We’ve quickly reached the end of January, and several of the legal issues I’ve talked about in OSU’s “Agricultural Outlook” meetings have surfaced this month. If the current pace keeps up, 2022 promises to be a busy year for agricultural law. Here’s a review of three legal issues I predict we’ll see that have already begun to emerge in 2022.
Water, water. From defining WOTUS to addressing Lake Erie water quality, water law will continue to be everywhere this year. The U.S. Supreme Court just announced on January 24 that it will hear the well-known case of Sackett v EPA to review whether the Ninth Circuit Court of Appeals used the proper test to determine whether wetlands are “waters of the United States” (WOTUS). The case is one example of the ongoing push-pull in the WOTUS definition, which establishes waters that are subject to the federal Clean Water Act. The Biden administration proposed a new WOTUS rule last December that would replace the Trump-era rule, and comments remain open on that definition until February 7. Ohio has wrangled with its own water issues, particularly with agricultural nutrient impacts on water quality. We’ll see this year if the state will continue to rely on H2Ohio and similar incentive-based programs and whether the Ohio EPA will face additional litigation over its development of a Total Maximum Daily Load for Lake Erie.
Pesticide challenges. The EPA announced a new policy on January 11 to more closely evaluate potential effects of pesticide active ingredients on endangered species and critical habitats. That was the same day the agency re-registered Enlist One and Enlist Duo pesticides, but with new label restrictions and prohibited use in hundreds of counties across the U.S., including a dozen Ohio counties. An EPA report documenting dicamba damage in 2021 could form the basis for yet another lawsuit this year demanding that EPA vacate dicamba’s registration. Meanwhile, we await a decision by the U.S. Supreme Court on whether it will review Hardeman v. Monsanto, one of dozens of cases awarding damages against Monsanto (now Bayer) for personal injury harms caused by glyphosate.
Opposition to livestock production practices. Ohio pork producers watching California’s Proposition 12 will be happy with a recent California court decision prohibiting enforcement of one part of the law that went into effect on January 1. The provision requires any pork and eggs sold in the state to be from breeding pigs and laying hens that are not raised in a “cruel manner,” meaning that the animals have a certain amount of usable pen space. The California court agreed with grocers and other retailers that the law could not be enforced on sales of pork meat because the state hasn’t yet finalized its regulations. The law could be subject to further scrutiny from a higher court. Several agricultural organizations have unsuccessfully challenged the law as a violation of the Constitution’s Commerce Clause, but one of those cases currently awaits a decision from the U.S. Supreme Court on whether it will review the case. Other livestock production issues we’ll see this year include continued battles over Right to Farm laws that limit nuisance lawsuits against farms, and challenges to “ag gag” laws that aim to prevent or punish undercover investigations on farms.
There’s more to come. Watch for more of our predictions on what 2022 may bring to the agricultural law arena in upcoming posts. Or drop into one of our Agricultural Outlook and Policy meetings to hear my Ag Law Outlook. As quickly as the year is moving, we’ll soon know how many of those predictions are correct.
Spring is a common time for farmers to deal with pesticides and insecticides, but this spring the legal system has also been busy with pesticides and insecticides. Important legal developments with dicamba, glyphosate, and chlorpyrifos raise questions about the future of the products, with proponents on both sides pushing for and against their continued use. In today’s post, we summarize legal activity concerning dicamba. Part 2 to this series will cover recent developments with Roundup.
Dicamba registration lawsuits. In April, the federal courts resumed two cases filed late last year that challenge the registration and label of dicamba products made by Bayer, BSF and Syngenta. The cases had been on hold since February due to the change to the Biden Administration and its EPA leadership. Center for Biological Diversity v. EPA, in federal district court in Arizona, claims that the 2020 registration of the products should not have been granted because the registration fails to meet the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) standard that a pesticide may not cause “unreasonable adverse effects” to the environment. Relief requested by the plaintiffs includes overturning the registration approvals and also ordering EPA to officially reverse via rulemaking its long-standing policy to allow states to impose local restrictions on pesticide registrations under FIFRA’s Section 24(C).
In the D.C. district court, American Soybean Association v EPA takes the opposite approach and argues that the EPA exceeded its duties under FIFRA by imposing application cutoff dates of June 30 for soybeans and July 30 for cotton and establishing 310-foot and 240-foot buffer zones for certain endangered species. The plaintiffs in that suit want the court to remove the cutoff dates and buffer restrictions from the approved dicamba labels. Manufacturers Bayer, BASF, and Syngenta have intervened in the cases, which both now await responses from the EPA.
Two additional challenges to the dicamba 2020 label approval were consolidated for review to be heard together by the D.C. Circuit Court of Appeals and now await the court’s decision. National Family Farm Coalition v. EPA originally filed in the Ninth Circuit Court of Appeals, argues that EPA failed to support its conclusion of “no unreasonable adverse effects” and did not ensure that endangered species and critical habitat would not be jeopardized by approved dicamba use. On the flip side, American Soybean Association v. EPA alleges that the 2020 label cutoff dates are too restrictive and buffer requirements are too large, which exceeds the authority granted EPA in FIFRA and the Endangered Species Act. The EPA has filed a motion to dismiss the cases but the plaintiffs have asked to be returned to the Ninth Circuit.
Bader Farms Appeal. The$265 jury verdict awarded last year to Bader Farms, which successfully argued that Monsanto was responsible for harm to its peach farms resulting from dicamba drift, is on appeal before the Eighth Circuit Court of Appeals. Monsanto filed its brief on appeal in March, arguing that the verdict should be reversed for several reasons: because the court had not required Bader Farms to prove that Monsanto had manufactured or sold the herbicides responsible for the damages, which could have resulted from third party illegal uses of herbicides; because the damages were based on “speculative lost profits”; and because the $250 million award of punitive damages violated state law in Missouri.
Office of Inspector General Report. The EPA’s Office of the Inspector General (OIG), also played a role in recent dicamba developments. The OIG is an independent office within the EPA that audits, investigates and evaluates the EPA. Just last week, the OIG issued a report on EPA’s decision in 2018 to conditionally register dicamba products, allowing them to be used during the 2019 and 2020 growing seasons. That decision by EPA ultimately led to a legal challenge by environmental groups, a holding by the Ninth Circuit Court of Appeals that the EPA violated FIFRA in approving the registrations, and a controversial order ceasing use of the dicamba products. The OIG evaluated the EPA’s registration decision making process for the dicamba registration. The title to its report, “EPA Deviated from Typical Procedures in Its 2018 Dicamba Pesticide Registration Decision” is telling of the OIG’s conclusions.
OIG determined that EPA had “varied from typical operating procedures” in several ways. The EPA did not conduct the required internal peer reviews of scientific documents created to support the dicamba decision. Senior leaders in the EPA’s Office of Chemical Safety and Pollution Prevention were “more involved” in the dicamba decision than in other pesticide registration decisions, resulting in senior-level changes to or omissions from scientific analyses to support policy decisions. EPA staff were “constrained or muted in sharing their scientific integrity concerns” on the dicamba registrations. The result of these atypical operating procedures by the EPA, according to the OIG, was substantial understatement or lack of acknowledgement of dicamba risks and the eventual decision by the Ninth Circuit to vacate the registrations.
The OIG recommended three actions the EPA should take in response to the report: requiring senior managers or policy makers to document changes or alterations to scientific opinions, analyses, and conclusions in interim and final pesticide registration decisions along with their basis for changes or alterations; requiring an assistant administrator-level verification statement that Scientific Integrity Policy requirements were reviewed and adhered to during pesticide registration decisions; and conducting annual training for staff and senior managers and policy makers to promote a culture of scientific integrity and affirm commitment to the Scientific Integrity Policy. The EPA had already taken action on the OIG’s first and third recommendations but has not resolved the second.
Will the OIG Report affect ongoing litigation on dicamba, or lead to additional lawsuits? That’s a critical question without an immediate answer, and one to keep an eye on beyond this spring.
To read more about legal issues with dicamba, visit our partner, The National Agricultural Law Center and its excellent series on "The Deal with Dicamba."
Dicamba, Roundup, WOTUS, and ag-gag: although there are important updates, this week’s Harvest topics could be considered some of the Ag Law Blog’s “greatest hits.” In addition to these ongoing issues, a bill that is meant to encourage farmers to participate in carbon markets was recently introduced in the Senate. June has certainly been a busy month.
Decisions on dicamba. If you’ve been following along with our blog posts over the past few weeks, you know that the Ninth Circuit Court of Appeals vacated the registration of several over-the-top dicamba products, and in response, the EPA announced that all such products in farmers’ possession must be used before July 31, 2020 (our last post on the topic is available here). The Ohio Department of Agriculture went a step further, making the final date for dicamba use in the state June 30, 2020, due to the state registrations expiring on that day. Since the Ninth Circuit decision, the companies that produce dicamba products such as Engenia and, FXapan, and XtendiMax have filed numerous motions with the Ninth Circuit. On June 25, the court declined a motion from the BASF Corporation, which makes Engenia, asking the court to pause and withdraw their decision from the beginning of the month. What does this mean? Basically, at this moment, the court’s ruling still stands, and use of certain over-the-top products will have to cease on the dates mentioned above. That’s the latest on this “volatile” issue.
Bayer settles Roundup lawsuits, but this probably isn’t the end. Bayer, the German company that purchased Monsanto and now owns rights to many of the former company’s famous products, has been fighting lawsuits on multiple fronts. Not only is the company involved in the dicamba battle mentioned above, but over the past few years it has had a slew of lawsuits concerning Roundup. On June 24, Bayer, the German company that now owns the rights to Roundup, announced that it would settle around 9,500 lawsuits. The lawsuits were from people who claimed that Roundup’s main ingredient, glyphosate, had caused health problems including non-Hodgkin’s lymphoma. The amount of the settlement will be between 8.8 and 9.6 billion dollars. Some of that money will be saved for future Roundup claims. Although many are involved in this settlement, there are still thousands of claims against Bayer for litigants who did not want to join the settlement.
Updated WOTUS still not perfect. As always, there is an update on the continuing saga of the waters of the United States (WOTUS) rule. If you recall, back in April, the Trump administration’s “final” WOTUS rule was published. Next, of course, came challenges of the rule from both sides, as we discussed in a previous Harvest post. Well, the rule officially took effect (in most places, we’ll get to that) June 22, despite the efforts of a group of attorneys general from Democratically-controlled states attempting to halt the implementation of the rule. The attorneys general asked the U.S. District Court for the Northern District of California a nationwide preliminary injunction, or pause on implementation of the rule until it could be sorted out in the courts. The district court judge denied that injunction on June 19. On the very same day, a federal judge in Colorado granted the state’s request to pause the implementation of the rule within the state’s territory. Remember that the 2015 rule was implemented in some states and not others for similar reasons. The same trend seemingly continues with Trump’s replacement rule. In fact, numerous lawsuits challenging the rule are ongoing across the country. A number of the suits argue that rule does not go far enough to protect waters. For instance, just this week environmental groups asked for an injunction against the rule in the U.S. District Court for the District of Columbia. Environmental organizations have also challenged the rule in Maryland, Massachusetts, and South Carolina district courts. On the other hand, agricultural groups like the New Mexico Cattle Growers Association have filed lawsuits arguing that the rule is too strict.
No more ag-gag in NC? We have mentioned a few times before on the blog that North Carolina’s ag-gag law has been embroiled in a lawsuit for several years (posts are available here). North Carolina’s version of “ag-gag” was somewhat different from other states, because the statute applied to other property owners, not just those involved in agriculture. The basic gist of the law was that an unauthorized person entering into the nonpublic area of a business was liable to the owner or operator if any damages occurred. This included entering recording or surveilling conditions in the nonpublic area, which is a tool the plaintiffs use to further their cause. In a ruling, the U.S. District Court for the Middle District of North Carolina was decided largely in the plaintiffs’ (PETA, Animal Legal Defense Fund, etc.) favor. In order to not get into the nitty gritty details of the 73-page ruling, suffice it to say that the judge found that that law did violate the plaintiffs’ freedom of speech rights under the First Amendment to the U.S. Constitution. Another ag-gag law bites the dust.
Carbon markets for farmers? And, now for something completely different. In the beginning of June, a bipartisan group of four U.S. senators introduced the “Growing Climate Solutions Act.” On June 24, the Senate Committee on Agriculture, Nutrition, and Forestry held its first hearing on the new bill, numbered 3894. The text of SB 3894 is not currently available online, but it would create “a certification program at USDA to help solve technical entry barriers that prevent farmer and forest landowner participation in carbon credit markets.” The barriers “include access to reliable information about markets and access to qualified technical assistance providers and credit protocol verifiers” and “have limited both landowner participation and the adoption of practices that help reduce the costs of developing carbon credits.” You can read the Committee’s full press release about the bill here. It is backed by several notable businesses and groups, including the American Farm Bureau Federation, the National Corn Growers Association, the Environmental Defense Fund, and McDonalds and Microsoft.
There was a great deal of action last Friday in the case that vacated the registrations of XtendiMax, Engenia and FeXapan dicamba-based products. Despite a barrage of court filings on Friday, however, nothing has changed the current legal status of the dicamba products in Ohio, and Ohio growers may use existing stocks of the products now but must end use by June 30, 2020.
Here’s a rundown of the orders that the Ninth Circuit Court of Appeals issued in the case last Friday:
- The court denied the emergency motion that the petitioners (National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity, and Pesticide Action Network North America) filed on June 13. That motion asked the court to enforce its previous mandate to vacate the registrations, to prevent any further use of the products, and to hold the EPA in contempt for issuing the Cancellation Order the agency had made that allowed continued use of existing stocks of the products. The court did not provide its reasoning for denying the motion.
- The court granted amicus curiae (friend of the court) status to CropLife America and American Farm Bureau (representing itself as well as national soybean, cotton, wheat, corn and sorghum association interest.) Those parties filed their amicus curiae briefs in support of the EPA’s Cancellation Order and in opposition to the petitioners' emergency motion.
- The court granted also emergency motions to intervene in the case filed by BASF Corporation, maker of Engenia, and DuPont (Corteva) , maker of FeXapan. The companies argued that they did not know that the scope of the court’s order on Bayer's XtendiMax product registration would also affect their dicamba product registrations and they should now be permitted an opportunity to defend their products.
- BASF filed a motion asking the court to recall the court's mandate that had cancelled the registrations of the products, claiming that the court had not followed appropriate procedural rules. In its brief, BASF also suggested that the company would be filing petitions for rehearing since BASF had not had an opportunity to be heard when the court vacated the registration of its Engenia product.
- The court ordered the original petitioners to file a brief in response to BASF’s motion to recall the mandate by June 23, and for BASF to reply to that brief by June 24.
The companies that make the dicamba products clearly intend to challenge the vacatur of their product registrations, even though the EPA's Cancellation Order allows continued use of existing stocks of the products until July 30, 2020. This dicamba battle is not yet over, and we'll keep you posted on new developments.
Read our previous posts on the court's vacatur in National Family Farm Coalition here, on the EPA's Cancellation Order here, and on the Ohio Department of Agriculture's ruling on use of the products in Ohio here.
The dicamba roller coaster ride continues today, with a statement issued by the Ohio Department of Agriculture clarifying that the use of XtendiMax, Engenia, and FeXapan dicamba-based products in Ohio will end as of June 30, 2020. Even though the US EPA has issued an order allowing continued use of the products until July 31, 2020, use in Ohio must end on June 30 because the Ohio registrations for the three dicamba-based products expire on that day.
As we’ve explained in our previous blog posts here and here, the Ninth Circuit Court of Appeals vacated the registration of the dicamba products on June 3, 2020. In doing so, the court stated that the EPA had failed to perform a proper analysis of the risks and resulting costs of the products. According to the court, EPA had substantially understated the amount of acreage damaged by dicamba and the extent of such damage, as well as complaints made to state agriculture departments. The court determined that EPA had also entirely failed to acknowledge other risks, such as the risk of noncompliance with complex label restrictions, economic risks from anti-competition impacts created by the products, and the social costs to farm communities caused by dicamba versus non-dicamba users. Rather than allowing the EPA to reconsider the registrations, the court vacated the product registrations altogether.
The EPA issued a Cancellation Order for the three products on June 8, stating that distribution or sale by the registrants is prohibited as of June 3, 2020. But the agency also decided to examine the issue on the minds of many farmers: what to do with the products. Applying its “existing stocks” policy, the EPA examined six factors to help it determine how to deal with stocks of the product that are in the hands of dealers, commercial applicators, and farmers. The EPA concluded that those factors weighed heavily in favor of allowing the end users to use the products in their possession, but that use must occur no later than July 31, 2020 and that any use inconsistent with the previous label restrictions is prohibited.
Despite the EPA’s Cancellation Order, however, the Ohio Department of Agriculture is the final arbiter of the registration and use of pesticides and herbicides within Ohio. ODA patiently waited for the EPA to act on the Ninth Circuit’s ruling before issuing its guidance for Ohio users of the dicamba products. In its guidance released today, ODA stated that:
- After careful evaluation of the court’s ruling, US EPA’s Final Cancellation Order, and the Ohio Revised Code and Administrative Code, as of July 1, 2020, these products will no longer be registered or available for use in Ohio unless otherwise ordered by the courts.
- While use of already purchased product is permitted in Ohio until June 30, further distribution or sale of the products is illegal, except for ensuring proper disposal or return to the registrant.
- Application of existing stocks inconsistent with the previously approved labeling accompanying the product is prohibited.
But the roller coaster ride doesn’t necessarily end there. Several dangling issues for dicamba-based product use remain:
- We’re still waiting to see whether the plaintiffs who challenged the registrations (the National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity, and Pesticide Action Network North America) will also challenge the EPA’s Cancellation Order and its decision to allow continued use of the products, and will request immediate discontinuance of such uses.
- Bayer Crop Science, as an intervenor in the Ninth Circuit case, could still appeal the Ninth Circuit’s decision, as could the EPA.
- All of these orders add complexity to the issue of liability for dicamba damage. That issue has already become quite controversial, often pitting farmer against farmer and requiring the applicator or damaged party to prove adherence to or violation of the complicated label restrictions. But the Ninth Circuit’s attention to the risks of adverse impacts from the products raises additional questions about whether an applicator who chooses to use the products is knowingly assuming a higher risk, and whether a liability insurance provider will cover that risk. For this reason, growers may want to have a frank discussion with their liability insurance providers about coverage for dicamba drift.
The dicamba roller coaster ride will surely continue, and we’ll keep you updated on the next development.
Read the ODA’s Official Statement Regarding the Use of Over-the-Top Dicamba Products here.
When we explained in our last blog post the recent Court of Appeals decision that vacated the registration of three dicamba-based products, we mentioned that one possibility for answering the “what happens now” question was for the EPA to issue a cancellation order that would allow end users to use existing stocks of the products. That’s exactly what happened yesterday, when the US EPA made a final order that cancels the registrations of XtendiMax, Engenia, and FeXapan but allows for movement and use of the products. Here’s a summary of the agency’s order.
Authority to issue the cancellation order
After reviewing the background of the dicamba product registrations vacated by the Ninth Circuit Court of Appeals last week for lack of “substantial evidence” supporting the registrations, the EPA stated that it was relying upon the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to establish provisions for the disposition of existing stocks of registrations that are found to be invalid. “The Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is suspended or canceled under [sections 3, 4 or 6 of FIFRA] to such extent, under such conditions, and for such uses as the Administrator determines that such sale or use is not inconsistent with the purposes of [FIFRA]” stated the agency.
The EPA noted that FIFRA does not prohibit the use of unregistered pesticides, but only prohibits the sale and distribution of unregistered pesticides. The agency noted that without its action, end users holding stocks of the products aren’t prevented from using the stocks without following the now voided label directions and restrictions. And the agency pointed to a similar action it took after a 2015 court order that vacated the registration of sulfoxaflor and a 2010 court decision that vacated the registration of spirotetramat. In both cases, the EPA utilized a cancellation order to establish terms and conditions for the disposition of existing stocks of the products.
Existing Stocks Determination
Back in 1991, the EPA established an “existing stocks policy” to help the agency assess how to treat existing stocks of cancelled pesticides, both when no significant risk concerns have been identified and when there are significant risk concerns for a cancelled product. The agency noted that it considered the six factors outlined in the policy for considering significant risk concerns associated with a cancelled pesticide and reached the conclusion that “distribution and use in certain narrow circumstances is supported.” The six factors the agency considered in determining what to do with the existing stocks of dicamba products are:
- Quantities of existing stocks at each level of the channels of trade
The agency noted that due to the current timing of the growing season, significant existing stocks are present in the possession of end users and throughout the channels of trade. Stating that it couldn’t determine the exact quantities of existing stocks at each level of the channels of trade, the EPA estimates that “approximately 4 million gallons could be in the channels of trade.”
- Risks resulting from the use of the existing stocks
Again concluding that because the product registrations were vacated and the labels therefore voided, end users were not legally bound to follow label restrictions if using the dicamba products. The agency concluded that such non-label uses would have greater potential for adverse effects than if the agency issued an order allowing and regulating the use of the existing stocks. Such an order is imperative, said the agency, to ensure that any use of the products would be consistent with previously approved labeling and could be enforced in order to prevent unreasonable adverse effects on the environment. Surprisingly, the EPA gave little attention to the volatility concerns raised by the Ninth Circuit in its decision last week, and evidence the court pointed to in that case that suggested that even applications by those who carefully followed the label restrictions were subject to drift and damage.
- The benefits resulting from the use of existing stocks
Capitalizing on the unfortunate timing of the Ninth Circuit’s vacation of the pesticide in regards to immediate needs for the current growing season, the agency concluded that “the benefits resulting from the use of the products are considerable and well established, particularly for this growing season.” The EPA reiterated many of the numerous communications it had received stating how essential the over-the-top products are, especially with the growing season underway. It also concluded that allowing non-over-the-top uses would result in substantially greater benefits to users and society than would disposal of the products.
- The financial expenditures users and others have already spent on existing stocks
Echoing the concerns of many farmers and again pointing to the current growing season, the agency concluded that “the costs to farmers are not limited to their existing stocks of these dicamba products, but include other sunk costs made in expectation of the availability of these products (seed purchase, tilling, planting, etc.) as well as the lost opportunity to switch to a different crop or to another herbicide or weed management method.”
- The risks and costs of disposal or alternative disposition of the stocks
The EPA concluded that disposal of the existing stocks of dicamba products would incur substantial costs for all and for stock already in the hands of end users, “may be neither feasible nor advisable.” Additionally, the agency pointed to disposal or return of opened containers which would have high risks of spillage and increased expenses for proper disposal.
- The practicality of implementing restrictions on distribution, sale, or use of the existing stocks
Another option available to the agency under FIFRA would be to issue individual stop sale, use and removal orders to all end users holding dicamba products, but the EPA concluded that such an action would be unwarranted under the present facts because tracking the existing stocks would be burdensome, inaccurate and impractical and that “hard-pressed farmers who have made large investments in their existing stocks may be uncooperative with a cancellation order that requires disposal.”
After weighing the six factors above, the EPA concluded that the six factors weigh heavily in support of allowing end users to use existing stocks of the dicamba products in their possession. However, the agency imposed a July 31 , 2020 cut-off date for use of existing stocks in order to “further reduce the potential for adverse effects.” Here are the final orders the agency made for distributed, sale and use of the products:
- Distribution or sale by the registrant. Distribution or sale by the registrant of all existing stocks of the products listed below is prohibited effective as of the time of the order on June 3, except for distribution for the purposes of proper disposal.
- Distribution or sale by persons other than the registrant. Distribution or sale of existing stocks of the products listed below that are already in the possession of persons other than the registrant is permitted only for the purposes of proper disposal or to facilitate return to the registrant or a registered establishment under contract with the registrant, unless otherwise allowed below.
- Distribution or sale by commercial applicators. For the purpose of facilitating use no later than July 31, 2020, distribution or sale of existing stocks of products listed below that are in the possession of commercial applicators is permitted.
- Use. Use of existing stocks of products inconsistent in any respect with the previously-approved labeling accompanying the product is prohibited. All use is prohibited after July 31, 2020.
While the manufacturers of XtendiMax, Engenia, and FeXapan are prohibited from selling and distributing their products effective as of June 3, 2020, the EPA’s cancellation order allows others to return, dispose of, or use the products according to the previous label restrictions and no later than July 31, 2020. But a few other factors come into play:
- Some states have already taken actions to restrict the use of the dicamba products within their states, which is within a state’s authority. Ohio has not done so, and instead has stated that it has been awaiting US EPA guidance on the legal status of the products and will communicate options for farmers afterwards. This means that users in Ohio should keep a close eye on the Ohio Department of Agriculture to see if it will go along with the US EPA’s guidance or direct otherwise.
- A cancellation order issued by the EPA is a final agency action that is subject to appeal, so we might see an immediate of the cancellation order and a request to stay the order pending appeal. Such an appeal could challenge whether the EPA has the authority to regulate existing stocks of the products and whether the agency’s analysis sufficiently addressed the risks of adverse impacts from continued use.
As seems often to be the case with dicamba, there’s a mixed sense of drama and dread with what lies ahead. We’ll be sure to keep you posted on the next legal news for dicamba.
Read the US EPA’s cancellation order for XtendiMax, Engenia, and FeXapan here.
Dicamba has had its share of legal challenges, and a decision issued yesterday dealt yet another blow when the Ninth Circuit Court of Appeals vacated the product’s registration with the U.S. EPA. In doing so, the court held that the EPA’s approval of the registration violated the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), which regulates the use of herbicides and other chemicals in the U.S. Here’s a summary of how the court reached its decision and a few thoughts on the uncertainty that follows the opinion.
The challenge: EPA’s approval of three dicamba products
We first have to step back to 2016, when the EPA approved three dicamba-based products-- Monsanto’s XTendiMax, DuPont’s FeXapan, and BASF’s Engenia--as conditional use pesticides for post-emergent applications in 34 states, including Ohio. Although dicamba has been around for years, the approval came after the companies reformulated dicamba to make it less volatile and in anticipation of the development of dicamba tolerant soybean and cotton seeds. The agency conducted a risk assessment and concluded that if used according to the label restrictions, the benefits of the dicamba products outweighed “any remaining minimal risks, if they exist at all.” The EPA also provided that the registrations would automatically expire if there was a determination of an unacceptable level or frequency of off-site dicamba damage.
Before the conditional registrations were set to automatically expire in late 2018, the EPA approved requests by Bayer CropScience (previously Monsanto), Cortevo (previously DuPont) and BASF to conditionally amend the registrations for an additional two years. The approval came despite widespread concerns about dicamba drift and damage during the 2017 growing season. To address those concerns, EPA chose not to conduct a new risk assessment and instead adopted additional label restrictions that had been proposed by Monsanto/Bayer to minimize off-field movement of dicamba. Many states added restrictions for dicamba use that exceeded the label restrictions, including banning any use of the product during certain periods.
Several organizations challenged the EPA’s dicamba registration approvals. The National Family Farm Coalition, Center for Food Safety, Center for Biological Diversity, and Pesticide Action Network North America filed suit against the EPA, claiming that the agency violated both FIFRA and the Endangered Species Act in approving the product registrations. Monsanto requested and was granted permission to intervene in the case.
The Ninth Circuit’s review
To approve the request to amend the dicamba registrations, FIFRA required the EPA to make two conclusions: first, that the applicant had submitted satisfactory data related to the proposed additional use of the pesticide and second, that the approval would not significantly increase the risk of unreasonable adverse effects on the environment. The task before the Ninth Circuit Court of Appeals was to review the EPA’s 2018 decision and determine whether there was substantial evidence to support the EPA's conclusions and amend the registrations.
The conclusion that drew the most attention from the court was the EPA’s determination that amending the dicamba registrations for two years would not cause unreasonable adverse effects on the environment. The court determined that the EPA erred in making this conclusion when it substantially understated several risks of dicamba registration, such as:
- Misjudging by as much as 25% the amount of acreage on which dicamba would be used in 2018.
- Concluding that complaints to state departments of agriculture could have either under-reported or over-reported the actual amount of dicamba damage, when the record clearly showed that complaints understated the amount of damage.
- Failing to quantify the amount of damage caused by dicamba, “or even to admit that there was any damage at all,” despite having information that would enable the EPA to do so.
But that’s not all. The court pointed out that the agency had also “entirely failed to acknowledge other risks, including those it was statutorily required to consider,” such as:
- The risk of substantial non-compliance with label restrictions, which the court noted became “increasingly restrictive and, correspondingly, more difficult to follow” and to which even conscientious applicators could not consistently adhere.
- The risk of economic costs. The court stated that the EPA did not take into account the “virtually certain” economic costs that would result from the anti-competitive effect of continued dicamba registration, citing evidence in the record that growers were compelled to adopt the dicamba products just to avoid the possibility of damage should they use non-dicamba tolerant seed.
- The social costs of dicamba technology to farming communities. The court pointed out that a farmer in Arkansas had been shot and killed over dicamba damage, that dicamba had “pitted neighbor against neighbor,” and that the EPA should have identified the severe strain on social relations in farming communities as a clear social cost of the continued registration of the products.
Given the EPA’s understatement of some risks and failure to recognize other risks, the Court of Appeals concluded that substantial evidence did not support the agency’s decision to grant the conditional registration of the dicamba products. The EPA “failed to perform a proper analysis of the risks and resulting costs of the uses,” determined the court. The court did not address the Endangered Species Act issue.
A critical point in the decision is the court’s determination of the appropriate remedy for the EPA’s unsupported approval of the dicamba products. The EPA and Monsanto had asked the court to utilize its ability to “remand without vacatur,” or to send the matter back to the agency for reconsideration. The remedy of “vacatur,” however, would vacate or void the product registrations. The court explained that determining whether vacatur is appropriate required the court to weigh several criteria, including:
- The seriousness of the agency’s errors against the disruptive consequences of an interim change that may itself be changed,
- The extent to which vacating or leaving the decision in place would risk environmental harm, and
- Whether the agency would likely be able to offer better reasoning on remand, or whether such fundamental flaws in the agency’s decision make it unlikely that the same rule would be adopted on remand.
The court’s weighing of these criteria led to its conclusion that vacating the registrations of the products was the appropriate remedy due to the “fundamental flaws in the EPA’s analysis.” Vacating the registrations was not an action taken lightly by the court, however. The judges acknowledged that the decision could have an adverse impact on growers who have already purchased dicamba products for the current growing season and that growers “have been placed in this situation through no fault of their own.” Clearly, the court places the blame for such consequences upon the EPA, reiterating the “absence of substantial evidence” for the agency’s decision to register the dicamba products.
The court raised the issue we’re all wondering about now: can growers still use the dicamba products they’ve purchased? Unfortunately, we don’t have an immediate answer to the question, because it depends largely upon how the EPA responds to the ruling. We do know that:
- FIFRA § 136a prohibits a person from distributing or selling any pesticide that is not registered.
- FIFRA § 136d allows the EPA to permit continued sale and use of existing stocks of a pesticide whose registration is suspended or canceled. The EPA utilized this authority in 2015 after the Ninth Circuit Court of Appeals vacated the EPA’s registration of sulfoxaflor after determining that the registration was not supported by substantial evidence. In that case, the EPA allowed continued use of the existing stocks of sulfoxaflor held by end-users provided that the users followed label restrictions. Whether the agency would find similarly in regards to existing stocks of dicamba is somewhat unlikely given the court's opinion, but remains to be seen. The EPA’s 2015 sulfoxaflor cancellation order is here.
- While the U.S. EPA registers pesticides for use and sale in the U.S., the product must also be registered within a state in order to be sold and used within the state. The Ohio Department of Agriculture oversees pesticide registrations within Ohio, and also regulates the use of registered pesticides.
- If the EPA appeals the Ninth Circuit’s decision to the U.S. Supreme Court, the agency would likely include a request for a “stay” that would delay enforcement of the court’s Order.
- Bayer strongly disagrees with the decision but has paused its sale, distribution and use of XtendiMax while assessing its next step and awaiting EPA direction. The company states that it will “work quickly to minimize any impact on our customers this season.” Bayer also notes that it is already working to obtain a new registration for XtendiMax for the 2021 season and beyond, and hopes to obtain the registration by this fall. See Bayer’s information here.
- BASF and Corteva have also stated that they are awaiting the EPA’s reaction to the decision, and will “use all legal remedies available to challenge this Order.”
- Syngenta has clarified that its Tavium Plus VaporGrip dicamba-based herbicide is not part of the ruling and .that the company will continue selling that product.
For now, all eyes are on the U.S. EPA’s reaction to the Ninth Circuit’s decision, and we also need to hear from the Ohio Department of Agriculture. Given the current state of uncertainty, it would be wise for growers to wait and see before taking any actions with dicamba products. We’ll keep you posted on any new legal developments. Read the court's decision in National Family Farm Coalition et al v. U.S. EPA here.
Although many of us are quarantined at home these days, the gears of the legal world are still turning. Here’s our gathering of recent notable news and legal developments:
Our Farm Office is open Monday night! Join us for the Farm Office’s live online office hours this Monday night from 8—9:30 p.m. Our team of experts will provide updates on the Paycheck Protection Program and the dairy economy and discuss COVID-19 macro-economic and export impacts, BWC dividends, property tax concerns, potential legal issues arising from COVID-19, and other issues you want to discuss. Register at https://go.osu.edu/farmofficelive.
What’s the deal with dicamba? Our partner, the National Agricultural Law Center, is hosting a free webinar on dicamba litigation on Wednesday, April 15 at noon EST. "The Deal with Dicamba: An Overview of Dicamba Related Litigation," will feature attorney Brigit Rollins, who will review each of the dicamba lawsuits, the claims made by the plaintiffs, and what the outcome of each suit could mean for dicamba use in the United States. Go here to learn more.
Walmart sued for employee’s COVID-19 death. We’ve been wondering when we’d start seeing COVID-19 lawsuits, and the answer is now. On Monday, the estate of a Walmart employee in Illinois who died from COVID-19 sued the company for negligence and wrongful death. The complaint alleges that Walmart failed to properly clean the store or provide employees with masks, gloves, antibacterial wipes and other protective equipment, knew that employees were exhibiting COVID-19 signs and symptoms, and did not screen new employees for COVID-19. A second employee at the same store has also died of the virus. Read the complaint here.
Shell eggs go to market. The FDA issued guidance that eases up packaging and labeling requirements during the COVID-19 pandemic for shell eggs sold directly to consumers in retail food establishments. The agency explained that it made the change because plenty of shell eggs are available to meet increased consumer demands, but properly labeled retail packaging for the eggs is not. See the guidance here.
EPA’s glyphosate approval is challenged. Glyphosate, used in the weed killer Roundup, is in the news again. This time, the controversy surrounds the EPA’s decision in January 2020 to allow glyphosate to continue being used in the interim while the agency conducts its mandatory 15-year re-approval review. Although EPA has yet to make its re-approval decision, two groups of plaintiffs have petitioned the Ninth Circuit Court of Appeals for an invalidation of the EPA’s decision allowing continued use in the interim. Plaintiffs argue that the decision violates both the Federal Insecticide, Fungicide, and Rodenticide Act and the Endangered Species Act because the EPA has not gathered enough information to prove that glyphosate is safe for humans, the environment, and endangered species. You can read the petitions here and here, and EPA’s interim decision here.
No rehearing for RFS litigation. We reported previously that the Tenth Circuit Court of Appeals held the EPA in violation of the Renewable Fuel Standard (RFS) when it granted RFS blending waivers to three small refineries. While the Trump administration did not appeal the court’s decision, two of the oil refiners requested a rehearing before the full panel of Tenth Circuit judges. This week, those requests were rejected by the Tenth Circuit, starting a 90-day period during which the refiners may petition for a hearing before the U.S. Supreme Court.
ODNR suspends hunting and fishing license sales for non-residents. The Ohio Department of Natural Resources announced this week that it is “temporarily suspending the sale of non-resident hunting and fishing licenses until further notice” to further discourage travel into the state. ODNR has no set date to lift the suspension; it will be in place as long as state COVID-19 orders dictate. Read ODNR’s press release here.
BWC gives dividends and deferrals. The Ohio Bureau of Workers’ Compensation board decided yesterday to pay dividends to employers for BWC premiums to the tune of up to $1.6 billion. Checks will go out to employers later in April, and will equal approximately 100% of the BWC premiums paid in their 2018 policy years. The agency is also allowing employers to delay unpaid premium installments due for March through May until June 1, 2020 and will not lapse coverage or assess penalties for amounts not paid due to the COVID-19 pandemic. See this FAQ for details.
Valentine’s Day was indeed a sweet day for Bader Farms, a peach farm in Missouri that claimed that dicamba products by Monsanto/Bayer and BASF drifted onto its property and injured 20,000 of its peach trees over 700 acres. A federal jury agreed and awarded the farm $15 million in compensatory damages. The following day, the jury gave the farm another $250 million in punitive damages against Bayer and BASF, bringing the total award to $265 million.
In 2016, Bader Farms was the first to file a dicamba drift lawsuit against Monsanto. A summary of the lawsuit from our partner, the National Agricultural Law Center, explains that the farm’s claim alleged widespread damage to the peach orchards and a multi-million dollar financial loss. At the center of Bader Farms’ original complaint was Monsanto’s genetically modified Roundup Ready 2 Xtend soybeans and Bollgard II Xtend cotton seeds (“Xtend crops”), dicamba-resistant seeds that Bader Farms alleged were released without an accompanying EPA-approved dicamba herbicide in 2015 and 2016. The farm argued that by selling the Xtend crop seeds without a corresponding herbicide, it was foreseeable to Monsanto that farmers would use old, highly volatile, drift-prone dicamba that had a strong chance of damaging neighboring crops.
Bader Farms later added BASF as a defendant to the case and also added new complaints for dicamba-related damage it suffered during the 2017 growing season. Bader Farms stated that Monsanto and BASF had worked together to manufacture, market, and sell dicamba-based products that they knew would cause harm.
The jury in the federal lawsuit ruled in favor of Bader Farms on all counts. Specifically, the jury concluded that Monsanto was negligent by releasing dicamba-tolerant seeds before releasing the herbicide. The jury also determined that both Monsanto and BASF were negligent because they issued new dicamba products that drifted off-target although the companies claimed that the products were less likely to drift. Important to the punitive damage award, the jury found that Monsanto and BASF had engaged in a “conspiracy to create an ecological disaster to increase profits.”
The Bader Farms case is the first of many dicamba-based cases against Monsanto/Bayer and BASF, combined last year into Multi-District Litigation involving both a Crop Damage Class Action Master Complaint and a Master Antitrust Action Complaint. For an excellent review of the dicamba cases, see the National Agricultural Law Center’s series on “The Deal with Dicamba,” available at https://nationalaglawcenter.org/the-deal-with-dicamba-part-three/.
Written by: Evin Bachelor, Law Fellow, and Ellen Essman, Sr. Research Associate
We’re back from the American Agricultural Law Association’s 2018 symposium, which was held in Portland, Oregon this year. We had the chance to hear from lawyers and experts from across the nation on various legal issues facing agriculture. Stay tuned to the Ag Law Blog for an update on what we learned at the symposium, but first, here’s the latest in agricultural law news:
Vote to designate watersheds in distress tabled by Ohio Soil and Water Conservation Commission. As recently reported in the Ag Law Blog, the Ohio Soil and Water Conservation Commission held a meeting this week to discuss whether to designate certain sub-watersheds in the Western Lake Erie Basin as “in distress.” Such designation would trigger additional management and reporting requirements on farmers in affected watersheds. The Commission voted 4-3 to table the discussion and wait for the Joint Committee on Agency Rule Review (JCARR) to examine the Ohio Department of Agriculture’s proposed rule changes next month. This week’s vote maintains the status quo without extending the “in distress” designation to other watersheds.
FDA releases two FSMA draft guidance documents. The Food and Drug Administration recently released draft guidance documents explaining how to follow rules under the Food Safety Modernization Act (FSMA). One document, titled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce,” provides guidance on how to follow the Preventive Controls Rule under FSMA. “Fresh-cut produce,” is defined as “any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field without additional processing.” The guidance would affect manufacturers, processors, packers, and holders of fresh-cut produce. The document covers current good manufacturing practices, as well as “new requirements for hazard analysis and risk-based preventive controls.” The draft guidance document, in addition to information on how to submit a comment on the guidance, is available here.
The second draft guidance document is titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry.” This document provides guidance on how to follow FSMA’s Produce Safety Rule. The guidance would affect produce farms. The guidance covers personnel qualifications and training, health and hygiene practices, biological soil amendments, contamination from domesticated and wild animals, suggestions for practices during the growing, harvesting, packing, and holding of produce, sanitation of equipment, recordkeeping on produce farms, and other topics. According to a press release about the two guidance documents, FDA will be holding a series of four public meetings at various places around the U.S. to discuss the second draft guidance document with those affected. FDA will be announcing the details about the meetings in the Federal Register soon.
It is important to remember that these are draft guidance documents. Furthermore, guidance documents are just that—guidance. In other words, the documents are there as suggestions on how to follow rules, and “do not establish legally enforceable responsibilities.”
EPA renews dicamba registration for cotton and soybeans, and updates labels. On October 31, 2018, the United States Environmental Protection Agency (EPA) shared its decision on changes to applying dicamba, the much discussed herbicide. EPA renewed the herbicide’s registration until December 20, 2020 for application to growing (what EPA terms “over-the-top”) dicamba-resistant cotton and soybean plants.
Below is EPA’s list of label alterations to dicamba products for the 2019-2020 growing season:
- 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 4 to 2 (soybeans remain at 2 OTT applications)
- Applications will be allowed only from 1 hour after sunrise to 2 hours before sunset
- In counties where endangered species may exist, the downwind buffer will remain at 110 feet and there will be a new 57-foot buffer around the other sides of the field (the 110-foot downwind buffer applies to all applications, not just in counties where endangered species may exist)
- Clarify training period for 2019 and beyond, ensuring consistency across all three products (Xtendimax with Vapor Grip Technology, Engenia Herbicide, DuPont FeXapan Herbicide)
- 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
- Label clean up and consistency to improve compliance and enforceability
Judge reduces jury verdict against Bayer’s Monsanto. As we predicted in a previous edition of The Harvest, Bayer’s Monsanto quickly challenged a quarter billion dollar verdict granted by a San Francisco jury to a plaintiff who alleged that Monsanto’s Roundup weed killer caused his cancer. Monsanto asked the judge to reconsider the jury’s verdict, and on Monday, October 22nd, the judge reduced the punitive damages portion of the jury verdict from $250 million to $39.25 million. The judge accepted the jury’s finding that Monsanto acted with malice, but said that the evidence did not justify a quarter billion dollar award. The judge did uphold the $39.25 million compensatory damages verdict. In total, the plaintiff would receive a $78.5 million award. Just this week, the plaintiff accepted the reduction in the award, saying that he will not ask the judge to reconsider the decision on damages. However, the litigation seems likely to continue, so stay tuned to the Ag Law Blog for more updates about the glyphosate and Roundup lawsuits.
Blockchain: the future of information sharing? We keep hearing about Blockchain technology, but what is it? Blockchain is a digital system that allows users to securely transfer information and money without an intermediary to facilitate the transfer. The transfers are recorded and timestamped, and the information contained in the “blocks” cannot be modified without the agreement of a majority of network users. The system is decentralized in nature, meaning that the information is not stored in one location but is rather is stored on servers across the globe. This makes the system more secure and less prone to modification because no single user can control the blockchain. Its early uses were for digital cryptocurrencies like Bitcoin, but its uses have expanded into information. The system has a potential in almost every sector of the economy, agriculture included. For example, Walmart announced plans to utilize blockchain to quickly track products like produce all the way from the ground to the consumer. By tracking information on foods like produce, companies like Walmart hope to be able to quickly determine sources of contamination in its food supply. This would not only be a way to save lives, but to also not have to waste produce that was not contaminated. For more information on Blockchain, here is a webinar from the National Agricultural Law Center that goes more in depth on what blockchain is, how it works, and how it can be utilized to help agriculture.