By James V. Aidala and Lisa R. Burchi

On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with the U.S. Environmental Protection Agency (EPA) to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides (Petition). The Petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition.

The Petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.

The Petition also states that EPA must take the following actions:

• Update EPA’s human health risk assessments (HHRA) for OP pesticides to use a regulatory endpoint that the Petition claims will protect children from learning disabilities and other neurodevelopmental harm.
• Complete Endangered Species Act (ESA) consultations and ensure its registrations comply with the ESA;
• Conduct endocrine disruptor screening of all pesticides.
• Complete a cumulative risk assessment for all the OPs to address their cumulative acute poisoning and neurodevelopmental effects.

The Petition focuses on 15 OPs that are currently going through registration review:

• Acephate (EPA-HQ-OPP-2008-0915);
• Bensulide (EPA-HQ-OPP-2008-0022);
• Chlorethoxyfos (EPA-HQ-OPP-2008-0843);
• Chlorpyrifos-methyl (EPA-HQ-OPP-2010-0119);
• Diazinon (EPA-HQ-OPP-2008-0351);
• Dichlorvos (EPA-HQ-OPP-2009-0209);
• Dicrotophos (EPA-HQ-OPP-2008-0440);
• Dimethoate (EPA-HQ-OPP-2009-0059);
• Ethoprop (EPA-HQ-OPP-2008-0560);
• Malathion (EPA-HQ-OPP-2009-0317);
• Naled (EPA-HQ-OPP-2009-0053);
• Phorate (EPA-HQ-OPP-2007-0674);
• Phosmet (EPA-HQ-OPP-2009-0316);
• Terbufos (EPA-HQ-OPP-2008-0119); and
• Tribufos (EPA-HQ-OPP-2008-0883).

Commentary

Now that EPA is in receipt of the Petition, it must determine that it has received a “complete” petition to revoke a tolerance based on criteria set forth in EPA’s regulations (40. C.F.R. § 180.7). If EPA determines the Petition is complete, it will publish in the Federal Register within 30 days a notice of filing for the Petition, which must include the informative summary of the Petition submitted by the petitioner. FFDCA Section 408(d)(3). A public comment period follows.

Generally, the Petition is an important signaling document that the petitioners use to outline how EPA should approach the 2022 registration review deadline for these OP products. It signals that unless EPA completes all elements of a registration review, including a complete ESA assessment and an endocrine disruptor review -- which may be impossible for EPA to complete -- then EPA should act now to revoke OP tolerances in light of arguments contained in the Petition. It stresses the environmental justice commitments announced by the Biden Administration, arguing that evidence is clear, in their view, of the need to take immediate action to end OP use across virtually all of the members of the class. It seems to anticipate that even if EPA rolls out registration reviews of the individual OP pesticides before the deadline, there will likely be comment and debate about the specific analyses and evaluation of each member of the category. This would additionally delay the completion of any revised cumulative risk assessment for the OPs.

From the view of the petitioners, not only will EPA miss the 2022 deadline, but they also argue the evidence is sufficient now for EPA to take action to revoke tolerances for these compounds based on evidence already before EPA. Other stakeholders and EPA’s eventual analyses will dispute such conclusions, but completing registration review (as defined in the Petition) will likely be impossible to complete before next October. As a result, the Petition here suggests the template these advocacy groups will use to challenge continued registration of OP products past the 2022 deadline.

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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced that it had reached an agreement with Monsanto, BASF, and DuPont on measures “to further minimize the potential for drift to damage neighboring crops from the use of dicamba formulations used to control weeds in genetically modified cotton and soybeans,” and “new requirements for the use of dicamba ‘over the top’ (application to growing plants) will allow farmers to make informed choices for seed purchases for the 2018 growing season.”

EPA states that in a series of discussions, it “worked cooperatively with states, land-grant universities, and the pesticide manufacturers to examine the underlying causes of recent crop damage in the farm belt and southeast,” “sought extensive input from States and [U.S. Department of Agriculture (USDA)] cooperative extension agents from across the country, as well as the pesticide manufacturers, on the underlying causes of damage,” and “reviewed all available information carefully and developed tangible regulatory changes for the 2018 growing season.”

The label changes that certain registrants of dicamba products have agreed to impose additional requirements for "over the top" use of these products next year.  These new requirements include:

• Classifying products as "restricted use," permitting only certified applicators with special training, and those under their supervision, to apply them; dicamba-specific training for all certified applicators to reinforce proper use;
• Requiring farmers to maintain specific records regarding the use of these products to improve compliance with label restrictions;
• Limiting applications to when maximum wind speeds are below 10 mph (from 15 mph) to reduce potential spray drift;
• Reducing the times during the day when applications can occur;
• Including tank clean-out language to prevent cross contamination; and
• Enhancing susceptible crop language and recordkeeping with sensitive crop registries to increase awareness of risk to especially sensitive crops nearby. 

This announcement follows two compliance advisories issued by EPA in August 2016 and July 2017 on what EPA described as the high number of complaints received regarding crop damage from the alleged misuse of herbicides containing the active ingredient dicamaba.  EPA’s August 2016 compliance advisory stated that the Missouri Department of Agriculture received 117 complaints alleging misuse of pesticide products containing dicamba, and Missouri growers estimated that more than 42,000 acres of crops had been adversely affected.  Further, that similar complaints alleging misuse of dicamba products were received by Alabama, Arkansas, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Tennessee and Texas.  In the spring of 2016, EPA issued a proposal to register dicamba to control weeds in cotton and soybean that have been genetically engineered to tolerate dicamba.  In November 2016, EPA issued a conditional registration for dicamba on dicamba-tolerant cotton and soybean to Monsanto for its Xtendimax product; and EPA recently approved a label amendment made by Monsanto for Xtendimax which includes “additional restrictions further minimizing off-field movement of the active ingredient dicamba.”

EPA’s July 2017 compliance advisory states that by early July, EPA had received reports of hundreds of complaints to state agencies in Arkansas, Missouri, and Tennessee, a significant increase from 2016; lists the three new conditional registrations issued late last year (including Xtendimax); and states that only these new registered products may be lawfully applied over-the-top of growing soybeans and cotton.  It discusses what it describes as unlawful applications of dicamba products, and states that “[e]xcept for the new conditionally registered dicamba products, application of a dicamba product during either the cotton or soybean crop growing season is unlawful under FIFRA.”

EPA’s July 2017 compliance advisory further states that each of the conditionally approved dicamba herbicide products has labeling that provides mandatory directions for use, restrictions, and special precautions that must be followed, and that the labels of the new products require specific and rigorous drift mitigation measures to further reduce the potential for exposure from spray drift including:

• No application from aircraft;
• No application when wind speed is over 15 mph;
• Application only with approved nozzles at specified pressures; and
• Buffer zones to protect sensitive areas when the wind is blowing toward them.

Commentary

The reports of and concerns about potential damage to crops in connection with the application of dicamba illustrate a problem that has long been discussed, which is the potential for unintended impact when a pesticide that has been specifically designed for use with one or more crops that have been genetically engineered to be tolerant to the pesticide is applied in close proximity to other crops that do not share these tolerant characteristics. 

The dicamba case also illustrates the differing views on potential misuse issues.  Some observers have questioned whether all of the reported dicamba incidents were due to misuse or misapplication of the product.  Although the 2018 label changes are designed to mitigate the potential for damage to sensitive crops, some question whether some unanticipated or as yet not completely understood factor may be at play in some of the incident reports.  One issue raised by some researchers concerns potential unexpected volatility of the product even when applied according to the label directions by well-trained applicators.  The registrants have disputed this suggestion, but it is an area which will likely be more thoroughly researched over the next few growing seasons.

More information on EPA’s regulatory action on dicamba is available on EPA’s website.

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By Lisa M. Campbell, James V. Aidala, and Carla N. Hutton

On March 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) sent a memorandum to Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), announcing that it plans to begin preliminary research to assess EPA’s management and oversight of resistance issues related to herbicide tolerant genetically engineered (GE) crops.  OIG states that its review will include the Office of Pesticide Programs (OPP), as well as other applicable headquarters and regional offices.  OIG’s objectives are to determine:

1. What processes and practices, including alternatives, EPA has provided to delay herbicide resistance;
2. What steps EPA has taken to determine and validate the accurate risk to human health and the environment for approved pesticides to be used to combat herbicide resistant weeds; and
3. Whether EPA independently collects and assesses data on, and mitigates actual occurrences of, herbicide resistance in the field.

OIG states that the anticipated benefit of the project “is a greater understanding of herbicide resistance[,] which will lead to an enhancement of EPA’s herbicide resistance management and oversight.”

Commentary

Pesticide resistance is not a new issue and is one that EPA has affirmatively addressed when granting registrations for new products, GE or not, for some time.  In fact, that newer chemistries often have a more niche mode of action to reduce potential toxicity concerns has led some observers to speculate that greater resistance is one potential trade-off for the development of less toxic materials.

This “investigation” may appear to some to be a response to concerns raised by critics of GE crops generally and to a recent EPA decision to approve Enlist Duo herbicide, a new formulation of 2,4,D- and glyphosate designed to address the problem of weed resistance to glyphosate-tolerant crops.  Glyphosate tolerant crops were first approved some years ago, and their use was so broadly and readily adopted that issues have arisen with regard to potential resistance to some weed species.  EPA is currently expected to approve another GE strain, Dicamba-tolerant crops, to control glyphosate tolerant weeds.

To critics of GE crops, using more herbicides to control problems caused by what they claim is overuse of another herbicide is evidence of a troubling “pesticide treadmill,” which they believe should not have been allowed to occur in the first place.  Rebutting this criticism, others assert that resistance is a problem for all pesticides, not only genetically modified ones, and that with sufficient controls, resistance can be delayed, if not avoided.  Registrants point out that it is very much in their self-interest to take steps to avoid resistance to their products -- once that occurs, the market viability of the product is significantly reduced.

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