1 TSRIA Document 2.1: Applying the New Standards in EPA’s Handout Results in a Design Value Below the SO 2 NAAQS

At the February 27, 2014, meeting with TSRI A, EPA distributed a handout with data quality standards (EPA Handout or the Handout) 1 that EPA claimed validated the design value of 79 ppb upon which it based the nonattainment desi gnation for a portion of Yellowstone County (the Designation). However, correctly applying the standards from the EPA Handout results in a design value for the Coburn Road monitor of 61 2 and thus invalidates the Designation.

The EPA Handout outlines a “weight of eviden ce” standard for data quality assurance (QA). The Handout also sets forth a validati on template with monitoring QA standards for Critical Criteria and Operational Criteria (New Standards). EPA stated that these New Standards governed its analysis of the Coburn Road mon itoring data and documented QA failures. EPA
asserted that when the New Standards were applied to the 2010 data, Critical Criteria QA requirements were met and thus rendered other identified QA failures insufficient to invalidate the data from use for a NAAQS Designation. 3

However, there are two critical errors in EPA’s application of the New Standards and reasoning.

 First, EPA inaccurately applied the New St andards and thus failed to discern that there are failures in the Critical Criteria QA th at invalidate several cri tical data points.

 Second, EPA has not met the burden of proof set forth in the New Standards that require data subject to identified Critical Criteria and Operational Criteria QA failures to be invalidated unless EPA provides othe r compelling evidence that demonstrates
that the data are valid. 4

1 See TSRIA Document 2.4: EPA Meeting Handout. The EPA Handout contains data quality standards that were not in effect when the data were gathered and on which Petitioners did not have the opportunity to comment. However, application of these new standards, upon which it was impracticable to raise objections during the public comment period, actually contradicts the principal grounds on which the Designation is based and therefore is of
central relevance to the outcome of the rule. See 42 U.S.C. § 7607(d)(7)(B) (standard for petition for reconsideration). EPA quietly incorporated the new “weigh t of evidence” standard into Appendix A of 40 C.F.R. Part 58 as part of revisions to the PM 2.5 NAAQS, which only became effe ctive in March of 2013. See EPA, National Ambient Air Quality Standards for Particulate Matter, 78 Fed. Reg. 3086 (Jan. 15, 2013). The validation template and associated text on the Handout are from the EPA Quality Assurance Handbook for Air Pollution Measurement Systems (EPA QA Handbook) § 17.3.3, issued in May of 2013.

2 See TSRIA Document 2.2: Attachment A for an explanation of the new design value calculation.

3 TSRIA does not concede that the New Standards may be legitimately applied to data gathered and quality assured before the standards were promulgated and on which TSRIA could not practicably comment. EPA’s use of the New Standards denied TSRIA and other stakeholders the opportunity to comment on whether EPA appropriately applied
the New Standards and whether the New Standards themselves are appropriate for the data in question, which were
collected and submitted before the New Standards were effective.

4 Previous data quality standards establish a simila r burden of proof for data with QA failures. See, e.g. , EPA Quality Assurance Handbook for Air Pollution Measuremen t Systems (EPA QA Handbook) § 17.3.3, issued in
December of 2008.2 Correct application of the New Standards to the Coburn Road m onitoring data with documented QA failures invalidates numerous data point s, bringing the design value below the SO 2 NAAQS and nullifying the Designation. 5

A. When correctly applied the New Standards invalidate data with Critical Criteria
failures.

As more fully explained in Attachment B, EPA failed to fully apply the New Standards before using them to justify reliance on data w ith documented Critical Criteria QA failures. Page two of the EPA Handout provides the minimum QA requirements for the Critical Criteria “Zero/Span” and “One-Point QC” checks that EPA relied on to dismiss other QA failures. According to the EPA Handout, for the zero/span portion of these Critical Criteria checks, the analyzer’s zero response must not exceed +/- 1.5 ppb, and the zero/span check must be conducted every two weeks. However, four of th e critical high readings in 2010 fail to meet these criteria, as explained in Attachment B. 6 EPA emphasizes in its own Handout that
“observations that do not meet each and ever y criterion on the cri tical criteria table should be invalidated unless there are compelling r eason and justificatio n for not doing so.” 7 Invalidating these high readings from 2010 and using data from 2012, as is allowed by EPA, 8 brings the design value to within 0.18 ppb of the 75 ppb standard, an amount well below the 1 ppb resolution specification of th e Coburn Road monitor. See Attachment B for a more thorough and technical analysis.

B. EPA must also invalidate data with Op erational Criteria failures because EPA
has not demonstrated otherwise.

EPA’s articulated grounds for reliance on the 2010 data, despite numerous documented QA failures, do not satisfy its obligation to demonstr ate that data are not “s uspect” before relying on them in a regulatory context, as set forth in both the New Standards and previous standards. 9
Because EPA has not met this burden, the data in Chart 5 with QA failures 10 must be invalidated.
In addition to the documented Critical Criteria failures set forth in the previous section and Attachment B—which render data invalid until proven otherwise 11 —the EPA Handout emphasizes that QA failures for “Operational Crit eria” also render data “suspect unless other quality control information demonstrates otherwise.” 12 The “Operational Criteria” portion of the

5 Regardless of which QA standards are applied, the burden is on EPA to justify using data that do not meet Montana QAPP or EPA QA Handbook standards. See, e.g. , 40 C.F.R. § 58, App. A, § 1 (prior to March 18, 2013); EPA QA Handbook December 2008 , § 17.3.3. TSRIA continues to assert that the 1996 Montana QAPP was the legal document in effect when the data used for the De signation were gathered and submitted. Thus the MDEQ QAPP contains “applicable standards specifications” that must be complied with per 40 C.F.R. § 58, App. A § 2.1. If the applicable standards specifications of the MDEQ QA PP are not complied with, the burden is on EPA to show the data meet the “more stringent” QA st andards for use in a NAAQS designation.

6 See TSRIA Document 2.3: Attachment B, which also explains that the zero/span check invalidates another reading in 2013 and identifies other data of concern in the hours just preceding or following automated zero/span checks.

7 EPA Handout, quoted from EPA QA Handbook, 2013 § 17.3.3 (emphasis added by EPA).

8 See EPA, RTC at 52.

9 EPA Handout/EPA QA Handbook, 2013 § 17.3.3 (Validation Template for Operational Evaluations).

10 See TSRIA Presentation to EPA on February 27, 2014, Chart 5 (revised 2/24/14).

11 Id . (Validation Template for Critical Criteria).

12 Id . (Validation Template for Operational Evaluations) (emphasis added).3 data validation table in the EPA Handout is an abridged version. The full table also includes
criteria for calibration results a nd calibration gas standa rds, in addition to other data quality indicators. These other Operational Criteria, especially relating to instrument calibration, 13 are important QA measures that must reasonably be part of the “more stringent” QA standards 14
necessary for data supporting a NAAQS designation.

Because this is a NAAQS desi gnation, EPA must apply “mor e stringent” QA standards to the data points with documented Operational Crit eria failures. Since EPA has provided no other consistently credible quality control informati on that proves the validity, EPA must invalidate the data points with documented QA failures. As outlined in Chart 5, many of the high readings at Coburn Road suffer from numerous Operationa l Criteria failures. EPA has not made the demonstration necessary to rely on these data in the face of the QA failings, while TSRIA has provided significant data and analyses that demo nstrate the data are unreliable, inconsistent, unrepresentative, and invalid. In addition, neither EPA nor MDEQ have adequately investigated, mitigated, or justified the reasons for not meeting these criteria as required by the EPA
Handout. 15 In total, the Critical Cr iteria and Operational Criteri a QA failures invalidate enough data that the resulting design value of 61 does not support the Designation.

C. EPA’s “moving target” assumptions do not support use of the data with QA
failures.

Because of the “more stringent” QA sta ndard required for a NAAQS designation, 16 the QA failures that have been documented place a high burden on EPA to demonstrate why it will not invalidate these data. EPA has never presented credible data quality control information that indicates the QA failures should not invalidate the data. To the cont rary, since rejecting the State of Montana’s initial designation and repeated requests to avoi d using the unrepresentative 2010 data, EPA has relied on a “moving target” 17 of unsupported assumptions:

 First, EPA assumed the 2010 data with documented QA failures were representative. 18

o TSRIA has demonstrated both that th e 2010 data suffer from an unusually high number of QA failures in comparison to subsequent ye ars and that the 2010 data are unrepresentative of emission trends, existing SO 2 controls, and the current air quality.

13 See TSRIA Document 2.5: Full 2013 Validation Template.

14 EPA, Quality Assurance Handbook for Air Pollution M easurement Systems, Vol. II (Ambient Air Quality Monitoring Program), EPA-454/B-13-003, May 2013, at § 1.3.1.

15 EPA Handout/EPA QA Handbook, 2013 § 17.3.3 (Validat ion Template for Operational Evaluations and Critical Criteria).

16 EPA QA Handbook § 1.3.1.

17 See North Carolina v. EPA , 531 F.3d 896, 927 (D.C. Cir. 2008) (granting Minneso ta Power’s petition because EPA failed to adequately address claims of technical errors and used a “moving target” for data determinations in its response to comments and rejection of the petition for reconsideration).

18 See EPA, TSD at 10.4  Second, EPA relied on audits which it claimed outweighed any QA failures. 19

o TSRIA demonstrated that the audits al so suffer from QA failures, which EPA should have further investigat ed before relying on them. 20

 Third, EPA relied on Critical Criteria and a new “weight of evidence” standard which it claimed outweighed all other QA failures.

o TSRIA has identified four critical data points in 2010 that fail to meet the Critical Criteria, and EPA has failed to meet the weight of evidence standard and the Critical Criteria and Opera tional Criteria sta ndards in the EPA Handout to support use of data with QA failures. 21

The record before EPA demonstrates that th e QA failures during 2010 and the unreliable nature of the monitoring data do not provide an ad equate foundation for a NAAQS designation. EPA, consistent with regulatory requirements, should invalidate the data and repeal the Designation.

19 See EPA, RTC at 46.

20 See TSRIA Presentation titled EPA Additional Information Re quests, Revised Chart 5; Attachment to Comments from Montana Chemical & Sulphur Company at 14-25 Docket EPA-HQ-OAR-2012-0233-0298; TSRIA Comments at 13-16, Docket EPA-HQ-OAR-2012-0233-0285.

21 See Attachment B and discussion above.