Posts By :

Diane Schute

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March 7, 2019, the period during which PRIA 3 had lapsed and fees were reduced by 70% and the statutory timelines were no longer in effect. Those applications may be withdrawn and then resubmitted with the new PRIA 4 fee.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.

Reauthorization of PRIA Close to Enactment

On the evening of Monday, February 25th, the House passed a long-term PRIA reauthorization bill (PRIA 4) under unanimous consent. Previously, on February 14, 2019, the Senate passed by voice vote S. 483, a stand-alone bill introduced on February 13th to reauthorize PRIA.  S. 483 does not contain the full legislative text adopted by the House on February 25th but instead references H.R. 1029, the Pesticide Registration Enhancement Act, as amended by the Senate on June 28, 2018 during the last Congress. The Senate is expected to approve the legislation recently adopted by the House which contains the full text rather than just a reference to the June 2018 Senate passed bill. This is described as a parliamentary procedure that does not affect the substance or intent of the PRIA reauthorizing legislation passed by both chambers of Congress.

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 passed both the House and Senate and is near enactment into law.

PRIA Reauthorization Language Not Retained in Farm Bill Conference Report

On Monday, December 10th, House and Senate Agriculture Committee Chairmen Mike Conaway (R-TX) and Pat Roberts (R-KS) and Ranking Members Collin Peterson (D-MN) and Debbie Stabenow (D-MI) filed the conference report to accompany H.R. 2, the “Agriculture Improvement Act of 2018,” also known as the Farm Bill. The long-awaited measure was passed by the Senate on December 11th by a vote of 87 to 13 and was then sent to the House where it was adopted on December 12th by a vote of 369 to 47.  The President is expected to sign the measure into law this week.

Two add on bills strongly supported by CPDA and its allied industry partners unfortunately were not included in the final Farm Bill conference report – namely, language that would establish a long-term reauthorization of PRIA and provisions that would eliminate the duplicative National Pollutant Discharge Elimination System (NPDES) permitting requirement for FIFRA registered pesticides. The conference report does, however, include several pesticide related provisions of interest as briefly described below.

Among these is a provision that directs the USDA Secretary, acting through the Director of the USDA Office of Pest Management Policy, to conduct a multiple crop and pesticide use survey of farmers to collect data for risk assessment modeling and mitigation for an active ingredient. 

The conference report also calls for the establishment of a FIFRA Interagency Working Group to provide recommendations and develop a strategy for improving the pesticide consultation process under Section 7 of the Endangered Species Act (ESA). This working group will consist of representatives from the Department of Agriculture, the Department of Commerce, the Department of the Interior, the Council on Environmental Quality, and the Environmental Protection Agency. The working group will be required to periodically report to the House and Senate Agriculture Committees on its progress in developing and implementing its recommendations for improving the ESA Section 7 consultation process.

In its other provisions, the conference report includes language on plant biostimulants requiring the USDA Secretary, in consultation with the Administrator of the EPA, States, and relevant stakeholders, to provide a report to Congress that identifies “any potential regulatory, non-regulatory, and legislative recommendations, including the appropriateness of any definitions for plant biostimulants.” The conference report defines “plant biostimulant” as a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield. The conference report language allows the Secretary to modify the description of plant biostimulant, as appropriate. The conference report managers cite the importance of plant biostimulants as “an emerging technology for production agriculture” and state that the report will “facilitate the regulatory framework for plant biostimulant products and ensure the efficient and appropriate review, approval, uniform national labeling, and availability of these products to agricultural producers.” The Farm Bill conference report may be accessed by clicking here.

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. 

Fall 2018 EPA Regulatory Agenda Includes Pesticide Activities

On October 17, 2018, the Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions and Regulatory Plan was released by the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs. The Regulatory Agenda is a listing of all the regulations that federal agencies and Departments expect to have under active consideration for promulgation, proposal, or review during the coming six to 12-month period.

Included in the Regulatory Agenda is EPA’s plan to issue a final regulation rescinding the 2015 “waters of the United States” rule by March 2019. In other listed actions, EPA intends to issue a final rule in September 2019 on changes to requirements contained in the Agricultural Worker Protection Standard (WPS) related to minimum age, application exclusion zones (AEZ), entry restrictions for enclosed space production, and other revisions. The Agency is also proposing to amend its Certification of Pesticide Applicators rule by revising the minimum age requirements for individuals certified to use Restricted Use Pesticides (RUPs) and for non-certified individuals who use RUPs under the supervision of a certified applicator. EPA expects to issue a final rule in September 2019.

EPA has also been revising the current pesticide crop grouping regulations to create new crop groupings, add new subgroups, and expand existing crop groups with the addition of new commodities. The current crop groupings allow EPA to establish pesticide tolerances for multiple related crops based upon data for a representative set of crops. The Agency states that these revisions will promote greater use of crop grouping for tolerance-setting purposes and will facilitate the availability of pesticides for minor crop uses. EPA finalized the fourth phase of its crop grouping revisions in May 2016 and is planning to propose a fifth phase by February 2019 and then a sixth phase by June 2019.

In other activities, EPA is considering changes to several procedural regulations that require the publication of a notice in the Federal Register for purposes of providing information on the registration of a pesticide product with a new active ingredient or new use; the approval of specific quarantine and public health exemptions; and summaries of certain state registrations. Rather than announcing the availability of such information through publication of a Federal Register notice, EPA plans to develop a consolidated website for posting such information. EPA states that this will be a more cost effective and efficient mechanism for sharing such information with the public.

Farm Bill Deliberations Remain Stalled Heading into Mid-Terms

As reported previously, negotiations on the Farm Bill remain stalled due to non-PRIA related matters including differences in proposed changes to the Supplemental Nutrition Assistance Program as contained in the individually passed House and Senate measures. Meanwhile, EPA’s authority to collect the full level of registration service fees under existing PRIA 3 has been extended through December 7, 2018 as part of a Continuing Resolution that was signed into law on September 28th.

Industry and agricultural interests continue to work in the hopes that consensus on a final Farm Bill, including a permanent reauthorization of PRIA, can be reached in the lame duck session of Congress following the mid-terms. However, there is growing concern that the outcome of the mid-terms, specifically as related to whether Democrats take control of the House, could significantly impact the prospects for passage of a compromise Farm Bill during the lame duck. According to political observers, 72 seats in the House remain in contention with some 50 “on the bubble.” Should the 115th Congress adjourn at the end of this year leaving the Farm Bill unfinished, it is possible that a Democrat controlled House in the next Congress could decide to rewrite a Farm Bill in its entirety thus adding further uncertainty to the likelihood of securing a permanent reauthorization of PRIA this year. It is expected that lobbying efforts will intensify very quickly after the mid-terms with the goal of achieving passage and enactment of a final Farm Bill in 2018.

Meanwhile, the CEOs of a broad coalition of agricultural interests, collectively known as the Ag CEO Council, met recently to discuss the status of deliberations over the Farm Bill and PRIA reauthorization. On October 18th, the group sent a letter to the majority and minority leadership of the House and Senate Agriculture Committees emphasizing the importance of passing a final Farm Bill by the end of this year. Members of the CEO Council explained that finalizing the 2018 Farm Bill will ensure policies that support food safety, production agriculture, environmental quality, crop insurance, animal disease prevention, conservation, research, renewable energy, and new foreign market access. The letter pointed out that agricultural producers need the certainty provided by a long-term reauthorization of the Farm Bill. The CEO Council also wrote to Senate Majority Leader Mitch McConnell, Senate Minority Leader Chuck Schumer, Speaker of the House Paul Ryan, and House Minority Leader Nancy Pelosi urging Congressional leadership to work with Agriculture Committee conferees in an effort to complete the Farm Bill in the closing days of the 115th Congress.

CPDA will continue to keep its membership informed of further developments on PRIA and the Farm Bill as they occur.

CPDA Engages with WSDA in Calling for an Expedient Process that would Allow Alternatives to BIT in Adjuvant Formulations

In related activities surrounding the shortage of BIT, CPDA has been engaged with the Washington State Department of Agriculture (WSDA) in calling for guidance that would set forth a streamlined process allowing registrants of spray adjuvants to substitute alternative preservatives in their products. In a request sent to WSDA’s Registration and Licensing Services Program on September 18th, CPDA Interim President Gary Halvorson emphasized that the BIT shortage is not likely to abate any time soon and he requested that the Department move quickly in providing instructions for the modification of adjuvant registrations of existing formulations.

WSDA in response has specified three steps that registrants are required to take if they choose to revise their adjuvant formulations:

  1. Determine the appropriate revisions to the adjuvant CSF, based on the preservative use limits in 40 CFR 180.910 or .920 (assuming the adjuvant is intended for use on food or feed crops).
  2. Submit a revised adjuvant CSF to WSDA using the secure pesticide registration portal (https://agr.wa.gov/PestFert/Pesticides/ProductRegistration.aspx#Secure), and mention in the “Notes” box that the only change is the preservative. Do not submit a CSF by email, since this method is not secure.
  3. Contact the assigned Registration Specialist (https://agr.wa.gov/PestFert/Pesticides/ProductRegistration.aspx#RegContacts) and let them know that the registrant is submitting a revised adjuvant CSF.

WSDA has instructed that in lieu of these actions, a revised CSF can be submitted by ground mail or fax. The registrant should include a cover letter explaining that the only change is the preservative in such cases.