Harkin: FDA oversight does not work

From the office of Sen. Tom Harkin:

Reacting to the news that yet another Peanut Corporation of America plant was closed after Salmonella was detected at the facility, Senator Tom Harkin (D-IA) today said that FDA oversight of state inspections of food processing facilities does not work. Previous media reports have shown that this plant may have gone four years without a food safety inspection, a fact confirmed by FDA officials last week. The Salmonella outbreak has killed eight and sickened 600 nationwide, including three in Harkin’s home state of Iowa.

“Hundreds of people sickened and in the worst cases, lives lost – all because of a food-borne illness. We’ve been here before, and we cannot afford to be here again,” said Harkin. “This inspection systems does not work. Our committee heard firsthand of the lapses last week and now we are seeing the results of food processing facilities that go uninspected.”

At a hearing before the Senate Agriculture Committee last week, which Harkin chairs, FDA officials testified that the Peanut Corporation of America’s own testing found 12 incidents of Salmonella at the plant since 2007. Under law, the company does not have to report these findings to the FDA and despite these warnings, the last time federal inspectors were sent to the plant, prior to the recent Salmonella outbreak, was in 2001.

Following the hearing, Harkin called for FDA to release to Congress records detailing the inspection report from the Georgia state Department of Agriculture to conduct food safety inspections of the Peanut Corporation of America plant. The FDA has yet to submit the documents. Today, Harkin sent a letter to the agency pressing them for the documentation.

“Before another American gets sick, before another child eats a peanut product that may be contaminated, Congress must get to the heart of this matter,” he concluded. “I urge the FDA to release the records on state contracts immediately.”

The full text of the letter follows.

February 11, 2009

Dr. Stephen Sundlof

Director, Center for Food Safety and Applied Nutrition

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20903

Dear Dr. Sundlof:

The record of the hearing of this Committee on Thursday, February 5, 2009, including your testimony at that hearing, shows that prior to the recent Salmonella outbreak, FDA last inspected the Blakely, GA Peanut Corporation of America plant in 2001. FDA contracted with the state of Georgia to inspect the plant in 2006. During the time period from 2001 to 2006, the plant was not inspected by FDA but was inspected by Georgia state authorities, but not under direction of or under contract with FDA. In 2007 and 2008 shipments that PCA testing showed positive for Salmonella left the plant and made their way into the food supply. When the FDA inspected the plant in January 2009, several violations of processing plant cleanliness standards were discovered. According to FDA records, was this the condition of the plant during the time that the FDA contracted with the state of Georgia for inspections?

During the hearing, I requested from FDA copies of relevant records and documents involving inspections by Georgia state authorities. Please provide documents covering the period from FDA’s last inspection in 2001 forward and which include all reports or communications involving inspections of the plant by Georgia state authorities, including dates and the number of inspections, all communications and reports regarding such inspections that are in the possession of FDA, and PCA internal laboratory test results. For each document, please specify when the FDA received these documents. What findings did the reports to the FDA concerning the inspections contain and were more corrective actions prescribed by the FDA?

Additionally, I request the inspection report from 2009 for PCA’s plant in Plainview, TX and laboratory test results resulting from this inspection. What findings did the reports to the

FDA concerning the inspections contain and were more corrective actions prescribed by the FDA?

Thank you for your testimony at the hearing and for your follow-up to provide these requested documents.Sincerely,

Tom Harkin

Chairman

Harkin to FDA: submit records of contracts with states

From the office of Sen. Tom Harkin today:


During a food safety hearing before the Senate Agriculture Committee today, Chairman Tom Harkin (D-IA) called on the Food and Drug Administration (FDA) to submit to Congress records detailing contracts with state Departments of Agriculture to conduct food safety inspections of private companies. The request came on the heels of the recall of peanuts and peanut products from the Peanut Corporation of America, which has been linked to a Salmonella outbreak that has killed eight and sickened 575, including three in Harkin’s home state of Iowa.
“We know what happens when federal oversight is deregulated,” said Harkin. “We saw the impact of deregulation on our financial sector and now we are seeing the impact of weak oversight on food safety inspections. To say that food safety in this country is a patchwork system is giving it too much credit. Food safety in America has too often become a hit-or-miss gamble, and that is truly frightening.”
During testimony before the Committee, the FDA testified that the Peanut Corporation of America’s own testing found 12 incidents of Salmonella at the plant since 2007. Under law, the company does not have to report these findings to the FDA and despite these warnings, the last time federal inspectors were sent to the company was in 2001. Instead, the FDA relied on the company to remedy the problems. Yesterday, media reports showed a Texas company linked to Peanut Corporation, which had been contracted out to the Texas Department of Agriculture for inspection, had not been inspected by either federal or state officials for almost four years.“FDA is increasingly relying on states to conduct food safety inspections and this system is not working. I urge the FDA to submit to Congress details of the contracts and inspection reports with individual states immediately as we work to close the gaping loopholes in our nation’s food safety system,” he concluded.

Opening statement - Sen. Tom Harkin at Senate Ag Commitee on federal food safety oversight

From the office of Sen. Tom Harkin this morning;

“Good morning. I welcome everyone to the Committee.

“Forgive me, but I’m going to skip the niceties and get right to the point. I am nothing short of outraged at the increasing number of outbreaks of food-borne illness in this country. Everything from spinach and lettuce to beef products and, now, peanut products has been implicated. Within the last year, we had the biggest recall ever under USDA jurisdiction. And just in the last month, with the recall of peanut products from the Peanut Corporation of America, we had one of the largest recalls ever under FDA jurisdiction.

“To say that food safety in this country is a patchwork system is giving it too much credit. Food safety in America has too often become a hit-or-miss gamble, and that is truly frightening. When Americans can’t count on the safety of basic items that go into our children’s lunch boxes, then we are in big trouble.

“The Centers for Disease Control and Prevention tells us that there are 76 million cases of food-borne illness annually in the U.S., resulting in 325,000 hospitalizations and 5,000 deaths. Those statistics would be disturbing anywhere in the world. They are totally intolerable in the United States of America.

“Reducing the instances of food-borne illness in this country means examining every step in the food safety process.

“Our systems for tracing tainted products and removing them from commerce must be stronger, better coordinated, faster, and more efficient. Regardless of the level of contamination, we need to be able to identify the source accurately, promptly, and act quickly.

“As in all of health care, prevention of the illness is the key. Prevention is much less costly than the treatment. We must focus on getting the food safety done right in the first place, before the pathogens get into the food.

“Bear in mind that this is both a health issue – and it is also an economic issue. It is inevitable that demand for the food crop involved in the outbreak will fall sharply. During a recall, retailers lose business, processors lose customers, and – as our Ranking Member, Senator Chambliss knows all too well – farmers suffer as well. Entire communities can face economic devastation.

“We have got to come up with a better, smarter approach to food safety. We have got to make the investments both in better systems, and in putting more inspectors on the ground. This is about the integrity of our food supply. And it is about the health and wellness of our people.

“So our goal, this morning, is to explore what went wrong, and what we need to do to get things right. We have a distinguished panel of witnesses. I look forward to your best counsel as to how we can do a far better job of preventing outbreaks . . . and, when outbreaks happen, how we can do a better job of stopping them very early on before they spread.

“With that, I will now turn to Ranking Member Chambliss for his opening remarks.”

Thursday oversight hearing - Senate Agriculture Committee

Next couple of weeks should be a time to take measure of legislative efforts to reform food safety. Senate Ag this week, House Energy and Commerce next week. From the office of Sen. Tom Harkin:

Senators Tom Harkin (D-IA) and Saxby Chambliss (R-GA), the Chairman and Ranking Member of the Senate Committee on Agriculture, Nutrition and Forestry, today announced the list of witnesses who will testify during a hearing “Examination of Federal Food Safety Oversight in the Wake of Peanut Products Recall.” The committee will meet in open session at 10:00 AM on Thursday, February 5, 2009 in Room 216 of the Hart Senate Office Building.

Witnesses for the proceeding will include:

Panel I

Dr. Stephen Sundlof, Director, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Rockville, MD

Dr. Ali S. Khan, Assistant Surgeon General and Deputy Director of the National Center for Zoonotic, Vector-borne, and Enteric Diseases, Center for Disease Control, Atlanta, GA

Panel II

Ms. Gabrielle Meunier, Mother of affected child, South Burlington, VT

Ms. Caroline Smith DeWaal, Director, Program on Food Safety, Center for Science in the Public Interest, Washington, DC

Mr. William Hubbard, Former Senior Associate Commissioner for Policy, Planning and Legislation, Food and Drug Administration, Chapel Hill, NC

Crushed peanuts

The salmonella outbreak linked to peanuts may be the event that finally gives food safety reform real traction. President Obama has called for a review of the FDA today, while members of Congress are also chiming in. From the desk of Sen. Tom Harkin:

Senators Tom Harkin (D-IA) and Saxby Chambliss (R-GA), the Chairman and Ranking Member of the Senate Committee on Agriculture, Nutrition and Forestry, today announced a hearing “Examination of Federal Food Safety Oversight in the Wake of Peanut Products Recall.” The committee will meet in open session at 10:00 AM on Thursday, February 5, 2009 in Room 216 of the Hart Senate Office Building.


Meanwhile, from Consumers Union today:

President Obama’s call today for a top-to-bottom review of the Food and Drug Administration (FDA) is good news for consumers, according to Consumers Union (CU), the nonprofit publisher of Consumer Reports magazine. CU said the recall of two years’ worth of production from a peanut butter factory in Georgia underlines critical weaknesses in the FDA’s inspection and enforcement capacity. CU called on Congress to require FDA to inspect such factories annually.

"The FDA is supposed to be a watchdog for consumers, and for too long, this agency has been coming up short,” said Jean Halloran, Director of Food Policy Initiatives for Consumers Union. “The FDA has been so severely weakened by cutbacks in staffing and funding, and is so poorly equipped to deal with today’s food industry, with its mass production and distribution systems and global sourcing of ingredients, that it can no longer keep food safe. The first step in overhauling the FDA should be requiring that processing plants are inspected every year,” said Halloran.

“President Obama’s review and his appointment of a new FDA Commissioner will definitely improve FDA’s use of its existing resources and authority. However, Congress must also act soon to modernize the agency and give it the additional resources and authority it desperately needs,” Halloran said.

“FDA was almost completely unaware of the problems at Peanut Corporation of America (PCA), despite the fact that problems had existed for some time, and that salmonella contaminated peanut butter at another Georgia factory just two years ago,” Halloran added. “Unfortunately, this is not surprising. FDA inspects U.S. food production facilities only about once every ten years on average.”

A recent CU poll found that two-thirds of Americans want the FDA to inspect domestic and foreign food-processing facilities at least once a month.

FDA last visited PCA’s plant in 2001, at which time PCA was only roasting peanuts. FDA admitted on January 30 that it did not even know the plant had started making peanut butter until 2008, when some of its output was turned back at the Canadian border because it contained metal fragments. As a result, FDA failed to inspect the PCA plant until January 2009, even though it had inspected other producers in the wake of the 2007 Georgia ConAgra salmonella peanut butter disease outbreak.

“Oversight of PCA was contracted out to the Georgia Department of Agriculture, which conducted a number of inspections. But there is little evidence that FDA was aware of repeated findings of unsanitary conditions at the plant,” Halloran stated.

CU said more basic reform will require Congressional action. “Congress should require FDA to inspect every food producer in the United States at least once a year, and provide funding through registration fees for this work,” said Halloran. “Congress must give FDA mandatory recall authority, and require companies to disclose the retail stores, schools and nursing homes that get recalled products. And if a company finds an adulterant like salmonella in its own testing, Congress should require that it inform FDA and explain how it disposed of the product,” Halloran added.

Prompted by the 8 deaths and more than 500 illnesses attributed to salmonella in peanut butter produced by PCA, and by the fact that the company apparently shipped product that it knew to be contaminated, Congress has begun considering FDA reform legislation. Representatives John Dingell, Bart Stupak, and Frank Pallone introduced a bill on January 28, and Representative Rosa DeLauro is expected to introduce another bill this week. Senator Durbin is also developing a bill expected to be introduced soon.

CU advises consumers not to eat products containing peanut ingredients like crackers or cookies, unless consumers check with the manufacturer and make sure that none of it comes from PCA.

Guest bloggers and Jan. 6 headlines

It was great to see another Jay Martini post today. If you are a newcomer to the blog, Jay started contributing last year in the midst of the tomato-linked salmonella outbreak and dazzled with straight from the gut reality rants and thoughtful wordsmithing. By the way, the door is open to others out there who would like to be "guest bloggers." Notoriety awaits...

Some headlines snatched from the Web

Organic demand leveling off

A survey by TABS (The Analytical Business Solution) finds demand for organic products has leveled-off. The market research group found less than 40% of adults say they have purchased anything from the major organic categories in the last six months. TABS says of the 1,000 respondents age 18 and above, “Organic fresh fruit had the highest purchase incidence, at 27%, with organic fresh vegetables a close second, at 26%. Organic eggs and milk were bought by 18% and 17% of American adults, respectively. Frozen organic products such vegetables, fruit, and ice cream had low purchase levels, however, at 5 to 6%.

In contrast, nonorganic products for all of the categories included in the study had household penetration levels of well over 70 percent.



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From the office of Sen. Tom Harkin, reaction to news that president-elect Obama will name Iowan Tom Vilsack as his nominee for Agriculture Secretary.

"I am extremely pleased by the news being reported that Tom Vilsack will be nominated as Secretary of Agriculture. I have known Tom Vilsack as a state legislator and as a governor. He knows production agriculture and he knows the changes we need to ensure its profitability and future, including for young and beginning farmers and ranchers. Tom Vilsack has the experience, dedication and forward-looking thinking critically needed to build a better future for all Americans in food, agriculture, conservation, and the economic vitality of rural communities. With these qualifications and his strong Iowa roots, I hope he is indeed nominated for this position."