News

EPA Representatives Discuss PRIA Process Improvements at Stakeholder Meeting

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.

CPDA Holds its Very Successful 2019 Summer Conference & Annual Meeting in Park City!

CPDA wrapped up its very successful 2019 Summer Conference & Annual Meeting, held August 19-21 at the Hyatt Centric Park City in Park City, Utah – a beautiful resort town nestled in the scenic Wasatch Mountains. The conference featured a comprehensive speakers program focusing on issues crucial to the business operations of companies in the agrotechnology industry. The meeting also provided opportunities for networking during which attendees had the chance to reconnect with long-known industry colleagues and to make new business contacts within a congenial, social setting.

This year’s keynote address was given by Dr. Nathan Kauffman, Vice President and Omaha Branch Executive with the Federal Reserve Bank of Kansas City who provided his perspective on how economic, trade, and other factors are affecting the farm economy.

The Summer Conference & Annual Meeting covered many other important topics including the very good working relationship that CPDA has established with both the states of California and Washington, providing information and comments on proposed regulatory actions that could affect the registration of adjuvants. Other discussion focused on the challenges facing the ag retail-distribution industry, regulatory initiatives from EPA and other federal agencies impacting the agrotechnology industry, opportunities in the biostimulants market, and newly adopted changes to the Canadian data compensation process for pest control products – just to name a few.

We were also pleased to feature on our program representatives from two of our allied trade association partners that we work closely with – CropLife America (CLA) and the Agricultural Retailers Association (ARA). We extend our thanks to Chris Novak, Beau Greenwood and Dr. Ray McAllister from CLA and to Richard Gupton from ARA for providing the audience an overview of the initiatives on which we have collaborated jointly in crafting solutions to challenges common to our respective memberships.

CPDA President Gary Halvorson Welcomes New and Returning Members to CPDA

In delivering his opening remarks at the Summer Conference & Annual Meeting, CPDA President Gary Halvorson offered a warm welcome to the following companies that have either joined CPDA for the first time or rejoined as a returning member since January of this year:   Brandt Consolidated, Inc.; Earth Science Laboratories; EGE Products; Ethox Chemicals, LLC; R3 Ag Consulting, LLC; Wilbur-Ellis Company; and Winfield United. Please join us in welcoming these companies to the CPDA membership.

 The 2019-2020 Roster of the CPDA Board of Directors is Announced

The next order of business at the Summer Conference & Annual Meeting was the adoption of the new roster of members of the CPDA Board of Directors for 2019-2020. We are happy to announce an expansion of the Board of Directors from 11 seats to its current roster of 16 seats. The expansion of the Board will enhance our ability to represent all segments of the CPDA membership and to develop Council positions and strategies that are reflective of the diverse makeup of our members. Please join us in thanking what is a very active and engaged group of individuals for their willingness as members of the Board to dedicate their time, talent, energy, and expertise in ensuring the continued growth and success of CPDA.

CPDA Honors Individuals at its Annual Awards Banquet

Every year at the Summer Conference & Annual Meeting, CPDA recognizes selected individuals for an achievement, contribution, or service provided to the Council. This year, meeting attendees gathered on the night of Tuesday, August 20th at the Hyatt Centric Park City for the annual CPDA Awards Banquet to recognize and celebrate four individuals whose many accomplishments have benefited members of CPDA and the agrotechnology industry. Master of Ceremonies at this year’s event was Gary Groves (Solvay).

Among this year’s award recipients was Robert Ehn, R3 Ag Consulting, LLC, who was given the CPDA “Service to the Industry Award” in recognition of his work with the California Department of Pesticide Regulation in helping to shape policy and support industry registration submissions for adjuvants and other agrotechnology products. Presenting the award was CPDA President Gary Halvorson who expressed his deep appreciation for the strong relationship the two of them have enjoyed going back to when they worked together during the early days of their careers.

From left to right are Robert Ehn, CPDA President Gary Halvorson, Dr. Kevin Crosby, and Dr. Ray McAllister.

The CPDA “Service to the Industry Award” was also bestowed upon Dr. Ray McAllister, CropLife America, in honor and recognition of a career spanning three decades devoted to advocating for science-based regulation of crop production products and technologies. In presenting the award, CPDA President Gary Halvorson highlighted Dr. McAllister’s collaboration in working closely with the Council membership to achieve successful outcomes on several regulatory initiatives of crucial importance to both associations.

Carmine Sesa (left) presents Dr. Kevin Crosby with the CPDA “Service to the Council Award.”

Dr. Kevin Crosby, Adjuvants Unlimited, LLC, received the CPDA “Service to the Council Award” in honor of his dedication and leadership working with the state of Washington in developing appropriate naming for the principle functioning agents used in adjuvants. Presenting the award was Carmine Sesa, AgMarket Results, who thanked Kevin for serving with him as co-chair of the CPDA Inerts Working Group and for his many efforts that led to CPDA’s re-engagement as a principle member of the CPDA/CLA Joint Inerts Steering Committee on which Kevin also serves as co-chair.

Carmine Sesa (left) and Gary Groves enjoy a lighter moment at the CPDA Awards Banquet.

Carmine Sesa not only presented an award, but he was also the recipient of the CPDA “Service to the Council Award” given to him in honor of his long-time leadership on inert ingredient issues that helped the association move forward with its current mission dedicated to promoting the importance of these products in agricultural production. Presenting the award was Master of Ceremonies Gary Groves (Solvay) who recounted fond memories of the time he and Carmine worked together and who expressed his deep admiration and respect for Carmine emanating from a long-standing professional relationship and friendship that continues to grow today.

 

CPDA Thanks the Sponsors of the 2019 Summer Conference & Annual Meeting!

CPDA would like to extend its sincere thanks to the sponsors of the 2019 Summer Conference & Annual Meeting. Sponsorship plays a crucial role in enhancing the quality and value of CPDA meetings. Please join us in recognizing the following companies for their generosity in sponsoring this year’s summer meeting:

Diamond Level:  Chemorse

Platinum Level:  Precision Laboratories, LLC

Gold Level:  Adjuvants Unlimited, LLC; Helena Agri-Enterprises; KALO, Inc.; and Rosen’s, Inc.

Silver Level:  Clariant Corporation, Ethox Chemicals, Exacto, Inc.; Stepan Company; and Stillmeadow, Inc.

Speaker Presentations

The speaker presentations from the 2019 CPDA Summer Conference & Annual Meeting may be accessed by clicking the links below.

“The Outlook for the Agricultural Economy,” Dr. Nathan Kauffman, Federal Reserve Bank of Kansas City, Omaha Branch

“The Growing Benefits of CPDA Membership,” Arthur Bass, Chair of the CPDA Membership Committee, Chemorse

“Socializing Application Enhancement Certification,” James Reiss, Chair of the CPDA Board of Directors, Precision Laboratories, LLC

“Adjuvant Registration in the State of Washington,” Dr. Kevin Crosby, Adjuvants Unlimited, LLC

“Efficacy Data for Adjuvants and California Registration Requirements,” Robert Ehn, R3 Ag Consulting, LLC

“Better. Together.,” Chris Novak, President & CEO, CropLife America

“CropLife America’s Regulatory Initiatives, Large and Small,” Dr. Ray McAllister, CropLife America

“An Overview of the CPDA/CLA Joint Inerts Steering Committee (JISC),” Dr. Kevin Crosby, Co-Chair of the JISC, Adjuvants Unlimited, LLC

“Plant Biostimulants:  Current State and Future Directions,” Dave Lanciault, Agricen

“Biostimulants:  An Evolving Regulatory Arena,” Shannon Bryant-Spas, TSG Consulting

“Policy Challenges Facing Ag Retail-Distribution Industry,” Richard Gupton, Agricultural Retailers Association

The 2019 CPDA Summer Conference & Annual Meeting Offered Opportunities to Network with Familiar Faces and to Make New Contacts!

Thank you for attending!

CPDA Urges USDA to Extend Final Planting Date Deadlines

CPDA has written to USDA Secretary Sonny Perdue requesting that the Department consider an extension of the final planting dates for insured crops in those states where farmers have experienced the devastating impacts of the natural disasters that have severely disrupted the 2019 growing season. In its June 7, 2019 letter sent to the Secretary, CPDA pointed out that if USDA moves forward at this time with making prevented planting payments to those farmers, acreage that could otherwise be planted will instead remain idle for the remainder of this year’s growing season. “This will negatively impact all parts of the agricultural supply chain including companies that manufacture, formulate and distribute products that farmers rely on for crop production and pest control,” CPDA stated. Rather than abandoning this year’s planting season as a total loss, CPDA urged USDA to consider a possible interim remedy in the form of an extension of the final planting deadline dates as recommended by the Agricultural Retailers Association (ARA) in a June 4, 2019 letter to Secretary Perdue. The ARA letter addressed USDA’s implementation of the Additional Supplemental Appropriations for Disaster Relief Act of 2019, signed into law by President Trump on June 6, to provide $4.6 billion to USDA for agricultural-related losses, emergency timber restoration, farmland repair, and watershed recovery work.

ARA explained that should farmers choose not to plant in 2019 and instead take prevented planting compensation, retailers who provide seed, seed treatment, fertilizer and other inputs for that crop will suffer the negative consequences that come from holding unsold product. CPDA emphasized that similarly, many companies which manufacture or supply tank-mix spray adjuvants and pesticides sold by retailers will be adversely affected as demand for their product falls due to reduced acreage being planted. 

“The time-sensitive nature of the growing season and the logistics involved in transporting product requires that companies develop their manufacturing plans well in advance of the beginning of the planting season,” CPDA stated. “Product must be readily available to meet the needs of the farmer within a very narrow window as the growing season progresses. A change in planting intentions from what was originally expected will have serious implications for companies that are left with excess product inventory that cannot be moved should there be a significant reduction in planted acreage resulting in lower demand.”

CPDA concluded its letter by reiterating its support of the recommendation made by ARA calling for an extension of the final planting date deadlines. CPDA joined with ARA in emphasizing that this is a remedy that would meet the needs of growers who want to farm their land as well as those who serve the growers. To learn more please read the letters from CPDA and ARA.

Presentations from CPDA’s 2019 Adjuvants & Inerts Conference Now Available!

CPDA’s 2019 Adjuvants & Inerts Conference, “Developing Trends and Emerging Needs of the Agrotechnology Industry,” held April 29-May 1 at the Grand Hyatt Denver in Denver, Colorado, featured a comprehensive and informative speakers program that covered a wide variety of topics of key importance to the agrotechnology industry. This year’s conference drew an audience of nearly 160 attendees representing all segments of the agrotechnology industry and addressed the latest innovations, research and trends in application technologies and other areas of crop protection and production. The presentations at this year’s conference equipped attendees with a better understanding of the many complexities shaping today’s agricultural economy and farm markets.

Thank You to this Year’s Sponsors!

Our sincere thanks and gratitude is extended to the sponsors of the 2019 Adjuvants & Inerts Conference. The generosity and support of these companies play a key role in CPDA’s ability to enhance the value to be derived from attending our conferences. Moreover, sponsorship is an excellent way to raise the visibility of your company. Please join us in recognizing the CPDA 2019 Annual Adjuvants & Inerts Conference sponsors:

Diamond Level:  Chemorse; Helena Agri-Enterprises; Huntsman Performance Products; Oxiteno; and Stepan Company

Platinum Level:  Adjuvants Unlimited, LLC; Nouryon; and Precision Laboratories, LLC

Gold Level:  Croda; Evonik Corporation; and TSG Consulting

Silver Level:  Brandt; Clariant Corporation; Ethox Chemicals; KALO; Oleon; and Stillmeadow, Inc.

Speaker Presentations

The speaker presentations from the CPDA 2019 Annual Adjuvants & Inerts Conference may be accessed by clicking the links below.

April 30, 2019

“Welcome to CPDA’s Adjuvants & Inerts Conference,” Gary Halvorson, CPDA President; and Dave Ferguson, Agrotechnology Committee Co-Chair, Huntsman Performance Products

“The State of the Farm Economy,” Dr. Terry Barr, CoBank

“CPDA and CLA Collaboration,” Gary Halvorson, CPDA President

“CPDA Priorities and Value of Membership,” James Reiss, Chair, CPDA Board of Directors, Precision Laboratories, LLC

“CPDA Adjuvant Certification Program,” Greg Grant, Croda

“Inerts Working Group Update,” Carmine Sesa, CPDA Inerts Working Group Chair, AgMarket Results, LLC

“The BIT Experience and Update,” Dr. Kevin Crosby, Adjuvants Unlimited, LLC

“The Impact of NGO’s (Non-Government Organizations) on Regulations Affecting Registration of Pesticides and Adjuvants in California,” Robert Ehn, R3 Ag Consulting, LLC

“Adjuvant Technology Trends in Patents:  2016-2019,” R. Scott Tann, pHocas LLC

“Post Patent Agrochemical Formulation Overview and Trends,” John M. Moyer, Ethox Chemicals

“The Benefits of Adjuvants when Herbicide Efficacy is Challenged,” Dr. Ryan Edwards, Winfield United

“Research and New Developments in Adjuvants – A University Perspective,” Dr. Bryan Young, Purdue University

“Facing the Glyphosate Resistance Issues Scenario – Impacts on Agrochemicals and Application Technologies,” Dr. Ulisses R. Antuniassi, São Paulo State University (UNESP) – Botucatu/SP – Brazil

May 1, 2019 – Session A: “Overall Improvement of Spray Quality and New Spray Technologies”

“Spray Quality: Where Does Biology Trump Physics?”, Dr. Bryan Young, Purdue University

“Advancements in Nozzle Technology,” Nick Fleitz, Pentair Hypro

“A Comparison of Agricultural Spray Measurement Techniques,” Dr. Steven A. Fredericks, Winfield United

“Effective Application Technology Management for Maximum Deposition and Coverage,” Drs. Greg R. Kruger and Bradley K. Fritz

“Encouraging the Adoption of Application Enhancement Technologies,” Drs. Bradley K. Fritz and Greg. R. Kruger

May 1, 2019 – Session B: “Biologicals – Current and Future Trends and Challenges”

“Biostimulants – Opportunities and Registration Challenges,” John L. Peterson, Consulting Chemist

“Biopesticides for Crop Protection:  A Revolution or an Evolution,” Dr. Natarajan “Bala” Balachander, AgBiome

“Plant Growth Regulators and Biostimulants:  Challenges and Opportunities,” Jim Scruggs, Fine Americas

Scenes from the 2019 CPDA Adjuvants & Inerts Conference

Thank you for attending!

CPDA Participates in EPA Quarterly PRIA Stakeholder Meeting

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 headquarters in Arlington, Virginia on March 13, 2019. The meeting included OPP leadership from all three registering divisions (RD, AD and BPPD). EPA personnel gave a brief summary of the events leading up to the March 8, 2019 enactment of PRIA 4, highlighted some of the new provisions in the reauthorized statute, and discussed the Agency’s plans to implement PRIA 4 and eliminate the backlog of actions awaiting review that was created by the federal government shutdown earlier this year.

In an effort to reduce the backlog of submissions mentioned above, EPA has been reaching out to companies that had multiple actions in the queue and is asking those companies to identify which of those registration actions that remain pending are deemed priority actions. EPA is also requesting that companies agree to a 90-day extension for the review of their product applications. EPA staff signaled they will likely continue to seek additional extensions moving forward but that the additional time sought will be 60 rather than 90 days.

EPA personnel also addressed product applications that were received from February 15, 2019 through March 7, 2019, the period during which PRIA 3 had lapsed and fees were reduced by 70% and the statutory timelines were no longer in effect. Those applications may be withdrawn and then resubmitted with the new PRIA 4 fee. The application packages will receive a PRIA 4 timeline for review as established under the current law. EPA, however, will keep 25% of the fee that was submitted with the original product application during the time period in which PRIA had lapsed.

OPP staff also discussed efforts to reduce the backlog of non-PRIA fast track amendments and notifications and indicated that non-PRIA actions could be bundled together as one submission rather than being submitted as separate label amendments. In addition, OPP representatives suggested that companies could include a PRIA label and a non-PRIA notification in one submission. EPA is considering possible ways to do a quicker review of notifications that might include providing product managers increased authority to sign off on these actions. OPP representatives signaled that they are preparing an update on PR Notice 98-10 on Notifications, Non-notifications, and Minor Formulation Amendments that will address the comments received by the Agency in response to changes proposed previously. In related developments, on April 2, 2019 CPDA and its allied industry partners will be meeting with management from OPP registering divisions to discuss the issue regarding the current backlog of notifications awaiting action.

In other discussion, EPA staff reported that the Agency is considering how best to use the maintenance fees that have accumulated over the years as a result of the previous appropriations constraint that limited the Agency’s ability to spend those funds. Staff noted that the Agency’s Office of Inspector General has recommended the development of a spending plan for maintenance fees under which no more than four months of maintenance fees could be carried over from year to year.

EPA has updated its web site to include PRIA 4 fee tables, revised decision trees, and the interpretations associated with each PRIA 4 fee category. Agency staff are also developing a table that will compare PRIA 4 to PRIA 3 and will make that available on the Agency’s web site very shortly. A summary of the March 13th stakeholder meeting developed by DC Legislative & Regulatory Services on behalf of the PRIA Industry Coalition of which CPDA is a member is available by clicking here. In addition, a presentation made by EPA on what’s new in PRIA 4 may be accessed by clicking here and an overview of the Agency’s PRIA implementation activities including a compilation of product actions completed to date is available here.

CPDA Urges EPA to Deny Petition Seeking Testing of Every End-Use Formulation and Tank Mixture

CPDA has collaborated with CLA, RISE and the Biological Products Industry Association (BPIA) in submitting joint industry comments to EPA on March 21, 2019 in response to a petition filed by the Center for Food Safety (CFS). The CFS petition requests that the Agency revise its testing requirements for pesticides prior to registration. Specifically, CFS is askiTng that the Agency expand its testing requirements to include whole pesticide formulations so as to account for the toxicological effects of inert and adjuvant ingredients and the testing of tank mixes to assess the interaction between pesticide ingredients. CFS maintains that inert ingredients may interact synergistically with active ingredients in ways that EPA cannot predict and that additive effects are not accounted for in pesticide risk assessments. As such, CFS argues that essentially all testing called for under CFR Part 158 as a requirement for registration must be conducted on every end-use product formulation and tank mixture. CFS believes this change is needed to meet the applicable safety standards of FIFRA.

In the joint comments, the industry group urged the Agency to deny the CFS petition emphasizing that EPA requires significant amounts of data on inert ingredients to support tolerance exemptions and the maximum allowable percent of the component in a formulation. The group pointed out that EPA can request additional information on a case-by-case basis for inert ingredients, formulations, and tank mixtures to support safety assessments. The group also argued that the expanded testing requested by CFS would be contrary to the approach previously adopted by Congress in amending FIFRA that was predicated on avoiding the duplication of data and reducing the burden placed on companies generating the data. The industry group explained that Congress’s goal in amending FIFRA in 1978 was to enable EPA to use a generic approach to pesticide registrations under which the Agency would devote more attention to basic or technical materials. “Not only is EPA permitted to base its decisions about formulated products on data generated on the ‘basic ingredients,’ Congress specifically intended that EPA focus on those ‘basic ingredients’ and apply the Agency’s findings to its evaluation of end-use product formulations,” the group stated. CPDA and the others further noted that EPA requires approximately 100 studies for the typical agricultural pesticide, and the average cost of these studies is approximately $150 million. “To conduct virtually all such tests on every end-use pesticide would be economically prohibitive, and there is scant evidence that it would better inform EPA of a pesticide’s risks,” the group cautioned. 

Click here to access a copy of the comments submitted by CPDA, CLA, RISE and BPIA in response to the CFS petition. The petition, supporting materials, and comments may be accessed online at www.regulations.gov (Docket ID number EPA-HQ-OPP-2018-0262).

PRIA 4 Enacted Into Law

On March 8, 2019, President Trump signed into law S. 483, the “Pesticide Registration Improvement Extension Act of 2018” (PRIA 4). The measure, which provides a long-term reauthorization of PRIA, was introduced in the Senate on February 13, 2019 as a stand-alone bill and was adopted in that chamber by voice vote on February 14th. As introduced, S. 483 referenced H.R. 1029, the Pesticide Registration Enhancement Act, as amended by the Senate on June 28, 2018 during the last Congress. On February 25, 2019, under unanimous consent, the House approved the “long form” of the measure containing the full text rather than just a reference to the June 2018 Senate passed bill. In a parliamentary procedure that did not affect the substance or intent of the legislation, the Senate subsequently took up the House passed measure and approved it by voice vote on February 28th. S. 483 was then sent to the White House for the President’s signature.

PRIA 4 authorizes EPA to collect registration service and maintenance fees through 2023, establishes firm timelines for the review of pesticide and inert ingredient submissions, and makes several technical changes to PRIA 3. CPDA has long been a proponent of PRIA and is pleased that legislation providing for a long-term reauthorization of the statute has now been enacted into law.

A summary of the key provisions contained in PRIA 4 and a comparison with previous versions of the statute was prepared by DC Legislative & Regulatory Services on behalf of the PRIA Industry Coalition of which CPDA is a member. This document may be accessed by clicking here.

CPDA continues to work as a member of the PRIA Industry Coalition in providing input to EPA as the Agency proceeds with its plans to implement the newly enacted PRIA 4.

WSDA Addresses CPDA Concerns Over CBI Relating to Proposal for Principal Functioning Agents in Adjuvant Formulations

In a significant win for CPDA, the Washington State Department of Agriculture (WSDA) has issued a memorandum, dated December 11, 2018, in which the Department addresses the concerns of the Council regarding WSDA’s proposed plan requiring spray adjuvant registrants to use a more specific chemical name in the Principal Functioning Agents (PFA) section of their product label. The proposal, part of the WSDA Spray Adjuvant Labeling Consistency, Clarity and Compliance guidance issued in March 2017, mandated that the names of the three principal functioning agents on the label and the CSF must be associated with the specific Chemical Abstracts Service (CAS) number for the ingredient. 

In response to concerns voiced by CPDA and work group members that the proposed synonym names as well as the resulting label requirements would result in the disclosure of confidential business information (CBI) for products registered by WSDA, the Department has agreed to delay the implementation of the “specific chemical name” portion of the March 2017 guidance until family/group chemical names for PFA’s can be evaluated and added to the list of synonyms.  As such, spray adjuvant registrants will be allowed to continue to use the chemical class descriptor in the ingredient statement appearing on the label instead of the chemical name.

The memorandum, authored by Kelle Davis, WSDA Program Manager for Registration and Licensing Services, states that registrants who were directed prior to December 11, 2018 to make label revisions to amend their PFA statement in response to the March 2017 guidance on Spray Adjuvant Ingredient Statements, may either delay the revision until further notice or submit their updated label if they choose to do so. Label revisions requested by WSDA for any other reason still need to be completed. The memo sets forth revised criteria for listing principal functioning agents on spray adjuvant labels.

The WSDA memo represents the culmination of a series of meetings CPDA has conducted with Department staff since the summer of 2018.  CPDA and work group representatives objected that the WSDA naming proposal for principal functioning agents would force the disclosure of CBI for products registered by the Department and could result in some companies choosing to drop their product registrations. In its engagement with WSDA, CPDA collaborated with its allied industry partners, including Heather Hansen, Executive Director, Friends of the Fields and Forest and Far West Agribusiness Association, in persuading the Department to delay implementation of the naming proposal.

CPDA appreciates the willingness of WSDA staff to consider the concerns of spray adjuvant registrants relating to how the proposal could force the disclosure of CBI. CPDA and registrant stakeholders will be working with WSDA to evaluate the family/group names to make sure they meet WSDA’s requirements while allowing registrants more flexibility in their PFA chemical names. A copy of the WSDA memo may be accessed by clicking here. For more information, please contact CPDA Interim President Gary Halvorson at ghalvorson@cpda.com.

For additional background on this issue, read more here.

CPDA-Canada Submits Comments to PMRA on Revised Consultation that Sets Forth Additional Changes to the Ministerial Agreement for Data Protection

On December 17, 2018 CPDA-Canada submitted comments in response to the Pest Management Regulatory Agency (PMRA) updated consultation that proposes additional changes to the Agreement for Data Protection under Section 66 of the Pest Control Products Act (PCPA), commonly referred to as the Ministerial Agreement for Data Protection. The Ministerial Agreement sets forth the procedures and requirements that must be followed when a generic pesticide registration applicant wishes to rely on a registrant’s compensable data to register a generic pesticide. The updated PMRA consultation document contains draft changes to the Ministerial Agreement for Data Protection based on the public comment the Agency received in response to its original consultation published on December 30, 2016. As reported previously, on February 24, 2017, CPDA-Canada submitted comments to PMRA on its prior consultation expressing disappointment that the Agency’s proposed mechanism failed to equitably balance the interests of companies that develop new pesticides (‘innovator’ companies) with the interests of companies that produce generic pesticides (‘generic’ companies).

In its latest submission to PMRA, CPDA-Canada reiterated its concerns set forth in its previous comments but also acknowledged and commended the Agency for several small improvements contained in the revised consultation. Among these, CPDA-Canada thanked PMRA for the addition of language aimed at deterring poor conduct in negotiations over data compensation through the proposed imposition of consequences that could be placed on parties acting in bad faith. CPDA-Canada also expressed its support for provisions that would establish a definitive timeframe by which an applicant would be required to provide all parties with notice of intent to initiate arbitration once negotiations fail. In addition, CPDA-Canada cited new provisions that would allow an applicant to opt out of arbitration proceedings at any time. Previously, if an applicant was uncomfortable with the final offer made by the registrant, they would not pursue arbitration because there was no opt-out mechanism and the arbitration tribunal’s award decision would be binding.

Despite these improvements, CPDA-Canada pointed out that deficiencies in the data compensation negotiation and arbitration scheme, as set forth in the updated consultation document, have not been satisfactorily addressed by PMRA. For example, the proposed revisions would give the Arbitral Tribunal the power to assign fees, such as legal fees, incurred by one party during arbitration to the other party. CPDA-Canada explained that parties to an arbitration typically agree that company specific costs are the responsibility of that company and not the other company.

CPDA-Canada also objected to a provision in the revised consultation that would give the Arbitral Tribunal the unilateral ability to extend the arbitration process which would add more time and expense to the proceedings. CPDA-Canada maintained that any extension should be agreed to in writing by both parties to the arbitration and should be limited to no more than 30 days.

In its other comments, CPDA-Canada called upon PMRA to retain the “cost sharing” provisions that appeared in its original consultation document. That language specified that compensation should be based on the equitable sharing of costs between a data owner and follow-on applicant. Where data compensation for the same data has already been paid by another generic previously, an award in a subsequent process could be based on the determined cost of data divided by the number of applicable parties (i.e., the data owner, the generic company that paid compensation in the first process, and the applicant in the subsequent process).

CPDA-Canada will continue to engage with PMRA on the inequities in the current Canadian data compensation mechanism, the process for the registration of tank-mix adjuvants, and the barriers to entrance of member company products into the Canadian market. To access a full copy of the recent comments submitted by CPDA-Canada to PMRA, please click here. 

The Value of CPDA Membership

CPDA is the preeminent U.S.-based industry trade association supporting the interests of the agricultural adjuvants and inert ingredients industry, and manufacturers, formulators and distributors of post patent pesticides and other agrotechnology products through its robust legislative and regulatory affairs programs.  The core of CPDA’s mission is built on the realization that issue priorities can differ significantly depending on whether your company is a producer, formulator/distributor, or an adjuvant/inert ingredient supplier.  Each of these segments within the agrotechnology industry faces a unique set of challenges in retaining a competitive edge in the marketplace.

To better position ourselves for the future, CPDA has charted a new strategic path with the goal of ensuring that the legislative and regulatory issues faced by each of these industry segments – producers, formulators/distributors, and adjuvant/inert ingredient suppliers – continue to be made a priority and receive the attention necessary for these companies to thrive in an ever-changing and competitive market. As a member of CPDA, companies have the opportunity to participate on one or more of three groups being established that will focus on the legislative and regulatory issues and needs germane to each of these individual market segments. This approach will empower member companies by giving them ownership over the issues applicable to the industry segment in which they do business and provide them the means to become “part of the solution.”

This new structure will assist CPDA in more effectively serving as the industry voice and advocate for uniquely challenging issues specific to the agrotechnology industry – issues that other agricultural chemical trade associations simply do not address. Membership in the Council provides companies a “seat at the table” in advocating for policy changes that impact their operations and protect their interests.  When an issue suddenly arises that affects a segment of our membership, CPDA responds by directing staff and member expertise to resolve the problem.  For an individual company to attempt problem resolution, the costs could be prohibitive and the effort ultimately unsuccessful.  As a trade organization, CPDA is well positioned to represent a large group of impacted companies and to speak as one voice for the agrotechnology industry on critical policy matters.  Past experience has proven that the voice of the association has been heard and addressed by the EPA, OSHA and state agencies.

CPDA’s activities in defending the interests of its members focuses on engaging state and federal legislators to shape new or existing legislation to the desired outcome; collaborating with agency personnel to inform the regulatory decision-making process; drafting and submitting comments on proposed rules and legislation; and advocating for favorable public policy. The following are just a few examples of the issue priorities that CPDA has devoted its time and resources to in representing the interests of its members in the federal and state policy arenas:

  • CPDA has engaged extensively with OSHA on advocating for changes to the Hazard Communication Standard (HCS 2012) that would stipulate that sealed containers in warehouses would not have to be relabeled based on new hazard information if an updated label is transmitted electronically to downstream entities as is allowed for updated safety data sheets.  CPDA has voiced its concerns to OSHA that distributor warehouses are not equipped to safely relabel sealed product containers and that this requirement would subject warehouse workers to unnecessary health and safety risks.

 

  • CPDA continues to work in strong support of enactment of legislation that would provide a long-term reauthorization of PRIA. The PRIA category fees and review timelines important to our member are established under PRIA ensure that decisions on pesticide product and inert ingredient submissions are made by EPA on a timely basis.  This provides companies the certainty they need in planning for the demands of the growing season. CPDA’s efforts played an important role in the inclusion of PRIA as part of the House and Senate Farm Bills. With current Farm Bill programs set to expire on September 30, 2018, the House and Senate majority leadership are hoping to complete work on a conferenced bill very shortly. CPDA is collaborating with its allied trade association partners on the PRIA Coalition to ensure the PRIA language remains in the final Farm Bill.

 

  • CPDA has devoted considerable resources in seeking the elimination of the duplicative Clean Water Act permitting requirement for FIFRA registered pesticides applied in, over or near waters of the United States. The Council was successful in securing the inclusion of language, known as the National Pollutant Discharge Elimination System (NPDES) provision, in both the current versions of the House and Senate passed Farm Bills that would obviate the need for this redundant permit for the lawful application of pesticides.

 

  • CPDA continues to meet with EPA staff on a variety of pesticide drift issues, and recently developed a set of recommendations on possible changes to the Agency’s Drift Reduction Technology (DRT) verification test protocol, a key component of the star rating aspect of the DRT Program. CPDA remains committed to working with EPA on pesticide drift and educating Agency staff on tank-mix adjuvants and the nature of pesticide formulations.

 

  • CPDA is actively engaged on key state issues including the pending changes to product label warning requirements slated to go into effect at the end of August 2018 under California Proposition 65. CPDA recently joined with several other industry trade associations in submitting comments to California’s Office of Environmental Health Hazard Assessment (OEHHA) voicing concerns that the proposed Proposition 65 safe harbor warning requirements conflict with EPA requirements for pesticide labeling under FIFRA. CPDA and the other groups objected that the Proposition 65 warning requirement on a FIFRA-registered product would contradict EPA approved precautionary language and use directions. Moreover, this requirement could serve as a precedent for other states to follow thereby leading to confusion not only within industry, but for consumers and state regulators as well. CPDA continues to work with its allied trade association partners to resolve the dilemma that would be created under the pending Proposition 65 product label warning requirements.

 

  • CPDA continues to collaborate with Washington State Department of Agriculture (WSDA) regulators in expressing the serious concerns of its member companies with the department’s notice to adjuvant registrants regarding inert ingredient disclosure. CPDA has objected that the increased specificity would compromise the identity of many products that adjuvant producers sell.

 

  • In June 2018, CPDA met with representatives of EPA’s Office of Pesticide Programs (OPP) to discuss reports received from member companies suggesting that the Agency is routinely failing to meet its PRIA timelines for the review of inert ingredient submissions despite EPA’s assertion to the contrary. CPDA remains fully engaged on this issue and continues to solicit member feedback on their experience with the registration process. The goal is presenting a set of final recommendations to the Agency aimed at facilitating the timely review of inert ingredient applications and reducing the number of renegotiations that are taking place with apparently increased frequency.

 

These are just a few examples of what CPDA is doing on behalf of its members whose businesses are aligned with one or more of the three industry segments described here.  Our goal is to focus on issues and policy germane to our members while collaborating with aligned associations to have a powerful, consistent message to the agencies.

As we strive to effectively advance our industry’s mission and ensure critical regulatory and legislative policies are science based and equitable, we seek to recruit and retain a critical mass of companies looking to succeed in the U.S. agricultural chemical marketplace.  To ensure your voice is heard during the development of new public policy and when current public policy threatens the economic success and viability of your company and the industry, we need your continuing support and the support of others as the resource base for the Council’s work.  Participation and involvement of our members is the bedrock upon which we build our advocacy efforts – whether in the halls of Congress, with key federal and state agencies, or through collaborations with allied partners in the agrotechnology industry.

 

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