Opinion ID: 1161575
Heading Depth: 3
Heading Rank: 1

Heading: The EPA's postregistration consideration of efficacy

Text: Before granting registration, the EPA is required by FIFRA to determine whether a pesticide will perform its intended function without unreasonable adverse effects on the environment (§ 136a(c)(5)(C)), which means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide (§ 136(bb)). The term environment is defined to include all plants (§ 136(j)), and this definition includes crops (see Kuiper v. American Cyanamid Co., supra, 131 F.3d at p. 664). The 1978 amendment to FIFRA allows the EPA, [i]n considering an application for the registration of a pesticide [to] waive data requirements pertaining to efficacy. (§ 136a(c)(5).) However, in promulgating the waiver, the EPA emphasized that in the event that efficacy-related problems developed after a pesticide was registered, the agency would require and review such data. The Administrator reserves the right to request submission of efficacy data in support of label claims for any registered product. A request may be made for any product for which a pattern of inadequate performance has been reported. (44 Fed.Reg. 27932, 27939 (May 11, 1979); see 40 C.F.R. § 158.640(b) [EPA reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.].) Along the same lines, the EPA subsequently explained that without initial product performance data, the Agency is compelled to monitor more closely the content of use directions on labels.... If a pattern of inaccurate, outdated, or ambiguous use directions is determined to be a major problem, the Agency will require the submission of efficacy data. (49 Fed.Reg. 37960-37961 (Sept. 26,1984).) The EPA's recent adverse effects reporting rule (§ 136d(a)(2)) requires pesticide manufacturers to submit toxic or adverse effect incident reports, specifically including data concerning alleged effect[s] involving] damage to plants. (40 C.F.R. § 159.184(c)(5)(iv) (1999).) Significantly, the regulation provides that information need not be reported for an incident which concerns non-lethal phytotoxicity to the treated crop if the label provides an adequate notice of such a risk. (40 C.F.R. § 159.184(b)(4), italics added.) Moreover, upon receiving crop damage reports under the adverse effects reporting rule, the agency's regulatory options are not limited to cancellation; it can also require labeling changes. The EPA explained when it promulgated the rule that, [w]hile reportable information under section 6(a)(2) could conceivably result in cancellation ... action, this information could also be used by the Agency in other ways. The information could suggest the need for modification to the terms and conditions of registration which could be necessitated by the balancing of the risks and benefits associated with a particular pesticide. (42 Fed.Reg. 49370, 49372 (Sept. 19, 1997).)