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E. coli Lawyer Is Busier Than Ever
By PAUL ELIAS 4 hours ago
Source of Article:
SAN FRANCISCO (AP) ? A girl fell into a 40-day coma after eating a bad Jack in the Box hamburger. Fifteen years later, she is still suffering ill effects. That doesn't bode well for a toddler who spent six weeks in the hospital in 2006 after eating E. coli-tainted spinach from California.
But both have lawyer William Marler in their corner and that's no small consolation.
The Seattle-based Marler is the undisputed king of food poisoning litigation. He has made good money from bad food, ringing up more than $300 million in settlements for his clients in the rapidly growing legal field of food safety.
"There is a sense of complacency in the meat industry that believes, `Hey, we solved that problem and we don't have to watch it so much,'" says Marler, whose career has proved otherwise.
The Centers for Disease Control and Prevention estimates that food poisoning each year afflicts some 76 million Americans; 300,000 require hospitalization and 5,000 die.
Many victims end up hiring Marler, who took his first food poisoning case in 1993, during the Jack in the Box E. coli outbreak in the Pacific Northwest that sickened hundreds and killed four children.
"Bill was certainly at the right place at the right time entering the field of food safety litigation," says Caroline Smith DeWaal, who is in charge of food safety at the nonprofit Center for Science in the Public Interest in Washington. "I see him in kind of a private attorney general role."
Marler, 50, operates three dozen Web sites dedicated to food-borne illnesses. He is a tireless blogger on all things food safety and appears in front of federal and state lawmakers and regulatory boards. The license plate on his wife's Volkswagen reads ECOLI.
In all these cases, Marler has gone to trial just once, winning a $4.6 million verdict against a Washington state school district where 11 children got E. coli poisoning in the cafeteria.
Instead, he adroitly uses his sympathetic clients and the media ? to shame food producers into settling.
"I don't apologize for that," he says. "The publicity helps generate change."
The past year has been a busy one for Marler's six-lawyer firm, which has about 1,000 active cases in all 50 states. The clients typically pay their lawyers 25 to 35 percent of their settlements.
The targets of Marler's lawsuits include the Topps Meat Co., which recalled 21.7 million pounds of its hamburger patties in September ? the second-biggest U.S. beef recall ever ? then went out of business. When Cargill Inc. recalled 840,000 pounds of beef patties the following month, it brought more lawsuits by Marler.
He is also suing ConaAgra Foods Inc., which recalled its Banquet chicken pot pies and Peter Pan peanut butter last year after they were found to be contaminated with salmonella.
"He's a good lawyer and he does a fine job for his clients," says Leo Knowles, ConAgra's top lawyer. "He's passionate about food safety. At times he's a little bit overly dramatic, but I think he's genuine."
Marler continually implores the food industry to "put me out of business" by adopting more stringent safety procedures. He sent the lettuce industry a letter in 2006 in which he called on growers to stop using irrigation water contaminated with cattle and human feces, to wash fruits and vegetables more thoroughly, and to provide field hands with bathrooms.
"These steps will help make our food supply safer and will enable us to keep our most vulnerable citizens ? kids and seniors ? out of harm's way," he wrote. "And, with a little luck, it will force one damn trial lawyer to find another line of work."
Marler holds degrees from Washington State University and the Seattle University School of Law. He has no formal scientific training but has immersed himself in microbiology and DNA tracing, and his firm has a scientist on staff on whom he relies.
Marler handled about 150 cases from the deadly 2006 E. coli outbreak involving California spinach, settling roughly half those cases so far with companies such as Dole Foods. Among the clients whose cases are still unresolved is 3-year-old Ashley Armstrong of Indianapolis, whose kidneys were so damaged she will have to take medication for the rest of her life and will probably need a transplant, according to her mother.
He also has been settling dozens of cases against Taco Bell stemming from a 2006 E. coli outbreak that sickened 71 people in five states.
Marler fell into food safety litigation almost by accident.
Brianne Kiner, 9, of Seattle was the first among hundreds who fell ill in the Jack in the Box outbreak. Six lawyers trekked to her bedside during the six months she spent in the hospital, hoping to represent the family. The Kiners hired Marler, a young associate at a mid-size law firm who had never worked on a food case.
"I wanted a young, hungry lion," recalls Suzanne Kiner, Brianne's mother. "He was also the only one who looked at her and teared up."
Against all odds, Brianne survived and lives in a house bought with some of the $15.6 million Marler extracted from the restaurant chain for the Kiners. But Brianne, now 25, still suffers from high blood pressure and immune system damage that makes her prone to colds and flu.
"I call him Uncle Bill," the young woman says. "I think it's incredible what he did, and I'm very thankful that he helped me."
Marler says: "When I started doing the Jack in the Box case in 1993, I never dreamed that I would be doing this in 2008. Unfortunately, it never seems to slow down."

Marler Clark Presents New Look for Food Poisoning Informational Web Sites
SEATTLE--(BUSINESS WIRE)--The Marler Clark network of food poisoning informational Web sites, which first appeared online in 1998, recently received a makeover. The sites, which were originally put online to provide Internet users with basic information about the illnesses caused by such foodborne pathogens as E. coli O157:H7, Salmonella, and Hepatitis A, have increased in breadth over the years to include information about complications caused by foodborne pathogens: hemolytic uremic syndrome (HUS), reactive arthritis (Reiter¡¯s Syndrome), and Guillain-Barre syndrome. Those sites are:

¡°We have heard time and again how valuable the information provided on these sites is to parents whose children are in the hospital. When your kid is sick, you arm yourself with as much information as you can, and these sites provide a comprehensive look at these ¡®bugs¡¯ and the illnesses they cause,¡± commented William Marler, managing partner of Marler Clark.
The sites also provide information related to high-profile food poisoning outbreaks that have occurred in the last 15 years. ¡°Since Marler Clark has represented victims of nearly every major foodborne illness outbreak in the last fifteen years, we felt it was important to share the details of these outbreaks with anyone doing research on a particular pathogen,¡± Marler continued.
Marler Clark has represented thousands of victims of foodborne illness outbreaks since the 1993 Jack in the Box E. coli outbreak. The firm has resolved $300 million worth of cases on behalf of food poisoning victims, bringing claims against such food-companies as AFG, BJ¡¯s Wholesale Club, Blimpie¡¯s, the Brook-Lea Country Club, Byerly¡¯s, Cargill, Carl¡¯s Jr., Carneco, Carrabba¡¯s Italian Grill, Chi-Chi¡¯s, Chili¡¯s, China Buffet, ConAgra, Cub Foods, Dole, Emmpak, Excel, Filiberto¡¯s, Finley School District, Friendly¡¯s, Gate Gourmet, Gold Coast Produce, Golden Corral, Habanero¡¯s, Harmony Farms, KFC, King Garden Restaurant, Lund¡¯s, Malt-O-Meal, McDonalds, Natalie¡¯s Orchid Island Juice Co., Natural Selections Foods, Odwalla, Olive Garden, Paramount Farms, Pat & Oscar¡¯s, PM Beef Holdings, Quality Inn, Quizno¡¯s, Regent Beverly Wilshire Hotel, Robert¡¯s American Gourmet (Veggie Booty), Sam¡¯s Club, San Antonio Taco, Senor Felix, Sheetz, Silver Grill Location Catering, Sizzler, Sodexho, Souplantation, Spokane Produce, Subway, Sun Orchard Juice Co., Supervalu, Sushi King, Susie Cantaloupe, Taco Bell, Taco John¡¯s, Topps, United Food Group (UFG), Viva Cantaloupe, Wal-Mart, and Wendy¡¯s.

Marler Clark LLP, PS
Suzanne Schreck, 206-346-1879

Grocery Manufacturers Association Reaction to President Bush¡¯s 2009 FDA Food Safety Budget Proposal
Source of Article:
Scott Openshaw, Director, Communications, 202-295-3957
Brian Kennedy, Manager, Communications, 202-639-5994
February 4, 2008
WASHINGTON, D.C. - The Grocery Manufacturers Association (GMA) issued the following statement by Cal Dooley, GMA president and CEO, in response to President Bush¡¯s 2009 FDA food safety budget proposal:
¡°The food industry has made significant new investments in food safety to meet the challenges of today¡¯s evolving global market and we are doing our part to ensure consumers have full confidence in the safety of the foods they buy. Now, Congress must make a commensurate investment in FDA's food-related programs so that the FDA has the resources it needs to fulfill its critical food safety mission.
¡°The President's proposal to increase FDA food-related spending by $32 million does little more than cover the cost of inflation and falls short of what is ultimately needed to make certain FDA has the tools it needs to get the job done. However, we are confident that Congress will provide the necessary resources to rebuild FDA's scientific capacity.
¡°America enjoys the world's safest food supply, but rising imports and changing consumer preferences pose new challenges for the food industry and for the FDA. Like national defense, highways and bridges, food safety is a benefit every American has a right to expect. We urge the Administration and Congress to increase FDA funding from general revenue and reject any new food taxes - especially at a time of economic uncertainty.¡±
The Grocery Manufacturers Association (GMA) represents the world¡¯s leading food, beverage and consumer products companies. The Association promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence. The GMA board of directors is comprised of chief executive officers from the Association¡¯s member companies. The $2.1 trillion food, beverage and consumer packaged goods industry employs 14 million workers, and contributes over $1 trillion in added value to the nation¡¯s economy. For more information, visit the GMA Web site at

Wal-Mart Becomes First Nationwide U.S. Grocer to Adopt Global Food Safety Initiative Standards
Nation's largest grocery chain requires suppliers of private label and select food products to comply with standards above FDA or USDA requirements by end of 2008
February 04, 2008:
Source of Article:
BENTONVILLE, Ark., Feb. 4 /PRNewswire-FirstCall/ -- Wal-Mart Stores, Inc. has become the first nationwide U.S. grocery chain to require suppliers of its private label and other food products such as produce, meat, fish, poultry and ready-to-eat foods to have their factories certified against one of the internationally recognized Global Food Safety Initiative (GFSI) standards.
A group of major international retailers committed to strengthening consumer confidence in the food they purchase, the GFSI now lists Wal-Mart among the companies who have agreed to improve food safety through a higher and consistent auditing standard.
Selected by CIES (, the Food Business Forum, to safeguard and ensure high quality in the international food supply chain, GFSI standards provide real time details on where suppliers fall short in food safety on a plant-by-plant basis, and go beyond the current FDA or USDA required audit process. Under the GFSI program, producers of Wal-Mart and Sam's Club private label and other foods sold in the U.S. must be audited by independently trained, approved and licensed auditors who are experts in their industry.
"The requirement for suppliers to complete these certifications demonstrates our leadership in food safety and our commitment to global safety standards," said J.P. Suarez, Wal-Mart's senior vice president and chief compliance officer, and a board member of the Global Food Safety Initiative. "Food safety has always been a top priority at Wal-Mart. We are taking this additional step to ensure the integrity of our products throughout the entire food supply chain. We encourage other U.S. retailers to follow our lead and to also endorse these standards."
The GFSI requires food suppliers to achieve factory audit certification against one of its recognized standards, which include Safe Quality Food (SQF), British Retail Consortium (BRC), International Food Standard (IFS), or an equivalent such as Global-GAP. Wal-Mart has published a schedule to suppliers requiring completion of initial certification between July and December of 2008, with full certification required by July 2009. Audits will be completed by approved third party auditing companies.
Wal-Mart private label food brands in the U.S. are Great Value and Sam's Choice. Sam's Club private label food brands in the U.S. include Member's Mark and Bakers & Chefs.
"Our customers expect high quality at every day low prices when they purchase any of our private label foods, and we're committed to meeting -- and exceeding -- their expectations," said Andrea Thomas, Wal-Mart's senior vice president, private brands. "The GFSI standards are an added step that will help us -- and our U.S. food producers -- keep our quality commitment."
Internationally, Wal-Mart stores in the United Kingdom (ASDA) and Japan (Seiyu) also require suppliers of food products to comply with GFSI standards.
The Global Food Safety Initiative was launched in May 2000 to establish food safety management systems to ensure confidence in the delivery of safe food to consumers. The initiative has fostered a convergence among food safety standards, achieved cost efficiencies through common acceptance of GFSI recognized standards, and provided a forum for exchange of best food safety practices.

About Wal-Mart Stores, Inc.
Wal-Mart Stores, Inc. operates Wal-Mart discount stores, Supercenters, Neighborhood Markets and Sam's Club locations in the United States. The Company operates in Argentina, Brazil, Canada, China, Costa Rica, El Salvador, Guatemala, Honduras, Japan, Mexico, Nicaragua, Puerto Rico and the United Kingdom. Wal-Mart serves more than 176 million customers weekly in 14 markets. The Company's securities are listed on the New York Stock Exchange under the symbol WMT. For more information:

Food Safety and Quality Related Job Openings
NIR/Analytical Services Manager ? Land O¡¯Lakes, Inc. - Shoreview, MN
Sanitation Manager ? Malt-O-Meal - Northfield, MN
Food Safety Consultant - Agricultural Consulting Services, Inc. ? Rochester, NY
Quality Control Supervisor - Channel Fish Co. ? Boston, MA
Food Safety Programs Director ? Food Marketing Institute - Crystal City, VA
Food Chemist/ Nutritional Chemist ? EMSL Analytical, Inc. - Indianapolis, IN
QA/QC Manager - Carl Buddig and Company ? South Holland, IL

Food Safety and Quality Related Job Openings

iPura(R) Hardware Unveiled as the Greatest Advancement in Seafood Safety - Since Ice
Posted : Mon, 04 Feb 2008 16:15:37 GMT
Author : Global Food Technologies, Inc.
Source of Article:
HANFORD, CA -- 02/04/08 -- Global Food Technologies, Inc. ("GFT"), a California-based life sciences company focused on food safety, unveiled its first commercial food safety system at its science and engineering facility to an audience of stakeholders in the food distribution chain.
"Today marks the unveiling of our food safety hardware that will be the centerpiece of the iPura food safety strategy. The iPura Food Safety and Quality Assurance Service includes a comprehensive daily regimen integrating proprietary organic technologies and extraordinary precautions to combat foodborne hazards. Our globally patented technologies are focused on the elimination of food poisoning due to the ingestion of E.coli, Salmonella, Listeria, Campylobacter, Vibrio and other deadly hazards which too frequently contaminate food products during the farming, processing, packaging and distribution stages. Our turn-key systems such as the one we unveiled today will be integrated into food processing facilities and operate in a cleanroom environment," stated Keith Meeks, President of GFT.
Eduardo Kipreos, CEO of Primar in Puerto Montt, Chile, a leading salmon processing company stated, "Primar is honored to be the first licensee and joint venture partner with iPura. The salmon industry in Chile is important to the economy of our country and iPura could give us a competitive advantage for years to come." Echoing those sentiments, Pedro Bravo Deputy Trade Commissioner for ProChile, the Chilean Trade Commission commented, "This is the next step for our salmon industry which will allow us to provide the world's safest seafood products and maintain Chile's market edge in a very competitive industry."
Today's consumers expect a greater degree of food safety and most believe that not enough is being done to protect their health. The U.S. Center for Disease Control estimates that one in four Americans contracts food poisoning, resulting in 5,000 deaths and 325,000 hospitalizations each year in the U.S.
Aaron Ormond, Director of Science for GFT, discussed the science on which iPura is founded, "We have developed a hurdle technology, a combination of scientific interventions to achieve superior efficacy by combining pressure, temperature, vacuum, UV disinfected water and an environmentally friendly organic antimicrobial solution targeted at the elimination of disease causing pathogens and other spoilage organisms in food products. The calculated combination of these processes yields a lethal effect to the pathogens, is harmless to consumers, with no changes to the organoleptics or nutritional value of the product."
"The iPura¢ç seal communicates to consumers that extraordinary science-based controls have been taken to ensure the integrity of their food. iPura adds value to the distribution chain by satisfying consumer demand for natural, healthy, clean, safe and sustainable food. Processors, importers, distributors, food service and grocers can reduce spoilage and liabilities, increase sales and profit margins while protecting their brand image and safeguarding public health," concluded Robert Clark, GFT Director of Marketing.
Curtis Keyes, CEO of International Cargo Loss Prevention, stated, "The need for GFT's solutions has never been greater than it is today. Whether you are a consumer, a regulator, processor or importer, you will surely find valuable benefits for supporting iPura in the market place."
Ron Christie, VP of DC Navigators, a Washington D.C.-based lobby group agreed, "iPura's science-based prevention model will ensure that safety is integrated into products before they reach consumers. The daily on-site service, multiple interventions and verification methods of iPura result in the highest standard in food safety."
Information on GFT is available at: and
Investor Relations Contact:
Michael Shaw
(559) 589-0100
Email Contact

Mad Cow Disease: Should the USDA Do More?
Source of Article:
Current testing methods may not provide sufficient protection from mad cow disease, or bovine spongiform encephalopathy.
Since 1996, strong evidence has accumulated linking outbreaks of mad cow disease to a fatal neurological disease in humans called variant Creutzfeldt-Jakob disease (vCJD), according to the Centers for Disease Control and Prevention. In cattle herds, the disease seems to appear when ¡°meat byproducts¡± (beef tallow, bone meal and other cheap protein sources) are added to a herd¡¯s feed. The evidence shows humans can contract the disease when they eat infected beef.
But the debate among federal regulators, meat processors, ranchers and consumer advocacy groups about how best to contain the threat of mad cow disease, or bovine spongiform encephalopathy (BSE), continues to evolve.
In December 2003, inspectors in Washington state discovered the first domestic case of mad cow disease (the animal was later determined to be from Canada). Within days, 53 countries worldwide shut their doors to U.S. beef. A study by the Kansas Department of Agriculture places national beef industry losses at $3.2 to $4.7 billion for 2004 alone.
Yet when Creekstone Farms Premium Beef, a processor in Kansas, attempted to implement a 100 percent testing policy to screen cattle for mad cow disease in its facility, the USDA ordered it to stop. The USDA contends that such testing may provide a false sense of security because most cattle are too young to show symptoms at the time of slaughter. Critics argue that the USDA is opposing more testing because if more infected cattle are found, it will again cause huge losses for the beef industry.
Feeding beef byproducts to cattle was implicated in Great Britain¡¯s mad cow outbreak in the 1980s and ¡¯90s, but the United States didn¡¯t ban this practice until 1997. Canada instituted a similar ban the same year, but has discovered 11 cases since, one as recently as last May.
Global efforts to stop the spread of mad cow continue, but they¡¯re complicated by the fact that scientists still have a lot to learn about the disease. A 2004 survey by the Consumers Union found that 88 percent of Americans think all beef entering the food supply should be tested, but the USDA maintains that its small sampling program is sufficient.
In recent months, a number of countries have lifted their embargoes on U.S. beef imports, but regaining consumer confidence may take more time.

Salmonella monitoring now a legal requirement for laying flocks
News | 4 February, 2008
Source of Article:
By Alistair Driver
NEW legislation has come into force making it a legal requirement for keepers of laying flocks to take steps to assess levels of salmonella in their flocks.
Farmers are required to follow a sampling and testing programme set out in a National Control Programme (NCP) to establish the prevalence of salmonella on-farm
The programme targets two most important types of salmonella for human health, salmonella enteritidis (SE) and salmonella typhimurium (ST). It aims to reduce incidence in each by 10 per cent per year for the next three years from a baseline established following an EU-wide survey in 2006.
In this survey, UK levels of SE and ST were found to be among the lowest of the major egg producing member states, with one or the other present on 8 per cent of laying flock holdings. This compares with an average across all member states of 20.4 per cent.
The NCP requires that from 2009, eggs from flocks confirmed to be infected with SE or ST cannot appear as fresh shell eggs at retail. Such eggs may not be used for human consumption unless treated to eliminate salmonella.
New legislation to support the NCP in laying flocks came into force on Friday (February 1).
Deputy chief veterinary officer, Alick Simmons, said: ¡°The UK egg laying industry has worked hard, including through voluntary measures, to control salmonella as demonstrated by the low levels reported following the EU survey.
"However, we believe that with the support of industry the National Control Programme can further enhance the reputation, quality and safety of UK egg production.
¡°I would encourage producers to seek expert advice from their vet or Animal Health or the Veterinary Laboratories Agency as to how to meet the control measures, and as always to monitor their flocks and take action to reduce the risk of infection.¡±
By February 2008 all Member States are expected to have implemented a National Control Programme which meets the requirements of EU legislation.
Guidance on the requirements of the NCP is included in a revised Code of Practice for the Prevention and Control of Salmonella in Commercial laying flocks.
This can be downloaded from:

Minnesota Department of Health and CDC Pins Name on Pig Slaughterhouse Illness - Progressive Inflammatory Neuropathy
Posted on February 1, 2008 by Food Poisoning Attorney
Source of Article:
Lauran Neergaard of the AP again breaks another disturbing story about the dangers of our food supply. She reports this evening that Investigators are preparing to test pig brains as they struggle to tell what is causing a mysterious nerve illness affecting pork plant workers in Minnesota and Indiana. The CDC and Minnesota Department of Health are calling the condition "progressive inflammatory neuropathy" - meaning something is triggering inflammation serious enough to damage nerves. All 14 employees who became ill worked near powerful compressed air systems that blow brains out of pig heads at what is known as the head table. Both plants have stopped using the process.

Cruise industry efforts pay off with sharp decline in stomach virus
By Tom Stieghorst | South Florida Sun-Sentinel
February 5, 2008
Source of Article:
Cruise passengers got a break last year, as serious cases of gastrointestinal illness at sea fell sharply after setting a record in 2006.
But cruise industry officials are watching an upswing in norovirus cases in the United Kingdom to see whether it will become a problem worldwide.
Federal ship regulators say cruise lines have become the model for fighting outbreaks of norovirus, which spreads easily and causes flu-like symptoms for 48 to 72 hours.
"They're much better at it today than they were in 2002," said Capt. Jaret Ames, head of the vessel sanitation program at the U.S. Centers for Disease Control in Atlanta.
Unlike nursing homes and hotels, cruise ships are required by law to disclose gastrointestinal illness regardless of cause. Norovirus is now a bigger cause of illness at sea than bacteria such as e-coli or salmonella.
Last year, there were 16 confirmed outbreaks of norovirus on ships monitored by the CDC, down from 29 outbreaks the year before.
Overall, a small fraction of passengers are affected, according to cruise lines. Last year, 12.6 million people took a cruise worldwide. The cruise Web site calculates that at least 4,159 passengers fell ill with norovirus. A CDC spokeswoman said the agency doesn't keep a running total of passengers ill with norovirus. So far in 2008, the CDC has reported outbreaks on five ships sailing in North American waters, the latest being Carnival Cruise Lines' Holiday, on a cruise from New Orleans. Tests to confirm norovirus are pending.
Ames said the reason outbreaks fell in 2007 isn't clear, but he noted that in 2006 a new norovirus strain, called Minerva, emerged. "Usually when there is a change like that, we have a lot of outbreaks associated with that new strain."
In 2002 when the Farmington Hills strain emerged, cruise ship outbreaks more than quadrupled to 13. Ames said regulators are looking to see whether a new variant is emerging this year in England.
Public health authorities there closed 57 hospital wards in early January in a bid to slow the spread of norovirus cases occurring at a rate of 100,000 a week, according to the Royal College of General Practitioners. The U.K.'s Health Protection Agency said it was the highest number of cases reported in early winter since 2002.
Cunard Line's Queen Victoria reported an outbreak of norovirus affecting 171 passengers on its 16-night holiday cruise from Southampton, England, in December.
Terry Dale, president of the cruise industry's Fort Lauderdale-based trade association, said high levels of norovirus make it more important for passengers to practice a healthy hand-washing routine.
Norovirus affects vacations on land as well. The Hilton Beach Resort at Singer Island closed its kitchen last month for several days after an outbreak affected 87 people, said Tim O'Connor, Palm Beach County Health Department spokesman. On land, norovirus need not be reported to health authorities. At sea, any gastrointestinal illness that affects more than 3 percent of a ship calling at a U.S. port must be reported.
The CDC's Ames said the cruise industry has made progress since 2002, especially in stopping transmission of norovirus on successive cruises. Last year that occurred on only one ship, Holland America Line's Ryndam, which had outbreaks on three consecutive voyages from January to March, compared with two cases industrywide in 2006.
Ames credits cruise managers for sending extra medical and cleaning crews to ships with severe outbreaks, and for better informing arriving passengers about outbreaks and keeping them segregated from departing passengers.
"The cruise lines have worked hard on this," he said.

Proposed Budget Increase for FDA
Aimed at Boosting Safety Measures
February 4, 2008 5:41 p.m.
Source of Article:
WASHINGTON -- The White House's 2009 budget request for the Food and Drug Administration would focus the bulk of the proposed $130 million budget increase on food-safety initiatives and on monitoring the safety of drugs and medical devices already on the market.
The overall FDA request seeks $2.4 billion in fiscal year 2009, which the agency said is an increase of 5.7% over the current fiscal year's budget. The request includes $1.7 billion from Congress and $628 million in user fees collected from drug and medical-device companies. Such fees are charged, for example, when companies submit applications for the agency to review new brand-name drug and medical devices. The 2009 fiscal year starts Oct. 1.
While the Bush administration is seeking an increase for the FDA in the face of an overall cut to the agency's parent, the Department of Health and Human Services, consumer and industry trade groups said the increase wasn't nearly enough to ensure the safety of the nation's food, drugs and medical devices. Last week, some members of an outside panel of medical experts that advises the FDA on science matters called for a doubling of the agency's budget over the next two years in order to put the agency in a position to properly regulate the products it oversees.
John Dyer, FDA's chief operating officer, defended the size of the budget increase, saying it "lays the groundwork for where we need to go" in a tight budget environment.
Specifically, the budget request seeks an increase of $42.2 million for the agency's food-safety protection plan and is largely aimed at trying to prevent food-borne illnesses before they occur. The agency hopes to open offices in China and other overseas locations to better oversee the production of food imported into the U.S.
The budget also seeks a $17.4 million increase for programs aimed at monitoring the safety of medical products. Congress approved $25 million in funds for the current fiscal year for drug-safety initiatives. Dyer said there is an additional $10 million for such programs included in the 2009 budget request.
The White House also said it would seek authority for the FDA to approve generic versions of expensive so-called biologic drugs, a move that could boost the chances of legislation being approved this year giving the FDA that authority. The Senate approved biotech language as part of broader FDA legislation last year, but it was dropped out of a compromise deal with the House.
A 1984 U.S. law that created a pathway for the FDA to approve generic drugs left out almost all biotech products. Now biotech drugs, which are made from living cells, represent some of the most expensive and important medications, and some of their earliest patents are beginning to expire.
The FDA budget proposal also seeks congressional approval to establish a user-fee program for generic drug makers to help the agency deal with an increasing number of generic drug applications and a fee for the agency to review direct-to-consumer television drug advertisements. Both proposals were in the request for the 2008 budget but failed to become law.

Mass food poisoning raises query over Chinese Olympics catering
Justin McCurry in Tokyo
Friday February 1, 2008
The Guardian
Source of Article:,,2250390,00.html
Safety standards in China's food industry were called into question again today with reports that dozens of people in Japan had become ill after eating imported dumplings containing insecticide.
About 80 people are reported to have fallen ill over the past two days after eating the frozen dumplings, made by Tianyang Food Processing in Hebei province. They include a five-year-old girl who fell into a coma, but later regained consciousness.
Tests by the Japanese health ministry revealed that the dumplings contained traces of an organic phosphorous insecticide that can cause severe stomach pains, vomiting and diarrhoea.
Officials in Tokyo cast doubt on China's commitment to food safety, just months before hundreds of thousands of foreign visitors are expected to arrive in Beijing for the Olympics.
"I'm afraid there was a rather loose safety awareness on the Chinese side," Nobutaka Machimura, Japan's top government spokesman, said.
Chinese authorities said Tianyang Food had been ordered to halt production and recall all of its exports, most of which go to Japan. The country's foreign ministry said preliminary tests conducted on two batches of dumplings made at the factory had found no traces of harmful chemicals, but promised a full investigation.
Schools and restaurants in Japan removed Chinese-made food from their menus and TV stations warned viewers not to eat any food imported from China.
The outbreak casts doubt on China's claims to have raised food safety standards after a four-month campaign prompted by the discovery of hazardous substances in children's toys, toothpaste, pet food and other exported items.

Cadbury adopts new pathogen testing system
By Charlotte Eyre
Source of Article:
04/02/2008 - Global confectionery giant Cadbury has stepped up its microbiological surveillance by adopting the Pathatrix pathogen testing system, according to its creator.
Cadbury has adopted a raft of new technologies to test for potentially harmful food-borne bacteria over the past year, after salmonella contamination forced the company to carry out a ¡Ì50m chocolate bar recall in 2006.
According to Matrix Microscience, the company that designed the technology, Cadbury chose Pathatrix because it allows food manufacturers to increase the number of food samples tested for pathogens in a shorter amount of time.
"The Pathatrix system provides Cadbury with a validated, science-based solution to the rigorous demands of a highly interdependent and time-critical supply chain," said Jeff Banks, group director of food safety & quality for Cadbury Schweppes, in a statement. "The system integrates well with other technologies and provides a high quality and practical asset for our laboratories."
The microbial detection system comprises a Pathatrix workstation and a 'consumable', or tube system.
Once set up, a food sample is then pumped around the tubes for a period of thirty minutes. During this time small magnetic particles, coated with antibodies specific to a target pathogen, pick up on the presence of any pathogens that may be present in the product.
Adrian Parton, chief executive of Matrix Microscience, told that Cadbury chose the Pathatrix system because, unlike other competitors on the market, it allows manufacturers to test large samples of a food product at any one time.
The company also claims that the system is fast and efficient, adding that manufacturers can use a 'pooling' system to test five sub-samples for pathogens at any one time.
If the overall sample tests positive for a harmful bacteria, the original samples can then be re-tested to determine the culprit, but if the initial results are negative no further analysis is required, Parton explained.
Overall results can be obtained within 5 to 21 hours, the company claims.
Cadbury's new safety drive was initiated after the company released salmonella-contaminated chocolate onto the UK market last year, later pleading guilty to breaking nine of the country's food safety laws.
Critically, the company had failed to follow EU-wide hygiene rules, known as Hazard Analysis and Critical Control Point (HACCP) analysis, the principles of which rest on establishing control systems that focus on prevention rather than end-product testing.
In July last year, the company said it spent ¡Ì20m in changing production and testing processes, to ensure that similar outbreaks do not occur in the future.
However, Cadbury spokesperson Tony Billsborough said that the implementation of Pathatrix was unrelated to the salmonella outbreak.
"We have a process of continued improvement here at Cadbury, and this new system is just part of that," he said.
Billsborough also refused to discuss other ranges of testing methods employed by the company for 'confidentiality reasons.'
According to Parton, Cadbury has already established Phatrix at all of its UK sites, as well as some in Europe, and plans to roll the testing system out to its international operations in the near future.
Several other leading chocolate manufacturers are also interested in the technology, he added.

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