[Federal Register Volume 73, Number 190 (Tuesday, September 30, 2008)]
[Notices]
[Pages 56819-56824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22938]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-1008; FRL-8385-3]
Pesticides; Notice of Intent To Withdraw the Draft PR Notice on
Label Statements Regarding Third-Party Endorsements and Cause Marketing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is withdrawing its draft Pesticide Registration Notice (PR
Notice) entitled ``Label Statements Regarding Third-Party Endorsements
& Cause Marketing.'' The draft PR Notice, issued for public comment in
October 2007, contained a description of the Agency's proposed
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'') and the kinds of information EPA would expect to
receive in applications to add such claims to pesticide labeling.
Public comments on the draft raised serious issues, leading the Agency
to conclude that considerably more information would likely be needed
to support such claims than was described by the draft PR Notice.
Rather than develop additional guidance, EPA believes it is better to
allocate its resources to other initiatives which should improve
pesticide labeling in ways that enhance users' understanding of and
ability to use products safely and effectively. Thus, the Agency will
continue to evaluate applications proposing to add labeling containing
third-party endorsements or cause marketing claims on a case-by-case
basis to ensure that the applicant has provided sufficient information
to allow EPA to determine whether products containing such claims meet
the standards for registration.
FOR FURTHER INFORMATION CONTACT: Michelle DeVaux, Immediate Office
(7501P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-5891; fax number: (703) 308-4776; e-mail address:
devaux.michelle@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This notice is directed to the public in general, although it may
be of particular interest to those persons who register products under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-1008. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Background
EPA is committed to ensuring that pesticide labeling communicates
to the user information on how to use the product safely and
effectively. The Agency is devoting considerable resources to improving
the content and design of the labeling of currently approved pesticide
products in order to meet this goal. These efforts address not only
guidance about what information should appear in labeling, but also how
EPA receives and reviews labeling and how labeling is communicated to
users.
In the Federal Register of October 31, 2007 (72 FR 61638) (FRL-
8152-6), EPA issued for public comment a draft Pesticide Registration
Notice (PR Notice) entitled ``Label Statements Regarding Third-Party
Endorsements & Cause Marketing.'' The draft PR Notice described a
proposed 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 draft PR Notice also
discussed the kinds of information EPA would expect to receive in an
application in order to determine that such claims are consistent with
FIFRA. The Agency received 108 comments opposing the draft PR Notice,
along with 11 comments in support of some or all of the draft.
This Notice discusses EPA's decision, after reviewing public
comments, to withdraw its draft PR Notice, and to continue to support
initiatives that simplify and clarify labeling in order to better
communicate critical information to users. Unit III. of this Notice
describes the legal framework used by EPA to evaluate proposed labeling
of pesticide products. Unit IV. discusses the importance of pesticide
labeling and initiatives the Agency is taking to improve pesticide
labeling. Unit V. discusses the draft PR Notice and public comments
received, and Unit VI. explains EPA's position on the kinds of cause
marketing claims and third-party endorsements as described in the PR
Notice and the basis for this position.
In sum, consistent with its mandate, EPA will accept and review all
applications for new or amended pesticide labeling, including those
proposing to add third-party endorsements or cause marketing claims.
After review of public comments, however, the Agency has decided that
such claims are unlikely to
[[Page 56820]]
enhance users' ability to use a pesticide safely and effectively.
Because it does not wish to encourage such claims, EPA has decided it
is not appropriate to issue guidance on what information is needed to
support such applications. If EPA receives such an application, the
Agency expects to decide on a case-by-case basis both what information
would be sufficient to support the application and whether a product
containing such a claim would meet the applicable statutory standard
for approval.
III. 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 sections 3(a) and 12(a)(1)(A). FIFRA section
3(c)(1) requires an applicant for registration to file with EPA, among
other things, ``a statement which includes-- . . . (C) a complete copy
of the labeling, a statement of all claims to be made for [the
pesticide] . . . .'' Under FIFRA section 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 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];
(C) it will perform its intended function without unreasonable
adverse effects on the environment; and
(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable adverse
effects on the environment.
The labeling of a pesticide plays a critical role in assuring the
safe use of pesticide products. FIFRA section 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 section 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 section 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 section 12(a)(1)(E) prohibits the sale or
distribution of any pesticide or device which is ``misbranded.'' FIFRA
section 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 section 3(c)(5)(B), in effect, makes the
misbranding definition one of the criteria for determining the
acceptability of a pesticide for registration.
In summary, EPA has the authority and responsibility to register
pesticides according to specific standards, to ensure that the products
registered, when used according to the labeling, will not generally
cause unreasonable adverse effects. The importance of labeling to
convey the end results of the registration process to the user is
paramount.
IV. Registration & Labeling
In order to protect human health and the environment from
unreasonable adverse effects that might be caused by pesticides, the
Agency has developed and operates a rigorous and demanding process for
registering pesticides. The formal process begins when a manufacturer
submits an application to register a pesticide. The application must
contain required test data, including information on the pesticide's
chemistry, environmental fate, toxicity to humans and wildlife, and its
potential for human exposure. The Agency also requires a copy of the
proposed labeling, including directions for use, and appropriate
warnings. Since users are required to comply with the directions for
use and restrictions on a product's labeling, EPA uses the labeling to
define how the pesticide would be used and thus how people and the
environment would be exposed to the pesticide.
As required by FIFRA section 3(c)(4), the Agency announces the
receipt of applications for products that contain a new active
ingredient or change a use pattern and invites public comment through a
Federal Register Notice. Once an application is received, EPA processes
it and conducts an evaluation, which includes a detailed review of
scientific data to determine the potential impact on human health and
the environment. The assessment may undergo peer review by a panel of
scientific experts. The Agency considers the risk assessments and
results of any peer review, reviews risk mitigation measures, and makes
risk management and regulatory decisions.
In the decision-making process, EPA evaluates the application to
determine whether the proposed use(s) meets the Agency's standards for
human health, worker and environmental protection. If the application
does not contain enough evidence to prove that the pesticide meets all
of these standards, EPA communicates to the applicant the need for more
or better refined data, labeling modifications, or additional use
restrictions. Once the applicant has demonstrated that a proposed
product meets the statutory standards, EPA establishes a tolerance if
the product is intended to be used on food and approves the
registration with any risk mitigation necessary, and publishes the
decision in the Federal Register Notice. EPA devotes significant
resources to the regulation of pesticides to ensure the highest levels
of protection of the public and the environment.
Product labeling is the primary mechanism used by EPA to
communicate critical information to the pesticide user. The labeling
contains use directions, health and safety information, and
instructions for proper storage and disposal. Users are obligated to
follow the use instructions on the label and labeling for registered
products. Different program
[[Page 56821]]
stakeholders, including states, the Pesticide Program Dialogue
Committee, members of the Consumer Labeling Initiative, and the public,
however, have raised concerns with the current state of pesticide
labels. External stakeholder feedback has suggested that labels need to
be simpler, especially for products at the consumer level, in order for
users to fully understand them. To better communicate the required
information and to avoid distractions to the consumer, stakeholders
have suggested that EPA reduce unnecessary label content and provide
clear, concise and easy-to-read information.
In addition to stakeholder feedback on label formatting, EPA has
received input from states on the enforceability of label language.
States, as co-regulators with EPA, are responsible for enforcing many
pesticide-related laws. There are several standing venues through which
states can raise concerns to EPA; while many types of issues are
covered in these formal venues, states often raise questions on label
language on a case-by-case basis as well. When developing enforcement
cases, states often request interpretations of unclear or vague
labeling language. As a consequence of these comments, EPA is becoming
increasingly concerned about the effectiveness of labeling on currently
registered pesticides. EPA recognizes the critical role that states
play in enforcing pesticide label language and is pursuing efforts to
reduce the burden on states to continuously seek interpretations of
vague language.
EPA agrees with stakeholders that product labeling is a crucial
communications tool between EPA and the user. In recognition of the
issues raised, the Agency has supported a number of efforts to improve
labeling. These include issuing guidance on environmental hazard
general labeling statements on outdoor use products (73 FR 29503, May
21, 2008) (FRL-8362-3), labeling statements on products used for adult
mosquito control (70 FR 12881, March 16, 2005) (FRL-7695-8), labeling
of pesticide products under the National Organic Program (68 FR 10477,
March 5, 2003) (FRL-7281-6), and proposed guidance on the use of
antimicrobial pesticide products in heating, ventilation, air
conditioning and refrigeration systems (71 FR 78433, December 29, 2006)
(FRL-8108-9). Given the importance of labeling in communicating
critical safety and use information to the user, EPA will continue to
pursue improvements. Through internal reviews, EPA identified label
organization as an issue to be addressed. The Agency is working towards
using resources efficiently to effect wholesale improvements in
labeling language, content, and enforceability. The goal of these
initiatives is to simplify labels, reducing the amount of unnecessary
information, and to clarify labeling text, in order to better
communicate critical information to the user.
V. Consideration of Cause Marketing and Third-Party Claims
A. Clorox's Proposed Claims
In January 2006, The Clorox Company (Clorox) submitted an
application to EPA to add cause marketing language to the labels of
some of their registered pesticide products. The proposed language
described a philanthropic relationship between Clorox and the American
Red Cross (Red Cross). In a meeting between EPA and Clorox in March
2006, Clorox described the partnership agreement into which they had
entered with the Red Cross, discussed what cause marketing language
they were currently using on non-pesticide products, and presented a
label mock-up for an antimicrobial bleach product. In this meeting, EPA
expressed concern that consumers might interpret the Red Cross symbol
on the label as an implied safety claim. Clorox provided an additional
presentation in July 2006, which included a toxicological profile of
bleach; a National Capital Area Poison Control Center presentation
regarding incidents involving bleach; and information from a consumer
survey indicating that the labeling would not alter consumer behavior
in ways that could lead to misuse.
After review of the information described above, EPA approved Red
Cross cause marketing claim language on the label of certain Clorox
products. The decision particularly relied on EPA's expectation, which
was based on the consumer survey research, that consumers would not
interpret the Red Cross symbol on labels to mean that the product was
safe. The decision also relied on an assessment of the likely health
consequences were the products to be misused as a result of the
presence of the cause marketing labeling and consideration of whether
such labeling would alter consumer behavior in ways that could lead to
misuse. EPA concluded that this information was sufficient to support a
conclusion that the product bearing the cause marketing language would
not be ``misbranded'' under FIFRA.
B. Post-Approval Activity
After EPA's decision to approve Clorox's application to add the
cause marketing claim became widely known, a number of organizations
expressed their opposition to the specific decision and to any general
policy that would allow cause marketing claims on the labeling of
pesticide products. The groups opposing the Red Cross claim on Clorox
labels included the Association of American Pesticide Control
Officials, Beyond Pesticides, Pesticide Action Network North America,
Center for Environmental Health, American Bird Conservancy, Pesticide
Education Project, Strategic Counsel on Corporate Responsibility,
Environmental Health Fund, the Endocrine Disruption Exchange, and
Northwest Coalition for Alternatives to Pesticides, as well as
Attorneys General in six states. In April 2007, the Minnesota
Department of Agriculture refused to accept Clorox products with the
Red Cross charity labels for distribution in Minnesota.
This topic was discussed by the Pesticide Program Dialogue
Committee (PPDC) in May 2007, and in meetings with various other
stakeholder groups. The PPDC, established under the Federal Advisory
Committee Act, consists of a diverse group of stakeholders and provides
an opportunity for feedback to the Agency's pesticide program on
various pesticide regulatory, policy, and program implementation
issues. Comments from the PPDC members were divided; some spoke in
support of EPA's decision, but others expressed strong objections. See
http://www.epa.gov/pesticides/ppdc/2007/may2007/may2007.htm.
C. Proposed Pesticide Registration (PR) Notice
The Agency developed a proposed framework and guidelines for
evaluating requests to add cause marketing claims and third-party
endorsements to pesticide labeling. EPA proposed that, at a minimum,
the labeling of a registered product must be effective in providing
both use instructions and necessary safety information. The Agency
issued a draft PR Notice for comment on October 31, 2007 (72 FR 61638).
The draft PR Notice defined what the Agency considered cause marketing
claims (``a statement describing a relationship (usually philanthropic)
between the registrant of the pesticide product and another entity,
usually a charity'') and third-party endorsements (``an expression of
approval or a recommendation to use a product made by an entity other
than the applicant/registrant'').
The legal framework of the PR Notice rested primarily on the
requirement that EPA determine that proposed pesticide
[[Page 56822]]
labeling would not be misbranded under FIFRA. Recommendations for data
to be submitted for consideration included mock labels, documentation
of the relationship between the registrant and charity or third-party
endorser, discussion of potential consumer impacts, consumer market
research, disclaimer language to minimize misunderstanding by
consumers, and other supporting information. The intent of the PR
notice was to set a high bar for consideration of claims that may have
a higher likelihood to be considered false or misleading, or as
detracting from use directions or other important information on the
label or labeling. The proposed guidance outlined how applicants or
registrants could demonstrate that the proposed language and logos did
not distract from safe use instructions or violate the misbranding
standard.
D. Public Comments on the PR Notice
EPA received a total of 119 comments on the draft PR Notice. Along
with other background information, the comments appear in the public
docket for this action: EPA-HQ-OPP-2007-1008. Of those, 108 opposed the
draft PR Notice and 11 supported some or all of the components of the
draft PR Notice. The following is a summary of the comments received.
1. Opposition. Those opposed to the PR Notice argued that labels
should be used only to convey use instructions and safety information,
not unnecessary endorsements or logos. They also noted that the labels
of many (if not most) products are already crowded, and additional
information would take space away or distract from elements required by
statute and regulation. These claims would be designed to draw
consumers' attention, potentially distracting them from the important
health and safety information and undermining the protections
implemented through label requirements. Commenters also asserted that
EPA should not become involved in corporate marketing, which falls
outside the Agency's mission of protecting human health and the
environment and providing information on labeling to assist with the
safe use of pesticide products. Since space on labels is limited, these
comments urged EPA to refuse to allow extraneous information that is
not needed for product identification, directions for use, or other
text that minimizes risk and maximizes efficacy.
Some commenters also opposed the PR Notice because they believe
that logos and claims are inherently misleading, i.e., that they imply
safety claims or greater efficacy for a product. Commenters cited the
FIFRA definition of misbranding (section 2(q)(1)(A)), claiming that,
under this provision, cause marketing statements or third-party
endorsements are inherently misleading. In addition, they cited 40 CFR
156.10(a)(5)(iii) which states that false and misleading statements
include ones ``about the value of the product other than as a pesticide
or device,'' which could be implied by a cause marketing claim or
third-party endorsement. Commenters argued that consumers may interpret
the logo of an organization they trust or from a celebrity as an
implied endorsement. In addition, they argued that vulnerable
populations such as elderly people, those with low literacy, and
children may rely on the logo as the primary selection criteria,
regardless of the intended use of the product.
As discussed above, EPA devotes significant resources to evaluation
of labels and labeling and registration of products. Commenters argued
that the additional level of review necessary to evaluate a cause
marketing claim or third-party endorsement would divert Agency
resources from evaluations of more important elements of the label and
labeling required by the statute and regulation. The comments made a
similar argument with respect to the allocation of resources in
enforcement programs. Commenters argued that the resources of the
Agency's pesticide program should not be diverted from the fundamental
mission of protecting public health and the environment to evaluate
claims that are designed as marketing or fundraising campaigns.
Commenters also asserted that the draft PR Notice conflicted with
EPA's Label Review Manual (http://www.epa.gov/oppfead1/labeling/lrm/),
a policy document on label and labeling content that uses the Red Cross
logo as an example of a symbol that implies safety or non-toxicity, and
could be considered false or misleading. They requested that the
existing policy be followed. At the least, before accepting claims that
could be viewed as inconsistent with the Label Review Manual and that
could potentially endanger public health, commenters requested more
demonstration of the expected public benefit and an explanation of why
a change would be necessary.
Some commenters in opposition argued that the information EPA
proposed to require would contain insufficient detail to allow the
Agency to evaluate an application with a cause marketing claim or
third-party endorsement. These commenters recommended that EPA provide
more specific guidance, or implement requirements, for applicants to
ensure that the information provided would prove the absence of any
implied endorsement and false or misleading claims. They also suggested
that information should be required to prove that the proposed cause
marketing claim or third-party endorsement would not detract or
distract from the required labeling elements.
Lastly, some commenters opposed the proposal because EPA decisions
to allow cause marketing claims and third-party endorsements could
conflict with states' decisions. They believed that there was
insufficient meaningful consultation with the states through the State
FIFRA Issues Research and Evaluation Group. Allowing these types of
claims could make the Federal standard more lenient than some state
regulations, and could prevent states from denying registration of
these products if they find a risk concern.
2. Support. Comments in support of the draft PR Notice fell into
two categories. One group recommended that EPA limit the scope of the
draft PR Notice only to cause marketing claims and that EPA should
issue a final PR Notice with only modest changes to the draft. As for
third-party endorsements, these comments recommended that EPA establish
a public engagement process for further consideration of the issues
raised by such labeling. The other group supported changing the
emphasis of the PR Notice to focus on third-party endorsements from
established organizations and environmentally preferable or ``green''
certification programs.
Those who supported approving the PR Notice for cause marketing
claims argued that this type of claim should be held to the same
standards as any other non-FIFRA text added to the label. They asserted
that no additional information (beyond the current requirements) should
be necessary unless there is a concern that the cause marketing claim
could have an implied safety message. In a similar vein, they stated
that additional publicengagement--beyond what FIFRA mandates--would be
unnecessary and improper, because the public and states are not
currently involved in registration decisions and it would be improper
to engage outside stakeholders in the case of cause marketing claims.
Another group of comments expressed support for the draft PR Notice
because it would make the inclusion of third-party endorsements in
pesticide labeling more likely. These comments argued that there is an
Agency precedent for allowing certain
[[Page 56823]]
logos or endorsements on labels. Specifically, endorsements by the
Organic Material Review Institute and the Soil and Mulch Council were
cited. They also proposed that approving standards established by
third-party certification programs such as Design for the Environment
and Green Seal would alleviate burden on EPA during the application
review process while providing information to consumers to assist them
in differentiating between products based on environmental, efficacy-
based and other quantitative characteristics.
VI. Agency Action
The Agency has decided to withdraw the PR Notice describing
framework for evaluating cause marketing claims or third-party
endorsements. After reviewing public comments, the Agency agrees that
cause marketing claims and third-party endorsements as outlined in the
draft PR Notice generally would not contribute meaningfully to
improving protection of human health and the environment. The addition
of such statements is not likely to enhance users' ability to
understand the labeling required to inform the user about how to use
the product safely and effectively. In fact, the addition of such
statements could interfere with that goal. In addition, EPA recognizes
that its resources are limited and should be targeted towards
activities that will enhance the level of protection of human health
and the environment from pesticides. Thus, although EPA will review any
future application it receives, it generally discourages the submission
of applications to add cause marketing claims or third-party
endorsements.
In reviewing the legal framework on which the PR Notice was based,
the Agency concluded that FIFRA and its implementing regulations do not
explicitly prohibit the inclusion of cause marketing claims or third-
party endorsements in labeling, nor do they differentiate between the
two types of claims. Therefore, EPA will continue to review and make
decisions on applications to for new or amended pesticide labeling
using the standards in FIFRA section 3(c)(5)(A)-(D). Consistent with
existing policy, EPA will not approve a statement in the labeling of a
pesticide product unless the applicant can demonstrate that the
statement is not false or misleading and that the presence of the
statement detracts from other information required on the labeling.
If EPA receives applications to add such labeling to product
labeling, EPA will decide on a case-by-case basis what types of
information would be necessary to allow the Agency to evaluate such an
application. In recognition of concerns about such claims' potential
impact on public health and their potential burden on EPA resources,
the Agency will expect applicants to supply a complete justification to
support the proposed additions. While it is difficult for the Agency to
identify the exact types of information it will need in every
circumstance, applicants should understand that they must submit
sufficient information to allow the Agency to determine that the
desired statements will not mislead pesticide users, especially
vulnerable subpopulations, and will not detract from other important
language on the label. 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
may 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.
The Agency will also review and decide on a case-by-case basis
whether to approve such applications. As indicated above, the legal
standards for such reviews appear in FIFRA section 3(c)(5), as informed
by the definition of ``misbranding'' in FIFRA section 2(q). Also, as
discussed above, product labeling plays a critical role in the
effective regulation of pesticides, and the Agency thinks clear,
simple, and enforceable labeling is essential to ensuring pesticides do
not cause unreasonable adverse effects on the environment. Since most
cause marketing claims or third-party endorsements ordinarily do not
provide information that contributes to the safe and effective use of a
pesticide, EPA will approve applications to add cause marketing claims
or third-party endorsements only if the applicant provides information
to show that the inclusion of such text will neither create a
misleading impression in any significant subgroup of the population of
people who might use or otherwise come into contact with the product
nor interfere with the ability of people who use the product to
understand how to use the product properly. The decision about whether
to approve the proposed addition of such labeling text would likely
depend on the proposed content and placement of the text, the nature of
the existing labeling, and the potential risks associated with the use
of the pesticide, among other characteristics. EPA expects that, in
general, it would be difficult to convince EPA to approve applications
to add most types of cause-marketing claims or third-party
endorsements.
Based on the experience with the cause marketing claim proposed by
Clorox, EPA expects that there would be a high level of public concern
about future requests for consideration of such claims. Given the
controversial and complicated nature of these types of claims, EPA
believes it would benefit from consultation with states and a public
comment period. Although it has not been historical practice, if EPA
receives applications to add cause marketing claims or third-party
endorsements that have enough information to support the approval of
such a claim, it would likely offer its state partners, as well as the
public, an opportunity to comment. Any public engagement would be
conducted in a manner consistent with FIFRA requirements to protect
Confidential Business Information (CBI).
In light of the significant interest in improving users'
understanding of and ability to use products safely and effectively,
EPA agrees with public comments that comparative safety statements, or
``green labeling,'' on pesticide labels should be further considered as
a tool. Companies have found that consumers are interested in having
labeling on products indicating that the products meet a specific set
of criteria, for example that they are safer or environmentally
preferable according to a specific standard. Programs to set standards
for such green labeling include: Energy Star, Design for the
Environment, and Green Seal. Experience also suggests that some
consumers will alter their behavior to use products bearing such green
labeling.
As a first step, the Office of Pesticide Programs will engage a
work group under the Pesticide Program Dialogue Committee on
comparative safety statements or logos for pesticide product labeling.
This work group will address interest being expressed by the public for
possible development of Agency or third-party standards regarding
comparative product safety. The work group will make recommendations to
the full Pesticide Program Dialogue Committee as to whether the
government should pursue revision of the current regulations at 40 CFR
156.10(a)(5) in order to develop or allow these types of statements or
logos.
EPA anticipates that these types of comparative safety statements
would be
[[Page 56824]]
used by consumers as tools, to assist them in differentiating between
similar types of products based on distinct, verifiable criteria. For
example, a logo from the National Organic Standards Board could assist
a grower seeking to obtain or maintain organic certification for his/
her farm. Labels could provide information about the comparative safety
of the product as well as about its potential environmental impact,
allowing consumers to choose among products based on their preferences.
Along with the recommendations from the PPDC work group, EPA will
consider the potential risks associated with including these types of
statements on pesticide labeling and the proper role of government in
this type of program before deciding whether or not to revise the
current regulations.
In summary, the Agency is committed to ensuring that pesticide
labeling is utilized as a tool to communicate critical information to
the user how to use the product safely and effectively. In order to
ensure that protection of public health and the environment remain the
top priorities for EPA, we are not encouraging submissions of any label
claims that detract or distract from the use and safety instructions or
that could be considered false or misleading. We remain committed to
programs and initiatives designed to improve the content, organization
and enforceability of pesticide labeling.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: September 24, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E8-22938 Filed 9-29-08; 8:45 am]
BILLING CODE 6560-50-S