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Food For Thought: An Interview With Joseph A. Levitt

by Raymond Formanek Jr.

Americans enjoy one of the safest food supplies in the world.

Despite that fact, diseases caused by food in the United States are responsible for an estimated 76 million cases of gastrointestinal illnesses, 325,000 illnesses resulting in hospitalizations, and 5,000 deaths each year, according to the Centers for Disease Control and Prevention.

As director of the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN), Joe Levitt is responsible for directing programs aimed at ensuring the safety of the nation's food supply. Under Levitt's leadership, CFSAN is responsible for a wide range of other programs, including food and color additives, food and nutrition labeling, dietary supplements, and cosmetics.

Levitt and the nearly 900 CFSAN scientists, researchers, regulatory personnel, and support staff oversee products that account for nearly 80 percent of what Americans spend on food. Levitt recently discussed food safety and other current topics such as bioengineered foods and imports with FDA Consumer.

Q: Food safety remains a top priority with the Center for Food Safety and Applied Nutrition. What are the major accomplishments in the center's food safety program? Where are the center's food safety resources focused?

A: When I first took this job three and a half years ago, I said our top priorities would be: food safety, food safety and food safety. If you compare where we are today on food safety to just three or four years ago, you will see that we've made fundamental changes that increase consumer protection.

Food safety is a compelling public health issue. As part of the Department of Health and Human Services (HHS), the FDA's food safety programs affect every American, every single day.

The FDA and the Centers for Disease Control and Prevention (CDC) within HHS, along with the U.S. Department of Agriculture and our state and local counterparts, have worked to significantly strengthen the food safety system in the United States. Together, we have implemented stronger prevention programs, new surveillance systems, faster outbreak response, risk-based research and risk assessment, and expanded education programs.

Virtually everything we do in the food safety program has a strong scientific underpinning. We work hard to make our policies data-driven and science-driven so that they stand the test of time. Our credibility comes, in large part, from the fact that objective, scientific evidence will lead us in the right direction.

Prevention is the foundation of our food safety program. The FDA has put several new prevention programs in place. We now have prevention programs for seafood, juice, fresh fruits and vegetables, and sprouts, and we are developing one for eggs. But, we also realize that prevention efforts will never be able to eliminate all diseases caused by food. Therefore, with our federal and state partners, we've put into place a much faster and more effective system of early detection and containment that we call "outbreak response." If there is an outbreak of foodborne illness, we now are able to jump on that case much more quickly--much more effectively--and save lives.

Probably the single most significant scientific achievement in food safety over the last five years is something that's referred to as DNA fingerprinting. What that means is we now have the scientific tools to take a sample from one patient, and see if the bacteria's DNA "fingerprint" matches that of another patient, or food, to identify a common source of infection. In other words, DNA fingerprinting speeds the "detective work" to determine when an outbreak has occurred. This enables us to more quickly respond to the outbreak, and prevent more people from getting sick. DNA fingerprinting is literally saving lives. The CDC has been instrumental in converting this new technology into a nationwide surveillance system called "Pulse Net."

In terms of resources, we have redirected our entire field inspection force to really focus on those food products that present consumers with the greatest risk for contamination with potentially harmful bacteria. Starting this year, we are conducting annual inspections of every company in the United States that makes one of these high-risk products so that we can ensure that prevention procedures are adequate and in place. This same strategy applies to imported food that arrives at U.S. borders. We conducted a survey of 1,000 samples of imported fruits and vegetables to identify which products were at highest risk for contamination. We then targeted our border surveillance to those high-risk products. We are now following up with a similar survey of domestic fruits and vegetables to help target our efforts inside the United States.

The bottom line is we are focusing on the highest risks, and we are targeting our efforts to be sure that we have them focused on where they do the most good for the American consumer.

Q: Despite the stringent measures already taken to protect people and cattle from "mad cow disease," some say that more needs to be done to keep nervous system tissue from affected cattle out of the U.S. food supply. Is the FDA considering additional steps to ensure that foods remain free from prion contamination?

A: While we have no evidence that bovine spongiform encephalopathy, commonly called "mad cow disease," is in the U.S. cattle herd, all of us must stay vigilant to be sure that we keep it out of this country, if at all possible. Starting seven years ago, the FDA put in place a series of programs that are designed to help minimize the risk of mad cow disease entering the United States. Over the past year, we have been getting reports from around the world that the disease has spread into some countries where it hadn't been found before. We, like virtually every other country in the world, are taking another look at all our programs to see if there are any new safeguards we need to put in place based on this new information.

We continue to work hand-in-hand with the U.S. Department of Agriculture to ensure that those guarding our borders have a complete listing of any food, supplement, or cosmetic products that may need to be screened before coming into the country. In addition, we continually re-evaluate our regulations to see if there are areas that can and should be strengthened. The bottom line is we want to take any steps that we can and should take to ensure that mad cow disease stays out of this country and out of any of our foods, supplements, or cosmetics.

Q: Despite persistent concerns about bioengineered crops, they are spreading so rapidly that it has become nearly impossible for consumers to avoid them. What steps is the FDA taking to ensure that bioengineered foods and animal feeds are as safe as their conventional counterparts?

A: The issue of bioengineered foods certainly has captured the public's attention over the last couple of years. In fact, there was so much interest that the FDA decided to hold three public meetings around the country on this issue. I chaired one of those meetings and we got a lot of feedback from them. I think the bottom line is that the public wants to make sure that the government is looking out for them and scrutinizing these products to ensure their safety. That's a legitimate issue. What we've done at the FDA is gone back and looked at our processes in light of that feedback.

In doing so, we decided to make changes that would further strengthen our program. Earlier this year, we proposed stronger regulations for food derived from biotechnology that would do two basic things: First, these regulations would require that all new foods derived from biotechnology be reviewed by the FDA before they go on the market. While this has been occurring on a voluntary basis, we want to be sure that the public has confidence in knowing that this will be a legal requirement, and that the FDA will ensure that any bioengineered foods are as safe as their conventional counterparts. Second, we proposed to increase the openness or transparency of the process so that consumers would have more access to what products we are reviewing, what safety data has been submitted on these products, what decisions we are making, and the reasons behind the decisions. That proposal has had a public comment period, and we are now evaluating those comments and developing final regulations. I believe that stronger regulations for bioengineered foods will ensure that consumers have continued confidence in the safety of the U.S. food supply.

Q: The FDA recently issued a health alert suggesting that pregnant women and women of childbearing age avoid four species of fish--swordfish, king mackerel, shark and tilefish--because of potential methylmercury contamination. Fish and seafood are an important part of a healthy diet. What steps have been taken by the FDA to ensure seafood is safe to eat?

A: The first prevention program put into place by the FDA was aimed at seafood safety. It's called Hazard Analysis and Critical Control Point or HACCP (há-sip). HACCP focuses on identifying and preventing hazards that could cause foodborne illness rather than relying simply on spot-checks of manufacturing processes or end-product testing. What this means is that seafood processors need to evaluate their systems and see where the real sources of contamination are. They should ask themselves: What are the potential hazards? Where are the "critical points" that need controls to limit those hazards? Then they must put in place a monitoring program to ensure that the hazards are, in fact, being properly controlled.

HACCP is the cornerstone of our science-based, modern food safety system. It actually is based on a system developed for NASA to ensure safe food for astronauts. After the FDA put in place HACCP for seafood, the U.S. Department of Agriculture implemented a HACCP program for meat and poultry. And the FDA is putting HACCP in place next year for juice products. So this really is the cornerstone of a modern prevention system. That's the overview.

Now, what have we done recently? What we have found is, as with any program, it's good to start looking at the big picture--but then you've got to start homing in on where the biggest problems are. This year we issued what we called a "mid-course correction" to our seafood HACCP program. We wanted to be sure we were devoting our time to those seafood products that potentially--and I emphasize potentially--could create the most serious health problems for consumers. Those are seafood products that could contain either harmful bacteria or histamines that cause allergic-type reactions. We want to be sure we inspect processors of the "high risk" products more intensely and make sure they have adequate HACCP systems in place.

We also are focusing on areas where particular groups of consumers may be vulnerable. Along these lines we issued an alert this year for pregnant women and women of childbearing age who may become pregnant to avoid four kinds of seafood: shark, swordfish, king mackerel and tilefish. Those are the fish with the highest levels of methylmercury, a naturally occurring marine toxin. A steady diet that contains foods with high levels of methylmercury could have harmful effects on an unborn child. We're taking a "better safe than sorry" approach here. And we've tried to get a strong warning out to women who are pregnant, and to women of childbearing age who may become pregnant, to avoid these kinds of fish to protect their unborn children.

Methymercury is a good example of how the breadth of the FDA's food safety program is expanding. While our food safety program over the last several years has focused on foodborne illness associated with bacteria, we are expanding the program to address chemical, environmental and physical hazards, as well. Typically, these hazards tend to be of a more chronic nature than bacterial hazards, but they are still very important.

Q: Imported foods, everything from Swiss chocolate to fresh produce from South America, continue to flow into the United States at ever-increasing rates. How does the FDA ensure that such foods are wholesome and of the same quality as domestically produced products?

A: Our goal in regulating imported foods is clear. We need to ensure that the consumer has the same level of protection and the same level of confidence in the food they eat, wherever its origin. A consumer shouldn't have to try to figure out which sources of food are safer than others. That's the government's job.

First, we need to realize that imported foods present a unique and special challenge to us. Over the last decade, there has been an enormous surge in the volume of food that is imported into the United States. You can now go to the grocery store, any month of the year, and have a variety of products to choose from. For example, you have fruits and vegetables year-round that you never had before. Consumers want this choice. And it's a good choice. Many of these foods are the types we encourage people to eat as part of a healthy diet. However, when more and more food is coming from all around the world, not only does the sheer volume of the food present a challenge, but it also introduces more potential sources of contamination. As the volume of imports increases, the percentage of imported foods we are able to inspect decreases. Currently, the FDA is actually only able to sample and test less than 1 percent of imported products. As I have already mentioned, that means we have to target our efforts on those products that present the highest risk to consumers. The FDA has developed a computerized system over the last several years so that we are now able to quickly review import entries and identify products and/or countries where we've had trouble in the past. As I mentioned before, we've analyzed 1,000 samples of imported fruits and vegetables to see where the problems are, and so we're targeting our resources where the greatest known risk is.

Second, we recognize that we can't expect to catch everything at the border, so we are increasing our overseas presence. We are now conducting more on-site foreign inspections, again, focusing on those products that are at highest risk for contamination. We also are increasing our foreign food safety outreach and training programs. Our food safety experts have traveled literally around the world to teach growers and processors what is needed to meet our country's high food safety standards. So far we've been to Central America, South America, the southern Pacific, and most recently to South Africa. We will also be going to the Far East.

There has been enormous interest in these international outreach activities. The good news is that companies that want to export to the United States know we have high standards and they want to meet those standards, and we're doing our best to get the information to them on how to do that.

In summary, yes, there are a lot more imports. And yes, the growing volume of imports is a concern to us. That is why we are shoring up border surveillance and increasing our overseas presence.

Q: An estimated 6 million to 7 million Americans have food allergies. And about 150 people die each year in the United States from severe allergic reactions to food. What is the FDA doing to increase the awareness of food allergens among consumers and food processors?

A: This is a very important issue. I think we have to start by clearly stating the problem. There are a significant number of Americans who have food allergies. About 90 percent of these food allergies are attributed to eight types of food: milk, eggs, fish, wheat, tree nuts, peanuts, soybeans and crustaceans (such as shrimp and crab).

A couple of years ago, we started to see an increase in product recalls due to the presence of food allergens in the product that were not included on the label. The rule is: If it's in there, it's supposed to be on the label so that allergic consumers can avoid them. We worked with the states of Minnesota and Wisconsin to survey food manufacturers. What that survey found really caught our attention. Twenty-five percent of the samples tested positive for peanut allergens, even though peanuts were not supposed to be there and were not declared on the product label. And 10 percent of the samples tested positive for eggs, although eggs were not declared in the label. That is a big problem.

A consumer with a food allergy is dependent on the food label. So those labels have to be reliable. As a result, we've taken a lot of steps to ensure that they are. And, just as important, the food industry has done a number of things, too, and they are to be commended for that. I think that everyone who looks at this problem says: This is something we need to fix. And the good news is that we can.

We have issued a document called a Compliance Policy Guide. It articulates very simple rules on food allergens for industry. If you have an ingredient that may cause a food allergy in your product, you have to label it. And, if you don't label it, it should not be in there. By issuing this policy statement, we're telling the industry very clearly that we're going to be out there inspecting establishments to make sure that these rules are followed. We've also issued clear instructions to our field inspectors on what to look for from an allergen standpoint at food processing plants. The industry has followed suit and has developed their own code of practices for preventing cross-contamination with food allergens.

In conjunction with patient advocacy groups, the food industry has developed guidelines to simplify allergen labeling in the food ingredient statement. The idea behind this effort is to speak to consumers in "plain English." If it is a milk-derived ingredient, for example, the ingredient statement will very clearly say "milk" ingredient rather than something like "casein" or "whey." This tells a consumer allergic to milk not to eat it. Clearer labeling is a significant step up for consumers.

As soon as this issue emerged, everyone--whether on the industry side, the consumer side or the government side--agreed that food allergens are a real problem and that the problem needs to be addressed today. There really has been a lot of positive response and that's good for consumers with food allergies.

Q: What else has the FDA done to improve the labeling of food?

A: One of the FDA's greatest developments over the past decade was the development of the new food nutrition label. The label, which now appears on virtually all food products, gives consumers clear and reliable information on everything from calories, fat and sodium to protein and vitamins. That same principle of clear and reliable information to consumers is something we've applied to food labeling across the board. If there are claims of a health benefit in the labeling, we make sure that they are supported by good scientific studies and that they state clearly what the benefit is, without over-promising. It applies to clear information on food allergens, and, increasingly, it applies to safety information we want consumers to be aware of.

For example, a couple of years ago we required a warning on unpasteurized juice products after there was a series of illnesses and one death. We wanted to be sure that consumers were aware that our most vulnerable populations--children, the elderly, and persons with weakened immune systems--could be at risk of serious illness from consumption of juice that is not pasteurized.

Q: The FDA, as part of a cooperative effort with the Federal Trade Commission, Health Canada, and state attorneys general recently took action against several marketers who fraudulently sold dietary supplements and other "health" products on the Internet. What should consumers do to ensure that the health products they buy online are legal, safe and effective?

A: The Internet certainly has provided greater access to everything from information to products. That includes food products and dietary supplements regulated by the FDA. It is much more difficult for the agency to regulate products sold over the Internet. It's harder to find where the marketers are. And if you are a marketer, it's easier to close down one Web site and start up another than to close down one set of offices and reopen another. When necessary, we are taking action against products sold on the Internet that do not meet applicable requirements. We are also partnering with other federal agencies like the Federal Trade Commission and state agencies. But consumers need to do their part, too. The basic advice is: Do your homework. Talk to your health-care professional to make sure that the products you use are right for you. That's true whether you're buying a product on the Internet, at the grocery store, or at your local health food store.

Dietary supplements have a lot of positive uses but they also carry some potential risks, and every product isn't appropriate for everyone. Consumers need to take responsibility for doing the proper research and for consulting with health-care professionals to ensure that the products they take are right for them. It's also important for those who use supplements and take prescription drugs to tell their health-care provider what they're taking because we're starting to learn more about cross-reactions among different products. If you don't tell your health professionals all of the drugs and supplements that you're taking, they won't be able to advise you correctly.

Q: What's the biggest challenge that you and the staff at the Center for Food Safety and Applied Nutrition face each day?

A: The biggest challenge we face in an agency like the FDA is to be sure that we stay focused on those problems or issues that most directly benefit American consumers. Each year, our center sends out a call to consumer groups, industry groups, and to health-care groups, asking for input on what we should focus on during the next year. The central question is: Where do we do the most good for consumers? That's how we stay focused. There are so many issues, and so many groups that want us to pay attention to their needs. We need to keep the consumer who lives next door first and foremost in our minds. That's why we exist.

Q: What's the take-home message?

A: First, that the world of food safety has fundamentally changed in many ways. The consumer has to change with it and the government has to change with it, too. Take computers for example. It's obvious to everyone that the world of computers has changed--in barely a generation we've gone from electric typewriters to laptop computers and ready Internet access. Everybody can see that. The change in the food supply is much more subtle. It's harder to see. But the changes are just as dramatic. We are now eating a greater variety of foods, particularly seafood and fresh fruits and vegetables that are eaten raw. On the one hand, these products are nutritious. On the other hand, these foods can introduce many more sources of potential contamination, since they are not cooked.

There also are many more kinds of harmful bacteria that can potentially contaminate our food. A physician from the American Medical Association said recently, "It's not your grandma's kitchen any more." That's true. Today, Americans get their food from all around the world, every month of the year. We also eat more food prepared outside the home where more and more food workers become involved in preparing our food, cooking our food, and serving our food. And when food is contaminated, there are many more people who are more susceptible to foodborne illness--pregnant women, the very young, the elderly, and those with impaired immune systems.

So we now have a food supply that has within it a whole different dynamic than the one we grew up with. People need to know that the world of food safety has changed. That means increased vigilance all around. Does that mean that people need to be scared? No. What it does mean is that people need to take proper precautions just like they do when they get into their cars and fasten their seatbelts. Our main consumer messages are: Keep your hands and cooking surfaces clean; cook food to proper temperatures; refrigerate food promptly; and separate foods to avoid cross-contamination--in other words, don't put raw chicken on the cutting board just before you cut lettuce. "Healthy vigilance" for everyone involved should be the take-home message.