By Sarah Gonzalez, Director of Communications and Digital Marketing
The NGFA this week urged the U.S. Food and Drug Administration (FDA) to revise its draft guidance to clarify that grain elevators that solely store and handle raw agricultural commodities are exempt from certain Food Safety Modernization Act (FSMA) requirements, as permitted under the law, regardless of whether they are located on the same premises as a feed mill or grain processing plant that is subject to such regulations.
The recommendation was among several made by NGFA in a statement submitted on April 18 to FDA in response to the agency’s draft guidance that is designed to assist facilities in determining whether they are exempt from certain FSMA requirements.
FDA’s draft guidance, when finalized, is intended to help facilities determine whether they are ‘‘solely engaged’’ in certain activities that are exempt from some or all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 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. 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“We believe that FDA should make several changes to its current interpretations and the draft guidance so that (current good manufacturing practice, hazard analysis, and risk-based preventive controls) requirements are applied in a manner that better reflect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 NGFA Senior Vice President for Feed Services David Fairfield in the statement to 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 recommended that 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” and more appropriately focus regulatory requirements on risks that pose a risk to human or animal health.
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.
FDA issued a broad request for comment in September 2017 to assist the agency in identifying regulations that it could modify, repeal or replace to reduce regulatory burdens. The NGFA’s recommendations regarding the “solely engaged” exemptions were part of several existing regulatory requirements the association outlined that could be changed or eliminated to reduce regulatory burden on the grain, feed and processing industry, while still preserving FDA’s ability to fulfill its public health responsibilities.