Web-Distribution of Labeling Workgroup Discussion Paper Website Fu nctionality
Issue The prim ary goal of web-distributed labeling is to m a ke the most current version of stateapproved marketed prod uct lab e ling available to us ers electro n ically. In o r der to facilitate acces s to the breadth of infor m a tion that will be available, what m i nimum functionality is necessary for the web-distributed labeling website to m eet this goal? W h at enhanced capabilities should be considered ? Assumptions
• Other issues associated with web-distri buted labeling (e.g., web- distributed labeling lifespan, scope of web-distribu ted labeling, and potential hosts for the website portal and databas e s) are beyond th e scope of th is discu ssion paper and will be add r essed separately.
• Any option for web-distributed labeling website functiona lity should not result in unfunded mandates on states or requirem ents for states to change their existing inf r astru c tu r e f o r reviewing a nd approving container labeling.
• The host(s) of the web-distri buted labeling website will be ab le to m eet th e m i ni mu m standards necessary to provide the functionality recomm ende d.
• The website (s) ope rato r(s) will ensure near 24 /7 access and p r ovide prompt custom er support. Background For certain products, EP A is currently exploring the concept of distributing pesticide labeling inform ation over the internet as web-distributed labeling. The goal of this project is to have a website or w e bsites that could provide users, the public, States, registrants and EPA wi th the ability to download and print labe ling for a specific pesticide product. For purposes of this discussion, there are two type s of labeling: “m aster labeling” and “m arketed product labeling.” W h en EPA reviews and appr oves an application, the resulting “m aster labeling” reflects all of the uses that EPA has allowed to be regist ered for the specific product. After m a ster labeling is generate d, E P A regulations allow the regist ran tto sell the pes t icide with m a rketed product labeling that is consistent with the “m aster labeling.” In m a ny cases registrants choose to sell products containing onl y a subset of the full range of EPA-a pproved uses; in f a c t , in a sing le s t ate, registr a nts m a y have mu ltiple v e rsions of marketed prod uct labeling for the sam e EPA-registered pestic ide. Thus, the “m arketed product labeling” frequently differs from the m a ster labeling. For purposes of discussion, the term “ m arketed product labeling” refers to the following: th e label physically attached to the container (“container label”), any paper labeling accomp a nying the p r oduct (“container labelin g”), and in the future, any “web-distributed labeli ng” associated with that product. States require registrants to s ubm it and obtain state registration fo r any product to be legally sold and distributed in their state. States have different requirem e nts for what registrants mu st subm it

–som e states require th e labeling for each vari ation of a single product (e. g. labeling for each contain e r s i ze, fragrance, etc. of Bran d X insect icide), while others accept one version of labeling per product (e.g. one set of labeli ng f o r all Brand X insecticide products that differ only in

Nove m b er 18, 2008 Page 1 of 7container size, fragrance, or othe r m i nor characteristics ). Pes tic ide users are required to comp ly with m a rketed product labeling. To address the variations in state pr ogram s, web-distributed labeling will use a uniqu e identifier f o r each state re gistration of a product to ensure that the user can obtain the labeling for the specif ic product to be used. As the Agency m oves closer to developing a pi lot for web-distributed labeling, it m u st decide what website functionality would best serve al l stakeholders. This paper discusses which functions are critical elem ents of the website, and which would be helpf u l and encouraged, but are not n ece ssary. The m i nimu m f u nctiona lity o f th e website will af f

e ct which entity or entities could host the website portal(s) or database(s). Critical Functionality To achieve the goals of web-distributed labeling, the website must be able to do the following:
1. House current and accu rate, as well as histo r ical versions of web-distribu ted lab e ling Housing the most curren t and accurate version of web-distribu ted lab e ling is critical to imple m enting this program. A m a jor benefit of web-distributed la beling is that it will p u t the most current version of m a rketed product labeling into users’ hands m o re quickly than under the existing pro cesses and p r ocedur es. This will b e nef it the pub lic and envir o nm ent by getting risk m itigation m easures and updated label requ irem ents in to the field sooner than under the current paper-based system , registrants by allowing them to am end labels to add or delete uses and have the changes realized almost im m e diately in the m a rketp l ace, a nd users by giving th em access to new or am e nded use directions m o r e quickly.
In order to achieve these benefits , the host of the website (or author ized adm i nistrator) mu st have the ability to post the revised labeling promptly af ter approval. Likewise, us ers should be able to access the labeling p r omptly after it is approved. When the most current v e rsion is do wnloaded and prin ted, it will requ ir e a tim e/ date stamp for when it was printed as well as when the labeling expires. In addition, the printe d labeling will bear the sam e uni que identif ier as the label on the container. (See Labeling Lifespan Issue Paper.) Pesticide labels and labeling ar e often critical components of enforcem ent actions. Under the web-distributed labeling system , updates to m a rketed product la beling will likely occur m o re quickly than under the existing syst em. Often, enforcem ent actions are not imm e diate; therefore, it is n eces sary for State and Federal enforcem ent staff to have access to historical v e rs ions of pesticide labeling. For these reasons, the website mu st also host histor ical versions of webdistributed labeling.
2. Provide access to web-distributed labeling

• Access m a rketed produ ct lab e li ng approved in a specific state Pesticide us ers are requ ired to comp ly with m a rketed product labeling approved and/or registered in the state in wh ich the product will be used. In order to improve label comp liance with current and accurate versions of pesticide lab e ling, users must be able to conduct the initial search for labeling by state.

Nove m b er 18, 2008 Page 2 of 7• Retrieve portions of the labeling segm en ted by use on a specific site (e.g. use on apples) Currently, som e labeling that accompanies a product is very long, dense and confusing. Users should be able visit the web-distribu ted labeling website fo r the state-approved labeling for a specific product and print only the relevant parts of the label for the intended use. For example, a grower usi ng a pesticide on apples should be able to download the required portions of th e labe l re late d to apple s , not for all registered or labeled uses. By providing only the appropriate use directions for a pples , the lab e lin g is not cluttered with specific inform ation for other crops. Reducing the am ount of inform ation presented to the user to that wh ich is necessary (F IFRA m a ndated labeling elem ents, specific use in structions ) creates simp ler lab e ling a nd elim inate s unnecessar y paper use. S horter, less confusing labeling could increase the like lihood that users will read the labeling comp letely and follow all instructions, rather than skimm i ng a long docum ent and potentially m i ssing critical protection inform ation.

• Provide access reliably The website would need to operate in a m a nne r that is acces sible at any tim e and could handle as large a num ber of requests for infor m ation as could reasonabl y be expected. In all likelihood, EPA would need to specify som e perform a nce st andard f o r the ava ilab i lity of the website.
3. Have a user-friendly in terface and be easy to nav i gate The website(s) will be utilized by a wide cross-s ection of pesticide user s, regulators, and the general public. Som e of the user s m a y have little to no experien ce navigating the Internet. In order to encourage utilization of the web-distributed labeling syst em website, it is importan t tha t it be intuitiv e and easy f o r an inexp e rienc e d Inter n et user to navigate. For example lists and drop down m e nus should be utilized wh ere possible. [Note: The specific characteristics w h ich would m a ke a website “easy to navigate” will d e pend to a signific a n texten ton the functiona lities the website is expected to h a ve. Th ere will also be alternate delive ry m e thods via phone, fax or m a il by which users can obtain web-distributed labeling.]
4. Enforce appropriate secu rity and access rights To apply pe stic ides in a safe, lawful m a nner, us ers will re ly o n the information a ccess e d from the web-distribu ted lab e ling website( s ). Theref ore, it is cr itical th at the applic ation ’ s des i g n will m i ni m i ze the possibility of unauthorized users up loading, editing or otherwise tamp ering with web-distribu ted lab e ling inform ation. For exampl e, the sys t em will m a intain password-protected access and an audit h i sto r y for users perform i ng any activity other than accessing lab e ling (e.g. uploading w e b-distribut ed labeling).

Nove m b er 18, 2008 Page 3 of 7Other Pot e ntial Funct i onalities
The functionalities described below could benefi t stakeholders, but are not critical components of a web-distributed labeling system

. These functionalities would e xpand on the critical functionalities outlined above by providing enhan ced search capabilities, more refined label retrieval, an d links to no n-labe ling resources. Although EPA will c ons ider the inclus ion of these elem ents as part of web-distributed labeli ng, we recognize th at they are n o t necessary

.

• Single URL to access web-distribu tedlabeling; s t atic web-d i stributed labeling sites A single URL, e.g. www.webdistributedlabeling.com , would allow users to visit a single website to search for and download all labeling. All m a rketing and outr each m a terials could focus on a single m e ssage and website, rather than instructing users to find and visit the website listed on each contain e r. Users co uld enter the product re gistration num ber or ano t h e r unique id entifier to access the labeling for th e specific p r oduct.
Static web addresses for web-di stributed labeling could be used for bookmarks and shortcuts. For example, www. webdistributedlabeling.c om /ProductX_current.htm would always link to the current labeling for Product X. This static web address could function in several ways: allow the user to choo se the s t ate where the pesticide will be applied and enter th e registration num b er or unique identifier, or link directly to the m a rketed product labeli ng. This w ould allow users to ensure that they are always linki ng to the current vers ion of the labeling w ithout having to search through the website.

• Highlight changes to the labeling Users frequently purchas e the sam e product year after year. Once they are fa m iliar with the labeling requirem ents, they m a y not take the tim e to re ad the labeling car e f u lly each tim e they use the product. In order to assist with co mp liance the system should be able to highlight changes (e.g. application rate, new uses, new re strictions) m a de within a certain tim e period. This period could be linked to the lif espan of web- distributed labeling or ba sed on other factors.

• Access related m a terials, such as m a terial safety data sheets (M SDS), training m odules, m a nuals and reference m a terials. Although not a critical component of pesticide labeling, ancillary m a terials that support the safe use of a pesticide are valuable to ols. Registrants coul d use this feature to provide inform ation to its custom ers that is not required to be part of labeling, but could be benef i cial to users. Training organizations could use the platform to provide tr aining m a ter i al rela ted to specif ic app lica tion techniques such as calibration of nozzles for ae rial application. Users could benefit f r om the additional knowledge.
In order to include this functiona lity on the website, it would have to be d i f f

e rentia tedf r om the elem ents of pesticide labeling with which the user is required to comp ly. Disclaim er language would need to be added to inform the website users that by linking to the ancillary m a terials, they are leaving the official pe sticide labeling. Otherwise, cha nging, adding or deleting links or

Nove m b er 18, 2008 Page 4 of 7pages for non-labeling m a terials could be consider ed labeling and would in crease significantly the burden on EPA and States to review all m a teri als, and on registrants to notify EPA and States of all chang e s. Som e of the product-specific ex ternal resources could include: a. Mater i a l Saf e ty Data She e t b. Worker Protection S t andard Training Materials c. Endangered Species Protection P r ogram Website d. National Pe s tic ide Inf o r m ation Center e. Comp any contact information (see Error! Reference source not found. ) (Note: we want to m a ke it clear that questions on product infor m ation shoul d be directed to comp anies whereas questions on use directions, etc. should be directed to states or EPA) f. Inciden trep o rting (s tate and Federal) g. Poison control hotline h. “How To” docum e nts and videos (e. g., how to calib rate a sp rayer, how to m itigate spray drift, how to appl y aquatic pesticides) i. Links to definitions and photographs of comp liant PPE (e.g., label requirem e nt to use a respirator with MS HA/NIOSH approva l number prefix TC-21C links to a representative photograph) j. Product-specific technical bulletins a nd FIFRA Sec 2(ee) recomm endations on tank m i xes, application tim i ngs, and adj uvants to enhance efficacy and/o rreduce crop in jury k. Inform ation on state clean sweep program locations and dates l. Inform ation on container recycling or disposal m. Inform ation on resistance m a nage m e nt and IPM n. Access to fillable form s (e.g., fum i gation m a nagem e nt plans) o. Stewardship inform ation p. Rate calcula tor i. Pounds active ingredient per acre (or other appropriate m e asure used by EPA for risk assessm ent purposes) ii. Units of product per area as specified on product label iii. Application estim ator (i.e., how m u c h of product X would be needed for a user-defin edplot size ap plie d at a us er-defined applic ation rate not to exceed the m a ximu m labeled r a te)

• Search and refine queries across all web-dist ributed labeling products to filter pesticide products by various criteria (e.g. application site, target pest, signal word, personal protection equipm ent required, pre-harvest interval) The cross-cutting search function of any web-dist ributed labeling system could prove to be an important marketing tool to highlight the benefits of web-distributed labe ling to users and other stakeho l ders

. For example, users can use this search function to sear ch all web-distributed labeling products to find those registered in a specific state for use on a specific crop. This search function could also be important to consul tants, dealers, university research and extension staff, and advocacy grou ps.

Nove m b er 18, 2008 Page 5 of 7Som e of the features that could be pa rt of such a search function include: 1. Product locator a. Select product from list/dropdown menu b. Search by manufacturer’s nam e , produc t nam e , active ingredient(s), EPA Registration Num b er, state and use site, target pests, produc t type (Section 3, Section 18, Section 24c) 2. States/counties that perm it application 3. Search by state/county, use site, pest; drop- down m e nus are populated based on previous drop-down m e nu selection 4. Interactive state/county m a p 5. Comp are labels a. Comp are current/historical labels of the sam e product b. Comp are current labels of mu ltiple products c. Toggle “highlight changes” on/off

• Subm it and access the most current and accurate version of master labelin g Currently, th e public can access m a ster lab e ling th rough the P e sticide Pro duct Labelin g System

. As m e ntioned above, the m a ster label contains al l registered uses appr oved by EPA. This does not m ean that States have approved each use fo r a product, or that regi strants have m a rketed every use in every state. Apar t from web-distributed labeling, EPA is developing an E

- label initiative which will include structured labeling content, a searchable m a ster labeling database, and the ab ility for EPA to receive, review a nd approve m a ster labeling electronically. W e antic ipate th at th is datab a se, which will encomp ass all produ cts, will be more comp rehensive than the web-distributed labeling da tabase(s), because it will include all products rather than only those employing web-distributed labe ling. It m a y be possible to us e the structured E P A database to populate the web-distributed labe ling database, either as the pr im ary database or as one of several databases with product inform ation.
Options
Pilot The pilot for web-distrib u ted lab e lin g will likely in clude at most a few produc ts in a few states. It m a y be lim ited to certain uses f o r the par tic ipa ting products. Since this exercise will be lim ited in scope, the associated website does not need to provide each f unctionality outlined above. At a m i nim u m, the pilo t website m u st:
• House current and accu rate, as well as histo r ical versions of web-distribu ted lab e ling
• Provide access web-distributed labeling
• Have a user-friendly in terface and be easy to nav i gate
• Enforce appropriate secu rity and access rights
Full Implementation The f unctio nality of the website f o r f u ll im plem entation m a y evolve, and will depend on the outcom e s of the pilot. A ta m i nim u m, the webs ite mu st includ e the c r itica l elem ents outlin ed

Nove m b er 18, 2008 Page 6 of 7above. Offe ring a search functi on to users would broaden the a udience that could potentially benefit from web-distributed labeling.
• Critical elem ents
• Ancillary mater i als
• Master lab e ling
• State-specific and cross

- state searches

Nove m b er 18, 2008 Page 7 of 7