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Implementation of the DEP Compendium of Analytical Methods (CAM) February 24, 2003
Dear Licensed Site Professional (LSPs) and Interested Parties:
As many of you know, for the last three years, MADEP has been engaged in a series of coordinated efforts to improve the quality and consistency of analytical data submissions by parties conducting response actions under the Massachusetts Contingency Plan (MCP). These initiatives were catalyzed by a widespread recognition among LSPs, agency staff, and laboratory personnel of a need to "raise the bar" and "level the playing field" in matters of this nature.
I am pleased to announce that the Department is now in the process of finalizing a series of guidance and policy documents on this important subject. I would encourage you to become familiar with the material described below and begin planning for its implementation in the coming months.
Background
In June of 2000, a Data Enhancement Workgroup was established to assist and advise the Department in these efforts. Thanks in large part to the dedication of this workgroup - comprised of analytical chemists, LSPs, data validators, and other parties - considerable progress has been made in this regard, as summarized below:
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January 2001: The first of a series of draft "MCP Analytical Methods" was placed on the MADEP web site.
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July 2001: A discrete "Data Quality" section was added to the MADEP web site, to facilitate the posting and distribution of a growing series of draft methods, discussion documents, and related materials.
- May 2002: In conjunction with the LSPA, a comprehensive training program was undertaken to provide LSPs and others with a basic understanding of analytical and quality control concepts and procedures, and information on the Department's data quality initiatives.
Recently, the following final draft documents were posted on our web site:
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Overview of the MCP Analytical Data Enhancement Process (January 27, 2003)
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Sampling, Data Evaluation, and Reporting (January 27, 2003)
These documents, elements of the MADEP Compendium of Analytical Methods (CAM), serve two purposes. First, they provide general information and guidelines on analytical and data quality issues, and on the general MCP performance standards at 40.0017 and 40.0191. In addition, an elective option is detailed which will enable parties to achieve a status of "Presumptive Certainty" of data acceptance by agency reviewers.
Presumptive Certainty
In order to achieve Presumptive Certainty, parties must:
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Use the "MCP Analytical Methods" detailed in the CAM;
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Report concentration data for all compounds/elements on the method-specific analyte list;
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Adopt the Tentatively Identified Compound (TIC) reporting requirements specified for the individual testing procedures in the CAM;
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Comply with the applicable QC requirements prescribed for the individual testing procedures in the CAM;
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Collect and analyze field samples and field QC samples in the manner prescribed in the CAM;
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Provide acceptable sample custody documentation; and
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Adopt the reporting contents, formats, and certifications specified in the CAM.
In achieving the status of Presumptive Certainty, parties will be assured that an analytical data set:
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satisfies the broad QA/QC requirements of 310 CMR 40.0017 and 40.0191 regarding the scientific defensibility, precision, accuracy, and reporting of analytical data;
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may be used in a data usability assessment, and, if in compliance with all MCP Analytical Method standards, laboratory QC requirements, and field QC recommended limits and action levels, will be considered usable data for site characterization decisions made pursuant to the Massachusetts Contingency Plan; and;
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may be used in a data representativeness assessment.
MADEP will accept comments on these final draft documents until April 1, 2003. By May 1, 2003, all documents will be issued in final form. On August 1, 2003, these documents will become effective policies, which, pursuant to 40.0191, must be considered by all parties conducting response actions at sites regulated by the MCP.
Data Quality Expectations
The Compendium of Analytical Methods, when finalized and implemented, will provide the regulated community with the means and tools to obtain and provide analytical data of a known and demonstrated level of quality, sufficient to support response action decisions at contaminated sites, and satisfy the regulatory requirements of the MCP at 40.0017 and 40.0191. All MCP analytical data submissions made to the Department for samples collected on or after August 1, 2003 will be expected to contain the level of support and documentation needed to satisfy these regulatory requirements, using the tools and guidelines contained in the Compendium of Analytical Methods, or other appropriate and scientifically sound procedures and techniques.
I would urge you to start planning today for these coming events. At a minimum, you should communicate with your analytical service provider(s) now to ensure that they are familiar with these efforts and these final draft MADEP publications. You should further consider if and/or when you would avail yourself of the Presumptive Certainty option provided in the Compendium of Analytical Methods. If you elect not to use the Presumptive Certainty option, you must be prepared to obtain and document data in a manner compliant with MCP data quality and response action requirements.
Note that it is the persons making submissions under the MCP - not laboratories - that are responsible for the quality of information provided. For that reason, it is necessary that such parties be proactive in ensuring that analytical data used to support response action decisions and opinions are of a known and sufficient level of quality. The Department recognizes the burden this places on LSPs and others, which is why we have developed these guidelines, and why we have provided a Presumptive Certainty option.
In closing, I would like to thank you for your interest, patience, and comments during the development of these policies, and encourage your continued participation in the finalization and implementation of this effort. If you have any questions in this matter, please contact Donald Muldoon of my staff at 617/292-5785 or Donald.Muldoon@state.ma.us.
Sincerely,
Deirdre C. Menoyo Assistant Commissioner Bureau of Waste Site Cleanup
c.c. Arleen O'Donnell, Deputy Commissioner, Policy and Planning
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