Opinion ID: 3171722
Heading Depth: 4
Heading Rank: 2

Heading: Feasibility of single-shift sampling

Text: The petitioners next assert that MSHA failed to demonstrate that its move to single-shift sampling is technologically feasible. See NMA Br. 34–39. All of these arguments can be reduced to a simple assertion by the petitioners that single-shift sampling produces inaccurate results and will burden the industry with faulty data suggesting overexposure. We already have rejected the petitioners’ challenge to the extent that it rests on adoption of the Accuracy Criterion and do not repeat that analysis here. With respect to the remainder of the “accuracy”-related challenges to single-shift sampling, MSHA readily acknowledges that there is significant variability in coal dust concentration at places in the mine, and there are measurement differences that occur depending on the placement of the sampling device on the miner’s body, his orientation with respect to dust-producing activities, and the like. If the device encounters different levels of respirable dust, the miner himself encounters variable concentrations of RCD as well.29 29 The National Mining petitioners also claim that, through its adoption of ECVs, MSHA “recognizes the error” in single-shift sampling and attempts to compensate for it with “limited” (continued . . .) 54 Case: 14-11942 Date Filed: 01/25/2016 Page: 55 of 83 There is neither a “perfect” or “true” concentration of dust in a particular area of the mine, nor is there is a perfect sampling method. See Am. Mining Cong., 671 F.2d at 1256 (“[M]easurement error is inherent in all sampling, [so] the very fact that Congress authorized a sampling program indicates that it intended some error to be tolerated in the enforcement of the dust standard.”); see also id. (“Since there is no perfect sampling method, the Secretary has discretion to adopt any sampling method that approximates exposure with reasonable accuracy. The Secretary is not required to impose an arguably superior sampling method as long as the one he imposes is reasonably calculated to prevent excessive exposure to respirable dust.”). MSHA’s rule reflects knowledge of this imperfection, as well as a detailed understanding of improvements—both technological and in the standards for collection by operators—that make single-shift sampling sufficiently “accurate” as to satisfy the statutory standard. See 79 Fed. Reg. at 24,935–36.30 but statistically insufficient “increases in applicable exposure limits.” NMA Br. 38–39. MSHA responds that the ECVs are intended to compensate for inaccuracies inherent in any measurement, regardless of whether it is from a single or multiple shifts or using the older or newer device. See MSHA Br. 50–51. 30 The National Mining petitioners also state that “MSHA dared not base its feasibility analysis on single-shift measurements,” but “tried to support its rule with hypotheticals and analysis of averages that smooth over the variability of underlying single-shift samples. MSHA’s analysis averaged thousands of historical sample results, smoothing out inaccurate peak results.” NMA Br. 37 (emphasis in original) (citations omitted). But this claim is belied by the very analysis that they cite in the preamble, in which MSHA states that, “[a]lthough some commenters” had claimed the feasibility analysis was based exclusively on “historical averages,” it was instead based on “the mean (or average) concentrations, the average deviation of sample (continued . . .) 55 Case: 14-11942 Date Filed: 01/25/2016 Page: 56 of 83 C. Technological Feasibility of Other Major Provisions of the New Dust Rule The petitioners next raise a host of other feasibility challenges. Before addressing each of these, we call to mind the counsel of the Supreme Court when it interpreted a nearly identical provision of the OSH Act. On that occasion, the Supreme Court noted that when a statute commands that the agency consider the feasibility of its regulations, the bar should not be set prohibitively high: “feasible means capable of being done, executed, or effected.” Am. Textile Mfrs. Inst., Inc., v. Donovan, 452 U.S. 490, 508–09, 101 S. Ct. 2478, 2490 (1981) (internal quotation marks omitted). A feasibility determination decidedly does not require the agency to engage in a cost-benefit analysis. Where the statute directs the agency to assure employee safety “to the extent feasible,” “Congress itself defined the basic relationship between costs and benefits, by placing the ‘benefit’ of worker health above all other considerations save those making attainment of this ‘benefit’ unachievable.” See id. at 509, 101 S. Ct. at 2490. Our colleagues in the District of Columbia Circuit similarly have said, [g]iven that feasibility determinations involve complex judgments about science and technology, our standard of review is deferential: concentrations from standards, and the percentage of observations above the standard.” 79 Fed. Reg. at 24,868 (emphasis added). That is, it is not the case that MSHA proceeded with averages to “smooth over,” NMA Br. 37, the variability—MSHA explicitly used averages, along with the magnitude and frequency of variations in its calculations. 56 Case: 14-11942 Date Filed: 01/25/2016 Page: 57 of 83 the agency is not obliged to provide detailed solutions to every engineering problem, but only to give plausible reasons for its belief that the industry will be able to solve those problems in the time remaining. Kennecott Greens Creek Mining Co., 476 F.3d at 957 (internal quotation marks omitted). With this approach in mind, we now turn to the petitioners’ specific objections. 1. Mandatory use of the CPDM Petitioners assert that the transition to the CPDM is not feasible. They contend that MSHA ignored record evidence of the device’s high malfunction rate, failed to consider that its measurement methodology does not protect against inaccuracies due to oversized particles which are not respirable, failed to consider that it is not capable of silica measurement, used inaccurate assumptions to calculate its availability timeline to the industry, and reached incorrect conclusions about the ability of miners to wear the device without impeding their work. Each of these objections was raised before MSHA during the comment period of the rulemaking process, and MSHA responded to them on the merits in the preamble of the final rule. As we have noted earlier, in our review, we do not reweigh the evidence before MSHA; we simply assess whether MSHA’s position, in light of the evidence before it, meets a threshold of reason such that it cannot be deemed arbitrary. See Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43, 103 S. Ct. at 2866 (“The scope of review under the ‘arbitrary and capricious’ standard is narrow and a court 57 Case: 14-11942 Date Filed: 01/25/2016 Page: 58 of 83 is not to substitute its judgment for that of the agency.”); id. at 43, 103 S. Ct. at 2866–67 (noting that the reviewing court must determine whether “the agency . . . examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made” rather than exhibiting “a clear error of judgment” (internal quotation marks omitted)). We also note that, although the petitioners have questioned whether NIOSH had the requisite degree of formal involvement in the rulemaking process required by the statute, see supra section III (evaluating claims that HHS must copromulgate rules), they cannot seriously challenge that MSHA acted consistently with the advice of NIOSH when making its substantive determinations. Indeed, NIOSH was directly involved both in the prior rulemaking on the CPDM technology and the actual, currently marketed commercial CPDM device. See generally 75 Fed. Reg. 17,512; see supra pp. 30–31. Moreover, in the course of the present rulemaking, NIOSH’s comments on the CPDM, included in the record, responded directly to many of the objections raised by the petitioners in their comments on the proposed rule. With this consideration in mind, we now turn to petitioners’ specific objections. 58 Case: 14-11942 Date Filed: 01/25/2016 Page: 59 of 83
The petitioners assert that the devices fail to satisfy the NIOSH Accuracy Criterion more than 40 percent of the time. NIOSH reviewed the data relied on by petitioners on this issue and noted that its source was a single mine operator and that it was based on only 955 individual measurements. By contrast, NIOSH’s own data “analyzed samples that were statistically representative of the nation’s underground coal mining industry” and had been “collected by MSHA inspectors at approximately 20 percent of active mechanized mining units.” 79 Fed. Reg. at 24,863. NIOSH’s comparison of the data sets, accepted by MSHA, notes that “[s]tatistically representative samples are critical for correctly estimating the bias of the CPDM relative to the gravimetric method of the CMDPSU. Bias may not be properly estimated from studies conducted in a limited number of mines or regions, regardless of the number of samples obtained.” Id. Moreover, the objection is based on the errant use of the Accuracy Criterion to evaluate field samples, as opposed to laboratory testing of devices—the purpose for which the Criterion was designed and its use intended. In field sample testing, “[t]he variability reported by the commenter was primarily due to large sample variability, which was due to uncontrolled variables known to exist in field samples, even when two identical samplers were placed side-by-side.” Id. Among the causes of that variability were “significant dust gradients known to exist, 59 Case: 14-11942 Date Filed: 01/25/2016 Page: 60 of 83 sampler inlet location differences, and the nature of mine ventilation.” Id. These are real-time variations in the dust measured that can be controlled in laboratory testing. The error of using field tests to assess device accuracy is laid plain by this data: the complained variations are not evidence of imprecise or unreproducible measurements due to characteristics of the device; they are actual variations in conditions, which are variable inch by inch in a mine. Viewed in this light, the petitioners are objecting to variability inherent in a sampling regime of any kind— a position flatly rejected by a statute that requires a sampling program. MSHA summarized its position on these varying analyses when it concluded, “[t]hrough years of work, NIOSH has demonstrated that the CPDM is an accurate instrument that meets the NIOSH Accuracy Criterion and, therefore, can be used as a compliance instrument.” Id. 31 31 Relatedly, NMA objects that “the CPDMs not only produce results that vary significantly from the current sampler, but they also produce highly variable results from unit to unit.” NMA Br. 41. NMA provides only a general citation, without specificity, to a forty-ninepage analysis by the NMA itself entitled “Analysis of MSHA Coal Dust Sampling Data Base [sic] & The Impact Of The MSHA Proposed Rule,” see I-COMM-58-9. It is not our role to review it independently to determine if anything contained in it supports the stated proposition. This material was in the record before MSHA. As we already have noted, MSHA did not abuse its discretion in relying on NIOSH studies that demonstrate the accuracy of the device under appropriate testing conditions. The petitioners also claim that MSHA attempted to justify the accuracy based on averages of samples taken with the two devices. See NMA Br. at 41–42. But the cited portions of the preamble do not support this statement. Instead, after indicating that the averages from the devices were nearly identical, MSHA continues “that there was no statistically significant difference between the data sets, and that the bias between” the two devices “is zero.” 79 Fed. Reg. at 24,863 (emphasis added). It goes on to explain the mathematical analysis of the data sets in lognormal distribution and notes that “a simple arithmetic average cannot be calculated,” so (continued . . .) 60 Case: 14-11942 Date Filed: 01/25/2016 Page: 61 of 83 b. Assumptions underlying MSHA data and requests to supplement the record before the court In a somewhat related challenge, the petitioners claim that, because of the variability present in sampling, operators would be required to “overengineer” their mines to ensure against sampling readings that, because of measurement inaccuracy, reflect noncompliance. Murray Br. 43. They contend that MSHA’s data is based on a faulty assumption that the mines will only make the reductions necessary to achieve compliance, but will go no further. Accordingly, they contend that the data underlying the feasibility is itself skewed in MSHA’s favor. The petitioners’ analysis is based, in substantial part, on materials that were not before MSHA; they urge us, nevertheless, to take judicial notice of them. “[T]he general rule, applicable across the board to judicial review of administrative action . . . is that the court may not go outside the administrative record.” Najjar v. Ashcroft, 257 F.3d 1262, 1278 (11th Cir. 2001) (internal quotation marks omitted). Accordingly, “[w]hen directly reviewing an agency decision or regulation, a court does not consider any evidence that was not in the record before the agency at the time that it made the decision or promulgated the regulation.” United States v. Guthrie, 50 F.3d 936, 944 (11th Cir. 1995). Though “certain circumstances may “[t]he appropriate method is to average the logarithms of the numbers, followed by untransformation of the logarithmic averages” and so on. Id. 61 Case: 14-11942 Date Filed: 01/25/2016 Page: 62 of 83 justify going beyond the administrative record,” we are “not generally empowered to do so.” See Preserve Endangered Areas of Cobb’s History, Inc. v. United States Army Corps of Eng’rs, 87 F.3d 1242, 1246 (11th Cir. 1996) (internal quotation marks omitted). We have acknowledged that various factors could be considered in determining the propriety of reviewing extra-record material on review of an agency rule, id. at 1246 n.1; in practice, however, we generally have focused pointedly on whether the petitioners have made “a strong showing of bad faith or improper behavior by the agency.” See Alabama-Tombigbee Rivers Coalition v. Kempthorne, 477 F.3d 1250, 1262 (11th Cir. 2007) (internal quotation marks omitted). Because we conclude that the allegations of “bad faith” made by the petitioners in their submissions are not supported,32 we deny the motion for judicial notice and confine our substantive review to the record as it stood before MSHA. 33 32 Murray Energy’s allegation of bad faith is based principally on MSHA’s failure to reference the findings of a 1996 study it commissioned on the development of a fixed-site, machine-mounted sampling device. Murray Energy contends that MSHA made an improper assumption in its calculations, and this 1996 study provides the data that undermines the assumption. Regardless of the value of the data included in that study, Murray Energy’s objection to MSHA’s failure to include it cannot reasonably support expansion of the record here. The assumption to which Murray Energy refers was plainly stated in the materials accompanying the proposed rule as well as the final rule, and there is simply no persuasive justification for allowing the petitioners to rest now on a decades-old study, available to them during notice-and-comment, on which they failed to rely. 33 We note that NMA has made a separate motion for judicial notice of a host of documents. Many of them are legal authorities, and with respect to these we note that the procedural vehicle of a motion is unnecessary; we can and do take account of all relevant authorities in determining the content of the law. NMA also submits, however, substantive evidentiary materials, including a study commissioned for Kentucky’s state-level energy agency, an affidavit filed in support of the brief which provides further analysis of sampling data, and a (continued . . .) 62 Case: 14-11942 Date Filed: 01/25/2016 Page: 63 of 83 We further note, in any event, that MSHA has persuasively demonstrated that the assumption with which the petitioners take issue was made in the context of, and confined to, an entirely separate conclusion—whether the rule will achieve the intended health benefits for miners—not the issue of feasibility on which the petitioners’ argument is based. Accordingly, we see no basis in this objection to find MSHA’s action to have been arbitrary. c. Malfunction rate of the CPDM The petitioners also submit that CPDMs have a high malfunction rate, with 35 percent of units requiring a return to the manufacturer for repair, and 12 percent returned more than once. After examining the data submitted by the petitioners, NIOSH responded that the data lacked “an appropriate experimental protocol to control” critical variables and reflected a misunderstanding by operators of the comment from the Chamber of Commerce in a separate rulemaking proceeding. With respect to these factual materials, NMA asserts that their consideration is necessary to ensure that MSHA considered all relevant material in formulating its rule. See Preserve Endangered Areas of Cobb’s History, Inc. v. United States Army Corps of Eng’rs, 87 F.3d 1242, 1246 (11th Cir. 1996). Whatever the outer limits of this exception to the general rule that review is on the administrative record alone, it is plainly not an invitation to leave the record open indefinitely. The gravamen of NMA’s request is to place before us materials not raised during agency proceedings on the justification that MSHA did not, in a complete notice-and-comment rulemaking, reference, on its own initiative, additional materials that potentially could undermine its position. We do not require MSHA to demonstrate the absence of any additional relevant materials in order to set about the task of regulating required of it by Congress. If this material supported the petitioners’ position below, they had an obligation to present it. 63 Case: 14-11942 Date Filed: 01/25/2016 Page: 64 of 83 import of “error” messages. 79 Fed. Reg. at 24,863–64. MSHA describes NIOSH’s response to the data clearly: [T]hese commenters misunderstood the CPDM error messages received during their testing, believing that the messages indicated failure of the CPDM. The CPDM, as currently programmed, monitors its performance during sampling and registers any status conditions (errors) logged during the sample run. These messages are not indicative of a failure of the CPDM, rather they provide the user with valuable constructive feedback in real-time concerning sample validity. The frequency and type of these error messages are logged during sample collection. They will be used by MSHA to determine whether samples are valid or should be voided. Id. In response, in its brief, NMA states that MSHA’s explanation, that “error” is a status code, rather than an indication of device failure, “does nothing to change the fact that CPDMs appear to malfunction 200 out of every 1,000 times.” NMA Br. 42. But that is exactly what MSHA’s explanation resolves. The error codes do not indicate failure, therefore, failure rates based on error codes are per se invalid. To the extent that NMA is arguing that the devices give the appearance of failure, MSHA’s explanation should suffice to assure operators that they are not, indeed, failing. MSHA further noted that “[g]iven the limited data set, including error messages, from only five mines cited by the commenters as evidence of CPDM failure, both NIOSH and MSHA consider the cited failure rate of 41 errors per 1,000 hours to be invalid. The NIOSH published data remains the most 64 Case: 14-11942 Date Filed: 01/25/2016 Page: 65 of 83 appropriate data set to assess the failure rate of the CPDM.” 79 Fed. Reg. at 24,864. According to that data, the failure rate was lower by “an order of magnitude,” at only 4.75 per 1,000 hours. Id. Moreover, repair rates had improved quarter-to-quarter since the devices were first used in mine settings, and “repair rates are expected to improve in general due to the quality control systems required for certification” of the devices as well as “the actions taken by the manufacturer to address reported field performance.” Id. Before this court, the petitioners simply restate the data that they provided to MSHA in their comments, without addressing any of MSHA’s reasons for rejecting that data in favor of the published results of NIOSH studies. Accordingly, the petitioners ask us to reweigh the evidence, an option that is simply not available to us under our narrow standard of review. The petitioners also contend that later laboratory analysis of samples was a critical “analytical safeguard[] against inaccurate measurements,” including those caused by oversized, non-respirable coal dust. NMA Br. 43. MSHA unapologetically abandoned later analysis in favor of real-time analysis for multiple reasoned bases, including the value of real-time information in employing secondary air-quality controls and the elimination of the possibility of operator tampering. Moreover, the device’s internal controls allow for the same safeguards, in part by issuing status (formerly “error”) codes to indicate oversized particles, 65 Case: 14-11942 Date Filed: 01/25/2016 Page: 66 of 83 etc. The petitioners cite no evidence that these internal device protections against measurement of oversized particles are insufficient to correct the issue they identify. d. Performance at varying temperatures and humidities The petitioners next object that data showed that the CPDM became inaccurate at high temperatures and humidities. MSHA rejected this data. The preamble noted that “[t]he differences” cited by the commenter “are below the minimum detection limit of the commercial CPDM . . . . Therefore, the commenter’s conclusions, which are based on these test results, are inaccurate.” Id. at 24,864. Moreover, it was unclear whether the commenter had used the “user-selected temperature operating range to optimize performance,” and without that information, the validity of the data could not be assessed. Id. Further, the objecting commenter had used an “outdated” Department of Defense testing procedure “not designed to evaluate the accuracy and precision of airborne dust sampling instruments.” Id. Finally, the testing involved talc as a proxy for RCD, which MSHA states is “not representative of respirable coal mine dust.” Id. Again, the petitioners’ brief does not endeavor to undermine MSHA’s reasons for 66 Case: 14-11942 Date Filed: 01/25/2016 Page: 67 of 83 rejecting the data, instead simply citing the data and claiming that MSHA “disregarded [the] evidence.” NMA Br. 41. 34 On all of these questions regarding the implementation of the CPDM device, the record simply does not support the petitioners’ assertion that MSHA “disregarded evidence” in reaching its conclusions about the CPDM’s accuracy. Instead, MSHA’s conclusions, which essentially echo NIOSH’s statistically valid analyses, address head-on the contrary data and explain the flaws that make it less than trustworthy. Its conclusions are supported both by data and by reasoned explanations that the petitioners have failed to challenge in substance. More to the point, the petitioners’ arguments relying on their previously submitted data, with no attempt to address the deficiencies in it identified by MSHA, provide us with no reasoned basis for finding that MSHA acted in excess of its broad statutory discretion. 34 The petitioners also assert failure of the CPDM because of certain electromagnetic interference. However, MSHA asserts that the commercial CPDM satisfies the existing standards for interference set in 30 C.F.R. § 74.7(f). Further, MSHA stated in the preamble that additional standards regarding radio frequency and electro-static discharge interference will be incorporated into part 74, the CPDM has been redesigned to satisfy those new standards, and independent lab testing will confirm it before its use is mandatory. See 79 Fed. Reg. at 24,864– 65. We must conclude that MSHA has taken note of the interference objection and acted within its discretion to address it. 67 Case: 14-11942 Date Filed: 01/25/2016 Page: 68 of 83 e. CPDM as an impediment to miner’s ability to perform work The petitioners also object that use of the device is not feasible because miners cannot wear the device “without impeding their ability to perform their work safely and effectively.” See NMA Br. 45 n.10 (quoting 30 C.F.R. § 74.7(a)). MSHA responds that the petitioners’ analyses are based on the pre-commercial model, and NIOSH’s own analysis of the improved commercial model reaches opposite conclusions, including that the device “adds no more than eight ounces to the total weight carried by the miner.” MSHA Br. 59 (citing 79 Fed. Reg. at 24,866). MSHA also cites planned ergonomic improvement from the manufacturer, including the possible reduction of weight. Id. It also notes that, although the proposed rule required continuous monitoring, the New Dust Rule requires only fifteen samples on consecutive normal production shifts per quarter. Accordingly, the petitioners have not come forward with data that demonstrates a performance issue when the device, in its current commercial iteration, is worn on the more limited schedule prescribed in the New Dust Rule. f. Availability of the CPDM The petitioners next object that the device will not be available in time for implementation of the rule in February 2016. NMA claims that MSHA “entirely failed to consider” the availability issue, and therefore its implementation schedule is arbitrary and capricious. NMA Br. 46 (internal quotation marks omitted). 68 Case: 14-11942 Date Filed: 01/25/2016 Page: 69 of 83 However, again, the record does not support this assertion. MSHA asserts that it developed the eighteen-month phase-in in consultation with the manufacturer, but noted that if MSHA determines that there are logistical or feasibility issues concerning availability of the CPDM, MSHA will publish a notice in the Federal Register to continue to use an approved CMDPSU to conduct quarterly sampling. In addition, assuming no technological issues arise concerning the use and manufacture of CPDMs, and depending on manufacturer projections, if CPDMs are not available in sufficient quantities, MSHA will accept, as good faith evidence of compliance with the final rule, a valid, bona fide, written purchase order with a firm delivery date for the CPDMs. 79 Fed. Reg. at 24,884. Not only has MSHA considered availability and given a timeline based on available evidence, it also already has developed a contingency plan. We have no basis for finding this approach to the question arbitrary. 2. The silica standards35 Shifting their focus from the CPDM, the petitioners challenge whether MSHA has demonstrated the feasibility of what they claim are new silica PEL (permissible exposure limit) and silica-based, reduced RCD limits. See NMA Br. 46. MSHA points out, however, that the new rule does not establish any new silica 35 The regulations use the term “quartz,” although the parties’ briefs generally prefer the term “silica.” According to MSHA’s website, “The terms ‘crystalline silica’ and ‘quartz’ refer to the same thing. Quartz is a natural constituent of the earth’s crust and is not chemically combined with any other substance.” MSHA, MSHA’s Occupational Illness and Injury Prevention Program, Health Topic: Silica Exposure of Surface Coal Miners, http://www.msha.gov/illness_prevention/healthtopics/hhicc01.htm (last visited December 27, 2015). For the sake of consistency, we shall adopt the parties’ terminology. 69 Case: 14-11942 Date Filed: 01/25/2016 Page: 70 of 83 PEL. See 79 Fed. Reg. at 24,866, 24,882. Instead, it states that its new rule merely applies the rule of existing 30 C.F.R. § 70.101, which has consistently limited a miner’s total exposure to respirable silica to 0.1 mg/m3. Under the existing rule, this limit was achieved principally by a requirement that the mine atmosphere contain less than 5% silica (because 5% of 2.0 mg/m3—the existing overall RCD limit—is 0.1 mg/m3). When, under the existing rule, the mine atmosphere contained greater than 5% silica, the overall RCD limit was reduced in proportion to the silica content such that the resulting RCD limit assured a total exposure less than the 0.1 mg/m3 limit. The new rule maintains the identical limit on respirable silica of 0.1 mg/m3, but because of the new RCD limits and their variations, 36 the rule is now phrased in terms of the 0.1 mg/m3 limit rather than the 5% threshold. 37 36 The overall RCD limits imposed by the rule are somewhat generically expressed as 1.5 mg/m3, but are actually variable to a degree based on certain conditions. For example, in the case of a miner who has evidence of CWP, the rules require that operators allow him to work only in a mine atmosphere where the RCD concentration is, beginning August 1, 2016, no higher than 0.5 mg/m3. See 30 C.F.R. § 90.100(b). Likewise, the same lower standard applies, beginning in August 2016, “within 200 feet outby the working faces of each section in the intake airways.” 30 C.F.R. § 70.100(b)(2). 37 The existing rule states: When the respirable dust in the mine atmosphere of the active workings contains more than 5 percent quartz, the operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which each miner in the active workings is exposed at or below a concentration of respirable dust, expressed in milligrams per cubic meter of air as measured with an approved sampling device and in terms of an equivalent concentration determined in accordance with § 70.206 (Approved sampling devices; equivalent concentrations), computed by dividing the percent of quartz into the number 10. (continued . . .) 70 Case: 14-11942 Date Filed: 01/25/2016 Page: 71 of 83 Accordingly, MSHA has a reasoned basis for concluding that the silica standard does not create a new limit. The petitioners also object to the silica standard on feasibility, given that the new CPDM device does not measure silica. However, it is worth emphasizing that neither the newer CPDM nor the prior CMDPSU are capable of silica measurements in RCD. Neither of those devices is designed for that function. Example: The respirable dust associated with a mechanized mining unit or a designated area in a mine contains quartz in the amount of 20%. Therefore, the average concentration of respirable dust in the mine atmosphere associated with that mechanized mining unit or designated area shall be continuously maintained at or below 0.5 milligrams of respirable dust per cubic meter of air (10/20=0.5 mg/m3). 30 C.F.R. § 70.101 (2013). New 30 C.F.R. § 70.101 states: (a) Each operator shall continuously maintain the average concentration of respirable quartz dust in the mine atmosphere during each shift to which each miner in the active workings of each mine is exposed at or below 0.1 mg/m3 (100 micrograms per cubic meter or μg/m3) as measured with an approved sampling device and expressed in terms of an equivalent concentration. (b) When the equivalent concentration of respirable quartz dust exceeds 100 μg/m3, the operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which each miner in the active workings is exposed as measured with an approved sampling device and expressed in terms of an equivalent concentration at or below the applicable dust standard. The applicable dust standard is computed by dividing the percent of quartz into the number 10. The application of this formula shall not result in an applicable dust standard that exceeds the standard established by § 70.100(a). EXAMPLE: Assume the sampled MMU or DA is on a 1.5-mg/m3 dust standard. Suppose a valid representative dust sample with an equivalent concentration of 1.12 mg/m3 contains 12.3% of quartz dust, which corresponds to a quartz concentration of 138 μg/m3. Therefore, the average concentration of respirable dust in the mine atmosphere associated with that MMU or DA shall be maintained on each shift at or below 0.8 mg/m3 (10/12.3% = 0.8 mg/m3). 71 Case: 14-11942 Date Filed: 01/25/2016 Page: 72 of 83 Nevertheless, as the foregoing discussion makes clear, existing rules also set silica limits, enforceable in essentially the same manner. Without a presently approved device capable of direct, real-time measurement of the silica content of RCD, MSHA has elected to reduce the potential health impact of high-silica RCD with a proxy measure: MSHA collects samples itself, with its own equipment, to determine a percentage of silica specific to a particular mine’s atmosphere. When the level of silica in a mine’s atmosphere crosses a threshold set by the rule (indeed, this threshold remains unchanged from prior regulations), MSHA uses a simple calculation that reduces the overall RCD limit below the generally applicable limits in direct proportion to the silica content it has observed. MSHA has identified further, and perhaps more direct, silica limits as a potential subject to be addressed in a future rulemaking. See 79 Fed. Reg. at 24,882. Even if the amendments to the rule were broad enough to give us jurisdiction over a challenge to a procedure that has been in effect for years—a doubtful proposition, at best— the history demonstrates the reasonableness of MSHA’s current approach.38 38 The petitioners fare no better with their objections based on rock dust, which is added to the mine environment and used to control combustibility within the mines. Existing standards limit the RCD and silica content of rock dust, and it is not clear how an operator meeting those standards would have further difficulty imposed in combination with the New Dust Rule. 72 Case: 14-11942 Date Filed: 01/25/2016 Page: 73 of 83 3. The cumulative effect of the New Dust Rule’s changes Finally, the petitioners claim that MSHA failed to conduct a feasibility analysis that examined the cumulative effects of the proposed changes. MSHA responds that it considered extensive data from 2008–09, adjusted to reflect the new, more stringent definition of a normal production shift, in determining the ability of operators to meet the new standards. On the basis of these actual RCD measurements, MSHA concluded that the probability of compliance with the new standards was extremely high, for some areas already at 90%, and even in the very dustiest areas at 65%. It then examined each and every sample in excess of the new standard and determined on a case-by-case basis whether the operator had utilized existing controls, finding that they had not “[i]n each instance.” MSHA Br. 64; see also 79 Fed. Reg. at 24,869 (“MSHA reviewed measurements of the engineering controls in use on the day each sample was collected to assess whether using additional engineering controls would have likely reduced the dust concentration to levels at or below 1.5 mg/m3. Every survey indicated that additional control measures are available that would be likely to reduce the respirable dust concentration to 1.5 mg/m3 or less.” (emphases added)).39 This data analysis is simply not the “brush off,” Murray Energy Br. 39, that the petitioners 39 Moreover, MSHA’s data examined only whether the samples would have satisfied the RCD standard itself, without giving operators the additional benefit of the ECV table and its accounting for a margin of sampling error. See infra p. 78 & note 40. 73 Case: 14-11942 Date Filed: 01/25/2016 Page: 74 of 83 claim. The petitioners merely ask us to reweigh the evidentiary record and credit their submissions that further use of existing engineering controls is not possible. D. Economic Feasibility The petitioners also contend that MSHA did not adequately evaluate the economic feasibility of the New Dust Rule. In their view, MSHA grossly underestimated the costs to the industry of compliance. NMA’s rather cursory discussion of this topic basically suggests that the failure of MSHA’s feasibility analysis is its failure to account for the costs to the industry associated with its projected noncompliance with the new regime, specifically, “extensive revenue losses from delayed production” caused by corrective actions or the necessity of new mine plan approvals, “estimated at least at $1.6 billion per year.” NMA Br. 51. Initially, we note that Murray Energy’s assertion that MSHA’s economic feasibility analysis comprises “just four paragraphs,” Murray Energy Br. 55, ignores MSHA’s more than 200-page separate regulatory economic analysis. See I-REA-16. Moreover, the substance of Murray Energy’s economic feasibility argument is based heavily on evidence submitted to MSHA in response to the proposed rule, specifically, a study by Dr. Robin Cantor that challenged MSHA’s preliminary regulatory economic analysis. See I-COMM-76-1. Murray Energy acknowledges that MSHA “appropriately responded to some of [its] critiques” in its final rule by altering some of its proposals, Murray Energy Br. 55, but believes 74 Case: 14-11942 Date Filed: 01/25/2016 Page: 75 of 83 that MSHA failed to address the most significant critique, which relates to the costs of disruptions to normal operation to implement corrective measures. There can be no question that MSHA was required to evaluate economic feasibility of the New Dust Rule. In our review of this rule’s predecessor, we said so emphatically. Nat’l Mining Ass’n, 153 F.3d at 1269. As the petitioners and MSHA agree, MSHA must “provide a reasonable assessment of the likely range of costs of its standard, and the likely effects of those costs on the industry, so as to demonstrate a reasonable likelihood that those costs will not threaten the existence or the competitive structure of an industry.” Color Pigments Mfrs. Ass’n v. OSHA, 16 F.3d 1157, 1163 (11th Cir. 1994) (emphasis omitted) (internal quotation marks omitted); see also Nat’l Mining Ass’n, 153 F.3d at 1268 & n.5 (noting that rulemaking under the Mine Act requires an economic feasibility analysis analogous to that required in OSHA rulemakings). After reviewing the record, including the extensive economic analysis undertaken by MSHA and the critique of that analysis submitted by the petitioners, we must conclude that MSHA has fulfilled its responsibility and was entitled to make the conclusions that it did. As a preliminary matter, to the extent that the petitioners’ arguments rely on their view that the Rule is not technologically feasible, those arguments are undercut by our earlier conclusion that MSHA is on solid ground with respect to the technological feasibility of operators to achieve compliance. 75 Case: 14-11942 Date Filed: 01/25/2016 Page: 76 of 83 Turning to the matter of actual costs, we think that the record adequately supports MSHA’s determination that the costs of compliance, while not insignificant, can hardly be characterized as so high as to threaten the existence or the competitive structure of the industry. At the outset, as the petitioners admit, MSHA certainly was not unreasonable in discounting the industry’s analysis to the extent that it did not account for the significant changes made by MSHA to the final rule that improved feasibility and reduced the potential for noncompliance: an overall reduction in the number of required samples, an alteration in the RCD limit initially proposed of 1.0 mg/m3 limit to the 1.5 mg/m3 limit actually adopted, and the introduction of “excessive concentration values” or ECVs.40 There remains, no doubt, a difference of opinion between the industry and MSHA about the costs associated with making the adjustments necessary to remedy violations, especially those that require the repair or replacement of faulty equipment. But such 40 Excessive concentration values (ECVs) are the RCD levels, applicable to operator‑collected samples, at which corrective action must be taken. They are greater than the actual RCD limits, and are the result of a calculation by MSHA that grafts on to the RCD standard, to the benefit of operators, an acknowledgement of the possibility of measurement error. As stated in the preamble, MSHA constructed the ECVs to ensure that a citation is issued when the respirable dust standard is exceeded. The ECVs ensure that MSHA is 95 percent confident that the applicable respirable dust standard has been exceeded. Each ECV accounts for the margin of error between the true dust concentration measurement and the observed dust concentration measurement when using the CMDPSU or the CPDM. 79 Fed. Reg. at 24,868; see also supra pp. 6–7 & note 2. 76 Case: 14-11942 Date Filed: 01/25/2016 Page: 77 of 83 differences of opinion are hardly fatal to the Rule. As long as MSHA considers, as it has, the concerns of the industry and has supplied a reasoned view as to why it prefers the view of its own experts, we cannot hold that its decision is arbitrary and capricious. See Fla. Manufactured Hous. Ass’n, Inc. v. Cisneros, 53 F.3d 1565, 1580 (11th Cir. 1995) (holding that an agency “is entitled to rely on the cost estimates calculated by its own engineering staff rather than the figures submitted by the industry’s trade association,” where “our review of the record does not indicate that the agency’s projections are either flawed or unreasonable”). Here, MSHA has reasoned that most such repairs and replacements will be made while the shift continues, during the interim between shifts or during repair shifts. I‑REA-16 at 88–89 (Regulatory Economic Analysis). It also has implicitly recognized that, in the event of a work stoppage to correct a violation, the operator bears the more limited cost of delayed production, but not the loss of its asset, because the coal remains to be mined. Finally, MSHA has noted specifically that, in determining the appropriate time frame for undertaking remedial work, the word “immediate” is somewhat fluid. Certain controls can and should be exercised instantaneously—such as the use of additional ventilation or water, while others can be undertaken but not completed immediately—such as the ordering of a part. In all these matters, MSHA gives due consideration to the good faith of the operator. Id. at 88 (noting that some actions can occur before the next shift, but 77 Case: 14-11942 Date Filed: 01/25/2016 Page: 78 of 83 others, such as those requiring a part to be obtained, will satisfy the “immediate corrective action” requirement with a bona fide purchase order). MSHA has addressed adequately the economic feasibility of the New Dust Rule. E. Other Challenges The petitioners raise several additional brief objections, including a claimed failure of MSHA to consider the “best available evidence” and the experience of other agencies in implementing other health and safety laws. See Mine Act § 101(a)(6)(A), 30 U.S.C. § 811(a)(6)(A). 1. National regulation Murray Energy begins with a best-available-evidence claim that the rule irrationally regulates nationally when the incidence of CWP has lessened nationwide and has spiked only regionally. In its view, the latest scientific evidence supports the view that silica is more toxic than ordinary RCD and that cases of silicosis caused by silica exposure are mischaracterized as rapidly progressing CWP. On this point, the scope of disagreement between the parties is narrower than the petitioners suggest. There is no dispute that silica is a dangerous substance; indeed, the rule (as in prior rules) reduces the maximum RCD limits in proportion to a high presence of silica dust in a particular mine environment. The parties also agree that silica has the potential to advance the progression of CWP 78 Case: 14-11942 Date Filed: 01/25/2016 Page: 79 of 83 and to cause its own serious lung disease, silicosis. The petitioners contend, however, that the evidence demonstrates that the rise in CWP upon which the New Dust Rule is predicated is really a rise in silicosis, or perhaps a rise in a subtype of CWP in which silica is the principal factor. They claim that MSHA ignored the scientific evidence on this point. On the contrary, MSHA devotes several pages of the preamble to addressing objections regarding RCD concentration as a predictor of CWP rates, see 79 Fed. Reg. at 24,823, localized spikes in CWP rates, id. at 24,827–28, effects of silica on CWP and data regarding silicosis, id. at 24,828–29, and other factors influencing CWP rates, such as the variable carbon content of coal at certain mines, id. at 24,829. After reviewing the evidence cited by the petitioners as well as other evidence, MSHA concludes: Based on all of the available evidence, MSHA believes that respirable coal mine dust has a fibrogenic effect on the development of CWP in coal miners independent of the quartz or silica content of the coal. High silica content may accelerate the progression of CWP to PMF [progressive massive fibrosis], the most severe form of CWP, but there is no evidence to suggest that the presence of silica is a necessary condition for CWP, PMF, severe emphysema, or [non‑malignant respiratory disease] mortality. Id. at 24,829–30. The record contains a wealth of not-always consistent research on this issue, and MSHA does not cite each paper or author on which the petitioners relied in their responses. Nevertheless, MSHA acknowledged the petitioners’ concern and their data, presented contrary evidence that supported 79 Case: 14-11942 Date Filed: 01/25/2016 Page: 80 of 83 MSHA’s position, and reached a conclusion about the appropriate course based on that evidence. The petitioners submit that MSHA merely rejected strawmen and failed to address its objections that CWP was declining and silicosis was, as a matter of epidemiology, the likelier culprit for present-day areas of concern. We cannot accept the petitioners’ contentions for two reasons: First, MSHA’s conclusion that CWP rates can improve further with further reductions to the RCD limits is a reasoned one, supported by the historical record and the data before MSHA in the present rulemaking. Accordingly, the petitioners’ assertion that “CWP is declining under the current system, i.e., the system is working,” Murray Energy Br. 64, even if true, is irrelevant where CWP incidence has not been reduced to zero and MSHA has not completely fulfilled its mission to “protect the health . . . of the Nation’s coal or other miners.” Mine Act § 2(g), 30 U.S.C. § 801(g); see also id. § 2(c), 30 U.S.C. § 801(c) (noting the urgent need to “prevent,” not merely reduce the incidence of, “occupational diseases originating in . . . mines”); id. § 101(a)(6)(A), 30 U.S.C. § 811(a)(6)(A) (“The Secretary, in promulgating mandatory standards dealing with toxic materials or harmful physical agents under this subsection, shall set standards which most adequately assure on the basis of the best available evidence that no miner will suffer material impairment of health or functional 80 Case: 14-11942 Date Filed: 01/25/2016 Page: 81 of 83 capacity even if such miner has regular exposure to the hazards dealt with by such standard for the period of his working life.” (emphasis added)). Secondly, MSHA’s evaluation of the silica question is a paradigmatic example of an agency “evaluating scientific data within its technical expertise” to which “an extreme degree of deference to the agency” is appropriate. Kennecott Greens Creek Mining Co., 476 F.3d at 954–55. Moreover, to the extent the petitioners’ objection is focused on a regulatory need to address silicosis, not only do we defer to an agency’s determination of regulatory priorities, we must acknowledge that MSHA has identified silica content in RCD as a subject for potential future rulemaking. See id. at 954 (finding it reasonable for the agency to regulate in an area of known risks and continue researching further potential risks). 2. Use of respirators to achieve air quality standards Next, the petitioners contend that MSHA should have accepted their proposal to allow operators to satisfy the RCD standards with the use of secondary personal controls—principally, personal respirators. MSHA counters that the statute does not permit this approach. We agree; the statute is unambiguous on this point: “Use of respirators shall not be substituted for environmental control measures in the active workings.” Mine Act § 202(h), 30 U.S.C. § 842(h). The petitioners nevertheless claim that the statute, which only prohibits “substitut[ion],” allows respirators to be used in conjunction with other controls, as 81 Case: 14-11942 Date Filed: 01/25/2016 Page: 82 of 83 a secondary measure. MSHA does not dispute this proposition, and, indeed, acknowledges that the New Dust Rule requires operators to provide respirators under certain conditions, specifically, where an operator-collected sample exceeds the ECV. See 30 C.F.R. §§ 70.208(e)(1), 72.700. Therefore, nothing in the rule prevents the industry from employing respirators as part of a hierarchy of controls that should be used together as “the best way to ensure miner safety and health,” NMA Br. 58. MSHA has interpreted the statutory command correctly, however, in requiring that mine air quality meet the regulatory standard without resort to a personal control.