WASHINGTON (AP) — Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.

“Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional,” the FDA said in a statement.

Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

Company leaders did not immediately respond to calls for comment Friday afternoon.

Friday’s action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.

Copyright 2009 The Associated Press.

GARANCE BURKE
Associated Press Writer

TERRA BELLA, Calif. (AP) — The salmonella scare that prompted a blanket federal warning against eating pistachios may have erupted because contaminated raw nuts got mixed with roasted nuts during processing, the company at the center of the nationwide recall said Tuesday.

Lee Cohen, the production manager for Setton International Foods Inc., said the company does not believe pistachios were contaminated by a human or animal source in its plant. He said the company suspects that roasted pistachios sold to Kraft Foods Inc. may have become mixed at Setton’s plant with raw nuts that could have contained traces of the bacteria.

The pistachios were processed at central California-based Setton Pistachio of Terra Bella Inc., which is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. Cohen is in California to help as the Food and Drug Administration inspects the nation’s second-largest pistachio processor.

Kraft spokeswoman Laurie Guzzinati said her company’s auditors “observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination.”

She said she didn’t know what they saw specifically, but “that’s how the auditors shared the information with us.”

Federal health officials warned people on Monday not to eat any products containing pistachios while they investigate.

The FDA said Setton Pistachio, the nation’s second-largest pistachio processor, was voluntarily recalling more than 2 million pounds of its roasted nuts shipped since last fall. Some of those nuts were shipped to Norway and Mexico, officials said Tuesday.

“We know that the farm in California shipped its products to 36 wholesalers,” said Dr. David Acheson, assistant commissioner for food safety. “But what we don’t know yet is what those wholesalers did with them — whether they were repackaged for consumers, or whether they were sold to manufacturers making ice cream or cookies or candies.”

Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn’t been confirmed, Acheson said. Still, Setton decided to shut down the Terra Bella plant late last week, officials said.

The FDA learned about the problem March 24, when Kraft Foods Inc. notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.

Kraft expanded its recall this Tuesday to include any Planters and Back to Nature products that contain pistachios supplied by Setton Pistachio since Sept. 1.

“Safety is our top priority,” Guzzinati said. “We’re proud of our quality and the procedures we have in place. This is always a place we look for continuous improvement. In this instance when it was brought to our attention we were able to act and respond.”

The recalled nuts are a small fraction of the 55 million pounds of pistachios that the company’s plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.

California is the second-largest producer of pistachios in the world.

The latest recall is not related to the nationwide recall of peanuts.

__

Associated Press reporter Tracie Cone in Fresno contributed to this report.

Copyright 2009 The Associated Press.

GARANCE BURKE
Associated Press Writer

FRESNO, Calif. (AP) — Federal food officials are warning people not to eat any food containing pistachios because of possible contamination by salmonella, in another food scare sure to rattle consumers already upset by the contamination of peanuts with the same bacteria.

The Food and Drug Administration said central California-based Setton Pistachio of Terra Bella Inc., the nation’s second-largest pistachio processor, was voluntarily recalling more than 2 million pounds of its roasted nuts shipped since last fall.

“Our advice to consumers is that they avoid eating pistachio products, and that they hold onto those products,” said Dr. David Acheson, assistant commissioner for food safety. “The number of products that are going to be recalled over the coming days will grow, simply because these pistachio nuts have then been repackaged into consumer-level containers.”

Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn’t been confirmed, Acheson said. Still, the plant decided to shut down late last week, officials said.

The recalled nuts are a small fraction of the 55 million pounds of pistachios that the company’s plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.

California is the second-largest producer of pistachios in the world.

According to the company’s Web site, Setton Pistachio is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. The company sells nuts, dried fruit, edible seeds, chocolate and yogurt-coated candies.

The FDA learned about the problem last Tuesday, when Kraft Foods Inc. notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.

The FDA contacted Setton Pistachio and California health officials shortly afterward, in what Acheson called a “proactive move.”

By Friday, Cincinnati-based grocery operator Kroger Co. recalled one of its lines of bagged pistachios because of possible salmonella contamination, saying the California plant also supplied its nuts. Those nuts were sold in 31 states.

Fabia D’Arienzo, a spokeswoman for Tulare County-based Setton Pistachio, said the company was only recalling certain bulk roasted in-shell and roasted shelled pistachios that were shipped on or after September 1.

Because Setton Pistachio shipped bags of nuts weighing up to 2,000 pounds to 36 wholesalers across the country, it will take weeks to figure out how many products could be affected, said Jeff Farrar, chief of the Food and Drug Branch of the California Department of Public Health.

“It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes,” Farrar said. “The firm is already turning around trucks in transit to bring those back to the facility.”

Salmonella, the most common cause of food-borne illness, causes diarrhea, fever and cramping. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.

Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.

The national peanut salmonella outbreak was blamed on a Georgia company under federal investigation for flouting safety procedures and knowingly shipping contaminated peanuts.

That outbreak is still ongoing. More than 690 people in 46 states have gotten sick. Nearly 3,900 products made with peanut ingredients from Peanut Corp. of America have been recalled.

California public health authorities have taken hundreds of samples at Setton’s processing facility, but lab results have not yet determined whether salmonella was found at the plant, Farrar said. The food companies’ own tests of the contaminated products isolated four different types of salmonella, but none were the same strain as the one found in the peanuts, Acheson said.

___

Associated Press writers Ricardo Alonso-Zaldivar in Washington and Tracie Cone in Fresno contributed to this report.

___

On the Net:

http://www.settonfarms.com

http://www.fda.gov

Copyright 2009 The Associated Press.

NOTE: The Seattle Post Intelligencer has posted an article which reports:

“The company at the center of a nationwide pistachio recall says the salmonella contamination could have come from raw nuts during processing but not a human or animal source in its plant.”

Read their entire article at:
http://www.seattlepi.com/national/1110ap_salmonella_pistachios.html

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

FDA News
FOR IMMEDIATE RELEASE
March 2, 2009

FDA Takes Action Against KV Pharmaceutical Company
Company Making, Marketing and Distributing Adulterated and Unapproved Drugs
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

For more information:

FDA/CDER Web page on Compliance with Current Good Manufacturing Practices
http://www.fda.gov/cder/dmpq/

FDA’s ongoing efforts against marketed unapproved drugs
http://www.fda.gov/cder/drug/unapproved_drugs/

Federal Agents Seize more than $24M in Unapproved New Drugs
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01868.html

Ethex Corporation Initiates Nationwide Recall
http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html

KV Voluntarily Suspends Shipments of all its Approved Tablet Drugs
http://www.fda.gov/oc/po/firmrecalls/kv12_08.html

Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm

EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

___

Baker reported from Raleigh, N.C.

___

On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.

By GREG BLUESTEIN
Associated Press Writer

ATLANTA (AP) — First, federal investigators said Stewart Parnell knowingly shipped salmonella-tainted foods even after internal tests showed they were contaminated. Then they revealed the evidence: e-mails Parnell sent to his employees urging them to ship out the products that authorities say ultimately sickened hundreds and may have caused the deaths of nine.

Federal authorities, who started an investigation last month, have remained tightlipped about possible charges against Parnell. So has the FBI, which raided the company’s Georgia plant about a week ago.

But food safety attorneys say prosecutors have an array of options for what could be one of the Food and Drug Administration’s most high-profile tainted food cases in decades.

“Any time you’ve got interstate commerce, those are the buzz words for federal prosecution,” said Kent Alexander, a former U.S. attorney in Atlanta who is now general counsel at Emory University. “And prosecutors can be very creative in alleging schemes involving interstate commerce.”

One tool federal prosecutors could use is the 1938 Federal Food Drug and Cosmetic Act, which carries a maximum penalty of three years in prison and a fine of $10,000 if prosecutors prove there’s an intent to “defraud or mislead.”

Prosecutors could also turn to a range of other laws if they are seeking a tougher punishment.

Fred Pritzker, a food safety lawyer in Minneapolis who filed a wrongful death lawsuit against Peanut Corp., said investigators could charge Parnell with federal anti-conspiracy charges.

Or authorities could charge Parnell and his company with mail fraud or wire fraud if prosecutors believe they can prove they were knowingly giving customers adulterated product, said Jim Frush, a former federal prosecutor who is now a criminal defense attorney.

And Alexander said the ongoing investigation could yield a separate, perhaps indirect, charge.

“In cases like this, sometimes the biggest vulnerability people have is lying under oath or lying to federal investigators,” he said.

Authorities say a Blakely, Ga., plant run by Parnell’s company, Peanut Corp. of America, is the sole source of a salmonella outbreak that has led to one of the nation’s biggest food recalls. The company filed for Chapter 7 bankruptcy protection Friday.

Prosecutions in such cases are fairly rare, and they generally lead to fines against companies rather than jail time or other punishments for individuals. Recent convictions include the 1996 case against juice-maker Odwalla Inc., which was fined $1.5 million on charges of shipping unpasteurized apple juice that killed a baby. Five years later, Sara Lee Corp. was fined $200,000 after pleading guilty to misdemeanor charges of selling tainted meats in a listeria outbreak that killed 15 people.

Other, more high-profile outbreaks haven’t yielded criminal charges. Prosecutors decided not to press charges against two produce companies involved in a 2006 tainted spinach case that killed three people and sickened 200 others, saying the investigation found growers and processors did not deliberately skirt the law.

Parnell’s e-mails, released this week by House investigators, depict a man driven by profits who instructed his employees to ship out products despite reports that salmonella was detected. “Turn them loose,” he said in one e-mail.

Parnell, summoned by congressional subpoena, repeatedly invoked his right not to incriminate himself. Reached by telephone Friday, he said his attorneys had advised him not to talk. The company, in statements, has said it is cooperating with federal investigators.

Food safety watchdogs have long argued that the FDA doesn’t pursue criminal charges enough in tainted food cases, but they have little doubt that investigators are building a case as public outrage grows.

“I am no attorney,” said Mike Doyle, a University of Georgia food safety scientist. “But the evidence appears to be a smoking gun. It appears that Mr. Parnell knowingly ordered shipment of salmonella-contaminated product.”

Creighton Magid, a Washington-based products liability attorney often on the defense side, said prosecutors may not press charges in food safety cases because they don’t want to discourage responsible companies from coming forward with their mistakes.

Parnell’s case, he said, appears to be a sharp contrast.

“There’s a huge difference between a recall of a product because of a flaw in manufacturing and knowingly selling a product that is contaminated,” he said. “That’s a different ball game entirely.”

Either way, food safety attorneys say the revelations this week could be the opening act of one of the most high-profile tainted food prosecutions in recent history.

“The question is not whether there will be charges,” said Bill Marler, a food safety lawyer who has filed lawsuits against Parnell’s company. “But what they will charge him with.”

___

On the Net:

U.S. Food and Drug Administration, http://www.fda.gov/

Copyright 2009 The Associated Press.

By MARY CLARE JALONICK
Associated Press Writer

WASHINGTON (AP) — The Agriculture Department shipped possibly contaminated peanut butter and other foods to schools in at least three states under a contract with the Georgia company blamed for a nationwide salmonella outbreak.

The government abruptly suspended all business with the company Thursday, as officials defended their efforts to halt the outbreak that has sickened at least 575 people in 43 states. At least eight have died. It’s become one of the largest food recalls ever, including more than 1,300 products.

The potentially contaminated products went to school free lunch programs in California, Minnesota and Idaho in 2007, the Department of Agriculture said Friday. Peanut butter and roasted peanuts processed by the Peanut Corp. of America were sent to the schools.

None of the states reported illnesses as a result of students eating the recalled peanut products.

Jim Brownlee, a spokesman for the Agriculture Department, said there have been no potentially contaminated shipments from the company in the last year. It was unclear how much of the suspect food might still remain uneaten at the schools.

Despite ongoing reports of illnesses linked to the company, the Agriculture department only Thursday suspended Peanut Corp. from participating in government contract programs, for at least a year. Agriculture Secretary Tom Vilsack also removed Stewart Parnell, president of the company, from USDA’s Peanut Standards Board.

The company’s actions indicate that it “lacks business integrity and business honesty, which seriously and directly hinders its ability to do business with the federal government,” said David Shipman, acting administrator of USDA’s Agricultural Marketing Service, said in a statement.

The recalled foods used ingredients from the Peanut Corp. processing plant in Blakely, Ga. While the outbreak appears to be slowing down, new illnesses are still being reported.

School officials across the country have been checking cafeterias and vending machines for the recalled products, and some have stopped serving any peanut-related products at all, out of an abundance of caution.

The Food and Drug Administration learned only weeks ago that the Peanut Corp. of America had received a series of private tests dating back to 2007 showing salmonella in their products from the Georgia plant, but later shipped the items after obtaining negative test results.

The Agriculture Department initially said that school meal programs were not affected by the large-scale recall. But that changed when Peanut Corp. expanded its recall to all peanut products made at the plant since Jan. 1, 2007.

At a Senate hearing Thursday on the salmonella outbreak, lawmakers reacted angrily when told that food companies and state safety inspectors don’t have to report to the FDA when test results find pathogens in a processing plant, leaving the federal government in the dark.

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR and BRETT J. BLACKLEDGE
Associated Press Writers

WASHINGTON (AP) — Federal health officials are defending their handling of the nationwide salmonella outbreak, telling Congress they had been hot on the trail of a Georgia processor even before they were certain that peanuts were to blame for hundreds of illnesses.

The Food and Drug Administration “began its investigation prior to having a strong epidemiological link to a particular food,” Stephen Sundlof, head of the agency’s food safety center, said in testimony prepared for delivery to the Senate Agriculture Committee.

The first signs of the outbreak were detected in November by the Centers for Disease Control and Prevention. But disease detectives initially suspected chicken was the culprit in clusters of salmonella infections that states were reporting.

On Jan. 7 and 8, after discussions between federal and Minnesota authorities, peanut butter was added to the short list of suspects when some people who had gotten sick reported eating peanut butter in nursing homes and at an elementary school. On Jan. 8, the FDA visited an Ohio distributor for Peanut Corp. of America.

The next day federal inspectors were at the company’s Blakely, Ga. facility, which ultimately was identified as the source of the food poisoning. That same day, Jan. 9, Minnesota health officials found salmonella in an open container of peanut butter made at the plant. On Jan. 10, Minnesota made a positive match to the salmonella strain that caused the outbreak.

Lawmakers, however, may not be reassured. They are concerned about the state of the national food safety system, a collaboration between the FDA, CDC and authorities in each state. As the list of recalled items containing peanut products surpasses 1,000, lawmakers are vowing to press for stronger food safety laws and more money for inspections.

“To say that food safety in this country is a patchwork system is giving it too much credit. It is a hit or miss gamble, and that is truly frightening,” said Agriculture Committee Chairman Sen. Tom Harkin, D-Iowa. “It’s time to find the gaps in the system and remedy them.”

The salmonella outbreak has sickened at least 550 people in 43 states, eight of whom have died. New cases are being reported, although the outbreak is slowing.

The Peanut Corp. plant in Blakely, Ga., which produces a tiny share of U.S. peanut products, is being blamed. Authorities say the facility shipped peanut butter, paste and other products that had tested positive for salmonella. The company retested, got a negative reading, and shipped the products.

A criminal investigation is under way. The company has denied any wrongdoing and said Wednesday that its Blakely plant had received regular visits and inspections from state and federal authorities in 2008 and had gotten a “superior” rating from an independent inspection.

As the list of recall list grows, Assistant Surgeon General Ali Khan said it’s a textbook example of an ingredient-driven outbreak.

“The event illustrates how a large and widespread outbreak can occur from distribution of a single item to hundreds of foods,” Khan said in his prepared testimony.

Meanwhile, lawmakers are dusting off food safety legislation that went nowhere under administration of former President George W. Bush and are hoping for better luck under President Barack Obama, who has criticized the FDA’s handling of the outbreak.

But it remains unclear whether Congress can deliver major improvements in food safety this year, given the press of critical issues such as the shaky economy and a ballooning federal deficit.

All the reform proposals would give the FDA authority to order recalls, which are now voluntary.

Reformers also agree that food processing plants should be required to have a safety plan and document their compliance. And there is widespread agreement that standards for imported foods must be upgraded.

There’s also consensus that inspections should be carried out according to common requirements, but legislators differ on how frequently checks should be performed.

There’s agreement on the need for standards for fresh produce, but there are differences over setting up a tracking system to find foods implicated in an outbreak.

One of the bills calls for taking food safety away from the FDA, where it is sometimes seen as a bureaucratic stepchild, and setting up a new Food Safety Administration within the Health and Human Services Department.

William Hubbard, a former FDA associate commissioner, said no reforms can succeed without more money. He says Congress must double the FDA’s food safety budget to about $1 billion a year.

But even with that, Hubbard warned, the agency would not be able to regularly inspect some 150,000 facilities that produce, ship and store foods. He says the answer is a food safety system in which the FDA sets rules that all players in the food industry must comply with and that states help to enforce.

___

On the Net:

The FDA’s recall page: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — Worried about salmonella, the Army said Thursday it’s removing some peanut butter items from warehouses in Europe, the latest in an ever-growing list of recalled peanut products linked to a national salmonella outbreak.

Already more than 430 kinds of cakes, cookies and other goods in the civilian world have been pulled off store shelves in what the Food and Drug Administration is calling one of the largest product recalls in memory. The Army’s recall does not affect Meals-Ready-to-Eat, but another kind of military grub called Unitized Group Rations-A, which provide a complete 50-person meal.

More than 500 people have gotten sick in the U.S. outbreak, and at least eight may have died as a result of salmonella infection.

At the center of the investigation is a Georgia peanut processing plant where federal inspectors reported finding roaches, mold, a leaking roof and other sanitary problems.

Managers at the Blakely, Ga., plant owned by Peanut Corp. of America continued shipping peanut products even after they were found to contain salmonella, the FDA said. The company shipped the food items after retesting them and getting negative results.

Peanut Corp. expanded its recall Wednesday to all peanut goods produced at the plant since Jan. 1, 2007. The company makes just 1 percent of the peanut products sold in the United States, but those products are ingredients in hundreds of other foods, from ice cream, to Asian-style sauces, to dog biscuits. Major national brands of peanut butter are not affected.

A senior lawmaker in Congress and Georgia’s agriculture commissioner called for a criminal probe of the company, but the FDA said that would be premature while its own food safety investigation continues.

The company says it is fully cooperating with the government and has stopped all production at the plant. Peanut Corp. said in a statement it “categorically denies any allegations that the company sought favorable results from any lab in order to ship its products.”

Stewart Parnell, the firm’s president, said that the recall was expanded out of an abundance of caution.

“We have been devastated by this, and we have been working around the clock with the FDA to ensure any potentially unsafe products are removed from the market immediately,” Parnell said.

Most of the older products in the expanded recall have probably been eaten already. Officials said they see no signs of any earlier outbreaks from those goods.

The recall covers peanut butter, peanut paste, peanut meal and granulated products, as well as all peanuts — dry and oil roasted — shipped from the factory. FDA officials could not quantify the amount of products being recalled.

Officials recommend that consumers check the FDA web site, which lists all the products being recalled, and toss out any that are named.

Salmonella had been found previously at least 12 times in products made at the plant, but production lines were never cleaned after internal tests indicated contamination, FDA inspectors said in a report. Products that initially tested positive were retested. When the company got a negative reading, it shipped the products out.

That happened as recently as September. A month later, health officials started picking up signals of the salmonella outbreak.

Michael Rogers, a senior FDA investigator, said it’s possible for salmonella to hide in small pockets of a large batch of peanut butter. That means the same batch can yield both positive and negative results, he said. The products should have been discarded after they first tested positive.

Separately, senior congressional and state officials on Wednesday called for a federal probe of possible criminal violations at the plant.

The company’s actions “can only be described as reprehensible and criminal,” said Rep. Rosa DeLauro, D-Conn., who oversees FDA funding. “This behavior represents the worst of our current food safety regulatory system.”

In Georgia, the state’s top agriculture official joined DeLauro in asking the Justice Department to determine whether the case warrants criminal prosecution.

“They tried to hide it so they could sell it,” said Georgia Agriculture Commissioner Tommy Irvin. “Now they’ve caused a mammoth problem that could destroy their company — and it could destroy the peanut industry.”

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On the Net:

FDA’s recall page: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — A lab company president called to testify before Congress in the salmonella outbreak investigation said Thursday that manufacturers “can’t retest away a positive result.”

Charles Deibel, whose labs conducted tests for Peanut Corp. of America, said that if 100 containers were tested and only one or two turned up salmonella, the company should “throw the whole lot out.”

Federal health officials say Peanut Corp. shipped tainted peanut products from its Blakely, Ga., facility after retesting them and getting a negative result for salmonella.

Peanut butter, peanut paste and other goods from the plant are being blamed for an outbreak that has sickened more than 500 people, triggered a massive international recall and raised doubts about the food industry’s safety practices.

Deibel said his company — Deibel Labs Inc. — did not conduct day-to-day testing for the Blakely plant, but was asked on occasion to carry out certain tests. He said the company has turned over bacterial cultures to federal investigators.

Deibel and the president of another lab, J. Leek Associates Inc., have been called to testify Feb. 11 before the House Energy and Commerce Committee. The Deibel firm has been in existence since the 1960s and has its main lab in Chicago.

Rep. Henry Waxman, D-Calif., chairman of the panel conducting a hearing into the outbreak, said the investigation shows “major gaps” in the nation’s food safety system.

“I am extremely troubled by reports that the plant tested positive for salmonella numerous times but nothing was done to ensure that the product did not go on the market,” Waxman said.

Peanut Corp., based in Lynchburg, Va., said in a statement it “categorically denies any allegations that the company sought favorable results from any lab in order to ship its products.”

Deibel said his firm is still poring over records to determine what kind of testing was done, and at what times, for Peanut Corp.’s plant.

He said his lab tested some salmonella cultures that came from the J. Leek lab and identified the specific variety of the bacteria that was present. Those cultures have been turned over to investigators from the Food and Drug Administration and the Centers for Disease Control.

Darlene Cowart, president of the J. Leek lab, was not available Thursday.

Deibel his lab also tested samples of peanut products sent directly from the Blakely facility, but that he did not have the results of those tests available.

Salmonella can exist in a dormant state in products like peanut butter, isolated in pockets of a big batch. So experts say it’s possible to get positive and negative results from the same batch.

“The benefit of using multiple labs is you increase your chances of finding it,” said Deibel.

“Our recommendation to clients is that you can’t retest away a positive result,” he added. “We call it ‘testing into compliance,’ and that is frowned upon.”

Meanwhile, the Army joined the peanut recall Thursday. It’s removing some peanut butter items from warehouses in Europe.

In the civilian world, more than 430 kinds of cakes, cookies and other goods have been pulled off store shelves in what the FDA is calling one of the largest product recalls in memory. The Army’s recall does not affect Meals-Ready-to-Eat, but another kind of military grub called Unitized Group Rations-A, which provide a complete 50-person meal.

Nationwide, at least eight people may have died of illnesses linked to the outbreak.

The recall covers peanut butter, peanut paste, peanut meal and granulated products, as well as all peanuts — dry and oil roasted — shipped from the factory. FDA officials could not quantify the amount of products being recalled.

Officials recommend that consumers check the FDA web site, which lists all the products being recalled. Consumers who find any such products in their cupboards should toss them away. If they’re uncertain about eating a particular product, they should check it out first.

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On the Net:

FDA’s recall page: http://tinyurl.com/8srctw

Copyright 2009 The Associated Press.