[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66698-66700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26244]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0406; FRL-9400-2]


Pesticides; Repellency Awareness Graphic; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is seeking comment on a repellency awareness graphic for 
producers of skin-applied insect repellent products to voluntarily 
place on repellent product labels. This is part of a voluntary, ongoing 
effort to enhance public health information on, and to improve the 
clarity of, pesticide product labeling for consumers. Under this 
effort, producers of skin-applied insect repellent products can seek to 
use a standardized repellency awareness graphic that will clearly 
communicate to consumers the estimated number of hours mosquitoes and/
or ticks are repelled by a product when used as directed. With this 
notice, EPA is also seeking comment on a guidance document that 
describes the recommended criteria and processes for companies to 
voluntarily request the use of this graphic.

DATES: Comments must be received on or before March 6, 2014.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2013-0406, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-5354; fax number: (703) 305-5884; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. What is the agency's authority for taking this action?

    Sections 2 through 34 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) (7 U.S.C. 136-136y).

B. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
distribute, sell, or use skin-applied insect repellent products. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers of these products, which includes pesticide 
and other agricultural chemical manufacturers (NAICS code 325320), as 
well as other manufacturers in similar industries such as cosmetics 
(NAICS code 325620).
     Manufacturers who may also be distributors of these 
products, which includes drug and druggists' merchant wholesalers 
(NAICS code 424210).
     Retailers of skin-applied insect repellent products (some 
of which may also be manufacturers), which includes nursery, garden 
center, and farm supply stores (NAICS code 444220), supermarkets (NAICS 
code 445110), and sporting goods stores (NAICS code 451110).
     Users of skin-applied insect repellent products, including 
the general public, as well as landscaping services (NAICS code 
561730), sports and recreation institutions (NAICS code 611620), child 
daycare services (NAICS code 624410), and recreational and vacation 
camps (NAICS code 721214).

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or

[[Page 66699]]

CD-ROM the specific information that is claimed as CBI. In addition to 
one complete version of the comment that includes 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 docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Overview

    EPA is preparing to launch a new voluntary effort to enhance public 
health information and to improve the clarity of pesticide product 
labeling for consumers. Producers of skin-applied insect repellent 
products can seek to use a standardized repellency awareness graphic 
that will clearly communicate to consumers the estimated number of 
hours mosquitoes and/or ticks are repelled by the product when used as 
directed. Participation will be voluntary and has been developed for 
producers of skin-applied insect repellent products subject to FIFRA 
registration requirements.
    With this announcement, EPA is seeking public comment on the 
graphic as well as a guidance document that is intended to assist 
producers in understanding the process for requesting and obtaining 
approval for the use of the graphic (Ref. 1). Taking into consideration 
comments provided by the various stakeholders described in the 
following paragraphs, the guidance identifies the credible information 
and scientific underpinning that the Agency generally believes is 
necessary to support the information provided in the repellency 
awareness graphic. Additionally, the guidance describes for companies 
and EPA scientists a method for calculating the number of hours for the 
repellency claim(s) that would be included as part of the repellency 
awareness graphic. The guidance also describes the process for 
requesting use of the graphic through applications for new or amended 
registrations.
    EPA believes the approach to determine repellency claim(s) 
described in the guidance strikes a reasonable balance between rigorous 
testing design and cost containment. For example, some stakeholder 
comments suggested a more standardized testing methodology. While this 
may enhance consistency across tests, it would drive up costs. Since 
the objective of efficacy testing is to assess and characterize the 
general performance of each repellent rather than permit rigorous 
comparisons across products, EPA believes that the approach outlined in 
the guidance will give reasonably consistent predictions to consumers 
while ensuring that this program is affordable for companies to 
implement and flexible enough to allow for future advances in 
scientific testing methodology.
    EPA is making available information on a Web page for consumers 
(http://www.epa.gov/pesticides/insect/repellency-awareness.html) that 
describes the graphic and how to interpret as well as providing 
examples of the graphic. In the future, EPA will be launching a new, 
detailed Web page on insect repellents. The new page will include a 
list of the products approved by EPA to use the graphic on the product 
label. Additionally, the new page will provide general information to 
the public about preventative measures consumers can take to protect 
themselves and their families from mosquito and tick bites and the 
potential diseases they may transmit. When launched, the final URL for 
the program will be http://www2.epa.gov/insect-repellents.

III. Background

    The repellency awareness graphic was created in response to 
feedback obtained through focus groups and a national online survey 
conducted by EPA in 2010 and 2011, respectively (Ref. 2). During the 
focus groups and survey, consumers indicated that they wanted 
information about which types of insects are repelled and the number of 
hours those insects are repelled. Most consumers were aware that 
mosquitoes and ticks can carry potentially dangerous diseases, and they 
wanted to know how long they may be protected from those pests. 
Consumers also responded that they would like this information to be 
clear, concise, and in large print on product labels.
    EPA intends for the repellency awareness graphic to address these 
consumer needs. The repellency awareness graphic is intended to be 
displayed prominently on participating products for quick and easy 
identification by the consumer. Prototypes of this graphic were 
presented to the consumers participating in the focus groups and 
national survey, with consumers indicating that they understood the 
meaning of the information in the graphic, and that they would be 
likely to look for this graphic when shopping for skin-applied insect 
repellents (Ref. 2).
    To ensure that a variety of issues and opinions were considered 
during the development of this effort, EPA requested feedback from 
several key stakeholder groups. Starting in May 2012, EPA presented the 
concept, draft guidance document, and draft graphic to OPP's federal 
advisory committee, the Pesticide Program Dialogue Committee (PPDC), 
which represents various industry groups, non-governmental 
organizations, public health professionals, state, local, and tribal 
governments, and federal agencies (Refs. 3-5). Also beginning in May 
2012, EPA asked state regulatory officials participating in the State-
FIFRA Issues Research Evaluation Group's Pesticide Operations and 
Management (SFIREG POM) working committee for their reactions to the 
idea (Refs. 6-8). Additionally, in March 2013, EPA presented and 
received independent scientific advice from the Scientific Advisory 
Panel (SAP) on certain aspects of the effort (Ref. 9). EPA's responses 
to the SAP's comments relating to the repellency awareness graphic are 
available in the docket for this notice (Ref. 10).
    Throughout the development of this effort, EPA has also 
collaborated with experts at other federal agencies such as the Centers 
for Disease Control and Prevention (CDC) and the U.S. Department of 
Agriculture (USDA), among others. The USDA and CDC have supported EPA's 
efforts to provide clear and readily visible information about 
repellent products to consumers. The CDC has indicated that the graphic 
appears to complement their efforts to promote effective personal 
protection activities for the prevention of vector-

[[Page 66700]]

borne diseases such as West Nile virus and Lyme disease (Ref. 11).

IV. Request for Comment

    EPA is providing this opportunity for the public to provide 
comments and input on the new repellency awareness graphic before it is 
implemented. Specifically, the Agency requests comment on the 
following:
     Would addition of the repellency awareness graphic help 
you choose an insect repellent; would it improve the clarity of label 
information?
     Is the repellency awareness graphic's design, as shown on 
the program's Web page, easy to understand?
     What information would be helpful to have on our Web site 
about repellency awareness? Is the current information useful and clear 
to you?
    EPA is also seeking comment on a guidance document that describes 
the recommended criteria and processes for companies to voluntarily 
request the use of this graphic. While EPA does not intend to formally 
respond to all comments that are submitted, they will be taken into 
consideration as EPA finalizes the repellency awareness graphic and 
guidance. If substantive comments are received, EPA may, if necessary 
and appropriate, revise aspects of the graphic or the guidance. In 
addition, EPA may decide in response to any comments, to provide 
additional helpful information through the Web site.

V. References

    As indicated under ADDRESSES, a docket has been established for 
this notice under docket ID number EPA-HQ-OPP-2013-0406. The following 
is a listing of the documents that are specifically referenced in this 
action.

1. U.S. Environmental Protection Agency (EPA). Office of Pesticide 
Programs (OPP). Repellency Awareness Guidance. For Skin-Applied 
Insect Repellent Producers. August 2013. Document ID No.: 730-C-13-
001. Docket ID No.: EPA-HQ-OPP-2013-0406.
2. EPA. OPP. Insect Repellent Product Labeling Consumer Survey 
Report. April 2012. Docket ID No.: EPA-HQ-OPP-2013-0406.
3. EPA. OPP. Pesticide Program Dialogue Committee, May 3-4, 2012 
Meeting. http://www.epa.gov/pesticides/ppdc/2012/may/meeting.html.
4. EPA. OPP. Pesticide Program Dialogue Committee, November 29-30, 
2012 Meeting. http://www.epa.gov/pesticides/ppdc/2012/november/nov-mtg.html.
5. EPA. OPP. Pesticide Program Dialogue Committee, July 10-11, 2013 
Meeting. http://www.epa.gov/pesticides/ppdc/2013/july/july2013-mtg.html.
6. State-FIFRA Issues, Research, and Evaluation Group (SFIREG) 
Pesticides Operations and Management (POM) Working Committee. Final 
SFIREG POM Meeting Minutes for May 30-31, 2012. http://www.aapco.org/meetings/minutes/2012/may30/pom_mins_05_2012.pdf.
7. SFIREG POM Working Committee. Final SFIREG POM Meeting Minutes 
for September 17-18, 2012. http://www.aapco.org/meetings/minutes/2012/sep17/pom_mins_09_2012.pdf.
8. SFIREG POM Working Committee. Final SFIREG POM Meeting Minutes 
for April 22-23, 2013. http://www.aapco.org/meetings/minutes/2013/apr22/final_pom_mins_04_2013.pdf.
9. EPA. Scientific Advisory Panel (SAP). March 19-21, 2013: 
Scientific Issues Concerning the Draft Product Performance Data 
Needs Assessment for Products Claiming Efficacy Against Invertebrate 
Pests. Background documents available at Docket ID No.: EPA-HQ-OPP-
2012-0574. Additional information available at http://www.epa.gov/scipoly/sap/meetings/2013/031913meeting.html.
10. EPA. OPP. EPA Response to Scientific Advisory Panel Comments 
Related to the Proposed Repellency Awareness Graphic. September 
2013. Docket ID No. EPA-HQ-OPP-2013-0406.
11. Kyprianou, Rose. Memorandum on Federal Interagency Consultations 
During Development of the Repellency Awareness Graphic. September 
2013. Docket ID No.: EPA-HQ-OPP-2013-0406.

List of Subjects

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

    Dated: October 28, 2013.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2013-26244 Filed 11-5-13; 8:45 am]
BILLING CODE 6560-50-P