The NGFA made several recommendations to the U.S. Food and Drug Administration in comments it submitted on April 18 in response to draft guidelines to help facilities determine whether they are exempt from certain FSMA requirements.
The FDA’s draft guidance, when finalized, is intended to help facilities determine whether they are “solely engaged” in certain activities that are exempt from some or all requirements established within regulations implemented by the agency as part of FSMA.
The NGFA urged the FDA to change current interpretations that cause grain elevators to lose the statutory exemption from requirements to carry out current good manufacturing practices, perform hazard assessments and implement preventive controls merely because they are situated at the same general location as a feed mill or processing plant.
The FDA’s current interpretation and application of the “solely engaged” exemptions “are not consistent with congressional intent, are illogical and do not represent a risk-based approach to food safety,” the NGFA’s comments stressed.
“We believe that FDA should make several changes to its current interpretations and the draft guidance so that (current good manufacturing practice, hazard analysis, and risk-based preventive controls) requirements are applied in a manner that better reflect risks posed to food and feed safety,” wrote David Fairfield, senior vice-president of feed services for the NGFA, in the statement to the FDA. “We believe our recommendations, if implemented, would result in meaningful regulatory burden reduction while allowing FDA to fulfill its public health mission and statutory obligations.”
The NGFA also recommended that the FDA make modifications to its “facility” definition so it acknowledges the distinct and separate food- and feed-related activities that may occur at a given “facility.”
In its comments, the NGFA also noted that it “strongly disagrees” with the agency’s current position that pulses (dry peas, lentils, chickpeas, and dry beans) should be designated as “fruits and vegetables” or “produce,” which under FDA’s current enforcement policies make facilities storing or performing specified farm-related activities with such products subject to FSMA requirements.
In addition, the NGFA urged the agency to provide more examples within its final “solely engaged” guidance to further illustrate how the exemptions are to be applied, and address mixed-type facility scenarios.
