By James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson
On January 11, 2022, the U.S. Environmental Protection Agency (EPA) announced it is implementing a new policy regarding the evaluation and registration of new conventional pesticide active ingredients (AI) to comply further with the Endangered Species Act (ESA) (ESA Policy). EPA also issued a Question and Answer document regarding its ESA Policy. Effective immediately, EPA will evaluate the potential effects of new conventional AIs on federally threatened or listed endangered species (Listed Species) and their designated critical habitats, and initiate ESA consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) if necessary before EPA registers any new conventional AIs. The new ESA Policy will apply to all new conventional AI applications, including applications already submitted to EPA but not yet completed.
Under the ESA, EPA must ensure that its actions are not likely to result in jeopardy or adverse modification of designated critical habitat or Listed Species. To determine whether the action may affect Listed Species and their designated critical habitats, EPA makes one of three types of species-specific effects determinations: No Effect (NE), Not Likely to Adversely Affect (NLAA), or Likely to Adversely Affect (LAA). EPA states that historically it did not “consistently assess the potential effects of conventional pesticides on listed species when registering new AIs.” This, EPA states, “resulted in insufficient protections from new AIs for listed species, as well as resource-intensive litigation against EPA for registering new AIs prior to assessing potential effects on listed species.” EPA believes its new ESA Policy should assist in reducing these types of cases against EPA and improve the legal defensibility of new AIs.
EPA states that under the new ESA Policy, if EPA makes an LAA determination through its analyses of a new conventional pesticide AI, EPA will initiate formal consultation with the Services before granting a new AI registration. As part of its analysis and under its existing authorities, EPA will consider the likelihood that the registration action may jeopardize the continued existence of Listed Species or adversely modify their designated critical habitat and provide its findings to the Services. To determine or predict the potential effects of a pesticide on these species and habitats, EPA will use appropriate ecological assessment principles and apply what it has learned from past effects determinations and the Services’ biological opinions. EPA states it is determining whether any new information would be useful for assessing the potential impacts on Listed Species from a new AI, and it will specifically contact registrants that have a new Al application currently under consideration to discuss whether additional information is necessary for EPA’s ESA assessment for the new conventional AI.
If EPA determines that jeopardy or adverse modification is likely for a designated critical habitat or Listed Species, it will only make a registration decision on the new conventional AI after requiring registrants to implement mitigation measures that EPA determines would likely prevent such jeopardy or adverse modification. If EPA finds that a new AI is likely to affect adversely a Listed Species or its critical habitat, but that a jeopardy or adverse modification is not likely, it may nonetheless require registrants to include mitigation measures as part of their registration and product labeling to minimize the potential effects of incidental take to Listed Species that could result from use of a pesticide. In both situations, formal consultation with the Services would still be necessary, as EPA states final jeopardy or adverse modification determinations must be made by the Services. Regarding timeframes, EPA states in the Q&A that it “strives to complete new AI applications within PRIA timelines,” but will work with affected registrations to “renegotiate” PRIA deadlines if EPA believes additional time will be needed under the ESA Policy.
EPA states that it has prioritized conventional pesticide AIs but that it is continuing to explore applying these new ESA approaches to new biopesticide AIs and new antimicrobial AIs. EPA also is developing a comprehensive strategy to address ESA for pesticides at all stages of the registration process. EPA is currently developing a detailed work plan to outline additional improvements to further its compliance with the ESA, including steps to implement protections for high-risk species more efficiently, provide growers with more flexible mitigation measures, and increase stakeholder engagement.
This announcement represents the next attempt by the Office of Pesticide Programs (OPP) to comply with ESA requirements in a way that, as the ESA Policy points out, will be more legally defensible while continuing its work to review and approve new pesticide AIs. In recent years, EPA has tried various arguments, mostly futile, to convince courts that past attempts to comply with ESA were sufficient.
This ESA Policy hints at important changes both in EPA’s past rhetoric regarding compliance and possible changes to the ways ESA assessments have been conducted in the past. On the record, EPA has maintained it complied with ESA when registering a new product. The courts have found this claim unsupported and almost always agreed with groups that challenged that claim. There have been a few exceptions where EPA, while not entirely resolving ESA concerns, had more “up front” consideration of ESA issues. Such earlier attention to resolving any ESA concerns, however, can add significantly to the time spent and data requirements to evaluate and address ESA issues.
Any relatively successful cases over past years complement the renewed and explicit commitment by the Biden Administration with the ESA Policy to attempt to resolve the long-standing problem of establishing a registration process that better addresses ESA issues with, among other things, improved coordination between EPA procedures and the review process (and conclusions) of the Services. Past Administrations have expressed similar rhetoric, but so far, many have tried, and all have failed.
In various forums, EPA has dryly described the efforts generally as -- “EPA is currently developing a detailed work plan to outline additional improvements to further the Agency’s compliance with the ESA.” More importantly, perhaps, and new to the mix is that EPA now has a senior political appointee (Jake Li as Deputy Assistant Administrator of OCSPP) especially tasked to lead efforts regarding the ESA-FIFRA integration process.
For applicants and registrants of new conventional AIs, these revised efforts may lead to some delays in the current expected timeframes to “work out” ESA concerns earlier in the process. And importantly, EPA’s ESA Policy describes how new approvals will include more “up front” mitigation measures designed to protect threatened and endangered species to a sufficient, or at least better, degree -- which appears to be a key change designed to reduce the litigation risks that have dogged new registration decisions in recent years.
By Heather F. Collins, M.S. and Barbara A. Christianson
On October 1, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the that fees under the Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) were increased by five percent for pesticide applications received on or after October 1, 2019. The five percent increase is on fee amounts established by Public Law 116-8, which became effective on March 8, 2019. The revised fees will remain in effect until September 30, 2021.
The fee schedule provided in PRIA 4 identifies the registration service fees and decision times organized according to the organizational units of the Office of Pesticide Programs (OPP) within EPA. EPA presents the schedules as 19 tables, organized by OPP Division and by type of application or pesticide subject to the fee, and lists the registration service fee for actions received in fiscal years 2020 and 2021. Applicants must submit fee payments at the time of application. EPA will reject any application that does not contain evidence that the PRIA 4 fee has been paid.
The revised fee schedule for PRIA 4 fiscal years 2020 and 2021 is available on EPA’s website. More information on the PRIA 4 legislation is available on our blog under key word PRIA.
By Lisa M. Campbell and Timothy D. Backstrom
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site. The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC).
EPA states in the notice that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these 10 applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve "a changed use pattern." Instead, EPA states that it has decided to provide an opportunity to comment in this instance "because of the potential significant interest from the public" and to be "completely transparent about these applications." EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future.
EPA also states that the products with requested label amendments contain active ingredients for which EPA "has previously determined the residues will be safe under any reasonably foreseeable circumstances." Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities.
The 10 products for which EPA has received an application to add hemp are:
- Debug Turbo, EPA Registration No. 70310-5, active ingredients: azadirachtin and neem oil;
- Debug Optimo, EPA Registration No. 70310-7, active ingredients: azadirachtin and neem oil;
- Debug Trés, EPA Registration No. 70310-8, active ingredients: azadirachtin and neem oil;
- Debug-ON, EPA Registration No. 70310-11, active ingredient: neem oil;
- REGALIA Bioprotectant Concentrate, EPA Registration No. 84059-3, active ingredient: extract of Reynoutria sachalinensis;
- MBI-110 EP, EPA Registration No. 84059-28, active ingredient: Bacillus amyloliquefaciens strain F727;
- GH CMT, EPA Registration No. 91865-1, active ingredients: soybean oil, garlic, oil, and capsicum oleoresin extract;
- GH MPMT, EPA Registration No. 91865-2, active ingredient: potassium salts of fatty acids;
- GH DNMT, EPA Registration No. 91865-3, active ingredient: Bacillus amyloliquefaciens strain D747; and
- GH NAMT, EPA Registration No. 91865-4, active ingredient: azadirachtin.
Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season.
Although the Federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every State has changed its laws to conform to the new classification. EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky. Senator Rand Paul of Kentucky has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use.
As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop. Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits. This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can applied to hemp. As EPA has noted, the active ingredients in the 10 products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue.
Comments are due on or before September 23, 2019. The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2019-0369.
By Lisa M. Campbell and Lisa R. Burchi
On May 21, 2019, the U.S. Environmental Protection Agency (EPA) announced that “to increase transparency and ensure information is easily accessible,” it has created a new web-based table of the most recent pesticide registration review actions that contains a list of the registration review actions EPA has taken over the current fiscal year, including the chemical name, docket number, and public comment period when applicable. EPA will update the table each time a registration review action is published. Stakeholders and the public can now quickly locate and sort through the following information for each active ingredient with a recent registration review action:
- The docket number (with a direct link to the docket);
- Comment period deadline (if applicable);
- Case number;
- Designated division;
- Registration review action type; and
- Contact information for the chemical review manager.
The new table also provides direct links to dockets, making it easy to access supporting information and documents related to a pesticide’s registration review. EPA states that it plans to update continuously this table as new registration review actions occur.
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.
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By Margaret R. Graham
On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN):
- PRN 2017-1: Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels. It addresses “end-use herbicide, fungicide/bactericide, or insecticide/acaricide products that are intended mainly for agricultural and certain non-crop land areas under commercial or government-sponsored pest management,” and applies in particular to “all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of way, and pest management along roadways.”
- PRN 2017-2: Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship, which “communicates the agency's approach to address herbicide-resistant weeds.” It is “germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.” It also applies to “non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.”
These final PRNs reflect consideration of public comments submitted on the draft PRNs. Also available in the dockets are EPA’s responses to comments on the draft PRNs: Response to Comments on PRN 2017-1; and Response to Comments on PRN 2017-2. EPA states that “PRNs are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and to provide guidance to pesticide registrants and OPP personnel.”
More information on PRNs is available on our blog under key phrase pesticide registration notice.
By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson
On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.
PR Notices are issued by the Office of Pesticide Programs (OPP). EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PRN 98-10 in a table. Those changes include:
In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:
- F. Product Composition: (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification. Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
- F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume. Under the proposed PR Notice, these terms were removed.
Minor Formulation Amendments
- A. Minor Formulation Amendments: (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
- A. Minor Formulation Amendments: (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review.
- A. Minor Formulation Amendments: (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product.
- Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
- Pet spot-on products;
- Change to an active ingredient source;
- Change to nominal concentration of the active ingredient; or
- Addition of new or additional Confidential Statements of Formula (CSF).
EPA Procedures to Review Notifications
Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same.
One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.
Registrants Submitting Minor Formulation Amendments
Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs. EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.
Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.
Registrants should review the draft PR Notice carefully, as it includes important changes. For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe. As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification. Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market. Comments on issues of concern should be considered.
By Lisa M. Campbell and Lisa R. Burchi
The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016. A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use,” is discussed in our blog item EPA Solicits Comments on Updated Method for Establishing Economic Minor Use.
In the notice extending the comment period, EPA noted that the current comment period is “one of the busiest times of year for pest control experts” and provides an extension that “will allow them extra time to complete their review and comment on the PR Notice.”
There is one comment that already has been submitted by the U.S. Department of Agriculture (USDA), which EPA stated it consulted prior to releasing the draft PRN 2016-X. In its comments, USDA states:
- Regarding acreage cutoffs, USDA supports EPA’s use of acreage estimates from the USDA Agricultural Census, as it is the “most reliable and comprehensive public source for such information in the country.”
- Regarding EPA’s proposal to apply a seven percent discount rate, USDA recommends that EPA be “open to using supplemental information in determining whether or not an alternative discount rate should be considered.”
- Regarding EPA’s proposal that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue, USDA requests that EPA provide its rationale as to why this range was chosen. USDA states: “Although USDA understands that EPA is attempting to reveal the ratio of gross revenue to cost associated with the minor use rather than across an entire company, one could assume that a rational company would not pursue registering a minor use if the ratio of costs to gross revenue was exceedingly higher than the average standard ratio for the company. Qualitative information, as suggested by EPA, could then be used to further refine the estimate for this ratio.”
- Regarding EPA’s proposal to use study cost estimates provided by independent laboratories, USDA notes there are instances where data can be significantly more expensive than what would be expected generally and, thus, recommends that EPA “be open to additional, verifiable data a registrant wishes to submit that may indicate that its cost of data generation differs from EPA's standard estimates.” USDA also suggests that EPA “consider making the cost estimates it is using for individual tests available publically to aid registrants in determining whether or not they need to submit alternative incurred costs for studies they have conducted.”
By Lisa M. Campbell, Lisa R. Burchi and Timothy D. Backstrom
On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-73353, the U.S. Environmental Protection Agency (Respondent; EPA) filed a motion for voluntary vacatur and remand of EPA’s registration, as amended, of Dow AgroSciences LLC’s (Dow) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants.
This case commenced in October 2014 when the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed petitions for review challenging EPA’s decision to register Enlist Duo, a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D. Petitioners argued, in part, that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.
EPA’s motion reverses EPA previous position that Dow’s application for Enlist Duo satisfied the requirements for issuance of an unconditional registration under FIFRA Section 3(c)(5). EPA states that it is seeking a voluntary remand to reconsider the Enlist Duo registration in light of new information regarding potential synergistic effects referred to as “synergistic herbicidal weed control” between the two active ingredients 2,4-D and glyphosate contained in Enlist Duo on non-target plants. Specifically, EPA is in the process of evaluating information submitted to it by DAS on November 9, 2015, in response to EPA’s request for all available information related to synergistic effects. EPA asserts that none of this information was submitted to EPA prior to EPA’s issuance of the Enlist Duo registration.
EPA states that the claimed synergism could affect EPA’s “assessment of drift reduction measures for avoiding impacts to non-target organisms, including those listed as endangered.” EPA also states that it “cannot be sure, without a full analysis of the new information, that the current registration does not cause unreasonable effects to the environment, which is a requirement of the registration standard under FIFRA” and that its initial review “indicates that the 30-foot buffer included in the registration may not be adequate.”
DAS has until December 7, 2015, to file its response before the court will consider EPA’s motion to remand the registration. Although it has not completed its assessment, EPA states that if the court vacates the Enlist Duo registration, EPA will issue a cancellation order to regulate the sale, distribution, and use of existing stocks of Enlist Duo pursuant to FIFRA. This case is being considered for the March 2016 oral argument calendar but the exact date of oral argument has not been determined at this time. More information regarding this case is available in our blog items Environmental Groups File Opening Briefs Challenging EPA’s Decision to Register Enlist Duo and Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.
EPA’s request for remand with vacatur rather than a remand without vacatur is a severe action. EPA could have chosen to seek remand without requesting that the registration be vacated, and then demanded prompt revision of the buffer zone that EPA now believes may be inadequate to protect non-target plants from synergistic effects. EPA may have decided to send a message that there will be serious consequences when an applicant fails to submit all of the data in its possession that may be pertinent to EPA’s assessment of the statutory criteria for registration. In any case, Dow reportedly has stated that it does “not expect these issues to result in the long-term cancellation of the Enlist Duo product registration” and that Dow will “continue to prepare for commercial sales of Enlist Duo for the 2016 growing season with enthusiastic grower adoption."