Small Businesses Tip the Scales for FSMA Exemptions

FDA estimates that about 97,646 domestic food manufacturers, warehouses, and wholesalers would fall under the preventive control rule. If the exemption were set at less than $250,000 in annual sales, FDA says 46,097 of these firms, or 47 percent, would be exempt from hazard analysis and risk-based preventive controls. If set at less than $500,000, 57,411 or about 59 percent would be exempt, and if less than $1 million, 74,985 or about 77 percent of the firms would be exempt.

Like the produce safety rule, FDA is accepting comments on the draft rule until May 16, 2013. Sixty days after publication of a final rule, large facilities will have one year to comply with requirements, while non-exempt small businesses would have two years and non-exempt very small businesses would have three years.

“I’m not sure it makes that much difference whether a firm has $250,000 or a million dollars in sales,” says Acheson. “But part of the reason FDA is asking for comment is if they get an overwhelming response saying to make the definition as stringent as possible, it gives them cover to do so. If they don’t get it, they will stick to where the comments lead them.”

Both Acheson and Plunkett wish that small businesses had been treated differently.

“If I were calling the shots and had the resources, I would be putting preventive controls requirements on all small businesses irrespective of size if they ship through interstate commerce,” Acheson says. “But I would also build robust programs to educate and train the small producers. The challenge is that many of them are not sophisticated enough to understand what they need to do.”

Plunkett believes that all food processors should conduct science-based assessments of risk and implement preventive measures. “The rule should be structured to accommodate size without overlooking mitigation or elimination of risk,” Plunkett says. “There is a logical lapse in Tester’s assumption that a processor who can’t afford to implement reasonable preventive measures is somehow going to always produce safe food.”

Agres is based in Laurel, Md. Reach him at [email protected].