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Four years ago, Congress passed legislation aimed at enhancing the nation’s security and protecting its human food and animal feed supply. This month the final rule of the Bioterrorism Act dealing with food went into effect, possibly affecting some Ohio farmers.

Under section 306 of the Bioterrorism Act, some farmers and ag businesses are required to establish and maintain records that can be accessed by the U.S. Food and Drug Administration (FDA) if necessary. Those who place food directly in contact with its finished container also are required to keep records, according to FDA.

Having a trace-back system in place allows the FDA to more effectively deal with food-related emergencies such as contamination of food by terrorists, said John Wargowsky, Ohio Farm Bureau’s director of labor services and policy. Twenty percent of all trace-back probes are prematurely terminated because of insufficient recordkeeping, according to the FDA.

Large businesses covered by the rule had to start complying with the rule last year, and very small businesses with 10 or fewer full-time employees had until this month to start keeping records.

While most farms are exempt from the record-keeping provision, some aren’t.

"The process can be very confusing," Wargowsky said. "General production agriculture is exempt. When farms start doing non-farm activities, they usually lose that exemption."

Who must establish and maintain records? Domestic persons who manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons who transport food in the United States, and persons who place food directly in contact with its finished container, according to FDA. For these regulations, the term "persons" includes individuals, partnerships, corporations and associations.

Farms are exempt from the rule unless part of their business falls under the above definition of who has to establish and maintain records. An example could include a farmer doing some food processing or manufacturing in addition to production. For example, farm market operators and participants in farmers’ markets may not be exempt. Wineries are not exempt because they are considered a manufacturer. If a winery also grows and harvests grapes that are used to manufacture wine, then the growing facility may qualify for the farm exemption while the manufacturing activity would not, according to an FDA fact sheet.

According to the FDA, food is defined as "articles used for food or drink for man or other animals" and "articles used for components of any such article." Examples of "food" included beverages (including alcohol and bottled water), fruits and vegetables, fish and seafood, dairy products, raw agricultural commodities for use as food or components of food, canned and frozen foods, bakery goods, animal feeds and pet food.

The record retention period ranges from six months to two years depending on the type of business. The information can be kept in any format, paper or electronic.

Not complying with the rule can result in civil or criminal action by the federal government. The FDA does not specifically say what those penalties could be.

Both Ohio Farm Bureau and American Farm Bureau worked with federal officials to make sure that the guidelines were reasonable for farmers and others.

"Our take was that where there’s no risk, there should be no regulation," Wargowsky said.

To learn more about the recordkeeping rule or to see if your operation is affected by it, visit FDA’s Web site, www.fda.gov/oc/bioterrorism/bioact.html. Other options are to call the FDA at 800-216-7331 or 301-575-0156 or by faxing a request to 301-210-0247.