Global Reach, Global Safety -- Recipes to Ensure the Quality of Spices
Speech by Margaret A. Hamburg, MD
Commissioner of Food and Drugs
World Spice Congress
February 17, 2014
Thank you, Mr. Ram Kumar Menon, for that kind introduction. I also want to recognize and thank the Chairman of the Spices Board, Dr. A. Jayathilak, for his hospitality. And I want to acknowledge Secretary J. S. Deepak, and thank him for his leadership and support.
I am delighted to be with all of you at this meeting of the 12th World Spice Congress and in this beautiful city. I’ve been in India for nearly 10 days now, and unfortunately, I am approaching the end of a remarkable and engaging visit. Each day has brought new opportunities to meet with fascinating people and tour amazing locations and facilities. We have covered a wide range of issues and, of course, food safety has been an important focus.
These kinds of visits are vital, as our increasingly globalized world…and globalized marketplaces…demand that nations think and act in new ways, working together as never before. For the U.S., the new face of globalization means that over 80 percent of seafood, 50 percent of fresh fruit and nuts, and 20 percent of fresh vegetables are imported from other countries rather than domestically produced. For spices the vast majority comes from other countries including from India. We cannot do our job at home without engaging beyond our borders.
Over the past week, in meetings with government officials and industry representatives, we have further strengthened the important connections between India and the U.S., but I believe our work has broader implications for global health as well. Together we have worked to promote and support a variety of collaborative efforts in the medical product and food sectors that will help better ensure quality and a safer supply chain. In turn, this will lead to additional opportunities for cooperation and shared responsibilities, as well as strengthened accountability. We are committed to developing a bilateral agreement with our counterpart regulators on the foods side in India as a framework for some of our further actions.
It is my belief that visits like this are critical to building relationships and promoting long term progress. My purpose in coming to India was to expand our collaborative activities and advance our work in this region through our FDA offices in India and our partners here -- including government, and especially our regulatory counterparts, industry and academia.
On this point, I want to recognize FDA’s Director of our India Office, Dr. Altaf Lal, and his entire staff for their work here in India. I also want to acknowledge Dr. George Ziobro, with FDA’s Center for Food Safety and Applied Nutrition (CFSAN) who has come from our headquarters to attend this meeting.
This is a most impressive gathering. So many spice experts, thought leaders, grower representatives, policy development and setting organizations as well as leading players from the spice industry, food and beverage industry, and more. I understand that over 40 countries are represented here. This is such an important and timely topic -- and how appropriate that this World Congress is happening in the spice capital of the world. Certainly during my time in India, I’ve had a chance to appreciate the wondrous variety and complexity of spices, and I’ve savored every opportunity to indulge.
It is hard to overstate the role that spices have played throughout world history – in culture, politics, economics, and of course, in cooking. Spices have been a key ingredient in trade among nations for centuries. As Jack Turner described in his 2004 book, “Spices: The History of a Temptation,” ships were launched, expeditions were financed, empires were built, fortunes were made and lives were lost – all in the desire for spices.
Among early civilizations, spices were a fundamental and valuable trading commodity. Spices then catalyzed the Age of Discovery, leading to the fame of some explorers and the demise of others, and helping shape the modern world. And, of course, it can be argued that the discovery of my own country, the United States, was due in no small part to the spice trade, and Columbus’s desire to find a new and faster way to get and deliver cinnamon, pepper and other spices. It wasn’t called globalization back then, but many of the principles were the same, and economics was a driving force.
In many ways, this industry today retains much of the mystery and allure of ancient times. I had the opportunity to see some of that history a few days ago at the Cochin spice market.
But while some of the centuries-old traditions for growing and producing spices have changed little, we also know that this is an industry that in many ways has been greatly transformed, with the modernization of manufacturing processes and a stronger focus on quality and safety. I have seen this transformation on display in the few days I have been here as well.
For example, I had the opportunity to visit a spice processing plant of Synthite Industries Limited, and was afforded a bird’s eye view of turmeric and black pepper flavor extraction. I was pleased to see that this facility uses modern technology and sophisticated practices to ensure the product’s purity and prevent environmental contamination.
During many of my visits and discussions in recent days I have been reminded of the challenges that any industry faces as it grows and tries to keep pace with the demands and pressures of a changing world. This is particularly true, I think, of spices, which combine so many competing and overlapping approaches in how the product is grown, produced, transported and marketed. Few if any products include such an amalgamation of new and old, local and global, and small and large.
Though in some ways, this blend of history and new approaches, reflecting changing realities, needs, challenges and opportunities reminds me of my own agency, the FDA. Begun more than one hundred years ago, the FDA is a science-based regulatory agency with a public health mission to promote and protect health.
Our roles and responsibilities are remarkably broad, overseeing the safety, effectiveness and quality of drugs, medical devices, vaccines and biologics, the safety of the blood supply, cosmetics and dietary supplements, the regulation of tobacco products and of course, food safety and nutrition. To do this important work, we must draw on many disciplines and many areas of expertise. We must work across sectors and we must work across borders as well.
Even though we didn’t always have the kinds of resources and technology we rely on today, from the outset, one of the driving forces has been the understanding that science must always be our guide and the basis for decision-making. That means the work we do to protect the public health, the research we conduct and oversee, and the regulations we issue and implement are driven by data and the best available science.
And we can’t accomplish our ambitious public health mission alone. I cannot over-emphasize the importance of partnerships -- within government and with other governments, industry, academia, the scientific and health care community, and consumers throughout our nation and around the globe. This is essential in every area we work in and is abundantly clear when we talk about foods.
Collaboration can strengthen and extend our understanding of essential scientific factors in the safety of food, offer critical insights into the potential risks and benefits of various products or approaches, and develop a modern, food-safety system aimed at anticipating and preventing food-safety problems. And, to live up to the challenge of leveraging the best science and tools, and to anticipate and respond to future challenges, requires regulatory agencies to be dynamic and communicate results in real-time and with all stakeholders.
Needless to say, it is critical that nations work together to ensure a safe global food supply. Certainly, this is especially true in the area of spices. The spice industry has had an illustrious history, including a unique and essential role in our modern food marketplace, but it also has had challenges relating to contamination and product safety.
But those challenges also offer great opportunities for building stronger systems of safety through enhanced cooperation between nations. I am proud that India and the United States have worked together over many years to demonstrate the power of partnership. I believe that our shared tradition of regulatory science and research, commitment to quality and a willingness to work together toward common goals has proven its value, and offers great promise for the future.
For example, in 1986 and 1987, we discovered that a large percentage of black pepper shipments coming to the United States from India contained filth – and I’m not using that word in its descriptive sense, but as a legal term from our Agency’s defining law. As a result, black pepper from India was placed under automatic detention in July of 1987, which stopped all shipments at the U.S. border. But because of the close relationship and cooperation between the U.S. and India, that was not the end of it.
The following year, discussions between FDA and the Government of India resulted in the implementation of a certification program by the Export Inspection Council (EIC) of the Indian Ministry of Commerce and Industry. This committed the EIC to certify that each lot of black pepper exported to the United States met FDA's requirements for Salmonella, filth, mold and foreign matter. The program proved effective. Subsequent sampling of Indian black pepper from entries with EIC certificates revealed that the program found no violations. That was good news and it illustrates that with a shared commitment and focus, we can address a significant public health and commerce problem in a constructive, forward-leaning manner.
I want to commend India for a number of other ways it has reaffirmed its commitment to strengthening food safety, including the safety of food exports, not the least of which is the theme of this congress, “Sustainability and Food Safety Initiative.” Similarly, the decision to streamline and strengthen food regulation in 2006 through new legislation that reflects the importance of this issue for India.
And there are other noteworthy accomplishments. India has taken the lead in helping to establish the Codex Committee on Spices and Culinary Herbs, and I should note it hosted the successful meeting here in Cochin just last week. India also played a key role in the revisions to the Codex Code of Hygienic Practice for Spices and Dried Aromatic Herbs. These two committees developed standards that can serve as international trade and consumer protection standards on spices and culinary herbs, and offer continuing opportunities to improve food safety. I also want to commend the Food Safety and Standards Authority of India (FSSA) and Spices Board on their plan to establish new laboratories for global standards to support the safety assessment of foods sold in the domestic market and spices exported from India.
Real progress has been made for the benefit of all. But, the challenges of ensuring the continuing safety of spices are significant and will take the ongoing commitment of all of us to fully address. And as you well know these are longstanding issues – that relate not simply to the countries where these spices are grown, but to the unique qualities of the product itself and how it is grown, manufactured, and transported.
It is striking to me that at the FDA we’ve been working on these issues since our very earliest days. More than a century ago, in1907, an FDA report looked at the issue of the adulteration of spices and how to detect it. We continue to work on these issues today.
Continuing concerns about the safety of spice led us to undertake a detailed and data-driven draft study on pathogens and filth in spices. The report, released for public comment last November, and currently open for comments, identified some of the systemic challenges that we are facing in our efforts to reduce some of these commonly occurring microbial hazards and filth in spices. I encourage you to review the report and submit comments.
The report revealed that Salmonella was present in spice shipments offered for entry into the United States 6.6 percent of the time, about twice the average prevalence of all other imported, FDA-regulated foods. Shipments from 79 countries were examined for this study, with 37 countries having Salmonella-contaminated shipments. While some of the contaminated spice can be treated to eliminate Salmonella, and other contaminants are likely to be eliminated during further food processing, this does not necessarily eliminate the potential health risk for consumers identified by the report. The same study found that filth was found in 12 percent of the spice shipments, about double what is generally found in other types of food shipments.
While the data contained in this report are a cause for concern, this is not a problem without a solution. Indeed, there are a number of actions that we are already undertaking, both independently and in concert with other nations, including India, in order to help ensure the future safety of spices traveling through the global supply chain.
And this is happening in the context of a broader set of new food safety initiatives in the United States. In fact, the FDA is now implementing the most sweeping food safety legislation in more than 60 years. Passed overwhelming by Congress and signed into law in early 2011 by President Obama, the Food Safety Modernization Act (or FSMA), gave FDA new authorities that recognize and focus on the importance of strengthening the safety of the food supply by putting in place systems to prevent problems before they occur, rather than simply working to stop outbreaks once happen. FSMA also recognizes the importance of partnership, within and across levels of government, with regulated industry and with a wide array of other stakeholders.
And FSMA isn’t only intended to address food and spices produced in the United States, but it also recognizes the very real challenge of globalization. Indeed, our implementation of the law will provide a number of strategies and tools to improve the safety of spices throughout the global supply chain.
There is an old adage attributed to one of my country’s greatest statesman and early founders, Benjamin Franklin, that “an ounce of prevention is worth a pound of cure.” Well, in passing FSMA, Congress apparently took that aphorism to heart. It shifted our focus from one of reaction and response to outbreaks to one that emphasizes earlier prevention of foodborne illness. This sensible strategy can be compared to that of a doctor who instead of simply prescribing medicine again and again to treat the symptoms of his or her patient’s ailments, works closely with that patient to determine the source of those ailments and prevent the problem from happening in the first place. And as it relates to the safety of foods, it involves all participants in the food system, domestic and foreign, doing their part to minimize the likelihood of harmful contamination.
Our proposed rule for preventive controls for human food would require that makers of food to be sold in the United States develop a formal plan for preventing their food products from causing foodborne illness – whether that food is produced at a foreign or domestic-based facility. The plan would identify potential hazards, put in place steps to address those hazards, verify that the steps are working, and outline how to correct any problems that arise.
Another important proposed rule growing out of this law, the foreign supplier verification program, would require importers to verify that the foods they import are produced using processes and procedures that ensure the same level of public health protection as food produced in the United States.
FSMA also provides the FDA with new inspection and enforcement tools to help ensure that companies are carrying out their responsibilities and to keep contaminated products from entering the market place.
As these rules make clear, the goal and intent of the law is to strengthen the entire global supply system through increased training and sharing of knowledge and greater communication. I’m pleased that FDA’s India office is running a series of webinars for industry on FSMA and U.S. import processes in collaboration with the Export Inspection Council of the Ministry of Commerce and Industry. I encourage you to participate in these webinars. Workshops are also being considered on the preventive control proposed rule, with a focus on spices, seafood, and ready-to-eat food.
Another significant activity we have been undertaking is already demonstrating great promise for the future – the capacity-building projects we are working on in close collaboration with our regulatory counterparts in other countries, including India. In these projects we share some of the best practices we have learned about food safety oversight. We have been engaged successfully in these trainings for many years in a number of areas, ranging from the development of Good Agricultural Practices (GAPs) to aquaculture.
I’m pleased to say that we have begun using this approach with spices too. The Joint Institute for Food Safety and Nutrition (JIFSAN) is partnering with the India Spices Board, the Confederation of India Industry , the Food and Agriculture Center of Excellence (CII-FACE), and the FDA to develop a Collaborative Training Center focused on Supply Chain Management for Spices and Botanical Ingredients (SCMSBI). The goal of the Center is to establish a cadre of in-country experts who can offer training in all aspects of food safety management throughout the supply chain.
We are currently in phase three of a comprehensive “train the trainers” program in India. Phase One, which was filled to overflowing, involved training of more than 70 participants here in Cochin. Phase Two included a more select group of officials, including some from the Spices Board. The most recent part of this program was an extensive 10-day training session in the United States at the University of Maryland Joint Institute for Food Safety and Applied Nutrition and the University of Mississippi National Center for Natural Products Research.
This session included extensive meetings and trainings on every imaginable issue of food and spice safety, covering all aspects of the farm to fork continuum, using individual case studies. Topics have included how to conduct a hazard analysis in processing and storage facilities, identify training needs for Spices and Botanical Ingredients, and conduct cost-benefit analyses. I am told that the participants did occasionally pause for food breaks, but having seen how packed full the agenda was, I am not so sure how they could do this.
I should point out that Cheryl Deem, of the American Spice Trade Association (ASTA), who I believe is at this meeting -- and you will hear from her tomorrow-- made a compelling presentation in Phase Two of the training program, as part of FDA’s collaborative efforts on these issues with that trade association.
We also offer week-long internships in the United States that provide officials from other nations the opportunity to gain further expertise that they can bring back to their own country. Our hope is that these efforts can both strengthen health and food safety in other nations and promote the overall goals of our new food safety law.
There are big changes underway…and there is a huge amount of work to be done. But I am excited about what we are doing and that we are we moving forward with strategies that will make a difference not just for the food that arrives on the shores of the United States, but across this great nation of India, and for the rest of the world.
Our world is in the midst of a remarkable period of transformation, involving an explosion of knowledge, ideas, and capabilities. We live in a time when science and technology – as well as systems of communication and transportation – are dramatically changing how we think about our foods, our food production and our delivery systems -- around the world, and to our dinner tables.
This transformation offers us opportunities – to develop solutions to new and old challenges, including those related to the expanding global nature of our supply chains. We no longer have the luxury of thinking only about the safety of the foods that citizens in our individual communities or nations eat, but we must contemplate the security of the food supply everywhere.
By working together on an international scale, and by collaborating and sharing knowledge in the service of science and improved health, we can develop better and stronger systems to ensure consumers are protected at every step of the food production process, from small farm to large factory, from a spice market to a supermarket. I am confident that together we can meet these challenges. I look forward to our continued cooperation.