Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

FDA Operations Team Prepares to Implement Food Safety Laws

By: Roberta Wagner and Joann Givens

Since President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law—giving FDA new power to oversee food safety using controls that prevent, rather than react, to hazards—we have been developing an operational strategy to help prevent unsafe foods from ever being distributed.

Roberta Wagner

Roberta Wagner, Co-Chair of FDA’s FSMA Operations Team Steering Committee and Deputy Director for Regulatory Affairs at FDA’s Center for Food Safety and Nutrition.

FDA has proposed seven FSMA-mandated rules that, when final, will establish the comprehensive framework of modern, prevention-oriented standards mandated by FSMA, covering the production and transportation of human and animal foods, whether produced in the U.S. or overseas.

As co-chairs of the FSMA operations team, our job is to facilitate implementation of the food law. And we’re not waiting until the proposed rules are finalized to build the infrastructure that will be needed to support their requirements. Foodborne disease currently affects 1 in 6 Americans each year, and we can’t waste any time.

Many of FSMA’s proposed rules intersect and cover an incredibly diverse spectrum of people and companies located all over the world. Our strategy must be workable for all while protecting our food safety goals. Our team is talking to those most affected by the proposed rules—including farmers, importers, industry representatives, and state officials—for their feedback on the most reasonable and practical ways to carry out our preventive and enforcement activities.

We’re thinking about how we can encourage industry compliance with the new rules, and how we can measure this compliance. For example, we’re considering the role of information technology (IT) and how it can be used in reporting activities that will eventually measure compliance with the law.

Joann Givens

Joann Givens, Co-Chair of FDA’s FSMA Operations Team Steering Committee and Acting Regional Food and Drug Director (Central Region) in the Office of Regulatory Affairs.

Our operations team has created three workgroups tasked with implementing a multiyear strategy for compliance. Each group includes at least one state government representative. They focus on:

  • Preventive controls, considering issues such as the need to develop a trained workforce that can complete consistent, high quality inspections.
  • Produce safety and the development of performance measures.
  • Import controls and the need for goals and timelines for each phase of the two proposed rules designed to strengthen FDA oversight of foods imported into the U.S.

As co-chairs, we meet routinely with these workgroups and stay current on their progress and recommendations. We share what we learn from workgroup brainstorming sessions with Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and work with him to fine-tune operational strategies. And we meet with other federal agencies, such as the U.S. Department of Agriculture (USDA), to see what lessons can be learned from their operations.

The final timing of FSMA depends on when the rules are set, and when industry compliance dates are determined. But we’re getting the people and systems we’ll need in place now so that we’re ready to act when rules go into effect.

Our ultimate public health goal is a safer food supply and a reduction in food-related illnesses. As the proposed rules move through this period in which the public provides input, we hope that all stakeholders will continue to submit comments. Please engage with us and stay tuned for updates.

Roberta Wagner is Co-Chair of FDA’s FSMA Operations Team Steering Committee and Deputy Director for Regulatory Affairs at FDA’s Center for Food Safety and Nutrition.

Joann Givens is Co-Chair of FDA’s FSMA Operations Team Steering Committee and Acting Regional Food and Drug Director (Central Region) in the Office of Regulatory Affairs.

Johns Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation

By: Stephen M. Ostroff, M.D.

If you’ve been following my blog series about the Office of the Chief Scientist (OCS), you know about a critical component of nearly all FDA efforts to promote innovative approaches to developing and evaluating our regulated products – collaboration! This week FDA made two new additions to its network of academic partnerships known as Centers of Excellence in Regulatory Science and Innovation (CERSIs).

Stephen OstroffThe first partner brings together a team of leading scientists at the University of California at San Francisco (UCSF) in a joint effort with Stanford University. The second, Johns Hopkins University, builds on a long history of collaboration with FDA. Both partners received FDA funding through a competitive application process to establish CERSIs that will promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on FDA science priority areas.

This latest expansion of our CERSI network is an exciting development. The specialized, cutting-edge science required for FDA’s increasingly complex mission makes it imperative that we leverage available knowledge and infrastructure from collaborative partners in academia. These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence. They also enable FDA to bring its expansive experience to academia, ensuring that the new scientific approaches being developed at these institutions can be applied in a way that increases their usefulness for evaluating FDA-regulated products. And most important of all, patients and consumers will ultimately benefit from the investment.

Like those FDA previously established at the University of Maryland and Georgetown University, CERSIs are part of FDA’s effort to promote a vibrant, collaborative, regulatory science culture that enables us to tackle the scientific challenges presented by breakthroughs in medical product development and to improve food safety and quality.

As with the others, the joint UCSF-Stanford and the Johns Hopkins CERSIs will be managed by OCS’s Office of Regulatory Science and Innovation, together with teams of scientists from across FDA. Each new CERSI brings specific goals and unique strengths to enhancing FDA’s regulatory research and review.

The UCSF-Stanford CERSI will bring West Coast representation to the CERSI network and enable FDA to access UCSF’s powerhouse in quantitative sciences and pharmacology. Pre-eminent teams of scientists from both institutions and FDA scientists will be working together to develop and offer courses and workshops in drug development and regulatory science through UCSF’s American Course in Drug Development and Regulatory Sciences (ACDRS).

This CERSI will also offer scientific exchanges and training that target three of FDA’s regulatory science priority areas: transforming toxicology to improve product safety, improving clinical studies and evaluation, and harnessing diverse data through information sciences to improve health outcomes. In addition to FDA funding, the UCSF-Stanford CERSI is leveraging funds from the two academic institutions, through courses like the ACDRS, and from a recent Burroughs Wellcome Foundation Award in Innovation in Regulatory Sciences.

The Johns Hopkins CERSI will focus on three core FDA strategic priorities: clinical evaluations, social and behavioral science, and food safety. The university’s internationally recognized faculty in these areas and its geographic proximity to FDA will facilitate intellectual exchange among university faculty, FDA staff, and scientists. FDA staff can take advantage of workshops, symposia, courses, certificate programs, and a Master’s degree in Regulatory Science as well as others areas close to FDA’s strategic goals. Johns Hopkins is also known as a leader in innovative approaches to educational and life-long learning, including Internet-based courses that will be available to FDA scientists and staff worldwide.

Collaborating with our academic partners is crucial to our ability to expand the scientific foundation and infrastructure FDA needs to deliver on the promises of using 21st century science and technology to fulfill our regulatory mission.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

We’re Reinventing Ourselves to Keep Your Food Safe

By: Michael R. Taylor and Howard Sklamberg

Congress enacted the FDA Food Safety Modernization Act (FSMA) in response to dramatic changes over the last 25 years in the global food system. It grew out of an understanding that foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. And FSMA was embraced by a public whose confidence in the food system was being eroded by a series of foodborne outbreaks.

Michael TaylorThe law directs a comprehensive overhaul of our food safety system, using three broad themes:

  • Advancing Public Health – by focusing on prevention of food safety problems through broad, consistent industry implementation of modern preventive practices.
  • Leveraging and Collaborating – by working in close collaboration with other government agencies (federal, state, local, tribal and foreign), the food industry and other stakeholders to make the best use of all available food safety resources.
  • Strategic and Risk-Based Industry Oversight – including clear FDA guidance on standards; outreach and technical assistance to facilitate voluntary compliance; and the use of adaptable, risk-based inspection and compliance strategies that focus on public health outcomes and the effectiveness of overall systems of prevention.

Since January 2013, we have proposed seven new rules to establish the comprehensive framework of modern, prevention-oriented standards mandated by FSMA, covering the production and transportation of human and animal foods, whether produced in the U.S. or overseas. There is a lot of work to do to get these standards right, and we are very focused on that work.

Howard SklambergAt the same time, however, we must be laying the foundation for the next phase: effective and efficient implementation of the new standards. This requires fundamentally new approaches to collaboration and oversight to achieve high rates of compliance with FSMA’s prevention standards. And from a public health and public confidence standpoint, this is where the rubber meets the road.

We are thus pleased to be sharing with our partners and stakeholders a document that captures in broad, high-level terms our current thinking on strategy and guiding principles for implementing the produce safety rule, the preventive controls rules, and FSMA’s new import tool kit, after the final FSMA rules are issued in late 2015 and early 2016. We are making this available as the springboard for discussion with the entire food safety community.  And we know discussion is needed, because the strategy that will make FSMA a success requires significant change in how we at FDA do our work and how we work with our partners.

For example, FSMA calls for a national integrated food safety system that builds on FDA’s longstanding collaboration with state governments on food safety inspection and compliance, but we must take that collaboration to a new level, especially when it comes to the new and unique challenge of implementing the produce safety rule. We aspire to rely heavily on state agriculture departments and other state and tribal departments with on-farm food safety responsibility, taking advantage of their food safety commitment, their knowledge of local conditions and practices, and their local presence to deliver training, technical assistance and compliance oversight. But we have to work closely with our state partners to convert this aspiration to reality. That work includes finding the funding they will need to play an expanded role on produce safety and other areas of FSMA implementation.

FSMA is also helping drive internal governance change at FDA to be sure that all headquarters and field elements of our program are working seamlessly and efficiently to achieve our public health goals. You may have seen the memorandum that Commissioner Margaret Hamburg issued in February 2014 directing a more vertically integrated alignment of the program centers and the Office of Regulatory Affairs (ORA) working in particular areas, such as food safety and drug quality. This is aimed at increasing specialization across FDA, including the programs as well as frontline investigators and compliance officers. It is also intended to streamline interactions between ORA and Center experts so we can devise effective oversight plans, make well-informed judgments during inspections, and achieve timely corrective action when needed to protect consumers.

As the deputy commissioners for Foods and Veterinary Medicine (FVM) and Global Operations (GO), we share leadership responsibility, on the Commissioner’s behalf, for implementing these changes within FDA. To facilitate our efforts and share responsibility, we have created a new FVM Governance Board, which we co-chair and which includes as members: Michael  Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN); Bernadette Dunham, director of the Center for Veterinary Medicine (CVM); and Melinda Plaisier, associate commissioner for Regulatory Affairs (ORA). This Board will help ensure that CFSAN, CVM, and ORA partner fully on major strategic decisions that affect successful implementation of FSMA’s new prevention paradigm.

This is the commissioner’s vision of an agency that works seamlessly across borders, both internal and external, when it comes to protecting public health.

Finally, the work of developing detailed plans for implementing the produce safety and preventive controls rules and the new import safety system is being done by teams of FDA employees overseen by the FSMA Operations Team Steering Committee. This steering committee is led by Roberta Wagner, CFSAN deputy director for regulatory affairs, and Joann Givens, ORA Central Region, acting regional food and drug director, and it will play a key role in the dialogue we will be seeking with our government partners and stakeholder community on our FSMA implementation plans. You’ll be learning about this team’s crucial leadership role in an upcoming FDA Voice blog.

We need your engagement in this important work. Together, we can build a modern food safety system that works well for the food system and for the consumers we all serve.

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

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

The Commissioner’s Fellowship Program: A Win-Win for FDA and Public Health

By: Dr. Stephen M. Ostroff

As part of my FDA Voice blog series on the important work going on in FDA’s Office of the Chief Scientist (OCS), I’d like to highlight an FDA program that is giving top-tier, early career health care professionals, scientists, and engineers the chance to gain broad exposure to FDA regulatory science and scientific review opportunities. Led by OCS’s Office of Scientific Professional Development, the Commissioner’s Fellowship Program (CFP) is accepting applications from April 16 to May 26, 2014. Those who are accepted into the CFP will be joining FDA’s 7th class of Fellows.

Stephen OstroffDuring the two-year program, Fellows complete rigorous graduate-level coursework and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior-scientist preceptor.

In the CFP, a Fellow is able to gain real experience in an FDA biology, physics, or engineering lab, work with a clinical review team, or work at a regional field laboratory or office. The coursework provides a common core understanding of the science behind regulatory review, encompassing activities across all FDA-regulated product areas.

Specific Fellow projects may focus on FDA review of sponsor applications for new products, monitoring product quality and safety, or other scientific or engineering topics. Fellows work closely with FDA scientists to create better research and evaluation tools and approaches, like assays for chemical or pathogen detection, or methods to assess clinical or health care data. Other science and policy areas of focus may involve foods or medical products in disciplines ranging from laboratory sciences to engineering, law, and ethics.

FDA launched the Fellowship Program in 2008 to achieve three critical goals:

1)      Attract to FDA top-tier scientists who can help tackle targeted regulatory science areas;

2)      Provide regulatory science training to expand the pool of experts;

3)      Recruit top scientific talent — scientists who may not have considered FDA in planning their career.

Since the program started, FDA has graduated 164 Commissioner’s Fellows, 75% of whom continued to work at FDA after completing the program. Our graduates have produced 175 publications based on their Fellowship work, represented FDA with 211 regulatory science presentations, authored or co-authored 917 reviews – ranging from original applications to supplements – and 26 Fellows have been the proud recipients of FDA Honor Awards.

The Fellows have brought an infusion of innovative ideas, new talents, and skills to FDA to help build the strong scientific foundation we need in our research and review activities. In turn, the CFP has enabled Fellows to develop their regulatory expertise and work confidently in the FDA environment.

Those Fellows who pursue careers outside FDA bring a deeper understanding of regulatory science and of FDA to their organizations. They enrich the regulatory science enterprise, whether by improving the quality of applications to FDA or by applying the knowledge and tools they’ve acquired through the CFP to develop practical solutions to an important public health challenge.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

For more information on eligibility criteria for the FDA Commissioner’s Fellowship Program and to apply for the upcoming class, please visit this Web link:

FDA Commissioner’s Fellowship Program Application Checklist

Getting it Right on Spent Grains

By: Michael R. Taylor

Since the March 31 close of the comment period on FDA’s proposed animal feed rule, we’ve received a lot of questions and comments about so-called spent grains. Spent grains are by-products of alcoholic beverage brewing and distilling that are very commonly used as animal feed.

Michael TaylorTo add to the picture, spent brewer and distiller grains are just a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. One industry estimate is that 70 percent of human food by-product becomes food for animals.

We’ve heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we’re not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.

We also believe the potential for any animal safety hazard to result from this practice is minimal, provided the food manufacturer takes common sense steps to minimize the possibility of glass, motor oil or other similar hazards being inadvertently introduced, such as if scraps for animal feed were held in the same dumpster used for floor sweepings and industrial waste.

We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.

We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.

Our door at FDA has been wide open to stakeholders at every step of the FSMA process. We have learned a lot through active, two-way dialogue with those who have concerns about what we propose or ideas about how we can achieve our food safety goals in the most practical way. We hope and fully expect that dialogue to continue.

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

Homing in Faster on Potentially Deadly Bacteria in Food

By: Nilda E. Villegas

Whether an outbreak of foodborne illnesses is caused by Listeria in cantaloupe, E.coli in salad or Salmonella in peanut butter, the faster the disease-causing bacteria are identified, the more illnesses can be averted.

Nilda VillegasLast year scientists based in FDA’s San Juan Laboratory were endowed with seed funding through a Health and Human Services HHSignite award to adapt traditional chemistry methods for the detection of foodborne pathogens. HHSignite (beta) is an internal competitive seed-funding opportunity to test new and unconventional ideas within HHS.

The team is being led by LCDR José Moreno of the U.S. Public Health Service, a microbiologist in FDA’s San Juan Laboratory. Working with Moreno on this project are Joseph Bloom, Ph.D., San Juan Laboratory science advisor, supervisory chemists Adalberto Cajigas and Héctor Espinet, science advisor Osvaldo Rosario, Ph.D., chemist Miguel A. Martínez, and staff fellow Fernando González, Ph.D.  FDA’s San Juan scientists were among 13 teams within HHS to receive such funding when Secretary Sebelius announced the finalists in June 2013.

San Juan Laboratory Team: Left to right in the back: Dr. Joseph Bloom, Dr. Osvaldo Rosario and Dr. Fernando González; standing in front Miguel A. Martínez and LCDR José Moreno.

San Juan Laboratory Team: Left to right in the back: Dr. Joseph Bloom, Dr. Osvaldo Rosario and Dr. Fernando González; standing in front Miguel A. Martínez and LCDR José Moreno.

Their proposal is to assess the utility and practicality of coupling CE-MS, which stands for Capillary Electrophoresis coupled with a Mass Spectrometer, that promises to be the workhorse of many analytical chemistry laboratories for use in identifying pathogenic microorganisms through the identification of specific proteins associated with pathogenicity by their fragmentation patterns. This essentially identifies specific “fingerprints” for disease-causing bacteria, such as E. coli, Salmonella, Listeria and Staphylococcus, in foods.

The research undertaken by Moreno and his team could result in faster screening methods for a wide array of pathogens as part of FDA’s food safety and food defense programs.

What’s next?

The San Juan team is continuing their research on this innovative screening tool to reduce testing times even more, and coordinating their efforts with their scientific colleagues in our Office of Regulatory Affairs and in our Center for Food Safety and Applied Nutrition on the mainland to protect the safety of the U.S. food supply.

Nilda E. Villegas is a Public Affairs Specialist in the San Juan District Office, part of FDA’s Office of Regulatory Affairs

FDA’s New Acting Chief Scientist Talks about His Office’s Vital Role

By: Stephen Ostroff, M.D.

This is a very exciting time to be stepping into the position of Acting Chief Scientist at FDA. A relative newcomer to the agency, I joined FDA’s Center for Food Safety and Applied Nutrition seven months ago as chief medical officer and senior public health advisor for the Office of Foods and Veterinary Medicine.

Stephen OstroffBut as the former deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention and director of the Bureau of Epidemiology at the Pennsylvania Department of Health, I often worked with colleagues at FDA and have a solid appreciation for FDA’s public health mission and the pivotal role science plays in everything FDA does. So, I’m very enthusiastic about continuing the development of FDA’s scientific enterprise and positioning the Office of the Chief Scientist (OCS) to best support the agency’s scientific programs.

I’d like to take the opportunity over a series of blogs to discuss the important role that OCS plays in keeping our foods safe and nutritious and in getting essential therapies to the people who need them.

FDA has grown from a lone chemist in the U.S. Department of Agriculture in 1862 to an agency with a staff of 14,600 employees. More than 65% of them are scientific and technical staff, representing disciplines such as biologists, nurses, pharmacists, physicians, veterinarians, behavioral scientists, statisticians, epidemiologists, economists and engineers.

FDA requires this breadth and depth of expertise to ensure that science informs the decisions we make about the safety and effectiveness of drugs, biologics, and medical devices, the safety of foods and cosmetics, and the regulation of tobacco products, particularly as those products become increasingly complex. Only then can the public be confident that these products are rigorously reviewed and assessed before and after they go to market.

Transformative changes in society and technology over the past several decades have created numerous opportunities to improve public health. They’ve also created challenges affecting FDA-regulated products and the way FDA conducts its operations.

For example, globalization is bringing an increasing volume of foods and drugs to our shores, often produced in countries that may not have our high standards of regulatory oversight. New areas of science and rapidly evolving technologies are showing real promise in our ability to prevent and cure some of today’s biggest killers, such as diabetes, cancer, and Alzheimer’s.

To meet these challenges, we are “advancing regulatory science.” In other words, we are developing the new tools, methods and approaches that will be needed for a globalized regulatory environment and for translating new discoveries into innovative medical treatments. But advancing regulatory science research and training requires multidisciplinary and interdisciplinary collaboration within FDA and with our partners in academia, industry, other government agencies and with patient advocates. OCS works to meet these goals by strengthening FDA’s scientific infrastructure, forging a common vision, and working with our stakeholders to identify critical regulatory science and innovation needs.

In my future blogs, I will discuss examples of the exceptional work underway in the different OCS components—the National Center for Toxicological Research (NCTR), the Office of Counterterrorism and Emerging Threats, the Office of Minority Health, the Office of Regulatory Science and Innovation, the Office of Scientific Integrity, the Office of Scientific Professional Development, and the Office of Women’s Health. I can think of no more exciting place to be than at the core of FDA’s pioneering regulatory science culture.

Stephen Ostroff, M.D., is FDA’s Acting Chief Scientist

Mexico and the U.S.: Progress on Food Safety Partnerships

By: Michael R. Taylor

En Español

Spring may be on the way, but it’s still winter weather in most areas of the country. If you are enjoying fresh avocados, berries or grapes, there is a good chance they came from Mexico. In fact, about two-thirds of the fresh produce imported into the United States comes from our neighbor to the south.

Food safety meeting attendees, Tubac, Arizona

Food Safety Meeting attendees, from left to right:
Samir Assar, Director, Produce Safety Staff
Bonnie Fernandez-Fenaroli, Executive Director, Center for Produce Safety – UC Davis
Lance Jungmeyer, President, Fresh Produce Association of the Americas
Hugo Fragoso Sanchez, General Director of Food Safety for Food, Agriculture and Fisheries, SENASICA
Walter Ram, Vice President of Food Safety, The Giumarra Companies
Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine

Ensuring the safety of imported produce is a major focus of FDA’s food safety strategy. That is why I am in Tubac, Arizona to meet with Mexican government officials and producers of fresh fruits and vegetables from both sides of the border. The meeting is sponsored by the Fresh Produce Association of the Americas and the Center for Produce Safety in Davis, California – two organizations that take food safety very seriously.

There’s no substitute for face-to-face meetings like this to move the needle forward on food safety. Under the Food Safety Modernization Act (FSMA), FDA is developing standards for produce safety that, when implemented, will raise the food safety bar for produce sold in the U.S., whether grown here or in other countries. However, we also have to focus on how the new standards can be effectively and efficiently implemented. How will government and industry – both in the U.S. and abroad – operate under the new requirements? How can we take best advantage of our collective efforts to understand and prevent foodborne hazards and verify that applicable standards have been met? That, after all, is where the rubber meets the road.

We don’t have all the answers yet, but we do know we can’t do it alone. I’m joined in Tubac by Samir Assar, who heads FDA’s Produce Safety Team, Dominic Veneziano, who directs our import operations; and Bruce Ross, deputy director of FDA’s Latin America office. And we are sharing the podium with Hugo Fragoso Sanchez from SENASICA and Mario Alanis Garza from COFEPRIS – the two Mexican agencies with which we have long worked closely on food safety.

Historically, our government-to-government collaboration has come mostly in response to outbreaks, import alerts and other incidents. Now, we are focused on work we can do together to better understand potential foodborne hazards and take risk-based steps to prevent or minimize them. This means building partnerships to implement FSMA in the United States and at our common border, as well as collaborating with Mexico to support its food safety modernization initiatives.

Food safety partnerships – at the U.S.-Mexico border and across the food system – must, of course, extend well beyond government. The food safety practices of growers and processors, coupled with private sector supply-chain management, are what make food safe. Government establishes the common base of standards and provides a measure of public accountability for food safety, but verification that standards are being met is a joint public-private effort.

So, we are taking advantage of the Tubac meeting to talk to members of the produce industry about how public and private verification efforts can mesh. Our goal is simple: We want to provide the high levels of assurance about the safety of produce and other food that FSMA calls for and consumers expect. And, in a world of finite resources, we can do that only by relying, where possible, on others to complement our own efforts, and by avoiding duplication.

The next step in building our partnership with Mexico is a three-day meeting in late March with our SENASICA and COFEPRIS colleagues that we will be hosting at our Silver Spring, MD, headquarters. That discussion will build on past collaborative efforts on training, laboratory coordination, risk assessment and outbreak response, but it will be looking ahead to how we can build partnerships for the prevention of food safety problems. After the meeting, we will also be engaging our private stakeholders – industry, consumers, and academia – in this dialogue.

“Partnership” is an easy word to say, but making it real is hard work. We have to learn, continuously, about and from each other; and we have to deal with hard issues in order to expand and align our capacities, share data and information across both public and public-private lines, and build the trust that is the basis for mutual reliance. Some of this will be hard, but we wouldn’t be in Tubac if we didn’t think it were possible – and if we didn’t know active partnership is essential to achieving the food safety goals we all share.

We’ll keep you posted on our progress.

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

Planning Healthy Changes to the Nutrition Facts Label

By: Margaret A. Hamburg, M.D.

When the Nutrition Facts Label was created in 1993, it was revolutionary. For the first time, consumers could read the nutrition information on a food package to know what was in it and that the information was held to government standards for consistency and accuracy. This rectangular box has since become one of the world’s most recognized graphics, with countries around the world adopting their own version.

Margaret Hamburg, M.D.To continue the spirit and purpose of the Nutrition Facts Label, we are proposing important changes to bring it fully into the 21st century. A lot has changed in the past 20 years. Much more is known about food consumption and nutrition, the health of our population and the dietary choices that can help keep us healthy or make us vulnerable to an array of chronic diseases.

The changes that we’re proposing reflect that knowledge, based on an extensive examination of the latest public health trends and research on nutrition and disease, including obesity. There is a lot of information on FDA.gov about our plans, but I’d like to hit the highlights:

  • “Added sugars” would be listed on the label along with the current “Sugars” declaration (which includes both naturally occurring and added sugar). This alone is huge: The average American takes in many calories every day in sugars added during food production. Experts call these “empty calories” that often take the place of foods rich in nutrients.
  • Speaking of nutrients, listing the amount of Vitamin D and potassium – which many of us don’t get enough of – would be required. They would join calcium and iron as nutrients important to public health.
  • People generally eat differently today than they did 20 years ago. The serving size requirements would be updated to more accurately reflect what we’re actually eating. By law, serving sizes must be based on what people actually eat, not on what people “should” be eating.
  • Certain packages that are typically eaten in one sitting would be required to be labeled as a single serving, which would mean you would know how many calories and nutrients you are consuming for the whole package. For example, a 20-ounce soft drink would be one serving under the proposal, not more. Certain larger packages that could be consumed in one sitting or in multiple sittings would be required to be labeled per serving and per package.
  • While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.
  • The format would be modernized. Calories and serving sizes would be displayed more prominently in larger, bold type. The %DV (daily value) would be moved to the left, so that you can immediately put a nutrient in the context of your daily dietary needs.

I’ve been asked if we’re proposing these changes because an increasing number of people in this country, including children, are obese and at risk of serious diseases tied to food consumption.

The answer is both no – and yes.

No, because the Nutrition Facts Label is for everyone. FDA does not regulate diets, but we can make sure that you know exactly what you’re eating. Having more information can enable you to make an educated decision about the foods you eat and serve your family.

Yes, because we know that too many people’s health is being compromised by the food they eat. This includes those at risk for serious disease like cardiovascular disease, hypertension, strokes, diabetes, and obesity and all of us to wanting to have healthy diets can tell at a glance what is in a particular food.

As a consumer myself, I would find a Nutrition Facts Label that reflects the current science very helpful when making food choices for myself and my family. These changes should make it easier than ever to judge a food by its label.

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