The 2019 ISA concludes that “[t]he strongest evidence of an effect of short-term PM2.5 exposure on respiratory effects is provided by epidemiologic studies of asthma and COPD exacerbation. Research Triangle Park, NC. U.S. EPA. Compared to total (non-accidental) mortality (discussed above), fewer studies have examined the shape of the concentration-response curve for cause-specific mortality outcomes, including lung cancer. Most coarse mode mass is captured by PM10-2.5 sampling, but small fractions of coarse mode mass can be smaller than 2.5 μm or greater than 10 μm in diameter (U.S. EPA, 2019, section 2.2). A discussion of measurement uncertainty for FRM, FEM, CSN, and IMPROVE monitors was also added. The Elizabeth Lab site in Elizabeth, NJ is situated approximately 30 meters from travel lanes of the Interchange 13 toll plaza of the New Jersey Turnpike and within 200 meters of travel lanes for Interstate 278 and the New Jersey Turnpike. at lags of 0 to 1 days in single-pollutant models. See Lead Industries Ass'n v. EPA, 647 F.2d at 1161-62; Mississippi v. EPA, 744 F.3d at 1353. The Administrator notes that the results of these updated analyses are consistent with the results from the last review. For visibility impairment, this conclusion reflects his consideration of the evidence for PM-related light extinction, together with his consideration of updated analyses of the protection provided by the current secondary PM2.5 and PM10 standards. Thus, as in the last review, the PA concludes that the data remain insufficient to conduct quantitative analyses for PM effects on climate in the current review (U.S. EPA, 2020, section 5.2.2.2.1). A number of the documents that are relevant to this proposed decision are available through the EPA's website at https://www.epa.gov/​naaqs/​particulate-matter-pm-air-quality-standards. Additional studies conducted in the U.S. or Europe similarly report that reductions in ambient PM2.5 are associated with improvements in longevity (U.S. EPA, 2019, section 11.2.2.5). For the only other cause-specific mortality endpoint evaluated (i.e., lung cancer), substantially fewer deaths were estimated (U.S. EPA, 2020, section 3.3.2, e.g., Figure 3-5). December 2009. Additionally, the organic and nutrient content of deposited PM may enhance microbial growth on surfaces. Pitchford, M, Maim, W, Schichtel, B, Kumar, N, Lowenthal, D and Hand, J (2007). Sci Total Environ 400(1-3): 415-424. The 2012 decision on the adequacy of the secondary PM standards was based on consideration of the protection provided by those standards for visibility and for the non-visibility effects of materials damage, climate effects and ecological effects. The ISA concluded that evidence was “sufficient to conclude that a causal relationship exists between PM and effects on materials” (U.S. EPA, 2009c, sections 2.5.4 and 9.5.4). IPCC AR5 reports a best estimate of ERFari+aci of −0.90 (−1.9 to −0.1) Wm−2, consistent with these estimates (Boucher, 2013). Washington, DC. Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). The EPA's rationales for not revising the other causality determinations questioned by the CASAC are discussed above in sections II.B.1.d (i.e., for cancer) and II.B.1.e (i.e., for nervous system effects). In response to the CASAC's comments, the final PA [16] However, despite continuing research and the strong evidence supporting a causal relationship with climate effects (U.S. EPA, 2019, section 13.3.9), the Administrator notes that there are still significant limitations in quantifying the contributions of the direct and indirect effects of PM and PM components on climate forcing (U.S. EPA, 2020, sections 5.2.2.1.1 and 5.4). The prior Administrator concluded that the varying concentrations of coarse particles that would be permitted in urban versus non-urban areas under the 24-hour PM10 standard, based on the varying levels of PM2.5 present, appropriately reflected the differences in the strength of evidence regarding coarse particle health effects. The revised IMPROVE algorithm (Pitchford et al., 2007) uses major PM chemical composition measurements and relative humidity estimates to calculate light extinction. Interventions to reduce ambient particulate matter air pollution and their effect on health. Boyle, L, Burton, PD, Danner, V, Hannigan, MP and King, B (2017). A pilot focus group study was also conducted for Washington, DC (Abt Associates, 2001), and a replicate study with 26 participants was also conducted for Washington, DC (Smith and Howell, 2009). Denver, CO. Beloin, NJ and Haynie, FH (1975). In this discussion of non-visibility welfare effects, haze is used as it has been defined in the scientific literature on soiling of glass, i.e., the ratio of diffuse transmitted light to direct transmitted light (Lombardo et al., 2010). . The EPA added new standards, using PM2.5 as the indicator for fine particles (with PM2.5 referring to particles with a nominal mean aerodynamic diameter less than or equal to 2.5 µm). This action does not change existing regulations; it proposes to retain the current primary NAAQS for PM, without revision. . A small number of studies provided preliminary evidence that PM exposure can lead to changes in methylation of DNA, which may contribute to biological events related to cancer. As in the last review, these uncertainties contribute to the conclusions in the 2019 ISA that the evidence for the PM10-2.5-related health effects discussed in this section is “suggestive of, but not sufficient to infer” causal relationships. Using National Ambient Air Quality Standards for fine particulate matter to assess regional wildland fire smoke and air quality management. In the last review of the PM NAAQS, completed in 2012, the EPA retained the secondary 24-hour PM2.5 standard, with its level of 35 μg/m3, and the 24-hour PM10 standard, with its level of 150 µg/m3 (78 FR 3228, January 15, 2013). Appendix K to Part 50 - Interpretation of the National Ambient Air Quality Standards for Particulate Matter Appendix L to Part 50 - Reference Method for the Determination of Fine Particulate Matter as PM2.5 in the Atmosphere In the last review, little information was available from studies of cancer following inhalation exposures to PM10-2.5. New economic and environmental considerations beyond aesthetic appeal and structural damage are emerging (U.S. EPA, 2019, section 13.4.3). This conclusion is based on concerns that (1) “the risk assessment treats regression coefficients as causal coefficients with no justification or validation provided for this decision;” (2) the estimated regression concentration-response functions “have not been adequately adjusted to correct for confounding, errors in exposure estimates and other covariates, model uncertainty, and heterogeneity in individual biological (causal) [concentration-response] functions;” (3) the estimated concentration-response functions “do not contain quantitative uncertainty bands that reflect model uncertainty or effects of exposure and covariate estimation errors;” and (4) “no regression diagnostics are provided justifying the use of proportional hazards . The EPA keeps a complete list of designated reference and equivalent methods available on its Ambient Monitoring Technology Information Center (AMTIC) website (https://www.epa.gov/​amtic/​air-monitoring-methods-criteria-pollutants). Circuit rejected all remaining challenges to the standards, holding that the EPA's PM2.5 standards were reasonably supported by the administrative record and were not “arbitrary and capricious.” American Trucking Associations v. EPA, 283 F. 3d 355, 369-72 (D.C. Cir. Washington, DC. Bond, TC, Doherty, SJ, Fahey, DW, Forster, PM, Berntsen, T, Deangelo, BJ, Flanner, MG, Ghan, S, Kärcher, B, Koch, D, Kinne, S, Kondo, Y, Quinn, PK, Sarofim, MC, Schultz, MG, Schulz, M, Venkataraman, C, Zhang, H, Zhang, S, Bellouin, N, Guttikunda, SK, Hopke, PK, Jacobson, MZ, Kaiser, JW, Klimont, Z, Lohmann, U, Schwarz, JP, Shindell, D, Storelvmo, T, Warren, SG and Zender, CS (2013). Compared to PM2.5 mass, there is relatively little data on U.S. particle number concentrations, which are dominated by UFP. (U.S. EPA, 2019, section 13.2.2.2). Available at: https://cfpub.epa.gov/​ncea/​isa/​recordisplay.cfm?​deid=​310244. At the same time, the CAA directs the CASAC to provide advice on “any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance” of the NAAQS to the Administrator under section 109(d)(2)(C)(iv). 23. This includes generally positive associations observed in multicity epidemiologic studies of emergency department visits and hospital admissions for IHD, HF, and combined cardiovascular-related endpoints. Climate change 2013: The physical science basis. should verify the contents of the documents against a final, official that has the same terminal settling velocity as the particle of interest (U.S. EPA, 2019, section 4.1.1). This approach recognizes that changes in PM2.5 air quality designed to meet either the annual or the 24-hour standard would likely result in changes to both long-term average and short-term peak PM2.5 concentrations and that the protection provided by the suite of standards results from the combination of all of the elements of those standards (i.e., indicator, averaging time, form, level). 14. As in the last review, this evidence continues to demonstrate a causal relationship between ambient PM and effects on visibility (U.S. EPA, 2019, section 13.2). A number of studies have also found materials damage from PM components besides sulfate and black carbon and atmospheric gases besides SO2. With these concerns in mind, the EPA re-evaluated the evidence and note that animal toxicological studies were conducted in “multiple research groups [and show a range of effects including] inflammation, oxidative stress, morphologic changes, and neurodegeneration in multiple brain regions following long-term exposure of adult animals to PM2.5 CAPs” (U.S. EPA, 2019, p. 8-61). Another study found damage to cement renders, often used for restoration, consolidation, and decorative purposes on buildings, following exposure to sulfuric acid, resulting in the formation of gypsum (Lanzon and Garcia-Ruiz, 2010). Additional uncertainties associated with using the PM2.5 concentrations reported by key epidemiologic studies to inform conclusions on the primary PM2.5 standards result from the fact that (1) epidemiologic studies do not identify specific PM2.5 exposures that result in health effects or exposures below which effects do not occur and (2) exposure estimates in some recent studies are based on hybrid modeling approaches for which performance depends on the availability of monitoring data and varies by location. The scientific evidence reviewed in the 2009 PM ISA was “sufficient to infer a causal relationship between long-term PM2.5 exposure and cardiovascular effects” (U.S. EPA, 2009c). . Abt Associates, Inc. (2001). Exposure to acidic pollutants in urban environments have been found to reduce the solar reflectance of marble, decreasing the cooling effect (Rosso et al., 2016). These committee members assert that “the conclusions from the risk assessment do not comprise valid empirical evidence or grounds for revising the current NAAQS” (Cox, 2019a, p. 9 consensus responses). Experimental evidence for other outcomes was also limited, with one animal toxicological study reporting that long-term exposure to PM2.5 CAPs results in morphological changes in the nasal airways of healthy animals. The prior Administrator concurred with the PA conclusions and with the CASAC's advice. OSHA's letters of interpretation specifically addressing IAQ issues can be found in Other Resources. They assert that recent studies “mainly confirmed what had already been anticipated or assumed in setting the 2012 NAAQS” (Cox, 2019a, p. 8 consensus responses) and do not provide a basis for revising the current standards. Recent cohort studies provide additional support for the relationship between long-term PM2.5 exposure and decrements in lung function growth (as a measure of lung development), indicating a robust and consistent association across study locations, exposure assessment methods, and time periods (U.S. EPA, 2019, section 5.2.13). In addition, pseudo-design values are averaged over multiyear study periods of varying lengths, rather than reflecting the three-year averages of actual design values; analyses necessarily focus on locations with at least one PM2.5 monitor, while unmonitored areas are not included; and recent changes to PM2.5 monitoring requirements are not reflected in analyses of pseudo-design values. Administrator's Proposed Decision on the Current Primary PM, 2. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room was closed to public visitors on March 31, 2020, to reduce the risk of transmitting COVID-19. In Whitman, the Court clarified that most of that advice would be relevant to implementation but not standard setting, as it “enable[s] the Administrator to assist the States in carrying out their statutory role as primary implementers of the NAAQS.” Id. documents in the last year, 968 In particular, nationwide studies of older adults (65 years and older) using Medicare records report positive associations between PM2.5 exposures and hospital admissions for HF (U.S. EPA, 2019, section 6.1.3.1). By number, most nucleation mode particles fall into the UFP size range, though some fraction of the nucleation mode number distribution can extend above 0.1 μm in diameter. Comparative studies of encapsulation and glass surface modification impacts on PV performance in a desert climate. As in past reviews, the EPA's approach recognizes that there is no bright line clearly directing the choice of standards. Dust has traditionally been classified as scattering, but a recent study found that dust may be substantially coarser than currently represented in climate models, and thus more light-absorbing (Kok et al., 2017). To resolve these biases, a revised IMPROVE equation was developed (Pitchford et al., 2007). Memorandum to PM NAAQS Review Docket (EPA-HQ-OAR-2007-0492). 13. It is not an official legal edition of the Federal In the current review, despite the expanded body of evidence for PM10-2.5-related health effects, the Administrator recognizes that similar uncertainties remain. Methods have been developed for accelerating the aging process of roofing materials to better characterize the impact of soiling and natural weather on materials used in constructing cool roofs (Sleiman et al., 2014). rendition of the daily Federal Register on FederalRegister.gov does not In ambient air, PM is a mixture of substances suspended as small liquid and/or solid particles (U.S. EPA, 2019, section 2.2). The prior Administrator next considered what specific revisions to the existing primary PM2.5 standards were appropriate, given the available evidence and quantitative risk information. Pope, CA, III, I, Burnett, RT, Thurston, GD, Thun, MJ, Calle, EE, Krewski, D and Godleski, JJ (2004). Relative humidity data are also needed to estimate the contribution by liquid water that is in solution with the hygroscopic components of PM. In the absence of evidence from experimental studies that PM2.5 exposures typical of areas meeting the current annual and 24-hour standards can activate biological pathways that plausibly contribute to serious health outcomes, the Administrator is cautious about placing too much weight on reported PM2.5 health effect associations for air quality Start Printed Page 24120meeting those standards. Therefore, the inputs to these light extinction calculations are based on 24-hour average measurements of PM2.5 mass and components, rather than sub-daily information. The generally positive associations between short-term PM2.5 exposure and asthma and COPD emergency department visits and hospital admissions are supported by epidemiologic studies demonstrating associations with other respiratory-related effects such as symptoms and medication use that are indicative of asthma and COPD exacerbations (U.S. EPA, 2019, sections 5.1.2.2 and 5.4.1.2). EPA-452/R-10-004 July 2010. This relationship is further supported by a recent retrospective study that reports an association between declining PM2.5 concentrations and improvements in lung function growth in children (U.S. EPA, 2019, section 5.2.11). Ozga, I, Bonazza, A, Bernardi, E, Tittarelli, F, Favoni, O, Ghedini, N, Morselli, L and Sabbioni, C (2011). Lee, YH, Lamarque, JF, Flanner, MG, Jiao, C, Shindell, DT, Berntsen, T, Bisiaux, MM, Cao, J, Collins, WJ, Curran, M, Edwards, R, Faluvegi, G, Ghan, S, Horowitz, LW, McConnell, JR, Ming, J, Myhre, G, Nagashima, T, Naik, V, Rumbold, ST, Skeie, RB, Sudo, K, Takemura, T, Thevenon, F, Xu, B and Yoon, JH (2013). Atmos Chem Phys 13(5): 2607-2634. Results from copollutant models generally support an independent effect of PM2.5 exposure on mortality. Public Perception of Visibility Impairment, D. Proposed Conclusions on the Current Secondary PM Standards, 1. U.S. National Institutes of Health. Preference studies were available in four urban areas in the last review. 5-11 to 5-12) and that there was insufficient information available to base a national ambient air quality standard on climate impacts associated with ambient air concentrations of PM or its constituents (U.S. EPA, 2011, section 5.2.3). Seasonal analyses indicate that ambient PM10 concentrations are generally higher in the summer months than at other times of year, though the most extreme high concentration events are more likely in the spring (U.S. EPA, 2019, Table 2-5). 18. Building on the evidence available in the 2009 ISA, research has progressed on the theoretical understanding of soiling of cultural heritage in a number of studies. Accordingly, while some of these issues regarding which Congress has directed the CASAC to advise the Administrator are ones that are relevant to the standard setting process, others are not. Since the last review, Lowenthal and Kumar (2016) further offered a number of modifications to the revised IMPROVE equation, with a focus of the application of the IMPROVE equation in remote sites. In the 2009 ISA, one of the main uncertainties identified was the regional and city-to-city heterogeneity in PM2.5-mortality associations. 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