DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
College Park, MD 20740
February 25, 2013
The Food and Drug Administration (FDA) is issuing this letter to firms that grow, harvest, sort, pack, process, or ship cantaloupe, to further our common goal of enhancing the safety of cantaloupe. As we move forward over the next few years with implementation of the produce safety provisions of the FDA Food Safety Modernization Act (FSMA), it is essential that the cantaloupe industry and the produce industry in general, observe best practices already recognized by FDA and the industry as effective in reducing the risk of harmful contamination.
With this letter, we want to underscore the importance of these practices for the cantaloupe industry in light of recent outbreaks and pathogen positive sample findings associated with fresh cantaloupes. We previously issued a letter to the cantaloupe industry  (November 03, 2011) in response to a multi-state foodborne illness outbreak of listeriosis associated with the consumption of fresh, whole cantaloupe. We recognize that many cantaloupe industry organizations have taken actions to address food safety issues associated with growing, handling, processing, and distribution of whole and fresh-cut cantaloupe. We applaud efforts led by the cantaloupe industry that are aimed at enhancing cantaloupe safety.
This letter is intended to reiterate our concern regarding possible contamination of cantaloupes with Listeria monocytogenes (Lm) and other pathogens, particularly given the availability of new information since we issued the last letter. We want to highlight the critical importance of safe and sanitary production and handling of cantaloupe.
In 2011 and 2012, we responded to two major outbreaks traced to fresh cantaloupe and to one pathogen positive cantaloupe finding identified through expanded surveillance sampling following one of the outbreaks. One outbreak was the result of cantaloupe contamination with the bacterial pathogen Lm, and the second was the result of cantaloupe contamination with multiple serovars of Salmonella. In total, more than 400 people became ill and at least 36 individuals died as a result of these two outbreaks.
Our investigations in these outbreaks and in follow-up to an Lm positive cantaloupe sample result revealed, in part, multiple findings of insanitary production, handling conditions, and practices in packinghouses. We have since published findings we believe are contributing factors that most likely led to cantaloupe contamination with human pathogens at farms and packinghouses in a number of states.  More specifically, we performed an environmental assessment at the firm implicated in the Lm outbreak of 2011 and published a report of the assessment findings and recommendations to prevent the recurrence of a similar contamination event. We also performed an environmental assessment inspection at the firm implicated in the 2012 Salmonella outbreak and will publish a similar report with findings and recommendations.
Due to our observations at cantaloupe packinghouses, we urge the cantaloupe industry to review its current operations in the context of our guidance titled "Guide to Minimize Microbial Food Safety Hazards for Fruits and Vegetables" and our draft guidance titled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons,” which together recommend good agricultural practices (GAPs) and current good manufacturing practices (CGMPs) that growers, harvesters, sorters, packers, processors, and shippers can undertake to address common risk factors in their operations. We further encourage the industry to seek other available information, beyond that listed here, pertaining to pathogen reduction or elimination on fresh produce, including state and local government requirements or guidance and industry-led efforts to address food safety.
Because the recent outbreaks have been traced to domestic cantaloupe packinghouses, during the 2013 growing season, we intend to initiate inspections with a sampling component at a subset of the cantaloupe packinghouses in the United States. The aim of these inspections is in part, to assess the current practices by this segment of the produce industry and to identify insanitary conditions that may affect the safety of cantaloupe destined for distribution to consumers. In the event of adverse findings, we will take action as needed to protect the public health. We will continue to target imported cantaloupes at the border for sampling and may engage in other surveillance and inspection activities as circumstances warrant to meet our public health regulatory mandate and responsibilities.
We applaud the actions taken by many in the cantaloupe industry to address food safety issues. We are confident that the industry, including growers, harvesters, sorters, packers, processors, and shippers, will continue to work to provide safe cantaloupes to American consumers.
We continue to stand ready to provide technical assistance to the industry and to work collaboratively with our state partners, retailers, and others in pursuit of our common goal of enhancing food safety.
In closing, we encourage all segments of the produce industry to continue to be attentive to available guidance and to implement applicable best practices.
Michael M. Landa
Center for Food Safety and Applied Nutrition