Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-09-01011/USCOURTS-caDC-09-01011-0/pdf.json

Parties Involved:
Coalition of Battery Recyclers Association
Petitioner
Environmental Protection Agency
Respondent

Document Text:

Notice: This opinion is subject to formal revision before publication in the

Federal Reporter or U.S.App.D.C. Reports. Users are requested to notify the

Clerk of any formal errors in order that corrections may be made before the

bound volumes go to press.

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 6, 2010 Decided May 14, 2010

No. 09-1011

COALITION OF BATTERY RECYCLERS ASSOCIATION,

PETITIONER

v.

ENVIRONMENTAL PROTECTION AGENCY,

RESPONDENT

Consolidated with No. 09-1012

On Petitions for Review of Final Rule 

of the United States Environmental Protection Agency

Michael B. Wigmore argued the cause for petitioner

Coalition of Battery Recyclers Association in No. 09-1011. 

Dennis Lane argued the cause for petitioner The Doe Run

Resources Corporation in No. 09-1012. With them on the briefs

were Robert N. Steinwurtzel and Sandra P. Franco.

USCA Case #09-1011 Document #1244831 Filed: 05/14/2010 Page 1 of 20
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Eric G. Hostetler, Attorney, U.S. Department of Justice,

argued the cause and filed the brief for respondent.

Before: SENTELLE, Chief Judge, ROGERS and GARLAND,

Circuit Judges.

Opinion for the Court by Circuit Judge ROGERS.

ROGERS, Circuit Judge: Upon review of the air quality

criteria and national ambient air quality standards (“NAAQS”),

the Environmental Protection Agency revised the primary and

secondary NAAQS for lead. See National Ambient Air Quality

Standards for Lead, 73 Fed. Reg. 66,964 (Nov. 12, 2008)

(“Final Rule”). The revision was designed to provide, in light

of recent science, the requisite protection of public health and

welfare by revising the permissible level of lead in ambient air

and revising the averaging time over which the level must be

met. The final rule also revised data handling procedures and

emissions inventory reporting requirements and provided

guidance on implementation. The Coalition of Battery

Recyclers Association and the Doe Run Resources Corporation

(together “petitioners”) contend EPA action was arbitrary and

capricious in multiple ways. Upon review of the rulemaking

record, we are unpersuaded and we deny the petitions for

review.

I.

Pursuant to sections 108 and 109 of the Clean Air Act, 42

U.S.C. §§ 7408–09, EPA regulates air pollutants, “emissions of

which, in [the Administrator’s] judgment, cause or contribute to

air pollution which may reasonably be anticipated to endanger

public health or welfare,” id. § 7408(a)(1)(A). Lead (“Pb”)

emitted into the air can be inhaled or ingested and then absorbed

into the bloodstream, potentially leading to a broad range of

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adverse health effects including adverse neurological effects in

children. See Final Rule, 73 Fed. Reg. at 66,972–73, 66,975–76. 

In 1978 EPA established primary and secondary NAAQS for

lead of 1.5 micrograms of lead per cubic meter of air (μg/m3)

averaged over a calendar quarter. See National Primary and

Secondary Ambient Air Quality Standards for Lead, 43 Fed.

Reg. 46,246 (Oct. 5, 1978) (“1978 Lead NAAQS”). At this

time, adverse neurocognitive effects in children had not been

shown for blood lead levels below 50 micrograms of lead per

deciliter of blood (μg/dL), and the 1978 NAAQS aimed to

prevent most children from exceeding a blood lead level of

30 μg/dL. See id. at 46,246, 46,252. However, later studies

showed adverse neurocognitive effects in children with blood

lead levels below 10 μg/dL. See Final Rule, 73 Fed. Reg. at

66,975–76, 66,984.

EPA began reviewing the NAAQS for lead in 2004,

considering some 6,000 studies and concluding “there is now no

recognized safe level of Pb in children’s blood.” Id. at 66,984. 

As part of its review, EPA produced a “Criteria Document”

assessing the latest scientific information regarding health

effects associated with lead in the ambient air. See id. at

66,966–67. EPA’s review “shift[ed] focus from identifying an

appropriate target population mean blood lead level and instead

focuse[d] on the magnitude of effects of air-related Pb on

neurocognitive functions.” Id. at 66,984. EPA developed an

“evidence-based framework” that examined published studies

addressing the relationship between IQ loss in children and air

lead levels. Id. EPA relied to a lesser extent on risk estimates

derived from risk assessment models. Id. at 67,006. Through its

review, EPA sought to identify an air lead level “that would

prevent air-related IQ loss (and related effects) of a magnitude

judged by the Administrator to be of concern in populations of

children exposed to the level of the standard.” Id. at 66,997.

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To relate IQ loss to air lead levels, EPA used its evidencebased framework to determine relationships between air lead

levels and blood lead levels (the “air-to-blood ratio”) and

between blood lead levels and IQ loss (the “concentrationresponse” relationship). EPA concluded that for each μg/m3

increase of lead in air, children’s blood lead levels increase by

5–10 μg/dL, i.e., the air-to-blood ratio ranged from 1:5 to 1:10. 

Id. at 67,002. EPA selected an air-to-blood ratio of 1:7 “as a

generally central value within this range.” Id. at 67,004. EPA

also concluded that the concentration-response relationship is

nonlinear, with greater incremental IQ loss occurring at lower

blood lead levels, and thus that analyses of children with blood

lead levels closest to those of children in the United States today

were most relevant. Id. at 67,002. EPA determined that the

most recently measured mean blood lead level of U.S. children

five years old and younger was 1.8 μg/dL, id., and selected four

study groups involving children with mean blood lead levels

between 2.9 and 3.8 μg/dL rather than groups with higher mean

blood lead levels, id. at 67,003. To “avoid[] focus on a single

estimate that may be unduly influenced by one single analysis,”

each of the four selected groups was from a different study. Id.

Using each group’s reported mean IQ point decrease per μg/dL

increase in blood lead levels, i.e., using the slope of the

concentration-response relationship for each group, EPA

calculated the median concentration-response slope to be

-1.75 μg/dL. Id.

After considering public comments and the

recommendations of its independent scientific review

committee, the Clear Air Scientific Advisory Committee

(“CASAC”), see 42 U.S.C. § 7409(d)(2), as well as “the

uncertainties in the health effects evidence and related

information” and the role of IQ loss in its evidence-based

framework, EPA concluded that an allowable airborne

lead–related loss of two IQ points should be used to set the

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NAAQS standard. Final Rule, 73 Fed. Reg. at 67,005. CASAC

had stated that “a population loss of 1–2 IQ points is highly

significant from a public health perspective” and that such loss

should be prevented, recommending an air lead level standard

of 0.20 μg/m3 or less. Id. at 66,999–67,000. Combining the

blood-to-air ratio of 1:7, the concentration-response slope of

-1.75 μg/dL, and the allowable air-related IQ loss of 2 points,

EPA concluded that an air lead level standard of 0.15 μg/m3

“would be sufficient to protect public health with an adequate

margin of safety” and “is neither more nor less stringent than

necessary for this purpose.” Id. at 67,007.

EPA also concluded that the appropriate averaging time for

the air lead level standard is a rolling three-month period with a

maximum (not-to-be-exceeded) form evaluated over a period of

three years. Id. at 66,996. EPA had initially proposed an

averaging time of either a calendar quarter or a calendar month,

National Ambient Air Quality Standards for Lead, 73 Fed. Reg.

29,184 (May 20, 2008) (“NPRM”), with CASAC recommending

a monthly averaging period, see Final Rule, 73 Fed. Reg. at

66,993. EPA based its conclusion on scientific evidence

indicating that blood lead levels increase quickly in response to

increased lead exposure, that blood lead levels measured at the

same time as an IQ test (“concurrent blood lead levels”) are

most strongly associated with IQ response, and that these

concurrent blood lead levels reflect lead exposure over the past

one to three months. Id. at 66,992–93. On November 12, 2008,

EPA published the final rule, revising the primary and secondary

NAAQS for lead to 0.15 μg/m3

 averaged over a rolling threemonth period. Id. at 66,964.

II.

Petitioners assert that the revised primary lead NAAQS is

overprotective, contending that (A) EPA did not provide

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sufficient record support for basing the standard on preventing

a decrease of more than two IQ points, (B) reliance on particular

studies relating blood lead levels and IQ was arbitrary and

capricious, and (C) selection of a lead standard of 0.15 μg/m3

was arbitrary and capricious when measured as an average over

a rolling three-month period. Consistent with our standard of

review, see Lead Indus. Ass’n v. EPA, 647 F.2d 1130, 1145–48

(D.C. Cir. 1980); 42 U.S.C. § 7607(d)(9), we conclude these

contentions lack merit because there is substantial record

evidence to support EPA’s conclusions that the population of

children exposed to air lead levels above the revised NAAQS

could suffer, and should be prevented from suffering, average

losses of more than two IQ points, that greater incremental IQ

loss occurs at lower relative blood levels and the more relevant

IQ analyses are those of children with blood levels closest to

today’s population of children, and that a standard of 0.15 μg/m3

measured as a three-month rolling average is required to protect

public health with an adequate margin of safety.

A.

Sensitive populations; focus on IQ decrements. Petitioners’

assertion that the revised lead NAAQS is overprotective because

it is more stringent than necessary to protect the entire

population of young U.S. children ignores that the Clean Air Act

allows protection of sensitive subpopulations. Primary NAAQS

are those “which in the judgment of the Administrator, . . .

allowing an adequate margin of safety, are requisite to protect

the public health.” 42 U.S.C. § 7409(b)(1). In Whitman v.

American Trucking Ass’ns, 531 U.S. 457, 475–76 (2001), the

Supreme Court interpreted “requisite to protect” as “not lower

or higher than is necessary . . . to protect the public health with

an adequate margin of safety.” This court, en banc, cited the

Senate Report accompanying the Clean Air Act explaining that

EPA should set standards providing “a reasonable degree of

protection . . . against hazards which research has not yet

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identified.” Natural Res. Def. Council v. EPA, 824 F.2d 1146,

1152 (D.C. Cir. 1987) (en banc) (quoting S. REP. NO. 91-1196,

at 10 (1970)) (emphasis and omission in Natural Res. Def.

Council). And so this court has held that “NAAQS must protect

not only average healthy individuals, but also ‘sensitive

citizens’” such as children, and “[i]f a pollutant adversely affects

the health of these sensitive individuals, EPA must strengthen

the entire national standard.” Am. Lung Ass’n v. EPA, 134 F.3d

388, 389 (D.C. Cir. 1998) (quoting S. REP. NO. 91-1196 at 10);

see also Lead Indus. Ass’n, 647 F.2d at 1152–53. 

In the Final Rule EPA explained that the scientific evidence

showing the impact of lead exposure in young children in the

United States led it “to give greater prominence to children as

the sensitive subpopulation in this review,” Final Rule, 73 Fed.

Reg. at 66,975, and to focus its revision of the lead NAAQS on

“the sensitive subpopulation that is the group of children living

near [lead emission] sources and more likely to be exposed at

the level of the standard,” id. at 67,000. Given the recent

scientific evidence on which it relied, EPA’s decision to base the

revised lead NAAQS on protecting the subset of children likely

to be exposed to airborne lead at the level of the standard was

not arbitrary or capricious.

Petitioners’ suggestion that EPA failed to explain

adequately its shift in focus, from blood lead levels in the

original 1978 lead NAAQS to IQ decrements in children in the

revised NAAQS, is without merit. In the rulemaking EPA

explained that although the 1978 NAAQS was based on

determining a maximum safe blood lead level for children,

current scientific evidence no longer recognized a safe blood

lead level, and EPA consequently adopted a different focus

when revising the lead NAAQS. See NPRM, 73 Fed. Reg. at

29,229; Final Rule, 73 Fed. Reg. at 66,984. EPA further

explained that epidemiological studies of cognitive effects and

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lead exposure commonly use IQ scores and that the scientific

literature supports the conclusion that lead exposure causes IQ

loss in children. See Final Rule, 73 Fed. Reg. at 66,976. As

EPA noted in its brief, EPA does not view blood lead levels as

adverse health effects under the Clean Air Act, and both the

1978 and 2008 lead NAAQS focused on preventing adverse

health effects such as neurocognitive effects. See id. at

66,983–84; 1978 Lead NAAQS, 43 Fed. Reg. at 46,252–53. 

Petitioners further contend EPA’s use of IQ decrements to

revise the lead NAAQS was arbitrary and capricious because IQ

measurements are more uncertain than blood lead level

measurements. They assert that confounding factors such as

environmental factors affect IQ scores and that the population

significance of IQ loss is imprecise. However, EPA explained

that a large number of high quality studies support the inference

that lead exposure causes population IQ loss, and that animal

studies in which confounding factors are not present show that

low levels of lead cause neurobehavioral effects. See Final

Rule, 73 Fed. Reg. at 66,984 n.56. Petitioners claim that EPA

has acknowledged the standard error of measurement for IQ is

between three and four IQ points, and so assert that an IQ

decrement of two points therefore “cannot be detected at the

level of an individual.” Pet’rs Br. 32. This assertion confuses

the “‘critical’ distinction between population and individual

risk,” wherein a small change in IQ at the level of an individual

is a substantial change at the level of a population, as noted by

EPA when citing the discussion of the differences between

individual-level and population-level data in the Criteria

Document. See Final Rule, 73 Fed. Reg. at 66,976. Thus any

suggestion by petitioners that EPA did not adequately respond

to comments on the IQ test error rates, assuming this issue was

not forfeited by their failure to resubmit the comments as

directed in the notice of proposed rulemaking, see NPRM, 73

Fed. Reg. at 29,190, is without merit.

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Petitioners also protest, while conceding that CASAC

concluded a population loss of two IQ points “is [a] highly

significant” public health problem, Final Rule, 73 Fed. Reg. at

67,000, that EPA did not provide adequate record support for its

decision to protect against a population loss of more than two IQ

points. In the Final Rule and the Criteria Document EPA

explained that a mean population loss of two IQ points would

cause both a substantial decrease in the percentage of the

population achieving very high IQ scores and a substantial

increase in the percentage achieving very low scores. See id. at

66,976. In addition to citing CASAC’s conclusion, EPA cited

the comments of the American Academy of Pediatrics and state

health agencies that such a loss should be prevented. See id. at

67,000. These explanations sufficiently support EPA’s decision

to prevent a population loss of more than two IQ points. 

Regardless of whether EPA sufficiently explained its decision

not to follow the recommendation of CASAC and others to

further reduce IQ loss, a deficiency there would not lend support

to petitioners’ contention that the revised lead NAAQS is

overprotective. 

Additionally, while petitioners suggest EPA ignored record

evidence that population IQ has not increased commensurate

with decreasing blood lead levels over the past several decades,

EPA’s response to comments on the proposed rule stated there

is evidence that IQ scores have increased by an average of three

points per decade in the United States over the last several

decades and that IQ tests are routinely renormalized to adjust for

these increases. See EPA Responses to Significant Comments

on the 2008 Proposed Rule on National Ambient Air Quality

Standards for Lead, at 30–31 (Oct. 2008) (“Response to

Comments”). EPA’s response also explained these increases

may be due to improvements in nutrition and to other societal

and environmental factors as well as to reduced exposure to

lead, and concluded from an analysis of the scientific evidence

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that the decline in blood lead levels over the past several

decades contributed to the increase in IQ over that time period.

For these reasons we conclude that EPA adequately justified

its decision to prevent a loss of more than two IQ points in the

population of children exposed to the level of the revised

NAAQS. Petitioners’ reliance on In re Permian Basin Area

Rate Cases, 390 U.S. 747 (1968), to support their contention that

the revised lead NAAQS is overprotective, is misplaced. The

record shows EPA met its “oblig[ation] at each step of its

regulatory process to assess the requirements of the broad public

interests entrusted to its protection by Congress,” id. at 791, by

considering what lead NAAQS “is requisite to protect public

health, including the health of sensitive groups, with an adequate

margin of safety,” Final Rule, 73 Fed. Reg. at 67,006.

B.

Selection of scientific studies. Petitioners contend that the

record does not support EPA’s decision to exclude from its

determination of the concentration-response slope three

additional study groups involving children with blood lead

levels greater than those of current U.S. children but below

10 μg/dL. The four study groups EPA used to determine the

concentration-response slope were (1) a group from the

“Lanphear” study analyzing blood lead levels below 7.5 μg/dL,

(2) a group from the “Téllez-Rojo” study analyzing blood lead

levels below 5 μg/dL, (3) the “Canfield” study analyzing blood

lead levels below 10 μg/dL, and (4) the “Bellinger and

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Needleman” study analyzing blood lead levels below 10 μg/dL.1

See Final Rule, 73 Fed. Reg. at 67,003 (Table 3). Like the

Canfield and the Bellinger and Needleman studies on which

EPA relied, the three study groups petitioners wanted EPA to

use, namely an additional group from the Lanphear study and

two additional groups from the Téllez-Rojo study, involved

blood lead levels below 10 μg/dL. Petitioners contend that by

excluding the three study groups EPA did not rely on the latest

scientific knowledge, that the studies’ concentration-response

slopes do not continuously become steeper as blood lead levels

decrease, that there is a larger difference in the steepness of such

slopes above and below 10 μg/dL than above and below

5 μg/dL, and thus that EPA should have included the three

additional study groups because they involved blood lead levels

below 10 μg/dL.

However, EPA explained that the scientific evidence, as

well as CASAC’s recommendations, supported its conclusion

that the concentration-response relationship is nonlinear, in the

sense that a given increase in blood lead levels would cause a

greater IQ loss in a population with low blood lead levels than

a population with higher blood lead levels. See id. at 67,002. 

EPA reasonably concluded from this evidence that studies

involving children with blood lead levels closer to the mean

1

 See B.P. Lanphear et al., Low Level Environmental Lead

Exposure and Children’s Intellectual Function: An International

Pooled Analysis,” 113 Envtl. Health Perspectives 894 (2005); M.M.

Téllez-Rojo et al., Longitudinal Associations between Blood Lead

Concentrations < 10 μg/dL and Neurobehavioral Development in

Environmentally-Exposed Children in Mexico City, 118 Pediatrics

e323 (2006); R.L. Canfield et al., Intellectual Impairment in Children

with Blood Lead Concentrations below 10 μg per Deciliter, 348 New

Engl. J. Med. 1517 (2003); D.C. Bellinger & H.L. Needleman et al.,

Intellectual Impairment and Blood Lead Levels [letter], 349 New Eng.

J. Med. 500 (2003).

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blood lead level of today’s population of U.S. children would

provide a more representative estimate of the concentrationresponse slope. Id. EPA’s decision not to rely on the three

studies identified by petitioners is practically self-evident from

the table included in the rulemaking, see id. at 66,978–79 (Table

1), and EPA’s explanation for not relying on these three studies

was reasonable. EPA explained that it had included from the

Lanphear and Téllez-Rojo studies only the study group with “a

mean blood Pb level closest to today’s mean for U.S. children.” 

Id. at 67,003. EPA further explained that it had “identified four

different studies” to use in determining the concentrationresponse slope and thus “avoid[ed] focus on a single estimate

that may be unduly influenced by one single analysis.” Id.

No less, contrary to petitioners’ view, did EPA reasonably

explain why it relied more on the evidence-based framework

than on the risk assessment model results, results that petitioners

assert contradict EPA’s conclusion that a given increase in blood

lead levels would cause a greater IQ loss at lower blood lead

levels than at higher blood lead levels. EPA explained it

considered its risk assessment model results but gave them less

weight than the results in the published studies considered in its

evidence-based framework, because the risk assessment models

were associated with “important uncertainties and limitations”

related to modeling air lead dispersion, lead exposure pathways,

and other factors. Id. at 66,981, 67,006. In addition, EPA noted

that the results obtained from the risk assessment models were

“roughly consistent with and generally supportive of” the airrelated IQ loss estimates EPA determined using its evidencebased framework. Id. at 67,006 & n.84. To the extent

petitioners rely on the location-specific urban case studies from

the risk assessment models, EPA noted that the population

exposures modeled in the general urban and primary lead

smelter sub-area case studies “relate more closely to the airrelated IQ loss evidence-based framework” than the locationUSCA Case #09-1011 Document #1244831 Filed: 05/14/2010 Page 12 of 20
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specific urban case studies. Id. at 67,006 n.84. To the extent

petitioners rely on the lower ends of the ranges of IQ losses

estimated by the general urban case study, EPA observed both

that these lower ends “do[] not fully represent the risk associated

with all air-related pathways,” id. at 66,981, and that at a level

of 0.2 μg/m3

 the range of IQ loss estimates provided by the

general urban and primary lead smelter sub-area case studies

“are inclusive of the range of estimates” derived from the

evidence-based framework for that level, id. at 67,006 n.84. 

Petitioners fare no better in contending EPA unreasonably

assumed the relationship between blood lead levels and IQ was

linear by determining a single number (-1.75 μg/dL) for the

concentration-response slope. EPA concluded from “the weight

of the current evidence” that the concentration-response

relationship is “nonlinear, with steeper slopes at lower blood Pb

levels,” but “recognize[d] uncertainty in the quantitative

characterization of the nonlinearity in the blood Pb–IQ loss

relationship.” Id. at 67,003. Petitioners’ reliance on Natural

Resources Defense Council, 824 F.2d at 1165, where the court

stated that “there is no particular reason” to think straight-line

extrapolation from known to unknown harm levels provides an

accurate prediction of harm, undercuts rather than supports their

contention. Even if EPA were using the value of -1.75 μg/dL to

extrapolate an IQ at a lower blood level rather than to estimate

an IQ loss at a particular air lead level, the court there concluded

from the limitations of extrapolation not that EPA could not

extrapolate, but that “by its nature the finding of risk is uncertain

and the Administrator must use his [or her] discretion to meet

the statutory mandate” of the particular Clean Air Act provisions

involved. Id. 

EPA thus adequately justified its decision to rely on

analyses of IQ in children with blood lead levels closest to those

of today’s population of children when revising the lead

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NAAQS. To the extent petitioners contend the connection

between IQ loss and lead exposure is quantitatively uncertain,

EPA has fulfilled its obligations to “engage in reasoned

decision-making,” Am. Lung Ass’n, 134 F.3d at 392, and to “err

on the side of caution by setting primary NAAQS that ‘allow[]

an adequate margin of safety,’” Am. Trucking Ass’ns v. EPA,

283 F.3d 355, 369 (D.C. Cir. 2002) (quoting 42 U.S.C.

§ 7409(b)(1)) (alteration in Am. Trucking).

C.

Non-conversion with three-month rolling average.

Petitioners contend EPA was arbitrary and capricious not in

selecting a rolling three-month averaging period, but in failing

to convert the 0.15 μg/m3 air lead level from an annual basis to

a three-month basis. This contention lacks merit. EPA based its

selection of a rolling three-month average on different studies

than its selection of the 0.15 μg/m3

 standard. Compare Final

Rule, 73 Fed. Reg. at 66,991–96 with id. at 66,996–67,007. 

From the studies considered in determining the averaging

period, EPA concluded that the scientific evidence “does not

specify the duration of a sustained air concentration associated

with a particular blood Pb contribution” but does “support[] the

importance of time periods on the order of three months or less.” 

Id. at 66,994. Petitioners’ characterization of the 0.15 μg/m3

standard as the product of a unit conversion error is thus inapt.

EPA did rely on at least two published studies referring to

annual or yearly averages: a World Health Organization study

providing an air lead guideline of 0.5 μg/m3

 averaged over an

annual period, and a study by S.R. Hilts reporting results of

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annual blood lead level tests of children living near a smelter.2

EPA relied on both studies in deriving an air-to-blood ratio

rather than in determining the relationship between changes in

blood lead levels and IQ. See Final Rule, 73 Fed. Reg. at

66,973–74. Petitioners fail to demonstrate either study

determined the length of exposure to a particular average

ambient air lead level that resulted in a particular blood lead

level response, see id. at 66,994, and so fail to show that EPA’s

conclusions regarding the lead NAAQS level are valid only for

exposures to lead averaged over a period of one year. 

Furthermore, petitioners do not dispute that EPA explained that

the studies on which it based its selection of the averaging

period indicated that adverse health effects may result from lead

exposure over a period of one to three months. See id. at

66,993.

Petitioners erroneously conclude that because EPA’s risk

assessment models could accept inputs only of annual average

ambient air lead concentrations, see id. at 66,980 & n.45, EPA

calculated the 0.15 μg/m3

 level based on annual average air lead

exposure rather than three-month exposure. As detailed in

EPA’s Criteria Document, the annual average values were used

in the risk assessment models to estimate blood lead levels

rather than IQ responses to blood lead levels. However, as EPA

explained, the use of annual average ambient air lead

concentrations in the risk assessment modeling was an artifact

of the models themselves, and EPA adjusted the input annual

concentrations to correspond to monthly or quarterly averaging

times. See id.; see also id. at 66,995; Response to Comments at

9. 

2

 See World Health Organization, Air Quality Guidelines for

Europe 33 (2d ed. 2000); S.R. Hilts, Effect of Smelter Emission

Reductions on Children’s Blood Lead Levels, 303 Sci. Total Env’t 51,

52 (2003).

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The rulemaking thus demonstrates that EPA adequately

explained that it did not determine the 0.15 μg/m3

 air lead level

by assuming exposure to that level over a period of one year,

and that EPA reasonably concluded and adequately explained

that a lead NAAQS of 0.15 μg/m3

 measured as a three-month

rolling average is requisite to protect public health with an

adequate margin of safety.

III.

The Lanphear study investigated the concentration-response

relationship between blood lead levels and IQ changes, and

provided what EPA described as “the most compelling

evidence” for effects of lead on IQ at blood lead levels below

10 μg/dL and for the nonlinearity of these effects. Final Rule,

73 Fed. Reg. at 66,977. Petitioners contend the Lanphear study

contained such errors that EPA acted arbitrarily and capriciously

in relying on results from the study without first obtaining and

making public the underlying data for the study. However, in

American Trucking, 283 F.3d 355, this court rejected the notion

that EPA had improperly failed to obtain and make public data

underlying studies on which it had relied during a NAAQS

rulemaking, holding that “[t]he Clean Air Act imposes no such

obligation” and that “requiring agencies to obtain and publicize

the data underlying all studies on which they rely would be

impractical and unnecessary.” Id. at 372 (quotation marks

omitted). 

Petitioners attempt to distinguish their request on the

ground that in American Trucking the court was addressing

requests for data underlying several studies, while they request

only that EPA obtain and make public the data underlying the

Lanphear study. This distinction finds no support in the

reasoning of American Trucking. Rather than distinguishing

between an agency’s burden in obtaining data from one versus

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many studies, the court distinguished EPA’s reliance on a

study’s results from its reliance on the raw data underlying such

results, noting that raw data often is unavailable due to

proprietary interests of a study’s scientific investigators or

confidentiality agreements with study participants. See id.

Petitioners do not contend EPA possessed the underlying data

but failed to include it in the rulemaking record. Cf. Am. Radio

Relay League, Inc. v. FCC, 524 F.3d 227, 237–38 (D.C. Cir.

2008).

Petitioners’ reliance on EPA’s regulation concerning

requests for data under the Freedom of Information Act, 5

U.S.C. § 552 (“FOIA”), is forfeited. This regulation provides

that in response to a FOIA request, EPA shall request and make

public “research data relating to published research findings

produced under an award” of an EPA grant, subject to privacy

and other considerations. 40 C.F.R. § 30.36(d). Petitioners

cited this regulation for the first time during rebuttal oral

argument, affording EPA no opportunity to respond. See Ark

Las Vegas Rest. Corp. v. NLRB, 334 F.3d 99, 108 n.4 (D.C. Cir.

2003). Nor did petitioners preserve this argument by

mentioning their separate FOIA request for the Lanphear study

data in a footnote of their brief, without citing 40 C.F.R. §

30.36(d). See, e.g., Nat’l Mining Ass’n v. Mine Safety & Health

Admin., 599 F.3d 662, 671 (D.C. Cir. 2010); NSTAR Elec. &

Gas Corp. v. FERC, 481 F.3d 794, 800 (D.C. Cir. 2007). In any

event, the issue raised by petitioners in the instant case involves

whether EPA has a general duty to obtain and make public

underlying data as part of a rulemaking, rather than any specific

duties related to FOIA releases; more generally the regulation

concerns EPA’s reservation of rights in intangible property

related to its grant awards, and the court has no occasion to note

more than that the regulation does not apply here.

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Similarly unavailing is petitioners’ contention that EPA did

not respond adequately to comments concerning errors in the

Lanphear study. EPA responded to petitioners’ comments by

noting that errors in Table 4 and two typographical errors in the

Lanphear study had been corrected and explaining that these

corrected errors did not affect the portions of the study on which

EPA had relied. See Response to Comments at 72. EPA also

explained in response to petitioners’ questioning of Figure 3 of

the Lanphear study how petitioners had misinterpreted the

statistical methods involved in the figure and that EPA’s

conclusions from the Lanphear study did not depend on the

figure. See id. at 24–25. EPA further observed that its

confidence in the Lanphear study had been reaffirmed by the

“Rothenberg” study, which had re-analyzed the Lanphear data

and confirmed the nonlinear relationship between IQ and blood

lead levels shown in Figure 3 of the Lanphear study.3

 See id. at

25.

Consequently, petitioners have failed to identify errors in

the Lanphear study that would make EPA’s reliance on it

arbitrary and capricious, and EPA thus appropriately considered

the Lanphear study and was not required to obtain and make

public the data underlying the Lanphear study.

IV.

Finally Doe Run Resources, Inc., separately contends that

EPA erroneously concluded it lacked statutory authority under

the Clean Air Act to consider the bioavailability of lead sulfides

when determining compliance with the lead NAAQS. Doe Run

asserts that lead sulfides are less bioavailable than other forms

3

 See S.J. Rothenberg & J.C. Rothenberg, Testing the

Dose-Response Specification in Epidemiology: Public Health and

Policy Consequences for Lead, 113 Envtl. Health Persp. 1190 (2005).

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of lead and thus less likely to contribute to health risks, and that

EPA’s NAAQS compliance evaluations consequently should

treat low-bioavailable lead sulfides as “policy relevant

background” with “in effect, a waiver from the general NAAQS

rule.” Pet’rs Br. 55–56. EPA declined to determine compliance

with the lead NAAQS based on the bioavailability of lead

sulfides, explaining that it “must determine compliance with the

standard” pursuant to Clean Air Act § 109(b), 42 U.S.C.

§ 7409(b). See Response to Comments at 65.

The term “policy-relevant background” does not appear in

the Clean Air Act, and in the context of the lead NAAQS, EPA

defines “policy-relevant background” as natural emissions of

lead into the air from non-anthropogenic sources as well as lead

from non-air sources. See NPRM, 73 Fed. Reg. at 29,192. In

responding to comments EPA stated that evidence indicates the

bioavailability of lead sulfides increases over time and that EPA

considered this variable bioavailability in revising the lead

NAAQS. See Response to Comments at 10. In its brief on

appeal, EPA noted that concentrations of ambient lead near lead

mines or smelters are not naturally occurring background

concentrations. Resp’t Br. 57 n.27. Under the circumstances,

EPA reasonably concluded Doe Run’s request to treat the

bioavailability of lead sulfides differently was effectively a

request for a waiver from the lead NAAQS.

Applying the familiar two-step analysis under Chevron,

U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467

U.S. 837 (1984), seeNatural Res. Def. Council v. EPA, 489 F.3d

1364, 1371 (D.C. Cir. 2007), we conclude Doe Run’s contention

fails at both steps. First, Congress provided in the Clean Air Act

that primary NAAQS “shall be ambient air quality standards the

attainment and maintenance of which in the judgment of the

Administrator . . . are requisite to protect the public health.” 42

U.S.C. § 7409(b)(1). EPA is required to designate “any area that

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does not meet (or that contributes to ambient air quality in a

nearby area that does not meet) the national primary or

secondary ambient air quality standard for the pollutant” as

“nonattainment.” Id. § 7407(d)(1). Further, EPA “may not

promulgate a redesignation of a nonattainment area (or portion

thereof) to attainment unless” it “determines that the area has

attained the national ambient air quality standard.” Id.

§ 7407(d)(3)(E)(i). Additionally, Congress addressed the

circumstances under which attainment could be waived, e.g., as

with certain particulate matter sources, see 42 U.S.C. § 7513(f),

and with emissions emanating from outside the United States,

see 42 U.S.C. § 7509a, but provided no authorization for EPA

to waive NAAQS attainment requirements in the manner

requested by Doe Run. Even assuming the Clean Air Act was

ambiguous with regard to whether EPA was empowered to grant

other waivers, EPA’s interpretation of its authority under the

statutory scheme is permissible under Chevron step two, 467

U.S. at 843, and entitled to deference by the court. 

Accordingly, we deny the petitions.

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