Milestones for ImplementingInsect RepellentRule (Draft)Months after promulgation of rule12345678910111213141516171819202122Task/Event1 d60 d150 d240 d330 d1 yr545 dEPA holds workshop to provideinformation to producers ofcurrently exempted insectrepellents.1.Milestone #1: Producersdecide whether to commit topursue registration; submit“official letter” committing toapply for registration.2. EPA continues discussionswith producers and responds toletters.3. OPP notifies OECA aboutproducers who do not commit toregistration, and those that intendto seek registration.4.Milestone #2: Producers whocommit to registration submitregistration applications.5. OPP notifies OECA aboutproducers who do not submitapplications.6. EPA reviews and acceptsapplications to market within theexemption while seekingregistration.7. OPP notifies OECA aboutproducers whose applications areunacceptable.8.Milestone #3: Producers beginusing new labels on productsreleased for shipment.9. EPA initiates enforcementaction against producers who donot use new labels.10. Producers who commit toseek registration begin to identifylaboratories to develop efficacydata.11.Milestones #4, 5, 6, 7:at 1year, 2 years, 3 years and 4 years:Notify EPA of progress towardregistration (letter).12.Milestone #8: Finalapplication process.13. OPP notifies OECA aboutproducers who do not completethe registration process.14. Exemption expires anddisappears [5 years].OPP = Office of Pesticide ProgramsOECA = Office of Enforcement and Compliance AssuranceMilestones 5 - 8 are off scale.This timeline begins with the date of promulgation of the final rule (becomes effective 60 daysafter publication). Our estimates indicate between 34 to 72 products could seek transition toregistration.At the workshop, EPA discusses the Small Business Guidance (required by SBREFA). Thediscussions will focus on three main areas in that guidance:•Decision to commit to registering a currently exempted insect repellent product•Process for seeking aregistration from EPA•Laboratory search and protocol reviewApplicant = redEPA = greenEnforcement = yellowSearch for and contract witha testing facility = blueProducers deciding to market an inset repellent within the exemption must meet all eight milestones to remain exempted. Missing a milestone means that the product is no longer exempt and EPAcan take enforcement action.1.Milestone #1:Producers submit of a letter ofintent to pursue registration.Failure to meet this milestone would cause the exemption to expire immediately with respect to the particularproduct, and sale or distribution of the product would be prohibited, unless the productwere otherwise exempt. This also means that a new minimum risk personal insect repellent cannotenter the market as an exempted product after Milestone 1 has passed. After that time, the producer would seek a Section 3 registration by submitting the efficacy study with theapplication.2.EPA responds to the letter, by either email or a phone call. EPAbelieves that a meeting or teleconference would be beneficial, but also intends to provideinformation via email and theweb. The Small Entity Compliance Guidance will contain an example ofthe generic label that wouldbe expected, as well as additional information on the process. Producers shouldgather-up all their information fortheir discussions with EPA.3.Enforcement action can be initiated.4.Milestone #2:Producers who commit to registration submit registration application, which include an application form, CSF, and a “generic label.” If available, efficacy informationshould also be submitted. Note: There may be a few producers withsufficient information that could move directly to a registration process.5.Enforcement action can be initiated.6.EPA reviews the application package (CSF anddraft label with generic statements). EPA would review the CSF, and as needed, request modifications fromthe producer. EPA wouldreview the draft generic label, and, as appropriate, would modify the generic label statements to be product-specific. Producers with acceptable applications would receive anacknowledgement that their label, as modified, is acceptable. EPA assign a tracking number. (The tracking number would have the following format: Company number – 25000X, whereX is the individual product number. So, for company “999999”, the tracking number for their first product would be “999999-250001.”)7.Enforcement action can be initiated.8.Milestone #3:Producers have 6 months to transition to the new label. After 6 months, all product released for shipment must have the label accepted by EPA. Producers shouldcoordinate with selling establishments toassure that selling establishments do not have large stocks of older-labeled product.9.Enforcement action can be initiated.10.As soon as a producer decides to pursue registration they can begin the process of securing a contract with a testing laboratory. EPA will use a first-in system for HSRB review ofapplications.11.Letter describing progress toward registrationon a yearly basis. This is not intendedto be a lengthy letter, and need only contain a few pertinent that demonstrate progress, such as datecontract with laboratory was signed, date testing occurred, dates of Human Studies Review Board meetings on the product’s testing, etc.12.Producer submits a new label witha protection time [date + 4.5 year]. Agencyreviews and converts the tracking number to a registration number, if approved.13.Enforcement action can be initiated.14.Once the exemption has expired, EPA can remove the text and milestones for the transition from CFR.