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SPECIAL EDITION XI —
Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Senator Harkin Calls For Reform
Of FDA’s Food Safety System

Jim Prevor’s Perishable Pundit, July 17, 2008

Late in the evening on July 15, 2008, we received a nice note from Adela Ramos:

I work for Senator Tom Harkin on the Senate Agriculture Committee and I wanted to make you aware of a letter we sent today on the Salmonella outbreak.

I’ve been reading the Perishable Pundit for some time now, and it’s a great source of information — some of which was used in this letter.

Adela is Senator Harkin’s point person on ag issues, and we are honored to have her readership as well as that of so many other staffers, from both sides of the aisle, in Congress.

The problem at FDA is partly a kind of arrogance. There is not even the pretense made of trying to work together with industry to solve problems, nor any notion that laws might restrain the conduct of FDA executives, so the participation of members of Congress in any attempt to reform the food safety system is vital.

Congress can get answers that the industry simply cannot, and the knowledge that important Congressional leaders such as Senator Harkin are concerned and will be pursuing these matters makes a cover up at FDA less likely. Look at what Senator Harkin had to say:

AS SALMONELLA OUTBREAK GROWS,
HARKIN CALLS ON FDA FOR MORE EFFECTIVE
FOOD SAFETY TRACE-BACK SYSTEM

How Can the Government Tell Consumers
We Don’t Know The Source of What
Made Over 1000 People Sick?

Washington, D.C. — Senator Tom Harkin (D-IA), the Chairman of Senate Committee on Agriculture, Nutrition and Forestry, today called on the Food and Drug Administration (FDA) to initiate an effective trace-back system to allow tracing of the origins of fresh produce in food safety outbreaks. Harkin did so as the Centers for Disease Control and Prevention (CDC) announced this week that since April, 1148 persons have been infected with Salmonella Saintpaul, with cases that have been identified in 42 states, the District of Columbia, and Canada.

In a letter to Health and Human Services Secretary Leavitt, Harkin said that the Salmonella outbreak demonstrates the need for better coordination and communication among federal agencies, industry, and the states, as well as a strong trace-back system to determine the source of food-borne illness outbreaks.

“Each food-borne outbreak seems to be larger than the next, and in this case, over a month has lapsed and the origins of this case are still unknown,” said Harkin. “The victims of this outbreak are growing by the day and don’t know what food made them sick because the source of contamination remains a mystery to the Food and Drug Administration. How do you tell over 1,000 people we don’t know what made them sick?

“In the face of stark warnings about the vulnerability of our food supply, it is time for the government to take action and implement effective trace-back processes so that we can quickly track the origins of contaminated food products in order to prevent increasing cases of illness. It is long past time for the government to take comprehensive steps to increase our response to food-borne illness outbreaks.”

The full text of the letter follows.

July 15, 2008

The Honorable Michael O. Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Secretary Leavitt:

For over a month now, since June 3, 2008, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been communicating to the public and with the fresh produce industry about an extensive outbreak of Salmonella while conducting a trace-back investigation to determine the source of the outbreak. The growing outbreak — with 1,148 persons infected with Salmonella Saintpaul to date and with a growing list of suspected fresh produce items — points to the need for better coordination and communication among federal agencies and departments, and with states and industry. Most importantly, the outbreak once again underscores the need for a tracking and trace-back system that is modern, effective, and protects public health. This outbreak has shown that the systems in place at FDA and CDC to track down the source of a contamination event, regardless of whether the contamination is intentional or not, are woefully inadequate. The Salmonella outbreak also shows that substantive changes are needed in how FDA and CDC communicate with the public and with industry.

I don’t doubt the difficulty of the task or the dedication and hard work of FDA and CDC personnel. There are, however, many questions that need to be answered about this particular investigation, particularly if the source of the contamination is determined to be a product other than tomatoes, the primary suspect in this particular Salmonella outbreak. Both the tomato industry and at least one prominent food safety expert have questioned the slow, cumbersome, and potentially erroneous manner in which FDA has been conducting its trace-back investigation. For example, FDA and CDC have not emphasized comparing the origin of food products consumed by individuals who became ill with Salmonella Saintpaul and the origin of the same type of food products consumed by individuals who have not become ill from Salmonella. This practice of conducting a trace-back investigation of food products consumed by patients who are not sick seems to be one tool commonly used to identify the source of contamination. Why haven’t FDA and CDC employed this strategy during their own outbreak investigation? It seems that the scope of the search could have been narrowed down early by better investigation techniques and had a functional trace-back system been in place.

The inability of FDA and CDC to trace food products from farm to fork has been called into question by the Salmonella outbreak. There should have been a better system in place before this outbreak. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires facilities that manufacture, process, pack, transport, distribute, receive, hold, or import food, except for farms and restaurants, to keep records on the immediate previous source and the immediate subsequent recipients of the food to establish a better trace-back process. The implementation of this Act’s trace-back requirement, as well as the trace-back techniques used in outbreak investigations, needs to be re-evaluated and improved upon in order for the agencies to conduct efficient and adequate trace-back investigations in the future. It is essential FDA move quickly to establish a strong trace-back system using its authority under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and its other authorities. I believe there is adequate existing FDA authority to implement an effective trace-back system. If FDA lacks authority in any respect to achieve this critical objective, Congress must be advised immediately on what is needed.

The events surrounding the Salmonella outbreak demonstrates a startling unfamiliarity with an industry whose safe food production FDA is supposed to oversee. The tomato industry as well as the U.S. Department of Agriculture (USDA) have extensive knowledge and information on harvests, distribution patterns, and retailers that FDA and CDC can tap into in order to speed up trace-back investigations. USDA, the federal department that has the most contact with our nation’s agriculture producers, has been woefully underutilized throughout the entire outbreak process. It has been disturbing to witness FDA and CDC choose not to access this readily-available information from USDA or the tomato industry. This was most apparent by FDA’s compilation of a list of states and foreign countries that were not implicated in producing tomatoes suspected to be the source of the Salmonella outbreak.

If a good share of the tomato supply had been eliminated as a source early on, that would have helped to refocus the search and would have likely sped up solving the mystery, it would have allowed consumers to consume tomatoes and not worry, and would have avoided the enormous losses experienced by tomato growers and distributors. It would seem that FDA and CDC could have easily compiled a list of states and countries where tomatoes were not being harvested at the time of the outbreak. Instead, it was up to all 50 states as well as foreign countries to contact FDA and make a case why they should be on the list of cleared states and foreign countries. Consequently, the process used by FDA to determine which states were not the source of contaminated tomatoes seemed to be a subjective determination based on the ability of the state or country to contact FDA and make the case why that state or foreign country should be declared as a safe tomato-producing region for purposes of the Salmonella outbreak. The manner in which this list was compiled is contrary to a logical investigation where decisions are based on objective information, and where FDA automatically could have ruled out all states that were not harvesting tomatoes during the outbreak.

Another point that highlights the need for better communications from FDA and CDC is the continued warnings against tomato consumption. It seems highly unlikely that tomatoes harvested in April would still be consumed fresh by consumers in late June. It does not make sense why there remains a strong warning against eating certain fresh tomatoes when most states have been cleared by FDA as having produced tomatoes not implicated in the Salmonella outbreak. The warning could be stated in a clearer fashion to assure customers that most tomatoes are safe to eat and are not part of the Salmonella outbreak. FDA and CDC have also failed to clearly inform consumers and retailers that only a fraction of fresh tomatoes were suspect and that many varieties were safe to eat as were all tomatoes from some states. Large restaurant chains, such as McDonald’s, discontinued all tomato purchases needlessly, since there were and still are plenty of tomatoes cleared of any implication of Salmonella contamination. The agencies should have provided clearer information to tomato retailers since some retailers’ complete ban on tomatoes added immensely to consumer misinformation. FDA and CDC should have also provided stronger, publicly-available guidelines to tomato retailers about which tomatoes to sell in order for consumers to know that retailers were not serving tomatoes not approved by the FDA.

FDA and CDC need to take measures immediately to improve their ability to trace-back products and to improve communications with the public and industry. The federal government has been cautioned numerous times in recent years about the potential threats that exist for intentional and non-intentional contamination of the food supply. If we do not have adequate trace-back and communications, the damage to public health and to industry in a future outbreak event can be much more devastating than the current Salmonella outbreak. It is clear that stronger prevention measures of food-borne illness outbreaks are needed, but this particular outbreak shows that our response system is in sore need of improvements as well.

I appreciate your attention to these pressing questions and I look forward to your response.

Sincerely,

Tom Harkin
Chairman

cc: Dr. Andrew von Eschenbach, Commissioner, Food and Drug Administration
Dr. Julie Gerberding, Director, Centers for Disease Control and Prevention
The Honorable Ed Schafer, Secretary, U.S. Department of Agriculture

Senator Harkin deserves every commendation for sending this letter. Iowa is not a major tomato growing state. Sure there are wholesalers, repackers and retailers in Iowa that deal with tomatoes, but still, all Senators are very busy people and the Gentleman from Iowa could have easily elected to sit this one out. That he did not shows a true measure of leadership for which a grateful nation owes its thanks.

Senator Harkin’s letter raises five primary concerns:

  1. The incompetence of the investigation leading to greater public health risk and greater harm to industry. The piece alludes to the interview we published with Michael T. Osterholm, PhD., MPH in which, in another act of leadership, this leading authority on public health spoke up and challenged the actions of CDC and FDA. Specifically Dr. Osterholm attacked the failure to do tracebacks on the control groups.

  2. The whining of FDA about inadequate traceback capability by industry and inadequate FDA authority. Senator Harkin points out that the Bioterrorism Preparedness and Response Act of 2002 already legally requires traceback and traceforward. In other words, which company, precisely, has FDA found that needs to be charged with failure to follow existing law? If no company has been found breaking the law, then what precisely is the traceback problem? Senator Harkin is also very blunt about the FDA’s constant yammering that it needs more authority: “I believe there is adequate existing FDA authority to implement an effective trace-back system.” Of course, Senator Harkin is willing to listen but he is, after all, rather knowledgeable in these areas.

  3. The shocking ignorance of FDA about areas within its jurisdiction and the failure of FDA to access USDA and the industry to help solve the problem. Senator Harkin explains it this way: “The events surrounding the Salmonella outbreak demonstrates a startling unfamiliarity with an industry whose safe food production FDA is supposed to oversee. The tomato industry as well as the U.S. Department of Agriculture (USDA) have extensive knowledge and information on harvests, distribution patterns, and retailers that FDA and CDC can tap into in order to speed up trace-back investigations.”

  4. The odd manner in which a public health agency elected to put together its list of places “not associated” with the outbreak. Senator Harkin explains: “…the process used by FDA to determine which states were not the source of contaminated tomatoes seemed to be a subjective determination based on the ability of the state or country to contact FDA and make the case why that state or foreign country should be declared as a safe tomato producing region for purposes of the Salmonella outbreak. The manner in which this list was compiled is contrary to a logical investigation where decisions are based on objective information…”

  5. Inept public communication. Senator Harkin elaborates in this manner: “It seems highly unlikely that tomatoes harvested in April would still be consumed fresh by consumers in late June. It does not make sense why there remains a strong warning against eating certain fresh tomatoes when most states have been cleared by FDA as having produced tomatoes not implicated in the Salmonella outbreak….”

The points are correct; the only emphasis we might shift is we want to make clear that in communicating to the public about risk, CDC and FDA have an obligation to provide both a numerator and a denominator. To simply say something has “risk” is meaningless in a world where we all gladly drive in cars and fly in planes.

Rather than the FDA feeling itself obligated to make recommendations — which are only driven by the subjective risk tolerance of FDA executives — the FDA should view its role more in an educational sense. What is the risk? What is the risk of eating something else? What is the risk of going to the store to replace your food stocks? Honest discussion of risk, rather than scaremongering over infinitesimal risk, should be the order of the day.

Senator Harkin is much to be thanked. Unfortunately, the influence that the industry might have in DC is pretty heavily invested on the ag side of things and pretty weak on the committees that supervise Health and Human Services. So we depend on people such as Senator Harkin to stand up for us.

Perhaps our favorite line in the whole letter is at the end when Senator Harkin says, “I look forward to your response.”

When Bryan Silbermann of PMA and Tom Stenzel of United Fresh sent their own letter requesting a meeting with Secretary Leavitt, he was in no hurry to respond, so they sent him a second letter.

Of course, Senator Harkin may get a faster response. After all, he has one thing neither Bryan Silbermann nor Tom Stenzel have — a vote on the FDA appropriation.

Many thanks to Adela Ramos for passing this on and a deep appreciation to Senator Harkin for standing up when you didn’t have to.

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