Web-Distributed Labeling of Pesticides, 82011-82025 [2010-32036]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82011-82025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32036]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0648; FRL-8856-4]


Web-Distributed Labeling of Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is considering an initiative to make portions of pesticide 
labeling for certain products available electronically. Web-distributed 
labeling would allow users to download streamlined labeling specific to 
the use and state in which the application will occur. More concise 
labeling should increase users' comprehension and compliance with 
pesticide labeling, thereby improving protection of human health and 
the environment from risks associated with improper pesticide use. Web 
distributed labeling would also allow new labeling to enter the 
marketplace and reach the user more quickly than the current paper 
based labeling thus implementing both new uses and risk mitigation in a 
more timely manner. This notice describes potential approaches for a 
web-distributed labeling system and seeks stakeholder feedback on a 
variety of issues.

DATES: Comments must be received on or before March 29, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0648, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010- 0648. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Michelle DeVaux, Field and External 
Affairs Division, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-5891; fax number: (703) 308-2962; e-
mail address: devaux.michelle@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you use pesticide 
products occupationally, manufacture or distribute pesticides, regulate 
pesticide products, or provide pesticide labeling to users. Potentially 
affected entities may include, but are not limited to:
     Persons who manufacture, distribute, sell, apply, or 
regulate pesticide products, including agricultural, commercial, and 
residential products (NAICS codes 325320, 325311, 424690, 424910, 
926140).
     Establishments, such as farms, orchards, groves, 
greenhouses, and nurseries, primarily engaged in growing crops, plants, 
vines, or trees and their seeds (NAICS code 111).
     Establishments primarily engaged in providing pest control 
for crop or forestry production, or for exterminating and controlling 
birds, mosquitoes, rodents, termites, and other insects and

[[Page 82012]]

pests (NAICS codes 115112, 115310, 561710).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, 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 e-mail. 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.

II. Background

A. What Action is the Agency Taking?

    Since 2007, the U.S. Environmental Protection Agency (EPA or the 
Agency) has been exploring the feasibility and advisability of an 
initiative that would allow registrants to make portions of some 
pesticide product labeling available via the internet. The goals of 
this initiative, called web-distributed labeling, are (a) to provide 
streamlined labeling that contains only the most current labeling 
information pertinent to the state where a pesticide is to be used and 
for the particular intended use, and (b) to move new labeling (with new 
uses and/or new risk mitigation) into the hands of the user in a more 
timely manner. This streamlined labeling will omit unrelated directions 
and thus should reduce the overall length of labeling by a significant 
amount. EPA expects shorter, more focused labeling should improve 
readability, and user comprehension and compliance. Web-distributed 
labeling would be proposed initially as a voluntary option for 
registrants and would not be appropriate for all pesticide products.
    The web-distributed labeling initiative would create a system that 
would make the most current version of pesticide labeling available to 
purchasers and users via the internet and by other means. For certain 
types of pesticide products, portions of the labeling would no longer 
accompany the pesticide container. To obtain the additional labeling, a 
statement on the container label would direct a user to a specific Web 
site on the Internet. Once logged onto the Web site, the user would 
enter information identifying the product, the state where it would be 
applied, and the intended application site. The Web site would then 
provide the user with legally sufficient labeling appropriate for the 
proposed use, which the user could choose to download or print. Because 
it would contain only information relevant to the specified use, the 
labeling provided by the Web site would be ``streamlined'' compared to 
labeling currently on registered products, which often contain labeling 
information for dozens of uses. The Web site would only return state-
specific labeling, not EPA's ``master labeling.'' The web-distributed 
labeling system would also offer alternate delivery mechanisms for 
users who cannot or prefer not to access the Internet.
    The Agency has had many useful discussions of its web-distributed 
labeling initiative with stakeholders in both formal and informal 
settings. Through these discussions, EPA has identified the critical 
elements of a web-distributed labeling system for distributing 
information to pesticide users via the internet. These discussions have 
also raised a number of issues on which EPA seeks further comment.
    This Notice is organized into seven units, starting with this 
Introduction. Unit II. provides background information on the history 
of the initiative and particularly the Agency's goals in pursuing this 
new technique for conveying enforceable labeling information to 
pesticide users. Unit III. discusses the significant elements of web-
distributed labeling and Unit IV. identifies issues for further 
consideration. Finally, Unit VI. describes a proposed path forward for 
determining whether, when, and how to begin implementation of the web-
distributed labeling initiative.

B. What is the Agency's Authority for Taking this Action?

    EPA is taking this action under the authority of FIFRA, section 
20(a). This section provides that ``The Administrator shall undertake 
research * * * with * * * others as may be necessary to carry out the 
purposes of [FIFRA].'' Here EPA is seeking to input from stakeholders 
that will help EPA assess whether to continue consideration of a web-
distributed labeling program. This information is essential to 
understanding whether a web-distributed labeling system would improve 
users' compliance with pesticide labeling, thereby reducing risks to 
human health and the environment.

III. Overview

    This unit discusses the legal framework within which EPA and the 
states regulate the format and content of the labeling on pesticide 
products; the kinds of problems that exist with pesticide labeling; and 
how a web-distributed labeling system would address those problems.

A. Legal Framework

    1. Federal Authority. A web-distributed labeling system would be 
implemented under EPA's existing authority and would follow essentially 
the same process as is currently used. EPA regulates pesticide products 
under the authority of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). FIFRA establishes a pre-market review and 
approval system called ``registration.'' With limited exceptions, no 
pesticide may be sold or distributed

[[Page 82013]]

in the United States unless EPA has first issued a registration for the 
product. As part of the registration process, EPA reviews and approves 
the labeling of pesticide products. EPA may also review amendments to 
labeling proposed by the registrant, such as a change in use site or 
application rate. Labeling describes how a pesticide may be used safely 
and effectively. Traditionally, labeling has been limited to what is 
attached to or accompanies the product and is provided to users at the 
point of sale, commonly as a leaflet or booklet. The ``misuse 
provision'' in FIFRA Sec.  12(a)(2)(G) prohibits the use of a pesticide 
``in a manner inconsistent with its approved labeling.'' In effect, the 
labeling is the law.
    Because FIFRA requires users to follow the requirements and 
limitations in labeling, the labeling for a pesticide product becomes 
the primary mechanism by which EPA communicates enforceable 
requirements to pesticide users about how to use a product safely and 
effectively. FIFRA Sec.  2(p) clearly allows for both a ``label'' and 
``labeling.'' The term ``label'' means ``the written, printed, or 
graphic matter on, or attached to, the pesticide or device or any of 
its containers or wrappers.'' ``Labeling'' means ``all labels and all 
other written, printed, or graphic matter accompanying the pesticide or 
device at any time; or to which reference is made on the label or in 
literature accompanying the pesticide or device, except to current 
official publications of the Agency, United States Department of 
Agriculture, Department of the Interior, and Department of Health and 
Human Services, State experiment stations, State agricultural colleges, 
and other similar Federal or State institutions or agencies authorized 
by law to conduct research in the field of pesticides.'' 7 U.S.C. 
2(p)(2). Although not common currently, labeling sometimes uses a 
reference to other enforceable documents that do not physically 
accompany the container, as evidenced by the Worker Protection Standard 
and Bulletins Live (for threatened and endangered species and their 
habitats).
    A registrant may distribute or sell a registered product with the 
composition, packaging, and labeling currently approved by the Agency. 
40 CFR 152.130(a). Likewise, a registrant may distribute or sell a 
product under labeling bearing any subset of the approved directions 
for use, provided that in limiting the uses listed on the label, no 
changes would be necessary in precautionary statements, use 
classification, or packaging of the product. 40 CFR 152.130(b).
    2. State Authority. EPA does not anticipate that a web-distributed 
labeling system would affect state authority with respect to pesticide 
regulation in any way. Section 24(a) of FIFRA provides that a state may 
regulate the sale or use of any federally registered pesticide or 
device in the state, but only if and to the extent the regulation does 
not permit any sale or use prohibited by FIFRA. Section 24(b) holds 
that such state shall not impose or continue in effect any requirements 
for labeling or packaging in addition to or different from those 
required under FIFRA. State lead agencies have the final authority to 
approve marketed product labeling submitted by registrants for sale and 
distribution in their states. Under state laws in every state, sale or 
distribution of a pesticide product may not occur within a state until 
the state registers the product.
    Section 26 of FIFRA provides that a state shall have primary 
enforcement responsibility for pesticide use violations provided the 
state has adopted adequate pesticide use laws, has adopted and is 
implementing adequate procedures for the enforcement of such state laws 
and regulations, and will keep such reports showing compliance with the 
conditions listed above.

B. What Problems is Web-Distributed Labeling Intended to Solve?

    Many people have voiced criticisms about the labeling currently on 
many pesticide products. Among other problems, critics complain that 
labeling attempts to convey too much information and that the existing 
process for implementing labeling changes is too slow. Both types of 
problems can result in the use of pesticides in ways that, EPA has 
determined, cause risks to human health and the environment and that 
might be avoided by changing the way users obtain labeling. In 
particular, critics note that because the labeling of a single product 
may contain precautions and detailed use directions for multiple uses, 
the labeling is often quite long--sometimes exceeding 50 pages in 
length. As a consequence, pesticide users complain that it is difficult 
to find all of the relevant parts of the labeling, and some state 
regulatory officials suspect that overly lengthy labeling materials has 
diminished user compliance rates. Further, the Agency is concerned with 
how much time can elapse between EPA's approval of the addition of both 
new uses and new restrictions on pesticide use and when products 
containing such statements actually reach users' hands. Many factors 
contribute to the delay including the need for approval by state 
regulatory officials following EPA approval and the long lead time 
involved with printing new labeling and getting the new versions on 
products in the marketplace. More timely implementation of approved 
labeling would reduce risk when new risk mitigation measures have been 
registered. These delays also mean that identical products bearing 
different versions of labeling are often available simultaneously in 
the marketplace. State officials and users have complained that 
different but legal versions of product labeling lead to confusion of 
users and challenges for enforcement.

C. Web-Distributed Labeling as a Solution

    State regulators suggested that EPA consider web-distribution of 
pesticide labeling as a solution to some of the problems identified. In 
response, EPA initiated an internal workgroup to explore the concept of 
web-distributed labeling. The workgroup had extensive outreach to and 
conversations with stakeholders. EPA found that if accepted by users 
web-distributed labeling appeared feasible, and it could have benefits 
for many stakeholder groups.
    For pesticide users, a new web-distributed labeling system would 
provide simplified labeling. Under the new system certain information 
on the label would be required to be attached to the container and the 
user would be required to obtain and follow a copy of state- and site-
specific use directions and precautions for the product from an 
alternate source, either the Internet or a toll-free phone service that 
would mail or fax a copy of the labeling to the user. To obtain full 
use directions specific to the state and crop the product is intended 
to be applied, the container label would require a user to go to a Web 
site on the Internet, enter the EPA product registration number, the 
state where it would be applied, and the application site in order to 
download streamlined use directions and associated labeling. The user 
would be required to comply not only with restrictions appearing in the 
label securely attached to the container and in labeling accompanying 
the container, but would also have to obtain and follow those in the 
web-distributed labeling available from a referenced Internet source or 
toll-free number.
    The web-distributed labeling generated by the user's specification 
of a particular use and state would eliminate information that is not 
relevant and would dramatically

[[Page 82014]]

simplify labeling. Most web-distributed labeling could then contain 
relatively brief, very specific use directions and precautions that 
would not be obscured by information applicable to use on other sites 
or with other legally sufficient application methods. Moreover, a web-
distributed labeling system could make additional information available 
to users that they could find valuable, e.g., rate calculators or 
demonstration videos. The users ultimately would have in their 
possession all pertinent labeling information.
    For pesticide regulators (i.e., EPA and the states) whose mission 
is to protect human health and the environment, web-distributed 
labeling could bring at least two primary benefits in terms of 
protecting human health and the environment. First, EPA thinks that 
users would more readily understand the streamlined labeling available 
through a web-distributed labeling system and therefore would be more 
likely to comply with the requirements in the labeling. Second, by 
providing use-direction labeling electronically, rather than as a 
printed document that accompanies the pesticide container, registrants 
could significantly reduce the amount of time between when EPA approves 
a change to pesticide labeling and when the labeling reflecting the 
change actually reaches users in the field thus reducing risk in a more 
timely manner.
    For registrants, web-distributed labeling could reduce printing 
costs and the time needed to implement new uses. When pesticide 
labeling changes under the current system, registrants have to arrange 
for printing of new labeling material to accompany each newly released 
container of pesticide. Many products require a large, multi-page 
booklet attached to the container. Under a web-distributed labeling 
system, the process for developing new printed labeling could be more 
orderly and less costly. Note: The cost of printing labeling (in a 
streamlined form) would be transferred to the user. Finally, for 
pesticide enforcement staff (states and EPA regions) web-distributed 
labeling could have several advantages over the current system. First, 
enforcers could find higher rates of user compliance with pesticide 
labeling and faster implementation of risk mitigation measures. 
Enforcers would also benefit from fewer versions of pesticide labeling 
in the marketplace because the portion of labeling that changes most 
often would not be attached to the container. In addition, web-
distributed labeling that is state-specific would also make it easier 
for state enforcement personnel to verify that a user is complying with 
a state-approved version of the labeling.
    EPA requests stakeholders to consider the following:
     How would web-distributed labeling benefit your 
organization? What problems with pesticide labeling could it address?
     How could audiences that do not traditionally use the 
label, such as farm workers, farm worker advocacy organizations and 
environmental interest groups, benefit from web-distributed labeling?
     What resource savings could be achieved in your 
organization if web-distributed labeling were implemented? What costs 
would be incurred?
     Please provide any general comments about the concept of 
web-distributed labeling and the potential benefits to stakeholder 
groups including pesticide users, registrants, regulators, farm worker 
advocacy groups, environmental interest organizations, and the public.

IV. Overview of Web-Distributed Labeling

 A. The Current System

    In most cases, registration of a pesticide product begins with 
approval by EPA of a ``master label,'' which is EPA-approved labeling 
that contains the complete set of precautions and use directions for 
all approved uses of the product. This is followed by state approval of 
a ``marketed label,'' which is specific labeling associated with a 
product as it will be sold in a state; the ``marketed label'' must be 
the same as (or a legally sufficient subset of) the approved FIFRA 
master label.
    1. EPA's Registration Process. EPA authorizes the use of pesticide 
product primarily under section 3 of FIFRA (federal registration). 
Under this provision, EPA is responsible for ensuring that approved 
pesticide products will not pose unreasonable adverse effects to human 
health or the environment. EPA defines risk standards, identifies data 
studies required to evaluate these risks, and specifies the 
requirements for product labeling.
    Applicants for registration are responsible for developing the 
formulation of a product, providing data from required studies), and 
providing product labeling which details how a product is to be used. 
Much of the labeling content is prescribed based on the chemical and 
toxicological properties of the product, for example if a product is a 
severe skin irritant, it is labeled as toxicity category II (see 40 CFR 
156 and various Pesticide Registration Notices). It is left to the 
applicant to propose the directions for use describing the application 
timing, method, and equipment, use rates, re-treatment intervals, 
maximum quantities per application and year, and other restrictions. 
These use directions are used to define the exposure parameters in a 
risk assessment. EPA's registration decisions are based on conducting a 
risk assessment of the pesticide developed using environmental fate, 
toxicology, and ecological effects data provided by an applicant as the 
applicant proposed the pesticide be used (i.e., as specified in the 
proposed product labeling.) Following EPA's risk assessment, a detailed 
review is conducted to ensure that the proposed labeling adheres to 
current EPA regulations and policies. Issues identified during the risk 
assessment can often be mitigated by adjusting the labeling on the 
product prior to approval.
    When EPA has completed a review of the application for registration 
and finds that the product will not pose unreasonable adverse effects 
to human health or the environment, the product is registered and EPA 
approves a master label. The master label contains a complete set of 
precautions and use directions for all approved uses of a product, but 
is not generally the label that accompanies the pesticide container. 
The master label is used to develop marketed product labeling 
(discussed below).
    More information on EPA's pesticide registration process is 
available at https://www.epa.gov/pesticides/regulating/registering/index.htm.
    2. State Registration. All states have a state pesticide 
registration requirement under their respective state laws. Therefore, 
in addition to registering all pesticides with EPA under FIFRA for 
approval of a master label, pesticide companies must also receive 
approval from a state in order to distribute, sell, offer for sale, and 
in some cases use, the product in that state. The process to obtain a 
state registration can vary greatly among states, as can the level and 
type of review conducted by the state lead agency. While some states 
may simply record the existence of each marketed label, other states 
may do a detailed comparison of the ``marketed label'' to the EPA 
``master label,'' or conduct extensive risk assessments or other 
reviews.
    In addition to varying greatly in how they register pesticide 
products and approve labeling, states vary greatly in how they manage 
labeling and other supporting documents. Because of available resources 
or statutory

[[Page 82015]]

requirements, some states may manage pesticide labeling in their files 
in hard-copy format. Other states receive, review, and/or manage 
pesticide labels in electronic format, including sophisticated online 
portals for registrants to submit online pesticide registration 
applications, electronic documents, and payments. Regardless of how 
they manage labeling as part of their state pesticide registration 
program, most state lead agencies agree that the labeling found on or 
accompanying the product in the channels of trade, despite the version, 
is the labeling that is enforceable in instances of misuse.
    3. Pesticide Labeling Production Process. Despite the complexity 
and time involved in getting a pesticide product label registered with 
both EPA and states, registration is only one aspect of moving a 
product from initial concept to final use by applicator. Even focused 
simply on the labeling aspects, the overall production process 
encompasses product development, regulatory approval of the master 
label by EPA, development of the marketed label, regulatory approval of 
the marketed label by states, printing of state approved marketed 
labels, filling and labeling of product containers, distributing 
product to the point of sale, and providing post sale product 
stewardship to both applicators and enforcement staff.

B. History of Development of Web-Distributed Labeling

    State officials involved in pesticide regulation deserve credit for 
initiating EPA's consideration of a web-distributed labeling system. 
The State-FIFRA Issues Research and Evaluation Group, a group of 
representatives from State organizations responsible for state level 
regulation of pesticides, produced two issue papers on the electronic 
submission and distribution of pesticide labeling. EPA's Office of 
Pesticide Programs formed an e-label review workgroup, tasked with 
exploring ways of using technology to make the pesticide labeling 
submission, review, approval, and dissemination process more efficient. 
In the summer of 2007, the Association of American Pesticide Control 
Officials (AAPCO), the national association representing State lead 
agencies for pesticide regulation, presented the idea for web-
distributed labeling to the director of the Office of Pesticide 
Programs.
    After receiving the request to consider web-distributed labeling, 
EPA formed an internal workgroup with members from the Office of 
Pesticide Programs, Office of Enforcement and Compliance Assistance, 
Office of General Counsel, Regional Offices, and 2 state 
representatives. The workgroup discussed the mechanics of web-
distributed labeling and how it would complement ongoing label 
improvement programs. The workgroup conducted extensive stakeholder 
outreach to individuals and associations to describe the concept of 
web-distributed labeling and to solicit stakeholder feedback. Using the 
stakeholders' input, the EPA internal workgroup developed discussion 
papers to describe some of the details around specific elements of web-
distributed labeling.
    In May, 2008, EPA requested formal feedback on web-distributed 
labeling from the Pesticide Program Dialogue Committee (PPDC), a 
federal advisory committee for the Office of Pesticide Programs. In 
response, a PPDC workgroup was formed to review and respond to the 
discussion papers developed by EPA. The PPDC workgroup includes 
representatives from user and grower groups; public interest groups; 
trade associations; industry; state, local, and tribal government; 
educational organizations; federal agencies; and others. From October 
2008 through October 2009 the PPDC web-distributed labeling workgroup 
met to discuss and provide comment on papers. A full listing of the 
meetings and papers considered is available at: https://epa.gov/pesticides/ppdc/distr-labeling/.
    In October 2009, the PPDC workgroup discussed a pilot for web-
distributed labeling that would allow users to test the functionality 
of one or several web-distributed labeling Web sites using mocked-up 
labeling. The pilot would be conducted without any actual labeling 
changes. Based on the feedback received from the PPDC workgroup, EPA 
decided to shift the focus of the pilot from developing Web sites 
capable of delivering web-distributed labeling to soliciting user 
feedback on the concept of web-distributed labeling. The pilot is 
discussed in further detail in Unit VI. of this Notice. EPA invited 
participation in it customer acceptance pilot through a Federal 
Register Notice published on August 18, 2010. See https://www.gpo.gov/fdsys/pkg/FR-2010-08-18/pdf/2010-20449.pdf.

C. Web-Distributed Labeling Elements

    1. Scope of Web-Distributed Labeling. A primary consideration 
before web-distributed labeling could be implemented is which products 
should be eligible to participate. EPA does not anticipate that all 
products would be eligible for web-distributed labeling initially.
    EPA is not inclined to limit products' eligibility for web-
distributed labeling based on how the product is registered or 
distributed. Web-distributed labeling would be available for otherwise 
eligible products whether they are sold by registrants directly or 
through another company as supplemental distributor products.
    Both unrestricted (general use) and restricted use products (RUPs) 
may be appropriate for web-distributed labeling. General use products 
are accessible to all applicators and can be used in agricultural, 
residential, and industrial settings, among others. RUPs are available 
only to applicators that have been certified as competent by a state, 
tribal, or federal agency, and applications are generally conducted as 
part of the applicator's primary occupation rather than incidentally. 
Both types of products would benefit from streamlined labeling 
available through web-distributed labeling. In general, EPA believes 
that RUP applicators, because of their training, certification, and 
awareness of legal responsibility to comply with all labeling, are more 
likely to comply with the requirement to obtain web-distributed 
labeling. However, many professional applicators also use general use 
products and would also comply. Therefore, EPA would invite 
manufacturers of both general use products and RUPs to participate in 
web-distributed labeling.
    EPA proposes to limit the scope of products eligible to use a web 
distributed labeling system to those that are used as part of a money-
making or business operation, or as a public regulatory function. 
Residential, consumer use products would not be included in web 
distributed labeling and would continue to be distributed with the full 
labeling accompanying the product container. Registrants may choose to 
post the labeling for residential products to the Web sites, however, 
so that consumers may obtain some of the benefits of web distributed 
labeling, such as viewing text in a larger font size.
    Further consideration of the potential scope of web-distributed 
labeling is available at https://epa.gov/pesticides/ppdc/distr-labeling/oct08/wdl-scope.pdf.
    EPA requests feedback on the following:
     What should be the scope of products under consideration 
as eligible for web-distributed labeling?
     What criteria should be used to determine which types of 
pesticides should be eligible for web-distributed labeling?

[[Page 82016]]

    2. Voluntary vs. Mandatory Participation. EPA thinks that 
participation in the web-distributed labeling system should initially 
be voluntary. As discussed above, EPA would invite both general and 
restricted use pesticide manufacturers to participate in the program. 
Once web-distributed labeling is established and has operated for a few 
years, the Agency would expect to evaluate its impact on pesticide 
safety and may consider implementing a mandatory system if appropriate.
    EPA requests comments on the following:
     What are the benefits and drawbacks associated with 
voluntary and mandatory participation in web-distributed labeling?
     How would pesticide registrants, states, and users benefit 
from a voluntary web-distributed labeling system?
     How would a voluntary system negatively affect these 
groups?
     Why would stakeholders support mandatory participation in 
a web-distributed labeling system?
     What would be the drawbacks of a mandatory system?
    3. What's on a Pesticide Container and on the Web-Distributed 
Labeling Web site? Implementation of web-distributed labeling would 
require decisions be made regarding which types of information would 
appear on the label securely- attached to the container, which would 
appear in labeling accompanying the container, and which would be web-
distributed, or available through alternate delivery mechanisms. 
Currently, for virtually all products, all labeling is attached to the 
pesticide container or distributed at the point of sale with the 
product. The labeling includes all information required by FIFRA and 
EPA's regulations. Web-distributed labeling would be used for state-
approved, marketed product labeling, not EPA's master labeling.
    Under web-distributed labeling, EPA would partition the label and 
labeling elements according to whether they would be securely-attached 
to the container, accompanying the container, or in web-distributed 
labeling. The securely-attached or accompanying label and labeling 
would contain all safety and product identification information; state- 
or site-specific use direction information would be available through 
web-distributed labeling. Users accessing the labeling through an 
alternate delivery mechanism would receive a copy of the labeling 
containing all information in the securely attached, in the 
accompanying labeling, and available via the web-distributed labeling 
system. A full list of the components that would appear on the label 
and those components that would be available through the web-
distributed labeling system can be found at: https://epa.gov/pesticides/ppdc/distr-labeling/oct08/container-label.pdf.
    i. Information Securely Attached to the Container. In accordance 
with FIFRA Sec.  2(q) and 40 CFR Part 156, specific label elements must 
be on a label securely-attached to the container. The same requirements 
would apply to a web-distributed labeling system. Thus, the following 
elements must be found on the label securely-attached to the container: 
Directions for use or a reference statement to directions for use found 
elsewhere in labeling; use classification (Restricted Use Product 
statement); violation of federal law statement; product registration 
number; signal word; Worker Protection Standard referral statements; 
storage and disposal requirements; product establishment number; brand/
product/trademarked name; ingredient statement; net weight or contents; 
skull & crossbones/POISON and statement of practical treatment if 
highly toxic; name and address of producer or registrant; warning or 
caution statement adequate to protect health and the environment (by 
regulation, this requires physical and chemical hazard information, and 
human health and environmental precautionary statements); and (for 
labels of products for export only) ``Not registered for Use in the 
United States of America.
    Under web-distributed labeling, a ``released for shipment date'' 
would be required to appear on the container label. The released for 
shipment date should appear with the registration number on the product 
container label and its purpose is detailed in Section B.3.
    In addition to the existing requirements outlined above, under web-
distributed labeling EPA would require a container label to include a 
reference statement, likely under the heading ``Directions for Use'' 
where the violation of federal law statement appears, that reminds 
users they are bound by the directions on the container as well as 
those included in the web-distributed labeling. The language requiring 
users to obtain and comply with web-distributed labeling would be 
similar to:
    ``You must obtain additional labeling, which includes directions 
for use, from [insert the Web site address for the web-distributed 
labeling system] or by calling [insert the toll-free telephone number]. 
This additional labeling must be dated after the ``released for 
shipment date'' appearing [indicate location on container]. You must 
possess a copy of this additional labeling at the time of application. 
It is a violation of federal law to use this product in a manner 
inconsistent with its attached label or the additional labeling 
obtained in one of the methods listed above.''
    While not required to be attached to the container, users and the 
environment would benefit from additional information attached to or 
physically accompanying the container. For example, since pesticides in 
their containers move in the channels of trade, it is important to 
provide basic information regarding safe storage, handling, and 
disposal of the product, as well as what to do in case of accidents and 
spills, to anyone who may come in contact with the pesticide, such as 
distributors, applicators, handlers, medical providers, or first 
responders.
    ii. Web-Distributed Labeling Content. Web-distributed labeling 
would encompass all labeling information not required to be affixed to 
the container. In order to minimize costs of reprinting product labels, 
pesticide companies would not want to put information in the label or 
in the labeling physically accompanying the container that would be 
likely to change frequently. The web-distributed labeling would include 
components of the labeling that are specific to the type of 
application, such as engineering controls, environmental hazards, use 
directions and advisory statements. There has been discussion about the 
concerns for putting the target sites and pests on the label that is 
securely attached or accompanying the container. However, any change in 
site or pest would require manufacturers to print new labels and have 
them in the channels of trade prior to making any changes to the web-
database. If these items changed frequently and they were securely 
attached or accompanying the container, the benefit of web-distributed 
labeling would be reduced greatly.
    EPA requests comments on the following:
     Do you agree with the proposed content that would be 
included on the web-distributed portion of the labeling?
     Should other content be included on the container-affixed 
label?
    4. Lifespan of Web-Distributed Labeling. This unit addresses how a 
system for web-distributed labeling would affect the length of time 
that pesticide labeling would be valid. EPA proposes to adopt an 
approach that would operate in essentially the same manner as the 
current, paper-based system.

[[Page 82017]]

    i. The Current System. The current, paper-based system generally 
does not result in a fixed ``lifespan'' for pesticide labeling--the 
duration of time over which a user may lawfully use a pesticide 
according to its labeling. Users may use a pesticide consistent with 
the labeling that accompanied it when the pesticide was obtained for as 
long as they have the pesticide or unless EPA issues an order that 
affects such use. FIFRA Sec.  12(a)(2)(A) makes it unlawful for a 
person to detach or alter the labeling on a registered pesticide 
product. Consequently, each time that a pesticide is used up and the 
container is disposed of, the user must get a new container with new 
labeling that he cannot alter or deface. This means that the labeling 
accompanying a container is legally valid only for as long as the user 
possesses the specific product container and is only valid with respect 
to the quantity of pesticide in that container.
    Currently, when EPA approves changes to a registrant's labeling, 
the registrant places the revised labeling on newly produced quantities 
of the pesticide within 18 months of the approval. These time periods 
allow application of the new labeling in the production process over an 
extended timeframe rather than requiring the registrant to collect, 
relabel, and redistributed the product with an amended label. Users 
buying product containers bearing the revised labeling thus become 
subject to the new requirements.
    In sum, pesticide users have come to expect that they will be able 
to use a pesticide according to the labeling accompanying the product 
container until the all of the pesticide has been used up. This 
expectation holds even if EPA requires changes to the labeling on 
quantities of the identical product when sold in the future.
    ii. The Proposed System. One premise of a web-distributed labeling 
system is that labeling would not physically accompany the pesticide 
product at the time of sale. Instead, material would become 
``labeling'' because the container label would refer to it and make it 
legally binding. Referenced labeling would be obtained separately from 
the product container. Once obtained, such labeling applies to all 
products that refer to it, not necessarily just a single specific 
container as is the case for the paper-based system. One result of this 
is if a user possesses multiple containers of the same pesticide 
product, it may not be necessary to require the user to obtain separate 
labeling for each discrete container of a pesticide he possesses.
    The attenuation of the labeling and the product container creates a 
potential problem--old, out-of-date labeling could be associated with 
newly produced quantities of a pesticide by virtue of having the same 
registration number. Further, just as now happens under the current 
paper-based system, when EPA amends the labeling of a pesticide product 
to incorporate new protections for human health or the environment, 
those protections should apply prospectively to users who purchase 
products sold after the date of the amendment. But, because web-
distributed labeling is not linked to particular containers, the new 
system must ensure that users do not continue to follow old labeling 
when using new products.
    To address this situation, EPA proposes the following approach. EPA 
would require product containers to bear a statement that the specific 
container was ``released for shipment on [date]'' and also require the 
user to obtain a valid version of the labeling from the Web site on or 
after that date. The date on which a product was released for shipment 
is the date on which the registrant made a pesticide product available 
for sale or distribution to another person. (40 CFR 152.3) Finally, the 
container label would specify that the product could be used only in 
accordance with an approved version of the labeling obtained after the 
production date from the Web site listed on the labeling. In addition, 
labeling obtained would include a prominent statement of the date on 
which the labeling was generated, along with a statement that the user 
could use the labeling only if the product container indicated it had 
been released for shipment before the date in the labeling. Once a 
product is in the channels of trade and the container label changes, it 
would be treated the same way existing stocks are treated under the 
current system, and dealers could lawfully sell the product with 
labeling that had been superseded by a new version.
    The consequence of this approach would be that a pesticide could 
lawfully be used according to any version of the labeling that a user 
obtained after the date on which the product was released for shipment. 
Once the pesticide in the container was used up (or disposed of), if 
the user wanted an additional quantity of the pesticide, the user would 
need to obtain a new container of the pesticide labeled with a new 
``released for shipment on [date].'' Labeling that predated the date on 
the newly obtained quantity of pesticide would no longer be valid. In 
effect, this approach would give web-distributed labeling an 
indeterminate lifespan equal to the amount of time a user takes to use 
up the pesticide material--the same lifespan as under the current 
system. (As with the paper-based system, EPA would retain the authority 
under FIFRA to cancel or suspend the registration of a pesticide using 
web-distributed labeling, and could further prohibit use of existing 
stocks, if deemed necessary.)
    EPA requests comments on the following:
     What are the benefits and drawbacks associated with tying 
the lifespan of web-distributed labeling to a ``released for shipment 
date?''
     What are the benefits and drawbacks of a requirement for 
web-distributed labeling to have a specific expiration date?
     If a specific expiration date is recommended, should it be 
a firm date or a set time period after the product is released for 
shipment? Why?
    5. Functionality and Hosting of Web-Distributed Labeling Web 
site(s). This section presents EPA's thoughts on the web-distributed 
labeling Web site functionality and Web site hosting. The functionality 
section describes in a general sense what users would be able to do if 
the web-distributed labeling Web site were available. The hosting 
section presents several basic concepts the EPA has discussed for 
housing and maintaining the software and hardware that support the web-
distributed labeling Web site. EPA has differentiated the major 
components of Web site functionality in two categories: Critical 
components and desirable components. The critical components are those 
that EPA believes are necessary for implementing a useable web-
distributed labeling Web site; without these critical components, the 
key benefits described earlier in this Notice may not be realized. The 
desirable components are those that EPA believes would add value to a 
web-distributed labeling Web site; however, these desirable components 
are not necessary for implementing a useable web-distributed labeling 
Web site. A full discussion of the proposed functionality is available 
at https://epa.gov/pesticides/ppdc/distr-labeling/jan09/functionality.pdf.
    i. Critical Components of the Web site(s). The first three critical 
components relate particularly to users of pesticide products. Users 
must be able access web-distributed labeling. This would include 
searching the web-distributed labeling database by the registration 
number, the state in which the application is to be made, and the use 
site to which the application is to be made. By specifying these search

[[Page 82018]]

criteria, the user would choose the labeling he/she wishes to view. 
Second, the Web site must allow all users to view both current and 
historic versions of product labeling for pesticides in the web-
distributed labeling system. This would include the most recently 
approved version of the labeling, as well as all versions of web-
distributed labeling that had been previously approved and available 
for download so that users could access versions of the labeling that 
correspond to a container purchased at an earlier date and compare 
historic and current versions of labeling, and inspectors could access 
all versions of labeling that corresponds to a container. Finally, the 
Web site must have user-friendly interface and be easy to navigate. 
Some people that would use a potential web-distributed labeling Web 
site might have little to no experience navigating the Internet. In 
order to encourage utilization of the web-distributed labeling system 
Web site, it is important that it be intuitive and easy for an 
inexperienced Internet user to navigate.
    There are also critical components related to the posting of 
labeling and security of the Web site. In order to house accurate 
current and historical versions of labeling, the web-distributed 
labeling Web site must allow participating registrants (or agents with 
appropriate access rights) to upload new versions of web-distributed 
labeling. This component will ensure that only authorized users are 
permitted to make timely updates to web-distributed labeling Web site 
content. In addition, the web-distributed labeling Web site must employ 
appropriate security measures to minimize the possibility of 
unauthorized persons uploading, editing or otherwise tampering with 
web-distributed labeling information. For example, the system could 
maintain password-protected access and an audit history for persons 
performing any activity other than accessing labeling. Appropriate 
functionality would allow the Web site to meet the needs of users by 
delivering streamlined labeling and to ensure the integrity of the 
labeling through necessary security measures.
    ii. Desirable Components of the Web site(s). In contrast to the 
necessary functionality listed above, the following components are 
desirable in a web-distributed labeling system to facilitate a more 
positive user experience. The desirable components of a Web site are 
providing single URL (Web site address) to access the web-distributed 
labeling system, providing a static URL for each product, allowing 
users to select the format for the labeling, highlighting changes 
between current and historical versions of labeling, and providing 
links to training and other tools for applicators.
    A single uniform resource locator (URL) (e.g. https://www.webdistributedlabeling.com) as opposed to multiple URLs (e.g., 
https://www.webdistributedlabeling.com, https://www.webdistributedlabeling22.com, etc. Note: These Web sites are 
fictional and will not provide legally enforceable pesticide product 
labeling.) would allow users to visit a single Web site to search for 
and download all labeling. While the container label will identify the 
Web site for each product, having a single Web site address on all 
products participating in the web-distributed labeling system should 
make education and training of users easier and more effective.
    Static web addresses for web-distributed labeling would always link 
to the current labeling for Product X, for example https://www.webdistributedlabeling.com/ProductX_current.htm. This would allow 
users to ensure that they are always linking to the current version of 
the labeling without having to search through the Web site.
    A feature that allows users to specify the format of the labeling, 
e.g., PDF, html, mobile version, would provide users with flexibility 
to download or view the labeling in the format most convenient and 
accessible to them.
    A feature that highlights changes made in the most recent version 
of web-distributed labeling by comparing the most recent version with a 
historic version of web-distributed labeling would assist users in 
quickly determining what components of the labeling had changed.
    Finally, the web-distributed labeling Web site could also be used 
to house or link to materials that may be helpful to pesticide 
applicators or other users, such as training materials, rate 
calculators, supplementary health and safety information, equipment 
calibration instructions, stewardship information, versions of labeling 
in different languages, and many other types of information.
    EPA considered an optional feature of providing the EPA-approved 
master labeling, but decided that it would not be a good fit in the 
web-distributed labeling system. An electronic version of the master 
labeling can currently be found in the Pesticide Product Labeling 
System (PPLS). Since the intent of web-distributed labeling is to 
provide state-approved labeling to the user and master labeling is 
already available electronically, the Agency decided against adding 
this as a desirable component of a potential web-distributed labeling 
Web site.
    iii. Web site Hosting Approaches. Although the specifics of the 
technological architecture used to implement the WDL should be left up 
to those involved in the actual development, EPA considered some basic 
concepts of web site and database design, including who should host, or 
be responsible for hosting, the WDL Web site(s). This section discusses 
options for the Web site portal and databases, and potential hosts and 
the advantages and disadvantages associated with each. A discussion 
paper on web-distributed labeling Web site hosting is available at 
https://www.epa.gov/pesticides/regulating/registering/index.htm.
    There are two critical components in the architecture of the web-
distributed labeling system:
    (1) The portal, i.e., the initial Web site visited by users or the 
public to begin their search for web-distributed labeling, and
    (2) The database(s) holding the files necessary to generate web-
distributed labeling. EPA believes that a single Web site portal 
connected to multiple databases maintained by pesticide companies would 
be the most appropriate option for a web-distributed labeling system.
    A single Web site would provide users with one access point for all 
information related to web-distributed labeling. The Web site would 
contain software necessary to allow users to specify search criteria 
(i.e., registration number, state, and use site) and for the Web site 
to identify and interact with separate databases containing the 
information necessary to generate appropriate web-distributed labeling. 
This alternative would operate in a manner similar to a service such as 
the online bookseller, Amazon. All users visit the Amazon.com Web site 
to search for their products, and the Amazon Web site, in turn, 
searches multiple databases (of its warehouses and partner dealers) to 
provide the requested information back to the user. For the WDL system, 
a single pesticide labeling portal would be linked to databases 
maintained by registrant and/or third parties. Multiple databases would 
allow multiple entities to share the responsibility for maintaining and 
updating databases. Such a system would require the use of consistent 
standards for data-formatting and searching to be effective.
    One alternative is that all WDL information would be maintained in 
a single database. This approach would assure a standard delivery 
format for

[[Page 82019]]

labeling, and the single access point would be easier for users to 
remember. A single database would assist federal and state enforcement 
personnel in reviewing the labeling. However, a single portal and 
database could require a single entity to process and maintain a large 
amount of information.
    A second alternative is multiple Web site portals with multiple 
databases, which would require the user to visit a specific site for 
each product. It would be similar to the multiple options available to 
purchase a car online. A user can visit each dealer's Web site but 
cannot search all databases at once for information on a car; each 
database must be searched separately for different car models. This 
approach would allow each entity to maintain data in its own format, 
but would impose additional burden on users to visit a different Web 
site for each product they intend to use. Extra burden could lead to 
non-compliance. It would also be more burdensome for enforcement 
personnel who would have to search each Web site/database individually.
    iv. Potential Web site Portal and Database Hosts. Whether the 
approach chosen is a single Web site and database, a single Web site 
linked to multiple databases, or multiple Web sites with multiple 
databases, the options for hosts of the web-distributed labeling Web 
site portal(s) and database(s) are the same. EPA, registrants, and 
third-party vendors could operate the Web site(s) and database(s). 
While there are positives and negatives associated with each, if the 
preferred single portal, multiple databases approach is chosen, then 
the most likely hosts of the Web site would be EPA or a third-party 
vendor and the hosts of the databases would be registrants and third-
party vendors.
    Regardless of which entity hosts the Web site, registrants would be 
responsible for posting the marketed product labeling approved by the 
state. Registrants would have the flexibility to post each product's 
labeling as it is approved by the state. States would be able to 
continue to use their current process for reviewing and approving 
pesticide labeling, whether it is done electronically or on paper. 
States would not be responsible for posting labeling but would have 
full access to the system in order to verify that the labeling posted 
is accurate and matches the state-approved version.
    EPA: As the Federal authority for pesticide registration and 
regulation, EPA is involved in the registration of almost all 
pesticides. It maintains historical records of all master labels 
submitted and approved, and it is developing a structured database for 
all master labeling content (E-label program). If EPA were to host the 
Web site for web-distributed labeling, EPA would likely operate a 
single portal Web site and would likely rely on other entities (e.g., 
registrants or states) to provide the electronic files on state-
approved marketed product labeling that would be accessed by and 
through the Web site.
    Potential disadvantages to EPA's serving as the host are that EPA 
may be unable or less likely than a third-party vendor to link to other 
commercial Web sites, limiting the potential benefit of web-distributed 
labeling to provide links to training and tools to users. Also, with 
EPA as host, determining who is liable for errors with the labeling 
could be more difficult.
    Although EPA does maintain master labeling for all pesticide 
products, users rely on the state-approved marketed product labeling to 
make applications. EPA is not involved in the state approval process 
for marketed product labeling and does not require states or 
registrants to submit the approved marketed product labeling to the 
Agency. Making EPA the host of the web-distributed labeling Web site 
would increase burden on registrants to submit the final state approved 
labeling to EPA for posting.
    Registrants: Registrants are ultimately responsible for obtaining 
approval for and distributing pesticide labeling. Registrants submit 
their applications for registration to EPA and, after receiving 
approval, use the master label to get state approval for marketed 
product labeling and updates. Because registrants track the labeling at 
each step of the approval process, they are in best position to ensure 
that the labeling provided to the web-distributed Web site(s) is the 
latest approved version. In addition, most registrants already have and 
maintain Web sites for their products and could use them as the basis 
for a web-distributed labeling.
    Third-Party Vendor: Third-party vendors could include for-profit 
and not-for-profit organizations. Some already provide a service to 
registrants and states facilitating electronic submission of labeling 
or to the public by harvesting available pesticide registration data 
and making it available online. Some third-party vendors charge a 
subscription fee.
    Third parties could offer comprehensive services to create 
electronic files for labeling and submitting them for approval by the 
state, or could rely on other entities (e.g., registrants or states) to 
provide the electronic files on state-approved marketed product 
labeling that would be accessed by and through the Web site(s).
    A registrant or third-party would likely be able to quickly adopt 
new technology with fewer constraints than apply to the federal 
government and might be able, therefore, to revise the Web site to 
improve the user experience.