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.

 

EPA Attempt to Delay Certified Pesticide Applicator Rule Overturned by Court

In an action brought by a major Latino farmworker union,  the U.S. District Court for  the Northern District of California overturned efforts by EPA to delay the implementation of the Certified Pesticide Applicator rule. In January 2017, the EPA determined to revise the rule and in the interim sought to postpone its effective date from March 2017 to  March 2020. The judge ruled that the delay would cause the plaintiffs to suffer injury and that EPA failed to comply with the Administrative Procedures Act. The Court annulled the rulemakings postponing the rule and reinstated the original timeline for implementation.

This decision represents a major victory for agricultural and pesticide workers. Of these revisions, the most significant entail strengthening regulations on certified applicators.  Certification is required for the use of restricted use pesticides (RUPs). RUPs are known to be highly toxic and responsible for acute toxicity issues in persons that apply and handle them. The rule requires states to update their certification plans in accordance with the updated regulations, and to combat poisoning issues and promote worker safety, establishes for the first time a nationwide minimum age for certifying pesticide applicators. The rule mandates that people be at least 18 years old to become certified, with a provision that allows family members at least 16 years old to become certified, effective only on the certified applicator’s family farm.