Opinion ID: 744479
Heading Depth: 2
Heading Rank: 1

Heading: The General Objections.

Text: 31
32 First, appellants argue that the EPA based its final listing decisions on toxicity criteria inconsistent with the criteria specified in EPCRA § 313. They point out that Congress set a high evidentiary standard for listing. In the subsection relevant to appellants' specific objection, the statute specifies that the EPA may add a chemical to the TRI based on chronic health effects only where there is sufficient evidence to establish that the chemical is known to cause or can reasonably be anticipated to cause ... serious or irreversible ... chronic health effects in humans. 42 U.S.C. § 11023(d)(2)(B)(ii)(IV). In urging that the EPA did not comply with these criteria, appellant CMA acknowledges the EPA's claim in its final rule that its senior scientists conducted a thorough hazard evaluation in determining by the weight of the evidence whether each chemical met the listed criteria. However, appellants go on to remind us that [s]tating that a factor was considered ... is not a substitute for considering it. Getty v. Federal Sav. & Loan Ins. Corp., 805 F.2d 1050, 1055 (D.C.Cir.1986). They argue that we should not accept at face value the EPA's claim to have conducted the evaluation, but should make a searching and careful inquiry to determine if the agency did in fact consider the necessary factors. Id. (quoting Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416, 91 S.Ct. 814, 823-24, 28 L.Ed.2d 136 (1971)). Appellants contend that our review of the record in the present case will reveal no support for the proposition that the EPA actually did conduct the hazard evaluation or weight-of-the-evidence assessment. They argue that this case is analogous to AFL-CIO v. OSHA, 965 F.2d 962 (11th Cir.1992), in which the Eleventh Circuit considered an Occupational Safety and Health Administration rulemaking that established permissible exposure limits (PELs) for 428 chemicals. In that case the Eleventh Circuit vacated all the PELs because OSHA inadequately articulated its reasons for their promulgation, merely cit[ing] a few studies and then establish[ing] a PEL without explaining why these studies mandated the agency's choice. Id. at 976. 33 CMA joins its argument that the EPA failed to comply with statutory standards with a contention that the Administrator also arbitrarily and capriciously failed to comply with the Guidelines. While this is conceptually separate from the statutory argument, CMA almost makes the two arguments one by contending that the Administrator telescoped the two-step Guideline analysis into the first step and made its decision to list a chemical based solely on what CMA calls the overly broad toxicity criteria applied in the first step of the Guidelines without either determining whether the toxicity of the chemical met the more demanding standards of the statute, or conducting the hazard analysis required in step two of the Guidelines. Whether this is viewed as a failure to comply with the statute, or an arbitrary and capricious disregard of its own procedures, or both, if CMA is correct, then the district court erred in granting summary judgment in favor of the Administrator, and we must reverse. However, we hold that CMA is not correct. 34 In reaching this conclusion, we are guided by one of the cases relied upon by CMA. In Citizens to Preserve Overton Park, the Supreme Court held that a reviewing court is not to substitute its judgment for that of the agency. 401 U.S. at 416, 91 S.Ct. at 824. Instead, we only determine whether the decision was arbitrary and capricious, or otherwise contrary to law. In so doing, we examine whether the decision was based on the relevant factors and was not a clear error of judgment. Id. In conducting this review, we show considerable deference, especially where the agency's decision rests on an evaluation of complex scientific data within the agency's technical expertise. See, e.g., New York v. Reilly, 969 F.2d 1147, 1152 (D.C.Cir.1992). As we have said, we review scientific judgments of the agency not as the chemist, biologist, or statistician that we are qualified neither by training nor experience to be, but as a reviewing court exercising our narrowly defined duty of holding agencies to certain minimal standards of rationality. Ethyl Corp. v. EPA, 541 F.2d 1, 36 (D.C.Cir.), cert. denied, 426 U.S. 941, 96 S.Ct. 2662, 49 L.Ed.2d 394 (1976). This review of the factual determinations and policy decisions of an agency is governed by the APA, which directs us to set aside an agency's decision only if it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 5 U.S.C. § 706(2)(A). 35 Moreover, insofar as the agency's determination amounts to or involves its interpretation of EPCRA, a statute entrusted to its administration, we review that interpretation under the deferential standard of Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Under that standard, in order to hold erroneous the EPA's application of EPCRA in assessing the hazard risk, we would have to conclude that its interpretation either ran athwart a clear mandate of Congress, or was an unreasonable one. On the present record, we agree with the district court that appellants have established neither unlawfulness, arbitrariness, capriciousness, nor a misinterpretation of the statute. 36 CMA's combined statutory/Guidelines argument begins with the proposition that the EPA departed from the high evidentiary standard set by Congress for listing and instead relied on the less demanding toxicity criteria at the first step of the Guidelines. Those criteria are broader than the statute's, and therefore, allowing them to govern is inconsistent with the statute. This argument would be a colorable one if the EPA had done just what appellants set forth and then listed chemicals based on the results of that activity, but that is not in fact what occurred. Instead, the broader toxicity screen was but the first step. It allowed the agency to make the above-described division of the chemicals into three parts. Only as to the chemicals found insufficient for listing did the agency stop with the toxicity screen. Granted, the agency's original misleading nomenclature may have made it seem that it had found the evidence as to the other categories of chemicals to be sufficient or that the evidence may be sufficient, but that was merely nomenclature. 37 Indeed, as noted above, the EPA in the preamble to the proposed rule announced the renaming of the screening categories to the more descriptive terms high, medium, and low priority. As to those chemicals which survived the first screening, whether classified as of high or medium priority, or according to the earlier, misleading nomenclature, the EPA went on to conduct further proceedings designed to achieve compliance with the more rigorous demands of the statute. This further process is summarized in documents included in the administrative record. See 59 Fed.Reg. 1788, 1789-90. Although the exact applications of step-two analysis varied with the nature of the data available on specific chemicals, typically the EPA's contractor reviewed the data as to those chemicals surviving the first screen, and senior scientists of the EPA reviewed the contractor's report and the existing data in what was called a HERD review (for Health and Environment Review Division of EPA's Office of Pollution Prevention and Toxics). Only where a case-by-case review of each chemical in one of the two categories revealed that there was sufficient evidence to establish that the candidate chemical met the statutory criteria for addition to EPCRA § 313, id. at 1790, did the Administrator add the chemical to the TRI. 38 The AFL-CIO v. OSHA decision upon which appellants rely does not suggest a contrary result. As always, of course, the question of sufficiency of an agency's stated reasons under the arbitrary and capricious review of the APA is fact-specific and record-specific. That OSHA had not given sufficient reasons under a different statute applying a different (substantial evidence) standard of review on a different factual record would not compel a similar result on our part even if that case were a binding precedential decision from our own circuit, which, of course, it is not. More specifically, from the Eleventh Circuit's decision, it appears that OSHA's failure to give reasons in that case was systemic and purposeful. Here, as we have already noted, the EPA undertook an on-the-record review of the data as to each candidate chemical. While we might describe the record of some of the chemical-by-chemical reviews as brief or sketchy, that would not necessarily be pejorative. That a standard, such as the statutory standard in this case, is strict, does not require that the evidence to meet it be voluminous, and especially does not require that it be voluminously recorded. CMA's generic challenge to the sufficiency of the listing process fails. Insofar as appellants contend that the record is insufficient with respect to specific chemicals, we will address those contentions in our chemical-by-chemical analysis infra. 39
40 Appellants, led by NPG, object to the refusal of the EPA to assess the likelihood of exposure of humans to each candidate chemical before listing it on the TRI as a chemical that is known to cause or can reasonably be anticipated to cause the undesirable consequences listed in42 U.S.C. § 11023(d)(2)(B) & (C). Appellants argue first that the EPA's failure to consider exposure is a violation of the statute, and, alternatively, that the EPA's adoption of the policy of nonconsideration amounts to an unlawfully adopted legislative rule. Neither argument is meritorious. 41
42 NPG, in an argument adopted by the other appellants as to other chemicals, contends that the EPA failed to comply with the governing statute in adding NMP (N-Methyl-2-Pyrrolidone) to the TRI. NMP is a general purpose solvent used in paint stripping, lube oil extraction, and several industrial and agricultural applications. According to appellants, and undisputed by the EPA, NMP is chemically and heat stable, and has a low vapor pressure (that is, does not readily change from liquid to gas forms), making inadvertent atmospheric release unlikely. NMP is expensive and easily recycled, so that facilities have both the economic incentive and technical capability to minimize release into the environment. If released into water, NMP, being readily biodegradable, quickly breaks down into harmless and naturally occurring substances. Therefore, appellants contend, human exposure to a release of the chemical in a sufficiently large quantity to result in an adverse effect is highly unlikely. Appellants assert that in the face of that unlikelihood, the EPA violated the statutory standard by listing NMP as a TRI chemical that can reasonably be anticipated to cause adverse reproductive and developmental effects under subsection (B). 43 Appellants' argument is that no matter how toxic NMP might be, Congress could not have contemplated that such a chemical would be listed under the TRI as no substance can reasonably be anticipated to cause adverse health effects in humans unless it is likely to come into contact with humans (e.g., escape) in sufficiently large quantities to produce such adverse effects. Indeed, NPG contends that the EPA's contrainterpretation fails at the first step of the Chevron analysis: that is, that it runs contrary to the unambiguously expressed intent of Congress. In the view of NPG, by using the quoted language of reasonable anticipation, Congress must have intended the EPA to consider likelihood of exposure in making listing decisions. We disagree. 44 It is not the case that the congressional language mandating listing of a chemical that is known to cause or can reasonably be anticipated to cause in humans the enumerated adverse effects unambiguously incorporates the likelihood of contact between humans and the chemical. A simple analogy quickly refutes NPG's argument that the language is unambiguous. Consider a herpetologist and a student contemplating a reptile imprisoned in a glass cage. The student asks, Can that snake's bite reasonably be anticipated to cause death in humans? The scientist replies, Yes. The scientist is not commenting on the likelihood of the serpent's escape, only the toxicity of its venom. Concededly, his answer could be taken to mean, Yes, it is likely that this creature will escape, bite someone, and kill them. But that is certainly not the unambiguous purport of his words. Even so is the statutory language of Congress. It is conceivable that Congress may have contemplated release in its phrasing of the standard, but that is certainly not unambiguously the case. Therefore, under Chevron, as the wording of the statute is at most ambiguous, the most that can be required of the administering agency is that its interpretation be reasonable and consistent with the statutory purpose. Chevron, 467 U.S. at 843, 104 S.Ct. at 2781-82. The EPA's interpretation of the statutory phrase is not only reasonable, but indeed well justified. 45 Although we might simply say that the agency's interpretation of the words of Congress is reasonable on its face, in the same way that the student might reasonably understand the scientist to be describing the venomous characteristics of the snake, the EPA offers us stronger and more specific support for its interpretations. Section 313(d)(2) of EPCRA has three subheadings. Subheading (A) provides for listing based on causation of significant adverse acute human health effect at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases. 42 U.S.C. § 11023(d)(2)(A). Subheading (B), the one implicated in the NMP controversy, provides for listings based on causation in humans of cancer, teratogenic effects, or serious or irreversible listed adverse effects including the provision implicated here: other chronic health effects. 42 U.S.C. § 11023(d)(2)(B). Subheading (C) provides for listing based on causation, as a result of toxicity, environmental persistence, or bioaccumulation, of a significant adverse effect on the environment.... 42 U.S.C. § 11023(d)(2)(C). 46 Neither (B) nor (C) contains the language found in (A) requiring that causation be under the described circumstances of concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases. If that language were present in the other two subsections, NPG's argument that Congress intended the EPA to consider the likelihood of accidental escape or other contact with humans would be much stronger--perhaps irrefutable. Indeed, if that language were in the statute, the EPA might well have interpreted the statute as appellants desire. But the language is not in the relevant subsections of the statute. The EPA reminds us that where Congress includes particular language in one section of the statute but omits it in another, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion. Keene Corp. v. United States, 508 U.S. 200, 208, 113 S.Ct. 2035, 2040, 124 L.Ed.2d 118 (1993) (internal punctuation and citation omitted). Thus, it is, to say the least, not unreasonable for the EPA to have concluded that Congress meant to include consideration of the likelihood of human exposure to chemicals governed by (A) but not those governed by (B) or (C). We therefore reject appellants' statute-based argument. 47
48 Correctly anticipating that we might hold the EPA's interpretation of (B) and (C) not inconsistent with the statute on the question of exposure, appellants put forth a fallback position. They argue that even if the interpretation was not substantively erroneous, its adoption was procedurally flawed. 49 The EPA expressed its policy regarding consideration of exposure in the preamble to its final rule. 59 Fed.Reg. 61,432, 61,440-42. In that preamble, the agency notes that it has received many comments concerning the issue of whether the statutory criteria include an implicit exposure and thus risk component. Id. at 61,441. The agency then states that it has reviewed its positions in [that] area, and expresses its agree[ment] with many of the commentators that there are limited circumstances under which it is appropriate ... to consider exposure factors for listing decisions under § 313(d)(2). It lists the circumstances under which exposure considerations are appropriate as including only determinations under subsection (A), under subsection (B) for chemicals of low to moderately low toxicity, and those under subsection (C) that are low or moderately ecotoxic without certain described serious adverse effects. 50 NPG mounts a two-front assault on the statements regarding exposure analysis in the preamble. First, it contends that the EPA's position amounts to a change in policy without a reasoned justification. Second, it argues that the preamble is a legislative rule that had not been properly promulgated. On review, we uphold the district court's determination that the EPA's policy expressed in the preamble survives both challenges. 51 First, NPG argues that the EPA's exposure policy pronouncement in its preamble constituted a change in agency policy. Appellants remind us that an agency is obligated not to depart without reasoned explanation from its prior conclusions. National Ass'n for Better Broadcasting v. FCC, 849 F.2d 665, 669 (D.C.Cir.1988) (internal punctuation omitted). This is undeniably correct. As the Supreme Court stated in an analogous context, an agency changing its course by rescinding a rule is obligated to supply a reasoned analysis for the change beyond that which may be required when an agency does not act in the first place. Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42, 103 S.Ct. 2856, 2866, 77 L.Ed.2d 443 (1983). Were the EPA to abandon a long-held exposure policy and take a new direction we would, as urged, require a thorough explanation of its reasons for doing so. Yet, the EPA's pronouncement in its preamble of its exposure policy is not a change in course. With one exception, the EPA has consistently stated, as it does in this rulemaking, that it will consider exposure under subsection (B) only when the chemical was of low to moderately low toxicity. The EPA concedes that in one case the agency denied a petition to add inorganic fluorides to the list based in part on the insignificance of industrial releases of the chemicals. The agency stated, EPA has concluded that potential exposure must be a consideration in making decisions to add chemicals to the list. 52 Fed.Reg. 20,142, 20,145 (May 29, 1987). While some inorganic fluorides cause serious chronic health effects at high doses, the EPA determined that the exposure required for such effects to occur was not likely to result. 52 Whatever the reasons for the EPA's determination in that case, the agency has long maintained that it would consider exposure under subheading (B) only for low toxicity chemicals. The inorganic fluorides petition was denied over ten years ago. Since that time, the agency has made several dozen listing and delisting decisions under EPCRA. The inorganic fluorides case was the only instance in which the agency articulated a policy contrary to the one explicated in this rulemaking. Under these circumstances we cannot say that the agency has departed from prior practice in a way that requires more explanation than was provided. If anything, the inorganic fluorides case constituted such a departure, but that is not before us. 53 We also reject NPG's argument that the exposure policy amounts to a legislative rule that should have been issued for notice and comment rulemaking under 5 U.S.C. § 553. The APA excludes general statements of policy from the requirements of section 553. The precise distinction between a general statement of policy and a legislative rule is often elusive, but in seeking it we have found useful a two-part inquiry put forth in American Bus Ass'n v. United States, 627 F.2d 525 (D.C.Cir.1980). There we said that, first, a general statement is one that does not impose any rights and obligations and, second, that a policy statement generally leaves the agency and its decisionmakers free to exercise discretion. Id. at 529. See also Community Nutrition Inst. v. Young, 818 F.2d 943, 946 (D.C.Cir.1987). A legislative rule, in contrast, is one that: (1) supplements a statute; (2) effect[s] a change in existing law or policy; or (3) grant[s] rights, impose[s] obligations, or produce[s] other significant effects on private interests. National Family Planning & Reprod. Health Ass'n v. Sullivan, 979 F.2d 227, 237-38 (D.C.Cir.1992). See also Batterton v. Marshall, 648 F.2d 694, 701-02 (D.C.Cir.1980); Chamber of Commerce v. OSHA, 636 F.2d 464, 469 (D.C.Cir.1980). We will also consider an agency's characterization of its own actions, although that characterization is not dispositive. See Telecommunications Research and Action Center v. FCC, 800 F.2d 1181, 1186 (D.C.Cir.1986). Applying these principles we conclude that the EPA's exposure policy was exempt from the notice and comment requirements of section 553. The EPA's exposure policy merely informed the public that the agency would exercise its discretion by considering exposure only for low toxicity chemicals. The EPA did not thereby curtail this discretion; it did nothing more than clarify its own position. The policy does not impose rights or obligations or bind the agency to a particular result. Chemicals of low toxicity may be added despite the policy, just as chemicals of moderate or high toxicity are not necessarily added because of it. 54 Having disposed of appellants' general objections to the rulemaking, we will address the chemical-specific objections in turn.