By James V. Aidala and Margaret R. Graham

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB).  83 Fed. Reg. 49091.  EPA states that “all nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides”  and requests that any individuals nominated have expertise in one or more of the following areas:  biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review.  The Designated Federal Officer’s to whom nominations should be provided is listed in the Federal Register notice.  Nominations are due by November 13, 2018. 

Commentary

FPQA added this SRB to the previous authorization for the SAP to recognize the expanding universe of scientific questions which often underlie issues surrounding pesticide registration.  The FQPA amendment simply adds that “60 scientists who shall be available to the SAP” without specifying any particular disciplines or skills which might be useful to assist with the deliberations and review by the SAP.  This was intended to continually allow EPA to adapt to changing or evolving scientific questions without constantly tinkering with the membership of the SAP itself.  At the same time, it allows these ad hoc members to be recognized for their contributions and to be compensated in the same manner as SAP members.  

By Lisa R. Burchi and Lisa M. Campbell

On September 25, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process that details the results from the its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use.  These short-term pesticide use approvals are called emergency exemptions.”  OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.”  OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.”

OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:

1. EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
2. OPP does not consistently communicate emergency exemption information with its stakeholders.  OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process.  OPP has not sent this letter since 2015, however.
3. There were significant deficiencies in the OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget.

The eight OIG recommendations in the report for the Assistant Administrator (AA) for the Office of Chemical Safety and Pollution Prevention’s (OCSPP) consideration, and OCSPP’s response to those recommendations, are as follows:   

Recommendation 1:  Develop and implement applicable outcome-based performance measures to demonstrate the human health and environmental effects of the EPA’s emergency exemption decisions.

• OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that development of an outcome-based performance measure for the Section 18 emergency exemption process was neither appropriate nor feasible.  No proposed corrective actions were proposed and this issue remains unresolved. 

Recommendation 2:  Determine which application review performance target for emergency exemption applications the OPP plans to meet, and make that target consistent between its Annual Performance Goal and its internal controls governing the emergency exemption process.

• OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless provided a corrective action “to avoid future confusion” and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 3:  Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 4:  Develop formal emergency exemption application review procedures that detail specific data collection, management and reporting control steps, and procedures that require specific management controls for accurately and consistently updating the OPP’s Section 18 database.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and provided acceptable planned corrective actions and a completion date (July 31, 2019) that was considered acceptable to OIG.

Recommendation 5:  Develop concise emergency exemption application guidance that specifies the minimum requirements of an application submission and is available on the OPP’s Section 18 website.

• OCSPP Response and OIG Resolution:  OCSPP did not agree or disagree with Recommendation 2, but it nevertheless proposed to:  (1) evaluate how its web resources can be enhanced to respond to this recommendation; and (2) if it determines that enhancements to the Section 18 website are necessary, implement any needed web updates by December 2019.  OIG does not believe the proposed corrective action for this recommendation is sufficient to meet the intent of the recommendation and states this recommendation remains unresolved.

Recommendation 6:  Provide clear guidance to state lead agencies on how and when they can use efficacy data from other state lead agencies to satisfy the emergency exemption application criteria.

• OCSPP Response and OIG Resolution:  OCSPP did not agree with this recommendation, stating that the only example provided by OIG to support this recommendation represents an extremely rare situation.  No corrective actions were proposed and this issue remains unresolved. 

Recommendation 7:  Expand the data presented in the OPP’s Section 18 database by considering additional data points, such as application acreage requested, actual acreage applied, and registration status of each exempted pesticide.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “consider additional data points, such as application acreage requested, decision documents, and registration status of each exempted pesticide, as OCSPP explores ways to improve the website database and its overall content.”  OCSPP proposed that by December 2019 recommendations would be made to the OPP Director for enhancing the Section 18 database and a memorandum would be provided to the OCSPP AA with a plan for updating the Section 18 database addressing these recommendations.  OIG states that OCSPP did not commit to expanding the data presented in the Section 18 database and, thus, this issue remains unresolved.

Recommendation 8:  Provide an annual update and information summary to state lead agencies to better inform them about any changes to the emergency exemption application-and-review process.

• OCSPP Response and OIG Resolution:  OCSPP agreed with this recommendation and stated it would “explore how to provide periodic and useful program updates to applicants.”  OCSPP proposed by that December 2019 it would “work with State Lead Agencies to identify the types of information they may find helpful for periodic updates” and “develop a strategy which details the activities that might be conducted to provide periodic and useful program updates to applicants.”  OIG states that OCSPP found the term “periodic” unclear and stated the issue remains unresolved.

Although several of these recommendations and EPA’s proposals remain unresolved, registrants should monitor for actions to be taken by EPA in response to the OIG Report. 

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.

Commentary

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 Timothy D. Backstrom and Lisa M. Campbell

On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC).  DPR states that this proposal is being presented “after an extensive period of scientific and public review.”  The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as a TAC.  To make that determination, DPR utilized an inhalation reference concentration (RfC) based on new animal studies with chlorpyrifos that reported neurodevelopmental effects at exposure levels well below the threshold for acetylcholinesterase (AChE) inhibition.  More information on DPR’s final TAC evaluation is available in our blog item "California DPR Releases Final Toxic Air Contaminant Evaluation for Chlorpyrifos."  In August 2018, DPR posted the Scientific Review Panel on TAC’s findings on chlorpyrifos and the Director’s Proposed Determination Concerning Chlorpyrifos as a TAC.

DPR is providing a 45-day public comment period (until November 9, 2018) on the proposed regulation to list chlorpyrifos as a TAC.  Written comments may be submitted to .(JavaScript must be enabled to view this email address).  In addition, DPR is holding a hearing to receive oral comments on this issue on November 8, 2018, at 2:00 p.m. (PT) at the California Environmental Protection Agency headquarters, 1001 I Street, in Sacramento, California.  DPR states that it anticipates that the proposed regulation to list chlorpyrifos as a TAC will be effective in 2019.  Even though DPR is proposing to list chlorpyrifos as a TAC, DPR states that “possible mitigation measures to protect human health and the environment will be considered through a subsequent process involving consultation with other state and local agencies including the Office of Environmental Health Hazard Assessment (OEHHA) and the California Air Resources Board (CARB).”

Commentary

The U.S. Environmental Protection Agency (EPA) previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos.  This determination was based primarily on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition, but the methodology used in these epidemiology studies has been harshly criticized by the pesticide industry.  In contrast, the DPR TAC proposal is predicated on a determination that new animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition, and DPR views the epidemiology studies utilized by EPA to make its FQPA determination as providing corroboration for the animal data.  At this juncture, it is not clear how EPA will characterize the new animal data concerning chlorpyrifos.  In any case, questions are likely to remain concerning EPA’s use of data concerning chorpyrifos to establish the FQPA safety factor for other organophosphate (OP) pesticides.

More information on chlorpyrifos issues and California DPR regulations is available on our blog.

By Margaret R. Graham

On September 20, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT).  The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.”

The webinar will be presented by Dr. Greg Kruger, a weed science and application technology specialist from the University of Nebraska-Lincoln and will cover different methods of ground application, best practices for reducing pesticide spray particle drift when using ground application equipment, and a discussion of the optimization of weed control.  Registration is available online.

More information on other pesticide applicator issues, including the Worker Protection Standard, is available on our blog.

By Lisa M. Campbell and Lara A. Hall, MS, RQAP-GLP

On August 21, 2018, the U.S. Environmental Protection Agency (EPA) announced it was posting new frequently asked questions (FAQ) for registrants and contract laboratories conducting honeybee toxicity testing.  EPA states that these FAQs are “made up of responses to inquiries EPA commonly receives about protocols used to generate honeybee toxicity data for submission in support of pesticide registration,” and are “meant to complement the Agency’s existing Pollinator Risk Assessment Guidance and increase the transparency and clarity of the risk assessment process.”  The FAQs include general study questions and questions related to specific kinds of contact toxicity, oral toxicity, chronic toxicity, toxicity of residues on foliage, and field and tunnel colony toxicity levels.  Questions not found in the FAQs or risk assessment guidance can be submitted to .(JavaScript must be enabled to view this email address).

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.”

Commentary

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

In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos.  This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP) which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP recommendations.  As part of their review of the December 2017 draft, the SRP recommended “additional and detailed review of developmental neurotoxicity studies, in particular recent in vivo animal studies as well as a more in depth analysis of human effects of chlorpyrifos” and “that DPR reevaluate the critical endpoints, the associated [(uncertainty factors (UF)], and the resulting [reference concentrations (RfC)] and [reference doses (RfD)] for each endpoint.”

DPR determines that a pesticide is a TAC for a non-cancer adverse effect if the projected air concentrations associated with use of the pesticide are more than one tenth of the inhalation RfC established based on animal toxicity and epidemiology data.  In the draft TAC evaluation for chlorpyrifos, DPR utilized the threshold for red blood cell acetylcholinesterase (AChE) inhibition in humans and a target margin of exposure (MOE) of 100, including a factor of 10 intended to account for potential neurodevelopmental effects below the threshold for RBC AChE inhibition.  In the final TAC evaluation for chlorpyrifos, DPR increased the MOE for AChE inhibition to 300, based on deficiencies in the human inhalation parameters used to model the threshold for AChE inhibition.

In addition, the final TAC evaluation establishes a new No Observed Effect Level (NOEL) for neurodevelopmental effects in animal studies with chlorpyrifos reported at exposure levels well below the threshold for AChE inhibition.  Based on this NOEL, DPR has derived a new inhalation RfC for neurodevelopmental effects, using a standard MOE of 100 consisting of 10X for interspecies sensitivity and 10X for intraspecies variability.  This new inhalation RfC based on neurodevelopmental effects in animal studies is about one-half the revised inhalation RfC based on the threshold for AChE inhibition.  Because the modeled spray drift air concentrations for chlorpyrifos are more than one tenth of this new inhalation RfC, DPR concludes “that chlorpyrifos meets the criteria to be listed as a TAC pursuant to the law of California.”

Commentary

In the final TAC evaluation for chlorpyrifos, DPR concluded that there is sufficient evidence from animal studies to establish a new NOEL for neurodevelopmental effects, which is well below the level that has been shown to cause AChE inhibition in the same animals.  Although the U.S. Environmental Protection Agency (EPA) has previously issued a determination that the default 10X safety factor for infants and children established by the Food Quality Protection Act (FQPA) should be retained for chlorpyrifos, this determination was based on epidemiology studies that purported to show adverse neurodevelopmental outcomes in humans at exposure levels below the threshold for AChE inhibition.  The methodology used in these epidemiology studies has been harshly criticized by the pesticide industry.  DPR views these epidemiology studies as providing corroboration, but the new DPR risk assessment is predicated instead on DPR’s view that animal studies with chlorpyrifos report neurodevelopmental effects below the threshold for AChE inhibition.  The DPR risk assessment based on these animal studies uses a standard MOE of 100.  How EPA may or may not view DPR’s conclusion is not known.  In light of the August 9, 2018, decision by the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) directing EPA to proceed with revocation of all tolerances and cancellation of all registrations for chlorpyrifos, the effect of the DPR conclusion on EPA actions is not clear.  Nevertheless, it is worth noting that, because the mechanism by which chlorpyrifos would cause such neurodevelopmental effects is unknown and is below the level that causes AChE inhibition, any presumption by EPA that other organophosphate (OP) pesticides may cause the same type of effects will likely be vigorously disputed by industry on scientific grounds.  

Please see our blog item Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos for more information on the Ninth Circuit’s August 9, 2018, decision.

By Lynn L. Bergeson and Carla N. Hutton

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms.  APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts.  Comments are due July 30, 2018.

Our full memorandum provides some background, context, and a commentary regarding APHIS’ announcement. 

By Timothy D. Backstrom

On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by the U.S. Environmental Protection Agency (EPA) to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC).  The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug, and Cosmetic Act (FFDCA) and all chlorpyrifos registrations granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  After a series of delays and court decisions concerning EPA action on the 2007 petition, the Ninth Circuit issued a writ of mandamus in In re PANNA v. EPA requiring that EPA take action to grant or to deny the petition no later than March 31, 2017.   Although EPA proposed in November 2015 to partially grant the 2007 petition and to revoke all chlorpyrifos tolerances based on concerns about neurodevelopmental effects in children, EPA ultimately decided to deny the entire PANNA and NRDC tolerance revocation petition in a decision dated March 29, 2017.  More information on EPA’s March 29, 2017, decision is available in our blog item “EPA Denies Petition to Ban Chlorpyrifos.”

After the March 29, 2017 denial decision, the Ninth Circuit denied a motion for further mandamus relief in the PANNA case.  The court stated that, once EPA denies a tolerance revocation petition under FFDCA, “[f]iling objections and awaiting their resolution by the EPA Administrator is a prerequisite to obtaining judicial review of EPA’s final response to the petition.”  The petitioners in the current LULAC case filed administrative objections to EPA’s denial decision on June 5, 2017, but, on the same date, they also brought a new action seeking immediate judicial review.  Five States and the District of Columbia subsequently intervened in the new case.  EPA filed a motion to dismiss the LULAC case for lack of jurisdiction on August 21, 2017, but the court denied that motion, without prejudice to EPA renewing its jurisdictional arguments during briefing on the merits.

Background to Tolerance Petition Decision

EPA’s risk assessments concerning the potential neurodevelopmental effects of chlorpyrifos have been the subject of scientific controversy for a number of years.  In decisions that were the subject of significant criticism and controversy, EPA scientists construed the associations reported in certain epidemiological studies of exposure to chlorpyrifos as evidence that chlorpyrifos may cause neurodevelopmental effects in children at exposure levels that are less than the threshold for induction of acetylcholinesterase inhibition.  In November, 2016, EPA issued an updated risk assessment for chlorpyrifos and all organophosphate (OP) pesticides based on the same epidemiology studies, which included a determination that EPA would retain the default 10X safety factor established by the Food Quality Protection Act (FQPA) for chlorpyrifos and for all OP pesticides.  Pesticide industry representatives have raised concerns about the design and conduct of the chlorpyrifos epidemiology studies, the scientific plausibility of the proposed association of neurodevelopmental effects with low level chlorpyrifos exposure, and the rationale for extending the FQPA determination to OP pesticides other than chlorpyrifos.

Prior to the change in administration in 2017, it appeared that EPA would proceed with its 2015 proposal to revoke chlorpyrifos tolerances based on the 2016 updated risk assessment.  Instead, on March 29, 2017, EPA decided to deny the 2007 petition and to defer its ultimate scientific decision concerning the neurodevelopmental effects of chlorpyrifos until after EPA completes the currently pending registration review process for chlorpyrifos.

Briefs in the LULAC Case

In their briefs, the petitioners and the intervenors in the LULAC case have objected to further delay in EPA’s scientific decision concerning the neurodevelopmental risks presented by chlorpyrifos, as well as to the procedures specified by FFDCA that would require that they await resolution of their objections before seeking judicial review.  From their perspective, EPA has already determined repeatedly that continued chlorpyrifos exposure is unsafe for infants and children, and EPA is therefore required to proceed with immediate revocation of all chlorpyrifos tolerances.

In their briefs, the petitioners and the intervenors argued that the procedures required by FFDCA are not jurisdictional, and that the court therefore has discretion to waive exhaustion of these procedures.  They also argued that exhaustion should be waived in this instance because allowing EPA time to rule on their objections would ultimately be futile, and because further delay would perpetuate EPA’s purported disregard of the FFDCA safety standard.  Further, they argued that, if immediate review is not available under FFDCA, it should be available under FIFRA because EPA also denied a request to cancel the FIFRA registrations for chlorpyrifos.  Finally, the petitioners requested during briefing that the court issue “a writ of mandamus directing EPA to decide LULAC’s objections within 60 days.”

In its brief, EPA argued that the petitioners lack any jurisdiction to bring the current case because the detailed procedures specified in the FFDCA are jurisdictional in nature, and exhaustion of these procedures therefore cannot be waived by a reviewing court.  EPA also argued that, even if the court could waive the exhaustion requirement, the petitioners have raised the same issues in their objections as they raised in their briefs, and there is no basis for the court to presume that allowing EPA to address these issues would be futile.  Moreover, EPA argued that FFDCA Section 346a(h)(5) expressly precludes separate judicial review under FIFRA of EPA’s decision concerning the 2007 petition.  Finally, EPA contended in its brief that the petitioners’ request for a writ of mandamus must be denied because the petitioners did not follow the procedure for making such a request in Federal Rule of Appellate Procedure 21(a).

Commentary

During the oral arguments on July 9, 2018, two of the three judges on the Ninth Circuit panel reportedly expressed frustration concerning the prospect for years of further delay before EPA makes its ultimate decision concerning chlorpyrifos.  Although it is not clear how the court would overcome the formidable jurisdictional barriers to immediate judicial review, it appears that some sort of judicial decision or order compelling EPA to take more immediate action on chlorpyrifos is a possibility. More information regarding these proceedings is available on our blog under key word chlorpyrifos.

By Heather F. Collins, M.S., and Sheryl Lindros Dolan

On June 21, 2018, during the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) webinar, EPA discussed the new draft risk-based strategy for ensuring the performance of public health antimicrobial products and announced the intended replacement of the former Antimicrobial Testing Program (ATP) with the new Antimicrobial Product Evaluation Program (APEP).  Comments on the draft risk-based strategy may be submitted to EPA until July 16, 2018.

Public health antimicrobial products are those products that bear a claim to control microorganisms that pose a threat to human health, and whose presence cannot readily be observed by the user, including microorganisms infectious to people in any area of the inanimate environment.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires product performance (i.e., efficacy) data to support registration of antimicrobial products bearing a public health claim. 

EPA began the webinar with an overview of the Office of Inspector General (OIG) Report entitled “EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants.”  Report #16-P-0316 (Sept. 19, 2016).  OIG conducted a review of EPA’s ATP to “determine whether the program ensures the efficacy of EPA-registered hospital sterilants, disinfectants, and tuberculocides (“hospital-level disinfectants”); and to evaluate options for improving the ATP.”  See Bergeson & Campbell, P.C.’s article dated September 21, 2016, “Results of EPA OIG’s Review of EPA’s Antimicrobial Testing Program” for a full summary of the OIG report.  In the 2016 report, OIG recommends OPP suspend administering the current ATP and develop a risk-based strategy to assure the effectiveness of public health pesticides used in hospital settings once products are in the marketplace.  EPA agreed with OIG’s recommendations.

EPA provided that “[t]he intent of the [APEP] is to ensure continued effectiveness of antimicrobial products with public health claims (hospital disinfectants, tuberculocides, and other health care claims) in the marketplace.  The maintenance and development of technically-sound test methods, quality improvement tools (e.g., peer review of new protocols), and outreach and stewardship activities will further support the program.” 

The risk-based testing strategy will ensure the effectiveness of public health pesticides used in hospital settings by:

• Establishing a framework for periodic testing after registration;
• Defining a program that is responsive to current public health risks;
• Identifying risk factors for selecting products to test;
• Establishing a process to be used for obtaining samples for testing; and
• Setting a date to begin risk-based post-registration testing.

Risk-based factors under consideration by EPA include:

• Use of healthcare-associated infection data reports;
• Claims against microorganisms of greatest concern to healthcare-associated infections (e.g., Clostridium difficile, MRSA,VRE);
• Emerging pathogens and homeland security considerations;
• Trends in previous ATP compliance history (e.g., claims against Mycobacterium bovis BCG);
• Atypical label claims (e.g., very short contact times, use sites and surfaces, new product delivery and application procedures); 
• Claims not evaluated under the previous ATP;
• New and unusual active ingredients;
• Formulation chemistry-related issues (e.g., shelf-life/stability once prepared, lack of expiration dates);
• Use of new or procedurally-revised test methods;
• Tips and complaints;
• Issues identified during reregistration (e.g., frequency of repeat testing, acceptance criteria not met); and
• Link to other federal initiatives.

OIG recommends a functional program begin after registration review is completed in 2022.  According to OIG, the development of a solid, acceptable testing strategy is key -- the strategy must be finalized and communicated to regulated and public health communities.  OIG specified other EPA outreach activities for the testing program that must be considered, e.g., setting and clearly communicating goals and establishing the baseline reporting mechanisms.

EPA expects to release this final strategy in November 2018 and seeks public input prior to implementation.  Please submit your comments on this topic by July 16, 2018, to the Office of Pesticide Programs Docket, EPA-HQ-OPP-2018-0265 at https://www.regulations.gov.

For additional information, please visit https://www.epa.gov/pesticide-registration/antimicrobial-testing-program or https://www.epa.gov/pesticide-registration/webinar-risk-based-strategy-ensure-continued-effectiveness-hospital.

By Timothy D. Backstrom and Lisa M. Campbell

On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497).  These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991.  The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018.  Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg. 17595) to delay the general compliance date for an additional six-month period, and to allow regulated entities to implement certain burden-reducing provisions during this interim period. 

The rule delaying the effective date of the 2017 revisions for an additional six months takes effect on July 19, 2018.  In the period between July 19, 2018, and January 21, 2019, regulated entities must continue to comply with the requirements of the human testing policy as it was in effect prior to the 2017 revisions.  Notwithstanding this general rule, affected institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions.  Those three provisions are:

• The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;
• The elimination of the requirement for annual continuing review with respect to certain categories of research; and
• The elimination of the requirement that institutional review boards (IRB) review grant applications or other funding proposals related to the research.

The principal purposes of the additional delay in implementation of the 2017 revisions to the human testing Common Rule are to allow more time for affected institutions to prepare for compliance and for the federal agencies that have adopted the new policy to issue further guidance.  The final rule states that the agencies do not expect that any additional delay in the implementation of the policy will be needed.

More information on the federal policy for the protection of human subjects is available in our blog under key phrases human subjects and common rule.

By Timothy D. Backstrom and Lisa M. Campbell

On June 14, 2018, the U.S. Environmental Protection Agency (EPA) announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use.  The prepublication version of the NOA is available on EPA’s website.  The NOA confirms that the publication “triggers the WPS requirement that training programs must include all of the topics specified in the 2015 revisions to the WPS.”  Because the 2015 WPS rule is already in effect, employers must provide expanded training addressing these topics within 180 days of publication.  The expanded training materials that are the subject of the NOA were developed through a cooperative agreement with the Pesticide Education Resources Collaborative (PERC), and are available on PERC’s website.

EPA previously issued a Federal Register notice on December 21, 2017, stating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zone.”  In this 2017 notice, EPA stated that it did not expect to issue the NOA for  training materials addressing the 2015 WPS rule until after completing a rulemaking concerning these proposed revisions.  This deferral of the NOA would have significantly delayed the expanded training for handlers and agricultural workers contemplated by the 2015 rule.  In the NOA, EPA states that it is still reconsidering the same three requirements, and that “if those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.”

On May 30, 2018, two complaints were filed against EPA in the United States District Court for the Southern District of New York challenging EPA’s decision to defer publication of the NOA.    More information on these lawsuits is available in our blog item "Lawsuits Filed in Federal District Court Regarding WPS Training Delay."  Because publication of the new NOA will afford the plaintiffs in these cases all of the substantive relief they were seeking, it appears that these actions will now be moot other than any request for attorney’s fees and costs incurred by the plaintiffs.

More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.

By Carla N. Hutton and Jessie Nguyen

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to pesticides:

• Pesticides; Expansion of Crop Grouping Program (RIN 2070-AJ28):  EPA is revising in phases the current pesticide crop grouping regulations to create new crop groupings, add new subgroups, and expand existing crop groups by adding new commodities.  EPA plans to propose a fifth phase by February 2019 and a sixth phase by August 2019;
• Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register (RIN 2070-AK06):  EPA is considering revising several procedural regulations that require it to use a notice published in the Federal Register “to provide information and notice concerning registration of a pesticide product with a new active ingredient or new use; announce approvals of specific quarantine and public health exemptions; and summaries of certain state registrations.”  Instead, EPA would provide the same information on a consolidated website.  EPA plans to issue a notice of proposed rulemaking (NPRM) in September 2018;
• Pesticides; Certification of Pesticide Applicators Rule; Reconsideration of the Minimum Age Requirements (RIN 2070-AK37):  In spring 2017, EPA solicited comments on regulations that may be appropriate for repeal, replacement, or modification.  EPA states that it received comments specific to the January 4, 2017, certification rule and has decided to reconsider one requirement of the final rule.  EPA intends to publish an NPRM in September 2018; and
• Pesticides; Agricultural Worker Protection Standard (WPS); Reconsideration of Several Requirements (RIN 2070-AK43):  As reported above, in spring 2017, EPA solicited comments on regulations that may be appropriate for repeal, replacement, or modification.  EPA received comments suggesting specific changes to the 2015 revised WPS requirements.  Based on comments raised, EPA intends to publish an NPRM in September 2018.

By Timothy D. Backstrom

On May 30, 2018, two complaints were filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Southern District of New York.  Both of these suits concern a decision by EPA to defer publication of a notice of availability (NOA) of training materials prepared pursuant to the Agricultural Worker Protection Standard (WPS), 40 C.F.R. Part 170.  The WPS was originally promulgated in 1974, substantially amended in 1992, and then revised again in 2015.  Although the 2015 revisions to the WPS are currently in effect, employers are not required to adopt new training programs for agricultural workers and handlers until 180 days after EPA publishes the NOA announcing the availability of the new training materials in the Federal Register. 

On December 21, 2017, EPA issued a Federal Register notice indicating that it “expects to publish a Notice of Proposed Rulemaking in FY 2018 to solicit public input on proposed revisions to the WPS requirements for minimum age, designated representative, and application exclusion zones.”  In this 2017 notice, EPA acknowledged that the WPS provisions it will propose to revise are already in effect and that training materials consistent with the 2015 rule have already been prepared, but stated that EPA does not expect to issue the NOA for these new training materials until after it completes a rulemaking concerning the proposed revisions to the 2015 WPS rule.  The plaintiffs in both of the new district court cases are challenging the decision of EPA to defer issuance of the NOA, which has delayed the timetable for expanded training for agricultural workers and handlers contemplated by the 2015 WPS rule.

The first of two complaints was filed by Rural & Migrant Ministry, et al. (RAM) v. EPA, Case No. 1:18-cv-04743.  RAM’s complaint includes four causes of action based on EPA’s failure to issue the NOA.  RAM alleges that this failure is “arbitrary and capricious,” constitutes “agency action unlawfully withheld and unreasonably delayed,” and violates the publication requirements of the Administrative Procedure Act (APA) and the Federal Register Act.  RAM requests a declaratory judgment that EPA has violated the APA and the Federal Register Act, and injunctive relief to require immediate publication of the NOA.

The second complaint was filed by the States of New York, California, and Maryland, New York v. Pruitt, Case No. 1:18-cv-04739.  These State plaintiffs also contend that EPA’s failure to publish the NOA is “arbitrary and capricious,” and constitutes “action unlawfully withheld or unreasonably delayed.”  Like RAM, the State plaintiffs seek a declaratory judgment and an injunction requiring that EPA immediately publish the NOA for the expanded training materials.  EPA will presumably seek consolidation of the two cases, which both challenge the same EPA actions and seek comparable relief.

The principal question presented by these two WPS cases is whether EPA can lawfully defer full implementation of the expanded training required by the 2015 WPS while it undertakes and completes a new rulemaking to revise certain provisions of the same rule.  Although EPA acknowledges that it has prepared the written materials needed to effectuate the expanded training required by the 2015 WPS, EPA will likely argue that it is both more efficient and less confusing for employers and workers to use the existing training materials until after EPA has finished revising the WPS.  In contrast, the plaintiffs in these two cases will argue that the 2015 WPS is already in effect, and that the protection for workers associated with the expanded training required by this rule has been improperly delayed by EPA without any prior notice and comment rulemaking.

The decision by EPA to defer full implementation of the 2015 WPS while EPA considers potential revisions to the WPS may be deemed analogous in some respects to other EPA actions that delayed the effective date for a rule expanding requirements for certified applicators who apply restricted use pesticides (RUP).  In a decision issued by the U.S. District Court for the Northern District of California on March 21, 2018, the court vacated several EPA actions that had delayed the effective date for the RUP rule, holding that EPA was required to provide notice and opportunity for comment before taking such actions and that EPA lacked “good cause” for acting without notice and comment.  See Order Granting Plaintiffs’ Motion for Summary Judgment, Pineros Y Campesinos Unidoa Del Noroeste v. Pruitt, Case No. 17-cv-03434-JSW.

The current cases may be distinguished from the actions EPA took to defer the effective date for the RUP rule because EPA has declined to take affirmative action to effectuate certain requirements in the 2015 WPS, rather than deferring the effective date for any of the requirements in that rule.  It remains to be seen whether the district court will consider this procedural distinction to warrant a different outcome.

More information on WPS issues is available on our blog under key words Worker Protection Standard, delay, guidance, and training.