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Date 12/06/2012 06:02 PM From "Michael J. Myers" <Michael.Myersag.ny.gov > To "bbershteyn@omb.eop.gov " <bbershteyn@omb.eop.gov > "jcarsonceq.eop.gov " <jcarsonceq.eop.gov >; "jackson. lisaepamail.epa.gov " <jackson. lisaepamail.epa.gov > EPA Final Rule on National Ambient Air Quality Standards for Particulate Matter

On behalf of the Attorneys General of New York, Connecticut, Delaware, Maryland, Massachusetts, New Mexico, Rhode Island, Vermont, and Washington, please see the attached correspondence with attachment. Thank you.

Michael J. Myers Chief, Affirmative Litigation Section
Environmental Protection Bureau New York State Attorney General The Capitol Albany, NY 12224 

### (518) 402-2594 michael.myers@ag.ny.gov

Letter to White House 0MB on PM Standards.pdf State AGs' PM comments Final.pdf

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Message CountAttorneys General of New York, Delaware, New Mexico, Rhode Island, and Vermont

EPA Docket Center (Mail Code 6102T) Attention Docket ID No. EPA-HQ-OAR-2007-0492 1200 Pennsylvania Ave., NW. Washington, DC 20460.

Re: National AmbientAir Quality Standards for Particulate Matter - Proposed Rule 77 Fed. Reg. 38,890 (June 29, 2012) Docket No. EPA-HQ-OAR-2007-0492

Dear Administrator:

The State Attorneys General of New York, Delaware, New Mexico, Rhode Island, and Vermont ("Attorneys General"), respectfully submit these comments on the Environmental Protection Agency's Proposed Rule for the National Ambient Air Quality Standards ("NAAQS") for Particulate Matter ("Proposed Rule"). The Attorneys General focus their comments on the aspect of the Proposed Rule that would strengthen the annual primary NAAQS from 15 micrograms per cubic meter (p.gIm 3 ) to either 12 jlg/m 3 or 13 .tg/m 3 , and would leave in place the current daily (24-hour) primary NAAQS of 35 pg/m 3 . As explained below, in order to comply with the protective mandate of the Clean Air Act, the Attorneys General urge EPA to adopt an annual standard of 12 ig/m 3 and also to strengthen the daily standard to 30 .tgIm3. These standards are vitally important for protecting the citizens of our states -- particularly our children and elderly -- from the adverse health effects of particulate matter air pollution.

The Proposed Rule is a culmination of many years of litigation by the Attorneys General and other parties seeking to compel EPA to issue sufficiently protective standards for particulate matter pollution under the Clean Air Act ("Act"). Congress enacted the statute "to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population." 42 U.S.C. § 7401(b)(1). One of the core elements of achieving this goal is the requirement that EPA promulgate health-based, or "primary," NAAQS for certain criteria pollutants, such as particulate matter, that protect public health with an adequate margin of safety. 42 U.S.C. § 7409(b)(1). EPA also must promulgate welfare-based, or "secondary," NAAQS for particulate matter to adequately protect public welfare. Id., § 7409(b)(2).

To ensure that the air quality standards reflect advances in scientific understanding of the effects of air pollution, the statute requires that "at five-year intervals," EPA must "complete a thorough review of [air] quality criteria published under section 7408 of [the Act] and the national ambient air quality standards promulgated under this section and make such revisions in such criteria and standards and promulgate such new standards as may be appropriate" to ensure adequate protection. , § 7409(d)(1). EPA's promulgation of the NAAQS sets in motion anational implementation process aimed to reduce the pollutant's atmospheric concentration and

to achieve the standards. See American Truckin gAss'ns v. Whitman, 283 F.3d 355, 358-59 (D.C. Cir. 2002). EPA and the states must first designate areas that fail to meet, or attain, the NAAQS. Id. (citing 42 U.S.C. § 7407(d)(1)-(2)). Each state then must adopt a plan providing for the implementation, maintenance, and enforcement of the NAAQS through, for example, the regulation of power plant and automobile emissions. j at 359 (citing 42 U.S.C. § 7410(a)(1)).

Particulate matter ("PM") includes "a broad class of chemically and physically diverse substances that exist as discrete particles (liquid droplets or solids) over a wide range of sizes." 71 Fed. Reg. 61,144, 61,146 (Oct. 17, 2006). Fine particulate matter, or particulate matter less than two and a half micrometers in diameter ("PM 25 ") forms primarily as a result of the combustion of fossil fuel by power plants, motor vehicles, industrial facilities, and residential heating. Id. Because of its microscopic size, PM 2.5 can penetrate deep into the lungs and cause respiratory illness or move into systemic circulation and trigger heart attacks. 61 Fed. Reg. 65,638, 65,648 (Dec. 13, 1996).

In the last particulate matter NAAQS rulemaking, EPA decided not to strengthen the annual standard of 15 .tg/m 3 for PM 2.5

, which it had established in 1997. 71 Fed. Reg. 61,144 (Oct. 17, 2006). In deciding not to strengthen the annual primary NAAQS, the Administrator rejected the recommendations of EPA's Clean Air Scientific Advisory Committee, EPA staff,and numerous medical and public health groups, all of whom had concluded that the thenexisting scientific evidence demonstrated that exposure to fine particulate matter at this level results in respiratory illness and premature mortality. The Attorneys General and other parties filed petitions for review of the NAAQS in the Court of Appeals for the District of Columbia Circuit.

In February 2009, the D.C. Circuit granted the petitions in part. American Farm Bureau Fed'n v. EPA, 559 F.3d 512 (D.C. Cir. 2009). In finding the Administrator's decision on the annual primary NAAQS to be "contrary to law," 559 F.3d at 515, the court emphasized EPA's statutory obligation under the Act to ensure that the NAAQS protected "not only average healthy individuals, but also 'sensitive citizens." Id. at 524 (quoting American Lung Ass'n v. EPA, 134 F.3d 388, 389 (D.C. Cir. 1998)). The Court noted in particular that the Administrator had acted arbitrarily in discounting a study by Gauderman, et al. showing irreversible lung damage to Southern California children exposed to PM 2.5 concentrations at and below 15 Jig/m 3

. j at 528. In addition, the court ruled that the Administrator had acted unreasonably in relying solely on the 24-hour (daily) standard to protect the public health from short-term exposures. The Administrator's decision lacked support in the record and failed reasonably to explain why he decided not to consider evidence from short-term exposure studies in setting the standard. at 521-24. The court remanded the annual PM 2.5 standard to EPA for reconsideration—declining to vacate the existing standard only because the vacatur would have eliminated the existing protection, even if it was "insufficiently protective." at 528.

Although EPA could have reconsidered the 2006 NAAQS based on the existing administrative record, the agency decided not to conduct its review based on preexisting, available information. Instead, EPA indicated in October 2009—eight months after the court's decision—that it would reconsider the annual primary standard for PM 2.5 in the course of its five-year review of the NAAQS, which the Act required EPA to complete by October 16, 2011.

After EPA failed to respond to the court's remand, the Attorneys General filed a mandamus petition in November 2011 on grounds that EPA had unreasonably delayed in responding to the remand. In opposition, EPA submitted an affidavit by Assistant Administrator McCarthy stating that it would propose NAAQS by June 2012 and finalize them by June 2013. "Based upon on the [McCarthy] declaration," the court "anticipate[d] that the agency would work diligently" to meet this schedule and issue final NAAQS by June 2013, "rendering the extraordinary remedy of mandamus unwarranted." Doc. No. 1358778 in D.C. Cir. Case No. 06-14 10.

In February 2012, the Attorneys General filed a lawsuit in federal district court in New York based on EPA's failure to promulgate particulate matter NAAQS by the five-year deadline required under section 109(d)(1) of the Act. State of New York, et al. v. Lisa P. Jackson (S.D.N.Y. Case No. 12-1064). The Attorneys General's case subsequently was transferred to federal district court in the District of Columbia, where it was consolidated with a similar lawsuit that had been filed by several environmental organizations, American Lung Ass'n, et al. v. Lisa P. Jackson (D.D.C. No. I :12-cv-0243). On June 2, 2012, the district court granted the plaintiffs' motion seeking to require EPA to expeditiously promulgate proposed NAAQS, and ordered EPA to sign the proposal by June 7, 2012. Doc. No. 37 in D.D.C. Case No. 1 :12-cv-0243. EPA subsequently successfully moved for an extension of time, until June 14, 2012, to sign the Proposed Rule, which was then published in the Federal Register on June 29, 2012. 77 Fed. Reg. 38,890. The parties negotiated a settlement regarding a deadline for EPA to sign the final rule, which was then memorialized in a consent decree. See Doc. No. 44-1 in D.D.C. Case No. 1:12- cv-0243. Pursuant to the consent decree, EPA must sign the final rule by December 14, 2012.

EPA's Proposed PrimaryNAAOS

EPA has proposed to strengthen the annual primary standard from 15 .tg/m 3 to within a range of 12 jig/m 3 -13 Lg/m 3 . 77 Fed. Reg. at 38,943. The agency proposed to leave the 24-hour primary standard unchanged at 35 .tg/m 3

. 

### i4 EPA further solicited comments on "alternative annual standards down to 11 jg/i and on the combination of annual and 24-hour standards that commenters may believe is appropriate." Id. Under EPA's approach, the annual standard is designed to be the "generally controlling" standard, thereby providing protection against adverse health effects associated with both short-term and long-term exposures to PM 2.5 pollution. jçj at 38,939. The 24-hour standard is designed to provide "supplemental protection, particularly for areas with high peak-to-mean ratios possibly associated with strong local or seasonal sources, or
PM 25 -related effects that may be associated with shorter-than daily exposure periods." 

### i4

The preamble to the Proposed Rule states that '[t]he Administrator recognizes that the final suite of standards selected from within the proposed range of annual standard levels, or the broader range of annual standard levels on which public comment is solicited, must be clearly responsive to the issues raised by the D.C. Circuit's remand of the 2006 primary annual PM2.5 standard." 77 Fed. Reg. at 38,943. To satisfy that obligation to respond to the court's remand, EPA must adopt an annual standard of no higher than 12 tg/m 3 .' The Attorneys General also

The Attorneys General take no position on whether the annual standard should be set at 11 tg/m 3 , other than to note that for the reasons set forth by EPA staff in the Policy Assessment,urge EPA to adopt a 24-hour standard of 30 jig/rn 3 to protect against short-term exposures to

PM 2

, 5pollution.

1. The Annual Standard Must Be Set At 12 tg/m 3Or Lower To Protect Public Health With An Adequate Margin Of Safety.

In this rulemaking, EPA staff concluded that there is now a "stronger and broader body of evidence" than in 2006 that exposure to PM 2,5 causes premature death, breathing problems, and heart disease. EPA, Policy Assessment for the Review of the Particulate Matter National Ambient Air Quality Standards (April 2011) ("Policy Assessment"), at 2-18, 2-35. In addition, a comprehensive research report by the Health Effects Institute, a well-respected researchorganization jointly funded by EPA and industry, found that the association between particulatematter pollution and premature death from heart attacks is even greater than previously estimated. Id. at 2-19. As a result, EPA staff recommended an annual standard significantly below 15 jig/m 3 , with the strongest evidence supporting a standard in the range of 11-12 jig/rn3.
I4 at 2-102. EPA staff further recommended that the Administrator consider lowering the 24- hour standard from 35 jig/m 3 to 30 jig/rn 3 . Id. In its comments on the second draft of the Policy Assessment, EPA's Scientific Advisory Committee found EPA staff's recommendations to be well supported by the scientific evidence. Letter from Dr. Jonathan M. Samet, Chair to Administrator Jackson (Sept. 10, 2010) at i-u. The conclusion that an annual standard of no higher than 12 gig!m 3is necessary to protect public health with an adequate margin of safety is compelled on two grounds: (i) epidemiological studies and (ii) the results of EPA's risk

assessment.

First, as EPA staff concluded in the Policy Assessment, the epidemiological evidence strongly supports setting the annual standard at 12 gg/m 3 , if not lower. In explaining their recommendation that the annual standard be revised down to at least 12 jig/m 3 , EPA staff summarized the evidence in support of such a standard:

[A] standard level of 12 gg/m 3 , at the upper end of this range, is somewhat below the long-term mean PM 2,5 concentrations reported in all the multicity long- and short-term exposure studies that provide evidence of positive and statistically significant associations with health effects classified as having evidence of a causal or likely causal relationship, including premature mortality and hospitalizations and emergency department visits for cardiovascular and respiratory effects as well as respiratory effects in children. Further, a level of 12 jig/m 3 would reflect consideration of additional population-level information from such epidemiological studies in that it is the PM 2

, 5concentration generally corresponding with the 25th percentile of the available distributions of health events data, which we consider to be at the high end of the range of PM 2

, 5concentrations within which the data become appreciably more sparse and, thus, where our confidence in the associations observed in epiderniological studies starts to

with which the Scientific Advisory Committee concurred, the evidence would also appear to support a standard at this level as well as at 12 jig/m3.become appreciably less. In addition, a level of 12 jig/rn 3 would reflect some consideration of studies that provide more limited evidence of reproductive and developmental effects, which are suggestive of a causal relationship, in that it is about at the same level as the lowest long-term
mean PM 25 concentrations reported in such studies.

Policy Assessment at 2-79.

For example, staff cited the Women's Health Initiative study, which reported positive associations between long-term PM 2.5 exposure and cardiovascular-related mortality as well as morbidity effects at an aggregate long-term mean PM 2.5 concentration of 12.9 jig/m 3 (based on updated data received by the EPA). Policy Assessment at 2-32 (citing Miller, et al. (2007)). In addition, several multi-city long-term exposure studies found positive and significant associations for mortality, cardiovascular effects or respiratory effects at mean PM2.5 concentrations ranging from 16.4 to 12.9 jig/m 3 . Krewski, etal. (2009); Miller, etal. (2007); Bell, et al. (2008); Zanobetti and Schwartz (2009). The long-term mean PM 2.5 concentrations
associated with the 25th percentile values for these four studies have values ranging from somewhat above to somewhat below 12 jig/m 3 . To illustrate, in the Krewski study, the 25th and 10th percentiles of mortality data distribution are 12.0 jig/rn 3 and 10.2 jig/rn 3 . These four studies represent some of the strongest evidence available within the overall body of scientific evidence and three of these studies (Krewski, etal. (2009); Bell, etal. (2008); Zanobetti and Schwartz (2009)) were used as the basis for concentration-response functions in the quantitative risk

assessment. EPA, Quantitative Health Risk Assessment for Particulate Matter (June 2010) ("Risk Assessment"), section 3.3.3.

The epidemioloical evidence further demonstrates the importance of setting the standard no higher than 12 jig/rn in order to provide an adequate margin of safety for at-risk groups. The NAAQS "must protect not only average, healthy individuals, but also 'sensitive citizens' - children, for example, or people with asthma, emphysema, or other conditions rendering them particularly vulnerable to air pollution." American Lung Ass'n v. EPA, 134 F.3d at 390 (citations omitted). Thus, "[i]f a pollutant adversely affects the health of these sensitive individuals, EPA must strengthen the entire national standard." Id. at 389 (citation omitted); see S. Rep. No. 91-1196, 91st Cong., 2d Sess. 410 (1970).

Here, EPA has determined that "large portions of the United States population," including children, whose lungs are still developing, the elderly, and those with pre-existing lung and heart diseases, may be at increased risk of health effects associated with exposure to this pollution. 77 Fed. Reg. at 38,910-11. There are a number of studies in the record that compel the conclusion that a standard of 12 jig/rn 3 or lower is necessary to protect these at-risk groups with an adequate margin of safety. For example, Miller, et al. (2007) identified increases in
PM 25 -related risk of myocardial infarction and coronary revascularization (i.e., angioplasty) with coronary heart disease-related deaths in postmenopausal women who had no previous cardiovascular disease at an annual mean PM 2.5 concentration of 12.9 jig/rn 3 . Other studies of Medicare enrollees identified increases in cardiovascular hospitalizations (Dominici, et al. (2006); Bell, et. al. (2008)) associated with exposures with PM 25 levels in the range of 12.8 jig/rn 3 to 13.3 jig/rn3.Another at-risk group, children, are potentially more susceptible to PM than adults

because children breathe more air per body weight and have a higher lung surface area than adults. 77 Fed. Reg. at 38,910. As a result, children can receive a higher dose of PM 2,5 than adults in the same environmental setting. The Southern California Children's Health Study, a follow-up to the Guaderman, et al. study cited in the court's decision in American Farm Bureau, provided the "strongest evidence" on the susceptibility of children exposed to elevated levels of
PM 2

, 5 at 38,911. The study reported positive associations between long-term exposures to
PM 2,5 and respiratory symptoms and respiratory disease incidence providing evidence that PM2,5 related effects continue into adulthood. Id. PM 25 concentrations ranged from 5.5 to 28.5 tg/m3 with a four-year annual mean of 13.8 jig/rn3.

Infants and fetuses may also be particularly vulnerable to PM exposure. 77 Fed. Reg. at 38,909. Emerging evidence from several studies indicates low birth weight and infant mortality primarily related to respiratory causes during the post-neonatal period where long-term mean
PM 25 concentrations range from 14.9 to 11.9 j.tg/rn 3 . Woodruff, et al. (2008); Liu, etal. (2007); Bell, et al. (2007). Furthermore, the EPA staff noted birth outcome studies that reported positive and statistically significant effects related to aggregate long-term mean PM 2,5 concentrations of approximately 12 jig/rn 3 . EPA, Integrated Science Assessment for Particulate Matter (Final Report) (Dec. 2009) ("Integrated Science Assessment"), Table 7.5.

In addition to the epidemiological evidence, the results of EPA's risk assessment demonstrate the importance of setting the annual standard no higher than 12 jig/rn 3 . The risk assessment provides a basis for estimating on a yearly basis the potential resulting harm to public health from having an inadequately protective NAAQS in place. Using findings of harm to human health in well-accepted epidemiological studies, combined with measured PM 2.5 levels in fifteen urban areas in the U.S. in 2005-07, EPA estimated the number of annual premature deaths from exposure to PM 2

, 5at different concentration levels. See Risk Assessment at 1-6, 2-10-13, 3-25-27, & 3-42-50. Based on the results, a significant number of premature deaths could be averted if EPA were to strengthen the annual standard. For example, if the annual standard was strengthened to 12 jig/rn 3(even without strengthening the 24-hour standard), EPA estimates that 407 premature deaths in New York City, 166 deaths in Los Angeles, and 145 deaths in Philadelphia could be averted yearly compared to exposures at the current 15/35 j.tg/m3 standards. Risk Assessment at E-13 and E-76 (total of deaths averted associated with long-term and short-term exposures).

Although PM 2,5 pollution in the U.S. has decreased since 2007 (the latest year for air quality data used in the Risk Assessment), areas of the country continue to experience PM2,5 concentrations below the level of the current NAAQS but above the levels that EPA staff and CASAC concluded pose a risk to human health. As set forth in affidavits filed in the New York v. Jackson case (D.D.C. No. 12-cv-0243), there are a number of areas, including those discussed in the preceding paragraph, in which PM 2,5 levels are at or below the current annual standard of 15 j.tg/m 3and above annual levels in the range of 11-13 jig/rn 3 . See, Declaration of Karen Magliano (attached hereto as ExhibitA), ¶ 5 (7 percent of California's population, approximately 2.6 million people, are exposed to PM 25 concentrations that exceed the state annual standard of 12 jig/rn 3 but not the federal 15 jig/rn 3 annual standard); Declaration of Ali Mirzakhalili (attached hereto as Exhibit B), ¶ 12 (Delaware residents that work in a neighboringPennsylvania county exposed to levels of PM 2.5 pollution with an annual average of 13.8 .tgIm3

in 2011); Declaration of Robert Sliwinski, P.E. (attached hereto as Exhibit C), ¶ 10 (2011 air quality monitor for New York County (Manhattan) in 2011 exceeded 12 ug/m 3 but was well below 15 .tg/m3).

By contrast, an annual standard of 13 ig/m 3 would not adequately protect public health. EPA staff concluded that an annual standard of 13 p.g/m 3 would place little emphasis on margin of safety considerations given that it would exceed the long-term mean PM 2.5 concentrations reported in several large multicity studies, including the Burnett, et al. (2004) and Bell, et al. (2008) studies. See Policy Assessment at 2-82. Importantly, staff pointed out that there was "nobasis to conclude that these two studies are any more limited or uncertain than the other shortterm studies," noting in particular that Bell, et al. (2008) was a large study of older adults, a susceptible population. j Furthermore, staff observed that a standard at 13 J.Lg/m 3 would also place essentially no weight on more limited evidence of serious effects in susceptible populations (e.g., infant mortality, low birth weight) and would likewise place little to no weight on additional population-level data from a limited number of epidemiological studies. jçj Staff concluded that an annual standard of 13 1g/m 3 "would likely provide less uniform protection across the U.S" than an annual standard in the 11-12 j.tg/m 3 range. See id. at 2-104.

Based on these findings by EPA staff, it is not surprising that the Administrator decided to propose an annual standard of 12 .tg/m 3 , as the interagency documents in the administrative record show. The Proposed Rule's inclusion of 13 .tg/m 3 for the annual standard appears to have originated from the White House Office of Management and Budget ("0MB"), which has no expertise on what level of air pollution poses harm to public health. Interagency documents show that EPA intended to propose an annual primary standard of 12 .tg/m , but changed that to a range of 12-13 ig/m 3in response to 0MB comments. 2Additional revisions were also made to the EPA proposal at OMB's request, including adding more emphasis on the uncertainty of the effects of an 11-12 p.g/m 3 standard and removing a statement regardin the potential link between exposure to PM 25 and reproductive or developmental effects. But, Congress gave the Administrator, not 0MB, the authority to make the judgment on the standard requisite to protect public health. 42 U.S.C. § 7409(b)(2); see also American Farm Bureau, 559 F.3d at 527 (in reviewing EPA's decision on the NAAQS, the court defers to EPA's assessment of scientific data within its technical expertise provided that it examined relevant data and adequately

2 See Attachment to E-mail from Lydia Wegman, EPA to Nathan Frey, 0MB re. Revisions to
PM 25 level section of the PM NAAQS preamble (June 8, 2012, 4:39 PM) (EPA-HQ-OAR-2007- 0492-0454) at 44-48; see also Attachment to E-mail from Lydia Wegman, EPA to Nathan Frey,0MB re. Revisions to AQI section of PM NAAQS preamble (June 8, 2012, 5:02 PM) (EPA-HQOAR-2007-0492-0455) at 4-5 (similar changes to other section of preamble).

See Attachment to Wegman e-mail of 6/8/12 at 4:39 pm at 3 8-39 (showing strikeout of sentence that "Nonetheless, the Administrator believes that this more limited body of evidence provides some support for considering that serious effects may be occurring in a susceptible population at concentrations lower than those associated with effects classified as having a causal or likely causal relationship with long-term PM 2.5 exposures (i.e., mortality, cardiovascular, and respiratory effects).explained itself). As explained above, an annual primary standard of 13 tg/m 3 would not protect

public health with an adequate margin of safety. Indeed, in another interagency document, consistent with staff findings discussed above, EPA warned 0MB that "[ajn annual standard of 13 tg/m 3 (absent a very low 24-hour standard) could raise issues similar to those which resulted in the remand of the 2006 PM 2,5 annual standard." EPA, Draft Proposal for Particulate Matter (PM) National Ambient Air Quality Standards (NAAQS), Briefing for Interagency Review (June 4, 2012) (EPA-HQ-OAR-2007-0492-0451) at 17.

2. EPA Should Adopt A 24-Hour Standard Of 30 pg/rn 3To Protect Against Short-Term Exposure To PM 2.5 Pollution.

EPA acknowledges that there are certain areas of the country, principally the Northwest, in which the annual standard for PM 2

, 5will not be the "controlling" standard to protect public health. 77 Fed. Reg. at 38,943. However, the agency decided not to propose to strengthen the 24-hour standard from its current level of 35 tg/m 3to provide additional protection in these areas. The Attorneys General urge EPA to reconsider that decision in the final rule given the evidence in the record that adverse effects can occur as a result of exposure to PM2,5 concentrations at this level. Moreover, if EPA were to adopt an annual standard of 13 tg/m 3 , it would be arbitrary and capricious for the agency not to strengthen the 24-hour standard to 30 tg/m 3 because the combination of a 13 tg/m 3 annual standard and a 35 jtg/m 3 24-hour standard would not adequately protect the public health.

EPA recognizes that an annual standard intended to serve as the primary means of providing protection from effects associated with both long- and short-term PM 2,5 exposures cannot be expected to offer an adequate margin of safety against the effects of all short-term
PM 2

, 5exposures. 77 Fed Reg. at 38,903; Policy Assessment at 2-92. Both EPA and the Scientific Advisory Committee identified areas of the Northwest, including parts of California, Oregon, and Washington, where this could pose a health problem. These areas historically have had low annual mean PM 2,5 concentrations, but relatively high 24-hour concentrations. Rich Poirot, one of the Advisory Committee members, noted that many of the sites in the Northwest are in fairly deep mountain valley locations with strong winter seasonal early morning peaks under stagnation/inversion conditions. The peaks are often due to wood smoke, other heatingfuel burning and motor vehicle exhaust (diesel and gasoline), which often create extreme shortterm hourly morning peaks during rush hour. Poirot questioned whether these sources of emissions and "their associated carbonaceous aerosols, and extreme temporal exposure regimes are so benign that control efforts should focus instead on the summer ammonium sulfate that tends to dominate chronic exposure in areas which exceed annual standards but not the current 24-hour standard." Samet 9/10/10 letter at A-45.

The epidemiological evidence supports strengthening the 24-hour standard from 35 .tg/m 3 to 30 .tg/m 3 , even if EPA properly adopts an annual standard of 12 .Lg/m 3 , as suggested above. For example, the multi-cit study by Bell, et al. (2008) reported statistically significant adverse effects with an overall 98 percentile value below the level of the current 24-hour standard in conjunction with an overall long-term mean concentration slightly less than 13 p.g/m 3 . Policy Assessment at 2-84; 77 Fed Reg. 38,936-37. This study found increased hospital admissions and emergency department visits at annual mean concentrations of12.9 Lg/m 3 and the 98th percentile value of 34.2 j.tg/m 3

. Integrated Science Assessment,

Table 6.8. In addition, EPA noted that four studies reported positive and statistically significant associations with 981h percentile 24-hour values within a range of 31.2 to 25.8 jig/m 3 and longterm mean concentrations within a range of 12.1 to 8.5 tgIm 3 . 77 Fed. Reg. at 38,937.

If EPA were to adopt an annual standard of 13 j.tg/m 3 , which, as discussed in the previous section, would be contrary to law, the agency would separately violate the statute if it chose to leave the 24-hour standard at 35 jig/rn 3 . The Administrator acknowledged that if she were to adopt an annual standard of 13 j.tg/m 3 instead of 12 tg/m 3 , there may be other areas outside the Northwest, where the 24-hour standard would be the controlling standard. 77 Fed. Reg. at 38,943. EPA staff was more definitive in this regard, stating that adopting an annual standard of 13 tg/m 3"would result in a large number of areas in many geographic areas where the 24-hour standard would likely become the controlling standard." Policy Assessment at 2-104. As a result, EPA staff concluded that consideration of an annual standard level of 13 j.lg/m 3"would have implications for the degree of protection that would need to be provided by the 24-hour standard, such that taken together the suite of PM 2.5 standards would provide appropriate protection from effects on public health related to short-term exposure to PM 2.5 ." 77 Fed. Reg. at 38,935; Policy Assessment at 2-82. To address this concern, EPA staff recommended "that an alternative 24-hour standard level of 30 Lg/m 3. . . in conjunction with an annual standard level of 13 tg/m 3 ." at 38,939; Policy Assessment at 2-102. In explainin its recommendations on the standards (preferably that the Administrator consider a 11-12 .ig/m annual standard combined with a 35 j.tg/m 324-hour standard or, in the alternative, a 13 pg/m 3 annual standard combined with a 30 j.tg/rn 324-hour standard), staff cited "the much stronger body of scientific evidence available in this review supporting a causal relationship between long- and short-term
PM 2.5 exposures and mortality and cardiovascular effects and a likely causal relationship between long- and short-term PM 2.5 exposures and respiratory effects" and "the broad range of long- and short-term exposure studies that reported PM 25 -related effects in areas that would likely have met the current suite of PM 2.5 standards, and. . . available information on the range of concentrations that were most influential in generating the health effect estimates in epidemiological studies." Policy Assessment at 102-03.

In addition to the epiderniological evidence, the importance of strengthening the 24-hour standard under a scenario in which an annual standard of 13 jig/rn 3is chosen is further borne out by the results of EPA's risk assessment. Based on EPA's estimates, a 13/30 j.tg/m 3standardwould be significantly more protective in averting premature deaths from long-term and shortterm exposures than a 13/35 jig/rn 3 standard in twelve of the fifteen cities analyzed: New York City (463 fewer deaths), Los Angeles (409 fewer deaths), Pittsburgh (106 fewer deaths), Phoenix (94 fewer deaths), Philadelphia (91 fewer deaths), Detroit (71 fewer deaths), Fresno (49 fewer deaths), Tacoma (35 fewer deaths), Salt Lake City (31 fewer deaths), Baltimore (22 fewer deaths) and St. Louis (20 fewer deaths). Risk Assessment at E- 13 and E-76. Furthermore, as set forth in affidavits filed in the New York v. Jackson case (D.D.C. No. 12-cv-0243), there are areas that experience average 24-hour levels that would not exceed the current 24-hour standard of 35 jtg/m 3 but exceed a level of 30 jg/m 3 . $ Ex. B, ¶ 12 (Delaware residents that work in neighboring Pennsylvania county exposed to levels of PM 2.5 pollution with daily concentrations averaging 33 j.ig/m 3in 2011); Declaration of Andrew Ginsburg (attached hereto as Exhibit D), 

## ¶ 7 (daily PM 2

, 5concentrations in Portland, Oregon area exceeded 30 jig/rn 3 but not 35 jig/rn3during 2008-10); Declaration of Dr. Matthew Kadlec (attached hereto as Exhibit K), ¶ 9

(residents of five Washington cities experience daily concentrations of 30-35 igIm3).

The recommendation of EPA staff, based on the epidemiological evidence that the 24- hour standard be strengthened to 30 pg/m 3 if an annual standard of 13 jg/m 3is chosen, combined with the results of the risk assessment demonstrating the resulting significant public health protection, show that a 24-hour standard of 30 1g/m 3 is necessary to protect public health with an adequate margin of safety if EPA were to adopt a 13 jtg/m 3 annual standard. The Proposed Rule neither proposes to adopt such a combination of standards nor does the preamble contain any discussion of why the Administrator disagrees with stafVs recommendation and the evidence from the risk assessment.

To comply with the Clean Air Act's requirement that the primary NAAQS be set at a level that protects public health with an adequate margin of safety and the D.C. Circuit's remand order on the 2006 NAAQS, EPA must adopt an annual primary PM 25 standard of 12 .tg/m 3or lower. At the same time, EPA should set the 24-hour standard for PM 25 at 30 tg/m 3 given the evidence in the record that adverse effects can occur as a result of exposure to PM 2 S concentrations at the current level of 35 pg/m 3 . Moreover, if EPA were to adopt an annual standard of 13 ig/m 3 , which the Attorneys General oppose, it would be arbitrary and capricious for the agency not to strengthen the 24-hour standard from 35 Jtg/m 3to 30 ig/m3.

ERIC T. SCHNEIDERMAN Attorney General of New York LEMUEL SROLOVIC Chief, Environmental Protection Bureau

Is! Michael J. Myers

MICHAEL J. MYERS Assistant Attorney General Environmental Protection Bureau The Capitol Albany, NY 12224 (518) 402-2594

LINDA WILSON Staff Scientist Environmental Protection Bureau 125 Broadway New York, NY 10071 (212) 416-8948JOSEPH R. BIDEN, III

Attorney General of Delaware VALERIE M. SATTERFIELD Deputy Attorney General Attorney General's Office Third Floor, 102 W. Water Street Dover, Delaware 19904 (302) 739-4636

GARY KING Attorney General of New Mexico STEPHEN R. FARMS JUDITH ANN MOORE TANNIS L. FOX Assistant Attorneys General Water, Environment, and Util. Division P.O. Box Drawer 1508 Sante Fe, New Mexico 

### (505) 827-6010

PETER F. KILMARTIN Attorney General of Rhode Island GREGORY S. SCHULTZ Assistant Attorneys General Department of Attorney General 150 South Main Providence, Rhode Island 02903 (401) 274-4400, ext. 2400

WILLIAM H. SORRELL Attorney General of Vermont THEA SCHWARTZ Assistant Attorney General Office of the Attorney General 109 State Street Montpelier, VT 05609-1001 (802) 828-3186Attorneys General of New York, Connecticut, Delaware, Maryland, Massachusetts, New Mexico, Rhode Island, Vermont, and Washington

By electronic mail and first class mail

Boris Bershteyn Acting Administrator Office of Information and Regulatory Affairs The White House Office of Management and Budget 725 17th Street, NW Washington, D.C. 20503

Re: National Ambient Air Quality Standards for Particulate Matter

Dear Acting Administrator Bershteyn:

We understand that the Environmental Protection Agency has recently submitted for interagency review a fmal rulemaking package on the National Ambient Air Quality Standards for Particulate Matter to the Office of Information and Regulatory Affairs. Under a consent decree that EPA entered into with our States and several public health organizations, the agency is required to sign the final rule by December 14, 2012. We urge you to support EPA's adoption of annual and daily standards for fine particulate matter that are fully protective of public health, including the health of over 100 million Americans who are most vulnerable to particulate matter pollution. An annual standard for fine particulate matter of no higher than 12 micrograms per cubic meter (p.g/m 3 ) is necessary to protect public health with an adequate margin of safety. In addition, the scientific evidence supports a daily standard of 30 .Lg/m 3 to protect the public against short-term exposures.

Because of the public health imperative for sufficiently protective standards, our States have been advocating for years -- in agency rulemakings and in court -- for EPA to fulfill its duty under the Clean Air Act to issue standards that protect public health with an adequate margin of safety. After EPA rejected the advice of its independent science advisors, the Clean Air Scientific Advisory Committee, in 2006 to strengthen the existing 15 ig/m 3 annual standard for fine particulate matter, we successfully challenged that standard in American Farm Bureau Fed'n v. EPA, and in early 2009, the D.C. Circuit remanded the standard -- which it termed "contrary to law" -- to EPA for reconsideration.

After EPA missed several self-imposed deadlines to issue standards consistent with the D.C. Circuit's decision and then also failed to meet its obligation under the Clean Air Act to timely complete its five-year review, our States filed suit in district court in February 2012 seeking to compel EPA to expeditiously issue particulate matter standards. The case, State of New York, et al. v. Lisa P. Jackson (S.D.N.Y. No. 12- 1064), which was subsequently transferred to federal district court in the District ofColumbia, resulted in a court order requiring EPA to sign the proposed rule by June 14,

2012. The parties subsequently negotiated a settlement resolving the case, memorialized in a consent decree that requires EPA to sign the final rule by December 14, 2012.

It is a central goal of the Clean Air Act "to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population." 42 U.S.C. § 7401(b)(1). A core element of achieving this goal is the Act's requirement that EPA adopt "primary" standards for certain pollutants, such as particulate matter. Critically, the Act requires the standard to be set at a level that protects public health with an "adequate margin of safety."

Fine particulate matter, or particulate matter less than two and a half micrometers in diameter ("PM 2.5 "), fonns predominantly as a result of the combustion of fossil fuel by power plants, motor vehicles, industrial facilities, and residential heating. Because of its microscopic size, fine particulate matter can penetrate deep into the lungs and trigger a wide range of adverse health 

### effects. EPA has linked exposure to fine particulate matter pollution with increased respiratory symptoms (asthma attacks) and disease (acute and chronic bronchitis), decreased lung function, and premature deaths in people with heart or lung disease.

EPA estimates that more than 100 million Americans -- one-third of the nation's population -- have special susceptibility to harm from particulate matter, including children, seniors and people with lung diseases such as asthma. EPA calculated in 2010 that exposure to fine particulate matter pollution at the levels allowed under the 15 jxg/m 3 annual standard could result in roughly 10,000 premature deaths per year in just 15 urban areas in the country. The agency also found that up to half of these premature deaths could be averted if an annual standard of 12 jig/rn 3were adopted.

Although fine particulate matter pollution in the U.S. has decreased since EPA performed these calculations, areas of the country continue to experience fine particulate matter concentrations below the level of the current standards but above the levels that EPA staff and Clean Air Scientific Advisory Committee concluded pose a risk to human health. As set forth in affidavits filed in the New York v. Jackson case, there are a number of areas in our States in which fine particulate matter levels are at or below the current annual standard of 15 jig/rn 3 and above annual levels in the range of 11-13 p.g/m3.

EPA has proposed to strengthen the annual primary standard for PM 2.5 from 15 jig/rn 3 to within a range of 12 jIg/rn 3 -13 p.g/m, 3 and proposed to leave the 24-hour primary standard unchanged at 35 jig/rn 3 . The agency also solicited comments on alternative annual standards down to 11 jig/rn 3 , and on the combination of annual and 24- hour standards.

As explained in detail in the comments of some of our States on the proposed rule (attached for your reference), the adoption of an annual standard of no higher than 12 jtg/m 3 is necessary to protect public health with an adequate margin of safety as required under the Clean Air Act. A primary standard set at no higher than this level iscompelled both by the extensive and overwhelming public health evidence contained in

the record and by EPA's own 2010 quantitative health risk assessment for particulate matter. In the rulemaking, EPA staff concluded that there is now a "stronger and broader body of evidence" than in 2006 that exposure to fine particulate matter causes premature death, breathing problems, and heart disease. The Clean Air Scientific Advisory Committee concurred with EPA staff's finding that the strongest evidence supports a standard in the range of 11-12 .tg/m 3 . In addition, as explained in our attached comments on the proposed rule, the record also supports EPA setting the 24-hour standard for fine particulate matter at 30 ig/m 3 given that adverse public health impacts can occur 

### as a result of exposure at the current level of 35 ig/m3.

Although EPA did alternatively propose to set the annual standard at 13 ig/m3, adopting a standard at this level would not satisfy the agency's obligation under the statute to protect public health with an adequate margin of safety. As explained in the attached comments, EPA staff and the Clean Air Scientific Advisory Committee both cited evidence of harm associated with exposures to concentrations below this level. Therefore, we believe it would be both contrary to the Clean Air Act and to the D.C. Circuit's decision in 

### American Farm Bureau to set the annual standard at 13 Lg/m3.

Finally, EPA's decision should not be delayed on the grounds that more costbenefit analysis on the particulate matter standards is warranted in light of the D.C. Circuit's decision vacating the Cross-State Air Pollution Rule, one of the tools EPA cited for attaining the new particulate matter standards. EPA, our States, and several other parties have petitioned the D.C. Circuit for rehearing of that decision. But more importantly, the Supreme Court has unanimously held that "EPA may not consider implementation costs in setting primary and secondary [standards]." 

### Whitman v. Am. Trucking Ass'ns, 531 U.S. 

### 457, 486 (2001). Instead, EPA must make decisions on the standards 

### solely based on the scientific evidence. 42 U.S.C. § 7409(b)(1).

Every day, particulate matter pollution threatens the health of more than one-third of our nation's population -- particularly our most vulnerable: children, the elderly and the sick. For this reason, we urge you to support EPA's timely adoption of particulate matter standards that fully meet the requirements of the Clean Air Act. Thank you for your attention to this critical matter.ERIC T. SCHNEIDERMAN Attorney General of New York LEMUEL SROLOVIC Chief, Environmental Protection Bureau

MICHAEL J. YER Assistant Attorney General Environmental Protection Bureau The Capitol Albany, NY 12224 (518) 492-2594

GEORGE JEPSEN Attorney General of Connecticut SCOTT N. KOSCHWITZ Assistant Attorney General Office of the Attorney General
55 Elm Street Hartford, CT 06106

JOSEPH R. BIDEN, Ill Attorney General of Delaware VALERIE M. SATTERFIELD Deputy Attorney General Attorney General's Office Third Floor, 102 W. Water Street Dover, Delaware 19904

DOUGLAS F. GANSLER Attorney General of Maryland MARY E. RAIVEL Assistant Attorney General Office of the Attorney General Maryland Department of the Environment 1800 Washington Blvd., S. 6048 Baltimore, MD 21230

MARTHA COAKLEY Attorney General of Massachusetts I. ANDREW GOLDBERG Assistant Attorney General Environmental Protection Division 1 Ashburton Place, Room 1813 Boston, MA 02108 GARY KING Attorney General of New Mexico STEPHEN R. FARRIS TANNIS L. FOX Assistant Attorneys General Water, Environment, and Util. Divis.
P.O. Box Drawer 1508 Sante Fe, NM 87504

PETER F. KILMARTIN Attorney General of Rhode Island MICHAEL RUBIN GREGORY S. SCHULTZ Assistant Attorneys General Department of Attorney General 150 South Main Providence, RI 02903

WILLIAM H. SORRELL Attorney General of Vermont
THEA SCHWARTZ Assistant Attorney General Office of the Attorney General 109 State Street Montpelier, VT 05609-1001

ROB MCKENNA Attorney General of Washington • LESLIE R. SEFFERN Assistant Attorney General Office of the Attorney General P.O. Box 40117 Olympia, WA 98504Enclosure

cc: Lisa P. Jackson, EPA Administrator Nancy Sutley, Chair of Council on Environmental Quality