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Nestle
Unit Denied FDA Requests By JANE ZHANG 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. 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.
Nestle
Plant Refused Full Cooperation with FDA 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. William Marler Opinion - Who Poisoned Our Cookies With E. coli? Source of Article: http://www.foodpoisonjournal.com/ What if the cookie dough
E. coli outbreak actually happened this way? 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. - Biological and chemical
agents 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
¡®Guess Who Inspects It Game¡±: Nestle E. coli Cookie Dough Edition 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. 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 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
The House of Representatives
plans to consider the Food Safety Enhancement Act of 2009 after July
4. Food Safety Still Getting a ¡®D¡± in Obama Era, Despite Early Moves to Enter 21st Century Source of Article: http://www.foodpoisonjournal.com/ 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 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.
Animal
fats linked to pancreatic cancer: Study The authors used data collected
by the National Institutes of Health-AARP Health Study to analyze the
diets of 500,000 people who had completed food frequency questionnaires
in 1995 and 1996. Participants were then followed for an average of
six years to track a number of health issues, including pancreatic cancer.
Of those sampled, 1,337 were diagnosed with the cancer ? 865 men and
472 women. Source: Journal of the National Cancer Institute ¡°Where¡¯s The
(Recalled) Beef? Massive Expansion of JBS Beef Linked to Multi-State
E. coli O157:H7 Outbreak and Still No List of Retailers From FSIS At least when Nestle USA
announced that it was recalling all its Toll House cookie products,
the public pretty much knew which retailers were involved. Every retail
grocery in the country provides generous space for Nestle products. Toxic chemical
in plastic pallets could be leaching into food, says group Significant levels EWG senior vice president for communications Richard Wiles warned FDA commissioner Dr Margaret Hamburg in a letter this week that significant levels of Deca could build up during the standard food industry practice of ¡°hydro-cooling¡± when stacked pallets filled with fruit and vegetables are submerged or when water is dripped over them. Because the water is recycled repeatedly during this process, the concentration of Deca increases and opens the possibility for leaving a residue of the chemical on food, said the EWG. It said preliminary studies strongly suggested that Deca leached from the pallets during this procedure. ¡°Based on an EWG review of
publicly available information it appears likely that Deca treated pallets
are being used in ways that could contaminate food with Deca without
the necessary pre-market approval,¡± wrote Wiles. Call for action Looking at Leftovers - Lack of Contaminated Product is Not an Alibi Source of Article: http://www.foodpoisonjournal.com/ We are in the midst of another sprouts recall. Sprouts from Kowalke Organics from Culver City, California are being pulled from shelves over potential contamination with Salmonella. According to the LA Times: "Mike Matthews, Kowalke¡¯s owner, told the Associated Press that only one package -- with the sell-by date of June 21 -- tested positive for salmonella, so far." There is not yet confirmation of illness associated with this latest recall. Still, Mr. Matthews comment brings up again how misleading statements like this can be. A perfect example is last summer's E. coli O157:H7 outbreak traced to lettuce. Health officials gathered overwhelming epidemiological evidence to implicate the product. The producer, though, kept crowing to the press about how none of the lettuce tested from its plant tested positive. Of course, health officials were forced to point out that the product tested was CURRENT PRODUCT, i.e. the product in the plant at the time the outbreak was recognized. Thank goodness there wasn't STILL contaminated product on hand. The product actually implicated in the outbreak was long gone, and could not be tested. In outbreaks involving perishable items, such as produce, finding product produced and packaged at a time that coincides with product implicated in an outbreak is very unusual. Think about this very plausible, but hypothetical, time line. Produce goes out, lets say lettuce, processed on July 1. It hits the shelves on July 5. On July 7 its purchased, and then consumed two days later on July 9. The incubation period for E. coli O157:H7 generally runs 2 days to a week. So let's say the consumer has onset of symptoms on July 12. By July 14, the consumer is sick enough to go to the doctor. If we are lucky, a stool culture is ordered the first day of medical care. Results return 48 hours later, and now it is July 16. A good health department is notified of the illness, and interviews the consumer for a food history immediately. It's now July 17. Before health officials are testing product, there usually need to be multiple illnesses that suggest a product as a culprit. Even assuming the best time line, it is probably nearly three weeks from processing to the opportunity to test product. By then, product processed on July 1 has been consumed or discarded. So, the next time you hear
a produce supplier tell you that "none of our product has tested
positive," bear this in mind. Such proclamations are essentially
worthless at best, and more likely misleading. Main
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