Food Poisoning Lawyer & Attorney : Marler Clark : Food Poison Blog

As the year comes to a close, many publications are looking back on the year and assessing our nation's food safety system.  From the Wall Street Journal to USA Today and Reuters, everyone has something to say about the American food supply. 

The Wall Street Journal focused today on the USDA and the number of E. coli outbreaks in 2007.  Bill Tomson wrote about the Topps E. coli outbreak and the impact it has had on USDA's food safety policies:

It took one of the largest-ever beef recalls -- 21.7 million pounds of frozen hamburger patties linked to severe illnesses -- in 2007 to make USDA officials question whether beef processors around the country were following safety guidelines when it came to E. coli contamination. The New Jersey-based Topps Meat Co., the producer behind the massive recall, certainly wasn't, USDA officials said.

"When we sent food-safety assessors into the Topps plant, we found that their policies they had in place were not being followed nearly as vigorously as they had been just two years ago when we did a food-safety assessment in the same plant," USDA Under Secretary for Food Safety Richard Raymond said in an interview.

The Topps event led to several tough questions. The first was whether the Topps situation was unique.

"We don't know if Topps was the tip of the iceberg and other plants have gotten sloppy, or Topps was kind of an isolated incident," Mr. Raymond said.

USA Today focused on under-funding at the FDA and what that means for American consumers purchasing food products regulated by FDA.  Julie Schmidt wrote:

The appropriation is 12% more than the agency got for food safety in fiscal 2007. But half the increase will be eaten up by annual cost increases, including pay raises, and the FDA won't get the other half until July — and only then if it has a performance plan in place that lawmakers find adequate.

"In the budget climate we're in, any increase is better than nothing," says Scott Faber of the Grocery Manufacturers Association, which represents foodmakers. "But we're disappointed and surprised in light of soaring imports and declining consumer confidence." A broad coalition of groups, including the GMA, have pushed for bigger food-safety increases in the past year because of a string of high-profile food recalls. The Coalition for a Stronger FDA, which includes three former secretaries of Health and Human Services, which oversees the FDA, has sought 15% increases for the FDA for each of the next five years.

And Reuters carried an article about foods imported from China and Americans' worries about foodborne illness coming from Chinese imports.  Missy Ryan wrote:

China is struggling to meet food safety demands from trading partners as it slowly modernizes a food production system still rooted in small-scale family farms, U.S. and Chinese officials said on Tuesday.

"China is a country in economic transition and it has a mixture of traditional problems and modern problems that both coexist," Wu Yongning, an official at the Chinese Center for Disease Control and Prevention, said in a seminar on food safety at a Washington think tank.

Those problems, he said, now range from improper food preparation on family-run farms to shortcuts taken on industrial chicken farms.

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John Munsell, a former meat-processing facility owner, was recently interviewed by Meat & Poultry Magazine about what he learned while conducting interviews of industry players.  While Munsell has been a critic of USDA meat inspection practices and policies, he is working for change through FARE, the Foundation for Accountability in Regulatory Enforcement.  What he had to say about his findings follows:

Munsell said that judging from the comments his survey elicited, inspectors appear to be as frustrated about the situation as small-plant operators. "Meat-inspection personnel are throwing their hands into the air, as they again are being forced to implement policy, which was stillborn before it left Washington, D.C.," he told M&P. "The OPEER office in FSIS is totally closed to new suggestions, and bulldozes ahead with no semblance of common sense or scientific underpinnings. Agency field personnel must quietly acquiesce to these inane demands, or face diminished career advancement and/or reassignment to remote locations without family."

When he’s talked to researchers and scientists about his concerns, their reaction to current E. coli inspection policy is, he said, "incredulous." "They remind me that the scientific method requires immediate and thorough documentation of every factor potentially influencing the eventual outcome, with no artificial restrictions. Yet when FSIS inspectors collect samples for analysis at USDA labs, the inspectors do not document the origin of the meat," he said. "The official form has no place on which to record the data, and the inspectors are not to document such info. So what happens if the sample comes back positive? Simple: blame it on the downline plant, since the agency failed to record where the meat originated. This is not the scientific method. If our foreign trading partners were aware of this snafu, they’d be justified in blacklisting us."

Meat & Poultry's coverage of current issues facing USDA are in line with problems FDA is facing in policing the rest of the food supply.  In a hearing last week, Michael Taylor testified that FDA's current food safety plan is not adequate to protect public health.  Mr. Taylor outlined five policy elements he thinks FDA needs to take to improve our nation's food supply in testimony before the Senate Committee on Health, Education, Labor and Pensions. 

1. Treat food safety as a farm-to-table, system-wide problem.

2 Make prevention of food safety problems the central focus of the system.

3. Recognize that the primary duty for prevention falls on the food industry.

4. Focus FDA on setting and enforcing standards that make the food industry accountable for prevention.

5 Strengthen FDA’s mandate and tools for providing national leadership on food safety and managing a science- and risk-based regulatory program.

Mr. Taylor's testimony was central to the committee's session on developing a comprehensive response to food safety, after which they asked for more money dedicated to food safety. 

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USA Today published two articles about food safety for this weekend's USA Today.  In the first article, titled, "Report: FDA so underfunded, consumers are put at risk," Julie Schmidt reports on a report that was released by an advisory panel to the FDA which concludes:

The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.

The Subcommittee found that the deficiency has two sources:

• The demands on the FDA have soared due to the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for pre-market review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates.
• The resources have not increased in proportion to the demands. The result is that the scientific demands on the Agency far exceed its capacity to respond. This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.
  

The Subcommittee further noted that the impact of the deficiency is profound precisely because science is at the heart of everything FDA does. The Agency will flounder and ultimately fail without a strong scientific foundation. That foundation rests on three pillars. The first pillar is strong selective scientific research programs that are appropriately mission-supportive, in all areas of FDA responsibility. This research is critical because it is not conducted by other public or private entities, but is fundamental to the discharge of FDA’s statutory responsibilities to protect and promote the public health. The second pillar is excellent staff with cutting-edge scientific expertise appropriate to the mission. This expertise includes the ability to access, understand and evaluate science; effectively apply this science to the regulatory process; and communicate the implications of its findings for product safety and efficacy to the public. The third pillar is an information infrastructure and processing capability that ensures the FDA has access to the best data and information necessary to support the regulatory science required to fulfill FDA’s mission.

The USA Today article provides more background on the report, and highlights deficiencies identified by the advisory committee:

The report — developed in the past year by experts from academia, industry and other government agencies — delivers a scathing review of the state of the FDA, which regulates 80% of the nation's food, its drugs, vaccines and medical devices.

The report details a "plethora of inadequacies" in the agency, including:

•Inadequate inspections of manufacturers, noting that foodmakers, for example, are inspected about once every 10 years.

•A "badly broken" food-import system and food supply "that grows riskier each year." In the past 35 years, FDA inspections of the food supply have dropped 78% due to soaring numbers of products and inadequate FDA funding.
FIND MORE STORIES IN: Food and Drug Administration | Food and Drug Administration | William Hubbard

•A depleted FDA staff, which is about the same size as it was 15 years ago despite huge growth in agency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.

•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.

•An "obsolete" information-technology system.

As Bill Marler stated on his blog post titled, "Government Puts Consumers At Risk": 

The report says Congress has given the FDA more responsibilities over the past two decades, but no funds to cover the extra work. Meanwhile, the agency hasn't been able to recruit the sophisticated scientific expertise needed to oversee complex medicines and food. The report says the FDA needs at least an extra 350 million dollars to address drug safety, and 450 million more dollars to improve food safety. Actually, the same holds true for the USDA. Just in the last two months we have seen the USDA move slowly on the Topps recall, putting people at risk, and then we see them announce one day that the USDA is getting tough on Canadian E. coli imports, only to turn around quietly and stop testing a week later.

His comments are along the lines of another USA Today article's topic - the USDA.  Julie Schmidt partnered with Barbara Hansen to write, "Most recalled meat is never recovered, likely is eaten," an article about meat recalls conducted by the United States Department of Agriculture.  In the article, Schmidt and Hansen describe the current recall process and point out inefficiencies that result in ineffective recalls.

A particularly alarming statistic pointed out in the article is that ,"for five recalls that followed reports of consumer illness, recovery rates per recall averaged just 20%," which means that most of the meat recalled had already been eaten or was in consumers' freezers but never made it back to the manufacturer.  Improvements in the recall process are expected to come, but what is most promising in the short-term is, as reported:

To get more consumers to check homes for recalled meats, the USDA next year plans to publicize names of retailers selling meat that was later recalled. "We think it would be helpful for people to know, 'Gee, that is my store,' " says Petersen.

Recall notices now posted on the USDA's website typically name states where a product was sent but not retailers, unless their names are on the product. Retailer names have been considered confidential business information, as with any customer lists.

While much more must be done to improve our food safety system, the FDA report and USDA's proposed improvements to the recall process are baby steps in the right direction.

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Today, the recommendations of an advisory committee which was formed to assess the safety of the nation's food supply will issue a report to President Bush and Congress.  An article that appeared last night on the New York Times website provided some insight into the reasons behind the formation of the committee and what will be included in the report:

Neither the FDA nor the USDA had the authority to order ConAgra to recall the products. In fact, all food recalls, except for those involving infant formula, are voluntary. Often, the government gets a product recalled by warning the company it could face bad publicity if it does not withdraw the food.

An advisory committee created in response to concerns about recalls of imported products -- including dog food and toothpaste -- will suggest changing that.

The commission, created in July in response to concerns about recalls of imported items, will recommend to President Bush that the FDA be empowered to order recalls of products deemed a risk to consumers, an administration official said Monday. Congress would have to approve such a step.

Here is what critics who were interviewed had to say of the food supply as it is: 

''FDA's food program is very small compared to its task.''  -- William Hubbard, a top FDA official for 14 years.

''I think the food industry has a very long history of not doing anything on food safety unless it has to.''  -- Marion Nestle, a New York University professor who wrote a book on food safety.

Bill Marler, another food industry critic, recently wrote in Food Safety Magazine:

Ultimately, dedication to food safety must go beyond the company's HACCP programs in terms of compliance, implementation, testing and auditing. This commitment starts at the top of the organization with the CEO, president and senior management team. Managing the business in a way that pays more than lip service to food safety will produce high-quality, profitable products that don't make people sick, and is essential to the continued health of your bottom line and the health of your consumers.

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Newsinferno.com added a post titled, "CDC, FDA, ConAgra or Peter Pan himself, Who’s to Blame for the Underreporting of Sickening and Potentially Deadly Salmonella & E-Coli Food Poisoning Cases?" which offers an interesting discussion on foodborne illness outbreaks.  

The federal agency responsible for insuring food safety was also been taken to task for its role in the incident. In April 2007, the Washington Post published documents proving that the FDA, as well as ConAgra, knew of contamination problems at the plant as far back as 2004. The agency took few corrective measures, assuming that ConAgra would address the situation itself. ConAgra apparently did little to nothing to fix the problem.

And this was not the first time the FDA knew about food safety problems but did little to correct them. The Post article also cited evidence that the agency had been aware of problems with contaminated spinach and other California greens as far back as 1995. In the fall of 2006, hundreds of people were sickened and three were killed after contracting e-coli from contaminated California Spinach.

Critics say that under-funding and a lack of trained inspectors at the FDA have left the nation’s food supply in a perilous condition. A congressional fact sheet published by Henry Waxman (D-Calif) in 2006 said funding for the FDA fell short by $135 million. The number of scientists employed by the FDA’s food division dropped from 1,000 to 800 in the past three years. This decrease in personnel and the ongoing budget cuts have overwhelmed the agency, greatly impacting its ability to watch over the food supply. The results of this shortfall are apparent — according to the CDC, contaminated foods cause 325,000 hospitalizations and 5,000 deaths each year.

Maybe Newsinferno.com will post about the recent E. coli outbreaks traced to ground beef and include USDA in its next analysis.

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In an article titled, "The Feds are Still Looking for the E. coli," Salon.com writer Michael Scherer discusses two recent E. coli outbreaks - one in Pennsylvania and one in California.  In Scherer's article, he focuses on USDA's attempts to find the source of an E. coli outbreak, and its inability, or unwillingness, search beyond a final meat processor to a supplier or slaughterhouse "upstream".

The two separate E. coli outbreaks subsequently demonstrated both the strengths and ongoing weaknesses of the troubled federal food safety system, which has been under recent scrutiny because rising rates of E. coli sickness. Within weeks, nationwide recalls were announced for nearly 400,000 pounds of meat, and two local meat-processing facilities were temporarily shuttered. But federal food safety inspectors have not yet been able to track down the original slaughterhouses that probably caused the outbreak, leaving open the possibility that more contaminated food is still in the food system. Meanwhile, smaller meat-processing firms that are probably blameless bear the financial brunt of the recalls.

Scherer interviewed Bill Marler and John Munsell, both key players in the ConAgra E. coli outbreak in 2002, about USDA's traceback abilities. 

The current problems can be traced to USDA regulations first put into place in 1994. Under those rules, small meat processors who mechanically tenderize or grind USDA-approved beef from outside slaughterhouses became legally responsible for any "adulterants" like E. coli in the final product. "Whoever grinds it gets stuck with the problem," explains Bill Marler, a Seattle trial lawyer who specializes in food poisoning cases. "If the product has E. coli on it, they are on the hook. It is an unfair situation."

The rules have resulted in inspectors who have historically shown little interest in finding the source of the contamination, with sometimes disastrous results. In 2002, E. coli-contaminated beef from a ConAgra slaughterhouse in Greeley, Colo., sickened 46 people in 16 states and killed a woman in Ohio. But months before most of the illnesses became apparent, two small meat processors, including a plant run by Munsell, received positive tests for E. coli from boxed beef that had been sent from the Greeley plant. Federal meat inspectors blamed the processing plants and initially refused to trace the contamination back to its source. "Existing policy stated that the grinders should be held accountable for ensuring the product that they purchased was wholesome," explained the USDA's inspector general in a damning report about the incident. "FSIS was slow to react."

Marler has commented on USDA's recall abilities and its partnership with the meat industry several times, including his essay titled, "E. coli and the Church Picnic," which is posted at his blog, and an Associated Press article titled, "USDA withheld information from state in E. coli investigation," an excerpt of which is also poted at marler's blog.

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