IN THE UNITED STATES COURT OF APPEALS
FOR THE DISTRICT OF COLUMBIA CIRCUIT

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

Attorneys for Appellants

Dated: December 11, 2000

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TABLE OF CONTENTS

Introduction

Argument

The core issue of this litigation is whether the Appellees (collectively, the "agency")⁽¹⁾ violated the Administrative Procedure Act, 5 U.S.C. § 706, by relying on improper evidence to list dioxin as a "known human carcinogen" in the 9^th Report on Carcinogens ("9^th RoC"). Importantly, this case is not an inquiry into the scientific database for dioxin, an unwanted byproduct of certain medical waste incineration and other combustion and natural processes. Appellants do not ask the Court to offer a scientific opinion on carcinogenicity or to "second guess" the agencies' evaluation of the relevant evidence. Rather, the Court is asked to determine, under the agencies' published criteria, what that relevant evidence is.

I. The Factual Background Underscores the Magnitude of the Policy Change The Agency Is Advancing.⁽²⁾

Beginning in 1978, the Public Health Services Act, 42 U.S.C. § 241(b)(4), required the Department of Health and Human Services ("HHS") to list "known" or "reasonably anticipated" human carcinogens in the Report on Carcinogens ("RoC").⁽³⁾ HHS developed strict criteria for RoC listings, which were first promulgated in December 1982.⁽⁴⁾ The 1982 criteria permitted listings in the known human carcinogen category only where:

There is sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship between the agent and human cancer.

R. Exh. 13 at 50499 (3d col.). Twenty-six substances were classified as known carcinogens up through the 7^th RoC in 1994. P.I. App. Exh. 1 at Appendix G. The agency listed dioxin in the reasonably anticipated carcinogen category beginning with the 2d RoC in 1982, and it has remained in this lower-tier category in all of the RoCs published since that time. Id. at 195.

Prior to 1996 only two types of data were considered for RoC listings: (i) human epidemiological data, and (ii) studies from experimental animals. The agency ranks evidence from human epidemiological studies as superior to evidence from studies in experimental animals.⁽⁵⁾ It is this higher predictive value that makes epidemiological data the gold standard in human cancer hazard classification and the reason that, prior to the proposed dioxin listing, the agency always insisted on "sufficient" epidemiological data as a basis for listing a substance in the known human carcinogen category.⁽⁶⁾

For each known carcinogen listing during this period, the agency made an affirmative determination that there was sufficient human epidemiological evidence to demonstrate a causal relationship. Even if the experimental data clearly showed carcinogenicity in animals, the substance could not be listed in the known human carcinogen category unless there was also sufficient human epidemiological data.

From 1994 to 1996, the agency undertook an extensive public review of its listing criteria and process, and on September 26, 1996, published revisions to the listing criteria and procedures in the Federal Register. Am. Compl. Exh. 1. As with the earlier criteria, the revised criteria continued to require that listings in the known carcinogen category be supported by "sufficient evidence from studies in humans which indicates a causal relationship." A formal HHS press release issued the same day as the revised criteria announced, "Updated Criteria Approved For 'Anticipated' Human Carcinogens", but the release noted that "the criteria for listing a substance as a known carcinogen remain unchanged." Am. Compl. Exh. 2. An article published at the same time in Environmental Health Perspectives, the official journal of the NTP, also stated that the criteria for the known category were not being substantively changed. Am. Compl Exh. 3. Both releases were approved by the HHS Secretary and the head of the NTP, Dr. Olden.

In 1998, two years after the promulgation of the revised criteria, the agency published the 8^th RoC. That report listed 29 substances as known carcinogens, and for each of these listings the agency again made an express determination that there was sufficient evidence from epidemiological studies to support the known carcinogen listing. See P.I. App. (Dkt. Ref. 20) Exh. 1 at 1 & § 4. Thus, prior to the proposed dioxin upgrade, the agency had never listed a substance in the known carcinogen category without a finding of sufficient human epidemiological evidence, not even in 8^th RoC, which was issued after the 1996 criteria revisions were adopted.⁽⁷⁾

When a proposal was made to upgrade dioxin to the known carcinogen category, the agency faced a problem. IARC, upon which the agency had previously relied extensively, had recently concluded that there was not sufficient evidence of dioxin's carcinogenicity from studies in humans because the possibility of confounding exposure to other substances could not be excluded. P.I. App. (Dkt. Ref. 20) at Exh. 7, p. 337. The agency nevertheless moved forward with the proposal, asserting that the known carcinogen listing could be based on a "combination" of epidemiological, mechanistic⁽⁸⁾ and animal⁽⁹⁾ data something the agency had never done for any prior listing. See Am. Compl. Exh. 4. Following exchanges of correspondence between the agency and Appellant Tozzi, during which the possibility of litigation was raised, the agency published two April 1999 "clarifications" in the Federal Register (Am. Compl. Exhs. 27, 28), apparently attempting to bolster a newly minted position that the 1996 criteria permitted such a "combination" listing. Appellants filed this suit shortly thereafter.

Thus for the 16 years prior to the 1996 criteria revisions, the agency followed a policy of demanding that sufficient epidemiological data be presented before a substance could be listed as a known human carcinogen. In 1996, in two statements with the concurrence of the HHS Secretary and the NTP Director, the agency said that no substantive changes were being made to the criteria for known carcinogen listings. There has never been an agency statement and explanation that it is changing the criteria for known carcinogen listings.

II. The Agency's Motion for Summary Affirmance Should Be Denied.

A. The Agency Fails to Meet the Standard for Summary Affirmance.

On appeal from a motion or cross-motions for summary judgment, an appellate court's review of all issues raised by either party is de novo.⁽¹⁰⁾ Atlas Air, Inc. v. Air Line Pilots Ass'n, 2000 WL 1694394 (D.C. Cir. Nov. 21, 2000).⁽¹¹⁾ In its motion for summary affirmance, however, the agency attempts to steer the Court away from a de novo review, citing American Horse Protection Ass'n v. Yeutter, 917 F2d 594, 596 (D.C. Cir. 1990), in support of judicial deference to agency action. Agency Mot. at 3. Even in that case, however, the court acknowledged that "deference will, of course, give way when agency action is inconsistent with clear congressional intent or is unsupported by the agency record." Id.

The Supreme Court has instructed that in reviewing an agency action, a court is required to undertake a "searching and careful" review of the facts. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415, 416 (1971); see also 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). Appellants respectfully submit that the "searching and careful" review that Supreme Court requires has never been performed in this case. The Court therefore is urged to examine the facts of the case with a careful and critical eye, including the statements the agency has made concerning the record. Such a review will show that the agency's position is completely unsupported.

The standard for summary affirmance is very high. The party seeking a summary disposition bears the "heavy burden of establishing that the merits of his case are so clear that expedited action is justified." Taxpayer Watchdog, Inc. v. Stanley, 819 F.2d 294, 297 (D.C. Cir. 1987). See also Walker v. Washington, 627 F.2d 541, 546 (summary affirmance granted where claims were "clearly frivolous").

Where the lower court fails to make important factual findings, as it did below, summary affirmance is inappropriate. See Juda v. United States Customs Service, 2000 WL 1093326 (D.C. Cir. 2000) (denying summary affirmance in FOIA case where district court made no finding on segregability and did not request detailed affidavit from agency conducting review). Summary affirmance is likewise inappropriate where, as in this case, the District Court applied an incorrect standard in analyzing the claim. Jackson v. District of Columbia, 1999 WL 728569 (D.C. Cir. 1999) (denying summary affirmance). Because the District Court erred in applying a highly deferential standard without a searching and careful review, this Court should deny the agency's motion for summary affirmance and undertake a de novo review.

Summary affirmance is particularly inappropriate in this case given the need for judicial consideration of the substantial record that was submitted during the year-long proceedings below. In accordance with Fed. R. App. P. Rule 30(c), and by agreement of counsel for both sides, the deferred appendix has not been prepared.⁽¹²⁾ Appellants should be granted a fair opportunity to present their best documentary evidence to the Court in an orderly fashion, through selected record materials and a proper brief under Rule 28. Appellants also request an opportunity to highlight the most telling flaws in the agency's case through oral argument.

Finally, there is no need whatsoever for an "expedited" decision in this case. The agency's unexpected motion does not even hint at an urgency that might support its request for expedited consideration, nor does it cite any precedent suggesting an expedited review is appropriate here. The 9^th RoC has already been published in all respects save for this one disputed listing, and the classification of the disputed chemical in the report pendente lite remains the same as it has been for the past 18 years. Clearly little, if any, harm can come to the agency or to the public by permitting a routine briefing schedule. An expedited review, by contrast, could compromise the "searching and careful" review that is needed and significantly increase the risk of an erroneous decision.

B. The Agency's Application of the Revised Listing Criteria to Dioxin Is Arbitrary and Capricious.

An established maxim of administrative law provides that agency action is arbitrary and capricious if it is not rationally based on adequate consideration of the "relevant factors". Troy Corp. v. Browner, 120 F.3d 277, 288, 293 (D.C. Cir. 1997) (citing Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971)).⁽¹³⁾ Here, the animal and mechanistic data upon which the agency seeks to rely in listing dioxin in the known carcinogen category are exactly the kind of irrelevant factors that Troy and similar cases proscribe.

1. The Lower Court Incorrectly Granted Substantial Deference To the Agency's Interpretation of the Revised Criteria.

As Appellants stressed in their motion for injunction pending appeal, courts are not to accord deference to an agency's interpretation of its own rule where that interpretation is contrary to "other indications of the Secretary's intent at the time of the regulation's promulgation." Gardebring v. Jenkins, 485 U.S. 415, 430 (1988). The District Court therefore erred in granting the agency deference in its interpreting its criteria. Op. at 10.

The agency does not challenge this legal point but instead cites to other portions of the record in an attempt to avoid application of the rule in Gardebring. First, the agency invokes excerpts of preliminary discussions leading up to final publication of the revised listing criteria. Agency Mot. at 6. These statements, however, reflect not the final and formally published views of the agency itself, but preliminary discussions from nine to seventeen months before the final rule was promulgated. The reason the rule in Gardebring requires the court to look at "other indications of the Secretary's intent at the time of the regulation's promulgation" is that preliminary statements by agency officials may or may not ultimately be adopted in formal agency policy.

Similarly unpersuasive are the agency's citations to statements made significantly after the promulgation of the revised criteria. Statements by agency officials or their counsel made well after a rule's promulgation may reflect mere revisionist justification. See Reuters, Ltd. v. FCC, 781 F.2d 946, 951 (D.C. Cir. 1986) (post hoc rationalizations entitled to no weight); Platt College of Commerce, Inc. v. Cavazos, 796 F. Supp. 22, 26 (D.D.C. 1992) (same).⁽¹⁴⁾

Moreover, in contrast to the two formal agency announcements that Appellants submitted below -- statements authorized by the HHS Secretary and the head of the NTP themselves -- the ad hoc statements the agency cites were made by subordinate officials and did not represent formal positions of the agency. See Paralyzed Veterans of America v. D.C. Arena, L.P., 117 F.3d 579, 587 (D.C. Cir. 1997) ("speech of a mid-level official of an agency . . . is not the sort of 'fair and considered judgment' that can be thought of as an authoritative departmental position.") (quoting Auer v. Robbins, 519 U.S. 452, 462 (1997)).

Unlike either the predecisional or post hoc statements the agency cites, the two critical pieces of evidence supporting Appellants' reading of the criteria were published either on, or within days of, the date the revised criteria were published. The HHS press release and the Environmental Health Perspectives "announcement" article published by NTP, both of which the District Court failed to address, also constituted formal statements of the agency itself rather than opinions of individual subordinate officials.⁽¹⁵⁾ The District Court thus erred when it disregarded this critical contemporaneous evidence of contrary agency intent.

The agency's own explanation of the two contemporaneous exhibits simply strains credulity. Appellants have responded to these arguments recently and see nothing new in the agency's latest presentation. See Pltf. Reply (Dkt. Ref. 67) at 3-7. Appellants again note, however, that the Court should not accept the agency's bootstrap argument under which the agency claims (extraordinary) deference to its reading not only of the revised criteria, but of the contrary contemporaneous evidence itself, the very evidence which shows that deference here is inappropriate.

The Court should thus hold that the District Court committed reversible error by not giving great weight to the contemporaneous evidence of agency intent. This evidence casts serious doubt on the agency's present position and rebuts the presumption of deference. Significantly, in none of the cases the District Court cited as a basis for granting the agency deference was there any evidence of a contrary agency intent at the time of the rule's promulgation.⁽¹⁶⁾ Here, by contrast, such evidence is unmistakable. At a very minimum, the contrary contemporaneous evidence in this case raises a question of agency intent sufficient to preclude summary affirmance.

2. The "Administrative History" and Post Hoc Statements The Agency Cites Do Not Support The Agency's Revisionist Interpretation of the Listing Criteria.

Lacking the formal announcement of a change in policy that it needs, the agency attempts to flood the record with citations to unpublished statements of subordinate agency officials. Agency Mot. at 6-11 While the Court ought not even find these materials relevant, a "careful and searching" review of these materials will show that even they do not support the revisionist position now advanced. When the Court weighs the contemporaneous evidence that Appellants have submitted against the pre-promulgation "administrative history" the agency cites (Agency Mot. at 6-7), the record will show that the agency did not intend known human carcinogen listings to be based on "mechanistic data" in the absence of sufficient epidemiological data. The record statements the agency quotes or cites are, at most, ambiguous and are consistent with the contemporaneous agency statements that only the criteria for only the reasonably anticipated category were being substantively changed. See P.I. Reply (Dkt. Ref. 23) at 7-10.

It is important to bear in mind that at the time the criteria were being revised the principal question before the revising committees was whether mechanistic data -- an emerging and recurrently 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 revision process, mechanistic data did narrowly gain acceptance for use in the reasonably anticipated listings, as the last of three factors to be taken into account for that category. Thus, the agency added a new third paragraph to the reasonably anticipated criteria to provide that a substance could be listed as a reasonably anticipated human carcinogen if "there is convincing relevant information that the agency acts through mechanisms indicating it would likely cause cancer in humans", and if there is less than sufficient evidence of carcinogenicity in humans (or animals). 61 Fed. Reg. at 50499-50500. Taken in this context, general statements announcing that consideration of mechanistic data would be allowed "in the selection process" (Agency Mot. at 6-7), without any reference to their applicability to the known criteria, take on an entirely different meaning from what the agency would have the Court believe.

The agency cites the work of pre-decisional "break-out" work groups that considered the role of mechanistic data in April 1995. See Agency Mot. at 6. The agency fails to point out, however, that these breakout groups recommended not to allow inclusion of mechanistic data in "category 1", the known carcinogen category. See Def. P.I. Opp. (Dkt. Ref. 21) Exh. 4 at Ad Hoc Working Group 1 Report, p. 3; R. Exh. 5 at 3; Pl. S.J. Opp. (Dkt. Ref. 36) at 23-24.⁽¹⁷⁾ The June 8, 1995 Federal Register notice of proposed revisions to the criteria is perfectly consistent with this consensus.

The minutes of the June 29, 1995 Board of Scientific Counselors meeting (R. Ex. 7) maintain this consistency. In discussing the proposed revisions, Dr. Jameson, a member of Dr. Lucier's staff, noted only minor proposed editorial revisions to the known category, stating, "The Working Group stressed that listing under Category 1 [known carcinogens] should be based on human data only." Id. at 4. With respect to proposed revisions to Category 2 (reasonably anticipated), Dr. Jameson stated that the new paragraph under Category 2, which is almost exactly the same as the disputed final paragraph in the revised criteria (see infra, § II.B.3), was simply a revised statement of the last sentence in the then-current statement of the Category 2 criteria. Id.

The minutes of the July 27, 1995 meeting of the NTP Executive Committee show that Dr. Lucier's statement regarding "incorporation of mechanistic data as part of the criteria" pertained to the recommendations of the Working Group, which, as discussed above, proposed use of mechanistic data under Category 2 only. R. Ex. 8 at 3.

The few unambiguous statements in support of the agency's position were made either by Dr. George Lucier, a Defendant in the case below, or by staff under Dr. Lucier's supervision. One prominent exhibit containing such statements, R. Ex. 30, is a Lucier affidavit prepared specifically for this litigation. That post hoc explanation, made three years after promulgation of the agency's revised criteria, is obviously self-serving and does nothing to further the agency's position. It certainly does not constitute "record evidence [that] plainly shows" the validity of the agency's position. See Agency Mot. at 12. Moreover, it is unclear what authority, if any, Dr. Lucier ever had to speak on behalf of the agency with reference to the criteria revisions. This is particularly true with respect to his statements seeming to contradict those authorized by the HHS Secretary and the Director of the NTP at the time the criteria were revised.⁽¹⁸⁾

3. The Final "Descriptive" Paragraph of the Revised Criteria Has Never Applied to Known Carcinogen Listings.

In the face of the plain wording of the known criteria and the contemporaneous agency statements, the agency must somehow convince the Court that the final paragraph of the revised criteria (see 61 Fed. Reg. at 50500, col. 1) applies to the known category listings as well as to the reasonably anticipated. The application of this paragraph to known carcinogen listings was a fundamental factor in the decision below wherein Judge Sullivan held that the agency could rely on "all relevant information" in support of the dioxin listing. Op. at 11. Without the final paragraph containing that phrase, the agency's case fails completely. Yet to support Judge Sullivan's crucial premise the agency cites merely of two oral statements, after the fact, by former Defendant Lucier (R. Ex. 16 at 7; R. Ex. 25 at 10). Agency Mot. at 11. As noted above, Dr. Lucier's non-contemporaneous statements are entitled to little or no weight, particularly when judged against the clear evidence of agency intent at the time of publication and the plain meaning of the Federal Register notice itself.

As Appellants noted in their motion for injunction (at Exh. 12 p. 3), the final paragraph stands squarely within the fourth of four distinct subsections in the 1996 Federal Register notice. Indeed, the agency described its iteration of the revised criteria in that notice as a "point by point comparison". 61 Fed. Reg. at 50499 (2d col. at bottom) (emphasis added). The criteria revisions for the two categories were then discussed in separate subsections, first for known carcinogen listings and then for the reasonably anticipated, in a logical old/new, old/new progression. What could the agency possibly have meant by "point by point comparison" if the agency intended the last paragraph of the revisions -- which is plainly contained in the "Revised Criteria Reasonably Anticipated" subsection -- to somehow apply to the criteria for known carcinogen listings, which were discussed first subsection? This makes no sense.

Contrary to the agency's explanation regarding the movement of the final paragraph in pre-publication drafts from the bottom of the criteria to the top to the bottom again (Agency Mot. at 7-8, 13), the most "logical" explanation is that the agency understood that by placing the paragraph at the top of the criteria, the paragraph might mistakenly be understood to apply to both categories of listings. By returning it to the end of the criteria -- and placing it under the "reasonably anticipated" heading -- that false impression was corrected.

In response to Appellants' observation that allowing "all relevant information" to support known listings (absent sufficient epidemiological data) will impermissibly blur the two categories, the agency tries to confuse the Court with a tautology. Agency Mot. at 12. Merely restating the words of the criteria, however, will not change the fact that expanding the term "sufficient human evidence" to include a combination of limited epidemiological data and mechanistic data will erase any meaningful distinction between the categories, contrary to congressional intent.

Even if the Court were to conclude that the final paragraph applies to both categories, however, the most reasonable reading -- and that consistent with the contemporaneous agency statements -- is that the paragraph still does not allow mechanistic data to support known listings in the absence of sufficient epidemiological data. The reference to "all relevant information" in the final paragraph simply refers to whatever information is relevant to the category for which it is being considered. In the case of the known carcinogen category, mechanistic and animal data are not "relevant." The agency's extraordinary reading of this language as allowing consideration of animal data and mechanistic data for the known category listings became apparent only through the proposed dioxin listing and this lawsuit, together with the agency's April 1999 Federal Register "clarifications".⁽¹⁹⁾ There is nothing in this final paragraph indicating any substantive change in the evidence considered relevant under the criteria for the known carcinogen category.

C. The Agency Never Announced and Provided a Reasoned Justification For Any Substantive Change in Its Long-Established Criteria for the "Known Carcinogen" Category.

As Appellants explained in their motion for injunction pending appeal (at pp. 13-14), an agency change in position on the meaning of a rule or statute, adopted without notice of that change and a reasoned explanation, violates the APA's bar on arbitrary and capricious agency action. The agency does not dispute this legal point, but refers back to the pre-decisional "administrative history" and asserts that the agency "explained its reasons for considering this data in the known category listing." Agency Mot. at 13.

The agency never did anything of the sort. The statements the agency cites suggest at most only that some mid-level agency officials -- principally Dr. Lucier -- personally believed that mechanistic data should be embraced more eagerly than the agency had determined.⁽²⁰⁾ Nowhere did the agency ever tell the public that the agency was making a substantive change in the long-established "known" criteria and provide a reasoned explanation for that change. Moreover, even if the Court were to fully defer to the agency's interpretation of the record, it is clear that the unpublished statements of subordinate NTP officials, which the agency now cites (Agency Mot. at 6-11), were never accompanied by any explanation for the extraordinary change in agency position since advanced.

Certainly there was never any public explanation (until shortly before this suit was filed) that the final paragraph of the listing criteria was intended to apply to both the known and the reasonably anticipated categories. In its September 1996 Federal Register notice, the agency itself referred vaguely to that paragraph as a "descriptive paragraph" rather that as part of the criteria (61 Fed. Reg. at 50500), and it certainly did not state the paragraph applied to the known carcinogen listings. Had the agency intended to undo a 16-year agency policy requiring known carcinogen listings to be supported by sufficient epidemiological evidence, it most clearly did not say so, let alone accompany that statement with a reasoned explanation.

III. Appellants' Motion For Injunction Pending Appeal Should Be Granted.

A. The One Case the Agency Cites Does Not Diminish the Likelihood That Appellants Will Prevail on the Merits.

The agency cites no new case authority in support of its argument that Appellants are unlikely to prevail on the merits. Instead the agency cites Blankenship v. Barnstead, 447 F.2d 1280 (D.C. Cir. 1971), for the proposition that injunction is inappropriate, even where irreparable harm is shown, if the movant does not make out a case on the merits. Agency Mot. at 13.

The D.C. Circuit has held, however, that the factors for injunction interrelate on a sliding scale and must be balanced against each other. CityFed Fin. Corp. v. Office of Thrift Supervision, 58 F.3d 738, 746 (D.C. Cir. 1995) ("If the arguments for one factor are particularly strong, an injunction may issue even if the arguments in other areas are rather weak."). Appellants also note that the Blankenship case pre-dates Washington Metropolitan Area Transit Comm'n v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C. Cir. 1977), where the court held that an injunction may be warranted where, as here, the movant has made a "substantial case on the merits." Id. (emphasis added).

B. Appellants Satisfy the Standard for Irreparable Harm.

The agency relies heavily on Wisconsin Gas Co. v. Federal Energy Regulatory Comm'n, 758 F.2d 669, 674 (D.C. Cir. 1985), for the assertion that Appellants must demonstrate injury that is "certain and great; . . . actual not theoretical." Agency Mot. at 14-15. The agency contrasts this supposedly applicable standard with the threatened harm to Appellants in this case, which the agency dismisses as "speculative", id. at 16, notwithstanding the District Court's contrary conclusion. The agency's narrow excerpt from Wisconsin Gas, however, 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)). The essence of "irreparable" harm is that such harm is not susceptible of repair through later judicial relief in an action for monetary damages.

As in their motion for summary judgment below, the agency concedes that there is no alternative remedy in this case, but they dispute that this has any legal effect:

Appellants 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. WMATC v. Holiday Tours, Inc., 559 F.2d 841, 842-43 (D.C. Cir. 1997) [sic -- should be 1977].

Agency Mot. at 16 (emphasis added). The above quoted language is a slightly modified version of a statement the agency made in its motion for summary judgment below, carefully eliminating the original citation to Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212, 221 (D.D.C. 1996). See Def. S.J. Mem. (Dkt. Ref. 34) at 30. Neither Holiday Tours nor Bristol-Myers supports the agency's 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 these cases.⁽²¹⁾

The agency confuses its inevitably forthcoming formal challenge to Appellants' standing with the irreparable harm test.⁽²²⁾ Brevet has a reasonable concern that the publication of the dioxin listing as proposed will cause it severe economic harm. The point is not whether the harm is too speculative to support standing -- it clearly is not, as Judge Sullivan concluded -- but rather whether that harm is irreparable if it does come to pass. If the harm could not be remedied, as the agency concedes, then it is by definition irreparable.

For the foregoing reasons, the agency's motion for summary affirmance should be denied and Appellants' motion for injunction pending appeal should be granted.

Respectfully Submitted,

________________________________
Charles J. Fromm
DC Bar No. 420021
Multinational Legal Services, PLLC
11 Dupont Circle, Suite 700
Washington, DC 20036
Ph: (202) 797-7124
Fax: (202) 939-6969

Attorneys for Appellants

Dated: December 11, 2000

END NOTES:                                                             

1. Appellees are the U.S. Department of Health and Human Services ("HHS"); the National Institute of Environmental Health Sciences ("NIEHS"); HHS Secretary, Donna Shalala; Director of NIEHS and Director of the National Toxicology Program, Kenneth Olden; and Christopher Portier, Director of the NIEHS Environmental Toxicology Program ("ETP"). Former ETP Director George Lucier was inadvertently named as an Appellee in Appellants' earlier filings. Dr. Lucier, who retired from his position last summer, was a named Defendant in the case below. (back to text^)

2. Appellants here present an abbreviated summary of the key facts and respectfully refer the Court to the Amended Complaint and pp. 1-7 of Plaintiffs' September 8, 1999, preliminary injunction brief (Dkt. Ref. 20) ("P.I. App.") for additional detail.  (back to text^)

3. The statute originally required HHS to publish the RoC annually, but the law was changed to a biennial requirement in 1993, and, in fact, the RoC has been published at irregular intervals.  (back to text^)

4. The agency's criteria for listing substances in the RoC are "rules" under the APA, and the listing decisions themselves constitute reviewable agency action. Synthetic Organic Chem. Mfrs. Ass'n v. Secretary, DHHS, 720 F. Supp. 1244 (W.D. La. 1989).  (back to text^)

5. The agency describes epidemiological evidence as "the strongest evidence for establishing a relationship" between chemical exposure and carcinogenicity in humans. E.g., 8^th RoC (Exh. 1 to P.I. App. (Dkt. Ref. 20)) at 1.  (back to text^)

6. The term "sufficient" here has a technical meaning, i.e., that a causal relationship has been indicated. See P.I. App. (Dkt. Ref. 20) at 18. This case does not present a simple difference of opinion over whether the quantum of relevant evidence adduced is or is not, in this sense, "sufficient" to support a known carcinogen listing, a question to which the agency's answer would be entitled to substantial deference. The agency concedes that the epidemiological evidence alone is not "sufficient", and instead it seeks to rely on a "combination" of epidemiological, animal, and mechanistic evidence to support the proposed known carcinogen listing. See Agency Mot. at 4.  between chemical exposure and carcinogenicity in humans. E.g., 8^th RoC (Exh. 1 to P.I. App. (Dkt. Ref. 20)) at 1.  (back to text^)

7. For many of the substances listed in the known category, the RoC statements regarding sufficient epidemiological evidence are by reference to "IARC" findings of sufficient evidence "in humans." See, e.g., P.I. App. (Dkt. Ref. 20) Exh. 1, § 4. IARC, the International Agency for Research on Cancer, is an organization within the World Health Organization and uses the term "in humans" to refer exclusively to epidemiological evidence. See P.I. App. (Dkt. Ref. 20) at Exh. 4.  (back to text^)

8. "Mechanistic" or mechanism of action data attempt to explain, on a sub-cellular or "mechanical" level, how cancer comes about. Such studies, which may use either animal or human cells or tissue, are considered less predictive of human carcinogenicity than are epidemiological data, which are derived from studies "in humans".  (back to text^)

9. The agency has wavered during this litigation with respect its position on "animal" data. At times the agency has disavowed the notion that animal data might ever be used to support known human carcinogen listings in the absence of sufficient human data, evidently conceding that even the most strained interpretation cannot squeeze animal data into the term "studies in humans". See Govt. P.I. Opp. (Dkt. Ref. 21) at 20 n. 9; Govt. S.J. Opp. (Dkt. Ref. 37) at 16. The agency's most recent brief, however, reverts to a pro-animal data position, stating that Judge Sullivan "correctly concluded that . . . both animal and mechanistic data" could support known carcinogen listings. Agency Mot. at 4. Their confusion is understandable, given that so much mechanistic data derives from animal studies. Additionally, prior to its position developed for this litigation, the agency never had to distinguish between different types of mechanistic data because all varieties of such data were considered inadequate to support known human carcinogen listings in the absence of sufficient epidemiological data. (back to text^)

10. In a footnote to their brief (Agency Mot. at 2-3 n. 2), the agency disagrees with Judge Sullivan's holding that Appellant Brevet has standing. The agency's standing contention raises a complex issue which is inconsistent with the agency's motion for summary affirmance. In seeking summary affirmance on the merits alone, the agency evidently is inviting the Court to invoke hypothetical jurisdiction, a practice the Supreme Court has ruled unconstitutional. See Steel Co. v. Citizens for a Better Environment, 118 S.Ct. 1003, 1012 (1998). Appellants agree with Judge Sullivan's ruling on Brevet's standing but will contest the District Court's holding that the other Appellants' lack standing as an issue for appeal.  (back to text^)

11. See also Cone v. Caldera, 223 F.3d 789, 793 (D.C. Cir. 2000) (court reviews cross-motions for summary judgment de novo); Frizelle v. Slater, 111 F.3d 172, 176 (D.C. Cir. 1997) (grant of summary judgment reviewed de novo); Shields v. Eli Lilly and Co. 895 F.2d 1463, 1466 (D.C. Cir. 1990) (same).  (back to text^)

12. Fed. R. App. P. Rule 30(c) provides that, when the appendix is deferred, a party must designate the parts of the record it wants included in the appendix when it serves its brief. The Court has yet to set a date for the filing of Appellants' brief.  (back to text^)

13. In Troy, the D.C. Circuit held that EPA acted arbitrarily and capriciously when it listed a substance as toxic in reliance on undocumented tests, in violation of the agency's own "Hazard Assessment Guidelines for Listing Chemicals on the Toxic Release Inventory". Troy Corp. v. Browner, supra, 120 F.3d at 293. The agency action here was similarly arbitrary and capricious because the agency relied on evidence other than "sufficient evidence from studies in humans", as required by the revised RoC listing criteria, to support the known carcinogen dioxin listing.  (back to text^)

14. The agency cites Bigelow v. Department of Defense, 217 F.3d 875, 878 (D.C. Cir. 2000) for the proposition that an agency interpretation presented for the first time in legal briefs is entitled to deference, provided that "there is no reason to suspect that the interpretation does not reflect the agency's fair and considered judgment." Agency Mot. at 11 n. 5. The Bigelow case, however, does not detract from the principle that no deference is due an agency's litigation position if that position is inconsistent with past agency pronouncements. Indeed, the court in Bigelow expressly stated that it had "been pointed to no past practices or pronouncements that are inconsistent with the Defense Department's current interpretation." Bigelow, supra, 217 F.3d at 878. In this case, by contrast, on or about the very day that the revised criteria were published, the agency itself, in two separate publications that were authorized by the HHS Secretary and the Director of NTP, stated unequivocally that the criteria for the known carcinogen listings were not being substantively changed. If ever there was a case with "reason to suspect" that the post hoc reading advanced by agency lawyers "does not reflect the agency's fair and considered judgment", then surely this is it.  (back to text^)

15. In attempting to explain away the damning HHS press release, the agency asserts that the release was "not a quote from, or attributed to, anyone connected with the program." Agency Mot. at 9. In fact, both Secretary Shalala and NTP Director Olden approved the release (as well as the Environmental Health Perspectives article) prior to its issuance, and both of these senior officials are quoted in it. See Am. Compl. Exh. 2.  (back to text^)

16. See Op. at 10-11 (citing Thomas Jefferson Univ. v. Shalala, 512 U.S. 504 (1994), Wyoming Outdoor Council v. United States Forest Service, 165 F.3d 43 (D.C. Cir. 1999); Rollins v. United States EPA, 937 F.2d 649 (D.C. Cir. 1991)).  (back to text^)

17. Two out of the three groups expressly recommended that there be no change to the criteria for the known category. The one group that did recommend a change to the known carcinogen listing category -- group 2 -- recommended that the evidence required to support a "known" classification be explicitly stated as "epidemiological evidence". Def. P.I. Opp. (Dkt. Ref. 21) Exh. 4 (Summary Report of Breakout Group 2 at 2 & Attachment I ). Nowhere does the record indicate that any of the three groups recommended that mechanistic data be used to support known human carcinogen listings.  (back to text^)

18. The public meeting statements the agency cites (Agency Mot. at 8 n. 4) reflect Dr. Lucier's individual efforts to bend the listing criteria to his own desired contours. The entire 1997 review proceedings, including Dr. Lucier's explanation of the criteria, were vacated following instructions from NIEHS Director Olden that NTP conduct a re-review of dioxin. See Am. Compl. Exh. 12. Dr. Lucier's 1998 statement and Dr. Olden's opaque November 2, 1998, letter to Appellant Tozzi were both made after these Appellants became aware of the possibility of litigation over the issue. Accordingly, they are not probative of the agency's intent at the time the revised criteria were issued.  (back to text^)

19. Even these later "clarifications" do not notify the public of any substantive change in the "known" criteria. See Am. Compl. Exhs. 27, 28.  (back to text^)

20. Dr. Lucier, a biologist by training, personally championed a broader use of mechanistic data while at the agency. See, e.g., "Why Not Use It All?" Environmental Health Perspectives, Vol. 107, No. 5, at A232 (May 1999) (P.I. App. (Dkt. Ref. 20) Exh. 2) (Lucier editorial). On occasion, Dr. Lucier was able to insert his individual views into the record, either personally or through his staff, including Dr. Jameson. However, Dr. Lucier was unable to convince the independent scientists on the three ad hoc working groups considering the criteria revisions of the soundness of his approach. See P.I. Reply (Dkt. Ref. 23) at 7-8 (citing record showing that working groups recommended restricting known carcinogen category to substances for which there was sufficient epidemiological evidence); R. Exh. 5. More importantly, Dr. Lucier was unable to convince either the HHS Secretary or the Director of the NTP, both of whom approved the September 26, 1996 HHS press release and the August 1996 Environmental Health Perspectives article stating that the criteria for the known carcinogen category were not being changed. It is telling in this regard that Dr. Lucier, and not his superiors, filed the lone affidavit on behalf of the agency in this case.  (back to text^)

21. The agency overlooks 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.").  (back to text^)

22. The agency's discussion of redressability (Agency Mot. at 17), one of the three prongs in the standing analysis, confirms this confusion. As the District Court concluded, "Plaintiff Brevet is correct that this Court's issuing an injunction might stave off the effects of the attack on dioxin for a time." Op. at 8.  (back to text^)