IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

EPA'S REPLY IN SUPPORT OF ITS
MOTION TO DISMISS

Responding to EPA's contention that the Court should dismiss the Complaint for want of a waiver of sovereign immunity, a cause of action, and standing, the Plaintiffs persist in arguing:

1. That Agency statements concerning risks associated with exposure to dioxin and the carcinogenicity of pyrethrins either are or will be final agency action, notwithstanding Plaintiffs failure to allege that the challenged documents have any binding regulatory impact on any person or institution inside or outside of EPA; and
   
2. That each Plaintiff has standing to challenge the dissemination of information about these two categories of chemicals by EPA because the information alone will harm them, notwithstanding the fact that such a conclusion requires extraordinary speculation about the behavior of third parties.

On the contrary, the Court should proceed to dismiss the case, first, because neither of the informational documents the Plaintiffs seek to challenge constitutes either "final agency action" under the test enunciated in Bennett v. Spear, 520 U.S. 154 (1977) ("Bennett"), or even "agency action" for purposes of Industrial Safety Equipment Assn. v. EPA, 837 F.2d 1115 (D.C. Cir. 1988) ("ISEA"); and second, because no Plaintiff can point to a reasonably immediate injury that is both likely to occur and subject to redress in this action.

I. THERE IS NO AGENCY ACTION TO REVIEW

   The Plaintiffs necessarily rely upon the APA both for a waiver of sovereign immunity and to supply a cause of action. APA § 10(a), 5 U.S.C. § 702 (waiver); APA § 10(c), 5 U.S.C. § 704 (claim for judicial review). Yet neither the waiver nor the cause of action is present without "agency action," a statutory term of art meaning "the whole or a part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act." APA § 4(b), 5 U.S.C. § 551(13). The Parties agree that an agency decision not providing a direct command may be agency action if it nevertheless has controlling legal effect, as was the case with the biological opinion in Bennett. 520 U.S. at 178 ("the Biological Opinion and accompanying Incidental Take Statement alter the legal regime to which the action agency is subject..."); see Appalachian Power Company v. EPA, 208 F.3d 1015,1023 (D.C. Cir. 2000) (EPA's "Periodic Monitoring Guidance" bound State regulatory personnel and so impacted the regulatory community—"`rights' may not be created, but "obligations" certainly are..."). And the Plaintiffs must acknowledge (though they protest vigorously) that an expression of opinion by EPA that does not determine legal relationships is not subject to review - because controlling precedent in this Circuit so holds. ISEA, 837 F.2d at 1116 (" We hold . . . that the . . . [EPA's] respirator recommendations do not constitute agency action that will sustain . . . an APA . . . claim").^1/

   The unanimous panel in ISEA faced precisely the argument that dominates the Plaintiffs' papers in this case - a suggestion that the expression of an opinion by a federal agency would be taken as authoritative, and would completely eliminate the commercial viability of a product. Compare Complaint ¶¶ 40, 49 (emphasizing the non-regulatory impact of the Agency documents) and Plaintiffs' Opposition at 9 ("significant economic consequences for affected parties") with ISEA, 837 F.2d at 1118 and n.7 (referencing the harm done by adverse publicity alone). The Court resolved the issue not by resorting to a theory that practical impact alone could establish the presence of agency action (as the present Plaintiffs would prefer), but by reference to the Circuit's precedents and to the language of the APA.

   The rule established in the case is that the dissemination of information without direct or indirect regulatory consequence does not constitute agency action, and is therefore not subject to judicial review:

ISEA, 837 F.2d at 1121. Concerns about harm from the wrongful dissemination of information are provided for, at least in dicta, by an exception. Should a Plaintiff provide evidence that publicity is intended specifically to penalize a party, particularly in the presence of a credible suggestion that the information being disseminated is demonstrably false, the publication of non-regulatory material might be reviewable as a "sanction" in accordance with the applicable APA definition. 837 F.2d at 1119.^2/ The principal question before the Court is therefore whether the Plaintiffs have alleged facts sufficient to make a case: (1) that either of the two documents being challenged - the pyrethrins cancer assessment or the forthcoming dioxin risk assessment - represent Agency decisions in which "rights or obligations have been determined" or from which "legal consequences will flow," Bennett, 520 U.S. at 178; or (2) that the Agency has set out to coerce them through the unjustified dissemination of false information about the products at issue. ISEA, 837 F.2d at 1119.^3/

   The answer to the first question is entirely straightforward. Despite suggestions that they will suffer if the Court does not prevent the Agency from communicating with the public about pyrethrins and dioxins, neither the complaint nor the Plaintiffs' subsequent papers alleges that the challenged documents have determined the legal rights of any Plaintiff—directly or indirectly. The situation is not at all like that in Bennett, in which the challenged "biological opinion" was legally determinative of subsequent action to be taken by the Bureau of Reclamation.^4/ Nor is it similar to Appalachian Power, in which the Court determined that EPA's guidance document was being applied in a manner that imposed legally binding controls on the regulated community.^5/ Even a cursory examination of the challenged documents reveals that they are collections of references to the latest scientific information about dioxins and pyrethrins, together with commentary by the Agency's scientific staff. Neither requires anything from any regulated entity, neither provides a policy statement that binds Agency officials, and neither has the kind of indirect regulatory consequence described in Bennett - and there is no allegation in the Complaint that implies otherwise.^6/

   Decisions made in the agency proceedings subject to challenge in both Bennett and Appalachian Power changed legal rights. Here, in contrast, the Plaintiffs have confined themselves to allegations about the practical impact of the Agency's release of information. In precisely the same way that the burdened respirator manufacturers suggested in ISEA, the Plaintiffs say that publication may induce third parties to restrict purchases of the Plaintiffs' products. See, e.g., Complaint ¶¶ 39-40, 49. Perhaps EPA will eventually promulgate new regulations pertaining to burning materials that may lead to dioxin formation. See Plaintiffs' Opposition at 9. Perhaps the feared "policy shifts" in EPA's waste and water offices will come to pass. Id. Perhaps the pyrethrins science will eventually lead to restrictions not presently in place on the use of one or more pesticides. Perhaps, as the Plaintiffs' affiants fear, customers will eventually seek substitutes for PVC connectors in medical applications, and will move on to other pesticide products.^7/ But these consequences are identical in substance to those faced by the manufacturer of a problematic respirator following ISEA. 837 F.2d at 1121("Unions may stiffen their bargaining positions on safety precautions. Perhaps sales of several respirator types will decline; perhaps not, if appellants are correct in their view. . ."). Unless and until the Agency's opinion develops regulatory traction there is no agency action and the Court may not hear the case.^8/

   Because the Plaintiffs disapprove of the rule in ISEA, they do not address the D.C. Circuit's suggestion that there might be an exception to the general rule if an agency deliberately widely publicized false statements. See ISEA, 837 F.2d at 1119. There is no allegation in the Complaint, and no statement in the remaining papers, suggesting that EPA's forthcoming dioxin risk assessment contains false statements. That is hardly surprising, because even the Agency's present publications on dioxins make it clear that at least one chemical in the dioxin family (the one abbreviated 2,3,7,8-TCDD) is among the most potent carcinogens yet discovered. Without the allegation, the Plaintiffs cannot meet the exception referenced in ISEA, and the Complaint must be dismissed .^9/

   The situation with regard to EPA's existing cancer assessment for pyrethrins is only slightly more complicated. Once again, the Complaint makes no allegations addressed either to the veracity of EPA's conclusion that pyrethrins may be associated with cancer in humans or to any deliberate intention on the part of EPA to generate wide publicity about pyrethrin products as a sanction. Affiant Henderson, however, does indicate that he disagrees with the Agency's conclusions (and that he has bet the future of his company on that disagreement):

Henderson ¶ 3, 12. It is difficult to determine from this statement whether the affiant actually disagrees with the Agency's basic viewpoint about the potential carcinogenicity of pyrethrins. Perhaps he merely intends to support the Plaintiffs' argument that the categorization of that chemical is based on the wrong Agency guidance regarding risk assessment. Compare Complaint ¶ 38. Yet even if he flatly disagrees with the Agency's science community, the proper course remains dismissal of the complaint, because the Plaintiffs' papers contain no allegations or testimony tending to establish either: 1) that EPA is aware that its basic conclusion about pyrethrins is false; or 2) that the Agency affirmatively sought widespread publicity for its findings in an effort to coerce Diatect to stop using particular ingredients in its pesticides or to otherwise injure the Company. Compare ISEA, 837 F.2d at 1119 (no "evidence that the Guide was intended to penalize producers or consumers of the eleven lawful, but criticized respirators...") with Flue Cured Tobacco, 857 F. Supp. at 1140,1142 (allegations of widespread manipulation of research data, and announcement of those results by EPA's Administrator in a widely publicized ceremony).^10/ If simple disagreement with EPA's conclusions were sufficient to meet the ISEA exception, virtually every report penned by Agency personnel would be subject to immediate judicial review.

II.NO PLAINTIFF HAS DEMONSTRATED STANDING

   There is no dispute between the Parties about the test the Plaintiffs must meet to establish their standing to proceed with the litigation. Each must establish injury in fact, "a fairly traceable connection between the . . . injury and the complained-of conduct," ("causation"), and "a likelihood that the requested relief will redress the alleged injury" ("redressability"). Steel Co. v. Citizens for a Better Env't., 523 U.S. 83, 103 (1998); compare Plaintiffs' Opposition at 5.^11/

   It is important to remember, for purposes of the following analysis, that the Plaintiffs' allegations regarding injury depend entirely on the expected actions of third parties. Although it is true, as the Plaintiffs say, that "[i]t would be impossible to maintain . . . that there is no standing to sue regarding action of the defendant which harms the plaintiff only through the reaction of third persons," Block v. Meese, 793 F.2d 1303, 1309 (D.C. Cir. 1986), the following proposition is equally well established:

Lujan v. Defenders of Wildlife, 504 U.S. 555, 562 (1992) ("Lujan") (citations omitted); see Natural Law Party v. FEC, i 11 F. Stipp. 2d 33, 47 (D.D.C. 2000). Not one of the present Plaintiffs can satisfy the applicable standard.

A. The Harm Allied By the Brevet Plaintiffs Is Speculative

   The Brevet Plaintiffs ("Brevet") claim standing on the basis of conclusory allegations in the Complaint (e.g., Paragraphs 22, 49) and Mr. Brewer's Affidavit, which implies that the Agency's forthcoming update of its dioxin risk assessment is a threat to Brevet's business model. Parsed carefully, however, the testimony does not support a claim that the supposed injury is even likely to occur.

   First, any suggestion by the witness that regulation or activism bolstered by the Agency's forthcoming findings threatens Brevet's business model is undermined by the witness' own testimony that: (1) PVC connectors are used in open-heart surgery and other high-end medical procedures (and so are hardly a trivial item we can do without) (Brewer ¶ 4); (2) that he is unaware of any "presently available substitute material for PVC tubing that offers the physical properties necessary to perform the critical functions of the devices used with the connectors Brevet produces" (Brewer ¶ 5); (3) that the Company's products are exceptionally cost-effective for their intended uses (Id.); and (4) that the same products are also "medical devices" that require federal approval before marketing (a substantial barrier to entry for any would-be substitutes) (Id.). EPA's update cannot be a real or imminent threat to Brevet's business interests under these circumstances.

   Indeed, the critical portions of the testimony the witness provides are explicitly speculative. We are told that Brevet may suffer a 95% loss in revenue "if" the use of PVC tubing were discontinued, and that a smaller loss would occur "if' sales of flexible PVC connectors were banned. Brewer ¶ 10. The materials the Brevet relies on to show harm actually: (1) confirm that there is no present substitute for many PVC medical devices (which again precludes any harm in the foreseeable future);^12/ (2) confirm that dioxins are already perceived by the Company's customers as a "known carcinogen " (raising questions about the likelihood of the predicted third party conduct and about causation);^13/ and (3) that the third parties said to be on their way to abandoning PVC products appear to be doing so, in part, due to the presence of perceived health effects of a completely separate chemical that leaches from such products during use (which raises still more questions about causation and redressability).^14/ EPA does not mean to belittle Mr. Brewer's concern. Careful attention to even the most distant and speculative threats is frequently the measure of a successful businessman. But the Court is bound to make a more searching inquiry, and threats sufficient to confer standing must be "actual and imminent," not "conjectural" or "hypothetical." Lujan, 504 U.S. at 560; see Los Angeles v. Lyons, 461 U.S. 95, 101-02 (1983).^15/

   Second, as pointed out in EPA's moving papers, the statements in the present affidavit are virtually identical to those advanced when the same Plaintiff sought to prevent HHS from issuing its 9^th Report on Carcinogens in Tozzi I 51 Env't Rep. Cas. at 1894.^16/ Brevet cannot expect to have it both ways. If, on the one hand, a statement by the United States Government that dioxin is known to cause cancer in humans is sufficient to produce the harm referenced in the testimony, then the injury has already occurred with publication of the 9^th Report following Tozzi I Id. By definition, nothing in EPA's forthcoming report will alter a result that the witness has already described as inevitable following publication by HHS. If, on the other, the Plaintiffs now take the position that the HHS report will not cause the harm described (as it would seem they must), then there is reason to question the reliability of the witness' judgment about the impact of any single report about dioxin on Brevet's business.

   Moreover, once the Plaintiffs acknowledge that no particular report is critical, both causation and redressability become problematic: causation because the harm comes not from any individual statement about dioxins, but from an emerging consensus in the scientific community; redressability because an injunction regarding this particular report cannot be expected to hold back flooding that is already in progress.^17/ There is no dispute in the case about the fact that dioxins have already been regarded by the Agency for years as a probable, and extremely potent, human carcinogen, and that the facts about the characteristics of the chemicals as a group are widely accepted in the scientific community. Having cried "wolf' once with regard to the HHS document, Mr. Brewer cannot reasonably expect to enlist the Court's aid again in an attempt to muzzle yet another government agency that is poised to confirm that which is already well known.^18/

B. The Harm Alleged By The Diatect Plaintiffs Is Equally Speculative

   Diatect's claims to standing, also supported by affidavit, are similarly without solid foundation. As in the case of the forthcoming dioxin risk assessment, the pyrethrin cancer assessment has no direct impact on Diatect, and this Plaintiff also relies on the supposed activities of third parties to obtain standing—subjecting it to the heightened burden defined in Lujan.

   Diatect falls substantially short of the demonstration required. Affiant Henderson expresses "great concern" (Henderson ¶ 10), but fails to substantiate the expected behavior of third parties in any meaningful way. Indeed, the only materials referenced in an effort to meet the additional burden imposed when standing depends on predictions about third party activity are Exhibits 3 and 4 to the Complaint. Id. Exhibit 3 appears to be a general informational document that simply references probable carcinogenicity among numerous other characteristics. Exhibit 4 is an extensive treatment about the risks of using pesticides in general in the New York school system. The exhibit does appear to list the challenged document as a source of information about the carcinogenicity of pyrethrins, but the presentation does not argue for the elimination of pyrethrins. Instead, the entire document presses for minimization of the use of pesticides in general in and around New York's school-aged children. It is entirely possible that the reader of this document would continue to prefer pyrethrin based products to more "traditional" pesticides (which may present comparatively greater risks), while simply taking the well-founded kinds of precautions identified in the document when dealing with pesticides and children. These two citations do not make the case for standing based on the action or inaction of third parties.

   Even if that were not the case, however, publicly available information - including information
available today on EPA's own web site - affirmatively suggests that the affiant's stated fears are without substantial foundation. There are, after all, no "risk-free" pesticides, and even a regulatory agency like EPA continues to recommend Pyrethrins as substitutes for the more problematic organophosphate products.^19/ Even the highly sensitive consumers the witness describes as constituting Diatect's niche markets (Henderson ¶ 5) are likely to continue to use the Company's products in preference to "traditional" pesticides - even those traditional products that remain on the market. They may be a bit more skeptical than before about the Company's "zero days to harvest" claims (Id.), but it is unlikely that they will abandon the relatively environmentally-friendly pyrethrins en-masse for something they take to be worse.

C. Tozzi's Allegations Do Not Support Standing

   The Plaintiffs offer no argument in support of individual Plaintiff Tozzi's standing beyond the allegation that "Tozzi and his wife are purchasers and consumers of pyrethrin-containing products, including pet shampoo and garden and house plant insecticides. Defendants' action threatens the continued availability of such products." Complaint ¶ 20. These are functionally identical to the allegations Judge Sullivan found inadequate in Tozzi I, even as the case was allowed to proceed with regard to allegations advanced by Brevet. Tozzi 1, 51 Env't Rep. Cas at 1895. There is no basis for a distinction here, and Tozzi provides no indication that there is any basis whatsoever for the fear expressed. The portion of the case brought by Plaintiff Tozzi should be summarily dismissed.^20/

CONCLUSION

For all these reasons, and for those stated in EPA's initial moving papers, the Court should dismiss the Complaint without proceeding to consider the pending motion for preliminary relief.

ENDNOTES:

^1/ The Plaintiffs' citation of two district court opinions from outside the circuit merely serves to emphasize the point. Plaintiffs' Opposition To Defendants' Motion to Dismiss For Lack Of Jurisdiction at 8-9,12-14 (served March 22, 2001) ("Plaintiffs' Opposition"); see SOCMA v. HHS, 720 F. Supp. 1244 (W.D. La. 1989); Flue-Cured Tobacco Coop. Stabilization Corp. v. EPA, 857 F. Supp. 1137 (W.D.N.C. 1994). SOCMA, decided shortly after ISEA, does not discuss Judge Wald's opinion, but expresses view. directly contrary to the D.C. Circuit's holding. Compare, SOCMA, 720 F. Supp. at 1249 ("the issuance of the Annual Report is agency action even though it is informational and imposes no sanctions or obligations") with ISEA, 837 F.2d at 1119 (Guide is neither a "rule" nor a "sanction" for APA purposes). In Flue Cured Tobacco, Judge Osteen purported to distinguish ISEA, but also made it abundantly clear that he would have decided the case differently. 857 F. Supp. at 1143 (criticizing the D.C. Circuit's "narrow and legalistic analytical approach").

^2/It is perhaps ironic given Judge Osteen's criticism of ISEA in Flue-Cured Tobacco that the Court's characterization of the allegations there made - accusing the Government of aiming publicity about "second-hand smoke" directly at their business interests, while knowing that information being published was false -suggest a case that might have survived a motion to dismiss in the D.C. Circuit. See FlueCured Tobacco, 857 F. Supp. at 1140 (referencing allegations of "cherry-picking" data and otherwise deliberately manipulating research results). The Plaintiffs' citation of Troy Corp. v. Browner, 120 F.3d 277 (D.C. Cir. 1997) (Plaintiffs' Opposition at 9) adds nothing to the argument. The Appellants in that case challenged a rulemaking adding chemicals to EPA's toxic release inventory, an action that had immediate legal consequences. See Troy Corp., 120 F.3d at 280 (referencing TRI reporting requirements). EPA expressly identified its action as rulemaking, and there appears to have been no contest in the case about the presence of agency action.

^3/Given the Plaintiffs' constant focus on what it says is disarray in EPA's handling of the Agency's various publications relating to proper techniques for conducting cancer risk assessments, it is worth emphasizing that the only documents actually challenged here are the recently published pyrethrins cancer assessment, and the yet to be published revision of the existing dioxins risk assessment. If neither of those is agency action, the Court may not hear the case, and the complaint must be dismissed.

^4/ Bennett, 520 U.S. at 178 (" [T]he Biological Opinion and accompanying Incidental Take Statement alter the legal regime to which the action agency is subject, authorizing it to take the endangered species if (but only if) it complies with the prescribed conditions").

^5/ Appalachian Power, 208 F.3d at 1023 ("[T]he entire Guidance, from beginning to end . . . reads like a ukase. It commands, it requires, it orders, it dictates . . . EPA has given the States their `marching orders' and EPA expects the States to fall in line. . .")

^6/The Plaintiffs do allege that a draft of the dioxin reassessment has been "used in the regulatory context, including Superfund site risk assessments and remedial action decisions." Complaint ¶ 17. But that is no criticism at all, and ,certainly does not support a conclusion that the reassessment itself, once published, will constitute agency action. "Use" of the best available scientific material—conveniently collected in the challenged document—is precisely what would be expected of a studious risk assessor, and does not make the document itself determinative of any right or obligation. See NRDC v. EPA, 16 F.3d 1395, 1407 (4' Cir. 1993) (1984 dioxin criteria document was non-regulatory, and "simply serves as a useful guide to assist the states in developing their own respective water quality standards"). There appears to be no similar allegation regarding the pyrethrins cancer assessment. The Plaintiffs suggest that various draft guidance documents have been similarly "used" in 40 or more herbicide and pesticide review proceedings (Complaint ¶ 31), but these documents are not among those challenged in the action. See Note 3, supra.

^7/ Affidavit of Charles Brewer In Support Of Plaintiffs' Application For Preliminary Injunction ¶¶ 7-10 ("Brewer"); Affidavit of George H. Henderson In Opposition To Defendants' Motion To Dismiss ¶ 12 ("Henderson").

^8/ This does not mean, of course, that the conclusions about dioxins and pyrethrins found in the challenged documents and subsumed in future activities that do have regulatory impact would avoid review. The APA specifically permits review of matters "preliminary, procedural, or intermediate" once final agency action occurs. See APA § 10(c), 5 U.S.C. § 704.

^9/The Plaintiffs rely on Flue Cured Tobacco to provide a rationale for distinguishing ISEA. Plaintiffs' Opposition at 13. But the reasons provided are unconvincing. First, the characterization of one document as "advisory," and the other as "declaratory," adds little to the analysis. Certainly the manufacturers of troubled respirators would have found the "Guide" in ISEA sufficiently "declaratory" to do them great harm. Second, it is unclear why the Court found specific statutory authorization pertinent, as it would make no difference either in the potential for legal impact or in the "practical consequences" that drive the Plaintiffs' concern here. Third, the conduct of notice and comment procedures surely cannot be determinative. To make them so would be to encourage agencies in general to avoid public comment on any activity but formal rulemaking - surely something even the present Plaintiffs would wish to avoid.

^10/ There is no allegation here that the Agency has embarked on an effort to penalize Diatect. The affiant is primarily concerned about widespread publicity the Diatect fears will be provided by third parties - ones already inclined to a particular viewpoint concerning what the Company presently advertizes as "green" products. Henderson ¶ 39 ("EPA's classification of pyrethrins as `likely' human carcinogens has been noted by certain `pesticide watchdog' and other activist[] groups . . . These groups have placed the EPA classification information on the Internet in a context designed to convince the public that such substances are toxic and unsafe"). EPA, in fact, continues to recommend pyrethrin-based products as alternatives to more problematic pesticides. See, e.g., Note 19, infra.

^11/ EPA does dispute the Plaintiffs' apparent contention that each may proceed with the litigation if even one demonstrates standing. Plaintiffs' Opposition at 28, citing Walt v. Energy Action Education Found., 454 U.S. 151, 160 (1981). The fact that the Supreme Court would not need to inquire as to the status of each Plaintiff to decide the questions before it does confer on any Plaintiff aright to "piggy-back" on the standing of others, and litigants without standing are commonly excused—as Mr. Tozzi well knows. Tozzi v. HHS, 51 Env't Rep. Cas. (BNA) 1983 (D.D.C. 2000) ("Tozzi l') (dismissing three plaintiffs, including Mr. Tozzi, for want of standing). See also Rio Grande Pipeline Co. v. FERC, 178 F.3d 533, 537-39 (D.C. Cir. 1999) abrogating American Train Dispatchers Ass'n v. ICC, 26 F.3d 1157, 1162 (D.C. Cir. 1994) (intervenors seeking party status must demonstrate standing).

^12/ U.S. Opposition to Preliminary Injunction, Exhibit D at 3(served March 23, 2001) ("U.S. Opposition to Preliminary Injunction") (indicating that "the medical industry is continuously evaluating new materials," and that a replacement for PVC would be accepted only "[i]f the overall performance and safety of an alternative material were proven to be superior to plasticised PVC . . . for a number of applications no real alternative material . . . has so far been found"); Brewer Exhibit 1 at 1 (Brevet client Tenet would replace PVC products only if "they are of the same or better functionality as those they would replace and are readily and reliably available at reasonable prices").

^13/Brewer Exhibit I at I (referring to dioxin as a "known carcinogen and reproductive toxin").

^14/U.S. Opposition to Preliminary Injunction, Exhibit D at 3 ("Plasticizers called phthalates have also been found to leach from flexible medical products . . . leaching may lead to health effects, particularly in vulnerable groups such as premature infants"); Brewer Exhibit 1 at 1 (referencing both phthalates and dioxin issues) (emphasis supplied).

^15/There are numerous additional considerations that may yet limit the harm Brevet says it fears. Taking just a single example, the affiant's treatment of the issue completely overlooks the fact that the difficulty with PVC would relate to manufacture and disposal of Brevet's products (the processes in which the dioxins would be formed and released to the environment). There is necessarily an implicit assumption in Mr. Brewer's testimony that no safe, alternative means of manufacture or disposal can be found that will allow continued use of what the Company says are inexpensive products well-suited for their intended use. Such a result might raise the cost of making and using PVC somewhat (as environmental regulations do in many aspects of daily life), but it would hardly destroy the market for PVC-based medical products.

^16/ See U.S. Opposition to Preliminary Injunction at 30.

^17/ See U.S. Opposition to Preliminary Injunction at 26-29.

^18/ This same admission also displaces the Plaintiffs' reliance on Block v. Meese, 793 F.2d at 1309 (D.C. Cir. 1986), which the Court was inclined to acknowledge in Tozzi I, because it is the emerging consensus about dioxins, not the forthcoming risk assessment, that drives opposition to PVC use.

^19/ See, e.g., www.epa.gov/pesticides/announcement6800.htm (updated June 9, 2000); www.epa.gov/ pesticides/op/chlorpyrifos/alternatives.htm (updated August 21, 2000) (indicating the elimination of the widely used organophosphate sold under the trade name "Dursban for "nearly all household purposes," and recommending pyrethrin based products as alternatives in the pet products, home, home lawn and ornamental, and mosquito control categories). For a layman's treatment of the problems with organophosphates, See https://www.epa.gov/pesticides/op/primer.htm. For the Court's convenience, printed versions of these hypertext documents are attached as Addendum 1.

^20/ The Plaintiffs do suggest in papers relating to their proposed preliminary injunction that Tozzi and Diatect have standing to challenge the dioxin risk assessment even absent a direct stake in the controversy - because of the perceived precedential impact of the dioxin assessment. See Memorandum Of Points And Authorities In Support Of Plaintiffs' Application For Preliminary Injunction at 2 n. l (served January 29, 2001). That proposition is surely absurd, and no authority is cited. If a simple interest in the potential precedential value of a case were sufficient to confer standing, there would be no effective restriction whatever on who might serve as a Plaintiff.