To: Joni Arends
From: Arjun Makhijani
Subject: Some quality assurance issues regarding input data for unmonitored sources dose estimation
Date: September 1, 2002
This memorandum follows up on one aspect of my July 11, 2002 memorandum regarding unmonitored sources: quality assurance relating to input data. Justin Mohler is aware of the facts mentioned here. This memorandum provides IEERšs view of the issues that need to be addressed by the ITAT in this regard.
My understanding is that MAQ does not at present make sure that the data provided by users have gone through a QA process. MAQ does not require the maintenance of QA records for this data and does not maintain any records, formal or informal, of any QA to which the data might have been subjected by the user.
I had mentioned some items that point to the lack of user data QA in my July 11, 2002 memorandum. A further example came up during the August 22, 2002 visit to LANL at TA-35-213 Room F-11 and the associated discussion held with Sue Terp of MAQ. The tritium content of tiles was first reported as 400 mCi from memory over the phone by Bob Reiswig who works in Room F-11. He then looked up the shipping manifest from Princeton, having had a hunch that he might have made a mistake. He found that the figure in the manifest was 40 mCi. Mr. Reiswig then made a new phone call to notify MAQ of the change and reportedly left a message on the answering machine explaining the error and providing the new figure. This new figure of 40 mCi was also accepted as correct by MAQ.
Scientific aspects of quality assurance
IEER strongly recommends that ITAT should examine the scientific and compliance aspects of the lack of a systematic quality assurance component for the input data for unmonitored sources. As regards the scientific aspect of the matter, the lack of a procedure at the user's end for ensuring that the data provided to MAQ are correct, is troubling. The MAQ staff do check the calculations when they are provided by the user and often ask for them, but there is no set process for determining the accuracy of the data that go into the calculations. The deficiency is compounded in those cases where there is a lack of systematic facility review of the actual changes in the inventories of the radionuclides in the possession of users. In sum, the ITAT needs to assess the scientific adequacy or lack thereof of the process by which the input data are generated for unmonitored source dose estimations. How can the validity of the results be assured if the quality of the input data is not systematically assured?
Legal aspects of quality assurance
IEER also strongly recommends that the ITAT also examine carefully the compliance aspect of this situation, as recommended in my July 11, 2002 memo. Let me elaborate here. Subpart H explicitly requires quality assurance for all stack measurements as well as all environmental measurements. It also requires "periodic confirmatory measurements" to be made for those sources of emissions considered too low for continuous stack sampling (40 CFR 61.93 (b)(4)(i)). These periodic confirmatory measurements are subject to the same rigorous quality assurance requirements as the continuously sampled stacks.
The EPA has allowed LANL to employ emissions estimates based on user surveys and dispersion modeling as a substitute for periodic confirmatory measurements. In other words, LANL makes no periodic confirmatory measurements to ensure that emissions from unmonitored sources are low, but relies entirely upon the user-supplied information as the basis for dose estimation and compliance assessment for unmonitored sources. Therefore ensuring that quality of the input data is of paramount importance.
The ITAT should carefully evaluate the whether a quality assurance requirement for user supplied data is implicit in Subpart H as it is being implemented by LANL that is without confirmatory measurements. The ITAT should then evaluate whether LANL is in compliance with Subpart H in this regard.
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