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Perishable Pundit
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Produce Business

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American Food & Ag Exporter

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SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Three Congressional Hearings
Focus On Salmonella Saintpaul

There are three hearings in the House of Representatives this week, all related to the Salmonella Saintpaul outbreak.

The first is focused solely on traceability, the second is dedicated to how the FDA has spent a special supplemental appropriation it had been given, and the third, more generally, to the “lessons learned” for both public health and the industry through this outbreak.

Here are the hearings and the participants:

Wednesday, July 30th — 1:00 p.m.
1300 Longworth House Office Building
Subcommittee on Horticulture and Organic Agriculture — Public Hearing.
RE: To review legal and technological capacity for full traceability in fresh produce.


WITNESS LIST:

Panel I

The Honorable Diana DeGette, Member of Congress from the First Congressional District of Colorado

Honorable Adam Putnam, Member of Congress from the Twelfth Congressional District of Florida

Panel II

Dr. David W.K. Acheson, M.D., Associate Commissioner for Food Protection, U.S. Food and Drug Administration, Rockville, Maryland

Dr. Lonnie J. King, Director, DVM, National Center for Zoonotic, Vector-Borne, and Enteric Diseases (ZVED), Center for Disease Control, Atlanta, Georgia

Panel III

Mr. Anthony J. DiMare, Vice President, DiMare Homestead Inc., DiMare Ruskin Inc., and DiMare Johns Island Inc., Ruskin, Florida

Mr. Henry L. Giclas, Vice President, Strategic Planning, Science and Technology, Western Growers Association, Irvine, California

Mr. Bryan Silbermann, President, Produce Marketing Association, Newark, Delaware

Mr. Thomas E. Stenzel, President and CEO, United Fresh Produce Association, Washington, DC

Panel IV

Dr. James R. Gorny, Ph.D., Executive Director, Postharvest Technology Research and Information Center, University of California, Davis, California

Ms. Jean Halloran, Director, Food Policy Initiatives, Consumers Union, Yonkers, New York

Dr. Michael Osterholm, Director, Center for Infectious Disease Research and Policy, University of Minnesota, Minneapolis, Minnesota

— — — — — — — — — — — — — — — — — — — — — — — — — — — — —

Wednesday, July 30th — 1:30pm
House Appropriations Subcommittee on Agriculture
1:30pm, 2362-A Rayburn House Office Building
Washington, D.C. 20515
202-225-2638

WITNESS LIST:

Stephen Sundlof — FDA’s Food Center Director

Michael Taylor — Research Professor of Health Policy at George Washington University

Jeffrey Levi PhD — Executive Director of Trust For America’s Health

Gibb Patrick — Farmer, representing Georgia tomato growers

— — — — — — — — — — — — — — — — — — — — — — — — — — — — -

Thursday, July 31, 2008
U.S. House of Representatives
Committee on Energy and Commerce
Subcommittee on Oversight and Investigations

10:00 AM in room 2123 Rayburn House Office Building
“The Recent Salmonella Outbreak: Lessons Learned and Consequences to Industry and Public Health”

WITNESS LIST:

Panel I

Mr Ed Beckman
President
California Tomato Farmers
Fresno, California

Mr. Parker Booth
President
Ace Tomato Co., Inc.
Manteca, California

The Honorable Charles H. Bronson
Commissioner of Agriculture and
Consumer Services
State of Florida
Tallahassee, Florida

Mr. Reginald L. Brown
Executive Vice President
Florida Tomato Growers Exchange
Maitland, Florida

The Honorable A.G. Kawamura
Secretary
Department of Food and Agriculture
State of California
Sacramento, California

Mr. William Hubbard
Senior Advisor
Coalition for a Stronger FDA
Chapel Hill, North Carolina

Panel II

Lonnie J. King, D.V.M.
Director
National Center for Zoonotic,
Vector-Borne and Enteric Diseases
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Atlanta, Georgia

Timothy Jones, M.D.
State Epidemiologist
Communicable and Environmental
Diseases Services
Department of Health
State of Tennessee
Nashville, Tennessee

David W.K. Acheson, M.D.
Assistant Commissioner for Food Protection
Food and Drug Administration
U.S. Department of Health and
Human Services
Rockville, Maryland

Kirk Smith, D.V.M., PhD.
Supervisor
Foodborne, Vectorborne, and Zoonotic
Disease Unit
Acute Disease Investigation
and Control Section
Department of Health
State of Minnesota
St Paul, Minnesota

Panel III

Shaun Kennedy, PhD.
Director
National Center for Food Protction
and Defense
The University of Minnesota
St. Paul, Minnesota

Michael R. Taylor, J.D.
Research Professor of Health Policy
The George Washington University
School of Public Health and Health Services
Washington, D.C.

Mr. Hank Giclas
Vice President
Strategic Planning, Science & Twchnology
Western Growers Association
Irvine, California Association
Washington, D.C.

Donna Garren, Ph.D.
Vice President, Health and Safety
Regulatory Affairs
National Resturant
Washington, D.C.

Mr. Thomas E. Stenzel
President and Chief Executive Officer
United Fresh Produce Association
Washington, D.C.

Robert E. Brackett, Ph.D.
Senior Vice President and Chief Science
and Regulatory Affairs Officer
Grocery Manufacturers Association
Washington, D.c.

We are pleased to see the witness list filled with many who have had their views on this matter brought to public attention through the Pundit.

We sincerely hope that the important issues raised during this outbreak will be dealt with effectively and that progress will be made so that consumers can have even safer food, the industry will be able to grow and prosper, and the public health infrastructure will be stronger and more purposeful.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Congressional Hearings
Should Pave Path For Public Health

What is a reasonable position for the industry to take in the upcoming Congressional hearings? We have to start with the realization that any proposal must, above all, enhance public health. A plea to help the produce industry will seem self-interested and is unlikely to sway many votes in Congress.

It is also true that the industry must be honest about the vulnerabilities of fresh produce, and that the trade must ask Congress for guidance when the issue switches to the public policy arena.

In the July 2008 issue of PRODUCE BUSINESS, the Pundit wrote a column entitled, The Courage of our Convictions, in which we laid out 10 points the industry should make in speaking to Congress:

1) We recognize that in electing to sell processed product with a representation to consumers to eat without washing, members of the trade take on the role of food processors and ought to be subject to the rules other processors must conform to.

2) We acknowledge that raw produce can pose special risk for those with immature or compromised immune systems. We have adjusted our Web sites and those of industry promotional organizations and, when product is packaged, we have adjusted the packaging to reflect this message.

3) We are committed to delivering safe food. It must be noted, however, that just as cars are generally “safe” and airplanes are generally “safe” — nobody interprets this to mean that there will be no auto accidents or plane crashes — so, the fact that fresh produce is generally “safe” does not mean that nobody can or will get sick from eating fresh produce.

4) We grow fresh produce, generally, in soil; it is exposed to rain and wind, to animals and people. It is the natural state of such a product to occasionally contain pathogens that can make people sick. Much, but not all, of this risk can be avoided by consumers and restaurants playing their part in food safety and carefully washing all produce. In any case, the risk of illness, especially serious illness with long-term effects, is very small.

5) Scientific efforts to advance food safety continue and the industry supports such science financially. We encourage the government to accelerate progress in this area with additional financing.

6) With current science, each enhancement of food safety increases the cost of the product. So we can put animal traps at every 100 feet or every five feet or anywhere in between. Each step is believed to enhance safety, but each step costs money. There is no correct food-safety answer. It is a political decision how much society is willing to increase the cost of these foods in exchange for higher levels of safety, just as it is a political decision to what extent cars should have 15-mph bumpers or 25-mph bumpers.

7) It is the responsibility of Congress and the FDA to express that political choice through laws and regulations. Just as the law may require a 15-mph bumper, so the law for the produce industry may require set buffer zones, soil amendments, etc.

8) The FDA, working with state departments of agriculture, its own personnel or third-party auditors, shall define a regimen of inspection and testing that suppliers can follow to be certified as compliant with food-safety laws and regulations.

9) It shall be the option of the government to decide if non-compliant companies can continue to produce and market product.

10) Farms and other production facilities certified as compliant shall be presumed to be producing safe food unless specific evidence implicates a particular farm or facility. In the absence of specific evidence, they shall be exempt from any “recalls,” “recommendations not to consume” or other health messaging.

Basically, the situation is two-fold: First, since there is no right or wrong answer as to how often water should be tested or how closely traps should be laid in the field, these are now social questions that require social answers. Second, FDA needs a way to know who the “gold standard” producers are so that in its response to an outbreak, the FDA does not divert business from such gold standard producers to those utilizing less effective food safety systems.

This 10-point proposal states the facts plainly and provides a path for public health to be enhanced while ending the damage caused to the industry by widespread bans on different produce types.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Recommendations, Information
And Public Health

The proposal to impose federal regulation on the industry is unobjectionable to most — at least in those commodities where there is known risk. If the government regulates fresh herbs, green onions, cantaloupes, leafy greens and tomatoes… and if the regulation is effective… it will at least eliminate the issue of sub-standard operations endangering public health and harming the whole industry.

What it is not likely to do is change the way the FDA reacts when there is an outbreak. And that is a big problem.

An effective national food safety policy has to include both a plan to prevent food safety problems and a method for dealing with them when they do arise.

The FDA is wearing blinders here because they feel a need to “recommend” courses of action — don’t eat spinach, don’t eat tomatoes, don’t eat peppers — as opposed to feeling an obligation to inform.

This is a dilemma which Congress really should clarify.

The National Highway Traffic Safety Administration, for example, publishes copious information to help consumers evaluate the safety of cars. It has a web site — Safercar.gov — that includes driving tips, advises people about defects and recalls and allows people to search for a “star rating” of safety on various attributes. Here is a sample page for SUVs.

What the NHTSA does not do is issue recommendations as to whether people should drive or not, leaving individuals to judge the risk/reward ratio of the behavior.

The FAA works diligently to protect the safety of air transportation. Way back in the spinach crisis, we ran a piece excerpted from the FAA’s website to show how it discussed safety:

The goal for the end of the fiscal year is a three-year rolling average of 0.018 fatal accidents per 100,000 departures. Through March of this year, the aviation industry has maintained a rate of 0.022 fatal accidents per 100,000 departures. There have been three fatal air carrier accidents this fiscal year… The FAA continues its work that has resulted in the almost continuous long-term reduction of the commercial air carrier fatal accident rate.

What the FAA does not do is go around issuing recommendations as to whether .018 fatal accidents per 100,000 departures is something an individual should accept or not.

A serious foodborne illness caused by fresh produce is an exceedingly rare event. This means that it is very difficult to increase an individual’s personal safety through a consumption restriction on fresh produce. Look at the numbers for this very large and serious outbreak related to Salmonella Saintpaul.

The CDC estimates that there are 76 million cases of foodborne illness in the US each year. With 1,307 known ill, and if we multiply each by 30 people to adjust for under reporting, we have an enormous outbreak of 39,210 people. Fortunately most not ill enough do not go to a hospital. Since the outbreak is still ongoing, let us assume the total illnesses will wind up being 50,000 people sick.

This is, of course, terrible, yet even an outbreak of this unprecedented scale poses little risk.

With about 305 million Americans and 76 million foodborne illnesses, there is a 24.918% chance that an American will get a foodborne illness during the course of a year. This number includes outbreaks.

So if we had perfect foresight and could have avoided this outbreak entirely, how much would Americans have benefited? Well, then the math would be that there would be 75,950,000 foodborne illnesses this year. Divided by 305 million people and the risk of getting a foodborne illness would have been reduced to 24.916% — a difference of .002%.

Of course most people take lots of risks that could cause them to get a stomach ache — eating from street vendors, etc. So they are more likely to be concerned about serious illnesses such as would require hospitalization.

The CDC currently estimates that there are 325,000 hospitalizations each year due to foodborne illnesses. Yet this enormous outbreak has generated only 253.

With 325,000 hospitalizations and 305 million people, the risk of an American being hospitalized in a year due to a foodborne illness is only .1066%, and if we knew about this Salmonella Saintpaul outbreak in advance and prevented anyone from eating these products, the risk would be 324,747 hospitalizations per year with 305 million people or .1065% risk of hospitalization — a difference of .0001%.

Now in reality these numbers substantially overstate the benefit of any public health recommendation as they assume that the government knows about the outbreak before it starts. More realistically, if the outbreak is half over before the government would identify the outbreak, determine its cause and issue a recommendation, the public health benefit of FDA recommendations would be only half the very small numbers listed above.

In America, we believe in freedom and consumers having the right to make choices for themselves.

If an FDA recommendation was just that — a suggestion — it might not pose a problem, but because virtually all reputable chains, both retail and foodservice, will not sell product that FDA recommends people not eat, an FDA recommendation not to consume functions as a de facto recall.

Because the FDA recommendation is so powerful with the trade, yet the public health benefits are so small, down to the third and fourth decimal place, FDA should avoid issuing recommendations when the impact on public health is so small.

Basically all people take risks every day and to “recommend” that consumers not eat or do something because it has an effect on risk down to the third or fourth decimal place is simply to impose a conservative risk aversion profile that may or may not be in accordance with the way individuals would elect to live their lives.

As such, FDA should abandon this policy of making these broad recommendations not to consume. Instead, as with the NHTSA, FDA should publicize what information it has, being careful, of course, to put it in perspective.

There are two separate problems that Congress will be dealing with: The first is how to improve food safety on fresh produce — for that we have recommended a certification program to ensure farms operate to a gold standard. The second is how FDA should conduct itself to enhance public health without bankrupting industries so they can’t afford to invest in food safety.

The answer is for Congress to direct FDA to function in an educational fashion on foodborne illness outbreaks unless there is a particular reason to fear high numbers of fatalities or permanent damage.

This preserves the interests public health authorities have in disseminating important information, it helps avoid panic among consumers by putting information in perspective, and it avoids a disastrous impact on food producers by preserving consumer freedom.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Reasonable Suggestions For
FDA And Industry Methodology

Several Congressional hearings will be held this week related to the Salmonella Saintpaul outbreak. The hearings will focus on various things — trace back, how the FDA has spent a supplemental appropriation, the current state of food safety in the produce industry, etc.

An important subtext of the hearings, though, is to attempt an analysis of what is wrong with the way FDA handles food safety issues and, as a consequence, how we can do it better.

One of the more sensible approaches to this issue was developed by Robert A LaBudde, PhD, PAS, Dpl. ACAFS, of Least Cost Formulations Ltd., which specializes in the development of productivity-improvement techniques and management-decision support systems, especially for the food blending industry:

Any study of control theory knows that a process control system requires the following steps:

1. Measure the output.

2. Have targets (aka standards) for the output.

3. Compare the measurement to the targets to determine the direction and size of the correction needed.

4. Have a predetermined plan of action.

5. Select and implement the action (correction), based upon the comparison.

In the produce area, here tomatoes, FDA fails completely on each of these steps. They don’t measure the Salmonella contamination of tomatoes on a regular basis to say what the incidence rate is. They don’t have rational targets desired, other than zero tolerance. They have no plan of action, other than shutting down the entire industry.

FDA and USDA would both prefer “risk-based inspection”, which is bureaucratese for “cut measurement even further”. The “risk” is not a measured, empirical risk, but instead some hypothetical, static risk ascertained in some one-time theoretical study. Real “risk-based inspection” would make measurements of actual incidence, and allocate resources to reduce that incidence. Instead, resources are allocated based upon hypothetical behavior patterns with presumed association with incidence.

What should the FDA be doing?

1. Require the industry to conduct self-inspection of pathogen incidence of outgoing product. Although this would not be at a sufficient level to supply much confidence in a particular lot, over time it would provide confidence in the system, and a measurement of incidence rate with confidence interval.

As I have mentioned before, even a single sample tested once each week, with a composite made of all production for that week, would be sufficient to provide steering information and provide some confidence operations are not completely in shambles.

2. Use intensified inspection when an outbreak is occurring to discover which producers have degraded performance relative to their former baseline.

3. Allow producers to use intensive inspection results to “get out of the box” with respect to retainage when the source of an outbreak is not yet identified.

4. Allow lot-based inspection to provide assurance that particular production is free of contamination at some rational level.

Experience shows that, when an outbreak level of contamination is present in operations, contamination is pervasive and easy to detect.

Having 60 random samples for one lot or period of production test negative at 1 CFU/25 g would provide good assurance that this production is not capable of producing an outbreak.

5. Maintain traceback capability for samples taken in distribution.

Lots should be marked with a unique producer ID.

Currently FDA has no plan other than to bring an entire industry to a stop. It has no good way to identify source, and no good way to clear producers. This is about as unscientific as it is possible to be, and is an absurd method of regulation.

If FDA’s sole goal is to punish the industry into policing itself, I suppose this plan works for this purpose. If it is to maintain a safe food supply and rapidly identify a source of outbreaks, it is sadly lacking.

If FDA plans to punish industry into self-regulation, it would do better to activate the franchise and retail chains who are industry’s customers. They are much better at creating and enforcing safety regulations than FDA ever could be.

— Robert A. LaBudde, PhD, PAS, Dpl. ACAFS
Least Cost Formulations, Ltd.
Virginia Beach, Virginia

Dr. LaBudde’s plan speaks to many of the problems and provides reasonable solutions. Two key points:

  • Instead of saying that only zero incidence of a pathogen is acceptable, Dr. LaBudde urges a scientific approach to ascertain what the baseline level of contamination is. Once that level is determined — perhaps through required self-inspection of pathogen incidence — targets could be developed to reduce that incidence over time.

  • In the event of an outbreak where the source has not been determined, producers could use intensive inspection to “get out of the box” or be free of an FDA restriction.

This analysis also points to a different way of looking at testing. We ran a piece entitled, A Closer Look At Finished Product Testing, and wrestled with the issue of what role testing should play in light of the fact that it was not financially feasible to do enough finished product testing to statistically validate safety.

Here, however, low levels of testing are being suggested to ascertain an industry baseline and then short term, intense testing to clarify issues and free up product in an outbreak would be followed.

There are many valid suggestions of things that can be done to reform the way produce and the public health systems intersect. Many thanks to Robert A. LaBudde for presenting such a sensible approach.




State Health Departments Need
Increased Level Of Competence

Without a doubt the most prescient person in this whole Salmonella Saintpaul outbreak is Jim Gorny at UC Davis. At an early stage in the outbreak, he wrote a piece for us which we published under the title, Tomato/Salmonella Situation Cries For Improved Epidemiology.

Dr. Gorny foresaw that the focus would move quickly to traceback, although the real problem was epidemiology:

Since September 2006, many persons have advocated for expenditure of more resources to enhance produce traceability, as they believe that enhanced traceability is the most effective means of avoiding the complete shutdown of a produce industry sector. Well, it has happened again and traceability was never the cause of these industrywide shut downs, and it is unlikely that enhanced traceability will ever prevent a future industrywide shutdown.

…painstakingly slow epidemiological investigations carried out by local, state and federal public health officials are the real cause of these industrywide shutdowns.

Dr. Gorny also cautioned about how sloppy epidemiology up front could cause massive delay:

Importantly, epidemiologists investigating the foodborne illness outbreak must be EXTREMELY careful in assuring that the link between what ill persons ate and where they purchased that food item is factually correct. If a false assumption is made early in the investigative process (i.e., wrong food product or wrong point of purchase), it leads the epidemiological investigation down the wrong distribution chain, thus wasting time, resources and ultimately delaying the identification of the true cause of the illnesses.

There has been much talk of creating one food safety agency on the federal level and, very possibly, that might help. In fact, we don’t know anyone who is opposed to it conceptually, the sticking point being whether the one federal food safety agency should be located in USDA or HHS.

Yet one of the key lessons in this outbreak has been how incompetence and lack of resources on the state level quickly become a national problem.

If Congress really wants to do something useful, it would be to launch a national initiative to bring all state health departments up to the level of top ones such as Minnesota. We would suggest retaining Michael T. Osterholm, who built the Minnesota operation and with whom we spoke frankly about this Salmonella Saintpaul outbreak in an interview we entitled, Dr. Michael Osterholm, Esteemed Authority On Public Health, Speaks Frankly About The FDA, The CDC And The Incompetent Management of the Salmonella Saintpaul Tomato Outbreak Investigation to head up this effort.

Here is how Dr. Gorny explained the situation:

The real issue regarding industrywide shutdowns is not about produce traceability (although good traceability does help), but it is about epidemiological investigations that are slow, laborious, time-consuming and resource-intensive affairs. Because multiple federal, state and local public health authorities must collaborate in these investigations, it increases the complexity of the task. This is not a criticism of public health officials trying to protect public health but merely a statement of facts regarding these investigations.

Public health agencies are currently fragmented and under-resourced to effectively monitor and respond rapidly to developing public health issues. Why did it take upwards of 6 weeks for public health officials to identify this cluster of illnesses… and then only due to the diligence of state public health officials in New Mexico?

Food industry, government and the public should be concerned about this lagging response time and its subsequent effects on public health and commerce. Since September 2006, each and every foodborne illness outbreak investigation should have been viewed as an opportunity to enhance investigation team response times to assure public health and well being. Simply put, more public health resources are needed to adequately protect public health and commerce in a timely manner or we will continue to see industrywide shutdowns in the produce industry.

Traceback is inherently limited as you can’t trace back what epidemiology has not identified as the cause. So even perfect traceback will not find you a jalapeno if epidemiology says the problem is tomatoes.

Dr. Gorny was early and he was right: Getting the epidemiology right and fast is the place for public policy to focus.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

All In Favor Of Regulation Say ‘Aye’

The industry is all set to practically demand regulation in Washington, DC. This may be a wise policy.

It is a weakness of democratic politics that people are prone to believe that passing a law against something will accomplish something. So just as it was once believed that the Kellogg-Briand Pact, also known as the Pact of Paris, would end all war, people believe that a law banning unsafe produce will end foodborne illness outbreaks.

The Kellogg-Briand Pact was a treaty — still binding in fact — “providing for the renunciation of war as an instrument of national policy.” Alas, this 1928 agreement signed by Germany, Italy, Japan, the UK, the USA, France, Russia, Poland and many other countries, did not prevent World War II or any of the wars since.

Ceremony held upon the signing of the Kellogg-Briand Pact

There is actually a very strong argument to be made that the most effective food safety system is no system at all. If the government would actually announce a policy of caveat emptor and tell buyers they are on their own — that the government makes no effort to secure safe produce — the immediate effect would be to raise the value of brands.

Consumers — as well as trade buyers — would pay a premium to buy brands that they felt were safe. This premium would justify investments in food safety that would advance the technology.

Regulation may well raise minimum standards, but it provides no incentives for going beyond the minimum.

We explained the dynamics of this in a column in Pundit sister publication, PRODUCE BUSINESS, entitled The Economics of Mandatory Regulation.

The effort before Congress, though, is not so much designed to increase food safety as to increase public and regulatory confidence. There is some irony in the idea that by begging for regulation the industry can appear to be safer, while rigorous competition to be seen as safer might actually cost the industry a lot more money.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

PMA’s Town Hall Meeting
On Salmonella Saintpaul
Raised More Questions Than Answers

At its annual Foodservice Conference, PMA conducted a “town hall meeting” on the Salmonella Saintpaul crisis. Facilitated by Bryan Silbermann, President of PMA, on the stage was a large panel made up of a PMA executive, an FDA official, one domestic tomato grower, a Mexican tomato grower, two regional tomato associations, an executive from the California Leafy Greens Board and Sam Farr, the Congressman from Monterey County.

One always learns something from events such as this, but, fundamentally, these large panels are simply not the way to extract much in the way of information. Years of interviewing have taught us that only the ability to ask pointed follow-up questions enables one to get people to speak on subjects they are hesitant to speak about.

Each person is too involved, has too many reasons to be quiet and because there are so many panelists and everyone has to get a chance to speak, it is too easy for a panelist to dodge a question.

Something more along the lines of “Meet The Press,” where one person is interviewed for an hour by someone knowledgeable enough to not let them get off with platitudes would generate more valuable information for the industry.

As it was, the presentation raised many interesting points, but left most of them dangling because nobody was there to ask pointed questions.

Bryan Silbermann started the session off by pointing out that it was easier to attack and criticize than to productively identify solutions — a claim that is undoubtedly true. Yet, if the critique of FDA and CDC is thoughtful, such analysis is truly valuable. In fact, it is a prerequisite to finding solutions. After all, if we can’t identify what went wrong in the conduct of this outbreak investigation, how will we possibly know what we want to do differently in the future?

The truth is that it would be extremely helpful to have PMA’s critique of CDC, FDA, the State Health departments, etc.

Kathy Means, PMA’s Vice President of Government Relations, kept emphasizing the point that although the tomato farmers on the stage had been able to conduct quick tracebacks, this didn’t mean everyone could do so. Undeniably true. Yet Kathy did not say that, in fact, this particular outbreak investigation had been slowed down by tomato shippers who couldn’t track back quickly, leaving us to see this as a purely theoretical concern.

Scott Horsfall pointed out that the California Leafy Greens Marketing Agreement, which was the industry’s primary response to the spinach crisis, was up and operating and being duplicated in other states. So far so good in terms of no major outbreaks, but he didn’t address the major questions surrounding the Marketing Agreement: What would happen if a major player pulled out? With the growth in local processing, are standards being duplicated everywhere? Even in California, the Marketing Agreement doesn’t have 100% membership — what would happen to the industry if a non-member had a food safety problem? What is private testing telling us about the prevalence of E. coli 0157:H7, Salmonella and other pathogens on leafy greens? Do regulators respect the program, and would they react differently to an outbreak today because of the program?

Scott Horsfall, Parker Booth, Reggie Brown, Ed Beckman,
Martín Ley, Sam Farr and Sherri McGarry

Parker Booth, President of Ace Tomato and Delta repack Company, reported that in a recent test with Congressional investigators, his traceback systems worked very well and he echoed a Pundit beef that by treating all suppliers alike — whether they had invested heavily in food safety or not — FDA depreciates the value of investing in food safety.

He also pointed out, as we have emphasized many times, that by disrupting the aligned supply chains of food safety-conscious buyers, the FDA was forcing these buyers to turn to unvetted sources and thus increasing food safety risks rather than reducing them.

Both Reggie Brown, manager of the Florida Tomato Committee and Executive Vice President of the Florida Tomato Exchange, and Ed Beckman, President or the California Tomato Farmers, complained about the consumer media coverage.

They were too polite to point out that for the most part the media coverage is an echo chamber of the official government pronouncements. So if Dr. Acheson goes before the national media and says the problem is that the tomato farmers keep all their records with pencil and paper, then the consumer media will report about a very unsophisticated industry with poor traceback. The root cause of the problem, though, is not the reporters but what the FDA is saying.

Ed Beckman, Martín Ley, Sam Farr, Sherri McGarry

Martín Ley, Vice President of Del Campo Supreme, pointed to the overly broad nature of the FDA’s restrictions, comparing it to FDA recommending against drinking water because one bottled water manufacturer had a faulty product.

Congressman Sam Farr (D–Carmel) pointed to the predisposition of public health authorities to err on the side of caution. But in response to a question, he did acknowledge that society had come to accept, in the case of automobile accidents, that safety was just one of many values. He clearly was looking for ways in which Congress could be helpful but didn’t proclaim any particular legislative initiatives.

Sherri McGarry, Emergency Coordinator for FDA’s Center for Food Safety and Applied Nutrition, was clearly the most underutilized member of the panel. She made a vague statement that the FDA’s definition of traceback differs from what the industry defines as traceback, but she didn’t explain what the FDA wanted to see.

She wasn’t prompted to explain any of the FDA’s or CDC’s actions and her statements that echoed FDA policy were not critiqued. In other words, there was no mechanism on the panel to question… nobody to say or point out the critique that Dr. Michael T. Osterholm made of the initial epidemiological effort here… and ask FDA to respond to that critique.

One thing that did come out of the session was that FDA is making greater efforts to engage with the industry. Unfortunately some of this engagement sounded like ex parte communication with selected industry groups.

To many industry leaders, this communication is highly questionable. After the session, we received several calls from importers and producers of tomatoes from Baja bitterly complaining about the communication the FDA had with the regional US tomato organizations — pointing out that these regional organizations were competitors and couldn’t be expected to protect the interests of Baja or other producing areas.

Several saw in those communications a process that led to Baja being thrown under the bus in the early days of the outbreak, while both California and northern Florida had an exemption.

We think these suppliers have a strong point. It is one thing to turn to industry on a broad, national basis and get together a group of experts not involved in the controversy to give advice and lend expertise. It is quite another thing entirely to go to individual organizations that have a specific dog in the fight and let them influence policy.

Many thanks to PMA for sponsoring and facilitating the session.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Will Colorado Salmonella Sickness Case Lead To Texas Pepper?

High profile food safety attorney Bill Marler has sent along word that one of his clients was the first person to fall ill of Salmonella Saintpaul after having eaten jalapenos. This person actually had jalapenos left over from his purchase and the jalapenos and the client’s illness were a genetic match — two enzymes — for Salmonella Saintpaul. In addition, the tainted peppers were purchased at a local Wal-Mart.

We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Alicia Cronquist
Epidemiologist
Colorado Department of Public Health and Environment

Q: I’m told you were integrally involved in the epidemiological study linking a human case of Salmonella Saintpaul from jalapenos. How did it unfold?

A: It was a team effort. Let me start by talking generally, rather than about this individual case. Salmonella is a reportable condition in Colorado. When someone is diagnosed with salmonella, the lab and health care provider must report it to the health department, local or state in our case. The average time is about five days from the sample to the reporting.

We hear someone is ill with Salmonella. We call and ask them what they ate, when, where, etc.

Q: As far as a time line, your state release says the pepper was purchased at a local Wal-Mart, likely on June 24, and the individual became ill on July 4.

A: In this instance, we learned the individual had leftover peppers in his refrigerator and we arranged to have them shipped to a lab and tested them. I’m not sure of the exact date when the lab received them; it was sometime last week. The state lab did the culture, grew the bacteria and then did additional testing to determine if it was the same strain that made people ill in the outbreak. Those results were final on Monday, July 28.

Q: How many peppers did the individual have in his refrigerator? How many were tested in the lab? Were they tested separately or was it a composite? There have been many references to “the pepper” and a single pepper, first by FDA’s Dr. Acheson in regards to the pepper sample that tested positive from the Agricola Zaragoza produce distributor, and now in the Colorado release.

A: I don’t have details of the FDA tested pepper sample. In Colorado, the individual had two peppers left in the fridge. We obtained both. They arrived in the same box, shipped from the patient, and both were tested together. There was no separation because they were sitting together in the box. It wasn’t a whole group of peppers tested. There were just the two in the fridge.

Q: In a wide spread outbreak, couldn’t you have sick people touching and contaminating produce, in turn falsely implicating that produce? Hypothetically, the Colorado individual could have contracted Salmonella Saintpaul eating salsa at a restaurant, and then upon hearing news of the outbreak remembered he had peppers in his refrigerator, picking them up and in the process and contaminating them. Is that possible?

A: It’s possible, but highly unlikely. There is pretty good evidence the pepper is the likely source of the illness. When people get ill, they do shed it in their stool — the bacteria is in your feces. At some point, it came from some animal. It’s impossible to know.

We conducted a lengthy interview. We have all different types of investigating methods for ill patients. If we have a group of people sick, we try to interview both sick and well people. Other times, in nationwide outbreaks like this Salmonella Saintpaul, we pull all states and interview controls on a national level. So Colorado did participate in that.

Q: Are you involved in the trace back investigation of the Colorado case? How far along is the state on the trace back? Wal-Mart, where the patient purchased the peppers that tested positive for the Saintpaul strain, has a dedicated distribution center system. This usually means there is only one supplier to a given distribution center. Then you would need to trace back from there to the actual farm…

A: The state health department is working with the government. The trace back is ongoing. Trace back activities are underway. When we have more information, the state will probably issue another release, which I’ll arrange to have sent to you. In the mean time, feel free to check back with me.

Q: The significance of this finding seems to depend in part on the trace back investigation. For example, if the positive pepper in Colorado and the positive pepper in Texas both link back to that same Mexican farm, versus the pepper in Colorado tracing back to a completely unrelated location and origin.

A: The important thing is Salmonella doesn’t belong on produce. FDA works really hard to make sure there is no Salmonella in produce at all. I do think this is an important step in the investigation — the first time linking a specific pepper to a specific person that has been ill with the same DNA fingerprint of the Saintpaul outbreak.

There is pretty good evidence that jalapeno pepper is the likely source of this Colorado patient’s illness. After all, 1,300 people getting ill from this same strain is extremely unusual. This is a large outbreak.

Q: When states report test results, CDC says there is a process that takes place to determine whether it accepts that certification. How does that work? Does CDC have to do a separate confirmation test? Is there any possibility that CDC would not accept this testing?

A: This relates to DNA fingerprinting — pulsed field gel electrophoresis, the official term. People at CDC can better describe the process. There is a nationwide data base called Pulsenet. Our molecular scientists at each laboratory do tests and post an electronic image on a web board. CDC checks and determines whether they agree with the markings. This is a process used very successfully for over 10 years.

Q: Has CDC checked Colorado’s results yet?

A: It’s complete. CDC has confirmed Colorado’s lab results. We are very confident the isolate we have from this pepper matches that of the nationwide outbreak.

What we don’t know now:

  1. Did the pepper give Salmonella to the ill person or did the ill person pick up the illness elsewhere — say a restaurant — and contaminate the pepper?
  2. Does the strain match that found in the warehouse in Texas?
  3. Will the traceback lead to the warehouse in Texas?
  4. Will the traceback of the Texas and Colorado peppers lead to a common farm?

If there is a match between the Salmonella Saintpaul on the pepper in Colorado and the one in Texas and the peppers have a common origin, the odds become overwhelming that we have found the source. If, and it is a big if, there was only one source.

Many thanks to Alicia Cronquist and the Colorado Department of Public Health and Environment for helping the industry to better understand the findings in Colorado.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Resource Guide On Food Safety

With the House of Representatives hearings going hot and heavy this week, we have been getting a lot of calls looking for resources. We wanted to remind readers that we maintain a variety of “Hot Topics” buttons to allow you to review and update yourself on many subjects.

For example, related to food safety, on the left side of this page you will find buttons related to this Samonella Saintpaul outbreak as well as one dedicated to the recent FDA Import Alert on a producer of Honduran Cantaloupe. You can also get background from our Hot Topic button on the 2006 Spinach crisis and the Buyer-Led Food Safety Initiative that grew out of that crisis.

We also have an interesting series of interviews with foodservice operators analyzing the concept of an aligned supply chain. Buttons on Botulism and Carrot Juice, the National Restaurant Association’s Efforts and an initiative by the Food Safety Leadership Council round out these offerings.

We would also highlight four articles that have been seminal in analyzing this Saintpaul Salmonella crisis:

The first is from a distinguished epidemiologist who spoke out early against the incompetence of the investigation:

Dr. Michael Osterholm, Esteemed Authority On Public Health, Speaks Frankly About The FDA, The CDC And The Incompetent Management of the Salmonella Saintpaul Tomato Outbreak Investigation

The second is from a PhD at UC Davis, who said early on that the problem was going to be epidemiology, not traceback:

Tomato/Salmonella Situation Cries For Improved Epidemiology

Third was actually written in relation to the Honduras cantaloupe situation, but illustrates the FDA’s essentially lawless behavior:

Fix Suggested For FDA’s Vigilante System Of Banning Product Through Import Alerts

The fourth and final piece is with an eminent legal scholar who deals with the difficulties of getting compensation:

With FDA/CDC Protected By Sovereign Immunity, Compensation For Losses Looks Bleak Says Professor Richard Epstein

If you are looking for information we have not yet provided, let us know and we will certainly try to help.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Pundit’s Mailbag — Free Baja Take 2

When the focus of the Salmonella Saintpaul outbreak was tomatoes, we ran two pieces related to Baja. The first was entitled, Free Baja, and urged the FDA to add Baja to the “safe list” since the same logic that applied to northern Florida applied to Baja.

The other piece was entitled, Andrew & Williamson Hit Hard By FDA’s Mexican Tomato Ban, and it included a profile of how these massive supply chain interruptions lead buyers to abandon well-vetted, quality suppliers and deal with source they are less secure about.

Now we hear from a jalapeno grower in Baja regarding how the FDA is repeating the same mistakes it made with Baja tomatoes:

My name is Doug Hermance, and I own a produce company, Pea King Produce, Inc., based out of Santa Maria, California.

I have a large chili pepper operation based out of Ensenada, Baja Mexico and have been reading all your articles related to the recent Salmonella outbreak and the possible implication of Jalapeno peppers as the source. I wish I could express in words the frustration and disgust I feel toward how the government agencies have conducted and reported their research without regard to those farmers whose livelihood depends upon these crops. I admire your work and respect your opinion, so I am contacting you in the hopes of at least having someone hear my story.

I currently have a Jalapeno & Serrano ranch located in Northern Baja Mexico, approximately 2 hours South of San Diego, CA, and we were harvesting nearly 10,000 40lb. cases per week, until July 21. I have always valued food safety and understand the importance of these programs to ensure the well being of the consumer. I have invested an immense amount of money and time to be proactive in the development and implementation of these programs.

My thinking was to be prepared for such an instance, thus separating my company and product from all those growers who do not have these programs in place. This would logically build the reputation of my company and eventually benefit all those who chose to do business directly with me.

I began the education process from the ground level, talking to the growers, field laborers, sorting crews; everyone involved in production; stressing the importance of being prepared for a crisis and having accountability for our product.

I contracted Primus Labs and conducted our audits, in which we scored very well; see links below. I then took the initiative to conduct periodic samples of our product to bolster consumer confidence and again, to be prepared if there was a security breach or contamination in our food supply chain. The FDA / CDC then issued a press release around July 2 citing Jalapeno as a possible source; and all future shipments would now be tested before allowing the product to go to market. We had approximately 10 samples tested by the government and we passed them all, we also continued to take our own samples and all have come back negative as well.

This was the EXACT instance I had been planning for. My company was prepared and I was proud to be able to show the records we had compiled before the possible link was established. Many of my competitors, including those in the United States, did NOT have their fields certified and did not have samples tested.

I was contacted by WGA, large produce companies and many growers, asking for my assistance in compiling information to present a valid argument to the government regarding the plausibility of a single Jalapeno as the magic link to the entire outbreak. The idea was to at least get clearance for growing areas and growers who had no possible link with the outbreak. I obliged and eagerly awaited the response, only to be appalled and dismayed at the most recent press release stating US Jalapeno were cleared but Mexico is now the likely source, and ALL Jalapeno from ALL parts of Mexico are now under intense investigation and should not be consumed.

The single Jalapeno was traced back to a ranch in Middle Mexico, and the actual scientific data and methods used in obtaining it are at the very least, questionable. My ranches are located 2 hours South of San Diego; so the comparison or blanket covering of an entire country is idiotic and simply not fair.

I am happy for the US growers, at least they will be able to resume harvesting, but accountability should be mandated for every grower in every region of production. What makes a ranch in Central California or Georgia any safer than my ranch in Northern Baja, especially when I can provide third-party documentation of clean and safe product during this entire process? The FDA / CDC has even supported my claim by testing my product as well; it is CLEAN & SAFE!

I now have to explain to my growers and the nearly 500 laborers that we cannot harvest the crops because the US Government has warned people about consuming Mexican grown Jalapeno and there is now no demand for our product. These people all have families and will now go through extreme hardships in their pursuit of finding another job, hopefully, before they go without food!

These people gave me their best effort to adhere to the food safety programs and did everything I asked of them. I am literally sick to my stomach as I think of the small children possibly going hungry and the lame excuse as to why their parents are not working.

I have demonstrated traceability and accountability of my work; is it within reason to ask the FDA / CDC do the same?

— Doug Hermance
Pea King Produce, Inc.
Santa Maria, CA

PS — The FDA / CDC are still saying don’t rule out tomatoes, are you serious?!

1. Corrective Actions Response

2. U.S. FDA — Notice of FDA Action 7/2/08

3. U.S. FDA — Notice of FDA Action 7/7/08

4. U.S. FDA — Notice of FDA Action 7/8/08

5. Mexican Lab Samples 7/14, 7/15, 7/18, 2008

6. Mexican Lab Samples #2 7/14, 7/15, 7/18, 2008

7. Primus Labs — Microbiological Results 7/15/08

Our heart goes out to Doug and to his workers. Just as we have always proclaimed, going back to the spinach crisis with pieces such as A Look At The Faces, that the victims of foodborne illness are real people and must never be forgotten, we think the victims of governmental action, such as the laborers on this farm, must also never be forgotten.

Yet our reasons for objecting to the continued restriction of Baja and many other parts of Mexico go beyond sadness at seeing innocent people and businesses crushed.

This sad treatment reaches to the essence of public health:

1. The politicization of public health.

Crucially, public confidence in the FDA depends on it being seen as even-handed and non-political. Every single thing it does must be seen as not influenced by politics but only driven by science and a concern for public health. Yet in this outbreak, this trust has been broken. The best explanation for why northern Florida tomatoes were exempted and Baja was not is simply that Florida has senators and congressmen and Baja does not.

The whole way the “not implicated” list was put together, where each political entity had to come and plead its case with the FDA, was inherently political and thus damaging to the FDA’s image. As Dr. Michael T. Osterholm pointed out in our interview with him, which you can read here, “… the formation of the FDA list is disingenuous. It was based on those that screamed the loudest, and from a public health standpoint, that’s not right.”

There is nothing in the science to implicate Baja any more than there is something in the science to implicate Georgia. The disparate treatment is a function of politics, not science and so is inherently damaging to the FDA and public health in general.

We need a strong and respected FDA, an FDA that consumers will listen to when it gives the all clear. But consumers are coming to see that this FDA is political and this politicization of the agency deprives the country of a valuable resource.

2. The inadvertent increase in risk by banning whole areas.

In banning whole geographic areas, the FDA focuses solely on the outbreak at hand. But this is inimical to the goal of enhancing public health. With Salmonella, for example, the CDC estimates that there are 1.4 million cases in the US each year and foodborne illness in total account for 76 million cases. So, when the FDA wants to consider a ban on a particular portion of the food supply, it is not enough to know if this action will reduce the likelihood of an individual falling victim to this particular outbreak.

Remember that 76 million foodborne illnesses a year translate into over 1.5 million per week! It is imperative to be certain that the action will not drive consumers to less safe product.

In dealing with produce, there is a significant reason to think that such broad bans do more harm than good — measured solely by the impact on public health. The high-volume chains that feed most Americans, companies such as McDonald’s and Costco, select suppliers carefully. They have much to lose from causing illness and so work diligently to vet the farms they work with and ensure they are utilizing the most advanced methods to enhance food safety.

When the FDA bans a whole geographic region, it compels these buyers to abandon their vetted farms and, instead, scramble to secure supplies from places they are unfamiliar with.

This means that the produce purchased is likely to be more risky, not less risky.

Clearly if FDA has information, it should share it but having done so there is simply no reason to usurp the judgment of McDonald’s, Costco and other buyers. If these buyers remain confident in their supply chain, the FDA has no reason to interfere.

Doug Hermance’s letter is poignant but at least he can write a letter. The consumer victims of FDA’s broad stroke actions are unheard from, but in forcing buyers to use unfamiliar sources, FDA has surely caused more foodborne illness than these broad bans prevent.




SPECIAL EDITION XII —
Salmonella Saintpaul Outbreak…
Let The Hearings Begin

Perishable Thoughts

As attention turns to Capitol Hill and these hearings while simultaneously, in this election season, we rely on our congressional representatives to solve the many problems illustrated in the Salmonella Saintpaul outbreak, we ought to remember some comic lines from Aristophanes:

If we withdraw the confidence we placed
In these our present statesmen, and transfer it
To those whom we mistrusted heretofore,
This seems I think our fairest chance for safety:
If with our present counselors we fail,
Then with their opposites we might succeed.

Aristophanes (446 –380 BC)
Frogs

Translated by John Hookman Frere (1769-1846)

At PMA’s town hall meeting on the Salmonella Saintpaul crisis, one would have to say that the tone of the questions indicates that much of the audience felt little had changed since the spinach crisis of 2006.

On the broad issue of CDC and FDA, there is broad consensus that they are not doing the job. The dispute is over why.

Many in the industry see incompetence and hostility to business — they want reform. Many in the food safety community see the CDC and FDA as having been starved of funds during the administration of President George W. Bush. They see the inept behavior of these agencies as a consequence of this funding shortage and a generalized hostility to regulation by President Bush. They look to an Obama administration as certain to fund the CDC and FDA robustly, assist the state health laboratories and, in general, support public health.

We wonder if they aren’t too optimistic, regardless of our next President’s predilections. Since World War II, the most salient fact about the Federal budget is that a larger and larger percentage of the budget has gone for various entitlement programs such as Social Security and Medicare. There are disputes about exactly how to calculate these things but, roughly speaking, entitlements overall have grown from a quarter of the federal budget during Eisenhower’s terms to about 65% today. Add in the military, interest on the national debt and other unavoidable or difficult-to-reduce expenditures and you see that any President and any political party is likely to be constrained by budgetary reality.

So it is that the population can find itself shifting its allegiance back and forth between parties, yet never having its will effectuated. Or maybe politics is wiser than that. Although at a time of outbreak it seems worthwhile to add resources to solve food safety problems, in the calm days of budget planning, it is recognized that so few get seriously injured from consuming fresh produce that budget allocations to deal with the “problem” are abandoned each time.

In the Gilbert and Sullivan Operetta, The Pirates of Penzance, which Joseph Papp revived in a production in which Linda Ronstadt, Rex Smith and Kevin Klein starred, a character sings a song explaining that he has all the qualities needed to be a Modern Major-General. Among the accomplishments that qualify him are that he “knows the croaking chorus from The Frogs of Aristophanes.”

Such useless knowledge — the chant repeats endlessly as follows: Brecece·cecs? cò·acs? cò·acs? (Hellènic: Βρεκεκεκέξ κοάξ κοάξ) — may be what we are in for on food safety, as everyone declares that not one illness is acceptable, but the great trends toward entitlement-spending leave the budget pretty much as is, under whatever administration we may have.

Perishable Thoughts is a new section of the Pundit. If you would like to share one of your favorite quotes with the industry please do so here.

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