Monthly Archives :

March 2019

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March 7, 2019, the period during which PRIA 3 had lapsed and fees were reduced by 70% and the statutory timelines were no longer in effect. Those applications may be withdrawn and then resubmitted with the new PRIA 4 fee.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