[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82011-82025]
From the Federal Register Online via the Government Publishing 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: http://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
http://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 http://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 http://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: [email protected].
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 http://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: http://epa.gov/pesticides/ppdc/distr-labeling/index.html.
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 http://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 http://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: http://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 http://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. http://www.webdistributedlabeling.com) as opposed to multiple URLs (e.g.,
http://www.webdistributedlabeling.com, http://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 http://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
http://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. However, adding another actor to the
pesticide labeling process introduces the potential for additional
errors. Overall, third-parties are more flexible and attuned to the
needs of their customers, whether they are users, registrants, or
government.
States: EPA initially considered suggesting states as a potential
host for a web-distributed labeling system. State lead agencies provide
the final approval for a product's labeling before it is released into
the channels of trade. However, because states have independent
processes for reviewing and approving labeling and may not have the
capacity to build a Web site for labeling, EPA decided not to consider
states as a potential host for a web-distributed labeling Web site.
EPA seeks comments on the following:
Do the critical components of the web-distributed labeling
Web site provide sufficient functionality for users and other
stakeholders? Should any optional components be considered critical
components?
Are there other non-critical features of the Web site that
EPA has not considered? Please describe their purpose and utility.
Which Web site hosting approach does your organization
support? Why?
Are any proposed Web site hosting approaches not possible
or practical? Why?
Which potential Web site host is preferable? Why?
Are there other potential benefits or drawbacks associated
with having any of the entities listed above host the web-distributed
labeling Web site?
6. Alternative Delivery Mechanism for Labeling. Alternate
mechanisms of delivery must be developed to provide pesticide labeling
to those users who do not have access to the web and/or the necessary
technology to download and print WDL labeling. Alternatives for those
without adequate access to the Internet include the alternative
delivery mechanisms of faxing and U.S. Mail, alternate electronic
mechanisms such as mobile technology, and accessing labeling from
alternate locations that may have Internet access, such as the place of
purchase, libraries, schools, and county extension offices.
[[Page 82020]]
The primary alternate delivery mechanisms the Agency expects to be
used are fax on demand and U.S. Mail. Both the faxing and mailing
options could be developed in conjunction with a toll-free hotline
through which pesticide users could request the necessary labeling. The
user would call the toll-free number, provide the state(s) and site(s)
of intended use, and request the streamlined labeling via mail or fax.
Users would also have the option to request the full product labeling.
It is expected that the toll-free hotline number would need the
following characteristics or functions to ensure faxing and sending
labels via mail are viable alternatives: Nearly 24-hour access; no
charge to callers; multilingual capability; non-automation; ability to
fax and send via mail; and ability to quickly respond to user requests.
Once the user requests the labeling through the hotline, it needs
to be delivered to the user. Faxing the labeling is an option for users
who have access to a fax machine. This mechanism seems most feasible
for users that apply pesticides in the course of their work, such as
commercial pesticide applicators, because this group is more likely to
own fax machines. A mechanism accessible by all pesticide users is the
U.S. mail. Standard delivery through U.S. Mail should not have any
extra costs to the user but expedited delivery could be offered for an
additional charge. First class mail takes about 1 to 3 days to get to
the recipient, which is in addition to any processing time needed to
select, print, and prepare the labeling to be mailed. This processing
time needs to be minimized in order to keep this mechanism feasible.
Mobile technology is another possible alternative delivery
mechanism because cell phones and other mobile devices may be more
accessible for users that do not have access to computers and/or the
Internet. However, mobile technology may be limited due to limited
network coverage, the size of files that can be downloaded, and slower
access speeds. Another issue with mobile technology is that some states
may require the users to have a paper copy of the label and it isn't
clear if labeling can be printed from these devices. For users in
states that do not require the user to have a paper copy of the
labeling, delivery of labeling to a smart phone is a feasible
alternative to accessing and printing the labeling at a traditional
computer.
Some places, such as the place of purchase, libraries, schools, and
university extension service offices, may serve as alternate locations
to access the Internet and/or fax machines, and thus access web
distributed labeling. Access may be limited in some of these locations
(e.g., libraries may have slow Internet connection speeds and limited
availability of computers and printing, schools may not be accessible
to non-students). While EPA recognizes that these locations could be a
potential place for users to access web-distributed labeling, the
Agency will not rely on the place of purchase, libraries, schools, or
university extension services as the primary alternate delivery
mechanism for web-distributed labeling.
EPA believes that all of these mechanisms should be explored. At a
minimum, faxing and mailing should be implemented as the primary
alternate delivery mechanisms for web-distributed labeling, and
outreach should be done to ensure that alternate locations are an
option for at least some users.
EPA requests stakeholder input on the proposed alternate delivery
mechanisms. Please respond to the following:
Who should administer the alternate delivery mechanisms
(maintaining the toll-free hotline, mailing and faxing the labels)?
Who should pay for administering the toll-free hotline and
mailing the web-distributed labeling?
Are there other feasible alternate delivery mechanisms for
web-distributed labeling? Please describe them and how they could be
implemented.
7. Outreach and Culture Change. Web-distributed labeling would be a
potentially major change for pesticide users. Although many may be
familiar with using the Internet, they have not relied on it for
pesticide labeling. Users would have to adapt to a new way of obtaining
product labeling but regardless of the distribution system employed,
their responsibility to obtain and follow all label and labeling
instructions would not change. To avoid the increased risk to public
health and the environment created if users do not obtain and follow
the labeling as required, it would be essential to develop and
implement a comprehensive communication plan about web-distributed
labeling to educate users and those who conduct training or make
pesticide use recommendations.
Outreach regarding the new labeling access method and the required
culture changes will need to be multifaceted with different
communication messages, timing, and collaborations depending on the
stakeholders and target outreach audience. Although it may be necessary
to tailor the information to specific audiences, locations and products
for the pilot, the underlying issues are the same. A more complete
discussion of outreach and communication is available at: http://epa.gov/pesticides/ppdc/distr-labeling/jan09/ed-culture.pdf.
Two facets of a successful outreach campaign are a clear,
consistent message delivered repeatedly to the user and involving all
relevant stakeholders in the outreach effort. The three messages would
be:
(1) Web-distributed labeling will replace paper-based labeling on
only some products (but not all products) and only in some marketplaces
(not home and garden or antimicrobials);
(2) Users still must follow federal and state requirements,
including, where applicable, possession of the labeling at the time of
application, and comply with all labeling use restrictions and
instructions (whether attached, accompanying, or web-distributed
labeling); and
(3) There are different ways to obtain web-based labeling: Internet
download and the alternate delivery mechanisms, such as fax or mail.
A number of pathways exist that provide information to
stakeholders: EPA, registrants, cooperative extension service, state
regulatory and enforcement agencies, trade associations, user groups,
pesticide dealers and crop advisors, and farm worker advocacy groups.
With an understanding of the benefits of a web-distributed labeling
system, they would be better equipped to pass the information to the
end user. Before implementing any web-distributed labeling program, EPA
would work with the stakeholder groups identified above as well as any
other interested parties to develop a comprehensive plan for outreach.
EPA plans to work with representatives from the groups listed above
in developing a strategy to conduct collaborative outreach in order to
ensure that culture change regarding web-distributed labeling occurs in
the most effective manner possible. EPA would also work through
existing committees, networks, and workgroups, including the Pesticide
Program Dialogue Committee, the NAFTA label workgroup, the State-FIFRA
Issues Research and Evaluation Group (SFIREG), The Pesticide
Stewardship Alliance (TPSA), and the Association of American Pesticide
Control Officials (AAPCO). The American Association of Pesticide Safety
Educators (AAPSE) will be a critical partner because of its experience
in developing educational material and its knowledge of how to
[[Page 82021]]
conduct effective outreach into the pesticide user community. The
message will be delivered most effectively if responsibility for doing
so is shared, because each individual organization has its own
expertise, experience and reach into the user community.
Education of users would begin well before implementing a web-
distributed labeling system. Those delivering the web-distributed
labeling message to users should have an understanding of it and their
role as educators and information sources at least 6 months before the
pilot begins. EPA recognizes the timing of training will dictate the
most effective times to conduct outreach and would plan the initiation
of the outreach and education component of web-distributed labeling
with this timeframe in mind.
EPA requests comment on the proposed approach to stakeholder
outreach and education.
Are there audiences or partners that have not been
identified?
Are there alternate ways to deliver the message more
efficiently or effectively?
8. Enforcement. Under the current system, a user is required to
comply with the pesticide product labeling. The requirement for
applicators to comply with labeling will not change under web-
distributed labeling; as under the existing paper-based system, an
applicator's failure to follow the use directions or other labeling
language would be a violation of FIFRA Sec. 12(a)(2)(G).
Pesticide labeling is enforced under FIFRA Sec. 12 which lists
various unlawful activities. FIFRA Sec. 12(a)(1)(A) declares it
unlawful to sell or distribute a pesticide not registered under FIFRA
Sec. 3. FIFRA Sec. 12(a)(1)(B) declares it unlawful for any person to
distribute or sell a product whose claims differ from those made in
connection with its registration. FIFRA Sec. 12(a)(1)(E) declares it
unlawful for any person to distribute or sell a misbranded product as
defined in Sec. 2(q). FIFRA Sec. 12(a)(2)(A) declares it unlawful for
any person to detach, alter, deface, or destroy, in whole or in part,
any labeling required under the Act. FIFRA Sec. 12(a)(2)(G) declares
it unlawful for any person to use any registered pesticide in a manner
inconsistent with its labeling. FIFRA Sec. 12(a)(2)(H) declares it
unlawful for any person to use any pesticide which is under an
experimental use permit contrary to the provisions of such permit.
FIFRA Sec. Sec. 13 and 14 describe the actions the Agency may take in
response to violations of the Act.
Web-distributed labeling would mean a change in the way labeling is
delivered, but not in the way it is enforced. Enforcement of FIFRA and
EPA's regulations is necessary to ensure that pesticides continue to be
used according to labeling requirements. This section explores how
implementation of a WDL system would affect the legal responsibilities
of users and registrants, users, and distributors to comply with FIFRA.
Further discussion is available at: http://epa.gov/pesticides/ppdc/distr-labeling/june09/enforcement-paper.pdf.
i. Registrants. States have primary enforcement authority for
pesticide use violations. EPA generally pursues violations of the
FIFRA's labeling requirements. Compliance monitoring would be a joint
federal-state effort to monitor labels in the marketplace and ensure
that applicators are using and following current and appropriate labels
when applying pesticides. This approach would not be altered by a web-
distributed labeling system.
Registrants are ultimately responsible for ensuring that the label
affixed to or accompanying a product when it is released into channels
of trade is current and accurate. Although the registrant may enter
into contracts with other parties acting as the registrant's agent to
produce or label products, the registrant is still ultimately
responsible for the labeling of the product. Under a web-distributed
labeling scenario, the registrant would be responsible for ensuring
that current and accurate labeling is available for users to obtain. By
listing a Web site address on the label, the registrant would take
responsibility for the content of the Web site concerning that product.
There are a number of alternative methods that have been proposed for
distribution of labeling, including fax-on-demand services or toll-free
telephone lines to request a copy of the label. Regardless of how the
user obtains the label, the registrant would be responsible for the
labeling content delivered to the user.
The registrant would be responsible for providing a legally valid
label to the user. There may be instances where a registrant contracts
with a third party to provide labeling to users under a web-distributed
labeling system. Transferring this duty from the registrant to the
third party Web site host does not absolve the registrant of its
ultimate responsibility. The Agency may also find the registrant liable
for violations of FIFRA regarding the Web site's operations and
content. FIFRA Sec. 14(b)(4) provides that the act, omission, or
failure of any officer, agent, or other person (e.g., a Web site host)
acting for or employed by any person regulated by FIFRA (e.g., a
registrant) shall be deemed to be the act, omission, or failure of such
person (a registrant) as well as that of the person employed (the
host). The Agency is considering whether registrants seeking to use
web-distributed labeling for their products should be required to
submit, as part of the pesticide's registration under FIFRA,
documentation of their contractual arrangements with Web site
operators. Such a requirement would serve many purposes including the
following:
(1) it will encourage registrants to enter into contractual
agreements with reputable Web site operators; and
(2) it will expedite federal and state compliance monitoring
efforts.
ii. Users. Pesticide users are responsible for applying the product
in accordance with the restrictions and directions in pesticide product
labeling. The provisions of a product's labeling are generally
enforceable, and violations of a product's labeling are punishable by
civil or criminal penalties under FIFRA Sec. 14. A user's
responsibility to follow labeling instructions, and the consequences of
not doing so, would not change under web-distributed labeling.
Under web-distributed labeling, the container's label will require
the user to possess the labeling referenced on the pesticide container
(i.e., directions for use) prior to mixing, loading, or applying the
pesticide. Failure to possess the directions for use as required by the
container's label will constitute misuse of the pesticide product and
violate FIFRA Sec. 12(a)(2)(G). There is an issue with respect to what
actions by a user would constitute having an appropriate copy of the
labeling in his possession. EPA would regard having either a paper copy
of the downloaded labeling or an electronic file as meeting the
requirement to have a copy of the labeling but state requirements may
be different. Further, if the user had multiple containers of the same
product, he would need to have only one copy (paper or electronic) of
the labeling for that product. State laws may differ and may require
hard copies.
The container's label will also require the user to follow the web-
distributed labeling. Failure to follow the use directions or other
requirements contained in the web-distributed labeling violates FIFRA
Sec. 12(a)(2)(G). FIFRA is a strict liability statute. Thus, if the
user obtains an incorrect version of the labeling and applies the
pesticide consistent with the incorrect directions, it may be a
violation of FIFRA Sec. 12(a)(2)(G) because the application was not
made consistent with the approved labeling. The user may be able to
argue as an affirmative defense the correctness and accuracy of the
downloaded labeling or that they
[[Page 82022]]
followed the correct process to retrieve the correct labeling but
nonetheless received the incorrect labeling.
A user could not use the unavailability of a Web site as a reason
for not obtaining a copy of the web-distributed labeling because the
container label will provide at least one alternative method of
obtaining a copy of the labeling. EPA would expect the user to employ
the alternative method in case the Web site was not available before
mixing, loading or applying the pesticide.
iii. Pesticide Dealers & Other Distributors. Currently, dealers and
other distributors of pesticides are also responsible for ensuring that
the registered pesticides they sell or distribute have their complete
labeling. If the labeling is incomplete the pesticide may be
misbranded, and it is a violation of FIFRA Sec. 12(a)(1)(E) to sell or
distribute a misbranded pesticide. However, Congress intended to allow
any person who violates FIFRA Sec. 12(a)(1)(E) to shift his or her
liability to the registrant from whom the person purchased or received
the pesticide if that person holds a ``guaranty'' in writing from the
registrant. FIFRA Sec. 12(b)(1). A guaranty is a written agreement
between the dealer or distributor and the registrant or other person
who sells the pesticide to the dealer or distributor, and notes that
the pesticide was lawfully registered at the time of the sale and that
it complies with all requirements of FIFRA. The guaranty transfers
liability for any violations associated with labeling or misbranding
from the dealer or distributor to the registrant or other person who
provided the pesticide. The FIFRA guaranty provision would not be
affected by web-distributed labeling.
Dealers and distributors may elect under the current system to
provide parts of EPA-approved labeling for a product to their customers
when they sell or distribute a registered pesticide. Such accompanying
material must travel with the pesticide product from a registered
establishment where the product was produced. 40 CFR 167.3 defines
``produce,'' in part, as ``to package, repackage, label, relabel or
otherwise change the container of the any pesticide or device.''
Further, 40 CFR 167.20 requires establishments where pesticidal
products are produced to be registered with EPA. Since the container
would bear an affixed label when dealers and distributors receive it,
they would not be relabeling the product; therefore, they would not be
considered producers and not required to register as establishments.
Under web-distributed labeling, there would be no requirement for
dealers and distributors to register as establishments that ``produce''
pesticidal products because the web-distributed labeling is tied to the
product by reference, and thus part of the labeling. As long as the
dealer or other distributor provides the purchaser with all of the
labeling required to accompany the pesticide container, the dealer or
other distributor of the pesticide would not be in violation of FIFRA.
Dealers may, as a service to their customers, provide the means for a
user to obtain labeling through an Internet connection whereby the
customer can download the labeling for the product he just purchased.
Offering this service does not make the dealer liable for the failure
of the user to obtain the proper labeling, nor does providing the means
for obtaining labeling make the dealer's facility a production facility
and subject to establishment registration. In sum, dealers would need
to meet the same state and federal requirements for selling pesticides
to which they are now subject.
Under current law dealers and other distributors of pesticides may
elect to provide parts of the EPA-approved labeling for a product to
their customers when they sell or distribute a registered pesticide.
Such accompanying material must travel with the pesticide product from
a registered establishment where the product was produced.
EPA seeks comments from stakeholders on the potential enforcement
of web-distributed labeling, specifically on:
Would states be able to enforce web-distributed labeling
under their current laws and regulations?
Are there potential areas of enforcement that the Agency
has not considered?
Do users, states, registrants, or other stakeholders think
that enforcement would be significantly different under web-distributed
labeling? If so, please provide an explanation of how.
V. Issues
A. User Access
It is necessary to ensure that all users can access web-distributed
labeling in order to assure that they have the information needed to
use pesticides safely and effectively. EPA would not implement web-
distributed labeling if users were unable to access labeling and as a
result did not comply with labeling directions during application.
While broadband penetration is expanding across the United States,
especially in rural communities, not all users have internet access or
the ability to download and print large files. A 2009 survey conducted
by the United States Department of Agriculture found that 59 percent of
farms in the United States had internet access. Internet access varies
by geographic location and farm size. See http://usda.mannlib.cornell.edu/usda/current/FarmComp/FarmComp-08-14-2009.pdf.
To ensure that all pesticide users are able to access the labeling, EPA
will make labeling available either electronically or through an
alternate delivery mechanism. However, EPA expects that as broadband
penetration increases, users' reliance on the alternate delivery
mechanism for web-distributed labeling would decrease.
EPA will continue to monitor internet and computer access in rural
communities. To ensure that no system is implemented that would
compromise access to and thus compliance with labeling, EPA plans to
conduct several pilots related to web-distributed labeling (see Unit
VI.). The pilots will evaluate users' potential to access the internet
to download web-distributed labeling and the feasibility of alternate
delivery mechanisms.
EPA requests comments on the following:
Are there other ways to reach pesticide users that do not
have internet access other than those considered by EPA?
What types of outreach should EPA and other stakeholders
do to ensure that all pesticide users understand and could use web-
distributed labeling, regardless of internet access?
B. User Acceptance/Outreach
Product labeling is the primary mechanism used by EPA to
communicate critical information to the pesticide user. The labeling
contains use directions, health and safety information, and
instructions for proper disposal, as well as other important
information. Both FIFRA and pesticide labeling regulations assume that
users follow the use directions on the label and labeling for
registered products; users that do not comply with labeling are subject
to penalties for non-compliance. To protect human health and the
environment from the risks associated with pesticide misuse or
misapplication, it is of the utmost importance that pesticide users
follow labeling instructions.
Implementation of web-distributed labeling would have to ensure
that risks to the public and the environment are not increased by
users' failure to download and follow the pesticide labeling. EPA would
not move forward
[[Page 82023]]
with web-distributed labeling if EPA were to conclude that the system
is unlikely to enhance users' understanding and following of pesticide
labeling. To gauge user acceptance and to ensure that the web-
distributed system is designed to be as user-friendly and functional as
possible, the Agency is developing a pilot as described in Unit VI.
EPA requests comments on the following:
Is there data on professional pesticide users' reading and
understanding of the label under the current paper-based system?
In addition to doing a pilot to gauge user acceptance of
the concept of web-distributed labeling and potentially doing a field-
level pilot, what else could EPA do to measure users' acceptance of the
concept and likelihood of downloading the labeling from a Web site?
C. State Acceptance
As discussed in Unit II.A.2., state registration of pesticide
products varies widely. Since users are required to comply with the
marketed labeling registered by states, it is essential that states are
actively involved in the development of a web-distributed labeling
system. To move forward with web-distributed labeling, EPA will need
the support of all states. EPA has been working with both state lead
agencies for pesticide regulation and cooperative extension services to
get feedback from these stakeholders. The primary concerns of states
are ensuring the enforceability of web-distributed labeling and not
being required to significantly alter their registration systems.
A web-distributed labeling system would not require every state to
adopt the same registration system. States could continue to use their
existing registration systems, receiving the marketed labeling either
electronically or as a hard copy from registrants. EPA anticipates that
registrants would be responsible for entering the approved marketed
labeling into the database(s) for the web-distributed labeling system,
meaning no increased burden for review and approval of products in a
state.
EPA also recognizes that coordination with states and registrants
would be necessary to implement web-distributed labeling. If a company
chooses to participate in web-distributed labeling, both the state and
the registrant would need to understand the process and the format of
the approved labeling. States would need to notify registrants how the
approval process would work to ensure that the labeling posted to and
retrieved from the web-distributed labeling system would be valid.
The Agency will continue to work with states through the
Association of American Pesticide Control Officials (AAPCO) and the
State-FIFRA Issues Research and Evaluation Group (SFIREG) to ensure
their concerns are addressed in the development and implementation of
web-distributed labeling.
EPA seeks comments on the following:
What are specific areas in which web-distributed labeling
could affect state programs?
What would be the impact of web-distributed labeling on
state programs?
How could EPA satisfactorily address concerns about the
effect of web-distributed labeling on state programs?
D. Registrant Liability
In the PPDC Workgroup on web-distributed labeling, a number of
stakeholders voiced a concern that implementing a system of web-based
distribution of pesticide labeling could change the potential tort
liability of registrants. ``Tort liability'' refers broadly to the body
of law for establishing rights and remedies in non-criminal lawsuits to
provide relief for persons who have suffered injury because of the
wrongful acts of others. This area of the law addresses a wide variety
of ``civil wrongs'' (referred to as ``torts''), not arising out of
contractual obligations. Although the legal principles governing tort
liability are quite extensive and sometimes complex, the basic
framework is fairly simple. If one person has been harmed by the
behavior of another, the injured party may bring a lawsuit against the
person who allegedly caused the injury in order to recover damages. If
a judge or jury finds that the defendant's behavior caused the damage
and that the behavior was ``negligent,'' i.e., did not meet the
relevant standard of care, the defendant normally could be found liable
for damages caused. Negligence can occur in many different situations
and can involve many different types of behavior. Whether a particular
person's behavior constitutes ``negligence'' typically is determined on
a case-by-case basis. When dealing with the sale of products,
negligence claims can involve making a defective product (one that does
not work as claimed), or failing to provide adequate instructions or
warnings so that the user can use the product without injury.
The Agency asked participants in the PPDC Workgroup to explore the
impact on registrants' potential tort liability of a web-based system
of distributing labeling. In response several work group members
collaborated on the preparation of an issue paper, ``Liability Concerns
Associated with Web-Distributed Labeling,'' which is available at:
http://www.epa.gov/pesticides/ppdc/distr-labeling/sept09/liabilityissues.pdf. In addition to tort liability, the PPDC issue
paper discusses a number of other topics. One was registrants',
dealers', and users' liability for violations of FIFRA and associated
state regulatory requirements. Unit III.C.8. deals with enforcement of
FIFRA requirements, and addresses the aspects of the paper dealing with
liability for regulatory violations.
The PPDC paper also identified unsettled legal issues concerning
the scope of state authority to regulate pesticides, in particular
whether a state has the authority to refuse to approve or register a
product, therefore effectively prohibiting its sale, if the State did
not consider the EPA-approved pesticide labeling adequate. Whatever the
merits of the competing views of the legal issue might be, EPA believes
that a decision to allow a registrant to use a web-distributed labeling
system would not affect the scope of states' authority to regulate
pesticides within their borders. States would have no greater or less
authority to refuse to approve a pesticide using web-distributed
labeling than they have to refuse to register pesticides under the
current system. (EPA takes no position in this notice on the extent of
State authority to refuse to register a pesticide and what reasons, if
any, would be legally sufficient.)
Finally, with respect to tort liability, the PPDC paper raised
several questions but did not suggest possible answers. The PPDC paper
did not contain sufficient explanation for EPA to understand the basis
for concern that a voluntary, web-distributed labeling approach might
increase the risk of successful tort liability lawsuits against
registrants, much less what steps EPA or others might take to minimize
any such risk. Consequently, EPA asked the authors to revise and expand
the paper using examples to illustrate how a web-distributed labeling,
approved by EPA, could affect registrants' potential tort liability.
EPA has not received a new version of the issue paper.
Because the legal authority, registration processes, and
requirements for users to follow all pesticide labeling are the same
under web-distributed labeling as they are under the current system,
EPA does not believe that web-distributed labeling will introduce
additional tort liability to pesticide manufacturers or distributors.
[[Page 82024]]
EPA requests comments on the following:
Would a decision to adopt a system of web-based
distribution of pesticide labeling affect the potential tort liability
of registrants? As part of the comment, please describe the legal
theory for potential negligence and how web-distributed labeling
affects the likelihood of successful tort claims against a registrant,
especially as compared with the current paper-based system of
distributing labeling.
What steps might EPA take to evaluate whether the extent
of compliance with pesticide labeling increases, decreases, or does not
change when comparing pesticide users who buy products using web-
distributed labeling vs. users of products following the current
system?
To what extent could a system of web-distributed labeling
affect the authority of a state to regulate pesticides?
VI. Next Steps
This section presents EPA's thoughts on the next steps for
exploring the concept of web-distributed labeling. In addition to
continuing its outreach efforts with stakeholders and considering
feedback on this Federal Register Notice, EPA intends to conduct a User
Acceptance Pilot. Based on the feedback gathered during the User
Acceptance Pilot and from this notice, a Virtual Pilot and Limited
Field Pilot may be developed.
A. Customer Acceptance Pilot
The User Acceptance Pilot would simulate the web-distributed
labeling experience using a real Web site, which would be capable of
providing web-distributed labeling for a limited number of pesticide
products. The labeling downloaded from this Web site would not be valid
for purposes of authorizing a user to apply the products involved. The
users would go through the following steps:
1. Log onto an Internet-accessible Web site.
2. Enter a product registration number or other product identifier
for one of several pre-determined products.
3. Select the relevant state/county in which the mock pesticide
application would take place.
4. Select the relevant use pattern(s) for the mock pesticide
application to filter the labeling according to use pattern(s).
5. View and download from the Web site the labeling appropriate for
the identified product, use pattern, and state provided.
In addition, the pilot Web sites would:
1. Place a prominent statement on each page of the downloaded
labeling making it clear that the labeling downloaded from the Web
site(s) was not legally valid for purposes of making a pesticide
application.
2. Offer users a mechanism for providing feedback on the web-
distributed labeling experience.
The purpose of the User Acceptance Pilot is to research the extent
to which users would accept a system requiring them to obtain labeling
via the Internet. The specific goal of the pilot is to determine
whether the benefits of web-distributed labeling would be sufficiently
appealing to users that they would be willing to visit a Web site to
obtain labeling for a pesticide product. The pilot would demonstrate
how users could access labeling information using the Web site and
would not involve the actual distribution to users of actual pesticide
product labeling that would rely on the web-distributed labeling
approach.
The results of this research are important for EPA in deciding
whether and how to move ahead with further efforts to develop such a
system. Consequently, the Agency not only expects participants in the
Pilot to offer users a mechanism for providing feedback on the web-
distributed labeling experience, but also encourages participants to
summarize and submit to EPA the feedback obtained through the pilot.
EPA hopes to receive information on users' opinions about paper labels,
the web-distributed labeling Web site experience, web-distributed
labeling overall, and other potential features of web-distributed
labeling.
More information on the User Acceptance Pilot is available at
http://www.gpo.gov/fdsys/pkg/FR-2010-08-18/pdf/2010-20449.pdf.
B. Review of Public Comments on Federal Register Notice
EPA is using this notice to solicit comments and suggestions from
stakeholders and the public on the concept of web-distributed labeling.
EPA will review comments as they are submitted and will present the
information received to interested parties. EPA plans to incorporate
feedback received through this notice into the development of the
planned pilots and in refining the concept of web-distributed labeling.
EPA intends to continue communicating with WDL stakeholders to
provide updates and gather feedback as it moves closer to implementing
WDL. In addition to addressing comments received in response to this
and other WDL Federal Register Notices, EPA will continue to provide
updates on the EPA Web site, meet with and encourage the submission of
information from stakeholders, and gather and respond to informal
comments received on the User Acceptance Pilot and Virtual Pilot
described above.
C. Virtual Pilot
The Virtual Pilot would demonstrate the actual functionality of
web-distributed labeling through the creation of an actual Web site and
supporting database(s). The goals of the pilot would be to assess
whether the Web site works properly for registrants, EPA, states, and
users. The objectives, scope, assumptions, and program assessment are
discussed in a paper at http://epa.gov/pesticides/ppdc/distr-labeling/sept09/wdl-virtualpilot.pdf. This pilot could be conducted in
conjunction with the Limited Field Pilot discussed in Section D below.
D. Limited Field Pilot
The Limited Field Pilot would implement web-distributed labeling on
a trial basis, in a limited geographical area and with a small number
of products. The Limited Field Pilot would be informed by the findings
of the Customer Acceptance Pilot and comments on this Federal Register
Notice. Users in areas participating in the Limited Field Pilot would
only be able to obtain the full labeling for a participating product
using web-distributed labeling. Containers would bear a limited set of
the labeling (see Unit III.C.3). Since the Limited Field Pilot depends
heavily on the feedback received from stakeholders, the concept will
not be developed substantially until the other pilots have been
completed.
VII. Conclusion
After extensive stakeholder feedback and refinement of the concept,
EPA believes that web-distributed labeling would be beneficial to
users, registrants, states, other stakeholders and the Agency.
Stakeholders would benefit from faster implementation of risk
mitigation and new uses, faster access to new uses, reduced printing
costs, and streamlined labeling. Since labeling is the critical
component that allows EPA to communicate use and safety instructions to
users, an initiative to make the labeling streamlined, and easier to
read and understand could lead to increased compliance and therefore
improved protection of human health and the environment. EPA recognizes
that issues exist with implementation of a web-distributed labeling
system. However, given the
[[Page 82025]]
potential benefits, EPA plans to move forward to pilot some of these
concepts and to address outstanding questions. The Agency will continue
to engage all stakeholders in the consideration of this ambitious
system.
List of Subjects
Environmental protection, electronic pesticide labeling, pesticide
distribution, pesticide labeling, pesticide production, pesticide
regulation, pesticide user, state pesticide regulation.
Dated: December 13, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2010-32036 Filed 12-28-10; 8:45 am]
BILLING CODE 6560-50-P