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Newsletter #3
6/30/2009
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5%, ´ëÀå±Õ °ú´Ù°ËÃâ
source : http://www.todaykorea.co.kr
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source : http://newswire.ytn.co.kr
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source : http://news.kukinews.com
ÀÛ¼ºÀÚ : Á¶±ÔºÀ ±âÀÚ ckb@kmib.co.kr
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.
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