1 Web

- Distributed Labeling for Pesticide Products Pesticide Registration Notice

Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products

Attention: Persons Responsible for Initial and Continuing Federal Registration of Pesticide

Products

Subject: Web

- Distributed Labeling for Pesticide Products

This is a draft notice seeking public comment. EPA will consider the public comments received and may rev ise this notice before publishing a final version of this guidance.

This Notice presents the Agency’s guidance on optional participation in web

- distributed labeling for pesticide products. The Agency believes that voluntary adoption of these recommendati ons by pesticide registrants will help pesticide users to better understand and comply with pesticide labeling. In addition, the Agency believes that web

- distributed labeling could allow addition of new uses, modification of existing labeling requirements, and implementation of labeling

- based risk mitigation measures more quickly. Registrants who wish to use these statements should

follow the instructions in this notice. EPA undertakes initiatives such as this in order to make access to specific pesticide product labeling clearer and more user

- friendly . The specific label ing statements recommended in this Notice are intended to improve existing label ing by allowing users to download the portions of the pesticide labeling specific to their intended state and site of use. No registrant is required to take any action in response to this notice.

I. Products Potentially Affected by This Notice

This Notice is targeted to pesticide products marketed primarily to applicators for use in the course of commercial activity, such as commercial applicators applying to agricultural, turf, structural sites, and private applicators in the course of producing an agricultural commodity . If you have ques tions on whether or not this Notice applies to your product, please contact the EPA Product Manager or Regulatory Action Leader

.

II. Scope of Policy This PR Notice provides guidance to pesticide registrants and to EPA. Although EPA encourages registrants to adopt the following options for making labeling content available via the internet

, this notice is not binding on either EPA or pesticide registrants, and EPA may depart from this guidance in individual circumstances. Likewise, pesticide registrants wh o voluntarily choose to participate in this initiative may assert that the guidance is not appropriate for a specific pesticide

or situation.

I I I. Background Since 2007, the U.S. Environmental Protection Agency (EPA or the Agency) has been exploring

the feasibility and advisability of allow ing registrants to make legally enforceable pesticide product labeling available to users via the internet , an initiative referred to as “web

- distributed labeling” (WDL) . At the end of 2010, EPA initiated a “user acce ptan ce pilot ” that ran until April 2011. (75 FR 51058, August 18, 2010; EPA

- HQ

- OPP

- 2010

- 0632) The user acceptance2 pilot involved a simulation of a WDL website that users could visit and on which they could provide feedback. The user acceptance pilot did not involve any changes to existing pesticide labeling on containers or legally valid electronic versions of pesticide labeling. EPA also published a Federal Register notice that outlined EPA’s positions on issues related to WDL and also sought comment on a number of these issues. (75 FR 82011, December 29, 201 0 ; EPA

- HQ

OPP

- 2010

- 0648)

Based on its review of the comments and other feedback received from the Federal Register

notice and the user acceptance pilot, EPA is proposing a voluntary approach to WDL that w ould allow registrants to distribute pesticide products with labeling that refers the user to the website from which the user may download legally valid, enforceable labeling. The container would still be accompanied by a physical copy of the EPA

- a ccepted labeling sufficient for the correct use of the product , but a user could access the most current version of the state

- and site

- specific labeling from a website identified on the container label. Offering WDL while retaining the full labeling on o r accompanying pesticide containers would allow users, registrants, and EPA to acquire a better understanding of the strengths and limitations of WDL and possibly serve as a transition to a system that relies more heavily on the internet and other technolo gies to provide users with legally enforceable labeling. For example, registrants could determine whether specific types of products would be better suited to WDL and users could evaluate the relative benefit of WDL versus the current pesticide product la beling.

As considered by EPA, WDL would make available via the internet site

- and state

- specific use directions for pesticide products as downloadable electronic files. To access this labeling, a user would visit the website identified on the pesticide l abel, enter information identifying the product, and select the intended state and use site. The website would return a streamlined version of the pesticide labeling containing the language applicable to all products, such as

hazard and first aid statemen t s , and the relevant state/site specific directions for use (e.g., application to cran berries in Maine )

. Sufficient labeling for the correct use of the product, i.e., the labeling currently included on or with the container, would still be available with t he pesticide either on the container label or in accompanying material

.

This PR Notice provides guidance about how EPA intends to implement WDL under this

system.

IV . Discussion of Issues and Recommendations

A. Term inology in this Notice

The list of terms below provides a description of the meaning of each term for the purposes of this notice only. These definitions do not supersede or otherwise alter any definitions contained in FIFRA or EPA’s pesticide regulations.

1. Master label ing

– The complet e set of EPA

- accepted labeling information, including all approved uses and associated use information for a pesticide product registration, regardless of whether the complete presentation is actually distributed or sold with the product.3 2. Released for shipment

– A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be distributed or sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where finished products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product re mains in the condition of being released for shipment unless subsequent activities, such as relabeling or repackaging, constitute production. (40 CFR 152.3)

3. Rendered output

– T he final version of WDL returned to a user for a product where the user

h as perform ed a search for labeling using the product’s unique identifier, a state and specific site

.

4. Unique identifier

– For the purposes of this PR Notice only, an alpha

- numeric combination used to distinguish the labeling for a specific version of t he product from other products with the same registration number and different labeling as permitted under 40 CFR 152.130(b). The registrant would need to establish a new unique identifier if a change in the labeling would render the previously approved v ersion of the labeling invalid, for example, in the event of a change to the precautionary statements, use classification, or packaging of the product. For example, if product A’s labeling version 1 advised users that the product was flammable, and the

re gistrant reformulated product A to eliminate flammability, product A’s labeling version 2 would need a different unique identifier than product A’s labeling version 1. The unique identifier must start with the EPA registration number and must be distingui shed from the EPA registration number, establishment number, and distributor number. Registrants would develop the unique identifiers for each product to which WDL would apply. The unique identifier should be identified clearly as the unique identifier.

B. Description of Process for Adding WDL to a Product’s Labeling

Each registrant wish ing to use WDL submits an application for amended registration containing new labeling statements as described in more detail below. (See Section V.) If EPA approves the application, the registrant would be responsible for creating, publishing, and maintaining the

websi te containing the WDL. This would be in addition to all other regulatory requirements related to pesticide registration and labeling. WDL would not change EPA’s policies about and requirements for submission and review of final printed labeling. Registr ants c ould control the formatting of the rendered output of the labeling , so long as the rendered output conformed to the existing applicable requirements at 40 CFR Part 156 (e.g. 40 CFR 156.10(a)(2))

.

Users would follow the URL on the pesticide container label to the appropriate website. They would enter the unique identifier for the product and state, and then select the use site from an established list of some or all uses approved on the master labeling for inclusion as part of the WDL (known as a “pick list”; see http://www.epa.gov/pesticides/foodfeed/ for EPA’s recommended terminology for some commodities). The website would return a streamlined version of labeling that includes all gener al information from the labeling and only the use

directions and restrictions related to the specific state and site of use. The user would verify that

the date on the WDL rendered output was later than the container’s released for shipment date (i.e., WD L labeling would be legally valid only if it bore an approval date on or after the released4 for shipment date) . The user could print the WDL , save it electronically, or view it. Printing the WDL would not constitute production by the user as defined at 4 0 CFR 167.3. See 75 FR 82011, 82022; December 29, 2010. The user would be responsible for complying with either the WDL or the container labeling. Also, the user would be responsible for complying with applicable requirements (e.g., state regulations) t hat require users to maintain a copy of the labeling used for application. The use of WDL would not impose any additional recordkeeping requirements on

users.

C. New Labeling Statements

In order for WDL to be enforceable, the pesticide product’s container label needs to reference the

WDL. See FIFRA § 2(p)(2). The Agency is recommending a statement be added to the container

label of each pesticide product us ing WDL and on the rendered out put of the WDL

. For WDL labeling to receive EPA approval, the statement should: (1) direct users to the relevant website, (2) note that the electronic version of the labeling is also legally valid, and (3) inform users in

cases where the additional labeli ng conflicts with the container label, the user may choose which version of the labeling to follow. The statement should make clear that for areas of overlap or conflict, the user must use only one set of labeling instructions, either the attached contain er label or the downloaded labeling. This statement should appear at the beginning of the directions for use and might read as follows:

“You may obtain additional labeling from {i nsert website URL}. If using the additional labeling to make an applicati on of the product, 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 any additional labeling, including any web

- distribu ted labeling. In instances where

the additional web

- distributed labeling conflicts with the container label, the user may choose a single, valid version of the labeling to follow. However, for areas of overlap or conflict, the user must use only one set of labeling instructions,

either the attached container label or the web

- distributed labeling.”

To facilitate linkage to labeling that changes over time, p esticide labeling for products using

WDL sh ould bear a released for shipment date and a unique iden tifier. These pieces of information would be used to match the product with the correct set of WDL. The released for shipment date and unique identifier, both clearly identified as such, must appear either on the pesticide container or on the labeling. The labeling should inform the user of the specific location on the container or labeling of the released for shipment date and unique identifier. This

statement should follow the WDL statement listed above.

“The released for shipment date is in DDMMYYY Y format and can be found {location, e.g., on the neck of the container} . The unique identifier format is {format, e.g., 10 character alpha

- numeric combination} and it can be found {location, e.g., on the neck of the container}.”

The first page of the rendered output of WDL sh ould include a statement indicating the legal validity of the label and explaining how labeling must be followed when different versions are5 available to the user. For example, WDL could contain the following statement in a prominent location, for example, at the top of the page :

“This labeling is legally valid only for use in {state} and only with container of product { name of product & unique identifier} that bears a “released for shipment” date on or before { date of we bsite access }. For pesticide applications following this labeling, you must possess a copy of this labeling at the time of application. If this labeling conflicts with labeling found on the pesticide product, use only one set of the labeling instructions in its entirety. Do not mix and match labeling directions. ”

“ Currently the user is responsible for complying with the requirements of product labeling obtained when the user took possession of the product’s container. The user must comply with all instructions and requirements in the labeling [FIFRA § 12(a)(2)(G)] and must keep the labeling as long as the user has the container [FIFRA § 12(a)(2)(A)]. Similarly, the user who relies upon WDL may meet this requirement by maintaining a copy of the labeling or using some other form of recordkeeping in order to meet FIFR A’s requirements. In the situations described above where the WDL labeling conflicts with labeling on the pesticide container,

the user must be able to identify which labeling was used and followed at the time

o f the pesticide’s application.”

Subsequent pages of the labeling should include an abbreviated legal statement that references the primary statement on legal validity of the labeling. For example:

“This labeling is legally valid only for use in {state} and only with the container of {name of prod uct & unique identifier} that bears a “released for shipment date” on or before {date of website access}. See page 1 of this document for additional legal requirements on the use of this labeling.”

The registrant also should ensure that the web

- distribut ed labeling, if printed, includes on each page the following statements:

“This web

- distributed labeling was rendered by accessing {website} on {date}.”

“{Product name} Web

- Distributed Labeling

– Page {page number} of {total pages}.”

In addition to t he information and statements listed above, the registrant may include a Quick Response code or a similar symbol capable of being scanned by handheld devices to connect to the internet and to return the website listed on the container label or accompanying material

. Per Section 2(p)(2) of FIFRA, t he content the Quick Response code or other similar symbol references would be considered labeling and therefore subject to review by the Agency.

D. Website

1. WDL Content6 After the user searches by unique iden tifier, state, and site, the website should provide the user with the general labeling content that applies across all use sites as well as the content specific to the use site(s) requested by the user. T he labeling content provided to users should be

sub divided by use site and state. Additional subdivisions, such as application method, may be acceptable on a case

- by

- case basis.

The WDL rendered output should also include the statements and content listed in Unit I II .C . or equivalent . The rendered form at of the labeling must conform to existing applicable standards at

40 CFR Part 156

.

Where practicable, all WDL website functionality and rendered output should be accessible by handicapped individuals.

2. Website References on Labeling Registrants (or their content providers) may develop a website for WDL distinct from existing

websites. The simplest WDL URL would direct the user to a website where he or she could input the unique identifier, state, and site of application. The website would return only the WDL requested by the user. Any links from this WDL website to other information could clearly indicate through a disclaimer statement that the user is exiting the portion of the website considered labeling and going to a website that is not part of the product’s labeling.

Should the registrant wish to add or retain a reference to the company’s website on the labeling, including by directing the user to the registrant’s primary website to download labeling, the registrant should be aware that the website becomes labeling under FIFRA and is subject to review by the Agency. For examp le, if the container label directed the user to www.registrant.com to download the WDL, all content on www.registrant.com would be considered labeling. If the website is false or misleading, the product would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40 CFR 156.10(a)(5) list s examples of statements EPA may consider false or misleading.

In addition, regardless of whether a websi te is referenced on the product's label ing , claims made on the website may not substantially differ from those claims approved through the registration

process. FIFRA section 1 2(a)(1)(B) . T herefore should the Agency find or if it is brought to our

atten tion that a website contains claims substantially differing from the EPA approved registration, the website could be referred to the EPA's Office of Enforcement and Compliance

Assurance.

3 . Website Function EPA will consider website functionality when deciding whether to approve an amendment to add

WDL. In order to ensure that the WDL website, and thus pesticide labeling, is readily available

to users, ideally, t he website w ould have minimal down time and be accessible 24 hours a day, every day of the year, and be available 99.9% of the time. The website would also have a

reasonable minimum response time. The content provider should consider the potential number of people that may attempt to access the site at one time.7 Registrants (or their content providers) should not limit users from accessing labeling content through the website by requiring users to log in or pay a fee even where other non

- WDL services

do require users to log in or pay a fee. The website should not require advanced (i.e., more than current common computer capabilities or standard software) computer systems or software. The labeling content should be provided, at a minimum, in PDF format, although registrants may

choose to make WDL available through other technology, such as tablets or smart phones. Users should not be required to download software specific to the WDL site , other than the Adobe

Acrobat Reader available for free download

. The website should direct users who do not have the Adobe Acrobat Reader program installed on their computers to the website where users can download and install the program.

The website URL should be easy to read and easily identifiable, generally with no more than 25

characters. The URL should l ink directly to the WDL webpage where the user can search for the labeling content by unique identifier, state, and use site. When designing websites, registrants should be aware that many rural areas still lack broadband internet access.

4 . Website Se curity Registrants should ensure secure access to upload or change labeling on the WDL website. Registrants would be responsible for ensuring that the content of the WDL site, including labeling, is accurate and up to date. Registrants should ensure the labeling provided from the WDL website (rendered output ) cannot be altered by users. EPA recommends that registrants maintain an audit history for users performing any activity other than accessing labeling.

5. Website Usage Data

In order for the EPA to a nalyze the success, needs, and future direction of the WDL program,

EPA may consider includ ing a condition on the registration requiring the registrant to submit the website usage data to EPA

. Note: EPA does not wish to receive information that identifie s specific users of the website and such information should not be submitted. Website usage

information could include:

• Number of website hits

• Average time user spends on the website

• Number of downloads/printed labels

• Other web content that is provided

o Other content that is accessed by the users

EPA may require t his information not only as totals, but also by product, by state, and by use site

. If submitting confidential business information (CBI), clearly mark it confidential. CBI

will be handled in accordance with 40 CFR Part 2 subpart B and where applicable 40 CFR

158.33.

V. What Registrants and Applicants Can Do A. Adoption of Web

- Distributed Labeling To initiate the process of adding WDL to an existing product registration, the company would

file an application for an amendment with EPA. In addition to any other required elements of the application, application s that incorporate WDL should include the master labeling and examples (preferably at least two) of the labeling in the rendered outp ut (state

- and site

- specific labeling).8 Adding WDL to an existing product registration is not necessarily an action covered by the Pesticide Registration Improvement Act (PRIA). Submitting an amendment that only seeks to add WDL to labeling would be a no n

- PRIA Fast Track action. However, a registrant could include an application to amend labeling to include WDL as part of an action covered by PRIA, such as adding a new use site.

To add WDL to a new product’s labeling, the registrant would include the master labeling and examples (preferably at least two) of the labeling in the rendered output (state and site

- specific labeling) with the package seeking to register a new product.

Registrants could submit WDL to EPA as electronic files, such as a link to the appropriate website or a PDF file. EPA would also accept printed copies of the WDL for review.

As part of the approval process , EPA may review the website, URL, and the rendering of labeling content through a link to a draft of the website not available to the public . EPA may ensure the URL is easy to read and that it directs the user directly to the WDL webpage. EPA may also review the website on a case

- by

- case basis to evaluate ease of use. EPA would also review the labeling in the rendered output to determine, on a case

- by

- case basis, if it correctly reflects the approved master labeling. Note: Only the master labeling would be stamped "accepted"; the sample rendered WDL labeling would not be stamped. As a condition of approval of the amendment, EPA may require the registrant to amend the website to provide updated labeling within a specific timeframe after the revised labeling receives all necessary approvals from EPA and a state. EPA antici pates that it would require registrants to provide updated labeling within a specific time frame if necessary to implement risk mitigation measures. For other changes, such as adding a new use, EPA would likely leave the labeling amendment

schedule to the discretion of the registrant, provided the labeling and website are updated within 18 months of approval by EPA as is the standard timeframe for updating labeling when new labeling is approved. See 40 CFR 152.130(c).

Upon EPA approval of the labeling, E PA recommends that registrants provide at least 2 versions of the final WDL in the rendered output (state

- and site

- specific labeling) to EPA, in addition to the final printed labeling as required by 40 CFR 156.10(a)(6)

.

B. Supplemental Distributors

The l abel of a distributor product must be the same as the label of the parent product, except as provided in 40 CFR 152.132(d). If the primary registrant for the product uses WDL, the supplemental distributor of that product can choose whether to participate in WDL for the supplemental ly distributed product under the terms of the agreement between the primary registrant and supplemental distributor . However, if the primary registrant does not use WDL for a product , the supplemental distributor of that product may not use WDL for that product

.

V I . Effective Dates This Notice represents a proposal. EPA will not begin accepting applications to use WDL for product s until the Agency publishes a final Notice.

V I I. Addresses to Use9 Registrants should send notifications and amendments to one of the following addresses:

U.S. Postal Service Deliveries The following official mailing address should be used for all correspondence or data submissions sent to OPP by U.S. mail:

Document P rocessing Desk (AMEND) (Distribution Code as identified in PR Notice 2006

- 1) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency Ariel Rios Building1200 Pennsylvania Ave., NW Washington, D.C. 20460

- 0001

Personal/Courier Service Deliv eries The following address should be used for all correspondence or data submissions that are hand

carried or sent by courier service Monday through Friday, from 8:00 AM to 4:30 PM, excluding Federal holidays: Document Processing Desk (Distribution Code a s identified in PR Notice 2011

- X) (AMEND) Office of Pesticide Programs (7504P) U.S. Environmental Protection Agency

Room S

- 4900, One Potomac Yard 2777 South Crystal Drive Arlington, Virginia 22202

- 4501

VIII. For Further Information If you wish to obta in further information on this notice, please contact Michelle Arling, arling.michelle@epa.gov , 703

- 308

- 5891. For questions about a specific product or active ingredient, please contact the product manager.

IX. Specific Areas for Comment

A. Would an appendix with sample master labeling and web

- distributed labeling rendered output assist in understanding the PR Notice and how to follow the recommendations in the PR

Notice?

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

ways to desc ribe the targeted products?

C. Should the Agency consider combining the released for shipment date and the unique identifier into a single alpha

- numeric combination? If so, why? Please provide suggested definitions for any proposed alternative.

D. Shou ld the released for shipment date and unique identifier have a standard location on the container or pesticide labeling? If so, where? If not, why?10 E. Should EPA approve web

- distributed labeling for one or some, but not all, uses listed on a product’s l abeling? If so, how would users know that no web

- distributed labeling was available

for their intended use?

F. Should EPA consider only accepting WDL submissions to the Agency for review as electronic

files?

G . Please provide comments on the web

- distributed labeling statements and their recommended location. Should they be located at the beginning of the directions for use? Should they be a separate section on the labeling, similar to the Agricultural Use Box that conveys information

about t he Worker Protection Standard? Would either approach make the user more likely to read and comply with the information?

H. Please provide comments on the minimum functionality discussed in Unit IV. D. Are the proposed standards reasonable? If not, plea se suggest alternative guidelines.

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

___________________________ Dated:_________________ Steven Bradbury, Ph.D., Director Office of Pesticide Programs U.S. Environmental Protection Agency