50 States, One Goal: Working Together to Keep Our Food Safe

By: Melinda K. Plaisier and Michael R. Taylor

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

Melinda K. Plaisier

The August 12 conference in St. Louis of the Partnership for Food Protection (PFP) was truly a meeting of the minds. This 50-state workshop drew food and feed safety experts from federal, state, local, tribal and territorial government agencies. These organizations make up the PFP. Our shared goal? To continue working towards a food safety system in our country that makes our food as safe as possible.

Partnerships have become increasingly important in our efforts. Simply put, we can’t do it alone. The scope of the public health mission is too vast. We need to take advantage of the unique contributions state and local partners can make through their food safety commitment, knowledge of local conditions and practices, and local presence to deliver training, technical assistance and compliance oversight. Together, we can ensure an effective public health safety net.

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

Michael R. Taylor

But building the kind of partnership we envision is an extraordinarily complex task. There are 3,000 food safety agencies in this country at the federal, state and local level. The challenge we face is this: How do we make PFP a reality that will work for decades to come? Working together to corral the complexities of our global food supply is critically important to our success and represents a significant shift in the way we work.

And creating that new reality is what our recent meeting was all about.

FDA itself is in a time of transition through Commissioner Hamburg’s initiative of program alignment. The agency is working to better align internal operations, increasing specialization among inspectors, compliance officers, laboratory staff and others to give them increased technical knowledge in a specific commodity area, and partnering them with subject matter experts in FDA’s centers. Ultimately, this will streamline decision-making and provide real-time technical and policy support for frontline staff.

This effort will better position FDA to meet the challenges we face, including the continued evolution of science and technology, the reality of globalization, and implementing the rules we are working to finalize that will help make the FDA Food Safety Modernization Act (FSMA) a reality—each rule,  in its own way, transformative.

Speaking with one voice as an agency and acting in unison across internal boundaries will enable FDA to better support our state partners as we all work to use innovative tools, training and approaches.

Our collaborations with the Association of Food and Drug Officials, the National Association of State Departments of Agriculture, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials, the National Environmental Health Association, and the Association of Public Health Laboratories—just to name a few—are equally valuable in this cause.

We are well on our way toward making our partnership through PFP a foundation of the modern infrastructure we are building to protect public health. Our partners are engaged, and FDA is all in. And now we are truly beginning to see some of the fruits of our labor. Until we meet again, our work continues.

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

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

On the road from Mexico: a model for regulatory cooperation

En Español

By: Margaret A. Hamburg, M.D.

Margaret Hamburg

FDA Commissioner Margaret A. Hamburg, M.D., meeting with Mexican public health and regulatory officials in Mexico City this week

This week I’m making my first visit to Mexico as FDA Commissioner and, while I am savoring the rich culture, warm people and delicious food, the trip is providing me with a vital first-hand perspective of the long-standing, productive and collaborative working relationship FDA maintains with our regulatory counterparts in this wonderful country. I’ve blogged many times about the importance of adapting to our rapidly changing world—one in which the medical products we use and the foods we eat are increasingly produced in countries other than our own. Perhaps nowhere is that dynamic more vivid than with our neighbors to the South. And nowhere provides a more profound example of how cooperation is essential to protect public health and realize the benefits of a vibrant trade relationship.

Today, Mexico is a major player in the global marketplace and, of course, one of the United States’ most important trade partners. In the U.S., nearly one-third of the FDA-regulated food products we eat come from Mexico. On the medical products side, Mexico is the 2nd leading exporter of medical devices to the U.S.—the vast majority of which are lower risk devices such as surgical drapes, wheelchair components, and non-invasive tubing.

The foundation of successful cooperation is forging real relationships with our regulatory counterparts and our key stakeholders including the industries we regulate. FDA’s office in Mexico City—one of three in the Latin America region—has been a critical source of support for many of our collaborative activities since we opened its doors some four years ago. And this week my colleagues and I have had the opportunity to have fruitful meetings with the leaders of the Mexican Ministry of Health and the two regulatory agencies with whom work so closely: COFEPRIS (the Federal Commission for the Protection from Sanitary Risks) and SENASICA (the National Service for Agroalimentary Public Health, Safety and Quality).

We’ve discussed our respective strategies to address our nations’ most critical public health issues like obesity and nutrition, and the important ways in which we share information and align our regulatory approaches. For example, our partners in Mexico have such confidence in FDA’s premarket review system of medical products that COFEPRIS issues agreements with companies — agreements that recognize FDA approvals and grant drug and device companies “fast track” pathway to make their products available to patients dramatically more quickly.

Margaret Hamburg and Mike Taylor at mushroom farm

FDA Commissioner Margaret A. Hamburg, M.D. (foreground), and Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine (left), visit a mushroom farm in Mexico

We also held two interactive roundtable discussions with members of the medical products and food industries in which we had lively exchanges about key issues such as how quality manufacturing is not only good for public health, but good for business. And yesterday I got a close up view on that critical concept with a visit to the Monteblanco facility of Hongos de Mexico, S.A. de C.V., one of Mexico’s largest producer of mushrooms – located in the Toluca valley just a 90 minute drive from downtown Mexico City. Hongos de Mexico is a company that FDA has routinely visited and inspected given Monteblanco produces a staggering 60,000 pounds of mushrooms each day for consumption within Mexico and export to the U.S. and other countries. In addition to being an enlightening education on the process of growing and packing mushrooms, our visit to the Monteblanco facility was a living example of the critical role the private sector plays to ensure the safety of products for consumers in the U.S. and around the world.

Today is the final day of our jam-packed visit to Mexico and I’m thrilled that we will be signing a Produce Safety Partnership Statement of Intent, which is just the latest example of the successful collaboration to reduce the increased risk of foodborne illnesses that naturally comes with a more globalized market. The partnership will support our work to implement preventive practices and verification measures to ensure the safety of fresh and minimally produced fruits and vegetables.

At the end of the day, our trip to Mexico has shined a bright light on how important it is to continue to explore new ways to fulfill the mission that we share with our regulators around the world—to protect and promote public health. Our partnership with Mexico serves as a model not only as it relates to improving the health and well-being of consumers but also to promote innovation and economic growth.

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

Getting it Right on Spent Grains

By: Michael R. Taylor

Since the March 31 close of the comment period on FDA’s proposed animal feed rule, we’ve received a lot of questions and comments about so-called spent grains. Spent grains are by-products of alcoholic beverage brewing and distilling that are very commonly used as animal feed.

Michael TaylorTo add to the picture, spent brewer and distiller grains are just a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. One industry estimate is that 70 percent of human food by-product becomes food for animals.

We’ve heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we’re not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.

We also believe the potential for any animal safety hazard to result from this practice is minimal, provided the food manufacturer takes common sense steps to minimize the possibility of glass, motor oil or other similar hazards being inadvertently introduced, such as if scraps for animal feed were held in the same dumpster used for floor sweepings and industrial waste.

We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.

We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.

Our door at FDA has been wide open to stakeholders at every step of the FSMA process. We have learned a lot through active, two-way dialogue with those who have concerns about what we propose or ideas about how we can achieve our food safety goals in the most practical way. We hope and fully expect that dialogue to continue.

Michael R. Taylor is FDA’s Deputy Commissioner for 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

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

 

Better Process Control Schools Around the World

By: Irene Chan

When you open a can of creamed corn soup, your expectation is that you can consume it without fear of getting sick. We rely on commercially sterile foods, such as canned foods and other shelf-stable vacuum packaged foods, for everyday meals, as well as for emergency situations, such as natural disasters. In all of these situations, the safety of food is vital. The airtight, low-acid environment of many commercially-sterile foods is a prime target for the growth of bacteria that can produce a lethal toxin that causes botulism.

Irene ChanFortunately, since FDA established low-acid canned food (LACF) and acidified food (AF) regulations in the 1970’s, the commercial processing of commercially sterile foods in the United States has become much safer. One of FDA’s requirements is that, with few exceptions, manufacturing supervisors at canneries must have taken an appropriate training course to understand how to make a safe commercially-sterile product. FDA must approve these so-called Better Process Control Schools (BPCS), which numerous large universities throughout the United States offer. These courses provide essential information about how to effectively control the risks associated with the manufacturing of commercially-sterile foods, and how to comply with U.S. law.

With the increasing globalization of the food supply, FDA has recognized that the need for BPCS training has gone beyond our shores. And until recently, it was a challenge for foreign manufacturers to send persons to attend BPCS in the United States because of travel and language barriers. But through FDA’s foreign offices, we have supported local universities throughout the world with the capability to host approved BPCS training courses right where they are needed.

China, where there are several hundred establishments registered with FDA to export canned foods to the United States, is a prime example of a robust food export market. In September 2011, through collaboration between FDA’s China Office and experts in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the first-ever, locally sponsored BPCS course in China was conducted at China Ocean University in Qingdao, Shandong Province. Attendees were able to obtain the content of the course in Mandarin Chinese from local food technology professors, while an FDA technical advisor was available for questions. This June, the university held its second course, with eager attendees coming from mainland China as well as Taiwan.

Closer to home, the Latin American region has established itself as the pantry for the United States, supplying a myriad of food products throughout the year. There are hundreds of food manufacturers in the region that would greatly benefit from the opportunity to send supervisors to a local, approved BPCS. The Latin America Office has identified three universities as having the knowledge base and infrastructure to conduct BPCS courses: Costa Rica’s Center for Food Technology Research (CITA), Guatemala’s Del Valle University, and Peru’s National Agrarian University- La Molina.  In addition, FDA’s Latin America Office worked with the Inter-American Developmental Bank to obtain funding to provide the approved course materials for the universities in Guatemala and Peru to conduct their own BPCS. These universities will soon provide these courses at a low cost, with capable instructors who speak the local language and understand the local realities of the industry. In Peru, the university recently completed their first BPCS on August 17th, 2012. Representatives from FDA’s Latin America office, FDA’s Office of Regulatory Affairs, and CFSAN were present to answer questions and assist with the delivery of the class. In Costa Rica, CITA has scheduled their first BPCS for August 27-31, 2012, and expects attendees from the Caribbean and Central America region.  These are pilot programs, and we have already heard from other countries and institutions that want to participate in similar efforts.

Indian manufacturers produce hundreds of different varieties of vacuum packed ready-to-eat dinner entrees that are imported into the United States. Before 2011, no in-country BPCS was available for these manufacturers. In March 2011, local faculty at Bhaskaracharya College of Applied Sciences in New Delhi taught a BPCS course for the first time. The course cost each student only about $200—this sum paid for instruction, catering for meals and course materials. Students came from throughout India to attend the course.  A FDA technical advisor’s participation in the course allowed students to ask questions about process filings and engage in technical discussions with FDA. This year, the college held a second class in Sri Lanka for LACF and AF producers located in that country.  A third class is planned for later this year.

The FDA overseas offices are proud to have helped stand up these important training events in various parts of the world, and to support local universities as they develop the capacity to put on these courses. And the next time we open that pouch of vacuum-packed curry lentils, we will know that the effort to keep our food safe is truly global.

Irene Chan is the Deputy Country Director of FDA’s China Office. Edmundo Garcia, Jr., Assistant Regional Director for FDA’s Latin America Office, Daniel Geffin, Food Technologist in FDA’s Office of Food Safety, Food Process Evaluation Team, CFSAN, and Bruce Ross, Country Director of FDA’s India Office, contributed to this post.

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.