FIFRA

By: Ellen Essman, Monday, August 10th, 2020

Welcome to August! Despite the fact that most of us haven’t seen much besides the inside of our homes lately, the world still turns, which is also true for the gears in Washington D.C.  In this issue of the Ag Law Harvest, we will take a look at some recently introduced and passed federal legislation, as well as a proposed federal rule.

Great American Outdoors Act is a go.  The Great American Outdoors Act, one of the last pieces of legislation introduced by the late Representative John Lewis, was signed into law by the President on August 4.  The new law secures funding for deferred maintenance projects on federal lands.  The funding will come from 50% of the revenues from oil, gas, coal, or alternative energy development on federal lands.  The funding will be broken down between numerous agencies, with 70% to the National Park Service each year, 15% to the Forest Service, 5% to the U.S. Fish and Wildlife Service, 5% to the Bureau of Land Management, and 5% to the Bureau of Indian Education.  You can read the law in its entirety here.

A meat processing slowdown for worker safety? In addition to the Great American Outdoors Act, numerous bills have been introduced to help farmers, ag-related businesses, and rural areas in the wake of COVID-19.  For instance, in early July, Ohio’s own Representative from the 11th District, Marcia Fudge, introduced H.R. 7521, which would suspend increases in line speeds at meat and poultry establishments during the pandemic.  Notably, if passed, the bill would “suspend implementation of, and conversion to the New Swine Slaughter Inspection System,” which has been planned since the USDA published the final rule in October of 2019. It would also make the USDA suspend any waivers for certain establishments related to increasing line speed.  The resolution was introduced to protect the safety of workers, animals, and food.  In theory, slower line speeds would make it easier for workers to social distance. This is especially important in the wake of outbreaks among workers at many processing plants.  On July 28, Senator Cory Booker introduced a companion bill in the Senate.

Will livestock markets become more competitive?  On July 9, a group of Representatives from Iowa introduced H.R. 7501.  The bill would amend the Agricultural Marketing Act of 1946 “to foster efficient markets and increase competition and transparency among packers that purchase livestock from producers.  To achieve this outcome, the bill would require packers to obtain at least 50% of their livestock through “spot market sales” every week.  This means that the packers would be required to buy from producers not affiliated with the packer. “Unaffiliated producers” would have less than a 1 percent equity interest in the packer (and vice versa), no directors, employees, etc. that are directors, employees, etc. of the packer, and no fiduciary responsibility to the packer.  Additionally, the packer would not have an equity interest in a nonaffiliated producer.  Basically, this bill would make it easier for independent producers to sell to packers. This bill is a companion to a Senate Bill 3693, which we discussed in a March edition of the Ag Law Harvest. According

New bill would make changes to FIFRA.  Just last week, a new bill was proposed in both the House and Senate that would alter the Federal Insecticide, Fungicide, and Rodenticide Act.  The bill is called the “Protect America’s Children from Toxic Pesticides Act of 2020.” In a press release, the sponsoring Senator, Tom Udall, and Representative, Joe Neguse, explained that the proposed law would ban organophosphate insecticides, neonicotinoid insecticides, and the herbicide paraquat, which are linked to harmful effects in humans and the environment.  Furthermore, the law would allow individuals to petition the EPA to identify dangerous pesticides, close the loopholes allowing EPA to issue emergency exemptions and conditional registrations to use pesticides before they are fully vetted, allow communities to pass tougher laws on pesticides without state preemption, and press the pause button on pesticides found to be unsafe by the E.U. or Canada until they undergo EPA review.  Finally, the bill would make employers report pesticide-caused injuries, direct the EPA to work with pesticide manufacturers on labeling, and require manufacturers to include Spanish instructions on labels.  You can read the text of the bill here

USDA AMS publishes proposed Organic Rule.  Moving on to federal happenings outside Congress, the USDA Agricultural Marketing Service published a proposed rule on August 5. The rule would amend current regulations for organic foods by strengthening “oversight of the production, handling certification, marketing, and sale of organic agricultural products.” The rule would make it easier to detect any fraud, trace organic products, and would make organic certification practices for producers more uniform.  Anyone interested in commenting on this proposed rule has until October 5, 2020 to do so.  You can find information on how to submit a comment on the website linked above. 

Welcome to August! Despite the fact that most of us haven’t seen much besides the inside of our homes lately, the world still turns, which is also true for the gears in Washington D.C.  In this issue of the Ag Law Harvest, we will take a look at some recently introduced and passed federal legislation, as well as a proposed federal rule.

Great American Outdoors Act is a go.  The Great American Outdoors Act, one of the last pieces of legislation introduced by the late Representative John Lewis, was signed into law by the President on August 4.  The new law secures funding for deferred maintenance projects on federal lands.  The funding will come from 50% of the revenues from oil, gas, coal, or alternative energy development on federal lands.  The funding will be broken down between numerous agencies, with 70% to the National Park Service each year, 15% to the Forest Service, 5% to the U.S. Fish and Wildlife Service, 5% to the Bureau of Land Management, and 5% to the Bureau of Indian Education.  You can read the law in its entirety here.

A meat processing slowdown for worker safety? In addition to the Great American Outdoors Act, numerous bills have been introduced to help farmers, ag-related businesses, and rural areas in the wake of COVID-19.  For instance, in early July, Ohio’s own Representative from the 11th District, Marcia Fudge, introduced H.R. 7521, which would suspend increases in line speeds at meat and poultry establishments during the pandemic.  Notably, if passed, the bill would “suspend implementation of, and conversion to the New Swine Slaughter Inspection System,” which has been planned since the USDA published the final rule in October of 2019. It would also make the USDA suspend any waivers for certain establishments related to increasing line speed.  The resolution was introduced to protect the safety of workers, animals, and food.  In theory, slower line speeds would make it easier for workers to social distance. This is especially important in the wake of outbreaks among workers at many processing plants.  On July 28, Senator Cory Booker introduced a companion bill in the Senate.

Will livestock markets become more competitive?  On July 9, a group of Representatives from Iowa introduced H.R. 7501.  The bill would amend the Agricultural Marketing Act of 1946 “to foster efficient markets and increase competition and transparency among packers that purchase livestock from producers.  To achieve this outcome, the bill would require packers to obtain at least 50% of their livestock through “spot market sales” every week.  This means that the packers would be required to buy from producers not affiliated with the packer. “Unaffiliated producers” would have less than a 1 percent equity interest in the packer (and vice versa), no directors, employees, etc. that are directors, employees, etc. of the packer, and no fiduciary responsibility to the packer.  Additionally, the packer would not have an equity interest in a nonaffiliated producer.  Basically, this bill would make it easier for independent producers to sell to packers. This bill is a companion to a Senate Bill 3693, which we discussed in a March edition of the Ag Law Harvest. According

New bill would make changes to FIFRA.  Just last week, a new bill was proposed in both the House and Senate that would alter the Federal Insecticide, Fungicide, and Rodenticide Act.  The bill is called the “Protect America’s Children from Toxic Pesticides Act of 2020.” In a press release, the sponsoring Senator, Tom Udall, and Representative, Joe Neguse, explained that the proposed law would ban organophosphate insecticides, neonicotinoid insecticides, and the herbicide paraquat, which are linked to harmful effects in humans and the environment.  Furthermore, the law would allow individuals to petition the EPA to identify dangerous pesticides, close the loopholes allowing EPA to issue emergency exemptions and conditional registrations to use pesticides before they are fully vetted, allow communities to pass tougher laws on pesticides without state preemption, and press the pause button on pesticides found to be unsafe by the E.U. or Canada until they undergo EPA review.  Finally, the bill would make employers report pesticide-caused injuries, direct the EPA to work with pesticide manufacturers on labeling, and require manufacturers to include Spanish instructions on labels.  You can read the text of the bill here

USDA AMS publishes proposed Organic Rule.  Moving on to federal happenings outside Congress, the USDA Agricultural Marketing Service published a proposed rule on August 5. The rule would amend current regulations for organic foods by strengthening “oversight of the production, handling certification, marketing, and sale of organic agricultural products.” The rule would make it easier to detect any fraud, trace organic products, and would make organic certification practices for producers more uniform.  Anyone interested in commenting on this proposed rule has until October 5, 2020 to do so.  You can find information on how to submit a comment on the website linked above. 

By: Peggy Kirk Hall, Thursday, July 23rd, 2020

In a decision that turns largely on scientific methodology and reliable data, the Ninth Circuit Court of Appeals yesterday allowed continued registration of the Enlist Duo herbicide developed by Dow AgroScience (Corteva).  Unlike last month’s decision that vacated registrations of three dicamba herbicides, the two-judge majority on the court held that substantial evidence supported the EPA’s decision to register the herbicide.  Even so, the court sent one petition back to the EPA to further consider the impact of Enlist Duo on monarch butterflies in application areas. One dissenting judge would have held that the science used to support the Enlist Duo registration violates the Endangered Species Act.

The case began in 2014, when the same organizations that challenged the dicamba registrations (National Family Farm Coalition, Family Farm Defenders, Beyond Pesticides, Center for Biological Diversity, Center for Food Safety and Pesticide Action Network North America) and the Natural Resources Defense Council each filed petitions challenging the EPA’s registration of Enlist Duo.  The EPA later amended the registration in 2015 and 2017, eventually allowing use of the herbicide on corn, soybeans and cotton in 34 states.  The petitioners challenged the 2015 and 2017 registrations as well, and the Ninth Circuit consolidated the challenges into the case at hand.

The court’s opinion begins with an explanation of why it agreed with the parties who brought the challenges that they had the legal right to do so, or had “associational standing.”   Likely of higher interest to our readers is how the court answered the questions of whether the EPA adequately examined the potential impacts of Enlist Duo under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the federal Endangered Species Act (ESA).  Here’s what the court had to say about the petitioners’ claims under each law:

The FIFRA claims.  The monarch butterfly issue was the only successful FIFRA claim advanced by the petitioners.  The court agreed that the EPA didn’t properly assess adverse harm to monarch butterflies that would result from increased 2,4-D use on milkweed in application fields, despite evidence suggesting that the butterflies might be adversely affected.  The EPA stated that it didn’t do so because the approval of Enlist Duo would not change the amount of milkweed being controlled by herbicides—those milkweeds would still be controlled with or without Enlist Duo.  The court disagreed, stating that FIFRA required the agency to determine whether any effect was “adverse” before then determining whether the effect on the environment was unreasonable, which EPA didn’t do in regard to the monarch butterfly.

The court rejected all of the petitioners’ other arguments under FIFRA:

Applicable standards.  Several claims that the EPA applied the wrong FIFRA registration standards failed.  The agency correctly used the broader and more stringent standard, which was to determine whether the registration would cause any unreasonable adverse effects on the environment.   

Increased glyphosate use.  Petitioners also argued that the EPA erred in determining that approval of Enlist Duo would not cause unreasonable adverse effects on environment because glyphosate was already being used.  The registration would only impact which glyphosate was being used but not how much glyphosate was in use.  The court agreed with EPA’s assertion that due to the “nearly ubiquitous use” of glyphosate across the country before the approval of Enlist Duo registration, there would not be an increase in overall glyphosate use and no increased risks.   Interestingly, the court distinguished increased use from new data about glyphosate use, stating that “this does not mean, of course, that new data about glyphosate will go unconsidered….”

Volatility risk.  The court also rejected volatility risk arguments, one of the science-heavy parts of the opinion (begin at page 37 for a good read).  The EPA had concluded the type of 2,4-D in Enlist Duo exhibits lower volatility and off-site vapor drift than other forms of 2,4-D.  EPA reached this conclusion based several studies and data points:  a laboratory study that examined degree of visual damage, six publicly available studies assessing plant growth and survival damage, data from a vapor flux study used to perform computer modeling to determine dose level and air concentration in order to predict adverse damages to plants off-field, a second type of modeling that assesses drift of wet and dry depositions, and atmospheric monitoring data.  Petitioners claimed limitations to the studies and methodology used, contradictions between EPA scientists, failure to follow regulatory guidelines and to consider large enough field sizes in its modeling.  The court commented that the evaluation of volatility “probably could have been better,” but found no evidence showing that EPA’s conclusion was wrong or that volatility fears had materialized since approval of the herbicide.  The court explained that the agency may apply its expertise to draw conclusions from probative preliminary data and “it is not our role to second-guess EPA’s conclusion.” 

Mixing risks.  Petitioners also argued that Dow intended to mix Enlist Duo with glufosinate and EPA failed to account for the synergistic effect of such mixing.  With no evidence other than an abandoned patent application for a mixed product by Dow, the court held that FIFRA doesn’t require an analysis of theoretical tank mixing but only that which is contemplated on the label. 

Nearly all of the EPA’s FIFRA decisions were supported by substantial evidence, the court concluded, with the exception of the monarch butterfly analysis. 

The ESA claims.   Science is a recurring theme in the court’s analysis of the petitioners’ ESA arguments, and also the source of sharp disagreement on the court.  ESA’s section 7 requires a determination of the biological impacts of a proposed action.  ESA consultation among the agencies is required if determined that an agency’s action “may affect” a listed species or critical habitat in an “action area.”   The petitioners claimed that EPA failed in its determination on several grounds, requiring the court to review whether the EPA’s determination was arbitrary, capricious, an abuse of discretion, or contrary to law.  Here are the arguments, and the court’s responses:

“No effect” finding.  The petitioners argued that the EPA erred in determining that Enlist Duo approval would have “no effect” on plant and animal species and the court responded with another lengthy science-heavy discussion of “risk quotient” methodology and legal requirements  to use the “best scientific and commercial data available.”  The EPA employed a risk quotient methodology to conclude that there would be exposure to the herbicide but that such exposure would not lead to an effect on plants and animals.  The two judges in the majority were willing to defer to the agency on this conclusion and its dependence on the risk quotient methodology, but Judge Watford strongly disagreed.  Pointing out that the National Academy of Sciences had advised the EPA that the risk quotient method was “scientifically unsound,” the dissent concluded that the data derived from the methodology did not qualify as “scientific data” and therefore violated the ESA.   The majority stated that the risk quotient methodology doesn’t violate the duty to use the best scientific and commercial data available, which means that the EPA must not disregard available scientific evidence that is better and does not require the agency to conduct new tests or make decisions on data that doesn’t exist.   Deference to the agency was warranted, said the majority, and restraint against second guessing or using the court’s judgment.

Action area.   For its ESA determination, the EPA limited the “action area” to treated fields, while petitioners argued that the herbicide would drift beyond treated fields.  Again turning to the EPA’s science, the court held that the agency had science-based reasons for limiting the target area.  The EPA had appropriately accounted for drift through empirical data, mitigation measures, and label restrictions and no evidence in the record supported that the agency had made an error.

Critical habitat.  The final argument advanced by petitioners was that EPA did not meet its duty to insure that there would be no “adverse modification” of critical habitat from the registration.  Although there were 154 species with critical habitats in the states where Enlist Duo would be approved, EPA concluded that 176 of the species would not be in corn, cotton or soybean fields.  Of the eight species remaining, the agency determined that there would be no modification to their critical habitats as a result of Enlist Duo registration because none of the species’ essential features or “primary constituent elements” were related to agriculture.  Petitioners challenged the methodology EPA employed to reach this conclusion, but the court once again disagreed and deferred to the agency.

What remedy?

With only the monarch butterfly impact analysis in need of further study, the Ninth Circuit declined the petitioners’ request to vacate the Enlist Duo registration.   The court chose instead to remand the petition without vacating the registration, stating that the EPA’s failure to consider harm to monarch butterflies was technical and not a “serious” error.  Pointing also to the “disruptive” consequences of removing a pesticide that has been in use for over five years, the court stated that vacatur was not warranted when the EPA had substantially complied with FIFRA and fully complied with the ESA.

What’s next?

Enlist Duo registration will continue.  The EPA must address evidence that its destruction of milkweed in fields harms monarch butterflies, however.  The court advised the agency to “move promptly” in doing so.

Further action by the petitioners is likely.  According to correspondence with DTN, the petitioners are disappointed and will fight the decision.  They will likely also follow the EPA’s science quite closely as it reexamines the monarch butterfly issue.

Read the Ninth Circuit's decision National Family Farm Coalition et al v. U.S. EPA and Natural Resources Defense Council v. Wheeler, here.

By: Peggy Kirk Hall, Monday, June 22nd, 2020

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.

By: Peggy Kirk Hall, Tuesday, June 09th, 2020

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:

  1.  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.”

  1.  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.

  1. 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.

  1. 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.”

  1. 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.

  1. 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.” 

Final Order

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Now what? 

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.

Posted In: Biotechnology, Crop Issues, Environmental
Tags: dicamba, FIFRA, EPA
Comments: 0
By: Peggy Kirk Hall, Thursday, June 04th, 2020

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.

 

 

Subscribe to RSS - FIFRA