Overall Process for EDSP OrdersRespondent Provides Initial Response1. Read Order2. Determine Response to the Order3. Submit Initial Response within 90 days.EPA Issues EDSP Order(s)1. Identify Chemical for EDSP2. Identify Order Recipient(s)(Registrant of pesticide active ingredient& Manufacturer or Importer of inert(other) ingredient.)3. Complete & Sign Order(s)4. EPA Issues Order(s)5. Publish list of RecipientsStartAgencyEndRespondentEPA Processes Initial Response1. Documents receipt of response2. Processes response as appropriateRespondent Implements Their ResponseUses applicable procedures to implement the actionindicated in their Initial response. See followingdiagrams for quick overview of the response options.Consults with EPA as needed.RespondentSubmits DataEPA Processes Data Submission1. Documents receipt of Data2. Processes data as appropriate3. Makes decision for Tier 2 testing4. Communicates decision, etc.EPA MonitorsResponses1. Takes action onnon-responders2. Completesfollow-up oncommitments, asappropriate.(04/03/2009) Page 1 of 11ConsultationsUsing existingprocedures, EPAand OrderRecipients(Respondents)may consult onvarious aspects ofthe order andresponse activitiesthroughout thisprocess.1.2.3.4.6. (A)7. (A)8.Respondent/Consortia SubmitsOther Informationper Response.6. (B)7. (B)Respondent Submits Progress Reportwithin 12 months of Order Issuance.5.Attachment EIf Respondent agrees to generate new data . . .

Agency RespondentGenerateDataSubmit ProgressReport w/in 12Months of OrderIssuanceSubmit FinalReport& Data to EPA w/in24 months of OrderIssuanceOPP1. Receive and process reports & final datasubmission according to existing procedures2. Complete documentation on receipt of the orderOPP1. Receive 90-day response.2. Document receipt of response.Determine &Submit InitialResponse w/in90 days of OrderIssuanceRequest an extension ? Consult w/EPA (e.g., onmodified methodologies)? Cite or submit otherscientifically relevant information (OSRI)?(04/03/2009) Page 2 of 11OSCP/OPP1. Coordinate Agency review of data received2. Recommend decision for Tier 2 testingOPPTS/AA1. Make decision for Tier 2 testing2. Communicate decisionIf Respondent chooses to cite or submit existing data . . .

Agency Respondent90 DayResponsePeriod BeginsRespond toAgency follow-up, if anyOPP1. Receive 90-day response2. Document receipt of responseOPP1. Receive submitted data or citations2. Process submission per existing procedures- Use format for data submissions in PR-Notice 86-53. Complete documentation on the orderDetermine &Submit InitialResponse w/in90 days of OrderIssuanceOSCP/OPP1. Coordinate Agency review of data2. If data are not responsive to order notify recipient- Consult as needed3. If data meet order requirements, recommend decision for Tier 2testingSubmit with 90-day response:A: Existing dataB: Citation to published dataOPPTS/AA1. Make decision for Tier 2 testing2. Communicate decision(04/03/2009) Page 3 of 11Cite or submit OSRI?If Respondent enters a joint agreement to provide the data . . .Develop Joint DataAgreementFollow same procedures forgenerating new data, i.e.,

Agency RespondentDetermine &Submit InitialResponse w/in90 days of OrderIssuanceOPP1. Receive response from individualcompanies within 90 days.2. Receive response from consortia(within 90 days, but no laterthan 150 days)3. Document consortia formation &receipt of responseGenerateDataSubmit FinalReport& Data to EPASubmitProgressReportsOPP1. Receive and process Reports & Final data submissionaccording to existing procedures2. Verify Agreement & Data Development3. Complete documentation on the orderOSCP/OPP1. Coordinate Agency review of data received2. Recommend decision for Tier 2 testingRequest an extension ? Cite or submit OSRI?Consult w/EPA (e.g., on modified methodologies) ?OPPTS/AA1. Make decision for Tier 2 testing2. Communicate decision(04/03/2009) Page 4 of 11Note: The Consortia may also citeexisting data for one or more ofthe assays.If Respondent claims they are not subject to the order . . .Follow-up toAgencyaction, asneeded

Agency RespondentDetermine &Submit InitialResponse w/in90 days ofIssuanceOSCP/OPP1. Coordinate Agency Review to verify claim2. Recommend decisionOPP1. Receive 90-day response2. Document receipt of responseWith 90 day response:Explain basis for claim ofnot being subjectOPPTS/AA1. Make decision on claim2. Communicate decision(04/03/2009) Page 5 of 11If order Involves Registered Pesticide AND Respondentchooses to request a voluntary cancellation . . .Complete any followup action toimplement requestOPP1. Receive request for Voluntary Cancellation (RVC)2. RVC is processed per existing procedures for VoluntaryCancellations- See procedures at 40 CFR 152.99- Includes public notice & comment3. The pesticide’s registration is cancelled, per request4. Close-out the Order

Agency RespondentDetermine &Submit InitialResponse w/in90 days of OrderIssuanceOPP1. Receive 90-day response2. Document receipt of responseSubmit w/in 90-daysof Order Issuance:Request for voluntaryCancellation usingexisting procedures.Note:This applies to registeredpesticides (active ingredients).Inert ingredients are handleddifferently.(04/03/2009) Page 6 of 11If order Involves Registered Pesticide AND Respondentchooses to reformulate the product(s) . . .Complete any followup action toimplement requestOPP1. Receive request to reformulate2. Request is processed per existing procedures- Includes public notice & comment3. The pesticide’s registration is amended, per request4. Close-out the Order

Agency RespondentDetermine &Submit InitialResponse w/in90 days of OrderissuanceOPP1. Receive 90-day response2. Document receipt of responseSubmit w/in 90-daysof Order Issuance:Request to reformulateusing existing procedures.Note:This applies to registeredpesticide products. Inertingredients are handleddifferently.(04/03/2009) Page 7 of 11If order Involves Registered Pesticide AND Respondentchooses to claim a formulators’ exemption . . .OPP1. Receive claim for formulator’s exemption2. Claim is processed per existing procedures3. Confirm claim of eligibility for this exemption4. Close-out the Order

Agency RespondentDetermine &Submit InitialResponse w/in90 days of OrderissuanceOPP1. Receive 90-day response2. Document receipt of responseComplete anyfollow-up actionto implementrequestSubmit with 90-day response:Request for formulator’sexemptionNote:Recipients of orders willonly use this option if EPAmade a mistake in identifyingthem, based on the approachoutlined in the EDSP Policy &Procedures Document.(04/03/2009) Page 8 of 11If order involves a pesticide inert ingredient AND the Respondent has or is in theprocess of discontinuing the manufacture or import of the chemical. . .Complete anyfollow-up actionto implementrequestOPP1. Verify assertion2. Review the confidential statements of formula (CSFs) on file toidentify use of this inert from this source.3. If used, notify Registrant that they must amend CSF.4. Process requests to amend CSF5. Close-out the Order

Agency RespondentDetermine &Submit InitialResponse w/in90 days ofOrder IssuanceOPP1. Receive 90-day response2. Document receipt of responseSubmit with 90-day response:- Documentation to demonstrate:a) they have already discontinued themanufacture or import ORb) are in the process of discontinuing themanufacture or importNote:This applies to inertingredients only. Activeingredients are handleddifferently.(04/03/2009) Page 9 of 11If order involves a pesticide inert ingredient AND the Respondent choosesto discontinue sales of the chemical in the pesticide market . . .Complete anyfollow-up actionto implementrequestOPP1. Receive commitment & copy of contract provision2. Add respondent to “approved inert supplier” list.3. Review the confidential statements of formula (CSFs) on file toidentify use of this inert from this source.4. If used, notify Registrant that they must amend CSF.5. Process requests to amend CSF6. Close-out the Order

Agency RespondentDetermine &Submit InitialResponse w/in90 days ofOrder IssuanceOPP1. Receive 90-day response2. Document receipt of responseSubmit with 90-day response:- Commitment to discontinue sales in thepesticide market- Copy of contract provision that prohibitssales in the pesticide market.Note:This applies to inertingredients only. Activeingredients are handleddifferently.(04/03/2009) Page 10 of 11If Respondent chooses not to respond . . .OPP1. Take appropriate action, e.g., Issue Notice of Intent to Suspend2. Close-out the Order.

Agency Respondent90 DayResponsePeriod PassesNo responseOPP1. Document non-response from Order recipient2. Coordinate with EPA legal team3. Recommend applicable action based on existing procedures for addressing non-responders to DCIs, e.g., suspend registration?OPPTS/AA1. Make decision on action to take2. Communicate decision(04/03/2009) Page 11 of 11