01-6762. 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.

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: [phone]; fax: [phone]; e-mail: [e-mail].

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 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 [phone] 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 [phone].

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.