2017-18765. Pesticides; Draft Guidance for Pesticide Registrants on Notifications, Non-Notifications and Minor Formulation Amendments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

The Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) entitled “Pesticide Registration (PR) Notice 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments.” PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This particular draft PR Notice provides updated guidance to PR Notice 98-10, in line with current regulatory statutes (PRIA) to the registrant and other interested parties for notifications, non-notifications and minor formulation amendments.

DATES:

Comments must be received on or before October 6, 2017.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0671, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who are required to submit data under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), are required to register pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/​dockets/​comments.html.

C. How can I get copies of this document and other related information?

A copy of the draft PR notice is available in the docket under docket identification (ID) number EPA-HQ-OPP-2016-0671.

II. What guidance does this PR Notice provide?

This draft PR Notice provides guidance to the registrant concerning the process for notifications, non-notifications and minor formulation amendments. This proposed notice updates and clarifies the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products. This notice supersedes both PR Notices 95-2 and 98-10 in their entirety. As per 40 CFR 152.46, EPA may determine that certain minor modifications to a registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification or without notification to the Agency. Since the issuance of PR Notice 98-10, various regulatory and statutory changes have taken place. In particular, the Pesticide Registration Improvement Act (PRIA), the Pesticide Registration Improvement Renewal Act (PRIA 2), Pesticide Registration Improvement Extension Act (PRIA 3), and pending Pesticide Registration Enhancement Act of 2017 (PRIA 4) has resulted in a need for EPA to revise the notification procedures. Certain actions previously accepted under PR Notice 98-10 are now actions scheduled by the PRIA action tables. EPA is issuing this notice to align the notification program with the requirements of the Food Quality Protection Act (FQPA) and PRIA and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments, previously established in PR Notice 98-10. EPA believes these changes will be useful to registrants as it presents a clarified and consolidated explanation for accomplishing these registration changes. No significant impacts or costs are expected as a result of this proposed PR Notice. However, the Agency is especially requesting impacted parties to provide through comments available information on projected cost implications of this draft updated guidance. The Paperwork Reduction Act (PRA) burdens associated with revisions to the PR Notice are accounted for in the current ICR entitled: Application for New and Amended Pesticide Registration, OMB ICR 2070-0060; EPA No. 0277.17. As noted above, no increase or decrease in the current PRA burden inventory is anticipated.

III. Do PR Notices contain binding requirements?

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR Notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

Authority: 7 U.S.C. 136 et seq.

Dated: August 2, 2017.

Richard P. Keigwin, Jr.,

Director, Office of Pesticide Programs.