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food@foodsafetyinfo.net

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6/30/2009

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source : http://www.todaykorea.co.kr
ÀÛ¼ºÀÚ : Ã̶ֹó ±âÀÚ mil0726@todaykorea.co.kr
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ÀÛ¼ºÀÏ : 2009.06.25 10:05
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Nestle Unit Denied FDA Requests
Source of Article: http://online.wsj.com/article/SB124597272999657145.html

By JANE ZHANG
The Nestle USA plant at the center of a federal probe into an E. coli outbreak involving cookie dough refused to give inspectors access to pest-control records, environmental-testing programs and other information, according to newly released inspection reports covering the past five years.
In a September 2006 visit, for example, managers at the Danville, Va., plant refused to allow a Food and Drug Administration inspector to review consumer complaints or inspect its program designed to prevent food contamination. The inspector found dirty equipment and "three live ant-like insects" on a ledge but nothing severe enough to give the plant a failing grade.
A year earlier, officials at the Nestle plant presented another FDA inspector with a list of things it wouldn't do. "Among these are the refusal to review the firm's consumer complaint file, refusal to permit photography, refusal to sign affidavits or receipts and refusal to provide specific information on interstate commerce," the inspector wrote.
Companies aren't required to show those records to FDA inspectors and Nestle's practice isn't out of line with the rest of the food industry, FDA and industry officials said.
Nestle USA spokeswoman Edie Burge said she couldn't immediately comment on the reports Thursday, but said the company is cooperating with the FDA investigation. Since Friday, she said, the FDA has been examining all production and environmental records and testing finished dough samples, but hasn't found any contaminations there.

Nestle USA, a unit of Switzerland-based Nestle SA, suspended cookie-dough production at the plant June 18, but has continued to make pasta and sauce there, Ms. Burge said. The company has recalled 300,000 cases of refrigerated cookie-dough products.
David Elder, director of regional operations at the FDA's Office of Regulatory Affairs, said many food companies do open their records to inspectors. But the agency, he said, doesn't have explicit authority to access any records during regular food-safety inspections, with the exception of infant formula, seafood, juices and low-acid canned food.
The FDA can inspect the records if it invokes a bioterrorism law and shows that the agency has "a reasonable belief" that the foods pose serious health threats -- a high bar to cross.

The reports, released by the FDA in response to a Freedom of Information Act request by The Wall Street Journal, come as FDA investigators comb the Danville plant for clues to the E. coli outbreak in 29 states that sickened at least 69 people, including 34 who ended up in the hospital. Most of those sickened were teenage or preteen girls, and no deaths have been reported.
Legislation moving through the House would require food companies to keep more records and give FDA inspectors access to all records during inspections. The House Energy and Commerce Committee recently approved it, but it isn't clear when the House will vote on it. Similar legislation has been introduced in the Senate.
The legislation would "really change the dynamics of the situation" on record access by the FDA, said Stuart Pape, managing partner at Patton Boggs LLP who has represented the food industry for 35 years.


Nestle Plant Refused Full Cooperation with FDA
Source of Article: http://www.foodpoisonjournal.com/
Posted on June 26, 2009 by Denis Stearns
Two reports of past inspections were made public today. The most notable inspection occurred in September 2006 at the Nestle plant in Danville, Virginia where it manufactures cookie dough products, as well as stuffed pastas and pasta sauces. A number of deficiencies were noted as part of the inspection. These were:
Three live ant-like insects were observed on a ledge along the W wall of the powdered sugar dump station in the cookie dough manufacturing area.

Dirty stainless steel equipment and utensils were observed in a bin which was identified as "clean" in the cookie dough cleaning area.
Water or other clear liquid was observed dripping from an overhead line in the liquid egg receiving bay.
The knock off ann for the check weigher was improperly timed or otherwise not functioning properly to remove trays of cookie dough on line ten.
More disturbing, however, is the refusal by the plant to give FDA inspectors access to important food safety related documents and information, including:
Percent ofproducts which move in interstate commerce
Review of complaint log
Use of camera
Review ofpest control records
Review ofHACCP program
Information on environmental testing program

This is troublingly reminiscent of the Peanut Corporation of America, which also refused to give access to important records, forcing the FDA to invoke the Bioterrorism Act of 2002.
A copy of the FDA Inspection Report can be found here: www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM169114.pdf

William Marler Opinion - Who Poisoned Our Cookies With E. coli?

Source of Article: http://www.foodpoisonjournal.com/
Posted on June 27, 2009 by Bill Marler

What if the cookie dough E. coli outbreak actually happened this way?
At 10:00 PM last night between yet another story about Michael Jackson¡¯s death, a foreign Network begin airing a video taken inside a manufacturing facility showing someone treating a batch of cookie dough with an unknown liquid. There is a claim that this is a terrorist act.

In the next 15 minutes, every network news operation is playing the video. The broadcast networks break into regular programming to air it, and the cable news stations go nonstop with the video while talking heads dissect it. Michael Jackson fades into the distance.

Coming on a Friday evening on the East Coast, the food terrorism story catches the mainstream Media completely off guard. Other than to say the video is being analyzed by CIA experts, and is presumed to be authentic, there isn¡¯t much coming out of the government.
Far-fetched? Don¡¯t count on it. I have been saying for years that a foodborne illness outbreak will look just like the terrorist act described above, but without the video on FOX News. Far-fetched?
Tell that to the 751 people in Wasco County, Oregon?including 45 who required hospital stays---who in 1984 ate at any one of ten salad bars in town and were poisoned with Salmonella by followers of Bhagwan Shree Rajneesh. The goal was to make people who were not followers of the cult too sick to vote in county elections.
Tell that to Chile, where in 1989, a shipment of grapes bound for the United States was found laced with cyanide, bringing trade suspension that cost the South American country $200 million. It was very much like a 1970s plot by Palestinian terrorists to inject Israel¡¯s Jaffa oranges with mercury.
Tell that to the 111 people, including 40 children, sickened in May 2003 when a Michigan supermarket employee intentionally tainted 200 pounds of ground beef with an insecticide containing nicotine.
Tell that to Mr. Litvenenko, the Russian spy poisoned in the UK with polonium-laced food.

Tell that to Stanford University researchers who modeled a nightmare scenario where a mere 4 grams of botulinum toxin dropped into a milk production facility could cause serious illness and even death to 400,000 people in the United States.
The reason I bring this up is not to mark another anniversary of 9/11, not because I actually think that food terrorism really is the cause of this week¡¯s E. coli cookie dough outbreak, but I wonder if it would have made any difference in our government¡¯s ability to figure out there was an outbreak, to figure out the cause, and to stop it before it sickened so many.
After 9/11, Health & Human Services Secretary Tommy G. Thompson said: ¡°Public health is a national security issue. It must be treated as such. Therefore, we must not only make sure we can respond to a crisis, but we must make sure that we are secure in defending our stockpiles, our institutions and our products.¡±
Before Thompson¡¯s early exit from the Bush Administration, he did get published the ¡°Risk Assessment for Food Terrorism and Other Food Safety Concerns.¡± That document, now 5-years old, let the American public know that there is a ¡°high likelihood¡± of food terrorism. It said the ¡°possible agents for food terrorism¡± are:

- Biological and chemical agents
- Naturally occurring, antibiotic-resistant, and genetically engineered substances
- Deadly agents and those tending to cause gastrointestinal discomfort
- Highly infectious agents and those that are not communicable
- Substances readily available to any individual and those more difficult to acquire, and
- Agents that must be weaponized and those accessible in a use able form.

After 9/11, Secretary Thompson said more inspectors and more traceability are keys to our food defense and safety. To date, we¡¯ve made little movement to ensure this.

Would the fact of terrorists operating from inside a manufacturing facility somewhere inside the United States bring more or effective resources to the search for the source of the E. coli? If credit-taking terrorists were putting poison on our cookies, could we be certain Uncle Sam¡¯s response would have been more robust or effective then if it was just a ¡°regular¡± food illness outbreak?

Absolutely not! The CDC publicly admits that it manages to count and track only one of every forty foodborne illness victims, and that its inspectors miss key evidence as outbreaks begin. The FDA is on record as referring to themselves as overburdened, underfunded, understaffed, and in possession of no real power to make a difference during recalls, because even Class 1 recalls are ¡°voluntary.¡± If you are a food manufacturer, packer, or distributor, you are more likely to be hit by lightening than be inspected by the FDA. You are perfectly free to continue to sell and distribute your poisoned product, whether it has been poisoned accidentally or intentionally.
The reality is that the cookie dough E. coli outbreak is a brutal object lesson in the significant gaps in our ability to track and protect our food supply. We are ill prepared for a crisis, regardless of who poisons us.
Somewhere between the farm and your table, our Uncle Sam got lost.


The ¡®Guess Who Inspects It Game¡±: Nestle E. coli Cookie Dough Edition

Source of Article: http://www.foodpoisonjournal.com/
Posted on June 29, 2009 by Denis Stearns
The recent (and still unfolding) E. coli O157:H7 outbreak linked to contaminated Toll House cookie dough manufactured by Nestle has no shortage of lessons to teach, including the reminder that this deadly pathogen can find its way into nearly any food product if sufficient care is not taken during its manufacture. But this sad outbreak is also a case study in the ridiculously complicated, and too-often ineffective, state of food safety inspection in the United States. What makes the outbreak such an excellent case-study is the fact that the Nestle plant located in Danville, Virginia was not only manufacturing Toll House cookie dough products, but also a variety of Buitoni flat and stuffed pastas, and pasta sauces. This made the plant what is called a ¡°dual jurisdiction establishment¡± that fell under the regulatory authority of both the FDA and the USDA. And to make things even more interesting, Virginia Department of Agriculture and Consumer Services (VDACS) was performing routine plant inspections under contract with the FDA. So how come with all these agencies involved no one prevented the outbreak?

By way of background, the FDA has jurisdiction over all domestic and imported food products, except meat, poultry, or processed egg products, which fall under the jurisdiction of the USDA. But not all food products fall neatly on one side of the jurisdiction line or the other. For example, the products that Nestle manufactured for its Buitoni-brand fell on both sides of the line, with a few falling almost on the line. Meat-flavored pasta sauce would be inspected by the FDA, while meat sauce containing 3% or more of meat would be inspected by the USDA. The ravioli stuffed with cheese would be the responsibility of the FDA, while those stuffed with pork or prosciutto would be the responsibility of the USDA. Thus, if you look at the FDA Inspection Report from September 11 and 12, 2006, you will see that the inspector takes note of fettuccini and linguine being manufactured (FDA products), and chicken tortellini being manufactured (USDA product). Only the Toll House cookie dough products feel solely within the jurisdiction of the FDA. Nonetheless, the FDA plainly took note of all products being manufactured, without, however, making mention of whether or how what was found would be communicated to the USDA. Of course, since the USDA had an inspector onsite, and the FDA showed up in the plant only every year or so, it is the USDA that presumably knew much more about the plant.

Given the presence of the USDA in the plant on a daily basis, the obvious question then is what did the USDA know, and when did it know it? Another obvious question is: Could the USDA have prevented this outbreak from occurring? And, indeed, was it potentially in a better position to prevent this outbreak. (NOTE: As part of my firm¡¯s investigation into this outbreak we are currently attempting to obtain the USDA inspection records for this plant.)

For more, please click on the Continue Reading link.

The ineffectiveness of the FDA and USDA in these dual jurisdiction establishments was noted years ago. According to a March 2005 report by the General Accounting Office, there are 1,451 dual jurisdiction establishments in the United States?that is, plants that product food regulated by both the USDA and the FDA. (Other agencies that can have overlapping authority include the Environmental Protection Agency and the National Marine Fisheries Services.)

In analyzing how such dual jurisdiction work in practice, the GAO found that it imposes significant and unjustified burdens on the plants, failed to adequately coordinate inspection activities, and wasted large amounts of money through duplicative training programs for inspectors, and overlapping efforts that could and should be reduced. See GAO Report, www.gao.gov/new.items/d05213.pdf Indeed, the GAO specifically noted that the 2002 Bioterrorism Act granted the FDA authority to allow USDA inspectors to alone inspect the dual jurisdiction establishments, but that the FDA has never taken any action in this regard. Finally, the GAO reminded that it had for quite some time promoted the creation of a single food safety agency with jurisdiction over all food production in the United States, stating ¡°that improvements short of reorganizing the food safety system can be made to reduce overlaps and duplication, and to leverage existing resources.¡± GAO Report at 7.

Plainly effective coordination did not occur at the Nestle plant. The FDA personnel inspected the Nestle plant only every year or so (on 9/06, 9/05, and 7/04). The VDACS had inspected the plant on March 12, 2009, finding ¡°no unsanitary conditions,¡± but noting ¡°observed GMP deficiencies¡± on a state inspection report. (This is another report we are attempting to obtain.) The VDACS also inspected the plant twice in 2007, again under contract to the FDA. Whether the state of Virginia also had jurisdiction over the plant is right now unclear, but it appears to have also been inspecting the plant pursuant to its own jurisdiction.

Finally, as already noted, the USDA had an inspector onsite in the plant, but presumably the inspector stayed away from the part of the plant where the cookie dough was manufactured. This presumption is based on an USDA-FSIS Directive that states:

A. FSIS inspection program personnel are not to routinely enter or inspect an area of the establishment in which nothing that is subject to FSIS jurisdiction occurs. Inspection program personnel are to focus inspection toward the USDA regulated products. There may be situations where an FDA product is processed in close proximity to or on the same line as a FSIS regulated product, and, therefore, inspection personnel may be in the same area. In meat and poultry establishments the inspected facility is defined in the grant of inspection, and in egg products establishments the entire premises includes all buildings on the property.
B. If conditions in the area of the establishment that is only under FDA¡¯s jurisdiction may lead to, or are creating, insanitary conditions in the FSIS inspected areas of the establishment as described in 9 CFR 416.2, Establishment grounds and facilities, or in 9 CFR 590,
1. Inspection program personnel in meat and poultry establishments are to:

a. take the appropriate action with respect to FSIS regulated products as set forth in FSIS Directive 5000.1, Revision 1, Chapter I, Sanitation and Chapter IV, Enforcement , and
b. notify the District Office of the situation through supervisory channels.

See FSIS Directive 5730.1, www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5730.1.pdf The Directive also makes clear that the agencies are supposed to communicate with each other when ¡°foods produced in a DJE are implicated in outbreaks of foodborne illness,¡± but so far there has been no word yet whether such communication has taken place with regard to the Nestle Toll House cookie dough outbreak. It is also unclear what FDA policy is with regard to inter-agency communications related to an outbreak like this one.

In light of the foregoing, it is hard not to think of the story of the blind men and the elephant, with each inspecting only a part of the elephant, but none of them able to determine what it was they were inspecting, or reach any other conclusions. See ¡°Blind Men and an Elephant, Wikipedia, en.wikipedia.org/wiki/Blind_Men_and_an_Elephant Because each blind man knew only part of the truth, none of them were able to come to agreement as to the whole truth, even after they compared notes.

In thinking about our current story, the one where cookie dough made by Nestle poisoned dozens, I can¡¯t help but think of the FDA, USDA, and VDACS as three blind men inspecting an elephant. And perhaps the moral of our story is that it is long past time to have our food plants inspected by a single person, and one who is not blind.


House to consider food safety legislation after July 4

Source of Article: http://thepacker.com/
Published on 06/25/2009 12:48pm By Tom Karst

The House of Representatives plans to consider the Food Safety Enhancement Act of 2009 after July 4.
The United Fresh Produce Association, Washington, D.C., said in an e-mail to members June 23 that the food safety legislation is expected to be debated and voted on in early July, before the August recess.
The timing of Senate consideration is not known yet, as members there are dealing with health care reform.
Tom Stenzel, president of United Fresh, urged industry in the e-mail to stay engaged on the food safety issue through the summer and into the fall. In particular, he said the Washington Public Policy Conference Sept. 9-11 should provide attendees an opportunity to be involved the debate.
United Fresh has already worked to make the food safety more workable for the industry, Stenzel said. Since May, he said United Fresh has helped strengthen commodity-specific approach to fresh produce oversight, boost flexibility in traceability solutions and limited registration fees on domestics facilities and importers, among other improvements.
"As Senate leaders begin work on their own food safety bill later this year, we look forward to providing input that will result in passage of sound, scientific food safety legislation," Stenzel in the e-mail.


Food Safety Still Getting a ¡®D¡± in Obama Era, Despite Early Moves to Enter 21st Century

Source of Article: http://www.foodpoisonjournal.com/
Posted on June 25, 2009 by Food Poisoning Attorney
Consumer Confidence Has Crumbled Regarding Food Safety, Thanks to Massive Product Recalls...And That "D" Grade Is For Dangerous.
By Eddie Gehman Kohan, Editor in Chef of Obama Foodorama
A new study from IBM finds that sixty percent of eaters surveyed are worried that the food they consume may well be poisoned. That's not a surprise, given the terrible foodsafetyscape that President Obama inherited. But it's not just an inheritance problem anymore: The Obama administration is being rocked with the same kinds of recalls that have plagued every other presidential administration. In the last two months, there's been more than 300,000 pounds of ground beef recalled, the Nestle Toll House cookie dough recall is scaring the heck out of cookie lovers everywhere, and now comes even worse news that points to how ineffective FDA still is at managing recalls of contaminated food. The salmonella-tainted pistachio nuts that were recalled for contamination two months ago were not destroyed--they were simply repackaged, and are now back in the food chain. That's harrowing, and yet to be expected...because FDA has no firm recall powers, cannot enact criminal sanctions, and is still overburdened and underfunded.

The President's new Food Safety Working Group is a swell idea, but the gang needs to be meeting on a weekly basis. To date, there have been two meetings, one glossy website, and no visible action. Membership in the group has also been kept a tightly guarded secret; Ag Secretary Vilsack is on board, as is HHS Secretary Kathleen Sebelius, and Drs. Hamburg and Sharfstein of FDA...but who else is giving advice? And what does that advice entail? Worried eaters everywhere want to know: 83 percent of the respondents to the IBM survey could identify, by name, a food product that was recalled in the past two years due to contamination. 63 percent confirmed they would not buy the food until the source of contamination had been found and addressed (adios, Nestle profits, because no one has any idea how E Coli got into the cookie dough; E coli is usually a pathogen associated with cow dung). 49 percent of the respondents also said that they'd be unlikely to purchase a food product again if it was recalled due to contamination. Food safety is not only a public health issue, it's also a huge economic issue, at a time when the country can ill afford any more debilitating economic crises.

As food safety issues continue to plague the American food chain, the USDA remains devoid of an under secretary to head its own division, the Food Safety and Inspection Service (FSIS), which monitors all of the nation's meat, poultry and eggs. Agriculture Secretary Tom Vilsack has cited conflict of interest issues with vetted candidates as the key reason FSIS remains unguided, but now there's a new campaign brewing, from Food Democracy Now! and other food activist groups, to encourage the Secretary to finally name pre-eminent food poisoning attorney Bill Marler as his meat man.

Ob Fo has long been an advocate of Mr. Marler, who is a world renowned food safety specialist, thanks to a long career as both a safety activist and the most successful prosecutor of food poisoners in the history of the US. Mr. Marler has gone through the entire administration vetting process for FSIS under secretary, including visits from the FBI, and trips to Washington. Happily, he's also paid his taxes, and he's never been registered as a lobbyist for food and Ag issues...so no worries there.

Secretary Vilsack has shown himself to be quite visionary in the last six months, as he's taken on the herculean task of reforming and managing the USDA, which has an almost unbelievably huge mandate. He's made all kinds of terrific appointments, and surrounded himself with experienced professionals who will help bring the USDA into the 21st century. Bill Marler would be just this kind of visionary appointment to lead FSIS. And the timing couldn't be better, because it's BBQ season after all, and the hamburgers are going to be hitting the grill in record numbers...as meat recalls continue to flood the marketplace.

Marler Clark Calls for JBS Swift and FSIS to Reveal Retail Distribution of E. coli-Tainted Beef
Contaminated Meat Has Sickened at Least 18 to 24 People
Source of Article: http://www.foodpoisonjournal.com/
Posted on June 28, 2009 by Bill Marler

In the early morning hours of Sunday, June 28, the JBS Swift Beef Company expanded the earlier recall of 41,280 pounds of beef contaminated with the highly toxic pathogen E. coli O157:H7 to include an additional 380,000 pounds. The beef recalls are FSIS Class I, meaning the ¡°use of the product will cause serious, adverse health consequences or death.¡± The company and The Food Safety and Inspection Service (FSIS) have made available a list of recalled products, but so far have refused to reveal where those products were shipped, even in light of illnesses linked to the meat.

¡°The FSIS has indicated that 24 illnesses are being investigated in connection with the recall, and 18 have been linked,¡± said food safety advocate and attorney William Marler. ¡°Yet consumers have no information as to what states or countries the tainted meat was shipped to or what retail outlets or restaurants received it. JBS Swift has this information at its fingertips, FSIS should have access to it as well, and it is unconscionable that they have not made it available to the public.¡±


¡°The JBS Swift recall is the seventh so far in 2009. FSIS policy of identifying retailers that received recalled products within 3-10 days appears to be getting a hit-or-miss application. At times, retailers were identified on the same day as a recall, and on others, not at all,¡± added Marler.


¡°We know where we shop,¡± continued Marler. ¡°If we are told that the supermarket where we buy our food received beef that has been recalled due to contamination with a pathogen that could severely sicken our family, we¡¯re going right to the refrigerator to see if we have any of the product. On the other hand, if we hear that some beef has been recalled, and maybe see a list of numbers and codes, most of us are going to assume that the recall doesn¡¯t apply to us. Because if it did, certainly we would be alerted by the government agency responsible for our health. We entrust our family¡¯s lives to the FSIS and to the companies it regulates. They must step forward with the information that consumers need, and they must do it now.¡±


After years of large recalls, focused efforts by meat regulators brought down E. coli contamination recalls to a low of 182,000 pounds in 2006. Recalls shot up again in 2007, and in the ensuing years (2007-2009), over 42 million pounds of beef have been recalled due to contamination with E. coli O157:H7.