Quimico

Method Validation of U.S. Environmental Protection Agency

Microbiological Methods of Analysis


Prepared for:

The EPA Forum on Environmental Measurements (FEM)
Prepared by:

The FEM Microbiology Action Team
FEM Document Number 2009-01

October 7, 2009


Contributors:

Sandhya Parshionikar, PhD

Richard A. Haugland, PhD

Orin Shanks, PhD

Technical Support CenterOffice of Groundwater and Drinking
Water
Cincinnati, Ohio

National Exposure Research Laboratory
Office of Research and Development
Cincinnati, OH

National Risk Management
Research Laboratory
Cincinnati, OH

Margo E. Hunt, PhD

Michele Cottrill

Ann Grimm, PhD

Quality Staff
Office of Environmental Information
Washington, DC

OPPTS/OPP/BEAD/Microbiology
Laboratory Branch
Ft.Meade, MD

National Exposure Research
Laboratory
Cincinnati, OH

Fred Genthner, PhD

Stephanie Harris, D.V.M.

Robin K. Oshiro, PhD

National Health & Environmental
Effects Research Laboratory
Gulf Breeze, FL

US EPA Region 10 Laboratory
Manchester, WA

Office of Science and
Technology
Washington, DC

Andrew Lincoff

Stacy Pfaller, PhD

Mano Sivaganesan, PhD

US EPARegion 9 Laboratory
Richmond, CA

National Exposure Research Laboratory
Cincinnati, OH

National Risk Management
Research Laboratory
Cincinnati, OH

Disclaimer
This document contains direction developed solely to provide internal guidance to U.S.
Environmental Protection Agency (EPA) personnel. EPA retains the discretion to adopt
approaches that differ from this guidance on acase-by-case basis. The guidance set forth in this
document does not create any rights, substantive or procedural, enforceable at law by a party to
litigation with EPA or the United States. The use of mandatory language such as “must” and
“require” in this guidance document reflects sound scientific practice and should not be
construed to create any legal rights or requirements. The use ofnon-mandatory language such as
“may,” “can,” or “should” in this guidance does not connote a requirement but does indicate
EPA’s strongly preferred approach for validating and peer reviewing EPA methods prior to
publication for general use.
References within this document to any specific commercial product, process, or service
by trade name, trademark, manufacturer, or otherwise does not necessarilyimply its endorsement
or recommendation by EPA. Neither EPA nor any of its employees, makes any warranty,
expressed or implied, nor assumes any legal liability of responsibility for any third party’s use, or
the results of such use, of any information, apparatus, product, or process disclosed in this
manual, nor represents that its use by such third party would not infringe on privately ownedrights.

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Foreword
The U.S. EPA Science Policy Council (SPC) established the Forum on Environmental
Measurements (FEM) in April 2003. The FEM is a standing committee of senior EPA managers
who provide EPA and the public with a focus for addressing measurement and methods issues
with multiprogram impact. Action teams are commissioned by the FEM to address specific
issues. The MethodValidation Team was formed in October 2003 and tasked with developing
Agency-wide, internal guidance for validating and peer reviewing EPA methods prior to
publication for general use. This document contains guidance for microbiological methods of
analysis.

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Acknowledgements
The authors would like to thank the following reviewers for their contributions to this
document.
Reviewers
MarkBorchardt, PhD

Marshfield Clinic Research Foundation, Wisconsin

George Di Giovanni, PhD
Texas A&M Agricultural Research and Extension Center, Texas
Yildiz Chambers

Computer Science Corporation

Ronald Landy, PhD
Region 3, Environmental Sciences Center, USEPA
Nicholas Ashbolt, PhD

Office of Research and Development, USEPA

Carrie Miller

Office of Groundwater and...