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 Timothy D. Backstrom
On December 12, 2018, the U.S. Environmental Protection Agency (EPA) announced a proposed joint stipulation and proposed stipulated notice of dismissal for Ellis v. Keigwin, No. 3:13-CV-1266 (N.D. Cal). 83 Fed. Reg. 63865. The Federal Register notice states that the parties are “proposing to reach a settlement in the form of a joint stipulation" that would, among other provisions “set a June 30, 2022, deadline for EPA to complete ESA [Endangered Species Act] effects determination for EPA’s registration reviews of clothianidin and thiamethoxam and, as appropriate, request initiation of any ESA consultations with the FWS [U.S. Fish and Wildlife Service] that EPA may determine to be necessary as a result of those effects determinations.” EPA would “also agree to initiate informal consultation" with the FWS prior to completing its effects determinations. In addition, defendant-intervenors Syngenta, Bayer, and Valent (the registrants of products containing clothianidin and thiamethoxam) have agreed to request that EPA voluntarily cancel the registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(b)(1) for 12 specific products that contain either clothianidin or thiamethoxam. EPA is requesting comments on both the proposed joint stipulation and the stipulated notice of dismissal. Comments are due by January 11, 2019.
The proposed joint stipulation and dismissal have been agreed to by all parties, including the plaintiffs, EPA, and defendant-intervenors Bayer, Syngenta, Valent, and CropLife America. This stipulation was negotiated by the parties after the District Court in the Ellis case issued an order ruling on cross motions for summary judgment on May 8, 2017. In that order, the court dismissed plaintiffs’ claims that EPA improperly denied a petition requesting that EPA immediately suspend products containing clothianidin, and also dismissed other claims that EPA violated FIFRA requirements for products containing clothianidin and thiamethoxam. At the same time, the court granted summary judgment for the plaintiffs on claims arising under ESA Section 7(a)(2), because EPA had failed to consult with FWS before taking particular actions concerning 59 pesticide products containing clothianidin or thiamethoxam. As part of the order, the court directed the parties to schedule a settlement conference to discuss an appropriate remedy, and the proposed stipulation is the result of those settlement discussions.
The Ellis case was brought by beekeepers and honey producers who wanted EPA to take immediate action to ban or restrict clothianidin and thiamethoxam products based on their belief that these neonicotinoid active ingredients pose an unacceptable risk to pollinator species. The court found that the plaintiffs did not demonstrate that these registered pesticidal active ingredients present an "imminent hazard" that would warrant suspension or emergency suspension under FIFRA Section 6(c), and the court also rejected the plaintiffs' other FIFRA claims concerning these products. In contrast, the court granted relief under the ESA because EPA did not make the required effects determinations concerning endangered and threatened species before taking various registration actions for pesticides containing these active ingredients, and the plaintiffs asserted a specific interest in those endangered or threatened species that might be adversely affected by these products. At this juncture, it is unknown whether the ESA review required by the agreed joint stipulation will lead to any further restrictions on these active ingredients that would have a collateral benefit for domesticated pollinators.
The proposed joint stipulation and the proposed stipulated notice of dismissal are available in EPA Docket No. EPA-HQ-OGC-2018-0745.
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.
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 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 Lisa M. Campbell and Lisa R. Burchi
On April 30, 2018, the U.S. District Court for D.C. issued a memorandum opinion that sets forth the reasons for its denial of defendant Monsanto Company’s (Monsanto) motion to dismiss in a case in which the plaintiffs allege that certain glyphosate label claims violate the District of Columbia Consumer Protection Procedures Act (DCCPPA) (Opinion). The order denying Monsanto’s motion to dismiss was issued on March 31, 2018, but did not provide any substantive discussion as to why it was denied, only that a statement that the reasons would be provided in 30 days.
Plaintiffs Beyond Pesticides, et al.’s amended complaint alleges that under the DCCPPA “the claim that Roundup targets an enzyme ‘found in plants but not in people or pets’ is false and misleading because that enzyme ‘is found in people and pets’” (emphasis in original), because, plaintiffs assert, “glyphosate, the active ingredient in Roundup, targets an enzyme that exists in ‘gut bacteria’ found in humans and other mammals.” The amended complaint additionally alleges that Monsanto “is aware that its labels and advertising are false … but continues to repeat this claim because ‘consumers are more likely to buy -- and will pay more for -- weed killer formulations that do not affect people and animals.’”
Monsanto’s motion to dismiss, filed on July 10, 2017, stated that plaintiffs’ “claims are time-barred, that Plaintiffs fail to state a claim because the statement at issue is not false or misleading, and that Plaintiffs’ claims are preempted by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].”
The Opinion outlines the reasons for the court’s conclusion that the claims are not time-barred, at least for purposes of deciding the motion to dismiss. The Opinion states, in response to some of the arguments that the claims were time-barred, that the court has “little trouble concluding that Plaintiffs’ claims are not time-barred in their entirety,” and that Monsanto is “entitled to renew its argument that some portion of Plaintiff’s claims are time-barred at the summary judgment stage.”
With regard to the court’s decision that plaintiffs “have adequately pleaded a claim” that Roundup’s label is false or misleading under the DCCPPA, the Opinion states: “Roundup supposedly targets an enzyme that is not found in people or animals, but that enzyme is, in fact, found in their gut bacteria.” Moreover, the Court notes that “even if the statement on Roundup’s label is not ‘literally false,’ Plaintiffs have also alleged that it is also misleading.” For these reasons, the Opinion states, the Court “cannot conclude that ‘no reasonable person would be deceived’ by the Roundup label, such that dismissal of Plaintiffs’ claims would be appropriate.”
Perhaps of most interest is the Opinion’s discussion of the preemption claim in light of the fact that the claims at issue are claims approved on multiple occasions by the U.S. Environmental Protection Agency (EPA) as part of its approval of the label. The Opinion states that “Plaintiffs’ claims are not preempted because the DCCPPA, as it relates to pesticide labels, does not impose a broader or different obligation than FIFRA.” Rather, “[u]nder both statutes, false or misleading statements on a pesticide label are proscribed.” The Opinion cites the Supreme Court case Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) in stating that “the question is not whether the statute reaches conduct beyond such labeling,” but “whether the statute ‘impose[s] a labeling requirement that diverges from those set out in FIFRA and its implementing regulations’” (emphasis in original). Moreover, the Opinion finds that a request for declaratory relief is not “functionally a requirement that the company change its label.” Instead, the Opinion distinguishes between the declaration that plaintiffs seek, that Monsanto’s label violates the DCCPPA, and an injunction stating that the declaratory relief requested “would not require Monsanto to change its label, even though it might well ‘induce’ it to do so” (emphasis in original). The Court found that for this reason the requested relief is not preempted by FIFRA.
Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.
By Lisa M. Campbell and Carla N. Hutton
On April 10, 2018, Bergeson & Campbell, P.C. (B&C®) held a complimentary webinar, “FIFRA Hot Topics.” Co-hosted with Bloomberg BNA, the webinar featured Richard P. Keigwin, Jr., Director, Office of Pesticide Programs (OPP), Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA); Daniella Taveau, former International Trade Negotiator for EPA and now Regulatory and Global Trade Strategist, King & Spalding; and William L. Jordan, former senior toxics lawyer with EPA’s OPP and Office of General Counsel. The timely and fascinating conversation was augmented by B&C’s Senior Government Affairs Consultant, James V. Aidala, and moderated by Lisa M. Campbell, Partner, B&C. More information about the webinar, including instructions on downloading a recording and related materials, is available on our Regulatory Developments page.
By Lisa M. Campbell and Heather F. Collins, M.S.
On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1). Notice of Availability issued on March 21, 2018. 83 Fed. Reg. 12385. The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.” It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States. Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.
PR Notice 2018-1:
- Clarifies that the USDA’s most recent Census of Agriculture, conducted every five years by the USDA’s National Agricultural Statistics Service (NASS), is the appropriate source for data on acreage or crops grown in the U.S. to establish a minor use under the acreage definition in FIFRA 2(ll)(1);
- Revises and provides guidance to registrants concerning the method used by EPA for evaluating “sufficient economic incentive” under FIFRA Section 2(ll)(2); and
- Explains how qualitative information may be used to inform the quantitative analysis and interpret the results.
Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2. EPA states PR Notice 2018-1 supersedes PR Notice 97-2. EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.” EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.” For this reason, “EPA revised the method to determine an economic minor use.”
PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use. The criteria in PR Notice 97-2 only applied to conventional pesticides.
EPA states the rationale for revising the PR Notice to consist of the following:
- EPA has decided to revise the policy on determining minor use.
- First, PRN 97-2 is outdated regarding the crops that would not meet the acreage definition of a minor use under FIFRA section 2(ll)(1). PRN 97-2 contained a fixed list of crops that were grown on more than 300,000 acres in 1997, but cropping patterns change over time and the list of crops provided in PRN 97-2 is no longer accurate.
- Second, the method in PRN 97-2 does not accurately reflect economic incentive to register pesticides. Gross revenue is not an appropriate measure for estimating returns on an investment; since it does not account for production and distribution costs, it overstates the returns to the investment. However, revenue from a single year understates the time period when a firm would receive a return on an investment. Finally, gross revenue at full market potential does not account for the difference in timing between costs of registration and future returns. Costs are likely to be incurred at the beginning of registration, whereas revenues will occur over multiple, future years.
- Third, PRN 97-2 applies only to registration actions on conventional pesticides. The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants). The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.
Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process. It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:
- Extension of exclusive use of data under FIFRA Section 3(c)(1)(F)(ii); and
- Qualifying for an exemption from the fee or waiver of a portion of the registration service fee for an application for minor uses of a pesticide under FIFRA Section 33(b)(7)(D).
More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.