I’ve talked to people in the food industry, and I believe them when they say it is in their best interest to have a strong FDA. At first blush, you might think they want to be left alone to do their own thing. But the truth is they don’t. They want a strong FDA to provide the leadership, framework and standards for safe food. The big guys are pretty much already there; it’s the little guys that cause problems. That affects everyone.
FP: The ability of the FDA to monitor and sample the quality and safety of shipments has been greatly strained and budgets cut, partly because of the war. If you get additional funds, could you tell us what your priorities are and will be?
DA: The priorities focus on the three components of the Food Protection Plan. New money is not enough to do it all. It’s essentially a down payment on moving things forward. Under prevention, the money will be used to focus on what preventative controls work best for high-risk foods. Tomatoes and other produce are certainly high-risk, and we need prevention strategies in place.
Resources are already being used for a program we call FDA Beyond Our Borders. This relates to how we deal with imported foods. In the past, FDA has inspected food at the port of entry depending on what food and where it has come from. The new strategy is to work with foreign governments, manufacturers and importers to get a better understanding of what’s going on in those foreign manufacturing facilities. That involves focusing on specific countries.
We have plans to put an office in China before the end of 2009, hopefully, if the Chinese government concurs and it looks like they will. [China has since granted diplomatic approval for the FDA to open three inspections offices in China.] We will establish the physical presence of a small number of FDA employees, who will be there to better understand the processes within China and do some inspections, but really to integrate into how China operates. We’d like to do the same thing in India, and possibly in South America, the Middle East and Europe. Establishing a presence is a big shift for us, but it’s about building in prevention.
Under the intervention part of the plan, the new money is being used to hire inspectors to do more inspections and focus on developing new rapid detection technology. Both prevention and intervention are built on where the risk is greatest, so that’s where much of the money will go. Under the response part, where you go when bad things happen, there are a number of areas. What can we do to improve the speed with which we respond, improve traceability, and how can we work with industry to develop systems that will help us respond faster? That’s a smattering of where this new money will go.
FP: Should the FDA have more authority to demand foods and ingredients sourced from foreign countries/companies have the same food safety standards we demand from U.S. companies?
DA: The law stipulates that imported food has to meet our standards. They are required to maintain the same standards as we do in the U.S. if they want to import here. The key question is how do you verify that? Building new information technology platforms at the ports to allow us to better integrate multiple pieces of information about what is going on at foreign manufacturing plants and where the risks lie. That allows us to target the inspections at port of entry to the areas of greatest risk. There is no way that FDA could, or would want, to inspect or test every food item. It’s not a good use of resources, so you base it on risk. Part of the strategy with imports is to gather the information that will help inform that risk based process. Let’s say you have two shrimp manufacturers in a foreign country, how do you know if A or B has high standards? If you know one doesn’t follow requirements, you refuse entry. But if you have information that manufacturer B is state-of-the-art, and don’t know anything about A, the risk from A is greater than B, and you would test products coming in from A.
FP: In order to do more testing of foreign made ingredients, the FDA will need more staff. Do you anticipate the implementation of user fees? And is it feasible to bring experienced retirees back into the system on a part-time basis?
DA: First, to do this work, we do need more people both on the science and inspection side and part of the money is being used to hire more people. To do that, we need resources. User fees are an option, but there are pros and cons. FDA has not taken a position on them per se; our main interest is we need the resources. It’s up to Congress to decide where those resources come from. Some on the Hill have said we need user fees; some have said it needs to be done through appropriations. I look at it and say, just give us the resources.
In terms of retirees, there are two parts to that. People who retire usually retire because they want to retire. Assuming they want to keep working, we do have an infrastructure within FDA that uses these seasoned veterans from the agency. There’s a very well-organized Alumni Assn., and we use ex-FDAers to go out and provide technical assistant and talk about our regulations. We use them particularly in overseas travel, because they have more time and are content to do a week’s worth of work for FDA and take off the next week. We can’t do that; you do a week’s worth and you have to come home. Many of them love it.
FP: Consumer Packaged Good (CPG) companies are making more demands on what is already a very complicated supply chain that involves other countries, shipping, and tighter quality control efforts up and down the line. What more should they do, and how can they work together with FDA?
DA: Larger food companies already have pretty sophisticated traceability systems. The important thing is whether those systems are interoperable. If you have a package that has 10 different ingredients, does the system quickly trace back all 10 ingredients and where they come from if someone becomes sick? The second piece to this is how well do you know your suppliers? That is a key part in ensuring that your food is safe. You can have the greatest manufacturing controls in the world in your facility, but if supplies coming in are contaminated and you don’t know it, you have a problem. An important message is to really know your supplier, and simply not take it at face value when he says, “I’ve got a deal for you this week.”