Practical Applications of FDA Regulations for the Indian Food Industry

By: Dean Rugnetta

Dean RugnettaGlobalization of the food supply chain and advances in food processing technologies have led American consumers to develop a taste for a variety of foods and cuisines from different countries. Increasingly, U.S. grocery stores sell foods from Asia, Latin America, and many other parts of the world. Indian exporters have recognized this marketing opportunity, and FDA information shows an increase in U.S. imports from India over the past 10 years. A wealth of ready-to-eat Indian specialties can be found in cans and bottles on U.S. store shelves including Indian curries (a.k.a. gravies), canned sweets, pickled cucumbers, and Indian pickles (chopped fruits and vegetables marinated in brine).

A serious potential health risk in canned and bottled foods

FDA’s regulations for processing shelf-stable or commercially sterile food — such as certain canned and bottled foods — were promulgated in the 1970’s in response to deaths related to botulism poisoning. Botulism is a muscle-paralyzing disease caused by a toxin made by the bacterium called Clostridium botulinum.  FDA’s regulations require that processors heat and/or formulate low acid canned foods and acidified foods in a manner that eliminates favorable growth conditions for such toxins.

The regulations also require that supervisors in plants that manufacture such products be trained in appropriate processing methods. In the United States, FDA collaborates with industry groups, academia and other stakeholders to offer “Better Process Control Schools,” which typically provide two to five days of training.

Better Process Control School in India

Better Process Control School Class Group Photo

Students attending Better Process Control School in India

India now has a Better Process Control School where supervisors at any of the 300 FDA-registered facilities can attend training on how to safely process low acid canned foods and acidified foods. The school was established in 2010 when FDA’s India Office partnered with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and a local university in New Delhi, India. The school has convened three separate times since then, most recently this spring. The training helps local processors learn FDA’s regulatory requirements and fulfill a regulatory mandate. Processors that successfully complete the course receive a certificate.

The long-term goal of the training partnership in India is to establish a locally sponsored, self-sustaining class and demonstrates how FDA’s international outreach efforts are improving the safety of imported food products.

Dean Rugnetta is the Deputy Director of FDA’s India Office in New Delhi, India 

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From the New CFSAN Director: Reflections on My First Two Months

By: Susan Mayne, Ph.D.

I have been the director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for two months now. What I have enjoyed the most about this new job has been getting to know the people in CFSAN, who come from incredibly varied and interesting backgrounds. I am truly impressed by their commitment to excellence and dedication to our mission to protect and promote public health.

Susan MayneI have also been struck by the depth and breadth of expertise involved in every initiative CFSAN undertakes. So many scientific disciplines are involved: We rely on the insights of our medical officers, toxicologists, epidemiologists, biologists, chemists, behavioral scientists, and nutritionists. Working with our scientists are our policy and communications experts, economists and lawyers. We all have the same goal: to give the safety of food and cosmetics and nutrition issues the thorough and careful consideration they deserve.

We stand on two legs: strong science and our ability to create policy and regulatory solutions to address public health concerns. The scientific fields in which we work, from genomics to toxicology, are advancing rapidly. The use of new technologies can make our science better and help us to get the information we need more quickly. Yet the constant evolution and adoption of new scientific methods can also pose unique challenges — for example, in interpreting trends in food safety and foodborne illness.

When considering the science of food and cosmetic safety, we assess the scientific certainty, severity, and likelihood of any given risk, and identify those people who would be most vulnerable. We consider what additional research can be undertaken to better clarify the science for decision-making, and use what we currently understand to determine whether the risk can be avoided.

For each issue, we need to examine the full range of options, ranging from consumer education to regulation to enforcement. For regulatory options we work with our legal teams to consider what is possible within our authorities. What are we empowered to do and how does our work intersect with that of other federal agencies? If we take an action, what is the international context, and are there foreign trade implications? What are the views of groups that will be most affected by our decisions, on both the consumer and industry sides? What are the costs and benefits? Have we thoughtfully considered how to ensure high levels of compliance?

I have observed with a great sense of satisfaction how we work together with other federal partners. For example, leaders from the Centers for Disease Control and Prevention (CDC) visited our center recently to share information and discuss how we can best support each other in our joint commitment to food safety. In the brief time I have been here, I have also observed interactions with the U.S. Department of Agriculture, the National Institutes of Health, and the Environmental Protection Agency.

CFSAN’s work is funded by taxpayers and affects people’s lives every day. Our work has real consequences for consumers, businesses, and industry. I have learned the importance of engaging in meaningful conversations with those outside of government, who are affected by our decisions. As we talk to our industry stakeholders, we benefit from their expertise and better understand the real-world constraints they face, and that ultimately helps us to put forth more effective policy. Similarly, we value hearing the perspectives of consumers, medical groups, and the scientific community, which often highlight areas where additional FDA focus is needed to protect public health. In our communications, we strive to accurately convey the risks and/or benefits of any food or product, and to rapidly communicate any emerging health concerns.

I have observed an amazing array of public health issues coming across my desk at CFSAN over the past two months. I am energized by the diverse breadth and depth of activity, and look forward to the challenges and opportunities ahead, and to sharing my thoughts and experiences with you on Twitter and in future blog posts.

Susan Mayne is the Director of FDA’s Center for Food Safety and Applied Nutrition

Teachers Learn About the Science Behind Food Safety and Nutrition

By: Sharmi Das

This past July, middle and high school teachers got a taste of the latest food safety and nutrition information at the FDA’s 15th annual summer training program for school teachers. The week-long program aims to improve food safety and nutrition education in U.S. schools so students are better armed to make nutritious food choices and understand the proper handling of food.

Sharmi DasThe program, called Science and Our Food Supply, uses a curriculum co-developed by FDA and the National Science Teachers Association (NSTA). To date, 652 teachers (from all 50 states, the District of Columbia, and some U.S. Territories) have completed the weeklong training. This year, 32 teachers from 22 states participated in the program and will return to their own schools to teach the curriculum this school year. This class included teachers who specialize in biology, chemistry, food science, health, and family and consumer sciences such as culinary arts.

The creation of a strong network of teachers and students around the country who are “food savvy” is a measure of the program’s success. The program’s participants will reach an estimated 3,200 new students, as well as 640 additional teachers in daylong train-the-teacher sessions, this coming school year. These estimates conservatively reflect the reach of this program – many teachers report using this curriculum to educate consumer groups within their communities, as well as sharing their new knowledge with their own friends and family.

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

During the weeklong program, teachers learned about the journey food takes from farm to table. The training included basic microbiology techniques in a University of Maryland teaching lab, along with introductions to the latest food safety and nutrition research from scientists at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and USDA’s Beltsville Agricultural Research Center (BARC). The teachers heard about new and ongoing research on food safety, nutrition and nutrition labeling, food allergies and food allergen labeling, and cosmetics safety.

In these settings, the teachers not only listened to presentations about relevant topics, but were given ample time to interact with the speakers. Teachers were excited at the opportunity to “ask the experts” many of the questions their students had brought up in class. Lively discussions on the topics of food allergies, color additives, and cosmetics helped teachers understand FDA’s role in regulating several products.

Teachers participating in the 15th year of the Science and Our Food Supply program, FDA/CFSAN

Train the trainer…. Teachers learning about nutrition and food safety through the Science and Our Food Supply program at FDA/CFSAN

At the end of the week, teachers reported on the many ways the training and curriculum will be used to teach their students about food safety and nutrition. “I feel like I can better explain and allow them to investigate better/healthier food choices,” said Victoria Obenchain, of Moraga, Calif. The teachers were also given a variety of educational materials and resources to help them use the curriculum in their own schools.

The FDA-NSTA training program immerses educators in the world and culture of food safety and nutrition for a full week. This experience provides school teachers with a comprehensive farm-to-table perspective on food safety and nutrition, allows them to become familiar with the many and varied backgrounds of professionals in this field, and helps to educate thousands of students about Science and Our Food Supply.

Sharmi Das is the Director of the Division of Education, Outreach and Information in the Office of Analytics and Outreach in FDA’s Center for Food Safety and Applied Nutrition

Next Steps on Arsenic and Rice

By: Suzanne Fitzpatrick, Ph.D., DABT 

On Sept. 6, FDA announced the results of testing 1,300 samples of arsenic in rice and rice products and found that the arsenic levels in rice do not present an immediate or short-term health risk. 

As we said last week, the next step is to assess the potential health risk from long-term exposure to the arsenic in rice and foods made with this grain. 

And that is where my job starts. I am a scientist at FDA and I’d like to explain the scientific legwork that will be done over the next few months by some of the most preeminent arsenic experts in the country. 

This is a daunting task, with one complicating factor being the sheer volume of rice products. When we conducted the risk assessment on arsenic in apple juice that led to the proposed limit, or action level, of 10 parts per billion, we were essentially dealing with one product. With rice, there are different varieties and hundreds of products made with rice. We’ve already started the work. A thorough risk assessment is underway by FDA scientists at the Center for Food Safety and Applied Nutrition, in consultation with colleagues in FDA’s National Center for Toxicological Research and in other federal agencies, including the National Institute of Environmental Health Sciences and the Environmental Protection Agency. 

Scientists and medical experts of all kinds will be working together. I am a toxicologist and will be looking at the data on possible different adverse effects from arsenic exposure in rice. Nutritionists will be studying rice consumption patterns and epidemiologists will be looking for patterns of disease. There will be statisticians, experts on exposure to arsenic, and many others. 

We will use published research on people who have been exposed for years to elevated levels of arsenic in the drinking water. Importantly, we will be looking to see how arsenic may affect the youngest and most vulnerable among us. 

This analysis will take time. As it progresses, the rice industry, university researchers, and the U.S. Department of Agriculture are working to identify ways to reduce arsenic levels in rice during production. This is important because we want to minimize exposure to contaminants like arsenic in our foods whenever feasible. 

In the meantime, let me repeat FDA’s advice to eat and to serve your family a balanced diet that contains a variety of grains, including wheat, barley and oats. Consistent with advice long given by the American Academy of Pediatrics (AAP), we recommend that infants and young children eat a variety of grain cereals for good nutrition. According to AAP, there is no medical evidence that rice cereal has any advantage over other cereal grains as a first solid food. 

My colleagues and I are scientists, but we’re also consumers and parents ourselves. It is our responsibility – our mission –  to put forth the best possible science on this issue – to understand and minimize any long-term risk from the presence of arsenic in rice and foods made with rice. 

Dr. Suzanne Fitzpatrick is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

FDA Scientists Showcase Cutting-Edge Research

By: David G. White, Ph.D.

It’s an impressive sight – 161 posters representing the work of FDA scientists involved in researching food safety and animal health.

This third annual food and veterinary science conference taking place at FDA yesterday and today demonstrates the depth and scope of research conducted by FDA scientists using the most sophisticated, state-of-the-art technology available in the world.

Our research portfolio is rich and diverse for a good reason. We need answers to help us meet our regulatory responsibilities, whether it’s making sure the food you eat, the food your pet eats or the cosmetics you may use are safe. This means knowing how to prevent contamination in produce and other foods, which is the reason behind the FDA Food Safety Modernization Act.  It also means having the right technology to detect contamination to keep harmful products out of the marketplace. 

Several posters, for example, detail how we are at the forefront in our use of a technology called DNA biochips, or microarrays – small, solid supports (glass slides, silicon chips or nylon membranes) onto which thousands of different microscopic gene sequences are immobilized, or attached, at fixed locations. Such microarrays are used to quickly compare the DNA in a sample to previously-identified DNA.

Our scientists have custom-made chips that, for example, contain the DNA of every strain of five pathogens that cause foodborne illness, like E. coli and Salmonella. They’ve also identified and catalogued over 2,900 genes in harmful bacteria that are responsible for antibiotic resistance.

The data has numerous applications for consumers. For example, it can rapidly provide information about how to treat foodborne illnesses, because it can show whether a particular strain of a bacteria is genetically-resistant to an antibiotic that a physician might consider prescribing. If it is, the physician can immediately choose another antibiotic that will be more effective. 

Scientists from FDA’s Center for Veterinary Medicine (CVM) are using the technology to monitor the emergence of pathogens that could become resistant to antibiotics due to their use in food-producing animals.

This technology also allows us to define how virulent a particular organism is – that is, its ability to cause disease — and to identify the mechanisms that make the bacteria resistant to antibiotics.

FDA has also invested in a laboratory process that determines the complete DNA sequence – or order of nucleic acids in a DNA molecule – of a pathogen at a single time. This process, whole genome sequencing, combined with DNA chips will allow scientists tracing the outbreak of a foodborne illness to say definitely, “This person was made sick by this kind of produce, grown and packaged by this company.” The proof is in the genetics. For example, E. coli is made up of about 5,000 genes. Each strain will have some genetic differences. If the genes from E. coli found on a certain bag of sprouts matches the genes of E. coli collected from a sick person, the puzzle of what caused an illness can be solved more quickly.

These projects and many others summarized at the conference were all conducted primarily by scientists from three FDA units – CVM, the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs. The conference being held in our headquarters in Silver Spring,Md., on Aug, 27 and 28, 2013, allows scientists from these three centers to share and discuss their work with colleagues across the agency as well as with federal partners at agencies such as the Centers for Disease Control and Prevention and the United States Department of Agriculture.

Our world-class scientists, doctors, and veterinarians include those with specialties in epidemiology, microbiology, chemistry, toxicology, and pharmacology, to name a few. We are also investing in scientists from a great variety of disciplines and specialties critical to carrying out our mandate to ensure food safety.

We’re in the midst of analyzing all current and anticipated research with the aim of prioritizing what we do so that it’s aligned with the most critical steps needed to protect the U.S.food supply. We are doing that in our labs, in the field, and in the offices where strategic plans are made.

As new hazards emerge and as we develop new technologies, our approaches will change in what is a continual challenge to keep pace with new developments.

The conference demonstrates the brilliance and commitment of our researchers. Their work demonstrates great promise for the future of the agency tasked with ensuring the safety of the food supply.

David G. White, Ph.D., is chief science officer and research director at FDA’s Office of Foods and Veterinary Medicine.