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July 19, 2005
FDA solicited the advice and opinions of scientific experts, State shellfish specialists, and the public throughout the conduct of this Vibrio parahaemolyticus risk assessment. A summary of the dates, type of review activity, and participants is provided here.
| Date | Activity | Reviewers |
|---|---|---|
| January 1999 | Vibrio parahaemolyticus Risk Assessment (VPRA) team assembled | FDA |
| May 7, 1999 | Federal Register Notice; request for comments and for scientific data and information | Public |
| May 27, 1999 | Public meeting (Chicago, IL) |
NACMCF; Public; VPRA team |
| August 13, 1999 | Federal Register Notice of public meeting | Public |
| September 24, 1999 | Public meeting; request for comments on the risk assessment approach and assumptions (Washington, DC) | NACMCF; Public; VPRA team |
| December 1999 | Request for scientific review of draft risk assessment document | Interagency Risk Assessment Consortium (RAC) members |
| December 1999 | Technical discussion of the draft risk assessment document | RAC members |
| December 1999 | Intensive review of model | Dr. David Gaylor, FDA/NCTR (National Center for Toxicological Research) |
| March 31, 2000 | Internal scientific review of draft document | FDA risk managers |
| May 29, 2000 | Technical review of document | Special Government Employees (SGEs) |
| May 29, 2000 | Review of model and mathematics | Government experts and SGEs |
| July 28, 2000 | Internal scientific review of draft document | FDA risk managers |
| January 19, 2001 | Publication of draft risk assessment document and request for comments | Public |
| March 2001 | Public meeting; presentation of assumptions, approach, and results of the risk assessment and request for comment (66FR 13544) | Public |
| March 2001 | 1st extension of public comment period (66 FR13545) | Public |
| May 2001 | 2nd extension of public comment period (66 FR 28181) | Public |
| July 2001 | Close of public comment period | |
| August 2001 to May 2002 | Review public comments and plan changes needed to risk assessment | VPRA team members |
| May 2002 | Internal scientific review of revised document and model | FDA risk managers and assessors |
| May 2002- November 2003 | Additional modeling | VPRA team members |
| December 2003 - January 2004 | Revision of risk assessment | VPRA team members |
| February 2004 | Review of risk assessment | VPRA team members |
| February 2004 | Peer review of model | Internal and external experts |
| April 2004 | Review of risk assessment | FDA risk managers |
| May 2004 | Editing of risk assessment document | VPRA team members |
| August 2004 | Review of risk assessment | FDA risk managers |
| October 2004 | Begin developing analysis to compare model with epidemiological data | CDC and VPRA team |
| January 2005 | Begin preparation of report | VPRA team |
| May 2005 | Review of risk assessment | FDA risk managers |
| June 2005 | Began clearance/ approval process | FDA |
