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.