EPA, OFFICE OF PESTICIDE PROGRAMS ERROR CORRECTION PILOT & NEW ACTIVE INGREDIENT IMPROVEMENT PROJECTS

Transcription

1 EPA, OFFICE OF PESTICIDE PROGRAMS ERROR CORRECTION PILOT & NEW ACTIVE INGREDIENT IMPROVEMENT PROJECTS Derek Edmund Scott EPA, Office of Pesticides Programs

2 2 Increased Transparency for Applicants on PRIA Actions Requiring Public Participation Applicants are proposing OPP provide them an opportunity to conduct error reviews of all draft/preliminary risk assessments prior to public participation. Generally, applicants are already provided early access to drafts when there are potential risk issues at stake or there is missing data, but are only being provided the problematic portion(s) of the risk assessment. As a result, applicants have indicated they either have to accept assessments containing errors to get the registration as quickly as possible, or provide comments identifying the errors during the public participation process which they feel would likely delay the registration in order to address these concerns.

3 3 Error Correction Pilot In response to this issue, OPP launched a pilot error correction process with four chemicals: two conventional chemicals, one antimicrobial, and one bio-pesticide. Under this pilot, errors are defined as, Issues including and restricted to: 1) calculation errors; 2) transcription, typographical, or grammatical errors; or 3) incorrect citations or references. As such, applicant questions about or challenges to policy implementation, model inputs, and science interpretation fall outside the scope of this error definition and were not addressed in the pilot. Participants were given a description of the intent and parameters of the pilot, full copies of draft risk assessments (DRA), and were given two-weeks to review the DRAs and flag errors.

4 4 Evaluation Criteria Pilot outcomes are being evaluated upon Whether comments were received within two weeks The number and type of notations, (i.e., did annotations/comments fall within the pilot error definition) The significance of the errors cited relative to final determination Additional time needed to correct errors

5 5 Conventional Chemical 1 Applicant responded within the two week window. Reported no obvious errors or needed modifications. Provided additional comments about assessment conclusions that were outside the pilot scope, (i.e., a recommendation to lower a crop tolerance).

6 6 Conventional Chemical 2 Applicant responded within the two week window and flagged five issues on the ecological risk assessment. Two issues were outside the pilot scope. Three issues are possible errors and are currently being followed up on with the science division. Confirm whether the issues fall within or outside the project scope. Significance of the errors. Added time needed to complete the error correction(s). The human health DRA was just recently sent to the participant and we are still within the two week review timeframe. Outcomes to follow.

7 7 Antimicrobial and Bio-Pesticide Chemicals Antimicrobial Applicant did not respond to the error correction request within the two week window. During a subsequent follow-up conversation, the participant stated verbally they had reviewed the document, found no errors, and offered no additional comments. Bio-pesticide - Applicant responded within the two week window and reported no errors nor needed modifications.

8 8 New Active Ingredient (AI) Project OPP Registration Division (RD) is currently evaluating the new ai process to Determine causative factors impacting PRIA completion rates Identify and implement solutions to improve ontime performance, process efficiency, stakeholder collaboration, and transparency.

9 9 Key Issues Impacting New AI Process 1. Meeting the timeline is challenging in relation to increased level of effort and refinements needed for new ais. 2. There are a wider and greater complexity of issues being raised during public comments. 3. Key timeline factors in the new ai process Refining and fully characterizing risks Harmonizing maximum residue levels Resolution of regulatory and labeling issues

10 10 New AI Improvements Have Been Being Implemented 1. OPP/RD conducting tighter 21-day completion and 90-day technical screens to reduce acceptance of incomplete/deficient packages that cause delays and rework. Application packages must be complete or should include acceptable waiver(s) or bridging argument

11 11 New AI Improvements 2. Using pre-submission meetings to ask applicants to voluntarily provide benefits information with their applications 3. RD and the science divisions are conducting crossdivisional 90-day technical screen meetings to strengthen technical evaluations/decisions. 4. Mid-process check-in meetings for all new AIs to ensure deliverables are on track and to flag risks of concern and data quality issues earlier in the process 5. Cross-divisional briefings where divisions synopsizes DRAs, risk characterizations, conclusions and decision recommendations. 6. Increased management oversight

12 12 Expected Benefits Improved package completeness and data quality will reduce process delays and rework. More timely identification and management of issues impacting decision timeline, (e.g., risks of concern, delayed deliverables) Better integration of risk assessment and risk management processes Improved collaboration, efficiency and transparency Reduction in due date renegotiations

13 13 Joint Review Retrospective During the 2015 NAFTA meeting, EPA and industry agreed to conduct concurrent retrospective analyses of the joint review process to identify potential improvements OPP is currently is the process of distilling lessons learned to a set of procedural, process, and policy improvements proposals that will be shared with industry and PMRA. PMRA is also conducting its own parallel joint review retrospective. November 2016 NAFTA Meeting EPA and PMRA agree to joint review improvements

14 14 Additional Improvement Objectives Going forward, continue to analyze and evaluate the new ai process to Streamline the process and identify and implement efficiencies Effectively incorporate new steps and requirements into the process. Improve communication, collaboration, and transparency in managing risks of concern GOAL: Reliable Decision Timeline

15 15 Questions?