Tag Archives: FDA Food Safety Modernization Act

Science Is the Foundation of Food Safety at FDA

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By: Michael R. Taylor, J.D.

Science is the foundation of everything we do at FDA to keep your food safe.

Michael R. Taylor, J.D.The Food Safety Modernization Act that President Obama signed into law in 2011 emphasizes prevention of foodborne illnesses. Margaret Hamburg, FDA’s commissioner, has made it our priority to base the agency’s regulatory decisions on sound, cutting-edge science.

We’re on the case.

The Office of Food and Veterinary Medicine (OFVM), which I am privileged to lead, is acting on a number of fronts to strengthen its scientific foundation. I am pleased to welcome David White as OFVM’s chief science officer and research director. Dr. White previously served as the director of the Office of Research at FDA’s Center for Veterinary Medicine. Palmer Orlandi Jr., another veteran scientist at FDA, is now our office’s senior science advisor.

We are marshalling our forces to work in the strongest, most effective way to keep the food that you eat, the food that you share with your family, free of dangerous levels of chemicals and bacteria like Salmonella, Listeria and E.coli.

We are prioritizing the work of our scientists in laboratories across the country based on which potential contaminants, such as disease-causing bacteria or chemicals, post the greatest risk to you.

Dr. White is the chairman of FDA’s Science and Research Steering Committee, which is made up of representatives from agency’s offices and center involved in food safety. These experts talk about research projects, before they even start, to ensure that everything we do furthers the goal of addressing the greatest threats to food safety.

FDA scientists are taking many different paths to that goal. Some respond to emergencies, working to rapidly identify the source of an outbreak. Others work longer term, exploring the genetic makeup of disease-causing bacteria and recovering information that will facilitate rapid identification in the future. Because science is always evolving and advancing, there are scientists who work to make sure that FDA has the most advanced tools with which to evaluate new technologies.

Scientists are developing new ways to detect bacteria like Salmonella in foods that include leafy greens, spices and pet foods. These tools will be invaluable surveillance tools that will help FDA prevent illness outbreaks. We are also exploring if certain bacteria would inhibit the spread of their disease-causing brethren if applied to tomatoes and other crops. This is just a sampling of the research that goes on every day at FDA.

FSMA gave FDA a mandate to implement a system that emphasizes prevention and prioritizes food safety challenges based on the risk they present to public health.

Our job is to make that mandate a reality. Part of the challenge is constantly evaluating our science and research agenda to make sure that it mirrors our public health priorities. These priorities change shape as bacteria evolve, new hazards emerge and new food-producing technologies are developed.

When you hear about science at FDA, there’s nothing theoretical about it. We are continually identifying the greatest threats to food safety and meeting them head on.

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

Let’s Keep Talking—and Listening—About Food Safety

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By: Michael R. Taylor, J.D.

Everyone has a stake in the rules that FDA is proposing to strengthen the food safety net in this country.

Michael R. Taylor, J.D.We have reached out far and wide to engage in conversations about the first two proposed rules mandated by the FDA Food Safety Modernization Act. The produce safety rule would set standards for production and harvesting of fruits and vegetables. The preventive controls rule for human food would set safety requirements for food facilities.

Since these rules were proposed in January 2013 and published in the Federal Register for public comment, my colleagues and I have been engaged in an ongoing dialogue with a range of consumers, farmers, manufacturers and others who are affected by the proposals.  When we say that we want the public to comment, we mean it. We need that feedback to ensure that what we plan to do is what we should do. In fact, we have extended the comment periods for both proposed rules for another 120 days.

I recently met with tree fruit farmers from Washington State who wanted to talk about how they would be affected by proposed standards for irrigation water. I’ve attended other small-group meetings with a cross-section of people and organizations concerned about what these rules will mean to them. And our FSMA implementation team has been providing overviews of the proposed rules and answering stakeholder questions every day since the rules were first published.

On a larger scale, there have been three public meetings, in Washington, D.C., Chicago and Portland,OR. At each meeting, the crowd was large, diverse, and intensely interested, asking detailed questions about the basis for certain provisions and how they would work in specific cases. We learned a lot that will help us address these questions and be sure that the final rules are both effective for food safety and workable across the great diversity of the food industry. 

We also learned that a broad cross-section of our industry and consumer stakeholders are eager to push forward and work with us to successfully complete this crucial rule-writing step in FSMA implementation.   

None more so than 15-year-old Rylee Gustafson, who nearly died from eating contaminated spinach six years ago. She spoke in Portland:

“When people ask me why I am passionate about food safety, the answer is simple:  I don’t want anyone to have to go through what I did—or worse, die because of something they ate. I have been able to take my experience and make a positive impact by sharing my story. But my job as a food safety advocate is far from over. Being here today—to support the FDA in the release of the proposed produce safety rule and to encourage the agency to finalize it quickly with the hope that fewer people, young and old, are forced to suffer because of foodborne illness—is just the next chapter in my story.”

Rylee reminds us why we do this work and why we are so committed to helping write that next chapter.

There are three more FSMA-mandated proposals on the horizon that form the basic framework for a modern, prevention-based food safety system. Two are designed to keep imported foods safe from contamination and the third is to protect animal food. Then, as now, we will want your opinion of what we’re planning. We want to engage you as partners in making these reforms a reality.

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine

FDA’s International Food Safety Capacity-Building Plan: Improving Food Safety Protections Around the World

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By Julie Moss, Ph.D., R.D., and Katherine Bond, Sc.D.

Our increasingly globalized world means that more and more of the food we eat is imported. Congress recognized this fact of modern life by passing the FDA Food Safety Modernization Act (FSMA), landmark legislation signed into law in 2011 that shifts the emphasis from responding to food safety incidents to preventing them.

Julie Moss

In that spirit, Congress saw the importance of improving the capacity for food safety protections. It directed FDA to develop a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the United States.

FDA has met that challenge, recently releasing its International Food Safety Capacity-Building Plan, which provides a strategic framework intended to guide FDA’s capacity-building efforts over the next five years. FSMA marks the first time that Congress has charged FDA with comprehensively addressing the building of international food safety capacity, a development that has been very exciting for us.

While this mandate is new, we have successfully supported food safety capacity-building efforts and conducted training programs for many years. The agency has participated in global, multilateral food safety programs, including work with the World Health Organization, train-the-trainer programs (in areas such as good agriculture practices), various seminars and web postings, and collaborations with other U.S.government agencies, among other efforts. However, FSMA allows us to take this work to a whole new level.

For example, we are working with foreign governments to see if we can exchange more scientific and technical information, such as outbreak and inspection data. This will open up communication channels and promote collaboration with those governments. We are also working to support both the acceptance of laboratory methods across the international community as appropriate and the exchange of information on current and new laboratory methods. This helps ensure that the data obtained from different domestic and international laboratories is of good quality and can be easily compared.   

We have developed a plan that incorporates many of FSMA’s main principles, including comprehensive prevention, risk-based resource allocation, and partnering. The plan’s key goals are:

  • Goal 1: Ensure efficiency across the Foods and Veterinary Medicine Program
  • Goal 2: Increase effectiveness through evidence-based decision making
  • Goal 3: Support the exchange of information between FDA and other foreign government agencies or other entities
  • Goal 4: Enhance technical assistance and capacity-building in food safety

    Katherine Bond

Overall, the plan charts a direction for how we will prioritize our capacity-building efforts based on risk, how we will link capacity-building efforts to their impact on public health, and how we will work in partnership with counterpart authorities, industry and other organizations to achieve lasting food safety results. Through this plan, countries that export to the United States will have an opportunity to learn about our food safety capacity-building priorities and see the breadth of the efforts that we are pursuing.   

In developing this plan, we consulted with foreign governments, industry, non-governmental organizations, certain U.S.officials, academia and other stakeholders. A public meeting was held on June 19, 2012, and comments received were considered in development of the plan [Docket No. FDA-2012-N-0437].

Given the breadth of this work, it is essential that we collaborate with partners to get the work done. We realize we can’t do it alone. Partnerships are important in everything we do, and even more so with capacity building. We also recognize the importance of establishing strong relationships and mutual support among all stakeholders from farm to table. As we begin to implement this new plan, we look forward to sharing ideas and new information with our international counterparts and other interested stakeholders, leveraging resources that will help us improve global food safety.

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Katherine Bond, Sc.D., is Director, Office of Strategy, Partnerships and Analytics, in FDA’s Office of International Programs

 

Public Meeting on Food Safety Highlights First Two Proposed Rules

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By: Michael R. Taylor

Last week, we kicked off a series of public meetings—with about 400 people participating—to stimulate dialogue and gain input on FDA’s first two proposed rules to implement the FDA Food Safety Modernization Act. In her opening remarks, Dr. Hamburg noted how her appointment as FDA Commissioner by President Obama, coming on the heels of the illnesses and deaths attributed to contaminated peanut products, helped make food safety a high priority for her and the Administration.

Michael R. Taylor, J.D.It was fitting that we held our first meeting in a USDA auditorium in Washington, D.C., because we have worked closely with USDA and with other government partners at the state and local level, as well as with industry and consumer groups, to get the rules right.  That means holding a lot of meetings to explain the proposed rules, visiting farms and facilities, and opening dockets for comments from interested parties, to receive as much input from the public as possible before we finalize the rules.

The diversity of those who signed up to make public comments at the meeting shows how important food safety is to all of us, from victims of foodborne illness to farmers and food manufacturers. First up was 15-year-old Dana Dziadul, who was three years old when she became ill from Salmonella in cantaloupe. The compelling stories from Dana and other victims of foodborne illness, and their families, remind us all that first and foremost, we have a public health obligation to address the harsh reality that each year, 3,000 people die and more than 100,000 are hospitalized because of foodborne illness. Our first obligation is to do everything we can to reduce these numbers.

We also know that improving food safety helps avoid the disruptions in the marketplace that result from illness outbreaks and recalls of food and maintain consumer confidence in healthful foods, such as the produce that the proposed rules cover. This convergence of interests has made our current food safety initiatives a real community effort, with industry, consumers and government coming together around the common goal of modernizing our food safety system to better prevent problems. We all have a responsibility, and we all have a role, in making and keeping food safe.

The work ahead may sound simple—having the right standards in place that are based on the best information we have on how to prevent hazards, and making sure these standards are met. But we have much yet to accomplish. We have to make sure the standards are flexible enough to address the diversity of operations across the country—from small farms to large facilities, from Maine to California. We also need to be sure FDA is ready to operate under this new, prevention-oriented framework, which will require employee training and ensuring our resources are focused on the greatest risks. And we are committed to providing technical assistance so that industry, especially small operations, can meet the new requirements when they are finalized.

These two proposed rules we have announced are very important, but we have three additional rules coming to further form our food safety framework. To address the safety of imports, we will soon be proposing a rule that requires that importers based in the United States verify that their overseas supplies are following prevention-based standards that provide the same level of public health protection as those that are in place here. Also addressing imports is a proposed rule on the accreditation of the third party auditors that industry uses to help them determine if food safety standards are being met. The third proposed rule coming addresses preventive controls for animal food, including pet food.  Preventive controls are steps that firms must put in place to control hazards such as microbial contamination that could occur in a food facility.

We will be holding two more public meetings—one in Chicago and one in Portland, Oregon. You can find more information on our web site at fda.gov/fsma. Six meetings in various states across the country also are scheduled. Your comments are important to us, and I encourage you to submit comments at regulations.gov before the May 16th deadline. 

The road ahead is a long one, and it will take years, and sustained commitment, to have our framework fully in place. But, for America’s families and our vibrant food system, the hard work is absolutely worth it!

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

 

We’re Taking Steps to Enhance the Safety of Cantaloupe for Consumers

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By: Michael M. Landa

The growing and harvest season for cantaloupe in the United States is beginning and FDA is working with its state partners and the produce industry to make sure that this is a good, safe year for lovers of this nutritious fruit.

As FDA works on implementing the produce safety standards mandated by the FDA Food Safety Modernization Act, it is essential that those involved in growing, harvesting, and distributing cantaloupe – and produce in general – follow agricultural practices that FDA and the produce industry have identified as effective in minimizing the risk of contamination. 

FDA is now issuing a letter to firms that handle cantaloupe to help reduce the chance that the fruit may be contaminated by harmful bacteria. Our letter has two key messages.

First, it reminds firms to follow good agricultural and handling practices to protect the safety of their product. Second, it informs these same firms that FDA will be inspecting packinghouses over the course of the upcoming growing and packing season to, in part, assess current practices and identify conditions that may adversely affect the safety of cantaloupe.

Two major outbreaks of foodborne illness in 2011 and 2012 were associated with cantaloupe. Preventing this from happening again has been a team effort.

The cantaloupe industry has worked hard since then to revise and update its own food-safety guidelines. In California, the industry has required implementation of its new best practices via a state marketing agreement.

Our colleagues in state agriculture departments are planning their own efforts with growers to enhance cantaloupe safety.

FDA stands ready to provide technical assistance to industry and to work collaboratively with our state partners, retailers and others in pursuit of our common goal to enhance food safety.

Michael M. Landa is Director of FDA’s Center for Food Safety and Applied Nutrition