multiple pollutants. In presenting <strong>the</strong> results, it would also be useful to complement in<strong>for</strong>mationon pollutant effects estimators with in<strong>for</strong>mation on actual pollutant levels so that <strong>the</strong> role <strong>of</strong> <strong>the</strong>individual pollutants would be more apparent.Page 6-42, line 7 and page 6-43, line 6. It would be useful <strong>for</strong> <strong>the</strong> CD to include an expandeddiscussion <strong>of</strong> <strong>the</strong> handling <strong>of</strong> county-specific variables and co-pollutants in <strong>the</strong> NMMAP studies.Specifically, it would be useful to include one or more tables that present specific data on <strong>the</strong>effects estimators used <strong>for</strong> o<strong>the</strong>r pollutants such as NO 2 , O 3 , SO 2 , and CO and <strong>for</strong> temperature(both elevated and reduced). This would be helpful in understanding <strong>the</strong> total air pollution effectand <strong>the</strong> relative importance <strong>of</strong> PM. It is not sufficient (as in page 6-44, line 2-3) to relate that <strong>the</strong>PM 10 effect on mortality "did not appear to be affected by o<strong>the</strong>r pollutants in <strong>the</strong> model."In presenting <strong>the</strong> NMMAPS results it would be useful to include a graphical display that conveys<strong>the</strong> slope <strong>of</strong> <strong>the</strong> effects estimators <strong>for</strong> <strong>the</strong> 90 cities. At a minimum, <strong>the</strong> regional data could beplotted relative to <strong>the</strong> measured range <strong>of</strong> PM 10 values used to derive <strong>the</strong> effects estimators. Thelatter values might be <strong>the</strong> 25 th to 75 th or 10 th to 90 th percentile <strong>of</strong> <strong>the</strong> PM 10 values that were usedin <strong>the</strong> analyses plotted on <strong>the</strong> horizontal and <strong>the</strong> mortality rate on <strong>the</strong> vertical.Page 6-49, section 6.2.2.4 (The Role <strong>of</strong> <strong>Particulate</strong> <strong>Matter</strong> Components). This section shouldei<strong>the</strong>r begin with or end with a discussion <strong>of</strong> <strong>the</strong> challenge <strong>of</strong> characterizing <strong>the</strong> role <strong>of</strong> specificparticulate matter components. Two major issues should be covered. First, epidemiologicalanalyses can only be carried out on <strong>the</strong> components that have been measured. In that regard, amajor problem relates to <strong>the</strong> past excessive domination <strong>of</strong> monitoring by concern <strong>for</strong> regulatorycompliance, with a progression in <strong>the</strong> U.S. from TSP to PM 10 and most recently to PM 2.5measurements and with measurements <strong>of</strong> PM indicators made only every 6 th day. The ability totest <strong>for</strong> <strong>the</strong> role <strong>of</strong> o<strong>the</strong>r components that may be significant will continue to be dependent uponhaving long-term measurements <strong>of</strong> <strong>the</strong>se components. The second issue is <strong>the</strong> challenge <strong>of</strong>teasing out very small relative risks. It is apparent, and especially from <strong>the</strong> staff paper, that largestudy sizes are needed to obtain relatively stable and statistically significant results—studies <strong>for</strong>which <strong>the</strong> product <strong>of</strong> number <strong>of</strong> mortality/morbidity events per day multiplied by <strong>the</strong> number <strong>of</strong>days monitored is at least 10,000.Page 6-58, lines 19-20: The statement indicating that wind-blown endotoxins and molds arecontributing to PM10-2.5 fraction effects in <strong>the</strong> Phoenix area needs to be supported byreferences or omitted if it is mere speculation.Page 6-58, line 2.7. In view <strong>of</strong> <strong>the</strong> role <strong>of</strong> SO 2 in <strong>the</strong> Wichmann, et al (2000) study, it would beappropriate to give an indication <strong>of</strong> <strong>the</strong> SO 2 levels measured and how <strong>the</strong>y compare to levelsmeasured in <strong>the</strong> eastern U.S.Page 6-67, Source-Disputed Evaluation: It would be useful to review <strong>the</strong> analyses done by <strong>the</strong>NMMAPS investigators (perhaps even unpublished analyses) to determine if any <strong>of</strong> <strong>the</strong> resultsprovide any insights into source-oriented impacts. For example, did <strong>the</strong> NMMAPS investigatorsexplore any weekday versus weekend effects that might give insights into mobile source relatedeffects?Page 6-72, line 1: Show <strong>the</strong> Confidence Interval <strong>for</strong> excess o<strong>the</strong>r deaths; i.e., 1.3% increase per50 :g/m 3 PM 10 . It would also be appropriate to expand <strong>the</strong> discussion <strong>of</strong> o<strong>the</strong>r deaths to considerregional differences.Page 6-73, lines 28-30: It would be useful to expand <strong>the</strong> discussion <strong>of</strong> sample size issues <strong>for</strong>sub-categories <strong>of</strong> disease. This could be done using <strong>the</strong> study size calculations in <strong>the</strong> staff paper<strong>for</strong> <strong>the</strong> NMMAP study showing how <strong>the</strong> study size decreases progressing from total mortality tocardiac to respiratory causes because <strong>of</strong> decreases in number <strong>of</strong> events. This discussion could beA - 59
tied back to <strong>the</strong> base-line health statistics presented in Chapter 9 (tables 9-9 and 9-10).Page 6-77, lines 23-26: The summary statement on biogenically-derived particles in <strong>the</strong> PM 10-2.5fraction in this reviewer’s opinion is over-stated relative to <strong>the</strong> evidence. If <strong>the</strong> statement isretained, it must be backed up with specific evidence.Page 6-80, lines 5-6: In view <strong>of</strong> <strong>the</strong> emphasis given to <strong>the</strong> relative risks <strong>for</strong> PM 2.5 derived from<strong>the</strong> ACS study, it would be useful to briefly describe <strong>the</strong> methodology used in <strong>the</strong> ACS study toarrive at PM 2.5 values.Pages 6-86 and 6-91 were missing from all copies <strong>of</strong> <strong>the</strong> CD provided to me.Page 6-102, line 17 to page 6-103, line 4: It would be useful to give <strong>the</strong> low, medium, and highPM 10 levels studied as an aid to relating <strong>the</strong> research to contemporary PM 10 levels in <strong>the</strong> U.S.Page 6-133, Individual-Level Studies <strong>of</strong> Cardiovascular Physiology. This section could bestreng<strong>the</strong>ned by including a discussion on <strong>the</strong> statistical problems <strong>of</strong> detecting small increases in"signals" <strong>for</strong> "low prevalence effects." This could be done by considering <strong>the</strong> minimum studysizes needed to give statistically significant effects <strong>for</strong> cardio-respiratory mortality (per staffpaper) and <strong>the</strong>n applying <strong>the</strong>se minimum sizes to <strong>the</strong> individual level studies that sought toidentify more subtle morbidity indicators.Page 6-175, line 15 to page 6-176, line 17: In discussing <strong>the</strong> association <strong>of</strong> increased levels <strong>of</strong>PM and o<strong>the</strong>r pollutants with asthma, it would be useful to include in<strong>for</strong>mation on <strong>the</strong> effectsestimators <strong>for</strong> <strong>the</strong> o<strong>the</strong>r pollutants used in <strong>the</strong> various analyses. This will place <strong>the</strong> PM effects inperspective relative to o<strong>the</strong>r pollutants.Page 6-177, line 27. This discussion needs to be expanded and integrated with data presented intables 9-9 and 9-10.Page 6-222, line 3: This would be an appropriate place to discuss <strong>the</strong> effects estimators <strong>for</strong>PM 10 , O 3 , NO 2 , SO 2 , and CO, provide an indication <strong>of</strong> typical levels, and discuss <strong>the</strong> relativecontribution <strong>of</strong> each <strong>of</strong> <strong>the</strong> indicators to <strong>the</strong> total air pollution effect.Page 6-245, Section 6.4.6, New Assessment <strong>of</strong> Threshold in Concentration-ResponseRelationships. The issues that should be discussed in this section go well beyond consideringthresholds. This reviewer suggests <strong>the</strong> section be re-titled – "Ambient Concentration – ResponseRelationships <strong>for</strong> PM Indicators." This is not merely an issue <strong>of</strong> threshold versus linearrelationships. The discussion should start with presentation <strong>of</strong> in<strong>for</strong>mation on background levels<strong>of</strong> PM 10 and PM 2.5 , discussed elsewhere in <strong>the</strong> CD, and how one bridges from background levelsto ambient concentrations that show excess risk.The discussion could <strong>the</strong>n proceed to consideration <strong>of</strong> <strong>the</strong> range <strong>of</strong> PM indicator concentrationsevaluated. This might include population-weighted data <strong>for</strong> some studies, such as <strong>the</strong> NMMAPstudy. The section should include a summary statement concerning <strong>the</strong> calculation <strong>of</strong> populationimpacts <strong>of</strong> PM exposure. In my opinion, this would include a statement concerning <strong>the</strong>inclusion/exclusion <strong>of</strong> lowest quartile or lowest half <strong>of</strong> ambient levels <strong>of</strong> PM in calculating PMimpacts <strong>for</strong> populations.Page 6-258, line 29, Heterogenicity <strong>of</strong> <strong>Particulate</strong> <strong>Matter</strong> Effects Estimates: The sectioncould be improved by providing additional baseline data, especially relative to <strong>the</strong> NMMAP 90-city study. This could include inclusion <strong>of</strong> a table showing <strong>the</strong> average baseline rate (totalmortality, cardiac and respiratory) <strong>for</strong> each <strong>of</strong> <strong>the</strong> cities studied, along with total population size.The baseline mortality <strong>for</strong> each cause might be shown <strong>for</strong> each city since this was <strong>the</strong> baseA - 60
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