Synthetic Organic Chem. Mfrs. v. SECRETARY, DHHS, Civ. A. No. 89-0884-LC.

• Decision Date: 28 August 1989
• Docket Number: Civ. A. No. 89-0884-LC.
• Citation: 720 F. Supp. 1244
• Parties: SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS ASSOCIATION, et al. v. SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.
• Court: U.S. District Court — Western District of Louisiana

720 F. Supp. 1244

SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS ASSOCIATION, et al. v. SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.

Civ. A. No. 89-0884-LC.

United States District Court, W.D. Louisiana, Lake Charles Division.

August 28, 1989.

COPYRIGHT MATERIAL OMITTED

Bernard H. McLaughlin, Jr., Stockwell, Sievert, Viccellio, Clements and Shaddock, Lake Charles, La., R. Bruce Dickson, Bruce D. Ryan, Lorie J. Schmidt-Praul, Paul, Hastings, Janofsky & Walker, Washington, D.C., for plaintiffs.

Stuart E. Schiffer, Acting Asst. Atty. Gen., Joseph S. Cage, Jr., U.S. Atty., Thomas B. Thompson, Asst. U.S. Atty., Sheila Lieber and Wendy Kloner, Attys., Dept. of Justice, Civ. Div., Federal Programs Branch, Washington, D.C., for defendants.

Charles S. McCowan, Jr., Bradley C. Myers, Kean, Miller, Hawthorne, D'Armond, McCowan & Jarman, Baton Rouge, La., David J. Hayes, Douglas B. Farquhar, Catherine J. LaCroix, Hogan & Hartson, David F. Zoll, Susan T. Conti, Chemical Mfrs Assn., Washington, D.C., for intervenors Chemical Mfrs. Assn.

Ulysses Gene Thibodeaux, Newman & Thibodeaux, Lake Charles, La., Jacqueline M. Warren, Donald S. Strait, Natural Resources Defense Council, New York City, for Natural Resources Defense Council.

Karen Florini, Environmental Defense Fund, Washington, D.C., for Environmental Defense Fund.

VERON, District Judge.

RULING

This is an action for declaratory judgment and injunctive relief challenging (a) the action of the Department of Health and Human Services ("HHS") establishing procedures and criteria under which the Secretary of Health and Human Services ("Secretary") and the National Toxicology Program ("NTP"), pursuant to 42 U.S.C. § 241(b)(4), classify chemical substances as ones that are known, or that may reasonably be anticipated to be, carcinogens (hereinafter referred to as "Classification Procedures and Criteria") and (b) the application of these Classification Procedures and Criteria to plaintiffs' products (paradichlorobenzene (PDCB), methylene chloride, tetracholroethylene, ethyl acrylate, and chlorinated paraffin) to classify PDCB as a carcinogen.¹ The issues presently before the Court are plaintiff's motion for a preliminary injunction and defendant's motion to dismiss.

This action was originally brought by Synthetic Organic Chemical Manufacturers Association ("SOCMA"), Chlorobenzene Producers Association ("CPA"), PPG Industries, Inc., Lagasse Brothers, Inc. and Standard Chlorine Chemical Company. Plaintiff SOCMA is a non-profit trade association whose members manufacture chemical substances which are affected by the Classification Procedures and Criteria. Plaintiff CPA is an association of all United States producers of chlorobenzenes, including PDCB. The individual corporate plaintiffs manufacture and sell chemicals, including PDCB, a chemical widely used for the control of moths and odor and as an industrial intermediate.

The Chemical Manufacturers Association (CMA) was subsequently granted leave to intervene as a plaintiff. CMA is a nonprofit trade association whose 171 member companies represent over 90% of the productive capacity of basic industrial chemicals in the United States.

The action was originally brought against the Secretary of HHS, the Undersecretary of HHS ("Undersecretary"), the Director of the National Toxicology Program of the National Institute of Health ("NIH") and HHS. The Secretary is the official responsible under 42 U.S.C. § 241(b)(4) for classifying chemical substances as known or reasonably anticipated to be carcinogens to which a significant number of persons are exposed and for publishing his determinations in the Annual Report on Carcinogens ("Annual Report"), 42 U.S.C. § 241(b)(4). The Undersecretary is the official within HHS to whom the Secretary has delegated the responsibility for approving the procedures and criteria under which the Secretary takes the actions required of him by 42 U.S.C. § 241(b)(4). The Director of the National Toxicology Program is the official in HHS to whom the Secretary has delegated responsibility for classifying substances as carcinogens and for preparation of the Annual Report.

The Natural Resources Defense Council ("NRDC") and the Environmental Defense Fund ("EDF") were granted leave to intervene as defendants. NRDC and EDF are national, non-profit membership organizations dedicated to the protection of public health and the environment.

JURISDICTION AND VENUE

This Court has jurisdiction under 28 U.S.C. § 1331 (federal question); 28 U.S.C. § 1337 (Commerce); 28 U.S.C. §§ 2201 and 2202 (Declaratory Judgment Act), and 28 U.S.C. § 1651(a) (All Writs Act).

Venue lies in this district under 28 U.S.C. § 1391(e). Plaintiff, PPG Industries, Inc. has a chemical manufacturing facility in the district; Standard Chlorine Chemical Company and PPG Industries, Inc. manufacture paradichlorobenzene which is sold in this district. Plaintiff Lagasse Brothers, Inc. is a Louisiana corporation which sells PDCB in this district.

FACTS

Plaintiffs filed a complaint for preliminary and permanent injunctive relief to enjoin defendants from listing PDCB in the proposed Fifth Annual Report on Carcinogens ("Fifth Report") without first "considering the relevant evidence excluded by reason" of the Secretary's criteria for classifying these substances. Plaintiffs contend the Secretary's criteria are arbitrary and capricious and not in accordance with the Public Health Service Act, 42 U.S.C. § 241(b)(4).

The Annual Reports, mandated by the 1978 Amendments to the Act, are prepared by the NTP under delegation from the Secretary. According to Section 262 of Public Law 95-622, amending section 301 of the Public Health Service Act, 42 U.S.C. § 241(b)(4)(A), the Secretary is to publish an Annual Report on Carcinogens which must contain a list of substances which "either are known to be carcinogens or may reasonably be anticipated to be carcinogens ... to which a significant number of persons residing in the United States are exposed...." 42 U.S.C. § 241(b)(4)(A).

The NTP is a federal health research program which was created in 1978 to, among other things, increase the number of environmental chemicals being tested for carcinogenicity and to disseminate the test results to the public, governmental agencies, and the medical and scientific communities. To date the Department has published four Annual Reports on Carcinogens and has prepared a proposed Fifth Annual Report.

In 1981, the Secretary developed classification criteria to determine which substances are ones that may reasonably be anticipated to be carcinogens, which include the substances for which:

A. 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

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 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.

Under this criteria, positive results are required in multiple (at least two) animal carcinogenicity bioassays in order for there to be sufficient evidence that a substance is one that may reasonably be anticipated to be a carcinogen. A bioassay on a chemical substance is a long-term carcinogenicity study in one sex of one specie of experimental animal. In addition, to be considered for inclusion in the Annual Report, the studies on carcinogenicity must be peer-reviewed, and potential exposure of a significant number of persons residing in the United States must also be demonstrated.

ISSUES

Two issues are before this Court. Defendants have filed a motion to dismiss, alleging that plaintiffs lack both standing and the right to appeal the decision of the Secretary. Also at issue at this time is plaintiffs' motion for a preliminary injunction to preclude the Secretary from including the chemicals at issue in the Fifth Annual Report.

A. MOTION TO DISMISS

Defendants have filed a motion to dismiss alleging several grounds, each of which will be discussed separately.

1. Standing

To have standing "a plaintiff must allege personal injury fairly traceable to the defendant's allegedly unlawful conduct and likely to be redressed by the requested relief" Allen v. Wright, 468 U.S. 737, 104 S.Ct. 3315, 3324, 82 L.Ed.2d 556 (1984). Plaintiffs have satisfied these standing requirements. Plaintiff will suffer lost sales from the adverse publicity which would be caused by the inclusion in the Fifth Annual Report of the chemicals which plaintiffs produce. Both parties admit that the public relies upon the Annual Report as one of the few major sources of objective, peer-reviewed information on carcinogenic substances. A consumer reaction study offered by plaintiffs showed that a significant reduction in usage of mothballs and toilet deodorizers would result from the government's identification or labeling of such products as carcinogens. These lost sales are unlikely to be recovered if PDCB were removed from the Annual Report after being issued by the Secretary; customers are likely to move to competing products and not to return to mothball and toilet deodorizer products containing PDCB.

The Secretary's designation of a substance in the Annual Reports also has a substantial regulatory impact. For example, the Occupational Safety and Health Administration's Hazard Communication Standard requires manufacturers to label as a "carcinogen" every substance listed in the Annual Report. Various state regulatory requirements are also triggered by...