PRN 91-1: Procedures for Voluntarily Requesting Deletion of Approved Uses from Registered Labels
April 5, 1991
At Section 6(f)(1) amended FIFRA provides that "a registrant at any time may request that any of its pesticide registrations ... be amended to delete one or more uses. Before acting on such request, the Administrator shall publish in the Federal Register a notice of the receipt of the request."
The 1990 Farm Bill further provides for a 90-day waiting period between publication of the notice of receipt and action on the request, in the cases of certain minor agricultural use pesticides.
The Agency has decided to delay approval of such requests for 90 days in all cases except where the delay would permit an otherwise avoidable risk to health or the environment to continue. The purpose of this 90-day period is to allow time for affected users to work directly with the registrants, before the use deletions are approved, to try to persuade them to withdraw their requests for use deletions. The Agency will take no action on amendments to delete uses if the requester withdraws the proposed amendment within the 90-day period following Federal Register publication. If a use deletion amendment request is not withdrawn, it will be approved routinely at the end of the 90-day period.
This notice defines the procedures for registrants to use when they with to request an amendment to delete one or more uses from an approved registration, and it summarizes the actions the Agency will take in response to such requests.
For the purpose of this notice, a 'use deletion' is defined as the removal of directions for a specific use (i.e., a crop, site, animal, etc.) and associated label language from a previously approved label text by amendment of the registration. Uses deleted by amendment under this procedure cannot be returned to the label later except through further amendments. When uses are deleted by amendment, the registrant is not obligated to address any outstanding data requirements triggered solely by the deleted uses.
This notice does not alter the Agency's long-standing policy of permitting registrants to omit approved uses from a particular version of a label. Unless, however, uses are deleted by amendment under this procedure, the registrant remains responsible for all data requirements triggered by previously approved uses, whether or not they appear on current labels.
All requests for use deletions must be submitted as proposed amendments on the EPA application form 8570-1.
The following elements must be included on this form:
- Product Registration Number
- Product Name
- Product Manager
- Company Contact
In the block headed "nature of the action", a complete itemized list of uses proposed for deletion. If more room is needed for the complete list, use continuation sheets.
Proposed use deletions should not be combined with other actions on the same amendment form; the special notice and waiting period requirements for use deletions will compromise the processing of other actions. If a registrant intends to delete uses from more than one registration (as, for example, from all those containing a particular active ingredient), multiple amendment forms are required--one for each product.
The amendment must be accompanied by five copies of the proposed revised labeling, marked up to highlight the specific language proposed for deletion.
All applications for amendments to delete uses must be sent to the Registration Division Product Manager to whom the product is assigned. If the use deletion is proposed in response to a reregistration data call-in, or any reregistration requirement imposed under FIFRA section 4, a photocopy of the application for amendment and the revised labeling should be sent along with other response materials to the Special Review and Reregistration Division.
Upon receipt of a complete application for amendment to delete approved uses, the Agency will prepare the required Federal Register notice. A notice reporting all recent receipts of use deletion amendments will appear in the Federal Register approximately monthly, and will identify the registrant on the application form. The notice will advise concerned parties to contact the registrant directly.
No action will be taken by the Agency on use deletion amendments until 90 days after Federal Register publication of notice of receipt. At that time, unless the application has been withdrawn, we will approve the amendment, and send the registrant notice of the approval and a stamped copy of the amended labeling.
The Notice was signed:
Herbert S. Harrison