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 NumberGENERIC03-Mar-2008ID # GDCI-098901-275482. Case # and Name3026 Benzisothiazolin-3-oneChemical # and Name0989011,2-Benzisothiazolin-3-one5. 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.N.A.N.A.N.A.N.A.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__________________________________1,2-Benzisothiazolin-3-oneINSTRUCTIONS: 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 #GENERIC03-Mar-2008GDCI-098901-275482. Case # and Name3026 Benzisothiazolin-3-one098901Chemical # and Name8. TimeFrame(Months)9. RegistrantResponse7. TestSubstance6. UsePatternPROTOCOLProgressReports321Applicator Exposure Data Requirements (Antimicrobial)(9 ,10 ,15)875.120012TGAIEE, K, M, Q, XDermal exposure--Indoor(1 ,2 ,3 ,16)875.140012EPEE, K, M, Q, XInhalation exposure--indoor(8 ,13 ,17)875.160012EE, K, M, Q, XApplication exposure monitoring data reportingPostapplication Exposure Data Requirements (Antimicrobial)(11 ,14 ,18)875.280012EE, K, M, Q, XDescription of human activityToxicology Data Requirements (Antimicrobial)(4 ,5 ,6 ,7,12)870.13008TGAIEE, K, M, Q, XAcute inhalation toxicity870.420048TGAIEE, K, M, Q, 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:3026 Benzisothiazolin-3-oneDCI Number:GDCI-098901-27548Page 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 REQUIREMENTSEP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:K -M -Q -ResidentialIndoor nonfood useResidential outdoor useX -EE -Materials preservativesIndoor use1Required for outdoor uses when that is the primary use or if outdoor uses are expected to result in greater exposure than indoor uses.2Protocols must be submitted to the Agency for approval before initiating a study.3Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.4For 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.5Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas, vapor, aerosol or particulates).6The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any orall of these studies may be granted when the applicant candemonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.7Required when the product consists of, or under conditions of use will result in, an inhalable material (e.g. gas, volatile substances, or aerosol particulate).8Data reporting and calculations are required when exposure data are submitted.9Protocols must be submitted to the Agency for approval before initiating a study.10Required for indoor uses such as aquaria when the Agency determines such uses are likely to result in greater exposure than outdoor uses.11The 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.12The requirement for an acute inhalation toxicity study was waived at the time of registration (1973) for the technical grade powder form of the active ingredient based on particle size (less than2% of the test material with aerodynamic diameter of < 15 microns). Since that time, waiver criteria have been updated based on advances in inhalation toxicology. The newer criteria state thata registrant requesting a waiver on the basis of particle size must demonstrate that their product contains large, non-inhalable particles which are resistant to attrition and that a particle isessentially non-inhalable if > 99% of the particles by mass are >100 um in diameter. The Agency's information indicates a large proportion of the particles of the technical powder havediameters less than 100 microns.13If the exposure monitoring data reporting is not submitted in conjunction with the indoor dermal and inhalation applicator exposure studies, the Agency may not be able to utilize the studies tothe fullest extent to conduct its human health exposure and risk assessments. The lack of such data could cause the Agency touse inadequate surrogate data, resulting in a high-end screeninglevel risk assessment and a potential overestimation of exposures.Case # and Name:3026 Benzisothiazolin-3-oneDCI Number:GDCI-098901-27548Page 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 REQUIREMENTSEP = End Use Product [EP]; TGAI = Technical Grade Active Ingredient [TGAI]Use Categories Key:K -M -Q -ResidentialIndoor nonfood useResidential outdoor useX -EE -Materials preservativesIndoor use14If review and evaluation of the descriptions of human activity data indicate that only closed-systems are used for mixing/loading and applying metal working fluids, then the need for acarcinogenicity study is negated. Therefore, submission of acceptable human activity data demonstrating the metal working fluid scenario for BIT is an enclosed system will eliminate asignificant cost and burden for the registrant (specifically, the costs associated with generating the carcinogenicity data).For the other use scenarios, descriptions of human activity data will allowthe Agency to refine its risk assessment and make decisions using fewer assumptions and more reliable data.15The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these data requirements. Since these studiesinvolve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for reviewand approval. The AEATF protocols are currentlyscheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved foruse, the Agency understands that the time-frames established inthis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not practical to submit the data within thespecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protocol to the HSRB for review and approvalprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.16The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these data requirements. Since these studiesinvolve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for reviewand approval. The AEATF protocols are currentlyscheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved foruse, the Agency understands that the time-frames established inthis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not practical to submit the data within thespecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protocol to the HSRB for review and approvalprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.17The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these data requirements. Since these studiesinvolve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for reviewand approval. The AEATF protocols are currentlyscheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved foruse, the Agency understands that the time-frames established inthis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not practical to submit the data within thespecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protocol to the HSRB for review and approvalprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.18The Antimicrobial Exposure Assessment Task Force (AEATF) is in the process of developing study protocols for studies that would likely fulfill these data requirements. Since these studiesinvolve testing of human subjects, the protocols must be submitted to the Agency's Human Studies Review Board (HSRB) for reviewand approval. The AEATF protocols are currentlyscheduled for evaluation by the HSRB on April 9 - 10, 2008. Since it is undetermined when these protocols will be approved foruse, the Agency understands that the time-frames established inthis DCI may not be practical for the ORE exposure studies. For these studies, the registrants must submit a written time extension request if it is not practical to submit the data within thespecified time-frames. In addition, a registrant may choose to conduct the studies individually. In that case, the registrants must submit each study protocol to the HSRB for review and approvalprior to conducting the study. Written time extension requests would need to be submitted as needed for each study.