Food Safety Enhancement Act
The Food Safety Enhancement Act (H.R. 2749) passed on July 29, 2009 in the U.S. House of Representatives by a vote of 283-142. The bill gives the U.S. Food and Drug Administration new mandates and authority to regulate food safety of the 80%of the food supply that falls under its jurisdiction. The legislation addresses some of the gaping loopholes in the food safety program at FDA that were tragically exposed by a series of food borne illness outbreaks in recent years that sickened and even killed U.S. consumers. On balance, the bill is a positive first step to correcting the deficiencies at FDA, but there are still some issues that need to be addressed as the debate moves over to the Senate.
ABOUT THE BILL
- First, it would for the first time mandate an inspection frequency for FDA over foods it regulates. For high risk foods and food processors, the legislation mandates that FDA inspectors visit those processing facilities at least once every six to twelve months. For less risk foods and processing facilities, the bill requires that FDA inspectors visit those facilities once every 18 months to three years. For food warehouses, FDA inspectors would visit at least once every five years. There are currently over 150,000 domestic food facilities that fall under FDA jurisdiction. Under the current system, FDA inspectors visit U.S. food processors once every ten years. Farms would not be subject to this inspection frequency.
- Second, the legislation tightens the food safety standards for imported food products that fall under FDA jurisdiction. In its current form, the legislation requires FDA to conduct inspections of foreign facilities that export food products to the U.S. at the same frequency as domestic facilities. There are currently over 200,000 foreign facilities located in 150 countries that can export food products to the U.S. At the present time, FDA does virtually noon-site inspection of foreign facilities that export to the U.S and inspects less than 2%of imported food products at U.S. ports of entry.
- Third, it requires for the first time that laboratories that do product testing for food manufacturers be certified by the FDA. Currently, that is not a requirement and there have been cases where fly-by-night laboratories have been used by unscrupulous food processors to conduct microbiological testing to get their food products to pass.
- Fourth, the bill improves the ability of FDA inspectors to have access to food production records of food companies whenever they inspect their facilities. At the present time, FDA inspectors only have access to those records if they have reason to believe that adulterated food has been put into commerce. Had FDA inspectors had access to the records of the Peanut Corporation of America in 2006, 2007, and 2008, they might have prevented the salmonella outbreak that sickened hundreds of consumers and killed nine people.
- Fifth, the bill gives FDA mandatory recall authority should a company refuse to remove voluntarily contaminated products from the marketplace.
- Sixth, the bill requires food processors to develop food safety plans that can be scrutinized by FDA inspectors.
- Seventh, the bill calls for the development of produce safety regulations by the FDA that will be subject to public notice and rule making. The bill requires the FDA to take into account organic production standards and the impact that these regulations will have on diversified and small-scale farms and on wildlife habitat, conservation practices, and water-shed protection efforts.
- Eighth, the bill calls for the development of a food traceability system that cannot be fully implemented until there is successful completion of pilot projects and public meetings. The proposed traceability program will also be subject to public comment.
- Ninth, the bill calls for food processing facilities–both domestic and foreign–that put food into interstate commerce to pay an annual $500 registration fee to help pay for the cost of the enhanced food safety program at FDA. For example, a company that has 100 food processing plants that produce food under FDA jurisdiction will be required to pay $50,000 per year as a registration fee. Farms are generally exempt from paying the fee. Farms that process raw agricultural food products that are put into interstate commerce may be subject to the registration fee.
- Tenth, the bill does explicitly require the FDA to take into account, in its rule making, the impact on small businesses. It also exempts farmers who sell their products directly to consumers or restaurants from various requirements of the bill,such as the traceability requirements that could be developed.
- Eleventh, this bill does not cover food products or food facilities that are currently regulated by USDA under to Federal Meat Inspection, Poultry Products and Egg Products Inspection Acts. This includes meat, poultry, and other species that are subject to USDA or state meat inspection. Dairy production is also exempt.
There are still some lingering concerns over the impact that this bill will have on smaller processors and small farmers. The discussion on those issues will continue as the Senate takes up its version of a food safety bill later this year.