Pesticides; Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling

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 “Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling.” 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 draft PR Notice provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels. This draft PR Notice would update the guidance in PR Notice 2001-5.

DATES:

Comments must be received on or before August 2, 2016.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0242, 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:

Nikhil Mallampalli, Biological and Economic Analysis Division (7503P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-1924; email address: mallampalli.nikhil@epa.gov. 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) or 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 “Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling” and any related or supporting information are available in the docket under docket identification (ID) number EPA-HQ-OPP-2016-0242.

II. Overview of the Agency's Effort To Address Pesticide Resistance

Pesticides can be used to control a variety of pests, such as insects, weeds, rodents, bacteria, fungi, etc. Over time many pesticides have gradually lost their effectiveness because pests have developed resistance—a significant decrease in sensitivity to a pesticide, which reduces the field performance of these pesticides. The Agency is concerned about resistance issues and believes that managing the development of pesticide resistance, in conjunction with alternative pest-management strategies and Integrated Pest Management programs, is an important part of sustainable pest management. To address the growing issue of resistance and preserve the useful life of pesticides, the Agency is beginning to embark on a more widespread effort and several activities that are aimed at combating and slowing the development of pesticide resistance.

One such activity, which is the subject of this FR Notice, is today's release and request for comment on draft PR Notice 2016-X, “Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling.” Draft PR Notice 2016-X updates PR Notice 2001 and applies to all conventional, agricultural pesticides (i.e., herbicides, fungicides, bactericides, insecticides, and acaricides). This draft PR Notice focuses on pesticide labels and is aimed at improving information about how pesticide users can minimize and manage pest resistance.

Another such activity, involves the release of draft PR Notice 2016-XX, “Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship.” Draft PR Notice 2016-XX applies to herbicides, and communicates the Agency's current thinking and approach to address herbicide-resistant weeds by providing guidance on labeling, education, training, and stewardship for herbicides undergoing registration review or registration (i.e., new herbicide actives, new uses proposed for use on herbicide-resistant crops, or other case-specific registration actions). Draft PR Notice 2016-XX will also be published in today's Federal Register. In the future, the Agency plans to evaluate other types of pesticides (e.g. fungicides, bactericides, insecticides, and acaricides) to determine whether and what guidance may be appropriate for these types pesticides. If the Agency releases future guidance on these other types of pesticides, we plan to seek input from the public.

III. What guidance does this PR Notice provide?

Draft PR Notice 2016-X, which revises and updates PR Notice 2001-5, applies to all conventional, agricultural pesticides (i.e., herbicides, fungicides, bactericides, insecticides and acaricides). The updates in draft PR Notice 2016-X focus on pesticides labels and are aimed at improving information about how pesticide users can minimize and manage pest resistance. The draft PR Notice 2016-X updates PR Notice 2001-5 with the following three categories of changes:

• Provides additional guidance, and recommended format, for resistance management statements or information to place on labels.
• Includes references to external technical resources for guidance on resistance management (e.g., professional scientific societies, resistance action committees for different types of pesticides).
• Updates the instructions on how to submit changes to existing labels in order to enhance resistance management language.

This draft PR Notice also references draft revisions to Chapter 11.VI.G of EPA's Label Review Manual (LRM), which illustrates the generic format for resistance management labeling along with examples of various labeling scenarios that registrants may encounter. The Agency requests comments on the updates to this draft PR Notice and this chapter of the LRM.

IV. Do PR Notices contain binding requirements?

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decision-makers, as well as pesticide registrants. While the requirements in the statute 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.