On Jan. 4, President Obama signed the FDA Food Safety Modernization Act of 2010, the first major reform of the nation's food safety laws since 1938.
Supported for the most part by the food industry's trade groups, the bipartisan legislation gives the Food and Drug Administration more authority to oversee a food supply chain that has been wracked by a number of high-profile outbreaks of foodborne illness involving produce, peanut products and other foods. The Center for Disease Control estimates that 48 million Americans fall ill to a foodborne illness every year; of those, 180,000 are hospitalized and 3,000 die.
The essence of the new law, estimated to cost $1.4 billion over five years to implement, is to be proactive rather than reactive, especially with foods considered high risk. “This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply,” said Margaret Hamburg, commissioner of the FDA. It won't, however, apply to meat, poultry and egg products, which fall under the purview of the U.S. Department of Agriculture.
Fresh from the president's desk, the Food Safety Act has to navigate more than a dozen rulemakings and at least 10 guidance documents before yielding final regulations, a process that will take more than three years. But some of the law's provisions will take effect immediately, and those provisions as well as the ultimate rules will have a pronounced impact on the operations of both food distributors and suppliers.
The Food Marketing Institute, Arlington, Va., and other trade groups will be working closely with the government during the rulemaking process while helping the industry adjust to the law's new realities. “I believe the FDA has shown a willingness to listen to and collaborate with the food industry,” said Jill Hollingsworth, FMI's senior vice president and head of its new Center of Excellence for Food Safety and Protection. “The best way to see the legislation become a reality is letting industry and government work together to implement it.”
That process will go forward despite rumblings in Congress that funding for the legislation may be curtailed. FMI “is not engaged in the funding issue,” said Hollingsworth. “We're just looking at the provisions and what we as an industry have to do.”
The provision of the Food Safety Act with the most direct impact at the store level has to do with providing shoppers with detailed information on recalled products. This starts with a requirement that manufacturers submit “additional information” to the reportable food registry, a year-old FDA database to which suppliers must submit electronic reports within 24 hours of learning it has shipped potentially harmful food. Designed to inform consumers, the additional information will include a description of the food, container size, product ID codes and contact information.
Equipped with that information, the FDA will be required to publish a one-page summary on its website, and retailers with at least 15 stores will need to prominently display the summary within 24 hours and for 14 days. Spots in the store where it can be posted — such as the checkout area and shelves — will be determined in rulemaking, with final regulations released in 18 months.
The information, which FMI worked with Congress to develop, will help consumers “determine if the product they have is a recalled product,” said Hollingsworth. FMI is also collaborating with the FDA on where recall notices should be placed in stores. Though the law applies to retailers with 15 or more stores, it “may become an industry best-practice” that smaller operators would adopt, she said.
One of the immediate authorities given to the FDA by the law is the power to mandate recalls, though “everyone believes that it will rarely if ever be needed,” said Hollingsworth. She believes that the recall system already used by the FDA and the industry works. “The goal is to make it work more rapidly,” she said. The Rapid Recall Exchange, established by FMI and GS1 US, has helped that process, serving as “an easy way to transmit information consistently,” she noted.
Other parts of the Food Safety Act have more to do with the distribution centers and manufacturing plants operated by retailers, wholesalers and manufacturers. Those companies have had to register their DCs and manufacturing sites with the FDA since the Bioterrorism Act was passed in 2002, but under the new law they will have to update registration every two years, between October and December of even-number years (2012 being the first). “A lot of companies come and go, so one-time registration was not very productive,” said Hollingsworth.
Starting in mid-2012, companies will be required by the Food Safety Act to put down in writing a comprehensive food safety plan that looks at hazards and preventive controls in their registered facilities. For retail and wholesale DCs, this would cover areas like good sanitation and temperature control of perishables. “Most DCs do have plans in place to maintain the integrity of perishables,” noted Hollingsworth. “The difference now is that those systems and controls have to be in writing and available for inspectors to review.”
In regard to seafood handling, prior FDA regulations require that HACCP (Hazard Analysis and Critical Control Points) food safety procedures be used. FMI plans to work with the FDA to make sure that HACCP continues to conform to what the agency expects in the new law for preventive controls, Hollingsworth said.
Publix Super Markets, Lakeland, Fla., uses food safety procedures at DCs and manufacturing plants that the chain believes will meet the new law's requirements, said Shannon Patten, the chain's media and community relations manager, in an article this month in the Tampa Bay Business Journal.
Asked by SN to describe those safety procedures, Patten said they include “good manufacturing practices (GMPs)” as well as HACCP. These programs encompass “regular risk assessments of food safety programs that are conducted by our corporate quality assurance department in addition to third-party assessments,” she said.
Publix recently expanded its food safety programs to include the Safe Quality Food certification programs overseen by FMI's SQF Institute. The risk assessments and SQF certification audits are also applied to Publix's private-label manufacturers as well as CPG brand manufacturers.
Last year, Robert Mooney, group vice president, distribution and manufacturing, Meijer Inc., Grand Rapids, Mich., said that the chain was preparing to meet any new federal food safety law by pursuing SQF certification for its DCs and manufacturing facilities. During 2010, Meijer achieved SQF certification for five facilities, including bakeries, a perishables warehouse and a few vegetable processing facilities, said Meijer spokesman David Peterson. But the “jury's still out” as to whether the certifications meet the exact requirements of the new law, he said.
The written plans put into effect by food companies will also have to address prevention of intentional acts of food contamination. FMI is working closely with the Department of Homeland Security's food and agriculture sector and the FDA to determine what retailers should do to minimize those risks in areas such as transportation (which is also subject to new rules regarding sanitation). The FDA will issue guidance on this within a year, and regulations within 1½ years. “We've not had [intentionally] bad things happen with food, and that might make you complacent,” said Hollingsworth. “Let's not let our guard down.”
Publix has also worked with the FDA and Homeland Security over the last few years on the development of food defense programs, noted Patten.
Another provision of the law impacting food retailers is one calling for the FDA to conduct pilots on track-and-trace systems over the next six months for both produce and packaged goods, report to Congress on the findings within 18 months, and ultimately establish a traceability system.
The intent is to go beyond the traceability system devised by the Bioterrorism Act, which asks companies to record the party that provided foods (one step back) and the party to whom they were sent (one step forward). “Now it's a matter of making sure all the steps fit together,” said Hollingsworth.
Hollingsworth expects the FDA to consider the Produce Traceability Initiative, which trade groups, retailers and suppliers have been working on over the past few years.
“We would love to see the PTI used as a model for produce traceability,” said Kathy Means, vice president of government relations and public affairs for the Produce Marketing Association, Newark, Del. “The FDA doesn't take existing programs, but PTI's principles should fit into the FDA's program.”
The United Fresh Produce Association, Washington, wants the FDA's traceability system to “allow for the utilization of a PTI-based model for those produce companies that would like to incorporate this type of system into their business plans,” said Robert Guenther, senior vice president, public policy, United Fresh. “But PTI should not be the only system applicable for produce.”
The law's call for traceability systems is opening the doors to technology companies, such as Aldata and IBM, that can provide systems to track the outbreaks of foodborne illness. Other aspects of the law are providing opportunities to vendors such as Delta Technology & Software, Morrisville, N.C., which is marketing a new system that gives retailers immediate access to the results of lab tests on food.
Hollingsworth pointed out that if some funding is withheld from the FDA for implementation of the new law, it would mostly affect the inspection requirements. Under the law, FDA's risk-based inspections of domestic and foreign facilities, including greater access to records, will become more frequent, noted Kristen Vieira Traynor, global food safety leader for PwC, New York.
But there are ways to mitigate the inspection burden. Domestically, that could include FDA's partnership with state and local inspectors. The agency has also expanded the role of third-party auditors, who would be authorized to certify the safety of some imported foods. (All imported foods will be subject to verification that they were produced in compliance with U.S. laws.) To that end, the FDA plans to recognize accrediting bodies that evaluate and accredit third-party auditors.
One example of an accrediting body is FMI's SQF Institute, which is part of the Global Food Safety Initiative, a global group of accrediting bodies. “Accredited audits add eyes and ears to look at what companies who produce food are doing,” said Hollingsworth, who was previously group vice president, food safety for the SQF Institute.