About FDA

Retail Food Safety: Complementing the Preventive Controls Approach Embodied in the Food Safety Modernization Act

Remarks at the Conference for Food Protection
Indianapolis, IN

April 14, 2012

As prepared for delivery by
Michael R. Taylor
Deputy Commissioner for Foods
U.S. Food and Drug Administration


It’s a pleasure and an honor to join you today as you begin the 2012 biennial meeting of the Conference for Food Protection. I see from the agenda that you get down to business quickly, having already been through a day-long workshop on Norovirus. This is true dedication on a Saturday.   In fact, I see the entire agenda for this meeting is packed with important issues such as the safe transportation of food, standards for those who certify Food Protection Managers, the control of food allergens at retail, and hand hygiene and other food employee practices, just to name a few.

I have great respect for the important public health work performed by our colleagues in state and local government. Before I returned to the Food and Drug Administration in 2009, I was a research professor at the George Washington University School of Public Health and had the opportunity to work closely on food safety with associations representing state and local health officials and food safety regulators. That work deepened my understanding of what you do and my respect for the role of  state and local health and agricultural departments as the foundation of the nation’s food safety system.

I also have great respect for the progress that can be made through partnership and consensus-building across public-private lines—an approach the Conference for Food Protection has embodied for more than 30 years. In bringing together academia, industry, consumers and regulatory agencies at the local, state and federal levels, you provide an excellent model for how positive and sustainable change can be made. 

So I am pleased to be here today to compliment you on the work you do and to update you on our progress at FDA. But I am also here today to talk about the challenges that still lie ahead and the work we must do together to achieve our food safety goals.

We are making food safety progress on a number of fronts, but the burden of foodborne illness remains high. Based on data from the Centers for Disease Control and Prevention, we know that about 48 million people—or 1 in 6—get sick each year from foodborne illness. Of these,128,000 are hospitalized and 3,000 die.

In addition to addressing this public health problem, our work is crucial to maintaining consumer confidence in the safety of the food supply, and I know this audience recognizes just how important that is at the retail level.

Addressing the Farm-to-Table Chain

I want to outline today FDA’s priorities and activities in the arena of retail food safety, but I think it’s important to see the role of retail food safety in the context of our overall farm-to-table food safety strategy and food safety system.

As this audience knows very well, achieving food safety requires taking appropriate steps to prevent problems at every step along the farm-to-table chain, and by every participant in the system: agricultural producers, food processors, transporters, retailers, and consumers. Food safety solutions have to be food system solutions.

For the first time, with enactment of the FDA Food Safety Modernization Act (FSMA), this fundamental idea is now codified in federal law, along with new authorities and mandates to implement the idea by building a new, prevention-oriented and integrated food safety system. Building the modern, integrated system envisioned by Congress demands that we strengthen existing collaborations and partnerships and build new ones among public agencies and with the private sector. The Conference for Food Protection is a prime example of collaboration on which we must build.

Let me give you a whirlwind tour of the farm-to-table spectrum.

At the production level, FSMA charges FDA with setting standards for fresh produce growing and handling practices that are “reasonably necessary” to prevent the introduction of “reasonably foreseeable hazards.” The prevention mandate is clear, but produce safety is one of the most technically challenging food safety tasks FDA has ever faced, due to the diversity of crops, geographical areas, growing and packing practices, scale of operations, and markets. The standards we set must make a practical difference for food safety, which means having many important attributes. They include being risk-based and scale appropriate and being flexible enough to take into account both the diversity of the produce sector and emerging science.

In food and animal feed processing facilities, FSMA mandates that all processing facilities implement preventive controls that are appropriate for their operations. FDA has required HACCP (Hazard Analysis and Critical Control Points) for seafood and juice processors, as has USDA for meat and poultry, but FSMA makes HACCP-type preventive controls the norm in all food processing facilities.

Transportation is an area that hasn’t received as much attention as others, but it is another important part of the farm-to-table chain. Two years ago, we issued an advance notice of proposed rulemaking to explore the possibility of establishing prevention-oriented requirements for safe food transport and ask such questions such as: What proportion of vehicles transport both food and nonfood products? Why types of records are currently kept by transporters and are there additional records that would be useful? FSMA mandates that we set safe food transport standards, and FDA is now working on a proposed rule on which it will seek further public comment.

This audience certainly knows the crucial food safety role played by the retail sector – encompassing everything from restaurants and grocery stores to foodservice operations in nursing homes and hospitals. And you know the challenge this presents due to the sheer scale of the sector, its diversity and complexity, and its direct link with consumers. Retailers have critical food safety responsibilities and challenges within their own facilities, but many are also making great contributions to food safety by virtue of how they manage their supply chains. Indeed, major retailers have played an important role in driving adoption of preventive controls by their suppliers, independent of any government mandate. 

As I will illustrate in a moment, FDA is committed to working closely with our state and local government partners and the retail industry to continue progress on retail food safety.  This is fully in keeping with FSMA’s mandate to create an integrated national food safety system.  Through this Conference and other efforts, we have together created a solid framework for food safety and have implemented many needed improvements in the food safety practices observed in retail establishments.  But I think we can all agree there is more to be done.

Consumers are the final crucial link in the farm-to-table spectrum and also share the responsibility for safe food as the final preparers of food and the last step before a potential case of foodborne illness. Of course, we don’t regulate consumers. But we have to consider their role and work with them as part of our prevention strategy. FDA has a long history of work in this area, but we have made a new commitment, working through the Partnership for Food Safety Education, to take consumer education to the next level. This includes: learning how to motivate consumers to change food safety behaviors, using new communications channels to reach consumers, and being able to measure progress.

Like retailers, consumers have a right to expect that everyone in the commercial chain has done everything they reasonably can to minimize food safety risks before the food reaches them. With full and effective implementation of FSMA, this is more likely to be the case. But food handlers—whether in the home or in food safety establishments--still will have to observe safe food handling practices. This reality just reflects the basic insight that underlies our farm-to-table food safety strategy, which is that a breakdown at any point in the system can result in a foodborne illness that could have been prevented if appropriate practices had been observed.

Food Safety Modernization Act

Before highlighting key elements of FDA’s Retail Food Safety Initiative, let me update you on our progress in implementing FSMA’s farm-to-table prevention mandate.   At FDA, we see 2012 as a pivotal year for FSMA implementation. FSMA became law on January 4, 2011, and we spent much of 2011 conducting extensive outreach and dialogue with our consumer and industry stakeholders and, on that basis, developing several major proposed rules that comprise the basic framework for FSMA implementation.   These include proposals addressing:

  • Preventive controls in human food facilities;
  • Preventive controls in pet food and animal feed facilities;
  • Produce safety standards;
  • The duty of importers to verify that their imports meet U.S. safety standards through a “foreign supplier verification program;” and
  • Accredited third-party certification of food safety compliance.

These proposed regulations are directed at farms and facilities and importers, not at the foodservice and retail food sectors. But, as outlined earlier, they will certainly affect your work and your businesses in terms of the safety of food that is available to you and your customers.

The first four rules I mentioned are in the late stages of administration review, and we hope to publish them soon. The accredited third-party certification proposal should go into review later this spring. For all of the proposals, we will hold public meetings and provide other opportunities for input and dialogue, including written comments. For further information on the FSMA implementation process, you can go to FDA’s FSMA web page at http://www.fda.gov/fsma.

Together, these five rules comprise the foundation for a comprehensive, science-based food safety system that addresses both domestic and imported food.  It is crucial we get the rules right. Then it will be crucial to achieve high rates of compliance with the rules. This will be done in part through inspection and compliance activities under new mandates and using new tools provided by FSMA.

FDA realizes, however, that compliance must be built on a foundation of guidance, technical assistance, education and training that will ensure government and industry have a common understanding of what the rules require and the capacity to implement them effectively and efficiently. We are already working collaboratively with the food industry and our state and local partners on this critical implementing work through the Produce Safety Alliance, the Preventive Controls Alliance, and other channels.

FDA Retail Food Safety Initiative

Let me turn now to the retail food safety work that is of most immediate concern to the Conference for Food Protection.

In October 2010, FDA announced a Retail Food Safety Initiative as part of our prevention-based, farm-to-table food safety strategy. The actions in the initiative are supported by FDA’s 10-year study of more than 800 retail food establishments to assess the retail and food service industry’s control of five key foodborne illness risk factors.

The Initiative has four major action goals:

  • First, make the presence of certified food protection managers common practice;
  • Second, strengthen active managerial control at the retail level and ensure better compliance with food safety standards;
  • Third, encourage widespread, uniform and complete adoption of the FDA Food Code; and
  • Fourth, create an enhanced local regulatory environment for retail food operations.

Let me address the progress we have made on these four goals.

Presence of Certified Food Protection Manager

For the first action item, making the presence of certified food protection managers common practice, we are happy to see that the Supplement to the 2009 Food Code requires each food establishment to have at least one certified food protection manager. This is a very important development, and it is supported by data both FDA and CDC have collected.

Data from the last two collection periods in FDA’s Retail Risk Factor Study point to a correlation between the presence of a certified food protection manager and better food safety practices and behaviors. We would like to see this requirement for a certified food protection manager during all hours of operation, wherever feasible, but we are pleased with the compromise reached at the last CFP meeting. We look forward to having the presence of a certified food protection manager become the widely implemented “standard of care” in retail establishments.

The challenge, of course, is implementation of this goal, and we are encouraged by industry’s willingness to work with us. Just recently, for example, the Food Marketing Institute’s (FMI) Board of Directors issued a policy statement in support of having Certified Food Protection Managers on board in retail establishments and effective training for all associates.

We have recently hosted roundtable discussions with various industry groups, such as the National Restaurant Association (NRA), the National Council of Chain Restaurants (NCCR), and FMI and are in the process of establishing partnerships with the restaurant industry, retail stores and institutional food service operations.  These partnerships will help us to develop uniform messages, standardize training programs, develop effective certification programs, and share best practices. They also will provide an opportunity to identify and overcome obstacles that both large and small businesses face in fully implementing effective preventive controls at retail.

Strengthen Active Managerial Control and Ensure Better Compliance

On the second action item, active managerial controls, we know that food safety is enhanced when managers assess their food safety systems, implement appropriate procedures and training, and actively monitor compliance with those systems to reduce risk in retail operations.

In order to broaden the adoption of these practices throughout the industry, FDA is working with its partners to assess the effectiveness of various managerial control strategies, identifying and sharing what works, and verifying their implementation in the food establishments.

For example, from our Risk Factor Study, we know that the industry and regulatory community need to focus their efforts on improving personal hygiene, especially employee hand washing; proper temperature control for foods; and preventing cross contamination in the foodservice and retail environment. We need to determine the best ways to ensure food establishments develop procedures, and that they effectively train their associates and then verify that those procedures are being implemented. This is where the emphasis needs to be placed during regulatory inspections as well.

We know that many establishments have their own programs to promote active managerial control of food safety hazards at retail.  We also recognize that regulatory agencies around the country are enhancing their traditional food inspections to include the assessment of the management systems that are in place in the food establishment. FDA’s Retail HACCP Manuals for Operators and Regulators have helped move us in that direction, but they need to be revisited to reflect what we have learned over the past several years about the challenges of managing food safety, day in and day out.   Of course, we will also continue to work with the Conference for Food Protection to consider modifications to the FDA Food Code to promote effective management practices and training of food employees.

Widespread, Uniform and Complete Adoption of the Food Code

Regarding adoption of the Food Code at the State and local level, I believe we have our work cut out for us. While every State has modeled its retail food safety regulations after the FDA Food Code, only a handful of agencies have adopted the 2009 Food Code into regulation.  FDA will continue its work with the retail industry and state, local and tribal authorities to ensure that prevention-oriented, science-based food safety regulations are enforced at the retail level. Promoting complete and timely adoption of the latest Food Code provisions, such as the one addressing Certified Food Protection Managers, is an important component of this strategy. Of course, the commitment of all who participate in the Conference for Food Protection is critical to ensuring that the Food Code remains a document that reflects the latest science, drives industry best-practices, and can be effectively enforced.

Enhanced Local Regulatory Environment

Our state and local partners perform the frontline inspection and compliance work that is an important element of ensuring retail food safety. Thus, their capacity to do this work is essential to success, and we know that many of the initiatives outline here require additional funding.  Recognizing this, we have made it a priority to contribute as we can to enhancing the local regulatory environment and capacity for retail operations.

Our part of this is state and local implementation of the FDA Voluntary National Retail Food Regulatory Program Standards. FDA’s financial support for jurisdictions enrolled in this key program was just $250,000 in FY 2009 and 2010. In Fiscal Year 2011, we increased that to over $1 million.   We plan to significantly increase that investment in FY 2012 and will soon announce the availability of cooperative agreements to provide resources to help state, territorial, local and tribal agencies to implement inspection and educational programs that drive better industry performance. Hopefully, our budget will allow us to continue to provide support for State and local retail programs in this manner. We know it makes a difference because, in Fiscal Year 2011, we saw 87 jurisdictions newly enroll in the program standards. The current number of enrolled jurisdictions now stands at 501.

In addition to this good news on funding, we have established a multi-year cooperative agreement with the National Association of County and City Health Officials (NACCHO) to promote the use and sharing of best practices by food safety and inspection programs at the local level. Under the cooperative agreement, NACCHO and FDA have initiated a mentorship program for local health departments to help newer enrollees in the Retail Food Regulatory Program Standards benefit from the experience of those who have already achieved key milestones in implementing the standards.  Under the Cooperative Agreement, NACCHO and FDA are also exploring ways to assist local health departments that are pursuing Public Health Program Accreditation at the same time they are striving to meet the Voluntary Retail Food Regulatory Program Standards.


So I really do see 2012 as being a pivotal year for food safety—not just because FDA is implementing the new federal food safety law but because of all the important work being carried out at retail and in foodservice operations to take preventive controls even further.   

I recognize the challenges we face, with uncertain budgets and an increasing workload. I also recognize the particular challenges retail and food service establishments face, including training a workforce with rapid turnover.

But I also see new opportunities to make significant improvements by working together through partnerships. I see that happening all along the farm-to-table chain, and I see the great potential for real progress that these partnerships represent. I look forward to partnering with all of you to improve food safety.

Thank you.

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