Ensuring Safe Food and Medical Products: A Partnership with the Mekong Region

By: Margaret A. Hamburg, M.D.

Several years ago I had the opportunity to visit the Mekong Region of Southeast Asia, which includes the countries of Cambodia, Laos, Myanmar, Thailand and Vietnam. I was struck not only by its beauty, dynamism, and diversity, but also by the commitment of health officials there to building strong health systems and cooperating across borders in the face of potential health threats. I learned that by working together with each other and the United States they were able to build an effective rapid response to outbreaks of an emerging pathogen such as the H5N1 influenza virus.

Margaret Hamburg, M.D.I was reminded of my visit this week during my participation at a forum hosted by the Center for Strategic and International Studies entitled “U.S. Health Partnerships in the Mekong Region.” The day’s discussions highlighted the growing strategic importance of the region to the United States and the long-standing and ongoing partnerships between U.S. agencies and regional partners in health and development, including the central focus of the FDA, to ensure the safety of food and medical products in the United States.

Though Americans may not often think about it, the U.S. is increasingly and inextricably linked to the Mekong Region through global supply chains. For instance, about 15% of the seafood we consume in the United States comes from Mekong region countries, arriving on our shores and in our stores after a long and circuitous journey. Consider tuna, which may be caught in the South Pacific, transported to New Zealand for pre-canning, and shipped to Southeast Asia for canning before it finally makes its way to the East Coast of the United States for distribution in this country. 

Why does this matter to FDA? There is a greater likelihood that food will be exposed to pathogens, contaminants or chemical hazards during a journey of this complexity. That’s why we work closely with our regional counterparts in these countries through such organizations as the Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic Cooperation (APEC), sharing with them our own regulatory requirements, our knowledge of good manufacturing practices and our laboratory and inspection techniques. Through such information sharing we believe we can prevent tainted or otherwise unsafe foods from reaching our borders. 

But the risk of potentially unsafe food from this area is not our only concern. A significant threat to human safety today involves substandard, falsified and counterfeit medical products that are part of the global supply chain. These products may contain toxic ingredients, or too much or too little of a drug’s active ingredient, and as a result patients could be poisoned or unwittingly receive inadequate treatment for their disease or even no treatment at all. In addition, if too many patients receive only partial treatment, it might foster the development of drug-resistant disease strains. And there’s this too: a high prevalence of substandard and falsified medicines ultimately will erode public trust in the health care system.

Unfortunately, statistics suggest that substandard and falsified products is a problem in the Mekong Region. A recent comprehensive review found that in Southeast Asia, 35 percent of anti-malarial drugs were substandard and 36 percent were counterfeit. And many of the countries in this region have porous borders and face challenges with regulatory oversight and enforcement practices that cannot adequately protect the supply chain. 

FDA is working with the World Health Organization to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system. In addition to cooperating with our regulatory counterparts across the globe on issues of detection, investigation and enforcement, FDA scientists have developed the Counterfeit Detection Device, or CD-3, which can quickly screen for counterfeit products – not just drugs – at any location, including remote communities and border sites. With our international partners, we are currently planning to expand the use of this tool in several field settings, including in the Mekong region.

Building cooperation for this kind of enforcement is essential not just to ensuring the safety of our food and medical products, but as a means of advancing our national security objectives. That’s why meetings like the one I attended this week are so important. They support opportunities to work with our colleagues in the Mekong region on ways to share information and promote stronger, innovative regulatory systems that are critical to the long-term success of our global public health efforts.

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

Getting Importers’ Pulse About Food Safety Plans

By: Michael R. Taylor

My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year.

We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors - would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.

Members of the import community and food industry attended a public meeting on proposed rules designed to keep imported foods safe.

Earlier this fall, we had our first public meeting on the proposed import rules in Washington, D.C., that was attended by a diverse audience, including consumer and public policy representatives. In Long Beach, the audience was predominantly members of the import community and food industry around the world – including public and private officials from Japan, Thailand, Mexico, Canada and Barbados. Global impact was a thread that wove through all the discussions.

We were very pleased to have with us Sandra Schubert, undersecretary for the California Department of Food and Agriculture, who emphasized the importance of these rules to a large importing and exporting state like California. Across the country, the states will play a very important role in making the food-safety rules a reality.

We learned how the complexity of the global food supply chain could make implementation a challenge. For example, the owners of specialty food stores may have a comparatively small volume of food, but they use many different suppliers around the world. (One Italian foods retailer said that he uses 38 different suppliers in Italy.) They are concerned about the difficulty of requiring all of their small-scale suppliers to verify that the foods are produced in a manner consistent with U.S. standards.

Their complaint is similar to those voiced by small farmers facing a proposed rule that would create new safety standards for the produce industry. They too are afraid of being overwhelmed by logistics and expenses that could put them out of business. As with the produce rule, there are exemptions for small businesses and suppliers. However, some of the specialty importers feel that those exemptions should be expanded.

I was impressed that many of those who spoke at the meetings are thinking ahead to the nuts and bolts of implementation. They asked, however, how we will keep the playing field level – holding all importers and exporters to the same standards. They’ll be at a financial disadvantage if they’re following the rules and others aren’t.

We’ll consider that, and we’ll keep talking. There is clearly no “one size fits all” solution. We want to meet our safety goals with practical, feasible regulations that will work across the wide diversity of food operations.

From Long Beach we drove north to Bakersfield, where we met with growers to discuss the proposed produce regulations. These farmers produce an incredible diversity of crops, including citrus fruits, table grapes, almonds, carrots, leafy greens, green peppers and many more.

We learned a lot in this visit to California. Everything that we heard will be carefully considered as we work on the final version of these rules.

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

A New Plan for Drug Shortages to Build on FDA’s Success

By: Capt. Valerie Jensen, R.Ph. 

I’ve led FDA’s efforts to address hundreds of drug shortages for more than 10 years. During that time, we’ve made progress. Just last year, we cut the number of new shortages by more than half. But more work needs to be done. 

In an effort to enhance FDA’s current approach to drug shortages and bring new ideas to reduce the number of patients who are affected, we provided Congress today with a strategic plan aimed at enhancing efforts to prevent and reduce drug shortages. FDA is actively working, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, to address the public health threat caused by critically needed medications being unavailable for patients. And we will continue that work and build on our progress. 

An important part of our work is understanding the impact on patients. I’ve talked with many patients and caregivers about the effects of drug shortages. It deeply saddens me to hear a mother talk about her new baby boy, born prematurely, who is struggling to survive due to the scarce supply of drugs to meet his nutritional needs. Or a husband whose wife has been battling cancer and her doctor says the hospital is running out of the medication needed to properly treat her. 

I’m often asked, “Why do drug shortages persist?” and “Why are so many lifesaving drugs in shortage?” The majority of these problems stem from quality and manufacturing problems. Therefore, the answers boil down to quality manufacturing. 

While “quality manufacturing” may sound like a simple concept, getting there is a complex process – and one in which FDA and outside stakeholders have important roles to play. 

The strategic plan includes a number of new ideas to address shortages. Many of these strategies focus on enhancing FDA’s response and communication when we become aware of quality or manufacturing issues that could lead to a shortage. Other strategies that FDA is considering include the development of new risk-based approaches to identify early warning signals for manufacturing and quality problems that could lead to production disruptions.

In addition, the strategic plan identifies some preventive measures companies can take that place a greater emphasis on manufacturing quality and stability of supply, thereby eliminating the root causes of most shortages. 

Better manufacturing quality will help eliminate drug shortages over the long-term. But when a manufacturing disruption is likely to occur, early notification by manufacturers is critical. Along with the strategic plan, therefore, FDA is today issuing a proposed regulation implementing the expanded early notification requirements included in FDASIA. This regulation would require that all manufacturers of certain medically necessary prescription drugs give FDA advance notice of a permanent discontinuance or a temporary interruption of manufacturing. It would also extend this requirement to manufacturers of biologic products. 

Advance notification of a potential shortage allows FDA to work closely with manufacturers on the underlying issues, and in many cases, we are able to prevent the shortage. 

FDA envisions all stakeholders coming together to ensure patients have access to the safe, effective, and high-quality medications they rely on and deserve, and we believe the strategic plan we presented to Congress today will make great strides in ensuring that happens.

Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research

 

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.

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

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 Systems Recognition: Ensuring Imported Foods Are Safe

By: Julie Callahan

FDA works on many fronts when it comes to making sure our food supply is safe—not just the foods we grow and process here in the United States, but also those that are shipped here from overseas.

And there are many. In fact, imports of food to the U.S. have more than doubled in the past decade.      

FDA has systems in place to help ensure that foods imported are as safe as those produced in the U.S., and under the FDA Food Safety Modernization Act (FSMA), consumers can have even more confidence in the safety of imported food.  Under FSMA, FDA is setting standards for domestically produced and imported foods that would prevent contamination and is requiring that importers verify that their overseas suppliers are producing food consistent with these requirements. 

But FDA has even more tools in its toolbox to make imported food safer. For example, FDA is working with countries to build their capacity so that their food safety systems improve. FDA also wants to recognize countries that are so reliable that we can consider them “comparable.” 

New Zealand is the first country with which FDA completed a systems recognition assessment, and we signed a systems recognition arrangement with its food safety authority, the Ministry for Primary Industries, in December 2012. Today, we published “Information for Foreign Governments: Frequently Asked Questions on Systems Recognition,” to provide more information on this topic.

Recognition under this new program, which we continue to pilot test, is a high bar to reach. These are countries that have preventive, risk-based programs in place and can respond and follow up on any food safety incidents that may occur. In recognizing countries under this program, we want assurance that the country’s authorities will be able to swiftly track down the source of a foodborne illness and take corrective actions as necessary to stop it in its tracks—and to help prevent such an incident from happening again. 

If a country does not have a systems recognition arrangement in place it can still export products to the U.S. However, participating in a reciprocal systems recognition arrangement with the FDA offers countries that have very robust food safety control systems an opportunity to participate in a closer regulatory partnership. For example, with New Zealand, we can use some of the data they generate to help us make decisions about their imports. We can also use systems recognition determinations as one factor in prioritizing resources dedicated to foreign facility inspections, import field exams, and import sampling. 

As we tackled ways to identify the top-performing food safety systems in an objective, transparent, and importantly, reproducible way, we first looked at the way that we evaluate our own food safety programs in every state. In doing so, we developed the International Comparability Assessment Tool (ICAT). The ICAT is based on the approach that we use here in the U.S.; that is, evaluating all aspects of the system, from the regulatory foundation, to training, inspection, compliance programs, and how outbreaks and trace-backs to identify the contaminant are conducted.

Under systems recognition we assess a country’s entire food safety control system, from soup to nuts and every other food that FDA regulates. Of course, how things look on paper doesn’t always reflect how they work in practice. So we include on-site reviews as part of the systems recognition assessment process, to see first-hand how a country implements the programs they’ve described in the ICAT. It’s the difference between actually using a Smartphone and just reading the user manual.

Why New Zealand? In the past, New Zealand and the U.S.had certain commodity-specific arrangements in place, such as ones for seafood and certain dairy products. Our next scheduled review of these arrangements coincided with the time FDA was starting to develop its systems recognition program. As we were already working closely with New Zealand to update these arrangements, it made sense to expand our review.

Here’s where things get interesting.

Recently, you may have seen New Zealand’s food safety system in the news, associated with a potentially contaminated whey protein product commonly used in infant formula and sports drinks. Although the product had not been exported to the U.S., the New Zealand authorities discovered that a package of 21 candy bars containing whey protein from the potentially dangerous batch had been sent to a company here for market testing. As soon as they identified the product, they contacted FDA to let us know that they had traced it to a particular company and had contacted the company. They made sure that the product had not been sold to any consumers in the U.S. and accounted for all of the candy that had been shipped here.

In the end, the whey protein that was recalled had not been contaminated after all—it proved to be a false alarm. 

New Zealand authorities had acted swiftly and effectively, exhibiting a level of detail, commitment to communication, and sophistication that confirmed FDA’s assessment of their food safety system. The New Zealand authorities brought the same care to notifying other countries that had received the recalled product, as well as any other product that contained the whey protein as an ingredient.

Currently, we are in the process of piloting another systems recognition assessment with Canada, and we hope to expand our effort to more countries in the near future. As we move from the pilot phase towards implementing a new program and identifying additional countries with food safety systems that are comparable to our own, we will continue to strengthen our regulatory partnerships and focus our resources where most needed, to ensure that consumers in the U.S. can feel safe, whether their food was grown here in the U.S. or far away across the globe.

Julie Callahan, Ph.D., is an International Policy Manager in FDA’s Center for Food Safety and Applied Nutrition.

Proposed Rules Will Strengthen Global Food Safety

By: Margaret A. Hamburg, M.D.

It’s a small world.

Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

Margaret Hamburg, M.D.That’s why it’s so important that we do everything we can to help ensure that foods exported to the United States are safe for you and your family. To that end, two new rules that we propose today focus on preventing food safety problems before they happen.

These rules would make importers more accountable for food safety, and would enhance our ability to monitor conditions and standards in foreign facilities that produce and process food.

While we will continue to rely on inspections at U.S. ports of entry to keep contaminated foods from entering our country, under these proposed rules, we will significantly enhance our ability to identify issues before food gets to our shores.

The bipartisan Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, calls for a new level of accountability for everyone involved in the food supply chain, even if that chain begins halfway around the world.

So, in accordance with FSMA, we are proposing these rules:

  • The Foreign Supplier Verification rule will require importers to verify that foreign suppliers are producing food in a manner consistent with U.S. standards. Under the proposed rule, in general, importers would be required to identify potential hazards associated with each food and verify that appropriate steps have been taken to adequately control those hazards.
  • The Accredited Third Party Certification proposed rule would establish a system to strengthen the quality and credibility of safety audits and certifications for food exported to the United States.

These two proposed rules build on two other FSMA rules proposed earlier this year focused on ensuring the safety of produce and food facilities.

In the century that has passed since President Theodore Roosevelt signed the Food and Drugs Act of 1906, food safety has been a driving force for FDA and part of our core mission.

We know that to protect American consumers, our work doesn’t stop at national borders. The world may be changing, but FDA’s mission to continue to ensure the safety of the food supply for you and your family has not.

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

FDA’s Special Agents: On the Job to Protect the Public

By: John Roth

As noted in my previous three posts, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Our top-flight special agents –who have investigative authority similar to other federal law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field operations. 

Who are these special agents? They are federal law enforcement officers and they have experience: our average agent has been in federal law enforcement for over ten years, a necessary requirement given the sophistication required to work the wide range of OCI cases. 

Each special agent undergoes specialized training to be effective in their job, including firearms and personal safety training, advanced Special Agent training, and training in FDA law.  Throughout their career, OCI agents will keep up to date on the latest trends by participating in what is called “in-service training.”  Additionally, agents will take specialized training in other areas of federal law enforcement, including cybercrime investigations, computer forensics, financial tracing/asset forfeiture investigation, polygraphy, leadership and management, and advanced law enforcement techniques.

As you can see from this training regimen, we demand a lot from our agents – these skill areas are exceedingly complex. Moreover, agents must also learn such intangible skills as being able to work well with others, remain alert and focused, and hone that age-old requirement for any law enforcement officer: good instincts and a devotion to old fashioned shoe-leather doggedness. 

Our agents are located in more than 37 offices nationwide, from Hawaii to Puerto Rico, and work with law enforcement counterparts in many countries, as well as international organizations like Interpol, Europol, and the Permanent Forum on International Pharmaceutical Crime. 

No agent can go it alone, of course, and we rely on an outstanding supporting cast to help us: our “can-do” support staff, who make running a complex nationwide law enforcement program look effortless, the unmatched scientific and public health experts in the FDA centers and the civil-side inspectors and compliance officers in the field, who we rely on for help with complex, scientific cases, and finally prosecutors in the Department of Justice, who have embraced the FDA public health mission. 

My three previous FDA Voice posts highlighted several of the more significant, colorful, and sometimes tragic cases with which OCI has been involved. The first post looked at how we use our top-flight federal agents to work undercover in investigating shadowy overseas drug counterfeiters. The second post looked at high-profile instances of non-compliance right here in the United States – with our work resulting in a $1.4 billion fine. The third post looked at the callous and utter disregard for life caused by corporate actors, which necessitated a criminal response. Yes, these cases involved detailed, complex organization and a range of professional skills. 

But let me emphasize: OCI is doing this work every day. In fact, about every 30 hours, throughout the year, we are gaining a conviction, in crimes ranging from street level pharmaceutical diversion schemes to corporate fraud. In Fiscal Year 2012, OCI agents were responsible for cases that yielded over $4.9 billion in fines and restitution – monies that are paid directly to the U.S. Government or to specific victims of the criminal acts we investigate – an average of over $22 million per special agent. 

FDA’s Office of Criminal Investigation is the only federal law enforcement agency whose mission is exclusively directed at protecting the public’s health. And, criminal enforcement is a critical part of FDA’s enforcement and compliance strategy, a strategy designed to protect people from dangerous products, fraudulent schemes, and unscrupulous criminals. 

Through these four FDA Voice posts, I hope that we have made our OCI team better known to our FDA colleagues and to the public. The vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. However, OCI stands ready and on watch to locate, investigate, and bring to justice those individuals and entities who disregard and break our public health laws. 

John Roth is Director of FDA’s Office of Criminal Investigations