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IN THE UNITED STATES DISTRICT COURT ______________________________________ Civil Action No. 99-1170 ______________________________________ JIM J. TOZZI, et al., Plaintiffs, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants. _______________________________________ REPLY TO DEFENDANTS' OPPOSITION TO Charles J. Fromm Attorneys for Plaintiffs Dated: January 31, 2000 TABLE OF CONTENTS
TABLE OF AUTHORITIES
Preliminary Statement Plaintiffs hereby respond to Defendants' Opposition to Plaintiffs' Cross-Motion for Summary Judgment. As in previous briefings, Plaintiffs incorporate by reference their earlier briefing filed in connection with their application for preliminary injunction and their opposition to Defendants' motion to dismiss.1 I. Response Concerning Statement of Material Facts Not in Dispute In their opposition brief, Defendants' first quibble with certain statements set forth in Plaintiffs' Statement of Material Facts Not in Dispute. (Def. S.J. Opp. at 2). Defendants do not allege that Plaintiffs have misstated the record, however, and Plaintiffs agree that the record speaks for itself. Defendants' objections as to what Plaintiffs' statements of undisputed fact may "imply" are therefore misplaced, because such inferences are for the Court alone to draw. The only point that warrants a specific response is Defendants' assertion ¶ (3) that the April 1999 Federal Register "clarifications" did not constitute a change in the agency's position on the "known" criteria. In Defendants' words, "the 'clarification' simply restates the exact language of the revised criteria." (Def. S.J. Opp. at 2) (emphasis added). This statement is indisputably untrue. The April 19, 1999 Federal Register notice contains the following sentence concerning the final disputed paragraph of the revised criteria:
Nothing even approximating the above statement is contained in the revised listing criteria published in September 1996. To the contrary, as Plaintiffs have repeatedly demonstrated, the revised criteria make clear that the final paragraph does not apply to the known carcinogen listings. Defendants' claim that the agency did not change its position in 1999 by issuance of the above statement is therefore completely off the mark. II. Defendants' Objections to Plaintiffs' Standing Are Unpersuasive. With respect to the question of Plaintiffs' standing, Defendants first assert that Plaintiffs' summary judgment brief confuses constitutional standing requirements with prudential standing considerations and the zone of interest test. Defendants' "cryptic analysis" barb notwithstanding, however, (Def. S.J. Opp. at 4), Plaintiffs' brief demonstrates a clear familiarity with standing jurisprudence. After a full discussion of how Plaintiffs satisfy the three prerequisites for Article III standing (Pl. S.J. Mem. at 3-5), Plaintiffs do note in one paragraph of their brief that Plaintiffs had also satisfied the requirements for prudential standing under the zone of interest test. Id. at 5. As Plaintiffs' initial briefing demonstrated, Plaintiffs are (1) threatened with real and imminent injury that is (2) fairly traceable to the proposed dioxin listing, but which is (3) clearly redressable by an Order of this Court. Moreover, Plaintiffs fall within the zone of interest of the statute that authorizes and mandates publication of the RoC. Defendants next object to Plaintiffs' observation that if Brevet does not have standing, "then arguably no one does." (Def. S.J. Opp. at 4). While Defendants are correct that the standing inquiry does turn on the individual facts of each case, Defendants' subsequent discussion is mere reiteration of their earlier argument that RoC listing actions are never reviewable. In other words, according to Defendants, if no plaintiff has standing to challenge proposed listings in the RoC, then so be it. This position is clearly contrary to the intent of Congress and applicable case law. See Synthetic Organic Chem. Mfrs. Ass'n v. Secretary, DHHS, 720 F. Supp. 1244 (W.D. La. 1989) ("SOCMA"). Under the APA, there is a strong presumption in favor of judicial review of agency action. Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986). The strong presumption in favor of judicial review may be overcome only upon a showing of clear and convincing evidence of a contrary legislative intent. Traynor v. Turnage, 485 U.S. 535, 542 (1988) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 141 (1967)). Defendants have not even asserted, let alone demonstrated, any such contrary congressional intent here.2 Next, Defendants attempt to defeat Plaintiffs' standing by reference to the showing made in SOCMA, supra. In SOCMA, the court held not only that RoC listing decisions were reviewable agency action, 720 F. Supp. at 1250, but that the plaintiffs in that case had met the requirements for standing. Id. at 1248. But the SOCMA court never said that it was limiting standing only to plaintiffs that manufacture products proposed for listing in the RoC. Likewise, no other court has ruled that only chemical manufacturers have standing to challenge RoC listings. Standing was conferred in SOCMA based on expectations of reductions in plaintiffs' sales, id., which is exactly the case here. Defendants object that, unlike the SOCMA plaintiffs, Brevet has not produced a "consumer reaction study" showing that a "significant reduction in their products" (sic) would result. (Def. S.J. Mem at 5). While the SOCMA plaintiffs concededly chose to demonstrate potential harm through their own methodology, sufficient evidence of harm has also been presented in this case. As this Court has recognized, "even a minuscule pecuniary stake of the litigant" may be sufficient to satisfy the standing requirements where larger values (such as government's adherence to its own rules) are at issue. American Bankers Ins. Group v. Board of Governors of the Federal Reserve Sys., 3 F. Supp. 2d 37, 41 (D.D.C. 1998) (Sullivan, J.) (quoting National Automatic Laundry and Cleaning Council v. Schultz, 443 F.2d 689 (D.C. Cir. 1971)). Here, Plaintiffs have previously submitted compelling evidence of anticipated customer and other third party behavior, both for Brevet and for the restaurant Plaintiffs, that will lead to direct pecuniary injury. See, e.g., Pl. S.J. Mem. Exh. 1 (Affid. of Brevet's President with attached press release regarding decision of Brevet customers, and potential decision of other customers, to phase-out purchases of PVC-containing products); Pl. Opp. Exhs. 10, 13, 14, 15, 16, 18 (press reports demonstrating harm to restaurants from recent European dioxin food scare); Affids. of Wexler and Leonard (attached to Pl. Opp.) (attesting to likelihood and degree of harm restaurant Plaintiffs face). The evidence of threatened harm previously adduced in this case is therefore clearly sufficient to support standing. See Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., ___ U.S. ___, 2000 WL 16307 at * 11 (Jan. 12, 2000) ("reasonable concerns" about threatened harm sufficient to support standing). III. This Case Is Ripe for Adjudication. Defendants next resurrect their neglected ripeness argument in a belated half-response to Plaintiffs' earlier refutation. See Mot. Dismiss at 12-21; Pl. Opp. at 5-18; Def. Reply at 7-9; Pl. S.J. Mem. at 12-16. In that earlier briefing, Plaintiffs had undercut Defendants' citation to Pfizer, Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999), by noting that in Pfizer the court expressly cautioned that the case might have been ripe if the agency action had "somehow foreclosed Pfizer's right ever to get meaningful judicial review." 182 F.3d at 979. Such is exactly the case here, given the immediate and widespread publication of the proposed dioxin listing, the immunity of the government from a subsequent suit for money damages, and the practical absence of any other defendant from whom Plaintiffs might recover compensation. 3 Defendants nevertheless cite Pfizer again in their opposition brief and address the lack of meaningful post-publication opportunity for review. Def. S.J. Opp. at 6-7. The gist of Defendants' ensuing discussion, however, is mere repackaging of their "speculative harm" argument and says nothing about ripeness. According to Defendants, the case is not ripe because the harm to Plaintiffs "is not so immediate or likely". Id. at 7. Defendants cite no additional cases, and certainly none that might support the remarkable assertion that a court should disregard the lack of subsequent remedy as a factor in the ripeness analysis. It is both circular reasoning and too cavalier of Defendants to simply assume that "no irremediable adverse consequences [will] flow from requiring a later challenge." Toilet Goods Ass'n v. Gardner, 387 U.S. 158, 164 (1967), quoted in Pfizer, supra, 182 F.3d at 979. Defendants' renewed ripeness argument is therefore mere bluster and should be disregarded in its entirety. 4 IV. Defendants' Arguments on the Merits Are Unresponsive "Once more unto the breach." 5 In their latest brief, Defendants again adopt a strategy of urging the Court to "put on the Chevron 6 glasses" and simply overlook the agency's disregard of its own listing criteria. While the standard may be deferential to the agency, (Def. S.J. Opp. at 8), deference has limits, and the Court is obliged to make a "searching and careful" review of the agency action and record. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415, 416 (1971); Wawszkiewicz v. Department of Treasury, 670 F.2d 296, 301 & n. 42 (D.C. Cir. 1981); Ethyl Corp. v. EPA, 541 F.2d 1, 34-37 (D.C. Cir.) (en banc), cert. denied, 426 U.S. 941 (1976). Where the agency has failed to consider the "relevant factors" in reaching its decision, for example, or where the agency has departed from its settled course without a reasoned justification, a court must find the conduct arbitrary and capricious. See P.I. App. at 12-13 and cases cited therein. Plaintiffs are confident that, when the Court performs its "searching and careful" review, the fatal errors in Defendants' portrayal of the facts will be clear. A. Defendants' Reliance on Mechanistic and Animal Data to Upgrade Dioxin to a "Known" Human Carcinogen, in the Absence of "Sufficient" Epidemiological Data, Disregards Their Own Listing Criteria. The parties agree that epidemiological evidence alone cannot support the proposed dioxin listing. Unless Defendants can somehow broaden the term "studies in humans" to include mechanistic data, their case on the merits crumbles entirely. The merits section of Defendants' latest brief thus is once again replete with references to various points in the record indicating that mechanistic data will be considered "in determining carcinogenicity", or "in making RoC listings", or words to this effect. As Plaintiffs have previously explained, however (Pl. S.J. Opp. at 22), these statements do not support Defendants' assertion that mechanistic data are to be considered for both categories of listings. That mechanistic data were to be considered for RoC listings at all -- i.e., for reasonably anticipated listings -- was news following the 1995-96 revisions, and Defendants' statements taken out of context should not mislead the Court. Defendants begin by assuming their conclusion, i.e., by citing to the disputed final paragraph from the revised listing criteria. Plaintiffs have no qualms with Defendants' claims (Def. S.J. Opp. at 8) that the quoted language -- "based on scientific judgment with consideration given to all relevant information" -- leaves room for consideration of mechanistic data. As previously briefed, however, (e.g., P.I. Reply at 5-12), this paragraph does not apply to the known carcinogen listings. Defendants then note that the "question" of "whether mechanistic data could properly be considered" was a "central issue" prompting the 1995-96 criteria revisions. (Def. S.J. Opp. at 8-9). Finding evidence in the record that the "issue posed was clearly answered in the affirmative" (id. at 9), Defendants are satisfied that the debate is over. This transparent equivocation, playing on the words "be considered", should not fool the Court. The new feature of the criteria was that mechanistic data were be used at all, i.e., for the "reasonably anticipated" category. Next, Defendants stack several record references together in support of their claim that mechanistic data may augment insufficient human data to support known carcinogen listings. (Def. S.J. Opp. at 9). Unpacking Defendants' record citations, however, one finds slim evidence in this regard:
The statement by Dr. Barrett regarding use of mechanistic data to "upgrade" a listing is undeniably part of the record. This vague remark, however, which does not appear as a quotation in the summary minutes, was at most the opinion of one NTP staff member. 7 The same is true for Defendants' subsequent reference to the statement of Dr. Jameson with regard to the final explanatory paragraph. (Def. S.J. Opp. at 9-10). These statements represent the views of individual committee participants and were not adopted by any full committee -- and certainly not by the agency. The bottom line is that Defendants Shalala and Olden, the only HHS officials with responsibility for final decisions, approved revised RoC criteria in 1996 that do not allow consideration of mechanistic data to support known human carcinogen listings. The contemporaneous evidence in this regard is beyond dispute. See Am. Compl. Exhs. 2, 3, 4, 9; P.I. App. at 24; P.I. Reply at 13-14. Both sides in this case agree that mechanistic data were not used as a basis for any RoC listings prior to 1996. Both sides also agree that the revised criteria permitted consideration of such for at least some RoC listings following the 1996 revisions. Under Defendants' theory, mechanistic data were therefore available to support "known" carcinogen listings in the 8th RoC, which was published in May of 1998. Yet of the 70 substances that were listed as known human carcinogens in the 8th RoC, none was classified as a known human carcinogen based on mechanistic data where the epidemiological data were less than sufficient. Not one. See P.I. App. Exh. 1. Defendants' response is that the term "studies in humans" must include mechanistic data. But if "studies in humans" includes mechanistic data, why do the Draft Background Documents treat "Mechanism of Carcinogenesis" and "Human Studies" data as entirely distinct categories? Why is each is afforded its own separate section of the document, where wholly separate bodies of evidence are examined? Moreover, why does IARC -- whose technical nomenclature NTP has adopted in all key other respects -- ascribe absolutely distinct meanings to these two terms? The answer is because mechanistic data are not included among "studies in humans" anymore than are animal or in vitro data. B. Defendants' Refusal to Address Critical Omissions in the In the final section of their opposition brief, Defendants attempt to sweep under the rug the agency's complete failure to address key aspects of the scientific evidence during the dioxin review. Their strategy in this regard is twofold. First, Defendants misconstrue Plaintiffs' argument as demanding "an examination of each voter's mind" (Def. S.J. Opp. at 12), which is impossible. Second, Defendants once again attempt to intimidate the Court from undertaking what Defendants describe as a "review [of the] scientific evidence." (Def. S.J. Opp. at 14 & n. 4). Neither of these arguments should prevail. First, Plaintiffs obviously have not asked Defendants to demonstrate powers of telepathy, or even to provide the reason why each member of the various review committees voted as they did. Plaintiffs do demand proof, however, that the correct listing criteria, a fair description of the scientific evidence, and a true and accurate proposed listing rationale were supplied to the members of the review committees. In the absence of telepathy, we must assume that review committees who voted after the September 30, 1997 Draft Background Document ("DBD") was drafted did so on the basis of the rationale set forth in that document. Remarkably, Defendants have now attempted to distance themselves from the DBD and its listing rationale. See Def. Opp. at 13 n. 3 (stating that a vote in favor of the upgrade proposal was not a vote "for" or "against" the DBD). Defendants' apparent strategy in this regard is to confuse the Court into thinking that the proposed dioxin listing might, in fact, have been based on something other than the impermissible rationale provided in the DBD. In support of this notion, Defendants cite extensive portions of the 1997 meeting of the RoC Subcommittee as evidence of the reviewing scientists' scientific independence and "personal integrity" during the review process. 8 Dr. Lucier stated during that meeting that the DBD reflects "what we did in RG1 and RG2," and that to understand the basis for the proposed listing one "would simply have to read the green document", i.e., the DBD. Transcript of Oct. 31, 1997 RoC Subcommittee Meeting, attached hereto as Exhibit 1, at 53 9. Therefore, there can be no argument that the DBD reflects the Defendants' rationale for the proposed listing. Significantly, Dr. Lucier noted in his October 1997 remarks that the "sequence of events involved in carcinogenesis has not been worked out for dioxin," but that data relating to this process was part of "a combination of pieces of information that was used by RG1 and RG2 to reach their final vote." Thus, it is clear that (1) both RG1 and RG2 relied on mechanistic and animal data for their known human carcinogen listing, and (2) those committees' rationale -- as stated in the DBD -- forms the basis for the final agency listing decision at issue in this case. The Court need not read minds to reach this conclusion. A final point about Defendants' sudden retreat from the DBD. If, as Defendants apparently now maintain, there was some miscommunication or other reason for concern about the basis for the proposed dioxin listing, as stated in the DBD, then the agency had a full year to rewrite the document and correct any error. The DBD listing rationale was reproduced without a single edit, however, following the re-review ordered by Defendant Olden. Only a short bibliographic supplement was added. This confirms Defendants' clear intent to rely on the rationale stated in the DBD as the basis for the proposed listing. Second, Plaintiffs emphasize again that the Court need not play the role of supervising scientist. Plaintiffs have made two very straightforward claims regarding Defendants' failure to address errors in their presentation of the scientific record. To fulfill its obligation to make a "searching and careful" review of these claims, the Court need only read the record that has been cited. Defendants' opening summary judgment brief merely repeated, largely verbatim, arguments Defendants made in their opposition to Plaintiffs' application for preliminary injunction. Compare Def. P.I. Opp. at 29-32 with Def. S.J. Mem. at 23-26. Plaintiffs responded to these arguments fully in their P.I. Reply (at 16-19), and see nothing new in Defendants' latest brief. Accordingly, Plaintiffs stand on their previous submissions. 10 V. Defendants' Insufficient Response to Plaintiffs' Key Factual Questions Points Up the Appropriateness of Summary Judgment in Plaintiffs' Favor. Defendants correctly interpret Plaintiffs' list of key factual questions as a point blank challenge to Defendants to clarify and support their position by reference to the record. Defendants' evasive responses, however, demonstrate their inability to meet that challenge. Plaintiffs reply to each of Defendants' responses in turn below.
Apparently Defendants' answer is "yes." The answer necessarily reflects Defendants belief that either (1) mechanistic data can be used to turn less than "sufficient" human data into "sufficient" human data, or (2) the new criteria no longer require "sufficient" human data. Assuming Defendants intend the former, their answer completely fails to explain how this new position comports with the established, precise meaning of the words "sufficient" or "causal relationship". The response does not address how mechanistic data can be deemed "sufficient" in the technical sense, that is, distinct from "limited" human evidence. How does mechanistic data provide certainty beyond a finding that a "causal relationship is credible, but that alternative explanations, such as chance, bias or confounding, could not be adequately excluded"? Defendants do not provide a reason why the agency is departing from its previous and long standing position on the meaning of these words, or why the agency is now, after many years, abandoning its practice of giving these words the same precise meaning as IARC gives them. See P.I. App. at 19-20. Defendants instead merely restate their conclusion that mechanistic data are to be considered in making known carcinogen listings. Their conclusory statement that the proposed upgrade is based on sufficient evidence from studies in humans is contrary to the agency's rationale expressed in the DBD. Plaintiffs' question did not imply that references to animal data need be stricken from the DBD. Had the agency stated that there were "sufficient" data from studies in humans, the DBD's subsequent references to animal and mechanistic data would never have become controversial .Plaintiffs note, however, that Defendants have inadvertently put their finger on the problem with using mechanistic data to supplement human data. Defendants state: "the human mechanistic data becomes relevant when compared to the animal data". Thus, Defendants effectively admit to basing the proposed dioxin listing on comparisons to animal data. Without "comparison to" -- i.e., without use of -- the animal data, the so-called "human mechanistic data" are irrelevant. Defendants would have the Court believe that they are not relying on animal data, they are just using the animal data in the listing process. This is doublespeak.
Defendants' answer points to no such instance. Rather, their response attempts to backpedal from the Draft Background Document for the proposed dioxin listing, which clearly states that the listing is based on evidence from human studies that is "limited", i.e., not "sufficient", as the published listing criteria require. IARC also concluded that the epidemiological data are only "limited". P.I. App. at 22. Again restating their conclusion, Defendants apparently consider it simply unimportant that, for the first time ever, the agency is proposing to list a substance as a "known" human carcinogen in the absence of "sufficient" epidemiologic evidence, as required by the plain language of the listing criteria.
Defendants casually state that the "entire administrative record" is "proper notice" of the sweeping and dramatic departure from the agency's previous position on the use of mechanistic data. They identify no single exhibit or other portion of the record, however, where this change was plainly and unmistakably announced to the public and explained and justified. Plaintiffs similarly are aware of no point in the record where such a statement was issued, prior to the agency's response to Mr. Tozzi and his counsel in anticipation of this litigation.
Defendants' response that "these releases were referring to the precise wording of the known category only" is unintelligible, as is their claim that these formal agency statements do not "nullify" the final descriptive paragraph. The press releases state clearly that the "known category" remained "substantively unchanged" from the previous version, which did not allow consideration of mechanistic data. Defendants concede, at least, that the final paragraph was "expected to have the greatest impact" upon the reasonably anticipated category. The point remains that at the time the 1996 revisions were formally issued, the Secretary of HHS and the Director of NTP approved official agency publications stating that the criteria for known human carcinogen listings in the RoC would be "unchanged" from the previous version. These statements were consistent with the contents of the Federal Register notice approved at the same time. Defendants cannot hide from these undeniable and decisive facts.
The review processes Defendants reference preceded the criteria revisions, and are, at the very most, ambiguous. The review committee records never state that such a change is being made. Even if they did, which Plaintiffs vigorously dispute, it would be the province of the HHS Secretary and Defendant Olden to announce such a change.
Defendants avoid a response to this question, which obviously concerns the statements from the first page of the DBD regarding the Bertazzi study. The DBD states:
Am. Compl. Exh. 9 at RC-1 (emphasis added). Contrary to the above statement, the 1998 Bertazzi study did not present any new findings, and IARC did, in fact, consider the Bertazzi findings. To understand the error in the above DBD statement, the Court need only read what IARC actually considered (Pl. Appl. Exhs. 11 and 9), and compare this to the findings of the Bertazzi et al. articles published in 1997 (Pl. Appl. Exh. 12) and 1998 (P.I. Reply Exh. 6). See also P.I. Reply at 17-18. This limited inquiry does not require the Court to undertake an independent "analysis of the scientific evidence" as Defendants assert, or to delve into any matters beyond the Court's expertise.
Defendants evidently cannot. The reason they cannot is because IARC found that the epidemiologic evidence was only "limited", as Defendants concede. IARC's criteria, however, explicitly allow substances to be upgraded to the highest IARC category based on "limited" epidemiologic data if accompanied by strong mechanistic data. The HHS criteria for known human carcinogen listings in the RoC do not. The agency rationale, as stated in the DBD, is therefore erroneous in indicating that IARC made a finding of causal relationship.
Defendants' response affirms Plaintiffs' reading of the record. There is no reference in the record to a finding that evidence from studies in humans indicates a causal relationship between dioxin exposure and human cancer. Absent such a finding, the proposed listing is invalid.
Defendants do not, and cannot, cite any specific point in the record where the agency publicly announced the dramatic criteria revision prior to initiation of this litigation. No such statement was ever made.
Defendants are unable to provide any reference to the administrative record showing that the agency considered and reasonably responded to these issues. CONCLUSION Defendants' brief in opposition fails to raise either new factual questions or new legal arguments that would preclude summary judgment in Plaintiffs' favor. Accordingly, for the foregoing reasons and for the reasons set forth in previous briefing, Plaintiffs' Motion for Summary Judgment should be granted, and Defendants' Renewed Motion to Dismiss and/or for Summary Judgment should be denied. For all of the foregoing reasons, Plaintiffs’ application for injunction should be granted. Respectfully submitted, _______________________ January 31, 2000 1 Plaintiffs use the following abbreviations throughout this filing to refer to previous briefing: 2 Defendants' citation to this Court's decision in H&F Enters. Ltd. v. United States, 973 F. Supp. 170, 174 (D.D.C. 1996) sheds little light on their argument. In that disappointed bidder case, the Court ruled that the plaintiff contractor had standing to challenge the General Services Administrations' decision to select a building site from within a "centralized community business area", but not to challenge the defendant's final site selection. Id. at 175. The case involved a very dissimilar government action, did not concern any threatened loss of sales, is thus readily distinguishable on its facts. 3 As Plaintiffs have previously noted (Pl. Opp. at 5-6), the ripeness doctrine is to be applied pragmatically, with due regard to the circumstances surrounding each case. See, e.g., Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967); Flue-Cured Tobacco Co-op Stabilization Corp. v. United States EPA, 857 F. Supp. 1137, 1143 (M.D.N.C. 1994) (employing "a pragmatic approach, as well as a flexible view of finality"). 4 Defendants' eagerness to reinsert their ripeness challenge into the case is curious, given that Defendants' position has weakened from a factual standpoint. As Plaintiffs have previously advised the Court, the RoC was forwarded to Defendant Shalala for her approval shortly before the parties' filing on January 17, 2000. Defendants do not reference this fact in their brief. 5 William Shakespeare's Henry the Fifth, Act III, Scene 1. 6 Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). 7 Plaintiffs do not concede the accuracy of the 1995 criteria review committee minutes in this regard. 8 The October 1997 RoC Subcommittee meeting resulted in a 4-3 vote in favor of the proposed dioxin upgrade, a vote which was overturned when Defendant Olden subsequently ordered a re-review. See Am. Compl. Exh. 12. Even though the sub-committee reversed itself the following year, Defendants have ignored that committee's recommendation and have proceeded with the proposed upgrade (as evidenced by the NTP Executive Committee's vote). 9 These transcript pages were omitted from the administrative record Defendants filed with their cross-motion for summary judgment. See R. 16. Plaintiffs did not submit the transcript pages prior to today because Defendants had not previously attempted to disavow the stated rationale for the proposed dioxin listing, as set forth in the DBD. 10 Defendants' perfunctory defense of the agency's position on chemical mixtures (Def. S.J. Opp. at 14 n. 4) warrants little comment. The Court is again directed to the agency's baffling non-response to Mr. Tozzi's concerns in this regard. Am. Compl. Exhs. 15-17; see also P.I. Reply at 18-19. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||