TECHNICAL COMMITTEE REPORTS

Committee on Statistics

PAUL WEHLING, CHAIR

General Mills, Inc., 330 University Ave SE, Minneapolis,

MN 55414

FOSTER D. MCCLURE, PAST CHAIR

U.S. Food and Drug Administration (retired), Frederick, MD

QIAN F. GRAVES, SECRETARY

U.S. Food and Drug Administration, Center for Food Safety

and Applied Nutrition, HFS-012, 5100 Paint Branch Pkwy,

College Park, MD 20740-3835

ROBERT A. LABUDDE

Least Cost Formulations Ltd, 824 Timberlake Dr, Virginia

Beach, VA 23464-3239

JUNG K. LEE

U.S. Food and Drug Administration, HFS-012, 5100 Paint

Branch Pkwy, College Park, MD 20740-3835

ZHICHAO LIN

U.S. Food and Drug Administration, 109 Holton St,

Winchester, MA 01890

JOHN G. PHILLIPS

U.S. Department of Agriculture, Agricultural Research

Service, Eastern Regional Research Ctr, 600 E. Mermaid

Ln, Wyndmoor, PA 19038-8551

STEPHEN SHERKEN

U.S. Food and Drug Administration (retired), Kensington,

MD 20895

Committee Activities

The Statistics Committee reviewers performed 25 reviews

on Official Methods of Analysis (OMA) submissions for

AOAC INTERNATIONAL this year. Of those, 14 were

original manuscripts and nine were revised manuscript reviews.

The Statistics Committee revised Appendix J and

Appendix K of the OMA Program Manual to conform to the

changes in Appendixes Q and R, which were made by the

Official Methods Board (OMB) previously.

The Statistics Review Training Outline Working Group

(Paul Wehling, Robert LaBudde, John Phillips, and Qian

Graves) met several times by teleconference and discussed

ways to train statistical reviewers to perform reviews on

collaborative protocols and manuscripts. The group is

working on training presentations for future Statistics

Committee members to share best practices.

LaBudde and Wehling have revised a proposal for

revisions of Appendix X of the OMA Program Manual which

they helped develop in July 2007. The proposed revisions to

the guidelines for validation of quantitative and qualitative

microbiological methods were intended primarily to clarify

the statistical procedures used in qualitative microbiological

methods. Wehling and LaBudde have contributed to the

development of guidelines for Biological Threat Agents. The

first guideline document was titled AOAC INTERNATIONAL

Methods Committee Guidelines for Validation of Bacterial

Threat Agent Methods and/or Procedures. Most of the

statistical treatments in this document were gleaned from the

proposed Appendix X revisions mentioned above.

Publications

McClure, F.D., & Lee, J.K. (2009) J. AOACInt. 92, 1593–1601

McClure, F.D., & Lee, J.K. (2009) J. AOAC Int. 92, 320–328

McClure, F.D., & Lee, J.K., (2008) J. AOAC Int. 91, 660–669

Nelsen, T.C., & Wehling, P. (2008) Cereal Foods World,

53, 285–288

Committee Organization

In order to better serve the needs of the Association as the

OMA process changes, committee members have decided to

reorganize the committee. For any standing Methods

Committees, the committee will still assign statistical advisors

to consult on study designs and perform OMA program

reviews. For smaller adhoc committees, the committee will

draw from two pools of advisors to be organized around the

type of method statistics used, either quantitative or

qualitative. The committee will assign new committee

advisors from the two pools as needed.

In addition, the committee will have a theoretical

“Methodology” subgroup that will discuss and debate current

issues in method validation and work to keep the guidelines

for method validation at the leading edge of statistical

methodology.

Quantitative statistics.—Phillips, Graves, LaBudde, and Zichao.

Qualitative statistics.—LaBudde, Wehling, Sherken, and

Zichao.

Methodology.—Graves, Lee, McClure, Phillips, Sherken,

and Wehling.

Current standing Methods Committee assignments are as

follows:

Committee on Pesticides and Disinfectant Formulations:

Jung Lee

Committee on Natural Toxins and Food Allergens:

Paul Wehling

Committee on Microbiology: Robert LaBudde and

Paul Wehling

Committee on Biological Threat Agents: Robert LaBudde

Committee on Antimicrobial Efficacy Testing:

Robert LaBudde

38B METHODS COMMITTEE REPORTS: JOURNAL OF AOAC INTERNATIONAL VOL. 93, NO. 1, 2010