Category Archives: Food

Celebrating American Heart Month—Making Heart Healthy Choices in 2013

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By: Janelle Derbis, PharmD

Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S.

FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease.

Achieve a healthy weight. Obesity contributes to a number of health conditions, including high blood pressure and high cholesterol. To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise alone, FDA approved two long-term weight management medications in 2012—Belviq and Qsymia. These are the first medications the agency has approved for the treatment of chronic weight management in 13 years.

Quit smoking. Smoking and tobacco use contribute to many health hazards, including heart disease. Nearly half of adult Americans are at risk for heart disease and stroke, and over 20% are at risk due to cigarette smoking. To address the huge public health problem of tobacco use, FDA is building a national tobacco product regulation program to reduce the impact of tobacco use on the nation’s health. Using powerful new regulatory tools provided by the law, FDA’s work supports the objective of the Department of Health and Human Services to end the epidemic of tobacco-related death and disease in America. In November 2012, HHS announced the availability of a new comprehensive tobacco website, BeTobaccoFree.gov, a providing one-stop access to the best and most up-to-date tobacco-related information from across its agencies. This consolidated resource includes general information on tobacco, federal and state laws and policies, health statistics, and evidence-based methods on how to quit.

Eat right. Consumers can eat for a healthy heart and choose foods that are lower in salt, cholesterol, and trans-fat by reading the Nutrition Facts label on food and beverage packages.  In January 2013, the agency announced it is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations. The updates are still being formulated, and public input will be sought when they are proposed.

Lower cholesterol levels.  Making lifestyle modifications can help reduce cholesterol levels. However, hereditary issues can make some people more likely to have high cholesterol levels regardless of diet and exercise. The good news is there are treatment options for people who are unable to lower their cholesterol levels. There are several FDA-approved cholesterol lowering medications on the U.S. market.

In December 2012, FDA approved Juxtapid for a rare cholesterol disorder called homozygous familial hypercholesterolemia (HoFH), an inherited condition that makes the body unable to remove the “bad” cholesterol (LDL cholesterol) from the blood, which  can lead to heart attacks and death before age 30. The approval of Juxtapid is an example of how FDA provides the scientific and regulatory advice needed to bring new treatment options to market.

Control high blood pressure.  Adopting a healthy lifestyle can help prevent high blood pressure. If lifestyle modifications are not enough to lower your blood pressure so that it is within the normal limit (less than 120 over 80), medications are often prescribed. There are many FDA-approved medications to treat high blood pressure so talk with your health care provider to determine which is best for you.

In April 2012, FDA approved the first generic versions of Avapro (Irbesartan) and Avalide (Irbesartan and Hydrochlorothiazide) for the treatment of high blood pressure.  Generic drugs such as these provide safe and effective alternatives to brand-name drugs. 

Exercise. And lastly, physical activity is an essential component of a healthy lifestyle and when done in combination with healthy eating can help prevent heart disease. In 2013, make a commitment to exercising on a routine basis and keep your heart strong!

To receive up-to-date information on heart-related drug and device approvals, safety announcements, and notices of upcoming meetings, subscribe to FDA’s CardioBeat or visit FDA’s cardiovascular webpage.

Janelle Derbis, PharmD, co-manages the Cardiovascular and Endocrine Liaison Program (CELP), at FDA’s Office of Special Health Issues.

FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

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By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.  

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21st century and consider the critical functions of regulatory science and systems that contribute to improved public health. 

Participating thought leaders have included:

  • Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
  • Margaret Chan, M.D., Director-General of the World Health Organization
  • Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
  • Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
  • Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
  • Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.  

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets. 

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”     

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

 

FDA’s Special Role: Ensuring Food Safety at the Inauguration

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By: Margaret A. Hamburg, M.D.

With the presidential inauguration just days away, it’s an exciting time to be in Washington, D.C. The police are setting up parade routes and security. Hotels and restaurants are bracing for crowds.

Margaret Hamburg, M.D.And the FDA is playing an important part as well. For certain events of national significance, such as U.S.-based Olympic games, national political conventions and U.S.-hosted summits of world leaders, we are called upon to marshal our expertise. This week, at the request of the U.S. Secret Service and D.C. Department of Health, we’ve assembled a team of 35 FDA staff from across the U.S. including 18 experts in retail foods and field inspection. Their mission? To work closely with the D.C. Department of Health, local county health departments in Maryland and Virginia, and the FDA Baltimore District Office to make sure that the food served at the inaugural ceremony and parade, balls and galas is safe to eat.

When you think about it, it’s not such an unusual role for FDA. After all, the agency works hand-in-hand each day with state and local public health agencies throughout the U.S. to ensure food safety.

And that’s what we’ll be doing this week. Our team of regional food experts will work with local health departments to protect food from contamination. We’ll review menus and observe food preparation, storage and service. We’ll train kitchen staff about risk factors, such as cleanliness, food temperatures and refrigeration. And information on food sources and supply chains at venues and vendors will be questioned so that if any foodborne illness is reported, we’ll have data to trace it back to the source.  

2009 inaugural salads

Data from the 2009 inauguration tells us that our inspections covered more than 100,000 meals. We expect similar coverage this time around.

It’s a privilege and an honor, but it’s also an enormous responsibility. Fortunately, we come prepared. We tackle this important challenge armed with years of valuable knowledge and experience in careful, data-based, cutting-edge science. We protect Americans from foodborne illness based on lessons learned over a long period of time. 

In ancient Rome, the emperors had special food tasters to make sure their feasts were safe and poison-free. Washington, D.C., isn’t ancient Rome, of course, and the “poisons” we are looking out for may be dangerous microbes.

But just as the Secret Service is responsible for overall security at the inaugural events, FDA is responsible for managing food safety and security in the retail food venues. We’ll work with the chefs and food services and facilities staff in D.C. to ensure that food safety standards are met. As the FDA Food Safety Modernization Act makes clear, our focus will be on preventing food safety problems before they happen.

The standards that FDA and our local health departments will be enforcing in the nation’s capital are the same as those we have in place every day for you and your families. Whether the lucky guests are at an inaugural ball or eating at a stand along the parade route, they can rest assured – as can you - that the regulations are the same for both, and that FDA is doing its part to help ensure that the food we all eat will be safe.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

Basing Food Safety Standards on Science and Prevention

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By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration

FDA Writing New Chapters in Food Safety History

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By: Michael R. Taylor, J.D.

Yesterday, Sunland Inc. entered into a court ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows FDA’s suspension of Sunland’s food facility registration in November as a result of evidence linking Sunland to an outbreak of Salmonella Bredeney that sickened 42 people in 20 states, as well as the company’s history of violations. The company was barred from distributing food in intrastate or interstate commerce while its registration was suspended. 

Mike Taylor, J.D.Yesterday’s consent decree may be seen by some as a final step in the process, but at FDA we see it as a beginning. Certainly, it is a new beginning for the company, which must correct the problems identified during recent FDA inspections before being allowed to market its nut butter products. More broadly, though, it is the beginning of a new chapter in FDA history.

With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce. 

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. 

Paving the way for this new beginning of accountability for food safety was the work of the many employees from FDA and CDC, and state and local governments, who responded to and investigated this outbreak. The work done on this investigation was outstanding. Within days of being notified of the outbreak, our Coordinated Outbreak Response and Evaluation (CORE) network was making headway on the investigation. A link was made between the illnesses and the product and its manufacturer, and our investigators in the field ramped up their on-going investigation of Sunland’s facility to find the source of the outbreak.  

I also think that FDA’s first use of the suspension authority provided by FSMA demonstrates the promise that FSMA itself holds in all its aspects. The suspension of Sunland’s registration demonstrates FDA’s new enforcement tools, but we are also working on other new preventative tools as well. 

As I said earlier, we are writing new chapters in the history not just of FDA, but of food safety. Our response to the recent Salmonella Bredeney outbreak related to peanut butter was a fine example of our newest innovations, like CORE, and using our authority to suspend a registration. But there is still more to come.

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

 

Improving the World through Improved Food Safety

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By: Margaret A. Hamburg, M.D.

Food safety may seem an unusual issue for a lending institution created to encourage growth and reduce poverty in developing countries.

Photo courtesy of the World Bank

The World Bank, however, rightly notes that food safety is not only about public health, as important as that is. It is also critical for economic development, expanded market access and trade, and ultimately for the alleviation of poverty. This week in Paris, the World Bank held its first Global Food Safety Partnership Conference and I was immensely pleased to be able to participate.

The Global Food Safety Partnership (GFSP) is a major milestone on the road to protecting the health of all people in our increasingly interconnected world. Participants represent governments, industry, academia, international organizations and technical bodies.  Among other things, both public and private members are committed to working collectively for stronger food safety systems and strategies.

FDA’s primary mission is to protect the supply of food and medical products in the United States. Increasingly, though, that mission cannot be carried out completely within our borders. Given that we import half of the fresh fruits and 80 percent of the seafood we consume, to name just two commodities, our efforts must be global.

As I noted during a keynote address, the overarching theme of the FDA Food Safety Modernization Act is prevention. The law acknowledges the global movement toward stronger food safety standards and higher assurances that standards are being met, which is a driver of FDA’s transformed import strategy. For FDA, it is essential that we contribute to and rely on capable foreign food safety oversight. Strengthening these food safety systems is the key to maintaining the integrity of the global supply chain. 

Serendipitously, our self-interest coincides with a humanitarian imperative.

Photo courtesy of the World Bank

Up to a third of people in the developing world suffer food and water-borne illnesses every year. More than 2.2 million each year, mostly children, die of those illnesses. Farmers and other food-related enterprises in those countries have little hope of competing in the marketplace as long as their products are suspect.

GFSP is an innovative example of the kind of cooperation we need around the world. It is bringing together food producers and manufacturers, academics, regulators and industry representatives, as well as lenders and borrowers. We all have a collective interest in food safety, and a shared responsibility. When any country improves, everyone wins.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration.

A New Partnership with New Zealand

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By: Deborah M. Autor, J.D. and Michael R. Taylor, J.D.

This week, for the first time, FDA and New Zealand’s Ministry for Primary Industries recognized each other’s food safety systems as providing a comparable degree of food safety assurance at a signing ceremony at the Embassy of New Zealand in Washington, D.C.

One practical result of this arrangement is enhanced information exchanges to avoid duplication of efforts: for example, if the two food-exporting countries decide that their food safety programs and practices provide a comparable level of food safety assurance, they can take this into account as appropriate in determining the type and frequency of inspections to conduct of foreign manufacturing establishments and of imported food shipments.

This means the comparable nations can concentrate more resources, including inspections, on foods that present a greater risk, providing for improved food safety overall.

The arrangement with New Zealand is part of an overall strategy for strengthening the global food safety net through closer collaboration with regulators around the world, highlighted in FDA’s report “Pathway to Global Product Safety and Quality.”

Mike Taylor, J.D.FDA recognizes that, while import examinations are an important tool in helping to ensure that imported foods are safe, we can’t examine every food headed for or arriving at our borders. Instead we make risk-based decisions about which shipments need the least and the most scrutiny at the border. Under the new Food Safety Modernization Act (FSMA), FDA is mandated to expand its import tool kit beyond FDA’s border screening to include stronger importer accountability for verifying the safety of food imports, a much strengthened system of private audits, more FDA inspections overseas, and importantly, greater collaboration with foreign regulatory authorities.

Globally, however, there are major differences in the strength of food safety regulatory systems. For years, we have conducted reviews of various food safety policies and programs in place in other countries to provide assurances of the safety of individual products. The systems recognition process that we completed with New Zealand goes beyond our previous commodity-specific evaluation strategy, covering the overall food safety system that is in place, and how it is implemented, and extending to all FDA-regulated food products.

 

In the past, New Zealand and the U.S. had certain commodity-specific arrangements in place such as ones for seafood and dry dairy products. A scheduled review of these arrangements coincided with the time FDA was starting to consider ways to expand the global safety net through enhanced cooperation with other nations. Both countries thought: Why not try to expand beyond these products to include every product regulated by FDA and its counterpart in New Zealand?

Carol Barnao, Deputy Director General Standards, New Zealand Ministry for Primary Industries, and Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, at the signing ceremony.

That was the start of intense work which began in 2010. FDA, working with New Zealand regulators, comparing every facet of each country’s food safety system—the training of inspectors, procedures for identifying and responding to food safety issues, and legal authority, to name a few.

Once we had confidence in the system on paper, we conducted on-site reviews of the implementation of their programs, to give us an understanding of how their programs worked in practice.

Both countries retain the right to conduct inspections of each other’s products as appropriate. But assured about each other’s competency and commitment, both are more likely to focus their resources on higher risks. Importantly, if a problem does occur, each country intends to work cooperatively on follow up.

The process for conducting systems recognition is still being pilot tested with Canada. FDA will continue to update and refine our process as we work through the pilot with Canada. Systems recognition is voluntary and not required in order for a country to export FDA-regulated foods to the U.S., but any country that believes it can meet the very high bar will have the option of seeking recognition. Meanwhile, we will continue working to foster a global food safety net for all.

Deborah M. Autor, J.D., is Deputy Commissioner for Global Regulatory Operations and Policy

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

China Takes Steps to Strengthen Food Safety

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By: Camille Brewer, M.S., R.D.

An important message came through loud and clear during FDA’s whirlwind visit to China this month: China is determined to strengthen its food safety system. I had not visited China in nearly 10 years and I was struck by the extraordinary progress in the cities we visited. The towering skyscrapers, tree-lined boulevards, and the obvious signs of a rising middle class demonstrate the reality of an economy that has grown by leaps and bounds. That growth has led to rising consumer expectations, and China is clearly working hard to meet consumer and global expectations for safe food. 

This message was repeated in meeting after meeting that Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, and I had with Chinese officials. We saw a clear recognition of the scope and complexity of the challenge as well as a resolve—indeed, an enthusiasm—to take on the challenges head-on, and develop a modern, effective, and efficient food safety system.

Make no mistake: this will not be easy for China.  It has considerable catching up to do in the science and daily practice of food safety and in its legal system.  But the enthusiasm and commitment we saw seems real, and is backed up by action.

China is now implementing its first comprehensive food safety law, which established a Food Safety Committee to oversee all ministries responsible for food safety. The law also calls for the establishment of a national center to focus on risk assessment and risk monitoring to strengthen the scientific underpinnings of food safety regulations.

Earlier this year, China issued a five-year plan for national food safety supervision.  The plan directs the Food Safety Committee and its working office to oversee improvements intended to strengthen China’s food safety regulatory system, emergency response capabilities, supply chain management, surveillance systems, standard-setting activities, and third-party testing. It also calls for improved risk communication and interagency coordination among regulators at central, provincial, and local levels. This plan is testimony to the resolve of the Chinese government to elevate the importance of food safety.

FDA has been working very closely with China for some time to enhance cooperation and address food safety issues of concern. Today, FDA and Chinese food safety authorities renewed an agreement originally signed in 2007. Under the agreement, FDA has helped China to strengthen its regulatory system and better understand FDA’s food safety requirements. This cooperation was made much easier when FDA established offices in China in 2008, enabling us to dramatically increase our inspections and conduct workshops for Chinese government and industry representatives.

On our trip, we also noticed increased consumer interest in food safety. We met with a professor and blogger from China Agricultural University who emphasized Chinese consumers’ concern about economic fraud.  A representative from the Shanghai State FDA and Shanghai Food Safety Committee told us that they have established a consolidated consumer hotline for food safety concerns. 

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

This consumer focus dovetailed well with the presentation made by Mike Taylor at the China International Food Safety and Quality Conference in Shanghai. He noted that consumer confidence in the food supply is an important goal, and what is needed to improve food safety is also what is needed to strengthen consumer confidence in the food they eat. That’s an industry commitment to food safety, credible and effective government oversight, public-private collaboration and partnership, and transparency on the part of industry and government.

He noted that countries other than China are pursuing similar food safety initiatives. In addition to the United States, which is implementing the FDA Food Safety Modernization Act, the Canadian Senate recently passed the Safe Food for Canadians Act, and the Dominican Republic, Madagascar and Vietnam are among countries pursuing modernized food safety laws.

During our trip, we also met with representatives of multinational corporations doing business in China and visited a canned food facility in operation in the Huairou District, a suburb of Beijing.

We know there is still a lot of work ahead to improve food safety worldwide, and efforts by our trading partners must be combined with strong oversight by U.S.government agencies. The FDA Food Safety Modernization Act gives us new tools to improve that oversight, so the elements that are necessary to improve both food safety and consumer confidence are coming together.

The speech presented by Mike Taylor can be accessed at the following link: http://www.fda.gov/Food/FoodSafety/FSMA/ucm326870.htm.

The text of the 2007 agreement, which was officially renewed on December 11, 2012, is available at: http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107557.htm

Camille Brewer is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

 

Helping Authorities Prepare for a Food-Related Emergency

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By: Jason Bashura, M.P.H., R.S.

FDA has prepared a valuable tool that will help its regulatory and public health partners at the state, local, tribal and territorial levels be prepared for disasters that could compromise the safety of the food supply. 

The Food Related Emergency Exercise Bundle (FREE-B) is a compilation of scenarios based on both intentional and unintentional food contamination events. These “table top exercises” can help government regulatory and public health agencies assess their food-emergency response protocols and procedures. Additionally, tools, resources and external links are provided within FREE-B to help in response planning.  

One of the goals is to mitigate the effects of a large scale food emergency. Agencies become like actors in a play, trying out different roles and seeing how well they perform in a given scenario. What are their strengths? Are there gaps in emergency response plans? What relationships must be strengthened to help protect the public’s health and well-being?

FREE-B can also aid agencies that are in the process of revising or developing food emergency procedures. It is designed to allow an agency to interact with multiple partners, such as the medical community, private sector companies and law enforcement. It can also be used by an individual agency to test its own procedures.

Five scenarios currently make up the FREE-B package:

  • How Sweet It Is(n’t) – The regulatory traceback investigation and recall that occurs after testing shows a food product contains high levels of lead. 
  • Stealthy Situation – The nuances encountered when a cluster of illness is associated with a foodservice establishment.
  • Wilted Woes – The epidemiological investigation to identify the contaminated food when there is an unintentional contamination of produce with E. coli O157:H7.
  • High Plains Harbinger – The investigation of animal disease caused by intentional infection of cattle with Foot and Mouth Disease virus, highlighting the roles of animal agriculture and law enforcement agencies during an animal health emergency.
  • Insider Addition – Raw meat has intentionally been contaminated with a chemical agent at the food processing facility.

FREE-B’s overall goal is to facilitate the taking of appropriate, timely and effective steps during emergencies caused by intentional or unintentional acts. It does this by:

  • creating dynamic teams to face critical food emergency incidents;
  • assessing readiness of all involved to effectively address a food contamination incident; and,
  • defining roles and interactions with government agencies and food industry organizations, including understanding the resources that each of these bring to the table.

Users of Free-B are encouraged to evaluate this toolkit and provide feedback to the Food Defense Oversight Team, so that future versions of the tool can better prepare our partners.

Industry, academia and non-government organizations can also benefit from participating in one of these exercises.  Food defense truly is everybody’s business.

Jason Bashura, M.P.H., R.S., is a health scientist on the Food Defense Oversight Team at FDA’s Center for Food Safety and Applied Nutrition

Strengthening Science at FDA to Improve Food Safety

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By: Michael R. Taylor, J.D.

Science is the foundation—the critical underpinning—of everything FDA does to protect public health, and food safety is no exception.   Congress recognized this basic fact when it enacted the FDA Food Safety Modernization Act (FSMA), which is all about harnessing science to understand and prevent food safety hazards.

Mike Taylor, J.D.We are called on to develop science- and risk-based safety standards for a wide variety of fresh produce operators and processing facilities that work under highly diverse conditions and may confront different hazards.  In overseeing implementation of these standards, we are expected to prioritize our domestic inspections and import oversight based on level of risk.  And, as an overarching guide to how we target our risk reduction efforts, Congress has directed FDA to identify what we consider the most significant contaminants in food and devise strategies for addressing them. 

These scientific demands are compounded by the changing nature of the food supply itself and the risks it poses.  We are seeing a dizzying array of new foods in the marketplace, many produced using new technologies.  We are seeing new pathogens emerge, and “not so new” pathogens that show up in foods where we never expected them to be, such as the new strains of disease-causing E. coli in sprouts and diverse strains of Salmonella in produce and peanut butter.   We’re also seeing changes in the practices and profile of the consumers we seek to protect, including an increase in the percentage of the population that is particularly “at risk” for foodborne illness—including the elderly, pregnant women, and immune-compromised individuals.

To meet these challenges, we need new scientific data, new scientific tools, and a new scientific understanding of food safety problems and solutions.  FDA is blessed with a strong cadre of scientists who are tackling these needs through both basic and applied research.  They need and have our strong support.   To take full advantage of our scientific capacity, however, we must move forward strategically.

This means defining our mission needs carefully, prioritizing our research and other scientific efforts in accordance with those defined needs, and building bridges among scientists inside and outside FDA to generate synergies, make best use of resources and widely share the fruits of our collective scientific effort.  

To guide these strategic efforts, we recently created the position of chief science officer and research director.  Since July, Dr. David White has been acting in that position and chairing our Science and Research Steering Committee (SRSC).   Consisting of laboratory and scientific leaders from across FDA’s food safety and veterinary medicine program as well as the National Center for Toxicological Research, the Office of International Programs and the Office of the Chief Scientist, the SRSC has been working for two years, much of it under the leadership of Dr. Jeff Farrar, to strengthen research priority-setting and coordination.  

Among many other things, the SRSC has launched an annual research conference to bring researchers together and last week convened a second annual program-wide research prioritization meeting in which program and research leaders collaborated in shaping our 2013 research agenda.

This work could not be timelier as we face constrained resources and must pay careful attention to priorities and the public health payoff from our research.   The work FDA scientists are doing now to study how common and persistent Salmonella can be in tomatoes and to develop rapid methods to detect Salmonella in animal feed and pet food are good examples of the research we need to be doing.   We are also working at a time of exciting opportunity to take the scientific underpinnings of our public health work to entirely new levels. It is utterly essential to public health and to the success of the nation’s food system that we meet today’s scientific challenges and take full advantage of today’s scientific opportunities.  We are committed to that.  We are fortunate to be working with talented scientists who are more than up to the task.  And we look forward to doing this work in partnership with the scientific community at large.

Michael Taylor is Deputy Commissioner for Foods at FDA