Adaptation of the Listeria Monocytogenes Risk assessment to a 2-Dimensional Model for the Development of Acceptable Level of Protection, Food Safety Objective, and Performance Objectives

The United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) intends to award on a sole source basis a Firm Fixed Price Purchase Order to Virginia Tech University, Dept. of Civil and Environmental Engineering, 409 Durham Hall, Blacksburg, VA 24061. This proposed action is being procured on a n unrestricted basis. This requirement is for the adaptation of the Listeria Monocytogenes risk assessment to a 2 dimensional model for the development of acceptable level of protection (ALOP), food safety objective (FSO), and performance objectives (PO). The following activities will be conducted: 1) Contractor will determine what changes are need to upgrade the 2003 FSIS Risk Assessment for Listeria monocytogenes in Deli Meats to a 2-dimensional probabilistic risk assessment model (typically a Monte Carlo assessment) sufficient to be used to estimate ALOP, FSO, and POs for Listeria monocytogenes. The upgrade requires that the model accounts for both variability (e.g., between food servings) and uncertainty. The Contractor will then alter the existing risk assessment and document those changes and the effect to the output of the model in a written report; 2) Contractor will recalibrate the contamination event parameters in the 2003 FSIS Risk Assessment to match the most current retail data available (Draughton, 2006); 3) Contractor will extend the 2003 FSIS Risk Assessment model to estimate Listeria monocytogenes distribution at time of consumption using the data and approach of the 2003 FDA-FSIS Relative Risk Ranking Model; 4) In discussion with FSIS, contractor will select and program a dose-response relationship suitable for Listeria monocytogenes in the selected RTE food type. The 2003 FDA-FSIS model contains a dose-response relationship, but the approach used requires significant calibration; 5) Using the 2003 FSIS Risk Assessment for Listeria monocytogenes in Deli Meats model, the contractor will use the method developed for C. perfringens to estimate ALOP, FSO and PO within a specific RTE product (assumed to be deli meat) according to the general specifications of the Codex Committee on Food Hygiene at the 95% and 99% confidence levels. Alternative methods of estimating these metrics can be employed; however, changes to the previous approach shall be justified; 6) The contractor will develop a sampling plan for verifying compliance with the POs developed by the contractor and evaluate it at the 95% and 99% confidence levels; and 7) The contractor will develop a report describing the methodology, changes to the previous methodology, the technical aspects, lessons learned, and the results of this model including sensitivity and uncertainty analysis for the distribution of the expected number of illnesses, hospitalizations, and deaths due to consumption of contaminated deli meats with Listeria monocytogenes. In addition, the contractor will also describe the current state of knowledge of ALOP, FSO and PO approaches. Virginia Polytechnic Institute and State University is the author of the work which is to be expanded in this current contract and is therefore uniquely qualified to continue the evolution of this project. Virginia Tech was involved with the collection and analysis of data, construction and coding of the original Listeria monocytogenes risk assessment model, and the original drafting and writing of the main report. They fully understand the construction and history behind the report and model, and has a working knowledge of all the inputs and relationships represented within the model. They are therefore uniquely qualified to change the original model coding by developing and incorporating a new 2-D model component, new data, and changing the model to estimate ALOP, FSO and POs. Given this, they are also uniquely qualified to understand, manage, and if needed troubleshoot how such changes will affect the Listeria monocytogenes risk assessment. This is not a request for quote. No solicitation is available for this requirement. Interested concerns may submit a capability statement within 15 days after the posted date of this notice. All timely responses will be considered; however, a determination by the Government not to complete this requirement based upon the responses received is solely within the discretion of the Government. Responses should be addressed to the attention of the Contracting Officer referencing number FSIS-177516. Responses may be submitted via email to Crandall.Watson@fsis.usda.gov or by fax at (301) 504-4276. It is anticipated that award will be made by August 29, 2008.