Teachers Learn About the Science Behind Food Safety and Nutrition

By: Sharmi Das

This past July, middle and high school teachers got a taste of the latest food safety and nutrition information at the FDA’s 15th annual summer training program for school teachers. The week-long program aims to improve food safety and nutrition education in U.S. schools so students are better armed to make nutritious food choices and understand the proper handling of food.

Sharmi DasThe program, called Science and Our Food Supply, uses a curriculum co-developed by FDA and the National Science Teachers Association (NSTA). To date, 652 teachers (from all 50 states, the District of Columbia, and some U.S. Territories) have completed the weeklong training. This year, 32 teachers from 22 states participated in the program and will return to their own schools to teach the curriculum this school year. This class included teachers who specialize in biology, chemistry, food science, health, and family and consumer sciences such as culinary arts.

The creation of a strong network of teachers and students around the country who are “food savvy” is a measure of the program’s success. The program’s participants will reach an estimated 3,200 new students, as well as 640 additional teachers in daylong train-the-teacher sessions, this coming school year. These estimates conservatively reflect the reach of this program – many teachers report using this curriculum to educate consumer groups within their communities, as well as sharing their new knowledge with their own friends and family.

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

During the weeklong program, teachers learned about the journey food takes from farm to table. The training included basic microbiology techniques in a University of Maryland teaching lab, along with introductions to the latest food safety and nutrition research from scientists at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and USDA’s Beltsville Agricultural Research Center (BARC). The teachers heard about new and ongoing research on food safety, nutrition and nutrition labeling, food allergies and food allergen labeling, and cosmetics safety.

In these settings, the teachers not only listened to presentations about relevant topics, but were given ample time to interact with the speakers. Teachers were excited at the opportunity to “ask the experts” many of the questions their students had brought up in class. Lively discussions on the topics of food allergies, color additives, and cosmetics helped teachers understand FDA’s role in regulating several products.

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

Train the trainer…. Teachers learning about nutrition and food safety through the Science and Our Food Supply program at FDA/CFSAN

At the end of the week, teachers reported on the many ways the training and curriculum will be used to teach their students about food safety and nutrition. “I feel like I can better explain and allow them to investigate better/healthier food choices,” said Victoria Obenchain, of Moraga, Calif. The teachers were also given a variety of educational materials and resources to help them use the curriculum in their own schools.

The FDA-NSTA training program immerses educators in the world and culture of food safety and nutrition for a full week. This experience provides school teachers with a comprehensive farm-to-table perspective on food safety and nutrition, allows them to become familiar with the many and varied backgrounds of professionals in this field, and helps to educate thousands of students about Science and Our Food Supply.

Sharmi Das is the Director of the Division of Education, Outreach and Information in the Office of Analytics and Outreach in FDA’s Center for Food Safety and Applied Nutrition

50 States, One Goal: Working Together to Keep Our Food Safe

By: Melinda K. Plaisier and Michael R. Taylor

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

Melinda K. Plaisier

The August 12 conference in St. Louis of the Partnership for Food Protection (PFP) was truly a meeting of the minds. This 50-state workshop drew food and feed safety experts from federal, state, local, tribal and territorial government agencies. These organizations make up the PFP. Our shared goal? To continue working towards a food safety system in our country that makes our food as safe as possible.

Partnerships have become increasingly important in our efforts. Simply put, we can’t do it alone. The scope of the public health mission is too vast. We need to take advantage of the unique contributions state and local partners can make through their food safety commitment, knowledge of local conditions and practices, and local presence to deliver training, technical assistance and compliance oversight. Together, we can ensure an effective public health safety net.

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

Michael R. Taylor

But building the kind of partnership we envision is an extraordinarily complex task. There are 3,000 food safety agencies in this country at the federal, state and local level. The challenge we face is this: How do we make PFP a reality that will work for decades to come? Working together to corral the complexities of our global food supply is critically important to our success and represents a significant shift in the way we work.

And creating that new reality is what our recent meeting was all about.

FDA itself is in a time of transition through Commissioner Hamburg’s initiative of program alignment. The agency is working to better align internal operations, increasing specialization among inspectors, compliance officers, laboratory staff and others to give them increased technical knowledge in a specific commodity area, and partnering them with subject matter experts in FDA’s centers. Ultimately, this will streamline decision-making and provide real-time technical and policy support for frontline staff.

This effort will better position FDA to meet the challenges we face, including the continued evolution of science and technology, the reality of globalization, and implementing the rules we are working to finalize that will help make the FDA Food Safety Modernization Act (FSMA) a reality—each rule,  in its own way, transformative.

Speaking with one voice as an agency and acting in unison across internal boundaries will enable FDA to better support our state partners as we all work to use innovative tools, training and approaches.

Our collaborations with the Association of Food and Drug Officials, the National Association of State Departments of Agriculture, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials, the National Environmental Health Association, and the Association of Public Health Laboratories—just to name a few—are equally valuable in this cause.

We are well on our way toward making our partnership through PFP a foundation of the modern infrastructure we are building to protect public health. Our partners are engaged, and FDA is all in. And now we are truly beginning to see some of the fruits of our labor. Until we meet again, our work continues.

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

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

FDA Researchers Build Partnerships to Advance Innovations

By: David G. White, Ph.D.

Last week, FDA scientists and researchers presented more than 160 abstracts at the 4th Annual Food and Drug Administration Foods and Veterinary Medicine Science and Research Conference:  that’s more than 160 research projects focused on protecting the health of people and animals. The presentations and posters at the conference were shared among approximately 300 FDA researchers and other staff members who came to hear the latest on our science and research accomplishments.

David White and Heather Tate discuss poster

Heather Tate, author of “NARMS investigation of an increase in Salmonella serotype IIIa 18:z4,z23:- isolated from retail meats and humans,” discussing her poster with David G. White, Ph.D., Chief Science Officer and Research Director, FDA Office of Foods and Veterinary Medicine, at the 4th Annual FDA Foods and Veterinary Medicine Science and Research Conference. See more photos of this event on Flickr.

FDA research in the food and veterinary medicine arena covers many different fields of study, from foodborne pathogens to nanotechnology, food allergens, dietary supplements and much more. For example, research is being conducted to improve detection methods for numerous microbial pathogens and chemical hazards that may contaminate the foods you and your pets eat. The diverse research portfolio of this conference showcased all the advancements in science and technology that the FDA is investing in to protect the health of people and animals.

The research presented was the highlight of the conference, but we are making equally important advancements as an organization. We have come very far in terms of our communication and collaboration among foods, cosmetics, and animal health researchers across different components of the FDA. There are so many parts of FDA involved in these areas of research that our top priority is to be sure we are working together and using our resources strategically. We must make sure our projects are more than just interesting – they must be focused on our highest public health priorities.

One of the major themes of the conference was that partnerships are critical to fostering innovation. This was emphasized by Deputy Commissioner for Foods and Veterinary Medicine Mike Taylor, who noted in his opening remarks the terrific effort of everyone who worked on the Whole Genome Sequencing project – a major undertaking that was recently a finalist and a Secretary’s Pick for the Department of Health and Human Services (HHS) Innovates award.

FDA Science and Research Conference

Tammy Barnaba, author of “Surveillance of Probiotic Ingredients in Dietary Supplements and Microbial Variations Between Product Lots,” explaining data from her poster to Laurenda Carter, another attendee, at the 4th Annual FDA Foods and Veterinary Medicine Science and Research Conference. See more photos of this event on Flickr.

This project was launched to showcase the capacity of this technology to revolutionize foodborne disease tracking, and it was a true collaboration among many laboratories within FDA (Center for Food Safety and Applied Nutrition and Office of Regulatory Affairs), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS).

One of the goals of our Whole Genome Sequencing initiative is to further develop and roll out a pathogen detection network called the GenomeTrakr, which would store genomic data of common foodborne pathogens such as Salmonella and Listeria. This data would enable FDA scientists to determine the exact order of the molecules in an organism’s genetic material, information which can then be used to identify specific strains of bacteria or viruses in foods that are causing illness. Once the strains are identified, scientists from FDA, CDC, USDA and the various states can quickly and efficiently trace the strain back to the origin of contamination so that we can improve the safety of our food supply and protect people from becoming ill.

As Dr. Eric Brown, the director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Division of Microbiology in the Office of Regulatory Science, explains: “What genome sequencing allows us to do with food traceback is unprecedented. It’s like upgrading from an old backyard telescope to the Hubble.”

The projects presented at this year’s conference highlight the progress we have made, and the progress we want to continue to make, to expand our partnerships beyond FDA and our sister agencies, such as CDC and USDA, into academia and the private sector.

It’s exciting to see the headway we are making and the commitment of our researchers to protect and promote the health of humans and animals.

David G. White, Ph.D., is Chief Science Officer and Research Director, FDA Office of Foods and Veterinary Medicine

See more photos of this event on Flickr.

A New Era of “Gluten-free” Labeling

By: Michael R. Taylor

For most of us, choosing a meal is not a make or break decision. Most people prepare a meal without fearing that it will endanger their health. That’s not the case with people who suffer from celiac disease. I’ve learned first-hand from talking with people with the disease how much it means to them to be able to select gluten-free foods with confidence.

Michael TaylorCeliac disease is a serious health issue and there is no cure. The only choice for the more than 3 million Americans living with the disease is adherence to a diet free of gluten — proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals, and possibly leading to a host of other health problems.

Last year FDA issued a rule on food labeling to improve life for people with celiac disease. The rule ensures that “gluten-free” claims on food packages are reliable and consistent. It provides a clear definition of the term so that all packaged food products bearing the claim “gluten-free” contain less than 20 parts per million of the protein.

And today is the compliance date for this rule. This is important because it means that any packaged food product labeled with the “gluten-free” claim, as of today, must meet the standard set by the FDA.

FDA gave companies a year to make the necessary changes to their products if they used the “gluten-free” claim. This past year, we took steps to educate industry about the rule and what it means to be gluten-free. In June, we issued a guide to help small businesses comply with the rule.

The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, FDA says that restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition. I’m pleased to note that the National Restaurant Association also advised operators offering “gluten-free” items on their menus to make sure their claims are consistent with the definition.

Honest and accurate “gluten-free” labeling will strengthen consumers’ confidence in the products that carry it. One of the rule’s requirements is that it establishes a threshold of 20 parts per million — meaning that to be labeled as free of gluten, each kilogram of the product must contain less than 20 milligrams of the protein. This is consistent with the threshold established by other countries and international bodies that set food safety standards.

I commend companies that have already stepped up to the plate to meet the definition for “gluten-free” labeling. They make it possible for consumers to have labels they can trust as they make well-informed food choices.

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

Achieving our Mission through Enhanced IT Service Delivery

By: Walter S. Harris, M.B.A, P.M.P.

At its core, FDA is an information- and process-driven organization. Day-in and day-out, FDA’s experts make thousands of weighty and complex decisions by evaluating, and allowing access to, life-sustaining, life-enhancing and life-saving products. This is done using a vast amount of sophisticated and reliable data. And it is done while continuously engaging with consumers, patient representatives, industry, academia and other government agencies.

Walter HarrisSince the establishment of the Office of Information Management and Technology (OIMT) seven months ago, we have fundamentally changed how we support the Agency’s mission — primarily, to increase transparency, and better align functions and resources to achieve more efficient and improved customer support and services. To further these objectives, we have taken the following steps to help transform our service to our internal and external stakeholders.

  • Reorganized the Office of Information Management into a more stable structure that is focused on our customers and the delivery of services. This new IT structure includes robust leadership, increased scientific capability and closer attention to IT’s business and customer needs, including a new IT audit and compliance program.
  • Hired the first Chief Health Informatics Officer (CHIO), Taha Kass-Hout, MD, M.S., to promote and develop innovative enterprise solutions and identify opportunities for transparency and availability of FDA’s public health data to our consumers while ensuring accountability and privacy. With the launch of openFDA, we have demonstrated our ability to respond quickly and accurately to emerging scientific, technological and economic trends.
  • Requested that the CIO Council, FDA’s IT governance board with representation across all of its Centers, focus on opportunities to consolidate IT solutions into capabilities that benefit the agency, eliminating duplication of efforts and creating possibilities for reinvestment.
  • Creating an IT service cost-allocation model that will include a service catalog and identification of cost drivers for IT services.
  • Restructuring our IT portfolio to a service based portfolio model that is in alignment with our cost allocation model.

OIMT, together with IT leaders in the Centers, will transform our IT operation to minimize redundancies, streamline IT, and enhance customer service while lowering IT costs to the agency. We continue to seek opportunities to  identify and tackle issues, improve communications across functional lines, and more fully capitalize on the expertise of our talented staff.

These are exciting endeavors and I am proud of the efforts IT leaders across the FDA have taken to focus on customer service. With a renewed emphasis on service delivery to enable mission outcomes, we are better able to use resources in a manner that will achieve greater efficiency, improve support across the FDA, and provide results that benefit the public health.

Walter S. Harris, M.B.A, P.M.P., is FDA’s Deputy Commissioner for Operations

A Milestone in our Partnership with Mexico on Food Safety

En Español

By: Michael R. Taylor

We know that food safety is more a journey than a destination, but there are times when we can point to a major milestone along the road. Today, we reached such a milestone in our long-standing relationship with Mexico by signing a statement of intent to establish a new produce safety partnership.

signing ceremony in Mexico

Left to right: Michael R. Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine; Enrique Sánchez Cruz, Executive Director, SENASICA, Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration, and Mikel Arriola Peñalosa, Commissioner, COFEPRIS – at today’s signing ceremony.

Working with Mexico on food safety is a top priority. Mexico is one of the United States’ top trading partners, and much of the produce we eat is grown there, including produce that otherwise would be hard to find during the winter. And food safety modernization efforts are underway in both countries, providing an excellent opportunity for progress. In the U.S., we are implementing the Food Safety Modernization Act, and produce safety is a big part of that effort, while Mexico is implementing an amendment to its food safety laws that mandates standards for fresh produce, inspections, and surveillance and verification programs.

We have been working with the two food safety agencies in Mexico—SENASICA, the National Service for Agro-Alimentary Public Health, Safety and Quality, and COFEPRIS, the Federal Commission for the Protection from Sanitary Risks—for some time, and it has been a very rewarding relationship. Last fall, I had the pleasure of traveling to Mexico City to meet with Dr. Enrique Sanchez Cruz, director general of SENASICA, and Mikel Arriola, federal commissioner of COFEPRIS, who were both present for today’s signing ceremony. And in March of this year, I traveled to Tubac, Arizona, to meet with Mexican government officials and producers of fresh fruits and vegetables from both sides of the border to discuss how all of us—in both the public and private sectors—can do our part to meet high consumer expectations for food safety.

The statement of intent is just a two-page document, but it represents a strategy that is far-reaching and designed to achieve high rates of compliance with produce standards in each country. In the months and years to come, we will be working with Mexico to identify practices to prevent contamination during the growing, harvesting, packing, holding and transportation of fresh fruits and vegetables and verification measures to ensure these preventive practices are working. We will exchange information to better understand each other’s produce safety systems—and in fact, this sharing is already underway. We intend to develop culturally appropriate education and outreach materials to support industry compliance with produce safety standards, and we will work on enhancing our collaboration on laboratory activities and on outbreak response and traceback activities.  It’s an ambitious agenda, and that is the value of an inclusive partnership. We are engaging industry, commerce, agriculture, academia and consumers because everyone has a role in ensuring the safety of the food supply.

It is gratifying to see the progress we have made along the way—and even more gratifying to know that with the new produce safety partnership in place, fruits and vegetables will be safer for consumers on both sides of the border.

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

On the road from Mexico: a model for regulatory cooperation

En Español

By: Margaret A. Hamburg, M.D.

Margaret Hamburg

FDA Commissioner Margaret A. Hamburg, M.D., meeting with Mexican public health and regulatory officials in Mexico City this week

This week I’m making my first visit to Mexico as FDA Commissioner and, while I am savoring the rich culture, warm people and delicious food, the trip is providing me with a vital first-hand perspective of the long-standing, productive and collaborative working relationship FDA maintains with our regulatory counterparts in this wonderful country. I’ve blogged many times about the importance of adapting to our rapidly changing world—one in which the medical products we use and the foods we eat are increasingly produced in countries other than our own. Perhaps nowhere is that dynamic more vivid than with our neighbors to the South. And nowhere provides a more profound example of how cooperation is essential to protect public health and realize the benefits of a vibrant trade relationship.

Today, Mexico is a major player in the global marketplace and, of course, one of the United States’ most important trade partners. In the U.S., nearly one-third of the FDA-regulated food products we eat come from Mexico. On the medical products side, Mexico is the 2nd leading exporter of medical devices to the U.S.—the vast majority of which are lower risk devices such as surgical drapes, wheelchair components, and non-invasive tubing.

The foundation of successful cooperation is forging real relationships with our regulatory counterparts and our key stakeholders including the industries we regulate. FDA’s office in Mexico City—one of three in the Latin America region—has been a critical source of support for many of our collaborative activities since we opened its doors some four years ago. And this week my colleagues and I have had the opportunity to have fruitful meetings with the leaders of the Mexican Ministry of Health and the two regulatory agencies with whom work so closely: COFEPRIS (the Federal Commission for the Protection from Sanitary Risks) and SENASICA (the National Service for Agroalimentary Public Health, Safety and Quality).

We’ve discussed our respective strategies to address our nations’ most critical public health issues like obesity and nutrition, and the important ways in which we share information and align our regulatory approaches. For example, our partners in Mexico have such confidence in FDA’s premarket review system of medical products that COFEPRIS issues agreements with companies — agreements that recognize FDA approvals and grant drug and device companies “fast track” pathway to make their products available to patients dramatically more quickly.

Margaret Hamburg and Mike Taylor at mushroom farm

FDA Commissioner Margaret A. Hamburg, M.D. (foreground), and Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine (left), visit a mushroom farm in Mexico

We also held two interactive roundtable discussions with members of the medical products and food industries in which we had lively exchanges about key issues such as how quality manufacturing is not only good for public health, but good for business. And yesterday I got a close up view on that critical concept with a visit to the Monteblanco facility of Hongos de Mexico, S.A. de C.V., one of Mexico’s largest producer of mushrooms – located in the Toluca valley just a 90 minute drive from downtown Mexico City. Hongos de Mexico is a company that FDA has routinely visited and inspected given Monteblanco produces a staggering 60,000 pounds of mushrooms each day for consumption within Mexico and export to the U.S. and other countries. In addition to being an enlightening education on the process of growing and packing mushrooms, our visit to the Monteblanco facility was a living example of the critical role the private sector plays to ensure the safety of products for consumers in the U.S. and around the world.

Today is the final day of our jam-packed visit to Mexico and I’m thrilled that we will be signing a Produce Safety Partnership Statement of Intent, which is just the latest example of the successful collaboration to reduce the increased risk of foodborne illnesses that naturally comes with a more globalized market. The partnership will support our work to implement preventive practices and verification measures to ensure the safety of fresh and minimally produced fruits and vegetables.

At the end of the day, our trip to Mexico has shined a bright light on how important it is to continue to explore new ways to fulfill the mission that we share with our regulators around the world—to protect and promote public health. Our partnership with Mexico serves as a model not only as it relates to improving the health and well-being of consumers but also to promote innovation and economic growth.

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

OpenFDA Provides Ready Access to Recall Data

By: Taha A. Kass-Hout, M.D., M.S.

Every year, hundreds of human and animal foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be ordered by the U.S. Food and Drug Administration. Recalls are reported to the FDA, and compiled into its Recall Enterprise System, or RES. Every week, the FDA releases an enforcement report that catalogues these recalls. And now, for the first time, there is an Application Programming Interface (API) that offers developers and researchers direct access to all of the drug, device, and food enforcement reports, dating back to 2004.

Taha Kass-HoutThe recalls in this dataset provide an illuminating window into both the safety of individual products and the safety of the marketplace at large. Recent reports have included such recalls as certain food products (for not containing the vitamins listed on the label), a soba noodle salad (for containing unlisted soy ingredients), and a pain reliever  (for not following laboratory testing requirements).

At present, FDA provides various ways to access the recalls data, including an RSS feed, a Flickr stream, and a search interface. This new API supplements these sources as the first, and one-call, access to the entire enforcements archive. The hope is that this API will be useful to developers and researchers interested in FDA enforcement actions. Developers can now call into the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories, or specific foods or drugs.

The recalls database is the second dataset to be released on openFDA. Since openFDA debuted on June 2, 2014, the website has generated considerable interest. In the past five weeks, the site has had 34,000 sessions (two-thirds are new sessions) from 26,000 unique visitors worldwide that generated 80,000 page views.

The adverse events API has been accessed by 18,000 Internet connected devices, with nearly 2.4 million API calls since the launch.  At least one new website, http://www.researchae.com, has been created to allow any user to submit queries on the adverse events data, and several other companies are integrating the data into their products and services. It is also being accessed by researchers inside and outside FDA and by journalists as well.

More APIs will follow in the weeks ahead. OpenFDA is taking an agile (development in small chunks of iterations) approach in the creation and release of these APIs, with the objective of getting feedback from developers and researchers (as well as from industry and the public) at the GitHub and StackExchange forums that serve our project. We plan to incorporate some of the feedback into future iterations of the API. Accordingly, as we learn more about how the public might seek to use this data — and as a result of our agile and user-centered methodologies — the API structure may change in quite a bit in the coming months. It’s also important to note that this API, like all others on openFDA, are in beta and are not ready for clinical use. However, their contribution to FDA’s public health mission already now grows every day.

Taha A. Kass-Hout, M.D., M.S., is FDA Chief Health Informatics Officer and Director of FDA Office of Informatics and Technology Innovation

FDA Leverages Big Data Via Cloud Computing

By: Taha A. Kass-Hout, M.D., M.S.

Last year, I worked with a group of colleagues throughout the Food and Drug Administration (FDA) on a project that is critical for the agency’s future: the modernization of our information technology platforms to prepare for the influx of “Big Data”—the enormous data sets we receive daily from manufacturers, health care providers, regulatory bodies, scientists and others.

Taha Kass-HoutThese data sets are not only larger than ever before, they are also arriving more frequently than ever and varying enormously in format, and quality.

This year alone, we expect to receive somewhere between 1.5 and 2 million submissions through our eSubmission Gateway – and some submissions can now be as large as a Terabyte (one trillion bytes) in size. This is the very definition of a big data.

But, at FDA, we view it as an opportunity and a challenge. To meet both, we are building an innovative technology environment that can handle vast amounts of data and provide powerful tools to identify and extract the information we need to collect, store and analyze.

A key example is our recent leveraging of cloud computing.

“Cloud computing” is, basically, computing on demand. Think of how you use water, or electricity, at the same time as do your neighbors and millions of others. You pay only for what you use, and service is always guaranteed. You don’t need to wait till your neighbor is done to use the washer or dryer because there is only enough electrical capacity to handle one person at a time.

The same is true of cloud computing, which stores data on the Internet, rather than on the hard drive or drives of computers. In essence, it gives us the ongoing, simultaneous capacity to collect, control and analyze enormous data sets.

For example, FDA, partnering with state and local health organizations, identifies thousands of foodborne pathogen contaminants every year. We sequence, store and analyze this data to understand, locate, and contain life-threatening outbreaks. Again, cloud computing aids us in this effort.

Finally, FDA has some of the world’s most valuable data stores about human health and medicine. Through OpenFDA, our newest IT program, we are making some of these existing publicly available data sets more easily accessible to the public and to our regulatory stakeholders in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis. OpenFDA is beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013 and will later be expanded to include the agency’s databases on product recalls and product labeling.

OpenFDA promotes data sharing, data access, and transparency in our regulatory and safety processes, and spurs innovative ideas for mining the data and promoting the public health.

Big data is important to the way we carry out regulatory science, which is the science of developing new tools and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. Through innovative methods such as cloud computing, we are taking advantage of this flood tide of new information to continue to protect and promote the public health.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Informatics and Technology Innovation.

Why We Want Pregnant Women and Children to Eat More Fish

By: Stephen Ostroff, M.D.

Ten years ago, the Food and Drug Administration and the Environmental Protection Agency advised pregnant and breastfeeding women, and women who might become pregnant, to limit their consumption of fish to no more than 12 ounces a week to protect the fetus and their children from mercury, which is present to some degree in all fish.

Stephen OstroffIt appears many women may have taken that advice too far. FDA’s analysis of the reported seafood consumption of more than 1,000 pregnant women in the United States found that over 20 percent of them had eaten no fish at all in the previous month. Of the women who reported eating fish, 50 percent ate less than two ounces a week, and 75 percent ate less than four ounces per week.

That’s a real problem because we now know that that there’s a beneficial link between eating fish during pregnancy and children’s growth and development. Scientific studies indicate that the best way for pregnant and breastfeeding women to reap those health benefits for their children while minimizing risk from mercury is by eating at least eight to 12 ounces per week of a variety of fish lower in mercury. That is the level that we are now recommending.

What fish are lower in mercury? The answer is most fish in the grocery store. For example, nine of the most-commonly eaten fish in the U.S. are toward the low end: shrimp, pollock, salmon, canned light tuna, tilapia, catfish, cod, flatfish and haddock. So there should be little difficulty in selecting fish to meet the optimal weekly amount of fish consumption.

The four fish that FDA and EPA continue to recommend that women in the target group and young children avoid because they are the highest in mercury are: tilefish from the Gulf of Mexico, shark, swordfish and king mackerel. These four types of fish are not commonly eaten in the United States and represent less than two percent of the market share here.

We are also continuing to recommend that women in the target group eat no more than six ounces per week of albacore tuna. This advice should not adversely affect most women’s current consumption patterns because six ounces a week is nearly three times the amount that most women are now eating of any type of fish in a typical week.

We want to hear from you about this draft advice. The draft is now open for comments. We also plan to take the draft updated advice to FDA’s Advisory Committee on Risk Communication, which will hold a public meeting on it in the near the future.

And separately, we have received a citizen petition requesting, in part, that FDA require that its recommendations about seafood consumption be posted where seafood is sold. This petition is currently under consideration by FDA.

Finally, I want to emphasize that pregnant or breastfeeding women should continue to consume a well-balanced diet to help ensure the health of their children. No matter what the food, our priority is making sure you know the benefits and the risks so that you can make the best choice for yourself and your family.

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