Implementation of the U.S. Food Safety Modernization Act: Building a Partnership for Prevention
Good morning. First, let me thank the conference organizers for inviting me to speak here, and thanks also to my colleagues in the Chinese government, who have given me and our entire FDA delegation a very warm welcome to China this week.
I’m pleased to be here on my fourth trip to China and third to Beijing, because every time I come to China I learn something new and gain new relationships, all of which I value greatly.
I am also delighted to again be part of this important gathering of the international food safety community. While we may differ in language, culture and economies, we are connected through the global marketplace, which makes it essential that we move forward on food safety together—regardless of where we call home.
Food Safety Modernization Act
My subject today is FDA’s implementation of the Food Safety Modernization Act, which I believe makes it more critical than ever that we move forward together on food safety.
When I spoke at this conference last year, before Congress passed our new law, I outlined the key elements of FDA’s food safety strategy. They included:
The need for food safety systems based on the food industry’s primary responsibility to prevent food safety problems,
The need for risk-based, prevention-oriented standards and stronger accountability for meeting them, and
The need for a global approach to food safety.
Now, the Food Safety Modernization Act makes this strategy the law of the land in the United States. And the new law, with the support of a broad coalition of consumer and industry groups, gives the Food and Drug Administration a strong mandate and new tools to implement the strategy.
This blueprint for change addresses the safety of imported foods in important new ways. In fact, the import safety provisions in our law make a fundamental paradigm shift – from primary reliance on FDA inspectors detecting and correcting problems at the port of entry—to making importers accountable for verifying that their foreign suppliers have adequate preventive controls in place. Importers must manage their supply chains.
FDA welcomes the new paradigm embodied in the Food Safety Modernization Act and the challenge of implementing it, in collaboration with the entire food safety community. We welcome the new law because it will be good for public health.
We also see in the new law a powerful vision of a food safety system that both achieves higher levels of assurance about the safety of food and does it more efficiently by harnessing the efforts of all participants in the food system in a partnership for prevention. This partnership is based on clearly defined responsibilities and strengthened accountability for taking steps we know can improve food safety.
Today, I want to talk about how the law’s major requirements relate to this vision, focusing on the preventive control mandates and the new framework for overseeing imported foods. I also want to talk about how we are proceeding with implementation, and how you can participate in this process. And please rest assured that there is plenty of time to participate in shaping our new food safety system through the rulemaking process we’ll soon start.
As we proceed with implementation, and with defining responsibilities and accountability under the new law, two principles stand out loud and clear.
The first principle involves striking the right balance between specificity and flexibility as we develop regulations to implement the law’s requirements. On one hand, we must establish requirements with enough specificity to ensure that we meet our goal of a safer food supply and that companies know what to do. On the other hand, if we are too specific, our plans may work on paper but not in the real world, where flexibility is needed to address diverse commodities and production practices and the different risks that they pose. So achieving the right balance between specificity and flexibility is critical to our success.
The second principle is the need to consider the law’s requirements not just individually but as parts of a whole. It’s easy to list the various requirements as separate parts and miss the interrelationships—the intersections. In particular, the preventive control provisions must work hand in hand with the import provisions to create a food safety system that takes a global approach to preventing food safety problems.
Prevention is, of course, the cornerstone of the new law, and Congress has recognized that prevention is a shared responsibility of all participants in the food system – from growers to processors to shippers and retailers. The law recognizes as well, however, the differences between facilities that manufacture or pack food and feed, and farms that grow produce.
Facilities that process food and feed will be required to establish modern preventive controls that are consistent with internationally recognized principles of Hazard Analysis and Critical Control Points (HACCP).
Preventive controls, of course, are not new—FDA already requires such controls for seafood, eggs and juice, for example. And many companies have preventive controls of their own in place. But the law gives FDA an explicit mandate to make the use of this modern approach to food safety the norm across the food supply.
Farms that grow produce also must take a preventive approach, but because of the nature of these operations, the preventive controls will be different from those in facilities that manufacture food. To address the specific food safety problems with produce, the law requires FDA to set science- and risk-based standards for the safe production and harvesting of fruits and vegetables, addressing such areas as water quality, employee hygiene, soil amendments, and animal intrusion in growing fields.
The importance of such standards for produce is well recognized in the United States. We have had several significant produce-related illness outbreaks in recent years, most recently the one related to cantaloupes. No country is immune to the possibility of an outbreak. We believe that setting science-based standards for produce, and working closely with growers to implement them, will reduce this risk.
Foreign Supplier Verification Program
Let me turn now to the new law’s import requirements, which are closely tied to the preventive controls and produce safety requirements. Our Congress has recognized that food importers and private sector supply chain management must play an important role in the food safety system. Specifically, our new food safety law requires every food importer to establish a risk-based Foreign Supplier Verification Program to provide documented assurances to FDA that the food they are importing has been produced under preventive control systems that provide the same level of protection as the systems that U.S. firms will be implementing.
Having preventive control requirements apply to both domestic and imported products is important for food safety and for consumer confidence. In the U.S., approximately 15 percent of our food supply is imported, including 80 percent of our seafood, 50 percent of fresh fruit, and 20 percent of our vegetables. A credible, consistent approach to food safety is essential in a global marketplace.
Together, these closely interconnected requirements –preventive controls for facilities and farms and the requirement that importers verify that products entering the U.S. comply with the preventive controls – establish the central core of the regulatory framework envisioned by FSMA.
Third Party Certification
The Foreign Supplier Verification program is a central element of the new import safety system envisioned by Congress, but it is part of a larger tool kit for import safety that includes FDA conducting more foreign inspections and working closely with foreign governments to strengthen food safety oversight. Congress has also recognized the important role already being played in the international arena by private sector third-party audits. Congress and FDA recognize that some of these audits are rigorous and add significant food safety value—and that some do not. To build on the strengths of this private effort, Congress has given FDA a mandate to establish an Accredited Third-Party Certification Program.
Under this program, FDA will recognize accrediting bodies and set standards for accreditation of private third-party auditors that will help ensure the rigor, objectivity and transparency of privately conducted audits. Transparency means that the audit results will be available to FDA, which in turn means that we can rely on private audits as part of the public system of assurances and accountability for food safety.
FDA sees the Accredited Third-Party Certification Program as central to the vision of a system that provides significantly elevated assurances about the safety of food moving in international trade in a more efficient way.
In fact, by capitalizing on private sector food safety efforts and linking them to the public assurance system, we think accredited third-party certification can help transform the way we ensure the safety of globally traded food. And we think this kind of partnership for prevention is in the best interest of both consumers and the food industry.
In our vision of the future, we do not see private audits replacing public oversight, but rather helping ensure that we make the best, most efficient use of both public and private resources to produce a safe food supply.
So, big change is coming in the U.S. food safety system, but it will not happen overnight. The new preventive control standards and import provisions I’ve outlined here must be implemented through a public rulemaking process. This process takes time, but is crucial to ensuring we get the rules right based on input from all of our stakeholders.
It is through this public process that we will make good on the two principles I outlined at the beginning of this talk – achieving the right balance between specificity and flexibility, and being sure all the pieces of the new law fit together as a practical whole that can work in a complex and diverse global food system.
We have many rulemaking mandates in the new law, but we are prioritizing the ones I have discussed today – preventive control standards for food and feed facilities, produce safety standards, foreign supplier verification, and accredited third-party certification.
In the coming months, we will be publishing proposed rules and inviting public comments. We take this rulemaking process very seriously, and we hope you will take advantage of the opportunity to comment on our proposals. We will carefully review your comments and take them into account in making final decisions about our rules.
With a law like FSMA that has international trade implications, notice is also sent to the World Trade Organization so that international stakeholders are made aware of proposed and final rules. We will, of course, fulfill our WTO notice obligations, which provide another chance for foreign governments and other stakeholders world-wide to provide comments.
I want to emphasize that, even after we issue final rules over the next year or so, we will be allowing additional time for firms to come into compliance. We are committed to devising a compliance schedule that ensures as much as possible an orderly, feasible transition to the new system.
For certain final rules, we will also prepare guidance documents to help industry comply with the requirements. One of the keys to success of the new system will be industry outreach and education, as well as technical assistance, especially for small-scale growers and processors. We intend to work closely with the industry and our federal, state and foreign government partners on this phase of implementation.
So, you can see that implementation of the Food Safety Modernization Act involves much more than issuing new regulations. It involves working in partnership with our many stakeholders over the coming years. This is important not only to get the standards right, but to facilitate the high rates of compliance that are the key to food safety and consumer confidence.
Stakeholder outreach has been a critical part of our implementation process so far and will continue to be crucial in the future. It is a way to get input above and beyond the formal rulemaking process. Even before publishing proposed rules, we have held public meetings, made hundreds of presentations, received written input, and visited farms and facilities to learn first-hand about the diversity of operations. We also have developed an interactive web site at www.fda.gov/fsma, where the latest news on implementation is available.
Our outreach to regulators and industry has been global in its scope. In addition to briefing the embassy community in Washington, we’ve met with our regulatory counterparts in Canada, Mexico, the European Union and, of course, China, as we will do again tomorrow. We’ve also conducted about 75 outreach activities world-wide, with about 10 in China alone.
We are committed to continuing this outreach. So, stay tuned, and take a look at our web site, which has translations of many of our outreach materials.
In closing, I just want to say again how much I appreciate the opportunity to be here today to share with you some of the important work underway to implement the Food Safety Modernization Act.
The challenge is great but so, too, is the opportunity to strengthen food safety and the global food system. We will succeed if we work together, if we build a true partnership for prevention, and if we sustain our effort for the long term. FDA is committed, as I know you are, too. So we look forward to the days ahead.
Thank you and best wishes for a successful conference.