Trans Fat: Taking the Next Important Step

By: Michael R. Taylor 

With all of our worthy focus on implementing the Food Safety Modernization Act this past year, we must not lose sight of other critical areas in which FDA, and specifically the Center for Food Safety and Applied Nutrition, must work and be effective to protect public health. 

One of our core regulatory functions is ensuring that food, including all substances added to food, is safe.  If evidence suggests that a product already in use is unsafe, we take steps to protect the public health. That is what we are doing in the case of partially hydrogenated oils, the major source of artificial trans fat. 

There is a lot of evidence showing that trans fat intake can increase the risk of heart disease by raising low density lipoprotein (LDL) cholesterol, commonly referred to as “bad” cholesterol. Trans fat has been a concern for some time, and that is why ever since 2006, FDA has required that food manufacturers declare the amount of trans fat on the Nutrition Facts label. 

We’ve come a long way since then. In the United States, consumption of trans fat from products containing partially hydrogenated oils has declined dramatically from 4.6 grams per day in 2003 to about 1 gram per day in 2012, according to FDA estimates. And food manufacturers have made significant progress to reduce the levels of trans fat in processed foods. But there are still many processed foods with trans fat including some snack foods, microwave popcorn, frozen pizzas, cakes, cookies, stick margarine products, coffee creamers, pies, and ready-to-use icing products. Many restaurants are also cooking with less trans fat. Elimination of industrially produced trans fat from foods could prevent 20,000 heart attacks and 7000 heart-related deaths each year. 

So now we are ready to take the next important step that could lead to the removal of partially hydrogenated oils from processed foods. Partially hydrogenated oils have long been considered by industry to be “generally recognized as safe,” or GRAS, for their use in food. GRAS status implies that they are regarded by experts as safe under the conditions of intended use. This means they can be added to food without being approved in advance by FDA. 

Because of the evidence linking trans fats to an increase in the risk of heart disease, however, FDA has preliminarily determined that partially hydrogenated oils are no longer GRAS for any use in food. We are providing a 60-day comment period to ask for additional information. If, after reviewing the comments and scientific information submitted, FDA makes the final determination that partially hydrogenated oils are not GRAS and are not otherwise authorized for use in food, such oils become unapproved food additives. That would make their use unlawful unless a company or other petitioner could prove to FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard. 

If FDA ultimately determines that partially hydrogenated oils cannot be used in food, we recognize that it may take some time to phase out their use. Therefore, in our notice we are seeking input on the time that industry would need to remove partially hydrogenated oils from the food supply. If we finalize our tentative determination, we would provide industry with time to comply. 

Consumers who are interested in reducing their trans fat intake can take steps now. First, choose products that are labeled as having “0” trans fat. But under current regulations, even these products can have up to 0.5 grams of trans fat per serving, which can add up depending on what foods you choose. So in addition to choosing products labeled “0” trans fat, you can check the ingredients statement and avoid products that contain partially hydrogenated oils. 

Protecting the safety of the food supply can mean a lot of different things, and this action is just one of the many initiatives FDA is taking to meet its public health responsibility. 

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

Getting Importers’ Pulse About Food Safety Plans

By: Michael R. Taylor

My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year.

We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors - would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.

Members of the import community and food industry attended a public meeting on proposed rules designed to keep imported foods safe.

Earlier this fall, we had our first public meeting on the proposed import rules in Washington, D.C., that was attended by a diverse audience, including consumer and public policy representatives. In Long Beach, the audience was predominantly members of the import community and food industry around the world – including public and private officials from Japan, Thailand, Mexico, Canada and Barbados. Global impact was a thread that wove through all the discussions.

We were very pleased to have with us Sandra Schubert, undersecretary for the California Department of Food and Agriculture, who emphasized the importance of these rules to a large importing and exporting state like California. Across the country, the states will play a very important role in making the food-safety rules a reality.

We learned how the complexity of the global food supply chain could make implementation a challenge. For example, the owners of specialty food stores may have a comparatively small volume of food, but they use many different suppliers around the world. (One Italian foods retailer said that he uses 38 different suppliers in Italy.) They are concerned about the difficulty of requiring all of their small-scale suppliers to verify that the foods are produced in a manner consistent with U.S. standards.

Their complaint is similar to those voiced by small farmers facing a proposed rule that would create new safety standards for the produce industry. They too are afraid of being overwhelmed by logistics and expenses that could put them out of business. As with the produce rule, there are exemptions for small businesses and suppliers. However, some of the specialty importers feel that those exemptions should be expanded.

I was impressed that many of those who spoke at the meetings are thinking ahead to the nuts and bolts of implementation. They asked, however, how we will keep the playing field level – holding all importers and exporters to the same standards. They’ll be at a financial disadvantage if they’re following the rules and others aren’t.

We’ll consider that, and we’ll keep talking. There is clearly no “one size fits all” solution. We want to meet our safety goals with practical, feasible regulations that will work across the wide diversity of food operations.

From Long Beach we drove north to Bakersfield, where we met with growers to discuss the proposed produce regulations. These farmers produce an incredible diversity of crops, including citrus fruits, table grapes, almonds, carrots, leafy greens, green peppers and many more.

We learned a lot in this visit to California. Everything that we heard will be carefully considered as we work on the final version of these rules.

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

Keeping Animal Foods Safe

By: Daniel McChesney, Ph.D. 

Animals are an important part of our lives. Whether we’re talking about a family’s pet or a farmer’s livestock, we at FDA are committed to doing all we can to keep the foods they eat free of contamination. 

To this end, we have proposed the Preventive Controls for Food for Animals rule to establish good manufacturing practices for facilities and personnel involved in manufacturing, processing, packing and holding animal food. It would require facility owners to have a food safety plan and to have controls in place to minimize any potential hazards. 

This proposed rule pulls together the work we’ve done over the past decade to craft a safety system for animal food and will give us new tools to do this important work. The research and findings of the agency’s Animal Feed Safety System Working Group helped create the foundation for the proposed regulations. 

Historically, we have put most of our efforts into responding to safety issues involving animal food as they arise. And while regulations have been crafted to address such threats as the brain-wasting bovine spongiform encephalopathy (aka “mad cow” disease), this regulation moves towards a comprehensive, risk-based regulatory framework to keep all animal foods safe. 

And you can see by looking at some of the crises in recent years this is clearly an important public health issue, one that affects both animals and people. 

Everyone still remembers the massive recall of pet foods in 2007 after melamine, a chemical used to make plastic, was intentionally added to ingredients produced in China, killing pets across the country. 

Just last year, 30,000 tons of dry dog and cat food were recalled following an outbreak of Salmonella tied to a South Carolina facility. The Centers for Disease Control and Prevention reported that 47 people in 20 states and two in Canada fell ill from coming in contact with the contaminated food. 

Globally, public health agencies have for years dealt with the presence of dioxin – linked to cancer and developmental problems in people – in animal food ingredients, and those episodes led to multiple food recalls. 

While FDA moved quickly in response to these and other crises tied to contaminated pet foods, the agency’s focus changed with the enactment in 2011 of the FDA Food Safety Modernization Act. Congress charged FDA to take a more preventive, risk-based regulatory approach. 

While FDA has proposed four other rules this year that were mandated by the food safety law, we chose to handle safety issues involving animal foods separately. Animal and human foods are produced differently, and animals and people are vulnerable to different hazards. 

Also, the rule deals with the nutrient content of animal foods to satisfy a need that is unique to animals. If humans eat a food that’s not particularly nutritious, we can choose something else later. Animals obviously don’t have that option, and they usually get the same food for every meal, so these foods must be complete, nutritionally balanced products.

The bottom line is that we want the foods that animals eat to be safe. We want you to be safe if you’re handling pet food or eating foods derived from animals. This rule will help us do that. You are welcome to read the rule and submit comments by visiting FDA’s official docket at www.regulations.gov or www.fda.gov/fsma

Daniel McChesney, Ph.D., is Director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine.

Help Us Find Out Why Jerky Treats Are Making Pets Sick

By: Linda Tollefson, D.V.M. 

As a veterinarian and lover of animals, I find that working at FDA is a dream job in many ways. In the Foods and Veterinary Medicine program, there are veterinarians in many different jobs that all have to do with keeping both people and animals safe. 

Within the program, FDA’s Center for Veterinary Medicine (CVM) is a working testimonial to animals and their companion people. Desks and office doors are covered with photos of pets — dogs and cats of course, horses for sure, and even our favorite reptiles, birds, cows, pigs, sheep and a few great goats. Water cooler conversations are full of stories about the antics of our friends and family members (with and without fur, fins or feathers) and the challenges of caring for an aging animal. 

That’s why it means so much to us when we are able to target what is making an animal sick, and why it hurts, both personally and professionally, when the cause of illness eludes us despite global efforts to track it down. 

How to Report a Complaint about Jerky Pet Treats

As of September 24, 2013, over 3,600 dogs and 10 cats have reportedly become ill from eating jerky pet treats, nearly all of which were imported from China. While most pets have fully recovered, approximately 580 of these pets have died. The mystery that CVM is trying to solve is this: What is causing the reported illnesses and deaths in dogs (and some cats) that have eaten jerky pet treats made in China? 

The Center has been investigating these illnesses and deaths since 2007, working with experts in academia, industry, foreign governments and state labs. CVM’s Office of Research has been working with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), a consortium of animal health labs nationwide, to examine both animal diagnostic and tissue samples from pets that have become ill and the jerky pet treats themselves. 

Researchers in CVM labs, working together with other labs across the country, have tested jerky pet treats for microbiological contaminants, heavy metals and elements, pesticides, rodenticides, molds, antibiotics and other compounds. We’ve also analyzed hundreds of medical records and lab results, including examining and testing fluids and tissues of sickened pets. FDA inspection teams have visited manufacturing plants and suppliers in China and met with representatives from the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the Chinese regulatory agency responsible for pet food, to discuss U.S. requirements for pet food safety. Jerky pet treats from pet owner’s homes have been tested and compared with store samples. We’ve even made our own jerky to try to duplicate the commercial process. 

So why don’t we know what exactly is causing these illnesses? We’re not sure, but we know that we need more information about the pets that are getting sick. In order to get that information, we need the help of pet owners and veterinarians. To that end, we have issued a “Dear Veterinarian” letter asking veterinary practitioners who treat animals they suspect may have been sickened by eating jerky treats to report these cases to CVM through the FDA Safety Reporting Portal right away so that we can suggest certain tests (and cover the cost of these tests in many cases) when appropriate. We are working with our partners in Vet-LIRN labs across the country to test urine, blood and tissue samples from ill pets that may have been sickened by jerky treats. This collaboration helps leverage our resources and pool scientific expertise for the greatest effect. 

Despite extensive media coverage of the illnesses associated with these products and our own outreach efforts including through the CVM web site, we know there are still pet owners who are unaware of this issue. In response, FDA has developed a Fact Sheet for pet owners that can be made available at veterinary hospitals, pet supply stores, other stores selling pet food, and anywhere pet owners visit. The Fact Sheet explains what symptoms to look for, how to contact your local FDA office, and the status of our jerky pet treat investigation so far. We hope that these tools will help prevent more pets from becoming sick and will provide us with the clues we need to crack the case. 

What we do know is that our pets bring joy to our lives. It’s our mission, both as public servants and animal lovers, to find – and eliminate – the cause of these illnesses. 

Linda Tollefson is Associate Commissioner for FDA’s Office of Foods and Veterinary Medicine

Fishing for a solution

By: Stacey DeGrasse

My collaboration with fishermen began in 2005, when I was dispatched to New England to test the safety of shellfish harvested from federal waters infested by a type of algae that produces toxins. Shellfish that ingest the toxin are not harmed, but if the toxins reach high enough levels, they can make humans who eat the shellfish extremely ill.

The assignment given to me and three other scientists from the Food and Drug Administration: Determine if it was safe for fishermen to continue harvesting clams and other shellfish in the area without endangering consumers.

The high toxin levels we measured in the ocean areas experiencing the expansive bloom of Alexandrium fundyense algae prompted the closure of 15,000 square miles of harvest area to commercial clam fishermen. While it was gratifying to know we were preventing toxic shellfish from harming consumers, it was heartbreaking to look into the eyes of hardworking fishermen and know what the decision meant to their livelihoods.

Years before, in 1990, another Alexandrium bloom had closed to shellfish harvesting the massive Georges Bank, which begins 62 miles off the coast of New England and extends to Nova Scotia. The additional closing in 2005 plunged the clamming industry into crisis.

At that moment, I became determined to play a role in developing a strategy that would someday allow the fishermen to return to traditional fishing grounds while still protecting the public.

I joined colleagues, including FDA’s Paul DiStefano and Steve Conrad, who shared the same goal. Years of research led to a possible solution. The algal blooms come and go, so perhaps the answer was for fishermen to test the clams as they harvested them at sea. That way, the fishermen wouldn’t spend time and money many miles offshore, only to arrive at the docks for their product to be tested by government officials and discover they had returned with contaminated clams they’d have to pay to discard.

We worked with test kit manufacturers to adapt a test originally designed for lab scientists so it could be used by fishermen at sea. Our efforts simplified the kit. Still, the test took about an hour and a half and required precise steps, including keeping track of standards, samples, reagents, timed incubations and data collection. The fishermen would need to do all of this far offshore, sometimes under extreme conditions.

There was a lot of skepticism. First, how would the fishermen react to listening to days of lectures from a young, academically trained, government scientist? Could they accurately conduct these tests that sometimes even challenge lab scientists?

The fishermen, it turned out, are self-taught scientists eager to learn more in an academic setting. In fact, I soon learned that they have spent more time observing science at sea than I have done with my Ph.D. in oceanography. Their observational skills are keen, and they taught me as much about oceanography as I taught them during training sessions on land and at sea.

They shared with me their empirical knowledge about climatological and environmental effects on algal blooms, declines in clam populations due to temperature increases, and changes in whale behavior – to name a few.

While I enjoyed putting on my foul weather gear and participating in the hard work of dredging and shucking clams and testing them for toxins, the most memorable times came when fishermen told me sea stories. Topics ranged from harrowing events at sea to the most unusual organisms and objects they had pulled from the sea. I realized during those exchanges that we all had one thing in common – a love and respect for the sea and all that it offers.

The training worked. As of this year, a large portion of Georges Bank has reopened to commercial clam fishermen who agree to follow the biotoxin control strategy, which includes taking FDA-training to conduct onboard tests of their catch and submitting dockside shellfish samples for a second test conducted by state authorities.

I came to FDA rather than pursuing an academic position because I hoped my research would have immediate applications. My hopes have been fulfilled; it is extremely gratifying to see that our research has made a positive impact on the economy and on fishermen’s livelihood, while ensuring safe seafood for the public.  

Stacey DeGrasse is a research biologist in FDA’s Office of Regulatory Science, Division of Analytical Chemistry, Spectroscopy and Mass Spectrometry Branch

FDA In India: Going Global, Coming Home

By: Altaf Ahmed Lal, Ph.D. 

What is it like to be starting my new position as director of FDA’s office in India

It’s like coming home. 

My new tenure at FDA began in June, but as a former health attaché in the U.S. Embassy, I played an enthusiastic role in helping to establish FDA in my native country. 

I was born in Kashmir, India, and though I left the country in 1980 to explore new professional opportunities in the United States, I have since been drawn back again and again. 

It’s a beautiful, vibrant and interesting country, a unique mix of cultures, languages, and political viewpoints. It’s a country rich in agriculture, information technology and education that is constantly expanding its reach in industry, including the pharmaceutical and biotechnology sectors. It’s second only to Canada as the United States’ largest supplier of pharmaceutical products and in 2011 was the seventh largest exporter of foods to the U.S.

Accepting the responsibility to assume the helm of FDA’s office in India presents a rather daunting challenge. But as my colleagues, and most certainly my wife and three children will tell you, I am not one to shy away from a challenge – quite the opposite. 

In India, it begins with the recognition that FDA, which started as a domestic regulatory agency, has now, by necessity, become a global one. A large part FDA’s role in overseas offices is helping to ensure that products bound for export to the U.S. are safe, of high quality and effective. 

I see our mission in India as three-fold: first, to work closely with FDA’s Indian counterparts, establishing a relationship based on trust and regulations built on solid, scientific evidence; second, to conduct prompt and thorough inspections, when needed, of firms producing products for U.S. export. And third, to help industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential. These three criteria cannot be ranked; each is as important as the next. 

Over the next 12 to 24 months, I look forward to hosting several workshops for open, transparent discussions with industry and regulators on what systems of preventive controls need to be in place throughout the lifecycle of any manufacturing process. What controls do we need to guarantee that at the end of the day, products are safe and effective? Which checks and balances should be standard procedure across the board? 

Part of the challenge is to define those milestones by which we can measure success. I want a manufacturer to ask – and be able to answer – the questions, “Why are we failing inspections?” And “What specific controls do we still need to put into place on a 24/7 basis so that on the next FDA inspection we will pass?” 

I think the answers to those questions can be found in three words: collaboration, coordination and commitment. 

A colleague recently likened my new role at FDA to scaling Mount Everest. But you know, I’m fond of trekking and climbing, and view this next challenge much as I do those activities, as both a challenge and an adventure. I’m eager to be a part of it. 

Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

Reaching Out to Europe on Food Safety

By: Michael R. Taylor

After trips to the Pacific Northwest and New England to connect with growers and state partners on produce safety, I traveled last week to Europe to talk with our regulatory counterparts and others about what the proposed rules under the Food Safety Modernization Act (FSMA) mean for countries that export food to the United States. In Europe, the focus was on all four of the rules we have proposed so far, including two rules proposed in July that implement the Congressional vision of achieving greater importer accountability for food safety.

The U.S. delegation meets with Dutch colleagues at the Port of Rotterdam, the largest seaport in Europe. Jack Vera (center), head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, discusses with Mike Taylor and others procedures required by the European Union for conducting product checks and for sampling and testing product at the Border Inspection Post.

Food safety is a critical issue for all of us in today’s global food system. For consumers in the U.S., there’s a good chance that the food they are eating is imported. Fifteen percent of all the food we eat each year comes from other countries and the percentage is much higher for certain commodities, like fruits and vegetables, seafood and spices. American consumers want to know that imported food is as safe as food produced here.

U.S. food producers and processors also have a stake in the safety of food and ingredients from overseas and rightly want to know that there’s a level playing field – that imported food would have to meet the same safety standards as food produced in the U.S. under the new food safety rules. And it makes sense that European firms and governments are interested in the FSMA requirements we are developing because they want to maintain market access in the U.S.

Our first stop was in Grange, Ireland, just outside Dublin, where the European Union’s Food and Veterinary Office (FVO) is housed. FVO oversees the national food safety inspection programs conducted by the EU’s 28 member states. We had a full day of detailed discussion with FVO director Michael Scannell and his team about FSMA and the opportunity to collaborate on its implementation. The opportunities are great and are important for the U.S. and Europe if we’re to achieve both effectiveness and efficiency in food safety oversight.

There are some differences in how Europe approaches food safety oversight but what was striking to me was that many of the overarching principles that guide us are so similar. In the Netherlands, our second stop, a presentation by Dr. Ron Dwinger from that country’s Food and Consumer Product Authority emphasized basic principles that are very familiar to all of us – a focus on prevention, the importance of addressing food safety from farm to table, the need to base strategies on risk, and the importance of industry responsibility. It was obvious to me that all of us are talking the same language and that food safety reform is a global movement.

While in the Netherlands, my FDA colleagues and I visited the Port of Rotterdam, which is the largest seaport in Europe. The fact that it is a major gateway to the European market for food commodities from around the globe really showed the scale and complexity of today’s modern food system. We were briefed by Jack Vera, head of the Import Inspection Division, Netherlands Food and Consumer Product Authority, about their procedures and strong safety controls over what comes into the country, and we witnessed the sampling of frozen tuna from a large container that originated in Ecuador.

We moved on to Brussels for a critical meeting with our EU regulatory counterparts from DG Sanco, an arm of the European Commission that sets food safety policy and standards for the EU. FDA has had a very positive, ongoing relationship with Paola Testori, the head of DG Sanco. She is a strong leader for consumer protection and a staunch proponent of trans-Atlantic partnership on food safety, including FSMA implementation. Her direct and candid style will help ensure we fulfill our common vision.

We then held a public listening session in Brussels, where we found the same diversity of stakeholders and questions that we expect back home – from government, industry, and consumer groups. Those participating at the meeting represented both the EC and some of the EU member states.

Finally, after traveling to three countries in three days, we left Brussels for Geneva, where we visited our colleagues in the food safety program at the World Health Organization, who play a key role in assuring the scientific quality of international food safety standards, established by the Codex Alimentarius Commission of the United Nations, and in building the food safety capacity of developing countries.

The last stop of our trip was at the World Trade Organization (WTO) headquarters, which sits on the shore of the beautiful lake straddled by the “old” and “new” Geneva. We met there with Gretchen Stanton, who oversees implementation of WTO agreements related to trade in food, and her colleague Melvin Spreij. Trade is important to the economies of developed countries but also for less developed ones, many of which want to strengthen their food safety systems so they can export to markets in the U.S. and Europe. We discussed our international outreach efforts on FSMA and how to help developing countries build their food safety capacity.

With each visit, meeting and listening session we participate in, both in the U.S. or abroad, it becomes clearer and clearer how important partnerships will be to successful food safety reform and how many willing partners we have.

The aspiration for partnership is of course the easy part. Actually building meaningful operational partnerships is much more difficult and will require sustained investment of effort and significant resources. It will be worth it though if the end result is a modern food safety system suited for our global food economy and capable of maintaining the public confidence essential to trade in food, whether domestic or international.

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

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

CFSAN: Pinpointing Priorities, Protecting the Public Health

By: Michael Landa 

When I started my first tour with FDA in 1978, I could not have foreseen the challenges we would face today in our mission to protect and promote the public health. 

Who could have predicted the expanding globalization of the food supply? Or the extent to which technology would transform the foods and cosmetics industries and the ways we regulate them? Who knew that today many consumers would be committed to eating fresh, minimally processed, locally sourced foods? 

As director of the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, I have seen these and other developments in the shifting landscape of food and cosmetic safety. And I am responsible for helping to establish the priorities that will guide our work. 

To this end, I am pleased to share with you the CFSAN Plan for Program Priorities, 2013-2014. The two-year plan - which is well underway at this time – identifies six key program goals and details how we will achieve them. The goals are: 

  1. Reduce foodborne illness rates and cosmetic injury rates each year.
  2. Establish regulations, policies, guidances, and inspection and compliance strategies based on the best science and strategies for prevention and minimizing public health risk.
  3. Increase compliance with new controls focused on preventing foodborne illness and other health hazards. This includes promoting best agricultural practices to farmers, educating consumers on safe food handling practices, and ensuring that safety standards are consistent for both foreign and domestic foods and cosmetics.
  4. Implement science-based strategies that facilitate healthy diets.
  5. Develop and swiftly deploy the fastest, most effective methods for identifying, containing, and eliminating food and cosmetic hazards.
  6. Achieve optimal use of staff and resources. This includes strengthening leadership and management capabilities, enhancing relationships with other regulatory entities at home and abroad, and reviewing and clarifying administrative roles and responsibilities. 

This is not by any means an exhaustive list of all CFSAN initiatives. The Center is continuing other important work that includes reviewing manufacturer premarket notifications for infant formulas; carrying out pre- and post-market regulation of food ingredients and packaging; monitoring for the presence of chemical contaminants in regulated products; authorizing health and nutrient content claims on food products; seeing to it that violative product labeling for cosmetics is corrected; and reviewing premarket notifications for new dietary ingredients in dietary supplements.  

We remain focused on dedicating our resources – human and otherwise – to meeting all of these goals and responding to the challenges ahead.

I encourage you to look at the strategies we will use and the regulatory blueprints we will follow to ensure that the foods you eat and the cosmetics you and your family use are safe. 

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

On Farms and in Labs, FDA and Partners Are Working to Get Answers on Arsenic in Rice

By: Margaret A. Hamburg, M.D.

This week, my colleagues and I traveled to California to learn more, first-hand, about the presence of arsenic in rice.

FDA Commissioner Margaret Hamburg and Deputy FDA Commissioner for Foods and Veterinary Medicine Michael Taylor, center, don hip waders to go out into the rice fields at Lundberg Family Farms in Richvale, Calif. At left is Bryce Lundberg, the farms' vice president of agriculture, and at right is Mike Denny, vice president of farming operations.

This grain, like other foods, contains traces of arsenic, a chemical element found in water, air and soil. However, rice plants absorb more arsenic than most other crop plants. FDA has been monitoring arsenic levels in foods, including rice, for decades.

On Wednesday, Sept. 4, we toured a research facility in which scientists are working to find ways to improve the quality and safety of rice. And we visited the historic farming community of Richvale — a short drive north of Sacramento — known as the birthplace of California rice.

In each of these places I saw a true commitment to public health and a shared goal of ensuring that any risk is minimized so that people around the world can continue to eat rice and rice products as part of a varied diet.

Today, FDA released the results of tests performed on a total of more than 1,300 samples of rice and rice products. What we found was that the levels of inorganic arsenic are well below the levels that would result in any immediate or short-term health risks. This information will now be considered by FDA in looking at the potential long-term health effects associated with the consumption of arsenic in rice and rice products.

Our visit to California, at the invitation of the rice industry – including the USA Rice Federation – was FDA’s third fact-finding visit to rice-producing states, the earlier trips being to Arkansas and Missouri. My traveling companions included Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Andy Hammond, regional director of the U.S. Department of Agriculture’s Agricultural Research Service (ARS).

Our first stop on Wednesday was at the Rice Experiment Station in Biggs operated by the California Cooperative Rice Research Foundation. Research at the station is funded in large part by assessments on rice growers and involves close collaboration with experts at the University of California/Davis and ARS.

Touring the station’s research fields gave us a sense of the determination by all involved in this work, including industry, to better understand how arsenic gets into rice and what growing and processing strategies might be employed to reduce arsenic levels.

That afternoon we visited two multi-generation family farms in Richvale. Lyle Job and his family have been farming their land for more than 30 years. At the Lundberg Family Farms, in business since 1937, we learned about the different approaches of organic rice farmers.

These farmers take enormous pride in their work. They told us about the soil and climate conditions that make their land ideal to grow rice. At the Job farm, we climbed up into a huge harvester to see how it operates. At the Lundberg farm, we put on hip boots and waded out into flooded fields.

Standing beside these farmers, I was struck by their commitment to making the best product possible and the intensity of their desire to help us understand the challenges they face. Rice is not just a commodity to them; it’s their way of life.

Our last stop, on Thursday, Sept. 5, was to FDA’s laboratory in Alameda, where hundreds of rice samples were tested using a process called “speciation.” FDA scientists developed the speciation method used to measuring total arsenic levels, but most importantly to measure both the organic and the more toxic inorganic forms of arsenic.

So what does this all mean right now? As a mother I can imagine that many of you are asking yourself, “Should I be feeding it to my children?” Our best advice – consistent with that given by the American Academy of Pediatrics – is to eat a well-balanced diet that includes a variety of grains.

We don’t have all the answers yet, but we’re working on it. In collaboration with farmers, industry, academia and other public health agencies, we are doing everything possible to determine if the levels of arsenic in rice pose a long-term health risk and, if so, what can be done to reduce that risk.

The presence of arsenic in rice is a global health issue. The answers we seek will ultimately help protect consumers all over the world.

For more photos of our tour, visit Flickr.

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