- Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )
Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
NASDA Winter Policy Conference
Thank you for inviting me. A lot has happened since the first time I spoke to you last September in New Orleans, and I’m very grateful for your partnership in advancing our work. America’s farms and farmers are the backbone of America’s economy, and a trusted source of nutrition for families here and around the globe. NASDA’s collaboration is helping the agency create a transparent, flexible, framework to ensure 21st Century food safety standards efficiently address potential hazards before they enter the food supply to protect consumers and enhance confidence in our Nation’s food supply—whether sourced domestically or abroad.
We’re also cognizant that the FDA Food Safety Modernization Act or FSMA represents the most significant change to the regulation of the food supply in the last 70 years, and that these changes need to be implemented thoughtfully, with adequate time to ensure that farms and states can successfully adapt to new requirements and training programs. America’s farm community is diverse, and this needs to be taken into account through flexibility in how we – FDA and the states – implement the relevant FSMA regulations.
Back in September, I announced the proposed extension of the compliance dates for the agricultural water standards in the FSMA Produce Safety Rule. This change was proposed to give more time for us to revisit the ag water provisions and attempt to identify a less costly and burdensome approach that was workable for farmers while still protecting public health. In addition, I announced that routine inspections to ensure compliance with the Produce Safety rule will not start until 2019 to give more time to provide industry and regulatory partners with the tools needed to successfully implement FSMA. These tools include On-Farm Readiness Reviews, farmer and regulator training, guidances and technical assistance efforts to help make expectations clear.
Since then, I have become even more convinced that we cannot achieve FSMA’s full potential without you. Your expertise; your commitment to your farm communities; and your drive to protect the citizens of your states from harm are the lifeblood of this work.
Your feedback is also essential. Our partnership must be one in which we can air mutual concerns in a very frank and constructive manner, and acknowledge that we each have core responsibilities for ensuring the success of implementing FSMA. FDA is committed to maintaining our dialogue, which has been very productive.
Even today, when “FaceTime” has a very different meaning than it did 10 or 15 years ago, there is no substitute for face to face discussions. Sitting down with NASDA in September, and again in November, gave both leadership teams a chance to move beyond speeches and documents, air real concerns, and work on practical solutions.
It’s not lost on me that many of our advances have come over the course of shared meals, including a working lunch with Secretary Perdue that led to a formal agreement between the FDA and USDA that I’ll talk about later. As farmers and growers have known for countless generations, breaking bread brings us together as few other things can.
Today, I would like to take some time to update you on a number of topics we discussed in New Orleans, as well as in subsequent discussions with the NASDA staff and the NASDA Food Regulation Committee, as well as provide you with greater details on some additional steps we are now taking to assist our food safety modernization efforts.
I’d like to start with what we’ve done since September to provide clarity about the FSMA rules and address concerns that have been shared by NASDA and other stakeholders.
Farm Definition: FDA understands the need to reexamine the definition of a farm, along with several other challenges in the FSMA rules. This includes how entities like packing houses, warehouses, and terminal markets are covered by the produce and human food preventive control rules and how silage is covered under the animal food preventive control rule.
We agree that more work is needed, and we are pursuing long-term solutions to addressing these issues. This work will take some time, but we recognized that industry needed clarity on near-term expectations until permanent solutions can be implemented. That is why we issued a Federal Register Notice earlier this month announcing our intention to exercise enforcement discretion for certain provisions in the FSMA rules, including those related to the farm definition.
Produce Guidance: We are also eager to finalize our produce guidance, which NASDA representatives have had an opportunity to review.
I know you are concerned about the complexity of the guidance. That may be hard to avoid entirely given the complexity of the rule. But, we are exploring options suggested by NASDA for extensive accompanying communications that are more user-friendly and that direct farmers to the most helpful information.
Agricultural Water: And then there’s the important issue of agricultural water standards and testing. We committed to ensuring NASDA has a seat at the table to discuss and address how we approach agricultural water in the produce rule. In fact, NASDA is actively engaged in developing the agenda for the upcoming Agriculture Water Summit that will be held in late February in Kentucky. We have also taken steps to acknowledge additional testing methods that are acceptable for use.
PC-Animal Food: As you saw, last week we issued the first five chapters of a draft guidance to help animal food facilities subject to the Preventive Controls for Animal Food rule develop a food safety plan to significantly minimize or prevent hazards that could cause illness or injury to people or animals. Because this is the first time animal food facilities have been regulated this way by FDA, this guidance was long awaited and we’re happy to make that available.
FSVP: Last week, we also issued guidances related to the Foreign Supplier Verification Programs (FSVP). FSVP is an important new tool that requires U.S. importers to ensure that their foreign suppliers use processes and procedures that provide at least the same level of public health protection as the preventive controls or produce safety regulations.
Two of these documents, a draft guidance and a Small Entity Compliance Guide (SECG), are meant to help industry meet the FSVP requirements.
A third draft guidance addresses the term “same level of public health protection” that is used in both the FSVP and Produce Safety regulations. This draft guidance aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food.
I hope you’ll agree these recent announcements show FDA’s continued commitment to provide greater clarity about our expectations. We look forward to continued feedback on this work.
Partnership with States
Congress recognized that the states would be crucial collaborators with FDA in making the FSMA rules not only effective and efficient but flexible to accommodate local conditions and practices.
So, I am very pleased that so many of you are working with FDA on produce safety activities. I consider it an outstanding success that 43 states have already received cooperative agreement funds (a total of $22 million in 2016 and more than $30 million in 2017), and we know that several of the remaining seven states are planning to apply for funding in 2018.
I’m also happy to report that we have successfully completed the process to shift this year’s cooperative agreements to focus more on training and On-Farm Readiness Reviews.
On-Farm Readiness Reviews
The concept of On-Farm Readiness Reviews provided by NASDA, is one we quickly agreed with and embraced. This concept is now quickly becoming a reality. We appreciate the amount of effort that NASDA has put forth in developing OFRR training and stakeholder outreach plans.
I’m thrilled that the NASDA-led training on how to conduct readiness reviews is officially underway. Just last week, NASDA offered the first two readiness trainings in Florida and California, and there are 11 more training sessions planned across the country between now and May. FDA’s Produce Safety Network staff is actively participating in these training sessions. In addition, states are working to set up mechanisms for farms to request reviews, which will officially begin as the summer growing season advances.
We have also been taking steps to ensure that there are high rates of participation in these reviews. Last year, we heard from NASDA that some farmers may be hesitant to sign up unless there is clarity on what will happen if the reviewers have concerns about what they see on the farm.
In addressing this concern, we’ve tried to balance the need to encourage farmers to participate in this useful educational exercise while also recognizing the need to protect consumers if we find conditions that represent a potential health hazard. We’ve communicated our decision internally and to NASDA that we will not require reporting of such conditions to FDA, as long as the farmer makes immediate corrections and no product associated with this condition is in the chain of commerce. If, however, the product has entered into interstate commerce and may be subject to recall because of the potential hazard, documentation would be required, as well as FDA notification.
In addition to these steps, I am personally committed to highlighting the great educational opportunities provided by On Farm Readiness Reviews. I am hoping that I will be able to join NASDA in a stakeholder event this spring to bring additional attention to this useful tool.
I would like to acknowledge NASDA for all the work you have done on these reviews. We are committed to participating with you and supporting these efforts. I understand that some states already have waiting lists of farmers that have requested readiness reviews, which shows their value. This work has been an excellent example of the collaborative approach to food safety that we are striving for in a more fully-integrated food safety system, and it is a great example of the educate-before-we-regulate approach.
There are other efforts underway as well to support our emphasis on training for 2018. This includes progress on training for industry, state regulators, FDA inspectors, and Cooperative Extension agents.
Through training offered by the Produce Safety Alliance alone, more than 300 farmer training courses have been conducted. This includes domestic trainings in 39 states and over 80 international trainings. So far, more than 6,000 farmers have been trained through these programs. There have also been 35 train-the-trainer courses in 26 states, with more than 1,100 trainers trained.
To support the international community, the Produce International Partnership for Education is developing and distributing food safety training and outreach, ensuring that the educational materials available are culturally and technologically sensitive.
I know that regulator training is of special interest, and is key in preparing your staffs to conduct inspections starting in 2019. Working with NASDA, we’ve identified the number of additional state regulators who will need training, and I’m happy to say that the six trainings planned for 2018 should cover the remaining training needs.
We also heard NASDA’s concerns around the content of the produce regulator training courses. We understand and agree that the first round of regulator training is critical and we both agreed that no training course, especially the first one in a previously unregulated area, will be perfect. We heard NASDA’s concerns that extension agents are critical partners in our “educate before and while we regulate” approach and that they require training, in order to help farmers comply with the rule.
Last December we took an unprecedented step in hosting a workshop to review the produce regulator training and receive feedback from NASDA and industry on how the training can be improved. We received valuable input, and are committed to making fixes to the curriculum where necessary.
As you may know, we did launch the produce training for regulators this month. While the training content remains a work in progress, it will continue to evolve as we learn more about the industry and get more experience under our belts. We have committed to not only provide additional training and information to participants of the early classes as it becomes available, but to also provide an updated training-information webinar or similar action prior to the start of inspections in Spring 2019.
Inspectional Documentation and Dispute Mitigation and Resolution Procedures
While we have accomplished a lot in recent months, there are still issues to resolve. FDA remains committed to evaluating new inspection documentation and dispute resolution processes. Like you, we want to establish processes that promote fairness and consistency between FDA and state inspections, and that promote effective, efficient communication of any concerns that are observed during produce inspections.
FDA staff have held extensive conversations with NASDA on what processes can be established to avoid and, if necessary, resolve disagreements about inspectional observations. In these conversations, we have made forward progress on a number of steps FDA will take to mitigate the potential for disputes to occur in the first place.
At our November meeting of the FDA-NASDA Leadership Group, it was clear that we had succeeded in reaching full agreement on many components of the framework for dispute mitigation and resolution. Nevertheless, we still have work to do on the procedures that will take place if a dispute between regulators does occur. For this remaining component, there are legal questions that we continue to discuss internally. I have a sincere interest in resolving the concern, and am exploring various options.
We have also continued to work on a format for investigators to communicate observations to farms. As part of this effort, for inspections that will be FDA-led, we are exploring what we can do, within our statutory requirements, as an alternative approach to the traditional 483 process.
We have heard NASDA’s concerns about the existing process for correcting errors on the 483. We are exploring how to reduce the chance that inaccurate or out-of-scope observations are included in the first place, and possible alternative approaches to documenting inspectional observations.
We look forward to discussing additional details on dispute resolution as well as the alternative 483 proposal with the newly formed FDA-NASDA Leadership Group at our next meeting, which we are currently scheduling for March.
State Roles in Implementation of Other FSMA Rules.
Let me return to the roles of the states and the work we have to do to provide additional specificity and clarity around state roles and responsibilities for implementing other FSMA rules, including the Preventive Controls for Human Foods, the Sanitary Transportation Rule, the Foreign Supplier Verification Rule, and the Intentional Adulteration Rule.
Late last year, we provided a webinar for our state regulatory partners on the Preventive Controls for Human Food rule; specifically focusing upon state roles. This webinar was extremely well received and we have decided to hold additional webinars on the other rules in early 2018. Dates for those should be announced next month.
Last year we also entered into a cooperative agreement with NASDA to develop a framework for states to implement the Preventive Controls for Animal Food rule. Through hard work and dedication from NASDA member, representatives from state animal food programs, and FDA, the NASDA-led working group is making significant progress on the framework and we are eagerly anticipating when the framework will be ready for implementation.
We have also heard from you that the current contract mechanism we are using for manufactured food inspections may not be a feasible model for preventive controls inspections for many states. Some of you have suggested that a cooperative agreement model may be more appropriate. I don’t have an answer for you today on what might be possible, but rest assured that we are carefully exploring our options and the best model to use going forward and look forward to discussing this with the NASDA-FDA Leadership Group later this year.
FDA-USDA Formal Agreement
Turning to FDA’s formal agreement with USDA. Over the last few months, I’ve seen steady progress in reaching our shared goals. There are also several new steps we are taking that I would like to share.
Many of you were at the White House yesterday and witnessed the signing of a new formal agreement between the United States Department of Agriculture and the FDA that I mentioned at the outset of my remarks.
As you heard, the Secretary and I have worked closely and identified several areas where we can strengthen our collaboration to make our processes more efficient and predictable, potentially lowering costs to industry; while also strengthening our efforts to ensure food safety. Key areas of collaboration will include work on dual-jurisdiction facilities, biotechnology, and produce safety.
I would like to take a few minutes to highlight the activities we plan to conduct under the produce safety components of the agreement. We already have a long history of collaboration with USDA in the produce safety space. Even before passage of FSMA, we collaborated with USDA on produce safety research and the development of industry guidance on the safe production of particular commodities like melons and leafy greens.
Since the passage of FSMA, FDA has worked with USDA throughout the development of the produce safety rule, and USDA was part of the review process for the rule.
USDA’s extensive research operations have produced valuable information that have informed our standards development. FDA is keenly interested in continuing collaborations with USDA scientists to further our work in understanding the mechanisms by which food contamination occurs as well as helping us to answer challenges we are currently facing on issues like agricultural water and soil amendments.
FDA and USDA are also actively engaged in a number of training activities geared towards small and very small farms and small food processors and wholesalers. These efforts include the Produce Safety Alliance and the National Coordination Center and its four regional centers established with the USDA National Institute of Food and Agriculture. FDA and USDA also co-lead the FSMA Collaborative Training Forum, which provides an opportunity for dialogue between agencies, centers, associations, and others involved in produce safety training to ensure that size- and community-appropriate training is available to farmers.
The agreement signed yesterday signals our interest in continuing and strengthening this great work. In addition, Secretary Perdue and I have had some initial conversations about further steps we can take under the formal agreement in the produce safety space.
The first area we have discussed is one that we have also discussed with NASDA several times, and that relates to training cooperative extension agents on the new produce safety standards. As I stated earlier, we know that cooperative extension agents need training to effectively provide education and technical assistance to farmers. The task before us now is to conduct that training quickly so that extension agents have the knowledge they need.
At the training workshop we held in December 2017, we identified that Cooperative Extension agents may need a better understanding of the nature of regulatory inspections. This is an understandable gap considering we’ve not regulated farms/growers previously. We asked the participants for feedback on what formats might be most appropriate, and heard that cooperative extension agents do not need the full set of resource-intensive trainings that inspectors are required to take, but they do need a thorough understanding of what to expect when an inspector arrives at the farm.
Secretary Perdue and I are committed to working together to quickly develop appropriate training materials and use USDA’s infrastructure with state cooperative extension to deliver this training in a manner that is as efficient and effective as possible – likely a webinar format.
A second area of work Secretary Perdue and I have discussed is an effort to harmonize USDA’s Good Agriculture Practices Audit Program. This work is well underway with the goal of aligning GAP audits with the produce safety rule, to the extent practical. These efforts are intended to serve as an additional mechanism that will help produce businesses meet the final FSMA requirements as efficiently as possible.
Finally, we are also discussing efforts under the formal agreement to further enhance the compliance of agricultural products imported into the United States with the new produce safety standards. We have held preliminary discussions with USDA about greater collaboration with the USDA’s Foreign Agricultural Service to provide outreach and information to foreign producers, regulators, and other relevant stakeholders on produce safety requirements. We are hoping to tap into FAS’s knowledge base to identify foreign producers, trade associations, regulators, and other stakeholders that need outreach and education on the new requirements. We believe that this could be particularly useful in countries where FDA does not have an overseas presence.
I believe these examples show how agreement not only formalizes ongoing coordination, but presents a great opportunity to expand those efforts through better integration and increased clarity to the agriculture and food processing sectors.
As I hope is evident from my interactions with you all over the past few months, I committed to strengthening FDA’s internal coordination and external partnerships related to produce safety activities and the farming community. As part of that commitment, I am very happy to announce that we will now have a high-level agency focal point for produce safety located in our Center for Food Safety and Applied Nutrition. He’s someone many of you know -- Jim Gorny. Jim not only has previous FDA experience but has also worked for the Produce Marketing Association and is well known to the produce industry. He knows FSMA very well, what it’s designed to accomplish in enhancing food safety, and the challenges associated with implementation of a rule as complex as the produce safety rule.
Jim will be instrumental in strengthening the bridge between FDA and our partners in both state government and the food industry. And, he will join others at FDA in working with you on the various issues on our shared agenda. Jim will start in his new role as Senior Science Advisor for Produce Safety on February 5th. I hope you’re as pleased as I am that he’s agreed to return to FDA and help advance our work on produce safety.
Finally, I wanted to let you know that we’ve taken two important steps today to strengthen our oversight of foods grown or produced in other nations. I fully understand that your state industry wants confirmation that there will be parity between domestically and internationally-produced products. While our compliance tools for imports are different from those we plan to use domestically, I want to stress our commitment to holding imports to the same high level of public health protection. The Foreign Supplier Verification Program I mentioned earlier is one of the tools in our toolbox. Foreign inspections are another tool.
Today, we are announcing some major steps forward on other tools we have been developing for this import toolbox. We are announcing our first recognition of an Accreditation Body under the voluntary Accredited Third-Party Certification Program established by FSMA. Accreditation bodies recognized by FDA have the authority to accredit the third-party certification bodies that will conduct food safety audits using FDA’s safety standards and issue certifications of foreign food facilities and the foods they produce for both people and animals.
These certifications will be used for two purposes. First, they will establish eligibility for participation in the Voluntary Qualified Importer Program, known as VQIP, that offers expedited review and entry of food for importers who achieve and maintain a high level of control over the safety and security of their supply chains. And second, they will require that an imported product be certified in certain circumstances to keep a potentially harmful food from entering the country.
With today’s announcement of the ANSI-ASQ National Accreditation Board (ANAB) as the first accrediting board to be recognized, we are moving forward in our efforts to ensure parity between domestic and foreign food producers.
We are also announcing that VQIP will be open for business starting today. This program is available for importers who go above and beyond what is required under FSVP to establish a high level of control over the safety and security of their supply chains. In addition to ensuring that foreign suppliers are meeting FDA safety standards, it will allow us to turn our attention to imported foods that present a greater potential risk to public health. I am confident that these new tools will amplify our oversight of imported products, and better focus on the most important risks.
The conversations we’ve been having are ones that must continue. They are collaborative, frank, and very productive.
We are committed to having more frequent communications with NASDA members and having regularly scheduled meetings with a small group of key decision makers, so that critical policy level issues could be discussed and solutions developed in a timely, tailored way.
We held our first meeting with FDA-NASDA Leadership Group in November of last year and we are actively working to schedule our next meeting in March. In November, we identified several high priority action items for follow up and FDA Leadership is working diligently on these issues. I provided our first direct communication to NASDA members in November and if NASDA members find this helpful, we will continue to provide this periodic communication.
The confidence we have in the safety of our food supply affects our day to day lives and choices in subtle ways that only become clear when we face a problem.
This administration is committed to sustaining consumer confidence and to a future in which smart measures are systematically taken to reduce the risk of foodborne illness without adding unnecessary burdens that don’t improve safety. From my conversations with you over the past few months, I know that you understand the challenge of providing Americans with safe, nutritious foods and that you are committed to our shared role in protecting public health. This is a role that impacts all of us – our families, our children, and our animals.
This is going to be a good year, thanks in no small part to your hard work. Together, we’re making our food supply safer for generations to come, and expanding America’s bounty for the world to share.