Editor's note: Michael R. Taylor is the Deputy Commissioner for Foods in the U.S. Food and Drug Administration. The following is the speech he gave on March 22, 2012 at the America Trades Produce Conference in Tubac, Ariz.

Good morning. It’s a pleasure to be here today with Octavio Carranza to talk about the FDA Food Safety Modernization Act and what it means for domestic producers as well as for importers.

A number of FDA staff are here with me—Jim Gorny, Phyllis Marquitz, and Domenic Veneziano—which illustrates how important we believe it is to maintain a dialogue with you as we proceed with FSMA implementation.

While FSMA is “top of mind” for us in the U.S., we are aware that Mexico has a new legislative mandate that addresses the certification of good agricultural practices. So we want to learn more about that and continue the dialog so we can learn together and grow together. In fact, we are finalizing a food safety arrangement with Mexico that affirms our commitment to keep lines of communication open.  This arrangement re-institutes and revitalizes a former food safety arrangement with Mexico, which was signed by the secretaries of Agriculture and Health for both the United States and Mexico. We are looking forward to finalizing and signing the new arrangement, which will provide a framework for ongoing food safety communication and collaboration with Mexico on food safety.

Key FSMA Framework Rules

Today, I will provide an update on the foundational proposed rules that establish the basic regulatory framework under FSMA. Three of the forthcoming proposed rules require preventive controls for those who grow and pack fresh produce and process food and animal feed. 

While Congress recognized that prevention is a shared responsibility of all participants in the food system, it also recognized the differences among facilities that manufacture or pack food and animal feed, and farms that grow produce. That is why we are proposing three separate rules to establish the basic framework of prevention standards. 

Facilities that process human food will be required to establish modern preventive controls that are consistent with internationally recognized principles of Hazard Analysis and Critical Control Points (HACCP) and address supplier verification activities that relate to the safety of food. Congress used some different terms in mandating preventive controls in all types of food facilities, but these proposed rules will seem familiar to those who are currently following Codex principles and guidelines for HACCP. 

Animal feed facilities are also subject to the preventive controls mandate but will be addressed in a separate but similar rule that takes into account some differences in how preventive controls would work in human and animal food facilities.  

Produce Safety Rule

I know that the produce safety rule is of most interest to this audience, and I want to emphasize that his rule was created with full consideration of the international framework under which we operate. The United States is a key participant in Codex Alimentarius—as is Mexico—and our proposed rule on produce safety is closely aligned with the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables.  

Farms that grow fresh produce 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. The produce safety rule will set science- and risk-based standards for the safe production and harvesting of fruits and vegetables. The rule focuses on five familiar potential routes of contamination: worker health and hygiene, agricultural water, soil amendments, animal intrusion, and buildings and equipment.  At one time or another, all of these routes have been identified as potential contributing factors in produce related outbreaks.  They represent the core of the long-standing Good Agricultural Practices program. So focusing farmers and packing house operators on both sides of the borders on these key areas will simplify the message of what it takes to safely produce these crops and reduce illness.

The challenge is to devise rules that target the practices most likely to introduce hazards but that also are flexible enough to be feasible and effective across the great diversity of crops, hazards, practices and growing conditions in the produce sector.  We recognize the need to maintain consumer access to a wide range of imported foods while minimizing to the extent possible added costs and disruption of trade. 

We are sensitive to this and for that reason, are imposing new requirements only when they are relevant and necessary for the safety of a crop. And we have built in flexibility in several ways. We are proposing that farms be able to use alternative practices as long as they are based on sound science.  

Foreign Supplier Verification Program

The fourth proposed rule addresses import safety, and it is closely tied to the preventive controls and produce safety requirements. The proposed rule on Foreign Supplier Verification calls for a fundamental paradigm shift. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, importers must manage their supply chains to ensure the safety of imported foods. FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with U.S. standards, or under modern preventive controls that provide the same level of public health protection.  

This new import paradigm is grounded in public-private collaboration. FDA sets safety standards and will provide a certain level of oversight through a continuing presence at the border and a stronger presence overseas. But much of the assurance that imported food safety standards are being met will come from the importer carrying out a Foreign Supplier Verification Program. The fourth rule FDA is working on will lay out how importers can meet this new requirement. 

Having preventive control requirements apply to both domestic and imported products is, of course, essential for food safety and for consumer confidence in today’s global marketplace, and it will require real collaboration between government and industry to achieve that goal.

Together, these closely interconnected requirements –preventive controls for facilities and farms and importer verification that imported food meets U.S. standards – establish the central core of the regulatory framework envisioned by FSMA. The four proposed rules establishing this framework are in the final stages of review and should be published for public comment soon.

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. So following closely behind is a proposed rule on third party certification. 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. 

Partnering with Mexico

As we move forward with FSMA and in particular our new import system, we place a high priority on partnering with Mexico. This partnership is critical in maintaining consumer confidence in the safety of imports and is critical to ensuring the successful implementation of the Foreign Supplier Verification Program and third party certification.

Our partnership began more than 10 years ago with a 2001 Pilot Program on Good Agricultural Practices in Sinaloa.   Since then FDA and our academic partner JIFSAN have held eight Good Agricultural Practices workshops in Mexico—more than in any other country. Numerous technical experts have shared their knowledge in areas such as laboratories, seafood and dairy processing, and food packaging. FDA has hosted 40 visitors in 14 delegations to facilitate information exchange between our countries.

Just since FSMA was enacted, we have carried out or have planned more than 30 outreach activities in Mexico. Our FDA office in Mexico City just recently spent a week in Guadalajara, two days in Puebla and one day in Mexico City talking about various import requirements and how to participate in FSMA. I led a delegation last June to meet with Mexican food safety officials in Mexico City. The input we receive at these events is invaluable.

We have number of ongoing activities and initiatives to support this partnership. For example:

•  We completed 131 inspections in the last year in Mexico, many of them in collaboration with the Mexican government. We currently have a temporarily stationed inspector in Mexico conducting inspections simultaneously with SENASICA.
•  We recently hosted a team of laboratory staff from SENASICA at our New York district office so they can learn about analytical methods, and we have translated certain methods into Spanish. We have also conducted pilots to share the results of certain laboratory samples collected at the border with the Mexican government in real time.
•  We're working with industry and COFEPRIS and SENASICA to develop a mapping project to capture in one place the supply chain of fresh produce sectors. We are starting with papaya and mango and will continue with other commodities.
•  We’ve held sessions for industry on FSMA, registration and prior notice, import alerts and refusals, Good Manufacturing Practices and Good Agricultural Practices.  

And last year, we broke new ground in outbreak response when FDA and its two counterpart agencies in Mexico collaborated on the outbreak of foodborne illness attributed to papayas. This was the first time we had such a high level of engagement and collaboration so early in the process with the exporting country. FDA and Mexican officials conducted a joint inspection of a grower, and Mexican officials stepped up efforts to trace the source or sources of contamination and to develop methods for preventing these problems in the future. Additionally, we collaborated on laboratory methodologies for testing fresh papayas for Salmonella.

These specific initiatives and ongoing communication, along with the Food Safety Arrangement I mentioned earlier, illustrate our real commitment to partnering with Mexico to ensure food safety. Our collaboration is a work in progress that will require sustained commitment and investment on both sides, and the United States is committed to this effort.

Rulemaking Process

This strong partnership will be extremely beneficial as we implement the FSMA initiatives I have laid out today. These changes will not happen overnight, of course. They 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 ensure we have achieved the right balance between specificity and flexibility. And it is through this public process that we ensure that all the pieces fit together as a practical whole that can work in a complex and diverse global food system. 

We hope that 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. We will, of course, also 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. 

Outreach and Technical Assistance

We also will continue stakeholder engagement—which has been a key part of our implementation strategy. The extensive outreach we have already conducted in Mexico over the past decade sets the stage for continued interaction. 

Once the foundational rules are published, we will hold another set of public meetings to engage stakeholders. And we will continue our outreach both domestically and internationally. Our goal is to get the best input we can on our proposed rules.

As we move forward with final rules, we also will provide technical assistance both domestically and internationally and will work closely with the industry and our federal, state and foreign government partners on this phase of implementation. We will provide training through Alliances we have established for produce, sprouts, and preventive controls and through the Joint Institute for Food Safety and Applied Nutrition. 

Closing

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 we have underway and to hear from you as well. 

Food safety is a great challenge, especially in a global environment. 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 continuing to work with you.