Joann Givens, left, is the Acting Regional Food and Drug Director (Central Region) in FDA’s Office of Regulatory Affairs and Roberta Wagner is the Deputy Director for Regulatory Affairs in FDA’s Center for Food Safety and Applied Nutrition.
Roberta Wagner and Joann Givens are co-leads of the Phase 2 FSMA Implementation Team Steering Committee, charged with establishing multi-year strategies for gaining widespread industry compliance with the rules mandated by the FDA Food Safety Modernization Act once they become final. They oversee the work of four teams—Preventive Controls, Produce Safety, Import Controls, and Intentional Adulteration. These teams have been working for the past 18 months on establishing FSMA implementation strategies and plans for the rules in the following target areas: industry and regulator education; outreach; technical assistance and training; inspection, compliance and enforcement; information technology; and performance and public health metrics.
Since January 2013, FDA has proposed seven rules to implement preventive and risk-based standards for the growing, harvesting, packing, processing and distribution of domestic and imported food for people and animals, from farm through transportation to retail. FDA expects to publish final rules for preventive controls for human and animal food in August 2015, with the final rules for produce safety, and two import-oriented final rules following in October. FDA expects to publish final rules on sanitary transportation and intentional adulteration in March and May 2016, respectively.
In May 2014, FDA released an operational strategy and guiding principles for implementing the foundational FSMA rules and on April 23-24, 2015 that strategy will be the focus of a national public meeting in Washington D.C.
As the public meeting date approaches, Wagner and Givens share their insights on what FDA is doing to prepare for FSMA implementation.
Q: The rules don’t start becoming final until later this year and there is a year or longer before they take effect. Why are you working on implementation this early?
Wagner: Lives are endangered every day by preventable foodborne illnesses, so we must be ready to implement these rules as soon as they take effect. We will publish seven final rules later this year and in 2016. It may seem like we’re starting early, but in reality, we’ve got to get going. Overseeing industry compliance with seven new regulations— essentially at the same time—is practically unheard of and has, and will, continue to take a tremendous effort by many in FDA’s foods and feed program. This work involves the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA), in addition to our state partners. We have to build the implementation network and infrastructure.
Givens: The states have an important role in FSMA implementation—both in helping to educate industry and in conducting inspections on FDA’s behalf—and this requires that we interact with 50 states, and often multiple agencies within each state. We’re trying to be inclusive as we move forward and make decisions on implementation, and that takes a lot of time and effort—but it is worth it. Industry expects consistent approaches to regulatory inspections. To be successful, FDA and the states must develop the inspection strategies together. Also, we want to have our FDA and state investigators and food safety staff well trained in preparation for implementation. Bottom line: We don’t feel that we’re far ahead.
Q: FDA has recently said it is changing the way it operates so that it can better implement FSMA. Can you give some examples?
Wagner: One major example is promoting more direct and frequent communication between field investigators and inspectors and Center subject matter experts, enabling them to work as a team and, as appropriate, communicating with the food industry as a team. I was in the field for 20 years, and Joann has been in the field even longer and is there now. Historically, investigators have not been encouraged to reach out directly to the Centers—to just call an expert without going through a supervisor, compliance officer or ORA headquarters for that matter. There will be the opportunity for investigators and inspectors to get real-time technical and scientific support or assistance before, during or after inspections without having to go through intermediaries. For everyone, that will be a huge change. We recognize too that, domestically, we really have an opportunity to develop federal and state (integrated) inspection programs and data strategies for a variety of these rules—from the start as opposed to trying to integrate disparate approaches after the fact. Right now we do have state representatives at the table with us developing inspectional strategies for the FSMA rules so that we can promote a consistency in inspections conducted by regulators—a must-have for the industry. It’s been challenging, but that’s what we’re trying to achieve.
Givens: The degree to which we’ve engaged external stakeholders is unprecedented. I’ve never seen operations people meeting with industry and consumer groups the way we have been doing, making presentations and getting feedback from these stakeholders. And we’re taking their feedback very seriously. We’re going to invest more up front in education and outreach. We have to develop the infrastructure to do this—as we plan, it’s being built.
Q: What kind of resources will FDA be providing for industry and federal/state regulators?
Wagner: Relative to industry and regulators alike, we are and will continue spending a lot of time writing and issuing industry guidance documents. We recognize that the rules are written in a very flexible way—they’re not overly prescriptive—so there will need to guidance documents and other materials so that agency expectations are clear. The day-to-day relationship between FDA and state field investigators and inspectors and Center subject matter experts will be critical in meeting our food safety goals while we’re developing the aforementioned guidances and other tools.
Givens: We’re also going to train the regulators differently. Training on the new standards and how to inspect the industry to determine compliance with these standards will no longer include just one classroom training opportunity. There will be continuous training for federal and state regulatory personnel, including periodic technical updates regarding industry best practices. And we want the investigators and inspectors to understand that we will also support them by offering refresher training, coordinating joint inspections with more experienced staff, through mentoring programs and anything else we can do to support them. Industry will be trained on the content, requirements, and how to comply with the FSMA rules though public-private partnerships that FDA supports, including the Preventive Controls Alliance, the Produce Safety Alliance and the Sprouts Safety Alliance.
Q: Once the rules are final, will there still be opportunities for stakeholders to have a voice in how they are implemented?
Wagner: We’re going to be in a continuous learning mode as we roll out our industry oversight strategies and implement these rules. We are going to monitor and evaluate our oversight strategies to determine if we are achieving desired results—for example, widespread industry compliance with the FSMA rules. If we are not achieving the desired results, we will tweak our oversight strategies, perhaps pilot different approaches. I can say we rarely invest resources in assessing whether our implementation strategies are working. For FDA, this is a very new way of doing business.