Web-Distributed Labeling Workgroup Discussion Paper Potential Benefits & Challenges of Web-Distributed Labeling

Introduction During a recent meeting of the PPDC Web Di stributed Labeling (WDL) Workgroup, several group members questioned further investments of time and energy towards implementing WDL until potential benefits of the initiative are identified. The document identifies potential benefits

of WDL to different stakeholde r groups, along with challenges and unresolved issues. This paper explores many of the perceived benefits of WDL that are known today, although additional benefits may be realized as WDL develops.

It is also noted that WDL is initially proposed as a voluntary option for registrants, and WDL would not be appropriate for all pesticide products. Instead, it is likely that WDL would be used primarily for those products with labeling that is long or changes frequently and that are used by people primarily in the course of their business activities. The poten tial benefits described in this paper would be realized only for t hose registrants, users, and dealer s of products that are labeled

with WDL.

Some benefits will be realized by all invol ved stakeholders, although others are more stakeholder-specific. The following are just some of the key benefits of WDL that are discussed in this paper:

● Access to state-specific and site-spe cific streamlined, easy-to-read labeling

● Labeling available in larger fonts

● Improved labeling compliance

● Web linkages to product stewardship information

● Reduced labeling costs and redist ribution expenses to registrants

● Faster access to newly-registered uses

● Faster implementation of risk mitigation measures

● Reduction in multiple versions of labeling in the marketplace

Benefits and Challenges for Specific Stakeholder Groups The following sections outline potential benefits and challenges for:

• Pesticide Users

• Registrants

• Pesticide Dealers/Retailers

• Farm Workers and Worker Advocacy Groups

• State and Tribal Pesticide Regulators

• United States Environmental Protection Agency

August 5, 2009 1 of 12 PPDC Discussion PaperPesticide Users

a. Benefits

1. Access to streamlined, easy-to-read labeling

WDL would be used to deliver streamlined labeling for users, thereby replacing 50-page multi-crop labeling with site-specifi c labeling that is only a few pages. This could make it dramatically easier and faster to ascertain how to safely, effectively, and legally use products. It should also improve compliance with labeling restrictions.

2. Access to larger fonts A common complaint among users is the sm all font size found on many container labels and attached labeling. WDL should make it possible for users to customize font size for printed labeling. Users with electronic versions of WDL can simply use software to enlarge the labeling image on a computer screen.

3. Faster access to newly-registered uses Re-labeling of containers with hard -copy labeling is a time-consuming and expensive process. Because of this, ther e is often a significant lag time in relabeling containers as newly-labeled containers gradually replace existing

containers in the channels of trade. Us ers may therefore be unable to immediately access container labeling that contains newl y-registered uses. They may also be unable to quickly access supplemental labe ling with the newly-registered uses. With WDL, updated labeling could immedi ately be posted on the Internet upon EPA and state approval, making newly-regi stered uses immediately available. This should provide greater fl exibility in deali ng with existing stoc ks of materials since existing containers would not need to be re-labeled with the updated container labeling.

4. Verified access to state-approved labeling Some users make applications in more th an one state, and there is increasing use of Internet vendors to market pesticide products. As stated above, many states require users to comply not only with a product’s container labeling, but more specifically with the labeling approved by th at state. Under th e current system of hard-copy labeling, there is no good mean s for users who buy products in a

different state or from th e Internet to verify whet her the labeling in their possession matches the labeling version appr oved in the state where the product is being applied. WDL could make it much easier for users to verify that the labeling in their possession is approved for use in the state in which they intend to use the product.

5. Improved standardization of labeling Although federal regulations re quire all pesticide labeling to have certain sections, there are generally no requirements for th e order in which those sections are

August 5, 2009 2 of 12 PPDC Discussion Paperfound on labeling. Furthermore, related re strictions and precautions can be found throughout the labeling in diffe rent sections. This lack of standardization can make it difficult for users to find those porti ons of the labeling pertaining to their intended use site. A parallel project to WDL is the electronic submission of pesticide labeling for pesticide registra tions. The electroni c submission process and building websites for WDL may be fac ilitated through the us e of structured product labeling and increased standardization of how labeling is formatted and arranged. Greater standard ization could make it easie r for users to read (and therefore, comply with) labeling rest rictions, precautions, and directions.

6. Better access to product stewardship information The container label on a WDL product woul d direct users to a website to access and download the labeling specific to the pr oduct. The website could also provide

or link to useful information in a ddition to the labeling, such as product stewardship information on reducing drift, choosing nozzles, calculating use rates, state pesticide disposal programs, container recycling, and more.

7. Multiple delivery methods With WDL, pesticide user s would be able to choo se the delivery method and

format of WDL that best meets their need s, including direct download in portable document format (PDF), HTML or PDF vi a email, mobile labeling delivery via text message, barcode scan delivery to a mobile device, FAX on demand, or an email/phone request for a hard copy to be mailed through the US postal system. This flexibility does not exist under th e current system of hard-copy labeling.

b. Challenges & unresolved issues

1. Lack of high-speed Intern et access in all areas Many parts of the rural U.S. still lack high-speed Internet access, and many farmers continue to rely on dial-up modems for Internet access. In addition, not all pesticide users have Internet ac cess of any kind. However, people are resourceful and rely a variety of means to get the information that they need. Also, delivery mechanisms other than direct Internet access will be offered for

WDL.

2. Need for culture change The transition from hard-copy container labeling to WDL will require a significant amount of education of the regulated community. Not all pesticide users may be comfortable with this change , especially if they are unaware of the concept until it is implemented. WDL would not be used for all products so outreach can be targeted to industry sector s. Implementation of a web-distributed labeling system would include sufficient time to transition from the traditional paper-based system, allowing regulators, extension personnel, and others to educate the public.

August 5, 2009 3 of 12 PPDC Discussion Paper3. Expiration dates and older products Under the current system of hard-copy la beling, users can continue to use a product according to the labeling found on the container for as long as they possess the product. The excep tions to this are the rare instances when EPA has

issued a use cancellation date or when a product is no longer regi stered in a state and that state’s laws prohibit the use of unregistered pesticides. This practice allows users to use a product many year s after the product is purchased. With WDL, the labeling accessed at an Internet si te would change over time as uses are

added or removed. This could mean that labeling might not be valid indefinitely. One strategy is to establish an expira tion date for WDL based on download date or production lots. However, the challenge is to establish expiration dates long enough to allow the large majority of us ers to continue using product until the product is completely used, but not so l ong that a user can continue using the downloaded labeling forever. If the expira tion date is too short, some purchasers of pesticides may not be ab le to legally use the comple te contents of a container for the site for which the product was inte nded at the time of purchase. This could create product disposal issues.

Registrants

a. Benefits

1. Reduced labeling costs Labeling containers with hard-copy is extr emely expensive. It is also expensive

and resource-intensive for re gistrants to re-label contai ners in the channels of trade when new uses are registered or existing uses are cancelled. With WDL, registrants could “re-label” large nu mbers of products instantly by simply changing the document accessed at a defined Internet site.

2. More market sector-specific labeling The current paper-based labeling syst em makes it difficult for registrants distribute different versions of labeling for the same product in a similar region without causing confusion. WDL would include stream lined directions on the container label, but most of the site a nd state-specific inst ructions would be included on the downloaded labeling. Re gistrants could use WDL to target marketing and distribution to specific ma rkets, use patterns, or user groups. Registrants could then be confident th at users had ready access to the use

instructions in a more readable format. For example, a product with broad use patterns (turf, industrial, agricultural, forestry) could be marketed differently based on the different uses through WDL.

3. Faster market access

Because of the time involved with re-lab eling containers w ith hard-copy labels,there is a usually a lag time between when uses are registered and when those relabeled containers reach reta ilers and end users. This can delay user access to

August 5, 2009 4 of 12 PPDC Discussion Papernewly-registered uses, even when regi strants use supplemental labeling. WDL

could result in almost instantaneous acce ss of users to new labeling, as well as access of registrants to certain markets.

4. Promotes level playing field Under the current system of hard-c opy labeling, EPA may require labeling revisions for a category of products, for example produc ts containing a specific active ingredient. Even though EPA may es tablish a single date for making such changes, the products from different regist rants or for different formulations from the same registrant can reach the market at different times depending on market forces and differences in supply chains. With WDL, labeling revisions can be implemented simultaneously, promoting a level playing field for different companies marketing the same active ingredient.

5. Faster removal of uses from marketplace Registrants frequently remove uses from pesticide labeling, either voluntarily through marketing decisions or through a re gulatory mandate. Just as it allows for faster market access for new uses, WDL coul d facilitate faster removal of uses from the marketplace.

6. Enhanced Inventory Management All states have a state pesticide re gistration program, making it illegal to distribute or sell (and, in some states, to use) a product that is not registered in the state. In some states, pesticides can also be deemed misbranded if they are distributed with labeling ot her than the labeling that has been registered by the state. Since the version of labeling a pproved in one state may differ from that registered in other states, registrants must manage thei r inventory to ensure that pesticides shipped into a state are appropriately labe led. With hard-copy labeling, this may necessitate the re-labeling of c ontainers prior to shipping products across state lines, or a registrant may simply choose to not market products in certain states if inventory management is not feasible. With WDL, registrants could customize the labeling for a given state a nd site, thereby addressing state-specific differences in labeling wit hout re-labeling containers.

b. Challenges & unresolved issues

1. Tort liability questions There are many concerns about whether the institution of WDL will alter the tort liability of pesticide regi strants. Would those who adopt the WDL approach be more vulnerable to tort litigation if us ers do not comply with requirements to obtain labeling? Conversel y, would registrants who opt out of the WDL process be more vulnerable to tort litigation fo r failure to employ technology that could better inform customers how to use products safely and effectively?

August 5, 2009 5 of 12 PPDC Discussion Paper2. Enforcement liability questions There are questions abou t how FIFRA enforcement might change under a WDL system, including who would be responsib le if the WDL downloaded from a website is incorrect and whether a product is registered in a given state. This may concern some registrants because they are li kely to be held responsible to ensure that all WDL labeling is correct. Ho wever, registrants also have this responsibility with hard-c opy labeling, so the issue may be with information technology rather than regulation.

3. Gaining acceptance by dealers and users Although the current system of hard-copy pesticide labeling is imperfect, most pesticide dealers and users understand it. With any significant change, there may

be those that resist the ch ange and voice their concerns. Discomfort with change and technology may push some customers a nd dealers toward products with hardcopy labeling, at least initially. Outreach and educa tion targeted to both pesticide users and dealers may reduce the concer ns expressed if WDL is implemented.

4. Increased standardization of labeling format Implementation of WDL may lead to pre ssure for increased standardization of how labeling is formatted. Some registra nts may view any increased uniformity as a limitation on their creativity.

5. Customer Acceptance The transition from hard-copy container labeling to WDL will require a significant amount of education of the regulated community. Not all pesticide users may be comfortable with this change , especially if they are unaware of the concept until it is implemented. In order fo r registrants to realize the full benefits of WDL, they would need to ensure that their customers are aware of and willing to accept the transition.

Pesticide Dealers/Retailers

a. Benefits

1. Greater customer understanding of product labeling How many times does a dealer get a ques tion from customers on how to safely, effectively, and legally use a product that they have purchased or intend to purchase? With streamlined WDL, the us e directions would be site-specific and may include application-specific instruct ions. This should increase customer understanding and reduce the number of questions to dealers on labeling interpretation.

2. Capitalizing on customer service People who apply pesticides as part of thei r business rarely go to a dealer and read the labeling in the dealer establishment. Therefore, they will continue to depend on dealers, agronomists, and other parties for expertise and assistance in making

August 5, 2009 6 of 12 PPDC Discussion Paperproduct choices. WDL would allow for a direct connection between the dealer and the applicator that is purchasing th e product. Some customers may also ask dealers to access and print WDL. This sales and communication opportunity could increase customer loyalty to dealers who offer these services.

b. Challenges & unresolved issues

1. Increased demand for customer service There will almost certainly be requests from customers for dealers to access and download WDL for their purchases. While some retailers may view increased customer service as an opportunity to gain sales and customers, others could view it as a burden. Some retailers may also need to train their employees to better serve customers and deal with technology.

2. IT investments & Lack of high-speed Internet access Some dealers may not have computers or high-speed Internet access. Many parts of the U.S. still lack high -speed Internet access, and dealers and farmers in those areas continue to rely on di al-up modems for Internet ac cess. If they choose to download and print WDL as a service to their customers, those dealers will need to make technology upgrades and budget th eir services accordingly. Dealers may also build relationships with libraries , coffee houses, and other locations that already offer Wi-Fi and other techno logies to access the Internet.

3. Liability questions Some have raised questions as to whet her dealers would have any responsibility to ensure that the purchaser of a prod uct accesses the WDL, and whether dealers incur any liability if they access incorrect WDL on behalf of a customer. EPA’s enforcement issue paper makes it clear that it is the ultimate responsibility of the pesticide user to obtain and comply with the correct version of the WDL. Such a regulatory position should adequately addre ss the liability concer ns voiced to date by dealers, although this issue contin ues to generate further discussion.

Farm Workers and Worker Advocacy Groups

a. Benefits

1. Better risk mitigation As already discussed, two benefits of WDL would be the availability of a streamlined container label, and the ability of the WDL system to provide shorter, site-specific labeling. The first would allow employers and employees to find those sections of the container label that address worker safety, such as first aid, emergency contact information, personal protective equipment, and re-entry intervals. The shorter, site-specific labeling would also increase the likelihood

August 5, 2009 7 of 12 PPDC Discussion Paperthat pesticide users will read and comply with the labeling requirements, thereby improving risk mitigation.

2. Better communication with non-English-speaking workers Use of technology would make it possible to better communicate to non-Englishspeaking workers or those persons with low levels of literacy. While the container labeling will direct users to Inte rnet sites with enfo rceable labeling, the WDL system could also incorporate li nks to Internet sites with product stewardship information. These websites could use streaming video, pictures, and other methods to better convey how to safely use and handl e pesticides. If resources have been translated, they coul d also be made available in languages other than English.

b. Challenges & unresolved issues

1. Lack of high-speed Internet access High-speed Internet access, or any Internet access for that matter, is not accessible for some farm workers, especially migrant workers. Therefore, some workers may not be able to directly access WDL because full container labeling would not be available. However, safety-related info rmation would be on the label affixed to

the container.

2. Limited scope of the WDL system Participation in the WDL system would be voluntary and advocacy groups may have interest in products that are not part of the WDL system. Although the WDL system might not meet all of the need s of advocacy groups, that instituting a WDL system would not decrease the amount of information available.

State & Tribal Pesticide Regulators

a. Benefits

1. Better user compliance & risk mitigation A fundamental tenet of pesticide regulation is the belief that a pesticide will not

cause unreasonable adverse eff ects to human health or the environment as long as it is used according to th e labeling. However, pesticid e labeling can be long and difficult to read, and anecdotal informati on suggests that some pesticide users do not fully read the labeling for that reason. WDL could be used to deliver streamlined labeling for users, thereby replacing 50-page multi-crop labeling with site-specific labeling that is only a few pa ges. This should increase the number of pesticide users reading, and therefore complying with, the pesticide labeling.

2. Faster implementation of new labeling requirements Many times, new labeling restrictions are implemented to better mitigate risk or to add newly-registered uses. However, it can sometimes take months or years for re-labeled pesticide products to reach the ch annels of trade and th e hands of users.

August 5, 2009 8 of 12 PPDC Discussion PaperWDL could be used to get revised labeling in the channels of trade sooner. This is especially beneficial for market entry of reduced-risk uses and products.

3. Reduction in multiple versions of labeling in the marketplace With the current system of hard-copy labe ling, there is often a significant lag time in re-labeling containers as newly-labeled containers gradually replace existing

containers in the channels of trade. During this interim period, there are multiple versions of product labeling in the channels of trade. The multiplicity of versions of product labeling also occurs as a consequence of the practice using supplemental labeling to allow for the lega l use of newly registered uses. This proliferation of labeling can create conf usion among pesticide users. It can also cause regulatory challenges because it is difficult to verify what version of a product’s labeling a user had in their po ssession during use. For participating products, the WDL system would largely e liminate multiple versions of labeling

in the channels of trade and th e use of supplemental labeling.

4. Easier verification of compliance with state-registered labeling All states have a state pesticide re gistration program, making it illegal to distribute or sell (and, in some states, to use) a product that is not registered in the state. This involves a state reviewing la beling. However, this labeling can vary greatly among states, either because some state-specific language may appear only in the relevant state or because of other voluntary differences in labeling by registrants based on market forces. In ma ny states, a product can be deemed to be

misbranded under state law if it bears labeli ng other than what has been registered by the state. Under the current system of hard-copy labeling, it is difficult or impossible for state regulators to verify whether the applicator is using labeling that matches approved by the state. By using technology available to compare different versions of similar electronic files, WDL should make this verification

much easier.

5. Increased standardization of labeling format Although federal regulations re quire all pesticide labeling to have certain sections, there are generally few requirements for the location or order in which those sections appear in labeling. Furthermore, related restri ctions and precautions can be found throughout a product’s labeling in different sections. This lack of

standardization can make review difficu lt. A parallel project to WDL is the electronic submission of pe sticide labeling for pesticide registrations. The electronic submission process and web-pr oduced WDL may be facilitated through the use of structured pro duct labeling and increased st andardization of labeling

format.

August 5, 2009 9 of 12 PPDC Discussion Paperb. Challenges & unresolved issues

1. Lack of Internet acce ss for State inspectors Some agencies do not have Internet acce ss for field inspectors. In order for WDL to be of most utility to regulators, St ate inspectors should be able to access the website in the field to compare the state- registered version of labeling with the version in the possession of the applicator.

2. Defining appropriate labe ling formats “in possession” With hard-copy labeling, regulators can usually verify labeling compliance during use inspections by simply referring to the labeling accompanying a product container (if the container is available) . However, with WDL, the labeling would not be physically attached to the container. Because of this, most regulators agree that there should be a requirement for th e user of a product with WDL to have a copy of the labeling in their possession dur ing use. While some states may allow the labeling in the possession of the user to be in an electronic format, other states may want the labeling to be in hard -copy format. This may cause confusion among users, especially those that make a pplications in more than one state.

3. Conflicts with state-specific laws or regulations Some states may have stat utory or regulatory requirements that address the distribution of pesticide la beling, including the allowed formats for labeling being

distributed. Distribution of web-based labeling may conflict with the laws and regulations in some states. If EPA es tablishes a WDL system, the effect of FIFRA sec. 24(b) – which prohibits states from “impos[ing] or continu[ing] in effect any requirements for labeling . . . different from those required under [FIFRA]” – on any such provision s would need to be evaluated.

US Environmental Protection Agency

a. Benefits

1. Improved protection of public health and the environment Product labeling is the primary mechanis m used by EPA to communicate critical information to the pesticide user. The la beling contains use di rections, health and safety information, and instructions fo r proper storage and disposal. Improved comprehension of and compliance with la beling and faster re alization of risk mitigation measures in the field, expected benefits of web distributed labeling, would improve protection of huma n health and the environment.

2. Improved labeling comprehension & compliance A fundamental tenet of pesticide regulation is the belief that a pesticide will not

cause unreasonable adverse eff ects to human health or the environment as long as it is used according to th e labeling. However, pesticid e products’ labeling can be long and difficult to read, and anecdotal information suggests that many pesticide users do not fully read the labeling for th at reason. WDL can be used to deliver streamlined labeling for users, thereby replacing 50-page la beling with labeling

August 5, 2009 10 of 12 PPDC Discussion Paperthat is only a few pages. The shorter web-distributed labeling would be targeted to the state and target site of the appl ication, providing only the relevant required elements of labeling. Streamlined, simplif ied labeling should result in a greater likelihood of pesticide users reading a nd understanding, and therefore complying with, the pesticide labeling.

3. Faster implementation of new labeling requirements The web-distributed labeling system has th e potential to dram atically accelerate the speed with which new labeling requireme nts to protect public health and the

environment could take effect. Rather th an waiting for paper labeling to work its way through the printing and distribution processes, the new requirements could appear in labeling downloaded from the we bsite within a week or even a day or two after EPA approval. Users who purch ased products after the changes were posted on the website would find the new requirements in the labeling they downloaded. Thus, like the current syst em the new requirements would apply prospectively, to products purchased after the date of EPA’s decision. Unlike the current system, it would implement changes much sooner after EPA concluded they were needed. Faster implementation of risk mitigation measures and registration of reduced-risk products coul d improve the overall safety of public

health and the environment.

b. Challenges & unresolved issues

1. Need for culture change The transition from hard-copy contai ner labeling to WDL would require a significant amount of education of stakeholders throughout the regulated community. Not all people will be comfor table with this change, especially if they are unaware of the c oncept until it is implemented. Stakeholder outreach is

critical to the refinement of web-distributed labeling; feedback and support from registrants, users, dealers, educators, state regulators, and environmental groups, and others is necessary to ensure that the concept can be successful. Once

stakeholders are comfortable with the c oncept, broad outreach to all potentially affected parties will occur. Implementa tion of a web-distributed labeling system will include sufficient time to transition from the traditional paper-based system, allowing regulators, extension personne l, and others to educate the public.

2. Ensuring a level playing field Web-distributed labeling has the potential to benefit registrants who elect to participate in such a system. Alt hough some registrants may elect not to participate in web-distributed labeling, ot hers may not have the capability. EPA

must be sensitive to the concerns of those who cannot participate during the development of the web-distributed labeli ng system and should ensure that the web-distributed labeling system is availa ble to all potential stakeholders.

3. Conflicts with state-specific laws or regulations

August 5, 2009 11 of 12 PPDC Discussion PaperSome states may have stat utory or regulatory requirements that address the distribution of pesticide la beling, including the allowed formats for labeling being

distributed. Distribution of web-based labeling may conflict with the laws and regulations in some states. If EPA es tablishes a WDL system, the effect of FIFRA sec. 24(b) – which prohibits states from “impos[ing] or continu[ing] in effect any requirements for labeling . . . different from those required under [FIFRA]” – on any such provision s would need to be evaluated.

4. Definition of ‘production” and re gistration of establishments EPA regulations for the registration of es tablishments require that an operator must register his establishment if he e ngages in “production” of a pesticide.

“Production” is described to include re-labeling a pesticid e. EPA needs to clarify that the action of downloading WDL doe s not constitute “production” of a pesticide.

5. EPA Internet Access Generally, the private sector adopts de veloping technology faster than EPA. Implementing WDL would require signifi cant technological a dvances, including building a database for state-registered labeling, hosting a we bsite/portal, and including security controls to maintain the integrity of labeling. If EPA is required to build and maintain the WD L system, adoption could take longer.

Summary Although significant questions sti ll remain, the potential benef its and challenges of WDL for regulators, pesticide users, regi strants, and other stakeholders must be considered. Other benefits and challenges will likely be identifi ed as the development of a WDL system moves

forward.

August 5, 2009 12 of 12 PPDC Discussion Paper