Pesticide Program Dialogue Committee PRIA Process Improvement Workgroup October 12, 2004 Meeting Minutes
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Howard Bochnek, Veridien Corp., Reprsenting ISSA
|Others in Attendance
Kristen Brush, FEAD, EPA
- Process Improvements Implemented in the Health Effects Division
- Follow-up from August Workgroup Meeting
- Report from EPA on Recent Trip to Canada's Pest Management Regulatory Agency
- Preparations for Workgroup Report to PPDC
- Next Steps
Overview of Process Improvements in the Health Effects Division
Jess Rowland, Chief of the Science Information Management Branch, Health Effects Division, presented the workgroup with an update on recent process improvements within the Health Effects Division. The first is in the area of dose selection. The Division has formed the “Dose Adequacy Review Team (DART)” to provide guidance on the dose levels selected by registrants in conducting various toxicological studies submitted to the Agency in support of pesticide registration and reregistration. To date, the Team has evaluated 15 chemicals through this process. Greg Watson from Syngenta echoed praise for this new process.
Jess also provided a brief overview of the new risk assessment process in HED. The review process has been streamlined, providing greater empowerment to the risk assessment team. The Hazard Identification Assessment Review Committee (HIARC) and the Metabolism Assessment Review Committee (MARC) have been merged into the Hazard and Exposure Assessment Review Committee (HEXARC). Through this process, chemicals are scoped to identify the level of review needed in the risk assessment. To date, 15 chemicals have been evaluated under this new process.
Follow-up from August Workgroup Meeting
Label Review Inconsistencies
On behalf of the Agency, the Registration Division presented a paper (attached) on identifying and addressing issues regarding consistency in the label review process. In this paper, the Agency suggested that parts of the Label Review Manual which are thought to be incorrect needed to be identified. The Agency agreed to routinely update the Label Review Manual and to provide addendums to the manual. The paper also included a suggestion that a workshop could be organized by industry that would focus on identifying specific examples of labeling areas that need additional guidance/training.
Workgroup members discussed that guidance may be needed for certain types/classes of products (e.g., crack & crevice products, turf products). It was noted that there has been success in these areas in the past, such as the termiticide PR Notice. All agreed that such guidance would be a help to both industry and the Agency. A suggestion was made that these guidance materials could be included as addendums to the Label Review Manual.
Next Step: Industry will identify 3-5 categories per division that could be good candidates for specific guidance
Discussion turned to other types of label review consistencies. While the industry paper raised the issue, the Agency has not received specific examples. Without specific examples, the Agency did not feel that it was in a position to develop a response.
Next Step: Industry will identify some specific examples.
Next Step: Industry will identify those areas of the current Label Review Manual are incorrect.
Broadening Stakeholder Involvement in the Registration Process
Industry has been reviewing the new process proposed by the Agency. Representatives felt that the issues may be different for new chemicals and new uses. There was a general comfort level with releasing the schedules for chemicals decisions, but there was some discomfort with the idea of publishing the individual milestones. There was general agreement that these concerns were significantly reduced post-registration
Next Step: For the next meeting, industry will prepare a response to the Agency's August proposal.Other Issues
Discussion turned to issues associated with the labels posted in the Pesticide Product Label System (PPLS) on the Agency's website. Some states are relying upon this system to tracking EPA-approved labels. There have been occasions when more recent approved labels have not been posted to PPLS and states have not relied on the paper documents submitted by registrants. In addition, when the Agency deviates from PR Notices in approving labeling, some states want to see the Agency's rationale for this before approving the label for use in the state.
Next Step: The workgroup should engage in some discussions with state agencies on these issues.EPA's Recent Trip to Canada's Pest Management Regulatory Agency
The Agency reported on its recent trip. Canada has launched several process improvement initiatives as it has implemented its cost recovery program. Many of these revised processes involved use of information technology to create efficiencies in PMRA’s review process. Canada provided Agency representatives with a detailed overview of these new systems. The Agency plans to work collaboratively with PMRA to see what pieces of these new systems can be transferred/implemented within the US review system.
Preparations for the Workgroup Report to the PPDC
Workgroup members decided that Greg Watson, Howard Bochnek, and Jim Kunstman would present the report on behalf of the entire workgroup. The report will discuss:
- What has been started
- What process improvements are in development,such as labeling
- What process improvements are well underway
- How the FACA process has been very open
The Agency will look to schedule the next workgroup meeting in conjunction with an upcoming SFIREG meeting, possibly in December 2004.
CONSISTENT LABEL REVIEW:
IDENTIFYING AND ADDRESSING ISSUES
Issues surrounding inconsistent label review were ranked by the industry workgroup on PRIA process improvements as one of their highest priorities. A number of examples of inconsistencies were given, some specific suggestions were provided to improve the review process, and various approaches for further addressing this issue were discussed. The Agency was given the task of making a specific proposal to the workgroup on how to address this issue. We have chosen to do this by replying to each specific item discussed in the industry paper or suggested at the first workgroup meeting with our proposal on how to address it.
Suggestions to Identify and Address Issues and the Agency's Proposal in Response
- The industry paper asserts, "Some recommendations in the Label Review Manual (LRM) are inconsistent with provisions of FIFRA, PR notices, or actual agency practice. The LRM should be promptly corrected and maintained as a "living," current electronic guidance document, if it is to be an effective tool for registrants and PM teams."
- The industry paper requests the OPP website should make available copies of all correspondence or other written materials that provide guidance, policy, and interpretive statements pertaining to specific label issues. A suggestion was made at the workgroup meeting to consider the outcomes from the first round of the Consumer Labeling Initiative.
- The industry paper suggests a rejection rate analysis for label approvals would be useful. At the workgroup meeting it was suggested that both rejected and accepted labels be considered.
- The discussion at the workgroup meeting surrounding the collection of additional data focused more on the issue of identifying inconsistencies in label reviews rather than simply identifying reasons for rejection of labels.
The Agency believes that doing a rejection rate type of analysis which looks at identifying the reasons for rejections or collecting data in some other way, for example, taking a sample of labels in the hope of identifying inconsistencies is a very time and resource intensive way of identifying possible inconsistency. Instead, the Agency proposes to address the areas specifically listed in the industry paper--warranty statements, arrangement of the label, etc. and develop additional guidance and update the LRM where necessary.
We are willing to participate in a workshop, to be organized by industry, that would focus on identifying specific examples of areas that need additional guidance/training efforts. The goal of the workshop would be to use the specific examples to identify the important, recurring themes on which the Agency should focus. The Agency will then address these areas through providing further guidance and updating the LRM and by providing additional training, as necessary. We believe that the best way to identify and address additional areas of possible inconsistency, as they arise, is for industry and others to report inconsistencies to the Division Ombudsmen. The Agency will address reported inconsistencies by rectifying the situation identified, if necessary, and providing additional guidance where appropriate to help ensure that the same issue does not keep reappearing.
Finally, as was the case in the analysis of rejection rates done previously, the Agency recognizes that some improvement would be possible as the result of more training and increased review of the work of individual risk managers, including vertical review as well as possibly peer review. The Agency will consider ways to continue and increase these activities, especially as many new reviewers are hired as the result of PRIA.
The Agency requests that the parts of the LRM which are thought to be incorrect be specifically identified. The Agency will then consider these comments and update the manual as necessary. Currently the Agency is considering how often addendums will be issued and a proposed schedule for updating the LRM.
The Agency agrees to make available, in the addendums to the LRM, all relevant updates that provide information/guidance relative to specific label issues. These addendums will be made available on the internet. The current edition of the LRM contains a discussion of the initial outcomes of the Consumer Labeling Initiative and label recommendations based on this research.
The Agency has already invested considerable resources in providing guidance to industry and reviewers on label development and review. This includes consideration of the last rejection rate analysis done in the late 1990's and incorporation of this material into the latest edition of the LRM, which was issued in August 2003. (See "Rejection Rate Analysis for Submissions of Product Chemistry Data, Confidential Statement of Formula, and Product Label for Registration and Reregistraion"; and Rejection Rate Analysis Data Package November 12, 1997";). As noted above the LRM also contains an analysis and recommendations based on the Consumer Labeling Initiative. To the extent that additional updates to the LRM need to be made and this process expedited, the Agency believes that the changes noted in 1 and 2 above should facilitate that process and make changes available quickly.