USDA Whistleblower Comes Forward Amidst GAO Reports

By Nikhil Swaminathan, 10 March, 2010, No Comment

Last week, an 18-year employee of the USDA’s Food Safety Inspection Service, stepped in front of the House Oversight and Government Reform Committee to describe malpractices he saw during his tenure. Dean Wyatt reported seeing pigs inhumanely slaughtered in an Oklahoma plant, as well as calves being mistreated in Vermont. His objections in both instances went unheeded, and, on at least one occasion, the USDA forced him to endure retraining sessions. Wyatt wasn’t taken seriously until the Humane Society of the United States released a graphic video of calves being slaughtered. (See below NSFW.)

As pointed out by the Washington Post, his testimony dovetails with two Government Accountability Office reports: one points out weaknesses in the USDA’s oversight of humane slaughtering methods, the other makes some general suggestions on improvements for better enforcement. (Example: “According to GAO’s survey, FSIS’s training may be insufficient. For example, inspectors at half of the plants did not correctly answer basic facts about signs of sensibility.”)

From Food Safety News comes an exchange from the House Oversight Committee hearing that highlights why we should be concerned with humane slaughtering:

“Is there a connection, in your professional opinion, between humane handing and the safety of food which people consume?” subcommittee chairman [Dennis] Kucinich [D-OH] asked Jerold Mande, deputy under secretary for food safety at FSIS.  “Would you eat meat where the calves were treated like that? Would you consume those products?  Isn’t at some point this a health issue?”

Mande indicated he does believe there is a link between humane treatment and safety. “I think when companies violate the humane slaughter act it’s a demonstration that they don’t have control over their processes,” he told the committee.  “It raises a question on how they can control their food safety processes.”

President Creates Food Safety Working Group. Why Not a Review Board?

By Bala Swaminathan, 16 March, 2009, No Comment

In his radio address yesterday, President Obama announced the creation of a Food Safety Working Group. It will consist of cabinet secretaries and senior officials and will advise the President on how antiquated food laws can be updated for the 21st century, how coordination between various federal agencies can be improved and how current and new food laws and regulations can be effectively enforced.

While this is definitely a step in the right direction, I wish the President had gone further. It is time to create a National Food Safety Review Board to continually review the workings of the various federal agencies involved in food safety and advise the President. An ideal NFSRB would be composed of members who are not presently associated with the executive branch but have extensive previous experience in different aspects of food safety: food laws and regulations, food policy, foodborne disease surveillance and epidemiology, public health microbiology and food microbiology, food production and processing, food sanitation and hygiene and inspection of food processing facilities). The tasks outlined by the President for his Food Safety Working Group will be more effectively performed by an independent review board than a group comprised of the secretaries of the agencies involved in foods safety and the senior officials from those departments.

Specifically, a NFRSB should have the following responsibilities:

  • Periodic review of the priorities of each agency involved in food safety and how effectively they are implementing actions to address these objectives
  • Review whether additional food safety funds requested by the President and appropriated by the Congress are being used for the purposes for which they were provided and whether the implementation has had a measurable positive impact on food safety
    • Example 1: If the Food and Drug Administration is provided additional funding for more food inspectors, the NFSRB will determine how many additional inspections of national and international food processing facilities were conducted and what was the demonstrable public health impact of these increased inspections
    • Example 2: If the Centers for Disease Control and Prevention is provided additional funding to improve surveillance and accelerate outbreak recognition and investigations, the NFSRB will assess the impact of any new programs implemented by CDC to ensure that these steps have resulted in a measurable positive impact
  • During the investigation of major foodborne disease outbreaks by the public health agencies and food regulatory agencies, the NFSRB will have a facilitation and coordination role and will ensure that all critical and relevant data are being shared between the agencies in a timely manner.
  • Within a reasonable period after the acute phase of an outbreak investigation is completed, the NFSRB will conduct a thorough review of the investigation with respect to the performance of the agencies involved. The NFSRB will issue a report within a specified time period indicating what was done right and what could be improved.
  • The NFSRB will work with the federal agencies to make sure that information about the outbreak investigation is released to the interested parties and the general public in a timely manner.
  • The NFSRB will assess the funding needs of the agencies involved in food safety and provide input to the President for the next budget

Obama’s FDA Takes Shape

By Bala Swaminathan, 16 March, 2009, No Comment

Kudos to President Obama for choosing Dr. Margaret Hamburg for Food and Drug Administration Commissioner and Dr. Joshua Sharfstein for Deputy Commissioner. Both candidates have strong public health backgrounds. Hopefully, these new appointments will catalyze the conversion of the FDA from a dysfunctional agency into a revitalized and efficient one.

When will Obama appoint the next director of the Centers for Disease Control and Prevention? For now, it seems Richard Besser is still in charge.

Where Federal Funds Should Go to Avoid Another Outbreak

By Bala Swaminathan, 12 February, 2009, No Comment

It doesn’t look like food safety is going to make it into the economic stimulus bill that President Obama will likely sign before week’s end. As we mentioned earlier, a number of politicians, however, have called for reform. As the United States Congress works to appropriate additional funds to enhance food safety and prevent the recurrence of the peanut butter fiasco, here are a list of priority needs that I wrote up with the help of my friend Craig Hedberg of the University of Minnesota. (I am excited to announce that Craig will soon be contributing to our humble blog.):

1. FDA’s Food Protection Plan is built around the concepts of prevention, intervention and response. Although no amount of inspectors will ever provide an absolute guarantee for the safety of food, more are needed for FDA’s Office of Regulatory Affairs (ORA) in order to ensure that food processing establishments are checked out on a regular basis.  Beyond more inspectors, a broader scope to the inspection process is needed: Regular inspections that were informed by knowledge of the 2007 outbreak of salmonella in peanut butter and included reviews of critical control point-monitoring records and environmental and product test results might have prevented or at least limited the impact of the Peanut Corporation of America outbreak. Interestingly, the ORA website doesn’t express our concern about the need for more inspection resources:

The FDA’s ability to protect the public health has been enhanced by additional resources authorized by Congress in the wake of the Sept. 11, 2001, terrorist attacks. The FDA hired 655 new ORA employees, 600 of whom strengthen food safety, 35 enhance the safety of animal drugs and feed, and 20 are part of the drug, biologic and device programs. About 420 of the new inspectors and other employees either are stationed at border locations or are working specifically on imports. All of the new hires will be trained in both import and domestic operations to help ensure adequate coverage of both domestically manufactured and imported products.

Obviously, that wasn’t enough to conduct inspections of the Peanut Corporation of America’s manufacturing operations.

2. Timely intervention and response requires ongoing surveillance that can identify potential outbreaks early and investigate them rapidly.

a. Because public health surveillance is primarily conducted at the state and local levels, CDC needs funding to enhance epidemiological capacity at state and local health departments. This should be directed to ensure that food history questionnaires will be administered to persons contracting foodborne diseases in a timely manner. The “Team Diarrhea” concept pioneered by the Minnesota Department of Health has proven to be an efficient and cost-effective model for accomplishing this objective. CDC, with assistance and input from the Minnesota Department of Health and University of Minnesota School of Public Health, should use these additional funds to create a series of regional centers for surveillance based on the “Team Diarrhea” model. Standardized questionnaires should be developed to allow for electronic data collection and transmission to a national database that could be linked to PulseNet.

b. Funding for CDC should be increased and directed to assure rapid DNA “fingerprinting” of foodborne disease-causing bacteria and viruses by state and local health departments and timely submission of the DNA “fingerprint” patterns to the national PulseNet database maintained by CDC. CDC and the state and local health departments should be adequately funded so that they can use the best available technologies to obtain the most accurate possible information on disease clusters in a timely manner. States must be encouraged to make appropriate changes to their existing laws to ensure that foodborne pathogen isolates are submitted to the local or state health department as soon as possible for DNA “fingerprinting.”

c. CDC and the state health departments should be provided adequate human resources to conduct frequent and timely review of epidemiological information and PulseNet data to rapidly identify disease clusters and follow up without delays.

CDC Updates Case Count in the Peanut Butter-Associated Salmonella Outbreak

By Bala Swaminathan, 11 February, 2009, No Comment

CDC’s update of February 9 indicates that the case count is now 600 with illnesses connected with the outbreak being reported in 44 states. The onset date of the most recent illness associated with the outbreak was January 23.

Also, CDC has informed me that the PulseNet pattern JPXX01.0459 is indeed a new pattern that was first submitted to the PulseNet National Database in September 2008. (I had previously guessed that it was an old pattern.  Apparently, some of the old pattern numbers assigned by the National PulseNet Database Team are being recycled.)

Why Isn’t Food Safety Part of the Stimulus Bill?

By Nikhil Swaminathan, 11 February, 2009, No Comment

The New York Times reported on the conditions of the Peanut Corporation of America (PCA) plant in Blakely, GA, on Monday. A couple of things are clear from its piece: PCA was not invested enough to make sure they were shipping a safe product, and, perhaps more damning, the state of Georgia was not equipped with the proper personnel to maintain the integrity of its food supply.

“[I]nspection reports on the Peanut Corporation of America plant over the last three years show that state inspectors — Georgia has only 60 agents to monitor 16,000 food-handling businesses — missed major problems that workers say were chronic. … Georgia officials said budget constraints and other outbreaks of food-borne illnesses diminished their abilities to inspect the peanut plants. … Inspecting the plant was the responsibility of Georgia, which like 42 other states is under contract with the Food and Drug Administration to monitor food plants. The agency’s Science Board concluded in 2007 that the agency did not have the capacity to ensure a safe food supply, with domestic businesses under its purview having risen to 65,500 from 51,000 in 2001.”

There is a first step solution to this problem: Hire and train more inspectors and keep them as a continuous presence in a plant.

According to former USDA Undersecretary Richard Raymond (whom I interviewed last year for a Scientific American story that never ran), that agency—which monitors meat and poultry products–has inspectors in slaughterhouses on a daily and continuous basis. The number of inspectors at each plant is proportional to the amount of product made there. Even with this sort of strict oversight, problems—such as the huge ground beef recall of 2007 due to E. coli 0157:H7—still occur. Finding out that the FDA (and its subcontractors) aren’t even getting near this level of oversight is extremely distressing.

Last year, while campaigning, President Obama was one of the legislators calling for reform of our food safety system. “When I am president, it will not be business as usual when it comes to food safety,” he said, according to a recent Times piece. “I will provide additional resources to hire more federal food inspectors.”

Democrats proposed a bill in late January to get food and drug-makers to pay fees to FDA, so that the agency can increase the frequency of inspections. I can just see corporate America loving that.

My solution: Fold money for inspectors on both state and federal levels into the so-called “bloated” stimulus bill being rammed through Congress. Would Republicans have mocked provisions for ensuring the safety of the food supply the way they did condom distribution programs? Probably not. And the inspections wouldn’t cost corporate America a dime—well, except in taxes.

The point of the stimulus bill after all is to create jobs, correct? So, why not kill two birds with one stone? Add provisions to the bill that call for more FDA or state inspectors at everything from facilities that produce dog food to plants that make peanut products. It would create thousands of jobs in mostly rural areas all over the country. And these people will need better training. Who is going to train them? How about a whole new fleet of outreach, education and training workers?

It seems to me that as important as dreaming up the new smart grid, retrofitting buildings and building new roads and bridges is protecting what we eat every day just to live. New legislation regarding how best to deploy these people—by creating a single food safety-devoted agency (rather than the 12 we have now)—is important and certainly necessary. The FDA’s failure in protecting our food supply, however, needs swift correction now. Under its watch, in just the last three years, we’ve seen contamination to spinach, pet food, tomatoes, jalapeñoes, milk products and now peanuts.

The immediate solution to this problem is people–more manpower, more watchful eyes. People cost money. And government seems more than prepared to spend it. So why not on this?

CDC’s Recent Salmonella Report Raises Questions

By Bala Swaminathan, 6 February, 2009, No Comment

On January 29, CDC published a very comprehensive report, which details the various facets of the investigation into the peanut butter outbreak. The latest figures show 550 cases of infections in 43 states; the most recent case developed illness on January 17.

I wish CDC had provided a timeline of the outbreak investigation as they did in the spinach-associated E. coli O157:H7 outbreak in 2006. To that end, I tried to construct a timeline of events from the data provided in the MMWR report. I invite informed readers to bring any mistakes and omissions in the chronology to my attention in the comments section.

Click on image for a larger version.

Click on image for a larger version.

After reading the report, I came up with a list of the following questions and concerns:

  1. The PulseNet network appears to have detected the outbreak at an early stage: when the case count was 13 and it appeared to be a 12-state cluster on November 10. It is interesting that all patients in the disease cluster had been infected with a previously not seen strain of Salmonella Typhimurium that had a unique DNA “fingerprint.” This is much more meaningful than a cluster of 13 case patients infected with a frequently encountered strain of S. Typhimurium.
  2. On November 24, PulseNet reported a second cluster of 27 patients who had been infected with a strain of S. Typhimurium that was closely related to the strain from the first cluster.
  3. By November 25, the number of cases in the first cluster had increased to 35. This is when the CDC OutbreakNet team began an epidemiological investigation with its partners in state and local health departments. My question: Were any patient interviews conducted between November 10 and 25? Were any food exposure questionnaires administered to the cases in the cluster between November 10 and November 25?  Could the lapse of time have contributed to problems with accurate recall of food exposures?
  4. By December 2, the cases in the second cluster had increased from 27 to 41. Additional laboratory characterization of the salmonella isolates from the first and second clusters and epidemiological data from the two clusters indicated that they were part of the same outbreak.
  5. I am struck by the time it took (six to eight weeks, November 10 to December 28, when King Nut came under suspicion, and January 12, when the company’s involvement was confirmed) to identify the source of the outbreak. I wonder if it was because the peanut butter was distributed in bulk packages to institutions such as nursing homes and schools and was NOT sold in retail outlets. Also, it is likely that the epidemiological investigations were confounded because the contaminated peanut butter was used as an ingredient in many different food products that were sold through retail outlets under several different brand names. In any case, it is apparent that the early warning signal provided by the PulseNet network did not prevent a large buildup of cases associated with the outbreak.
  6. This is the third peanut butter-associated outbreak of Salmonella infections that has been recognized and investigated. These include the Australian outbreak of 1996 and the U.S. outbreak of 2006. Interestingly, the serotypes of Salmonella associated with all three outbreaks (Salmonella Mbandaka in 1996, Salmonella Tennessee in 2006 and Salmonella Typhimurium currently) have been isolated from the product implicated in today’s epidemic (more than 2,700 serotypes of Salmonella are known. Typhimuirum is a very commonly encountered serotype; Tennessee and Mbandaka are infrequently isolated). In fact, the exact same strain of S. Tennessee that caused the 2006-2007 outbreak was isolated from a product implicated in the current one.
  7. The low numeric value of DNA “fingerprint” pattern JPXX01.0459 that was isolated from the ill humans and from the implicated product in Connecticut, Michigan and other states indicates that this pattern previously existed in the PulseNet database (pattern numbers are assigned sequentially by CDC PulseNet Database Team in the order in which they are deposited in the database). Since the MMWR report did not elaborate on the significance of JPXX01.0459, I am assuming that this was probably a sporadic case isolate without much clinical/epidemiological information.

Click image for larger version (on CDC site).

Table of salmonella strains associated with outbreak. Click image for larger version (on CDC site).

We will learn a lot more about the outbreak and the investigation of it in the next weeks and months. The finding of multiple, closely related Salmonella Typhimurium strains in ill persons and the implicated product suggests that the parent strain of Salmonella Typhimurium may have been resident in the peanut butter processing facility for some time. If that was the case, why did it not cause illnesses before? What triggered this outbreak? What is the significance of the finding of the salmonella strain from the 2006-2007 outbreak in King Nut peanut butter? Is there a connection between the two outbreaks? I am sure CDC is in hot pursuit of answers to these questions.