EPA Representatives Discuss PRIA Process Improvements at Stakeholder Meeting

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CPDA and other members of the PRIA Industry Coalition attended the EPA PRIA Quarterly Stakeholder Meeting held at the Agency’s Office of Pesticide Programs (OPP) headquarters in Arlington, Virginia on November 13, 2019. The meeting included OPP leadership from all three registering divisions (RD, AD and BPPD). During the meeting, EPA representatives presented a detailed set of metrics on PRIA submissions received and completed during FY 2019,  the FY 2019 rate of on-time completions by product type, the percentage of completed PRIA decisions with renegotiated due dates, the Agency’s progress in reducing the backlog of non-PRIA fast track amendments and notifications, and other indicators of the Agency’s progress in implementing PRIA and improving process efficiencies.

OPP Director Rick Keigwin opened the meeting with an overview of EPA’s activities during the past year in implementing “Lean” management initiatives aimed at improving efficiencies in product review. Among these are “A3” projects which, according to Keigwin, are consistent with PRIA’s core emphasis on process improvements. The A3 approach is an established problem-solving technique that involves the identification of a problem, the desired goal or resolution of the problem, and the steps and resources necessary to achieve the intended outcome. The A3 project is presented on a single sheet of ISO A3-sized paper which serves as a problem-solving template from which the name of this approach is derived. According to Keigwin, each senior executive at EPA was asked to sponsor an A3 project of their choosing germane to a problem within their specific division that adversely impacted product review, with the goal of achieving at least a 25% improvement in performance. Keigwin told Coalition members that A3 projects will continue in FY 2020 as the Agency looks for new ways to improve process efficiencies in accordance with one of the central principles of PRIA.

In his other remarks, Keigwin indicated that EPA needs additional staff to maintain PRIA timelines. As such, the Agency expects to be in a “hiring mode” for the foreseeable future. At the present, the rate of new hires has kept pace with the rate of attrition thus leaving personnel levels unchanged. However, Keigwin noted that additional staff departures are anticipated in the near future and several OPP managers recently visited Research Triangle Park in North Carolina to recruit new employees. Keigwin pointed out that the language in PRIA 4 which removes the previous constraint limiting EPA’s ability to spend maintenance fees that had accumulated over the years as a result of appropriations falling short of PRIA baseline levels, will provide some relief as the Agency seeks to hire new staff.

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Keigwin then stated that PRIA renegotiation rates across all OPP registering divisions are high – perhaps higher than they have ever been historically. He thanked those companies that have been working with EPA in prioritizing product submissions that remain pending. Keigwin emphasized that this exercise has assisted EPA in allocating its resources to those actions deemed to be of most importance to the registrant. The Agency is hopeful that deployment of “Lean” initiatives in combination with an increase in staffing will alleviate the number of renegotiations and the backlog of product actions awaiting review.

Update on the Status of Revised PR Notice 98-10 on Notifications

In other updates, EPA representatives stated that the Agency has completed a revised draft of PR Notice 98-10 on notifications along with a response to public comment on the proposed changes. However, the revised draft must go through various management level reviews which will take some time. In addition, the President recently signed an Executive Order which sets forth certain requirements on the issuance of federal guidance documents including PR Notices. EPA is trying to determine what, if any, additional steps are necessary before the revised PR Notice is finalized and made public. As such, EPA is waiting for guidance from the Office of Management and Budget (OMB) on what must be done to comply with the new Executive Order in relation to release of the revised PR Notice 98-10. Rick Keigwin indicated that questions surrounding requirements under the new Executive Order for the issuance of guidance documents is perhaps the main reason why EPA has yet to set a firm date for release of the final revisions to PR Notice 98-10. OPP PRIA Coordinator Steve Schaible reminded meeting participants that until the revised PRN 98-10 is in place, registrants should follow the existing PR Notice 98-10 as currently written.

Results of Survey on the Use of the Pesticide Submission Portal (PSP)

The meeting with EPA included a discussion of OPP’s Pesticide Submission Portal (PSP) and an analysis of the results of an informal survey of 50 registrants, conducted by the PRIA Coalition, that sought to identify obstacles to PSP usage, areas for improvement, and potential user training topics. According to EPA, approximately 55% of those individuals who responded to the survey indicated that they use the PSP for all product submissions. Respondents who continue to make paper submissions cite missing functionality and/or submission type as the primary reason they do not use the PSP. A quarter of the survey respondents suggested that paper submission is preferable to electronic submission because:

  • It’s easier to compile documents.
  • They have limited system knowledge.
  • MRID functionality is complicated.
  • EPA sometimes processes paper faster.

According to Agency staff, about 80% of the larger submissions including more extensive studies, are submitted through the portal while smaller submissions tend to come in as paper. EPA is looking at how it can encourage greater use of the PSP by improving the system and providing training that would make it more user friendly. The Agency has established a three-phase plan that extends through March 2021 and beyond for enhancing the user experience.

Percent of Completed PRIA Decisions with Renegotiated Due Dates and On-Time Decisions

EPA next presented a slide showing a historical comparison of the percentage of completed PRIA decisions with one or more renegotiated due dates from FY 2011 through FY 2019. During FY 2019, an all-time high of 70.6% of the completed decisions for inerts had renegotiated due dates compared with 45.7% in FY 2018, 38.1% in FY 2017, 42.9% in FY 2016, 32.1% in FY 2015, 20% in FY 2014, and 14.3% in FY 2013 which was the first year the inert ingredient categories came into existence. EPA explains that the high percentage of completed decisions with renegotiated due dates across all registering divisions was largely due to the government shutdown that closed the Agency for 35 days this year during which time no PRIA work was being done.

Agency representatives also presented a slide showing the percentage of applications completed on or before the PRIA due date (including renegotiated due dates) across all registering divisions during FY 2019. For inerts, the rate of on-time completions during FY 2019 was 82.3%, down from 100% in FY 2018. The Agency’s overall on-time completion rate for all products during FY 2019 was 97.5%, slightly short of its targeted goal of 99%. EPA staff explained that following this year’s government shutdown, OPP management decided it would take more resources to reach an agreement with registrants on a revised due date through the renegotiation process than it would to simply move forward with review of the application even though the product decision would fall short of the PRIA due date (although not by much according to EPA).

Backlog of Notifications and non-PRIA Submissions

Discussion then turned to the Agency’s efforts to reduce its current backlog of notifications and non-PRIA submissions (i.e., fast track amendments) across all three registering divisions. EPA’s Registration Division sent out a letter in early October 2019 to 85 registrants with a list of pending non-PRIA items. The Agency asked registrants to confirm that the list was correct, withdraw items that were no longer needed, and use the list to indicate where opportunities exist for bundling pending actions with a single product registration. Registrants were asked to respond within two months from receiving the letter. Out of the 85 registrants that were contacted, 10% responded back to the Agency. EPA emphasized that it needs companies to help in this effort given that the Agency is dealing with attrition of staff and limited resources.

The Registration Division is engaged in other activities aimed at reducing the backlog of non-PRIA actions. Among these, managers are assigning the task of processing notifications to newer staff and using this exercise as a training tool for these employees. In addition, several branches within RD have developed ad hoc teams that work on notifications during specific times that have been carved out of the day. RD is also utilizing internal response codes that will aid in tracking trends and identifying problematic notification categories. During the discussion, one of the meeting participants raised concerns that some product managers are doing full label reviews when they process notifications and this has led to unnecessary delays in product review. She asked EPA representatives to address this issue.

Kerry Leifer (CITAB) Discusses Product Chemistry Review Initiatives

Kerry Leifer, Chief of EPA’s Chemistry, Inerts and Toxicology Assessment Branch (CITAB), discussed some of the process improvements and challenges in the area of product chemistry review for conventional products. He stated that the high rate of renegotiations in the Registration Division is due in no small part to some of the delays in the completion of product chemistry review. Leifer reported that CITAB has begun to hire more employees and is utilizing more contract resources for product chemistry review to supplement the work that is being done internally by Agency staff. He noted that an ongoing issue has been the quality of product chemistry submissions and that improvement in this area would allow EPA to be more efficient in conducting product chemistry reviews. The Agency is developing improved product chemistry templates that will be used by contractor staff as well as internal staff in the hopes this will facilitate a more efficient review process.

In his other comments, Leifer reported that CITAB is working extensively with product management teams throughout RD in seeking to reduce the number of multiple renegotiations that occur. Another area on which the Agency is focused is the expansion of self-certification of Group A product chemistry data. He stated that the Agency is hoping to soon release for the PRIA Coalition’s review a generic template that could be used as part of a pilot for the self-certification of Group A data. Leifer added that CITAB has developed a checklist of the more common problem areas EPA has observed in the area of product chemistry and that the Agency has asked the PRIA Coalition to provide its feedback on the checklist. EPA hopes that the checklist will help companies improve submissions and lead to a reduction in the number of product application rejections and resubmissions seen by the Agency.

Leifer also noted that CITAB is trying to be more strategic in its product chemistry review by bundling reviews for similar actions and maximizing its use of contractor resources.

EPA’s Lean Management Systems (ELMS) Initiatives

The discussion then turned to an overview of EPA’s implementation of Lean Management Systems (ELMS) initiatives aimed at promoting continuous and sustained improvement of internal processes. Implementation of ELMS activities within OPP began September 30, 2019 and focused on:

  1. Reducing the amount of time it takes for a product manager to receive an incoming submission (including the time it takes to receive and triage a submission, categorize the application with the proper PRIA code, and perform the 21-day completeness screen);
  2. Developing a visual system within RD using huddle boards for tracking the major milestone markers in the progress of a new active ingredient application from the time it is submitted to the Agency until the time the label is stamped, including the identification of problem areas along the way that could impede its progress (RD Director Mike Goodis noted that deficient data was a significant problem area detected by the Agency as a cause of delays in review time); and,
  3. Establishing consistency in the 90-day technical screen process used by BPPD through the use of checklists for study guidelines, instructions for reviewers, and templates for screening.

ELMS activities within OPP will be ongoing and additional initiatives will be launched during FY 2020 focusing on the improvement of efficiencies within specific OPP divisions for conducting active ingredient risk assessments and registration review.

Discussion of PRIA Related A3 Projects

During the meeting, OPP registering division managers gave presentations on PRIA related A3 projects that focused on a specific problem areas they wanted to address. The A3 project selected by EPA’s Antimicrobials Division (AD) sought to reduce the backlog of notifications by 25%. AD far surpassed its goal and achieved a 62% reduction in the backlog by: 1) expanding notification sign-off authority to product reviewers (previously sign-off authority was limited to the four product manager team leaders in AD); 2) limiting the review of notifications to the specific change sought by the registrant in the submission (some product managers have been reviewing the entire label instead of just the change addressed by the notification which sometimes led to misclassifying the submission as a more complex amendment and resulted in a lot of ‘back and forth’ between EPA and the registrant); 3) correcting erroneous codes in OPPIN (AD found that a large number of notifications had been closed out but were still shown as pending because they were never coded properly); and, 4) working with registrants to consolidate actions and encouraging them to make better submissions.

Kerry Leifer stated that the A3 project for the Registration Division involved the use of Lean tools to identify inefficiencies in the inert ingredient review process with the goal of reducing the backlog of pending new inert ingredient submissions by 25%. RD completed the project successfully and achieved a 31% reduction in the backlog. He noted that not only did EPA address the backlog of actions that were pending during FY 2019, but the Agency had to deal with new submissions coming in which could have added to the backlog. The RD A3 project utilized Lean tools such as value stream mapping that helped the Agency identify three significant sources of waste in the review process as follows: 1) wait times during which the review of inert ingredient submissions was not being conducted; 2) conveyance or how EPA goes through the discrete steps of the review process; and, 3) processing (both in-processing of submissions and the final steps of the review). Leifer stated that the Agency will build upon what it learned in this A3 project as it continues to improve the inert ingredient review process. Steve Schaible added that the inert ingredient submission categories in PRIA 4 were adjusted to better align review times and resources with the amount of work associated with each inert ingredient category.

The A3 project selected by BPPD focused on reducing the backlog of a subset of non-PRIA actions that necessitated a science review and raised some storage stability issues. The BPPD A3 project began in February 2019 with a backlog of 38 actions which has now been reduced to 13 pending actions, thus representing a 58% reduction far exceeding BPPD’s goal of a 50% decrease. In working to meet its A3 goal, BPPD developed a more streamlined review process and got “creative” in the staffing dedicated to this initiative. BPPD management invited input from the registrant community regarding other potential A3 projects to take on during FY 2020 but emphasized that its primary focus will be the continuation of ELMS activities seeking to improve and bring consistency to the 90-day preliminary technical screen where problems with a submission can be caught and resolved early on.

OPP Prepares for Move of Headquarters Office from Arlington, VA to Washington, D.C.

The meeting concluded with an update on the Agency’s plans to move OPP headquarters from Arlington, Virginia to Washington, D.C. sometime next year. The Agency is taking steps to minimize any disruption of PRIA activities and product review that may occur during the move. Among these, OPP is digitizing documents so there will be less paper to move. In addition, staff are being trained on how best to respond in the event of a worst-case scenario unfolding during the move (such as the loss or destruction of key documents). In response to a question on the Agency’s preparations in the event of another government shutdown – specifically whether those components of OPP activities that are supported by PRIA fees will continue – EPA representatives stated that historically most Agency activities shut down during government closures and that only those employees who are deemed essential are allowed to report to work. They added, however, that while this has been historical precedent, this scenario may or may not apply to possible government shutdowns that take place in the future. The EPA slides presented at the stakeholder meeting may be accessed by clicking here.

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Diane Schute

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