Review of EPA's 2022 Draft Formaldehyde Assessment (2023) / Chapter Skim
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Appendix C: Case Study: Hanrahan et al. (1984), Human Sensory Irritation
Appendix C: Case Study: Hanrahan et al. (1984), Human Sensory Irritation
Pages 129-141
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From page 129... ...
FIGURE C-1 The eight-step process for literature identification, outcome-specific study methods, synthesis of results, synthesis and evidence integration judgments, and dose-response study selection, outlined by the U.S. Environmental Protection Agency (EPA)
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From page 130... ...
Overall, the literature search terms, inclusion and exclusion criteria, and PECO statement are appropriately inclusive of relevant studies for assessing human sensory irritation. STEP 3: OUTCOME-SPECIFIC EVALUATION CRITERIA EPA provided outcome evaluation criteria for human observational and animal/human experimental studies in Appendix A.5.1, with sensory irritation–specific criteria in Appendix A.5.2.
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From page 131... ...
Study Quality Criteria and Bases for Confidence Ratings for Human Sensory Irritation Studies Locations for Criteria in Appendix General Exposure Sensory Description of Confidence Rating Criteria Text Criteria Text Irritation from Table A-33 (approximate Study Quality Criteria of A.5.1 of A.5.1 Table A-33 matching to appropriate criteria) Selection Bias Recruitment, selection into study, participation X N/A X NI: Selection bias away from null independent of exposure Sufficient reporting detail NI: Methods description too sparse about subject identification X N/A for evaluation a and selection Information Bias High: Exposure assessment timing Exposure assessment timing appropriate for outcome observation; appropriate for outcome X N/A X Med: Uncertainty in timing between observation exposure and outcome assessment Reporting of distribution and X X range of exposure Adequate contrast between X X NI: Exposure range <0.1 mg/m3 high and low exposure Exposure measurement X duration and frequency Consideration of temp, RH, X quality control For <1 day exposure measurement, details of Low: <1 day exposure measure measurement protocol and X X without protocol discussion and influence of sources of quality control exposure should be included LOD and percent < LOD X High: Exposure assessment designed Conc.
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From page 132... ...
The final column provides EPA's confidence rating information provided, matched with the corresponding study quality criteria (as determined by the committee, because EPA did not provide the specific domains when describing the characteristics of high, medium, low, and not informative studies)
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From page 133... ...
SOURCE: Table A-34 of A.5.2, Appendix A of EPA's 2022 Draft Formaldehyde Assessment. Table C-2 shows a comparison of the study quality criteria and descriptions provided by EPA for sensory irritation, with the findings reported for Hanrahan et al.
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From page 134... ...
Protocol influence of sources includes QC but not of exposure should LOD be included LOD and percent LOD 0.12 mg/m3 The study does not report < LOD a LOD Concentration High: Exposure Average of 1-hr samples Limited sampling <1 day exposure measure captures assessment designed from two rooms period measurement, unclear if mean individual to characterize mean this is categorized as exposure exposures "more limited" Med: More limited exposure assessment Validated data High: Validated data Self-report questionnaire, Questionnaire not Medium = less well collection collection instrument no description described described; unclear how instrument used and used & described EPA rates "no described Med: instrument less description" well described Outcome High and Med: Response blind to ascertainment Outcome formaldehyde independent of ascertainment measurements exposure knowledge independent of exposure knowledge Timing of outcome High and Med: [No information noted] Outcome assessment and assessment with Symptom assessment exposure assessment exposure assessment concurrent with done at the same time exposure assessment (although outcome involved recall for entire time in the house)
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From page 135... ...
Quantitative results High: Quantitative Logistic regression, Only one figure reported presented results provided provided graph of regression results, no predicted mean prevalence info about regression normalized to mean age, coefficients and fit, no and upper and lower 95% other results presented, confidence interval by no reporting of primary concentration from results regression model Other considerations not No Issues Noted in otherwise evaluated Summary Diagram Sensitivity [No information noted] (exposure levels, exposure contrast, duration of follow up, outcome ascertainment)
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From page 136... ...
EPA did not call out this deficiency in the Analysis category or in the summary figure. Inconsistencies are also apparent in how study quality deficiencies are represented in the four-domain summary confidence figure for human sensory irritation studies.
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From page 137... ...
For human sensory irritation, the information that applied to the synthesis judgments is described in the text of the main document in Section 1.2.1, under the title Integrated Summary of Evidence on Sensory Irritation. EPA determined that the strength of evidence was robust, and they provided information that addressed risk of bias, consistency, biological gradient/dose-response, coherence, mechanism/biological plausibility, and other considerations (from Table VI; the set of studies includes varied populations)
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From page 138... ...
Additionally, EPA provided endpoint-specific dose-response study selection considerations in Section 2.1.1. For sensory irritation, it stated that studies that conducted the exposure assessment concurrently with the outcome assessment were the most informative for RfC derivation because formaldehyde induces a rapid irritant response.
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From page 139... ...
Complete results reporting No selection bias, information bias, or confounding that substantially alters interpretation of results Accuracy of exposure assessment Severity of observed effectsa Animal studies: used paraformaldehyde as test article Animal studies: longer exposure duration and follow-up Animal studies: adequately powered to detect effects at lower levels Population Human studies preferred over animals Dose-response from most susceptible subgroup, as appropriate (and available) Human studies: preference for study groups from general population (e.g., residences, schools)
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From page 140... ...
complete results reporting symptoms and and fit, no other results graph of predicted presented, no reporting of prevalence of primary results burning eyes Study No selection bias, information bias, or Confidence Some information bias from confounding that substantially alters No info on survey used lack of survey info interpretation of results 1-hr exposure Very short exposure Accuracy of exposure assessment measurement assessment Eye irritation Severity of observed effects ("burning eyes") High- or medium-confidence study Medium confidence Concurrent 1-hr The assessments were Concurrent exposure and outcome measure and survey for concurrent, but the outcome assessment a symptoms since applied to anytime since moving into home moving into home continued
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From page 141... ...
. BMD = benchmark dose; C-R = concentration response; LOAEL/NOAEL = lowest observed effect level/ no observed effect level; LOD = limitation of detection SOURCE: EPA's 2022 Draft Formaldehyde Assessment; Hanrahan et al.
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