OMB Meeting Book-October 1, 2015

OMB MEETING MATERIALS - October 1, 2015

36

MEMORANDUM 

Date:  

August 20, 2015 

To: 

AOAC INTERNATIONAL Official Methods Board Working Group on Sole  Source Modification of Official Methods  R. Deborah McKenzie ‐ AOAC Standards Development, AOAC Research  Institute & Staff Liaison, OMB   

From: 

Subject: 

Proposal on Modification of Official Methods 

BACKGROUND:  Prior to 2011, AOAC’s procedures for addressing requests to modify AOAC Official Methods of  Analysis were carried out by the AOAC Methods Committees or AOAC Method Centric Committees  which were under the oversight of the AOAC Official Methods Board.    Both First Action methods and Final Action methods were addressed through this process using  criteria that were both procedural and technical in determining the level of modification of the  method.   Determining the level of modification included editorial, major and minor modifications.   These categories determined the fees assessed as well as the level of technical information and data  required to be submitted to support the modification level.   Within each of those levels, there were  types of modification such as procedural or changes to equipment or supplies needed to run the  method.  Additionally, changes to the method’s applicability, such as adding a matrix or adding an  analyte were also included under the broad category of modification of an OMA.   Approval of modifications also had levels.  Approved modifications of First Action methods can  either restart the two (2) year tracking period or continue the current two (2) year tracking period  from the original approval.  Approved modifications of Final Action methods can cause the method  to revert back to First Action status and start a new two (2) year period of tracking or the method  can maintain its Final Action status.    Method committees tracked changes to these methods via committee reports that were ultimate  approved by the OMB.  With method centric committees, the OMB had to take a more proactive  role in monitoring this process.  When sole source methods were moved to the Research Institute to  administer and Expert Review Panels replaced method committees in the adoption of methods,  there was no discussion on how to address modifications of  Official Methods  that were not  approved via the standard development pathway.  Since then, OMB tried to formulate an approach that incorporated the science and procedure to  address modifications to sole source methods.  However, in 2014 and 2015, the Board of Directors  challenged the OMB to consider an approach to sole source requests to modify OMAs that addresses  changes potential changes in method results, input from stakeholders or method end users, etc…