MOTION FOR INJUNCTION PENDING
MOTION FOR SUMMARY AFFIRMANCE PENDING
NO ORAL ARGUMENT SCHEDULED
IN THE UNITED STATES COURT OF
FOR THE DISTRICT OF COLUMBIA CIRCUIT
|JIM J. TOZZI, et
UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES, et al.,
On Appeal from the U.S.
District Court for the District
of Columbia (Civil Div.)
APPELLANTS' RESPONSE TO MOTION FOR
AFFIRMANCE, AND REPLY TO APPELLEES' RESPONSE TO
MOTION FOR INJUNCTION PENDING APPEAL
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
TABLE OF CONTENTS
Appellants hereby respond to the Appellees' November 27,
2000, motion for summary affirmance ("Agency Mot."). Pursuant to
Circuit Rule 27(d), Appellants are combining this response with their
reply to Appellees' response to Appellants' November 17, 2000, motion for
injunction pending appeal.
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 9th Report on Carcinogens ("9th
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
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
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 7th 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
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,
In 1998, two years after the
promulgation of the revised criteria, the agency published the 8th
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 8th
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)
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.
Agency's Motion for Summary
Affirmance Should Be Denied.
A. The Agency Fails to
Meet the Standard for
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
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
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 9th 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
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
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
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
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
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
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
There is nothing in this final paragraph indicating any substantive change
in the evidence considered relevant under the criteria for the known
C. The Agency Never Announced
and Provided a
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
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
B. Appellants Satisfy the Standard for
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
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.
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
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
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
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
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
The agency describes
epidemiological evidence as "the strongest evidence for establishing
a relationship" between chemical exposure and carcinogenicity in
humans. E.g., 8th RoC (Exh. 1 to P.I. App. (Dkt. Ref.
20)) at 1. (back
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., 8th RoC (Exh. 1 to P.I. App. (Dkt. Ref.
20)) at 1. (back
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.
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
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
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
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
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'
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
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
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
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)).
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.
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
Even these later
"clarifications" do not notify the public of any substantive
change in the "known" criteria. See Am. Compl. Exhs. 27,
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
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
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