OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

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

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.

Taha Kass-HoutThese publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source.

Consider the 3 million plus reports of drug adverse reactions or medication errors submitted to FAERS, the FDA Adverse Event Reporting System (previously AERS), since 2004.

Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set – and others – to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives.

But obtaining this information hasn’t always been easy.

In the past, these vast datasets could be difficult for industry to access and to use.  Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.

openFDA logoOpenFDA will make our publicly available data accessible in a structured, computer-readable format. It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.

Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.

Using this data, a mobile developer could create a search app for a smart phone, for example, which a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.

As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information.

OpenFDA uses cutting-edge technologies deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently. As we move forward with the early stages of openFDA, we will be listening closely to the public, researchers, industry and all other users for their feedback on how to make openFDA even more useful in promoting and protecting 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.

FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P.

“Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones.

8547850411_6e188c4b11_o-1As we celebrate National Women’s Health Week (May 11-17), I want to highlight some of the many ways in which FDA is working to make sure that women have the resources they need to make informed health choices.

FDA’s Office of Women’s Health (OWH) offers educational resources to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We develop and disseminate easy-to-read health materials and educational videos for women. We also connect women to these resources and other safety information on the FDA’s For Women website.

Throughout this week, OWH will be conducting special health promotions to connect women to resources on how to stay healthy. Starting today, women can order a free kit of OWH health materials on topics including mammograms, sleep problems, pregnancy, and contact-lens care. OWH is also collaborating with FDA’s Office of Communications to share tips for new mothers and other resources.

Lastly, we’re using social media to challenge women to take better care of their health. Encourage the women in your networks to follow us on Pinterest for a special challenge and health tips each day of the week. Use #1wk4health to participate.  In addition, follow @fdawomen and join us on May 13 at 1 pm for a Twitter chat we are co-hosting with the National Institute of Health’s National Heart, Lung, and Blood Institute and Office of Research on Women’s Health; the Department of Health and Human Services’ Office of Minority Health; and Everyday Health.

Once the week is over, I hope you will continue to look to FDA for women’s health resources. Encourage the women in your community to read our health materials, watch a video or participate in one of our social media activities.

Marsha B. Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health

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