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Methods Development & Approval Process
Highlights
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The Office of Resource Conservation and Recovery's (ORCR) manual of EPA-approved analytical methods, Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (SW-846), ensures the availability of established, validated methods for the measurements and monitoring needed for the RCRA program. All of the methods published in SW-846 have been approved by EPA. While EPA cannot evaluate every applicable method, the Agency does conduct scientific evaluations of new methods that:
- offer cost-effective alternatives or significant improvements in data quality, and
- are expected to find broad application in environmental monitoring. These methods are then published in SW-846.
- Part One explains how to obtain assistance from the Methods Team during the method development and evaluation process, and
- Part Two explains the actual process of applying for inclusion of a new measurement or monitoring method in SW-846.
Part One: Technical Assistance
The Methods Team supports the development of new measurement technologies by:
- Assisting developers in designing proof of concept studies.
- Hosting forums to facilitate the interchange of ideas between the user and developer communities to stimulate development of new techniques.
- Assisting developers in designing evaluation studies prior to submitting an application for new method approval.
Part Two: The Application Process
To have a method published in SW-846, applicants must follow certain
procedures established by the Methods Team. Adherence to these requirements
can help speed the approval process.
When a method project is completed, the developer should assemble a package
of documents describing the project and submit it to the Agency for review
and evaluation. The documentation package should include:
- Hard and electronic copies of the method. See SW-846 Method Style Guide - June 25, 2012 (PDF) (47 pp, 393 K) the supporting document describing the rationale behind the method development effort and how the key elements described in the document were addressed.
- A data package containing both the raw and summarized single-laboratory and multilaboratory data.
- Any diagrams of specific equipment and instrument results (e.g., chromatogram or spectra) pertinent to the demonstration of appropriate performance for the intended application method.
- Copies of any references listed in the method.
- Any method-specific quality control criteria.
The above material should be submitted in hard copy and on disk (preferably
in MS Word 2003) to the following address:
U.S. Environmental Protection Agency
Office of Resource Conservation and Recovery (ORCR)
1200 Pennsylvania Ave. NW (5307P)
Washington, DC 20460
Method Evaluation Criteria
EPA uses the following criteria when evaluating a new method:
- Is there a need for the intended scope and application of the method?
- Will the submitted method generate data consistent with the intended
scope and application of the method?
- Have appropriate quality control procedures been developed for this procedure?
Resources
- Guidance for Methods Development and Methods Validation for the RCRA Program (PDF) (32 pp, 105K)
- Guidance for Submittal of New Immunoassay Methods (PDF) (14 pp, 45K)
- List of Validated Immunoassay Test Kits (PDF) (1 pg, 30K)
- Guidelines for Revalidation of Exisiting Immunoassay Based Analytical Products (PDF) (5 pp, 17K)
