Food Safety Magazine

REGULATORY REPORT | February/March 2008

New Directions in Food Protection

By An interview with David W.K. Acheson, M.D.

New Directions in Food Protection

David W.K. Acheson, M.D., appointed in 2007 to the newly established position of Assistant FDA Commissioner for Food Protection by Commissioner of the Food and Drug Administration Andrew C. von Eschenbach, M.D., has had a busy year. In addition to his 30,000-ft. oversight duties related to the release of the national Food Protection and Import Safety plans, Acheson also served for a month-and-a-half as Acting Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) during the search to replace previous CFSAN Director Robert Brackett, Ph.D. In January, Director of FDA’s Center for Veterinary Medicine Stephen F. Sundlof, D.V.M., Ph.D., was named the new CFSAN Director. In January, von Eschenbach expanded Dr. Acheson's role by naming him Associate Commissioner of Foods, giving him an agency-wide leadership role for all food and feed issues, including health promotion and nutrition.

Acheson has also served as CFSAN’s Chief Medical Officer and Director of the Office of Food Defense, Communication and Emergency Response at CFSAN, where he played key roles in managing significant food safety issues and emergencies. He is a graduate of the University of London Medical School, with training in internal medicine and infectious diseases. He has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. Acheson is a fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America. He was a member of the National Advisory Committee for Microbiological Criteria for Foods from 1998 to 2007 and has served on World Health Organization working groups, as well as National Institutes of Health advisory committees. He has also held academic posts at the University of Maryland Medical School in Baltimore, MD, where he focused on research of foodborne pathogens, and at Tufts University in Boston, MA, where he researched basic molecular pathogenesis of foodborne pathogens.

Acheson spent some time recently with Food Safety Magazine to share his thoughts on the recently unveiled Food Protection Plan, Import Safety Plan and other upcoming agency initiatives in progress to further increase the safety of the U.S. food supply.

Food Safety Magazine: As Assistant FDA Commissioner for Food Protection, and recently, as the appointed Acting Director of CFSAN, your oversight responsibilities have been quite extended, Dr. Acheson. What are your professional objectives and goals for CFSAN in 2008?

Dr. David Acheson: In the position of Assistant FDA Commissioner for Foods, my role is to coordinate food and feed issues across the agency. One of my main responsibilities is to oversee the implementation of the Food Protection Plan, which includes a variety of areas broader than those that fall under CFSAN’s oversight. So my goals involving this high level coordination and leadership in the agency on food and feed haven’t changed.

Food Safety Magazine: With the release of FDA’s Food Protection Plan in November 2007, the U.S. now has a comprehensive blueprint to address both unintentional and deliberate contamination of the nation’s food supply. Would you give us a brief overview of the plan and describe its key elements?

Acheson: The plan was written at request of Department of Health and Human Services Secretary Mike Leavitt and Commissioner von Eschenbach, who, in May, laid out the need for a national blueprint. The resulting Food Protection Plan encompasses both food and feed, addresses both domestic and imported products, and deals with both food safety and food defense.

The plan has three core elements. The first is prevention, which is all about building in food safety upfront to prevent problems in the first place, whether involving domestic or foreign product. The second element is intervention, which involves targeted inspection and testing. The third element is response, which gets at improving speed of response and as part of response, improving communication with all stakeholders, including consumers.

These three core elements—prevention, intervention and response—are concepts that the agency has always implemented but there is a much greater emphasis on prevention in the Food Protection Plan. We’re trying to shift our focus from reacting to food safety problems when they occur to preventing them from occurring in the first place. The whole program is driven on the basis of risk—risk-based preventive strategies, risk based interventions and risk-based inspections are key to its success. We already have a risk-based food protection system established, so the Food Protection Plan has been developed to extend that system. This extension will require data input using our own data sources as well as acquiring data from others, and establishing research and scientific data needs to inform the risk management process. It will also require the use of modern technology; not just information technology but advanced detection and process control technologies.

Food Safety Magazine: You’ve indicated that the Food Protection Plan’s three core elements—prevention, intervention, and response—focus on identifying the level of risk over a product’s life cycle and targeting resources to achieve greatest risk reduction. How will this emphasis on risk management benefit supply chain stakeholders?

Acheson: Clearly, there are limited resources available to stakeholders in terms of implementing food safety and defense measures, whether we’re talking about a massive corporation that makes, distributes or prepares food, a small retail outlet, or a regulatory agency. So you have to use a risk-based approach to determine where you put those resources to achieve effective realization of food protection goals. To do that you have to acquire the data and the science to make the risk determination because essentially you are doing an exercise in risk ranking. Simply put, we want to know if Food A is riskier than Food B.

You want to evaluate risk along the whole product life cycle, which is another important part of the Food Protection Plan. Every food has a product life cycle, and whether it originates from a tree, a cow or a field, food may be processed or treated to some extent, packed or mixed with other foods, prepared or handled, cooked or refrigerated and transported, until it finally reaches the consumer. At various points in this supply chain, that food may be susceptible to contamination and we know that certain foods are more likely to get contaminated at certain points in that chain than others. So from a food safety standpoint, not only are we interested in whether Food A is a greater risk than Food B, but in looking a Food A we want to know where in that product’s life cycle is the food at the most risk for contamination so that we can determine where to best focus our prevention strategies. In other words, if you think the most risk for a particular item is on the farm first and foremost then you are not going to put your resources into preventing problems at the farm.

Now to do that you have to understand the science around how to prevent, how to mitigate, and how to do the risk ranking. That process is going to drive prevention strategies very heavily, and if you look at Food Protection Plan in more depth you’ll find that a fair part of the agency actions under prevention go along those lines of determining where the vulnerabilities are, what mitigations to put in place to prevent them, and the corporate role and responsibilities in those determinations. I see the agency’s role in this as providing leadership and a framework for approaching the “prevention first” mindset. We would endeavor to pass that framework on to industry, which can then put the prevention practices in place to safeguard the food supply. That, in turn, will drive advancements in science, technology, and interventions that will benefit all stakeholders in achieving food protection aims.

Food Safety Magazine: What other FDA food safety initiatives are in progress or on the horizon?

Acheson: There are a number of activities going on at the agency, and as we’ve been discussing, the Food Protection Plan is a significant one that falls under the sole oversight of FDA. The Import Safety Action Plan is another significant initiative which involves 12 different federal agencies and departments, including FDA. The latter has a big food component in it and, like the Food Protection Plan, is modeled on the prevention-intervention-response framework. That is not a coincidence, FDA worked very closely with the Import Safety Action Plan group as we were developing the Food Protection Plan so that they would be complementary.

Whether we are talking about the Food Protection Plan or the Import Safety Action Plan, I would caution that this is not a short-term sprint to get the job done. We’ve embarked on a marathon. We spent a lot of time thinking these initiatives through and at FDA, we are committed to making some key changes to focus on prevention and that’s a long-term fix. Of course, everyone is looking for the quick fix. Will we have it done by March? Well, no, we won’t, but our goal is to document progress and keep the communication channels open so that real-world benefits from its implementation will be readily seen as the plans evolve.

In terms of other food safety and defense initiatives, the Secretary has just signed a Memorandum of Agreement with China, one element of which includes food and feed. This is focused on the safety of specific products for a specific country. Another initiative is the FDA “Triple A,” which is the Administrative Action Plan that President Bush recently signed. This reauthorization act, which involves mainly drugs, also includes some foods issues, and we have responsibility for its implemention. These are a number of ongoing initiatives that we are addressing as part of the overall agency approach to food safety and food defense. Essentially, part of my job in the Assistant Commissioner role is to look at all the food- and feed-related parts of those various plans to make sure that we are moving forward in an appropriate direction and that we are not duplicating efforts within the agency as we implement these initiatives.

Food Safety Magazine: Can processors, foodservice, retailers and others in the food supply chain who have a stake in food safety contribute to making these initiatives a success?

Acheson: Industry already is making contributions and the agency is definitely looking to enhance the open communication channels we have in place. We put the Food Protection Plan out, which you describe as a blueprint, and now the plan has to be translated into operational activity so that it results in actual change and improvement in food protection. That has to involve a lot of input from the food industry. As we begin to plan the implementation of these initiatives, we envisage regularly meeting with industry and getting input. Primarily, we are very interested in modeling the prevention thinking around industry best practices. In other words, we are not looking to be highly prescriptive in directions that the industry is not already going in, but we have to capture those best practices and figure out what is or isn’t going to work and that requires a lot of dialogue with industry.

And again, we need to look at getting input throughout product life cycle. It is not just manufacturers and processors with whom this dialogue needs to occur; we also need to get input from growers, distributors, retailers and consumers. Each has a part to play in food protection and each plays a somewhat different role. Our intent is to make this a very open, transparent process. At end of the day, food safety is a partnership and it really is a team effort to make sure that each partner knows what the other is doing and why they are doing it so you end up with safe products.

Food Safety Magazine: In your opinion, what will be the most significant food safety issues in the next few years, and why? Are we equipped to meet these challenges, and how?

Acheson: The most significant challenge we face is focusing on how to prevent food safety problems in the first place. We are very good at reacting, but reacting is not really where you want to be in terms of effective food protection. We really want to build in food safety upfront. How do you do that? First, you’ve got to understand the science of how to prevent. If you are trying to prevent E. coli from getting on spinach, you have to understand how the E. coli get on there in the first place. Second, we’ve got to understand that we are in a global market and we’ve got to push the borders out and generate more dialogue with importers, foreign manufacturers and governments and people who want to import food into the U.S. The rise in imported goods into the U.S. market has steadily increased and I think we’ll see that trend continue, so we need to step up to the plate and figure out ways to address that. It's impossible to inspect all products; instead we want to focus our resources on inspecting and testing the products that are most likely to be problematic and spend less time on products that are unlikely to pose food safety hazards.

In addition to that 30,000-foot sketch, I would add another: the challenge of communication. There is a thirst for knowledge out there, and many consumers are blogging and using the Internet and there is a rapid dissemination of information now. This is great if you are plugged in but there is a sector of Americans who don’t logon to a computer everyday, who don’t blog or read a newspaper, and arguably they are some of the ones who we have to worry the most about protecting. Individuals in this group may be sick, immunocompromised or elderly. The group may even include small retail store operators who don’t have a computer and are not familiar with the modern information technology. I am speaking broadly, but we need to find ways to communicate food safety concepts to these individuals and find ways to get information out to those folks when there is a problem.

Categories: Regulatory: FDA