Lost opportunity?

I was talking with David Plunkett, a lobbyist for the Center for Science in the Public Interest, earlier today about his perceptions of the produce industry position on traceability. (Find his powerpoint presentation here to the Oct. 16 FDA traceability meeting)

While commending the industry's recent push toward a more efficient traceability system, he said the industry was "feeling the pain" from the ineffectiveness of the 2002 bioterrorism law. Rather than have a efficient traceability system in place as a result of the 2002 law, he said what emerged from the regulatory process to implement that law was a weakened "one step up and one step back" approach. Likewise, instead of the entire industry of sharing the costs of an efficient traceability system starting in 2003, the costs and penalties for an ineffective system have shifted to subsets of the produce industry - namely leafy greens and tomatoes. He pointed to the July 31 testimony of William Hubbard (Coalition for a Stronger FDA) before the House Energy and Commerce, Oversight and Investigations subcommittee. From Hubbard's testimony on July 31:


As you know, after the September 11 attacks seven years ago, Congress was concerned that the food supply could be vulnerable to terrorism, and enacted the Bioterrorism Act of 2002 (formally titled the Public Health Security and Bioterrorism Preparedness and Response Act). One provision of that statute required food firms to establish and maintain records detailing the movement of food through the supply chain, with the intention of giving FDA the ability to rapidly trace sources of contamination; and thereby blunt the potentially devastating effects of intentionally contaminated food.
Unfortunately, the transition from what was believed needed right after 9/11 to what they agency actually got months later when it promulgated its regulations on recordkeeping is
a virtual case study in how to weaken a regulation to the point of being indistinguishable from the original intent. Indeed, if we were to consider the tomato/pepper salmonella search as a test of the recordkeeping rule, I think it’s fair to conclude that the grade would be a fairly clear “F.” Let me explain, and in so doing describe why the old axiom of not wanting to watch laws or sausages being made can also apply to implementing regulations.
Below is a brief “side-by-side” analysis of some of the key weak points introduced into the original legislation and regulation as it was being reviewed and considered by Administration reviewers:


What FDA wanted/needed Final Rule Provisions
Records by all sources/recipients Farms and restaurants excluded
Foreign firms as well as U.S. Foreign firms dropped
Complete record of a food’s movements Only “one forward, one back”
Lot numbers for each shipment Denied
Electronic records (for speed) Denied
Records access within 4 hours Extended to 24 hours
Consistent record format Denied
Authority to verify keeping of records Denied
Authority to enforce requirement Only (mostly enforceable) “prohibited act”


In sum, the theory after 9/11 was that the agency needed rapid access to complete and useable records of a food’s origins and movements, to deter and react to a terrorist attack.
What it ended up with was a requirement for partial records, made available in no particular hurry, from some people but not others, without a requirement that a given shipment be well identified, and in a format that could (and does) include the back of a plain brown paper bag. Further, the word quickly went out among the industry that FDA could only check on a firm’s adherence to the recordkeeping requirement if a food connected to the firm was the subject of a serious (“Class I”) recall and that the firm was unlikely to be punished if it ignored the recordkeeping requirement entirely.
One reason that the recordkeeping requirements were so watered down was the fear that they would be too costly for the food industry, with some estimates that the rules could cost processors $140 million per year. But, of course, the produce industry lost that much in the 2006 E Coli outbreak and is on track for similar losses in the ongoing Salmonella Saintpaul investigation. While our reluctance to impose regulatory costs is understandable, it may also be contributing to an ineffective regulatory structure and, in turn, the destruction of industries that rely on regulators to make rapid and accurate decisions about public health threats.


TK: Fast forward to next year; given the version of events prevented above - and the timeworn but true "you are only as strong as your weakest link" adage - it makes sense for the industry to agree to a deadline for mandatory supply chain implementation of the Produce Traceability Initiative.

Center for Science in the Public Interest presentation - FDA public meeting on traceability Oct. 16

What's old is new again

The FDA's notice about its intent to update 10-year old Good Agricultural Practices is found here. There is a lot to cover in that document so I may take it by sections. Meanwhile, let's reflect on what Packer legend Larry Waterfield wrote in the paper 11 years ago when the first round of GAPs was being readied. Deja vu all over again...





From November 1997.....

Ideas cover broad range FDA proposals could lead to more control over produce industry.
By Larry Waterfield
Washington, D.C., Editor
ARLINGTON, Va. -- The federal government's forthcoming voluntary guidelines for the produce industry will touch every aspect from the field to the receiver and could mean more stringent controls on imported produce and even so-called ``traceback'' mechanisms.
The aim of federal agencies, led by the Food & Drug Administration, is to have draft proposals ready by Dec. 1, with proposed guidelines prepared by late January and final guidelines in place by June.
FDA officials plan to put guidelines in place in 1998 for high-risk fruits and vegetables, which have yet to be named.
At a meeting Nov. 17, which involved federal agencies, a government panel on microbes in food and produce industry representatives, the agency officials pointed out that the guidelines, which are being referred to as ``the Guide,'' will be voluntary. But several industry officials said receivers and retailers are likely to latch onto the guidelines and require suppliers to follow the government guidance.
The next move in the process will be a series of seven public meetings across the country to get input from the produce industry. One meeting will deal with international produce safety issues. Those meetings begin Dec. 1 in Grand Rapids, Mich.
Those attending the Nov. 17 meeting got a preview of what may be in the proposed guidelines. They will deal with water quality, irrigation water, the use of manure in production, field sanitation, packinghouse sanitation, storage, cooling, refrigeration, handling, bins and packaging, packing lines, worker sanitation and transportation. The guidelines will be in the form of Good Agricultural Practices and Good Manufacturing Practices, referred to as ``GAPs and GMPs.''
The agencies are considering calling for anyone who handles produce from the field through the distribution system to wear disposable gloves. Guidelines may call on producers to make special efforts to divert deer and other wildlife from fields and orchards.
Companies may be asked to implement personal hygiene training programs for workers at all levels.
Methods to trace produce back to its source are likely to be a part of the guidelines as a way to limit any outbreaks of foodborne illnesses.
``These proposals represent our current thinking,'' said Thomas Gardine, director of the FDA's division of imports and a key official implementing the President's Produce Safety Initiative.
At the industry-government meeting the scope of the initiative began to emerge. Several Cabinet departments, 12 federal agencies and thousands of inspectors and government workers will be involved at the federal and state levels. The USDA will involve about 6,000 of its Extension Service personnel, plus researchers. A representative of the National Association of State Departments of Agriculture said the states have several thousand employees who are ready to take part.
On imported produce, officials are calling for more border surveillance and screening. The bill, the Safety of Imported Food Act of 1997, gives the FDA the authority to make sure foreign food safety systems match those in the United States, and it gives the agency power to block imports if inspectors are denied access to foreign facilities.
``There is no evidence that imported fruits and vegetables are more likely to be contaminated than domestic produce,'' said Lee Frankel, president of the Fresh Produce Association of the Americas, Nogales, Ariz., which represents importers of Mexican produce.
He warned that U.S. safety inititatives must treat imported produce fairly and equally and that the rules or guidelines must be in accord with international trade agreements under the World Trade Organization and must not interfere with U.S. trade obligations.
He cautioned officials not to make ``prejudicial statements'' that imply that foreign produce is not safe to eat when traveling in those countries and that indicate the imports may not be safe.
He said ``these officials show lack of knowledge and understanding of the farming, harvesting, packing and shipping processes.''
He said he is concerned that the ``guidance'' will focus on imports and will allow U.S. inspectors to block imports but will not treat U.S. produce the same under ``voluntary'' guidelines.
He urged the officials to hold a fact-finding meeting in Mexico or on the border and to come to Mexico to see practices.
Stacey Zawel, director of science and regulatory affairs at the United Fresh Fruit and Vegetable Association, Alexandria, Va., urged the government to recognize that produce is unlike other food industries and is made up of many diverse industries.
She pointed out that there are many gaps in the knowledge about microbial contamination of produce. She said the Industrywide Guidance, developed by 20 produce groups, focuses on the most critical microbial issues.
``A failure to bring focus to the microbiological food safety issues will squander scarce resources and dilute the effectiveness of our efforts,'' she said.
Fred Shank, director of the FDA's Center for Food Safety and Applied Nutrition, said there are funds available under the President's Initiative to carry out research into microbial contamination of produce.
Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, which she said represents more than a million U.S. and Canadian consumers, called for mandatory HACCP rules for the produce industry.
``CSPI urges the Clinton administration to mandate HACCP systems for the produce industry rather than guidelines,'' she said. ``Guidelines will not address the problems of the domestic industry, and they will be unenforceable internationally.''
She said the goal must be to ``identify and eliminate the sources of contamination for fruits and vegetables.''

Why not? Display health inspection scores

In a world where consumers expect more information rather than less and disclosure rather than concealment, the Center for Science in the Public Interest makes a compelling argument for public disclosure of health inspection reports at restaurants. From the CSPI Web site and a release dated Aug. 7:

WASHINGTON—In Atlanta, chicken salad stored at a balmy 50 degrees. Inadequate hand washing in Boston. Mouse droppings in a Minneapolis ice machine. A live roach scampers across a Pittsburgh cutting board. These are some of the gory details uncovered in an analysis by the Center for Science in the Public Interest of 539 restaurant inspection reports from 20 cities. Two-thirds of restaurants had these and other high-risk food safety violations.
Today CSPI, the nonprofit nutrition and food-safety watchdog group, is calling on state and local governments to require restaurants to display food safety letter grades in their front windows. Letter grades have been used in Los Angeles county restaurants for the past 10 years, and that popular measure is credited with reducing the number of hospitalizations due to foodborne illness. Las Vegas and St. Louis have adopted similar measures recently.
Over 40 percent of the outbreaks of foodborne illness were linked to restaurant foods, while only 22 percent were linked to food prepared in private homes, according to CSPI’s Outbreak Alert! database. CSPI’s new review of restaurant inspection reports—which typically covered 6- or 12-month periods—found that 26 percent of restaurants surveyed had contaminated food contact surfaces; 22 percent had improper food holding temperatures, and 16 percent had inadequate hand-washing by employees. Thirteen percent of restaurants had rodent or insect activity documented in their inspection reports.
"A letter grade in the window has proven to be one of the most powerful incentives for restaurants to perform well on inspections," said CSPI staff attorney Sarah A. Klein. "Who wants to eat at a 'C' restaurant if a restaurant next door gets an 'A'? Unfortunately, in many of the cities we looked at, not only are there are no letter grades, but the actual inspection reports are nearly impossible for citizens to obtain or understand."
In Pittsburgh and Washington, DC, restaurant inspection reports are only made available when consumers lodge written requests under those jurisdictions' Freedom of Information Acts. In some cases, CSPI researchers had to make several requests, by mail and telephone, and wait six months to receive the requested reports. In Atlanta and San Francisco, restaurateurs are at least required to keep the most recent inspection report on hand and show it to anyone who asks. Boston, Chicago, Denver, and Philadelphia are beginning to post inspection reports or scores online, but few consumers dig down into their city or county health department’s web site before going out for a sandwich.

"The results of our grading system in Los Angeles have been very positive, with improved restaurant sanitary practices, reduced rates of severe food-borne illness, and high consumer confidence in this key public health regulatory system," said Dr. Jonathan Fielding, director of public health for Los Angeles County. "We appreciate the work of CSPI to encourage greater adoption of this important food safety improvement that can benefit everybody who eats out."
Besides recommending that cities and states adopt the posting of inspection grades, CSPI says the Food and Drug Administration should revise its model food code to include easy-to-understand inspection forms and grading cards. State and local governments use the model food code as the basis for their restaurant inspection practices.

TK: One could argue that posting a negative health inspection score on the door of a restaurant is a kiss of death the already fragile industry could do without. Yet, that same knife hanging over the head of operators could be a powerful incentive to perform well in food handling and preparation. And if consumer health is a top priority for the foodservice industry, there is no credible reason why the public should be denied access to the results of inspection reports.

Unsolved mystery- salmonella investigation

After a week on the move in Honduras, I have not kept up with the ebb and flow of the salmonella investigation. As I read the news accounts in the consumer press this morning, I see it is mainly the ebb and waning of the investigation once thought to have secured a "smoking gun." From the Web...

Food safety laws under scrutiny from The Miami Herald:

This summer's salmonella outbreak could go down as the national food supply's biggest unsolved mystery.
Instead of a smoking gun, the only clue is a single tainted jalapeño pepper with the rare strain of Salmonella Saintpaul found at a Texas produce distribution center.
The difficulty in finding answers to one of the nation's most complicated and longest-running food-borne-illness cases has turned a spotlight on the beleaguered Food and Drug Administration, as well as the system for protecting the U.S. food supply.
Tomatoes, the original suspect, have been released from questioning but not exonerated. Now federal inspectors have fingered jalapeño peppers from Mexico as a potential source of contamination. But the trail is getting cold, and it's getting hard to find enough evidence to isolate the source of an outbreak that has sickened 1,294 people since April.
Critics say it's evidence of a system that is broken and desperately in need of an overhaul.
''The bottom line is this is not working,'' said Carl Nielsen, a 28-year veteran of the FDA and former director of import inspections. ``There have to be radical changes.''


Honduran melon farm caught in the middle Also from The Miami Herald:

It took a single news release to undo what it had taken the Molina family 30 years to accomplish. In March, the Food and Drug Administration sent out a global news alert saying it suspected that a salmonella outbreak in the western United States was linked to cantaloupes grown on the Molinas' farm in Honduras.
Overnight, the farm lost most of its business as the United States closed its borders to its melons. Then the family began to field calls from jittery distributors as far away as England and the Netherlands.T
Four months later, the FDA has yet to prove that the salmonella strain originated at the Molinas' 7,400-acre farm, Agropecuaria Montelibano.
The family's company, Grupo Agrolibano, claims that it has tested more than 600 cantaloupes in collaboration with distributors in Europe and the Americas and that all tests came back negative.
It has been trying to convince the FDA that Montelibano was not the source of the outbreak. Yet the import alert, which bars shipments of the Honduran melons from entering the United States, remains.


TK: One melon exporters I visited with in Honduras (not the Molina operation) believes that the issue become too politicized in Honduras, to the detriment of resolving the issue. More on that later.

The Herald also publishes a infographic from the Center for Science in the Public Interest about foodborne illness outbreaks. From that chart:


Each year, food-borne illnesses cause an estimated 5,000 deaths and 76 million illnesses in the United States. Between 1990 and 2005, the Center for Science in the Public Interest identified 5,316 outbreaks. Food categories most commonly linked to the outbreaks were:
Seafood: 1,053 outbreaks involving 10,415 individual cases
Produce: 713 outbreaks involving 34,049 cases
Poultry: 580 outbreaks involving 17,661 cases
Beef: 506 outbreaks involving 13,873 cases
Eggs: 352 outbreaks involving 11,224 cases
Source: CSPI


TK: Here is some more coverage on the issue from The Houston Chronicle:

Nations differ on tests for peppers From the Chronicle's Seam Mattson:

HIDALGO, MEXICO — The lab results on Sergio Maltos' desk show that investigators from Mexico and the United States came to drastically different conclusions about the cause of the salmonella outbreak that sickened more than 1,300 Americans this summer.
Investigators from both nations visited the farm in question, about 200 miles south of Laredo in Tamaulipas state, in July to test nearly identical materials.
The Food and Drug Administration found irrigation water and a serrano pepper that tested positive for the salmonella Saintpaul strain. Maltos, a top official at the Nuevo León state laboratory that processed Mexico's samples, had two positive tests as well — one from animal excrement and one from mud near an irrigation ditch.
The water and peppers Mexico tested, however, were clean, he said.
How the FDA and its Mexican counterparts managed to reach such different conclusions in a binational health scare that has cost farmers millions of dollars is a mystery neither government seems in a hurry to clear up.



Later......

Mexico, which repeatedly denied having the salmonella Saintpaul serotype in the country even before testing was complete, said Acheson's statement broke an agreement that the two nations were to release findings simultaneously.
Last week, Mexico had not finished the tests required to determine whether its positive salmonella tests matched the strain responsible for the outbreak, Maltos said.
As Mexican farmers fulminated over the second FDA warning in a year to hurt their bottom line, Mexican federal health officials and the FDA declined to explain their conflicting findings.



TK: Whatever the facts of the case may be, consumer confidence in the safety of Mexican produce has taken a major hit, though perhaps not the damage the FDA has inflicted on itself by its ultimately unresolved investigation.

Here is a piece from The Des Moines Register about the likelihood of increased regulation next year.

Unsafe food leads to calls for increased FDA authority more authority From the story by Philip Brasher:

Little is likely to get done this year - it's too close to the election - but a food agency overhaul is likely to be high on the congressional agenda next year. The food industry, which once resisted increased regulation, has been hammered with one costly outbreak after another. The latest, involving a strain of salmonella bacteria, devastated the U.S. tomato industry before it was linked instead to Mexican-grown jalapeno peppers.The agency itself is asking for more authority.
"You will see the food industry being supportive of government action," said Bryan Silbermann, president of the Produce Marketing Association. "We've seen what's happened over the last eight years of government inaction."


Later.....

It's not clear how much Congress is likely to do to change the way outbreaks are investigated. That job is divided among federal agencies as well as state and local authorities with varying levels of funding and expertise.Durbin isn't ready to talk about something as sweeping as unifying the food-safety system. That would mean merging various committee chairmen who now share jurisdiction over the food agency, Agriculture Department and other agencies that oversee food. Better to start with bolstering the food agency, he said.
"We have to allow this agency to mature into an effective 21st-century agency to protect families," he said.


TK: Just how produce safety regulations will be enacted to provide the appropriate risk-based and commodity specific approach is one question I have. Congress may legislate with a blunt instrument and leave it to the industry and the FDA to sort it out. This process will take years, I fear...

CSPI: Stronger bioterrorism regs would have helped

Although it may seem fresh produce growers and marketers have plenty of room to express their grievances with the FDA, others will have a different perspective. Where the industry sees too much power in the hands of the FDA to ruin the industry, others want to give the FDA more power. Clearly, "traceability" debate is where the industry faces the biggest risk of new mandatory controls.

July 21 statement of CSPI Food Safety Director Caroline Smith DeWaal

More than 1,200 Americans have gotten sick and two people have died after eating produce contaminated with Salmonella Saintpaul. With an investigation spanning many weeks, food safety regulators have had a challenging time trying to track suspected tomatoes and peppers up or down the supply chain, hampered by paper records and repacking practices that effectively hide the identity of produce in the distribution chain.

Today FDA announced an important breakthrough in the case: A Jalapeno pepper from a Mexican farm -- repacked at a Texas distribution facility -- has been found with the identical strain fingerprint of Salmonella as the human victims.

Though we still do not know where or how the contamination occurred, what we do know is traceability tools that Congress adopted in the 2002 Bioterrorism Act were significantly watered down by the Bush Administration. In fact, in 2003, food industry lobbyists had special behind-closed-doors access when the Bush Administration was vetting new anti-bioterrorism regulations aimed at protecting the food supply from intentional contamination. Provisions stripped from the regulations, like requirements for distributors to record lot or code numbers, and requirements for record availability in 4 to 8 hours, might have been helpful nailing down this Salmonella outbreak much earlier.

At the time, the industry complained that strong provisions were overly burdensome, and the Administration watered down the regulations in response. Those complaints must seem quaint compared to the hundreds of millions of dollars this one outbreak has cost American growers, processors, and retailers.

It’s time for Congress to step in and enact meaningful FDA reform legislation. Though time is short, Congress should act before another outbreak occurs to give FDA strong traceback authority, mandatory process control systems all the way back to the farm, and mandatory recall. The Bush Administration has consistently failed to put public health ahead of the complaints of industry lobbyists. Congress should not wait for more evidence that the agency doesn’t have the tools it needs.

CSPI, CFA: Emergency produce regs needed

If the tomato traceback investigation would have been solved in 10 days, we never would have seen this press release. As it is, the industry may well have to deal with new realities that only a month ago would have seemed far fetched. What's more, will "commodity specific" measures get lost in the rush? This news release from CSPI outlines the case for emergency produce traceability regulations. From the release:


Food safety and consumer watchdogs at the Center for Science in the Public Interest and the Consumer Federation of America are today making an urgent plea to Dr. Andrew von Eschenbach, commissioner of the Food and Drug Administration: Protect Americans from unsafe food by implementing emergency regulations requiring traceability for produce. The groups say that if fruits and vegetables can be tracked back up through the supply chain back to the farm, investigators would have an easier time nailing down the source of outbreaks of Salmonella, E. coli, and other dangerous pathogens.
“Effective traceability labeling must encompass the multiple steps along the path from farm to table, including farm-of-origin, packer, distributor, and retailer,” the groups wrote in a letter to von Eschenbach. “Such a system should use a standardized code for all FDA-regulated items to streamline investigations and ensure effective record-keeping by all entities along the production chain.”
Major players in the produce business already know how to use the basic technology needed for traceability: little stickers on fruits and vegetables. The industry already has standard price look-up codes, or PLUs, that retailers can use at the register. Tomatoes that bear a sticker with the number 4087 are red Roma tomatoes, for instance. But similar standardized codes could let retailers, food safety investigators, or even curious consumers know exactly what farm a given bunch of asparagus or bag of spinach hails from.
“Each outbreak causes huge losses, both for the consumers who become severely ill and for the growers, who often can’t sell their products,” said CSPI food safety director Caroline Smith DeWaal. “Unfortunately, as this investigation has dragged on, the produce industry is reaping what it sowed when it sought and received special exemptions that allowed the industry to avoid the country of origin labeling requirements Congress passed in 2002. While new requirements are scheduled to go into effect later this year, FDA needs to go beyond country of origin labeling and give public health officials the ability to trace produce from the fork back to the farm.”
Although the FDA and the Centers for Disease Control are casting a wider net to locate the food source responsible for the current Salmonella outbreak, CSPI says the public should still follow the FDA’s current advice which tomatoes to eat and which to avoid.
“If FDA had put a traceability system in place two years ago following the spinach outbreak, this current investigation might be moving more quickly,” said Chris Waldrop, Director of the Food Policy Institute at Consumer Federation of America. “This latest outbreak demonstrates very clearly the need for the federal government to quickly and easily trace an implicated food to its source.”
The letter from CFA and CSPI also urges the agency to require growers and packers to implement written food safety plans, similar to the hazard control plans that have proved successful in reducing bacterial contamination of fresh meat and poultry. CSPI has been encouraging the FDA to require such plans since 2006.
“Traceability is essential to a 21st century food safety system,” said House Energy and Commerce Committee Vice Chair Diana DeGette (D-CO). “It is possible to trace the origins of our foods. Most of our food products already have labels, many companies already know their suppliers, and the technology already exists. Unfortunately, we have a broken food safety system in this country that cannot determine the source of tainted foods while consumers continue to get sick. Traceability will allow us to quickly identify the source of contamination while protecting the American consumer and industry’s bottom-line.”
When distributors mix and match produce from different sources, a practice called “repacking” in the industry, they should be required to maintain the identifying marks or labels that would allow FDA to determine the origin, according to the food safety groups.
Since 1990, CSPI has tracked over 700 outbreaks of foodborne illness linked to produce items, including two dozen outbreaks linked to tomatoes that have caused more than 3,000 illnesses.
While 869 have been sickened in the current outbreak, foodborne illness is dramatically underreported, so the actual number of illnesses is likely many times higher. Today’s letter to von Eschenbach is signed by DeWaal, Waldrop, and CSPI executive director Michael F. Jacobson.

What's going on with the RSS feeds?

Well, I couldn't tell you, but it seems to be a system-wide problem for blogger today. You will find the RSS feeds I have on the right hand side of the column - Mulch, CSPI, USDA, Real Clear Politics, Heritage blog, Barfblog, etc. - are broken. I anticipate they will work tomorrow, just as I think the sun will rise. I'm a glass half full kind of guy, after all.

This may be a good opportunity for you to give me any feedback you have on the RSS feeds Fresh Talk features. What is your single favorite RSS link?

As for me, Mulch blog is the one I find going to most often, despite the fact Ken Cook infamously once called produce industry lobbyists the "cheapest date in town."

Food safety flurry

Here is the link to the Web page that links to today's hearing by the Senate Committee on Health, Education, Labor, and Pensions on "Developing a Comprehensive Response to Food Safety." The page also provides a link to view the hearing and links all the testimony offered. The "witness" list":

Witness Testimony

Panel I

The Honorable Michael Leavitt, Secretary, Department of Health and Human Services, Washington, DC
From Leavitt

Implementing the Import Action Plan and the Food Protection Plan will require resources, including reallocation of existing resources, as well as trade-offs, to fund these priorities. We plan to coordinate with Federal departments and agencies to carefully plan the implementation and submit funding needs through the normal budget process in February 2008 and in subsequent years. To the extent that additional statutory authority is needed to implement the Import Action Plan, we look forward to working with this Committee on import product safety legislation.

Panel II

Michael R. Taylor, Research Professor of Health Policy, The George Washington University, Washington, D.C.
From Taylor:

Congress should undertake a serious study of how to establish an adequate and stable funding base for FDA’s food safety program for the long-term. Just as it is fair to hold the food industry accountable for doing its food safety job, it is fair to hold FDA accountable for the leadership and effective action we expect from that agency, but only if it has an adequate and predictable resource base.

Paul Young, Ph.D, Senior Marketing Manager, Waters Corporation, Newtownards, N. Ireland
From Young:

It is clear that any food safety system which relies on voluntary compliance will be inherently risky, since even the very stringent systems employed by both the EU and Japan continue to give rise to a significant number of cases of violative food contamination (as published by each authority). Countries without unequivocal regulations governing the production of imported food run the risk of inviting the delivery of sub-standard products.

The Honorable Cal Dooley, President & Chief Executive Officer, Grocery Manufacturers Association, Washington, DC.
From Dooley:

Fourth, we urge you to take steps to continually improve the safety of food produced in the U.S. In particular, we urge you to provide FDA authority to mandate that produce be produced following good agricultural practices. Rising consumption of fruits and vegetables, including ready-to-eat foods, reflects growing consumer demand for healthier food choices but also creates new food safety challenges that should be addressed through strong and enforceable produce safety standards which can be tailored to reflect differences among commodities. Similarly, we support modernizing preventative controls for packaged food products to reflect scientific advances and thereby strengthen the foundational elements of our food safety system. We also support proposals to require facility registrations once every two years, as suggested in FDA’s Food Protection Plan, and we support increased frequency of facility inspections, provided that such inspections are based upon a scientific assessment of risk and upon history of compliance.


Caroline Smith DeWaal, Food Safety Director, Center for Science in the Public Interest, Washington, DC
Excerpt from Smith DeWaal:

FDA’s Food Protection Plan calls for several authorities that CSPI has long advocated, like mandatory recalls, and proposes changes to address shortcomings in the implementation of the Bioterrorism Act’s food facility registration program. But its shortcomings are numerous:
• It is not enough to ask for new authority to mandate recalls but fail to ask for authority to require traceability standards and impose civil penalties so that recalls are effective.
• It is not enough to require strict food security plans but fail to require food safety plans that would protect the public from the inadvertent contamination of food that annually sickens and kills so many Americans.
• It is not enough to identify a need for the full life-cycle approach to food safety but fail to ask for authority to implement programs on the farm or in the country of origin. In sum, the Food Protection Plan underscores the need for reform, but Congress must take stronger action if it is to ensure the safety of the food supply and protect Americans from preventable illnesses and deaths.

Joseph Corby, Director, New York Department of Agriculture & Markets, Albany, NY
From Corby:

The FDA Food Protection Plan and Action Plan for Import Safety are the latest efforts by the agency in setting strategies for protecting the nation’s food supply. These plans have great promise and both rely very heavily on working collaboratively with stakeholders including state and local agencies. The Action Plan for Import Safety speaks specifically for considering cooperative agreements with states. The Food Protection Plan uses less specific, more general language such as “collaboration with” and “working closely with” states in several areas of the document. In my opinion, FDA should strive to work more strategically with the states on a variety of functions including food safety inspections, food product surveillance, and imported food evaluations.

Still waiting and Harkin's amendment to update school nutrition standards

There is no definitive word on how the Senate will proceed with the farm bill, John Keeling of the National Potato Council told me this morning. Meanwhile, there continue to be some reports reflecting optimism about the chance for immediate Senate action, while other voices say it is not likely until the first quarter of 2008.

Meanwhile, Sen. Tom Harkin announced today that he has broad support for a planned amendment to the farm bill that will update nutrition standards of food sold in schools - outside of the school feeding programs. There is little detail in the news release about specific measures. From the office of Sen. Tom Harkin:

Harkin-Murkowski Amendment Will Update Decades- Old Nutrition Standards in Schools Nationwide

Amendment to be offered to Senate farm bill has broad support

Washington, D.C. – Senators Tom Harkin (D-IA) and Lisa Murkowski (R-AK) today announced that they plan to offer an amendment to the pending Senate farm bill to update decades-old nutrition standards in schools. The amendment, the result of months of negotiation with both the public health community and the food and beverage industry, seeks to establish appropriate school nutrition standards for foods and beverages offered in school vending machines, school stores and other venues outside of the school meal programs. The effort represents the broadest reform of foods sold in schools since the U.S. Department of Agriculture (USDA) first implemented nutritional guidelines in the 1970’s.

“Our amendment will improve the diets and nutrition of America’s school children by setting reasonable, common-sense standards for the foods and beverages that are sold in school vending machines and similar outlets,” said Harkin, Chairman of the Senate Committee on Agriculture, Nutrition and Forestry. “School sales of candy, snacks and soft drinks have gone way up in recent years even as more and more kids are overweight or obese or have chronic diseases such as diabetes. This is a dangerous equation for the health of America’s kids – now and in their adult lives.”

“A healthy population starts with healthy children – we must establish healthy habits and activities at an early age to prevent obesity and diet-related diseases later in life,” said Senator Murkowski. “This amendment is a step towards countering the youth obesity epidemic. The current standards for competitive foods sold in schools are out of date and do not include any of the current knowledge about the dangers of trans fats, high sodium, sugar and cholesterol and nutritional guidelines.”

The amendment has broad support from both the food and beverage industry and health and education groups including:

Coca-Cola
American Association of School Administrators
Nestle
American Cancer Society
Mars
American Dental Association
Frito-Lay
American Diabetes Association
General Mills
American Dietetic Association
McCain foods
American Federal of Teachers
Pepsi-Co
American Medical Association
Cadbury Schweppes
American Public Health Association
Dannon
Center for Science in the Public Interest
American Beverage Association
Consumer Federation of America
Kellogg
Food Research and Action Center
International Dairy Food Association
National Association of School Nurses
National Milk Producers Federation
National Education Association
National PTA

“If parents, public health advocates and industry can come together with these senators on a national standard, the rest of the Senate should be able to do the same and pass this important amendment promptly,” said Susan K. Neely, president and chief executive officer of the American Beverage Association.

“States have been strengthening their school nutrition policies. But after a decade of hard work, two-thirds of states have no or weak nutrition standards to limit junk-food and soda sales out of vending machines, school stores, and other venues outside of school meals,” said Margo G. Wootan, director of nutrition policy at CSPI. “We hope that Congress will listen to parents, health organizations, and the food and beverage industry and strengthen the national nutrition standards for school foods this year.”

“Our knowledge about the importance of nutrition and of nutrition itself has changed greatly in the 30 years since the standards for school foods were established,” said Jennifer Weber of the American Dietetic Association. “This amendment can help transform the nutrition environment in schools so that it is consistent with our knowledge of children's nutrition and health. It is simply responsible to students' well being to act now to review and update the nutrition standards for foods sold in schools across the nation.”

Since the 109th Congress, Harkin and Murkowski have introduced The Child Nutrition Promotion and School Lunch Protection Act, which is similar to the amendment announced today.

CSPI White paper gets nod from DeLauro

Here is a statement from Rep. DeLauro on the 20-page CSPI White Paper on food safety:

DeLauro
Statement on CSPI
Food Safety White Paper

Washington, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) issued the following statement about the white paper from the Center for Science in the Public Interest: “Building a Modern Food Safety System: For FDA Regulated Foods.” “CSPI has drafted a comprehensive document that serves as an excellent reference source for anyone who would question whether our food safety system is broken. CSPI also dispels the notion that food-borne illnesses in the U.S. are insignificant, and reminds us that significant work remains in ensuring the safety of our food supply. “The CSPI document also provides exceptional guiding principles for Congress as we move forward with plans to modernize our food safety system. Many of these principles are being incorporated into the new bill I am drafting– The Food Safety Modernization Act – that would implement a modern food safety system with mandatory recall authority, inspection authority, and science-based performance standards. “I am looking forward to working with my colleagues in Congress to move forward with the ideas in my new bill, and in the CSPI report. The current environment indeed gives me real optimism that reform of the food safety system can be accomplished soon and those of us in Congress should take advantage of this unprecedented opportunity.”

New online database by CSPI

A new online database is offered by CSPI: It is part of the group's continuing quest to "modernize" food safety laws, raise awareness of foodborne illness, add funding and inspection capacity to the FDA. From the Center for Science in the Public Interest.

The Center for Science in the Public Interest has tracked foodborne illness outbreaks -- events where two or more people become ill from eating the same food -- since 1997. The Outbreak Alert! database includes only outbreaks where both the food and pathogen have been identified and currently has information on 5,000 outbreaks that occurred between 1990 to 2004. For a summary of the outbreak data, see our latest Outbreak Alert! report.

Tomatoes and food safety

The Washington Post published an extensive piece by Goody Solomon on Aug. 22 about food safety and tomatoes. Here is the link passed along by K-State's Food Safety Network.

Ponder food safety, as we tend to these days, and tomatoes don't readily come to mind -- unless you are at the Food and Drug Administration, which launched a Tomato Safety Initiative in Virginia in July. The program will move to Florida during the fall growing season, with plans to reach other locales.
Its dual purpose is to find practices that might lead to contamination and devise ways to fix them. Twelve outbreaks with a total of 1,840 cases of food-borne illnesses linked to fresh and fresh-cut tomatoes have occurred since 1998, according to the FDA. Most were traced to Virginia's Eastern Shore and Florida, two major growing areas, and a few to Georgia, South Carolina, Ohio and California. Salmonella was the main culprit.

Under the initiative, teams of experts (from federal, state and local government; the produce industry; and a university such as Virginia Tech) visit farms and packing facilities to assess conditions such as water and animal proximity.
Because water can carry bacteria, investigators look at irrigation water, wells, chemical mixing procedures and the results of drought and flooding, said Jack Guzewich, a specialist in food-borne diseases at the FDA Center for Food Safety and Applied Nutrition.
"Animals can be anything from reptiles to birds and mammals -- the whole zoological garden," Guzewich said. "Feces get into land and water, and, in some cases, an animal comes in contact with the plant."
The expert teams have completed their Virginia visits. They went to more than 50 growing fields and three packing facilities. But the data have not yet been entered "to see to what extent patterns start to emerge," said Michelle Smith, an interdisciplinary scientist at the Center for Food Safety and Applied Nutrition. The information will help the agency decide the best regulatory approach, she said.
The produce industry applauds this effort. "It will provide the FDA a sense of what is going on
in the industry and provide the industry with input from the FDA directly on things to minimize risks and change practices," said David Gombas, senior vice president for food safety and technology at the United Fresh Produce Association.
In contrast, Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, faults the FDA's reliance on voluntary performance. The CSPI has petitioned the FDA to mandate on-farm food safety plans dealing with such factors as manure uses, clean water and worker hygiene.

TK: Here is the link to the FDA announcement on tomato safety initiative from June 12. Better to have the focus on this FDA initiative on tomatoes now rather than after a major foodborne illness outbreak.

Overseeing wholesale markets

What does strong federal oversight of produce safety look like at the wholesale market level? I'm not sure, but I have a feeling that the folks at the Center for Science in the Public Interest might have an opinion. I went to the CSPI site today to look for the testimony of CSPI at the FDA's produce safety hearing. I didn't find the remarks, but I did see the link to the March 25 Dateline report on the 7th Street wholesale market in L.A.

The video of the Dateline segment is featured on a CSPI page found here.

From NBC's Web site is this from the transcript of that feature:

Caroline Smith De Waal, a consumer advocate from the center for science in the public interest, says wholesale produce markets might be a weak link in the food chain.
Smith De Waal: Consumers aren’t really aware of all the people who might be touching produce on its way to their table.
Starting last fall, we went undercover with hidden cameras, at the 7th Street Market, where week after week, we found filthy conditions—like workers dumping trash wherever they pleased or picking up cucumbers off the sludgy ground, and selling them like they’re clean.
We found produce stored right next to the porta-potties and next to garbage dumpsters which are crawling with rats—rats that feast on the markets fruits and vegetables.
NBC (on hidden camera): Are there rats?
Worker: Oh big ones. Boy, they love it in here.
Jeff Nelken, a forensic food safety expert, found these conditions inexcusable.

Jeffrey Nelken, food safety expert: Rats carry disease. As they walk on top of the food or they take a bite out of it, they are leaving their bacteria and virus behind.

But this was perhaps the biggest health hazard we saw, water spilling out of pipes that smelled like raw sewage. The water was splashing right onto boxes of produce.
De Waal: The conditions in that market really look like turn of the century.

We took water samples from the market and had them analyzed at a lab. What did they find in that water touching fruits and vegetables? Extremely high levels of E. coli, fecal coliform, and listeria, which can all cause food poisoning—and can’t always be washed off.
So where does this possibly contaminated produce end up?

Later in the report...

Smith De Waal: Wholesale produce markets need to be inspected regularly... this is vital to ensure that conditions like this don’t exist in other cities.
The owner and manager of the 7th Street Market are now facing criminal charges for multiple health and safety code violations. A spokesperson for the market tells us they're surprised by the charges because they've cleaned things up.

TK: While it would be an unfair exaggeration to say wholesale produce markets of today resemble their "turn of the century" likeness, we all know markets that look like they came from the 1970s. How produce safety regulations touch the wholesale market - and what adjustments must be made - will be a compelling story line in coming years.

Left of Center for Science in the Public Interest

Yes, the Center for Science in the Public Interest could easily be seen by industry as a left-leaning, pro big governent advocacy group. Yet they are an important stakeholder in the debate about food safety. Along with Tom Stenzel, Caroline Smith DeWaal of CSPI testified in Madison at the field hearing of the Appropriations Committee, ag subcommittee.
Here is a link to her prepared remarks.

Here is one except:

Last fall’s produce outbreaks are just the latest symptom of an agency that is overwhelmed by responsibility, but lacks the staff and resources to function effectively. The agency responds to crisis after crisis rather than preventing them. Current FDA funding shortfalls have reached a critical level and budget cuts have left the agency with fewer inspectors, even as their workload continues to increase. In fact, since 1972 inspections conducted by the FDA declined 81 percent. Since 2003, the number of FDA field staff dropped by 12 percent and between 2003 and 2006, there was a 47 percent drop in federal inspections. 18 FDA’s food program has a current funding shortfall of $135 million, which an FDA budget official described as equivalent to a 24 percent budget cut. This means that many other parts of the agency’s responsibilities are just not getting attention – things like obesity, dietary supplements, and appropriate oversight of new technologies. Overall consumer confidence in FDA has plummeted. A Harris Poll has documented that those who thought FDA was doing an “excellent” or “good” job went from 61% in 2000 who to 36% in 2006. Equally important is the fact that the federal agencies’ food safety expenditures are disproportionate to the risk posed by the foods they regulate. USDA regulates 20 percent of the food supply, which causes 32 percent of outbreaks, yet its food safety appropriations are double.

TK: Though one can quibble at CSPI's call for a single food safety agency, I think DeWaal's arguments are convincing here for greater Congressional funding of FDA's food safety duties. Even so, her stated wish that the FDA would "prevent outbreaks" rather than respond to them perhaps reflects a tad too much faith in man made bureaucracy and too little respect for the resourcefulness of pathogens.