2013-00560. Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide Products

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) titled “Web-Distributed Labeling for Pesticide Products.” 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 guidance concerning the process by which registrants can make legally valid versions of pesticide labeling available through the Internet. Web-distributed labeling would allow users to retrieve a streamlined version of the pesticide product labeling, containing the directions for use and necessary information related to the user's specific state and intended site of use. Shorter, relevant labeling could be clearer and easier for the user to understand, improving compliance with pesticide labeling requirements and thereby protecting human health and the environment from unintentional misuse of pesticides. Web-distributed labeling would also allow for more rapid updates to pesticide labeling, meaning risk mitigation measures and new uses can reach the user more quickly than under the current paper-based system.

DATES:

Comments must be received on or before April 16, 2013.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2012-0906, 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.htm.

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:

Michelle Arling, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; email address: [e-mail]@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 register and use pesticide products and to state regulators of pesticide products. 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. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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 submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Specific Areas for Comment. EPA has identified questions about the PR Notice on which the Agency would like to receive specific input from commenters. These questions and topic areas are presented below.

i. Would an appendix with sample master labeling and web-distributed labeling rendered output assist in understanding the PR Notice and how to follow the recommendations in the PR Notice?

ii. The PR Notice suggests that it “is targeted towards pesticide products marketed primarily to applicators for use in the course of commercial activity.” Please comment on the scope of coverage. Should the Agency expand or contract the targeted products? Are there alternate ways to describe the targeted products?

iii. Should the Agency consider combining the released for shipment date and the unique identifier into a single alpha-numeric combination? If so, why? Please provide suggested definitions for any proposed alternative.

iv. Should the released for shipment date and unique identifier have a standard location on the container or pesticide labeling? If so, where? If not, why?

v. Should EPA approve web-distributed labeling for one or some, but not all, uses listed on a product's labeling? If so, how would users know that no web-distributed labeling was available for their intended use?

vi. Should EPA consider only accepting WDL submissions to the Agency for review as electronic files?

vii. Please provide comments on the web-distributed labeling statements and their recommended location. Should they be located at the beginning of the directions for use? Should they be a separate section on the labeling, similar to the Agricultural Use Box that conveys information about the Worker Protection Standard? Would either approach make the user more likely to read and comply with the information?

viii. Please provide comments on the minimum functionality discussed in Unit IV. ix. Are the proposed standards reasonable? If not, please suggest alternative guidelines.

x. Please provide any other comments on the PR Notice. If you disagree with or do not understand any aspect of the PR Notice, please describe the area and an alternative that incorporates your suggestions.

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-2012-0906.

II. What guidance does this PR notice provide?

A. Background

Since 2007, the Agency has been exploring the feasibility and advisability of allowing registrants to make legally enforceable pesticide product labeling available to users via the Internet, an initiative referred to as “web-distributed labeling” (WDL). At the end of 2010, EPA initiated a “user acceptance pilot.” (75 FR 51058, August 18, 2010; EPA-HQ-OPP-2010-0632) The user acceptance pilot involved a simulation of a WDL Web site that users could visit and on which they could provide feedback. The user acceptance pilot did not involve any changes to existing pesticide labeling on containers or legally valid electronic versions of pesticide labeling. EPA also published a Federal Register notice which outlined EPA's positions on issues related to WDL and sought comment on a number of these issues. (75 FR 82011, December 29, 2010; EPA-HQ-OPP-2010-0648).

Based on its review of the comments and other feedback received from the Federal Register notice and the user acceptance pilot, EPA is proposing a voluntary approach to WDL that would allow registrants to distribute pesticide products with labeling that refers the user to the Web site from which the user may download legally valid, enforceable labeling. The container would still be accompanied by a physical copy of the EPA-accepted labeling sufficient for the correct use of the product, but a user could access the most current version of the state- and site-specific labeling from a Web site identified on the container label. Offering WDL while retaining the full labeling on or accompanying pesticide containers would allow users, registrants, and EPA to acquire a better understanding of the strengths and limitations of WDL and possibly serve as a transition to a system which relies more heavily on the Internet and other technologies to provide users with legally enforceable labeling. For example, registrants could determine whether specific types of products would be better suited to WDL and users could evaluate the relative benefit of WDL versus the current pesticide product labeling.

As considered by EPA, WDL would make available via the Internet site- and state-specific use directions for pesticide products as downloadable electronic files. To access this labeling, a user would visit the Web site identified on the pesticide label, enter information identifying the product, and select the intended state and use site. The Web site would return a streamlined version of the pesticide labeling containing the language applicable to all uses of the product, such as hazard statement and first aid, and the relevant state/site specific directions for use (e.g., application to cranberries in Maine). Sufficient labeling for the correct use of the product would still be available with the pesticide either on the container label or in accompanying material.

B. Overview of PR Notice

This PR Notice provides guidance about how EPA intends to implement WDL under this system. First, the PR Notice defines terms used related to WDL in this notice. It includes suggested language that registrants can use on the labeling affixed to or accompanying the pesticide container to reference the WDL portion of labeling. It recommends content, function, and security for the Web site associated with a product's WDL. Finally, the PR Notice suggests a process by which registrants can request that a product's labeling include WDL and outlines what information EPA expects to receive.

III. Do PR notices contain binding requirements?

The PR Notice discussed in this notice is intended to provide guidance to EPA personnel and decisionmakers 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.

List of Subjects

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests.

Dated: January 3, 2013.

Steven Bradbury,

Director, Office of Pesticide Programs.