Ready for regulation?

Add the financial services sector to the list of industries looking for greater government regulation, says this report from MSNBC headlined "30 year deregulation era dies a sudden death."

The produce industry is mentioned prominently in this news report. Here is an excerpt from the MSNBC story:

Certainly, there have been plenty of scares in the past few years. A series of food poisoning episodes — notably, the salmonella outbreak that sickened about 1,500 people earlier this year — made consumers worry about the safety of the nation's food supply. What's more, it became clear that the Food & Drug Administration had no easy way to trace tainted food back to its source.
Those incidents resulted in a major turnabout in the food industry's view of regulation. It once loved the fact that the FDA didn't have the money or inspectors to scrutinize it. "The reduction in regulation has made things worse, and industry recognizes it," says William K. Hubbard, a former FDA associate commissioner. "I think they really became aware of their vulnerability."


For obvious reasons then - and made more clear with subsequent developments - the fresh produce industry was the first to embrace their fate. Here is what I wrote for The Packer on Jan. 29, 2007:

WASHINGTON, D.C. -- In 230 years of fresh produce growing and marketing in the U.S., there has never been a system of strong federal regulation of produce safety. That may be about to change. United Fresh Produce Association president Tom Stenzel on Jan. 23 told the Fruit and Vegetable Industry Advisory Committee that the 40-plus-strong United board on Jan. 20 voted unanimously to advocate federal oversight of clear and strong produce safety standards based on the best available science.
"We want mandatory regulation, and that's a big sea change for us," Stenzel said. He said United will reach out to all elements of the trade, as well as regulators and members of Congress to discuss the issue. The scope of the regulations became an immediate question. Stenzel said it's not intellectually honest to look at one part of the supply chain only. It makes better sense to go from farm to table and reduce the risk wherever it is. He said he doesn't know what that will mean for terminal market, foodservice or retail operations.
As for growers, all U.S. producers would be included under the regulatory umbrella. "If we don't have mandatory federal regulation across all growing areas, we don't feel it will meet the confidence of consumers, and that's something that is very clear," he said. However, regulations could vary, he said, with commodity-specific guidance where needed. "Clearly lettuce and leafy greens are in the bull's-eye, but our board feels strongly that everyone is losing public confidence with every outbreak," he said.
Maureen Marshall, co-chairwoman of United Fresh and vice president of Torrey Farms Inc., Elba, N.Y., said the board felt the industry would have more input by taking the lead. "We know that the FDA wants to see something happen," she said. "I'd rather see us direct the process than have them give us something. … All the people, from large to small , the feeling (on the board) was the same."
Reaction to the United Fresh board decision was mostly supportive, although many industry leaders thought the issue needed more deliberation. "They sent us a copy of the letter, and it's a positive step," said Nega Beru, director of the Office of Plant and Dairy Foods and Beverages at the Food and Drug Administration's Center for Food Safety and Applied Nutrition. Beru said the agency was planning a couple of hearings on produce safety in the near future. No date has been set for the meetings, but he said they would be the venue to explore issues like commodity-specific guidelines and concepts of farm-to-table regulation.
He did note, however, that the Centers for Disease Control and Prevention says a select number of commodities account for the majority of foodborne illness outbreaks, suggesting that different standards could be place for different commodities. Relative to inspection of foreign farms, Beru said the FDA has conducted inspection at foreign farms, but typically in conjunction with trained personnel from regulatory authorities of those countries or using only those foreign personnel.
Kathy Means, vice president of government affairs for the Newark, Del.-based Produce Marketing Association, said that group's executive committee was to meet Jan. 27-28. "As we have said all along, we will side with what's necessary to bring confidence in produce for consumers and buyers." Tim York, chief executive officer of Salinas, Calif.-based Markon Cooperative Inc., said United's plan was bold, but he cautioned against overreaching by trying to include wholesalers and retailers. Grower-shippers should be where regulations start, and then later efforts would address each sphere of the supply chain sphere, York said. "Otherwise, we've got a battle on our hands with pretty powerful lobbying interests of retail and foodservice that could come up against that idea."
Matt McInerney, executive vice president of Western Growers, Irvine, Calif., said federal oversight can be complementary to California's work on a marketing agreement for leafy greens.
"There is life outside of California," added Mike Stuart, president of the Florida Fruit & Vegetable Association, Maitland. "Before we get too far down the road, we need to bring the industry together to talk about this."
One Northwest U.S. industry leader stressed that growers need to sort though the issue. "In 200 years, there has been no federally mandated food safety system in the industry in the grower-shipper chain, and to call for that is an incredibly huge deal," said Chris Schlect, president of the Yakima, Wash.-based Northwest Horticultural Council. "It will require more thought."
"I'm not prepared to pass judgment on it quite yet," added John McClung, president of the Mission-based Texas Produce Association. "It's a huge step for the industry." McClung said the call for federal oversight makes the controversy over country-of-origin labeling seem puny in comparison. "My concern is that the grower-packer voice not be lost in the shuffle," he said. A meeting of United's government relations council in mid-February may be an opportunity for more discussion among industry groups, Schlect said. Another concern is whether federal regulation is the appropriate response. "It might be the right decision, but it's a concern that a lot of the leafy greens issues in California are driving the food safety program for all of American agriculture and the produce industry," he said.

The United Fresh Produce Association says oversight must adhere to the following four principles:
* Standards must be consistent and applicable to all produce grown anywhere in the U.S. or imported into the U.S.
* Standards must be mandatory, with sufficient federal oversight in order to be credible to consumers.
* Standards cannot depend upon marketing programs or voluntary certification, although these programs can be helpful.
* Standards must allow for commodity-specific food safety practices based on the best available science.
Source: United Fresh Produce Association


TK: Both Republicans and Democrats are moving toward regulation, or reregulation, as opposed to deregulation. The loudest voices in the produce industry still wants regulation:

Greg Murray, a tomato grower from Georgia, told the House agriculture appropriations subcommittee this week this in a prepared statement:

"I ask for you to take swift action to pass a mandatory food safety program nationwide based on commodity risk that will insure our food supply is safe," Murray said.

If the entire industry is not "on board" with the idea of increased food safety regulation, they are certainly keeping quiet about it.

Yes, it is regulation that industry wants - both United and PMA - and that both parties seem prepared to embrace. The industry caveats remain, of course; the regulations must risk based, science based, commodity specific, providing the greatest consumer protection, flexible to account for regions, harvest and packing practices and applying to both domestic and imported fruits and vegetables.

Does the industry expect Congress - or even the FDA - create a list of "high risk" commodities that will meet industry satisfaction? How do you cut off that list? Is the 6th commodity appreciably more risky than the seventh?

Is asking for science-based regulation even realistic given the paucity of hard research about pathogen risks throughout the supply chain?

The Cornucopia Institute has filed a suit against the federal marketing order for almonds based on its pasteurization requirement. How will small farms and organic farms respond to greater regulation by Congress, the FDA or USDA marketing orders and agreements?

We continue to wait on how much regulation will be industry led and how much will be mandated by Congress or the FDA. For example, we are still waiting on a press release from the Produce Traceability Initiative describing their timeline for industry adoption of traceability standards.

Strong-willed members of Congress are working on delivering food safety reforms within the next year. The good news is that produce industry lobbyists are actively engaged with those lawmakers to shape the language of food safety regulation. The sobering news, perhaps, is that the industry is counting on government to fix a problem that it couldn't fix itself.

Testimony - Jeff Levi

Here is the link to the testimony by Jeffrey Levi, Executive Director of Trust for America’s Health (TFAH), speaking at the House agriculture appropriations subcommittee hearing on the salmonella outbreak yesterday. Not much new here; the FDA is archaic, underfunded and slow to develop a strategic vision matched with resource requests. Here is one excerpt:


Our report finds that Congress has not provided the Food and Drug Administration with a modern, public health mandate to prevent foodborne illness; has not updated the agency’s legal tools to meet the challenges of a high-tech, globalized food supply; nor has it provided the funding stream necessary to carry out research and inspection. At the same time, the agency has not adequately expressed its resource needs as it moves forward with its Food Protection Plan.

Michael Taylor - testimony

Go here for the Sept. 17 testimony of Michael Taylor before the House agriculture appropriations subcommittee. What the system lacks, Taylor said, are these elements;


Focused Federal Leadership and Accountability – FDA, the centers for Disease Control and Prevention (CDC) and the Department of Agriculture (USDA) (when meat and poultry may be involved) each play important roles in multi-state outbreaks, but no single federal agency or official is clearly in charge and accountable for the overall management of the effort.
Well-Defined Institutional Roles – Federal, state and local agencies necessarily collaborate on multi-state outbreaks, but the collaboration is essentially ad hoc: there are no formally established mechanisms or protocols for such collaboration or even clarity about when responsibility for managing an outbreak properly shifts from the state or local level to the federal.
Necessary Expertise and Capacity – The expertise and capacity of state and local agencies vary widely, and, in general, due to chronic under funding and lack of sufficient staff dedicated to outbreak investigations, capacity at all levels of government is thin.
Effective TracebackSystems– There is no effective system for ensuring rapid government access to critical traceback information, which places extra burdens on already strained resources and delays investigations.
Seamless Data Collection and Sharing – There are no standardized approaches to collecting and analyzing epidemiological data, which undercuts the scientific foundations of a multi-state investigation; and conflicting interests and policies often obstruct the flow of information among agencies that should be operating as a cohesive team in managing a multi-state outbreak.
Industry Engagement – There are no established mechanisms for tapping the expertise of the food industry on such matters as industry structure, practices, and distribution patterns, which could both expedite and improve the accuracy of investigations.
Coordinated Public Communication – The lack of clarity about who is in charge of an investigation can result in lack of clarity in communicating with the public, as information about an outbreak is commonly made available from multiple government sources.

Testimony - Tomato grower Greg Murray

Find the statement of Georgia tomato grower Greg Murray here from the Sept. 17 hearing on this year's salmonella outbreak investigation by the House agriculture appropriations subcommittee. Here is an excerpt, recalling some of the more painful moments for growers:

We are appreciative FDA established a list of ‘safe states’ that were identified as not being a part of the outbreak and tomatoes from those states were safe to consume. Georgia was included on the very first ‘safe list’ but most consumers were afraid of any kind of tomato. Each day the CDC and FDA were announcing more salmonella cases had been reported. The messages were confusing. Consumers could not understand the reported salmonella cases were from product consumed three to five weeks ago, not product currently on the market. So the safest thing for a consumer, or a food outlet, to do was just not purchase or consume tomatoes.

Over the next four weeks tomato sales and prices at Murray Farms dropped to almost non-existent. We left half of our crop in the field because we could not sell it. For those tomatoes we could sale, the price dropped to as low as $2.00 per box rather than a normal year at more than $12.00 per box.

The fact that Georgia tomatoes were never implicated as having a problem, did not matter. With prices at $2.00 a box, we finally threw in the towel and left over 1.5 million pounds of tomatoes in the fields to rot. This many tomatoes would have fed 90,000 Americans for a year.

This incident has been a severe financial hardship to our farm. We expect to lose over $2 million of income, not profit, due to this food safety scare. This $2 million loss is money that we need to pay for our production costs such as, mulch, fertilizer, pesticide, irrigation and labor to harvest those acres we did pick.

In addition to the loss of income to our farm, one of our main concerns is the loss of consumer demand for tomatoes this fall and next spring. We have reduced our fall crop by 50% for fear the consumer will not return to tomatoes in the fall.

Later, Murray gave recommendations to the subcommittee.....

I am here today because I want to be a part of the solution. I hope the information offered in my testimony will help this sub-committee address this serious problem and keep another ‘false food safety awareness fiasco’ from happening again. The following recommendations are offered to this subcommittee and supported by the Georgia Fruit and Vegetable Growers Association:

1. First, I ask for you to take swift action to pass a mandatory food safety program nationwide based on commodity risk that will insure our food supply is safe. To restore consumer confidence, it is critical to the entire produce industry that FDA adopts such a mandatory policy for tomatoes and other produce, based on the risk factor for that product. Any guidelines should take into consideration regional production differences, product risk levels, and not be a one-size-fits-all. In addition FDA must look to the industry for input and consultation in the development of these policies.

2. Second, I ask you to require FDA to develop a plan of action that demands state and federal agencies to work together with industry so their future responses will not become another ‘false food safety awareness fiasco’. FDA should put forth a plan detailing how agencies and industry can work together and prevent another economic disaster like this last Salmonella saintpaul outbreak. Such cooperation would have been helpful back in May, June and July when tomatoes were the false target. In order to move quickly to solve the problem and identify the illness source, full cooperation with a transparent process must be developed in advance of future outbreaks. A model could be the Investigation Team at an airliner crash site assembled by the National Transportation Safety Board. No public statement is made until the ‘cause of the crash’ has been determined.

And thirdly, I ask for swift passage of HR 6581 which will partially compensate farmers for some of their losses due to the food safety scare caused by the federal government. We believe Congress should provide relief to growers and shippers in Georgia for the real losses we suffered and we will continue to suffer at no fault of our own. We believe we are in the same situation as growers of other commodities whose crops were destroyed by a natural disaster.

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.