Sofie E. Miller
Cassidy B. West
FDA’s proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption does not meet statutory and executive requirements, and may needlessly harm consumers as well as small farmers domestically and abroad. First, estimates supporting the rule are based on very limited data and unscientific methods. FDA nevertheless relies on point estimates, rather than presenting a range of likely effects. Second, FDA does not consider unintended side effects associated with higher prices for the fresh commodities covered. Third, even accepting FDA’s analysis at face value, the selected option does not maximize net benefits as required by presidential Executive Orders 12866 and 13563. The recommendations below would address some of these issues in the proposed rule and analysis.
Exempt Farms with Annual Sales less than $100,000
FDA is both authorized by the statute to provide small farms with additional flexibility, and instructed via Executive Order to maximize the net benefits of its rule. The exemption threshold proposed in this rule neither provides small farms with this flexibility nor maximizes net benefits. Based on the agency’s own analysis, exempting all farms smaller than $100,000 would maximize net benefits while also providing additional flexibility for small farms.
Remove ETBS Standards
Because of the relatively high cost and low benefit of the standards for equipment, tools, buildings, and sanitation, FDA should remove these standards from its rulemaking. Despite contributing the least to overall contamination risk, FDA’s proposed standards for equipment, tools, buildings, and sanitation have the highest cost per illness avoided. FDA and farm resources would be better directed toward standards to reduce more tangible risks, such as worker health and hygiene and agricultural water.
Use of Ranges Instead of Point Estimates
Despite very significant uncertainty in both the baseline estimate of risk from foodborne illness and the reductions achievable from implementing the measures proposed in this rule, FDA provides single point estimates of benefits and net benefits. Given the limitations regarding data and methodology used in its baseline estimate and limited information regarding how contamination occurs, FDA should be more transparent about the uncertainty underlying the baseline risk of foodborne illness used in this rule.
Reliance on a single point estimate of the efficacy of this rule implies a degree of certainty FDA does not have, and may misrepresent the benefits of the proposed standards. While it would be preferable for the agency to rely on existing literature and experiments to gauge the likely efficacy of the standards, the available data could be improved by using a range of benefits rather than a point estimate. Using its own survey results, FDA should calculate a range of benefits resulting from reducing foodborne illness by between 42 and 88 percent. This range is more likely to contain within it the actual efficacy of the standards than a single point estimate for efficacy and benefits.
FDA should add language to its final rule committing to measure efficacy at two-year increments following implementation of the rule, measured as percent reductions in foodborne illnesses. This information will tell both the agency and the public how accurate its estimates were, and will provide information for future rulemakings on how to tailor standards to achieve desired outcomes. In addition, retrospective review efforts may be able to provide information on whether the small business exemption was appropriate for maximizing net benefits. If the retrospective reviews indicate that FDA’s standards were ineffective, FDA should consider a rulemaking to change the standards to best reflect the lessons learned.