IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
JIM J. TOZZI, in his personal capacity, and as
EMPIRE STATE RESTAURANT
GREENBAUM & GILHOOLEY’S
BREVET INDUSTRIES and BREVET, INC.,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES;
U.S. Department of Health and Human Services,
AMENDED COMPLAINT SEEKING DECLARATORY
JUDGMENT AND INJUNCTIVE RELIEF
1. This action seeks to compel the U.S. Department of Health and Human Services ("HHS"), and its subordinate agency, the National Institute of Environmental Health Sciences ("NIEHS"), which is one of the National Institutes of Health ("NIH"), and which administers the National Toxicology Program ("NTP")(sometimes referred to below collectively as "the agency"), to follow their own rules for determining whether a substance -- in this case, 2,3,7,8-tetrachlorodibenzo-p-dioxin ("dioxin" or "TCDD") – can and should be listed as "known to be carcinogenic to humans" in the 9th Report on Carcinogens ("RoC"). Dioxin is currently listed in the RoCs as "reasonably anticipated" to be a human carcinogen, and the agency has proposed to upgrade the dioxin listing to the "known" category.
2. The agency’s criteria and rules for listing a substance in the "known to be carcinogenic to humans" category require that the listing be based on "sufficient evidence of carcinogenicity from studies in humans which indicate a causal relationship" between exposure and human cancer. In the case of dioxin, however, the agency has taken a final position that it can, and will, rely on a combination of human, animal, and in vitro evidence to support listing dioxin in the "known" category. This final agency position is clearly not in accordance with the plain wording of the agency’s listing criteria.
3. Additionally, the agency’s presentation of the evidence from studies in humans to its review committees and officials responsible for the final listing determination places substantial reliance on inaccurate statements and on human studies involving exposures substantially different from the dietary exposures to dioxin described in the proposed listing text.
4. Plaintiffs ask this Court to enter a declaratory judgment that the agency’s current position regarding application of its listing criteria for the "known" category to its dioxin listing proposal is arbitrary, capricious, an abuse of discretion, and not in accordance with law and without observance of procedure required by law. Plaintiffs further ask that the Court enjoin the agency from listing dioxin as "known to be carcinogenic to humans" in the RoC. Plaintiffs also ask the Court to enter a declaratory judgment that the agency’s review and presentation of the scientific evidence that it has presented in support of the proposed listing upgrade of dioxin to the "known" category has been, and is, arbitrary, capricious, and an abuse of discretion. Accordingly, Plaintiffs also ask the Court to enjoin further agency listing action on dioxin unless and until the agency corrects those inaccurate and misleading statements. Finally, Plaintiffs ask the Court to require the agency to address the issue of exposures to multiple substances in combination with dioxin in studies in which the subjects were primarily chemical plant workers, and to explain, if possible, how studies of such workers exposed to multiple other chemical substances in which dioxin was an impurity can be relied upon in determining that dioxin by itself is "known" to cause cancer in humans through ordinary dietary exposures.
5. The RoCs are prepared by the agency pursuant to congressional mandate. On November 9, 1978, Public Law 95-622, the "Community Mental Health Centers Extension Act of 1978", Title II, sec. 262(b)(4), 92 Stat. 3435-36, amended section 301 of the Public Health Service Act, now codified at 42 U.S.C. § 241(b)(4), and directed the Secretary of Health, Education, and Welfare (now the Secretary of Health and Human Services) to prepare an annual report to include, among other things, "a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens. . . ." This directive was amended in 1993 to provide that such report shall be biennial rather than annual. P.L. 103-43, § 209, 107 Stat. 213.
6. The RoCs are intended to serve a dual purpose of (1) providing the general public with information on substances in their environment that cause, or might cause, cancer, and (2) prompting individuals to make personal choices, and appropriate regulatory agencies to take regulatory actions, to reduce or eliminate human exposure to listed substances.
7. The RoCs, and the information contained therein, are publicized widely both by the federal government and by non-governmental entities through print and electronic media, particularly through the Internet.
8. The first RoC was published by HHS in 1981. On May 14, 1998, HHS announced availability of the Report on Carcinogens, Eighth Edition. 63 Fed. Reg. 26818-20. Printing and publication of the 9th RoC is expected sometime between November 1999 and May 2000.
9. Substances are listed, delisted, or have their listings changed in the RoCs through a six-step process:
a. The first step is nomination of a substance and proposal of a listing action to be taken in the next Report on Carcinogens regarding that substance, and consideration of the nomination and proposed action by a committee comprised of personnel from NIEHS, referred to by the agency as the "RG1".
b. The second step is consideration of the nomination and proposed action by a federal inter-agency committee, referred to by the agency as the "RG2". Meetings of the RG1 and RG2 are not open to the public.
c. The third step is consideration of the nomination and proposed action by a committee of non-governmental scientists, the RoC Subcommittee of the NTP Board of Scientific Counselors ( "RoC Subcommittee"), in a public forum with opportunity for written and oral public comments.
d. The fourth step is consideration of the nomination and proposed action by an inter-agency committee called the NTP Executive Committee.
e. The fifth step is review of the recommendations from the first four steps by the Director of the NTP/NIEHS, and his or her recommendations to the Secretary, HHS.
f. The sixth and final step is consideration of the recommendations from the first five steps, and decisions on all proposed listing actions, by the Secretary, HHS. As a practical matter, the Secretary ordinarily accepts the recommendations made by the Director of the NTP/NIEHS.
10. The Secretary of HHS has delegated primary responsibility for administering the RoC program to the Director of the NTP, who is also the Director of NIEHS, currently Defendant Kenneth Olden.
11. Defendants HHS, Shalala, and Olden have jointly published "criteria" specifying the degree of evidence required to list a substance either as "known" or "reasonably anticipated" to be carcinogenic to humans. These criteria are "rules" within the definition of a "rule" under the Administrative Procedure Act, 5 U.S.C. § 551(4), which states that a "‘rule’ means the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy . . . ."
12. Following a lengthy review involving extensive public comment and participation, Defendants Olden and Shalala, on August 15 and September 12, 1996, respectively, approved revised criteria for listing substances in the RoCs. A notice announcing the revised criteria was published in the Federal Register on September 26, 1996 (61 Fed.Reg. 50499). The Federal Register notice compared the language of the revised criteria with the original criteria, highlighting changes/additions in the revised criteria by italics (referred to as "underlining" in the text of the notice). A true and correct copy of this Federal Register notice is attached as Exhibit 1.
13. The September 26, 1996 Federal Register notice states, under the heading "Revised BRC Criteria Known 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. [Italics as in original]
No other changes/additions to the "known" criteria were indicated, either under the above heading or in the notice as a whole.
14. A subsequent portion of the same notice indicated changes/additions made to the "Revised BRC Criteria Reasonably Anticipated To Be Human Carcinogens". The "reasonably anticipated" criteria allowed for consideration of evidence from experimental animal studies and other evidence that is not evidence "from studies in humans". Also under the heading for revisions to the "reasonably anticipated" category, and indicated by italics to be a revision to that category, was a "descriptive" paragraph, the first sentence of which reads: "Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information." That portion of the Federal Register notice gave no indication that this new descriptive paragraph was intended to constitute a revision, especially a substantive revision, to the "known" category.
15. On the same date that the above Federal Register notice was published, Defendant HHS issued an official departmental press release which explained that the only substantive changes in the listing criteria were those made to the criteria for the "reasonably anticipated" category. Defendants Olden and Shalala were aware when they approved the Federal Register notice that this press release would be issued along with the Federal Register notice. A true and correct copy of the press release, titled "Updated Criteria Approved For ‘Anticipated’ Human Carcinogens", is attached as Exhibit 2. (The last line of the release indicates its original release date.) This press release was still available on the NTP Internet website on May 13, 1999, as indicated on Exhibit 2.
16. In describing the revisions to the "reasonably anticipated" category criteria, the September 26, 1996 HHS press release stated:
The criteria have been revised to say, "Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment with consideration given to all relevant information. Relevant information includes, but is not limited to . . . chemical structure . . . data relating to mechanism of action or factors that may be unique to a given substance. [Sic -- no closing quotation marks in original.]
The above language following the quotation marks is identical to language specified as "Revised BRC Criteria Reasonably Anticipated To Be Human Carcinogens" in the September 26, 1996 Federal Register. A subsequent paragraph in the press release also reflected the Federal Register notice in stating that there were no material changes made in the criteria for the "known" category:
The original criteria for listing a substance as a known human carcinogen remain unchanged: that "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."
17. The press release also contained, in its second paragraph, a statement attributed to Defendant Shalala that "The new criteria will allow the listing to be based on broader and more sophisticated criteria", indicating that Defendant Shalala was involved in the drafting, review, and authorization of the press release at the same time she approved the Federal Register notice. Defendant Olden was also quoted in the press release, similarly indicating that he was involved in the drafting, review, and authorization of the press release.
18. The September 26, 1996 revisions to the listing criteria were also explained in an "NIEHS News" article in the August 1996 issue of Environmental Health Perspectives. Environmental Health Perspectives is the official "Journal of the National Institute of Environmental Health Sciences". (Issues of the journal are ordinarily published at least a month after the month indicated on the issue.) The journal is edited by personnel in NIEHS/NTP with responsibility for administering the Report on Carcinogens Program, including Defendant George W. Lucier, who was then, and still is, Co-Editor-in-Chief. The article was titled "BRC Criteria Revised", with the NTP logo at the top next to the title. It stated that the Secretary had approved revisions to the criteria for listing a substance as "reasonably anticipated to be a human carcinogen". Further on, the article stated: "The revised criteria for listing a substance as ‘known to be a human carcinogen’ are substantively unchanged from the former criteria, although the wording was slightly altered." The article said nothing about revisions to the "known" category that would allow for consideration of animal or other evidence not "from studies in humans" in order to list a substance in that category. Volume 104, Number 8, August 1996. Defendants Olden, Shalala, and Lucier were aware at the time the September 26, 1996 Federal Register notice was approved that such an article would be published. As in the departmental press release explaining the revised criteria, Defendants Shalala and Olden were quoted in this article. A true and correct copy of this article is attached as Exhibit 3.
19. A revision to the criteria for the "known" category to allow listing in that category to be based on evidence other than evidence "from studies in humans" -- such as animal or in vitro experimental evidence -- and to allow such non-human evidence to be used to compensate for lack of "sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship", would clearly have been a "substantive" revision to the criteria for the "known" category deserving of notice.
20. Defendants have traditionally placed great reliance on evaluations of the evidence of carcinogenicity from studies in humans carried out by working groups of the International Agency for Research on Cancer ("IARC") and published in IARC monographs.
21. IARC’s listing criteria are not the same as the agency’s, although the agency regards its own usage of the terms "sufficient" and "limited" to describe degrees of evidence as comparable to IARC’s use of those terms. In particular, IARC’s first and highest listing category, entitled "carcinogenic to humans" differs substantively from the agency’s "known" category in allowing, in exceptional cases, evidence not from studies in humans to compensate for "limited" (i.e., not "sufficient") human evidence in support of listing a substance in its highest category.
22. In February 1997, an IARC working group conducted a comprehensive review of the evidence for potential human carcinogenicity of dioxin. The IARC working group evaluated the evidence from studies in humans as "limited", and not sufficient to establish a causal relationship, but voted (by majority vote) to place dioxin in its highest category by relying on "sufficient" animal evidence and other evidence concerning mechanism of action to bolster the "limited" evidence from studies in humans. The results of this review and overall evaluation were published by IARC in IARC Monograph 69.
23. Defendant HHS’s listing criteria do not allow for animal evidence or other evidence not from studies in humans to compensate for lack of "sufficient" human evidence in order to list a substance in the "known" category. The agency nevertheless relied extensively, and incorrectly, on the IARC evaluation of the evidence from studies in humans.
24. Plaintiff Tozzi is a resident of the Commonwealth of Virginia, and is President of Multinational Business Services, Inc. ("MBS"), a corporation with principal offices in the District of Columbia. MBS provides advice, counsel, and representation to numerous clients in international trade matters and in administrative and regulatory matters before federal and state governmental agencies, including listing proposals for the RoC program. Plaintiff Tozzi is also an individual investor in Plaintiff BeDuCi.
25. Plaintiff Empire State Restaurant & Tavern Association, Inc., which has its principal place of business in Albany, New York, is a trade association that represents roughly twenty thousand establishments in the state of New York, the great majority of which sell cooked preparations containing meat, including poultry, dairy products, and fish to the public.
26. Plaintiff Greenbaum & Gilhooley’s is a highly-regarded restaurant located in Wappingers Falls, New York, that prepares and sells to the public meals containing meat, including poultry, dairy products, and fish. It is particularly known for its steak and seafood preparations. Greenbaum & Gilhooley’s is a member of Plaintiff Empire State Restaurant & Tavern Association, Inc.
27. Plaintiff BeDuCi is a highly-regarded restaurant doing business in the District of Columbia. It prepares and sells to the public meals containing meat, including poultry, dairy products, and fish. (Plaintiffs identified in ¶¶ 24-27 are referred to herein as "restaurant Plaintiffs".)
28. Plaintiffs Brevet Industries and Brevet, Inc. (collectively, "Brevet" or "the PVC Plaintiffs") are privately held California corporations, whose principal place of business is located in Irvine, California. Brevett manufactures medical products that contain polyvinyl chloride ("PVC"), including flexible plastic connectors for use in blood transfusions and other medical procedures.
29. Defendant U.S. Department of Health and Human Services ("HHS") is a department of the United States Government, and is the federal agency primarily responsible for the RoC program pursuant to P.L. 95-622. HHS headquarters are located in Washington, D.C.
30. Defendant Shalala is the current Secretary of the U.S. Department of Health and Human Services, and is the federal official to whom Congress gave responsibility and authority for implementing the RoC program pursuant to P.L. 95-622. Secretary Shalala makes the final new listing decisions for each edition of the RoC. The principal office of Defendant Shalala is located at HHS headquarters in Washington, D.C.
31. Defendant Kenneth Olden is Director of the National Institute of Environmental Health Sciences ("NIEHS"), one of the National Institutes of Health, and Director of the National Toxicology Program ("NTP"). Defendant Secretary Shalala has delegated to Dr.Olden and the NTP lead authority and responsibility for administering the RoC program under P.L. 95-622, and for making and forwarding recommendations to her regarding proposed listing decisions. Defendant Olden is also a member of the NTP Executive Committee, which is the last of the committees to review and vote on RoC listing proposals before they are sent to, considered, and acted upon by Defendant Olden. Defendant Olden has an office at HHS headquarters in Washington, D.C., as well as in North Carolina, from which he oversees the RoC program and consults with Defendant Shalala regarding the RoC program.
32. Defendants HHS, Shalala, and Olden are responsible for legal opinions and positions concerning the RoC program issued on their behalf by attorneys in the HHS Office of General Counsel.
33. Defendant George W. Lucier is Director of the NIEHS Environmental Toxicology Program and a Co-Editor-in-Chief of the NIEHS journal Environmental Health Perspectives. Defendant Olden has given Defendant Lucier substantial responsibility for administering the RoC program, including managing and advising the RoC review committees and advising Defendant Olden on matters concerning the program. Defendant Lucier represents Defendant Olden on the NTP Executive Committee.
JURISDICTION AND VENUE
34. This Court possesses federal question subject matter jurisdiction pursuant to 28 U.S.C. § 1331, and has authority to review this matter and grant the relief requested pursuant to the Declaratory Judgment Act, 28 U.S.C.§§ 2201-2202, and the Administrative Procedure Act, 5 U.S.C. §§ 701-706.
35. Venue is proper in this judicial district under 28 U.S.C. § 1391, because a substantial portion of the actions or omissions giving rise to the causes of action occurred or failed to occur at the headquarters of the U.S. Department of Health and Human Services, which is located in the District of Columbia.
36. The averments herein present a justiciable controversy within the meaning of Article III, section 2, clause 1 of the United States Constitution, and an actual controversy within the meaning of the Declaratory Judgement Act. The facts of the controversy have been fully developed, allowing entry of a judgment, and ordering of relief, that will resolve the controversy. The controversy exists between Plaintiffs and Defendants with regard to the position taken by HHS concerning the meaning and application of the RoC listing criteria to the agency’s proposal to list dioxin in the "known" category in the 9th RoC, and the manner in which Defendants have presented and evaluated the evidence allegedly supporting the dioxin listing proposal.
37. Defendants have taken a final agency action in the form of statements of position on the types of evidence that can be used to support listing of dioxin in the "known" category in the RoCs. By issuing a final position that the 1996 revisions to the RoC listing criteria allow a listing decision for the "known" category to be based on evidence other than sufficient evidence from studies in humans which indicates a causal relationship between exposure to dioxin and cancer, Defendants have taken final agency action that is judicially reviewable under the Administrative Procedure Act and the Declaratory Judgment Act. The position taken by Defendants on the meaning of the listing criteria/rules and their application to the proposed listing change for dioxin constitutes a deliberative determination of the agency’s position at the highest available level on a question of importance. Defendants have reiterated this position in numerous documents described herein, including Federal Register notices issued by Defendant Olden, and have given no indication that this position is subject to further consideration or possible modification.
38. Plaintiffs have a reasonable apprehension that Defendant Shalala will soon make a final decision to upgrade the dioxin listing in the RoC to the "known" category. In view of the unanimous action of the NTP Executive Committee, of which Defendant Olden is a member, in voting to recommend upgrading of the RoC dioxin listing to the "known" category, it should be assumed that Defendant Olden’s recommendation to Defendant Shalala will be consistent with that vote. It is highly likely that Defendant Shalala will ratify the recommendation on dioxin made by Defendant Olden. Additionally, Defendant Olden, as Defendant Shalala’s delegated representative for administering the RoC program, has signaled in the April 19, 1999 Federal Register notice described below that the agency will make its final decision in accordance with the erroneous and illegal position described above. The formal review process for the proposed listing, as provided for in the agency’s rules, has also been irrevocably tainted by the agency’s presentation of the evidence allegedly supporting the proposal in a manner that is arbitrary, capricious, and an abuse of discretion. The controversy is therefore sufficiently ripe for judicial review and declaratory judgment.
39. The type of exposure allegedly known to cause cancer in persons in the United States on which the proposed listing information for dioxin focuses is dietary exposure through consumption of certain foods. Defendants have proposed to disseminate to the public in the 9th RoC, in connection with a listing of dioxin as "known" to cause human cancer, the statement that "[m]ore than 90% of the dioxins found in humans in the general population are due to consumption of meat including poultry, dairy products, and fish . . . ." The relevant pages concerning human exposure from the "RC Draft Background Document For TCDD" ("DBD"), which would appear in the 9th RoC, are attached as Exhibit 4.
40. The DBD for the proposed 9th RoC lists "incineration of . . . hospital wastes" as one source of TCDD production. (Exh. 4 at ¶ 2.2). Such "hospital wastes" include products manufactured by the PVC Plaintiffs. The DBD also states, "Currently . . .atmospheric fall-out of CDD-laden particulates and gases appears to be the most predominant source of CDDs to the soil." (Exh. 4 at ¶ 2-3).
41. Plaintiffs are likely to suffer palpable, but unquantifiable, injury to their businesses and economic investments that is fairly traceable to the Defendants’ above actions. This likely injury would be averted by timely granting of the judicial relief sought. Specifically, such injury would occur, for the restaurant Plaintiffs, due to creation of a "food scare", resulting in reduced public consumption of meats including poultry, dairy products, and fish. These Plaintiffs would also face the practical necessity of expending effort and money attempting to locate and provide such foods which are not so contaminated. The PVC Plaintiffs also face serious economic injury in the form of lost sales due to product deselection, boycotts and federal, state, and/or local bans on PVC-containing products.
42. The threatened injuries to Plaintiffs are reasonably certain to occur following publication of the 9th RoC.
43. Plaintiffs are also intended consumers of the information disseminated in the RoCs.
44. Plaintiffs are within one or more of the zones of interest intended to be impacted by the RoCs.
NEED FOR REQUESTED RELIEF
45. Plaintiffs will have no way of knowing when Defendant Shalala actually makes a final listing decision for dioxin and what it is, nor when the 9th RoC will be published and made available to the public.
46. The RoCs are widely disseminated to the public by the federal government, and are used by environmental advocacy groups, including through information disseminated over the Internet, to influence public opinion against purchase and use or consumption of products containing dioxin.
47. Once a final listing decision for dioxin is published in the RoC and released to the public, it will not be possible to avert injury to Plaintiffs, since a multitude of copies of the 9th RoC will quickly be disseminated to the public, and the same information will be disseminated through the Internet. As a practical matter, it would not be possible to retrieve and rescind such information, and at that point, such injury would, as a practical matter, be irreparable.
48. All significant federal agency actions regarding dioxin receive widespread notice and attention in the press and on the Internet. Even preliminary actions receive such attention. For example, the 1997 action of the RoC Subcommittee in voting to upgrade dioxin to the "known" category, even though later reversed on re-review by the RoC Subcommittee, has been cited as the basis for the dangers of fish consumption and the need for regulatory action at the local level in resolutions passed recently by local government entities in San Francisco and Oakland, California. True and correct copies of those resolution are attached as Exhibits 5 and 6, respectively.
49. On September 14, 1999, the City Council of Berkeley, California, adopted a resolution calling for reduction of the use of PVC products as a means for eliminating dioxin from the environment. (Exh. 6A). The Resolution states, inter alia, "the incineration of chlorinated plastics, such as polyvinyl chloride (PVC) create dioxin, and PVC is the predominant source of organically bound chlorine in the medical waste stream." (Exh. 6A at p. 3, ¶ 20) (endnotes omitted). The Resolution specifically and repeatedly calls for the phasing out of the use of PVC plastics at City clinics and other health care institutions, with the goal of becoming PVC-free. (Exh. 6A at p. 6, ¶¶ C, D, E, F). This Resolution was based in part on the subsequently reversed, preliminary RoC Subcommittee finding noted in ¶ 48 above, that dioxin is a "known human carcinogen". (Exh. 6A, p. 2, ¶ 3 & n 3).
50. Plaintiffs have no other adequate remedy at law and have exhausted all reasonably available and appropriate avenues for administrative review and relief. The agency’s regulations do not specify a formal administrative review or appeal process for pursuing issues such as are involved in this Complaint.
51. Judicial resolution of this controversy at this time is in the interests of judicial and administrative economy, would not work a hardship on any party, and would further the public interest. In addition to misapplying the RoC listing criteria/rules to dioxin, Defendants have served formal notice that they intend to apply the incorrect "interpretation" of their criteria/rules to other substances both now and in the future. Substances other than dioxin currently under review and proposed for the "known" human carcinogen category include substances of wide concern, such as alcoholic beverages, the breast cancer drug tamoxifen, 1,3-butadiene, crystalline silica, nickel compounds, and ethylene oxide . Draft Background Documents summarizing the evidence for many of these proposed listings contain evaluations of evidence other than evidence from studies in humans.
52. No purpose would be served by delaying judicial review.
FACTS GIVING RISE TO THE CAUSES OF ACTION
53. On July 11, 1997, Defendants Kenneth Olden, HHS, and NTP issued a Federal Register notice announcing the agency’s intent to review dioxin for upgrading from the "reasonably anticipated" to the "known" category in the 9th Report on Carcinogens, and invited public comments. A copy of this Federal Register notice, 62 Fed.Reg. 37272-73, is attached as Exhibit 7.
54. By letter dated August 22, 1997, in response to the above Federal Register notice on the listing nominations, Plaintiff Tozzi submitted comments on the proposed change in the dioxin listing, asserting that there was not "sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship", as required by the September 26, 1996 revised listing criteria for the "known human carcinogen" category. He also called attention to the 1997 IARC review of dioxin, which concluded that the evidence from studies in humans was not "sufficient", but rather was "limited". Plaintiff Tozzi further noted that and that the agency had traditionally relied on such IARC evaluations with regard to sufficiency or insufficiency of the evidence from studies in humans. A true and correct copy of that comment letter is attached as Exhibit 8.
55. Sometime prior to September 30, 1997, NTP’s RG1 and RG2 RoC review committees reviewed the dioxin listing, and both committees voted to upgrade the listing from "reasonably anticipated" to "known".
56. On September 30, 1997, NTP issued an "RC Draft Background Document for TCDD" ("DBD") reflecting the basis for the RG1 and RG2 votes. This document contained the proposed revised text for the proposed RoC upgrade of the dioxin listing. The text of the DBD proposed to change the listing of dioxin to "known to be a human carcinogen" based on three types of evidence: (1) "human studies"; (2) "studies in experimental animals"; and (3) evidence of "the mechanism of induction of animal and human tissue biochemical and toxicological responses". The DBD was made available to the public prior to, and at, the October 31, 1997 RoC Subcommittee review meeting at which the proposed change in the dioxin classification to "known" was considered. A true and correct copy of the pages of the DBD summarizing the scientific evidence proposed for use in the RoC is attached as Exhibit 9.
57. The DBD summary of the supporting evidence also relied substantially on the1997 IARC review of dioxin. The pertinent portions of the IARC monograph (Monograph 69) were included in the DBD as an appendix, with the exception of the "Summary Of Final Evaluations" at page 631 of the monograph.
58. The DBD contained no finding that there was sufficient evidence of carcinogenicity from studies in humans indicating a causal relationship between exposure to dioxin and human cancer.
59. The DBD proposed listing summary, instead of finding a "causal relationship", referred only to evidence supposedly indicating an "association". It is recognized among epidemiologists and other health scientists who review evidence from studies in humans that an "association" is not a "causal relationship", and is not sufficient to indicate a causal relationship. Strength of "association" is only one factor commonly evaluated in attempting to determine whether there is sufficient evidence of a causal relationship.
60. The DBD summary also stated that in the 1997 IARC review and monograph, which was attached to the DBD, "[in] the highly exposed industrial sub-cohorts, a causal relationship between TCDD exposure and mortality from all cancers combined was noted, but there was less strong evidence for cancers of any particular site." At p. RC-1. The DBD summary did not provide a reference to the specific page or portion of the IARC monograph allegedly containing such a finding, and it appears that the only statement in the IARC monograph containing any language resembling such an assertion is at p. 193, wherein it is stated that two of the four industrial exposure study groups -- ones primarily relied on by HHS/NTP in its DBD summary and overall evaluation, the BASF accident cohort and the Boehringer-Ingelheim cohort -- "together provide dose-response evidence supporting a causal relationship . . . ."
61. Additionally, the DBD stated, in a section following the summary entitled "Human Studies": "In its summary of the epidemiological evidence from the most highly exposed populations, the IARC Working Group identified a causal association between TCDD exposure and all cancers combined . . . .", citing the IARC monograph at pp. 192-93.
62. Evidence of dose response is only one of several aspects of evidence from studies in humans commonly assessed by the scientific community in evaluating whether the evidence from studies in humans as a whole supports a causal relationship. Other aspects of the human evidence playing a role determinations of causality include (1) the potential for results being due to chance, bias, or confounding; (2) the strength of any observed associations between exposure and increased incidence of cancer(s); (3) consistency of findings; (4) specificity of the linkage between exposure and a particular type or site of disease; and (5) "temporality" -- meaning whether it is clear that the disease occurred after, and sufficiently after, the exposure to be attributed to the exposure.
63. In its summary analysis of the human carcinogenicity data, its Evaluation, its Overall Evaluation, and its "Summary Of Final Evaluations" (pp. 336-38, 342-43, and 631 of the monograph, respectively), IARC determined that the human evidence was not "sufficient" to establish a causal relationship; but rather, was "limited", and classified dioxin as carcinogenic to humans by relying on animal and other evidence to compensate for, and buttress, the "limited" human evidence. In finding that the human evidence was not "sufficient", IARC noted the lack of consistency among the human study findings, the weak associations detected in most of those studies with positive findings, the inability to exclude confounding exposures of chemical plant workers to other potentially carcinogenic chemicals as explaining positive results, and the lack of specificity regarding cancer sites.
64. Throughout the various RoC’s to date, HHS/NTP has uniformly conformed its terminology for degrees of evidence to those of IARC. That is, HHS/NTP’s term "sufficient" has been considered equivalent to IARC’s "sufficient"; and HHS/NTP’s term "limited" has been considered equivalent to IARC’s "limited". In the RoC’s to date, IARC findings of "sufficient" human evidence have been used by HHS/NTP to place substances in the "known" category; and IARC findings of "limited" human evidence, have been used to place substances in the "reasonably anticipated" category. The HHS/NTP listing criteria, both prior to and following the 1996 revisions, have used the term "sufficient" for the "known" category, and "limited" for the "reasonably anticipated" category in describing the degrees of human evidence required to support listings in those categories.
65. To the extent that the above-described statements in the DBD were intended to indicate that IARC had found that there was sufficient evidence from studies in humans indicating a causal relationship between dioxin exposure and human cancer, such statements were and are manifestly untrue and intentionally misleading.
66. The summary of the evidence in the DBD also stated that findings contained in an "in press" publication by Bertazzi et al. "were not considered in the IARC evaluation and further strengthen the association between dioxin-exposure and human cancer." In context, this DBD statement appears intended to support the basic proposed conclusion that the dioxin listing upgrade would be based on findings regarding "all cancers combined" or "overall cancer mortality".
67. The essential findings of the "in press" study by Bertazzi et al. were in fact considered by IARC as presented in a shorter, 1996 version of the 1997 "in press"article. The 1996 findings by Bertazzi et al. are discussed at pp. 161-62 of the IARC monograph, and in Table 33 at pp. 146-47, and are cited in the IARC monograph at p. 531 as "Bertazzi, P.A., Pesatori, A.C. & Landi, M.T. (1996) Cancer mortality, 1976-1991, in the population exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin. Organohalogen compounds, 30, 294-296."
68. This inaccurate and misleading statement in the DBD regarding the Bertazzi et al. findings was called to the attention of NTP in the comments by Plaintiff Tozzi dated November 26, 1997. A true and correct copy of that November 26, 1997 letter is attached as Exhibit 10. This was also called to the attention of NTP by Raymond S. Greenberg, MD, PhD, Provost of the Medical University of South Carolina, who was an invited observer and participant in the IARC deliberations, in written comments and in his oral comments at the public RoC Subcommittee review meetings on October 31, 1997 and December 2, 1998. Nevertheless, after Defendant Olden stated to the public that there would be a re-review, NTP re-issued its DBD prior to the December 2, 1998 public RoC Subcommittee review without changing the statement.
69. In addition, neither the 1996 or 1997 publications by Bertazzi et al. appear to support the agency’s DBD evaluation, since the publications did not find any significant increase in all cancers combined, and the authors found the human evidence to be "limited" and only indicative of a plausible association (as opposed to a causal relationship).
70. On October 31, 1997, the RoC Subcommittee conducted a public review of the listings proposed for the 9th Report on Carcinogens. At that meeting, Plaintiff Tozzi presented both written and oral public comments in which he asserted that the DBD, and the scientific literature in general, did not contain findings sufficient to satisfy the criteria for the "known" category, and that the proposal to upgrade and the presentation of evidence in the DBD were at odds with the listing criteria/rules in relying on evidence from animal and other non-human experimental studies to compensate for lack of sufficient evidence from studies in humans indicating a causal relationship. A true and correct copy of Plaintiff Tozzi’s written comments at that meeting is attached as Exhibit 11.
71. At the October 31, 1997 public meeting, the RoC Subcommittee voted 4 to 3, with one abstention, to support the upgrade of TCDD to the "known" category, relying on the scientific evidence as presented in the September 30, 1997 DBD.
72. By letter dated November 26, 1997, Plaintiff Tozzi wrote to Defendant Olden to call to his attention "serious legal, ethical, scientific, and administrative flaws" that were evident in the RoC Subcommittee review meeting on October 31, 1997. Among those flaws, he pointed out, was "departure from the Report on Carcinogens listing criteria as revised by Defendant Shalala on September 12, 1996 . . . ." More specifically, his letter pointed out that all three reviews to date -- RG1, RG2, and the RoC Subcommittee -- were based on a DBD that did not contain findings consistent with the listing criteria for "known", and that the proposed change in listing was being supported explicitly with evidence which was not permitted, namely evidence from animal and other studies that were not studies in humans. A true and correct copy of this letter, also referenced above in paragraph 61, is attached as Exhibit 10.
73. In the same November 26, 1997 letter, Plaintiff Tozzi also called attention to the inaccurate statements in the DBD regarding (1) the 1997 IARC findings, and (2) IARC’s alleged lack of consideration of the Bertazzi et al. findings, and (3) the findings of Bertazzi et al. as alleged to support the listing proposal.
74. By letter dated January 30, 1998, Defendant Olden replied to Plaintiff Tozzi’s November 26, 1997 letter, informing him that he had decided to order a re-review dioxin in 1998 because he felt that the recent review of the dioxin listing proposal might not have been adequate. In stating this, however, Defendant Olden also stated that he wished to emphasize that he "believed the criteria were appropriately applied to the evaluation of all available data for dioxin . . . ." A true and correct copy of this letter is attached as Exhibit 12.
75. By letter dated January 31, 1998, Plaintiff Tozzi wrote to Defendant Olden to summarize a meeting that took place on January 6, 1998 between MBS staff and NTP staff. At that meeting, as reflected in the letter, Plaintiff Tozzi, through his MBS staff and with supporting documentation, once again carefully went over his position that HHS and NTP were violating their listing rules by proposing to base a dioxin listing upgrade to the "known" category on evidence other than sufficient evidence of carcinogenicity from studies in humans indicating a causal relationship. The letter also reflects that NTP staff took the position that their listing criteria allowed them to base such a listing on any type of evidence they considered relevant, even if it were not from studies in humans. In this letter, Plaintiff Tozzi requested that, as a result of the HHS/NTP views expressed at that meeting, Defendant Olden again review the matter as Director of the NTP, and inform Plaintiff Tozzi whether plaintiff’s understanding of the official NTP position on application of their listing criteria was correct. Plaintiff Tozzi also requested that the matter be brought before Defendant Shalala and resolved expeditiously, especially since the issue might affect not only the dioxin listing proposal, but many other current and future listing proposals. Attached to Plaintiff Tozzi’s letter were drafts of guidance memoranda that Plaintiff Tozzi suggested be issued by Defendant Olden to the NTP staff regarding correct application of the "known" listing criteria in general, and their application to dioxin in particular. In closing, Plaintiff Tozzi asked to be advised of any action taken on this matter. A true and correct copy of this letter is attached as Exhibit 13.
76. On April 8, 1998, Defendant Olden approved, and on April 15 published, a Federal Register notice announcing that there would be a re-review of dioxin by the RoC Subcommittee in December 1998 (63 Fed.Reg. 18435). The notice invited public comment prior to the re-review, and stated: "The NTP wants to insure that all relevant information for TCDD pertaining to its epidemiology and the mechanism of tumor formation in humans and laboratory animals is adequately considered and solicits additional relevant information in support of or against the nomination to list TCDD as a Known to be Human Carcinogen in the Report on Carcinogens, Ninth Edition." A true and correct copy of this notice is attached as Exhibit 14.
77. By letter dated June 12, 1998, Plaintiff Tozzi again submitted comments to NTP on the proposed change in listing of dioxin to the "known" category. His comments pointed out again that the evidence relied on to date by NTP for the proposal was at odds with the formal listing criteria for the "known" category. A true and correct copy of these comments is attached as Exhibit 15.
78. By letter dated July 31, 1998, Plaintiff Tozzi wrote to Defendant Olden to comment that there was another "fundamental flaw" in the listing proposal for dioxin. This fundamental flaw was that all of the human evidence cited in support of the listing proposal concerned chemical plant workers (or, in one case, residents exposed to matter that emanated from an explosion in a nearby chemical plant) who were highly exposed to combinations of chemicals which only contained dioxin as an impurity, and some of those chemicals had previously been identified as possible human carcinogens. These comments also observed that NTP was proposing to move dioxin to the "known" category with an explanation that the primary source of human exposures to dioxin in the United States occurred through the diet. No other source of exposure to a significant population within the United States was identified in the DBD. Plaintiff Tozzi asserted in these comments that the evidence cited in the DBD did not support listing of dioxin, and the evidence, even if it supported a listing in the "known" category, only supported listing of the types of exposures in the studies in humans principally relied on in the DBD. A true and correct copy of these comments is attached as Exhibit 16.
79. On August 24, 1998, Defendant Olden wrote to Plaintiff Tozzi in response to the above comments. Defendant Olden stated that the NTP review groups had appreciated the point raised by Plaintiff Tozzi and had chosen to focus solely on dioxin rather than the actual mixed exposures, and that he would make Plaintiff Tozzi’s comments available to the RoC Subcommittee members prior to their deliberations on the TCDD nomination on December 2, 1998. A true and correct copy of this letter from Defendant Olden is attached as Exhibit 17.
80. Despite the above statements by Defendant Olden, there was no discussion of the above exposure characterization issue either in the DBD as issued in both 1997 and 1998, or in the Supplement to the DBD issued in November 1998.
81. To the best of Plaintiffs’ knowledge, the RG1 and RG2 committees did not conduct a "re-view" of the dioxin listing proposal and vote a second time on the proposed upgrade.
82. By letter dated September 21, 1998, Plaintiff Tozzi wrote to Defendant Shalala and U.S. EPA Administrator Carol Browner advising them that there appeared to be a serious inconsistency between the HHS/NTP criteria/rules for listing a substance as a "known human carcinogen" and similar criteria/rules proposed by EPA. The inconsistency derived from the fact that the HHS/NTP criteria/rules required that a "known" classification be based on sufficient evidence of carcinogenicity from studies in humans indicating a causal relationship, while the criteria/rules proposed by EPA would allow such a classification even if the human evidence were "limited", provided that EPA believed that other evidence not from studies in humans was sufficient to compensate for the "limited" human evidence. A true and correct copy of this letter is attached as Exhibit 18.
83. By notice in the Federal Register on October 26, 1998, Defendant Olden announced that the re-review of dioxin by the RoC Subcommittee would take place at a public meeting on December 2 and 3, 1998, together with the reviews of proposed listings for 10 other substances (63 Fed.Reg. 57132-33). The notice also contained this broad statement concerning the listing criteria: "The major change in the RoC which occurred as a result of the  criteria revision was to include consideration of all relevant information, including mechanistic data, in the decision to list in or delist from future volumes." A true and correct copy of this notice is attached as Exhibit 19.
84. By letter dated November 2, 1998, Defendant Olden replied, on behalf of Defendant Shalala, to Plaintiff Tozzi’s September 21 letter to Defendant Shalala and Administrator Browner. In his letter, Defendant Olden stated that a "key point" in the 1996 revision of the HHS/NTP RoC listing criteria/rules "is the consideration of all relevant scientific data in making decisions regarding listing." He went on to state that it was his understanding that his agency’s listing criteria "are in fact similar to the proposed EPA Guidelines, which call for a rather broad ‘weight of the evidence’ approach in the consideration of similar types of relevant information." He also stated that he believed that the HHS listing criteria were consistent with the listing criteria for the highest category used by IARC. A true and correct copy of this letter is attached as Exhibit 20.
85. Shortly after issuance of the above October 26, 1998 Federal Register notice, the NTP made available to the public DBDs for all of the substances to be reviewed at the December 2-3 public RoC Subcommittee meeting. The proposed listing summary in the DBD for dioxin was exactly the same as that made available to the public prior to the first RoC Subcommittee review of dioxin on October 31, 1997. At the same time, HHS/NTP issued a "Supplement" to the 1997/1998 DBD. The Supplement consisted of an "Introduction", "Epidemiology Updates" for 1997-98, and supplemental citations to studies in humans, animal studies, and in vitro studies. The Supplement did not state that it was making any modification to the agency’s analysis of the evidence contained in the 1997 DBD, and the Introduction stated that the 1997 DBD "relied primarily on the IARC monograph on TCDD...." A true and correct copy of this Supplement is attached as Exhibit 21. 86. The Supplement to the DBD cited numerous reports of animal in vivo experiments, and numerous reports of in vitro experiments.
87. On November 20, 1998, Charles J. Fromm, an attorney with Multinational Legal Services, P.C., which provides legal services to Multinational Business Services, Inc., wrote to Robert Lanman, NIH Branch Chief in the HHS Office of General Counsel, on behalf of Plaintiff Tozzi and Multinational Business Services to inform him that the NTP review of dioxin was proceeding in violation of the listing criteria for the "known" category, and requesting that the HHS Office of General Counsel intervene prior to the December 2-3 RoC Subcommittee meeting by reviewing the issue and communicating its findings to Defendant Olden and NIEHS. Mr. Fromm’s letter referenced, and enclosed, Plaintiff Tozzi’s September 21, 1998 letter to Defendant Shalala and EPA Administrator Browner, and Defendant Olden’s November 2, 1998 reply on behalf of Defendant Shalala. The letter also indicated that if the issue could not be resolved satisfactorily by the Office of General Counsel, it might be necessary to pursue a remedy through litigation, and Mr. Fromm offered to meet with Mr. Lanman to discuss the situation. Defendant Olden was designated to receive, and did receive, a copy of this November 20 letter to Mr. Lanman. A true and correct copy of this letter is attached as Exhibit 22.
88. The RoC Subcommittee re-reviewed dioxin on December 2, 1998. Plaintiff Tozzi presented written and oral comments at this meeting, in which he pointed out that not a single word had been changed in the DBD for dioxin, despite Defendant Olden’s commitment to a "re-review", and that the DBD still contained no finding of sufficient evidence from studies in humans indicating a causal relationship between exposure to dioxin and cancer, but rather, relied on "a hodgepodge of human, animal, and other data." At that meeting, the RoC Subcommittee voted 7-5, with one abstention, against the proposal to upgrade dioxin to the "known" category. A true and correct copy of Plaintiff Tozzi’s written comments is attached as Exhibit 23.
89. By letter dated January 6, 1999, Patricia Kvochak an attorney in the HHS Office of General Counsel, replied to Mr. Fromm on behalf of Mr. Lanman. On the one hand, the letter assured Mr. Fromm that "no substance is listed as known to be human carcinogen unless there is sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship between exposure to the substance and human cancer." On the other hand, her letter stated that "conclusions regarding carcinogenicity in . . . humans, whether known or reasonably anticipated carcinogens, are based on scientific judgment, with consideration given to all relevant information." Her letter also took the position that Plaintiff Tozzi and Mr. Fromm were mistaken in reading the September 26, 1996 Federal Register notice of the revised criteria to state that the paragraph beginning "Conclusions regarding carcinogenicity in humans . . . are based on scientific judgment, with consideration given to all relevant data" applied only to the "reasonably anticipated" listing criteria, and that such paragraph also applied to the listing criteria for the "known" category. Defendant Olden was designated to receive, and did receive, a copy of this letter. A true and correct copy of this letter is attached as Exhibit 24.
90. On January 19, 1999, Mr. Fromm responded to Ms. Kvochak’s January 6, 1999 letter. He expressed agreement with the statement in Ms. Kvochak’s letter that listings in the "known" category must be based on sufficient evidence from studies in humans indicating a causal relationship between exposure to the specific substance and cancer. He disagreed, however, with her statement that the paragraph in the 1996 Federal Register notice beginning "Conclusions regarding carcinogenicity in humans . . . ." applied to the "known" category. He also again pointed out that the DBD for dioxin did not contain any evidentiary findings consistent with the criteria for listing in the "known" category, and that HHS was proceeding with the proposed listing for dioxin contrary to its own rules. He again requested that the HHS Office of General Counsel intervene to resolve the controversy. Defendant Olden was designated to receive, and did receive, a copy of this letter. A true and correct copy of this letter is attached as Exhibit 25.
91. On February 3, 1999, Mr. Fromm telephoned Ms. Kvochak to ask whether the HHS Office of General Counsel would take further action as requested in his January 19 letter or otherwise respond. Ms. Kvochak declined to commit to any further action, by way of written response or otherwise, and indicated that the agency’s position remained unchanged. As of the date of filing of this Complaint, neither Plaintiff Tozzi nor Mr. Fromm has received any communication from any office or person within HHS indicating further action, or the possibility of further action, to resolve this controversy.
92. On February 12, 1999, Mr. Fromm wrote to the Chair of the NTP Executive Committee, with copies to all Executive Committee members and alternates, asserting that the position taken by Ms. Kvochak in her January 6, 1999 opinion letter -- namely, that NTP can rely on animal and mechanism of action data to support a known human carcinogen listing -- was "demonstrably false", based on overwhelming documentary evidence regarding the meaning of the criteria, and that NIH legal counsel were continuing to fail to respond in any adequate manner to the evidence presented. Defendant Olden was designated to receive, and did receive, a copy of this letter as a member of the NTP Executive Committee. A true and correct copy of this letter is attached as Exhibit 26.
93. On February 24, 1999, the NTP Executive Committee, the fourth and last review committee in the RoC listing process, met to consider the dioxin listing nomination and the scientific evidence presented in the DBD for dioxin as well as the listing proposals for other substances, and voted unanimously to upgrade dioxin to the "known" category based on that scientific evidence. Because the NTP Executive Committee voted unanimously, and because Defendant Olden was a voting member of the committee, that action by the NTP Executive Committee effectively indicates that Defendant Olden will approve the dioxin listing proposal and recommend to Defendant Shalala that she approve the proposed listing change.
94. On April 2, 1999, HHS/NTP and Defendant Olden issued a Federal Register notice concerning substances nominated for review for the Tenth Edition of the RoC. (63 Fed.Reg. 15983-84) That notice contained a section entitled "Clarification of the Criteria". That "Clarification" was contrary to the plain wording of the listing criteria/rules, and constituted a post hoc effort to state an agency interpretation of its rules in anticipation of litigation challenging its listing of dioxin in the "known" category. The "Clarification" is contrary to the plain wording of the criteria/rules for the "known" category in implying that (1) the human evidence of carcinogenicity does not need to be "sufficient", (2) the human evidence does not need to be sufficient to indicate a causal relationship, (2) "human" evidence need not come from studies "in" humans, but, rather, can come from data derived "from" human tissue or cells that were not taken from complete humans who were exposed while alive, and (3) substantial reliance can be placed on evidence from animals or in vitro cell cultures or samples. A true and correct copy of this Federal Register notice is attached as Exhibit 27.
95. The April 2, 1999 Federal Register notice described above is further confirmation that Defendants HHS, Shalala, and Olden have taken a final agency position on the meaning and application of the criteria/rules for listing in the "known" category that will be applied to dioxin.
96. On April 19, 1999, HHS/NTP and Defendant Olden issued another Federal Register notice related to the above April 2 notice that (1) extended the public comment period for the nominations for the Tenth Edition of the RoC, and (2) expanded the "Clarification" of the "known" listing criteria/rules contained in the April 2 notice. The April 19 notice added to the previous "Clarification" a second paragraph stating that the final "descriptive" paragraph in the RoC listing criteria/rules, which is under the heading of "Reasonably Anticipated to be Human Carcinogens" (as reprinted in the April 2, 1999, notice), "has [since the revised criteria were published] applied to both the ‘known to be human carcinogen’ and the ‘reasonably anticipated to be human carcinogen’ categories and will continue to apply." A true and correct copy of this Federal Register notice is attached as Exhibit 28.
97. The statement in the April 19, 1999 Federal Register notice expanding the April 2 "Clarification" further confirms that it is the agency’s final position that it may employ "all relevant information", regardless of whether it is sufficient evidence of carcinogenicity from studies in humans, including evidence from animal studies, in vitro studies, and even "chemical structure", in order to conclude that dioxin can and should be listed in the "known" category.
98. The April 19, 1999 Federal Register notice also confirms that this final agency position will be applied to all substances other than dioxin currently under review for listing, and to all future listing proposals and determinations.
99. The May 1999 issue of Environmental Health Perspectives, the "Journal of the National Institute of Environmental Health Sciences", contains an editorial by Defendant Lucier as Co-Editor-in-Chief in which he states that NTP has been "explicit in . . . statements that mechanistic data can be used to upgrade the results of inconclusive epidemiology data as well as to downgrade." This also is an official agency statement on the meaning of the "known"category listing criteria/rules because, since there are only two categories, "known" and "reasonably anticipated", any "upgrade" must be a change in listing from the "reasonably anticipated" category to the "known" category, as in the case of the proposed dioxin listing upgrade.
100. The statements of agency position in the April 19, 1999 Federal Register notice and the editorial in the May 1999 issue of Environmental Health Perspectives on the meaning the agency has given to the "known" category criteria/rules are inaccurate and misleading.
101. Defendant Olden is expected to make his listing recommendation on dioxin to Defendant Shalala, and Defendant Shalala is expected formally to finalize a listing decisions for dioxin sometime between November 1999 and May 2000.
102. All of the RoC review committee votes on the listing proposal for dioxin noted above, with the exception of the action by the NTP Executive Committee, have been stated in various Federal Register notices.
FIRST CAUSE OF ACTION:
103. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.
104. Defendants U.S. Department of Health and Human Services and Shalala have, through their delegated representatives Defendants Olden and Lucier, and attorneys Lanman and Kvochak, taken a final agency position that the agency will not comply with the plain language of its listing criteria/rules in determining whether to list dioxin as a "known human carcinogen" in the 9th RoC, and this final agency position threatens to cause Plaintiffs palpable injury through the consequences of listing dioxin as a "known" human carcinogen. Specifically, Defendants have taken the position that they will consider and rely on evidence that is not "sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship", particularly evidence from animal and other non-human experiments, in making the RoC listing decision for dioxin.
105. Defendants’ position that they will not comply with their duly-promulgated listing criteria/rules in making a listing determination for dioxin in the 9th RoC is a final agency action that is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law, is in excess of Defendants’ statutory authority, and is taken without observance of procedure required by law.
106. Preliminary and permanent injunctive relief are appropriate because Plaintiffs would be irreparably harmed by wide public dissemination of the listing action on dioxin; there is a strong likelihood that Plaintiffs would prevail on the merits; granting of such relief would not substantially injure other parties; and such relief is in the public interest, particularly since Defendants have now stated that their new "interpretation" of the listing criteria for the "known" category will be applied to other substances in the future.
SECOND CAUSE OF ACTION:
107. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.
108. Defendants U.S. Department of Health and Human Services and Shalala, through their delegated representatives Defendants Olden and Lucier, have presented the evidence allegedly supporting a listing of dioxin as a "known" human carcinogen in a manner which is knowingly inaccurate and misleading, and therefore arbitrary, capricious, and an abuse of discretion. As set out previously in this Complaint, such presentations include the knowingly inaccurate and misleading assertion that the 1997 IARC review found a causal relationship in the human studies, and the knowingly inaccurate statement that the Bertazzi et al. findings were not considered by IARC in 1997 when IARC determined that the human evidence was not "sufficient" to establish a causal relationship.
THIRD CAUSE OF ACTION:
109. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.
110. Defendants U.S. Department of Health and Human Services and Shalala, through their delegated representatives Defendants Olden and Lucier, have based the dioxin listing proposal primarily on studies in humans in which chemical plant workers were not studied for the consequences of their exposure to dioxin, but for the consequences of their exposure to combinations of chemicals which included dioxin as an impurity. Such exposures occurred through inhalation and/or dermal absorption rather than through consumption of meat, including poultry, dairy products, and fish-- the types of exposures that Defendants asserts as the basis for the currently proposed listing of dioxin in the "known" category in the 9th RoC.
111. The dioxin listing text, if approved and published, would state that ordinary human dietary exposures to meats including poultry, dairy products, and fish are known to be cause cancer. Dissemination of such information to the public would be arbitrary, capricious, and an abuse of discretion, and would cause Plaintiffs palpable injury.
FOURTH CAUSE OF ACTION:
112. Plaintiffs re-allege and incorporate by reference herein all of the statements, allegations, and claims set forth in the preceding paragraphs of this Complaint.
113. The principal evidence presented by the agency to its RoC review committees in support of the dioxin listing proposal, and considered by the agency itself, falls far short of providing a sufficient basis for listing dioxin in the "known" category.
114. Considering the averments of this Complaint and the record as a whole, Defendants’ threatened action to list dioxin as "known to be a human carcinogen" and their positions and statements in support of the proposal are arbitrary, capricious, an abuse of discretion, not in accordance with law, and without observance of procedure required by law.
PRAYER FOR RELIEF
For all of the foregoing reasons, and based on all of the foregoing statements, allegations, and claims, Plaintiffs respectfully request that this Court grant the following forms of relief:
1. A judicial declaration that Defendants’ position to date with regard to the type and degree of evidence required for listing dioxin as a "known human carcinogen" in the RoCs is not in accordance with the law as set forth in the HHS criteria/rules for such listing decisions;
2. A preliminary injunction prohibiting Defendants from disseminating any further information concerning a decision regarding a change in the listing of dioxin while this suit is pending;
3. A permanent injunction prohibiting Defendants from making and publishing any change in the listing of dioxin in the RoCs unless they comply with the agency’s listing criteria/rules throughout the complete listing review process, including preparation of a new DBD for dioxin that demonstrates compliance with the agency’s listing rules and removes the inaccurate and misleading statements described in this Complaint from explanations of the evidence supporting a proposed listing decision.
Dated: November 1, 1999 Respectfully submitted,