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 Barbara Christianson

On June 26, 2019, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment deadline on its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 30112.  EPA states that it is extending the comment deadline “after receiving public comments requesting additional time to review the Glyphosate Proposed Interim Registration Review Decision and supporting materials.”

The deadline to submit comments was extended from July 5, 2019, to September 3, 2019.  The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.

More information on glyphosate issues is available on our blog.


 

By Lisa M. Campbell and Carla N. Hutton

On June 14, 2019, Canada’s Pest Management Regulatory Agency (PMRA) began a public consultation on Discussion Document DIS2019-01, “Consultation on Inspecting Confidential Test Data for Post-market Reviews in the Reading Room.”  Before a pesticide can be registered for use in Canada, PMRA states that it reviews the available scientific test data to determine whether there are concerns for human health or safety, or the environment, when the product is used according to the label.  Some of the data reviewed by the PMRA scientists include confidential test data on:

  • Toxicology related to human health;
  • Bystander and occupational exposure;
  • Food residue trials;
  • Environmental toxicology and fate;
  • Product efficacy, crop tolerance, and benefits of the product; and
  • Other scientific data or studies submitted to, or considered by the PMRA.

According to PMRA, the purpose of the consultation document is to seek input on a proposal to expand access to confidential test data by inviting interested members of the public to inspect these data at the proposed decision stage for post-market reviews such as re-evaluations and special reviews.  Currently, PMRA prepares confidential test data for public inspection only after it makes a final decision.  PMRA proposes to allow interested parties seeking to understand the scientific basis for a proposed re-evaluation or special review decision to inspect the data used by PMRA earlier in the process.  PMRA states that by viewing these data earlier, comments submitted through the existing consultation process may be more well-informed.

PMRA notes that the proposed change would still require the inspection of confidential test data to take place at its National Head Office in Ottawa, Ontario.  PMRA states that it is aware that this could be burdensome and is investigating alternative approaches for the future that may allow the inspection of data through other means, such as satellite reading rooms or secure portals.  Publication of the consultation document began a 60-day comment period.


 

By Lisa M. Campbell and Lisa R. Burchi

On May 30, 2019, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order in National Family Farm Coalition v. EPA, No. 17-70810 (filed Mar. 21, 2017) regarding the scope of its review of a petition challenging a 2017 U.S. Environmental Protection Agency (EPA) Notice of Pesticide Registration.  This 2017 order addresses Dow AgroSciences LLC’s Enlist Duo product.  The Petitioners include the National Family Farm Coalition and the Natural Resources Defense Council.

The May 30, 2019, order addresses whether the court could review two prior EPA orders, one issued in 2014 and one in 2015, regarding the registration of Enlist Duo.  Those 2014 and 2015 EPA orders had also been challenged in court, and subsequently remanded to EPA to consider additional information.  Following EPA’s consideration of this additional information, EPA increased the allowed use sites for the Enlist Duo registration to include cotton and increased the number of states authorized to use Enlist Duo from 15 to 34 states.

The Ninth Circuit’s May 30, 2019, order finds that the 2017 order “reissues the original Enlist Duo registration and amendment addressed in the 2014 and 2015 orders, thus making the full registration of Enlist Duo for GE corn, soybean and cotton for use in 34 states subject to [its] review.”  The court based its decision on the language of EPA’s 2017 order and EPA’s Final Registration Decision.  The court found persuasive, for example, that EPA’s 2017 order states that it “supercedes” EPA’s 2014 order, which the court stated is “consistent with our determination that the 2014 order previously remanded to EPA has now been finalized.”  Since EPA identified its 2017 order as final and had characterized its 2014 and 2015 orders as having an incomplete record, the court stated that it will “review the 2017 order on the combined records of the 2014, 2015 and 2017 orders, all of which is incorporated into the 2017 order’s record.”

The court further noted that EPA’s “2017 order also purports to extend the 2014 registration’s (and that of the 2015 amendment) initial 2020 expiration date by two years.”  Since the court found that nothing “suggests that this term is specific to the new uses on GE cotton in 34 states or GE corn and soybean in the additional 19 states,” the court stated that the 2017 EPA order could not have been limited to adding only these post-2015 uses as EPA had asserted. 

Following this determination, the Ninth Circuit stated that “submission of this case is deferred” pending additional briefing to address “all challenges to the initial registration (2014 order) and the original amendment (2015 order), as that registration and amendment has been reissued in the 2017 order -- including challenges to all supporting documentation” and “what relief [it] should provide if Petitioners’ claims are successful, ‘in whole or in part.’”  The timing for such briefing is as follows:

  • Counsel for each Petitioner is directed to file a supplemental brief of 7,000 words or less within 60 days of the date of the order (by July 30, 2019);
  • Counsel for Respondent and Intervenor are directed to file a responsive brief of 7,000 words or less within 60 days from the date of filing of Petitioners’ briefs; and
  • Petitioners may each file reply briefs not to exceed 3,500 words within 30 days from the date of the filing of Respondent’s brief. 

 

By Lisa M. Campbell and Lisa R. Burchi

On May 29, 2019, the California Department of Pesticide Regulation (DPR) released California Notice 2019-05: Changes to California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2019-05), which updates the guidance in California Notice 2018-06: California-like Conditions for Terrestrial Field Dissipation Studies (Notice 2018-06).  

Notice 2018-06, issued in January of 2018, provided to applicants for California registration of new agricultural use pesticides guidance specifically related to the requirement to submit at least one terrestrial field dissipation (TFD) study conducted under “California or similar environmental use conditions.”  DPR states it is revising this guidance based on comments from the Western Plant Health Association.  The updated guidance is summarized below.

Notice 2019-05 also extends the effective date to July 1, 2020; for applications submitted July 1, 2020, or later, DPR states it will consider a TFD study to have been conducted under “California or similar environmental use conditions” if the study was conducted within or outside of California in accordance with U.S. Environmental Protection Agency (EPA) study guidelines and under certain criteria, as provided below.

1. Timing:  April 1 shall be the earliest study start date and September 30 shall be the latest start date. This timing ensures a potential leaching environment with respect to the amount of percolating water produced relative to evapotranspiration (ET).

2. Soil:

  • The study is conducted in a coarse-texture soil in accordance with the U.S. Department of Agriculture (USDA) soil textural classification (see Table 1).  The minimum depth-weighted average sand content for representative samples taken across the test site should be no less than 68 percent as measured within the top 30 cm of soil.  The allowable minimum soil sand content that is included in the average is 61 percent.
  • The soils used for the study do not have a restrictive layer to the movement of water as indicated within the soil profile, such as a hardpan, compacted layer, or an abrupt change in texture.
  • The maximum depth-weighted average organic matter content for representative samples taken across the test site should be no greater than 1.4 percent as measured within the top 30 cm of soil.  The allowable maximum organic matter content that is included in the average is 1.6 percent.
  • Studies shall be conducted on bare soil plots.  Exceptions are possible for studies conducted in the presence of a crop or turf with sufficient justification.

3. Water Inputs:

  • Water applications to the study site are sufficient to create levels of percolating water that reflect the potential amount lost from crop irrigations (i.e., 160 percent of ET).  Approximately 60 percent of applied water is available for movement below the coring depth, which would equate to water applications of approximately 160 percent of ET.  Therefore, a scheduled water input would approximate the cumulative daily ET since the previous water input multiplied by an excess demand factor of 1.6.  For bare soil plots, ET can represent reference ET or, if preferred, soil evaporation when calculated using a scientifically defensible methodology. These water inputs supersede those in EPA’s guidance document for TFD studies.
  • The initial water application to the study site occurs within one week of chemical application.  Subsequent water applications shall be at seven-day intervals or less for the duration of the study.
  • Water inputs from rain are subtracted from scheduled water input amounts.

DPR states that if a TFD study submitted to DPR to meet the statutory requirement of having been conducted under “California or similar environmental use conditions” does not meet one or more of the above criteria, the applicant may include in its submission a justification for any different criteria to avoid a determination that the study is unacceptable.

Table 1.  USDA textural classes1 of soils acceptable for TFD studies

1Based on USDA particle-size classification.


 

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, Lisa R. Burchi, and James V. Aidala

On May 6, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing its Proposed Interim Registration Review Decision (PID) for glyphosate acid and its various salt forms.  84 Fed. Reg. 19782.  In the PID, EPA states that it “did not identify any human health risks from exposure to any use of glyphosate” but did identify “potential risk to mammals and birds” within the application area or areas near the application area and “potential risk to terrestrial and aquatic plants from off-site spray drift, consistent with glyphosate’s use as a herbicide.”  Even with these potential risks, the PID states that “EPA concludes that the benefits outweigh the potential ecological risks when glyphosate is used according to label directions” and proposes certain risk mitigation strategies, including:

  • “To reduce off-site spray drift to non-target organisms, the EPA is proposing certain spray drift management measures” with specific spray drift mitigation language to be included on all glyphosate product labels for products applied by liquid spray application;
  • “To preserve glyphosate as a viable tool for growers and combat weed resistance, the EPA is … proposing that herbicide resistance management language be added to all glyphosate labels” and to require measures “for the pesticide registrants to provide growers and users with detailed information and recommendations to slow the development and spread of herbicide resistant weeds”;
  • Inclusion on labels of a non-target organism advisory statement to alert users of potential impact to non-target organisms; and
  • “EPA is also proposing certain labeling clean-up/consistency efforts to bring all glyphosate labels up to modern standards.”

EPA states that these measures were discussed with glyphosate registrants, who do not oppose the proposed risk mitigation measures outlined in the PID.

The public can submit comments on EPA’s proposed decision at www.regulations.gov in Docket Number EPA-HQ-OPP-2009-0361.  Public comments are due by July 5, 2019.  In addition to the PID, EPA is also posting to the glyphosate docket EPA’s response to comments on glyphosate’s usage and benefits (dated April 18, 2019), EPA’s response to comments on the human health risk assessment (dated April 23, 2018), and EPA’s response to comments on the preliminary ecological risk assessment (dated November 21, 2018). 

This PID was issued shortly after the Agency for Toxic Substances and Disease Registry’s announcement on April 8, 2019, of the opening of a docket on the draft toxicological profile for glyphosate.  84 Fed. Reg. 13922.  ATSDR seeks comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile.  Comments are due by July 8, 2019.

Commentary

EPA’s PID and related documents, along with ATSDR’s draft profile and the peer review which will follow, can be expected to become part of the larger debate about the potential risks of glyphosate.  In 2017, EPA evaluated the carcinogenic risk of glyphosate, and released its draft human health and ecological risk assessments.  See our December 19, 2017, blog item "EPA Releases Draft Human Health and Ecological Risk Assessments for Glyphosate for Public Comment" for more information. 

EPA’s PID is interesting not only for the conclusions EPA reached following its review of data submitted by registrants in response to a data call-in (DCI) and following the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel’s (SAP) meeting to consider and review scientific issues related to EPA’s evaluation of the carcinogenic potential of glyphosate, but for the issues that remain to be addressed.  Notably, EPA states that it has not considered the petition filed on September 27, 2018, to reduce glyphosate’s tolerance because the petition was filed after the comment period for the human health and ecological risk assessments closed.  Instead, EPA plans to post the petition in the glyphosate docket and address the petition concurrently with the development of the Interim Registration Review Decision.

In addition, EPA has not in the PID or related documents addressed issues regarding its Endangered Species Act (ESA) assessment or its Endocrine Disruptor Screening Program (EDSP) activities.  EPA states it intends to complete an assessment of risk to ESA-listed species prior to completing its final registration review decision for glyphosate, and that it also will make an EDSP determination under Federal Food, Drug, and Cosmetic Act (FFDCA) Section 408(p) before completing its registration review.  EPA also notes that it continues to evaluate risks to pollinators, and that if it determines “that additional pollinator exposure and effects data are necessary to help make a final registration review decision for glyphosate, then the EPA will issue a DCI to obtain these data.”  Although there are significant areas that remain to be resolved, EPA issued the PID “so that it can (1) move forward with aspects of the registration review case that are complete and (2) implement interim risk mitigation.”

More information on glyphosate issues is available on our blog.


 

By Sheryl Lindros Dolan and James V. Aidala

The Appropriations Bill that is expected to be signed into law on February 15, 2019, provides funding for the rest of Fiscal Year (FY) 2019 and averts another federal government shutdown.  It does not, however, include either an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or Reauthorization, widely referred to as PRIA 4.  This omission was a surprise to industry and to the U.S. Environmental Protection Agency (EPA).  On February 13, 2019, the Senate introduced a stand-alone PRIA 4 bill (S. 483).  Acting swiftly, the Senate passed the bill on February 14, 2019, by unanimous consent.  S. 483 directly references H.R. 1029, the Pesticide Registration Enhancement Act of 2017, from the last Congress, with amendments passed by the Senate on June 28, 2018.  

S. 483 has moved to the House, where the timing of a vote currently is unclear.  The House will go into a week-long recess after today.  It is possible that the bill will not further progress until the House reconvenes on February 25, 2019. 

The effect on EPA and the regulated community during this transition is also unclear.  Currently, EPA is sorting out applications and PRIA deadlines along with workload planning in the aftermath of the recently concluded federal government shutdown.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides for a reduction in applicable fees if PRIA is not reauthorized, but it is unclear if applications submitted during the transition will be assigned a PRIA review date.  If PRIA 4 is passed, we expect that the fee provisions will be retroactive and that EPA will send invoices to applicants for submissions made during the transition period for the difference between what was paid and the new PRIA 4 fee. 

More information on these topics is available in our blog items "Federal Budget Deal Negotiations Fail to Advance PRIA Reauthorization" and "Continuing Resolution to Re-open the Government Includes PRIA Extension."


 

By James V. Aidala

The short-term continuing resolution (CR) includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) through the duration of the funding measure, February 15, 2019.  This was expected, and is welcome news to registrants who have delayed submittal of registration applications due to the shutdown.

The status of applications submitted during the shutdown period is uncertain at best.  As described in our earlier blog item Registrants Face PRIA and Shutdown Issues, registrants were advised to not submit applications during the shutdown as the U.S. Environmental Protection Agency (EPA) has previously indicated that applications submitted during the shutdown would not be subject to any PRIA deadline.  During this period of budget battles and shutdown uncertainty, it would appear to be prudent to ensure that any applications for registration are submitted while EPA (and PRIA) are operational under appropriated funding.

While this is good news, the uncertainty surrounding the possibility of another shutdown at the end of this period not only makes planning difficult for registrants, it also creates workload management problems at EPA to deal with backlogs and unpredictable resources for processing pending and new applications.  EPA will have to clarify what the extended shutdown period means for processing times and priorities.  As of today, EPA is still literally sorting out applications and PRIA deadlines along with workload planning to determine how best to proceed.

Stay tuned …


 

By Lisa M. Campbell and Timothy D. Backstrom

On August 9, 2018, the majority of a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by the U.S. Environmental Protection Agency (EPA) that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.”  A separate dissent stated that the court should have dismissed the case for lack of jurisdiction.  Please see our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017.

EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because Section 408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1).The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.”In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order.

After concluding that the objections process is not jurisdictional in character, the majority next considered whether the petitioners should nonetheless be required to exhaust their administrative remedies by waiting until EPA responds to their objections before obtaining judicial review.Although FFDCA Section 408(g)(2)(C) requires EPA to rule on the objections “as soon as practicable,” EPA had taken no action for 13 months after the objections were filed.The majority concluded that the exhaustion requirement should be waived “in light of the strong individual interests against requiring exhaustion and weak institutional interests in favor of it.”

EPA did not specifically address the substantive merits of the 2017 order in its brief, and the majority found that EPA has consequently “forfeited any merits-based argument.”The 2017 order was issued in the context of an administrative record in which EPA has repeatedly determined that the FFDCA standard for maintenance of chlorpyrifos tolerances (“a reasonable certainty that no harm will result from aggregate exposure to the pesticide”) could not be met because of the risk of neurodevelopmental effects. The standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) incorporates this same FFDCA standard. Although the 2017 order stated that “the science addressing neurodevelopmental effects is unresolved,” it did nothing to alter these prior EPA determinations. The majority noted that EPA’s assertion that “significant uncertainty” remains regarding the health effects of chlorpyrifos being directly at odds with the “reasonably certainty” standard and “therefore mandates revoking the tolerance under [FFDCA Section 408(b)(2)(A)(i)].” The majority concluded that the possibility that future evidence may contradict EPA’s current determinations cannot justify continued inaction, and that the failure of EPA to proceed with the revocation of the tolerances and the cancellation of the registrations for chlorpyrifos “has now placed the agency in direct contravention of the FFDCA and FIFRA.”

Commentary

The court’s direct instruction requiring EPA to proceed promptly with revocation of all tolerances and cancellations of all registrations for chlorpyrifos represents an unusually aggressive judicial intervention in the administrative process.Nevertheless, this outcome must be viewed in the context of an eleven year history beginning with an administrative petition that requested the same relief, followed by a writ of mandamus in 2015 from the same court requiring EPA to make a prompt decision on the petition.Although substantial controversy remains concerning the correct interpretation of epidemiology studies with chlorpyrifos, it appears that the court believes that EPA has not taken any action that would support a change in EPA’s prior conclusion that these studies constitute evidence of potential neurodevelopmental effects in children at chlorpyrifos exposure levels below the threshold for acetylcholinesterase (AChE) inhibition. Had EPA’s 2017 denial of the administrative petition been accompanied by an amended risk assessment for chlorpyrifos which articulated a changed conclusion, the court may have been less likely to substitute its judgment for that of EPA.The court seemed to find that because the scientific assessments in the current administrative record could not support the “reasonable certainty” standard in the FFDCA, the conclusion it reached on the merits was unavoidable.

Please see our blog item “Oral Argument Held in Case Challenging EPA’s Denial of Petition to Revoke Chlorpyrifos Tolerances” for information on the oral argument that took place on July 9, 2018, and the briefing in this case.  Further information on the case proceedings is available on our blog under key word chlorpyrifos.


 

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.

 


 
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