Web-Distribution of Labeling Wo rk Group Discussion Paper Website Hosting

Issue The primary goal of web-distributed labeling is to make the most current version of stateapproved marketed product labeling available to us ers electronically. This system will require large amounts of labeling language to be available via the Intern et. What should the architecture of the website be and which ent ity or entities should have the responsibility for maintaining the content in the related database(s)?

Background EPA is currently exploring the concept of distri buting pesticide labeling ove r the Internet as webdistributed labeling. Although ma ny sources offer access to labeli ng information electronically, it is available in a variety of formats, there is no single acces s point, and it may be unknown if the posted label is accurate and legally current. Some registrants have websites with information on their own products. Some states have develo ped the capability to pub lish approved labeling by PDF. Third-party websites offe r a variety of Internet access to PDF labeling or information extracted from state-approved labeling.

The goal of this project is to have a website or websites that could pr ovide users, the public, States, registrants and EPA with the following minimum functionality: 1. Access to the most current and accurate version of web-distributed labeling 2. Retrieve portions of the labeli ng related to a specific state and use site (e.g. use on wheat in Kansas) 3. Maintain historical versions of marketed product labeling 4. Easy to navigate A more complete discussion of th e functionality of the web-distributed labeling website(s) is covered in a separate discussion paper.

Apart from web-distributed labeling, EPA is de veloping an E-label initiative which will include structured labeling content, a searchable master labeling database, and the ability for EPA to receive, review and approve master labeling elec tronically. Some states also have systems in place that allow them to review and approve ma rketed product labeling electronically, although there is a high degree of variability in resources and review processes acro ss states. The system for web-distributed labeling may be linked to stat e or EPA websites, but such connections are not a requirement.

As the Agency moves closer to developing a pilot for web-distributed labeling, it must decide what entity or entities should host the website for distribution of stat e-approved marketed product labeling and whether this type of labeling should be accessed through a single or multiple portals & websites. This paper discusse s options for the website portal and databases, and potential hosts and the advantages a nd disadvantages associated with each.

July 14, 2009 1 of 5 PPDC Discussion Paper DraftAssumptions

• Any option for web-distributed labeling website hosting s hould not result in unfunded mandates on states or requirements for states to change their existing infrastructure for reviewing and approving container labeling.

• Any option for hosting would not require users to pay a fee to search for or download labeling.

• Any option for hosting would be consistent with all state regula tions that prohibit charging registration f ees to registrants.

• Any portal will be able to re strict the search by state.

• The database would have sufficient search and refined query functions to deliver streamlined marketed product labeling appropr iate for that state and use site.

• Other issues associated with web-distri buted labeling (e.g. web- distributed labeling lifespan, scope of web-distributed labeli ng, and website functionality) are beyond the scope of this issue paper and will be addressed separately.

Website Portal & Database Options

There are two critical components in the architecture of the web- distributed labeling system: the portal, i.e., the initial website visited by user s or the public to begi n their search for webdistributed labeling, and the data base(s) holding the web-distribut ed marketed product labeling. This section describes the possible combina tions and the advantag es and disadvantages associated with each.

Single Website Portal & Database

A single website and database would begin with one access point for all information related to web-distributed labeling. The information necessa ry to search for and obtain the web-distributed labeling would be maintained in a single database , similar to visiting the website of a small shop (e.g. Washington Local Bookseller) and searchin g the inventory for a particular title.

Advantages:

• Would assure standard delivery format for labeling

• Single access point would be easier for users to remember

• Single database to review for enforcement personnel

Disadvantages

• Large amount of information to be pro cessed and maintained by a single entity

• May require changes in pesticide review and registration proc esses by all entities involved

Single Website Portal with Multiple Databases A single website with multiple databases would be similar to a service such as Amazon. All users visit the Amazon.com website to search for their products, and Amazon searches multiple databases (of warehouses and partner dealers) to provide the requested information back to the user. A single pesticide labeling port al is linked to state, registrant and/or th ird party databases.

July 14, 2009 2 of 5 PPDC Discussion Paper DraftAdvantages

• Single website portal would be easie r for users to remember and use

• Single portal would allow users to search across multiple databases

• Provides for multiple entities to share the responsibility of maintaining and updating databases, including liability for errors.

• Standardized databases would facilitate easier searches for enforcement purposes

Disadvantages

• A standard database format would be neces sary for the search engine to function

• If states are the only entity allowed to supply information to the databases, it may require changes in state procedures

Multiple Website Portals with Multiple Databases Multiple website portals with multiple databases woul d require the user to visit a specific site for each product. It would be similar to the multiple options available to purchase a book online. A user can visit Borders.com, Amazon.com and Barnes&Noble.com but cannot search all three databases at once for information on a title. Ea ch database much be searched separately.

Advantages

• Would allow each entity to maintain data in its own format

• The likely variety in approaches would provide insights into what we bsite design features users found most usable which could be adopted by other sites or as critical functions

• Liability for database errors clea rly falls under the website host.

Disadvantages

• No ability to search across websites

• Increased burden on enforcement personnel to search across multiple websites

• Multiple access points would not be easy for th e user to remember, although the website address for a specific product would appear on the marketed produc t container label.

Potential Website Portal and Database Host Entities

EPA As the Federal authority for pesticide regist ration and regulation, EPA is involved in the registration of all pesticides. It maintains historical records of all master labels submitted and approved, and it is developing a structured databa se for all master labeling content (E-label program). If EPA were to host the website for web-distributed labe ling, EPA would likely operate a single portal website and would likely re ly on other entities (e.g., registrants or states) to provide the electronic file s on state-approved marketed pr oduct labeling that would be accessed by and through the website.

Advantages

• Would provide a centralized database for all products participati ng in web-distributed market labeling

• Would provide a standard form at for all labeling delivery

July 14, 2009 3 of 5 PPDC Discussion Paper DraftDisadvantages

• Economic costs to EPA to develop and maintain

• EPA’s website is not known to be user-friendly

• EPA is not always able to adopt the mo st current technology in a timely manner

• Capturing state approvals of marketed pr oduct labeling could re present a significant challenge

• Questions could arise related to whether EPA or the database provider would bear liability for any labeling errors that are posted, delivered, and followed.

• EPA may not be able or may be less likely th an other potential webs ite hosts to include content/links to commercial sites

States State lead agencies have the final authority to approve marketed product labeling submitted by registrants for sale and di stribution in their states and to cond uct enforcement actions. They also have a closer relationship with users. An appro ach that relies on states to design and maintain websites for web-distributed labeling woul d probably require a single portal.

Advantages

• Having the ultimate approval authority befo re the pesticide labeling enters the marketplace, states are in an excellent posit ion to know what product labeling is approved

• States with electronic approval processes c ould post the accepted labeling immediately

Disadvantages

• High degree of variability across states in te rms of resources and review processes could lead to the need for investment in new state infrastructure

• May impose new resource burdens on states

• May necessitate process changes for states

• States may not be able or may be less likely than other potential website hosts to include content/links to commercial sites

Registrants Registrants manufacture and mark et pesticides. As the entiti es responsible for securing the approval of EPA and States, regi strants have the most complete knowledge of both the master labeling and marketed product labeling. If registra nts were to host websites for web-distributed labeling, they each might choose to operate a site for their own products and also be the source for the versions of state-approved marketed product labeling that would be accessed by and through the website.

Advantages

• Many registrants already post marketed product labeling online in PDF format

• Registrants can generally adap t to new technologies quickly

• With fewer products, the data management task may be easier

• Registrants have knowledge of decisions made at all steps in the registration processes

July 14, 2009 4 of 5 PPDC Discussion Paper Draft• Registrants would be more like ly than other potential webs ite hosts to include content beyond state-approved, marketed labeling

• Liability regarding accuracy of marketed product labeling with registrants is clear

Disadvantages

• Multiple registrant websites could have very different user interfaces; difficult to implement a standard format and search ability

• Differences in website presentation could potentially deter users from purchasing products due to difficulty in locating or understanding web-distributed labeling on various company websites

• Enforcement research across multiple websites could be a resource burden

• Documenting violations might be difficult if registrants can alter websites quickly

Third-Party Vendors Third-party vendors could include for-profit and not-for profit or ganizations. Some provide a service to registrants and states facilitating electronic submission of labeling, or to the public by harvesting available pesticide registration data an d making it available online. Some third-party vendors charge a subscription fee. If one or mo re third parties were to host the website(s) for web-distributed labeling, there could be only one site or multiple sites. Third parties would likely rely on other entities (e.g., registrants or states) to provide the el ectronic files on stateapproved marketed product labeling that woul d be accessed by and through the website(s).

Advantages:

• Could provide a single , searchable site

• Marketplace could encourage quicker a doption of new database-driven delivery technologies to provide a user-frie ndly website and customer service

Disadvantages

• Multiple parties handling data (registrants and third-parties) results in a higher likelihood for errors

• EPA cannot give the impression of suppor ting one vendor over others without going through a competitive process

• Third parties could be less lik ely than other potential webs ite hosts to include content beyond master labeling and state- approved, marketed labeling

July 14, 2009 5 of 5 PPDC Discussion Paper Draft