Poly(oxy-1,2-ethanediyl(dimethylimino)-1,2-ethanediyl(ddichloride)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 2OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #GENERIC29-Sep-2011GDCI-069183-301932. Case # and Name3034 Busan 77 (*)069183Chemical # and Name8. TimeFrame(Months)9. RegistrantResponse7.TestSubstance6. UsePatternPROTOCOLProgressReports321Applicator Exposure Data Requirements (Antimicrobial)(6 ,7 ,8 ,28,35)875.110024Dermal exposure--outdoorV, Y, T, X, O, L, SN(9 ,10 ,11 ,29,36)875.120024Dermal exposure--IndoorV, Y, T, X, O, L, SN(12 ,13 ,14,30 ,37)875.130024Inhalation exposure--outdoorV, Y, T, X, O, L, SN(15 ,16 ,17,18 ,31 ,38)875.140024Inhalation exposure--indoorV, Y, T, X, O, L, SN(19 ,32 ,34)875.160012Application exposure monitoring data reportingV, Y, T, X, O, L, SNPostapplication Exposure Data Requirements (Antimicrobial)(3 ,4 ,5 ,20)875.230024Indoor surface residue dissipationV, Y, T, X, O, L, SNTerrestrial and Aquatic Nontarget Organisms DataRequirements (Antimicrobial)(1 ,2 ,21)850.173512TGAIWhole sediment: acute freshwater invertebratesV, Y, T, X, O, L, SN12. 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. DatePoly(oxy-1,2-ethanediyl(dimethylimino)-1,2-ethanediyl(ddichloride)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 2 of 2OMB Approval 2070-174United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #GENERIC29-Sep-2011GDCI-069183-301932. Case # and Name3034 Busan 77 (*)069183Chemical # and Name8. TimeFrame(Months)9. RegistrantResponse7.TestSubstance6. UsePatternPROTOCOLProgressReports321(23)850.130012Daphnid chronic toxicity testV, Y, T, X, O, L, SN(24)850.140012Fish early-life stage toxicity testV, Y, T, X, O, L, SN(25)850.422512Seedling emergence, Tier IIV, Y, T, X, O, L, SN(26)850.440012Aquatic plant toxicity test using Lemna spp. Tiers Iand IIV, Y, T, X, O, L, SN(27)850.540012Algal toxicity, Tiers 1 and IIV, Y, T, X, O, L, SN(33 ,39)SS-AFM-124Aquatic Field Monitoring, Once-Through CoolingWater SystemsV, Y, T, X, O, L, SN(22)850.174012Whole sediment: acute marine invertebratesV, Y, T, X, O, L, SNInitial to indicate certificationas to information on this page (fulltext of certification is on page one).DateCase # and Name:3034 Busan 77 (*)DCI Number:GDCI-069183-30193Page 1 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSTGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:L -O -S -Indoor food useResidential Indoor useFood handling/storage establishT -V -X -Commercial, institutional and indMedical premises and equipmenMaterials preservativesY - Industrial processes and waters1Data are required on a case-by-case basis depending on: (i) The results of lower-tier ecological effects studies in the activeingredient or end-use product demonstrate high toxicity to aquaticorganisms. (ii) Physicochemical properties indicate cumulative effects may occur (e.g., Kow is greater than or equal to 1,000). (iii) The active ingredient or principal transformation products arepersistent in water (e.g., hydrolysis half-life in water is greater than 4 days). (iv) For wood preservative uses, these data are required if any of the conditions in note (15)(i)-(iii) apply and treatedwood will be used in the aquatic environment (including estuarine/marine environments) or use of treated wood in aquatic environments is not prohibited by product labeling.2Sediment toxicity testing is required if a pesticide meets any of the following conditions: (i) Solubility is less than or equal to 0.1 mg/L. (ii) Koc is greater than 1,000 (or log10 Koc less than orequal to 4.0). (iii) Kd is greater than or equal to 50. (iv) The pesticide persists in sediments with a half-life greater than10 days. (v) Concentration in the interstitial water is equivalent toconcentrations known to be toxic in the water column. (vi) For wood preservative uses, these data are required if any of the conditions in note (16)(i)-(iii) apply and treated wood will be used inthe aquatic environment (including estuarine/marine environments) or when use of treated wood in aquatic environments is not prohibited by product labeling.3The Agency will require postapplication exposure data beyond the required product use and human activity information by the appropriate route(s) of exposure if at least one of the followingexposure criteria and one of the following toxicity criteria are met by the TGAI orany of the pesticide's metabolites:(i) Exposure criteria. (A) Dermal exposure to workers upon reentry, or tobystanders and residents, is likely to occur. (B) Inhalation exposure to workers upon reentry, or to bystanders and residents,is likely to occur. (C) The human activities associated with thepesticide use pattern (e.g. use in swimming pools and spas) can lead to potentially high exposures. (D) Surrogate exposure data that the Agency deems acceptable (e.g. PHED) to estimatethe magnitude of exposure for a particular postapplication work activity, with an adequate degree of confidence, are unavailable.(ii) Toxicity criteria. (A) The acute dermal LD50 of the TGAI(Guideline 870.1200) is less than or equal to 2000 mg/kg (i.e., Toxicity Category I or II as per 40 CFR 156.10). (B) The acuteinhalation LC50 of the TGAI (Guideline 870.1300) is less than orequal to 0.5 mg/liter (i.e., 4-hour exposure, Toxicity Category I or II) and the TGAI has a vapor pressure greater than 10-3 mmHg at 25 degrees C if used outdoors or any indoor applicationregardless of the vapor pressure. (C) The acute oral LD50 of the TGAI (Guideline 870.1100) is less than 50 mg/kg (i.e., Toxicity Category I). (D) The pesticide is found to be a neurotoxicant(Guideline 870.6200). (E) The pesticide is found to be a developmental toxicant (Guidelines 870.3700 and 870.6300). (F) Thepesticide is found to be a carcinogen (Guideline 870.4200). (G)The pesticide shows potential adverse effects in subchronic studies such as the 90-day oral (Guideline 870.3100), 21-day repeated dose dermal toxicity (Guideline 870.3200), 90-day dermaltoxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproduction a4Required if the use pattern and formulation types involve significant potential exposure to humans by evaporation of residues from surfaces or contact with residues on treated surfaces.5Protocols must be submitted to the Agency for approval before initiating a study.6The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at leastone of the following exposure criteria and at least one of thefollowing toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermalexposure is likely to occur during use. (B) Inhalation exposure is likelyto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceptable degree of confidence areunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity CategoryI (Guideline 870.1200) as per 40 CFR 156.10). (B) The acute inhalationLC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI hasa vapor pressure greater than 10-3 mm Hg at 25degrees C if usedoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesticide is found to be a developmentaltoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adverse effects in subchronic studies suchas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproductionand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to 870.5900) or an immunotoxicant(Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.Case # and Name:3034 Busan 77 (*)DCI Number:GDCI-069183-30193Page 2 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSTGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:L -O -S -Indoor food useResidential Indoor useFood handling/storage establishT -V -X -Commercial, institutional and indMedical premises and equipmenMaterials preservativesY - Industrial processes and waters7Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.8Protocols must be submitted to the Agency for approval before initiating a study.9The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at leastone of the following exposure criteria and at least one of thefollowing toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermalexposure is likely to occur during use. (B) Inhalation exposure is likelyto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceptable degree of confidence areunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity CategoryI (Guideline 870.1200) as per 40 CFR 156.10). (B) The acute inhalationLC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI hasa vapor pressure greater than 10-3 mm Hg at 25degrees C if usedoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesticide is found to be a developmentaltoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adverse effects in subchronic studies suchas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproductionand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to 870.5900) or an immunotoxicant(Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.10Protocols must be submitted to the Agency for approval before initiating a study.11Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.12The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at leastone of the following exposure criteria and at least one of thefollowing toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermalexposure is likely to occur during use. (B) Inhalation exposure is likelyto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceptable degree of confidence areunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity CategoryI (Guideline 870.1200) as per 40 CFR 156.10). (B) The acute inhalationLC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI hasa vapor pressure greater than 10-3 mm Hg at 25degrees C if usedoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesticide is found to be a developmentaltoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adverse effects in subchronic studies suchas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproductionand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to 870.5900) or an immunotoxicant(Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.13Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.14Protocols must be submitted to the Agency for approval before initiating a study.Case # and Name:3034 Busan 77 (*)DCI Number:GDCI-069183-30193Page 3 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSTGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:L -O -S -Indoor food useResidential Indoor useFood handling/storage establishT -V -X -Commercial, institutional and indMedical premises and equipmenMaterials preservativesY - Industrial processes and waters15The Agency will require application exposure data beyond the required product use information (Guideline 875.1700) if at leastone of the following exposure criteria and at least one of thefollowing toxicity criteria are met by the TEP, TGAI, or one of the pesticide's metabolites: (i) Exposure criteria. (A) Dermalexposure is likely to occur during use. (B) Inhalation exposure is likelyto occur during use. (C) Adequate surrogate exposure data (e.g. PHED) to estimate the magnitude of exposure for a particular work activity with an acceptable degree of confidence areunavailable. (ii) Toxicity criteria. (A) The acute dermal LD50 is less than or equal to 200 mg/kg (i.e., Toxicity CategoryI (Guideline 870.1200) as per 40 CFR 156.10). (B) The acute inhalationLC50 (Guideline 870.1300) is less than or equal to 0.05 mg/liter (i.e., 4-hour exposure, Toxicity Category I) and the TGAI hasa vapor pressure greater than 10-3 mm Hg at 25degrees C if usedoutdoors or any indoor application regardless of the vapor pressure. (C) The pesticide is found to be a neurotoxicant (Guideline 870.6200). (D) The pesticide is found to be a developmentaltoxicant (Guidelines 870.3700 and 870.6300). (E) The pesticide is found to be a carcinogen (Guideline 870.4200). (F) The pesticide shows potential adverse effects in subchronic studies suchas 90-day oral (Guideline 870.3100), 21-day repeated dermal toxicity (Guideline 870.3200), 90-day dermal toxicity (Guideline 870.3250), 90-day inhalation (Guideline 870.3465), reproductionand fertility effects (Guideline 870.3800), and chronic feeding (Guideline 870.4100). (G) The pesticide is found to be a mutagen (Guidelines 870.5100 to 870.5900) or an immunotoxicant(Guideline 870.7800). (H) Epidemiological or poisoning incidence data indicate adverse effects from handling the pesticide.16Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.17Protocols must be submitted to the Agency for approval before initiating a study.18Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.19Data reporting and calculations are required when exposure data are submitted.20Please see 40 CFR Sections 158 and/or 161 for additional information.21Please see 40 CFR Sections 158 and/or 161 for additional information.22Please see 40 CFR Sections 158 and/or 161 for additional information.23Please see 40 CFR Sections 158 and/or 161 for additional information.24Please see 40 CFR Sections 158 and/or 161 for additional information.25Please see 40 CFR Sections 158 and/or 161 for additional information.26Please see 40 CFR Sections 158 and/or 161 for additional information.Case # and Name:3034 Busan 77 (*)DCI Number:GDCI-069183-30193Page 4 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSTGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:L -O -S -Indoor food useResidential Indoor useFood handling/storage establishT -V -X -Commercial, institutional and indMedical premises and equipmenMaterials preservativesY - Industrial processes and waters27Please see 40 CFR Sections 158 and/or 161 for additional information.28Please see 40 CFR Sections 158 and/or 161 for additional information.29Please see 40 CFR Sections 158 and/or 161 for additional information.30Please see 40 CFR Sections 158 and/or 161 for additional information.31Please see 40 CFR Sections 158 and/or 161 for additional information.32Please see 40 CFR Sections 158 and/or 161 for additional information.33Aprotocol must be submitted for review and approval by the Agency prior to initiating this study. The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.34In accordance with 40 CFR 158.1020, OPPTS Guideline 875.1600 is required to accompany OPPTS Guidelines 875.1100 (Dermal OutdoorExposure), 875.1200 (Dermal Indoor Exposure),875.1300 (Inhalation Outdoor Exposure), and 875.1400 (Inhalation Indoor Exposure). When all four GLNs are listed, the registrant is only required to perform two of the four tests, one dermalexposure and one inhalation exposure.35Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subjects must be submitted for review byEPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the HumanStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.36Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subjects must be submitted for review byEPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the HumanStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.37Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subjects must be submitted for review byEPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the HumanStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.38Prior to initiation of the study, protocols must be submitted for review and approval by the Agency. Studies involving intentional exposure of human subjects must be submitted for review byEPA and then the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. Examples of proposed human study research can be found in various reviews provided by the HumanStudies Review Board (http://www.epa.gov/osa/hsrb/index.htm). The draft protocol must be submitted to the Agency within 90 days of receipt of this DCI.Case # and Name:3034 Busan 77 (*)DCI Number:GDCI-069183-30193Page 5 of 5[The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]Footnotes:Key:United States Environmental ProtectionAgency Washington, D.C. 20460FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTSTGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:L -O -S -Indoor food useResidential Indoor useFood handling/storage establishT -V -X -Commercial, institutional and indMedical premises and equipmenMaterials preservativesY - Industrial processes and waters39Please see 40 CFR Sections 158 and/or 161 for additional information.