# U.S. E NVIRONMENTAL 

# P ROTECTION 

# A GENCY



# September

2013 

# Repellency Awareness

Guidance

For Skin-Applied Insect Repellent Producers

Office of Pesticide Programs

EPA Document No. 730-C-13-001September 2013 

### Repellency Awareness Guidance

Page 2 

### Table of Contents

Guidance Summary .............................................................................................................. ........... 3

I. Introduction ............................................................................................................... .................. 4

II. Background ................................................................................................................ ................ 4

III. Applicability – Products for Which This Graphic is Intended ................................................. 5

IV. Non-binding Nature of This Guidance ..................................................................................... 6

V. Recommended Criteria ....................................................................................................... ....... 6

A. Type of Product ............................................................................................................ .......... 6

B. Pest Claims that the Graphic Represents ................................................................................ 6

C. Complete Protection Time (CPT) .......................................................................................... 8

D. Minimum Duration of CPT Re presented by the Graphic ...................................................... 9

VI. Implementation – How to Obtain the Graphic ......................................................................... 9

A. Registration Applications .................................................................................................. ..... 9

B. Claims of Confidentiality .................................................................................................. ... 11

C. Data Citation and Compensation .......................................................................................... 11

D. Human Research Ethics Considerations .............................................................................. 11

E. Where to Send the Application............................................................................................. 1 2

F. Review and Determination ................................................................................................... 12

VII. Use of the Graphic on a Product La bel and in Marketing Materials ..................................... 12

A. Repellency Awareness Graphic Design ............................................................................... 13

B. Label Language Relating to the Repellency Awareness Graphic ........................................ 14

C. Other Labeling, Marketing, and Related Materials .............................................................. 16

D. Writing and Speaking About the Repelle ncy Awareness Graphic and Effort ..................... 16

E. Use of the Graphic without EPA Review of Data ................................................................ 16

F. Terms of Use for the Re pellency Awareness Graphic .......................................................... 17

VIII. Paperwork Reduction Act Notice ........................................................................................ 1 8

IX. Information Contact ....................................................................................................... ......... 18

### Repellency Awareness Guidance September 2013

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### Guidance Summary

The purpose of the repellency awareness graphic is to enhance public health information for skin-applied insect repellent products by improving the prominence and clarity of product

effectiveness claims on labels.

The Environmental Protection Agency (EPA) repellency awareness graphic is voluntary and

intended for registrants of new and existing skin-appl ied insect repellen t products that are subject to the Federal Insecticid e, Fungicide, and Rodenticide Act (FIFRA). Applications to add the repellency awareness graphic to a product label will be subject to the Pesticide Registration Improvement Extension Act (PRIA 3).

The agency intends that registrants use the repellency awareness graphic to communicate the duration of repellent effi cacy of a product against mosquitoes and/or ticks . Any other arthropods listed on the label are not included as part of this e ffort and should be supported by separate efficacy data.

Data Generation , if needed, should follow guidance in EPA’s Office of Chemical Safety and Pollution Prevision (OCSPP) Harmonized Test Guideline 810.3700 and undergo human research

ethics review.

For mosquitoes , median complete protection times (CPTs) should be calculated from results of product performance field studies at two distinct habitats wher e predominant mosquito species differ. The mosquito claim should be cal culated using the most conservative ( i.e. , lowest) CPT

from all available field studies. The most c onservative CPT should be a minimum of two hours in order for a mosquito efficacy claim to be made in the repellency awareness graphic.

For ticks , CPTs should be calculated from results of te sts on three tick species suggested in this guidance. The tick claim should be calcu lated using the most conservative ( i.e. , lowest) CPT from all available tick species tested. The most conservative CPT should be a minimum of two hours in order for a tick efficacy claim to be made in the repellency awareness graphic.September 2013 

### Repellency Awareness Guidance

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### I. Introduction

This document presents the U.S. Environmenta l Protection Agency’s (EPA or the agency) guidance to industry for participation in the repelle ncy awareness effort for one or more pesticide products. This effort is limited to pesticide produ cts subject to FIFRA labeled for application to skin for the purpose of repelling mosquitoes an d/or ticks. This guida nce provides specific information regarding how applican ts for new registrations or regi strants of currently registered products can apply to EPA for approval to add a graphical claim to the product label. The graphic is a standardized desi gn intended to clearly communicate to consumers the product’s effective repellency in number of hours against mosquitoes and/or ticks when the product is used

as directed on the label. EPA undertakes efforts such as this in order to improve and clarify pesticide product labeling for consumers and to promote public health protection. Although seeking approval to add this graphic to a pestic ide product label is voluntary and this guidance creates no enforcement authority in and of itself, th e inclusion of this graphic, or some variation of this graphic, on a pesticide product label with out engaging the agency as recommended in this guidance may be “false or misleading” under 40 CFR sections 156.10(a)(5) and 152.25(f)(3)(iii) and therefore constitute “misbranding” under s ection 2(q)(1)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and an unlawful act under FIFRA section 12(a)(1)(F), and in the case of pesticide pr oducts registered under section 3 of FIFRA may also constitute an

unlawful act under FIFRA section 12(a)(1)(B).

EPA developed this guidance document to help those who are interest ed in the repellency awareness graphic to understand the types of efficacy data to provide to EP A in order for EPA to approve the addition of the graphical claim to the label. It conveys what the agency considers to

be credible information and sound science needed to support use of the repellency awareness graphic. This guidance document also describes the process for providing such information to EPA and gives recommendations re lating to the placement of the repellency awareness graphic on the product label.



### II. Background

Mosquitoes and ticks can transmit infectious dise ases, including West Nile virus, Lyme disease, and Eastern Equine Encephalitis. Using effective skin-applied insect repe llent products and other preventative actions can discourage ticks, mos quitoes, and other biting insects from landing on you. EPA consumer research has shown that cons umers believe product labels are unclear about product effectiveness, incl uding the repellency time. 1 Consumers want clear and easy-to-find information on product labels that conveys the ty pes of insects 2 repelled and the number of hours of protection against those insects.

Labeling of many skin-applied insect repell ent products does not currently provide easy comparison among products when determining t ypes of insects repelled and duration of

1 USEPA. 2012. Consumer Survey Results on Insect Repellent Labels. http://www.epa.gov/pesticides/insec t/repellent-consumer-survey.html

. 2 The agency recognizes that ticks are arachnids rather than insects, but for simplicity will use the term “insects” for both mosquitoes and ticks in this document.

### Repellency Awareness Guidance September 2013

Page 5 repellency. Thus, as part of EPA’s efforts to pr otect public health and address consumer need for clear pesticide labeling, EPA’s Of fice of Pesticide Programs (OPP) has developed the repellency awareness graphic. Much like the SPF (sun protection factor) 3 on labels of sunscreen products quickly conveys the amount of protection a su nscreen offers against UV-B, the repellency awareness graphic intends to make informati on on demonstrated duration of product efficacy more prominent and standardized on labels of skin-applied insect repellent products. Producers who wish to add the repellency awareness graphi c to their label should consider this guidance before contacting EPA regard ing use of the graphic.

Through the repellency awareness graphic and re commendations in this guidance, the agency intends to improve existing labels by clearly conveying to consumers the expected efficacy of skin-applied insect repellent produc ts, when used as directed. The agency believes that this will help consumers make more informed choices in protecting themselves and family members against mosquitoes and ticks a nd the diseases they may carry.

The graphic is product-specific based on the efficacy data suppor ting the product. Producers of products subject to Federal Insecticide, Fungi cide, and Rodenticide Act (FIFRA) registration requirements must submit to EPA an applicati on for new or amended registration to use the repellency awareness graphic as described in section VI of this gui dance document. These product applications will be subject to the Pe sticide Registration Improvement Extension Act (PRIA 3).



### III. Applicability

– Products for Which This Graphic is Intended

This voluntary graphic and guidance is for produc ers of new and existing skin-applied insect repellent products that are subj ect to FIFRA registration requireme nts. EPA is still considering the possible involvement of skin-applied insect re pellent products that are exempt from FIFRA requirements. These products contain minimum ri sk pesticides and are referred to as “25(b) products,” in reference to section 25 (b) of FIFRA, 7 U.S.C. § 136w(b). See also , 40 C.F.R. § 152.25(f) and http://www.epa.gov/opp00001/biopesti cides/regtools/25b_list.htm . To the extent that producers of 25(b) products become involve d, participation for such a product necessarily may differ from those products requiring regist ration prior to particip ation. The agency may

recommend that information in a ddition to that outlined in this guidance be submitted by a 25(b) producer seeking to use the repellency awarene ss graphic. Additionally, since PRIA is an amendment to FIFRA, EPA cannot accept fees from 25(b) product manufacturers and give a decision date under PRIA with any request seek ing to use the graphic unless the producer chooses to register their product. Therefore, at this time, EP A encourages producers of 25(b) products to apply to register th eir product under FIFRA if interest ed in the repellency awareness graphic.

3 T he SPF program is administered by the Food and Drug Administration, and not EPA.September 2013 

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### IV. Non

­ binding Nature of This Guidance

This document provides EPA’s general guidance to pesticid e producers who may voluntarily request to add the repellency aw areness graphic to th eir product labeling, as well as guidance to the public. This guidance is not binding on either EPA or any outside pa rties, and the EPA may depart from the guidance where circumstances wa rrant without prior notic e. At places in this guidance, the agency uses the word “should.” In th is guidance, the use of the term “should” with regard to an action means that the action is r ecommended rather than mandatory. The procedures contained in this guidance are r ecommended for generating the data and information that are the subject of this guidance, but EPA recognizes that departures may be appropriate in specific situations. Producers seeking to use the repelle ncy awareness graphic may propose alternative approaches to the recommendations in this gu idance document, and the agency will evaluate them for appropriateness on a case-by-case basis.



### V. Recommended Criteria

The recommended criteria listed below intend to guide those interested in the repellency awareness graphic in identifying data to subm it in connection with a request to add the repellency awareness graphic to a pesticide label. In conjunction with this guidance, applicants

should refer to EPA’s Office of Chemical Safe ty and Pollution Prevision (OCSPP) Harmonized

Test Guidelines. 4 In particular, Product Performance Test Guideline, OPPTS 810.3700: Insect Repellents to be Applied to Human Skin 5 provides recommendations for the design and execution of repellent efficacy studies. The complete set of criteria described in those guidelines and this guidance document represent the quality and ch aracteristics of efficacy studies and other information that EPA recommends companies pr ovide to support their proposed repellency claims for the graphic.



### A. Type of Product

This effort is intended for skin-applied insect repellents ( i.e. , a product intended to repel insects when applied directly to human skin) labeled for use against mos quitoes and/or ticks. Repellents making claims to repel pests exclusive of mosquito es or ticks; repellents intended for application to animals or fabric, foliar or general surface sp rays; and products intende d as spatial repellents ( e.g. , coils and candles) are not included at this time.



### B. Pest Claims that the Graphic Represents

The repellency awareness graphic is intended to be used to communicate the duration of repellent efficacy of a product ag ainst mosquitoes and/or ticks. There are three possible claims that may be represented on the graphic: efficacy against mosquitoes only, against ticks only, or against both.

4 USEPA. Harmonized Test Guidelines. Home page. http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm

. 5 USEPA. 2010. Product Performance Test Guidelines. OPPT S 810.3700: Insect Repellents to be Applied to Human

Skin. EPA 712-C-10-001. http://www.epa.gov/ocspp/pubs/frs/publi cations/Test_Guidelines/series810.htm

.

### Repellency Awareness Guidance September 2013

Page 7 Examples of Repellency Awareness Graphics

Mosquitoes:

For mosquitoes, EPA current practice is to only approve a general mosquito claim ( i.e. , a claim to repel all mosquitoes and not a specific mosquito species) on la bels of registered skin-applied insect repellent products. EPA w ill continue this practice in th e repellency awareness effort. Protection against one mosquito species is impractical, and consumers may encounter many different species of mosquitoes in a given area. The mosquito symbol in the graphic will convey a generalized mosquito claim, and data to suppo rt a general mosquito claim should be submitted or cited in an application to use the mosquito symbol in the repellency awareness graphic.

Field testing at two distinct ha bitats where predominant mosquito species differ and preferably cover three different genera is recommended as support for a mos quito efficacy claim for skinapplied insect repellent products. EPA’s policy is to request effica cy data that mimics, to the extent possible, actual use conditions, in orde r to provide the best possible indication of protection time for a typical consumer under environmental conditions. More information on generating data to support a ge neral mosquito claim can be f ound in Product Performance Test Guideline, OPPTS 810.3700. 6

Ticks:

For ticks, the agency has histor ically approved both a general taxonomic tick claim and claims against a single species of tick, e.g. , deer tick, (in the absence of a general taxonomic claim) as text claims on labels. However, the tick symbol in the graphic will convey a generalized tick, and the use of the graphic in the abse nce of data to support a generalized claim against ticks could be misleading. Therefore, data to support a general tick claim should be submitted or cited in an application to use the tick symbol in the repellency awareness graphic.

EPA recommends that studies from three repres entative tick species be submitted to support a tick claim for the repellency awareness graphic. In many cases, there are large differences in duration of repellency between different tick species. The repres entative test species recommended to support a generalized claim agains t ticks are intended to ensure an estimate of repellency duration against the most common disease-bearing tick species.

The representative test species EPA recommends to support a generalized claim against ticks are

as follows:

6 http://www.epa.gov/ocspp/pubs/frs/publi cations/Test_Guidelines/series810.htm

.September 2013 

### Repellency Awareness Guidance

Page 8  Blacklegged tick (commonl y known as deer tick; Ixodes scapularis ), and

 Lone star tick ( Amblyomma americanum ), and

 American dog tick ( Dermacentor variabilis ).

These tick species are not only commonly occurri ng and widespread but are the primary vectors of several important tick borne diseases. The bl acklegged tick is the primary vector of Lyme disease, babesiosis, and anaplasmosis. The l one star tick transmits diseases including ehrlichiosis, STARI (Southern tick associated rash illness), tularemia, and possibly Rocky Mountain spotted fever. The American dog tick is a primary vector of Rocky Mountain spotted

fever and also transmits tularemia.

Information on conducting tick studies can be fo und in Product Performance Test Guideline, OPPTS 810.3700. However, that guideline reflects the historic practice of allowing claims against a single species of tick. Therefore, this repellency awareness guidance should be consulted regarding representativ e test species to s upport a general tick clai m in the repellency awareness graphic.



### C. Complete Protection Time (CPT)

Determination of CPT:

The duration of the CPT for the graphic is de termined through statistical analysis of the supporting efficacy data. The CPT is the time from a pplication of a repellent to test subjects until efficacy failure as demonstrated by the supporting data. Failure is a landing event for a mosquito or a crossing event for a tick confirmed within 30 minutes by a second similar event. As stated in the Product Performance Test Guideline, O PPTS 810.3700, EPA currently uses the median CPT with its 95 percent confidence limits, calculated using Kaplan-Meier estimation analysis, as the summary measure of CPT to support an efficacy cl aim. The agency will c ontinue this practice for applicants of the repe llency awareness graphic.

Multiple data sets:

Data from multiple field locations ( i.e. , for mosquitoes) or multiple species ( i.e. , for ticks) are recommended to support general claims against each of these pest groups so that multiple data sets, each with a calculated CPT, will be available to inform the mosquito and/or tick claims made in the repellency awareness graphic. These CPTs are often different. The most conservative ( i.e. , shortest) CPT from each of the pest group data sets should be used to represent the claim(s) shown in the repellency awareness gr aphic. EPA believes that this will more reliably inform consumers about the general duration of protection provided against each pest group, and thus may better inform a person how to protect themselves from being bitten and potentially exposed to vector-borne diseases.

Rounding:

The number of hours of protecti on appearing on the repellency awareness graphic should be expressed as a whole number. If the most conservative calculate d CPT is not a whole number,

### Repellency Awareness Guidance September 2013

Page 9 EPA recommends rounding down to the nearest whole number. For example, three hours and 45

minutes would be listed on the label as three hours.



### D. Minimum Duration of CPT Represented by the Graphic

The minimum duration of CPT expressed by the re pellency awareness graphic for a product is

the fewest number of hours of repellency ( i.e. , shortest protection time) that the graphic will convey. As described in section V.C., CPT will be based on agency assessment of the submitted efficacy data and statistical treatment of those da ta. Inherent variability in product effectiveness

results from the interactions of factors such as differences in human behavior, host physiology and attractiveness, variable sus ceptibility of pests to a product, and environmental conditions. On this basis, EPA supports two hours as the cred ible minimum protection time for use of the graphic.



### VI. Implementation

– How to Obtain the Graphic

Prior to contacting EPA concerning the repe llency awareness graphic, EPA encourages applicants to review all guidance and materials re lated to this effort. Th e applicant should begin the application process only after the applicant ha s determined that the graphic is appropriate for its product and has identified th e information that may be needed to be considered for the graphic. Information about the process for obtai ning this graphic is provided in the following

subsections.



### A. Registration Applications

This voluntary effort is intended for skin-applie d insect repellent produc ts registered under FIFRA, and EPA views the repelle ncy awareness graphic and the da ta used to support its claims as part of a registered product’s approved re gistration, labeling, and cl aims. Accordingly, the addition of any graphic to a pr oduct’s labeling, including the repell ency awareness graphic, must be requested through an application for new or amended registration under FIFRA, as amended by the Pesticide Registration Improvement Extens ion Act (PRIA 3). Any information or data pertaining to the graphic must be submitted as pa rt of the registration application package.

The process for submitting information to EPA fo r a registration application package will follow existing policies and procedures. Before ma king a regulatory decision on the registration application package that includes the graphic, EPA will review all submitted data, analyses, and proposed labeling to verify that the product meet s both appropriate regist ration requirements and expectations for using the repellency awareness graphic.

1. Data Items

Regulations and guidance for regi stering or amending a registra tion are contained in 40 CFR parts 152, 156, 158, and in guidance, such as pesticide registration notices. 7 Companies seeking to use the voluntary repellency awareness grap hic, which could ultimately involve changes to

7 http://www.epa.gov/PR_Notices/September 2013 

### Repellency Awareness Guidance

Page 10 pesticide product labels previously approved by EPA, must submit any information, data, analyses, and proposed labeling according to these regulations and with these guidelines in mind.

EPA has assembled an online Pesticide Registration Kit 8 which contains the pertinent forms and information needed to register or amend a regi stered pesticide product. In addition, the following items should be included in an application to add the repellency awareness graphic:

 The information, data, and analyses recomm ended in Chapter V of this guidance.

 A proposed master label following the reco mmended label language guidance found in Chapter VII, section B of this guidance, titled “Label Language Relating to the Repellency Awareness Graphic.”

 A list of distributor products, if any, associated with th e pesticide product.

 EPA recommends that applicants also submit a cover letter with th eir submission, stating the general purpose of the submission and identifying each item in the submission package. The cover letter should indicate that the applicant is requesting to participate in the voluntary repellency awareness effort. The letter should also clearly state the pest claim(s) wanted on their graphic ( i.e. , tick only, mosquito only, or both).

For a detailed description of the registration process, please review the Pesticide Registration Manual (Blue Book). 9 All questions regarding pesticide re gistration procedures and specific registration actions should be directed to the appropriate regulatory contact listed at http://www.epa.gov/pesticides /regulating/contacts.htm . Applicants who wish to submit data for the repellency awareness graphic that differ fr om what is recommended in this guidance are encouraged to contact the ombudsperson from the a ppropriate registering di vision to verify that the data will satisfy expe ctations for the graphic.

2. PRIA Fees

As amended by PRIA 3, section 33 of FIFRA, among other things, establishes a registration service fee system for certain types of pesticid e applications and create s a schedule of decision review times for applications covered by the service fee system. Under this system, each individual category corresponds to a certain registration service fee and decision review period. The goal is to create a more predictable eval uation process for affected pesticide decisions, coupling the collection of indivi dual fees with specific decision review periods. The fees and decision review periods may change between fiscal years, and fees are pe riodically increased as prescribed by statute.

PRIA 3 applications are subjec t to fees based upon the type of application. Actions are categorized first by type of chemical ( i.e. , conventional, antimicrobial, or biopesticide chemical product), and next by th e type of action ( e.g. , new active ingredient (nonfood use), new food use, new registration of an old produc t, label amendment requiring da ta submission, etc.). Because the graphic must become an approved part of the product’s registration and labeling and will require some level of review by EPA, the appl icant must comply with any fee requirements

established under PRIA 3 in addi tion to the registration requirem ents referenced in section

8 http://www.epa.gov/pestic ides/registrationkit/

9 http://www.epa.gov/pesticides/bluebook/

### Repellency Awareness Guidance September 2013

Page 11 VI(A)(1) of this guidance document. EPA will follow all existing policies and procedures associated with PRIA 3 applications.

EPA recommends that applicants contact the appr opriate regulatory contact for their chemical,

listed at http://www.epa.gov/pesticides /regulating/contacts.htm , to determine which PRIA 3 code and fee matches their product’s application. Fo r additional information about PRIA 3, please

visit http://www.epa.gov/pesticides/fees/

.



### B. Claims of Confidentiality

Any information claimed to be Confidential Business Information (CB I) will be handled in

accordance with FIFRA Section 10 and the associated CBI regulations contained in 40 CFR Part 2, Subpart B. EPA recommends that applicants review the guidance in Pesticide Registration Notice (PRN) 2011-3 10 for information on how to assert this claim.



### C. Data Citation and Compensation

Existing policies and procedur es regarding data citation a nd compensation apply to the submission of data when applying to add the re pellency awareness graphic to a label. These requirements and applicable forms are fully discu ssed in Chapter 10 of the Pesticide Registration Manual (Blue Book). 11 For further reference, see FIFRA section 3(c)(1)(F) and the paragraphs on implementing regulations protecting data submitters’ rights in 40 CFR Part 152 Subpart E

.

For applicants that choose to re ly on existing data to support the addition of the graphic on their product’s labeling, EPA recommends that applic ants use the selective method of support as described in 40 CFR Part 152, Subpart E. EPA belie ves that using specific individual efficacy studies rather than citing all studies will bene fit both the applicant’s ability to calculate repellency time and the agency’s review of th e application. EPA will consider each submission based on its own merits. Applicants are encouraged to contact th e appropriate chemical manager for the product to discuss which method of cita tion might be more appr opriate in any given

situation.



### D. Human Research Ethics Considerations

New research testing the efficacy of a skin-appli ed insect repellent, conducted for the purpose of obtaining the repellency awareness graphic as described in this guidance, is subject to the requirements set forth in EPA’s rules for the pr otection of human subjects of research, 40 CFR Part 26, subparts K through Q. This type of re search would involve intentional exposure of human subjects to the test repe llent, and therefore review of th e protocol by an Institutional Review Board (IRB), by EPA, and by EPA’s Huma n Studies Review Board (HSRB) is required before study initiation. See 40 CFR § 26.1109, § 26.1125, and § 26.1601. A more thorough

10 http://www.epa.gov/PR_Notices/pr2011-3.pdf

11 http://www.epa.gov/pesticides/bluebook/chapter10.htmlSeptember 2013 

### Repellency Awareness Guidance

Page 12 discussion of these requirements can be found in the Product Performance Test Guideline,

OPPTS 810.3700. 12

If existing efficacy data are submitted or cite d for the purpose of obtaining the repellency awareness graphic, EPA will review the data for ethical acceptability unless the ethics of the study has previously been reviewed by EPA. The da ta submitter is subject to the requirements at 40 CFR § 26.1303 to provide information about the ethical conduct of the re search. Studies that involve intentional exposure of children or pregnant or nursing women will not be considered by EPA, per 40 CFR § 26.1703.



### E. Where to Send the Application

Applicants should see PRN 2006-1 13 for guidance on transmitting information to OPP.



### F. Review and Determination

Once a complete application has been receive d, OPP will conduct a review of the application. This will include the following:

1. A review of any information and data submitte d or cited for the purposes of the action.

2. A review of the applicant-submitted statistical analysis to determine the repellency time.

3. Confirmation that the formulation identified on the pesticide Confidential Statement of Formula (CSF) is substantially similar in co mposition (ingredients and percentages) to the formulation tested in the efficacy study.

4. A review of the entire product labeling.

Once the application has been reviewed, the agen cy will process the application and notify the applicant of the decision accordi ng to current agency practices.



### VII. Use of the Graphic on a Product Label and in Marketing Materials

This chapter provides recommendations for how the graphic should be displayed on a product label, including size, color, and location, and on other labeling info rmation related to the graphic. EPA also provides advice in this chapter on how to describe the graphic in marketing materials.

Use of the repellency awareness graphic is volun tary, and the recommendati ons set forth in this guidance regarding how an applicant proposes to display the graphic are non-binding and will be considered by the agency on a case-by-case basis. However, once a registrant’s label is amended to include the repellency awareness graphic a nd efficacy claim, that graphic and claim will become part of the labeling of the product, and all applicable requireme nts of FIFRA and other pesticide laws and regulations will then apply to the graphic and claim as part of the label approved by EPA under FIFRA.

12 http://www.epa.gov/ocspp/pubs/frs/publi cations/Test_Guidelines/series810.htm

13 http://www.epa.gov/PR_Notices/pr2006-1.pdf

### Repellency Awareness Guidance September 2013

Page 13 

### A. Repellency Awareness Graphic Design

The repellency awareness graphic may be used on product packaging and labeling as long as the product continues to meet the criteria for efficacy.

1. Elements of the Repellency Awareness Graphic

For product labels approved to bear the repellenc y awareness graphic, EPA recommends that the labeling contain the following elements:

 Repellency awareness graphic should be prom inently displayed on the front panel of the product label.

 Repellency awareness graphic size should be between 0.75 and 1 inch in diameter. The Repellency awareness graphic may be resized as long as it stays between 0.75 and 1 inch in diameter, but the proportions of the graphic should be maintained.

 The number of hours listed on the repellency aw areness graphic is the duration verified by the agency and is not lesser or gr eater than what the data supports.

 The repellency awareness graphic sh ould remain intact and unchanged ( e.g. , no embellishments, using portions of the graphi c, omitting wording encircling the graphic).

 The phrase “For more information on th e repellency awareness graphic, see http://www2.epa.gov/in sect-repellents ” should appear separate from the graphic but on the product label. The URL provided here will become active by the end of 2013.

 EPA recommends the phrase “This graphic repr esents typical repellency time(s)” appear on the product label in re lation to the graphic.

2. Repellency Awareness Graphic Orientation

There should be a minimum clear space “safe ar ea” of at least 0.125 inches around the graphic. No other elements should be placed within this space surrounding the graphic. For legibility, it is recommended that the graphic not be reproduce d in print smaller in width than 0.75 inches. Lettering of the repellency awareness graphic should be legible if used on the internet.September 2013 

### Repellency Awareness Guidance

Page 14 3. Repellency Awareness Graphic Color Palette

To ensure successful public rec ognition of the repellency awareness graphic, EPA recommends a uniform color palette for the graphic. The gra phic should have yellow, black, and white as its

colors.

Color Palette

RGB

Black: R 35 G 31 B 32

Yellow: R 246 G 238 B 49

White: R 255 G 255 B 255

CMYK

Black: C 70 M 67 Y 64 K 74

Yellow: C 7 M 0 Y 90 K 0

White: C 0 M 0 Y 0 K 0

4. Distribution of the Graphic to Successful Applicants

Upon successful processing of an application, EPA will notify the applicant of the decision according to current agency practices and provide instructions to successful applicants on how to retrieve the graphic.



### B. Label Language Relating to the Repellency Awareness Graphic

1. Label Language about Pests Represented in the Graphic

The label language of a product cannot conflict with information provided in the repellency awareness graphic. For example, any labeling st atements about protecti on against ticks and/or mosquitoes can only relay information identical to or consistent with what is presented in the repellency awareness graphic (if used).

As stated in Section V.C ., the most conservative ( i.e. , shortest) CPT from each of the pest group data sets should be used to represent the clai m(s) shown in the repellency awareness graphic. Specific species of a pest represented on the re pellency awareness graphic may be listed on the label, but protection times for a species, if differe nt than the time presented in the graphic, should not be listed. For example, if applying for a repe llency awareness graphic that says that ticks are repelled for “X” hours, the label can state that the product repels de er ticks, also for X hours, but should not state for Y hours, even if deer ti ck data support that dur ation. It may confuse

### Repellency Awareness Guidance September 2013

Page 15 consumers if the number of hours listed on the re pellency awareness graphic differed from the number of hours listed protecting ag ainst a specific species of tick.

2. Label Language about Pests Not Represented in the Graphic

Efficacy claims for pests not represented in the repellency awareness graphic should not be placed or worded in such a way that implies a lin k to the repellency awareness effort, if granted and placed on the label. Additionally, if any pe st not represented in the repellency awareness graphic has a repellency time less than that listed in the graphic, the repellency time for that pest should be indicated on the label. The graphic ha s the potential for causing generalizations of repellency for all pests claimed on the label, a nd indicating any pest repellency times lower than that on the repellency awareness graphic should avoid the label being misleading in that regard.

3. Vague Label Language about Efficacy of the Product

This repellency awareness effort aims to simp lify and clarify efficacy statements on insect repellent product labeling. In keeping with this goal, the agency recommends that other efficacyrelated labeling language that is vague or ineffective be removed, regardless of whether used in conjunction with the repellency awareness graphi c or not. Language of this type that is recommended for removal includes the following:

 Phrases or statements containi ng poorly defined, inexact, or confusing descriptions such

as:

o Long lasting/strong/all day/e ffective protection against [ insert pest name(s) ]

o Repels for hours

o Provides protection hour after hour

o Protects against severe conditions

 Efficacy statements containing info rmation not related to efficacy:

o Scented protection from [ insert pest name(s) ]

 Comparative efficacy claims such as:

o As good as/safer th an/better than [ insert competitor name(s) ]

4. Other Label Language Recommendations

The agency recommends that certain phrases appear on a product bearing the repellency awareness graphic, as outlined in Section V II.A.1. Labeling should not include additional statements about the repellency awareness graphic.

Regarding language not associated with the graphic itself but rela ted to protecting public health against vector-borne disease, EPA recommends other label language enhancements that include the following:

 Clearly indicate the applicati on method of the product so consumers can easily find how much product should be applied to get the protection indicated.

 Clearly distinguish if application method fo r children is different than for adults.

 Highlight the directions for use so consumer s will be drawn to the information on how to apply the product correctly.

 Remove baseless claims, such as “sweat proof” or “waterproof,” unless explicitly approved for the product by the EPA.September 2013 

### Repellency Awareness Guidance

Page 16 

### C. Other Labeling, Marketing, and Related Materials

1. Use of the Repellency Awareness Graphic on Labeling and Marketing Materials

The repellency awareness graphic may be us ed on manufacturer, di stributor, or retailer brochures, advertisements, displa ys, or point-of-purchase material s, but should only be so used where clearly associated with a specific product to indicate th at the product meets the efficacy criteria for the repellency awareness graphic. The repellency awareness graphic may also be used on manufacturer, distributor, or retailer Web sites, but should only be so used to clearly distinguish products that meet the efficacy criteri a for the repellency awareness graphic, and in direct association with those products.

The repellency awareness graphi c should not be used in a way that indicates or implies a connection with (1) products th at are not repellency awaren ess graphic-labe led, (2) entire product lines, (3) company programs in general ( e.g. , on a Web page that features several products, not all of which are labeled with the re pellency awareness graphic), or (4) promotional materials on environmental/human health in gene ral. In marketing materi als, the graphic should only be used in association with and directly adjacent to a repellency awareness graphic-labeled product.

The repellency awareness graphic should not in a ny way be used to imply that EPA endorses the product or the labeled product’s manufacturer, company, or produ cer. The repellency awareness graphic only recognizes that certain qualif ied products meet the efficacy criteria.

2. Other Materials

The repellency awareness graphi c should not be used on materi als outside of product labeling and marketing materials directly related to the repellency awar eness graphic-labeled product. Other materials related to the pr oduct or its ingredients, such as Material Safety Data Sheets, should not display the repe llency awareness graphic.



### D. Writing and Speaking About the Repellency Awareness Graphic and Effort

Successful applicants may want to mark et their product that has the graphic ( e.g. , explain what the graphic on the label means or how EPA’s re view process works). EPA recommends that successful applicants co nsult EPA’s website on repellency awareness at http://www2.epa.gov/in sect-repellents 14 for key messages about the graphic and the effort as well as for the appropriate OPP contact for any questions.



### E. Use of the Graphic without EPA Review of Data

Pesticide products, whether registered under se ction 3 of FIFRA or exempted from the requirements of FIFRA per FIFRA § 25(b), may not include any “f alse or misleading” labeling statements ( see 40 CFR § 156.10(a)(5) and 40 CFR § 152.25(f)(3)(iii)). The repellency

14 This URL will become active by the end of 2013.

### Repellency Awareness Guidance September 2013

Page 17 awareness graphic is an indicator of the duration of eff ectiveness demonstrated to the agency for the pest group(s) represented. A lthough seeking approval to use the graphic is vol untary and this guidance creates no enforcement authority in and of itself, use of this graphic, or variation thereof, without engaging the agency as reco mmended in this guidance may be “false or misleading” under 40 CFR sections 156.10(a)(5) and 152.25(f)(3)(iii) and therefore constitute “misbranding” under section 2(q)(1)(A) of FIFR A and an unlawful act under FIFRA section 12(a)(1)(F), and in the ca se of pesticides products registered under section 3 of FIFRA may also

constitute an unlawful act unde r FIFRA section 12(a)(1)(B).



### F. Terms of Use for the Repellency Awareness Graphic

For a detailed description of the registration process, please review the Pesticide Registration Manual (Blue Book). 15 All questions regarding pesticide re gistration procedures and specific registration actions should be di rected to the appropriate omb udsperson or registration liaison

listed at http://www.epa.gov/pesticides/reg ulating/contacts.htm#product

.

1. Periodic Updates of the Graphic

In the possibility that the agen cy needs to update the process or criteria for the repellency awareness effort, which affects usage of the graphic, EPA will notify users of the graphic of the update, who should then, if appropriate, submit an amendment and change their label accordingly.

2. Product Alterations

If a product that has a previously -approved repellency awareness graphic changes its formulation in a way that is not substantially similar to th e original basic Confidential Statement of Formula (CSF) approved for the product when the graphi c was added or makes other alterations which could affect the efficacy of the product, th e producer should follow existing policies and procedures for submitting information to EPA fo r an amendment to thei r product’s registration and at the same time make a new request to us e the repellency awareness graphic based on data from the altered product.

3. Termination of Use

If EPA determines that a product that has pr eviously been approved to use the repellency awareness graphic no longer qualifies for the repe llency awareness graphic, the agency will so notify the producer. The Agency expects that exis ting stocks will be handled consistent with EPA’s established “existing stocks policy” at 56 FR 29362 (June 26, 1991), as amended by 61 FR 16632 (April 16, 1996), and 40 CFR § 152.130. The repellency awareness graphic should be eliminated from promotional materials. The prod ucer should submit to the agency an application

for a label amendment that contains a new ma ster label without the repellency awareness graphic, and no new products should be produced with the repellency awareness graphic included on labeling.

15 http://www.epa.gov/pesticides/bluebook/September 2013 

### Repellency Awareness Guidance

Page 18 

### VIII. Paperwork Reduction Act Notice

As stated previously, the repellency awareness graphic will become part of a product’s labeling, and registrants should apply for use of the graphic through a new or amended registration application. Since registered products will be applying to use the graphic through existing processes, the information collection associated w ith the activities described in this document are already approved by the Office of Manageme nt and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. § 3501, et seq

.

The corresponding ICR document related to the info rmation collection activi ties associated with the application for a new or amended pestic ide registration has been approved under OMB Control No. 2070-0060 (EPA ICR No. 0277). The a nnual average reporting and recordkeeping burden for a registration applican t respondent is estimated at 14 to 840 hours, depending on the type of activity. A copy of the most recently a pproved version of EPA ICR No. 0277 is available under Docket ID No. EPA-HQ-OPP-2011-0886 at http://www.regulations.gov

.

Under the PRA, “burden” means the total time, e ffort or financial reso urces expended by persons to generate, maintain, retain or disclose or pr ovide information to or for a Federal agency. For this collection, it is the time reading the regulations, pla nning the necessary data collection activities, conducting tests, analyzing data, ge nerating reports and completing other required paperwork, and storing, filing and maintaining the data.

Under the PRA, an agency may not conduct or s ponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The appropriate OMB control number will appear on any collections of information pertaining to this guidance, including the pe sticide application.



### IX. Information Contact

For further information, please contact Rose Kyprianou of the Field and External Affairs Division (7506P), Office of Pesticide Pr ograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460- 0001; telephone number (703) 305-5354; fax number: (703) 305-5884; e-mail address: kyprianou.rose@epa.gov

.