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, Lisa R. Burchi, and Barbara A. Christianson

On October 30, 2020, the U.S. Environmental Protection Agency (EPA) issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.”  According to EPA, the targeted changes improve the enforceability and workability of the AEZ requirements, decrease regulatory burdens for farmers, and maintain critical worker protections.  EPA also states the revisions made to the AEZ are consistent with the 2018 Pesticide Registration Improvement Extension Act of 2018 (PRIA 4).

The final AEZ requirements will go into effect on December 29, 2020.

EPA initially promulgated the WPS regulation in 1992 under EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorities to protect farm workers from pesticide exposures in production agriculture. According to EPA, “WPS is a uniform set of requirements for workers, handlers, and their employers that are generally applicable to all agricultural pesticides and are incorporated onto agricultural pesticide labels by reference. Its requirements complement the product-specific labeling restrictions and are intended to minimize occupational exposures generally.”

In 2015, EPA issued significant revisions to the 1992 WPS.  Of particular significance, 2015 revisions included a new provision requiring agricultural employers to keep workers and all other individuals out of the AEZ during outdoor pesticide applications.  The AEZ was set at 25 feet in all directions for ground pesticide applications when sprayed from a height greater than 12 inches, and 100 feet in all directions for outdoor aerial, air blast, air-propelled, fumigant, smoke, mist, and fog pesticide applications.  This provision was controversial, however, with state regulators expressing concerns with enforcing the complex AEZ requirements and farm owners expressing concerns with applying and complying with pesticide regulations.

EPA states in the final rule that it clarified and simplified the AEZ requirements based in part on input from state pesticide regulatory agencies and agricultural stakeholders after the adoption of the 2015 WPS rule.  Consistent with PRIA 4, EPA is implementing changes related only to the AEZ requirements in the WPS.  These targeted changes include:

  • Modifying the AEZ so it is applicable and enforceable only on an agricultural employer’s property, as proposed.
  • Adding clarifying language indicating that pesticide applications that have been suspended due to individuals entering an AEZ on the establishment may be resumed after those individuals have left the AEZ.
  • Excepting agricultural employers and handlers from the requirement to suspend applications owing to the presence within the AEZ of persons not employed by the establishment who are in an area subject to an easement that prevents the agricultural employer from temporarily excluding those persons from that area.
  • Allowing the owners and their immediate family (as defined in 40 C.F.R. Section 170.305) to shelter in place inside closed buildings, housing, or shelters within the AEZ, and allowing the application performed by handlers to proceed, provided that the owner has instructed the handlers that only the owner’s immediate family are inside the closed shelter and that the application should proceed despite their presence.
  • Simplifying and clarifying criteria and factors for determining AEZ distances of either 100 or 25 feet by basing the AEZ on application method.  EPA has removed the language and criteria pertaining to spray quality and droplet size, as proposed, so that all ground spray applications from a height greater than 12 inches are subject to the same 25-foot AEZ.

EPA states that many of the changes proposed in November 2019 were retained in the final rule.  Changes that were made include the following:

  • The final rule adds clarifications and revisions to the regulatory text regarding providing an immediate family exemption to the AEZ requirements.  The final rule provides that the AEZ exemption for the immediate family members applies only when the farm owner or immediately family members are inside an enclosed building within the AEZ.
  • The final rule also clarifies that owners may permit handlers to continue with applications when the owner’s family is inside an enclosed structure or home, provided that the owner has expressly instructed the handlers that only the owner’s immediate family members are inside the closed shelter and that the application should proceed despite their presence within that structure.

The final rule is available at EPA-HQ-OPP-2017-0543.  Additional information on the revisions to the AEZ requirements is available here.


 

By Susan M. Kirsch and Barbara A. Christianson

On October 24, 2019, the U.S. Environmental Protection Agency (EPA) announced that it is proposing narrow updates to the Worker Protection Standard’s (WPS) provision on the Application Exclusion Zone (AEZ) requirements.  By narrowing updates to the WPS, EPA states that it will “improve the long-term success of the agency’s Application Exclusion Zone requirements” and “would improve enforceability for state regulators and reduce regulatory burdens for farmers.”  EPA believes narrowing updates to the WPS will also continue to protect the health of farm workers and other individuals near agricultural establishments who could be exposed to agricultural pesticide applications.  The proposed updates are consistent with the 2019 Pesticide Registration Improvement Act (PRIA).

EPA Administrator Andrew Wheeler states that EPA’s proposal “would enhance the agency’s Application Exclusion Zone provisions by making them more effective and easier to implement.”  Wheeler states that “our proposal will make targeted updates, maintaining safety requirements to protect the health of those in farm country, while providing greater flexibility for farmers.”

EPA will hold a 90-day public comment period and seeks input on select updates that were publicly suggested to EPA by both state pesticide agencies responsible for enforcing the provision and agricultural stakeholders since the AEZ requirement was adopted in 2015.  The proposed updates are also consistent with the U.S. Department of Agriculture’s comments during a May 2017 meeting of EPA’s Pesticide Program Dialogue Committee.

Specifically, EPA is proposing to:

  • Modify the AEZ so it is applicable and enforceable only on a farm owner’s property, where a farm owner can lawfully exercise control over employees and bystanders who could fall within the AEZ.  As currently written, the off-farm aspect of this provision has proven very difficult for state regulators to enforce.  These proposed changes would enhance both enforcement and implementation of the AEZ for state regulators and farm owners, respectively.  Off-farm bystanders would still be protected from pesticide applications with the existing “do not contact” requirement that prohibits use in a manner that would contact unprotected individuals.
  • Exempt immediate family members of farm owners from all aspects of the AEZ requirement.  This will allow farm owners and their immediate family members to decide whether to stay in their homes or other enclosed structures on their property during certain pesticide applications, rather than compelling them to leave even when they feel safe remaining.
  • Add clarifying language that pesticide applications that are suspended due to individuals entering an AEZ may be resumed after those individuals have left the AEZ.
  • Simplify the criteria for deciding whether pesticide applications are subject to the 25- or 100-foot AEZ.

Publication of the proposed rule in the Federal Register will begin a 90-day comment period.  Comments are due on or before January 30, 2020.

When EPA included the AEZ concept in its 2015 WPS updates, of chief concern for pesticide applicators, farmers, and state departments of agriculture were the compliance and enforcement practicalities of aspects of the AEZ requirements.  For example, in scenarios where the AEZ extends to nearby roads and highways, it is difficult for pesticide applicators to be aware of every vehicle that may pass by that could enter the AEZ during applications.  It is unclear if the revised AEZ requirements adequately address these practical realities.  Agricultural stakeholders and pesticide applicators may wish to submit comments on the proposed revisions.

Additional information on the WPS is available on EPA's website.


 

By James V. Aidala, Sheryl Lindros Dolan, and Susan M. Kirsch

As reported in the trade press on February 14, 2019, following budget negotiations late on Wednesday, February 13, several legislative riders did not make it into the conference report for the final fiscal year (FY) 2019 omnibus spending package.  This purportedly includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or the long-awaited Reauthorization known as “PRIA 4.”  This may be the result of political pressure to avoid another government shutdown with a “clean bill” package capable of garnering the necessary votes.  The Senate and House are expected to vote on the omnibus package today, February 14, 2019, ahead of the expiration of the current budget resolution on February 15.  While much is still in flux, the final omnibus package, once passed, will provide a clearer picture on any PRIA implications.  At this time it appears that, contrary to past budget resolutions, PRIA 3 will not be extended.  More information on the recent PRIA extensions is available in our blog items Continuing Resolution to Re-open the Government Includes PRIA Extension and Registrants Face PRIA and Shutdown Issues.

In the event of a lapse, the “phase-down” provisions in the statute will mean that new submissions require a reduced fee schedule, but submissions will no longer have an associated PRIA deadline for a decision on the application.  The U.S. Environmental Protection Agency (EPA) will likely “clarify” in the coming days and weeks what this means for any expectation for an application submitted during this time.  During the recent shutdown, EPA stated that applications submitted during that temporary lapse only required the reduced fee.  At that time, however, since no deadline was required for such an application, EPA advised that applicants should expect guidance as to when to expect a decision (that is, in effect, do not bother to submit things during the shutdown period since PRIA actions with an associated deadline will have priority for the foreseeable future).  When the federal government reopened on January 28, however, EPA processed all applications received during the shutdown as PRIA actions submitted on January 28.

Now with PRIA likely not in effect after February 15, 2019, even with an approved EPA budget for FY2019, EPA will have to evaluate what to communicate to applicants about what to expect during the time of the PRIA 3 phase-down.  Any plans for this period may be affected by provisions in PRIA 4.  On February 13, 2019, the Senate introduced standalone PRIA 4 legislation (S. 483) with bipartisan support which could facilitate relatively quick Senate action on a PRIA 4 proposal.  The House would also need to take action to renew the program.

Because no PRIA action was taken in the budget agreement, important questions now swirl about the program, including:  

  • What happens to any new submissions?  
  • Will there be impacts on pending deadlines?  
  • What exactly will happen to any submissions made during the current “no PRIA” period?  
  • What might be the longer term impact of this (in)action on general pesticide program operations (e.g., staffing, contracts, schedules for non-PRIA actions)?

EPA will be addressing these and many other important questions over the next few days. 


 

By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan

Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.

Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown.  According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned.  Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends.  For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.

The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally.  Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR.  This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress.  Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.

This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.

Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications.  OPP states on its web site:

  • Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
  • Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
  • Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.

Registrants should monitor developments closely. 


 

By Margaret R. Graham

On September 20, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT).  The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.”

The webinar will be presented by Dr. Greg Kruger, a weed science and application technology specialist from the University of Nebraska-Lincoln and will cover different methods of ground application, best practices for reducing pesticide spray particle drift when using ground application equipment, and a discussion of the optimization of weed control.  Registration is available online.

More information on other pesticide applicator issues, including the Worker Protection Standard, is available on our blog.


 

By Heather F. Collins

On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year.  The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically.  The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration. 

This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases.  Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page.  This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported.  EPA states:  “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.”  EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.

EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.

Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions.  Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.

More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.


 

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.


 

By Sheryl Lindros Dolan

On December 16, 2014, the U.S. Environmental Protection Agency (EPA) will host a half-day workshop on the application process for the use of inert ingredients in pesticide products. The workshop will take place in Arlington, Virginia. The goal of the workshop is to clarify the necessary elements of an application for approval to use an inert ingredient in a pesticide product. Complete application packages save applicants time and money, and reduce the number of application rejections. The workshop will cover: selection of a Pesticide Registration Improvement Act (PRIA) category, elements of an application, EPA’s evaluation process, and a retrospective review of inerts under PRIA. EPA will answer stakeholder questions throughout the workshop.