1Minimum-Risk ProductsExempted under 40 CFR152.25(f) under the Authority ofFIFRA 25(b)Conference Call with StatePesticide RegulatorsFebruary 16, 20102Welcome•Please send me an email:Boyle.kathryn@epa.gov3Presentation Purposeand Agenda•Purpose:–This is an update to the information presentedat our previous call, last February•Explain current status of the potential insectrepellent rulemaking•Discuss potential changes to 152.25(f)–We want your feedback, especially on thepotential changes to the exemption•Are these potential changes workable?•Would you benefit if these potential changesbecame reality?4Background•We began in 2006 to re-evaluate if publichealth pesticide products should beexempted under 152.25(f)•Potentially 3 Rulemakings Related toExempted Products1.Remove skin-applied insect repellents from theexemption2.Make modifications to 152.25(f), in general3.Review active ingredient list5First Project•The workgroup is designing a targetedregulatory fix for skin-applied insect repellents:–We are exploring the option of registering theseproducts under FIFRA section 3•If registration is required, we are consideringwhat information would producers of currentlyexempted insect repellents need to submit toEPA in an application package:–CSF (Confidential Statement of Formula)–Label–Efficacy Study–Other data?6Workgroup’s CurrentActivities•Completed SBREFA (Small BusinessRegulatory Enforcement Fairness Act)Panel•Completing the Economic Analysis (EA)•Preparing for senior managementdecisions on the proposed rule7Second Project•In December 2008, at SFIREG, we asked: Whatchanges to 152.25(f) could help you to workmore efficiently?•Three things we learned were:–State inspectors need a common chemical name onthe product–States want the active ingredient list to have CASReg No.s, and a strict interpretation–States want one inert ingredient list with a cleardistinction between the food use and nonfood use8Potential Changes to152.25(f)1.Require the Use of a Common ChemicalName on the Label2.Redefine the List of Active Ingredients3.Codify the Existing List of InertIngredients9Potential Change 1•Why a Common Chemical Name?–Greater specificity–Assist State inspectors•Examples of Common Chemical Names•1,2,3-Propanetricarboxylic acid, 2-hydroxy- is citric acid•9-Octadecenoic acid (9Z)-, diester with 1,2,3-propanetriol is glyceryldioleate•In March 2009, OPP updated the inert ingredient list (on theweb) to include a common namehttp://www.epa.gov/opprd001/inerts/section25b_inerts.pdfPotential Action:•In 40 CFR 152.25(f)(3) codify that the common chemicalname, as determined by EPA, should be used in theingredient statement10What 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 E11Potential Change 2Redefine the List of Active Ingredients•This would clarify the list of active ingredients by being more specific–Different process than the active ingredient list review•Current listings like “mint oil” and “cedar oil” are vaguePotential Action:•Replace the current listing of chemical names in 40 CFR 152.25(f)(1)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 active ingredient listreview)12Possible Table for ActiveIngredients for 152.25(f)(1)CAS Reg. No.CommonChemicalName/LabelDisplay NameCA Index NameCaveats/Specifications68917-18-0Mint oilOils, mint, menthaarvensispiperascens8008-79-5Spearmint oilOils, menthaspicata8006-90-4Peppermint oilTerpenes &terpenoids,peppermint oil13Benefits of Redefining theList in 152.25(f)(1)•State inspectors could easily match the labelname with the name on the label displayname list•Potential for reduced follow-up frominspections, fewer questions and concerns•Linking the CAS Reg. No., the common nameand the CA Index Name maintains thespecificity needed for enforcement, and yetgives the public and the inspectorsunderstandable information14Potential Change 3Codify the Existing List of Inert IngredientsPotential Action:•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 (all chemicals in the list could be used in nonfoodexempted products)–Add a cross-reference to 40 CFR 180.950•Future changes to the codified list would beaccomplished via notice and comment -- rulemaking15Possible Tablefor 152.25(f)(2)CAS Reg. No.Common ChemicalName/LabelDisplay NameCA Index NameFood-Use?25637-84-7Glyceryl dioleate9-Octadecenoic acid(9Z)-, diester with1,2,3-propanetriolno298-14-6PotassiumbicarbonateCarbonic acid,monopotassium saltyes121-33-5VanillinBenzaldehyde, 4-hydroxy-3-methoxyyes16Benefits of Codifying theList of Inert Ingredients•Benefits:–Codified tables would be a clear source ofinformation for all users regarding inertingredients acceptable for use in exemptedproducts–Purchasers would have understandableinformation concerning the ingredients in theproducts purchased17Timeframe•EPA expects to publish a proposed rule forthese changes at the same time that theproposed rule for the targeted regulatoryfix for skin-applied insect repellents ispublished•Currently projected for Summer 201118What do you Think?•Discussion•For additional information on thesepotential changesKathryn BoyleBoyle.kathryn@epa.gov703.305.6304