PPDC Web-Distributed Labeling Workgroup Discussion Paper Enforcement of Web-Distributed Labeling

I. Introduction

This paper discusses the enforceability of web-distributed labeling and potential impediments to effective compliance monitoring a nd enforcement of the labeling provisions of FIFRA. EPA is working to establish a syst em whereby purchasers and users may obtain a legally valid copy of the labeling for a pestic ide product from a website , toll-free telephone service, or other delivery mechanism. Web- distributed labeling raises potential compliance monitoring and enforcement issues relevant to the pesticide’s registrant, dealers (or other distributors), and users.

Pesticide labeling is a critical component of the regulatory framework for ensuring that a pesticide’s use will not cause adverse effects on man or the environment. As part of the process of registering a pesticide product, EPA must ensu re that the product’s labeling is sufficient to allow a user to apply the produc t safely. Registrants are resp onsible for ensuring that the labeling on a pesticide product accu rately reflects the labeling accepted by EPA in connection with the product’s registration. Pesticide user s are responsible for applying the product as required by the label. The provisions of a pr oduct’s labeling are gene rally enforceable, and violations of a product’s labeli ng are punishable by civil or criminal penalties under FIFRA § 14.

A person may not distribute or sell any pestic ide that is not regist ered under FIFRA. All pesticides must be distributed bearing their EPA- approved pesticide labels. It is unlawful for any person to sell or distribute a re gistered pesticide with claims that differ from those approved by EPA or is misbranded. A pesticide is “misbranded” if, among other things, its labeling: bears any false or misleading statement; does not bear th e establishment or product registration number; does not prominently display any required wor d, statement, or other information; does not contain directions for use that are adequate to protect health and the environment; does not contain a warning or caution statement adequate to protect health and the environment; or does not contain the use classification. Normally, regi strants attach the most current approved version of product labeling to the containers that they release for shipment. 1

Under current practice, most pesticide products are distributed with the requisite labeling accompanying the pesticide container at the point of sale, commonly as a leaflet or booklet. 2

Consequently, each time that a pesticide is used up and its container disposed of, the user must obtain a new container with new labeling that he cannot alter or deface. This means that the labeling accompanying the container is legally valid for as long as the user possesses the specific product container, and is only valid with respect to the quantity of pe sticide originally within that

container.

1 However, under certain circumstances EPA allows previously approved labeling, which is not the most current version, to be distributed or sold by the registrant for a period of 18 months after EPA’s approval of a labeling revision. See 40 CFR §§ 152.130(c) and (d).

2 A current exception to this rule is fumigants.

June 4, 2009 1 of 9EPA is considering a system that would esta blish a new way of making the labeling of a pesticide product available to purc hasers and users. Instead of obtaining the full product labeling along with the pesticide containe r at the time of product purchas e, a purchaser would obtain a copy of the labeling either by downloading a f ile from a website or by calling a toll-free telephone service that would then mail or fax the labeling to the caller. While the responsibility of the pesticide purchaser/user to obtain and follow all label and labeling instructions will not change under the proposed system, how the user obtains the most current labeling will. The Agency’s expectation is that the purchaser/user will have in their possession the most recent and pertinent labeling information approved by EPA in cluding directions for use. Because the new system will depart from the current federal a nd state practice of associating labeling with a specific pesticide container (which physical association effectively creates the limited lifespan for the validity of labeling), the new system rais es liability questions fo r pesticide registrants, dealers, and users. The proposed framework al so raises enforcement issues for EPA and the states because collecting the labeling accompanying the product at the time of the violation is critical to successful compliance monitoring and enforcement.

Pesticide labeling is enforced by FIFRA § 12 which lists various unlawful activities. FIFRA § 12(a)(1)(B) declares it unlawful for an y person to distribute or sell a product whose

claims differ from those made in connection with its registration. FIFR A § 12(a)(1)(E) declares it unlawful for any person to distribute or sell a misbranded product as defined in § 2(q). FIFRA §12(a)(2)(A) declares it unlawful for any person to de tach, alter, deface, or destroy, in whole or in part, any labeling required under the Act. FIFRA §12(a)(2)(G) declares it unlawful for any person to use any registered pesticide in a manner inconsistent with its labeling. FIFRA §12(a)(2)(H) declares it unlawfu l for any person to use any pesticide which is under an experimental use permit contrary to the provisions of such perm it. FIFRA §§ 13 and 14 describe the actions the Agency may take in response to violations of the Act.

A registrant generally must obt ain a State registrati on to sell or distri bute a pesticide in

that State. 3 States may also regulate the sale and use of any pesticide in the State but only if the regulation does not allow any sale or use prohibit ed by FIFRA. States have primary enforcement authority for pesticide use violations. EPA gene rally pursues violations of the FIFRA’s labeling requirements. Compliance monitoring will be a join t federal-state effort to monitor labels in the marketplace and ensure that applicators are usin g current and appropriate labels when applying pesticides.

II. Enforcement of a Registrant’s Responsibilities

A. Overview

Currently, registrants are ultimately held responsible for ensuring that the labeling accompanying a product when it is released into ch annels of trade is current and accurate. FIFRA §§ 2(q) and 12(a)(1)(F) and 40 CFR Part 156. Although the registrant may enter into contracts with other parties acti ng as the registrant’s agent to produce or label products, the registrant is still ultimately re sponsible for the labeling of the product. Under a web-distributed

3 Certain pesticides are not registered with EPA even thou gh registration is required at the state level (e.g., Section 25(b) pesticides or medical disinfectants regulated by the FDA).

June 4, 2009 2 of 9labeling scenario, the registrant would still be responsible for en suring that current and accurate labeling is available for users to obtain. By lis ting a website address on th e label, the registrant would take responsibility for the content of the website. There are a number of methods that have been proposed for distribution of labeling, including authorized web sites, fax-on–demand services or toll-free telephone lin es to request a copy of the labe l. Regardless of how the user obtains the label, the registrant would be responsible for the la beling content delivered to the user. The user of the product would be responsible for obtaining the most recent version of the labeling appropriate for the state in which the application will take pl ace, and for following the labeling’s directions for us e. FIFRA § 12(a)(2)(G).

While the registrant would be responsible for providing the latest EPA approved label to the user, there may be instances where the Agency may also find the operato r of the registrant’s

website liable for violations of FIFRA regarding the website’s ope rations and content. FIFRA § 14(b)(4) provides that the act, omission, or failure of any officer, agent, or other person (e.g., a website host) acting for or employed by any pers on regulated by FIFRA (e.g., a registrant) shall be deemed to be the act, omission, or failure of such person as well as that of the person employed. As with current prac tice, the Agency may charge the website’s operator as the registrant’s agent with violating FIFRA, as well as the registrant itself, depending on the circumstances of the violation. The Agency is considering whether regi strants seeking to use web-distributed labeling for their pr oducts should be required to subm it, as part of the pesticide’s registration under FIFRA § 3, documentation of their arrangements with website operators. Such a requirement would serve many purposes incl uding the following: (1) it will encourage registrants to enter into contract ual agreements with reputable webs ite operators; and (2) it will expedite federal and state compliance monitoring efforts.

B. Potential Problems with Web Distributed Labeling

1. Incomplete, Inaccurate or Differi ng Labeling Provided by the Website

Discrepancies between the web-distributed labeling a nd the EPA-approved master labeling might include the following situations:

° The labeling on the website doesn’t accurately reflect the current EPA-approved labeling 4

o The user requests a subset of the labe ling by use from the site but the query returns an incomplete document (although complete and accurate labeling is available on the website).

o Labeling is available for a user in a stat e which has not approved the use of that specific pesticide in that specific state. 5

4 See the next section for a discussion of how to approach a discrepancy that arises from the failure of the website to reflect an approved revision.

5 Note: this would not necessarily constitute a violation of FIFRA, but would constitute a violation of state law in

most or all states.

June 4, 2009 3 of 9Providing inaccurate or incomplete labeling from the website would violate FIFRA §§ 12(a)(1)(B) or FIFRA 12(a)(1)(E). Please note th at both authorities would apply to any person who is selling or distributing pesticide products. In addition, the registrant and/or website operator would be liable under FIFRA § 12(a)(2)( A) if the labeling is altered in whole or partially. This provision does not re quire that the pesticide be sold or distributed as in the case of violations committed under FIFRA § 12(a)(1). If website labeling is noncompliant, EPA has enforcement authority under FIFRA §§ 14(a) or 14 (b) to charge the registrant and/or website host with violating FIFRA.

2. Website Fails to Reflect Most Re cent EPA Approved Master Labeling

If the website does not provide the most re cent, updated labeling to users requesting downloads of such labeling, the registrant, webs ite-operator, and user may find themselves in violation of FIFRA. 40 CFR Part 152 provi des the procedures, requirements and criteria concerning the registration of pesticides unde r FIFRA § 3. 40 CFR § 152.130(c) currently allows the registrant of paper-based labeli ng18 months to sell produc ts under previously approved labeling before voluntary amendments to the labeling must appear on the product, unless otherwise directed by an order issu ed under FIFRA §§ 6 or 13. 40 CFR 152.130(d) allows the Agency to specify a date by which a product’s label is required to be revised as a result of a Registration Standard, Label Improve ment Program notice, or a notice concluding a special review process.

The part 152 rules discussed above were wri tten in the context of a system in which paper-based labeling accompanied product containers; these ru les do not make sense for a product that relies on web-distribu ted labeling. A registrant could easily post new versions of the product labeling on its website and much more qu ickly than registrant s can produce new paper versions of the labeling to attach to the product containers they release for shipment. To the extent that a labeling revision contained new di rections that would mitigate risks of using a product, EPA thinks it important for such revi sions to reach the users as soon as possible. 6 To implement such a policy, the Agency would need to pursue one of two approaches. EPA could amend the rules in 40 CFR 152.130 to limit their app licability to paper-based labeling sent with product containers. Alternatively, EPA could impose a condition on any approval of amended labeling that the registrant would need to change the website to reflect the revision within a short specified period of time. If EPA establishes new time requirements for implementing amendments to web-distributed labeling, thos e requirements would govern how quickly after approval a revision to labeling must be reflecte d in the posting of mate rial to a web site.

It is unlawful for any person to distribute or sell any registered pe sticide if any claims made as part of the pesticide’s sale or distribu tion differ from any claims made as part of the pesticide’s registration. FIFRA § 12(a)(1)(B). Assuming that the Agency has established a time period for changing the website to reflect a pproved labeling amendments, EPA has several options if the website does not provide the most recently approved labeling. First, if the website

6 There could be less urgency for posting other types of labeli ng revisions, e.g., the addition of new uses. In order to give a registrant the ability to manage the marketing of a pr oduct, EPA could allow a registrant flexibility in when to post a revision that does not involve risk mitigation.

June 4, 2009 4 of 9does not post labeling in a timely manner and time ly posting is a condition of registration, EPA has (1) enforcement authority under FIFRA §§ 14 (a) or 14(b) against th e registrant and/or website host, and/or (2) cancel the conditional registration under FIFRA § 6(e). Second, the failure to timely update the labeling will resu lt in a misbranding violation committed by the registrant. If the registrant ha s been granted only a certain pe riod for using previously approved labeling, after that period runs anything other than curren tly approved labeling would be misbranding violations under FIFRA § 12(a)(1)(E).

3. Website is Nonfunctioning and Labeling is Not Available

In order for the web distributed labeling syst em to be viable, users must be able to consistently and reliably access the website 24 ho urs per day. Normal interruptions of service (e.g., routine maintenance) are to be expected, bu t when does a website become too unreliable to provide timely service? EPA s hould establish a website performance standard and make adequate website functionality a condition of registration for products with web-distributed labeling using FIFRA 3(c)(7)? 7 If a website is not availa ble as prescribed by conditional registration, EPA has authority to (1) cancel the conditional registration under FIFRA 6(e); and/or (2) initiate an enforcem ent action under FIFRA §§ 14(a) or 14(b) against the registrant

and/or website host.

A consequence of the website’s unavailability may result in a user violating FIFRA § 12(a)(2)(G). For example, if a user must apply a pesticide im mediately and cannot obtain the directions for use in a timely ma nner, a violation would occur even if the user applies the product

based on his best recollection of th e lawful application rate even if his recollection is correct. In such a situation, the user would be in violation of FIFRA 12(a)(2)(G) fo r misuse of a pesticide.

C. Compliance Monitoring for Registrants

Registrants are responsible for ensuring that the content of web sites is accurate and current. The registrant is also responsible for ensuring that users can re liably access a web site and that there are other means of obtaining labe ling if the user cannot ac cess the web site. In order to perform timely and appropriate comp liance monitoring, federal and state pesticide programs must have the infrastructure necessary to carry out it objectives, including hardware, software, staff, and cooperative agreements. It is absolute necessary for successful compliance monitoring and enforcement that EPA timely dissemi nate to the states the most recent master label so that field inspectors can accurately comp are the master label with the marketplace label. In addition, state pesticide laws must be evaluate d to see if revisions ar e necessary to address web-distributed labeling violations . EPA and the states will mon itor compliance with the content and availability of web distributed labeling. Web distributed labeling should streamline the process and with unique identifiers for labeli ng compliance monitoring will become easier for the states. Container labeling will be shorter and comparison with the label on file with the state can be done more easily and may not require a field inspection.

7 Setting a performance standard may require rulemaking. However, this option would make meeting the standard a requirement for users of web distributed labeling without having to utilize the condition of registration route.

June 4, 2009 5 of 9III. Enforcement of Responsibilities of Dealers and Others who Sell or Distribute

Pesticides

Under current law dealers and other distributors of pesticid es are also responsible for providing EPA approved labeling to their customers when they sell or distribute a registered pesticide. FIFRA §§ 12(a)(1)(B), 12(a)(1)(E), an d 12(a)(2)(A). However, Congress intended to allow any person who violates FIFRA § 12(a)(1) to sh ift his or her liability to the registrant from whom the person purchased or received the pesticid e if that person holds a “guaranty” in writing from the registrant. FIFRA § 12(b)(1).

As noted in the background section of th is document, the proposed web-distributed labeling system would modify current labeling practices by severing directions for use from physical placement on the pesticide container. Us ers would be required to comply not only with the restrictions appearing on the label affixed to the container and in the labeling accompanying the container, but also with the additional labeling referenced on the pesticide container. As long as the dealer or other distributor provides the purchaser with all of th e labeling required by the EPA-approved registration except for the web-dist ributed labeling itself, the dealer or other distributor of the pesticide would not be in violation of FIFRA. Dealers may, as a service to their customers, provide the means for a user to obtain labeling through an internet connection whereby the customer can download the labeling for the product he just purchased. Offering this

service does not make the dealer liable for the fa ilure of the user to obtain the proper labeling. Nor does providing the means for obtaining labeling make the dealer’s facility a production facility and subject to establishment registration. In sum, de alers would need to meet the same state and federal requirements for selling pesticides they are now subject t o. Further, a dealer

will not be liable for inaccurate or outdated web- distributed labeling as described in Section II. except in the unusual situation where such person is affiliated with the website.

IV. Enforcement of Users’ Responsibilities

A. Overview

For paper-based labeling, the us er is responsible for comply ing with the requirements of product labeling obtained when th e user took possession of the pr oduct’s container. The user must comply with all instruc tions and requirements in the la beling [FIFRA § 12(a)(2)(G)] and must keep the labeling as long as he has the container [F IFRA § 12(a)(2)(A)].

Under a new web-distributed labeling appro ach the attenuation of the labeling and the product container creates an issue about whethe r the downloaded labeling may be associated

with different containers obtaine d over time. If the labeling is not uniquely associated with a container that the user empties and disposes of, the user could continue to use a “legacy” version of the 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 could, in theory, be used with any product container unless there was a restriction that limited its appl icability to specific containers or for a specific time period. Unless users must replace old labeling for a product with an updated version of the

June 4, 2009 6 of 9labeling, any improved protections for public he alth and the environment would not be a condition of use at the time of application.

The Agency has developed two options fo r linking labeling to specific pesticide containers. The first option is labeling linke d to a production date, which would allow the pesticide to be used according to any version of the labeling 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 pe sticide, the user woul d need to obtain a new container of the pesticide labeled with a new “p roduced by [date].” Labeling that predated the production date on the newly obtained quantity of pe sticide would no longer be valid. In effect, this approach gives web-distri buted labeling an indeterminate lifespan equal to the amount of time a user takes to use up the pesticide material.

Under a second approach, referred to as the finite labeling lifespan, the pesticide could lawfully be used according to the downloaded labeling only for the stated lifespan of the labeling. Consequently, if a user thought he mi ght still possess some quantity of the pesticide after the lifespan of his version of the labeli ng had expired, he would need to obtain a newer version of the labeling with a lif espan running until a later expirati on date. Of course, the user would be required to comply with all directions and rest rictions on the subsequent version of the labeling. So too would users who purchased a pesticide after EPA had implemented new risk mitigation measures through revisions to the ve rsion of a pesticide’s labeling posted on the

website.

Web distributed labeling will maintain the user’s responsibility for obtaining and following the labeling requirements. However, the user must take a more active role in obtaining the product labeling. The pesticide product’s contai ner will bear most of the labeling with the exception of the directions for use. The pr oduct label will require th e user to obtain the directions for use prior to applying the product. Because the product label references the web site and requires the user to obtain further la beling, downloading the label itself will not trigger the production establishment requirements of FIFRA § 7.

B. Potential Problems

1. Misuse of the Pesticide

The container’s label will require the user to obtain the labeling refe renced on the pesticide container (i.e., directions for use) prior to hi s/her mixing, loading, or applying the pesticide.

Failure to obtain the directions for use as required by the container’s label will constitute misuse and violate FIFRA § 12(a)(2)(G). There is an issue with respect to what actions by a user would constitute having a copy of the labeling in hi s possession. EPA would regard having either a paper copy of the downloaded labeling or an electr onic file as meeting the requirement to have a copy of the labeling. Further, if the user had mu ltiple containers of the same product, he would need to have only one copy (paper or el ectronic) of the labe ling for the product.

A user could not use the unavail ability of a website as a reas on for not obtaining a copy of the web-distributed labeling. The container label will provide at least one alternative method of

June 4, 2009 7 of 9obtaining a copy of the labeling, and EPA would expect the user to employ the alternative

method in case the website were not available.

The container’s label will also require the user to follow the web-distributed labeling. Failure to follow the use directions or other requirements contai ned in the web-distributed labeling violates FIFRA § 12(a)(2)(G). If the us er obtains an incorrect version of the labeling and applies the pesticide consistent with that la beling’s directions, it is nonetheless a violation of FIFRA § 12(a)(2)(g) because FIFRA is a strict liability statute. 8 The user’s liability exists regardless of whether the labe ling archived on and downloaded from the website was correct.

2. Recordkeeping Issues

FIFRA allows EPA to require commercial a pplicators to create and maintain records when using restricted use pesticides and prohi bits EPA from requiring private applicators to maintain records or file reports. However, the states may require recordkeeping by all applicators, and many states pres ently require recordkeeping that exceeds federal recordkeeping requirements. Since states have primary us e enforcement authority, recordkeeping for webdistributed labeling involved with misuse violations becomes largely a state issue. Thus, it may be appropriate for states to determine what constitutes appropriate recordkeeping unless a minimum standard is not implemented by the states.

C. Compliance Monitoring for Users

States have primary use enforcement author ity and would monitor us ers to ensure that they possess and follow current labeling when applying a product.

V. Violations

Under both the current and proposed FIFRA Enforcement Response Policy (ERP), each “independent violation” of FI FRA is subject to an enfor cement action. A violation is independent if it results from an act (or failure to act) which is not the re sult of any other charge for which a civil penalty is to be assessed, or if the elements of proof for the violations are

different. Consistent with the above criteria, the Agency consid ers violations that occur from each shipment of a product (by product registration number, not individual containers), or each sale of a product, or each i ndividual application of a product to be independent violations. 9 Each of these independent violations of FIFRA is s ubject to civil and crimin al penalties FIFRA § 14.

Under the FIFRA ERP, for example, when EPA can document that a registrant has distributed a misbranded product (o ne single EPA product registrati on number) in four separate shipments, EPA will charge that registrant with four counts of selling or distributing a

8 The user will be able to argue as an affirmative defense the correctness and accuracy of the downloaded labeling.

9 Independent violations which can be documented as both per sale and per shipment are to be calculated only as either per sale or per shipment, whichever is more appropriate based on the supporting documentation, and whichever approach yields the highest civil penalty. For example, if Person A has a violation involving one sale and two shipments, and Person B has a violation involving two sales and one shipment, both persons would be charged for two violations of FIFRA (Person A is charged for two shipments and Person B is charged for two sales).

June 4, 2009 8 of 9misbranded product. Similarly, when the EPA can document that a registrant has shipped four separate misbranded products (four separate EPA product registration numbers) in a single shipment, EPA will charge the registrant four counts of selling or distributing a misbranded product. An example of a dependent violation is multiple misbranding on a single product label. EPA may assess a count of misbranding each time that a misbranded product is sold or distributed. For example, a registrant who sells or distributes four di stinct shipments of a misbranded pesticide product generally may be asse ssed a civil penalty for four violations (each time that a misbranded pesticide is sold or dist ributed). However, if a single product label is misbranded in one way or ten ways, as defined by FIFRA § 2(q), it is still misbranding on a single product label and is considered a single violation of FIFRA § 12(a)(1)(E).

Enforcement actions for web-distributed la beling violations should follow the current system. Thus, violations shall be determined on the following basis:

1. Each time inaccurate, incomplete, or nontimel y labeling is downloaded by a user, the registrant and/or website host commits, de pending on the facts, a single, independent violation of FIFRA §§ 12(a )(1)(B) and/or 12(a)(2)(E).

2. Each time a user attempts to download a we b-distributed label from the website but the website is unavailable, the registrant and/or website host commits a single, independent violation of FIFRA § 12(a)(1)(B).

3. Each time a user applies the pesticide without possessing th e appropriate labeling is a single, independent violati on of FIFRA § 12(a)(2)(G).

June 4, 2009 9 of 9