Document ID: EPA-HQ-OPP-2012-0906-0001
Agency: epa
Document Type: Notice
Title: Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide Products
Posted Date: 2013-01-16T05:00Z

[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3418-3420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00560]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0906; FRL-9374-4]

Pesticides; Draft Guidance for Pesticide Registrants on Web-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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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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

[[Page 3419]]

Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 308-5891; fax number: (703) 308-2962; 
email address: arling.michelle@epa.gov@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

[[Page 3420]]

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.
[FR Doc. 2013-00560 Filed 1-15-13; 8:45 am]
BILLING CODE 6560-50-P