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Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Rules and Regulations
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TABLE 1AGGREGATE DISABILITY CLAIMS DATA BY COHORTContinued GW 1
deployed
GW 1-era nondeployed
GWOT
deployed
GWOT-era non-deployed
K2 cohort subset
Totals across cohorts
Rhinitis Claims
Claims Rate 1
Grants
Grant Rate 2

16,684
2.2%
8,405
49.3%

26,094
1%
14,131
54.2%

276,609
11.3%
206,348
74.6%

91,063
3.5%
64,522
70.9%

1,564
10%
1,198
76.6%

410,810
4.9%
293,406
71%

195,747
8%
87,151
44.5%

65,863
2.5%
29,849
45.3%

1,206
7.7%
571
47.3%

322,137
3.8%
145,104
45%

123,739
5%
62,971
50.9%

46,180
1.8%
25,209
54.6%

435
2.8%
210
48.3%

212,805
2.5%
108,543
51%

Sinusitis Claims
Claims Rate 1
Grants
Grant Rate 2

22,787
2.2%
9,869
43.3%

37,740
1.4%
18,235
48.3%
Asthma
Claims
Claims Rate 1
Grants
Grant Rate 2

18,126
2.4%
7,453
41.8%

25,052
1%
12,910
51.5%

VBA Corporate Data, as of April 2021.
1 Claims Rate is the percentage of cohort who filed a claim for service connection.
2 Grant Rate is percentage of claims granted service connection.

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This increased volume of claims and the sheer number of grants within the deployed cohorts for these conditions was critical in determining that more scientific review was necessary.
f. EPAs 2019 Integrated Science Assessment for Particulate Matter The Environmental Protection Agencys EPAs Integrated Science Assessment ISA is a comprehensive evaluation and synthesis of policyrelevant science aimed at characterizing exposures to ambient particulate matter PM, and health and welfare effects associated with these exposures. The evaluation of the science and the overarching conclusions of the ISA
serves as the scientific foundation for the review of the primary health-based and secondary welfare-based National Ambient Air Quality Standards for Particulate Matter in the United States.
EPAs ISA is prepared through a structured and transparent process that includes review by a formal independent panel of scientific experts specifically, the Clean Air Scientific Advisory Committee and by the public.7 The ISA uses a formal causal framework to classify the weight of the evidence for health effects.
The EPAs causal framework and approach to evaluating the scientific evidence that informs the corresponding 7 See, e.g., Clean Air Science Advisory Committee CASAC, CASAC Review of the EPAs Integrated Science Assessment for Particulate Matter External Review DraftOctober 2018 Apr. 2019, available at https yosemite.epa.gov/sab/sabproduct.nsf/
6CBCBBC3025E13B4852583D90047B352/$File/
EPA-CASAC-19-002+.pdf.

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causality determinations is outlined in the Preamble To The Integrated Science Assessments ISA available at https cfpub.epa.gov/ncea/isa/
recordisplay.cfm?deid=310244. Within the ISAs, the EPA evaluates and integrates evidence across scientific disciplines to assess the causal nature of relationships between PM and health or welfare effects. Specifically, during the evaluation of the health effects evidence the focus is on assessing consistency of effects within a discipline, coherence of effects across disciplines, and whether there is evidence of biologically plausibility, while also taking into consideration the exposures of studies.
The 2019 PM ISAs, EPA concluded that there is a likely to be causal relationship between both shorti.e., hours up to a month and long-term i.e., month to years exposure to fine particulate matter and respiratory health effects. Their definition of a likely to be causal relationship is as follows, Evidence is sufficient to conclude that a causal relationship is likely to exist with relevant pollutant exposures. That is, the pollutant has been shown to result in health effects in studies where results are not explained by chance, confounding, and other biases, but uncertainties remain in the evidence overall. c.f., Table P2. For long-term PM2.5 exposure, the strongest evidence is for changes in lung function and lung function growth and asthma development in children. For adults there is evidence of acceleration of lung function decline, but inconsistent evidence for asthma development.

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Additionally, there is very limited, and inconsistent evidence of respiratory effects in healthy populations for both shortand long-term PM2.5 exposure.
The strongest evidence is from animal toxicological studies, but this is not consistent with epidemiologic and controlled human exposure studies.
g. VAs Comprehensive Supplemental Literature Review VAs Health Outcomes Military Exposures HOME and the Airborne Hazards and Burn Pits Center of Excellence AHBPCE completed a literature review of asthma, sinusitis, and rhinitis that specifically considered literature on general population exposures to particulate matter in nondeployment settings. Additional relevant literature published after the 2020 NASEM report was identified, and the VA workgroup met to define search parameters and inclusion/exclusion criteria for literature review.
The VA workgroup utilized the PICOTS Patient, Intervention/Exposure, Comparator, Outcomes, Timing, Setting Framework see below, Table 2
PICOTS Framework to strengthen the evidence gathered, which was refined in consultation with the Director of the Veterans Affairs Central Office Library, who conducted the primary search. VA
SMEs also performed a supplemental search to ensure completeness. To incorporate the full range of evidence, human and non-human studies were considered. Human studies refers to observational, case-control, cohort, and meta-analytic studies involving people.

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