Q: For many people, something early on in life helps shape our goals and set our path for who we’d like to become. Was there something or someone who influenced your path to food safety?
A: Yes, there is, definitely. My father had a tremendous impact on me by encouraging me to build a career around something I care about at a real personal level. His idea assured that, if I did, the practical aspects of life would fall into place. Since high school, I’ve been interested in how government can work to help people, and I’ve been guided by a strong desire to work in public service and public policy. I’ve done other things, too, but public service has been the overarching theme of my career.

Q: Public service is a big arena. How did you end up in the business of ensuring the safety of the country’s food supply?
A: When I was coming out of law school in 1976, I knew I wanted to work for government, but I didn’t have my eye on public health yet.

Fortunately, I got connected with Richard Merrill, a professor at the University Of Virginia School Of Law who was serving as chief counsel for the FDA. I interviewed at FDA for a staff lawyer job, and though I didn’t have any background in food and drug law, I got the job. And it was love at first sight. The issues were so real in terms of affecting people’s lives in a place where law, policy, and science all come together to get problems solved.

I was assigned early on to the Bureau of Foods, now the Center for Food Safety and Applied Nutrition (CFSAN), as a legal advisor. This was a time when chemicals in foods were a big concern— such as PCB’s, dioxins, aflatoxin and food and color food additives, from saccharin to sodium nitrite. I cut my teeth on this work.

But it was in the early 1990’s, when I was serving at FDA as deputy commissioner for policy and then went to work at USDA in 1994, that my focus on foodborne illness as a public health problem that needed to be solved really crystallized.

Q: In 1994, soon after becoming the administrator of the Food Safety and Inspection Service at USDA, you declared ground beef contaminated with E. coli O157:H7 as adulterated. What do you consider most significant about that change and its impact on America?
A: First, let me start by setting a little context.

In late 1992 and early 1993, the tragic Jack-in-the Box outbreak struck the country. More than 600 people were sickened and four children lost their lives after eating undercooked ground beef contaminated with E. coli O157:H7. USDA’s policy at that time was that pathogenic bacteria are known to be present in animals and raw meat, and that restaurants and consumers were responsible for cooking these products to safe temperatures. So, according to USDA at the time, pathogenic bacteria didn’t make raw meat adulterated. In short, there wasn’t legal accountability within the FSIS meat inspection program for preventing or minimizing the presence of dangerous bacteria.

So when I arrived at USDA in August 1994, my most important mission was to set up a system of accountability for reducing pathogens in meat. The first pathogen to be addressed, of course, was E. coli O157:H7. This strain of E. coli is unique because it’s very dangerous even at very low levels and found in ground meat used for hamburgers, which are customarily cooked by many consumers in a way that does not produce a safe temperature throughout.

We then asked this critical question: Should it be lawful to produce and sell ground beef that is contaminated with E. coli O157:H7? Should it be able to enter the marketplace? Our answer was “no.”

USDA then declared E. coli O157:H7 an adulterant in raw ground beef, making ground beef contaminated with the pathogen illegal to sell to consumers. It was during this early period at FSIS that I first encountered STOP. I was deeply touched personally and strongly motivated by their advocates’ experiences losing family members to foodborne illness or suffering terribly themselves from the often permanent damage caused by E. coli O157:H7.

This decision to declare E. coli O157:H7 an adulterant established the principle of accountability for reducing pathogens in meat.

Q: Where did that decision lead and what impact did it have?
A: Our next step was applying the principle of accountability for preventing or minimizing pathogens more broadly to meat and poultry—the full range of products regulated by FSIS—so we went through an intensive rulemaking process to mandate Hazard Analysis and Critical Control Points (HACCP) for all meat and poultry processing plants. This set up a system of accountability for implementing preventive measures to reduce pathogen contamination in these plants and included standards and testing requirements for reducing Salmonella as a surrogate for the category of pathogens that enter food as a result of fecal contamination.

The best part, which makes every single ounce of work involved worth it, is this: Lives are being saved and health protected because of these new protocols. Since FSIS declared E. coli O157:H7 an adulterant and implemented HACCP, the Centers for Disease Control and Prevention has documented significant reductions in O157 cases.

This work was important on many levels, including as it relates to laying a foundation for the Food Safety Modernization Act (FSMA).

Q: Tell us about a typical day in your work for the FDA?
A: Lots of meetings is the first thing that comes to mind!

My job at FDA is to set strategic direction and help make decisions and that means a calendar packed with meetings. I talk with A LOT of people on any given day—with staff members and people throughout the FDA, CFSAN, the Center for Veterinary Medicine (CVM), and the Office of the Commissioner (OC). I also have meetings with people at the U.S. Department of Health and Human Services (HHS) and with our colleagues at the U.S. Department of Agriculture and elsewhere in the federal government. And I have many external meetings where I spend time talking to people from industry, consumer groups, state regulatory partners and many other stakeholder groups. My spending so much time talking with people is reflective of the fact that making food safe, on-the-ground, depends on the collective effort of the many people who are producing, preparing, making food across the food system, as well as the people in FDA and other agencies that provide regulatory oversight. Everyone has to be engaged.

Q: How do you keep it all straight?
A: I have a fabulous staff!

Q: What do you love about your work?
A: The chance to have a positive impact on people, to be working on problems that really matter to people. I also enjoy the challenge of solving complicated policy problems—my background is largely in food safety and public health policy.

But it comes back to working with people and helping people align behind a strategic direction. What are we trying to achieve? And how will we do it? Achieving and maintaining that alignment is the why reason I meet with so many people inside and outside of government.

I hope I do more listening than talking. The important task before me now is bringing people together. This is crucial to success.

Q: When it comes to FSMA, STOP believes this holds great promise for protecting Americans from the dangers of foodborne illness. What’s the greatest challenge you’re facing with FSMA implementation?
A: The short answer is resources. Getting the resources necessary to properly implement the law is our largest, most critical challenge.

But, let me go beyond that and share a little more with you because implementing FSMA is quite complex.

It’s first about getting the rules right. Setting prevention-oriented food safety standards that are effective and workable for our very diverse food industry is challenging, to say the least, but we’re confident we’ll get there.

The larger, longer term challenge is properly implementing the new rules once we finally issue the major ones in late 2015, and this is where our resource needs are most significant. We’re having good dialogue with the community on this, and there’s a lot of common understanding around how to go about implementing the new FSMA rules. But, it will take a fundamental reorientation of FDA’s oversight program, including retraining of the FDA and state inspectors and compliance staff to implement FSMA’s risk-based focus on public health outcomes and modern preventive controls. It will also require significant training and technical support for industry and investment in the new import oversight system mandated by FSMA. All of this requires resources well beyond what we have now.

Q: FSMA’s focus on prevention is paramount. How would you encourage the general public to think about food safety in terms of prevention?
A: It’s more a matter, I think, of the public’s expectations—I need to listen to them, not tell them. I’ve had many conversations over many years – most people understand that we don’t have a risk-free food supply but they expect that people in government and industry who are responsible for food safety are doing everything they can to make it as safe as possible. Most consumers understand they have a role as well—preparing and handling food safely, but it cannot be solely their responsibility.

Q: STOP supporters are dedicated advocates who volunteer their time and energy to advance the food safety conversation in America. What is the most important action you encourage they take to make an impact?
A: Speak up and use their powerful voice.

When I first began my work at the USDA and was leading change there, one of the first people I met was Nancy Donley. Her story is unforgettable. Nancy’s voice, along with the voices of so many other STOP advocates I’ve met, has made ALL the difference in bringing about the positive change we see in food safety today. People weren’t hearing stories like these until STOP started telling them. And they make a big impact on the work we do at FDA. It’s the central motivation and justification for what we do.

Q: The amount of materials and information available on the FDA website is huge. Is there anything, specifically, that you’d recommend for STOP supporters?
A: We’ve got some very helpful resources for consumers on many aspects of food safety. We encourage public comment on all open proposals related to FSMA. Keep an eye out on our website for four supplemental FSMA proposals coming out soon. And people can sign up for our FSMA listserv to get frequent updates.

Q: On a personal level, why is STOP important to you?
A: Without a doubt, my experience working with STOP advocates when I first started at the USDA is the source of my passion for strengthening our food safety system. I’ll never forget hearing the moving stories of parents who’d suffered tragic losses due to foodborne illness, but weren’t going to take it lying down. Working with STOP touches every part of the work that I do. It sustains my motivation to keep doing what I’m doing.

Q: Any other thoughts you want to share?
A: Together, let’s stay the course.

We need to be in it for the long haul. Food safety is an ongoing journey of continuous improvements, with no finish line. I’m deeply grateful for STOP’s 20-year commitment to food safety, and I’m excited to see what STOP advocates will accomplish during their next 20 years.