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

Hearing the Concerns of Maine Growers Striving for Agricultural Diversity

This is the fifth in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing.

By Michael R. Taylor

Mike Taylor Visits Bob Spear's Family-Owned Farm Stand

Mike Taylor and colleagues visit the farm stand owned by the Spear family. Bob Spear (center, in the red shirt) is a farmer and a former Maine commissioner of agriculture. He is flanked by Taylor and his wife, Janet Spear.

We arrived Sunday in Portland, Maine, the first stop in our visit to growers and other food producers in New England. The green of Maine in the summer could not be more different from our trip last week to the mountainous desert of the Pacific Northwest.

In Maine, the scale and kind of farming are also different, as are the concerns about FDA’s plans to create science-based, food safety standards. The local-food movement is an important part of the culture here, and a great source of pride.

Many growers are trying to be successful by diversifying or by using innovative business models. Bob Spear, a farmer in Waldoboro and a former Maine commissioner of agriculture, is a good example. He sells much of his crop through his own beautiful farm store, which he and his wife Janet designed, and through community farmers’ markets or directly to stores.

Recently, he has found an excellent new use for some of the winter squash he produces. In the past, he culled and discarded squash with surface blemishes that make then unsuitable for retail sale even though they are perfectly good. Now, rather than throw them out, Spear peels and cuts the squash and sells it to local schools for their lunch programs. It’s a good source of income for him and it’s a good source of fresh, local produce for the schools.

But the fact that he uses his packing house to prepare that produce would make him subject to FDA’s Preventive Controls for Human Foods rule for those activities, in addition to our Produce Safety Rule for other activities. Both rules were proposed in January 2013 as part of the FDA Food Safety Modernization Act. The proposed preventive controls rule would set safety requirements for facilities that manufacture, process, pack, or hold food for people.

Will that discourage innovative approaches like the one Bob Spear has taken? Processing raw commodities creates an opportunity for introducing contamination, but we have to be sure our rules are as practical as possible for each situation.

We heard many variations on this theme of innovation, both in our visits to farms and in a listening session Monday morning in Augusta. Some revolved around the law’s exemption from most of our proposed produce safety rules for farmers whose average food sales are less than $500,000 a year and who sell the majority of that direct to consumers or to retailers or restaurants in the same state, or not more than 275 miles away from them. This exemption, coupled with the fact that FDA has proposed not to cover farms with $25,000 or less in food sales, would mean that many of Maine’s small farmers would not be covered by the rule. In fact, nationwide, we estimate that of 190,000 potentially affected produce farms, 110,000 (almost 60 percent) would not be covered because of their size and manner of distribution.

But exemptions and limitations naturally raise additional questions about how they will be applied. For example, what about dairy farmers who want to try a small produce operation? Would doing so put them over the $500,000 mark when added to their dairy sales? The law says the exemption is based on “food” sales, not produce sales, and this is how FDA has proposed to apply it. Folks in Maine are concerned that this will discourage farmers from diversifying.

Others look at the $500,000 exemption ceiling as a disincentive to grow their produce business. Why should they try to become more successful when their reward will be additional regulatory requirements? In addition, one person I talked to asked what happens if an unexpected jump in sales puts them over the $500,000 sales level. Would they have to be in instant compliance with the produce safety rule? In finalizing the proposed rules, we will try to find practical answers to questions like that.

Just as we saw in the Pacific Northwest, some growers are worried that the cost of meeting food safety regulations will be excessive and could even put them out of business. Our pledge in working toward the final rules is to make them as practical as possible so that we achieve food safety in a way that is workable across the great diversity of American agriculture, from the Pacific Northwest to New England.

Walt Whitcomb, Marilyn Meyerhans and Mike Taylor at Lakeside Orchards

Maine Commissioner of Agriculture Walt Whitcomb, left, Marilyn Meyerhans, owner of Lakeside Orchards, and Mike Taylor.

As we move forward with these regulations, the Cooperative Extension System will be a valuable resource for growers. These federally funded, university-based offices are staffed by experts available to help agricultural producers and small business owners in communities across the country with practical, research-based information. I had a chance to talk with John Rebar, who leads extension in Maine and participated in our listening session. He is committed to food safety and the welfare of Maine’s farmers and will be a great partner in doing this right.

You know the reputation folks in New England have for rugged individualism. Some of the people we met here seemed a bit skeptical of our intentions at first, thinking that we might be big-government bureaucrats going through the motions. I hope we convinced them that our interest is genuine.

Even so, after our visit to the beautiful Lakeside Orchards in Manchester, Maine, I thought it was brave for the restaurant where we had lunch to display this sign: “Welcome FDA.” (And it was an excellent meal!)

Keep watching this space. I will be filing more FDA Voice blogs this week to keep you up to date on what I learn in my travels to New Hampshire, Vermont and Massachusetts.

For more photos of my multi-region tour, visit Flickr.

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

FDA Uses Web Tool to Better the Odds for Food Safety

By: Ted Elkin

When most people hear the words, “Monte Carlo,” they may think about high-stakes gambling.

We, however, think about reducing the risk in food safety through the use of FDA-iRISK, an innovative Web-based food safety modeling tool developed by the Food and Drug Administration and our partners.

Launched in October 2012, FDA-iRISK uses mathematical logic and Monte Carlo simulation (a computer program named for the gambling mecca) to integrate data and generate results that compare and rank risks of the contamination of foods by various hazards.  Unlike a traditional risk assessment of a single food and a single contaminant, FDA-iRISK allows users to compare multiple hazards – microbial or chemical – in multiple foods.

How does FDA-iRISK work?

Through extensive outreach to and collaboration with partners, we developed built-in templates and other features that allow the user to create real-world (or hypothetical) food safety scenarios.

The user provides the data for seven elements: the food(s), the hazard(s), the population of concern (for instance, elderly or immune-compromised), the production or processing system being used for the food, the consumption patterns, the dose response (what level of exposure will have a health impact), and how the health effects are to be calculated.

This allows the user flexibility, for instance, to look at the impact of potential interventions at various stages of the food production system as well as the populations affected.  And it’s easy to use.

Of particular benefit to the user is FDA-iRISK’s ability to generate reports that measure the health impact of an intervention in terms of the widely used public health metric, DALYs (“Disability-Adjusted Life Years,” meaning years of healthy life lost to illness or death).  This measure lets us know the “bang for the buck” of a particular intervention.

FDA-iRISK is quickly gaining acceptance and use in the food safety community.  As of the middle of May, almost 500 users had established accounts with FDA-iRISK and they came from every continent. Because it is web-based, FDA-iRISK is available to anyone in the world who sets up an account, and it is free to use.

Therefore, the knowledge and sharing power of FDA-iRISK is exponential.  As more users use it and generate reports that are then available to the other users, a more consistent, well documented, systematic, structured and quantitative picture of risk in the food supply will emerge, as well as scenarios for reducing risk.

“Information provided by iRisk can aid in developing global scientific exchanges aimed at maintaining and developing agricultural markets around the world,” according to Jamilah (Fagbene) Cassagnol, an international trade specialist at the U.S. Department of Agriculture.

FDA-iRisk is supported by an exceptional project team. FDA staff members Sherri Dennis, Yuhuan Chen, David Oryang, Regis Pouillot, Karin Hoelzer and Susan Cahill developed the tool in collaboration with Risk Sciences International, RTI International and the Institute of Food Technologists.

Ultimately, for food safety, Monte Carlo shouldn’t mean taking a gamble.  Rather, it’s all about using a quantified, standardized and transparent methodology to better understand what interventions and controls will reduce the risk and improve our public health.

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

Food Defense – What’s Your Plan?

By: Ted Elkin and Julia Guenther

Ted Elkin

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

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

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

Julia Guenther

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

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

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

So, what’s your plan?

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

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

 

China Takes Steps to Strengthen Food Safety

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

 

FDA’s Dr. Roberta Hammond: On the Trail of a Salmonella Outbreak

Bringing a wealth of experience in food safety work — from fresh foods to inspecting restaurants — and years of experience coordinating investigations of food and waterborne disease outbreaks for the Florida Department of Health, Roberta Hammond, PhD, RS, joined FDA’s Center for Food Safety and Applied Nutrition (CFSAN) almost two years ago. At the time of this interview, Dr. Hammond was into her third week as Agency Incident Coordinator for the Salmonella Bareilly Incident Management Group (IMG), tracking the source of a recent outbreak of Salmonella infections.

FDA Voice:  Dr. Hammond, thank you for meeting with us during your hectic day.  Can you tell us about this recent salmonella outbreak?  How are things going?  Do you know what caused it yet?  How many people have been affected?

Roberta Hammond, PhD

Dr. Hammond:  Well, we began tracking this outbreak in early April.  So far, we are aware of 148 affected individuals, with 21 hospitalizations.  We’re always concerned when food makes someone sick, but so far in this outbreak there have been no deaths, thank goodness.  Our field investigators have led us to frozen, raw, ground tuna that was used in sushi and possibly other sushi-related dishes.  The source appears to be a company in India that supplies mostly restaurants with this product.  We had a real breakthrough on this investigation — sometimes they are inconclusive, or we never find the source. 

Nevertheless, the outbreak has presented its own set of challenges.  Most of the identified cases were along the Eastern seaboard of the US, with a few in Texas and a few as far west as Missouri.  Strangely, there is no evidence of Salmonella Bareilly on the West Coast or in Hawaii, which is interesting because in the past, we’ve found those areas to have the highest concentration of people who eat sushi.

FDA Voice: You are the Agency Incident Coordinator for this particular Incident Management Group. What does that entail?

Dr. Hammond:  FDA has an excellent incident management process, with an established structure, a clear set of procedures, and an established chain of command. The Office of Crisis Management (OCM) is our focal point for coordinating responses to natural emergencies or emergencies like the Gulf Oil Spill.  FDA’s Coordinated Response and Evaluation Network, what we call CORE, is an agency outbreak-related activities network that was launched in 2011.  CORE typically receives the first news of a human or animal food incident.  CORE begins the investigation, and if the incident begins to escalate through a broader scope, greater severity, increased number of illnesses, or rise in deaths, we have the option to establish an Agency Incident Management Group, or IMG — this is the first IMG activation since CORE’s launch.  If OCM’s Emergency Operations Center approves the formation of the IMG, most of the staff in CORE who have been working on the issue move into the Agency’s IMG center.  Having the multidisciplinary team members working together in the same room enhances rapid information exchange and provides the group with additional operational support so the investigators can focus on their individual tasks.

We start by looking at the places where people think they may have eaten food that made them ill.  From there, we use invoices and other records to trace the suspect food back to suppliers and then to where the food was produced.  State and local health officials and FDA field staff do this work.  They also collect samples of the suspect products that are tested for the presence of the pathogen –the infectious agent suspected of making people sick. For Salmonella Bareilly, we drew on the expertise of more than 60 trained and experienced investigators in 7 FDA district offices and 20 states and the District of Columbia.

The investigation involves close coordination with FDA partners, with Federal partners like the Centers for Disease Control and Prevention, with our State partners, and anyone else who needs to be pulled into the collaboration. FDA’s response is a well-oiled machine, if I may use a well-worn analogy. 

FDA Voice:  What is your specific role during this emergency?

Dr. Hammond:  I help set up the IMG investigative team and then get out of the way.  This is the first time I have coordinated a major outbreak within the Agency IMG structure, and I’m very impressed — the staff at the Emergency Operations Center are outstanding at what they do as are the CORE staff.  I try to stay in the background, making sure the information gets to everyone who needs it.  I see to it that people have what they need to do their jobs.  And I watch for burn-out.  I am also the primary IMG spokesperson on any calls with other Federal agencies and States, and I provide information to FDA leadership. I’d say one of my most important roles is to listen.

FDA Voice:  Can you tell us what a typical IMG day looks like, if there is such a thing?

Dr. Hammond:  First comes the daily kick-off meeting.  I then meet with the section chiefs — planning, operations, logistics, and others.  Then we watch over the work of the nearly 30 people who are tracking down clues about what might be the cause of the outbreak and identifying the steps we need to take to keep the food supply safe.  I attend meetings and conference calls whenever needed, including meeting with the Agency Executive Group and FDA’s senior leadership to consider strategic options for the short and the long term.

FDA Voice:  Dr. Hammond, when does an IMG deactivate?

Dr. Hammond:  You can tell when things begin to wind down. People are no longer working at breakneck speed.  Once the IMG has slowed and no longer requires the intense level of activity, it is transferred back to the CORE staff who tie up the loose ends.  I will sit down with the IMG Section Chiefs and do what’s commonly referred to as a “hot wash.”  We carefully go over everything that has happened — the planning, the logistics, the operations, the communications.  We hope to glean any new understandings that can help us the next time.  And, whether another foodborne illness or a natural disaster, we know there will always be a next time.

Beyond Rulemaking: Building the Scientific Infrastructure for Food Safety under FSMA

By: Michael R. Taylor, J.D.

One year has passed since the FDA Food Safety Modernization Act was enacted, and we are making remarkable progress in developing regulations to implement many of the law’s provisions. It’s certainly a big job, requiring a lot of hard work by many at FDA. 

As we proceed with rulemaking, we also need to be sure we have the infrastructure in place and the resources available to operate in the FSMA environment called for by Congress. FSMA requires industry to focus on preventing problems and on addressing risks in the food supply. But in order to implement the new requirements, FDA will need up-to-date information on what the hazards are, how to detect them, and what steps can be taken all along the farm–to-table chain to minimize them to the extent possible.   

Michael R. Taylor, J.D.

Our existing scientific foundation is strong, but we must be ready for the new challenges posed by FSMA. Our scientific leadership, capacity and partnerships all must be up to the task. One important step we are taking now is to recruit a Chief Science Officer and Research Director to provide strategic direction and lead our research and methods development activities. This individual will work with our scientists and policy experts to be sure that the resources we have available—including expertise and funding—are dedicated to our most critical public health needs. He or she will also need to anticipate our needs for the future.

This means prioritizing research based on our most critical needs and data gaps. This needs to be done strategically across all of our food programs and in concert with other research offices within FDA. It means determining what new methods, such as rapid analytical tests, are needed to identify contaminants in foods and to ensure that industry is meeting our food safety requirements. And, it means collaborating with other research entities in the public and private sectors.

By working closely with our research partners in other government agencies, academia and industry, we can leverage each other’s work and avoid duplication.

FDA chemist uses gas chromatography to measure levels of melamine in food samples. Our Chief Science Officer and Research Director will also make sure we identify and invest in scientific disciplines and specialties that are critical to carry out our mission. Science and technology change rapidly, and we must have the right expertise, training, equipment and facilities to keep up.

A lot is at stake. FSMA provides the framework for the new prevention- and science-based food safety system, but we must have the science to support the framework and make the right decisions to protect the public health. Americans expect us to have the right science at our fingertips to protect themselves and their families. FSMA must be accompanied by change within FDA so we are ready to operate the new food safety system – and we are ready to meet that challenge head on.

Michael Taylor is Deputy Commissioner for Foods at FDA

Don’t Worry About Your Orange Juice

By: Michael R. Taylor, J.D.

You may have heard something on the news about low levels of a pesticide found in some orange juice products that are a blend of domestic and imported orange juice.  Here are three reasons you do not need to worry about the safety of that glass of orange juice you are about to enjoy.  

First, in the United States, we have a public health goal to fully protect people from harmful pesticide residues in the food we consume, and we have a system in place to do just that. Before the Environmental Protection Agency (EPA) sets “tolerances,” or the maximum level of pesticide residue allowed on a food, it first must determine that the pesticide residue level is safe in food.  It is then FDA’s responsibility to ensure that those tolerances are not exceeded on the foods it regulates.  If a tolerance has not been set or there is no exemption from a tolerance, companies are responsible for ensuring that their products do not contain pesticide residues.

In this case, FDA recently learned that a company had detected very low levels of the pesticide carbendazim in its own and its competitor’s orange juice products.  While carbendazim is used in Brazil and some other countries to protect against a type of mold that grows on orange trees, it is not used in the U.S., there is no EPA tolerance set for it and it is an unlawful pesticide residue.  It is also important to note that three quarters of the juice consumed in the U.S. is from oranges that are grown in the U.S. The implicated orange juice from Brazil accounts only for a much smaller proportion.

Second, FDA is testing orange juice products being imported into the United States and will not permit their entry into the U.S. until our testing and analysis confirms that the orange juice product complies with our laws.  This means that the orange juice products entering the country from Brazil or anywhere else are safe for consumers.  It also serves as a reminder to other food companies not to allow illegal pesticide residues on their products entering the United States.

Third, FDA immediately consulted with EPA, which conducted a risk assessment and found that the levels being reported for orange juice products already in the United States were far below any level that would pose a safety concern.  For that reason, FDA determined that a recall of orange juice already on the market is not warranted.  However, FDA is testing orange juice products for carbendazim in the U.S. and if we identify orange juice with carbendazim at levels that present a public health risk, we will alert consumers and take the necessary action to ensure that it is removed from the market.

We recognize that from time to time problems in our food safety system occur, particularly with increased globalization.  With limited resources, we obviously cannot be everywhere at once.  That’s why we target our efforts on those products that pose the greatest risk and act promptly when problems are brought to our attention.  In this case, FDA and EPA quickly assessed the health risks and made a decision that protects consumers without creating unnecessary disruptions to orange juice products already on the market. 

What does this mean for consumers?  Continue to enjoy your orange juice.

 Michael Taylor is Deputy Commissioner for Foods at the FDA