30 ELR 10125 | Environmental Law Reporter | copyright © 2000 | All rights reserved
Leveling the FIFRA Playing Field: Life Beyond TermilindLynn L. Bergeson and Lisa M. CampbellThe authors are founding shareholders of Bergeson & Campbell, P.C., a Washington, D.C., law firm specializing in chemical product approval and regulations and other environmental and occupational safety and health law and business matters. The firm is outside counsel to Amvac Chemical Corporation and represented Amvac in the Termilind matter.
[30 ELR 10125]
The quest by law abiding pesticide registrants for relief from illegally registered pesticides has taken a new turn. Tacitly acknowledging the futility of urging the U.S. Environmental Protection Agency (EPA) to initiate enforcement action against bad actors, registrants are now, in epidemic proportion, taking their case to EPA in the form of filing administrative petitions to revoke and/or cancel Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)1 registrations issued to competitors and alleged to be obtained illegally. EPA's Offices of General Counsel and Pesticide Programs struggle on a good day to keep up with the relentless demands of implementing the Food Quality Protection Act (FQPA)2 and the day-to-day business of FIFRA registration and reregistration. The administrative burden placed on EPA as a result of these petitions is further stressing a system that often appears on the brink of collapse. Nonetheless, the administrative petition process, albeit slow, frustrating, and costly for both EPA and registrants, at the least has the potential to provide the semblance of a level playing field. This Dialogue describes In re Termilind, a landmark EPA decision revoking two FIFRA registrations, its progeny, and the reasons why EPA must streamline its current system or identify a better one to address the problem of illegally registered pesticide products.
The Termilind Decision and Its Origins
In November 1997, EPA issued the Termilind decision revoking as void ab initio two end use pesticide registrations it had previously issued to Termilind, Limited, after finding that Termilind willfully misrepresented critical information to EPA to obtain those registrations.3 In addition to revoking the end use registrations, EPA announced its intent to initiate proceedings to cancel Termilind's related technical registration, based on EPA's finding that there is a corporate/registrant "fitness criterion" implicit in the FIFRA registration requirements.
Before Termilind, the perception of many in the agricultural chemical community, particularly those considered "primary," rather than "follow-on," or "me-too" registrants,4 was that no clear administrative mechanism, short of a cancellation proceeding, existed to address pesticide registrations obtained illegally, and that enforcement actions against the sale and distribution of such products were few and far between, particularly with respect to violations that EPA did not perceive as posing an immediate public health threat. The Termilind decision opened a floodgate of petitions to revoke other allegedly wrongfully obtained pesticide registrations. The decision provided what many in the agricultural chemical community believed was a much needed pathway to address scams that put illegal pesticides on the market at the expense of competitors, the public, and the integrity of the FIFRA registration program.
The Facts Leading to the Termilind Decision
In March 1996, EPA issued two end use registrations for formulated pesticide products containing naphthaleneacetic acid (NAA) to Termilind. To obtain these registrations, Termilind certified to EPA that it was using Amvac's registered technical NAA product to formulate those end use products and thus that it was eligible for the formulators' exemption from the otherwise applicable data requirements necessary to support a pesticide registration.5 At the time, [30 ELR 10126] Amvac was the sole registrant of NAA technical pesticide products in the United States.
When Amvac discovered that Termilind had falsely claimed to be using Amvac's technical product, Amvac immediately advised EPA that neither it, nor any of its distributors, had sold or provided Termilind with NAA and thus that Termilind's claim to the formulators' exemption was false. After repeated urging from Amvac, EPA Region 10 issued on July 3, 1996, a Stop Sale, Use, or Removal Order (SSURO) prohibiting the sale or distribution of Termilind's two end use NAA products. In issuing the SSURO, EPA Region 10 stated that it believed "that the supplier of [NAA] for the [end use products] is different than what was listed in [Termilind's] confidential statement of formula [CSF] for these products."6 For this reason, EPA Region 10 concluded that distribution or sale of these products was a violation of FIFRA § 12(a)(1)(C).7
Because Amvac believed that Termilind should not be permitted to continue to use registrations that it had obtained through false representations to EPA, it filed, on August 2, 1996, a petition to revoke Termilind's two end use NAA registrations, claiming that the registrations were issued based on "false certifications to EPA . . . that Termilind's two products would be formulated from Amvac's EPA-registered technical naphthalene acetic acid (NAA) and thus qualify for the formulators' exemption."8 Amvac stated that it was the sole U.S. source of registered technical NAA, and that although Termilind cited Amvac as its source of technical NAA in the registration materials submitted for the two products, neither Amvac nor any of its distributors had sold technical NAA to Termilind. Further, Amvac stated that neither it nor its distributors had discussed sales of technical NAA with Termilind.
While EPA was considering this petition, in late September 1996, Termilind obtained a technical registration for NAA products and amended its two end use registrations to reflect the new technical registration. Once Termilind obtained the new technical registration, EPA Region 10 lifted the SSURO.9 Amvac then submitted, in October 1996, a second petition to revoke Termilind's technical registration, as well as its two end use registrations. This petition asserted that "Termilind willfully misappropriated confidential business information [(CBI)] to obtain the Technical Registration."10 Among other allegations, Amvac asserted that in 1994, Amvac entered into an arrangement with Shin Young C-Tech Co., Ltd. (C-Tech), a South Korean company, and its U.S. agent, Inchema, whereby C-Tech/Inchema would manufacture technical NAA for Amvac. Amvac stated in the petition that it supplied CBI to C-Tech/Inchema for the purposes of carrying out this business arrangement. The CBI was the subject of a confidentiality agreement, pursuant to which C-Tech/Inchema was forbidden to disclose CBI to third parties for any purpose. It is this CBI that Amvac asserts Termilind misappropriated and submitted to EPA in support of its technical NAA registration.11
Termilind did not on its own respond to either petition. On December 6, 1996, EPA "invited" it to respond to both. After receiving and reviewing Termilind's response, EPA determined that further development of both legal and factual issues was warranted prior to issuing a decision. In January 1997, EPA sent an identical set of questions to both parties and invited each to respond. EPA issued its decision on November 19, 1997.12
The Termilind Decision
EPA's decision on Amvac's petitions reaches three significant conclusions. First, EPA revoked as void ab initio Termilind's two end use NAA products based on EPA's finding that the registrations would not have been issued but for Termilind's willful misrepresentations to EPA. Second, EPA announced its intent to initiate proceedings to cancel Termilind's technical NAA registration, based on Termilind's submission of "misleading materials in support of its applications for registration" of the end use products. In so doing, EPA interjected a corporate/registrant "fitness" criterion into the FIFRA registration requirements. Third, EPA found that for purposes of FIFRA § 6(a)(1)13 (the existing stocks provision), "there is no meaningful distinction between a revocation and cancellation" and, accordingly, that EPA may permit the continued sale, distribution, and use of a pesticide whose registration has been revoked.
[30 ELR 10127]
Revocation of End Use Registrations
EPA concluded that Termilind had willfully misrepresented the source of its technical NAA when it obtained its end use registrations. In stating this conclusion, EPA expressly noted the "quality of the evidence available" demonstrating Termilind's willful misrepresentations. This evidence included sworn statements of the parties submitted in the federal district court litigation proving that Termilind in fact willfully misrepresented the source of its NAA product as Amvac's product.14 EPA intended to send a clear signal that it would consider similar revocation actions only on the basis of strong evidence.
EPA next analyzed whether EPA had authority under FIFRA to revoke, as opposed to cancel or suspend, a FIFRA registration. Amvac argued that EPA has inherent authority to revoke a registration, as does any agency, where the registration is based on willful misrepresentation. Amvac relied upon a wealth of case law acknowledging a tribunal's inherent power, whether judicial or administrative, to correct its own errors or modify its own judgments.15 Amvac also relied upon EPA precedent. In two prior instances, EPA has found that registrations obtained through misrepresentation are not valid when granted.16
Termilind argued that revocation is the equivalent of cancellation and thus can only be effectuated through a FIFRA § 6(b) cancellation proceeding. Termilind also contended that EPA does not have authority to revoke registrations obtained through fraud or misconduct because FIFRA does not explicitly provide such authority.
EPA rejected both of Termilind's arguments. With respect to the § 6(b) argument, EPA stated that "we find it implausible that Congress intended applicants who obtained registrations through fraud to receive the procedural protections of section 6." In response to the assertion that FIFRA does not authorize EPA to revoke registrations, EPA stated that "agencies have inherent authority to redress fraud or misrepresentation."17 EPA further found this conclusion consistent with its statutory authority under FIFRA to protect human health and the environment from the potential unreasonable adverse effects of pesticide use:
In order to protect the integrity of the FIFRA process and the safety of pesticide users and the public, the Agency must have a swift and sure method of responding when the submission of fraudulent or misleading application materials is discovered. If unscrupulous applicants receive the same procedural protections as honest ones, there is little incentive to be honest. Instead, the dishonest applicants who obtain speedy registration through fraud or misrepresentation are rewarded for their deception. Such an interpretation of FIFRA is contrary to the EPA's mandate to protect public health and the environment.18
Fitness Criterion for Pesticide Registrants
EPA denied Amvac's petition to revoke Termilind's technical registration, "on the basis that, beyond its role in resolving data compensation disputes, the Agency has neither the expertise nor the jurisdictional competence to adjudicate complicated issues regarding ownership of intellectual property rights."19 EPA stated, however, that it planned to initiate FIFRA § 6 cancellation proceedings with respect to the technical registration on an alternative "fitness" basis. EPA stated that the "fitness" or "reliability" of an applicant is "a component of the 'unreasonable adverse effects' standard."20 EPA explained:
Prior to granting a registration, the Agency is required to determine that a pesticide will not "generally cause unreasonable adverse effects on the environment" when used in accordance with widespread and commonly recognized practice. 7 U.S.C. 136a(c)(5). As a practical matter, in making such a determination the Agency must rely on data and certified statements submitted by the registrant. The Agency's ability to make an accurate finding is therefore directly related to the reliability of the material submitted. If the Agency knows that a registrant has a history of willful misrepresentation, the reliability of the materials submitted by that applicant is subject to question. The Agency's ability to make an accurate finding that the statutory standard for registration has been met is undermined under such circumstances.21
As support for its conclusion that a fitness criterion exists, EPA cited the general proposition that "fitness" to hold a "license or registration is recognized as a legitimate end of licensing schemes."22 EPA stated that its "ability to make an accurate finding that the statutory standard for registration has been met is undermined" when EPA knows a registrant has a "history of willful misrepresentation." A "fitness" or "reliability" criterion "can therefore properly be implied as a component of the 'unreasonable adverse effects' standard."23 EPA relied upon a well developed body of law holding that agencies are empowered to deny licenses on "fitness" grounds. Because EPA was "unable to rely on the veracity of unsubstantiated materials submitted by Termilind. . . . the Agency cannot affirmatively find that Termilind's technical product will not generally cause unreasonable adverse effects on the environment."24
The Termilind decision was the first case in which EPA applied this "fitness" criterion under FIFRA to revoke a registration.25 [30 ELR 10128] According to EPA, its inherent FIFRA authority is inextricably related to its statutory duty to find that,
a product will not cause unreasonable adverse effects before a registration may be granted. Common sense dictates that the Agency must be permitted to consider all relevant criteria when performing its analysis. As the discussion above illustrates, the integrity or reliability of a registrant is highly germane to the Agency's ability to make an accurate finding; if the Agency has reason to suspect that materials submitted by a registrant are untrustworthy, an affirmative safety finding cannot be made.26
EPA's inability to make precisely this finding regarding Termilind's technical registration led EPA to announce its "intention to undertake a section 6 cancellation of Termilind's technical NAA product in separate proceedings."27
Existing Stocks of Revoked Product
An important aspect of the Termilind decision is EPA's disposition of "existing stocks" of the revoked NAA product. In its petitions, Amvac urged EPA to disallow the sale, distribution, and use of existing stocks of any revoked product. Amvac argued that pesticide products whose pesticide registration had been revoked are, by definition, unregistered pesticides and not legitimate "existing stocks" at all.
EPA disagreed. EPA reasoned that for purposes of FIFRA § 6(a)(1), there is "no meaningful distinction" between a revocation and a § 6 cancellation. It stated that a determination otherwise "would leave the Agency essentially powerless to effectively condition the use of existing stocks (even if such conditions were necessary to prevent unreasonable adverse effects on the environment) . . . ."28 EPA declined to interpret FIFRA "in a manner that would suggest that Congress intended to give the Agency the authority to terminate registrations without giving the Agency authority to deal with the existing stocks consequences of such terminations."29
EPA's primary argument is that unless a revocation is a cancellation for purposes of FIFRA § 6(a)(1), EPA is without authority to regulate existing stocks of revoked pesticide product. There are strong counters to this assertion, however. As a threshold matter, EPA need not rely upon FIFRA § 6(a)(1) because product subject to a registration that never legitimately existed is by definition not legitimate "existing stocks." Additionally, EPA has clear authority under FIFRA § 13 to stop the sale and/or use of the revoked pesticide product.30 EPA has authority under FIFRA to order a product recall, the cost of which properly would be borne by the bad actor thus ensuring that the interests of the "relatively innocent" parties EPA seems so concerned about protecting are not compromised. The Agency's discussion of existing stocks in Termilind appears to support this interpretation. EPA stated:
In general, where the Agency revokes a registration because of misconduct involved in its inception, the Agency believes it inappropriate to allow the company involved in the misconduct to derive any benefit from its actions. The only way for the Agency to maximize the likelihood that Termilind will not profit at all from its actions is to prohibit all sale and distribution of the revoked products.31
Implications and Aftermath of the Termilind Decision
A Floodgate of Petitions and Potential for Strong EPA Action
Of the three key aspects of the Termilind decision—i.e., the decision to revoke, the incorporation of a "fitness" criterion into the registration requirements, and the conclusion that a revocation is effectively a cancellation for purposes of addressing existing stocks of product—the first two have had the most impact. Since EPA issued the decision, it has received numerous revocation petitions. As of December 1, 1999, EPA had 37 pending petitions for cancellation, revocation, or denial based on claims relating to data compensation or alleged illegal acts. The courts have also been the recipients of claims similar to those Amvac made against Termilind.
One recent example that has received attention in the trade press is the claim by United Phosphorous that BASF's crop protection subsidiary, Micro-Flo, imported millions of pounds of product bearing labels that falsely claimed EPA registration. The basis for the claim is United's assertion [30 ELR 10129] that Micro-Flo obtained and used United's proprietary data, under false pretense, to register its own pesticide products with EPA. United asserts that using United's data, Micro-Flo certified to EPA that the pesticides at issue would be produced by United. United further asserts that Micro-Flo then used the registrations EPA granted based on that certification to import different, unapproved products from producers other than United. United asserts in addition that the unapproved products imported by Micro-Flo had different compositions than United's products, compositions that were unapproved by EPA. United filed a complaint in late October 1999, making these allegations in the U.S. District Court of Delaware. The complaint seeks an estimated $ 56 million in damages. Although counsel for United is not at liberty to disclose whether a petition for revocation has been filed with EPA, it is likely United chose to pursue this administrative avenue, particularly given the similarity of the allegations in the complaint to those that formed the basis of the Termilind revocation.
Although there has been much activity from registrants in filing petitions with EPA, EPA has not, to date, publicly released any additional decisions to revoke a pesticide registration. EPA is actively considering such petitions, however, and is likely on the verge of granting at least one other such petition.
The clear statement of the fitness criterion for obtaining and maintaining pesticide registrations—the second key component of the decision—is a potentially strong tool for EPA to use to eliminate those who have a proven track record of misfeasance and fraudulent representations to EPA. Whether EPA will use this tool often or strongly remains to be seen, however, since EPA has not acted on the petitions it has received. In any event, industry has, and will continue to assert it.32
Little EPA Action and a Process That Needs to Be Fixed
In issuing the Termilind decision, and in its consideration of other revocation petitions it has received, EPA has established an elaborate administrative process, quite similar to the one that it has developed to consider petitions to cancel registrations. This process affords considerable opportunity for the registrant whose registration is subject to the petition to respond to the allegations. It also has resulted in considerable delay in EPA's decisionmaking process, a fact that is infinitely frustrating to the petitioners, who believe that the registrations subject to their petitions are illegal and should be removed immediately from the marketplace of legitimate competitors.
In the Termilind proceeding, Amvac originally did not serve copies of its petitions on Termilind, asserting that because the registrations were legally void ab initio, there was no right to notice or an opportunity to be heard. EPA disagreed with this assertion and established a process for Termilind to assert its case. EPA sent copies of the petitions to Termilind. When Termilind did not respond on its own initiative, EPA invited it to do so. After reviewing Termilind's response, EPA determined that additional factual development was necessary for it to reach a decision and asked both parties to respond in writing to a written set of questions. That letter also established procedures that the parties were to follow through the remainder of the proceeding. These procedures were intended to avoid what EPA characterized as ex parte contacts by either party to EPA regarding the matter. They consisted of requiring substantive communications on the petitions to be made in writing to EPA, with written copies served on the opposing party. All written submissions were required to include a certification that a copy had been served on the opposing party. Oral communications could take place only if the opposing party also participated or gave permission for the communication without its participation.
EPA has adopted these procedures in subsequent proceedings. It has required that petitions for revocation be served on the opposing party and has generally allowed a 60-day period for the opposing party to respond to the petition, just as the regulations provide for responses to petitions to cancel or deny registrations.33 EPA has expressly requested that submissions concerning the petition at issue be in writing, be served on the opposing party, and include a statement that the opposing party has been served. It additionally has required any oral communications to include representatives of both parties and, further, to be subsequently memorialized by a joint memorandum of telephone conversation signed by both parties and submitted to EPA.34 EPA also has discouraged CBI submissions, while at the same time setting forth procedures for the submission of such information.
Many argue that the procedures that EPA has developed for considering revocation petitions—which are nowhere established in any regulations—are unnecessary and inconsistent with the definition of a revocation. That is, if the facts demonstrate that a registration never actually existed because it was obtained through willful misrepresentations, then its owner cannot claim any procedural rights attendant to maintaining that registration. The fact that EPA has developed these procedures on an ad hoc basis, without establishing them pursuant to rulemaking procedures, is viewed as support for the conclusion that there is no legal basis for imposing or requiring such procedures.
Regardless of the merits of these arguments, many are frustrated with the delays associated with the procedures EPA has imposed, because they allow products that they believe are illegitimately and illegally in the marketplace to remain there for a significant period of time and the registrants of those products to profit accordingly. There is at least one instance in which EPA has issued proposed findings of fact on a petition for revocation that clearly conclude the registration [30 ELR 10130] was obtained illegitimately. EPA asked for the opposing party's input on these fact findings, even though the findings were based on previous submissions of that party, as well as the other party. To date, despite findings that unequivocally demonstrate that the product is illegally in the marketplace, EPA has neither revoked that registration nor issued an SSURO. The public health implications of this process are enormous. EPA should not, although this seems to be the case, elevate procedural due process rights above the public's right to insist upon being protected from unlawfully marketed pesticides.
Conclusion
The Termilind decision provides a clear pathway forward for registrants to address the bad actors in the pesticide market. Many have apparently followed this path, but have been met with delay on EPA's part in considering the merits of theircase. This is immensely frustrating to many in industry. A product subject to a registration that is void ab initio should never have been in the marketplace, a fact that supports immediate EPA action to remove such product from the marketplace. Yet, the administrative processes that EPA has established to govern its consideration of revocation petitions has produced a backlog of petitions and little decisive action on EPA's part. In its effort to ensure that it does not mistakenly revoke a properly obtained registration and to ensure that it carefully considers all of the facts pertinent to a particular case, EPA has established procedures that prevent it from taking immediate action or indeed any action within a predictable time frame. The processes that EPA has established can work, however, if the time frames are made clear, predictable, and tight and if EPA sets and keeps deadlines for its own deliberative process. Whether EPA has the interest or resources in undertaking the effort to ensure this happens is unclear.35 If EPA views a product subject to an ill-gotten registration as a potentially devastating public health and safety threat—as many believe it should—EPA should make as a top priority the streamlining of the revocation petition process so that it results in decisive EPA action within predictable time frames.
1. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-34.
2. Pub. L. No. 104-170, 110 Stat. 1489 (1996).
3. 62 Fed. Reg. 61890 (Nov. 19, 1997) (Notice and Order of Revocation of Registrations and Final Determination Governing Sale and Use of Existing Stocks).
4. Pesticide registrations are in two main forms. The technical grade of an active ingredient is generally registered by the manufacturers of the molecule who also support the registration by satisfying demanding testing requirements specific to the ecological, environmental fate, and mammalian effects of the compound, as well as certain efficacy requirements, as required under FIFRA. "Primary registrants" are thus those that have registered the molecule and own the data supporting the registration or subsequently purchased the data from others who have registered the molecule. Registration of the pesticide product that is identical or nearly identical to a pesticide that is already registered by citing the primary registrant's data is called a "me-too" registration. Me-too applications take considerably less time for EPA to process, thus enabling "follow on" registrants to enter the market quickly.
5. A registrant can fulfill its obligation to submit much of the data required for registration by formulating its product with an existing registered pesticide purchased from another producer. See 7 U.S.C. § 136a(c)(2)(D), ELR STAT. FIFRA § 3(c)(2)(D); 40 C.F.R. § 152.85 (1998) (formulators' exemption). The premise behind the formulators' exemption is that the purchase price of the registered material compensates the original registrant for the cost of data generation. FIFRA § 3(c)(2)(D) provides:
No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into the pesticide that is the subject of the application shall be required to—
(i) submit or cite data pertaining to such purchased product; or
(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.
40 C.F.R. § 152.85 reads as follows:
(a) FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to the safety of any ingredient (or mixture of ingredients) contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another producer.
(b) If the product contains one or more ingredients eligible for the formulators' exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirements pertaining to the safety of any such ingredient, provided that he submits to the Agency a certification statement containing the following information . . .:
(1) Identification of the applicant, and of the product by EPA registration number or file symbol;
(2) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient;
(3) A statement that the listed ingredients meet the requirements for the formulators' exemption;
(4) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula; and
(5) The name, title and signature of the applicant or his authorized representative and the date of signature.
(c) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.
6. Letter from M. Jennings, Chief, Pesticides Unit, EPA, to J. Fitzsimmons, President, Termilind, Ltd. (July 3, 1996).
7. FIFRA § 12(a)(1)(C) makes unlawful the sale or distribution of "any registered pesticide the composition of which differs at the time of its distribution or sale from its composition as described in the statement required in connection with its registration under [§ 3]." 7 U.S.C. § 136j(a)(1)(C), ELR STAT. FIFRA § 12(a)(1)(C).
8. 62 Fed. Reg. at 61891.
9. EPA Region 10 later sent Termilind a Warning Letter, mailed on Dec. 16, 1996, in which it confirmed its conclusion that a violation of FIFRA § 12(a)(1)(C) had occurred.
10. Id.
11. During the same time period, Amvac initiated legal proceedings against Termilind in the U.S. District Court for the District of Oregon, seeking, among other relief, damages for Termilind's misappropriation of Amvac's data.
12. 62 Fed. Reg. at 61890.
13. 7 U.S.C. § 136d(a)(1), ELR STAT. FIFRA § 6(a)(1).
14. 62 Fed. Reg. at 61893.
15. Alberta Gas Chems., Ltd. v. Celanese Corp., 650 F.2d 9, 13 (2d Cir. 1981) ("It is a well established principle that an administrative agency may reconsider its own decisions. . . . It is hard to imagine a clearer case for exercising this inherent power than when a fraud has been perpetrated on the tribunal in its initial proceeding." (citations omitted)). EPA cited precedent set forth in Amvac's petition. Id.; Trujillo v. General Elec. Co., 621 F.2d 1084, 1086 (10th Cir. 1980) ("Administrative agencies have an inherent authority to reconsider their own decisions, since the power to decide . . . carries with it the power to reconsider." (quoting Albertson v. Federal Communications Comm'n, 182 F.2d 397, 399 (D.C. Cir. 1950))).
16. In re Alfred Waldner Co., 59 Fed. Reg. 49395 (Sept. 28, 1994); In re Accufilter Int'l, Inc., 59 Fed. Reg. 60013 (Nov. 21, 1994) (notice and order of revocation of registrations).
17. 62 Fed. Reg. at 61893.
18. Id.
19. Id.
20. Id.
21. Id.
22. Id.
23. Id.
24. Id.
25. In this regard, the Termilind decision stands in stark contrast to EPA's decision in the I.Pi.Ci. case, where the "fitness" issue was raised, but decided differently. In that case, I.Pi.Ci. submitted a petition to EPA challenging issuance of a technical registration for trifluralin to Tri Corporation (TriCorp). The petition alleged that TriCorp had submitted materially misleading information with its application for registration, and requested, among other things, that EPA vacate or suspend and cancel TriCorp's registration. In response to the cancellation request, EPA noted that the petition raised a "corporate character" issue, and that,
while the Agency believes that under some circumstances corporate character issues could justify the denial of an application or cancellation of an existing registration, the Agency has never previously taken such a step and we would anticipate that such an action would not be immune from legal challenge. Given that any factual misstatements would be violations of FIFRA subject to civil and/or criminal enforcement under FIFRA section 12, the nature and extent of the alleged misstatements here, and that, as outlined below, the Agency has determined that it now has sufficient information from TriCorp in order to evaluate the chemical composition of its product, the Agency does not believe it appropriate in this particular case to pursue a cancellation case based upon corporate character issues.
Letter from R. Perlis. Office of General Counsel, EPA, to D. Robinson, Patton Boggs, and E, Ruckert, McDermott, Will & Emery (Jan. 18, 1996) at 4. In a footnote, EPA stated that:
indeed, if a registrant were found to lack sufficient corporate character in order for the Agency to make the necessary findings under FIFRA section 3, the remedy might well be to cancel all the registrations held by the registrant and to deny all applications from the company until such time as the character defect were demonstrably cured. Such an action would clearly have important consequences for a registrant, and the Agency does not believe such a step should be taken lightly.
Id. n.4.
26. 62 Fed. Reg. at 61893.
27. Id.
28. 62 Fed. Reg. at 61894.
29. Id.
30. FIFRA § 13 states that "whenever any pesticide . . . is found by [EPA] . . . in violation of any of the provisions of this [Act] . . . [EPA] may issue a written or printed 'stop sale, use, or removal' order . . . ." 7 U.S.C. § 136k(a), ELR STAT. FIFRA § 13(a).
31. 62 Fed. Reg. at 61895.
32. With regard to the third key component of the decision, EPA's application of the existing stocks authority to the revoked NAA product seems inconsistent with its goals in stating its revocation authority and the fitness criterion. If EPA seeks to send a message that noncompliance does not pay, it should prohibit, once a registration is revoked, the continued distribution, sale, and use of the revoked product. FIFRA's recall provisions are expressly designed to ensure that the cost of noncompliance is borne by the FIFRA violator. Only this interpretation of FIFRA ensures that bad actors do not profit from their misdeeds.
33. See 40 C.F.R. § 152.99(b)(2).
34. Interestingly, however, EPA has not required oral communications to include representatives of both parties when the subject of the discussion is a registration matter as opposed to a petition matter. In the Termilind case, for example, representatives from Termilind engaged EPA registration representatives in countless conversations and meetings regarding registrations for the very products at issue in the revocation proceeding. EPA's willingness to separate the revocation proceeding from the registration process under these circumstances was both legally indefensible and somewhat mystifying.
35. EPA announced on Dec. 2, 1999 its plans to focus on "bootleg" active ingredients unlawfully used in product formulations. See Daily Env't Rep. (BNA), Dec. 6, 1999, at A-10. How serious EPA is in this regard, and exactly how it intends to step up its enforcement efforts is unclear. It is, however, a step in the right direction.
30 ELR 10125 | Environmental Law Reporter | copyright © 2000 | All rights reserved
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