The NGFA commended members of Congress for urging the U.S. Food and Drug Administration (FDA) to correctly interpret the “solely engaged” exemptions that apply to grain elevators under its Food Safety Modernization Act (FSMA) rules for human and animal food.
The NGFA has been urging FDA to revise its current interpretation of the “solely engaged” exemptions to avoid imposing unnecessary, inappropriate and costly regulatory requirements on grain elevators that are located on the same premise as a feed mill or other grain processing plant. Under FSMA, FDA is authorized to grant a science- and risk-based exemption from FSMA’s requirements that facilities comply with current good manufacturing practices, conduct hazard analyses and implement preventive controls and extensive recordkeeping for facilities that are engaged solely in the storage of grains and other raw agricultural commodities other than fruits and vegetables.
During the rulemaking process FDA concluded that “outbreaks of illness associated with…agricultural commodities…have not been traced back to storage facilities solely engaged in the storage of raw agricultural commodities” and that “there would not be significant public health benefit to be gained by subjecting facilities that solely store non-fruit and vegetable raw agricultural commodities intended for further distribution or processing [to such] requirements.”
However, contrary to FDA’s own reasoning and the statutory language that provides for an exemption for facilities storing raw agricultural commodities (except fruits and vegetables), the agency has deemed that grain elevators lose that exemption merely if they are located on the same premises as a feed mill or grain processing plant that is subject to such regulations. Meanwhile, a grain elevator performing the exact same storage-related activities, but located across the street on a different property, is exempt. In their June 21 letter to FDA Deputy Commissioner for Foods and Veterinary Medicine Frank Yiannas, the lawmakers said that this represents a misguided approach.
“The current interpretation by FDA is contrary to a science- and risk-based approach to protect public and animal health and imposes an unnecessary economic burden on grain elevators,” wrote Sens. Jerry Moran, R-Kan.; James Inhofe, R-Okla.; John Boozman, R-Ark.; Pat Roberts, R-Kan.; Deb Fischer, R-Neb.; John Hoeven, R-N.D.; and Kevin Cramer R-N.D.
The lawmakers’ letter to FDA cited NGFA’s conservative estimate that it costs between $57,000 and $127,000 per facility to comply with FSMA’s human and animal food rules.
“FDA should revise its current interpretation of the “solely engaged” exemptions in its human food and animal food rules to acknowledge that distinct and separate activities (e.g., storage versus manufacturing operations) may occur at the same geographic location, and grant the exemption to grain elevators engaged solely in storage-related functions,” the lawmakers note in the letter.