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, Jason E. Johnston, M.S., and James V. Aidala
On May 25, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update). 82 Fed. Reg. 24113. The ecological risk assessments are:
EPA states that public comments “could address, among other things, the Agency’s risk assessment methodology and assumptions applied to its draft risk assessments, such as its methodology for estimating colony-level risk to bees from exposure to bee bread.” Comments on the three ecological risk assessments are due by July 24, 2017.
The main focus of the Update document is EPA’s efforts to harmonize the risk assessment and management of the four neonicotinoids during registration review. EPA has identified additional pollinator exposure data and pollinator toxicity data needs; registrants have committed to producing the needed data, and most of the data will be submitted in 2017. EPA plans to produce final pollinator risk assessments for both agricultural and non-agricultural uses in 2018. Release of non-pollinator risk assessments (i.e., aquatic organisms, terrestrial mammals, and birds) is planned for 2017. Human health risk assessments are also scheduled to be issued in 2017. EPA has stated that mitigating risk from the uses of all neonicotinoids may be considered for all four compounds at the same time to ensure consistent risk management and to prevent unnecessary shifts in usage between the compounds without a reduction in risk. EPA intends to release final pollinator assessments and proposed interim decisions for registration review for all four neonicotinoids in 2018.
From the EPA website, the following general statement summarizes what EPA has found so far:
- The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed: most approved uses do not pose significant risks to bee colonies. However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.
To some degree, it is reassuring that widespread adoption of the neonicotinoid products appears not to be an overwhelming or altogether unanticipated risk to pollinators. For insecticides, that foliar spray applications could be harmful is not good news, as any direct contact of an insect (bees) and insecticides usually is not good for the health of the insect.
Another point some may find reassuring is that EPA has not found seed treatment with neonicotinoid products to be of significant risk. This is ironic to some degree, since one of the fundamental assumptions not long ago among many beekeepers was that the seed treatment products were a singular and significant cause of the increase in colony decline and loss.
EPA’s description of the registration review status of these products also indicates that a great volume of additional data concerning possible pollinator risks is due to arrive over the next six to 18 months. Obviously, the results of these additional studies will fundamentally inform the EPA risk assessment conclusions. At the same time, one legacy of the Obama Administration in this space, the development of state Manage Pollinator Protection Plans (MP3), also will be impacted by what EPA discovers from this volume of soon-to-arrive data.
Until then, and until the new political leadership of the agency indicates any direction on pollinator issues, it is unclear whether the pollinator issue will remain one of the priority issues for program attention, or be folded into the general timeline and normal course or registration review over the next few years.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, 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. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.
The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”
- How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
- What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
- Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
- Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
- Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action. This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.
This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos. Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.
The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer. The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.
EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.
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 and Timothy D. Backstrom
On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.” This SAP was convened to advise EPA regarding the evaluation of biomonitoring chlorpyrifos data from epidemiology studies conducted by the Columbia Center for Children’s Environmental Health (CCCEH).
The minutes indicate that the SAP has significant concerns with EPA’s proposal to use the biomonitoring chlorpyrifos data from the CCCEH epidemiology studies to establish a point of departure (PoD) for chlorpyrifos risk assessment. The minutes state: “Because many uncertainties cannot be clarified, the majority of the Panel does not have confidence that the Columbia Center for Children’s Environmental Health (CCCEH) cord blood data on chlorpyrifos concentrations can accurately be used in quantitative risk assessment to determine a Point of Departure (PoD).” A major source of uncertainty cited by the FIFRA SAP is “the lack of verification and replication of the analytical chemistry results that reported very low levels of chlorpyrifos (pg/g),” because EPA had to impute a finite quantitative value to “a large fraction of cord blood samples included in the analyses presented with levels below [level of detection (LOD)].” Moreover, some SAP members “thought the quality of the CCCEH data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced.”
The SAP also, however, stated that “both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell (RBC) acetylcholinesterase (AChE) inhibition (i.e., toxicity at lower doses).” Nevertheless, it agreed with EPA that “applying additional safety factors to the AChE PoDs to account for a possible noncholinergic mode of action (MOA) would be problematic because of challenges in justifying any particular value for such an adjustment.”
Of note, the SAP concluded that it would be appropriate to use a “10X intra-species extrapolation factor” in any analysis based on the cord blood data. It also identified other sources of uncertainty that should be considered in such an analysis, including “the inability of single measures of chlorpyrifos concentration in blood to provide information regarding source, frequency, duration and magnitude of exposure, and how these exposures are linked to specific outcomes measured in the CCCEH study participants.” Although EPA suggested in a Status Report filed in the chlorpyrifos litigation pending in the Ninth Circuit Court of Appeals on June 29, 2016, that the FIFRA SAP might recommend a “hybrid approach” that EPA could use in lieu of a PoD based on AChE inhibition, thereby altering the prior EPA analysis for chlorpyrifos, the SAP minutes do not include a recommendation for such a hybrid methodology.
Given the concerns expressed by the SAP regarding EPA’s proposal to derive a PoD from cord blood biomonitoring data collected in the CCCEH epidemiology studies, it may be unlikely that EPA will further pursue this specific approach. It is less clear whether EPA will be inclined to propose any further adjustments to its existing risk assessment for chlorpyrifos, which utilizes a PoD based on animal AChE data, along with intra-species and inter-species uncertainty factors and an additional Food Quality Protection Act (FQPA) 10X factor. EPA’s decision to retain the special FQPA factor in its risk assessment for chlorpyrifos will remain controversial, because it is based on an assessment of the value and significance of several epidemiology studies for chlorpyrifos that many in the pesticide industry strongly dispute. The discussion in the minutes of the uncertainties resulting from the refusal of the CCCEH investigators to provide underlying raw data may provide further support for arguments by industry that EPA should not predicate risk assessments on the epidemiology studies for chlorpyrifos before obtaining and reviewing these data.
More information on the FIFRA SAP and its surrounding legal issues is available in our blog item EPA Requests Six Month Extension of Deadline for Decision on Chlorpyrifos Tolerance Revocation, and more generally on our blog with keyword chlorpyrifos.
By Lisa M. Campbell and Timothy D. Backstrom
On March 28, 2016, a three-judge panel in the U.S. Court of Appeals for the Ninth Circuit, Case Nos. 15-71207, et al. (consolidated) issued an order denying the Petitioners’ March 10, 2016, motion asking the court to adjudicate their challenges to the Environmental Protection Agency’s (EPA) registration of the pesticide Enlist Duo during remand of the registration decision to EPA, as well as their alternative request that the court stay issuance of its mandate and retain jurisdiction pursuant to the original petition for review. The brief three-sentence order did not offer any explanation as to why the court denied the relief requested by the Petitioners.
The Petitioners’ March 10, 2016, motion stated that it is “appropriate to adjudicate those arguments now, because Enlist Duo remains on the market during the limited remand, causing petitioners continued harm.” In support of their motion, Petitioners argued that the purpose of the remand was to address the “narrow question” of “synergistic effects of Enlist Duo’s two main ingredients on non-target plants,” and that an ultimate decision by EPA on this narrow issue “may have no bearing on the arguments petitioners have already briefed in this Court.” Petitioners also argued that the registrant and intervenor Dow AgroSciences LLC (DowAgro) has “reneged on its promise to the Court not to sell Enlist Duo” during the remand.
EPA and DowAgro both filed responses on March 21, 2016, opposing the Petitioners’ motion. EPA’s response to the motion stated that the court’s order remanding the matter to EPA was general in scope, and “EPA may properly choose to revisit the issues raised in Petitioners’ briefs while it also considers the new information provided by Dow regarding the synergistic effects of Enlist Duo’s two active ingredients.” Thus, if the court were to consider the Petitioners’ claims during remand, “the Court would be advising EPA as to the outcome of its remand work, which is contrary to the Court’s function.” EPA also opposed the request to stay the mandate and retain jurisdiction “because Petitioners will have ample opportunity to challenge any new agency action that EPA issues after concluding its remand work.”
DowAgro’s response stated that “[t]his Court’s order did not limit the scope of the remand, so the agency is free to alter, amend, or supersede the existing registration.” DowAgro also argued that adjudicating petitioners’ claims during remand would lead to improper “piecemeal review” because “petitioners’ challenges to the original registration may be substantially altered or mooted entirely.” With respect to the Petitioners’ allegation that DowAgro “reneged” on a promise not to sell Enlist Duo during the remand, DowAgro stated that this offer was only for “the interim period while this Court was considering the remand motion, not the indefinite period the matter was on remand to the agency.”
More information regarding the court’s original remand order is available in our blog item Ninth Circuit Denies EPA Motion for Vacatur, Grants EPA Motion for Remand.
It would have been, in the view of many, surprising for the court to agree to adjudicate Petitioners’ claims concerning the registration decision for Enlist Duo during the period that decision is remanded to EPA for further action. Similarly, it is not surprising to many that the court declined to retain jurisdiction, since the remand to EPA will not operate to constrain the ability of the Petitioners to raise the same claims in the event that EPA decides to issue a new registration for Enlist Duo following remand.
It is not clear at this juncture whether EPA will be inclined to reconsider its views concerning any of the Petitioners’ claims during the remand process. Petitioners likely will, however, have another opportunity to seek review concerning their claims, assuming they participate in the administrative process during remand, and EPA does not alter its original decision in a manner that moots those claims.
By Sheryl L. Dolan, Lisa M. Campbell, and Henry M. Jacoby, M.S.
On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance actions for fiscal year (FY) 2016 that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The Pesticide Registration Improvement Act of 2003 (PRIA) established FIFRA Section 33, creating a registration fee-for-service system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA). Section 33 also created a schedule of decision review times for applications covered by the service fee system. EPA began administering the registration service fee system for covered applications received on or after March 23, 2004.
PRIA has been reauthorized twice, most recently by the Pesticide Registration Improvement Extension Act (PRIA 3) signed on September 28, 2012. PRIA 3 revised FIFRA section 33, reauthorized the service fee system through fiscal year 2017, and established fees and review times for applications received during fiscal years 2013 through 2017. The registration fees for covered pesticide registration applications received on or after October 1, 2015, increase by five percent from the fees published for fiscal year 2015 in the Federal Register notice issued September 26, 2013, Pesticides; Revised Fee Schedule for Registration Applications. The new fees became effective on October 1, 2015.
The notice retains the format of prior PRIA tables; it identifies the registration service fees and decision times and is organized according to the three Office of Pesticide Programs (OPP) registration divisions within EPA, with the additional sections for inert ingredients and other actions added as part of PRIA 3. Thereafter, the categories within main sections of the table are further organized according to the type of application being submitted, including new active ingredients, new uses, new products, and registration amendments There are 189 categories of activities spread across the three OPP divisions: Registration Division (63 categories), Antimicrobial Division (39 categories), and Biopesticides and Pollution Prevention Division (69 categories), plus ten inert ingredient and eight miscellaneous categories. Each has its own decision review time and service fee for FY 2016-2017. The scale of the fees differs between the three registration divisions. We note that not all submissions are subject to PRIA 3; generally speaking, any submission requiring data review will be subject to PRIA 3.
The notice also provides information on how to pay fees, how to submit applications, and the addresses for applications.
More information on the registration fees is available on EPA’s webpage FY 2016/17 Fee Schedule for Registration Applications.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated). Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.
NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo. The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case. The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D. In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.
The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest. In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008). In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief. Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.
While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved. As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product. Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.
By Timothy D. Backstrom
On June 12, 2015, Federal District Judge Maxine Chesney issued a decision in Ellis v. Housenger (N.D. Cal.) allowing the plaintiffs to utilize expert declarations and exhibits that were not included in the certified administrative record to support their contentions that the U.S. Environmental Protection Agency (EPA) improperly failed to consult the Fish and Wildlife Service (FWS) under Section 7 of the Endangered Species Act (ESA). The plaintiffs in the Ellis case are individual beekeepers and non-governmental organizations, and two out of the six claims in their complaint allege a failure by EPA to consult under the ESA before registering or adding new registered uses for products containing two neonicotinoid pesticides, clothianidin and thiamethoxam. Judge Chesney’s order was issued in response to separate motions by EPA and by industry intervenors Bayer Crop Science, Syngenta Crop Protection, and Croplife America to preclude the plaintiffs from utilizing extra record material to support their ESA claims.
Although EPA and the intervenors argued that the Court’s review of the ESA claims should be confined to the administrative record based on the Administrative Procedure Act (APA), Judge Chesney determined that extra record material may be used to support an allegation that an administrative agency failed to consult with the FWS as required by ESA Section 7. The Judge based this holding on two cases decided in the Ninth Circuit, Washington Toxics Coalition v. EPA and Western Watersheds Project v. Kraayenbrink, which each held that extra record material may be properly considered in determining whether an agency improperly failed to consult under ESA Section 7. The Judge rejected the contention by EPA and the intervenors that these two decisions were supplanted by Karup Tribe v. U.S. Forest Service, concluding that the “arbitrary and capricious” standard of review established by the APA is utilized to review the ESA claims, but the scope of review for these claims is not constrained by the APA.
The effect of this decision will be to allow the plaintiffs to present expert opinion and evidence concerning the claimed adverse effects of the two neonicotinoid pesticides on endangered and threatened species, including but not limited to pollinator species, that was not expressly considered by EPA when it decided to register these pesticides. The plaintiffs will argue that such extra record material establishes that there was a sufficient basis to conclude that these pesticides “may affect” endangered or threatened species for EPA’s failure to consult FWS under the ESA to be arbitrary and capricious. This preliminary ruling could materially affect review of the ESA counts because there is a substantial division of expert scientific opinion concerning the alleged adverse effects of neonicotinoid pesticides, and the Court may conclude that EPA did not afford adequate weight to some of this opinion.
By Lisa M. Campbell and Lisa R. Burchi
On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces. In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.”
The interim guidance is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the antimicrobial data requirements (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia. The settlement agreement is discussed here.
In the settlement, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses.
The interim guidance states with regard to the 200 ppb standard:
No later than September 2, 2017, the Agency will propose a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will be to clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity. The Agency is providing this interim guidance to registrants that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on only a single commodity.
EPA states that this interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy. In general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data. If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results.
Also in the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period. The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses. The letter states the following regarding its development of the USI guidance:
The Agency is developing a guidance document called the Antimicrobial Pesticide Use Site Index (USI) that will serve as a compilation of existing use sites and will identify how each use site fits within the twelve use patterns established in 158W. The guidance document will serve to assist prospective registrants with the application requirements by making it easier for them to identify which data are necessary to register their product(s).
EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:
- EPA may find it necessary, “in the context of, but not limited to, the requirements in 158W,” to call in data as each active ingredient is evaluated under the Registration Review program. EPA does not intend to conduct this generic evaluation for new products or applications to amend existing products that are covered in Pesticide Registration Improvement Extension Act (PRIA3) fee category Table 9 -- Antimicrobial Division -- New Products and Amendments.
- During early implementation of the 158W requirements, EPA recognizes that not all new applications will have all the newly-required data. EPA may thus find it appropriate to issue Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) conditional registrations and set a deadline for the submission of the required data.
- Any application submitted after July 8, 2013 (the effective date of the 158W requirements) must contain the required data or an adequate justification for any data requirements not submitted. On the issue of timing, applicants should explain why any data are not yet submitted and when the data can be submitted. Failure to submit required data or provide an adequate justification will result in EPA rejecting the application as incomplete under the 45/90 day preliminary technical screen under the Pesticide Registration Improvement Act (PRIA).
The settlement agreement and additional documents are available at http://www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w#interim and www.regulations.gov in docket EPA-HQ-OPP-2008-0110. More information on antimicrobial policies and guidance is available here.