By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 8, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of an existing stocks order under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1) governing further sale, distribution, and use of existing stocks of three reduced volatility dicamba products (XtendiMax®, EngeniaTM, and FeXapanTM) with conditional registrations that were vacated by the June 3, 2020, decision of the Ninth Circuit Court of Appeals in National Family Farm Coalition v. EPA. EPA explained its action by stating that the existing stocks order would provide “clarity to farmers” in light of the Court decision. Because EPA believes that vacatur made those stocks of the three dicamba products that were already in channels of trade unregistered pesticides, and the Court’s decision did not specifically address or establish any regimen to govern these unregistered existing stocks, EPA concluded that issuance of an existing stocks order was a practical necessity. The existing stocks order includes provisions that: (1) prohibit all sale and distribution of existing stocks of the three vacated dicamba products by the registrants, and by persons other than commercial applicators except for disposal of the products or returning the products to the registrants or their contract agents, (2) allow commercial applicators to use existing stocks of the vacated dicamba products in their possession in a manner consistent with existing labeling until July 31, 2020, and (3) prohibit end users from using existing stocks of the vacated dicamba products in their possession except in a manner consistent with existing labeling and from using such stocks in any manner after July 31, 2020.
Need for an Existing Stocks Order
To understand EPA’s position concerning the need for an existing stocks order for the three dicamba products with registrations vacated by the Ninth Circuit decision, it is important to review the legal status of those existing stocks after issuance of the decision. In the absence of further EPA action, all stocks of the three dicamba products subject to the vacatur order that were already in channels of trade became unregistered pesticides. Under FIFRA, as unregistered pesticides, these products could not be distributed or sold, which would prohibit stock of the unregistered products from being returned to the registrants or disposed, absent further EPA action. Stocks of the three products that were labeled for uses other than soybeans and cotton (the uses extended by the conditional registration decision vacated by the Court) also became unregistered and thus also could not be distributed or sold absent further action by EPA. Without further action by EPA, stocks of the three products already in the hands of end users could be lawfully used without any kind of restriction because although FIFRA Section 3(a) prohibits sale or distribution of unregistered pesticides, FIFRA does not include any provision prohibiting or limiting use of unregistered pesticides. Thus, the Court’s vacatur action created a situation in which EPA needed to act expeditiously to establish a rational regimen governing existing stocks of the three dicamba products. EPA was able to issue an order creating such a regimen because EPA construes the vacatur of the product registrations by Court action as a type of cancellation, which is how EPA has construed vacatur orders in the past. FIFRA Section 6(a)(1) expressly authorizes EPA to issue orders governing sale, distribution, and use of canceled pesticides.
EPA Policy for Existing Stocks Orders
EPA adopted a policy in 1991 (56 Fed. Reg. 29362) outlining six factors it generally considers in adopting existing stocks orders for canceled pesticides under FIFRA Section 6(a)(1): (1) the quantity of existing stocks at each level in channels of trade, (2) the risks resulting from use of existing stocks, (3) the benefits resulting from use of existing stocks, (4) financial expenditures users and others have already spent on existing stocks, (5) the risks and costs of disposal or alternative disposition of existing stocks, and (6) the practicality of implementing restrictions on the distribution, sale, or use of existing stocks. EPA applied this policy to the current situation and determined that “[e]ach of the six factors weighs heavily in support of allowing end users to use existing stocks of these dicamba products that are in their possession.” Since use of these unregistered pesticides is not otherwise prohibited by FIFRA as discussed above, EPA adopted prohibitions of use of the products not in accordance with the current labeling and of any use after July 31, 2020. The only action taken by EPA to authorize further use of the three products involved stocks held by commercial applicators, which EPA allowed the commercial applicators to use according to the current labeling until July 31, 2020.
EPA Administrator Wheeler stated, “At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply. Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty and to prevent the misuse of existing stocks.”
Three days after EPA issued the dicamba existing stocks order, on June 11, 2020, the Petitioners in the National Family Farm Coalition case submitted a motion requesting that the Court provide emergency relief “to enforce its vacatur” decision and that the Court hold EPA and Administrator Wheeler in contempt. According to the Petitioners, EPA’s entire rationale for issuing an existing stocks order is based on false premises. In the Petitioners’ view, existing stocks of the three dicamba products are not “unregistered” because the vacatur order only invalidated certain newly authorized uses, and the existing stocks should not be deemed to be “cancelled” either, although the conditional registration decision for the products has been vacated. In their motion, the Petitioners also assert that EPA is wrong because, “When read in context, FIFRA clearly prohibits the use of unregistered pesticides.” In addition to their request that the Court take emergency action to enforce its decision and hold EPA in contempt, the Petitioners also requested that the Court adjudicate their Endangered Species Act (ESA) claims, an action that would require that the Court recall the mandate and issue another decision on the ESA claims it previously declined to reach.
On June 12, 2020, the Court issued an order requiring EPA to file its response to the motion by 5:00 p.m. PDT on June 16, 2020, and the Petitioners to file any reply by 5:00 p.m. PDT on June 18, 2020.
In another development, BASF Corporation and E.I. DuPont de Nemours each filed separate “emergency motions” to intervene in the case on June 12, 2020. Each company asserts that it was not afforded notice that the Court might take adverse action concerning the registration for its dicamba product until after the decision vacating that registration was issued by the Court. At this juncture, the Court has not yet indicated whether it will consider these emergency intervention motions or whether it would be willing to allow any further briefing on the merits of the case.
Additional information on the Ninth Circuit Court of Appeals decision is available on our blog.
The Court’s June 3, 2020, decision stated, “We are aware of the practical effects of our decision,” but it is not clear from the discussion that follows whether the Court fully considered the chaotic effects of issuing a vacatur decision that did not specifically address the fate of existing stocks of the dicamba products with vacated registrations. On May 21, 2020, EPA asked for leave to file information on its plans to issue a cancellation order governing existing stocks of products with vacated registrations, but the Court declined to allow that filing. In any case, it should not have been surprising that EPA would construe its vacatur order as a form of cancellation, because that is what EPA did when the Ninth Circuit previously issued a vacatur order for sulfoxaflor products in 2015.
The Petitioners’ motion rejecting the basic legal premises underlying the EPA existing stocks order reflects a novel view of pesticide registration that is difficult to reconcile with the plain language and established constructions of FIFRA. Under FIFRA, EPA issues registrations for specific pesticide products, which may be labeled only for those uses that EPA has previously determined meet applicable requirements. Under FIFRA Section 6(b), EPA can decide that particular uses no longer meet the standard for registration and must be removed from an existing product label, but the only means by which EPA can effectuate that determination is by taking action to cancel any product for which the registrant does not agree to make the necessary changes. The Court vacated EPA’s conditional registration decision that authorized three registered dicamba products to be labeled for use on dicamba-tolerant soybeans and cotton but did not direct or establish any process for EPA to consider amending the product labeling or restoring the prior registrations. Under these facts, EPA has concluded that under FIFRA, existing stocks that are labeled for those uses became unregistered pesticide products because the labeling no longer conforms to the product registrations as they have been altered by the Court. In the absence of an existing stocks order, stocks of the affected products labeled for the disallowed uses could not be lawfully distributed for any purpose, including voluntary recall by the registrant, disposal, or relabeling to remove the disallowed uses.
Despite the assertions by the Petitioners that FIFRA prohibits use of unregistered pesticides, FIFRA has not been construed in this manner. While it a violation of FIFRA to distribute or sell any pesticide product with labeling that does not conform to a valid registration, FIFRA does not include any similar prohibition on use of an unregistered pesticide. Thus, in the absence of an existing stocks order, stocks of the three dicamba products with vacated registrations that are already in the hands of end users could be lawfully used without restriction. This notion is reflected in the provisions addressing end users in the order. No provision in the order authorizes end users who have the three dicamba products in their possession to do anything. Rather, the order prohibits end users from using the three products except in compliance with the existing labeling and from using the products at all after July 31, 2020.
Of course, it is not surprising that EPA applied its established criteria for existing stocks orders in the manner that it did. Representatives of affected growers argued that prohibiting all use of the products in the middle of the 2020 growing season would lead to billions of dollars in damages, at a time when the entire agricultural economy has already been severely impacted by the Covid-19 pandemic.
In addition to arguing that an existing stocks order was necessary to establish a practical regimen governing distribution and use of those stocks of the three dicamba products in channels of trade when the Court’s decision was issued, EPA will likely argue that the Circuit Court lacks jurisdiction to review the existing stocks order.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 3, 2020, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in National Family Farm Coalition v. EPA, No. 19-70115, vacating the U.S. Environmental Protection Agency’s (EPA) 2018 decisions to extend the conditional registrations for three reduced volatility dicamba herbicides, Bayer’s XtendiMax, Corteva’s FeXapan, and BASF’s Engenia.
The manufacturers of these dicamba products designed them to facilitate control of glyphosate resistant weeds in strains of soybeans and cotton that have been genetically modified to be dicamba tolerant (DT). Although the manufacturers intended these dicamba products to be less volatile and less susceptible to drift into adjacent non-target areas than previous formulations of dicamba, there were nonetheless many complaints that the products cause damage to non-tolerant crops and other vulnerable vegetation. The Petitioners that challenged EPA’s decision to extend the conditional registrations for these reformulated dicamba products include a group representing small farmers who claim that the new dicamba products have damaged their crops (National Family Farm Coalition) and several non-governmental organizations that routinely oppose new pesticide registrations (the Center for Food Safety, the Center for Biological Diversity, and Pesticide Action Network North America).
Although the case included some allegations by the Petitioners that EPA did not comply with the requirements of the Endangered Species Act, the court did not reach those issues. The court found unanimously that EPA’s decision to extend the conditional registrations for the three dicamba herbicides did not satisfy the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Specifically, the court found that the administrative record compiled by EPA did not include “substantial evidence” supporting EPA’s determination that registering the new uses “would not significantly increase the risk of any unreasonable adverse effects on the environment.” EPA is required under FIFRA Section 3(c)(7)(B) to make this determination to grant a conditional registration of new uses of a currently registered pesticide. The court concluded that EPA could not make this required determination because, the court stated, the record shows that EPA “substantially understated the risks that it acknowledged” and also “entirely failed to acknowledge other risks.”
According to the court, EPA made six material errors in its analysis supporting the registrations. First, the court stated that EPA understated the amount of acreage planted with DT crops in 2018, and consequently also underestimated the amount of the new dicamba products that would be applied that year, even though the decision to extend the conditional registrations for the new dicamba products was not issued until the end of the 2018 growing season. Second, in the court’s view, EPA improperly found that the number of complaints concerning damage to non-target crops and vegetation by the new dicamba products might be over-reported when the record included overwhelming evidence that non-target damage was being under-reported. Third, the court stated that EPA refused even to estimate how much damage to non-target vegetation would be caused by the new dicamba products when the record contained sufficient information for EPA to make such an estimate. Fourth, according to the court, EPA refused to acknowledge the substantial risk of non-compliance with the large number of detailed restrictions set forth in the 40-page approved label, although the court found that “there was substantial evidence that even conscientious applicators had not been able to consistently adhere to the label requirements.” Fifth, the court believes EPA failed to acknowledge the anti-competitive effect of the new technology, which encourages other growers to use DT crops even if they do not use the new dicamba products, to avoid damage from nearby applications. Sixth, according to the court, EPA failed to acknowledge the social cost being caused in small communities where damage caused by use of the new dicamba products has turned formerly amicable neighbors against each other.
Based on all of these purported deficiencies, the court held that EPA’s rationale for determining that the risk of unreasonable adverse effects would not be significantly increased by the new dicamba uses, and that the registration for the new dicamba products could therefore be extended for two additional years, was not supported by “substantial evidence” in the administrative record taken as a whole. The court also held that remanding the matter to EPA for further action without vacatur would not be appropriate because EPA did not satisfy the requirement to extend the conditional registrations. Instead, the court simply vacated the registrations and invited EPA to try again. The court acknowledged that such a decision would cause disruption, especially for those growers that have already purchased DT seeds and dicamba herbicides for this year's growing season, but concluded that no remedy other than vacatur would be appropriate given the deficiencies in the administrative record.
When FIFRA was amended to allow new pesticide products to be “conditionally” registered even though the applicants had not submitted data to satisfy all applicable requirements, the focus was primarily on allowing registration of new products that are “substantially similar” to already registered products. FIFRA Section 3(c)(7) also allows conditional registrations to be issued for new uses of existing active ingredients and for new active ingredients without all required data if EPA has sufficient information to make certain findings while it waits for additional data, but requires that EPA be able to determine that certain requirements can be met even though not all of the supporting data that will ultimately be needed are yet available.
This court’s decision illustrates the type of problems that can occur when EPA issues a conditional registration for new products that are not “substantially similar” to registered products. The court’s view of the sufficiency of the record in this case sets a high bar for the determinations that must support other types of conditional registrations. This problem was previously illustrated when a reviewing court vacated a new registration for a new nanosilver product even though there were already registered nanosilver products. In that case, because EPA chose as a matter of policy to characterize the product as a new active ingredient, it was required to make a “public interest” determination under FIFRA Section 3(c)(7)(C). When the administrative record was deemed insufficient to support this mandatory determination, the reviewing court vacated the registration.
In the case of the new dicamba products, to grant conditional registrations for new uses of an existing active ingredient, EPA was required to determine that the new uses on DT soybeans and cotton would not “significantly increase the risk of unreasonable adverse effects on the environment” under FIFRA Section 3(c)(7)(B). The court found the record supporting this mandatory determination to be insufficient, resulting in the court’s vacatur of EPA’s decision. These two reviewing courts have taken a relatively deep dive into the administrative record supporting a conditional registration for a new use of an existing active ingredient or a new active ingredient in evaluating whether substantial evidence in the record supports the determinations required by FIFRA. Whether future decisions will maintain such a stringent evidentiary standard will be important to monitor.
By Lisa M. Campbell, James V. Aidala, and Timothy D. Backstrom
On October 31, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it. EPA states that the label changes described below were made to ensure that these products can continue to be used effectively while addressing potential concerns to surrounding crops and plants. EPA’s dicamba registration decisions for the 2019-2020 growing season are:
- Two-year registration (until December 20, 2020);
- Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications);
- Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting;
- For cotton, limit the number of over-the-top applications from four to two (soybeans remain at two over-the-top applications);
- Applications will be allowed only from one hour after sunrise to two hours before sunset;
- The downwind buffer for all applications will remain at 110 feet, but in those counties where endangered species may exist, there will also be a new 57-foot buffer around the other sides of the field;
- Clarify training period for 2019 and beyond, ensuring consistency across all three products;
- Enhanced tank clean out instructions for the entire system;
- Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba; and
- Label clean up and consistency to improve compliance and enforceability.
EPA states that it has reviewed substantial amounts of new information and has determined that the continued registration of these dicamba products with the specified use restrictions meets the Federal Insecticide, Fungicide, and Rodenticide Act’s (FIFRA) registration standards. EPA also determined that extending these registrations with the new safety measures will not affect endangered species. More information on this extension is available on EPA’s website; more information on other dicamba issues is available on our blog.
As expected, this decision allows the continued use of the newer dicamba formulations intended to be applied on dicamba-resistant crop varieties. Of particular note is that EPA has not granted a permanent Section 3 registration, instead granting a time-limited, two-year registration which EPA states will expire at the end of 2020. This will allow EPA more time to assess in more detail whether the new use restrictions will further reduce problems of misuse, label complexity, or unexpected drift which have been reported in past growing seasons.
The most vexing issue behind plant injury reports over the past few years is whether these reports are mostly due to misuse (e.g., applicators who do not use the new formulations designed to reduce volatility, which is a label violation since the “old dicamba” product is considered more prone to cause drift injury), or, are due to characteristics of the new formulations which are not yet fully understood and which lead to unexpected volatility and other drift problems. Some have also argued that problems are also due to the difficulty (or reluctance) in following the more prescriptive requirements for the new formulations. The two-year renewal will continue to see EPA closely monitor injury and misuse reports, as well as continued academic and registrant research into the likely cause of any reported problems.
EPA’s decision also imposes further requirements for additional training, timing, record-keeping, and stewardship when using the new dicamba formulations that are designed to reduce or to eliminate those plant injury reports that are not clearly attributable to misuse of the older dicamba products. EPA will rely on state officials to report and evaluate the experience of users in their respective states, especially concerning whether the additional training and stewardship requirements significantly reduce local injury reports.
By Lisa M. Campbell and James V. Aidala
On January 3, 2018, officials with the Arkansas State Plant Board (Plant Board) voted 11 to 3 to uphold its statewide ban of dicamba. The vote came after a subcommittee of the state's legislative council asked the board to reevaluate its earlier decision. The subcommittee will revisit the Plant Board's decision again on January 16, 2018. That the subcommittee plans to revisit its decision in just two weeks is noteworthy and illustrates the controversy surrounding this and other similar state bans.
Given the panel will meet again in the next few weeks, this may indicate that the legislature is urging some greater flexibility -- that is, a longer application window that would allow some growers to use the herbicide, along with consideration of any data about the newer formulations designed to reduce the likelihood of drift.
Whether any “flexibility” or additional data will be sufficient to convince the Plant Board that the product can be used without expecting drift incidents in the future is not clear, especially since the issue has become a point of intense political debate.
More information on dicamba issues is available on our blog under key word dicamba.
By James V. Aidala, Lisa M. Campbell, and Timothy D. Backstrom
On December 14, 2017, the Missouri Department of Agriculture (MDA) announced that it issued and collected the first round of fines resulting from investigations regarding the pesticide dicamba. The news release states that the first wave of civil penalties issued to applicators, all from Dunklin County, were issued as “a result of investigations of complaints during the 2016 growing season,” and the “civil penalties, ranging from $1,500 to $62,250, were issued for pesticide misuse (off label use and drift).” Further, in 2016, “Department staff conducted and completed 121 complainant investigations. Those complainants named approximately 60 applicators, who were investigated as a result of complaints. In addition, the Department investigated nearly 100 non-Dicamba related incidents.”
This is the first group of what is anticipated to be a large number of dicamba-related enforcement cases, given the extensive number of, and publicity concerning, the reported incidents involving dicamba. Reported incidents in Arkansas were even more numerous than those in Missouri. About one-third of the reported incidents in Missouri have now been attributed to only six applicators. One applicator alone was cited for 149 discrete violations, which indicates that problems with the new dicamba formulations may be less widespread than some originally feared based on the large number of reported incidents. Moreover, some of the states where the new dicamba products were widely used have reported very few incidents. In the aggregate, this data suggests that better stewardship training accompanied by rigorous enforcement may be sufficient to greatly reduce the future incidence of unexpected off-site movement of the new dicamba formulations.
More information on dicamba issues is available in our blog.
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.
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.