United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 17, 2001 Decided November 23, 2001
No. 00-5364
Jim J. Tozzi in his personal capacity, and as
President of Multinational Business Services, Inc., et al.,
Appellants
v.
U. S. Department of Health and Human Services, et al.,
Appellees
Appeal from the United States District Court
for the District of Columbia
(No. 99cv01170)
Charles J. Fromm argued the cause and filed the briefs for
appellants.
Terry F. Quill was on the brief for amici curiae Public
Health Scientists in support of appellants.
Peter D. Blumberg, Assistant U.S. Attorney, argued the
cause for appellee. With him on the brief were Kenneth L.
Wainstein, U.S. Attorney, and R. Craig Lawrence, Assistant
U.S. Attorney.
Before: Tatel, Circuit Judge, Silberman and Williams*,
Senior Circuit Judges.
Opinion for the Court filed by Circuit Judge Tatel.
Concurring opinion filed by Senior Circuit Judge
Silberman.
Tatel, Circuit Judge: Acting pursuant to a provision of the
Public Health Service Act that requires the Secretary of
Health and Human Services to publish a list of substances
"known" or "reasonably anticipated to be" human carcino-
gens, the Secretary upgraded the chemical dioxin from the
"reasonably anticipated" to the "known" category. A manu-
facturer of products that release dioxin when incinerated,
together with others allegedly affected by the upgrade, argue
that the Secretary, in violation of HHS regulations, acted
without sufficient epidemiological evidence that dioxin is a
known human carcinogen. Although we reject the Secre-
tary's arguments that the manufacturer lacks standing and
that the upgrade decision is unreviewable, we agree with the
district court that, given the deference owed an agency's
interpretation of its own regulations, the Secretary acted
neither arbitrarily nor capriciously.
I.
In 1978, Congress amended the Public Health Service Act
to require the Secretary of Health, Education and Welfare,
now Health and Human Services, to publish a list of known
and suspected carcinogens. See Biomedical Research and
Research Training Amendments, Pub. L. No. 95-622, Tit. II
s 262, 92 Stat. 3412, 3435-36 (1978) (amending 42 U.S.C.
s 241). Entitled the Report on Carcinogens, the list is
__________
* Senior Circuit Judge Williams was in regular active service at
the time of oral argument.
prepared biennially by the Department's National Toxicology
Program ("NTP"). Although HHS does not regulate sub-
stances based upon their inclusion in the Report, a listing--or
in some instances an upgrade--may trigger obligations under
other agency regulations. For example, OSHA's Hazard
Communication Standard requires manufacturers to label as
a carcinogen every substance listed in the Report. 29 C.F.R.
s 1910.1200(d)(4)(i). See also id. s 1910.1450(e)(viii) (requir-
ing OSHA-regulated laboratories to adopt special procedures
for substances listed in the Report as known human carcino-
gens); 30 C.F.R. s 47.11 (defining some hazardous chemicals
in part by reference to the Report and requiring Department
of Labor-regulated mine operators to identify hazardous
chemicals produced or brought on to mine property). A
listing can also trigger obligations under state regulations.
See Synthetic Organic Chem. Mfrs. Ass'n v. Sec'y, Dep't
Health and Human Servs., 720 F. Supp. 1244, 1248 (W.D.
Louisiana 1989) (listing triggered state regulatory provisions).
Before the Secretary may list (or delist) a substance, the
substance undergoes a multi-step review process. See HHS
Eighth Report on Carcinogens (1998), app. C. Acting on
recommendations from the scientific community, the NTP
begins by publishing in the Federal Register a list of sub-
stances that the agency believes merit consideration. At
about the same time, an NTP committee, the Report on
Carcinogens Review Committee, reviews the scientific litera-
ture and prepares a background document discussing the
literature and recommending substances for listing. These
recommendations, together with the background document
and any public comments received in response to the Federal
Register notice, are sent to two peer review committees: the
NTP's Interagency Working Group (a committee composed of
scientists from several federal agencies) and a subcommittee
of the NTP's Board of Scientific Counselors (a chartered
advisory committee). The subcommittee holds public hear-
ings and receives written comments. Then, the subcommit-
tee and the Working Group make formal recommendations to
the NTP Executive Committee, which in turn makes a recom-
mendation to the NTP Director. After independently evalu-
ating the Executive Committee's recommendation, the Di-
rector submits a final draft of the Report to the Secretary. If
the Secretary approves the Report, a notice is published in
the Federal Register identifying all newly listed (or delisted)
substances, classifying them as either "known" or "reasonably
anticipated to be" human carcinogens, and announcing the
availability of the latest Report. Of significance to this case,
the Secretary may not move substances from one category to
the other without going through the same formal review
process. See Eighth Report (describing multi-step review
process).
The Secretary has issued "criteria" for classifying sub-
stances as "known" or "reasonably anticipated to be" human
carcinogens. As originally issued in 1982, the criteria provid-
ed:
Known to be Carcinogens:
There is sufficient evidence of carcinogenicity from
studies in humans which indicates a causal relationship
between the agent and human cancer.
Reasonably Anticipated to be a Human Carcinogen:
A. There is limited evidence of carcinogenicity from
studies in humans, which indicates that casual inter-
pretation is credible, but that the alternative explana-
tions, such as chance, bias or confounding, could not
adequately be excluded, or
B. There is sufficient evidence of carcinogenicity
from studies in experimental animals which indicates
that there is an increased incidence of malignant tu-
mors: (a) in multiple species or strains, or (b) in
multiple experiments (preferably with different routes
of administration or using different dose levels), or (c)
to an unusual degree with regard to incidence, site or
type of tumor, or age at onset. Additional evidence
may be provided by data concerning dose-response
effects, as well as information on mutagenicity or
chemical structure.
Eighth Report.
The parties agree that under these criteria only epidemio-
logical studies were considered when placing a substance in
the first category. Many in the scientific community, howev-
er, began to urge revision of the criteria to provide for
broader consideration of "mechanistic" evidence--that is, evi-
dence of the actual biochemical processes by which a sub-
stance causes cancer. In response, the Secretary published
revised criteria in 1996. Because the differences between
these criteria and the 1982 version are central to this case, we
quote the new version in full:
Known to be a Human Carcinogen:
There is sufficient evidence of carcinogenicity from
studies in humans which indicates a causal relationship
between exposure to the agent, substance or mixture
and human cancer.
Reasonably Anticipated to be a Human Carcinogen:
There is limited evidence of carcinogenicity from stud-
ies in humans, which indicates that causal interpreta-
tion is credible, but that alternative explanations, such
as chance, bias or confounding, could not adequately be
excluded; or
There is sufficient evidence of carcinogenicity from
studies in experimental animals which indicates that
there is an increased incidence of malignant and/or
combined benign and malignant tumors: (a) in multi-
ple species or at multiple tissue sites, or (b) by multi-
ple routes of exposure, or (c) to an unusual degree with
regard to incidence, site or type of tumor, or age at
onset; or
There is less than sufficient evidence of carcinogenicity
in humans or laboratory animals; however, the agent
belongs to a well defined structurally-related class of
substances whose members are listed in a previous
Annual or Biennial Report on Carcinogens as either
known to be human carcinogen, or reasonably antici-
pated to be human carcinogen or there is convincing
relevant information that the agent acts through mech-
anisms indicating it would likely cause cancer in hu-
mans.
Conclusions regarding carcinogenicity in humans or ex-
perimental animals are based on scientific judgment,
with consideration given to all relevant information. Rel-
evant information includes but is not limited to dose
response, route of exposure, chemical structure, metabo-
lism, pharmacokinetics, sensitive sub populations, genetic
effects, or other data relating to mechanism of action or
factors that may be unique to a given substance. For
example, there may be substances for which there is
evidence of carcinogenicity in laboratory animals but
there are compelling data indicating that the agent acts
through mechanisms which do not operate in humans and
would therefore not reasonably be anticipated to cause
cancer in humans.
Eighth Report.
The precise question before us is whether the final, unindent-
ed paragraph modifies both categories (as the Secretary
interprets it) or only the "reasonably anticipated" category
(as appellants claim).
This case involves the Secretary's decision to upgrade
dioxin from the "reasonably anticipated" to the "known"
category. A colorless, needle-shaped chemical not commer-
cially produced, dioxin is released as a by-product of paper
and pulp bleaching. See HHS Ninth Report on Carcinogens,
Addendum (2001). Dioxin is also emitted during incineration
of chlorine-containing materials, such as polyvinyl chloride
("PVC") plastic. Incineration of hospital waste, which usually
contains PVC plastic, produces large quantities of dioxin. Id.
Chemically stable, dioxin persists in the environment for
long periods of time. Because dioxin settles into soil and
water, it ends up in animal fatty tissue and eventually meat
and dairy products. According to the Ninth Report, human
exposure occurs in several ways:
Food is the major source (>90%) of human exposure to
[dioxin] ... Other pathways of exposure include inhala-
tion of [dioxin] from municipal, medical, and industrial
waste incinerators and other incineration and combustion
processes ... and ingestion of drinking water (0.01% of
the daily intake).
Id. Most people have some level of dioxin in their tissues.
Id.
The Secretary originally listed dioxin in the "reasonably
anticipated" category. See Ninth Report supra. In 1997,
however, the International Agency for Research on Cancer
("IARC"), a division of the World Health Organization that
has its own carcinogen classification scheme, upgraded dioxin
to its highest category based on "limited" epidemiological
evidence and "strong" evidence that dioxin acts "through a
relevant mechanism of carcinogenicity." Id. In response,
the NTP proposed upgrading dioxin to the "known" category.
After approval by the Report on Carcinogens Review Com-
mittee, the proposed listing was forwarded to the Working
Group and the subcommittee of the Board of Scientific Coun-
selors. The Working Group approved the upgrade, and after
notice and public comment, so did the Board. The draft
background document relied on both epidemiological and
mechanistic evidence:
[Dioxin] is known to be a human carcinogen based on
several types of evidence:
Human studies have found an association between
dioxin exposure and cancer mortality with respect to
all cancers combined, non-Hodgkin's lymphoma, and
lung cancer;
Studies in experimental animals have shown that [diox-
in] induces benign and malignant neoplasms at multi-
ple issue [sic] sites in multiple species;
A compelling body of evidence indicates a basic simi-
larity in the mechanism of induction of animal and
human tissue biochemical and toxicological responses
to [dioxin] at comparable doses and tissue levels.
Draft RC Background Document (Sept. 30, 1997).
Following the Board's approval, Jim Tozzi, a "regulatory
consultant" and an appellant in this case, sent a letter to the
NTP Director stating that the Secretary may not list sub-
stances in the known category without "sufficient" evidence
from epidemiological studies. Tozzi also complained that
"[t]oo much was crammed into too little time" and that the
NTP failed to provide certain "key" documents to the public.
Responding to Tozzi's letter and conceding that "review had
been inadequate," the NTP Director announced a "re-review"
of dioxin "includ[ing] another open, public review by the NTP
Board Subcommittee." At the same time, the Director em-
phasized his belief that "the criteria [had been] appropriately
applied." After the additional round of notice and comment,
the Board of Scientific Counselors voted against the upgrade,
but both the NTP Executive Committee and the NTP Di-
rector approved it. Concurring with the Director, the Secre-
tary listed dioxin in the Ninth Report as a known carcinogen.
Tozzi, together with Brevet Industries, a manufacturer of
disposable plastic connectors used during open heart surgery,
the Empire State Restaurant & Tavern Association, and
Greenbaum & Gilhooleys, a New York restaurant, then filed
suit in the United States District Court for the District of
Columbia pursuant to the Administrative Procedure Act, 5
U.S.C. 702-706, claiming that the Secretary acted arbitrarily
and capriciously by upgrading dioxin without sufficient epide-
miological evidence that it causes cancer in humans. Finding
the Secretary's interpretation of the criteria "eminently rea-
sonable," the district court granted summary judgment for
the Department. See Tozzi v. United States Dep't of Health
and Human Servs., No. 99-1170 (D.D.C. Sept. 30, 2000).
Tozzi, Brevet, and the culinary plaintiffs now appeal. Our
review is de novo. Russell v. Principi, 257 F.3d 815, 818
(D.C. Cir. 2001)
II.
We begin with two threshold issues. The Department
argues that none of the appellants has standing to challenge
the dioxin upgrade and that, in any case, listing decisions are
unreviewable. We consider each argument in turn.
Standing
To have Article III standing, a plaintiff must demonstrate
an "actual or immediate" "injury-in-fact" that is "fairly trace-
able" to the challenged conduct and "likely" to be "redressed
by a favorable decision." Lujan v. Defenders of Wildlife, 504
U.S. 555, 560-61 (1992) (internal quotations marks omitted).
The plaintiff's allegations must not be purely "speculative--
the ultimate label for injuries too implausible to support
standing." Advanced Mgmt. Tech., Inc. v. FAA, 211 F.3d
633, 637 (D.C. Cir. 2000) (internal quotation marks omitted).
Applying this standard, the district court found that Brevet
had standing.
The Department first argues that Brevet has failed to show
actual or immediate injury. We disagree. According to an
affidavit submitted by Brevet's president, over ninety-five
percent of the company's sales depend on the continued use
of PVC plastic by the medical establishment. Brewer Aff.
p 10. The president also states that healthcare companies,
pressured by environmental groups, have expressed concern
over the dioxin hazards associated with incineration of PVC
medical supplies; that some municipalities have adopted reso-
lutions calling for the phasing out of all, or nearly all, PVC-
containing products, including medical supplies; and that
Brevet's "profits, reputation and goodwill" would be adversely
affected if an "authoritative U.S. government agency issue[d]
and widely disseminate[d] a report implying ... that Brevet's
products are responsible for introducing a known human
carcinogen into the environment." Id. p p 6-9.
Record evidence supports Brevet's claims. Three Califor-
nia municipalities--San Francisco, Oakland and Berkeley--
adopted resolutions forcefully calling for healthcare institu-
tions to eliminate their use of PVC plastic. See City and
County of San Francisco Resolution No. 021-98-COE (Sept.
8, 1998); Oakland City Council Resolution No. 74778 (Feb. 2,
1999); Berkeley Resolution No. 60, 196-N.S. (Sept. 14, 1999).
Elsewhere, state and local agencies from Hartford, Connecti-
cut, to Charlotte, North Carolina, to Seattle, Washington,
have held hearings on PVC plastic use. See Center for
Health, Environment and Justice, Dioxin Public Event Up-
date (Nov. 4, 1999). Supporting Brevet's claim that environ-
mental groups are pressuring healthcare providers to reduce
or eliminate the use of PVC plastic, record evidence demon-
strates that Tenet Healthcare Corporation, which annually
purchases over three billion dollars worth of medical supplies,
has announced that it will seek to purchase PVC-free prod-
ucts. See Press Release, Healthcare Without Harm, Tenet
Prefers Non-PVC Medical Products (Oct. 6, 1999) Other
Brevet customers (actual and potential) including Baxter
International, Universal Health Services, Kaiser Permanente
and Catholic Healthcare West have announced similar moves.
Id. We thus think it not at all "speculative," Advanced
Mgmt., 211 F.3d at 637, to expect that Brevet, a company
whose revenues depend almost entirely on the continued use
of PVC plastic in the medical industry, will experience re-
duced profits. See DIRECTV, Inc. v. FCC, 110 F.3d 816, 829
(D.C. Cir. 1997) ("[S]tanding ... may be established by
reference ... to lost profits....").
The Department next argues that even if Brevet's profits
were to decline, that injury would not be "fairly traceable" to
the dioxin upgrade. Lujan, 504 U.S. at 590 (internal quota-
tion marks omitted). The Department points out that the
anti-dioxin movement predates the listing process. It also
claims that pressure on government agencies to regulate
dioxin and on healthcare companies to reduce the use of PVC
products will continue whether or not dioxin remains listed as
a known human carcinogen.
Even if the Department's claims were true, we disagree
that Brevet has failed to show that its injury is fairly tracea-
ble to the dioxin upgrade. As we pointed out in Block v.
Meese, we have never applied a "tort" standard of causation
to the question of traceability. 793 F.2d 1303, 1309 (D.C. Cir.
1986). Where, as here, the alleged injury flows not directly
from the challenged agency action, but rather from indepen-
dent actions of third parties, we have required only a showing
that "the agency action is at least a substantial factor motivat-
ing the third parties' actions." Cmty. for Creative Non-
violence v. Pierce, 814 F.2d 663, 669 (D.C. Cir. 1987). For
example, we have allowed plaintiffs claiming that regulatory
changes have caused "competitive injury," defined only as
"exposure to competition," to sue the regulating agencies,
even though the harm resulted most directly from indepen-
dent purchasing decisions of third parties. Bristol-Myers
Squibb Co. v. Shalala, 91 F.3d 1493, 1499 (D.C. Cir. 1996);
Liquid Carbonic Indus. Corp. v. FERC, 29 F.3d 697, 701
(D.C. Cir. 1994) (citing cases).
Applying this standard to the facts of this case, we have
little doubt that the dioxin upgrade will represent a "substan-
tial factor" in the decisions of state and local agencies to
regulate products containing dioxin or of healthcare compa-
nies to reduce or end purchases of PVC plastics. Congress
intended the Report on Carcinogens to serve as the federal
government's authoritative statement on the current state of
knowledge regarding the carcinogenicity of various chemicals.
See H. R. Rep. No. 95-1192, at 28 (1978) (referring to the list
as a "comprehensive document" containing "all known or
suspected carcinogenic agents"). Congress also intended the
list to serve as a resource for state, federal and local regulato-
ry authorities. See id. (requiring that the list include "an
evaluation of the efficacy of appropriate existing regulatory
standards, and recommendations regarding the need to im-
prove these standards"). These hopes regarding the list's
importance have been realized. The list is widely disseminat-
ed and highly influential: A member of the Board of Scienti-
fic Counselors noted that "the Report on Carcinogens ... is a
very important document.... It is used ... by a number of
regulatory groups both nationally as well as internationally
and I think it has a very large impact on preventing possible
hazards to the U.S. public...." Tr. Proceedings, Board of
Scientific Counselors, Report on Carcinogens Subcommittee
Meeting at 10 (Oct. 30, 1997). Thus, contrary to the Depart-
ment's argument, we think it not at all "speculative" to expect
that the dioxin upgrade will cause some non-trivial number of
state and local agencies to regulate dioxin. Indeed, the
Berkeley, Oakland, and San Francisco resolutions all cite the
initial Review Committee's preliminary determination for the
proposition that dioxin is "known" to be a human carcinogen,
not merely hypothesized to be carcinogenic. See Resolutions,
supra at 9. Because of the Report's importance, moreover,
we have no doubt that the Secretary's decision to upgrade
dioxin will cause some non-trivial number of healthcare com-
panies, already under pressure from environmental activists,
to reduce or end their use of PVC plastics.
An additional factor reinforces our conclusions regarding
both injury and causation: When the government attaches an
inherently pejorative and damaging term such as "carcino-
gen" to a product, the probability of economic harm increases
exponentially. The Department's reliance on Block, in which
the government's label of "propaganda" was not inherently
pejorative, is therefore misplaced. It is not too speculative to
conclude that the Report will injure Brevet economically,
even with the presence of other causal factors. See, e.g.,
Mountain States Legal Found. v. Glickman, 92 F.3d 1228,
1234-35 (D.C. Cir. 1996) (holding incremental risk of forest
fires from Forest Service's challenged decision sufficient to
support Article III standing, despite existence of other causal
factors for forest fires).
Equally without merit is the Department's contention that
even assuming a likely injury fairly traceable to the dioxin
upgrade, Brevet's injury is not "redressable." Lujan, 504
U.S. at 561. While it may be true, as the Department insists,
that municipalities and healthcare providers will not reverse
decisions to limit PVC use, we do not agree that "Brevet's
alleged future harm could not be redressed by a decision of
this Court." Appellee's Br. at 19. Nothing in the record
indicates that any other federal agency has labeled dioxin a
"known" carcinogen and, asked about this at oral argument,
counsel for the Department was unable to name one either.
Thus, were we to set aside the Secretary's upgrade decision,
dioxin activists could no longer point to an authoritative
determination by the United States government that dioxin is
"known" to cause cancer in humans. Conversely, Brevet
could point out that a government report widely accepted as
comprehensive no longer lists dioxin as a "known" carcinogen.
State and local governments would be less likely to regulate
dioxin, and healthcare companies would in turn be less likely
to stop using PVC plastic. In short, reclassifying dioxin
would redress at least some of Brevet's economic injury.
Because Brevet has Article III standing, we need not
consider whether the culinary appellants and Tozzi have
standing as well. See Watt v. Energy Action Educ. Found.,
454 U.S. 151, 160 (1981) (declining to address standing of
remaining plaintiffs after finding one plaintiff with standing);
Mountain States, 92 F.3d at 1232 (same).
Reviewability
Reviewability under the APA hinges upon whether the
listing has "legal effect, which in turn is a function of the
agency's intention to bind either itself or regulated parties."
Kennecott Utah Copper Corp. v. United States Dep't of
Interior, 88 F.3d 1191, 1223 (D.C. Cir. 1996). In making this
determination, we have sometimes looked to "the agency's
own characterization of its action" and to "publication or the
lack thereof in the Federal Register or the Code of Federal
Regulations." Am. Portland Cement Alliance v. EPA, 101
F.3d 772, 776 (D.C. Cir. 1996). Where the agency character-
izes its action as non-binding or does not publish in the
Federal Register, we have found the action unreviewable.
See, e.g., id. (finding agency's "regulatory determinations"
unreviewable because not published and not characterized as
binding); Telecomms. Research & Action Ctr. v. FCC, 800
F.2d 1181, 1186 (D.C. Cir. 1986) (finding document to be
merely general policy statement in part because agency char-
acterized it as produced "solely for the purpose of reference
and convenience") (internal quotation marks and citation
omitted).
Seizing upon these two indicia of unreviewability, the De-
partment argues that the listing is unreviewable. It points
out that the Report's preamble states that it is "for informa-
tional purposes only" and that the Secretary never published
the entire report in the Federal Register. Taken alone, the
characterization of the Report as informational might well
support a conclusion that the Report has no "legal effect."
Kennecott Utah Copper, 88 F.3d at 1223. Additional consid-
erations, however, lead us to conclude otherwise.
To begin with, although the final Report was not published
in the Federal Register, the Secretary did publish a notice
proposing a dioxin upgrade and, once finalized, a summary of
the decision. Equally important, even though the Secretary
takes no action pursuant to a listing, the contention that a
listing has no "binding effect," Appellee's Br. at 25, is inaccu-
rate: Listing a substance as a human carcinogen triggers
obligations under OSHA, Department of Labor and state
regulations. See supra at 3. Additional evidence of a list-
ing's "legal effect" comes from the fact that in order to
remove a substance from either category, the Secretary must
undertake the same elaborate procedure--including notice
and comment--required for an initial listing. See supra at 3-
4.
Nothing in Industrial Safety Equipment Association v.
EPA, 837 F.2d 1115 (D.C. Cir. 1988), requires a different
result. In that case, we found unreviewable an agency guide
that ranked respirators, emphasizing that the guide repeated-
ly noted that it was not discussing a "regimen presently
mandated by law." Id. at 1120. By contrast, the carcinogen
classification scheme is mandated by the Public Health Act.
See 42 U.S.C. s 241(b)(4)(A). Moreover, the respirator guide
was never published in the Federal Register, nor did inclu-
sion of respirators in the guide trigger other regulatory
obligations. Indus. Safety, 837 F.2d at 1121.
Having found that Brevet has standing and that the listing
is reviewable, we turn to the merits.
III.
Brevet argues that by upgrading dioxin on the basis of
mechanistic rather than epidemiological evidence, the Secre-
tary acted arbitrarily and capriciously. See 5 U.S.C.
s 706(2)(A). According to Brevet, the criteria's final para-
graph, which permits the use of mechanistic evidence, applies
only to the "reasonably anticipated" category, leaving unaf-
fected the traditional understanding that the Secretary may
list a substance in the "known" category only if there is
"sufficient" evidence from epidemiological studies. Interpret-
ing the criteria differently, the Department insists that the
last paragraph applies to both categories, thus permitting
reliance on mechanistic evidence when classifying substances
as known carcinogens. In support of this interpretation, the
Department points out that the version appearing in the
published Report, quoted in full earlier in this opinion, supra
at 5-6, shows the last paragraph with wider margins than the
preceding paragraphs.
Because Brevet challenges the Secretary's interpretation of
an HHS regulation (Brevet nowhere argues that the criteria
are not a regulation), we owe the Secretary "substantial
deference." Thomas Jefferson Univ. v. Shalala, 512 U.S.
504, 512 (1994). We "need not find that the agency's con-
struction is the only possible one, or even the one that the
court would have adopted in the first instance." Wyo. Out-
door Council v. United States Forest Serv., 165 F.3d 43, 52
(D.C. Cir. 1999). Indeed, we give the agency's interpretation
"controlling weight," Bowles v. Seminole Rock & Sand Co.,
325 U.S. 410, 414 (1945), unless an "alternative reading is
compelled by the regulation's plain language or by other
indications of the Secretary's intent at the time of the regula-
tion's promulgation." Consolidation Coal Co. v. Fed. Mine
Safety and Health Review Comm'n, 136 F.3d 819, 822 (D.C.
Cir. 1998) (internal quotation marks and citation omitted).
Brevet falls far short of meeting this highly deferential
standard.
For one thing, not only does the absence of indentation
support the Secretary's interpretation, but Brevet points to
no textual evidence demonstrating that the last paragraph
applies only to the "reasonably anticipated" category. Brevet
argues that the Secretary's interpretation completely defeats
language in the "known" category, which the company says
requires "studies in humans" (meaning, according to Brevet,
exclusively epidemiology) that are "sufficient" to "indicate[ ] a
causal relationship" between the substance and cancer.
Thus, Brevet says, a substance that fails that test cannot be
classified as such. At most, however, Brevet has shown an
inconsistency between the criteria's formatting (the absence
of indentation) and the "known" category's text, in which case
we would defer to the Secretary's resolution of the contra-
diction. See Cold Spring Granite Co. v. Fed. Mine Safety
and Health Review Comm'n, 98 F.3d 1376, 1378 (D.C. Cir.
1996) ("The Secretary's plausible and sensible reading of his
own regulation would prevail even if the company had pre-
sented an equally plausible alternative construction.").
Brevet next argues that "contemporaneous evidence" indi-
cates that the Secretary had no intention of broadening the
"known" criteria through the 1996 revisions. Appellants'
Opening Br. at 23-27. In support of this argument, Brevet
points to a press release issued by the Secretary's Office on
the day the revised criteria were published and to an article
in Environmental Health Perspectives, the NTP's official
newsletter, both of which state that the criteria for listing in
the "known" category remain "unchanged." We see nothing
in either document demonstrating that the interpretation the
Department offers here "marks a departure from [the Secre-
tary's] stated prior understanding in enacting the regulation."
Consolidation Coal, 136 F.3d at 822. Although portions of
the press release quote the Secretary, the statement that the
criteria for the "known" category remain unchanged was not
a quotation, nor does anything in the record indicate that the
Secretary or any official with authority to interpret the
criteria authorized the statement. In addition to suffering
from the same defect, the newsletter is at best ambiguous.
Although saying that the 1996 criteria for the "known" cate-
gory are substantively unchanged, the newsletter, after quot-
ing the criteria's final paragraph in full, states that "the last
factor is especially important 'for the reasonably anticipated
to be a human carcinogen category' " [emphasis added]. The
phrase "especially important" suggests that the final para-
graph applies to the "known" category as well.
The decision of the district court is affirmed.
So ordered.
Silberman, Senior Circuit Judge, concurring: I concur
with all parts of the court's opinion including the portion
dealing with reviewability. But it is an interesting question
how one should categorize the agency's action that we review.
It might be thought to be an informal adjudication--a specific
application of the regulation--but because it has only a future
effect, I think it is accurately described as an interpretive
rule. It certainly has more bite than the typical policy
statement, many of which are not reviewable at all. See, e.g.,
Kennecott Utah Copper v. United States Dep't of Interior, 88
F.3d 1191, 1223 (D.C. Cir. 1996). In that regard, I should
like to express a view on the question raised by the panel in
Appalachian Power Co. v. EPA, 208 F.3d 1015, 1021-22 (D.C.
Cir. 2000). In that case the panel, recognizing our split of
authority, suggested that virtually all agency statements of
future effect--including policy statements--were rules under
the broad definitional language of s 551(4).
"rule" means the whole or a part of an agency statement
of general or particular applicability and future effect
designed to implement, interpret, or prescribe law or
policy or describing the organization, procedure, or prac-
tice requirements of an agency and includes the approval
or prescription for the future of rates, wages, corporate
or financial structures or reorganization thereof, prices,
facilities, appliances, services or allowances therefor or of
valuations, costs, or accounting, or practices bearing on
any of the foregoing; ....
The panel said "virtually all," but in light of its suggested
disagreement with Syncor International Corp. v. Shalala, 127
F.3d 90, 94 (D.C. Cir. 1997), which described a typical policy
statement as only an indication of an agency's enforcement
policy, I cannot imagine what the panel meant to exclude-or
given its reasoning what could be excluded.
The panel criticized Syncor and our prior opinions on which
Syncor relied for not considering explicitly the APA defini-
tion, but no less an administrative law authority than Justice
Scalia once wrote:
Since every statement is of either general or particular
applicability, and since everything an agency does is
"designed to implement, interpret, or prescribe law or
policy, etc." the only limiting (that is to say, defining)
part of the definition is "agency statement of ... future
effect." This is of course absurd. ... [Therefore] it is
generally acknowledged that the only responsible judicial
attitude toward this central APA definition is one of
benign disregard.
Scalia, Vermont Yankee: The APA, the D.C. Circuit, and the
Supreme Court, 1978 Sup. Ct. Rev. 345, 383.
I agree with then-Professor Scalia that the panel's inter-
pretation is not a reasonable reading ("absurd" might be too
strong). Not every utterance, not every speech (with only
future effect) legitimately can be described as a rule. Per-
haps the key to the definition is the word "prescribed," which
in Random House College Dictionary, means "to lay down a
rule" (emphasis added), and in the 1941 Webster's New
International Dictionary meant "to lay down authoritatively
as a guide" (emphasis added). In other words, Congress
surely meant that an agency statement that serves the pur-
pose of a rule is a rule. If it walks like a rule, and quacks like
a rule--i.e., is laid down--it is a rule. But any agency
statement which does not seek to authoritatively answer an
underlying policy or legal issue does not fit that criteria. In
this case, the agency authoritatively proclaims which sub-
stances qualify as known carcinogens, which is why I think it
is properly described as an interpretive rule.