Minimum-Risk Produ

Exempted under 40 C

152.25(f) under the Auth

FIFRA 25(b)

Conference Call with Sta

Pesticide Regulators

February 16, 2010
Welcome

• Please send me an email:Boyle.kathryn@epa.gov
Presentation Purpose 

and Agenda 

• Purpose: 

– This is an update to the informat

at our previous call, last February

• Explain current status of the potent

repellent rulemaking

• Discuss potential changes to 152.2

– We want your feedback, especia

potential changes to the exempti

• Are these potential changes workab• Would you benefit if these potential 

became reality? 
Background

• We began in 2006 to re-evalua

health pesticide products shouexempted under 152.25(f)

• Potentially 3 Rulemakings Rel

Exempted Products 

1. Remove skin-applied insect repelle

exemption

2. Make modifications to 152.25(f), in 3. Review active ingredient list
First Project

• The workgroup is designing a targe

regulatory fix for skin-applied insect 

– We are exploring the option of register

products under FIFRA section 3

• If registration is required, we are co

what information would producers oexempted insect repellents need to EPA in an application package:

– CSF (Confidential Statement of Formu– Label– Efficacy Study– Other data?
Workgroup’s Curre

Activities 

• Completed SBREFA (Small Bu

Regulatory Enforcement FairnePanel 

• Completing the Economic Anal• Preparing for senior manageme

decisions on the proposed rule
Second Project

• In December 2008, at SFIREG, we 

changes to 152.25(f) could help you more efficiently?

• Three things we learned were:

– State inspectors need a common chem

the product

– States want the active ingredient list to 

Reg No.s, and a strict interpretation

– States want one inert ingredient list wi

distinction between the food use and n
Potential Changes 

152.25(f)

1. Require the Use of a Commo

Name on the Label

2. Redefine the List of Active Ing3. Codify the Existing List of Ine

Ingredients
Potential Change 

• Why a Common Chemical Name?

– Greater specificity– Assist State inspectors 

• Examples of Common Chemical Names

• 1,2,3-Propanetricarboxylic acid, 2-hydroxy- is c• 9-Octadecenoic acid (9Z)-, diester with 1,2,3-p

dioleate

• In March 2009, OPP updated the inert ingred

web) to include a common name

http://www.epa.gov/opprd001/inerts/section25b_

Potential Action: • In 40 CFR 152.25(f)(3) codify that the com

name, as determined by EPA, should be ingredient statement
What the Label 

Could Look Like

• Pulled from existing label

– glycine soja oil– ricinus communis seed oil– rosmarinus officinalis leaf oil– cymbopogon schoenanthus 

oil

– thuja occidentalis leaf oil– mentha piperita oil– cymbopogon nardus oil– eugenia caryophyllus flower 

oil

– geranium maculatum oil– tocopherol

• Using a co

chemical n

– soybean – castor oi– rosemary – lemongra– cedar oil– pepperm– citronella – clove oil– geranium – Vitamin E
Potential Change 2

Redefine the List of Active Ingredients• This would clarify the list of active ingredients by be

– Different process than the active ingredient list revi

• Current listings like “mint oil” and “cedar oil” are vagPotential Action: • Replace the current listing of chemical names in 40 

with more specifics

– Possible layout of table

• CAS Reg. No. (or none)• Common chemical name/Label display name• CA index name• Caveats/specifications (to be determined during a

review)
Possible Table for Act

Ingredients for 152.25(

CAS Reg. No. Common 

Chemical Name/Label Display Name 

CA Index Name 

68917-18-0 Mint oil Oils, mint, mentha 

arvensis piperascens

8008-79-5 Spearmint oil Oils, mentha 

spicata

8006-90-4 Peppermint oil Terpenes & 

terpenoids, peppermint oil 
Benefits of Redefining 

List in 152.25(f)(1)

• State inspectors could easily mat

name with the name on the label name list

• Potential for reduced follow-up fro

inspections, fewer questions and 

• Linking the CAS Reg. No., the co

and the CA Index Name maintainspecificity needed for enforcemengives the public and the inspectounderstandable information
Potential Change 3

Codify the Existing List of Inert IngredientsPotential Action:• Replace the current reference to the 4A L

152.25(f)(2) with a table similar to the one 

– Possible layout of table for 40 CFR 152.25(

• CAS Reg. No. (or none)• Common chemical name/Label display name• CA Index name• Food-use• Nonfood-use (all chemicals in the list could b

exempted products)

– Add a cross-reference to 40 CFR 180.950

• Future changes to the codified list would 

accomplished via notice and comment -- 
Possible Table 

for 152.25(f)(2)

CAS Reg. No. Common Chemical 

Name/Label Display Name

CA Index Name 

25637-84-7 Glyceryl dioleate 9-Octadecenoic acid 

(9Z)-, diester with 1,2,3-propanetriol

298-14-6 Potassium 

bicarbonate

Carbonic acid, monopotassium salt

121-33-5 Vanillin Benzaldehyde, 4- 

hydroxy-3-methoxyBenefits of Codifying 

List of Inert Ingredien

• Benefits:

– Codified tables would be a clear 

information for all users regardiningredients acceptable for use in products

– Purchasers would have understa

information concerning the ingredproducts purchased
Timeframe

• EPA expects to publish a propo

these changes at the same timproposed rule for the targeted rfix for skin-applied insect repellpublished

• Currently projected for Summe
What do you Thin

• Discussion• For additional information on th

potential changes 

Kathryn BoyleBoyle.kathryn@epa.gov703.305.6304