FARGO, N.D. -- North Dakota government organizations are trying to help the state's food companies get ready to comply with new and emerging rules from the U.S. Food and Drug Administration.
In 2011, Congress passed the Food Safety and Modernization Act. The act directed the FDA to apply stronger food safety risk prevention standards for all food processing -- beyond the meat and poultry products that already have them.
David Saxowsky, a North Dakota State University associate professor in the Agribusiness and Applied Economics department in Fargo, says the expanded standards are similar to a license system called Hazard Analysis and Critical Control Point Practices. Essentially, HACCP calls for "documented preventative controls" against contamination of food products.
As an example, Saxowsky says expanded FDA rules for the first time would apply to a company that cleans soybeans and puts them into a bag for direct consumer consumption. The rules are designed to minimize risks in food adulteration or contamination.
"It's about how they can minimize the risks," Saxowsky says. "The companies need to make plans and document things on an ongoing basis."
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It'll likely be two years before companies need to comply with the rules, but they need to start thinking about them. The FDA published its first of two sets in January. A 120-day comment period runs through May 16. Saxowsky says it isn't clear how much compliance will cost.
Educating those affected
Organizations are trying to create more awareness of the changing standards. On Feb. 19, the North Dakota Trade Office, the North Dakota Department of Agriculture and NDSU included the issue on a panel at their Global Business Connections conference in Bismarck.
NDSU is scheduling two half-day sessions on the topic -- April 8 at the Carrington Research Center and April 12, at the Red River Valley Fairgrounds. Both sessions start at 1 p.m., Saxowsky says.
Also, on March 12 and 13, NDSU will host the first of two workshops with Rob Maddock, an NDSU associate professor of animal sciences, who has experience in the HACCP-like rules already in place for meat. The second workshop has not been scheduled.
The FDA has issued two sets of several expected proposed regulations to implement the act. The two involve produce safety and preventive controls for other categories. The act calls for good manufacturing, packing and handling practices, as well as "risk-based preventative controls."
Dave Phillips, a feed specialist with the state agriculture department, says the state has eight feed manufacturers that are already FDA-regulated. Most are in the west and southwest part of the state. All of those companies manufacture feeds that include some medication that requires a withdrawal period at the lowest use rate, or have some kind of carcinogenic property. About 60 commercial, state-licensed feed manufacturers that may have to meet expanded standards operate in the state. Among those are ethanol companies that produce distiller's grains.
FDA has said that if an entity is just receiving a commodity, storing it and moving it on, it exempt. That includes grain elevators, Phillips says.
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Kenan Bullinger, director of the North Dakota Health Department's Division of Food and Lodging, says many of the state's larger companies that produce food for human consumption (sugar beet companies, pasta and some larger bakeries, among others) are already under FDA inspection jurisdiction because of their interstate distribution of product. Bullinger says companies that do "special process at retail" -- things such as smoking, curing and vacuum-packing -- also have special rules.
Bullinger says he doesn't know how many other companies might be affected. But he says it's hard to educate people about the new rules because they're not yet final.
"It's a waiting game," he says. "You can talk about the act, as it passed Congress, but only two -- produce standards and risk-based preventive controls for human food -- have come out."
