Pesticides; Draft Guidance for Pesticide Registants on Labeling Insect Repellents

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

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.

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 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