FDA’s FY 2016 Budget Request

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.FDA oversees products that represent more than 20 cents of every dollar that American consumers spend. Today, FDA presented its FY 2016 budget to Congress.This sensible budget request will help ensure that FDA can continue to fulfill its vast responsibilities to protect the public health, safety, and quality of life of the American public.

I want to share the cover letter that I wrote to Congress outlining some of our specific proposals.

 

Letter from the Commissioner

I am pleased to present the FY 2016 Food and Drug Administration (FDA) Budget.

FDA fulfills its important mission to promote and protect health in an increasingly complex and globalized world in many ways.  The scope of our work includes assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, vaccines and other biological products, and medical devices intended for human use are safe and effective; and regulating tobacco products.  We also play a lead role in protecting the public from electronic product radiation and assuring that cosmetics and dietary supplements are safe and properly labeled.  Finally, we have devoted – and will continue to devote – substantial resources to advancing the public health by helping to speed product innovations.

FDA’s responsibilities continue to expand as we work to fulfill the mandates of groundbreaking legislation passed in recent years, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the Food Safety Modernization Act (FSMA) of 2011, the FDA Safety and Innovation Act (FDASIA) of 2012, and the Drug Quality and Security Act of 2013.  Further, with so many FDA-regulated products manufactured in whole or in part outside of our borders, FDA is keenly focused on the complexities of regulating in a global marketplace.

In FY 2014, we took important steps to finalize a key set of proposed food safety rules; worked to improve the safety of compounded pharmaceutical products by conducting more than 90 inspections and implementing compounding legislation through proposed regulations, guidances, and other actions; published the “deeming rule” to extend FDA’s tobacco authority; and collaborated with federal, international, and industry partners to expedite the development and availability of medical products.  In addition, FDA has worked intensively to respond to the Ebola epidemic in West Africa by facilitating the development and availability of investigational diagnostics, therapeutics, and vaccines with the potential to help combat the epidemic.

FDA continues to seek new ways to obtain the most public health value for the federal dollar as we implement expanded authorities.  The products that FDA regulates are essential to public health, safety, and quality of life and represent over 20 cents of every consumer dollar spent on products in the United States.  Yet, in terms of our FDA budget, each American taxpayer contributes approximately $8 per year for the vast array of protections and services provided by FDA.

In FY 2016, we are requesting essential and timely resources to address critical food and medical product safety issues.  Mindful of the fiscal environment, we have identified targeted reductions where possible and identified long-term needs for additional user fees to balance budget authority growth.  FDA is requesting a total of $4.9 billion to support our various mandates to protect the American people.  This includes a $148 million budget authority increase to focus on the following:

  • delivering a farm-to-table system of prevention, including improved oversight of imported foods, through effectively implementing the final rules required by FSMA;
  • combating the growing threat of antibiotic resistance – in which drugs become less effective, or ineffective, against harmful bacteria;
  • promoting the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to “personalize” the diagnosis, treatment, and prevention of disease;
  • implementing key FDASIA requirements to improve medical product review and inspections;
  • addressing the safety of compounded drugs;
  • continuing implementation of new requirements for review of sunscreen ingredients under the Sunscreen Innovation Act; and
  • supporting modern facilities to provide the laboratories and office space needed to meet FDA’s expanded legislative mandates.

As a science-based regulatory agency with a public health mission, FDA plays a unique and essential role in promoting and protecting public health and safety.  We are committed to meeting the needs and expectations of the American people.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

Protecting Susceptible Populations from Chemical Contaminants in Food

By: Suzanne Fitzpatrick, Ph.D., DABT

Anyone who regularly eats food containing low levels of certain chemical contaminants may be adversely affected over time. But some groups of people are more sensitive to chemical contaminants than others and thus are more likely to be harmed by long-term exposure. We call these groups “susceptible populations.”

Suzanne FitzpatrickThe FDA’s charge to ensure the safety of the food supply is not limited to the protection of the general public. We also have a responsibility to protect susceptible populations.

Pregnant women, infants, young children, and older adults have long been recognized as susceptible populations by the scientific community. In addition, people with cancer, diabetes, HIV/AIDS and transplant recipients may have weakened immune systems and thus may also be more vulnerable. In short, these groups may be at greater risk from a given amount of a chemical contaminant because of their age, genetics, sex, or health status.

Committed to protect susceptible populations as best we can, the FDA convened its Food Advisory Committee on December 16-17, 2014 to help shape our efforts to understand when and how risk assessments should integrate concern for susceptible populations.

Conducted and used by regulators, risk assessments are one of the most objective and scientific ways to understand the potential adverse health effects of chemical contaminants in the food we eat. They help regulators apply science in policy and decision-making. Think of them as a foundation for risk management, a bridge between data and decisions.

At times, however, susceptible populations may require special consideration. They may even warrant separate risk assessments under certain circumstances. If we evaluate their risk with the same broad brush that we apply to the general population, we might miss certain realities. In pregnant women, for example, metals like cadmium, lead and arsenic can cross the placenta and may harm the fetus while its neurological and immune systems are in their earliest stages of development. Similarly, senior citizens may have nutritional deficiencies or cardiovascular problems that make them more susceptible to certain contaminants.

We asked difficult questions of the Food Advisory Committee. To paraphrase a few, we asked what factors the FDA should use to define a susceptible population, what data and level of confidence are needed to initiate a separate assessment for any given susceptible population, and whether there are subpopulations or life stages of particular concern. We also asked several technical questions.

My colleagues and I hope to make meaningful inroads toward better understanding the risks faced by susceptible populations through our risk assessments, in part with the committee’s help. We are confident that we are on the right track. In fact, our effort aligns with a recent report by the National Academy of Sciences (on inorganic arsenic), which suggests that, depending on the chemical, separate risk assessments may be warranted for certain susceptible populations.

We will study the committee’s advice to consider how we can best incorporate susceptible populations into our risk assessments. Ultimately, we know that it might not always make sense to take a “one-size-fits-all” approach when it comes to food safety.

Suzanne Fitzpatrick, Ph.D., DABT, is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition.

Food Safety Together

By: Mary Lou Valdez and Julie Moss Ph.D., R.D.

In early December, we represented the FDA in Cape Town, South Africa, at the third annual conference of the Global Food Safety Partnership (GFSP). FDA has been a strong supporter of the GFSP since 2012, when it was launched by the World Bank and Commissioner Margaret A. Hamburg, M.D., gave the keynote address at the first conference. FDA provides the Partnership with financial support and technical expertise.

Julie Moss (left) and Mary Lou Valdez (right)

Julie Moss (left) and Mary Lou Valdez (right)

The World Bank is uniquely positioned to facilitate the GFSP and create a “big tent” where all parties in the global supply chain can work together to help ensure that all food products are safe for consumers. While government agencies like FDA develop standards and regulations, and provide regulatory oversight, it is the food industry, not the government, which produces safe food for consumers. To be successful in improving global food safety, we need to create partnerships across nations and sectors. The unique role of GFSP is to enable and catalyze a clear strategic direction to strengthen food safety systems and supply chains globally in ways that can only be achieved or enhanced collectively.  The GFSP brings together government, industry, academic, consumer and international organizations, providing a unique and valuable opportunity for all of these parties to cooperate in new and creative ways to improve food safety. This requires coordination to focus our efforts and avoid duplicating each other’s work.

Attendees at the 2014 Food Safety Global Conference.

Attendees at the 2014 Food Safety Global Conference.

During the conference, we acknowledged progress on many ongoing food safety activities (e.g., needs assessment progress in Zambia and Good Aquaculture Practices training in Malaysia, among others) and we moved forward in building a framework for a long-term strategy to collectively support and sustain investment in food safety systems. Yet, there is still much work ahead for 2015, which will be a critical year for the GFSP, as we will further refine our strategy and look forward to making great strides in key GFSP initiatives, including work to strengthen food safety systems in China and Zambia. Success in protecting the safety of the world’s food requires a new paradigm with new partnerships across nations and sectors. Moving forward, we intend to work to expand and promote this valuable partnership in the coming year to continue to strengthen the global food safety net for all consumers.

At FDA, we recognize that today’s food supply chain is global, complex, and interconnected. Because the U.S. imports half of its fresh fruits and 80 percent of its seafood, our efforts to protect the U.S. food supply must be global, and we must build strong partnerships to create a world-wide product safety net to protect public health. GFSP is an example of our ongoing efforts to build partnerships as we aim to prevent unsafe products from entering the market, no matter where the products come from or where they are consumed.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Together: A Food Safe America

By: Michael R. Taylor

I recently had the pleasure of speaking at the Consumer Food Safety Education Conference convened by the Partnership for Food Safety Education (PFSE). The conference brought together food safety educators from across the country – people in state and local health departments, universities, extension services, and food businesses who are working every day on the front line, with consumers, to reduce food safety risks by improving consumer food handling practices.

Michael Taylor

Michael Taylor

The theme of the conference was “Together: A Food Safe America” – a theme that captures so well the sense of community, high purpose and energy that were present so abundantly at the conference. I shared the podium with two good friends and colleagues representing key FDA partners on food safety – USDA’s Acting Under Secretary for Food Safety Brian Ronholm, and Joe Corby, the Executive Director of the Association of Food and Drug Officials, which represents state and local food safety officials.

We regulators have a responsibility, through our oversight of the food industry, to do everything we reasonably can to make sure that the foods consumers bring into their homes are as safe as they can be. We are doing this by building into our food safety standards and compliance programs modern concepts and techniques for preventing the contamination that can make people sick.

Under the FDA Food Safety Modernization Act (FSMA), we at FDA have a new mandate to build a farm-to-table system of prevention, encompassing work that must be done to make food safe at four major stages of the commercial food system. These pillars of prevention include:

  • Production of produce on the farm,
  • Practices in food processing and storage facilities,
  • Transportation of food, and
  • Practices in grocery stores and restaurants.

But there’s a fifth pillar of prevention, and that’s the consumer. We all know that, even with the best of efforts by commercial food producers and handlers, consumers still must play a crucial role in preventing the introduction and spread of contamination – by keeping their hands and food surfaces clean, by keeping raw meat and produce separate, and by being sure to cook food to proper temperatures and chill food through prompt refrigeration.

It seems like common sense – and the basic ideas are – but food safety educators know that it’s far from simple to provide consumers the information, tools, and motivation they need to turn common sense into sustained behavior change. But they are out there, every day, doing the hard work.

We in government and the food industry need to better support our food safety educators.  FDA, USDA, and the Centers for Disease Control and Prevention (CDC) do some good work on food safety education. For example, at FDA, our current programs include targeting groups and individuals who are especially vulnerable to foodborne illness and partnering with the National Science Teachers Association to incorporate food safety into the science curriculum at the middle and high school levels. But there is more we can do to support food safety educators at the front line, in their daily work with consumers in clinics, in schools and in communities – where most of the food safety education, and all of the behavior change, takes place.

At FDA, we will be building food safety education into our risk-based priority setting paradigm, which means documenting better the contribution that education makes to reducing risk, evaluating what works to sustainably improve consumer practices, and targeting resources where they will make a real difference. Federal food safety agencies – and their finite resources – are overwhelmingly focused on the congressional mandate to prevent hazards arising from the commercial supply chain, which makes sense: that’s what we regulate. But, backed up by the right analysis, we can effectively target and increase our investment in consumer education in ways that will make a real difference for public health.

But the federal government can only do so much. And that’s where PFSE comes in. The Partnership brings together government, industry and consumer leaders to pool their expertise, share their perspectives, and collaborate on the hard work of food safety education. I applaud and thank the consumer groups, food companies, and trade and professional associations that are contributing their time, creative energy and resources to the work of the Partnership. And I salute the PFSE’s Executive Director Shelley Feist for her leadership and her sustained commitment to food safety and consumer education.

Working hard, and working together, we can have a Food Safe America.

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

Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine

By Michael M. Landa

On Tuesday, Dec. 9, my colleagues and I met with the parents of two young men who died after using powdered pure caffeine.

Michael M. LandaLogan James Stiner, an 18-year-old high school senior, prom king and athlete just days away from graduation, died on May 27, 2014 at his Ohio home after taking powdered pure caffeine. On June 24, 24-year-old James Wade Sweatt of Georgia, newly married and a recent graduate of the University of Alabama at Birmingham, died after being in a coma caused by his use of powdered pure caffeine.

Their parents spoke with us about how both young men were healthy, intelligent, and careful about what they put in their bodies.

They learned, and shared with us, that Logan and Wade both thought this form of caffeine would be a safe way to get an energy boost. Both were able to obtain it cheaply and easily. Wade had sought out the product as a way to avoid the added sugar and sodium associated with soda or energy drinks. He had even downloaded a conversion chart to try to calculate the right dose to take.

Katie and Dennis Stiner, and Julie and James Sweatt, came to the FDA in hopes of sparing other families this terrible loss.

We share that goal. That’s why, after learning of Logan’s death, the FDA posted a consumer advisory warning of the dangers of consuming powdered pure caffeine.  Symptoms of caffeine overdose include rapid or erratic heartbeat and seizures.

We are working right now on our next steps. In the meantime, I cannot say strongly enough how important it is to avoid using powdered pure caffeine. The people most drawn to it are our children, teenagers, and young adults, especially students who want to work longer to study, athletes who want to improve their performance, and others who want to lose weight.

The powdered pure caffeine that the Stiners and Sweatts brought to show us—readily available for purchase online—was packaged in the same way as protein powder and marketed as a source of energy, rather than a stimulant. The reality is that these products are 100 percent caffeine, with a single teaspoon roughly the equivalent to the amount in 25 cups of coffee. Pure caffeine is a powerful stimulant and even very small amounts may cause an accidental overdose.

Our hearts go out to the Stiner and Sweatt families, and we appreciate their efforts to protect others from harm. As regulators, and parents ourselves, we take this threat to public health very seriously and are committed to protecting young people like Logan and Wade, and all consumers, from the dangers inherent in the use of powdered pure caffeine.

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

Regulators Caught in the Act of Protecting Public Health

By: Melinda K. Plaisier and Michael M. Landa

We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live insects.

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

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

Their work, they knew, would prevent that shipment from reaching consumers, and they were justifiably proud.

“Government regulation” is a term often used with derision. During a recent tour to observe investigators in FDA’s Office of Regulatory Affairs (ORA), however, the value of regulations was clear. So were the dedication, skill, experience, physical stamina, and pride investigators bring to one of the major steps in enforcing regulations. Those qualities appeared again and again–at a blood bank inspection in Boston, a juice facility in Philadelphia, an egg farm in Iowa, a smoked seafood plant in Seattle and at the Miami warehouse.

About 91 percent of the seafood sold in the U.S. is imported; 80 percent of that comes through Miami. ORA inspector Michael McCoy offered us winter parkas for the inspection in the cold storage warehouse.

McCoy, a marine biologist, formerly specialized in aqua farming and helped develop the process for farming shrimp, including the means to artificially inseminate them. He has worked for ORA for seven years. When he walked in the warehouse to sample yellowfin tuna from Surinam, someone announced, “It’s the meticulous one.”

From an even colder section of the warehouse, forklifts carried tuna-filled boxes called coffins, due to their size and shape. McCoy randomly selected 18 fish and from each one cut, from fin to belly, a sample. Then he weighed each piece before bagging and freezing it in dry ice for shipping to ORA labs in Atlanta. Inspection procedures call for one-pound samples. McCoy weighs each piece, but it turns out that in every case, he’s cut exactly one pound.

Just 24 hours after McCoy cuts the samples, the shipper learns the fish passed all tests and can be put on a plane to its buyer in Jericho, New York.

Michael M. Landa

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

The cold warehouse inspection in Miami contrasts with the heat of an Iowa farm where 480,000 hens produce 144 million eggs yearly. FDA’s “Egg Rule,” or Title 21 of the Code of Federal Regulations, Part 118, is aimed at keeping the deadly bacteria Salmonella Enteritidis from the egg supply.

We travel deep into the countryside and up a long gravel road. In a “safe area,” we put on disposable Tyvek suits, including booties, hairnets, gloves and respirators. The suits are to ensure we don’t bring in anything to contaminate the area. At the door of the first of six henhouses, lead FDA investigator Katie Jo Close, a biologist, makes sure everyone walks through a box of powdered disinfectant—part of the farm’s biosecurity plan.

Sample collection requirements are exacting: for example, each swab for bacteria must be collected on a 4×4 inch, 12-ply gauze square that has been moistened with evaporated milk poured from a can whose lid has been disinfected with 70% ethanol. The protocols for where samples must be collected and how they are handled are even more exacting.

Before coming to ORA nearly six years ago, Close worked for a seed company, researching ways to make higher-yield, drought-resistant corn. Currently, in addition to inspecting egg farms, Close inspects facilities producing juice, canned goods and animal feed products, to name a few.

“I like the fact that each day is different,” Close says. “I feel like I’m protecting my family, my friends, my neighbors, everyone. I’m educating firms and farmers on how to follow the regulations that will prevent illness and death. I’m making a difference in people’s lives.”

From our desks in FDA headquarters, we see important work going on. Going into the field, though, is both humbling and inspiring. These men and women around the country, every day, are giving government regulations a good name.

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

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

Progress on FSMA: Getting Down to Implementation

By: Michael R. Taylor

This is the second of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

It appears to me that people all over the country are rolling up their sleeves and preparing to make FSMA a reality.

Michael Taylor

Michael Taylor

My team and I have just returned from visits to Georgia, North Carolina and Florida, states that are top producers of the fruits and vegetables that the world enjoys. We were there for listening sessions on the updates, or supplements, that FDA published in September to four proposed FSMA rules overseeing human and animal foods, both domestic and imported. Earlier in the month we visited California and Vermont for similar meetings.

When we visited states last year to discuss the FSMA rules that FDA originally proposed, beginning in January 2013, there were strong feelings that some aspects of our original proposals, such as the water quality standard, would be overly costly and not adequately adaptable to the range of production practices and conditions across the country. Farmers, manufacturers and importers want their foods to be safe, but they want rules that are as targeted as possible to risk and are practical to implement. We listened to their concerns, and we reviewed a wide range of written comments. They all formed the basis for the supplemental proposals that we issued in September, which have been well received.

During these most recent state visits, all of which were hosted by the heads of state agriculture departments, we heard continued support for FSMA and the need to implement it well, with mostly clarifying questions about the content of the rules. In fact, most of the discussion revolved around what has to be done once the rules take effect. We’re getting down to the nitty gritty of implementation.

Our day in Georgia began with breakfast with Commissioner of Agriculture Gary Black and Natalie Adan, director of the agriculture department’s Food Safety Division. The conversation centered on the importance of our partnerships with the states. FDA will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight.

There was also an appreciation, and a strong sense of priority, expressed by Commissioner Black and all of the state agriculture leaders, that the proposed FSMA rules will hold imported foods to the same standards as those produced in this country. That levels the playing field in the eyes of U.S. food producers, and it is also essential for food safety.

In all three Southern States, as well as in Vermont and California, there was some confusion about some of the specific terms of the proposed rules, especially the water quality and testing requirements. We are committed to providing clear guidance so that expectations are understood, as well as education, technical assistance and practical tools to facilitate compliance.

In North Carolina, we received a warm welcome from Agriculture Commissioner Steve Troxler who, as an elected official, has made food safety a campaign issue and a priority for his leadership and his department. In the listening session, Debbie Hamrick of the North Carolina Farm Bureau was very interested in how we will train our workforce to go out onto the farms, and how farmers will know how to meet the requirements. She offered to rent a bus and fill it with FDA officials and farmers to tour the area. Our reply: You’re on. She wants to work with us and we want to work with her.

We were also asked how we’re going to pay for all this and that brought up the critical issue of funding, which is a concern. It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017.

Florida was the final leg of this journey, which was fitting given Florida’s history of commitment to agriculture and food. Adam Putnam, the commissioner of agriculture, is a former U.S. congressman who had a leadership role in getting FSMA enacted. And Florida has been a pioneer in food safety, enacting seven years ago mandatory on-farm safety standards for the growing of tomatoes.

The listening session took place at the Gulf Coast Research and Education Center at the University of Florida’s Institute of Food and Agricultural Sciences. Driving there, we left the interstate highway to find ourselves suddenly in the midst of tomato fields, citrus groves and grazing cattle. We may think of Disney and spring training when we think of Florida, but agriculture is woven into the fabric of the state.

It was great to see Martha Rhodes Roberts, a long-time food safety leader in Florida, who moderated our listening session. As in Georgia and North Carolina, the Florida audience was a diverse mix of growers and people involved in various aspects of the food industry. The people we met in all three states appreciated both the changes we proposed in the supplemental rules and the continuing dialogue we are having on their implementation. They are ready now to get the job done.

I’d like to close with a reminder that the deadline for commenting on the four proposed supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

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

From Wariness to Welcome: Engaging New England on Food Safety

By: Michael R. Taylor

This is the first of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

What a difference a year makes.

In August last year, my team and I visited New England to talk about the rules proposed in 2013 to implement FSMA. We were met with skepticism and some genuine fear that our produce safety proposals did not take full account of local growing practices and would both disrupt traditional practices and deter innovation. These weren’t easy conversations, but they proved instrumental in FDA’s decision to propose—on Sept. 29, 2014—updates, or supplements, to four of the proposed FSMA rules overseeing human and animal foods, both domestic and imported. These proposals include significant changes in the produce safety proposal and related elements of the preventive controls rules for food facilities.

Michael Taylor

Michael Taylor

We weren’t quite sure what to expect when we flew to Vermont on Sunday, November 16, for a listening session the next day on the proposed supplemental rules. But the tenor of this visit was dramatically different, and very positive, beginning with the detour we took from our FSMA mission on Sunday to visit leading players in Vermont’s local food movement and artisanal cheese-making community.

Accompanied by Vermont Agriculture Secretary Chuck Ross, we first toured the Vermont Food Venture Center (VFVC) in Hardwick, a regional food hub that leases space to small food businesses, providing kitchen equipment, food storage and business consultations. The goal of this modern, well-equipped facility, as executive director Sarah Waring explained, is to strengthen Vermont’s local food network and agricultural economy.

We then toured Jasper Hill Farm in Greensboro, a renowned maker of artisanal cheeses.  We were welcomed by brothers Mateo and Andy Kehler, who have taken an innovative approach to making cheese, using both traditional methods and the latest technology. Their goal is to establish a network of local farms that supply the milk, with Jasper Hill aging and distributing the cheeses in an effort to support small dairy operations.

Our goal was to continue the dialogue we started this year with the cheese-making community to better understand, as food safety regulators, what goes into making artisanal cheeses. We learned a lot, tasted some great cheese, and left impressed by the community-oriented commitment at both VFVC and Jasper Hill Farm, and by their use of top-tier tools to strengthen Vermont’s local food system.

When we arrived back in Montpelier Sunday night, the setting was like something out of a postcard. This picturesque town, the nation’s smallest state capital, was dusted in the season’s first snow, which only accentuated its natural beauty and charm. We were happy to be there.

Monday morning we drove to the Vermont Law School in South Royalton for the FSMA listening session. This school, set in the rolling landscape of rural Vermont, is renowned for its commitment to sustainable environmental practices.

We saw familiar faces. Some had come to the meeting directly from their farm—through the snow. There were people from all over the Northeast—people who had participated in our series of listening sessions throughout New England in 2013. But this time, the response and dialogue were different. We heard acknowledgement and appreciation that we had addressed many of their concerns in our revised proposals by making the proposed rules more feasible, while still meeting our public health goals.

Much of the discussion focused on implementation of the rules, and, interestingly, some of the concerns echoed those we had heard in a November 6 listening session in Sacramento, CA, a place not only on the opposite side of the country but so different in its production systems. Many are finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered. We’ve always said that we wouldn’t take a “one size fits all” approach, which has contributed to making the rules more complicated. This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance.

Secretary Chuck Ross said early and often that we need to educate before and as we regulate. And he’s right. I am struck anew by the importance of our partnerships with state leaders. Vermont’s Ross and California Secretary of Food and Agriculture Karen Ross have been invaluable in helping us develop these rules, as they will continue to be as we move towards implementation.

We were grateful for the participation in the listening session by food safety advocates Lauren Bush and Gabrielle Meunier, who each spoke of the devastating effects of foodborne illnesses. Lauren almost died after eating a salad contaminated by E.coli in 2006 and Gabrielle’s young son fought, and recovered from, a Salmonella infection in 2008 after eating tainted peanut butter crackers. Their stories underscore the underlying reason for the effort that so many are making to implement FSMA—to keep people safe.

Some participants expressed the view that even though we decided to defer, pending further study, our decision on an appropriate interval between the application of raw manure and harvest, some kind of interval is needed to protect crops from pathogens. Some suggested that the 90 to 120-day intervals set forth by the U.S. Department of Agriculture’s National Organic Program be adopted as an interim measure.

Others inquired how the FSMA rules would affect them based on very individual scenarios. We asked them, and we’re asking everyone, to comment on the supplemental rules and include those scenarios for us to consider in drafting the final rules. We don’t want to create unintended harmful consequences.

The deadline for commenting on the four supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

Our Vermont trip was followed by state listening sessions in Georgia, North Carolina and Florida. I will be filing another FDA Voice blog on what we learned in those Southern states.

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

Reflecting on our steps to give Americans more informed food choices

By: Michael R. Taylor

Michael Taylor

Michael Taylor

Yesterday we released final rules to make it easier for Americans to make informed choices about the foods they buy at major chain restaurants and similar retail food establishments and from vending machines. Every day, for years to come, millions of consumers will see and benefit from ready access to calorie information they would otherwise lack.

In evaluating public health issues, FDA must often make difficult decisions and strike delicate balances. For an issue like menu labeling that touches so many people and must address the complexities of our modern food system, it is natural that there would be a wide range of views. So we appreciate the very positive reactions to our rules from the restaurant industry, the vending industry, consumer groups and public health experts, including the following:

We also know that, while our FDA team worked long and hard on these final rules, crafting them after carefully reviewing more than 1,000 comments on our original proposals, our work is not done. We will continue to work with all affected industries to answer questions about the rules and facilitate compliance in a practical way that can benefit the health of Americans for many years to come.

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

Providing Consumers More Information with Menu and Vending Labeling

By: Margaret A. Hamburg, M.D.

Increasingly, Americans are paying more attention to the foods we eat – the kinds, the quantities, the sources, and the individual ingredients that go into our meals. We know that when we have more information about the nutritional content of our food, we have the opportunity to make more informed choices.

Margaret Hamburg, M.D.Increased awareness about the choices we make certainly does not mean that we always eat what is healthy. But whether we choose to eat french fries or a tuna sandwich, those selections should reflect informed decision-making. That can only happen if the right information is available to make those choices. That’s why the two new rules FDA issued today on menu and vending machine labeling are so valuable for consumers.

Some states, localities and big restaurant chains are already doing their own forms of menu labeling. The new rules will require calorie information to be listed in a consistent, direct and accessible manner on menus in chain restaurants and similar retail food establishments, and on vending machines. Under the menu labeling rule, certain additional nutrition information will need to be available in writing when customers ask for it.

This is especially important, because about one third of the calories Americans eat and drink come from foods and beverages consumed away from home. In addition, research shows that when we eat out we often consume less nutritious foods and underestimate the number of calories we are taking in.

People can clearly benefit by knowing more, and the new FDA rules will help to do just that. They are not requirements about what people should eat or what restaurants should serve, but rather they will place more information in the customer’s hands so that they can make more informed choices for themselves and their families.

After considering more than 1,100 comments on the proposed versions of these rules, the rules create a consistent approach that will establish a level playing field for larger chain restaurants, while not being overly burdensome on small businesses or individual food establishments. The menu labeling rule applies to restaurants and similar retail food establishments only if they are part of a chain of 20 or more locations and satisfy other criteria.

Few decisions are as critical to our health and our daily lives as those involving the foods we eat. With these new rules on menu and vending machine labeling, Americans can be more certain that those choices are informed ones.

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