[Federal Register Volume 66, Number 55 (Wednesday, March 21, 2001)]
[Notices]
[Pages 15868-15869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6762]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00692; FRL-6759-9]


Guidance for Pesticide Registrants on Insect Repellents: Labeling 
Restrictions for Use on Infants and Children and Restrictions on Food 
Fragrances and Colors; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY:  This notice announces the availability of a Pesticide 
Registration (PR) Notice and a Response to Public Comments document. 
The PR Notice outlines EPA's policy on insect repellents bearing claims 
for use specifically on infants and children and provides guidance to 
EPA personnel and decision-makers, members of the regulated community, 
and to the public. EPA believes that the label changes and policy 
clarification set forth in the PR Notice will reduce risks associated 
with the improper use of insect repellents and will improve consumer 
understanding. Additionally, the PR Notice states EPA's current 
position on insect repellents formulated to contain colors and 
fragrances predominantly associated with food (e.g., grape, orange, or 
watermelon).

FOR FURTHER INFORMATION CONTACT:  Robyn Rose, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460. Office telephone 
number: (703) 308-9581; fax: (703) 308-7026; e-mail: 
[email protected].

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 and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document and the PR Notice from the Office of

[[Page 15869]]

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,'' `` Regulations and Proposed Rules,'' 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 Pesticide 
Registration (PR) Notice titled ``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 6134. Select 6135 to request a copy of the Response to 
Public Comments document. 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-00692. 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.

II. Background

A. What Guidance Does this PR Notice Provide?

    The 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 sometimes 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 expect to approve such claims in 
future registration applications. Additionally, the PR Notice states 
EPA's current position on insect repellents formulated to contain 
colors and fragrances predominantly associated with food (e.g., grape, 
orange, or watermelon). The 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 food colors or fragrances to make appropriate changes to 
product labels. EPA believes that the label changes and policy 
clarification set forth in the PR Notice will reduce risks associated 
with the use of currently registered products and will improve consumer 
understanding.

B. PR Notices are Guidance Documents

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decision-makers and to pesticide 
registrants. This notice is not binding on either EPA or pesticide 
registrants, and EPA may depart from the guidance where circumstances 
warrant and without prior notice. Likewise, pesticide registrants may 
assert that the guidance is not appropriate generally or not applicable 
to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.


    Dated: January 16, 2001.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

[FR Doc. 01-6762 Filed 3-20-01; 8:45 am]
BILLING CODE 6560-50-S