Biotechnology

Did you know that Giant Panda cubs can be as small as a stick of butter?  A panda mother is approximately 900 times bigger than her newborn cub, which can weigh less than 5 ounces.  This is like an 8-pound human baby having a mother that weighed 7,200 pounds – this size difference may explain why so many panda cubs die from accidentally being crushed by their mothers.  However, not everything is doom and gloom for the Giant Panda.  Chinese officials have officially downgraded pandas from “endangered” to “vulnerable.”  Although the International Union for Conservation of Nature re-labelled, the Panda as “vulnerable” in 2016, China wanted to make sure that the population of its national treasure continued to grow before downgrading the panda’s classification.  

Although it seems as though pandas are thriving thanks to conservation efforts in China, not all animal species in China are so lucky.  This week’s Ag Law Harvest takes a trip around the world to bring you domestic and international agricultural and resource issues.  We take a look at court decisions, Congress’ latest actions, China’s struggle with African Swine Fever, and President Biden’s latest executive order. 

Iowa Supreme Court Dismisses Raccoon River Lawsuit.  Environmental organizations (“Plaintiffs”) filed a lawsuit against the state of Iowa and its agencies (“Defendants”) asking the court to compel Defendants to adopt legislation that would require Iowa farmers to implement practices that would help reduce the levels of nitrogen and phosphorus in Raccoon River.  The Plaintiffs argued that Defendants violated their duty under the Public Trust Doctrine (“PTD”), which is a legal doctrine that requires states to hold certain natural resources in trust for the benefit of the state’s citizens.  Defendants argued that Plaintiffs lacked standing to bring the lawsuit.  The Iowa Supreme Court agreed with Defendants and found that a ruling in Plaintiffs’ favor would not necessarily remediate Plaintiffs’ alleged injuries, and therefore the Plaintiffs lacked standing to bring the lawsuit.  The Iowa Supreme Court also found that Plaintiffs’ issue was a nonjusticiable political question.  The political question doctrine is a principle that helps prevent upsetting the balance of power between the branches of government.  Under the doctrine, courts will not decide certain issues because they are better suited to be decided by another branch of government.  In this case, the court reasoned that Plaintiffs’ issue was better suited to be resolved through the legislative branch of government, not the judicial branch.  The Iowa Supreme Court decision is significant because, as it stands, agricultural producers in the Raccoon River Watershed will not be required to adopt any new practices but the decision leaves it up to Iowa’s legislature to determine whether farmers should be required to adopt new practices under the PTD to help reduce nitrogen and phosphorus in Raccoon River.  

U.S. House of Representatives’ spending bill increases focuses on climate action and environmental protection.  Before the July 4th break, the United States House Appropriations Committee approved the first of its Fiscal Year 2022 (“FY22”) funding bills.  Included in these bills is the agriculture funding bill, which will be sent to the House floor for full consideration.  The bill provides $26.55 billion in the discretionary funding of agencies and programs within the USDA, FDA, the Commodity Futures Trading Commission, and the Farm Credit Administration – an increase of $2.851 billion from 2021.  In total, the agriculture funding bill includes $196.7 billion for both mandatory and discretionary programs.  The bill focuses on: (1) rural development and infrastructure – including rural broadband; (2) food and nutrition programs to help combat hunger and food insecurity; (3) international food assistance to promote U.S. agricultural exports; (4) conservation programs to help farmers, ranchers, and other landowners protect their land; (5) ag lending; (6) climate-related work to help research and remedy the climate crisis; and (7) enforcement of environmental programs.  The agriculture spending bill will, however, have to be reconciled with any spending bill produced by the U.S. Senate.

U.S. House Agriculture Committee advances rural broadband bill.  The House Agriculture Committee (the “Committee”) unanimously voted to advance the Broadband Internet Connections for Rural America Act (the “Act”), which would authorize $4.5 billion in annual funding, starting in fiscal year 2022, for the Broadband ReConnect Program (the “Program”) through fiscal year 2029.  The existing Program is set to expire on June 30, 2022.  To demonstrate Congress’ commitment to expanding rural broadband, the Program was only given $742 million in 2021.  It is unclear whether the Act will be included in the infrastructure package that is currently being negotiated between Congress and the White House.  Under the Act, the USDA must give the highest priority to projects that seek to provide broadband service to unserved communities that do not have any residential broadband service with speeds of at least 10/1 Mbps.  The USDA will then prioritize communities with less than 10,000 permanent residents and areas with a high percentage of low-income families.

Small hog farmers in China no longer required to seek environmental approval.  China is the world’s largest pork producer and over the past few years, its hog herds have been decimated.  A deadly African Swine Fever (“ASF”) has wiped out about half of China’s hog herds, especially affecting small farmers.  According to Reuters, China relies heavily on small farmers for its pork output, but because of ASF, small farmers have been left with little to no product and mass amounts of debts.  Further, Chinese farmers are hesitant to rebuild their herds because ASF is an ongoing risk and farmers stand to lose everything if they continue to raise diseased hogs.  Addressing these concerns, China’s agriculture ministry will no longer require small hog farmers to get environmental approval from the government before breeding their hogs.  China hopes to reduce the costs and red tape for small farmers as China tries to incentivize small farmers to rebuild their hog herds.  African Swine Fever is a highly contagious and deadly viral disease affecting both domestic and feral swine.  The ASF poses no threat to human health but can decimate domestic hog populations.  Germany has recently reported its first two cases of ASF in domestic hogs.  Currently, ASF has not been found within the United States, and the USDA hopes to keep it that way.  To learn more about ASF, visit the USDA’s Animal and Plant Health Inspection Service website. 

President Biden signs executive order to reduce consolidation in agriculture.  President Biden’s recent Executive Order on Promoting Competition in the American Economy seeks to address inadequate competition within the U.S. economy that the administration believes holds back economic growth and innovation.  The Order includes more than 70 initiatives by more than a dozen federal agencies to promote competition.  With respect to agriculture, the Order seeks to break up agricultural markets “that have become more concentrated and less competitive.”  The Biden Administration believes that the markets for seeds, equipment, feed, and fertilizer are dominated by a few large companies which negatively impacts family farmers and ranchers.  The Biden Administration believes that the lack of competition increases the costs of inputs for family farmers all while decreasing the revenue a family farmer receives.  The Order directs the USDA to consider issuing new rules: (1) making it easier for farmers to bring and win lawsuits under the Packers and Stockyards Act; (2) prohibiting chicken processors from exploiting and underpaying chicken farmers; (3) adopting anti-retaliation protections for farmers who speak out about a company’s bad practices; and (4) defining when meat producers can promote and label their products as a “Product of the USA.”  The Order also requires the USDA to develop a plan to increase opportunities for small farmers to access markets and receive a fair return and encourages the Federal Trade Commission to limit when equipment companies can restrict farmers from repairing their own farm machinery.  Follow this link to learn more about President Biden’s recent Executive Order.

Written by Ellen Essman and Peggy Hall

This edition of the Ag Law Harvest has a little bit of everything—Ohio and federal legislation responding to COVID issues, new USDA guidance on bioengineered foods, and a judicial review of Bayer’s Roundup settlement.  Read on to learn about the legal issues currently affecting agriculture.  

Ohio COVID-19 immunity bill stalls.  While the Ohio House and Senate agree with the concept of immunity for COVID-19 transmissions, the two chambers don’t yet see eye-to-eye on the parameters for COVID-19 liability protection.  H.B. 606, which we reported on here, has passed both the House and Senate, but the Senate added several amendments to the legislation.  The House won’t be addressing those amendments soon because it’s in recess, and doesn’t plan to return for business until at least September 15.   The primary point of disagreement between the two bills concerns whether there should be a rebuttable presumption for Bureau of Workers’ Compensation coverage that certain employees who contract COVID-19 contracted it while in the workplace.  The Senate amendment change by the Senate concerns exemption from immunity for "intentional conduct," changed to "intentional misconduct.”  Currently, there is not a plan for the House to consider the Senate’s amendments before September 15.

Lawmakers propose bill to avoid more backlogs at processing plants.

Most people are aware that the COVID-19 pandemic created a huge backlog and supply chain problem in U.S. meatpacking plants.  A group of bipartisan representatives in the House recently proposed the

Requiring Assistance to Meat Processors for Upgrading Plants Act, or RAMP-UP Act.  The bill would provide grants up to $100,000 to meat and poultry processing plants so the plants could make improvements in order to avoid the kind of problems caused by the pandemic in the future.  The plants would have to provide their own matching funds for the improvements.  You can find the bill here. 

Revisiting the Paycheck Protection Program, again.  In a refreshing display of non-partisanship, Congress passed legislation in late June to extend the Paycheck Protection Program (PPP).  Employers who haven’t taken advantage of PPP now have until August 8, 2020 to apply for PPP funds to cover payroll and certain other expenses.  Several senators also introduced the Paycheck Protection Program Small Business Forgiveness Act, a proposal to streamline an automatic approval process for forgiveness of PPP loans under $150,000, but there’s been little action on the bill to date.  Meanwhile, the American Farm Bureau Federation is in discussion with the Senate on its proposal for other changes to PPP that would expand access to PPP for agriculture.

More clarification for bioengineered food disclosure. You may recall that the National Bioengineered Food Law was passed by Congress in 2016.  The legislation tasked USDA with creating a national mandatory standard for disclosing bioengineered foods. The standard was implemented at the beginning of 2020, but USDA still needed to publish guidance on validating a refining process and selecting an acceptable testing method.  On July 8, 2020, that guidance was published. The guidance provides steps for industry to take when validating a food refining process under the rule.  A lot of food refining processes remove traces of modified genetic material. So, if a refining process is validated, there is no further need to test for bioengineered material to disclose.  The guidance also contains instructions on testing methods. Basically, “any regulated entity that is using a food on the AMS List of Bioengineered Foods and does not want to include a bioengineered food disclosure because the food or ingredient is highly refined and does not include detectable modified genetic material” should follow these testing instructions. Therefore, any entity with highly refined foods that do “not include detectable modified genetic material” should follow the recently published guidance. 

Bayer settlement proposal under scrutiny.  Last month, Bayer, the owner of Roundup, announced that it would settle around 9,500 lawsuits related to alleged injuries caused by using the product.  Not only was the proposal supposed to settle previous lawsuits, but it was also meant to address any future lawsuits stemming from purported injuries caused by Roundup.  A judge from the United States District Court for the Northern District of California recently pumped the breaks on this plan, stating that any settlement that would resolve “all future claims” against Roundup must first be approved by the court.  A hearing will be held on July 24, where the court will decide whether or not to “grant preliminary approval of the settlement.”

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.

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.

What remedy?

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.

What now?

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.