Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Timothy D. Backstrom

Significant issues concerning the scope of the U.S. Environmental Protection Agency’s (EPA) authority to cancel conditional registrations are raised by recent events concerning flubendiamide products sold in the U.S. by BayerCrop Science LP (Bayer) under the trade name Belt.  Bayer announced on February 5, 2016, that it will not comply with EPA’s request that Bayer “voluntarily” cancel its registered flubendiamide products.  In a January 29, 2016, letter, EPA stated that flubendiamide and a  degradate compound are “mobile, stable/persistent, accumulate in soils, water columns and sediments and are toxic to aquatic invertebrates.”  Based primarily on EPA’s ecological risk assessment, EPA has determined “that the continued use of the currently registered flubendiamide products will result in unreasonable adverse effects on the environment.”  Bayer disagrees strongly with the EPA risk assessment, because Bayer believes it is based on overly conservative modeling estimates that cannot be reconciled with actual monitoring and environmental fate data for this pesticide.

Conditional registrations for pesticides containing flubendiamide were first granted by EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) in 2008.  As one condition of registration, EPA required Bayer to conduct specific environmental fate studies, which have now been submitted and reviewed.  EPA also adopted an initial expiration date for all registrations of flubendiamide products of July 31, 2013, which EPA later agreed to extend several times to allow time for further review and discussion of the submitted data.  The current dispute with Bayer involves a specific condition that EPA included in its preliminary acceptance letter for this active ingredient, which EPA contends obligates Bayer to request voluntary cancellation of the registrations now that EPA has made a finding of unreasonable adverse effects.  Bayer characterizes the condition in question as “unlawful,” and argues that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) before the registrations can be cancelled.

Commentary

Because Bayer has not submitted the “voluntary” cancellation requests demanded by EPA, EPA has stated that it will initiate the cancellation process for conditional registrations established by FIFRA Section 6(e).  Although this process affords Bayer an opportunity for an administrative hearing, the issues in a conditional registration hearing under FIFRA Section 6(e) are limited to “whether the registrant has initiated and pursued appropriate action to comply with the condition,” and the EPA determination concerning disposition of existing stocks.  Bayer argues that the condition as it was originally imposed by EPA was improper and denies statutory due process rights, and that EPA must afford Bayer a full adjudicatory hearing under FIFRA Section 6(b) rather than the limited hearing provided under FIFRA Section 6(e).

This dispute presents a variety of important legal questions, including what authority EPA has under FIFRA to impose time limitations or expiration dates for pesticide registrations, the rights a registrant has when it applies to amend or to renew a time-limited registration, and the nature of the conditions that EPA may lawfully impose for a conditional registration under FIFRA Section 3(c)(7).  The entire pesticide industry will be watching this matter with great interest.


 

By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On January 25, 2016, in a significant development in the case involving the continued registration of DowAgrosciences LLC’s (DowAgro) Enlist Duo product, the U.S. Court of Appeals for the Ninth Circuit in Case Nos. 14-73353, et al. (consolidated), denied the U.S. Environmental Protection Agency’s (EPA) motion for voluntary vacatur of the Enlist Duo registration, but granted EPA’s motion to remand its decision granting that registration.  DowAgro’s December 7, 2015, response to the EPA motions stated that DowAgro had “absolutely no problem with the requested remand to allow the agency to review that information, and hereby consents to such relief.”  DowAgro did oppose EPA’s request that the court vacate the registration, arguing that EPA was attempting to circumvent the normal cancellation process by having the court vacate the registration.  The case will now be remanded to EPA, and the Enlist Duo registration remains nominally in place.  The court’s order allows EPA to consider further action to vacate the registration, but this appears unlikely since DowAgro has previously indicated that it is willing to “stop sales of Enlist Duo, and to work out an appropriate agreement to that effect with the agency.”  After reviewing the new information concerning synergistic effects recently submitted by DowAgro, EPA will then make a new decision concerning the registration of Enlist Duo.

The court also denied DowAgro’s motion to strike the Natural Resources Defense Council’s (NRDC) December 17, 2015, reply in support of EPA’s motion for vacatur and remand.  DowAgro moved to strike NRDC’s reply because NRDC’s pleading was more of a “reply brief” than a response, and a “litigant has no right to file a ‘reply’ brief in support of a motion filed by another party.”  DowAgro’s motion to strike included a request to the court to grant it leave to respond to NRDC’s filing as well as a proposed response brief.  This procedural question is now moot because the court has acted on the EPA motions and the registration has been remanded to EPA.

More information on the recent case proceedings is available in our blog entry EPA Replies in Support of its Motion for Voluntary Vacatur and Remand.


 

By Sheryl L. Dolan and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently updated the electronic reporting option for pesticide establishments using the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section Seven Tracking System (SSTS), now referred to as the Enhanced Section Seven Tracking System (eSSTS).  On December 17, 21, 22 and 28, EPA will hold four public webinars to explain the Central Data Exchange (CDX) registration process for the eSSTS and demonstrate report submission using eSSTS.  EPA state that any establishments/authorized agents that used electronic reporting last year should automatically be registered to use the new eSSTS system.  CDX registration for eSSTS will be open after December 18, 2015; submitters will need to register to use the new system.  Pesticide establishments can use the CDX to submit EPA Form 3540-16 “Pesticide Report for Pesticide-Producing and Device-Producing Establishments,” the annual pesticide establishment report required under FIFRA Sections 7 and 17 to be submitted by all active domestic and foreign pesticide producing establishments, regardless of whether or not the establishment produced or distributed a pesticide, active ingredient, or device, by March 1 of each calendar year.

The first webinar on December 17, 2015, from 1:00 p.m. to 2:00 p.m. (EST) will explain the CDX registration process for the eSSTS.  Webinars 2, 3, and 4 will cover eSSTS training, but will all have the same information -- participants only need to attend one of these sessions.  Additional announcements and reporting instructions are posted on EPA’s Pesticide Establishment webpage.  More information on the specific trainings is listed below.  The links will not be active until the time of the webinar:

  1. CDX Registration Training for EPA's eSSTS, Thursday, December 17, 2015, 1:00 p.m. - 2:00 p.m. (EST) (Recorded):  An Overview of how to set up an EPA CDX account and set up a user role under EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTSCDX.
  2. EPA's eSSTS Industry User Training 1, Monday, December 21, 2015, 11:00 a.m. - 12:00 p.m. (EST) (Recorded):  Industry overview of EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing.
  3. EPA's eSSTS Industry User Training 2, Tuesday, December 22, 2015, 2:30 p.m. - 3:30 p.m. (EST):  Industry overview of EPA's (eSSTS), will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing2.
  4. EPA's eSSTS Industry User Training 3, Monday, December 28, 2015, 11:00 a.m. - 12:00 p.m. (EST):  Industry overview of EPA's eSSTS, will be available at http://epawebconferencing.acms.com/eSSTS_Industry_Testing3.

 

By Lisa R. Burchi and Lisa M. Campbell

On December 11, 2015, the California Department of Pesticide Regulation (DPR) issued California Notice 2015-13 that will require each person/company with products made from pesticide impregnated material that are sold into or within California under their own company name to register their product(s) as a pesticide.  Examples of pesticide impregnated materials affected by this Notice include apparel (e.g., jackets, shirts, hats, socks, pants, shorts) and non-apparel (e.g., bedding, tents, seat covers, chopping blocks, shower curtains, mouse pads) that make pesticidal claims.

The requirements will be effective November 1, 2016.

DPR currently registers a number of pesticide impregnated textiles bearing pesticidal claims.  DPR notes that while these products have been registered either by the manufacturer of the pesticide impregnated material or by the company impregnating the bolts of fabric or clothing, individual companies selling items made from pesticide impregnated textiles were not required to register the materials.  Instead, such companies were required only to obtain a pesticide broker’s license from DPR.  Under DPR’s new policy, “obtaining a broker’s license will no longer be sufficient for companies selling products under their own company label” (emphasis in original).  DPR states it is making this change to “facilitate tracking the use of these products in California and aid in the understanding of potential impacts on water quality and human health.”

With regard to registration requirements for pesticide impregnated products, DPR states that the number of registrations required will depend on several factors, including whether there are different pesticide active ingredients, different percentages of active ingredients, different types of fabrics, and/or different product uses.  DPR states that if the product contains the same type and percentage of active ingredient, one registration can be used to cover various types of pesticide impregnated apparel or non-apparel product use categories, but such determination will be made on a case-by-case basis.  As an example of products requiring separate registrations, DPR states: “If, for example, a person/company sells apparel impregnated with 0.52% of the active ingredient permethrin and other apparel impregnated with 0.48% of the active ingredient permethrin, two separate apparel registrations will be required because they contain different percentages of active ingredient.  The same holds true for a category of non-apparel products.”

Commentary

This Notice is a significant change in policy, and will impose potentially complicated and costly registration requirements on companies that sell pesticide impregnated material under their own company name but are not necessary familiar with pesticide registration requirements.  The number of new registrations that could be required could be substantial considering the number of factors DPR has specified that could trigger separate registrations.

Importantly, DPR clarifies that this Notice is not intended to change its general policy exempting from registration those products that satisfy the requirements to be a treated article.  DPR notes that for treated articles, the pesticide, and any related claims, must be related to protection of the article/substance itself.  These products are thus distinguishable from pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material. 


 

By Lisa M. Campbell and Timothy D. Backstrom

On December 7, 2015, in Case Nos. 14-1036 and 15-5168, the U.S. Court of Appeals for the D.C. Circuit issued an order denying the U.S. Environmental Protection Agency’s (EPA) motion for summary affirmance of an order issued by the D.C. District Court dismissing a complaint filed by Plaintiffs-Appellants Center for Biological Diversity, et al. (the Center) for lack of jurisdiction.  The Center’s complaint alleged that EPA violated the Endangered Species Act (ESA) and the Administrative Procedure Act (APA) by registering pesticides containing the new active ingredient cyantraniliprole without first consulting the U.S. Fish and Wildlife Service or the National Marine Fisheries Service.

EPA’s motion, filed on August 27, 2015, moved for summary affirmance of the district court’s order dismissing the complaint for lack of jurisdiction, stating that “the district court’s determination that exclusive jurisdiction over the Center’s claims lies in the courts of appeals under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act), Section 16(b), 7 U.S.C. § 136n(b), is so plainly correct that summary affirmance is warranted,” and “FIFRA’s special judicial review procedure applies to this case because the Center challenges EPA’s registration of cyantraniliprole, which is regulated by FIFRA.”  The Center argues that the district court has separate jurisdiction under the citizen suit provision of the ESA and/or that jurisdiction lies in the district court because there has been no public hearing under FIFRA Section 16(b).

The order denying the motion states that the “merits of the parties’ positions are not so clear as to warrant summary action.”  Opening briefs are due beginning January 19, 2016, and final briefs are due April 8, 2015.

Commentary

Although the general division of jurisdiction between U.S. district courts under FIFRA Section 16(a) and U.S. courts of appeal under FIFRA Section 16(b) has been construed differently, in general, since the 1986 D.C. Circuit decision Humane Society v. EPA, whether there has been a “public hearing” within the meaning of FIFRA Section 16(b) is determined based on the adequacy of the record for appellate review.  Since cyantraniliprole is a new active ingredient, EPA provided notice and an opportunity for comment under FIFRA Section 3(c)(4) before granting the registrations in question, so the record compiled by EPA appears to satisfy this test.  The decision of the D.C. Circuit to deny EPA’s motion for summary affirmance may reflect the stringent standard that must be met for such an action, rather than an indication of how the D.C. Circuit will ultimately rule on the merits. 


 

By Lisa M. CampbellLisa 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.

Commentary

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."


 

By Lisa M. Campbell and Timothy D. Backstrom

On November 12, 2015, the U.S. Environmental Protection Agency (EPA) issued a final cancellation order for all previously registered pesticide products containing the active ingredient sulfoxaflor, pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(1).  The registrations for the sulfoxaflor products in question were cancelled effective on November 12, 2015, by an order issued by the U.S. Court of Appeals for the Ninth Circuit that vacated the original EPA decision to grant unconditional registrations for sulfoxaflor.  More information on the court’s order is available in our blog item Ninth Circuit Vacates EPA's Unconditional Registration for the Neonicotinoid Pesticide Sulfoxaflor Based on Hazard to Bees.  The stated purposes of the “cancellation order” issued by EPA are:  (1) to allow distribution or sale of existing stocks of cancelled products for the purpose of return to the manufacturer, proper disposal, or lawful export; and (2) to allow existing stocks of cancelled products in the possession of end-users to be used provided such use is consistent in all respects with the previously-approved labeling for the product.

Cancellation of all sulfoxaflor registrations was an automatic consequence of the order vacating the registrations under FIFRA issued by the court on September 10, 2015, which took effect on November 12, 2015, with the formal issuance of the court’s mandate.  In response to the court’s decision, EPA stated: “While the Agency had determined that the benefits of sulfoxaflor outweighed that uncertain risk when mitigation measures were applied, EPA will not second-guess the Court's conclusion that the registrations at issue in the case were not supported by substantial evidence.”  According to EPA, this unusual mechanism for cancellation created an anomalous situation, where all distribution or sale to remove existing stocks of sulfoxaflor from channels of trade would be unlawful, but all existing stocks of the now unregistered products in the hands of users could be used without even observing the original label directions.  The “cancellation order” issued by EPA is intended to address these anomalies.  Rather than attempting to issue an order that would preclude all use, EPA stated: “While EPA agrees that there is uncertainty about sulfoxaflor's risks to bees, EPA does not believe use of existing stocks of sulfoxaflor would significantly impact bees.”

Commentary

In recent years, EPA has begun to characterize existing stocks orders issued under authority of FIFRA Section 6(a)(1) as “cancellation orders.”  This allows EPA to enforce the terms of its existing stocks’ determinations under FIFRA Section 12(a)(2)(K).  The order governing existing stocks of sulfoxaflor illustrates the potential utility of this approach.

The petitioners who obtained an order vacating EPA’s unconditional registration of sulfoxaflor are likely to be unhappy about the decision of EPA to allow some stocks of sulfoxaflor already in the hands of end-users to be used in accordance with label directions they deem inadequate to protect pollinators.  On the other hand, EPA has pointed out that the use of unregistered pesticides is not normally regulated at all under FIFRA, so the order issued by EPA allowing some use of existing stocks of sulfoxaflor assures that users are required to follow the existing product labeling until the stocks have been exhausted.  EPA also states that disposal of existing stocks already in the hands of end-users would be difficult and costly, and that EPA disfavors imposing “restrictions on existing stocks unless the holders of stocks are notified of the restrictions and are likely to comply with them.”   

 


 

By J. Brian Xu, M.D., Ph.D., DABT®  and Margaret R. Graham

Like so many other regulatory programs in China, pesticide regulations are changing.  At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring registrations for minor use crops.  In China, the vast majority of registrations are for major crops and only a few registrations have been issued for minor crops.  The Ministry of Agriculture also intends to prepare a "List of Pests and Pesticide Shortage for Minor Crops.”

Jun Yang, Director of the Efficacy Division, ICAMA, summarized recent trials and registrations of pesticides.  By the end of August 2015, China had a total of 33,029 registered pesticide products, an increase of 4,300 products when compared with 2013.  The total includes insecticides (12,812), fungicides (8,378), herbicides (7,807), and others including acaricides and plant growth regulators (4,032).  Insecticides were down 3 percent and fungicides and herbicides up 2 percent as a proportion of the total when compared with the total at the end of 2013.  The majority of registered products were issued for off-patent products.  The top ten active ingredients for which products were registered as of 2014 were reported to include:  the antifeedant, pymetrozine; the fungicides, azoxystrobin, tebuconazole and difenoconazole; the insecticides, thiamethoxam, emamectin-benzoate, avermectin and imidacloprid; and the herbicide, cyhalofop and glufosinate.  For more information on the report (which is available only in Mandarin), please e-mail Dr. Brian Xu at .(JavaScript must be enabled to view this email address).


 

By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala

In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids.  The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers.  The registrant Dow AgroSciences LLC (Dow) intervened in the action.

EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions.  EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies.  Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development.  The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.

EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012.  The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration.  EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment.  EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate.  The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures.  The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”  The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1  was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant.  The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000.  Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.

Commentary

This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds.  The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.”  While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment.  Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.

This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment.  The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients.  In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.


 

By Lisa M. Campbell, Sheryl L. Dolan, and Margaret R. Graham                                            

On September 1, 2015, the U.S. Environmental Protection Agency (EPA) announced the debut of a new electronic system for pesticide applications, the Pesticide Submission Portal.  According to EPA, this debut is the first step in a phased approach that ultimately will allow EPA to accept all pesticide applications electronically -- a move that will help modernize the pesticide registration process, increase operational efficiencies, and reduce paper waste.  EPA will continue to accept paper, CD and DVD applications, but encourages applicants to take advantage of what EPA states is the new, more efficient option.

The following types of applications will now be accepted through the Pesticide Submission Portal:

  • New pesticide active ingredients;
  • New pesticide products containing already-registered pesticide active ingredients;
  • Amendments to registered pesticide products;
  • Experimental use permits;
  • Inert ingredient requests;
  • Pre-application;
  • Petitions for food or feed tolerance, and
  • Distributor products.

The Portal is accessed through EPA’s Central Data Exchange (CDX) Network and requires user registration.  For registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools using EPA’s XML guidance, they may use the Portal and forego the courier costs to send to EPA. 

For electronic submissions, applicants do not need to submit multiple copies of any pieces of their application, as the requirement for multiple copies of data and five copies of draft labeling only applies to paper submissions.  Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated MRID numbers.

Additional information on the Portal, including a user guide and updated XML guidance, is available on EPA’s Electronic Submission for Pesticide Applications page.

Applicants will need to invest some time and resources up-front to register with CDX and become familiar with the electronic submission requirements.  With that investment, however, EPA’s secure portal should make the submission process more efficient for applicants.  Additionally, as EPA now scans all paper submissions upon receipt, electronic submissions should increase efficiencies and reduce the opportunity for error during EPA’s front-end processing -- always a good thing.


 
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