Blue Bell and the Very Real Impact of the Food Safety Modernization Act

By: Michael R. Taylor

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.

Michael TaylorAbove all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.

But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.

Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve, and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally.

There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became the law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year.

For example, the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.

We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls –authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.

We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.

No law can guarantee zero risk, from contaminated ice cream or any other food that has come in contact with a dangerous bacteria or other harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.

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

FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind

By: Heidi C. Marchand, Pharm.D.

In the U.S., only about 1 in every 4 prescriptions is taken as directed by a health care provider – a problem that costs our nation more than 125,000 lives a year. Millions of Americans with heart disease – the nation’s No. 1 killer – are especially vulnerable.

Heidi MarchandTo stem that tide, FDA has teamed with the nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society.

FDA’s Office of Health and Constituent Affairs has signed a Memorandum of Understanding with the National Forum to promote and increase the use of health knowledge, skills and practices by the public in their daily lives. The five-year agreement is a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

Heart disease, which kills 1 in 4 Americans, can be managed. To prevent heart attacks, transient ischemic attacks and other cardiac events, doctors prescribe medications and lifestyle therapies (e.g. heart-healthy diets). Because medication is not readily adhered to – and neither are lifestyle treatments – millions of people suffer from preventable cardiac episodes. As a nation, lack of medication adherence (which can be as simple as not getting a prescription filled or refilled) costs more than $100 billion annually in excess hospitalizations.

To confront this problem, FDA is taking the lead in support of Million Hearts®, a national initiative of the Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. A key partner in that mission is the National Forum, whose members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy and community sectors.

Together we will:

  • Explore, demonstrate and evaluate innovative health promotion concepts.
  • Exchange information on nutrition, heart disease, and ways to increase the number of patients who take their medication and/or therapy.
  • Identify and systematize best practices in behavior modification education.
  • Develop concepts for community-based interventions.

Our goals are clear: create recommendations to improve compliance with prescribed medical therapies and implement the recommendations to improve the lives of patients living with heart disease.

FDA’s Dr. Helene Clayton-Jeter and Dr. Fortunato “Fred” Senatore are leading a diverse team in identifying strategies to help patients take their medicines as directed and follow the advice of their doctors.

Concurrently, the National Forum will recruit a Therapy Adherence Steering Committee, made up of experts and stakeholders from physician and nursing groups, pharmacy (retail/system), behavioral health, consumer/patient groups and others invested in complying with medical therapy.

We’ll then jointly develop action plans for high-probability, high-yield strategies to promote heart health by helping ensure that patients take their medicines and adopt healthier lifestyles. Our plan is to complete all steps in the next several years.

We cannot fix this problem overnight. But by addressing it strategically, we can move forward and improve the odds of preventing and surviving heart disease and stroke among Americans.

Heidi Marchand, PharmD, is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

The 2014 FDA Food Safety Challenge: And the Finalists Are…

By: Palmer Orlandi, Ph.D.

I am delighted to announce the finalists in FDA’s first Food Safety Challenge, a ground-breaking effort to better protect our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce.

Palmer OrlandiLast September, we invited scientists, academics, entrepreneurs, and innovators from all disciplines to compete by submitting concepts that could improve and accelerate the detection of these disease-causing bacteria in foods. We received 49 submissions.

The five finalists whose proposals will enter the next phase of the Food Safety Challenge are teams of researchers from these companies and universities:

  • Auburn University, Auburn, Ala.
  • Pronucleotein Inc., San Antonio, Texas
  • Purdue University, West Lafayette, Ind.
  • University of California, Davis, Calif.; Dr. Bart Weimer; and Mars, Inc.
  • University of Illinois, Urbana-Champaign, Ill.; and Purdue University

(Purdue is represented twice, teaming with University of Illinois colleagues in one proposal and going solo in another, with different researchers on each team.)

Each team has developed ingenious new technologies for detecting food pathogens that could be real game changers in our ongoing fight against foodborne illness. They will each receive $20,000 and advance to the next stage in the Challenge. The winner or winners (there can be more than one) will share the remainder of the $500,000 total prize.

But before I describe the next step, let me remind you why this Challenge is vital to FDA’s mission to promote and protect the public health.

  • The Centers for Disease Control and Prevention (CDC) estimates that foodborne illness sickens 1 in 6 Americans  annually, resulting in about 3,000 deaths.
  • The overall negative economic impact of foodborne illness in the United States may be as high as $77 billion per year.
  • Salmonella is the leading cause of death and of hospitalization related to foodborne illness.

We believe that by reaching out through this Challenge to entrepreneurs, academia, and the larger scientific, innovation and problems-solving communities, we can view our food safety problems through a different lens. It’s a way to consider approaches, and possible solutions, through the eyes of innovative thinkers, and to use technologies we may not have considered.

What Happens Next?

Now that our panel of expert judges from FDA, CDC, and the U.S. Department of Agriculture has narrowed the competitive field down, we enter the Field Accelerator phase of the Challenge. With the guidance of FDA food safety and pathogen-testing experts, finalists will

  • refine their submissions,
  • clarify their concepts,
  • maximize their impact on food safety,
  • check that they are in line with FDA’s needs and capabilities,
  • and ensure that the proposed ideas can be reasonably executed.

The finalists will participate in a “boot camp” with FDA experts on May 13, 2015 to help strengthen their concepts and applicability to FDA’s testing process. “Demo Day” will be held on July 7, 2015 in College Park, Md. The finalists will present their improved proposals to the judges and a live audience in FDA’s Center for Food Safety and Applied Nutrition headquarters.

I, for one, can’t wait to see the solutions the finalists will come up with. We believe that by thinking outside the box, we can find new ways to help assure the American public that the foods they eat and serve their families are safe.

Palmer Orlandi, Ph.D., is Acting Chief Science Officer and Research Director in the FDA’s Office of Foods and Veterinary Medicine.

FDA Science Forum to Focus on Emerging Technologies

Dr. Luciana Borio, FDA’s Acting Chief Scientist, invites you to the FDA 2015 Science Forum at our White Oak headquarters in Silver Spring, Maryland on May 27-28. We’ll be showcasing exciting, cutting-edge regulatory science research. For more information and how to register for the forum before the deadline of May 15, 2015, go to The FDA Science Forum.

Learning from the Oneida: Food and Fellowship at the Heart of a Community

By: Michael R. Taylor

All over the country, local food systems produce, market, and distribute foods that nourish their communities. In our travels over the past few years, seeking input on proposed rules to implement the FDA Food Safety Modernization Act (FSMA), we have seen first-hand just how important these grassroots systems are to the American way of life.

Oneida Food Distribution Warehouse in Oneida, Wisconsin

Warehouse Supervisor Leonard Stevens with Deputy FDA Commissioner Michael Taylor at the Oneida Food Distribution Warehouse in Oneida, Wis. The Oneida Food Distribution Program feeds low-income members of the community.

I saw another impressive example of a community-centered food system when my colleagues and I toured the Oneida Nation in Wisconsin last month and met with members of the tribe, who are justifiably proud of their farming traditions. We met the people behind the Oneida Community Integrated Food Systems (OCIFS), established in 1994, which provides education about food, nutrition and health, and integrates locally produced foods into the Oneida community and institutions.

It is an impressive system. It includes a 6,000 acre farm, where they raise Black Angus cattle and bison; a 40-acre apple orchard that offers 34 varieties of apples, as well as other fruits and vegetables; an 80-acre organic farm that has community gardens and a cannery, and offers workshops on cooking and gardening; a food distribution program that feeds low-income members of the community; and a market in which the Oneida sell what they have planted, produced and harvested.

The community produces more than food. It also encourages healthy-eating. There is a state-of-the-art health center that focuses on weight management and diabetes prevention, striving to empower members of the community to make positive life choices. The facility is evocative of the tribal culture and sophisticated in its delivery of health services. They have had incredible success in improving diabetes outcomes in terms of care and prevention.

We toured and met with tribal leaders. Then we had a frank discussion about the important relationship between the FDA and the more than 560 federally recognized American Indian and Alaska Native tribes and villages. The Oneida Nation is a sovereign state, as are the other tribes, and federal agencies have an obligation to consult them in certain matters of importance. From their standpoint, the sheer number of federal agencies they have to deal with—including FDA, the U.S. Department of Agriculture, the Environmental Protection Agency, and the U.S. Fish and Wildlife Service—can be a source of frustration and confusion.

From FDA’s perspective, the challenge of working effectively with hundreds of diverse, sovereign tribal governments mirrors the challenges we face across the breadth of FSMA implementation.

The Oneida Nation is emblematic of the diversity of our food system. This diversity is a great strength, but it’s also part of what makes implementing FSMA and achieving food safety a daunting task. It’s doable, however, because, whether they’re sending their products around the world or around the corner, all participants in today’s food system have the same stake in food safety. It is FDA’s mission to reach across this broad spectrum, create standards that are feasible for all food producers, and support their food safety efforts any way we can.

This demands collaboration and partnerships. Our partnership with American Indian and Alaska Native tribes is among the building blocks of the modern food safety system mandated by FSMA. I was inspired by what I saw in our trip to the Oneida Nation, by their cultural commitment to the health of their community and their willingness to embrace new technologies while staying true to traditions. They lend rich color to the kaleidoscope that is our global food system.

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

FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.

FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

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

FDA’s Keynote Address to the Annual Conference of the Food and Drug Law Institute

By Stephen Ostroff, M.D.

Today marks the start of my third week as Acting Commissioner of FDA and I “celebrated” by giving a keynote address to attendees at the annual conference of the Food and Drug Law Institute (FDLI). Few places offer a more appropriate stage for a newly designated leader of FDA. As our names suggest, our organizations have a lot in common.

Stephen OstroffFor decades, the FDA and FDLI have worked together to educate and inform the broad “food and drug” community about the latest developments in our field and FDA’s critical and complex role in promoting and protecting the public health.

It’s been an exciting, busy, and rewarding first three weeks since moving into my new office from the position of Chief Scientist. The FDLI annual meeting offered me the opportunity to highlight a number of FDA’s accomplishments over the last year. The credit for these achievements in no small measure goes to the immensely talented employees at FDA who are committed to assuring safe and nutritious foods, providing effective and high quality medical products, and reducing harm from tobacco products. Credit for these achievements also reflects the extraordinary leadership of my predecessor, Dr. Peggy Hamburg, over the last 6 years.

So today, I’m pleased and honored to present to this audience some of FDA’s accomplishments and challenges, and also to extend my sincere appreciation to FDA’s dedicated work force, who make my new job much easier. But much more importantly, our work force makes the lives of so many Americans safer and healthier. It is with great pride that I look forward to continuing to work with all of you in support of this noble goal.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

World Health Day 2015: A Global Focus on Food Safety

En Español

By: Michael R. Taylor

Food safety is a public health issue that affects all nations – from the most advanced to the most poor. World Health Day, observed on April 7 each year to mark the anniversary of the 1948 founding of the World Health Organization (WHO), gives us an opportunity to reflect on the progress that has been made to address the need for strong food safety systems, and on the enormous challenges that lie ahead.

Michael TaylorThe global importance of this issue is reflected in this year’s World Health Day theme: “Food Safety: From Farm to Plate, Keep it Safe.”  Keeping food safe, from farm to table, is at the core of our mission as an agency and at the heart of the preventive, risk-focused food safety system envisioned by the FDA Food Safety Modernization Act (FSMA).

We’re not alone in recognizing this critical need. Other countries as well are looking for ways to build preventive, modern food safety systems. Just two weeks ago, my colleagues and I were in India to meet with public health officials, regulators and representatives of industry. We all take the same position on food safety: As nations we must be strong individually and collectively, working in partnership to apply controls as foods increasingly cross multiple borders to reach foreign markets.

The challenges are great, starting with the complexity of a global supply chain in which food sources are far flung. There’s the difficulty of building comparable preventive controls in food systems that can vary widely from nation to nation. There’s also the issue of resources, as nations face financial constraints and competing priorities.

And while we can arrive at the best standards, whether they’re based on FSMA or Codex Alimentarius — a collection of international food safety standards, guidelines and codes of practice — we must find a way to verify that these requirements are being met every day in every country. Rules and regulations alone won’t make foods safe. What matters is how we, as an international community, achieve high rates of compliance with standards that prevent illness.

WHO estimates that each year there are an estimated 2 million deaths worldwide from food and waterborne diseases, including many children. In the United States alone, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention.

To bring these numbers down, WHO helps countries prevent, detect and respond to outbreaks of foodborne disease and we are proud to be its partner in advocating for and educating on food safety. This year, in addition to providing a broad opportunity to look at the roles governments and food producers can play in protecting consumers, World Health Day is also focusing on what individuals can do to protect themselves at home by keeping foods free of contamination.

Today WHO will be engaging people worldwide in a social media conversation about food safety. Use the hashtag #SafeFood to share and learn. There will also be a webcast from 10 a.m. to 10:45 a.m. ET in English, and from 11:15 a.m. to noon in Spanish, with a live Q&A session via Twitter and Facebook, using the hashtags: #SafeFood and #SocialGood.

Join the conversation. As individuals, and as nations, we each have a stake in keeping our food safe.

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

From the New CFSAN Director: Reflections on My First Two Months

By: Susan Mayne, Ph.D.

I have been the director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for two months now. What I have enjoyed the most about this new job has been getting to know the people in CFSAN, who come from incredibly varied and interesting backgrounds. I am truly impressed by their commitment to excellence and dedication to our mission to protect and promote public health.

Susan MayneI have also been struck by the depth and breadth of expertise involved in every initiative CFSAN undertakes. So many scientific disciplines are involved: We rely on the insights of our medical officers, toxicologists, epidemiologists, biologists, chemists, behavioral scientists, and nutritionists. Working with our scientists are our policy and communications experts, economists and lawyers. We all have the same goal: to give the safety of food and cosmetics and nutrition issues the thorough and careful consideration they deserve.

We stand on two legs: strong science and our ability to create policy and regulatory solutions to address public health concerns. The scientific fields in which we work, from genomics to toxicology, are advancing rapidly. The use of new technologies can make our science better and help us to get the information we need more quickly. Yet the constant evolution and adoption of new scientific methods can also pose unique challenges — for example, in interpreting trends in food safety and foodborne illness.

When considering the science of food and cosmetic safety, we assess the scientific certainty, severity, and likelihood of any given risk, and identify those people who would be most vulnerable. We consider what additional research can be undertaken to better clarify the science for decision-making, and use what we currently understand to determine whether the risk can be avoided.

For each issue, we need to examine the full range of options, ranging from consumer education to regulation to enforcement. For regulatory options we work with our legal teams to consider what is possible within our authorities. What are we empowered to do and how does our work intersect with that of other federal agencies? If we take an action, what is the international context, and are there foreign trade implications? What are the views of groups that will be most affected by our decisions, on both the consumer and industry sides? What are the costs and benefits? Have we thoughtfully considered how to ensure high levels of compliance?

I have observed with a great sense of satisfaction how we work together with other federal partners. For example, leaders from the Centers for Disease Control and Prevention (CDC) visited our center recently to share information and discuss how we can best support each other in our joint commitment to food safety. In the brief time I have been here, I have also observed interactions with the U.S. Department of Agriculture, the National Institutes of Health, and the Environmental Protection Agency.

CFSAN’s work is funded by taxpayers and affects people’s lives every day. Our work has real consequences for consumers, businesses, and industry. I have learned the importance of engaging in meaningful conversations with those outside of government, who are affected by our decisions. As we talk to our industry stakeholders, we benefit from their expertise and better understand the real-world constraints they face, and that ultimately helps us to put forth more effective policy. Similarly, we value hearing the perspectives of consumers, medical groups, and the scientific community, which often highlight areas where additional FDA focus is needed to protect public health. In our communications, we strive to accurately convey the risks and/or benefits of any food or product, and to rapidly communicate any emerging health concerns.

I have observed an amazing array of public health issues coming across my desk at CFSAN over the past two months. I am energized by the diverse breadth and depth of activity, and look forward to the challenges and opportunities ahead, and to sharing my thoughts and experiences with you on Twitter and in future blog posts.

Susan Mayne is the Director of FDA’s Center for Food Safety and Applied Nutrition