Proposed Process Improvements from EPA
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
Registration Division's New Process
The following outline five new processes that RD has developed and is implementing:
- Process for Fast Track Actions
- Schedule for Non-Fast Tracks
- Schedule for New Use (Not First Food Use)
- Schedule for New Active Ingredient/First Food Use
- IR-4 Application Process
The first process, relating to fast track actions, is in the form of a detailed narrative. Please note that the instructions for negotiating due dates that are contained here apply specifically to these short-turn around (90-day) actions and would not necessarily apply or be used in other situations.
The next three processes are in the form of project management schedules that the risk managers will be using to organize, schedule and track the work on non-fast tracks, new uses, and new a.i.’s.
Finally, we have included a summary of the new requirements for an IR-4 application.
Process for Fast Track Actions
(April 7, 2004)
- Pin-punch (Day1)
- IRSD separates actions not covered by fees from actions covered by fees (Day 1)
- All data sent to 86-5 screen (Day 1)
- Cover page for fee actions sent to expert team (Day 1)
- Expert team determines fee category (Day1-3)
- IRSD enters fee category into OPPIN/bill sent (Day 3)
- Cover page sent to PM Team (Day3)
- Cover memo arrives (Day 4)
- 86-5 results and data arrive and put together (app. Day 10)
- Address 86-5 results and ensure package is complete
- If passed 86-5 do completeness check, using standard checklist (attached) (Day 10-12)
- If failed 86-5 begin calls to resolve 86-5 problems; if possible do completeness check and use calls to resolve completeness issues also
- When action passes 86-5 and completeness check send to TRB
- However, if 86-5 problems cannot be resolved quickly or the package is substantially incomplete and cannot be corrected quickly (by the day the clock starts, i.e. within approximately 10 days), then:
- If you believe the package can be completed in a reasonable amount of time:
- Fill out the form for DD/OD review recommending that a time extension be negotiated that will be the number of days from when you place a call to the registrant stating what needs to be sent in to correct/complete the package until that information comes in, is correct, and has been through in-processing.
- While the recommendation is being reviewed, write letter stating deficiencies and prepare to call registrant to negotiate the new date.
- When you receive go-ahead on recommendation or different instruction-then proceed to handle the action accordingly.
- You must get written agreement from the registrant on the renegotiated due date (standard template letter can be provided in OPPIN–we are working on a draft). This letter will state that the number of days that will be added to the clock will reflect the number of days from when the registrant was notified of the deficiencies (state that date) until the information arrives in the Agency, is correct, and is ready for review. It should further state that the Agency will call the registrant when this happens to inform them of what the date is.*
- OPPIN can also scan-in registrant responses so that a permanent record is easily available.
- Always enter information on the new due date and the reason it was extended into OPPIN. When the package passes 86-5 and the completeness check send it to TRB or repeat this step as necessary or until move to 2 below!
- When you receive go-ahead on your recommendation or different instruction–then proceed to handle action accordingly.
- Always enter the information that the submission was denied and the reason into OPPIN.
- TRB will receive packages that have passed 86-5 and are judged to be complete by the PM teams. According to II. above, the PM teams will have taken no more than 21 days after the pin-punch date or the date of receipt of payment, whichever is later to accomplish this unless they have negotiated a new due date to account for the time it has taken the registrant to remedy any deficiencies. Thus, the clock should have 90 days remaining when the action arrives in TRB.
- TRB review
- If no further issues arise, e.g. with data deficiencies, TRB will complete its review and return the action to the PM team within 45 days.
- If minor problems arise that can be resolved quickly (within a week–total for all minor problems on one action), TRB will resolve these problems and get reviews done within the 45 days.
- If problems arise that cannot be resolved quickly as described in 2 above, e.g. entire studies are missing, the action will be referred back to the PM team for resolution and negotiation of a new due date. In these cases TRB will return copies of the standard completeness checklist with notes to the risk manager concerning what the deficiencies are.
- In cases where problems arise after the TRB review is done, TRB should write up the review
and provide it to the risk manager along with a statement of the problem to be resolved.
- If the TRB review is complete, the PM team will get the action out by the due date.
- If TRB has referred a problem package back to the PM team
- If the PM team believes the problems can be solved in a reasonable amount of time they will proceed as in II. E. 1 until such time as the package can be returned to TRB with the problems corrected and a new negotiated due date that reflects the time it took to get the problems resolved.
- If the PM team believes the problems cannot be resolved in a reasonable amount of time the PM team will proceed as in II. E. 2 and recommend the package be denied.
* We propose that IRSD develop a separate in-processing queue for items that are corrections/ additions to already submitted actions, so that these (presumably small) actions may move quickly through in-processing. If this were the case, we could have registrants use a code that would indicate this was in that category and they might be less concerned about the in-processing time. [Note: This has been done.]
New Procedures for an Application Associated with an IR-4 Tolerance Petition
Given the emphasis of PRIA on the Agency’s review time frames, EPA is placing a special focus on working with applicants to ensure that all registration applications are correct, complete and ready for review. When this is the case, the review and decision making processes can begin immediately and be completed without the loss of efficiency involved in starting and stopping work and waiting for corrections or additional information.
On this point, submissions from IR-4 are no different but can be considered a unique category, since their researchers typically develop the tolerance petition EPA considers in evaluating a food use registration application. However, IR-4 is not a chemical producer but works in collaboration with pesticide manufacturers and producers on minor crops. EPA is requesting that the data packages for IR-4 uses contain all of the necessary elements for the Agency’s consideration as would be needed for a registrant-generated submission. Notably, EPA intends to process and review the tolerance petition (i.e. IR-4's portion) concurrently with the registrant’s registration application and label.
Therefore, in order to receive tolerance petitions and registration applications which are complete and ready for Agency review, applications from IR-4 should contain:
- The tolerance petition
- Notice of Filing
- The completed application for registration (8570-1 form)
- Letter of authorization from the registrant which permits EPA to rely on their data
- All supporting data and labels
Adherence to this submission format will help to ensure that IR-4-company actions can be completed in the time frames called for under PRIA.