United States Prevention, Pesticides EPA738 R 05 001 Environmental Protection and Toxic Substances January 2005 Agency ( 7508C)

Reregistration Eligibility Decision for Para Tertiary Amylphenol, Potassium Sodium Salt ( Case 3016) 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, Para Tertiaryamylphenol ( 4 t amylphenol). The enclosed Reregistration Eligibility Decision ( RED) document was approved on September 30, 2005. Public comments and additional data received were considered in this decision.

Based on its review, EPA is now publishing its Reregistration Eligibility Decision ( RED) and risk management decision for 4 t amylphenol 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 4 t amylphenol are available to the public in EPA's Pesticide Docket OPP 2005 0181 at: http:// www. epa. gov/ edockets.

The 4 t amylphenol RED was developed through EPA's public participation process, published in the Federal Register on July 20, 2005, which provides opportunities for public involvement in the Agency's pesticide tolerance reassessment and reregistration programs. Developed 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 4 t amylphenol 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 4 t amylphenol 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 4 t amylphenol will be eligible for reregistration provided that all the conditions identified in this document are satisfied, including implementation of the risk mitigation measures outlined in Section IV of the document. Sections IV and V of this RED document describe labeling amendments for end use products and data requirements necessary to implement these mitigation measures. Instructions for registrants on submitting the revised labeling can be found in the set of instructions for product specific data that accompanies this document.

Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the Agency will continue to have concerns about the risks posed by 4 t amylphenol. Where the Agency has identified any unreasonable adverse effect to human health and the environment, the Agency may at any time initiate appropriate regulatory action to address this concern. At that time, any affected person( s) may challenge the Agency's action.

If you have questions on this document or the label changes necessary for reregistration, please contact the Chemical Review Manager, Killian Swift, at ( 703) 308 6346. For questions about product reregistration and/ or the Product DCI that accompanies this document, please contact Adam Heyward at ( 703) 308 6422.

Sincerely,

Frank Sanders, Director Antimicrobials Division ( 7510C) REREGISTRATION ELIGIBILITY DECISION for Para tertiary amylphenol List C CASE 3016 Approved By:

Frank Sanders Director, Antimicrobials Division Date: September 30, 2005 Attachment ix Table of Contents Glossary of Terms and Abbreviations                 .. xvi 4 t amylphenol Reregistration Team                  . xiv Executive Summary                        .... xv I. Introduction                           .. 1 II. Chemical Overview                       . .. 3 A. Regulatory History                    .. 3 B. Chemical Identification                   .. 3 C. Use Profile                        ... 4 III. Summary of 4 t amylphenol Risk Assessments            . 6 A. Human Health Risk Assessment                6 1. Toxicity of 4 t amylphenol              . 6 2. FQPA Safety                       8 3. Population Adjusted Dose ( PAD)            ... 9 a. Acute PAD                    9 b. Chronic PAD                  9 4. Exposure Assumptions                  10 5. Dietary ( Food) Risk Assessment             . 10 a. Acute Dietary Risk               .. 10 b. Chronic ( Non Cancer) Dietary Risk        .. 10 c. Dietary Risks from Drinking Water        .. 11 6. Residential Exposure...                  11 a. Toxicity                    . 12 b. Residential Handler ...             .. 13 i. Exposure Scenarios, Data and Assumptions  .. 13 ii. Residential Handler Risk Estimates     .. 14 c. Residential Post application  .          . 14 i. Exposure Scenarios, Data and Assumptions  .. 14 ii. Residential Post Application Risk Estimates . 15 7. Aggregate Risk                     16 a. Short and Intermediate Term Aggregate Risk ....  .. 17 b. Long Term Aggregate Risk           .. 18 8. Occupational Risk                  ... 18 a. Occupational Toxicity              . 19 b. Occupational Handler Exposure           19 c. Occupational Handler Risk Summary       ... 19 d. Occupational Post Application Risk Summary     21 e. Human Incident Data              .. 21 B. Environmental Risk Assessment               .. 21 x 1. Environmental Fate and Transport           ... 21 2. Ecological Risk                     22 3. Endocrine Effects in Fish                 23 4. Listed Species Consideration               . 24 a. The Endangered Species Act  .         . 24 b. General Risk Mitigation ..            25 IV. Risk Management, Reregistration, and Tolerance Reassessment Decision  26 A. Determination of Reregistration Eligibility            26 B. Public Comments and Responses               . 26 C. Regulatory Position                      27 1. Food Quality Protection Act Considerations       ... 27 a. " Risk Cup" Determination            . 27 b. Determination of Safety to U. S. Population     . 27 c. Determination of Safety to Infants and Children    28 d. Endocrine Disruptor Effects           .. 28 e. Cumulative Risks                . 29 2. Tolerance Summary                  29 a. Tolerances Currently Listed and Tolerance Reassessment                 29 b. Codex Harmonization               30 D. Regulatory Rationale                    .. 30 1. Human Health Risk Management            . 30 a. Dietary ( Food) Risk Mitigation          . 30 b. Drinking Water Risk Mitigation         .. 30 c. Residential Risk Mitigation             30 d. Occupational Risk Mitigation            31 i. Handler Exposure             . 31 ii. Post Application Risk Mitigation      . 31 2. Environmental Risk Management          .. 31 3. Other Labeling Requirements               31 4. Threatened and Endangered Species Considerations    .. 32 a. The Endangered Species Program         . 32 b. General Risk Mitigation            .. 32 V. What Registrants Need to Do                   .. 34 A. Manufacturing Use Products                  36 1. Additional Generic Data Requirements         .. 36 2. Labeling for Technical and Manufacturing Use Products  .. 38 B. End Use Products                    .. 38 1. Additional Product Specific Data Requirements    .......... 38 2. Labeling for End Use Products             .. 38 a. Label Changes Summary Table          . 39 xi VI. Appendices                           . 41 A. Table of Use Patterns for 4 t amylphenol             43 B. Table of Generic Data Requirements and Studies Use to Make the Reregistration Decision                 . 68 C. Technical Support Documents                 73 D. Bibliography Citations                   . 74 E. Generic Data Call In                    . 79 F. Product Specific Data Call In                  80 G. Batching of End Use Products                . 81 H. List of All Registrants Sent the Data Call In          .. 83 I. List of Available Forms                   .. 84 xii 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 xiii MRID Master Record Identification ( number). EPA's system of recording and tracking studies submitted. MRL Maximum Residue Level N/ A Not Applicable NASS National Agricultural Statistical Service NAWQA USGS National Water Quality Assessment NG No Gloves NMFS National Marine Fisheries Service NOAEC No Observed Adverse Effect Concentration NOAEL No Observed Adverse Effect Level NPIC National Pesticide Information Center NR No respirator OP Organophosphorus OPP EPA Office of Pesticide Programs ORETF Outdoor Residential Exposure Task Force PAD Population Adjusted Dose PCA Percent Crop Area PDCI Product Specific Data Call In 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 PCCs Poison Control Centers 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 xiv 4Para Tertiary Amylphenol Reregistration Team Office of Pesticide Programs Environmental Fate and Effects Risk Assessment Srinivas Gowda David Bays Health Effects Risk Assessment Jonathan Chen Timothy Leighton Tim McMahon Siroos Mostaghimi Myron Ottley Bob Quick Najm Shamim Deborah Smegal Cassi Walls Registration Support Adam Heyward Risk Management Ben Chambliss Killian Swift ShaRon Carlisle xv 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 para tertiary amylphenol ( 4 t amylphenol) and its potassium and sodium salt and is issuing its risk management decision. The Agency has determined 4 t amylphenol and its potassium and sodium salts are eligible for reregistration provided all measures outlined in this document are implemented. 4 t Amylphenol is a member of the phenolic class of antimicrobials. 4 t Amylphenol is an active ingredient in disinfectant, food contact sanitizer and deodorizer products used in agricultural, food handling, commercial, institutional, industrial, residential, public access, and medical settings, primarily on hard, non porous surfaces. The majority of the products are virucidal, fungicidal, tuberculocidal or bactericidal. Examples of registered uses for 4 t amylphenol include application to hard surfaces ( e. g., walls, floors, tables, fixtures), textiles ( e. g., clothing, diapers, mattresses, bedding), carpets, medical instruments, and agricultural equipment. Additionally, there are registered uses for fogging in occupational settings and air deodorization in both occupational and residential settings.

Overall Risk Summary The Agency's human heath risk assessment indicates no risks of concern for dietary or drinking water exposures. An acute dietary risk estimate was completed for females 13 49 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.

4 t Amylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. Thus, a drinking water assessment was not conducted. Therefore, no risk mitigation measures are required to address 4 t amylphenol exposure from drinking water.

Residential risks from handler and post application exposure were calculated for shortand intermediate term dermal, inhalation and incidental oral exposures. All exposure and risk estimates for residential handler scenarios are below the Agency's level of concern. Risks of concern have been identified for several post application exposure scenarios including children's dermal exposure to treated clothing and treated diapers and children's incidental oral exposure to treated clothing. The Agency believes that adding clear instructions for washing and rinsing textile items will result in the adequate removal of residues from the treated items and address the Agency's concerns for this scenario. The MOE for dermal exposure to children to treated surfaces in daycare centers slightly exceeds the Agency's level of concern ( MOE = 940 with a target MOE of 1,000). However, the Agency believes actual exposure from this pathway to not exceed its level of concern when taking into account the conservative nature of the risk estimate which is likely to overestimate potential exposures. xvi Aggregate short and intermediate term risk assessments were conducted for this chemical that includes incidental oral and inhalation risks only. Dermal risks are not included in the aggregate risk estimates because they have a different toxicity endpoint. The aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is greater than the target of 3,000. For children, the aggregate risk estimates are also above the target MOE of 3,000 and thus are not of concern. However, incidental oral exposures to treated textiles are not included in the aggregate assessment because the oral MOE is already of concern.

For the occupational handler dermal and inhalation risk assessment, the short and intermediate term risks calculated at baseline exposure ( no gloves and no respirators) were above target MOEs for all scenarios. For most of the occupational scenarios, postapplication dermal exposure is not expected to occur or is expected to be negligible based on the application rates and chemical properties of the chemical. Postapplication/ bystander inhalation exposures, however, were assessed for entry into a building after a fogging application. The representative building selected was a poultry barn. The calculated inhalation MOEs were above the target MOE of 300 for all fogging postapplication scenarios with the exception of the scenario for 8 hr exposure to the product with a 2 hr reentry interval ( MOE = 86).

There is a concern about the possibility of endocrine disruption in fish, since 4 tamylphenol is considered an ecoestrogen. However, since this chemical is restricted to indoor uses only, the possibility for exposure to fish to 4 t amylphenol would be limited. The limited exposure resulting from indoor uses of 4 t amylphenol and its salts is not anticipated to cause adverse effects to terrestrial or aquatic organisms.

Dietary Exposure Risk An acute dietary risk assessment was conducted for 4 t amylphenol indirect food uses. Dietary risk estimates are provided for females 13 49 years old, the only population subgroup for which an endpoint was selected. The result of this assessment showed the risk estimate to be 2.7% of the aPAD and therefore is not of concern A chronic dietary risk assessment was conducted for 4 t amylphenol food uses. The risk analysis assumes daily exposure from the hard surface disinfection of counter tops. The result of this assessment showed the risk estimates to be < 42% of the cPAD and therefore are not of concern.

Drinking Water Risk 4 t Amylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. There are no currently registered outdoor uses of 4 t amylphenol and its salts. Further, the estimated value for biodegradation indicates it may biodegrade linearly within days in the aquatic environment, although ultimate biodegradation ( mineralization) may take months. It also is volatile based on its vapor pressure of 0.00116 mmHg, and has a moderate to slight mobility in soils based on its estimated Koc value of 3799. The sodium and potassium salts of 4 t amylphenol also are slightly to moderately mobile in xvii soils, and are estimated to biodegrade within days to weeks. Because of the possibility of biodegradation in water and soils and the lack of outdoor uses, 4 t amylphenol and its salts are not likely to contaminate surface and ground waters. Thus, a drinking water assessment was not conducted.

Residential Handler Risk For residential handlers that handle products containing 4 t amylphenol and its salts, short term, and intermediate term MOEs were above the target MOEs ( i. e.,   > 1,000 for dermal and > 3,000 for inhalation) for all scenarios evaluated and thus, do not exceed the Agency's level of concern.

Residential Post Application Risk Risks of concern have been identified for several post application exposure scenarios including children's dermal exposure to treated clothing and treated diapers and children's incidental oral exposure to treated clothing. The Agency believes that adding clear instructions for washing and rinsing textile items will result in the adequate removal of residues from the treated items and address the Agency's concerns for this scenario. The MOE for dermal exposure to children to treated surfaces in daycare centers slightly exceeds the Agency's level of concern ( MOE = 940 with a target MOE of 1,000). However, the Agency believes actual exposure from this pathway to not exceed its level of concern when taking into account the conservative nature of the risk estimate which is likely to overestimate potential exposures.

Aggregate Risk Short and intermediate term aggregate risks are considered together because the exposure and toxicity endpoints are identical for incidental oral and inhalation residential exposures for both durations. For children, the short and intermediate term aggregate assessment includes average dietary exposure ( food) and estimated incidental oral exposures to children from residential uses such as hard surface disinfection. In addition, inhalation exposure from post application of an air deodorizer use was aggregated with the oral exposures since the toxicity endpoint is the same. For adults, the aggregate assessment includes dietary ( oral) and residential inhalation exposures from wiping a hard surface disinfectant, in addition to post application inhalation exposure from the air deodorizer.

Aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is greater than the target of 3,000. For children, the aggregate risk estimates are also above the target MOE of 3,000 and thus are not of concern. As noted previously, incidental oral exposures to treated textiles are not included in the aggregate assessment because the oral MOE is already of concern.

A dermal aggregate assessment was not conducted because the toxicity effects for the dermal exposure route are not the same as the oral/ inhalation exposure route. However, short xviii and intermediate dermal risks are already of concern for residents for the treated textile and diaper use.

Occupational Risk To assess the handler risks, the Agency used surrogate unit exposure data from both the proprietary Chemical Manufacturers ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED). For the occupational handler dermal and inhalation risk assessment, the short and intermediate term risks calculated at baseline exposure ( no gloves and no respirators) were above target MOEs for all scenarios ( i. e., dermal MOEs > 100 and inhalation MOEs were > 300). Note, however, that high pressure spray application method in the agricultural use site category was assessed using gloved data.

For most of the occupational scenarios, post application dermal exposure is not expected to occur and it is expected to be negligible based on the application rates and chemical properties of the chemical. However, post application/ bystander inhalation exposures were assessed for entry into a building after fogging application. The representative building selected was a poultry barn. The Agency used MCCEM ( Multi Chamber Concentration and Exposure Model) to estimate post application/ bystander exposures. The calculated inhalation MOEs were above the target MOE of 300 for all fogging post application scenarios with the exception of the scenario for 8 hour exposure to the product with a 2 hour re entry interval ( MOE = 86).

The Agency does not believe that any mitigation is necessary to address the postapplication scenario with a 2 hr reentry interval at this time. The risk estimate was calculated using the Agency's standard assumptions for air exchange rates. The Agency believes that in the case of animal barns and facilities this assumption in very conservative given the relatively high air exchange rates for such facilities.

Ecological Risk There is a concern about the possibility of endocrine disruption in fish, since 4 tamylphenol is considered an ecoestrogen. This was documented in several studies on carp ( Cyprimus carpio). However, since this chemical is restricted to indoor uses only, the possibility for exposure to fish to 4 t amylphenol would be limited. The limited exposure resulting from indoor uses of 4 t amylphenol and its salts is not anticipated to cause adverse effects to terrestrial or aquatic organisms.

Regulatory Decision The Agency has completed its review and has determined that the data are sufficient to support reregistration of all supported products containing 4 t amylphenol. The Agency is issuing this RED for 4 t amylphenol, as announced in a Notice of Availability published in the Federal Register. This RED document includes guidance and time frames for making any necessary label changes for products containing 4 t amylphenol. xix Summary of Mitigation Measures The Agency has determined that 4 t amylphenol and its salts ( potassium and sodium) are eligible for reregistration provided the mitigation measures described in this document and the label changes included in Table 13 in Section V of the RED are implemented.

Residential Risk Mitigation To reduce residential exposure, the Agency has determined that the following mitigation and label changes for specific scenarios are appropriate and required for reregistration eligibility:

 Delete all diaper uses  Delete all use on non laundered textiles\ items including mattresses, helmets, headgear, headphones, facegear, and mouthpieces.  All labels with laundered textile uses must have directions that indicate that items must be treated prior to washing and rinsing. 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 4 tertiary amylphenol ( 4 t amylphenol), and salts ( potassium and sodium).

4 t Amylphenol and salts are active ingredients in disinfectant and food contact sanitizer products used in agricultural, food handling, commercial/ institutional/ industrial, residential, public access, and medical settings   primarily on hard, non porous surfaces. The majority of the products are virucidal, fungicidal, bactericidal, pseudomonacidal, or staphylocidal. Examples of registered uses for 4 t amylphenol and salts include application to hard surfaces ( e. g., walls, floors, tables, and fixtures), textiles ( e. g., clothing, diapers, mattresses, and bedding), carpets, medical instruments, and agricultural equipment. Additionally, there are registered uses for fogging in occupational settings and air deodorization in both occupational and residential settings. Concentrations of 4 t amylphenol and salts in products range from 0.0027% to 10%. The products are formulated as soluble concentrates, ready to use liquid solutions, pressurized sprays, and impregnated wipes.

The Agency has concluded that the hazard based FQPA safety factor should be retained at 10X. The toxicology data base is not complete with respect to assessing the increased susceptibility to infants and children as required by FQPA for 4 t amylphenol. The rat prenatal developmental study showed no quantitative evidence of increased susceptibility ( i. e., developmental NOAELs / LOAELs were higher than those for maternal effects). However, there was qualitative evidence of increased susceptibility as the fetal effects ( i. e., skeletal abnormalities, decreased body weight gain) were considered to be more severe than maternal toxicity ( reversible clinical signs). In addition, there is an absence of developmental toxicity data in the rabbit, and an absence of reproductive toxicity data. Furthermore, studies in the open 2 literature suggest that 4 t amylphenol may be an endocrine disruptor. It increased non pregnant uterine weight in rats and was associated with elevated blood levels of billirubin in children exposed to 4 t amylphenol and other phenols in disinfectants. These studies, while not indicative, are suggestive of a basis for increased concern for reproductive and/ or developmental effects due to exposure to 4 t amylphenol.

Risks summarized in this document are those that result only from the use of the active ingredients 4 t amyphenol and its salts ( potassium and sodium). 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 lowlevel 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 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 4 t amyphenol and its salts ( potassium and sodium) and any other substances. 4 t Amyphenol and it salts ( potassium and sodium) do not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that 4 t amyphenol and it salts ( potassium and sodium) 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 4 t amyphenol and its salts ( potassium and sodium). 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 4 t amylphenol and salts 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 ( OPP 2005 0181)

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 4 t amylphenol and its salt ( potassium and sodium), and its regulatory history. Section III, Summary of 4 t amylphenol and salts Risk Assessment, 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 4 t Amyphenol and its salts ( potassium and sodium) have been registered for use since 1962. Currently, there are 35 products containing 4 t amyphenol ( one technical product and 34 end use products) registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA).

B. Chemical Identification 1. Para Tertiary Amylphenol & its Potassium and Sodium Salts OH C CH3 CH3 C H H CH3 O  Na + CH 3 CH 3 CH 3 P aratertiaryam yl P h enol, S o dium S a lt O  K + CH 3 CH 3 CH 3 P aratert iaryam yl P hn eo l, P o tass ium S a lt Common name: Para Tertiary amylphenol Chemical name: 4 tertiary amylphenol, and salts Chemical Family: Antimicrobial Disinfectant 4 Empirical formula: C5H11C6H4OH ( 064101) C5H11C6H4Na+ ( 064111)

C5H11C6H4K+ ( 064112)

CAS Registry No.: 064101: 80 46 6 ( 4 t amylphenol) 064111: 53404 18 5 ( sodium salt) 064112: 31366 95 7 ( potassium salt)

Case number: 3016 OPP Chemical Code: 064101, 064111, 064112 Molecular weight: 164.25 ( 064111)

Trade name: Nipacide PTAP Basic manufacturer: Clariant Corporation Technical 4 t amylphenol is a white solid. 4 t Amylphenol has a melting point of 95 E C. The water solubility of 4 t amylphenol is 113.4 ppm. 4 t Amylphenol has a vapor pressure of 1.16 x 10 3 mm Hg at 25o C.

Sodium 4 tert amylphenate is also a solid with an estimated melting point of 205 E C, water solubility of 4,595 ppm and an estimated vapor pressure of 7.7 x10 10 at 25oC. Potassium 4 tert amylphenate is also a sold with an estimated melting point of 206 E C, water solubility of 3,811 ppm and an estimated vapor pressure of 7.7 x10 10 at 25oC.

C. Use Profile The following is information on the currently registered uses of 4 t amylphenol and salts products and an overview of use sites and application methods. A detailed table of the uses of eligible for reregistration is contained in Occupational and Residential Exposure Assessment for this RED.

Type of Pesticide: Antimicrobial Summary of Use:

Food: 4 tert amylphenol and its salts are applied to the following use sites, which may result in indirect food contact: commercial egg washing, handling, hatchery, and processing facilities; milking equipment; and mushroom houses.

Non Food: Farm and agricultural equipment and structures/ premises; beverage processing plants; eating establishment surfaces, equipment, and utensils; 5 food storage and distribution equipment and utensils; and food dispensing equipment.

Residential: Air deodorizer in residential premises, hard surface disinfection, textiles, and carpets.

Target Pests: Viruses, fungi, tuberculocidal microbes, bacteria, pseudomonacidal microbes, and staphylocidal microbes.

Formulation Types: Soluble concentrates, ready to use liquid solutions, pressurized sprays, and impregnated wipes Method and Rates of Application:

Equipment: Mops, wipes, trigger pump sprayer, aerosol.

Application Rates: Concentrations of 4 t amylphenol and salts products range from 0.0027% to 10%.

Timing: Most labeling indicates product needs to remain on surface for at least a 10 second contact time before it is removed using a potable water rinse. 6 III. Summary of 4 Tert Amylphenol 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 4 t amylphenol. 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 4 tertiary amylphenol A brief overview of the toxicity studies used for determining the dietary endpoints in the risk assessments are outlined in Table 2. Further details on the toxicity of 4 t amylphenol can be found in the " Toxicology Science Chapter for Reregistration Eligibility Decision Document", September 2005; and " 4 t amylphenol Report of the Antimicrobial Division's Toxicology Endpoint Selection Committee ( ADTC)", July 2005. These documents are available on Agency's website in the EPA Docket at http:// www/ epa. gov/ edockets. ( OPP 2005 0181)

The Agency has reviewed all toxicity studies submitted for 4 t amylphenol and has determined that the toxicological database is sufficient for reregistration. Major features of the toxicology profile are presented below. The toxicology database for 4 t amylphenol, in terms of guideline studies, is largely incomplete. 4 t amylphenol appears to be a primary dermal and eye irritant ( Category I), and it may be in Category III for acute oral dermal studies, according to data from the open literature, and two registrant submitted studies. However, four acceptable guideline acute studies are not available, and the literature data protocols were inadequate.

Table 1. Acute Toxicity of 4 t amylphenol Technical Guideline No./ Study Type MRID Number Results Toxicity Category 870.1100 Acute Oral Toxicity 46616601 LD50 > 2000 mg/ kg III 870.1200 Acute Dermal Toxicity Not available; required 870.1300 Acute Inhalation Toxicity Not available; required 870.2400 Acute Eye Irritation Not available; required 870.2500 Acute Dermal Irritation 46616602 Corrosive I 870.2600 Skin Sensitization Not available; required 7 The doses and toxicological endpoints selected for the dietary exposure scenarios are summarized in Table 2 below.

Table 2. Toxicological Endpoints for 4 t amylphenol and salts ( Dietary) Exposure Scenario Dose for Risk Assessment and Uncertainty Factor Special FQPA Safety Factor and Population Adjusted Dose Study and Toxicological Effects Acute Dietary ( Females 13 50 years of age) NOAEL = 200 mg/ kg/ day UF = 100 Acute RfD = 0.67 mg/ kg/ day FQPA SF = 10x aPAD = acute RfD FQPA SF = 0.6 mg/ kg/ day Developmental Toxicity Study in Rats LOAEL = 500 mg/ kg/ day based on skeletal effects and decreased fetal body weight.

Chronic Dietary ( All populations) NOAEL= 50 mg/ kg/ day UF = 100 Chronic RfD = 0.17 mg/ kg/ day FQPA SF = 10x cPAD = chronic RfD FQPA SF = 0.17 mg/ kg/ day Developmental toxicity study in the rat. LOAEL = 200 mg/ kg/ day based on clinical signs of toxicity, decreased body weight and body weight gain, and decreased food consumption.

UF = uncertainty factor, FQPA SF = Special 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, MOE = margin of exposure, N/ A = Not Applicable In short term studies, 4 t amylphenol produced clinical signs along with decreased food consumption and body weight in a developmental toxicity study, but not systemic effects in a 13 week dermal study. The structural abnormalities and developmental delays that occurred in the developmental study occurred at higher dose levels than the maternal effects, suggesting that increased quantitative susceptibility concerns are not warranted. However, the minimal maternal effects ( reversible clinical signs) seen in the presence of developmental effects increases concern for qualitative susceptibility.

Available data suggest that 4 t amylphenol has endocrine disrupter capabilities ( uterotrophic and estrogenic effects) and increased billirubin production in babies. When taken with the lack of available developmental and reproductive toxicity data, concerns for FQPA issues are heightened.

General Toxicity Observations Dietary The acute RfD is 0.67 mg/ kg/ day for females ( 13 50 years), based on adverse developmental effects ( skeletal effects and decreased fetal body weight) at 500 mg/ kg/ day in a rat developmental study. The chronic RfD is 0.17 mg/ kg/ day based on clinical signs of toxicity and decreased body weight and food consumption at 200 mg/ kg/ day in a rat developmental study. An uncertainty factor of 300 ( 10X for interspecies extrapolation, 10X for intraspecies variability, and 3X for database uncertainties) was applied to the NOAEL to obtain the acute and chronic RfDs. A database uncertainty factor of 3x is applied to non occupational risk assessments for 4 t amylphenol, due to the number and significance of the data gaps including lack of repeated oral toxicity studies. An additional Food Quality Protection Factor ( FQPA) safety factor is applied, which is discussed below. 8 Incidental Oral The short and intermediate term incidental oral NOAEL is 50 mg/ kg/ day from a rat oral developmental toxicity study that noted clinical signs, decreases in body weight and body weight gain, coupled with decreased food consumption at 200 mg/ kg/ day. The target margin of exposure ( MOE) is 3,000 ( includes 10X FQPA factor).

Short and Intermediate term Dermal The short and intermediate term dermal NOAEL is 25 mg/ kg/ day, which is based on the lack of systemic effects identified up to and including a dose of 25 mg/ kg/ day in a rat subchronic dermal toxicity study. Uncertainty factors or " target" margins of exposure ( MOE) for 4 tamylphenol dermal exposures are 100 for occupational scenarios and 1,000 for residential scenario ( includes 10X FQPA factor).

Short, Intermediate and Long term Inhalation The short, intermediate and long term inhalation NOAEL is 50 mg/ kg/ day from a rat oral developmental toxicity study that noted clinical signs, decreases in body weight and body weight gain, coupled with decreased food consumption at 200 mg/ kg/ day. In the absence of data, it was conservatively assumed that inhalation absorption is equivalent to oral absorption ( i. e., 100%). For inhalation exposures, the uncertainty factors are 300 for occupational scenarios and 3,000 for residential scenarios ( includes 10X FQPA factor). An additional 3X database uncertainty factor was applied due to the absence of inhalation toxicity data, and studies that address the sensitivity of infants and children. The 3,000 MOE represents the maximum uncertainty that can be applied under Agency guidelines and applies to residential exposures.

Carcinogenicity Classification There are no lifetime carcinogenicity studies available for 4 t amylphenol.

Mutagenicity Potential The data base for mutagenicity is considered adequate based on EPA's 1991 mutagenic guidelines and indicates that 4 t amylphenol 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." 4 t Amylphenol has properties that could indicate Endocrine Disrupting Chemical ( EDC) properties given that available data suggest that 4 t Amylphenol has endocrine disruptor capabilities ( uterotrophic and estrogenic effects) and increased billirubin production in babies.

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 9 retained ( i. e., remains 10X) for 4 t amylphenol based on the limited database, qualitative evidence of sensitivity in the developmental toxicity study, and the suggestive evidence in the open literature of possible endocrine effects.

The toxicology data base is not complete with respect to assessing that increased susceptibility to infants and children as required by FQPA for 4 t Amylphenol. The rat prenatal developmental study showed no quantitative evidence of increased susceptibility ( i. e., developmental NOAELs/ LOAELs were higher than those for maternal effects). However, there was qualitative evidence of increased susceptibility [ i. e., fetal effects ( skeletal abnormalities, decreased body weight gain) were considered to be more severe than the maternal toxicity ( reversible clinical signs) observed at the same dose level]. In addition, there is an absence of developmental toxicity data in the rabbit and an absence of reproductive toxicity data.

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 4 t amylphenol 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 ( 0.67 mg/ kg/ day) modified by the FQPA safety factor. The acute reference dose was derived from a developmental toxicity study in rats in which both the NOAEL ( 200 mg/ kg/ day) and the LOAEL ( 500 mg/ kg/ day) were determined. Acute dietary exposure was estimated only for females ages 13 49 because available studies did not show a toxicity endpoint attributable to a single exposure for the general population. The 4 t amylphenol aPAD is 0.067 mg/ kg/ day based on a reference dose of 0.6 mg/ kg/ day, and incorporating the FQPA safety factor of 10X.

b. Chronic PAD Chronic dietary risk for 4 t Amylphenol 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 ( 0.17 mg/ kg/ day) modified by the FQPA safety factor. The cPAD was derived from a developmental toxicity study in rats in which both the NOAEL ( 50 mg/ kg/ day) and the LOAEL ( 200 mg/ kg/ day) were determined. The 4 t amylphenol cPAD is 0.017 mg/ kg/ day based on a reference dose of 0.17 mg/ kg/ day, which includes the incorporation of the FQPA safety factor ( 10X) for the overall U. S. population or any population subgroups. 10 4. Exposure Assumptions The use of antimicrobial chemicals on food or feed contact surfaces, agricultural commodities, in animal premises and poultry premises including hatcheries and application to food grade eggs may result in pesticide residues in human food. The Agency must determine the risk to human health that may occur from exposure to these chemicals.

Refrigerators, counter tops, sinks and stoves are use sites on registered labels. These surfaces that have been treated with the 4 t amylphenol products may bear small residues of the 4 t amylphenol products after rinsing with potable water; i. e., rinsing with potable water may not remove all residues deposited on the treated surfaces from the proposed uses. Residues from treated surfaces can migrate to food coming into contact with the treated and rinsed surfaces and can be ingested by humans.

In the absence of residue data for 4 t amylphenol on treated food contact surfaces, the Agency estimated residue levels that may occur in food using the highest application rate for food contact surfaces. To estimate the Estimated Daily Intake ( EDI), the Agency has used an FDA model. The maximum ingredient percentage for 4 t amylphenol in food handling establishments from the various labeled ready to use products is 0.054 % a. i ( 540 ppm). The Agency assumed that food can contact 2000 cm2 of treated surfaces, and that 10% of the pesticide migrates to food based on the Agency Residential SOPs. The use of the 10% transfer rate instead of the use of a 100% transfer rate that is used in the FDA Sanitizer Solution Guidelines requires the submission of confirmatory data to establish the reliability of the use of the10% transfer rate. These daily estimates were conservatively used to assess both acute and chronic dietary.

5. Dietary ( Food) 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 3.

a. Acute Dietary Risk An acute dietary risk assessment was conducted for 4 t amylphenol food uses. Dietary risk estimates are provided for females 13 49 years old, the only population subgroup for which an endpoint was selected. The result of this assessment showed the risk estimate to be 2.7% of the aPAD and therefore is not of concern b. Chronic ( Non cancer) Dietary Risk A chronic dietary risk assessment was conducted for 4 t amylphenol food uses. The risk analysis assumes daily exposure from the hard surface disinfection of counter tops. The result of this assessment showed the risk estimates to be < 42% of the cPAD and therefore are not of 11 concern. However, since the Agency assumed 10% of the residues are transferred to foods it is requiring confirmatory data for this transfer rate because 100% residue transfer indicates risks of concern.

Table 3: Acute and Chronic Dietary Exposure and Risk Acute Dietary Chronic Dietary Population Subgroup Dietary Exposure ( mg/ kg/ day) a % aPAD b Dietary Exposure ( mg/ kg/ day) a % cPAD b adult male 0.0015 NA 0.0015 9 females ( 13 50 years) 0.0018 2.7 0.0018 10.6 infants/ children 0.0072 NA 0.0072 42 NA= not applicable b. Dietary Risk from Drinking Water 4 t Amylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. There are no currently registered outdoor uses of 4 t amylphenol and its salts. Further, the estimated value for biodegradation indicates it may biodegrade linearly within days in the aquatic environment, although ultimate biodegradation ( mineralization) may take months. It also is volatile based on its vapor pressure of 0.00116 mmHg, and has a moderate to slight mobility in soils based on its estimated Koc value of 3799. The sodium and potassium salts of 4 t amylphenol also are slightly to moderately mobile in soils, and are estimated to biodegrade within days to weeks. Because of the possibility of biodegradation in water and soils and the lack of outdoor uses, 4 t amylphenol and its salts are not likely to contaminate surface and ground waters. Thus, a drinking water assessment was not conducted.

6. Residential Exposure Residential exposure assessment considers all potential pesticide exposure, other than exposure due to residues in food or in drinking water. Exposure may occur during and after application as a hard surface disinfectant ( e. g., walls, floors, tables, fixtures), to textiles ( e. g., clothing, diapers, mattresses, bedding) and to carpets. Each route of exposure ( oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a Margin of Exposure ( MOE), which is the ratio of estimated exposure to an appropriate NOAEL. Based on its use patterns, 4 t amylphenol has been assessed for the residential mixing/ loading/ applicator ( or " handler") exposure for applications by homeowners mopping, wiping and spraying hard surfaces. For post application exposure, 4 t amylphenol has been assessed for adults and children contacting treated hard surfaces/ floors, wearing treated clothing, wearing treated diapers ( children), mouthing treated textiles ( children) and bystander inhalation exposure. 12 a. Toxicity The toxicological endpoints and associated uncertainty factors used for assessing the nondietary risks for 4 t amylphenol are listed in Table 4.

A MOE greater than or equal to 3,000 is considered adequately protective for the residential exposure assessment for the incidental oral and inhalation routes of exposure. The MOE of 3,000 includes 10x for interspecies extrapolation, 10x for intraspecies variation, 3x for database uncertainty and the 10x FQPA factor. For the dermal route of exposure, a MOE greater than or equal to 1,000 is considered adequately protective for the residential exposure assessment. The MOE of 1,000 includes 10x for interspecies extrapolation, 10x for intraspecies variation and the 10x FQPA factor.

Table 4: Toxicity Endpoints Selected for Assessing Occupational and Residential Risk for 4 t Amylphenol Exposure Scenario Dose Used in Risk Assessment Level of Concern for Risk Assessment Study and Toxicological Effects Incidental Oral, Short and Intermediate Term Maternal Oral NOAEL = 50 mg/ kg/ day Residential LOC for MOE = 3000 Occupational = NA Developmental toxicity study in the rat LOAEL = 200 mg/ kg/ day based on clinical signs of toxicity, decreased body weight and body weight gain, and decreased food consumption Short, and Intermediate  Term Dermal Dermal NOAEL = 25 mg/ kg/ day for systemic effects Residential LOC for MOE = 1000 Occupational = 100 Subchronic dermal toxicity study in Rats Systemic LOAEL = not identified. No systemic effects identified up to and including 25 mg/ kg/ day ( HDT).

Dermal LOAEL= 10 mg/ kg/ day for dermal effects and irritation. Dermal NOAEL= 2.5 mg/ kg/ day Short, Intermediate, and Long Term Inhalation Oral NOAEL = 50 mg/ kg/ day Residential LOC for MOE = 3000 Occupational = 300 Developmental toxicity study in the rat LOAEL = 200 mg/ kg/ day based on clinical signs of toxicity, decreased body weight and body weight gain, and decreased food consumption.

Cancer No cancer data available for 4 t amylphenol HDT= Highest dose tested 13 b. Residential Handler i. Exposure Scenarios, Data and Assumptions Residential exposure may occur during application of 4 t amylphenol as a hard surface disinfectant ( e. g., walls, floors, tables, fixtures), to textiles ( e. g., clothing, diapers, mattresses, bedding) and to carpets. A number of assumptions, or estimates, such as adult body weight and area treated per application, are made by the Agency for residential risk assessment. Also, note that residential handlers are sometimes addressed somewhat differently than occupational handlers in that homeowners are assumed to complete all elements of an application ( mix/ load/ apply) without the use of personal protective equipment.

The quantitative exposure/ risk assessment developed for residential handlers is based on these scenarios:

( 1) mopping hard surfaces, ( 2) wiping hard surfaces, ( 3) using trigger pump equipment to treat hard surfaces and/ or textiles, and ( 4) application to air using an aerosol spray can 4 t Amylphenol products are widely used disinfectants and have a large number of use patterns that are difficult to completely capture in this assessment. As such, the Agency has selected representative scenarios for each use site that are believed to be representative of the vast majority of 4 t amylphenol uses, based on end use product application methods and use amounts.

Surrogate data are available for mopping, wiping, trigger pump spray and aerosol can application methods. Dermal and inhalation exposures were assessed for mopping and wiping using proprietary Chemical Manufacturers Association ( CMA) data ( CMA 1992, USEPA 1999). These data are based on individuals mopping floors and receiving exposure via contact with the mop or with the bucket, or using a finger pump sprayer to apply the product and then wipe the surfaces with a paper towel. Dermal and inhalation exposures were assessed for trigger pump spray and aerosol application methods using PHED Version 1.1 values found in the Residential Exposure SOPs ( U. S. EPA, 1997a, 2001). The surrogate exposure data in PHED are based on test subjects applying an aerosol insecticide to baseboards in kitchens. The dermal and inhalation exposures from these techniques have been normalized by the amount of active ingredient handled and reported as unit exposures ( UE) expressed as mg/ lb ai handled.

In addition, product label maximum application rates, related use information, and Agency standard values were used to assess residential handler exposures. For example, it was assumed that one gallon of diluted solution is used for mopping floors, while 0.5 liters ( 0.13 gallons) are used in the wiping and trigger pump spray scenario. For aerosol can spray, it was assumed that one 16 oz can of product is used in a day. The residential handler scenarios are assumed to be of short and intermediate term duration ( 1 30 days and 1 6 months) 14 ii. Residential Handler Risk Estimates Based on toxicological criteria and potential for exposure, the Agency has conducted dermal and inhalation exposure assessments. As noted previously, MOEs greater than or equal to 3,000 for the inhalation route of exposure and 1,000 for dermal exposure are considered adequately protective for the residential exposure assessment.

A summary of the residential handler exposures and risk are presented on Table 5. For residential handlers that handle products containing 4 t amylphenol and its salts, short term, and intermediate term MOEs were above the target MOEs ( i. e.,   > 1000 for dermal and > 3000 for inhalation) for all scenarios evaluated and thus, do not exceed the Agency's level of concern.

Table 5: Estimates of Exposures and Risks to Residential Handlers of 4 t Amylphenol ( Short and Intermediate Duration)

Scenario Dermal Dose ( mg/ kg/ day) Inhalation Dose ( mg/ kg/ day) Dermal MOE ( Target MOE> 1000) Inhalation MOE ( Target MOE> 3000)

( 1) Mopping 0.00128 4.25x10 5 20,000 1,200,000 ( 2) Wiping 0.00666 1.56x10 4 3,800 320,000 ( 3) Trigger Pump Spray 0.00198 2.16x10 5 13,000 2,300,000 ( 4) Aerosol Spray 0.00233 2.54x10 5 11,000 2,000,000 c. Residential Post Application i. Exposure Scenarios, Data and Assumptions Residential postapplication exposures result when bystanders ( adults and children) come in contact with 4 t amylphenol in areas where pesticide end use products have recently been applied ( e. g., treated hard surfaces/ floors), or when children incidentally ingest the pesticide residues through mouthing the treated end products/ treated articles ( i. e., hand to mouth or object to mouth contact).

For the purposes of this screening level assessment, postapplication scenarios have been developed that encompass multiple products, but still represent a high end exposure scenario for all products represented. Representative postapplication scenarios assessed include:

° contacting treated hard surfaces/ floors ( dermal and incidental oral exposure to children), ° wearing treated clothing ( dermal exposure to adults and children), ° wearing diapers treated with a trigger pump spray ( dermal exposure to children), ° mouthing treated textiles such as clothing and blankets ( incidental oral exposure to children), and 15 ° postapplication/ bystander inhalation exposures from use of disinfecting/ deodorizing products ( vapor exposure to adults and children).

Typically, most products used in a residential setting result in exposures occurring over a short term time duration ( 1   30 days). If the products are used on a routine basis ( i. e., once a week) and the active ingredient has a long indoor half life, exposures may occur over an intermediate term time duration ( 30 days   6 months). At this time, the Agency does not have residue dissipation data or reliable use pattern data, including the frequency and duration of use of antimicrobial products in the residential setting. Even though the Agency does not believe that the use patterns of many residential products result in intermediate term exposure, they are assessed to provide an upper bound estimate of exposure. The Agency does believe, however, that intermediate term exposure to children may occur in day care centers where disinfecting products are used more frequently.

A number of conservative assumptions were used in assessing postapplication risks including maximum application rate from the label. In addition quantities handled/ treated were estimated based on information from various sources, including the Draft Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, 2001) and the AD Draft Residential SOP use table. In certain cases, no standard values were available for some scenarios. Assumptions for these scenarios were based on AD estimates and could be further refined from input from affected sectors. In the absence of data, for both the textile and diaper scenarios, it was assumed that either 100% or 5% of 4 t amylphenol could transfer and be available for dermal contact. The Agency will require data to confirm the actual transfer factor of 4 t amylphenol.

No postapplication air concentration data have been submitted for 4 t amylphenol to determine potential vapor inhalation risk. Therefore, the Multi Chamber Concentration and Exposure Model ( MCCEM v1.2) was used to present a screening level estimate of the potential inhalation risk to adults and children for the air deodorizer use. MCCEM estimates average and peak indoor air concentrations of chemicals released from products or materials in houses, apartments, townhouses, or other residences. The data libraries in MCCEM contain information about residential settings. MCCEM estimates inhalation exposures to chemicals, calculated as single day doses, chronic average daily doses, or lifetime average daily doses. All dose estimates are potential doses; they do not account for actual absorption into the body.

ii. Residential Post Application Risk Estimates Based on toxicological criteria and potential for exposure, the Agency has conducted dermal, incidental oral and inhalation exposure assessments. As noted previously, MOEs greater than or equal to 3,000 for incidental oral and inhalation exposure and 1,000 for dermal exposure are considered adequately protective for the residential exposure assessment. A summary of the residential post application exposures and risk are presented on Table 6.

The child short and intermediate term dermal MOEs for contact following hard surface disinfection is above the target MOE of 1,000 for residential settings and slightly below the MOE for daycare centers. The short and intermediate term MOEs for dermal contact with 16 treated clothing is of concern for young children ( MOEs are < 1 assuming a 100% transfer factor; MOE= 17 assuming a 5% transfer factor). For adults, the dermal MOE is below the target MOE of 1,000 using a 100% transfer factor ( MOE = 140) and above the MOE using the 5% transfer factor. The dermal MOE for children wearing treated diapers is only of concern ( MOE= 59) using a transfer factor of 100%, but it not of concern when using a transfer factor of 5%. In addition, it should be noted that 4 t amylphenol caused dermal irritant effects following repeated dermal exposure, and may also be a potential dermal sensitizer.

The short and intermediate term incidental oral MOEs following hard surface disinfection are above the target MOE of 3,000 for residential settings and daycare centers, and thus are not of concern. However, the oral MOE for children mouthing treated textiles exceeds the Agency's level of concern ( MOE= 650 compared to target MOE> 3,000).

For both adults and children, the calculated inhalation MOEs are greater than the target MOE of 3,000 for inhalation exposures following use of an air deodorizer, and thus are not of concern.

Table 6: Summary of Short and Intermediate Term Residential Post Application Exposures and Risks Scenario Dose ( mg/ kg/ day) MOE ( Target MOE> 1000 dermal; > 3000 oral and inhalation) Dermal Exposure Residential Setting 0.0067 3,700 Hard surface Disinfection Daycare center 0.0267 940 Adults 0.0092 ( 5% transfer) 0.185 ( 100% transfer) 2,700 140 Treated clothing Children 1.45 ( 5% transfer) 28.9 ( 100% transfer) 17 < 1 Treated Diapers Children 0.0212 ( 5% transfer) 0.424 ( 100% transfer) 1,200 59 Incidental Oral Exposure Residential Setting 0.000817 61,000 Hard surface Disinfection Daycare center 0.00155 32,000 Treated clothing Children 650 Inhalation Exposure Adults 0.00186 27,000 Air Deodorizer Children 0.00666 7,500 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. Since no drinking water estimates 17 were developed for 4 t amylphenol, aggregate assessments include exposure to food and as a result of residential uses only.

Typically, aggregate risk assessments are conducted for acute ( 1 day), short term ( 1 30 days), intermediate term ( 1 6 months) and chronic ( 6 months to lifetime) exposures. However, acute and chronic aggregate assessments were not conducted because there are no significant impacts to drinking water sources, nor are there long term residential uses. Thus, only short and intermediate term aggregate assessments were conducted. Oral and inhalation exposure and risk estimates were combined for the aggregate risk assessment because these endpoints are based on the same toxicity study ( oral developmental study) and effects of concern ( clinical signs and changes in body weight and food consumption). Dermal exposures were not aggregated with the oral or inhalation exposures due to different toxicological endpoints for oral ( clinical signs and body weight changes), and dermal ( no systemic effects at the highest dose tested).

a. Short and Intermediate Term Aggregate Risk Aggregate short and intermediate term risk assessments are designed to provide estimates of risk likely to result from exposures to the pesticide or pesticide residues in food, water, and from residential ( or other non occupation) pesticide uses. Short and intermediateterm aggregate risks are considered together because the exposure and toxicity endpoints are identical for incidental oral and inhalation residential exposures for both durations. For children, the short and intermediate term aggregate assessment includes average dietary exposure ( food) and estimated incidental oral exposures to children from residential uses such as hard surface disinfection. In addition, inhalation exposure from postapplication of an air deodorizer use was aggregated with the oral exposures since the toxicity endpoint is the same. For adults, the aggregate assessment includes dietary ( oral) and residential inhalation exposures from wiping a hard surface disinfectant, in addition to post application inhalation exposure from the air deodorizer.

The results of the aggregate short and intermediate term risk assessments are presented in Table 7. The aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is greater than the target of 3,000. For children, the aggregate risk estimates are also above the target MOE of 3,000 and thus are not of concern. As noted previously, incidental oral exposures to treated textiles are not included in the aggregate assessment because the oral MOE is already of concern.

A dermal aggregate assessment was not conducted because the toxicity effects for the dermal exposure route are not the same as the oral/ inhalation exposure route. However, as shown previously on Table 6, short and intermediate dermal risks are already of concern for residents for the treated textile and diaper use. 18 Table 7. Summary of Short and Intermediate Term Aggregate Risk Estimates Exposure Scenario Dose ( mg/ kg/ day) Total MOE ( b) ( Target MOE> 3000 Oral Exposure Dietary Exposure Hard Surface Disinfection   Daycare Center Child 0.0072 0.00155 Adult 0.0018( a) NA Child 6940 ( c) 32,000 Adult 28,000 ( c) NA Inhalation Exposure Handler of hard surface Disinfectant   wiping NA 0.000156 NA 320,000 Air Deodorizer 0.00666 0.00186 7,500 27,000 Total Aggregate Dose & MOE 0.0154 0.00316 3,240 13,000 NA: Not Applicable. ( a): Chronic Dietary Exposure for Females ( 13 50 years). ( b): MOE = NOAEL ( mg/ kg/ day) / potential dose rate ( mg/ kg/ day) [ Where short & intermediate term oral NOAEL = 50. ( c): Risk estimates are equivalent to percent of the PAD of 42% for child and 10.6% for adults.

b. Long Term Aggregate Risk A long term ( or chronic) aggregate assessment was not undertaken because the only long term residential use ( diaper use) results in dermal exposure, which has a different toxicological effect than the chronic dietary oral exposure.

8. Occupational Exposure and Risk Workers can be exposed to a pesticide through mixing, loading, and/ or applying a pesticide, or re entering treated sites. Occupational handlers of 4 t amylphenol include workers in a variety of occupational settings. Additionally, postapplication exposures are likely to occur in these settings. The representative scenarios selected for assessment were evaluated using maximum application rates as recommended on the product labels for 4 t amylphenol.

Occupational risk is assessed for exposure at the time of application ( termed " handler" exposure) and is assessed for exposure following application, or post application 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 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 4 tamylphenol MOEs greater than 100 for dermal exposures and 300 for inhalation exposures are not of concern to the Agency. For workers entering a treated site, MOEs are calculated for each day after application to determine the minimum length of time required before workers can safely re enter. 19 For more information on the assumptions and calculations of 4 t amylphenol ` s potential risk to workers, see the Occupational Exposure Assessment ( Section 8.0) in the " AD Risk Assessment for the Reregistration Eligibility Decision ( RED) Document"( Revised)," dated September, 2005. 3 a. Occupational Toxicity Table 4 provides a listing of the toxicological endpoints used in the occupational risk assessment for 4 t amylphenol.

b. Occupational Handler Exposure Potential occupational handler exposure can occur at various use sites, including agricultural premises, food handling, commercial/ institutional/ industrial premises, and medical premises. MOEs are: > 100 for dermal exposure and; > 300 for inhalation exposure. Only the high pressure spray in the agricultural use scenario was evaluated using gloved data.

The Agency has determined that there is potential for dermal and inhalation worker exposure to 4 t amylphenol at various use sites including agricultural premises, food handling, commercial/ institutional/ industrial premises, and medical premises. To assess handler risks, the Agency used surrogate unit exposure data from both proprietary Chemical Manufacturers ( CMA) antimicrobial exposure study and the Pesticide Handlers Exposure Database ( PHED).

c. Occupational Handler Risk Summary For the occupational handler dermal and inhalation risk assessment, the short and intermediate term risks calculated at baseline exposure ( no gloves and no respirators) were above target MOEs for all scenarios ( i. e., dermal MOEs were > 100 and inhalation MOEs were > 300). Note, however, that the high pressure spray application method in the agricultural use site category was assessed using gloved data. A summary of the results of the occupational handler assessment is provided in Table 8. 20 Table 8: Short, Intermediate Term Risks for Occupational Handlers MOE Exposure Scenario Method of Application Application Rate ( lb ai/ gallon) Quantity Handled/ Treated per day ( gallons) Baseline Dermal ( a) ( Target MOE> 100) PPE Gloves Dermal ( b) ( Target MOE> 100) Baseline Inhalation ( Target MOE> 300) Agricultural Premises and Equipment Low Pressure Handwand 10 270 No Data 150,000 High Pressure Handwand 40 No Data 5,100 210,000 Mopping 2 3,600 No Data 220,000 Wiping 0.26 690 No Data 59,000 Application to hard surfaces Trigger Pump Spray 0.0034 0.26 10,000 24,000 3,000,000 Fogger Liquid Pour of soluble concentrate 0.163 lb ai/ gal/ 6,000 ft2 15,000 ft2 120 No Data 4,500 Food Handling Low Pressure Handwand 2 1,800 No Data 1,000,000 Mopping 2 4,900 No Data 290,000 Wiping 0.26 940 No Data 80,000 Application to indoor hard surfaces Trigger Pump Spray 0.0025 0.26 7,300 17,000 2,100,000 Commercial/ Institutional Premises Low Pressure Handwand 2 920 No Data 510,000 Mopping 2 2,400 No Data 150,000 Wiping 0.26 470 No Data 40,000 Application to indoor hard surfaces Trigger Pump Spray 0.005 0.26 7,100 17,000 2,100,000 Air Deodorization Aerosol Spray 0.074% ai by weight 3 16 oz cans 4,100 9,700 1.200,000 Medical Premises and Equipment Low Pressure Handwand 2 920 No Data 510,000 Mopping 45 110 No Data 6,500 Wiping 0.26 470 No Data 40,000 Application to indoor hard surfaces Trigger Pump Spray 0.005 0.26 7,100 17,000 2,100,000 Air Deodorization Aerosol Spray 0.074% ai by weight 3 16 oz cans 4,100 9,700 1,200,000 ( a) Baseline Dermal: Long sleeve shirt, long pants, no gloves. ( b) PPE Dermal with gloves: baseline dermal plus chemical resistant gloves. 21 d. Occupational Post application Risk Summary For most of the occupational scenarios, postapplication dermal exposure is not expected to occur or is expected to be negligible based on the application rates and chemical properties of the chemical. Postapplication/ bystander inhalation exposures, however, were assessed for entry into a building after a fogging application. The representative building selected was a poultry barn. The Agency used the MCCEM ( Multi Chamber Concentration and Exposure Model) to estimate postapplication/ bystander exposures. The calculated inhalation MOEs were above the target MOE of 300 for all fogging postapplication scenarios with the exception of the scenario for 8 hr exposure to the product with a 2 hr reentry interval ( MOE = 86).

The Agency does not believe that any mitigation is necessary to address the postapplication scenario with a 2 hr reentry interval at this time. The risk estimate was calculated using the Agency's standard assumptions for air exchange rates. The Agency believes that in the case of animal barns and facilities this assumption in very conservative given the relatively high air exchange rates for such facilities.

e. Human Incident Data There are some reported incidents associated with exposure to end use products containing 4 t amylphenol. Dermal, ocular and inhalation are the primary routes of exposure. Most of the incidents are related to irritation reaction. The most common symptoms reported for cases of inhalation exposure were respiratory irritation/ burning, irritation to mouth/ throat/ nose, coughing/ choking, shortness of breath, dizziness, flu like symptoms, and headache. Eye pains, burning of eyes, conjunctivivitis, blurring vision, and acute inflammation have been reported in ocular incidents. Neurological effects, such as dizziness, headache and blurred vision also have been reported.

B. Environmental Risk Assessment A summary of the Agency's environmental risk assessment is presented below. The following risk characterization is intended to describe the magnitude of the estimated environmental risks for 4 t amylphenol use sites and any associated uncertainties. A detailed ecological hazard and environmental risk assessment for 4 t amylphenol and its salts is presented in " Ecological Hazard and Environmental Risk Assessment for 4 tert amylphenol and salts to be included in the RED", September 2005. A brief summary is presented below.

1. Environmental Fate and Transport The environmental fate assessment for 4 t amylphenol and its potassium and sodium salts is based on US EPA =

s Estimation Programs Interface ( EPI) Suite. EPI Suite provides estimations of physical/ chemical properties and environmental fate properties.

4 t Amylphenol may be bioaccumlative ( log KOW 3.91) and is likely to pose a concern for aquatic organisms. It is expected to have moderate to slight mobility in soils based upon the estimated Koc value of 3799. Estimated value for biodegradation probability indicates that it 22 may biodegrade linearly within days in aquatic medium. However, ultimate biodegradation ( mineralization) may take months. It is volatile and may vaporize into the atmosphere. The estimated half life in the air for 4 t amylphenol is about three hours which indicates that it is not persistent in air. Because of the possibility of biodegradation in water and soils, it is not likely to contaminate surface and ground waters.

4 t Amylphenol, potassium salt, is not likely to be bioaccumlative ( log KOW 1.23) and may not pose a concern for bioconcentration in aquatic organisms. It may be expected to have moderate to slight mobility in soils as its estimated Koc value is 3799. Estimated probability of biodegradation of 4 t amylphenol, potassium salt, in soils and water indicates that it is likely to biodegrade within days to weeks. Therefore, it may be unlikely that soil and water contamination would take place. It has low volatility and its estimated half life in air is about 4.68 hours and is not likely to be persistent in air.

4 t Amylphenol, sodium salt, is not likely to be bioaccumlative ( log KOW is 1.23) and may not pose a concern for bioconcentration in aquatic organisms. It may be expected to have moderate to slight mobility in soils as its estimated Koc value is the same as the parent molecule, 4 t amylphenol. Probability for sodium 4 t amylphenate biodegradation is the same as the parent molecule, 4 t amylphenol. Hence, it is not likely to persist in soils and water, and surface and ground water contamination is not likely to occur. It has low volatility and its estimated half life in air is about 4.68 hours and is not likely to be persistent in air.

2. Ecological Risk Guideline ecological effects data has not submitted for 4 t amylphenol. The only data that was available was found in the peer reviewed literature. None of these studies met current guideline requirements and therefore, could not be used in a risk assessment. There is a concern about the possibility of endocrine disruption in fish, since 4 t amylphenol is considered an ecoestrogen. This was documented in several studies on carp ( Cyprimus carpio). However, since this chemical is restricted to indoor uses only, the possibility for exposure to fish to 4 tamylphenol would be limited. The limited exposure resulting from indoor uses of 4 tamylphenol and its salts is not anticipated to cause adverse effects to terrestrial or aquatic organisms.

The acute toxicity data for 4 t amylphenol are summarized on Table 9. As shown in Table 9, acute toxicity for freshwater fish ranged from 2.50 mg/ L to 16 mg/ L in the fathead minnow. The first study was conducted using criteria similar to OPP/ OPPTS guidelines and would have more weight than the second study which did not provide any information on how the study was conducted. Therefore, the data indicates that 4 t amylphenol is moderately toxic to coldwater species, such as the fathead minnow. The fathead minnow is considered to be less sensitive than the bluegill. Also shown in Table 9, acute toxicity to shrimp was LC50 = 1.7 mg/ L. This indicated that 4 t amylphenol was moderately toxic to shrimp. The study does not meet current guideline requirements. 23 Table 9. Acute Toxicity of 4 t amylphenol and salts Organism Results  LC50 ( mg/ L) ( 95% Confidence Limit) Toxicity Category Comments Reference Freshwater Fish Fathead minnow ( Pimephales promelas) 2.50 ( 1.87  3.34) moderatel y toxic  96h test duration;  flow through bioassay  caused necrosis in fish Holcombe, G W et al. 1984 Environ Pollut ser A Ecol Biol 35: 367 81 Fathead minnow ( Pimephales promelas) 16 Slightly toxic  No information available on the test parameters Russon, C L et al. 1997 Environ. Toxicol. Chem 16: 948 Marine/ Estuarine Invertebrates Shrimp ( Crangon septemspinosa) 96h LC50 = 1.7 mg/ L Moderatel y toxic  96h test duration;  aerated gently and changed at 49 hours McLeese, D W 1981 Chemosphere 10( 7): 723 3. Endocrine Effects in Fish As mentioned above, potential endocrine effects for 4 t amylphenol have been identified. Examples of the impacts of 4 t amylphenol affecting the reproductive processes of carp have been reported in the peer reported literature. Since the use pattern for this chemical is restricted to indoor uses, exposure to fish, such as carp, should be limited. Therefore, no additional testing for endocrine disruption effects on fish is necessary. 24 Table 10: Examples of 4 t amylphenol Affecting the Endocrine System in Fish Organism Results Toxicity Category Comments Reference Male common carp ( Cyprinus carpio) caused formation of oviducts in male fish and reduced the number of primordial germ cells in gonads identified as an ecoestrogen  test concentration 0.14 mg/ L  exposed embryos and fingerlings at various ages Gimeno et al. 1997 Environ Sci Technol 31( 10): 2884 2890.

Male common carp ( Cyprinus carpio) 30 day EC50 for oviduct formation = 63 ug/ L NOEC for oviduct formation = < 36 ug/ L primordial germ cells lower in treated fish NOEC for vitellogenin induction = 90 256 ug/ L identified as causing endocrine disruption effects  120 male carp tested  nominal concentrations of 100, 320, & 1000 ug/ L were tested  160 day test duration  intermittent flow through system Gimeno, S. et al. 1998a Aquatic Toxicology ( Amsterdam) 43: 77 92.

Cultured hepatocytes from geneticallyuniform all male, F1 hybrid progenies of common carp ( Cyprinus capio) vitellogenin induction in carp hepatocytes with LOEC ranging from 5 50 uM, cytotoxic at 100uM identified as causing endocrine disruption effects  six month old hepatocytes with fully mature testes containing mature sperm Smeets, J. M. et al. 1999. Toxicol. Sci. 50( 2): 206 213.

Male common carp ( Cyprinus carpio) elevated levels of vitellogenin, inhibition of spermatogenesis, disappearance of spermatozoa and spermatogenic cysts, reduced diameter of seminiferous lobules, reduced spermatocrit values and early appearance of ovotestes LOAEL= 0.032 mg/ L identified as causing endocrine disruption effects and no mortality or growth effects  3 month test duration  nominal concentrations of 32, 100, 320 and 1000 ug/ L were tested Gimeno et al. 1998b Aquatic Toxicology ( Amsterdam) 43: 93 109.

4. Listed Species Consideration 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 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 25 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 form the indoor uses of 4 t amylphenol , 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 4 t Amylphenol end use products ( EPs) may also contain other registered pesticides. Although the Agency is not proposing any mitigation measures for products containing 4 tamylphenol 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. 26 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 4 t amylphenol and its salts ( potassium and sodium) as active ingredients. 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 4 t amylphenol and salts,

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 ingredients 4 t amylphenol. Based on a review of these data and on public comments on the Agency's assessments for the active ingredients 4 t amylphenol and its salts ( potassium and sodium), the Agency has sufficient information on the human health and ecological effects of 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 products containing 4 t amylphenol and its salts are eligible for reregistration provided that: ( i) current data gaps and confirmatory data needs are addressed; ( ii) the risk mitigation measures outlined in this document are adopted; and ( iii) label amendments are made to reflect these measures. Label changes are described in Section V. Appendix A summarizes the uses of 4 t amylphenol and salts 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 4 t amylphenol and salts, 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 4 t amylphenol and salts, the Agency has determined that 4 tamylphenol and salts products, unless labeled and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this document, the Agency may take regulatory action to address the risk concerns from the use of 4 t amylphenol and salts. If all changes outlined in this document are incorporated into the product labels, then all current risks for 4 t amylphenol and salts ( potassium and sodium) 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 decisions for 4 t amylphenol. During the public comment period on the risk assessments, which closed on September 19, 2005, the Agency received comments from the Clariant Corporation regarding risk assessment assumptions and endocrine disruption potential and from a private citizen concerned about the diaper use of this chemical. These comments in their entirety are available in the public docket, http:// docket. epa. gov/ edkpub/ index. jsp, ( OPP 2005 0181). 27 C. Regulatory Position 1. Food Quality Protection Act ( FQPA) Considerations a. " Risk Cup" Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with 4 t amylphenol. The Agency has concluded that the tolerance exemption for 4 tamylphenol meets the FQPA safety standards and that the risk from dietary ( food sources only) exposure is within the " risk cup." An aggregate assessment was conducted for exposures through food, drinking water and residential exposure. The Agency has determined that the human health risks from these combined exposures are within acceptable levels provided that the mitigation contained in this document is implemented. 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, water and residential exposures.

b. Determination of Safety to U. S. Population As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with 4 t amylphenol and its salts ( potassium and salts). The Agency has determined that the established tolerance exemption for 4 t amylphenol and its salts with amendments and changes as specified in this document, 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 reregistered, labeled uses of 4 t amylphenol and salts. In reaching this conclusion, the Agency has considered all available information on the toxicity, use practices and exposure scenarios, and the environmental behavior of 4 t amylphenol and its salts. Both the acute dietary ( food alone) and chronic dietary risks from 4 t amylphenol are not of concern. 4 t Amylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. Thus, a drinking water assessment was not conducted.

Short and intermediate term aggregate risk assessments were conducted for 4 tamylphenol The aggregate oral and inhalation risks are not of concern for adults, as the total aggregate MOE is greater than the target of 3,000. For children, the aggregate risk estimates are also above the target MOE of 3,000 and thus are not of concern. As noted previously, incidental oral exposures to treated textiles are not included in the aggregate assessment because the oral MOE is already of concern.

A dermal aggregate assessment was not conducted because the toxicity effects for the dermal exposure route are not the same as the oral/ inhalation exposure route. However, as shown previously on Table 6, short and intermediate dermal risks are already of concern for the treated textile and diaper uses. 28 c. Determination of Safety to Infants and Children EPA has determined that the established tolerance exemption for 4 t amylphenol, with amendments and changes as specified in this document, meets 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 dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of 4 t amylphenol residues in this population subgroup.

A 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 4 t amylphenol 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 retained ( i. e., remains 10X) for 4 t amylphenol based on a lack of guideline studies, qualitative evidence of sensitivity in the developmental toxicity study, and the suggestive evidence in the open literature of possible endocrine effects.

The toxicology data base is not complete with respect to assessing that increased susceptibility to infants and children as required by FQPA for 4 t amylphenol. The rat prenatal developmental study showed no quantitative evidence of increased susceptibility ( i. e., developmental NOAELs/ LOAELs were higher than those for maternal effects). However, there was qualitative evidence of increased susceptibility ( i. e., fetal effects ( skeletal abnormalities, decreased body weight gain) were considered to be more severe than the maternal toxicity ( reversible clinical signs) observed at the same dose level). In addition, there is an absence of developmental toxicity data in the rabbit and an absence of reproductive toxicity data.

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). 29 When the appropriate screening and/ or testing protocols being considered under the EDSP have been developed, 4 t amylphenol may be subject to additional screening and/ or testing to better characterize effects related to endocrine disruption.

e. Cumulative Risks Risks summarized in this document are those that result only from the use of 4 tamylphenol and salts. 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 4 t amylphenol. 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 4 t amylphenol ( also known as phenol, 4 1,1 dimethylpropyl) ( CAS No. 80 46 6) has a tolerance exception in 40CFR 180.940 ( c) as a food contact sanitizer for use in food processing equipment and utensils with a not to exceed limit of 80 ppm.

a. Tolerances Currently Listed Under 40 CFR § 180.940( c) and Tolerance Reassessment Table 11. Tolerance Reassessment Summary for 4 t amylphenol Tolerance Exemption Listed Under 40 CFR § 180.940 ( c)

Use Site Current Limit ( ppm) Tolerance Reassessment ( ppm) Correct Definition/ Comment Food processing equipment and utensils 80 540 When ready for use, the end use concentration is not to exceed 540 ppm.

b. Codex Harmonization Currently there are no Codex MRLs established for 4 t amylphenol. 30 D. Regulatory Rationale The Agency has determined that 4 t amylphenol is eligible for reregistration provided that additional required data confirm this decision and that the risk mitigation measures outlined in this document are adopted, and label amendments are made to reflect these measures.

The following is a summary of the rationale for managing risks associated with the use of 4 t amylphenol. 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 For all supported uses, the acute and chronic dietary exposure estimates are below the Agency's level of concern. Therefore, no risk mitigation measures are required to address exposure to 4 t amylphenol residues in food. Residue data are required to confirm the 10% transfer assumption used in the risk assessment.

b. Drinking Water Risk Mitigation 4 t Amylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. Thus, a drinking water assessment was not conducted. Therefore, no risk mitigation measures are required to address 4 t amylphenol exposure from drinking water.

c. Residential Risk Mitigation Residential risks from handler and post application exposure were calculated for shortand intermediate term dermal, inhalation and incidental oral exposures. All exposure and risk estimates for residential handler scenarios are below the Agency's level of concern. Therefore, no risk mitigation measures are required for these handler scenarios.

Risks of concern have been identified for several post application exposure scenarios including children's dermal exposure to treated clothing and treated diapers and children's incidental oral exposure to treated clothing. The Agency believes that adding clear instructions for washing and rinsing textile items will result in the adequate removal of residues from the treated items and address the Agency's concerns for this scenario. The MOE for dermal exposure to children to treated surfaces in daycare centers slightly exceeds the Agency's level of concern ( MOE = 940 with a target MOE of 1,000). However, the Agency believes actual exposure from this pathway to not exceed its level of concern when taking into account the conservative nature of the risk estimate which is likely to overestimate potential exposures. 31 In summary, to reduce residential exposure, the Agency has determined that the following mitigation and label changes for specific scenarios are appropriate and required for reregistration eligibility:

 Delete all diaper uses  Delete all use on non laundered textiles\ items including mattresses, helmets, headgear, headphones, face gear, and mouthpieces.  All labels with laundered textile uses must have directions that indicate that items must be treated prior to washing and rinsing.

d. Occupational Risk Mitigation i. Handler Exposure Occupational risks from handler and applicator exposures were calculated for short term and intermediate term dermal and inhalation exposures. All exposure and risk estimates for occupational handler scenarios are below the Agency's level of concern. Therefore, no risk mitigation measures are required for these handler scenarios.

ii. Post Application Risk Mitigation Post application exposure to re entry workers is possible because 4 t amylphenol can be applied as a fogging application to animal buildings. The Agency used the MCCEM ( Multi Chamber Concentration and Exposure Model) to estimate postapplication/ bystander exposures. The calculated inhalation MOEs were above the target MOE of 300 for all fogging postapplication scenarios with the exception of the scenario for 8 hr exposure to the product with a 2 hr reentry interval ( MOE = 86).

The Agency does not believe that any mitigation is necessary to address the postapplication scenario with a 2 hr reentry interval at this time. The risk estimate was calculated using the Agency's standard assumptions for air exchange rates. The Agency believes that in the case of animal barns and facilities this assumption is very conservative given the relatively high air exchange rates for such facilities.

2. Environmental Risk Management As the uses of 4 t amylphenol considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur, no risk mitigation measures are required to address environmental exposure to 4 t amylphenol.

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 4 t amylphenol. For the specific labeling statements and a list of outstanding data, refer to Section V of this RED document. 32 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 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 of 4 t amylphenol, 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 4 t Amylphenol end use products ( EPs) may also contain other registered pesticides. Although the Agency is not proposing any mitigation measures for products containing 4 tamylphenol specific to federally listed threatened and endangered species, the Agency needs to address potential risks from other end use products. Therefore, the Agency requires that users adopt all threatened and endangered species risk mitigation measures for all active ingredients in 33 the product. If a product contains multiple active ingredients with conflicting threatened and endangered species risk mitigation measures, the more stringent measure( s) should be adopted. 34 V. What Registrants Need to Do The Agency has determined that 4 t amylphenol is eligible for reregistration provided that: ( i) additional data that the Agency intends to require confirm this decision; and ( ii) the risk mitigation measures outlined in this document are adopted, and ( iii) label amendments are made to reflect these measures. To implement the risk mitigation measures, the registrants must amend their product labeling to incorporate the label statements 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 4 t amylphenol 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 Killian Swift at ( 703) 308 6346 with questions regarding generic reregistration.

By US mail: By express or courier service: Document Processing Desk ( DCI/ SRRD) Document Processing Desk ( DCI/ SRRD) Killian Swift Killian Swift 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 35 For end use products containing the active ingredient 4 t amylphenol, 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 13 of this document;

4. a completed form certifying compliance with data compensation requirements ( EPA Form 8570 34); and 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 36 A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic database supporting the reregistration of 4 t amylphenol 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 4 t amylphenol. The requirements would consist of an acute toxicity testing battery, subchronic toxicity studies in the rodent, a developmental toxicity study in the rat, and a mutagenicity testing battery. The developmental toxicity study in the rat, mutagenicity testing battery, the acute oral toxicity and the acute dermal irritation data requirements has been fulfilled for 4 t amylphenol. 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 studies in a non rodent which would become data requirements if warranted by the Agency's evaluation of the Tier 1 data. A 2 generation reproduction study and a subchronic toxicity study in a non rodent are being held in reserve for 4 t amylphenol.

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.

As mentioned earlier, the Agency assumed that food can contact 2000 cm2 of treated surfaces, and that 10% of the pesticide migrates to food based on the Agency Residential SOPs in its dietary risk assessment. The use of the 10% transfer rate instead of the use of a 100% transfer rate that is used in the FDA Sanitizer Solution Guidelines requires the submission of confirmatory data to establish the reliability of the use of the10% transfer rate.

The Agency is also holding in reserve a developmental toxicity study in rabbits based on the potential endocrine disruption effects of this chemical. The need for this study will be determined following the Agency's review of the 90 day oral study in rodents.

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 37 ( 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.

A 28 day rat inhalation study for hazard considerations because 4 t amylphenol is an air deodorizer was considered, however, the Agency does not believe this study is necessary because the MOEs are sufficiently high for this use, and thus not of concern. In addition, the Agency believes the repeat dermal toxicity study with end use formulation product, and confirmatory residue migration data are not necessary because the diaper and textile use are no longer eligible for registration.

Table 12. Confirmatory Data Requirements for Reregistration Guideline Study Name New OPPTS Guideline No. Old Guideline No.

90 day Oral Subchronic in Rats ( including neurotoxicity and endocrine endpoints) 870 3100 82 1 Acute Dermal Toxicity 870.1200 81 2 Acute Inhalation Toxicity 870.1300 81 3 Acute Eye Irritation 870.2400 81 4 Skin Sensitization 870.2600 81 6 Dermal Indoor Exposure 875.1200, 875.1600 233 and 236 Inhalation Indoor Exposure 875.1400, 875.1600 234 and 236 Descriptions of Human Activity 875.2800 133 1 Avian acute oral toxicity 850.2100 71 1 Freshwater fish acute toxicity 850.1075 72 1 Freshwater invertebrate acute toxicity 850.1010 72 2 Dietary Residues in Food from Treating Countertops with 4 t amylphenol ( FDA Wipe Study Methodology) ( FDA, 2003a and 2003b) Non Guideline Non Guideline Studies Held in Reserve 2 Generation Reproduction 870.3800 83 4 90 day Oral Subchronic in Non Rodents 870 3150 82 1 Developmental Toxicity in Rabbits 870.3700b 83 3b 38 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 follow this RED.

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.

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. 39 a. Label Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended.

Table 13. Labeling Changes Summary Table Summary of Labeling Changes for 4 t Amylphenol and its Salts Description Amended Labeling Language Placement on Label Delete use on diapers Use Directions Delete all use on nonlaundered textiles\ items including mattresses, helmets,

headgear, headphones,

facegear, and mouthpieces. Use Directions Laundry Use Clarify language to ensure use requires washing and rinsing prior to wearing clothing Use Directions 40 41 VI. APPENDICES 42 43 Appendix A: Use Patterns Eligible for Reregistration 4 T Amylphenol Use Site Formulation Method of Application Application Rate/ No. of applications Use Limitations ( 1) Agricultural premises and equipment Soluble concentrate:

Reg. 211 36 Mop, cloth,

sponge or hand trigger sprayer 1 oz per gallon of water 1: 128 dilution Thoroughly wet for 10 minutes allow to air dry Use as a premises spray, do not apply to the crop, compost, or casing.

Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Mushroom houses empty premises/ equipment Soluble concentrate:

Reg. 1043 26 Reg. 211 25 Reg. 65020 7 Mop, cloth,

sponge or hand trigger sprayer 1/ 2 oz per gallon of water 1: 256 dilution Thoroughly wet for 10 minutes allow to air dry Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Hard, non porous, non food contact surfaces Soluble concentrate:

Reg. 211 36 Reg. 49403 6 Reg. 1043 118 Reg. 11725 9 Mop, cloth,

sponge or hand trigger sprayer 1 oz per gallon of water 1: 128 dilution Thoroughly wet for 10 Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected 44 Use Site Formulation Method of Application Application Rate/ No. of applications Use Limitations minutes allow to air dry handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Soluble concentrate:

Reg. 211 36 Reg. 49403 6 Reg. 1043 118 Reg. 66171 1 Reg. 11725 9 Mop, cloth,

sponge or hand trigger sprayer 1 oz per gallon of water 1: 128 dilution Thoroughly wet for 10 minutes allow to air dry ** Shoe bath sanitizer containing one inch of freshly made disinfectant should be placed at all entrances Do not use in milking stalls. Milking parlors, or milk houses. Do not apply to crop, soil or growing media in which a crop grows or will be growing Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Agricultural/ farm equipment/ shoe baths Agricultural/ farm equipment/ shoe baths ( continued) Soluble concentrate:

Reg. 11725 8 Reg. 1043 91 Reg. 11725 7 Reg. 1043 26 Reg. 211 25 Fogger ( wet misting) ½ oz per gallon of water 1: 256 dilution Set the automatic timer on the fogger for 6 minutes for 1000cu. ft and leave the room. Allow at least 2 hours before entering a room that has been fogged Treated food contact surfaces must be thoroughly rinsed with potable water prior to use. Do not apply in a way that will contact workers or any other persons, either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/ water) 45 Use Site Formulation Method of Application Application Rate/ No. of applications Use Limitations Soluble concentrate:

Reg. 66171 1 Reg. 11725 7 Reg. 1043 26 Reg. 211 25 Reg. 65020 7 Reg. 3862 180 Mop, cloth,

sponge or hand trigger sprayer 1/ 2 oz per gallon of water 1: 256 dilution Thoroughly wet for 10 minutes allow to air dry ** Shoe bath sanitizer containing one inch of freshly made disinfectant should be placed at all entrances Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

( 2) Food handling/ storage establishments premises and equipment Hard, non porous, non food contact surfaces Hard, non porous, non food contact surfaces ( continued) Ready to use solution:

Reg. 1270 237 Reg. 1008 105 Spray To disinfect: Thoroughly wet ( saturate) all surfaces for 10 minutes. Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water) 46 Use Site Formulation Method of Application Application Rate/ No. of applications Use Limitations Soluble concentrate:

Reg. 1043 92 Reg. 1043 91 Reg. 11725 7 Mop, cloth,

sponge or hand trigger sprayer 1/ 2 oz per gallon of water 1: 256 dilution Thoroughly wet for 10 minutes allow to air dry Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Ready to use solution:

Reg. 10088 105 Reg. 1270 237 Spray To disinfect: Thoroughly wet ( saturate) all surfaces for 10 minutes. Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Meat processing plant premises ( nonfood) Soluble concentrate:

Reg. 11725 7 Mop, cloth,

sponge or hand trigger sprayer 1/ 2 oz per gallon of water 1: 256 dilution Thoroughly wet for 10 minutes allow to air dry Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water) 47 Use Site Formulation Method of Application Application Rate/ No. of applications Use Limitations Ready to use solution:

Reg. 10088 105 Reg. 1270 237 Spray To disinfect: Thoroughly wet ( saturate) all surfaces for 10 minutes. Following application as a spray, do not enter or allow others to enter the treated area until sprays have dries. Do not apply in a way that will contact workers or any other persons,

either directly or through drift. Only protected handlers may be in the area during the application. Do not contaminate other materials ( including foods/ drinks/ feeds/

water)

Poultry processing plant premises ( nonfood)