### Web-Distributed Labeling Work group Discussion Paper
Virtual Pilot

I. Background

EPA’s Office of Pesticide Programs (OPP) is explor ing the possibility of allowing registrants to distribute some portions of pestic ide labeling via the internet. To support this effort, at the recommendation of the Pesticide Program Dialogue Committee (PPDC) subgroup for webdistributed labeling (WDL), OPP encourages the private sector to conduct a virtual pilot (hereafter “the Pilot”) of the web-distributed la beling concept. The Pilot would demonstrate how a website would be designed and how users coul d access labeling information using the website;

it would not involve the act ual distribution to users of any pesticide products that would rely on WDL approach. This issue paper presents OPP’ s current thinking on the Pilot, the associated functional specifications, and one po ssible implementation strategy.

II. WDL Virtual Pilot Overview

This section presents a description of the Pilo t, objectives, scope, assumptions, anticipated stakeholders, legal/ethical considerations, and me trics for program assessment. In general, the Pilot refers to a web-based software application that will simulate the “web-distributed labeling user experience” by allowing users to search for and download pesticide labeling.

A. Objectives

The purpose of the Pilot is two-fold: (1) to determine whether a system can be designed that registrants would use to distribute state-approved labe ling through the internet, and (2) to determine whether the benefits of WDL would be appealing enough that users would be willing to visit a we bsite to download and read labeling. To ensure the Pilot supports the purpose described above, EPA has identified the following objectives:

• Demonstrate that state-approved pes ticide labeling can be formatted (“segmented”) by use pattern in a manner suit able to be supplied to stakeholders

via the internet.

• Demonstrate that pesticide labeling can be provided accurately via the internet.

• Document the approximate cost to third pa rties for preparing a small, average, and large label for web distribution.

• Gather and evaluate stakeholder feedb ack on the usability, user understanding, and anticipated compliance for web-dist ributed labeling compared to current paper-based labeling.

• Collect stakeholder feedb ack on the look and feel of the Pilot website(s).

• Evaluate the appropriateness and comp leteness of EPA’s proposed minimum specifications for the web-distributed labeling website.

September 3, 2009 Page 1 of 7 PPDC Discussion PaperB. Scope

To increase the likelihood of achieving the objectives described above and to limit the potentially overwhelming number of variables of such an effort, th e scope of the Pilot should be limited in the following ways:

• Issues relating to users’ access to the in ternet and the web-distributed labeling website(s), connectivity speed, and website(s ) reliability are out side the scope of

this Pilot.

• Alternative delivery mechanisms (i.e., those other than the internet, such as a tollfree telephone number) are outside the scope of this Pilot.

• EPA encourages multiple participants in the Pilot.

• Each website should include, at a minimum, the labeling for at least three mock state-registered products supplied by EPA and three additional state-registered labels not supplied by EPA.

• Residential/homeowner products are out side the scope of this Pilot.

C. Assumptions

To increase the likelihood of achieving the objectives described above and to clearly communicate expectations to potential particip ants, the Pilot website(s) will be designed based on the following assumptions:

• Information submitted to or gathered w ithin the scope of the Pilot should be considered public information and sh ould not be subject to CBI claims.

• All Pilot websites should meet EPA’ s minimum functional specifications.

• Each Pilot website should be an indepe ndent application that provides a single point of access to simula te searching and retrievi ng pesticide labeling from multiple registrants.

• Any labeling supplied by the Pilot website(s) shall not be used to make pesticide applications and shall be clearly identifi ed as not being intended for actual use.

• EPA will supply three mock state-approved la bels to be used as part of each website’s labeling.

• Each Pilot website should c ontain the three mock stat e-approved labels supplied by EPA and the labeling for at least th ree more state-approved products not supplied by EPA.

• Each pilot website should in clude at least one product registered for agricultural use, one product registered for non-agri cultural use, and one product registered

for antimicrobial use.

• Although web-distributed labeling, if im plemented, may specify an expiration date, for the purposes of the Pilot, no expiration date wi ll be specified.

• Although encouraged, the webs ite(s) are not nece ssarily expected to meet the requirements specified in Section 508 of the Americans with Disabilities Act.

• EPA is not expecting to participate in the construction of the Pilot website(s).

• Tribal issues are not addressed in this Pilot.

September 3, 2009 Page 2 of 7 PPDC Discussion PaperD. Stakeholders

To improve the probability of achieving the obj ectives described above, participants in the Pilot program should solicit input and f eedback from the following stakeholders:

• People who purchase and use pesticides in the course of their business (e.g., farmers)

• People who apply pesticides for hi re (e.g., professional or commercial applicators)

• State and tribal pestic ide regulatory agencies

• Registrants/manufacturers

• Distributors/retailers/repackaging facilities

• Educators

• General public

• Public interest groups

• EPA

E. Legal and Ethical Considerations

EPA is committed to ensuring that the process for getting private sector participation is fair, equitable, ethical, and complies with a pplicable laws and regul ations including the Americans with Disabilities Act, the Paperwork Reduction Act, and the Federal Insecticide, Fungicide, and Rode nticide Act. As part of this commitment, the Agency will make every effort to engage in open dialogue with prospective/current participants and stakeholders. This dialogue will help ensure that private sector participants understand, among other things, that if EPA deci des to proceed with WDL, participation in the Pilot does not affect any future EPA decisions to award grants or contracts in

connection with further devel opment of the WDL approach.

Americans with Disabilities Act Websites operated by the federal government must comply with section 508 of the Americans with Disabilities Act (ADA). Wh ile a website operated by a private sector entity, even if users are dire cted there from an EPA website, is not required to comply with ADA sec. 508, EPA encourages such compliance.

Paperwork Reduction Act The Paperwork Reduction Act (PRA) applies to any effort by the federal government to collect information from 10 or more persons or entities by means of id entical questions. The PRA requires an agency to obtain appr oval from the Office of Management and Budget for such a collection. The PRA, how ever, does not apply to the collection of information by a p rivate party so long as the federal agency does not fund the collection-- in whole or in part--or contro l its content. Accord ingly, private sector participants in the

Pilot will decide what information to collect from stakeholders and what information to provide to EPA.

September 3, 2009 Page 3 of 7 PPDC Discussion PaperFederal Insecticide, Fung icide, and Rodenticide Act Participants in the Pilot shoul d consult the discussion paper Container-Affixed Label and Web-Distributed Labeling developed for the Pesticid e Program Dialogue Committee Web-Distributed Labeling Workgroup (h ttp://epa.gov/pestic ides/ppdc/distrlabeling/oct08/container-label.pdf) for more specific information on what is required on

the container label and what can be included only as part of web-distributed labeling.

F. Program Assessment

The purpose of the Pilot is two-fold: (1) to determine whether a system can be designed that registrants would use to distribute state-labeling through the internet, and (2) to

determine whether the benefits of WDL woul d be appealing enough that users would be willing to visit a website to download and read labeling. The following methods should be used to gauge the extent to which the P ilot was successful in answering the questions

above.

Feedback in the following areas would assi st EPA in determining whether to proceed

with WDL.

• Demonstrate that state-registered pest icide labeling can be formatted by use pattern (“segmented”) in a manner suitable to be supplied to stakeholders via the

internet.

• Demonstrate that pesticide labeling can be provided accurately via the internet.

o Conduct a quality control review for a set number of labels by comparing all portions of the approved la beling content with WDL content.

• Document the approximate cost to registrants for prepar ing a small, average, and large label for web distribution.

o Each participant should provide an estimated range for the cost of preparing a small, average, and large label.

• Gather and evaluate stakeholder feedb ack on the usability, user understanding, and anticipated compliance for web-dist ributed labeling compared to current paper-based labeling.

o All participating vendors will provide a summary of and the actual feedback received from users who accessed the system.

o EPA hopes to have a response rate greater than 20% (e.g., 2 respondents for every 10 visitors).

• Collect stakeholder feedb ack on the look-and-feel of the Pilot website(s).

o All participating private sector partic ipants will provide a summary of and

the actual feedback received from users who accessed the system.

o EPA hopes to have a response rate greater than 20% (e.g., 2 respondents for every 10 visitors).

September 3, 2009 Page 4 of 7 PPDC Discussion Paper• Evaluate the appropriateness and comp leteness of EPA’s proposed minimum specifications for the web-distributed labeling website.

• Collect feedback from states pesticide agencies, registrants, users, and other stakeholders on the overall pilot, whether the website met their needs, and if

additional functions or feat ures should be considered.

• Capture standard website accessibility metrics

III. Functional Specifications

This section presents the gene ral functional specifications to be used to develop the webdistributed labeling virtual pilot software. Table 1 presents the minimum functional specifications for participation in the Pilot. Ta ble 2 presents optional f unctionality specifications that each private sector participant may wish to include. Failure to include functional specifications would not preclude participation in the Pilot.

Table 1. Minimum WDL Virtual Pi lot Functional Specifications
Category ID Specification

WDL-1100 The system provides a single, intuitive user interface for accessing web-distributed labeling.

WDL-1120 The system provides users the option to retrieve pesticide labeling in both Adobe PDF

and html format.

WDL-1130 The Pilot clearly indicates on each webp age and printed page that any labeling downloaded from the website is for informational/demonstration purposes only and must not be used to make a pesticide application.

WDL-1140 When a user performs search on a product, only one version of WDL can be returned. That is, the database (or databases) makes available to the user only one version as the

“current” version.

WDL-1150 When labeling is printed, each page must identify the state in which the product may be used according to the labeling being printed.

WDL-1200 The system allows users to search for pes ticide products using the following criteria: EPA Registration Number or Product Name, state/territory in which the application is intended to be made, and Use Site(s).

WDL-1210 The system allows users to search for multiple Use Sites.

WDL-1220 Users accessing labeling have to specify th e state/county in which they intend to apply the product to execute a search.

WDL-1270 The website tracks sta ndard website accessibility metrics

WDL-1310 Before being allowed to print labeling, users have to validate labeling to be downloaded for example by verifying an image of the container label or entering the EPA registration number a second time

WDL-1320 The system provides the pesticide labeling in its entirety for the use pattern(s) specified

WDL-1340 The system provides the ability to compare the most recent version of the pesticide labeling to (a) the previous version of the pesticide labeling, (b) a previous version of the pesticide labeling as specified by the user.

WDL-1350 The system timestamps all pages of the pesticide labeling (MM/DD/YYYY, HH:MM:SS) based on when the labeling was rendered

September 3, 2009 Page 5 of 7 PPDC Discussion PaperCategory ID Specification

WDL-1360 The system includes a header on all pages of the pesticide labeling including the Product Name, EPA Registration Number, Page X of Y, and, if filtered, the use pattern(s)/site(s) selected.

WDL-1370 The system displays the date on which the labeling was posted to the website

WDL-1380 The system displays the date on which the labeling was approved by EPA

WDL-1390 The system displays the date on which the labeling was registered by the state authority

WDL-1400 The system provides the option for users to subscribe to an email notification program that alerts the user to the availability of an updated version of the particular product labeling

WDL-1410 Users do not have to enter personal information to view pesticide labeling

WDL-1420 The system clearly indicates any area th at might collect personal information and provides the user an opportunity to acce ss that feature of the system without providing personal information.

WDL-1430 The system provides secure connection capability for companies to upload/edit labeling content

WDL-1450 The system clearly indicates that histori cal labeling must not be used to make a pesticide application

WDL-1460 All portions of the system including all content downloaded/printed from the system include a legal disclaimer as specified by EPA's Office of General Counsel

WDL-1470 The system provides the option for users to specify the font size for viewing/printing the labeling

WDL-1480 The system provides the ability for users, especially those with slow internet connections, to receive pesticide labeling via email

WDL-1490 The system permits users to bookmark the website, but it prevents users from bookmarking specific pesticide labeling

Table 2. Optional WDL Virtual P ilot Functional Specifications
Category ID Specification

WDL-2100 The system provides a standardized format for pesticide labeling

WDL-2120 The system offers users access to add itional, non-labeling content, e.g., demonstration videos, rate calculators, MSDS sheets, etc.

WDL-2130 The system provides the option to refine search criteria by application method and application type.

WDL-2140 The system provides the ability to download historical versions of pesticide labeling

WDL-2150 The system allows users to compare labelin g and portions of labeling from two or more versions of labeling (current, historical, or a combination thereof).

WDL-2160 The system allows users access county-specifi c information (e.g., endangered species bulletins).

IV. Implementation Strategy

This section presents an approach and tenta tive schedule for implementing a web-distributed labeling pilot. EPA anticipates that the three main stages of the strategy will be participant identification, Pilot executi on, and Pilot follow-up.

A. Participant Identification

In an effort to solicit participation from a wide variety of vendors, including those that may not be entirely familiar with OPP’s mission, the Agency anticipates performing the following actions:

September 3, 2009 Page 6 of 7 PPDC Discussion Paper• Create a webpage on the EPA website outli ning a description of the Pilot, the functional specifications, and how to contact EPA to express interest.

• Announce the availability of the website , including a brief background of the WDL Pilot, in the Federal Re gister and through a listserv.

Once identified, participants will engage in a dialogue with EPA to gain a better understanding of EPA’s expectations for Pilot pa rticipants and to request feedback on the proposed approach. The Agency will encourage participants to maintain this dialogue, to the extent appropriate, throughout the execution of the Pilot.

B. Pilot Execution

After meeting to clarify expect ations for the Pilot, participants should independently or collaboratively develop their version of the WDL Pilot. This should include providing EPA with instructions for accessing the P ilot website, the dates during which the participant intends to conduct a nd gather feedback on the Pilot, and a tentative date for meeting with the Agency to present an analys is of the Pilot includi ng feedback received. EPA will also schedule at least one meeting during Pilot execution during which all participants will have the opportu nity to report on the status of their Pilot and present any issues or information that may benefit EPA or other participants.

C. Pilot Follow-Up

At the conclusion of the Pilot, each particip ant should prepare and pr esent an analysis of the Pilot including feedback received and a program assessment as specified in this document. EPA will post a summary analysis of the entire Pilot program on the website.

D. Schedule

A tentative schedule for implementing the Pilot within 18 months is presented in Table 3.

Table 3. WDL Virtual P ilot Tentative Schedule

Pilot Phase Milestone Responsible Party Elapsed Time (months) Create webpage on EPA website with instructions for participating in Pilot; publish notice of availability of webpage in Federal Register EPA 0 Participant

Identification

Submit expression of interest to EPA Participants 3 Conduct kick-off meeting EPA/Participants 4 Develop web-distributed labeling pilot website Participants 8 Pilot Execution

Conduct and gather feedback on the Pilot websites Participants 14 Analyze feedback received on th e Pilot website Participants 16 Present analysis to EPA Participants 17 Pilot Follow-Up

Post combined results of program assessment EPA 18

September 3, 2009 Page 7 of 7 PPDC Discussion Paper