¡®ahu. An exhaustive investigation by the department identified raw imported frozen ahi used in ahi poke as the probable source of illness. At that time, confirmation of additional cases in Colorado and California related to the consumption of raw fish prompted an investigation by the USFDA, but a definitive source for the implicated ahi could not be identified.

Memories of Mad Cow Scare
APRIL 29, 2010 07:25
Today marks the second anniversary of MBC¡¯s airing of an investigative report on U.S. beef over fears of mad cow disease. Spurred by the report and groundless Web rumors about the disease, groups of female students took to the streets on May 2, 2008, holding candles. A coalition of leftist groups opposing U.S. beef imports came to the fore four days later and organized the protests. The movement escalated into a campaign to oust the Lee Myung-bak administration, which had recently been inaugurated. The protests plunged central Seoul into violent and lawless chaos for more than three months.
At the time, the protesters seemed to believe the argument that consumption of U.S. beef would instantly cause mad cow disease and that 94 percent of Koreans were genetically vulnerable to the disease. American beef, however, accounted for just 26.5 percent of imported beef sold in the Korean market last year, a figure that grew to 33.3 percent in the first two months of this year. Despite the lingering aftereffects of the beef protests, fears over U.S. beef are rapidly disappearing.
Where are those who lauded the protests as ¡°agora democracy¡± and ¡°direct democracy?¡± The protests that shook Korean society two years ago have been forgotten too easily without thorough research and analysis. The demonstrations, through which certain leftist groups drove the country into madness for political purposes, remain a sore memory. Time is needed to calmly reflect on the incident to achieve true democracy.
The Lee administration hid itself throughout the protests. Rather than standing up against the ungrounded agitation and false information in a dignified and cool-headed manner, it went as far as to kowtowing to the violent and illegal activities of the protestors. The government simply did nothing about the anarchic situation for 106 days until the protests lost steam in mid-August 2008. Prosecutors published a white paper on their investigation into the illegal and violent disturbances last year to mark the first anniversary of the incident. That was not good enough, however.
The government should humbly reflect on what lessons it learned from the experience and how it strengthened its ability to overcome a crisis. Britain, which suffered from an outbreak of mad cow disease in the 1980s, issued a report on BSE in 2000. The Korean government should consider publishing a BSE candlelight protest report this year to hand down the lessons to future generations.

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