Court Opinion

ID: 185520
Source: CourtListenerOpinion
Date Created: 2011-02-05 02:33:01+00
Date Added: 2024-06-11T12:37:03.638093
License: Public Domain

271 F.3d 301 (D.C. Cir. 2001)
Jim J. Tozzi in his personal capacity, and as President of Multinational Business Services, Inc., et al., Appellantsv.U. S. Department of Health and Human Services, et al., Appellees
No. 00-5364
United States Court of Appeals  FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued September 17, 2001Decided November 23, 2001

[Copyrighted Material Omitted]
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:

1
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  knownhuman 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.

2
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  § 262, 92 Stat. 3412, 3435-36 (1978) (amending 42 U.S.C.  § 241).  Entitled the Report on Carcinogens, the list is  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.  § 1910.1200(d)(4)(i).  See also id. § 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. § 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).

3
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 Director 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).

4
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:

5
There is sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship between the agent and human cancer.

6
Reasonably Anticipated to be a Human Carcinogen:

7
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

8
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.

9
Eighth Report.

10
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:

11
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.

12
Reasonably Anticipated to be a Human Carcinogen:

13
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

14
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.

15
Conclusions regarding carcinogenicity in humans or experimental animalsare 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.

16
Eighth Report.

17
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).

18
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.

19
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:

20
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  processes ... and ingestion of drinking water (0.01% of the daily intake).

21
Id.  Most people have some level of dioxin in their tissues. Id.

22
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:

23
[Dioxin] is known to be a human carcinogen based on several types of evidence:

24
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;

25
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.

26
Draft RC Background Document (Sept. 30, 1997).

27
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.

28
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.

29
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

30
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.

31
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 issueand 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.

32
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 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....").

33
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.

34
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  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 purchasingdecisions 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).

35
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, 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.

36
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).

37
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.

38
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

39
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).

40
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." Kennecott Utah Copper, 88 F.3d at 1223.  Additional considerations, however, lead us to conclude otherwise.

41
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 304.  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 34.

42
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. § 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.

43
Having found that Brevet has standing and that the listing  is reviewable, we turn to the merits.

III.

44
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.  § 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 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 305-06, shows the last paragraph with wider margins than the  preceding paragraphs.

45
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.

46
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 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.").

47
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.

48
The decision of the district court is affirmed.

49
So ordered.

Notes:

*
  Senior Circuit Judge Williams was in regular active service at  the time of oral argument.

50
Silberman, Senior Circuit Judge, concurring:

51
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 § 551(4).

52
"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;  ....

53
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.

54
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:

55
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.

56
Scalia, Vermont Yankee:  The APA, the D.C. Circuit, and the  Supreme Court, 1978 Sup. Ct. Rev. 345, 383.

57
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.