Consumer Specialty Products Association (CPSA) Fruit Graphic Letter
November 13, 2002
This letter provides guidance regarding the use of graphics depicting
fruit on antimicrobial labels.
Ms. Brigid D. Klein
Consumer Specialty Products Association
900 17th Street, NW
Washington, DC 20006
Dear Ms. Klein:
This is in response to your letter of April 18, 2002 regarding the use
of graphics depicting fruit on antimicrobial labels. In your letter you
state that the California Department of Pesticide Regulation (CA DPR)
will no longer register antimicrobial products bearing graphics depicting
fruit, even if the product contains the fruit fragrance as part of its
formula. You further stated that the CA DPR decision is based on a May
25, 1999 letter to CSPA from Frank Sanders, Director of the Antimicrobials
Division (AD) which described new policies and procedures being implemented
by AD. That letter, which contained a statement "Graphic symbols
such as lemons (for lemon scent) are unacceptable", does not fully
communicate the complexity of this issue. This letter will provide guidance
regarding the use of graphics depicting fruit on antimicrobial labels.
As you are aware, the Agency has historically been concerned with the
use of food or food-like fragrances in pesticide formulations due to the
potential attractiveness to children of such product formulations containing
such fragrances. At one time, pesticide products containing food or food-like
fragrances were considered as not acceptable for registration, although
that policy was rescinded in 1993 for most pesticide products except for
insect repellants products. Insect repellant products are addressed in
PR Notice 2001-3. The result is that food or food-like fragrances are
reviewed on a case-by-case basis in products other than insect repellants.
Over the years, AD has registered a number of antimicrobial products
with formulations that contain food or food-like fragrances. However,
until very recently AD was not aware that the graphics depicting the fruit
upon which such fragrance is based were being placed on antimicrobial
labels. The draft labeling we receive, review, and, if found acceptable,
approve is typically a word processing copy and does not contain any of
the actual graphic images that actually may be intended to appear on antimicrobial
products as they are to be sold or distributed in the marketplace. Given
the importance of this issue to the Agency, the public, and the industry,
we believe we need to receive and review the actual graphics that are
intended to appear on the product as it would be sold or distributed.
In determining whether to propose placing graphics depicting fruit on
a label you should take into account the following:
Does the product contain the fragrance depicted by the graphic? If a
product does contain a fruit fragrance, then the product may be eligible
for graphics to be added using the notification process described below.
If the product does not contain a fruit fragrance, then graphics depicting
fruit likely would not be appropriate to be placed on a label because
doing so could misrepresent the product. Graphic images cannot be false
or misleading.
What is the acute toxicity profile of the product? Is the product assigned
Toxicity Category 1 by the oral, dermal or inhalation route of exposure?
If the product is assigned Toxicity Category 1 on the basis of oral, dermal
or inhalation toxicity, then the label must contain the word "Poison"
in red as well as the skull and crossbones as indicators of the high acute
toxicity of the product (40 CFR 156.10(h)(i)). We believe it would be
inappropriate to place certain graphics such as those depicting fruit
on the label due to the high acute toxicity of the product, the possible
adverse effects that could occur if children gained access to such a product,
and the potential that such graphics could distract from other important
labeling.
Will the product be packaged in child resistant packaging (CRP)? Since
we are concerned about the potential attractiveness of product formulations
containing fruit fragrances and any associated graphics depicting fruit,
a product packaged in child resistant packaging should help prevent children
from gaining access to the product. A product not in CRP is more accessible
to children .
What type of fruit graphic will appear on the label? Although the past
policy prohibiting food or food-like fragrances in pesticides formulations
has been rescinded, except for insect repellant products as discussed
earlier, the Agency is still concerned about the use of certain food or
food-like fragrances in antimicrobial products. We believe there are certain
fruits that generally should not appear on pesticide labels, i.e., fruits
that are frequently eaten by children in the form depicted such as cherries,
grapes,, watermelon slices. We believe that such fruits and thus any graphics
representing them may be inherently more attractive to children. On the
other hand, citrus fragrances and certain citrus fruit images are more
frequently associated with cleaning products. As we stated earlier in
this letter, food and food-like fragrances in products other than insect
repellants will continue to be reviewed on a case-by-case basis. Insect
repellant products are addressed in PR Notice 2001-3.
Are the graphics on the label presented in such a way as to make the
product more attractive to children, i.e., cartoon-like images, smiley
faces, and the like? If so, then the Agency would have concern that the
product attractiveness to children and thus that the potential for accidental
ingestion or other exposure could increase due to heightened product attractiveness
to children.
Please note that FIFRA Section 3(c)(9)(A) allows an antimicrobial label
to be modified "...to include relevant information on product efficacy,
product composition, container composition or design, or other characteristics
that do not relate to any pesticidal claim or pesticidal activity."
However, such modifications cannot be false or misleading, or conflict
with or detract from any statement required by law or the Administrator
as a condition of registration. We believe that the addition of fruit
graphics to a registered antimicrobial product label is subject to this
provision of FIFRA. Therefore, in accordance with this provision you must
notify the Agency in writing not later than 60 days prior to distribution
or sale of a product bearing the modified labeling including, but not
limited to, the addition of any graphic depicting fruit. A copy of the
proposed modification of the label bearing the actual proposed graphic
must be submitted with the notification. The Agency will follow section
3(c)(9)(A) - (C) in reviewing the proposed label modification.
Additionally, any new registration application which seeks registration
of a product intended to contain a food or food-like fragrance, (and is
not an insect repellant), needs to include a draft label that presents
all of the actual proposed graphics (if developed) intended to appear
on the label as the product would be sold or distributed rather than only
a word processing copy which does not include the actual intended graphics.
If graphics have not been developed at the time of submission of the registration
package, you must then use the notification process described above to
notify the Agency prior to distribution or sale of a product bearing the
modified labeling.
For existing products already in the marketplace bearing graphics depicting
fruit, companies should review their graphics using the guidance presented
in this letter. As previously stated in this letter, we believe we need
to receive and review the actual graphics that are intended to appear
on the product as it would be sold or distributed. We suggest that companies
marketing such products take appropriate steps to provide the Agency with
a copy of the label bearing the graphic material. A product could be considered
misbranded if its labeling bears any statement, design, or graphic representation
which is false or misleading or which conflict with or detract from required
labeling.
In summary, we recognize that graphics/images may, in some cases, convey
useful information to the consumer/user which is consistent with the requirements
of
FIFRA. The guidance provided in this letter should help assure that
the practice of using graphics including certain depictions of fruit can
continue under appropriate circumstances in a way that is consistent with
the purposes and requirements of FIFRA and its regulations.
Sincerely,
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Frank T. Sanders, Director
Antimicrobials Division (7510C)
cc: Barry Cortez, CA DPR
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