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WMA 2020.04: Approval of Analytical Methods for Use by Water Mission Area (WMA) Laboratories and WMA-Funded Activities, and Implications for Data Release

Distribution: GS-W All

From: Donald W. Cline - Associate Director for Water

WATER MISSION AREA MEMORANDUM 2020.04 – TECHNICAL POLICY

Subject:  Approval of Analytical Methods for Use by Water Mission Area (WMA) Laboratories and WMA-Funded Activities, and Implications for Data Release

Purpose: Analytical methods used to produce data for USGS studies must be approved so that the resulting data are of known and documented quality, as stated in the Fundamental Science Practices (FSP [link or image removed]). Through this policy, the WMA recognizes two levels of approval: (1) full approval for standard methods, and (2) limited approval for non-standard methods. Method approval is contingent on satisfying requirements for method validation and publication described in this policy memorandum, with detailed procedures for meeting the policy in a related WMA Technical Procedure [link or image removed]. These documents also address the approval of modifications to analytical methods.

Scope: This policy pertains to analytical methods (or modifications of methods) used by laboratories operated in the WMA or in support of WMA-funded activities when those methods are used to produce data delivered to the public or interpreted for USGS studies. This policy replaces Office of Water Quality Technical Memorandum 2004.01 [link or image removed] (OWQ 2004.01) and is effective immediately. Approval of new analytical methods is obtained through satisfying requirements for validation and publication described in this policy. Additional guidance in meeting these requirements is given in a related WMA Technical Procedure [link or image removed]. Limited approval for non-standard methods occurs under the supervisory lines of authority for the laboratory using the method and the internal customer (method user) publishing the data; the method user confirms that the method has been validated and published, which constitutes this limited approval. Full approval for standard methods requires review and approval by the Director of the WMA Laboratory and Analytical Services Division (or designee) to ensure that these methods meet WMA needs. Laboratory activities that do not result in data delivered to the public are excluded from this requirement for WMA method approval (although other requirements may apply). These WMA requirements are an extension of, and do not supersede, the FSP [link or image removed] requirements, including the Quality Management System (QMS) for USGS Laboratories.

 

Definitions

Analytical methods include laboratory processes that ultimately result in recorded data, including standard and non-standard methods (i.e., custom or experimental procedures).

Full approval for standard methods pertains to analytical methods that are widely used for WMA programs or large numbers of projects, thus affecting large numbers of results. A method with full approval from the WMA LASD is expected to perform consistently when used in a “production” capacity across many projects.

Limited approval for non-standard methods pertains to analytical methods operated for a limited set of matrixes or projects. A method with limited approval is expected to have performed satisfactorily for its intended use (unless exceptions are noted), as described in validation documentation and publications.

Modifications include all changes that could potentially substantively change the performance of the method, even if subsequent testing shows that no substantive change in performance occurred (i.e., comparability across the change).

Non-Standard Method is a laboratory method that does not meet the criteria for standard methods; includes a modification of a standard method (used outside the intended scope or context) or a method published in a peer-reviewed outlet (including journal articles) that contains limited validation information pertaining to a particular use or context.

Standard Method is a laboratory method that has been published by international, regional, or national standards-writing bodies, by a reputable technical organization, or in a peer-reviewed publication accompanied by full validation information. Standard methods published after the 2009 President’s Memorandum on Transparency and Open Government [link or image removed] include full validation data documenting a range of performance characteristics.

Background: The previous policy for the approval of water-quality analytical methods contained in OWQ 2004.01 [link or image removed] is outdated. OWQ 2004.01 did not provide pathways for the limited approval of non-standard methods, and it did not anticipate new forms of publication for analytical methods that are currently available. OWQ 2004.01 also stated that changes to [WRD-approved] analytical methods “require documentation in a new publication using the same procedures outlined for the original method approval,” which has been a barrier to the approval of method modifications for many reasons, including ethical concerns about producing a new publication that would likely heavily reproduce an earlier author’s content. This revised policy and the companion technical procedure provides greater flexibility in meeting the requirements for method approval, while also aligning to Bureau-wide policies contained in the Fundamental Science Practices [link or image removed], including the Quality Management System (QMS) for USGS Laboratories.

Policy: This policy restates the FSP [link or image removed] requirement that data used for USGS studies be of known and documented quality, which is the basis for requiring the use of approved analytical methods. The WMA recognizes two levels of approval: (1) full approval for standard methods, and (2) limited approval for non-standard methods, as defined above. Both levels of approval are contingent on ensuring that laboratory methods are validated and published. Guidance in meeting the policy requirements is provided in a related WMA Technical Procedure [link or image removed]. Responsibilities for ensuring the requirements are met are shared between the laboratories that develop (or modify) methods and the customers who use data generated from those methods, within a framework of robust peer review and management oversight.

Established methods that were considered “WRD-approved” or “WMA-approved” under OWQ 2004.01 [link or image removed], including published methods reviewed and approved by the Office of Water Quality and methods published by the U.S. Environmental Protection Agency (USEPA), American Society for Testing and Materials (ASTM), or American Public Health Association (APHA) in Standard Methods (1995 or more recent revisions) are deemed to have met the criteria for full approval for standard methods. Established methods published in journal articles (or similar publications) that have not demonstrated wide applicability of the method across a full range of environmental settings and matrixes might meet the criteria for limited approval for non-standard methods, depending on the scope of the validation and needs of the end user. Methods with no citable reference or no validation data are not approved and should not be used for USGS studies without first obtaining the missing information. It is up to the end users of each laboratory method to evaluate the sufficiency of that method and its documentation for the intended use.

For new standard methods, full approval requires review and approval by the Director of the Laboratory and Analytical Services Division (LASD) or designee, typically prior to Bureau approval of the publication(s). A laboratory operating outside of the LASD may request full approval of an analytical method by providing the complete method description and validation results to the Director (or designee) for WMA LASD review and approval prior to Bureau approval of the method publication (or Center approval, if delegation of that authority has been permitted). Guidance on satisfying the policy requirements is provided in a related WMA Technical Procedure [link or image removed], and laboratories are encouraged to seek technical input or review during the planning and validation stages to ensure that the scope and robustness of the validation are appropriate for routine use as a standard method.

For new non-standard methods, limited approval is accomplished through the supervisory lines of authority for the laboratory using the method and the internal customer publishing the resulting data. Limited approval is accomplished by verifying that (1) the method is appropriate for the intended use and (2) the method and validation data have undergone robust peer review and are published prior to, or concurrently with, the approval and public release of the resulting data. Because the scope of the limited approval is context-specific, a subsequent user of a non-standard method with limited approval would repeat the process of verifying that the method is appropriate for the intended use and that the method and validation data have undergone peer review and are published prior to, or concurrently with, the approval and public release of the resulting data. If the subsequent use differs from the context of the initial validation, or if the method has been modified, additional validation testing could be warranted, following the pathways for method modifications.

For modifications of methods, a description of the modifications and a set of validation data sufficient to document the performance of the modified method must be documented. Although it is still permissible to document a method modification in a new publication (as previously mandated by OWQ 2004.01), this policy permits the use of additional peer-reviewed outlets, such as a method-user’s publication that presents the data, a peer-reviewed Science Base product, a methods section or supplemental information section in a journal article, or an NWQL Technical Memorandum (for NWQL modifications). Customers (end users) would cite the original method and the modification(s) when reporting the resulting data.

For data that are displayed to the public via USGS databases, such as the National Water Information System (NWIS), the analytical method typically is documented through the use of metadata fields. Strategies for the appropriate use of metadata fields for documenting analytical methods in NWIS are presented in a related WMA Technical Procedure [link or image removed].

Additional details on past and current policies relevant to the approval of new analytical methods or modifications of methods for WMA laboratories and WMA-funded activities and suggested workflows for applying this policy are presented in a related WMA Technical Procedure [link or image removed].

References

Office of Water Quality Technical Memorandum 2004.01, Revised Policy for the Approval of U.S. Geological Survey water-Quality Analytical Methods (February 11, 2004), accessed on January 27, 2020, at https://water.usgs.gov/admin/memo/QW/qw04.01.html [link or image removed].

Related Procedures

WMA 2020.05 - Procedure for the Approval of Analytical Methods Used by Water Mission Area (WMA) Laboratories and WMA-Funded Activities, and Implications for Data Release [link or image removed]