Minimum-Risk Products 

Exempted under 40 CFR 

152.25(f) under the Authority 

FIFRA 25(b)

Kathryn BoyleField and External Affairs DivisionOffice of Pesticide Programs

Februa
Presentation Purpose 

and Agenda 

• Purpose: 

– What is the minimum risk exemption?– The 4A List– Potential changes to the exemption, R

ingredients
FIFRA Mandate

• The Federal Insecticide, Fungicide and Rodentic

(FIFRA) was enacted to manage the risks of pes

• FIFRA obligates EPA to register only those pest

that do not cause unreasonable adverse effects human health or the environment 

– EPA licenses the sale and use of pesticides 

• Public health pesticides must be effective in ord

meet the registration standard 

– EPA routinely requires efficacy data to support registra

public health pesticides such as skin applied insect re

• Labels must effectively communicate safe and 

appropriate use of the product
FIFRA Exemption

• FIFRA section 25(b) authorizes EPA 

exempt pesticides that are “of a chafor which FIFRA regulation is not req

• EPA exempted minimum risk produ

1996 under the authority of section 2

– Human and environmental exposures 

products were judged to be safe based use patterns existing in 1996

– The full text of the exemption is in 40 C

152.25(f)
Minimum Risk 

Exemption

• Minimum risk pesticide products qualify for the 

exemption by meeting the criteria specified in thof Federal Regulations at 40 CFR 152.25(f)

• This regulation specifies the active and inert ing

that may be used in minimum risk products and how these products must be labeled

– “...in the most current List 4A”

• Products must not make pesticidal claims regard

specific public health pests

• Pesticide products that do not qualify for the exe

must be licensed/registered (under FIFRA sectio
Inert Ingredient Lists

• 1987 Inert Ingredient Policy Statement

– List 1: Inert Ingredients of Toxicological Concern– List 2: Potentially Toxic Inert Ingredients/High Priority for Te– List 3: Inerts of Unknown Toxicity– List 4: Inerts of Minimal Concern

• 1989 Subdivision of List 4

– List 4A: Minimal risk inert ingredients– List 4B: Other ingredients for which EPA has sufficient 

information to reasonably conclude that the current usin pesticide products will not adversely affect public heenvironment. 
Potential Changes to 152.25(f)

for Inert Ingredients

Action:• Replace the current reference to the 4A List in 4

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

– Possible layout of table for 40 CFR 152.25(f)(2)

• CAS Reg. No. (or none)• Common chemical name/Label display name• CA Index name• Food-use• Nonfood-use

– Add a cross-reference to 40 CFR 180.950

• Changes to the codified list would be accomplis

notice and comment -- rulemaking
Possible Table 

for 152.25(f)(2)

Benzaldehyde, 4- yeshydroxy-3-methoxy121-33-5 VanillinCarbonic acid, yesmonopotassium salt

Potassium bicarbonate

298-14-6

9-Octadecenoic acid no(9Z)-, diester with 1,2,3-propanetriol

25637-84-7 Glyceryl dioleate

Common Chemical CA Index Name Food-UName/Label Display Name

CAS Reg. No.
Why a Common 

Chemical Name?

Background:• Greater specificity• Assist State inspectors • Examples of Common Chemical Names

– Citric acid 

(1,2,3-Propanetricarboxylic acid, 2-hydroxy-)

– Glyceryl dioleate

(9-Octadecenoic acid (9Z)-, diester with 1,2,3-propa

• In March 2009, OPP updated the inert ingredient list 

web) to include a common name

http://www.epa.gov/opprd001/inerts/section25b_inerts.pdf
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 common 

chemical name

– soybean oil– castor oil– rosemary oil– lemongrass oil– cedar oil– peppermint oil– citronella oil– clove oil– geranium oil– Vitamin E
Benefits

• Benefits:

– Codified tables would be a clear sourc

information for all users regarding inert ingredients acceptable for use in exemproducts

– Less confusion for the states– Purchasers would have understandabl

information concerning the ingredients products purchased
Questions?

• For additional information on these 

potential changes to 152.25(f)(2)

Kathryn BoyleBoyle.kathryn@epa.gov703.305.6304