First Annual Report on EPA Actions Implementing the Pesticide Registration Improvement Act - Fiscal Year 2004
The Consolidated Appropriations Act of 2004, signed by President Bush on January 23, 2004, established a new section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which creates a registration service fee system for applications for specified pesticide registration, amended registration, and associated tolerance actions. Under this new system, fees are charged for covered applications received on or after March 23, 2004, and for certain pending applications received before that date. EPA is required to make a determination on the application within the decision times specified. The fee system is authorized until September 30, 2010, although the decision times under the system do not apply to applications received after September 30, 2008. This new system is known as the Pesticide Registration Improvement Act of 2003 (PRIA).
Under section 33(k) of PRIA, the Agency is required to publish an annual report describing actions taken under this section during the past fiscal year. Specifically, the Agency is directed to include several elements in the report, including a review of the progress made in carrying out its obligations under the Act, a description of the staffing and resources related to the costs associated with the review and decision-making pertaining to applications, and a review of its progress in meeting the reregistration and tolerance reassessment timeline requirements. This first annual report will cover the time period from January 23, 2004, through September 30, 2004.
On this page:
- Early Implementation Efforts
- Financial Overview
- Progress in Meeting Decision Times
- Process Improvements in the Registration Program
- Progress in Meeting Tolerance Reassessment and Food Use Reregistration Timelines
- Other Considerations
- Appendix A: Decision Review Types for Actions Completed During FY2004
The President’s approval of the Consolidated Appropriations Act of 2004 triggered a 60-day implementation period for EPA prior to the effective date of PRIA (March 23, 2004). During this 60-day period, the Agency undertook a number of steps to implement PRIA. Those steps are described in this section of the annual report. The Agency’s first step was to create a number of intra-Agency workgroups to develop recommendations for certain aspects of the new registration systems. Committees established included: front-end processing and screening procedures; waivers and refunds; funds management; and communications.
Front-End Processing and Screening Procedures
To facilitate the implementation of PRIA, the Agency established new front-end screening procedures for new pesticide applications. Interpretations of the 90 PRIA registration categories were developed by an intra-agency workgroup composed of staff from the Office of Pesticide Programs and the Office of General Counsel. Preliminary interpretations were published on the Agency’s website on March 22, 2004. As the Agency gains experience with the application of these interpretations to incoming registration requests, the Agency intends to publish updates on its website (http://www.epa.gov/pesticides/fees/categories/index.htm). Expert teams from the three registering divisions (Antimicrobials Division, Biopesticides and Pollution Prevention Division, and Registration Division) have been established to screen all incoming applications, to determine if the request is subject to PRIA, and to assign the application to a PRIA category (if appropriate). Typically within 48-72 hours from receipt of the application, the registrant is sent an invoice requesting payment of the appropriate PRIA registration service fee. The Agency’s internal tracking system, known as the Office of Pesticide Programs Information Network (OPPIN), was re-tooled to track all PRIA applications to ensure compliance with the PRIA decision time review periods. The Agency also enhanced OPPIN to mail invoices electronically to applicants.
In addition, the Agency revised its procedures for the initial screening
of all data submitted to the Agency by registrants. With the new PRIA
resources, the Agency enhanced its existing data management contract to
reduce the study processing time to 10 days. This step now ensures that
complete data packages are ready to enter the review process at the beginning
of the specified decision time review period if the applicant has correctly
formatted the data submission.
Funds Management/Funds Utilization
Section 33(c) of PRIA established the Pesticide Registration Fund. Congress established this fund in the Treasury of the United States to carry out the provisions of PRIA. All registration service fees received by the Agency are deposited in this fund. Expenditures from the fund can be made to cover the costs associated with the review and decision-making pertaining to all applications for which registration service fees have been paid. To facilitate the creation of this Fund, the Agency worked with the Mellon Bank to establish the fund, create billing procedures, and coordinate communications on fee receipts between the Bank and the Agency. This latter piece was particularly critical as the fee payment receipt triggers the start of decision time review period.
Waivers and Fee Reductions
Section 33(b)(7) of PRIA authorizes the Agency to reduce or waive the applicable registration service fee under certain specified situations. The Agency developed guidance on how to apply for waivers of the registration service fee and posted them on its website (http://www.epa.gov/pesticides/fees/questions/waivers.htm) prior to the PRIA effective date. In addition, working with the Office of Management and Budget (OMB), the Agency was granted an emergency clearance under the Paperwork Reduction Act (PRA) to collect the necessary information from pesticide applicants to support the fee waiver program. The Agency established a cross-Agency team, composed of members from the Office of Pesticide Programs, the Office of General Counsel, and the Office of Small and Disadvantaged Business Utilization, to review all incoming fee waiver requests.
In addition, working with the Inter-regional Project Number 4 (IR-4 Program), the Agency established procedures for reviewing IR-4 waiver requests. The IR-4 Program agreed to take on an enhanced coordination function, streamlining the submission of tolerance petitions and registration applications for IR-4-supported applications. This new process has facilitated swifter reviews of fee waiver requests under the IR-4 waiver provisions.
The Agency also established formulae for reducing certain registration service fees based upon work completed by the Agency prior to the PRIA effective date. Section 33(b)(8)(C) authorizes the Agency to issue discretionary refunds, including in instances where the Agency had completed portions of the review of an application before the PRIA effective date. For fees required of pending new active ingredients and for applications for which the registrant identified a willingness to voluntarily pay the registration service fee, the Agency applied this refund provision as a credit towards the application registration service fee. The fee reduction formulae can be found at: in the (PRIA 3): Overview of Fee Reduction and Refund Formula (PDF) (7 p 369.16). During Fiscal Year 2004, the Agency reduced $3.7 million in registration service fees based upon work completed by the Agency on pending applications prior to the PRIA effective date.
Communications and Outreach
On March 11, 2004, the Agency held a workshop to educate affected stakeholders and the public on PRIA implementation and impacts. This workshop was attended by nearly 500 people. Topics ranged from an overview of the new statute, revised application submission procedures, guidance on the review of waivers, and the Agency’s initial considerations for how to allocate resources from the Pesticide Registration Fund to the worker protection program and the inert ingredients review program. The Agency’s presentations can be found on the EPA website at: http://www.epa.gov/pesticides/fees/index.htm.
As required by the statute, on March 17, 2004, the Agency published the schedule of covered applications and registration service fees. In addition, since the statute suspended the Agency’s authority to collect tolerance petition fees, the Agency issued a final rule on March 17, 2004, suspending the tolerance petition fee collection regulations.
The Agency also established a website dedicated solely to PRIA implementation. The site is http://www.epa.gov/pesticides/fees. Through this website, the public can submit questions regarding PRIA implementation. Questions are typically answered within 24 hours.
Financial OverviewDuring fiscal year 2004, the Agency received $14.7 million in new registration service fees. From these new fees, the Agency spent approximately $5 million, carrying the remaining balance of $9.7 million forward to fiscal year 2005. The chart below summarizes the Agency’s FY2004 expenditures from the Pesticide Registration Fund (figures presented are in thousands):
The majority of the expenditures from the Pesticide Registration Fund were spent on payroll costs and to expand data review output through contracts. The Agency also invested heavily in upgrading its information management system (the Office of Pesticide Programs Information Network) to be able to track compliance with the PRIA decision time review periods.
Waivers of Registration Service Fees
In response to requests for fee waivers and fee reductions, as authorized by PRIA, the Agency waived $1.5 million in registration service fees. The Agency reviewed over 200 waiver requests, granting over 85 percent of the waivers requested. Agency decisions to grant waivers were reviewed, on average, in 52 days. Agency decisions to deny waiver requests were reviewed, on average, in 67 days, slightly above the PRIA standard of 60 days. Since the end of fiscal year 2004, the Agency has revised its internal procedures to ensure that waiver decisions are always made within the 60-day statutory review period.
Number of PRIA Actions Completed in FY2004
The Agency completed 208 decisions subject to PRIA during the fiscal year. All decisions were made within the statutorily-mandated decision review times. The chart below summarizes the number of decisions completed by PRIA category.
Progress in Meeting Decision Times area
Number of PRIA Applications Completed in FY2004
The following table summarizes the number of pending registration applications in each of the PRIA categories. As of September 30, 2004, 1,081 applications subject to PRIA were pending in the Agency’s registration queue.
Number of PRIA Applications Pending at the End of FY2004
Pending Inert Ingredients at the End of FY2004
PRIA section 33(k)(2)(A)(ii) also requires the Agency to provide the number of inert ingredients pending review by the Agency. As of September 30, 2004, the Agency had 44 petitions for new inert ingredients (37 received prior to the PRIA effective date and 7 received subsequently)
Section 33(e) of PRIA directs the Agency to identify and evaluate reforms to the pesticide registration process, with the goal of reducing decision reviews times for pesticide registration applications. The Agency has made considerable progress during the fiscal year in improving its operations. It has undertaken a number of steps, both internal and external, to explore, develop, and implement improvements in the registration process.
In identifying process improvements, the Agency will not compromise the scientific quality of its assessments as a means towards reducing decision time review periods. The Agency believes that, in terms of receiving recommendations for process improvements, the best means of gathering together suggested improvement areas was through the Federal Advisory Committee Act (FACA) process.
Formation of a Process Improvement Workgroup
A major effort during FY2004 was the creation of a new workgroup under the auspices of the Pesticide Program Dialogue Committee to evaluate process improvements in the registration program. This Process Improvement Workgroup is composed of members of individual registrant companies, pesticide trade associations, public interest groups, and Agency staff. Meetings are open to the public and are held approximately every 3-4 months. The first meeting of the Process Improvement Workgroup was held in August 2004. Reports from these meetings can be found on the Agency’s website at: http://www.epa.gov/oppfead1/cb/ppdc/pria/index.html.
Industry stakeholders identified many areas for improvement in the registration process, ranging from in-processing of applications, how applications should be reviewed, and the involvement of the registrants in the decision-making process. Many of the process improvements proposed by the Agency complemented these issues. The Agency continues to work with all stakeholders to evaluate these and other potential improvements to the registration process.
Process Improvements Implemented within the Registration Program
A key process improvement has been improved coordination between EPA and the IR-4 Program. Historically, the registration application to add a new IR-4 supported use to a label has not been submitted simultaneously with the IR-4 tolerance petition. Often times, the label request has arrived several months to years after the IR-4 tolerance petition has been submitted to the Agency. This delay in the label submission ultimately affects the Agency’s ability to act on the tolerance petition submitted by IR-4 in a timely manner. The IR-4 program volunteered to perform a new coordination function in which they will submit the registration request on behalf of the registrant simultaneously with the IR-4 tolerance petition. This coordinated submission will ensure the timely start of the decision time review period under PRIA and will give minor use growers greater predictability of when to anticipate a registration decision.
Scoping is the process of examining and often re-examining the specific action to determine what specific work is required to complete the action. Another aspect of scoping is determining how this work can be completed in the most efficient manner possible and defining a schedule for the action based on this determination. The Agency has begun to use existing alternative processes – the low toxicity screening group and the Alternative Risk Integration and Assessment (ARIA) Team –to think of new and innovative ways to review registration requests more efficiently. The Agency’s scientific organizations have also begun scoping exercises, such as problem formulation and risk tiering, to evaluate new registration submissions.
The Biopesticides and Pollution Prevention Division (BPPD) created a service, known as email@example.com, to respond to issues concerning Biopesticide registration inconsistency that affect processing of submissions. The Division’s biopesticide Regulatory Action Leaders (RALs) meet on a regular basis to discuss issues raised through this service and provide an answer usually within two to three weeks. BPPD posts the resolution of issues at: http://www.epa.gov/pesticides/biopesticides/.
During Fiscal Year 2004, the Agency made significant progress in completing risk assessments and risk management decisions for pesticide reregistration. The Agency completed 17 Reregistration Eligibility Decisions (REDs). During Fiscal Year 2004, the Agency issued tolerance reassessment eligibility decisions (TREDs) for 18 active ingredients and 8 pesticide inert ingredients. These decisions resulted in the completion of 467 tolerance reassessments
Status of Reregistration
Through the end of FY2004, the Agency has completed 244 REDs and must issue 137 more REDs to complete reregistration by the end of FY2008. EPA’s goal is to complete 30-40 reregistration eligibility decisions each year during fiscal years 2005 and 2006 for pesticides with associated tolerances, and to complete a total of 40 REDs in FY2007 and FY2008 for pesticides with no food uses or tolerances. This will satisfy PRIA requirements and support the Agency’s tolerance reassessment and reregistration goals. EPA’s schedule for completing these decisions can be found on the Agency’s website at: http://www.epa.gov/pesticides/reregistration/product-rereg-schedule.htm.
Status of Tolerance Reassessment
Through the end of FY2004, the Agency has completed a total of 7,092 tolerance reassessment decisions to date, addressing 73% of the 9,721 tolerances that require reassessment. EPA is accomplishing tolerance reassessment through both the registration and reregistration programs; by revoking tolerances for pesticides that have been canceled, by reevaluating pesticides with pre-FQPA REDs, and through other decisions not directly related to reregistration or registration.
More specifics on the Agency’s progress in meeting its performance measures and goals for pesticide reregistration will be published in the Federal Register, as required by section 4(l) of FIFRA.
Use of Outside Reviewers
During the course of FY2004, the Agency explored mechanisms for enhancing its work share efforts with Canada’s Pest Management Regulatory Agency (PMRA) and the California Department of Pesticide Regulation (CDPR). Currently, there are 6 active ingredients being jointly evaluated by the EPA and PMRA as part of the Joint Review Program under the North American Free Trade Agreement. Through this process, EPA makes its own registration decision.
In further exploration of the use of outside reviewers, during fiscal year 2004, EPA worked with CDPR to expand their capacity to review residue chemistry studies and conduct dietary risk assessments in support of registration decisions. During FY2004, 11 crop combinations were reviewed through this joint effort. In addition, the two agencies collaboratively reviewed two new biopesticide active ingredients during FY2004.
In addition, during FY2004, the Agency detailed a senior manager to the Pesticides Section, Health and Consumer Protection Directorate, European Commission (EC) to build on the existing work sharing activities and lines of communication between EPA and the EC. Areas of focus included facilitating the exchange of risk assessments and advancing the sharing of workload between EPA and the EC to achieve more consistency in pesticide regulatory decisions for the registration and reregistration of pesticides, evaluation and registration of new active ingredients, guidelines on methodologies used in evaluations, and activities involving inert ingredients.
In March 2004, the Office of Pesticide Programs solicited proposals from other program offices within the Agency that might want enhanced funding to support the Agency’s PRIA implementation efforts. The Office requested that other programs submit proposals describing the additional services that could be provided to assist in providing enhanced registration services, the resources necessary to provide these additional services, and a description of the performance measures that could be implemented to monitor the provision of these services.
In response, the Office of Pesticide Programs entered into a memorandum of understanding (MOU) with the Agency’s Office of Acquisition Management (OAM) to award, modify, and initiate contract actions in support of PRIA. OAM agreed to negotiate accelerated performance agreements with contractors within 30 days; exercise additional quantities options with 48 hours of request, among other considerations, while maintaining the existing contract performance standards in place before PRIA passed. OAM agreed to submit bi-weekly monitoring reports to OPP. For provision of these enhanced services, the Agency allocated OAM one full-time equivalent (FTE) from resources supporting PRIA.
A second area under PRIA where the Agency has employed the use of performance-based contracts is in the area of processing and indexing support for studies and other technical documents submitted in support of registration decisions. Utilizing resources from the Pesticide Registration Fund, the Agency increased contract funding to lower the average study processing time from 20 days to 10 days. Through a combination of hiring new staff and the learning curve for the new hires, it took a few months to meet the new turnaround time for all data. Since August 1, 2004, the contractor has consistently met the accelerated processing schedule for all new incoming data. From August 1, 2004 to January 28, 2005 the Agency received 2,110 studies subject to PRIA. The contractor was able to process these studies, on average, within 1.84 days. Through this effort, technical evaluators have more time to review the scientific information submitted in support of registration applications, ensuring a higher quality technical assessment.
As required by Section 33(k) of PRIA, the following table provides the decision times for each application reviewed during Fiscal Year 2004. Note that negative decision times indicate that the Agency completed the action before it received payment or a waiver was granted. Completion of a registration action before payment is received typically occurs in situations where a voluntary fee payment has been offered for an application that was pending with the Agency prior to March 23, 2004 (the PRIA effective date). As EPA improves its reporting capabilities, the Agency reserves the right to update this completions table, as necessary.
Key to the Table
M = New Active Ingredient application subject to the mandatory fee provisions
N = Application received on or after March 23, 2004
V = Voluntary payment request
|PRIA Code||Type||Decision Number||Registration Number||PRIA Start Date||PRIA Due Date||Agency Completion Date||Decision Time (in days)|