Acheson - Ready to mandate traceability?

Go here for the testimony of David Acheson at the House agriculture appropriations subcommittee. His testimony has generated coverage from Reuters here, indicating that Rep. Rosa DeLauro was pressing Acheson on the issue of government mandated traceability. Here is what Acheson said in his testimony about traceability. From David Acheson's statement:


I would now like to describe some of our recent activities to improve product tracing of fresh produce. The ability to trace pathways of any food, including tomatoes and other fresh produce, through every point in the supply chain is crucial for limiting foodborne illness in an outbreak, for preventing future outbreaks, and for reducing the impact on the segments of the industry whose products were not associated with the illnesses. The pathways that fresh produce travels from field to consumer have become increasingly complex, with items sometimes changing hands many times in the supply chain.

FDA formed an internal multi-Center group to meet with external entities (such as industry, consumers, and Federal, State, local, and foreign governments) to better understand the universe of tracing systems that are currently in use or being developed. FDA has reached out to various organizations, including trade associations and consumer groups, to gain a better understanding of best industry practices for product tracing, including the use of electronic and other technologies that speed and enhance the tracing process and the use of systems that connect all the links in the produce supply chain. FDA is using this information to develop recommendations for the fresh produce industry to use to improve its internal tracing systems. We plan to hold two public meetings in the fall to further the exchange of information on available technology and best practices for enhanced product tracing.

We have been working extensively with States and the fresh produce industry to encourage incorporation of tracing procedures and technology. For example, FDA assisted the Florida Tomato Commission and the University of FloridaInstitute of Food and Agricultural Sciences in the development of Florida’s Tomato Best Practices Manual. This Manual incorporates Good Agricultural Practices, Good Handling Practices, and product tracing recommendations for industry. The Manual formed the basis of the State of Florida’s tomato safety rule.

Another recent example is the final guidance for fresh-cut produce, which FDA issued this year. The guidance includes a section on product tracing and a section on documentation and record keeping. FDA also provided industry its “Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations,” which is used by our investigators.

Last month, FDA issued a Request for Applications to provide funding to six States to establish Food Protection Rapid Response Teams to investigate multi-state outbreaks of foodborne illness. Enhancing the infrastructure of State food protection programs and strengthening joint Federal/State responsiveness at a local level are an important way to protect consumers by expediting product tracing investigations.

We also are planning to host a workshop at the University of Maryland during 2009 to review the status of a product tracing study on tomatoes and dairy that the European Union is currently conducting. This review will allow FDA to incorporate relevant findings from the EU study in our decision making. The EU began its four-year product tracing study in 2007 with the goal of ensuring total product tracing of food and feed along the whole chain from production to consumption. As part of this effort, the EU is developing, testing, and evaluating two full pilot product tracing systems, including one for the tomato food chain. We will continue to work with Federal, State, local and international food safety partners and with industry to conduct research, develop educational outreach materials, and initiate other commodity-, practice-, or region-specific programs to enhance the safety of fresh produce.

Q and A- Acheson on industry traceabiity

One reporter (I didn't catch the name) at today's briefing (Main message: the outbreak is over) asked a question about industry traceback and what is needed. Should there be better record keeping requirements and Good Manufacturing recommendations?

David Acheson of FDA responds:

"The traceback requirements are complex, as you point out, we are exploring various options. The agency is planning a public meeting in the fall - October or November time frame - to consult further with the stakeholders and those who are interested in this.

I want to emphasize that during the traceback ... it was a question of the agency was going to industry establishments and obtaining records. Rarely were those records not available. That was not the problem. It was that the records were frequently maintained as paper records and weren't electronic. Not that all the industry is like that. Certainly elements of the industry maintaining electronic records, but the vast majority of the establishments we went to in this investigation weren't. That's why things like interoperability, so that one part of the chain connects to the next, consistency of naming so that as, for example, tomatoes move through the system they don't change their name, which was something we had to deal with. Those are the types of things we are looking for, a multifaceted approach around traceback."

A Big Bowl of Wrong

As the salmonella saintpaul investigation dragged the tomato industry kicking & screaming into its third month, we entered the theatre of the bizarre in our nation's capital.

The Thursday hearings by the House Agriculture Committee were enlightening, poisoning, mis-informative & important all at the same time. Admittedly, it was insufferingly boring & pedantic at times, but there was no question we were viewing high drama when Rep. Bart Stupak (D-MI), tomato in hand, lasered in on Dr. David Acheson of the FDA with these words:

"Why can't you clear tomatoes at this time?"

A pregnant pause ensued, then Acheson went into his patented doublespeak, blaming the CDC, the methodology, the geographical logistics, everything except Greenwich Mean Time for not coming up with the jalapeno/serrano pepper connection sooner.

In fact, in the same way that the FDA's planet-aligning breaking news regarding the peppers had come mere hours before Acheson's testimony Wednesday, I was half-expecting a messenger on horseback to break through the doors of the Rayburn building with up-to-the-minute findings to bail out his tail again.

For awhile during Thursday's hearing, Acheson was under the gun to the extent that I almost started to feel sorry for him. Almost. His forehead was full of these horizontal lines, and he looked like he was in the throes of Excedrin headache #459. But my temporary insanity & sympathy ended once and for all when Acheson spoke to reporters after the hearings.

(From AOL News) "I don't think we can say that (tomatoes) were needlessly dumped," Acheson told reporters after the hearing. "The early part of the investigation clearly implicated tomatoes."

'Don't think that they were needlessly dumped'. Think about that one for a minute. That singular statement means that, according to this guy, there was a need to destroy millions of dollars of pristine merchandise just because some flawed statistical analysis by some bureaucrat thousands of miles away thought it the right thing to do, for 'the public good'.

See, that's their out, Acheson's FDA & the CDC & any other government agency lacking the moral DNA to ever admit a mistake. That's always their out, in the same way that Richard Nixon condoned the Watergate coverup under the guise of national security. Without even a scent of responsibility-taking, they threw the industry under the bus as naturally as they breathe.

What these hearings needed was a real live wire, someone not familiar with Robert's Rules of Order, a pure produce guy who went through these weeks of hell on earth, who didn't sleep at night wondering how all this got out of his control. You know, someone possessing the kind of rabid passion that comes from not knowing if he'll have a job when the sun rises the next morning.

Then maybe Dr. Acheson wouldn't have been able to skate so freely after the hearings as he did.

Later,

Jay

Breaking news

It was the kind of good timing that defies the odds. David Acheson of the FDA and Lonnie King of the CDC talk about a "smoling gun" in Mexico. Here is the link to the audio file where Acheson states, "Two hours ago.... CNN coverage below:

House hearing - The panelists

A long hort subcommittee hearing today chaired by Rep. Cardoza today, one in which the industry made a number of strong points. Still, Acheson may have trumped everything else that was said with news of the farm in Mexico where the salmonella Saintpaul pathogen was found. David Mitchell developing for The Packer....

First up - House Subcommittee on Horticulture

Here is the only Congressional hearing today. Rep. Rosa DeLauro's oversight hearing on the appropriations subcommittee - previously scheduled for today - has been postponed until after the August work period.


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. Brian Silberman, 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


TK: Here is the link to the witness list of tomorrow's hearing at the House Energy and Commerce Committee, oversignts and investigations subcommittee.

WG: Traceback is not the problem

Traceback is not the problem says this news release from Western Growers. This may be the critical debate in the upcoming Congressional hearings. If the industry can make a convincing case, lawmakers may give the industry more time to proceed with the industry's own traceability initiative. If not, expect mandates to be imposed sooner rather than later:


PRNewswire-USNewswire via COMTEX/ ----On June 7, the Food and Drug Administration (FDA) issued a consumer alert directing the nation to stop consuming certain types of tomatoes. To this date, the federal agency has not announced an end to the investigation or the source of the contamination. On June 27, the agency admitted that tomatoes may not have been responsible for the outbreak of Salmonella Saintpaul and said instead they "were keeping an open mind" about other commodities being responsible for the outbreak. Spokespersons for the FDA and Centers for Disease Control (CDC) have cited difficulty tracing product consumed by those who became ill back through the supply chain, and a number of consumer groups have used these statements to dust off their calls for the federal government to require an electronic traceback system.

Disputing these calls are the facts: Yesterday the Minnesota Star Tribune reported that the Minnesota Department of Health had traced the source of their outbreak in less than two weeks. According to the article, Minnesota health officials "were on the phone July 9 with their federal counterparts making it 'crystal clear' it was not tomatoes but jalapenos that were the likely source."

"Traceback is not the issue here," says Western Growers' President and CEO Tom Nassif. "The FDA and CDC initially claimed that tomatoes were the culprit. Now they are focusing on jalapenos. Were they looking in the wrong place? If so, no system of traceback, no matter how sophisticated would have made a difference in this two-month-long investigation." Corroborating this point, in an Associated Press article published today, Dr. David Acheson of the FDA was reported to dispute that an electronic records system would have helped investigators.

"Today there are good traceback laws in place that the produce industry supports and embraces," says Nassif. "Nevertheless, Western Growers supports a risk-based approach to mandatory traceback, designed in collaboration by industry and that meets the needs of regulators. To say that the less-than effective and slow pace of the federal government's investigation is because of traceback problems is way off the mark."

"There is no proof tomatoes were the culprit, but the entire industry is being made to pay the price for this early implication," says Nassif. "The FDA has a moral and legal responsibility to establish a threshold for announcing a commodity is unsafe and an obligation to work with industry to perfect its ability to trace products faster."

Western Growers is an agricultural trade association whose members from Arizona and California grow, pack and ship ninety percent of the fresh fruits, nuts and vegetables grown in California and seventy five percent of those commodities in Arizona. This totals about half of the nation's fresh produce.

SOURCE Western Growers Association

http://www.wga.com
 

Victim of their own success

Luis of the Fresh Produce Industry Discussion Group first linked to this AP story reads "Food industry bitten by its lobbying success"


One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it."
The industry pressured the Bush administration years ago to limit the paperwork companies would have to keep to help U.S. health investigators quickly trace produce that sickens consumers, according to interviews and government reports reviewed by The Associated Press.
The White House also killed a plan to require the industry to maintain electronic tracking records that could be reviewed easily during a crisis to search for an outbreak's source. Companies complained the proposals were too burdensome and costly, and warned they could disrupt the availability of consumers' favorite foods.
The apparent but unintended consequences of the lobbying success: a paper record-keeping system that has slowed investigators, with estimated business losses of $250 million. So far, nearly 1,300 people in 43 states, the District of Columbia and Canada have been sickened by salmonella since April.

Later....

The FDA official in charge of the current salmonella investigation, David Acheson, said the agency slowly is reviewing paper records to help trace tainted produce. But Acheson disputed arguments that an electronic records system would necessarily have helped investigators.

TK: One of the intriguing sidebars to the Congressional hearings upcoming will be the debate about traceability and what more needs to be done. Lawmakers will say the industry is "clamoring for regulation" but industry may not agree. Check this story for another report on traceability: "Tracing tomatoes from field to fork" From that AP story:

My impression is that before this tomato-pepper outbreak, the industry really didn't want traceback, because if they had a problem they didn't want it traced to a specific grower," said Michael Doyle, director of the Center for Food Safety at the University of Georgia. "Now, seeing that what can happen can shut down the whole industry, I would think it's to their advantage to enable traceback investigations to focus on the source."
Even if the government doesn't require tracing, some major retailers do.
"We like to get back to the dirt, or in the case of tomatoes, the hothouse," said Craig Wilson, assistant vice president for food safety and quality at Costco. Verifying the supply chain is a specification, just as freshness would be. Vendors are required to maintain records, which Costco audits at least annually.

Later in the story....

For Canadian cattle, FoodLogiQ's system works through a radio frequency ID tag put on every calf's ear at birth so its movements can be recorded. The system got its first emergency workout when mad cow disease was discovered in a Canadian cow in 2003, requiring traceback to the farm of origin before U.S. trade could resume, Kennedy said.
For produce, his company would assign an identifying tag to each case or pallet, rather than to an individual tomato or other item. It costs roughly 25 cents a tag, Kennedy said in a cell phone interview this week from a field belonging to Eastern Carolina Organics, a co-op implementing his system.
If the produce case is repacked into different boxes along the way to the grocery store or restaurant, the tag identifier would be added to the new container, much like drug companies today track their ingredients, Kennedy said.

FDA: Nationwide warning: Jalapenos

The jalapeno market is at serious risk today.

FDA's David Acheson announced a breakthrough in the case today. (Find link to audio of FDA teleconference here) A small distributor was identified in Texas (watch for David Mitchell's coverage on The Packer's news site for that name) from which a pepper was tested positive for Salmonella Saintpaul by an FDA lab. That has prompted the FDA to issue a nationwide warning for consumption of fresh jalapeno peppers. The pepper came from Mexico, FDA believes, but the warning is nationwide and includes jalapenos of all origins.

As far as where the trace-forward goes, the FDA is looking at distribution records, but said it won't release the names of retailers or foodservice distributors/operators who might have sold peppers from the distributor.

The FDA said all tomatoes are now safe to eat, but still won't exonerate tomatoes in the outbreak investigation as a possible cause earlier on.


Developing......

Headlines - Consumer confidence and traceability

Major league attention is being paid to the fresh produce industry these days. While the attention isn't always about the wholesome goodness or the unfailing attributes of fruits and vegetables, it is remarkable scrutiny nonetheless. Here are a couple of headlines from high profile writers that illustrate the point;

Tracking produce proves complex The Washington Post
From the story:

Investigators said the complexity of the produce distribution system has been their biggest impediment, and some produce industry leaders agree that tracing fruits and vegetables could be easier. Though the technology to do so already exists in the form of bar codes that appear on nearly everything we buy, it could take as long as five years before the entire food industry applies it to food safety.
Produce outbreaks are notoriously hard to trace. In at least half of all produce outbreaks, health officials have never determined what made people sick. The short shelf life of most fresh fruits and vegetables means it's less likely the items will still be in people's refrigerators when investigators come looking. Plus, there are many paths produce can take to reach consumers. In the salmonella probe, health officials said the practice of repacking made it harder to trace tomatoes to their source. Repacking involves sorting produce for size and color to meet a customer's specifications. Fresh tomatoes are often repacked, sometimes more than once. For investigators, the practice can open a multitude of new leads. Investigators trying to find the source of contaminated jalapeños have run into "the same spider web," said David Acheson, a top food safety official at the FDA.
For some produce industry leaders, references to spider webs sound like excuses for mistakes in judgment. "We are not dealing with failure of traceability. We are dealing with the fact that the trace-back did not support the single point of contamination hypothesis," said Tom Stenzel, president of United Fresh Produce Association. "We would submit that trace-back worked; we just weren't listening carefully enough to what it was telling us."

TK: The assertion by Stenzel and other industry leaders that "trace-back" worked will be closely scrutinized in upcoming hearings. Will this claim be supported by the officials at FDA or CDC? How does this position sync with the desire to get the industry moving on broader progress on traceability solutions for the supply chain? If trace-back worked, what's the rush on the part of industry players in moving forward with the traceability initiative? There is a delicate balance act going on between defending the industry, pointing out the errors of the FDA and preparing the industry for new demands and mandates.

Another headline: Food Safety Worries Change Buying Habits

TK: Jay Martini also linked to this AP story in another blog post. The upshot is that consumers "overwhelmingly support" setting up a trace-back system for produce, with four in five supporting "enforceable federal standards." As if on cue, the stars are aligning for Congressional action, it would seem.

United update: enjoy without regard to origin

From United Fresh, just sliding across the inbox;


Today, CDC and FDA officially announced that “consumers may enjoy all tomatoes that are available in the U.S. marketplace without regard for their origin.”
During a media briefing today about the ongoing Salmonella saintpaul outbreak, FDA Associate Commissioner for Foods David Acheson said that FDA was changing its advice because the farms identified thru the trace back investigations are no longer shipping tomatoes and because they did not find any evidence of contamination along the supply chains that were involved in the trace back investigations.
As evidence has mounted that tomatoes could not be contributing to this outbreak, United Fresh has urged FDA and CDC to change their earlier advisory, so we are pleased with today’s news. However, we continue to encourage CDC and FDA to now complete their investigation of Jalapeño and Serrano peppers quickly so that either the problem can be identified or, if not, these products can be cleared as well.
Both FDA and CDC will update their websites to reflect today’s announcement. CDC also indicated that it would include a graph of the outbreak illnesses on its website.
We will continue to keep you informed, but, as always, please contact us if you have questions. Amy Philpott, 202-303-3400 ext. 425 .

Big deal or no big deal

Is the salmonella outbreak, which has sickened over 1,000 - and made many tomato handlers substantially poorer - a big deal? Here is an interesting take passed on by Doug Powell of the Food Safety Network from NextGov on comments by David Acheson.

As of today, nearly 1,000 people have been sickened, one person has died, and at least $150 million has been lost by tomato growers and sellers (and probably more now that peppers, onions and cilantro are becoming suspects) because of a salmonella outbreak as of yet unknown origin.

Not to worry, though. It isn’t a big deal.

To quote Dr. David Acheson, food safety chief of the Food and Drug Administration, “We’re a nation of 300 million people who eat two-to-three times a day. To have 800 people sick is not that big of a deal.”

OK, Acheson has a point: 1,000 out of 304,554,835 (according to theUS Census population clock as of this post) is only 3.2834809534381550698415278811778e-6 percent, if my fingers hit the calculator correctly. [Which they didn't the first time - it should be .00003% - which a sharp reader caught - see comments below.]

But that perspective leads, of course, to the question of what does the FDA believe is a BIG DEAL?

Is it 3,000 people sick? 100,000? Even a million is only a statistical blip.

Or how about deaths? About 5,500 people die every day in the United States. One person dying from salmonella over a couple months is not a Big Deal either to the FDA, I gather from Acheson’s comments.

So, exactly what is the level necessary for the sick or dying to be considered a Big Deal?

Of course, not only do we need to know what a Big Deal is in relation to a single event, but also from a multiple event perspective.

Over the last decade, there have been 13 salmonella outbreaks from tomatoes alone. And this count doesn’t include other food-borne problems, like E. coli or Hepatitis A. (Remember spinach and green onions?)

Once we know what FDA's Big Deal risk threshold is (and what's the Agriculture Department's as well for meats and dairy products -- remember Taco Bell?), we can then start to figure out the true cost/benefit to putting in a food tracing system that Allan Holmeswrote about.

In fact, we may find that we don’t even need an FDA, as the late Nobel Prize winning economist Milton Friedman argued.

John Galt, Howard Beale & Me

In novelist/philosopher Ayn Rand’s 1957 magnum opus ‘Atlas Shrugged’, the theme of the epic describes a collapse of society from state intervention run amok. The story ends with the heroic character John Galt creating an alternative economic society out of the ashes, with reason & responsibility as cornerstones.

I was reminded of this great book when faced with the latest blurbs from the media outlets describing the cryptic quotes & faux-analysis from the FDA and, to a certain extent, the CDC.

It’s tomatoes…maybe. Or now it could be salsa, guacamole, cilantro or wash water. Here, or there. Or both places. Or neither. But tomatoes aren’t off the hook yet, according to David Acheson of the FDA. And, incredibly, he states that ”It would be irresponsible of us at this point to say where we are expanding the testing.”

Irresponsible?! For once, Acheson has made an accurate statement. That’s their expertise, you know---the FDA takes no responsibility for its actions, knowing full well that they can throw a morsel to the media blowhole, chiefly the broadcast media because nobody reads anymore, anyway. And the public takes the sanitized fodder on Good Morning America as gospel, steering clear of anything they seem to hear on TV that might make them sick. It’s the 1976 film ‘Network’ come to life.

‘It’s not our fault, we’re not to blame, we’re underfunded’, the FDA cries. Yet there were stories from last year of the FDA doling out more than $8 million in bonuses to workers so they won’t defect to pharmaceutical & other regulated industries. That’s bound to be under intense scrutiny now.

And Consumers Union isn’t helping the situation by saying “If FedEX can keep track of all its packages moving around the country, the produce industry should be able to do the same.” That’s a bad analogy at best, with a chaser of abject ignorance of the situation at hand.

It was Saturday night, June 7, when I received word that Subway was conducting an emergency meeting to pull tomatoes from their sandwiches. That’s when I knew the jig was up, and now it’s Day 25 of the tomato industry held hostage. This has completely crushed the South Carolina, Arkansas and California F.O.B. tomato markets to date, and has left really smart people in the tomato business at a loss for words. I didn’t think that was possible.

Later,

Jay

FDA: It would be irresponsible

The FDA's serpentine traceback investigation - and the industry's reaction to it - continues to be the top story in the fresh produce industry. The article below was linked by Doug Powell and the International Food Safety Network, from Health Day News:

With the number of people sickened in the nationwide salmonella outbreak now standing at 869, with 107 hospitalizations, U.S. officials acknowledged Tuesday that they were no closer to identifying the source of the contaminant.
The U.S. Food and Drug Administration also announced it was expanding its investigation to include food items normally served with tomatoes. While tomatoes are still the leading suspected source of the bacterial infections in the two-month-old outbreak, officials said they can't rule out other food items associated with tomatoes. But, they declined to say what those other foods might be.
"It would be irresponsible of us at this point to say where we are expanding the testing," said Dr. David Acheson, the FDA's associate commissioner for food protection. "I'm not prepared to discuss what those items might be."
"The tomato trail is not getting cold, rather other items are getting hotter," he added.
Acheson said the FDA has also activated the Food Emergency Response Network, which could bring to 100 the number of laboratories across the country working to identify the source of the outbreak. The network has been activated before, specifically during the spinach outbreak and the contaminated pet food outbreak in 2007.
Dr. Robert Tauxe, deputy director of foodborne, bacterial and mycotic diseases division at the U.S. Centers for Disease Control and Prevention, also said at the teleconference that his agency was conducting a multi-state investigation focusing on the 179 people who have fallen ill since June 1. He did not explain why the CDC was zeroing in on that group of people.
Meanwhile, the advice to consumers remains the same, Acheson said. Avoid raw red plum, red Roma, round red tomatoes, and products containing these raw tomatoes.
To date, infections have been reported in 36 states and the District of Columbia, making it the largest produce-linked salmonella outbreak in U.S. history. There have been no deaths, officials said.
Also Tuesday, the Bush administration's top health official expressed frustration that the salmonella outbreak hasn't been solved yet. Health and Human Services Secretary Michael Leavitt asked Congress for more money and stronger legal powers for food import safety agencies, the Associated Press reported.
CDC officials first acknowledged on Friday that they were no longer sure that the Salmonella Saintpaul outbreak was due to tomatoes alone, or some other food source.
"Whatever this produce item is that's causing illness is probably still out there making people sick," Dr. Patricia Griffin, chief of the Enteric Diseases Epidemiology Branch at the CDC, told reporters late Friday at a special press teleconference.
Health officials have said all along that the bulk of the tomatoes available at the start of the outbreak in mid-April had come from Mexico and parts of Florida. The FDA had sent teams of investigators to Florida and Mexico last month to inspect farms, packing houses and distribution centers.
One factor complicating the search for the cause of the outbreak is a common food industry practice called "repacking."
"Repacking is a situation in which a supplier or a distributor will repack tomatoes to meet a specific customers' requests," Acheson explained. "So, if a customer is wanting small, ripe tomatoes and the supplier does not have a box of small ripe tomatoes, then they will typically go through multiple boxes and pull out ones that meet customers' specifications and repack them. It's a very, very common practice. We've seen reports that it may be as common as 90 percent of tomatoes get repacked, but we don't have confirmation that the number is that high. Obviously this complicates the trace-back," Acheson said Friday.
He also said that it was possible that tomatoes were contaminated at a packing and distribution center, not a particular farm. That means that produce from states that have been cleared may have gone through packing or distribution houses elsewhere, and become contaminated there.
The food poisoning scare ranks as the largest on record in terms of illnesses linked to tainted produce, the CDC said. "This is so far the biggest outbreak with this number of illnesses confirmed by culture," Griffin noted.
More than 300 of the total cases from the current outbreak have come from Texas. Patient ages range from under 1 year old to 99 years old. Half the victims are women.
Salmonella is a bacteria that can cause bloody diarrhea in humans. Some 40,000 cases of salmonellosis are reported in the United States each year, although the CDC estimates that because milder cases are not diagnosed or reported, the actual number of infections may be 30 or more times greater. Approximately 600 people die each year after being infected.
However, the strain of Salmonella Saintpaul had been previously considered rare. In 2007, according to the CDC, there were only three people infected in the country during April through June.

Another FDA briefing

I'll call in to report any developments, but it doesn't appear to be a breakthrough news event this afternoon....

WHAT:
A media availability with experts from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention to answer questions about the ongoing investigation of the salmonella outbreak among certain types of tomatoes.

WHO:
--David Acheson, M.D., associate commissioner for foods, FDA
--Melinda Plaisier, associate commissioner, Office of International Programs, FDA
--Faye Feldstein, acting director, Office of Food Defense, Communication and
Emergency Response, Center for Food Safety and Applied Nutrition, FDA
--Steve Solomon, deputy director, Office of Regional Operations, FDA
--Patricia Griffin, M.D., chief, Enteric Diseases Epidemiology Branch, CDC


WHEN:
Friday, June 27, 2008, 3 p.m. EDT

Tomatoes and salmonella: avoiding ambiguity

I talked to a distributor of Mexican tomatoes in Nogales today who said they were now selling about 60% of their production from Sonora at depressed prices, leaving 40% behind in Mexico.

No word yet about the FDA investigative team in Mexican, other than the fact they are apparently traveling with their Mexican counterparts and super secretive about where they are going and what they are looking for.

The distributor's biggest concern is that the FDA will come up with an ambiguous result, with no certainty of where the contamination occurred and what caused it. He also chafed at the idea that the FDA's David Acheson is using the occasion to ask for more authority for the agency. "We have all been 100% cooperative."

Meanwhile, the FDA said they may have another conference call this afternoon. A little illumination, gentlemen?

At this point, can we call the FDA's management of the salmonella investigation incompetent, as some have said? Certainly, the FDA's advice to consumers has been confusing. Many loads of good tomatoes have been thrown away. Yet the contention by some critics that the outbreak is over doesn't seem to be supported by facts. The CDC today pushed the number of victims of salmonella saintpaul higher again, to 707.

I think the industry should tread lightly in respect to damning the agency's efforts. I don't think you will hear PMA or United describing the FDA investigation with the term "incompetence."
Frankly, I would be shocked if they ever did. Until I hear United's David Gombas and PMA's Bob Whitaker call the FDA incompetent, I tend to discount any such talk by anyone else.

Don't forget that one of the big hurdles the agency faced in their traceback investigation was the apparent absence of an effective industry traceability/record keeping system for fresh tomatoes.

The most unsatisfying result for the FDA's traceback investigation would be ambiguity. If that is the result of these weeks of travail, perhaps "incompetence" may not be too strong a characterization.

United update

Industry members will be glad they have their national associations to help deal with the tomato/salmonella issue, though it may hard to appreciate that fact in the midst of the outbreak. Reflecting both the urgency of outreach by the association and the unchecked exasperation in the tomato industry that has hounded this outbreak, here is an update from United that reviews the basics of the FDA press conference. (edited to remove some personal details of cell phones)

June 20, 2008
Dear Produce Industry Members,
Below is an update on the Salmonella saintpaul outbreak associated with Roma (plum) and red round tomatoes not still on the vine. I will be available over the weekend on my cell phone if you have any questions. Regards - Amy Philpott, United Fresh
FDA Traceback Investigation Update:
While FDA has not identified the source of contamination, the agency announced today during a media briefing that it has completed the traceback for some of the tomatoes from the point of consumption back to farms in both Florida and Mexico. FDA is working to narrow the investigation and identify the contamination point by conducting joint investigations with authorities in Florida and Mexico, sampling both domestic and imported product, and continuing to pursue new traceback investigations.
This weekend, FDA inspectors will look at points all along the traceback supply chain to further narrow the scope of the investigation. According to Dr. David Acheson, associate commissioner, FDA, “Now that FDA has identified the paths that those tomatoes have travelled between the farms to consumers, FDA will be looking all along those pathways to see where the contamination occurred.” Acheson emphasized that FDA will be looking at all points along the traceback supply chain, not just farms.
FDA’s advice to consumers, retailers, restaurateurs and food service operators has not changed and a list of tomato production areas NOT ASSOCIATED with the outbreak can be found on FDA’s website.
CDC also updated its website today, reporting that 552 persons infected with Salmonella saintpaul with the same genetic fingerprint have been identified in 32 states and the District of Columbia. The onset of illness dates range from since April 10 to June 10. CDC considers this an ongoing outbreak.
Click here to read a transcript of FDA's media briefings

As always, we will keep you updated as new information becomes available.

As a side note, we have heard from many of you this week regarding our joint industry letter to federal health officials; thank you for your input and support. Thank you also for your comments regarding Wednesday's Inside United Fresh story, "When Doing Our Best Isn't Good Enough." We look forward to working, on behalf of the industry, with government officials to improve outbreak management.

United Fresh Produce Association
1901 Pennsylvania Avenue NW,
Ste 1100
Washington, DC 20006

FDA - Teams being sent to Mexico, Florida

The FDA announced today that traceback investigations lead back to tomatoes from farms in both Florida and Mexico. A caveat is that the FDA doesn't think salmonella saintpaul - a relatively rare strain - could have come from both regions concurrently. The FDA said there is not a preponderance of evidence to implicate one region over the other at this point.

Teams are being sent out to farms in both regions and "pathways" to point of purchase or consumption (repackers, distribution centers) this weekend, but the FDA made it clear that the agency was not assuming the contamination occurred on the farms. David Acheson said it is possible the contamination could have occurred later in the supply chain. Basic consumer advice will remain the same. Now sickened by salmonella saintpaul are well over 500 people in 32 states, thought to be the biggest salmonella outbreak related to tomatoes ever.

Teleconference - More victims, no "answer"

The FDA/CDC reported today in the press teleconference that the number of victims associated with the salmonella outbreak is now 383 in 30 states and the District of Columbia. The most recent onset date of illness from salmonella saintpaul is June 5.

"We don't believe the outbreak is over." one CDC official said.

Nothing new on the investigative front; FDA officials continue to talk to health officials in Florida and Mexico,

"We're going flat out," said David Acheson of the FDA. Optimistic but realistic - the agency is beginning to reduce expectations investigators will find the farm or packing shed associated with the outbreak.

When a reporter asked him about whether the agency wants mandatory preventive controls for tomatoes Acheson said the FDA is waiting for legislative authority to do just that.

Traceability: A lost industry initiative?

Has the salmonella outbreak linked to tomatoes torpedoed hopes of an industry-led solution to traceability? I don't know the political dynamics of produce safety legislation on Capitol Hill, but I perceive the reality of a government imposed solution is closer than ever after the turmoil associated with the salmonella outbreak.

Take, for example, the House Energy and Commerce Oversight Investigation subcommittee hearing today. A couple of themes were country of origin labeling and traceability. Importantly, committee vice chair Rep. Diana DeGette, D-Colo., engaged FDA food safety official David Acheson repeatedly on the traceability issue. The net of the exchanges was that Acheson agreed that the salmonella outbreak has moved traceability to the front burner at the agency.

That gives me the sense that FDA might not be averse to a legislative, mandated solution.

DeGette, for her part has been getting press for her legislative push for traceability. The Denver Post writes about DeGette:

(DeGette) said that what is needed is a tracing system that would allow federal inspectors to almost instantly find where food produce was contaminated. She has proposed such a tracing system in her bill H.R. 3485, the TRACE ACT.

On its editorial page today, The Washington Post backed passage of DeGette's bill.

The Washington Post editorial said that nestled within the Food Safety Act of 2007, under consideration in the House, is DeGette's provision that would give the Agriculture Department and the FDA power to issue a mandatory recall of contaminated food.

"This is more than reasonable," said The Post editorial, "since the federal government can and did recall lead-tainted toys imported from China last year. Besides, the hammer of potential government action would be a powerful incentive for growers and packers to conform to safety standards."

Packer coverage from May 12 about the traceability steering committee:

David Gombas, senior vice president of food safety and technology for Washington, D.C.-based United Fresh, said the steering committee of the traceability initiative met Jan. 9, Feb. 22 and April 11 and is scheduled to meet again June 12. The initiative is sponsored by the Newark, Del.-based Produce Marketing Association, the Canadian Produce Marketing Association and United Fresh. Forty-one companies are participating, with nine foodservice operators/distributors, 13 retailers and 19 grower-shippers.

Gombas said the January meeting brought is consensus on four key points:

* the GS1 standard is to be used achieve whole chain traceability;

* a timeline is needed achieve whole chain traceability;

* a public declaration is needed by each company; and

* start at the case level, with strong provision to move to item level.

Gombas said the June 12 meeting will establish timelines for each milestone on the path of supply chain traceability. In comments after the session, Proctor said the steering committee might set a timetable for implementation in a range from 18 months to five years.

TK: I don't know if the steering committee's work was postponed by the salmonella outbreak, but the urgency for industry led action on traceability has never been greater. Without an ambitious timeline for industry adoption of "whole chain traceability," the government will mandate a solution. Whether that solution will make sense for the industry will be secondary to the urge by Congress to act. In fact, the events of the past month or so may have made the work of the steering committee only a footnote in what will be a government imposed solution.