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: Recons ideration of Exemption. To help the Small Business Advocacy Review (SBAR) Panel (see Encl osure 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 feas ible, 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 conflic t 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 it ems listed above. To help support your efforts in this regard, we have enclosed informati on that may provide you with additional background

on some of the issues for discussion.

Additional materials for your review a nd 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 gu ide 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

Page 1 of 5Page 2 of 5 • List of SERs 11-17-09.pdf – a list of Small Entity Representatives

• EPA Factsheet on SERs.pdf – a document to explain you r 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 We st 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 Repelle nts 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 Exempti on 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 af fected-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 ma terial 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 sa fety objectives of the Federa l 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 copi es. To ensure that your input is received in time to be fully considered by th e SBAR Panel, I am reque sting that you provide any written comments by close of business December 15, 2009.

The SBAR Panel will consider your oral a nd 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 th ank you for investing your time and effort to help us minimize significant burdens on regulat ed small entities while achieving the public purpose to be served by regulations. I l ook forward to hearing your comments andPage 4 of 5 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 Info rmation and Regulatory Affairs

Bill Diamond, Environmental Protection Agency Director, Field and External Affairs Division, Office of Pesticide ProgramsPage 5 of 5 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 s upport the Panel’s deliberations, we have scheduled a meeting that will allow you to addr ess the Panel directly in the company of your colleagues. You may use this as the opportunity to deliver yo ur comments, or you may choose to provide written comments in lie u of, or in addition, to your or al comments. All members of the SBREFA Small Business Advocacy Review (SBA R) Panel will particip ate 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 Headquart ers, 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 a ttend 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 ha ve 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.