Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
NASDA Annual Conference
September 12, 2017
New Orleans, LA
(Remarks as prepared for delivery)
I want to take a moment to acknowledge those who have been hurt by the twin hurricanes, and those who have died in these storms. I know some of our colleagues couldn’t be with us today because they are back in their states dealing with the aftermath of these disasters.
My thoughts -- and I know the thoughts of all of you -- are with them. At FDA we’ve got a large team working on providing assistance to those affected by these storms. You’ll be hearing a lot from us in the coming weeks, as we do our part to help people recover from these tragic events.
I appreciate the opportunity to come to this event to meet you and to introduce myself. You’re all critical partners to FDA, in our shared goals focused on the promotion of food safety and the public health.
I want to focus my remarks today on how we can successfully implement FSMA, in particular the produce safety rule. Aside from the eight egg-laying hens my family raises, and our berry bushes, I can’t claim extensive farm experience. However, my past experiences at FDA gave me a great deal of exposure to, and appreciation for, food safety.
During my second tenure at FDA, I was the agency’s deputy commissioner. In that role, I became one of the agency’s point people in responding to the 2006 E. coli outbreak in bagged spinach.
Two hundred people across the country became ill from that incident, and three died, including a 2-year-old child. I learned from that incident about the complexity of our food supply, the vulnerability of our food to contamination, and the devastating impact of an outbreak like this on human lives. I also saw how impactful outbreaks can be to the food industry as product is lost and consumer confidence dwindles.
During my previous tenures at FDA, the agency’s limited authorities and resources made preventing and handling outbreaks incredibly frustrating and challenging. We just didn’t have the necessary tools. This and similar public health crises taught me a valuable lesson about the importance of preventive steps to achieve food safety. And how critical it is that we modernize our framework for approaching these challenges.
As all of you know, FSMA’s enactment is the most sweeping reform of our food safety laws in more than 70 years. It’s grounded on a collaborative effort between FDA and its state partners in the creation of a fully integrated food safety system. FSMA represents a profound and fundamental change in our approach to food safety. And the law evolved from a number of food outbreaks that led to true public health emergencies -- outbreaks that compelled Congress to make sweeping statutory reform to ensure that the public health is protected.
I believe it is important that we remember why this law was enacted -- and why we are here today -- to protect our food supply.
I know that you share these goals, and that NASDA has an interest in many aspects of FSMA. But today, I’d like to spend some time talking specifically about how we best implement the produce safety standards. This aspect of FSMA is at an especially critical juncture, and we’re going to need to work together to make sure these provisions are realized.
A few weeks week ago, I had the opportunity to tour farms and packing facilities in Georgia with Agriculture Commissioner Gary Black. I was able to experience first-hand the pride, ingenuity, and determination that make the farming community the backbone of our nation.
This trip helped deepen my appreciation for the challenges and complexities that the farming industry faces in a globalized food market. It was evident to me that a one size fits all solution simply won’t work for this industry. This trip deepened my commitment to work with you and our farmers to ensure that the fruits and vegetables we serve our families are safe and that consumers have confidence in the products they consume. I’m grateful to Commissioner Black for hosting me.
This trip also served as a reminder of how farms are different than the other entities we regulate. Farms are not just a place of business. Many are homes. Most farms have been in families for generations.
The dedication and commitment farmers have to providing safe and healthy food for Americans and the world is evident. Under my leadership, FDA is committed to working with farmers and our state partners to ensure the safety and quality of the American food supply.
Collaboration is key to the success of this law. One of the many examples of this is the implementation of the Produce Safety rule. Let me say this plainly: The Produce Safety Rule will not work without you.
We recognize and understand that there’s a lot of work ahead in terms of guidance, training, and considering how we can simplify some of the standards. The states and NASDA have been important and trusted partners in the extensive work we’ve already done. I know that this partnership needs to be made even stronger as the new standards move from paper documents to the real world. Maintaining an open line of communication between FDA and this organization is vital to our collective success in achieving the public health goals FSMA envisioned.
I’m not here today to talk in generalities and to reassure you that this will all work out in the end. I’m here to tell you that it will work out in the end. But it won’t work if FDA doesn’t work with the states to take some new steps to address the challenges that have become increasingly clear since the produce rule became final in November 2015. The truth is, there are things we’ve done well in getting this rule ready for prime-time. But there are also things that may require a course correction.
I think we all agree that the successful execution of the produce rule is conditioned on an extensive set of activities to support its implementation. Those activities must be well coordinated.
Today, I’d like to talk specifics on what we see as some immediate next steps as part of a comprehensive approach to getting produce safety implementation right. I’m going to discuss the challenges with the agricultural water standards. I’m going to talk about how we prepare our staff and the farming community for the upcoming produce compliance dates and how we approach those initial interactions on farms. This includes how we handle training, technical assistance, guidance development, and the new efforts we’re putting into addressing dispute resolution. I want to discuss these steps with you in detail.
One issue we’re addressing is the concern we’ve heard about the agricultural water standards in the produce rule. We agree that FDA needs to take another look at our approach given these concerns. There’s a consensus that agricultural water can be a major conduit of the pathogens that contaminate produce. To make FSMA work for the long run, it’s important we have a workable approach to water.
One consistent and clear message we received throughout our outreach to farmers and state agriculture officials is that the microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented. We hear your concerns. We take them seriously. That’s why we announced our intention to explore ways to simplify our approach to make compliance less burdensome and less costly, while still being protective of public health.
To give all of us more time to do that, I’m pleased to announce that today we’re issuing a proposed rule to extend the compliance dates for the agricultural water requirements of the produce rule for non-sprout produce by an additional two to four years. This way the earliest non-sprout compliance date for the water standards won’t be until January 2022. This gives us time, over the next four years, to hammer out the most effective and practical approach for agricultural water.
We’ll work with you and other stakeholders as we consider this issue. The process will be broad and transparent. As part of this effort, I’m pleased to announce that early next year; we’ll participate in a summit on agricultural water quality and testing, similar to the very valuable summit on biological soil amendments that was held earlier this year.
We want to learn more about the diverse ways that water is being used in farms across the country so that we have standards that will work for everyone, and won’t be overly burdensome to growers. We need to make sure this new framework is practical and workable.
I believe deeply in the protections enabled by FSMA. I support its goals. My aim is to make sure we take smart steps to make the law viable.
We also heard concerns about the practicality and availability of water testing methods and have taken steps over the past few days to acknowledge a number of methods that are acceptable for use. Dr. Steve Ostroff will be discussing this further during his talk tomorrow.
Additionally, our new cadre of Produce Safety Network experts across the country will help us gain first-hand information on the practices and conditions that will inform our next steps. We’ll work closely with the farming community, state and tribal leaders, and our counterparts at USDA to make this work. We understand that your assistance and collaboration is integral to the success of these efforts.
At FDA, we also need to reconsider how we work with growers, day in and day out, to implement these provisions. All of us share the same goal: to make sure that our food is safe. The best thing FDA can do for producers and our regulatory partners is to be sure they understand what’s required of them in a post-FSMA world. That means also making sure they have the resources to implement the rule. With FSMA’s shift from being reactive to preventive, this is especially important.
It is important that FDA provide regulatory clarity so you can plan and implement standards in the most efficient and effective way. This is a principle that’s true across the board at FDA. While visiting farms in rural Georgia I was reminded of how unpredictable and challenging farming can be. There are many things beyond a farmer’s control, ranging from weather and white flies to fluctuating prices and requirements from buyers. I recognize these challenges. I want to create a regulatory culture that provides both certainty and flexibility rather than yet one more unpredictable variable for our farm communities.
I’m committed to taking a comprehensive approach to ensuring that industry and regulatory partners have the tools they need to implement FSMA. I’m talking about training, technical assistance, and guidance documents to make our expectations clear.
I want to lay out some of the specific issues that we’ll be tackling as part of this comprehensive approach to regulatory clarity and greater collaboration. Since the inception of FSMA, both Congress and FDA knew that the states would be essential in implementing safety standards. We’ve always known that FDA couldn’t do this alone.
In addition to providing guidance and education, part of FDA’s responsibility under FSMA is also providing funding. This money supports the development of state produce safety programs.
FDA recently announced that more than $30 million has been awarded to fund the State Produce Implementation Cooperative Agreement Program to support 43 states in their development of produce safety programs. This builds on the nearly $22 million in cooperative agreements that FDA awarded last year to 42 states to develop produce programs and provide training and technical assistance. Most states chose the option that includes funding for an inspection, compliance, and enforcement program, in addition to grower education, outreach, training, and technical assistance.
For the seven states that have not yet applied, there’s still an opportunity to participate. We remain committed to working with states that haven’t already applied for a cooperative agreement. I’d urge you to speak with the ORA Office of Partnerships about these programs.
While our original intent was for states to begin inspections during 2018, to be consistent with the January 2018 compliance dates for larger farms, I’m announcing today that we’re changing course. We’ve heard very clearly from farmers and other stakeholders, including NASDA, that more time is necessary to ensure farmers have the training and information needed to comply and that states establish strong produce regulatory programs before inspections begin. We agree.
So FDA is modifying the approach outlined in the cooperative agreements. Routine inspections won’t begin until the spring of 2019.
We understand that the decision to postpone routine inspections in year two of the Cooperative Agreements may impact the strategic plans and budgets that states have already submitted. You’ll receive information this week from FDA’s Office of Regulatory Affairs that will describe next steps in modifying your strategic plans and budgets.
We want your input on how these inspectional resources could be used next year to best prepare farmers for inspections. There will be flexibility here to accommodate alternate plans. However, let’s be clear. This new timeline doesn’t signal a pause in our efforts and decisions. FDA and the states need to use this additional year as an opportunity to focus on issuing guidance that will be helpful to regulators and farmers, providing training and technical assistance, and improving information for work planning such as developing farm inventories.
On Farm Readiness Reviews
One of the efforts that’ll help support farms in complying with the new standards is the On-Farm Readiness Review. On-Farm Readiness Reviews are voluntary farm visits by a team of state officials, cooperative extension agents, and FDA produce experts to provide farmers with an assessment of their “readiness” to meet the new requirements. The reviews also help state and federal agencies assess the level of compliance with the Produce Safety Rule across the country and to identify areas of the rule where farmers may need further education or training. They also provide on-farm learning experience for regulators to aid in identifying gaps that may need to be filled with additional training or technical assistance for regulators themselves.
I’d like to thank NASDA for your help in developing On Farm Readiness Reviews; you’ve been a leader for this effort. We want to work with you to ensure that farmers take advantage of this creative approach.
Working together, we have already pilot-tested On-Farm Readiness Reviews in six states, and NASDA and FDA are planning to roll out the program nationally this fall. As you all work to update your resource planning for the year two cooperative agreements, I strongly encourage you to consider reprogramming resources planned for inspections in 2018 to conducting On-Farm Readiness Reviews, because our experience indicates that these will be an influential tool for helping farmers and regulators have the regulatory clarity they are looking for.
We know that getting the word out about On-Farm Readiness Reviews is crucial. Farmers need to understand that this tool is for their benefit.
I know that NASDA has put a lot of thought into how to promote these reviews and has an extensive plan for helping states roll out these opportunities. In addition, I’ve asked our team to hold additional conversations with NASDA on what additional steps FDA can take to more actively promote these opportunities with farmers.
Another critical area of FDA focus is in providing training. A lot of work to provide training has already been done through the Produce Safety Alliance and other programs. Through the PSA training alone, 176 farmer training courses have been conducted in 36 states as of June, with more than 4,000 farmers trained. There have also been 31 train-the-trainer courses in 25 states, with more than 1,000 trainers trained.
On the international front, a partnership, called Produce International Partnership for Education and Outreach has been formed and is charged with coordinating the international outreach strategy for the Produce Safety Rule and adapting the standardized curriculum to international audiences. This outreach is being conducted in a manner that’s consistent with PSA’s domestic efforts, and considerate of the cultural, technological, and language differences and needs.
Through our foreign posts, FDA is reaching out to our foreign regulatory counterparts. For example, we receive a great deal of produce from Latin America, and our Latin America Office is actively engaged with our trading partners on outreach.
I also know that we also have a responsibility to train our own regulatory staff. I know that this is a major concern for all of you. Because of the prominent role that state regulators will have in the implementing this rule, training is critical. I’d like to take a moment to update you on the status of these activities.
As many of you know, a NASDA-FDA working group was formed to work on plans for training state and federal inspectors. This group piloted a regulator training course last month. It’s currently finalizing plans for the initial wave of training modules for produce safety.
We currently have four regulator training courses planned for 2018. Details around the produce training will be shared through a webinar for participants in the state cooperative agreements in October.
Through our work with NASDA, we understand that more training opportunities need to be established. The NASDA-FDA working group has helped us determine that there may be around 60 additional state regulators that will need training outside of the four courses already planned. We’re committed to offering more training courses before the start of inspections to ensure we train inspectors to meet these needs.
Additionally, the Produce Safety Network is also putting together a Technical Assistance Network for regulators. This will let state regulators working in the field get answers to questions as they come up to speed on the standards, and as they eventually perform inspections.
We’re also growing our Produce Safety Network, which consists of FDA produce safety experts located across the country. Their goal is to support the efforts of farmers, regulators, and other key stakeholders to implement the produce safety rule. I had the pleasure of spending time with one of our new PSN Experts during my trip to Georgia a few weeks ago, Trevor Gilbert. There are now 21 members of this team. There are more to come. I’m confident that this team will be a great resource to support educational and compliance efforts.
Before I leave the topic of training, I also want to speak to the need many of you have identified related to training for cooperative extension agents. We understand that many farmers count on cooperative extension agents to provide valuable education, outreach, and technical assistance at the state level. Recognizing how important these agents are to farmers, FDA is also working with NASDA to determine the best training platforms for ensuring that cooperative extension agents can have the training they need to be effective.
Another tool for educating the produce industry and our regulators is through sharing additional guidance. As many of you know, we have been working on a rather large guidance document on the Produce Safety Rule. We recognize and understand that there’s some frustration that this guidance has not come out yet.
Clearly the process has taken longer than many had hoped. But we expect to publish the draft guidance early next year. We’ve ensured that NASDA representatives are having input into the guidance development, and we’re building in additional time for their review.
I’d also like to note that we recently released a Small Entity Compliance Guide for produce. This, in addition to the preamble to the rule, has valuable information for all stakeholders, though the SECG is particularly geared towards the needs of smaller farmers.
Finally, I want to spend a moment on dispute resolution. I fully understand that this is a central concern for all of you. FDA has heard the concerns you’ve raised regarding the use of the traditional FDA 483 to document regulatory issues during produce inspections, and you have asked for us to consider additional approaches.
In recent weeks, I’ve had several discussions with our field leadership on this issue. As a result of these early conversations, we’re planning to explore additional ways of communicating our concerns about what we observe during produce inspections. We are also considering ways to effectively and efficiently provide feedback to farmers that would help them focus their corrective actions. We look forward to talking to you more in the future about these efforts.
The areas I’ve laid out are key activities that I consider critical to building the comprehensive foundation that’s necessary to ensure that the public health gains envisioned by FSMA become a reality. I’m committed to make FSMA work for the long run. It’s essential that we get this framework in place. And I’m committed to taking steps now to prevent devastating outbreaks like the spinach outbreak that I first grappled with during my last tour at FDA.
I know there are other concerns related to the various FSMA rules, not just produce. These include topics like parity between domestic and imported foods and the definition of a “farm.” Recent conversations have also shown us that we need to provide greater clarity to our regulatory partners in a number of areas related to the other FSMA rules.
I recognize that all of these issues cannot be resolved immediately. To deal with these and other FSMA issues, I’m convening a group of senior FDA and NASDA leaders to meet regularly to discuss significant policy issues that arise. I’ve asked my colleagues -- Deputy Commissioner Stephen Ostroff and Associate Commissioner Mel Plaisier -- to facilitate these meetings. The first meeting is being scheduled now. I plan on attending that meeting. I’m personally committed to ensuring that this effort gets off to a successful start.
I’d also like to supplement these meetings with a regular communication from FDA to the agricultural leaders in each state to update them directly on where we are in implementing FSMA as well as more regular posting of information to the public.
We’ve committed to rethink certain provisions. We’re pushing back inspections. And we’ve created a structure for continued collaboration. I believe the steps I outlined today set all of us up for successful implementation. We need to get this right. We need to get it done.
The work we’re doing together will make life better for generations of Americans consumers and farmers. We shouldn’t lose sight of that, as we work together to get this new framework properly implemented.
Thank you the invitation to be here today to speak. I look forward to working with you to make this program a success.