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IN THE UNITED STATES DISTRICT COURT
PLAINTIFFS’ REPLY TO DEFENDANTS’ OPPOSITION TO INTRODUCTION Plaintiffs hereby reply to Defendants’ March 23, 2001 Memorandum in Opposition to Plaintiffs’ Motion for Preliminary Injunction ("Def. P.I. Opp.). Defendants’ understandable frustration and impatience to publish as final a document which EPA has taken over a decade to complete is no reason to permit the agency to publicly disparage Plaintiffs’ products based on improperly adopted and implemented cancer risk assessment policies. The agency has waited this long to publish its dioxin report, and there is no reason that it cannot wait the relatively short additional time necessary for the Court to determine whether the draft cancer guidelines were properly adopted. Because Plaintiffs satisfy the four-part test for preliminary injunction, the Court should therefore issue the relief Plaintiffs seek in order to prevent publication of the dioxin reassessment as final while this case is pending. Plaintiffs have demonstrated a strong likelihood of success on the merits. First, the dioxin reassessment is final agency action that represents the consummation of a lengthy agency process and from which legal consequences will follow for Plaintiffs and the public. The mere fact that the document has not been issued as final -- precisely the action that Plaintiffs seek to prevent -- does strip the Court of power to decide whether its issuance is proper. The cases Defendants cite in support of their assertion that EPA cannot be held liable for publication of a false and economically damaging report are inapposite. Second, the Administrative Procedure Act violations here are clear. Defendants concede that EPA never undertook the steps under APA section 553 necessary to issue either the 1996 or 1999 draft cancer guidelines as final replacements for the 1986 guidelines. The agency likewise has failed to provide any reasoned explanation for its change in position away from the 1986 final cancer guidelines, and there is clear evidence that EPA is applying multiple and inconsistent sets of guidelines in an arbitrary and capricious manner. Third, Defendants’ arguments against judicial enforcement of the Congressional Review Act are unpersuasive. Fourth, Plaintiff Brevet unquestionably has standing to challenge a damning government report blaming its products for increased environmental levels of (a) a "human carcinogen", that is (b) ten times more likely to cause cancer than previously believed. Plaintiffs also have provided ample evidence of the irreparable harm Brevet is likely to suffer from release of the dioxin reassessment in final form. The balance of the harms also strongly favors Plaintiffs, who unfairly suffer the stigma of association with a "human carcinogen" once the report is released. Finally, the public interest would be ill served by permitting the agency to publish highly questionable findings on dioxin carcinogenicity based on scientific methodologies so unproven that EPA is unwilling to subject them to the required adoption procedures. I. PLAINTIFFS ARE LIKELY TO SUCCEED ON THE MERITS A. The Dioxin Reassessment is Final Agency Action. Defendants open their discussion of final agency action with a footnote alerting the Court to the current status of the dioxin reassessment. Def. P.I. Opp. at 8-9 & n. 1. The fact that the reassessment is in draft form at this moment, however, does not prevent the Court from granting injunctive relief to prohibit issuance of the report as final, and Defendants’ ripeness argument fails. The two-pronged test for ripeness established by the Supreme Court in Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), requires the Court to consider both the "fitness" of the issues for judicial decision and the "hardship" to the parties of withholding review. Id. at 148-49; see also Chamber of Commerce of U.S. v. Reich, 57 F.3d 1099 (D.C. Cir. 1995) (holding executive order authorizing Secretary of Labor to disqualify certain employers from government contracts was ripe for review, notwithstanding argument that claims of injury might prove theoretical in the context of a particular case). Here, the both ripeness tests are met easily. Legal questions that require little factual development are more likely to be ripe. Thomas v. Union Carbide Agric. Prods. Co., 473 U.S. 568, 581 (1985); State of Montana v. Johnson, 738 F.2d 1074, 1076-77 (9th Cir. 1984). Although there are limited issues of fact concerning the regulatory effects of the dioxin reassessment, the legal issues in this case predominate, and the reassessment is thus "fit" for review prior to publication as final. Similarly, the "hardship" Plaintiffs seek to avoid is directly linked to the publication itself. It is the nature of injunctive relief that courts will seek to prevent to harm before it happens rather than wait for the harm to happen, and then try to make the plaintiff whole. Where necessary, courts have enjoined agency action on this basis prior to the occurrence of the challenged action. E.g., Independent Bankers Ass’n of Am. v. Smith, 534 F.2d 921 (D.C. Cir. 1976) (affirming injunction against Comptroller of the Currency’s ruling that customer-bank communications terminal was "bank" within meaning of relevant statute); see also Northern Alaska Envtl. Center v. Hodel, 803 F.2d 466, 471 (9th Cir. 1986) (affirming issuance of preliminary injunction preventing National Park Service from approving mining permits in national parks until agency had complied with National Environmental Policy Act); National Center for Immigrants Rights, Inc. v. INS, 743 F.2d 1365, 1368 (9th Cir. 1984) (upholding injunction against application of new INS regulation where regulation’s no-work provision would cause aliens awaiting deportation hearings irreparable harm). Defendants’ assertion that the Court lacks jurisdiction because EPA is still in the process of revising the dioxin reassessment should therefore be disregarded.
As Plaintiffs have previously described, the dioxin reassessment will have direct consequences in a number of EPA programs, including sludge, water quality, Superfund, and other areas. See P.I. Appl. at 12-13 & Exhs. C, D, E. The effects of the dioxin reassessment will be applied to programs nationwide, and the report thus will impact hundreds of individual regulatory outcomes across the country. In Appalachian Power Co. v. EPA 208 F.3d 1015 (D.C. Cir. 2000), the court noted that EPA’s state permitting guidance was national in scope and was reviewable even where petitioners had identified "no specific federal standard potentially subject to revision." Id. at 1024 & n.18. The same principle should apply here with respect to review of the dioxin reassessment. Defendants baldly assert, "The dioxin reassessment is not a rule". Def. P.I. Opp. at 19. This is plainly untrue, as evidenced by Defendants’ own admissions. The APA defines a "rule" as "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy...." 5 U.S.C. § 551(4). Defendants admit that a number of agency initiatives have been deferred pending the outcome of the dioxin reassessment. Def. P.I. Opp. at 34.1 For Defendants to assert simultaneously that the report will not act as an important instrument of policymaking, -- i.e., a "statement...designed to...prescribe...policy" -- is disingenuous at best. If the dioxin reassessment will have no impact on the "initiatives" to which Defendants allude, why have these initiatives been deferred pending completion of the report? The dioxin reassessment is therefore most certainly a "rule". Defendants cite two decisions from other circuits in an attempt to downplay the practical effects of the dioxin reassessment. Def. P.I. Opp. at 11-12. Significantly, both of these cases, NRDC v. EPA, 16 F.3d 1395 (4th Cir. 1993), and American Paper Inst. v. EPA, (7th Cir. 1989), pre-date the D.C. Circuit’s pragmatic holding regarding finality of agency "guidance" documents in Appalachian Power. The appellate courts in NRDC v. EPA and American Paper applied a more rigid test for finality in finding that modification of state or federal permits was a sine quo non of final agency action. See, e.g., NRDC v. EPA, 16 F.3d at 1407 (noting that water quality criteria "become regulatory only when a state adopts them"); American Paper, 882 F.2d at 289 ("If [EPA policy] ever leads to the denial or modification of a permit, the paper mill will be entitled to judicial review. Now is too soon."). Following Appalachian Power, such a requirement clearly does not apply in this circuit.2
Defendants next briefly argue that the dioxin reassessment, when published as final will not truly be final because the report "will not end EPA’s evaluation of the risks that dioxin exposes to human health." Def. P.I. Opp. at 13. This position smacks of the discredited government argument in Appalachian Power where the court criticized the agency’s description of an EPA guidance as non-final merely because it was subject to revision:
Appalachian Power, 208 F.3d at 1022 (citation omitted). The court went on to hold that the EPA guidance at issue was final agency action even though, like here, the agency was "currently developing even more detail in far more extensive ‘guidance’". 208 F.3d at 1024. Defendants emphasis on the continued evaluation of dioxin that the agency plans to undertake is therefore misplaced. Once released as final, the dioxin reassessment itself will qualify as the "consummation" of one of the longest and most involved initiatives in the agency’s 30-year history.
The parties do not dispute that the dioxin reassessment will be the subject of enormous publicity once the agency releases it as final. EPA correspondence with Congress that Defendants attached to their brief confirms the "very high visibility" and importance of the dioxin reassessment. In a January 11, 2001, letter from Defendant Noonan to Sen. Baucus, the agency stated:
Def. P.I. Opp. Exh. N at 2. Defendants’ only argument is that, under applicable case precedent, the agency cannot be held accountable for damage to Plaintiffs resulting from this publicity. Defendants cite two Supreme Court cases in renewed support for their blanket assertion that federal agency reports that cause informational harm to private parties are not subject to review under the APA. Def. P.I. Opp. at 13-14. Neither of these cases is on point. In the first case, Franklin v. Massachusetts, 505 U.S. 788 (1992), the Secretary of Commerce had allocated overseas military personnel to the state designated in their personnel records as their "home of record" for purposes of state congressional representative apportionment. The Court rejected plaintiffs the challenge to the Secretary’s allocation decision, holding that, because the President was not required to transmit the agency’s report directly to Congress under 2 U.S.C. § 2a(a), the Secretary’s decision was not final agency action. The Court stated, "[t]he core question is whether the agency has completed its decisionmaking process, and whether the result of that process is one that will directly affect the parties." Id. at 797 (emphasis added). The Court noted that the "Secretary’s report to the President carries no direct consequences for the reapportionment" and that it is "the President, not the Secretary, [who] takes the final action that affects the states." 505 U.S. at 798-99. Thus, unlike the dioxin reassessment, the report in Franklin had no independent impact because the President had the power and the duty to either accept or reject the Secretary’s proposed allocation of military personnel. Plaintiffs and the public in this case will have no similar choice to accept or reject the "finality" of EPA’s determinations regarding dioxin carcinogenicity. Likewise, in Dalton v. Specter, 511 U.S. 462, 470 (1994), the Supreme Court held that a recommendation by the Secretary of Defense and an independent Commission to close a military base was not "final agency action" under the APA because the reports "carr[ied] no direct consequences" and served "more like a recommendation than a final and binding determination." 511 U.S. at 469. Any decision to close the base ultimately would be taken by the President.3 Id. In this case, of course, no action of the President is needed for the dioxin reassessment to be released as final. Neither the President nor anyone else will need to review and approve the dioxin reassessment following its publication, and, once released, the reassessment will be EPA’s final word on the carcinogenic risks of dioxin. Like Franklin, Specter is therefore inapposite. See also Nation v. Dalton, 107 F. Supp.2d 37, 43 & n.5 (D.D.C. 2000) (distinguishing Specter from case challenging Secretary’s removal of officers from promotion list). Defendants’ fail in their attempt (Def. P.I. Opp. at 14-15) to minimize the three directly relevant cases Plaintiffs have cited, all of which hold that an agency report characterizing a substance as carcinogenic is judicially reviewable agency action. Defendants do not even discuss Synthetic Organic Chem. Mfrs. Ass’n v. Secretary, DHHS, 720 F. Supp. 1244, 1249 (W.D. La. 1989) ("SOCMA"), or Dow Chem. v. CPSC, 459 F. Supp. 378 (W.D. La. 1978), and their interpretation of Flue-Cured Tobacco Co-op. Stabilization Corp. v. EPA, 857 F. Supp. 1137 (M.D.N.C. 1994), is strained, at best. While the opinion in Flue-Cured Tobacco does note that EPA could not promulgate regulations under the Radon Act, that aspect of the case was only incidental to the court’s central holding that the report was reviewable because it was "definitive" and would have "direct practical effects on Plaintiffs." 857 F. Supp. at 1143-44. To conclude that the EPA dioxin reassessment, when released in final form, would not be "definitive" or have "direct practical effects on Plaintiffs" is to ignore the obvious. Plaintiffs have directed the Court to the most persuasive authority on point. The fact that Defendants’ reliance to Franklin and Specter is wholly misplaced is further borne out by subsequent case law. Since their publication nine and seven years ago, respectively, no federal court has cited either decision in a published opinion that also mentions either SOCMA, Dow, or Flue-Cured Tobacco (or even Industrial Safety Equip. Ass'n, Inc. v. EPA, 837 F. 2d 1115 (D.C. Cir. 1988)).4 The cases Defendants cite in opposition to the injunction are therefore unpersuasive and should be given little weight.
Contrary to Defendants’ allegations, Plaintiffs are not trying to prevent EPA from using the best science available for the dioxin reassessment. On the contrary, Plaintiffs encourage Defendants to do precisely that. Plaintiffs are concerned, however, that if the policies EPA is seeking to employ for the dioxin reassessment cannot withstand the rigor of congressionally mandated procedure, then perhaps those methodologies are not, in fact, the "best and most up-to-date scientific knowledge available." Def. P.I. Opp. at 18. As Plaintiffs have demonstrated, EPA has in fact violated the APA in adopting and relying on draft and proposed cancer guidelines as a basis for the dioxin reassessment. 1. APA Section 553 Violation Defendants concede, as they must, that EPA never undertook the steps necessary under APA section 553 to issue either the 1996 or 1999 draft cancer guidelines as final replacements for the 1986 guidelines. Therefore, if the Court concludes that the agency’s new cancer guidelines are modifications to binding substantive rules, the inquiry is at an end. The Court should declare the 1996 and 1999 cancer guidelines a violation of the APA, and the agency should be ordered to rescind the 1999 Final Report on pyrethins and refrain from publishing the dioxin risk assessments as final. As the D.C. Circuit observed in Appalachian Power, "It is well established that an agency may not escape the notice and comment requirements . . . by labeling a major substantive legal addition to a rule a mere interpretation." 208 F.3d at 1024 (citations omitted). Given that the D.C. Circuit has declared EPA’s 1986 cancer guidelines are "rules", International Fabricare Inst. v. EPA, 972 F.2d 384, 397 (D.C. Cir. 1992), and in light of the further holding in Chlorine Chem. Council v. EPA, 206 F.3d 1286, 1290 (D.C. Cir. 2000), that the so-called cancer "guidelines" are, in fact, binding on agency officials, EPA’s failure to follow appropriate APA procedure in amending the rules must render the new "guidelines" invalid.5 2. No Reasoned Explanation for Change in Policy Defendants agree that under APA precedent, an agency must "supply a reasoned analysis for its change in policy." Def. P.I. Opp. at 20 (citing Troy Corp. v. EPA, 120 F.3d 277 (D.C. Cir. 1997). Contrary to Defendants’ subsequent assertions, however, EPA never provided such an explanation. The 1986 final guidelines imposed the following strict limitation on agents included in the highest ("Group A -- Human Carcinogen") hazard classification:
51 Fed. Reg. at 34000; Compl. Exh. 1 at 2. There was and is good reason for this limitation. Before a substance truly is known to be carcinogenic to humans, scientists demanded evidence showing that, in fact, humans had been exposed to the agent and that the agent had caused cancer in the person exposed. While other forms of evidence, including studies of laboratory animals and studies of animal and human cells in petri dishes, were deemed suggestive of carcinogenicity to varying degrees, these studies did not provide the scientific certainty necessary to identify the agent as a known human carcinogen. The agency had decided, in short, that "known means known."6 None of the material Defendants cite at pp. 20-21 of their brief provides a reasoned explanation for the agency’s retreat from this position. Certainly the 1996 Federal Register notice does not supply one. Nothing in the 1996 notice even addresses the key issue specifically, i.e., the appropriate criteria for placement of substances in the highest hazard classification. The closest the notice comes to an explanation in this regard is the following statement:
61 Fed. Reg. at 17961. The above statement is tantamount in its explanatory value to the declaration, "We know more now than we knew then, and what we decide will depend on what we find out." This is not the reasoned explanation that the APA requires. Why, for instance, are the "modes of action" revealed in animal studies, which previously were considered inadequate to prove a substance is known to be carcinogenic in humans, now capable of demonstrating a causal relationship in humans with certainty? What "sophistication of research methods" make this certainty possible? What conditions, if any, will be placed on inferences that may be drawn from non-epidemiologic data? Stripped of its puffery, the agency’s 1996 "explanation" for its change in position is really no explanation at all. Similarly, the introductory pages of the 1999 draft guidelines (Def. P.I. Opp. Exh. A at v-xx) also fail to provide the reasoned explanation required for EPA’s abandonment of the "known means known" principle. Like the 1996 statement, the draft 1999 document does not specifically address this important policy change. Moreover, as Defendants’ note, the 1999 document is merely a "draft revision" of the 1996 discussion. The 1999 statements have never been published in the Federal Register, let alone published in the Federal Register as final. The cover of Defendants’ Exhibit 1 plainly states that the draft "should not be construed to represent Agency policy." It is ironic that Defendants cite, as the location of EPA’s "explanation" for its change in position, a document whose every page bears the words "DRAFT -- DO NOT CITE OR QUOTE". The draft 1999 document does not even approximate the type of published rationale required under the APA. Plaintiffs are not alone in reaching this conclusion. As noted in Plaintiffs’ previous brief, even the agency’s own Science Advisory Board faults the agency for not providing a clear rationale for the change from the 1986 guidelines:
SAB Executive Committee Review Draft, March 12, 2001 (Exh. 1 hereto) at 49 (emphasis added.) Thus, the agency has failed to provide any reasoned explanation for this crucial change in cancer hazard classification policy.
Finally, Defendants’ opposition brief completely fails to address Plaintiffs’ argument that the agency is applying multiple and inconsistent sets of guidelines to similarly situated parties in an arbitrary and capricious manner. See Compl. Exh. 1; P.I. Appl. at 22-23; Opp. to Mot to Dismiss at 23-27. As Plaintiffs have demonstrated, even the reviewers who worked on the dioxin reassessment do not know which set of cancer guidelines they are supposed to be applying, or why. There can hardly be stronger evidence of arbitrary and capricious agency action.
Defendants’ opposition brief does not deny Plaintiffs’ claim that the Congressional Review Act, 5 U.S.C. § 801, et seq. ("CRA"), applied to EPA’s issuance of the 1996 and 1999 cancer guidelines. Nor do Defendants dispute that EPA violated the CRA by failing to submit the 1996 and 1999 cancer guidelines to Congress and the Comptroller General as required under the act. Defendants’ sole response to Plaintiffs’ CRA claim is to argue that the entire statute is beyond the review of this Court. However, the legislative history of the CRA demonstrates clearly that Congress did not intend to preclude judicial review over all aspects of the act, including determinations of whether a rule has taken effect under section 801. See P.I. App. at 26-27. Defendants argue that the Court should ignore the legislative history Plaintiffs cite because the statute is "unambiguous". As Plaintiffs explained in their motion for injunction, however, the judicial review bar in section 805 must be read in the context of the whole statute, and it cannot be read to render meaningless the threshold provision of section 801(a)(1)(A) ("Before a rule can take effect..."). The conflict between section 801 and section 805 thus creates precisely the kind of ambiguity that makes reference to legislative history appropriate. See P.I. App. at 26 (citing Florida Power & Light Co. v. Lorion, 470 U.S. 729, 737 (1985) ("Because we find the statute ambiguous on its face, we seek guidance in the statutory structure [and] relevant legislative history...")). Defendants next challenge the legislative history Plaintiffs have cited, characterizing it as "particularly weak." The legislative record Plaintiffs have supplied is the most complete and accurate account of the statute available. The statements therein are not those of any "congressmen" as Defendants imply, but detailed explanations by the authors of the legislation at issue, explanations evincing a clear intent to limit judicial review, but not to exclude judicial enforcement entirely. While Defendants criticize courts’ reliance on congressional statements issued after passage of legislation, they offer no controlling authority on this point, nor do they cite any cases regarding the CRA. Moreover, other cases have held that it is appropriate for courts to rely on the type of statements Plaintiffs cite in order to clarify the intent of Congress. See, e.g., Pacific Gas & Elec. Co. v. State Energy Resources Conservation & Dev. Comm’n, 461 U.S. 190, 211 n.23 (1983) (giving weight to "expressions" of senator in subsequent Congress, where senator had been "an important figure in the drafting" of earlier legislation); North Haven Bd. of Educ. v. Bell, 456 U.S. 512, 535 (1982) (noting with respect to "postenactment developments" that Court "would be remiss if we ignored these authoritative expressions concerning the scope and purpose" of statute). Even Justice Scalia’s clever "oxymoron" criticism in United States v. Carlton, 512 U.S. 26, 39 (1994), which Defendants cite at p. 23 of their brief, was penned in a concurring opinion where the majority had, in fact, relied on such postenactment statements in reaching its holding. Defendants therefore have done little to rebut the clear legislative history supporting reviewability of Defendant’s violation of the Congressional Review Act, and they have offered no defense whatsoever in response to Plaintiffs’ substantive CRA claims. There is thus a very strong likelihood that Plaintiffs will prevail to this claim as well.
If Plaintiff Brevet, a manufacturer of PVC medical devices, does not have standing to challenge the dioxin reassessment, then arguably no one does. Brevet is clearly in harm’s way, as evidenced by the reasonable concern over lost sales, damage to business reputation, and other harms discussed in Plaintiffs’ motion for injunction. In support of their argument that Brevet lacks standing, Defendants place great emphasis on a single sentence from the five-page affidavit of Charles Brewer, Brevet’s president, in which Mr. Brewer states that he is unaware of any "presently available suitable substitute material for PVC tubing that offers the physical properties necessary to perform the critical functions of the devices used with the connectors Brevet produces." Brewer Affid. ¶ 5. The fact that Mr. Brewer is unaware of any "presently available" substitutes for products that other companies8 in the medical equipment industry supply, however, does not mean that Brevet is immune from harm caused by Defendants’ publication of the dioxin reassessment as final. Defendants simply have latched onto one minor statement, taken out of context, in an attempt to cobble together a viable argument against Brevet’s standing. As with any other product for which there are currently no suitable substitutes, the development of substitutes for PVC tubing is simply a function of money and time. If the foes of PVC succeed in eliminating PVC medical tubing, other -- more expensive -- products will follow.9 Brevet may or may not be technologically positioned to capture that new market. Even if Brevet is able to adapt to this change, however, that adaptation will come at a significant price. Defendants’ attempt to elevate one sentence from Mr. Brewer’s affidavit into a complete argument on standing while ignoring other clear statements regarding the threatened loss of his customers should therefore be given little weight. Just months ago Judge Emmet Sullivan of this Court concluded that Plaintiff Brevet had standing to challenge a similar government report on the carcinogenic hazard of dioxin. Defendants point to no evidence in support of their standing argument that was not presented to Judge Sullivan. Mr. Brewer made the identical statement regarding a lack of substitutes for PVC in his affidavit submitted in the earlier case. See Def. P.I. Opp. Exh. J at ¶ 5. Judge Sullivan nevertheless cited the Brewer affidavit the basis for his holding that Brevet had standing. See Tozzi v. DHHS, Civ. No. 99-1170 (D.D.C. Sept. 30, 2000) Mem. Op. at 8 ("Thus Brevet has demonstrated sufficient redressability and has standing to proceed in this case.") (attached as Exhibit 1). Defendants make much of Mr. Brewer’s allegations in Tozzi v. DHHS that publication of the 9th Report on Carcinogens, as it was then proposed, would cause Brevet "the exact same harm he seeks to avert in this case." Def. PI Opp. at 32. The mere fact that the harm Brevet feared from publication of the 9th RoC fortunately has not yet come to pass is no basis to conclude that such harm will not follow from issuance of the EPA dioxin reassessment as final. Indeed, the threat posed by the EPA report is all the more likely, in light of the publication of the contested 9th Report on Carcinogens during the appeal of Tozzi v. DHHS. At bottom, Brevet’s standing to challenge publication of a federal agency report stating that dioxin is a known human carcinogen was adjudicated in Brevet’s favor just six months ago. Judge Sullivan’s ruling of September 30, 2000, is now on appeal to the D.C. Circuit, where briefing is underway and where argument has been scheduled for September 17, 2001. Although Defendants may disagree with the finding of Judge Sullivan, it would not be in the interests of judicial economy for the Court to preempt the Court of Appeals on the question of Brevet’s standing.
As Plaintiffs indicated in their motion for injunction, Brevet stands to suffer tremendous harm as the result of activist and other public reaction linking its products to a "known" carcinogen. Although Defendants assert that this information has already been made available to the public, no such announcement has been made by EPA, the nation’s foremost authority on environmental health. The dioxin reassessment is being closely watched, and vocal opponents of Brevet’s products are poised to cite the report, if published as final in its current form, as vindication of their claims that all PVC products should be eliminated. Brevet has already felt some effects of this anti-PVC campaign and will surely suffer economic loss following the release of the reassessment. Once such losses are incurred, Brevet will be unable to recover damages against the government for harms this company should never have suffered. As between Brevet and Defendants, there can be little question that Brevet is in a far more vulnerable position. EPA, which has taken a full decade to complete the dioxin reassessment, will be scarcely be harmed by the modest delay review by this Court will require. Brevet, by comparison, may suffer loss of an enormous customer base that it could never hope to recover. The public also will be served by delaying release of the dioxin reassessment. If, as Defendants maintain, the hazards of dioxin are already widely publicized, then there is no urgency in releasing the EPA report. On the other hand, if there are flaws in the reassessment -- and there are many -- then neither the public interest nor the interest agency itself is advanced by premature release.
Finally, Defendants assert that the injunction Plaintiffs seek is overly broad because it would enjoin issuance of the entire dioxin reassessment, not just those portions "tainted" by Defendants’ use of the draft cancer guidelines. Def. P.I. Opp. at 35. Defendants misconstrue Plaintiffs’ claims as pertaining solely to the reassessment’s characterization of dioxin as a "human carcinogen". Plaintiffs have never limited their concerns merely to hazard characterization, and other aspects of the dioxin reassessment also represent the product of EPA’s use of the draft cancer guidelines. However, if Defendants are able to distinguish and certify those portions of the reassessment that are based solely on the 1986 final cancer guidelines, then Plaintiffs would have no objection to the agency’s publication of that portion of the dioxin reassessment. CONCLUSION For the foregoing reasons, Plaintiffs’ application for a preliminary injunction should be granted.
ENDNOTES: 1. In their original brief filed March 23, 2001, Defendants stated, "Many potential regulatory initiatives have been deferred pending the outcome of this effort". Def. P.I. Opp. at 34. In their "corrected" brief filed April 3, 2001, Defendants downgraded the number of deferred initiatives to "some" and dropped the inadvertent, but incriminating, word "regulatory". These nice semantic distinctions aside, based on previous agency statements (e.g., P.I. Appl. Exh. E at 9), Plaintiffs anticipate that discovery will confirm the true regulatory impact of the dioxin reassessment. 2. Remarkably, Defendants do not even cite Appalachian Power in their opposition to Plaintiffs’ motion for preliminary injunction, let alone attempt to address the many important implications of that decision to this case. 3. In both Specter and Franklin, the Court also ruled that the APA did not afford the relief sought because the challegned action was that of the President, who is not an "agency" under the APA. Specter, 511 U.S. at 469-70; Franklin, 505 U.S. at 800-01. 4. Defendants also cite Industrial Safety Equip. Ass’n v. EPA, 837 F.2d 1115 (D.C. Cir. 1988), in this section of their brief. Plaintiffs have previously addressed the Industrial Safety decision (see Pl. Opp. to Mot. to Dismiss at 12-14) and respectfully refer the Court to that discussion. At bottom, the Industrial Safety case should be remembered for the D.C. Circuit’s affirmation that the reviewability of agency reports must be judged on a "case-by-case basis." Id. at 1117. 5. Defendants discuss Chlorine Chem. at some length in defense of their right to use the "best available science" for risk assessments. Def. P.I. Opp. at 19-20. As noted above, Plaintiffs have no quarrel with this laudable policy, which, in fact, was statutorily mandated in Chlorine Chem. 206 F.3d at 1290. For purposes of the present case, however, the importance of Chlorine Chem. is not the directive under the Safe Drinking Water Act, but the court’s holding that the agency is not free to deviate from its own cancer guidelines. 6. Plaintiffs offer this layman’s explanation for the rationale behind the 1986 guidelines as background only and in no way imply that the Court should "substitute its judgment for that of the agency" on the best approach to hazard characterization. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971). Such scientific expertise is unnecessary, however, for the Court to fulfill its proper role of determining whether EPA has supplied a reasoned explanation for the agency’s change in policy. See Troy Corp. v. Browner, 120 F.3d 277, 291 (D.C. Cir. 1997) ("Absent further explanation of its different approaches in the two cases, the agency has acted arbitrarily and capriciously...."). 7. At other points in the SAB subcommittee report, the reviewers refer to their application of the 1996 guidelines, rather than the 1999 guidelines. See, e.g., Opp. to Mot. to Dismiss Exh. 1 at 13 (Question 11 of charge to subcommittee, citing 1996 guidelines). 8. The vast majority of Brevet’s sales are of "plastic connectors for use with PVC tubing" that other companies supply. See Brewer Affid. at ¶¶ 4, 10 (emphasis added.). 9. The EUCOMED document Defendants attached to their opposition makes this basic economic point when it explains that PVC medical products were originally developed as "cost-effective" replacements for other materials. See Def. P.I. Opp. Exh. D at 3.
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