PT.3.4 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Once the product tracing pilots are completed, and other data are gathered, the Agency will begin the development of a proposed rule.
PT.3.5 Will FDA expand requirements for recordkeeping requirements to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.
PT.3.6 Will FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance?
FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods.
TK: What do readers think? Is PTI still on track? Is "buyer-centered implementation" actually working, or merely bluster? What is the future of PTI as it relates to FDA recordkeeping requirements on high risk foods?