Tozzi v. U. S. Dept. of Health & Human Serv.

• Decision Date: 23 November 2001
• Docket Number: No. 00-5364,00-5364
• Citation: 271 F.3d 301
• Parties: (D.C. Cir. 2001) 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
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 301

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., Appellants v. 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, 2001

Decided 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:

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 § 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).

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).

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.

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.

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...