1Minimum-Risk ProductsExempted under 40 CFR152.25(f) under the Authority ofFIFRA 25(b)Kathryn BoyleField and External Affairs DivisionOffice of Pesticide ProgramsFebruary 3, 20102Presentation Purposeand Agenda• Purpose:– What is the minimum risk exemption?– The 4A List– Potential changes to the exemption, RE: inertingredients3FIFRA Mandate• The Federal Insecticide, Fungicide and Rodenticide Act(FIFRA) was enacted to manage the risks of pesticides.• FIFRA obligates EPA to register only those pesticidesthat do not cause unreasonable adverse effects onhuman health or the environment– EPA licenses the sale and use of pesticides• Public health pesticides must be effective in order tomeet the registration standard– EPA routinely requires efficacydata to support registration ofpublic health pesticides such as skin applied insect repellents• Labels must effectively communicate safe andappropriate use of the product4FIFRA Exemption• FIFRA section 25(b) authorizes EPA toexempt pesticides that are “of a character”for which FIFRA regulation is not required• EPA exempted minimum risk products in1996 under the authority of section 25(b)– Human and environmental exposures to theseproducts were judged to be safe based on theuse patterns existing in 1996– The full text of the exemption is in 40 CFR152.25(f)5Minimum RiskExemption• Minimum risk pesticide products qualify for theexemption by meeting the criteria specified in the Codeof Federal Regulations at 40 CFR 152.25(f)• This regulation specifies the active and inert ingredientsthat may be used in minimum risk products and specifieshow these products must be labeled– “...in the most current List 4A”• Products must not make pesticidal claims regardingspecific public health pests• Pesticide products that do not qualify for the exemptionmust be licensed/registered (under FIFRA section 3)6Inert Ingredient Lists• 1987 Inert Ingredient Policy Statement– List 1: Inert Ingredients of Toxicological Concern– List 2: Potentially Toxic Inert Ingredients/High Priority for Testing– 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 sufficientinformation to reasonably conclude that the current use patternin pesticide products will not adversely affect public health or theenvironment.7Potential Changes to 152.25(f)for Inert IngredientsAction:• Replace the current reference to the 4A List in 40 CFR152.25(f)(2) with a table similar to the one on the internet–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 accomplished vianotice and comment -- rulemaking8Possible Tablefor 152.25(f)(2)yesBenzaldehyde, 4-hydroxy-3-methoxyVanillin121-33-5yesCarbonic acid,monopotassium saltPotassiumbicarbonate298-14-6no9-Octadecenoic acid(9Z)-, diester with1,2,3-propanetriolGlyceryl dioleate25637-84-7Food-Use?CA Index NameCommon ChemicalName/LabelDisplay NameCAS Reg. No.9Why a CommonChemical 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-propanetriol)• In March 2009, OPP updated the inert ingredient list (on theweb) to include a common namehttp://www.epa.gov/opprd001/inerts/section25b_inerts.pdf10What the LabelCould Look Like• Pulled from existing label– glycine soja oil– ricinus communis seed oil– rosmarinus officinalis leaf oil– cymbopogon schoenanthusoil– thuja occidentalis leaf oil– mentha piperita oil– cymbopogon nardus oil– eugenia caryophyllus floweroil– geranium maculatum oil– tocopherol• Using a commonchemical name– soybean oil– castor oil– rosemary oil– lemongrass oil– cedar oil– peppermint oil– citronella oil– clove oil– geranium oil– Vitamin E11Benefits• Benefits:– Codified tables would be a clear source ofinformation for all users regarding inertingredients acceptable for use in exemptedproducts– Less confusion for the states– Purchasers would have understandableinformation concerning the ingredients in theproducts purchased12Questions?• For additional information on thesepotential changes to 152.25(f)(2)Kathryn BoyleBoyle.kathryn@epa.gov703.305.6304