Guidance for Pre-Application Meetings on New Active Ingredients, Major New Uses and Other Registration Actions

The Antimicrobials Division (AD) of the Office of Pesticide Programs (OPP) is providing guidance to its staff concerning meetings with companies that are considering submitting an application involving a:

• new active ingredient;
• new use;
• new technology; or
• any innovation that requires significant data to be generated and submitted.

This guidance also can be applied to any other meetings that registrants or applicants may request concerning their applications or products.

By following this guidance, AD staff should be able to set up, run and record meetings that are as productive and efficient as possible, and that will assist applicants in submitting applications that contain all of the information required to make a decision on whether to register the product.

Pre-application meetings should cover only topics related to the preparation of an application that will be complete and ready to enter EPA review. Such topics could include, for example, appropriate categorization of use pattern based on proposed labeling, data requirements, and testing methodologies. Pre-application meetings should not be used to obtain EPA decisions on the content of the application package, for example, the acceptability of test data. Finally, AD staff should discourage prospective applicants from using pre-application meetings to make marketing presentations or to raise other matters that are outside EPA's regulatory purview. Post-application meetings should focus on issues of completeness of the application or what further steps need to be taken by the applicant or the Agency before a registration decision may be made.

• Necessity for meeting
• Initial request
• Agency response to initial requests
• Additional material
• Timing of AD company meeting
• Conduct of the meeting
• Summary of meeting
• Sample letter format for a registration meeting summary

Necessity for Meeting

The first question for AD and potential applicants should be "Is a meeting necessary?" Both EPA and potential applicants have limited resources, and it is important that everyone's time be used as efficiently and productively as possible. Therefore, AD staff should not hold meetings to address matters that are already adequately addressed in existing Agency guidance, or by correspondence or telephone conversations with Agency staff.

To the extent possible, AD staff should encourage potential applicants to raise issues in writing in advance of a meeting, and, where appropriate, AD will respond in writing, thus eliminating the need for a meeting. AD staff should anticipate that there may be several exchanges of information before EPA and the company have determined whether it would be beneficial to schedule a meeting.

Initial Request

AD staff should encourage a company interested in a pre-application meeting on the following topics to submit an email request to OPP_AD_Ombudsman@epa.gov:

• New active ingredients
• Significant new uses of old chemicals
• New technologies (such as treated articles with public health claims)
• New or revised efficacy protocols (such as for new pests and new methods of application)
• Data waiver requests related to unregistered products or uses (involving reasons such as low risk, naturally occurring substances, historical use, GRAS, etc.)

The request would ideally include the following information:

• Identity of any new active ingredient: chemical name, chemical formula, structural formula, and chemical class. [EPA will use this information to make a decision about which regulatory branch will handle any application.]
• Description of the proposed use(s) and product claims (labeling): whether the product will make public health claims, whether a "food use" is involved, and the method of application.
• Issues: what the company wishes to raise for AD consideration.
• Summary of any previous discussions involving EPA staff on the issues.
• Tentative dates for meeting desired by the requestor.

Agency Response to Initial Requests

AD staff should respond to initial requests for meetings within two to four weeks of receipt of the request with the following:

Branch and Product Manager assignments for new active ingredients: If AD agrees that a meeting is needed, AD staff will contact the requestor to determine a feasible date/time for a meeting and to ask for the additional material described below. If AD believes that the issues posed may be more efficiently handled through correspondence or a telephone discussion, AD staff will confer with the requestor and then respond accordingly. In any case, the decision as to whether a meeting is needed will be made by mutual agreement

Additional Material

If AD decides to hold a meeting with a company, AD staff should encourage the company to supply additional information needed to make the meeting productive and efficient. The materials should include:

• List of Data Requirements: List the applicable data requirements derived from EPA's data requirements rule at 40 CFR 158, Subpart W (when proposed), and identify any specific requirements for which the company would anticipate seeking a waiver, together with a brief explanation of the basis for the waiver request.
• Compliance with the FFDCA: State whether any clearances under the FFDCA are needed for the pesticide product (section 408 and/or 409), and, if so, whether such clearances have been obtained or are being sought.
• Draft labeling: Provide a label for the product or equivalent document setting out product use directions and associated claims.
• Non-pesticidal uses: Describe any non-pesticidal uses of the new active ingredient.
• Agenda and likely attendees for the meeting: List the topics to be covered and the people from the company who will be attending [the latter information is essential to ensure that an adequate sized room is available].
• Company handouts: Provide a copy of any materials that will be used by the company in its presentation at the meeting at least two weeks before the meeting .

Timing of AD-Company Meeting

AD staff should encourage the company to identify several possible dates and times for the meeting. Generally, given the busy schedules of AD managers and senior scientists, the proposed meeting dates should be at least four weeks after the date of the letter containing the proposed meeting dates. Moreover, the proposed meeting dates should be at least two weeks after the date on which the company plans to submit the "Advance Materials" specified in the paragraph above.

Conduct of the Meeting

The meeting length should be adequate to allow for presentations by the company and discussion between the company and Agency staff. Generally, the meetings should generally be from one to no more than two hours in length. AD staff should encourage the company d to clearly identify any material handed out or discussed at the meeting that it considers to be trade secret or CBI. AD will designate a staff person to take notes during the meeting and record who attended.

Summary of Meeting

Within 30 days after the meeting, AD intends to provide a set of minutes describing the matters discussed, any commitments made by any party, and any conclusions reached at the meeting (see attached sample format for a letter summarizing the meeting). In some cases, AD staff may prepare a summary document and agree upon it at the close of the meeting. While AD intends to honor the written commitments it makes through the process of pre_application meetings, it reserves the discretion to change its decision with respect to a written commitment in the event that either statutory or regulatory provisions would require a different outcome. In addition, AD may change its position if new facts, additional information, or analysis raise concerns about potential risk or unreasonable adverse effects on the environment. AD staff should endeavor to communicate any changes to the applicant as they occur.

Sample Letter Format for a Registration Meeting Summary

[Insert name & address person representing the registrant]

Subject:          Meeting of [insert date]
                      Brand X New Disinfectant Product
                      [Insert EPA File Symbol or EPA Reg. No., if available]

Dear Ms./Mr. (insert company representative):

On [insert date], the Agency met with your company [insert name of the primary company and any other companies or entities present] to [state purpose of meeting, such as "discuss draft efficacy protocols that you submitted for use of your product as a fruit and vegetable rinse"].

Attending the meeting were [insert names, titles, and affiliations of all those present].

Following is a summary of the key points addressed in the meeting along with EPA's guidance, conclusions or commitments for further action:

1. [Insert the major points discussed and the outcome of each.]

If you believe that this summary is not complete, please let me know. Should you have any questions about this letter, you may contact (inert EPA staff name] at [insert telephone number and e-mail address].

Sincerely,

[insert name]
Product Manager
Regulatory Branch [I or II]
Antimicrobials Division (7510C)

[Note: All EPA staff involved in the meeting should concur on this letter prior to its issuance.]