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Vibrio parahaemolyticus Risk Assessment – Appendix 1: Chronology of Technical and Scientific Reviews

July 19, 2005

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FDA solicited the advice and opinions of scientific experts, State shellfish specialists, and the public throughout the conduct of thisVibrio parahaemolyticus risk assessment. A summary of the dates, type of review activity, and participants is provided here.

Chronology of Technical and Scientific Reviews of the FDAVibrio parahaemolyticus Risk Assessment
DateActivityReviewers
January 1999Vibrio parahaemolyticus Risk Assessment (VPRA) team assembledFDA
May 7, 1999Federal Register Notice; request for comments and for scientific data and informationPublic
May 27, 1999Public meeting (Chicago, IL)NACMCF; Public;
VPRA team
August 13, 1999Federal Register Notice of public meetingPublic
September 24, 1999Public meeting; request for comments on the risk assessment approach and assumptions (Washington, DC)NACMCF; Public; VPRA team
December 1999Request for scientific review of draft risk assessment documentInteragency Risk Assessment Consortium (RAC) members
December 1999Technical discussion of the draft risk assessment documentRAC members
December 1999Intensive review of modelDr. David Gaylor, FDA/NCTR (National Center for Toxicological Research)
March 31, 2000Internal scientific review of draft documentFDA risk managers
May 29, 2000Technical review of documentSpecial Government Employees (SGEs)
May 29, 2000Review of model and mathematicsGovernment experts and SGEs
July 28, 2000Internal scientific review of draft documentFDA risk managers
January 19, 2001Publication of draft risk assessment document and request for commentsPublic
March 2001Public meeting; presentation of assumptions, approach, and results of the risk assessment and request for comment (66FR 13544)Public
March 20011st extension of public comment period (66 FR13545)Public
May 20012nd extension of public comment period (66 FR 28181)Public
July 2001Close of public comment period 
August 2001 to May 2002Review public comments and plan changes needed to risk assessmentVPRA team members
May 2002Internal scientific review of revised document and modelFDA risk managers and assessors
May 2002- November 2003Additional modelingVPRA team members
December 2003 - January 2004Revision of risk assessmentVPRA team members
February 2004Review of risk assessmentVPRA team members
February 2004Peer review of modelInternal and external experts
April 2004Review of risk assessmentFDA risk managers
May 2004Editing of risk assessment documentVPRA team members
August 2004Review of risk assessmentFDA risk managers
October 2004Begin developing analysis to compare model with epidemiological dataCDC and VPRA team
January 2005Begin preparation of reportVPRA team
May 2005Review of risk assessmentFDA risk managers
June 2005Began clearance/ approval processFDA

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