Detailed Information on the
Pesticide Registration Assessment

The pesticide programs were restructured to match the 2011 Strategic Plan and the current PARTs programs do not exist. The pesticide program is now waiting a rePART to align the PART programs with the current budget and Strategic architecture.

The Administration recommends maintaining funding at the 2004 President's Budget level adjusted for the annual pay increase.

The program will develop long-term risk-based outcome performance measures that will supplement the existing long-term measures.

Implement new strategic plan architecture into FY 08 management activities and day-to-day operations.

The program will also work on long-term outcome efficiency measures.

Establish executive leads to provide senior leadership for each of the 3 mission areas in the new Strategic Plan.

Brief staff on new Strategic Plan in order to incorporate stronger alignment between Strategic Plan individual Performance Agreement and Recognition System (PARS) agreements.

Executive leads working toward the development and refinement of meaningful outcome oriented measures for each of the three mission area in the new Strategic Plan

Independent assessment of the performance measures improvement project by the Federal Consulting Group.

Measure: Percentage of agricultural acres treated with reduced-risk pesticides

Explanation:Indirectly measures the increase in registration of pesticides that are lower risk than conventional pesticides by measuring the use, availibility, and effectiveness (demand) for them. The FY05 results exceeded the targets for FY 05-FY 08 due to an unanticipated use of reduced risk pesticides.

Measure: Percent reduction in review time for registration of conventional pesticides.

Explanation:Measures reduction in decision-making time for new active ingredient registration actions from a 2002 baseline. The 2005 target was not met due to an increased decision time from 44 months to 47 months for triazole.

Measure: Percent of agricultural watersheds that exceed EPA aquatic life benchmarks for two key pesticides.

Explanation:By 2011, program plans to reduce by 60% the number of agricultural watersheds sampled that exceed aquatic life benchmarks for two key pesticides (azinphos-methyl and chlorpyrifos). Baseline is derived from the USGS National Water-Quality Assessment (NAWQA) program's 2006 report are as follows: Azinphos-methyl: 18% of 83 agricultural watersheds sampled exceeded; Chlorpyrifos Baseline: 18% of 83 agricultural watersheds sampled exceeded

Measure: Percent of urban watersheds that exceed EPA aquatic life benchmarks for three key pesticides of concern.

Explanation:By 2011, program plans to reduce by 60% the number of urban watersheds sampled by the USGS National Water-Quality Assessment (NAWQA) program that exceed the National Pesticide Program aquatic life benchmarks for three key pesticides of concern (diazinon, chlorpyrifos, malathion). Baseline is derived from the USGS National Water-Quality Assessment (NAWQA) program's 2006 report are as follows: Diazinon Baseline: 40% of 30 urban watersheds sampled exceeded; Chlorpyrifos Baseline: 37% of 30 urban watersheds sampled exceeded;

Is the program purpose clear?

Explanation: Statute authorizes the registration of pesticides to prevent unreasonable risks to human health and the environment, to consider pesticide efficacy where appropriate, to promote availability, and to expedite reduced risk pesticides. Thus, the program has a succinct, defensible purpose: To ensure safe and effective pest control options are available.

Evidence: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Sections 3(a), 3(c)(5), 3(c)(10)(B).

Does the program address a specific and existing problem, interest, or need?

Explanation: Pesticides and herbicides are essential tools for controlling insects, weeds, bacteria, and other pests in agriculture, hospitals, homes and gardens. Though essential, pesticides by nature are designed to be harmful to certain organisms. The registration of pesticides ensures they meet certain science-based safety and efficacy standards before they can be sold. The program also considers the current pesticide needs and the range of available pesticides that meet the needs where appropriate in addressing certain aspects of registration decisions. Pesticide registration is an ongoing need because develop resistance to existing pesticides and new pest problems arise over time. Also because manufacturers continuously develop new technologies and new methodologies to address these issues and to provide more effective or less costly pest control options.

Evidence: EPA typically receives 10-15 petitions for new pesticide active ingredients and an average of 250 new use requests each year. These represent only a subset of the total registration actions the program must complete. According to a USDA report, farmers receive $1-3 return for every dollar spent on pesticides and without just one class of pesticides, carrot production would drop by 48%, tomatoes by 36%, strawberries by 30% and cotton by 27%. (USDA publication Production Practices for Major Crops in U.S. Agriculture, 1990-1997). Based on an EPA analysis, without a certain subset of Section 18 pesticides (emergency exemptions), the U.S. could have experienced approximately $1.2 billion in crop losses. (Sect 18 using IR-4 data, 88-01)

Is the program designed so that it is not redundant or duplicative of any Federal, state, local or private effort?

Explanation: This program is the sole nationwide pesticide registration authority and thus, it is the only program addressing this specific purpose and specific need. It is essential that registration occur on the national level because of the lack of resources at the State level and the need to ensure national consistency in worker and human health protection. Some States do have registration programs but they are not consistent and none supplant EPA's registration.

Evidence: FIFRA Section 3(a), 3(c)(5), 3(c)(10)(B).

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: The program is free from major flaws that limit effectiveness or efficiency. The program targets reduced risk pesticides for quicker review action, creating incentives for industry to design safer pesticides. The program is able to request additional data when needed from industry. Food Quality Protection Act requirements provide a good balance of specific risk reviews and implementation flexibility to meet national and changing needs. Program is oriented to improving efficiency, witness section 18 process, other improvements. Without the program, significantly more toxic pesticides would be in use. No evidence is available which shows that a better mechanism exists. Though no major flaws have been identified, backlogs do exist in some areas.

Evidence: FIFRA data call-in authorities; FQPA science policies; reduced risk pesticides guidelines; homeland security decontamination needs implemented through this program.

Is the program effectively targeted, so program resources reach intended beneficiaries and/or otherwise address the program's purpose directly?

Explanation: The registration program uses a priority system to ensure that the program is effectively targeted, so that resources will reach intended beneficiaries and/or otherwise address the programs purpose directly. The registration priority system places high priority on registering pesticides that are safer than pesticides currently on the market, pesticides with public health benefits, and pesticides that are of particular economic importance to producers. The program has the authority to charge fees to cover part of the cost of the program but has be blocked from doing so by Congressional action through the appropriations process. Collection of these fees would put the responsibility for paying for part of this program on the registrants who receive the direct benefits of registering pesticides.

Evidence: Pesticide registration notices 97-2 and 98-7, available online at www.epa.gov/pr_notices/

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: The program has included two long-term indicator goals that focus on outcomes related to the program activities. They are overarching goals measuring health and environmental conditions which are impacted by all OPP activities as well as activities that are beyond the control of the program or the agency. The exact level of contribution from specific program actions can not be determined but it is reasonable to assume that progress on OPP activities will contribute positively to these indicators. OPP has agreed to develop, over the course of the next year, long-term risk-based goals to quantify reduced exposure to toxic pesticides which will more specifically and directly and measure the human health and environmental benefits of the program actions. The program will also work on a long-term outcome efficiency measure commensurate with their risk-based goals OMB is accepting the wildlife mortality incidence long-term goal as a low-level outcome but expects the agency to work to make this goal more directly reflect risk.

Evidence: EPA's FY 2003 Strategic Plan, Goal 4, objective 1. OPP has established an internal effort to review and improve their existing goals and has agreed to developing risk-based goals through this work. To support OPP's efforts to improve goals, EPA initiated a project to identify and evaluate new outcome results measures. The CAPRM project (Chemical and Pesticides Results Measures) project with Florida State University is currently in its second phase. Preliminary results from this effort were cited in the FY03 President's Budget.

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: OPP began monitoring progress on both of these long-term measures in FY 2003. Preliminary baselines and targets have been established for these long-term indicator goals but EPA indicated that revisions may be needed.

Evidence: EPA's FY 2003 Strategic Plan, Goal 4, objective 1. FY 2003 EPA Annual Report.

Does the program have a limited number of specific annual performance measures that demonstrate progress toward achieving the program's long-term measures?

Explanation: The Registration program has several annual measures that directly reflect program performance and are useful for program and resource management. These are output measures but are acceptable because it is a licensing program that results in "products" (registrations) - by completing registration actions, the program is directly addressing the needs established in Section I, Question 2: safety, effectiveness, availability. The program has also developed useful programmatic output efficiency measures that encourage increased productivity. OPP overall does need to work further on developing outcome efficiency measures that relate to the long-term measures of the program. And, risk-based annual goals may be needed commensurate with the long-term risk-based goals under development.

Evidence: FY 2003 EPA Annual Plan and Report (and prior years). Agency FY 2005 budget submission

Does the program have baselines and ambitious targets and timeframes for its annual measures?

Explanation: Outyear targets have not been provided for the registration program annual goals beyond 2005. EPA is working to further develop baselines and ambitious targets for its annual measures for the registration program. OPP is in the process of annualizing the draft baselines for submission of the Congressional Justification for FY 2005.

Evidence:  

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, etc.) commit to and work toward the annual and/or long-term goals of the program?

Explanation: Performance measures are written into the Statement of Work established as part of every contract and grant. These measures are tied directly to annual performance goals of the program. Deliverables, costs, and schedules are written Task Orders that outline expectations on a monthly basis. Monthly Surveillance Reports are submitted to the EPA and are reviewed by the Work Assignment Mgr who documents whether the performance is satisfactory.

Evidence: Statement of Work for each contract/grant, Monthly Surveillance Reports, Work Assignment Mgr reports (internal review documents).

Are independent and quality evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: No "independent" reviews have been done on the program as a whole regularly or otherwise. There are no structured, comprehensive reviews of the program performance. The program participates on many committees that provide input and guidance on both performance and process, but committees generally consist of potentially biased parties and the input is not always structured or managed within the agency. The Science Advisory Panel provides routine external peer feedback on the science analysis for many program decisions. OPP has started Mutual Accountability Assessments (MAAs) with its regional and state pesticide program partners to focus attention on the strengths and weaknesses of both regional and headquarters pesticide programs. MAAs are done jointly with our Office of Enforcement and Compliance Assistance and Office of General Counsel partners.

Evidence: OPP has contracted to complete study to determine what market share each of the conventional 'reduced-risk' pesticides has gained in their respective crops/sites. Reports for Mutual Accountability are produced per assessment, the latest of which is for Region 7, April 10, 2003. Contract Statement of work for Evaluation of Reduced Risk Pesticide Program. SAP website.

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: EPA has had their budget structure aligned with their GPRA goals for some time. For the registration program, funding changes can be translated directly into a change in the number of pesticide registration applications reviewed. The program completes and annual planning process through which they determine how many reviews they intend to complete the following fiscal year. The process includes a prioritization system for the petitions to be reviewed and involves balancing resource constraints and the program takes into account the full cost of operations.

Evidence: Annual budget submission to OMB and Congressional Justification show links between goals, appropriations and key programs. Office of Pesticides Programs (OPP) maintains a very useful, clear, detailed budget model that breaks the budget down further by linking all activities to the existing GPRA goal structure. Funding for the Registration program is one of several programs/activities within this model. OPP internal annual planning process involves balancing program work requirements and resource constraints.

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: The Office of Prevention, Pesticides and Toxic Substances (OPPTS) and the Office of Pesticides Programs (OPP) (which is an office within OPPTS) participates in the agency-wide process for reviewing and updating the agency strategic plan and develops or adjusts its goals and measures as part of this process. Strategic planning is done at the office rather than program level because OPP/OPPTS programs are in competition for resources and because a many programs are not totally independent of one another. OPP has made a commitment to further improve its long-term measures and has made progress in developing output efficiency measures for the Registration Program. Though internally-measured outputs are tracked and reviewed by management, OPPTS/OPP lacks a comprehensive system for tracking and retrieving information on planning decisions and does not have a thorough, defined process that centralizes external feedback on emerging issues and performance.

Evidence: EPA's FY 2003 Agency Strategic Plan, Goal 4, Objective 1. CAPRM reports; CARAT website; SAP website. Agency-wide Strategic Plan update every 5 years - coordinated by Office of the CFO.

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: The Program uses the new consolidated Office of Pesticides Programs Information Network (OPPIN) database system, which went on-line in 2003, to track information on the progress of registration activities and reports on the progress of activities are provided to Program management on a weekly and monthly basis. Division meetings to discuss work plan and performance and flag issues are held bi-weekly/monthly and quarterly. Resource reallocation (in terms of personnel effort) is done real-time. Branch level meetings occur weekly. Regular reviews of contractor performance are also performed. Additional information on process and performance is collected from stakeholders but this information is not reported on internally in a formal way. The program does not survey stakeholders to collect overall performance information from stakeholders. USDA, FDA and external commercial data are often used for performance measures and trend analysis.

Evidence: Office of Pesticide Programs Information Network (OPPIN) database used to track activity on products - stores history - easily retrievable. New Chemical and Use database for tracking actions on registration petitions over time. Examples of external sources of performance/process input: Pesticide Program Dialogue Committee (PPDC) and State FIFRA Issues Research and Evaluation Group (SFIREG). CAPRM report; USDA and FDA websites.

Are Federal managers and program partners (grantees, subgrantees, contractors, cost-sharing partners, etc.) held accountable for cost, schedule and performance results?

Explanation: All SES managers have program long-term and annual performance goals built into their personal performance plans and reviews. Contractors are held accountable for cost, schedule and performance through regular reviews.

Evidence: SES Performance Management System. Multiple options for ensuring contract accountability - delinquency notices, liquidated damages, warranties written into the contract.

Are all funds (Federal and partners') obligated in a timely manner and spent for the intended purpose?

Explanation: All funds are obligated in a timely manner and are aligned with statutory authorities and GPRA goals. The Assistant Administrator responsible for the registration program conducts program reviews twice a year and reviews obligations monthly. Grants/contracts plans are prepared in line with the program GPRA structure and the program follows agency grant and contracting policies and are updated as funds are executed. At the agency level (Chief Financial Officer), obligations and expenditures are tracked in the agency's Integrated Financial Management System and compared to the approved annual operating plan.

Evidence: Spreadsheet provided showing carryover 1999-2001. Periodic spending reports, Financial Status Reports, Grants & Contracts Status reports, Budget Accounting System (BAS) data, financial management directives.

Does the program have procedures (e.g., competitive sourcing/cost comparisons, IT improvements, approporaite incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: The program has now drafted several output efficiency measures that target reducing decision times for registration actions but the program must work to develop outcome measures that relate to the long-term outcome measures of the program. In 2003, OPP reached its Target Architecture for information systems by deploying the new Office of Pesticide Programs Information Network (OPPIN). This new system combines 19 independent data storage and tracking systems, reduces the time to locate documents and allows queries and analyses that were not possible before. It also helps improve quality control, and allows the risk manager to assemble information for review and/or develop regulatory documents more efficiently. OPP is participating in a competitive sourcing/cost comparison exercise under OMB's streamlined competitive sourcing guidelines.

Evidence: Draft Competitive sourcing document for Pesticide Programs. The program has already outsourced much of the base scientific review functions required for registration applications. IT initiatives are underway to streamline the registration label review process. Projections of cost savings associated with the use of OPPIN include hours of time saved from ability to analyze across data groups electronically and tracking data for registrations.

Does the program collaborate and coordinate effectively with related programs?

Explanation: The Registration program, under the auspices of the Office of Pesticides Programs at EPA, collaborates and coordinates with multiple Federal agencies, States, foreign governments, and private sector entities on a variety of issue specific and more general topics. These include a work share program with Canada which focuses on reviewing data for pesticide registrations to improve efficiency, partnerships with the CDC on responding to the West Nile virus and with many agencies on homeland security-related tasks.

Evidence: Technical Assistance Document for Anthrax response for the National Response Team. National Food Security System Strategy document with FDA (President's Council on Food Safety). Pesticide Data Program at USDA.

Does the program use strong financial management practices?

Explanation: The program follows EPA's guidelines for committing, obligating, reprogramming, and reconciling appropriated funds. Agency officials have a system of controls and accountability, based on GAO and other principles, to ensure that improper payments are not made. At each step, the propriety of the payment is reviewed. EPA trains individuals to ensure that they understand their roles and responsibilities for invoice review. EPA received an unqualified audit opinion on its FY02 financial statements and had no material weaknesses associated with the audit. EPA is working to meet the new accelerated due dates for financial statements. Agency level contracts & grants office conducts audits to ensure proper procedures are followed. Office of Pesticide Programs (OPP) maintains central database to track grant and contract funding status and systems are tracking FTE and contract expenditures. OPP participated in pilot of Agency financial tracking/reporting system.

Evidence: FY 2001 Agency Annual Financial Statement. IG audits that report on material weaknesses. IG annual fee audit.

Has the program taken meaningful steps to address its management deficiencies?

Explanation: OPP has made progress in addressing management deficiencies, most notably through the implementation of improved IT systems. OPP does have a clear annual work plan development process focused on meeting annual goals (which do not currently include any sort of productivity/cost effectiveness/efficiency targets but will in the near future). In FY 2003, the program implemented programmatic efficiency measures and begun tracking results, but has no data yet to evaluate their usefulness. Though monthly and semi-annual review meetings are conducted at multiple levels and many management issues are identified and addressed through this process, there is no evidence of a defined system within the program that tracking the identification and correction of management deficiencies.

Evidence: New efficiency goals. Office of Pesticides Programs Information Network (OPPIN). Management review meeting results.

Has the program demonstrated adequate progress in achieving its long-term outcome performance goals?

Explanation: The current long-term outcome indicator goals were established in FY 2002 and tracking began in FY 2003 so it is not possible to make an assessment of historical progress at this point. Reviews of initial data indicate that positive progress is being made. In addition, the program has agreed to develop risk-based long term outcome goals that will better and more directly reflect the specific program activities.

Evidence: EPA FY 2003 Annual Report.

Does the program (including program partners) achieve its annual performance goals?

Explanation: The program received a Yes for Question 2.3 and a No for question 2.4 so according to the PART guidance, the program can receive no higher than a Small Extent rating for this question. Annual output goals are essential for measuring performance of program. Program has met existing annual performance goals evaluated in Section 2, Q2 for FY99, FY00 and partially in FY01. Given the existence of backlogs and feedback from customers, work needs to be done to evaluate the appropriateness and level of challenge associated with existing annual goals. New/revised annual goals may be needed to support the risk-based long term goals under development.

Evidence: Additional data on 1988-2001 accomplishments was provided by the agency. No concrete comparison can be made for years prior to 1999 because targets were not established and/or published prior to the implementation of their GPRA goal-based budget. Estimating targets for the existing annual performance goals for the Registration Program is complicated by the variability in what registration petitions are submitted.

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program performance goals each year?

Explanation: Historically the program has not used efficiency measures. In FY 2003, the program did develop output efficiency measures for certain aspects of the program. Data from these measures will be helpful for future assessments. Backlogs still exist for several types of registration actions and it is not clear that significant progress has been made year to year in reducing their size. The program has taken other steps to improve the efficiency of certain processes (see evidence).

Evidence: Most of the program's primary data review activities are done by contractors (more than 22 FTE for the registration program), resulting in a savings of FTE for work on higher level science review, analysis and risk assessment, more effectively and efficiently utilizing resources. Implemented an electronic labeling program under which registrants can submit labels electronically (via PDF file) and reviewers in the registration program, using Adobe Acrobat, can very quickly identify changes from the previously approved label(s). Established a formal process by which registrants can submit studies (including sensitive data) supporting registrations electronically. Electronic submissions help to expedite review of studies. Implementing internal procedural changes for section 18 activities to shorten the time it takes to grant an emergency exemption.

Does the performance of this program compare favorably to other programs, including government, private, etc., that have similar purpose and goals?

Explanation: There are no other programs that have a similar enough purpose and have the same or substantially similar goal structure to compare performance against. There are other programs that perform similar activities (though for different purposes). It could be beneficial to evaluate the operation of those programs to see if any of the successful aspects can be replicated in the Registration Program or more broadly in the Office of Pesticide Programs.

Evidence:  

Do independent and quality evaluations of this program indicate that the program is effective and achieving results?

Explanation: Program needs to have independent evaluation(s). Certain stakeholders have indicated concern about the level of efficiency of the program but have also expressed support the program's purpose.

Evidence: During the FY04 PART process, OMB informally collected feedback from some stakeholders (i.e. pesticide manufactures and other federal agencies) on Registration program performance and design.