As for how food companies can work with the FDA, we can’t work well with 300 different systems. We need a consensus on interoperable systems for supply chain management and traceability that’s actually going to work across the board. A final thing, and where there is some discussion, is how do we leverage off each other’s information without compromising each other’s information? Industry has a huge amount of data and information they are reluctant to share with us. They don’t want us to take regulatory action based on information they have. Similarly we have confidential information we can’t share. We all have a ton of data, but how do you analyze and utilize the information we already have, and how can we work together to leverage off each other? That’s hard, but we have to build trust. Building trust is ultimately what’s going to make this work with industry.
FP: The European Food Safety Authority (EFSA) has an outreach program with its trading partners. The FDA has been somewhat isolated in the past, and is that changing under your watch? Is there a possibility of integrated labels?
DA: At a higher level, there is a lot of conversation going on within the FDA and between FDA and other parts of the world such as the EU on how we can look at unifying approaches and leveraging off what each other’s got. The focus has not been on labeling specifically. One of the key parts to that is, how can we share the information we have and leverage off it? An example would be that if the EU had been to a foreign manufacturing facility and found problems and FDA needs to inspect the same plant, it would make a lot of sense to build relationships so that we don’t have to go in right behind them – we could share the information and leverage off each other’s resources. That might ultimately translate into uniform labeling. I don’t know; we are operating at a higher level here. It makes no sense for every developed nation to duplicate what every other developed nation is doing. Again, that means developing trust and transparency between regulatory agencies. That’s an active part of planning right now in the FDA – how can we do that? I’ve met often with the Europeans, likewise with the Canadians, Australians, New Zealanders and others.
FP: The FDA allows ingredient suppliers to do private research to self-affirm their ingredients GRAS (generally recognized as safe). Why doesn’t the FDA review the research and officially confer the GRAS designation?
DA: When a firm submits a GRAS self affirmation, the FDA issues an opinion. To do that, FDA scientists review the science. The opinion may be “no questions” – they take it as being OK. Or “we have questions” [means] we’re not comfortable with what you’re doing. So there is already a review process when someone submits a GRAS petition. There is not a requirement for a firm to submit a GRAS petition, but they choose to do it because if they get an affirmation from FDA, they are free and clear. If they don’t do it, put a product on the market and we find out, check it out and find a problem, they are dealing with a recall and all sorts of headaches. The most expeditious way is to submit a GRAS petition, but it’s not a requirement.
FP: Some say the FDA is not doing enough to ensure food safety, but isn’t it ultimately the responsibility of food companies to ensure the ingredients in their products, no matter where ingredients come from, are safe?
DA: Industry has a responsibility to produce safe food – from farm to table. Anyone who’s handling food has the same responsibility, whether you are a farmer, preparing food for the family, or anyone in between. The expectation for FDA is that we will set the standards and ensure those standards are being met through some program of preventative controls, which we validate, through inspection and sampling, and when things go wrong get on it quickly. It’s a team effort. The ultimate responsibility for producing a safe product is with industry. FDA’s responsibility is to oversee that, make sure companies are setting the right standards – FDA’s standards -- ensuring they comply, and when they don’t, getting in there and taking care of business.
FP: Some in Congress are calling for a single food agency. Do you think that is a good idea?
DA: It depends how it’s done. USDA and FDA are the primary food safety agencies; USDA – meat, poultry and egg products and FDA – everything else, and there are other agencies that do things around food; no question about that. The statutes and laws that control USDA and FDA are very different. The biggest concern about creating a single food safety agency is that if you do it by just moving the boxes around, there would be no point. To do it right, you’d have to come up with an approach that builds a new infrastructure with new statutes and laws that integrate the two. You’d have to make sure it was adequately resourced and had adequate authority. Then there would be more logic to a single agency. But there’s no guarantee it would work better or that food would be safer. That’s the downside. Food safety is an ongoing, continuous problem, and during the reorganization of a single agency there would be a period where I’d be concerned we’d have greater risks because essentially what you’re doing is reshuffling the deck. You’re taking apart systems that work to create one you hope will work. Other countries, which don’t have such sophisticated food systems, have done this. No one would design it from scratch the way ours is, but it’s evolved over 100 years to be what it is. There are pros and cons to a single food agency, but the bottom line is if it’s not done right, I think it would make foods less safe.