Implementation of new food safety law will take timeMay 20, 2011
Harrison Pittman, director, UA National Agricultural Law Center
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Dave Edmark, Division of Agriculture Communications
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FAYETTEVILLE, Ark. — A new food safety law went on the books in January, but much more remains to be done before its full effect is felt. Specific regulations authorized by the law are still to be written over the coming months and years. Memoranda of understanding with other government agencies will be drafted. Perhaps most importantly, funding of the law’s provisions will need to be determined by Congress each budget cycle.
The Food Safety Modernization Act applies to food regulated by the Food and Drug Administration – everything except meat, poultry and eggs, which are covered under U.S. Department of Agriculture rules. One significant aspect of the new law is that it approaches preventive measures similar to USDA’s regulation of products.
“There’s a clear parallel,” said Harrison Pittman, director of the National Agricultural Law Center, a unit housed at the University of Arkansas School of Law that operates under the statewide U of A Division of Agriculture. Since the mid-1990s, USDA has required processors under its jurisdiction to develop Hazard Analysis and Critical Control Point (HACCP) plans that outline what in-house steps are being taken to prevent and control contamination before a product leaves the plant. The new FDA law has a similar requirement.
All facilities governed by the law must be registered on a two-year basis. “The law gives FDA the authority to suspend or revoke the registration, which in effect would put it out of business,” Pittman said. “You couple that with a new provision that has changed from voluntary recall authority on FDA’s part to mandatory recall authority.”
The new FDA law is targeted at situations in which foodborne illness has been discovered after a food product has left the processor. Previously, Pittman said, there was no provision allowing for mandatory recalls. Instead, FDA would coordinate with and encourage the company to voluntarily recall the product. FDA’s leverage was that it could also inform the company that it would publicize the discovery of contamination if the company didn’t recall the product. Pittman explained that “FDA has made clear it wants to continue to use the voluntary recall approach, but reserves the right to use mandatory recall if the situation arises.”
“It gives consumer groups and watchdog groups the ability to put pressure on FDA,” Pittman said of the authority to order recalls. “If there’s an outbreak they can say, ‘You have this authority. You should use it.’ It’s definitely an added tool in terms of foodborne outbreak.”
One major change in the law is its requirement that high-risk plants must be inspected within five years of the law’s enactment and every three years after the first inspection. These inspections will give FDA access to the facilities’ records in cases where it believes a product could cause series health problems.
Pittman said this provision places the FDA in a more proactive position than previously and more power to perform inspections. “This is supposed to be proactive and science-driven and as part of that they’re supposed to allocate time and resources toward facilities and food products that are known scientifically to have a higher risk or have a history of particular problems,” Pittman said.
The law exempts smaller operations from certain requirements, such as farmers who sell less than $500,000 worth of food annually and who sell to farmers markets or restaurants. Pittman said congressional supporters of the exemption argued that foodborne illness outbreaks from such plants are likely to be localized events. He said the issue might be revisited if a future foodborne illness outbreak is traced back to an exempted small food processor that engages in direct marketing.
FDA authority over imported food now extends to the right to inspect foreign facilities that are making products bound for the United States. “The new import requirements are some of the most important provisions in the new law,” Pittman said. He added, “Like other aspects of this law, though, much remains to be seen in terms of funding and, therefore, regulatory implementation.”