Talking Across International Borders About FSMA

By: Michael R. Taylor

Michael R. TaylorAll countries face the challenges presented by a food supply that is increasingly global, and consumers rightfully expect that the food they eat is safe no matter where it comes from. We all have the same goals: safe food, consumer confidence, and efficient and effective oversight to reach those goals.

With that in mind, our partnerships with foreign food producers and our regulatory counterparts in other countries are increasingly important. As we get closer to releasing the final rules that will implement the FDA Food Safety Modernization Act (FSMA), we are reaching across borders to ensure that our international stakeholders have the information and training they need to meet these new standards.

The need for this international outreach is a message that came through loud and clear at a public meeting this April on FSMA implementation. The feedback from agricultural attaches, overseas business owners, and representatives from governments worldwide was that they want to hear more about what to expect, and how to prepare for what’s ahead.

To address these concerns, we invited representatives of foreign embassies and other international stakeholders to attend a roundtable discussion on June 23, 2015. In the attached video, you’ll see both the optimism and concerns that surfaced during the meeting at FDA’s Center for Food Safety and Applied Nutrition in College Park, Md.


On June 23, 2015, FDA held a meeting of representatives of foreign embassies and international stakeholders involved in implementation of the FDA Food Safety Modernization Act (FSMA). This is the fifth video blog in which the people who will be helping to make FSMA a reality share their insights on challenges, opportunities and next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)


One sentiment, expressed at the meeting, was: “The United States isn’t the only country concerned about food safety.” From FDA’s perspective, we’re counting on that as we build the partnerships we’ll need to help ensure the safety of foods all over the world. We will join forces with agriculture and public health officials in other countries, international industries and associations, multilateral organizations, and academia to address the unique needs of foreign food producers who must comply with the new FSMA regulations.

We’re operating under the premise that the vast majority of food producers, both foreign and domestic, want to ensure the safety of their foods. We will be relying on our international partners to help us find ways to provide solid verification that the FSMA standards are being met.

The earliest compliance dates will be a year after we publish the first final rules this summer. In the meantime, we are working with our public and private partners to develop training for domestic and international food producers. These partners include the U.S. Department of Agriculture, grower and local food system groups, and the Food Safety Preventive Controls and Produce Safety alliances, whose members include the FDA, local and state regulatory agencies, the food industry, and academia.

We are committed to making FSMA implementation as open and transparent a process as possible. The April public meeting and the June roundtable discussion were just two steps in that process. But they were important steps because both provided open and frank conversations.

We’ve got a long road ahead. We’ve long worked with other countries as trading and regulatory partners. Now, we aspire to be food safety partners, working together and supporting each other when problems arise. These partnerships ultimately will benefit consumers all over the world.

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

FDA Science Forum 2015: Views of FDA

FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you can still see all the presentations on our web site.

Looking at the Road Ahead for FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this last of four video blogs, they share their insights on next steps as FDA moves from rule-making to implementation. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face.)

Thinking About FSMA Issues

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this third of four video blogs, they share their insights on the challenges ahead as FDA moves from rule-making to implementation. The next blog focuses on next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the fourth: Voices of FSMA: Moving Forward.)

Continuing the Conversation About FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this second of four video blogs, they share their insights on the opportunities that FSMA makes possible for the global food safety system. The next blogs focus on challenges and momentum. (The first video is Voices of FSMA: The Road to Implementation; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)

Coming Together to Talk About FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. This first of four video blogs focuses on the insights of FDA leaders. Over the next few weeks, the blogs will share the insights of FDA experts and other meeting participants, both in the government and the private sector, on the opportunities, challenges and momentum that FSMA presents. (The second video is Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)

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