IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
CIVIL DIVISION

______________________________________

Civil Action No CV:99-1170
Judge Emmet G. Sullivan

JIM J. TOZZI, et al.

Plaintiffs,

v.

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.,

Defendants

______________________________________

PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT

Plaintiffs hereby request, pursuant to Federal Rule of Civil Procedure 56, that the Court order summary judgment in favor of the Plaintiffs. As discussed in the attached Memorandum in support of this motion, there are no genuine issues of material fact in dispute, and summary adjudication is therefore appropriate at this time.

Significant briefing on the key issues in the case has already been submitted to the Court in connection with Defendants’ Motion to Dismiss and Plaintiffs’ Application for Preliminary Injunction. At a status hearing on November 12, 1999 the Court consolidated Plaintiffs’ Application for Injunction with a hearing on the merits and directed that the parties file cross motions for summary judgment. Oral argument is set for February 25, 2000.

This case concerns a proposed upgraded listing for dioxin (tetrachlorodibenzo-p-dioxin or "TCDD") in the 9^th Report on Carcinogens ("RoC"). Defendants propose to change the classification of dioxin from "reasonably anticipated" to a "known" human carcinogen. Plaintiffs, who face significant economic harm if the 9^th RoC is published with the dioxin listing as proposed, maintain that Defendants have acted arbitrarily and capriciously in connection with the dioxin review.

Specifically, as the attached memorandum and previous briefing show, Defendants have disregarded published Health and Human Services and National Toxicology Program criteria for listing substances in the Report on Carcinogens by proposing to list dioxin as a "known" human carcinogen without a finding of "sufficient evidence from studies in humans which indicates a causal relationship" between exposure to dioxin and human cancer. Defendants further have departed from long-standing agency policies and practices for such listings without providing a reasoned justification. In connection with the dioxin review, Defendants have also misrepresented the scientific record on carcinogenicity. Finally, Defendants failed to consider the issue of exposure to chemical mixtures and to account for questions of confounding in connection with the dioxin review.

There are no outstanding material factual issues, and all jurisdictional prerequisites have been met. The undisputed record evidence clearly and unmistakably shows Defendants’ conduct to have been arbitrary and capricious. Plaintiffs are therefore are entitled to summary judgment as a matter of law.

Respectfully submitted,

_____________________________________
CHARLES J. FROMM, DC Bar No. 420021

Multinational Legal Services, P.C.

11 Dupont Circle, Suite 700

Washington, DC 20036
Ph: (202) 797-7124
Fax: (202) 939-6969

Attorneys for Plaintiffs

Dated: December 17, 1999

TABLE OF CONTENTS

Table of Contents..................................................................................................i

Table of Authorities...............................................................................................iii

Statement of Material Facts Not in Dispute................................................................vi

Argument.............................................................................................................1

I. Introduction......................................................................................................1

A. Issues Presented...............................................................................1

B. Procedural Status of the Case......................................................2

II. All Jurisdictional Prerequisites Are Satisfied.............................................3

A. Plaintiffs Meet All Applicable Standing Requirements..........................3

1. The Proposed Ninth Report Threatens Brevet’s Ability to Continue Manufacturing and Marketing Its Medical Equipment Products..............................................................................6

2. The Restaurant Plaintiffs Will Suffer Direct and Particularized Harm From an Official Government Pronouncement that Their Menu Items Are Contaminated With a Known Human Carcinogen...........................................................................9

B. Defendants’ Final Agency Action and the RoC’s Imminent Publication Make the Case Ripe for Adjudication...............................................................12

C. Defendants’ Issuance of the Report on Carcinogens is Reviewable Agency Action..........17

III. Plaintiffs Are Entitled to Judgment on the Merits as a Matter of Law.............19

A. The Standard for Summary Judgment Is Satisfied.................20

B. The Record Establishes that There Is No Genuine Issue of Material Fact With Respect to Defendants’ Disregard and Misapplication of the Known Human Carcinogen Listing Criteria........................................20

1. Previous Briefing Establishes That Plaintiffs Should Prevail On The Merits of Their Claims....................................21

2. The Court Should Demand That Defendants Answer Key Questions Concerning Their Reading of the Listing Criteria and the Application of Those Criteria to Dioxin................27

IV. Conclusion.............................................................30

TABLE OF AUTHORITIES

* Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967).................13, 16, 17

American Bankers Ins. Group, Inc. v. Board of Governors of the Fed. Reserve Sys., 3 F. Supp. 2d 37, 39, 40 (D.D.C. 1998)..........................20

American Portland Cement Alliance v. EPA, 101 F.3d 772 (D.C. Cir. 1996...................18

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986).............................20

* Animal Legal Defense Fund, Inc. v. Glickman, 154 F.3d 426, 431-32 (D.C. Cir. 1998).....................................12

Association of Data Processing Serv. Orgs. v. Camp, 397 U.S. 150, 156 (1970)................................5

* Bennet v. Spear, 520 U.S. 154, 117 S. Ct. 1154, 1160-63 (1997)............................12

Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986)............................17

* Ciba-Geigy Corp. v. United States EPA, 801 F.2d 430, 435-36 & n.7 (D.C. Cir. 1986)...........................16, 17

Clarke v. Securities Indus. Ass’n, 479 U.S. 388, 394-96 (1987)............................5

* Dow Chemical, U.S.A. v. Consumer Product Safety Comm’n, 459 F. Supp. 378, 384 & n.5, 385-87 (W.D. La. 1978)...................................16, 17

Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 75 n. 20 (1978)..........................................5

* Flue-Cured Tobacco Co-op Stabilization Corp. v. United States EPA, 857 F. Supp. 1137, 1143 (M.D.N.C. 1994).........................................13

Freedom Republicans, Inc. v. Federal Election Comm’n, 13 F.3d 412 (D.C. Cir. 1994).........................................16, 19

_____________________

* Authorities upon which we chiefly rely are marked with asterisks. Two copies are bieng supplied to chambers pursuant to the Court’s November 16, 1999 Order.

H & F Enters., Ltd. v. United States, 973 F. Supp. 170, 174 (D.D.C. 1996)...........................................5

Industrial Safety Equip. Ass'n, Inc. v. EPA, 837 F. 2d 1115, 1117 (D.C. Cir. 1988)........................................18

Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992)..................................4, 5

* Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co. 463 U.S. 29, 43 (1983)..............................................27

* Mountain States Legal Found. v. Glickman, 92 F.3d 1228, 1234-35 (D.C. Cir. 1996).............................................4

* National Automatic Laundry and Cleaning Council v. Schultz, 443 F.2d 689, 702 (D.C. Cir. 1971)..................................12, 16

* National Credit Union Admin. v. First Nat’l Bank & Trust Co., 522 U.S. 479, 118 S. Ct. 927, 934 (1998).............................................12

Natural Resources Defense Council v. Thomas, 845 F.2d 1088, 1094 (D.C. Cir. 1988).............................................16

National Resources Defense Council v. Watkins, 954 F.2d 974, 980 n.7 (4^th Cir. 1992).........................................4

Pennell v. San Jose, 485 U.S. 1 (1988)...................................4

Pfizer, Inc. v. Shalala, WL 498553 (D.C. Cir. July 16, 1999).........14, 19

Public Interest Research Group of N.J., Inc. v. Powell Duffryn Terminals, Inc., 913 F.2d 64, 72 (3d Cir. 1990)....................................5

Rhoads v. McFerran, 517 F.2d 66, 67 (2d Cir. 1975)..............................20

Student Loan Marketing Ass’n v. Riley, 104 F. 3d 397 (D.C. Cir. 1997), cert. denied, ___ U.S. ___, 118 S. Ct. 295 (1997)..............................16

* Synthetic Organic Chem. Mfrs. Ass'n v. Secretary, DHHS, 720 F. Supp. 1244 (W.D. La. 1989) ("SOCMA")........................................17, 18, 19

* Traynor v. Turnage, 485 U.S. 535, 542 (1987).........................17

University Med. Ctr. of S. Nevada v. Shalala, 173 F.3d 438 (D.C. Cir. 1999)...................................................16, 19

Village of Elk Grove Village v. Evans, 997 F.2d 328, 329 (7^th Cir. 1993)..................4

* Watt v. Energy Action Educ. Found., 454 U.S. 151, 160 (1981)............................6, 12

STATEMENT OF MATERIAL FACTS NOT IN DISPUTE

1. The Public Health Service Act, 42 U.S.C. § 241(b)(4), as amended, provides in pertinent part that the Secretary of Health and Human Services ("HHS") shall publish a biennial report listing "all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be human carcinogens and (ii) to which a significant number of persons residing in the United States are exposed". (Am. Compl. Exh. 1; Mot. Dismiss at 2).¹

2. The Report on Carcinogens ("RoC"), the above HHS report mandated under the Public Health Service Act, is published following a formally-prescribed six-step review process. (Mot. Dismiss at 5-8).

3. The 8^th RoC was published in May 1998. Substances proposed for listing in the 9^th RoC have been under review since 1997, and the RoC is soon to be submitted to Secretary Shalala for her final approval. The parties anticipate that the 9^th Report will be released in early 2000.

4. Following a lengthy review process involving leading scientists from both the public and within the government during 1995-96, HHS published revisions to its criteria pursuant to which listing determinations for future editions of the RoC are to be made. Those revised criteria state, with respect to listings for the category "Know to be Human Carcinogens":

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.

61 Fed. Reg. 50499-500 (Am. Compl. Exh. 1).

5. Minutes from the 1995-96 meetings at which the revised criteria were adopted, as well as contemporaneous statements from HHS officials, indicate that no substantial change to the "known" criteria was made at this time. Defendants Shalala and Olden approved of the contemporaneous agency statements indicating no changes in the "known" listing criteria were intended. (Am. Compl. Exhs. 2, 3). In addition, the summary minutes of the listing criteria meetings document discussions during which the scientists considered and rejected proposals to broaden the types of evidence that the agency may consider in listing a substance as a known human carcinogen. (P.I. Opp. Exh. 4 at 3-4, 6; P.I. Opp. Exh 6 at 4-5, 8; P.I. Opp. Exh. 7 at 3; P.I. Opp. Exh 11 at 1, 4). See also P.I. Reply at 7-9.

6. No previous editions of the RoC, prior to the proposed 9^th RoC, ever listed a substance as a known human carcinogen without finding that there was "sufficient evidence from studies in humans" or that studies in humans "indicate a causal relationship." See 8^th RoC (P.I. App. Exh. 1). The HHS/NIEHS agencies never explicitly stated -- outside the context of this litigation -- that they were making a substantive revision to the RoC listing criteria, nor have they provided a reasoned explanation and justification for changing their position on the meaning of the listing criteria.

7. An upgraded listing of dioxin (tetrachlorodibenzo-p-dioxin or "TCDD") was proposed for the 9^th RoC in July 1997. (Mot. Dismiss at 8). Dioxin had been listed as a "reasonably anticipated" human carcinogen in the 8^th RoC and in previous RoCs. Id.

8. On September 30, 1997, officials of National Institute of Environmental Health Sciences ("NIEHS"), which administers the National Toxicology Program ("NTP"), released a "Draft Background Document for TCDD" ("DBD") in support of the proposed dioxin listing upgrade. The DBD stated the rationale for that the proposed upgrade and stated that the proposed "known" human carcinogen listing was based on three types of evidence: (1) human studies showing an "association" between dioxin exposure and certain kinds of cancer; (2) studies in experimental animals; and (3) evidence that "indicates a basic similarity in the mechanism of induction" between animal and human responses to TCDD. (Am. Compl. Exh. 9 at RC-1). The DBD remained unchanged a year later, following a re-review of dioxin listing proposal ordered by NIEHS/NTP Director Olden. (Am. Compl. ¶ 68).

9. The first two committees to review the proposed upgraded listing for dioxin (RG1 and RG2) voted in favor of the upgrade. (Mot. Dismiss at 8). The RoC Subcommittee of the NTP Board of Scientific Counselors also voted initially in favor of the upgrade. Id. This initial vote of the RoC Subcommittee was cited by a number of local governments in 1999 in support of regulatory initiatives intended to restrict various activities alleged to contribute to dioxin levels in the environment, including the sale of medical products containing polyvinyl chloride ("PVC") plastic. Am. Compl. Exhs. 5 at ¶ 3 & n. 3, 6 at ¶ 3 & n. 3, and 6A at p.2, ¶ 3 & n. 3.

10. Following additional public comment on the proposed listing, and a re-review of the dioxin listing directed by Defendant Olden, the RoC Subcommittee voted against the proposed upgraded listing for dioxin on December 2, 1998. (Mot. Dismiss at 9; Am. Compl. at ¶ 88).

11. Plaintiff Tozzi and his counsel corresponded repeatedly with HHS/NTP officials and HHS legal counsel during the NTP review process regarding application of the listing criteria to the proposed dioxin upgrade. (Am. Compl. Exhs. 10, 13, 15, 16, 17, 22, 25, 26). This correspondence, along with public comments submitted by Mr. Tozzi, Am. Compl. Exhs. 11, 23, explained that, under the 1996 published RoC listing criteria, NTP could not base a "known" carcinogen listing on the types of evidence -- including animal and in vitro data -- identified in the DBD.

12. On January 6, 1999, HHS counsel responded to Mr. Tozzi and his attorney in writing by indicating that use of such data for a known carcinogen listing was permissible under the 1996 revised criteria. (Am. Compl. Exh. 24). HHS subsequently issued "clarifications" to the listing criteria, which were published in the Federal Register in April 1999, confirming the intent of officials to interpret the "known" listing criteria to allow consideration of "all relevant information" based on "scientific judgment". (Am. Compl. Exhs. 27, 28).

13. At the NTP Executive Committee meeting on February 24, 1999, the Committee voted in favor of upgrading dioxin to the known human carcinogen category. (Mot. Dismiss Exh. 2). The representative at the meeting from the Defendant agency voted in favor of the upgrade. The NTP Executive Committee is the fourth and last review committee in the RoC listing review process. (Mot. Dismiss at 7-8).

14. In addition to the DBD’s statements above regarding the types of evidence upon which the proposed dioxin listing is based, the DBD also contains statements identifying "hospital wastes" as one source of dioxin production, and notes that more than 90 percent of human exposure to dioxin occurs through consumption of meat including poultry, dairy products and fish. (Am. Compl. Exh. 4).

15. Plaintiffs fall into two groups: (1) manufacturers of medical equipment made from PVC plastic, and/or dependent on the continued use of PVC in the medical equipment industry, and (2) restaurant owners/investors and a major restaurant association. (Am. Compl. ¶¶ 24-28, 40-41; Brewer Aff. (Exh. 1 hereto) at ¶¶ 4-5; Wexler Aff. and Leonard Aff. (Pl. Opp. Attachments) and resubmitted herewith as Exhibits 2 and 3, respectively).

¹ Plaintiffs use the following abbreviations throughout this filing to refer to previous briefing:

Mot. Dismiss - Defendants' Memorandum in Support of Motion to Dismiss
Pl. Opp. - Plaintiffs' Mem. in Opposition to Motion to Dismiss
Def. Reply - Defendants' Reply to Plaintiffs' Opp. to Motion to Dismiss
P.I. App. - Plaintiffs' Mem. in Support of Appl. for Prelim. Injunction
Def. P.I. Opp. - Defendants' Opp. to Plaintiffs' Appl. for Prelim. Injunction
P.I. Reply - Plaintiffs' Reply to Defendants' Opp. to Appl. for Prelim. Injunction

ARGUMENT

Plaintiffs are small businesses that stand to suffer significant adverse economic impact from a chemical listing in a major environmental health report about to be released by the Department of Health and Human Services ("HHS"). The substance at issue is dioxin (tetrachlorodibenzo-p-dioxin or "TCDD"), and Defendants have indicated their intention to list dioxin as a "known human carcinogen" in the upcoming 9^th Report on Carcinogens ("9^th RoC"). Plaintiffs’ products are directly implicated by the proposed dioxin classification, and therefore Plaintiffs have a significant stake in assuring that the agency has adhered to the published criteria in making this listing.

For the reasons set forth in previous briefing, the above Statement of Material Facts, and the discussion below, Plaintiffs request that the Court grant the injunctive and/or declaratory relief requested in the Amended Complaint and set forth in the attached proposed Order.

This case presents the broad issue of whether a federal agency, directed by Congress to identify and list substances that are either "known" or "reasonably anticipated" to be human carcinogens, may disregard the agency’s own published criteria by which such listings are to be made, and instead list a substance in the "known" category where the undisputed scientific evidence, and the agency’s appraisal of that

evidence, indicates that only the "reasonably anticipated" criteria -- not the "known" criteria -- have been satisfied.

More specifically, published criteria require that RoC listings of known human carcinogens are to be based on a single type and quantum of evidence: "sufficient evidence from studies in humans which indicates a causal relationship between exposure . . . and human cancer." 61 Fed. Reg. at 50499 (Am. Compl. Exh. 1). Defendants, however, have proposed to list dioxin as a known human carcinogen based on a combination of three distinct kinds of evidence: (1) human studies showing only an "association" -- not a "causal relationship"; (2) animal studies; and (3) so-called "mechanism of action" data, much of which is derived from studies of animals and animal and human in vitro data. See Am. Compl. Exh. 9 at RC-1.

Plaintiffs seek an injunction to prevent issuance of the 9^th RoC containing the dioxin listing as proposed. In the alternative, Plaintiffs seek a declaration from the Court that Defendants have failed to follow their own published listing criteria as applied to the review of dioxin.

Following a status conference on November 12, 1999, the Court ordered that Plaintiffs’ claims for injunctive relief be consolidated with proceedings on the merits, pursuant to Federal Rule of Civil Procedure 65(a)(2), and further directed the parties to file cross-motions for summary judgment. (Order entered Nov. 16, 1999). With one significant exception, all issues in this case necessary to the Court’s adjudication of this summary judgment motion have been previously briefed in connection with Defendants’ motion to dismiss and Plaintiffs’ application for preliminary injunction. Plaintiffs incorporate these previous briefs and exhibits herein and will not repeat here all the arguments previously made.¹ This memorandum instead will summarize the principal points for the Court and refer back to previous filings where indicated. Plaintiffs also specifically note any newly cited decisions.

The new issue that has necessitated additional briefing is the entry into the case of Plaintiffs Brevet Industries and Brevet, Inc. (collectively, "Brevet"). Brevet is a small California-based business that manufactures medical equipment connectors from polyvinyl chloride ("PVC") plastic, a substance that has been unremittingly under fire by activist groups for allegedly contributing to dioxin levels in the environment. Plaintiffs anticipate that Defendants will challenge Brevet’s standing to participate in this lawsuit, as they previously challenged the standing of the other Plaintiffs ("restaurant Plaintiffs"). The standing issues relating specifically to Brevet are therefore presented here for the first time.

Defendants argued in their motion to dismiss that Plaintiffs fail to meet the minimum showing of standing needed to sustain the Court’s jurisdiction under Article III. (Mot. Dismiss at 21-25). Defendants’ argument rested on the assertion that Plaintiffs do not meet either (1) the injury in fact, or (2) the "fairly traceable" elements of the three-prong test for standing under Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). Plaintiffs anticipate that Defendants may renew these standing arguments in their cross-motion for summary judgment being filed today.²

With respect to the injury in fact element for standing, Plaintiffs need not demonstrate that the harm threatened is certain to occur. Potential harm is sufficient to satisfy the element of injury in fact. See Mountain States Legal Found. v. Glickman, 92 F.3d 1228, 1234-35 (D.C. Cir. 1996) (increased risk of wildfire from certain logging practices constitutes injury in fact); Village of Elk Grove Village v. Evans, 997 F.2d 328, 329 (7^th Cir. 1993) ("even a small probability of injury is sufficient to create a case or controversy") (citing Pennell v. San Jose, 485 U.S. 1 (1988)). As discussed below, Plaintiffs clearly satisfy the requirement of injury in fact.

The "fairly traceable" requirement is also met. This requirement is not equivalent to the tort requirement of causation. National Resources Defense Council v. Watkins, 954 F.2d 974, 980 n.7 (4^th Cir. 1992). In order to demonstrate that they are more than "concerned bystanders", plaintiffs need only show that there is a "substantial likelihood" that defendant’s conduct caused, or is likely to cause, plaintiff’s harm. See Public Interest Research Group of N.J., Inc. v. Powell Duffryn Terminals, Inc., 913 F.2d 64, 72 (3d Cir. 1990) (citing Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 75 n. 20 (1978)), cert. denied, Powell Duffryn Terminals, Inc. v. Public Interest Research Group of N.J., Inc., 498 U.S. 1109 (1991). The threat of "imminent injury" is sufficient to confer standing. Lujan Defenders of Wildlife, supra, 504 U.S. at 566-67 (emphasis added). As described below, the threat of harm to both groups of Plaintiffs, is fairly traceable to Defendants’ proposed publication of the RoC dioxin listing.

In addition to meeting the requirements for standing under Article III, Plaintiffs meet the prudential requirements for standing because they fall within the "zone of interest" of the applicable statute. (Pl. Opp. at 25-29). As this Court has stated:

The [APA] grants a right of judicial review to persons "adversely affected or aggrieved by agency action within the meaning of a relevant statute." 5 U.S.C. § 702 (1989). To have standing to obtain review of an agency action, plaintiff must allege injury in fact caused by arbitrary and capricious administrative action to an interest within the "zone of interests" protected by statute, executive order or regulation.

H & F Enters., Ltd. v. United States, 973 F. Supp. 170, 174 (D.D.C. 1996) (Sullivan, J.) (citing Clarke v. Securities Indus. Ass’n, 479 U.S. 388, 394-96 (1987)). Here, Plaintiffs fall within the APA’s "generous review provisions", Association of Data Processing Serv. Orgs. v. Camp, 397 U.S. 150, 156 (1970), because their businesses lie within the zone of interests of the statute pursuant to which the RoC is issued, the Public Health Service Act, 42 U.S.C. § 241.

Defendants must refute the standing of all Plaintiffs, including Brevet, if they are to prevail on their standing argument. Once the Court concludes that any one Plaintiff has standing, the Court need not engage in a separate standing analysis with respect to other Plaintiffs. Watt v. Energy Action Educ. Found., 454 U.S. 151, 160 (1981). Previous briefing concerning Defendants’ original standing argument was directed solely at the restaurant Plaintiffs, not at Brevet, which joined the case only after Defendants’ motion to dismiss was filed. Plaintiffs therefore address the standing of Brevet first.

If Brevet does not have standing to challenge the issuance of the RoC’s proposed dioxin listing, then arguably no one does.³ Brevet manufactures disposable plastic connectors for use with PVC tubing and surgical units used during open-heart surgery. Brevet produces, as its foremost product line, both rigid polycarbonate connectors and flexible PVC connectors. Approximately five to ten percent of Brevet’s total revenue comes from the sale of the flexible connectors containing PVC plastic. Brewer Aff. at ¶ 4. More importantly, Brevet’s flexible PVC connectors and its rigid polycarbonate connectors are designed to connect exclusively to flexible PVC vinyl tubing. Brewer Aff. at ¶ 5. Virtually all (over 95 percent) of Brevet’s sales depend upon the continued use of flexible PVC tubing in the medical equipment industry. Brewer Aff. at ¶¶ 5, 10(a).

Brevet’s entry into this lawsuit was prompted in part by recent events in Brevet’s home state of California. In the past year local authorities in three northern California municipalities have passed forceful resolutions calling for the phase out and eventual elimination of PVC plastic products. These resolutions were all based, in part, on a preliminary conclusion of one RoC review panel regarding the carcinogenic characteristics of dioxin, a substance allegedly released into the environment during the manufacture and incineration/disposal of PVC medical equipment. See Am. Compl. Exhs. 5 at ¶ 3 & n. 3, 6 at ¶ 3 & n. 3, and 6A at p.2, ¶ 3 & n. 3. Environmental activist groups have taken direct aim at the PVC industry, including medical equipment companies such as Brevet. These groups, such as the "Zero Dioxin Alliance", intend to "build on the victories" of the government resolutions above. See Exhibit 4, attached hereto, at p. 3 of 4) (announcing meeting of Zero Dioxin Alliance in Oakland, California, on February 23, 2000). They are also keeping a watchful eye on the dioxin listing proposed for the 9^th RoC. See Exhibit 5, attached hereto, at p. 15 of 59.

In addition to identifying dioxin as a known human carcinogen, the proposed RoC refers to "hospital wastes" as one source of dioxin. Am. Compl. Exh. 4 at 2-1, ¶ 2.2. If the 9^th RoC were published with the dioxin listing as proposed, including a finding that dioxin is a known human carcinogen, vocal activist groups would therefore immediately trumpet the 9^th RoC as a formal endorsement of their campaign against the use of PVC. See Exhibit 6 attached hereto (dioxin activist paper describing "medical waste problem").

Brevet has already begun to feel the initial effect of this anti-PVC movement. Under pressure from shareholder groups, as well as Greenpeace and other activist organizations, one of Brevet’s medical equipment customers, Baxter International, announced its intention earlier this year to develop and introduce intravenous systems that do not use PVC tubing. See Exhibit 7 attached hereto. Other major medical equipment purchasers, including Tenet Healthcare, Universal Health Services, Kaiser Permanente and Catholic Healthcare West have indicated they will follow Baxter’s lead and shift away from PVC tubing. See Oct. 6, 1999, E-Wire Press Release (attached as Exh. 8).

The RoC is a widely publicized formal determination and carries the imprimatur of the nation’s foremost health agency. Statements in that document concluding that (1) dioxin is a known human carcinogen and (2) one source of dioxin is "hospital waste", will lead directly to the adverse public reaction, regulatory initiatives, and purchaser de-selections described above. Brevet therefore stands to suffer significant adverse economic harm if the RoC is published with the dioxin listing as proposed.

Defendants themselves recognize the blow that Brevet’s entry into the case deals to their standing argument. In a revealing passage from their motion to dismiss, Defendants stated the following with respect to the restaurant Plaintiffs:

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.

Mot. Dismiss at 22 (emphasis added). Why "Importantly"? One answer is because Defendants believe their standing arguments would apply with less force to a company facing local "regulatory or administrative constraints" as a result of the RoC’s publication. Defendants’ own statement thus belies an understanding that Brevet -- which is confronting increasingly adverse regulatory initiatives in its own backyard -- meets the minimum threshold requirements for standing.

2. The Restaurant Plaintiffs Will Suffer Direct and Particularized Harm From an Official Government Pronouncement that Their Menu Items Are Contaminated With a Known Human Carcinogen.

As previously noted, the Court need not engage in an additional standing analysis for the restaurant Plaintiffs if it finds that Brevet has standing. In the event that the Court does address the standing of the restaurant Plaintiffs, however, the Court should hold that the threatened harm to these Plaintiffs from publication of the RoC as proposed also is imminent, concrete and particularized, and that these Plaintiffs therefore also meet the standing requirements.

First, the threat of harm to the restaurant Plaintiffs is clearly evident. Plaintiffs have explained in earlier briefing (Pl. Opp. at 18-30; P.I. App. 31-37; P.I. Reply at 19-23) that, if the RoC is published as proposed, the restaurant Plaintiffs will be forced into the Hobson’s choice of either (a) serving food products that the nation’s leading health agency has declared are responsible for 90 percent⁴ of human exposure to a known human carcinogen, (b) somehow locating "dioxin-free" supplies of these foods, which would involve extraordinary transportation and certification costs and other business disruption, or (c) changing their menus and foregoing high-revenue dishes in favor of other, limited kinds of food offerings. In opposition to Defendants’ motion to dismiss, Plaintiffs submitted affidavits of Plaintiff Empire State Restaurant and Tavern Association’s Executive Director, Scott Wexler, and Plaintiff Greenbaum & Gilhooley’s owner and vice president, Michael Leonard, describing the costs associated with whichever of these choices is made. These uncontested affidavits are resubmitted herewith as Exhibits 2 and 3, respectively.

Second, Plaintiffs have demonstrated that the threatened harm to the restaurant Plaintiffs would be "fairly traceable" to publication of the proposed dioxin listing. As discussed in Plaintiffs’ opposition to the motion to dismiss (at 23-25), the dioxin scare in Belgium and other parts of Europe earlier this year portrayed vividly how a food-consuming public will react to news that dioxin is widespread in meat and dairy products. Exhibits 5-19 and 23 to Plaintiffs’ opposition to the motion to dismiss recounted the widespread public alarm and the reaction of consumers and government agencies. Shortages of particular foods arose quickly as domestic meats and dairy products were banned and removed from stores and menus. News reports specifically noted the dramatic impact on restaurants as consumers shunned the implicated products. See Pl. Opp. Exhs. 10, 13, 14, 15, 16, 18.

Notwithstanding the enormous predictive value of these events, Defendants discount the Belgium dioxin experience and continue to maintain that the threat of harm to restauranteurs from a dioxin scare in this country is "completely speculative". Def. Reply at 12. Defendants attempt to distinguish the European food scare by noting that in Belgium the dioxin concentrations were "unacceptably high", whereas the RoC will not state what levels of dioxin are acceptable. Def. Reply at 10. The RoC will simply state that dioxin is a "known human carcinogen" found in meat, chicken, fish and dairy and leave it at that.

But this is lack of clarification in the RoC -- which assuredly will lead to headlines such as, "HHS: Dioxin in Meat and Dairy a Known Human Carcinogen" -- is part of the problem, not an excuse for going forward with the RoC’s dioxin publication. Defendants appear confident that the public shares Defendants’ sophisticated appreciation of the word "contaminated", as well as all the RoC’s subtleties, and that the RoC will not be distorted in any way by activist groups or the mainstream press. Plaintiffs, whose businesses are on the line, do not share this confidence.

The evidence shows that European consumers, in their flight from foods branded with the "dioxin" stigma, did not stop to ask about parts per trillion, "mechanistic data", toxicity equivalent levels, the meaning of "hazard" versus "risk", or other nice distinctions. They simply reacted with their feet and (Euro) dollars to government and media statements regarding concern over dioxin levels in certain foods. It is unreasonable to expect American consumers to behave differently.

Third, Defendants argue (Mot. Dismiss at 21-25) that the restaurant Plaintiffs are really no different from the general population and that they therefore do not have a particularized interest in the RoC’s publication. While it may be true that publication of the false and misleading conclusions in the proposed report will indeed have a widespread effect, this is no basis to discount the Plaintiffs’ own concrete and distinct economic interests. As Plaintiffs have explained (Pl. Opp. at 29-30), not every American owns a restaurant, and the economic harm that will befall the restaurant Plaintiffs is qualitatively and quantitatively different from the general harm to the public at large.

The standing cases upon which Plaintiffs principally rely, for purposes of the Court’s November 16, 1999 Order, and which Plaintiffs discussed in opposing the motion to dismiss, are: National Credit Union Admin. v. First Nat’l Bank & Trust Co., 522 U.S. 479, 118 S. Ct. 927, 934 (1998); Bennet v. Spear, 520 U.S. 154, 117 S. Ct. 1154, 1160-63 (1997); Animal Legal Defense Fund, Inc. v. Glickman, 154 F.3d 426, 431-32 (D.C. Cir. 1998); and National Automatic Laundry and Cleaning Council v. Schultz, 443 F.2d 689, 702 (D.C. Cir. 1971). Plaintiffs also rely for the first time on Watt v. Energy Action Educ. Found., supra, for the proposition that the Court need not address the standing of each Plaintiff if it determines that one of the Plaintiffs has standing.

Defendants argued as their first basis for dismissal that the case is not ripe because Defendants have taken no final agency action. (Mot. Dismiss. at 12-21). The thrust of this lengthy argument is that because the RoC has yet to be published -- or at least because Defendant Shalala has not formally approved the RoC for publication -- Plaintiffs’ case is brought too soon.

The ripeness doctrine, however, is to be applied pragmatically, with consideration given to the facts of the particular case, including the passage of time and progression of events during the pendency of litigation. See, e.g., Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967); Flue-Cured Tobacco Co-op Stabilization Corp. v. United States EPA, 857 F. Supp. 1137, 1143 (M.D.N.C. 1994) (employing "a pragmatic approach, as well as a flexible view of finality"). When this suit was filed, Plaintiffs had no way of knowing, prior to the report’s publication, when Defendant Shalala would approve the proposed RoC or direct its release.⁵ By definition, an action for injunction seeks to prevent injury (in this case publication) before such injury occurs.

Defendants themselves initially estimated that the RoC could be released as early as November 1999. (Mot. Dismiss at 10 n. 3). Plaintiffs’ suit therefore was delayed as long as could reasonably be expected while still allowing time for the necessary briefing. Although the anticipated approval and publication dates have now been moved back to early 2000, the RoC’s release nevertheless remains effectively imminent. At the status hearing on November 12, 1999, counsel for Defendants declined to accept a briefing schedule that would have extended into March or April, citing the likelihood that the RoC could be ready for release before that time. Moreover, all meaningful agency review has already occurred. See Pl. Opp. at 13-15.

Plaintiffs have previously distinguished the ripeness cases Defendants cited in their motion to dismiss. See Pl. Opp. at 15-17. Defendants’ only response to this analysis was to challenge Plaintiffs’ reading of Pfizer, Inc. v. Shalala, WL 498553 (D.C. Cir. July 16, 1999). In Pfizer, the court held that no final agency action had occurred where FDA had accepted the drug of plaintiff’s competitor for preliminary review. As Plaintiffs pointed out, however (Pl. Opp. at 16), the D.C. Circuit tempered its non-ripeness conclusion by stating, "This case might nonetheless be ripe if the FDA's acceptance of [the competitor's abbreviated new drug application] somehow foreclosed Pfizer's right ever to get meaningful judicial review. . . ." Pfizer, slip op. at 4.

In their reply, Defendants downplayed the D.C. Circuit’s admonishment in Pfizer regarding the need to consider the practicality of subsequent judicial review in making ripeness determinations. Defendants noted that the Pfizer court implicitly agreed to permit "some competition between the competitor and Pfizer (and therefore some injury to Pfizer) . . . prior to or during Pfizer’s lawsuit subsequent to the FDA’s possible approval of the competitor’s application." Def. Reply at 8.

The point remains that Pfizer involved a case where the wrongful agency action could, at a later date, be redressed by recovery of damages from the competitor. Here, by contrast, there is no meaningful opportunity for later judicial review because, once published, the RoC could not be meaningfully retracted. The damage would be done and would be, in effect, irreversible. Even if damages to Plaintiffs could then somehow be calculated, whom would Defendants have Plaintiffs sue? Defendants themselves are immune from suits for libel and slander under the Federal Tort Claims Act. 28 U.S.C. § 2680(h). Surely Defendants do not suggest that recovery could be had against local governments or Plaintiffs’ own customers who reacted in response to Defendants’ report. Confident nevertheless that Plaintiffs’ claims are merely "speculative," Defendants assert, without citing additional authority, "the mere fact of this possible injury does not foreclose meaningful judicial review." Def. Reply at 9. Without explaining how they would remedy harm that is demonstrated subsequent to the RoC’s publication, Defendants apparently would have the Court permit publication first, and then simply wait and see what happens.

In addition to the fact that the agency review is effectively complete and the RoC’s publication is imminent, Plaintiffs also explained that Defendants’ issuance of a formal agency "clarification" of the listing criteria provides an independent basis for a finding that final agency action has occurred. See Pl. Opp. at 7-12. These formal pronouncements were contained in both correspondence from HHS legal counsel and Defendants’ April 1999 Federal Register notices regarding the listing criteria. (Am. Compl. Exhs. 24, 27, 28). Plaintiffs’ brief cited a host of applicable precedent in which courts recognized and applied the principle that an agency’s issuance of a formal legal opinion, which establishes a policy for future agency decisions, itself constitutes final agency action.⁶

In their reply brief Defendants made no attempt to distinguish these authorities. Instead, Defendants set up a strawman argument that Plaintiffs lack standing to challenge the agency’s legal opinion because no harm flows from the agency’s "interpretation" itself -- as opposed to the resulting publication of the RoC. See Def. Reply at 2-6. This hyper-technical reading of the finality requirement is not supported by the two new cases Defendants cite, however.⁷ The argument is also unpersuasive because, under Defendants’ rule, standing considerations would foreclose review of all formal agency pronouncements that, despite their practical effect, do not in themselves result in immediate harm. See Abbott Labs. v. Gardner, 387 U.S. 136, 149-50 (1967) (finality requirement must be applied in "flexible" and "pragmatic" way); cited in Ciba-Geigy Corp. v. United States EPA, 801 F.2d 430, 435-36 & n.7 (D.C. Cir. 1986) (rejecting "hypertechnical" reading of finality requirement).

Contrary to Defendants’ characterization, therefore, Plaintiffs are not "challeng[ing] the defendants’ listing criteria, rather than publication of the RoC itself." (Def. Reply at 5). Plaintiffs merely point out that Defendants’ published position on the listing criteria was the agency’s "final word on the matter", and therefore supplies an independent basis for concluding that the case is ripe for adjudication. Ciba-Geigy Corp., supra, at 437; see also Dow Chemical, U.S.A. v. Consumer Product Safety Comm’n, 459 F. Supp. 378, 384 & n.5, 385-87 (W.D. La. 1978) (holding that "interim policy statement" pursuant to which CPSC had made "provisional classification" of perchlorethylene as Category A carcinogen was final agency action). The facts surrounding Defendants’ application of that position supply the requisite concreteness to the controversy.

Defendants’ third argument in their motion to dismiss was that the RoC is simply not judicially reviewable, even if ripeness, finality and standing requirements are met. See Mot. Dismiss at 25-29. Plaintiffs countered this argument in their opposition brief, citing Abbott Labs, 387 U.S. 136, 141 (1967), Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986), and Traynor v. Turnage, 485 U.S. 535, 542 (1987), for the strong presumption in favor of judicial review. (Pl. Opp. at 30). Plaintiffs went on to discuss the only court opinion considering the reviewability of the specific report at issue, the RoC. Id. at 30-32. That case, Synthetic Organic Chem. Mfrs. Ass'n v. Secretary, DHHS, 720 F. Supp. 1244 (W.D. La. 1989) ("SOCMA"), expressly held that the RoC was reviewable agency action. 720 F. Supp. at 1249.

The two cases upon which Defendants principally rely, where courts addressed the reviewability of other agency actions, are readily distinguishable. In American Portland Cement Alliance v. EPA, 101 F.3d 772 (D.C. Cir. 1996), the court held that EPA’s administrative "determination" regarding hazardous waste regulation was not reviewable because a separate statute -- RCRA, not the APA -- specifically circumscribed the kinds of agency action that courts could review. The statute "by its plain terms" provided for judicial review of only three types of EPA actions, none of which included the agency determination at issue. 101 F.3d at 775. Likewise, Industrial Safety Equip. Ass'n, Inc. v. EPA, 837 F. 2d 1115, 1117 (D.C. Cir. 1988) addressed contentions that the agency failed to follow the APA notice-and-comment procedures required for "substantive" or "legislative" rules under § 553. See 837 F.2d at 1116, 1119, 1121 & n.11. Plaintiffs in that case did not challenge the agency’s action as "arbitrary and capricious" under APA section 706, or, as stated in the opinion, they did not allege that an agency interpretation of its rules, or a dissemination of damaging information, was "false". 837 F.2d at 1122.

In their reply, Defendants dropped their reliance on Industrial Safety altogether. See Def. Reply at 13-14. Defendants continued to espouse "the principles" of Portland Cement, however, repeating their claim that the SOCMA case was wrongly decided because the court "did not have the benefit" of Portland Cement. Def. Reply at 13; Mot. Dismiss at 26-27 n. 6. Defendants further asserted, without elaboration and somewhat incongruously in this section of their brief, that the SOCMA case "is at odds with the contours of the standing and ripeness doctrines" in the D.C. Circuit. Def. Reply at 13 (citing Pfizer, University Med. Center, and Freedom Republicans, supra).

Defendants’ vague criticisms notwithstanding, the SOCMA decision remains the only case squarely to address the issue of whether the RoC’s publication is judicially reviewable agency action. Moreover, the SOCMA holding is well in keeping with the Supreme Court precedent favoring judicial review discussed above. The SOCMA court explained "the Supreme Court has recognized that the term ‘agency action’ is to be interpreted expansively, as it brings together previously defined terms . . . to assure the complete coverage of every form of agency power." 720 F. Supp. at 1249 (citations and internal quotations omitted). The court found that, "The [HHS] Secretary's adoption of the Classification Procedures and Criteria fits well within the rubric of reviewable ‘agency action’," and also held that issuance of the RoC "is agency action even though it is informational and imposes no sanctions or obligations." Id. (quoting Dow Chem., supra, 459 F. Supp. at 386) ("‘moral suasion’ is a considerably potent force in our society"). Finally, the SOCMA court specifically held that the Secretary’s RoC listing decisions were judicially reviewable. 720 F. Supp at 1250. Defendants’ conclusory dismissal of this crucial precedent therefore should not dissuade the Court from reviewing and redressing the manifest errors in the proposed RoC dioxin listing, as discussed below.

This case turns primarily on a question of law. As noted in the "Issues Presented" section above, and as evidenced by the brevity of Plaintiffs’ statement of material facts, the case involves few if any factual issues. Notwithstanding Defendants’ mischaracter-

ization of the case (Def. P.I. Opp. at 17-18), the Court is certainly not called upon to second guess any agency determination regarding complicated scientific or technical issues, determinations which would be accorded substantial deference. Instead, Plaintiffs ask the Court to hold that, as a matter of law, Defendants’ disregard of their own published listing criteria, as described below and in previous briefing, is arbitrary and capricious and therefore warrants appropriate judicial remedy.

In ruling on cross motions for summary judgment the Court may grant summary judgment only if one of the moving parties is entitled to judgment as a matter of law upon material facts that are not genuinely disputed. Rhoads v. McFerran, 517 F.2d 66, 67 (2d Cir. 1975). This standard applies in cases such as this one where the court has consolidated requests for preliminary and permanent injunction with a merits determination under Federal Rule 65(a)(2). See, e.g., American Bankers Ins. Group, Inc. v. Board of Governors of the Fed. Reserve Sys., 3 F. Supp. 2d 37, 39, 40 (D.D.C. 1998) (Sullivan, J.) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986)).

As summarized in the accompanying Statement of Material Facts not in Dispute and as explained in detail in connection with Plaintiffs’ Application for Preliminary Injunction, Defendants are clearly attempting to list dioxin as a know human carcinogen by resort to data outside the scope of evidence permitted under the 1996 published RoC listing criteria. To mask this blatant disregard for the administrative process, Defendants have adopted a mixed strategy, Defendants (1) allege that the 1996 criteria do not really require that known carcinogen listings be based on "sufficient evidence from studies in humans; (2) say that the animal and other data they now rely on are really data from "studies in humans"; and (3) misstate the record to assert that certain human data (the Bertazzi, et al. study) were not considered by the International Agency for Cancer Research ("IARC"). None of these approaches should be allowed to succeed.

The parties have set forth their essential positions on the merits of Plaintiffs’ claims in connection with briefing of Plaintiffs’ application for a preliminary injunction. Plaintiffs’ reply in support of that application contains the most recent counter-thrust in this argument, and therefore Plaintiffs respectfully refer the court to the previous filings. (P.I App. at 12-31; P.I. Opp. at 12-32; P.I. Reply at 2-19). Following this short summary, Plaintiffs pose a series of key questions that the Court should demand Defendants answer in their summary judgment papers.

To briefly summarize the debate to this point, Plaintiffs allege that Defendants have acted arbitrarily and capriciously in their disregard of the published criteria for known human carcinogen listings and in their misapplication of those criteria to the review of dioxin for the 9^th RoC. Defendants propose to list dioxin in the known category without having found "sufficient" evidence from "studies in humans" which indicates a "causal relationship" between exposure to dioxin and human cancer, as the revised 1996 listing criteria require. Specifically, Defendants are proposing to base the dioxin listing on a combination of (1) "limited" evidence from studies in humans; (2) animal and in vitro data; and (3) so-called "mechanism of action" data, which includes substantial amounts of both animal and human in vitro data. In April, 1999 Federal Register "clarifications" of the listing criteria (Am. Compl. Exhs. 27, 28), Defendants brazenly claimed a right to reinterpret the criteria in a manner that would allow this new combination of data to support a known human carcinogen listing.⁸

Plaintiffs’ argued in their opening brief that Defendants recently expressed new reading of the criteria for the "known" category, and the threatened application of that reading to dioxin, are contrary to the plain wording and meaning of the published criteria, and therefore the agency’s actions are not based on consideration of the "relevant factors", but on irrelevant factors. (P.I. App. at 13-16). Plaintiffs’ memorandum and the attached exhibits explain in detail why a listing in the "known" category, based on "evidence from studies in humans", plainly excludes reliance on studies in animals and in vitro, and how the agency is improperly relying on studies in animals and in vitro to compensate for less than sufficient evidence from studies in humans.⁹ (P.I. App. at 16-17). The brief further points out that the listing criteria require evidence from studies in humans "sufficient" to indicate a "causal relationship", but that the agency has found merely an "association". (P.I. App. at 17-21). Plaintiffs next explained how Defendants’ new reading of the criteria constitutes a substantial departure from established policy and precedent without an adequate reasoned justification. (P.I. App. at 21-25).

Plaintiffs also demonstrated that the principal evidence concerning studies in humans upon which the listing partially relies is not accurately presented and the agency’s explanation for its decision runs counter to that evidence. (P.I. App. at 25-30). First, IARC did not find that the evidence from studies in humans was sufficient to indicate a causal relationship. IARC, instead, specifically found that the evidence was "limited", and therefore not "sufficient" to indicate a causal relationship. Second, the recent Bertazzi, et al. study does not contain any significant new, post-IARC findings, and does not support Defendants’ position. Finally, Plaintiffs noted that the record contains no indication that Defendants’ considered an important aspect of the dioxin listing proposal, namely that the studies Defendants rely on involved mixed occupational exposures, which presented confounding issues, while the proposed listing information focuses on exposure to dioxin apart from such mixtures, particularly as a contaminant in food.

In the merits section of their opposition to Plaintiffs’ application for preliminary injunction, Defendants summarized of Plaintiffs’ argument into three points: (1) the proposed listing is contrary to the plain meaning of the criteria; (2) Defendants departed from past practice without explanation; and (3) Defendants inaccurately described the scientific data. (Def. Opp. at 13)

Defendants attempted to rebut the first and second points by claiming that (a) Defendants’ broad authority to "interpret" the listing criteria as they wish allows them to sidestep the requirement of "sufficient evidence from studies in humans" by reliance on so-called "mechanistic data" for known human carcinogen classifications, and (b) because the revisions allegedly permitting reliance on mechanistic data occurred in 1996, there has been no agency departure from past practice. See Def. Opp. at 14-16.

Absolutely critical to this argument is Defendants’ assertion that a new final paragraph following the listing criteria for "reasonably anticipated" carcinogens applies to (and alters) the listing criteria for known carcinogens as well. Defendants therefore devote considerable briefing to this point. See Def. Opp. at 18-29. The operative words of that final paragraph -- that listings may be "based on scientific judgment, with consideration given to all relevant information" (Def. Opp. at 19), do indeed suggest a looser standard than the strict criteria for listings of known carcinogens, i.e., "sufficient evidence from studies in humans which indicates a causal relationship between exposure. . . and human cancer."

The fatal flaws in Defendants’ argument, however, are that (1) the record simply does not support the assertion that the paragraph was intended to apply to both categories of listings, and (2) the wording of the final paragraph, as interpreted by Defendants, is directly at odds with the plain wording of the "known" criteria. Plaintiffs meticulously refuted Defendant’s characterization of the drafting history, as well as Defendants’ other arguments in this regard, in their reply. See P.I. Reply at 5-12. Defendants’ subsequent claim that mechanistic data may be used to support a known human carcinogen listing when evidence from epidemiological data is less than sufficient (Def. P.I. Opp. at 19-28) therefore must also fail.

Defendants concluded with respect to Plaintiffs’ "third" argument, as summarized above, that a close examination of the scientific record was simply not the province of the Court. Plaintiffs further contended that IARC had failed to consider articles by Bertazzi et al. in reaching the conclusion that the quantum of human evidence indicating carcinogenicity of dioxin is "limited" and not "sufficient". Def. P.I. Opp. at 29-31. In an attempt to gloss over the agency’s failure to address the chemical mixtures and confounding issue, Defendant cite a letter to Plaintiff Tozzi from Defendant Olden that merely contained the agency’s statement that it had decided not to consider the issue. See Def. P.I. Opp. at 31-32.

In their reply brief, Plaintiffs reiterated that the Draft Background Document ("DBD") does not contain any agency finding that there is "sufficient" evidence from studies in humans, or that the evidence from studies in humans shows a "causal relationship" with cancer in humans. (P.I. Reply at 2-3). Plaintiffs added that the agency’s rationale relies on evidence from studies in experimental animals and in vitro, and is therefore not in accordance with the plain wording of the "known" criteria.

Much of Plaintiffs’ reply brief is devoted to a detailed examination of the final descriptive paragraph accompanying the 1996 revised listing criteria and the drafting history and other records surrounding that provision. That paragraph’s language, Defendants argue, allows listings of substances in the RoC based on "scientific judgment" and taking into consideration "all relevant evidence". Defendants’ argument depends entirely on the Court’s finding that this paragraph pertains to the "known" human carcinogen listings.

Plaintiffs first demonstrated that (1) the formatting of the descriptive paragraph following the published criteria, (2) the administrative history, (3) the wording of the provision, and (4) the "logic" of the paragraph’s inclusion in the September, 26 1996 Federal Register publication, all indicate that the provision was intended to apply to listings for "reasonably anticipated" carcinogens only, not to the "known" carcinogen category. (P.I. Reply at 5-12). Plaintiffs further explained how Defendants’ position on the final paragraph is a radical and unexplained change from the pre-1996 criteria, the agency’s contemporaneous interpretation of the 1996 criteria revisions, and the agency’s practice in applying the criteria in all published listings to date. (P.I. Reply at 12-16).

Next, Plaintiffs reply explained how Defendants’ inaccurate and substantial reliance on the IARC Monograph and the 1997 and 1998 Bertazzi, et al. articles fail to support the proposed dioxin listing. This argument is important because it refutes Defendants’ third overall strategy, i.e., attempting to show that additional evidence -- that truly is "from studies in humans" -- was not considered by IARC when IARC declared that such evidence is only "limited".

Finally, Plaintiffs argued in their reply that Defendants have disregarded an important aspect of the evidence on causality by failing to address the issue of worker exposure to chemical mixtures containing dioxin as a contaminant along with other potential carcinogens. (P.I. Reply at 18-19). Defendants therefore have failed to address compounding as an important aspect of the listing issue. (P.I. Reply at 19). Such a failure is arbitrary and capricious. Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co. 463 U.S. 29, 43 (1983).

In that full briefing on the merits has already substantially occurred in the course of Plaintiffs’ application for preliminary injunction, the Court should take the opportunity of the present additional briefing to consider a number of specific questions in light of the foregoing argument. Defendants should be called upon to answer the following questions in the course of their summary judgment briefing:

1. Have not Defendants taken a firm position that a "known" listing can be based on evidence from studies in humans that is not sufficient to indicate a causal relationship, and that the criteria can be satisfied by supplementing "limited" evidence from studies in humans with animal and in vitro data?

2. Can Defendants point to a single instance in which HHS/NTP has published a listing in the "known" category based on epidemiologic evidence which was not found sufficient to indicate a causal relationship?

3. Where has the agency ever put the public on notice that it was making such a substantive change in its criteria as to allow animal and/or in vitro evidence to compensate for evidence from studies in humans that is less than sufficient to indicate a causal relationship?

4. How do Defendants explain Exh. 8 to the P.I. Appl. showing that Defendants Olden and Shalala approved the Departmental press release and Environmental Health Perspectives article supporting Plaintiffs’ position?

5. Where has the agency ever explained and justified its departure from the long-standing position that sufficient epidemiologic evidence is required for listings in the "known" human carcinogen category?

6. How do the 1997 and 1998 Bertazzi et al. publications support the statements made about them in the DBD?

7. Can Defendants specify where in the IARC dioxin monograph IARC found that the evidence from studies in humans showed a causal relationship?

8. Is there any place in the public administrative record where the agency has made a finding that the evidence from studies in humans indicates a causal relationship between dioxin exposure and cancer?

9. The agency’s April 1999 Federal Register notices are described as "clarifications". Where, prior to the initiation of this lawsuit has the agency announced an "interpretation" of the "known" criteria consistent with the position it is taking in this case?

10. Where in the public administrative record has the agency addressed the mixtures/confounding issue?

For the foregoing reasons, and for the reasons set forth in previous briefing identified and described herein, the Court should rule that the proposed dioxin listing is contrary to the published RoC listing criteria, and that Defendants’ and misapplication of those criteria is arbitrary and capricious.

The Court should therefore enter the attached proposed Order enjoining Defendants from publishing the RoC with the dioxin listing as proposed. In the alternative, the Court should enter an Order declaring that Defendants’ have failed to follow their own published listing criteria as applied to the review of dioxin.

Respectfully submitted,

_____________________________________
CHARLES J. FROMM, DC Bar No. 420021
Multinational Legal Services, P.C.
11 Dupont Circle, Suite 700
Washington, DC 20036 Ph: (202) 797-7124
Fax: (202) 939-6969

Attorneys for Plaintiffs

Dated: December 17, 1999

¹ See Fed. R. Civ. P. Rule 65(a)(2).

² Two paragraphs on the subject notwithstanding (see Def. Reply at 6-7), Defendants cannot seriously contend that redressability is at issue here. Even putting aside arguments about the effect of a declaratory judgment, a court order directing that the 9th RoC not be published with the dioxin listing as proposed clearly would redress the harm now threatening Plaintiffs. Likewise, in the event that new epidemiological evidence were later to emerge warranting a revised dioxin listing, Defendants could perhaps upgrade the dioxin classification without disregarding their own listing criteria. That such scientific evidence someday may be found, however, truly is speculation.

³ Brevet's owner and President, Charles Brewer, has filed a detailed affidavit describing the threatened harm to Brevet from the publication of the 9th RoC as proposed. The affidavit of Mr. Brewer was filed in support of Plaintiffs' motion for leave to amend the complaint and is resubmitted herewith as Exhibit 1.

⁴ The Draft Background Document to the proposed RoC states, "More than 90% of the dioxins found in humans in the general population are due to consumption of meat including poultry, dairy products, and fish." See Am. Compl. Exh. 4 at 2-2.

⁵ At the status hearing on November 12, 1999, counsel for Defendants' agreed to the Court's request that Plaintiffs now be afforded reasonable notice of Defendant Shalala's approval of the proposed RoC prior to the report's publication.

⁶ See e.g., Student Loan Marketing Ass'n v. Riley, 104 F. 3d 397 (D.C. Cir. 1997), cert. denied, ___ U.S. ___, 118 S. Ct. 295 (1997); Natural Resources Defense Council v. Thomas, 845 F.2d 1088, 1094 (D.C. Cir. 1988); Ciba-Geigy Corp. v. United States EPA, 801 F.2d 430, 436-37 (D.C. Cir. 1986); National Automatic Laundry and Cleaning Council v. Schultz, 443 F.2d 689, 702 (D.C. Cir. 1971); Dow Chem., U.S.A. v. Consumer Product Safety Comm'n, 459 F. Supp. 378, 384 & n.5, 385-87 (W.D. La. 1978).

⁷ Neither Freedom Republicans, Inc. v. Federal Election Comm'n, 13 F.3d 412 (D.C. Cir. 1994), nor University Med. Ctr. of S. Nevada v. Shalala, 173 F.3d 438 (D.C. Cir. 1999), addresses issues of finality or ripeness. Neither case supports Defendants' implied assertion that requirements of ripeness and finality cannot be satisfied by an agency's issuance of a formal legal position statement.

⁸ Although Plaintiffs use the term "reinterpret" here, Plaintiffs maintain that the 1996 listing criteria are so plain as not to admit the proffered interpretation. Even if Defendants had the right to adopt a new "interpretation", however, their radical departure from the agency's previous construction was offered without reasoned explanation or justification. Defendants' fig leaf -- "clarification" -- in the April 1999 Federal Register notices (Am. Compl. Exhs. 27, 28) certainly cannot shield their action from judicial scrutiny.