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PRIA Process Improvement Workgroup
The PPDC PRIA Process Improvement Workgroup met on September 23, 2008, its eleventh meeting since the Pesticide Registration Improvement Act (PRIA) of 2003 was enacted. Minutes of this meeting will be posted in November on the Web site.
Background
- A PRIA provision directs the Agency to identify and evaluate reforms to the pesticide registration process under PRIA with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Act of 2003 for covered pesticide registration applications (including reduced risk applications) to the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks.
- When PRIA was reauthorized October 1, 2007 with PRIA 2 (Pesticide Registration Improvement Renewal Act), the Agency’s reporting requirements were expanded to include process improvements in registration review.
- The PPDC PRIA Process Improvement Workgroup provides a forum in which stakeholders and the Agency discuss improvements in both the pesticide registration and registration review processes.
- The Agency updates stakeholders on organizational changes, guidance, tool and model development, information management, process modifications, etc to improve application quality and the efficiency, consistency, and quality of the decision making process.
- Stakeholders offer their suggestions on what would help them develop better applications and their observations on inconsistencies and needs for guidance, information and application tools.
September, 2008 meeting
The focus of the September, 2008 meeting was information management.
- Since July 2008, the Agency has been accepting electronic copies of a pesticide application and its experience with these submissions was discussed.
- Between July 15 and September 23, 2008, received 95 application packages via e-Submission
- 14% of all submissions were e-submission.
- Advice was provided on avoiding common errors.
- To increase the number of electronic submissions, the Agency will issue a Pesticide Program Update and discuss e-submission in various venues.
- 2329 Documents
- 50 packages with issues
- Results of a usability test of an electronic Confidential Statement Formula (CSF) tool that applicants could use to accurately develop this portion of their application were presented. Errors result in additional Agency resource expenditures.
- 23 registrants and pesticide consultants participated in the September 23 usability tests.
- Most participants expressed satisfaction with the tool and encouraged the Agency to make it available.
- Comments and suggestions will be used to improve it.
- Additional usability tests will be conducted on this tool and other application tools currently planned or in development.
- PRIA 2 presented additional challenges for the Agency’s information management systems and improvements in progress will result in less manual record keeping in both the registration and registration review processes.
- The Office of Pesticide Programs Information Network will track the use of electronic label review, due dates for deficiency notices, rejections, fee category changes and send applicant notice of receipt of PRIA start dates.
- Milestones within the registration review process will be tracked to enable the Agency to identify the status of a pesticide at any time.
- Health Effects Division is transitioning from risk assessment branches that conduct assessments for either registration or re-registration to branches conducting both.
- A Toxicology peer review committee (TOXSAC) was formed to review hazard assessments.
- The Antimicrobial Division announced that responsibilities for review of antimicrobial used in the fermentation of fuel ethanol will be posted on the web. The Agency’s mold policy is expected to be issued as a PR Notice this winter or next spring. Stakeholders suggested that alternate label language be developed in place of the phrase “aesthetic purposes”.