FSMA Collaborative Training Forum: ‘Educate Before and While We Regulate’

By: Donald Kautter Jr. and Stephen Hughes

“We will educate before and while we regulate.”

That’s been a mantra for FDA as the rules that implement the FDA Food Safety Modernization Act (FSMA) have taken shape. Making sure that food producers understand the new requirements and have the knowledge they need to meet them is key to the success of this effort to prevent illnesses caused by domestic and imported foods.

However, FDA recognized early on that one size won’t fit all when it comes to training and that a variety of training options and delivery formats would be necessary to meet needs shaped by product, region, size, and other factors.

Enter the FSMA Collaborative Training Forum, convened in partnership by FDA and the U.S. Department of Agriculture. The forum is made up of the agencies, centers, associations, universities and others funded by FDA and USDA through cooperative agreements and grants to develop and deliver FSMA training. Communication between them is important to minimize overlap and improve coordination and efficiency.

The forum held its first meetings in April. Participants laid the groundwork for a vibrant collaboration that will support diverse food producers who are preparing to meet the FSMA standards.

photo of various produceThe diversity of the food producers is matched by the diverse community of training providers. The forum includes representatives of the public-private alliances funded primarily by FDA as a resource for industry: the Produce Safety, Food Safety Preventive Controls and Sprout Safety Alliances. It also includes the National Coordination Center (NCC) and four Regional Centers that were created in a partnership between FDA and USDA’s National Institute of Food and Agriculture to provide training opportunities for farmers, small food processors, and small produce merchant wholesalers.

In addition, the National Farmers Union Foundation and the University of Arkansas-Fayetteville, which entered into cooperative agreements with FDA to develop training curricula and delivery for local and tribal food producers, respectively, are among the training providers. The National Association of State Departments of Agriculture, which is engaged in a cooperative agreement with FDA to plan implementation of the produce safety rule, is also a member of the forum.

Last, but not least, there’s the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a partnership between the FDA and the University of Maryland that is focused on increasing global knowledge of effective food safety practices.

These first meetings focused on the new produce safety standards, which set science and risk-based requirements for the production of fruits and vegetables. All of these training programs are up and running, although they’re at different stages of development. But no matter where they are in this journey, they’re working together. The NCC, for example, has been coordinating with regional centers monthly and, through forum discussions, is now including those working with local and tribal food producers.

Everyone wants to measure success and to determine that they’re reaching the right audiences. Examining metrics and coordinating data will be a priority going forward so that all training providers have the same sense of what’s working and what isn’t.

Group members shared their experiences and knowledge in these first meetings. For example, a common experience has been that growers don’t use online training as much as other food producers. Lack of access to the internet or insufficient bandwidth to run the programs are the issues for some. We’ll reshape how the training is offered based on feedback as more data are collected.

This is just the beginning. There are plans to work with forum participants to post resource materials in a way that’s accessible to food producers around the world.

This is a great example of good governance – working in partnership and communicating across organizational boundaries to support those who will do the important work of strengthening our food safety system. The forum will meet every few months to help ensure that training programs meet the needs of those who must understand the new FSMA standards, no matter their size, nature, or location.

Donald Kautter Jr. is a Consumer Safety Officer in FDA’s Division of Plant Products and Beverages.

Stephen Hughes is a Team Leader in FDA’s Produce Safety Network.

They are the FDA co-leads of the FSMA Collaborative Training Forum, and partner closely with USDA to facilitate the forum.

Improving the Safety of Imported Foods Through Partnerships

By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M.

Susan Mayne

Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition

At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families.

In passing the FDA Food Safety Modernization Act (FSMA), Congress provided FDA with new authorities to help ensure that domestic food is as safe as possible and that imported food meets U.S. food safety standards. These new authorities to enhance the safety of imported foods take into account a variety of food safety partnerships, including several that FDA has had in place for years.

FDA recently held a two-day public hearing in which we received input from domestic and international food safety experts on how we can build on these strategic partnerships. The safety of imported foods is of great interest to all of us and of utmost concern to the American public. About 15 percent of the U.S. food supply is imported, including nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood. Those imports to the United States come from more than 200 countries and about 125,000 firms.

Camille Brewer

Camille Brewer, M.S., R.D., Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

What we took away from this hearing, a call to action that will guide us going forward, was a clear message from experts: There are a range of partnership tools that can enhance the safety of imported foods – from capacity building, to credible third party audits and certifications, to sophisticated forms of regulatory cooperation – and each should be used in a way that ensures it is appropriate for its intended purpose.

Countries that export food to the U.S. represent a continuum of food safety capacities and capabilities, and for that reason, one size doesn’t fit all when it comes to partnerships. Experts shared their experiences on how we can work with trading partners that need help in building their food safety systems, which, in turn, can help improve the safety of food imported into this country. Attendees discussed how capacity-building programs can be implemented, and how we can make these programs accessible and useful to various regions in the world.

At the other end of the spectrum: How does FDA leverage the knowledge and best practices of countries that have robust food safety systems, and that we have officially recognized as providing a comparable level of public health protection? So far, FDA has completed official recognition with three such countries – New Zealand, Canada and, just this week, Australia.

Don Prater

Donald Prater, D.V.M., Acting Assistant Commissioner for Food Safety Integration in FDA’s Office of Foods and Veterinary Medicine

Imported foods must be produced in a way that provides the same level of public health protection as that required of domestic food producers. Some of the questions we considered included: How will it be decided that a measure or procedure used in lieu of an FDA requirement provides the same health protection? How are countries ensuring parity in audits, inspections, verification, and overall oversight?

We also discussed whether, and how, federal agencies might leverage activities and resources with the private sector. How can we consider the role of private entities, such as companies that audit against various private food safety standards, in our oversight of imports?  And we considered the value of export control programs that are specific to certain commodities in terms of risk-based surveillance and planning.

The bottom line? We can use a variety of approaches to enhance the safety of imported food.

Overall, the hearing provided us with a rich tapestry of ideas, opportunities, and challenges that FDA will consider as we enhance our partnership activities. The key is understanding that one size doesn’t fit all.

Click here for the hearing webcast, transcript and additional background. 

Click here for ‘A Conversation with Donald Prater’ on advancing the safety of imported food.

Susan Mayne, Ph.D., is Director of FDA’s Center for Food Safety and Applied Nutrition

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

Donald Prater, D.V.M., is Acting Assistant Commissioner for Food Safety Integration in FDA’s Office of Foods and Veterinary Medicine

First Major FSMA Compliance Dates: Landmarks and Learning Experiences

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. That’s where we are today with the arrival of the first major compliance dates under the regulations developed by FDA to implement the FDA Food Safety Modernization Act (FSMA).

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

This is the day when larger businesses must comply with certain new standards under the preventive controls rules for human and animal food, two of the main rules developed to drive down the incidence of foodborne illnesses in our country. Larger human food facilities must meet preventive controls and modernized Current Good Manufacturing Practice requirements (CGMPs); larger animal food facilities must meet CGMPs. (The human and animal food rules have staggered compliance dates; animal food businesses have additional time to meet the preventive controls standards, as do smaller producers of human foods.)

The preventive controls rules were the first two of seven foundational FSMA rules to become final starting in September 2015. Human food facilities are required to have a food safety system in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent those hazards. The standards that animal food facilities must meet mark the first time that CGMPs have been broadly required for the safe production of animal food.

FSMA was signed into law in 2011 in the wake of mounting concerns by consumers and lawmakers about outbreaks of foodborne illness that kill thousands of people and animals every year. What followed was an unprecedented effort by FDA to involve the diverse landscape of food safety stakeholders, including growers, manufacturers, importers, distributors, consumer groups, and academic institutions, in the formulation of rules that are practical, flexible and effective for the food industry at home and abroad while protecting the public from contaminated food.

Howard Sklamberg

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Since FSMA was enacted in 2011, we have literally traveled the world to get input on the rules we proposed in 2013 and early 2014 to implement the law. FDA teams have been involved in approximately 600 engagements, including public meetings, webinars, listening sessions, farm tours, visits to manufacturing plants and extensive presentations and meetings with various stakeholder groups.

As a result of these conversations, we made significant changes in September 2014 to four of the FSMA proposed rules, including the preventive controls rules, to make them more feasible and, ultimately, more effective.

So what happens now? This is a new chapter for all of us. FDA is focusing on providing the support that companies need to comply with the new requirements with education, training and technical assistance. We will be looking at how facilities are working to comply with the new food-safety standards and protect consumers from unsafe food. Of course, our mandate is to protect public health and, when necessary, the agency will act swiftly to do so.

The conversations we had with stakeholders in creating the rules will continue as we move further into the implementation phase with the preventive controls and other rules. We will be sharing our thinking on how requirements should be met in guidance documents and asking for the public to continue to provide feedback. If necessary, changes will be made; aspects of the rules will be fine-tuned. This first wave of compliance dates is important to the entire spectrum of FSMA implementation; the lessons learned will be invaluable in the years ahead when smaller food facilities are held to the new standards.

So today, the rubber meets the road. But these compliance dates aren’t the beginning of the end of our work to make FSMA a reality. They’re the end of the beginning. The partnership that FDA has forged with food producers of all kinds, and with its state, local, tribal and international regulatory partners, will ultimately protect consumers for generations to come.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Charting a Path Forward on Food Safety, Nutrition and Animal Health

By: Stephen Ostroff, M.D., Susan Mayne, Ph.D., and Tracey Forfa, J.D.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is the FDA’s Deputy Commissioner for Foods and Veterinary Medicine

At FDA, we need to be prepared for the opportunities and challenges of today as well as those of tomorrow, and the FDA Foods and Veterinary Medicine Program’s new Strategic Plan for fiscal years 2016-2025 helps us to do just that.

Our new Strategic Plan makes it clear that we must have an overarching and risk-based approach that encompasses our broad portfolio of responsibilities. The plan organizes this work under four key goals: food safety, nutrition, animal health and organizational excellence.  Whether it’s chemical safety, dietary supplements, cosmetics, genetic engineering, nutrition labeling, antimicrobial resistance, review of animal drugs, or ensuring that we have the right technologies to identify hazards in the commodities we regulate—all of these issues impact the public health.  FDA is a public health agency first and foremost—and that is where our focus will be, using the core principle of science and tools such as regulation and guidance, research, and outreach and education to get us there. This fall, we’ll be issuing a broad implementation plan which will highlight specific actions under these four goals.

Susan Mayne

Susan Mayne, Ph.D., is Director of the FDA’s Center for Food Safety and Applied Nutrition

Over the past several years we’ve made a lot of progress in a number of key areas. We have been very focused on developing the implementation framework for the Food Safety Modernization Act (FSMA), an enormous undertaking to modernize our preventive approach to food safety, and that work will continue. At the same time, we’ve made great headway on nutrition, modernizing the Nutrition Facts label, publishing draft, voluntary targets for reducing sodium in various foods, and making a final determination that partially hydrogenated oils are no longer “generally recognized as safe.”  We’ve addressed the impact of animal agriculture on antimicrobial resistance by phasing out the use of medically important antimicrobials for production use and bringing remaining uses under the direction of veterinarians. And whole genome sequencing has helped us to identify the sources of foodborne illness outbreaks with speed and precision.

Tracey Forfa

Tracey Forfa, J.D., is Acting Director of the FDA’s Center for Veterinary Medicine

One important lesson we learned from our work on FSMA that we can apply moving forward is the importance of transparency and active stakeholder engagement. We transformed the way we do business, and it helped to make our work on FSMA successful. Sometimes, our perspectives may differ from those of our stakeholders, but the important thing is that we seek common areas of alignment to solve problems. We plan to use this approach more broadly.

It’s important that our plan stays current. It will be updated to reflect emerging science, technology, innovation, and trends in globalization. It will keep pace with emerging hazards and risks in the products we regulate. That is why we are establishing an open docket. Comments can be submitted at any time, so that we can consider them and update the plan at least every two years.

We encourage you to take a look at the plan and let us know what you think. We will have plenty of opportunity for discussion in the months and years to come as we work to improve the public health together.

Read the Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025

Stephen Ostroff, M.D., is the FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Susan Mayne, Ph.D., is Director of the FDA’s Center for Food Safety and Applied Nutrition

Tracey Forfa, J.D., is Acting Director of the FDA’s Center for Veterinary Medicine

Registration of Food Facilities: A Key Link in the Safety Chain

By: Erwin C. Miller, M.S.

The FDA’s mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since last fall to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to take science- and risk-based actions to help prevent the contamination that leads to foodborne illness.

Erwin MillerToday, the agency finalizes another rule to implement FSMA, one that updates the requirements for the registration of domestic and foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States, whether for people or for animals. Under the final rule, additional information will be required that will ultimately support the FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The registration rule also will affect establishments located on farms and “farm-operated businesses” by expanding the definition of a “retail food establishment,” which is not required to register as a food facility. The expansion of this definition would allow the inclusion of sales directly to consumers at roadside stands, farmers markets, Community Supported Agriculture (CSA) programs and other such direct-to-consumer platforms in determining an establishment’s primary function and thus whether it meets the definition of a retail food establishment. Congress, through FSMA, directed FDA to amend this definition. (Under the final rule, a farm-operated business is a business managed by one or more farms and that conducts manufacturing/processing not on the farm.)

The registration of food facilities has long been considered a key component of food safety. The September 2001 terrorist attacks highlighted the need to enhance the security of the infrastructure of the United States, including the food supply. Congress responded by enacting the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (called the Bioterrorism Act). This law directed the FDA to require food facilities that manufacture, process, pack, or hold food for consumption in the United States to register with the agency.

Nine years later, FSMA required that facilities renew their registrations biennially, among other new registration requirements. The biennial renewal requirement was effective upon enactment of FSMA, and the final rule codifies this and other registration requirements. The final registration rule also requires some new information, including the type of activity conducted for each category of food product and certain email address information to help expedite communication between the facilities and the agency. In addition, the final rule establishes mandatory electronic registration (with the availability of a waiver process) beginning January 4, 2020.

Facilities also will be required to provide a unique facility identifier (UFI) number as part of the registration process. This will allow the FDA to verify the facility-specific address associated with the UFI and help the agency ensure the accuracy of the registration database in a way that has not been possible under the current system. FDA plans to issue a guidance document to support compliance with the UFI requirement. Food facilities will be required to provide a UFI beginning October 1, 2020.

Together, the requirements in the final rule will be invaluable in providing the FDA with more accurate information about facility locations and information about the activities within facilities—thus aiding investigators in responding to foodborne illness outbreaks or earthquakes, floods, or other disasters. The final rule will also help the agency identify high-risk facilities and ensure that personnel with the proper training are dispatched to conduct an inspection.

While there is no fee for registration, some in the food industry submitted comments stating that certain aspects of the proposed rule would be too burdensome. In response to these comments, the agency has postponed the requirement for mandatory electronic registrations and the submission of a UFI to 2020 to ensure that facilities have ample time to comply.

The next biennial registration period will be October 1 through December 31, 2016. The FDA is committed to working with the food industry to facilitate implementation of this rule and address any questions that arise.

Erwin C. Miller, M.S., is the Chief for the Data Systems Integration Branch in FDA’s Center for Food Safety and Applied Nutrition

Engagement and Collaborative Problem Solving: Two Ingredients for FSMA Success

By: Michael R. Taylor and Stephen Ostroff

As we’ve developed the rules needed to implement the FDA Food Safety Modernization Act, we’ve done a great deal of outreach to explain the new requirements and obtain feedback from stakeholders.

group touring Florida citrus grove

Tim Dooley (top of photo, center right), vice president of Blue Goose Growers in Fort Pierce, Florida, leads a tour of the company’s citrus groves.

We’ve got to continue doing this with the people working on the nation’s farms–since the produce safety rule issued in late 2015 primarily involves them.

This was a lesson learned in our recent trip to southern Florida, where we toured citrus farmlands and took part in a public meeting on the final FSMA rules at the University of Florida’s Institute of Food and Agricultural Sciences (UF/IFAS). We found that growers want to meet the new standards in the produce safety rule but need greater clarity and understanding about how the rule can be applied to their specific farm setting.

Florida farmers are under a lot of pressure that has nothing to do with the FSMA rules. The citrus groves there have been hard hit in recent years by a disease called citrus greening that results in stunted, bitter, green fruit and drastically reduced harvests. The stark backdrop to our conversations is that these growers are fighting for survival–and every cost counts.

That makes it especially important that they, and all farmers covered by the produce rule, understand what will be required. And, just as important, what won’t be required.

For example, we talked to growers who have dozens of wells on their farms and are worried about the rule’s water testing requirements and associated costs. But in many cases, only a fraction of those wells are used to apply water in a way that is intended or likely to contact crops during growing, or for other uses that are  subject to the microbial water quality criteria in the produce rule.

Some growers pull surface water out of extensive canal systems where the water from any one canal may deliver water to many farmers. Other growers use seep irrigation systems in which the water seeps from a surface water source through the soil. The growers told us that the soil filters the water, which comes in contact with root vegetables like carrots, beets and radishes.

Their questions were: How are we covered by the produce safety rule and how do we achieve compliance? One of the growers produces beets and our answer to him was that beets are not covered because the produce rule exempts specific crops that FDA identified as rarely consumed raw, such as garden beets and sugar beets. We explained that water used in seep irrigation that contacts root crops covered by the rule does have to meet the applicable microbial standard. But farms have the option of establishing and using alternatives for certain agricultural water requirements if they have scientific evidence to support them.

Each region of the country has its own complexities, and Florida has a dramatically diverse landscape of crops, settings, and soils. The soil around Lake Okeechobee transitions from sandy at one end to densely dark muck at the other. Within the citrus industry, agricultural water can come from completely different sources, surface and ground water that have different testing requirements. We at FDA are constantly learning about the complexities that are part of everyday life for our nation’s food producers.

This trip highlighted how important it will be for us to be continually engaged at the local, state and federal levels in collaborative problem solving with growers and others in the food industry as we implement the FSMA rules.

We value the leadership of Florida Commissioner of Agriculture Adam Putnam, Deputy Commissioner Lisa Conti and others on their team. We have long been partners with Martha Roberts of UF/IFAS, an authority on food safety issues. And Florida itself is a pioneer in food safety, in 2008 establishing the first mandatory state regulatory program for produce with provisions for inspections and audits for tomato handling, production and packing.

Susan Turcovski, the director of FDA’s Florida District, and her team accompanied us on this visit. They are also on the front lines of implementation and their role will be critical in the months and years ahead. We were joined by Leanne Skelton, the U.S. Department of Agriculture’s liaison to FDA on FSMA issues, and spent time at USDA’s Horticultural Research Lab in Fort Pierce.

Education is an important part of our FSMA efforts. Another member of our group was Dr. Michelle Danyluk, one of the leads for the Southern Training, Education, Extension, Outreach, and Technical Assistance Center at the University of Florida. The center is one of four regional centers funded by USDA and FDA that will coordinate and implement FSMA-related training.

We’ve got our work cut out for us but every conversation brings us closer to the food safety system envisioned by FSMA that systematically takes steps to prevent the causes of foodborne illness. Working together, we’ll get there.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1, 2016.

A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan

By: Camille Brewer, M.S., R.D., and Sema Hashemi, M.S.

Our delegation of FDA experts traveled to Tokyo and Osaka in the first week of February to hold seminars on our new final rules under the FDA Food Safety Modernization Act (FSMA). These rules will require that foods exported to the United States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

FSMA outreach delegation and Ambassador Caroline Kennedy

The FSMA outreach delegation met with Ambassador Caroline Kennedy (center). The delegation members (from left) are: Sema Hashemi, Jess Paulson (from the U.S. Department of Agriculture), Jenny Scott, Samir Assar, Bruce Ross, Camille Brewer, Jeffrey Read, and Brian Pendleton.

We were delighted to see first-hand how receptive the Japanese government and industry have been, both in embracing FSMA’s principles and in bringing a more intense focus on preventive controls and supply chain management. Exports of agricultural, as well as fish and fishery products, to the United States are at a record high. The U.S. is Japan’s second highest export market, and key exports include rice, tea, soy products, confectionary and specialty products. The Japanese food industry is keenly interested in increasing exports to the U.S. and representatives expressed a strong commitment to fostering an understanding of and compliance with our food safety regulations. Throughout our visit, we were reminded of the important link between market growth and maintaining a strong reputation for safe exports.

Interest in FSMA is high. Public seminars in Tokyo and Osaka drew nearly 400 and 200 participants, respectively, our largest FSMA international outreach audiences to date. As a reference document for participants, the Japan External Trade Organization (JETRO) prepared a 315-page manual with translations of key FSMA regulations and FDA presentations for each participant.

JETRO, a government-related organization, has facilitated and delivered numerous informational programs for industry on FSMA since the passage of the law. During our outreach meeting, JETRO also delivered a one-hour FSMA overview, which effectively set the stage for more detailed FDA presentations that followed. These proactive efforts achieved a much greater understanding among participants and more productive interactions during our limited time together.

Our meetings with Japanese government colleagues in the Ministry of Agriculture, Forestry, and Fisheries (MAFF), as well as the Ministry of Health, Labour, and Welfare (MHLW), allowed us to take a step back and discuss ways in which the our governments can work collaboratively to promote food safety. It was clear to us that these ministries are very eager to collaborate closely with FDA to help ensure that Japan’s food exports to the U.S. meet FSMA’s high standards of safety for food production. We are looking forward to further discussions with our Japanese colleagues as FSMA implementation continues.

Our delegation received many thoughtful and detailed questions on how FSMA would apply to Japan’s food exports to the U.S., particularly to green tea and rice — as two foods particularly important to Japanese identity and tradition. Indeed, our delegation learned a great deal about the various steps in the production of both commodities. FDA and the Japanese ministries all committed to exchange more detailed information on traditional production methods for these commodities. They represent valuable case studies on how FSMA operates to ensure prevention-based oversight of the entire food supply chain, including those unique to a culture or community.

U.S. Ambassador to Japan Caroline Kennedy graciously set aside some time to discuss FSMA international outreach activities and food safety issues with our delegation. She was very pleased to hear of Japan’s detailed preparations for these FSMA seminars and the goodwill shown to FDA’s delegation. Ambassador Kennedy stressed the importance of the relationship between the United States and Japan in the area of agricultural trade, agreeing that future dialogue on FSMA would only serve to strengthen these close ties.

We leave Japan with many fond memories of the warmth and hospitality provided by our Japanese hosts. They honored us not only with their kindness but also with the meticulous preparation and education on FSMA that we could see had taken place in advance of our arrival. We move forward more confident than ever in Japan’s strong commitment to food safety and to ensuring that foods exported to the United States will be produced under the effective prevention-based systems that FSMA envisions for food supply chains around the world.

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

Sema Hashemi, M.S., is Director of the Office of Regional and Country Affairs within FDA’s Office of International Programs

FSMA Implementation: The Road Is Challenging, but the Company Is Extraordinary

By: Michael R. Taylor

As we begin 2016, it’s a good time to reflect on the extraordinary engagement we’ve had on food safety with the food-producing community and its continuing impact as we move forward to implement the FDA Food Safety Modernization Act (FSMA).

Michael R. TaylorIn August and September 2013, we took three important trips – to the Pacific Northwest, New England and Europe – to talk about the rules we had proposed earlier that year to implement FSMA.

What we learned on those trips made a huge impression, one that ultimately shaped more than just the rules. It had a profound effect on our understanding of the diverse global community of food producers, and opened our eyes to the food safety imperative that guides them.

More recently, we retraced our steps this November and December, making those journeys again to discuss the five FSMA rules that became final this fall — establishing preventive controls for human and animal food, setting produce safety standards, and strengthening oversight of imported foods.

First, some background. We had been traveling to farms since 2009, well before FSMA was signed into law in 2011, listening to and learning from farmers. The visits in 2013 were particularly important because FSMA had become law by then and we had specific proposals to discuss.

In the Pacific Northwest and New England, we focused on issues as different as the climate and geography of those regions. Growers who created lush farmland in the high desert regions of Idaho, Oregon and Washington using canal-fed irrigation systems were chiefly concerned about the agricultural water standards. In Vermont, Maine and New Hampshire, discussions centered on the impact of FDA’s plans on the local food movement and on farmers’ efforts to innovate and diversify.

There was a common theme, however: Growers have been understandably concerned about where we’re headed with these food safety regulations and how they will affect farms, especially those that have been in families for generations. So in 2013, with specifics on the table, there were some tough conversations about the merits of our proposals – and how they could be improved. In Europe, our discussions were primarily with our foreign regulatory counterparts, but also reflected uneasiness about the FSMA rules, particularly their impact on foreign trade.

The bottom line is that through these trips, our eyes were indeed opened to some realities. It became clear that we’d need to make changes for the regulations to work for the food industry while still protecting public health.

Fast forward to 2015. We saw familiar faces in our return to the Pacific Northwest and New England for public meetings in Portland, Oregon, on December 1, and in Brattleboro, Vermont, on December 14. These are people who were frank about their reservations and then rolled up their sleeves to work with us on finding solutions. And we did find solutions, building flexibility into the rules that give food producers and importers options and alternatives that still meet important safety criteria.

And in Europe, too, the conversation has turned to next steps. In early December we returned to Brussels and again met with our European Union regulatory counterparts. Europe has similar overarching food safety principles as the U.S. and the leaders we met want to leverage their resources and avoid duplication of effort. And we are looking into that now, beginning by comparing the public health protections in the European standards with those built into the FSMA rules.

The reception was enormously positive in all three places. We’re in a good place with the FSMA rules. Five of the seven rules we proposed have now been finalized, and we intend to publish final regulations on sanitary transportation and intentional adulteration in the spring. President Obama’s Fiscal Year 2016 budget request for FSMA implementation was close to fully funded, with FDA set to receive $104.5 million of the $109.5 million requested. This critical funding will enable us to maintain our momentum toward timely, comprehensive implementation.

We at FDA are gratified and grateful for what we’ve seen since we first took to the road in 2009. It’s clear that from the smallest farm to the halls of Congress, from local food centers to operations half-way around the world, there is a deep, shared commitment to produce safe food.

Without any doubt, there’s still a lot of hard work to be done, and we know some food producers are still apprehensive about the impact of our regulations on their livelihood. So, we will hit the road again beginning in January for more state and international meetings. We are committed to continuing the conversation and implementing FSMA in a practical way. Working together, we will create the modern food safety system envisioned by FSMA, one that makes every reasonable effort to prevent food safety problems and protect consumers and their families from foodborne illness.

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

FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance

By: Stephen M. Ostroff, M.D.

In my third and final post reflecting on FDA’s work to protect and promote public health in 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation.

Acting FDA Commissioner, Stephen Ostroff, M.D.Modernizing Food Safety

In a groundbreaking development, in 2015 FDA took several major steps to prevent foodborne illness by finalizing five rules that will implement the landmark FDA Food Safety Modernization Act (FSMA).

In September, we issued the first two final FSMA rules mandating modern, preventive practices in both human and animal food facilities. They will help establish a food safety system in which industry systematically implements measures we know are effective in preventing contamination.

In November, we took another step toward modernizing our food-safety system by issuing the final produce safety rule and two import safety rules. For the first time, these new rules establish enforceable science-based safety standards for the growing and harvesting of produce and make importers accountable for conducting risk-based verification to determine that imported food meets U.S. safety standards. In addition, through this rulemaking we established a program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities.

Together, these rules are designed to reduce the burden of foodborne illness in the United States. They support the broad goal of the law to proactively prevent problems across the entire food system, and to strengthen food safety coordination with other nations that produce the foods that Americans consume.

Strengthening Nutrition, Protecting Health

2015 also saw important progress in the area of nutrition. We finalized our determination that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in human food, a decision that will make an enormously positive difference in the health of Americans. We also are continuing to work to develop sodium reduction targets, which have the potential for major public health gains and cost savings to the health care system.

And late in 2014, we finalized two new rules requiring caloric information on restaurant menus and menu boards and on vending machines. These rules are designed to provide consumers with more information so they can make informed choices for themselves and their families, without placing an undue burden on small businesses or individual food establishments. We are working with industry to support implementation.

We also proposed additional changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give Americans updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods. This includes a revision that would establish a Daily Reference Value for added sugars and require the percent Daily Value on the label. There is strong evidence healthy dietary patterns of intake associated with a decreased risk of cardiovascular disease are characterized, in part, by lower intakes of sugar-sweetened foods and beverages.

Combating Antibiotic Resistance

Another area in which we saw great progress in 2015, thanks to collaborative efforts across our government and with our international partners, was in combating antibiotic resistance. If left unchecked, this growing problem threatens to turn back the clock on decades of progress in infectious disease control and medical discoveries, drive health care costs higher, and increase human disease and death.

Early in 2015, the White House released the National Action Plan for Combating Antibiotic-resistant Bacteria, a plan that that recognizes that humans and animals share the same environment – and the same microbes – and so we must address the use of antibiotics in both.

One of the central principles for slowing the development of resistance – in both humans and animals – is the judicious use of antibiotics. For decades medically-important antibiotics have been used not only to treat sick animals, but to promote growth in healthy ones. The FDA has already made significant progress developing policies to promote appropriate use of antibiotics in animal health. For instance, we issued the Veterinary Feed Directive (VFD) final rule, an important part of our overall strategy because it promotes judicious use of medically important antimicrobials in feed for food-producing animals by bringing the use of these drugs under veterinary supervision.

But a critical part of combating resistance is to know the changing patterns and use of antibiotics in farming and how these changes impact resistance patterns among foodborne pathogens associated with farm animals. We are strengthening our data collection under the National Antimicrobial Resistance Monitoring Program in several ways, and in September we held a Public Meeting with several other federal agencies on data collection on farms. This and other work will help us to develop a more comprehensive and science-based understanding of antimicrobial drug use and resistance in animal agriculture and help us to measure the impact of our regulatory actions.

While the problem of antimicrobial resistance is finally getting the attention it warrants, it will require an ongoing and sustained effort to overcome the decades of neglect that led to the current situation.

Regulating Tobacco Products

Our newest area of regulatory oversight is one of our busiest. It’s hard to believe it was more than 50 years ago that the Surgeon General issued the first Report on Smoking and Health. But it’s been just six years since Congress passed the Tobacco Control Act, which gave FDA the authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from their dangers.

We’ve already built a great deal on that foundation, creating our Center for Tobacco Products and establishing a framework for industry registration, product listing and submission of information on ingredients in tobacco products; implementing and enforcing a statutory ban on cigarettes with certain characterizing flavors; and restricting access and marketing of cigarettes and smokeless tobacco products to youth. We’ve also already begun to build a robust regulatory science program to conduct and fund science and research programs designed to help us better understand the risks associated with tobacco use.

After an extraordinary amount of study and research, and review of tens of thousands of public comments, FDA is preparing to publish the final rule to extend the agency’s authority over additional, unregulated tobacco products, such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco. Like everything we do at FDA, this policy will be based on a thorough scientific evaluation of how individual products in each category may affect public health.

And in 2015, we unveiled a dynamic public education campaign designed to prevent and reduce tobacco use among at-risk African Americans, Hispanics, and Asian American/Pacific Islander youth age 12 to 17. This promising effort flows from our “Real Cost” campaign launched in 2014, which I’m pleased to note, won a gold “Effie Award” for effectiveness in advertising in the Disease Awareness and Education category.

It’s been a fruitful and productive year at the FDA. I am proud of all we have accomplished in 2015 and look forward to our continued progress.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

A Mother’s Loss, an Advocate’s Example, Fuel Our Mission to Keep Foods Safe

By: Michael R. Taylor

For the many people in government, and elsewhere, who have been working on implementation of the FDA Food Safety Modernization Act (FSMA), this has been a week for reflection, celebration, and anticipation. I got to experience all three in the 24 hours I spent this week at the 2015 Food Safety Consortium in Schaumberg, Illinois.

Michael R. TaylorTuesday night I joined the many friends and supporters of the public health organization STOP Foodborne Illness in honoring Nancy Donley for her 22 years of ‎relentless advocacy for improving food safety. She is driven by the memory of her 6-year-old son Alex, who suffered greatly before he died in 1993 after eating a hamburger contaminated with E. coli O157:H7.

This was a time for reflection. Nancy and the many others in the STOP network who have shared their excruciating stories of pain and loss have made it simply unacceptable for those producing food to do anything less than their best to prevent these tragedies from happening.

Nancy, as much as any single person, has catalyzed fundamental change in our food safety culture toward making food safety a central business value for food companies and shifting government oversight toward a model that ensures accountability for minimizing contamination by pathogens.

Nancy has inspired me and many others to see food safety as the deeply personal, primary value it is, and to act accordingly.‎

STOP also honored Walmart’s Frank Yiannas as a STOP Food Safety Hero for his pioneering work to define and instill food safety culture as a primary value in the food industry.

Reflections on Nancy’s and Frank’s contributions are the backdrop for a bit of celebration. Not because the culture change Nancy inspires and the food safety success we seek are complete — far from it. But we are on our way.

The three FSMA rules FDA issued last week to improve produce safety and strengthen oversight of imports, coupled with the preventive controls rules we finalized in September, create a powerful and comprehensive new framework for the prevention of foodborne illness. This framework will be completed next year with final rules on food transport and intentional adulteration. The rules are the product of enormous effort by teams of FDA experts and by the many government, industry and consumer partners whose input has been so important in shaping the rules.

At the conference Wednesday morning, I shared some of these reflections and the sense of celebration and gratitude we are experiencing at FDA. I got some positive nods and no push back, but it was clear that the food safety professionals at this gathering are focused on the future, anticipating the challenges and changes FSMA will bring.

So are we at FDA. We see challenges galore, but also a huge opportunity to fulfill a vision that Nancy and STOP rightfully insist be the guide for our food safety work and our food safety culture.

Food safety is a primary value for many in the food system. It must be so for all.

Science-based prevention is the organizing principle for many food production systems. It must be for all. 

And a spirit of common cause and collaboration on food safety, which has begun to take root in so many positive ways, must be the foundation for all the work ahead to successfully implement FSMA.

So, this week, let’s celebrate where we are as we anticipate and build the future.

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