Animal Legal Defense Fund v. Glickman, 154 F.3d 426, 442 (D.C. Cir. 1998)	14
* Block v. Meese, 793 F.2d 1303, 1309 (D.C.Cir.), cert. denied, 478 U.S. 1021 (1986)	13
Blum v. Yaretsky, 457 U.S. 991, 1001 (1982)	12
Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 221 (D.D.C. 1996)	18,19
Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., ___ U.S. ___, 2000 WL 16307 (Jan. 12, 2000)	11
Holland v. Frank V. Carlow Irrevocable Trust, 176 F.R.D. 416, 418 (D.D.C. 1997)	19
International Union of United Auto., Aerospace & Agric. Implement Workers of Am. v. Brock, 783 F.2d 237, 247 (D.C.Cir.1986)	13
Microwave Acquisition Corp. v. Federal Communications Comm’n, 145 F.3d 1410, 1412 (D.C. Cir. 1998)	15
Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co. 463 U.S. 29, 43 (1983)	26
* National Comm. to Preserve Social Security v. Bowen, 735 F. Supp. 1069, 1081 (D.D.C. 1990)	13
National Wildlife Federation v. Hodel, 839 F.2d 694, 705-06 (D.C.Cir.1988)	13
* Natural Resources Defense Council, Inc. v. Jamison, 787 F. Supp. 231, 237 (D.D.C. 1990)	9,12
Patriot v. United States Dept. of Housing and Urban Dev., 963 F. Supp. 1, 5 (D.D.C. 1997)	19
Public Citizen v. Lockheed Aircraft Corporation, 565 F.2d 708, 717 n. 31 (D.C.Cir.1977)	13
TEAC America, Inc. v. United States Dept. of Navy, 876 F. Supp. 289, 294 (D.D.C. 1995)	19
Telephone and Data Systems, Inc. v. FCC, 19 F.3d 42, 47 (D.C. Cir. 1994)	14
University Medical Center v. Shalala, 173 F.3d 438 (D.C. Cir. 1999)	9
Virginia Petroleum Jobbers Ass’n v. FPC, 259 F.2d 921, 925 (D.C. Cir. 1958)	18
Wilderness Soc’y v. Griles, 824 F.2d 4, 12 (D.C. Cir. 1987)	12
Wisconsin Gas Co. v. Federal Energy Regulatory Comm’n, 758 F.2d 669, 674 (D.C. Cir. 1985)	16,17,18
WMATC v. Holiday Tours, Inc., 559 F.2d 841, (D.C. Cir. 1977)	18
42 U.S.C. § 241(b)(4)	25-26
H.R. Rep. No. 95-1192, 95th Cong., 2d Sess., at 22 (1978)	16

Authorities upon which we chiefly rely are marked with asterisks.

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
CIVIL DIVISION

______________________________________

Civil Action No CV:99-1170 Judge Emmet G. Sullivan

______________________________________

JIM J. TOZZI, et al.,

Plaintiffs,

v.

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.,

Defendants

______________________________________

PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ RENEWED
MOTION TO DISMISS AND/OR FOR SUMMARY JUDGMENT

Plaintiffs, through their undersigned counsel, hereby oppose Defendants’ Renewed Motion to Dismiss and/or for Summary Judgment.

As in their Memorandum in Support of Motion for Summary Judgment ("Pl. S.J. Mem.)¹, Plaintiffs hereby incorporate the briefs they filed in connection with Defendants’ Motion to Dismiss and Plaintiffs’ Application for Preliminary Injunction and respectfully refer the Court to authorities and arguments in those earlier filings. Instead of repeating all the arguments previously made, Plaintiffs today stress only what is vital for the Court’s determination of this case, including consideration of a very recent Supreme Court opinion addressing injury in fact and standing. Plaintiffs also rebut the few new arguments and authorities that Defendants raised in their Renewed Motion to Dismiss and/or for Summary Judgment.

On December 17, 1999, counsel for Defendants mailed to Plaintiffs what Defendants described as "a true and accurate copy of the administrative record in this case." Notice of Filing Administrative Record (Dec. 17, 1999). Defendants expressly "reserve[d] the right to supplement this record as needed." Id. Defendants further described this filing as "intended to represent all documentation necessary to support the defendants’ action in this case," and they also reserved the right to refer to any matter previously filed by either party. Id. at n. 1.

In that Defendants have had over eight months since the filing of this lawsuit to assemble the relevant documentation on the dioxin review, Plaintiffs respectfully reserve the right to object to introduction of any additional preexisting agency documentation after today’s date. In addition to being subject to disclosure in this lawsuit, all documents relating to the dioxin review and the 1995-96 listing criteria revisions have been the subject of Freedom of Information Act requests for well over a year, and Defendants have had more than sufficient time and opportunity to make such documentation available.

Moreover, Defendants’ record submission is obviously incomplete to the extent that it omits, and does not incorporate by reference, numerous key documents previously filed in this case. Defendants have left out , for example, the agency’s September 26, 1996 press release, approved by Defendants Shalala and Olden, which states, "The original criteria for listing a substance as a known human carcinogen remain unchanged." (Am. Compl. Exh. 2). Also omitted is the August 1996 Environmental Health Perspectives article confirming that the criteria for the known category listings "are substantially unchanged from the former criteria." (Am. Compl. Exh. 3). Plaintiffs therefore challenge the Defendants’ assertion that their submission contains all of the documentation needed to decide this case. Notice of Filing Administrative Record at n. 1 (Dec. 17, 1999).

Plaintiffs note that Defendants’ December 17 "Record", which consists of 31 separate exhibits ("R. Exh. __"), contains only nine items not previously filed by one or both sides during this litigation.² Compare Plaintiffs’ Index of Exhibits, Affidavits and Declarations filed October 25, 1999. These new items are:

Exh. 3 Second Annual Report on Carcinogens ("RoC") (excerpt)

Exh. 4 Third Annual Report on Carcinogens (excerpt)

Exh. 15 October 2, 1997 Federal Register notice announcing October 30-31, 1997 meeting of RoC Subcommittee of the NTP Board of Scientific Counselors

Exh. 16 Partial transcript (pp. 2-13, 267-340) of the October 31, 1997 RoC Subcommittee meeting³

Exh. 17 Summary minutes, RoC Subcommittee meeting, October 30-31, 1997

Exh. 20 Minutes of April 16, 1998 NTP Executive Committee meeting

Exh. 25 Partial transcript (pp.3, 9-11, 17-85) of the December 2, 1998 RoC Subcommittee meeting⁴

Exh. 27 December 14, 1998 Federal Register notice calling for public comment on listing of eleven substances, including dioxin

Exh. 28 Summary minutes of NTP Executive Committee meeting held February 24, 1999

In support of their motion for summary judgment, Plaintiffs raised a series of key factual questions that, to the best of Plaintiffs’ knowledge, have gone unanswered. See Pl. S.J. Mem. at 27-29. Having now reviewed what Defendants assert is "a true and accurate copy of the administrative record in this case," Plaintiffs remain at a loss.

There appears to be no discussion in the record, for example, of where the agency explained and justified its departure from the long-standing position that sufficient epidemiologic evidence is required for listings in the known human carcinogen category. Nor does there appear any discussion in the public administrative record addressing the mixtures/confounding issue.

In order for the Court to find that Defendants’ proposed dioxin listing is not arbitrary and capricious, Defendants must point to evidence in the record upon which such a listing could reasonably be predicated. The absence of such information in the record that Defendants have filed, as evidenced by the lack of answers to the key questions Plaintiffs have raised, supports Plaintiffs’ contentions that the threatened dioxin listing change is arbitrary and capricious.

Since the filing of the last brief in this litigation on December 17, 1999, Plaintiffs have confirmed that the 9^th RoC has been approved by Defendant Olden and has been transmitted to the Office of the Secretary for review and approval. Neither Defendants nor HHS officials with whom counsel for Plaintiffs spoke this past week has indicated that the proposed "known human carcinogen" upgraded listing for dioxin has been changed in the draft report presented to the Secretary.

As explained below, Plaintiffs object to certain assertions in Defendants’ Statement of Material Facts With Respect to Which There is No Genuine Dispute ("Def. Facts"). Some of these statements are misleading, and some are simply false. While Plaintiffs’ objections demonstrate the inappropriateness of granting summary judgment for Defendants (see Fed. R. Civ. Pro. Rule 56), the objections do not raise any factual dispute that would prevent summary judgment in favor of Plaintiffs.

Plaintiffs contest one or more statements from the following paragraphs of Defendants’ Statement of Material Facts:

Para. 10: Defendants assert, "Nowhere during the discussions of mechanistic data was it agreed or decided that such data should be used only for the ‘Reasonably Anticipated’ and not for the ‘Known’ category." (Def. Facts at 4). This statement is misleading. A correct factual statement would be that, during the various review discussions leading up to the criteria revisions in 1996, whenever specific changes to the existing criteria for the "known" category were discussed, there was no discussion of -- much less agreement on -- using mechanistic data to compensate for "limited" epidemiologic evidence (i.e., evidence from studies in humans).

Nor was there ever any discussion of using data from animal experiments or in vitro data in such a fashion. While the minutes of the review meetings do contain several references to consideration of mechanistic data, these references do not indicate any intent to revise the "known" category to incorporate mechanistic, animal, or in vitro data. Taken in the context of the review meeting minutes, it is clear that the scientists considered incorporating mechanistic and animal data only for the "reasonably anticipated" category. The structure and the wording of the September 26, 1996 Federal Register notice (Am. Compl. Exh. 1), the contemporaneous agency press release approved by Defendants Shalala and Olden (Am. Compl. Exh. 2), and the HHS journal article authorized by them (Am. Compl. Exh. 3) all confirm this conclusion.

Para. 11: The statement is made that,"as printed", the final explanatory paragraph of the revised listing criteria "had wider margins than either of the two specific listing categories." (Def. Facts at 4). This statement is not true with regard to the Federal Register notice that announced the criteria revisions. In the Federal Register notice, the explanatory paragraph (actually called a "descriptive paragraph") has the same margins as the rest of the notice, and it follows -- without a textual break -- the heading "Revised BRC Criteria Reasonably Anticipated To Be Human Carcinogens" (italics as in original). See Am. Compl. Exh. 1.

Para. 14: This paragraph is misleading in its entirety. The minutes do not reflect that the "participants discussed" this subject, nor that Dr. Barrett "stated" that mechanistic data could be used to compensate for a lack of convincing epidemiological evidence. See Def. Facts at 5. The full relevant portion of those minutes states:

Dr. Lucier stated that a point of discussion might be whether there could be compelling mechanistic data that would allow a chemical to be classified a human carcinogen even though it may lack good epidemiologic data. Dr. Carl Barrett, NIEHS Scientific Director, contended that a chemical or agent could be placed in Category 1, lacking convincing epidemiologic evidence, if there was a consensus of experts that available mechanistic data strongly supported the chemical being a human carcinogen.

R. Exh. 7 at 5 (emphasis added). There is no indication of further discussion or that others agreed with Dr. Barrett. Thus, Defendants’ asserted "material fact" is really nothing more than a proffered discussion topic and the contention of one committee member, a contention that the criteria review committees ultimately rejected. See discussion, infra, at pp. 24-25.

Para. 15: This paragraph implies that the quoted listing criteria language is taken from the Federal Register notice of September 26, 1996. It is not. As presented in Defendants’ brief, the margins have been altered from the Federal Register format so as to support Defendants’ formatting argument. Additionally, the italics indicating revisions made to the previous criteria have been omitted, as has the following sentence immediately preceding the disputed final paragraph:

The following descriptive paragraph has been added to the criteria:

Defendants allege that Plaintiff Brevet does not satisfy any of the three prongs for Article III standing. Def. S.J. Mem. at 4-9. As in their earlier briefing (Def. Reply at 6-7)⁵, Defendants give slight treatment to the third prong -- redressability. See Def. S.J. Mem. at 8-9. Plaintiffs have previously dispensed with this argument (see Pl. S.J. Mem. at 4 n. 2), and it remains beyond question that the Court has authority to issue either injunctive or declaratory relief that will redress the threatened harm to plaintiffs.⁶ The crux of Defendants’ standing argument therefore remains that the Plaintiffs (now including Brevet) do not satisfy either the "injury in fact" test or the "fairly traceable" test.

In order to defeat Defendants’ motion for summary judgment on standing grounds, Plaintiffs need not offer proof of their standing. Natural Resources Defense Council, Inc. v. Jamison, 787 F. Supp. 231, 237 (D.D.C. 1990). Plaintiffs are entitled to all favorable inferences in this regard, and Plaintiffs "need only present sufficient evidence from which the court can infer the existence of the constitutional elements of standing." Id.

Defendants first argue that the threatened injuries to Brevet do not rise to the level of "injury in fact" necessary to support standing. (Def. S.J. Mem. at 5-6). In combination with their later comments on causation, Defendants’ argument ultimately boils down to the following: (1) any anti-PVC regulation or loss of Brevet’s customers which has not already occurred is necessarily too "speculative" to support standing, but (2) any injury that already has occurred cannot support standing because such injury is proof that the proposed dioxin listing did not cause the harm. Defendants want to have it both ways.

Thus, Defendants argue that because the San Francisco area municipal resolutions have yet to inflict -- in Defendants’ words -- a regulatory "bite", these and similar threatened initiatives should carry no weight in the standing analysis. Defendants rest this argument on the interim status of the Bay Area restrictions and the claim that the prospect of a "binding law" affecting PVC sales is "completely speculative." The overlooked point here, of course, is that publication of the RoC dioxin listing as proposed would provide enormous political and scientific pressure for these and other municipalities to take direct action against PVC products, including Brevet’s, and put pressure on suppliers and users to de-select Brevet’s products. Again, Defendants would have the Court adopt a wait and see approach before determining whether a sufficiently serious injury will occur.

Tossed into the middle of Defendants’ argument is the misstatement, "Brevet has not alleged that it has lost any business at present." This statement is false. As Brevet’s owner clearly indicated in his affidavit, some of Brevet’s major customers have already begun to move away from PVC products due to public, shareholder and political pressures. Affidavit of Charles Brewer (Pl. S.J. Mem. Exh. 1) at ¶ 8.

Moreover, Defendants’ argument cannot stand in light of evidence Plaintiffs have previously submitted documenting the real activities of real organizations in Brevet’s home state bent on the complete elimination of PVC products from the marketplace. See Pl. S.J. Mem. Exhs. 4, 5, 6. Indeed, the "Zero Dioxin Alliance" has scheduled a public rally in Oakland, California, for Wednesday, February 23, 2000 -- just two days before oral argument in this case -- to build on the municipal resolutions. See Pl. S.J. Mem. Exh. 4 at "3 of 4".

This past week, the Supreme Court clarified that "injury in fact" necessary to support standing may be based on an affiant's "reasonable concerns about the effects of" the threatened harm. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,___ U.S. ___, 2000 WL 16307 at * 11 (Jan. 12, 2000). Here, it is more than reasonable for Brevet to be concerned about the explosive effects of the proposed NTP dioxin listing on the already volatile anti-PVC climate in Brevet’s home state. Defendants’ cold retort that, "Brevet may thus conceivably be engaged in an industry that has a limited future" (Def. S.J. Mem. at 5), demonstrates the reasonableness of Brevet’s concern.

Injury in fact may be found where, as discussed in section III.A.2 below, the harm occurs through a third party. The Supreme Court has recognized that where events similar to those that threaten the alleged harm have taken place in the past, the finding of requisite injury to support standing in a "three-party" threatened injury case is more easily justified. See Blum v. Yaretsky, 457 U.S. 991, 1001 (1982) ("in light of similar determinations already made by the committee of physicians chosen to make such assessments . . . threat [of injury was] quite realistic"). Where the existence of injury is at issue in the three-party case, the question "usually turns on a determination of ‘how likely it is that the third party’s response to the challenged governmental action will injure the plaintiff at all’". NRDC v. Jamison, supra, 787 F. Supp. at 234 (holding environmental group had standing to challenge rules affecting leasing and mining of federally owned coal) (emphasis in original) (quoting Wilderness Soc’y v. Griles, 824 F.2d 4, 12 (D.C. Cir. 1987)).

Defendants’ second standing argument is that the threatened harm to Brevet is not "fairly traceable" to the publication of the proposed dioxin listing in the RoC. This argument also fails.

Defendants seem not to appreciate the political reality of the situation. As Plaintiffs have previously described (Pl. S.J. Mem at 7-8 & Exhs. 4, 5, 6), influential activist groups are poised, once the 9^th RoC is released, to move even more aggressively than in the past against businesses allegedly associated with dioxin, including Brevet’s. Local governments and Brevet’s own customers will be forced to react to these pressures. This scenario is not mere "speculation", as Defendants repeatedly charge, but a highly probable outcome, one evidenced forcefully by recent events.

The D.C. Circuit has long recognized that to meet the constitutional standing requirement that the harm be "fairly traceable" to the defendant’s action, the harm may be inflicted through intermediate third parties. See, e.g., National Wildlife Federation v. Hodel, 839 F.2d 694, 705-06 (D.C.Cir.1988) ("mere indirectness of causation is no barrier to standing, and thus, an injury worked on one party by another through a third party intermediary may suffice."); Public Citizen v. Lockheed Aircraft Corporation, 565 F.2d 708, 717 n. 31 (D.C.Cir.1977) ("We are concerned here not with the length of the chain of causation, but on [sic] the plausibility of the links that comprise the chain.") This is no less true when the harm arises from administrative conduct that provokes a strong public reaction. See, e.g., Block v. Meese, 793 F.2d 1303, 1309 (D.C.Cir.), cert. denied, 478 U.S. 1021 (1986) (plaintiff had standing to challenge Department of Justice classification of films as political propaganda, although alleged injury occurred only through irrational public perception of label). See also International Union of United Auto., Aerospace & Agric. Implement Workers of Am. v. Brock, 783 F.2d 237, 247 (D.C.Cir.1986) (unions satisfied "fairly traceable" requirement of Article III standing in challenging Department of Labor decision which effectively modified an intermediary employer's legal reporting obligations); National Comm. to Preserve Social Security v. Bowen, 735 F. Supp. 1069, 1081 (D.D.C. 1990) (holding presence of employer as intermediary in causation chain insufficient to deny necessary causation to establish standing in suit against Social Security Administration).

Defendants briefly elaborate on the three-party standing doctrine, citing Animal Legal Defense Fund v. Glickman,154 F.3d 426, 443 (D.C. Cir. 1998), and Telephone and Data Systems, Inc. v. FCC, 19 F.3d 42, 47 (D.C. Cir. 1994), for the proposition that injurious private conduct is fairly traceable to the administrative action if that action "permitted", "allowed", or "authorized" the conduct, or "established its legality." (Def. S.J. Mem. at 6). While the D.C. Circuit never stated that such a showing is required to support standing⁷, it is clear that the publication of the proposed dioxin listing would meet even this standard. Unless and until the proposed listing is finalized, it remains a false statement to assert that NTP has formally concluded that dioxin is a known human carcinogen. The publication of such a false statement with the intent to deceive could be actionable under any number of circumstances, such as the submission of comments to a local government body or for the purpose of defaming a private business. With the issuance of the proposed RoC, however, anti-dioxin groups will be free to trumpet this new government finding. Defendants’ actions thus "permit" or "allow" conduct that might otherwise be sanctionable.

Defendants cite Microwave Acquisition Corp. v. Federal Communications Comm’n, 145 F.3d 1410, 1412 (D.C. Cir. 1998), as a case where the court held that the plaintiff lacked standing because the alleged third party conduct was "too attenuated" to support standing. (Def. S.J. Mem. at 8). In that case, however, the third party action constituted an alleged breach of contract for the purchase of a communications company that the plaintiff company had wanted to buy. The court held that the FCC’s approval of the sale of the desired company to another buyer could not have caused the breach of contract, because the seller had indicated an intent to breach even before the FCC approval was sought. Unlike here, no evidence was presented indicating that the decision of the third party to commit the act harmful to plaintiff -- in that case, the alleged breach -- was caused by the third party’s consideration of the government action. The case is therefore not similar to the one at hand.

In an attempt to downplay the effect of the RoC’s publication on real world events, Defendants note that the San Francisco area governments cited the NTP as "one of over 20 references" in support of the anti-dioxin resolutions. (Def. S.J. Mem. at 5, 7). The argument follows that NTP is merely one of many authorities to speak on the dioxin issue, and issuance of the report therefore will have no tangible effect on the public.

Defendants are too modest. While it is true that a number of diverse authorities were cited in the California resolutions, this fact simply points up how critical a "known" human carcinogen finding from the country’s premier health agency would be.⁸ Surely Defendants do not deny their intent that the RoC listings be made widely known. One of the fundamental purposes of the statute creating the RoC was to make the public aware of the presence of confirmed or potential carcinogens in their surroundings. See H.R. Rep. No. 95-1192, 95^th Cong., 2d Sess., at 22 (1978) (Mot. Dismiss Exh. 1 at 22) ("a considerable amount of cancer can be prevented or at least detected early if more people become aware. . . .") Thus, even a preliminary decision of the NTP Board of Scientific Counselors -- a decision that was later reversed -- received prominent reference in the Bay Area resolutions. No imagination is necessary to appreciate the effects of the proposed NTP dioxin listing, disseminated immediately on the Internet and amplified manyfold by activist groups, on the current anti-PVC climate. Brevet therefore stands directly in harm’s way.

As in their Opposition to the Application for Preliminary Injunction, (Def. P.I. Opp. at 33), Defendants rely heavily on Wisconsin Gas Co. v. Federal Energy Regulatory Comm’n, 758 F.2d 669, 674 (D.C. Cir. 1985), for the assertion that Plaintiffs must demonstrate injury that is "certain and great; . . . actual not theoretical." (Def. S.J. Mem. at 27). Defendants contrast this supposedly applicable standard with the threatened harm to Plaintiffs in this case, which Defendants again dismiss as "speculative." Id.

There are at least two reasons why Defendants’ invocation of Wisconsin Gas is unavailing. First, the seemingly absolute standard above is tempered significantly later in the D.C. Circuit’s opinion. As Defendants themselves note (Def. S.J. Mem. at 28) the court in a later passage acknowledges that a party need not always show that the threatened harm is certain to occur. Thus, even under Wisconsin Gas, if such harm has previously occurred in the past, a party need show only that it is likely to occur again. 758 F.2d at 674.

Here, Plaintiffs have demonstrated that the threatened harm has occurred in the past with respect to both categories of Plaintiffs. In the case of the restaurant Plaintiffs, such past harm was clearly demonstrated last year when European restaurants suffered supply shortages and lost sales resulting from government pronouncements of widespread dioxin contamination in the food supply. Plaintiffs attached several news articles and other exhibits to their Opposition to Defendants’ Motion to Dismiss that documented vividly this actual harm. See Pl. Opp. Exhs. 10, 13, 14, 15, 16, 18. With respect to Plaintiff Brevet, the past harm is demonstrated by the fact that some of Brevet’s own customers have already begun phasing out PVC products -- including Brevet’s -- because of public concern over dioxin and the alleged ties between PVC and environmental dioxin levels. See Affidavit of Charles Brewer (Exh. 1 to Pl. S.J. Mem.).⁹

Second, Defendants’ narrow excerpt from Wisconsin Gas ignores the D.C. Circuit’s long-standing recognition that availability (or unavailability) of a possible compensatory remedy plays a crucial role in the irreparable harm analysis:

The possibility that adequate compensatory or other corrective relief will be available at a later date, in the ordinary course of litigation, weighs heavily against a claim of irreparable harm.

Wisconsin Gas, supra, 758 F.2d at 674 (quoting Virginia Petroleum Jobbers Ass’n v. FPC, 259 F.2d 921, 925 (D.C. Cir. 1958)). As Plaintiffs have previously explained, (P.I. App. at 31-32; P.I. Reply at 21-22), the essence of "irreparable" harm is that such harm is not susceptible of repair through later judicial relief in an action for monetary damages.

Defendants concede that there is no alternative remedy in this case, but they dispute that this has any legal effect:

Plaintiffs argue that they have shown irreparable injury because they will be unable to recover money damages from the government. But this fact alone does not obviate plaintiffs’ need to show "severe economic impact." Bristol-Myers, 923 F. Supp. at 221 (quoting WMATC v. Holiday Tours, Inc., 559 F.2d 841, (D.C. Cir. 1977)).

Def. S.J. Mem. at 30 (emphasis added). However, the D.C. Circuit’s opinion in Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 221 (D.D.C. 1996) -- which admittedly contains the quoted phrase "severe economic impact" on the cited page -- does not support Defendants’ claim that absence of judicial remedy plays no part in the showing of harm required. The unavailability of subsequent judicial remedy was not even discussed in that case.¹⁰

In support of their motion for summary judgment, Defendants reiterate arguments on the merits substantially identical to those made in opposing Plaintiffs’ application for preliminary injunction on September 28, 1999. As Plaintiffs explained in their own summary judgment brief (Pl. S.J. Mem. at 21-27), Defendants’ arguments fail for the reasons previously articulated in Plaintiffs’ October 8, 1999 reply brief in support of the motion for injunction.

While Defendants could not know what arguments Plaintiffs would raise in their December 17 filing, Defendants made virtually no attempt in their latest brief to add to their previous arguments on the merits and no attempt whatsoever to respond to Plaintiffs’ October 8 reply brief.¹¹ Defendants’ most recent argument in defense of their inaccurate presentation of the scientific evidence, for example, is merely a lightly edited reproduction of material from their opposition to the application for preliminary injunction. Compare Def. S.J. Mem. pp. 23-26 with Def. P.I. Opp. pp. 29-32.

Today’s brief is thus the second in a row that Plaintiffs have filed without knowing how or whether Defendants would respond to Plaintiffs’ October 8 reply brief. Defendants presumably will present their counter-arguments, if any, in today’s simultaneous filing. Failing that, Plaintiffs will assume that Defendants have no response to the merits discussion set forth in Plaintiffs’ earlier reply brief and that, in effect, Defendants admit that their conduct was arbitrary and capricious as therein described.

The few new, or nuanced, points that Defendants have raised in their December 17, 1999 summary judgment filing are addressed below.

According to Defendants, the final descriptive paragraph of the revised 1996 listing criteria allows listings of substances in the RoC based on "scientific judgment" and taking into consideration "all relevant evidence". Defendants’ entire argument on the merits depends on the Court’s ruling that this paragraph applies to the "known" human carcinogen criteria.

Defendants’ latest brief adds little to the previous discussion, however. Defendants repeat, for example, the argument raised in their opposition to the application for injunction regarding placement of the descriptive paragraph either above or below the two categories. (Def. S.J. Mem. at 16-17; Def. P.I. Opp. at 22-23). Internal HHS drafts reflecting that the paragraph was moved from the bottom of the criteria to the top to the bottom again do not support Defendants’ argument. At most, these drafts indicate only that HHS considered, but rejected, a format that might have made the paragraph appear to apply to both categories.

As Plaintiffs noted in their summary judgment papers, Plaintiffs’ reply brief in support of their application for preliminary injunction provides a detailed examination of the final descriptive paragraph accompanying the 1996 revised listing criteria, including the drafting history and other records surrounding that provision. The Court is therefore respectfully referred to that earlier submission. See P.I. Reply at 5-12.

Defendants raise an issue whether, in revising the listing criteria in 1995-96, the agency and the scientists participating in the criteria revision intended to include mechanistic data in the kinds of data that may be considered in listing substances in the known human carcinogen category.¹² Regrettably, the record in this regard leaves some room for creative mischief, clever lawyering, and retrospective obfuscation.

It is important to bear in mind that, at the time the criteria were being revised, the principal question before the committees was whether mechanistic data -- an emerging and occasionally controversial type of evidence -- should, for the first time, be considered in listing substances in the RoC at all. Prior to the 1996 revisions, such data were not even mentioned as a possible basis for a listing in the RoC. R. Exh. 13. At the conclusion of the criteria revisions, mechanistic data did limp onto the stage under the reasonably anticipated criteria as the last of many factors to be taken into account.

In this context, general statements announcing that consideration of mechanistic data would be allowed "for the listings in the RoC" or "in the selection process" (see, e.g., Def. S.J. Mem. at 16) take on an entirely different meaning from what Defendants would have the Court believe. Yes, mechanistic data were now to be considered "for RoC listings." However, the failure of these statements to go on to explain in every instance that the "listings" at issue are the reasonably anticipated listings is perfectly understandable.

For example, the statement from the Environmental Health Perspectives article that mechanistic data may be considered "in determining whether to list a substance" (Def. S.J. Mem. at 19) (emphasis Defendants’) merely implies that consideration of such data is appropriate in deciding whether or not to list the substance in the RoC at all, i.e., whether to list it as a reasonably anticipated carcinogen or not to list it anywhere.

Defendants cite "generally" (Def. S.J. Mem. at 16) to the records of the three break-out groups that specifically addressed the possible "incorporation of mechanistic data as part of the criteria for listing substances in future reports." Id.; R. Exh. 5 at 2. The critical point that Defendants seek to avoid, however, is that, after considering the issue, these groups recommended not to allow inclusion of mechanistic data in "category 1" (the known category).

Group 1, for example, recorded its discussion on whether to expand the known criteria as follows:

Discussion focused on whether any other information (e.g., animal data) besides "sufficient evidence of carcinogenicity from humans" could be used to list an agent in category one. This was found not to be the case. (Known is known).

NTP Ad Hoc Working Group, Group 1 Report at 3 (part of P.I. Opp. Exh. 4) (emphasis added). Similarly, the summary minutes combining the conclusions of all the working groups state:

In summary, it was the recommendation of breakout groups 1 & 3 that the existing two categories of the current criteria for listing substances in the BRC should remain with revisions to category 2 ["reasonably anticipated"] to allow for all scientific evidence to be considered. This will allow for the best scientific judgment to be used in consideration of substances for listing in the BRC.

R. Exh. 5 at 3 (emphasis added).

Hence, two out of the three groups expressly recommended that there be no change to the criteria for the known category.¹³ Nowhere does the record indicate that any of the three groups recommended that mechanistic data be used to support known human carcinogen listings.

Likewise, the statements of Dr. Lucier and Dr. Barrett at the June 29, 1995 NTP Executive Committee meeting do not in any way indicate that the Executive Committee approved the used of mechanistic data for consideration in known carcinogen listings. As noted above in addressing Defendants’ asserted Statement of Material Facts, the full relevant portion of those minutes states:

Dr. Lucier stated that a point of discussion might be whether there could be compelling mechanistic data that would allow a chemical to be classified a human carcinogen even though it may lack good epidemiologic data. Dr. Carl Barrett, NIEHS Scientific Director, contended that a chemical or agent could be placed in Category 1, lacking convincing epidemiologic evidence, if there was a consensus of experts that available mechanistic data strongly supported the chemical being a human carcinogen.

R. Exh. 7 at 5 (emphasis added). Nowhere does the record indicate that there was further discussion of the proposal or that others agreed with Dr. Barrett. Defendants therefore confuse a proffered discussion topic and the contention of one committee member with actual agreement that mechanistic data would be considered for "known" category listings. Plaintiffs again challenge Defendants to come forward and point to evidence indicating that the NTP Executive Committee ever agreed to such a dramatic revision to the listing criteria.

Plaintiffs noted in their summary judgment brief that Defendants had failed in two key respects to address errors and omissions in their presentation of the scientific record pertaining to the dioxin listing. See Pl. S.J. Mem. at 27. First, as discussed in their reply brief in support of the application for preliminary injunction (P.I. Reply at 16-18), Defendants have yet to explain their inaccurate and substantial reliance on the IARC Monograph and the 1997 and 1998 Bertazzi, et al. articles to support the proposed dioxin listing.

Second, during the course of the dioxin review, Defendants disregarded an important aspect of the evidence on causality by failing to address the effect of worker exposure to chemical mixtures containing dioxin as a contaminant along with other potential carcinogens. (P.I. Reply at 18-19). Defendants thus have failed to address confounding as an important aspect of the listing decision.¹⁴ (P.I. Reply at 19). Unless this wholesale oversight of these critical scientific questions is soon remedied, the Court should conclude that the absence of any reasonable explanation constitutes arbitrary and capricious agency action. See Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co. 463 U.S. 29, 43 (1983).

The remaining considerations for issuance of an injunction against publication of the proposed dioxin listing -- the balance of harms between the parties and the question of public interest -- weigh heavily in Plaintiffs’ favor. Defendants’ summary judgment brief substantially repeats the arguments raised in their opposition to the preliminary injunction. See Def. S.J. Mem. at 32-33; Def. P.I. Opp. at 38. As Plaintiffs have previously discussed (P.I. App. at 37-40; P.I. Reply at 23-24), Defendants have nothing to lose, and the public has much to gain, from an Order of this Court granting the relief Plaintiffs request.

As described above, Defendants have failed to set forth undisputed facts that would entitle them to summary judgment as a matter of law. Significant flaws in Defendants’ legal arguments, including their jurisdictional arguments, also indicate that summary judgment in Defendants’ favor is not warranted. By contrast, Plaintiffs have stated, and fully documented, grounds for summary judgment in their favor.

For the foregoing reasons, Defendants’ Renewed Motion to Dismiss and/or for Summary Judgment should be denied, and Plaintiffs’ Motion for Summary Judgment should be granted.

Respectfully submitted,

_____________________________________

CHARLES J. FROMM, DC Bar No. 420021
Multinational Legal Services, P.C.
11 Dupont Circle, Suite 700
Washington, DC 20036
Ph: (202) 797-7124
Fax: (202) 939-6969

Attorneys for Plaintiffs

Dated: January 17, 2000

¹ Plaintiffs use the following abbreviations throughout this filing to refer to previous briefing:

Mot. Dismiss- Defendants' Memorandum in Support of Motion to Dismiss Pl. Opp.- Plaintiffs' Mem. in Opposition to Motion to Dismiss Def. Reply- Defendants' Reply to Plaintiffs' Opp. to Motion to Dismiss P.I. App.- Plaintiffs' Mem. in Support of Appl. for Prelim. Injunction Def. P.I. Opp.- Defendants' Opp. to Plaintiffs' Appl. for Prelim. Injunction P.I. Reply- Plaintiffs' Reply to Defendants' Opp. to Appl. for Prelim. Injunction Pl. S.J. Mem.- Plaintiffs' Mem. in Support of Mot. for Summary Judgment Def. S.J. Mem.- Defendants' Mem. in Support of Mot. for Summary Judgment

² A tenth item, "record" Exh. 27, consists of summary minutes from the December 2-3, 1998 Report on Carcinogens Subcommittee meeting. Defendants filed a substantially identical version of this document the day after their Opposition to Plaintiffs' Application for Preliminary Injunction.

² Transcript pages 25-36 to the October 31, 1997 RoC Subcommittee meeting, which contain the testimony of Dr. Ray Greenberg opposing the upgraded listing for dioxin, were submitted as Exh. 14 to Plaintiffs' Application for Preliminary Injunction. Pages 7-8 were previously submitted as Exhibit 12 to Defendants' Opposition to the Application for Preliminary Injunction. The vote of this committee, in favor of listing dioxin as a know human carcinogen, was subsequently reversed in December 1998 after Defendant Olden ordered a re-review.

³ Transcript pages 10-11 were submitted previously as Exh. 13 to Defendants' Opposition to the Application for Preliminary Injunction.

⁴ Defendants did not raise the non-redressability argument in their motion to dismiss.

⁵ Defendants' new citation to University Medical Center v. Shalala, 173 F.3d 438 (D.C. Cir. 1999), in support of their non-redressability argument is inapposite. In that case, the plaintiff hospital argued that drug manufacturers had deprived the hospitals of discounts because HHS had wrongly excluded the hospitals from a list of eligible institutions. The court held that plaintiffs' injuries had been caused by the drug manufacturers' failure to provide the discounts and could not be redressed retroactively by a declaration that plaintiffs had been eligible for the discount during the relevant time period. Id. at 441-42. Here, the relief sought is entirely prospective and the threatened injuries are clearly redressable by this Court.

⁶ The Telephone and Data court said that the administrative action would be fairly traceable if -- not "only if" -- such action authorized the private conduct or established its legality. 19 F.3d at 47.

⁷ Notably, the San Francisco area municipal resolutions list the NTP as one of the first citations in support of their action, even though the NTP action was only a preliminary and partial finding. The finding would undoubtedly be given significantly greater prominence if it were officially confirmed as a final authoritative government pronouncement.

⁸ Defendants state (Def. S.J. Mem. at 5, 7-8 & n.4) that Plaintiffs have failed to allege that any Brevet customers have actually discontinued purchases from Brevet because of concerns over dioxin. This is not true. Plaintiffs state that Brevet has not asserted a loss of business from Tenet Healthcare. However the Tenet article attached to Mr. Brewer's affidavit lists several healthcare companies in addition to Tenet that are phasing out PVC. As Mr. Brewer indicated in his affidavit, some of these companies are major customers of Brevet's. Brevet Affid. (Exh. 1 to Pl. S.J. Mem.) at 8.

⁸ Defendants overlook other injunction cases from this jurisdiction where courts have stressed the unavailability of subsequent judicial remedy in considering the nature of "irreparable harm" See, e.g., Patriot v. United States Dept. of Housing and Urban Dev., 963 F. Supp. 1, 5 (D.D.C. 1997) (finding irreparable harm from damage to business reputation); Holland v. Frank V. Carlow Irrevocable Trust, 176 F.R.D. 416, 418 (D.D.C. 1997) (finding irreparable harm where defendants would be judgment-proof); TEAC America, Inc. v. United States Dept. of Navy, 876 F. Supp. 289, 294 (D.D.C. 1995) ("The irreparable harm inquiry in a disappointed bidder case is not nearly so straightforward . . . because . . . the losing bidder is prevented by law from suing for lost profits.").

⁹ There is no citation to Plaintiffs' October 8, 1999 reply brief in Defendants' summary judgment papers.

¹⁰ The issue of the minutes is important because the review committees -- composed largely of preeminent independent scientists -- formed the foundation upon which the agency's subsequent revisions to the criteria were based. To the extent that individual agency officials had hoped for a different outcome in 1995 with respect to the committees' recommended use of mechanistic data, that disappointment may have been reflected in subsequent linguistic attempts to cloud the agency's own record.

¹¹ The one group that did recommend a change to the known carcinogen listing category -- group 2 -- recommended that the evidence supporting a "known" classification be explicitly stated to be "epidemiological evidence". Summary Report of Breakout Group 2 at 2 & Attachment I (Def. P.I. Opp. Exh. 4).

¹² The issue is important because the critical studies that evidently form the basis of Defendants' listing decision were of high level worker exposures that apparently no longer occur in the United States, a statutory prerequisite for any RoC listing. See 42 U.S.C. § 241(b)(4). By contrast, the proposed dioxin listing is based primarily on the allegedly widespread dioxin contamination of the food supply. See Am. Compl. Exhs. 15, 16.