China International Food Safety and Quality Conference and Expo
November 5, 2014
As prepared for delivery by
Michael R. Taylor
Deputy Commissioner for Foods and Veterinary Medicine
U.S. Food and Drug Administration
I want to begin by thanking our Chinese colleagues and the conference organizers for inviting me once again to this beautiful city and this important food safety conference. This city and this conference epitomize the international dimension and the spirit of partnership that I believe characterize today’s food safety landscape. The food system grows more global and trade-driven every year, which means we grow more dependent every year on collaboration and real partnership, between government and industry and across national boundaries.
The truth of this from the vantage point of the United States is demonstrated by a few numbers. Overall, 15 percent of our food supply is imported from other countries, but this includes 80 percent of our seafood, nearly 50 percent of our fresh fruit, and 20 percent of our fresh vegetables. And last year, the U.S. exported a record $136 billion in foods, feed and beverages.
These numbers reflect consumer demand for a diverse and economical food supply year-round and the compelling economic logic of the global food system. But underlying these numbers is the strong and persistent expectation of consumers that the foods they buy will be safe, no matter where the food comes from.
Meeting that expectation is why the Food and Drug Administration has done so much over the last decade to elevate its international food safety presence and activity, and it’s why I spent the last two days in Beijing meeting with FDA’s food safety counterparts in the Chinese government as part of our continuing effort to strengthen understanding and collaboration between our food safety regulatory systems. We consider this ongoing dialogue between the United States and China to be crucial for enhancing food safety, public confidence, and trade between our countries – goals I know we all share.
It is fitting that I conclude my visit to China with this great conference, which brings together the diverse, global food safety community, from both public and private sectors. I often say that government doesn’t make food and government can’t make it safe. Instead, as everyone in this audience certainly understands, responsibility for food safety rests first and foremost with the food industry -- those who grow, process and market food. That is why you are here, and that is why my fellow regulators and I are here. We all have crucial roles to play on food safety, and we need to work together to be successful.
In that spirit, I want to take a few minutes to review the food safety paradigm we are implementing in the United States, the change it is requiring in how we at FDA do our work, and how our new paradigm affects our collaboration with the food industry and foreign governments.
FSMA’s Prevention Paradigm
The food safety paradigm under which FDA is operating is mandated by the Food Safety Modernization Act (FSMA) of 2011, and it is a familiar one to the international community. After all, the new U.S. food safety law is based on widely accepted international norms and practices that have been adopted by Codex and are being pursued by many other countries.
The paradigm is simple. We will achieve the best food safety results if we define in workable, science-based standards the approaches to managing food safety systems that we know are effective in preventing food safety problems AND if we achieve high rates of compliance with those standards.
Harnessing this paradigm to prevent foodborne illness is what FSMA mandates FDA to accomplish, in partnership with the global food safety community. And, if we are successful, we will have accomplished our goals of protecting food safety, strengthening public confidence, and facilitating trade in safe food.
FSMA’s Prevention-Oriented Standards
We are addressing the first element of our food safety paradigm by developing seven major regulations, including ones addressing produce safety on farms, preventive controls in all food and feed facilities, and the food safety obligations of importers. These four most significant rules will be finalized in late 2015, with the obligation for industry to comply envisioned to begin in late 2016.
These rules will establish the critical regulatory framework for prevention of foodborne illness. They will be flexible and adaptable to the wide diversity of food operations we regulate. They will place a strong emphasis on the grower, packer, processor and importer understanding the hazards in their operations and implementing the measures that are effective to prevent or minimize them. These rules, backed up with guidance, educational materials and technical assistance, will make clear FDA’s expectations for how industry can meet its food safety responsibilities under FSMA, and they will create the regulatory basis for ensuring there is real accountability for prevention.
Achieving High Rates of Compliance in a Culture of Prevention and Verification
While the conceptual framework is familiar and widely accepted in the food safety community, we all know that concepts and rules don’t by themselves improve food safety. What matters is how they are implemented – how we together, as a food safety community, achieve high rates of compliance with food safety standards and are able to assure ourselves and consumers that we are doing everything we reasonably can to make food safe.
This is the essential second element of our food safety paradigm. It’s about high rates of compliance with food safety standards, but it’s about more than just complying with regulations in a formalistic way. It’s about building throughout the food system a food safety culture:
- that wants to know what the hazards are so they can be prevented,
- that makes the business of food safety a central element of the business of making food, and
- that is able to verify internally and for the public that food safety is being protected.
Many farms and firms we regulate have had strong food safety cultures for years. Many are building them today, while many have a long way to go. FDA cannot create food safety cultures in food companies. That’s up to them. What we can do is verify that standards are being met, which, under FSMA, is a shared responsibility of government and industry. And we can incentivize and reward strong food safety cultures by the way we conduct our inspection and verification work.
The Congressional Vision
In enacting FSMA, our Congress very much recognized verification as a central element of the prevention paradigm and assigned both industry and government important roles. For example:
- Verification is built into the preventive controls framework for food processors,
- Verification is a new responsibility of importers,
- FDA has new inspection powers and mandates aimed at verifying compliance with FSMA’s standards, and, very importantly,
- Congress directed FDA to collaborate with our government partners in the United States and around the world to verify that food safety standards are being met.
FSMA’s heightened focus on verification is by no means just a U.S. phenomenon. Its importance is recognized in Codex standards, in the regulatory and certification activities of many of our trading partners, and in the rapid advancement of private sector supply chain management practices in recent years.
Opportunities for Collaboration and Progress on Verification
So, one of the most important questions we are grappling with at FDA is how we can enhance our role in verification and strengthen our public and private partnerships to better assure consumers that our food safety systems are working.
We see great opportunity for enhanced collaboration on compliance and verification both within the United States and internationally. Let me close with a few examples.
First, in our domestic inspection and compliance program, our focus will be on achieving and verifying that private food safety management systems are working effectively to prevent problems. This is a shift from our historic focus on enforcement of adulteration standards. We will continue to act swiftly and forcefully when violations are putting consumers at risk, but we plan to focus our inspection teams on compliance and food safety outcomes as the best way to protect consumers and strengthen consumer confidence.
And, when we inspect, we want to be able to look holistically at a company’s approach to food safety, including its management commitment and food safety culture. When firms get it right at that level, they are much more likely to get it right in their operations, and FDA can focus more of its effort on firms that don’t demonstrate the same food safety commitment and culture.
Second, private verification and audit activities already play a central role in food safety systems, whether as part of a firm’s verification of preventive controls in its facility or to verify a supplier’s food safety practices. We value the role private audits can play when done properly. We thus believe we have common purpose with the food industry to ensure the rigor and objectivity of private audits, as well as to improve efficiency by reducing redundant or ineffective audits.
Closely related to the role of verification in our domestic food safety system is the role FSMA’s foreign supplier verification program (FSVP) requirement will play in assuring the safety of imports. The principle here is that those importing food into the U.S. market have the primary responsibility to verify its safety. We have proposed that a foreign verification audit by a “qualified person” typically would be part of the program in certain high-risk situations. But what makes a person “qualified” for this purpose? And how do we ensure the objectivity and rigor of these audits? We know many in the industry are working on this, but I believe it is – and I know it must be – our common purpose to ensure the rigor and objectivity of audits throughout the global food system.
Finally, I can offer two important examples of our collaboration on verification with other governments: Mexico and China.
In July of this year, we announced in Mexico City our new Produce Safety Partnership with the two agencies in the Mexican government that oversee produce safety: SENASICA and COFEPRIS. This is a priority for both countries because of the large volume of produce traded across our common border and the importance of produce safety from a public health and public confidence standpoint.
We have worked well with Mexico for many years and share a strong public health purpose with our counterparts there. But FSMA is bringing new produce safety standards and greatly heightened demand for verification that standards are being met. To meet this demand, Mexico and the United States are building a true operational partnership on produce safety. As it evolves over time, this will include even more sharing of information, personnel and best practices, laboratory and other technical harmonization, and mutual reliance on each other’s oversight work. It will also include a strong public-private partnership component.
Our important collaboration with China is at a different level of development, which is understandable given the greater physical distance and our different legal, regulatory, and technical starting points. In 2007, after the incident involving intentional melamine contamination of pet foods, FDA’s parent Department of Health and Human Services (HHS) established a regulatory cooperation agreement on food and feed with China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). This agreement was aimed at improving each country’s ability to judge whether food imported from the other meets the importing country’s requirements.
We are committed to the success of this agreement and, working with our Chinese counterparts, we have made real progress in the exchange of regulatory and technical information, laboratory improvement and harmonization, training on U.S. practices for Chinese inspectors and food companies, and mutual understanding. This effort is aimed at enabling FDA to consider AQSIQ’s oversight in making entry decisions for food shipments from China.
Key areas of focus at the time of the original agreement – low-acid canned foods, pet food and pet treats, and farm raised seafood – remain works in progress. The legal, regulatory and technical gaps between our systems are challenging, but we think they can be overcome with sustained effort. One thing we have learned is that we need more FDA presence in China to expedite the building of mutual understanding and confidence, which are the foundation for mutual reliance. Today, FDA has only four full-time China-based staff who focus on food safety issues, but we hope to increase that number to 12.
I’d like to close by saying that I can think of no better place to promote a common culture of prevention and verification than this conference in this country. As a global food safety community, we have the same purpose and face the same challenges. We all want food to be safe. We all want consumers to have confidence. And we all want trade to be unimpeded by food safety concerns.
I also think it’s clear how we meet these challenges. None of us – in government or industry – can do it by ourselves. It’s a food safety system. We all play crucial roles. To play them successfully, we have to work in concert to build a common culture, not only of prevention and verification, but of real collaboration and partnership.
Thanks again for having me here.