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

Current as of: 9/20/01

Executive Summary

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:


  1. 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).

  2. 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.,

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

  4. 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

  5. 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.

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  1. Pre-Registration Conference

  2. Top of Page

  3. Receipt of Application By Product Manager

  4. Receipt of Data Package in RASSB

  5. Final Regulatory Decision

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