Response of FDA to questions about their inspections in 2014 at Missouri Produce Auctions

Published: August 1, 2015

By: FDA/CFSAN Produce Safety Staff, including Tywanna Paul

Specifically, why FDA collects produce samples at “auctions” and “road side stands”. Why FDA was collecting samples at the produce.

Within the past year, FDA has not conducted any sampling assignments specifically targeting select produce commodities sold at produce auctions. However, as part of general domestic produce sampling assignments, some samples may have been taken by FDA at produce auctions.

FDA collects and tests samples for a variety of purposes, such as for research to answer particular questions and to fill data gaps, to test for the presence of chemical residues, or to test for the presence of microbial pathogens. An example of a recent sampling assignment involved collecting and testing domestically-grown produce to collect information on the presence of targeted foodborne pathogens in fresh commodities such as lettuce, cilantro, cucumbers, and spinach, to name a few. One sampling assignment goal includes expanding surveillance of fresh produce by typically collecting samples as close to the farm as possible. Other goals of FDA’s produce sampling assignments include: to sample a broader range of produce items to obtain or add to baseline data regarding the incidence of contamination with pathogens; to assist in identifying conditions and practices that could lead to, or spread contamination; and to protect public health by taking appropriate regulatory action on product lots found to be contaminated.

FDA has used data from sampling assignments in the past to analyze for trends, identify vehicles associated with foodborne illness outbreaks, identify conditions and practices likely to cause contamination through followup inspections, and to help prioritize research needs as well as outreach & education to industry. Results from past sampling assignments have not been traditionally made public. However, FDA is currently transitioning to a new approach for microbiological sampling that involves collecting a statistically significant number of samples over a shorter period of time, to better inform risk analyses and decision making. As part of this pilot, FDA plans to begin publishing summaries of assignment findings on the FDA website.

Currently, produce auction houses are typically required to register as food facilities under section 415 of the Federal Food, Drug, and Cosmetic Act, unless an exemption from the facility registration requirement applies. In general, food facilities required to register would be subject to the requirements of the proposed Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation when that regulation is finalized, unless an exemption from that regulation applies. In addition, on September 29, 2014, based on its outreach efforts and public comments, FDA issued published proposed revisions to this proposed rule and had accepted comments on the revisions until December 15, 2014.

General Background on FDA’s Sampling and Testing of Produce (why, when, how and results)

At any given time throughout the year, FDA typically has a variety of sampling assignments underway, occurring simultaneously. FDA sample collection assignment timeframes can vary, but usually are twelve months in duration. Data analysis typically occurs after an assignment has been completed and after all test results have been compiled.

For more information, please go to: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm.