Review of ATSDR's Great Lakes Report Drafts Letter Report (2008) / Chapter Skim
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Pages 7-32
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From page 7... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS (LETTER REPORT) ORGANIZATION OF THIS LETTER REPORT A cover letter to Dr.
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From page 8... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS BACKGROUND ON ATSDR DRAFTS EVALUATED In 1972, the US-Canada Great Lakes Water Quality Agreement (GLWQA, 1972; amended 1978) committed the United States and Canada to restoring and maintaining the chemical, physical, and biological integrity of the Great Lakes Basin Ecosystem.
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From page 9... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS designated as critical by the IJC.5 That draft was reviewed internally by ATSDR, and by the IJC, the Environmental Protection Agency (EPA) , four external reviewers, and state public-health officials.
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REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS provides recommendations for developing clear statements of purpose and a sufficient rationale for the selection of data sources. Those steps are necessary to conduct research of good scientific quality.
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From page 11... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS Purpose of the Report Drafts There is no well-defined, consistent statement of the objectives or purpose of the drafts. The apparent purpose also changed from one draft to another.
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From page 12... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS with the AOCs.8 Even when the geographic region covered by a PHA is the same as an AOC, the information included in the PHA might not capture all potential environmental concerns or potential health effects in the AOC. A PHA could identify potential or observed direct effects of contaminants on human populations (through direct or indirect exposures)
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From page 13... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS inclusion or exclusion, would not only guide such decisions in the study, but add to the value of the draft as a compendium. The rationale for inclusion of some hazardous-waste sites and exclusion of others is not presented in the 2007 draft, and although it is better explained in the 2008 draft, some data modifications made between the 2007 and 2008 drafts raise questions about the methods used in both drafts (e.g., for selecting hazardous-waste sites)
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From page 14... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS draft. The committee had concerns about the lack of delineated criteria for choosing the datasets, the relevance of the contaminant data to exposures (i.e., the lack of or uncertainty regarding completed exposure pathways, and lack of exposure-relevant environmental contaminant concentrations)
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From page 15... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS Completed Exposure Pathways Despite criticisms by reviewers of the 2004 draft, the 2007 and 2008 drafts contain no general framework that would link environmental releases with resulting environmental concentrations, and with human exposures leading to risk of disease. In the 2008 draft ATSDR provides more clarity about the requirements for a completed exposure pathway.11 Under most circumstances, however, the overall implication of those requirements is the difficulty in ruling out or in the possibility of completed exposure pathways once a chemical release has occurred.
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From page 16... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS greater effect than releases within an AOC county (for example, if they are upwind or in the watershed of the AOC, and the released materials can be transported over sufficient distances)
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From page 17... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS which omits health effects. A suitable, clearly delineated approach to the task would have highlighted the problem.
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REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS acknowledges that these are generally accepted vulnerable populations; however, the statements are not referenced, and the basis on which these populations are considered vulnerable is not stated (e.g., whether they are susceptible because of greater exposure, such as that due to foodconsumption patterns of fish, or because of personal characteristics, such as pregnancy or age)
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From page 19... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS As with the contaminant data, the rationale and criteria for choosing the CHSR data are not provided. The 2007 draft states that data "were utilized because of their availability" but does not state what alternatives were considered and does not discuss other potentially relevant datasets.
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From page 20... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS With respect to biologic plausibility, health indicators with no plausible direct relationship to contaminant exposure (such as being a teen mother, an older mother, or an unmarried mother; homicide; and lack of first-trimester prenatal care) have no clear role in the assessment.
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From page 21... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS Elevated cancer mortality was also seen for breast cancer in 17 AOCs, colon cancer in 16 AOCs, and lung cancer in 12 AOCS (see Table 7.2)
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From page 22... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS • Chapter 7 (Section 7.4) states that "no causal inference or associations are made in this report," but this statement is followed by lists of putatively increased rates.
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From page 23... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS regarding many of the hazardous-waste sites discussed, but in the conclusions the sites are considered to be of concern without any accounting of the uncertainty of those assessments. Problems previously discussed regarding health-outcome data are amplified in the conclusions section of the 2007 draft.
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From page 24... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS BOX 5 Example of Conclusion That Was Not Justified by Report Contents The executive summary states "this report serves to highlight the pressing need for better data, properly collected, organized, and analyzed, to help define threats to human health and optimal strategies for protecting health." BOX 6 Example of Recommendation That Was Not Justified by Report Contents The Recommendations section contains the further statements that "ATSDR strongly supports the need .
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From page 25... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS human disease outcomes, the possibility of alarming the public, and the inadequate consideration of the potential for actual exposures. And some recommended further review by states in which the AOCs are located, which ATSDR appears to have obtained.
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From page 26... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS After the preparation of the 2007 report draft, the Offices of the Directors of ATSDR and CCEHIP had concerns about it, and ATSDR prepared a statement (ATSDR, 2008c) expressing those concerns about its content.
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From page 27... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS improved. However, as a document confined to summarizing existing data that still have substantial limitations, the 2008 draft adds little to the understanding of Great Lakes AOC contaminants.
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From page 28... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS clarity in ATSDR's options for conducting such projects, and the rationale for the various choices of datasets and analytic methods that were made. The planning stages should include consideration of who should be involved in the project.
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From page 29... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS analysis was included to provide a basis for presenting and synthesizing data from multiple sources in the same tables or to quantify uncertainties. The committee believed that the data were summarized and described in a manner that could encourage the reader to reach conclusions not supported by evidence.
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From page 30... ...
REVIEW OF ATSDR'S GREAT LAKES REPORT DRAFTS CHSR data pre-empted any concerns of reviewers regarding those data, but narrowed the potential utility of the report draft by excluding any consideration of health outcomes beyond the health data compiled in ATSDR's existing health evaluations. Reviewer comments on the contaminant data and the need for further discussion of availability of data were not addressed.
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