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Mark B. McClellan, M.D., Ph.D. - NFPA Food Safety Summit

This text contains Dr. McClellan's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

National Food Processors Association's Food Safety Summit
Remarks by

Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs
March 20, 2003

Good morning. I am pleased and honored to meet again with some of the people who have made our country's food production the most innovative and productive in the world. You've contributed to new ways to process foods, leading to levels of safety, diversity, and productivity of food products that lead the world. Thanks to your efforts, Americans not only have more and more diverse food choices than ever; we are also producing vast quantities of food that are sold and donated all over the globe, improving the lives of consumers around the world.

I want to thank you for your creativity, your willingness to adapt and change when presented with new opportunities and new public health concerns, and for your ongoing work to help improve the health of Americans, and of people around the world. I'm looking forward to continuing to work with you to fulfill our shared goal of protecting and promoting public health.

Today, we face new challenges to the health of our nation - and new opportunities to meet them. I want to focus my remarks today on two of the most critical challenges: threats to the security of our food supply because of terrrorism, and threats to the health of our nation because of obesity and associated preventable chronic illnesses. Just as we've worked together to adapt in the past, I am confident we will work together effectively to meet these critical new challenges to the health of our nation.

I am sure that your thoughts and prayers, like mine, are with our military personnel who are today in harm's way. They are protecting us here at home, and we are all doing all we can to support them. At FDA, that has meant an accelerated, major new focus on helping to develop and make available better countermeasures for biological, chemical, and radiological attacks.

I'm pleased to tell you that, in the last two months alone, we've taken big steps to make available safe and effective treatments for certain nerve gases and radiologic agents, and enhanced our stockpiles of vaccines and treatments for smallpox and other possible agents of biowarfare. And I'm very pleased by the unanimous passage in the Senate Health, Education, Labor and Pensions Committee yesterday of legislation to implement the President's proposal for Project Bioshield, which will help us deliver on a much higher level of security for our country through enhanced development and use of countermeasures for terrorism. We need this legislation right away, and we appreciate the leadership of Senators Gregg, Kennedy, and many others in working together to provide us with these critical tools.

We need this legislation because war today is different. We all know that, because attacks are possible on civilians here in the United States as well as on our troops abroad, we on the home front have important opportunities and responsibilities to make our country more secure. That includes new challenges in protecting our food supply.

At our agency, we've been making fundamental changes in how we implement our public health mission. We no longer talk about "food safety" - focusing on protecting the food supply from what can go wrong. We must worry about food security - protecting our food supply from deliberate attack. You all know about the potential for agents of bioterrorism such as anthrax and botulinum toxin to be used to contaminate our food supply. You also know about the potential for contamination by chemical agents, as illustrated by past episodes of cyanide poisoning in imported grapes and by terrorist cells in Europe that were caught trying to make the potent poison ricin. Especially at a time of heightened national alert, the security of our food from deliberate attack by terrorists is a real concern. And unfortunately, I believe this threat will be with us for a long time to come. We are ina new era. The need for a new level of attention to food security is here to stay.

The FDA takes this new level of threat to our nation's food supply very seriously. Secretary Thompson has said that the most important bioterrorism threat facing us is through our food. And so, at FDA we are doing all we can to implement new programs to make our food supply more secure. And obviously, to succeed in meeting this new challenge without creating disruptions and problems in food availability, as well as avoiding unnecessary additional costs, we are going to have to continue to work very closely and effectively with you. This is the main topic that I want to address today.

Let me briefly recap what the FDA has done to safeguard food after September 11, 2001.

We conducted a threat assessment to examine different categories of food for the relative risks of intentional contamination during various stages of food production and distribution. The results are classified, but we know that the requirement of working together to address the challenges to food security means that we need to share certain important but sensitive information with industry and with our state partners. We're currently working hard to find more effective and timely ways to do this.

We have participated with other agencies, most notably the Department of Agriculture, the White House Homeland Security Council, and now the new Department of Homeland Security, in numerous coordinated planning programs as well as internal and external counterterrorism exercises to evaluate the government's emergency response capabilities in various simulated food borne outbreak scenarios.

And we've discussed food security and rapid response and recovery procedures with more than 35 industry groups and trade associations, including your Alliance for Food Security, which has done a tremendous job in this area. I want to thank them for that effort.

We've also drawn on last year's special appropriation of $151 million to hire more than 800 new employees, 655 of whom are earmarked for food safety activities in the field. And I'm pleased to report that, as a result of an aggressive hiring and training program at the agency, these new employees are on the job now to help make the food supply more secure.

Thirty-three of these new hires are import criminal investigators, 300 others are greatly increasing our presence in the United States ports of entry, and 100 will conduct laboratory analyses on imported products. We're posting our personnel at 90 ports of entry, 50 more than 2 years ago, in order to provide on-site coverage for the bulk of food imports into the country, and in order to perform more of our basic operations locally, particularly import field examinations and sample analyses, which are critical in detecting problems in the products we regulate. The remaining biodefense employees will help protect the security of domestic food.

To speed up the training of the new hires and of the estimated 50,000 state, local and tribal officials who are expected to cooperate in the nation's enhanced security programs, our agency has developed new and retooled existing training procedures. Thanks to this intensive training, newly hired lab analysts and investigators start working only three months after they come on staff, and we've reached a new level of cooperation with our state and other partners.

We've implemented new steps to help us identify potentially contaminated products. We emphasize examinations of inconsistencies between shipping documents and the physical product, evidence of tampering, substitution, counterfeiting, and suspicious or damaged merchandise. We're collecting more samples than ever, and developing new screening methods and surveillance tools.

All of this work is enhancing our food security, but we need to do more. Yesterday, we announced a set of new measures as part of Operation LibertyShield. Operation LibertyShield is a comprehensive national plan designed to increase protections for America's citizens and infrastructure while maintaining the free flow of goods and people across our border with minimal disruption to our economy and way of life. Operation LibertyShield is a multi-department, multi-agency, national team effort, and the Department of Health and Human Services has many critical roles in this effort.

At FDA, our LibertyShield initiatives focus on enhancing the security of the 80% of the food supply for which we are responsible for safety and security. And this is another example of how we need your help and cooperation in our efforts.

We published four guidance documents on how to safeguard regulated products against terrorism. One of these guidances deals with cosmetics, and three address security problems of food establishments. The food security guidances cover all major sectors of food production, distribution, and use. Two of these documents finalize the guidances issued in January, 2002. They include a security guidance for food establishments - firms that produce, process, store, repack, distribute, or transport food or food ingredients - and a guidance for food importers - firms that are food importing establishments, storage warehouses, and customs brokers. We appreciate your help in developing these guidances. The new draft guidance covers food stores and food service establishments such as bakeries, bars, cafeterias, convenience stores, fairs, grocery stores, restaurants, and vending machine operations. And we look forward to your suggestions on how we can improve these guidances and make them even more useful to you.

These documents include straightforward, practical steps that virtually all firms involved in food production can take voluntarily to minimize the risk that the products under their control will be subject to malicious, criminal or terrorist actions. For example, the guidances recommend measures to limit access to critical areas and computer systems, investigate missing or increased stock, and if possible institute visitors' check at entry. We know that many of you have already implemented many of these steps, and in some cases further measures; in fact, your "best practices" were the source for much of the practical information included in the guidances.

And we know that the diversity of circumstances and conditions across food firms means that security steps cannot be "one size fits all." So we encourage you to look at the relevant guidance for your firm as soon as you can - they are all available on our website, www.fda.gov, and we are starting an education and outreach program as well. We want to help make sure that you are taking all reasonable steps to help make our food supply secure.

Also as part of Operation LibertyShield, we are increasing our food inspections and sampling for important agents of terrorism. We have recently invested over $1 million in emergency funds to purchase test kits that enable us to sample for these agents, and we are starting to use these kits more widely in our inspections and testing of both domestically produced and imported foods.

And we'll be making further efforts to work with the food industry as we carry out investigations and import audits, to make sure these firms are aware of potential terrorist activities, especially as they relate to raw material shipments, inventory quarantine procedures, sourcing of foreign products or ingredients, and vulnerable operations.

Finally, since last summer, we've been busy implementing the Public Health Security and Bioterror Preparedness and Response Act. As you know, this law considerably strengthens our authority to ensure the security of food, with emphasis on import security, and it imposes on the FDA new responsibilities in this area.

I will not spend much time discussing the four key provisions for which we are preparing enabling rules, because you're familiar with them. Proposals for two of them -- for registration of facilities and prior notice of imports -- were published last month, and have a 60-day comment period. The other proposals, for record keeping and administrative detention, are in review and will be published in the next month or so. But I want to emphasize that if we receive specific information about a particular risk to food safety, the bioterrorism act gives us authority to take steps now to address the threat. We can take action to protect the food safety against a specific threat even even before the regulations are in force. Obviously, however, getting these regulations in place this year is our top priority.

Now, we realized from the start that food producers have important and legitimate concerns about the impact of some provisions of this law, that do represent fundamental changes in the way our food regulations operate. And we know that the food producers and processors have an extremely valuable perspective on how the requirements in the law can be implemented to achieve the greatest benefits for food security without imposing unnecessary costs or regulatory burdens on food production, processing, and distribution. We've therefore taken careful steps to explain what are our objectives, and how we expect to reach them.

We've conducted numerous outreach efforts. We have issued Dear Colleague Letters explaining the new regulatory requirements, we have held constitutent briefings with stateholders, we considered over 150 comments received during the early comment period, and we used those in developing our proposed regulations.

In addition, we've held a public meeting via a satellite downlink and a series of outreach meetings with government and industry officials in Canada, Mexico, and other nations. And of course, we are encouraging stakeholders to submit written comments for consideration as we develop the final rules.

We understand from the feedback we have received so far that there are areas where we may be able to improve our proposed regulations - and we're looking forward to additional comments as the process of implementing the law continues. For example, based on the two rules we've proposed so far, we've received requests for different modes of transmission of the required data, for different schedule for the registration of facilities, for alternative ways of handling food product categories, for better ways to update registration information, and better guidance on which firms will have to register.

We've also received advance comments on regulations we have not yet proposed. For example, on making sure that we don't impose any measures that would cause unnecessary costs. And we've received useful comments on how to keep track of the import information we need, and how to allow for its modification and updating.

As you know, we are under considerable pressure to implement these regulations. We will keep all of the comments in mind as we are carrying out this critical program, and I assure you that the final rules will be published by October 12. By December 12 we'll have to register close to half a million food firms, and have two information technology systems up and running: one that's capable of receiving those registrations, and another one that can handle the approximately 20,000 import notices we expect to get every day.

We must also educate the affected firms in the implications of our requirements, and train our staff that will run the operation as efficiently as possible.

This is a huge enterprise, and we will try to conduct it with the help of the latest risk-assessment science and on the basis of sound cost-benefit principles. We have no desire to add to food prices or restrict the diversity of food choices that are a hallmark of American consumption.

Over the coming years, I believe the best solution will be the adoption of a risk-based import surveillance system to replace our current import program, which is fully linked with U.S. Customs entry processes - processes that have been designed to address revenue and trade issues, not public health issues.

We're moving in the direction of a modern, risk-based system for food imports already. This is critically important, because our food imports have almost tripled over the last decade. They come from all parts of the globe. We expect to receive almost 6 million shipments this year.

To address the challenge of food import security, we're shifting toward a "life cycle" approach to imports. For example, for bulk imports, instead of a taking a snapshot at the border by examining and sampling a particular shipment, we're trying to get a broader picture that covers the product's history from raw materials, through production, transportation, storage, to the U.S. manufacturer/producer if there is one, and to the ultimate consumer. By taking this broader approach, we can come up with the most efficient way of protecting our food supply without imposing additional costs on the government or the food industry.

We must improve compliance with U.S. standards before the products reach our border, and track problems efficiently after they enter our market. One part of the job is increasing inspections for good manufacturing practices abroad and including a look at imported bulk ingredients and raw materials during our domestic inspections in order to properly assess the risk from imported products. On the domestic side, if we can work with domestic processors who are already implementing many steps to check the quality and integrity of their products, we will have additional tools to make sure that adulterated imports do not make it into the nation's food.

We are also factoring in the risk information in deciding how to best manage the risk of intentional contamination -- whether by working with foreign countries and/or manufacturers to improve compliance, or by facilitating entry of products that provide assurance that they meet our health and safety standards. We want to enable those products to enter our country easily.

So, we have accomplished much to improve our food security. Yet there is much that remains to be done to ensure that we are fulfilling our mission of food security as efficiently as possible, and without unnecessary regulatory burdens. And we will continue to work closely with you to meet this critical new challenge.

I want to take couple of minutes to talk about another challenge: finding ways to encourage competition to promote healthier diet and lifestyle choices by Americans. As you know, we have an obesity epidemic in this country, with about two-third of Americans overweight, and a third obese and a heightened risk for many health problems. In response to this, our agency announced a new initiative on Better Health Information for Better Health last December.

I expect you are familiar with the basic provisions of our health information initiative of last December.

We're proposing a preapproval mechanism that involves a scientific review, by experts in our agency, to allow health claims by foods and dietary supplements that are supported by the weight of scientific evidence. This so-called "qualified claim" approach has long been used by the Federal Trade Commission, and there is much evidence that it leads to desirable changes in consumer behavior.

We've also appointed a Better Information for Better Health Task Force to develop an appropriate paradigm for qualified health claims for food and identify a research agenda for exploring consumer understanding of those claims.

And third, we've implemented enforcement measures against fraudulent health claims, particularly involving some dietary supplements,

Our task force has had several formal meetings, including one with a stakeholder group -- health professionals -- and is planning similar exploratory meetings with consumers, industry representatives, and academicians over the next few months.

In addition, we're opening a docket for comments on standards and approaches for our approval process for providing qualified health claims for food. All of this information, to which I am sure you will contribute, will be carefully considered by our task force in making its recommendations for the long-term course of the agency in getting better information to consumers. We want consumers to know more about dietary choices that can improve their health. And we want to encourage competition food firms not only on the basis of taste and serving size of their products, but also on the health benefits of their consumption.

The Task Force also has a special subcommittee that's considering options for dealing with fraudulent claims on dietary supplements. As you know, we've issued warning letters in recent months against misleading claims on certain dietary supplements to treat various serious and chronic conditions. They range from undocumented claims for treating viral illnesses to equally undocumented claims such products as ephedra, which do not have any proven health benefits. We'll be doing more in this area as well.

So there is much that we're doing at the agency, and much more remains to be done in the area of food security and in promoting better health for all Americans through the food they eat. We're looking forward to work on these issues, which are among our most important priorities, and we need your help. Your industry is critical to the public health and to the U.S. economy, and we need your cooperation to meet our challenges -- for the sake of our economy, and most importantly, for the sake of the health of our citizens.

Thank you. It's been a pleasure to be here, and I am looking forward to more such encounters in the months to come.