By Lynn L. Bergeson and Margaret R. Graham, M.S.
EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines. Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review. The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia. The meeting will also be available via webcast.
EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998. EPA’s Charge Questions state that “[t]o increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.” Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”
EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines. EPA states that it is committed to reducing the use of animals in testing but, at this time, no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies. EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.
Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website. EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 19, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on May 8, 2019, from 9 a.m. to 5 p.m. and May 9, 2019, from 9 a.m. to 12:00 p.m. (EDT) in the first-floor conference center at One Potomac Yard South, 2777 South Crystal Drive in Arlington, Virginia. 84 Fed. Reg. 16486. The Federal Register notice states that the agenda is not yet available but that this meeting will provide advice and recommendations to EPA’s Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The draft agenda will be available on or before May 5, 2019, on the PPDC webpage. The meeting is open to the public and no advance registration is required.
This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides: past, present, and future.
In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it. Listen to the full episode and subscribe here.
By Lisa M. Campbell and Lisa R. Burchi
On February 6, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting the U.S. Environmental Protection Agency’s (EPA) and Acting EPA Administrator Andrew Wheeler’s (collectively EPA or Respondents) September 24, 2018, petition for an en banc rehearing concerning the Ninth Circuit’s August 9, 2018, decision that vacated an EPA order maintaining chlorpyrifos registrations and remanded the case to EPA with directions to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.
The Ninth Circuit’s order granting the Respondent’s petition that the case be re-heard en banc does not provide an explanation for its decision. The Ninth Circuit evidently found the arguments offered by Respondents and other interested parties that filed amicus curiae briefs more persuasive than Petitioners’ brief (including the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC)), who argued against submission of certain amicus curiae briefs and also that, with limited exception, Respondent’s petition for rehearing lacked merit and should be denied.
The en banc oral argument will be held March 26, 2019, at 2:30 p.m. (PST).
Arguments for Rehearing
Prior to the February 6, 2019, order, on October 15, 2018, three amicus curiae briefs were filed in support of EPA’s petition by CropLife America (CLA), Agribusiness Council of Indiana (Agribusiness), and Dow Agrosciences LLC (DAS). Despite Petitioners’ objection to the motions of Agribusiness and CLA for leave to file amicus curiae briefs in support of Respondent’s petition for rehearing, on November 13, 2018, the Ninth Circuit granted the motions for leave to file amicus curiae briefs.
EPA’s petition for rehearing made multiple arguments as to why an en banc and panel rehearing should be granted, including the Panel’s lack of jurisdiction, the Panel’s order conflicting with applicable Supreme Court precedent, and specific modifications to be addressed to the order to comply with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements. More information regarding EPA’s petition is available in our blog item “EPA Petitions for En Banc and Panel Rehearing in Ninth Circuit Chlorpyrifos Case.”
The amicus curiae briefs supported EPA’s arguments and also made arguments supporting rehearing in addition to those previously set forth by EPA. CLA’s brief focused on the fact that the Panel’s decision disregarded FIFRA’s cancellation process, stating: “if EPA ultimately were to determine that any chlorpyrifos registration would need to be cancelled, such an action could not be accomplished in the way the panel majority prescribed: by circumventing the procedures Congress required to ensure that pesticide cancellation decisions are not made unless and until these harms and the best science available are properly vetted.” DAS’ brief addressed in detail the Panel’s violation of administrative law in dictating how EPA must act (i.e., cancel the chlorpyrifos registrations) and the potential violation of FIFRA by EPA if forced to comply with the Panel’s order regarding the timing for cancelling such registrations. The amicus curiae briefs also sought to provide information on the practical consequences that chlorpyrifos registrants and users would face if the panel opinion is not revised. For example, DAS discussed its proprietary interest in protecting its registrations and defending its product, while Agribusiness in its brief provided some background on the use and benefits of chlorpyrifos, the lack of viable alternatives, and the ramifications of the order on insect pest resistance and the ability to combat new invasive pests.
Petitioners’ response to the petition for rehearing and rehearing en banc argued that there was no basis for rehearing. Petitioners noted that en banc review is “disfavored” and appropriate in limited “extraordinary circumstances” and in the face of “an irreconcilable conflict between the holdings of controlling prior decisions of this court.” Petitioners argued that the Panel decision was in accord with precedent and that a request for rehearing “would only result in further delay.” Petitioners did concede on two points: (1) modifying the order to direct EPA to cancel the registrations under the FIFRA cancellation process, which necessitates more time than the 60 days set forth in the order; and (2) clarifying that the order is limited to cancelling registrations that can result in residues on food.
EPA, chlorpyrifos registrants and users, and industry generally should be encouraged by the decision to grant an en banc rehearing in this case, but the outcome is far from certain. Given the issues at stake, registrants should monitor this hearing closely.
By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan
Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.
Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown. According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned. Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends. For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.
The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally. Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR. This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress. Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.
This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.
Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications. OPP states on its web site:
- Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
- Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
- Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.
Registrants should monitor developments closely.
By James V. Aidala and Lisa M. Campbell
On December 19, 2018, the Senate passed a short-term Continuing Resolution (CR) to prevent a government shutdown and continue funding for the government through February 8, 2019. Currently, however, given the uncertainty over border wall funding, it appears likely that there may well be a government shutdown for some period of time. Until the immigration issue is ultimately resolved in an eventual agreement, however, the majority and Democratic staff of the U.S. House of Representatives Agriculture Committee expect that the Pesticide Registration Improvement Act (PRIA) extension will be included in the CR. Both the majority and minority in both the House and Senate have reportedly agreed to support PRIA in the new year.
The recent House Conference Report for H.R. 2, the Agriculture Improvement Act of 2018, or the Farm Bill, deleted previously inserted provisions regarding the Pesticide Registration Improvement Enhancement Act of 2017. The House version of the Farm Bill included the enactment of the Pesticide Registration Improvement Enhancement Act of 2017 (H.R. 1029, Section 9119), but the Senate version contained no comparable provisions. More information on the Farm Bill Conference Report is available in our memorandum “Congress Passes Farm Bill Conference Report.”
The positive news is that many members of both the House and Senate appear to remain committed to legislative reauthorization of PRIA. At the same time, with the change in party control in the House of Representatives, reauthorization may continue to be delayed as the new Congress with new Committee leadership devotes time and energy to competing priorities.
In addition, as PRIA amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it could provide an opportunity for amendments to FIFRA outside of the funding context to be offered by members interested in other pesticide-relevant issues. Debate on additional pesticide issues would only likely lead to further delay and uncertainty about long-term reauthorization of PRIA.
By Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
By Lynn L. Bergeson and Carla N. Hutton
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.”
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.
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:
- 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.
- 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.
- 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.