American Forest and Paper Ass'n Inc. v. E.P.A., 01-1296.

• Decision Date: 28 June 2002
• Docket Number: No. 01-1296.,01-1296.
• Citation: 294 F.3d 113
• Parties: AMERICAN FOREST AND PAPER ASSOCIATION, INC., Petitioner v. ENVIRONMENTAL PROTECTION AGENCY, Respondent.
• Court: U.S. Court of Appeals — District of Columbia Circuit

294 F.3d 113

AMERICAN FOREST AND PAPER ASSOCIATION, INC., Petitioner v. ENVIRONMENTAL PROTECTION AGENCY, Respondent.

No. 01-1296.

United States Court of Appeals, District of Columbia Circuit.

Argued April 22, 2002.

Decided June 28, 2002.

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On Petition for Review of an Order of the Environmental Protection Agency.

Russell S. Frye argued the cause for the petitioner. Richard Wasserstrom was on brief. Christina B. Parascandola entered an appearance.

Andrew J. Doyle, Attorney, United States Department of Justice, argued the cause for the respondent. Patrice Simms and Patricia Embrey, Attorneys, United States Environmental Protection Agency, were on brief.

Before: GINSBURG, Chief Judge, HENDERSON and ROGERS, Circuit Judges.

Opinion for the court filed by Circuit Judge KAREN LeCRAFT HENDERSON.

KAREN LeCRAFT HENDERSON, Circuit Judge:

The American Forest and Paper Association, Inc. (Association), a national trade association of the forest, paper and wood products industry, seeks review of a notice published by the Environmental Protection Agency (EPA) denying the Association's petition to delete the substance methanol¹ from the list of "hazardous air pollutants" (HAPs) pursuant to section 112(b) of the Clean Air Act (CAA), 42 U.S.C. § 7412(b). See 66 Fed. Reg. 21,929 (May 2, 2001). Section 112(b)(3)(A) requires that EPA "either grant or deny the petition by publishing a written explanation of the reasons for the Administrator's decision." 42 U.S.C. § 7412(b)(3)(a).² We review EPA's notice of denial under the Administrative Procedure Act to determine whether it is "arbitrary, capricious, an abuse of discretion, or not in accordance with law." 5 U.S.C. § 706(2)(A).³ For the reasons set out below, we conclude EPA's explanation of its reasons for denying the delisting petition satisfies the statutory standard and we therefore deny the Association's petition for review.

I.

Section 112 requires EPA to set emission standards for "hazardous air pollutants." See 42 U.S.C. § 7412. In 1990 the Congress amended section 112 to establish a statutory list of HAPs, including methanol. See 42 U.S.C. § 7412(b)(1). Section 112(b)(2) requires that EPA "periodically review the list" and "publish the results thereof and, where appropriate, revise such list by rule, adding pollutants." 42 U.S.C. § 7412(b)(2). Section 7412(b)(3) provides that "any person may petition the Administrator to modify the list of hazardous air pollutants under this subsection by adding or deleting a substance." Id. § 7412(b)(3)(A). EPA is required (1) to "add a substance to the list upon a showing by the petitioner or on the Administrator's own determination that the substance is an air pollutant and that emissions, ambient concentrations, bioaccumulation or deposition of the substance are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects," id. § 7412(b)(3)(B); and (2) to "delete a substance from the list upon a showing by the petitioner or on the Administrator's own determination that there is adequate data on the health and environmental effects of the substance to determine that emissions, ambient concentrations, bioaccumulation or deposition of the substance may not reasonably be anticipated to cause any adverse effects to the human health or adverse environmental effects," id. § 7412(b)(3)(C).

The Association petitioned EPA to delist methanol in March 1996, relying on information it claimed shows exposure to methanol does not result in adverse effects to human health.⁴ "[T]o assess the potential for adverse human health effects due to inhalation exposure" to a particular substance EPA generally uses an "inhalation reference concentration" (RfC), 66 Fed. Reg. at 21,931, which "represents the estimated maximum exposure to a pollutant, as extrapolated from animal studies, that a human can tolerate continuously for 70 years without experiencing any adverse health effect," Chem. Mfrs. Ass'n v. EPA, 28 F.3d 1259, 1265 (D.C.Cir.1994). Because EPA had not yet established an inhalation RfC for methanol, the Association proposed a "safe exposure level" (SEL) for the substance, asserting that "exposures at or below the SEL can be expected to produce no adverse human health effects from lifetime inhalation exposures." 66 Fed. Reg. at 21,931. The Association derived its SEL from the "Rogers Study," which examined the effect on mice of methanol exposure for seven hours per day. The Association converted the No-Observable-Adverse-Effect-Level(NOAEL) derived from the Rogers Study to a human equivalent and adjusted it for interspecies extrapolation and for individual variation. The Association offered the resulting level of 83 milligrams per cubic meter (mg/m³) as the SEL for methanol. The Association further asserted that the highest predicted 24-hour average concentration of methanol from known sources is 3.65 mg/m³. Because this maximum exposure level was below its proposed SEL, the Association claimed that methanol exposure does not cause adverse effects and therefore should be delisted pursuant to section 112(b)(3)(C). The Association supplemented its petition periodically until EPA published a "notice of receipt of a complete petition" on July 19, 1999. See 64 Fed. Reg. 38,668. Subsequently the Association submitted additional materials addressing the "Burbacher Study," published in October 1999, which examined the effects of methanol inhalation on primates and which the Association contended supports delisting methanol.

Following a comment period, EPA issued its notice of denial on May 2, 2001. While generally approving the studies and the methodology the Association had used, EPA disagreed with the Association's analysis in three crucial respects.

First, EPA took issue with the Association's SEL, contending it should have incorporated a "duration adjustment," to account for the difference between the Rogers Study's 7-hour daily exposure and potential human daily exposure of 24 hours;⁵ and, in addition, it should have been derived using the "benchmark dose" (BMD) methodology⁶ rather than using the NOAEL methodology as the Association did. EPA determined that recalculating the SEL using a duration adjustment and the BMD methodology "would yield an SEL on the order of 4-6 mg/m³." 66 Fed. Reg. at 21,932. Because these values "are at the approximate midpoint of the values (0.3-30 mg/m³) that might be derived from the data of the Burbacher Primate Study," EPA concluded that "a range of 0.3 to 30 mg/m³ represents the most appropriate criterion for determining whether methanol emissions may reasonably be anticipated to cause adverse human health effects" and that "24-hour exposures below 0.3 mg/m³ are not likely to result in adverse human health effects." 66 Fed. Reg. at 21,935-36. EPA cautioned that it was "unable to make a more precise determination at this time regarding the exposure levels at which adverse effects are likely to occur." 66 Fed. Reg. at 21,936.

Second, EPA challenged the Association's maximum 24-hour exposure level as too low. Based on the data initially submitted by the Association, EPA suggested that the "maximum 24-hour exposures to methanol emissions could be in the range of 2 to 7 mg/m³, but that such exposures may not reasonably be expected to exceed 7 mg/m³." 66 Fed. Reg. at 21,939.

Third, EPA determined that, contrary to the Association's contention, the Burbacher Study in fact supports retaining methanol on the list because it revealed several possible adverse health effects, namely, a decrease in gestation time, an increase in the number of required caesarian-section births, and, in prenatally exposed offspring, instances of a "severe wasting syndrome," concentration-related delay in sensorimotor development and lower performance on an infant intelligence test. 66 Fed. Reg. at 21,932-33. EPA concluded that, "based on the weight of evidence, ... there are reproductive and developmental health consequences following exposure to methanol in primates (Burbacher et al.) and that these effects should be considered relevant to potential risks in humans." 66 Fed. Reg. at 21,935.

Because EPA's maximum exposure level exceeded the floor of its SEL range and because the Burbacher Study, as EPA construed it, indicated potential adverse effects from methanol, EPA determined it "c[ould] not conclude that there are adequate data to determine that emissions of methanol may not reasonably be anticipated to cause any adverse effects to human health." 66 Fed. Reg. at 21,929.

The Association petitioned for review of the notice of denial on July 2, 2001.

II.

The Association raises a series of challenges to the EPA's notice of denial. We find none of them persuasive.

First, the Association asserts EPA misinterpreted the statutory standard for delisting a substance to permit it to rely on mere speculation about adverse effects. Section 112(b)(3)(C) requires that EPA delist an HAP "upon a showing by the petitioner or on the Administrator's own determination that there is adequate data on the health and environmental effects of the substance to determine that emissions, ambient concentrations, bioaccumulation or deposition of the substance may not reasonably be anticipated to cause any adverse effects to the human health or adverse environmental effects." 42 U.S.C. § 7412(b)(3)(C). EPA construed the statutory language to impose a "burden ... on a petitioner to demonstrate that the available data support an affirmative determination that emissions of a substance may not be reasonably anticipated to result in adverse effects on human health or the environment" so that "EPA will not remove a substance from the list of HAP based merely on the inability to conclude that emissions of the substance will cause adverse effects on human health or the environment." 66 Fed. Reg. at 21,930. We review EPA's construction of the statutory...