Dear Editor,

As an advocate for comprehensive organizational change in FDA’s Food Program, I give Commissioner Califf and his team the credit they are due for the changes he announced this week. I still think that food inspectors should report to the Food Program leader, but the Commissioner’s plan moves strongly in the direction of a unified structure that can operate with much greater efficiency and unity of purpose than the current structure.   

As I read the proposal, it effectively dismantles the old version of the Office of Regulatory Affairs by taking out the state partnership office, the field food labs, and most of ORA’s headquarters staff working on food and moving them into a reshuffled version of the Center for Food Safety and Applied Nutrition under a single accountable leader. These are big changes, for which the commissioner deserves credit. Overall, it looks to me like a new organization with a chance for a fresh start, albeit with huge implementation challenges.  

My largest outstanding question is whether the new Deputy Commissioner will ultimately have the formal and practical authority within FDA to fully implement the reorganization plan, in both headquarters and the field, and to lead the necessary shift to a food safety culture of transparent engagement and collaboration, laser focused on risk-based prevention of foodborne illness.  The new structure makes this culture change possible but not inevitable.  FDA deserves the food community’s continued input and support to make it happen. 

Mike Taylor
Former FDA deputy commissioner for foods and current Board Member Emeritus at Stop Foodborne Illness

On April 6, the Food and Drug Administration fired an unmistakable warning shot at the leafy greens industry. I hope it will serve as a call to urgent action that gets to the root of the problem of the persistent presence of dangerous E. coli in the growing environment for leafy greens and other fresh produce.   

Carefully using the regulatory language in its produce safety rule (21 CFR 112.11) and citing the recurring nature of the E. coli hazard in the Salinas and Santa Maria growing area, FDA declared the recurring strain implicated in the 2020 outbreak to be a “reasonably foreseeable hazard,” which FDA attributed to the presence of cattle on land adjacent to growing fields. 

This finding seems obvious and shouldn’t be surprising. The surprise, however, is that FDA used regulatory language to express its finding and spelled out the implications: farms covered by the FSMA produce safety rule “are required to implement science and risk-based preventive measures” to minimize the risk of serious illness or death from the E. coli hazard.  

Make no mistake, however, FDA’s message is aimed not only at farms but at every entity involved in the commercial production, processing and sale of leafy greens coming from the California Central Coast Growing Region.  The message is that, without effective preventive measures, such leafy greens are in violation of federal food safety regulatory standards. 

I do not anticipate FDA taking judicial action to enforce its April 6 finding, absent egregious practices or clear negligence in a particular leafy green growing situation. I do see, however, a heightened sense of urgency at FDA and frustration that efforts to date have not solved the leafy greens safety problem. I share that frustration.  

Fifteen years ago, the disastrous spinach outbreak caused by E. coli O157:H7 was linked by the Centers for Disease Control and Prevention (CDC) to run-off from nearby grazing land. Since then, we’ve had outbreak after outbreak associated with E. coli in leafy greens and other fresh produce. And the outbreaks are just the tip of the public health iceberg.  The federal government estimates that 60 percent of all food-related E. coli O157:H7 illnesses are associated with fresh produce. The vast majority of these illnesses are not part of an identified outbreak.

The E. coli outbreaks and illnesses persist despite a lot of hard work by a lot of people in the leafy greens industry, researchers, the California Department of Food and Agriculture (CDFA), the FDA and its federal partners.  Stop Foodborne Illness, the organization of illness victims and their families whose board I co-chair, works with the California LGMA on the common cause of strengthening food safety culture in the leafy green industry. We also advise the Leafy Greens Safety Coalition, a group of leading retailers working to strengthen safety practices.  I have participated in the California Agricultural Neighbors Workgroup convened by CDFA Secretary Karen Ross. So, I know serious people are at work on the problem.

What then is the urgent call to action?  What do consumers expect of the leafy greens industry, especially those individuals and families who know first-hand the devastating human impact E. coli infections can have?  What does the public health demand?  

At one level, the answer to all three questions is the same. The leafy greens industry and all those across the leafy greens supply chain and in government should be doing urgently everything they reasonably can to minimize the now well-known risk posed by E. coli O157:H7.  According to FDA, the law requires no less. Certainly, this includes prevention measures within the leafy greens production system, such as strict implementation of rigorous water quality and irrigation standards, improved compost management, sanitation of harvesting equipment, and pre-harvest test-and-hold programs.  

But the prevention strategy must go deeper. Modern food safety best practices dictate that prevention should begin at the root of the problem.  As long as leafy greens are grown outdoors in the vicinity of cattle operations, I believe the food safety problem will persist until the shedding by cattle and the release of dangerous E. coli into the environment is minimized at its source. Effective vaccines are available. Changed feeding practices have promise. Perhaps containment measures can reduce risk.  

The experts need to determine what combination of measures works best, but it is clear that no responsible food manufacturer would today deem it acceptable to produce food in an environment in which dangerous bacteria are being released or are present on a sustained basis. The same principle should apply to leafy greens and other fresh produce grown outdoors.  

The important difference, of course, is that the leafy greens producer has no direct control over the source of the hazard.  And the cattle producer isn’t responsible for where leafy greens are grown. That is why FDA Deputy Commissioner Frank Yiannas calls for “industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community,” including cattle producers.  

I am glad FDA is sounding the alarm, but I know from experience that the kind of leadership and collaboration that is urgently needed is easier said than done in an industry and government structure that is notoriously fragmented and often works in silos. And the obstacles to solving the problem are not just technical. They include the need for creative solutions on such matters as who pays for interventions needed in cattle production to make leafy greens safe.   

But too much is at stake for all concerned to let such obstacles stand in the way.  Now is the time for leaders from all across the commercial value chain and government to act together, with greater urgency, to get to the root of the problem and prevent it. 

About the author: Mike Taylor is co-chair of the board of the non-profit consumer advocacy group Stop Foodborne Illness, which is a 25-year-old group supporting and representing foodborne illness victims and their families in efforts to keep other people from getting sick. Before that Taylor served as FDA’s Deputy Commissioner for Foods and Veterinary Medicine from 2010 to mid-2016. His first tour in government began as a staff attorney at FDA, where he worked on seafood safety and nutrition labels. Later Taylor worked for USDA’s Food Safety and Inspection Service, where he became acting under secretary for food safety. Taylor was the government official who, after the deadly 1992-93 Jack in the Box hamburger outbreak, ruled that the pathogen E. coli O157:H7 is an adulterant in meat. Taylor also practiced law in the private sector.

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Twenty-five years ago, when I was administrator of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), I helped put in place a new food safety regulatory program to prevent foodborne illness from meat and poultry.  We created this program in response to the tragically historic 1992-93 illness outbreak caused by ground beef contaminated with a particularly dangerous type of E. coli called E. coli O157:H7.  

Those rules were effective for ground beef because we had a scientific basis for declaring that particular strain of E. coli an adulterant. This meant that USDA could use its inspection and enforcement tools to keep the pathogen out of beef products, and industry had a powerful regulatory incentive to develop and implement innovative preventive measures. It was a major advance in food safety at the time. But, while the FSIS program has improved beef safety, its provisions related to poultry have not succeeded in significantly reducing the many illnesses and deaths caused by two other dangerous kinds of bacteria — Salmonella and Campylobacter — commonly present in chicken and turkey.  

This issue has vital importance for public health and for consumer trust in the safety of poultry.  The two bacteria of concern account for over 70 percent of the illnesses transmitted commonly by food and tracked by the Centers for Disease Control and Prevention through its FoodNet surveillance system, sickening an estimated 1.9 million Americans each year. Some 21 percent of the Salmonella cases and more than 66 percent of the Campylobacter cases are attributed specifically to poultry.  

The explanation for this failure is painfully apparent: What we considered groundbreaking 25 years ago is now woefully obsolete for these pathogens. The FSIS poultry safety rules have fallen far behind the evolving science of foodborne illness and do not incorporate what both government and industry now know about preventing foodborne illnesses from these two bacteria. 

Based on what we knew in the early 1990’s, we set so-called performance standards for Salmonella as a generic and broad category of related organisms common in poultry. FSIS now uses these “standards” as a benchmark in overseeing the effectiveness of steps individual slaughterhouses are taking to prevent excessive contamination of poultry with generic Salmonella. 

The standards do not apply, however, to the raw products themselves. 

Moreover, they are not legally enforceable. As a result, FSIS routinely inspects and passes Salmonella-contaminated raw poultry products, regardless of its own performance standards showing the slaughterhouse is performing poorly.

Further, scientists in government, industry and academia now know that most of the illnesses and deaths due to Salmonella are caused by a handful of specific types of the bacteria, just like specific types of E. coli are much more damaging and deadly than generic E. coli. It is past time for FSIS to take this science into account and set enforceable finished product standards for the specific types of Salmonella that make people sick, as it first did 25 years ago for E. coli.  FSIS should set enforceable science-based product standards for Campylobacter as well.

We also know now that dangerous types of Salmonella and Campylobacter typically originate in chickens on the farm and spread in breeding flocks and in on-farm growing houses before the chickens even reach the slaughterhouse. And, we know these bad bacteria can be controlled at that earlier stage of the production process. FSIS and its independent scientific advisors say so, and some leading poultry producers are already implementing improved sanitary practices and using vaccines on the farm to reduce the Salmonella contamination of birds entering slaughterhouses. So, we know better prevention is possible.

Yet, the FSIS regulatory system includes no requirements that poultry companies implement on-farm control measures or even be aware of the microbial quality of chickens entering their facilities. This is another way that the FSIS program lags far behind both the science of food safety and modern best practices for preventing food safety problems.  

I had the privilege of overseeing implementation of the Food Safety Modernization Act when I served as FDA’s Deputy Commissioner for Foods and Veterinary Medicine from 2010-2016. This law and FDA’s implementing rules, which apply to all food except meat, poultry and certain egg products regulated by FSIS, requires food manufacturers and processors to carefully monitor the safety of their raw materials and verify that their suppliers are taking appropriate measures to minimize hazards, such as bacterial contamination. This is a core component of modern best practices for food safety.  

That same principle and similar requirements should apply to meat and poultry, but they don’t under the FSIS program. This is unacceptable. 

These regulatory failures and resulting illnesses are why Stop Foodborne Illness, the consumer organization whose board I co-chair, is joining with the Center for Science in the Public Interest, Consumer Reports, and the Consumer Federation of America to seek overdue modernization of the FSIS poultry safety program. We are petitioning USDA and FSIS to promptly begin a stakeholder engagement and rulemaking process to set enforceable finished product standards and require poultry companies to implement and verify effective on-farm prevention programs.  

We recognize the technical issues are complex and the process will take time. But the food safety principles and consumer protection purposes are clear.  It’s time — it’s past time — for USDA to bring people together and do the work needed to make the FSIS regulatory system and mark of inspection for poultry mean something for public health.  

About the author: Mike Taylor is co-chair of the board of the non-profit consumer advocacy group Stop Foodborne Illness, which is a 25-year-old group supporting and representing foodborne illness victims and their families in efforts to keep other people from getting sick. Before that Taylor served as FDA’s Deputy Commissioner for Foods and Veterinary Medicine from 2010 to mid-2016. His first tour in government began as a staff attorney at FDA, where he worked on seafood safety and nutrition labels. Later Taylor worked for USDA’s Food Safety and Inspection Service, where he became acting under secretary for food safety. Taylor was the government official who, after the deadly 1992-93 Jack in the Box hamburger outbreak, ruled that the pathogen E. coli O157:H7 is an adulterant in meat. Taylor also practiced law in the private sector.

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But, I am concerned that leaders in Washington have lost their focus on food safety.  The best evidence of this is the lack of follow through to fully fund implementation of FSMA. The president’s 2019 budget request for the Food and Drug Administration, now pending in Congress, is essentially flat for food safety, which means a decrease in actual purchasing power due to rising costs for delivering services. 

In contrast, for FDA’s medical product programs, the 2019 budget requests an increase of more than $400 million. This imbalance in investment priorities occurs despite the fact that Congress has appropriated only about half of what the Congressional Budget Office estimated would be needed to successfully implement FSMA.   

This funding shortfall will have consequences in at least three strategically crucial areas.  

Imports — Congress mandated a new import safety system that includes new accountability for importers and many more FDA inspections of foreign facilities. FDA has put key pieces of the new system in place but is far short of the resources needed to fully implement the FSMA import mandate.  

Federal-state partnerships — FSMA envisions a true operational partnership between FDA and the States on produce safety. FDA has prioritized this, but success requires continued investment to build the capacity of states to provide the education and technical support to farmers, coupled with the high-quality inspection and enforcement, needed to prevent illness outbreaks in this crucial sector of our food system. 

FDA’s public health transformation — FDA is on a path to transform its oversight of food producers and processors and its approach to outbreak response to focus more intensely on the public health goal of preventing foodborne illness by using new technological and regulatory tools. But the needed modernization and melding of how FDA’s headquarters experts and field forces work together to deploy FSMA’s new tools for prevention and response is unfinished business that requires sustained focus and investment.  

It was my privilege to lead FDA’s food program from 2010 to 2016. This leaves me with the greatest respect for the people working there now, at all levels. Their commitment to public health is beyond question. I also understand the complexity of the daily and strategic challenges they face.  

In my current role with Stop Foodborne Illness — the consumer organization that for 25 years has represented and supported individuals directly affected by foodborne illness — I have had many conversations with people who were key to the consumer-industry coalition that supported the enactment of FSMA in 2011. This broad community’s passion and commitment to food safety remains as strong as ever and as necessary as ever. 

We now need our leaders in Washington to do their part by following through on funding and on the public health transformation FSMA envisions.

About the author: Mike Taylor is co-chair of the board of the non-profit consumer advocacy group Stop Foodborne Illness. Before that served as FDA’s Deputy Commissioner for Foods and Veterinary Medicine from 2010 to mid-2016. His first tour in government began as a staff attorney at FDA, where he worked on seafood safety and nutrition labels. Later Taylor worked for USDA’s Food Safety and Inspection Service, where he became acting under secretary for food safety. Taylor was the government official who, after the deadly 1992-93 Jack in the Box hamburger outbreak, ruled that the pathogen E. coli O157:H7 is an adulterant in meat. Taylor also practiced law in the private sector.

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• Shifting the focus of FDA’s food safety oversight from reaction and after-the-fact enforcement to risk-based prevention of food safety problems;
• Creating a national, integrated food safety system that leverages state, local and tribal food safety efforts, and ensures nationwide consistency in oversight, and,
• Implementing an entirely new import oversight program that includes importers taking greater care of the foods they bring into the U.S., greater FDA presence overseas, and facilitation of trade in safe food.

Thus, the modern food safety system envisioned by Congress requires a true transformation in how FDA approaches its day-to-day food safety work and how it works with its government partners and the food industry to achieve high rates of compliance with the new FSMA rules. This includes a new compliance strategy focused on public health outcomes and based on clear guidance, education, and technical assistance to help industry understand and voluntarily comply with the new requirements, minimizing the need for FDA to take enforcement measures. Investment in this transformation cannot wait until the produce and preventive controls rules become final in late 2015. We are actively planning the transformation now, but, to implement it on a timely basis, we must make serious investments in 2015 and 2016 in FDA training and expertise, state training and capacity building, technical assistance infrastructure, and the new import oversight system. Training in the details of the final rules will come after the rules are finalized in late 2015 and before implementation in food facilities begins in late 2016, but this is just one part of the larger investment needed for FSMA to be successfully implemented and avoid unwanted delays and disruptions in implementation.