Remarks as Delivered by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
October 4, 2011
It’s a pleasure for me to be able to join you today - and to work with all of you to fulfill the promise of creating a seamless food safety system, from farm to fork.
Will Rogers liked to say that most political promises are about as solid as applesauce. Which, by the way, the FDA does regulate… But some promises are just too important not to keep…like the promise that our food supply will be safe for every American.
It's a promise that speaks to government's most important function: to safeguard the well being of all of its citizens.
It’s a promise that the FDA has been striving to keep for more than a century.
And most of all - it’s very much a shared promise. It’s something that everyone in this room - government officials, public health experts, industry and consumer groups - believes in…has worked for…and is committed to renewing and pursuing.
But if we want to keep that promise in the 21st century, we need to always remember that today’s food supply is certainly different than when the FDA was founded…or even when this conference was first held.
We all know that our food now comes from an increasingly complex supply “ecosystem” that includes everyone from the largest agricultural producers to small organic and sustainable farmers; from large-scale processed food manufacturers to small family bakeries or producers. Moreover, our food today travels greater distances. And we’re part of an ever more interconnected world with porous borders--borders that can as easily let in an illness as an exotic food.
All of these changes bring benefits in terms of an abundant, diverse, accessible food supply. You can have mango and apricots all year round, but these changes - and so many others - also make our historic shared promise harder to keep…
…We’re all aware of the statistics on the burden of foodborne illness in the United States. About 48 million Americans -1 in 6 - gets sick each year…128,000 are hospitalized…and 3,000 die.
But abstract numbers…or dry statistics, don’t capture the real face of foodborne illness. That face belongs to the victims, someone like Rylee Gustafson -a courageous fourteen year old I’ve had the privilege of meeting. As you may remember from the headlines, in 2006, when she was nine years old, Rylee ate from a bag of contaminated spinach. She got sick. Her kidneys failed…and there was swelling around her heart and brain. Although Rylee eventually pulled through, she will probably need a future kidney transplant.
It’s for people like Rylee - and for every American - that we must renew our shared promise to keep our food supply safe. But we also must do it because confidence in our food supply is not only good for consumers…it’s good for the well being of our vital food industry…and for the overall health of the American economy.
That’s why we at the FDA - in partnership with all of you - have been working so hard…and why we must continue to work so hard. Unfortunately, when it comes to keeping our promise - to paraphrase the poet - we know that we still have miles to go.
This morning, I’d like to talk with you about what we’re doing to strengthen our food safety program. Then, I want to discuss with you the challenges to the promise we still face. And finally, I want to outline the partnership for progress we must all be a part of. …Because if we are to continue to keep the promise of food safety, the FDA - or even the federal government - can never do it alone.
As we meet here this morning, nothing better demonstrates why all of this matters than our current efforts to battle the tragic outbreak of Listeria in cantaloupes that began last month.
We’ve been collaborating closely with CDC, along with our local and state partners in Colorado. Once the bacteria was first linked with whole cantaloupes in early September, we worked to conduct a product trace-back, and very quickly identified the matching outbreak strains in samples collected at Jensen Farms in Colorado. Then, in concert with the company, a voluntary recall was quickly instituted.
We continue to partner with the CDC, state authorities, Jensen Farms and its distributor, and the retailers that received the cantaloupes, to ensure that the product is no longer on the market.
Unfortunately, the contaminated cantaloupe has already been linked to at least 84 cases of illness…and 15 deaths in 19 states. In fact, it is the deadliest outbreak of foodborne illness in the U.S. in over a decade. More cases are also possible through October, because patients can develop this disease up to two months after eating contaminated food.
It's the very first time we've seen Listeria contamination in whole cantaloupes. And we’re continuing to work on the root cause analysis to determine how this happened…and to find ways to prevent this from happening in the future. We also intend to take the lessons learned from that outbreak and share them with our partners in industry to reduce the likelihood of future incidents.
And just last week, as part of an FDA assignment to determine the prevalence of Listeria in leafy greens, we detected Listeria in bagged, chopped Romaine from a ranch in Watsonville, California. This resulted in the prompt removal of contaminated products from the market, and may have prevented serious illnesses. FDA and the State of California have initiated a farm investigation at the implicated ranch, and are conducting environmental sampling at the processing facility, in an attempt to identify what contributed to the positive sample result.
Getting to the crux of any outbreak, so that we can learn and prevent future occurrences is, in fact, the mission of our just announced “FDA Coordinated Outbreak Response and Evaluation Network,” or CORE. The Network was announced in September to manage not just outbreak response, but surveillance, and post-response activities.
A new senior position, Chief Medical Officer/Outbreak Director, or CMO, will now have overall responsibility for leadership and management of FDA's activities related to incidents of illness linked to human and animal food. The CMO will also serve as spokesperson during outbreaks. We’re so pleased to have Dr. Kathleen Gensheimer as our new CMO. She’s with us today, and I’d like to ask her to stand. Dr. Gensheimer served for many years as the state epidemiologist for Maine - where I first had the opportunity to meet her-- and we’re fortunate to now have her with us at the FDA.
The ultimate goal of CORE is to build upon the very best of what we currently do across the FDA - and in partnership with the CDC and others - in incident response. Not just to streamline, but to the strengthen FDA’s efforts to keep our historic promise.
But no matter how well we respond to outbreaks - that will never be enough. The best way to protect consumers…support the foundation of public health…reduce foodborne illness…and, ultimately, keep our historic promise, is through prevention.
Prevention is also the cornerstone of the landmark FDA Food Safety Modernization Act. And it’s the message that all of you in this room - consumer groups, industry groups, food safety researchers and experts…as well as Rylee Gustafson…carried to Congress in support of FSMA. FSMA passed precisely because the diversity of interests - the interests represented in this room - tackled the challenge together…and shared a common goal.
In these difficult and divisive times, the passage of FMSA is a compelling illustration of the power and importance of partnerships. And we are absolutely committed to implementing the FSMA, quickly, transparently, and seamlessly…and to stay engaged with you as we put the law’s reforms into place.
We’ve participated in more than 300 presentations and listening sessions around the country and abroad, focusing on what we’re doing…and on what we’re thinking. Perhaps most important, we’ve also been asking what we can learn from you.
In the first four months of the new law, we’ve held three public meetings to hear your ideas on issues such as preventive safety controls for food and feed processing plants, and importer accountability. And we’ve opened dockets to solicit public comment…to hear voices from around the country, from individuals as well as organizations.
Of course, we’re doing more than talking - and listening. We’ve recently announced the launch of the pilot project to improve how we trace products during an outbreak. And we’ve improved our web-based recall site so consumers can find out the latest information easily. Most significantly, in the near future we expect to release our proposed rules on preventive control standards for food and feed processing facilities - the very heart, many would say, of FSMA.
Those standards will represent a watershed in food safety in the United States. They will make clear the primary responsibility of food producers, processors, and distributors for the safety of the food they make and transport. It’s a responsibility which, I know, industry and consumers take as seriously as we do, because it’s in everyone’s best interest.
Additionally, FSMA will also go a long way toward improving consumer confidence in foods from beyond our borders. Thanks to this new regulation, importers will have to verify that their suppliers have the same preventive controls in place as those required of U.S. industry.
As we’re all aware, FSMA is the most sweeping reform of our food laws in more than 70 years. It promises a safer food supply - whether domestic or imported - than we enjoy today. It promises to protect and promote the public welfare. …And it promises to bolster industry by building consumer trust.
Unfortunately, writing the rules sometimes feels like the easy part - and that brings me to my second area of discussion, the challenges we at the FDA face in keeping our shared promise.
If we want to ensure that our food is safer, we need to be able to invest in compliance. We need to help educate and train industry - especially small businesses - through guidance documents that address the real-world issues companies face in trying to abide by the rules. We need to educate and train our own work force, because we’re asking them to inspect facilities with an eye on prevention and problem-solving - not just effectively writing “speeding tickets” for infractions.
We need to stay up to date on the science, and on innovative industry technologies and practice. We need to do all of this, and frankly we need to do more of all of this: more training and education, more inspections, and more science and research.
We understand that these are times of fiscal constraints, and we’re committed to doing our job by allocating our resources based on risks and priorities. But we certainly can’t do everything we need to do - not without a significant infusion of financial resources.
We also need to ensure that the public understands just how big our job - including the job of industry - is, if we’re to live up to the promise of food safety reform envisioned by FSMA.
Also critical to the success of the food safety reforms called for in FSMA is the FDA’s continuing ability to bring the best and newest science to bear, often in partnership with the private sector. We’re doing world class science at FDA - and let me give you an example.
FDA scientists are successfully using a new genome sequencing test to help trace the source of infection. The value of this technology became evident during a 2009-2010 foodborne illness outbreak of Salmonella Montevideo, which was linked to spice rubs on certain salamis, and which sickened nearly 300 people.
Field investigators collected samples of the suspect product to find the source of the contamination. However, conventional laboratory testing methods could not distinguish between the outbreak involving spiced meat, and certain previous Salmonella contamination events.
Next-generation sequencing (NGS) was able to show a common origin of the outbreak strain - a single food facility - and a single source: a spiced meat rub. This technology will have an important role in augmenting future outbreak investigations.
In food safety, we know that many of the risks of tomorrow may not even be on our horizon today. We need a world-class science base to see over that horizon. We need to continue to work on preventive controls, importer accountability, compliance, and inspection. We also need to ensure the greatest transparency when it comes to implementing FSMA - if we want to ensure our historic promise.
FDA will do its job - that’s a promise. But we need industry - large and small, foreign and domestic-to embrace a “food safety first” mindset. It’s a mindset that doesn’t do things because they’re required - but because they’re right…right for people…right for market growth…right for consumer confidence…and right for economic health. Much of industry understands this and is leading the way, but all components of our food industry must embrace a food safety first mindset, so that the promise of a safer food system can become reality.
Of course, if keeping our historic promise is - as I’ve noted - really a promise to safeguard the welfare and the well being of every American, and it speaks to the most fundamental challenge the FDA must face: Promoting public health.
So let me take a few minutes to also talk about some of our ongoing efforts in the area of nutrition and health.
As many of you know, we’re taking a closer look at how we can update and improve the Nutrition Facts panel. This is important because nutrition labeling offers the opportunity for consumers to make informed choices, and incentives for industry to redesign food products.
As we work on this effort, we’ve asked for input on issues ranging from mandatory nutrients, to serving sizes, to the labeling on the prominence of calories - and we expect robust comments when we’re ready to propose modifications to the Nutrition Facts panel.
We’ve already had robust comments earlier this year on our proposals to provide consumers important nutritional information on menus and menu boards at chain restaurants, retail food establishments, and vending machines.
The FDA is also playing a vital role in a public-private sector initiative, announced recently by Secretary Sebelius, to improve the public welfare by promoting cardiovascular health. As part of that initiative, FDA, along with USDA Food Safety and Inspection Service, is seeking comments, data, and evidence relevant to the dietary intake of sodium…as well as current and emerging approaches aimed at promoting sodium reduction.
We know that excess sodium intake contributes to high blood pressure, a major risk factor for heart disease and stroke, and we’ll be moving forward with this important public health initiative.
These are all important steps…but they are all steps to build on. And the success of these initiatives - as well as all of our work - depends not just on us, but on you. That brings me to my third and final area.
We know we have promises to keep, and if we want to fulfill them, then each of you must continue to partner with us. That does not mean we give up our regulatory responsibilities.
Partnership means respecting the important role each of us - every stakeholder - has in ensuring a safe food supply…and a food supply that nourishes the welfare and well being of our children and ourselves.
Partnership means always recognizing that all of us - industry, consumers, and government - want a safe and healthy food supply.
And partnership means navigating a common course in our common cause.
Of course, this is the way that people in this room have already come together… joined together…and gone forward together. And it is exactly the kind of partnership that the American people want to see at this time. …This is a partnership that’s not driven by rhetoric, but by results…
Protecting and promoting health - by ensuring both the safest and the best food supply possible - is what the FDA wants. It’s want industry wants. It’s what consumers want. …And it’s definitely what Rylee Gustafson wants.
By always working together in a partnership for progress, we can keep - and renew - that historic shared promise that Americans desire… deserve - and need.
For all that you’ve done…and for all that I know you will continue to do, I am grateful. This Administration is grateful. And - most important - the American people are grateful.