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 2070-0107OMB Approval 2070-0057United States Environmental ProtectionAgency Washington, D.C. 20460DATA CALL-IN RESPONSE3. Date and Type of DCI and NumberGENERIC11-Aug-2008ID # GDCI-107002-278902. Case # and Name3023 AzadioxabicyclooctaneChemical # and Name1070025-Hydroxymethyl-1-aza-3,7-dioxabicyclo(3.3.0)octane5. 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.N.A.N.A.10. Name of Company11. Phone Number9. Date8. Certification I certify that the statements made on this form 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's Authorized Representative__________________________________5-Hydroxymethyl-1-aza-3,7-dioxabicyclo(3.3.0)octaneINSTRUCTIONS: 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 1OMB Approval 2070-0107OMB Approval 2070-0057United States Environmental ProtectionAgency Washington, D.C. 20460REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE3. Date and Type of DCI and NumberID #GENERIC11-Aug-2008GDCI-107002-278902. Case # and Name3023 Azadioxabicyclooctane107002Chemical # and Name8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321Applicator Exposure Data Requirements (Antimicrobial)(13 ,14 ,15)875.120012K, XDermal exposure--Indoor(9 ,10 ,11,12)875.140012K, XInhalation exposure--indoor(8)875.160012K, XApplication exposure monitoring data reportingPostapplication Exposure Data Requirements (Antimicrobial)(7)875.280012K, XDescription of human activityToxicology Data Requirements (Antimicrobial)(1 ,2)870.260012MP; TGAIK, XSkin sensitization(3 ,4 ,5 ,6)870.420048TGAIK, XCarcinogenicity12. Name of Company13. Phone NumberSignature and Title of Company's Authorized 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. DateCase # and Name:3023 AzadioxabicyclooctaneDCI Number:GDCI-107002-27890Page 1 of 2[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 REQUIREMENTSMP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:K -X -ResidentialMaterials preservatives1For the six acute studies conducted with the end-use product, the test must be conducted using the product as formulated for sale and distribution. If the product is intended and labeled to bediluted for use, the applicant may also wish to conduct certain studies using the highest diluted concentration (i.e. lowest dilution rate) permitted by the labeling.2Required if repeated dermal exposure is likely to occur under conditions of use.3If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same species, conducted in accordance withGuideline 870.3100, may be required to evaluate potential to produce preneoplastic lesions.4For low exposure antimicrobials, a carcinogenicity study in two species is required if any of the following criteria are met:(i) The weight of evidence indicates carcinogenic potential of the activeingredient or any of its metabolites, transformation products or impurities based upon consideration of whether the substance:(A) Is structurally related to a recognized carcinogen. (B) Causesmutagenic effects as demonstrated by in vitro or in vivo testing. (C) Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to neoplasticchange. (ii) Use of the pesticide product is likely to result inhuman exposure over a substantial portion of the human life span which is significant in terms of the frequency, magnitude, orduration of exposure.5If the requirement for a carcinogenicity study in any species is modified or waived for any reason, then a subchronic 90-day oral study in the same species, conducted in accordance withGuideline 870.3100, may be required to evaluate potential to produce preneoplastic lesions.6For low exposure antimicrobials, a carcinogenicity study in two species is required if any of the following criteria are met:(i) The weight of evidence indicates carcinogenic potential of the activeingredient or any of its metabolites, transformation products or impurities based upon consideration of whether the substance:(A) Is structurally related to a recognized carcinogen. (B) Causesmutagenic effects as demonstrated by in vitro or in vivo testing. (C) Produces a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in subchronic studies that may lead to neoplasticchange. (ii) Use of the pesticide product is likely to result inhuman exposure over a substantial portion of the human life span which is significant in terms of the frequency, magnitude, orduration of exposure.7The required description of human activity data include data such as frequency and duration of exposure to evaluate the potential differences in exposures of different subpopulations (e.g. adultsand children), and to determine how specific postapplication activity patterns affect exposure levels.8Data reporting and calculations are required when exposure data are submitted.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.Case # and Name:3023 AzadioxabicyclooctaneDCI Number:GDCI-107002-27890Page 2 of 2[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 REQUIREMENTSMP; TGAI = Manufacturing Use Product; Technical Grade Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]10Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.11Protocols must be submitted to the Agency for approval before initiating a study.12Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.13The 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.14Protocols must be submitted to the Agency for approval before initiating a study.15Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.United States Environmental ProtectionAgency Washington, D.C. 20460LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICECo. Nr.Company NameAgent ForAddressCity & StateZipCase # and Name:3023,AzadioxabicyclooctaneINTERNATIONAL SPECIALTYPRODUCTS1361 ALPS RD.WAYNENJ074701529