Remarks at the Global Food Safety Conference
February 16, 2012
Michael R. Taylor
Deputy Commissioner for Foods
U.S. Food and Drug Administration
First, let me thank the conference organizers for inviting me to speak here today. I’m pleased to be able to continue the dialogue that my colleagues and I had with GFSI in London last year, and in other settings since then with GFSI’s executive board and members.
GFSI and Industry Leadership
The Global Food Safety Initiative is a critically important leader on food safety. For over a decade, GFSI has been advancing food safety by acting on one key idea, which is that the fundamental basis for food safety in today’s global food system is active food safety and supply chain management by the food industry.
I’m going to update you on what the government is doing to improve food safety – and public confidence in food safety – through implementation of the Food Safety Modernization Act (FSMA). But it all starts with what the food industry does every day in ensuring that modern food safety procedures are applied in their own facilities and in those of their suppliers to prevent food safety problems.
FSMA recognizes the primary responsibility and capacity of the food industry to make food safe. It also spells out the essential and complementary role of government. FSMA directs FDA to build a new, modern food safety system that includes a level playing field of standards all must follow for preventing food safety problems and a multi-faceted tool kit for gaining high rates of compliance with those standards.
That’s how we’ll make food safer. And that’s how we’ll build public confidence in the safety of the food supply: modern standards and documented assurances that those standards are being met.
Collaboration as a Key to Success
Another key theme of the Food Safety Modernization Act is collaboration. FSMA contains some 50 specific directives for FDA to collaborate with other federal and state agencies and foreign governments in the design and implementation of the new food safety system. It also calls for collaboration with the food industry in getting the standards right and providing assurances that the standards are being met.
It is in the spirit of collaboration that we at FDA have invested much time and energy over the last year in outreach to the food industry and other stakeholders to gain input prior to proposing rules for implementing FSMA. And it is in the spirit of collaboration that I am here today, with a focus on the role public-private collaboration – and particularly accredited third party certification – can play in providing the food safety assurances consumers seek.
We’ve discussed this topic before, but our dialogue is about to reach a critical new phase as FDA moves down the pathway of implementing FSMA. We will soon be publishing proposed rules that will establish the basic regulatory framework for the new food safety system, as it will operate with respect to both domestic and imported food. This means we will be getting down to some of the crucial details of how FSMA will work in practice.
To facilitate our collaboration in getting the rules right, I’ll briefly review the five highest priority framework rules, so you can be prepared to provide further input. I’ll also flag some of the challenges we must work on together to fulfill the promise of accredited third-party certification.
Key FSMA Framework Rules
Three of the forthcoming proposed rules relate to establishing the basic regulatory framework for prevention that Congress mandated 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 feed facilities.
Farms that grow fresh 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. The produce safety rule will 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 challenge is to devise rules that target the practices most likely to introduce hazards and that are flexible enough to be feasible and effective across the great diversity of crops, hazards, practices and growing conditions in the produce sector. This is not easy to do, so we look forward to robust comments on the proposed rule.
The law’s new import requirements are closely tied to the preventive controls and produce safety requirements and call for a fundamental paradigm shift. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, 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. In short, importers must manage their supply chains to ensure the safety of imported foods.
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 what FSMA calls 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 in the next several weeks.
Accredited Third Party Certification
The fifth rule we have prioritized in implementing FSMA addresses accredited third-party certification, which is a central example of FSMA’s focus on public-private collaboration.
The Foreign Supplier Verification Program makes private sector supply chain management the foundation of the import safety system, but Congress has also recognized the important role already being played in supply chain management by private sector third-party audits and certifications. Like GFSI, Congress and FDA know that rigorous, objective private audits can add significant food safety value and thereby complement oversight by public regulators. But we also recognize that rigor and objectivity cannot be taken for granted.
That, of course, is part of the motivation for the pioneering work GFSI has done to strengthen the private audit system. And Congress has given FDA a mandate to build on this work by establishing an Accredited Third-Party Certification Program.
Under this program, FDA will recognize accrediting bodies and set standards for accreditation of third-party certification bodies and auditors aimed at ensuring the rigor, objectivity and, most importantly, the transparency of third-party audits. Transparency means that the results of audits for certification will be available to FDA, which in turn means that we can both assess the rigor of private audits and rely on them as part of the public system of assurances and accountability for food safety.
The Accredited Third-Party Certification Program is central to FDA’s vision of a system that provides significantly elevated assurances about the safety of food moving in international trade in a more efficient way. We think a framework that enhances the public credibility of third-party audits can both help satisfy FSMA’s foreign supplier verification requirements and contribute to streamlining the current private audit system.
We all know about the distractions and costs involved when a single facility is subject to multiple, often redundant audits. In our complex food system, there will likely continue to be demands on suppliers for audits coming from different directions and for different purposes.
But, as we move toward globally harmonized safety standards and well-recognized procedures for verifying that those standards are being met, we should be able to reduce the number of food safety audits that are needed.
We at FDA are eager to see how our foreign supplier verification and accredited third-party certification programs can contribute over the long haul toward a global food safety assurance system that is both more effective and more efficient. We think a system like that – a real partnership for prevention – is in the best interest of both consumers and the food industry.
I want to emphasize, of course, that in our vision of the future, we do not see third-party audits – even those conducted under FDA’s program – totally replacing direct regulatory oversight. We are on a pathway to strengthened partnerships and we want to rely on the efforts of others, but appropriate government oversight of importers and foreign facilities will continue to be critical for a number of reasons, including to establish and maintain the credibility of the new certification program.
As we build our new import system, we want to work closely with GFSI and build on the foundation you have established for effective and credible certification programs. I know that GFSI and its members have a strong commitment to continuous improvement, as clearly reflected in the sixth edition of the GFSI Guidance Document, released in January 2011. The technical working groups you have assembled are tackling many of the most important topics that FDA faces in developing its third-party program.
And some challenging issues lie ahead, especially regarding auditor competence and capacity:
What is the right level of training and experience for an accredited auditor?
How much specialized knowledge do they need to demonstrate competence?
What are the most predictive measures of auditor competence?
How many qualified auditors will eventually be needed, in what disciplines, and in what geographic areas?
What can be done to attract qualified auditors by establishing solid career paths? And who is best situated to drive this discussion?
What is the role of the accredited certification body in assuring the competence of auditors?
How do we build an adequate cadre of qualified auditors with the wide diversity of operations that comprise the global food system?
We also must address and be constantly vigilant regarding the independence and objectivity of private certification bodies and auditors. A credible audit asks the hard questions and analyzes the data from a neutral perspective, with one purpose: to objectively assess compliance.
What incentives and controls are needed to achieve this goal?
How do we avoid the perception or reality of conflicts of interest?
What role should accrediting bodies play in monitoring and assuring the objectivity of certification bodies and auditors?
We think the transparency feature of FSMA’s accredited third party program can contribute significantly to the credibility of private audits, but:
What information from audits should be provided to FDA?
How can FDA best use this information to verify the integrity of the audit system, inform the industry of emerging issues and trends, and improve the targeting and effectiveness of FDA’s food safety efforts?
And, what information should be made public?
Finally, how should FDA structure its relationship with recognized accrediting bodies? These organizations will play a crucial role in an accredited third party certification system, but:
What attributes must they have to be successful?
Are there thresholds of expertise, experience and capacity that must be reached to be recognized by FDA as an accrediting body?
Once recognized, how should accrediting bodies be overseen by FDA and held accountable for the rigor of their accrediting activity?
These are just some of the difficult challenges and issues we must tackle together. The next big opportunity for engagement on these issues will come in the spring, when we hope to publish and invite comment on the proposed rule establishing the framework for FDA’s accredited third party certification program. I know we can count on GFSI’s close scrutiny and detailed comments on this rule.
But our collaboration will have to go well beyond the rule. Many of the challenges involve institution and capacity building. They go beyond anything FDA can address in a regulation. They are about constructing the basis for a new, global food safety system that works better for both consumers and the food industry.
We need to be collaborating on all these fronts for years to come.
So, thanks again to GFSI for inviting me to speak today.
The challenge of implementing the Food Safety Modernization 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, and if we sustain our effort for the long term. FDA is committed, as I know you are, too. So we look forward to working with all of you.
Thank you and best wishes for a successful conference.