Opinion ID: 1161575
Heading Depth: 2
Heading Rank: 4

Heading: The EPA's Waiver of Submission of Efficacy Data in Registering Pesticides

Text: After we granted review, the United States filed an amicus curiae brief on behalf of plaintiffs. Even though the question presented in this case has been addressed by nine of the federal circuit courts of appeals, the United States failed to file amicus curiae briefs in any of the cases and permitted those courts to proceed upon a fundamental assumption that it now characterizes as mistaken. According to the EPA, the courts that have reached the conclusion that FIFRA preempts state failure-to-warn claims have done so under the mistaken impression that FIFRA regulates all aspects of pesticide labeling. In fact, with congressional approval, the EPA concerns itself only with whether a pesticide would have unreasonably adverse effects on human health or the natural environment. In initially registering a pesticide, the EPA does not address the question whether it will control the target pest or harm the crop it was intended to protectthe claim made here. Those are questions of pesticide efficacy. Congress gave the EPA authority to waive the review of pesticide efficacy claims, and the EPA has exercised this authority, leaving it to the marketplace and the prospect of tort liability to fill the gap. Therefore, the maintenance of state failure-to-warn claims, the United States argues, is entirely consistent with FIFRA as it is actually administered by the EPA. The factual support for the foregoing characterization of the pesticide registration and label approval process, the United States submits, is supplied by a document issued by the EPA's Office of Pesticides Programs, Pesticide Regulation (PR) Notice 96 (June 3, 1996). Notice will be taken of PR Notice 96-4 as an official act of the federal government within the meaning of Evidence Code section 452, subdivision (c). (See Empire Properties v. County of Los Angeles (1996) 44 Cal.App.4th 781, 788, fn. 2, 52 Cal. Rptr.2d 69 [notice taken of report of task force commissioned by the Legislature]; San Mateo County Coastal Landowners'1 Assn. v. County of San Mateo (1995) 38 Cal.App.4th 523, 552-553, 45 Cal.Rptr.2d 117 [trial court properly took notice of letter from the Secretary of Resources to the Executive Director of the California Coastal Commission]; People v. Goodloe (1995) 37 Cal.App.4th 485, 493-494, 44 Cal. Rptr.2d 15 [notice taken of Department of Corrections' administrative bulletin].) The gravamen of PR Notice 96-4 is that the courts reaching the conclusion that FIFRA preempts state failure-to-warn claims have done so under the mistaken impression that the EPA evaluates efficacy in the initial pesticide registration and label approval process. However, plaintiffs do not claim the pesticides they used were inefficacious, i.e., that they failed to control the target pests. Rather, they claim they should have been warned that the combined use of these pesticides could be phytotoxic, i.e., that they might damage the crop they were intended to protect. (This warning, that Morestan when combined with [Guthion] produces some phytotoxicity is totally missing from the label restrictions.) As defendants point out, the EPA's testing guidelines appear to make it clear that phytotoxicity and efficacy are distinct concepts and that, contrary to the implications of PR Notice 96-4 and assertions made in the briefs of plaintiffs and the United States, the former concept is not included in the latter. The EPA's testing guidelines for assessing a pesticide's potential hazards to nontarget plants, e.g., crops, define phytotoxicity as follows: The term `phytotoxicity' or `plant toxicity' means unwanted detrimental deviations from the normal pattern of appearance, growth, and function of plants in response to pesticides and to other toxic chemicals that may be applied with the pesticide. (EPA, Pesticide Assessment Guidelines, subd. J, Hazard Evaluation: Non-Target Plants (Oct.1982) § 120-2, p. 18.) A separate set of guidelines for assessing a pesticide product's performance states that [t]he term `effectiveness' ... is synonymous with the term `efficacy,' and defines `effectiveness' as follows: The term `effectiveness' refers to a product's ability to control the specific target pest ... when the product is applied in accordance with the label directions, precautions, and limitations of use. (EPA, Pesticide Assessment Guidelines, subd. G: Product Performance (Nov. 1982) § 90-2(b), p. 36.) The claim made in PR Notice 96-4 that the EPA does not concern itself with questions of efficacy in the initial pesticide registration and label approval processis thus beside the point. Phytotoxicity is not a matter of efficacy, and it is phytotoxicity of which plaintiffs complain. Nevertheless, we will proceed to consider the argument the United States makes on the basis of PR Notice 96-4, which may be summarized as follows: The 1972 amendments to FIFRA required the EPA to evaluate all claims of pesticide efficacy. (§ 136a(c)(5)(A).) However, as the House Agriculture Committee observed, the pesticide approval process then ground to a virtual halt. (H.R.Rep. No. 95-663, 1st Sess., p. 18 (1977) reprinted in 1978 U.S.Code Cong. & Admin. News at p. 1991.) In an effort to streamline the process, Congress amended FIFRA in 1978 to permit the EPA to waive review of pesticide efficacy claims. (7 U.S.C. 136a(c)(5).) The EPA issued such a waiver (40 C.F.R. §§ 158.640(b), 158.540 (1999)), explaining that it would enable the agency to focus on its primary mandate under FIFRA ... the health and safety aspects of pesticides (47 Fed.Reg. 53192, 53196 (Nov. 24, 1982)). Because the EPA does not review efficacy claims, the United States asserts, preemption of state damages actions challenging pesticide efficacy would leave such statements largely, or entirely, unregulated. Again, the short answer to this argument is that the EPA's waiver of the submission of efficacy data is irrelevant, since plaintiffs complain of phytotoxicity, not inefficacy. However, even assuming arguendo that phytotoxicity is included within the concept of efficacy, there remain two fundamental flaws in the argument that pesticide efficacy will go largely, or entirely, unregulated if state failure-to-warn claims are preempted: (1) Although the EPA has waived the submission of efficacy data for agricultural pesticides at the time of their initial registration, the agency does require and review such data if efficacy-related problems develop later; and (2) California has a comprehensive registration and regulatory program for pesticides, and while the California Department of Pesticide Regulation may not impose its own requirements for labeling, it can restrict or prohibit the sale or use of products that it determines are inefficacious or phytotoxic. (See § 136v(a).)
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).)
Congress, the United States asserts, did not intend to leave pesticide efficacy unregulated. On the contrary, Congress specifically sanctioned state regulation of pesticide efficacy. FIFRA clearly does contemplate a state/federal partnership in the regulation of pesticide efficacy and phytotoxicity. Section 136v(a) provides that a State may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this subchapter. This does not mean, however, that the regulation may be accomplished through the back door by means of tort suits that effectively require changes in EPA-approved labeling. California requires that pesticide manufacturers and their products be registered with the Department of Pesticide Regulation. (Food & Agr.Code, §§ 12811, 12993.) The code requires that a comprehensive risk/benefit analysis be undertaken in the public interest when the department considers whether a product should be registered in the first instance or whether its registration should be canceled. (Food & Agr.Code, §§ 12824, 12825; see also Cal. Code Regs., tit. 3, § 6158.) With regard to the specific claim made in this case, the department may require data on [p]hytotoxicity and [t]he effect from the use of mixtures of two or more products in combination. (Cal.Code Regs, tit. 3, § 6192, subds. (b), (e).) To ensure that California's agriculture is protected from unforeseen or newly discovered risks, the director is charged with the responsibility for the continuous evaluation of all registered products. (Cal.Code Regs, tit. 3, § 6226.) As part of this continuous evaluation, the director must make administrative determinations regarding precisely the issue raised by this case[u]ndesirable phytotoxicity. (Cal.Code Regs, tit. 3, § 6221, subd. (f).) Given the comprehensive and stringent character of California's program of pesticide regulation, having lay juries assess questions of phytotoxicity in the context of failure-to-warn claims is neither necessary nor desirable, and holding that such actions are preempted by FIFRA promotes federalism, rather than undermines it.