  

Draft Document for Public Review - EPA is releasing this draft document
solely for the purpose of public review and comment.  This draft
document is not now, and has not yet been, formally disseminated by EPA.
 It does not represent and should not be construed to represent any
Agency policy or determination.  Please submit comments to Docket ID #
EPA-HQ-OPP-2007-1008 at   HYPERLINK "http://www.regulations.gov" 
www.regulations.gov .



Draft as of: October 16, 2007

PESTICIDE REGISTRATION (PR) NOTICE 2007-X

NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS, AND REGISTRANTS OF
PESTICIDE PRODUCTS

ATTENTION: Persons Responsible for Federal Registration of Pesticide
Products

SUBJECT: Label Statements Regarding Third-Party Endorsements & Cause
Marketing Claims

This Notice contains a description of the Agency’s framework for
evaluating proposed statements and graphic material to appear on
pesticide labeling regarding third-party endorsements or a relationship
between the pesticide registrant and a charity (“cause marketing
claims”).   The Notice identifies factors EPA may consider in
reviewing applications for registration or amended registration with
labeling that contains either third-party endorsements or cause
marketing claims.  The Notice also identifies the types of discussion
and information that applicants could provide to support EPA review of
such applications.

SCOPE OF LABEL ADDITIONS POTENTIALLY AFFECTED BY THIS NOTICE

This Notice describes the framework EPA expects to use to review certain
types of labeling statements, specifically third-party endorsements and
cause marketing claims.  An applicant could potentially propose to add
such labeling statements to any type of pesticide product. For purposes
of this Notice, EPA will use the term “label statement” to refer
both to text and to any related graphical material, e.g., logos and
pictures, which would appear on the pesticide product label or elsewhere
in the product labeling.  This framework addresses: 

Label statements containing a “third-party endorsement,” e.g., an
expression of approval or a recommendation to use a product made by a
entity other than the applicant / registrant, and 

Label statements containing a “cause marketing claim,” i.e., a
statement describing a relationship (usually philanthropic) between the
registrant of the pesticide product and another entity, usually a
charity.

LEGAL FRAMEWORK

EPA regulates the sale, distribution, and use of pesticide products
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
With certain minor exceptions, every pesticide product must be
“registered” by EPA before it may lawfully be sold or distributed in
the United States.  FIFRA sec. 3(a); 12(a)(1)(A).  Under FIFRA sec.
3(c)(5), EPA may register a pesticide, i.e., approve a license
authorizing the sale and distribution of the pesticide product, if EPA
determines, among other things, that; 

 

(A) [the pesticide’s] composition is such as to warrant the proposed
claims made for it; 

(B) its labeling and other material required to be submitted comply with
the requirements of [FIFRA; and] 

(C) it will perform its intended function without unreasonable adverse
effects on the environment . . . .

The labeling of a pesticide plays a critical role in assuring the safe
use of pesticide products.  FIFRA 2(p)(1) defines the label of a
pesticide as “the written, printed, or graphic matter on, or attached
to, the pesticide or device or any of its containers or wrappers.” 
FIFRA 2(p)(2) defines “labeling” to mean “all labels and all other
written, printed or graphic matter (A) accompanying the pesticide or
device at any time; or (B) to which reference is made on the label . . .
.”  Typically, the label of a pesticide contains the product name,
brand, or trademark; an ingredients statement; a statement of net weight
or contents; directions for use; and hazard and precautionary
statements. See EPA regulations at 40 CFR part 156.

Two other sections of FIFRA relating to the labeling of pesticide
products contain important provisions that establish the link between
registration decisions and pesticide use.  Under FIFRA section
12(a)(2)(G), it is unlawful for any person “to use any registered
pesticide in a manner inconsistent with its labeling.”  To reinforce
this authority, FIFRA sec. 12(a)(2)(A) also declares it unlawful for any
person to “detach, alter, deface or destroy, in whole or in part, any
labeling required under [FIFRA]” i.e., the labeling approved as part
of EPA’s registration decision.  Thus, EPA’s registration decisions
regarding approved labeling become the primary vehicle by which EPA
establishes enforceable requirements on the use of a pesticide.

In addition, FIFRA sec. 12(a)(1)(E) prohibits the sale or distribution
of any pesticide or device which is “misbranded.”  FIFRA sec. 2 (q)
contains a lengthy definition explaining when a pesticide should be
considered misbranded, including when:

(1)(A) its labeling bears any statement, design or graphic
representation relative thereto or to its ingredients which is false or
misleading in any particular; 

. . . 

(E) any word, statement, or other information required by or under the
authority of [FIFRA] to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or graphic matter in the labeling) and
in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use; 

(F) the labeling accompanying it does not contain directions for use
which are necessary for effecting the purpose for which the product is
intended and if complied with, . . . are adequate to protect health and
the environment.

The language in FIFRA sec. 3(c)(5)(B), in effect, makes the misbranding
definition one of the criteria for determining the acceptability of a
pesticide for registration.  

EPA regulations at 40 CFR 156.10(a)(5) contain a non-exhaustive list of
10 examples of potential false and misleading claims, upon which the
proposed label statements can be judged.    The following summarizes the
examples in the regulations  and elaborates on them with language from
EPA’s Label Review Manual:

Product composition – Statements relating to the composition of a
product must be consistent with the product’s ingredient statement. 
Words or phrases implying that the product contains unique
characteristics due to its composition are not acceptable.

Product effectiveness – Claims as to the effectiveness of a product
cannot be inaccurate or exaggerated.

Statements relating to the non-pesticidal value of the product – A
label cannot bear false or misleading statements unrelated to the
pesticidal value of the product.

Comparisons to other pesticide products. 

Statements implying endorsement by a Federal agency – Phrases such as
“approved” or “recommended” used in connection with a reference
to a Federal agency are not acceptable.

Product names which suggest some, but not all of the active ingredients
in a product. 

A true statement used in a misleading manner – A label statement which
is true, but has the potential to mislead the purchaser, i.e.,
“contains all natural ingredients.”

Negating or detracting label disclaimers – an example is a claim of
benefits that are negated or contradicted by other labeling information.

Safety-related claims – Use of phrases such as “safe,”
“non-toxic,” or “harmless” that purport the product to be safe.

(j)	Comparative safety claims – such as, “Among the least toxic
chemical known” or “pollution approved” or “nonpolluting”.  

Finally, FIFRA sec. 12(a)(2)(B) makes it unlawful for any person to sell
or distribute a pesticide “if any claims made for it as a part of its
distribution or sale substantially differ from any claims made for it as
a part of the statement required in connection with its registration . .
. .”  Applicants should be aware that the Agency may consider
collateral information that substantially differs from material
submitted with an application as potentially subject to the “differing
claims” provision of section 12(a)(1)(B).  Applicants are reminded
that any collateral information related to the graphic/text should be
consistent with the information contained in the application and allowed
on the label.  OPP may periodically check such information to ensure
that it does.  Such collateral information includes, but is not limited
to:

Television advertisements

Radio advertisements

Print advertisements

Website content

e) Other advertising or solicitation (such as direct mail campaign
material or door-to-door material distribution).

In sum, to approve the addition to a pesticide label of text or graphics
conveying a third-party endorsement or cause marketing claim, EPA must
make a finding that the information is not false or misleading and does
not detract from other valuable information on the label.  If EPA cannot
make such a finding, an application to add such information cannot be
granted

III. DISCUSSION OF FACTORS AND RECOMMENDATIONS FOR SUPPORTING
INFORMATION

As explained above, the Agency will independently review an application
to add a cause marketing claim or a third party endorsement to a
pesticide label.  EPA will not approve a statement in the labeling of a
pesticide product if the statement is false or misleading or if the
presence of the statement detracts from other information required on
the labeling.  The statutory standards reflect the fundamental purpose
of FIFRA, which is to prevent unacceptable risk from the use of
pesticides.  The labeling of a pesticide product is the primary way EPA
informs users about the measures needed to prevent such risks. Thus, EPA
believes it is important to consider whether label statements may
confuse a consumer or create a distorted impression regarding the safety
or efficacy of a pesticide.

The Agency identifies below information that EPA would find useful for
its review of an application to add a cause marketing claim or
third-party endorsement to a product label.  Section A describes factors
that EPA could consider in making its decision, in particular the
potential impacts of the proposed label on consumers – and encourages
applicants to consider these factors when preparing any submissions
supporting such applications.  The Agency notes that its recommendations
do not constitute requirements.  Should an applicant not provide some or
all of the recommended information, EPA will review each submission and
make a decision based on the information available, using the Agency’s
expertise in review of pesticide labeling.  Ultimately, the applicant
has the responsibility to provide the Agency with sufficient information
to allow the Agency to make the necessary findings.  See 40 CFR Part
158.  If, upon initial review, the Agency finds that the applicant has
not met its burden, EPA might request additional information from the
applicant to facilitate further consideration of the proposal.  40 CFR
158.75.  Failure to provide requested information could lead EPA to deny
the application.  Section B discusses circumstances in which EPA might
approve the addition of a cause-marketing claim or third-party
endorsement on a condition that the registrant provide data to assess
the impact of adding such a claim.

A.  Information to support application review.

The Agency recommends that applications proposing a label statement that
is either a third-party endorsement or a cause marketing claim should
include the following information.

Mock Label.  The Agency strongly recommends that applicants submit a
realistic looking, actual size, full color mock-up of the entire label
(or labeling, if the statement does not appear on the label), containing
the proposed label statement. EPA will review each submission on a
case-by-case basis and will consider both the textual and graphical
elements of any proposed label statement. Note that EPA’s review may
determine the graphics to be unacceptable but find the related text is
acceptable, or vice versa.

The primary purpose of the mock label is to allow EPA to consider
whether the proposed label statement would mislead the user or detract
from the user’s ability to use the product safely.  For example, EPA
may consider the location of any graphics and text, as well as the size,
style, and color of the label text and graphics.  Concerns could be
raised if the graphics or text is more prominent than any other contents
of the label.  

Documentation of Third-Party Relationships.  If the label statement
contains a third-party endorsement, the Agency strongly recommends that
an applicant provide information demonstrating that the third party has
actually endorsed the product and that the label statement is consistent
with the terms of the endorsement.  For example, an applicant could
provide a letter from the third party stating that it agrees to the
proposed label statement.

Similarly, if the label statement contains a cause marketing claim, an
applicant should provide information to substantiate the truthfulness of
the claim.  For example, if the claim indicates that the registrant is
making a donation to a charitable cause, an applicant should provide a
letter from the charity confirming that the proposed label statement
regarding the donation is accurate.  The applicant should indicate the
duration of the cause marketing campaign and its relationship to the
length of time the cause marketing claim would appear on the product
label.

In addition, EPA will consider whether label statements could be
misleading.  In the case of third-party endorsement, if the label
statement indicates that it rests on the results of a survey or other
type of study, EPA encourages the applicant to provide the data from the
study.  In the case of cause marketing claims, language stating that a
donation to a charitable cause will be made for each purchase should not
be misleading in any particular, for example with respect to the amount
or specific benefits of such donation.  Misleading language about the
amount of a donation could potentially be resolved by including label
text either identifying the exact amount of money that would be given to
the charity or indicating that the donation plan is consistent with the
Better Business Bureau, Truth in Advertising/Code of Advertising
guidelines (http://www.bbb.org/) and complies with all federal, state
and local charitable solicitation statutes, regulations, and ordinances
that may affect or apply to the promotion.  

  

Discussion of Potential Consumer Impacts.  The applicant may also wish
to consider including a discussion of the potential impact of the
proposed label statement on the behavior of consumers – both people
who would consider buying the product and people who would use the
product.  For example, might the label addition confuse a consumer
thereby leading the consumer to purchase and use a product for which the
consumer had no need? Could the proposed label statement distort the
consumer’s perception of the safety of the product thereby causing a
change in the way the consumer uses the pesticide?

Such a discussion might also consider whether the proposed labeling
could have different effects on various groups of consumers, such as
consumers from different age groups, different cultural backgrounds,
people with a limited understanding of English, and people of limited
reading abilities.   How could individuals from these groups interpret
the significance of the graphics or text?   For example, do graphics
have the same meaning across cultures?  Would any of the group’s
characteristics make its members more likely to be misled?  For example,
could a graphic have a special impact on a child (e.g., a cartoon), an
individual for whom the English language is not the first language, or
an older person with impaired sight?

The discussion could address possible ways in which a consumer might
misunderstand the labeling and what consequences, if any, might flow
from that misunderstanding.  Could a third-party endorsement convey an
unwarranted impression of greater efficacy? Could a reference to a
relationship with a charity suggest that the charity endorses use of the
pesticide?  (Unless a charity explicitly wishes to endorse the product,
applicants may want to add language specifically disclaiming any
endorsement.) Could the label statement, particularly when it involves
an endorsement by a charity, create a greater perception of safety for
humans or the environment, leading the user to ignore the product’s
label directions?  What are the consequences of certain groups (e.g.
children) of being misled?  

The applicant may also wish to consider the addition of disclaimer
language to minimize any adverse consequence that could result.  If
disclaimer language is proposed, then the discussion should also address
how effectively the disclaimer mitigates the potential for
misunderstandings.  For example, it would be helpful to know whether
there are acute or chronic effects that may reasonably result from the
misinterpretation of the label and whether a disclaimer would mitigate
the misinterpretations so that the effects would be less likely.

All sections of the Discussion of Potential Consumer Impacts will
benefit from reference to (and potential submission of) studies,
surveys, and research conducted by the registrant and other
institutions.  

Consumer Market Research and Other Supporting Information. The Agency
expects that many of the potential impacts of a proposed label statement
on different groups of consumers would be fairly obvious, and that the
types of materials described above should provide adequate information
on which EPA could make a decision.  Nonetheless, in some cases, the
information may not allow EPA to evaluate the potential for adverse
impacts for some groups of consumers.  In the case of those impacts, the
applicant should consider providing additional data or information to
support any conclusions reached in the discussion of consumer impacts
regarding changes in purchasing or use behavior.  

EPA may need information to assess the validity of the impression
created by the proposed label statement.  For example, if a third-party
endorsement conveys to the user either increased efficacy or safety, EPA
may request an explanation of the basis for the third-party’s decision
to endorse the product.

EPA may also need information to assess how consumers would perceive the
proposed label statement.  While there may be a number of ways of
developing such information, one likely possibility would be the conduct
of consumer market research to ascertain how typical consumers, perhaps
from a particular subgroup, would view or respond to a proposed label
statement.  

To avoid delays in processing a label statement containing a third-party
endorsement or cause marketing claim, an applicant may wish to consider
in appropriate circumstances submitting the results of consumer market
research with the initial application.  To maximize the usefulness of
such marketing research and to increase the likelihood that it would
provide the Agency with sufficient information to assess the requested
label statement, EPA recommends that the applicant submit the proposed
research design for independent peer review.  Such peer review could be
conducted by experts in academia or at a reputable/widely-recognized
market research firm or similar organization.  The peer review should
address whether the proposed research design, including sampling
strategy, sample size, and survey questions, is appropriate for
measuring the specific impact of the label statement on consumers.  If
the applicant chooses to conduct a survey, the Agency would like to
review not only the results of the survey, but also a description of the
survey design and the results of any independent peer review.  

	B.  Data conditionally required to assess the impact of approved
claims.

EPA anticipates that it may occasionally face a situation in which a
proposed label statement appears to meet the statutory standard, but
still causes EPA some residual concern.  In such a situation, EPA could
approve a proposed label statement but conditionally require the
registrant to provide additional information to assess whether adverse
consequences resulted from the addition of the label statement.  While
there may be a number of ways of developing such information, one
possibility would be requiring the registrant to survey purchasers/users
of the product bearing the approved label statement to assess how (if at
all) their behavior changes with the pesticide containing the new label
statement.  

IV.  WHAT APPLICANTS SHOULD DO 

Addition of any graphic/text (except as described in PR Notice 98-10)
must only be done by a label amendment.  See 40 CFR 152.44 - .46. 
Addition of such language cannot be accomplished by notification or
non-notification.  

V. EFFECTIVE DATES 

[To be determined.]

VI. ADDRESSES TO USE 

Registrants should send applications to one of the following addresses: 

	U.S. Postal Service Deliveries 

The following official mailing address should be used for all
correspondence or data submissions sent to OPP by U.S. mail:

Document Processing Desk (AMEND) 

(Distribution Code as identified in PR Notice 2006-1)

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Ariel Rios Building1200 Pennsylvania Ave., NW

Washington, D.C. 20460-0001

Personal/Courier Service Deliveries

The following address should be used for all correspondence or data
submissions that are hand-carried or sent by courier service Monday
through Friday, from 8:00 AM to 4:30 PM, excluding Federal holidays:

Document Processing Desk (Distribution Code as identified in PR Notice
2006-1) (AMEND) 

Office of Pesticide Programs (7504P)

U.S. Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 South Crystal Drive

Arlington, Virginia 22202-4501

VII. SCOPE OF POLICY 

This PR Notice provides guidance to EPA and to pesticide applicants.
Although EPA encourages applicants to follow the recommendations in this
Notice, this notice is not binding on either EPA or pesticide
applicants, and EPA may depart from this guidance in individual
circumstances. Likewise, pesticide applicants may assert that the
guidance is not appropriate for a specific pesticide or situation. 

VIII. 	PAPERWORK REDUCTION ACT NOTICE 

Under the Paperwork Reduction Act (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
OMB control numbers for EPA's regulations codified in Chapter 40 of the
CFR, after appearing in the preamble of the final rule, are listed in 40
CFR part 9, are displayed either by publication in the Federal Register
or by other appropriate means, such as on the related collection
instrument or form, if applicable.  The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.  For the
ICR activity contained in this PR Notice, EPA is displaying the
applicable OMB control number in the PR Notice above, and the applicable
OMB control number also appears on the pesticide application.

The information collection activities associated with the activities
described in this PR Notice are already approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq.  The corresponding Information Collection Request
(ICR) document for pesticide applications, including the labeling
requirements for pesticides and devices, has been assigned EPA ICR
number 0277 and is approved under OMB control number 2070-0060.  The
annual average reporting and recordkeeping burden for a registration
applicant respondent are estimated to range from 14 hours to 646 hours,
depending upon the type of activity.  For “Type A” activities, which
include new active ingredients and new uses, the estimated annual
applicant burden average is 194 hours per application.  For “Type B”
activities, which include amendments and notifications, the estimated
annual applicant burden average is 14 hours per application.  The
respondent burden estimate for “Type C” reduced risk products is an
average of 646 hours per product.  

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.  

In addition to commenting on the substance of this PR Notice, EPA
welcomes your comments on the information collected related activities
and the provided burden estimates, as well as any suggested methods for
minimizing respondent burden, including the use of automated collection
techniques.  

IX. FOR FURTHER INFORMATION 

If you wish to obtain further information on this notice, please contact
the appropriate division ombudsman for your product. Division contacts,
including ombudsmen, can be found by visiting   HYPERLINK
"http://www.epa.gov/pesticides/contacts/index.htm" 
http://www.epa.gov/pesticides/contacts/index.htm .  At the release date
of this Notice, the ombudsmen are:

Biopesticides and Pollution Prevention Division (BPPD): 

Brian Steinwand    HYPERLINK "mailto:steinwand.brian@epa.gov" 
steinwand.brian@epa.gov    703-305-7973		

Registration Division (RD):

Linda Arrington    HYPERLINK "mailto:arrington.linda@epa.gov" 
arrington.linda@epa.gov      703-305-5446

Antimicrobials Division (AD):

Michael Hardy      HYPERLINK "mailto:hardy.michael@epa.gov" 
hardy.michael@epa.gov       703-308-6432

Debra Edwards, Ph. D., Director

Office of Pesticide Programs 

 PAGE   

 PAGE   10 

