Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-00-05364/USCOURTS-caDC-00-05364-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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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.

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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 carcinogens, the Secretary upgraded the chemical dioxin from the

"reasonably anticipated" to the "known" category. A manufacturer 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 Secretary'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.

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prepared biennially by the Department's National Toxicology

Program ("NTP"). Although HHS does not regulate substances 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) (requiring OSHA-regulated laboratories to adopt special procedures

for substances listed in the Report as known human carcinogens); 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 substances that the agency believes merit consideration. At

about the same time, an NTP committee, the Report on

Carcinogens Review Committee, reviews the scientific literature 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 hearings and receives written comments. Then, the subcommittee and the Working Group make formal recommendations to

the NTP Executive Committee, which in turn makes a recommendation to the NTP Director. After independently evaluating the Executive Committee's recommendation, the DiUSCA Case #00-5364 Document #640338 Filed: 11/23/2001 Page 3 of 18
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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 substances as "known" or "reasonably anticipated to be" human

carcinogens. As originally issued in 1982, the criteria provided:

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 interpretation is credible, but that the alternative explanations, 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 tumors: (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 epidemiological studies were considered when placing a substance in

the first category. Many in the scientific community, however, began to urge revision of the criteria to provide for

broader consideration of "mechanistic" evidence--that is, evidence of the actual biochemical processes by which a substance 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.

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Reasonably Anticipated to be a Human Carcinogen:

There is limited evidence of carcinogenicity from studies in humans, which indicates that causal interpretation 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 multiple species or at multiple tissue sites, or (b) by multiple 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 anticipated to be human carcinogen or there is convincing

relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.

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Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment,

with consideration given to all relevant information. Relevant information includes but is not limited to dose

response, route of exposure, chemical structure, metabolism, 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, unindented 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 commercially 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 inhalation of [dioxin] from municipal, medical, and industrial

waste incinerators and other incineration and combustion

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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 Committee, the proposed listing was forwarded to the Working

Group and the subcommittee of the Board of Scientific Counselors. 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 [dioxin] induces benign and malignant neoplasms at multiple issue [sic] sites in multiple species;

A compelling body of evidence indicates a basic similarity 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 substances 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 emphasized 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 Director approved it. Concurring with the Director, the Secretary listed dioxin in the Ninth Report as a known carcinogen.

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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 epidemiological evidence that it causes cancer in humans. Finding

the Secretary's interpretation of the criteria "eminently reasonable," 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.

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Standing

To have Article III standing, a plaintiff must demonstrate

an "actual or immediate" "injury-in-fact" that is "fairly traceable" 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 resolutions calling for the phasing out of all, or nearly all, PVCcontaining 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 California municipalities--San Francisco, Oakland and Berkeley--

adopted resolutions forcefully calling for healthcare institutions 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, Connecticut, to Charlotte, North Carolina, to Seattle, Washington,

have held hearings on PVC plastic use. See Center for

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Health, Environment and Justice, Dioxin Public Event Update (Nov. 4, 1999). Supporting Brevet's claim that environmental groups are pressuring healthcare providers to reduce

or eliminate the use of PVC plastic, record evidence demonstrates 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 products. 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 reduced 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 quotation 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 traceable 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 independent actions of third parties, we have required only a showing

that "the agency action is at least a substantial factor motivating the third parties' actions." Cmty. for Creative Nonviolence v. Pierce, 814 F.2d 663, 669 (D.C. Cir. 1987). For

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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 independent 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 "substantial factor" in the decisions of state and local agencies to

regulate products containing dioxin or of healthcare companies 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 regulatory authorities. See id. (requiring that the list include "an

evaluation of the efficacy of appropriate existing regulatory

standards, and recommendations regarding the need to improve these standards"). These hopes regarding the list's

importance have been realized. The list is widely disseminated and highly influential: A member of the Board of Scientific 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 Department'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,

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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 companies, 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 "carcinogen" 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

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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 characterizes 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 characterized 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 Department argues that the listing is unreviewable. It points

out that the Report's preamble states that it is "for informational 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."

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Kennecott Utah Copper, 88 F.3d at 1223. Additional considerations, 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 inaccurate: 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 listing'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 repeatedly 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 inclusion 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 Secretary acted arbitrarily and capriciously. See 5 U.S.C.

s 706(2)(A). According to Brevet, the criteria's final paragraph, which permits the use of mechanistic evidence, applies

only to the "reasonably anticipated" category, leaving unaffected the traditional understanding that the Secretary may

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list a substance in the "known" category only if there is

"sufficient" evidence from epidemiological studies. Interpreting 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 construction is the only possible one, or even the one that the

court would have adopted in the first instance." Wyo. Outdoor 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 regulation'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

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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 contradiction. 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 presented an equally plausible alternative construction.").

Brevet next argues that "contemporaneous evidence" indicates 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 Secretary'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" category are substantively unchanged, the newsletter, after quoting 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 paragraph applies to the "known" category as well.

The decision of the district court is affirmed.

So ordered.

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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 practice 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 definition, but no less an administrative law authority than Justice

Scalia once wrote:

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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 interpretation 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. Perhaps 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 purpose 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 substances qualify as known carcinogens, which is why I think it

is properly described as an interpretive rule.

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