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.)

FDA Reaches Out to Minorities During Hepatitis Awareness Month

By: Jovonni R. Spinner, M.P.H., C.H.E.S

Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in May, the public health community commemorates “Hepatitis Awareness Month” to bring attention to this disease, its symptoms, testing, and treatment options. This year, we are working with the Centers for Disease Control and Prevention (CDC) to conduct outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA).

Jovonni SpinnerWhat’s the issue?

Hepatitis, which means “inflammation of the liver”, can cause nausea, abdominal pain, jaundice, joint pain, and malaise. Chronic hepatitis can lead to serious complications like cirrhosis, end-stage liver disease, or cancer. Hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) are the most common strains found in the United States. Knowing your status and getting treatment early can potentially prevent these life threatening complications.

The statistics below show alarming disparities in the number of APIs and AAs being diagnosed with and dying from hepatitis.

Asian/Pacific Islanders

  • 50% or more of Americans living with chronic HBV are APIs
  • APIs experience mortality rates from HBV 7 times greater than Whites

African-Americans

  • 25% of all patients living with HCV are AAs
  • Among 45-65 year old AA’s, HCV-related chronic liver disease is the leading cause of death
  • HCV accounts for 8% of all AA deaths compared to 4% of White deaths
  • Patients with sickle cell disease (which primarily affects AAs) are at increased risk for contracting hepatitis if they received a blood transfusion prior to 1992, when blood banks began screening blood.

What is FDA’s Role?

FDA is committed to advancing the health, safety, and well-being of all Americans through the regulation of diagnostic tests, medicines, and vaccines, as well as monitoring post market safety of healthcare products and ensuring diversity in clinical trials. The most recent safety warning about possible side effects of hepatitis drugs can be found on FDA’s safety bulletin.

One area that my office specifically focuses on is increasing diversity in clinical trials. Data has shown that African Americans and other races respond differently to hepatitis treatments. For example, in the VIRAHEP-C clinical trial, 28% of African-Americans were cured by the tested treatment, compared to 52% of whites. These results highlight why it is important to increase diversity of participants in clinical trials so we can learn how all groups respond to FDA regulated products, thus helping to ensure the safety of medical products for all.

We are actively spearheading FDA’s efforts on the FDASIA 907: Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Under our leadership, we help the agency improve the quality and quantity of data collected; increase clinical trial participation; and increase the transparency of clinical trial data. In addition to the information on our website, we created a clinical trials brochure which discusses the importance of volunteering in clinical trials.

Call to Action

May 19th is National Hepatitis Testing Day!

Spread the word to increase testing and early treatment. These resources are available to help your community:

Patients and health professionals can receive updates about drug approvals, drug safety updates and other issues related to hepatitis by subscribing to the Hepatitis Email Updates.

More information about FDA’s OMH can be found here: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Jovonni Spinner, M.P.H., C.H.E.S., is a Public Health Advisor in FDA’s Office of Minority Health

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.

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