Harkin: effective traceback needed

Sen. Tom Harkin makes a strong statement, with many points of his long letter in support of industry concerns expressed over the past several weeks. The question is now: what will "effective traceback" look like? From the office of Sen. Tom Harkin:

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

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

“Each food-borne outbreak seems to be larger than the next, and in this case, over a month has lapsed and the origins of this case are still unknown,” said Harkin. “The victims of this outbreak are growing by the day and don’t know what food made them sick because the source of contamination remains a mystery to the Food and Drug Administration. How do you tell over 1000 people we don’t know what made them sick?

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

The full text of the letter follows.

July 15, 2008

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

Dear Secretary Leavitt:

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

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

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

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

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

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

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

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


Sincerely,



Tom Harkin
Chairman

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

FB: On board for offshore drilling

From the Farm Bureau today.


President Bush’s lifting of the executive moratorium on offshore oil drilling that has been in effect since 1990 was welcome news to the American Farm Bureau Federation.

“Farm Bureau supports exploration and development of domestic supplies of fuel,” said AFBF President Bob Stallman. “America’s farmers and ranchers want to see us do more as a nation to use the resources at our disposal.”

The move by Bush puts pressure on Congress to lift its ban on offshore drilling, which would boost domestic oil and gas supplies down the road.

“Simple economics tells us that more supply will bring down prices,” explained Stallman. “Although it will not provide immediate relief, development of OCS resources needs to be part of our overall national energy policy.”

Farm Bureau envisions an effective national energy policy with multiple provisions.

“Our national energy policy must support renewable resources such as wind power, ethanol, and other biofuels, in addition to energy resources found in the OCS and Alaska,” said Stallman. “This is an important part of what we need to do as a nation to benefit all citizens, not just farmers and ranchers.”

Farm Bureau continues to press Congress to lift its ban on offshore oil drilling.

Gas at $40/gal = Slim Jim

The more gas prices rise, the less obese we will become. The silver lining has been there all the time, but our double chin obstructed the view. Here's the scoop: Rising Gas Prices Could Cure Obesity. From the story:


Courtemanche says a $1 increase in the price of gasoline could cut the obesity rate by 10 percent, saving 16,000 lives and $17 billion in health care costs each year. He makes the case in "A Silver Lining? The Connection Between Gasoline Prices and Obesity," his doctoral dissertation in health economics. The paper, currently being peer-reviewed, can be summed up in the simple idea that people walk more, bike more and dine out less when gas prices rise.
Evidence suggests he's on to something.
Courtemanche compared 20 year's worth of government health surveys to fuel prices. The percentage of American adults considered obese doubled to nearly one-third between 1979 and 2004, and Courtemache says 8 percent of the increase can be attributed to low fuel prices. "Cheaper gas during that period made us fat," he told Wired.com. "Presumably, the opposite would be true."

TK: He's right, of course. The classic good news/bad news bit... gas is $14 per gallon but you are finally losing weight. Where would we be without American optimism?

Maybe this will help consumers remember to bring their canvas bags to shop with

One of the amusing things about the trend of "green" shopping bags at grocery stores (gleaned this nugget from the FMI Sustainability Summit last month) is that consumers love to buy the "green" canvas grocery bag but they often forget to bring it back to the store and shop with it. Perhaps they used it for suntan lotion or what have you, but some consumers just don't make the connection that the point of a "green" bag is to use it again and again at the market. Maybe a "green" tax on paper or plastic will help us remember; along that line, here is a story about a city contemplating a tax on paper or plastic grocery bags. From the story in The Ballard News Tribune:


Paper or plastic? Beginning in January either choice could cost you.The City Council's committee decision on a proposal to tax all disposable shopping bags is scheduled for July 22. If approved by the committee and later by the full council, Seattle consumers would be charged a 20-cent "green fee" on each paper or plastic shopping bag they use in grocery, drug and convenience stores.The proposed legislation, expected to take effect on Jan. 1, would also ban the use of expanded polystyrene, more commonly known by the brand name Styrofoam, in all restaurants, cafeterias and grocery stores.The bill was designed to encourage shoppers to switch to reusable bags, reduce litter and diminish garbage land filling.


TK: It seems a little draconian to saddle paper with a green tax too. Why not tack on a surcharge for driving an SUV to the supermarket?..Wait, that's on next month's city council agenda....

July 14 CDC update and seeds of doubt

Here are the latest statistics from the CDC Website and headlines from the consumer press about the outbreak.


Since April, 1148 persons infected with Salmonella Saintpaul with the same genetic fingerprint have been identified in 42 states, the District of Columbia, and Canada.

Among the 804 persons with information available, illnesses began between April 10 and July 4, 2008, including 348 who became ill on June 1 or later. Many steps must occur between a person becoming ill and the determination that the illness was caused by the outbreak strain of Salmonella; these steps take an average of 2-3 weeks. Therefore, an illness reported today may have begun 2-3 weeks ago.

Health officials have worked continuously since late May to investigate this outbreak. CDC has sent 28 people to the field to work with other public health officials. The investigation is complex and difficult. One difficult aspect is that people often have difficulty remembering exactly what foods they ate, and remembering specific ingredients in those foods is even more difficult. Although laboratory testing of foods might help identify the source, perishable foods that were consumed by ill persons are often not available to test. When food items are mixed together and consumed in the same dish, all the items may be statistically linked to illness. In that case, determining by statistical means which item caused the illness can be difficult or impossible. Tracing suspect produce items back to processors and growers is an integral part of the effort to identify a single source and a possible means of contamination.



From the Web:

Seeds of doubt sown in salmonella case

Team to demand U.S. clear Mexican tomatoes of salmonella

Fruits & Veggies More Matters - Topping 1,000

I think the Produce for Better Health Foundation's Fruits & Veggies More Matters campaign is a remarkable PR generating machine. It seems that not a day goes by that I don't see a story - captured by Google news alerts scanning for f/v news - about the benefits of eating a colorful variety of fruits and vegetables or some other facet of the More Matters campaign. Kudos to the staff at PBH whose work is sometimes taken for granted by produce traders distracted by less happy news.

This morning I saw another example of the steady drumbeat of coverage PBH generates, published on Market Watch online. A sampling:


WILMINGTON, Del., July 14, 2008 /PRNewswire via COMTEX/ -- Logo Helps Moms Make Healthy, Informed Purchases
WILMINGTON, Del., July 14 /PRNewswire-USNewswire/ -- Moms shopping for healthy options can now find the Fruits & Veggies--More Matters(R) logo on over 1,000 different food labels in stores nationwide. To carry the Fruits & Veggies--More Matters logo, food products must meet strict nutrition guidelines for total fat, saturated fat, trans-fat, added sugar, fiber, and sodium content. Consumers can look for the logo when shopping as a designation that a product is nutritious and to remind them to eat more fruits and vegetables for better health. Healthful habits, like eating fruits and vegetables, may help lower the risk of obesity and other related diseases such as diabetes and hypertension.
Retailers, growers, packers and manufacturers across the country support the importance of fruit and vegetable consumption by including the Fruits & Veggies--More Matters logo prominently on both nationally marketed, brand name products, like those from Green Giant, Sunkist, Welch's, and others, as well as on the private label products of several grocery chains. A&P is the latest grocery retailer to have some of their private label frozen and canned fruits and vegetables approved to include the Fruits & Veggies--More Matters logo on their packaging. Other retailers featuring the logo on a number of select items from their private label line include: Bi-Lo, Kroger, Meijer, Publix, Safeway, Schnuck's, SuperValu, Ukrop's, Wal-Mart, and Weis.
"When you see the Fruits & Veggies--More Matters logo on a package of frozen, canned, 100 percent juice, dried, or fresh-cut fruit or vegetables, you know we've already done the label reading for you. It makes purchasing decisions easier," said Elizabeth Pivonka, Ph.D., R.D., president and CEO of PBH, the nonprofit entity who, together with the Centers for Disease Control and Prevention (CDC), is behind the Fruits & Veggies--More Matters health initiative.

The bus

On a morning like today I have to remind myself there are things I like about riding the bus. I barely made it to the bus in time, with razor cuts and semi-assembled clothes. And somehow – it wasn’t really that hard - I had misplaced my bus pass and forgotten my lunch.
I have been riding the bus on a more or less regular basis to The Packer offices this summer.
With about a 12 mile plus trip and gas at over $4.10 per gallon, a one way trip to my office would cost me (you do the math), not counting the ominous “wear and tear” on the car. Plus, “the Jo” (our bus system in Johnson County Kansas) eliminates the temptation of going home for lunch, which doubles the gasoline expense on days I exercise that option with my car.
On the other hand, my bus fare is just $1.50 each way. Plus, the way our summer is going at the home front, we have more drivers than cars.
One thing I don’t like about the bus is that it not a “sweet ride.” The bumps, rattles and jolts make it pretty hard to sit back and relax, much less steady a laptop on put one word after another during the 30 minute route. Another thing: no CD or radio to ease you into the morning with some Beach Boys tunes or mindless sports chatter.
A bitter and uncompromising reality is that the bus schedule is unforgiving. It doesn’t give you another 10 minutes if you hit the snooze button, or if you can’t find your bus pass, or if you haven’t eaten breakfast, packed a lunch, etc, etc.
Still, there is more to like than not.
The people on the bus are an easy going lot. Though I don’t know many of them by name, they are friendly one and all. And you get to know their story, little by little. One bus driver served as a helicopter pilot in Viet Nam and Iraq and is reading a fat book about the history of the Mormon religion. One 78 year old man is helping to paint a house to help him stay busy after the death of his wife of 52 years a couple of weeks before. Another young woman is from a small town in northwest Kansas where my son’s best friend is from. And so on.
So I will ride the bus, and even today, find reasons to like it.

What GAO found

From the summary page of the GAO report about international food safety systems:



The countries GAO examined have a comprehensive approach to ensuring the safety of imported food. Specifically, they focus on the entire food supply chain, from "farm to table;" place primary responsibility for food safety on producers; separate risk assessment and risk management; use a risk-based inspection system; and take steps to ensure that certain food imports meet equivalent safety standards. Under the farm-to-table approach, for example, food safety laws cover every stage of the food production process, starting with how animals are raised and ending when food reaches the consumer. All countries GAO reviewed focus import inspections on the foods likeliest to pose the greatest risk. The EU, for example, requires that all imports of live animals and products of animal origin—which are considered high risk—enter the EU through approved border inspection posts.
Several of the selected countries reported that three elements of their food safety systems are critical in helping them respond to outbreaks of foodborne illness. These elements are traceback procedures, cooperative arrangements between government veterinarians and public health officials, and mandatory recall authority. In EU member states, all food must be traceable "one step forward and one step back" so industry and government can quickly track any food products to minimize harm to public health and reduce the economic impact on industry. Food and feed business operators must be able to document the names and addresses of the supplier and customer, as well as the nature of the product and date of delivery. Officials in several countries told GAO that mandatory recall authority—the legal authority to remove, or require another party to remove, a product from the market—is rarely used but is an important part of the food safety system because it is the last stop in the supply chain.
None of the selected countries had comprehensively evaluated its reorganized food safety system, although several track certain indicators, such as the number of inspections, enforcement actions, and foodborne illness. However, some countries’ national audit offices (GAO’s counterparts) have evaluated specific aspects of their countries’ systems. For example, the UK audit office found that the country’s Food Standards Agency had improved public confidence, a stated objective. The EU’s Food and Veterinary Office has conducted numerous reviews of aspects of all EU countries’ food safety systems and identified areas needing improvement. Most of the selected countries use proxy measures, such as public opinion surveys, to assess their effectiveness. Public opinion in several countries has improved in recent years. Countries’ industry and consumer stakeholders also generally had positive views of the reorganized food safety systems.
Experts identified food safety challenges that they expect to face over the next decade. These include climate change; demographic change, with increases in elderly people and immigration; and new types of foods, such as ready-to-eat salads, that may result in more incidents of foodborne illness.

The argument for a single food safety agency

A new GAO report looks at foodborne illness outbreaks from countries with a single food safety agency. From the office of Rep. Rosa DeLauro:


U.S. Senator Dick Durbin (D-IL) and Congresswoman Rosa L. DeLauro (CT-3) today unveiled a Government Accountability Report (GAO) report examining foodborne illness outbreaks in countries with a single food safety agency. The report comes as the Food and Drug Administration (FDA) continues a three-month investigation to determine whether tomatoes or jalapeños were the source of a salmonella outbreak, which sickened more than a thousand people . Durbin and DeLauro requested the report following a 2006 E. coli outbreak involving pre-packaged spinach (to view the request letter, please click here).

For two consecutive Congresses, Durbin and DeLauro have introduced The Safe Food Act (S. 654 and H.R. 1148 in the Senate and House respectively), which would consolidate all food safety activities into a single agency, responsible for the administration and enforcement of our food safety laws. Importantly, when enacted, it would create a national system for tracing food, point-of-origin to retail sale, which would have aided the investigation into the still unknown source of the current salmonella. Currently, there are at least 12 different federal agencies and 35 different laws governing food safety. With overlapping jurisdictions, federal agencies often lack accountability on food safety-related issues.

“This GAO report highlights how effectively a single food safety agency could protect our food supply. The findings in the report offer us in Congress important lessons on how to proceed with food safety reform legislation. Not only does the report outline the critical components that are necessary for an effective food safety system – traceback procedures, cooperative arrangements between public health officials, and mandatory recall authority – it also demonstrates that these measures can be implemented seamlessly under a system governed by a single food safety agency,” said DeLauro. “We must incorporate the philosophy used by the countries featured in the GAO report. By focusing on the entire food supply chain, placing primary responsibility for food safety on producers, and ensuring that food imports meet equivalent safety standards, only then could Congress adequately reform the U.S. food safety system.”

"Today's GAO report shows that America ranked eighth out of eight countries -- dead last -- in terms of national food safety systems. Why? The other countries studied have integrated food safety systems. Our practice of making piecemeal changes to outdated laws is simply ineffective," Durbin said. "I hope today's report serves as a wake-up call for the Administration and others in Congress. We need a thoughtful overhaul and reorganization of America’s food safety system. These changes don’t have to happen all at once. But they need to start now. "