FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.

FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

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

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 Taylor

Michael 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.

A Milestone in our Partnership with Mexico on Food Safety

En Español

By: Michael R. Taylor

We know that food safety is more a journey than a destination, but there are times when we can point to a major milestone along the road. Today, we reached such a milestone in our long-standing relationship with Mexico by signing a statement of intent to establish a new produce safety partnership.

signing ceremony in Mexico

Left to right: Michael R. Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine; Enrique Sánchez Cruz, Executive Director, SENASICA, Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration, and Mikel Arriola Peñalosa, Commissioner, COFEPRIS – at today’s signing ceremony.

Working with Mexico on food safety is a top priority. Mexico is one of the United States’ top trading partners, and much of the produce we eat is grown there, including produce that otherwise would be hard to find during the winter. And food safety modernization efforts are underway in both countries, providing an excellent opportunity for progress. In the U.S., we are implementing the Food Safety Modernization Act, and produce safety is a big part of that effort, while Mexico is implementing an amendment to its food safety laws that mandates standards for fresh produce, inspections, and surveillance and verification programs.

We have been working with the two food safety agencies in Mexico—SENASICA, the National Service for Agro-Alimentary Public Health, Safety and Quality, and COFEPRIS, the Federal Commission for the Protection from Sanitary Risks—for some time, and it has been a very rewarding relationship. Last fall, I had the pleasure of traveling to Mexico City to meet with Dr. Enrique Sanchez Cruz, director general of SENASICA, and Mikel Arriola, federal commissioner of COFEPRIS, who were both present for today’s signing ceremony. And in March of this year, I traveled to Tubac, Arizona, to meet with Mexican government officials and producers of fresh fruits and vegetables from both sides of the border to discuss how all of us—in both the public and private sectors—can do our part to meet high consumer expectations for food safety.

The statement of intent is just a two-page document, but it represents a strategy that is far-reaching and designed to achieve high rates of compliance with produce standards in each country. In the months and years to come, we will be working with Mexico to identify practices to prevent contamination during the growing, harvesting, packing, holding and transportation of fresh fruits and vegetables and verification measures to ensure these preventive practices are working. We will exchange information to better understand each other’s produce safety systems—and in fact, this sharing is already underway. We intend to develop culturally appropriate education and outreach materials to support industry compliance with produce safety standards, and we will work on enhancing our collaboration on laboratory activities and on outbreak response and traceback activities.  It’s an ambitious agenda, and that is the value of an inclusive partnership. We are engaging industry, commerce, agriculture, academia and consumers because everyone has a role in ensuring the safety of the food supply.

It is gratifying to see the progress we have made along the way—and even more gratifying to know that with the new produce safety partnership in place, fruits and vegetables will be safer for consumers on both sides of the border.

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

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 Taylor

Michael Taylor

To 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

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