9th Circuit Court of Appeals Vacates Three Dicamba Over the Top Registrations; Market and Growers Thrown into Chaos

On June 3, 2020, the U.S. Court of Appeals for the 9th Circuit ruled that the U.S. Environmental Protection Agency (“EPA”) failed to adequately address the risks presented by three over the top (“OTT”) registrations of the herbicide dicamba as required by Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) and immediately vacated the registrations. See National Family Farm Coalition v. EPA [9th Cir. June 3, 2020].

The three registered dicamba products for which the registrations were cancelled are Bayer’s XtendiMax with VaporGrip Technology (EPA Reg. No. 524-617) [originally a Monsanto product], BASF’s Engenia Herbicide (EPA Reg. No. 7969-345) and DuPont’s FeXapan (EPA Reg. No. 352-913).  Because Syngenta’s Tavium Plus VaporGrip Technology (EPA Reg. No. 100-1623), also an OTT dicamba pro0duct, was not part of the 2018, two-year registration for the three affected products, it can still be used.

This decision is the latest development in a process stretching over five years. As glyphosate use had increased significantly over the prior ten years, so had weed resistance to glyphosate. As an alternative, industry began developing cotton and soybean varieties tolerant to dicamba. In 2015, the U.S. Department of Agriculture (“USDA”) deregulated dicamba-tolerant soybean and cotton seeds, while applications were still pending for the registration of dicamba for OTT use on such crops.

Dicamba-tolerant seed was quickly adopted by growers for the 2016 season, although no dicamba product was registered for use on such crops. Farmers apparently resorted to the unlawful use of existing dicamba products not labeled for such uses, and problems quickly developed. Dicamba is extremely toxic to broadleaf plants, including bushes and trees. It has an elevated tendency to drift and can volatize and move off-site after application. State Departments of Agriculture quickly began to receive numerous complaints of off-target damage.

In late 2016 EPA issued two-year time-limited registrations for the OTT versions of dicamba authorized for use on the dicamba-tolerant cotton and soybeans.  The new registrations were ostensibly of such reduced volatility that EPA found that the new formulations were “expected to eliminate any off-site exposures.”  Rapid adoption by growers of the tolerant seed and new formulation lead to a forty-fold increase in the use of dicamba on cotton and a four-fold increase in the use on soybeans in 2017, and use increased further in 2018.

EPA’s conclusions regarding off-target effects proved to be off-target themselves. Almost 1,300 complaints of off-target dicamba were received by state regulators in 2017, followed by some 1,400 complaints in 2018. It was estimated that by mid-July 2018, more than 1.1 million acres of non-tolerant soybeans had been damaged.

EPA and the registrants responded by further amending the dicamba label imposing stricter use conditions designed to limit off-target movement and issuing new two-year registrations in 2018. Despite the conditions added to the registration, EPA acknowledged that there would still be damage to sensitive crops and plants, including tree lines between fields but stated it could not quantify the expected damage. Plaintiffs in this case had challenged the 2016 registrations, but before the Court could rule EPA had replaced them with the 2018 registrations. The challenge then shifted to those registrations.

FIFRA is a cost-benefit statute which requires a balancing of interests. To issue a registration or grant an amendment, EPA must find that the registration “would not significantly increase the risk of any unreasonable adverse effect on the environment…taking into account the economic, social and environmental costs and benefits of the use of any pesticide.” The Court found that EPA failed to properly balance interests, having substantially understated three risks presented by the 2018 registrations and failed to even acknowledge three other risks. 

As to understated risks, the Court listed the following: that EPA under estimated the acreage that would be planted with tolerant seed and thus the quantity of dicamba that would be applied; that EPA discounted the volume of dicamba complaints to state agencies with no evidence supporting that conclusion; and that EPA failed to even try to quantify the amount of off-target damage that could be expected.

As to risks EPA ignored, the Court identified the following: that the OTT dicamba label directions had become so complex that it was likely they would not be complied with, which had already occurred with the less-complex 2016 label; that EPA had failed as FIFRA requires to assess potential economic impact of the damage that was likely to occur, and that EPA had ignored the social impacts of the decisions, including the damage to the farm community social structures caused by the neighbor-to-neighbor damage.

Having found the registration decisions in violation of FIFRA, the Court vacated the registrations. An immediate uproar spread through the registrant and grower communities as the decision comes right in the thick of the use season. Various state Department of Agriculture began issuing conflicting opinions as to whether sale or use of the product could continue. EPA responded by issuing the EPA Dicamba Cancellation Order. The Order allows the continued distribution and sale by commercial applicators, and the use of existing stocks in the possession of growers until July 31, 2020, which would be the end of the use season.

Plaintiffs immediately responded by filing a motion to hold EPA in contempt, asserting that under the Court’s vacatur of the registration EPA lacked legal authority to allow any continued sale or use as of the date of the Court’s opinion. On June 19 the Court denied the contempt motion. As EPA and industry interests pointed out, review of FIFRA cancellation orders is authorized in the Federal district courts, not the Courts of Appeal.  

As this issue was unfolding, both BASF and DuPont filed emergency intervention motions with the Court, claiming that they had been unaware that the decision was going to impact their registrations. Although that issue had been briefed by the plaintiffs, EPA and intervenor Monsanto, apparently neither BASF nor DuPont had followed this litigation closely enough to realize its potential implications. BASF has also filed a motion to have the Court withdraw its mandate, thus arguably creating an opening for BASF to seek to challenge the underlying decision by seeking en banc review by the full 9th Circuit. As of the writing of this article on June 22, this motion remains pending and briefing continues.

This saga is far from over.  The challenged registrations expire at the end of 2020, so EPA must again address the issues associated with these products.

EPA Announces Enforcement Efforts Addressing Fraudulent SARS-CoV-2 Disinfectant Claims

Each blog entry addressing the new coronavirus SARS-CoV-2 reflects the continuing onslaught of the pandemic. According to the Johns Hopkins Virus Tracker as of this writing on April 11, 2020, worldwide cases number more than 1,760,000 cases and deaths number more than 107,000. Spread across the U.S. continues, with more than 519,000 cases and 20,000 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for a significant portion of each.

The U.S. Environmental Protection Agency (EPA”) has recently announced actions to prevent the sales of products making fraudulent disinfectant claims asserting the ability to control the SARS-CoV-2 virus. In the U.S., disinfectants are regulated as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”). Each individual product must be registered with EPA as well as every state in which it is offered for sale. A violation of FIFRA, such as selling an unregistered disinfectant, carries a penalty of up to $20,288 for each offense.

EPA actions include educational efforts with major retailers and retail trade associations, as well as enforcement actions directed at specific products for which fraudulent claims are being made. EPA is coordinating with major online retailers to assist them in identifying unlawful products. Amazon has stated that it has removed from its listings more than 6 million products making illegal claims and has created algorithms to screen listings for such products.

While urging the public to report illegal products, EPA does not reveal any information regarding pending investigations or enforcement actions. Only when a matter is resolved does information become public. Nonetheless EPA has identified four products and their associated claims as examples of unlawful claims and presumably the subject of enforcement actions. They are:

  • Lanyards that claim to protect wearers from coronavirus
  • Unregistered disinfectant tablets
    • Epidemic prevention Chlorinating Tablets Disinfectant Chlorine Tablets Swimming Pool Instant Disinfection Tablets Chlorine Dioxide Effervescent Tablet Chlorine Disinfectant 100g Cozy apposite Fun Suit
    • The Flu Virus Buster, CLO2 Disinfection Sticker, Removable sterilize air purifier, Anti COVID-19, Stop Coronavirus disease infection /Influenza Buster Disinfectant 1 Box / 10 Tablets
  • Unregistered disinfectant sprays
    • Fullerene silver antibacterial solution/24 Hour Defense Hand Sanitizer Disinfectant Spray Against Corona Virus COVID- 19 Kills 99.99% Of Germs Bacteria 24 Hours of Lasting Protection Alcohol Free 50ml (1.7 fl. oz)
  • Unregistered disinfectant wipes
    • 99.9% Sterilization Wipes/16/32/48/64/96pcs Sterilization Rate of 99% Disinfection Wet Wipes and Paper Napkin Prevention of Coronavirus

For more information about EPA’s action addressed to SARS-CoV-2 and disinfectants used to control the virus, see EPA Information for Registrants Regarding Disinfectants for the Control of SARS-CoV-2

EPA Responds to Coronavirus; Reminds Registrants of Ability to Add Coronavirus to Disinfectant Product Target Pests on Expedited Basis

In response to the spreading coronavirus epidemic, the U.S. Environmental Protection Agency (“EPA”) issued a reminder to the registrant community that an expedited process is available to add the 2019-nCoV coronavirus as a target pest on appropriate hard surface disinfectant products.

 

Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) pesticide products may be used only for the control of pests identified on the product label. On August 19, 2016 EPA issued a guidance document entitled Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels.  (“Guidance”). The Guidance outlines a two-stage process for disinfectant registrants to position themselves so that emerging viral pathogens can be identified as target pests without having to pursue a formal label amendment or supply efficacy data on the specific emerging pathogen.  EPA has now announced that the process is available to add the 2019-nCoV virus as a target pest.

 

In order to take advantage of this option, a disinfectant registrant must have first pursued a formal amendment adding a specific emerging pathogen to its label. Once so positioned, the registrant may communicate through off-label channels that the product may be used for a similar, previously unidentified emerging pathogen. Coronaviruses are enveloped viruses, which are among the more easily viruses controlled on hard surfaces. To utilize this mechanism in this instance registrants must have previously added a different enveloped virus to the label.

 

To qualify for being promoted for a new emerging pathogen, the organism must either be appearing in a human or animal population for the first time or be rapidly increasing in scale or geographic range. EPA requires that the U.S. Centers for Disease Control (“CDC”) must have so identified the organism in question, and that the virus presents a survival risk on hard surfaces. CDC has done so for 2019-nCoV. See Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV)

 

Once qualified, registrants are allowed to communicate to target users the ability to employ their disinfectants for the control of 2019-nCoV. These off-label mechanisms can include technical literature distributed exclusively to health care facilities, physicians, nurses and public health officials, as well as consumer information sources, social media and websites under the control of the registrant. The Guidance prescribes statements that may be used to convey the availability of the product for emerging pathogen control. The availability of the product for control of the emerging virus may not be added to the product label without a formal amendment.

 

 

 

 

New York Announces Administrative Elimination of Chlorpyrifos [Updated]

Despite its registration having been upheld by the U.S. Environmental Protection Agency (“EPA”), the insecticide chlorpyrifos continues to face multiple challenges to its continued use. The continued EPA registration continues to be challenged in Court by a collection of states, while California has secured the agreement of major registrants to administratively cancel all registration. Now the New York Governor has directed the Department of Environmental Conservation (“NYSDEC”) to administratively phase out most uses of the ingredient.

In New York, the legislature passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021. In a somewhat contradictory move, rather than signing the legislation, the Governor vetoed it but has directed the NYSDEC to promulgate rules largely mirroring the vetoed legislation. The Governor’s Veto Message stated that pesticides should not be regulated by legislative mandate, but instead by NYSDEC on the basis of science. The Veto Message stated that NYSDEC will act to immediately ban aerial application; most remaining uses are to be eliminated by July 1, 2021.

New York has a procedurally complex rulemaking process. To propose a rule, the moving agency must first secure approval of the State Division of the Budget. A proposed rule is then published, which must be accompanied by a series of documents assessing the impacts of the proposed rule, including a Regulatory Flexibility Analysis, a Rural Area Flexibility Analysis and a Job Impact Statement. If not finalized within a year of publication, a proposed rule expires. In fact, it often consumes most of that year to arrive and publish a final rule.  To achieve the objective of immediately eliminating aerial application, NYSDEC will need to promulgate an emergency regulation, followed by a proposed permanent rule.  The emergency rule will need to be supported by a statement justifying the need for an emergency rule.

Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That said, a state must still follow its own procedures and meet its own legal standards to support a rulemaking. Although EPA has concluded that chlorpyrifos does not present an unacceptable risk, that decision was arrived at in part by excluding epidemiological data developed by the Columbia University’s Center for Children’s Environmental Health and Mt. Sinai Hospital.  EPA asserts that the data is not valid, complete and reliable data unless EPA is granted access to the underlying raw data.  The study sponsors have refused to supply such information, claiming that to do so would violated subject confidentiality. New York will be free to include that study as a basis for its action without demanding the underlying data and is likely to do so.  Bottom line: even if challenged, done correctly New York’s anticipated rule is likely to be upheld.

With chlorpyrifos on its way out in two major states, it remains to be seen whether chlorpyrifos remains on the market, regardless of the outcome of the litigation.

 

EPA Seeks Public Comment on Pending Applications to Amend Existing Registrations to Add Hemp as a Target Site  

On August 23, 2019, the U.S, Environmental Protection Agency (“EPA”) published a notice seeking public comment on ten pending applications to amend existing registrations of agricultural pesticides to add hemp as an approved target site. See 84 Federal Register 44296 (August 23, 2019)

Interest in hemp has grown enormously since the enactment of the Agriculture Improvement Act of 2018, colloquially known as the Farm Bill. Hemp is simply another term for the cannabis plant, also known as marijuana. The Farm Bill legalized the cultivation of and interstate commerce in hemp, defined as the cannabis plant containing less than 0.03 % THC [delta-9-tetrahydrocannabinol; the psychoactive constituent of cannabis]. Plants containing above 0.3% THC remain classified as an illegal Schedule 1 drug under the Controlled Substances Act.

The legalization of what is also known as industrial hemp has been greeted with great interest by the agricultural community. In some areas, such as upstate New York, hemp is seen as an alternative crop that might help save failing dairy farms. It is also seen as a natural corollary to increased cultivation of hops to meet the demands of the burgeoning craft brewery industry.

EPA has received applications to amend the registrations of ten products from three registrants:  Agro Logistic Systems, Inc. of Diamond Bar, California; Marrone Bio Innovations of Davis, California; and Hawthorne Hydroponics of Santa Rosa California. Hawthorne Hydroponics is a subsidiary of Hawthorne Gardening, itself a subsidiary of Scotts Miracle-Gro. Hawthorne is Scott’s vehicle for creating a space servicing the cannabis industry.

The ingredients in question are mostly biologic pesticides, and all hold exemptions from the requirement for a food tolerance. The proposed use patterns are within those already approved for the products in question.

EPA acknowledged that these proposed amendments do not meet the minimum standards of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) for required public notice of pending applications. Nonetheless it stated that sufficient public interest in hemp justified seeking public comment at this initial stage, but would not continue to publicize the increasing number of applications which it expects to receive.

Comments are due September 23, 2019, and can be filed at www.regulations.gov

 

 

 

EPA Denies Chlorpyrifos Cancellation Petition; Six States File Challenge in 9thCircuit  

Despite its registration having been upheld by the U.S. Environmental Protection Agency (“EPA”), the insecticide chlorpyrifos continues to face multiple challenges to its continued use. The continued EPA registration is again being challenged in Court by a collection of states, while California is moving ahead to administratively cancel all registration and New York awaits the Governor’s decision on whether to sign legislation phasing out all use.

Petition to Cancel EPA Registrations

A Petition to Cancel the registration of chlorpyrifos was filed in 2007. Its history and related litigation is recounted in the prior blog entry EPA Obtains Stay of Execution for Chlorpyrifos from 9thCircuit Court of Appeals.On March 29, 22017 EPA denied the Petition (See 82 Fed. Reg. 16581) although it expressly reserved decision on several issues. EPA stated that those issues would be addressed in registration review, due to be completed by 2022. Petitioners sought to overturn the denial by filing a Petition for Review in the 9thCircuit U.S. Court of Appeals. On April 19, 2019, the Court had ordered EPA to respond to the merits of the Petition within 90 days.

On July 24 EPA published its final order denying all aspects of the Petition.  EPA contends that the science addressing the risks of chlorpyrifos remains uncertain, and thus there is no legal basis for canceling the registrations and revoking the tolerances. One particular point of contention is epidemiological data developed by the Columbia University’s Center for Children’s Environmental Health and Mt. Sinai Hospital.  EPA asserts that the data is not valid, complete and reliable data unless EPA is granted access to the underlying raw data.  The study sponsors have refused to supply such information, claiming that to do so would violated subject confidentiality.

In response to the Petition denial, six states – California, Maryland, Massachusetts, New York, Vermont and Washington – have again filed a Petition for Review in the 9th Circuit U.S. Court of Appeals.

California and New York Direct Actions

Following up on its earlier announcement, the California Department of Pesticide Regulation (“CDPR”) on August 14, 2019 issued cancellation notices to all California chlorpyrifos registrants. CDPR expressly states that its decision is based upon data from five animal studies. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.  On the same day CDPR also appointed an Alternatives to Chlorpyrifos Workgroup to address the ramifications of the withdrawal of chlorpyrifos from the market.

In New York, the legislature has passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021.

The Legislature has yet to send the passed bill to the Governor. Once the bill is transmitted to the Governor, the bill must be signed within thirty days, or it will automatically lapse in a so-called “pocket veto.” While the New York Farm Bureau is on record opposing the legislation, the Governor has given no indication of whether he will sign the bill. If he does so, opponents would likely have no recourse. Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That authority leaves opponents with little ground upon which to mount any challenge to a legislative action.

 

U.S. Environmental Protection Agency Determines that California Proposition 65 Cancer Warnings on Glyphosate (“Roundup®)” Labels Are Misleading; Orders Their Removal

On August 7, 2019, the U.S. Environmental Protection Agency (“EPA”) announced that it had determined that cancer warnings placed on glyphosate (“Roundup®)” labels in compliance with California’s Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65, are misleading, since EPA does not recognize the data used to determine that glyphosate is a potential carcinogen. In a letter to glyphosate registrants, EPA stated that the presence of such a misleading statement on a pesticide label renders the product misbranded, and has ordered registrants to file proposed amended labels removing the Proposition 65 statement.

The determination that glyphosate is a potential carcinogen was made by the International Agency for Research on Cancer (“IARC”), a unit of the World Health Organization. That determination in turn triggered an automatic classification as a carcinogen under Proposition 65, thereby triggering the obligation to place a cancer warning on glyphosate labels. EPA has disagreed with the IARC classification since it issuance. It issued its revised Evaluation of Carcinogenic Potential on December 17, 2017, and in April 2018, issued its final determination that glyphosate does not pose a threat of cancer.

Industry brought a successful challenge to the automatic listing, and secured a preliminary injunction preventing California from enforcing the label notice requirement.  See National Association of Wheat Growers v. Zeise,309 F. Supp. 3d 842 (EDCA February 26, 2018).  Notwithstanding the lack of enforcement, a number of labels already bore the Proposition 65 notice, which, given the nature of pesticide label regulation, cannot simply be removed.

It remains undetermined how the label amendment process will play out. The EPA letter simply requested that a proposed amended label be submitted, without specifying whether a notification pursuant to EPA Pesticide Registration Notice 98-10 will suffice, or whether a formal amendment is required. Either way this process is bound to prove cumbersome for affected glyphosate registrants.

 

 

Challenges to Chlorpyrifos Grow

             In the ongoing saga of the organophosphate insecticide chlorpyrifos, its registration is facing multiple new challenges on a variety of fronts. On the Federal level, attention is focused on the years-long pending Petition to Cancel filed with the U. S. Environmental Protection Agency (“EPA”) by the Natural Resource Defense Council (“NRDC”) and the Pesticide Action Network of North America (“PANNA”). On the state level, the California Department of Pesticide Regulation (“CDPR”) has announced its intention to cancel all registrations of chlorpyrifos, and the state of New York appears headed to enacting a legislative ban on its registration in New York.

Petition to Cancel EPA Registrations

            The Petition to Cancel was filed in 2007.  Its history and related litigation is recounted in the prior blog entry EPA Obtains Stay of Execution for Chlorpyrifos from 9thCircuit Court of Appeals. On 2017 EPA had announced that, contrary to staff recommendation to cancel the registrations of chlorpyrifos, it was denying the Petition. See 82 Fed. Reg. 16581 (April 5, 2017).  EPA announced that more data was required to make a decision and therefore a final determination on the safety of chlorpyrifos the review would not be completed until 2022.

            Petitioners, joined by five states and the District of Columbia, sought to have the 9thCircuit Court of Appeals compel EPA to grant the Petition and cancel the registration. Initially a three-judge panel of the 9thCircuit ordered EPA to cancel the registrations and tolerances for chlorpyrifos. See League of United Latin American Citizens et al v. Wheeler, 899 F. 3d 814 (9thCir.). EPA then sought rehearing by the full 9thCircuit. Following argument before the full panel, the Court on April 19, 2019 revoked the prior opinion and issued a Writ of Mandamus ordering EPA to respond to the Petition within 90 days, making the deadline approximately July 19.

           Given that EPA determined in its Revised Human Health Hazard Assessment and Drinking Water Exposure Assessment for Chlorpyrifos [November 2016] to revoke all food residue tolerances for chlorpyrifos, EPA will face an uphill challenge if it wishes to maintain the chlorpyrifos registrations. It is certain that anything short of a full cancellation will bring this matter back before the 9thCircuit.

California and New York Actions

            California and New York have determined that they will not await the outcome of EPA determination on the Petition and through different channels are both moving to terminate chlorpyrifos in their respective states. 

           In California, CDPR announced on May 8, 2019 that it intends to initiate cancellation proceedings for all chlorpyrifos registrations. It remains to be seen whether registrants or agricultural interests challenge the proposed cancellations.

           In New York, which is one of the intervenor states in the LULAC matter, as of April 30, 2019, both houses of the legislature have passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021. While the New York Farm Bureau is on record opposing the legislation, the governor has given no indication of whether he will sign the bill. If he does so, opponents would likely have no recourse. Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That authority leaves opponents with little ground upon which to mount any challenge.

May 10, 2019

 

Renewed Pesticide Registration Improvement Extension Act Signed Into Law

 On March 8, 2019 the President signed into law S. 438, the Pesticide Registration Improvement Extension Act of 2018. Thus the PRIA fee for service program, which had lapsed as of February 19, 2019, is back in force. Presumably anyone who submitted an application since the lapse can if they wish withdraw and refile the application. If one does so, by paying the PRIA fee they would have guaranteed decision date for their action. More details are expected from EPA as the new law is implemented.

 

 

EPA Obtains Stay of Execution for Chlorpyrifos from 9th Circuit Court of Appeals

 

In a rare move, on February 6, 2019, the U.S. Court of Appeals for the 9thCircuit agreed to an en bancrehearing of its decision in League of United Latin American Citizens (“LULAC”) v. Wheeler, 899 F. 3d 814 (9th Cir. 2018). That decision had ordered EPA to cancel all registrations of chlorpyrifos and revoke all chlorpyrifos domestic tolerances.

The original decision in LULACwas issued on August 9, 2018. It came some eleven years after Pesticide Action North America (“PANNA”) and the Natural Resources Defense Council filed a Petition with EPA seeking the revocation of chlorpyrifos tolerances. Since tolerances are required for the food use of pesticides, tolerance revocation would eliminate all domestic agricultural uses.  Tolerance revocation was the approach used by EPA when it sought to eliminate all food uses of carbofuran. See National Corn Growers Ass’n v. EPA, 613 F.3d 1131 (D.C. Cir. 2010).

By 2014, having received only partial responses, the Petitioners filed suit in the 9thCircuit seeking to compel a response to the Petition. That action was dismissed based upon EPA’s commitment to issue a decision by February 2014.  When a decision was not issued Petitioners again filed suit in the 9thCircuit, and were successful in having EPA ordered to issue a decision by October 2015. See In re PANNA, 798 F.3d 809 (9thCir. 2015). Because of this order, EPA proposed to revoke the chlorpyrifos tolerances. See 80 Fed. Reg. 69,080 (Nov. 6, 2015).

However, EPA did not proceed to a final action, as a result of which the 9thCircuit issued another Order requiring EPA to take final action by December 30, 2016. See In re PANNA, 808 F.3d 402 (9thCir. 2015).  Prior to taking final action on the Petition, EPA issued a revised risk assessment. See 81 Fed. Reg. 81,049 (Nov. 17, 2016). It found that the chlorpyrifos tolerances allowed aggregate exposures to chlorpyrifos which exceeded the safety standards of the Food Quality Protection Act, and thus should be revoked.

However, days before the Court-imposed deadline, EPA announced that it was denying the Petition in full. EPA stated that it found that more data was necessary to make a final decision on chlorpyrifos, and that it would complete its review of chlorpyrifos by the registration review deadline of October 1, 2022.  See 82 Fed. Reg. 16,581 (April 5, 2017).  That announcement prompted Petitioners to renew their litigation, resulting in the August 9, 2018 decision ordering the revocation of tolerances and the cancellation of registrations.

Much of the attention in the litigation has been focused on procedural issues unrelated to the actual science surrounding chlorpyrifos. EPA expended significant effort seeking to have the Court find that it did not have jurisdiction to hear the case, and there was a dissent to the August 9, 2018 decision agreeing with EPA’s position. Since EPA acts under the authority of the Food Drug and Cosmetic Act (“FFDCA”) with respect to tolerances, reviewability is determined under that statute. EPA argues that under the FFDCA the matter is not ripe for judicial review until EPA responds to comments to the April 5, 2017 publication. Plaintiffs argue that the response to comments is not jurisdictional and the case should be allowed to proceed, especially since EPA has stated that they do not intend to respond further until the final registration review position is issued, likely in 2022.

EPA was so focused on the jurisdictional issue that it offered no substantive defense on the risks of chlorpyrifos.  Of course any such defense would be hamstrung by the prior public positions supporting the tolerance revocation.  It remains to be seen whether EPA offers any substantive defense in the rehearing.

It is worth stressing again how rare a grant of rehearing en bancis. The Federal Rules of Appellate Procedure set a high standard for granting rehearings, requiring that the original panel decision either directly conflict with another decision of the 9thCircuit or another Circuit Court, or that the issues presented are of “exceptional significance.” Since there does not appear to be another Circuit decision directly at odds, by implication a majority of the active judges in the Circuit must have agreed that the FFDCA and FIFRA issues presented by this case are of such significance.

Another interesting aspect of this litigation is that the author of the LULAC was U.S. District Court Judge New Rakoff from the Southern District of New York, sitting by designation.  Judge Rakoff will not part of the en banc panel, which could shift the balance in the case. Given the time required for briefing, scheduling of argument and deliberation, it is likely that a decision will not be forthcoming until the latter half of 2019.