Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.
On October 19, 2018, the U.S. Environmental Protection Agency (EPA) posted the Final Work Plan (FWP) for the nanosilver registration review process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.” According to the FWP, EPA has identified the following use patterns to date: swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics. The FWP states that people may be exposed to nanosilver through inhalation and dermal exposures while applying the products to swimming pools and from incidental oral exposures during swimming. Further exposures may come from material preservative uses either while applying or from nanosilver that leaches out when textiles and plastics are washed. Nontarget organisms can be exposed when swimming pool water is released or when nanosilver used as a material preservative leaches.
According to the FWP, EPA “anticipates the need to require generation and submission of human health hazard and exposure data and to conduct a human health risk assessment for nanosilver during registration review.” The FWP states that EPA plans to conduct an environmental risk assessment for the nanosilver uses, “particularly focusing on materials preservative uses, such as plastics and textiles if the particular nanosilver chemistries are shown to leach, and swimming pool uses.” Any of the other use patterns may also be subject to ecological assessment if the fate and product chemistry profiles indicate the potential for environmental exposures. According to the FWP, the risk assessment integrates the environmental fate and effects data to determine if any uses pose risks to nontarget organisms. Potential risks to fish, aquatic invertebrates, aquatic plants, and birds and mammals will be assessed after the data gaps specified in the FWP are satisfied and the relevant data are available.
EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity. EPA anticipates issuing in 2018 a DCI requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.”
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on November 1, 2018, from 8:30 a.m. to 12:00 p.m., it will be hosting an informational seminar on biotechnology-pesticide issues for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, Virginia, in the lobby-level Conference Center. EPA’s draft agenda for the PPDC meeting has been posted to the PPDC website.
The PPDC meeting agenda lists the following seven sessions:
Nancy Beck, Ph.D., Deputy Assistant Administrator of the Office of Chemical Safety and Pollution Prevention and Richard Keigwin, OPP Director, will make the opening remarks. After the sessions, EPA is providing a 15-minute window for public comments. PPDC meetings are free, open to the public, and no advance registration is required.
EPA Requests Public Nominations for FIFRA SAP; Requests Independent Scientific Advice on Health and Safety Issues
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.
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.
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:
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.
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.
Recommendation 3: Update and prepare the draft standard operating procedure in final that OPP uses to guide the emergency exemption process.
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.
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.
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.
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.
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.
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.
On September 24, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents U.S. Environmental Protection Agency (EPA) and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke all tolerances and cancel all registrations for chlorpyrifos, and that specifically directed EPA to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days. More information regarding the August 9 decision is available in our blog item “Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos.”
EPA’s petition for rehearing sets forth three discrete procedural arguments as to why rehearing should be granted. The first argument is that the panel erred because “an initial decision denying an administrative petition under 21 U.S.C. § 346a(d)(4)(A)(iii) is simply not within the jurisdiction of this Court to review ….” EPA contends that the decision to grant judicial review of the initial EPA order, without waiting for EPA to respond to objections or to issue a final order, conflicts with the applicable precedent in both the Ninth Circuit and the U.S. Court of Appeals for the Second Circuit (Second Circuit).
EPA’s second argument is that, even if the initial EPA order is deemed to be reviewable, the panel’s decision directing EPA to take specific actions on remand “exceeded the remedial authority granted the courts by Congress” and conflicts with applicable Supreme Court precedent. EPA identifies some other actions that EPA could hypothetically have decided to take on remand, including denying the administrative petition based on a finding that the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standard is met, reducing the affected tolerances, or revoking only certain tolerances. EPA argues that the court was not empowered to direct EPA to take specific actions, but should have instead remanded the matter to EPA “for further consideration in light of the panel’s holding that EPA may not ‘decline to revoke chlorpyrifos tolerances [without] mak[ing] a finding of reasonable certainty that the tolerances were safe.’”
EPA’s third argument is that, in the event a broader rehearing is not granted, a rehearing by the panel should nonetheless be convened to modify the relief ordered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA argues that revocation of the chlorpyrifos tolerances would not lead automatically to cancellation of all chlorpyrifos registrations, because there are also some non-food uses for chlorpyrifos. EPA states that “FIFRA incorporates the safety standard of the FFDCA only with respect to food-use pesticides …” (emphasis in original). EPA also notes that EPA lacks authority to comply with the court’s order to cancel all chlorpyrifos registrations within 60 days, because EPA must follow the statutory procedure for cancellation under FIFRA Section 6(b), which requires EPA to forward a proposed cancellation first to the U.S. Department of Agriculture (USDA) and the FIFRA Scientific Advisory Panel (SAP), and to afford the affected registrants and other adversely affected persons an opportunity to request an adjudicatory hearing to contest the proposed cancellation. EPA states that the panel should provide at least a limited rehearing, because it granted relief without the benefit of any prior briefing on remedy in which these significant problems would have been identified.
Although parties to appellate litigation often seek rehearing or rehearing en banc, federal agencies represented by the U.S. Department of Justice (DOJ) are considerably more selective about the circumstances in which they will file a petition for rehearing. There are some compelling arguments supported by precedent that judicial review is not available under the FFDCA for the type of initial order concerning which the petitioners in this case sought review. Moreover, EPA has identified some practical factors which make it literally impossible for EPA both to adhere to mandatory statutory procedures under FIFRA and to comply with the terms of the court’s order. For this reason, even if a broader rehearing is not granted concerning the jurisdictional question or the authority of the court to order EPA to take specific actions, a narrower rehearing before the appellate panel may be ordered, which would allow the parties an opportunity for further briefing on remedy and permit the court to modify its order.
More information on chlorpyrifos issues, including further proceedings in this case, is available on our blog under key word chlorpyrifos.
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.
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.
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.
On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.” A separate dissent stated that the court should have dismissed the case for lack of jurisdiction. Please see our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017.
EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because Section 408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1).The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.”In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order.
After concluding that the objections process is not jurisdictional in character, the majority next considered whether the petitioners should nonetheless be required to exhaust their administrative remedies by waiting until EPA responds to their objections before obtaining judicial review.Although FFDCA Section 408(g)(2)(C) requires EPA to rule on the objections “as soon as practicable,” EPA had taken no action for 13 months after the objections were filed.The majority concluded that the exhaustion requirement should be waived “in light of the strong individual interests against requiring exhaustion and weak institutional interests in favor of it.”
EPA did not specifically address the substantive merits of the 2017 order in its brief, and the majority found that EPA has consequently “forfeited any merits-based argument.”The 2017 order was issued in the context of an administrative record in which EPA has repeatedly determined that the FFDCA standard for maintenance of chlorpyrifos tolerances (“a reasonable certainty that no harm will result from aggregate exposure to the pesticide”) could not be met because of the risk of neurodevelopmental effects. The standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) incorporates this same FFDCA standard. Although the 2017 order stated that “the science addressing neurodevelopmental effects is unresolved,” it did nothing to alter these prior EPA determinations. The majority noted that EPA’s assertion that “significant uncertainty” remains regarding the health effects of chlorpyrifos being directly at odds with the “reasonably certainty” standard and “therefore mandates revoking the tolerance under [FFDCA Section 408(b)(2)(A)(i)].” The majority concluded that the possibility that future evidence may contradict EPA’s current determinations cannot justify continued inaction, and that the failure of EPA to proceed with the revocation of the tolerances and the cancellation of the registrations for chlorpyrifos “has now placed the agency in direct contravention of the FFDCA and FIFRA.”
The court’s direct instruction requiring EPA to proceed promptly with revocation of all tolerances and cancellations of all registrations for chlorpyrifos represents an unusually aggressive judicial intervention in the administrative process.Nevertheless, this outcome must be viewed in the context of an eleven year history beginning with an administrative petition that requested the same relief, followed by a writ of mandamus in 2015 from the same court requiring EPA to make a prompt decision on the petition.Although substantial controversy remains concerning the correct interpretation of epidemiology studies with chlorpyrifos, it appears that the court believes that EPA has not taken any action that would support a change in EPA’s prior conclusion that these studies constitute evidence of potential neurodevelopmental effects in children at chlorpyrifos exposure levels below the threshold for acetylcholinesterase (AChE) inhibition. Had EPA’s 2017 denial of the administrative petition been accompanied by an amended risk assessment for chlorpyrifos which articulated a changed conclusion, the court may have been less likely to substitute its judgment for that of EPA.The court seemed to find that because the scientific assessments in the current administrative record could not support the “reasonable certainty” standard in the FFDCA, the conclusion it reached on the merits was unavoidable.
Please see our blog item “Oral Argument Held in Case Challenging EPA’s Denial of Petition to Revoke Chlorpyrifos Tolerances” for information on the oral argument that took place on July 9, 2018, and the briefing in this case. Further information on the case proceedings is available on our blog under key word chlorpyrifos.
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.”
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.
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.
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).
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.
Antimicrobial Product Evaluation Program (APEP) for Products with Public Health Claims in the Marketplace
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:
Risk-based factors under consideration by EPA include:
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.
EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions May Utilize Three Burden-Reducing Provisions during the Delay
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 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.
EPA to Publish NOA for WPS Training Materials; Employers Required to Provide Expanded Training within 180 Days
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.