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March 12, 1991


Royce C. Lamberth, United States District Judge.

The opinion of the court was delivered by: LAMBERTH


 This case comes before the court on defendant's motion for summary judgment and plaintiffs' cross-motion for summary judgment. After consideration of the motions, the oppositions, and reply memoranda, and the record herein, defendant's motion for summary judgment is granted and plaintiffs' motion for summary judgment is denied.



 Tributyltin ("TBT") is a compound belonging to the organotin (organic tin) family. Used as an ingredient in marine antifouling paint, TBT repels and retards the growth of barnacles, algae, and other encrusting organisms that create resistance on the bottom of marine vessels, reducing vessel speed and fuel efficiency. The benefits of TBT-based antifoulants are not, however, without cost. Studies show that even at low concentrations, TBT compounds are toxic to nontarget marine and freshwater organisms. *fn1"

 On March 22, 1989, the EPA issued a Data Call-In (DCI) notice to all TBT manufacturers and antifoulant paint suppliers requiring compliance with a ten year TBT monitoring program. The program requires current TBT marine antifoulant paint registrants to conduct extensive sampling of sediment, water, and aquatic organisms. Compliance with the DCI is an express condition of continued registration.

 On November 21, 1990, after a year and a half of negotiations with the EPA, plaintiffs *fn2" filed this suit and a motion for preliminary injunction challenging the lawfulness of the DCI. Following a hearing before the court, plaintiffs withdrew their preliminary injunction motion after the court set an expedited schedule for consideration of dispositive motions and defendant delayed action until this court's ruling. The court now considers both parties' motions for summary judgment.


 TBT sale and use is governed by two statutes, one generally applicable to pesticides and one specific to organotin compounds. The first, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136 - 136y (1988), requires the registration of all pesticides sold or distributed in the United States. 7 U.S.C. § 136a(a). In order to register, the applicant must demonstrate that the product can be used without causing "unreasonable adverse effects on the environment" 7 U.S.C. 136a(c)(5)(D), which is defined as without causing "any unreasonable risk to man or the environment, taking into account the economic, social and environmental costs and benefits of the use of any pesticide." 7 U.S.C. § 136(bb). In order to meet this burden, FIFRA requires applicants to file with the EPA sufficient data to allow the Agency "to make regulatory judgments about the risks and benefits of various kinds of pesticide products." 40 C.F.R. § 158.20(b)(1) (1990).

 Under FIFRA, EPA may also require "additional data" to support existing registrations of pesticides. 7 U.S.C. § 136a(c)(2)(B)(i). To collect this additional information, the EPA issues to current registrants a Data Call-In Notice (DCI) which requires the registrant to produce within 90 days evidence that it is taking steps to gather the requested information. 7 U.S.C. 136a(c)(2)(B)(ii). If the registrant fails to take appropriate steps within the designated time frame, the EPA may issue a notice of intent to suspend the registration. 7 U.S.C. § 136a(c)(2)(B)(iv). The proposed suspension becomes final after 30 days from receipt of the notice of intent to suspend unless the registrant requests a hearing within that period. Id. At the hearing, the validity of the additional data requirement may not be challenged: the only matter for consideration is "whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required." Id.

 The second regulatory statute governing TBT, the Organotin Antifouling Paint Control Act (OAPCA), 33 U.S.C. §§ 2401 - 2410 (1988), was enacted in June, 1988 to address environmental concerns about the effects of TBT. OAPCA requires the EPA to certify that antifouling paints on the market containing organotin have release rates at or below 4.0 micrograms per square centimeter per day *fn3" and specifically bans the use of the paints on vessels less than 25 meters in length. *fn4" In addition to restrictions on the kinds of paints permitted and their use, OAPCA imposes on EPA a ten year TBT monitoring obligation *fn5" and requires the Navy to monitor on a periodic basis organotin levels in the home ports of any Navy vessel coated with antifoulant paint containing organotin. *fn6"

 TBT Special Review

 In January, 1986, prior to the enactment of OAPCA, EPA initiated a Special Review *fn7" of TBT antifoulant registrations. In a notice in the Federal Register, 51 Fed. Reg. 778 (1986), Joint Appendix (hereafter J.A.) 110 - 11, EPA cited toxicity studies on the effects of TBT on aquatic organisms and solicited comments on the risks and benefits of TBT use. The Federal Register notice also referred to a technical support document which stated that the EPA would issued a DCI under section 3(c)(2)(B) of FIFRA requiring, among other information, TBT environmental monitoring data. J.A. 101. The DCI was issued on July 29, 1986 and required all registrants of TBT antifouling paints and producers of the TBT active ingredients to provide "product chemistry data, ecological effects data, environmental fate data, TBT paint release rate data, worker exposure data, quantitative use and application data, and efficacy data." J.A. 421.

 In October, 1987, after consideration of the public comments received in response to the 1986 Federal Register notice, the EPA issued a Preliminary Determination to Cancel Certain Registrations of Tributyltin (PD 2/3) 52 Fed. Reg. 37,510 (1987), J.A. at 112 - 21. The Preliminary Determination proposed to cancel the registration of certain TBT products and deny the applications of new TBT registrants unless certain conditions were met. *fn8" At the same time, the Agency issued "Tributyltin Special Review Technical Support Document and a Draft Notice of Intent to Cancel," a compendium of the scientific and technical information supporting the Agency's preliminary conclusions. J.A. 122 - 290. The support document, in its final paragraph, referred to a Data Call-In Notice that "will be issued shortly requiring TBT registrants to conduct a three to five year monitoring study of U.S. waters which will provide information on the extent and levels of TBT concentrations in the aquatic environment and impact of TBT on indicator organisms in situ." J.A. 256.

 In June of the following year, Congress enacted OAPCA and announced standards and prohibitions on TBT use more stringent than those proposed in the EPA's PD 2/3. In October, 1988, EPA issued a Partial Conclusion of the Special Review, taking into consideration OAPCA's requirements and comments and data received during the Special Review process. 53 Fed. Reg. 39,022 (1988), J.A. 421 - 40. EPA concluded that it would cancel the registrations and deny applications for registrations of antifouling paints containing TBT unless the terms of OAPCA and certain additional labelling and use restrictions were met. J.A. 422, 436 - 38. In addition, section VII, "Future Activities Regarding Tributyltin Antifoulant Paints," emphasized the need for continued study of the environmental effects of TBT and mentioned that in addition to outstanding DCIs, the Agency would issue DCIs by late 1988 "which will require TBT registrants to conduct multiyear and multistate monitoring studies." J.A. 436.

 Development of Monitoring Data

 EPA efforts to develop a TBT data monitoring program began in late 1988. In November, 1988, EPA issued a 16 page TBT monitoring program entitled "Guidance for Protocol Development." J.A. 441 - 56. EPA sent copies of the document for comment to 37 parties, including members of the EPA, other federal agencies, state agencies, environmental groups, and universities. J.A. 457 - 61. Plaintiffs did not receive a copy of the proposal.

 On March 22, 1989, EPA issued a DCI notice instructing all TBT antifoulant registrants to provide within 90 days written commitment to perform ten year monitoring studies on TBT levels in seven regions nationwide. The DCI required sampling from different sites within each region, the establishment of several monitoring stations within each site, and testing of water, sediment, and tissue. J.A. 509 - 539. The introduction to the DCI cautioned that "If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its requirements, or ...

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