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No. 00-5364
(C. A. No. 99-1170)

JIM TOZZI, et al. Appellants,


Appellees (1) respectfully move for summary affirmance of the Honorable Emmet G. Sullivan's September 30, 2000, Memorandurn Opinion and Order granting their Motion to Dismiss and for Summary Judgment. See Memorandum Opinion (attached as Exhibit A), Summary Disposition is appropriate in this case because the "merits of this appeal are so clear as to make summary affirmance proper." Taxpayer's Watchdog, Inc. v. Stanley, 819 F.2d 294, 297 (D.C. Cir. 1987); Walker v. Washington, 627 F.2d 542. 545 (D.C. Cir. 1980); accord, Ambach v.Bell, F.2d 974, 979 (D.C. Cir. 1982) (per curiam). In addition, appellants' motion for an injunction pending appeal should be denied.

In their motion for injunction pending appeal, appellants fail to establish any grounds upon which this Court should grant injunctive relief pending appeal. Ultimately, appellants' motion for injunctive relief pending appeal fails for the same reasons that their motion for injunctive relief failed below. Appellants cannot show that they are likely to succeed on the merits of this appeal, or that they will suffer irreparable harm. As set forth fully in the District Court's well-reasoned Memorandum Opinion, and reinforced in its order denying injunctive relief pending appeal, appellants are not entitled to the relief they seek. At bottom, appellees' motion for summary affirmance should be granted, and appellants' motion for injunction pending appeal should be denied.


Appellants initiated this action under the Administrative Procedure Act ("APA") challenging the Department of Health and Human Services ("HHS") and the National Institute of Environmental Health Sciences ("NIEHS") decision to upgrade the chemical tetrachlorodibenzo-p-dioxin ("dioxin" or "TCDD") from the "reasonably anticipated to be a human carcinogen" category ("reasonably anticipated category") to the "known to be a human carcinogen" category ("known category") in the 9th Report on Carcinogens ("RoC"). Appellants challenged appellees' criteria for listing a substance in the known category, and appellees' decision to place dioxin in that category. They sought to enjoin the publication of dioxin in the known category in the 9th RoC. In December 1999, appellees moved to dismiss and for summary judgment.

By Memorandum Opinion and Order dated September 30, 2000, the District Court granted the appellees' motion to dismiss in part and granted appellees' motion for summary judgment. The District Court concluded that only one of the appellants had standing and dismissed the complaint with respect to the other appellants.(2) It also found eminently reasonable appellees' interpretation of the revised criteria for listing a substance in either the known or reasonably anticipated category and their conclusion that dioxin should be listed in the known category. See Exhibit A at II.

On October 6, 2000, appellants moved for an injunction pending appeal which the District Court denied on November 14 Appellants noted their appeal on October 13 and moved for injunction pending appeal in this Court on November 17.


A. The District Court's Decision Should Be Summarily Affirmed.
1. Appellees' decision was not arbitrary and Capricious.

In actions under the Administrative Procedure Act, 5 U.S. C. 701 et seq., a party challenging agency action bears a heavy burden, because the "arbitrary and capricious standard of review requires the court to presume the validity of the agency action." See American Horse Protection Ass'n v. Yeutter, 917 F.2d 594, 596 (D.C. Cir. 1990). Under that narrow standard of review, the Court is not authorized to conduct a de novo review of the facts or substitute its judgment for that of the agency. See Camp v. Pitts, 411 U.S. 138, 142 (1973).

The District Court properly concluded that it "must give deference to the agency in interpreting its own criteria." See Exhibit A at 10, citing Thomas Jefferson University v. Shalala 512 U.S. 504, 512 (1994). Relying on a decision of this Court, the District Court found that "an agency's interpretation of their own listing criteria 'is controlling unless it is plainly erroneous or inconsistent with the regulation."' Id., quoting Wyoming v. Outdoor Council v. United States Forest Service, 165 F.3d 43, 52 (D.C. Cir. 1999). It further found that when, as here, "the agency itself has drafted the rule or regulation at issue, the Court's review is "more deferential than afforded under Chevron." Id. quoting National Medical Center v. Shalala, 43 F.3d 691, 697 (D. C. Cir. 1997), and citing Rollins v. U. S. Environmental Protection Agency, 937 F. 2d 649, 652 (D.C. Cir. 1991).

Applying this deferential standard of review, the District Court correctly concluded that the appellee's interpretation of their criteria to permit consideration of both mechanistic and animal data in deciding to place a substance in either the known or reasonably anticipated category was "eminently reasonable." Id. at 11. In reaching this conclusion, the District Court referred to the final paragraph of the criteria which states that: "conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information." The District Court also pointed out that "the presentation of the proposed change in the Federal Register makes it clear that the proposed change is intended to apply to the criteria for both the 'known' and 'reasonably anticipated' categories." Id. In other words, the proposed change in the Federal Register demonstrated that mechanistic data would be considered in determining whether to place a substance in the known or reasonably anticipated categories.

The District Court also found that the agency's decision to place dioxin in the known category was eminently reasonable. Id In this regard, the District Court correctly concluded that "a court must review scientific judgments 'not as the chemist, biologist, or statistician that [it is] qualified neither by training nor experience to be, but as a reviewing court exercising [its] narrowly defined duty of holding agencies to certain minimal standards of rationality."' Id at 11-12, citing Troy Corp. v. Browner, 120 F.3d 277, 283 (D.C. Cir. 1997). Applying this standard, the District Court properly found that the appellees' "reliance on the studies involved and interpretation of [their] own regulations survives [appellants'] allegations." Id. at 12.

In their motion, appellants lodge four attacks on the District Court's Opinion. First, they argue that the precedent requiring the court to defer to an agency's interpretation of its own criteria is inapplicable here because there is contemporaneous evidence suggesting that the appellee's initial position regarding the listing of dioxin was contrary to that advanced during litigation. See Appellants' Motion for Injunction Pending Appeal ("App. Motion") at 7-10. Second, appellants also question the court's finding that the appellees' interpretation of the revised criteria for the 9th RoC was reasonable. Id at 11- 12. In particular, appellants challenge the court's conclusion that the final descriptive paragraph of the revised criteria was intended to modify both the "known" and "reasonably anticipated" listing categories. Id. Third, appellants dispute the court's conclusion that the "presentation of the proposed change in the Federal Register" supports appellees' position. Id at 13. Fourth, appellants claim that appellees revised the RoC listing criteria in 1996 to permit, for the first time, consideration of mechanistic data for listing a substance in the known category and that appellees failed to provide notice and a reasoned explanation for this change. Id. at 8, 13-14. As discussed below, each of these arguments are without merit.

Initially, appellants take issue with the appellees' position that the 1996 revised criteria in the RoC permitted consideration of mechanistic data for the known category listing. see App. Motion at 9. They claim that this position is contradicted by two pieces of evidence. Id. Thus, they argue that the District Court should not have deferred to the appellees' position regarding the revised criteria. Id. at 7-10. Appellants focus on an HHS press release and an Environment Health Perspectives ("EHP") article, that state that the revised criteria for the "known" category remain either unchanged or substantively unchanged respectively. Id. at 9. According to appellants, these statements supposedly indicate the agency's original intent that mechanistic data was not to be considered for substances to be placed in the "known" category. Id. at 8-9 Appellants' argument misses the mark.

There is ample evidence in the record demonstrating that appellees understood that mechanistic data were to be considered under the "known category," including the administrative history leading up to the promulgation of the revised criteria in 1996 and appellees' statements regarding the revised criteria following their publication.

In particular, revisions to the previous 1982 listing criteria were first proposed at an April 24-25, 1995 meeting of the NTP Board of Scientific Counselors Ad Hoc Working Group, See R. Ex. 5, at 2; see also R., Ex. 8 at 3 (Summary Minutes referring to the April 24, 1995 meeting as the "first step in the criteria review process") At that first meeting, one of the primary topics of discussion was the possible "incorporation of mechanistic data as part of the criteria for listing substances in future Reports..." R. Ex. 5, at 2 (emphasis added)

Individual "break-out" groups were assembled and each group commented on the topic. See generally Ex. 5.

Following the publication of the proposed revisions in the Federal Register on June 8, 1995, (R., Ex. 6), these comments were then presented and discussed at a June 29, 1995 NTP Board meeting. see R., Ex. 7 at 3-9. Following discussion and public comment, it was 'moved that mechanistic information should be included in the selection process for agents to be listed in the [RoC]. " Id. at 7 (emphasis added). The motion passed unanimously. Id. Nowhere during the discussions of mechanistic data was it agreed or decided that such data should be used only for the "Reasonably Anticipated" and not for the "Known" category. The references to mechanistic data were placed in an explanatory paragraph that clearly applied to both listing categories This is made plain by the fact that the descriptive or explanatory paragraph was, in some interim drafts, placed above the specific language for the two listing categories, See R., Ex. 7, last page; see also Ex. 8, at 4, the Minutes of the NTP Executive Committee Meeting on July 27, 1995, summarizing what had been done up to that point, show that the NTP Board had approved a resolution to place the "explanatory paragraph" at the beginning of the criteria. Ultimately the final paragraph was placed below the two listing categories. See R., Ex. 5, at 6; and see final criteria in R., Ex. 2, Eighth RoC at 2. If the explanatory paragraph had only been intended to refer to the second, "reasonably anticipated" category, it would never have been suggested to place it above both listing categories That simply would have made no sense.

After the explanatory paragraph had been moved back to the bottom again, the minutes of the January 26, 1996 NTP Executive Committee Meeting clearly state that "Dr. Jameson then read a final paragraph which applies to all the criteria and discusses the role of scientific judgment, and other relevant information." R., Ex. 11 at 8 (first page); see also R., Ex. 12 at 3-5. Moreover, the original proposed criteria show the explanatory paragraph with wider margins than either of the two specific listing categories, indicating by that format that they apply to both, See R., Ex. 5,at 6.

Not only does the administrative history, and logic,(3) dictate that mechanistic data be used for the "Known" category, but the appellees' own statements about the revised criteria following their publication show, with exception of the press release, that appellees understood that mechanistic data were to be considered under the "Known" category When the final, revised criteria were published in the Federal Register on September 26, 1996, the accompanying text there provided a brief summary of the review process It stated that at "each step of the review process there was concurrence with the following points ... (2) mechanistic information should be used as part of the listing criteria. " See R., Ex. 13 at 2, 6 Fed. Reg. 50499, The Federal Register text also notes just above a printing of the descriptive paragraph containing the reference to mechanistic data that "the following descriptive paragraph has been added to the criteria." Id. Nowhere does the Federal Register text differentiate between the criteria for the "Known" category and the "Reasonably Anticipated" category.(4)

With respect to the press release, it was misleading. However, it is plainly an aberration, as demonstrated by all of the other evidence indicating that mechanistic data were to be considered under the "known" category. This press release did state that the criteria had been updated and mechanistic data was included for use in the "Reasonably Anticipated" category See Amen. Cmplt. Ex. 2 It also stated that "the original criteria for listing a substance as a known human carcinogen remain unchanged... " Id. at 2 This second statement, which was not a quote from, or attributed to, anyone connected to the program, is both factually incorrect and misleading It is factually incorrect because the actual literal text of the "Known" category did change from the previous version. See R., Ex. 13 at 2. It is also misleading to the extent that it implies that the final descriptive paragraph does not apply to the "Known" category.

Although the statement is misleading, it may be understood as referring solely to the text of the "Known" category itself. Even administrative references prior to the adoption of the revised criteria indicate that there were few or modest changes to the text of the "Known" category E.g., R., Ex. 12 at 4 In fact, the NIEHS newsletter to which appellants refer, put out at the same time as the revised criteria, makes the same point. See Amen. Cmplt. Ex. 3 On one hand the newsletter states that the "major change in the BRC is that the NTP will consider all relevant information - including mechanistic data -in determining whether to list a substance " See Amen. Cmplt. Ex. 3 (emphasis added) The newsletter did not state that mechanistic data could be used only to list a substance in the "Reasonably Anticipated" category On the other hand the newsletter states that, with regard to the "Known" category, the revised criteria "are substantively unchanged," without referring to the final descriptive paragraph, and referring simply to the language under that heading.

The emphasis on the "Reasonably Anticipated" category makes sense in light of the opinion at the time that consideration of mechanistic data would have the biggest impact in connection with the "Reasonably Anticipated" category Indeed, the NIEHS newsletter goes on to say that " [m]ost substances listed in the BRC are contained in the 'reasonably anticipated to be a human carcinogen' [category] ... " Id

It is in this context that one should view the press release reference in the HHS News as well, i.e., it refers simply to the language of the category and does not make reference to the final descriptive paragraph Dr. George Lucier, Director of the Environmental Toxicology Program at NIEHS and Associate Director of NTP, states that such statements "indicating that there was little or no change in the 'known human carcinogen' category after publication of the criteria in September, 1996 related to the precise wording of the category only." See R., Ex 30 at 2.

Significantly, following adoption of the revised criteria, appellees have consistently applied its intended meaning, i.e., that the final descriptive paragraph, with its reference to mechanistic data, applies to both categories Shortly after the revised criteria were published, at the October 30, 1997 NTP Board Meeting, Dr. Lucier clearly stated that mechanistic data applied to both categories, See R., Ex. 16 at 7. He made similar comments in December, 1998, one year later, and noted specifically that mechanistic data "impacts both categories see R., Ex. 25 at 10. Thus, it is clear that mechanistic data is properly used during considerations for listing in the "Known" category.

Although appellants attempt to make much of the fact that this Court's decision did not address either the press release or the newsletter (App. Motion at 8-10), this fact is irrelevant. In its opinion, this Court made clear that appellees' interpretation of the revised criteria was entitled to substantial deference, thus clearly rejecting appellants' argument that the press release and the newsletter eviscerated the substantial deference ordinarily accorded to an agency decision. See Exhibit A at 10- 1 2.(5)

Next, appellants challenge this Court's finding that the appellees' interpretation of the revised criteria was reasonable. In particular, appellants takes issue with appellees' position that the final descriptive paragraph accompanying the revised criteria modifies both the "known" and 'reasonably anticipated" categories. See App. Motion at 11-12. As this Court properly found, appellants' interpretation of the revised criteria is entitled to substantial deference. See Exhibit A at 10, citing Thomas Jefferson University v. Shalala 512 U.S. 504, 512 (1994), and Wyoming Outdoor Council v. United States Forest Service, 165 F.3d 43, 52 (D.C. Cir. 1999). As set forth above, there is ample evidence supporting appellants' interpretation of the revised criteria.

Appellants argue that after the revised criteria were adopted, appellees did not interpret the criteria in the final descriptive paragraph as modifying both the "known" and "reasonably anticipated" categories until "the specter of this litigation was looming." see App. Motion at II Appellants' contention is clearly belied by the record. R., Exhibit 16 at 7; Exhibit 25 at 10.

Appellants also contend that permitting the agency to consider all relevant information for both the "known" and "reasonably anticipated" listings would eliminate the distinction between the two categories. see App. Motion at 11-12. Appellants' argument is baseless. The "known" and "reasonably anticipated" categories are distinct; they clearly have different standards. For example, the "known" category requires, inter alia, "sufficient evidence of carcinogenicity from studies in humans" while the "reasonably anticipated category" requires, inter alia, "limited evidence of carcinogenicity from studies in humans." see R., Ex. 13 at 2, 61 Fed. Reg. 50499; Ex. 2 at 2 (emphasis supplied). Moreover, although all relevant evidence is considered in determining where to place a particular substance, a substance's placement in the "known" or "reasonably anticipated" categories depends on what the data reveals.

Further, appellants maintain that dioxin should be included in the "reasonably anticipated" category because the "undisputed data" on dioxin make it a "perfect fit" with the "reasonably anticipated" category. see App. Motion at 11-12. Appellants' argument constitutes nothing more than a disagreement with appellees' conclusion that dioxin should be placed in the "known' category. This disagreement takes appellants nowhere. As the District Court correctly opined, "defendants, as an agency charged with making scientific judgments, [are] due great deference." see Exhibit A at 11, citing Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971). Appellants simply have no basis to support their view that the District Court should have in effect, accepted their position on dioxin over that of the appellees.

Equally unavailing is appellants' argument that the "all relevant information" language would permit upgrades to the "known" category based on mechanistic data, where the human data are insufficient. see App. Motion at 12. Contrary to appellants' claim, the record evidence plainly shows that substances are placed in the "known" category only when human data is sufficient, and that data includes both mechanistic and epidemiological data. see R. Ex. 30 at 4.

Still further, appellants challenge the District Court's conclusion that the presentation of the proposed change in the Federal Register supports the appellees' position. see App. Mem. at 13. They assert that appellees urged the District Court to disregard the formatting in the Federal Register. Id. at 13 Appellants' argument is groundless. In fact, appellees never urged the District Court to disregard the formatting in the Federal Register. At most, appellees explained why the placement of the final descriptive paragraph changed from top to bottom in the text of the Federal Register, while consistently maintaining that this paragraph applied to both the known and reasonably anticipated categories. see Defendants' Memorandum in Opposition to Plaintiffs' Motion for Preliminary Injunction ("Def. Opp.") at 20-23.

Finally, appellants claim that appellees have never provided public notice and a reasoned explanation for their decision to allow consideration of mechanistic data to support known category listings. see App. Motion at 14 Appellants' argument is baseless. As shown above, the administrative history demonstrates that the agency sought public comment about the consideration of mechanistic data and also explained its reasons for considering this data in the known category listing.

As the foregoing demonstrates, the decision of the District Court should be summarily affirmed.(6)

B. Appellants' Motion for Injunction Pending Appeal Should Be Denied

In deciding a motion for injunction pending appeal, this Court must weigh the (1) the likelihood that the party seeking the stay will prevail on the merits of the appeal; (2) the likelihood that the moving party will be irreparably harmed absent a stay; (3) the prospect that others will be harmed if the Court grants the stay; and (4) the public interest in granting the stay. Hilton v Braunskill, 481 U.S. 770, 776 (1987); Cuomo v. United States Nuclear Regulatory Comm'n. , 772 F.2d 972, 974 (D.C. Cir. 1985). In order to prevail on this motion, appellants must establish "either a high probability of success and some injury, or vice versa." Cuomo, 772 F.2d at 974 Appellants have failed to meet this high standard, and their motion should be denied.

1. Appellants Cannot Establish Any Likelihood of Prevailing on the Merits on Appeal.

As discussed above, appellants cannot establish a likelihood of success on the merits. Notably, even if they are able to show that irreparable harm will result absent a stay, if they cannot also establish likelihood of success on the merits, the injunction pending appeal should not be granted. Blankenship v. Boyle, 447 F.2d 1280 (D.C. Cir. 1971) Ultimately, appellants fail to demonstrate that they have any likelihood of prevailing on the merits on appeal.

2. Appellants Cannot Establish Irreparable Harm.

Appellants also fail to present any basis to conclude they will be irreparably harmed. In this Circuit, Wisconsin Gas Co. v. FERC 758 F.2d 669 (D.C. Cir. 1985), set forth the guiding criteria that must be satisfied to support a finding of irreparable harm.

[T]he injury must be both certain and great; it must be actual and not theoretical. Injunctive relief "will not be granted against something merely feared as liable to occur at some indefinite time, "[citation omitted]; the party seeking injunctive relief must show that "'[t]he injury complained of [is] of such imminence that there is.a 'clear and present' need for equitable relief to prevent irreparable harm."

Id. at 674 (citation omitted) Thus, the injury must be certain and great, and must be actual and not theoretical. Id.

Appellants state that the District Court found that they had demonstrated a threat of injury sufficient to support standing, and they appear to suggest that this finding is sufficient to establish irreparable harm. see App. Motion at 14-15. But appellants cite no case law to support this sweeping conclusion, In fact, the injury required to confer standing is much less exacting than that necessary to support a finding of irreparable harm.

In concluding that appellant Brevet had standing, this Court found that "the 'injury in fact' necessary to support standing may be based on an affiant's 'reasonable concerns about the effects of the threatened harm." see Exhibit A at 6, citing Friends of the Earth, Inc. v. Laidlaw Envtl Servs. (TOC), Inc. 120 S.Ct. 693, 698 (2000). It found that appellants' affidavit met this standard. Id This finding does not support appellants' contention that they have established irreparable injury. There can be no doubt that "reasonable concerns about the effect of a threatened harm" is much different from a certain, great and actual injury. See Wisconsin Gas Co., 758 F.2d at 674. Appellants' alleged harm is simply too speculative to constitute irreparable injury.

Appellant Brevet, a California firm which manufactures polyvinyl chloride ("PVC") connectors for use in surgery and other medical procedures, claims that several activists have attempted to link PVC manufacturing and disposal to environmental dioxin levels, and these groups would trumpet the proposed dioxin listing in furtherance of their efforts to eliminate all PVC use. App. Motion at 15. Brevet claims that it has already lost some customers due to public and shareholder concern regarding dioxin, and it has a reasonable basis to conclude that additional losses would follow from listing dioxin in the known category. Notably, the cities of San Francisco, Oakland and Berkeley, California have all passed resolutions setting as a goal the elimination of polyvinyl chloride ("PVC") incineration and the reduction and/or elimination of PVC plastic use in the San Francisco Bay area. see Amen. Cmplt. Ex. 5, 6, 6A. These resolutions, which are very similar to each other, have attached to them an appendix listing scientific publications or pronouncements supporting the carcinogenicity of dioxin. Id Listed there, among some twenty other listings and publications, including the IARC(7) Monograph, is a reference to the NTP Board of Scientific Counselors of the National Institute of Environmental Health Sciences ("NIEHS"), dated 1997. Id These city resolutions may be harbingers of public opinion against dioxin and PVC plastic in the San Francisco Bay area. But any conclusion as to whether, when or how much business Brevet will or may lose is wholly speculative. Likewise, which of Brevet's customers will ever stop buying PVC plastic, when and how much is completely speculative. Thus, Brevet's alleged injuries are conjectural and hypothetical. Brevet has not shown that an upgrade in the listing of dioxin has or will cause it to suffer an "injury in fact [that is] actual or imminent, not conjectural or hypothetical." -see Wisconsin Gas, supra.

Moreover, appellants argue that they have shown irreparable injury because they will be unable to recover money damages from the government. see App. Motion at 15. But this fact alone does not obviate appellants' need to show severe economic injury. WMATC v. Holiday Tours, Inc. 559 F.2d 841, 842-43 (D.C. Cir. 1997). Appellants have failed to show anything even close to severe economic impact. In fact, it is far from certain that appellants would suffer lost sales and damages to their business relationships if dioxin is listed in the "known" category in the RoC. If this Court denied appellants' request for an injunction, and appellees published dioxin in the known category in the 9th RoC, appellees could always revise the publication if this Court ultimately determined that the agency had acted arbitrarily and capriciously.

Finally, whether appellants' alleged future harm could be redressed by a favorable decision of this Court is also speculative. see University Medical Center of Southern Nevada v. Shalala, 173 F.3d 438, 441 (D.C. Cir. 1999). Even if appellants were to convince this Court that appellees have been arbitrary and capricious in the steps leading up to publication of the RoC, an injunction against the publication of an RoC listing dioxin in the "known" category would not solve appellants' problem. It is apparent just from the list of citations appended to the three city resolutions referred to above that a great number of scientific and political groups have already taken positions supporting the containment and regulation of dioxin exposure. Even if an NTP re-review of dioxin were ultimately ordered, it is most unlikely that such a decision would alter the underlying groundswell of public opinion against dioxin,

Thus, for all the above reasons, appellants cannot establish irreparable harm,

3. The Public And Private Interests Favor Denial Of Appellants' Motion For Injunction.

For the issuance of an injunction, this Court must also assess the possible harm to other parties in granting the requested injunction, and the public interest. Here, there is no basis for concluding that the "injury" to appellants from denying the injunction would be any greater than the injury to other parties from granting an injunction.

Appellees have a statutory obligation to publish the RoC, and they have been unable to finalize the 9th RoC because of this litigation. Appellees' conclusion that dioxin should be listed in the "known" category was reasonable. The public has the right to this information. There is no basis to continue to withhold this important health information from the public, especially in light of the fact that appellants' harm is speculative and, ultimately, de minimis, and their possibility of prevailing on the merits is significantly low.


For the reasons stated above, appellees respectfully request that the decision of the District Court be summarily affirmed and that appellants' motion for injunction pending appeal be denied.

United States Attorney

Assistant United States Attorney

Assistant United States Attorney

Of Counsel:

Patricia Kvochak, Esq.
U.S. Department of Health and Human Services


I HEREBY CERTIFY that, on November 27, 2000, 1 served a copy of the foregoing Appellees' Motion for Summary Affirmance, and Opposition to Motion for Injunction Pending Appeal by first class mail, postage pre-paid, on the following:

Charles Fromm, Esq.
Multinational Legal Services, P.C.
11 DuPont Circle
Washington D.C. 20036
Stacy M. Ludwig
Assistant United States Attorney
Judiciary Center Building
Room 10-120
555 Fourth Street, N.W.
Washington, D.C. 20001
(202) 514-7147

1. The appellees include: the United States Department of Health and Human Services ("HHS"); Donna E. Shalala, Secretary of HHS; Kenneth Olden, Director, National Institute of Environmental Health Sciences ("NIEHS") and Director, National Toxicology Program ("NTP"); and Christopher Portier, Director, Environmental Toxicology Program ("ETP").

2. The District Court correctly found that appellants Jim Tozzi, Empire State Tavern and Restaurant Association, Greenbaun & Gilooley lacked standing. See Exhibit A at 2-8. It also found that appellant Brevet Industries and Brevet, Inc. ("Brevet") has standing. Appellees submit that Brevet lacks standing as well. However, it is plain that appellees should prevail on the merits of this appeal, and they urge this Court to deny appellants' motion for injunction pending appeal and to grant appellees' motion for summary affirmance.

3. It simply makes no sense that, after lengthy debate and discussion, appellees would preclude the use of mechanistic data, a powerful and emerging tool in toxicologic analysis, for consideration under the "Known" category, which is the highest listing category possible.

4. 'Notably, appellants have never addressed, and are unable to controvert, the fact that at both the October 1997 public meeting and the December 1998 public meeting at which the proposed dioxin listing was discussed, the Associate Director of the NTP made it perfectly plain that mechanistic data could be applied to both the known and the reasonably anticipated categories. See R, Ex. 16 at 7; Ex. 25 at 10. Moreover, six months prior to the filing of this lawsuit, Dr. Olden, Director of the NTP, sent a letter directly to appellant Tozzi reaffirming the agency's interpretation of the revised criteria. R., Ex. 23 at 1.

5. Recently, this Court reiterated the principle that an agency's interpretation is entitled to deference so long as there is no reason to suspect that the interpretation does not reflect the agency's fair and considered judgment. Bigelo v. Dep't of Defense 217 F.3.d 875, 878 (D.C. Cir. 2000). And this is true even if the agency's interpretation appears only in a legal brief. IdHere, of course, the record firmly supports the interpretation that appellees have advanced in court.

6. This case does not raise any prior restraint issues because that doctrine generally applies to the government's attempt to place a restriction on speech, which is not at issue here. see e.g. Nebraska Press Ass'n v. Stuart, Judge 427 U.S. 539, 557 (1976)(citation omitted) ('The main purpose of the First Amendment is 'to prevent all such previous restraints upon publications as had been practiced by other governments "')(citations omitted).

7. International Agency for Research on Cancer is a highly respected subgroup of the World Health Organization.