/^Z^\ Status of Conditional trfj k f\ I 1 Registrations under FIFRA sec. 3(c)(7)(C) from 2000 to 2015 XJt PRO^^ May 2015 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Ammonium Carbamate AD 2/24/2014 Green Algae Toxicity Study 11/24/2014 49496201 In Review 10/24/2014 Bethoxazin AD 6/6/2006 Fish Acute Toxicity Test, Freshwater and Marine 9/30/2006 46939003 Cancelled 9/20/2006 Cancelled July 2011 Daphnid Chronic Toxicity Test 9/30/2006 46969001 Cancelled 9/20/2006 90-Day Inhalation Toxicity 4/30/2007 Waiver Requested Cancelled N/A Seedlinq Emerqence, Tier II 6/1/2008 47675201 Satisfied 2/13/2009 Veqetative Viqor, Tier II 6/1/2008 47675201 Satisfied 2/13/2009 Duckweed Study 6/1/2008 47675202 Satisfied 2/13/2009 Alqal Toxicity, Tiers I and II 6/1/2008 47675203 Satisfied 2/13/2009 Boric Acid AD 9/27/2007 Fish Acute Toxicity Test, Freshwater and Marine 9/28/2008 47425202 Satisfied 5/15/2008 Mysid Acute Toxicity Test 9/28/2008 47425204 Satisfied 5/15/2008 Acute Embryo larvae 9/28/2008 47425201 Satisfied 5/15/2008 Green Alaqe Study 6/1/2008 47425203 Satisfied 5/15/2008 Whole Sediment Freshwater 9/28/2008 Waiver Requested Waived N/A Whole Sediment Marine 9/28/2008 Waiver Requested Waived N/A Leachinq Study 11/28/2008 Waiver Requested Waived N/A Ready Biodeqradability 3/6/2010 48012102 Satisfied 3/5/2010 Sediment and Soil Adsorption/Desorption Isotherm 3/6/2010 48012103 Satisfied 3/5/2010 Cetyi pyridinium chloride AD 3/5/2009 Activated Sludge Sorption Isotherm 3/6/2010 48012104 In Review 3/5/2010 2010 Studies Not Acceptable. New data submitted in October 2013,under reivew as of April 2014 Aerobic Deqradation 3/6/2010 48012105 Satisfied 3/5/2010 Alqal Toxicity, Tiers I and II 3/6/2010 48012106 Satisfied 3/5/2010 Activated Sludqe Sorption Isotherm 3/6/2010 48012107 Satisfied 3/5/2010 Bacterial Reverse Mutation Test 3/6/2010 48012108 Satisfied 3/5/2010 Mouse Carcinoqenicity Study 10/31/2009 47667001 Satisfied 2/9/2009 Skin Sensitization 10/31/2007 Waiver Requested Waived N/A Hydrolysis 4/31/2007 47348101 Satisfied 2/15/2008 Copper Carbonate, basic (Polymeric Betaine) Aerobic Soil Metabolism 10/31/2007 47757601 Satisfied 5/22/2009 Avian Acute Oral 10/31/2007 46768502 Satisfied 2/24/2006 AD 10/31/2006 Fish Acute Toxicity Test, Freshwater and Marine 10/31/2007 Waiver Requested Waived N/A Aquatic Invetebrate Acute Toxicity, Test, Freshhwater Daphnids 10/31/2007 Waiver Requested Waived N/A Other (fixation) 4/31/2007 47484102,47484101, 47497001 Satisfied 7/22/2008 and 8/5/2208 21/28-Day Dermal Toxicity 5/14/2004 47045101 Satisfied 2/1/2007 Surface residue wipe study 5/14/2004 46764002 Satisfied 2/21/2006 Fish Early-Life Staqe Toxicity Test 5/14/2004 46914401 Satisfied 8/18/2006 Fish BCF 5/14/2004 45834101 Satisfied 1/9/2003 Whole Sediment Acute Toxicity Invertebrates, Freshwater 5/14/2004 45821701 Satisfied 12/20/2002 DDAC AD 5/14/2003 Whole Sediment Acute Toxicity Invertebrates, Marine 5/14/2004 45821702 Satisfied 12/20/2002 Honey bee toxicity study 5/14/2004 Waiver Requested Waived N/A Seedlinq Emerqence, Tier II 5/14/2004 46375401 Satisfied 10/1/2004 Veqetative Viqor, Tier II 5/14/2004 46414501 Satisfied 12/1/2004 Aquatic Plant Toxicity Test using Lemna spp. Tiers I and II 5/14/2004 46295804 Satisfied 6/16/2004 Anaerobic Aquatic Metabolism 5/14/2004 46124303 Satisfied 11/18/2003 Alqal Toxicity, Tiers I and II 5/14/2004 46295801 Satisfied 6/16/2004 Environmental monitorinq study 5/14/2004 46934201 Satisfied 9/14/2006 Seedling Emergence using rice (Oryza sativa), TEP 6/1/2008 47675201 Satisfied 2/13/2009 6/1/2015 1 of 35 ------- Chemical Divi&ion Reg Notice Date Conditional Data Reauirementfs) MRID for Studv Review Status Date Data Received Comments Tier II Vegative Vigor using rice (Oryza sativa) TEO 6/1/2008 47675201 Satisfied 2/13/2009 Lemna qibba (duckweed) usinq TEP 6/1/2008 47675202 Satisfied 2/13/2009 Algal toxicity studies using TEP Anabaena flos- aquae (blue-green cyanobacteria) Noavicula pelliculosa (freshwater diatom) Skeletonema cosatum (marine diatom) 6/1/2008 47675203, 47675204 Satisfied 2/13/2009 Fenpropimorph AD 9/27/2007 Acute estuarine/marine fish 9/28/2008 47425202 Satisfied 5/15/2008 Acute Mvsid shrimp 9/28/2008 47425204 Satisfied 5/15/2008 Acute embryo larvae usinq E. oyster 9/28/2008 47425201 Satisfied 5/15/2008 Selenastrum capricornutum (green algae) using TEP 6/1/2008 47425203 Satisfied 5/15/2008 Whole sediment acute freshwater invertabrates usinq fenpropimorphic acid 9/28/2008 47425201 Satisfied 5/15/2008 Whole sediment acute marine invertabrates usinq fenpropimorphic acid 9/28/2008 47425201 Satisfied 5/15/2008 Leachability of Wood Preservatives 11/28/2008 Waiver Requested Waived N/A Glvcolic Acid AD 71654-1 Registered conditionally but no data required No Data Required N/A N/A N/A Listeria specific bacteriophage AD 6/18/2008 Additional efficacy data (Monitoring Plan) Not specified 47242001 Satisfied 9/28/2007 Lonzabec AD 5/20/2006 Storaqe Stability /Corrosion Characteristics 12/1/2006 46309707, 46309706 Satisfied 7/8/2004 Analytical Method 12/1/2006 46309707 Satisfied 7/8/2004 Potassium Hypochlorite AD 63838-10 Registered conditionally but no data required No Data Required N/A N/A N/A Silver chloride AD 3/28/2006 Enforcement Analytical Method 6/28/2006 46914401 Satisfied 8/18/2006 Phase 1 - Product Characterization Particle Size Distribution 3/31/2012 48854401 6/6/2012 Surface Area 3/31/2012 48821601, 48957801 Satisfied 5/4/2012 and 10/25/2012 Phase 2 - Product Testing Stability 3/31/2012 Waiver Request 4878801 Satisfied 4/2/2012 Storaqe Stability 3/31/2012 48788002 Satisfied 4/2/2012 Corrosion Characteristics 3/31/2012 48788002 Satisfied 4/2/2012 UV-Vis 3/31/2012 48878801 Satisfied 6/29/2012 Solubility 3/31/2012 48788003 Satisfied 4/2/2012 Phase 3 - Release Characteristics/Exposure Dissolution Kinetics 6/28/2013 49141001 Satisfied 6/3/2013 Leachinq Test of Textile 5/31/2013 49165501 Satisfied 7/2/2013 Dermal Exposure-Indoor 3/31/2013 Waived 11/8/2012 Agency determined use of water-soluble Inhalation Exposure-Indoor 3/31/2013 Waived 11/8/2012 packaging satisfied exposure testing Attrition Test - Laundry Drying 3/31/2013 Waived Agency determined Attrition Test no longer needed based on water-soluble packaging and the results of the dissolution kinetics and textile leaching studies (10/22/2013) Phase 4 - Health Effects 90-Day Inhalation Waived No longer required based on water- soluble packaging which greatly reduces inhalation exposure. 90-Day Dermal Toxicity 6/30/2015 Pending The textile leaching study indicated that silver in the form of particulate (which likely contains AGS-20 particles) was released from surface coated textiles. Reproduction/Developmental Toxicity Screening Test Pending Required based on specific concerns for sensitive organ targets including testes and uterine lining 6/1/2015 2 of 35 ------- in vitro micronucleus (MN) assay Phase 5 - Ecoloqic Effects Avian Acute Oral Toxicity Aquatic Invertebrate Acute Toxicity, Feshwater Daphnids Fish Acute Toxicity Test, Freshwater and Marine Phase 6 - Characterization UV-Vis Particle Size Distribution Surface Area Solubility Zeta-potential Phase 7 - Health Effects 90-Day Oral Toxicity 90-Day Dermal Toxicity Modified Reproduction/Developmental Toxicity Screening Test in vitro micronucleus (MN) assay Phase 8 - Ecological Effects Modified Aquatic Food Chain Transfer 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 t R. .ii 'li.itinn Statue ID for S Date Data Chemical Division ReĢ Notice Date Review Status Pending Pending Pending Pending Pending Pending Pending Pending Pending No longer reguired. No longer reguired. No longer required. No longer reguired. Pending Required to define the potential mutagenicity of the specific product Waived for the purposes of hazard labeling because of language on the label but if nanosilver particles are found to be attached or within aquatic plant cells in the aquatic plant, Tier II study(ies), and/or found within invertebrates in the chronic whole sediment studies this study is required for a waterfowl. Protocols are required to be submitted prior to conducting the study The Agency determined a study with the most acutely sensitive aquatic animal species to silver, Daphnia magna, is required to support risk assessment and characterization based on results of the textile leaching and dissolution kinetics studies. Protocols are required to be submitted prior to conducting the study. Based on results of textile leaching study, dissolution studies, and toxicity of other nanosilvers, the Agency determined if the acute freshwater invertebrate results with AGS-20 and the nanosilver in AGS-20 demonstrate that their toxicity is significantly more toxic than the other nanosilvers used to support the risk assessment data on an acutely sensitive freshwater and an acutely sensitive saltwater fish species are required to confirm the risk assessment and characterization findings. Protocols are required to be submitted prior to conducting the study. The textile leaching study indicated that silver in the form of particulate (which likely contains AGS-20 particles) was released from surface coated textiles. No longer required because the dissolution kinetics and textile leaching studies indicated that silver nanoparticles were not released in sufficient amounts to be of concern for human health. If nanosilver particles are found to be attached or within aquatic plant cells in the aquatic plant, Tier II studies, and/or found within invertebrates in the chronic whole sediment studies this study is required. Protocols are required to be submitted prior to conducting the study. 6/1/2015 3 of 35 ------- Silver Nano Particles AD 12/1/2011 Terrestrial Plant Toxicity, Seedling Emergence Aquatic Plant Toxicity, Tier II Algal Toxicity, Tier II Measuring the Chronic Effects of Freshwater Sediment-Associated Contaminants on Chironomus dilutes Measuring the Chronic Effects of Freshwater Sediment-Associated Contaminants on Hyalella azteca 6/30/2015 6/30/2015 6/30/2015 6/30/2015 6/30/2015 \ Ļ 'i I'-'tinn Statue ID for S Cnemica Conditional Data Reauirementlsl Division ReĢ Notice Date Review Status Pending Pending Pending Pending Pending Based on results of the textile leaching study, the dissolution studies, and toxicity of other nanosilvers the Agency determined if the nanosilver in AGS-20 with the green algae, Selenastrum capricornutum, is significantly more toxic than the other nanosilvers used to support the risk assessment, a Tier II (dose response) study with the rice, Oryza sativa, with AGS-20 and the nanosilver in AGS-20 is required to confirm the findings of the risk assessment. Protocols are required to be submitted prior to conducting the study. Based on results of the textile leaching study, the dissolution studies, and toxicity of other nanosilvers the Agency determined if the nanosilver in AGS-20 with the green algae, Selenastrum capricornutum, is significantly more toxic than the other nanosilvers used to support the risk assessment, a Tier II (dose response) study with the duckweed, Lemna minor, is required to confirm the findings of the risk assessment. Protocols are required to be submitted prior to conducting the study. Based on results of the textile leaching study, the dissolution studies, and toxicity of other nanosilvers the Agency determined one Tier II (dose response) study conducted with the green algae, S. capricornutum, is required to confirm the findings of the risk assessment. If the Tier II S. capricornutum result is significantly more toxic than value used in risk assessment data on the freshwater and saltwater diatoms (Navicula pelliculosa and Skeletonema costatum) and the cyanobacterium (Anabaena flos-aqua) is also required. Based on results of the textile leaching study and the dissolution studies the Agency determined this study is required to confirm the findings of the risk assessment. The more toxic of the end use product (AGS-20) or the nanosilver from the Hyalella azteca study is the required test substance. Protocols are required to be submitted prior to conducting the study. Based on results of the textile leaching study and the dissolution studies Agency determined study is required to confirm the findings of the risk assessment. Protocols are required to be submitted prior to conducting the study. 6/1/2015 4 of 35 ------- Chemical Division Ren Notice Date Conditional Data Requirement(s) MRID for Studv Review Status Date Data Measuring the Chronic Effects of Marine and Estuarine Sediment-Associated Contaminants on Leptocheirus plumulosus 6/30/2015 Pending Based on results of the textile leaching study and the dissolution studies Agency determined study is required to confirm the findings of the risk assessment. The more toxic of the end use product (AGS- 20) or the nanosilver from the Hyalella azteca study is the required test substance. Protocols are required to be submitted prior to conducting the study. Phase 9 - Environmental Fnte Rate of Aggregation 6/30/2015 Pending Required to determine the rate at which the product aggregates or deaggregates in the aqueous medium (when the product dissolves in an aqueous medium) Activated Sludge Sorption Isotherm 6/30/2015 Pending Required to determine the effect of AGS- 20 and the nanosilver in AGS-20 on microbes present in wastewater sludge Adsorption/Desorption 6/30/2015 Pending Required to determine the rate AGS-20 and the nanosilver contained in AGS-20 binds to sediment and soils. (If AGS-20 or nanosilver in AGS-20 does not bind strongly, it will migrate into ground water with a possibly of ground water contamination or if it binds strongly it will result in benthic invertebrate exposure.) Leaching Studies (Soil Column Tests) 6/30/2015 Pending The Agency determined that the Adsorption/ Desorption (Soil) study can be conducted to provide information on both partitioning to solids and mobility in subsurface environment and therefore waives this study. Modified Activated Sludge, Respiration Inhibition Test for Sparingly Soluble Chemicals 6/30/2015 Pending Required to determine if AGS-20 and the nanosilver in AGS-20, which is not highly water soluble, has adverse effects on the microbes present in the activated sludge Tolylfluanid AD 12/30/2007 Monitoring Study 3/1/2008 48071901 Cancelled 4/22/2010 Voluntary cancellation requests for all registered tolylfluanid products were received and should post in the February FR. Trimethoxysilyl quat AD 11/22/2006 Developmental Toxicity Study (to remove production cap of 10,000lbs) 1/31/2008 47449001 Satisfied 6/17/2008 Enforcement Analytical Method 6/21/2007 47148601 Satisfied 6/7/2007 Aspergillus BPPD 6/24/2003 1. Efficacy (Texas) 6/24/2006 46859502 Satisfied 6/15/2006 flavus AF36 2. 5-batch analysis 6/24/2006 46859501 Satisfied 6/14/2006 Aspergillus flavus NRRL 21882 BPPD 5/28/2004 1. Analysis and certified limits 11/28/2006 47008702 47189202 47349302 47364501 Satisfied 12/18/2006 7/26/2007 2/19/2008 3/6/2008 2. Product identity and composition 11/28/2006 47008702 47364501 Satisfied 12/18/2006 3/6/2008 3. Storage stability 11/28/2006 47364501 47349302 Satisfied 2/19/2008 4. Efficacy Not specified 47008701 47189201 47299401 Satisfied 12/18/2006 7/26/2007 12/6/2007 6/1/2015 5 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) 6/20/2001 MRID for Studv 45206101 Review Status Date Data Comments , > - r- BPPD 6/20/2000 1. Manufacturing process (upgrade submitted study; includes 5-batch analyses and quality control to limit microbial impurities) Bacillus subtilis QST 713 Satisfied 9/11/2000 2. Freshwater fish toxicity/pathoqenicity 6/20/2001 45455202 Satisfied 7/17/2001 3. Freshwater aquatic invertebrate toxicity/pathoqenicity 6/20/2001 45455203 Satisfied 7/17/2001 4. 30-day toxicity/pathoqenicity in qrass shrimp 6/20/2001 45455204 Satisfied 7/17/2001 5. Non-tarqet insect - parasitic Hymenoptera 6/20/2001 45455205 Satisfied 7/17/2001 6. Honeybee study 6/20/2001 46172901 46172902 Satisfied 1/14/2004 7. Storaqe stability 6/20/2002 45188101 Satisfied 9/11/2000 Beauveria bassiana strain 447 BPPD 9/27/2002 5-batch analysis 6/30/2004 46480601 Satisfied 8/29/2005 Beauveria bassiana strain HF23 BPPD 12/27/06 1. 5-batch analysis 6/27/2008 47345701 Satisfied 2/14/2008 2. Certification of limits 6/27/2008 47345701 Satisfied 2/14/2008 3. Unintentional inqredients 6/27/2008 47345701 Satisfied 2/14/2008 4. Human pathoqens 6/27/2008 47345701 Satisfied 2/14/2008 5. Storaqe stability 6/27/2008 47779201 Satisfied 6/16/2009 6. Viability data 6/27/2008 47345701 Satisfied 2/14/2008 Calcium lactate BPPD 2/15/2008 Efficacy 2/15/2009 N/A Cancelled N/A Registration of product with this active ingredient was cancelled on 9/3/2010. Chenopodium ambrosoides var. BPPD 6/30/2010 1. Storaqe stability 6/30/2015 Pending Due date for submission of storage stability data extended to 6/30/2015. 2. 5-batch preliminary analysis 6/30/2011 49061001 49061002 In Review 2/21/2013 Chondrostereum purpureum BPPD 9/23/2004 5-batch analysis Not specified 46702401 Satisfied 12/5/2005 Coat Protein Gene of Plum Pox Virus BPPD 5/7/2010 Independent laboratory validation of analytical method 5/7/2011 4828401 Satisfied 11/3/2010 Coddling moth virus BPPD 6/20/2001 Cell culture study 6/30/2003 45650901 Satisfied 4/11/2002 Corn qluten meal BPPD 9/4/2002 Storaqe stability 3/4/2003 45870101 Satisfied 3/4/2003 COT102 x COT67B (Vip3Aa19 x FLCrylAb) BPPD 6/26/2008 1. Independent laboratory validation of analytical method 5/1/2009 47743201 Satisfied 5/1/2009 2. 7-14 day Daphnia or aquatic invertebrate dietary study 5/1/2009 47779101 47779102 Satisfied 6/16/2009 3. Baseline susceptibility and diagnostic concentration determinations for major cotton pests 1/31/2009 47662801 Satisfied 2/2/2009 CrylF in corn BPPD 5/18/2001 1. Soil degradation study (field) Not specified 47120701 Satisfied 5/2/2007 2. Confirmatory Monarch butterfly data Not specified 45759701 Satisfied 9/18/2002 CrylF (Event 281) and CrylAc (Event 3006) Bt in cotton1 BPPD 9/30/2004 1. Data supporting natural refuge as alternate host to Cotton Bollworm (CBW) 7/31/2005 46610301 46909901 47019301 Satisfied 8/1/2005 8/10/2006 12/29/2006 2. Baseline susceptibility data and discriminating dose of toxins for Tobacco Budworm (TBW) and CBW 9/1/2005 46938701 47223501 Satisfied 1/31/2005 9/21/2006 9/5/2007 3. Avian chronic exposure study 9/30/2008 Waiver requested Waived 4/7/2006 4. Non-target insect study (minute pirate bug) 9/30/2008 47462301 Satisified 7/1/2008 5. Soil fate/terrestrial expression studies for long range soil persistence Not specified 47214501 Satisfied 8/27/2007 Cry2Ab2 in cotton BPPD 6/14/2002 1. Heat stability study 6/30/2003 45086303 Satisfied 4/7/2000 2. Confirmatory soil degradation study 6/30/2003 45806601 Satisfied 11/25/2002 3. Avian oral toxicity 6/30/2003 45086316 45086317 Satisfied 4/7/2000 4. Ladvbeetle larval data 6/30/2003 45086311 Satisfied 4/7/2000 6/1/2015 6 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) 2/13/2005 MRID for Studv Review Status Date Data Comments 45943801 46186501 46262701 46725901 46949101 Received , > - r- BPPD 2/24/2003 1. Insect resistance management/pest biology research data ' .. i 1. . . Cry3Bb1 (Event MON 863) Satisfied 5/29/2003 2/4/2004 5/4/2004 12/12/2005 10/4/2006 2. Expression data 2/24/2005 46479902 Satisfied 2/25/2005 3. Field deqradataion studies 2/24/2005 46510301 Satisfied 3/31/2005 4. Laboratory toxicity data for 2 species of non- tarqet beetles 2/242005 46479904 46479905 Satisfied 2/25/2005 5. 3-year full-scale or semi-field studies - non- tarqet invertebrates Not specified 46262702 46262703 46394202 Satisfied 5/4/2004 11/1/2004 6. 6-week broiler dietary study Not specified 45941501 Satisfied 5/23/2003 Cry3Bb1 (Event MON 88017) BPPD 12/13/2005 1. Insect resistance management/pest biology research data Not specified 45943801 46186501 46262701 46725901 46949101 Satisfied 5/29/2003 2/4/2004 5/4/2004 12/12/2005 10/4/2006 The registration of this active ingredient required that the conditional data requirements for Cry3Bb1 (Event MON 863) must be satisfied. 2. Expression data Not specified 46479902 Satisfied 2/25/2005 3. Field deqradataion studies Not specified 46510301 Satisfied 3/31/2005 4. Laboratory toxicity data for 2 species of non- target beetles Not specified 46479904 46479905 Satisfied 2/25/2005 5. 3-year full-scale or semi-field studies - non- tarqet invertebrates Not specified 46262702 46262703 Satisfied 5/4/2004 6. 6-week broiler dietary study Not specified 45941501 Satisfied 5/23/2003 Cry34Ab1 and Cry35Ab1 (Cry34/35Ab1) BPPD 8/31/2005 1. Laboratory toxicity data for 2 species of non- tarqet beetles 8/31/2007 46714101 47436701 Satisfied 12/20/2005 6/3/2008 This registration will expire 9/30/2015. 2. 3-year full-scale field or semi-field studies - non-tarqet invertebrates 9/30/2009 47870301 Satisfied 9/28/2009 3. 3-year field degradation study 1/31/2010 47959501 Satisfied 1/21/2010 Cydia pomonella Granulosis Virus BPPD 7/17/2000 1. Manufacturing process 7/17/2002 N/A Cancelled N/A Registrations of products with this active ingredient were cancelled on 7/14/2010. 2. Analysis of Samples 7/17/2002 N/A Cancelled N/A 3. Product identity 7/17/2002 N/A Cancelled N/A 4. Certification of limits 7/17/2002 N/A Cancelled N/A 5. Acute Intraperitoneal toxicity/pathogenicity study 7/17/2002 N/A cancelled N/A eCry3.1Ab (Event 5307) BPPD 7/31/2012 1. Plant-based diagnostic assay report By 2014 49048901, 49049001 In Review 1/31/2013 Item 2 not submitted by due date. Syngenta committed to 1/2015 submission. Item 3 extension requested and granted to submission date. 2. Corn rootworm baseline susceptibility data 7/31/2014 49559102 In Review 1/30/2015 3. Data to address cross-resistance potential with Cry3Bb1 and Cry34/35Ab1 7/31/2014 49492501 In Review 10/20/2014 German Cockroach Pheromone BPPD 9/23/2004 5-batch analysis 8/1/2005 46469401 46539801 Satisfied 2/14/2005 5/4/2005 Harpin proteins BPPD 4/19/2000 1. Freshwater invertebrate pathogenicity 4/19/2001 45380401 Satisfied 4/17/2001 2. 5-batch analysis for survival of Harpin- producing E. coli in end-prodct and quatitation of human pathoqens 4/19/2001 45380402 Satisfied 4/17/2001 3. Sample media without antibiotics to detect bacterial contamination 4/19/2001 45380402 Satisfied 4/17/2001 4. PCR-based amplification to detect/estimate residual plasmid in end-product 4/19/2001 45380403 Satisfied 4/17/2001 Metarhizium anisoptiae F52 BPPD 6/6/2003 1. Manufacturinq process - upqrade 1/30/2011 48058801 Satisfied 4/12/2010 2. Formation of unintentional ingredients - upqrade 1/30/2011 47880601 48177001 Satisfied 10/9/2009 8/6/2010 3. Freshwater Fish Testing - repeat 1/30/2011 Waiver requested Waived 12/9/2004 1/14/2008 4. Product identity - upqrade 1/30/2011 47123901 Satisfied 5/4/2007 6/1/2015 7 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received MIR162 BPPD 11/26/2008 1. Analytical method validation 11/1/2009 N/A Satisfied 6/15/2009 (Vip3Aa20) 2. 7-14 day Daphnia study or aquatic invertebrate dietary study 11/1/2009 47779102 Satisfied 5/1/2009 MIR 604 (mCry3A) BPPD 10/3/2006 1. 3-year field degradation study 1/31/2011 Waiver requested Waived N/A 2. 3-year full-scale field or semi-field studies - non-tarqet invertebrates 1/31/2011 48285801 In Review 11/4/2010 MOCrylF (Event DAS-06275-8) BPPD 5/27/2005 1. Independent laboratory validation of analytical method Not specified 46656101 Satisfied 10/3/2005 Registration of products containing this active ingredient will expire 9/30/2015. 2. Confirm moCrylF protein levels in soil under range of conditions typical for Bt corn cultivation. 3/15/2008 47120702 Satisfied 5/7/2007 3. Confirmatory non-tarqet insect field data 3/15/2008 46784601 Satisfied 3/15/2006 MON 89034 (Cry1A.105 and BPPD 6/10/2008 1. 7-14 day daphnia study or aquatic invertebrate dietary study 4/1/2009 47838801 Satisfied 8/27/2009 Cry2Ab2) 2. Info on cross-resistance of Cry1A.105, CrylF and CrylAc for target pests, and impact on the durability of MON 89034 4/1/2009 47838801 Satisfied 8/27/2009 3. Sweet Corn: baseline susceptibility studies of major pests 4/1/2009 47791201 47791202 47791203 Satisfied 7/14/2008 6/30/2009 6/30/2009 4. Sweet corn: baseline Fall Army Worm susceptibility studies to the 2 proteins 4/1/2009 48588801 48588802 48588803 Satisfied 8/30/2011 5. Analytical method validation, including reaqents/methodoloqy 4/1/2010 47731601 Satisfied 4/22/2009 Muscador albus BPPD 9/22/2005 1. 5-batch analysis Not specified 47526001 Cancelled 9/2/2008 Registrations of products with this active 2. Storaqe stability 9/1/2008 47526002 Cancelled 9/2/2008 ingredient were cancelled on 10/4/2010. 2. Acute inhalation toxicity 1/31/2007 47043801 Cancelled 1/31/2007 Nuclear Polyhedrosis Virus of Anagraphs falcifera BPPD 8/92002 Analysis of samples 1/8/2003 46228201 Satisfied 3/22/2004 Oil of Black Pepper and Piperine BPPD 3/18/2004 Storage stability 12/1/2005 46717901 Satisfied 12/27/2005 Paecilomyces lilacinus strain 251 BPPD 3/30/2005 Acute intraperitoneal toxicity pathogenicity study 9/30/2006 46950401 47197501 Satisfied 8/6/2007 1. Analysis of Samples 5/1/2011 48453101 Satisfied 4/14/2011 Product identity requirement will be 2. Manufacturinq process 10/1/2009 47885301 Satisfied 10/16/2009 satisfied when the microorganism Pasteuria usgae BPPD 6/2/2009 3. Storaqe Stability 6/1/2010 48196201 Satisfied 8/17/2010 classification is determined by the 4. Product Identity When organism is classified N/A In review N/A International Committee for Systematic Bacteriology. Pseudomonas chloroaphis BPPD 9/28/2001 1. Data demonstrating production of siderophores 6/28/2004 46615902 46766902 Cancelled 8/4/2005 2/23/2006 This registration containing this active ingredient was cancelled on 7/22/2013. strain 63-28 2. Growth and survival of microbe at 10-25°C 6/28/2004 46615901 46615901 Cancelled 8/4/2005 2/23/2006 Pseudozyma flocculosa strain PF-A22 BPPD 9/20/2002 1. Confirmatory pulmonary toxicity/pathogenicity study 10/3/2003 7/1/2005 4/1/2006 9/20/2006 6/1/2007 10/31/2007 10/31/2008 N/A Cancelled N/A Registrations of products with this active ingredient were cancelled on 7/15/2011. 2. Storage stability 10/3/2003 7/1/2005 4/1/2006 9/20/2006 6/1/2007 10/31/2007 10/31/2008 N/A Cancelled N/A 3. Certificates of Analysis Not specified N/A Cancelled N/A 6/1/2015 8 of 35 ------- Chemical Division Ren Notice Date Conditional Data Requirement(s) MRID for Studv Review Status Date Data Comments Trypsin modulating oostatic factor (TMOR BPPD 5/24/2004 Storage Stability 5/24/2006 N/A Cancelled N/A Registrations of products with this active ingredient were cancelled on 7/21/2005. Xanthomonas campestris pv vesicatoria and Pseuodomonas syringae pv tomato (2 active innrpHipntc) BPPD 12/9/2005 PCR-based screen maintain/report QA/QC 6/9/2006 46887301 Satisfied 6/12/2006 Registrationsof products with this active ingredients requires ongoing QA/QC data to be submitted to EPA whenever requested. All other conditions of registration are satisfied. Quillaja saoonaria extract BPPD 7/14/2007 Product performance (efficacy) 7/15/2010 47645201 to 47645212 48151401 Satisfied 1/15/2009 7/15/2012 Trichoderma harzianum strain BPPD 5/25/2000 1. Efficacy of PCR-RAPD protocol for strain identity 8/25/2000 N/A Cancelled Not submitted Registrations of products with this active ingredient were cancelled on 7/21/2005. T-39 2. 5-batch analysis 5/25/2001 N/A Cancelled Not submitted 3. Freshwater invertebrate study verification Not specified 44890101 Cancelled 8/23/2000 4. Plant-pathoqenicity Not specified N/A Cancelled Not submitted 5. Non-tarqet insect (Ladybird beetle) Not specified N/A cancelled Not submitted 6. Upgrade honeybee study 5/25/2001 45244001 Cancelled 9/22/2000 (Z,E)-9,12 Tetradecadien-1- vl acetate BPPD 3/13/2006 Storage stability 9/13/2007 48830401 Satisfied 5/17/2012 The conditions of registration are satisfied. Z,Z-3,13- BPPD 4/20/2006 Storage stability 10/20/2007 2/28/2014 49313401 Satisfied 2/6/2014 New registration notice mailed to Octadecadien-1 -ol Corrosion characteristics 10/20/2007 2/28/2014 49313401 Satisfied 2/6/2014 registrant 9/25/2014 1 .Freshwater invertebrate (Daphnia) study 9/26/2004 46372101 Satisfied 9/29/2004 Acequinocyl RD 9/26/2003 2. Acute sediment toxicity test for freshwater invertebrates for the major metabolite, deacetylated acequinocyl; pending results on freshwater invertebrates, the test for sediment dwelling estaurine/marine invertebrates may be required. If required, it is to be submitted within 1 year of the date of the Agency's notification to company 9/26/2004 46372101 Satisfied 9/24/2004 3. Acute toxicity study for the deacetylated acequinocyl using fish (rainbow trout; or bluegill sunfish) 9/26/2004 46370502 Satisfied 9/24/2004 4. Acute toxicity study for the deacetylated acequinocyl using an aquatic invertebrate using daphnids or mysids as the test species 9/26/2004 46372101 Satisfied 9/24/2004 Storage stability and corrosion characteristics 9/26/2005 46372101 Satisfied 8/5/2005 Acetaminophen RD 3/21/2003 Conditionally registered but no data requirements N/A N/A N/A N/A Storaqe Stability Data for Rotational Crops 3/5/2004 46729102 Satisfied 1/12/2006 Acetamiprid RD 3/5/2002 Radio validation data for IM-2_1 amide in ruminant muscle 8/5/2002 Waiver Rquested Waived 12/17/2002 Waiver requested on 12/17/02. Data indicate that residues of IM-2-1 amide in ruminant muscle can be estimated by applying a 10-fold factor to residues of IM- 2-1 in muscle. Submission of these data would result in the use of empirical data in risk assessments and removal of the 10- fold factor used to estimate residues of IM 2-1. Avian Reproduction 3/5/2003 46369201 46555601 Satisfied 6/16/2003 Acute Aquatic Invertebrate 3/5/2003 45932501 45916201 49034202 Satisfied 5/14/2003;01/09/2 013 6/1/2015 9 of 35 ------- Chemical Division Reg Notice Date Conditional Data Reauirementfs) MRID for Studv Review Status Date Data Comments m, Freshwater Fish Early Life-Stage 8/5/2002 n/a Satisfied n/a Decision made that no further data are required. Toxicity of Foliar Residue to the Honey Bee 3/5/2003 45932505 45932504 Satisfied 5/14/2003 Tier II Phototoxicity, Veqetative Viqor - Lettuce 3/5/2003 46229602 46229601 Satisfied 2/10/2004 1. Developmental neurotoxicity study in rats 8/11/2002 46046401 Satisfied 7/3/2003 2. Subchronic neurotoxicity study in rats 8/11/2002 45713601 Satisfied 7/11/2002 Acibenzolar-s- methyl RD 8/11/2000 3. Mutagenicity study (Ames assay) with technical-grade acibenzolar-s-methyl (prepared by a new "thiazole" production process) 8/11/2002 48490001 48490002 48490003 Satisfied 5/24/2011 4. Soil photolysis study 8/11/2001 45434103 45434104 In Review 6/20/2001 Upqrade 5. Aerobic soil metabolism study 8/11/2001 45434103 45434104 In Review 6/20/2001 Upqrade 6. Aerobic aquatic metabolism study 8/11/2001 45434103 45434104 In Review 6/20/2001 Upqrade 7. One of two Batch equilibrium study 8/11/2001 45434103 45434104 In Review 6/20/2001 Upqrade Alpha-Chlorhydrin RD 12/7/2006 Registered conditionally but no data required N/A N/A N/A N/A 1. Storaqe Stability 8/30/2011 48372401 Satisfied 2/1/2011 2. Corrosion Characteristics 8/30/2011 48372401 Satisfied 2/1/2011 3. 5-batch analysis from commercial-scale production of product, 8/30/2011 48720201;48720202 Satisfied 1/18/2012 Aminocyclopyrac hlor RD 8/30/2010 4. Repeated dose in sensitive species to address chronic exposure 8/30/2012 48830801 In Review 5/17/2012 90 Day Oral Gavage Study in Rats with Deqradate IN-V097. 5. Avian Reproduction 8/30/2012 10/1/2016 48333632;48333633 In Review 1/25/2011 new waterfowl study needed 6. Freshwater Invertebrate Life Cycle Toxicity Study 8/30/2012 48576201 In Review 8/11/2011 1. Nature of the residue-Plants no date specified 49133501 Satisfied 5/23/2013 2. Nature of the residue-Livestock no date specified 48237521 In Review 10/5/2010 3. Residue Analytical Methods no date specified 48237521 In Review 10/5/2010 4. Storaqe stability no date specified 48612001 Satisfied 9/29/2011 5. Meat, poultry and eggs - poultry feeding study no date specified 49135508 In Review 5/23/2013 Waiver submitted 6. Crop field trials no date specified 49133502 49133503 In Review 5/23/2013 7. Field accumulation in rotational crops no date specified 49135504-07 In Review 5/23/2013 8. Acute Avian Dietary (Quail) no date specified 48237511 Satisfied 10/5/2010 9. Avian reproduction no date specified 48237512,48237513, 48237514,48237515 Not Satisfied 10/5/2010 48237512, 48237514,48237515 satisfied; 48237513 needs to be repeated. 10. Aquatic Invertebrate Life Cycle - Saltwater no date specified 48407503 Satisfied 3/8/2011 11. Aquatic invertebrate life cycle no date specified 48071501 Satisfied 4/22/2010 Amicarbazone RD 10/4/2005 12. Tier II vegetative vigor no date specified 48237518,48237519, 48237520 Satsified 10/5/2010 13. Tier II seedling emergence and vegetative viqor no date specified 48237516,48237517 Satisfied 10/5/2010 14. Aerobic soil metabolism no date specified 48237507 Satisfied 10/5/2010 15. Aerobic water/sediment metabolism no date specified 48237508 Not Satisfied 10/5/2010 Study needs to be repeated 16. Hydrolysis for degradates no date specified 48073601 48237506 Satisfied 4/26/2010, 10/5/2010 17. Aerobic soil metabolism fro Des-amino, N- methyl des-amino. no date specified 48407501 48407502 Satisified 3/8/2011 18. Analytical reference standards to the EPA National Pesticide Standards Repository: DA amicarbazone, iPr-2-OH DA Amicarbazone, aminocarbazone-d9, iPr-2-OH DA amicarbazone- d6. no date specified Not Satisfied 19. Fish early life staqe no date specified 48237510 Satisfied 10/5/2010 1. Completed enforcement method of analysis to show that the analytical method differentiates between aminoyralid, picloram and clopyralid no date specified 46729001 Satisfied 1/12/2006 nn Status 6/1/2015 10 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 2. The completed enforcement method to EPA Fort Meade Laboratory for validation no date specified 46729000 Satisfied 1/12/2006 Aminopyralid RD 8/10/2005 3. Storage stability data for grass forage and hay reflecting up to approximately 15 months of frozen storaqe no date specified 46661301 Satisfied 10/11/2005 4. Repeated Aerobic Soil Metabolism Study no date specified 47911201 Satisfied 11/13/2009 5. Repeated Avian Reproduction study in bobwhite quail no date specified 47109901 Satisfied 4/20/2007 6. Repeated Tier II Aquatic Plant Growth: Blue- qreen alqae, Anabaena flos aquae no date specified 47109902 Satisfied 4/20/2007 Indaziflam RD 7/26/2010 1. Estuarine/Marine Invertebrate Life Cycle 7/26/2012 49073301 In Review 70/1/2013 2. Avian reproduction study on Mallard duck 7/26/2012 48892801 In Review 7/30/2012 1. Storage stability data for the benzene-labeled rate rice metabolism study 9/24/2003 46076600 Satisfied 9/22/2003 2. Poultry feeding study 9/24/2003 48060601 waiver requested Waived 4/13/2010 waiver; DP 377208; acceptable Bispyribac- RD 9/24/2001 3.28-day inhalation 9/24/2003 48578001 waiver requested Waived 8/22/2011 waiver; DP 394228; under review4/2014 Sodium 4. In vitro mammalian cell qene mutation assay 9/24/2003 46076601 Satisfied 9/22/2003 5. Residue data generated for the vegetative viqor of terrestrial plants 9/24/2003 waiver requested Waived 9/30/2002 waiver; DP 287947; acceptable 6. Residue data generated for the seedling emerqence of terrestrial plants 9/24/2003 waiver requested Waived 9/30/2002 waiver; DP 287947; acceptable 7. Toxicity study to qreen alqae 9/24/2003 46076602 Satisfied 9/22/2003 1. Radiovalidation study to support the adequacy of the proposed tolerance 12/31/2002 46220001 Satisfied 3/11/2004 2. Radiovalidation data demonstrating the efficiency of the microwave hydrolysis step in Method 476/0 12/31/2003 46220002 Satisfied 3/11/2004 3. All proposed data collection and tolerance methods, revised to state that solutions of analytical standards should not be stored longer than 2 months before replacement 8/30/2004 46351401,46351402, 46351403 In Review 8/31/2004 4. Final Report of the storage stability study in plant matrices with description of the fortification solutions (solvent) used in the study and a full description of the analytical method (445/0) 8/30/2004 46351404,46351405 In Review 8/31/2004 5. Data demonstrating the frozen storage stability of BAS 510 F residues in processed grape juice (2 months) and tomato paste (5 months) 12/31/2003 46160103;45405126; 45405109;47584402. Satisfied 12/23/2003; 4/3/2001;4/3/2001 ; 2/3/2009. 6. Additional field trials, conducted per their 8/31/2004 46655106 Satisfied 10/11/2005 respective proposed use pattern by 8/31/2004 3 for mustard greens (one each from Regions 2,3, and 10) 8/31/2004 46512001 Satisfied 3/31/2005 2 for cucumber (one each from Regions 2 and 10) 8/31/2004 46512002 Satisfied 3/31/2005 1 for sunflower seed (from Reqion 5) 8/31/2004 46512003 Satisfied 3/31/2005 Boscalid RD 7/21/2003 7. Limited field accumulation study which provides data on beet tops (sugar or garden) and turnip tops, from beets and turnips planted as rotational crops into treated soil 14 days following the last of 3 applications of BAS 510 F totalinq -1.8 lbs ai/A 8/31/2004 46210606 Satisfied 3/2/2004 6/1/2015 11 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 8. Limited field accumulation study which provides residue data on spinach and celery, planted as rotational crops into treated soil 14 days following the last of 3 applications of BAS 510 F totaling -1.8 lbs ai/A (alternatively, the petitioner may submit a full set of crop field trials data for spinach (6) and celery (6), via a use pattern similar/identical to that for lettuce, and 8/31/2004 46145101,46145102 Satisfied 12/1/2003 request a direct use tolerance on all of crop qroup 4 9.Demonstration that pH, water hardness, and the use of dechlorinated tap water do not affect the toxicity of Boscalid and if it can be demonstrated that mean measured 8/31/2004 waiver requested Waived 11/18/2004 concentrations accurately reflect the amount of chemical in solution, so aquatic toxicity tests using fish and invertebrates may be upgraded to core studies. 10. Provide data on growth (length and weight) of Daphnia magna in the freshwater invertebrate 8/31/2004 46351406,45405005 Satisfied 8/31/2004 life cyle study. 11. Provide data for freshwater mollusc such as Corbicula spp., given the persisitence of Boscalid and its tendency to partition onto 8/31/2004 waiver requested Waived sediments, 12. 21/28 day inhalation study 8/31/2004 waiver requested In Review n/a 13. Dermal sensitization 8/31/2004 46270102 Satisfied 5/13/2004 1. Developmental neurotoxicity study in rats 12/31/2003 45819101 Satisfied 12/10/2002 2. Storage stability data validating the following intervals for buprofezin, BF 9, and BF 12: cucumber (26 months); summer squash (12 months); lettuce (31 months); wheat forage, hay and straw (29 months); wheat grain (21 months); sugar beet top and root (24 months); mustard greens (28 months); turnip tops and roots (29 months); carrot (26 months). 12/31/2003 44576916;46804701 Satisfied 1/30/2001; 4/6/2006 RD 8/31/2000 3. Frozen storage intervals for cantaloupe (10 months); summer squash (12 months); cucumber (26 months) are to be validated. 12/31/2003 48488201;48488202; 48488203 Satisfied 5/20/2011; 6/13/2011 Buprofezin 4. Cantaloupe field trials in Regions 2 and 10. 12/31/2003 48488202 Satisfied 6/13/2011 5. Frozen sample interval for lettuce samples (28 months) to be validated. 12/31/2003 46804701 Satisfied 4/6/2006 6. Leaf lettuce field trials in Regions 1 and 10. 12/31/2003 47112003 Satisfied 4/20/2007 7. Data needed to upgrade the terrestrial field trial storage stability from upgradable to 12/31/2003 44576915 Satisfied 6/5/1998 acceptable. 8. Freshwater Fish Full Life Cycle Life 12/31/2003 48083904 Pending 4/1/2015 repeat study due 4/2015 1. Ruminant feeding study 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 2. Repeat of the 21-day chronic toxicity test with freshwater invertebrates 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 3. Repeat of the acute toxicity study on plants with a plant species that can provide a better representation of the toxicity of parent butafenacil to vascular plants 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 Butafenacil RD 9/29/2003 4. Chronic toxicity test with an estuarine/marine invertebrate species. 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 6/1/2015 12 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 5. Repeat of the tier II seedling emergence 123- 1(a) 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 6. Repeat of the veqetative viqor 123-1 Cb) 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 7. Acute fish study with parent butafenacil in the presence of natural sunlight or an equivalent source 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 8. Frozen storaqe stability data 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 9. Ruminant validation method 9/29/2006 N/A Cancelled N/A all products cancelled on 7/16/07 1. Acute neurotoxicity study in rats 6/1/2003 46012992,46012947 Satisfied 2. Subchronic neurotoxicity study in rats 6/1/2003 46012921,46012946 Satisfied 6/3/2003 3. Developmental neurotoxicity study in rats 6/1/2003 46012925 Satisfied 6/3/2003 4. In vitro cytoqenetic assay 6/1/2003 46012919 Satisfied 6/3/2003 5. Nature of the residue in plants 6/1/2003 46012908,46012909 Satisfied 6/3/2003 6. Residue analytical methods 6/1/2003 46012912,46012914 Satisfied 6/3/2003 7. Storaqe stability data 6/1/2003 46012916,46012917 Satisfied 6/3/2003 Ciodinafop- propargyl 8. Maqnitude of the residue in plants 6/1/2003 46012918 Satisfied 6/3/2003 RD 6/6/2000 9. Hydrolysis 6/1/2003 46012926 Satisfied 6/3/2003 10. Photolysis in water 6/1/2003 46012927,46012928 Satisfied 6/3/2003 11. Anaerobic soil metabolism on deqradate 6/1/2003 Not Submitted Waived 6/3/2003 Reqirement withdrawn 12. Adsorption/desorption 6/1/2003 46012934,46012935, 46012936,46012937 Satisfied 6/3/2003 13. Field dissipation 6/1/2003 46012939 Satisfied 6/3/2003 14. Aerobic soil metabolism 6/1/2003 46012930,46012931 Satisfied 6/3/2003 15. Avian reproduction 6/1/2003 46012945 Satisfied 6/3/2003 16. Seedlinq emerqence/veqetative viqor 6/1/2003 46012902,46012901 Satisfied 6/3/2003 1. Developmental immunotoxicity study 5/30/2006 46536502,46536501 Satisfied 4/29/2005, 2008 2. Additional analysis of test materials used in mutaqenicity studies 5/30/2006 46339001,46339002, 46339003, 46339004 Satisified 8/10/2004 Clothianidin RD 5/30/2003 3. Rotational crop residue field trials with mature soybeans 5/30/2006 46826901 Satisfied 5/15/2006 4. Aerobic aquatic metabolism 5/30/2006 46826903 Satisfied 5/15/2006 5. Seed leachinq study 5/30/2006 46826904 Satisfied 5/15/2006 6. Whole sediment acute toxicity to freshwater invertebrates 5/30/2006 46826902 Satisfied 5/15/2006 7. Field test for pollinators 5/30/2006 46907801,46907802 Satisfied 8/9/2006 1. All the submitted fate and transport studies were classified either supplemental or unacceptable. Therefore, the registrant is required to respond to notes present in all of the EFED DERs. The identified data gaps must be resolved by submitting additional details about the methods or results. If the studies cannot be upgraded, new studies may be required 3/31/2005 446537701 46537702 46537703 46537704 46537705 46537706 46537707 46537709 46537710 46537711 46537712 46537713 46537714 46537715 46537716 46537717 46537719 46537720 46537722 46537723 46537724 46784201 46784202 Satisfied 5/2/05, 3/15/06 (last 2) 2. Hydrolysis/aerobic soil on the degradate CCTS to look into the fate of this degradate and to confirm that the degradates HTID, CDTS and p-Toluamide were only photolytic degradates resultinq from lonq exposure to liqht 11/30/2006 46537725 (waiver requested) Waived 5/2/2005 3. Replacement avian reproduction study using bobwhite quail to establish valid NOAECs for parent cyazofamid and the CCIM deqradate 11/30/2006 45638515,47716308 Satisfied 3/28/02, 3/31/09 4. Freshwater Invertebrate Life Cycle Test using the parent 11/30/2006 46702708,47716307 Satisfied 12/5/05, 3/31/09 6/1/2015 13 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Cyazofamid RD 11/9/2004 5. Photodeqradation on Soil 11/30/2005 46702704 Satisfied 12/5/2005 6. Aerobic Soil Metabolism (Two relevant U.S. soils) 11/30/2005 47716301 (waiver request) Waived 3/31/2009 7. Aerobic Aquatic Metabolism (One water sediment system) 11/30/2005 47716303 Satisfied 3/31/2009 8. Anaerobic Aquatic Metabolism (One water sediment system) 11/30/2005 47716302 Satisfied 3/31/2009 9. Bio-accumulation in Fish Study 11/30/2005 47716305 Satisfied 3/31/2009 10. Nature of Residue: Information pertaining to dates of sample collection, extraction, final analysis. Representative chromatograms of the radiolabeled residues taken before and after storaqe under frozen conditions 3/31/2005 46537726, 46537727, 46537728 Satisfied 5/2/2005 11. Storage Stability data for 18 months on the representative commodities of the cucurbit required to support the storage intervals and conditions of the crop field trials 11/30/2006 46989701 In Review 11/21/2006 12. Confined Accumulation in Rotational Crops: Data to confirm the actual sample storage interval storage stability data indicate that the parent and its metabolites CCIM and CCBA are stable in fortified samples of carrot roots, lettuce, and wheat forage stored frozen for at least 4 months 11/30/2006 46537726, 46537727, 46537728 Not Satisfied 5/2/2005 1. Acute neurotoxicity study 6/27/2013 49128101 In Review 5/16/2013 Cyflufenamid RD 6/27/2012 2.Sample storage stability associated with the apple metabolism study must be submitted for a period than covers 17 months. 6/27/2014 In Review Waiver submitted 12/2012 1. 28-day inhalation toxicity study 6/1/2006 46471101 Satisfied 2/15/2005 Cyhalofop-butyl RD 5/23/2002 2. Carcinogenicity study in rats 6/1/2006 46471101,46471102, 46471103 Satisfied 2/15/2005 3. Carcinogenicity study in mice 6/1/2006 46471101,46471102, 46471103 Satisfied 2/15/2005 1. New ames mutagenicity test conducted at adequate dose levels 2/28/2001 45225501 In Review 10/2/2000 Will be reviewed in registration review 2. Additional information concerning the metabolism study for poultry and eggs and the rotational crop study. The storage time between sampling and analysis for poultry, eggs, and rotational crops must be reported. If the storage time was longer than 6 months, adequate data concerning the stability of residues during the storage period between collection and final analysis. 2/28/2001 45225500 In Review 10/2/2000 Will be reviewed in registration review Diclosulam RD 3/8/2000 3. Analysis of plant metabolism or field trial samples of peanut and soybean for 2,6-DCA using a validated method at the parts per billion level. The storage time b/t sampling and analysis for 2,6-DCA must be reported. If the storage time was longer than 6 mo., adequate data concerning the stability of residues during the storage period b/t collection and final analysis must be provided 2/28/2001 45225500 In Review 10/2/2000 Will be reviewed in registration review 4. Additional positive control data and untransformed motor activity data for the acute neurotoxicity study and the 1-year neurotoxicity study 2/28/2001 45225502,45225503, 45225504, 45225505, 45225506 In Review 10/2/2000 Will be reviewed in registration review 6/1/2015 14 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Difenacoum RD 9/28/2007 Reqistered conditionally but no data required no data req. N/A N/A N/A 1. Field Volatility from Soil study 6/30/2012 4/1/2014 9/1/14 7/13/2012 Protocol received 7/13/2012; approved with comments 3/8/2013. Due date extended to 4/01/2014. 2. Estimation of inhalation Exposure, outdoor Sites 12/31/2013 4/1/2014 9/1/14 7/13/2012 Protocol received 7/13/2012 an approved with comments 3/8/2013. Due date extended to 4/01/2014. 3. Environmental Chemistry Methods and Independent Laboratory Validations for Soil, Water, and Air 6/30/2011 48128201,48535303, 48575201 Air- Satisfied; Soil and Water In review 6/21/10 and 8/15/11 4. Aerobic Aquatic Metabolism study 9/30/2011 48662501 Satisfied 3/5/2012 Dimethyl disulfide RD 7/9/2010 5. Anaerobic Aquatic Metabolism study 9/30/2011 48662502 Satisfied 3/5/2012 6. Vegetative Vigor study 9/30/2011 Response submitted but no Mrid assiqned In review 5/29/2014 Partially satisfied. Registrant submitted additional raw data. 7. Aquatic Freshwater Invertebrate Life-Cycle Toxicity study 9/30/2011 48662504 In Review 3/5/2012 8. Aquatic Saltwater invertebrate Life-Cycle Toxicity study 9/30/2011 48662506 In Review 3/5/2012 9. Freshwater Fish Early Life-Stage Toxicity study 9/30/2011 48662503 In Review 3/5/2012 10. Saltwater Fish Early Life-Stage Toxicity study 9/30/2011 48662505 In Review 3/5/2012 1. Stability to metals and metal ions no date specified 46403801 Satisfied 11/12/2004 2. Confirm sample extraction and analysis dates for MRID 45639822. 12/17/2004 No MRID assigned Satisfied 2/3/2005 Information submitted in conjunction with a new use application. 120 Day plant back interbal retained. 3. Confirmatory dermal absorption study in the rat 9/17/2005 47013401 Satisfied 12/22/2006 4. Developmental neurotoxicity study in the rat 9/17/2006 47677502 48291601 Satisfied 2/17/2009 5. Developmental immunotoxicity study in the rat with comparative measures between pups and the parents. 9/17/2006 47677501 Satisfied 2/17/2009 6. Photodegradation in soil 9/17/2005 45640109 Satisfied 8/24/2010 Referred to study reed 3/19/2002. Satisfied Dinotefuran RD 9/17/2004 7. New aerobic soil metabolism or upgrade 2nd study (MRID 45640112) by addressing the characterization of the major degradates at various samplinq intervals. 9/17/2005 46711201,46711202 Satisfied 12/16/2005 8. Anaerobic Aquatic/soil metabolism study needs to be upgraded if direct application to water is proposed. not specified 48680002 Satisfied 12/6/2011 submitted with rice application. Satisfied 9. Aerobic aquatic metabolism study needed for any future aquatic uses. not specified 48680002 Satisfied 12/6/2011 submitted with rice application. Satisfied 10. Repeated fish early life stage toxicity test 9/17/2005 45639719 Satisfied 8/24/2010 Referred to study reed 3/19/2002. Satisfied. 11. Avian acute oral test using bobwhite quail or mallard duck 9/17/2005 47353601 Satisfied 2/25/2008 Satisfied 12. Aquatic invertebrate life cycle test is needed for any future aquatic uses. not specified 45639718 Satisfied 8/24/2010 Referred to study reed 3/19/2002. Satisfied. Eco2Fume RD 12/20/1999 Conditionally registered under 3(c )(7)(c) but no data requirements no data req. N/A N/A 6/1/2015 15 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 1. Product chem. Data that is partially satisfied and needed: product identity and discussion of ingredients, beginning materials and manufacturing process, formation of impurities, prelim analysis, analytical methods to verify cert limits, and stability. NOT satisfied: oxidizing or reducing action, explodability, storage stability, corrosion characteristics. 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 2. hydrolysis study needs the % of phenyl-ring transformation products that are present after 30 days 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 3. Photodegradation in water: electronic absorption spectra of ethametsulfuron methyl at ph5 and 9. 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 Ethametsulfuron RD 4/23/2001 4. Aerobic soil metabolism: triazine radiolabeled study to address comments in study review. 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 Methyl 5. Terrestrial field dissipation study: Analytical method for identifying and quantifying residues of "cold" ethametsulfuron methyl must be evaluated 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 6. Freshwater fish full life-cycle 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 7. Tier II seed germination/seed emergence 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 8. Tier II vegetative vigor 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 9. Tier II Lemma gibba, Skeletonma costatum, blue green algae 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 10. Batch equilibrium adsorption/desorption study were conducted with acidic soils taken from eastern states. At least 2 alkaline soils should be included. Soil TLC studies only provide ancillary data. 4/23/2005 N/A Cancelled N/A all products cancelled on 2/20/13 11. Additional information required for acute inhalation and dermal sensitization studies. Refer to review. 4/23/2005 N/A N/A N/A all products cancelled on 2/20/13 1. Acute and subchronic neurotoxicity 3/1/2003 45932301,45925701 Satisfied 4/22/2003 2. Development neurotoxicity 9/1/2003 46062301 Satisfied 8/28/2003 Etofenprox RD 9/14/2001 3. Residential "Indoor Surface Residue Dissipation Study following Total Release Product Use" 9/1/2003 46075002 Satisfied 9/3/2006 4. Residential "Indoor Air Concentration Measurements following Total Release Product Use" 9/1/2003 46075003 Satisfied 9/3/2006 5. Product Performance Data for cockroaches, fleas, ticks, and mosquitoes 9/1/2002 46066506 Satisfied 9/5/2003 1. Core freshwater fish acute toxicity studies not specified 46059001,46059002 Satisfied 8/25/2003 Etoxazole RD 8/22/2002 2. 90-day subchronic inhalation study on rats not specified 48134301 waiver requested Waived 6/28/2010 1. Leaching/Adsorption/Desorption study (one additional soil type which should be finer-grained than those previously tested-which were sand, sandy/loam, and sandy/clay/loam) 8/31/2004 46350401 Satisfied 8/30/2004 Study Supplemental, requirement satisfied Famoxadone RD 7/17/2003 2. Acute freshwater fish (Rainbow trout) quideline study usinq the end-use product 8/31/2004 46144801 Satisfied 12/4/2003 3. Whole sediment acute toxicity invertebrates, freshwater chironomids, the 28-day test 8/31/2004 10/01/2014 12/31/14 6/30/15 44946308 Not Satisfied 12/31/2014 Registrant submitted rebuttal. Rebuttal denied. Study due date 12/31/14 4. Honey-bee acute contact with the end-use product bv 8/31/2004 46350402 Satisfied 8/30/2004 6/1/2015 16 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 5. Honey-bee toxicity of residues on foliage with the end-use product 8/31/2004 46350403 Satisfied 8/30/2004 1. Honey bee acute contact LD50 Dec-03 45802901 Satisfied 11/19/2002 2. Mallard duck reproduction Dec-04 46418601 Satisfied 12/6/2004 3. Freshwater fish early life-stage or fish full life cycle Dec-04 47332201 waiver request; 48389201 study Satisfied 12/6/2004; 02/16/2011 Waiver denied; study satisfied requirement. 4. Aerobic soil metabolism Dec-04 45385819 Satisfied 11/21/2002 5. Residue analytical methods-plants any modification or revisions recommended by the Aqency Jun-03 no modifications requested Satisfied 11/21/2002 Fenamidone RD 9/30/2002 6. Confined accumulation in rotational crops- fenamidone labeled in the N-phenyl ring (aniline and substituted aniline standards should be included) Dec-03 waiver requested Waived 11/21/2002 7. Confined accumulation in rotational crop study Dec-03 46440805, 47514101, 47514102, 47514103 Satisfied 1/2/2005 8/12/2008 8/12/2008 8/12/2008 8. Storage stability data for the confined accumulation in rotational crop study Dec-03 47817002 Satisfied 7/30/2009 10. Developmental neurotoxicity study Dec-03 46501102,46590001 Satisfied 3/18/04, 7/12/05 11. 28-day inhalation toxicity study Dec-03 47465801 wiver requested Waived 7/2/2008 12. Storage Stability Mar-04 47120801 5/2/2007 13. Corrosion Characteristics Mar-04 46152101 Satisfied 12/15/2003 Fenpyroximate RD 9/29/2000 1. Confirmatory data must be submitted for the existing rat developmental study including additional historical control data. 9/27/2003 45323301 Satisfied 2/6/2001 2. 28 day inhalation study 9/27/2003 45323302 Satisfied 2/6/2001 3. Aerobic soil metabolism and 9/27/2003 45649708 Satisfied 4/1/2002 adsorption/desorption (batch equilibrium) study. 1. One-year storage stability and corrosion characteristics 11/14/2008 46220905 Satisfied 3/2/2004 Agency letter, dated 11/20/08, states that the study submitted with the application satisfies the requirement. 2. Acute neurotoxicity study including historical positive control data, analytical data verifying homogeneity, and stability of formulated test materials for this study. 6/30/2009 47785301 Satisfied 6/23/2009 DP366699, acceptable DP404895, under review DP408778, under review 3. Aerobic aquatic metabolism 6/30/2009 47785302 Satisfied 6/23/2009 DP366710; supplemental, satisfies requirement 4. Aerobic soil metabolism 6/30/2009 47785303 Satisfied 6/23/2009 DP366710, acceptable Flazasulfuron RD 5/14/2007 5. Anaerobic aquatic metabolism 6/30/2009 47785304 Satisfied 6/23/2009 DP366710; supplemental, satisfies requirement 6. Soil Mobility: Adsorption/desorption (parent) 6/30/2009 47030002 Satisfied 1/2/2013 7. Freshwater fish early life-staqe 6/30/2009 47785305 Satisfied 6/23/2009 DP366710, acceptable 8. Aquatic invertebrate life-cycle (freshwater) 6/30/2009 47785306 Satisfied 6/23/2009 DP366710; supplemental, satisfies requirement 10. Aquatic vascular plant (duckweed) study 6/30/2009 47785307 Satisfied 6/23/2009 DP366710; supplemental, satisfies requirement 11. Seedling emergence (Tier II) 6/30/2009 47785308 Satisfied 6/23/2009 DP366710, DP372895 acceptable 12. Studies need to be conducted on the hydrolysis degradates DTPU and DTPP at the pH(s) at which they are most stable to hydrolysis no date specified 47785309 Satisfied 6/23/2009 DP366710, acceptable 6/1/2015 17 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Flonicamid RD 9/25/2003 1. 90-day inhalation study to address concerns for repeated exposure via the inhalation route as a result of qreenhouse use 9/25/2005 waiver requested Waived waiver granted 5/9/2005 2. Storage stability/corrosion characteristics and UV/Visible absorption data 9/25/2005 46370701 Satisfied 10/26/2007 3. UV/Visible absorption data 9/25/2005 45911601 In Review 4/17/2003 1. Seedlinq emerqence study 9/28/2008 48651302 Satisfied 11/8/2011 Florasulam RD 9/28/2007 2. Independent laboratory validation study for the Florasulam method in soil and the 5-Hydroxy Florasulam Degradate in Soil by Capillary Gas chromatoqraphy with mass Selective Detector 9/28/2008 48651303 In Review 11/21/2008 3. 5-batch analysis on the samples produced on commercial scale and based on the analytical results, a revised CSF 9/28/2008 47595601 Satisfied 11/13/2008 4. One-year storage stability and corrosion characteristics studies 9/28/2008 48902101 Satisfied 4/3/2009 1. 28-day inhalation toxicity study in rats Dec-03 48571410 Satisfied 9/8/2011 Waiver request submitted in 2002 was deemed acceptable due to label mitigation (inclusion of respirator). Full study was submitted in 2011 as part of reqistration review 2. Developmental neurotoxicity study in rats (Submit protocol for Agency approval and submit the study 2 years after approval 3/13/2003 (protocol due) 4654401,47018301, 47037001 Satisfied 4/28/2005 Fluazinam RD 3/5/2003 3. Subchronic neurotoxicity screening battery in rats, required based on results of the developmental neurotoxicity study (must by submitted 2 years after notification by the Aqency N/A N/A Waived N/A Data not requested based on results of developmental neurotoxicity studies. 4. Processed commodity study on potatoes at a hiqher treatment level, 5x Dec-03 waiver requested and qranted Satisfied 1/17/2002 5. Photodegration in soil Dec-03 45584205 waiver requested Waived 10/28/2008 6. Terrestrial Field Dissipation and concurrent storaqe stability study Dec-04 48631521,48631522, 48631523 Satisfied 10/28/2008 7. Tier I or Tier II Terrestrial Plant Growth, seedling emergence and vegetative vigor by 12/2003 Dec-03 46172801,46172802 Satisified 1/15/2004 Flubendiamide RD 8/1/2008 Reqistered conditionally but no data required no additional data N/A N/A N/A 1. Refined analytical methods for the quantification of flucarbazone-sodium and its degradates in both soil and water (analytes of concern: flucarbazone-sodium, its sulfonamide and sulfonic acid degradates, O-desmethyl flucarbazone, N, O-dimethyltriazolinone, and N- methyltriazolinone 10/1/2001 46926101,46926102, 46926103 In Review 9/5/2006 2. 28-day rat inhalation study 10/1/2001 46168501 Satisfied 1/12/2004 3. A revised plant enforcement method which measures all residues of toxicological concern: flucarbazone-sodium; its N-desmethyl metabolite; and flucarbazone sulfonamide and its conjugates. Also submit an independent laboratory validation and radiovalidation of the method 10/1/2001 46223700 Waived 3/18/2004 6/1/2015 18 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Flucarbazone RD 9/29/2000 4. Additional residue field trial data on the sulfonamide metabolite and its conjugates. If the company can provide adequate storage stability data from the previously conducted field trials, the samples from these field trials may be analyzed for sulfonamide and its conjuqates 10/1/2001 46223700 Waived 3/18/2004 5. Additional data on the sulfonamide metabolite and its conjugates in grain samples from the submitted processed food/feed study, should re- analyze grain samples from this study for flucarbazone sulfonamide and its conjugates. If quantifiable residues are found in the grain, then you must conduct a processinq study 10/1/2001 46223700 Waived 3/18/2004 6. Additional storage stability data from the submitted rotational crop studies for turnip tops and kale 10/1/2001 46103702 Satisfied 10/1/2003 7. Field rotational crop studies supporting the 11- month plant back interval for canola, barley and field peas 10/1/2001 46083802 In Review 10/1/2003 8. Seedling emergence and vegetative vigor data for sulfonamide degradate (test plant species should include lentil, canola, oat, onion, suqarbeet and buckwheat) 10/1/2001 46103701 Satisfied 10/27/2003 9. Three field dissipation studies conducted on bare qround 10/1/2001 46223703, 46223704 Satisfied 3/18/2004 1. Additional storage stability data for the metabolite S-3153 acid-4-OH in field corn and stover 9/30/2004 46028601 Satisfied 7/10/2003 Flufenpyr-ethyl RD 9/30/2003 2. Confirmatory method for residues of flufenpyr- ethyl in/or on corn, soybeans, sugarcane raw agricultural commoditities (RACs) by 9/30/2004. If the confirmatory method does not utilize a mass-selective detector (MSD), then an interference study will be required. 9/30/2004 46028602 Satisfied 7/10/2003 1. Confirmatory residue analytical method for plants 4/12/2003 45914603 Satisfied 4/22/2003 Flumioxazin RD 4/12/2001 2. Aqueous photolysis 4/12/2003 45914601 Satisfied 4/22/2003 3. Anaerobic soil/aqueous soil metabolism 4/12/2003 45914602 Satisfied 4/22/2003 4. Field dissipation 4/12/2003 46163701 Satisfied 4/22/2003 1. Additional storage stability data are needed for celery and spinach relfecting a storage interval of 38 months. One study should be conducted on any representative leafy vegetable. 1/31/2009 49054401,49054402, 49054403, 49054404 Satisfied 2/6/2013 2. Provide sample history of cow metabolism study (46708514). 1/31/2009 47689304 Satisfied 2/24/2009 Fluopicolide RD 1/28/2008 3. Provide storage stability, clarify identification of peaks, correct flowchart for fat, recalculate the radioactivity levels for the cow metabolism study (46708518). 1/31/2009 47689305 Satisified 2/24/2009 4. Provide sample history of the hen metabolism study (46708515). 1/31/2009 47689303 Satisfied 2/24/2009 5. Provide stability data for the duration of the storage period for the hen metabolism study (46708519). 1/31/2009 47689306 Satisfied 2/24/2009 6/1/2015 19 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 1. Field accumulation in rotational crops;cotton, canola, cereal grains (except rice), and soybean 12/1/2015 49006009 49006008 49006010 In review due date extended to 12/1/2015 Fluopyram RD 2/2/2012 2. 90 day inhalation 4/30/2012 48828300 waiver requested Waived 6/19/2012 3. Seedling emergence, tier II for buckwheat. 12/1/2012 48934301 In review 9/13/2012 1. Additional information (definitive identification of the test substance, spleen weights at necropsy, and competence of the laboratory to perform this type of assay) that will potentially allow upgrade of the assessment of the mouse subacute immunotoxicity study 6/30/2006 48692105 Satisfied 12/14/2011 2. Additional data concerning the chromatograms and chromatography from the qoat metabolism study 6/30/2006 46925801 Satisfied 9/1/2006 3. Proposed enforcement method, including instructions for the analysis of all crops and their associated processed commodities for which the petitioner is requesting tolerances 6/30/2006 46486101,46925803, 46486102 Satisfied 9/1/2006 4. Residue enforcement method livestock 6/30/2006 46486101 46486102 46925803 Satisfied 3/3/2005;09/01/20 06 5. Additional information and confirmatory raw data for the residue storage stability study 6/30/2006 46925801 Satisfied 9/1/2006 6. Summary information concerning the weather conditions for the growing season for each crop field residue trial 6/30/2006 46925801 Satisfied 9/1/2006 7. New peanut processing study 9/20/2007 47588901 Satisfied 11/6/2008 8. Analytical reference standards for Fluoxastrobin, itsZ-isomer, a metabolite, several deuterated molecules 6/30/2006 analytical reference standards are available Satisfied n/a Fluoxastrobin RD 9/20/2005 9. Summary information concerning the weather conditions for the growing season for each field rotational crop residue study 6/30/2006 46925801 Satisfied 9/1/2006 10. Soil characteristics data for each field rotational crop trial from which samples were analyzed 6/30/2006 46925801 Satisfied 9/1/2006 11. Explanation of why samples from one of the grass forage and hay rotational crop field trials appears to have been harvested more than one year after planting of the grass corp 6/30/2006 46925801 Satisfied 9/1/2006 12. One acute (10-day) sediment toxicity test 6/30/2006 45865506 (unacceptable), 46925805 (waiver request) In review 2/4/2003, 9/1/2006 Waiver request 13. One chronic (28-day) sediment toxicity test 6/30/2006 45865505 (unacceptable), 46404901 (supplemental), 46925805 (waiver request) In review 2/4/2003,11/16/20 04, 9/1/2006 Waiver request 14. Upgrade for anaerobic aquatic metabolism and one of the aerobic aquatic metabolism studies 6/30/2006 46925806 Satisfied not found 15. Upgrade for the 96-hour rainbow trout acute toxicity study of deqradate HEC 7180 9/30/2006 46925805 Satisfied 9/1/2006 16. Upgrade for the 96-hour sheepshead minnow acute toxicity studv 9/30/2006 45865417,46925805 Not Satisifed 2/4/2003, 9/1/2006 6/1/2015 20 of 35 ------- Chemical Division Reft Notice Date Conditional Data Requirement(s) MRID for Studv Review Status Date Data I Due Date - . .... 1. immunotoxicity study 4/29/2015 48360301;48360302; 48360303 Satisfied 1/21/2011 Conditional Data requirement satisfied: Aqency accepted study- 3/29/2011 2. Storage stability data for flutriafol and/or its metabolites in/on livestock and soybean commoditites 4/29/2015 47959201,47606601, 46568301 Satisfied 9/4/2012, 7/17/2013 Flutriafol RD 4/29/2010 3. A confined rotation crop study conducted with [triazole-3,5-14C] flutriafol and [carbinol14C] flutriafol 4/29/2015 47732601 47675601 47659101 Satisfied 4/22/2009 2/13/2009 1/30/2009 4. small scale prospective ground water monitoring study 4/29/2015 48735801,48769301, 48838501 Pending 2/2/2012, 3/13/2012, 4/4/2012 Protocol review completed 5. Avian acute oral LD50 study with passerine birds 4/29/2015 48586401 waiver denied Pending 8/26/2011 Protocol review completed; new study expected 4/29/15 1. Fish early life staqe study 3/27/2004 46241301 Satisfied 4/5/2004 2. Seed germination/seedling emergence study conducted using the end-use product 3/27/2004 45483801 Satisfied 8/24/2001 3. Vegetative vigar study conducted using the end-use product 3/27/2004 45483802 Satisfied 8/24/2001 Foramsulfuron RD 3/27/2002 4. Tier II aquatic plant growth study conducted using the end-use product 3/27/2004 45109911 Satisfied 4/3/2000 5. Submit an acceptable study to complete the data requirement as specified in the Confidential Attachment to the Registration Notice. 3/27/2004 45554701; 45562501;45562501; 45562502 Satisfied 4/8/2002 1. Aquatic Algal Species 12/31/2006 46753501,46753502, 46753503, 46753504 Satisfied 2/8/2006 Forchlorfenuron RD 9/30/2004 but reg notice dated 2/2/2005 2. Vegetative Vigor Study 12/31/2006 46753505 Overdue 2/8/2006 Study Supplemental; waiver denied, Requirement partially satisfied; Company notified that a new study is needed. 3. Field Dissipation Study 1/15/2007 waiver requested Waived 4/5/2005 4. Avian Chronic Study 1/15/2007 Waiver requested. In Review N/A EFED Review expected 4/2015 Waiver requested and denied; rebuttal submitted and in review. Avian reproduction study in review 1. The final report of the 3 year storage stability data for tomato 12/30/2008 45866701 Satisfied 8/24/2009 2. Tobacco storage stability study (data depicting frozen storage stability of foshiazate and ASC- 67131 in a representative foliage commodity 12/30/2008 45866701 (tomato) and 45866705 (tobacco) Satisfied 2/27/2003 Registrant submitted the studies prior to registration in response to the Agency's residue chemistry review of 8/27/2002. 3. Analytical grade reference standards for the foshiazate metabolite ASC-67131 must be submitted to the EPA standards repository 12/30/2008 No MRID No. Satisified N/A Sample shipped to EPA's standards repository on 12/6/2004 Fosthiazate RD 3/30/2004 4. Additional data to characterize insoluble residues in 30 days after treatment (DAT) rotated wheat commodities 12/30/2008 Waived 8/24/2010 Required only for a pending use that was not registered. 5. Storage stability data to support the additional analyses required on the 30-DAT wheat forage, straw, and grain 12/30/2008 Waived 8/24/2010 Required only forpending use that was not registered. 6. 28-day inhalation study in rats with foshiazate 12/30/2008 46744901 Satisfied 1/30/2006 7. Developmental neurotoxicity (DNT) study in rats with comparative ChE measurements in adults and pups 12/30/2008 46784301 waiver requested and granted Waived 5/15/2006 8. A worker study for activities involving contact ith treated soil conducted concurrently with a soil residue dissipation studv. 12/30/2008 47098901 waiver request Waived 4/2/2007 Agency did additional risk assessments and concluded MOEs are adequate. Requirement withdrawn. 6/1/2015 21 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 1. 28-dav dermal toxicity study no date specified 46917201 Satisfied 8/21/2006 Furfural RD 10/5/2006 2. Guideline 28- or 90-day inhalation study no date specified 46917202,47419101, 46426505 Satisfied 8/21/2006, 5/19/2008 3. Field/greenhouse volatility study for each major application method no date specified 47253701 Satisfied 10/11/2007 4. Dislodqeable foliar residue study no date specified 47146202 Satisfied 6/19/2007 1. immunotoxicity study 12/14/2012 48691003 Satisfied 12/12/2011 2. Multiresidue Methods 12/14/2012 49019000 In Review 12/17/2012 3. Storage stability for rice, grain, peppers, tomatoes. 12/14/2012; extended to 4/30/2013 49114902 In Review 4/30/2013 4. Confined Accumulation in Rotational Crops 12/14/2012 48691001 Satisfied 12/12/2011 Imazosulfuron RD 12/14/2010 5. Field Accumulation in Rotational Crops 12/14/2012 6/30/2014 extension granted until 6/30/2014 12/17/2012 6. Acute toxicity study addressing effects of degradate, ISPN, to fish, quatic invertebrates, and aquatic non-vascular plants. 12/14/2012 49019001,49019002, 49019003,49019004, 49019005,49019006 All studies accepable except 4901003 (new study required) 12/17/2012 7. Acute Avian Oral Toxicity Study 12/14/2012 48691002 In Review 12/12/2011 1. Product identity and composition 1/30/2002 45591501 Satisfied 1/30/2002 2. Description of materials used to produce the product 1/30/2002 45591501 Satisfied 1/30/2002 3. Description of production process 1/30/2002 45591501 Satisfied 1/30/2002 4. Description of formulation process 1/30/2002 45591501 Satisfied 1/30/2002 5. Discussion of formation of impurities 1/30/2002 45591501 Satisfied 1/30/2002 6. Developmental neurotoxicity study in the rat 10/30/2002 46749001,46749002, 46749003 Satisfied 2/2/2006 7. 90-day inhalation toxicity study in the rat 10/30/2002 45354001 Satisfied 2/2/2006 8. Poultry feedinq study 10/30/2002 46114302 Satisfied 11/6/2003 9. Confirmatory method for plants 10/30/2002 45795818 Satisfied 11/4/2002 Indoxacarb RD 9/29/2000 10. Specificity testing for analytical methods for plants 10/30/2002 45795818 Satisfied 11/4/2002 11. Storage stabiliry data reflecting the maximum frozen storage intervals of cotton processed samples 10/30/2002 45795819 Satisfied 11/4/2002 12. Photodeqradation in water 10/30/2002 45795802 Satisfied 11/4/2002 13. Hydrolysis 10/30/2002 45795801 Satisfied 11/4/2002 14. Aerobic soil metabolism 10/30/2002 45795803, 45906701 Satisfied 11/4/02, 4/11/03 15. Anaerobic aquatic metabolism 10/30/2002 45795804 Satisfied 11/4/2002 16. Aerobic aquatic metabolism 10/30/2002 45793301 Satisfied 10/31/2002 17. Leaching-adsorption/desorption 10/30/2002 45795805, 45795806, 45795807, 45795808, 45906702 Satisfied 11/4/02, 4/11/03(..702) 18. Terrestrial field dissipation 10/30/2002 45795810,45795811 Satisfied 11/4/2002 19. Accumulation in fish 10/30/2002 45805301 Satisfied 11/22/2002 lodomethane RD 10/5/2007 Agency does not request any additional conditional data in req. notice no additional data required N/A N/A N/A 1. Avian reproduction studies 12/31/2004 46431803 Satisfied 12/27/2004 2. Freshwater fish early-life staqe studies 12/31/2004 46431804 Satisfied 12/27/2004 3. Estuarine invertebrate life-staqe studies 12/31/2004 48288301 Satisfied 11/5/2010 4. Carcinogenicity study in mice 12/31/2004 Waiver requested Waived 1/4/2008 waivers found acceptable within HED risk assessment (D350046) 5. Developmental toxicity study in rabbits 12/31/2004 Waiver Requested Waived 1/4/2008 waivers found acceptable within HED risk assessment (D350046) iodosuifuron- methyl-sodium 6. 28-day inhalation study 12/31/2003 Waiver requested Waived 1/4/2008 waivers found acceptable within HED risk assessment (D350046) RD 10/26/2002 7. 21-day dermal study 12/31/2003 Waiver requested Waived 1/4/2008 waivers found acceptable within HED risk assessment (D350046) 6/1/2015 22 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) 12/31/2004 MRID for Studv Review Status Date Data Comments N/A Received , > - r- 8. Analytical methods in plants, soil, and water. N/A N/A For this requirement, the regsitrant understood in a meeting with the Agency on 4/9/2003 that the requirement was placed in reserve pending consultation with industry working groups on ways to address the requirement. This chemical is currently in registration review and this required is included in the DCI. Ipconazole RD 9/10/2004 1. 28-dav dermal toxicity study in rats 4/30/2006 47048916 Satisfied 5/15/2006 2. 90-day inhalation toxicity study in rats 4/30/2006 47048915 Satisfied 4/19/2005 3. Additional soil adsorption/desorption study conducted in a low orqanic matter (OM) soil 4/30/2006 46827503 Satisfied 5/15/2006 4. In vivo cytoqenic assay 4/30/2006 46827502 Satisfied 5/15/2006 Macleaya Extract RD 9/19/2002 1. 90-day dermal study in the rabbit 3/31/2004 46273804 Waived 5/18/2004 Study called in under Registration Review Data Call-in Notice issued 6/12/2012. HAZPOC waived 2. 90-day inhalation in rats 3/31/2004 46273806 Waived 5/18/2004 Study called in under Registration Review Data Call-in Notice issued 6/12/2012. HAZPOC waived 3. Developmental study in the rabbit 3/31/2004 46273807 Waived 5/18/2004 Study called in under Registration Review Data Call-In Notice issued 6/12/2012. HAZPOC waived 4. Mutagenicity battery (gene mutation in bacteria) and mammamalian cells, and an in vivo cytogenetics assay 3/31/2004 46273814, 46273811, 46273812 Satisfied 5/18/2004 Study called in under Registration Review Data Call-in Notice issued 6/12/2012. Mammalian Gonadotropin Releasing Hormone RD 9/29/2009 1. Guideline 830.1700 Preliminary analysis and validation of the method of analysis of the formulation 9/29/2010 48623801 Satisfied 9/29/2011 2. Guideline 830.1750 Certified Limits (basic and alternate CSFs) 9/29/2010 48959701 Satisfied 10/1/2012 Mandipropamid RD 1/9/2008 1. New chronic daphnia study 1/9/2009 47802601 Satisfied 7/14/2009 2. Storage stability data for SYN 500003 which covers the entire 32 months of storage (interim storage stability data for six months were submitted) 1/9/2009 47642303 In Review 1/12/2009 Mesosulfuron- methyl RD 3/31/2004 1. One year storage stability and corrosion characteristics 10/1/2005 46647101 Satisfied 9/19/2005 2. Independent laboratory validation of the livestock enforcement method for mesosulfuron- methyl in ruminant liver 10/1/2004 48080501 Satisfied 4/30/2010 3. Storage stability data to demonstrate the stability of mesosulfuron-methyl residues in/on wheat forage stored frozen for up to 26 months and in/on wheat grain and straw stored frozen for up to 25 months 10/1/2005 46229001, 46229002, 46229003, 46229004 In Review 5/22/2004 4. Tier II vegetative vigor study with Osprey herbicide 10/1/2005 46688201 In Review 11/14/2005 5. Terrestrial field dissipation study with Silverado Wild Oat herbicide in a spring wheat area such as North Dakota. 10/1/2006 46948901 In Review 10/3/2006 6. Avian-reproduction study (mallard duck) 4/2/2006 Waiver requested Waived 3/30/01, 10/28/04 6/1/2015 23 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- Received 7. Independently validated analytical chemistry methods to identify and quantify residues of mesosulfuron-methyl and its degradates in water (must be sufficiently sensitive to adequately determine and characterize mesosulfuron-methyl residues in water resources down to levels of ecotoxicological importance) 4/2/2005 46451701, 46451702 Supplemental 1/24/2005 Addressed in Reg Review DCI 1. Developmental neurotoxicity study in the mouse. 6/4/2005 45651812 Waived 3/28/2002 2. Adequate storage stability data in the plant and livestock metabolism studies 6/4/2005 45651814 Waived 3/28/2002 3. Revised interference study 6/4/2005 45651816 Waived 3/28/2002 Mesotrione RD 6/4/2001 4. 28-day Inhalation study 6/4/2005 46562908 waiver requested Waived 6/27/2005 5. Phytotoxicity studies 6/4/2005 47093501 Satisfied 3/20/2007 6. Improvement in the extraction method in the soil analytical method 6/4/2005 45651815 Satisfied 7. A prospective groundwater monitoring study at a vulnerable site in the southern US. 6/4/2005 47418901 Satisfied 5/7/2008 Metaflumizone RD 4/30/2007 1. Storage and corrosion characteristics 10/30/2008 47267901 Satisfied 10/30/2007 1. Bi-valve mussel bioaccumulation study 6/30/2002 45702704 Satisfied 2. Frog embryo teratogenesis assay using Xenopus laevis 6/30/2002 48661701 In review 3. Sub-acute sediment study usinq Hexaqenia 6/30/2002 45702703 In Review Methoxyfenozide RD 7/5/2000 4. Chronic Sediment Study using Chinonomus riparius 6/30/2002 45032801 In review 5. Honey Bee Brood Studies 6/30/2002 45065501; 48350501; 48962201; 48962202; 48962203 In review Metofluthrin RD 9/29/2006 1. Fish toxicity bluegill study 9/29/2008 47414002 Satisfied 4/30/2008 2. Honey bee acute contact 9/29/2008 47046301, 47414001 Satisfied 2/2/07, 4/30/08 1. Immunotoxicity study needed for future uses 11/30/2012 48981302 Satisfied 11/13/2012 2. Method validation data must be submitted for Method FAMS 105-01 reflecting fortifications at 4.5 ppm for grapes, and at both the LOQ (0.05 ppm) and 17 ppm for raisins. 11/30/2012 48981303, 48981304 Satisfied 11/13/2012 3. Radiovalidation for method FAMS 105-01 to demonstrate recovery of weathered residues of metrafenone from grapes. Cucumber data may be submitted in lieu of grapes if the data show adequate extractibility by 9:2 n-heptane/acetone. 11/30/2012 48981305-8 Satisfied 11/13/2012 Metrafenone RD 11/24/2010 4. Radiovalidation data are required to support the data collection method, BASF Method 535/0. Samples from the cucumber metabolism study currently in progress may also be used to generate these data. 11/30/2012 48981305-8 Satisfied 11/13/2012 5. Avian acute oral with passerine birds 11/30/2012 48981309 Satisfied 11/13/2012 6. Acute tox freshwater fish 11/30/2012 48981310 Satisfied 11/13/2012 7. Chronic freshwater fish early-life stage 11/30/2012 48981311 Satisfied 11/13/2012 8. Chronic aquatic freshwater invertebrate life- cycle 11/30/2012 48981312 Satisfied 11/13/2012 9. Acute marine/estuarine invertebrate 11/30/2012 48981313 Satisfied 11/13/2012 10. Aquatic vascular plant growth Tier II 11/30/2012 48981314 Satisfied 11/13/2012 11. Aquatic non-vascular Tier II 11/30/2012 48981315-21 Satisfied 11/13/2012 6/1/2015 24 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 12. Chronic freshwater invertebrate whole sediment on TGAI for Chironomus dilutus 11/30/2012 48981320-22 Satisfied 11/13/2012 13. Storage stability and corrosion characteristics 11/30/2012 48981301 Satisfied 11/14/2012 1. Acute inhalation toxicity (technical)- rat (not upqradable-must be repeated) 5/29/2004 N/A Cancelled N/A Voluntarily cancelled. 2. 28-day dermal toxicity-rabbit (not upgradable- must be repeated) 9/29/2005 N/A Cancelled N/A Voluntarily cancelled. 3. Prenatal developmental toxicity-rabbit (possibly upqradable) 9/29/2005 N/A Cancelled N/A Voluntarily cancelled. 4. Prenatal development toxicity- rat (possibly upqradable) 9/29/2005 N/A Cancelled N/A Voluntarily cancelled. Milbemectin RD 9/29/2003 5. Multigeneration reproductive toxicity-rat (possibly upqradable) 9/29/2007 N/A Cancelled N/A Voluntarily cancelled. 6. Estuarine fish early life-stage- sheepshead minnow 9/29/2004 N/A Cancelled N/A Voluntarily cancelled. 7. Estuarine invertebrate life-staqe- mysid 9/29/2004 N/A Cancelled N/A Voluntarily cancelled. 8. Aquatic acute sediment toxicity testinq 9/29/2004 N/A Cancelled N/A Voluntarily cancelled. 9. Anaerobic aquatic metabolism (possibly upqradable) 9/29/2005 N/A Cancelled N/A Voluntarily cancelled. 10. Bioconcentration in fish (possibly upqradable) 9/29/2005 N/A Cancelled N/A Voluntarily cancelled. Nicarbazin RD 11/23/2005 1. Storage stability and corrosion characteristics studies 11/23/2006 46416408 Satisfied 1/12/2005 1. 90-day inhalation toxicity study in rats 9/25/2003 Waiver requested Waived N/A Novaluron RD 9/25/2001 2. Two mutagenicity studies: In vitro mammalian cell gene mutation and in vivo cytogenetrics assay 9/25/2003 45638321,45638222 Satisfied 3/22/2002 1. Results of one year storage stability and corrosion characteristics no date specified 46712101 In Review 12/16/2005 2. Analytical reference standard to the National Pesticide Standards Repository no date specified sample(s) received on 6/25/08 Satisfied sample(s) received on 6/25/08 Sample expires on 4/1/17 Orthosulfamuron RD 2/22/2007 3. Dates of sample extraction, initial TLC analysis, and metabolite identification analyses in order to determine sample storage intervals for the submitted goat metabolism study. (If the initial quantitative TLC analyses were conducted within 6 months of sample collection, then supporting storage stability data will not be required) no date specified information provided in letter dated 9/27/07 Satisfied information provided in letter dated 9/27/07 4. Radiovalidation data (using samples from the rice metabolism study) for the method chosen for tolerance enforcement purposes no date specified 47030001 In Review 1/16/2007 5. Recovery data using specific directions for each multiresidue method used by FDA no date specified 47674201 In Review 2/12/2009 Penoxsulam RD 9/27/2004 1. Seed germination/seeding emergence studies, vegetative vigor studies, and an aquatic plant growth study using Duckweed with the degradates, BSA, 2-amino-TP, TPSA, BSTCA methyl, BSTCA, 2-amino-TCA, 5-OH- penoxsulam, SFA, sulfonamide, 5, 8-di-OH and 5-OH 2 amino TP no date specified 46758301, Exhibit A in 46758300 Satisfied 2/13/2006 2. Test terrestrial plants using the liquid and end- use products of penoxsulam. no date specified 46930301,46930302 Satisfied 2/13/2003 6/1/2015 25 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 3. Enforcement method revised as recommended in the Analytical Chemistry laboratory memo dated 9/17/2004 no date specified 46389701 Satisfied 10/26/2004 4. One year storage stability and corrosion characteristics no date specified 46433901,46433902, 46449901 Satisfied 12/28/04, 12/28/04, 1/24/05 Picaridin 12/7/2000 1. 5 week oral toxicity study in rats 4/15/2001 45387901 Satisfied 12/1/2002 2. 14 week oral toxicity study in rats. 4/15/2001 45387902 Satisfied 12/1/2002 RD 3. Submit the protocol and locations for conduct of the 2001 market test for 2000 human subjects. 3/1/2001 Correspondence - no MRID assigned Satisfied 2/28/2001 4. Submit the results of the marketing test with up to 2000 subjects. 12/1/2001 Correspondence - no MRID assiqned Satisfied 9/27/2001 Additional validation data for pinoxaden and M2 residues in livestock commodities not specified 47293207 Satisfied 11/30/2007 Storage Stability Data for Rotational Crops in barley for 15 months and wheat for 6 months. not specified 47293208 Satisfied 11/30/2007 Fish acute toxicity tests required for parent pinoxaden to replace supplemental studies not specified 47293202 In Review 11/30/2007 Freshwater invertebrate acute toxicity study for parent pinoxaden to replace an unacceptable study not specified 47293210 In Review 11/30/2007 Estuarine/marine fish acute toxicity test using parent pinoxaden to replace a supplemental study not specified 47293210 In Review 11/30/2007 Estuarine/marine shrimp acute toxicity test is required using parent pinoxaden to replace a supplemental study. not specified 47293201 In Review 11/30/2007 Freshwater fish early life-stage study using parent pinoxaden not specified 47293210 In Review 11/30/2007 Freshwater invertebrate life-stage study required using pinoxaden not specified 47293210 In Review 11/30/2007 Avian dietary studies in mallard duck and bobwhite quail for the formulated product with adjuvant not specified 47293210 In Review 11/30/2007 Pinoxaden RD 7/27/2005 Acute fish toxicity for the degradate NOA-407854 on warm water species only, for the degradate NOA-447204 on warm water and cold water species, and for the formulated product with adjuvant on warm water and cold water species not specified 47293210 In Review 11/30/2007 Freshwater invertebrate life-cycle studies for the degradate NOA-447204 and formulated product with adjuvant not specified 47293210 In Review 11/30/2007 Marine-estuarine shell deposition studies for the degradates NOA-407854 and NOA-447204. not specified 47293210 In Review 11/30/2007 Freshwater fish early life-stage studies for the degradate NOA-407854, and the degradate NOA 447204 not specified 47293210 In Review 11/30/2007 Freshwater invertebrate life-cycle studies for the degradate NOA-447204, and for the degradate NOA -407854 to replace a supplemental study. not specified 47293210 In Review 11/30/2007 Seedling emergence and vegetative vigor studies for each of the two main degradates NOA-407854 and NOA-447204 not specified 47293204,47293205, 47293206 In Review 11/30/2007 6/1/2015 26 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Tier II Aquatic plant growth studies for the parent pinoxaden, degradates NOA-407854 and NOA- 447204, and for the formulation with adjuvant not specified 47293210 In Review 11/30/2007 830 Series subgroup A required for the pinoxaden technical produced on a commerical scale. not specified 46701301 Satisfied 11/30/2007 Prohexadione Calcium RD 4/26/2000 1. Storage stability on the processed commodities of peanuts 4/30/2001 45190501 waiver requested Waived 8/16/2000 2. 21-dav dermal toxicity study in rabbits 10/31/2001 45430301 Satisfied 6/18/2001 Propoxycarbazon e-sodium 1. Additional storage stability data for mustard greens and turnips to validate the submitted field rotational crop study 6/30/2006 46874601 Satisfied 6/30/2006 RD 6/30/2004 2. Study monitoring of "carboxylic acid" degradate to determine if it is accumulating in ponds, lakes and reservoirs near propoxycarbazone use areas 6/30/2006 46365701 waiver request Waived 9/20/2004 waiver granted 4/26/2005 1. Developmental neurotoxicity study, brain morphometric measurements from the mid and low dose animals, also addressing the other deficiencies listed in the DER to allow the reconsideration of the FQPA database uncertainty factor 12/1/2007 47293901 Satisfied 12/3/2007 2. Final report of the ongoing storage stability study with prothioconazole and desthioprothioconazole in plant commodities 3/31/2008 47408201 Satisfied 4/21/2008 3. Poultry feeding study with prothioconazole 6/30/2008 47492801 Satisfied 7/30/2008 4.Data to confirm the degree of stability of the prothioconazole-4-hydroxy in ruminant fat for a duration of 45 days. 12/1/2007 47107801 Satisfied 4/17/2007 5. Analytical reference standards for the following compounds: prothioconazole-desthio, prothioconazole sulfonic acid potassium salt, prothioconazole 7/1/2007 N/A Satisfied 4/4/2007 Prothioconazole RD 3/27/2007 6. Raw data from field fortifications in MRID 46246447 (in addition to the percent conversions reported in the study) 12/1/2007 47337401 Satisfied 2/15/2008 7. Proposed data collection and enforcement methods for livestock commodities must be be validated for poultry commodities. The EPA labs validated the livestock method for liver and milk. If the poultry method is the same or essentially the same, then the registrant at a minimum must present an argument and confirm (in writing) that the cow liver LOQ covers chicken liver. At a max, the registrant must validate the method for poultry commodities, including a demonstration of the LOQs. 6/30/2008 47492801 Satisfied 7/30/2008 8. Repeat sediment toxicity study using chironomids following Agency guidelines in which the chemical is first added to the sediment 12/1/2007 47626901 Satisfied 12/17/2008 1. Anaerobic Soil Metabolism 12/30/2000 N/A Cancelled N/A There are no active registrations. All reqistrations cancelled 2. Anaerobic Aquatic Metabolism 12/30/2000 N/A Cancelled N/A There are no active registrations. All reqistrations cancelled 6/1/2015 27 of 35 ------- PT807-HCI 12/30/1999 3. Aged Leaching 4. Terrestrial Field Dissipation 5. Developmental Rat Neurotoxicity study 10/30/2001 6/30/2001 12/30/2000 t R. .ii 'li.itinn Statue ID for S Date Data Chemical Division ReĢ Notice Date Review Status Comments N/A N/A N/A Cancelled Cancelled Cancelled N/A N/A N/A There are no active registrations. All registrations cancelled There are no active registrations. All registrations cancelled There are no active registrations. All registrations cancelled Pyraclostrobin RD 9/30/2007 1. Annually by December 31 of each year and beginning in 2003, report percent crop treated data for pyraclostrobin for each crop pyraclostrobin is sold for use on. annually BASF submitted PCT data in December of each year, beginning in 2003 through 2010 Satisfied 2. 2 year chronic toxicology study in rats must be submitted for female rats. The primary deficiency in the results for female rats in the study previously submitted is that the highest dose was well below the sub-chronic maximum dose and there were no significant treatment- related toxicological effects. 9/30/2006 3. 18-month carcinogenicity study in mice must be submitted for female rats. The primary deficiency in the results for female mice in the study previously submitted is that the highest administered dose was well below the subchronic maximum tolerated does and there were no significant systemic treatment-related toxicological effects of the dosing. BASF submitted additional supporting data in 2/1/2002 in advance of the registration decision. 45596201 and 45596202-45596206 (supplemental information) Satisfied 9/30/2006 46678201 Satisfied 4. 2 generation repro study in rats; primary deficiencies in the study previously submitted are that there were no adverse, treatment-related maternal, reproductive, or offspring effexts at the highest dose tested, and the limit dose was not approached. 9/30/2005 45596210 submitted in advance of the registration decision Satisfied 5. 28 day dermal toxicity study in rats 9/30/2004 6. 28 day inhalation study in rats 9/30/2004 45596201 submitted in advance of the registration decision Satisfied 46638801 Satisfied 7. Aerobic aquatic metabolism study 9/30/2005 rebuttal submitted 45826701 Satisfied 8. Acute aquatic toxicity of pyraclostrobin degradates BF 500-3 and BF 500-6 to freshwater fish 9/30/2005 46164001,46164002, 46164003 Satisfied 9. Acute aquatic toxicity of pyraclostrobin degradates BF 500-3 and BF 500-6 to freshwate invertebrates 9/30/2005 46164001,46164002, 46164003 Satisfied 10. Acute aquatic toxicity of pyraclostrobin degradates of BF 500-3 and BF 500-6 to freshwater green '< 9/30/2005 46164001,46164002, 46164003 Satisfied 11. Acute toxicity of pyraclostrobin to sediment- dwelling organisms 9/30/2005 49080401,49080402 (45826705,46164003) Satisfied 12. Mysid life-cycle study 9/30/2005 1/31/2014 46227601 (supplemental); 49302901 Satisfied 13. Avian acute toxicity study using the formulated product Headline EC 9/30/2005 45826702 Satisfied EPA informed BASF on March 23,2011 (via email) that PCT data is no longer required 2/1/2002 EPA upgraded study to acceptable for both male and female rats 9/10/2003 10/27/2005 EPA report from CARC of 2/15/2007 indicates data requirement has been satisfied 2/1/2002 Original study upgraded to acceptable in HIARC memo of 2/10/2003 2/1/2002 Original study upgraded to acceptable in HIARC memo of 2/10/2003 9/6/2005 12/18/2002 12/29/2003 waiver request requested and reviewed 12/29/2003 waiver request requested and reviewed 12/29/2003 waiver request requested and reviewed 3/11/13 (12/29/2003) EPA classified the studies that were received in 2003 as supplemental; new studies were received on 3/11/2013 01/23/2014; 3/17/2004 Satisfied - 49302901 Supplemental (46227601) 12/18/2002 6/1/2015 28 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data I Que Date MmmmimmMmmMimkmmmmaMMM , > - r- ^ 1 ģ i, , i Submitted , ! ' , ' 1 1 Received 14. Fish acute toxicity study using the formulated product Headline EC 9/30/2005 4/1/2015 45826703, 45826704 Not Satisfied 12/18/2002 Study was conducted according to OECD guidelines ut classified as invalid in a review dated 2/10/2005. A waiver request was submitted on 8/29/2013. The waiver request was denied for the studies on the formulation but studies were submitted on the technical and are under review. Letter sent denying waiver and requesting a new study be submitted. New study due 4/1/2015. 15.Modify tolerance enforcement methods for determination of pyraclostrobin and it desmethoxy metabolite in or on plant commodities - the LC/MS/MS method D9808 and the HPLC/UV method D9904 to include any modifications made by the EPA laboratory during the Agency laboratory validation. within 3 months of BASF's receipt of the methods from the Agency 46710001 Satisfied 12/7/2005 16.Modify tolerance enforcement methods for determination of residues of pyraclostrobin in or on ruminant commodities - the HPLC/UV metho 439/0 and the HPLC/UV method 446 to include any modifications made by the EPA laboratory during the Agency laboratory validation. within 3 months of BASF's receipt of the methods from the Agency 46710001 Sstisfied 12/7/2005 17.Data to support storage conditions of milk and fat tissue samples from ruminant study 9/30/2004 45765401 Satisfied 9/25/2002 Supported HED memo - 7/26/2004 18. Study confirming that rotational crop samples were analyzed within the interval represented by the storage stability study must be submitted. 9/30/2004 46469501 Satisified 2/9/2005 1. Photolysis in water using pyraflufen-ethyl and all possible transformation products 12/31/2003 46162701, 46162702 Satisfied 12/31/2003 2. Avian reproduction studies 12/31/2003 46447901 Satisfied 1/18/2005 Pyraflufen-ethyl RD 9/27/2002 3. Phototoxicity fish early life stage study using transformation product E-1 and transformation product E2. 12/31/2003 48409701 Satisfied 3/2/2011 4. 28-day Inhalation study 12/31/2003 48381204 Satisfied 2/10/2011 5. Preliminary analysis (830.1700) conducted in compliance with the GLP requirements of 40CFR160. 12/31/2003 46162701 Satisfied 12/31/2003 1. Storage stability and corrosion characteristics studies 8/9/2008 47309101 Satisfied 12/27/2007 2. In vivo dermal penetration study 8/9/2009 47860001 Satisfied 9/18/109 3. Revisions to the analytical methods 8/9/2009 47806401 Satisfied 7/17/2009 Pyrasulfotole RD 8/9/2007 4. Analytical reference standard for pyrasulfotole, pyrosulfotole-desmethyl and labeled internal standards to the EPA National Pesticide Standards Repository 8/9/2009 47806401 Satisfied 7/17/2009 5. Toxicity of residues in sediment to benthic organisms (freshwater and marine) 8/9/2009 47552401 Satisfied 9/29/2008 Pvridalvl RD 4/24/2008 1. Dissociation Constant no date specified 47664701 Satisfied 2/3/2009 Pyroxsulam RD 2/27/2008 1. One year storage stability and corrosion characteristics studies 2/27/2009 47711901 Satisfied 3/25/2009 1. Dermal penetration 10/1/2004 47830401 47476901 Satisfied 3/2/2010 and 3/11/2009 2. 28-dav inhalation (rat) 1/1/2005 waiver requested Waived 4/1/2004 6/1/2015 29 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received Quinoxyfen RD 9/30/2003 3. Avian reproduction study with the mallard duck for parent and metabolite 10/1/2005 45360412 waiver requested for parent; 48991801 study for metabolite. waiver granted for parent; requirement satisfied for metabolite. 3/25/2004;11/12/2 012 Waiver granted for parent; study held in reserve for the metabolie until a method was developed. 4. Chronic Toxicity (Marine/Estuarine Fish and Invertebrates) 1/2005;6/2015 48102301,48102302 Not Satisfied 5/21/2010 new study due 6/2015 5. Acute Avian Reproduction 7/1/2004 47783301 waiver requested Requirement withdrawn 4/28/2005 6. Acute Oral (rat) 7/1/2004 46360401 Satisfied Saflufenacil RD 9/3/2009 1. Fish early life-stage toxicity with modified lighting for LDPH chemicals no date specified N/A Requirement withdrawn N/A This is no longer a requirement for this chemical. Three ai's were chosen to submit the study, and this was not in that group. The data received supported EFED's earlier conclusions regarding LDPH phototoxicity, so no further information is needed on this topic for saflufenacil at this time. 2. Immunotoxicity study no date specified 48233701 Satisfied 10/14/2010 Acceptable; review completed 3/30/11 3. One year storage stability and corrosion characteristics no date specified 47913803 In Review 4/27/2010 Still in review with RD/TRB under DP 378571 4. 830 series group A data (including a revised basic CSF) for the BAS 800H TGAI/MUP when the product is produced on commercial scale no date specified 47913802 48445701 Satisfied 4/27/2010 Still in review with RD/TRB under DP 378571 1. Successful PMV of plant and livestock enforcement methods 3/28/2008 48875802 Satisfied 29-Jun-12 2. Poultry feeding study 3/28/2009 47396302 waiver requested waiver granted 4/9/2008 3. Processing studies 9/28/2009 47453501 Satisfied 20-Jun-08 4. Analytical reference standards 3/28/2008 48875802 Satisified 29-Jun-12 5. Acute freshwater invertebrate 6/28/2008 47359202,47359203 Satisfied 2/29/2008 Spinetoram RD 9/28/2007 6. Oyster acute toxicity test (shell deposition) raw data or new study 6/28/2008 47359201 Satisfied 2/29/2008 7. Acute estaurine/marine fish 9/28/2009 47767601 Satisfied 6/3/2009 8. Acute freshwater fish 9/28/2008 47902003, 47902004 Satisfied 11/3/2009 9. Mysid chronic toxicity test 2/28/2009 47790501 Satisfied 6/30/2009 10. Whole sediment acute toxicity invertebrates, estuarine and freshwater 2/28/2009 47689701 Satisfied 2/27/2009 11. Honey bee toxicity of residues on foliage 2/28/2009 47689702 Satisfied 2/27/2009 12. 5-batch preliminary analysis data on this technical product produced on large or commercial scale, along with a revised CSF 12/31/2007 47306602,47306603, 48085901 Satisfied 12/18/17, 5/5/10- (901) 1. Details of the commercial scale production process for the TGAI/MUP for the facility located in Germany 6/30/2007 47024301 Satisfied 1/8/2007 2. 5-batch analysis for the TGAI/MUP batches produced on a commercial scale, also submit a revised basic formulation based on the 5- batches produced on a commercial scale 6/30/2007 47024301 Satisfied 1/8/2007 3. Apple (juice) and grape (juice) processing studies which monitor for residue of spirodiclofen 6/30/2007 47168602,47168601 Satisfied 7/2/2007 Spirodiclofen RD 6/30/2005 4. Additional morphometric analyses of the caudate putamen, parietal cortex, hippocampal gyrus, and dentate gyrus at the mid and low doses are required for both sexes in the developmental neurotoxicity studv 6/30/2007 47166501 Satisfied 6/28/2007 6/1/2015 30 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 5. Repeated freshwater fish acute toxicity study usinq blueqill sunfish 6/30/2007 Waiver requested waiver granted N/A 6. Repeated freshwater fish acute toxicity study usinq rainbow trout 6/30/2007 Waiver requested waiver granted N/A 7. Repeated freshwater invertebrate toxicity study usinq daphnia maqna 6/30/2007 Waiver requested waiver granted N/A 8. Repeated estuarine/marine acute toxicity - sheepshead minnow 6/30/2007 Waiver requested waiver granted N/A 9. Repeated estuarine/marine acute toxicity - mysid shrimp 6/30/2007 Waiver requested waiver granted N/A 1. Additional storage stability data for rotational crops 11/3/2007 47293301 Satisfied 5/18/2007 Spiromesifen RD 5/3/2005 2. Avian reproduction study using bobwhite quail and mallard duck 5/3/2007 47133101,47142201 Satisfied 11/30/07, 5/31/07 3. Chironomid sediment toxicity test 5/3/2007 47133102,47133103 Satisfied 5/18/2007 4. Chronic field test for pollinators 5/3/2007 47344401 Supplemental 2/12/2008 Requirement put on hold pending the development of a protocol. 5. Preliminary commercial scale 46825601 Satisfied 9/8/2006 1. New photodegradation on soil study, conducted on sterile soil 6/30/2009 47576501,47576502 Satisfied 10/22/2008 2. Soil taxonomy for the Saskatoon loam soil from Sasketchwan, Canada 12/30/2009 Letter Satisfied 1/09 3. Avian reproduction study with the mallard duck 6/30/2010 47757401,48968801 Satisfied 5/11/2009, 10/11/2012 6/30/2008 10/15/2010 4. Field testing for pollinators 6/30/2010 47576401,47563302, 47563303, 47563304, 47563305, 47563306, 47563307, 47563308, 47563309,47563310, 47563311,47563312 Satisifed 10/22/08 (first 2), 10/7/08 (the rest) Further testing may be required pending protocol development. Spirotetramat RD 5. Freshwater fish toxicity with fathead minnows 6/30/2009 47774301 Satisfied 6/10/2009 6. Avian oral toxicity study with passerine species 6/30/2009 47774302 Satisfied 6/10/2009 7. One year storage stability and corrosion characteristic studies 6/30/2009 48002901 Satisfied 3/3/2010 8. Full scale five-batch preliminary analysis of the technical material 6/30/2009 48525902,4852903, 48525904 Satisfied 7/1/2011 9. Avian Reproduction with Mallard Duck (required in 10/15/2010 decision) 10/15/2011 48958801 In Review 10/11/2012 lO.lmmunotoxicity (required in 10/15/2010 decision) 10/15/2011 48525901 Satisfied 7/1/2001 11. Subchronic neurotoxicity (required in 10/15/2010 decision) 10/15/2011 48958802 Satisfied 10/11/2012 1. Modify the confirmatory method to use more than single-ion monitoring or conduct an interference study 7/31/2005 N/A N/A N/A Products cancelled 5/23/2012. 2. Storage and stability data for the hops trials which were conducted in Germany 12/31/2004 N/A N/A N/A Products cancelled 5/23/2012. Storage stability for bananas frozen for 6 months 12/31/2004 N/A N/A N/A Products cancelled 5/23/2012. Spiroxamine RD 7/16/2004 3. Two-Generation Reproduction Study-Rat (Additional data to clarify lactation indices and clinical signs of toxicity in the second generation in the submitted study (if data is insufficient to upgrade study, a new two-generation reproduction study must be submitted with any future new uses) 12/30/2004 N/A N/A N/A Products cancelled 5/23/2012. 6/1/2015 31 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- ' .. i >. . . Received 4. Adsorption/Desorption study with soils from hop-qrowinq areas 9/30/2005 N/A N/A N/A Products cancelled 5/23/2012. 5. Freshwater fish (Blueqill sunfish)-Acute 9/30/2005 N/A N/A N/A Products cancelled 5/23/2012. 6. Freshwater fish rainbow trout-Acute 9/30/2005 N/A N/A N/A Products cancelled 5/23/2012. 7. Aquatic plant growth (conducted at maximum seasonal use rate) 9/30/2005 N/A N/A N/A Products cancelled 5/23/2012. Tebufenpyrad RD 8/26/2002 1. 90-day inhalation study no date specified This was registered under 3c5 and data was confirmatory. Data not submitted to date. Registrant notified 2/3/2014. Company intends to conduct study nd submit by 9/2014. 1. Analytical reference standard for tembotrione and its M5 metabolite to the EPA National Pesticide Standards Repository 3/28/2008 N/A Satisfied 7/23/2008 Confirmed receipt of standard by Ft. Meade Laboratory (National Pesticide Standards Repository) Tembotrione RD 9/28/2007 2. Revision of enforcement methods LC/MS/Ms Methods AE/03/01 for plant commodities and 00967 for livestock commodities to include a calculation for the conversion of residues of the metabolite(s) to parent equivalents for quantitation 9/28/2008 47552801,47552802 Satisified 9/29/2008 3. Life cycle study of estaurine/marine invertebrates 9/8/2009 47623501 In Review 12/15/2008 4. Chemical-specific dislodgeable foliar residue study 9/28/2009 47305501 waiver requested waiver granted 12/19/2007 waiver granted 10/10/2008 1. 28-day Inhalation Study 8/8/2005 N/A N/A N/A Voluntarily cancelled. 2. Developmental neurotoxicity study 8/8/2005 N/A N/A N/A Voluntarily cancelled. 3. Residue data on soybean aspirated grain fractions (qrain dust) 8/8/2005 N/A N/A N/A Voluntarily cancelled. Tepraloxydim RD 8/8/2001 4. Aerobic aquatic metabolism study 8/8/2005 N/A N/A N/A Voluntarily cancelled. 5. Leaching adsorption/desorption-mobility of aqed residues 8/8/2005 N/A N/A N/A Voluntarily cancelled. 6. Photolysis in water 8/8/2005 N/A N/A N/A Voluntarily cancelled. 7. Terrestrial field dissipation studies 8/8/2005 N/A N/A N/A Voluntarily cancelled. Tetraconazole RD 4/14/2005 1. Single side-by-side sugar beet field trial comparing two and six applications of Eminent 125SI at 0.10 lb ai/acre/application. The retreatment intervals for the plot receiving six applications should be 14 days and the RTI for the plot receiving two applications should be 21 days (the final application and harvest dates for each should be identical; preharvest interval (PHI) of 14 days; 4 samples from each plot should be collected 5/1/2007 47111401 Satisfied 4/23/2007 2. 28-day inhalation study based on the current use pattern 2/1/2007 46990301 Satisfied 11/21/2006 3. Study determining toxicity to benthic orqanisms (includinq chronomid) 1/1/2006 46614304 Satisfied 8/2/2005 4. Study determininq the toxicity to earthworms 12/1/2006 46614305,46614306 Satisfied 8/2/2005 5. New quideline adsorption/desorption study 11/1/2006 47023201 Satisfied 1/8/2007 1. Confirmatory procedure for the livestock tissue analytical enforcement method 3/26/2004 waiver requested waiver granted 1/14/2004 Waiver granted 12/16/04 2. Photodeqration in soil 9/26/2004 44927933 Satisfied 4/28/2004 Found to be acceptable 6/16/04 3. One year storaqe stability 9/26/2005 46462301 Satisfied 2/4/2005 Found to be acceptable 9/23/05 4. Corrosion characteristics 9/26/2005 46462301 Satisfied 2/4/2005 Found to be acceptable 9/23/05 Thiacloprid RD 9/26/2003 5. Bioaccumulation in fish 9/26/2005 44927602 waiver requested waiver granted 6/8/2004 MRID submitted supported waiver request which was qranted on 8/3/04 6/1/2015 32 of 35 ------- Chemical Division Reft Notice Date Conditional Data Requirement(s) MRID for Studv Review Status Date Data I Due Date - . .... 6. Limited field accumulation studies in rotational crops for wheat and soybeans 9/26/2007 46677901,46677902 N/A 10/28/2005 A waiver request was submitted along with data on wheat and soybeans. Data not reviewed since 12 month plant back interbal was retained. 7. Five batch analysis when commercial batches available/ 46677905 Satisfied 10/28/2005 1. Modification of Method AG-675 to add microwave extraction of liver or a new enforcement method for liver, additional radiovalidation data for beef liver 3/4/2002 45659202,45659203 Satisfied 4/23/2002 2. Storage stability data continued to cover the conditions and intervals that plant and animal commodity samples were stored (up to 30 months) 3/4/2002 45659204, 45659205 Satisfied 4/23/2002 Thiamethoxam RD 12/4/2000 3. Reanalysis of the cow liver samples from the feeding study using a microwave extraction step 3/4/2002 45659206 Satisfied 4/23/2002 4. Reanalysis of field rotational crop samples for metabolite CGA-265307 and description of storage conditions for future uses 3/4/2002 45659201 Satisfied 4/23/2002 5. Plant metabolism study on a leafy vegetable (Crop group 4 or 5) 3/4/2002 45093714 Satisfied 3/31/2000 6. Poultry metabolism study 3/4/2002 44703526,44715115 Satisfied 11/19/98, 12/10/98 7. Developmental neurotoxicity study 12/4/2002 46028201,46028202 Satisfied 7/3/2003 8. Repeated daphnia chronic study 12/4/2002 45500001 Satisfied 9/19/2001 1. Analytical reference standards: Thiencarbazone-methyl and its metabolites BYH 18636-MMT-glucoside, BYH 18636-MMT and isotopically labeled standards provided to the EPA National Pesticide Standards Repository 9/30/2009 sample(s) received Satisfied sample(s) received 2. Additional storage stability data (sample extraction and analysis dates for all samples) for the wheat crop field trial study 9/30/2010 47715301 49428301 Satisfied 3/27/2009 7/14/14 3. Immunotoxicity study 9/30/2010 48263001 Satisfied 10/15/2010 4. Terrestrial field dissipation guideline currently classified as supplemental-upgradable pending review of recently submitted additional soil storage stability data no date specified 47525801 Satisfied 9/2/2008 Thiencarbazone- methyl RD 9/30/2008 5. Additional data for the analytical method for the determination of residues of BYH18636 and its metabolites BYH18636-carboxylic acid, BYH18636-sulfonamide, BYH18636 sulfonamide' carboxylic acid, BYH18636-MMT, and BYH18636-triazolinone carboxamide in soil and sediment using LC/MS/MS 9/30/2010 47070114,47070043, 47070118,47070044 rebuttal submitted reguesing original methods and validations be accepted. In Review 10/4/2010 6. Independent laboratory validation of method GS-004-W06-01 for the determination of BYH 18636 and its metabolites BYH18636- carboxylic acid, BYH18636-sulfonamide, BYH18636-sulfonamide carboxylic acid, BYH 18636-MMT and BYH18636- dicarboxysulfonamide in water using LC-MS/MS 9/30/2010 rebuttal submitted In Review 10/4/2010 7. Storage stability study conducted for a minimum of one year ambient warehouse conditions must be repeated and submitted 9/30/2010 47069902 waiver reguested waiver granted 9/29/2010 6/1/2015 33 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) 9/30/2009 MRID for Studv 47070114; 47070043; 47070118; 47070044 Review Status Date Data Comments , > - r- 8. Copy of analytical methods and samples In Review 10/4/2010 Samples received in Ft. Meade Lab. Expiration date for technical is 6/29/2022; expiration dates for metabolite samples are 8/30/2027, 11/8/2014, 2/20/2017. 9. 5-batch analysis reflecting commercial scale production 9/30/2009 47918601 Satisfied 11/25/2009 Tolfenpyrad RD 7/28/2010 1. 90-day dermal toxicity study in rat, storage stability, corrosion characteristics 7/28/2011 482334021, 482334022 Satisfied 9/20/2010 2. for prod. Chem. Review, submit analytical method as described in MRIDs 47447704 and 47447705, and samples to EPA lab for validation 7/28/2011 48660301 Satisfied 9/20/2010 Topramezone (BAS 670H) RD 8/10/2005 1 .Aerobic aquatic metabolism 7/31/2008 47496702 In Review 8/1/2008 2. Anaerobic Aquatic Metabolism 7/31/2008 47496703 In Review 8/1/2008 3. Mobility in Soils 7/31/2008 45902425, 46242703 Satisfied 3/28/03, 4/6/04 4. Frozen Storage Stability 7/31/2008 47496704, 47496705, 47496708 In Review 8/1/2008 5. Avian Subacute Dietary 7/31/2008 47496708, 47496707 Satisfied 8/1/2008 6. Avian Reproduction 7/31/2008 47496708, 47496707 Satisfied 8/1/2008 7. Aquatic Invertebrate Life-cycle 7/31/2008 47496707 In Review 8/1/2008 8. Aquatic Plant Growth (Tier II) (Navicula) 7/31/2008 48600403 Satisfied 3/2/2012 9. Seedlinq Emerqence (Tier II) 7/31/2008 45902327 Satisfied 3/28/2003 10. Veqetative Viqor (Tier II) 7/31/2008 45902328 Satisfied 3/28/2003 11. Adequate storage stability data in the plant and livestock metabolism studies by 7/31/2008 7/31/2008 45902410 3/28/2003 12. 5 batch analysis Trifloxysulfuron RD 9/29/2003 1. Independently validated analytical chemistry methods to identify and quantify residues in water. These methods must be sufficiently sensitive to adequately determine NOAEC, EC05, and characterize residues in water resources 9/29/2008 47534701, 47534702 In Review 9/9/2008 2. Repeat of the Tier II aquatic vascular plant test on Lemma gibba with the technical in the acidic pH range 9/29/2008 47168201 Satisfied 7/2/2007 3. Repeat of the Tier II aquatic plant test on the blue-green algae Anabaena flos-algae with the technical 9/29/2008 47168202 Satisfied 7/2/2007 4. Product chemistry deficiencies 9/29/2008 47157600, 47157601 Satisfied 6/12/2007 1. Dermal sensitization study (870.2600)-submit positive control data conducted within 6 months of the study date for either MRID nos. 448020-34 or -35 or submit a new dermal sensitization study Oct-03 46817301 Satisfied 4/17/2006 2. 28-day (nose only) inhalation toxicity study in rats Oct-03 Waiver requested waiver granted 3/15/2005 3. Developmental neurotoxicity study Oct-04 waiver requested waiver granted 5/20/2005 4. Rat metabolism study Oct-04 46503401 Satisfied October, 2004 5. Mechanistic study (to be discussed and designed in collaboration with the registrant) no date specified n/a Reguirement withdrawn 6. Parital carcinogenicity study in the male rat at hiqher dose levels Dec-06 46552101 waiver requested waiver granted 5/23/2005 7. Additional storaqe and stability data Oct-04 47091801 Satisfied 3/29/2007 8. Avian Reproduction study in Bobwhite Quail Oct-04 48733902 Satisfied 2/1/2012 9. Acute Freshwater Fish Toxicity Study in Blueqill sunfish and rainbow trout Oct-03 46021001 Satisfied 6/30/2003 6/1/2015 34 of 35 ------- Chemical Division Rep. Notice Date Conditional Data Reauirement(s) MRID for Studv Review Status Date Data Comments , > - r- Received Triticonazole RD 9/30/2002 10. Freshwater Fish Early Life-Stage Toxicity Study Oct-04 46876702 Satisfied 7/3/2006 11. Freshwater Fish Chronic Life Cycle Toxicity Study Dec-04 46876703 Satisfied 7/3/2006 12. Acute Aquatic Invertebrate Freshwater Toxicity Study Oct-03 Satisfied 13. Daphnia maqna Life-Cycle Toxicity Study Dec-04 46876701 Satisfied 7/3/2006 14. Acute Estuarine/Marine Aquatic Animal Toxicity Studies Oct-03 Satisfied 15. Fish Early Life-Stage Estuarine/Marine Toxicity Study Oct-03 46876702 Satisfied October, 2003 16. Estuarine/Marine Invertebrate Life-Cycle Toxicity Study Oct-03 48842801 Satisfied Oct-03 17. Additional aerobic metabolism study Oct-03 47296303 (unacceptable) 49017701 in review In Review 12/5/2007, 12/2012 18. Aerobic aquatic metabolism study Dec-04 47296301 Satisfied 12/5/2007 19. Additional aqueous photolysis data Oct-03 47296302 Satisfied 12/5/2007 20. Corrected CSF and description of production process no date specified 46608801 Satisfied 7/27/2005 1. TLC scans for initial qrape extracts Dec-01 454614402 45461403 Satisified 7/25/2001 2. Substitution of derivatizing agent in the residue analytical method Dec-01 45437801;45437802 Satisfied 6/25/2001 3. Incorporate changes resulting from method review Dec-01 rebuttal to review sumbitted Satisfied 4. Protocol first then pulmonary sensitization study Dec-01 45568300 waiver requested No longer required 5. Storage stability data for the grape processing study Dec-01 45461402,45461403 Satisfied 7/25/2001 Zoxamide RD 4/11/2001 6. Product stewardship plan for monitoring and recording incidents related to inhalation and dermal sensitization. Biannual reports required, Dec-01 N/A Satisfied N/A Report received; no inicidents reported; no longer required. 7. Full scale production data including 5 batch analysis Dec-01 45568301;45568302 Satisfied 12/20/2001 8. Resistance monitoring data for potatoes Dec-01 45568303; 45568304; 45568305 Satisfied 12/20/2001 Submitted as part of harmonization effort with PMRA. BEAD determined data no lonqer needed. 9. Proximity information of endangered, threatened freshwater fish and estuaring/marine invertebrates to use sites Dec-01 waiver requested waiver granted 12/20/2001 Registrant is member of Endangered Species Task Force 6/1/2015 35 of 35 ------- |