Web-Distribution of Labeling Wo rk Group Discussion Paper Lifespan of Web-Di stributed Labeling

ISSUES :

Assuming that EPA establishes a system whereby purchasers and users may obtain a legally valid copy of the labeling for a pesticide product from a website or toll-free telephone service,

1] should such labeling have an expira tion date that definitively limits its “lifespan”?

2] if so, how long should the “lif espan” of such labeling last?

BAC KGROUND :

A. The Current System

Because FIFRA’s misuse provision in §12( a)(2)(G) makes it unlawful to “use a pesticide in a manner inconsistent with its labeling,” the labeling 1 for a pesticide product becomes the primary mechanism by which EPA communicates enforceable requirements to pesticide users abou t how to use a product safely and e ffectively. Under historical and current industry and regulatory practice, near ly all pesticide products are distributed with all labeling accompanying th e pesticide container. 2 Consequently, each time that a pesticide is used up and the c ontainer is disposed of, the us er must get a new container with new labeling that he ca nnot alter or deface. (FIFRA §12(a)(2)(A) makes it unlawful for a person to detach or alte r the labeling approved for a re gistered pesticide.) This means that the labeling accompanying the containe r is legally valid for as long as the user possesses the specific product cont ainer and is only valid with respect to quantity of pesticide originally in that container.

Under this system has one very importantadvantage: a person who purchases a pesticide can confidently expect to be able to use the pesticide according to the labeling accompanying the product until the all of th e pesticide has been used up, unless EPA takes regulatory action to prohibit use of the product. Although EPA has the legal authority under FIFRA §§ 6, 12(a)(2)(J), a nd 12(a)(2)(K) to is sue cancellation and suspension orders prohibiting the use of pestic ide stocks in the hands of end-users, it should be noted that the Agency has only imposed such prohibitions in very rare

1 As defined in FIFRA §2(p)(2), “labeling” is “wr itten, printed, or graphic matter—(A) accompanying the pesticide or device at any time; or (B) to which refe rence is made on the label or in literature accompanying the pesticide or device. . . .” Labeling typically includes extensive “directions for use” and contains provisions regarding the use of a pesticide that ar e designed to ensure that its use does not cause

unreasonable adverse effects on the environment.

2 Only a small number of pesticide container labels contain reference to materials – thereby making that material “labeling” – that do not accompany the pesticide product. For example, portable chlorine gas products labeled for use in “shooting” swimming pools refer to the application practices manual issued by

the Chlorine Institute.

February 27, 2009 1 of 9 PPDC Discussion Paper Draftcircumstances when EPA believed that the continued use of a pesticide posed an extraordinarily high risk to publ ic health or the environment. As a consequence, users have come to expect EPA will not take action that would make their planned use of the pesticide unlawful.

While anecdotal reports indicate most pe ople use up a pesticid e reasonably soon after they purchase it (i.e., w ithin 6 - 12 months after purchas e), this is not always the case. Sometimes a person may buy a product and not need to use it because, for example, the expected need to control a pest problem did not arise, and the product is kept in inventory until it is next needed – for agricultural products, commonly the growing season in the following year. A small percentage of pesticides are kept for even longer periods; chemical collection da ys indicate that some contai ners may be years, even decades, old. As far as EPA is concerned, therefore, the labeling of pesticide products effectively has an indefinite and potentially long lifespan – the amount of time that the user has possession of the pesticide contai ner which the labeling accompanies, which may vary significantly.

Because the current system creates no de finitive lifespan for pesticide labeling, there are ongoing problems with enforcement and existing stocks of pesticides. The major problem is that users do not have the be nefit of the most current directions about how to use a pesticide safely and effectively. Using the product according to old labeling may result in unnecessary risks to pub lic health or the environment.

Finally, the existing regulatory systemtypically involves significant delay

between an EPA decision to add new or re vised labeling provisi ons to protect public

health and the environment and the actual appearance of the labeling on products in the hands of pesticide users. Once EPA makes a regulatory decision and a registrant agrees (or is legally compelled) to revise existing product labeling, the registrant must develop a new version of the labeling and submit it to th e Agency for approval. Then, the registrant must print new labeling and ensure that the new labeling is attach ed to newly produced products. Although EPA may specify a shorter time period, the Agency typically allows the registrant 12 to 18 months to implemen t the labeling requirements on product newly released for shipment. 3 Quantities of a product bearing th e revised labeling must then be distributed through wholesale and retail distri bution networks before they finally reach

the user.

C. The Proposed System

EPA is considering a system that would establish a new way of making all of the labeling of a pesticide product av ailable to purchasers and user s. Instead of obtaining the labeling along with the pesticid e container at the time of product purchase, a purchaser or user would be required to obt ain a copy of the la beling either by downloading a file from a website or by calling a toll-free telephone service that would then mail or fax the labeling to the caller. Because the new syst em of obtaining labeling would depart from

3 Under the requirements at 40 CFR 152.130(c), registrant-initiated changes have to be incorporated within

18 months.

February 27, 2009 2 of 9 PPDC Discussion Paper Draftthe widely prevailing practice of associati ng labeling with a specific container (which physical association effectively establishes a li fespan for the validity of labeling), the new system raises questions about how EPA should design the system so that users obtain and follow a relatively current version of the labe ling for a pesticide th ey use repeatedly.

One premise of the new system is that labeling would not physically accompany the pesticide product at the time of sale. Instead, material would become “labeling”

because the container label w ould refer to it and make it le gally binding. Referenced labeling would be obtained separately from the product container. Once obtained, such labeling could be considered to “accompany” a product, but it does not necessarily accompany just a single specific container as has been and currently continues to be the case. Rather the customary physical associa tion of the labeling and a pesticide container is attenuated, and the downloaded labeli ng could legitimately “accompany” more than one container. (If a user possesses multiple co ntainers of the same pesticide product, it may not be necessary to require the user to obtain separate labeling for each discrete container of a pesticide he possesses.)

The attenuation of the labe ling and the product containe r creates an issue about whether the downloaded labeling may be associ ated with different containers obtained over time. If the labeling is not uniquely asso ciated with a container that the user empties and disposes of, the user in theory could continue to us e an old version of labeling indefinitely with multiple containers. But versions of labeling for a pesticide approved by EPA are expected to change over time. Taken to its logical extreme, a version of labeling obtained under the new system coul d, in theory, be used with any product container, unless there were a restriction that limited its applicability to specific containers or for a specific time period. Unless users must replace old labeling for a product with an updated version, any improve d protections for public health and the environment would not become applicable.

DISCUSSION :

The new approach is expected to acceler ate the time between an EPA decision to require new risk mitigation measures and the appearance of the new use directions or restrictions in labeling. Fo llowing an agreement with the registrant, the Agency could make the revisions in labeling posted on the we bsite, and users would be able to obtain the labeling for products already in the channels of trade. In that way users would get the new labeling sooner than if they had to wa it for the revised labeling to be printed and applied to the containers of newly produced pesticide that would then be distributed through wholesale and retail channels.

As indicated in the Background section above, however, the new approach of distributing labeling via the in ternet attenuates the physical connection between labeling and a single specific container. Such atte nuation means that, in the absence of any restriction, the labeling potenti ally could be used indefinitely with multiple pesticide containers and that changes in labeling desi gned to improve protection for public health and the environment might never be fully implemented. Thus, EPA believes any new

February 27, 2009 3 of 9 PPDC Discussion Paper Draftapproach to web-based distri bution of labeling needs to make a link between specific

containers and the web-distributed labeli ng in a way that avoids this problem.

A. Should There be a Definitive Life span for Web-Distributed Labeling?

The Agency sees at least two possible ways to address the issue of linking labeling to specific containers.

• First, EPA could require product containers to bear a statement that the specific container was “produced on [date]” and also require the user to obtain a version of the labeling approved on or after that date. This approach would essentially duplicate many characteristics of the existi ng system with its current advantages and disadvantages.

• Second, EPA could require that web-distri buted labeling have a defined lifespan,

after which the user would need to obtaina new, potentially updated version of the labeling. This approach would impose some costs on users, but it would have many advantages in terms of quicker, universal implementation of new risk mitigation measures.

Labeling linked to production date . The first approach would work as follows. Each pesticide container would bear a registration number and another “unique identifier” (possibly an alphabetical code) associated witha specific version of the container label for the product, as well as the date on which the product was “produced,”

e. g., the date on which the pesticide mixture was put into the labeled container. The container label would also require the user to obtain a copy of the labeling for the product from either a website or a toll-free telephone service. Finally the container label would specify that the product could be used only in accordance with a ve rsion of the labeling obtained after the production date from one of these sources.

The consequence of this first approach w ould be that the pesticide could lawfully be used according to any version of the labeli ng that existed after the date on which the product was produced. Once the pesticide in th e container was used up (or disposed of), if the user wanted an additional quantity of the pesticide, the user would need to obtain a new container of the pesticide labeled witha new “produced by [date].” Labeling that predated the production date on the newly obt ained quantity of pesticide would no longer be valid. In effect, this a pproach gives web-distributed labeling an indeterminate lifespan equal to the amount of time a user take s to use up the pesticide material.

Finite labeling lifespan . The second approach would work as follows. The label on a pesticide container would bear a registration number a nd another “unique identifier” associated with a specific version of the c ontainer label for the product, as well as a requirement that the user obtain a copy of the labeling for the product from either a website or a toll-free telephone service. When the user obtained a copy of the labeling, the labeling would bear an expiration date, after which the labeli ng would no longer be valid. The lifespan would be of a fixed length – for example, 6, 9, or 12 months (or

February 27, 2009 4 of 9 PPDC Discussion Paper Draftlonger) – and would be calculated from the da te of the downloading / printing of the labeling. For example, if the labeling lif espan were 12 months, labeling downloaded from the website on March 12, 2009, would be valid through March 11, 2010. (Note: the expiration date would not affect the validity of the registration or the validity of any tolerances or tolerance exemptions.) Als o, an expiration date for downloaded labeling would be independent of any statement about the time period for which the product could reliably be stored without any adverse ch anges in the composition of the formulation.

Under this second approach the pesticide could lawfully be used according to the downloaded labeling only for the lifespan of the labeling. Consequently, if a user thought he might still possess some quantity of the pest icide after the lifespan of his version of the labeling had expired, he would need to obtain a newer vers ion of the labeling with a lifespan running until a later expiration date. Of course, the labe ling available for the product could change between the user’s dow nloads. For example, EPA might have approved additional uses, and if so, those uses would be reflected in the new labeling and the user could then lawfully apply the produc t on new sites. Similarly, EPA might have approved new labeling to mitigate potential risk s. In either case, the user would be required to comply with all directions and re strictions on the subsequent version of the labeling.

Among other things, the web-distributed labeling system would dramatically accelerate the speed with which new labeling requirements 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 distri bution processes, the new re quirements could appear in labeling downloaded from the website withina week or even a day or two after EPA approval. Users who purchased products af ter the changes were posted on the website would find the new requirements in the labe ling they downloaded. Thus, like the current system the new requirements would apply pros pectively, to products purchased after the

date of EPA’s decision. Unlike the currentsystem, it would implement changes much sooner after EPA concluded they were needed.

To the extent that the web-distributed labeling system incorporates a limited lifespan on labeling, it would straightforwardl y permit EPA to apply new requirements to products that had not been completely used up prior to the posting of the changes on the website. As noted above, if users possess some quantity of a pesticide for which their downloaded labeling had expired, they would need to obtain and follow all requirements contained in new, current versions of labeli ng for the products. Therefore, all of EPA’s regulatory decisions would eventually take effect as the lifespa n of older labeling expired. For example, if EPA had imposed new risk mitigation measures on all labeling downloaded after April 8, 2009, and downloa ded labeling had a 12-month lifespan, by April 8, 2010, all users should be complying with the new risk mitigation measures.

Of course, a user who failed to use up a ll of the pesticide during the lifespan of the labeling would take a chance that the pes ticide could no longer be used in the manner allowed when the user acquired the product. For example, a user might buy a pesticide that he intended, under web-distributed labeli ng, to use on his green beans in 2009. If the

February 27, 2009 5 of 9 PPDC Discussion Paper Draftpest problem that would have necessitated using the pesticide di d not occur in 2009, and the labeling had a 12-month lifespan, the us er would then need to download a new version of the labeling to c over use in 2010. There would be some possibility that the new version of the labeling might no longer allow the green bean use. Such a change would, however, be unlikely since the Agency does not or dinarily limit the use of a pesticide except as a consequence of the periodic EPA reexamination of existing pesticides through the registra tion review process. (In regi stration review, EPA plans to reexamine all registered pesticides at l east every 15 years. Thus, apart from the unexpected appearance of new data, changes to restrictthe use of a pesticide will not occur as frequently as other kinds of change s.) The potential for future labeling changes that might affect the intended use of a pesticide would, nonetheless, create an additional incentive for users to use up their inventory of pesticide products w ithin the lifespan of the labeling valid when they purchased thei r product. Many stakeholders have argued that if EPA adopts an appro ach that creates a limited lifespan for downloaded labeling, the lifespan should be quite le ngthy in order to avoid creati ng unusable inventories of the product that would require expensive disposal.

There are at least four ways to mitigat e this disadvantage of a finite labeling lifespan: 1] advance notice to users; 2] the development of “user-to -user sales markets;” 3] repurchase by the registrant; and 4] length of the lifespan. Each is explained below.

To the extent EPA knows that it will be making a change in product labeling that will significantly limit an approved use, th e Agency could minimize the potential for

users to be left with unusable inventories by indicating on download ed labeling the dates when uses will be canceled or other signi ficant risk mitigation measures will be implemented. Here is how this could work under the web-distributed labeling system. Assume that in 2009 EPA and the registrant agreed that use A would be “phased out” by the end of 2011, i.e., in 2012 and afterwards, th e product could not be sold with labeling permitting use A. Once that agreement had been reached, all downloaded labeling could contain a statement that use A was prohibite d, effective January 1, 2012. This statement would appear on all downloaded labeling for years before it took e ffect, and all users would have ample advance notice. Note th at even though labeling downloaded in the fall

of 2011 would be valid for other uses afte r the phaseout date, under the downloaded labeling the product to be used for use A only until January 1, 2012.

Another way to address the problem of unusable inventory is through the development of user-to-user sales markets. In this kind of secondary sales market, a user, who no longer could apply a product for the us e intended at the time of purchase, would offer the product to buyers who might want to use the product for one of its lawful remaining uses. EPA would encourage such secondary sales, because they would cost less and be environmentally preferable to disposal of the product. The Agency understands, however, that so me states impose regulatory requirements that may constrain the operation of such markets. EPA intends to work with states to explore how to allow safe, efficient operation of secondary sales markets.

February 27, 2009 6 of 9 PPDC Discussion Paper DraftRegistrants could help to address this problem by re purchasing unusable products from its customers. While there is not likely to be a legal requirement on registrants to do so, a company that offers this option will build significant good will among its customers. Further, since the product would likely not need relabeling, it is likely to impose relatively smaller burdens on the registrant.

Finally, as suggested by many stakeholders , the problem of u nusable inventories could be lessened by extending the time period for using up the product. But, of course, extending the lifespan of the labeling would tend to reduce the adva ntages of having a limited lifespan for downloaded labeling. The ne xt section discusses this issue in more depth.

Comparison of options . Each of these two approaches has advantages and disadvantages:

Pros Cons Labeling linked to • Similar to historical • Delays comprehensive production date system.

• Users may always use a pesticide according to the labeling approved

at the time of

manufacture. implementation of new risk mitigation measures.

• Does not change users’ incentives to act unlawfully by refilling containers with out-of-date labeling.

Labeling with a finite, limited lifespan linked to

the “download

date” • Would ensure comprehensive,

timelier implementation of new risk mitigation

measures.

• Would create an

additional incentive

for users not to acquire and hold large inventories for long periods of

time. • Represents a change to historical system.

• Users would need to acquire a new version of the labeling if they did not use up all of the pesticide within the labeling lifespan, a modest additional

burden.

• Users would face some

chance that new versions of labeling would change the way in which a product could be used, making it “unusable.”

• Any unusable product would need to be disposed of properly, increasing the costs to users and / or registrants.

B. How Long Should the “Lifespan” of Downloaded Labeling Last?

If EPA imposes a limited lifespan on the validity of downloaded labeling, such an approach has the potential to accelerate the pace with which users should begin

February 27, 2009 7 of 9 PPDC Discussion Paper Draftcomplying with changes in the directions and restrictions on pesticide labeling. Obviously, the shorter the lifespan of downloaded labeling is, the more rapidly the new risk mitigation measures will apply to all users. This important benefit, however, must be weighed against the possibility that a new labe ling restriction will represent so significant a change that the user will no l onger be able to ap ply the pesticide as originally planned. For example, if EPA cancelled the registration of a pesticide for a sp ecific use, once the labeling changed and the lifespan of old labeling (the labeling which allowed the cancelled use) expired, users who had bought th e pesticide intending to apply the product for that use would be left with a product of little or no value to th em. Although this type of cancellation is rare, the imp acts can be serious. In the past, EPA has negotiated with the registrant to accept return of unused product, but the Agency cannot necessarily compel such a solution, which would put incr eased burden on the end user following the cancellation. The Agency also recognizes that while changes in use directions or other restrictions may not effectuate complete cancellation of a use, for some users such changes may operationally have a comparable effect. For example, a new labeling requirement to employ highly specialized appl ication equipment may result in a “ de facto cancellation” for some users because they cannot afford the added cost of buying or renting such equipment. Extending the lifes pan of downloaded labeling, however, would reduce such potential impacts by allowing users additional time to use up the pesticide they have purchased.

Most people think the lifespan of downloa ded pesticide labeling should be only as long as users would typically need to us e up purchased pesticide products. Longer lifespans would potentially de lay the implementation of important risk mitigation measures. Conversely, shorter lifespans w ould potentially impose some burden on users to obtain new versions of labeling and occas ionally could lead to some quantities of purchased pesticides becoming unusable due to changes in labeling.

The Agency believes there is considerable variation across kinds of pesticides and among users of the same type of pesticide produ ct in terms of the timing of when a user purchases a product in relation to when the userintends to use the product, as well as in terms of how much and how long a user k eeps inventory. The timing of use of an agricultural pesticide depends on the production cycle of the crop to which the pesticide is applied and the timing of the occurrence of pest problems. In general, before the start of the growing season an ag ricultural pesticide user wi ll typically purchase the pesticide(s) he expects to apply during the season. Representatives of various agricultural groups have indicate d that a grower would expectalmost always to use up the purchased pesticide during the crop’s gr owing season. Excess pesticide carried over to the following growing season would repres ent an unproductive capital expense. Other kinds of pesticide products do not have the sa me cyclical use pattern s. Other pesticide uses – for example, in the wood preservati ve treatment, for slime control in paper production, or in greenhouses – may occur more or less constantly throughout the year. In such cases, EPA thinks users would typi cally try to maintain enough inventory to

address both scheduled and une xpected pest-control needs. But, like agricultural users, these users try to limit the quantity of pestic ide products in their inventories to minimize cost. Thus, they will generally try to carry only as much as they need to address shortFebruary 27, 2009 8 of 9 PPDC Discussion Paper Draftterm needs until such time as they could obtain any needed resupply. Nonetheless, representatives of some non-agricultural pestic ide users have indicated that occasionally individual users will keep a pe sticide in inventory to deal wi th infrequently occurring pest problems and will only need to purchase a new quantity of the pesticide every several

years.

In sum, EPA thinks that most users of most pesticides obtained for use in a business context will, for financial reasons, try to minimize the size of their inventories and how long they hold a product. They will attempt to buy only as much pesticide as they think they will need to use before they could reasonably obtain a new supply to meet their anticipated pest-control needs. Accord ingly, EPA would expect that a pesticide user in a business context would rarely hold si gnificant quantities of pesticide products for longer than a year, and usually for much shorter periods.

Balanced against the impacts on the us er are the benefits resulting from implementation of the labeling requirements. The Agency directs changes in labeling in order to mitigate risks to public health or the environment. The sooner users implement such changes, the quicker the unreasonable risks are redressed. EPA has previously considered how to weigh such impacts inits Endangered Species Protection Program (ESPP). In this program EPA w ill vary localized rest rictions on the use of a pesticide in order to avoid potential adverse effects on threatened and endangered species. The Agency will communicate these localized re strictions to users through ESPP County Bulletins, available from an EPA website. Pe sticide products will require users to obtain and comply with all requirements in the bu lletin(s) for the counties in which the products will be used. After weighing the urgency of implementing new protections for endangered species and the users’ need to rely on being able to apply a product to address his future pest control needs, EPA decided that ESPP bulletins will be valid only for a 6 month period following download. (It should be noted that users c ould be confused if web-distributed labeling has a different lifespan from ESPP County Bulletins.)

RECOMMENDATION:

EPA supports the position that web-distributed labeling should have a timelimited lifespan calculated from the date on wh ich it is downloaded or requested by tollfree telephone system. The Agency does not yet have a recomme ndation regarding the specific lifespan for web-distributed labeli ng. While it should be long enough to allow most users to use up the quantities they purchas e, it probably should notlast significantly longer than a single use season. Finally, EPA would also support taking steps to diminish the potential for creating unusable inventories, especially pr oviding advance notification of EPA phase-out decisions, i. e., decisions that specified uses of a pesticide would no longer be allowed after a certain date.

February 27, 2009 9 of 9 PPDC Discussion Paper Draft