The opinion of the court was delivered by: KESSLER
Each of four Plaintiffs, Troy Corporation ("Troy"), NMP Producers Group ("NMP"), National Oilseed Processors Association ("NOPA"), and Chemical Manufacturers Association ("CMA"), brings a separate action against the Environmental Protection Agency ("EPA" or "Agency") pursuant to the Administrative Procedure Act ("APA"), 5 U.S.C. § 706(2)(A), on the grounds that EPA's addition of each Plaintiff's chemical or chemicals to the Toxic Release Inventory ("TRI") list was arbitrary and capricious, an abuse of discretion, and contrary to law.
Each Plaintiff seeks a final order vacating the final decision of the EPA to list the chemical or chemicals pursuant to § 313 of the Emergency Planning and Community Right-To-Know Act of 1986 ("EPCRA"), 42 U.S.C. § 11023.
This matter is before the Court upon Plaintiffs' Motions for Summary Judgment and Defendants' Cross-Motions for Summary Judgment pursuant to Federal Rule of Civil Procedure 56. The Court has considered the Motions, the Oppositions, the Replies, the oral arguments in open court on March 27, 1996, the applicable statutory and case law, and the voluminous record submitted in each of the four cases. For the reasons discussed below, the Court concludes that Plaintiffs' Motions for Summary Judgment must be denied, and that Defendants' Cross-Motions for Summary Judgment must be granted.
State and local governments, as well as the public at large, are entitled to access information concerning potential chemical hazards in their communities. That is the central premise underlying the Emergency Planning and Community Right-To-Know Act ("EPCRA"), codified at 42 U.S.C. §§ 11001-11050 and signed into law on October 17, 1986, as Title III of the Superfund Amendments and Reauthorization Act of 1986, Pub. L. No. 99-499, 100 Stat. 1613, 1629. The primary purpose of the law is to encourage state and local planning for spills or releases of toxic or hazardous chemicals. 42 U.S.C. § 11001.
of EPCRA mandates that facilities manufacturing, processing or using certain toxic chemicals report annually on the presence of those chemicals at the facility, the uses of the chemicals, an estimate of the maximum amounts of the chemicals present at the facility at any time, methods of disposal and treatment of waste, and the extent to which those chemicals are being released into the environment. 42 U.S.C. § 11023(g). The list of toxic chemicals subject to reporting under § 313 is known as the Toxic Release Inventory ("TRI") list. Notably, EPCRA does not restrict the manufacture, processing, use or disposal of any chemical; it is simply a reporting statute which requires facility owners or operators to provide EPA and state governments with information.
42 U.S.C. § 11023(a). EPA and state governments, in turn, make this information available to local governments and citizens in the community, who may then develop appropriate emergency response plans as required under Section 303 of EPCRA. See 42 U.S.C. § 11023(h) and (j); 59 Fed. Reg. 1788 (col. 3) (Jan. 12, 1994).
When Congress enacted EPCRA in 1986, it directly placed 309 individual chemicals and 20 chemical categories on the TRI list. 42 U.S.C. § 11023(c). These chemicals came from two existing lists of toxic chemicals: the Maryland Chemical Inventory Report List of Toxic or Hazardous Substances, and the New Jersey Environmental Hazardous Substance List. 59 Fed. Reg. at 1788 (col. 3).
Congress provided that additions may be made to the TRI list in the following manner: First, under § 313(e), 42 U.S.C. § 11023(e), either a private party or a State Governor may petition EPA to add chemicals to or delete chemicals from the TRI list. Within 180 days of receiving such a petition, EPA must either (1) initiate a rulemaking to add or delete the chemical, or (2) publish an explanation of why the petition is denied. 42 U.S.C. § 11023(e)(1).
Second, on its own initiative, EPA "may by rule add or delete a chemical from the [TRI list] at any time." 42 U.S.C. § 11023(d)(1). Congress left to EPA's discretion the timing and manner of selection of candidate chemicals to be considered for listing under the statutory criteria. The criteria for listing are the same regardless of whether listing is triggered by a petition or an EPA rulemaking. 42 U.S.C. § 11023(d)(2) and (e). The basic requirement for addition of chemicals to the TRI list is a finding by the Administrator that, in her judgment, "there is sufficient evidence to establish any one of" three criteria for listing. 42 U.S.C. § 11023(d)(2).
The first criterion provided in the statute is that EPA may list chemicals that are known to cause or can reasonably be anticipated to cause significant adverse acute human health effects 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).
The second statutory criterion is that EPA may list chemicals that are known to cause or can reasonably be anticipated to cause in humans cancer, teratogenic effects (i.e., developmental malformations), or serious or irreversible reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects. See 42 U.S.C. § 11023(d)(2)(B).
The third statutory criterion is that EPA may list chemicals that are known to cause or can reasonably be anticipated to cause, because of their toxicity alone, or their toxicity and persistence in the environment, or their toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment. See 42 U.S.C. § 11023(d)(2)(C).
In enacting Section 313, Congress provided that EPA may list a chemical even when its effects cannot be proven to a scientific certainty. The statute mandates that EPA base its listing decisions under Section 313 "on accepted scientific principles or laboratory tests, or appropriately designed and conducted epidemiological or other population studies, available to the Administrator." 42 U.S.C. § 11023(d).
III. EPA's Screening Process
After seven years of administering EPCRA, EPA concluded in 1993 that the TRI list covered only a relatively small portion of the chemicals potentially of concern to EPA and the public. See 59 Fed. Reg. at 1788-89. In order to develop candidates for addition to the TRI list, EPA identified ten lists of chemicals and two lists of carcinogens. 59 Fed. Reg. 61,432. Faced with 12 lists containing over 1500 chemicals
, as well as the Agency's limited resources, EPA developed and applied screening procedures
to eliminate some chemicals from consideration before beginning the rulemaking.
First, EPA excluded a number of the chemicals for practical reasons, such as the fact that they were already on the TRI list or that they had previously been considered and rejected for listing in two previous rulemakings triggered by Section 313(e) petitions. 59 Fed. Reg. 1789. Once this was done, EPA had narrowed the list to 1031 potential candidates for the rulemaking process.
Second, EPA subjected most of the remaining 1031 chemicals to a "production volume screen" and a "toxicity screen." 59 Fed. Reg. 1789-90. Under the production volume screen, EPA determined whether each chemical was manufactured, processed, or used in volumes above the statutory reporting thresholds established in Section 313(f). 42 U.S.C. § 11023(f). EPA used the toxicity screen to determine whether the chemicals manifested acute human health effects, cancer, other chronic human health effects, or ecological effects. This screen was based on readily available toxicity data and involved a "quick look" to identify chemicals that did not warrant further consideration. 59 Fed. Reg. 1789. EPA used the toxicity data to place each chemical in one of three categories: high priority, medium priority, or low priority. 59 Fed. Reg. 61,432-33.
As a result of the two screens, there was a significant narrowing of the list of chemicals to be considered by EPA in the rulemaking process. As a result of their "low priority" ranking, the narrowing process culminated in the exclusion of 648 chemicals from the rulemaking. 59 Fed. Reg. 1789-90. The remaining 383 chemicals became candidates for listing and entered the rulemaking phase.
IV. The Present Rulemaking
EPA reviewed, in a full "hazard evaluation," each of the remaining 383 chemicals to determine whether the scientific evidence supported its listing under one or more of the three criteria set forth in Section 313(d)(2). 42 U.S.C. § 11023(d)(2). The hazard evaluation involved a review of available studies and other information to determine (1) whether the chemical exhibits one or more of the toxic effects that justify addition to the TRI list, and (2) the dose required to create that effect. 59 Fed. Reg. 1790. In the hazard evaluation, EPA also assessed the scientific studies' reliability by analyzing the assumptions and methodologies used in conducting the studies. Id.
When no single study was sufficient to determine whether a chemical had toxic effects, the hazard evaluation included a "weight-of-evidence" evaluation. That evaluation involved an assessment of the available studies and information, both positive and negative, about the chemical. In undertaking this evaluation, EPA tried to determine whether the collective results of the individual studies would form a reasonable basis for reaching a conclusion on toxicity. 59 Fed. Reg. 1790.
EPA based its hazard evaluation of the chemicals, in most instances, on information in EPA's Integrated Risk Information System ("IRIS"). 59 Fed. Reg. 61,444-45. IRIS is an EPA-created database,
which contains EPA's consensus positions
on the potential adverse human health effects of approximately 500 chemicals. Announcement of Availability of IRIS Background Paper ("IRIS Background paper"), 58 Fed. Reg. 11,490. Developed in 1986, IRIS offers chemical-specific hazard and risk information, which is the result of periodically updated, comprehensive hazard assessments conducted by panels of senior EPA scientists. See Report of the IRIS Quality Action Team on External Peer Review and Public Involvement at 5-6; IRIS is generally accepted as a reliable source of information on the potential hazardous effects of those chemicals that are included in IRIS. See 58 Fed. Reg. 11,490.
In January, 1994, after completing the hazard evaluation on the 383 candidate chemicals, EPA published a proposed rule adding chemicals to the TRI list. Of the 383 chemicals considered in the rulemaking, 313 were found to meet the statutory criteria and proposed for listing in EPA's proposed rule. 59 Fed. Reg. 1793.
Following receipt of comments on the proposed rule, EPA considered the arguments and information submitted by the Plaintiffs and others and responded to those comments. As a result of the comments, EPA decided to defer action on 41 chemicals to a future rulemaking. 59 Fed. Reg. 61,439. EPA also decided that there was insufficient information to justify the listing of three chemicals proposed for addition to the TRI list. 59 Fed. Reg. 61,466. Finally, EPA added a category of 20 chemicals, which had included three that had been proposed for listing individually. Thus, of the 313 chemicals that were proposed for listing, 286 chemicals were added to the TRI list in November, 1994 in the final rule.
EPA's administrative record is voluminous. For example, EPA's revised Draft Hazard Assessment Guidelines for Listing Chemicals on the Toxic Release Inventory of May 26, 1992, comprised thirty-two single-spaced pages; EPA's Guidelines for Developmental Toxicity Risk Assessment comprised twenty-eight pages in the Federal Register, see 56 Fed. Reg. 62,798-63,826; the proposed rule itself comprised seventy pages in the Federal Register, see 59 Fed. Reg. 1788-1859; EPA submitted a comprehensive Response to Comments Document; and the final rule comprised 53 pages in the Federal Register, see 59 Fed. Reg. 61,432-85. That sampling only begins to capture the weighty paper trail before the Court.
Further, EPA considered and responded to countless comments throughout the rulemaking process. See, e.g., 59 Fed. Reg. at 61,439-71. EPA responded in detail to comments which included concern about the validity of the screening procedure, the appropriateness of the Draft Hazard Assessment Guidelines, the need for risk assessments and exposure consideration before adding a chemical to the TRI list, the statutory authority to list chemical categories, numerous policy issues, and general technical matters. The record is extensive, ponderous, and sweeping.
Finally, while the actual rulemaking began with the issuance of the proposed rule on January 12, 1994, and ended with the issuance of the final rule on November 30, 1994, consideration of these issues actually began back in May, 1992, when the Revised Draft Hazard Assessment Guidelines for Listing Chemicals on the Toxic Release Inventory was issued. Thus, the issues raised by Plaintiffs in these lawsuits have been under scrutiny in the administrative process for more than two years.
All parties recognize that the Court is bound by a highly deferential standard of review for agency action. Under the Administrative Procedure Act ("APA"), an agency's action may be set aside only if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A). In making this finding, the Court "must consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment." Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416, 28 L. Ed. 2d 136, 91 S. Ct. 814 (1971). The Court may not substitute its judgment for that of the agency. Id. The Court's role is to ensure that the agency's decision was based on relevant factors and not a "clear error of judgment." Id. If the "agency's reasons and policy choices . . . conform to 'certain minimal standards of rationality' . . . the rule is reasonable and must be upheld." Small Refiner Lead Phase-Down Task Force v. EPA, 227 U.S. App. D.C. 201, 705 F.2d 506, 521 (D.C. Cir. 1983) (citation omitted). This standard presumes the validity of agency action. Ethyl Corp. v. EPA, 176 U.S. App. D.C. 373, 541 F.2d 1, 34 (D.C. Cir. 1976) (en banc), cert. denied, 426 U.S. 941 (1976).
An agency's interpretation of a statute should be upheld as long as it is a permissible interpretation. Chevron USA Inc. v. National Resources Defense Council, Inc., 467 U.S. 837, 843-45, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984). Courts also give a high degree of deference to agency actions based on an evaluation of complex scientific data within the agency's technical expertise. See Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103, 76 L. Ed. 2d 437, 103 S. Ct. 2246 (1983); NRDC v. EPA, 263 U.S. App. D.C. 231, 824 F.2d 1211, 1216 (D.C. Cir. 1987) (citing NRDC v. EPA, 259 U.S. App. D.C. 5, 812 F.2d 721, 725 (D.C. Cir. 1987))("It is not for the judicial branch to undertake comparative evaluations of conflicting scientific evidence.")
It is hard to imagine a case that fits more squarely within these principles than the four cases before the Court. The EPA rulemaking involves consideration of complex scientific data and sophisticated analysis fit primarily for those tutored in the field. Few courts can and no court should engage in an independent comparative evaluation of conflicting scientific evidence. Where the agency decision turns on issues requiring the exercise of technical or scientific judgment, it is essential for judges to "look at the decision 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., 541 F.2d at 36-37.
VI. Issues Common to the Rulemaking
All Plaintiffs contend that the rulemaking is fatally flawed because EPA did not consider exposure information in its listing decisions.
Plaintiffs' general challenge can be broken down into two major arguments. First, they argue that EPA must, as a matter of law, consider exposure because the language "chronic health effects" in Section 313(d)(2)(B) implies consideration of "risk," which in turn requires weighing exposure in the analysis. Second, Plaintiffs argue that even if EPA does have discretion under the statute whether or not to consider exposure, it must exercise that discretion in a non-arbitrary manner, and fully justify on the record how it exercised its discretion. Plaintiffs contend that in the present rulemaking, EPA has neither articulated a meaningful standard to explain when it will consider exposure, nor provided a record that reveals whether EPA has applied its alleged standard reasonably.
1. Chevron Analysis: Does EPA Have Discretion to Include or Exclude Consideration of Exposure in Listing Decisions?
The first issue -- whether EPA must, as a matter of law, consider exposure in listing decisions -- is a question of statutory interpretation, governed by the Supreme Court's landmark decision in Chevron, 467 U.S. 837, 81 L. Ed. 2d 694, 104 S. Ct. 2778. Under the rule stated in Chevron, a court must follow a two-step test. First, a court must look to the plain meaning of the statute to determine whether Congress has spoken to the precise question at issue. Chevron, 467 U.S. at 842. If it has, then the court must give effect to the clearly expressed intent of Congress. Id. at 842-43. If the statute is silent or ambiguous on the issue, however, the agency's interpretation should be upheld so long as it is a "permissible construction of the statute." Id. at 843. A court "need not conclude that the agency construction was the only one it permissibly could have adopted to uphold the construction, or even the reading the court would have reached if the question originally had arisen in a judicial proceeding." Id. at 843 n.11.
Under Section 313 of EPCRA, EPA may list a chemical in one of three instances. Under Section (d)(2)(A), the Agency may list a chemical if it "is known to cause or can reasonably be anticipated to cause acute human health effects . . . at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently occurring, releases." 42 U.S.C. § 11023(d)(2)(A). Thus, under the "acute effects" basis for listing, EPA must consider both (1) the effect that the chemical causes and (2) the likelihood of exposure to the chemical ("concentration levels" beyond facility site boundaries).
By contrast, the two other listing criteria (Section (d)(2)(B) for "chronic health effects" and Section (d)(2)(C) for "environmental effects") only require EPA to conclude that the chemical is "known to cause or can reasonably be anticipated to cause" chronic human or environmental effects, that is, they require EPA to consider only the effects the chemical causes. These provisions do not contain the same specific language pertaining to the "concentration levels that are reasonably likely to exist beyond facility site boundaries" or any other language suggesting that EPA must consider the circumstances or likelihood of exposure. 42 U.S.C. § 11023(d)(2)(B) and (C).
While these differences strongly suggest that Congress intended that exposure must be considered under Section (d)(2)(A) but not under Sections (d)(2)(B) or (C), it cannot be said that Congress spoke with such clarity that the issue can be fully resolved by looking only at the plain meaning of the statute. The Court therefore proceeds to the second step of the Chevron analysis.
Under Chevron's second step, the Court must uphold an agency's interpretation so long as it is a "permissible construction of the statute." Chevron, at 843. Here, EPA argues that the logical and reasonable interpretation of the differences in statutory language just discussed is that Congress required consideration of exposure when listing a chemical under the "acute effects" prong in subsection (A), but did not mandate such consideration of exposure when listing a chemical under the "chronic effects" or "environmental effects" standards in subsections (B) or (C).
This is both a reasonable and permissible construction of the statute, and under Chevron, the Court must accept the Agency's reading. The Court concludes, therefore, that EPCRA does not mandate that EPA consider exposure under Section 11023(d)(2)(B), and that EPCRA allows the Agency discretion to include or exclude exposure information in making listing decisions under that section.
2. Did EPA Exercise Its Discretion Reasonably?
Even though Congress gave EPA the discretion to not consider exposure in its listing decisions, it must not exercise that discretion in an arbitrary or unreasonable fashion. Chemical Manufacturers Ass'n v. EPA, 899 F.2d 344, 359 (D.C. Cir. 1990).
The Agency argues generally that, in the exercise of its discretion, it has elected to consider exposure only in limited circumstances. Specifically, when EPA's hazard assessment shows that a chemical exhibits only low or moderately low toxicity, EPA will consider the potential for exposure in making a listing decision. Conversely, where EPA's hazard assessment reveals that a chemical's toxicity is high or moderately high, EPA does not consider exposure, and will list the chemical based solely on its toxic effect. 59 Fed. Reg. 61,441.
This policy, the Agency argues, has been consistently applied since EPCRA's passage. The instances cited by Plaintiff where EPA has considered exposure in listing decisions do not demonstrate otherwise. Rather, argues EPA, those listings and delistings are simply examples where EPA chose to consider exposure, because the chemicals at issue were of low toxicity.
Moreover, EPA asserts that it explained adequately on the record that it chose to not consider exposure in this rulemaking because all of the chemicals proposed for listing under Section 313(d)(2)(B) were of "high to moderately-high" toxicity and therefore consideration of exposure was not appropriate.
After consideration of the extensive arguments on both sides of this issue, the Court concludes that the Agency did not act arbitrarily and capriciously in declining to consider exposure in the listing decisions for this rulemaking. For the past eight years, in "31 of 32 listing/delisting determinations," 59 Fed. Reg. 61,442, the Agency has considered exposure only in limited circumstances, and it has followed that policy in the present rulemaking.
While a more clearly and fully articulated policy would be preferable, the Court cannot conclude that EPA was unreasonable in exercising its discretion by continuing to exclude consideration of exposure when chemicals are of high to moderately-high toxicity.
Plaintiffs' examples of listing and delisting decisions where EPA considered exposure do not prove that EPA unreasonably exercised its discretion by departing from past policy. Rather, those decisions reflect EPA's policy in practice, namely, that it will consider exposure when the subject chemical is of low toxicity. The fact that it is EPA's policy to consider exposure in some instances and not in others does not make the policy arbitrary, so long as there is a reasonable rationale for the policy and therefore for the Agency's exercise of its discretion.
Plaintiffs here have failed to show that EPA was unreasonable or arbitrary in exercising its discretion. Because EPA's decision to not consider exposure in this rulemaking was consistent with its policy of using exposure data only in particular circumstances, i.e., where chemicals are of low toxicity, the Court concludes that the Agency was not arbitrary and capricious.
B. Post-Hoc Rationalization
Plaintiffs' second major complaint about the final rulemaking is that EPA has engaged in post-hoc rationalization to defend its listing decisions. In essence, Plaintiff argues that EPA's lawyers have provided the explanations that EPA's staff and scientists should have provided.
Certainly, the voluminous briefs submitted by EPA, in response to Plaintiffs' equally voluminous challenges, are far longer and more detailed than some of the explanations for listing decisions on individual chemicals contained in the administrative record. But when an agency provides further explanation of its decision in the course of litigation, it is not necessarily engaging in post hoc rationalization. The rule is that an agency must defend its actions on the basis on which they were originally taken, not on some new basis that is developed in litigation to justify the decision. Motor Vehicle Mfr. Ass'n v. State Farm Mutual Auto Ins. Co., 463 U.S. 29, 50, 77 L. Ed. 2d 443, 103 S. Ct. 2856 (1983).
The rule against post-hoc rationalizations does not prevent a court from considering a more detailed explanation of an agency's action in response to a legal challenge. As long as the agency does not present a new basis for its action, it may supply a clearer or more detailed explanation. Methodist Hosp. of Sacramento v. Shalala, 38 F.3d 1223, 1233 n.11 (D.C. Cir. 1994) (court rejected plaintiffs' argument that position taken by agency in litigation was a post hoc rationalization, even though agency "could have placed a finer point" on the issue in its explanation in the record); International Ladies' Garment Workers' Union v. Donovan, 232 U.S. App. D.C. 309, 722 F.2d 795, 814 (D.C. Cir. 1983) (a court will "uphold a decision of less than ideal clarity if the agency's ...