Dr. David T. Ingram
U.S. Food and Drug Administration, USA
Title: Title: Biological Soil Amendments of Animal Origin (BSAAO) in Fresh Fruits and Vegetable Production: A Regulatory Perspective
Biography
Biography: Dr. David T. Ingram
Abstract
When the FDA first proposed the Produce Safety rule mandated by the FDA Food Safety Modernization Act (FSMA) in 2013, the proposed criteria included a nine-month interval between the application of raw manure (and other untreated BSAAOs) and the crop harvest when certain application methods are used. Many growers and other stakeholders in the produce industry objected, focusing on the limitations of the data on practices across the U.S. and internationally. Organic growers specifically expressed concern about the differences between the proposed application interval and the USDA National Organic Program standards for raw manure application intervals. In response, the FDA decided to reserve a decision on the minimum application interval and to conduct additional research and a risk assessment, which can evaluate the impact of interventions that include the use of application intervals. This change was included in the September 2014 supplemental notice for the produce rule and carried forward into the final version, which was issued in November 2015. In the meantime, we have placed restrictions on how raw manure is applied. The Produce Safety rule requires that covered farms not apply raw manure in a manner that contacts produce covered by the rule during application. And these farms are required to minimize the potential for contact after application. The future of FDA’s regulatory position on the current ‘reserved’ days-to-harvest restrictions on the use of untreated BSAAO has not yet been determined. Current findings of FDA’s risk assessment activities, as well as possible outcome will be discussed.