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.

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

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 Taylor

Michael 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.

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

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 Taylor

Michael Taylor

To 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