Web-Distribution of Labeling Wo rk Group Discussion P a per: Scope of Web-Distributed Labelin g ISSUES : EPA is working to establish a system whereby purchasers andusers m a y obtain a legally valid copy of the labeling for a pesticide product from a website or toll-free telephone service. This paper explores the scope of this system and also the scope of a pilot project. The following issues are discussed: 1] W h ich products should be included? 2] Should the system be m a ndatory or voluntary? 3] Are there additional criteria that needto be considered for the pilot project? BACKGROUND : Legal Framework As defined in FIFRA §2(p)(2), “labeling” is “written, printed, or graphic m a tter—(A) accomp anying the pes ticide or dev i ce at any time; or (B) to which reference is m a de on the lab e l or in literatu re accomp anying the pesticide o r devi ce. . . .” Labeling typically includes extens ive “directions for use” and contains provisions regarding the use of a pesticide that are d e signed to ensure th at its use does n o t cause un reas onable adverse effects on the environm ent. Products Under the current system, pestic ide users receiv e the labeling with the product. The labeling m a y be phys ically attach ed to the co ntainer or it m a y be in accomp anying literature. The proposed system would require user s to obtain som e of the labeli ng, such as the directions for use, from a website or by calling a toll-free te lephone num ber. The Agency believes that users of certain products m a y be better equipped to obtain the labeling from these sources. For users of other products, it m a y too burdensom e to re quire them to obtain th e labeling, and therefore unreasonab l e advers e effects m a y occur if the lab e ling isn’t obtained and followed. Therefore, the discussion describes which products are appr opria te to in clude in a web-based distribution system

. Mandatory vs. Voluntary The current system requires all labeling to be attached to the product cont ainer or to accomp any the pesticide or device. W ith web-based distribution of labeli ng, the labeling m a y not physically accomp any the product. The system could be m a nda tory, req u iring all regi strants of the products approved for the system to use web-distribut ed labeling, or it coul d be voluntary, allowing registrants to decide whether or not to use the system

. This disc ussion describes the implications of a m a ndatory versus a voluntary system

.
Septem ber 17, 2008 Page 1 of 10Pilot Pro j ec t It is expected that the pilot project will follo w the scope of the proposed system

. However, additional restrictions or require m e nts m a y be ne eded to properly evaluate web-distribution of labeling. In addition, sin ce the p ilot will occu r earl y in the education p r o cess that will require a signif i can t c u ltur e chang e in the regu lated commun ity, it is possible that additional restrictions m a y be needed, or a lim ited scope required, in or der for an effective, sa fe and non-disruptive test of the new system

. DISCUSSI ON :

A. Which products should be included?
Registration as defined in the statute

. Under Section 3 of FIFRA, pestic ide products must be registered by the Agency before they m a y be distributed or sold. S p ecific types of products defined in the statute are described below. General Use products and unclassified products m a y be sold to and used by anyone, with som e limited exceptions (e.g., termiticid e p r oducts hav e labeling that res tricts u s e to only tho s e applicators licensed by the state). G e neral use pr oducts, when used according to the label, are generally considered not to cause unreasonable adverse effects on the env i ronm ent. The concern with web distribution of labeli ng is th at adverse ef fects m a y oc cur if users do not obtain and follow the labeling. Since general use products include products us ed in a variety of settings, including agricultural, re sidential, and industrial, som e user s m a y be more likely to obtain the labeling tha n others. Th is will b e de scribed in th e section Marketing Sectors. In gene ral, the Agency believes that general use products and unclassified products are appropriate f o r webdistributed labeling. Restricted U s e Products (RUPs ) m a y only be sold to and used by a certified applicator or under the direct supervision of a certified applicator. T h is is due to the conce r n that these pe stic ides m a y cause unreasonab l e adverse effects on th e en vi ronm ent unless applicators have training that, in effect, supplem ents label pre cautions. Since RUPs are consider ed m o re risky than general use products, there m a y be som e reluctance to allo w these products to be sold without the full labeling attached or accompanyi ng the product. However, certifie d applicators receive training and/or mu st pass an exam in order to be certifie d. These applicators are m o re likely to receive appropriate training and m a y be more likely to obtain the labeling from the website or through the toll-free telephone num b er. The Agency believ es that web-distribution of labeling should be feasible for restricted use products, particularly if applicators can rece ive training on using webdistributed labeling during th e certification training. Section 5 of FIFRA allows appli cants to obtain E xperim e ntal Use Permits (EUPs) for pesticides that have not been registered in order to obtai n data needed fo r a Section 3 registration. One

Septem ber 17, 2008 Page 2 of 10concern is that the pesticide is not registered so the risks m a y not be known. In addition, the EUP registrations already have limited lifespans and there are only a sm all num ber of users. Since the ap plican t, researchers, or o ther us ers involved with resear ch will receive the appropriate labeling, there is little benefit to including these products. Section 18 allows federal or st ate agencies to obtain em ergenc y exemptions for the use of pesticides not registered under Section 3. These pe sticides m a y or m a y not be registered for use on other sites. Em ergency exemptions m a y be gran ted to control a public h ealth pest, to treat a quarantine pest, or, if certain docum entation crite ria are m e t, to prevent economi c loss due to a pest. 40 CFR § 166.7(a) is flexible in the way us ers are notified about the em ergency exemption. The State or Federal Agency m a y distribute in a variety of ways, and som e may already use the internet. In addition, labeling does not appear to be required, as th e regulations allow the State or Federal Agency to distribute copies of the approval letter or othe r information. However, it is possible that som e states requi re labeling to be distributed. Web-distributed labeling would benefit users of the pesticides prov id ed thr ough an em ergency exemption because they m a y be able to obtain the labeling, when required, m o re quickly and readily. Users of these pesticides m a y be state or federal agencies (in the case of public health or quarantine pests) or m a y be agricultural growers who ha ve an economi c interest in controlli ng the pest. It is expected that users of pro ducts gran ted through em ergency ex emption will be ab le to obtain the labeling through the website or through the to ll-free number. If the toll-fr ee number is used, however, the Agency should ensure that the labeling can get to the user quickly enough so that users can adequately control the pest. In addition, the labels for products granted an em ergency exemption tend to be for a specific crop/pest combination and so m a y be less burdensom e to download than longer pesticide labels.
States m a y register additional uses for special local needs for their stat e through Section 24(c). These labels tend to be f o r a specif ic site or set of s ites and thus m a y not be as long as section 3 labels. The process is different for 24(c) registrations (i.e., th e state appro v es a use an d the Agency reviews it after the fact ). 40 CFR § 162.153(e)(4) requires states to ensure that the supplem ental labeling is available within 45 days of approval. Som e states m a y already m ake the lab e ls av ailab l e on th eir websites. W e b dist ribution of labeling m a y make it m o re feasible for 24(c) labels to be provided on the web fo r all states. Depending on the website design and search features, this m a y benefit tribes or others who m a y try to de te rm ine which 24( c)s ar e available in the states. All of the registration types a nd products described in the st atute could be eligible for participation in web distributed labeling. Howeve r, there are som e concerns and no benefits to includ ing Se ction 5 EUPs so this g r o up will not b e includ ed. Registrant O p tions Registrants m a y sell their products using all the EPA-approved labeling for the registered product or f o r a subset of the uses that were regi stered. The registrant m a y also choose to have another company or entity sell the products. These products are supplemental distributor products. T h ey mu st be the sam e as the regi stered product, although certain labeling elem ents,

Septem ber 17, 2008 Page 3 of 10such as the nam e of the product, m a y be different. In add itio n, som e label claim s and sites m a y be deleted from the supplem en tal distributor labeling. Both types o f products can be accomm odated in a web distributed lab e ling system

. For supplem ental distributor products , the product mu st m eet the cr iteria for such products. However, for m arketing reasons, the registrant may not want s upplem ental distributor products to be part of web distributed labeling. Ther efore, under a voluntary system , the inclusion of supplem ental distributor products m a y be deci ded in the individual agreements between registrants and supplem ental distributors. Includi ng supplem ental distributor labels m a y be m o re f

easible if the regis tr a nts host the web s ite. Oth e rwise, the Ag ency m a y experien ce a re source burden, depending on the process developed, if supplem ental distributor product labels are submitted to the Agency. Marketing S ectors Products m a y be m arketed for specif i c types of uses

. Som e of these uses are described below. While web distributed labeling is appropriate for som e of these products, it m a y not be for other types. Agricultural commoditie s are defined in 40 CFR § 171.2 as “any plant, or part thereof , or anim al, or anim al product, produced by a person (i ncluding farm ers, ranchers, vineyardists, plant propagators, Christm a s tree growers, aquaculturists, floriculturists, orchardists, foresters, or other comp arable persons) prim ar ily for sale, consumption, propagation, or other use by m a n or anim als.” Pestic ides us edin an agri cu ltur a l se tting are used as part of a business. Since agricultural comm odities are ofte n grown in rural areas, there is concern that these areas m a y not have internet access, or that access is not adequate to download labeling. However, fax m achines m a y be an option for obt aining labeling, or the users m a y have dealers that m a y be able to provide labeling. In a ddition, agricultural producer s m a y plan ahead and purchase pesticides before the growing season, giving them a d equate time to obtain labeling. The Agency believ e s thatweb-dis tri b u ted lab e lin g is appropriate for agricultural producers, even though there are concern s about adeq uate t echnology, since th ey shoul d be able to access labeling. Pesticide use f o r these users is likely to be an important aspe ct of their business so these use r s h a ve an inc e n tive to f o llo w the labe ling direc tion s . Professional non-agricultural products have not previously been defined by the Agency. EPA has a draft definition of a “pro fessio n al specialty pesticide”: A registered pesticide product labeled only for pe st control f o r: (1) turf (includes sports turf and golf courses), lawn, or ornam e ntals; (2) nursery or greenhouses; (3) structures and institutions (hum an dwellings both public and private, schools, food handling estab lishm ents and th eir adjacen t areas); (4) aqu a tic veg e tatio n m a nagem e nt; (5 ) right-ofways; (6) forestry; and (7) publ ic health (m osquitoes, ticks, and other carriers or transm itte rs of inf ections , disease o rhum a n aller g ens); with the exceptionof pesticid e products that are: (1) used in the producti on of an agricultural commodity; (2) labeled only for use in or around a household or resi dence by a resident; (3) industrial biocides; or (4) antim icrobials used in swimm i ng pools.”

Septem ber 17, 2008 Page 4 of 10For the purposes of web-distributed labeling, pr ofessional non-agricultura l products have been described as products used in a m o ney-m aking orbusiness operation, either as part of the business (e. g., contro l weeds in rights of ways) or because pesticide app l i cation s are a necessary component of the business (e.g., to control pests in food handling establishm ents), or as a public regulatory f unction (e.g., m o squito control, invasive pest m a nagem e nt). In order to mi nimi ze confusion over this issue, it is recommended that the definition proposed for professional specialty products apply to professional non-ag ricultural products, withthe exception that industrial biocide and possibly an timicrobials used in swimmi ng pools should also be included in the definitio n. These ad dition a l pro ducts (indus trial bio c ides and possib l y antim i crobials us ed in swimming pools) m a y also be appropriat e for web distribution of labeling. The Agency believes that, as with agricultura l products, prof essional non-agricultural products are used in a business or regulat ory setting and thus web distribu tion of labeling is appropriate for these products. These products are used by i ndividuals who use pestic ides in their business or prof essio n and are f a m iliar with r e gulato r y re quirem e nts. It is also in the bes tinte rest of thes e users to use the products correc tly. In addition, EPA has estab lished m e thods for communicating with these user groups. According to 40 CFR § 150.3 “r esid entia l use means use of pesticide di rectly: (1) on hum a ns or pets, (2 ) in, on, or aroun d any structure, vehicle, article, surface, or area associated w ith th e household, including but not limited to areas su ch as non-agricultural outbuildings, noncommercial greenhouses, pleasure boat s and recreational vehicles, or (3) in any preschool or day care facility. ” Web-distribution of labeling m a y not be appropriate for products registered for general use in residen t ial s e ttings because access to the in ternetm a y be limited for mu ch of the general pub lic. In addition, it m a y be more difficult to communi cate and train the general public about obtaining the lab e ling via the webs ite comp are dto users w ho use pesticides as part of their business and thus comp liance with labels could be dim i nish ed. These users are also less inform e dabout regulatory requirem e nts. Som e professional applicators m a y apply residential products as part of their business. For webdistribution of labeling, the Agency is concerned with the user of the product rather than the particular use sites registered. However, there is not always a clear wa y to distinguish whether residen t ial u s e products will be us ed by a profe ssional or a ho m e owner. The Agency does not believe that products used by the general public, su ch as residential use products, are appropriate for web distribution of labeling.
Som e products m a y be m arketed for both the agri cultural or professional non-agricultural sector, as well as th e resid e ntial sector. It w ould be important for the registrant to m ake sure that products intended for the resident ial sector include all inform a tion on the attached label. Other 40 CFR § 150.3 defines end use product a s “ape s t ic i d e pr oduc t whose labeling (1) includes directions for use of the product (as distributed or sold, or afte r com b ination by the user with

Septem ber 17, 2008 Page 5 of 10other substances) for co ntrolling pests or defo liating, desiccating, or regu lating the gro w th of plants, and (2) does not state th at the product m a y be used to m a nufacture or formulate other pesticide products. Manufacturing use products (MUPs), as defined in 40 CFR § 150.3, “m eans any pesticide product that is not an end-use product.” Th ese products m a y be used to m a nufacture other pesticide products.
Formulated end use products are generally the type s of products that have been described in the above sections. Since MUPs are used in the pesticide industry, these produc ts could be eligible for web-distribution of labeling but it is not cle ar if there is a ny value to including them. Since the labels tend to be shorter than end use pr oducts and changes m a y not occur as frequently, registrants m a y choose not use we b-distributed labeling due to the limited benefits for these products. The Agency would appreciate industry feedback as to whether there is benefit by including MUPs. Another scope related issue is whether the produ cts included in the system should be lim ited to contain e rs o f a certain size. One common size fo r commercial products is 2 1⁄2 gallons. Limiting web distribution of labeling to large c ontaine rs may lim it pro ducts witho u t the f u ll labeling atta ched to the conta i ner f

r om gettin g into th e ha nds of consum ers. Overall Pro duct Recomm endation Products that are defined in the statute, with th e exception of Section 5 E U Ps, should be included in the web distribution of labeling system

. Th e system should be limited to products that are used f o r commercial, pr of essional o r regulato r y uses, inc l uding agricu ltu re. The Age n cy will consider use site limitations on the labeling, cl early identifiable professional uses, possibly container size limitations, and the label use dire ctions when determ ining whether a product is intended for commercial or consum er use. B. Should the system b e mandatory or voluntary? Voluntary Under a voluntary system, registrants would decide whether or not to pa rticipate, andpossibly which products would be included. One concern with a voluntary system is that prod ucts m a y be sold under two different system s. W ith the current sys t em , users can u s e the produ ctacco rding to the lab e lin g that accompanies the product un til the pesticid e is used up. Under the p r oposed sys t em , labeling will have a limited lifespan from the date of download, after which us ers will need to re- download the labeling to continue using the product. The concern is thatthis could put som e products at a disadvantage if they are used for similar situations but one ha s labeling that m a y expire within a c e rtain tim e period and the other can be used indefinitely. In addition, following the rules for two system s could be confusing to users and dealers. Another concern with a voluntary sy stem is that som e of the bene fits of web-distributed labeling would be los t

. For example, one ben e fit is that any new precautionary la nguage will get in to the

Septem ber 17, 2008 Page 6 of 10hands of users m o re quickly. If only som e pr oducts are using the web distribution of labeling system , then the benef it will not b e a s substan tia l since o ther similar prod ucts would h a ve labeling that is valid indefinitely. In addition, it would be more difficult to m ake the case that changes in label statem ents coul d be m a de across all products at the sam e tim e, allowing for a level playing field. Mandatory The Agency could also choose to m ake web di stributed labeling a m a ndatory program

. This would ensure that only one system is being used, at least within a category of products. However, this would require rulem aking, which m a y delay the process. In addition, it m a y be difficult for the Agency to logistically get the sy stem up and running for all users at one tim e. It m a y also cause financial and logis tical strain to registrants or other comp anies in the pesticide industry that do not have the infrastructure to use web-based distributi on of labeling for their products. Voluntary vs. Mandatory Recomme ndation There are issues with both a voluntary and a m a nd atory system. The recommendation is to have voluntar y sy stem , at leas t initia lly. T h is will eas e the burden on regis tran t s and will allow users to transition to the new system

. C. Are there additional crit eria that need to be cons idered for the pilot project? A pilot project is planned for 2009. W ith the pilot, the Agency would like to determine: how well the d i stribution sys t em works; user acceptan ce of the dis tribu tion sy s t em ; whether there are comp liance problem s due to the new system ; how the state synchronization issue is worked out; and how the lim ited lifes pan label is accepted. Two possible projects have been proposed for the p ilo t. This f i rst is to distribu te sup p lem e ntal labeling for new uses via the webs ite and/or through the fax num b er system. The second is to do a sm all scale version of the system , incorporatin g container label changes, labeling available on the website and/or through fax, a nd possibly a searchable database . The sections below describe in m o re detail th e two proposed pilo t projects , pros and cons for each project, recommended criteria, and issues that n eed to be res o lved before the pilot. T h e issues will be fully discussed in separate issue papers. Supplem ental Labeling Pilot The proposed supplem ental labeling pilot is intend ed to distribute labels f o r supplem ental uses via the web. These products alr eady have registered uses and so only the label for the new use would be distributed. The labeli ng w ould likely be available to us ers as a PDF. The container could be stickered to aler t users to th e website.
Pros:
• Allows the Agency to evaluate whether user s will go to th e website to ge t the lab e ling
• Sm all in sca l e

Septem ber 17, 2008 Page 7 of 10• Labels are short so would not be as burdensom e to print
• System could probably be set up by 2009
Cons:
• Does not test the web distribution of labeling system as envisioned by the workgroup o May also confuse users as to the vi sion for web distribution of labeling
• Users of ten obtain supp lem e ntal labe ling f r om the inte rnet so will only le galiz e a pra c tice that is alread y occurring Issues that need to be resolved:
• State synchronicity
• Labeling lifespan
• Need to articulate production issue
• Need to create website/fax syst em and resolve web hosting issue
• Culture change – how to get participation
• Determ ine how to colle c tdata and h o w to assess the pilot Dynami c labeling p ilot The proposed dynami c labeling pilot would be a sm aller scale of the prop osed web distributed system

. The product container label would only c ontain those elem ents c onsidered essential on the lab e l ( e ither requ ired by statu t e or regulations or as need edfor safety) and a referen ce to th e website. The rest of the labeli ng would be available on an intera ctive website or by fax. Use of a long lab e l, with the ab ility to obtaina subset of the label, would dem onstrate on e ben e fit of the system

. Pros:
• Allows the Agency to evaluate the proposed system
• Would allo w users to give accurate f eedback on the proposed system since they m a y have experience with it
Cons:
• May not be feasible for 2009 due to additional technical and polic y issues that need to be resolved
• May require user to print the whole label, wh ich could be burdensom e, if the website is not searchable by site Issues that need to be resolved:
• All of the issues described for the propos ed supplem e ntal labeling pilot, PLUS
• Container label vs. labeling from website
• Am ended regulations and/or MOUs th at allow re gistr a nt to d o pilot
• Are ther e ad dition a l enf o rcem ent considera tion s ?
• Need to develop website with additional capabilities (e.g., searching for crop site function)
• Need to develop coding system

Septem ber 17, 2008 Page 8 of 10Since this approach m a y not be fully functioni ng for the 2009 use season, a dem onstration to be used in education and outreach m a y be possibl e and could provide an opportunity for initial feedback from potential users. Criteria for Either Pilot The num ber of products and num ber of comp anie s involved should be limited. However, the num b er should be large enough to accurately evalua te the sys t em . Li miting the pilot to one or two comp anies but inclu d ing several products fr o meach company m a y be a way to keep the pilot simp le but to still have enough products out on the m arket to evaluate the system. Registrants that already have a good network or outreach on thei r products m a y be better suited to the p ilot. There are tw o options for the types of products to include. If products thatare considered lower risk by the Agency are used, risks m a y be mi ni mi zed if us ers do not obtain the labeling. However, if RUPs are used, then the applicators have been trained and/or certified and m a y be more likely to obtain and follow the labeling. The pilot should focus on commercial products. Section 3 products and not section 18s and 24(c)s should be used. Section 18 and section 24 (c) products already have an estab lish e d system for distribution and including them in the pilot wo uld have little benefit and could confuse users as to the purpose of the pilot. For the pilot, the Agency m a y want to target a subset of sectors (e.g., a certain geographical area and/or a certain sector of agricultural users). In order to mi ni m i ze the risk of users applying the product without readi ng the label, the uses from the previous season should not be changed on the label fo r the pilot. The pilot should be voluntary. A state shou ld be willing to participate in the p ilo t. If a state is willing to cooperate, iss u es of state synchronicity m a y be easier to handle.
RECOMME NDATION: The scope of web distributed labeling system s hould include all of the registered products described in the statute, except for Section 5 EUPs , as well a s the reg i stra nt options described in this paper. The system should be limited to pr oducts that are used for comm ercial, professional or regulatory uses, including agriculture. Re sidential products should have the full labeling accomp anying the produ ct container. However, in addition, registrants may choose to post the labeling for residential products to the website so that consumers m a y obtain som e of t h e benef its of web distri bu ted lab e ling, such as vie w ing text in a larg er f ont size. The A g ency will consider use site limitations on the labeling, cl early identifiable professional uses, possibly

Septem ber 17, 2008 Page 9 of 10container size limitations, and the label use dire ctions when determ ining whether a product is intended for commercial or consum er use. The system should be voluntary, at least initially. Once it is established, the Agency m a y want to reevaluate and decide if a m a ndatory system is appropriate. The scope of the pilot should be narrower than the fully functioning system. It is suggested that the comp anies involved, the num ber of products , the geographic region, and the sector be lim ited. It is expected tha tthe p ilot will be exp a nd ed in f u ture years bef o re the f i nal sy s t em is imple m ented.

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