1Insect Repellents:Reconsideration of ExemptionRevising the Minimum Risk Pesticide Exemption toRemove Skin-Applied Insect RepellentsSmall Business Advocacy Review PanelNovember 20092Presentation Purposeand Agenda•Purpose:–To provide an overview of potential changes to the exemption forminimum risk pesticides that would impact skin-applied insect repellentproducts–To explain your role as a Small Entity Representative in providingfeedback on this issue•Agenda:–SER (Small Entity Representative) Guidance–EPA’s Mandate to Regulate Pesticides–Introduction to Minimum Risk Exemption under 40 CFR 152.25(f)–Why Re-Evaluate the Exemption for Minimum Risk Skin-Applied InsectRepellents?–Project Goal–Small Businesses Impacted–Approaches Considered–Cost Estimates for Selected Options–Regulatory Flexibility Options for Small Entities–Attachments3What is ....?•The term "insect repellent" is used throughout thispresentation in reference to products thatclaimtoinhibit, prevent, or deter the landing and biting of avariety of insects (including ticks).•The term “claim” is used to refer to statements that areon the label of a pesticide product.•The term “skin applied insect repellent” is used to refer toinsect repellents that are applied to the skin, worn on thebody (e.g. wrist-bands), or attached to clothing (e.g.,patches or jewelry).4What is a SER?•A SER (Small Entity Representative) is a representativeof a small entity who may be subject to the requirementsof a proposed rule that EPA has under development.•SERs’ participation in the rulemaking process helps toensure that EPA hears the concerns and suggestions ofsmall entities.•The Panel (EPA, SBA, & OMB) then uses your input toprepare a report that includes the Panel’srecommendations on minimizing the burden on smallentities. The report is part of the rulemaking record and isconsidered by Agency decisionmakers.5SER Guidance•Your role is to help identify and exploreoptions to minimize the burden to smallentities while still assuring the protectiveness against mosquitoes and ticks of skinapplied insect repellents. For the options presented, let us know if there are differentways to accomplish these goals that would cost you less.•EPA identified marketers of skin-applied insect repellents by using state-registrationlists, information purchased from a national marketing company, and internetsearches. This included manufacturers whosell their product toconsumers, thosewho re-pack/relabel productsproduced by other firms.•We believe that you, as a group, constitute reasonable representation of theproducers potentially affected.•Please attend the conference call, as possible, to facilitate information sharing.•Please provide written comments on the topics discussed at the conference callwithin two weeks.•See also two attached EPA factsheets on SERs and the SBREFA Process(attachments 1 and 2)6FIFRA 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 product7FIFRA 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), in attachment 38Minimum 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•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)9Why Re-Evaluate theMinimum Risk Exemption?•This re-examination is prompted by:–Changes in public health hazards•Emergence of a new mosquito-borne disease•Increased incidence of tick-borne disease–Recognition that exempt status may be inappropriatefor insect repellents because they have a publichealth role–Information from States regarding compliance withthe regulation.–Public confusion regarding insect repellents–Stakeholder requests10Public Health Hazards•According to CDC, insect repellents have arole in disease prevention–A single bite can transmit enough infectious agentsto cause disease.•Since 1996, new public health concerns haveemerged, for example:–Introduction in 1999 of West Nile virus, transmittedby mosquitoes.–Increased prevalence of Lyme disease, transmittedby ticks.–See attachments 4 & 5 for specific CDC data onthese disease trends11Lyme Disease12West Nile Virus13Recommendationsfrom CDC•“Repellents are an important toolto assist people in protectingthemselves from mosquito-borne diseases.”•A 2003 survey conducted by CDC anda Colorado County HealthDepartment assessed the following adultpersonal protective practices: useof DEET repellents, long sleeves and pants, drain standing water, limit duskto dawn exposure. The authors found that “Personal protective practicesmay directly influence rates of WNV infection” (Gujral et al,EmergingInfectious Diseases, 13 3:2007)•The full article is included as attachment 6•“CDC recommends using products that have been shown to work inscientific trials and that containactive ingredients which have beenregisteredwith” EPA. Use products that areregisteredby EPAbecause EPA, before licensing each product, has reviewed:•Safety and efficacy data supporting the product•Product label to assure that the information on the label matches thesupporting data•These recommendations are detailed in attachments 7a and b fromthe CDC website14Concerns Driving EPA’sRe-Evaluation•Given the increased public health concerns, ensuring efficacy ofexempted skin applied insect repellent products has increased inAgency priority•Repellents that do not bear anEPA registration number have notbeen evaluated by EPA–EPA cannot advise consumers aboutthe effectiveness of theseproducts.–EPA cannot assure that exempted products provide reliable protectionfrom mosquitoes and ticks•Available information indicates thatmany exempt products are lesseffective than claimed on the label.–See attachment 8 for the 2002 article by Fradin and Day published intheNew England Journal Of Medicine•Soybean–based product comparable to a low concentration DEET product•Citronella-based repellents protected for 20 min or less–See also a June 2006 summary of tests byConsumer Reportswithsimilar findings•Four of the 18 products tested werebotanicals: they had the lowestprotection scores15States’ Concerns•Exemption created significant enforcement concerns for States and EPARegions by creating a category oflegalunregistered products–Increased regulatory burden on the States; (misbranding, false/misleadingclaims)–Difficult to determine whethera product meets the exemption.–Without a registration number, difficult to track producers and follow-up oncomplaints–Lengthy case-specific process – need tofind the product, evaluate it, and bringan enforcement case. Each case takes years.•37 states require registration of allpesticides – including those federallyexempt–Additional burden for States to make registration decisions forproducts with noFederal registration–Multiple state registration processesand requirements create inconsistenciesand additional burdens for producers•Enforcement is ineffective:–Easy for unscrupulous producers to dodge consequences.–Victories are transitory as manufacturers can easily re-enter the market with aslightly re-labeled product.16Potential forPublic Confusion•Mixed message:–CDC says use a registered insect repellent product to ensureprotection against ticks and mosquitoes.–EPA allows exempt products•Registered and exempt products marketed side-by-side–Do consumers understand the difference?–Consumers may not know thatexempt products may not havebeen tested for efficacy•Consumers assume insect repellents that are on themarket are safe and work as claimed. They make theirpersonal risk protection decisions based upon thatassumption.17StakeholderRequests•June 2000, the American Associationof Pesticide Control Officials(AAPCO, a group of state officials) requested EPA reconsider lettingproducts be exempt•CDC consistently has opposed the exemption on several occasions.Recommends registered products to ensure efficacy.•November 2004, Consumer Specialty Products Association (CSPA)requested better enforcement of exempt products (false claims) orwithdraw 25(b) entirely.•March 2006, CSPA submitted apetition to modify the rule.•CSPA’s petition contends that EPA isputting the American Public atundue risk by not requiring registration including proof of efficacy forproducts that claim to control public health pests such asmosquitoes and ticks.18CSPA Petition•Consumer Specialty Products Associationrequested that EPA:–Initiate rulemaking to exclude from 152.25(f)pesticides that claim to control “pests of significantpublic health importance”–Require stability and efficacy data for any productsthat are to be used for public health pests–See attachment 9 for the full text of the petition, or gotowww.regulations.govfor the petition and allcomments (docket EPA-HQ-OPP-2006-0687)19EPA’s Response•Agreed that products intended for thecontrol of public health pests must beeffective•Believe that many of the concernsexpressed in the petition have merit andthat action is needed•See attachment 10 for the full text ofEPA’s response to the petition20EPA’s Goal forMinimum RiskInsect RepellentsAssure that minimum risk personal insectrepellent products perform effectively sothat users receive protection from insectsor ticks that may transmit seriousdiseases.21Potential Phases ofEPA’s ActionAt this time, EPA is focusing on insect repellentsclaiming to repel mosquitoes and ticks and whichare applied to the skin, worn on the body (e.g.wrist-bands), or attached to clothing (e.g., patchesor jewelry).Other kinds of insect repellents such as candlesare area repellents. While EPA is not consideringaction on these products at this time, the Agencymay do so in the future.22Small BusinessesImpacted•Producers of minimum risk, skin-applied insect repellentproducts exempted under 40 CFR 152.25(f) would bepotentially impacted by the upcoming regulation•EPA identified 78 such products that are marketed orwhich represent themselves as exempt from Federalregistration, and that, according to the availableinformation, meet the exemption criteria for ingredients•These 78 products are produced by 36 companies.•Thirty of these companies are classified as smallcompanies and are located in the US23Small BusinessesImpacted (continued)•The Small Business Administration defines“small business” variably, based on each firm’scategory in the North American IndustryClassification System (NAICS)–Variety of NAICS codes since impacted businessescould derive income from other products and servicesin addition to insect repellents–See attachment 11 for a list of industry sectors,definitions, and number of small entities potentiallyaffected by these changes24Criteria forEvaluating Options•Ability to ensure that skin-applied insectrepellents work as claimed on the label•Continued availability of effective minimumrisk personal insect repellents•Minimize costs to industry, includingimpacts on small businesses•Ability for States to effectively enforce•Sensible, workable approach25Options•EPA has considered a range of options,including:–Status quo–Increased enforcement–Label disclaimer–Partial exemption–Regulatory actions (section 3 registration)26Preliminary Screeningof 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)regulations; remove illegalproducts from the market; reduce instances of misleading or false claims–Would not eliminate ineffective exempt products–Progress is transitorybecause a producer canchange the firm orproduct name, orresume businessin another state–State resources are limited•Label disclaimer -Label statement that EPA hasnot reviewed the product–Literature review indicatesthat a label disclaimer willnot cause anyone to changepurchasing behavior, and may not even be noticed–See attachment 12•Partial Exemption–Did not achieve the objectivesof assuring effective products and resolving enforcementissues.Preliminary screening of options indicates that regulatory action under FIFRAsection 3 may best meet the criteria27Regulatory Options•EPA is considering multiple regulatoryapproaches, or licensing options, under FIFRAsection 31.Removeall skin applied insect repellents from theexemption and require licensing using existing datarequirements, processes and procedures2.Require a streamlined dataset, and use simplifiedprocesses and procedures to support claims onlabel•efficacy data•product chemistry data•acute toxicity data3.Require only efficacy dataand very streamlinedprocesses and procedures28EPA’s CostEstimates for Options•Under theremoveoption:–All skin applied insect repellents will require licensing under FIFRAsection 3–Same as that for a biochemical pesticide registration•Under therequire streamlined datasetoption–Estimated costs of conducting efficacy studies•Efficacy test for mosquitoes (perspecies) -- $96K (includes HSRB)•Efficacy test for ticks (perspecies) -- $57K (includes HSRB)–Estimated costs of conducting product chemistry studies -- $24K perproduct–Estimated costs of conducting acute toxicity studies – up to $46K perproduct•Under therequire only efficacy dataoption–Estimated costs of conducting efficacy studies•Efficacy test for mosquitoes (per species) -- $96K•Efficacy test for ticks(per species) -- $57K29EPA’s CostEstimates (continued)•Under licensing options, companies could lowertheir data costs by:–Submitting existing studies conducted on the productof interest or a very similar product–Submitting published data from open literatureconducted on the product of interest or a very similarproduct–Relying on another companies’ data, if the product isvery similar, though compensation of the othercompany for use of its data may be necessary–Sharing costs/cooperative commissioning new data, ifthe products are very similar30EPA’s CostEstimates (continued)•Under all licensing options: otherregistration costs to consider–PRIA fees for submissions to EPA ($4K)–EPA yearly maintenance fees ($3 – 4K)–Company’s costs to relabel ($2 – 4K)–State registration fees ($ 100s/yr/state)•EPA registration does not replace the need forstate registrations•States that currently do not register exemptproducts do register all federally regulatedproducts31Timeline•Small Business Advocacy Review Panel(SBAR Panel): through mid January 2010•Proposed Rule for public comment:planned Summer 201132Regulatory Flexibility Optionsfor Small Entities•We would like to discuss and solicit suggestions from theSmall Entity Representatives to identify the leastburdensome ways to construct the regulation that wouldalso meet our project goal.–Your perspective on costs–Your suggestions for alternatives–Other information we should consider on nonregulatory options–Your ideas on how to make the implementationeasiest for you (more workable)–More about who you are and your business: Forexample, do you manufacture or re-pack?33Attachments1.Fact Sheet: What Potential Small Entity Representatives (SERs) Should KnowAbout The Small BusinessAdvocacy Review Panel Process (also available athttp://www.epa.gov/sbrefa/documents/serftsht2009.pdf)2.Fact Sheet: What Small EntitiesShould Know About Regulatory Flexibility Act And The Small BusinessRegulatory Enforcement FairnessAct (SBREFA) (also available athttp://www.epa.gov/sbrefa/documents/sbrefaftsht2009.pdf)3.The Minimum Risk Exemption - 152.25(f) text (also available at e-cfrhttp://ecfr.gpoaccess.gov/))4.CDC Data on Lyme Disease(also available athttp://www.cdc.gov/ncidod/dvbid/Lyme/resources/Lyme08Cases.pdf)5.CDC Statistics on West Nile Virus6.Gujral, Zielinski-Gutierrez, LeBailly, Nasci. (2007). “Behavioral risks for West Nilevirus disease, northernColorado, 2003.”Emerging Infectious Diseases(http://www.cdc.gov/eid/content/13/3/pdfs/419.pdf)7.a. CDC Updated Information regarding Mosquito Repellents(also available online athttp://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 InsectRepellents Against Mosquito Bites.” N. Engl. J. Med.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 comments: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/25bpetition_letters/epa_response.pdf)11.List of industrial sectors, definitions, and numbers of small entities potentially affected12.Effectiveness ofLabel Disclaimers