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January 31, 2002


The opinion of the court was delivered by: James Robertson, United States District Judge.


Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq., requires that pesticide registrants report to the Environmental Protection Agency (EPA) on an ongoing basis "factual information regarding unreasonable adverse effects on the environment of [a] pesticide." FIFRA § 6(a)(2), 7 U.S.C. § 136d(a)(2). EPA interprets that directive to cover opinions regarding unreasonable adverse effects rendered by a registrant's employees or agents, and it has issued a regulation to that effect. 40 C.F.R. § 159.158(a). In this suit, the American Crop Protection Association and others challenge that regulation on two grounds: first, that requiring opinions to be reported is beyond the authority Congress gave the EPA to require the reporting of "factual information"; and, second, that to the extent the regulation requires registrants to report the opinions of non-testifying expert witnesses prepared in preparation of litigation, or of lawyers, it "undermines the availability of the work product doctrine and the attorney-client privilege to pesticide registrants," Pl. Mem. at 2, and is thus an unreasonable interpretation of the statute and contrary to law. I find, for the reasons set forth below, that EPA did not exceed its authority and that its interpretation of the statute is entitled to deference and reasonable. The order that accompanies this opinion accordingly denies plaintiffs' motion for summary judgment and grants the government's cross-motion except to the extent that that motion seeks an advance blanket ruling on lawyer-client privilege and attorney work product. No ruling is made on that issue, because this record presents no concrete claim of privilege or of work product protection.


A pesticide must be registered before being placed on the market. It will be registered only if EPA finds that it will "perform its intended function without unreasonable adverse effects on the environment." 7 U.S.C. § 136a(c)(5)(C). Registration is not the end of the regulatory process: a pesticide registration may be maintained only if it does not "generally cause[] unreasonable adverse effects on the environment." 7 U.S.C. § 136d(b). Congress gave the EPA authority to call for additional data as needed for the ongoing evaluation of pesticides. "If the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify existing registrants." The authority to call for more data has teeth: if a registrant fails to provide information requested about a pesticide, EPA must issue a notice of intent to suspend the pesticide's registration. 7 U.S.C. § 136a(c)(2)(B). The statute also imposes upon registrants a duty of self-reporting. If "at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator." FIFRA § 6(a)(2), 7 U.S.C. § 136d(a)(2). It is that requirement which gives rise to the dispute presented in this case.

The dispute between pesticide manufacturers and the EPA about reporting has been going on for more than twenty-six years.*fn1 EPA's first regulation under section 6(a)(2) required registrants to report any information about adverse effects, 40 Fed. Reg. 28242, 28277 (July 3, 1975). EPA revoked that regulation in 1978, after concluding in response to an industry challenge that it "inadequately expresse[d] the agency's interpretation of the requirements imposed by FIFRA Section 6(a)(2)." 43 Fed. Reg. 37610 (Aug. 23, 1978). EPA then issued an "interpretive memorandum" setting forth its view that the statute required registrants to report opinions, including expert opinions, as to the risks or benefits of registered pesticides. An industry challenge to that memorandum was dismissed for lack of standing, upon a finding that the memorandum had no legal effect, Chemical Specialties Mfrs. Ass'n v. United States EPA, 484 F. Supp. 513, 519 (D.D.C. 1980) (Robinson, J.). The judge nevertheless volunteered his view that a requirement to report expert opinions would exceed EPA's authority: "If Congress had intended to give § 6(a)(2) such broad scope, it would not have limited the information required to facts." Id. at 518.

EPA tried again in 1985. This time it issued a proposed interpretive rule and statement of policy that required the reporting of expert opinions. The preamble to this rule stated that "EPA and the Department of Justice believe that EPA is free to take the position that expert opinion evidence . . . [is] covered by Section 6(a)(2) despite the dicta in CSMA, and EPA continues to take this position." 50 Fed. Reg. 38115, 38116 (Sept. 20, 1985). After receiving comments, however, the agency decided not to make the rule effective after all, stating that "clarification of the rule was appropriate." 57 Fed. Reg. 44290-91 (Sept. 24, 1992).

Finally, EPA resorted to formal notice and comment rulemaking. The present rules implementing FIFRA section 6(a)(2) are the result of that process. 40 C.F.R. Part 159, 62 Fed. Reg. 49370 (Sept. 19, 1997). Since their effective date in August 1998, they have required that a registrant report information, possessed or received, that is "relevant to the assessment of the risks or benefits" of pesticide registrations, if the information falls within any of seven enumerated categories, 40 C.F.R. § 159.158(a),*fn2 or if the registrant "knows or reasonably should know" that the information might raise "concerns" with the EPA about the continued registration of the product. 40 C.F.R. § 159.195.

The information that must be reported includes "conclusion(s) or opinion(s) rendered by a person who meets any of the following: (1) Who was employed or retained (directly or indirectly) by the registrant, and was likely to receive such information. (2) From whom the registrant requested the opinion(s) or conclusion(s) in question. (3) Who is a qualified expert as described in § 159.153(b)."*fn3 40 C.F.R. § 159.158(a) A registrant need not submit clearly erroneous information, previously submitted information, publications available to the agency, and information about eliminated inert compounds.

§ 159.158(b).

After plaintiffs instituted this action, EPA let it be known that it would not consider attorneys' legal theories to be information relevant to the assessment of risks and benefits, Pesticide Registration Notice 2000-8. EPA insists nevertheless that it "has no intention to broadly exempt information covered by the attorney work-product doctrine," 62 Fed. Reg. 49377, and that "[a]ttorneys' opinions are reportable . . . when they are developed in the ordinary course of business and are based on otherwise reportable information," Def.'s Mem. at 25 n. 16. EPA offers registrants the opportunity to request a waiver, which it says it will evaluate giving consideration to claims of privilege or of substantial prejudice to the registrant and the value of the information to EPA in performing its risk/benefit analysis. 62 Fed. Reg. 49377. No registrant has ever availed itself of that opportunity.


Judicial review of EPA's interpretation of the statute is accomplished according to the two-step approach set forth in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-43 (1984). A court must first ask if the statute is clear and unambiguous. If it is, the language of the statute controls. Id. "[I]f the statute is silent or ambiguous with respect to the specific issue," however, then "the question for the court is whether the agency's answer is based on a permissible construction of the statute." Id. at 843.

In this case, the first Chevron step is a short one, for the statutory words "factual information" are not unambiguous. The line between facts and opinions is fuzzy, and the distinction, "at best, one of degree." Beech Aircraft Corp. v. Rainey, 488 U.S. 153, 167 (1988); see also United States v. Pierson, 503 F.2d 173, 176 (D.C. Cir. 1974); Wigmore, Evidence § 1919, at 14-15 ("[N]o such distinction is scientifically possible. . . . Nearly everything which we choose to call `fact' either is or may be only `opinion' or inference."). Expert witness reports typically contain both data and conclusions. The existence of an opinion may be said to be a fact. As the EPA stated in its original interpretive notice, at least "[o]ne dictionary defines `factual' as `of or containing facts'" and information as "something told; news; intelligence, word." 43 Fed. Reg. 37611, 67613 (Aug. 14, 1978); see also American Heritage Dictionary (3d Ed. 2000) (defining "factual" as "of or containing facts"). It is clearly true, as EPA states in its preamble to the regulations, that "a conclusion as to whether a particular growth seen in a sacrificed test animal is a benign or malignant growth is not a matter of uncontestable fact, but rather, is the expression of an informed judgment by a trained professional." 62 Fed. Reg. at 49378. Information to the effect that a pathologist has seen lesions on slides and thinks they are malignant is surely "factual information." Information that a toxicologist thinks the malignant lesions were caused by exposure to a pesticide is surely "factual information."

Chevron's second question is "whether the agency's [interpretation] is based on a permissible construction of the statute." Chevron, 467 U.S. at 843. The agency's interpretation is entitled to ordinary deference,*fn4 and will be given "controlling weight unless [it is] ...

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