Food Recalls: FDA Takes Preventive Approach

Eli Y. Adashi, MD; Michael R. Taylor, JD


February 10, 2011

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Eli Y. Adashi, MD: Hello. I am Eli Adashi, Professor of Medical Science at Brown University, Providence, Rhode Island, and host of Medscape One-on-One. Joining me today is Mr. Michael Taylor, the first-ever Deputy Commissioner for Foods at the US Food and Drug Administration (FDA). Our topic: food safety. Welcome.

Michael R. Taylor, JD: Thank you. It's great to be here.

Dr. Adashi: As it turns out, this conversation could not have been better timed. On January 4, barely 3 weeks ago, President Obama signed into law the FDA Food Safety Modernization Act, a seminal piece of legislation that was long in the making. We are very pleased to have you here with us today to discuss what this legislation means to the FDA and to food safety, especially because the CDC [US Centers for Disease Control and Prevention] and the Institute of Medicine have reported that food safety continues to constitute a major public health threat. So, it's good to have you here and to discuss some of these elements as they emerge.

Mr. Taylor: It is great timing, and I'm really pleased to be able to talk with you about this.

Dr. Adashi: Just to get us started with the basics, if I may ask: What is the designated role of the FDA in overseeing food safety?

Mr. Taylor: The FDA has jurisdiction given by Congress to oversee the safety of most of the food supply. About 80% of the food supply is under our jurisdiction to regulate for food safety as well as labeling and nutritional quality of food. The US Department of Agriculture regulates meat and poultry, and meat and poultry products, which comprise about 20% of the food supply. So, we oversee a big part of the domestic food supply; plus most of the food imports are under the FDA's jurisdiction. This is a big part of our challenge today because we really have a flood of imports coming from all over the world: 80% of our seafood, half of our fruits, and 20% of vegetables come from overseas. Many basic food ingredients come almost entirely from overseas. So, we're in a globalized food supply, and the FDA is the federal agency that has primary responsibility for ensuring the safety of the food supply.

Dr. Adashi: You mentioned the US Department of Agriculture, also known as the USDA, as having a role in overseeing food safety. Are there other agencies beyond the FDA and the USDA that are, in one way or another, involved?

Mr. Taylor: Depending on how you count them, there are a dozen or more agencies that have some involvement in food safety. The other agency that has an important regulatory responsibility is the US Environmental Protection Agency (EPA), which sets the standards: the allowable levels of pesticide residues in food. This is an important public health issue. We want to be able to use pesticides to grow food efficiently and safely, but we have to be sure that the residues are safe. So, the EPA evaluates the safety of pesticides and sets limits or tolerances on the amount that can be in food. The FDA then enforces these tolerances through its inspection and sampling of products.

Dr. Adashi: With the introduction of the new law, is any of this division of labor, so to speak, going to change in any way, or is it going to remain as is?

Mr. Taylor: The basic regulatory jurisdictions between these major regulatory agencies remains as is, but an important feature of this law is that it calls for much enhanced cooperation between agencies involved in food safety. I didn't mention the US Centers of Disease Control and Prevention, which is a critical sister agency within the US Department of Health & Human Services, of which the FDA is part. Of course, the CDC has the primary responsibility for foodborne illness surveillance, and the data that the CDC generate are very important to our role in understanding what the most significant problems are and informing our efforts to be preventive with respect to foodborne illness.

We've got a very specific charge in this legislation to work more closely with the CDC, for the CDC to respond more directly to the data needs of the regulatory agencies and the industry and consumers, and work much more closely with states and localities. This is something that I think people miss, that most of the government work on food safety is actually done by state and local agencies, which have the primary frontline responsibility of inspecting retail establishments, such as restaurants and grocery stores. The FDA contracts for many of the food inspections that it does. It contracts with state agencies that actually conduct the inspections for us. A whole network of laboratories, public health laboratories, and food laboratories are important parts of the food safety system. Actually, one of the most important features of this legislation is that Congress has recognized that all of these agencies need to work together more closely, and we've been given some very specific direction to do that.

Dr. Adashi: It seems fair to say that, in general, the public and I think the providers who are our viewers probably are not as familiar as they would like to be in all that is entailed in maintaining food safety.

Mr. Taylor: This enormously complex food system that we have includes literally millions of food producers, farmers, processors, people who transport food, people who market it at retail, and people who prepare it for consumption in restaurants, and enormously complicated issues arise in which hazards can enter the food supply -- bacterial contamination or chemical contamination -- at almost any point along the way. So the challenge is to figure out how, looking at that system as a whole, how we can take the steps at each point along the way to prevent contamination that can make people sick. That's what it comes down to.

It's a complicated system, so it's a complicated set of problems, for sure.

Dr. Adashi: I think we all agree that food safety is nonnegotiable. We just realize how complex the system is and how difficult it likely is to keep it all together.

As you know better than most, we have witnessed very high-profile recalls of food products of a variety of sorts. When monitoring the frequency of recalls, is there any evidence that recalls are on the rise?

Mr. Taylor: One of our biggest challenges is understanding trends in foodborne illness and getting accurate counts of the incidence of illness as well as numbers of outbreaks of illness. This, of course, is primarily the role of state and local health departments reporting to the CDC. But one of the weaknesses, frankly, in the system is that most of the data that are collected are passively reported, meaning that we rely on physicians and local labs to report when they have an illness. When they take a stool sample, when they get the lab result, you report that into the public health system so we can have more accurate information. Nevertheless, the CDC has some really good programs of surveillance and are increasingly getting more accurate estimates of foodborne illness. What we find is that in some cases, with respect to some pathogens, such as Escherichia coli (certain strains of E coli), we're doing better. We have fewer cases. In other areas, like Salmonella, which is one of the most significant causes of foodborne illness, we're having a hard time reducing the numbers.

We know that we can do better. We know that we can prevent foodborne illness more effectively than we're doing, and of course that's what this new legislation that you mentioned earlier is all about; it's about being able to systematically put in place the measures to prevent the causes of foodborne illness throughout the system. We hope over time to be able to measure and work closely with the CDC to be able to measure trends in foodborne illness.

One thing I would add is that the public hears more about recalls, and we are sometimes finding more outbreaks than we did in the past because we have much better tools for detecting outbreaks. Outbreaks of illness are much more easily and readily detected these days because we have tools of microbial fingerprinting, if you will, that permit us to connect cases of illness that might be occurring in different parts of the country but are linked to a common cause. So, outbreaks that would have gone undetected before, we are detecting now. That can be disturbing to people, but it's a good thing from a public health standpoint, because we can then work to contain that outbreak and can learn from that outbreak to prevent future problems.

Dr. Adashi: One cannot help but sense that the term "connectivity" undergirds much of what is being done or needs to be done between the FDA, the USDA, the CDC, and of course the food producers. How would you characterize where we stand in terms of our ability to connect with each other so that we can all find out about these incidents as soon as possible, and if at all possible, intervene before it gets worse?

Mr. Taylor: Connectivity is a great way to think about where we need to go. I think we've made a lot of progress on that, whether it's connecting with other federal regulatory agencies or connecting with our state and local counterparts, and certainly with the industry, but there are vast amounts of data that are generated everyday throughout this food system concerning levels of microbial contamination of certain foods, practices that relate to reducing the risk for contamination, and inspections being conducted by state and local agencies. We aspire to be able to pull all of those data together to give us a much better understanding of what the problems are and therefore be able to put in place the right preventive measures. Therefore, connectivity is a great theme for where we need to go, and that's in the legislation. Congress has understood that, amazingly. Congress sees that we need to build a system. It's a wonderful piece of legislation for those of us who have been in this field because Congress has come to grips with some of the basic public health infrastructure issues that need to be addressed to have a more effective food safety system and be more effective in preventing foodborne illness, which is, of course, one reason we're really excited about implementing this law.

Dr. Adashi: Our viewers are healthcare providers. This may be an opportunity for you to address what, if anything, those providers can do in support of food safety before, during, or after an incident. How can they be of assistance to you and indirectly, therefore, to all of us?

Mr. Taylor: We see physicians and the healthcare system being an important part of the food safety system, certainly at the treatment stage. We've had challenges in the past when new pathogens emerged that previously weren't understood to be causes of foodborne illness. The E coli 0157:H7 in particular, a very dangerous strain of E coli, emerged just 25 years ago as a human pathogen, and it's now fairly pervasive. Originally, physicians weren't clear as to what was happening. In fact, it turns out that these bacteria can cause very severe illness and organ failure, and it was sometimes taking too long for physicians to understand what was happening. That's changed. There's been a lot of education and a lot of improvement at the treatment end.

What we're focused on at the FDA, of course, is the prevention side. We see physicians having a critical role there as well, educating their patients and certainly new parents of young kids. Babies and young infants as well as young children are the most vulnerable to some of the pathogens, the bacteria that are causing foodborne illness. Just as we need to educate parents about car seats, we should educate them about safe food practices and how to look for symptoms of severe foodborne illness so that people can get treatment quickly. We also need physicians to report the illnesses that they detect in their practices. So, physicians are very much part of the system as professionals and, of course, as people with families who are affected. One out of 6 Americans, the CDC estimates, experience some form of foodborne illness every year, so we're all in it together when it comes to foodborne illness.

Dr. Adashi: In essence, 50 million Americans or thereabout every year would at least come in contact with a disease; hundreds of thousands of those would be hospitalized; and a smaller number will end up as fatalities.

Mr. Taylor: Yes. The CDC most recently estimated -- they just came out with new estimates in December -- 3000 deaths annually from foodborne illness. These are, again, almost entirely preventable, so that's what we're focused on: really trying to prevent that.

Dr. Adashi: We don't want to miss this opportunity to discuss the new law and perhaps cover the key ingredients thereof, the main points so that our viewers can appreciate all of the new powers and new authorities, and perhaps new strategies that are embedded in this bill.

Mr. Taylor: We call this law historic, not lightly at all, and not just because it's the first real updating of our food safety laws in over 70 years. It is. In fact, many of the basic tools and principles that we were operating under until this law was passed go back over a century to the first federal food and drug law back in 1906. Those laws were based on reacting to problems, giving the FDA tools to deal with contaminated food after it had been discovered in commerce, often after people had gotten sick. The central thrust of this legislation is to say that the food safety system must focus on prevention.

Dr. Adashi: Prevention rather than reaction.

Mr. Taylor: Prevention rather than reaction, and giving the FDA the charge to set the standards for modern food production and processing and handling techniques that we know can prevent problems. We know because these are techniques that the industry itself has developed over the years. Many in industry already implement them, and everybody needs to implement the right modern preventive controls. We're given the authority and the mandate to establish those standards for every food facility. In addition -- and this is critically important -- those standards make food safer only if we get high rates of compliance with those standards. We have, for the first time ever, an inspection mandate. In the past, we were "authorized" to go into facilities, but Congress is now telling the FDA, "You must go in at a certain frequency." Of importance, we have new tools for enforcing standards, for holding companies accountable for meeting the prevention standards. That's the core concept: the shift from reaction to prevention, new standards setting authority and directions for the FDA, and new tools for holding companies accountable for preventing food safety problems.

Dr. Adashi: Have you been granted additional authorities in terms of mandating recalls when the judgment is made that in so doing you might accelerate the resolution of the issue?

Mr. Taylor: One of the provisions of the law is: for the first time, the authority to mandate a recall rather than relying on voluntary recalls by companies. Most of the time when we identify a problem with products, companies recall the product readily. Sometimes there's negotiation and some delay. But in those cases where we think quick action is needed, we'll now have the authority to order the company to immediately recall a product, which is an important tool for us. It's a failure of the system to have to use it, because we should be preventing and companies should be taking action voluntarily, but it's a tool that we will use as needed to protect people.

The other big thrust of the legislation that I should emphasize -- you mentioned imports earlier -- is very important new tools for building that principle of prevention into the oversight of imported food. Again, historically, until now we've only been able to look at product when it comes to the port of entry, when it comes to the border, and with a very limited inspection force where we can look physically at less than 1% of the shipments; our job has been to catch problems after the fact. Under the new law, the importer is going to be responsible for demonstrating to us, giving us assurances that the food produced overseas has been produced in accordance with the new prevention standards that we'll be adopting for domestic producers. This is a huge paradigm shift, and it gives us much better ability to ensure the safety of foods coming from overseas.

Congress is also directing us to explore possibilities of relying on so-called "accredited third-party auditors"; folks who have met our standards for training and objectivity could go and conduct audits of foreign facilities and provide the results to us. It's a way to give us some efficient oversight overseas. We'll be working more with foreign governments, but imports are a big area of concern. We've needed these new authorities for a long time, and I think we've got a really strong new tool kit to ensure the safety of imports. We'll be doing more foreign inspections, but we really need to use this whole tool kit, relying mostly on the responsibility of the importer to be sure that the food they're bringing in is safe.

Dr. Adashi: By all accounts, there is a deep appreciation and appropriate action taken to address both domestic and international issues, because it is a globalized universe, and you cannot ignore those realities.

You're looking at a significant body of work to implement the multitude of sections that come with this law. I imagine that there is a timeline built into the process. How do you think about it? How do you plan for it? When should we expect the first regulatory declarations to come out?

Mr. Taylor: You're right. It's a massive implementation job. We have over 50 regulations, new guidance documents for the industry, reports to Congress, and 50 major deliverables. It's really building a whole new system. There are timeframes attached to every one of those, and we take those seriously. We also know that we're going to have to prioritize our work. We've spent the last 3 or 4 weeks since the bill was passed by Congress looking at how to prioritize our work and how to make the best use of our resources to get the most public health benefit as soon as possible.

Under the law, for example, some of the first tools coming online will be the new enforcement tools, which we can use even under current standards. If a company is producing product in a way that puts people at risk, we'll be able to suspend the registration of the company and basically stop them from shipping product until they satisfy us that they've solved the problem. We'll be using those new tools quickly. Mandatory recall is available immediately. One of the first things that consumers will see is that we're actually directed by Congress -- this is the level of detail in the bill -- to create a new search engine for our Website so that consumers can get information more quickly about recalls. That will be online within 90 days. Incredibly, the first report to Congress is due in February. This will not be of huge interest to the public, but we'll submit a first report to Congress in February.

The larger pieces of implementation involve the new standards for safe produce-growing practices, for so-called preventive controls in food facilities, those standards that companies must meet to produce safe food. We have to establish standards for intentional adulteration, to prevent intentional adulteration of food. We'll be issuing proposed regulations over the rest of this year. By the end of this year we will be issuing some major proposed regulations, getting public comment, and then next year issuing final regulations.

This legislation will roll out over a period of time. We're building a new system. I think people have to have some patience, but we will immediately have some new tools to solve problems when we find them and to hopefully be more preventive than we have been in the past.

Dr. Adashi: It is estimated that the implementation process would cost on the order of $1.4 billion over 5 years. How do you think about it in the context of today's political environment, concerns about budget deficits and the like? Is that something that the FDA is preparing for, thinking about, and planning contingently for?

Mr. Taylor: We think about it every day. Resources will be a challenge. There's an enormous amount that we can and will do with the resources that we have: establishing these basic standards and using these enforcement tools. There's a lot that we can and will do to improve the system. However, the vision of the law is to build a new system, to build the infrastructure to make our collaboration with the states more effective and efficient, and to build the infrastructure to oversee imports. We will need additional resources. It's incumbent on us to make the best use of the resources that we have, and we think that some of the new tools that Congress has given us will enable us to be more efficient in the way in which we do inspections, to get more public health "bang for the buck," as we say. We're very focused on making the best use of our resources, but we look forward to working with the administration, with Congress, and with the supporters of this legislation out in the private sector to address the resource problem.

One of the encouraging things about food safety and this legislative reform process is that it has brought together a coalition of industry groups, consumer groups, and public health and food safety experts who agree on the direction of the legislation and agree on the need to make this shift to prevention. We look forward to working with them to be sure that we get the resources to carry it out.

Dr. Adashi: One thing to look forward to would be the establishment of such partnerships in an effort to move things forward perhaps in the face of some congressional austerity.

Mr. Taylor: You said "connectivity" earlier; you said "partnerships" now. Absolutely, they are central themes of how we got here, how we got this legislation, and what we'll need to do working in partnership to implement it. We intend to work very closely with all of those stakeholders and the public at large, which has a huge stake in the success of this. We are going to work in a very transparent, participatory way to bring people into the process; to help us shape this; and to support the implementation over time. That's our strategy.

Dr. Adashi: Thank you.

Mr. Taylor: Thank you.

Dr. Adashi: On that note, sincere thanks to Deputy Commissioner Taylor and to you, our viewers, for joining Medscape One-on-One. Until next time, I am Eli Adashi.


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