United States Office of Prevention, Pesticides 739-R-05-007 Environmental Protection and Toxic Substances September 2005 Agency (751OC) Reregistration Eligibility Decision for 1,2-Benzisothiazolin-3-one (BIT) ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant: This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of the available data and public comments received related to the preliminary risk assessments for the antimicrobial l,2-benzisothiazolin-3- one (hereafter referred to as BIT). The enclosed Reregistration Eligibility Decision (RED) document was approved on September 29, 2005. Public comments and additional data received were considered in this decision. Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED) and risk management decision for BIT and its associated human health and environmental risks. A Notice of Availability will be published in the Federal Register announcing the publication of the RED. The RED and supporting risk assessments for BIT are available to the public in EPA's Pesticide Docket OPP-2005-0200 at: http://www.epa.gov/edocket. The BIT RED was developed through EPA's public participation process, published in the Federal Register on July 20, 2005, which provides opportunities for public involvement in the Agency's pesticide tolerance reassessment and reregistration programs. Developed with input from EPA's advisory committees and others, the public participation process encourages robust public involvement starting early and continuing throughout the pesticide risk assessment and risk mitigation decision making process. The public participation process encompasses full, modified, and streamlined versions that enable the Agency to tailor the level of review to the level of refinement of the risk assessments, as well as to the amount of use, risk, public concern, and complexity associated with each pesticide. Using the public participation process, EPA is attaining its strong commitment to both involve the public and meet statutory deadlines. Please note that the BIT risk assessment and the attached RED document concern only this particular pesticide. This RED presents the Agency's conclusions on the dietary, drinking water, occupational and ecological risks posed by exposure to BIT alone. This document also contains both generic and product-specific data that the Agency intends to require in Data Call- ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date. Additionally, for product-specific DCIs, the first set of required responses will be due 90 ------- days from the receipt of the DCI letter. The second set of required responses will be due eight months from the receipt of the DCI letter. As part of the RED, the Agency has determined that BIT will be eligible for reregistration provided that all the conditions identified in this document are satisfied, including implementation of the risk mitigation measures outlined in Section IV of the document. Sections IV and V of this RED document describe labeling amendments for end-use products and data requirements necessary to implement these mitigation measures. Instructions for registrants on submitting the revised labeling can be found in the set of instructions for product-specific data that accompanies this document. Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the Agency will continue to have concerns about the risks posed by BIT. Where the Agency has identified any unreasonable adverse effect to human health and the environment, the Agency may at any time initiate appropriate regulatory action to address this concern. At that time, any affected person(s) may challenge the Agency's action. If you have questions on this document or the label changes necessary for reregistration, please contact the Chemical Review Manager, Rebecca M. Miller, at (703) 305-0012. Sincerely, Frank T. Sanders Director, Antimicrobials Division ------- REREGISTRATION ELIGIBILITY DECISION for l,2-Benzisothiazolin-3-one (BIT) ListC CASE 3026 Approved By: Frank T. Sanders Director, Antimicrobials Division Attachment ------- Table of Contents BIT Reregistration Team i D Glossary of Terms and Abbreviations ii D Executive Summary iv D I. Introduction 1 D II. Chemical Overview 3 D A. Regulatory History 3 D B. Chemical Identification 4 D C. Use Profile 5 D III. Summary of BIT Risk Assessments 6 D A. Human Health Risk Assessment 6 D 1. Toxicity of BIT 6 D 2. FQPA Safety 9 D 3. Population Adjusted Dose (PAD) 10 D a. Acute PAD 10 D b. Chronic PAD 10 D 4. Dietary Exposure Assumptions 10 D 5. Dietary (Food) Risk Assessment 11 D a. Acute and Chronic Dietary Risk 11 D b. Dietary Exposure for Inert Ingredient Uses 12 D c. Dietary Risk from Drinking Water 15 D 6. Residential Risk for Active Ingredient Uses 15 D a. Toxicity 16 D b. Residential Handler Scenarios 17 D i. Exposure Scenarios, Data and Assumptions 17 D ii. Residential Handler Risk Estimates 18 D c. Residential Post-Application Exposure 19 D i. Exposure Scenarios, Data and Assumptions 19 D ii. Residential Post-Application Risk Estimates 19 D 7. Residential Risk for Inert Ingredient Uses 20 D 8. Aggregate Risk 22 D a. Acute and Chronic Aggregate Risks 22 D b. Short- and Intermediate- Term Aggregates Exposures D and Risks 23 D 9. Occupational Risk 26 D a. Occupational Toxicity 26 D b. Occupational Handler Exposure 27 D c. Occupational Handler Risk Summary 28 D d. Occupational Post-Application Exposure 29 D B. Environmental Risk Assessment 30 D 1. Environmental Fate and Transport 30 D 2. Ecological Risk 30 D 3. Listed Species Consideration 32 D ------- IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 34D A. Determination of Reregistration Eligibility 34 D B. Public Comments and Responses 34 D C. Regulatory Position 35 D 1. Food Quality Protection Act Findings 35 D a. "Risk Cup" Determination 35 D b. Determination of Safety to U.S. Population 35 D c. Determination of Safety to Infants and Children 35 D d. Cumulative Risks 36 D e. Endocrine Disrupter Effects 36 D 2. Tolerance Summary 37 D a. Tolerances Currently or Proposed to be Listed 37 D b. Codex Harmonization 37 D D. Regulatory Rationale 38 D 1. Human Health Risk Management 38 D a. Dietary (Food) Risk Mitigation 38 D b. Drinking Water Risk Mitigation 38 D c. Residential Risk Mitigation 38 D d. Occupational Risk Mitigation 39 D i. Handler Exposure 39 D ii. Post-Application Risk Mitigation 39 D 2. Environmental Risk Management 39 D 3. Listed Species Considerations 39 D a. The Endangered Species Program 39 D b. General Risk Mitigation 40 D V. What Registrants Need to Do 41 D A. Manufacturing Use Products 43 D 1. Additional Generic Data Requirements 43 D 2. Labeling for Technical and Manufacturing Use Products 43D B. End-Use Products 44 D 1. Additional Product-Specific Data Requirements 44 D 2. Labeling for End-Use Products 45 D VI. Appendices 46 D A. Table of Use Patterns for BIT 47 D B. Table of Generic Data Requirements and Studies Used to Make theD Reregistration Decision 62 D C. Technical Support Documents 67 D D. Bibliography Citations 68 D E. Generic Data Call-In 143D F. Product Specific Data Call-In 144D G. Batching of End-Use Products 145D H. List of All Registrants Sent the Data Call-In 150D I. List of Available Forms 151D ------- BIT Reregistration Team Health Effects Risk Assessment Melba Morrow Cassi Walls Tim McMahon Michelle Centra Timothy Leighton Environmental Fate and Ecological Assessment Najm Shamim Kathryn Montague Use Analysis Rebecca Miller Risk Management Rebecca Miller Registration Support Karen Angulo ------- GLOSSARY OF TERMS AND ABBREVIATIONS a.i. Active Ingredient aPAD Acute Population Adjusted Dose APHIS Animal and Plant Health Inspection Service ARTF Agricultural Re-entry Task Force BCF Bioconcentration Factor CDC Centers for Disease Control CDPR California Department of Pesticide Regulation CFR Code of Federal Regulations ChEI Cholinesterase Inhibition CMBS Carbamate Market Basket Survey cPAD Chronic Population Adjusted Dose CSFII USDA Continuing Surveys for Food Intake by Individuals CWS Community Water System DCI Data Call-In DEEM Dietary Exposure Evaluation Model DL Double layer clothing {i.e., coveralls over SL} DWLOC Drinking Water Level of Comparison EC Emulsifiable Concentrate Formulation EDSP Endocrine Disrupter Screening Program ED STAC Endocrine Disrupter Screening and Testing Advisory Committee EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. EP End-Use Product EPA U.S. Environmental Protection Agency EXAMS Tier II Surface Water Computer Model FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FOB Functional Observation Battery FQPA Food Quality Protection Act FR Federal Register GL With gloves GPS Global Positioning System HIARC Hazard Identification Assessment Review Committee IDFS Incident Data System IGR Insect Growth Regulator IPM Integrated Pest Management RED Reregistration Eligibility Decision LADD Lifetime Average Daily Dose LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause death in 50% of test animals, usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm. D LCO Lawn Care OperatorD LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals D when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of substance per unit weight of animal, e.g., mg/kg. LOAEC Lowest Observed Adverse Effect Concentration LOAEL Lowest Observed Adverse Effect Level LOG Level of Concern LOEC Lowest Observed Effect Concentration mg/kg/day Milligram Per Kilogram Per Day MOE Margin of Exposure MP Manufacturing-Use Product MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted. MRL Maximum Residue Level ------- N/A Not Applicable NASS National Agricultural Statistical Service NAWQA USGS National Water Quality Assessment NG No Gloves NMFS National Marine Fisheries Service NOAEC No Observed Adverse Effect Concentration NOAEL No Observed Adverse Effect Level NPIC National Pesticide Information Center NR No respirator OP Organophosphorus OPP EPA Office of Pesticide Programs ORETF Outdoor Residential Exposure Task Force PAD Population Adjusted Dose PCA Percent Crop Area PDCI Product Specific Data Call-In PDF USDA Pesticide Data Program PF10 Protections factor 10 respirator PF5 Protection factor 5 respirator PHED Pesticide Handler's Exposure Data PHI Pre-harvest Interval ppb Parts Per Billion PPE Personal Protective Equipment PRZM Pesticide Root Zone Model RBC Red Blood Cell RED Reregistration Eligibility Decision REI Restricted Entry Interval RID Reference Dose RPA Reasonable and Prudent Alternatives RPM Reasonable and Prudent Measures RQ Risk Quotient RTU (Ready-to-use) RUP Restricted Use Pesticide SCI-GROW Tier I Ground Water Computer Model SF Safety Factor SL Single layer clothing SLN Special Local Need (Registrations Under Section 24C of FIFRA) STORET Storage and Retrieval TEP Typical End-Use Product TGAI Technical Grade Active Ingredient TRAC Tolerance Reassessment Advisory Committee TTRS Transferable Turf Residues UF Uncertainty Factor USDA United States Department of Agriculture USFWS United States Fish and Wildlife Service USGS United States Geological Survey WPS Worker Protection Standard ill ------- EXECUTIVE SUMMARY The Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of public comments on the human health and environmental risk assessments for l,2-benzisothiazolin-3-one (hereafter referred to as BIT) and is issuing its risk management decision. The Agency has decided BIT is eligible for reregistration provided all measures outlined in this document are implemented. BIT is an antimicrobial that is used as an industrial preservative for the protection of water-based adhesives, caulks, sealants, grouts, spackling, ready-mixed cements, ready-mixed wallboard compounds, aqueous compositions such as emulsion paints, aqueous slurries, home cleaning and car care products, laundry detergents, fabric softeners, stain removers, inks, photographic processing solutions, paints and stains, titanium dioxide slurries, oil in water emulsions, latices, metalworking fluids, casein/rosin dispersions, textile spin-finish solutions, pesticide formulations, tape joint compound, leather processing solutions, preservation of fresh animal hides and skins, and for offshore and terrestrial gas/oil drilling muds and packer fluids preservation. l,2-Benzisothiazolin-3-one is also used as an inert ingredient in a variety of products as a materials preservative. Exposures and risks from the use of products containing l,2-benzisothiazolin-3-one as both the active and inert ingredients are assessed in this reregistration eligibility decision (RED). End-use products are formulated as either a soluble, ready-to-use, or flowable concentrates (all of which are considered to be liquids). Overall Risk Summary The Agency's human health risk assessment indicates few risks of concern. Acute and chronic dietary exposure is below the agency's level of concern for general U.S. populations and all population subgroups. Likewise, it was concluded that risk from exposure of BIT in drinking water would also not represent a risk of concern because it is not likely to be in drinking water sources at substantial concentrations. This is based on the fact that BIT readily biodegrades, is applied to crops via inert use in small amounts and is only likely to come into contact with soil/surface water via paint uses in small amounts. The acute and chronic aggregate dietary risk assessment estimates associated with the use of BIT as an inert or active ingredient are below the Agency's level of concern. Short and intermediate term residential post-application and handler exposures (dermal, inhalation or incidental oral) from hard surface residues did not exceed the Agency's level of concern. For residential exposure and risk, the toddler post-application dermal exposure scenario from residues remaining on pets from the inert use, the margin of exposure (MOE) is below the targeted MOE, indicating that this scenario is a risk of concern. For aggregate exposure, the risk estimates associated with BIT are below the Agency's level of concern. In cases where an aggregate risk index (ART) was used to assess risk because of the different uncertainty factors for oral, dermal and inhalation exposure scenarios, the risk indices suggested that there is reasonable certainty of no harm from using products containing BIT. Based on the information provided, inhalation exposures were not considered to be of concern with regard to inhalation risk from occupational handler scenarios; however the dermal MOE indicated that the dermal risk for occupational handlers was below the target MOE for one ------- scenario, handlers of BIT-containing paint using an airless sprayer. While the inhalation risk may be an underestimation based on extrapolation from an oral study, the dermal risk is based on a number of conservative assumptions and are not of concern. Dermal and inhalation exposures to bystanders from the occupational use of BIT are also expected to be minimal. The indoor uses of BIT make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur. Facilities using BIT for indoor industrial applications are required to have NPDES permits before discharging effluents into receiving waters. l,2-Benzisothiazolin-3-one's ready biodegradation in soil and small application amount greatly reduce the exposure potential for terrestrial and aquatic organisms. Run-off into surface water from pesticidal uses is likely to be low and it is not likely to be present in water sources at substantial concentrations. The ecological risks from the use of BIT suggest that because of the high toxicity of BIT to green algae and invertebrate species, adverse effects to the environment could result from contamination from BIT-treated oil recovery fluids. Dietary Risk The Agency has conducted a dietary exposure and risk assessment for use of 1,2- benzisothiazolin-3-one as a pulp and paper mill slimicide, and a preservative in paper coatings and paper adhesives, all of which may end in indirect food contact scenarios. For both the acute and chronic dietary exposure, the risk is highest for children (21.8% of the acute and chronic PAD). For an adult, the acute and chronic dietary exposure is 9.4% of the acute and chronic PAD. All dietary exposures calculated are below the Agency's level of concern (100% of aPAD or cPAD) for non-cancer risk. Furthermore, given the conservative nature of the assumptions used in the inert dietary exposure and risk assessment, risks of concern from food are not likely from the use of l,2-benzisothiazolin-3-one as inert ingredients in pesticide products. A dietary cancer risk assessment could not be performed as there are no carcinogenicity data for 1,2- benzisothiazolin-3-one. Drinking Water Risk Based on environmental fate data, l,2-benzisothiazolin-3-one binds moderately with soil and may potentially move with the soil during rainfall events and reach surface waters. Although, l,2-benzisothiazolin-3-one has been shown to be hydrolytically stable with a half life of > 30 days, it breaks down fairly quickly in aerobic soils. Outdoor use patterns of 1,2- benzisothiazolin-3-one which may lead to contact with soil and/or surface water include: 1) the application of agricultural pesticides that contain l,2-benzisothiazolin-3-one as an inert ingredient, and 2) the application of paints that contain l,2-benzisothiazolin-3-one. Considering l,2-benzisothiazolin-3-one readily biodegrades and the small amount (0.02 Ibs. per acre) that may be applied to crops via the inert use and the small amount likely to come into contact with soils/surface waters via the paint use, l,2-benzisothiazolin-3-one is not likely to be present in drinking water sources at substantial concentrations. v ------- |