Page 1 of 1INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.Use additional sheet(s) if necessary.1. Company Name and Address4. EPA ProductRegistrationOMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460DATA CALL-IN RESPONSE3. Date and Type of DCI and NumberPRODUCT SPECIFIC01-Sep-2015ID # PDCI-043901-305032. Case # and Name2315 GlutaraldehydeChemical # and Name043901Glutaraldehyde5. I wish tocancel thisproduct registration voluntarily6. Generic Data7. Product Specific Data7a. My product is an MUP andI agree to satisfy the MUPrequirements on the attachedform entitled "RequirementsStatus and Registrant'sResponse."7b. My product is an EUP andI agree to satisfy the EUPrequirements on the attachedform entitled "RequirementsStatus and Registrant'sResponse."6a. I am claiming a GenericData Exemption because Iobtain the active ingredientfrom the source EPA registration number listed below.6b. I agree to satisfy GenericData requirements as indicatedon the attached form entitled"Requirements Status andRegistrant's Response."N.A.N.A.10. Name of Company11. Phone Number9. Date8. Certification I certify that the statements made on thisform and all attachments are true, accurate, and complete. I acknowledge that anyknowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.Signature and Title of Company'sAuthorized Representative__________________________________INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.Use additional sheet(s) if necessary.4. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 1 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC01-Sep-2015PDCI-043901-305032. Case # and Name2315 GlutaraldehydeEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321Product Chemistry Data Requirements (Antimicrobial)(1)830.15508EP; MP; TGAIProduct Identity and compositionV, R, U, Y, T, X, ZN(2)830.16008EP; MP; TGAIDescription of materials used to produce the productV, R, U, Y, T, X, ZN(3)830.16208EP; TGAIDescription of production processV, R, U, Y, T, X, ZN(4)830.16508EP; MP; TGAIDescription of formulation processV, R, U, Y, T, X, ZN(5)830.16708EP; MP; TGAIDiscussion of formation of impuritiesV, R, U, Y, T, X, ZN(6 ,7)830.17008EP; MP; TGAIPreliminary analysisV, R, U, Y, T, X, ZN830.17508EP; MP; TGAICertified limitsV, R, U, Y, T, X, ZN830.18008EP; MP; TGAIEnforcement analytical methodV, R, U, Y, T, X, ZN(8 ,9)830.63028MP; TGAIColorV, R, U, Y, T, X, ZN(10 ,11)830.63038EP; MP; TGAIPhysical stateV, R, U, Y, T, X, ZN(12 ,13)830.63048MP; TGAIOdorV, R, U, Y, T, X, ZN12. Name of Company13. Phone NumberSignature and Title of Company'sAuthorized Representative__________________________________10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. Iacknowledge that anyknowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law11. DateINSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.Use additional sheet(s) if necessary.4. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 2 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC01-Sep-2015PDCI-043901-305032. Case # and Name2315 GlutaraldehydeEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(14 ,15)830.63138TGAIStability to normal and elevated temperatures,metals, and metal ionsV, R, U, Y, T, X, ZN(16 ,17)830.63148EP; MP; TGAIOxidizing or reducing actionV, R, U, Y, T, X, ZN(18 ,19)830.63158EP; MPFlammabilityV, R, U, Y, T, X, ZN(20 ,21)830.63168EP; MPExplodabilityV, R, U, Y, T, X, ZN(22 ,23 ,24,25)830.631716EP; MPStorage stabilityV, R, U, Y, T, X, ZN(26 ,27)830.63198EP; MPMiscibilityV, R, U, Y, T, X, ZN(28 ,29 ,30,31)830.632016EP; MPCorrosion characteristicsV, R, U, Y, T, X, ZN(32 ,33 ,34)830.63218EPDielectric breakdown voltageV, R, U, Y, T, X, ZN(35 ,36 ,37)830.70008EP; MP; TGAIpHV, R, U, Y, T, X, ZN(38 ,39)830.70508TGAIUV/Visible absorptionV, R, U, Y, T, X, ZN(40 ,41)830.71008EP; MPViscosityV, R, U, Y, T, X, ZN(42 ,43)830.72008TGAIMelting point/melting rangeV, R, U, Y, T, X, ZNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateINSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.Use additional sheet(s) if necessary.4. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 3 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC01-Sep-2015PDCI-043901-305032. Case # and Name2315 GlutaraldehydeEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(44 ,45)830.72208TGAIBoiling point/boiling rangeV, R, U, Y, T, X, ZN(46 ,47 ,48)830.73008EP; MP; TGAIDensity/relative densityV, R, U, Y, T, X, ZN(49 ,50)830.73708TGAIDissociation constants in waterV, R, U, Y, T, X, ZN(51 ,52)830.75508TGAIPartition coefficient (n-octanol/water), shake flaskmethodV, R, U, Y, T, X, ZN(53 ,54)830.75608TGAIPartition coefficient (n-octanol/water), generatorcolumn methodV, R, U, Y, T, X, ZN(55 ,56)830.75708TGAIPartition coefficient (n-octanol/water), estimation byliquid chromatographyV, R, U, Y, T, X, ZN(57 ,58)830.78408TGAIWater solubility: Column elution method, shake flaskmethodV, R, U, Y, T, X, ZN(59 ,60)830.78608TGAIWater solubility, generator column methodV, R, U, Y, T, X, ZN(61 ,62)830.79508TGAIVapor pressureV, R, U, Y, T, X, ZNToxicology Data Requirements (Antimicrobial)870.11008EP; MP; TGAIAcute Oral ToxicityV, R, U, Y, T, X, ZNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateINSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.Use additional sheet(s) if necessary.4. GuidelineRequirementNumber5. Study Title1. Company Name and AddressPage 4 of 4OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #PRODUCT SPECIFIC01-Sep-2015PDCI-043901-305032. Case # and Name2315 GlutaraldehydeEPA Reg. No.8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321(63)870.12008EP; MP; TGAIAcute dermal toxicityV, R, U, Y, T, X, ZN870.13008EP; MP; TGAIAcute inhalation toxicityV, R, U, Y, T, X, ZN(65)870.25008EP; MP; TGAIAcute dermal irritationV, R, U, Y, T, X, ZN(66)870.26008EP; MP; TGAISkin sensitizationV, R, U, Y, T, X, ZN(64)870.24008EP; MP; TGAIAcute eye irritationV, R, U, Y, T, X, ZN(68)810.21008EPSterilantsV, R, U, Y, T, X, ZN(69)810.22008EPDisinfectants for Use on Hard SurfacesV, R, U, Y, T, X, ZN(70)810.23008EPSanitizers for Use on Hard SurfacesV, R, U, Y, T, X, ZN(71)810.24008EPDisinfectants and Sanitizers for Use on Fabrics andTextilesV, R, U, Y, T, X, ZN(67)810.25008EPAir SanitizersV, R, U, Y, T, X, ZN(72)810.26008EPDisinfectants for Use in WaterV, R, U, Y, T, X, ZNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateThe following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 1 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active IngredientUse Categories Key:R -T -U -Agricultural premises and equipmCommercial, institutional and indResidential and public access prV -X -Y -Medical premises and equipmenMaterials preservativesIndustrial processes and watersZ - Industrial processes and waters1The Confidential Statement of Formula (CSF) form may be referenced.2In addition to guideline information, providing the MSDS for each component in formulation is recommended.3Waiver may be requested if the product is a non-integrated system.4Providing a flow chart for the formulation process is recommended.5Waiver may be requested if the product is a non-integrated system.6Waiver may be requested if the product is a non-integrated system.7For an integrated system, a five batch analysis is preferred. The analysis must be based on the product to assay the active ingredient (AI). If the product is solely AI, then the certificate ofanalysis (COA) may be used in place of the five batch analysis. A COA for each supplier must be provided8The method that was used must be provided.9Provide the temperature when the study was conducted.10The method that was used must be provided.11Provide the temperature when the study was conducted.12The method that was used must be provided.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 2 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active IngredientUse Categories Key:R -T -U -Agricultural premises and equipmCommercial, institutional and indResidential and public access prV -X -Y -Medical premises and equipmenMaterials preservativesIndustrial processes and watersZ - Industrial processes and waters13Provide the temperature when the study was conducted.14The method that was used must be provided.15Provide the temperature when the study was conducted.16The method that was used must be provided.17Provide the temperature when the study was conducted.18The method that was used must be provided.19Provide the temperature when the study was conducted.20The method that was used must be provided.21Provide the temperature when the study was conducted.22The method that was used must be provided.23Accelerated (temperature between 40 to 55 oC) storage stability can be reported to be equivalent to this guideline as long as: the AI meets the EPA Standard Certified Limits; data must bereported at the initial, in between, and at the end of the study for 14 or 30 days. If the study does not pass, then the applicant must conduct the one-year study at room temperature.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 3 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active IngredientUse Categories Key:R -T -U -Agricultural premises and equipmCommercial, institutional and indResidential and public access prV -X -Y -Medical premises and equipmenMaterials preservativesIndustrial processes and watersZ - Industrial processes and waters24The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. You are then required to submit a progress report to the Agency within 3months following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In Notice. If you intend to submit an existingstudy or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-day study at elevated temperatures maybe conducted and, if found acceptable, may be used to replace the one-year study.25Provide the temperature when the study was conducted.26Provide the temperature when the study was conducted.27The method that was used must be provided.28The method that was used must be provided.29An accelerated equivalent study may be conducted in conjunction with 830.6317.30The 16-month deadline for submission of this study applies if you are conducting a new study to satisfy this requirement. You are then required to submit a progress report to the Agency within 3months following the 90-Day response deadline for this PDCI. Further information appears on page 7 of the Generic and Product Specific Data Call-In Notice. If you intend to submit an existingstudy or cite previously submitted data, they must be submitted with your 90-Day Response. Alternatively, a combined, abbreviated, non-guideline, 14-day study at elevated temperatures maybe conducted and, if found acceptable, may be used to replace the one-year study.31Provide the temperature when the study was conducted.32The method that was used must be provided.33Provide the temperature when the study was conducted.34Waiver may be requested if the product is not intended to be use near electric outlet.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 4 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active Ingredient35The method that was used must be provided.36The value must be reflected on the CSF form.37Provide the temperature when the study was conducted.38The method that was used must be provided.39Provide the temperature when the study was conducted.40Provide the temperature when the study was conducted.41The method that was used must be provided.42The method that was used must be provided.43Provide the temperature when the study was conducted.44The method that was used must be provided.45Provide the temperature when the study was conducted.46The value must be reflected on the CSF form.47Provide the temperature when the study was conducted.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 5 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active Ingredient48The method that was used must be provided.49The method that was used must be provided.50Provide the temperature when the study was conducted.51The method that was used must be provided.52Provide the temperature when the study was conducted.53The method that was used must be provided.54Provide the temperature when the study was conducted.55Provide the temperature when the study was conducted.56The method that was used must be provided.57The method that was used must be provided.5856 Provide the temperature when the study was conducted.59The method that was used must be provided.60Provide the temperature when the study was conducted.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 6 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active Ingredient61The method that was used must be provided.62Provide the temperature when the study was conducted.63Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of potential dermal toxicity.64Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of potential eye irritation.65Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as Toxicity Category 1 on the basis of potential dermal irritation.66Waiver may be requested if test material is corrosive to skin or has pH < 2 or >11.5; such product will be classified as a dermal sensitizer.67Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.68Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.69Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.70Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.71Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.The following footnotes are referenced in column two (5. Study Title) of the Requirements Status and Registrant's Response form. These footnotes apply in addition to anytest notes included in 40 CFR Part 158 with respect to the particular data requirementCase # and Name:2315 GlutaraldehydeDCI Number:PDCI-043901-30503Page 7 of 7Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSEP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; EP; MP = End UseProduct, Manufacturing Use Product; EP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]; EP; TGAI = EndUse Product; Technical Grade Active Ingredient72Refer to the Product Performance Test Guideline 810.2000 (general considerations for testing antimicrobial products) and the reregistration efficacy guidance document athttp://www.epa.gov/oppad001/reregistration-efficacy-standards.pdf for additional information.