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Civil Action No. 99-1170 (EGS)

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JIM J. TOZZI, et al.,

Plaintiffs,

v.

UNITED STATES DEPARTMENT OF HEALTH & HUMAN SERVICES,

Defendants.

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DEFENDANT’S MEMORANDUM IN SUPPORT
OF ITS MOTION TO DISMISS

I. Preliminary Statement.

Defendants, the United States Department of Health and Human Services ("HHS"); Donna E. Shalala, Secretary of HHS; Kenneth Olden, Director, National Institute of Environmental Health Sciences ("NIEHS") and Director, National Toxicology Program ("NTP"); and George W. Lucier, Director, Environmental Toxicology Program "ETP"), by their undersigned attorneys, have moved to dismiss plaintiffs’ complaint because the plaintiffs seek Administrative Procedure Act ("APA") review of non-final, unripe agency action- the possible listing of dioxin as a known carcinogen in the Ninth Edition of the Report on Carcinogens("RoC").

Plaintiffs’ claims fail because the defendants have not taken any final, reviewable action, and this Court is wholly without jurisdiction over the subject matter of plaintiffs’ complaint. As described below, the RoC itself is an informational document for which no legal rights or consequences flow. As such, even a final, published RoC does not constitute reviewable agency action. The Court need not reach this argument, however, because neither the contested dioxin listing nor the RoC as a whole has been fully reviewed, finally approved or published. As such, it is clear beyond peradventure that the plaintiffs’s claims are not yet ripe. Moreover, plaintiffs do not have standing to bring this action in any event.

Section 301(b)(4) of the Public Health Service Act, 42 U.S.C. § 241 (b)(4), as amended, provides in pertinent part, that:

(t)he Secretary shall publish a biennial report which contains-

(A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed;

(B) information concerning the nature of such exposure and the estimated number of persons exposed to such substances;

(C) a statement identifying (i) each substances contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance...

The statutory requirement for a RoC was enacted in 1978 by Public Law 95-622, 92 Stat. 3412, 3435-36. The statute was amended in 1993 by section 2009 of Public Law 103-43, 107 Stat. 122, 213 to provide for a biennial rather than an annual RoC. In its report on the Biomedical Research and Research Training Amendments of 1978, the house Committee on Interstate and Foreign Commerce made it clear that the RoC had been proposed in response to recommendations by scientists that a list of all known or suspected carcinogens be made available as part of a program to inform and educate both the public and health care professionals of the risk of environmental, dietary and occupational exposure to carcinogens. H.R. Rep. No. 1192, 95th Cong., 2d Sess., at 18-22, 28. (See Attachment 1.)

The House Committee report described the creation of the RoC as an effort to respond to the recognition that a large fraction of cancers were apparently induced by environmental agents and to educate both the public and health professionals. The House Report stressed the informational nature of the RoC:

This report must include information concerning the nature of such exposure and the estimated number of persons exposed to such carcinogens as well as an evaluation of the efficacy of existing regulatory standards designed to reduce or eliminate exposure to carcinogens....Id. at 22

The committee intends that this should be a comprehensive document containing an updated list of all known or suspected carcinogenic agents, the nature of exposure, and the approximate number of persons exposed to such agents....Id.at 28.

The legislative history makes clear that the RoC was intended to be an informational, not a regulatory, document. It was designed to identify human carcinogens or reasonably anticipated human carcinogens. The RoC does not provide a quantification of carcinogenic risk. It discusses individual substances, mixtures of chemicals, or exposure circumstances associated with technological processes which are known to be human carcinogens or which may reasonably be anticipated to be human carcinogens. Quantitative assessments of carcinogenic risk are the purview of other Federal, as well as State and local, health regulatory and research agencies.

The RoC’s enabling statute does not provide criteria for listing a substance as a known carcinogen or as reasonably anticipated to be a carcinogen. Criteria for such listings were first promulgated and published by HHS in December 1982. Revised criteria for listing a substance in the RoC were approved by the Secretary, HHS, and published on September 26, 1996 at 61 Fed. Reg. 50499. The revised criteria are as follows:

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.

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 factors, could not adequately be excluded, or

There is sufficient evidence of carcinogenicity from studies in experimental animals which indicates there is an increased incidence of malignant and/or a combination of malignant and benign tumors: (1) in multiple species or at multiple tissue sites, or (2) by multiple routes of exposure, or (3) 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, substance or mixture 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 a known to be human carcinogen, or reasonably anticipated to be human carcinogen or there is convincing relevant information that the agent acts though mechanisms indicating it would likely cause cancer in humans.

Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgement, 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 (sic), genetic factors, 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.

Within the Department of Health and Human Services, the responsibility for preparing the Reports has been delegated by the Secretary of HHS to the National Toxicology Program (NTP). Dr. Kenneth Olden is the Director, National Toxicology Program, as well as the Director, National Institute of Environmental Health Sciences (NIEHS). Both programs are located in Research Triangle Park in North Carolina. NIEHS is one of the institutes on the National Institute of Health. Dr. George Lucier is Associate Director of the NTP and his staff is primarily responsible for the review and drafting of the RoC.

Final approval and publication of the RoC is preceded by a six step review process. As part of this review, two federal scientific review groups and one non-government scientific peer-review body (a subcommittee of one of the NTP Board of Scientific Counselors) evaluate the substances that are candidates for listing in the RoC. Each group reviews available data relevant to the carcinogenicity of substances. There are multiple opportunities for public comment during the processing of the RoC.

The review process begins when nominations for listing or delisting an agent, substance, mixture or exposure circumstance are submitted to the NTP. The proposed substances are announced in the Federal Register, trade journals, and NTP publications to solicit public comment. The nominations and comments are then first evaluated by an NIEHS/NTP Report on Carcinogens Review Committee (known as "RG1"). The RG1 is composed of scientists from NIEHS and NTP. If the nomination is considered to warrant formal consideration, a search of pertinent databases will be performed and available citations will be reviewed and a draft background document containing all relevant information for application of the criteria for listing is prepared. The RG1 formally reviews the nomination and makes a recommendation concerning listing or delisting to the Director, NTP.

The second review phase is done by the NTP Executive Committee’s Interagency Working Group fr the RoC (known as "RG2"). The RG2 is composed of scientists from a number of federal agencies, who consider the nomination, background document and public comments. Upon completion of its review, RG2 will provide comments and recommendations for changes or additions to the draft background document and also make its recommendation to the Director, NTP, for listing or delisting the substance.

The third review phase is performed in an open, public forum by a subcommittee (known as the NTP Board RoC Subcommittee) of the NTP Board of Scientific Counselors, a chartered advisory committee. Prior to the public meeting, a notice is published in the Federal Register, trade journals, and NTP publications soliciting public comment on the nominations. Background documents are made available to the public upon request. The nominations and all related materials are then reviewed in a public meeting and there is an opportunity for the submission of both written and/or oral comment during the review meeting. Upon completion of its review, the NTP Board RoC Subcommittee provides comments and recommendations for any changes/additions to the draft document and a recommendation is made to the Director, NTP, fr listing or delisting the substance.

Upon completion of the review of the three scientific groups, a list of those agents which are recommended for listing or delisting is published in the Federal Register, trade journals and NTP publications, and final public comment is solicited. The recommendations of the RG1, the RG2 and the NTP Board RoC Subcommittee and all public comments are then presented to the NTP Executive Committee, an interagency group, for the fourth review phase, including comment and recommendations to the Director, NTP.

Fifth, the NTP Director takes the four independent recommendations from the RG1 and the RG2, the NTP Board RoC Subcommittee and the NTP Executive Committee, and reviews the proposed listings and makes decisions as to what to keep and/or delete from the proposals. The NTP Director then submits the final draft RoC to the Office of the Secretary, HHS. The sixth and final review of the RoC is performed by the Office of the Secretary. Upon final review and approval by the Secretary, the RoC is submitted to Congress and a notice is published in the Federal Register identifying all newly listed or delisted substances and announcing the publication and public availability of the latest version of the RoC.

A notice announcing the intent to review dioxin for possible listing in the 9^th RoC as a "known human carcinogen" was published in the Federal Register on July 11, 1997. See 62 Fed. Reg. 37272-73; Cmplt. at ¶50.¹ Dioxin had previously been listed in the RoC as "reasonably anticipated to be human carcinogen." Id. The RG1 has met and recommended that dioxin be listed as a known human carcinogen. Cmplt. at ¶52. The RG2 has met and also recommended that dioxin be listed as a known human carcinogen. Cmplt. at ¶52. Thereafter, another notice was published in the Federal Register on October 2, 1997, soliciting comments on the nominated substances including dioxin. See 62 Fed. Reg. 51674-75. The NTP Board RoC Subcommittee met on October 30 and 31 and voted 4 yes, 3 no, and 1 abstention to recommend listing dioxin as a known human carcinogen. Cmplt. at ¶68. On March 19, 1998, a notice was published in the Federal Register soliciting final public comments on the nomination of dioxin. See 63 Fed. Reg. 13418. Following his review of the proceedings, Dr. Olden ordered a re-review by the Board RoC Subcommittee. See 63 Fed. Reg. 18435; Cmplt. at ¶¶ 71, 73. The public comment period was extended until June 15, 1998, and written statements were again requested in addition to oral presentations for the meeting of the NTP Board RoC Subcommittee on December 2 and 3, 1998. See 63 Fed. Reg. 18435 and 63 Fed. Reg. 57132-33. On re-review, the NTP Board RoC Subcommittee voted against the upgrade by a vote of 5 yes, 7 no, and 1 abstention. Cmplt. at ¶85. NTP once again solicited final public comments on the nomination of dioxin on December 14, 1998. See 63 Fed. Reg. 68783-68785. The NTP Executive Committee subsequently voted on February 24, 1999, to recommend listing dioxin as a known human carcinogen. See Lucier Declaration, Attachment 2. ² Contrary to plaintiff’s assertions, Dr. Olden did not vote at this meeting, and the vote was not unanimous, it was 8 in favor and 1 against. Id. The recommended dioxin listing is currently under consideration by Dr. Olden.³

According to the complaint, plaintiffs Beduci and Greenbaum & Gilhooley’s are restaurants, plaintiff Empire State Restaurant & Tavern Association is a trade association representing thousands of restaurants in New York State, and plaintiff Jim Tozzi is an investor in the Beduci restaurant. Plaintiffs four putative causes of action may be summarized as follows: First, plaintiffs allege that the defendants have misapplied their own criteria for listing dioxin in the RoC as a known human carcinogen. Cmplt. at ¶¶ 100-103. Second, plaintiffs allege that, during the admittedly ongoing review process for the dioxin listing in the RoC, defendants have presented evidence of dioxin’s carcinogenicity in a misleading manner to the various scientific review committees. Cmplt. at ¶¶ 104-105. Third, plaintiffs allege that defendants have relied on improper and insufficient evidence upon which to list dioxin as a known human carcinogen. Cmplt. at ¶¶ 106-111.

Plaintiffs seek review of the "Defendants’ position to date," (Cmplt.. at p. 35, prayer for relief), regarding the type and degree of evidence required to list dioxin as a known human carcinogen. Plaintiffs allege that the defendants’ "position to date" violates the very criteria that the defendants themselves have promulgated for use in determining whether or not to list a substance as a known human carcinogen. Cmplt. at ¶ 33 and p. 35, prayer for relief. Plaintiffs also seek preliminary and permanent injunctions that would prohibit the defendants from listing dioxin as a known human carcinogen unless and until the defendants conform to plaintiffs’ interpretation of defendants’ own listing criteria. Id.

Plaintiffs concede, as they must, that the Ninth Edition of the RoC has not yet been published. Cmplt. ¶ 43. Rather, plaintiffs assert that "if approved and published," (Cmplt. at ¶ 108), the dioxin listing in the Ninth RoC would injure plaintiffs economically "due to the creation of a ‘food scare’ ", resulting in reduced public consumption of meat, poultry, fish and dairy products. Cmplt. at ¶¶ 39, 40. Defendants do not assert that they will face any additional regulatory or statutory constraints even if dioxin is listed as a known carcinogen in the Ninth RoC.

Plaintiffs’ complaint, at root, seeks to prevent the listing of dioxin in the Ninth RoC as a known human carcinogen. Plaintiffs putative injury will occur only when, and if, dioxin is in fact listed as a known carcinogen in the Ninth RoC. Cmplt. at ¶¶ 40, 108. Plaintiffs do not allege that they have already suffered any injury as a result of the interim actions taken by the scientific review committees thus far.

Under Article III, § 2 of the Constitution, this Court can only exercise its jurisdiction over a dispute presenting a justiciable "case or controversy." Wyoming Outdoor Council v. U.S. Forest Service, 165 F.3d 43, 47 (D.C. Cir. 1999); see also Allen v. Wright, 468 U.S. 737, 750 (1984). As an initial, matter the Court must examine its authority to hear a case before addressing the merits of the claims. Steel Co. v. Citizens for a Better Environment, 523 U.S. 83, 118 S. Ct. 1003, 1012-13 (1998). Here, the jurisdictional and prudential doctrines of ripeness and standing preclude this Court’s review of plaintiffs’ claims.

As set forth below, plaintiffs’ claims are unripe, and this Court is wholly without jurisdiction to decide them because the defendants have not taken any final agency action. Moreover, the plaintiffs do not have standing to sue because, even assuming arguendo that the defendants have taken final action, the plaintiffs have not shown that they will be harmed in any concrete and particularized way. Finally, the published, final RoC is an informational document only, and as such is unreviewable in any event.

The constitutional "ripeness requirement is designed to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreement over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way.’ " Ohio Forestry Association v. Sierra Club, 523 U.S. 726, 118 S. Ct. 1665, 1670 (1998), citing Abbott Laboratories v. Gardner, 387 U.S. 136, 148-49 (1967). In deciding whether an agency’s decision is ripe for judicial review, the Court has to examine both the "fitness of the issues for judicial decision" and the "hardship to the parties of withholding court consideration." Ohio Forestry, 118 S. Ct. At 1670; Abbott Laboratories, 387 U.S. at 149. The Supreme Court has recently reaffirmed that a claim is unripe "if it rests upon contingent future events that may not occur as anticipated, or indeed, may not occur at all." Texas v. United States, 523 U.S. 296, 118 S. Ct. 1257, 1259 (1998) (quotations and citations omitted).

This complaint presents the classic model for an unripe case; the issues presented are neither fit for review nor will plaintiff suffer any hardship resulting from the timing of the review. At root, plaintiffs seek to prevent dioxin from being listed as a known human carcinogen in the Ninth RoC. Plaintiffs assert that such a listing will hurt them economically. Yet plaintiffs do not know, nor does anyone yet, if dioxin will in fact be so listed. Review by the Court at this time of defendants’ interim actions would amount to an unjusted entanglement over administrative policies prior to the formalization of any decision by the agency. See Ohio Forestry, 118 S.Ct. at 1670.

In particular, this case is controlled by the Court of Appeals’ very recent, analogous decision in Pfizer, Inc. v. Shalala, WL 498553, 7-16-99, (D.C. Cir.). In that case, Pfizer, Inc. sought to prevent the Food & Drug Administration ("FDA") from granting a generic drug manufacturer a license to produce a putative copycat, generic drug. Id. At 1. In accepting the generic manufacturer’s abbreviated new drug application ("ANDA"), the FDA made certain initial findings that the application was sufficiently complete to permit substantive review. Id. At 2. Moreover, during the course of the litigation, the FDA "tentatively approved" the generic drug. Pzifer argued that the tentative approval was tantamount to final approval because the tentative approval was conditioned only on the expiration of a statutory 30 month time lapse and the manufacturer’s assurance that there would be no new information affecting the decision prior to final approval. Id. at 5. While the Court held that the FDA’s tentative approval made it "more likely" that the generic drug would in fact be approved, it held that Pfizer’s claim was still unripe because final approval could not occur until December, 1999 and because Pfizer could bring its claim then. Id.

Here, the absolute most that one could argue has happened to the proposed Ninth RoC is that it has been "tentatively approved." But, as in Pfizer, such interim approval is an insufficient basis upon which to justify this Court’s review. Moreover, in Pfizer, no further substantive review to the ANDA was expected prior to final approval. Such is not the case here. Although the committee review process has already taken place, both the office of the NTP Director and the Office of the Secretary, HHS, will substantively review the proposed RoC. Therefore, the Court should abstain from its review at this time.

Moreover, the proposed RoC is also not "fit for review" because it is not "final agency action" under the APA as well.⁴ See 5 U.S.C. § 704. Under section 704 of the APA, the Court can only review "final agency action." Agency action is "final when it imposes an obligation, denies a right, or fixes some legal relationship.’" Action on Smoking and Health v. Department of Labor, 28 F.3d 162, 165 (D.C. Cir. 1994), quoting NRDC v. United States Nuclear Regulatory Comm’n, 680 F.2d 810, 815 (D.C. Cir. 1982).

In State of California v. Department of Justice, 114 F.3d 1222 (D.C,. Cir. 1997), the plaintiff State of California sought a writ of mandamus and declaratory and injunctive relief that would force the Department of Justice to reimburse California for its cost in incarcerating undocumented illegal aliens. Congress had appropriated monies for such reimbursement, and the Attorney General was statutorily charged with deciding how the appropriated money should be spent. However, at the time plaintiff brought its action, the Attorney General had not yet made a final decision about how much money would go to California. Because no legal consequences, obligations or rights had been fixed by the mere appropriation of the money, the Court of Appeals tersely and decisively held that the action was unripe. "No final administrative decision, no judicial review." Id. at 1225.

The same holds true in this case. Like the Attorney General in State of California, supra, the Secretary of HHS is statutorily charged with taking final agency action, here in the form of publishing the RoC. Because that has not happened the Court is without jurisdiction to consider the merits of plaintiffs’ claims. See also Federal Trade Comm’n v. Standard Oil Co., 449 U.S. 232, 238-240 (1980) (administrative complaint brought by FTC against oil company was mere interim, non-final procedural step under the APA and oil companies’ lawsuit seeking to strike agency complaint as arbitrary and capricious was therefore unripe).

Plaintiffs effectively concede that they do not and cannot know if dioxin will in fact be listed as a carcinogen in the Ninth RoC. See, e.g., Cmplt. at ¶ 108 ("if approved and published" . . . the Ninth RoC "would cause plaintiffs injury") (emphasis added). If dioxin is not listed as a known carcinogen, a ruling by the Court would be unnecessary. Courts should generally deem an issue not "fit" for review when resolution of the dispute may be unnecessary. See Florida Power & Light Co. v. Environmental Protection Agency, 145 F.3d 1414, 1421 (D.C. Cir. 1998).

Indeed, as described above, the proposed dioxin listing has already had an unusual history, It has been subjected to two separate votes at the NTP Board RoC Subcommittee stage, the third, public stage of review. Both votes at that stage were close, with one vote resulting in a 4 to 3 decision to list dioxin as a known carcinogen, and another vote resulting in a 7 to 5 decisio against the upgraded listing. Cmplt. at ¶¶ 68, 85. These facts alone militate in favor of deferring this Court’s review until the dioxin listing has in fact been finally decided.

Plaintiffs seek to bolster their claim to review by asserting that the proposed dioxin listing as a known human carcinogen "should be assumed." Cmplt. ¶ 37, see also ¶ 90. But plaintiffs erroneously assert that the fourth stage of review, the NTP Executive Committee, was unanimous vote in favor of the upgraded listing, and that Dr. Olden, the Director of the NTP, whose Office is charged with the next, fifth level of review, had voted in favor of the upgraded listing at the NTP Executive Committee level. Id. In fact, the NTP Executive Committee vote was not unanimous, and Dr. Olden did not vote at that meeting in any event. See Lucier Declaration, Attachment 2. Thus, the outcome of the dioxin listing is not a foregone conclusion, and this Court should refrain from analyzing defendants’ interim actions.

Plaintiffs seek to create final, reviewable agency action where there is none by claiming that it is the defendants’ stated interpretation f their own listing criteria which is the final action that plaintiffs’ contest. Cmplt. at ¶ 36. But the defendants’ interpretation of their own listing criteria have no independent impact, force or effect upon the plaintiffs other than in connection with the publication of the RoC. What is particularly telling, and fatal to plaintiffs’ claims, is that plaintiffs do not allege any injury resulting from any of defendants’ interim actions taken thus far. Clearly, the manner in which the defendants have interpreted their own listing criteria thus far has not produced a "food scare." Because no obligations or legal rights have been imposed upon plaintiffs, the matter is unripe. State of California, supra, 114 F.3d at 1225, see also Franklin v. Massachusetts, 505 U.S. 788, 796 (1992).

Moreover, it is ironic that plaintiffs assert that defendants’ interpretation of their own listing criteria is "final" agency action, because in claiming that defendants’ interpretation of their own listing criteria is erroneous plaintiffs point to earlier alleged interpretations by the defendants that plaintiffs claim conflict with the later pronouncements. Cmplt. at ¶¶ 12-18, 91. Thus, plaintiffs’ allegation of "final," reviewable agency action is predicated upon their own assertion that the defendants have improperly shifted their interpretation of their own listing criteria. It is hard to see what is "final" about that, even according to plaintiffs’ (erroneous) allegations. Thus, even assuming arguendo that plaintiffs’ claims are true, premature review such as this would "den[y] the agency an opportunity to correct its own mistakes and to apply its expertise.’" Ohio Forestry, supra, 118 S.Ct. at 1671 (citations omitted).

An additional factor to consider in determining whether the matter is ripe is whether the issue presents a purely legal as opposed to a fact-bound inquiry. See Cronin v. Federal Aviation Admin., 73 F.3d 1126, 1130 (D.C. Cir. 1996). Here, the ultimate determination of the propriety of the dioxin listing is very fact intensive. Because review of dioxin is presently ongoing, the Court would benefit from any further factual development of the record. This is, of course, an APA review case, and the administrative record that defendants would have to present to the Court for its review of this matter cannot now be authoritatively compiled, since additional matters may become part of the record currently under review by defendants at this time.

Thus, this issues in plaintiffs’ complaint surely are not ripe for review. Turning to the "hardship upon the plaintiffs" prong of the review, plaintiffs sole claim for immediate review is that they will be injured when and if the RoC is published. E.g., Cmplt. at ¶¶ 108 & 40 (injury will "occur following" publication). This bare assertion does not meet their burden of showing "a hardship . . . that is immediate, direct, and significant." See State Farm Mut. Auto. Ins. Co. v. Dole, 802 F.2d 474, 479-80 (D.C. Cir. 1986), cert, denied, 480 U.S. 951 (1987); see also Louisiana Environmental Action Network v. Browner, 87 F.3d 1379, 1385 (D.C. Cir. 1996).

The recent Pfizer case is again instructive. There, Pfizer claimed that it would suffer economic injury if the FDA approved the generic drug for commercial use. Pfizer, supra, slip op. at 4. But the FDA had only tentatively, not formally or finally, made such an approval. Thus, as in this case, the plaintiff claimed a threatened injury that it had not yet suffered. On those facts the Curt held that there would be no ‘"irremediable adverse consequences flow[ing] from requiring a later challenge.’" Id. at 4, quoting Toilet Goods Ass’n v. Gardner, 387 U.S. 158, 164 (9167). The same applies here.

The Pfizer Court also focused on the question of whether bypassing review at the present time would foreclose any future meaningful review, and held in that case that it would not. Id. One may clearly infer from the Court’s holding that, assuming Pfizer’s claims to be true, it would suffer some injury prior to bringing a ripe claim. Here, given the speculative nature of plaintiffs’ claims of injury in any event, there is simply no hardship to plaintiffs that would justify reviewing plaintiffs’ claims now. Plaintiffs may bring their claims when the RoC is finally and formally published.

Thus, plaintiffs’ claims are not ripe for review and their case should be dismissed at this time.

The well-known elements of standing are threefold. First, plaintiffs must allege (and prove) "injury in fact," which must be "concrete and actual or imminent, not conjectural or hypothetical . . . Second, there must be causation - as fairly traceable connection between the plaintiff’s injury and the complained-of conduct of the defendant . . . And third, there must be redressability - a likelihood that the requested relief will redress the alleged injury." Steel Co., supra, 118 S.Ct. at 1016; see also Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992); Valley Forge Christian College v. American United of Separation of Church and State, Inc., 454 U.S. 464, 472 (1975).

It is the plaintiff’s burden to allege and prove standing. See FW/PBS, Inc. v. Dallas, 493 U.S. 215, 132 (1990). Moreover, where, as here, plaintiff seeks only declaratory and injunctive relief, "there is a further requirement that [plaintiff] show a very significant possibility of future harm." San Diego Gun Rights Committee v. Reno, 98 F.3d 1121, 1126 (9^th Cir. 1996); see also Federal Express Corp. v. Air Line Pilots Ass’n, 67 F.3d 961, 963 (D.C. Cir. 1995) (standing requirements are "no less strict" when a party seeks declaratory judgment).

Plaintiffs’ sole claim of injury is the asserted "creation of a ‘food scare’, resulting in reduced public consumption of meats including poultry, dairy products, and fish. Plaintiffs would also face the practical necessity of expending effort and money attempting to locate and provide such foods which are not so contaminated." Cmplt. at ¶ 39. Importantly, plaintiffs have not asserted that they will face any additional regulatory or administrative constraints or hardship if dioxin is listed as a known carcinogen. They have not asserted, nor can they, that the publication of the Ninth RoC will automatically set in motion any legal norm or obligation to which they must adhere.

The claim of economic injury due to a "food scare" is completely speculative, nor is it in any way "concrete" or particularized. Even assuming arguendo that dioxin were to be listed as a known human carcinogen in the Ninth RoC, plaintiff has presented no evidence that a "food scare" will result. That dioxin is carcinogenic and a hazardous substance is already widely known. The Working Group of the International Agency for Research on Cancer (IARC) in a report published in 1997 concluded that dioxin was carcinogenic to humans. E.g., Cmplt. at ¶ 51. The EPA already regulates dioxin as a hazardous waste and toxic pollutant under the Clean Water Act (CWA), 40 CFR, § 132.6; the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 40 CFR § 173.2; the Resource Conservation and Recovery Act (RCRA), 40 CFR §§ 261, 266, 268; the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 40 CFR § 3024 and the Toxic Substances Control Act (TSCA), 40 CFR §§ 707, 766. The FDA regulates dioxin in beverages, specifically bottled water. See 21 CFR § 165.110. NIOSH has recommended the exposure limit to dioxin be the lowest feasible concentration. OSHA regulates dioxin under the Hazard Communication Standard and as a hazardous chemical in laboratories. See 29 CFR § 1910.1450. Exhibits 5 and 6 to plaintiffs’ complaint indicate that both the cities of San Francisco and Oakland have passed resolutions to eliminate dioxin, stating that dioxin is "believed to be the single most carcinogenic chemical known to science." Moreover, dioxin is, of course, already listed in the RoC as a suspected carcinogen. Given the highly regulated nature of dioxin at the present time, it is most unlikely that a "food scare will occur if dioxin is listed as a known carcinogen in the Ninth RoC.

Plaintiffs have cited no statistics, studies or affidavits on the expected impact when and if dioxin is listed as a known carcinogen. Nor have they provided the Court with any indication of which foods they serve that contain dioxin or how much. The mere possibility that someone, somewhere may attempt to reduce consumption of food containing dioxin is simply not enough to support standing for these plaintiffs. In Alaska Legislative Council v. Babbitt, WL 485138, 7-13-99, (D.C. Cir.) at 5, the Court of Appeals held that plaintiffs had no standing where the implementation of the contested Act possibly "could reduce the opportunities for hunters and fishermen," but had no particular effect upon the plaintiffs. The Court held that "[p]leadings must be more than "an ingenious academic exercise in the conceivable.’" Id. (quoting United States v. SCRAP, 412 U.S. 669, 688 (1973)).

Not only is the asserted food scare "an ingenious academic exercise in the conceivable," even if it did occur plaintiffs have presented no evidence as to why it would uniquely affect them. They have not presented affidavits or statistics as to the demographics of their patrons, such as age or sex or any other description that might then be compared with statistics or affidavits indicating which foods in particular are likely to contain dioxin and who typically eats such foods. Thus, the Court has no information whatsoever concerning which foods contain dioxin, where those foods come from or what expense and effort plaintiffs would undergo to provide non-contaminated food. Given the speculative nature of plaintiffs’ asserted harm, such information is necessary. See Animal Legal Defense Fund, Inc. v. Glickman, 154 F.3d 426, 440 (D.C. Cir. 1998) (standing justified where plaintiff submitted detailed affidavit outlining the "personal and individual way" that he suffered aesthetic harm by witnessing animals living under inhumane conditions).

Plaintiffs have not presented any reason why they, as opposed to anybody and everybody else who might learn of the still-hypothetical dioxin listing, would be particularly affected. Such "abstract or generalized interest[s]" cannot provide a basis for standing. Federation for Am. Immigration Reform, Inc. v. Reno, 93 F.3d 897, 901-02 (D.C. Cir. 1996), cert. denied, 117 S. Ct. 2510 (1997) (an injury common to the entire population seems particularly well suited for redress in the political rather than the judicial sphere).

As the Supreme Court has held, "standing to sue may not be predicated upon an interest . . .which is held in common by all members of the public, because of the necessarily abstract nature of the injury all citizens share." Schlesinger v. Reservists Committee to Stop the War, 418 U.S. 208, 220 (1974). Citizens at large simply do not have a justiciable interest "in having the Executive Branch act in a lawful manner." Common Cause v. Federal Election Comm’n, 108 F.3d 413, 419 (D.C. Cir. 1997). Because plaintiffs have not and cannot demonstrate a harm that is concrete and particular to them, they have not demonstrated the required standing to sue.

Once the Ninth RoC is published, while it may be "final" action, it is nevertheless merely an informational document, and as such is not subject to review under the APA.

Reviewable agency "rules" under the APA are defined as "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy." 5 U.S.C. § 551(4). The Court of Appeals has held that "Congress did nt intend that [this definition] be construed so broadly that every agency action would be subject to review." Industrial Safety Equipment Association, Inc., et al. v. EPA, et al., 837 F.2d 1115, 1119 (D.C. Cir. 1988).

In determining whether final agency action is subject to judicial review, the Court should examine several factors including (1) the agency’s own characterization of the action, (2) whether or not it is published in the Federal Register or Code of Federal Regulations, (3) and whether it has a binding effect on parties’ rights and n the agency’s ability to exercise discretion in the future. Portland Cement Alliance v. EPA, 101 F.3d 772, 776 (D.C. Cir. 1996).

Here, Congress itself has characterized the RoC as an informational document, not a regulatory one. The legislative history behind the RoC makes it perfectly clear that Congress did not intend that the RoC implement policy or have the force of law. Rather, the RoC was intended to be a "comprehensive document containing an updated list of all known or suspected carcinogenic agents, the nature of exposure and the approximate number of persons exposed . . ." H.R. Rep. No. 1192, 95^th Cong., 2d Sess., at 28. (See Attachment 1.) While the RoC was also intended to provide scientists an opportunity to evaluate the "efficacy of appropriate existing regulatory standards," id., of carcinogenic materials, Congress did not mandate that any federal regulations be updated or altered in any way as a result of anything published in the RoC. Thus, the RoC has no regulatory "bite," it is intended solely as a informational document, and as such was not meant to be reviewed under the APA.⁶

The second factor to consider is whether the RoC is published in the Federal Register or the Code of Federal Regulations. "[T]he real dividing point between regulations and general statements of policy is publication in the Code of Federal Regulations." Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 539 (D.C. 1986). Here, the RoC is not published in the Federal Register. Rather, a notice is published in the Federal Register announcing the availability of the RoC and providing a summary of newly listed substances. See Attachment 3. Moreover, no part of the RoC is published in the Code of Federal Regulations.

Finally, the RoC does not have a binding effect on anyone or any federal or state agency. Rather, as described above, it is essentially an informational document listing suspected or known carcinogenic substances. Certainly the RoC has far less coercive effect than the EPA report at issue in Portland Cement, supra, 101 F.3d at 777. That report affirmatively stated that a particular hazardous substance, cement kiln dust, did not warrant identification and regulation under the existing comprehensive RCRA regulatory scheme because to do so would be "prohibitively burdensome" to the cement industry. Id. at 774, 776-777. Despite the apparently definitive pronouncement that cement kiln dust was not subject to a particular regulatory scheme, the Court held that the report was intended more as an announcement of EPA’s intent to uniquely regulate cement kiln dust in the future. Id. Moreover, the Court made this decision against EPA’s wishes; the EPA argued that the report was reviewable. Id. at 773.

Additionally, in Industrial Safety Equipment, supra, 837 F.2d at 1121, our circuit court held unreviewable, on similar grounds, a published guide by the National Institute for Occupational Safety and Health ("NIOSH") that ranked 13 different respirators that were designed to protect against asbestos intake. The Guide actually stated that NIOSH and the EPA did "not recommend" using 11 of the 13 respirators listed. Id. at 1117 (emphasis added). Thus, unlike the RoC, which does not give any quantitative assessment if the risk associated with the listed carcinogenic substances, the Guide reviewed in Industrial Safety was explicitly intended to dissuade users from using certain products.

Nevertheless, the Industrial Safety Court held that the Guide was not reviewable under the APA, and the complaint had properly been dismissed with prejudice, because while the Guide provided an opinion on which respirators to use, ultimately that opinion was merely advisory. Id. at 1119. No administrative or legal consequences flowed from the Guide other than consumers’ informed choices, which was held to be insufficient to make the Guide a reviewable "rule" under the APA. The Court noted the previously established rule that the mere fact that an agency action has "substantial impact" does not thereby transform that action into a reviewable rule. Id. at 1121 (citing American Postal Workers Union v. United States, 707 F.2d 548, 560 (D.C. Cir. 1983), cert. denied, 465 U.S. 1100 (1984)).

Here, nothing in the RoC approaches the apparent regulatory impact of the reports in either Portland Cement or Industrial Safety. Given the underlying Congressional intent and the informational nature of the RoC, the Court should hold that the RoC is unreviewable even following its publication.

Plaintiffs’ claims are, at the very least and beyond any doubt, presently unripe because the Ninth Roc has not yet been published. Review of the defendants’ interim actions at this time would be inappropriate. Moreover, the plaintiffs lack standing to bring this claim in any event. Finally, even when published in final form, the RoC is merely an informational, non-regulatory document, and as such is unreviewable.

WHEREFORE, the plaintiffs’ claims should be dismissed.

Respectfully Submitted,

_______________________________
WILMA A. LEWIS, DC Bar #358637
United States Attorney

____________________________________
MARK E. NAGLE, DC Bar #416364
Chief, Civil Division

____________________________________
DAVID L. SMITH, DC Bar #453709
Assistant United States Attorney
555 4^th Street, N.W. Room 10-452
Washington, DC 20001
202/353-9895

Of Counsel:
Patricia A. Kvochak, Esq.
Office of General Counsel
National Institutes of Health

¹Citation references for factual assertions here are either to the Federal Register or to plaintiffs' Complaint. Defendants do not endorse, of course, plaintiffs' Complaint. Defendants do not endorse, of course, plaintiffs' characterization of the facts referred to herein or to matters in the cited complaint paragraphs other than the mere facts referred to.

²The defendants submit the Lucier Declaration (and the other exhibits referred t herein) for the limited purpose of allowing the Court to determine whether it has jurisdiction to consider plaintiffs' claims. It is well-established that when a defendant challenges the substance of the jurisdictional allegations, as defendants do in this case, it may use extraneous evidence to test those allegations, as defendants do in this case, it may use extraneous evidence to test those allegations without converting the motion into a summary judgment motion. See Land v. Dollar, 330 U.S. 731, 735 n.4 (1947); Herbert v. National Academy of Sciences, 974 F.2d 192, 197-98 (D.C. Cir. 1992); Bonterra America, Inc. v. Bestmann, 907 F. Supp. 4, 5 n.5 (D. D.C. 1995); see also Holt v. United States, 46 F. 3d 1000, 1002-03 (10th Cir. 1995).

³Although the defendants cannot predict exactly when the Ninth RoC will be published, based upon past history of the length of time for the remaining levels of review, defendants estimate that the Ninth RoC could be published sometime in the November, 1999 to January, 2000 time frame.

⁴ Plaintiffs claim no basis for review other than the APA. The Declaratory Judgment Act authorizes declaratory relief only where a cause of action created by another statute already exists. See, e.g., Skelly Oil Co. v. Phillips Petroleum Co., 339 U.S. 667, 671 (1950); Burnham Corp. v. Adamkus, 750 F. Supp. 282, 285 (S.D. Ohio 1990) ("an independent source of jurisdiction is needed to grant relief"); see also Benvenuti v. Department of Defense, 587 F. Supp. 348, 351 (D.D.C. 1984). Here, plaintiffs have no other independent cause of action side from APA review.

⁵ In Pfizer the final approval of the generic drug was possible in December, 1999. Id. at 5. A similar time frame for publication of the RoC is presented here.