United States Prevention, Pesticides EPA739 R 05 003 Environmental Protection and Toxic Substances September 2005 Agency ( 7510C)

Reregistration Eligibility Decision for PHMB 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 poly( hexamethylenebiguanide) hydrochloride ( PHMB). The Reregistration Eligibility Decision ( RED) was approved in the form of a decision memorandum which summarized the regulatory decision for PHMB on September 30, 2004. 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 PHMB 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 PHMB are available to the public in EPA's Pesticide Docket OPP 2004 0305 at: http:// www. epa. gov/ edockets.

The PHMB RED was developed through EPA's public participation process, published in the Federal Register on September 10, 2004, which provides opportunities for public involvement in the Agency's pesticide tolerance reassessment and reregistration programs. Developed in partnership with USDA and 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 PHMB 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 PHMB 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 PHMB will be eligible for reregistration provided that all the conditions identified in this document are satisfied, including implementation of the risk mitigation measure outlined in Section IV of the document. Sections IV and V of this RED document describe the labeling amendments for end use products and data requirements necessary to implement this mitigation measure. 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 PHMB. 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 relevant to this reregistration decision, please contact the Chemical Review Manager, Jennifer Slotnick, at ( 703) 305 0601. For questions about product reregistration and/ or the Product DCI that accompanies this document, please contact Adam Heyward at ( 703) 308 6422.

Sincerely,

Frank T. Sanders Director, Antimicrobials Division REREGISTRATION ELIGIBILITY DECISION for PHMB List C CASE 3122 Approved By:

Frank T. Sanders Director, Antimicrobials Division September 29, 2005 Attachment Table of Contents PHMB Reregistration Team                   ...   i Glossary of Terms and Abbreviations              ...    ii Executive Summary                      .  .... iv I. Introduction                           .. 1 II. Chemical Overview                       . ... 3 A. Regulatory History                    .. ... 3 B. Chemical Identification                   ... 3 C. Use Profile                        ... 4 III. Summary of PHMB Risk Assessments               ... 7 A. Human Health Risk Assessment               ... 7 1. Toxicity of PHMB                   ... 7 2. FQPA Safety Factor                   10 3. Population Adjusted Dose ( PAD)            ... 10 a. Acute PAD                    10 b. Chronic PAD                   11 4. Exposure Assumptions                  11 5. Dietary Risk Assessment                . 11 a. Dietary Risk from Food             .. 11 b. Dietary Risk from Drinking Water         .. 12 6. Residential Risk Assessment ...              12 a. Residential Toxicity        ..   ..   . 12 b. Residential Handlers           ..  .. .. 13 i. Exposure Assessment .           . 13 ii. Risk Assessment       .  .    . 14 b. Residential Post Application ..           14 i. Exposure Assessment .           . 14 ii. Risk Assessment       .  .    . 15 7. Aggregate Risk                    . 16 a. Short and Intermediate Term Aggregate Risk   ... 16 b. Chronic Aggregate Risk            ... .. 18 8. Occupational Risk                  ... 18 a. Occupational Toxicity              . 19 b. Occupational Handler Exposure           19 c. Occupational Handler Risk Summary       ... 20 9. Human Incident Data        ...        ... 20 B. Environmental Risk Assessment               .. 21 1. Environmental Fate and Transport           ... 21 2. Ecological Risk                    . 21 a. Toxicity ( Hazard) Assessment ...           22 b. Exposure and Risk                . 22 c. Risk to Listed Species       .       . 23 IV. Risk Management, Reregistration, and Tolerance Reassessment Decision  24 A. Determination of Reregistration Eligibility           . 24 B. Public Comments and Responses               .. 24 C. Regulatory Position                      26 1. Food Quality Protection Act Findings          ... 26 a. " Risk Cup" Determination            . 26 b. Determination of Safety to U. S. Population     .. 26 c. Determination of Safety to Infants and Children   . 27 d. Endocrine Disruptor Effects           .. 27 e. Cumulative Risks                . 28 2. Tolerance Summary                   28 D. Regulatory Rationale                    .. 28 1. Human Health Risk Management            . 28 a. Dietary ( Food) Risk Mitigation          .. 28 b. Drinking Water Risk Mitigation           28 c. Residential Risk Mitigation             29 i. Handler Risk Mitigation           . 29 ii. Post Application Risk Mitigation  .    . 29 d. Occupational Risk Mitigation            29 i. Handler Risk Mitigation           . 29 ii. Post Application Risk Mitigation .     . 29 2. Environmental Risk Management          ... .. 29 3. Other Labeling Requirements               29 4. Listed Species Considerations          ..   .. 29 a. The Endangered Species Act  .         . 29 b. General Risk Mitigation    ...        .. 30 V. What Registrants Need to Do                     31 A. Manufacturing Use Products                  33 1. Additional Generic Data Requirements           33 2. Labeling for Technical and Manufacturing Use Products  .. 34 B. End Use Products                   ...   34 1. Additional Product Specific Data Requirements    ......... 34 2. Labeling for End Use Products             .. 34 a. Label Changes Summary Table          . 35 VI. Appendices                           . 39 A. Table of Use Patterns for PHMB                . 40 B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision              ... 59 C. Technical Support Documents                .. 65 D. Bibliography Citations                   ... 67 E. Generic Data Call In                    .. 74 F. Product Specific Data Call In                  75 G. Batching of End Use Products                .. 76 H. List of All Registrants Sent the Data Call In          ... 80 I. List of Available Forms                   ... 81 i PHMB Reregistration Team Health Effects Risk Assessment Jonathan Chen Timothy Leighton Tim McMahon Najm Shamim Cassi Walls Ecological Risk Assessment Kathryn Montague Environmental Fate Risk Assessment Najm Shamim Registration Support Adam Heyward Lisa McKelvin Risk Management Jennifer Slotnick Ben Chambliss ii 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 Disruptor Screening Program EDSTAC Endocrine Disruptor 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/ l, mg/ kg or ppm. LCO Lawn Care Operator LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals 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 LOC 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 iii 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 PDP 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 RfD 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 iv 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 PHMB and is issuing its risk management decision. The Agency has decided PHMB is eligible for reregistration provided all measures outlined in this document are implemented. PHMB is used as a fungicide, algicide, and sanitizer in swimming pools; preservative for cut flowers; materials preservative; bacteriostat in industrial processes and water systems; and hard surface disinfectant ( food and non food contact surfaces). End use products are formulated as soluble concentrates, as solids, as ready to use solutions, and in water soluble packaging. The product with the impregnated wipe formulation was cancelled in July 2005.

Overall Risk Summary The Agency's human heath risk assessment indicates only one risk of concern for occupational handlers. An acute dietary risk estimate was completed for females 13 50 years old, the only population subgroup with an acute toxicity endpoint, and is below the Agency's level of concern. Chronic dietary risk estimates were provided for the general U. S. population and all population subgroups. All chronic dietary risk estimates are below the Agency's level of concern. As none of the uses associated with PHMB are expected to impact either surface or ground water resources, no drinking water assessment was performed. When considering aggregate risk from dietary and residential exposures, risk estimates are below the Agency's level of concern.

To address occupational exposure, dermal and inhalation risks were assessed for handlers. Scenarios involving pour liquid for drilling muds and workover fluids showed a risk above the Agency's level of concern. In order to achieve MOEs above the target level, these scenarios must use mitigation measures such as metering pump systems. In addition, since the inhalation MOE for this scenario falls below the MOE of 1,000, when the additional route toroute extrapolation uncertainty factor is applied, an inhalation study will be required to confirm these findings.

An environmental risk assessment was also conducted for PHMB. Due to limited potential for environmental exposure, environmental risks are below the Agency's level of concern.

Dietary Risk Acute and chronic dietary ( food) risks are below EPA's level of concern for the general U. S. population and all population subgroups. A screening level acute dietary risk assessment was conducted for PHMB food uses. Risk estimates are provided for females 13 50 years old, the only population subgroup with an acute toxicity endpoint of concern. Risk estimates for the use with the highest exposures were 9% of the aPAD and, therefore, were not of concern.

The chronic dietary risk assessment concludes that for all included use sites, the chronic risk estimates are below the Agency's level of concern for the general U. S. population (< 10% of the cPAD) and all population subgroups ( 37% of the cPAD for children). Risks, therefore, are not of concern and no mitigation measures are necessary. v Drinking Water Risk None of the uses associated with PHMB are expected to impact either surface or ground water resources. Therefore, no drinking water assessment was performed.

Residential Risk Residential handler and post application exposure scenarios were assessed using surrogate exposure data, maximum label rates, and standard assumptions. All margins of exposure ( MOEs) from dermal and inhalation exposure for residential handlers are above the target MOE of 100 and, therefore, not of concern. For post application dermal and incidental ingestion ( oral) exposures, MOEs were below the Agency's level of concern. No residential risk mitigation is necessary.

Aggregate Risk The aggregate risk assessment integrates the assessments conducted for dietary and residential exposure. Using the Aggregate Risk Index ( ARI) method, aggregate calculations were performed for adults and children. The ARIs are greater than 1.2 for children and 5.4 for adults. These risks are below the Agency's level of concern ( ARI< 1), and no mitigation measures are necessary to reduce risks from aggregate exposures.

Occupational Risk To address occupational exposure, dermal and inhalation risks were assessed for handlers. Only one scenario for occupational handlers showed a risk above the Agency's level of concern. The dermal MOE of 74 for scenarios involving pour liquid for drilling muds and workover fluids is below the target MOE of 100 and, therefore, is of concern. In order to achieve MOEs above the target level ( i. e., greater than 100), scenarios involving drilling muds and workover fluids must use mitigation measures such as metering pump systems. In addition, since the inhalation MOE for this scenario falls below the MOE of 1,000, when the additional route to route extrapolation uncertainty factor is applied, an inhalation study will be required to confirm these findings. At this time, EPA does not foresee post application exposures for the occupational uses of PHMB.

Ecological Risk The Agency conducted an environmental risk assessment to determine the potential impact of PHMB use on non target terrestrial and aquatic organisms. Environmental exposure modeling was not conducted for PHMB because its uses are not likely to result in significant outdoor exposure. The uses of PHMB make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur. The Agency expects no effects to listed species or critical habitat and therefore makes a " No Effect" determination for PHMB. However, the high toxicity of PHMB to fish and aquatic invertebrates is of concern in the event of a spill or misuse of the product. vi Regulatory Decision The Agency has completed its review and has determined that the data are sufficient to support reregistration of all supported products containing PHMB. The Agency is issuing this RED for PHMB, as announced in a Notice of Availability published in the Federal Register. The RED and supporting risk assessment for PHMB are available to the public in EPA's Pesticide Docket OPP 2004 0305 at http:// www. epa. gov/ edockets. This RED document includes guidance and time frames for making any necessary label changes for products containing PHMB.

Summary of Mitigation Measures The Agency has determined that PHMB is eligible for reregistration provided the mitigation measure described in this document and the label changes included in Table 12 in Section V of the RED are implemented.

Occupational Risk EPA determined that the greatest potential for exposure appears to be the inhalation and dermal occupational scenarios involving pour liquid for drilling muds and workover fluids. Using an open pour scenario, these risks are of concern to the Agency. In order for risks to drop below the Agency's level of concern, scenarios involving drilling muds and workover fluids must use mitigation measures such as metering pump systems.

Data Requirements Additional confirmatory data is required to complete the reregistration of PHMB. A complete list of data gaps is presented Section V and Appendix B ( Table of Generic Data Requirements). In addition, product specific data is required for all products containing PHMB as described in Section V of this document. 1 I. Introduction The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) was amended in 1988 to accelerate the reregistration of products with active ingredients registered prior to November 1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the development and submission of data to support the reregistration of an active ingredient, as well as a review of all submitted data by the U. S. Environmental Protection Agency ( EPA or the Agency). Reregistration involves a thorough review of the scientific database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards arising from the currently registered uses of the pesticide; to determine the need for additional data on health and environmental effects; and to determine whether or not the pesticide meets the " no unreasonable adverse effects" criteria of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 ( FQPA) was signed into law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will be initiated through this reregistration process. The Act also requires that by 2006, EPA must review all tolerances in effect on the day before the date of the enactment of the FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act ( FFDCA) to require a safety finding in tolerance reassessment based on factors including consideration of cumulative effects of chemicals with a common mechanism of toxicity. This document presents the Agency's revised human health and ecological risk assessments and the Reregistration Eligibility Decision ( RED) for poly( hexamethylenebiguanide) hydrochloride ( PHMB).

PHMB is an antimicrobial used in several types of applications, including as a fungicide, algicide, and sanitizer in swimming pools; preservative for cut flowers; materials preservative; bacteriostat in industrial processes and water systems; and hard surface disinfectant. The registrant for PHMB has indicated that about 95 percent of the use of this chemical is for pools and spas. The hard surface disinfectant use may be on food and non food contact surfaces in or on agricultural premises and equipment; commercial, industrial, and institutional premises and equipment; residential contents and premises; and medical premises and equipment.

The Agency has concluded that the FQPA Safety Factor for PHMB should be removed ( equivalent to 1X) based on: ( 1) there is no concern for developmental neurotoxicity resulting from exposure to PHMB because there is no evidence PHMB will induce neurotoxic effects; ( 2) there is no quantitative or qualitative evidence of increased susceptibility to the fetus following in utero exposure in the prenatal developmental toxicity studies or to the offspring when adults are exposed in the two generation reproductive study; and ( 3) the risk assessment does not underestimate the potential exposure for infants and children.

Risks summarized in this document are those that result only from the use of the active ingredients PHMB. The Food Quality Protection Act ( FQPA) requires that the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common toxic mechanism could lead to the same adverse health effect that would occur at a higher level of exposure to any of the substances 2 individually. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for PHMB and any other substances. PHMB does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that PHMB has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative.

This document presents the Agency's decision regarding the reregistration eligibility of the registered uses of PHMB. In an effort to simplify the RED, the information presented herein is summarized from more detailed information which can be found in the technical supporting documents for PHMB referenced in this RED. The revised risk assessments and related addenda are not included in this document, but are available in the Public Docket at http:// www. epa. gov/ edocket.

This document consists of six sections. Section I is the introduction. Section II provides a chemical overview, a profile of the use and usage of PHMB, and its regulatory history. Section III, Summary of PHMB Risk Assessments, gives an overview of the human health and environmental assessments, based on the data available to the Agency. Section IV, Risk Management, Reregistration, and Tolerance Reassessment Decision, presents the reregistration eligibility and risk management decisions. Section V, What Registrants Need to Do, summarizes the necessary label changes based on the risk mitigation measures outlined in Section IV. Finally, the Appendices list all use patterns eligible for reregistration, bibliographic information, related documents and how to access them, and Data Call In ( DCI) information. 3 II. Chemical Overview A. Regulatory History PHMB was first registered in the United States in 1982 as an active ingredient. Currently, there are 17 products containing PHMB ( two technical products and 15 end use products) registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) for use as algaecides, bacteriocides/ bacteriostats, fungicides/ fungistats, microbicides/ microbiostats, disinfectants, regulators, and sanitizers.

B. Chemical Identification Technical PHMB X  (( CH2) 3  NH  C  NH  C  NH  ( CH2) 3) n  X       NH NH . HCl where X = HCl. NH2  ( CH2) 3 OR X =  ( CH2) 3  NH  C  NH  CN    NH OR X =  ( CH2) 3  NH  C  NH2 . HCl    NH Figure 1. Molecular Structure of PHMB Common name: Poly( hexamethylenebiguanide) hydrochloride Chemical name: Poly( iminoimidocarbonyliminoimidocarbonyliminohexamethylene hydrochloride Chemical family: Guanidine Empirical formula: C8 H17 N5 HCl CAS Registry No.: 32289 58 0 Case number: 3122 OPP Chemical Code: 111801 4 Molecular weight: 219.5 Other names: PHMB, Vantocil 1B, Baquacil, Baquacil SB, Cosmoquil CQ Basic manufacturers: Arch Chemicals, Inc. Mareva, Inc.

Chemical properties: PHMB is a very faint yellow, mobile liquid. Since PHMB is a liquid, it has no melting point. It has a boiling point of 100.20C, and decomposition begins at 205  2100C. PHMB has a specific gravity of 1.04 at 20oC.

C. Use Profile The following is information on the uses of PHMB products, currently registered as of September 30, 20041, and an overview of use sites and application methods. A detailed table of the uses of PHMB eligible for reregistration is contained in Appendix A.

Type of Pesticide: Algicide, bacteriostat/ bacteriocide, fungistat/ fungicide, microbiostat/ microbiocide, disinfectant, regulator, and sanitizer Summary of Use:

Food: Hard surface disinfectant uses on kitchen countertops, high chairs, refrigerators, and microwave ovens are indirect food uses, as there surfaces have the potential to come into contact with food.

Public Health: Hard surface disinfectant: For use in residential, healthcare, industrial and institutional settings such as hospitals, nursing homes, day care centers, nurseries, hotels, schools, airplanes, boats, buses, campers, cars, railroad trains, taxicabs, campgrounds, restaurants, animal laboratories, veterinary offices, kennels, dental offices, health clubs, farm and livestock premises and mushroom house premises. May be used on hard, non porous surfaces such as tables, countertops, stovetops, sinks, cabinets, refrigerators, microwave ovens, high chairs, tubs, floors, glazed tiles, urinals, diaper pails and other bathroom surfaces, garbage cans, walls, floors, stainless steel surfaces, kennel runs, pet areas, sealed stones, glazed ceramics, playground equipment, picnic tables and the coils of air conditioning units.

Aquatic non food residential sanitizer: For use in swimming pool, spa and hot tub water systems.

1 The impregnated wipe disinfectant, EPA Reg. No. 50096 1, was cancelled in July 2005. Its exclusion in the risk assessment would not change the risk levels of concern; therefore, the document was not revised to remove it. 5 Other Non food: Terrestrial non food microbiostat and preservative: For use on ornamental flowering plants ( cuttings or stored).

Indoor non food materials preservative: For use in the preservation of electrocoat resins in addition to aqueous industrial chemicals such as reagents, oil in water emulsions, water in oil emulsions, cellulose solutions, silicone emulsions and silicone dispersions, aqueous mineral slurries such as calcium carbonate and titanium dioxide as well as polymer latices such as polyvinyl acetate and polyvinyl alcohol.

For the preservation of textiles and cellulosic materials such as carpet, curtains, mops, dishcloths, wipes, sponges, tissues and non food contact paper products.

For the preservation of leather, fresh animal hides and skins prior to or during processing.

For the control of microorganisms in aqueous adhesives such as animal glues, latex adhesives and other synthetic and protein based glues.

Terrestrial non food bacteriostat: For the control of microorganisms and bacteria in drilling muds and packer fluids in addition to workover fluids.

Indoor non food bacteriostat: For the control of microorganisms and bacteria in oil field injection water and tunnel pasteurization water.

Target Pests: Slime forming bacteria, deterioration/ spoilage bacteria, animal pathogenic bacteria ( G and G+ vegetative), pseudomonas spp, animal pathogenic fungi, mold/ mildew, algae.

Formulation Types: Soluble concentrate/ solid, impregnated wipes, ready to use solution, and water soluble packaging.

Method and Rates of Application:

Equipment: The end use products are added during the manufacturing process of treated articles and materials. Poly( hexamethylenebiguanide) hydrochloride formulations are added directly to water in swimming pools, spas, and cut flower applications, as well as in oil field injection waters and workover fluids. Impregnated wipes are dampened with water prior to use.

Application Rates: For details about specific use sites for PHMB, refer to Appendix A. 6   Use 1 to 50 lbs. of end use formulation to 10,000 lbs. of product to produce a 100 to 5000 ppm solution for the preservation of reagents, oil in water emulsions, water in oil emulsions, cellulose solutions, silicone emulsions and silicone dispersions.   Use 5 to 50 lbs. of end use formulation to 10,000 lbs. of product to produce a 500 to 5000 ppm solution for the preservation of aqueous mineral slurries such as calcium carbonate and titanium dioxide, as well as polymer latices, such as polyvinyl acetate and polyvinyl alcohol, and adhesives, such as animal glues, latex adhesives and other synthetic and protein based glues.   Use 1 to 30 lbs. of end use formulation to 10,000 lbs. of product to produce a 100 to 3000 ppm solution for the preservation of leather and fresh animal hides and skins prior to or during processing.   Use 13 fl. oz. to 1 gal. of end use formulation to 1000 gals. of water for the preservation of tunnel pasteurization waters.   For non porous surface disinfection, spray end use product on surface until wet. Surface must remain wet for 10 minutes before wiping dry. Rinse food contact surfaces with potable water prior to reuse.   For sanitizing pool water, use enough end use product to give a concentration of 50 ppm PHMB ( 58 64 oz. per 10,000 gals.) for freshly filled pools. To maintain or raise level of end use product add at a rate of one pint per 10,000 gals. of water. For pool water sanitizer tablets, add one tablet per approximately 5500 gals. of water.

Use Classification: General use. 7 III. Summary of PHMB Risk Assessments The purpose of this summary is to assist the reader by identifying the key features and findings of these risk assessments and to help the reader better understand the conclusions reached in the assessments. The human health and ecological risk assessment documents and supporting information listed in Appendix C were used to formulate the safety finding and regulatory decision for PHMB. While the risk assessments and related addenda are not included in this document, they are available from the OPP Public Docket and may also be accessed on the Agency's website at http:// epa. gov/ dockets. Hard copies of these documents may be found in the OPP public docket under docket number OPP 2004 0220. The OPP public docket is located in Room 119, Crystal Mall II, 1801 Bell Street, Arlington, VA, and is open Monday through Friday, excluding Federal holidays, from 8: 30 a. m. to 4: 00 p. m.

A. Human Health Risk Assessment 1. Toxicity of PHMB A brief overview of the toxicity studies used for determining endpoints in the risk assessments are outlined below in Table 1. Further details on the toxicity of PHMB can be found in the " PHMB Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document," dated January 18, 2005; " Poly( hexamethylenebiguanide) Hydrochloride ( PHMB) Risk Assessment for the Reregistration Eligibility Decision," dated February 14, 2005; and " PHMB  2nd Report of the Hazard Identification Assessment Review Committee," dated April 9, 2003. These documents are available on Agency's website in the EPA Docket at http:// www/ epa. gov/ edockets.

The Agency has reviewed all toxicity studies submitted for PHMB and has determined that the toxicological database is sufficient for reregistration. The studies have been submitted to support guideline requirements. Major features of the toxicology profile are presented below.

Table 1. Summary of Acute Toxicity Data for PHMB Guideline No. Study Type MRID #( s) Results Toxicity Category Acute Toxicity 00030330 LD50 = 2747 mg/ kg 44940701 LD50 = 1831mg/ kg ( M) LD50 = 1617mg/ kg ( F) 870.1100 Acute Oral 45916505 LD50 = 1049mg/ kg ( F) III 00065124 LD50 > 2.0 ml/ kg 44940702 LD50 > 2000mg/ kg III 870.1200 Acute Dermal 45916506 LD50 > 5000mg/ kg IV 870.1300 Acute Inhalation 44970403 LC50 = 1.76mg/ L III 8 Guideline No. Study Type MRID #( s) Results Toxicity Category 45916508 Corrosive I 870.2400 Primary Eye Irritation 00046789 00065120 44963902 Moderate irritant II 00046789 00065120 Moderate irritant II 870.2500 Primary Skin Irritation 44949704 45916509 Slight irritant IV 42674201 Moderate sensitizer 870.2600 Dermal Sensitization 44940705 Mild sensitizer NA Notes: LC = Lethal Concentration; LD = Lethal Dose; NA = Not Applicable The doses and toxicological endpoints selected for various exposure scenarios are summarized in Table 2 below.

Table 2. Dietary Toxicological Endpoints for PHMB Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13 50 years of age) NOAEL = 20 mg/ kg/ day UF = 100 Acute RfD = 0.2 mg/ kg/ day FQPA SF = 1 aPAD = acute RfD FQPA SF = 0.2 mg/ kg/ day Rabbit Developmental Study ( MRID 42865901)

LOAEL = 40 mg/ kg/ day based on reduced number of litters and skeletal abnormalities.

Acute Dietary ( General population including infants and children) No Appropriate single dose effects can be selected for general population Chronic Dietary ( All populations) NOAEL= 20 mg/ kg/ day UF = 100 Chronic RfD = 0.2 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD FQPA SF = 0.2 mg/ kg/ day Rabbit Developmental Study ( MRID 42865901) LOAEL = 40 mg/ kg/ day Based on the increased mortality, reduced food consumption, and clinical toxicity;

Mouse Developmental Study ( Report No. CTL/ P/ 335, 1977 ( cited in Report No. 003810, 1978. Section C 9)) LOAEL = 40 mg/ kg/ day; Based on reduced body weight gain; and Rat Developmental Study ( Report No. CTL/ P/ 1262, 1976 ( cited in Report No. 003810, 1978. Section C 11)) LOAEL = 50 mg/ kg/ day Based on reduced food consumption. 9 Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Cancer ( Oral, dermal, inhalation) The HED Cancer Assessment Review Committee ( CARC) classified PHMB as " Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic Potential" by the oral and dermal routes. Quantification of human cancer risk is not required.

Notes: UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose General Toxicity Observations Dietary The acute RfD is 0.2 mg/ kg/ day for females ( 13 50 years), based on adverse developmental effects ( reduced number of litters and skeletal abnormalities) at 40 mg/ kg/ day in a rabbit developmental study. The chronic RfD is 0.2 mg/ kg/ day based on increased mortality, reduced food consumption, and clinical toxicity at 40 mg/ kg/ day in a rabbit developmental study; reduced body weight gain in a mouse developmental study at 40 mg/ kg/ day; and reduced food consumption in a rat developmental study at 50 mg/ kg/ day. An uncertainty factor of 100 ( 10X for interspecies extrapolation and 10X for intraspecies variability) was applied to the NOAEL to obtain the acute and chronic RfDs.

Incidental Oral The short and intermediate term incidental oral NOAEL is 20 mg/ kg/ day from the rabbit, mouse, and rat developmental toxicity studies that noted increased mortality, reduced food consumption, clinical toxicity, and/ or reduced body weight gain. The target margin of exposure ( MOE) is 100.

Short, Intermediate, and Long term Dermal The short, intermediate, and long term dermal NOAEL is 150 mg/ kg/ day, which is based on decreased body weight and liver tumors identified at a dose of 750 mg/ kg/ day in an 80 week dermal painting study in mice. The uncertainty factor or " target" MOE for PHMB dermal exposures are 100 for occupational and residential scenarios.

Short and Intermediate term Inhalation The short and intermediate term inhalation NOAEL is 20 mg/ kg/ day based on the oral endpoint. In the absence of route specific data, it was conservatively assumed that inhalation absorption is equivalent to oral absorption ( i. e., 100%). For inhalation exposures, the uncertainty factor is 100 for occupational and residential scenarios. An additional 10x route to route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.

Carcinogenicity Classification The Agency classified PHMB as " Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic Potential" by the oral and dermal routes. Quantification of human cancer risk is not required. 10 Mutagenicity Potential The data base for mutagenicity is considered adequate based on EPA's mutagenic guidelines and indicates that PHMB is not mutagenic or genotoxic.

Endocrine Disruption Potential EPA is required under the Federal Food Drug and Cosmetic Act ( FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." When the appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disrupting Screening Program ( EDSP) have been developed, PHMB may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption.

2. FQPA Safety Factor The FQPA Safety Factor ( as required by the Food Quality Protection Act of 1996) is intended to provide an additional 10 fold safety factor ( 10X), to protect for special sensitivity in infants and children to specific pesticide residues in food, drinking water, or residential exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been removed ( i. e., reduced to 1X) for PHMB based on: ( 1) a lack of evidence that PHMB will induce neurotoxic effects, ( 2) no quantitative or qualitative evidence of increased susceptibility to the fetus following in utero exposure in the prenatal developmental toxicity studies, and ( 3) no quantitative or qualitative evidence of increased susceptibility to the offspring when adults are exposed in the two generation reproductive study. The FQPA Safety Factor assumes that the exposure databases ( food, drinking water, and residential) are complete and that the risk assessment does not underestimate the potential risk for infants and children. These criteria have been met for PHMB. Based on the analysis of submitted developmental toxicity studies, the Agency determined that no special FQPA Safety Factor was needed since there were no residual uncertainties for pre and/ or postnatal toxicity.

3. Population Adjusted Dose ( PAD)

Dietary risk is characterized in terms of the Population Adjusted Dose ( PAD), which reflects the reference dose ( RfD), either acute or chronic, that has been adjusted to account for the FQPA Safety Factor ( SF). This calculation is performed for each population subgroup. A risk estimate that is less than 100% of the acute or chronic PAD is not of concern.

a. Acute PAD Acute dietary risk for PHMB is assessed by comparing acute dietary exposure estimates ( in mg/ kg/ day) to the acute Population Adjusted Dose ( aPAD). Acute dietary risk is expressed as a percent of the aPAD. The aPAD is the acute reference dose ( 0.2 mg/ kg/ day) modified by the FQPA safety factor. The acute reference dose was derived from a developmental toxicity study in rabbits in which both the NOAEL ( 20 mg/ kg/ day) and the LOAEL ( 40 mg/ kg/ day) were determined. Acute dietary exposure was estimated only for females ages 13 50 because available studies did not show a toxicity endpoint attributable to a single exposure for the general 11 population. The PHMB aPAD is 0.2 mg/ kg/ day based on a reference dose of 0.2 mg/ kg/ day, and the FQPA safety factor of 1X.

b. Chronic PAD Chronic dietary risk for PHMB is assessed by comparing chronic dietary exposure estimates ( in mg/ kg/ day) to the chronic Population Adjusted Dose ( cPAD). Chronic dietary risk is expressed as a percent of the cPAD. The cPAD is the chronic reference dose ( 0.2 mg/ kg/ day) modified by the FQPA safety factor. The cPAD was derived from developmental studies in rats, rabbits, and mice, in which both the NOAELs ( 20 mg/ kg/ day) and the LOAELs ( 40 mg/ kg/ day in rats and rabbits and 50 mg/ kg/ day in mice) were determined. The PHMB cPAD is 0.2 mg/ kg/ day based on a reference dose of 0.2 mg/ kg/ day, which incorporates the FQPA safety factor ( 1X) for the overall U. S. population or any population subgroups.

4. Exposure Assumptions Acute and chronic dietary exposure assessments from PHMB use as a disinfectant on indirect food contact surfaces were conducted using an equation that considers application rates, surface area, pesticide migration fraction, and body weight. This approach differs from the FDA approach. However, in assessing dietary exposures from PHMB in latex adhesives, a number of assumptions were made based on the FDA guidelines ( FDA, 2003b) for the migration level, consumption factor, total food intake, and amount of packaging required for food. As a conservative assumption, it is assumed that latex adhesive represents 10% of the packaging. Also, it is assumed that paper used in food packaging weighs 50 mg/ in2.

5. Dietary Risk Assessment Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency's risk concerns. A summary of acute and chronic risk estimates are shown in Table 4. Based on a review of product labels containing PHMB, four uses have been identified as having the potential to cause indirect dietary exposure due to indirect food contact: 1. Tunnel Pasteurization 2. Disinfectant on Countertops ( representative of food contact hard surfaces) 3. Latex Adhesives on Food Packaging 4. Disinfectant Cloths Although tunnel pasteurization has the potential for causing indirect dietary exposure to PHMB, an Estimated Daily Intake ( EDI) has not been calculated for this use because the bottles or cans are already sealed, and the possibility of infiltration of this product from tunnel pasteurization water into the food appears to be minimal.

a. Dietary Risk from Food A screening level acute dietary risk assessment was conducted for three of the four PHMB food uses, excluding tunnel pasteurization. Acute dietary risk estimates are provided for females 13 49 years old, the only population subgroup for which an endpoint was selected. The results showed risk estimates to be < 10% of the aPAD for each use site and therefore were not of concern. The chronic dietary assessment concluded that for all included uses, the chronic risk 12 estimates are below the Agency's level of concern for the general U. S. population (< 10% of the cPAD) and all population subgroups (< 40% of the cPAD for children, the most highly exposed subgroup). Because the exposure associated with latex adhesives is several orders of magnitude less than the exposure associated with the countertop disinfectant use, the combined dietary exposure amounts are, for all practical purposes, the same as the exposure to the countertop disinfectant, with the liquid disinfectant as a worst case scenario.

Table 3. Summary of Dietary Exposure and Risk for PHMB Acute Dietary Chronic Dietary Population Subgroup Dietary Exposure ( mg/ kg/ day) a % aPAD b Dietary Exposure ( mg/ kg/ day) a % cPAD b Liquid Disinfectant Adult Male 0.016  0.016 8 Adult Female 0.018 9 0.018 9 Child 0.074  0.074 37 Wipe Disinfectant Adult Male 0.0045  0.0045 2 Adult Female 0.0053 3 0.0053 3 Child 0.021  0.021 11 Latex Adhesive Adult Male 7.4x10 10  7.4x10 10 5.69x10 7 Adult Female 8.6x10 10 4.3x10 7 8.6x10 10 6.62x10 7 Child 3.4x10 10  3.4x10 10 2.62x10 6 a acute and chronic exposure analysis based on daily consumption associated with use of a liquid disinfectant on counter tops and exposure to food packages using treated latex adhesive. b % PAD = dietary exposure ( mg/ kg/ day) / aPAD or cPAD, where aPAD= 0.2 mg/ kg/ day ( for adult females only) and cPAD= 0.2 mg/ kg/ day ( for all populations)

b. Dietary Risk from Drinking Water None of the uses associated with PHMB are expected to impact either surface or ground water resources. Therefore, no drinking water assessment was performed.

6. Residential Risk Assessment a. Residential Toxicity The toxicological endpoints and associated uncertainty factors used for assessing the nondietary residential risks for PHMB are listed in Table 4. 13 Table 4. Residential Toxicological Endpoints for PHMB Exposure Scenario Dose Used in Risk Assessment, UF Level of Concern for Risk Assessment Study and Toxicological Effects Short Term Incidental Oral ( 1 30 days) NOAEL= 20 mg/ kg/ day UF = 100 Residential LOC for MOE = 100 Occupational = NA Rabbit Developmental Study ( MRID 42865901) LOAEL = 40 mg/ kg/ day Based on the increased mortality, reduced food consumption, and clinical toxicity;

Mouse Developmental Study ( Report No. CTL/ P/ 335, 1977 ( cited in Report No. 003810, 1978. Section C 9)) LOAEL = 40 mg/ kg/ day; Based on reduced body weight gain; and Rat Developmental Study ( Report No. CTL/ P/ 1262, 1976 ( cited in Report No. 003810, 1978. Section C 11)) LOAEL = 50 mg/ kg/ day Based on reduced food consumption.

Intermediate Term Incidental Oral ( 1 6 months) NOAEL= 20 mg/ kg/ day UF = 100 Residential LOC for MOE = 100 Occupational = NA See Short Term Incidental Oral Endpoint Short Term, Intermediate Term, and Long Term Dermal Exposure Dermal ( or oral) study NOAEL= 150 mg/ kg/ day UF = 100 Residential LOC for MOE = 100 Occupational LOC for MOE = 100 80 Week Dermal Painting Study ( MRIDs 00066475 and 00104796) LOAEL = 750 mg/ kg/ day based on decreased body weight and liver tumors.

Short Term and Intermediate Term Inhalation Exposure No appropriate route specific study was available. The oral endpoint of 20 mg/ kg with a Margin of Exposure of 100 ( 10x inter species extrapolation, 10x intra species variation) is used. An additional 10x route to route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.

Cancer ( Oral, dermal, inhalation) The HED Cancer Assessment Review Committee ( CARC) classified PHMB as " Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic Potential" by the oral and dermal routes. Quantification of human cancer risk is not required.

Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, LOC = level of concern, MOE = margin of exposure b. Residential Handlers i. Exposure Assessment Based on the use patterns of PHMB, EPA has identified the four major exposure scenarios for residential handlers including: ° Open pouring for swimming pools/ spas; ° Spraying ( aerosol and/ or trigger pump sprays) disinfectants; ° Mopping with disinfectants; and 14 ° Wiping with disinfectants.

Using surrogate unit exposure data from the Pesticide Handlers Exposure Database ( PHED) and the Chemical Manufacturers Association ( CMA) database, maximum application rates from labels, and EPA estimates of daily amount handled, exposure to residential handlers were assessed. PHMB is assessed using a typical residential swimming pool capacity of 20,000 gallons. For mopping, it is assumed that a 1 gallon bucket of solution is used by a homeowner to mop the floor.

ii. Risk Assessment All of the inhalation and dermal MOEs for residential handlers are above the target MOE of 100 and, therefore, not of concern. In addition, the inhalation MOEs for each use are above the MOE of 1,000, when the additional route to route extrapolation uncertainty factor is applied. An inhalation study is not being required for the residential uses at this time. The MOEs for handlers are summarized in Tables 5.

Table 5. Residential Handler Risk Summary Exposure Scenario Use site Label Application Rate ( lb a. i./ day) Baseline Dermal MOE Baseline Inhalation MOE Open Pouring Residential Pool 2.2 35,000 180,000 Spraying Household Premises ( hard surfaces) 0.006 8,000 180,000 Mopping Household Floors ( hard surfaces) 0.023 6,400 26,000 Wiping Household Premises ( hard surfaces) 0.006 610 3,400 c. Residential Post Application i. Exposure Assessment Based on the use patterns, EPA has identified residential post application exposure scenarios for the swimming pool/ spa use along with the hard surface cleaners. The exposure scenarios ( and assumptions used in the assessment) that are considered representative of the high end exposures associated with PHMB include:

° Dermal exposure and ingestion of PHMB via swimming in treated pools for adults and children, both competitive and non competitive. The SWIMODEL 3.0 default values and chemical specific values ( MRIDs 44051301 and 44046301) were used in the calculations for the assessment. Exposure time for non competitive swimmers is based on data provided in EPA's Exposure Factors Handbook ( 1997) whereas competitive swimmer exposure time data are based on the Agency's review of the American Chemistry Council ( ACC) study " An Analysis of the Training Patterns and Practices of Competitive Swimmers" ( ACC, 2002).

° Dermal contact and incidental ingestion ( i. e., hand to mouth residue transfer) resulting 15 from toddlers crawling on treated floors after mopping. While other hard surfaces may be treated ( e. g., wiping counter tops/ sinks), it is believed that the floor represents the high end exposure scenario for children's contact. Residential SOP assumptions are used for this assessment. Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). A body surface area of 0.657 m2 has been assumed, which is the median value. It was also assumed that the diluted treatment solution is applied at a rate of 1000 sq. ft. per gallon, as this was not provided on the label. As a conservative measure, it has been assumed that 25% of the mop solution remains after the final mop. The Residential SOPs estimate of 10% of the amount on the floor/ hard surface available for dermal transfer is used.

ii. Risk Assessment The residential post application risk assessment identifies short term ( 1 30 days) and intermediate term ( 1 6 month) exposure doses based on the reported toxicology endpoints for PHMB. Because of the shorter exposure durations of these toxicological endpoints, conservative event based exposure assumptions are used to calculate upper bound daily dose estimates. Doses are not amortized over a lifetime. Additionally, since the permeability constant provides estimates of an internal dose from the dermal route of exposure, the oral toxicity endpoint rather than the dermal toxicity endpoint is used to assess the risks from the dermal swimming route.

Table 6 presents the estimated doses from the dermal and ingestion routes of exposure and the corresponding MOEs based on the oral endpoint for the swimming scenarios for each age group. The calculated results for short, intermediate, and long term exposures and risks indicate that the risks from the dermal and ingestion routes of exposure are not of concern ( MOE> 100) for the post application scenarios developed in this assessment.

Table 6. Residential Post Application Risk Summary Use Type Scenario Description Dermal Dose ( mg/ kg/ day) Incidental Ingestion Dose ( mg/ kg/ day) Dermal MOEa Inhalation MOEa Adult Competitive 4.06E 5 0.0056 490,000 3600 Adult Non Competitive 6.76E 5 0.019 300,000 1100 Child ( 7 10 yrs) Competitive 1.80E 5 0.017 1,100,000 1200 Child ( 7 10 yrs) Non Competitive 9.01E 5 0.087 220,000 230 Child ( 11 14 yrs) Competitive 3.08E 5 0.011 650,000 1800 Swimming Pool Child ( 11 14 yrs) Non Competitive 4.62E 5 0.033 430,000 620 Floors Child, Short Term Duration 150 0.031 600 660 Floors Child, Intermediate Term Duration 150 0.014 600 1,400 aMOE = NOAEL ( mg/ kg/ day)/ Dose ( mg/ kg/ day). The same oral NOAEL is used for dermal and ingestion risks. Target MOE = 100; NA = Not Applicable 16 7. Aggregate Risk The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act ( FFDCA, Section 408( b)( 2)( A)( ii)) require " that there is a reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information." Aggregate exposure will typically include exposures from food, drinking water, residential uses of a pesticide, and other non occupational sources of exposure.

In the case of PHMB, a cancer aggregate assessment is not needed, as the chemical has been classified by the Agency's Cancer Assessment Review Committee as having " Suggestive Evidence of Carcinogenicity, but Not Sufficient to Assess Human Carcinogenic Potential." For the non cancer aggregate assessment, there is no need for an acute and chronic dietary aggregate assessment, as the uses of PHMB have been determined to have no impact on surface or ground water and the dietary risk calculations estimated will characterize the total dietary risk of PHMB. In the case of short, intermediate, and long term aggregate assessments, the following exposure scenarios were aggregated for adults exposed to PHMB: dietary exposure, dermal and inhalation exposure from liquid pouring of PHMB swimming pool product, and dermal and incidental oral exposure from swimming. Aggregate exposures for children and toddlers included food exposure and dermal and incidental oral exposure from swimming. Cleaning activities were not included in the aggregate assessment as these activities were not felt to reasonably occur together with the other exposure scenarios. As about 95% of PHMB is used in swimming pool products, it is unlikely that residential users will be using PHMB both to sanitize their swimming pools and clean their homes.

a. Short and Intermediate Term Aggregate Risk The Agency has concluded that, although an oral toxicity study was selected for dietary, inhalation, and incidental oral risk assessments and a dermal toxicity study was selected for dermal risk assessments, the non cancer effects occurring by the oral and dermal routes were similar and that these exposures should be aggregated. The report describing this decision can be found in OPP 2004 0305 at http:// www. epa. gov/ edockets. Inhalation exposures are currently included in the aggregate assessment based on the use of the oral endpoint. Aggregate MOE calculations for adults and children were performed using the Aggregate Risk Index method ( USEPA, 2001a). As shown in Table 7, no aggregate risks of concern were identified for either adults or children. 17 Table 7. Short and Intermediate Term Aggregate Risks Population Subgroup Chronic Food Exp mg/ kg/ day/

( MOE) ST/ IT Incidental Oral Swimming Exposure ( mg/ kg/ day)

( MOE) ST/ IT Dermal Swimming Exposure ( mg/ kg/ day)

( MOE) Liquid Pouring Dermal Exposure ( mg/ kg/ day)

( MOE) Liquid Pouring Inhalation Exposure ( mg/ kg/ day)

( MOE) Aggregate Risk Index 0.0056 ( comp.)

( 3600) 0.000044 ( comp.)

( 450000) 9.0 Males 0.016/

( 1250) 0.019 ( non comp.)

( 1100) 0.000015 ( non comp.)

( 1,300000) 0.00424 ( 35,000) 0.000113 ( 180,000) 5.7 0.0056 ( comp.)

( 3600) 0.000044 ( comp.)

( 450000) 8.2 Females 13

50 years 0.018/

( 1111) 0.019 ( non comp.)

( 1100) 0.000015 ( non comp.)

( 1,300000) 0.00491 ( 31,000) 0.000131 ( 153,000) 5.4 0.017 ( comp.)

( 1200) 0.000018 ( comp.)

( 1,100,000) 2.2 Children 7

10 years 0.074/

( 270) 0.087 ( non comp.)

( 230) 0.00009 ( non comp.)

( 220000) N/ A N/ A 1.2 0.011 ( comp.)

( 1800) 0.00003 ( comp.)

( 650000) 2.3 Children 11

14 years 0.074 ( 270) 0.033 ( non comp.)

( 620) 0.000046 ( non comp.)

( 430000) N/ A N/ A 1.9 MOE = NOEL ( mg/ kg/ day)/ Dose( mg/ kg/ day). Oral NOAEL is 20 mg/ kg/ day for short and intermediate term. Dermal NOAEL is 150 mg/ kg/ day for short and intermediateterm Inhalation NOAEL is 20 mg/ kg/ day for short term. The target Margins of Exposure for all exposures are 100.

Aggregation was performed using the Aggregate Risk Index method. ARI = 1/ (( UF1/ MOE1) + ( UF2/ MOE2) + ( UF3/ MOE3) +  ). ARIs greater than 1 are not of concern. 18 b. Chronic Aggregate Risk A long term aggregate risk assessment was not performed in this assessment. None of the residential exposure scenarios are considered to be long term and were, therefore, not aggregated with the chronic dietary exposure.

8. Occupational Risk Workers can be exposed to a pesticide through mixing, loading, and/ or applying a pesticide, or re entering treated sites ( post application exposure). Occupational handlers of PHMB include workers pouring or pumping PHMB preservatives into vats or tanks for several uses ( materials preservatives, tunnel pasteurization, and industrial processes and water systems); pouring PHMB products into swimming pools and spas; and spraying, wiping, and moping PHMB disinfectants on medical premises and equipment. Occupational risk for all of these potentially exposed populations is measured by a Margin of Exposure ( MOE) which determines how close the occupational exposure comes to a No Observed Adverse Effect Level ( NOAEL) from toxicological studies. In the case of PHMB, MOEs greater than 100 are not of concern to the Agency. This MOE includes the standard safety factors of 10X for intraspecies variability ( i. e. differences among humans) and 10X for interspecies variability ( differences between humans and animals). An additional 10x route to route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted. At this time, EPA does not foresee postapplication exposures for the occupational uses of PHMB.

Occupational risk is assessed for exposure at the time of application ( termed " handler" exposure). Application parameters are generally defined by the physical nature of the formulation ( e. g., formula and packaging), by the equipment required to deliver the chemical to the use site, and by the application rate required to achieve an efficacious dose. Occupational risks were assessed for exposures from pouring liquid formulations, as well as spraying, wiping, and mopping applications.

For more information on the assumptions and calculations of potential risk of PHMB to workers, see the Occupational Exposure Assessment ( Section 7.0) in the " Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Risk Assessment for the Reregistration Eligibility Decision," dated February 14, 2005 and the " PHMB Occupational/ Residential Exposure Assessment," dated February 3, 2005. 19 a. Occupational Toxicity The toxicological endpoints used in the assessment can be found in Table 8 below.

Table 8. Occupational Toxicological Endpoints for PHMB Exposure Scenario Dose Used in Risk Assessment, UF Level of Concern for Risk Assessment Study and Toxicological Effects Short Term, Intermediate Term, and Long Term Dermal Exposure Dermal ( or oral) study NOAEL= 150 mg/ kg/ day UF = 100 Residential LOC for MOE = 100 Occupational LOC for MOE = 100 80 Week Dermal Painting Study ( MRIDs 00066475 and 00104796) LOAEL = 750 mg/ kg/ day based on decreased body weight and liver tumors.

Short Term and Intermediate Term Inhalation Exposure No appropriate route specific study was available. The oral endpoint of 20 mg/ kg with a Margin of Exposure of 100 ( 10x inter species extrapolation, 10x intra species variation) is used. An additional 10x route to route extrapolation is used to determine if a confirmatory inhalation toxicity study is warranted.

Cancer ( Oral, dermal, inhalation) The HED Cancer Assessment Review Committee ( CARC) classified PHMB as " Suggestive Evidence of Carcinogenicity, but not sufficient to Assess Human Carcinogenic Potential" by the oral and dermal routes. Quantification of human cancer risk is not required.

Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, LOC = level of concern, MOE = margin of exposure b. Occupational Handler Exposure Inhalation and dermal exposures to PHMB were addressed for occupational populations using surrogate data from the Pesticide Handlers Exposure Database ( PHED) ( USEPA, 1997c), the Chemical Manufacturers Association ( MRID 42587501), and several studies which relate to the use patterns of PHMB. Using surrogate dermal and inhalation unit exposure data, application rates from labels, and EPA estimates of daily amount handled, exposure and risks to handlers were assessed. A description of the surrogate data and calculations used are included in the Occupational Exposure Assessment ( Section 7.0) in the " Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Risk Assessment for the Reregistration Eligibility Decision," dated February 14, 2005 and the " PHMB Occupational/ Residential Exposure Assessment," dated February 3, 2005.

The Agency has determined that there are potential exposures to individuals who mix, load, apply, and otherwise handle PHMB during the usual use patterns associated with the pesticide's use. Based on the use patterns, the exposure scenarios in Table 9 were assessed. 20 Table 9. PHMB Handler Scenarios Category Scenario Material Preservatives Pouring PHMB industrial preservative into vats or tanks of slurry containing leather processing fluids, silicones, adhesives, mineral slurries, textiles, etc.

Food Handling/ Storage Establishments Premises and Equipment Pouring PHMB preservative into vats or tanks for tunnel pasteurization.

Industrial Processes and Water Systems Pouring or pumping PHMB preservative into vats or tanks for preservation of oil well injection fluids, mud packer solutions, and workover solutions.

Swimming Pools Pouring PHMB preservatives into pools or spas by commercial treaters.

Medical Premises and Equipment PHMB is used in a spray, wipe and mop to sterilize surfaces as a hospital cleaner disinfectant and medical equipment. Disinfectants are applied by spray, mopping and wiping.

c. Occupational Handler Risk Summary The occupational handler risk assessment included both inhalation and dermal exposures. The target MOE for both is 100. Scenarios with an MOE less than 100 indicate a risk of concern. After performing the exposure assessment, EPA determined that the greatest potential for exposure appears to be the inhalation and dermal occupational scenarios involving pour liquid for drilling muds and workover fluids, based on application rates of 1,052 lbs. of active ingredient per day ( dermal MOE = 74 and inhalation MOE = 370, target MOEs of 100). In order to achieve MOEs above the target level ( i. e., greater than 100), scenarios involving drilling muds and workover fluids must use mitigation measures such as metering pump systems. Calculated MOEs using the pump liquid scenario ( i. e., dermal MOE= 1,600 and inhalation MOE 3,300) are greater than the target MOE. As the mitigation measure brings the inhalation MOE above 1,000 ( which includes the additional 10x route to route extrapolation), no confirmatory inhalation toxicity study is needed.

Dermal and inhalation MOEs for the commercial exposure scenarios involving commercial pool operators pouring PHMB liquid into multiple residential swimming pools and spas are greater than the target MOE and, therefore, are not of concern. The commercial handlers for the medical premises uses did not trigger risks of concern for the spray/ mop/ wipe applications.

9. Human Incident Data In evaluating incidents to humans, the Agency reviewed reports from the National Poison Control Centers ( PCC), the Agency's Office of Pesticide Program's Incident Data System ( IDS), California Department of Pesticide Regulation, and the National Pesticide Telecommunications Network ( NPTN). Incident reports were only found in IDS and PCC. Those found in PCC were also in IDS. Therefore, all incidents are reported as found in IDS.

A total of 118 individual incident cases submitted to the EPA Office of Pesticide Programs involving use of PHMB containing swimming pool products were reviewed to determine the effects of exposure to PHMB. All of the incident reports reviewed were for residential use of the products by consumers. In 17 ( 14%) out of the 118 individual incident 21 cases reviewed, it was determined that the exposure effects were the result of not using the product as intended by the manufacturer. They included not following the instructions on the label, accidental ingestion of the product, or splashing the concentrated product onto the skin or into the eyes.

The reported routes for exposure of the 118 incident cases were dermal ( 58%), ocular ( 30%), ingestion ( 9%), inhalation ( 7%), and unknown (< 1%). In some cases more than one route of exposure applied for an individual incident case ( e. g., both dermal and ocular exposure). The most common symptoms reported for each exposure route are as follows: ° Dermal exposure: skin irritation/ burning, rash, hives/ welts, itching, skin discoloration/ redness, allergic reaction, and blistering ° Ocular exposure: eye irritation/ burning, eye pain, loss of vision, swelling of eyes, and allergic reactions. ° Ingestion/ oral exposure: vomiting/ nausea/ abdominal pain, irritation to the mouth/ throat, respiratory irritation including coughing/ choking, and diarrhea ° Inhalation exposure: respiratory irritation and coughing/ choking B. Environmental Risk Assessment A summary of the Agency's environmental risk assessment is presented below. PHMB has several registered use sites: swimming pools, cut flowers, materials preservatives, industrial processes and water systems, and hard surfaces. The following risk characterization is intended to describe the magnitude of the estimated environmental risks for PHMB use sites and any associated uncertainties.

For detailed discussions of all aspects of the environmental risk assessment, see the Environmental Risk Assessment ( Section 8.0) in the " Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Risk Assessment for the Reregistration Eligibility Decision," dated February 14, 2005, the " Environmental Fate Assessment of PHMB for the Reregistration Eligibility Decision ( RED)," dated August 18, 2004, and the " Ecological Hazard and Environmental Risk Assessment: Poly( hexamethlenebiguanide) hydrochloride ( PHMB)," dated August 4, 2004.

1. Environmental Fate and Transport PHMB is stable hydrolytically in the environment and has a half life of more than thirty days. This may be of environmental concern for surface water contamination, in the event of exposure to surface water. Studies for other fate processes are not required by and have not been submitted to the Agency.

2. Ecological Risk The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity studies to estimated environmental concentrations based on environmental fate characteristics and pesticide use data. 22 a. Toxicity ( Hazard) Assessment PHMB demonstrates low toxicity to birds and mammals and high toxicity to freshwater aquatic organisms. All submitted ecological toxicity studies were conducted with a 20% a. i. solution of PHMB, which is the technical formulation, and values were adjusted to 100% a. i. to classify the studies according to relative toxicity. Submission of data regarding toxicity to marine/ estuarine organisms, plants, or chronic effects was not required for the indoor uses of PHMB. Limited additional data was found using EPA's ECOTOX database. A summary of submitted data is provided in the table below.

Table 10. Summary of Submitted Acute Ecological Effects Toxicity Data for PHMB Species LD50/ LC50 NOAEL/ NOAEC Toxicity category ( based on 100% AI)

Birds Northern bobwhite ( Colinus virginianus) LC50 > 5620 (> 1124 ppm ai) NOEC 5620 ppm ( 1124 ppm ai) Slightly toxic Mallard duck ( Anas platyrhynchos) LC50 > 5620 (> 1124 ppm ai) NOEC 5620 ( 1124 ppm ai) Slightly toxic Mallard ( Anas platyrhynchos) LD50 > 2510 (> 502 mg ai/ kg) NOEL = 2510 ( 502 mg ai/ kg) Slightly toxic Mammals Laboratory rat ( Rattus norvegicus) LD50 = 2747 mg/ kg N/ A Freshwater Fish Rainbow trout ( Oncorhynchus mykiss) 96 hr. LC50 = 0.02545 ppm ai NOEC = 0.0098 ppm ai Very highly toxic Bluegill sunfish ( Lepomis macrochirus) 96 hr. LC50 = 0.57 ( 0.114 ppm ai); NOEC = 0.17 ( 0.034 ppm ai) Highly toxic Freshwater Invertebrate Waterflea ( Daphnia magna) 48 hr. EC50 = 0.18( 0.12  0.30) ( 0.036 ppm ai) NOEC = 0.7 ( 0.14 ppm ai) Highly toxic N/ A = not available NOAEC= No observable adverse effect concentration b. Exposure and Risk Environmental exposure modeling was not conducted for PHMB. The only use pattern likely to result in significant outdoor exposure is the oil recovery use; however, there is a label statement prohibiting use over or near marine/ estuarine ( e. g., offshore) oil fields. The uses of 23 PHMB considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur. Facilities using PHMB for indoor industrial applications are required to have NPDES permits before discharging effluents into receiving waters.

c. Risk to Listed Species Due to the low likelihood of exposure and low toxicity of PHMB, the Agency expects no effects to listed species or critical habitat and, therefore, makes a " No Effect" determination for this chemical. 24 IV. Risk Management, Reregistration, and Tolerance Reassessment Decision A. Determination of Reregistration Eligibility Section 4( g)( 2)( A) of FIFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient, whether or not products containing the active ingredient are eligible for reregistration. The Agency has previously identified and required the submission of the generic ( i. e., active ingredient specific) data required to support reregistration of products containing PHMB as an active ingredient. The Agency has completed its review of these generic data and has determined that the data are sufficient to support reregistration of all supported products containing PHMB.

The Agency has completed its assessment of the dietary, occupational, drinking water, and ecological risks associated with the use of pesticide products containing the active ingredient PHMB. Based on a review of these data and on public comments on the Agency's assessments for the active ingredient PHMB, the Agency has sufficient information on the human health and ecological effects of PHMB to make decisions as part of the tolerance reassessment process under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency has determined that PHMB containing products are eligible for reregistration provided that: ( i) current data gaps and confirmatory data needs are addressed; ( ii) the risk mitigation measure outlined in this document is adopted; and ( iii) label amendments are made to reflect this measure. Label changes are described in Section V. Appendix A summarizes the uses of PHMB that are eligible for reregistration. Appendix B identifies the generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of PHMB and lists the submitted studies that the Agency found acceptable. Data gaps are identified as generic data requirements that have not been satisfied with acceptable data.

Based on its evaluation of PHMB, the Agency has determined that PHMB products, unless labeled and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measure identified in this document, the Agency may take regulatory action to address the risk concerns from the use of PHMB. If all changes outlined in this document are incorporated into the product labels, then all current risks for PHMB will be substantially mitigated for the purposes of this determination.

B. Public Comments and Responses Through the Agency's public participation process, EPA worked with stakeholders and the public to reach the regulatory decision for PHMB. During the public comment period on the risk assessments, which closed on September 27, 2004, the Agency received numerous comments that addressed human health and ecological concerns from one of the technical registrants ( Arch Chemicals, Inc.); state and local regulatory agencies ( California Regional Water Quality Control Board and San Francisco Department of the Environment); an environmental group ( Natural Resources Defense Council [ NRDC]); water advocacy groups ( Sanitation Districts of Los Angeles County and California Stormwater Quality Association); and one private citizen. Comments were received on the following topics: 25 ° Toxicology and Mode of Action of PHMB and Endpoints Chosen; ° Ecological Risks of PHMB; ° Exposure to PHMB; ° Occupational and Residential Exposure to and Risk from PHMB; ° Dietary Exposure and Risk Assessment; ° Efficacy of PHMB as a Swimming Pool Sanitizer; and ° Abbreviated Length of Public Comment Period.

These comments have been addressed and the assessments refined, as appropriate, by the Agency. Response to Comments documents addressing these comments, and those received by the registrants during Phase I of the RED process, are available in the public docket at http:// www. epa. gov/ edockets ( OPP 2004 0305).

Comments that were received comments from the California Regional Water Quality Control Board, San Francisco Department of the Environment, Sanitation Districts of Los Angeles County, and California Stormwater Quality Association on the possible release of PHMB to surface waters are being addressed in the RED as follows:

Comment: Two governmental and two advocacy groups submitted comments in late September 2004 stating the following ( exact language differed slightly among comments): Despite uses that will inevitably discharge PHMB to surface waters, the U. S. EPA re registration risk assessment does not estimate surface water concentrations. U. S. EPA incorrectly assumes that environmental exposure to PHMB will not occur. Whether discharged to a storm drain or a wastewater treatment plant, PHMB will flow to surface water. It provides no chronic toxicity data for aquatic organisms and presents no estimates of PHMB's environmental fate. The risk assessment provides no scientific basis for evaluating PHMB risks to aquatic organisms. These risks must be assessed prior to reregistration.

Response: For certain use categories, such as indoor sanitizers or contained outdoor uses, such as swimming pools, the environmental exposure will be limited in most cases, due either to treatment of wastewaters discharged through municipal sewers and/ or Federal or Local restrictions on how wastewaters are to be handled. For such uses, environmental modeling is not currently performed, and only a minimal toxicity data set is required ( Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, 1/ 23/ 04, Appendix A, Section IIB, pg. 81). Chemicals in these categories, therefore, do not currently undergo a full screening level risk assessment and are considered to fall under a " no effect" determination. The indoor uses of PHMB, as well as the swimming pool use, fall into this category.

While unauthorized discharges into storm sewers, into surrounding waters, or onto the ground could occur, this would be considered a misuse of the pesticide. Illegal uses, or " misuses," of pesticides are not considered in Office of Pesticide 26 Program risk assessments; the assessments are based on the correct, labeled use of the pesticide products. In addition, AD recognizes the possibility of some of these pesticides entering into US waterways, which may pose exposure and hazard concerns. We are in the process of developing and validating various modeling programs, which will help us to ascertain that pesticides entering into U. S. water ways, as well as into the municipal waste treatment plants, are not at levels of concern.

As stated in the 40CFR § 158, the Agency requires a standard set of environmental fate and aquatic toxicity studies to be submitted for indoor uses, including hydrolysis, acute avian oral toxicity, acute freshwater fish toxicity, and acute freshwater invertebrate toxicity. These data requirements have been fulfilled for PHMB, and the database is considered adequate for the purposes of this risk assessment.

Due to the abbreviated nature of the comment period held on the risk assessments in 2004, the Agency is providing a 60 day public comment period on this RED. While all comments are welcome, those with specific data or information bearing on the risk assessments are most useful.

C. Regulatory Position 1. Food Quality Protection Act Findings a. " Risk Cup" Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with PHMB. The Agency has concluded that the risk from dietary exposure is within the " risk cup." An aggregate assessment was conducted for exposures through food and residential uses. Dietary exposure from drinking water was not assessed, as the uses of PHMB have been determined to have no impact on surface or ground water. The Agency has determined that the human health risks from these combined exposures are within acceptable levels. In reaching this determination, EPA has considered the available information on the special sensitivity of infants and children, as well as aggregate exposure from food and residential uses.

b. Determination of Safety to U. S. Population As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with PHMB. The Agency has determined that food uses of PHMB, meet the safety standards under the FQPA amendments to section 408( b)( 2)( D) of the FFDCA, and that there is a reasonable certainty no harm will result to the general population or any subgroup from the use of PHMB. In reaching this conclusion, the Agency has considered all available information on the toxicity, use practices and exposure scenarios, and the environmental behavior of PHMB.

Dietary risk assessments were conducted for adults and children, with the highest risk ( 9% aPAD for adult females and 37% cPAD for children) being below the Agency's level of concern. Aggregate assessments from dietary and residential exposures were also conducted. 27 The Aggregate Risk Index was 1.2 for children ages 7 10 years, the subpopulation with the greatest risk, which is above the Agency's level of concern ( ARI  1).

c. Determination of Safety to Infants and Children EPA has determined that the currently registered uses of PHMB, with changes as specified in this document, meet the safety standards under the FQPA amendments to section 408( b)( 2)( C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers factors of the toxicity, use practices, and environmental behavior noted above for the general population, but also takes into account the possibility of increased susceptibility to the toxic effects of PHMB residues in this population subgroup.

No Special FQPA Safety Factor is necessary to protect the safety of infants and children. In determining whether or not infants and children are particularly susceptible to toxic effects from PHMB residues, the Agency considered the completeness of the database for developmental and reproductive effects, the nature of the effects observed, and other information. The FQPA Safety Factor has been removed ( i. e., reduced to 1X) for PHMB based on: ( 1) there is no concern for developmental neurotoxicity resulting from exposure to PHMB because there is no evidence PHMB will induce neurotoxic effects; ( 2) there is no quantitative or qualitative evidence of increased susceptibility to the fetus following in utero exposure in the prenatal developmental toxicity studies or to the offspring when adults are exposed in the twogeneration reproductive study; and ( 3) the risk assessment does not underestimate the potential exposure for infants and children.

d. Endocrine Disruptor Effects EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

When the appropriate screening and/ or testing protocols being considered under the EDSP have been developed, PHMB may be subject to additional screening and/ or testing to better characterize effects related to endocrine disruption. 28 e. Cumulative Risks Risks summarized in this document are those that result only from the use of PHMB. The Food Quality Protection Act ( FQPA) requires that the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common toxic mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for PHMB. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

2. Tolerance Summary There are no tolerances or exemptions from the requirement of a tolerance established for residues of PHMB.

D. Regulatory Rationale The Agency has determined that PHMB is eligible for reregistration provided that additional required data confirm this decision, the risk mitigation measure outlined in this document are adopted, and label amendments are made to reflect this measure.

The following is a summary of the rationale for managing risks associated with the use of PHMB. Where labeling revisions are warranted, specific language is set forth in the summary tables of Section V of this document.

1. Human Health Risk Management a. Dietary ( Food) Risk Mitigation The acute and chronic dietary risks from PHMB residues on food, estimated using conservative measures, are below the Agency's level of concern. Therefore, no mitigation measures are necessary at this time.

b. Drinking Water Risk Mitigation As none of the uses associated with PHMB are expected to impact either surface or ground water resources, no drinking water mitigation measures are necessary at this time. 29 c. Residential Risk Mitigation i. Handler Risk Mitigation Residential handler risks were considered for pouring PHMB into a single swimming pool, spraying an all purpose cleaner, mopping floors with an all purpose cleaner, and wiping hard surfaces with an all purpose cleaner. No mitigation measures are needed at this time for these uses, as none present a risk of concern.

ii. Post Application Risk Mitigation High end exposures were assessed for residential exposure after application of PHMB products in swimming pools and spas, as well as on hard surfaces. All risks were below the Agency's level of concern, and no mitigation measures are presently required.

d. Occupational Risk Mitigation i. Handler Risk Mitigation EPA determined that the greatest potential for exposure appears to be the inhalation and dermal occupational scenarios involving pour liquid for drilling muds and workover fluids. Using an open pour scenario, these risks are of concern to the Agency. In order for risks to drop below the Agency's level of concern, scenarios involving drilling muds and workover fluids must use mitigation measures such as metering pump systems.

ii. Post Application Risk Mitigation At this time, EPA does not foresee post application exposures for the occupational uses of PHMB; therefore, no mitigation measures are necessary.

2. Environmental Risk Management As the Agency considers the uses of PHMB assessed in this RED to be unlikely to result in any appreciable exposure to terrestrial or aquatic organisms, no environmental risk mitigation is required.

3. Other Labeling Requirements In order to be eligible for reregistration, various use and safety information will be included in the labeling of all end use products containing PHMB. For the specific labeling statements and a list of outstanding data, refer to Section V of this RED document.

4. Listed Species Considerations a. The Endangered Species Act Section 7 of the Endangered Species Act, 16 U. S. C. Section 1536( a)( 2), requires all federal agencies to consult with the National Marine Fisheries Service ( NMFS) for marine and 30 anadromous listed species, or the United States Fish and Wildlife Services ( FWS) for listed wildlife and freshwater organisms, if they are proposing an " action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means " to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C. F. R. § 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection ( a)( 2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species ( U. S. EPA 2004). After the Agency's screening level risk assessment is performed, if any of the Agency's Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co occur in the area of the proposed pesticide use. If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken. The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required ( Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, 1/ 23/ 04, Appendix A, Section IIB, pg. 81). Chemicals in these categories therefore do not undergo a full screening level risk assessment, and are considered to fall under a " no effect" determination. Due to the low likelihood of exposure and low toxicity of PHMB, the Agency expects no effects to listed species or critical habitat and therefore makes a " No Effect" determination for this chemical.

b. General Risk Mitigation PHMB end use products ( EPs) may also contain other registered pesticides. Although the Agency is not proposing any mitigation measures for products containing PHMB specific to federally listed species, the Agency needs to address potential risks from other end use products. Therefore, the Agency requires that users adopt all listed species risk mitigation measures for all active ingredients in the product. If a product contains multiple active ingredients with conflicting listed species risk mitigation measures, the more stringent measure( s) should be adopted. 31 V. What Registrants Need to Do The Agency has determined that PHMB is eligible for reregistration provided that: ( i) additional data that the Agency intends to require confirm this decision; ( ii) the risk mitigation measure outlined in this document is adopted; and ( iii) label amendments are made to reflect this measure. To implement the risk mitigation measure, the registrants must amend their product labeling to incorporate the label statement set forth in the Label Changes Summary Table in Section B below ( Table 13). The additional data requirements that the Agency intends to obtain will include, among other things, submission of the following:

For PHMB technical grade active ingredient products, the registrant needs to submit the following items:

Within 90 days from receipt of the generic data call in ( DCI):

1. completed response forms to the generic DCI ( i. e., DCI response form and requirements status and registrant's response form); and 2. submit any time extension and/ or waiver requests with a full written justification.

Within the time limit specified in the generic DCI:

1. cite any existing generic data which address data requirements or submit new generic data responding to the DCI.

Please contact Jennifer Slotnick at ( 703) 305 0601 with questions regarding generic reregistration.

By US mail: By express or courier service: Document Processing Desk ( DCI/ SRRD) Document Processing Desk ( DCI/ SRRD) Jennifer Slotnick Jennifer Slotnick US EPA ( 7510C) Office of Pesticide Programs ( 7510C) 1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2 Washington, DC 20460 1801 S. Bell Street Arlington, VA 22202 32 For end use products containing the active ingredient PHMB, the registrant needs to submit the following items for each product.

Within 90 days from the receipt of the product specific data call in ( PDCI):

1. completed response forms to the PDCI ( i. e., PDCI response form and requirements status and registrant's response form); and 2. submit any time extension or waiver requests with a full written justification.

Within eight months from the receipt of the PDCI:

1. two copies of the confidential statement of formula ( EPA Form 8570 4);

2. a completed original application for reregistration ( EPA Form 8570 1). Indicate on the form that it is an " application for reregistration";

3. five copies of the draft label incorporating all label amendments outlined in Table 23 of this document;

4. a completed form certifying compliance with data compensation requirements ( EPA Form 8570 34);

5. if applicable, a completed form certifying compliance with cost share offer requirements ( EPA Form 8570 32); and 6. the product specific data responding to the PDCI.

Please contact Adam Heyward at ( 703) 308 6422 with questions regarding product reregistration and/ or the PDCI. All materials submitted in response to the PDCI should be addressed as follows:

By US mail: By express or courier service: Document Processing Desk ( PDCI/ PRB) Document Processing Desk ( PDCI/ PRB) Adam Heyward Adam Heyward US EPA ( 7510C) Office of Pesticide Programs ( 7510C) 1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2 Washington, DC 20460 1801 South Bell Street Arlington, VA 22202 33 A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic database supporting the reregistration of PHMB has been reviewed and determined to be substantially complete. However, the following additional data requirements have been identified by the Agency as confirmatory and included in the generic DCI for this RED.

The Agency has established an interim two tiered system for toxicology testing requirements. Tier I toxicology data requirements would apply to all indirect food additives that result in residue concentrations ranging from 0 200ppb which applies to PHMB. The requirements would consist of an acute toxicity testing battery, subchronic toxicity study in the rodent, a developmental toxicity study in the rat, and a mutagenicity testing battery. Each of these data requirements has been fulfilled for PHMB. The Agency also conducts a literature search and can also conduct a Structural Activity Relationship analysis ( SAR) if appropriate. The Agency also will hold in reserve a two generation reproduction toxicity study in the rat and a subchronic toxicity study in a non rodent which would become data requirements if the Agency's evaluation of the Tier 1 data warranted. A 2 generation reproduction study and a subchronic toxicity study in a non rodent species are available for PHMB.

Tier II studies would be triggered by the presence of significant ( i. e. > 200ppb) residues in food or evidence of significant toxicity from the Tier I data set, which may include developmental / reproductive, or other systemic toxicity such as presence of neoplastic growth or significant target organ toxicity. In such cases, chronic toxicity and carcinogenicity testing would be required.

The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure data available from the Chemical Manufacturers Association ( CMA) data base. Therefore, the Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data within this risk assessment. The risk assessment also noted that many of the use parameters ( e. g., amount handled and duration of use) were based on professional judgments. Therefore, descriptions of human activities associated with the uses assessed are required as confirmatory.

Table 11. Confirmatory Data Requirements for Reregistration Guideline Study Name New OPPTS Guideline No. Old Guideline No.

Dermal Indoor Exposure 875.1200, 875.1600 233, 236 Inhalation Indoor Exposure 875.1400, 875.1600 234, 236 Descriptions of Human Activity 875.2800 133 1 Dietary Residues in Food from Treating Countertops with PHMB ( FDA Wipe Study Methodology) ( FDA, 2003a and 2003b) Non Guideline Non Guideline 34 2. Labeling for Technical and Manufacturing Use Products To ensure compliance with FIFRA, technical and manufacturing use product ( MP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies. The Technical and MP labeling should bear the labeling contained in Table 13, Label Changes Summary Table.

B. End Use Products 1. Additional Product Specific Data Requirements Section 4( g)( 2)( B) of FIFRA calls for the Agency to obtain any needed product specific data regarding the pesticide after a determination of eligibility has been made. The Registrant must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product.

A product specific data call in, outlining specific data requirements, will be sent to registrants at a later date. The efficacy studies the Agency intends to call in are listed in Table 12 below.

Table 12. Efficacy Data Requirements for Reregistration Claim Use Pattern EPA Reg. Nos. Guideline Study Name New OPPTS Guideline No. Old Guideline No.

Disinfectant Hard inanimate surfaces 71661 1 AOAC Use Dilution Test ( Hard water and organic soil) or AOAC Germicidal Spray Test or AOAC Hard Surface Carrier Test ( Distilled water only) 810.2100 ( c), ( d), ( e) 91 2 ( b), ( c), ( d)

Sanitizer Non food contact surfaces ( nonresidual 5813 75 Sanitizer Test for Hard Inanimate Non Food Contact Surfaces 810.2100 ( l) 91 2 ( j)

Sanitizer Swimming Pools/ Spas 1258 1263 1258 1265 1258 1275 7124 105 69461 1 71864 2 81002 2 AOAC Method for Water Disinfectants for Swimming Pools 810.2700 ( d) 91 8 ( c)

2. Labeling for End Use Products Labeling changes are necessary to implement measures outlined in Section IV above. Specific language to incorporate these changes is specified in Table 13. 35 Registrants may generally distribute and sell products bearing old labels/ labeling for 26 months from the date of the issuance of this Reregistration Eligibility Decision document. Persons other than the registrant may generally distribute or sell such products for 52 months from the approval of labels reflecting the mitigation described in this RED. However, existing stocks time frames will be established case by case, depending on the number of products involved, the number of label changes, and other factors. Refer to " Existing Stocks of Pesticide Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26, 1991.

a. Label Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measure outlined in Section IV. The following table describes how language on the labels should be amended. 36 Table 13. Labeling Changes Summary Table Description Amended Labeling Language Placement on Label For all Manufacturing Use Products " Only for formulation into algicides, bacteriostats/ bacteriocides, fungistats/ fungicides,

microbiostats/ microbiocides, disinfectants, regulators, and sanitizers for the following uses:

hard surfaces ( food contact and non food contact); swimming pools and spas; cut ornamental plants; materials preservatives; drilling muds, packer fluids, and workover fluids; oil field injection water; and tunnel pasteurization water." Directions for Use Environmental Hazards Statements Required by the RED and Agency Label Policies " This product is toxic to fish and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System ( NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." Precautionary Statements End Use Products Intended for Occupational Use PPE Requirements1 " Wear goggles or face shield when handling concentrate." Immediately following/ below Precautionary Statements: Hazards to Humans and Domestic Animals Engineering Controls for Formulations Used in Drilling Muds and Workover Fluids " Scenarios involving drilling muds and workover fluids must use metering pump systems." Precautionary Statements: Hazards to Humans and Domestic Animals ( Immediately Following User Safety Requirements.) 37 User Safety Recommendations " User Safety Recommendations Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.

Users should remove clothing/ PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing*. As soon as possible, wash thoroughly and change into clean clothing." Precautionary Statements under:

Hazards to Humans and Domestic Animals ( Immediately Following Engineering Controls ( Must be placed in a box.)

Environmental Hazards  for Labels with Oil Recovery Uses " Not for use in oil recovery systems which employ holding ponds for spent liquids. Do not apply in, over, or near marine and/ or estuarine oil fields." Directions for Use End Use Products Intended for Residential Use PPE Requirements1 " Wear goggles or face shield when handling concentrate." Immediately following/ below Precautionary Statements: Hazards to Humans and Domestic Animals Application Restrictions For Products Used in Swimming Pools/ Spas " Do not use with chlorine or bromine based pool products." Directions for Use under General Precautions and Restrictions Application Restrictions For Products Used on Food Contact Surfaces " Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes,

or utensils." Directions for Use under General Precautions and Restrictions 38 Application Restrictions For Products Used in Animal/ Pet Areas " Remove animals and feeds. Remove litter, droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances. Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces." Directions for Use under General Precautions and Restrictions Application Restrictions For Products Used in Mushroom Houses " Do not apply directly to the mushroom crop, compost, or casing. Rinse treated surfaces with potable water before they contact the crop, compost, or casing." Directions for Use under General Precautions and Restrictions Entry Restrictions For Products Used in Animal/ Pet Areas,

Veterinary Offices, and Pet Kennels " Wait for treatment to have dried to house animals or employ equipment." Directions for use under General Precautions and Restrictions 1 PPE that is established on the basis of Acute Toxicity of the end use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93 7. 39 VI. APPENDICES 40 Appendix A. Table of Use Patterns for PHMB Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Agricultural premises and equipment Hog Barns/ Houses/ Parlors/

Pens ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Farm Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Farrowing Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

1 Application rate is given in terms of end use product, not active ingredient. 41 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Livestock Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Livestock Feeding Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Livestock Premises ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse. 42 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Livestock Watering Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Mushroom House Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Do not apply directly to the mushroom crop,

compost, or casing. Rinse treated surfaces with potable water before they contact the crop,

compost, or casing.

Poultry Feeding Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Poultry House Premises ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse. 43 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Poultry Watering Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove all animals/ feed. Remove all litter and manure. Empty feeding/ watering appliances.

Ventilate buildings, vehicles, and other enclosed spaces. Do not house animals or employ equipment until treatment has been absorbed, set,

or dried. Thoroughly scrub all feeding/ watering appliances with soap or detergent and rinse with potable water before reuse.

Food handling/ storage establishments premises and equipment Tunnel Pasteurization/ Cooling ( Bottle/ Can Wash) Water Aqueous Solution ( Reg. 1258

1253) 100 1,000 ppm Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Eating Establishments ( Non Food Contact Surfaces, Premises, Food

Contact Surfaces) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Commercial, institutional and industrial premises and equipment Commercial Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Commercial Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 44 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Commercial Transportation Facilities Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Industrial Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Industrial Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Institutional Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Institutional Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Athletic Facilities Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Barber and Beauty Shop Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Aircraft ( NonFeed/ Food) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 45 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Buses ( Nonfeed/ Nonfood) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Railroad Trains Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Ships Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Trucks Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Animal Cages Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Animal Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment. 46 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Animal Feeding/ Watering Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Catteries ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Horse Stables ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Research Animal Facilities ( Enclosed Premise Treatment)/

Animal Laboratories Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment. 47 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Veterinary Hospital Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Zoo Premises ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Laundry Premises ( Commercial) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Urinals Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Coils/ Drain Pans ( Air Conditioning/

Refrigeration Equipment and Heat Pumps)

( Commercial/

Institutional/ Industrial) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Playground Equipment ( Institutional) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 48 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Residential and public access premises Automobiles Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Boat Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Pet Kennels ( Enclosed Premise Treatment) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Pet Sleeping Quarters Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment.

Pet Areas Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Remove animals and feeds. Remove litter,

droppings, and manure from all floors and other surfaces. Empty all feeding/ watering appliances.

Rinse all food contact surfaces with potable water prior to reuse. Ventilate buildings/ closed spaces.

Wait for treatment to have dried to house animals or employ equipment. 49 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Campers Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Garbage Containers Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Laundry Premises ( Residential) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Sinks Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Stovetops Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse.

Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Residential Food Contact Surfaces ( Microwave Ovens/ Refrigerators/

High Chairs/ Tables) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 50 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Bathroom Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Whirlpool Bath Surfaces Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Diaper Pails Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Domestic Dwellings ( House Trailer) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Household Contents Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Household Contents ( Nursery) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 51 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Ready to Use Solution ( Mopping System)

( Reg. 5813 75) 24 fl. oz. lasts about 2 3 months under " normal use"  mop has trigger to dispense solution Household Floors Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Household Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Mobile Homes ( Indoor) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Coils/ Drain Pans ( Air Conditioning/

Refrigeration Equipment and Heat Pumps)

( Residential) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 52 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Powder ( Water Soluble Packaging)

( Reg. 72992 2;

72992 8) 10g per 2.6 quarts of water 0.17 oz ( 5g) per pint ( ½ qt) of water 2 Ornamental Flowering Plants ( Cut) Soluble Concentrate ( Reg. 72992 3;

72992 7) 10,000  15,000 ppm solution 3 Furniture ( Outdoor) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.