Visit to West Coast Farmers and Processors Finds Shared Commitment to Food Safety

By: Stephen Ostroff, M.D.

Most people, even if they live in cities or suburbs, understand that there are many types of farms. But to really appreciate how different farms can be, you have to get out there and see it for yourself. By visiting farms in different parts of the country, you see first-hand the food safety challenges that are unique to a region. Farms are different sizes, grow a variety of crops and don’t follow the same growing and harvesting practices. There’s a varied amount of rainfall by region and season, and irrigation methods differ by crop and location. And so, while farmers confront some of the same issues, there can be real differences in the challenges they face.

What produce farmers and other food producers have in common is that they face new federal standards for the production of safe food. Seven foundational rules to implement the FDA Food Safety Modernization Act (FSMA) were finalized by May of this year. These include the produce safety rule, which establishes enforceable safety standards for the production and harvesting of most fruits and vegetables on farms in the United States and foreign farms that produce these commodities for the United States. They also include the preventive controls for human food rule, which establishes safety standards applicable to food facilities, including those that process fruits and vegetables.

I, along with my colleagues at FDA and state counterparts, visited the farmlands of the Pacific Northwest and California earlier this fall to get a sense of how growers, packers, processors and other stakeholders are getting ready to meet the new standards that apply to them. In September, we visited apple orchards and packing houses in Washington and berry growers in Oregon. We toured irrigation systems and met with stakeholders who included growers, water resources groups and tribal representatives.

FSMA West Coast Farm Tour

Parreira Almond Processing Company: Dr. Ostroff, left, and manager Paul Parreira Jr. at the almond hulling and shelling facility in Los Banos, CA.

In October, we visited stone fruit, table grape, citrus, and lettuce and strawberry fields in northern California. We toured an almond hulling and shelling operation in a visit coordinated by the Almond Alliance of California, and held a roundtable discussion about California’s water supply with farmers, representatives of industry associations and others. We visited a major processor of salad items. We finished the trip with an early-morning visit to the Golden Gate Produce Terminal in San Francisco, a trove of organic and conventional produce, as well as specialty and ethnic foods.

Produce farms have not been regulated like this before – it’s new territory for both the farming community and for FDA. We were asked many questions and received a great deal of feedback about the new regulations. But we found a strong commitment to providing consumers with safe fruits and vegetables and to moving forward in a collaborative fashion. For our part, I think it’s incumbent on FDA to protect public health without requiring a lot of unnecessary steps or measures that don’t achieve that goal.

These trips also highlighted the fact that that many food producers and industry associations have already invested a lot of time and effort in food safety measures. In some instances, what they have put in place goes beyond what is required under FSMA. In both trips, we saw farmers, other food producers, and industry associations stepping up to address past safety issues, including by developing their own on-farm standards and implementing audits to verify that those standards are met. Some developed treatment protocols and funded research to fill data gaps. These efforts will make it much easier to meet the new federal standards.

FSMA West Coast Farm Tour

Wenatchee (WA) Reclamation District: Manager Rick Smith, center, shows Dr. Ostroff, right, and colleagues an open irrigation canal system.

The big challenge for the growers in the drought-stricken Western states is water. The drought makes it difficult for growers to predict from month to month and season to season how much water will be available, where it will come from, and what it will cost. Therefore, many had questions regarding the produce safety rule’s water quality standards.

Our state regulatory partners in Washington, Oregon, Idaho and California brought members of the produce community together to meet us and discuss these issues. I am so grateful for their active involvement in making FSMA a success. Karen Ross, secretary of the California Department of Food and Agriculture, Lisa Hanson, interim director of the Oregon Department of Agriculture, Derek Sandison, director of the Washington State Department of Agriculture, and Pamela Juker, representing the director of the Idaho State Department of Agriculture, are strong voices for agriculture and food safety in the West, and we value their partnership and continued input. Both they and their staffs understand the farmers and have long-standing relationships with them. Through recently announced produce safety cooperative agreements with FDA, we will be partnering with each of these states and 38 others to implement the new produce safety rule.

We also had the opportunity to visit farms that have been in families for generations. These farmers take great pride in their work and are determined to keep their food safe but still have questions about how to they can comply with the new requirements. The take-home lesson for us was the need to provide adequate education and training and clear guidance that will help these farmers comply with FSMA. Farmers are looking for this and we’re making sure that we can fill these needs.

There was also a lot of discussion about making sure that the information we provide can be understood by people working on farms who are not native English speakers. There is a great deal of diversity in these regions, including the Hmong-American farmers of California’s Central Valley.

So there’s a lot of work ahead of us, and together we will roll up our sleeves to get it done. We went to see farmers and other food producers, and met a lot of talented people who grow and process the food we eat. We found an incredible diversity in the food that is produced, but a shared commitment to having the safest possible food supply.

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

FDA Cooperative Agreements with States to Advance Food Safety

By: Stephen Ostroff, M.D.

Today, the FDA is honoring an important commitment by awarding millions of dollars to the states that will help implement the new produce safety rule mandated by the FDA Food Safety Modernization Act (FSMA) to protect consumers from foodborne illness.

Stephen Ostroff, M.D.In FSMA, Congress envisioned a strong partnership between the FDA and the state agencies that have a greater understanding of the growing and harvesting practices in their areas. Many have longstanding relationships with farmers and produce associations.

To support this partnership, the FDA is awarding $21.8 million in cooperative agreements to 42 states in support of their work to help implement the new produce rule. These funds will provide states with the resources they need to develop a produce safety system, considering the specific and unique needs of their growers for education, outreach, and technical assistance.

The funding for each state is based on the estimated number of farms in the state that grow produce covered by the FSMA rule.  The goal is to provide resources that will enable the states to develop a multi-faceted, multi-year plan that includes an assessment of their produce safety landscape, including an evaluation of existing state authorities to implement a produce safety program and ways to develop a strong outreach and education program with growers.

The produce safety rule, which became final in November 2015, establishes science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables. State leaders were key partners as the produce provisions were being developed, providing valuable input on how to make the requirements as practical and flexible as possible for growers while still protecting public health.

The cooperative agreements build on a foundation laid long before the produce rule became final. Enacted in 2011, FSMA included several important provisions aimed at strengthening the National Integrated Food Safety System so that the more than 3,000 state, local, and tribal government agencies involved in food safety are fully integrated in FDA’s work to fulfill FSMA’s mandate.

We have been steadily building this system, and in our FY2017 budget request we have asked Congress for an additional $11.3 million in new budget authority to further support the development of state produce safety programs.

In 2014, the FDA entered into a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that brought together state partners to collaboratively plan implementation of the produce safety rule. The framework developed by NASDA will guide and inform states as they work on their own regulatory programs.

The cooperative agreements are part of a long-term strategy to strengthen this working partnership with the states. We’re in this together and the FDA will continue to support its state partners as we work to make the vision of a preventive and risk-based food safety system a reality.

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

FDA Is Preparing Guidances that Will Help Food Companies Prevent Foodborne Illness

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

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When we were drafting and seeking public comment on the rules that will implement the FDA Food Safety Modernization Act (FSMA), we promised that we would do whatever we could to help the regulated industry understand and meet the new requirements.

Susan Mayne

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

We meant what we said about “educating before and while we regulate,” since these new standards will ultimately transform the nation’s food safety system.

This month, we have taken important steps in fulfilling that promise with the release of three draft guidances that when finalized will help domestic and foreign food facilities meet the requirements of the preventive controls rules that became final in September 2015.

Those rules require hazard prevention practices in human and animal food processing, packing, and storage facilities. FSMA created the framework that holds manufacturers accountable for having a food safety plan, implementing it, verifying that it is working, and taking corrective action when it isn’t. Compliance dates are fast approaching for large food facilities. The human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and the animal food facilities must meet CGMPs by September 19, 2016. (The preventive controls rules have staggered compliance dates; smaller facilities have a year or more additional time to comply.)

One of the draft guidance documents covers ways to comply with the preventive controls requirements of the human food rule. Given the scope of that rule, we are prepared to issue only five draft chapters now, covering specific sections of the rule, but we will ultimately issue 14 chapters in all.

Tracey Forfa

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

These initial chapters cover basic information about establishing preventive controls in a human food facility. The first chapter is about the food safety plan in which a human food facility outlines how it has identified and evaluated its food safety hazards and how it will control hazards requiring preventive controls. The subsequent chapters provide direction on conducting a hazard analysis; understanding the biological, chemical and physical hazards that are commonly of concern; identifying and implementing the preventive controls that will significantly minimize or prevent hazards; and managing the preventive controls through such actions as monitoring, corrective actions and verification activities.

The other two draft guidances when finalized will help domestic and foreign facilities comply with key requirements in the Preventive Controls for Animal Food rule, which covers all animal food, including animal feed and pet food. One of those documents provides direction on ways to comply with the rule’s CGMP requirements, which are baseline food safety and sanitation standards for animal food facilities. This draft guidance also provides information on provisions related to the CGMP requirements, such as qualifications and training of personnel.

While CGMPs have long existed for the production of human food, this is the first time that most animal food producers will be subject to CGMPs. Concerns about incidents of food contamination that were sickening and killing pets were among the driving forces behind the enactment of FSMA.

The third draft guidance when finalized will help domestic and foreign food facilities whose by-products of human food production are used as animal food. Such by-products include grain products and vegetable pulp. They also include foods like potato chips, baked goods and pasta that are safe to eat but considered the wrong size, shape, color or texture.

Food producers required to meet food safety requirements for human foods had been concerned that they would have to meet a whole new set of requirements for such by-products. The draft guidance makes clear that the by-product will only be subject to limited CGMPs to protect it from contamination during holding and distribution, if the human food facility is subject to and in compliance with FDA’s human food CGMPs and all applicable human food safety requirements of the Federal Food, Drug, and Cosmetic Act and implementing regulations and is not further processing the by-products for use as animal food.

If the human food facility is further processing the by-products, the facility has a choice of complying with the requirements of either the human or animal food rule, as long as the food safety plan addresses how the facility will prevent or significantly minimize the hazards for the animal food that require a preventive control.

These draft guidances, and the others that we’re working on for the FSMA rules, will be further refined based on input we receive from the public. The comments we received on the proposed FSMA rules were important in helping us shape the final rules so we look forward to working with stakeholders in the same way on these documents.

Meeting the FSMA mandate involves cooperation between the FDA and the food industry. From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.

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

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

A Tale of 3 Countries: Applying FSMA Standards Globally

By: Stephen Ostroff, M.D., and Camille Brewer, M.S., R.D.

Over the past two months, we have been part of FDA delegations visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States with the FDA Food Safety Modernization Act (FSMA), each country we visited is addressing their national food safety objectives in unique and creative ways.  And each has committed to taking a strong role in supporting compliance with the new food safety regulations mandated by FSMA.

Stephen Ostroff, M.D.

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

Looking at how these nations are different – and how they are the same – opens a window on the challenges and opportunities presented by FSMA implementation on a global scale. The seven foundational FSMA rules are now final and they will have a profound effect on foreign food producers that want to export their products to the United States.

We visited Canada on May 10 and 11 for public meetings on FSMA in Toronto and Ottawa. Canada is modernizing its own food safety system under the Safe Foods for Canadians Act, which, like FSMA, places a strong emphasis on preventive controls. Our nations have a strong interest in achieving as much convergence as possible on food safety standards.

We had the opportunity to explain that the recently signed systems recognition arrangement with Canada does not create a “green lane” for foods shipped to the United States. Instead, it is a reciprocal regulatory cooperation tool that will foster greater risk-based targeting of resources and will foster cooperation in many areas, such as risk assessment and research. The systems recognition arrangement with Canada, signed on May 4, affirms that while our countries’ domestic food safety systems are not identical in all aspects, they currently do achieve a comparable degree of food safety protection.

In addition, considerable interest was expressed in the Voluntary Qualified Importer Program (VQIP), which does provide facilitated entry for food shipments to the United States.

Camille Brewer

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

In late April, our public and private meetings in Mexico strengthened what has become a true partnership between our two countries. In 2014, we started the Produce Safety Partnership with the National Service for Agro Alimentary Health, Safety and Quality (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS)—our regulatory partners in Mexico—to help prepare growers and packers there to comply with the FSMA requirements. This flagship program forms the basis for extensive collaboration on produce issues.

Mexico continues to modernize and strengthen its own regulatory regime for food safety. Our strong and growing relationship with the Mexican government is a model for partnerships we’d like to forge with other nations. One of our central FSMA themes is working closely with foreign governments that share our food safety goals, and whose own food safety efforts can contribute to the safety of imported food. Our FDA office in Mexico helps to build and sustain our mutual food safety goals.

This is a priority for both Mexico and the United States because of the large volume of produce we trade and the importance of produce safety from a public health and confidence standpoint. Much of the produce we eat in the U.S. is grown in Mexico, including produce that would otherwise be hard to find in the winter months. A lot is at stake for both sides, and our meetings in Mexico reinforced our shared commitment to food safety.

A week before the Mexico trip, we traveled to Beijing for a FSMA public meeting and meetings with our regulatory counterparts in China—the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the China Food and Drug Administration (CFDA), and the China National Center for Food Safety Risk Assessment (CFSA). China also has new food safety laws. The interest in meeting FSMA requirements is so intense that the public meeting was shared across China by webinar, with more than 5,200 participants in government agencies, academic institutions, and industry.

There were meetings with Chinese officials about issues of mutual interest and strategic importance, in addition to subjects unique to China, such as the regulation of ceramic tableware and traditional Chinese medicine.

Like FDA, government regulators in China have been working to refine the food-safety infrastructure based on new laws. The sheer vastness of the country and the rapid pace of economic development and change  are key factors that government officials are taking into account as they refine their laws to control and monitor food production.

Progress is being steadily made and the FDA Office in China continues to work effectively with Chinese authorities to identify points of synergy. The visit culminated in a meeting of representatives of China, the European Union and FDA to discuss core food safety principles and other subjects.

So you can see our partnerships take on different forms. What we learned in our travels to Mexico, China and Canada is that each nation has a strong resolve to make their food supply safer for their own citizens and for export to other nations.

We will continue traveling to countries willing to partner with us in this mission. No matter where you live, no matter where you govern, everyone wants safe food.

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

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

Our Goal in Enforcing Food Safety: A Rapid, Science-Based Response

By: Stephen Ostroff and Howard Sklamberg

Recalls of potentially unsafe foods are an important food safety tool. The FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.

Stephen Ostroff, M.D.

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

The FDA Food Safety Modernization Act (FSMA) empowers the FDA to act when a company does not voluntarily cease distribution and recall a potentially dangerous food product. The enforcement tools provided by FSMA include mandatory recall.

Because the vast majority of companies choose a voluntary recall when presented with science-based evidence that their products are unsafe, or reasonably likely to be unsafe, the FDA has only rarely needed to use its mandatory recall authority. In most instances, companies choose to initiate a recall when faced with the prospect of an enforcement action.

The HHS Office of the Inspector General (OIG) has raised concerns about the sufficiency of processes and procedures the FDA has in place to ensure that firms take prompt and effective action in initiating voluntary recalls. To consumers hearing about the OIG alert, we want to be clear that the FDA is totally committed to its public health mission of ensuring the safety of the food supply. The United States has one of the world’s safest food supplies. The work we do—performing facility and site inspections, conducting surveillance sampling both domestically and at the border, and using laboratory and other analyses to help determine prevalence of food-borne risks—contributes to its safety each and every day.

Howard Sklamberg

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

As a public health agency, the FDA continually works to improve its processes and appreciates the input from the OIG. In fact, the agency is now expediting changes already underway to strengthen its compliance and enforcement strategies, including voluntary and mandatory recalls. This includes, in individual situations, specifying timeframes for voluntary action by the firm and, if necessary, enforcement action by the agency.

But before we get into those changes, it’s helpful to consider what generally occurs before a voluntary recall takes place. The FDA’s actions have to be based in science and we go where the evidence leads us. The scope of a contamination must be ascertained to determine how much of a product must be recalled. The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market.

Because the FDA acts on science-based evidence, it has credibility with food producers (and their internal and external legal teams) and consumers. Companies know that when they are approached by the agency, the danger is real and must be acted upon promptly. So the FDA, time and again, is able to protect consumers by engineering timely voluntary recalls.

The OIG’s concerns about the FDA’s food recall process are based on their selection of a “judgmental sample” of 30 voluntary recalls between October 1, 2012 and May 4, 2015 chosen based on their risk factor. The alert focuses in particular on two recalls in which the companies did not initiate recalls of all affected products for months despite the fact that FDA notified them as soon as the agency had evidence of a contamination. This finding is unacceptable–no question about that. It bears noting, however, that in those three years, the FDA worked with companies to successfully bring about thousands of recalls to keep unsafe food out of the market and homes of consumers with an average recall initiation time of less than a week.

We fully agree with the OIG that we must move as expeditiously as possible. We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.

To speed the FDA’s response when regulated foods are tied to real and potential public health risks, including outbreaks of human illness, the agency has recently established a new process to help streamline and strengthen decisions about compliance and enforcement actions.

We have established the Strategic Coordinated Outbreak Response and Evaluation (SCORE) team, a decision-making body of key senior leaders that will be co-chaired by those responsible for directing compliance and enforcement activities in the foods program and field operations. Team members are from FDA’s Foods and Veterinary Medicine program, the Office of Regulatory Affairs, and the Office of the Chief Counsel. They are advised by senior scientific, medical, communications, and policy experts. This builds on FDA’s establishment of the Coordinated Outbreak Response and Evaluation (CORE) network in 2011 to coordinate and streamline outbreak response, working with state and local authorities and other federal agencies.

What this team brings to the table is an integrated approach to identifying timely and efficient measures to help mitigate public health risks, goals shared by the OIG. It will review investigations that have, or may have, a link to specific foods or a food facility when there is a serious human health risk. It will also be involved when the case involves complex policy questions, when additional expert support is needed, or when response timelines have not been met. The SCORE team’s involvement will speed the FDA’s response by evaluating the whole range of options for use of compliance and enforcement authorities as quickly as possible.

The SCORE team has only recently been established, and we will be reviewing how it works, refining its functions and performance as needed.

There are other ways in which our enforcement strategy is already being strengthened. Since 2014, we have been using whole genome sequencing in the laboratory as a regulatory tool to more rapidly identify foodborne contaminants and trace them to their source with unprecedented speed and precision. This technique has already proven to be a game-changer in outbreak response, and will be increasingly valuable in the future.

Looking ahead, protections will be further strengthened by the FSMA-mandated preventive controls rules for human and animal food, which require covered food facilities to identify potential hazards and take steps to minimize or eliminate risks. They are also required to have a recall plan. Compliance dates begin for certain firms in September 2016.

Our stated mission to protect public health is more than just words on paper. We are always working to be better at our job and will use the OIG’s input as it was intended–to further strengthen our protection of the food supply.

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

Marking the Beginning of a New Era in Food Safety

By: Stephen Ostroff, M.D.

The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them.

Stephen Ostroff, M.D.These promises mandate that food be produced, packed and transported with an awareness of potential hazards and a commitment to taking whatever systematic steps are necessary to eliminate or greatly reduce any risks. They envision a world in which families can share foods produced halfway around the world, knowing that they are held to the same rigorous safety standards as those produced in the United States.

The past nine months have seen the finalization of the seven rules that make FSMA’s promises a reality – for both domestic and imported foods. The last of those rules, one that adds protections against intentional adulteration, became final on May 27. Together, and individually, these rules represent a paradigm shift from simply responding to outbreaks of foodborne illness to preventing them from happening in the first place.

There’s a lot of work to be done in the implementation phase. But even as we look forward, it’s important to recognize that getting to this point with rules that are final is a spectacular achievement, and that many deserve the credit.

Members of Congress joined together to pass FSMA in 2010 because of widespread concern over multistate outbreaks, and lawmakers like Sen. Jerry Moran of Kansas and Rep. Rosa DeLauro of Connecticut have been unwavering in their support since then. Consumers, such as activists in STOP Foodborne Illness, who became sick themselves or who lost loved ones to contaminated food, put their sorrow aside and became champions for the greater good. Public policy organizations like the Pew Charitable Trusts have been steadfast partners throughout the rulemaking and budget processes.

The food industry mobilized to help FDA find the most effective, practical ways to implement these regulations. We worked with national associations that include the Grocery Manufacturers Association and groups with a more regional focus, such as the New England Farmers Union. Farmers, manufacturers, distributors, retailers and many others whose livelihood is directly affected by these rules brought their concerns to the table and worked with us to make the rules as feasible as possible.

We found dedicated partners in other government agencies at the federal, state and international levels. Leanne Skelton of the U.S. Department of Agriculture has been part of the FDA team. The National Association of State Departments of Agriculture is playing an important role in helping FDA meet the challenges of implementing the produce safety rule. State agriculture leaders like Chuck Ross in Vermont, Katy Coba in Oregon and Steve Troxler in North Carolina became a bridge between FDA and the food producers in their states. Our regulatory counterparts in other nations, such as SENASICA and COFEPRIS in Mexico, have joined the fight to increase food protections worldwide.

The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system. I recently succeeded Mike as deputy commissioner, and I want to acknowledge the importance of his dedication to public health and food safety.

The FDA teams who drafted and revised the rules worked in tandem with teams laying the groundwork for eventual implementation. They have traveled the nation, and the world, to meet with food producers and government officials. They have worked 24/7 on these rules since FSMA became law.

The road ahead towards full implementation of FSMA is a long one. There are miles to go, but thanks to the commitment and hard work of all those who are making this journey, we will keep the promises of FSMA.

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

A New Partnership with Canada on Food Safety

By: Caroline Smith DeWaal

With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.

Caroline DeWaalSystems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.

Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.

With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.

Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.

For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.

Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.

Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.

Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition

Protecting Trade in Safe Food is a Global Concern

By: Sharon Mayl and Debbie Subera-Wiggin

Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring to provide outreach on FDA’s new food safety regulations.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

This was the 65th meeting of the WTO’s Committee for Sanitary and Phytosanitary Measures (SPS), an important body that provides a forum for the discussion of food safety and animal and plant health issues that affect the international food trade. While enhancing free trade is WTO’s focus, members understand the importance of facilitating trade in safe food products.

Working with the WTO Secretariat, the U.S. Mission in Geneva and the Office of the United States Trade Representative, we shared information about the FDA Food Safety Modernization Act (FSMA) rules that aim to help ensure the safety of foods exported to the United States. It was exciting to look out at the audience and see public health and trade officials from more than 33 countries and international organizations seeking to learn more about the new food safety regulations.

The United States has been a member of the WTO, which has 162 member nations and observer organizations, since 1995. Under the auspices of this SPS Committee, U.S. trade and regulatory agencies, including FDA, work with governments worldwide on trade issues related to food safety. Their work includes ensuring that the regulations of each nation support the rights and obligations of WTO agreements.

FDA incorporates these obligations into our regulatory process, specifically to ensure that our regulations are risk- and science-based, are created through a transparent process, and are equitable to both domestic and foreign producers, while protecting public health. The WTO SPS Committee is an ideal international venue for sharing information on FDA’s food safety rules.

Our job during this meeting was to share insights on three of the new FSMA rules — in particular, produce safety, foreign supplier verification programs, and accredited third-party certification.

We were very impressed by the interest that the countries’ representatives had in these rules. More than 50 representatives even skipped their lunch to participate in the outreach session and many returned that evening, after the main session closed, to continue the discussion!

WTO members are interested in understanding and meeting the regulatory requirements in FSMA rules so that they can continue to ship safe products to the U.S. Several of the participants expressed their government’s support for working cooperatively with us to strengthen food safety controls.

We left the outreach session with a better understanding that our trading partners are highly motivated to put mechanisms in place that will help their producers and manufacturers comply with the FSMA rules and contribute to robust trade partnerships.

Sharon Mayl, J.D., is a Senior Advisor for Policy in FDA’s Office of Food and Veterinary Medicine; Debbie Subera-Wiggin is a Consumer Safety Officer on the International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition.

FDA-State Partnership Propels FSMA Implementation

By: Michael R. Taylor and Stephen Ostroff, M.D.

Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state government. This is especially critical in the new area of produce safety regulation.

Michael R. Taylor

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

After years of rulemaking – of planning, discussing and revising – this partnership is no longer just an aspiration. Instead, it’s evolving into a real union of public health and regulatory colleagues at the state and federal levels who together are taking concrete steps to make the produce safety protections envisioned by FSMA a reality.

An example of this forward movement is a conference we both attended on March 22 in Orlando, Florida, where the National Association of State Departments of Agriculture (NASDA) unveiled its proposed framework for state participation in the implementation of FDA’s new produce safety rule. This rule—for the first time—establishes enforceable federal safety standards for the production and harvesting of produce on farms.

In 2014, FDA entered into a five-year cooperative agreement with NASDA to work with state partners to collaboratively plan implementation of the produce rule. The NASDA framework will help guide and inform states that are working to develop a state produce safety regulatory program that is aligned with the FSMA rule.

The NASDA framework was developed with the active involvement of 24 state departments of agriculture and five national public health organizations. Key areas addressed include education and compliance, information sharing, regulator training, accessing laboratory resources, technical assistance, and infrastructure.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1

All 50 states were represented at the Orlando meeting to review and discuss the proposed framework, which is intended by NASDA to be a living document that can be refined and improved over time as experience is gained with implementation of the produce safety rule. The level of alignment and energy among participants at the conference – which included 46 agriculture departments and 19 public health departments – was inspiring and demonstrates that we are very much on the right path toward a sustained partnership with our state colleagues.

The states have always been clear in conversations with us, and we have been clear in conversations with Congress, that federal funding is necessary for the work ahead. State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently. But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.

But this requires resources.

The President’s Fiscal Year 2017 budget request includes $11.3 million in new funds for the National Integrated Food Safety System. We have been building this system to fully integrate the more than 3,000 state, local and tribal government agencies involved in food safety in FDA’s work to meet the FSMA mandate. The FY 2017 funding, which Congress is considering, will be used primarily to support state produce safety programs through cooperative agreements and grants.

The FY 2017 funding builds upon resources for states that Congress provided for FSMA implementation in FY 2016. Earlier this month we took an important step toward distributing these funds – $19 million – to support state produce safety programs by soliciting applications for cooperative agreements with state regulatory agencies. These funds will make an important down payment on the capacity states need to be our full FSMA partners in produce safety. The FY 2017 funding request recognizes that more will be needed – both next year and beyond — to realize this goal.

There is a great diversity in where states are right now in planning and developing their produce safety programs. Some may already have developed multi-tiered plans and are ready to begin implementing. Others may just be starting to consider what’s ahead. This program is designed to give states the support they need at whatever stage they’re in.

Our goal is to get the initial funding to a number of states before the end of this fiscal year.

This has been a long road. But we are gaining real momentum toward the ultimate goal of having a food safety system in place in which government agencies at all levels are working in partnership with each other – and collaboratively with farmers – to ensure that we are doing everything we can to prevent or reduce the risk of foodborne illness. Safe and widely available produce is good for consumers, good for public health, and good for growers. That’s why we’re all in this together.

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.

Priorities – Teamwork to Achieve Common Goals

By: Robert M. Califf, M.D.

With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success.

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug AdministrationThis is hardly surprising. FDA regulates about 20 percent of the nation’s economy and, given the vast number of options, it would be easy to get lost in an overwhelming swirl of activity. In fact, at times I have been (rightfully) accused of having an excessively lengthy to-do list! But my interactions with so many of the knowledgeable, dedicated, and mission-driven people here at FDA have helped foster a clear, realistic, and focused sense of priorities and have further heightened an already strong enthusiasm for helping this awesome organization reach these ambitious goals.

FDA makes decisions in a remarkably effective and responsible way. Guided by the lodestone of our mission to protect and promote the public health, and supported by the concerted efforts of dedicated and talented professionals who examine issues within team-based systems, FDA’s Centers that form the core of our organization are able to make an enormous number of decisions every day. The vast majority of these decisions, many of which are vital to the well-being of all Americans, are made possible by a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies.

I strongly believe my most important responsibility during my time at FDA is to encourage and support a professional environment that enables our remarkably dedicated workforce to thrive and to reach its fullest potential. Dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change. But amid this change, the key to success for the Agency in accomplishing its mission remains constant—sustaining and expanding our talented workforce and ensuring that we both hire the people we need for the future while we continue to enhance our environment to ensure that we retain existing staff. To that end, I will pursue a workforce initiative designed to 1) improve the hiring system, 2) ensure that the Agency has the best possible working conditions for staff, and 3) foster professional homes for the diverse professions that make up our teams so that we are able to recruit and retain them in a very competitive market.

My top programmatic priority will likely come as no surprise, given the astonishing changes that are currently rippling through society: we must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean? I’ve noticed that when high-quality evidence is available, FDA’s scientific decision making is often straightforward. But it can be particularly challenging for the Agency when it must make scientific decisions in the absence of optimal information. In such cases, opinions may carry greater weight, and there can be an increased likelihood of dissension both inside and outside of FDA, as well as a greater risk that we may fail to most fully protect or advance the welfare of patients and the public.

FDA is a science-based, science-led organization that focuses on the needs of patients and consumers; protecting their well-being is our charge as a public health agency. The state of the art as it pertains to understanding the needs and choices of patients and the public is progressing rapidly, and we must continue to keep pace by incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of our work.

Biomedical science is nearing a tipping point where the amount of high-quality evidence available to support our decisions is likely to increase exponentially. As a nation, we have invested over $50 billion to provide an electronic health record (EHR) for almost every American. Further, computational storage capacity and analytical power are increasing by orders of magnitude from year to year. At the same time, the advent and wide diffusion of social media are enabling direct communication with patients and consumers on an unprecedented scale. When projects such as Sentinel and the National Medical Device Evaluation System are linked with the many complementary initiatives under way at our sister agencies and at organizations outside of the government, we can (and I believe in short order will!) build a robust foundation for a system in which both private and public sectors can produce much more useful knowledge at a fraction of the cost such efforts have previously required. Indeed, a major function of FDA is to support the continued development of an effective system for evidence generation, so that the private and academic sectors can make it happen.

Accordingly, FDA is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality scientific evidence needed to guide FDA’s decisions about the drugs, medical devices, tobacco products, and food products it’s charged with regulating, as well as the decisions that healthcare providers, patients, and consumers make about their health and well-being.

In addition to this overarching priority, a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:

  • Pain. The present epidemic of opioid overdose deaths now exceeds deaths from automobile crashes. FDA cannot solve this problem on its own—and indeed, no single entity can—but we have a critical role to play, as described in our FDA Opioids Action Plan.
  • Tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
  • Implementation of the FDA Food Safety Modernization Act (FSMA). This statutory directive to transform the food safety system is well on its way to being implemented, with critical regulations issued and more to come. The effort involves the complex development of a new control and risk-based system that includes the entire chain of food safety. Effective implementation of this system will require the application of cutting-edge analytical and biological science, as well as the most modern approaches to human systems management.
  • Antimicrobial resistance. Concerns about the proliferation of multidrug-resistant pathogens, as well as the sustainability of the product pipeline needed to meet this threat, continue to grow. We have a major responsibility in the federal plan, one that will involve many parts of the Agency and require that we work with the broad ecosystem, both to ensure that appropriate antimicrobials are used appropriately on farms, and that novel antimicrobials are developed, approved, and used responsibly within a framework of effective stewardship.
  • Interagency effectiveness. When we consider our mission to protect and advance the public health, as well as our duty to balance benefit and risk for patients and consumers of medical products, much of our success can be enhanced by coordinated effort across government. We have therefore continued the FDA-NIH Joint Leadership Council and the FDA-CDC meetings, and also initiated similar discussions with CMS. The Biomarkers, Endpoints and other Tools (BEST) Resource offers a powerful example of the ability of FDA and NIH to contribute to solving scientific and regulatory issues together.
  • Precision Medicine. President Obama’s Precision Medicine Initiative represents more than just a project. Rather, it is a window that provides a clear view of the future for biomedicine and agriculture, a future in which powerful new technologies and methods allow the precise targeting of interventions using an array of genetic, genomic, biological, clinical, social, and environmental data according to the scale needed to achieve improved health outcomes.
  • Cross-Cutting Issues. There are a great many other issues (truthfully, the number reaches triple digits) on my list of concerns. But those issues that cut across the Agency, including optimizing our approach to combination products, medical countermeasures, and improving product labeling, will benefit most from my attention and support.

A single introductory blog post is not suited for giving details about priorities or individual programs. However, I hope I’ve conveyed my enthusiasm for the work at hand, as well as my confidence that we will be able to make real and lasting improvements in many critical areas. I promise that we will follow up with frequent updates, as fostering effective communication is itself an overarching priority of immense importance to me. So expect to hear from me again soon!

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration