Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Lisa R. Burchi


On March 1, 2015, the U.S. Environmental Protection Agency (EPA) released the 11th Annual Report on EPA’s implementation of the Pesticide Registration Improvement Extension Act (PRIA 3) that is required under Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

This annual report details changes in processes, practices, and policies for Fiscal Year (FY) 2014 that ran from October 1, 2013, through September 30, 2014. The report is divided into different sections related to: (1) pesticide registration service fees; (2) maintenance fees; and (3) process improvements in the pesticide program; all of which can be accessed on EPA’s website at the below links. Specifically, the report covers the following topics:

Pesticide Registration Service Fees
* Fees Collected, Waived, Exempted and Expended
* Accomplishments
        o Pesticide Worker Protection
        o Partnership Grants
        o Progress in Meeting Decision Times

Maintenance Fees
* Fees Collected and Expended
* Accomplishments
        o Inerts
        o Expedited Processing FIFRA Section 3(c)(3)(B)
        o Pesticide Reevaluation Programs

Process Improvements in the Pesticide Program
* Registration
* Pesticide Reevaluation Programs
* Information Technology and Labeling
* Science Review/Assessment Improvements

EPA’s report addressing process improvements in the pesticide program discusses several areas where EPA believes its registration programs have improved, either through increased efficiency, consistency, and/or transparency. The areas discussed are:

* EPA’s use of the “Lean” business model to improve business processes;

* Delegation of authority to EPA’s Biopesticides and Pollution Prevention Division (BPPD) to expedite fast track and notification actions to reduce approval times and the number of actions in backlog status;

* Biopesticide Industry Alliance Registration Workshops to improve quality of application submissions;

* Release of testing guidelines to clarify scenarios under which efficacy testing at the lower certified limit is needed;

* Reduction of registered products for which EPA is taking action under the Antimicrobial Testing Program;

* Continued crop grouping regulations to save resources and reduce the number of required residue studies;

* Establishment of a Pre-decisional Determination Due Date to provide adequate time to reach agreement with the registrant on required label changes prior to EPA approving the label; and

* International work sharing to assist in individual country registration decisions while striving to harmonize regulatory decisions with global partners.


With regard to EPA’s review of electronic labels, EPA states the following:

1. Of approximately 6,300 labels submitted to EPA in FY 2014, almost half included an electronic label. Comparing the statistics from FY 2011 to FY 2014 reveals a steady increase of approximately 10 percent each year in the percentage of labels submitted in electronic format.

2. The use of electronic label review software varies significantly across the three regulatory divisions with the Registration Division reporting the highest use, the Antimicrobials Division reporting moderate use, and BPPD the lowest use.

PRIA 3 is effective from October 1, 2013, through September 30, 2017.
 


 

By Sheryl Lindros Dolan

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


 

By Sheryl Lindros Dolan

On September 30, 2014, the U.S. Environmental Protection Agency (EPA) redesigned the Pesticide Registration Improvement Extension Act of 2012 (PRIA 3) website. The new website is available at www2.epa.gov/pria-fees. The purpose of the redesign is to make PRIA 3 information more easily accessible to stakeholders and the public, regardless of the type of device being used. EPA made no technical or regulatory changes to PRIA 3.


 
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