Category Archives: Food

Hurricane Season Is Here – Be Prepared

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By: Pat El-Hinnawy

Bottles of water? Check.
Food for the family? Check.
Dad’s blood pressure medicine? Check.
Grandma’s heart monitor? Check.

It’s hurricane season again. 

Anyone who lived through or watched Hurricane Sandy last year knows the horrific consequences that can follow major storms.  

As we enter the 2013 Atlantic hurricane season, keep in mind that good planning can help ease the burden on you and your family if and when bad weather comes your way.  

And FDA can help. To make sure you have the products you will need to get through a hurricane and its aftermath — including FDA-regulated products such as your food, medicines and medical equipment, — we have prepared a simple checklist.  It shows what steps to take to protect those products you have and to make the right choices as you prepare for this year’s bad weather. The Federal Emergency Management Agency (FEMA) says it’s always best to start with a plan and an emergency kit. 

Your emergency kit should include enough food, water, medical supplies, pet food and supplies, and equipment to get you through the first 72 hours after a big storm or other natural disaster. 

For more tips on how to protect your FDA-regulated items, see FDA’s Hurricane Safety Checklist. 

After the storm has passed, it’s time to pitch in and put your homes and neighborhood back in working order. In a similar way, our field investigators contact local regulated firms that produce or process food, medicines, medical equipment, vaccines and other medical supplies. 

We work with those firms to make sure their products can still meet FDA’s standards before they’re sent to market. For foods, this means the products are safe, wholesome and correctly labeled. For medical products (medicines, medical equipment, vaccines, etc.) it means they are safe and effective. 

Nathan Beck and Valerie Hall are just two of the many FDA specialists working behind the scenes. They draw on an impressive array of data and equipment to quickly develop maps using FDA’s Geographic Information System (GIS). These maps show field investigators how to get around flooded areas to reach industries affected by a hurricane or other emergency. And they provide crucial information to emergency managers coordinating FDA activities.

Many specialists at FDA headquarters also work to support and coordinate the work in the field. They monitor all affected areas across the country to make sure that our investigators have what they need to get the job done. 

We also regularly train for emergencies, and we practice responding to a wide range of incidents, including hurricanes. Recently, we held a hurricane season training session for more than 200 staffers from around the country. 

No one can control where or when hurricanes may strike.  But at the FDA we can, and do, prepare for major storms – and so can you. 

Pat El-Hinnawy is a Public Affairs Specialist in FDA’s Office of External Affairs

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

Food Defense – What’s Your Plan?

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By: Ted Elkin and Julia Guenther

Ted Elkin

While food safety—preventing unintentional contamination from sources likely to be found in the food chain—is a priority for FDA, so is food defense—protecting our food from intentional contamination by saboteurs, terrorists or other criminals.

Such an incident, should it occur, could have widespread public health and economic consequences. Therefore we work hard every day to minimize such risk.

In the last decade, FDA has provided various tools, resources, guidance, and information to the food industry to help them prevent intentional contamination. We work closely with state and local governments, as well as with the food industry, to better understand the vulnerabilities in the food system and identify the appropriate strategies to protect the food supply.

Julia Guenther

Recently, we released a new tool that will help the owners and operators of food facilities develop customized food defense plans to minimize the risk of intentional contamination.  It’s a software program called the Food Defense Plan Builder and it’s designed to be easy to use. This desktop tool can be downloaded free of charge at www.fda.gov/food/fooddefense/.

This exciting new tool guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed, or held there to help the user develop a facility specific food defense plan. The tool will guide owners and operators by prompting them to ask the right questions in food defense planning: What are we already doing to protect our facility? What aren’t we doing that we should or could be doing? What are the vulnerable points within our system and how do we provide added protections? And it even helps with developing a plan to manage, track and prioritize the action steps identified using the tool.

While the use of the Food Defense Plan Builder is voluntary, we strongly encourage food facilities to create food defense plans. In our complex, global marketplace, it’s no exaggeration to say that an incident at one company could affect the whole world.

So, what’s your plan?

Ted Elkin, is Director, Office of Analytics and Outreach, at FDA’s Center for Food Safety and Applied Nutrition

Julia Guenther, is a Policy Analyst, Food Defense and Emergency Coordination Staff, at FDA’s Center for Food Safety and Applied Nutrition

 

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 Collaboration with Chinese Partners Gets Stronger Each Year

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By: Mary Lou Valdez

“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true.  But other times, a change in name can signify some larger, more substantive shift.

The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA). Just weeks before arriving in Washington, during the 12th People’s Congress in Beijing, CFDA had gained new authorities from the Chinese government, and had been given a new name. CFDA became the new moniker for what was formerly known as the State Food and Drug Administration (SFDA). At the same time, it gained enhanced authorities. Most notably, CFDA was given overall authority over China’s domestic system for food safety, absorbing roles previously overseen three other Chinese government agencies. CFDA was also elevated to become a ministry, reporting directly to China’s State Council—the equivalent in U.S. terms of becoming a cabinet-level agency.

But even before this name change and “promotion” within the Chinese government, CFDA had evolved significantly in the years since we began high-level talks with them in 2007. Over the years, these bilateral meetings— which are required annually under the terms of the agreement the U.S. Department of Health and Human Services signed with then-SFDA in 2007—have served as a barometer of our evolving relationship with Chinese regulatory authorities.

Names and titles in the picture (from left to right): Xinyu WENG, Division Director, Dept. of Drug Safety & Inspection, CFDA; Enxue CUI, Council, Bureau of Investigation & Enforcement, CFDA; Zhenjia BIAN, Commissioner's Special Representative, CFDA; Margaret A. Hamburg, Commissioner, USFDA; Jianhua DING, Supervisor-General, Dept. of International Cooperation, CFDA; Lanming WANG, Director-General, Dept. of Medical Device Supervision, CFDA; Xiangyu WANG, Deputy Division Director, Dept. of International Cooperation, CFDA

In 2007 and 2008— years that by all accounts were difficult ones for China with respect to the safety of its exports— exchanges were often challenging, fraught with tension and growing pains. These early efforts represented the first-ever set of talks between senior officials at FDA and then-SFDA, and took place in the context of highly-publicized product-safety issues that dominated those years. Challenges have certainly not gone away in the intervening years, but our April 2013 talks made clear that our relationship with CFDA has matured significantly since those early efforts. Where 2007 represented, in many ways, an introduction, and 2008 marked the first-ever establishment of a bilateral work plan, today, most officials involved in these talks come to the table well-known by their colleagues on the other side of the table. And the slate of topics for our April meeting made clear the deep collaboration between FDA and CFDA across more than a dozen topic areas.

While much of the strengthening of our relationship with CFDA has come through day-to-day collaboration between FDA’s China Office and CFDA officials in Beijing, there are significant ties in multiple areas across our agencies:

  • A working group on economically-motivated adulteration (the fraudulent substitution of a substance in a product to increase value or reduce production costs for the purposes of economic gain) meets on a regular basis by video, linking Washington-based experts with CFDA’s key decision-makers.
  • Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum.
  • FDA and CFDA collaborate closely under the auspices of the World Health Organization’s Working Group for Member States on Substandard, Spurious, Falsely-Labeled, Falsified and Counterfeit Medicines. FDA and CFDA inspectors observe one another’s inspections, and in May 2013, FDA and CFDA will co-host workshops to enhance our collaboration in the fight against internet-based, illegal distribution of adulterated drugs.

The list goes on. Change— of organizational names, of personnel— will continue. Based on our recent talks with CFDA, however, it is clear that one constant will remain: the mature relationship our agencies have built enabling us to better address challenges to consumer and patient safety in years to come.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

Getting to the CORE of Foodborne Illness

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By: Kathleen Gensheimer, M.D., MPH

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese.

Any of these products might show up on your weekly grocery list.

Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months since it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products. After careful analysis, 63 of those incidents were determined to indeed be related to FDA-regulated products and an active CORE response began with one goal: Stop the outbreak.

The highlights of CORE’s work are outlined in our new report entitled “FDA’s CORE: A Food Safety Network 2011-2012.”  As CORE’s director, I could say that I’m proud of what my team has accomplished. But that would be an understatement.

Every day, members of the CORE network at FDA, the Centers for Disease Control and Prevention and state and local agencies, are working to identify, stop and prevent outbreaks. Each outbreak is unique, and so are the results of each investigation. In many cases, though, the network is able to identify, trace and stop an outbreak in its tracks. Contaminated products are pulled out of distribution and removed from grocery store shelves—and hundreds of people may have been spared illness.

CORE introduced a whole new concept into FDA’s response to foodborne illness outbreaks. That is, not just to assemble a team of experts when an outbreak strikes, but to have a full-time, ongoing “core” staff of three teams—Signals and Surveillance, Response, and Post-Response—dedicated respectively to finding the outbreak, stopping the outbreak, and preventing the next outbreak.     

There’s a seamless passing of the baton, and it’s exciting, too. CORE is constantly changing and evolving. Every unique outbreak teaches us new lessons we can apply to the next.

In very short order, CORE proved that FDA could work in close and vital partnership with a huge cast of supporting characters across the country, an extended network of experts from regulatory, public health, agricultural agencies and laboratory staff at the federal, state and local levels. CORE also proved that these partnerships would pay off.

We learn lessons about the science of illness and how it spreads, about the role manufacturers or farmers or packagers or a host of others play. We learn new ways to collect and then crunch the data, and new ways to apply it. We build new relationships and extend our network of experts across the country.

Most importantly, we see first-hand the health hazards that could develop and—if we do our jobs right—we learn how to minimize the chance that they will develop.

So we’re not simply responding to the outbreak. In the intricate chain from farm, to manufacturer, to shipper, to grocer, to your kitchen table, we’re finding ways to help prevent foodborne illness from ever harming you and your family.

Kathleen Gensheimer, M.D., MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

FDA Collaborates with Mexico to Improve Food-Safety Testing

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By: Carl Sciacchitano

En Español

FDA and public health officials in Mexico are working together to increase the capacity and capabilities of laboratories used to test the safety of foods.

In January, 2012, FDA scientists met with Mexico’s National Service of Health, Food Safety and Agro-Alimentary Quality (SENASICA) officials to better understand laboratory operations, practices, methods and quality assurance. Our scientists were also able to visit the SENASICA laboratories and discuss opportunities that would enhance laboratory collaboration and capacity building efforts. 

FDA’s 2011 special report, “Pathway to Global Product Safety and Quality,” states that the agency will partner with nations around the world to enhance global product safety and quality. Additionally, FDA recently released its International Food Safety Capacity-Building Plan that addresses both the acceptance of laboratory methods across the international community and the exchange of information on current and new laboratory methods.

In Mexico, the key objectives of this FDA/SENASICA collaboration include improving communications and laboratory capacity, consulting with SENASICA on the development, validation and implementation of testing methods, and participation in proficiency programs.

To reach our joint goals, the FDA/SENASICA Laboratory Capacity Collaboration Program (LCCP) has been established to enhance our collective ability to strengthen laboratory capacity and capabilities in effective and sustainable ways. 

LCCP participation includes our experts from FDA’s Office of International Programs in Mexico City, Office of Regulatory Affairs (ORA), and Center for Food Safety and Applied Nutrition (CFSAN). Working with representatives from the SENASICA National Laboratories, these experts formed a cohesive unit and prioritized key leveraging opportunities to enhance public health through the LCCP. Highlights of LCCP’s work include:

  • In March 2012, FDA’s Northeast Regional Laboratory (NRL) hosted a Mexican delegation of laboratory experts representing SENASICA’s three main laboratories. NRL provided an overview of FDA’s food testing laboratory, highlighting microbiological and chemical (food and drug) disciplines. NRL scientists shared methods currently used by FDA for the analysis of microbiological and chemical contaminants in foods under FDA’s jurisdiction. A portion of the visit was devoted to discussion and observation of the equipment, laboratory environment and methods used to perform these analyses. Communication channels were created to enhance collaboration.   
  • This effort between FDA and SENASICA scientists was very timely as SENASICA is pursuing efforts to strengthen its laboratory infrastructure for microbiological testing.  The information shared by our FDA scientists directly impacted SENASICA’s early thinking and understanding, resulting in the development of a state-of-the art microbiological testing laboratory. This laboratory will monitor the safety conditions of food during production, processing and packaging through the microbiological analysis of water, fresh produce (fruits and vegetables) and environmental samples of risk areas. In December 2012, we participated in the laboratory opening ceremony in Mexico City. The opening of this laboratory highlights the success of the LCCP efforts.  
  • Mexico’s Sinaloa state lab and FDA provided a training course for SENASICA microbiologists in December 2012 on Pulse-Field-Gel-Electrophoresis (PFGE) and serological techniques. Both techniques are staple methods utilized for the identification and traceback of bacterial strains – critical information that often augments foodborne outbreak investigations. The course was held in SENASICA’s new pathogen detection laboratory.

In 2013, our governments’ goal is to build on the progress from 2012 to enhance public health protection. Sharing information on best laboratory practices and collaborative efforts in method development and validation studies headline some of our key objectives for 2013.

Carl Sciacchitano is a Senior Advisor for Scientific International Affairs in FDA’s Office of International Programs

Leave the Chocolate Out of Rover’s Celebrations

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By: Bernadette Dunham, DVM, PhD, and Carmen Stamper, DVM

Holidays and chocolate seem to go together. For birthdays, anniversaries, Mother’s Day and many other holidays — chocolate is everywhere. But, there is someplace chocolate should never be, and that’s in your dog. Chocolate is toxic to dogs and can kill them. And since a lot of the chocolate treats might be the kids’, make sure to pass along the message to them to never give chocolate to Rover.

Here’s why chocolate is so dangerous for dogs:

Bernadette Dunham, DVM, PhD

Chocolate contains theobromine, a compound in the same family as caffeine.  In certain quantities, theobromine is toxic to dogs.  In general, the minimum toxic theobromine dose in dogs ranges from 46 to 68 milligrams/pound (mg/lb).  Half the dogs that consume 114 to 228 mg/lb or greater of theobromine will die. Lots of things can play a role in whether your dog will have a toxic reaction including the amount of chocolate your dog ate, your dog’s size, and whether your dog happens to be extra-sensitive to theobromine. One of the most important things in chocolate toxicity is the kind of chocolate your dog ate.  For instance:

  • Milk chocolate contains 44 mg of theobromine per oz.  (704 mg theobromine/lb milk chocolate)
  • Semisweet chocolate chips contain 150mg/oz. (2400 mg theobromine/lb semisweet chocolate)
  • Baking chocolate contains 390mg/oz. (6240 mg theobromine/lb baking chocolate)

Carmen Stamper, DVM

So, if we do the math, Rover is eyeing the ears and tail from a leftover chocolate bunny.  How much would he have to eat to get a 46 mg/lb dose of theobromine?  Depending on the type of chocolate, he’d have to eat:

  • 1 ounce per 1 pound of his body weight of milk chocolate bunny
  • 1 ounce per 3 pounds of his body weight of semisweet chocolate bunny, or
  • 1 ounce per 9 pounds of his body weight of baking chocolate bunny.

And, if Rover eats enough chocolate, he might show signs of chocolate toxicity:

Theobromine toxicity can cause a variety of signs ranging from mild to severe.  These signs can include vomiting, diarrhea, rapid heart rate, restlessness, hyperactivity, urinating more, muscle spasms and seizures.

If you think your dog has eaten chocolate call your veterinarian immediately! Only your veterinarian can determine the proper treatment for your pet.

Bernadette Dunham, DVM, PhD, is Director of FDA’s Center for Veterinary Medicine

Carmen Stamper, DVM, is on the Communication Staff of FDA’s Center for 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