Pesticides; Draft Guidance for Pesticide Registants on Labeling Insect Repellents

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: May 10, 2000 (Volume 65, Number 91)]
[Notices]
[Page 30113-30115]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my00-90]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00644; FRL-6495-3]


Pesticides; Draft Guidance for Pesticide Registants on Labeling
Insect Repellents

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is seeking comments on the draft Pesticide
Registration (PR) Notice regarding insect repellents labeling
restrictions for use on infants and children as well as restrictions on
food fragrances and food colors. EPA is concerned that packaging and
labeling specifically targeted to children may encourage inappropriate
handling and use of such products by children notwithstanding the lower
profile presence of label language prohibiting handling or use by
children.

DATES: Comments, identified by docket control number OPP-00644, must be
received on or before July 10, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-00644 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: Robyn Rose, Environmental Protection
Agency (7511C), 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9581; fax number: (703) 308-7026; e-mail
address: rose.robyn@epa.gov.

[[Page 30114]]

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who manufacture
and/or register products that repel insects from humans, 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
information in this notice, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of This
Document or Other Documents?

    1. Electronically. You may obtain electronic copies of this
document and the draft PR Notice from the Office of Pesticide Programs'
Home Page at http://www.epa.gov/pesticides. You can also go directly to
the listings from the EPA Internet Home Page at http://www.epa.gov. To
access this document, on the Home Page select ``Laws and Regulations''
and then look up the entry for this document under the ``Federal
Register--Environmental Documents.'' You can also go directly to the
Federal Register listings at http://www.epa.gov/fedrgstr.
    2. Fax on Demand. You may request a faxed copy of the draft
Pesticide Registration (PR) Notice entitled ``Insect Repellents:
Labeling Restrictions for Use on Infants and Children and Restrictions
on Food Fragrances and Colors,'' by using a faxphone to call (202) 401-
0527 and selecting item 6123. You may also follow the automated menu.
    3. In person. The Agency has established an official record for
this action under docket control number OPP-00644. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-00644 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC
20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6,
Suite 8, or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-00644. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want To Submit to the
Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection
activity.
    7. Make sure to submit your comments by the deadline in this
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. Background

A. What Guidance Does This Draft PR Notice Provide?

    The draft PR Notice referred to in this notice states EPA's current
position on insect repellent claims targeted for use specifically on
infants and children. Such products have typically borne statements
such as, ``Outdoor Protection for Kids'' or ``* * * for children'' or
``* * * for kids'' or graphics featuring pictures of children. EPA
believes that all claims as well as pictures of food or items
predominantly associated with infants and children (e.g., toys) may be
misleading and the Agency does not intend to approve such claims in
future registration applications. Additionally, this draft PR Notice
states EPA's current position on insect repellents formulated to
contain colors and fragrances predominantly associated with food (e.g.,
grape, watermelon, or orange). This draft PR Notice outlines the
procedure and time frame for registrants of currently registered insect
repellents with claims targeted for use specifically on infants and
children or containing

[[Page 30115]]

food colors or fragrances to make appropriate changes to product
labels. EPA believes that the label changes and policy clarification
set forth in this draft PR Notice will reduce risks associated with the
use of currently registered products and will improve consumer
understanding.

B. What Questions/Issues Should You Consider?

    Would any combination of allowing child friendly graphics, food
fragrances, or food colors increase the potential for children to want
to ingest the product? What combinations should or should not be
allowed?
    1. Labeling targeted for kids/children. (a) Should it be acceptable
to label pesticides for use on kids or any specific subset of the
population?
    (b) Do repellents labeled specifically for use on kids or children
lead consumers to believe these products were specifically formulated
for kids, safer for kids, or less effective for adults?
    (c) Should pictures of toys and objects generally associated with
children be allowed on insect repellent labels? Do these graphics lead
the consumer to believe these products are formulated to be safer or
specifically for children?
    (d) Should pictures of children without the rest of the family
(including adults) be allowed on a label?
    (e) Would graphics including an entire family on insect repellent
labels and statements such as ``For the entire family'' help clarify
who can use the product?
    2. Products formulated with food fragrances. (a) Are food
fragrances (e.g., grape, cherry, melon) in insect repellents
potentially enticing children to ingest the product?
    (b) Should the Agency allow any food fragrances in insect
repellents applied to human skin?
    (1) Should common household scents (e.g., lemon, citrus, coconut)
be acceptable?
    (2) Should non-food fragrances such as floral fragrances be
acceptable?
    (c) Could graphic depictions of food items entice children to eat
the product? Should such graphics be allowed on an insect repellent
label?
    (d) What fragrances, if any, should be acceptable in insect
repellents applied to human skin?
    3. Products formulated with food colors. (a) Should insect
repellents applied to human skin be allowed to contain colors? If so,
what colors should be allowed?
    (b) If colors are allowed, should it be allowed to refer to them by
the color rather than the food (e.g., purple rather than grape, blue
rather than blueberry)?
    (c) Will repellents formulated with food colors entice children to
eat them?
    (d) Some manufacturers believe that areas of exposed skin will be
missed when applying insect repellents. Is there a protective benefit
to incorporate colors which disappear when applied to the skin?

C. Why Is a PR Notice Guidance and Not a Rule?

    The draft PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and decision-makers, and to the public. As a
guidance document and not a rule, this policy is not binding on either
EPA or any outside parties. Although this guidance document provides a
starting point for EPA decisions, EPA will depart from this policy
where the facts or circumstances warrant. In such cases, EPA will
explain why a different course was taken. Similarly, outside parties
remain free to assert that this policy is not appropriate for a
specific pesticide or that the specific circumstances demonstrate that
this policy should be abandoned.
    EPA has stated in this notice that it will make available revised
guidance after consideration of public comment. Public comment is not
being solicited for the purpose of converting this guidance document
into a binding rule. EPA will not be codifying this policy in the Code
of Federal Regulations. EPA is soliciting public comment so that it can
make fully informed decisions regarding the content of this guidance.
    The ``revised'' guidance will not be an unalterable document. Once
a ``revised'' guidance document is issued, EPA will continue to treat
it as guidance, not a rule. Accordingly, on a case-by-case basis EPA
will decide whether it is appropriate to depart from the guidance or to
modify the overall approach in the guidance. In the course of
commenting on this guidance document, EPA would welcome comments that
specifically address how the guidance document can be structured so
that it provides meaningful guidance without imposing binding
requirements.

List of Subjects

    Environmental protection, Food coloring, Food fragrances, Insect
repellents, Labeling, Pesticides and pests.

    Dated: April 28, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-11679 Filed 5-9-00; 8:45 am]
BILLING CODE 6560-50-F
Pesticides; Draft Guidance for Pesticide Registants on Labeling Insect Repellents

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