OMB Meeting Book (June 25-26, 2015)

b. OMB Committees and Working Groups: McKenzie discussed with the OMB an opportunity for them to form more permanent working groups for regularly scheduled tasks as a way to provide additional leadership opportunities for members within the OMB. ACTION: No action taken.

IV.

OMA METHOD MODIFICATIONS a.

Modification of OMA methods that have no Expert Review Panels: i.

OMB considered addressing several points: Do we have the experts (on the OMB) needed for a thorough review? What is the impact (of the proposed modification) on Stakeholders? What is the current status of the methods (First Action, Final Action, how long?)

ii.

iii.

iv.

Should a new method number be considered?

v.

What type of modification is being proposed? For example, does the modification:

4.1..5.1 Increase the cost of testing? 4.1..5.2 Require new equipment? 4.1..5.3 Require new chemicals? 4.1..5.4 Change the final result? 4.1..5.5 Other, Etc. Is the quality of science maintained? Is the supporting data sufficient?

vi.

vii.

viii.

Are there any First to Final Action requirements?

b.

Proposed Modification Approval Process (for methods without ERPs) ƒ Application Process i. Modification Application is submitted

4.2..1.1 The OMB has recommended that the application be modified to include a section that addresses potential impact on stakeholders The method information and request for the proposed modification is posted for a 30 day comment period The CSO reviews the submission and any comments and recommends an appropriate response to the applicant. This includes any work that may be needed to support the modification of the method. The method modification proposal, comments, and the CSO recommendations are forwarded to the OMB for review. The method modification application, CSO recommendation and any supporting documentation is sent to the OMB. 4.2..5.1 All OMB members will review the method modification package. 4.2..5.2 The OMB chair typically appoints at least 2 OMB members to lead the discussion of the modification. These members will have experience with the method/technology and will perform an in Ͳ depth review. 4.2..5.3 The OMB may also decide to consult with additional SMEs Discussion of the method modification is added to the next OMB teleconference or meeting. Based on the review and discussion, the OMB comes to a consensus:

ii.

iii.

iv.

v.

vi.

vii.