TEXAS DEPARTMENT OF STATE HEALTH SERVICES (DSHS) DIVISION FOR REGULATORY SERVICES ENVIRONMENTAL AND CONSUMER SAFETY SECTION FDA REQUEST FOR PROPOSAL PROJECT SUMMARY/ABSTRACT The primary objective of this grant is to improve the speed and effectiveness of DSHS recalls process and to work in tandem with FDA on mandatory, voluntary, inter-state and intra-state recalls. The following activities are planned in order to meet the objectives detailed in RFA-FD-12-026 Building the Capacity of Food Safety Entities to Protect Public Health in Response to a Notification under section 1008 of the Federal Food, Drug and Cosmetic Act or a Recall of Foods (U18). 1. Fund one Department of State Health Services (DSHS) Full Time Equivalent (FTE);a Sanitarian III position. This employee will act as Program Director of this grant. 2. Purchase supplies and equipment related to the Recall position. Prepare for approximately 20 recalls per year. 3. Review current Recall Procedures and model DSHS procedures to FDA Recall Procedures (Chapter 7 of Regulatory Procedures Manual). 4. Develop automated system to track recalls and provide details for each recall. Collaborate with FDA Dallas District Office (DALDO) to design this data in tandem, or similar, to their Recall Enterprise System (RES). 5. Familiarize new employee to the Texas Rapid Response Team (TRRT), which is partnered with DSHS, FDA Dallas District Office (DALDO) and the Office of the Texas State Chemist (OTSC). Include new Recall employee in the TRRT Incident Command System (ICS) training for all TRRT members. Incident Specific training to be scheduled in winter of 2013. 6. In order to develop metrics related to increased efficiency and effectiveness of examinations, inspections and investigations and other food safety activities, the Recall PD will work to review and eliminate gaps in present procedures and will implement needed improvement plans. 7. In September of 2010 a Process Improvement Team (PIT) committee was formed to develop a viable Risk Matrix Tool to assign risk factors to DSHS inventory. This has been an ongoing project, as the ratings change based on field inspection results. A primary duty of the PD of this Recall grant is to continue to fine tune this Risk Matrix. This would entail following repeat offenders and tracing recall histories.
TEXAS DEPARTMENT OF STATE HEALTH SERVICES (DSHS) DIVISION FOR REGULATORY SERVICES ENVIRONMENTAL AND CONSUMER SAFETY SECTION FDA REQUEST FOR PROPOSAL NARRATIVE The primary objective of this grant is to improve the speed and effectiveness of DSHS recalls process and to work in tandem with FDA on mandatory, voluntary, inter-state and intra-state recalls. The consequence of these efforts will impact on public health in the following areas: Improving the speed of recalls will remove products for public consumption and will result in fewer illnesses in a food-borne illness outbreak; Improving the process by effectiveness checks on recalls will provide lessons learned in the recall effort and underscore those areas that need to be improved upon in order to have a speedy and effective recall effort; Development of metrics will enhance the process and set the goals for most efficient and expedite process available to protect public health from contaminated products;and Improvement of the Risk Matrix will protect public health by increasing inspections/investigations/monitoring of high risk entities, leading to a decrease in food-borne illness outbreaks overall.