FDA In India: Going Global, Coming Home

By: Altaf Ahmed Lal, Ph.D. 

What is it like to be starting my new position as director of FDA’s office in India

It’s like coming home. 

My new tenure at FDA began in June, but as a former health attaché in the U.S. Embassy, I played an enthusiastic role in helping to establish FDA in my native country. 

I was born in Kashmir, India, and though I left the country in 1980 to explore new professional opportunities in the United States, I have since been drawn back again and again. 

It’s a beautiful, vibrant and interesting country, a unique mix of cultures, languages, and political viewpoints. It’s a country rich in agriculture, information technology and education that is constantly expanding its reach in industry, including the pharmaceutical and biotechnology sectors. It’s second only to Canada as the United States’ largest supplier of pharmaceutical products and in 2011 was the seventh largest exporter of foods to the U.S.

Accepting the responsibility to assume the helm of FDA’s office in India presents a rather daunting challenge. But as my colleagues, and most certainly my wife and three children will tell you, I am not one to shy away from a challenge – quite the opposite. 

In India, it begins with the recognition that FDA, which started as a domestic regulatory agency, has now, by necessity, become a global one. A large part FDA’s role in overseas offices is helping to ensure that products bound for export to the U.S. are safe, of high quality and effective. 

I see our mission in India as three-fold: first, to work closely with FDA’s Indian counterparts, establishing a relationship based on trust and regulations built on solid, scientific evidence; second, to conduct prompt and thorough inspections, when needed, of firms producing products for U.S. export. And third, to help industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential. These three criteria cannot be ranked; each is as important as the next. 

Over the next 12 to 24 months, I look forward to hosting several workshops for open, transparent discussions with industry and regulators on what systems of preventive controls need to be in place throughout the lifecycle of any manufacturing process. What controls do we need to guarantee that at the end of the day, products are safe and effective? Which checks and balances should be standard procedure across the board? 

Part of the challenge is to define those milestones by which we can measure success. I want a manufacturer to ask – and be able to answer – the questions, “Why are we failing inspections?” And “What specific controls do we still need to put into place on a 24/7 basis so that on the next FDA inspection we will pass?” 

I think the answers to those questions can be found in three words: collaboration, coordination and commitment. 

A colleague recently likened my new role at FDA to scaling Mount Everest. But you know, I’m fond of trekking and climbing, and view this next challenge much as I do those activities, as both a challenge and an adventure. I’m eager to be a part of it. 

Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

FDA Brings Patients Into the Process

By: Michelle McMurry-Heath, M.D., Ph.D. 

What do patients really want? 

At the FDA, we ask that question every day and in all kinds of contexts. Earlier this year, the Center for Devices and Radiological Health (CDRH) began to explore new ways to identify and incorporate the patient voice into our decision-making on medical devices. 

We’re calling this effort the Patient Preference Initiative. As part of this effort, we held a public workshop the past two days with patients, caregivers, health care providers, researchers, and industry to discuss ways to incorporate patient preferences as we weigh the risks and benefits of the products we regulate both before and after the product goes to market. 

In trying to incorporate patient preferences into our regulatory decisions, it’s important to know how to accurately and reliably measure their preferences for treating and diagnosing their conditions. So, we’re also trying to advance the tools and methods that could be used to do so. 

For example, there is a risk of injury with many medical devices. How much of a risk is acceptable to a patient in the context of the potential benefits of the device? If patients enter a clinical trial, how much of a chance are they willing to take on an unproven treatment? If a device could greatly improve a patient’s health, but is not portable or cannot be used at home, would a patient find this too limiting? If a device has new-found risks but is the only one of its kind on the market, should it be recalled? 

In appropriate cases, we foresee approving devices for which a fully-informed subset of patients would accept the risks as weighed against the benefits, if patients and their practitioners can be provided with the information they need to make their own well-informed decision and the information can be presented in a manner that can be understood by the practitioners and patients. 

At the workshop, we invited attendees to actively explore such issues as clinical trial design and ways to facilitate getting new, safe and effective, innovative devices out to the patients who may need them. Our panels weighed in on such questions as: 

  • How do we integrate patient preferences into clinical trial design?
  • How can we build partnerships to collect this information?
  • How can we use data on patient preference for post-market and compliance issues?
  • What disease areas or device types are best suited for the patient preference approach?
  • Which diseases or device types are best suited for patient preference input?
  • How can we ensure that patients, families and caregivers are well informed so that they understand the choices they have and the decisions they are making? 

We also announced that we will be establishing a new Patient Engagement Panel as part of our Medical Device Advisory Committee to provide advice on issues important to patients, such as more understandable labeling and the use of medical devices at home. 

Throughout the workshop, it was clear that determining the benefits and risks of medical devices is one of the most important things we do. 

In 2012, the FDA published a document to help industry understand the key factors we consider when making benefit-risk determinations for certain medical devices. Importantly, it discusses collecting patient-centric metrics to measure benefit and ways of measuring a patient’s tolerance for risks. 

But the last two days have been all about the patients who may need these products, the caregivers who would be helping patients use them, and the health care professionals who may prescribe them. What do they want? What do they need? 

The FDA is committed to giving patients in the United States access to safe and effective medical devices of high quality and we work hard to improve the predictability, consistency and transparency of the pre-market review process. We’re pleased at the progress we’ve made over the last two days as part of our effort to invite patients into the regulatory process, and we look forward to more close collaboration with patients in the future. 

Patients, after all, are at the core of our mission and the focus of our vision. 

Michelle McMurry-Heath, M.D., Ph.D., is the Associate Director for Science at the FDA’s Center for Devices and Radiological Health

Identifying Medical Devices Will Strengthen Safety

By: Jeffrey Shuren, M.D., J.D. 

Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doctors in hospitals, while others are used by patients in their home or at work. 

Nevertheless, it may surprise you that unlike consumer products and medications, many medical devices do not have a unique identifier that unambiguously distinguishes one product from another. 

This is about to change. FDA is implementing a new system that will provide a consistent and standard way to identify medical devices throughout their distribution and use. 

It is called the Unique Device Identification (UDI) system. Most devices may be required to have a code on their label and packaging, and for certain devices, on the product itself, in plain text and a machine-readable format, like a bar code. This code will correspond to the specific model or version of a device and will include production information, such as the lot number and expiration date. 

It will also provide a link to a publicly available database – called the Global Unique Device Identification Database – where you can find information about some of the devices’ key characteristics, such as model and brand – but no identifying patient information will be stored there. 

FDA worked with the health care community and the device industry to develop a system that will provide a clear way of documenting device use in electronic health records and clinical information systems. 

Companies, health care professionals and patients will be able to report medical device adverse events more accurately. And recalls will be faster and more effective. When there are critical issues with a medical device, the UDI could be specified in safety alerts and recall notices. Health care professionals would be able to rapidly identify patients who have or are using the recalled device. At the same time, similar devices not implicated would not be taken out of use in a broad attempt to remove potential hazards. 

Implementation of the UDI system will take place over several years, beginning with devices that pose higher risks to patients – such as heart valves and hip prostheses (also known as artificial hips). Other devices, such as powered wheelchairs and blood glucose meters, will follow. 

This is a landmark step for FDA. UDI may be an acronym for Unique Device Identification, but what it really stands for is better patient health. 

Jeffrey Shuren, M.D., J.D., is the Director of FDA’s Center for Devices and Radiological Health 

Reaching Out to Europe on Food Safety

By: Michael R. Taylor

After trips to the Pacific Northwest and New England to connect with growers and state partners on produce safety, I traveled last week to Europe to talk with our regulatory counterparts and others about what the proposed rules under the Food Safety Modernization Act (FSMA) mean for countries that export food to the United States. In Europe, the focus was on all four of the rules we have proposed so far, including two rules proposed in July that implement the Congressional vision of achieving greater importer accountability for food safety.

The U.S. delegation meets with Dutch colleagues at the Port of Rotterdam, the largest seaport in Europe. Jack Vera (center), head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, discusses with Mike Taylor and others procedures required by the European Union for conducting product checks and for sampling and testing product at the Border Inspection Post.

Food safety is a critical issue for all of us in today’s global food system. For consumers in the U.S., there’s a good chance that the food they are eating is imported. Fifteen percent of all the food we eat each year comes from other countries and the percentage is much higher for certain commodities, like fruits and vegetables, seafood and spices. American consumers want to know that imported food is as safe as food produced here.

U.S. food producers and processors also have a stake in the safety of food and ingredients from overseas and rightly want to know that there’s a level playing field – that imported food would have to meet the same safety standards as food produced in the U.S. under the new food safety rules. And it makes sense that European firms and governments are interested in the FSMA requirements we are developing because they want to maintain market access in the U.S.

Our first stop was in Grange, Ireland, just outside Dublin, where the European Union’s Food and Veterinary Office (FVO) is housed. FVO oversees the national food safety inspection programs conducted by the EU’s 28 member states. We had a full day of detailed discussion with FVO director Michael Scannell and his team about FSMA and the opportunity to collaborate on its implementation. The opportunities are great and are important for the U.S. and Europe if we’re to achieve both effectiveness and efficiency in food safety oversight.

There are some differences in how Europe approaches food safety oversight but what was striking to me was that many of the overarching principles that guide us are so similar. In the Netherlands, our second stop, a presentation by Dr. Ron Dwinger from that country’s Food and Consumer Product Authority emphasized basic principles that are very familiar to all of us – a focus on prevention, the importance of addressing food safety from farm to table, the need to base strategies on risk, and the importance of industry responsibility. It was obvious to me that all of us are talking the same language and that food safety reform is a global movement.

While in the Netherlands, my FDA colleagues and I visited the Port of Rotterdam, which is the largest seaport in Europe. The fact that it is a major gateway to the European market for food commodities from around the globe really showed the scale and complexity of today’s modern food system. We were briefed by Jack Vera, head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, about their procedures and strong safety controls over what comes into the country, and we witnessed the sampling of frozen tuna from a large container that originated in Ecuador.

We moved on to Brussels for a critical meeting with our EU regulatory counterparts from DG Sanco, an arm of the European Commission that sets food safety policy and standards for the EU. FDA has had a very positive, ongoing relationship with Paola Testori, the head of DG Sanco. She is a strong leader for consumer protection and a staunch proponent of trans-Atlantic partnership on food safety, including FSMA implementation. Her direct and candid style will help ensure we fulfill our common vision.

We then held a public listening session in Brussels, where we found the same diversity of stakeholders and questions that we expect back home – from government, industry, and consumer groups. Those participating at the meeting represented both the EC and some of the EU member states.

Finally, after traveling to three countries in three days, we left Brussels for Geneva, where we visited our colleagues in the food safety program at the World Health Organization, who play a key role in assuring the scientific quality of international food safety standards, established by the Codex Alimentarius Commission of the United Nations, and in building the food safety capacity of developing countries.

The last stop of our trip was at the World Trade Organization (WTO) headquarters, which sits on the shore of the beautiful lake straddled by the “old” and “new” Geneva. We met there with Gretchen Stanton, who oversees implementation of WTO agreements related to trade in food, and her colleague Melvin Spreij. Trade is important to the economies of developed countries but also for less developed ones, many of which want to strengthen their food safety systems so they can export to markets in the U.S. and Europe. We discussed our international outreach efforts on FSMA and how to help developing countries build their food safety capacity.

With each visit, meeting and listening session we participate in, both in the U.S. or abroad, it becomes clearer and clearer how important partnerships will be to successful food safety reform and how many willing partners we have.

The aspiration for partnership is of course the easy part. Actually building meaningful operational partnerships is much more difficult and will require sustained investment of effort and significant resources. It will be worth it though if the end result is a modern food safety system suited for our global food economy and capable of maintaining the public confidence essential to trade in food, whether domestic or international.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Next Steps on Arsenic and Rice

By: Suzanne Fitzpatrick, Ph.D., DABT 

On Sept. 6, FDA announced the results of testing 1,300 samples of arsenic in rice and rice products and found that the arsenic levels in rice do not present an immediate or short-term health risk. 

As we said last week, the next step is to assess the potential health risk from long-term exposure to the arsenic in rice and foods made with this grain. 

And that is where my job starts. I am a scientist at FDA and I’d like to explain the scientific legwork that will be done over the next few months by some of the most preeminent arsenic experts in the country. 

This is a daunting task, with one complicating factor being the sheer volume of rice products. When we conducted the risk assessment on arsenic in apple juice that led to the proposed limit, or action level, of 10 parts per billion, we were essentially dealing with one product. With rice, there are different varieties and hundreds of products made with rice. We’ve already started the work. A thorough risk assessment is underway by FDA scientists at the Center for Food Safety and Applied Nutrition, in consultation with colleagues in FDA’s National Center for Toxicological Research and in other federal agencies, including the National Institute of Environmental Health Sciences and the Environmental Protection Agency. 

Scientists and medical experts of all kinds will be working together. I am a toxicologist and will be looking at the data on possible different adverse effects from arsenic exposure in rice. Nutritionists will be studying rice consumption patterns and epidemiologists will be looking for patterns of disease. There will be statisticians, experts on exposure to arsenic, and many others. 

We will use published research on people who have been exposed for years to elevated levels of arsenic in the drinking water. Importantly, we will be looking to see how arsenic may affect the youngest and most vulnerable among us. 

This analysis will take time. As it progresses, the rice industry, university researchers, and the U.S. Department of Agriculture are working to identify ways to reduce arsenic levels in rice during production. This is important because we want to minimize exposure to contaminants like arsenic in our foods whenever feasible. 

In the meantime, let me repeat FDA’s advice to eat and to serve your family a balanced diet that contains a variety of grains, including wheat, barley and oats. Consistent with advice long given by the American Academy of Pediatrics (AAP), we recommend that infants and young children eat a variety of grain cereals for good nutrition. According to AAP, there is no medical evidence that rice cereal has any advantage over other cereal grains as a first solid food. 

My colleagues and I are scientists, but we’re also consumers and parents ourselves. It is our responsibility – our mission –  to put forth the best possible science on this issue – to understand and minimize any long-term risk from the presence of arsenic in rice and foods made with rice. 

Dr. Suzanne Fitzpatrick is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

Thinking Globally to Strengthen Science and Public Health Locally

By: Margaret A. Hamburg, M.D.

There are many good reasons to go to Arkansas in September. To visit Little Rock, nestled in the rolling hills between the Ouachita Mountains and the Arkansas River, and recently chosen as America’s number one most livable city. To attend the Annual Eureka Springs Antique Automobile Festival or the Ozark Quilt Festival. Or to take in the William Jefferson Clinton Presidential Library in Little Rock or visit his childhood home in Hope. And yet, none of these were the prime rationale for why more than 100 scientists, researchers, government regulators, and students from around the world came to this state. Instead, these committed individuals traveled from places as far away as Brazil, South Korea, and Australia to attend the Third Annual Global Summit on Regulatory Science hosted this week by FDA’s National Center for Toxicological Research (NCTR). 

Margaret Hamburg, M.D.They were here to help plan and build an organization to ensure that at a time of growing global demands and pressures, we can more efficiently turn the extraordinary potential and promise of science and technology into real-world products and programs that matter and make a difference to the public health.

The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise and of FDA’s work and mission, regulatory science. Regulatory science is critical to speeding innovation, improving regulatory decision-making, and strengthening our ability to better assess the safety, quality and efficacy of a wide range of products, including food, drugs and devices. It is the work of regulatory science that truly enables us to have the knowledge and tools needed to translate scientific discovery and innovation into the products that hold such great promise.

That’s why one focus of the meeting was how to build a training model for regulatory scientists. Because even when individual nations have high standards for scientific training, fully leveraging the opportunities in science today requires an added focus on the specific critical thinking skills necessary to design, implement, and interpret studies within the regulatory context.

A number of programs at FDA for instance, are helping to ensure that scientists – both at the agency and around the globe – have this foundation. For example, NCTR has been collaborating with various Arkansas universities for a number of years to offer research training opportunities through a fellowship program that offers research training to postdoctoral students, as well as a training program for summer interns at the undergraduate level. So far, these programs have helped train students from more than 47 countries, as well as within Arkansas and across the nation.

One program I am especially excited by is the Arkansas Center of Excellence in Regulatory Science (ACERS), a public-private partnership that grew out of a Memorandum of Understanding I signed with the State of Arkansas in 2011. The five research universities that are part of the MOU are working collaboratively to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities of NCTR and FDA to develop a powerful public resource. And just this week, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the work of the Center, by facilitating the transfer of NCTR technology to the private sector.

Another important forward-looking aspect of ACERS is the creation of the Program in Regulatory Sciences at the University of Arkansas for Medical Sciences. This curriculum will help provide both current graduate students – and their broader scientific communities — with the critical skills needed to apply their scientific expertise to the decision-making needed for regulatory science within their specialties. These students represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation.

All of this speaks to the second important principle at the center of this week’s gathering in Arkansas – strengthening opportunities for collaborations being built among scientists from different governments, academia, industry, and elsewhere. Quite simply, collaboration is a cornerstone of regulatory science.

FDA increasingly is required to act in an environment in which food and product safety and development know no global boundaries. To respond effectively we must strengthen collaboration among international partners. This will allow us to offer a unified focus on regulation in the name of science to help ensure the availability and safety of the supply of food, drugs, and other products around the world.

The discussions this week in Arkansas furthered the development of innovative technologies, approaches, and, perhaps most significantly, partnerships that enhance the use and translation of basic science into regulatory applications, as well as new collaborative systems for communication, education and training. These efforts offer extraordinary promise for the future of regulatory science in the global context and for the delivery of the kinds of innovative, safer and more effective products that patients and consumers expect and deserve.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

Crafting better drug labeling to ensure safer use of opioids

By: Margaret A. Hamburg, M.D.

One of the FDA’s primary public health missions is ensuring that healthcare providers and their patients have all the information they need to help decide whether a medication is safe and appropriate to use.

Margaret Hamburg, M.D.Communicating the full risks and benefits of a drug becomes all the more important for those medications that are potentially deadly if used incorrectly. Extended-release long-acting(ER/LA) opioids fall into that category, and can sometimes cause serious harm, like addiction, even when used properly.

These medications, which include drugs such as morphine, oxycodone, and fentanyl, can improve the quality of life for many people who must live every day with pain. But ER/LA opioids often also contain a large amount of the active ingredient, sometimes in sufficient quantity to be lethal, and they are a prime target of drug abusers.

As part of FDA’s efforts to address the serious risks of ER/LA opioids, we looked more closely at the product labeling, known by many as the package insert, to determine whether this essential tool for conveying information about a drug should be revised to encourage safer use.

We closely reviewed medical literature and evaluated public input. We then came to the conclusion that if we improved what the labeling says about proper patient selection and the risks from these drugs, we might be able to reduce the frequency of bad outcomes.

And so today I’m pleased to announce new, proposed labeling changes for ER/LA opioid pain relievers, as well as new postmarket requirements that will include additional studies and clinical trials to better assess certain significant questions about the risks and safety practices of these drugs. The goal is to achieve safer and more appropriate use of these potent pain relievers.

These labeling changes better describe the risks associated with the ER/LA opioid medications and clarify the population for whom the benefits of these products outweigh their risks.

Rather than stating that these medications are indicated “for the relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time,” once final, the updated label will clarify that these products are indicated for “management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

And in the section of the label regarding limitations of use, we have added language plainly stating just how risky these drugs are — even at recommended doses.

In addition, we are requiring changes to the boxed warning for these products to give greater emphasis and prominence to the risk of Neonatal Opioid Withdrawal Syndrome that may occur in newborns due to prolonged opioid exposure during gestation.

We know that the way a patient characterizes pain is always going to be subjective: “moderate” pain for one patient may be “severe” pain to another. And we recognize that there are some women who have an appropriate need for opioids during their pregnancy.

The goal of all of these labeling changes is to help physicians work with their patients to determine whether these potent pain relievers are the most appropriate treatment for their specific situation and if so, to help them in managing their use.

While our intent is to encourage safer and more appropriate use of these products, simply changing the labeling won’t make an impact if these changes are not understood and integrated into practice by healthcare providers. So I am urging prescribers to spend some time going over this new labeling, when final, reflecting on what the language means to their practice, and communicating what they’ve learned to their patients.

The fact is, improving the safe and appropriate use of ER/LA opioids takes the help and commitment of all of us, including our partners in the healthcare community. We are committed to working together to help ensure that healthcare providers can prescribe ER/LA opioids properly and better monitor and educate their patients.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

CFSAN: Pinpointing Priorities, Protecting the Public Health

By: Michael Landa 

When I started my first tour with FDA in 1978, I could not have foreseen the challenges we would face today in our mission to protect and promote the public health. 

Who could have predicted the expanding globalization of the food supply? Or the extent to which technology would transform the foods and cosmetics industries and the ways we regulate them? Who knew that today many consumers would be committed to eating fresh, minimally processed, locally sourced foods? 

As director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, I have seen these and other developments in the shifting landscape of food and cosmetic safety. And I am responsible for helping to establish the priorities that will guide our work. 

To this end, I am pleased to share with you the CFSAN Plan for Program Priorities, 2013-2014. The two-year plan – which is well underway at this time – identifies six key program goals and details how we will achieve them. The goals are: 

  1. Reduce foodborne illness rates and cosmetic injury rates each year.
  2. Establish regulations, policies, guidances, and inspection and compliance strategies based on the best science and strategies for prevention and minimizing public health risk.
  3. Increase compliance with new controls focused on preventing foodborne illness and other health hazards. This includes promoting best agricultural practices to farmers, educating consumers on safe food handling practices, and ensuring that safety standards are consistent for both foreign and domestic foods and cosmetics.
  4. Implement science-based strategies that facilitate healthy diets.
  5. Develop and swiftly deploy the fastest, most effective methods for identifying, containing, and eliminating food and cosmetic hazards.
  6. Achieve optimal use of staff and resources. This includes strengthening leadership and management capabilities, enhancing relationships with other regulatory entities at home and abroad, and reviewing and clarifying administrative roles and responsibilities. 

This is not by any means an exhaustive list of all CFSAN initiatives. The Center is continuing other important work that includes reviewing manufacturer premarket notifications for infant formulas; carrying out pre- and post-market regulation of food ingredients and packaging; monitoring for the presence of chemical contaminants in regulated products; authorizing health and nutrient content claims on food products; seeing to it that violative product labeling for cosmetics is corrected; and reviewing premarket notifications for new dietary ingredients in dietary supplements.  

We remain focused on dedicating our resources – human and otherwise – to meeting all of these goals and responding to the challenges ahead.

I encourage you to look at the strategies we will use and the regulatory blueprints we will follow to ensure that the foods you eat and the cosmetics you and your family use are safe. 

Michael M. Landa is Director of FDA’s Center for Food Safety and Applied Nutrition

On Farms and in Labs, FDA and Partners Are Working to Get Answers on Arsenic in Rice

By: Margaret A. Hamburg, M.D.

This week, my colleagues and I traveled to California to learn more, first-hand, about the presence of arsenic in rice.

FDA Commissioner Margaret Hamburg and Deputy FDA Commissioner for Foods and Veterinary Medicine Michael Taylor, center, don hip waders to go out into the rice fields at Lundberg Family Farms in Richvale, Calif. At left is Bryce Lundberg, the farms' vice president of agriculture, and at right is Mike Denny, vice president of farming operations.

This grain, like other foods, contains traces of arsenic, a chemical element found in water, air and soil. However, rice plants absorb more arsenic than most other crop plants. FDA has been monitoring arsenic levels in foods, including rice, for decades.

On Wednesday, Sept. 4, we toured a research facility in which scientists are working to find ways to improve the quality and safety of rice. And we visited the historic farming community of Richvale — a short drive north of Sacramento — known as the birthplace of California rice.

In each of these places I saw a true commitment to public health and a shared goal of ensuring that any risk is minimized so that people around the world can continue to eat rice and rice products as part of a varied diet.

Today, FDA released the results of tests performed on a total of more than 1,300 samples of rice and rice products. What we found was that the levels of inorganic arsenic are well below the levels that would result in any immediate or short-term health risks. This information will now be considered by FDA in looking at the potential long-term health effects associated with the consumption of arsenic in rice and rice products.

Our visit to California, at the invitation of the rice industry – including the USA Rice Federation – was FDA’s third fact-finding visit to rice-producing states, the earlier trips being to Arkansas and Missouri. My traveling companions included Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Andy Hammond, regional director of the U.S. Department of Agriculture’s Agricultural Research Service (ARS).

Our first stop on Wednesday was at the Rice Experiment Station in Biggs operated by the California Cooperative Rice Research Foundation. Research at the station is funded in large part by assessments on rice growers and involves close collaboration with experts at the University of California/Davis and ARS.

Touring the station’s research fields gave us a sense of the determination by all involved in this work, including industry, to better understand how arsenic gets into rice and what growing and processing strategies might be employed to reduce arsenic levels.

That afternoon we visited two multi-generation family farms in Richvale. Lyle Job and his family have been farming their land for more than 30 years. At the Lundberg Family Farms, in business since 1937, we learned about the different approaches of organic rice farmers.

These farmers take enormous pride in their work. They told us about the soil and climate conditions that make their land ideal to grow rice. At the Job farm, we climbed up into a huge harvester to see how it operates. At the Lundberg farm, we put on hip boots and waded out into flooded fields.

Standing beside these farmers, I was struck by their commitment to making the best product possible and the intensity of their desire to help us understand the challenges they face. Rice is not just a commodity to them; it’s their way of life.

Our last stop, on Thursday, Sept. 5, was to FDA’s laboratory in Alameda, where hundreds of rice samples were tested using a process called “speciation.” FDA scientists developed the speciation method used to measuring total arsenic levels, but most importantly to measure both the organic and the more toxic inorganic forms of arsenic.

So what does this all mean right now? As a mother I can imagine that many of you are asking yourself, “Should I be feeding it to my children?” Our best advice – consistent with that given by the American Academy of Pediatrics – is to eat a well-balanced diet that includes a variety of grains.

We don’t have all the answers yet, but we’re working on it. In collaboration with farmers, industry, academia and other public health agencies, we are doing everything possible to determine if the levels of arsenic in rice pose a long-term health risk and, if so, what can be done to reduce that risk.

The presence of arsenic in rice is a global health issue. The answers we seek will ultimately help protect consumers all over the world.

For more photos of our tour, visit Flickr.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

FDA Builds on Experience and Cooperation to Respond to Foodborne Illness Outbreaks

By: Kathleen Gensheimer, MD, MPH

Two years ago, FDA put the Coordinated Outbreak Response and Evaluation (CORE) Network in place to improve the response to outbreaks of foodborne illness. In fact, the very day FDA announced the group’s formation, CORE was already responding to one of the deadliest foodborne illness outbreaks in decades. Sadly, that outbreak of Listeria monocytogenes linked to cantaloupe caused 33 deaths. However, through the coordinated efforts of the FDA, the Centers for Disease Control and Prevention (CDC), and state and local governments, the outbreak was stopped and lives were saved. 

Recently the New England Journal of Medicine published an article on that outbreak, so I thought I should revisit FDA’s role in the response and its actions to help prevent future outbreaks like this.

Just before the Labor Day weekend in 2011, Colorado state health officials announced that the number of listeriosis cases in that state was three times more than normal for August. FDA worked with the CDC and state partners on the issue and it was suspected that illnesses, spread over several states, might be linked to Colorado-grown cantaloupe. 

FDA quickly mobilized its field investigators and subject matter experts. Cantaloupe samples FDA collected from stores were found to be contaminated with Listeria monocytogenes. FDA reviewed records to determine the potential growers of these cantaloupes. Investigators from FDA and the state of Colorado inspected one of these growers, Jensen Farms, and collected cantaloupe samples and swabs of surfaces at the Jensen Farms packing house. Those samples were found to contain Listeria monocytogenes with the same DNA fingerprint that had been isolated from people who became ill. Shortly afterwards, Jensen Farms began a product recall. 

While FDA monitored recall activities, it also coordinated an environmental assessment at Jensen Farms. With Jensen Farms’ cooperation, experts in food safety, health, and agriculture from FDA, CDC, the Colorado Department of Public Health and Environment, the Colorado Department of Agriculture, and the Prowers County Department of Health worked to identify conditions or procedures potentially contributing to the outbreak. 

This team found, among other things, that the packing house floor allowed water to pool, the design of equipment made it difficult to clean and sanitize, and the temperature of the cantaloupe when they were refrigerated allowed moisture to form on them and may have allowed bacteria to grow. To inform the food industry and help them avoid similar problems, FDA made these findings public. As a result, the industry took a number of steps to enhance cantaloupe safety, one of which was to issue updated national food safety guidelines for cantaloupes

In addition, this year FDA initiated inspections and sampling at cantaloupe packinghouses in the United States to assess the current practices and conditions that may affect the safety of cantaloupe distributed to consumers.

Since that first test of FDA’s improved foodborne outbreak response, FDA has responded to more than 80 outbreaks of varied scope, severity and complexity.   

For example, in an outbreak linked to scrape tuna in sushi, a product recall protected consumers from more than 58,000 pounds of tuna that was potentially contaminated with Salmonella. In another outbreak related to Salmonella in peanut butter, we used a new authority granted by the FDA Food Safety Modernization Act (FSMA) to suspend the registration of a food processor, which effectively prohibits the distribution of potentially unsafe food domestically or abroad. 

Over the past two years, we have learned what works best and improved procedures to continue to protect consumers from contaminated food. That progress would not have been possible without the close collaboration with our many partners at the local and state public health and agriculture level, as well as with our federal partners within CDC, U.S. Department of Agriculture and FDA. 

We look forward to continued partnership and progress in the years to come. 

Kathleen Gensheimer, MD, MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response