By Timothy D. Backstrom and Lisa M. Campbell
On September 25, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents U.S. Environmental Protection Agency (EPA) and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke all tolerances and cancel all registrations for chlorpyrifos, and that specifically directed EPA to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days. More information regarding the August 9 decision is available in our blog item “Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos.”
EPA’s petition for rehearing sets forth three discrete procedural arguments as to why rehearing should be granted. The first argument is that the panel erred because “an initial decision denying an administrative petition under 21 U.S.C. § 346a(d)(4)(A)(iii) is simply not within the jurisdiction of this Court to review ….” EPA contends that the decision to grant judicial review of the initial EPA order, without waiting for EPA to respond to objections or to issue a final order, conflicts with the applicable precedent in both the Ninth Circuit and the U.S. Court of Appeals for the Second Circuit (Second Circuit).
EPA’s second argument is that, even if the initial EPA order is deemed to be reviewable, the panel’s decision directing EPA to take specific actions on remand “exceeded the remedial authority granted the courts by Congress” and conflicts with applicable Supreme Court precedent. EPA identifies some other actions that EPA could hypothetically have decided to take on remand, including denying the administrative petition based on a finding that the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standard is met, reducing the affected tolerances, or revoking only certain tolerances. EPA argues that the court was not empowered to direct EPA to take specific actions, but should have instead remanded the matter to EPA “for further consideration in light of the panel’s holding that EPA may not ‘decline to revoke chlorpyrifos tolerances [without] mak[ing] a finding of reasonable certainty that the tolerances were safe.’”
EPA’s third argument is that, in the event a broader rehearing is not granted, a rehearing by the panel should nonetheless be convened to modify the relief ordered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA argues that revocation of the chlorpyrifos tolerances would not lead automatically to cancellation of all chlorpyrifos registrations, because there are also some non-food uses for chlorpyrifos. EPA states that “FIFRA incorporates the safety standard of the FFDCA only with respect to food-use pesticides …” (emphasis in original). EPA also notes that EPA lacks authority to comply with the court’s order to cancel all chlorpyrifos registrations within 60 days, because EPA must follow the statutory procedure for cancellation under FIFRA Section 6(b), which requires EPA to forward a proposed cancellation first to the U.S. Department of Agriculture (USDA) and the FIFRA Scientific Advisory Panel (SAP), and to afford the affected registrants and other adversely affected persons an opportunity to request an adjudicatory hearing to contest the proposed cancellation. EPA states that the panel should provide at least a limited rehearing, because it granted relief without the benefit of any prior briefing on remedy in which these significant problems would have been identified.
Although parties to appellate litigation often seek rehearing or rehearing en banc, federal agencies represented by the U.S. Department of Justice (DOJ) are considerably more selective about the circumstances in which they will file a petition for rehearing. There are some compelling arguments supported by precedent that judicial review is not available under the FFDCA for the type of initial order concerning which the petitioners in this case sought review. Moreover, EPA has identified some practical factors which make it literally impossible for EPA both to adhere to mandatory statutory procedures under FIFRA and to comply with the terms of the court’s order. For this reason, even if a broader rehearing is not granted concerning the jurisdictional question or the authority of the court to order EPA to take specific actions, a narrower rehearing before the appellate panel may be ordered, which would allow the parties an opportunity for further briefing on remedy and permit the court to modify its order.
More information on chlorpyrifos issues, including further proceedings in this case, is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.” A separate dissent stated that the court should have dismissed the case for lack of jurisdiction. Please see our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017.
EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because Section 408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1).The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.”In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order.
After concluding that the objections process is not jurisdictional in character, the majority next considered whether the petitioners should nonetheless be required to exhaust their administrative remedies by waiting until EPA responds to their objections before obtaining judicial review.Although FFDCA Section 408(g)(2)(C) requires EPA to rule on the objections “as soon as practicable,” EPA had taken no action for 13 months after the objections were filed.The majority concluded that the exhaustion requirement should be waived “in light of the strong individual interests against requiring exhaustion and weak institutional interests in favor of it.”
EPA did not specifically address the substantive merits of the 2017 order in its brief, and the majority found that EPA has consequently “forfeited any merits-based argument.”The 2017 order was issued in the context of an administrative record in which EPA has repeatedly determined that the FFDCA standard for maintenance of chlorpyrifos tolerances (“a reasonable certainty that no harm will result from aggregate exposure to the pesticide”) could not be met because of the risk of neurodevelopmental effects. The standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) incorporates this same FFDCA standard. Although the 2017 order stated that “the science addressing neurodevelopmental effects is unresolved,” it did nothing to alter these prior EPA determinations. The majority noted that EPA’s assertion that “significant uncertainty” remains regarding the health effects of chlorpyrifos being directly at odds with the “reasonably certainty” standard and “therefore mandates revoking the tolerance under [FFDCA Section 408(b)(2)(A)(i)].” The majority concluded that the possibility that future evidence may contradict EPA’s current determinations cannot justify continued inaction, and that the failure of EPA to proceed with the revocation of the tolerances and the cancellation of the registrations for chlorpyrifos “has now placed the agency in direct contravention of the FFDCA and FIFRA.”
The court’s direct instruction requiring EPA to proceed promptly with revocation of all tolerances and cancellations of all registrations for chlorpyrifos represents an unusually aggressive judicial intervention in the administrative process.Nevertheless, this outcome must be viewed in the context of an eleven year history beginning with an administrative petition that requested the same relief, followed by a writ of mandamus in 2015 from the same court requiring EPA to make a prompt decision on the petition.Although substantial controversy remains concerning the correct interpretation of epidemiology studies with chlorpyrifos, it appears that the court believes that EPA has not taken any action that would support a change in EPA’s prior conclusion that these studies constitute evidence of potential neurodevelopmental effects in children at chlorpyrifos exposure levels below the threshold for acetylcholinesterase (AChE) inhibition. Had EPA’s 2017 denial of the administrative petition been accompanied by an amended risk assessment for chlorpyrifos which articulated a changed conclusion, the court may have been less likely to substitute its judgment for that of EPA.The court seemed to find that because the scientific assessments in the current administrative record could not support the “reasonable certainty” standard in the FFDCA, the conclusion it reached on the merits was unavoidable.
Please see our blog item “Oral Argument Held in Case Challenging EPA’s Denial of Petition to Revoke Chlorpyrifos Tolerances” for information on the oral argument that took place on July 9, 2018, and the briefing in this case. Further information on the case proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On December 20, 2017, the U.S. Court of Appeals for the Ninth Circuit issued an order in LULAC v. Pruitt, Case No. 17-71636, a case challenging an order denying administrative petitions to revoke the tolerances and cancel the registrations for chlorpyrifos. The court’s order includes actions concerning two pending motions. The court has denied a motion by the U.S. Environmental Protection Agency (EPA) and Administrator Pruitt (Respondents) to dismiss the case for lack of jurisdiction while granting a motion by League of United Latin American Citizens (LULAC), et al. (Petitioners) to expedite briefing and hearing in the case. More information on these two motions is available in our blog item “NGOs and Farmworkers File Motion for Expedited Briefing and Hearing in Chlorpyrifos Litigation.”
In support of their August 21, 2017, motion to dismiss the case for lack of jurisdiction, Respondents argued that the Federal Food, Drug, and Cosmetic Act (FFDCA) requires the Petitioners to exhaust their administrative remedies by submitting formal objections to the order denying their request to revoke the tolerances for chlorpyrifos and then waiting for EPA to issue a final order before they may seek judicial review. The Petitioners argued in response that requiring exhaustion in this instance would be “futile,” and that the court should also consider reviewing the EPA order under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), because EPA has declined to cancel the registrations for chlorpyrifos. In response, Respondents argued that Petitioners have not shown that requiring exhaustion of administrative remedies would be futile, and that 21 U.S.C. § 346a(h)(5) explicitly prohibits judicial review of any order concerning pesticide tolerances under any other statute, including FIFRA.
After the motion to dismiss was fully briefed, the court summarily denied it, but also characterized that denial as “without prejudice to renewing the arguments in the answering brief.” The court also denied a motion by the Petitioners for oral argument concerning the pending motion to dismiss. These two actions indicate that the court has decided to defer argument and resolution of the jurisdictional issues presented by the motion to dismiss until briefing and argument on the merits.
The court also granted an October 13, 2017, motion by the Petitioners to expedite briefing and hearing in the case. Petitioners submitted this motion to expedite because they contend that the refusal of EPA to revoke the tolerances and cancel the registrations for chlorpyrifos is causing ongoing harm even though EPA “did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.” The court set the following expedited briefing schedule: Petitioners’ opening brief is due January 23, 2018; Intervenors’ brief(s) are due February 6, 2018; Respondents’ answering brief is due March 8, 2018; Petitioners’ optional reply brief is due 28 days after service of Respondents’ brief; and Intervenors’ optional reply brief(s) are due 42 days after service of Respondents’ brief. The court also directed the Clerk to “calendar this case [for argument] as soon as possible upon completion of briefing.”
The current actions of the court should be viewed in the context of the prior decision by this same court to issue a writ of mandamus that required EPA to take action on pending petitions to cancel the registrations and revoke the tolerances for chlorpyrifos after what Petitioners claimed was a quite protracted administrative delay, and the subsequent decision by EPA under Administrator Pruitt to defer final action on chlorpyrifos, after the prior Administration had proposed to take the actions sought by the Petitioners. By granting the motion to expedite, and also by deferring the ultimate disposition of the jurisdictional issues raised by EPA, the court appears to have given the Petitioners a prompt and full opportunity to explain why judicial intervention at this stage of the administrative process is warranted. Nevertheless, because the jurisdictional arguments made by EPA are supported by substantial precedent, it could prove difficult for the Petitioners ultimately to overcome these arguments.
More information on the chlorpyrifos litigation and related matters is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On October 13, 2017, Petitioners League of United Latin American Citizens (LULAC), et al. filed a motion to expedite briefing and hearing in League of United Latin American Citizens v. Pruitt, Case No. 17-71636 (9th Cir. June 5, 2017). In their motion, Petitioners request that the court “expedite proceedings because of the harm being caused by [U.S. Environmental Protection Agency (EPA)] Administrator Pruitt leaving chlorpyrifos tolerances in effect when he did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.”
Petitioners state there is good cause for expedition “because children continue to be exposed to chlorpyrifos in their food, drinking water, and the air around their homes, schools, and playfields, putting them at risk of such brain impairments as lower IQ, attention deficit disorders, and developmental delays,” and “Ninth Circuit Rule 27-12 provides that ‘motions to expedite briefing and hearing may be filed and will be granted upon a showing of good cause,’” including ‘“situations in which … in the absence of expedited treatment, irreparable harm may occur.’” Pursuant to Ninth Circuit Rule 27-12, Petitioners determined the position of EPA counsel on the motion, who stated that, “EPA opposes the motion to expedite as premature under Circuit Rule 27-11(b).”
The Petitioners’ motion to expedite briefing was submitted despite the pendency of an unresolved motion to dismiss submitted by Respondents Administrator Pruitt and EPA on August 21, 2017. In that motion, EPA argued that the court lacks jurisdiction to review the March 29, 2017, order denying the petition by Pesticide Action Network North America (PANNA) and Natural Resources Defense Council (NRDC) to revoke all Federal Food, Drug, and Cosmetic Act (FFDCA) tolerances for chlorpyrifos, until after the Petitioners have exhausted their administrative remedies by filing objections to the denial, and EPA has issued a final order ruling on such objections. In its motion to dismiss, EPA noted that the Ninth Circuit denied a motion by PANNA and NRDC for further mandamus relief in In re PANNA on July 18, 2017, stating that “one valid agency response to a petition challenging a pesticide’s tolerances is to ‘issue an order denying the petition,’” and ‘“now that EPA has issued its denial, substantive objections must first be made through the administrative process mandated by’ the FFDCA.”
On September 27, 2017, Petitioners filed their opposition to the motion to dismiss. Petitioners argued that exhaustion of administrative remedies by filing objections under the FFDCA is not an absolute jurisdictional prerequisite to judicial review, and that the court can proceed with review under the “futility doctrine” because EPA’s refusal to revoke the tolerances for chlorpyrifos constitutes a “flagrant violation of a statutory prohibition.” Petitioners also argued that even if FFDCA exhaustion is required, EPA has also denied the petition by PANNA and NRDC to cancel the registrations of chlorpyrifos, and that additional denial constitutes a final order that is subject to immediate review under FIFRA Section 16(b) because the notice and comment process concerning the petition was a “public hearing” under the applicable precedent.
The new motion by Petitioners LULAC, et al. to expedite briefing on the challenge to EPA’s denial of the PANNA and NRDC petition reflects the view of the Petitioners that this matter is urgent because continued use of chlorpyrifos jeopardizes the health of children, but this motion is unlikely to be resolved before the court rules on EPA’s pending motion to dismiss. EPA has stated that it will oppose the Petitioners’ motion to expedite briefing as premature. Moreover, EPA has not yet replied to the arguments made by the Petitioners in their opposition to the pending dismissal motion.
To prevail on their argument that exhausting the administrative process prescribed by the FFDCA will be “futile,” the Petitioners likely will have to persuade the Court that these FFDCA procedures are not jurisdictional prerequisites to judicial review, and that there is little likelihood that EPA will change its mind in response to their objections. With respect to the argument that EPA’s denial of the petition to cancel the registrations for chlorpyrifos is final agency action subject to immediate review under FIFRA Section 16(b), EPA will likely contend that this argument is contravened by 21 U.S.C. § 346a(h)(5), which states: “any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review under any other provision of law.” It could be difficult for Petitioners to defeat this jurisdictional prohibition in the FFDCA; they would presumably need to show the court that their substantive contentions concerning the hazards posed by chlorpyrifos would not be directly implicated in EPA’s final determination of whether or not to revoke the tolerances for chlorpyrifos.
This case will be carefully watched by pesticide industry observers.
More information on regulatory issues related to chlorpyrifos is available on our blog.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings. In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyifos food tolerances must be revoked.” More information on the motion is available in our blog item Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos.
In its order, the panel held that since the prior mandamus proceedings “addressed the timing, not the substance, of EPA’s response,” EPA had “complied with the panel’s previous orders by issuing a ‘final response to the petition.’” The mandamus motion thus was “premature, and its substantive objections to the EPA’s denial must first be made through the administrative process mandated by statute.”
The demand imposed by the court earlier was to make a decision, and EPA met that deadline with its denial. This is a significant win for industry, but is far from the end of this debate, which will continue in a number of different forums. More information on the proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document. These documents were signed by EPA scientists on December 29, 2016, prior to the new Administration, but were placed in the docket only last month, under the new Administration. The documents attempt to rebut the various criticisms of EPA’s assessment of the epidemiology studies for chlorpyrifos and the original FQPA safety factor determination for OP pesticides, and they reaffirm the policy embodied in the original Literature Review. Because these new documents were signed in the last days of the Obama Administration, they may be viewed by some industry stakeholders as an effort by some at EPA to “lock in” the prior policy concerning OP pesticides.
The public release of the “updated” Literature Review and response to comments must be considered in the context of the ongoing chlorpyrifos battles that have received significant public attention. During the five months between the date that these “update” documents were signed and the date that EPA placed them in the public docket, EPA Administrator Pruitt issued a decision on March 29, 2017, to deny the petition filed by the Pesticide Action Network North America (PANNA) and the National Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for chlorpyrifos products. See EPA Denies Petition to Ban Chlorpyrifos. In his denial decision, Administrator Pruitt concluded it would be appropriate for EPA to defer determining whether chlorpyrifos is likely to cause neurodevelopmental effects at exposure levels below the levels that cause acetylcholinesterase (AChE) inhibition until the completion of the registration review process for chlorpyrifos. Administrator Pruitt based his decision on the premise that “the science addressing neurodevelopmental effects remains unresolved” and that “significant uncertainty … exists regarding the potential for chlorpyrifos to cause adverse neurodevelopmental effects.”
Some industry stakeholders may argue that the decision by the EPA scientists who prepared the “updated” Literature Review which concluded that EPA should retain the 10X FQPA uncertainty factor for OP pesticides can be reconciled with Administrator Pruitt’s subsequent denial decision, because the “updated” FQPA safety factor determination does not preclude further scientific discussion concerning the potential for neurodevelopmental effects from OP pesticide exposures. On the other hand, other industry stakeholders may be concerned about the immediate adverse impact of this “updated” FQPA determination on the risk assessments prepared by EPA for OP pesticides and the measures that will be demanded by EPA to mitigate purported risks.
On April 5, 2017, PANNA and NRDC responded to Administrator Pruitt’s March 29, 2017, decision to deny their petition to revoke the tolerances and cancel the registrations for chlorpyrifos by submitting to the Ninth Circuit Court of Appeals a Motion for Further Mandamus Relief. That motion was substantially based on the premise that EPA does not “suggest that it has reconsidered its finding that chlorpyrifos is unsafe.” The briefing on the new mandamus motion was completed on May 5, 2017, several weeks before EPA disclosed the documents concerning the “updated” FQPA determination. Nevertheless, petitioners could try to argue that these documents constitute further evidence supporting their key premise that EPA has not actually revisited its prior determination that chlorpyrifos exposures are unsafe.
The legal and policy issues posed by EPA’s evaluation of the epidemiological data for chlorpyrifos and by EPA’s determination that these data create sufficient uncertainty to warrant retention of the FQPA 10X safety factor for all OP pesticides will be a continued source of controversy, and will be watched with interest by all stakeholders.
More information and updates on chlorpyrifos, the epidemiological data, and their surrounding legal issues is available on our blog item under keyword chlorpyrifos.
By Lisa M. Campbell and James V. Aidala
On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances. In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances. Petitioners state that EPA’s response to the petition (the order) is “no response at all and not what this Court ordered EPA to do,” and asks the court to “grant further mandamus relief, giving EPA 30 days to act on its findings that chlorpyrifos exposures are unsafe and to establish deadlines for the next steps in the revocation and cancellation processes for chlorpyrifos.” Specifically, Petitioners request that the court order EPA to:
- Take regulatory action within 30 days on its finding that chlorpyrifos is unsafe and “make it abundantly clear that what is required within 30 days is final regulatory action based on the neuro-developmental and other risks posed by chlorpyrifos exposures”;
- Resolve objections to its final regulatory action within 60 days, as opposed to “as soon as practicable after receiving the arguments of the parties,” because, Petitioners assert, EPA otherwise may put off their response for a long period of time;
- Require EPA to issue a notice of intent to cancel all chlorpyrifos uses within 60 days, “consistent with its risk assessments and findings that chlorpyrifos is unsafe,” as it has “found drinking water contamination from all chlorpyrifos uses, including nonfood uses, and will need to take regulatory action to end such uses in addition to stopping food uses”; and
- File six-month status reports until the tolerance revocation process and the cancellation proceedings are complete.
It is no surprise that the Petitioners who were disappointed by EPA’s denial of the petition one week ago have now continued their advocacy against the use of chlorpyrifos. As we note in our previous blog item EPA Denies Petition to Ban Chlorpyrifos, EPA articulated its reason for the denial as of this time, but this in itself did not articulate its determination that the registration and associated tolerances met the requirements of the Food Quality Protection Act (FQPA). EPA’s response to this latest legal skirmish will be of interest, as will the court’s response to it. .
More information on the proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and James V. Aidala
On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this story.
EPA’s decision denying the petition addresses each of the petition’s ten claims and the history of EPA’s review and responses to those claims. Much attention will be paid to the order’s discussion of three of the claims, which the order states all relate to the same issue: “whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below EPA’s existing regulatory standard (10% cholinesterase inhibition).” The order states that because “Congress has provided that EPA must complete registration review by October 1, 2022,” and because EPA has “concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution” on the issues concerning potential neurodevelopmental effects in children, EPA is denying the claims, given the Ninth Circuit Court of Appeals’ August 12, 2016, order that “made clear” that further extensions to the March 31, 2017, deadline for responding to the petition would not be granted. EPA states that the “science addressing neurodevelopmental effects remains unresolved,” and “further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos.”
The order will become effective as soon as it is published in the Federal Register. More information on the prior proceedings concerning this matter is available on our blog under key phrase chlorpyrifos.
This decision by EPA under the Trump Administration to deny the petition is not surprising, given the rhetoric of reducing regulatory burdens and the need to stop regulatory “overreach” by agencies like EPA which has been accused of making politically driven decisions. EPA's press release captures this, quoting Administrator Pruitt stating (in part): "By reversing the previous Administration’s steps to ban one of the most widely used pesticides in the world, we are returning to using sound science in decision-making -- rather than predetermined results.”
EPA has, however, “kicked the can down the road” to some extent on the key science issue -- whether EPA appropriately evaluated epidemiology studies which reported that exposures to the pesticide had adverse neurological impacts on infants and children -- an issue that affects not only chlorpyrifos, but the other organophosphates (OP) that EPA has concluded are subject to a Food Quality Protection Act (FQPA) 10X factor based on these studies. (See EPA’s September 15, 2015, Literature Review on Neurodevelopment Effects & FQPA Safety Factor Determination for the Organophosphate Pesticides.)
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) members who reviewed EPA’s approach, based on these studies with regard to chlorpyrifos, generally had concerns with its proposed approach. When EPA nonetheless issued its renewed call for revocation of the tolerances in November 2016, eight days after the Presidential election, it was seen by some as partly (if not fully) driven by a “political” calculus which ignored the lack of support of the FIFRA SAP.
The November 2016 proposal was based on more than the epidemiology studies which have proven controversial. At the same time, EPA’s arguments in the November notice relied on some of the earlier findings about the studies and FIFRA SAP’s review to fashion a “hybrid” approach which, not surprisingly, supported EPA’s previous conclusions.
This has led to charges of “politics over science” on all fronts, but in responding to the court deadline for a final decision by March 31, 2017, EPA has now declared it does indeed need more time to resolve the science issues, and argues that the general registration review process, with the chlorpyrifos review scheduled for 2022, gives EPA more time than what the court imposed. EPA has concluded that if a decision is needed now, the required burdens have not been met to change the current status of the pesticide. The order states:
- Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues.
EPA has determined it needs more time, however frustrating that may be, to sort out the science. As such, it is allowing chlorpyrifos use to continue, but objections to EPA’s decision are expected by the petitioners who originally pushed for the tolerance revocations. The effect on other OPs with regard to the application of the FQPA uncertainty factor is unclear, at best. The science debate will rage on, with no clear timeline or process for how the ultimate resolution of these questions will be “final.” This political and legal back-and-forth may become the new normal for the Trump Administration as it seeks to balance a more “business friendly” regulatory approach with the stringent requirements of the statutory duties of underlying authorizing legislation across all of EPA’s programs.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On August 12, 2016, a three-judge panel of the Ninth Circuit Court of Appeals issued an order denying the U.S. Environmental Protection Agency’s (EPA) request for an additional six months to decide whether to ban agricultural uses of chlorpyrifos. The court opted instead to afford EPA a three month extension, stating that “this is the final extension, and the court will not grant any further extensions."
EPA sought the six month extension on June 29, 2016, to allow time for EPA to complete two scientific analyses that may bear on EPA’s conclusions in the final rule, and to request further public comment before taking final action on a prior proposal to revoke all chlorpyrifos tolerances. The two analyses that EPA wanted to complete are: (1) a refined drinking water assessment that may allow EPA “to develop more tailored risk mitigation for some regions of the country,” and (2) an evaluation of the epidemiological data for chlorpyrifos to determine whether EPA should retain the point of departure based on acetylcholinesterase (AChE) inhibition in the proposed rule.
The court concluded that EPA’s request for a six month extension “is not justified in light of EPA’s history in this matter as well as the court’s previous extensions.” The court stated that EPA’s request was "another variation on a theme 'of partial reports, missed deadlines, and vague promises of future action' that has been repeated for the past nine years,” and that “nothing has changed that would justify EPA’s continued failure to respond to the pressing health concerns presented by chlorpyrifos."
The court ordered EPA to take final action on its proposal to revoke tolerances for chlorpyrifos by March 31, 2017. A further status report by EPA will be due in November 2016.
EPA’s updated analysis of the epidemiological data for chlorpyrifos will be a matter of considerable interest. After EPA issued a proposed rule utilizing a point of departure for chlorpyrifos based on AChE inhibition, EPA issued a blanket determination based on the epidemiological data for chlorpyrifos in which EPA decided to retain the Food Quality Protection Act (FQPA) safety factor for all organophosphate (OP) pesticides. This FQPA determination could cause EPA to conclude that the tolerances for chlorpyrifos must be revoked regardless of the outcome of the refined drinking water assessment.
EPA later proposed to use an alternative point of departure for chlorpyrifos based on biomonitoring data from one of the chlorpyrifos epidemiology studies, but the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met on April 19-21, 2016, and recommended against this new approach. In its request for an extension, EPA stated that the FIFRA SAP might recommend a “hybrid approach” to adjusting the point of departure for AChE inhibition. The FIFRA SAP meeting minutes do not appear to include such a hybrid recommendation.
In a related development, EPA has reached an agreement with the Columbia Center for Children’s Environmental Health (CCCEH) regarding the release of raw data from one of the chlorpyrifos epidemiology studies. During the FIFRA SAP meeting, concerns were raised regarding use of the CCCEH study without access to the underlying raw data. In an April 19, 2016, letter to Dr. Linda P. Fried, Dean of the Mailman School of Public Health at Columbia University, EPA requested that CCCEH provide access to the underlying data. In her response dated May 18, 2016, Dr. Fried offered to work with EPA “to determine if we can develop one or more data sets that can be properly de-identified, consistent with our obligation to protect the privacy of our research subjects, and that will also enable EPA to conduct its own analyses in order to address its transparency goals” or, in the alternative, offered to allow EPA staff to review the original data “in a secure data enclave onsite at Columbia.” In its June 27, 2016, response, EPA stated that the offer to allow EPA staff to review the underlying data at a secure site did not resolve issues concerning the transparency of EPA’s analysis. This correspondence is available in EPA Docket ID EPA-HQ-OPP-2008-0850. While EPA maintained it is “unnecessary” for CCCEH and EPA to develop redacted data sets, EPA accepted CCCEH’s offer to develop such data sets.
EPA’s request for a six month extension was filed on June 29, 2016, two days after it accepted the offer by CCCEH to develop redacted data sets for the CCCEH epidemiology study. Moreover, the FIFRA SAP meeting minutes issued on July 20, 2016, do not appear to provide the guidance that EPA had expected concerning a potential “hybrid” approach to adjusting EPA’s proposed point of departure for AChE inhibition.
Given the lesser extension granted by the court, it is questionable whether EPA will have sufficient time to review adequately the redacted underlying data sets offered by CCCEH, or even to determine whether those redacted data sets are adequate for this review, and to make any determination based on such data before EPA issues a supplementary proposal based on the refined drinking water assessment and the updated epidemiology assessment. The court has stated that it will entertain no further extension requests, so EPA must complete its work expeditiously to allow time for comment before final action is due on March 31, 2017.
By Lisa M. Campbell and Timothy D. Backstrom
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.” Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred. EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise. In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects. EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources. The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”
The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.” While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.
More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.