U.S. ENVIRONMENTAL PROTECTION AGENCY
Repellency Awareness
Guidance
EPA Document No. 730-C-13-001
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September 2013
Repellency Awareness Guidance
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 Represented 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. Whereto Send the Application 12
F. Review and Determination 12
VII. Use of the Graphic on a Product Label 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 Repellency Awareness Graphic and Effort 16
E. Use of the Graphic without EPA Review of Data 16
F. Terms of Use for the Repellency Awareness Graphic 17
VIII. Paperwork Reduction Act Notice 18
IX. Information Contact 18
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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-applied insect repellent products that are
subject to the Federal Insecticide, 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 efficacy of a product against mosquitoes and/or ticks. Any other
arthropods listed on the label are not included as part of this effort 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 where predominant mosquito species
differ. The mosquito claim should be calculated using the most conservative (i.e., lowest) CPT
from all available field studies. The most conservative 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 tests on three tick species suggested in this
guidance. The tick claim should be calculated 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.
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Repellency Awareness Guidance
I. Introduction
This document presents the U.S. Environmental Protection Agency's (EPA or the agency)
guidance to industry for participation in the repellency awareness effort for one or more pesticide
products. This effort is limited to pesticide products subject to FIFRA labeled for application to
skin for the purpose of repelling mosquitoes and/or ticks. This guidance provides specific
information regarding how applicants for new registrations or registrants of currently registered
products can apply to EPA for approval to add a graphical claim to the product label. The
graphic is a standardized design 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 pesticide product label is voluntary and this guidance
creates no enforcement authority in and of itself, the inclusion of this graphic, or some variation
of this graphic, on a pesticide product label without 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 section 2(q)(l)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and an unlawful act under FIFRA section 12(a)(l)(F),
and in the case of pesticide products registered under section 3 of FIFRA may also constitute an
unlawful act under FIFRA section 12(a)(l)(B).
EPA developed this guidance document to help those who are interested in the repellency
awareness graphic to understand the types of efficacy data to provide to EPA 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 relating to the placement of the repellency awareness graphic
on the product label.
II. Background
Mosquitoes and ticks can transmit infectious diseases, including West Nile virus, Lyme disease,
and Eastern Equine Encephalitis. Using effective skin-applied insect repellent products and other
preventative actions can discourage ticks, mosquitoes, and other biting insects from landing on
you. EPA consumer research has shown that consumers believe product labels are unclear about
product effectiveness, including the repellency time.1 Consumers want clear and easy-to-find
information on product labels that conveys the types of insects2 repelled and the number of hours
of protection against those insects.
Labeling of many skin-applied insect repellent products does not currently provide easy
comparison among products when determining types of insects repelled and duration of
USEPA. 2012. Consumer Survey Results on Insect Repellent Labels.
http://www.epa.gov/pesticides/insect/repellent-consumer-survev.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.
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repellency. Thus, as part of EPA's efforts to protect public health and address consumer need for
clear pesticide labeling, EPA's Office 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 sunscreen offers against UV-B, the repellency
awareness graphic intends to make information 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 graphic to their label should consider this guidance
before contacting EPA regarding use of the graphic.
Through the repellency awareness graphic and recommendations in this guidance, the agency
intends to improve existing labels by clearly conveying to consumers the expected efficacy of
skin-applied insect repellent products, 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 and the diseases they may carry.
The graphic is product-specific based on the efficacy data supporting the product. Producers of
products subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration
requirements must submit to EPA an application for new or amended registration to use the
repellency awareness graphic as described in section VI of this guidance document. These
product applications will be subject to the Pesticide Registration Improvement Extension Act
(PRIA 3).
III. Applicability - Products for Which This Graphic is Intended
This voluntary graphic and guidance is for producers of new and existing skin-applied insect
repellent products that are subject to FIFRA registration requirements. EPA is still considering
the possible involvement of skin-applied insect repellent products that are exempt from FIFRA
requirements. These products contain minimum risk 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/biopesticides/regtools/25b list.htm. To the extent
that producers of 25(b) products become involved, participation for such a product necessarily
may differ from those products requiring registration prior to participation. The agency may
recommend that information in addition to that outlined in this guidance be submitted by a 25(b)
producer seeking to use the repellency awareness 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 seeking to use the graphic unless the producer
chooses to register their product. Therefore, at this time, EPA encourages producers of 25(b)
products to apply to register their product under FIFRA if interested in the repellency awareness
graphic.
The SPF program is administered by the Food and Drug Administration, and not EPA.
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IV. Non-binding Nature of This Guidance
This document provides EPA's general guidance to pesticide producers who may voluntarily
request to add the repellency awareness graphic to their product labeling, as well as guidance to
the public. This guidance is not binding on either EPA or any outside parties, and the EPA may
depart from the guidance where circumstances warrant without prior notice. At places in this
guidance, the agency uses the word "should." In this guidance, the use of the term "should" with
regard to an action means that the action is recommended rather than mandatory. The procedures
contained in this guidance are recommended 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 repellency awareness graphic may propose alternative
approaches to the recommendations in this guidance 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 submit 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 Safety and Pollution Prevision (OCSPP) Harmonized
Test Guidelines.4 In particular, Product Performance Test Guideline, OPPTS 810.3700: Insect
Repellents to be Applied to Human Skin5 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 characteristics of efficacy studies and other
information that EPA recommends companies provide 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 mosquitoes and/or ticks. Repellents
making claims to repel pests exclusive of mosquitoes or ticks; repellents intended for application
to animals or fabric, foliar or general surface sprays; and products intended 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 against 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. OPPTS 810.3700: Insect Repellents to be Applied to Human
Skin. EPA 712-C-10-001. http://www.epa.gov/ocspp/pubs/frs/publications/Test Guidelines/seriesSlO.htm.
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Examples of Repellency Awareness Graphics
REPELS REPELS
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 labels of registered skin-applied
insect repellent products. EPA will continue this practice in the 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 support 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 habitats where predominant mosquito species differ and preferably
cover three different genera is recommended as support for a mosquito efficacy claim for skin-
applied insect repellent products. EPA's policy is to request efficacy data that mimics, to the
extent possible, actual use conditions, in order to provide the best possible indication of
protection time for a typical consumer under environmental conditions. More information on
generating data to support a general mosquito claim can be found in Product Performance Test
Guideline, OPPTS 810.3700.6
Ticks:
For ticks, the agency has historically 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 absence 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 representative 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 representative test species
recommended to support a generalized claim against 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/publications/Test Guidelines/seriesS 10.htm.
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• Blacklegged tick (commonly 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 occurring and widespread but are the primary vectors
of several important tick borne diseases. The blacklegged tick is the primary vector of Lyme
disease, babesiosis, and anaplasmosis. The lone 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 found 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 representative test species to support a general tick claim in the repellency
awareness graphic.
C. Complete Protection Time (CPT)
Determination of CPT:
The duration of the CPT for the graphic is determined through statistical analysis of the
supporting efficacy data. The CPT is the time from application 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, OPPTS 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 claim. The agency will continue this practice
for applicants of the repellency 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 graphic. 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 protection appearing on the repellency awareness graphic should be
expressed as a whole number. If the most conservative calculated CPT is not a whole number,
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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 repellency 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 data. Inherent variability in product effectiveness
results from the interactions of factors such as differences in human behavior, host physiology
and attractiveness, variable susceptibility of pests to a product, and environmental conditions. On
this basis, EPA supports two hours as the credible minimum protection time for use of the
graphic.
VI. Implementation - How to Obtain the Graphic
Prior to contacting EPA concerning the repellency awareness graphic, EPA encourages
applicants to review all guidance and materials related to this effort. The applicant should begin
the application process only after the applicant has determined that the graphic is appropriate for
its product and has identified the information that may be needed to be considered for the
graphic. Information about the process for obtaining this graphic is provided in the following
subsections.
A. Registration Applications
This voluntary effort is intended for skin-applied insect repellent products registered under
FIFRA, and EPA views the repellency awareness graphic and the data used to support its claims
as part of a registered product's approved registration, labeling, and claims. Accordingly, the
addition of any graphic to a product's labeling, including the repellency awareness graphic, must
be requested through an application for new or amended registration under FIFRA, as amended
by the Pesticide Registration Improvement Extension Act (PRIA 3). Any information or data
pertaining to the graphic must be submitted as part of the registration application package.
The process for submitting information to EPA for a registration application package will follow
existing policies and procedures. Before making 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 meets both appropriate registration requirements and
expectations for using the repellency awareness graphic.
1. Data Items
Regulations and guidance for registering or amending a registration 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 graphic, which could ultimately involve changes to
http://www.epa.gov/PR Notices/
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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 Kit8 which contains the pertinent forms and
information needed to register or amend a registered pesticide product. In addition, the following
items should be included in an application to add the repellency awareness graphic:
• The information, data, and analyses recommended in Chapter V of this guidance.
• A proposed master label following the recommended 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 the pesticide product.
• EPA recommends that applicants also submit a cover letter with their 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 registration 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 from what is recommended in this guidance are
encouraged to contact the ombudsperson from the appropriate registering division to verify that
the data will satisfy expectations 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 pesticide applications and creates 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 evaluation process for affected pesticide decisions,
coupling the collection of individual fees with specific decision review periods. The fees and
decision review periods may change between fiscal years, and fees are periodically increased as
prescribed by statute.
PRIA 3 applications are subject 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 the type of action (e.g., new active ingredient (nonfood use), new food use,
new registration of an old product, label amendment requiring data 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 applicant must comply with any fee requirements
established under PRIA 3 in addition to the registration requirements referenced in section
http://www.epa.gov/pesticides/registrationkit/
9 http://www.epa.gov/pesticides/bluebook/
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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 appropriate 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. For 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 (CBI) 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) 2011-310 for information on how to assert this claim.
C. Data Citation and Compensation
Existing policies and procedures regarding data citation and compensation apply to the
submission of data when applying to add the repellency awareness graphic to a label. These
requirements and applicable forms are fully discussed in Chapter 10 of the Pesticide Registration
Manual (Blue Book).11 For further reference, see FIFRA section 3(c)(l)(F) and the paragraphs
on implementing regulations protecting data submitters' rights in 40 CFR Part 152 Subpart E.
For applicants that choose to rely on existing data to support the addition of the graphic on their
product's labeling, EPA recommends that applicants use the selective method of support as
described in 40 CFR Part 152, Subpart E. EPA believes that using specific individual efficacy
studies rather than citing all studies will benefit both the applicant's ability to calculate
repellency time and the agency's review of the application. EPA will consider each submission
based on its own merits. Applicants are encouraged to contact the appropriate chemical manager
for the product to discuss which method of citation might be more appropriate in any given
situation.
D. Human Research Ethics Considerations
New research testing the efficacy of a skin-applied 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 protection of human subjects of research, 40 CFR
Part 26, subparts K through Q. This type of research would involve intentional exposure of
human subjects to the test repellent, and therefore review of the protocol by an Institutional
Review Board (TRB), by EPA, and by EPA's Human 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/chapterlO.html
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discussion of these requirements can be found in the Product Performance Test Guideline,
OPPTS 810.3700.12
If existing efficacy data are submitted or cited 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 data submitter is subject to the requirements at
40 CFR § 26.1303 to provide information about the ethical conduct of the research. 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 2006-113 for guidance on transmitting information to OPP.
F. Review and Determination
Once a complete application has been received, OPP will conduct a review of the application.
This will include the following:
1. A review of any information and data submitted 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 composition (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 agency will process the application and notify the
applicant of the decision according 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 information 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 voluntary, and the recommendations 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 and efficacy claim, that graphic and claim will
become part of the labeling of the product, and all applicable requirements 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/publications/Test Guidelines/seriesSlO.htm
13 http://www.epa.gov/PR Notices/pr2006-l.pdf
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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 repellency awareness graphic, EPA recommends that the
labeling contain the following elements:
• Repellency awareness graphic should be prominently displayed on the front panel of the
product lab el.
• 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.
0.75"
• The number of hours listed on the repellency awareness graphic is the duration verified
by the agency and is not lesser or greater than what the data supports.
• The repellency awareness graphic should remain intact and unchanged (e.g., no
embellishments, using portions of the graphic, omitting wording encircling the graphic).
• The phrase "For more information on the repellency awareness graphic, see
http://www2.epa.gov/insect-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 represents typical repellency time(s)" appear
on the product label in relation to the graphic.
2. Repellency Awareness Graphic Orientation
There should be a minimum clear space "safe area" 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 reproduced in print smaller in width than 0.75 inches.
Lettering of the repellency awareness graphic should be legible if used on the internet.
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\
'i 0.125" safe area
MOSQUITO |
3. Repellency Awareness Graphic Color Palette
To ensure successful public recognition of the repellency awareness graphic, EPA recommends a
uniform color palette for the graphic. The graphic should have yellow, black, and white as its
colors.
Color Palette
RGB
Black: R35 G31 B 32
Yellow: R246 G238 B 49
White: R255 G255 B 255
CMYK
Black: C 70 M 67 Y 64 K 74
Yellow: C7 MO Y90KO
White: CO MO YO KO
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 statements about protection 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 claim(s) shown in the repellency awareness graphic.
Specific species of a pest represented on the repellency awareness graphic may be listed on the
label, but protection times for a species, if different than the time presented in the graphic, should
not be listed. For example, if applying for a repellency awareness graphic that says that ticks are
repelled for "X" hours, the label can state that the product repels deer ticks, also for X hours, but
should not state for Y hours, even if deer tick data support that duration. It may confuse
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consumers if the number of hours listed on the repellency awareness graphic differed from the
number of hours listed protecting against 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 link to the repellency awareness effort, if granted
and placed on the label. Additionally, if any pest 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 has the potential for causing generalizations of
repellency for all pests claimed on the label, and 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 simplify and clarify efficacy statements on insect
repellent product labeling. In keeping with this goal, the agency recommends that other efficacy-
related labeling language that is vague or ineffective be removed, regardless of whether used in
conjunction with the repellency awareness graphic or not. Language of this type that is
recommended for removal includes the following:
• Phrases or statements containing poorly defined, inexact, or confusing descriptions such
as:
o Long lasting/strong/all day/effective protection against [insertpest name(s)}
o Repels for hours
o Provides protection hour after hour
o Protects against severe conditions
• Efficacy statements containing information not related to efficacy:
o Scented protection from [insertpest name(s)]
• Comparative efficacy claims such as:
o As good as/safer than/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 VILA. 1. Labeling should not include additional
statements about the repellency awareness graphic.
Regarding language not associated with the graphic itself but related to protecting public health
against vector-borne disease, EPA recommends other label language enhancements that include
the following:
• Clearly indicate the application 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 for children is different than for adults.
• Highlight the directions for use so consumers 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.
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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 used on manufacturer, distributor, or retailer
brochures, advertisements, displays, or point-of-purchase materials, but should only be so used
where clearly associated with a specific product to indicate that 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 criteria for the repellency awareness graphic, and in
direct association with those products.
The repellency awareness graphic should not be used in a way that indicates or implies a
connection with (1) products that are not repellency awareness graphic-labeled, (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 repellency awareness graphic), or (4) promotional
materials on environmental/human health in general. In marketing materials, 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 any way be used to imply that EPA endorses the
product or the labeled product's manufacturer, company, or producer. The repellency awareness
graphic only recognizes that certain qualified products meet the efficacy criteria.
2. Other Materials
The repellency awareness graphic should not be used on materials outside of product labeling
and marketing materials directly related to the repellency awareness graphic-labeled product.
Other materials related to the product or its ingredients, such as Material Safety Data Sheets,
should not display the repellency awareness graphic.
D. Writing and Speaking About the Repellency Awareness Graphic and Effort
Successful applicants may want to market their product that has the graphic (e.g., explain what
the graphic on the label means or how EPA's review process works). EPA recommends that
successful applicants consult EPA's website on repellency awareness at
http://www2.epa.gov/insect-repellents14 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 section 3 of FIFRA or exempted from the
requirements of FIFRA per FIFRA § 25(b), may not include any "false 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.
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September 2013
awareness graphic is an indicator of the duration of effectiveness demonstrated to the agency for
the pest group(s) represented. Although seeking approval to use the graphic is voluntary and this
guidance creates no enforcement authority in and of itself, use of this graphic, or variation
thereof, without 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 section 2(q)(l)(A) of FIFRA and an unlawful act under FIFRA section
12(a)(l)(F), and in the case of pesticides products registered under section 3 of FIFRA may also
constitute an unlawful act under FIFRA section 12(a)(l)(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 registration procedures and specific
registration actions should be directed to the appropriate ombudsperson or registration liaison
listed at http://www.epa.gov/pesticides/regulating/contacts.htmtfproduct.
1. Periodic Updates of the Graphic
In the possibility that the agency 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 the original basic Confidential Statement of Formula
(CSF) approved for the product when the graphic was added or makes other alterations which
could affect the efficacy of the product, the producer should follow existing policies and
procedures for submitting information to EPA for an amendment to their product's registration
and at the same time make a new request to use the repellency awareness graphic based on data
from the altered product.
3. Termination of Use
If EPA determines that a product that has previously been approved to use the repellency
awareness graphic no longer qualifies for the repellency awareness graphic, the agency will so
notify the producer. The Agency expects that existing 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 producer should submit to the agency an application
for a label amendment that contains a new master label without the repellency awareness
graphic, and no new products should be produced with the repellency awareness graphic
included on labeling.
1 http://www.epa.gov/pesticides/bluebook/
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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 with the activities described in this document are
already approved by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act (PRA), 44 U.S.C. § 3501, etseq.
The corresponding ICR document related to the information collection activities associated with
the application for a new or amended pesticide registration has been approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277). The annual average reporting and recordkeeping
burden for a registration applicant respondent is estimated at 14 to 840 hours, depending on the
type of activity. A copy of the most recently approved 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, effort or financial resources expended by persons
to generate, maintain, retain or disclose or provide information to or for a Federal agency. For
this collection, it is the time reading the regulations, planning the necessary data collection
activities, conducting tests, analyzing data, generating reports and completing other required
paperwork, and storing, filing and maintaining the data.
Under the PRA, an agency may not conduct or sponsor, 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 pesticide application.
IX. Information Contact
For further information, please contact Rose Kyprianou of the Field and External Affairs
Division (7506P), Office of Pesticide Programs, 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(a),epa.gov.
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