New FDA law means end to status quo
Feb. 24, 2011
With President Barak Obama signing a bill overhauling in a major way food safety in the US for the first time since the Great Depression more than 80 years ago, there is another task waiting to be accomplished: finding enough money in the federal budget to pay for it. Funding this new legislation is just one of the challenges facing the federal government and the Food and Drug Administration, as they get ready to implement the 2010-2011 Food Safety Modernization Act (FSMA).
This legislation directs the FDA, working with a number of public and private partners, to build (for this agency) a brand new system of food-safety oversight. The FSMA is focused on applying science and common sense to prevent food-safety problems, including pathogens and other dangers that can make people sick. Before this can happen, there is one obstacle that can be standing in the way — a lack of money to implement the new law. And there is some Republican opposition in Congress to the amount of money needed to implement all the legislative provisions.FDA revamped?
So now it is falling to industry groups who supported the new legislation, consumer groups and others to convince the new Congress to provide additional funding to the FDA for the FSMA to be enforced. It's a problem because the Republicans have a goal to cut government spending — not to increase it. According to the Congressional Budget Office, the new food-safety measures will cost the government about $1.4 billion during the first five years, including the hiring of an additional 2,000 food-safety inspectors. But according to a Georgetown Univ. study last year, foodborne illnesses cost the US $152 billion a year in lost productivity, medical costs and other expenses, not counting food industry costs when a product is recalled. With the concerns about food safety over the past few years, particularly concerns about how FDA carries out food-safety inspections and its other activities, it is hard to believe the money for the new food-safety program won't be there.
What the FSMA sets in motion is a process to change the way FDA carries out its food-safety responsibilities. One of the goals of the legislation is to make FDA food-safety activites more like USDA's. Even with the changes coming from the new law, the two agencies will not operate identically.
FDA has the responsibility for regulating about 80 percent of the food supply in the US, although some of those activities are delegated to state agencies. The remainder of the food supply, including meat, poultry and some egg products, are under the control of the USDA, with a small part of those activities also carried out by state agriculture departments.Operating differently
The two agencies operate in different ways, and will likely continue to do so. FDA's responsibilities will be changed from reacting to food-safety problems to preventing outbreaks in the first place, which is what USDA inspections are more geared to do. According to the Government Accountability Office, FDA has been going into food plants for inspection on the average of about every 10 years, although in many cases I'm aware of, FDA has visited plants more often, every two or three years, which is still not all that frequent. In contrast, USDA inspectors are required to be in meat and poultry plants every day the plant is operating, while the plant is slaughtering or processing meat or poultry.
Making the two agencies more similar in operation will be quite a challenge. While FDA requires seafood plants to use a Hazard Analysis and Critical Control Point (HACCP) system to prevent food-safety problems, it will now require other food processors to develop similar plans to prevent contamination and to test them.Recall repercussions
A major piece of the law gives FDA the power to require recalls, rather than asking food companies to recall suspected contaminated food voluntarily. FDA will also have access to records at food production facilities and farms. the law will require increased inspections of food processing operations and farms but unlike USDA meat and poultry plants, some very small facilities are exempted from the new law. It would also require the FDA to visit "high risk" establishments, where there is more danger of adulteration, once every five years at first, and then once every three years. Importers would have to verify imported products meet US safety standards.
Because the new legislation allows FDA to require plants to recall, there are concerns that USDA's Food Safety and Inspection Service will eventually be forced to change its method of operation to require meat and poultry plants to require recalls as well. If this were to happen, it would be a major change in the way USDA regulates the poultry and meat industry, and could lead to additional regulatory changes in the future.