We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

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

Your Input is Bringing Change to Food Safety Rules

By: Michael R. Taylor

Michael R. TaylorYou spoke. We heard you.

We began 2013 with the proposal in January of two rules required by the FDA Food Safety Modernization Act: the Produce Safety Rule and Preventive Controls for Human Food. The former would set science-based standards for the produce industry while the latter would set safety requirements for food facilities.

We were determined from the beginning to be transparent in our processes and to engage all stakeholders in the work of crafting final regulations that would work across the broad spectrum of food-producing operations. An unparalleled outreach effort followed the proposal of these rules. My team and I traveled across the country and around the world to discuss these food-safety requirements with the people who would be most affected, including farms of varying types and sizes.

In our travels, we saw first-hand how everyone is committed to food safety.  We especially spent a lot of time talking to farmers, both those who are smaller and work the land their family has owned for generations, and those who oversee large, diverse operations. We have heard concerns that certain provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

And because of the input we received from farmers and the concerns they expressed about the impact of these rules on their lives and livelihood, we realized that significant changes must be made, while ensuring that the proposed rules remain consistent with our food safety goals.

For that reason, we are planning to revise language in the proposed rules affecting farmers and plan to publish it in the Federal Register for public comment by early summer. These include changes to sections covering water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities (such as a farm that has a food-processing operation), and procedures used to withdraw the qualified exemption to these requirements for certain farms. As we consider the comments we’ve received, we may decide to include other changes for public comment. We recognize that completing these rules is essential to protecting the public health and are committed to completing them as quickly as possible.

We always knew that the rules governing farmers would be complex, in part because of the incredible diversity in the size and nature of farming operations. The standards we set must accommodate that diversity and be feasible to implement.

In our efforts to get first-hand information about how these rules would work in the real world, we visited nearly 20 states, Europe and Mexico; toured small and large farms and met with farmers across the country; met with the Amish, organic producers and other groups deeply involved in farming; collaborated with officials from other federal and state public health agencies; and held many public meetings. We also met with coalitions of consumer groups and other stakeholders. Our outreach work has been focused on ensuring that we never took our eyes off the ultimate goal: Keeping the food that you and your family eat safe.

We believe that this decision to change  these proposed rules—in response to the careful consideration of many people involved in supplying our food—is critical to fulfilling our commitment to getting them right. I urge you to review these changes when they are ready and let us know what you think.

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.

FDA Scientists Showcase Cutting-Edge Research

By: David G. White, Ph.D.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In Vermont, Innovation Advances Local Food Systems

This is the seventh 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 and preventive controls rule that FDA is proposing as we implement the Food Safety and Modernization Act of 2011 (FSMA). 

By: Michael R. Taylor

Innovation was the theme of our day in Vermont on Wednesday, Aug. 21. We visited food operations that have developed enterprising ways to make the most of local produce markets and to expand the options available to both growers and entrepreneurs.

Mad River Food Hub owner Robin Morris, right, gives a tour of the food distribution and processing facility.

Our first stop was at the Mad River Food Hub in Waitsfield. Food hubs are all about connecting small farms with markets. They distribute locally grown foods in a way that would otherwise be difficult for the owner of a small farm.

Owner Robin Morris has also provided space for the use of small food businesses. People who want to make and sell food but do not have their own facility rent space at Mad River, using the industrial kitchen, cutting room and other facilities there.

It’s an enterprising way to provide a critical service and is a central part of the economic model of a local food system. Small-scale entrepreneurs can get a start in a licensed facility, while keeping costs at a manageable level.

Robin is doing this as a business but also as way to give back to the local food system, whose broad, community-oriented values he strongly embraces. Robin and his team are very tuned in to food safety and part of the service they provide is to support the use of safe practices. Even though many of these small businesses are likely to be exempt from certain requirements under the proposed FSMA rules, they know they also have to meet their customers’ food-safety expectations, and Robin’s team helps them do that.

Later we stopped at Intervale Food Hub in Burlington for a great discussion with Travis Marcotte, Sona Desai and others who are playing leading roles in the food hub movement nationally. In addition to deepening our knowledge of the diverse food hub business models in New England and elsewhere, we had a great lunch in their big old red barn.

Mike Taylor in the hydroponic greenhouse with David Hartshorn, right, owner of Hartshorn Farm.

One of the most interesting stops on our trip was at the Hartshorn Farm in Waitsfield, where owner David Hartshorn has invested in a hydroponic facility in addition to his traditional organic farming operation. Hydroponics is a kind of agriculture that does not use soil – the plants are grown in nutrient-enriched water.

With one hydroponic greenhouse so far, David has a very high-tech system for growing lettuce with amazing efficiency. He estimates that he can grow as much lettuce in one-quarter of a hydroponic acre as he could on 10 acres of farmland. And crops could be grown all year round this way. Such diversification can help keep growers on the land, with real potential for growth. And you’ve got to love David’s entrepreneurial spirit!

Unlike the conversations in Maine and New Hampshire earlier this week, the conversations in Vermont were less about concerns that the federal government will roll over local growers with its proposed regulations, although the “don’t squash the little guy” message still came through.

This day was more about showing FDA how Vermont is using smart and creative tools to make local growers and food producers successful. What they are doing here is truly impressive and bodes well for the robust and highly diverse local food systems in New England.

Our last stop on Aug. 22 was in Massachusetts, where we received a warm reception from a key state partner—Greg Watson, commissioner of the Massachusetts Department of Agricultural Resources.

Commissioner Watson and his colleagues joined us at a listening session at the Plainville Farm in Hadley. More than 150 growers and other stakeholders attended this session and expressed many of the concerns we’ve heard in the other states about the potential impact of these proposed regulations on their operations and on their very livelihood.

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

States Have Important Role in Building Food-Safety Partnerships

This is the sixth 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

 “Live Free or Die” has been New Hampshire’s state motto since 1945, and almost seven decades later it still represents the fiercely independent spirit of the people who live here.

At Dartmouth College, Mike Taylor talks at a listening session on FDA’s proposed food-safety rules.

Washington, D.C., is a company town in many ways and when you live and work there, it’s easy not to see how the federal government is perceived in communities where people are making their living from the land. There’s a wariness of what is seen as federal encroachment in matters that people believe should be handled at the local level.

We have known for some time how important the state role will be in implementing the provisions of the FDA Food Safety Modernization Act, and that was very apparent during our conversations in New Hampshire on Tuesday, Aug. 20. Everyone agrees that keeping the food supply safe is paramount, but accomplishing that — especially in the context of smaller scale, local food systems like we find in New England — will require teamwork that crosses federal and state boundaries.

We were fortunate to be joined in this visit to New Hampshire by Lorraine Merrill, commissioner of New Hampshire’s Department of Agriculture, Markets and Food, and Chuck Ross, secretary of Vermont’s Agency of Agriculture, Foods and Markets.

Lorraine and Chuck joined us in a listening session at Dartmouth College, where the concerns about federal involvement really jumped out. Locally oriented food communities are part of the social fabric and they want to stay that way. For the farmers and many consumers here, it’s all about looking a person in the eye and having confidence in the people you’re working with. Many participants in the listening session had studied the proposed rules carefully and asked important questions about how they would apply to highly-diversified local food systems. They challenged the rules’ practical and economic feasibility as proposed.

We also heard two compelling consumer voices about the importance of establishing modern standards to prevent foodborne illness: Lauren Bush, who suffered permanent damage to her health from spinach contaminated with E. coli O157:H7, and Gabrielle Meunier, whose son Christopher was hospitalized for seven days after eating Salmonella-contaminated peanut butter.

The challenge we must meet is to create food safety rules that reduce the risk of such terrible incidents, while being workable across the great diversity of American agriculture.

After the listening session, we visited the Co-Op Food Store in Lebanon. Founded in 1936 by Dartmouth College professors and their spouses, the Co-Op now boasts multiple stores and 30,000 members. There is a huge focus on local sources, with farmers’ photos on the walls. Many Co-Op employees have been trained in retail food safety, so the Co-Op clearly has a commitment to keeping their members safe. But it also identifies strongly with the farmers and wants to see them flourish. These go beyond business relationships; they are true partnerships.

At the Edgewater Farm in Plainfield, N.H., Mike Taylor, center, listens to Chuck Ross, secretary of the Vermont Agency of Agriculture, Foods and Markets. At right is farmer Pooh Sprague.

From there we went to the Edgewater Farm in Plainfield. Owners Pooh and Anne Sprague have the kind of diverse operation that you see a lot here. In addition to the family farm, there’s a very nice farm store in which the Spragues sell not only produce grown on their farm but flowers from their fabulous gardens. And while we were talking to Pooh, Anne was packing food for Community Supported Agriculture (CSA), in which subscribers share in the harvest.

Farmers often have complex business models in which they are producing food, selling it directly to consumers, and sometimes selling foods from other farms in their stores. They are legitimately concerned about how the proposed food safety rules will affect the various facets of their operations.

However, there are a lot of misconceptions about these proposals. For example, some farmers feel that the proposed rule would require them to put up fences to keep wildlife out of their fields. Fencing an entire farm would be a big expense and we heard anxiety about that. But fencing is not a requirement under the proposed Produce Safety Rule. Rather, they would have to monitor their fields for animal intrusion and separate out produce that is reasonably likely to have been contaminated.

It’s clear we’ve got a huge job ahead in communicating the nuts and bolts of the proposed food safety regulations, as well as implementing the rules that finally emerge. And that’s where the states will be so important.

It’s about working with people you know. State agriculture departments have food safety responsibilities, but they are also there to support the agricultural system. State agriculture and health officials are on the front line; they have relationships with growers and food producers. Their role includes enforcement, but also education and assistance. The food safety law mandates a federal-state partnership, but even if it didn’t, this just makes sense.

Dealing with people they know at the state level may allay some of the fears that growers and local food retailers have about new federal standards. We will work with Lorraine Merrill, Chuck Ross and other partners to figure out how various institutions at the local, state and federal levels can best collaborate to help the produce community move forward in a way that is good for consumers and feasible for farmers.

Keep watching this space. I will be filing another FDA Voice blog this week to keep you up to date on what I learn in my travels to Vermont and Massachusetts. 

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

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

On the Road with Mike Taylor, Day 4: Looking to the Future

This is the fourth 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 

We did a lot of talking and listening on the fourth day – Wednesday, Aug. 14 – of our tour of the Pacific Northwest. It was an excellent day, as my colleagues and I spent most of it in a six-hour listening session in Yakima, Wash.

Karen Killinger, an associate professor at Washington State University and the University of Idaho, speaks to growers, representatives of the food industry and others at a listening session to discuss proposed produce safety regulations. Seated on the panel are from left: Mike Taylor, Samir Assar, Erick Snellman and Travis Minor of FDA.

There were roughly 175 people at the listening session, many of whom are professionally involved in managing food safety on behalf of the area’s growers. The questions and issues they raised were often technical and very specific to key points in the proposed produce-safety regulations. It was an invigorating discussion.

In the late afternoon we visited more farmland and packing operations, as we did on the fifth and final day – Thursday, Aug. 15. On both days, we saw a diverse array of crops that include apples, pears, onions, peppers, cucumbers, tomatoes, melons, peaches and nectarines. We learned more about different irrigation systems and approaches to using water for both frost protection and to prevent scalding from exposure to the sun.

What we’re learning about the diversity of practices will help us get our produce rules right when we finalize them down the road; it also reminds us of the importance of taking a collaborative approach to implementing the rules. The rules will provide a common food-safety accountability, but as we implement the rules, we’ll need to maintain the spirit of partnership embodied in our Northwest experience.

The Pacific Northwest tour included a visit to the packing house at Valley Fruit in Wapato, Wash.

What this entails is working with our state partners, extension services and the produce industry to provide education, training and technical assistance to help farmers comply with the rules and, most importantly, move toward the shared goal of food safety and consumer confidence in food safety. As we did with the development of the proposed rules, implementation must take into account the diversity among growers and commodities, and the importance of working with the produce community as a whole.

Together, we’ll get this right and continue toward the long-term goal of keeping our produce safe for consumers in this country and around the world.

Keep watching this space. I will be filing more FDA Voice blogs next week to keep you up to date on what I learn in my travels to New England. 

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

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

On the Road with Mike Taylor, Day 3: Families and Partnerships

This is the third 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

As I visit farms in the Pacific Northwest this week, I have been truly moved by the passion that these farmers have for their work. This is not just a job to them – it’s their life. It’s their history, too, when the work is passed down from one generation to the next.

Kyle Mathison of Stemilt Growers in Wenatchee, WA, talks with Mike Taylor.

I am struck by the intensity of their desire to connect with me and with my FDA colleagues who have joined me in this tour of Idaho, Oregon and Washington to discuss provisions of the Produce Safety Rule that the agency proposed in January 2013. They want us to understand what they’re doing and why they’re doing it.

The landscape here is amazing — mountainous desert transformed into patchworks of fertile fields by the use of extensive irrigation systems. These systems move water through canals and reservoirs from the snowpack of the Cascade Mountains and deliver it to thousands of high desert farms. Irrigation makes agriculture possible here, which is good for the farmers, but also for consumers since some of the crops grown here would be hard to produce elsewhere. They thrive in this climate.

Cherries are one of those crops and we spent much of Tuesday, Aug. 13, visiting the multi-faceted operations of Stemilt Growers in Wenatchee, Wash. The Mathison family has farmed this land for five generations, since Thomas Mathison – an immigrant from Scotland – homesteaded 160 acres on Stemilt Hill.

We saw how the varieties of cherries are harvested and then drenched in cold water to remove the field heat. We visited the composting facility that sits on 18 acres, and the Stemilt packing house. We discussed the critical role of properly made compost as a source of nourishment for organic production, both in the region and nationally, and the importance of ensuring that food safety and organic standards are compatible. The Mathisons are clearly proud of what they term their “world famous” fruit.

Andy Bary, a Washington State University research scientist, Mike Taylor, Nathaniel Lewis with the Food Safety-Organic Program at the Washington State Department of Agriculture, and Gwendolyn Wyard of the Organic Trade Association examine the compost at Stemilt Growers.

From there we went to a different packing facility, Double Diamond Fruit in Quincy, Wash., that illustrates another theme of this trip – the importance of public-private partnerships with academia, state agriculture agencies and industry to develop and implement best practices.

Karen Killinger, Ph.D., an associate professor at Washington State University and the University of Idaho, has researched ways to reduce the risk of bacterial contamination in the produce packing process. She and her colleagues have worked with Double Diamond Fruit to implement a change in the packing line for apples that was shown to be more effective in killing bacteria.

As I travel this week, I am accompanied by some of the state leaders who will be full partners with FDA in implementing the produce rule and other safety regulations.

The presence of the three directors of the state agriculture departments – Donald “Bud” Hover (Washington), Katy Coba (Oregon) and Celia Gould (Idaho) – reminds me how much we value our state partners. They have a critical role in helping ensure that safety regulations crafted in Washington, D.C., are realistic as written and become a reality in the day-to-day operations of our food producers.

We have also been joined in our bus or in our cars – depending on which vehicles are working on any given day – by industry representatives who are providing input and perspective that will help us craft a final Produce Safety Rule that will be effective for food safety and practical for farmers.

FDA can’t do this alone. I don’t think that’s ever been clearer to me than it has been this week.

Keep watching this space. I will be filing more FDA Voice blogs to keep you up to date on what I’m learning here and in my travels to New England next week.

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

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

On the Road with Mike Taylor, Day 2: Frank Talk in Farm Country

By: Michael R. Taylor

We spent a second day in onion country on Monday, Aug. 12, visiting farms, food processing and packing companies, and an irrigation system. Idaho, Oregon and Washington are the top onion-producing states and we learned a lot about how onions are grown, harvested, packed and processed and how irrigation water is delivered to these high desert landscapes.

Paul Skeen, farmer and president of the Malheur County Onion Growers in Oregon, shows Mike Taylor how water is siphoned from the canal for furrow irrigation of bulb onions.

And then we listened to the concerns of farmers and others involved in the production of our foods who question whether certain standards in the Produce Safety Rule that FDA proposed in January 2013 will work in their production settings.

In this region, growers and other stakeholders in the produce industry are focused in particular on proposed regulations related to the quality of irrigation water. FDA is proposing numerical criteria for the level of E.coli in irrigation water, which has been shown to be a pathway for disease-causing bacteria.

Their reservations were plain to see when more than 150 of them came out to the Four Rivers Cultural Center in Ontario, Ore., on Monday for a listening session. In addition to my team at FDA, I was joined by Katy Coba and Celia Gould, directors respectively of the Department of Agriculture in Oregon and Idaho, and other state officials from all three states. There were also representatives from academia and the produce industry.

The room was so full that people were standing in the back; many of them had taken a break from their farming duties to attend. Person after person stepped up to speak at the open mike. These growers believe their crops are safe and are concerned about the impact the regulations would have on their businesses. Representatives of industry made the point that more data is needed before some of these regulations are put into effect.

And I was there to tell them all that they have FDA’s attention. Yes, their crops may have a low overall risk of contamination, and we are committed to issuing only those standards that are necessary for public health protection. But at the same time, we need to prevent illnesses from happening—that’s what the proposed Produce Safety Rule, mandated by the 2011 FDA Food Safety Modernization Act (FSMA), is all about.

Katy Coba (in red shirt), director of the Oregon Department of Agriculture talks to Mike Taylor and others visiting the Warm Springs Irrigation System and Owyhee Pipeline in southeastern Oregon.

We gave assurances that the proposed rule provides the opportunity for alternative ways to meet certain safety standards if those ways are scientifically proven to be effective. I hope we convinced them that we want to figure this out in a practical way—together. This trip is not just an exercise for us – we really want to learn what works on the ground-level. What we take away from this trip will have a big impact on the shape the regulations take.
FSMA is about food safety but it’s also about making sure consumers have access to a plentiful supply of fruits and vegetables, which are important for a healthy diet.  It’s about giving the public confidence in the safety of the food supply and having a stable, safe marketplace.

It was an emotional meeting and one filled with raw, honest discussions. There will be more sessions like this as we involve other stakeholders in the process of building practical, effective food-safety regulations.

As an aside, this trip has not been without a few small bumps. Our bus broke down Monday night—fortunately in a service station that had snacks—and now we’re caravanning by car. And when I’ve tried my hand at some farming tools, I’ve gotten mixed reviews. One farmer watching me try to install an irrigation siphon hose offered this sage advice: “Don’t quit your day job.”

Keep watching this space. I will be filing more FDA Voice blogs to keep you up to date on what I’m learning here and in my travels to New England next week.

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

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