Insect Repellents

Reconsideration of Exe

Revising the Minimum Risk Pesticide E

Remove Skin-Applied Insect Repe

Small Business Advocacy Review 

November 2009
Presentation Purpose 

and Agenda 

• Purpose: 

– To provide an overview of potential changes to the 

minimum risk pesticides that would impact skin-appproducts 

– To explain your role as a Small Entity Representati

feedback on this issue

• Agenda: 

– SER (Small Entity Representative) Guidance– EPA’s Mandate to Regulate Pesticides– Introduction to Minimum Risk Exemption under 40 – Why Re-Evaluate the Exemption for Minimum Risk 

Repellents?

– Project Goal– Small Businesses Impacted– Approaches Considered– Cost Estimates for Selected Options– Regulatory Flexibility Options for Small Entities– Attachments
What is ....?

• The term "insect repellent" is used throug

presentation in reference to products that 

inhibit, prevent, or deter the landing and bvariety of insects (including ticks). 

• The term “claim” is used to refer to statem

on the label of a pesticide product.

• The term “skin applied insect repellent” is 

insect repellents that are applied to the skbody (e.g. wrist-bands), or attached to clopatches or jewelry).
What is a SER?

• A SER (Small Entity Representative) is a r

of a small entity who may be subject to the of a proposed rule that EPA has under dev

• SERs’ participation in the rulemaking proc

ensure that EPA hears the concerns and ssmall entities.

• The Panel (EPA, SBA, & OMB) then uses 

prepare a report that includes the Panel’s recommendations on minimizing the burdeentities. The report is part of the rulemakinconsidered by Agency decisionmakers.
SER Guidance

• Your role is to help identify and explore options to minimize th

entities while still assuring the protectiveness against mosquitapplied insect repellents. For the options presented, let us knways to accomplish these goals that would cost you less.

• EPA identified marketers of skin-applied insect repellents by u

lists, information purchased from a national marketing compansearches. This included manufacturers who sell their product 

who re-pack/relabel products produced by other firms.

• We believe that you, as a group, constitute reasonable repres

producers potentially affected.

• Please attend the conference call, as possible, to facilitate info

• Please provide written comments on the topics discussed at t

within two weeks.

• See also two attached EPA fact sheets on SERs and the SBR

(attachments 1 and 2)
FIFRA Mandate

• The Federal Insecticide, Fungicide and R

(FIFRA) was enacted to manage the risks 

• FIFRA obligates EPA to register only thos

that do not cause unreasonable adverse human health or the environment 

– EPA licenses the sale and use of pesticides 

• Public health pesticides must be effective 

meet the registration standard 

– EPA routinely requires efficacy data to suppor

public health pesticides such as skin applied i

• Labels must effectively communicate safe 

appropriate use of the product
FIFRA Exemptio

• FIFRA section 25(b) authorizes 

exempt pesticides that are “of a for which FIFRA regulation is n

• EPA exempted minimum risk p

1996 under the authority of sec

– Human and environmental expos

products were judged to be safe use patterns existing in 1996

– The full text of the exemption is i

152.25(f), in attachment 3
Minimum Risk 

Exemption

• Minimum risk pesticide products qualify fo

exemption by meeting the criteria specifieof Federal Regulations at 40 CFR 152.25

• This regulation specifies the active and in

that may be used in minimum risk produchow these products must be labeled

• Products must not make pesticidal claims 

specific public health pests

• Pesticide products that do not qualify for t

must be licensed/registered (under FIFRA 
Why Re-Evaluate th

Minimum Risk Exemp

• This re-examination is prompted by

– Changes in public health hazards

• Emergence of a new mosquito-borne disea• Increased incidence of tick-borne disease

– Recognition that exempt status may b

for insect repellents because they havhealth role

– Information from States regarding com

the regulation.

– Public confusion regarding insect repe– Stakeholder requests
Public Health Hazard

• According to CDC, insect repellen

role in disease prevention

– A single bite can transmit enough inf

to cause disease.

• Since 1996, new public health con

emerged, for example: 

– Introduction in 1999 of West Nile viru

by mosquitoes.

– Increased prevalence of Lyme disea

by ticks.

– See attachments 4 & 5 for specific C

these disease trends
Lyme Disease
West Nile Virus
Recommendations 

from CDC

• “Repellents are an important tool to assist people 

themselves from mosquito-borne diseases.”

• A 2003 survey conducted by CDC and a Colorado C

Department assessed the following adult personal prof DEET repellents, long sleeves and pants, drain stato dawn exposure. The authors found that “Personamay directly influence rates of WNV infection” (GInfectious Diseases, 13 3:2007)

• The full article is included as attachment 6

• “CDC recommends using products that have bee

scientific trials and that contain active ingredients 

registered with” EPA. Use products that are regis

because EPA, before licensing each product, has 

• Safety and efficacy data supporting the product• Product label to assure that the information on the la

supporting data

• These recommendations are detailed in attachme

the CDC website
Concerns Driving EPA

Re-Evaluation

• Given the increased public health concerns, ensu

exempted skin applied insect repellent products h

Agency priority 

• Repellents that do not bear an EPA registration n

been evaluated by EPA

– EPA cannot advise consumers about the effectiven

products. 

– EPA cannot assure that exempted products provide 

from mosquitoes and ticks

• Available information indicates that many exempt 

effective than claimed on the label. 

– See attachment 8 for the 2002 article by Fradin and 

the New England Journal Of Medicine

• Soybean–based product comparable to a low concen• Citronella-based repellents protected for 20 min or le

– See also a June 2006 summary of tests by Consum

similar findings

• Four of the 18 products tested were botanicals: they 

protection scores
States’ Concerns 

• Exemption created significant enforcement concerns fo

Regions by creating a category of legal unregistered pr

– Increased regulatory burden on the States; (misbranding, 

claims)

– Difficult to determine whether a product meets the exemp

– Without a registration number, difficult to track producers 

complaints

– Lengthy case-specific process – need to find the product, 

an enforcement case. Each case takes years. 

• 37 states require registration of all pesticides – includin

exempt

– Additional burden for States to make registration decision

Federal registration

– Multiple state registration processes and requirements cr

and additional burdens for producers

• Enforcement is ineffective: 

– Easy for unscrupulous producers to dodge consequences

– Victories are transitory as manufacturers can easily re-en

slightly re-labeled product.
Potential for 

Public Confusion

• Mixed message: 

– CDC says use a registered insect repellent pr

protection against ticks and mosquitoes.

– EPA allows exempt products

• Registered and exempt products markete

– Do consumers understand the difference?– Consumers may not know that exempt produc

been tested for efficacy

• Consumers assume insect repellents that 

market are safe and work as claimed. Thpersonal risk protection decisions based assumption.
Stakeholder 

Requests

• June 2000, the American Association of Pesticide 

(AAPCO, a group of state officials) requested EPA products be exempt

• CDC consistently has opposed the exemption on 

Recommends registered products to ensure effica

• November 2004, Consumer Specialty Products A

requested better enforcement of exempt products withdraw 25(b) entirely.

• March 2006, CSPA submitted a petition to modify 

• CSPA’s petition contends that EPA is putting the 

undue risk by not requiring registration including p

products that claim to control public health pests smosquitoes and ticks. 
CSPA Petition

• Consumer Specialty Products Asso

requested that EPA:

– Initiate rulemaking to exclude from 152

pesticides that claim to control “pests opublic health importance”

– Require stability and efficacy data for a

that are to be used for public health pe

– See attachment 9 for the full text of the 

to www.regulations.gov for the petition 

comments (docket EPA-HQ-OPP-2006
EPA’s Response

• Agreed that products intended 

control of public health pests meffective

• Believe that many of the conce

expressed in the petition have that action is needed

• See attachment 10 for the full t

EPA’s response to the petition
EPA’s Goal for 

Minimum Risk 

Insect Repellents

Assure that minimum risk perso

repellent products perform eff

that users receive protection fr

or ticks that may transmit 

diseases.
Potential Phases o

EPA’s Action

At this time, EPA is focusing on insecclaiming to repel mosquitoes and ticks are applied to the skin, worn on the bowrist-bands), or attached to clothing (or jewelry).Other kinds of insect repellents such aare area repellents. While EPA is not action on these products at this time, may do so in the future.
Small Businesses 

Impacted

• Producers of minimum risk, skin-applied i

products exempted under 40 CFR 152.25potentially impacted by the upcoming reg

• EPA identified 78 such products that are 

which represent themselves as exempt frregistration, and that, according to the avinformation, meet the exemption criteria f

• These 78 products are produced by 36 co• Thirty of these companies are classified a

companies and are located in the US
Small Businesses 

Impacted (continue

• The Small Business Administration 

“small business” variably, based on category in the North American IndClassification System (NAICS)

– Variety of NAICS codes since impacte

could derive income from other producin addition to insect repellents 

– See attachment 11 for a list of industry 

definitions, and number of small entitieaffected by these changes 
Criteria for 

Evaluating Option

• Ability to ensure that skin-appli

repellents work as claimed on t

• Continued availability of effectiv

risk personal insect repellents

• Minimize costs to industry, inclu

impacts on small businesses

• Ability for States to effectively e• Sensible, workable approach
Options

• EPA has considered a range 

including: 

– Status quo– Increased enforcement– Label disclaimer– Partial exemption– Regulatory actions (section 3 re
Preliminary Screen

of Options

• Status Quo - No changes

– Doesn’t address FIFRA obligation to protect public health– Doesn’t address enforcement issues

• Enforcement - Increase efforts to enforce 25(b) regulation

products from the market; reduce instances of misleading o

– Would not eliminate ineffective exempt products– Progress is transitory because a producer can change the firm 

resume business in another state

– State resources are limited

• Label disclaimer - Label statement that EPA has not revie

– Literature review indicates that a label disclaimer will not cause 

purchasing behavior, and may not even be noticed

– See attachment 12

• Partial Exemption

– Did not achieve the objectives of assuring effective products a

issues. 

Preliminary screening of options indicates that regulatory ac

section 3 may best meet the criteria
Regulatory Option

• EPA is considering multiple regula

approaches, or licensing options, section 3

1. Remove all skin applied insect repell

exemption and require licensing usinrequirements, processes and proced

2. Require a streamlined dataset, and 

processes and procedures to supporlabel• efficacy data• product chemistry data• acute toxicity data 

3. Require only efficacy data and very 

processes and procedures
EPA’s Cost 

Estimates for Optio

• Under the remove option: 

– All skin applied insect repellents will require licensin

section 3

– Same as that for a biochemical pesticide registratio

• Under the require streamlined dataset option

– Estimated costs of conducting efficacy studies

• Efficacy test for mosquitoes (per species) -- $96K (in• Efficacy test for ticks (per species) -- $57K (includes 

– Estimated costs of conducting product chemistry st

product

– Estimated costs of conducting acute toxicity studies 

product

• Under the require only efficacy data option

– Estimated costs of conducting efficacy studies

• Efficacy test for mosquitoes (per species) -- $96K

• Efficacy test for ticks (per species) -- $57K
EPA’s Cost 

Estimates (continue

• Under licensing options, companies 

their data costs by:

– Submitting existing studies conducted 

of interest or a very similar product

– Submitting published data from open l

conducted on the product of interest oproduct

– Relying on another companies’ data, if 

very similar, though compensation of tcompany for use of its data may be ne

– Sharing costs/cooperative commission

the products are very similar
EPA’s Cost 

Estimates (continue

• Under all licensing options: oth

registration costs to consider

– PRIA fees for submissions to EP– EPA yearly maintenance fees ($3 – Company’s costs to relabel ($2 – – State registration fees ($ 100s/yr

• EPA registration does not replace t

state registrations

• States that currently do not register 

products do register all federally regproducts
Timeline

• Small Business Advocacy Revi

(SBAR Panel): through mid Jan

• Proposed Rule for public comm

planned Summer 2011
Regulatory Flexibility Opti

for Small Entities

• We would like to discuss and solicit sugg

Small Entity Representatives to identify tburdensome ways to construct the regulaalso meet our project goal.

– Your perspective on costs– Your suggestions for alternatives– Other information we should consider 

regulatory options

– Your ideas on how to make the implem

easiest for you (more workable)

– More about who you are and your bus

example, do you manufacture or re-pa
Attachments

1. Fact Sheet: What Potential Small Entity Representatives (SERs) Should Know 

Advocacy Review Panel Process (also available at http://www.epa.gov/sbrefa/docu

2. Fact Sheet: What Small Entities Should Know About Regulatory Flexibility Act 

Regulatory Enforcement Fairness Act (SBREFA) (also available at http://www.epa.gov/sbrefa/documents/sbrefaftsht2009.pdf )

3. The Minimum Risk Exemption - 152.25(f) text (also available at e-cfr http://ecfr.gpoacces4. CDC Data on Lyme Disease (also available at http://www.cdc.gov/ncidod/dvbid/Lyme/resource5. CDC Statistics on West Nile Virus6. Gujral, Zielinski-Gutierrez, LeBailly, Nasci. (2007). “Behavioral risks for West N

Colorado, 2003.” Emerging Infectious Diseases (http://www.cdc.gov/eid/content/13/3/pdf

7. a. CDC Updated Information regarding Mosquito Repellents (also available online at http://www.cdc.gov/ncidod/dvbid/westnile/resources/uprepinfo.pdf)

b. CDC Questions and Answers: Insect Repellent Use and Safety (http://www.cdc.gov/ncidod/dvbid/westnile/qa/insect_repellent.htm)

8. Fradin and Day (2002). “Comparative Efficacy of Insect Repellents Against Mo

37:13-18. (http://content.nejm.org/cgi/reprint/347/1/13.pdf)

9. CSPA Petition (also available on-line through EPA docket, which includes petition and public comm

http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPP-2006-0687)

10. EPA’s Response to the Petition (http://www.epa.gov/opp00001/biopesticides/regtools/25bpetit11. List of industrial sectors, definitions, and numbers of small entities potentially a12. Effectiveness of Label Disclaimers