FSMA requires FDA to initiate rulemaking on enhancing the tracking and tracing of “high-risk” foods to evaluate
whether additional recordkeeping requirements would assist in preventing or mitigating outbreaks of foodborne
illnesses. FDA has yet to define “high-risk” foods, but when doing so is required to consider known safety risks of
a food based on foodborne illness data and the likelihood that a particular food has a high potential risk for
contamination. FDA has conducted two pilot projects pertaining to enhanced traceability of foods, and has sought
comments on recommendations emanating from the projects.
Importantly, FSMA expressly prohibits FDA from imposing recordkeeping requirements that would limit the
commingling of raw agricultural commodities (except raw fruits and vegetables), a legislative provision that the
NGFA assisted in drafting. Further, FSMA states that facilities handling such raw commodities (like grains and
oilseeds) on a commingled basis are subject to the existing Bioterrorism Act requirement to maintain records
sufficient to identify the immediate previous source and immediate subsequent recipient of the commodity(ies).
Thus, it is anticipated that the law’s potential enhanced product-tracing and recordkeeping requirements will have
a negligible, if any, impact on facilities storing raw grains and oilseeds, as well as on most manufacturers of feed
and feed ingredients – given the requirement that it be applied only to “high-risk” products.
