Detailed Information on the
Pesticide Reregistration 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 original PART assessment found that the program was not measuring its level of efficiency. As a result, the program has proposed new output efficiency measures that will promote better management and a more direct focus on efficiently achieving outcomes.

To address the issue of not meeting annual targets and concerns about meeting statutorily-required deadlines, the program did use additional resources for reviewing antimicrobial pesticides and inert ingredients as proposed in the FY 2004 President??s Budget.

The original PART assessment found that the program was not measuring its level of efficiency. As a result, the program has proposed new output efficiency measures that will promote better management and a more direct focus on efficiently achieving outcomes.

Per the Agency targets develop and finalize appropriate regional performance targets.

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

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 refinements of meaningful outcome oriented measures for each of the three mission areas in the new Strategic Plan.

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

Measure: Cumulative percentage of Tolerance Reassessments completed.

Explanation:Measure tracks statutorily-required reviews of pesticide tolerances to ensure that they meet the most current safety standards to adequately protect human health and the environment. Tolerances are maximum pesticide residue limits allowed in or on food. EPA is on track in meeting its 2006 deadline requirement.

Measure: Cumulative percent of Reregistration Eligibility Decisions Completed.

Explanation:Measure tracks progress toward 2008 deadline for completing all reregistration eligibility decisions (REDs). REDs help ensure existing pesticides already in use are safe based on current science. Meeting this deadline may be effected by the FY 2006 appropriations language on human studies. EPA is assessing the extent of this impact.

Measure: Cumulative percentage of tolerance reassessments completed for top 20 foods eaten by children.

Explanation:Measures helps track progress toward statutorily-required deadline to complete all tolerance reassessments by 2006. Measure focuses on high priority pesticides - ones that are used on foods commonly eaten by children.

Measure: Cumulative reduction in the number of systemic poisoning incidents associated with exposure from organophosphate pesticides as reported to Poison Control Centers. (Baseline Under Development)

Explanation:EPA has purchased incident data from the Poison Control Centers which maintains records of all poisoning cases reported. Preliminary analysis shows significant reduction in poisoning associated with organophosphate exposures.

Measure: Reduction in time required to issue Reregistration Eligibility Decisions

Explanation:Measure assesses the reduction in time to issue a re-registration eligibility decision. As a new public participation process, the efficiencies gains and the speed at which gains were realized exceeded the goals set a few years ago. As such, OPP has revised its targets for 2007 and 2008. SRRD will revise the targets to 40% improvement over baseline in 2007 and 60% in 2008. The reason for the 40% is that a third of our planned decisions in 2007 have been in the process for a few years and will pull up the average. These chemicals are part of two significant efforts that involve both cutting edge science and complex risk-management issues.

Measure: Reduction in cost per Reregistration Eligibility Decision.

Explanation:Measure tracks average cost of Reregistration Eligibility Decisions (REDs). Calculation is based on actual Full Time Equivalent (FTE) expended to produce a reregistration decision. The baseline year for this measure will be the actual average cost for FY 01-03.

Is the program purpose clear?

Explanation: The purpose of the Reregistration program is to ensure that all pesticides used in the US, not just newly registered ones, are safe for humans and the environment based on current science standards which include toxicity, exposure, and population considerations. Several statutes authorize the review and reregistration of pesticides and tolerances. The authorities and actions required to accomplish these tasks are outlined clearly in the statutes.

Evidence: Authority to reregister pre-1984 pesticides: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 USC §136a-1. Authority to reassess pesticide tolerances: Federal Food, Drug, and Cosmetic Act (FFDCA), 21 USC §346a (b)(2)(B)(v). The Food Quality Protection Act (FQPA), P.L. 104-170 (which amended FIFRA and FFDCA).

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 and therefore controls are needed to ensure safety and proper use. Over time, more is learned about the effects chemicals have on human health and ecosystems and thus it is necessary to review registered pesticides periodically to determine if additional or lesser controls are needed. Statute authorizes specific review programs for tolerance reassessment and the reregistration of pesticides registered before 1984. Statute also requires the implementation of a long term registration review program with a 15 year review cycle.

Evidence: Requirement to reregister pre-1984 pesticdes has not been completed yet-Authority: FIFRA, 7 USC §136a-1. Once complete, requirement to review all registered pesticides every 15 years kicks in (Registration Review program)-Authority: FIFRA. 7 USC §136a(g). Ongoing requirement to review tolerances: FFDCA, 21 USC §346a (b)(2)(B)(v)

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

Explanation: The program is the sole national-level pesticide reregistration program and thus the only national-level program addressing the identified purpose and need. It is essential that reregistration occurs at the national level to ensure equal and consistent human health protection across all states. California does have a similar but smaller-scale, state-specific program for reviewing pesticides. The Reregistration program works with California to harmonize schedules and share data when possible.

Evidence: FIFRA, 7 USC §136a-1(a); FFDCA 21 USC §346a (b)(2)(B)(v) gives authority to Administrator. State authority: FIFRA, 7 USC §136v, FFDCA §346a (4)(n).

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

Explanation: There is no evidence to indicate that a different program design would be more effective or efficient than what is currently used. Because of the high costs (public and private) associated with reregistering a pesticide and the need to ensure national consistency, delegation to individual states is not a viable option. The 1996 FQPA changes added clarity to the science reviews and introduced higher visibility deadlines, which forced increased effectiveness.

Evidence: Specificity in statutory mandates establishing program indicates Congressional support for this approach. External National Advisory Committee (called CARAT) in place to help guide reregistration and tolerance reassessment.

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

Explanation: To help ensure the program is effectively targeted, statutes establish criteria for prioritizing reregistration activities and sets specific deadlines and timelines for completion. The agency created a category system for tolerances to ensure that the highest risk pesticides received appropriate attention. Proper prioritization supports maximizing benefits to the general public. Reregistrations, like registrations, are generally registrant-specific licenses to legally produce and sell particular products for predetermined uses. The registrants receive direct benefits from the reregistration. In addition, the program leverages private funding by design - statute requires registrants to supply the data (i.e fund testing) necessary to complete a reregistration and to pay fees to EPA for the reregistration activities the agency must undertake.

Evidence: Prioritization of reregistration: FIFRA, 7 USC 136a-1(c)(1). Registration (Maintenance) fees: FIFRA, 7 USC 136a-1(i). Registrant data responsibility: FIFRA, 7 USC 136a-1(d)(3).

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 contributes to Office of Pesticide Programs long-term goals and has proposed additional outcome goals. The program is committed to continual improvement of its outcome measures and is currently evaluating data that may augment or replace existing measures within the next 12 months. For example, efforts are underway to estimate dietary risks avoided which has the potential to refine or replace our current measure of reduced residues in foods commonly consumed by children. In addition, the program is evaluating the viability of using data on concentration levels in humans as a measure for general population risk reduction.

Evidence: EPA Annual Performance Reports and Plans, Congressional justifications (2002-2004). Memo from Deputy Director of the Office of Pesticide Programs regarding office commitment to develop better outcome measures.

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

Explanation: The program has made strides in the development and implementation of long-term outcome goals. The three measures proposed are good. One has targets but the baseline is still under development. One has a baseline but no outyear targets. The third has both a baseline and targets and is currently in use.

Evidence:  

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

Explanation: The Reregistration program has several annual measures that directly reflect program performance and are useful for program and resource management. The annual goals are output measures but are acceptable because it is a process-oriented licensing program that results in "products" (reregistrations). By completing reregistration actions, the program is directly addressing the purpose and needs identified in Section I and contributes to the achievement of the long-term outcome goals. The program has also proposed two useful programmatic output efficiency measures that encourage increased productivity - reduction in the cost per reregistration decision and the reduction in elapsed time between the initiation of the public participation process and the reregistration decision. In addition, the Office of Pesticides Programs has undertaken a broad effort to identify and develop better outcome goals and indicator data.

Evidence: EPA Annual Performance Reports and Plans, Congressional justifications (2002-2004). Required reporting of statutorily-defined annual output goals: FIFRA, 7 USC §136a-1(l) - Federal Register, Vol 69, No. 87 May 5, 2004 "Pesticide Reregistration Performance Measures and Goals", p 25084.

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

Explanation: The program has statutorily-required completion dates for certain actions. The annual output goals reflect the activity required to meet those dates. The program did have difficulty meeting annual targets in the past, leading to changes in the statutorily-required dates. The targets and baselines for the output measures are adequate and the program has developed two programmatic efficiency measures, justifying a yes answer for this question. The program has proposed some annual targets for the long-term outcome measures evaluated under Section 2, Question 1 but the baselines for those are under development. In addition, a new program is under development which will replace the Reregistration program in the 2008 timeframe and measures may need to change to accomodate this new program.

Evidence: FIFRA, 7 USC §136a-1(g)(2)(A)(ii): complete all reregistration assessments by 2008. FFDCA, 21 USC §346a(q)(1)(C): complete all tolerance reassessments by 2006. These dates have changed over time because of backlog issues at the agency, consent decree agreements, and changing statutory requirements, particularly the enactment of the Food Quality Protection Act (FQPA) in 1996.

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) 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 for every contract and grant that support this program. These measures are tied directly to annual performance goals of the program. Work Assignments have specific deliverables, costs, and schedules. Monthly Surveillance Reports are submitted to the EPA and are reviewed by the Work Assignment Manager who documents whether the performance is satisfactory.

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

Are independent 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: A Yes answer to this question would require regularly scheduled, objective, high quality independent evaluations that examine how well the program is accomplishing its mission and meeting its long term goals. While some of the evaluations presented by EPA meet some of the criteria, none meet all of the criteria in the PART guidance.

Evidence:  

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 its budget structure aligned with its GPRA goals for some time. For the reregistration program, funding changes can be translated into changes in review time or the number of reregistration reviews completed. The Office of Pesticide Programs tracks division budgets and can present funding easily at the program level. In addition, the program developed a marginal cost analysis on the reregistration program which looks at the impact of resource allocations (dollars and FTEs) on completing the required reassessments.

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 spreasheet ("Rainbow" table) that breaks the OPP budget down further by linking all programs and activities to the existing GPRA goal structure. Funding for the Reregistration program is one of programs in 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 Reregistration program contributes to the agency-wide strategic plan revision process. The Office of PRevention, Pesticides, and Toxic Substances (OPPTS) -which includes the Reregistration program- does have and internal strategic planning process that involves a management retreat. The Office of Pesticides Programs has initiated an indicators project to develop better outcome goals that cover all the pesticides programs as well as to evaluate and promote the collection of better data to measure progress. In addition, the Reregistration program is using long-term planning as it assists in the development of its successor program, the Registration Review program. Though no central tracking system (such as a database or spreadsheet) exists currently for storing planning decisions, the OPPTS budget office is currently developing one.

Evidence: Registration Review program authority: FIFRA, 7 USC §136a(g). Indicators project includes review of data sources to support better outcome goals including UDSA's Pesticide Data Program and the Poison Control Center. The program also has a project underway that is examining the correlation between reported adverse effects as required under FIFRA §136d(a)(2) with the implementation of reregistration regulatory decisions. Priorities Matrix developed for each program through annual planning meetings - matrix includes long- and short-term planning issues.

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 multiple electronic methods to track information on the progress of reregistration actions and reports on the progress of activities are provided to program management weekly. A tracking report (Outputs Report) is produced regularly which includes all major reregistration milestones for all remaining chemicals subject to reregistration. These reports are a major planning tool for all divisions and branches contributing to the reregistration process. Senior management in the Office of Pesticide Programs meets monthly to discuss progress and make changes necessary to keep on schedule and resource reallocation (in terms of personnel effort) is done real-time to achieve highest priorities.

Evidence: Office of Pesticides Programs Information Network (OPPIN) is a central database used to track activity - stores history - easily retrievable. Reregistration Outputs Report provides summary of status, milestones, and deadlines. No database exists to track activity while the reregistrations are under review in the science divisions.

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation: All SES managers have the program's 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 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 Office of Pesticide Programs (OPP) develops an Operating Plan based on the agency's Annual Performance Plan. OPP tracks contract and grant requests for obligation of resources to the resource allocation plan to ensure that the request has been approved or that changes have been documented and approved. Resources are allocated by goal, objective and program code specific to each program. The Assistant Administrator responsible for the Reregistration reviews obligations monthly. Obligations and expenditures are also tracked in the Agency's Integrated Financial Management System (IFMS) against the Operating Plan.

Evidence: Agency accounting systems and Financial management directives. Annual Performance Plan and Congressional Justification. OPP contracts and grants database, resource allocation plan, and status reports. In FY 2002 93.3% of the EPM and 94% of S&T was obligated by the end of the fiscal year for re-registration.

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

Explanation: The program has proposed two efficiency measures, one dealing with reducing the time to complete reregistration decisions and a second on reducing reregistration costs. OPP was one of the first offices in the Agency to participate in a competitive sourcing/cost comparison exercise under OMB's streamlined competitive sourcing guidelines. The Reregistration program participated in the development of and contributes to the Office of Pesticide Progams Information Network (OPPIN), which combines several independent databases to allow the risk manager to assemble information for review and/or development of regulatory documents more efficiently.

Evidence: Capital Planning and Investment Control submission for OPPIN. Analysis for FAIR act competitive sourcing.

Does the program collaborate and coordinate effectively with related programs?

Explanation: The program does collaborates with related programs and stakeholders as needed to complete its statuory obligations. For example, the program works with California in planning reviews, sharing data, and where appropriate, sharing work. The program also works with USDA's Office of Pest Management Practices (OPMS) when developing risk assessments and risk mitigation decisions because OPMS provides critical information on grower community needs and agricultural production practices. Task forces have also been established to share information, develop data, and share costs.

Evidence: Current effort to review fumigant pesticides with the state of California. Potentially impacted stakeholders are included in reregistration eligibility discussions and provide comment on reregistration eligibility decisions. EPA organized industry-wide task forces (such as Agricultural Reentry Tasl Force): FIFRA, §136a(c)(2)(B)(ii).

Does the program use strong financial management practices?

Explanation: The program follows EPA's financial management guidelines for committing, obligating, reprogramming, and reconciling appropriated funds. EPA received an unqualified audit opinion on its FY02 financial statements and had no material weaknesses associated with the audit. Agency level contracts & grants office conducts audits to ensure proper procedures are followed. EPA's OIG annually audits the reregistration program to ensure that financial statements are fairly presented and conform to generally accepted accounting principles, that internal controls for financial reporting are in place, and that the program is in compliance with regulations.

Evidence: OIG Audit Reports for the Reregistration program and for pesticide fees. Agency financial statements. Internal "Rainbow" spreadsheet that tracks funding and is used for managing certain financial information. Agency-wide clean audit opinions and no identified material weaknesses.

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

Explanation: Insufficient evidence of a process for or examples of how the program identifies and corrects management deficiencies was provided.

Evidence:  

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

Explanation: According to the guidance, if the program received a Yes for question 2.1 and a No for question 2.2, the highest possible score for this question is a Small Extent. This program contributes to some long-term measures that are used across the Office of Pesticide Programs and progress has been adequate on those measures.

Evidence: New measures have been proposed and targets are under development. Given the recent progress on the Reregistration annual measures, the program has adequately contributed to the established OPP long-term measures.

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

Explanation: Currently the program is largely on track to achieve many of its annual output goals but this has not historically been the case. The program had difficulty achieving annual targets to such a degree that the statutorily-set completion year for the program had to be extented. The enactment of FQPA in 1996 also caused a slow down in progress becasue the new statute included substantial new risk assessment requirements which required the program to develop new policies and procedures to implement. In the recent past progress has steadied but the program may have trouble again in the 2006 timeframe because of the difficult pesticide reregistrations remaining.

Evidence: The program is required by statute (FIFRA §136a-1(l)) to publish in the Federal Register its progress on annual output goals: FR Vol 69, No. 87, May 5, 2004 "Pesticide Reregistration Perfomance Measures and Goals". Reregistration Outputs Report (report on reregistration status and milestones used by management). Agency and Office of Pesticides Annual Reports.

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

Explanation: The program has developed two efficiency measures but has not yet collected enough data to establish efficiency trends. Other actions have been taken to improve efficiencies such as

Evidence: EPA 2003 Strategic Plan shows refined performance measures. Efficiency measures proposed and data is already being collected to support them.

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

Explanation: There are no other programs that have a similar enough purpose and scope and have the same or substantially similar goal structure to compare performance against. There is only one state-level program that performs some of same activities from a state-specific perspective and it comparison in this context would not yield useful results.

Evidence:  

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

Explanation: As mentioned in the response to Question 2.6, some evaluations have been performed, but none satisfy all four criteria of regularity, independence, quality, and scope.

Evidence: