About FDA
Promote Safe Production of Molluscan Shellfish for Human Consumption: Vibrio Forecasting and Assistance
Description: The Office of Food Safety, working collaboratively with shellfish specialists in ORA, is charged with promoting the safe production of molluscan shellfish for human consumption. To do so, the FDA participates in the Interstate Shellfish Sanitation Conference (ISSC), a voluntary cooperative body of federal, state and industry representatives that develops national guidelines for the regulation of shellfish production. With FDA concurrence, guidelines developed through the ISSC are adopted as standards for the National Shellfish Sanitation Program (NSSP), the federal/state cooperative program recognized by the FDA for the sanitary control of shellfish distributed in interstate commerce.
Accomplishment: All objectives on Vibrio spp. have been completed. Two of the objectives are ongoing: 1) quarterly updates on research to develop Vibrio forecasting tools to ensure alignment of research with policy needs and 2) quarterly meetings of the Vibrio Assistance Review Board (VARB) with dissemination of final action summary to the FDA National Shellfish Team and ISSC within five business days. FDA continues to work with NOAA and external stakeholders on forecasting tools for Vibrio, primarily V. parahaemolyticus. FDA�s VARB continues to review, prioritize, and track submissions to FDA from State Shellfish Control Authorities (SSCA) and industry requesting Vibrio spp. related research and technical assistance. To date, the VARB has supported joint FDA-SSCA projects, with industry participation in many cases, that resulted in the generation of data that was used to inform control practices for V. parahaemolyticus. For example, baseline levels of V.p. have been established for states to aid in (1) the determination of whether to allow the summer harvest of shellfish (South Carolina) and (2) the understanding of V.p. levels in a location associated with illnesses (Massachusetts). The most recent joint FDA-SSCA project undertaken evaluates risk mitigation strategies (e.g., submerging) associated with typical aquaculture practices that could otherwise promote Vibrio spp. growth (Alabama).
Briefing Status: ON TRACK
Prior Briefing Status: On TRACK
Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
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A. Vibrio Forecasting Research |
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i. Provide quarterly updates on progress of research to develop Vibrio forecasting tools to ensure alignment of research with policy needs. |
Each Quarter |
On Track | |
ii. Form a workgroup, including FDA, NOAA, and other external partners, to determine research needs and priorities for the development of ecological forecasting (modeling) tools for Vibrio. |
12/31/2015 |
Completed | 10/16/2015 |
iii. Co-lead, with NOAA, a special session on ecological forecasting of marine microbes at the 2016 Ocean Sciences Meeting to identify best available science and research advances in the field of ecological forecasting. |
3/31/2016 |
Completed | 2/26/2016 |
iv. Define research needs and priorities for Vibrio ecological forecasting tools. |
3/31/2016 |
Completed | 3/15/2016 |
v. Develop two regional ecological forecasting experimental models for Vibrio doubling-time (Puget Sound, WA and Long Island Sound). |
12/31/2016 |
Completed | 4/25/2016 |
vi. Articulate the FDA position on the public health benefit of developing forecasting tools by formalizing a policy statement regarding FDA and NOAA development of forecasting tools. |
3/31/2016 |
Completed | 12/31/2016 |
vii. Obtain a letter of support for development of forecasting tools from the Interstate Shellfish Sanitation Conference (ISSC). |
12/31/2015 |
Completed | 6/23/2015 |
B. Vibrio Assistance Review Board (VARB) |
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i. Establish quarterly meetings of the vibrio assistance review board (VARB), with dissemination of final action summary to FDA National Shellfish Team and ISSC within five business days. |
Each Quarter |
On Track | |
ii. Create the Vibrio Assistance Review Board (VARB) and standard operating procedures for receiving, reviewing, prioritizing, granting, and tracking external requests for Vibrio research and technical assistance. |
10/31/2015 |
Completed | 1/1/2015 |
iii. Complete the review of VARB requests for Vibrio research and technical assistance for 2015, create the final summary of actions, and disseminate the decisions to the FDA National Shellfish Team and the ISSC. |
12/31/2015 |
Completed | 6/6/2016 |
iv. Report on the results of all supported VARB projects in 2015. |
12/31/2016 |
Completed | 12/31/2016 |
Key Projects Legend
Milestone Status | Definition |
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Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |