Opinion for the Court filed PER CURIAM.
In this opinion, we consider several challenges to the Environmental Protection Agency’s most recent revisions to the primary and secondary National Ambient Air Quality Standards for ozone. For the reasons given below, we deny the petitions, except with respect to the secondary ozone standard, which we remand for reconsideration.
I.
The Clean Air Act directs EPA to establish and periodically review and revise primary and secondary National Ambient Air Quality Standards (“NAAQS”) for certain pollutants the “emissions of which ... cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare.” 42 U.S.C. § 7408(a)(1)(A). Under section 109(b)(1), primary NAAQS are to be set at levels “the attainment and maintenance of which in the judgment of the Administrator, ... allowing an adequate margin of safety, are requisite to protect the public health.” Id. § 7409(b)(1). Under section 109(b)(2), secondary NAAQS “shall specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator ... is requisite to protect the public welfare from any known or anticipated adverse effects.” Id. § 7409(b)(2). The Act provides that the public welfare protected by secondary NAAQS includes “effects on soils, water, crops, vegetation, manmade materials, animals, wildlife, weather, visibility, and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.” Id. § 7602(h).
“Once EPA establishes NAAQS for a particular pollutant, the standards become the centerpiece of a complex statutory regime aimed at reducing the pollutant’s atmospheric concentration.” American Trucking Ass’ns v. EPA (“ATA III”),
These consolidated cases concern the NAAQS for ozone (03). Ozone is a colorless, odorless gas that is not a direct product of human activity but instead forms when other atmospheric pollutants react in the presence of sunlight. ATA III,
EPA last revised the ozone NAAQS in 1997, instituting an “8-hour” primary standard — based on the annual fourth-highest daily maximum 8-hour average ozone concentration — of 0.08 parts per million. National Ambient Air Quality Standards for Ozone (“1997 Final Rule”), 62 Fed.Reg. 38,856, 38,873 (July 18, 1997). EPA also set the secondary NAAQS to be identical to this primairy standard in both form (measured over an 8-hour period) and level (0.08 ppm). Id. at 38,877-78. In American Trucking Associations v. EPA,
EPA initiated the cuxrent review of the ozone NAAQS in 2000. Proceeding under a schedule adopted by consent decree, and after receiving significant public comment on proposed changes, EPA issued revised primary and secondary standards on March 27, 2008. National Ambient Air Quality Standards for Ozone (“2008 Final Rule”), 73 Fed.Reg. 16,436 (Mar. 27, 2008). In reaching its final decision, EPA examined “the entire body of evidence relevant to examining associations between exposure to ambient 03 and a broad range of health endpoints.” Id. at 16,439. Of particular relevance here, EPA emphasized new clinical studies, including human exposure studies, showing respiratory effects at ozone levels below 0.08 ppm. Id. at 16,-449-50, 16,470-71. EPA also cited new epidemiological evidence suggesting associations between “serious morbidity outcomes” and ozone exposure at levels below 0.08 ppm, as well as risk assessments estimating the effects of various levels of ozone on the population. Id. at 16,446, 16,450-51, 16,471-72. On the basis of this evidence, EPA concluded that the existing 0.08 ppm primary standard was not requisite to protect the public health with an adequate margin of safety. Id. at 16,470-71.
Assessing the proper level for a revised standard, EPA found that a level just below 0.08 ppm would be inappropriate because “such a level would not be appreciably below the level in controlled human exposure studies at which adverse effects have been demonstrated.” Id. at 16,482. Although acknowledging that CASAC had
EPA also determined that the secondary standard should be revised to be identical to the new primary standard. Id. at 16,-500. Noting new evidence that had become available since the last review, EPA found that the ozone level of the existing secondary standard would cause significant effects on vegetation and sensitive ecosystems. Id. at 16,496-97. EPA acknowledged CASAC’s recommendation that a revised secondary standard should measure ' ozone exposure cumulatively over a seasonal period, rather than the 8-hour period of the primary standard. Id. at 16,498-500. EPA agreed with CASAC that “a cumulative, seasonal standard is the most biologically relevant way to relate exposure to plant growth response.” Id. at 16,500. Nonetheless, conducting a comparison between the revised primary standard and a range of proposed levels for a cumulative, seasonal standard, EPA found “significant overlap between the revised 8-hour primary standard and selected levels of the [seasonal] standard form being considered.” Id. at 16,499. Although recognizing that “there would be the potential for not providing the appropriate degree of protection for vegetation in areas with air quality distributions that result in a high cumulative, seasonal exposure but do not result in high 8-hour average exposures,” the agency determined that “establishing a new secondary standard with a cumulative, seasonal form at this time would result in uncertain benefits beyond those afforded by the revised primary standard and therefore may be more than necessary to provide the requisite degree of protection.” Id. at 16,500. EPA therefore concluded that the revised primary standard “would be sufficient to protect public welfare from known or anticipated adverse effects, and ... that an alternative cumulative, seasonal standard is [not] needed to provide this degree of protection.” Id.
Challenging the revised primary and secondary NAAQS, various parties, including several states, the District of Columbia, New York City, and several industry, environmental, and public health groups, filed these petitions for review. We then granted EPA’s unopposed motion to hold these cases in abeyance to allow the agency to review the 2008 revisions and determine whether they should be reconsidered. In September 2011, EPA indicated that it was withdrawing its reconsideration proceedings and would instead be completing the reconsideration in conjunction with the next periodic review. Several parties filed
We now confront the parties’ competing petitions for review. One set of petitioners — comprising several states, the District of Columbia, New York City, and a number of environmental and public health groups — thinks the primary and secondary NAAQS are not protective enough, while the other set — comprising the state of Mississippi and several industry groups— thinks they are too protective.
This opinion considers each of these claims in turn. We reject Mississippi and the industry groups’ challenge to the primary and secondary standards in Part II. We explain our denial of the governmental and environmental petitions with respect to the primary standard in Part III and our grant of these petitions with respect to the secondary standard in Part IV.
In considering challenges to NAAQS, “we apply the same highly deferential standard of review that we use under the Administrative Procedure Act.” ATA III,
II.
Mississippi and the industry petitioners (collectively “Mississippi”) challenge EPA’s threshold decision to revise the primary NAAQS level. According to Mississippi, several aspects of EPA’s decision were arbitrary, including its allegedly unsupported finding that the revised NAAQS would provide increased protection; its failure to compare the 2008 risk assessment with the 1997 risk assessment; and the allegedly inadequate and distorted science on which the agency relied. We reject these arguments. Mississippi also claims the secondary NAAQS is improper because it tracks the primary NAAQS, which Mississippi believes is unlawful, but this argument falls as collateral damage from our rejection of Mississippi’s challenge to the primary NAAQS.
A.
The Clean Air Act requires EPA to set primary NAAQS that are “requisite” to protect the public health with an adequate margin of safety. 42 U.S.C. § 7409(b)(1). “Requisite” means the NAAQS must be “sufficient, but not more than necessary.” Whitman,
The force of Mississippi’s position, generated by the Whitman Court’s malleable definition of “requisite,” assumes only one
Determining what is “requisite” to protect the “public health” with an “adequate” margin of safety may indeed require a contextual assessment of acceptable risk. See Whitman,
Mississippi argues at length that EPA should have compared the evidence available in 2008 to the evidence available in 1997 — in particular, the clinical, epidemiological, and toxicological studies, risk assessments, and EPA’s protocol for sensitive populations. We need not respond point by point; suffice to say that EPA reasonably explained how the scientific evidence had in fact changed since the 1997 review. To name just one example, whereas in reviewing EPA’s 1997 NAAQSsetting we emphasized “the absence of any human clinical studies at ozone concentrations below 0.08,” ATA III,
B.
Mississippi looses the rest of its arrows at the evidence on which EPA relied, although in doing so, Mississippi again showcases its apparent preference for exuberance over precision. Ultimately, Mississippi’s arguments that the 2008 science added nothing new to the 1997 NAAQS conversation and that EPA misrepresented the science on which it relied are largely dependent on the conceptual error that EPA is somehow bound by the 1997 NAAQS and on the legal error that it is our job to “weigh the evidence anew.” American Farm Bureau,
1.
The 1997 standard was “set at a level of 0.08 ppm, which is equivalent to 0.084 ppm using the standard rounding conventions.” 2008 Final Rule, 73 Fed.Reg. at 16,437. By framing the issue in terms of EPA’s decision to lower the NAAQS level below 0.080 ppm, Mississippi fails to capture the full significance of the 2008 NAAQS revision.
In any event, after reviewing the record, we think it quite clear EPA’s rejection of the 1997 NAAQS was proper. EPA relied on a broad array of scientific studies, quantified models, and input from CASAC, EPA staff, and commenters, and it considered not only what was known, but also what was not known. See, e.g., 2008 Final Rule, 73 Fed.Reg. at 16,438-40. It then evaluated the evidence as a whole through an “integrative synthesis,” what it called a “weight of evidence approach.” Id. at 16,439, 16,479. And appropriately so: one type of study might be useful for interpreting ambivalent results from another type, see Ethyl Corp. v. EPA, 541
Reasonable people might disagree with EPA’s interpretations of the scientific evidence, but any such disagreements must come from those who are qualified to evaluate the science, not us. We are satisfied that EPA’s interpretations are permissible, and that is enough. Indeed, CASAC unanimously concluded that “[t]here is no scientific justification for retaining the current primary 8-hr NAAQS of 0.08 parts per million,” that the primary NAAQS “needs to be substantially reduced to protect human health,” and that the primary NAAQS should be set at a level somewhere 0.060 and 0.070 ppm. Letter from Dr. Rogene Henderson, CASAC Chair, to Stephen L. Johnson, EPA Administrator (“Oct.2006 CASAC Letter”), at 1-2 (Oct. 24, 2006), EPA-CASAC-07-001. If, as we have explained, EPA may give “significant weight” to propositions about the appropriate NAAQS level implicitly accepted by otherwise-disagreeing CASAC members, see ATA III,
And given the reasonableness of EPA’s interpretation of the science, its determination that the 1997 NAAQS was insufficiently protective of public health follows as a matter of course. EPA concluded sensitive populations like asthmatics are affected by ozone in a more severe way and at lower levels than are healthy individuals and that ozone-related health effects might be adverse for sensitive individuals though comparable effects would not be considered adverse for healthy individuals — conclusions Mississippi does not challenge. See 2008 Final Rule,
Mississippi also contends that section 108(a)(2) of the Clean Air Act, 42 U.S.C. § 7408(a)(2), requires EPA “to consider and rely upon all scientific information that is capable of being put to use and serviceable for [identifying the effect that a given pollutant has on public health and welfare] and that is free from error (accurate).” Mississippi’s Br. 47. This requirement, Mississippi explains, incorporates information standards under the Information Quality Act (“IQA”), Pub.L. No. 106-554, sec. 1(a)(3), § 515, 114 Stat. 2763, 2763A-153 to 154 (2000) (H.R.5658) (codified at 44 U.S.C. § 3516 note). According to Mississippi (as we understand its argument), EPA violated both the Clean Air Act and the IQA by inaccurately characterizing some studies and by relying on other, flawed studies. These arguments are difficult to parse because they fill two roles in Mississippi’s shadow play: reinforcing the implied point that the available evidence did not support EPA’s decision to revise the NAAQS level and unmasking a violation of the Clean Air Act’s procedural requirements. Having already discussed the reasonableness of EPA’s threshold decision to revise the NAAQS, we now consider only Mississippi’s suggestion that EPA violated the Clean Air Act’s and the IQA’s procedural standards and that these violations independently render EPA’s NAAQS determination unlawful.
The Clean Air Act implicitly divides the NAAQS review process into three stages. First, members of the scientific community publish studies, which may be more or less flawed. Second, EPA must issue and periodically revise air quality criteria that “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air, in varying quantities.” 42 U.S.C. §§ 7408(a)(2), 7409(d). Finally, EPA must “base[ ]” its NAAQS determinations on the criteria. 42 U.S.C. § 7409(b)(1). From start to finish, this system is vulnerable to error. In particular, even if the foundational scientific studies are not flawed in any material way, transmission errors may nevertheless occur when EPA drafts the criteria or when it subsequently decides what NAAQS to set. Mississippi’s point appears to be that the Clean Air Act and the IQA impose safeguards to ensure accuracy throughout this entire process. While that may be a fair characterization, it overstates the practical effect of the statutory schemes.
First, though the Clean Air Act requires the air quality criteria to “accurately reflect” the scientific evidence, that requirement says nothing about the accuracy of the science itself or the precision of the relationship between the criteria and EPA’s NAAQS decision. The criteria, which are neither “standards” nor “guidelines,” simply “provide the scientific basis for promulgation of air quality standards.” Lead Industries Ass’n,
Second, Mississippi fails to show the IQA is an independent measure of EPA’s NAAQS decision. The IQA requires the Director of the Office of Management and Budget to provide “policy and procedural guidance” to “ensur[e] and maximiz[e] the quality, objectivity, utility, and integrity of information ... disseminated by Federal agencies.” 44 U.S.C. § 3516 note. OMB, in turn, issued flexible, “generic” guidelines that it recognized “cannot be implemented in the same way by each agency.” Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Republication, 67 Fed.Reg. 8,452, 8,452-53 (Feb. 22, 2002). EPA’s implementing guidelines, meanwhile, purport to provide only “nonbinding policy and procedural guidance.” EPA, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency 4 (2002). Mississippi points to nothing indicating that any part of this scheme committed EPA to having done things differently. See American Petroleum Institute v. EPA,
Measuring Mississippi’s challenge to EPA’s use of the scientific evidence against the agency’s legal obligations, we see nothing to suggest EPA acted improperly, particularly given our approval of its ultimate decision to revise the NAAQS. To start, Mississippi’s challenge to EPA’s use of the Adams studies—a set of controlled human exposure studies that played a relatively significant role in the NAAQS review process—is nothing more than a claim that EPA did wrong by disagreeing with Adams’s interpretation of his data. (Although Adams concluded his 2006 study did not show statistically significant lung function decrements at the 0.06 ppm ozone exposure level, EPA explained that it believed a different statistical model would more directly address the precise question with which it was concerned— namely, the effects of prolonged ozone exposure versus exposure to filtered air— and that application of this model yielded statistically significant results at the 0.06 ppm level.) Yet nothing in the Clean Air Act or the IQA prohibits EPA from independently analyzing the science—for example, by asking “different questions” from those asked by the study’s author, 2008 Final Rule, 73 Fed.Reg. at 16,455— and the only objections Mississippi offers to EPA’s independent analysis are either conclusory or require us to weigh in on what is apparently legitimate scientific debate. See id. (noting approval by members of CASAC of the statistical approach used in the reanalysis).
Mississippi’s challenge to EPA’s use of the epidemiological evidence fares no better. Though it claims EPA improperly relied on studies using ambient ozone data as a proxy for personal exposure, Mississippi neither challenges EPA’s explanation that very few epidemiological studies directly measuring personal exposure exist in the literature nor acknowledges EPA’s recognition that ambient measurements do not necessarily represent personal exposure levels and must
We repeat: it is not our job to referee battles among experts; ours is only to evaluate the rationality of EPA’s decision, and as we have explained, the agency did its part. And because we reject Mississippi’s challenge to the primary NAAQS, we must also reject its challenge to the secondary NAAQS. Mississippi’s petition for review is therefore denied.
III.
As discussed above, EPA’s review of the available scientific evidence led it to adopt a primary ozone NAAQS of 0.075 ppm. While Mississippi criticized EPA’s decision to reduce this standard from its prior level of 0.08 ppm, multiple state and local governments, environmental advocacy nonprofits, and public health non-profits contend that EPA did not go far enough. Thus, EPA finds itself in a situation reminiscent of Goldilocks and the Three Bears. On one side, Mississippi argued that EPA is too stringent with its ozone NAAQS; on the other side, the governmental and environmental petitioners argue that the NAAQS is too lax. But unlike Goldilocks, this court cannot demand that EPA get things “just right.” Rather, for EPA’s decision to survive these challenges, it need do no more than meet the statutory standards found in the Clean Air Act. “That the evidence in the record may also support other conclusions, even those that are inconsistent with [EPA’s], does not prevent us from concluding that [its] decisions were rational.... ” Lead Industries Ass’n,
The Act requires us to overturn any EPA action that is arbitrary, capricious, an abuse of discretion, or contrary to law. 42 U.S.C. § 7607(d)(9)(A). The governmental and environmental petitioners argue that EPA’s judgment — that a primary ozone NAAQS of 0.075 ppm is “requisite to protect the public health,” 42 U.S.C. § 7409(b)(1) — was arbitrary and capricious because EPA failed to rationally consider scientific evidence demonstrating adverse health effects at ozone levels below 0.075 ppm. They also argue that EPA acted contrary to law because it failed to calculate an adequate margin of safety, as required by section 109(b)(1) of the Act, 42 U.S.C. § 7409(b)(1). Finally, they argue that EPA violated its statutory duty to
A.
It is true that “[a]n agency’s failure adequately to consider a relevant and significant aspect of a problem may render its rulemaking arbitrary and capricious.” American Farm Bureau,
Provided EPA meets its obligation “to explain and expose every step of its reasoning,” American Lung Ass’n v. EPA,
The governmental and environmental petitioners argue that EPA failed to grapple with three major types of evidence that they claim favor a lower primary ozone NAAQS: controlled human exposure studies, epidemiological studies, and human exposure and health risk assessments. The record reveals, and petitioners do not dispute, that EPA considered the entire body of scientific evidence available to it, discussing each type of evidence at each stage of its analysis. See, e.g., 2007 Proposed Rule, 72 Fed.Reg. at 37,864-68; 2008 Final Rule, 73 Fed.Reg. at 16,452-70; see also id. at 16,439 (describing the range of evidence considered in the years-long review process). The petitioners argue instead that EPA’s conclusion that a level of 0.075 ppm is “requisite” to protect public health cannot be rationally drawn from this evidence. We disagree. EPA’s treatment of the evidence satisfies our deferential standard of review.
Petitioners argue that the controlled human exposure studies — in particular, the Adams studies — support a more protective primary NAAQS because they demonstrate adverse effects at the 0.060 ppm level. The Adams studies, published in 2002 and 2006, analyzed the results of laboratory experiments that directly measured the effects of ozone on humans’ respiratory health by exposing thirty subjects to ozone in a controlled environment. Adams tested his subjects at various ozone concentrations, including 0.08 ppm and 0.06 ppm, but at no levels in between. He found that a small number of subjects exposed to ozone at 0.06 ppm experienced lung function decrements of at least ten percent — a level EPA considers to be harmful (or “adverse”) to asthmatics. See 2008 Final Rule, 73 Fed.Reg. at 16,454-55. Petitioners argue that the 0.06 ppm Adams results were “unrebutted ‘substantial evidence’ ” favoring a lower standard, and that EPA’s decision to set the standard as high as 0.075 ppm “ ‘is not supported by substantial evidence.’ ” Environmental Pe
EPA relied on the Adams studies and other clinical studies to justify its decision to lower the primary ozone NAAQS from the 0.08 ppm level, concluding that they “provide[d] the most certain evidence of adverse health effects” at 0.080 ppm available. 2008 Final Rule, 73 Fed.Reg. at 16,478. EPA also conducted a reanalysis of the Adams (2006) study that found “small group mean decrements in lung function responses to be statistically significant at the 0.060 ppm exposure level.” Id. at 16,454. But EPA further concluded that the data at the 0.060 ppm level was too limited to support a reduction in the NAAQS to that level.
Each Adams study involved only thirty subjects, of which six at most experienced lung function decrements of ten percent or more at exposure levels below 0.080 ppm.
Thus, while the 0.08 ppm results were robust, EPA rationally treated the 0.06 ppm results as inconclusive. Perhaps more studies like the Adams studies will yet reveal that the 0.060 ppm level produces significant adverse decrements that simply cannot be attributed to normal variation in lung function. But at the time of EPA’s rulemaking, it was rational to treat the 0.06 ppm results with skepticism. The Adams results at 0.06 ppm indicate some degree of risk that some number of individuals might continue to experience health effects at and below 0.075 ppm, but
Petitioners counter that EPA has relied on even statistically nonsignificant results in the past when setting the primary ozone NAAQS, so the limitations of the Adams studies provide no basis for dismissing the evidence of adverse effects at that level. Environmental Petitioners’ Br. 20-21. Be that as it may, the question for this court is not what EPA has done in the past, or even what levels it rationally could have settled on, but only whether it has provided a rational explanation of how it treated the evidence before it. See ATA III,
The governmental and environmental petitioners next argue that EPA gave short shrift to the epidemiological studies. By using statistical techniques to analyze vast bodies of health and environmental data across large populations, epidemiological studies allow scientists to draw inferences about the harms of ozone without carefully calibrated laboratory experiments. EPA relied on over 250 such studies during its 2008 rulemaking. 2008 Final Rule, 73 Fed.Reg. at 16,455, 16,479. Petitioners point out that some studies found significant correlations between ozone concentration and adverse health outcomes at levels well below 0.075 ppm. See Comments of the American Lung Association, Environmental Defense, Sierra Club on the U.S. Environmental Protection Agency’s Proposed Revisions to the NAAQS for Ozone (Oct. 9, 2007), EPA-HQ-OAR-2005-0172-4261; Comments of American Thoracic Society, et al. (Oct. 9, 2007), EPA-HQOAR-2005-0172-4305. The studies were relatively consistent, and the results — as EPA admits — may help establish a causal relationship between the presence of ozone and the occurrence of adverse health effects. 2008 Final Rule, 73 Fed.Reg. at 16,450.
As with the Adams studies, EPA relied on the epidemiological studies to conclude that the existing standard of 0.08 ppm was too high. EPA noted that many epidemiological studies reported “statistically significant associations that generally extend down to ambient 03 concentrations that are below the level of the current standard” and considered these studies as part of the body of “new evidence demonstrating that exposures to 03 at levels below the level of the current standard are associated with a broad array of adverse health effects.” Id. at 16,471. EPA also explained, however, that “the epidemiological studies are not themselves direct evidence of a causal link between exposure to 03 and the occurrence of [health] effects,” id. at 16,479, and that evidence of this causal
Petitioners also challenge EPA’s interpretation of its own risk and exposure assessments. EPA did not rely heavily on them, though petitioners think it should have. These assessments model real-world interactions between a host of variables in order to predict health outcomes based on available data. 2008 Final Rule, 73 Fed.Reg. at 16,441. As such, they adhere to the inviolable law of data analysis, “garbage in; garbage out.” That is, as CASAC cautioned EPA, the risk and exposure assessments are only as reputable as the inputs upon which they rely to produce their predictions. Oct.2006 CASAC Letter, at 12; see also Letter from Dr. Rogene Henderson, CASAC Chair, to Stephen L. Johnson, EPA Administrator, at D-39 (Feb. 10, 2006), EPA-CASAC-06003 (discussing similar weaknesses in risk assessment for the secondary NAAQS). In this case, the inputs were the very data whose reliability EPA questioned at lower levels. Recognizing their limitations, we have previously approved EPA’s cautious treatment of risk and exposure assessments when EPA “consider[s] all aspects of the problem” and “catalogue^] its concerns.” See American Farm Bureau,
Having reasonably explained the limitations it believed existed in each of these bodies of scientific evidence, EPA concluded that the standard “must be set at a level appreciably below 0.080 ppm, the level at which there is considerable evidence of effects in healthy people.” 2008 Final Rule, 73 Fed.Reg. at 16,480; see also id. at 16,483 (“0.080 ppm [is] the level in controlled human exposure studies at which adverse effects have been demonstrated.”). EPA concluded that a standard set at 0.075 ppm “would be requisite to protect public health with an adequate margin of safety, including the health of sensitive subpopulations.” Id. at 16,483. EPA explained that a standard lower than 0.075 ppm was not required because it “would only result in significant further public health protection if, in fact, there is a continuum of health risks in areas with 8-hour average 03 concentrations that are well below the concentrations observed in the key controlled human exposure studies and if the reported associations observed in epidemiological studies are, in fact, causally related to 03 at those lower lev
B.
The governmental and environmental petitioners next argue that, even if the scientific evidence of adverse effects at ozone levels below 0.075 ppm remained uncertain, the overwhelming evidence of adverse effects at 0.080 ppm required a primary NAAQS lower than 0.075 ppm to ensure an adequate margin of safety. EPA is required to “allow[ ] an adequate margin of safety” in setting a primary NAAQS that is “requisite to protect the public health.” 42 U.S.C. § 7409(b)(1). By requiring an “adequate margin of safety,” Congress was directing EPA to build a buffer to protect against uncertain and unknown dangers to human health. Lead Industries Ass’n,
In light of this deferential standard, we have only rarely found that the agency failed to build in a margin of safety. See, e.g., American Farm Bureau,
C.
The governmental and environmental petitioners next argue that EPA failed to uphold its duty under the Act to provide “an explanation of the reasons” for departing from CASAC’s recommendations. 42 U.S.C. § 7607(d)(3); see also id. § 7607(d)(6)(A). Congress created CA-SAC in the 1977 Clean Air Act Amendments and tasked it with providing scientific advice to aid EPA in setting NAAQS. See id. § 7409(d)(2). Expressing its “desire for continued independent scientific review of the Environmental Protection Agency’s exercise of judgment,” H. Rep. No. 95-294, at 182 (1977), 1977 U.S.C.C.A.N. 1077, 1260-61, Congress directed CASAC to complete a review of the air quality criteria and primary and secondary NAAQS every five years and to “recommend to the Administrator any new national ambient air quality standards and revisions of existing criteria and standards as may be appropriate,” 42 U.S.C. § 7409(d)(2)(B).
When Congress created CASAC, the promulgation of NAAQS was in its infancy. In describing the role it envisioned for CASAC, Congress emphasized the valuable role that advisory committees and expert groups had played in reviewing the first criteria documents and air quality standards issued in the late 1960s and early 1970s, explaining that “[f]or nearly 10 years the scientific basis for setting ambient air quality standards has been reviewed, evaluated, subjected to outside criticism, and reevaluated.” H. Rep. No. 95-294, at 179-81, 1977 U.S.C.C.A.N. 1077, at 1258-60. CASAC was intended to replicate this role by “provid[ing] an independent source of review and advice to the Administrator and to the Congress.” Id. at 182. Thus, Congress explained that it established CASAC “[b]eeause of the admitted need for greater research, the importance of the national ambient air quality standards, the continuing controversy over the standards, and the committee’s desire for continued independent scientific review of the Environmental Protection Agency’s exercise of judgment.” Id.
Congress expected that CASAC’s central role would be one of scientific analysis, explaining that CASAC’s “main function” was “to assess the health and environmental effects of ambient air pollution.” Id. at 183. CASAC would “provide an outside mechanism for evaluating whether any pollutant may reasonably be anticipated to endanger public health or environment, for evaluating the scientific and medical data which might bear on this question, and for reviewing gaps in the available data and recommending additional needs for research.” Id. at 182. Given these functions, Congress expected that CASAC members would “be selected on the basis of their special expertise” in fields such as “environmental toxicology, epidemiology and/or clinical medicine.” Id. at 183.
Congress also required EPA to take CASAC’s expert scientific recommendations into account in promulgating NAAQS. Although EPA is not bound by CASAC’s recommendations, it must fully explain its reasons for any departure from them. Specifically, section 307(d)(3) of the Act mandates that when EPA proposes to issue new NAAQS or revise existing NAAQS, the proposed rule must include a “statement of its basis and purpose” that “set[s] forth or summarize[s] and provide[s] a reference to any pertinent find
Congress intended that CASAC’s expert scientific analysis aid not only EPA in promulgating NAAQS but also the courts in reviewing EPA’s decisions. As Congress explained, CASAC’s “views are to be included in the record of any such rulemaking proceeding and, therefore, to be considered by the courts in reviewing the Administrator’s action or inaction.” H. Rep. No. 95-294, at 182-83, 1977 U.S.C.C.A.N. 1077, 1260-62. In order to enable judicial review and to satisfy its statutory obligation to explain its reasons for departing from CASAC, EPA must be precise in describing the basis for its disagreement with CASAC. If EPA’s quarrel is with CASAC’s scientific analysis, then in order to preserve the integrity of CASAC’s scientific role, EPA must give a sound scientific reason for its disagreement. In reviewing such scientific explanations, we undertake a “searching and careful” inquiry into the facts “to ascertain whether there is substantial evidence in the record when considered as a whole which supports the Administrator’s determinations.” Lead Industries Ass’n,
In this case, the CASAC Ozone Review Panel was composed of twenty-three scientists who are professors, analysts, and other practitioners in fields such as medicine, anatomy, environmental science, and chemical engineering. Drawing on this substantial expertise, the twenty-three members of the panel, in an October 2006 letter to EPA following CASAC’s peer review of the second draft of the agency’s Ozone Staff Paper, unanimously recommended that “the current primary ozone NAAQS be revised and that the level that should be considered for the revised standard be from 0.060 to 0.070 ppm.” Oct. 2006 CASAC Letter, at 5. In explaining the basis for this recommendation, CASAC noted that “[a] large body of data clearly demonstrates adverse human health effects at the current level of the 8-hr primary ozone standard.” Id. According to CASAC, “[r]etaining this standard would continue to put large numbers of individuals at risk for respiratory effects and/or significant impact on quality of life including asthma exacerbations, emergency room visits, hospital admissions and mortality.” Id.
When EPA issued its notice of proposed rulemaking, it proposed to revise the primary ozone standard to within a range from 0.070 ppm, the high end of CASAC’s recommended range, to 0.075 ppm. 2007 Proposed Rule, 72 Fed.Reg. at 37,878. EPA explained why it believed a standard set below 0.070 ppm would be inappropriate. Id. at 37,880. In the final rule, EPA departed from CASAC’s recommended range and set the standard at 0.075 ppm. EPA acknowledged that this standard was “above the range recommended by the CASAC.” 2008 Final Rule, 73 Fed.Reg. at 16,482. In explaining its departure, EPA catalogued its disputes with CASAC over the interpretation of specific bodies of scientific evidence and also noted that “the basis for [CASAC’s] recommendation appears to be a mixture of scientific and policy considerations.” Id. “[T]here is,” EPA stated, “no bright line clearly directing the choice of level, and the choice of what is appropriate is clearly a public health policy judgment entrusted to the Administrator.” Id. at 16,482-83. In explaining this policy judgment, EPA reasoned that “[a] standard set at a level lower than 0.075 would only result in significant further public health protection if, in fact, there is a continuum of health risks in areas with 8-hour average 03 concentrations that are well below the concentrations observed in the key controlled human exposure studies and if the reported associations observed in epidemiological studies are, in fact, causally related to 03 at those lower levels.” Id. at 16,483. “Based on the available evidence,” EPA declared that it was “not prepared to make these assumptions.” Id. “Taking into account the uncertainties that remain in interpreting the evidence from available controlled human exposure and epidemiological studies at very low levels,” EPA concluded that “the likelihood of obtaining benefits to
This explanation rests largely on EPA’s policy judgment about the appropriate NAAQS level. We have explained that, where EPA operates within the realm of uncertain science, its decisions about the appropriate NAAQS level must “necessarily ... rest largely on policy judgments.” Lead Industries Ass’n,
But we are unable to determine whether CASAC reached any such scientific conclusion. Although CASAC stated that “overwhelming scientific evidence” supported its recommendation that the standard be set no higher than 0.070 ppm, Mar. 2007 CASAC Letter, at 2, it never explained whether this proposal was based on its scientific judgment that adverse health effects would occur at that level or instead based on its more qualitative judgment that the range it proposed would be appropriately protective of human health with an adequate margin of safety. Indeed, although CASAC concluded that “there is no longer significant scientific uncertainty regarding [its] conclusion that the current 8-hr primary NAAQS must be lowered,” given the “large body of data clearly demonstrating] adverse human health effects at the current level,” CA-SAC recognized that “[s]cientific uncertainty does exist with regard to the lower level of ozone exposure that would be fully-protective of human health.” Oct.2006 CASAC Letter, at 5.
To be sure, EPA’s statutory obligation to respond to CASAC does not evaporate whenever CASAC exercises judgment amidst scientific uncertainty. Quite to the contrary, had CASAC acknowledged uncertainty in the scientific evidence but explained that, based on its expert scientific judgment, it nonetheless believed adverse health effects were likely to occur at the
The task of determining what standard is “requisite” to protect the qualitative value of public health or what margin of safety is “adequate” to protect sensitive subpopulations necessarily requires the exercise of policy judgment. Here, EPA’s policy judgment was informed by its view of the limitations of the scientific evidence — namely, that at lower levels of ozone exposure, the clinical and epidemiological studies provide less conclusive evidence of the existence of adverse health effects. See 2008 Final Rule, 73 Fed.Reg. at 16,483 (noting “the uncertainties that remain in interpreting the evidence from available controlled human exposure and epidemiological studies at very low levels”). Striking a balance between “the increasing uncertainty associated with [its] understanding of the likelihood of such effects at lower 03 exposure levels” and “concern about the potential for health effects and their severity,” id. at 16,477, EPA set the standard at 0.075 ppm, a level the agency believed to be “appreciably below” the 0.08 ppm level at which both EPA and CASAC expressed certainty about the existence of adverse health effects, id. at 16,483. Absent a definitive scientific conclusion from CASAC that adverse health effects would occur at the 0.070 ppm level, we must assume that it too took these same considerations into account and simply exercised its judgment to recommend a standard set at a lower level. Although both CASAC and EPA must exercise public health policy judgment when confronted with scientific evidence that does not direct it to a specific outcome, it is to EPA’s judgment that we must defer.
In our view, this conclusion is perfectly consistent with the role Congress intended CASAC to play in the NAAQSsetting process. In order to ensure that EPA’s NAAQS decisions rest on sound scientific judgment, Congress required EPA not only to describe CASAC’s recommendations in any rulemaking but also, if it departs from such recommendations, to explain its reasons for doing so. See 42 U.S.C. § 7607(d)(3), (6). But in order for EPA to explain adequately its reasons for disagreeing with CASAC, CASAC itself must be precise about the basis for its recommendations. Because in this case CASAC failed to specify whether the 0.070 ppm level it recommended as a maximum rested on a scientific conclusion about the existence of adverse health effects at that level, EPA’s invocation of scientific uncertainty and more general public health policy considerations satisfies its obligations under the statute.
IY.
We turn finally to EPA’s decision to set the secondary ozone NAAQS “identical in every way to the revised primary standard.” 2008 Final Rule, 73 Fed.Reg. at 16,500. The governmental and environmental petitioners argue, among other things, that EPA’s failure to “specify a level of air quality ... [that] is requisite to protect the public welfare,” 42 U.S.C. § 7409(b)(2), violates the statute as interpreted in our decision in American Farm Bureau. Because we agree that EPA’s
As described above, the Clean Air Act requires secondary NAAQS to “specify a level of air quality the attainment and maintenance of which ... is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.” Id. Regarding ozone, EPA set the secondary NAAQS in 1997 to protect against harmful effects on vegetation and indirect effects on other ecosystem components. See 2008 Final Rule, 73 Fed.Reg. at 16,485. In the current review of the secondary standard, before EPA came to its final decision, agency staff examined new scientific evidence and risk assessments that evaluated ozone’s welfare effects. Id. On the basis of this new evidence, EPA staff concluded that the existing 0.08 ppm 8-hour standard was inadequate because ozone at that level directly causes adverse effects to vegetation and has indirect adverse effects on soil, water, and wildlife. 2007 Proposed Rule,
CASAC unanimously agreed with EPA staff that adverse effects on vegetation occur under the existing standard and that “it is not appropriate to try to protect vegetation ... by continuing to promulgate identical primary and secondary standards for 03.” 2008 Final Rule,
In the final rule, EPA agreed that new evidence indicates that ozone causes adverse effects on vegetation and related ecosystems at the current level of the secondary standard and concluded that it was appropriate to revise the secondary standard to provide increased protection. 2008 Final Rule, 73 Fed.Reg. at 16,496, 16,499-500. Regarding the recommendations to adopt a cumulative seasonal standard, EPA cited a staff analysis that found “significant overlap” between counties expected to meet the revised 8-hour primary standard and counties that would meet a cumulative seasonal standard. Id. at 16,-499. EPA “focused [its] consideration on a level for an alternative [seasonal] standard at the upper end of the proposed range (i.e., 21 ppm-hours)” and found “essentially no counties with air quality that would be expected both to exceed such an alternative [seasonal] standard and to meet the revised 8-hour primary standard.” Id. at 16,499-500. From this comparison, EPA concluded that merely revising the secondary standard to match the revised primary standard would “provide a significant degree of additional protection for vegetation” and that “a [seasonal] standard would be unlikely to provide additional protection
In American Farm Bureau, we rejected EPA’s explanation for setting the fine particulate matter secondary NAAQS — which protects public welfare from adverse visibility effects — identical to the primary fine particulate matter standard.
Relying on the statute’s plain language — EPA “shall specify a level of air quality the attainment and maintenance of which ... is requisite to protect the public welfare from any known or anticipated adverse effects,” 42 U.S.C. § 7409(b)(2)— we rejected EPA’s explanation, finding that EPA must “determine what level of visibility protection is requisite to protect the public welfare,” American Farm Bureau,
Although American Farm Bureau was decided after EPA issued the rule challenged here, the decision is binding on us now — a proposition that EPA nowhere disputes. Bradley v. School Board of City of Richmond,
EPA’s explanation for setting the secondary standard identical to the primary standard fails under American Farm Bureau. As we explained there, it is insufficient for EPA merely to compare the level of protection afforded by the primary standard to possible secondary standards and
EPA argues that it “identified a target level of protection in terms of a cumulative, seasonal standard.” Respondent’s Br. 122. In support, the agency points to the sentence in the final rule stating that EPA “focused [its] consideration on a level ... at the upper end of the proposed range (i.e., 21 ppm-hours).” 2008 Final Rule, 73 Fed.Reg. at 16,499-500. But neither this statement nor anything else EPA said indicated that the 21 ppm-hours level was “requisite to protect the public welfare.” Perhaps more importantly, EPA never explained why a 21 ppm-hours level would, in fact, be requisite to protect vegetation. That a seasonal standard of 21 ppm-hours was one of the levels proposed by EPA staff hardly shows that the level was “requisite to protect the public welfare.”
Also as in American Farm Bureau, EPA’s comparison between the primary and secondary standards “fails on its own terms.”
At oral argument, counsel for EPA repeatedly insisted that petitioners “tacitly conceded” that the agency identified a target level of protection by “eritieiz[ing] the reason EPA focused on 21 [ppm-hours].” Oral Arg. Rec. 1:50:43-51:06; see also id. 1:50:02-16. But counsel confuses assuming a premise for the sake of argument with conceding the point. Petitioners argue both that EPA failed to identify a target level of protection and that, even if EPA had in fact determined that the “requisite” level was 21 ppm-hours, that finding was irrational. See Environmental Petitioners’ Br. 35-37 (“EPA Acted Illegally and Arbitrarily in Failing to Identify the Level of Air Quality Requisite to Protect Against Adverse Vegetation Impacts.”); id. at 37-39 (“EPA’s Decision on the Secondary Standard Was Irrational.”); id. at 39-40 (“EPA’s Attempts to Justify Its Secondary Standard Were Groundless.”). Contending that settling on 21 ppm-hours would be senseless hardly precludes petitioners from arguing that EPA never expressly made the required determination.
Because EPA failed to determine what level of protection was “requisite to protect
Y.
For the foregoing reasons, we remand the secondary NAAQS to EPA for reconsideration in view of this opinion. In all other respects, the petitions for review are denied.
So ordered.
Notes
. Because Mississippi independently challenges EPA's failure to compare its 2008 and 1997 risk assessments, however, we also acknowledge the reasonableness of EPA's explanation for not doing so — namely, that a comparison would be "factually inappropriate,” would not account for the fact that "with similar risks, increased certainty in the risks” would engender greater concern, and would obscure the qualitativeness of EPA's approach. 2008 Final Rule, 73 Fed.Reg. at 16,-466. First, the 2008 risk assessment analyzed a number of health effects not included in the 1997 risk assessment, so the ultimate value of comparing the two assessments would be limited. Second, logic rejects comparisons of apples and oranges, which is how we would describe two data analyses subject to different geographic and demographic parameters. See, e.g., 2007 Proposed Rule, 72 Fed.Reg. at 37,851-52 (explaining that 2008 exposure analysis, an input to part of the risk assessment, relied on a model different from the one used in 1997). And finally, even if EPA should have compared the two risk assessments where they overlapped, EPA's failure to
. For that matter, EPA commits the same error, referring to "0.080” when it should refer to “0.08,” compare 2008 Final Rule, 73 Fed.Reg. at 16,444, with 1997 Final Rule, 62 Fed.Reg. at 38,859, but Mississippi does not note it, so we have no reason to think this reflects anything other than sloppy editing.
. To the extent Mississippi's complaint centers around EPA’s failure to peer review its reanalysis, we note that EPA’s IQA guidelines expressly disclaim a categorical peer-review policy, so even assuming Mississippi is right that the reanalysis was not peer reviewed, Mississippi's failure to explain why the alleged lack of peer review was improper is fatal. See American Petroleum Institute,
. EPA also cited the two studies a total of five times in the proposed rule, but we think this immaterial in light of Mississippi's failure to explain their importance to EPA’s final decision.
. The record includes conflicting accounts of the number of participants experiencing lung function decrements of ten percent or larger at 0.06 ppm. All accounts indicate that it was a small number, and never more than six. The precise number appears to depend on one's method of measuring lung function decrements. Compare Office of Air Quality Planning and Standards, EPA, Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information (“Staff Paper”), § 3.3.1.1.1 (2007), EPA-452/R-07-007, with Letter from Dr. Rogene Henderson, CASAC Chair, to Stephen L. Johnson, EPA Administrator ("Mar.2007 CASAC Letter”), at C-31-32 (Mar. 26, 2007), EPA-CASAC07-002.
. This conclusion concerns only disagreements regarding the certainty of the science; of course, EPA could also have accepted CA-SAC’s scientific conclusion and explained its view that any health effects at that level were not severe enough to be considered "adverse.
