Guidance for AD Review of Applications for New Chemicals, New Uses, and Major Amendments

(9/20/01)

The Antimicrobials Division (AD) is implementing a new approach for processing applications for all new chemicals, new uses, and major amendments. This approach involves examining these applications when they are first received and determining how to most efficiently and productively process such applications. Recent experience has shown that, in many cases, applications can be evaluated without proceeding lock-step through the routine 40 CFR Part 158 data requirements, data reviews, peer review committees, and risk assessment document preparation. In fact, many applicants provide materials in their applications that may substitute for all or part of the documentation that the Agency typically prepares prior to granting a registration. Often, such materials can be carefully evaluated and referenced in Agency decision memoranda without recreating their content in Agency generated documents. This approach has proven to be particularly successful when the application is for a material that is naturally occurring, a commonly consumed food or known to be of very low toxicity. By carefully reviewing applications and determining "up-front" how best to use the information provided, resources can be conserved for other applications and activities where their use is more warranted and needed. The new approach will include, but not be limited to, determining:

(a)     whether the application contains any data waiver requests based on information or data that might substitute for some or all of the standard 40 CFR Part 158 data typically required for the uses requested. Examples of such information/data might include published papers in peer-reviewed scientific journals, studies conducted according to guidelines established by another regulatory authority (e.g., other Offices within EPA, other federal agencies, other countries, etc.), or predictions of toxicity based on structure/activity analyses, particularly when such analyses are supported by bridging data (e.g., subchronic oral toxicity; general metabolism).

(b)     whether the application contains any data analyses or risk assessment materials, such as hazard, dose response, exposure (including bounding estimates) and/or risk characterization documents, that may be reviewed by AD scientists in lieu of expending Agency resources to create de novo, possibly duplicative, documents. Such data analyses or risk assessment documents might be prepared by the applicant, a consultant to the applicant, expert panels (e.g., monographs prepared for Cosmetic Ingredient Reviews, GRAS self-determinations, etc.), other Offices within EPA, other federal agencies, other countries, etc.,

(c)     whether any OPP data summaries or reregistration materials for the active ingredient exist that may prove useful in evaluating the application;

(d)     the nature and extent of the Agency technical reviews that are needed, taking into account all waiver requests, data/data summaries, data analyses and risk assessment materials available; and

(e)     which parties outside of AD (such as other OPP divisions, EPA offices, federal or state agencies, or countries) should be consulted during the assessment of the application.

After the Product Manager (PM) has carefully screened the application he/she will discuss its content with the respective Branch Chief (BC). Following this discussion, the PM, with the BC concurrence, will schedule a meeting with the Division Director, Associate Division Director, regulatory BCs, and key Division science staff, as needed, for further direction, guidance and feedback.

If a formal RASSB review is needed (either partial or complete), the PM will send a single data package (rather than the customary splitting of the package by scientific discipline) to RASSB for science review. There, a science review team and "Task Leader" for the action will be assigned. This team will meet to develop an approach for conducting a comprehensive assessment. When this approach is approved by the RASSB Branch Chief and Team Leader(s), the Task Leader will monitor completion of the assessment and preparation of a single integrated document containing all science conclusions and recommendations. Negotiations, if needed, regarding the due date for the action will occur solely between the RASSB and Regulatory Branch Chiefs.

• Give guidance on data requirements, protocols, labeling, etc. as needed.



• Suggest that the applicant provide all relevant data or information pertinent to the use requested in their application package.



• Inform the applicant that waivers from routine 40 CFR Part 158 data requirements will be granted only when such waiver requests are adequately justified. Examples of materials that might be helpful in preparing data waiver justifications include published papers in peer-reviewed scientific journals or studies conducted according to guidelines established by another regulatory authority (e.g., other offices within EPA, other federal agencies, other countries, etc.), or predictions of toxicity based on structure/activity analyses, particularly when such analyses are supported by bridging data (e.g., subchronic oral toxicity; general metabolism).



• Inform the applicant that all submitted data analyses or risk assessment materials, such as hazard, dose response, exposure (including bounding estimates) and/or risk characterization documents, will be carefully reviewed by AD scientists. Such data analyses or risk assessment documents might be prepared by the applicant, a consultant to the applicant, expert panels (e.g., monographs prepared for Cosmetic Ingredient Reviews, GRAS self-determinations, etc.), other Offices within EPA, other federal agencies, or other countries. Be clear that relevance and quality should be the determining factors when deciding whether to submit such materials. Inundating the Division with large packages of irrelevant or poor-quality documents will only serve to delay the review process and defeat the purpose of submitting such materials for consideration.



• Prepare minutes of the meeting and forward to the applicant within 30 days. Meeting minutes should include basic information, such as attendees and affiliation, decisions reached at the meeting, and action items. Additional details on how to set up and record such meetings can be found in "Guidance for Pre-Application Meetings on new Active Ingredients and Major New Uses of Currently Registered Pesticides."

• The PM screens application for completeness per PR Notice 86-4. As part of the screening process, the PM will determine:

(a)     whether the submission contains any data waiver requests based on information or data that might substitute for some or all of the standard 40 CFR Part 158 data typically required for the uses requested. Examples of such information/data might include published papers in peer-reviewed scientific journals, studies conducted according to guidelines established by another regulatory authority (e.g., other Offices within EPA, other federal agencies, other countries, etc.), or predictions of toxicity based on structure/activity analyses, particularly when such analyses are supported by bridging data (e.g., subchronic oral toxicity; general metabolism).


(b)     whether the submission contains any data analyses or risk assessment materials, such as hazard, dose response, exposure (including bounding estimates) and/or risk characterization documents, that may be reviewed by AD scientists in lieu of expending Agency resources to create de novo, possibly duplicative, documents. Such data analyses or risk assessment documents might be prepared by the applicant, a consultant to the applicant, expert panels (e.g., monographs prepared for Cosmetic Ingredient Reviews, GRAS self-determinations, etc.), other Offices within EPA, other federal agencies, other countries, etc.

(c)     whether any OPP data summaries or reregistration materials for the active ingredient exist that may prove useful in evaluating the application.

• The PM prepares a proposal for completion of review that takes into account all materials provided within the application package. Examples of options the PM should consider: (1) use existing risk assessment materials as the full basis for assessment of risks, rather than requesting RASSB review; (2) use existing risk assessment materials as a basis for the assessment of certain exposures/risks (but not all situations), and request RASSB review of the remaining exposure/risk situations; or (3) request a full RASSB review, specifying the types of exposure and risk assessments needed. In some cases, particularly those involving complex exposure and/or toxicology issues, the best approach will be to ask RASSB (or AD’s scientific contractors) to fully review the risk assessment materials provided and determine their utility in evaluating the application.





• If the application passes the completeness screen, the PM , with BC concurrence, holds a meeting (generally within thirty days of receipt of the application) with regulatory BCs, Division Director, Associate Division Director, key Division science staff, and others as needed. At this meeting, the PM presents a summary of the application package and a proposal for completion of review. Management will provide feedback/approval. At this meeting, an initial determination will be made as to which parties outside of AD (such as other OPP divisions, EPA offices, federal or state agencies, or countries) should be consulted during the assessment of the application. Appropriate assignments for contacting such parties will be made at the meeting.





• Immediately following the meeting, the PM contacts the applicant to inform them of the process that will be followed in evaluating their submission. In particular, if a determination has been made that additional data or information will be needed to complete the assessment, the applicant should be notified as soon as possible to avoid unnecessary "cycles" of review.





•  If a RASSB review is needed, the PM assembles a single data evaluation review package (with one "bean sheet") and specifies the nature and extent of technical review needed. If only a partial review is to be conducted, a reduced review time may be negotiated with the RASSB BC.

• The RASSB Branch Chief (BC) and Team Leader(s) assign a science review team and a Task Leader to monitor the assessment. The Task Leader will discuss the assignment with the regulatory PM, as needed, to obtain clarification of the request and to communicate any issues that arise during the review process. The Task Leader and team will meet to evaluate the review package and develop a coordinated approach for completing the assignment. The Task Leader also obtains RASSB BC and Team Leader approval for the team’s proposed approach.





• The Task Leader monitors the progress of the review and assures that a single, integrated risk assessment document is prepared. The Task Leader schedules a close-out meeting with the science review team and RASSB BC and Team Leader(s) before sending the final risk assessment document to the PM. The Task Leader and all team members will sign and the RASSB Team Leader(s) and Branch Chief will concur on the final document before it is returned to the PM.

• The PM ensures that the key components of the regulatory decision are captured in a Decision Memo. The PM will also ensure that all assignments regarding communication/consultation with parties outside of AD (such as other OPP divisions, EPA offices, federal or state agencies, or countries) have been completed and taken into consideration in making the final decision. For new chemical decisions, a Fact Sheet must also be attached

 



• For new chemicals, the PM presents complete registration decision package to the BC, ADD and DD for discussion and approval. For new uses, the BC will concur on the memo prior to a registration decision being issued. For new chemicals, the OPP Director will concur.

 



• Upon approval of each registration decision, the PM will issue the appropriate documents to the registrant, the file, and to other EPA offices, as needed, as well as close out the tracking system (PRATS)
  

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