Small Businesses Tip the Scales for FSMA Exemptions

The draft produce rule also excludes any produce that is considered low risk with respect to biological hazards. Examples include produce that is rarely consumed raw, such as potatoes, or that will undergo processing that includes a kill step, such as green beans intended for canning. The proposed rule also does not apply to produce for personal or on-farm consumption.

The rule, which is open for public comment until May 16, 2013, exempts farms having less than $25,000 in average annual sales. According to the FDA, 40,496 domestic farms (including 285 sprout farms) will be fully subject to FSMA rules. Fully or partially exempt would be 75,716 farms that fall under the Tester Amendment provisions and 34,433 farms having less than $25,000 in sales. By this count, 73 percent of all U.S. produce farms would be fully or partially exempt from FSMA requirements. However, FDA notes that, as a group, food businesses with less than $500,000 in annual sales produce less than 1 percent of all U.S. food by dollar value.

Small farms that do not come under the Tester Amendment would be given extra time to comply with FSMA requirements. Sixty days after a final produce safety rule is published in the Federal Register, non-exempt “small businesses” (those with less than $500,000 in annual sales) would have three years to comply with requirements. “Very small businesses” (those having less than $250,000 in annual sales) would have four years to comply, while other businesses would have two years. The smallest farms, those having less than $25,000 in sales, are exempt.

“We know one-size-fits-all rules won’t work,” said Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine, when the rules were published back in January. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food ­system,” he said.

Others are not so sanguine.

“Income has no relationship to risk of bacterial contamination,” says David W. Plunkett, senior staff attorney at the Center for Science in the Public Interest in Washington, D.C. “Therefore we see absolutely no reason to suppose that these [small] facilities and farms are inherently safer than larger facilities and farms. One likely result of the Tester Amendment is that food from Tester facilities and farms will begin to bear a disproportionate share of the illness burden,” Plunkett tells Food Quality magazine. “We can’t ignore the fact that Tester weakens FSMA’s effectiveness at preventing foodborne disease.”

Preventive Control Rule

A bit more complicated are small businesses exemptions in the proposed preventive control rule. In general, the rule would require facilities that manufacture, process, pack, or hold food to register with FDA. Unless exempted, these facilities must have a hazard analysis and preventive controls plan in place. (Farms are generally not required to comply unless they are a “mixed use” facility that also employs a processing activity, for example, chopping vegetables.)

The preventive control rule would establish modified requirements for “qualified facilities”—that is, facilities that either meet the Tester Amendment definition for business size and customer base, or that are “very small” businesses. For the latter, FDA is proposing three different categories and is requesting comment on each. The options are average annual revenues of $250,000, $500,000, or $1 million.

However defined, these very small facilities and the Tester Amendment-level firms would only be required to certify that they have identified potential hazards associated with the food being produced and are implementing and monitoring preventive controls measures. Alternatively, they could submit documentation that they comply with a state, local, county, or other non-federal food safety law, including relevant laws and regulations of foreign countries. In either case, they wouldn’t have to submit any actual plans.