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MEMORANDUM
Date:
August 20, 2015
To:
AOAC INTERNATIONAL Official Methods Board Working Group on Sole
Source Modification of Official Methods
From:
R. Deborah McKenzie ‐ AOAC Standards Development, AOAC Research
Institute & Staff Liaison, OMB
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…
OMB MEETING MATERIALS - October 1, 2015
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