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Current as of December 2012
To help ensure that the agency has the best available data and information for making pesticide registration review decisions, EPA has begun holding Focus Meetings.
On This Page:
- Scope and Purpose of Focus Meetings
- Initiation and Timing of Focus Meetings
- Focus Meeting Topics
- Benefits of Focus Meetings to the Agency
- Incentives for Registrants to Participate
- Next Steps After the Focus Meeting
A Focus Meeting is a meeting or teleconference typically initiated by the EPA with affected registrants and possibly other stakeholders that focuses on the information needs identified by the EPA chemical review team and management for consideration during the agency’s registration review of a pesticide.
Focus Meetings provide an opportunity to address areas of uncertainty that may affect our risk assessment and risk management decisions for a pesticide. The desired outcome for the agency is to acquire the information necessary to conduct high quality risk assessments that reflect the labeled use of the pesticide the first time.
While Focus Meetings are not required, we strongly encourage their use. They should definitely be scheduled if and when the EPA chemical review team identifies important knowledge gaps that will affect our understanding of risks.
Typically, the EPA schedules a Focus Meeting early in the registration review process, between the agency’s first chemical review team meeting and development of the problem formulation and scoping documents. However, a chemical review team may learn of areas for which additional information or clarification is needed later in the registration review process. The EPA can initiate discussions with the registrants or other parties at any point in the process.
We typically initiate a Focus Meeting by sending an invitation letter that highlights specific areas that we have identified to help minimize important uncertainties regarding the pesticide. The meeting can be held in person or as a conference call. The meeting venue depends on the complexity of the issues and the schedules of key participants.
For some cases, the number and timing of the meetings could vary. For example, if a pesticide has both agricultural and consumer uses, separate Focus Meetings may be appropriate because the issues and registrants may be different.
Depending on the potential risk, complexity and uncertainty involved in a chemical case, no formal Focus Meeting may be needed. For example, if there are recent risk assessments, clear labels and no major risk concerns, a Focus Meeting may not be necessary.
A registrant also may request a Focus Meeting. EPA’s long standing policy is to grant any reasonable meeting request, such as a request for a Focus Meeting, providing that an appropriate topic and agenda are available. Regardless of who initiates the Focus Meeting, the purpose of the meeting remains the same.
In a Focus Meeting, EPA describes key areas of uncertainty and the likely consequences of that uncertainty. For example, unclear labels or missing data will result in the agency needing to use conservative assumptions in the risk assessment. Although the meetings typically involve labeling or data issues, the focus can be on any area that the chemical review team identifies as an important source of uncertainty.
Common topics and objectives for Focus Meetings include:Gain Clarity on Labels and Use Patterns
Provide registrant(s) with an opportunity to:
- clean up labels (clarify use patterns, remove ambiguities, etc.) before risk assessment
- identify supported products, uses and use patterns
- review and comment on EPA’s Label Use Information System Report
- clarify usage and address label uncertainty (which may reduce either data needs or the use of conservative assumptions in the risk assessment)
Registrants are encouraged to develop a master label or other alternative approaches that reflect all supported uses and use patterns.
Gain Clarity on Upcoming Actions
Registrants identify any planned registration applications, tolerance petitions or other pertinent information that may affect the substance and timing of the risk assessment.
Identify Data Already Generated by or Requested from Registrants
Registrants identify and discuss existing data not submitted to EPA. These data may reduce data needs and uncertainties. For example, a study conducted for registration in another country may help reduce uncertainty or fill a data need.
Identify Use Patterns Likely to Result in an Endangered Species Act “May Effect” Determination
Generally, this information can be based on the most recent ecological risk assessments.
With better information, the EPA can narrow the scope of a pesticide re-evaluation to areas that are the “real” risk concerns, i.e., concerns based on intended and labeled use patterns. The narrowing of scope will help save resources in developing problem formulations, scoping documents, and work plans, and in minimizing rework at the risk assessment stage of the process.
For example, having a good understanding of a use pattern could reduce or eliminate our need for certain data or preclude the use of overly conservative assumptions that will lead to rework later in the process. We anticipate that in many circumstances, the registrant will be required to submit revised labels before we can eliminate identified data needs or conservative assumptions. By obtaining data that the registrant has already generated, we may no longer have to request the data in the problem formulation and scoping documents.
Registrants benefit from Focus Meetings through increased efficiency of the risk assessment process. When the EPA has all the available information:
- the EPA will have fewer data requirements and
- the initial risk assessment will not need to include overly conservative assumptions.
Again, registrants will likely be required in many circumstances to submit label amendments before we can eliminate identified data needs or conservative assumptions.
There are many circumstances in which a Focus Meeting may be valuable to the registrant as well as the EPA. If the directions for use on a pesticide product label are vague and the agency’s very conservative assumptions will lead to extensive data requirements, a Focus Meeting would be a good opportunity for the registrant to explain how the product is used. The EPA chemical review team and the registrant could then work together to modify the directions for use before preparation of the risk assessment.
Even in circumstances where labels are clear and the risk assessments are current with minimal uncertainty, a Focus Meeting may be warranted. For example, if the agency’s previous decision required the balancing of risks and benefits, a meeting focusing on potential changes in benefits could present an opportunity to obtain updated benefit information and/or early mitigation.
Focus Meetings also provide an opportunity for registrants to identify likely ESA issues. As a result, consultation packages sent to the U.S. Fish and Wildlife Service and National Marine Fisheries Service could be more limited in scope and could contain fewer federally listed species on which to consult.
Should a registrant decide to submit data, we encourage them to do so electronically. Read more about electronic submissions.
The EPA places Focus Meeting minutes and related material (the invitation letter, documents provided by the agency or registrants, and any other related material) in the docket shortly after the meeting. Under the registration review rule (40 CFR 155.52), the EPA has 45 days to docket meeting minutes and related materials. However, the agency’s goal is to docket Focus Meeting material within 10 business days.
A special Focus Meetings docket has been established for meeting material; visit EPA-HQ-OPP-2012-0778 at www.regulations.gov. To provide easy access to this information, the Focus Meeting files will also be included in the chemical-specific registration review dockets when opened.
After the Focus Meeting, the EPA reviews the list of existing studies identified by the registrant(s) to determine which studies may inform problem formulation and scoping documents. The EPA will follow up with USDA or commodity groups on proposed use site/label changes, if applicable. Additional follow-up meetings and calls will be conducted as needed.