UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

 OFFICE OF POLICY, 

 ECONOMICS AND INNOVATION 

November 17, 2009 

Dear Small Entity Representative (see Addressees): 

 

 Enclosed for your review and consideration is information on the forthcoming regulatory 

proposal entitled Insect Repellents: Reconsideration of Exemption. To help the Small 

Business Advocacy Review (SBAR) Panel (see Enclosure 1 below for a list of Panel members) 

understand and consider the potential effects of the draft proposed rule on small entities, we ask 

for your comments on a number of issues: 

• a description of and, where feasible, an estimate of the number of small entities to which 

the proposed rules will apply; 

• a description of projected reporting, record keeping, and other compliance requirements 

of the proposed rules, including an estimate of the classes of small entities which will be 

subject to the requirements and the type of professional skills necessary for preparation of 

the report or record; 

• an identification, to the extent practicable, of all relevant Federal rules which may 

duplicate, overlap, or conflict with the proposed rules; 

• a description of any significant alternative to the proposed rules which accomplishes the 

stated objectives of applicable statutes and which minimizes any significant economic 

impact of the proposed rules on small entities; and, 

• any impacts on small entities, such as your business or community, of the proposed rules 

or significant alternatives to the proposed rules. 

 To help the SBAR Panel understand and consider the potential effects of this draft rule on 

small entities, we ask for your comments on the items listed above. To help support your efforts 

in this regard, we have enclosed information that may provide you with additional background 

on some of the issues for discussion. 

Additional materials for your review and consideration include the following: 

• Insect Repellent SER Cover Letter 11-17-09.pdf – the document you are reading 

now 

• Minimum Risk Insect Repellent SBAR Panel Presentation 11-17-09.ppt – a 

presentation to help guide discussion on Dec. 1

• Insect Repellent SER questions 11-17-09.doc – a list of questions that the Panel 

members request you review and consider

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• List of SERs 11-17-09.pdf – a list of Small Entity Representatives

• EPA Factsheet on SERs.pdf – a document to explain your role as a Small Entity 

Representative

• EPA Factsheet on SBREFA.pdf – a document explaining the amendments to the 

Regulatory Flexibility Act

• The Minimum Risk Exemption - 152.25(f) text.pdf – exemptions currently listed 

in the Code of Federal Regulations 

• CDC data on Lyme Disease, 94-08.pdf 

• Graphs of CDC data on West Nile Virus 99-07.pdf 

• Behavioral Risks for West Nile Virus article.pdf – Emerging Infectious Diseases, 

Vol. 13, No. 3. Gujral, Zielinski-Gutierrez, LeBailly, Nasci. (2007) 

• CDC information regarding insect repellents.pdf 

• CDC website.pdf – CDC Questions and Answers: Insect Repellent Use and 

Safety 

• Comparative Efficacy of Insect Repellents Against Mosquito Bites article.pdf – 

New England Journal of Medicine, Vol. 347, No. 1. Fradin and Day (2002) 

• Petition from CSPA.pdf – Petition of the Consumer Specialty Products 

Association to Modify EPA’s Exemption from FIFRA Regulation for Minimum 

Risk Pesticides under 40 CFR § 152.25(f) 

• EPA Response to CSPA Petition.pdf 

• List of industry sectors and number of small entities affected-updated.pdf 

• Effectiveness of Label Disclaimers.pdf – review of literature on consumer use of 

label statements and findings relevant to planned action on minimum risk insect 

repellents 

Please read through as much of this outreach material as time allows. We ask that you give 

special attention to the questions in the outreach material as well as the ones referred to above. 

 On behalf of this SBAR Panel, I invite your participation in a meeting and telephone 

conference call with the Panel on December 1, 2009. Please see Enclosure 2 for meeting 

details and teleconference information. The SBAR Panel is interested in hearing your views on 

ways EPA could mitigate any adverse impact this rule might have on your business, while still 

achieving the public health and safety objectives of the Federal Insecticide, Fungicide, and 

Rodenticide Act and its amendments. 

 If you have any written comments, please send them to me in care of Caryn Muellerleile 

of my staff* and I will see that the entire SBAR Panel receives copies. To ensure that your input 

is received in time to be fully considered by the SBAR Panel, I am requesting that you provide 

any written comments by close of business December 15, 2009.

 

The SBAR Panel will consider your oral and written comments and prepare a report to 

the EPA Administrator on the potential small entity impacts of this rulemaking and on potential 

ways to reduce those impacts. 

On behalf of the Panel, I would like to thank you for investing your time and effort to 

help us minimize significant burdens on regulated small entities while achieving the public 

purpose to be served by regulations. I look forward to hearing your comments and 

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Enclosure 1 

Members of the SBAR Panel 

for 

Insect Repellents: Reconsideration of Exemption 

Alexander Cristofaro, Environmental Protection Agency 

Small Business Advocacy Chair, Office of Policy, Economics and Innovation 

Susan M. Walthall, Small Business Administration 

Acting Chief Counsel, Office of Advocacy 

Cass R. Sunstein, Office of Management and Budget 

Administrator, Office of Information and Regulatory Affairs 

Bill Diamond, Environmental Protection Agency 

Director, Field and External Affairs Division, Office of Pesticide Programs 
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 Enclosure 2 

Information on December 1, 2009 Meeting with the SBAR Panel for 

Insect Repellents: Reconsideration of Exemption 

 For your convenience, and in order to support the Panel’s deliberations, we have 

scheduled a meeting that will allow you to address the Panel directly in the company of your 

colleagues. You may use this as the opportunity to deliver your comments, or you may choose 

to provide written comments in lieu of, or in addition, to your oral comments. All members of 

the SBREFA Small Business Advocacy Review (SBAR) Panel will participate in this meeting. 

 The meeting will take place on December 1, 2009 from 12:30 – 2:30 p.m. EST in EPA 

West, conference room 4128 at EPA Headquarters, 1301 Constitution Ave, NW, Washington, 

DC. If you decide to attend in person, please be aware that we will not be able to compensate 

you for your time or travel related expenses. If you are available to attend this meeting inperson, upon entering the EPA West building on Constitution Avenue at the Federal Triangle 

Metro stop, please have the guard on duty contact my staff at 564-5480 to accompany you to the 

conference room. 

 If you are unable to attend in person, we have arranged a toll-free teleconference line for 

your convenience. The toll-free number is (866) 299-3188; the conference code is 202-566-

2372, which is entered after the operator asks for the conference code. Callers will hear music 

until the leader dials into the call. 

 Please take a moment to send an e-mail to Caryn Muellerleile 

(muellerleile.caryn@epa.gov) or call (202) 564-2855 with your RSVP information.