In the March 2010 issue of CropLife® (“Coming To A Head,” March 2010), we discussed the status of EPA’s Pesticide Drift Labeling Notice (PR Notice 2009-X), which was issued on Nov. 4, 2009. EPA issued PR Notice 2009-X to advance its goal of establishing clear and concise labeling statements that would ultimately lead to reduced off-target pesticide drift.
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EPA requested public comment on this notice and the time for submitting comments closed on March 5, 2010. An analysis of the comments submitted to EPA by the industry demonstrates that the regulated community has significant concerns with the most recent proposed drift labeling language.
The crop protection industry supports EPA’s general objective of reducing off-target pesticide drift while promoting consistency and clarity among pesticide labels, but the best path to getting there has been a point of debate.
The quest for comprehensive drift labeling actually dates back to 2001. EPA issued Draft Pesticide Registration Notice 2001-X: Spray and Dust Drift Label Statements for Pesticide Products (“PR Notice 2001-X”) to provide comprehensive guidance for pesticide drift labeling, with a focus on proposed changes to generic pesticide drift label language statements.
Many stakeholders submitted comments on a variety of aspects concerning PR Notice 2001-X. Ultimately, after EPA’s review of the public comments, draft PR Notice 2001-X was not finalized.
The issue was revisited with the development of PR Notice 2009-X, which took into account the public comments it received on draft PR Notice 2001-X. Once again, EPA requested and received numerous public comments urging it to either revise or withdraw the proposed labeling changes.
A review of the comments published to date indicate that industry stakeholders have substantial concerns about PR Notice 2009-X — specifically that it abandons the statutory language of the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), creates an unachievable zero drift policy, does not provide for any real risk assessment, and does not provide registrants with adequate time to implement the proposed label changes.
Many stakeholders are concerned that use of the proposed terms “could cause” or “may cause” deviate from the statutory standards set forth under FIFRA. Under FIFRA, the appropriate standard by which to evaluate pesticides is whether the pesticide causes an “unreasonable adverse effect.” FIFRA defines an unreasonable adverse effect as “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.”
By not using a risk-based approach to evaluate pesticides, EPA appears to be abandoning the “unreasonableness” aspect of potential drift effects. PR Notice 2009-X fails to account for the “economic, social, and environmental costs and benefits” of the use of pesticides. This proposed shift from “unreasonable adverse effects” to “could cause” adverse effects is problematic. The mere detection of the active ingredient of a pesticide at de minimis levels does not necessarily create any risk of an adverse event, or even indicate that the pesticides were misapplied.
Zero Drift Policy
FIFRA authorizes EPA to register pesticide products by engaging in a risk-benefit analysis for each pesticide submitted for registration. This analysis helps EPA determine, among other things, whether the pesticide label is appropriate. If, based on its risk assessment, EPA determines that the applicant-proposed labeling does not prevent unreasonable adverse effects from use of the pesticide, it may suggest revisions to the labeling.
EPA previously recognized that technology and methodology helping to prevent pesticide drift was continually improving, and that while responsible applicators try to control drift, “there will always exist controllable and uncontrollable factors which lead to drift, potential exposures, and risks of harm. The factors that contribute to drift are unique to each application and depend on weather, the application site, application equipment, and applicator behavior.”
The issue, according to stakeholders, is not whether a pesticide drifts — some level of drift will almost always occur. It is whether the drift presents “unreasonable adverse effects.” Under PR Notice 2009-X, EPA would apparently no longer engage in this type of FIFRA-mandated risk analysis. Instead, PR Notice 2009-X essentially sets up a “zero drift, zero exposure policy.”
In a letter to EPA, Rep. Collin C. Peterson (D-MN), chairman of the U.S. House of Representatives Committee on Agriculture, effectively captures this concern by stating that the current language “if left intact, would represent an extraordinary shift to a zero tolerance risk standard for off-target spray drift.” Such a shift is inconsistent with the risk standard established by FIFRA, he says. A “policy based entirely on exposure or the mere presence of a pesticide at any level is technically unachievable and inconsistent with EPA’s FIFRA mandate.”
Under a “zero drift” policy, a violation of the pesticide label would apparently occur whenever any drift contacts a non-target organism or site. Such a policy could cripple the ability of applicators to apply pesticides. The problematic nature of a zero drift policy was previously discussed by EPA when it acknowledged that “some de minimis level of drift would occur from most or all applications as a result of the uses of pesticides.” This is now truer than ever as technological advances allow for the detection of pesticides at extremely low rates, a fact that PR Notice 2009-X does not adequately take into account.
Time To Implement Changes
If EPA opts to not make any changes to PR Notice 2009-X and it is finalized as written, product labeling in compliance with PR Notice 2009-X must be submitted with the registration materials for any product not yet registered with EPA. Under the rules, registrants of existing products will have between six and 12 months to submit new general drift labeling statements to EPA.
Many stakeholders believe that this amount of time is insufficient and have requested a minimum of 24 months to comply with the requirements of PR Notice 2009-X. It is generally believed that two years is a more reasonable amount of time to review current labels and implement any newly required language.
EPA is again proposing revisions to the required pesticide drift language used on pesticide products. And once again, the public comments submitted by the agricultural industry illustrate some very real concerns. Specifically, stakeholders are concerned that the proposed language sets an unachievable standard, inconsistent with FIFRA’s risk-benefit approach, which may ultimately result in unwarranted litigation against growers, applicators, homeowners, and other regulated individuals. Whether EPA will heed these legitimate concerns is yet to be seen.