Reregistration Eligibility Decision (RED) for MCPA (2-methyl-4-chlorophenoxyacetic acid) List A Case 0017 September 30, 2004 ------- $ A \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY IS3S? %i . WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant: This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of the available data and public comments received related to the preliminary risk assessment for the herbicide MCPA (2-methyl-4-chlorophenoxyacetic acid). The Agency has revised the human health and environmental effects risk assessments based on the comments received during the public comment period and additional data from the registrant. Based on the Agency's revised risk assessments for MCPA, EPA has identified risk mitigation measures that the Agency believes are necessary to address the human health and environmental risks associated with the current use of MCPA. EPA is now publishing its reregistration eligibility, risk management, and tolerance reassessment decisions for the current uses of MCPA, and its associated human health and environmental risks. The Agency's decision on the individual chemical MCPA can be found in the attached document entitled, "Reregistration Eligibility Decision for MCPA (2-methyl-4-chlorophenoxyacetic acid)" which was signed on September 30, 2004. A Notice of Availability for the Reregistration Eligibility Decision for MCPA is being published in the Federal Register. To obtain copies of the RED document, please contact the Pesticide Docket, Public Response and Program Resources Branch, Field and External Affairs Division (7506C), Office of Pesticide Programs (OPP), USEPA, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED and all supporting documents are available on the Internet. See www.epa.gov/pesticides/reregistration/status.htm. As part of the Agency's effort to involve the public in the implementation of the Food Quality Protection Act of 1996 (FQPA), EPA is undertaking a special effort to maintain open public dockets and to engage the public in the reregistration and tolerance reassessment processes. During the public comment period, comments on the risk assessments were submitted by the MCPA Task Force Three, representing the technical registrants and other registrants of end-use products. EPA also received comments from a grower group, attesting to the importance of MCPA as an herbicide, and from the California Regional Water Quality Control Board, commenting that EPA should establish water quality criteria for MCPA and conduct a cumulative assessment of the ecological effects of phenoxy herbicides. A close-out conference call with interested stakeholders and the United States Department of Agriculture was held on September 29, 2004, to discuss the risk management decisions and resulting label changes. Please note that the MCPA risk assessments and the attached RED concern only this particular pesticide and ------- its metabolites. The Food Quality Protection Act (FQPA) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to MCPA and any other substances, and MCPA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that MCPA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. This document contains generic and product-specific Data Call-In(s) (DCIs) that outline further data requirements for this chemical. Note that registrants of MCPA must respond to DCIs issued by the Agency within 90 days of receipt of this letter. This RED also contains labeling requirements for MCPA products. End-use product labels must be revised by the manufacturer to adopt the changes set forth in Section IV of this document. Instructions for registrants on submitting revised labeling and the time frame established to do so can be found in Section V of this document. Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the Agency will continue to have concerns about the risks posed by MCPA. Where the Agency has identified any unreasonable adverse effect to human health and the environment, the Agency may at any time initiate appropriate regulatory action to address this concern. At that time, any affected person(s) may challenge the Agency's action. There will be a 60-day public comment period for this document, commencing on the day the Notice of Availability publishes in the Federal Register. If you have questions on this document or the proposed label changes, please contact the Special Review and Reregistration Division representative, Kelly White at (703) 305-8401 or white.kelly@epa.gov. For questions about product reregistration and/or the Product DCI that accompanies this document, please contact Bonnie Adler at (703) 308-8523 or adler.bonnie@epa.gov. Debra Edwards, Ph.D. Director, Special Review and Reregistration Division Office of Pesticide Programs Attachment ------- Reregistration Eligibility Decision for MCPA List A Case 0017 Approved By: /s/ Debra Edwards, Ph.D. Director, Special Review and Reregistration Division September 30. 2004 Date ------- Table of Contents MCPA Reregistration Eligibility Decision Team i Glossary of Terms and Abbreviations ii Executive Summary iv I. Introduction 1 n. Chemical Overview 2 A. Regulatory History 2 B. Chemical Identification 3 C. Use Profile 4 D. Estimated Usage of Pesticide 5 HI. Summary of MCPA Risk Assessment 6 A. Human Health Risk Assessment 7 1. Dietary Risk from Food 7 a. Toxicity 7 b. FQPA Safety Factor 9 c. Population Adjusted Dose (PAD) 10 d. Exposure Assumptions 11 e. Food Risk Characterization 11 2. Dietary Risk from Drinking Water 11 a. Surface Water 12 b. Ground Water 13 c. Drinking Water Levels of Comparison (DWLOCs) 13 3. Residential Exposure and Risk 15 a. Toxicity 15 b. Residential Handler Risk 16 (1) Exposure Scenarios, Data, & Assumptions 16 (2) Residential Handler Risk Estimates and Risk Characterization/ d. Residential Postapplication Risk 18 (1) Exposure Scenarios, Data, & Assumptions 18 (2) Residential Postapplication Risk Estimates and Risk Characterization 20 3. Aggregate Risk 21 a. Acute Aggregate Risk Estimates and Risk Characterization 22 b. Short-term Aggregate Risk Estimates and Risk Characterization . 23 c. Chronic Aggregate Risk Estimates and Risk Characterization ------- 23 4. Cumulative Risk 23 5. Occupational Risk 24 a. Toxicity 24 b. Occupational Handler Exposure 25 c. Occupational Handler Risk 27 d. Postapplication Occupational Risk 29 (1) Data Sources, Assumptions, and Transfer Coefficients 30 (2) Occupational Postapplication Risk Estimates and Risk Characterization 32 e. Human Incident Data 32 B. Environmental Risk Assessment 33 1. Environmental Fate and Transport 33 2. Water Resource Assessment 33 a. Ground Water 33 b. Surface Water 34 3. Toxicity (Hazard) Assessment 35 a. Avian, Mammalian, and Non-target Insect Toxicity 35 Toxicity to Mammals 36 b. Toxicity to Aquatic Animals 37 c. Toxicity to Plants 38 4. Exposure and Risk Calculations 40 a. Levels of Concern 40 b. Exposure and Risk to Nontarget Terrestrial Animals 40 (1) Exposure to Birds and Mammals 40 (2) Avian Risk 41 (3) Risk to Mammals 42 (4) Risk to Insects 44 5. Exposure and Risk to Nontarget Aquatic Animals 44 a. Exposure and Risk to Nontarget Plants 44 (1) Risk to Terrestrial Plants 44 (2) Risk to Aquatic Plants 45 6. Ecological Incidents 46 7. Endangered Species 47 8. Risk Characterization 47 a. Terrestrial Animal Risk Characterization 47 b. Aquatic Organism Risk Characterization 48 c. Terrestrial and Aquatic Plant Risk Characterization 49 IV. Risk Management, Reregistration and Tolerance Reassessment 50 A. Determination of Reregistration Eligibility 50 B. Public Comments and Responses 51 ------- C. Regulatory Position 52 1. FQPA Assessment 52 a. "Risk Cup" Determination 52 b. Determination of Safety for U.S. Population 52 c. Determination of Safety for Infants and Children 52 d. Endocrine Disrupter Effects 55 e. Cumulative Risks 55 f. Tolerance Summary 55 (1) Codex/International Harmonization 58 2. Labels 59 3. Mitigation for Agricultural Uses 59 a. Use Cancellations 59 b. Application Rate Reductions 59 D. Regulatory Rationale 60 1. Human Health Risk Management 61 a. Dietary (Food) Risk Mitigation 61 b. Drinking Water Risk Mitigation 61 c. Residential Risk Mitigation 61 (1) Residential Handler Mitigation 61 (2) Residential Postapplication Mitigation 62 d. Aggregate Risk Mitigation 63 (1) Short-term Aggregate Risk 63 (2) Chronic Aggregate Risk 64 e. Occupational Risk Mitigation 64 (1) Handler Risk Mitigation 64 (2) Post-application Risk Mitigation 66 2. Environmental Risk Mitigation 67 3. Other Labeling Requirements 67 a. Endangered Species Statement 67 b. Spray Drift Management 68 V. What Registrants Need to Do 68 A. Manufacturing Use Products 70 1. Additional Data Requirements 70 2. Labeling for Manufacturing Use Products 71 B. End-Use Products 71 1. Additional Product-Specific Data Requirements 71 2. Labeling for End-Use Products 72 C. Labeling Changes Summary Table 72 ------- MCPA Reregistration Eligibility Decision Team Office of Pesticide Programs: Biological and Economic Analysis Assessment Jihad Alsadek Steve Jarboe Environmental Fate and Effects Risk Assessment Mark Corbin Christine Hartless Sidney Abel Health Effects Risk Assessment Byong-Han Chin Timothy Dole Felecia Fort Michael Metzger Whang Phang Risk Management Kelly White, Chemical Review Manager Thomas Brennan Demson Fuller Nathan Mottl ------- Glossary of Terms and Abbreviations Agricultural Data Call-In Acid Equivalent Active Ingredient Acute Population Adjusted Dose Anticipated Residue Bioconcentration Factor Code of Federal Regulations Chronic Population Adjusted Dose Confidential Statement of Formula USDA Continuing Surveys for Food Intake by Individuals Data Call-In Dietary Exposure Evaluation Model Dislodgeable Foliar Residue AGDCI ae ai aPAD AR BCF CFR cPAD CSF CSFII DCI DEEM DFR DWLOC Drinking Water Level of Comparison. EC Emulsifiable Concentrate Formulation EEC Estimated Environmental Concentration EPA Environmental Protection Agency EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery G Granular Formulation GENEEC Tier I Surface Water Computer Model GLN Guideline Number HAFT Highest Average Field Trial IR Index Reservoir LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm. LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg. LOG Level of Concern LOD Limit of Detection LOAEL Lowest Observed Adverse Effect Level MATC Maximum Acceptable Toxicant Concentration Hg/g Micrograms Per Gram Hg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted. MUP Manufacturing-Use Product NA Not Applicable NAWQA USGS National Water Quality Assessment NPDES National Pollutant Discharge Elimination System NR Not Required ------- NOAEL No Observed Adverse Effect Level OP Organophosphate OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted Dose PCA Percent Crop Area PDF USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data PHI Preharvest Interval ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model Qj* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model RAC Raw Agriculture Commodity RED Reregistration Eligibility Decision REI Restricted Entry Interval RiD Reference Dose RQ Risk Quotient SCI-GROW Tier I Ground Water Computer Model SAP Science Advisory Panel SF Safety Factor SLC Single Layer Clothing SLN Special Local Need (Registrations Under Section 24(c)) of FIFRA) TGAI Technical Grade Active Ingredient TRR Total Radioactive Residue USDA United States Department of Agriculture USGS United States Geological Survey UF Uncertainty Factor UV Ultraviolet WPS Worker Protection Standard 111 ------- Executive Summary EPA has completed its review of public comments on the preliminary risk assessments and is issuing its risk management decision for MCPA. The revised risk assessments are based on review of the required target data base supporting the use patterns of the currently registered products and additional information received from the MCPA Task Force Three. After considering the risks identified in the revised risk assessment and comments and mitigation suggestions from interested parties, EPA developed its risk management decision for uses of MCPA that pose risks of concern. The decision is discussed fully in this document. MCPA is an herbicide in the phenoxy or phenoxyacetic acid family that is used post-emergence for selective control of broadleaf weeds. MCPA is registered for use on alfalfa, barley, clover, flax, lespedeza, oats, pasture and rangeland grass, peas, rice, rye, sorghum, trefoil, triticale, and wheat, as well as grass grown for seed, to control a wide spectrum of broadleaf weeds. MCPA is also registered for use on turf, lawns, vines, rights-of-way, and forestry applications. Residential homeowners may use MCPA on lawns. Approximately 4.6 million pounds of MCPA active ingredient are applied annually to approximately 12 million acres (this figure includes both agricultural and non-agricultural use). Approximately 1.2 millions pounds of active ingredient are used annually on residential and commercial turf. Most of the agricultural use is allocated to spring wheat (56%), winter wheat (17%), barley (17%), and oats/rye (4%). The remaining usage is primarily on seed crops, pasture, hay, lots/farmsteads, dry beans/peas, and flax. Crops with a high percentage of the total U.S. planted acres treated include spring wheat (33%), barley (28%), flax (23%), summer fallow (9%), oats/rye (8%), and green beans/peas (4%). Most of the usage is in Michigan, California, Oregon, Idaho, North Carolina, Florida, Ohio, New York, Texas, Minnesota, North Dakota, and Washington. There are four active ingredients associated with MCPA: MCPA acid, MCPA sodium salt, MCPA dimethylamine salt (MCPA DMAS), and MCPA 2-ethylhexyl ester (MCPA 2-EHE). Formulation types registered include solids, soluble concentrate/solid, water dispersible granules (dry flowable), and wettable powder. MCPA is usually applied in combination with other phenoxy class chemicals, such as 2,4-D, 2,4- DB, MCPP-p, and MCPB. MCPA can be applied anytime, but is recommended for best efficacy in early spring and early fall. The Food Quality Protection Act (FQPA) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to MCPA and any other substances, and MCPA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that MCPA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements IV ------- released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. Dietary Risk Acute and chronic dietary exposures for food and drinking water do not exceed the Agency's level of concern; therefore, no mitigation is warranted at this time for any dietary exposure to MCPA. Residential Risk Acute residential risks posed by the use of MCPA are of concern to the Agency. However, EPA believes that those risks can be reduced to acceptable levels with implementation of the application rate reductions being required through this RED. In addition, the registrants have agreed to conduct a hand-press study as a condition of reregistration, which should allow the Agency to further characterize the potential for residential risks. Short-term residential risks are currently not of concern to the Agency. Aggregate Risk Short-term and chronic aggregate risk posed by the use of MCPA is not of concern to the Agency. No mitigation is required. Occupational Risk Occupational exposure to MCPA is of concern to the Agency. However, EPA believes that those risks can be reduced to acceptable levels with the implementation of the following mitigation measures: (1) requiring application rate reductions; and (2) cancelling use on rice and grain sorghum. Ecological Risk Ecological risks are of concern to the Agency. The mitigation measures of (1) reducing maximum application rates, (2) cancelling use on rice and grain sorghum, and (3) specifying a required spray droplet size of "medium to coarse" (i.e., prohibiting "fine" sprays) are expected to lessen, but not eliminate, the risk of MCPA to wildlife and plants. ------- Conclusions The Agency is issuing this Reregistration Eligibility Document (RED) for MCPA, as announced in a Notice of Availability published in the Federal Register. This RED document includes guidance and time frames for complying with any required label changes for products containing MCPA. With the addition of the label restrictions and amendments detailed in this document, the Agency has determined that all currently registered uses of MCPA are eligible for reregistration with the exception of rice. In addition, the registrant has agreed to cancel use on grain sorghum. The risk assessments for MCPA are based on the best scientific data currently available to the Agency and are adequate for regulatory decision making. There is a 60-day public comment period for this document. VI ------- I. Introduction The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate the reregistration of products with active ingredients registered prior to November 1, 1984. The amended Act calls for the development and submission of data to support the reregistration of an active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards arising from the currently registered uses of the pesticide; to determine the need for additional data on health and environmental effects; and to determine whether or not the pesticide meets the "no unreasonable adverse effects" criteria of FIFRA. On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This Act amends FIFRA to require tolerance reassessment during reregistration. It also requires that by 2006, EPA must review all tolerances in effect on the day before the date of the enactment of the FQPA, which was August 3, 1996. FQPA also amends the FFDCA to require a safety finding in tolerance reassessment based on factors including an assessment of cumulative effects of chemicals with a common mechanism of toxicity. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to MCPA and any other substances, and MCPA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that MCPA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. This document consists of six sections. Section I contains the regulatory framework for reregistration/tolerance reassessment. Section n provides a profile of the use and usage of the chemical. Section m gives an overview of the revised human health and environmental effects risk assessments resulting from public comments and other information. Section IV presents the Agency's reregistration eligibility and risk management decisions. Section V summarizes required label changes based on the risk mitigation measures outlined in Section IV. Section VT provides information on how to access related documents. Finally, the Appendices list Data Call-in (DCI) information. The revised risk assessments and related addenda are not included in this document, but are available on the Agency's web page www.epa.gov/pesticides. and in the Public Docket. ------- n. Chemical Overview A, Regulatory History MCPA was first registered in the United States in 1973. In the early 1980s, EPA conducted a thorough review of the scientific data base on MCPA and reassessed the Agency's earlier regulatory position. A Registration Standard for MCPA was issued in July 10, 1981, and an MCPA Guidance Document was issued in March 1982. In June 1988, EPA issued the MCPA Final Registration Standard and Tolerance Reassessment (FRSTR). This Reregistration Eligibility Decision (RED) reflects a reassessment of all data to date. The RED evaluates risks from all currently registered uses, including wheat, barley, oats, rye, residential turf, sod farms, golf courses, pasture-rangeland, and non-cropland rights-of-way. The document also presents EPA's evaluation of MCPA use on peas and flax, which is supported by the U.S. Department of Agriculture's (USDA's) Interregional Research Project #4 (TR-4). In an effort to promote transparency of the reregistation process and include the public in developing regulatory decisions, EPA has developed a public participation process that is used for pesticide tolerance reassessment and reregistation. This public participation process was developed in partnership with USDA, based on EPA's and USDA's experiences with the pilot public participation process used for the organophosphate pesticides, comments received from the Tolerance Reassessment Advisory Committee and the public during the public comment period on the proposed process, and EPA's experience with the interim process used in developing decisions for a number of non-organophosphate pesticides during the past few years. The public participation process encompasses full and modified versions that enable EPA to tailor the level of review to the level of refinement of the risk assessments, as well as to the amount of use, risk, public concern, and complexity associated with each pesticide. EPA followed a 4-phase, modified public participation process for MCPA. Consistent with this process, EPA initiated Phase 1 of the process by transmitting the human health and ecological risk assessments to the technical registrants for a 30-day error-correction review (Phase 1 opened on March 29, 2004). In Phase 2, EPA considered the errors that were identified by the registrants and made changes in the risk assessments as appropriate. To initiate Phase 3 of the process, EPA published a Federal Register notice announcing the availability of the revised risk assessments and supporting documents for a 60-day public review and comment period (Phase 3 opened on June 23, 2004). EPA received only 3 comments during the comment period, none of which were specific to the risk assessment or potential risk mitigation measures. A risk mitigation meeting was held with the MCPA Task Force Three and USDA on August 17, 2004. Following that meeting, the MCPA Task Force Three provided new information regarding use rates, acreage, application frequency, etc., which enabled EPA to significantly refine some of the risk assessments. A close- out conference call was conducted on September 29, 2004, to discuss the risk management decisions and resulting changes to the MCPA labels. ------- ------- B. Chemical Identification MCPA is an herbicide in the phenoxy or phenoxyacetic acid family. The basic manufacturers are Nufarm UK Limited, A.H. Marks & Co. Ltd., and Dow Agrosciences LLC. The following four forms of MCPA are registered in the United States: acid, dimethylamine salt (DMAS), sodium salt, and 2-ethylhexyl ester (2- EHE). The chemical names, structures, empirical formula, molecular weight, CAS registry numbers, and PC Codes of the registered MCPA forms are depicted in Figure A. Figure A: Chemical structures of MCPA Forms l^yc. CH3 0 I 1 - ^ 1 II CH CH3 0 3 CH3 0 ^V^^l CH2CH3 ll^O^^^ff^ ^^^CH2CH2CH2CH3 CH3 O MCPA acid Empirical Formula: C9H9C1O3 Molecular weight: 200.6 CAS Registry No. : 94-74-6 PC Code: 030501 MCPA dimethvlamine salt (DMAS) Empirical Formula: CUH16C1NO3 Molecular weight: 245.7 CAS Registry No.: 2039-46-5 PC Code: 030516 MCPA sodium salt (Na) Empirical Formula: C9H8ClNaO3 Molecular weight: 222.6 CAS Registry No.: 3653-48-3 PC Code: 030502 MCPA 2-ethvlhexvl ester (2-EHE) Empirical Formula: C17H25C1O3 Molecular weight: 312.5 CAS Registry No.: 29450-45-1 PC Code: 030564 MCPA acid is a white to light brown solid, flake, or microcrystalline powder with a melting point of 114-119 C, density of 1.18-1.21 g/ml at 20°C, octanol/water partition coefficient (log Kow) of 2.73, and vapor pressure of 7.7 x 10'6 mbar at 20°C. MCPA is practically insoluble in water (0.03 g/100 g at 20°C) and is soluble in a range of organic solvents including acetone (91.8 g/100 g), ethyl ether (50.2 g/100 g), chloroform (5.5 g/100 g), and benzene (3.3 g/100 g). ------- MCPA DMAS is a pale yellow or yellowish-white liquid with a boiling point of III °C, density of 1.181 at 20°C, and octanol/water partition coefficient (log Kow) of 1.415 at 25°C. MCPA DMAS rapidly dissociates in an aqueous medium to form the free phenoxy acid moiety and the dimethyl ammonium ion. MCPA 2-EHE is an amber to brown liquid with a boiling point of 260-265°C, bulk density of 8.9 Ib/gal (1.06 g/mL specific gravity), octanol/water partition coefficient (P0w) of 4.29 x 10"6, and vapor pressure of 1.77 x 10'5 mbar at 20°C. MCPA 2-EHE is slightly soluble in water (0.1%, w:w) and is miscible with most organic solvents and in mineral oils. Less chemical identification information is available concerning the MCPA sodium salt as compared to the other three MCPA formulations. MCPA sodium salt is water soluble and under acidic conditions it reverts to the acid form (see the MCPA acid chemical identification information, above). C. Use Profile The following is information on the currently registered uses including an overview of use sites and application methods. A detailed table of the uses of MCPA eligible for reregistration is contained in Appendix A. Type of Pesticide MCPA is an herbicide in the phenoxy or phenoxyacetic acid family that is used postemergence for selective control of broadleaf weeds. Phenoxy herbicides act by simulating the action of natural hormones and produce uncoordinated plant growth. MCPA disrupts both seedling emergence and vegetative vigor, and can be used to control both dicots and moncots. Use Sites MCPA is registered for use on alfalfa, barley, clover, flax, lespedeza, oats, grass, peas, rice, rye, sorghum, trefoil, triticale, and wheat, as well as grass grown for seed, to control a wide spectrum of broadleaf weeds. MCPA is also registered for use on residential lawns, sod farm turf, golf courses, rights-of-way, pasture, and rangeland. MCPA is usually applied in combination with other phenoxy class chemicals, including 2,4-D, 2,4-DB, MCPP, and MCPB. It can be applied anytime, but is recommended for best efficacy in early spring and early fall. The maximum application rate that was assessed in the RED is 4 Ib ai/A. The maximum application rate that is eligible for reregistration is 3 Ib ai/A. Target Pests MCPA is labeled for control of a wide variety of weeds. ------- Formulation Types Formulations include granulars, emulsifiable concentrates, soluble concentrate/liquids and wettable powders. Method and Rates of Application MCPA may be applied using aircraft, groundboom sprayers, broadcast spreaders, hand-held sprayers, and hose-end sprayers. Ground applications are made whenever possible due to lower cost and convenience, while aerial applications are made to rangeland areas where woody weeds are too tall for a tractor. Typically one application is made per growing season. The recommended application window for small grains is the four leaf stage up to the boot stage. Applications are not recommended in the boot to dough stage. Application rates range from 0.25 to 4.0 Ib acid equivalent per acre (ae/acre). The maximum application rate for wheat, the largest use of MCPA, is 1.5 Ib ae/acre. Timing of Application Typically one application is made per growing season, although two applications per year are permitted for certain crops or application sites. D. Estimated Usage of Pesticide Approximately 4.6 million pounds of MCPA active ingredient are applied annually to approximately 12 million acres (this figure includes both agricultural and non-agricultural use). Most of the acreage is treated with one pound a.i. or less per application and one pound a.i. or less per year. Approximately 1.2 million pounds of active ingredient are used annually on residential and commercial turf. Largest markets in terms of total pounds active ingredient include wheat, barley, turf, pasture, oats, rice, seed crops, flax, dry peas, green peas, and rye. Data presented by the MCPA Task Force at the 2001 SMART Meeting indicates that crops with a high percentage treated of total U.S. planted acres include flax (36%), barley (33%), wheat (27%), rice (22%), seed crops (21%), dry peas (16%), green peas (14%), and oats (14%). Most of the usage is in Michigan, California, Oregon, Idaho, North Carolina, Florida, Ohio, New York, Texas, Minnesota, and North Dakota. Table 1 below summarizes the best available estimates for the pesticide usage of MCPA. ------- Table 1: MCPA Crop Usage Summary Site Alfalfa Barley Beans/Peas, Green Flax Golf course turf Hay, Other [die Cropland Lawns and Turf Lots/Farmsteads/et Oats/Rye Pasture Rice Seed Crops Setaside Acres Sod Sorghum Summer Fallow Wheat, Spring Wheat, Winter Woodland Total Acres Grown (000) 23,701 7,326 709 175 - 33,881 7,275 - 24,232 6,184 75,719 2,992 1,516 20,521 152 11,140 28,567 21,311 44,907 62,089 Acres Treated (000) Wtd Avg 8 2050 30 40 31 25 15 0.5 8 500 47 110 140 27 2 4 76 7020 2080 2 12,337 Est Max 23 2,781 67 76 60 43 30 1.0 20 794 230 234 280 53 4 18 153 9,327 3,060 6 14,965 % of Crop Treated Wtd Avg 0.03% 28.0% 4.2% 22.9% - 0.1% 0.2% - 0.03% 8.1% 0.1% 3.7% 9.2% 0.1% 1.0% 0.03% 0.3% 32.9% 4.6% 0.003% Est Max 0.10% 38% 9% 43% - 0.13% 0.41% - 0.08% 13% 0.30% 8% 18% 0.26% 3% 0.16% 1% 44% 7% 0.01% LB AI Applied (000) Wtd Avg 3.1 760.0 8.6 13.6 28.0 16.6 13.3 - 6.1 190.0 18.4 73.3 59.9 12.8 1.6 3.1 16.6 2,550.0 770.0 0.4 4,606 Est Max 10.0 1,020.3 15.8 29.8 58.0 34.2 26.3 - 14.1 313.5 108.0 169.7 119.7 25.5 4.0 16.0 48.0 3,386.7 1,146.1 1.9 5,667 Average Application Rate Ib ai/ acre/yr 0.41 0.37 0.29 0.34 - 0.65 0.88 - 0.77 0.38 0.39 0.67 0.43 0.48 1.00 0.82 0.22 0.36 0.37 0.22 # appl/yr 1.22 1.06 1.00 1.01 - 1.19 1.00 - 1.24 1.03 1.00 1.04 1.00 1.02 1.00 1.00 1.05 1.10 1.00 1.08 Ibai/ A/appl 0.34 0.35 0.29 0.33 - 0.55 0.88 - 0.62 0.37 0.39 0.64 0.43 0.47 1.00 0.82 0.21 0.33 0.37 0.20 States of Most Usage (% of total Ib ai used on this site) WAWYMTIDPA80% ND MN WA ID 82% WAORWIUT81% NDSCMN81% CA WA OR MT NC ND 83% SD81% ND KS UT OR WA CA 66% ND SD MN PA WI ME 75% MN MO 80% CA AR 86% ORWA 86% ND WA MN OR 86% MN 100% KS 80% ND SD WA OR ID 84% ND MN SD 88% WA ID OR KS MT SD 79% ID 95% COLUMN HEADINGS Wtd. Avg. = Weighted average—the most recent years and more reliable data are weighted more heavily. Est. Max. = Estimated maximum, which is estimated from available data. Average application rates are calculated from the weighted averages. NOTES ON TABLE DATA Usage data primarily covers 1991 -2000. SOURCES: EPA, USDA , and National Center for Food and Agricultural Policy. III. Summary of MCPA Risk Assessment The following is a summary of EPA's human health and ecological risk findings and conclusions for the herbicide, MCPA, as presented fully in the following supporting risk assessment documents: MCPA Revised Human Health Risk Assessment for the Reregistration Eligibility Decision (RED) Document, dated June 4, 2004; MCPA Revised Human Health Risk Assessment for the Reregistration Eligibility Decision (RED) Document, dated September 14, 2004; and ------- Revised EFED Preliminary Risk Assessment for the 2-methyl-4-chlorophenoxyacetic acid (MCPA) Reregistration Eligibility Decision Document, dated April 14, 2004. The purpose of this RED document is to summarize the key features and findings of the risk assessment in order to help the reader better understand the risk management decisions reached by the Agency. While the risk assessments and related addenda are not included in this document, they are available in the public docket. A. Human Health Risk Assessment Risks from dietary exposure (food and drinking water), residential exposure, aggregate exposures, and occupational exposures have been evaluated for MCPA. MCPA has been classified as a "not likely" carcinogen; therefore, no carcinogenic analysis was conducted. 1. Dietary Risk from Food a. Toxicity The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database supports a reregistration eligibility determination for all currently supported uses. Further details on the toxicity of MCPA can be found in the June 4, 2004, Revised Human Health Risk Assessment. Tables 2-5, below, present a summary of the available acute toxicity data on MCPA acid, MPCA DMAS, MCPA 2-EHE, and MCPA sodium salt. The available data indicate that acute oral, dermal, inhalation, and primary dermal irritation toxicity of MCPA are generally of low acute toxicity (Category UJ to IV). In primary eye irritation studies, only MCPA 2-EHE was found to be of low toxicity (Category IV). MCPA, MCPA DMAS, and MCPA sodium salt are considered to be strong to severe eye irritants (toxicity category I). Dermal sensitization potential studies showed that only MCPA 2-EHE was a dermal sensitizer. NOTE: The technical acute toxicity values included in this document are for informational purposes only. The data supporting these values may or may not meet the current acceptance criteria. Table 2: MCPA Acid Acute Toxicity Study Type Acute Oral (Rat) Acute Dermal (Rabbit' Acute Inhalation (Rat) lye Irritation (Rabbit) Dermal Irritation (Rabbit) Dermal Sensitization (Guinea pig) MRIDNo. 00021972 250090 40053101 250090 250090 43062806 RESULTS LD50 = 765 mg/kg LD50 > 2000 mg/kg LC50 > 6.3 mg/L Corneal opacity No dermal effects Not a skin sensitizer Toxicity Category III III IV I IV N/A ------- ------- Table 3: MCPA 2-EHE Acute Toxicity Study Type Acute Oral (Rat) Acute Dermal (Rabbit' Acute Inhalation (Rat) lye Irritation (Rabbit) Dermal Irritation (Rabbit) Dermal Sensitization (Guinea pig) MRIDNo. 156458 156459 156460 156522 156456 40352001 RESULTS LD50 = 1793 mg/kg LD50 > 2000 mg/kg LC50> 1.9.mg/L No eye irritation No dermal effects Skin sensitizer Toxicity Category III III III IV IV N/A Table 4: MCPA Amine Acute Toxicity Study Type Acute Oral (Rat) Acute Dermal (Rabbit' Acute Inhalation (Rat) lye Irritation (Rabbit) Dermal Irritation (Rabbit) Dermal Sensitization (Guinea pig) MRIDNo. 256980 256980 42113103 256980 256980 40352101 RESULTS LD50 = 1876 mg/kg LD50 > 2000 mg/kg LC50>1.69mg/L Corneal opacity Slight dermal irritant Not a skin sensitizer Toxicity Category III III III I III N/A Table 5: MCPA Sodium Salt Acute Toxicity Study Type Acute Oral (Rat) Acute Dermal (Rabbit' Acute Inhalation (Rat) lye Irritation (Rabbit) Dermal Irritation (Rabbit) Dermal Sensitization (Guinea pig) MRIDNo. 256979 256979 260067 256979 256979 41613003 RESULTS LD50 = 3105 mg/kg LD50 > 2000 mg/kg LC50>1.6mg/L Corneal opacity moderate irritation Not a skin sensitizer Toxicity Category III III III I III N/A A brief overview of the studies used for the dietary risk assessment is outlined in Table 6 in this document. Additional details regarding the dietary risk assessment can be found in the Revised MCPA Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision, dated June 2, 2004. 10 ------- Table 6: Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary Risk Assessment of MCPA Assessment Acute Dietary (General sopulation) Acute Dietary (Females, 13 - 50 years old) Chronic Dietary Cancer Dose (NOAEL) (mg/kg/da y) 50 40 4.4 Endpoint Clinical signs of neurotoxicity Total litter resorptions Hepatotoxicity and nephrotoxicity Study Developmental toxicity study with MCPA DMAS in rats at a LOAEL of 150mg/kg/day (MRID 44954102) Developmental toxicity study with MCPA 2-EHE in rats at a LOAEL of 120mg/kg/day (MRID 44954101) Chronic toxicity and carcinogenicity study in rats with a LOAEL of 17.6 mg/kg/day (MRID 40634101) Uncertainty Factor1 l,000x l,000x l,000x FQPA Safety Factor Ix Ix Ix PAD (mg/kg/ day) 0.05 0.04 0.0044 Classification: Not likely to be carcinogenic to humans 'Uncertainty factor of 1,000 is the result of a lOx for interspecies variability, a lOx factor for intraspecies variability, and lOx to account for the lack of a developmental neurotoxicity study. b. FQPA Safety Factor The Food Quality Protection Act (FQPA) directs EPA, in setting pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children, taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology and exposure databases. The statute authorizes EPA to modify this tenfold FQPA safety factor with a different FQPA factor only if reliable data demonstrate that the resulting level of exposure would be safe for infants and children. FQPA Special Safety Factor The Agency reduced the default 10X FQPA Special Safety Factor for potential special sensitivity in infants and children to IX after evaluating the hazard and exposure data for MCPA. The toxicity database includes acceptable developmental and reproduction studies on MCPA, and there is no evidence except in the developmental toxicity study with MCPA 2-EFffi (quantitative or qualitative) of susceptibility following in utero exposure to rats. Also, there is a low level of concern and no residual uncertainties for the effects seen in the developmental toxicity study in rats after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment. Therefore, the 10X FQPA Special Safely Factor was reduced to IX. Database Uncertainty Factor EPA concluded that a developmental neurotoxicity study is necessary to further characterize the potential for pre-natal neurotoxicity due to the presence of clinical signs indicative of neurotoxicity in acute and subchronic studies. The MCPA toxicology database does not include a DNT study. Therefore, the 11 ------- Agency applied a 10X Database Uncertainty Factor for assessing risks from exposure scenarios expected for children or pregnant women. The Agency believes that with the application of the Database Uncertainty Factor, the regulatory endpoints are protective of children despite the need for a DNT study. Note that based on an analysis of DNT studies previously submitted, the Agency has revised the size of the Database Uncertainty Factors for all dietary and residential risk scenarios, other than for acute exposures (see Section IV.C.l.c). c. Population Adjusted Dose (PAD) The PAD is a term that characterizes the dietary risk of a chemical and reflects the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e., RfD/FQPA safety factor). In the case of MCPA, the FQPA safety factor is 1; therefore, the acute or chronic RfD is equal to the acute or chronic PAD. A risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency's risk concern. Acute PAD: The acute PAD is the dose an individual could be exposed to on any given day and no adverse health effects would be expected to occur. A rat developmental toxicity study with MCPA DMAS resulted in a NOAEL of 50 mg/kg/day for the general population based on clinical signs of neurotoxicity. A rat developmental toxicity study with MCPA 2-EHE resulted in a NOAEL of 40 mg/kg/day for females that are 13 to 50 years old, based on total litter resorptions. The uncertainty factors selected were lOx for intra-species uncertainty, lOx for inter-species uncertainty, and lOx to account for the lack of a developmental neurotoxicity study, for a total uncertainty factor (UF) of l,000x. General Population: Acute RfD = 50 mg/kg/day (NOAEL) + 1,000 (UF) = 0.05 mg/kg/day. Acute PAD = Acute RfD + FQPA Safety Factor (1) = 0.05 mg/kg/day. Females 13-50 years old: Acute RfD = 40 mg/kg/day (NOAEL) + 1,000 (UF) = 0.04 mg/kg/day. Acute PAD = Acute RfD + FQPA Safety Factor (1) = 0.04 mg/kg/day. Chronic PAD: A chronic reference dose for all populations was derived from a chronic toxicity and carcinogenicity study in rats. The study results yielded a NOAEL of 4.4 mg/kg/day based on hepatotoxicity and nephrotoxicity in rats at a LOAEL of 17.6 mg/kg/day. The uncertainty factors selected were lOx for intra-species uncertainty, lOx for inter-species uncertainty, and lOx to account for the lack of a developmental neurotoxicity study, for a total uncertainty factor (UF) of l,000x. 12 ------- Chronic RfD = 4.4 mg/kg/day (NOAEL) - 1,000 (UF) = 0.0044 mg/kg/day. Chronic PAD = Chronic RfD + FQPA Safety Factor (1) = 0.0044 mg/kg/day. d. Exposure Assumptions The acute dietary exposure to MCPA was estimated using DEEM-FCID™, Version 1.30, which incorporates food consumption data from USDA's Continuing Survey of Food Intake by Individuals (CSFII), 1994-1996, 1996. An unrefined Tier 1 assessment was conducted. For acute exposure, the level of residue present on the various commodities was assumed to be the current tolerance levels for MCPA acid as set forth at 40 CFR §180.339(a), and it was assumed that 100% of the various crops was treated with MCPA. Both DEEM™ and Lifeline™ were used to calculate the chronic dietary exposure estimates based on average consumption for the U.S. population and population subgroups including infants and children. For the chronic dietary analysis, the level of residue present on the various commodities was assumed to be the current tolerance levels for MCPA acid as set forth at 40 CFR §180.339(a), and percent crop treated information was incorporated. e. Food Risk Characterization Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD is not of concern. The acute dietary risk from MCPA residues on food is below the Agency's level of concern; that is, less than 100% of the acute PAD is utilized. For the most exposed subgroup, children (1-2 years), the percent acute PAD value is 36 at the 95th percentile of exposure. The chronic dietary risk from food alone is not of concern. For the most exposed subgroup, children (1 to 2 years old), the percent chronic PAD value is 87. 2. Dietary Risk from Drinking Water Drinking water exposure to pesticides can occur through ground water and surface water contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is carried out in tiers of increasing refinement, but is designed to provide high-end estimates of exposure. The Office of Pesticide Programs (OPP) adopted an environmental fate strategy for MCPA based on linking the dissociation of the salts of MCPA and the hydrolysis of the MCPA 2-EHE to its free acid, MCPA. In a dissociation study, MCPA-dimethylammonium salt completely dissociated to MCPA and dimethylammonium ion within 1.5 minutes of stirring in deionized water. Therefore, fate studies with MCPA will provide data regarding the behavior of MCPA-dimethylamine salt. 13 ------- Existing MCPA monitoring data evaluated in this exposure assessment were available from the United States Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program, the United States Environmental Protection Agency (USEPA) STOrage and RETrieval System for Water and Biological Monitoring Data (STORET), and recently released data from the USGS Pilot Reservoir Monitoring Study. The data were evaluated for magnitude and frequency of MCPA occurrence. Annual maximum concentrations and frequency of detection were determined from each data set. Time weighted annual mean (TWM) concentrations were determined for the NAWQA and STORET data. The frequency of detection of MCPA from the USGS Pilot Reservoir Monitoring Study was not sufficient to calculate TWM concentrations from these data. The highest annual maximum concentration of MCPA detected in surface water is 18.58 ug/1 from the NAWQA (station 4161820) study. The maximum TWM concentration of MCPA in surface water is 1.49 ug/1 from the NAWQA (station 4161820) study. The monitoring data were not targeted to MCPA use areas. Modeling was completed to augment the monitoring data. Surface water concentrations were modeled using the Tier n PRZM version 3.127 EXAMS version 2.98.04 model and the EFED graphical interface (PE4.pl dated January 9, 2003). Ground water concentrations were modeled using the Tier I SCIGROW version 2.2 model. Eight different crop scenarios were modeled to represent all registered uses and included wheat in North Dakota and Oregon, peas in Oregon, sorghum in Kansas, and rangeland/pastureland in California, Pennsylvania, and Minnesota. The OPP standard scenario for alfalfa was used as a surrogate for rangeland/pastureland in California, Pennsylvania, and Minnesota because its hydrologic and agronomic practices closely match those of pasture/rangeland and OPP does not have a currently approved pasture/rangeland scenario. The PRZM/EXAMS scenarios selected for modeling represent all available OPP scenarios for registered MCPA uses. a. Surface Water Based on modeling results, the estimated surface water-derived drinking water concentrations for the use of MCPA are: 47.3 ug/1 for the 1 in 10 year annual peak concentration (acute) 1.9 ug/1 for the 1 in 10 year annual mean concentration (non-cancer chronic) The PRZM/EXAMS model results were use in the human health risk assessment, rather than monitoring data, because the monitoring data available for MCPA is not specific to areas of use of MCPA. The recommended concentrations in surface water were derived from the Pennsylvania pasture scenario. The predicted surface water-derived drinking water concentrations will vary depending on regional climate, soil, environmental characteristics, and watershed characteristics. These model estimates are approximately double the peak (acute) concentration of 18.58 ug/1 detected in the monitoring data and roughly equivalent to the maximum TWM concentration of 1.49 ug/1. Rice 14 ------- Although the MCPA Task Force has indicated that the rice use of MCPA will not be supported, an end use product is currently registered for rice. For that reason, the Agency prepared an assessment to predict MCPA concentrations in surface source drinking water impacted from rice tail water releases. MCPA concentrations in surface source drinking water impacted from rice production were estimated using an interim screening level model developed by OPP. Model simulation of the maximum seasonal MCPA application rate of 1.25 pounds ae/acre results in a screening level peak and chronic drinking water concentration of 1222 ug/1. This value is expected to represent bounding concentration for peak and annual average drinking water concentrations for MCPA because the model represents an edge of paddy concentration rather than an actual concentration at a drinking water utility. Additionally, the model does not account for degradation, dilution, and dispersion of MCPA. Although, based on a Kd value or 0.6 ml/g, MCPA is expected to be highly mobile in tailwater from rice paddies, it is expected to degrade relatively rapidly in soil and be fairly persistent in aquatic environments. As expected, the estimated MCPA concentration from the interim model is higher than concentrations detected in the surface water monitoring data evaluated as part of this assessment. The highest concentration of MCPA detected in surface water was 18.58 ug/1 from the NAWQA data. The highest concentration of MCPA detected in surface water in several locations within and downstream of California counties for which MCPA was used on rice was 0.94 ug/1 (from NAWQA data). Rice is grown in areas of California, Arkansas, Mississipi, Louisiana, and Texas. It is unlikely that there will be concentrations of MCPA as high as the modeled estimate in surface water source drinking water due to use on rice. b. Ground Water The SCI-GROW model estimate of MCPA concentration in drinking water from shallow groundwater sources is 2.13 ug/1 using the pasture/rangeland application rate of 4 Ibs. ae/acre. MCPA was not detected in the NAWQA or STORET groundwater monitoring data evaluated for this assessment. The estimated concentration can be considered as both the acute and chronic value. Rice SCI-GROW modeling estimates the acute and chronic concentration of MCPA in shallow groundwater from use on rice at a rate of 1.25 Ibs ae/acre is 0.59 ug/1. c. Drinking Water Levels of Comparison (DWLOCs) Exposure to pesticides through drinking water can occur as a result of groundwater or surface water contamination. EPA considers both acute (one day) and chronic (multiple year) drinking water risks. To determine the maximum allowable contribution from water allowed in the diet, EPA first looks at how much of the overall risk is contributed by food and then determines a "drinking water level of comparison" (DWLOC). The DWLOC represents the maximum allowable contribution to the human diet that may be attributed to residues of a pesticide in drinking water after dietary exposure is subtracted from the aPAD or cPAD. Risks from drinking water are assessed by comparing the DWLOC to the estimated 15 ------- environmental concentrations (EECs) in surface water and ground water. Generally, the Agency has no risk concerns when the EECs are below the DWLOC. The results of the Agency's drinking water analysis are summarized in this document. Details of this analysis are found in the Revised Human Health Risk Assessment, dated June 4, 2004. Table 7, below, presents the calculations for the acute drinking water assessment, and Table 8 presents the calculations for the chronic drinking water assessment. Table 7: MCPA: Summary of Acute DWLOC Calculations Copulation Subgroup General U.S. Population "emales 13-50 yrs Children 1-2 yr All Infants aPAD (mg/kg/day) 0.05 0.04 0.05 0.05 Food Exposure1 (mg/kg/day) 0.0084 0.0045 0.018 0.011 Available Water Exposure2 (mg/kg/day) 0.042 0.036 0.032 0.039 DWLOC3 (ugfl) 1455 1066 322 392 1 Food Exposure = aPAD x % aPAD accounted for by food 2 Available water exposure = aPAD - food exposure 3 DWLOC = water exposure x body weight Liters of water x 10"3 where body weight = 70 kg for U.S. Population, 60 kg for females, 10 kg for infants and children Liters of water = 2L for Adults and 1L for infants and children Table 8: MCPA: Summary of Chronic DWLOC Calculations Population Subgroup General U.S. Population Females 13-50 Children l-6yr. All Infants cPAD (mg/kg/day) 0.0044 0.0044 0.0044 0.0044 Food Exposure1 (mg/kg/day) 0.0012 0.00086 0.0038 0.00099 Available Water Exposure2 (mg/kg/day) 0.0032 0.0035 0.00059 0.0034 DWLOC3 (ug/l) 111 106 5.88 34.08 2 Available water exposure = cPAD - food exposure 3 DWLOC = water exposure x body weight Liters of water x 10"3 where body weight = 70 kg for U.S. Population, 60 kg for females, 10 kg for infants and children Liters of water = 2L for Adults and 1L for infants and children Table 9, below, presents a comparison of the EECs with the DWLOCs. The EECs are below the DWLOC values, which indicates that the drinking water residue contribution to the acute and chronic dietary risk from MCPA is not of concern to the Agency. 16 ------- Table 9: MCPA: Acute and Chronic DWLOC Values Com Population Subgroup General U.S. Population "emales 13-50 yrs. Children 1-2 yrs. All Infants General U.S. Population "emales 13-50 Children 1-6 yr. All Infants Assessment Type acute Chronic DWLOC (ug/1) 1455 1066 322 392 111 106 5.88 34.08 pared to Modeled EECs EEC (Surface Water) (ug/1) 47.3 47.3 47.3 47.3 1.9 1.9 1.9 1.9 EEC (Ground Water) (ug/I) 2.13 2.13 2.13 2.13 2.13 2.13 2.13 2.13 3. Residential Exposure and Risk MCPA is registered for use by homeowners in the residential environment to kill weeds on lawns. It is also used by professional law care operators on residential lawns. Residents may be exposed to MCPA through mixing, loading, or applying the pesticide, or by entering a treated site after a residential or commercial applicator (pest control operator and law care operator) has applied MCPA. Residential risk is measured by a Margin of Exposure (MOE), which measures how close the residential exposure comes to the NOAEL from animal studies. Generally, MOEs that are greater than 100 do not exceed the Agency's level of concern (this incorporates the standard uncertainty factors of lOx for interspecies variability and lOx for intraspecies variability). However, for the MCPA residential exposure assessment, the level of concern is 1,000 because it also includes a 10X Database Uncertainty Factor to account for the lack of a developmental neurotoxicity study. Thus, scenarios that yield MOEs below 1,000 may indicate a risk concern. For more details about the residential risk assessment, see the MCPA Revised Occupational and Residential Exposure and Risk Assessment, dated June 11, 2004, which is available in the public docket. A summary of the inputs and results of this risk assessment are presented below. a. Toxicity The lexicological endpoints used for the residential risk assessment are provided in Table 10. 17 ------- Table 10: MCPA Toxicological Endpoints Used for Residential Risk Assessment exposure Scenario Dermal - Short and ntermediate Term nhalation - Short and ntermediate Term Incidental Oral - Short and ntermediate Term Dose or Factor Used in Risk Assessment Dermal NO AEL= 100 mg/kg/day NOAEL = 4.4 mg/kg/day1 NOAEL= 4.4 mg/kg/day2 Study 21 -day dermal toxicity study in rats Chronic toxicity and carcinogenicity study in rats Subchronic neurotoxicity and chronic toxicity studies Toxicological Effects LOAEL= 1000 mg/kg/day based on nephrotoxicity and decrease in body weight gain. LOAEL = 17.6 mg/kg/day based on hepatotoxicity and nephrotoxicity. Neurotoxicity, renal, and testicular toxicities 2 The Agency selected the dose of 4.4 mg/kg/day for short- and intermediate-term incidental oral exposure risk assessments based on the similarity of toxicity seen in the subchronic neurotoxicity studies in rats with the acid, DMAS, and 2-EHE forms, as well as the toxicity seen following chronic exposure in rats with the acid. b. Residential Handler Risk (1) Exposure Scenarios, Data, & Assumptions Potential residential exposures can occur as a result of residential application to lawns. The residential products are typically formulated as dry weed or feed products or as liquids in concentrates or ready to use sprays. Many of these formulations include other herbicides such as 2,4-D, MCPP-p, and dicamba. Both spot and broadcast treatments are included on the labels. The following residential scenarios were evaluated: (1) Hand application of granules; (2) Belly grinder application; (3) Loading/Applying granules with a broadcast spreader; (4) Mixing/Loading/Applying with a hose-end sprayer (mix-your-own); (5) Mixing/Loading/Applying with a hose-end sprayer (ready-to-use); (6) Mixing/Loading/Applying with a hand-held pump sprayer; and (7) Mixing/Loading/Applying with a ready-to-use sprayer. The duration of exposure is expected to be short term for broadcast treatments because the label allows only two broadcast treatments per year. Exposures are also expected to be short term in duration for spot treatments because the labels recommend repeat applications in two to three weeks for hard-to-kill weeds. 18 ------- No chemical-specific data were submitted for residential handler risk assessment, so values from the Pesticide Handler Exposure Database (PHED) and the Outdoor Residential Exposure Task Force (ORETF) were used. Exposure data for scenarios #1 and 2 were taken from PHED, and exposure data for scenarios #3, 4, and 5 were taken from the residential portion of the ORETF Handler Study (MRID 44972201). Exposure data for scenarios #6 and 7 were taken from MRID 44459801, another study owned by the ORETF. A more complete discussion of the ORETF studies from which the exposure information was derived is provided in the Occupational and Residential Exposure and Risk Assessment (revised version, dated June 11, 2004). For all residential scenarios, the exposure estimates assume that individuals wear short pants, short sleeves and no gloves. It was assumed that broadcast spreaders and hose-end sprayers would be used for broadcast treatments and the other application methods would be used for spot treatments only. It was also assumed that an area of 0.5 acres would be treated during broadcast applications, and that an area of 0.023 acres (1,000 square feet) would be treated per application during spot treatments. Further, it was assumed that the application rate is 2.0 Ib ae/acre. (2) Residential Handler Risk Estimates and Risk Characterization A summary of the short-term risk estimates for residential handlers is presented in Table 11. As noted previously, risk estimates are expressed in terms of an MOE. Residential application of MCPA products to lawns resulted in risk estimates that are not a risk concern to the Agency (i.e., total MOE > 1,000) for all scenarios except mixing/loading/applying with a hose-end sprayer (mix-your-own formulation). The mix-your-own hose-end sprayer scenario had an MOE of 620, and therefore exceeded the Agency's level of concern. Note that based on an analysis of DNT studies previously submitted, the Agency has revised the Database Uncertainty Factors for all dietary and residential risk scenarios, other than for acute exposures (see Section IV.C. l.c). Using the revised uncertainty factors, in addition to data from a new dermal absorption study and lowered application rates, short-term risks to residential handlers are not of concern (see Section IV.D.l.c.l). 19 ------- Table 11: MCPA Short-Term MOEs for Homeowner A Equipment Type (1) Applying granules by hand or ihaker can (2) Loading/Applying granules with a belly grinder |3) Loading/Applying granules with a broadcast spreader (4) Mixing/Loading/Applying iquids with a hose-end sprayer Imix-your-own) (5) Mixing/Loading/Applying iquids with a hose-end sprayer Iready-to-use) 6) Mixing/Loading/Applying iquids with hand-held pump sprayer (T) Mixing/Loading/Applying iquids with ready-to-use sprayer Application Rate (Ib ae/acre) 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Dermal MOE (a) 1300 1400 10,000 640 2700 4000 2800 pplication to Lawns Inhalation MOE (b) 14,000 110,000 3,400,000 19,000 28000 1,500,000 190,000 Combined MOE (c) (MOE Level of Concern = 1000) 1200 1400 10000 620 2500 4000 2800 (a) Dermal MOE = NOAEL (100 mg/kg/day) / Daily Dermal Dose mg/kg/day). The NOAEL is from a dermal study. Therefore, no adjustment is made for dermal absorption. (b) Inhalation MOE = NOAEL (4.4 mg/kg/day) / Daily Inhalation Dose (mg/kg/day). An oral NOAEL was used to calculate the inhalation MOE. Inhalation absorption was assumed to equivalent to oral absorption. (c) Total MOE = 1 / (1 /MOE dermal + 1 /MOE inhalation). d. Residential Postapplication Risk (1) Exposure Scenarios, Data, & Assumptions Exposure Scenarios Potential residential postapplication exposures to adults and children may occur as a result of residential application or professional lawn care operator application of MCPA products. Specifically, adult and child exposures were evaluated as a result of ornamental, golf course, and recreational turf and home lawn uses. Guidance from the Agency's Residential SOPs was used to address the exposures of children contacting recently treated turf. The SOPs use a high contact activity to represent the exposures of an actively playing child. The following residential postapplication scenarios were evaluated: (1) Acute and short-term exposures of toddlers playing on treated turf; 20 ------- (2) (3) Acute and short-term exposures of adults performing yardwork on treated turf; Acute and short-term exposures of adults playing golf on treated turf. Data Sources There were three chemical-specific turf transferable residue (TTR) studies that were submitted by the Broadleaf Turf Herbicide TTR Task Force. These studies measured the dissipation of several phenoxy herbicides, including MCPA, using the ORETF roller technique (which is also called the modified California Roller). The studies have been reviewed by The Agency and were found to meet all of the series 875 guidelines for postapplication exposure monitoring. The TTR studies are discussed in detail in Appendix E of theMCPA Revised Occupational and Residential Exposure and Risk Assessment, dated June 11, 2004. Table 12, below, provides a summary of the TTR data used for the MCPA post application exposure assessment. Table 12: Summary of Turf Transferable Residue Data Used for MCPA Post Application Exposure Assessment Study MRID Location Precipitation Application Rate MCPA Form Applied Maximum TTR % Maximum TTR Day 0 Average TTR % Average TTR Semi-log Slope Factor Days to LOQ 44655702 North Carolina No Rain 1.55 DMAS 0.53 3.1 -Note 1 0.231 1.3 -0.68 7 44655702 North Carolina No Rain 1.55 2-EHE 0.318 1.8 0.31 1.8 -Note 2 -0.73 -Note 2 7 45033101 California No Rain 1.47 DMAS Mix 0.26 1.6 0.20 1.2 -Note 2 -0.44 - Note 2 greater than 7 Note 1 - This value was used to derive the TTR for Iday acute exposures. Note 2 - These values were used to derived the TTR for seven day average short term exposures. Assumptions It was assumed that the maximum label application rate of 2.0 Ibs ae/acre was used. Additionally, the following general assumptions, from the Standard Operating Procedures (SOPs) of December 18, 1997, and ExpoSAC Policy #12, "Recommended Revisions to the Standard Operating Procedures for Residential Exposure Assessments of February 22, 2001" were used: 21 ------- (1) The TTR values were used for calculating dermal exposures on turf because they were greater than 1.0% of the application rate. The TTR values were adjusted by a factor of 1.33 to account for the label application rate of 2.0 Ib ae/acre vs the TTR study application rate of 1.5 Ib ae/acre. (2) An assumed initial TTR value of 5.0% of the application rate is used for assessing hand to mouth exposures. (3) An assumed initial TTR value of 20% of the application is used for assessing object to mouth exposures. (4) Soil residues are contained in the top centimeter and soil density is 0.67 mL/gram. (5) Three-year-old toddlers are assumed to weigh 15 kg. (6) Hand-to-mouth exposures are based on a frequency of 20 events/hour and a surface area per event of 20 cm2 representing the palmar surfaces of three fingers. (7) Saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately /^ of the residues on the hand are removed. (8) Adults are assessed using a transfer coefficient of 14,500 cm2/hour. (9) Toddlers are assessed using a transfer coefficient of 5,200 cm2/hour. (10) Golfers are assessed using a transfer coefficient of 500 cm2/hour. (11) An exposure duration of 2 hours per day is assumed for toddlers playing on turf or adults performing heavy yardwork. (12) An exposure duration of 4 hours is assumed for playing golf. (2) Residential Postapplication Risk Estimates and Risk Characterization Table 13, below, presents the residential turf MOEs for toddlers. The total MOE includes the dermal, hand-to-mouth, object-to-mouth, and soil ingestion pathways. MOEs that are below 1,000 exceed EPA's level of concern for residents, children, or other non-occupationally exposed individuals. As shown in bold, the short-term MOE for toddlers was below 1,000, and therefore was of concern. The total short term MOE using the maximum TTR value was 280. Dermal exposure was the risk driver that caused the total MOE to be low. Note that based on an analysis of DNT studies previously submitted, the Agency has revised the Database Uncertainty Factors for all dietary and residential risk scenarios, other than for acute exposures (see Section IV.C. l.c). Using the revised uncertainty factors, in addition to data from a new dermal absorption study and lowered application rates, short-term postapplication residential risks are not of concern (see Section IV.D.l.c.2). Also, based on the new dermal absorption study and lowered application rates, acute risk estimates are now significantly lower (total MOE = 940; see Section IV.D.l.c), which only slightly exceeds the Agency's level of concern. Because the MOE for combined toddler acute exposures may be of concern to the Agency, the MCPA Task Force has committed to undertake a study to determine the dermal 22 ------- transfer efficiency of MCPA residues from turf to dry and wetted palms. This hand-press study is intended to confirm that the transfer coefficient used in the toddler exposure assessment is conservative and overestimates risk from mouthing behaviors. The Agency believes that the chemical-specific data in this study will verify that the residue dislodgeable from wet hands is, to some degree, less than the 5% default used in the assessment. This study must be submitted within the 9-month time period allotted to submit revised labels for MCPA. Table 13: Toddler MOEs for Exposure to Turf Treated with MCPA Residue Time Segment Application Rate (Ibs ae/acre) ITR (ug/cm ) Dermal MOE Hand-to Mouth MOE Object to Mouth MOE Soil Ingestion MOE Total MOE Acute Toddler Risks Using the Maximum TTR (North Carolina Trial 1 using MCPA DMAS) MAX TTR 2.0 J0.685A J350 1700 J6700 Short Term Toddlers Risks Using California TTR Data (MCPA DMAS Mix, No Rain) AvgofDAT 0 to DAT 6 2.0 0.13B 1100 380 1500 >100000 J280 >100000 380 Short Term Toddler Risks Using North Carolina TTR Data from Trial 1 (MCPA 2-EHE, No Rain) AvgofDAT 0 to DAT 6 2.0 0.108C 1300 540 2100 >100000 470 A. This value was derived from the maximum TTR of 3.1 percent (0.531 ug/cm at 1.55 Ib ae/acre) which occurred on DAT 1. 3. This value was derived from the initial TTR of 1.6 percent (0.263 ug/cm at 1.47 Ib ae/acre) and the regression slope factor of - 0.44X. C. This value was derived from the initial TTR of 1.8 percent (0.306 ug/cm at 1.54 Ib ae/acre) and the regression slope factor of - 0.73X. The MOEs for adult exposures are summarized in Table 14. The acute MOEs were calculated using the maximum TTR. The short-term MOEs were calculated using the seven-day average TTR from the California site. As shown in bold, the MOEs for acute exposure during heavy yardwork did not exceed 1000, and therefore were of concern to the Agency. Note that based on an analysis of DNT studies previously submitted, the Agency has revised the Database Uncertainty Factors for all dietary and residential risk scenarios, other than for acute exposures (see Section IV.C. l.c). Using the revised uncertainty factors, in addition to data from a new dermal absorption study and lowered application rates, short-term postapplication residential risks are not of concern (see Section IV.D.l.c.2). Table 14: Adult Acute and Short-term MOEs for Exposure to Turf Treated with MCPA Exposure Scenario Heavy Yardwork Playing Golf Application Rate (Ibs ae/acre) 2.0 2.0 TTR (ug/cm2) 0.685A 0.13B Females 13 to 50 Acute Dermal MOE 400 5800 All Other Adults Acute Dermal MOE 590 8500 All Adults Short Term Dermal MOE 1900 27000 23 ------- Exposure Scenario Application Rate (Ibs ae/acre) TTR (ug/cm2) Females 13 to 50 Acute Dermal MOE All Other Adults Acute Dermal MOE All Adults Short Term Dermal MOE A. This value was derived from the maximum TTR of 3.1 percent (0.531 ug/cm at 1.55 Ib ae/acre) which occurred on DAT 1. B. This value was derived from the initial TTR of 1.6 percent (0.263 ug/cm at 1.47 Ib ae/acre) and the regression slope factor of - 0.44X. 3. Aggregate Risk The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information." Aggregate exposure will typically include exposures from food, drinking water, residential uses of a pesticide, and other non-occupational sources of exposure. The Agency has developed several guidance documents describing the mathematical approaches used in calculating aggregate risks, the theoretical basis for these calculations, and the interpretation of the Food Quality Protection Act that requires the Agency to complete these kinds of calculations.l The underlying approach, regardless of the calculation type, is the same. The overall, allowable risks associated with an individual chemical is first determined by its hazard database and its associated uncertainty factors or negligible risks if the concern is cancer (i.e., an exposure limit is defined). Once limits have been defined, contributions from different sources are then added to obtain aggregate exposures (dietary [food only] and residential) which are compared to the exposure limit to see if it has been exceeded which would indicate a risk concern. If the aggregate exposure limit has not been exceeded, the unallocated portion under it, which is attributed to drinking water by convention as the DWLOC (Drinking Water Level of Concern) is then compared to environmental water concentration (EEC or Estimated Environmental Concentration) to see if the EEC exceeds the DWLOC, which would also indicate a risk concern. The Agency would not have a risk concern if DWLOCs were calculated and EECs were less than the DWLOCs. MCPA is a food use chemical. Drinking Water Levels of Comparison (DWLOCs) have been calculated, and there are residential (non-occupational) uses of MCPA. Therefore, the considerations for aggregate exposure to MCPA are those from food, drinking water, and residential exposure. For MCPA, aggregate risk assessments were conducted for acute (one day) and short-term (one to thirty days). Intermediate and chronic aggregate risks were not assessed because there are no expected intermediate and chronic residential exposures. 1 There are several aggregate risk guidance documents that address both deterministic and probabilistic risk assessment approaches. The major science policy papers are available at www.EPA.Gov/pesticides. The two key documents used for this assessment are 1) Updated Interim Guidance For Incorporating Drinking Water Exposure Into Aggregate Risk Assessments (Stasikowski, 8/1/99) and 2) HED RARC Format and Risk Characterization Guidance (12/22/00). 24 ------- a. Acute Aggregate Risk Estimates and Risk Characterization The acute residential turf exposures were not aggregated with the acute dietary exposures because it is extremely unlikely that acute turf exposures would occur concurrently with the acute dietary exposures. The risks of acute turf exposure were based upon high-end exposures from four individual pathways which include dermal exposure, hand-to-mouth exposure, object-to-mouth exposure, and soil ingestion, while the risks of acute dietary exposure were based upon high-end estimates of food residues and consumption patterns. Currently available distributional assessments lend support to the low likelihood of experiencing concurrent high-end exposures from all of these sources, and if necessary, chemical-specific higher-tier distributional assessments can be run if there is reason to believe that the assumptions made in the individual acute assessments will underestimate risks. 25 ------- b. Short-term Aggregate Risk Estimates and Risk Characterization An aggregate exposure assessment that quantifies short-term risks from food, water, and residential sources was not conducted because the Agency had concern regarding short-term risks from residential exposure alone. Note, however, that based on an analysis of DNT studies previously submitted, the Agency has revised the Database Uncertainty Factors for all dietary and residential risk scenarios, other than for acute exposures (see Section IV.C.l.c). Using the revised uncertainty factors, in addition to data from a new dermal absorption study and lowered application rates, the Agency determined that short-term residential risks are not of concern (see Section IV.D. 1 .c). See Section IV.C. 1 .d. 1 for a calculation of the short-term aggregate risks from food, water, and residential sources, which are not of concern to the Agency. c. Chronic Aggregate Risk Estimates and Risk Characterization No chronic residential scenarios have been identified for MCPA. Therefore, chronic DWLOCs for MCPA were calculated based on tolerance level residues in food alone. These values are presented in Table 15. Comparison of the chronic DWLOCs with the environmental concentrations of MCPA estimated using PRZM-EXAMS and SCI-GROW modeling indicates that chronic aggregate risks are not of concern. The DWLOCs are less than the surface water EEC of 1.9 ppb and the ground water EEC of 2.13 ug/1. Consequently, there is no chronic aggregate concern for drinking water from surface or groundwater sources. Table 15: MCPA Summary of Chronic DWLOC Calculations Population Subgroup U.S. Population Females 13-50 yrs Children 1-6 yr All Infants cPAD (mg/kg/day) 0.0044 0.0044 0.0044 0.0044 Food Exposure (mg/kg/day) 0.001235 0.000859 0.003812 0.000992 Available Water Exposure (mg/kg/day) 0.003165 0.003541 0.000588 0.003408 DWLOC (ug/1) 110 110 5.9 34 4. Cumulative Risk Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to MCPA and any other substances, and MCPA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that MCPA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at htto://www.eoa.gov/oesticides/cumulative/. 26 ------- 5. Occupational Risk Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide, or re-entering treated sites. Occupational handlers of MCPA include: workers in agricultural environments, turf farms, golf courses, and lawn care professionals. Risk for these potentially exposed populations is measured by a Margin of Exposure (MOE) which determines how close the occupational exposure comes to a No Observed Adverse Effect Level (NOAEL). In the case of MCPA, MOEs greater than 100 do not exceed the Agency's level of concern. This MOE level of concern of 100 is derived from the standard safety factors of lOx for intraspecies variability and lOx for interspecies variability. The additional FQPA 10X Database Uncertainty Factor for protection of infants and children that was used for assessing residential risk does not apply to occupational exposures. a. Toxicity The acute toxicity profile for MCPA is listed previously in Tables 2-5. Table 16, below, provides the toxicity endpoints used in the occupational risk assessment for MCPA. An uncertainty factor of 100X, incorporating factors of 10X for intraspecies variability and 10X for interspecies variability, was used for assessing occupational risk. The 10X FQPA Database Uncertainty Factor that was used for the residential risk assessment does not apply to the occupational risk assessment. Table 16: Toxicity Endpoints for MCPA Occupational Risk Assessment Exposure Scenario Dermal (Short/Intermediate Term) nhalation Short, Intermediate and long-Term Cancer Dermal Absorption 7actor Jncertainty Factor or Occupational exposures Dose or Factor Used in Risk Assessment Dermal NOAEL = 100 NOAEL = 4.4 mg/kg/dayA Study and Toxicological Effects 21 -day dermal toxicity study in rabbits LOAEL= 1 000 mg/kg/day based on nephrotoxicity and decrease in body weight gain. Chronic toxicity and carcinogenicity study in rats ^OAEL = 17.6 mg/kg/day based on lepatotoxicity and nephrotoxicity. Classification: Not likely to be carcinogenic to humans 30 percent of the oral dose 100 Dermal absorption study in rats with MCPA DMAS and MCPA 2-EHE. Includes standard factors of 10X and 10X for intraspecies variability and interspecies extrapolation. A Inhalation absorption is assumed to be equivalent to oral absorption (100 percent default value). 27 ------- b. Occupational Handler Exposure Formulation Types Currently, there are approximately 160 active products of MCPA formulated from 4 different forms. The acid, DMAS, 2-EHE forms of MCPA have the most products. Most of the products are formulated as liquids or granules, although two MCPA acid products are formulated as water soluble powders. These two products are used on turf. Application Rates, Timing, and Frequency Typically one application is made per growing season. The label recommended application window for small grains is the four leaf stage up to the boot stage. Applications are not recommended in the boot to dough stage. The label required spray volumes for ground applications range from 20 gallons for most crops to 100 gallons per acre for vine and brush control. MCPA can be applied over the top to the labeled crops. The maximum application rates range from 0.375 to 4.0 Ib ae/acre. One application is made to most crops. Application Methods The MCPA labels allow ground and aerial application, however, they do not allow chemigation. Ground applications are made whenever possible due to cost and convenience, while aerial applications are made to rangeland areas where woody weeds are too tall for a tractor (MCPA Smart Meeting, 2001). According to the USDA Crop Profile for Hard Red Spring and Durum Wheats in North Dakota, 93 percent of herbicide applications are made by ground equipment. A listing of application methods and amounts of acreage treated per 8 hour day is included in Table 17. Table 17: MCPA Application Methods Application Method Large Groundboom Average Groundboom Golf Course Groundboom Fixed Wing Aircraft Right of Way (ROW) Sprayer lurfgun Backpack Sprayer - Mix/Load/Apply Tractor Drawn Broadcast Spreader Push Type Broadcast Spreader Typical Crops Treated Small Grains, Flax, Peas Pasture Golf Course Turf Small Grains, Flax, Peas, Rice, Rangeland Weed Control - 20 gallons per acre Turf Spot Treatment Turf Turf Treated Area3 200 80 40 1200 50b 5 4C 40 5 28 ------- Application Method I Typical Crops Treated | Treated Area" a. Based upon HED Exposac_SOP #9 "Standard Values for Daily Acres Treated in Agriculture", Revised July 5, 2000 b. Based upon 1000 gallons of spray applied per day from SOP #9 divided by an estimated spray volume of 20 GPA. c. Based upon 40 gallons of spray applied per day from SOP #9 divided by an estimated spray volume of 10 GPA. Exposure Scenarios Short- and intermediate-term occupational risks have been assessed. Chronic occupational risks were not assessed because they are generally not expected for agricultural uses, and because chronic occupational exposure is particularly unlikely for MCPA. It is typically applied only once per season, and there is a limited window of time in the growing season during which use of the product is appropriate. There is potential occupational handler exposure during mixing, loading, and applying products containing MCPA to agricultural crops and turf. Based on the application methods show in Table 17, the following exposure scenarios were assessed. (1) Mixing/Loading Wettable Powder (2) Mixing/Loading Liquid Formulations (3) Loading Granules (4) Aerial Application (5) Groundboom Application (6) Turfgun Application (7) Right-of-Way Application (8) Broadcast Spreader Application (9) Mixing/Loading/Applying Liquids with a Backpack Sprayer (10) Mixing/Loading/Applying Wettable Powder with a Turfgun (11) Mixing/Loading/Applying Liquids with a Turfgun (12) Loading/Applying Granules with a Push Cyclone (13) Flag Aerial Application For agricultural handlers, the estimated exposures initially are assessed assuming handlers are using baseline attire (i.e., long-sleeve shirt, long pants, shoes, and socks). If risk estimates exceed the level of concern for a given scenario with baseline attire, then exposures are assessed with the addition of personal protective equipment (PPE) (i.e., chemical-resistant gloves, double-layer body protection, and/or a respirator) as required. In general, the Agency uses the least PPE necessary to achieve risk estimates that do not exceed the level of concern. If the risk estimates exceed the Agency's level of concern (i.e., if MOE < 100) for a given scenario even with the addition of PPE, then the risks are assessed with the use of engineering controls (i.e., closed system mixing/loading and enclosed cabs or cockpits for applying and flagging). Handler Exposure Assumptions 29 ------- The following assumptions and factors were used in order to complete the exposure and risk assessments for occupational handlers/applicators. The average work day was 8 hours. • The daily acreages treated were taken from EPA Science Advisory Council for Exposure Standard Operating Procedure #9 "Standard Values for Daily Acres Treated in Agriculture," Revised July 5, 2000. These values are provided in the ORE Chapter. The application rates were generally the maximum rates as listed on one or more labels. The lower Task Force application rate for pasture/rangeland was also used. • A body weight of 70 kg was assumed because the endpoint is not gender specific. The inhalation absorption rate is 100%. Baseline is long sleeve shirts, long pants, shoes plus socks, and no gloves or respirator. • Single Layer PPE includes baseline PPE with chemical resistant gloves. • Double Layer PPE includes coveralls over single layer PPE with chemical resistant gloves. PF5 indicates a filtering facepiece respirator (i.e. a dustmask) with a protection factor of 5 when properly fitted. • PF10 indicates a half mask elastomeric facepiece respirator with a protection factor of 10 when properly fitted and used with appropriate cartridges. Only closed cockpit airplanes are used for aerial application. Airplane pilots do not wear chemical resistant gloves. Handler Exposure Data Sources Handler exposure data generated by the Outdoor Residential Exposure Task Force (ORETF) were used for assessing the following lawn care operator scenarios: • Turfgun Application Mix/Load/Apply Water Dispersable Granules with a Turfgun Mix/Load/Apply Wettable Powder with a Turfgun • Mix/Load/Apply Liquids with a Turfgun • Load/Apply Granules with a Push Cyclone The remainder of the exposure scenarios were analyzed using data from the Pesticide Handlers Exposure Database (PHED). PHED was designed by a task force of representatives from EPA, Health Canada, the California Department of Pesticide Regulation, and member companies of the American Crop Protection Association. It is a software system consisting of two parts - a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals (i.e., replicates). The quality of the data and exposure factors represents the best sources of data currently available to the Agency for completing these kinds of assessments. 30 ------- c. Occupational Handler Risk Estimates and Risk Characterization Non-cancer risk estimates are expressed in terms of the Margin of Exposure (MOE), which is calculated by dividing the NOAEL by the dose. For occupationally exposed workers, MOEs greater than or equal to 100 do not exceed EPA's level of concern. Most of the mixer/loader MOEs for MCPA exceed the MOE level of concern of 100 with single layer PPE, and therefore are not of concern to the Agency. The MOE for mixing/loading liquids for aerial application to rangeland/pastures is acceptable at the MCPA Task Force rate of 2.0 Ibs ae/acre with the addition of a PF5 respirator to single layer PPE. With the exception of the right-of-way (ROW) application, the MOEs for applicators are above 100 and are not of concern. The ROW applicator scenario requires double layer PPE with PF10 respirators to achieve an acceptable MOE. The MOEs for the mixer/loader/applicator and flagger scenarios are generally acceptable with single layer PPE. A summary of the risk estimates for baseline, PPE and engineering controls is presented in Table 18. Table 18: MCPA Short/Intermediate Term MOEs for Occupational Handlers Exposure Scenario Crop or Site Application Rate (Ib/ae/acre) Acres/ Day Base- line Single Layer and Gloves Single Layer PF5 and Gloves Single Layer PF10 and Gloves Double Layer PF10 and Gloves Eng Control MOE and Gloves Mixer/Loader (M/L) M/L WP for Groundboom M/L Liquids for Aerial M/L Liquids for Groundboom M/L Liquids for ROW Sprayer Load Granulars for Broadcast Spreader Golf Courses Rangeland, Pastures Rangeland, Pastures Small Grains, Rice Flax, Peas Rangeland, Pastures Rangeland, Pastures All other Crops Golf Courses Rights of Way Golf Courses 2 4 2 1.5 0.375 4 2 0.375 to 1.5 2 4 2 40 1200 1200 1200 1200 200 200 200 40 50 40 19 0.5 1.0 1.3 5.3 3 6 >8 30 12 1900 76 29 58 77 310 170 340 >460 1700 700 1900 240 51 100 140 550 310 620 >820 3100 1200 6000 330 57 120 150 600 340 780 >910 3400 1400 8100 380 72 140 190 770 430 1400 >1200 4300 1700 12000 5700 140 280 370 1500 830 4400 >2200 8300 3300 36000 Applicator Aerial Application All Crops Above 0.375 to 4.0 1200 ND ND ND ND ND >220 ------- Exposure Scenario Groundboom Application Rights of Way Application Broadcast Spreader Application Crop or Site All Crops Above Rights of Way Golf Courses Application Rate (Ib/ae/acre) 0.375 to 4.0 4 2 Acres/ Day 40 to 200 50 40 Base- line >280 25 2400 Single Layer and Gloves >280 73 2500 Single Layer PF5 and Gloves >500 86 6900 Single Layer PF10 and Gloves >560 88 8800 Double Layer PF10 and Gloves >690 120 13000 Eng Control MOE and Gloves >1500 ND 12000 Mixer/Loader/Applicator (M/L/A) M/L/A Liquids with Backpack Sprayer M/L/A Wettable Powder with lurfgun M/L/A Liquid Flowables with lurfgun Load/Apply Granules with a Push Cyclone Spot Treatment Turf Turf Turf 4 2 2 2 4 5 5 5 ND ND ND ND 160 330 1300 220 170 690 1400 270 170 790 1400 270 270 1300 2600 420 ND 1100 ND ND Flagger Flag Aerial Application Rangeland, Pastures Rangeland, Pasture All other Crops 4 2 0.375 to 1.5 1200 1200 1200 77 150 >210 73 150 >190 110 220 >290 110 220 >300 120 240 >330 3800 7600 >10000 Mote - MOEs in bold font are below the MOE Level of Concern of 100, and therefore indicate risks of concern. d. Postapplication Occupational Risk Postapplication exposures to MCPA can occur in the agricultural environment when workers enter fields recently treated with MCPA to conduct tasks such as scouting and irrigation. MCPA is typically applied once per season and the window of time in the growing season during which applications can made is only a few weeks long. Therefore, it is anticipated that MCPA postapplication exposures would be primarily short-term and, more rarely, intermediate term. 32 ------- Only dermal exposures were evaluated in the postapplication worker assessment. Postapplication inhalation exposures are not anticipated because of the low vapor pressure of MCPA (7.7e"°6 mbar at 20 C). Postapplication oral exposures were not evaluated because the Agency currently has no policy or method for evaluating non-dietary oral ingestion by workers due to poor hygiene practices or smoking. In the Worker Protection Standard, a restricted entry interval (REI) is defined as the duration of time which must elapse before residues decline to a level so entry into a previously treated area and engaging in any task or activity would not result in exposures which are of concern. Typically, the activity with the highest risk will drive the selection of the appropriate REI for the crop. (1) Data Sources, Assumptions, and Transfer Coefficients Data Sources Data from three turf transferable residue studies submitted by the Broadleaf Turf Herbicide Task Force was used to estimate the risk to workers from the transfer of MCPA from treated turf. These studies are discussed in Section UI.A.3.C.1 of this document and in the MCPA Revised Occupational and Residential Exposure and Risk Assessment, dated June 11, 2004. With the exception of the turf transferable residue data, there were no chemical-specific data submitted to determine foliar transfer coefficients for MCPA. Therefore, the Dislodgeable Foliar Residue (DFR) was assumed to be 20% for all crops except turf. This is the standard value used in the absence of chemical specific data. Assumptions The following assumptions were made regarding postapplication occupational exposure. Risks were assessed using maximum label rates. • The transfer coefficients, as listed in Table 19, are from an interim transfer coefficient policy developed by HED's Science Advisory Council for Exposure using proprietary data from the Agricultural Re-entry Task Force (ARTF) database (US EPA, August 7, 2001). The transfer coefficients for turf harvesting and maintenance are based upon recently submitted studies discussed above. • The initial percent of application rate as Dislodgeable Foliar Residue (DFR) was assumed to be 20% for all crops except turf. These are the standard values used in the absence of chemical specific data. The Maximum TTR value (3.1 percent of the application rate) from the DMAS Treatment at the North Carolina Site was used to assess risks of working on turf in wet growing regions. • The Maximum TTR value (1.6 percent of the application rate) from the DMAS Combination Treatment at the California Site was used to assess risks of working on turf in dry growing regions. 33 ------- 34 ------- Transfer Coefficients The exposure scenarios and corresponding transfer coefficients used in the occupational postapplication assessment are presented below, in Table 19. Table 19: Post Application Exposure Scenarios and Transfer Coefficients for MCPA Crop Flax Peas Rice Small Grains Sorghum, Grain Turf, Sod Farm and Golf Course Transfer Coefficient Group 7ield/row crop, low/ medium 7ield/row crop, low/ medium 7ield/row crop, low/ medium 7ield/row crop, low/ medium 7ield/row crop, tall Turf/Sod Label Directions Post Application Exposure Scenarios Apply when flax is 2 to 8 inches tall. Do not spray once flax las reached bud stage. ^ow Exposure Scenarios - Irrigation, scouting, immature plants VIedium Exposure Scenarios - Scouting mature plants Jse only in the Pacific Northwest. Treat when peas are 4 to 6 inches tall. ^ow Exposure Scenarios - Irrigation, scouting, immature plants Vlake applications only when weeds are present and where rice s well established, 6 to 8 inches above water. Make applications no sooner than 35 and no later than 65 days after seeding or when crop stems begin to elongate. Water should not be less than 2 to 3 inches deep. Do not apply after the boot stage. ^ow Exposure Scenarios - Scouting, immature plants VIedium Exposure Scenarios - Scouting mature plants Apply after grain is fully tillered (4 to 8 inches high, but not brming joints in the stem). 3o not apply in the boot to dough stage ^ow Exposure Scenarios - Scouting, immature plants VIedium Exposure Scenarios - Scouting mature plants Apply when sorghum is 6 to 12" tall but before the boot stage. ^ow Exposure Scenarios - Scouting immature plants 7or optimum results, turf should not be mowed for 1 to 2 days after application ^ow Exposure Scenarios - Mowing -ligh Exposure Scenarios - Transplanting, hand weeding Transfer Coefficient (cm2/hr) 100 1500 100 100 1500 100 1500 100 3400 6800 35 ------- 36 ------- (2) Occupational Postapplication Risk Estimates and Risk Characterization The highest postapplication exposure risks are for small grains and rice when using the maximum label application rates. However, label language and usage information indicate that maximum rates are infrequently employed. The maximum label rate for small grains is used only for emergency control because it can damage the crop. The maximum label rate for rice is used when only one application is made as specified by a few of the labels. The remaining labels indicate that if two applications are needed, they should be made at one-half the maximum rate. The Worker Protection Standard (WPS) Restricted Entry Interval (RET) for MCPA is 12 hours for the ester form and 48 hours for the amine and sodium salt forms. There is no REI for the acid form, because the acid form is used only on non-agricultural sites (such as lawns and golf courses) that are not covered in the WPS. A summary of the occupational risks for short and intermediate term postapplication exposures is given in Table 20, below. All of the short/intermediate term MOEs are above 100 on Day 0 which indicates that the risks are not of concern. Table 20: MCPA Postapplication Worker Risks Crop 7lax >eas Small Grains, Rice Sorghum Turf Transfer Coefficient Group Field/row crop, low/medium Field/row crop, low/medium Field/row crop, low/medium Field/row crop, tall Turf - California Turf - North Carolina Short/Intermediate Term MOE on Day 0 Application Rate (Ib ae/acre) 0.375 0.375 1.5 0.75 2.0 2.0 Low Exposure Scenarios* 10000 10000 2600 5200 720 380 Medium Exposure Scenarios* 690 NA 170 1300 NA NA High Exposure Scenarios* NA NA NA NA 360 190 Task descriptions for each crop and exposure scenario are provided in the ORE Chapter. e. Human Incident Data Relatively few incidents of illness have been reported due to MCPA. Poison Control Center Data (1993 through 2001) indicated that there were relatively few exposures to products containing MCPA as the only active ingredient. Out of 28 reported exposures, 12 received follow-up to determine final medical outcome. Final medical outcome was none for three cases, minor for six, and moderate for three cases. Primary symptoms were dermal including one moderate case who reported bullae, erythema, and rash. The other two moderate cases reported difficulty breathing in one person and headache, eye irritation and 37 ------- tearing in the other. This information suggests that MCPA can be a cause of irritative effects to skin, eyes, and respiratory tract. Similar symptoms of exposure to MCPA were seen in data from California (5 incidents related to MCPA for 1982 - 2002) and in the literature. A literature search showed one fatal case, characterized as a suicide, involving a 32 year-old male who intentionally ingested 440 mg/kg and died about 20 hours after the ingestion. B. Environmental Risk Assessment A summary of the Agency's environmental risk assessment is presented below. For detailed discussions of all aspects of the environmental risk assessment, see the Revised Environmental Fate and Effects Division Preliminary Risk Assessment for the 2-methyl-4-chlorophenoxyacetic acid (MCPA) Reregistration Eligibility Decision Document (hereafter, the Revised EFED RED Document for MCPA), dated April 14, 2004. 1. Environmental Fate and Transport As discussed in Section n, four forms of MCPA are registered in the United States: acid, dimethylamine salt (DMAS), sodium salt, and 2-ethylhexyl ester (2-EHE). A detailed discussion of the environmental fate, transport, and physical-chemical properties and chemical structures of the four forms is provided in the Revised EFED RED Document for MCPA (dated April 14, 2004). For this assessment, EPA developed a bridging strategy based on the fact that MCPA DMAS, sodium salt, and 2-EHE rapidly convert to MCPA acid. Based on data submitted by the registrant that supported the bridging strategy, EPA determined that studies conducted with MCPA acid could provide surrogate data for the DMAS, sodium salt, and 2-EHE forms. In general, MCPA acid is practically insoluble in water, non-volatile, somewhat lipophilic (log K^ 2.8), and exists naturally as a solid. MCPA acid does not hydrolyze. MCPA photodegraded very slowly when applied to soil surfaces and irradiated with natural sunlight (half-life 67 days). In an aerobic soil metabolism study MCPA acid degraded with a half-life of 24 days. Under aerobic aquatic conditions, MCPA acid degraded with a total system half-life of >30 days in a water-sandy clay loam sediment systems. In laboratory batch equilibrium studies, MCPA acid was shown to be extremely mobile. 2. Water Resource Assessment Water modeling was conducted to determine potential exposure to aquatic animals. The modeling results are summarized here. Refer to the Revised EFED RED Document for MCPA for an in-depth discussion of the water models. a. Ground Water 38 ------- The Agency does not use ground water modeling information to assess exposure to aquatic animals. Residues in surface water are almost always greater than residues in ground water and therefore use of surface water models is more protective. b. Surface Water The Agency used PRZM-EXAMS to calculate refined Estimated Environmental Concentrations (EECs) for MCPA. The Pesticide Root Zone Model (PRZM, versions 3.12 and 2.98.04) simulates pesticides in field runoff, while the Exposure Analysis Modeling System (EXAMS, version 2.97-5) simulates pesticide fate and transport in an aquatic environment (one hectare body of water, two meters deep). Eight different crop scenarios were modeled, including wheat in North Dakota and Oregon, peas in Oregon, sorghum in Kansas, and rangeland/pastureland in California, Pennsylvania, and Minnesota. The standard scenario for alfalfa was used to represent rangeland/pastureland in California, Pennsylvania, and Minnesota. The alfalfa scenario was chosen because its hydrologic and agronomic practices closely match those of pasture/rangeland for which an approved scenario has not been developed. An additional non-crop scenario was run for turf in Pennsylvania. Finally, a second set of rangeland/pasture scenarios were run using the MCPA Task Force-supported use rate of 2 Ib ae/acre with 2 applications 30 days apart as opposed to a single application of 4 Ibs ae/acre which can be found on currently registered labels. These scenarios were chosen to model the concentration of MCPA in surface drinking water over a geographically dispersed range of surface water concentrations in areas representative of heavy MCPA use (i.e. northern Great Plains and northwestern US). Aquatic EECs for the ecological exposure to MCPA acid were estimated using PRZM 3.12/EXAMS 2.98 employing the small water body scenario, a Tier 2 screening model designed to estimate pesticide concentrations found in water at the edge of a treated field. As such, it provides high-end estimated values of the pesticide concentrations that might be found in ecologically sensitive environments following pesticide application. PRZM-EXAMS is a multi-year runoff model that also accounts for spray drift from multiple applications. In the ecological exposure assessment, PRZM-EXAMS simulates a 10 hectare (ha) field immediately adjacent to a one hectare small water body, 2 meters deep with no outlet. The location of the field is specific to the crop being simulated using site specific information on the soils, weather, cropping, and management factors associated with the scenario. The crop/location scenario is intended to represent a high-end exposure site on which the crop is normally grown. Based on historical rainfall patterns, the small water body receives multiple runoff events during the years simulated. The aquatic ecological exposure assessment relied on the same modeling scenarios as those used in the human health drinking water exposure assessment discussed above. Acute risk assessments are performed using peak EEC values for single and multiple applications. Chronic risk assessments for invertebrates and fish are performed using the average 21-day and 60-day EECs, respectively. Table 21 presents the PRZM/EXAMS estimated exposure concentrations (EECs) of MCPA in surface water for the eight different crop scenarios. 39 ------- Table 21: Estimated Environmental Concentrations (EECs) Simulation Scenario Crop and Location North Dakota wheat Oregon wheat California pasture California pasture Pennsylvania pasture Pennsylvania pasture Minnesota pasture Minnesota pasture Kansas sorghum Oregon peas Pennsylvania turf Application rate (ae/acre) 1.5 1.5 4 2 4 2 4 2 0.75 0.375 2.0 # Applications 1 1 1 2 1 2 1 2 1 1 1 EEC (ug ae/L) l-in-10 year Peak 11.68 9.94 18.48 14.60 23.02 21.14 16.94 22.35 13.08 4.12 5.69 21 Day Average 5.38 5.54 11.27 8.64 13.69 12.52 9.18 10.74 6.14 2.53 2.88 60 Day Average 2.72 2.57 5.60 5.48 6.69 6.53 4.71 5.27 2.61 1.18 1.36 3. Toxicity (Hazard) Assessment a. Avian, Mammalian, and Non-target Insect Toxicity Toxicity to Birds Acute toxicity tests indicate that technical MCPA is "moderately toxic" to "practically non-toxic" to birds exposed for short periods based on the submitted studies for MCPA acid and MCPA DMAS. No adverse effects were demonstrated in the avian reproduction toxicity study submitted for MCPA acid. The acute toxicity of technical grade MCPA to birds was established with two avian single-dose oral (LD50) studies on the bobwhite quail using MCPA acid and MCPA DMAS and two sub-acute dietary studies (LC50) on the mallard duck and the bobwhite quail using MCPA DMAS. No avian acute data were submitted for MCPA sodium salt or MCPA 2-EHE; these studies are not required based on the bridging strategy discussed in Section m.B. 1. Avian acute toxicity summary data for MCPA are presented in Tables 22 and 23. A single avian chronic exposure reproduction effects study was performed for MCPA using MCPA acid on bobwhite quail (Table 24). No negative effects were observed in this study; therefore, the NOAEC = 1000 mg ae/kg-diet (the highest dose tested) and the LOAEC was >1000 mg ae/kg-diet. No avian chronic data were submitted for MCPA sodium salt, MCPA DMAS, or MCPA 2-EHE; these studies are not required based on the bridging strategy discussed in Section in.B.l. 40 ------- 41 ------- Table 22: Acute Toxicity to MCPA to Birds (oral gavage administration) PC# a.i. 030501 -MCPA Acid 030516 - MCPA DMAS Salt Species Bobwhite quail Bobwhite quail % a.i. 94.6 56.4 LDjo. nig/kg-bw (conf. interval) a.i. 377 270(173,480) a.e.a 377(314,452) 221 (142, 394) Toxicity Classification (based on a.e.) moderately toxic moderately toxic " Acid equivalency calculated as: 90.3% for MCPA sodium salt, 81.7% for MCPA DMAS, and 64.1% for MCPA 2-EHE. Table 23: MCPA DMAS Salt Acute Toxicity to MCPA to Birds (dietary administration) Species Bobwhite quail Mallard duck % a.i. 56.4 56.4 LC50, mg/kg-diet (conf. interval) a.i. >5620 >5620 a.e.a >4608 >4608 Toxicity Classification (based on a.e.) practically non-toxic practically non-toxic 1 Acid equivalency calculated as: 90.3% for MCPA sodium salt, 81.7% for MCPA DMAS, and 64.1% for MCPA 2-EHE. Table 24: MCPA Chronic Toxicity to MCPA to Birds Species Bobwhite quail % a.i. 94.22 NOAEC (mg/kg-diet) a.i. 1000 a.e.a 1000 LOAEC (mg/kg-diet) a.i. >1000 a.e. >1000 Effects None " Acid equivalency calculated as: 90.3% for MCPA sodium salt, 81.7% for MCPA DMAS, and 64.1% for MCPA 2-EHE. Toxicity to Mammals Available mammalian toxicity data on laboratory mammals was used to approximate toxicity to mammalian wildlife. The portion of that data used for calculating risk quotients is summarized in Table 25. In general, toxicity tests indicate MCPA is "slightly toxic" to mammals exposed for short periods based on data submitted for MCPA acid, sodium salt, DMAS, and 2-EHE. The rat two-generation toxicity study was used for risk calculations. Adverse effects similar to those seen in the two-generation study were also demonstrated in mammalian subchronic and developmental studies. Detailed discussions of the mammalian toxicity profile for these and other studies can be found in the June 4, 2004, Revised Human Health Risk Assessment. Table 25: Mammalian Toxicity Studies Used for RQ Calculations 42 ------- Test Type 2-generation reproductive (rats) MCPA Form MCPA Acid % a.i. 94.8 NOAEC (mg/kg-diet) a.i. parental= 150 repro= 150 off spring = 450 a.e.a parental= 150 repro= 150 offspring=4 50 LOAEC (mg/kg-diet) a.i. parental= 450 repro= 450 offspring> 450 a.e. parental= 450 repro= 450 offspring >450 Effects Parental: Increased absolute and relative ovary wts (p<0.05; 23- 25% greater than controls) Repro: decreased pup weight gain during lactation Offspring: none observed Non-Target Insects Guideline toxicity tests show that MCPA is "practically non-toxic" to honey bees (Table 26). Table 26: Acute Contact Toxicity of MCPA to Non-target Insects PC# and a.i. 030516 - MCPA DMAS Salt 030564 - MCPA 2-EHE Species Honey bee Honey bee % a.i. 63.42 93.9 Toxicity endpoint a.i. LD50 > 25 • g/bee LD50 > 25 • g/bee a.e,a LD50>21 • g/bee LD 50 > 17- g/bee Toxicity classification (based on a.e.) practically non-toxic practically non-toxic " Acid equivalency calculated as: 90.3% for MCPA sodium salt, 81.7% for MCPA DMAS, and 64.1% for MCPA 2-EHE. b. Toxicity to Aquatic Animals For fish and invertebrates, most of the toxicity endpoints are within one order of magnitude when restricted to evaluating the MCPA acid, sodium salt and DMAS. The toxicity of MCPA 2-EHE tends to be two to three orders of magnitude greater than the toxicity of the acid and salts. EPA believes that the primary reason for the differences in the levels of toxicity between the ester formulation relative to the salts and acid is that esters have a greater affinity for uptake through cell wall membranes. Toxicity to Freshwater Fish No studies were submitted to the Agency evaluating toxicity of MCPA acid to freshwater fish. Toxicity studies using an end-use product for the sodium salt show that MCPA sodium salt is 'slightly toxic' to freshwater fish under acute exposure. Toxicity studies conducted using the technical and an end- use products (Rhomene) for MCPA DMAS demonstrate it is 'slightly toxic' to 'practically non-toxic' to freshwater fish under acute exposure. Toxicity tests show technical MCPA 2-EHE is 'highly toxic' to 'moderately toxic' to freshwater fish exposed for short periods of time. Toxicity to Freshwater Invertebrates 43 ------- No studies were submitted to the Agency evaluating toxicity of MCPA acid to freshwater invertebrates. A toxicity study using an end-use product for the sodium salt (Chiptox) shows that MCPA sodium salt is 'practically non-toxic' to freshwater invertebrates under acute exposure. Toxicity studies conducted using the technical product and an end-use product (Rhomene) for MCPA DMAS demonstrate it is 'slightly toxic' to 'practically non-toxic' to freshwater invertebrates under acute exposure. Toxicity tests show technical MCPA 2-EHE is 'highly toxic' to freshwater invertebrates exposed for short periods of time. One invertebrate life-cycle toxicity study was conducted for MCPA DMAS. The study on daphnids indicated a NOAEC of 11 mg ae/L and a LOAEC of 22 mg ae/L with the most sensitive parameter of reproduction. Toxicity to Estuarine/Marine Fish A toxicity study conducted using the technical product for MCPA acid demonstrates it is 'practically non- toxic' to estuarine/marine fish under acute exposure. A toxicity study conducted using an end-use product (Chiptox) for MCPA sodium salt demonstrates that it is 'practically non-toxic' to estuarine/marine fish under acute exposure. Toxicity studies conducted using the technical product and an end-use product (Rhomene) for MCPA DMAS demonstrate it is 'practically non-toxic' to estuarine/marine fish under acute exposure. Toxicity tests show technical MCPA 2-EHE is 'moderately toxic' to estuarine/marine fish exposed for short periods of time. No estuarine/marine fish chronic toxicity studies of MCPA acid, salts, or ester were submitted to the Agency. Toxicity to Estuarine/Marine Invertebrates Toxicity studies conducted using the technical for MCPA acid demonstrate it is 'practically non-toxic' to estuarine/marine invertebrates under acute exposure. Toxicity studies conducted using an end-use product (Chiptox) for MCPA sodium salt demonstrate that it is 'slightly toxic' to 'moderately toxic' to estuarine/marine invertebrates under acute exposure. Toxicity studies conducted using the technical and an end-use product (Rhomene) for MCPA DMAS demonstrate it is 'moderately toxic' to 'practically non- toxic' to estuarine/marine invertebrates under acute exposure. Toxicity tests show technical MCPA 2- EHE is 'highly toxic' to estuarine/marine invertebrates exposed for short periods of time. No estuarine/marine invertebrate chronic toxicity studies of MCPA acid, salts, or ester were submitted to the Agency. c. Toxicity to Plants Toxicity to Terrestrial Plants 44 ------- In general, toxicity tests demonstrate MCPA negatively impacts seedling emergence and vegetative vigor of terrestrial plants based on data submitted for MCPA acid, DMAS, and 2-EHE. Table 27, below, presents a summary of the endpoints used to assess risk to terrestrial plants. Table 27: MCPA Toxicity to Terrestrial Plants Organism Group Terrestrial monocots emergence Terrestrial dicots emergence Terrestrial monocots vegetative vigor Terrestrial dicots vegetative vigor MCPA Form MCPA 2-EHE MCPA DMAS MCPA 2-EHE MCPA DMAS Endpoint 0.010 EC25, Ibs ae/acre 0.005 EC25, Ibs ae/acre 0.038 EC25, Ibs ae/acre 0.004 EC25, Ibs ae/acre MCPA acid adversely affects seedling emergence and vegetative vigor of both monocots and dicots. For seedling emergence, the most sensitive monocot was onion and the most sensitive dicot was cabbage. For vegetative vigor, the most sensitive monocot was onion and the most sensitive dicots were lettuce and turnip. No terrestrial plant studies were submitted to the Agency for MCPA sodium salt. MCPA DMAS adversely affects seedling emergence and vegetative vigor of both monocots and dicots. For seedling emergence, the most sensitive monocot was ryegrass. For seedling emergence, the most sensitive dicot was cabbage. For vegetative vigor, the most sensitive moncot was onion and the most sensitive dicot was radish. MCPA 2-EHE adversely affects seedling emergence and vegetative vigor of both monocots and dicots. For seedling emergence, the most sensitive monocot was oat and the most sensitive dicot was cabbage. For vegetative vigor, the most sensitive moncot was onion and the most sensitive dicots were lettuce and radish. Toxicity to Aquatic Plants For MCPA acid, the EC50 for the Lemna gibba (freshwater vascular plant) was 0.17 mg ae/L and the NOAEC was <0.014 mg ae/L. For the three species of freshwater non-vascular plants (i.e., Selenastrum capricornutum, Naviculapelliculosa, and Anabaena flos-aquae\ the EC50s ranged from 0.63 to 6.7 mg ae/L, and the NOAECs ranged from 0.0089 to 0.47 mg ae/L. For the estuarine/marine non-vascular plant (Skeletonema costatum\ the EC50 was 0.30 mg ae/L and the NOAEC was 0.015 mg ae/L. No aquatic plant studies were submitted to the Agency for MCPA sodium salt. For MCPA DMAS, the EC50 for the Lemna gibba (freshwater vascular plant) was 0.21 mg ae/L and the NOAEC was <0.4 mg ae/L. For the three species of freshwater non-vascular plants (i.e., Selenastrum capricornutum, Navicula pelliculosa, and Anabaena flos-aquae\ the EC50s ranged from 0.16 to 99 mg 45 ------- ae/L, and the NOAECs ranged from 0.005 to 10.4 mg ae/L. For the estuarine/marine non-vascular plant (Skeletonema costatum\ the EC50 ranged from 1.2 to mg ae/L and the NOAEC ranged from 0.028 to 2.4 mg ae/L. Toxicity studies were also conducted using the technical for MCPA 2-EHE. For the Lemna gibba (freshwater vascular plant), the EC50 was 0.02 mg ae/L and the NOAEC was 0.004 mg ae/L. For the three species of freshwater non-vascular plants (i.e., Selenastrum capricornutum, Naviculapelliculosa, and Anabaena flos-aquae\ Tier n toxicity tests were conducted. The EC50's ranged from 0.17 mg ae/L to 1.3 mg ae/L, and the definitive NOAECs ranged from 0.0035 to 0.021 mg ae/L. For the estuarine/marine non-vascular plant (Skeletonema costatum\ the EC50 was 0.056 mg ae/L, and the NOAEC was <0.0019 mg ae/L. 46 ------- 4. Exposure and Risk Calculations a. Levels of Concern Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects by using risk quotients (RQs). RQs are calculated by dividing exposure estimates by acute and chronic ecotoxicity values: RQ = EXPOSURE/TOXICITY RQs are then compared with OPP's levels of concern (LOCs). These LOCs are used by OPP to analyze potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate that a pesticide, used as directed, has the potential to cause adverse effects on nontarget organisms. Risk presumptions, along with the corresponding LOCs are summarized in Table 28. The ecotoxicity test values (measurement endpoints) used in the acute and chronic risk quotients are derived from required studies. Table 28: Risk Presumptions for Terrestrial and Aquatic Animals and Plants Risk Presumption Acute Risk There is potential for acute risk; regulatory action may be warranted in addition to restricted use classification Acute Restricted Use There is potential for acute risk, but may be mitigated through restricted use classification Acute Endangered Species Endangered species may be adversely affected; regulatory action may be warranted Chronic Risk There is potential for chronic risk; regulatory action may be warranted LOG terrestrial animals 0.5 0.2 0.1 1 LOC LOC aquatic _, . , Plants animals 0.5 0.1 0.05 1 1 N/A 1 N/A b. Exposure and Risk to Nontarget Terrestrial Animals (1) Exposure to Birds and Mammals Pesticide concentrations on terrestrial food items from spray applications are based on data by Hoerger and Kenaga (1972) as modified by Fletcher et al. (1994) that determined residue levels on various terrestrial items immediately following pesticide application in the field. Specifically, for every 1 Ib ai/acre of application, the resulting maximum concentration on short grass is 240 ppm, on tall grass is 110 ppm, on broad-leaved plants/small insects is 135 ppm, and on seeds/large insects is 15 ppm. For every 1 Ib ai/acre 47 ------- of application, the resulting mean concentration on short grass is 85 ppm, on tall grass is 36 ppm, on broad-leaved plants/small insects is 45 ppm, and on seeds/large insects is 7 ppm. Pesticide concentrations on food items following multiple applications are predicted using a first-order residue decline method, OPP's "FATES" model, which allows determination of residue dissipation overtime incorporating degradation half-life. Predicted maximum and mean EECs resulting from multiple applications are calculated from the FATES program. FATES estimates the highest one-day residue, based on the maximum or mean initial EEC from the first application, the total number of applications, interval between applications, and a first-order degradation rate, consistent with OPP policy. For MCPA, the registrant has submitted several studies under Guideline 860.1500 which allow the estimation of foliar residue half-lives. Half-lives for each study were estimated using non-linear regression with an exponential decay model and ranged from 1.6 to 5.8 days. The mean residue half-life was 3.0 days and the upper 90th confidence limit for the mean was 3.4 days. EPA will use the upper 90th confidence limit for the mean to calculate residue for multiple applications. Birds and mammals may be exposed to granular pesticides when foraging for food or grit. They also may be exposed by other routes, such as by walking on exposed granules or drinking water contaminated by granules. The exposure to granules is estimated as milligrams ae per square foot of treated ground using the maximum application rate of 0.124 Ibs ae/5000 sq. ft (EPA Label # 228-203). (2) Avian Risk In the avian acute dietary studies that were submitted to the Agency, no mortalities were observed. Therefore, RQs based on these dietary studies were not calculated to evaluate the potential acute risks (i.e., Acute Endangered, Acute Restricted Use, and Acute Risk) to birds because of a high, unqualified LC50 (> 4608 mg ae/kg-diet). Negative effects were observed in the submitted studies (reduced feed consumption and body weight gain), and the NOAECs were established at 820 mg ae/kg-diet for the bobwhite quail and 461 mg ae/kg-diet for the mallard duck. Acute risk based on mortality in the dietary studies is low. Since mortality was observed in the acute gavage studies, acute avian RQs were calculated using the acute gavage studies. The most sensitive LD50 was 221 mg ae/kg-bw (MCPA DMAS for bobwhite quail, MRID 40019202). The RQ calculations for the maximum labeled application rate (4.0 Ibs ae/acre), the maximum labeled application rate for wheat (1.5 Ibs ae/acre), and the application rate of 2.0 Ibs ae/acre/app with two applications 30 days apart are summarized in Table 29. Assuming maximum application rates (4.0 Ibs ae/acre either as a single or split application) and maximum residue levels for all weight classes and food stuffs, RQs range from 0.01 to 6.6. Assuming maximum application rates and predicted mean residues, RQs range from 0.01 to 2.33. 48 ------- Assuming maximum application rates on wheat (1.5 Ibs ae/acre) and maximum residue levels for all weight classes and food stuffs, the RQs range from 0.01 to 2.46. Assuming maximum application rates on wheat and predicted mean residues, the RQs range from <0.01 to 0.88. Assuming maximum residue levels at the maximum application rate, no Chronic Risk LOCs were exceeded for short grass, tall grass, and broadleaf forage/small insects. RQs range from 0.1 to 1.00. Since there were no exceedances at the highest application rate, chronic RQs for lower application rates were not calculated for this assessment. Table 29: Avian Acute Risk Quotient Summary (Predicted Mean Residues) Food Type short grass tall grass broadleaf forage, small insects seeds, pods Weight Class (g) 20 100 1000 20 100 1000 20 100 1000 20 100 1000 4 Ibs ae/acre 2.33 1.04 0.33 0.99 0.44 0.14 0.89 0.40 0.13 0.04 0.02 0.01 2 Ibs ae/acre/app, 2 apps 30 days apart 1.16 0.52 0.17 0.49 0.22 0.07 0.45 0.20 0.06 0.02 0.01 <0.01 1.5 Ibs ae/acre 0.88 0.39 0.12 0.37 0.17 0.05 0.34 0.1 0.05 0.02 0.01 <0.01 RQ > 0.10 indicates an exceedance of Endangered Species Level of Concern (LOG) RQ > 0.20 indicates an exceedance of Acute Restricted Use LOG. RQ > 0.50 indicates an exceedance of Acute Risk LOG. Assuming maximum granular application rates (1.09 Ibs ae/acre), there were no LOG exceedances as all calculated RQs were < 0.01. EPA does not currently assess chronic risks to birds from granular applications. (3) Risk to Mammals To evaluate the acute risk to mammals, RQs were calculated using the minimum LD50 obtained from the acute oral studies (1383 mg ae/kg-bwt, MCPA acid, Ace. 21972) at the maximum labeled rate (4 Ibs ae/acre) the maximum labeled application rate for wheat (1.5 Ibs ae/acre), and the application rate of 2.0 Ibs ae/acre with 2 applications 30 days apart. To evaluate the chronic risk to mammals, RQs were calculated using the NOAEC obtained from the 2-generation rat study with MCPA acid (NOAEC=150 mg ae/kg-diet, MRID 400417-01). The RQ values calculated at predicted mean residues are summarized in Tables 30 and 31. 49 ------- Assuming maximum residue levels at the maximum single application rate (4.0 Ibs ae/acre) for all weight classes and food stuffs, acute RQs ranged from < 0.01 to 0.63. Assuming predicted mean residue levels at the maximum single application rate, the acute RQs ranged from < 0.01 to 0.22. Assuming maximum residue levels at the application scenario of 2.0 Ibs ae/acre/app for two applications 30 days apart for all weight classes and food stuffs, acute RQs ranged from 0.32 to < 0.01. Assuming mean residue levels, the RQs range from < 0.01 to 0.11. Assuming maximum residue levels at the maximum single application rate for wheat (1.5 Ibs ae/acre) for all weight classes and food stuffs, acute RQs ranged from < 0.01 to 0.24. Assuming mean residues, RQs ranged from < 0.01 to 0.08. Assuming the maximum labeled application rate (4.0 Ibs ae/acre) and maximum residue levels for all weight classes and food stuffs, chronic RQs ranged from 0.40 to 6.40. Assuming mean predicted residues, the chronic RQs ranged from 0.19 to 2.27. Assuming maximum residue levels at the application scenario of 2.0 Ibs ae/acre/app for two applications 30 days apart for all weight classes and food stuffs, the chronic RQs range from 0.20 to 3.21. Assuming mean residues, RQs range from 0.09 to 1.13. Assuming the maximum labeled application rate for wheat (1.5 Ibs ae/acre) for maximum residue levels for all weight classes and food stuffs, the chronic RQs range from 0.15 to 2.40. Assuming mean residues, chronic RQs range from 0.07 to 0.85. Table 30: Mammalian Acute Risk Quotient Summary (Predicted Mean Residues) Food type short grass tall grass broadleaf forage, small insects seeds, pods Weight class (g) 15 35 1000 15 35 1000 15 35 1000 15 35 1000 4 Ibs ae/acre 0.22 0.15 0.04 0.09 0.07 0.02 0.09 0.06 0.01 <0.01 0.01 <0.01 2 Ibs ae/acre/app, 2 apps 30 days apart 0.11 0.08 0.02 0.05 0.03 0.01 0.04 0.03 0.01 0.01 0.01 O.01 1.5 Ibs ae/acre 0.08 0.06 0.01 0.04 0.02 0.01 0.03 0.02 0.01 0.01 0.01 O.01 RQ > 0.10 indicates an exceedance of Endangered Species Level of Concern (LOG) RQ > 0.20 indicates an exceedance of Acute Restricted Use LOG RQ > 0.50 indicates an exceedance of Acute Risk LOG Table 31: Mammalian Chronic Risk Quotient Summary (Predicted Mean Residues) Food type short grass tall grass 4 Ibs ae/acre 2.27 0.96 2 Ibs ae/acre/app, 2 apps 30 days apart 1.13+ 0.48 1.5 Ibs ae/acre 0.85 0.36 50 ------- Food type broadleaf forage, small insects fruit, large insects, seeds, pods 4 Ibs ae/acre 1.20+ 0.19 2 Ibs ae/acre/app, 2 apps 30 days apart 0.60 0.09 1.5 Ibs ae/acre 0.45 0.07 RQ > 1.0 indicates an exceedance of Chronic LOG Assuming maximum granular application rates (1.09 Ibs ae/acre) there were no LOG exceedances as all calculated RQs were < 0.01. OPP does not currently assess chronic risks to mammals from granular applications. (4) Risk to Insects OPP currently does not quantify risks to terrestrial non-target insects; therefore, risk quotients are not calculated for these organisms. Since MCPA is practically non-toxic to honey bees (LD50 of >17 ug/bee), the potential for MCPA to have adverse effects on pollinators and other beneficial insects is low. 5. Exposure and Risk to Nontarget Aquatic Animals Risks to aquatic fish and invertebrates were assessed using modeling with PRZM/EXAMS to estimate aquatic exposure due to runoff and spray drift. Overall, drift was a minor component when compared to runoff. The assessment of runoff and spray drift of MCPA acid and amine salts, showed no exceedances of any LOG for aquatic fish and invertebrates. For MCPA ester assessment of runoff with spray drift, there were mixed exceedances of endangered species LOG with RQs ranging from 0.05 to 0.07 for freshwater invertebrates for the North Dakota wheat, Oregon wheat, Pennsylvania pasture, and Minnesota pasture scenarios. a. Exposure and Risk to Nontarget Plants (1) Risk to Terrestrial Plants For terrestrial plants, an analysis of the results indicates exceedance of the Acute Risk LOG and the Acute Endangered Species LOG for all modeled scenarios at the highest application rate (Table 32, below). At the highest labeled rate for wheat (1.5 Ibs ae/acre), all Acute Endangered Species LOCs were exceeded, and all Acute Non-endangered Species LOCs were exceeded except for drift to non-target monocots from ground application. At the highest labeled rate for granular applications (1.09 Ibs ae/acre), all Acute Endangered Species LOCs and all Acute Non-endangered Species LOCs were exceeded. Currently, OPP does not perform chronic risk assessments for terrestrial plants. 51 ------- Table 32: Summarized Terrestrial Plant Risk Quotients Scenario (Appl. rate) Ground spray application (4.0 Ibs ae/acre) Aerial or chemigation spray application (4.0 Ibs ae/acre) Ground spray application (1.5 Ibs ae/acre) Aerial or chemigation spray application (1.5 Ibs ae/acre) Granular ground application (1.0 9 Ibs ae/acre) a Plant Type Monoco t Dicot Monoco t Dicot Monoco t Dicot Monoco t Dicot Monoco t Dicot Acute Non-endangered RQs adjacent to treated sites 24.00 48.00 32.00 64.00 9.00 18.00 12.00 24.00 5.45 10.90 semi-aquatic areas 204.00 408.00 140.00 280.00 76.50 153.00 52.50 105.00 54.50 109.00 drift 1.05 10.00 5.26 50.00 0.39 3.75 1.97 18.75 NA NA Acute Endangered RQs adjacent to treated sites 40.00 40.00 53.33 53.33 15.00 15.00 20.00 20.00 9.08 9.08 semi-aquatic areas 340.00 340.00 233.33 233.33 127.50 127.50 87.50 87.50 90.83 90.83 drift 3.08 13.33 15.38 66.67 1.15 5.00 5.77 25.00 NA NA a RQs for ground granular applications in this table were calculated for the maximum labeled application rate of 1.09 Ibs ae/acre. RQs for other application rates are a linear function of the listed RQs. Drift RQs are not applicable for granular applications. (2) Risk to Aquatic Plants Similar to aquatic organisms, risks to aquatic plants were assessed using modeling with PRZM/EXAMS to estimate aquatic exposure due to runoff with spray drift of MCPA acid, amine salts and ester. For the first scenario, assessment of runoff with spray drift of MCPA acid and amine salts, there were no exceedances of any LOG for the non-endangered plants. However, there were exceedances of the acute endangered freshwater vascular plant for several scenarios, as presented in Table 33, below. Table 33: Endangered Species Aquatic Plants exposed to MCPA acid and amine salts via runoff and drift Scenario CA pasture CA pasture JA pasture JA pasture Rate One application at 4.0 Ibs/acre Two applications at 2.0 Ibs/acre One application at 4.0 Ibs/acre Two applications at 2.0 Ibs/acre RQ 1.42 1.12 1.77 1.62 52 ------- Scenario VIN pasture VIN pasture •CS sorghum lice Rate One application at 4.0 Ibs/acre Two applications at 2.0 Ibs/acre One application at 0.75 Ibs/acre One application at 1.25 Ibs/acre RQ 1.30 1.72 1.01 94 For the second scenario, assessment of runoff with spray drift of the MCPA ester, there were no exceedances of any LOG for the non-endangered plants. However, there were exceedances of the acute endangered freshwater vascular plant for several scenarios, as presented in Table 34, below. Table 34: Endangered Species Aquatic Plants exposed to MCPA ester via runoff and drift Scenario ND wheat OR wheat C A pasture PA pasture PA pasture MN pasture MN pasture PA turf Rate One application at 1.5 Ibs/acre One application at 1.5 Ibs/acre Two applications at 2.35 Ibs/acre One application at 2.35 Ibs/acre Two applications at 1.315 Ibs/acre One application at 2.35 Ibs/acre Two applications at 1.315 Ibs/acre One application at 1.75 Ibs/acre RQ 3.18 2.43 1.65 2.90 1.45 2.25 1.13 1.40 6. Ecological Incidents There are several reported incidents in the Environmental Incident Information System (EHS) database with a terrestrial organism effect. All were crop injury incidents. There are no reported incidents involving the use of MCPA alone, with the exception of the accidental misuse. All other reported incidents involve co-formulated products in which the damage may have been caused by MCPA and/or the other active ingredients in the products. In North Dakota, Bronate Advanced, co-formulated with MCPA 2-EHE, bromoxynil octanoate, and bromoxynil heptanoate, was reported to have damaged 880 acres of spring wheat when applied in 2002 (#1013430-023,1013430-024,1013103-029). In North Dakota, DAKOTA, co-formulated with MCPA 2-EHE and fenoxaprop-p-ethyl, was reported to have damaged 150 acres of spring wheat when applied in 2000 (#1010472-093). In Canada, Curtail, co-formulated with MCPA 2-EHE and clopyralid, is alleged to have caused crop injury to 20,000 acres of peas, chick peas, and lentils planted in 2002. This was reported as a carry-over injury as Curtail had been applied to barley, oats, and wheat that were grown in those fields in 2001 (#1013636-008). 53 ------- In Wisconsin, MCPA AMFNE 4, formulated with MCPA DMAS, was reported to have killed 28.8 acres of alfalfa and oats when applied in excess of the labeled application rate in 2001 (#1012242-001). 54 ------- 7. Endangered Species The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA puts basic toxicity and exposure data developed for reregistation eligibility decisions into context for individual listed species and their locations by evaluating important ecological parameters, pesticide use information, the geographic relationship between specific pesticide uses and species locations and biological requirements and behavioral aspects of the particular species. A determination that there is a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/or the National Marine Fisheries Service as necessary. Based on EPA's screening level assessment, RQs exceed levels of concern for MCPA use sites for endangered species of mammals, birds, aquatic plants, and terrestrial plants. These findings are based solely on EPA's screening level assessment and do not constitute "may affect" findings under the Endangered Species Act. The Agency is requiring application rate reductions and additional mitigation to minimize these LOG exceedances, and is requiring additional data to further characterize and refine its ecological and endangered species risk assessments. 8. Risk Characterization a. Terrestrial Animal Risk Characterization Using the acute dietary bird toxicity studies, risks for acute lethal concerns to birds are low, as no mortality was observed at the highest dose. However, based on the acute toxicity studies submitted for birds, there is a large differential between the acute toxicity when MCPA is administered as a single gavage or when mixed in the feed. This disparity in mortality between the two studies suggests that the dietary matrix may have a lowering effect of the toxicity of MCPA. Although the concerns for lethality of MCPA to non- endangered birds is minimal, it is likely that the current maximum label rates could have adverse non-lethal effects on birds, especially those consuming short grasses. Risks to endangered bird species including sublethal effects and lethal effects still exist due to the uncertainty in variability among species sensitivities. These risks would be greatest in short grass consumers, primarily smaller birds. Risk of adverse chronic effects to birds is not expected. Although there were exceedances of the acute LOCs for mammals using predicted maximum residue levels and predicted mean residue levels at the maximum application rates, the risk assessment and calculated RQs assume 100% of the diet is relegated to single food types foraged only from treated fields. The assumption of 100% diet from a single food type may be somewhat more realistic for acute exposures, but 55 ------- diets are likely to be more variable over longer periods of time depending on size and forage range of the animals. Other exposure routes are possible for animals residing in or moving through treated areas. These routes include ingestion of contaminated drinking water, ingestion of contaminated soils, preening/grooming, and dermal contact. Preening exposures, involving the oral ingestion of material from the feathers remains an unquantified, but potentially important, exposure route. If toxicity is expected through any of these other routes of exposure, then the risks of a toxic response to MCPA is underestimated in this risk assessment. b. Aquatic Organism Risk Characterization The predicted peak MCPA acid concentrations based on the PRZM/EXAMS model for the ecological risk assessment are comparable to the highest annual maximum concentration of MCPA acid (18.58 jig ae/L) in the surface water monitoring data from NAWQA. The predicted PRZM/EXAMS chronic MCPA acid concentrations (21-day and 60-day average concentrations) are comparable to the maximum time- weighted mean concentration of MCPA acid (1.49 jig ae/L) of the surface water monitoring data from NAWQA. Although the monitoring results support the modeling estimates, it is important to note that none of the monitoring data was targeted to MCPA usage and no degradates of MCPA are included in the data that were evaluated. Of the formulations for which toxicity data are available, the salts and acid form of MCPA ranged from 'practically non-toxic' to 'moderately' toxic to fish and invertebrates. MCPA 2-EHE was 'moderately toxic' to 'highly toxic' to fish and invertebrates. Although toxicity categories for the salts and acid form of MCPA ranged from practically non-toxic to highly toxic, no Acute Risk LOCs were exceeded under any of the modeled scenarios. Toxicity data for MCPA EHE ranged from 'moderately toxic' to 'highly toxic' to fish and invertebrates. The Endangered Species LOG for estuarine invertebrates in the California and the Pennsylvania pasture (single application) scenarios was exceeded in the scenarios modeling MCPA 2-EHE reaching the water body through drift only in the ester form. However, at this time there are no federally listed endangered estuarine or marine invertebrates. However, for scenarios when MCPA 2-EHE is applied and it is assumed that the substance reaches the water in the 2-EHE form through both runoff and drift, there were several exceedances of the Endangered Species LOG for freshwater and estuarine invertebrates. Since there are no federally listed endangered estuarine/marine invertebrates, The Agency does not have concerns for these Endangered Species LOG exceedances at the present time. However, if MCPA 2-EHE does reach waterbodies through both runoff and drift, several Endangered Species screening level LOG exceedances could occur for freshwater invertebrates. Based on the available information for MCPA, chronic risks to freshwater fish and invertebrates are low. OPP inferred that chronic risks to estuarine/marine fish and invertebrates would also be low under the 56 ------- assumption that the acute-to-chronic ratio of toxicity endpoints would hold constant across freshwater and estuarine/marine organisms. There are several uncertainties inherent in the aquatic organism risk assessment. Some of these uncertainties could lead to underestimates of risk, while others could lead to overestimates of risk. These and other uncertainties are discussed fully in the Revised EFED MCPA RED Document (dated April 14, 2004). One notable uncertainty is that this assessment accounts only for exposure of aquatic organisms to MCPA, but not to its degradates. The potential toxicity of degradates of MCPA is unknown. c. Terrestrial and Aquatic Plant Risk Characterization Risks to Terrestrial Plants The risk quotient calculations suggest concern for non-target terrestrial plants across all use sites at the highest application rate (4.0 Ibs ae/acre); the Acute Endangered Terrestrial Plant RQs and the Acute Non- Endangered Terrestrial Plant RQs exceeded the LOG for all the modeled scenarios. At the highest labeled rate for wheat (1.5 Ibs ae/acre), the Acute Endangered LOCs and Acute Non-endangered LOCs were exceeded for all except for drift to non-target non-endangered monocots from ground application. For MCPA, a total of 60 terrestrial plant studies were submitted using various formulations and species. Typically, The Agency evaluates risk to non-target terrestrial plants using the EC25s for the most sensitive species tested from the seedling emergence studies and from the vegetative vigor studies. In order to test the conservativeness of this approach, The Agency evaluated the full range of EC25 results. The 52 definitive EC25s obtained in all the terrestrial plant studies ranged from 0.004 Ib ae/acre to 2.0 Ibs ae/acre. If the 75th percentile of the definitive EC25s (0.096 Ibs ae/acre) is used as the toxicity endpoint, to calculate non-endangered non-granular RQs, all RQs (range from 2.50 to 21.25) exceeded an LOG of 1.0 for adjacent terrestrial and semi-aquatic non-target plants at an application rate of 4.0 Ibs ae/acre. For drift from ground spray, the RQ for non-target plants was 0.42 and for drift from aerial application, the RQ for non-target plants was 2.08. This indicates that although there is a range of plant sensitivities to MCPA, a majority of the tested species have a high sensitivity to MCPA; therefore, this assessment for terrestrial plants is not overly conservative. MCPA uptake is primarily through the foliage and it is translocated throughout the plant in the xylem and phloem. Uptake also occurs through the roots. Even if only a small surface area of the plant is exposed to MCPA, or a seedling is exposed to MCPA as it breaks through the soil surface, there is a possibility that the plant may be severely damaged or die as a result. The resulting damage, even if only minor, may be sufficient to prevent the plant from competing successfully with other plants for resources and water. Spray drift is also an important factor in characterizing the risk of MCPA to non-target plants. There is as much as a 5-fold increase in the RQs when aerial application is used as opposed to ground application. 57 ------- Concerns have also been raised regarding the higher volatility of the phenoxy esters, relative to the phenoxy amine salts, as this may increase off-target damage to plants through volatilization and subsequent drift. Only four of the EC2sS and 13 of the NOAECs from the 60 available plant (seedling and vegetative vigor) studies for all formulations of MCPA were less than 0.009 Ibs ae/acre, indicating volatilization alone is not a major factor in non-target plant exposure to MCPA 2-EHE. The risk assessment for terrestrial plants was based on RQs calculated from toxicity studies using the technical grade of MCPA acid, salt, and esters instead of TEPs (typical end-use product). Often the TEPs include surfactants or adjuvants to increase the herbicide's adsorption into the plant, thereby increasing its efficacy. If the toxicity tests were conducted using a TEP of MCPA at the same rates as the technical grade, the toxicity endpoints are likely to be much lower. Risks to Aquatic Plants There were no acute risk exceedances for aquatic plants. However, several exceedances of the Endangered Species LOG (freshwater vascular plants only) occurred under the different modeling scenarios. As with the invertebrates, these RQs were calculated using the maximum labeled application rates. However, for many crops, the average application rate is much lower than the maximum labeled rate. For the 2-EHE drift/runoff modeling, the RQs for freshwater vascular endangered plants are below the Acute Endangered LOCs at an application rates of 0.47 Ibs ae/acre/yr for wheat, 0.81 Ibs ae/acre/yr for pasture, and 1.25 Ibs ae/acre/yr for turf. The average application rates for wheat and pasture are 0.37 and 0.39 Ibs ae/acre/yr. For the 2-EHE drift only modeling, when the pasture and wheat application rates were modeled at a single application of 1.4 Ibs ae/acre/yr the RQs for freshwater vascular aquatic plants were below the Endangered Species LOG. All the toxicity endpoints on which the RQs were based were estimated from studies in which the technical form of MCPA was used. Often in many end-use products, surfactants and adjuvants are added to increase the effect of the active ingredient. If end-use products containing MCPA also contain these performance-enhancing inert ingredients and these inerts also reach the non-target aquatic plant species, this quantitative risk assessment may underestimate the risks. IV. Risk Management, Reregistration and Tolerance Reassessment A. Determination of Reregistration Eligibility Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient, whether or not products containing the active ingredient are eligible for reregistration. The Agency has previously identified and required the submission of the generic (i.e., active ingredient-specific) data required to support reregistration of products containing the active ingredient MCPA. 58 ------- The Agency has completed its assessment of the dietary, occupational, residential, and ecological risk associated with the use of pesticide products containing the active ingredient MCPA. Based on a review of these data and on public comments on the Agency's assessments for the active ingredient MCPA, EPA has sufficient information on the human health and ecological effects of MCPA to make decisions as part of the tolerance reassessment process under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency has determined that MCPA products are eligible for reregistration provided that: (i) current data gaps and confirmatory data needs are addressed; (ii) the risk reduction measures outlined in this document are adopted; and (iii) label amendments are made to reflect these measures. Label changes are described in Section V. Appendix A summarizes the uses of MCPA that are eligible for reregistration. Appendix B identifies the generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of MCPA, and lists the submitted studies that the Agency found acceptable. Data gaps are identified as generic data requirements that have not been satisfied with acceptable data. Based on its evaluation of MCPA, the Agency has determined that MCPA products, unless labeled and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this document, the Agency may take regulatory action to address the risk concerns from use of MCPA. If all changes outlined in this document are incorporated into the product labels, then all current risks for MCPA will be adequately mitigated for the purposes of this determination. B. Public Comments and Responses When making its reregistration decision, the Agency took into account all comments received after the opening of the public docket. Three such comments were received, from the California Regional Water Quality Control Board, the National Barley Growers Association, and a private citizen. These comments are available, in their entirety, from the docket (Docket # OPP-2004-0156). The California Regional Water Quality Control Board's comments recommended that EPA conduct a cumulative ecological risk assessment for phenoxy herbicides. At this time, however, OPP does not have a process for quantitatively assessing the cumulative ecological effects of pesticides; the best available science lacks the supporting data toxicity and exposure tools to conduct cumulative assessments for pesticides in the ambient environment. The National Barley Growers Association's comments were in support of the reregistration of MCPA, specifically noting the importance of the pesticide's use on barley. EPA did not receive formal comments from the registrants during the public comment period. However, EPA's response to the comments received from the MCPA Task Force Three during the 30-day registrant error-only correction period are available in the public docket (Docket # OPP-2004-0156). C. Regulatory Position 59 ------- 1. FQPA Assessment a. "Risk Cup" Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with MCPA. EPA has determined that risk from dietary (food sources only) exposure to MCPA is within its own "risk cup." An aggregate assessment was conducted for exposures through food, drinking water, and residential uses. The Agency has determined that the human health risks from these combined exposures are within acceptable levels. In other words, EPA has concluded that the tolerances for MCPA meet the FQPA safety standards. In reaching this determination, EPA has considered the available information on the special sensitivity of infants and children, as well as the chronic and acute food exposures. In addition, this determination is based on a revised database uncertainty factor analysis (described below in Section IV.C.l.c), in addition to a new dermal absorption study (see Section IV.D) and lower application rates. b. Determination of Safety for U.S. Population EPA has determined that the established tolerances for MCPA, with amendments and changes as specified in this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general population. In reaching this determination, EPA has considered all available information on the toxicity, use practices and scenarios, and the environmental behavior of MCPA. As discussed in chapter 3, the total acute dietary (food alone) risk from MCPA is below the level of concern as is the chronic risk from food alone. Risks from drinking water exposures are also not of concern. Risks from residential and occupational exposures are also not of concern based on rate reduction and other mitigation measures, as well as a reassessment of the appropriate database uncertainty factor, as described below, and a new dermal absorption study. (See also additional discussion in Section IV.D.l of this document [Regulatory Rationale, Human Health Risk Mitigation].) c. Determination of Safety for Infants and Children EPA has determined that the established tolerances for MCPA, with amendments and changes as specified in this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers the factors noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of MCPA residues in this population subgroup. FQPA directs EPA, in setting pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children, taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology and exposure databases. The statute authorizes EPA to replace this tenfold FQPA safety 60 ------- factor with a different FQPA factor only if reliable data demonstrate that the resulting level of exposure would be safe for infants and children. FQPA Special Safety Factor In determining whether infants and children are particularly susceptible to toxic effects from MCPA residues, EPA considered the completeness of the database for developmental and reproductive effects, the nature of the effects observed, and other information. The FQPA Safety Factor for protection of children and infants was removed for two reasons: (1) there are acceptable developmental and reproduction studies that have been submitted and reviewed; and (2) there is no evidence of increased pre- or post-natal susceptibility except in a rat developmental toxicity study with MCPA 2-EFffi. OPP performed a Degree of Concern Analysis because there was evidence of increased susceptibility of the young following exposure to MCPA 2-EHE in a rat developmental study. After consideration of the study design, the Agency concluded that qualitative susceptibility was demonstrated because increased incidence of decreased fetal body weight, altered growth, and increased litter resorption were found at doses where maternal toxicity (decreased body weight gain) was also found. However, OPP characterized the degree of concern for the effects in this study as low, based on consideration of the doses and endpoints selected for risk assessment and the overall toxicity profile for MCPA. OPP further noted that the developmental study was well-conducted, that clear NOAELs/LOAELs were established, that the dose response for the observed effects is well characterized, and that the developmental NOAEL of 40 mg/kg/day identified in the study was used to establish the acute Reference Dose (aRfD) for the Females 13-50 population subgroup. Based on all of these considerations, the Agency concluded that the default Special FQPA Safety Factor is not required. Database Uncertainty Factor The Agency has concluded that a developmental neurotoxicity study on MCPA 2-EFffi is necessary to further characterize the potential for pre-natal neurotoxicity due to the presence of clinical signs indicative of neurotoxicity in acute and subchronic studies. The MCPA toxicology database does not include a DNT study, and therefore a Database Uncertainty Factor is necessary to be protective of children. This Uncertainty Factor is applied only to exposure scenarios that are expected for children or pregnant women, and thus is not applied to occupational exposure scenarios. Subsequent to public release of the revised risk assessment for MCPA, the Agency reevaluated the appropriate size of the Database Uncertainty Factor. The NOAEL from an acceptable reproduction study was compared to a dose level that the Agency assumes would be the NOAEL from a DNT study, when completed. The Agency has assumed that if a DNT study were conducted, the NOAEL from that study would be similar to the lowest dose tested in the reproduction study. The assumption is based on an analysis of data from DNT studies previously submitted to the Agency which suggests that NOAELs lower than the lowest dose tested in the reproduction study are unlikely to occur. 61 ------- In the case of MCPA, the lowest dose tested in the rat reproduction study (MRID 40041701) is 2.5 mg/kg/day. The Agency therefore assumes that a DNT study on MCPA would yield a NOAEL of approximately 2.5 mg/kg/day. EPA's determination of the size of the Uncertainty Factor is based on a comparison between the assumed DNT NOAEL of 2.5 mg/kg/day and the endpoints used in the risk assessments. The approximate size of the Database Uncertainty Factor is derived by dividing the point of departure used for each exposure pathway by the assumed DNT NOAEL of 2.5 mg/kg/day. Applying this dose analysis to MCPA, a 10X Database Uncertainty Factor is required for acute dietary scenarios (including acute incidental oral exposure), based on a comparison between the developmental NOAEL of 40 mg/kg/day and the assumed DNT study NOAEL of 2.5 mg/kg/day. A 10X Database Uncertainty Factor is also required for acute residential dermal scenarios, based on a comparison between the oral equivalent NOAEL of 40-50 mg/kg/day and the assumed DNT study NOAEL of 2.5 mg/kg/day. A 3X Database Uncertainty Factor is required for residential short-term and intermediate dermal exposure scenarios, based on a comparison between an oral equivalent NOAEL of 7 mg/kg/day and the assumed DNT study NOAEL of 2.5 mg/kg/day. The Agency has determined that a IX Database Uncertainty Factor is appropriate for chronic dietary exposure, incidental oral exposure, long term dermal exposure, short- and intermediate-term occupational dermal exposures, and all durations of inhalation exposure because the endpoints used for these assessments, a NOAEL of 4.4 mg/kg/day, is of the same order of magnitude of the assumed DNT study NOAEL (2.5 mg/kg/day) and in a similar dose range. Table 35, below, summarizes the revised Database Uncertainty Factors for MCPA. The Agency believes that with the application of the Database Uncertainty Factors discussed in this section, the regulatory endpoints are protective of children despite the need for a developmental neurotoxicity study. EPA is, however, still requiring the registrants to conduct a DNT study on the MCPA 2-EHE as a condition of reregistration. Results from this study will allow EPA to further characterize the potential for pre-natal neurotoxicity from the MCPA 2-EHE formulation. Table 35: Summary of MCPA Revised Database Uncertainty Factors Exposure Scenario Acute Dietary Chronic Dietary Acute Incidental Oral Short-term Incidental Oral Acute Dermal Short- and Intermediate-term Dermal Inhalation (short-, intermediate-, & long-term) Previous Database ,-•• / // ~ ,-• > x - tJite|rtainty Factor 10X 10X 10X 10X Residential = 10X Occupational = IX Residential = 10X Occupational = IX Residential = 10X Occupational = IX New Database • •• • - Uncertainty Factor 10X IX 10X* IX Residential = 10X* Occupational = IX Residential = 3X Occupational = IX IX * The Database Uncertainty Factor is 10X because the endpoint used is derived from an acute dietary study which requires a 10X Database Uncertainty Factor. 62 ------- d. Endocrine Disrupter Effects EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other endocrine effects as the Administrator may designate." Following recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the EDSP have been developed, MCPA may be subject to additional screening and/or testing to better characterize effects related to endocrine disruption. e. Cumulative Risks The Food Quality Protection Act (FQPA) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to MCPA and any other substances, and MCPA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that MCPA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. f. Tolerance Summary Tolerances have been established under 40 CFR §180.339(a) for residues of MCPA (2-methyl-4- chlorophenoxyacetic acid) per se in/on various plant commodities, and tolerances are established under 40 CFR §180.339(b) for the combined residues of MCPA and its metabolite 2-methyl-4-chlorophenol in livestock commodities. 63 ------- Plant Commodities OPP has determined that the residues to be regulated for risk assessment purposes in plant commodities are free and conjugated MCPA and its metabolite 2-HMCPA [(4-chloro-2-hydroxymethylphenoxy)acetic acid]. In the June 3, 2004, Residue Chemistry Chapter, EPA concluded that the metabolite CCPA [(4- chloro-2-carboxyphenoxy)acetic acid] should also be regulated for risk assessment purposes. However, based on additional information submitted by the registrant during risk mitigation discussions in August 2004, OPP concluded that CCPA is not a metabolite of concern. This conclusion is reflected in the Residue Chemistry Chapter for MCPA, dated September 14, 2004. The residues to be regulated for tolerance reassessment purposes are MCPA, per se. The MCPA tolerance expression for plant commodities at 40 CFR §180.339(a) includes several forms of MCPA that either no longer correspond to registered manufacturing use or end use products or which are not supported for reregistration. As a result, the following salts and esters will be deleted from the tolerance expression: ethanolamine salt, diethanolamine salt, triethanolamine salt, isopropanolamine salt, diisopropanolamine salt, triisopropanolamine salt, isooctyl ester, and butoxyethyl ester. Furthermore, the 2-ethylhexyl ester (2-EHE) form will be added to the tolerance expression. The form 2-ethylhexyl ester more accurately identifies the isooctyl ester group associated with MCPA, and all but one of the products previously registered under the active ingredient name MCPA isooctyl ester are now registered as 2-EFIE products. It should be noted that the chemical name for MCPA has been presented both as "(2-methyl-4- chlorophenoxy)acetic acid" and "(4-chloro-2-methylphenoxy)acetic acid." Although both names are correct, the "(4-chloro-2-methylphenoxy)acetic acid" designation is preferred under current conventions for naming chemicals. Accordingly, the tolerance definition listed under 40 CFR § 180.339(a) should be amended to read as follows: Tolerances are established for residues of the herbicide 4-chloro-2-methylphenoxyacetic acid from application of the herbicide in the acid form, in the form of its sodium or dimethylamine salts, or its 2-ethylhexyl ester in or on raw agricultural commodities as follows: Livestock Commodities The current tolerance expression for livestock commodities at 40 CFR § 180.339(b) includes MCPA and its metabolite 2-methyl-4-chlorophenol. Based on limited toxicity data on 2-methyl-4-chlorophenol, a currently regulated livestock metabolite, EPA expects this metabolite to be significantly less toxic than the parent compound. Therefore, 2-methyl-4-chlorophenol can be excluded from the tolerance expression, and only residues of MCPA, per se, will be regulated in livestock commodities. Accordingly, the tolerance definition listed under 40 CFR § 180.339(b) will be amended to read as follows: 64 ------- Tolerances are established for the negligible residues (N) of the herbicide (4-chloro-2- methylphenoxy)acetic acid in or on the following raw agricultural commodities: MCPA Tolerances The MCPA Task Force Three has agreed to voluntarily cancel use of MCPA on rice and grain sorghum. Therefore, the Agency will commence proceedings to propose the revocation of the corresponding tolerances. A summary of the MCPA tolerances is presented in Table 36. A full description of the tolerance reassessment can be found in the Residue Chemistry Chapter for MCPA (dated June 3, 2004, and September 14, 2004). Table 36: Tolerance Summary for MCPA - 40 CFR §180.339(a), (b) Commodity Current Tolerance, ppm Tolerance Reassessent, ppm [0 CFR §180.339(a) - Tolerances are established for residues of the herbicide 4-chloro-2- methylphenoxyacetic acid from application of the herbicide in the acid form, in the form of its sodium or [imethylamine salts, or its 2-ethylhexyl ester in or on raw agricultural commodities as follows: Alfalfa Alfalfa, hay Parley, grain Parley, straw Canarygrass, annual, seed Clover Clover, hay rlax, straw rlaxseed Grass, canary, annual, straw Grass, pasture Grass, rangeland Grass, hay ^espedeza Oat, forage Oat, grain Oat, straw 'eavines 'eavines, hay lice, grain 0.1 0.1 0.1 (N) 2 0.1 0.1 0.1 2 0.1 (N) 0.1 300 300 20 0.1 20 0.1 (N) 2 0.1 (N) 0.1 (N) 0.1 (N) 0.1 0.1 0.1 (N) 2 0.1 0.1 0.1 2 0.1 (N) 0.1 300 300 20 0.1 20 0.1 (N) 2 0.1 (N) 0.1 (N) Revoke 65 ------- Commodity lice, straw lye, grain lye, straw Sorghum, fodder Sorghum, forage Sorghum, grain "refoils "refoil hay Vegetables, seed and pod Vetches Vetch, hay Wheat, grain Wheat, straw Current Tolerance, ppm 2 0.1 (N) 2 20 20 0.1 0.1 0.1 0.1 0.1 0.1 0.1 (N) 2 Tolerance Reassessent, ppm Revoke 0.1 (N) 2 20 20 Revoke 0.1 0.1 0.1 0.1 0.1 0.1 (N) 2 40 CFR §180.339(b) - Tolerances are established for the negligible residues (N) of the herbicide (4- chloro-2-methylphenoxy)acetic acid in or on the following raw agricultural commodities: Cattle, fat Cattle, meat byproducts Cattle, meat Goat, fat Goat, meat byproducts Goat, meat Hog, fat log, meat byproducts log, meat lorse, fat lorse, meat byproducts lorse, meat Milk Sheep, fat Sheep, meat byproducts Sheep, meat 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) 0.1 (N) * Bolded entries indicate revised tolerance. (1) Codex/International Harmonization 66 ------- No Codex MRLs have been established for MCPA; therefore, issues of compatibility between Codex MRLs and U.S. tolerances do not exist. No Canadian or Mexican MRLs have been established for MCPA. We note that registered food uses of MCPA exist in Canada (for crops such as wheat, barley, rye, oats, flax, peas, corn, pasture grass, alfalfa, and trefoil); these uses presumably fall under the PMRA General MRL of 0.1 mg/kg [Regulation B.I 5.002(1) of the Canadian Food and Drugs Regulations (FDR) establishes 0.1 ppm as the "General Maximum Residue Limit." This regulation states that a food is adulterated if it contains residues of a pesticide at a level greater than 0.1 ppm unless a specific MRL has been established in Table n, Division 15 of the FDR] 2. Labels Provided the following risk mitigation measures are incorporated in their entirety into labels for MCPA- containing products, the Agency finds that all currently registered uses of MCPA are eligible for reregistation except rice and grain sorghum, which are uses that the registrants have agreed to voluntarily cancel. The regulatory rationale for each of the mitigation measures outlined below is discussed immediately after this list of mitigation measures. 3. Mitigation for Agricultural Uses The Agency has identified the following mitigation measures that reduce risks to agricultural workers and wildlife to levels the Agency considers reasonable: a. Use Cancellations The MCPA Task Force Three has requested the voluntary cancellation of rice and grain sorghum. The Agency will publish a FIFRA 6(f) cancellation notice in the Federal Register and propose the revocation of the associated tolerances. As a condition of reregistration, end-use products labeled for these uses must be amended to remove these use sites. b. Application Rate Reductions The MCPA Task Force Three has agreed to the following reductions to the maximum label rates for MCPA. As a condition of re-registration, end-use products labeled for these uses will be amended to reflect the new application rates. Table 37: MCPA Use Rate Reductions Site Wheat Old Maximum Rate 1.5 Ib/A New Maximum Rate 0.75 Ib/A Typical Rate 0.375 Ib/A Comments Pre-boot stage. Maximum rate may be divided into two applications. 67 ------- Site Parley Oats Rye 7lax lesidential Turf Sod Farms Golf Courses Grass Grown for Seed 'asture/ rangeland •vfoncropland, lights-of-Way (Broadcast treatment) •vfoncropland, lights-of-Way (Spot treatment) Old Maximum Rate 1.5 Ib/A 1.5 Ib/A 1.5 Ib/A 0.375 Ib/A 2.0 Ib/A 2.0 Ib/A 2.0 Ib/A 2.0 Ib/A 4.0 Ib/A 4.0 Ib/A 4.0 Ib/A New Maximum Rate 0.75 Ib/A 0.75 Ib/A 0.75 Ib/A 0.25 Ib/A 1.5 Ib/A 1.5 Ib/A 1.5 Ib/A 1.5 Ib/A 1.5 Ib/A 1.5 Ib/A 3.0 Ib/A Typical Rate 0.375 Ib/A 0.375 Ib/A 0.375 Ib/A 0.25 Ib/A 1.0 Ib/A 1.0 Ib/A 1.0 Ib/A 1.0 Ib/A 1.25 Ib/A 1.5 Ib/A 2.25 Ib/A Comments Pre-boot stage. Maximum rate may be divided into two applications. Pre-boot stage. Maximum rate may be divided into two applications. Pre-boot stage. Maximum rate may be divided into two applications. IR-4 use Up to 2 applications per year with a minimum retreatment interval of 21 days. Up to 2 applications per year with a minimum retreatment interval of 21 days. Up to 2 applications per year with a minimum retreatment interval of 21 days. Up to 2 applications per year with a minimum retreatment interval of 21 days. Up to 2 applications per year with a minimum retreatment interval of 21 days. Broadcast treatment - Up to 2 applications per year with a minimum retreatment interval of 21 days. Localized hard-to-kill herbaceous plants, brush, or woody plants. D. Regulatory Rationale Following the release of the MCPA risk assessments, a series of meetings were held with the MCPA Task Force Three to discuss ways to reduce residential, occupational, and ecological risks to levels below the Agency's level of concern. In conjunction with those meetings, the task force submitted additional data and information bearing directly on the risks of concern. In particular, the task force submitted new information about typical application rates and how the product is used. Furthermore, the task force submitted a new dermal absorption study. The Agency reviewed the new dermal absorption study, and concluded that the dermal absorption factor for converting dermal exposures to oral equivalent doses should be decreased from thirty percent to seven percent. In July 2004, after the revised MCPA risk assessments were released for 60-day public comment, the Agency conducted a new dose analysis for determining the need for and size of Database Uncertainty 68 ------- Factors to account for the lack of a developmental neurotoxicity (DNT) study. This most recent analysis was based on new scientific information gained from the Agency's review of several recently-submitted DNT studies. The change affected the MCPA residential, dietary, and drinking water health risk assessments. Originally, a 10X Database Uncertainty Factor for the lack of a DNT study was applied for all routes and durations of residential and dietary exposure. Based on the new analysis, the 10X was retained for acute dietary, acute incidental oral, and acute residential dermal exposure scenarios. However, the Database Uncertainty Factor was decreased to 3X for short- and intermediate-term dermal exposures, and was removed (IX) for all other exposure durations and routes. Please see Section IV.C.l.c, above, for additional discussion of the Database Uncertainty Factor. The new application of Database Uncertainty Factors necessitated revisions to the occupational/residential, dietary, and drinking water health risk assessments. Therefore, the following revised documents are being released along with this RED document: • MCPA Revised Human Health Risk Assessment for the Reregistration Eligibility Decision (RED) Document, dated September 14, 2004; Second Revised Occupational and Residential Exposure and Risk Assessment for the Reregistration Eligibility Decision (RED) Document, dated September 7, 2004; • MCPA Revised Product & Residue Chemistry Chapter for the Reregistration Eligibility Decision, dated September 14, 2004; and • Revised MCPA Acute and Chronic Dietary Exposure Assessment for the Reregistration Eligibility Decision, dated September 15, 2004. The following is a summary of the rationale for managing risks associated with the use of MCPA. Where labeling revisions are warranted, specific language is set forth in the summary tables of Section V of this document. 1. Human Health Risk Management a. Dietary (Food) Risk Mitigation Acute and chronic dietary risk from food alone is below the Agency's level of concern. No mitigation is required. b. Drinking Water Risk Mitigation Risk from drinking water is below the Agency's level of concern. No mitigation is required. c. Residential Risk Mitigation (1) Residential Handler Mitigation 69 ------- Residential handler risk from application of MCPA products at the new lower application rates (as presented in Section IV.C.3), calculated using the revised dermal absorption value (as discussed in Section IV.D) and the new Database Uncertainty Factors (as discussed in Section IV.D), resulted in risk estimates that are below the Agency's level of concern (i.e., the dermal MOEs exceed 300 and the inhalation MOEs exceed 100). In addition, the Aggregate Risk Index (ARI) for the combined dermal and inhalation exposures exceeds 1.0, and therefore the combined risks are also not of concern. No additional mitigation is required. See Table 37, below, for a summary of the revised MOEs and ARIs. Table 38: Revised MCPA Short-term MOEs for Homeowner Applications to Lawns Scenario Application Rate = 1.5 Ib ai/acre) land Application of Granules telly Grinder Application ^oad/Apply Granules with a Broadcast Spreader Vlix/Load/Apply with a Hose-end Sprayer (Mix your own) Vlix/Load/Apply with a Hose-end Sprayer (Ready to Use) Vlix/Load/Apply with Hand Held Pump Sprayer Vlix/Load/Apply with Ready to Use Sprayer Treated Area (acres/day) 0.023 0.023 0.5 0.5 0.5 0.023 0.023 Dermal MOE (Target MOE = 300) 1800 1800 14000 850 3600 5300 3800 Inhalation MOE (Target MOE = 100) 19000 140000 4500000 26000 37000 1900000 250000 ARIA 5.8 6.1 46 2.8 12 18 12 4 ARI = l/((300/Dermal MOE) + ( 1 00/Inhalation MOE)) (2) Residential Postapplication Mitigation Using the lower application rates (as presented in Section IV.C.3) and the new dermal absorption value (as discussed in Section IV.D), and applying the new Database Uncertainty Factors (as discussed in Section IV.D), the individual MOEs for acute exposures to both adults and toddlers are below the Agency's level of concern (i.e., MOEs are above 1,000). However, when these individual MOEs are combined across exposure pathways, the MOE for combined toddler acute exposures (from dermal, hand-to-mouth, object-to-mouth, and soil ingestion exposure) is slightly less than 1,000 (MOE=940), and therefore exceeds the EPA's level of concern. See Table 38, below, for a summary of the revised acute MOEs for postapplication turf exposures. Because the MOE for combined toddler acute exposures may be of concern to the Agency, the MCPA Task Force has committed to undertake a study to determine the dermal transfer efficiency of MCPA residues from turf to dry and wetted palms. This hand-press study is intended to confirm that the transfer coefficient used in the toddler exposure assessment is conservative and overestimates risk from mouthing 70 ------- behaviors. The Agency believes that the chemical-specific data in this study will verify that the residue dislodgeable from wet hands is, to some degree, less than the 5% default used in the assessment. This study must be submitted within the 9-month time period allotted to submit revised labels for MCPA. 71 ------- Table 39: Revised Acute MOEs for Turf Exposures* Population Subgroup Toddlers "emales (age 1 3 to 50) \ll Utner Adults Scenario r'laying Yardwork Golfing Yardwork Golfing TTR iUg/cm ) 0.514 0.514 0.514 TC (cni2/hr) 5200 14500 500 14500 500 IMSFlHSll MOB {Target MOE = • y 1,000) 2000 2300 33300 3400 49000 Hund-to Mouth MOI (Target MQE = 1*000) 2200 N/A N/A Object to Mouth MOE (Target MOE = lrOOO) 8900 N/A N/A Soil Ingeition MOE (Target faOE= 1,000) / 670000 N/A N/A Total MOE (Target MOE = 1,000) 940 2300 33300 3400 49000 »Jote: Bolded MOEs indicate that the scenario exceeds the Agency's Level of Concern " Assuming an application rate of 1.5 Ib ae/acre. The revised MOEs for short-term exposures to adults and toddlers exceed the target MOEs, and the Aggregate Risk Index (ARI) for toddlers exceeds 1.0. Therefore, the risks for adults and toddler short- term exposures are not of concern either when considered separately or when combined. No additional mitigation is required. See Table 39, below, for a summary of the revised MOEs and ARIs. Table 40: Revised Short Term MOEs and ARI Values for Turf Exposures" Scenario Dlaying Yardwork Golfing TTM (ugfam2) 0.097 0.081 0.097 0.081 0.097 0.081 TC (cm2/hr) 5200 14500 500 Dermal MOE (T-arg et MOE,= '30ffl) 1500 1800 2500 2900 36000 43000 Hand-to Moi|th MOE (TfrgetMOE=100) 510 720 Object to Mouth MOE(Targ«t MOE = ^ 100) 2000 2900 Soil Ingestlpn MOtf(Target • MOE = iOtfj* 150000 210000 XK^ 2.23 2.91 N/A L ARI = l/((300/Dermal MOE) + (100/Hand-to-Mouth MOE)+ (100/Object-to-Mouth MOE)+(100/Soil Ingestion VIOE)) * Assuming an application rate of 1 .5 ae/acre, exposure body weight 1 5 kg for toddlers. d. Aggregate Risk Mitigation (1) Short-term Aggregate Risk Table 40, below, presents the results of a short-term aggregate exposure assessment that quantifies risk from short-term exposure to food, water, and residential sources. The assessment was conducted with the revised short-term ARI values, which reflect the lower application rates agreed to by the registrants, the new dermal absorption value, and the new Database Uncertainty Factors. 72 ------- Comparison of the short-term DWLOCs with the environmental concentrations of MCPA estimated using PRZM-EXAMS and SCI-GROW modeling indicate that short-term aggregate risks are not of concern. The DWLOCs are less than the surface water EEC of 1.9 ppb and the ground water EEC of 2.13 ug/1, and therefore, the short-term aggregate risks are not of concern. No mitigation is required. Table 41: MCPA Short-term Aggregate Risks (Expressed as DWLOCs) Population Subgroup U.S. Population Children 1-2 yr Body Weight (kg) 70 10 Daily Water Consumption liter/day) 2 1 Food Exposure mg/kg/day) 0.0013 0.0038 Food ARI1 34 12 Turf ARI2'3 8.3 2.2 Available ARI For Water Exposure* 1.2 2.2 Available Water Exposure (mg/kg/day) 0.037 0.020 DWLOC6 (ug/1) 1300 200 Notes 1. Food ARI = cPAD/Food Exposure where the cPAD = 0.044 mg/kg/day 2. Turf ARI for children taken from Table 39, above. ARI = l/((300/Dermal MOE) + (100/Hand-to-Mouth MOE)+ (100/Object-to-Mouth MOE)+(100/Soil Ingestion MOE)) 3. Turf ARI for adults = Dermal MOE/Target MOE, where dermal MOE = 2500 and Target MOE = 300. 4. Available ARI: 1 = l/((l/Food ARI)+(l/Turf ARI) + (1/X)) where X = Available ARI 5. Available Water Exposure = cPAD/Available ARI for Water Exposure 6. DWLOC = (Available Water Exposure X Body Weight)/(Daily Water Consumption X O.OOlmg/ug) (2) Chronic Aggregate Risk No chronic residential scenarios have been identified for MCPA. Therefore, chronic aggregate risks are based solely on dietary exposure from food and water. Conservative exposure estimates for food and drinking water indicate that there is no concern for chronic health risks from these pathways. No mitigation is required. e. Occupational Risk Mitigation (1) Handler Risk Mitigation When assessed at the lower application rates (as presented in Section IV.C.3) and the new dermal absorption value (as discussed in Section IV.D), all of the occupational handler MOEs exceed target MOEs with baseline Personal Protective Equipment (long pants, long sleeved shirt, shoes with socks, and no gloves or respirator) for all scenarios except for the mixing and loading of liquids for aerial, groundboom, and right-of-way sprayer application, and the mixing and loading of wettable powder to groundboom application to golf courses. With the addition of chemical resistant gloves, all scenarios except for mixing/loading liquids for application to rangeland/pastureland do not exceed the Agency's level of concern (MOEs > 100). The MOE for mixing/loading liquids for rangeland/pastureland application does not exceed the Agency's level of concern when assessed with single layer PPE and a filtering facepiece respirator (i.e., dustmask) with a protection factor of five. See Table 41 for a summary of the revised MOEs. 73 ------- Table 42 - Revised Short/Intermediate Term MOEs for Occupational Handlers Exposure Scenario Vlixer/Loader (M/L) Applicator Vlixer/Loader/ Applicator (M/L/A) Dagger Formulation/ Application Method M/L Wettable Powder for Groundboom M/L Liquids for Aerial M/L Liquids for Groundboom M/L Liquids for Row Sprayer Load Granulars for Broadcast Spreader Aerial Application Groundboom Application Right of Way Application Broadcast Spreader Application M/L/A Liquids with Backpack Sprayer M/L/A Wettable Powder with Lurfgun M/L/A Liquid Flowables with Lurfgun Load/Apply Granules with a Push Cyclone Flag Aerial Application Crop or Site Golf Courses Rangeland, Dastures 5mall Grains "lax and Peas Rangeland, Dastures All other Crops Golf Courses Weed Control Brush Control Golf Courses All Crops Above All Crops Above Weed Control Brush Control Golf Courses 5pot Treatment turf turf turf Rangeland, Pasture All other Crops Application Rate 'lb ae/acre) 1.5 1.5 ).75 ).375 1.5 ).375to0.75 1.5 1.5 5.0 1.5 ).375to 1.5 ).375tol.5 1.5 5.0 1.5 5 1.5 1.5 1.5 1.5 ).375to0.75 Acres/ Day 10 1200 1200 1200 >00 >00 10 50 10 10 1200 10 to >00 50 10 10 1 5 5 5 1200 1200 Baselin e 25 1.3 2.7 5.3 8 >16 30 32 80 2500 >590 >760 67 170 3100 ND ND ND ND 210 >410 Single Layer with gloves 110 77 150 310 460 >920 1700 1900 4600 2600 ND >760 190 490 3400 220 430 1700 290 190 >390 Single LayerPFS with gloves 320 140 280 550 320 >1600 3100 3300 3200 3000 SID >1300 230 570 9200 230 910 1800 350 290 >570 \Tote - MOEs in bold font are below the target MOE of 100 and indicate risks of concern. In addition to the required application rate reductions and use cancellations presented in Section IV.C.3, the following mitigation is required to address risks to occupational handlers. 74 ------- Single-layer PPE (long pants, long sleeved shirt, shoes, socks, and chemical resistant gloves) and a PF5 Respirator must be worn when handlers are performing the following tasks: Mixing/Loading Liquids for aerial application to rangeland/pastures Single-layer PPE (long pants, long sleeved shirt, shoes, socks, and chemical resistant gloves) must be worn when handlers are performing the following tasks: Mixing/Loading wettable powders for groundboom application Mixing/Loading liquids for aerial application to small grains, flax, and peas Mixing/Loading liquids for groundboom application Mixing/Loading liquids using row sprayer Mixing/Loading/Applying liquids with backpack sprayer Mixing/Loading/Applying wettable powders with turfgun Mixing/Loading/Applying liquids flowables with turfgun Loading/Applying granules with a push cyclone Applying to rights-of-way for weed control • Baseline PPE (long pants, long sleeved shirt, shoes, and socks) must be worn by handlers during the following activities: Applying aerially, or by groundboom or broadcast spreader Flagging aerial spray applications (2) Post-application Risk Mitigation When assessed at the lower application rates (as presented previously in Section IV.C.3), all of the short/intermediate term MOEs for post-application occupational exposure to MCPA exceed the target MOE, which indicates that the risks are not of concern. Chronic post-application occupational exposure was not evaluated because MCPA is typically applied once per season, and thus chronic exposure is not expected. See Table 42 for a summary of the MOEs. Table 43: MCPA Postapplication Worker Risks Crop •lax 3eas imall Grains Turf Transfer Coefficient Group Field/row crop, low/medium Field/row crop, low/medium Field/row crop, low/medium Turf - California Short/Intermediate Term MOE on Day 0 Application Rate (Ib ae/acre) 0.375 0.375 0.75 1.5 Low Exposure Scenarios 10000 10000 5200 960 Medium Exposure Scenarios 690 NA 340 NA High Exposure Scenarios NA NA NA 480 75 ------- Table 43: MCPA Postapplication Worker Risks Crop Transfer Coefficient Group Turf - North Carolina Short/Intermediate Term MOE on Day 0 Application Rate (Ib ae/acre) 1.5 Low Exposure Scenarios 500 Medium Exposure Scenarios NA High Exposure Scenarios 250 The Restricted Entry Interval (REI) represents the amount of time required for residues to dissipate in treated areas prior to beginning a job or task in that area such that the resulting exposures do not exceed the Agency's level of risk concern. In order to determine the REI for a crop, EPA calculates the number of days that must elapse after pesticide application until residues dissipate and risk to a worker falls below the target risk level. For a specific crop/pesticide combination, the duration required to achieve the target risk estimate can vary depending on the activity assessed. The current REIs are 12 hours for the ester form and 48 hours for the amine and sodium salt forms. The current REIs are sufficiently protective, and thus no modification is required. There is no REI for the acid form because the acid form is used only on non-agricultural sites (such as lawns and golf courses). 2. Environmental Risk Mitigation Implementation of the mitigation measures described above - the rate reductions and use cancellations presented in Section IV.C.3 - has resulted in decreases in exposure values, leading to significantly lower RQ's for terrestrial and aquatic organisms, as well as terrestrial and aquatic plants. There are a few scenarios which still show LOG exceedances at the lower application rates, particularly terrestrial plants. However, most of these exceedances are slight and, therefore, EPA has determined that no further risk mitigation is necessary for environmental concerns. An additional mitigation measure that was agreed to by registrants and which will be required on applicable end-use products is a statement limiting spray droplet size to "medium to coarse," thereby prohibiting "fine" sprays. This mitigation measure should provide additional protection to wildlife and plants. 3. Other Labeling Requirements In order to be eligible for reregistration, various use and safety information must also be placed on the labeling of all end-use products containing MCPA. For the specific labeling statements, refer to Section V of this document. a. Endangered Species Statement The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation 76 ------- measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses that may affect any particular species, EPA uses basic toxicity and exposure data and considers ecological parameters, pesticide use information, geographic relationship between specific pesticide uses and species locations, and biological requirements and behavioral aspects of the particular species. Based on EPA's screening level assessment for MCPA, RQs exceed levels of concern for mammals, birds, aquatic plants, and terrestrial plants. However, these findings are based soley on EPA's screening level assessment and do not constitute "may affect" findings under the ESA. The Agency is requiring application rate reductions and additional mitigation to minimize these LOG exceedances, and is requiring additional data to further characterize and refine its ecological and endangered species risk assessments. b. Spray Drift Management The Agency is in the process of developing more appropriate label statements for spray and dust drift control to ensure that public health, and the environment is protected from unreasonable adverse effects. The Agency will publish final guidance in a Pesticide Registration notice for registrants to use when labeling their products. V. What Registrants Need to Do The Agency has determined that MCPA is eligible for reregistration provided that: (i) additional data that the Agency intends to require confirm this interim decision; and (ii) the risk mitigation measures outlined in this document are adopted, and label amendments are made to reflect these measures. To implement the risk mitigation measures, the registrants must amend their product labeling to incorporate the label statements set forth in the Label Summary Table in Section V.D (Table 43). The additional data requirements that the Agency intends to obtain will include, among other things, submission of the following: A. For MCPA technical grade active ingredient products, registrants need to submit the following items. Within 90 days from receipt of the generic data call-in (DCI): (1) completed response forms to the generic DCI (i.e., DCI response form and requirements status and registrant's response form); and (2) submit any time extension and/or waiver requests with a full written justification. 77 ------- Within the time limit specified in the generic DCI: (1) cite any existing generic data which address data requirements or submit new generic data responding to the DCI. Please contact Kelly White at (703) 305-8401 with questions regarding generic reregistration and/or the DCI. All materials submitted in response to the generic DCI should be addressed as follows: Bv US mail: Document Processing Desk (DCI/SRRD) Kelly White US EPA (7508C) 1200 Pennsylvania Ave., NW Washington, DC 20460 By express or courier service: Document Processing Desk (DCI/SRRD) Kelly White Office of Pesticide Programs (7508C) Room 266A, Crystal Mall 2 1801 Bell Street Arlington, VA 22202 B. For products containing the active ingredient MCPA. registrants need to submit the following items for each product. Within 90 days from the receipt of the product-specific data call-in (PDCI): (1) completed response forms to the PDCI (i.e., PDCI response form and requirements status and registrant's response form); and (2) submit any time extension or waiver requests with a full written justification. Within eight months from the receipt of the PDCI: (1) two copies of the confidential statement of formula (EPA Form 8570-4); (2) a completed original application for reregistration (EPA Form 8570-1). Indicate on the form that it is an "application for reregistration"; (3) five copies of the draft label incorporating all label amendments outlined in Table 43 of this document; (4) a completed for certifying compliance with data compensation requirements (EPA Form 8570-34); (5) if applicable, a completed for certifying compliance with cost share offer requirements (EPA Form 8570-32); and (6) the product-specific data responding to the PDCI. 78 ------- Please contact Bonnie Adler at (703) 308-8523 with questions regarding product reregistration and/or the PDCI. All materials submitted in response to the PDCI should be addressed as follows: Bv US mail: Document Processing Desk (PDCI/PRB) Bonnie Adler US EPA (7508C) 1200 Pennsylvania Ave., NW Washington, DC 20460 By express or courier service: Document Processing Desk (PDCI/PRB) Bonnie Adler Office of Pesticide Programs (7508C) Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 79 ------- A. Manufacturing Use Products 1. Additional Data Requirements The generic database supporting the reregistration of MCPA has been reviewed and determined to be substantially complete. However the following data requirements are necessary to confirm the reregistration eligibility decision in this RED. Toxicology: • 870.6300 Developmental neurotoxicity study in rats with MPCA EHE 870.3465 Twenty eight (28) day inhalation study in rats (abbreviated 90-day protocol). The Agency is requiring this study due to the concern for the potential occupational exposure via this route based on the current use pattern. The registrant is recommended to follow all the procedures stipulated in the Subdivision F Guidelines for the 90-day inhalation study (870.3465) except that the exposure duration can be reduced to 28 days Environmental Fate: 835.1410 Laboratory volatility study with MCPA EHE • 835.4100 Laboratory fate data for aerobic soil metabolism for MCPA EHE, preferably under acid conditions • 835.1240 Laboratory fate data for a batch equilibrium study conducted with MCPA EHE, preferably under a range of pHs Ecological Effects: 850.4225 Seedling Emergence (Tier E) for three formulations of MCPA: (1) either the acid or sodium salt, (2) DMAS, and (3) EHE, all using a TEP 850.4250 Vegetative Vigor (Tier H) for three formulations of MCPA: (1) either the acid or sodium salt, (2) DMAS, and (3) EHE, all using a TEP • 850.4400 Aquatic Plant Growth (Tier n with Lemna sp.) using three formulations of MCPA: (1) either the acid or sodium salt, (2) DMAS, and (3) EHE, all using a TEP 80 ------- 850.2200 Avian Dietary LC50 Guideline for one species (preferably bobwhite quail) using MCPAEHE. Residue Chemistry: • 860.1300 Metabolism studies on peas • 860.1340 Residue analytical method: The Residue Chemistry Chapter of the Registration Standard dated 8/31/81 noted that the PAM Vol I method is adequate for enforcement of tolerances for residues of MCPA in livestock commodities as-is, however the Agency is now requiring the method be modified with a hydrolysis step for enforcement of MCPA tolerances for plant commodities. 860.1380 Storage stability data for wheat grain stored under ambient conditions for 28 days 860.1480 Ruminant feed study • 860.1500 Four field trials reflecting a 0-day PHI for pasture forage 860.1900 A study detailing confined accumulation in rotational crops planted following treatment at 1.5 Ib ae/A Occupational/Residential Exposure: 875.1100 Hand press study 2. Labeling for Manufacturing Use Products To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies. The MP labeling should bear the labeling contained in Table 43 at the end of this section. B. End-Use Products 1. Additional Product-Specific Data Requirements Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. Registrants must review previous data submissions to ensure that they meet current EPA acceptance criteria, and if not, commit to conduct new 81 ------- studies. If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product. A product-specific data call-in, outlining specific data requirements, accompanies this RED. 2. Labeling for End-Use Products Labeling changes are necessary to implement the mitigation measures outlined in Section IV above. Specific language to incorporate these changes is specified in Table 44. C. Labeling Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended. 82 ------- Table 44: Labeling Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended. Table 44: Summary of Labeling Changes for MCPA on Lubel For all Manufacturing Use Products "Only for formulation into an herbicide for the following use(s) [fill blank only with those uses that are being supported by MP registrant]." "Uses for rice and grain sorghum are canceled. Technical and end-use product labels must be revised to delete all references to and use-directions for these canceled use patterns." Directions for Use One of these statements may be added to a label to allow reformulation of the product for a specific use or all additional uses supported by a formulator or user group "This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)." "This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)." Directions for Use Environmental Hazards Statements Required by the RED and Agency Label Policies "Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA." Precautionary Statements 83 ------- ,4 ,tTse Products |nteij46d/'f°r Occupational Use ',/' •••" x ^/ / .v ^ '•'.-•' .- x * ,/>••- PPE Requirements Established by the RED1 for Liquid Concentrate Formulations "Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant material). "If you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection chart." "Personal Protective Equipment (PPE)" "Mixers, loaders, applicators, flaggers and other handlers must wear: - Long- sleeved shirt and long pants, - Shoes plus socks, and - Chemical- resistant gloves when mixing, loading, or using any hand-held equipment." Immediately following/below Precautionary Statements: Hazards to Humans and Domestic Animals Additional PPE Requirements Established by the RED for Liquid Concentrate Formulations that contain directions for use for aerial application to rangeland, or pasture land, or noncropland "Additional PPE requirements for mixers and loaders supporting aerial application to rangelands, pasture lands, or noncropland. These mixers/loaders also must wear: - a chemical-resistant apron, and - a NIOSH-approved respirator with a dust/ mist filter with MSHA/ NIOSH approval number prefix TC-21C or any N2, R, P, or HE filter." "See engineering controls for additional requirements." Immediately following the handler PPE statement specified for liquid concentrate formulations PPE Requirements Established by the RED1 for Water Dispersable Granules and for Wettable Powder Formulations (including Wettable Powders formulated in water soluble packages.) "Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-resistant material). "If you want more options, follow the instructions for category" [registrant inserts A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection chart." "Personal Protective Equipment (PPE) Mixers, loaders, applicators, and other handlers must wear: - Long- sleeved shirt and long pants, - Shoes plus socks, and - Chemical-resistant gloves when mixing, loading, or using hand-held equipment." Immediately following^elow Precautionary Statements: Hazards to Humans and Domestic Animals 84 ------- PPE Requirements Established by the RED1 for Granular Formulations "Personal Protective Equipment (PPE) Loaders, applicators, and other handlers must wear: - Long- sleeved shirt and long pants, and - Shoes plus socks." Immediately following^elow Precautionary Statements: Hazards to Humans and Domestic Animals User Safety Requirements "Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry." Precautionary Statements: Hazards to Humans and Domestic Animals immediately following the PPE requirements Engineering Controls for aerial applications Enclosed Cockpits "Engineering Controls: Pilots must use an enclosed cockpit that meets the requirements listed in the WPS for agricultural pesticides [40 CFR 170.240(d)(6)]." Precautionary Statements: Hazards to Humans and Domestic Animals immediately following PPE and User Safety Requirements. 85 ------- User Safety Recommendations "User Safety Recommendations Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing." Precautionary Statements under: Hazards to Humans and Domestic Animals immediately following Engineering Controls or if no Engineering Controls statements, immediately following User Safety Requirements (Must be placed in a box.) Environmental Hazards "This pesticide may be toxic to fish, aquatic invertebrates and aquatic plants. Do not apply directly to water, to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours." "This chemical has properties and characteristics associated with chemicals detected in groundwater. The use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in groundwater contamination." Precautionary Statements immediately following the User Safety Recommendations Restricted-Entry Interval for MCPA products that contain acid, amine, or sodium salt forms and have directions for use within the scope of the WPS "Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 48 hours." Directions for Use, Under Agricultural Use Requirements Box 86 ------- Restricted-Entry Interval for MCPA products that contain only ester forms and have directions for use within the scope of the WPS "Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12 hours." Directions for Use, Under Agricultural Use Requirements Box Early Entry Personal Protective Equipment for MCPA products that contain acid, amine, or sodium salt forms and have directions for use within the scope of the WPS "PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, is: * coveralls, * shoes plus socks, * chemical-resistant gloves made of any waterproof material, and * protective eyewear." Direction for Use Agricultural Use Requirements box immediately following the REI statement Early Entry Personal Protective Equipment for MCPA products that contain only ester forms and have directions for use within the scope of the WPS "PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water is: * coveralls, * shoes plus socks, and * chemical-resistant gloves made of any waterproof material." Direction for Use Agricultural Use Requirements box immediately following the REI statement General Application Restrictions for products primarily intended for occupational (professional) use "Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application." Place in the Directions for Use directly above the Agricultural Use Box if there is one, otherwise place in Directions for Use under General Precautions and Restrictions 87 ------- Use-Specific Application Restrictions (Note: The maximum allowable application rate must be listed as pounds or gallons of formulated product per acre not just as pounds active equivalent per acre.) Wheat Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 0.75 Ib ae / acre per year (registrant state this in amount of formulation per acre per year)." Barley Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 0.75 Ib ae / acre per year (registrant state this in amount of formulation per acre per year)." Oats Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 0.75 Ib ae / acre per year (registrant state this in amount of formulation per acre per year)." Rye Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 0.75 Ib ae / acre per year (registrant state this in amount of formulation per acre per year)." Flax Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 0.25 Ib ae / acre per year (registrant state this in amount of formulation per acre per year)." Directions for Use Associated with the Specific Use Pattern ------- Other Application Restrictions (Note: The maximum allowable application rate and maximum allowable rate per year must be listed as pounds or gallons of formulated product per acre, not just as pounds active equivalent per acre.) Sod farms Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Golf Courses Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Grass Grown for Seed Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Directions for Use Associated with the Specific Use Pattern 89 ------- Other Application Restrictions (Note: The maximum allowable application rate and maximum allowable rate per year must be listed as pounds or gallons of formulated product per acre, not just as pounds active equivalent per acre.) Pasture/ Rangeland Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Noncropland Rights-of-Way (Broadcast Treatment) Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Noncropland Rights-of-Way (Spot Treatment) Permitted forms of MCPA include acid, salts, amines, and esters "Do not apply more than 3.0 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Directions for Use Associated with the Specific Use Pattern Use Deletions -Rice Delete all references to applications to rice from all MCPA end-use labels. - Grain sorghum Delete all references to applications to grain sorghum from all MCPA end-use labels. 90 ------- Spray Drift "SPRAY DRIFT MANAGEMENT" "Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of many equipment-and-weather-related factors determine the potential for spray drift. The applicator and the grower are responsible for considering all these factors when making decisions." "Apply only as a medium or coarser spray (ASAE standard 572) or a volume mean diameter of 300 microns or greater for spinning atomizer nozzles." "Apply only when the wind speed is 2-10 mph at the application site." Additional requirements for aerial applications: "The boom length must not exceed 75% of the wingspan or 90% or the rotor blade diameter." "Release spray at the lowest height consistent with efficacy and flight safety. Do not release spray at a height greater than 10 feet above the crop canopy." "When applications are made with a crosswind, the swath will be displaced downwind. The applicator must compensate for this displacement at the downwind edge of the application area by adjusting the path of the aircraft upwind." "Do not make applications into temperature inversions." Additional requirements for ground boom application: "Do not apply with a nozzle height greater than 4 feet above the crop canopy." Directions for Use 91 ------- End U Application Restrictions "Do not apply this product in a way that will contact any person, or pet, either directly or through drift. Keep people and pets out of the area during application." Directions for Use under General Precautions and Restrictions Other Application Restrictions (Note: The maximum allowable application rate must be listed as pounds or gallons of formulated product per acre not just as pounds active ingredient per acre.) Residential Turf "Do not apply more than 1.5 Ib ae / acre per year (registrant state this in amount of formulation per acre per year). Do not apply more than 2 applications per year with a minimum retreatment interval of 21 days." Entry Restrictions Liquid Concentrate, Wettable Powder, and Water Dispersible Granule (Dry Flowable) formulations "Do not allow people or pets to enter the treated area until sprays have dried." Directions for use under General Precautions and Restrictions Entry Restrictions for Granular Formulations "Do not allow people or pets to enter the treated area until dusts have settled." [If watering in is required after the application, "do not enter or allow others to enter the treated areas (except those involved in the watering) until the watering-in is complete and the surface is dry."] Directions for use under General Precautions and Restrictions 92 ------- Environmental Hazard Statement "This pesticide may be toxic to fish, aquatic invertebrates, and aquatic plants. Do not apply directly to water. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 48 hours. Do not contaminate water when disposing of equipment washwaters or rinsate." Directions for Use Associated with the Specific Use Pattern 1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7. 2 If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped. 93 ------- Appendix A. Use Patterns Subject to Reregistration For MCPA (Case 0017) Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Food/ Feed Uses Maximum # Applications per Year Maximum Yearly Rate Use Directions and Limitations ALFALFA Sodium Salt Spray Aircraft/ Ground Dormant 0.5 Ib Dimethylamine Salt Spray Aircraft/Ground/Sprayer Spray Aircraft/Ground Spray Aircraft/Ground/Sprayer Spray Aircraft/Ground Spray Ground Dormant Foliar Late fall Late Tillering Tillering 0.5 Ib 0.23125 Ib 0.5 Ib 0.25 Ib 0.23125 Ib None 2 1.0 Ib 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (animals being finished for slaughtei 2 2 1 2 2 1.0 Ib .4625 Ib 0.5 Ib 0.5 Ib .4625 Ib 94 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate BARLEY Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Broadcast Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Spot Treatment/Spray Aircraft/Low pressure ground sprayer Early boot Early Jointing Postemergence Tillering 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 l.Slb l.Slb l.Slb l.Slb ). *)• 95 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Dimethylamine salt Spray Aircraft/Ground Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Spray Aircraft/Ground Low volume spray (concentrate) Aircraft/Low volume ground sprayer Spray Aircraft/Ground Early boot Foliar Internode elongation Postemergence Spring Tiller through boot 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib 0.25 Ib 0.75 Ib Maximum it Applications per Year Maximum Yearly Rate 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) prefeeding interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 1 2 l.Slb l.Slb l.Slb l.Slb 0.25 Ib 3.0 Ib 96 ------- Site Application Type Application Equipment Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer ApplicationTiming Tillering Max. Single Application Rate (AE)A 0.75 Ib tsooctyl ester Chemigation/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Sprinkler irrigation Low volume spray (concentrate)/Spray Aircraft/Boom sprayer Low volume spray (concentrate)/Spray Aircraft/Boom sprayer Internode elongation Postharvest Tillering 0.5 Ib 0.5 Ib 0.5 Ib Maximum it Applications per Year 2 Maximum Yearly Rate 3.0 Ib 45 day(s) pregrazing interval. Buffer zone restriction. 2 2 2 1.0 Ib 1.0 Ib 1.0 Ib 97 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate 2-Ethylhexyl ester 7 day(s) preforage interval (animals being finished for slaughter" 14 day(s) preforage interval ( animals being finished for slaughte r). 14 day(s) preforage interval (dairy animals). 14 day(s) pregrazing interval ( dairy animals). 14 day(s) preharvest interval (dry hay). 40 day(s) preharvest interval (grain). 45 day(s) pregrazing interval. 57 day(s) preharvest interval. 7 day(s) prefeeding interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) preharvest interval (forage). Low volume spray (concentrate)/Spray Aircraft/Ground Early spring 0.75 Ib 1 1.38751b Low volume spray (concentrate)/Spray Aircraft/Ground Fall 0.4625 Ib 0.4625 Ib Broadcast/Chemigation/Low volume spray (concentrate)/Spo1 treatment/Spray Aircraft/Backpack sprayer/Boom sprayer/Ground/Hand held prayer/Low pressure ground sprayer/Low volume ground sprayer/Sprinkler irrigation Postemersence 0.75 Ib 3.0 Ib 98 ------- Site Application Type Application Equipment Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Low volume ground sprayer Geographic allowable: MN MT ND SD Low volume spray (concentrate)/Spot treatment Aircraft/Hand held sprayer/Low volume ground sprayer Low volume spray (concentrate)/Spray Aircraft/Ground Low volume ground sprayer ApplicationTiming Postharvest Spring Tillering Max. Single Application Rate (AE)A 0.5 Ib 0.6844 Ib 0.4875 Ib Maximum it Applications per Year 2 1 2 Maximum Yearly Rate 1.0 Ib 0.6844 Ib 0.975 Ib BARLEY-LEGUME MIXTURE Sodium Salt Broadcast/Low volume spray (concentrate) Aircraft/Low pressure ground sprayer Spray Aircraft Early jointing Tillering 0.5 Ib 0.25 Ib 7 days(s) preforage interval (animals being finished for slaughte 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 1.0 Ib 0.5 Ib ). *)• 99 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Dimethylamine salt Spray Aircraft/Ground/Low pressure Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer/Sprayer Internode elongation Late tillering Tillering 0.24585 Ib 0.25 Ib 0.75 Ib Maximum it Applications per Year Maximum Yearly Rate 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 0.4917 Ib 0.5 Ib l.Slb CLOVER Sodium Salt Spray Aircraft/Ground Dormant 0.5 Ib Dimethylamine salt 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 1.0 Ib 100 ------- Site Application Type Application Equipment Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Spray Ground Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Spray Ground ApplicationTiming Dormant Fall Foliar Late fall Late tillering Postemergence Spring Tillering Max. Single Application Rate (AE)A 0.5 Ib 0.4625 Ib 0.23125 Ib 0.4625 Ib 0.25 Ib 0.4625 Ib 0.4625 Ib 0.23125 Ib Maximum it Applications per Year 2 1 2 1 2 2 1 2 Maximum Yearly Rate 1.0 Ib 0.4625 Ib 0.4625 Ib 0.4625 Ib 0.5 Ib 0.925 Ib 0.4625 Ib 0.4625 Ib FLAX 101 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Sodium Salt Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Before bud Break Postemergence 0.25 Ib 0.25 Ib Dimethylamine Salt Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Before bud break Boot Foliar 0.25 Ib 0.25 Ib 0.25 Ib Maximum it Applications per Year Maximum Yearly Rate 7 day(s) preforage interval (animals being finished for slaughter 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 0.50 Ib 0.50 Ib 7 day(s) prefeeding interval on threshings or stubble to meat am 7 day(s) prefeeding interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 0.50 Ib 0.50 Ib 0.50 Ib nals 102 ------- Site Application Type Application Equipment High volume spray (dilute )/Low volume spray (concentrate)/S Aircraft/Ground ApplicationTiming )rayPostemergence Max. Single Application Rate (AE)A 0.25 Ib tsooctyl ester Chemigation/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Sprinkler irrigation Foliar 0.225 Ib 2-Ethylhexyl ester Low volume spray (concentrate)/Spray Aircraft/Ground Broadcast/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Ground Low volume ground sprayer Foliar Postemergence 0.25 Ib 0.25 Ib Maximum it Applications per Year 2 Maximum Yearly Rate 0.50 Ib Buffer zone restriction. 2 0.45 Ib 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) pregrazing interval. 2 2 0.50 Ib 0.50 Ib GRASS FORAGE/FODDER/HAY Sodium Salt Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Early jointing 0.93 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 2 1.861b 103 ------- Site Application Type Application Equipment Spray Aircraft/Ground ApplicationTiming Postemergence Max. Single Application Rate (AE)A 0.93 Ib 2-Ethylhexyl ester Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground Established plantings Fall Spring l.Slb 1.38751b 1.38751b Maximum it Applications per Year 2 Maximum Yearly Rate 1.861b 1 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval (meat animals being finished for slaughter). 1 1 1 3.0 Ib 1.38751b 1.38751b GRASS GROWN FOR SEED Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Spring 1.0 Ib Dimethylamine Salt 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 1 7 day(s) preslaughter interval. 1.0 Ib 104 ------- Site Application Type Application Equipment Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground ApplicationTiming Established plantings Spring Tillering Max. Single Application Rate (AE)A 2.0 Ib 0.8775 Ib 0.8775 Ib 2-Ethylhexyl ester Spray Aircraft/Ground Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Sprayer Established plantings Fall Spring 0.925 Ib 0.925 Ib 0.925 Ib Maximum it Applications per Year 2 1 2 Maximum Yearly Rate 4.0 Ib 0.8775 Ib 1.7551b 7 day(s) prefeeding interval. 7 day(s) pregrazing interval. 2 1 1 1.851b 0.925 Ib 0.925 Ib LESPEDEZA Dimethylamine Salt 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 105 ------- Site Application Type Application Equipment Spray Ground ApplicationTiming Tillering Max. Single Application Rate (AE)A 0.23125 Ib Maximum it Applications per Year 2 Maximum Yearly Rate 0.4625 Ib OATS Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Broadcast Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Early boot Early jointing Postemergence Tiller through boot 0.75 Ib 0.75 Ib 0.75 Ib 0.6975 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 l.Slb l.Slb l.Slb 1.3951b ). *)• 106 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Dimethylamine Salt Spray Aircraft/Ground Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Spray Aircraft/Ground Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer Early boot Foliar Internode elongation Postemergence Tiller through boot Tillering 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib Maximum it Applications per Year Maximum Yearly Rate 14 day(s) preforage interval (animals being finished for slaughte: 14 day(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 2 2 l.Slb l.Slb l.Slb l.Slb l.Slb l.Slb 107 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Isooctyl ester Chemigation/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Sprinkler irrigation Low volume spray (concentrate)/Spray Aircraft/Boom Sprayer Rotational/plant back crop restriction. Geographic allowable: MT ND SD Low volume spray (concentrate)/Spray Aircraft/Boom sprayer Internode elongation Postharvest vTN Tillering 0.5 Ib 0.5 Ib 0.5 Ib Maximum # Applications per Year Maximum Yearly Rate 45 day(s) pregrazing interval. Buffer zone restriction. 2 2 2 1.0 Ib 1.0 Ib 1.0 Ib 108 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate 2-Ethylhexyl ester 7 day(s) preforage interval (animals being finished for slaughter" 14 day(s) preforage interval (animals being finished for slaughte: 14 day(s) preforage interval (dairy animals). 14 day(s) pregrazing interval (dairy animals). 14 day(s) preharvest interval (dry hay ). 40 day(s) preharvest interval (grain)l 45 day(s) pregrazing interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval ( meat animals being finished for slaughter). 7 day(s) pregrazing interval. 7 day(s) preharvest interval (forage). Broadcast/Chemigation/Low volume spray (concentrate)/Spo1 treatment/Spray Aircraft/Backpack sprayer/Boom sprayer/Ground/Hand held prayer/Low pressure ground sprayer/ Low volume ground sprayer/Sprinkler irrigation Postemereence 0.75 Ib l.Slb Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Low volume ground sprayer Geographic allowable: MN, MT, ND, SD Postharvest 0.5 Ib 1.0 Ib 109 ------- Site Application Type Application Equipment Low volume spray (concentrate )/Spray treatment Aircraft/Hand held sprayer/Low volume ground sprayer Low volume spray (concentrate )/Spray Aircraft/Ground ApplicationTiming Spring Tillering Max. Single Application Rate (AE)A 0.6844 Ib (L) Maximum # Applications per Year 1 2 Maximum Yearly Rate 0.6844 Ib OATS-LEGUME MIXTURE Sodium Salt Broadcast/Low volume spray (concentrate) Aircraft/Low pressure ground sprayer Spray Aircraft Early jointing Tillering 0.50 Ib 0.25 Ib Dimethylamine salt Spray Low pressure Internode elongation 0.24585 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 1.0 Ib 0.50 Ib 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 0.4917 Ib ). *)• 110 ------- Site Application Type Application Equipment Spray Aircraft/Ground Low volume spray (conentrate)/Spray Aircraft/Ground/Low pressure/Low pressure ground sprayer/Sprayer ApplicationTiming Late tillering Tillering Max. Single Application Rate (AE)A 0.25 Ib 0.5 Ib Maximum it Applications per Year 2 2 Maximum Yearly Rate 0.50 Ib 1.0 Ib PASTURES Sodium Salt Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Broadcast/Spray Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Broadcast/Spray Aircraft/Ground/Low pressure ground sprayer Established plantings Fall Postemergence Spring 1.3951b l.Slb 1.3951b l.Slb 7 days(s) preforage interval (animals being finished for slaughte 7 days(s) pregrazing interval (meat animals being finished for slaughter). 2 1 2 1 2.79 Ib l.Slb 2.79 Ib l.Slb 111 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Dimethylamine Salt Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Broadcast/Spot treatment/Spray Aircraft/Ground Spray Aircraft/Ground Delayed dormant through bloom Established plantings Fall Foliar Postemergence Spring l.Slb l.Slb l.Slb l.Slb l.Slb l.Slb Maximum it Applications per Year Maximum Yearly Rate 21 day(s) preharvest interval (dry hay). 21 day(s) preharvest interval (forage). 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 1 2 2 1 3.0 Ib 3.0 Ib l.Slb 3.0 Ib 3.0 Ib l.Slb 112 ------- Site Application Type Application Equipment Broadcast/Spot treatment/Spray Aircraft/Ground/High volume ground sprayer/Sprayer ApplicationTiming When needed Max. Single Application Rate (AE)A l.Slb 2- Ethylhexyl ester Spot treatment/Spray Aircraft/Ground Broadcast/Low volume spray (concentrate)/ Spray Aircraft/Ground Broadcast/Low volume spray (concentrate)/Spray Aircraft/Ground Low volume spray (concentrate)/ Spot Treatment Aircraft/Hand held sprayer/Low volume ground sprayer Established plantings Fall Spring When needed l.Slb l.Slb l.Slb l.Slb Maximum it Applications per Year 2 Maximum Yearly Rate 3.0 Ib 1 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval ( meat animals being finished for slaughter). 7 day(s) pregrazing interval. 7 day(s) prefeeding interval. 2 1 1 2 3.0 Ib l.Slb l.Slb 3.0 Ib PEAS (UNSPECIFIED) Sodium Salt 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) pregrazing interval (meat animals being finished for slaughter). Geographic allowable: ID or Pacific NW States (Label verbatim) 113 ------- Site Application Type Application Equipment Broadcast/Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground ApplicationTiming Postemergence Prebloom Max. Single Application Rate (AE)A 0.375 Ib 0.375 Ib Dimethylamine Salt Spray Aircraft/Ground High volume spray (dilute )/Low volume spray (concentrate)/! Aircraft/Ground Spray Aircraft/Ground Spray Aircraft/Ground Foliar prafostemergence Prebloom Tillering 0.375 Ib 0.375 Ib 0.3469 Ib 0.25 Ib 2-Ethylhexyl ester Maximum # Applications per Year 2 2 Maximum Yearly Rate 0.75 Ib 0.75 Ib 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 0.75 Ib 0.75 Ib 0.6938 Ib 0.50 Ib Do not allow the feeding or grazing of foliage by livestock. Geographic allowable: Pacific NW States (Label verbatim). 114 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate Spray Aircraft/Ground Postemereence 0.375 Ib 0.75 Ib RANGELAND Sodium Salt 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Established plantings 1.3951b 2.79 Ib Broadcast/Spray Aircraft/Ground/Low pressure ground sprayer Fall l.Slb l.Slb Spray Aircraft/Ground Postemersence 1.3951b 2.79 Ib Broadcast Spray Aircraft/Ground/Low pressure ground sprayer Spring l.Slb l.Slb Dimethylamine Salt 21 day(s) preharvest interval (dry hay). 21 day(s) preharvest interval (forage). 7 day(s) preforage interval (animals being finished for slaughter 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) preslaughter interval. 115 ------- Site Application Type Application Equipment Spray Aircraft/Ground Spray Aircraft/Ground/Sprayer Spray Aircraft/Ground Broadcast/Spot treatment/Spray Aircraft/Ground Spray Aircraft/Ground/Sprayer Broadcast/Spot treatment/Spray Aircraft/Ground/High volume ground sprayer/Sprayer ApplicationTiming Delayed dormant through bloom Fall Foliar Postemergence Spring When needed Max. Single Application Rate (AE)A l.Slb l.Slb l.Slb l.Slb l.Slb l.Slb 2-Ethylhexyl ester Maximum it Applications per Year 2 I 2 2 I 2 Maximum Yearly Rate 3.0 Ib l.Slb 3.0 Ib 3.0 Ib l.Slb 3.0 Ib 1 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval ( meat animals being finished for slaughter). 7 day(s) pregrazing interval. 7 day(s) prefeeding interval.. 116 ------- Site Application Type Application Equipment Spot treatment/Spray Aircraft/Ground Broadcast/Low volume spray (concentrate)/Spray Aircraft/Ground Broadcast/Low volume spray (concentrate)/Spray Aircraft/Ground Low volume spray (concentrate)/ Spot treatment Aircraft/Hand held sprayer/Low volume ground sprayer ApplicationTiming Established plantings Fall Spring When Needed Max. Single Application Rate (AE)A l.Slb l.Slb l.Slb l.Slb Maximum it Applications per Year 2 1 1 2 Maximum Yearly Rate 3.0 Ib l.Slb l.Slb 3.0 Ib RYE Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Broadcast Aircraft/Ground/Low pressure ground sprayer Early boot Early jointing 0.75 Ib 0.75 Ib 7 days(s) preforage interval (animals being finished for slaughte 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 l.Slb l.Slb 117 ------- Site Application Type Application Equipment Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer ApplicationTiming Postemergence Tiller through boot Max. Single Application Rate (AE)A 0.75 Ib 0.6975 Ib Dimethylamine Salt Spray Aircraft/Ground Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Low pressure ground sprayer Spray Aircraft/Ground Early boot Foliar Internode elongation Postemergence 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib Maximum it Applications per Year 2 2 Maximum Yearly Rate l.Slb 1.3951b 14 day(s) preforage interval (animals being finished for slaughte: 14 day(s) pregrazing interval (dairy animals). 7 day(s) prefeeding interval. 7 day(s) preslaughter interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 2 l.Slb l.Slb l.Slb l.Slb 118 ------- Site Application Type Application Equipment High volume spray (dilute )/Low volume spray (concentrate) Aircraft/Ground/Low volume ground sprayer Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer ApplicationTiming Spring Tiller through boot Tillering Max. Single Application Rate (AE)A 0.25 Ib 0.75 Ib 0.75 Ib tsooctyl ester Chemigation/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Sprinkler irrigation Low volume spray (concentrate )/Spray Aircraft/Boom sprayer Rotational/plant back crop restriction. Geographic allowable: MT ND SD Low volume spray (concentrate)/Spray Aircraft/Boom sprayer Internode elongation Postharvest vTN Tillering 0.5 Ib 0.5 Ib 0.5 Ib Maximum # Applications per Year 1 2 2 Maximum Yearly Rate 0.25 Ib l.Slb l.Slb 45 day(s) pregrazing interval. Buffer zone restriction. 2 2 2 1.0 Ib 1.0 Ib 1.0 Ib 119 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A 2-Ethylhexyl ester Low volume spray (concentrate)/ Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground Broadcast/Chemigationi/Low volume spray (concentrate )/Spr, Aircraft/Boom sprayer/Ground/Low volume ground sprayer/Sprinkler irrigation Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Low volume ground sprayer Low volume spray (concentrate)/Spray Aircraft/Ground Early spring Fall y Postemergence Postharvest Tillering 0.75 Ib 0.4625 Ib 0.75 Ib 0.5 Ib 0.4875 Ib Maximum it Applications per Year Maximum Yearly Rate 14 day(s) preforage interval (animals being finished for slaughte: 14 day(s) preforage interval (dairy animals). 14 day(s) pregrazing interval (dairy animals). 45 day(s) pregrazing interval. 7 day(s) prefeeding interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval ( meat animals being finished for slaughter). 7 day(s) pregrazing interval. 1 1 2 2 2 0.75 Ib 0.4625 Ib l.Slb 1.0 Ib 0.975 Ib 120 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate RYE-LEGUME MIXTURE Sodium Salt Broadcast/Low volume spray (concentrate) Aircraft/Low pressure ground sprayer Spray Aircraft Early jointing Tillering 0.5 Ib 0.25 Ib Dimethylamine Salt Spray Low pressure Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer/Sprayer Internode elongation Late tillering Tillering 0.24585 Ib 0.25 Ib 0.5 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 1.0 Ib 0.50 Ib 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 0.4917 Ib 0.50 Ib 1.0 Ib ). *)• 121 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Maximum it Applications per Year Maximum Yearly Rate SMALL GRAM-LEGUME MIXTURE Dimethylamine Salt Spray Low pressure ground sprayer Tillering 0.23125 Ib 2-Ethylhexyl ester Low volume spray (concentrate) Aircraft/Low pressure ground sprayer Foliar 0.24375 Ib 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 0.4625 Ib 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 0.4875 Ib SMALL GRAINS Dimethylamine Salt Low volume Spray (concentrate) Aircraft/Ground Early spring 0.25 Ib 1 0.25 Ib TREFOIL Dimethylamine Salt Spray Aircraft/Ground Late tillering 0.25 Ib 2 0.50 Ib SORGHUM 122 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Spray Aircraft/Ground Early jointing Postemergence 0.75 Ib 0.75 Ib Maximum it Applications per Year Maximum Yearly Rate 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 2 2 l.Slb l.Slb TRITICALE 2-Ethylexyl ester Chemigation/Spray Aircraft/Ground/Sprinkler irrigation Postemergence 0.24375 Ib Geographic allowable: OR 2 0.46875 WHEAT Sodium Salt Broadcast Aircraft/Low pressure ground sprayer Early boot 0.75 Ib 7 days(s) preforage interval (animals being finished for slaughte 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 l.Slb 123 ------- Site Application Type Application Equipment Broadcast Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Spot treatment/Spray Aircraft/Low pressure ground sprayer ApplicationTiming Early jointing Postemergence Tillering Max. Single Application Rate (AE)A 0.75 Ib 0.75 Ib 0.75 Ib Dimethylamine Salt Spray Aircraft/Ground Low volume spray (concentrate )/Spray Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground Foliar Internode elongation Postemergence 0.75 Ib 0.75 Ib 0.75 Ib Maximum it Applications per Year 2 2 2 Maximum Yearly Rate l.Slb l.Slb l.Slb 14 day(s) preforage interval (animals being finished for slaughte: 14 day(s) pregrazing interval (dairy animals). 7 day(s) prefeeding interval. 7 day(s) preslaughter interval. 7 day(s) preforage interval (animals being finished for slaughter^ 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 l.Slb l.Slb l.Slb 124 ------- Site Application Type Application Equipment High volume spray (dilute)/Low volume spray (concentrate )/S treatment Aircraft/Ground/Low volume ground sprayer Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer Spray Aircraft/Ground ApplicationTiming 5ot Spring Tiller through boot Tillering When needed Max. Single Application Rate (AE)A 0.75 Ib 0.75 Ib 0.75 Ib 0.75 Ib Isooctyl ester Chemigation/Low volume spray (concentrate)/Spray Aircraft/Boom sprayer/Sprinkler irrigation Low volume spray (concentrate)/ Spray Aircraft/Boom sprayer Low volume spray (concentrate)/Spray Tillering Aircraft/Boom sprayer Rotational/plant back crop restriction. Geographic allowable: MT ND SD Internode elongation Postharvest Postharvest vTN 0.5 Ib 0.5 Ib 0.5 Ib Maximum # Applications per Year 1 2 2 2 45 day(s) pregrazing interval. Buffer zone restriction. 2 2 2 Maximum Yearly Rate 0.75 Ib l.Slb l.Slb l.Slb 1.0 Ib 1.0 Ib 1.0 Ib 125 ------- Site Application Type Application Equipment ApplicationTiming Max. Single Application Rate (AE)A 2-Ethylhexyl ester Low volume spray (concentrate)/Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground Broadcast/Low volume spray (concentrate) Aircraft/Boom sprayer/Low volume ground sprayer Early spring Fall Foliar 0.75 Ib 0.4625 Ib 0.39375 Ib Maximum it Applications per Year Maximum Yearly Rate 7 day(s) preforage interval (animals being finished for slaughter" 14 day(s) preforage interval ( animals being finished for slaughte 14 day(s) preforage interval (dairy animals). 14 day(s) pregrazing interval ( dairy animals). 14 day(s) preharvest interval (dry hay). 40 day(s) preharvest interval (grain). 45 day(s) pregrazing interval. 60 day(s) preharvest interval. 7 day(s) prefeeding interval. 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals) 7 day(s) pregrazing interval (dairy animals) 7 day(s) pregrazing interval (meat animals being finished for slaughter). 7 day(s) pregrazing interval. 7 day(s) preharvest interval (forage). 1 1 2 0.75 Ib 0.4625 Ib 0.7875 Ib 0- 126 ------- Site Application Type Application Equipment Broadcast/Chemigation/Low volume spray (concentrate)/Spo1 treatment/Spray Aircraft/Backpack sprayer/Boom sprayer/Ground/Hand held sprayer/Low pressure ground sprayer/Low volume ground sprayer/Sprinkler irrigation Low volume spray (concentrate)/Spray Aircraft/Hand held sprayer/Low volume ground sprayer Geographic allowable: MN, MT, ND, SD Low volume spray (concentrate)/ Spot treatment Aircraft/Hand held sprayer/ Low volume ground sprayer Low volume spray (concentrate)/Spray Aircraft/Ground/Low volume ground sprayer ApplicationTiming Postemergence Postharvest Spring Tillering Max. Single Application Rate (AE)A 0.75 Ib 0.5 Ib 0.6844 Ib 0.4875 Ib Maximum # Applications per Year 2 2 1 2 Maximum Yearly Rate l.Slb 1.0 Ib 0.6844 Ib 0.975 Ib WHEAT-LEGUME MIXTURE Sodium Salt Broadcast/Low volume spray (concentrate) Aircraft/Low pressure ground sprayer Early jointing 0.5 Ib 7 days(s) preforage interval (animals being finished for slaughte: 7 days(s) pregrazing interval (meat animals being finished for slaughter). 14 days(s) preforage interval (animals being finished for slaught 14 days(s) pregrazing interval (meat animals being finished for slaughter). 2 1.0 Ib 127 ------- Site Application Type Application Equipment Spray Aircraft ApplicationTiming Tillering Max. Single Application Rate (AE)A 0.25 Ib Dimethylamine Salt Spray Low pressure Spray Aircraft/Ground Low volume spray (concentrate)/Spray Aircraft/Ground/Low pressure ground sprayer/Sprayer Internode elongation Late tillering Tillering 0.24585 Ib 0.25 Ib 0.5 Ib Maximum it Applications per Year 2 Maximum Yearly Rate 1.0 Ib 7 day(s) preforage interval (animals being finished for slaughter" 7 day(s) preforage interval (dairy animals). 7 day(s) pregrazing interval (dairy animals). 7 day(s) pregrazing interval (meat animals being finished for slaughter). 2 2 2 0.4917 Ib 0.50 Ib 1.0 Ib 128 ------- Use Site Max. Rate per App. Max Rate Unit/Area *UG Form Max. # Apps. CC&yr Max. App. Rate/ CC & yr Min. App Interval (days) Application Equipment /Type (Reg # Code) MCPA Acid Commercial/ Industrial lawns Commercial/ Institutional/ Industrial Premises/ Equipment (outdoor) Golf Course Turf Household/ Domestic Dwellings Outdoor Premises Nonagricultural Uncultivatec Areas/ Soils Ornamental Lawns and Turf 1.33 .0020 1.2972 1.33 .0020 .0328 1.2972 1.33 .0020 .0328 1.33 .0020 .0343 IbA gal IK sq.ft *C1 IbA IbA gal IK sq.ft *C1 Ib IK sq.ft *C1 IbA IbA gal IK sq.ft *C1 Ib IK sq.ft *C1 IbA gal IK sq.ft *C2 Ib IK sq.ft *C2 SC/S SC/S SC/S SC/S SC/S G SC/S SC/S SC/S G SC/S SC/S G NS NS NS 2/1 yr 2/1 yr 2/1 yr NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS 21 21 21 NS NS NS NS NS NS NS Sprayer //Spray (a) Controlled droplet applicator //Spray (b) Sprayer //Broadcast (a) Sprayer //Spray (a) Controlled droplet applicator //Spray (b) Spreader //Broadcast (c) Sprayer //Broadcast (a) Sprayer //Spray (a) Controlled droplet applicator //Spray (b) Spreader //Broadcast (c) Sprayer //Spray (a) Controlled droplet applicator //Spray (b) Spreader //Broadcast (c) 129 ------- Use Site Recreation Area Lawns Recreational Areas Residential Lawns Urban Areas Max. Rate per App. 1 1.33 .0020 .0328 .0262 1.2972 .0276 1 .0276 1 Max Rate Unit/Area *UG -(L) *C2 IbA gal IK sq.ft *C1 Ib IK sq.ft *C1 Ib IK sq.ft *C1 IbA Ib IK sq.ft *K1 -(L) *K1 Ib IK sq.ft *C2 -(L) *C2 Form G sc/s sc/s G G SC/S G G G G Max. # Apps. CC&yr NS NS NS NS NS 2/1 yr 2/1 yr 2/1 yr NS NS Max. App. Rate/ CC & yr NS NS NS NS NS NS NS NS NS NS Min. App Interval (days) 28 30 NS NS NS NS 30 NS 21 21 21 30 30 Application Equipment /Type (Reg # Code) Spreader //Broadcast/ Spot treatment (d) Sprayer //Spray (a) Controlled droplet applicator //Spray (b) Spreader //Broadcast (c) Spreader //Broadcast (a) Sprayer //Broadcast (a) Spreader //Broadcast (b) Spreader //Spot treatment (c) Spreader //Broadcast (a) Spreader //Spot treatment (b) Use Site/Registration Number(s) for Maximum Dosages with Reg # Codes Commercial/ Industrial Lawns Commercial/ Institutional/ Industrial Premises/ Equipment (Outdooi Golf Course Turf Household/ Domestic Dwellings Outdoor Premises 228-228(b), 228-285(a) 2217-784(a) 228-228(b), 228-285(a), 228-306(c) 2217-784(a) 130 ------- Use Site Max. Rate per App. Max Rate Unit/Area *UG Form STonagricultural Uncultivated Areas/ Soils Ornamental Lawns and Turf Recreation Area Lawns Recreational Areas Residential Lawns Urban Areas Sodium Salt Agricultural Rights-of-Way/ Fence Rows/ Hedgerows Agricultural Uncultivated Areas Grasses Grown for Seed Industrial Areas (Outdoor) STonagricultural Rights-of-Way/ Fence Rows Hedgerows 3.2706 .1289 3.272 .1289 1.0902 3.094 .1289 3.094 Ib A lb/3 gal *C1 Ib A lb/3 gal *C1 Ib A Ib A lb/3 gal *C1 IbA SC/L EC EC EC SC/L EC EC EC Max. # Apps. CC&yr Max. App. Rate/ CC & yr Min. App Interval (days) Application Equipment /Type (Reg # Code) 228-228(b), 228-285(a), 228-306(c) 228-228(b), 228-285(a), 538-160(d), 538-2 18(d), 538-222(d), 2217-798(d), 9198-198(c) 228-228(b), 228-285(a), 228-306(c) 228-300(a),2217-822(a) 2217-784(a), 2217-798(b,c) 2217-798(a,b) NS NS NS NS 2/1 yr NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS 21 NS NS NS Aircraft/ Ground //Spray (a) Low pressure ground sprayer //Spot treatment (b) Aircraft/ Low pressure ground sprayer //Broadcast/ Spot treatment (a) Low pressure ground sprayer //Spot treatment (b) Aircraft/ Ground //Broadcast (a) Aircraft/ Low pressure ground sprayer //Low volume spray (concentrate) (a) Low pressure ground sprayer //Spot treatment (b) Aircraft/ Low pressure ground sprayer //Low volume spray (concentrate) (a) 131 ------- Use Site STonagricultural Uncultivatec Areas/ Soils Ornamental Lawns and Turf Ornamental Sod Farm (Turf) Max. Rate per App. .1289 3.272 .1289 1.636 .0341 1.5 .0341 Max Rate Unit/Area *UG lb/3 gal *C1 Ib A lb/3 gal *C1 Ib A Ib IK sq.ft *C2 IbA Ib IK sq.ft *C1 Form EC EC EC EC SC/L SC/L SC/L Max. # Apps. CC&yr NS NS NS NS NS 2/1 yr 2/1 yr Max. App. Rate/ CC & yr NS NS NS NS NS NS NS Min. App Interval (days) NS NS NS NS NS 21 21 Application Equipment /Type (Reg # Code) Low pressure ground sprayer //Spot treatment (b) Aircraft/ Low pressure ground sprayer //Broadcast/ Spot treatment (a) Low pressure ground sprayer //Spot treatment (b) Aircraft/ Low pressure ground sprayer //Broadcast (a) Ground //Spot treatment (b) Aircraft/ Ground //Broadcast (a) Ground //Spot treatment (b) Use Site/Registration Number(s) for Maximum Dosages with Reg # Codes Agricultural Rights-of-Way/ Fence Rows/ Hedgerows Agricultural Uncultivated Areas Grasses Grown for Seed Industrial Areas (Outdoor) STonagricultural Rights-of-Way/ Fence Rows/ Hedgerows STonagricultural Uncultivated Areas/ Soils Ornamental Lawns and Turf Ornamental Sod Farm (Turf) 42750-24(b), 62719-58(a) 5905-5 10(a),42750-24(b) 62719-58(a) 42750-24(a,b) 42750-24(a,b) 5905-5 10(a),42750-24(b) 5905-510(a), 62719-58(b) 62719-58(a,b) Dimethylamine Salt 132 ------- Use Site Agricultural Fallow/ Idleland Agricultural Rights-of-Way/ Fence Rows/ Hedgerows Agricultural Uncultivated Areas Airports/ Landing Fields Commercial/ Industrial Lawn Drainage Systems Max. Rate per App. 3.6801 2.441 .1533 3.673 .1530 3.673 .1530 3.406 .1419 11816 .0350 3.406 .0788 Max Rate Unit/Area *UG Ib A lb/.5 gal *C1 lb/3 gal *C1 Ib A lb/3 gal *C1 IbA lb/3 gal *C1 IbA lb/3 gal *C1 IbA Ib IK sq.ft *C1 IbA Ib IK sq.ft *F1 Form EC EC EC SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L EC Max. # Apps. CC&yr NS NS NS NS NS NS NS NS NS NS NS NS NS Max. App. Rate/ CC & yr NS 3 Ib (L)/cc NS NS NS NS NS NS NS .3633 Ib/cc NS NS NS Min. App Interval (days) NS NS NS NS NS NS NS NS NS 10 NS NS NS Application Equipment /Type (Reg # Code) Aircraft/ Ground //Spray (a) Ground //Spot treatment (b) Ground //Spot treatment (c) Ground //Spray (a) Ground //Spot treatment (b) Ground //Spray (a) Ground //Spot treatment (b) Aircraft/ Ground //Spray (a) Ground //Spot treatment (b) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (a) Ground //Spray (b) Aircraft/ Ground //Spray (a) Sprayer //Spray (b) 133 ------- Use Site Forest Plantings (Reforestation Programs)(Tr<; Farms, Tree Plantations, etc.; Forest Trees (All or Unspecified) Golf Course Turf Grasses Grown for Seed Household/ Domestic Dwellings Outdoor Premises Nonagricultural Rights-of-Way/ Fence Rows Max. Rate per App. .0034 .1419 4.913 1.426 .8764 .1816 1.5 .0400 .1538 1.5 .0088 Ib IK s *K1 .1816 Max Rate Unit/Area *UG M234375 gal *F1 lb/3 gal *F1 Ib A IbA Ib A IbA IbA Ib IK sq.ft *C1 lb/3 gal *C1 IbA PENS IbA Form EC SC/L SC/L SC/L SC/L SC/L EC SC/L EC SC/L NS21 SC/L Max. # Apps. CC&yr 2/1 yr NS NS NS 2/1 yr 2/1 yr 2/1 yr 2/1 yr 2/1 yr 2/1 yr Hose-end sprayer/ Sprayer //Broadcast (a) NS Max. App. Rate/ CC & yr NS NS 4.913 Ib/cc NS NS .3633 Ib/cc NS NS NS NS .3633 Ib/cc Min. App Interval (days) 21 NS NS NS 21 10 21 21 21 21 10 Application Equipment /Type (Reg # Code) Trigger spray bottle //Spot treatment (c) Ground //Spot treatment (d) Aircraft/ Ground/ High volume ground sprayer //Broadcast/ Spot treatment (a) Ground //Spray (a) Sprayer //Spray (a) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (b) Ground //Broadcast/ Spray (c) Controlled droplet applicator //Spray (d) Ground //Spot treatment (e) Aircraft/ Ground //Spray (a) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer 134 ------- Use Site Hedgerows STonagricultural Uncultivatec Areas/ Soils Max. Rate per App. 4.913 3.6801 .3194 .0485 2.441 .1816 4.913 3.6801 .3194 .0034 .0485 2.441 Max Rate Unit/Area *UG IbA IbA Ib IK sq.ft *C2 lb/1 gal *C2 lb/3 gal *C1 IbA IbA IbA Ib IK sq.ft *C1 M234375 gal *C1 lb/1 gal *C1 lb/3 gal *C1 Form SC/L EC SC/L SC/L SC/L EC SC/L SC/L EC SC/L EC SC/L EC Max. # Apps. CC&yr NS NS NS NS NS NS NS NS NS 2/1 yr NS NS Max. App. Rate/ CC & yr 4.913 Ib/cc NS NS NS NS .3633 Ib/cc 4.913 Ib/cc NS NS NS NS 3 Ib (L)/cc Min. App Interval (days) NS NS NS NS NS 10 NS NS NS 21 NS NS Application Equipment /Type (Reg # Code) //Spray (a) Aircraft/ Ground/ High volume ground sprayer //Broadcast/ Spot treatment (b) Aircraft/ Ground/ Sprayer //Spray (c) Sprayer //Spray (d) Tank-type sprayer //Spot treatment (e) Ground //Spot treatment (f) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (a) Aircraft/ Ground/ High volume ground sprayer //Broadcast/ Spot treatment (b) Aircraft/ Ground //Spray (c) Sprayer //Spray (d) Trigger spray bottle //Spot treatment (e) Tank-type sprayer //Spot treatment (f) Ground //Spot treatment (g) 135 ------- Use Site Ornamental Lawns and Turf Max. Rate per App. 2.441 1.753 .1816 2.461 .0300 .6533 .0520 .0013 .0034 .0169 8.250E-04 .0126 Max Rate Unit/Area *UG lb/3 gal *C1 Ib A IbA Ib A Ib IK sq.ft *C2 Ib IK sq.ft *C2 Ib IK sq.ft *C2 M234375 gal *C2 M234375 gal *C2 Vol. 25 gal *C2 Vol.25 gal *C2 lb/.5 gal Form EC SC/L SC/L EC RTU G G RTU ECNS EC SC/L SC/L Max. # Apps. CC&yr NS 2/1 yr NS NS 2/cc 2/1 yr NS 2/cc NS21 2/cc NS NS Max. App. Rate/ CC & yr NS NS .3633 Ib/cc NS NS NS NS NS Sprayer //Spot treatment (h) NS NS NS Min. App Interval (days) NS NS 10 NS 30 30 30 21 28 NS NS Application Equipment /Type (Reg # Code) Ground //Spot treatment (h) Atomizing type sprayer/ Spinning-disc sprayer/ Sprayer //Low volume spray (concentrate)/ Spray (a) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (b) Ground //Broadcast/ Spray (c) Hose-end sprayer //Spray (d) Spreader //Broadcast (e) Spreader //Broadcast (f) Trigger spray bottle //Spot treatment (g) Sprayer //Spot treatment (i) Ground //Spot treatment (j) Sprayer 136 ------- Use Site Ornamental Sod Farm (Turf) Max. Rate per App. .0274 .1538 1 1 3.2 1.5 .1816 1.5 .0398 .0383 Max Rate Unit/Area *UG *C2 lb/1 gal *C2 lb/3 gal *C1 -(L) *C2 -(L) *C2 fl.oz IK sq.ft (L) *C2 IbA IbA IbA Ib IK sq.ft *C1 Ib IK sq.ft *C1 Form SC/L EC PRL RTU RTU SC/L SC/L SC/L SC/L SC/L SC/L SC/L Max. # Apps. CC&yr 2/1 yr NS 2/cc NS NS 2/1 yr 2/1 yr 2/1 yr 2/1 yr 2/1 yr Max. App. Rate/ CC & yr NS NS NS NS NS NS .3633 Ib/cc NS NS NS Min. App Interval (days) NS NS 21 14 AN NS NS 21 10 21 21 21 Application Equipment /Type (Reg # Code) //Spot treatment (k) Sprayer //Spot treatment (1) Ground //Spot treatment (m) Aerosol can/ Trigger spray bottle //Spot treatment (n) Product container/ Sprayer/ Trigger spray bottle //Spot treatment/ Spray (o) Hose-end sprayer //Broadcast (p) Atomizing type sprayer/ Spinning-disc sprayer/ Sprayer //Low volume spray (concentrate)/ Spray (a) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (b) Ground //Spray (c) Controlled droplet applicator //Spray (d) Sprayer //Spot treatment (e) 137 ------- Use Site Paved Areas (Private Roads/ Sidewalks) Recreation Area Lawns Recreational Areas Residential Lawns Max. Rate per App. .0274 3.406 .1419 .1816 1.72 .0391 .1816 1.76 .0400 .0126 .1816 Max Rate Unit/Area *UG lb/1 gal *C1 IbA lb/3 gal *C2 IbA IbA Ib IK sq.ft *C1 IbA IbA Ib IK sq.ft *C1 lb/.5 gal *C1 IbA Form SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L SC/L Max. # Apps. CC&yr 2/1 yr NS NS NS NS NS NS NS NS NS 2/1 yr Max. App. Rate/ CC & yr NS NS NS .3633 Ib/cc NS NS .3633 Ib/cc NS NS NS .3633 Ib/cc Min. App Interval (days) 21 NS NS 10 NS NS 10 NS NS NS 10 Application Equipment /Type (Reg # Code) Sprayer //Spot treatment (f) Aircraft/ Ground //Spray (a) Ground //Spot treatment (b) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (a) Atomizing type sprayer/ Spinning-disc sprayer/ Sprayer //Low volume spray (concentrate)/ Spray (b) Controlled droplet applicator //Spray (c) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (a) Spinning-disc sprayer/ Spoon //Spray (b) Controlled droplet applicator //Spray (c) Sprayer //Spot treatment (d) Hose-end sprayer/ Knapsack sprayer/ Pump-up sprayer //Spray (a) 138 ------- Use Site Shelterbelt Plantings Urban Areas Max. Rate per App. .0166 .0316 .0126 1 3.673 .1530 .0335 .0126 Max Rate Unit/Area *UG Ib IK sq.ft *K1 Ib IK sq.ft *K1 lb/.5 gal *K1 -(L) *K1 IbA lb/3 gal *J1 Ib IK sq.ft *C2 lb/.5 gal *C1 Form SC/L SC/L SC/L RTU SC/L SC/L SC/L SC/L Max. # Apps. CC&yr 2/cc 2/1 yr 2/1 yr 2/1 yr NS NS NS NS Max. App. Rate/ CC & yr NS NS NS NS NS NS NS NS Min. App Interval (days) 14 21 21 14 NS NS NS NS Application Equipment /Type (Reg # Code) Backpack sprayer/ Knapsack sprayer/ Pump-up sprayer //Broadcast (b) Pressure sprayer/ Tank-type sprayer //Spray (c) Sprayer //Spot treatment (d) Trigger spray bottle //Spot treatment (e) Ground //Spray (a) Ground //Spot treatment (b) Hose-end sprayer //Spray (a) Sprayer //Spot treatment (b) 139 ------- Use Site Max. Rate Max Rate Form perApp. Unit/Area *UG Max. # Max. App. Min. App Application Equipment Apps. Rate/CC& Interval /Type CC&yr yr (days) (Reg # Code) Use Site/Registration Number(s) for Maximum Dosages with Reg # Codes Agricultural Fallow/ Idleland Agricultural Rights-of-Way/ Fence Rows/ Hedgerows Agricultural Uncultivated Areas Airports/ Landing Fields Commercial/ Industrial Lawns Drainage Systems Forest Plantings (Reforestation Programs)(Tree Farms, Tree Planta etc.) Forest Trees (All or Unspecified) Golf Course Turf Grasses Grown for Seed Household/ Domestic Dwellings Outdoor Premises STonagricultural Rights-of-Way/ Fence Rows/ Hedgerows STonagricultural Uncultivated Areas/ Soils Ornamental Lawns and Turf Ornamental Sod Farm (Turf) Paved Areas (Private Roads/ Sidewalks) Recreation Area Lawns Recreational Areas Residential Lawns Shelterbelt Plantings Urban Areas 228-290(b), 1386-587(a,c) 62719-13(a,b) 6271 9-1 3(a,b) 1381-104(a,b) 2217-729(b), 7969-78(a) 228-271(b,c), 1381-104(a,d) iaa§,-296(a) 228-143(a) 228-313(d), 228-371(a), 2217-362(c,e), 7969-78(b) 228-143(a) 2217-785(a) 228-206(d,e), 228-290(f), 228-296(b), 1386-587(c), 5905-502(c), 7969-78(a) 228-206(d,f), 228-271(e), 228-290(g,h), 228-296(b), 1386-587(c), 7969-78(a) 228-224(n), 228-272(g), 228-276(d), 228-284(n), 228-310(h,i), 228-324(f), 228-334(o), 228-336(o), 228-349(o,p), 228-351(0), 228-353(fj, 228-371(a,l), 239-2634(o), 2217-362(c,m), 2217-732G), 2217-734(k), 2217-744(e), 2217-792(o), 7969-78(b) 228-371(a,d,f), 7969-78(b), 62719-13(c,e) 1381-104(a,b) 228-372(b,c), 7969-78(a) 228-3 13(b,c), 2217-734(d), 7969-78(a) 2217-733(b), 2217-734(c,d), 2217-792(e), 7969-78(a) 6271 9-1 3(a,b) 2217-734(b),2217-735(a) 140 ------- Use Site Max. Rate per App. Max Rate Unit/Area *UG Form Max. # Apps. CC&yr Max. App. Rate/ CC & yr Min. App Interval (days) Application Equipment /Type (Reg # Code) 2, Ethylhexyl Ester agricultural fallow/idleland agricultural rights-of-way/fencerows/hec rows agricultural uncultivated are; 1.537 4.345 3 .0349 .1250 4.313 ge 1.537 4.313 .0349 Ib A IbA IbA Ib IK sq.ft *C1 lb/3 gal *C1 IbA IbA IbA Ib IK sq.ft *C1 EC EC EC EC EC EC EC EC EC 1/cc 1/cc NS 1/cc NS NS NS NS NS 1.5371b/cc NS NS 1.5371b/cc NS NS 1.5371b/cc NS 1.5371b/cc NS NS NS NS NS NS NS NS NS Aircraft/ Ground/ Low pressure ground sprayer //Broadcast/ Low volume spray (concentrate) (a) Aircraft/ Hand held sprayer/ Low volume ground sprayer //Low volume spray (concentrate)/ Spot treatment (b) Aircraft/ Ground //Spray (c) Backpack sprayer/ Hand held sprayer //Spot treatment (d) Ground //Spot treatment (e) Aircraft/ Ground //Spray (a) Low pressure ground sprayer //Broadcast (a) Aircraft/ Ground //Spray (b) Backpack sprayer/ Hand held sprayer 141 ------- Use Site airports/landing fields commercial/industrial lawns commercial/institutional/indi rial premises/equipment (outdoor) forest trees (all or unspecifiei golf course turf Max. Rate per App. 1.6575 .0380 1.6575 2.686 .0380 .0313 it6575 .0380 ^.Olll 1.5 Max Rate Unit/Area *UG Ib A Ib IK sq.ft *C1 IbA Ib A Ib IK sq.ft *C1 Ib IK sq.ft *C1 IbA Ib IK sq.ft *C1 IbA IbA Form EC EC EC EC EC EC EC EC EC EC Max. # Apps. CC&yr 2/1 yr 2/1 yr 2/1 yr NS 2/1 yr NS 2/1 yr 2/1 yr NS 2/1 yr Max. App. Rate/ CC & yr NS NS NS NS NS NS NS NS NS NS Min. App Interval (days) 14 14 14 NS 14 AN 14 14 NS 14 Application Equipment /Type (Reg # Code) //Spot treatment (c) Boom sprayer //Broadcast (a) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (b) Backpack sprayer //Broadcast (a) Sprayer //Broadcast/ Spot treatment (b) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (c) Hand held sprayer //Spot treatment (d) Boom sprayer //Broadcast (a) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (b) Aircraft/ Ground //Low volume spray (concentrate)/ Spray (a) Backpack sprayer 142 ------- Use Site grasses grown for seed lousehold/domestic dwellirij outdoor premises Max. Rate per App. 1.5 .0380 .0360 .7735 1.5 1.5 i.6575 .0380 Max Rate Unit/Area *UG Ib A Ib IK sq.ft *C1 Ib IK sq.ft *C1 Ib A Ib A Ib A IbA Ib IK sq.ft *K1 Form EC EC G EC EC EC EC EC Max. # Apps. CC&yr NS 2/1 yr NS NS NS NS 2/1 yr 2/1 yr Max. App. Rate/ CC & yr NS NS NS .7735 Ib/cc 1.601 Ib/cc NS NS NS Min. App Interval (days) NS 14 30 NS AN NS NS 14 Application Equipment /Type (Reg # Code) //Broadcast (a) Sprayer //Broadcast/ Spot treatment (b) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (c) Spreader //Broadcast (d) Aircraft/ Boom sprayer/ Low volume ground sprayer/ Sprinkler irrigation //Chemigation/ Low volume spray (concentrate)/ Spray (a) Aircraft/ Hand held sprayer/ Low volume ground sprayer //Low volume spray (concentrate)/ Spot treatment (b) Aircraft/ Ground //Spray (c) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Broadcast (a) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (b) 143 ------- Use Site nonagricultural rights-of-way/fencerows/hec rows nonagricultural uncultivated areas/soils Max. Rate per App. 4.359 ge 1.6575 4.388 .0380 .0823 .0256 .3584 .7500 3.659 4.313 Max Rate Unit/Area *UG IbA Ib A IbA Ib IK sq.ft *C2 Ib IK sq.ft *C1 lb/1 gal *C1 lb/3 gal *C1 gal(L) *C1 IbA IbA Form EC EC EC EC EC EC EC EC EC EC Max. # Apps. CC&yr 2/cc 2/1 yr NS 2/1 yr NS NS NS NS 1/cc 2/cc Max. App. Rate/ CC & yr NS NS NS NS NS NS NS NS NS NS Min. App Interval (days) AN 14 AN 14 NS NS AN NS NS AN Application Equipment /Type (Reg # Code) Aircraft/ Ground //Spray (a) Boom sprayer //Broadcast (b) Aircraft/ Ground //Spray (c) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (d) Sprayer //Spray (e) Tank-type sprayer //Spot treatment (f) Ground //Spot treatment (g) Ground //Spot treatment/ Spray (h) Aircraft/ Hand held sprayer/ Low volume ground sprayer //Low volume spray (concentrate)/ Spot treatment (a) Aircraft/ Ground //Spray (b) 144 ------- Use Site ornamental lawns and turf ornamental sod farm (turf) Max. Rate per App. 4.388 .0823 .0256 4.332 .7500 1.6575 2.686 .0380 .0313 1.6575 .5000 Max Rate Unit/Area *UG IbA Ib IK sq.ft *C1 lb/1 gal *C1 lb/3 gal *C1 gal(L) *C1 IbA IbA Ib IK sq.ft *C2 Ib IK sq.ft *C1 IbA IbA Form EC EC EC EC ECNS EC EC EC EC EC EC Max. # Apps. CC&yr NS NS NS NS NSNS 2/1 yr NS 2/1 yr NS 2/1 yr NS Max. App. Rate/ CC & yr NS NS NS NS Ground //Spot treatment (g) NS NS NS NS NS .5 Ib/cc Min. App Interval (days) AN NS NS NS 14 NS 14 AN 14 NS Application Equipment /Type (Reg # Code) Aircraft/ Ground //Spray (c) Sprayer //Spray (d) Tank-type sprayer //Spot treatment (e) Ground //Spot treatment (f) Backpack sprayer //Broadcast (a) Sprayer //Broadcast/ Spot treatment (b) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (c) Hand held sprayer //Spot treatment (d) Backpack sprayer //Broadcast (a) Aircraft/ Ground/ Sprinkler 145 ------- Use Site recreation area lawns recreational areas Max. Rate per App. 1.5 .0380 .0313 2.686 .0360 1.6575 1.093 .0380 .0256 Max Rate Unit/Area *UG IbA Ib IK sq.ft *C1 Ib IK sq.ft *C1 IbA Ib IK sq.ft *C1 IbA IbA Ib IK sq.ft *C1 Ib IK sq.ft *C1 Form EC EC EC EC GNS EC EC EC EC Max. # Apps. CC&yr NS 2/1 yr NS NS NS30 2/1 yr NS 2/1 yr NS Max. App. Rate/ CC & yr NS NS NS NS Spreader //Broadcast (b) NS NS NS NS Min. App Interval (days) AN 14 AN NS 14 NS 14 NS Application Equipment /Type (Reg # Code) irrigation //Chemigation/ Spray (b) Aircraft/ Ground //Broadcast/ Spray (c) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (d) Hand held sprayer //Spot treatment (e) Sprayer //Broadcast/ Spot treatment (a) Boom sprayer //Broadcast (a) Sprayer //Spray (b) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (c) Low volume sprayer //Low volume spray (concentrate) (d) 146 ------- Use Site residential lawns urban areas Max. Rate per App. 2.686 .0360 1.6575 .0380 Max Rate Unit/Area *UG IbA Ib IK sq.ft *K1 IbA Ib IK sq.ft *C2 Form EC G EC EC Max. # Apps. CC&yr NS NS 2/1 yr 2/1 yr Max. App. Rate/ CC & yr NS NS NS NS Min. App Interval (days) NS 30 14 14 Application Equipment /Type (Reg # Code) Sprayer //Broadcast/ Spot treatment (a) Spreader //Broadcast (b) Boom sprayer //Broadcast (a) Backpack sprayer/ Compression sprayer/ Knapsack sprayer //Spot treatment (b) Use Site/Registration Number(s) for Maximum Dosages with Reg # Codes agricultural fallow/idleland agricultural rights-of-way/fencerows/hedgerows agricultural uncultivated areas airports/landing fields commercial/industrial lawns commercial/institutional/industrial premises/equipment (outdoor) forest trees (all or unspecified) golf course turf grasses grown for seed lousehold/domestic dwellings outdoor premises nonagricultural rights -of-way/fencerows/hedgerows 5905-506(c,e), 62719-86(b), 62719-307(a,d) 11685-21(a) 11685-21(b), 62719-307(a,c) 2217-834(a,b) 2217-803(b), 2217-834(a,c), 62719-59(d) 2217-834(a,b) 228-267(a) 228-203(d), 2217-803(b), 2217-834(a,c) 228-267(c), 51036-254(a), 62719-86(b) 2217-834(a,b) 228-205(f), 228-317(e), 1381-98(g), 2217-834(b,d), 9779-265(h), 42750-23(h), 42750-25(h), 71368-16(a), 71368- 17(c) 147 ------- Use Site Max. Rate per App. Max Rate Unit/Area *UG Form Max. # Apps. CC&yr Max. App. Rate/ CC & yr Min. App Interval (days) Application Equipment /Type (Reg # Code) nonagricultural uncultivated areas/soils 228-205(e), 228-317(d), 11685-21(b), 42750-23(f,g), 42750-25(g), 62719-86(a), 71368-17(c) ornamental lawns and turf 2217-803(b), 2217-834(a,c), 62719-59(d) ornamental sod farm (turf) 264-690(b), 2217-834(a,d), 62719-59(c,e) recreation area lawns 228-203(b), 2217-803(a) recreational areas 228-205(b,d), 2217-834(a,c) residential lawns 228-203(b), 2217-803(a) urban areas 2217-834(a,b) HEADER ABBREVIATIONS Use Site Max.Rate per App Max.Rate Unit/Area *UG Form Max. # Apps cc & yr Max. App Rate/cc & yr Min. App Interval (days) Application Equipment Application Type Current as of - The use site refers to the entity (crop, building, surface or article) where a pesticide is applied and/or which is being protected. Maximum dose for a single application to a single site. System calculated. Units and Area associated with the maximum dose. Use Group codes. The physical form of the end use product found in the container. The maximum number of applications. The maximum amount of pesticide product that can be applied to a site in one growing season (/cc) or during the span of one year (/yr). The minimum retreatment interval between applications in days (aggregated). The equipment used to apply pesticide (aggregated). The type of pesticide application (aggregated). The label data for the listed products in this report is current as of this date ABBREVI AT IONS - The dosage information provided is from the label in terms of product (e.g., ounces, gallons, or pounds of the product) because there was insufficient information (e.g., missing density, area, c active ingredient percentages) to provide converted dosage information. - The tilde in "Max. Rate per App" indicates a dosage that includes information from a SLN label. 148 ------- APPLICATION RATE W PPM calculated by weight PPM calculated by volume Unknown whether PPM is given by weight or by volume Hundred Weight. nn times (10 power -xx), for instance, "1.234E-4" is equivalent to ".0001234". No description available in LUIS unit conversion vocabulary. The dosage information includes a contribution from one or more (TQ, CL, BR, I) active ingredients. FORMULATION CODES G : Granular SC/S : Soluble Concentrate/solid USE GROUP CODES Cl : TERRESTRIAL NON-FOOD CROP C2 : TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL Kl : OUTDOOR RESIDENTIAL 149 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT Use Patterns CITATION(S) PRODUCT CHEMISTRY New Guideline Number 830.1550 830.1600 830.1620 830.1700 830.1750 830.1800 Old Guideline Number 61-1 61-2A 61-2B 61-3 62-1 62-2 62-3 63-0 Product Identity and Composition Description of materials used to produce the product Description of production process Discussion of Formation of Impurities Preliminary Analysis Certification of limits Analytical Method Reports of Multiple Phys/Chem Characteristics A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K 44645801, 44914027, 43129310, 44484501, 4448502, 43227201, 4322702, 4322703, 4422706, 44401301, 44645801, 42377401, 42577601, 43986101, 44463901, 40470101, 41193401, 42079401, 44645801, 45084401, 44914027, 43129310 44639901, 44394401, 42386401, 42577601, 43986101, 158077, 42377401, 45804402, 4504403 42079401,42386401 45804404 44639901, 45804405, 45804406, 42386402, 42377410, 42450901, 42657101, 44394401, 42079402, 42577602, 43986102, 40470101, 44639901 44645802, 42377401, 42377402, 42377403, 43986102, 42377405, 42377409, 42450901, 42079403, 40470101, 44401301,42377410 43227203, 42377404, 42377406, 42377407, 42377408, 42577608, 43986102, 44259401, 40470101, 42079403, 42377405,44463901 44484504, 4484503, 4322702, 43227206, 53734 150 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT 830.6302 830.6303 830.6304 830.6313 830.700 830.6317 830.6320 830.7200 830.7300 830.7550 830.6314 830.7840 830.7950 63-2 63-3 63-4 63-13 63-12 63-17 63-20 63-5 63-7 63-11 63-14 63-8 63-9 Color Physical State Odor Stability to normal and elevated temperatures, metals, and metal ions PH Storage Stability Corrosion Characteristics Melting Point Density Partition coefficient, shake flask method Oxidation or reducing action Solubility Vapor Pressure Use Patterns A, B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A, B, C,K A,B, C,K A,B, C,K A, B, C,K A, B, C,K CITATION(S) 42450903, 42450902, 44861801 42450904 42757301 42450907,42757301 42450907 42638601, 45173401, 44484505, 444806, 45480901 44861801, 44929001, 44535802 42450905 42450906 40470101,40471801 44535801 40471802 40471803 ECOLOGICAL EFFECTS 850.2100 850.2200 71-1A 71-2A Avian Acute Oral Toxicity Avian Dietary Toxicity - Quail A,B, C,K A,B, C,K 40019201 40555803,4055802, Data Gap ( MCPA EHE) 151 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT 850.1075 850.1010 850.1075 850.1300 850.4225 850.4250 850.5400 850.4225 850.4400 850.3020 72-1A 72-2A 72-3A 72-4A 122-1A 122-1B 122-2 123-1A 123-2 141-1 Fish Toxicity Bluegill Invertebrate Toxicity Estuarine/Marine Toxicity - Fish Fish Early Life Stage - Daphnid Terrestrial Plant Toxicity, Seedling Emergence (Tier 11) Terrestrial Plant Toxicity, Vegetative Vigor (Tier II) Aquatic Plant Growth Seedling Germination and Seedling Emergence Aquatic Plant Growth Honey Bee Acute Contact Use Patterns A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K A,B, C,K CITATION(S) 40062004, 42624402, 41800904, 40062005, 41800901, 41800902, 41800905, 41800901, 41800902, 41800903 41800906,42412201 43083210, 40062006, 43086501 44407202,44407201 43083205, 46148, 43083205, Data Gap (MCPA Acid, DMAS, EHE) Data Gap (MCPA Acid, DMAS, EHE) 43126502, 42461301, 45554403, 43083207, 43083212, 43083213, 43083214, 43083206, 43083207, 43083208, 45503801,43083211 42698701, 42669304, 43788201, 43257901 44903501, 44903502, 44903504, 44903503, 45312207, 44903505 Data Gap (MCPA Acid, DMAS, EHE) 42197801, 42150301, 42197801 TOXICOLOGY 870.1100 870.1200 870.1300 870.2400 81-1 81-2 81-3 81-4 Acute Oral Toxicity-Rat Acute Dermal Toxicity-Rabbit/Rat Acute Inhalation Toxicity-Rat Primary Eye Irritation-Rabbit A,B, C,K A, B, C,K A,B, C,K A, B, C,K 21972(250090), (248567), 1156458 156459 40053101,42113103,156460 156522 152 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT 870.2600 870.6200 870.6300 870.3100 870.3200 870.3465 870.6200 870.4100 870.3700 870.3700 870.3800 870.5100 870.5375 870.7485 870.7600 870.7200 81-6 81-8 83-6 82-1A 82-2 82-4 82-7 83-1B 83-3A 83-3B 83-4 84-2 84-2B 85-1 85-3 86-1 Dermal Sensitization Acute Neurotoxicity Screen Study Developmental Neurotoxicity Study Subchronic Oral Toxicity: 90-Day Study Rodent 21-Day Dermal - Rabbit/Rat 90-Day Inhalation-Rat (28-Day abbreviated 90-day protocol) Subchronic Neurotoxicity Chronic Feeding Toxicity - Non- Rodent Developmental Toxicity - Rat Developmental Toxicity - Rabbit 2-Generation Reproduction - Rat Bacterial Reverse Gene Mutation Cytogenetics General Metabolism Dermal Penetration and Absorption Domestic Animal Safety Use Patterns A, B, C,K A, B, C,K A,B, C,K A,B, C,K A, B, C,K A, B, C,K A,B, C,K A,B, C,K A,B, C,K A, B, C,K A,B, C,K A, B, C,K A,B, C,K A,B, C,K A,B, C,K A, B, C,K CITATION(S) 43062806, 40352101, 41613003, 43556801 43562602, 43556702 Data Gap (MCPA EHE) 43562601, 165470, 165471,61368, 106595,43556802, 43556801, 43556701, 43556801 42715001 Data Gap (MCPA Acid) 45889301,43562601 40634101,40792301,164352 42723801, 42723802, 40041701, 44954102, 44954101 42723802 40041701 42840403, 42860103, 42853504, 40027501, 42860102, 148720, 42624401, 42860101, 148720, 4287001, 42853505, 42853502, 42624401, 42860101, 42853506 40027501 43755202, 45595301, 45595302 46327601,44192701 5003259 153 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT Use Patterns CITATION(S) OCCUPATIONAL/RESIDENTIAL EXPOSURE 875.1100 231 Estimation of Dermal Exposure, Outdoor Sites Data Gap (MCPA Acid) ENVIRONMENTAL FATE 835.2120 835.2240 835.2410 835.4100 835.4400 835.4300 835.1240 835.1410 835.6100 835.6200 860.1850 161-1 161-2 161-3 162-1 162-3 162-4 163-1 163-2 164-1 164-2 165-1 Hydrolysis Photodegradation - Water Photodegradation - Soil Aerobic Soil Metabolism Anaerobic Aquatic Metabolism Aerobic Aquatic Metabolism Leaching/Adsorption/Desorption Laboratory Volatilization Terrestrial Field Dissipation Aquatic Sediment Field Dissipation Study Confined Rotational Crop A,B, C,K A,B,C,K A, B, C,K A,B,C,K A,B, C,K A,B, C,K A,B, C,K A, B, C,K A,B,C,K A,B, C,K A, B, C,K 42665301 42928101 43225801 41586001, Data Gap (MCPA EHE) 40461901 4055801,4 4239601, 44732401 4259603, Data Gap (MCPA EHE) Data Gap (MCPA Acid) 42134201, 43883001, 43697501, 44026801, 42133901 Data Gap (MCPA Acid) 40961301 RESIDUE CHEMISTRY 860.1300 171-4A 17WA2 17WA3 Nature of Residue - Plants Nature of Livestock A, B, C,K A,B, C,K A,B, C,K 43575501, 41633, 53734, 43580301 5004272,00041633,43580301 43575501, 43575901, 43915401 154 ------- Appendix B Data Supporting Guideline Requirements for the Reregistration of MCPA REQUIREMENT 860.1300 860.1340 860.1380 860.1500 860.1540 860.1850 171-4B 171-4C 171-4E 171-4K 171-5 165-1 Nature of Residue - Livestock Residue Analytical Method - Plants Storage Stability - Plants Crop Field Trials (Peas) Anticipated Residues Confined Accumulation inl Rotational Crops Use Patterns A B C K A,B, C,K A,B,C,K A,B, C,K A,B, C,K A,B, C,K CITATION(S) 45288701, 43575901, 43575501, 43915401, 5575, 4724,4787, 4822,4492, 4627, 4764, 4766, 45288701, 45288701, 4449, 4766 45288712, 45288707, 45288713, 45288712, 45763101, 45288701, 4624,4625, 4491,4993, 43793901, 45288703, 45288708, 4288709, 45288705, 43756401, 45288706, 1 10363, 5567, 43718401, 43724301, 43724401, 43804601, 45288708, 45763101, 45763102, 45288709, 45288711, 45288702, 45288703, 45288705, 45288708, 45288709, 45288704, 45288712, 45763101, 45763102, 45763103, 45763104, 45763105, 45763106, 45288706 Data Gap (MCPA Acid) Ruminant Feed Study 45288710, 45288711, 102704,4491, 4651, 4491, 4443, 4453, 4473, 78931, 4993, 4655, 4659, 25394 ,45288702, 45288703, 45288705, 45288708, 45288709, 102704, 43724301, 43826402, 43724301, 43804601, 45288712, 43764101, 45763101, 45763102, 45763103, 45763104, 45763105, 43724401, 43782401, 43826401, 43826402, 45288710, 45288711, 45763101, 45763102, 45763103, 45763104, 4576105, 45288704, 45288706, 45288710, 4528871 1, 45288713 Data Gap (need modified method) Data Gap (MCPA Acid) Data Gap (MCPA Acid) 4438 40961301 155 ------- P5 * "g a g L- O, 2£ 5 s ft 3 t/3 ft g M -g 1 O S 5 S M R " g 860.1900 165-2 Field Accumulation in Rotational Crop Study P A,B, C,K H H Data Gap (MCPA Acid) OTHER 156 ------- Appendix C. Technical Support Documents Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm. The docket initially contained preliminary risk assessments and related documents as of August 10, 1998. Sixty days later the first public comment period closed. The EPA then considered comments, revised the risk assessment, and added the formal "Response to Comments" document and the revised risk assessment to the docket on June 16, 1999. All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet at the following site: www.epa.gov/pesticides/reregistration These documents include: HED Documents: 1. MCPA: Availability of Risk Assessments. 23-June-2004. 2. MCPA: Summary. 18-June-2004. 3. MCPA: Overview of Risk Assessment. 18-June-2004. 4. MCPA: Revised Human Health Risk Assessment for the RED document. 04-Jun-2004. 5. MCPA: Revised Product and Residue Chemistry Chapter for the Reregistration Eligibility Decision. 03-Jun-2004. 6. MCPA: HED Response to Comments Submitted During 30- Day Registrant Error Correction period. 04-Jun-2004. 7. MCPA: Revised MCPA Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Document. 02-Jun-2004. 8. MCPA: Revised Occupational & Residential Exposure Risk Assessment for the Reregistration Eligibility Document. 1 l-Jun-2004. 9. MCPA: Appendix A Standard Formula Used for Calculating Occupational & Residential Exposures to MCPA. 08-Jun-2004. 10. MCPA: Appendix B Occupational Handler Exposure Data and Risk Calculations for MCPA. 08-Jun-2004. 11. MCPA: Appendix C Occupational Post Application Risks of MCPA Exposures. 08-Jun-2004. 12. MCPA: Appendix D Residential Handler Exposure Data and Risk Calculations for MCPA. 08-Jun-2004. 13. MCPA: Appendix E MCPA Turf Transferable Residue Data. 08-Jun-2004. 14. MCPA: Appendix F Residential Turf Post Application Risk Assessment for MCPA. 08-Jun-2004. 157 ------- 15. MCPA: Corrected First Report of the Hazard Identification Assessment Review Committee. 29-Oct-2003. 16. MCPA: Toxicology Chapter for RED. Ol-Jul-2003. 17. MCPA: Meeting Summary, August 4, 2004. 04-Aug-2004. 18. MCPA: Availability of Reregistration Eligibility Decision Document for Comment. 24-Nov-2004. 19. MCPA: RED Fact Sheet. 29-Oct-2004. 20. MCPA: Reregistration Eligibility Decision for MCPA. 30-Sept-2004. 21. MCPA: Corrected Revised Human Health Risk Assessment for the Reregistration Eligibility Decision Document (RED). 14-Sep-2004. 22. MCPA: Second Revised Occupational and Residential Exposure and Risk Assessment for the Reregistration Eligibility Decision Document (RED). 07-Sep-2004. 23. MCPA: Appendix A. Standard Formulas Used for Calculating Occupational and Residential Exposures to MCPA. 07-Sept-2004. 24. MCPA: Appendix B, Occupational Handler Exposure Data and Risk Calculations for MCPA. 07-Sep-2004. 25. MCPA: Appendix B, MCPA Short term MOEs for Handlers. 07-Sep-2004. 26. MCPA: Appendix C, Occupational Post-Application Risks of MCPA Exposures. 07-Sep-2004. 27. MCPA: Appendix D, Residential Handler Exposure Data and Risk Calculations for MCPA. 07-Sept-2004. 28. MCPA: Appendix E, MCPA Turf Transferable Residue (TTR) Data. 07-Sep-2004. 29. MCPA: Appendix F, Residential Turf Post Application Risk Assessment for MCPA. 07-Sep-2004. 30. MCPA: Revised MCPA Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision. 15-Sep-2004. 31. MCPA: Revised Product and Residue Chemistry Chapters for the Reregistration Eligibility Decision. 14-Sep-2004. 32. MCPA: Residues of Concern. 07-Oct-2004. 33. MCPA: 4-chloro-2-Methylphenoxy Acetic acid (MCPA). 06-Oct-2004. 34. MCPA: Evaluation of Revised Application Rates and Dietary Consumption for the 2-methyl-4chlorophenoxyacetic acid (MCPA) Reregistration Eligibility Decision Document. 21-Sep-2004. EFED Documents 1. MCPA: Response to comments made by MCPA Task Force Three on EFED'S RED Chapter. 14-Apr-2004. 2. MCPA: Revised Environmental Fate and Effects Division Preliminary Risk Assessment for the 2-methyl-4chlorophenoxyacetic acid (MCPA) Reregistration Eligibility Decision Document. 14-Apr-2004. 158 ------- 3. MCPA: Environmental Rate and Effects Division's Risk Assessment for the Reregistration Eligibility Document for 2-methyl-4chlorophenoxyacetic acid (MCPA). Ol-Jun-2004. 159 ------- APPENDIX D: BIBLIOGRAPHY MCPA General References: Anderson, A.M, Byrtus, G., Thompson L, Humphries, D., Hill, B., and Bilyk, M., 2002. Baseline Pesticide Data for Semi-Permanent Wetlands in the Aspen Parkland of Alberta. Alberta Environment, Publication No. T/673. Blomquist, J.D., 2003. Personal Communication. Blomquist, J.D., Denis, J.M., Cowles, J.L., Hetrick, J.A., Jones, R.D., and Birchfield, N.B. 2001. Pesticides in Selected Water-Supply Reservoirs and Finished Drinking Water 1999-2000: Summary of Results from a Pilot Monitoring Program. USGS Open-File Report 01-456. Baltimore, Maryland 2001. Dubberly, Dale., Florida Department of Agriculture and Consumer Services (FDOACS), 2003. Personal Communication. ECOFRAM. 1999. ECOFRAM Terrestrial Draft Report. Ecological Committee on FIFRA Risk Assessment Methods. USEPA, Washington, DC. Fletcher, J.S., I.E. Nellsen, and T.G. Pfleeger. 1994. Literature review and evaluation of the EPA food- chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Env. Toxicol. Chem. 13:1381-1391. Feitshans, T.A., 1999. An Analysis of State Pesticide Drift Laws, San Joaquin Agric. L. Rev. 1, 37 (Spring 1999). Furlong, E.T., Anderson, B.D., Werner, S.L., Soliven, P.P., Coffey, L.J., and Burkhardt, M.R., 2001. Methods of Analysis by the U.S. Geological Survey National Water Quality Laboratory - Determination of Pesticides in Water by Graphitized Carbon-Based Solid-Phase Extraction and High-Performance Liquid Chromotography/Mass Spectormetry. USGS Water-Resources Investigations Report 01-4134. Denver, Colorado, 2001. 160 ------- Gibson, L. R. and M. Liebman. 2002. Course Material for Principles of Weed Science, Agronomy 317, Iowa State University. Website accessed 15 July 2003, http://www.agron.iastate.edu/courses/Agron317/Herbicide_mode_of_action.htm. Harrison, S.A., Watschke, T.L., Mumma, R.O., Jarrett, A.R., and Hamilton, G.W. Jr. 1993. Nutrient and pesticide concentrations in water from chemically treated turfgrass. In K. Racke and A. Leslie (editors), Pesticides in urban environments: Fate and significance. American Chemical Society (ACS) Symposium Series 1993, #522, p. 191-207. Hoerger, F. and E. E. Kenaga. 1972. Pesticide residues on plants: correlation of representative data as a basis for estimation of their magnitude in the environment, in. F. Coulston and F. Corte (editors), Environmental Quality and Safety: Chemistry, Toxicology, and Technology. Vol I. Georg Thieme Publishers, Stuttgart, West Germany, pp. 9-28. Jones, R. D., Breithaupt, J., Carleton, J., Libelo, L., Lin, J., Matzner. R., Parker, R., and Birchfield, N. Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessments, November 16, 1999. United States Environmental Protection Agency (USEPA) Office of Pesticide Programs (OPP). Kellogg, R.L., Wallace, S., Alt, K., and Goss, D.W. 1998. Potential Priority Watersheds for Protection of Water Quality from Nonpoint Sources Related to Agriculture. United States Department of Agriculture, Natural Resources Conservation Service (NRCS). Majewski, M.S. and Capel, P.D. 1995. Pesticides in the Atmosphere: Distribution, Trends, and Governing Factors. USGS Series: Pesticides in the Hydrologic System, Volume One in the Series. Ann Arbor, Michigan. Mayer, F. L. and M.R. Ellersieck. 1986. Manual of acute toxicity: Interpretation and data base for 410 chemicals and 66 species of freshwater animals. United States Department of the Interior, U.S. Fish and Wildlife Service, Resource Publication 160. Mineau, P., B. T. Collins, and A. Baril. 1996. On the use of scaling factors to improve interspecies extrapolation of acute toxicity in birds. Regulatory Toxicology and Pharmacology. 24:24-29. Nagy, K. A. 1987. Field metabolic rate and food requirement scaling in mammals and birds. Ecological Monographs 57:111-128. Paris, D.F., Steen, W.C., Baughman, G.L., and Barrnett, J.T. Jr, 1981. Second-Order Model to Predict Microbial Degradation of Organic Compounds in Natural Waters. Applied and Environmental Microbiology, vol. 41, No. 3, p 603-609. 161 ------- Paris, D.F., Wolfe, N.L., and Steen, W.C., 1983. Microbial Transformations of Esters of Chlorinated Carboxylic Acids. Applied and Environmental Microbiology, vol. 47, No. 1, p 7-11. Rawn, D.F.K., Halldorson, T.H.J., Lawson, B.D., and Muir, C.G., 1999. A Multi-Year Study of Four Herbicides in Air and Precipitation from a Small Prairie Watershed. J. Environ. Qual. 28:898- 906. Smith, A.E. and Hayden B.J., 1980. Hydrolysis of MCPA Esters and the Persistence of MCPA in Saskatchewan Soils. Bull. Environm. Contam. Toxicol., 25, 369-373. Steen, W.C. 1991. Microbial Transformation Rate Constants of Structurally Diverse Man-made Chemicals. U.S. Environmental Protection Agency, Athens GA. EPA/600/3-91/016. Swarzenbach, R.P., Gschwend, P.M., and Imboden, D.M., 1993. Environmental Organic Chemistry. John Wiley and Sons, Inc. New York. Thelin, G.P. and Gianessi, L.P. 2000. Method for Estimating Pesticide Use for County Areas of the Conterminous United States. USGS Open-File Report 00-250, Sacramento, California 2000. USEPA, 2002. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides Input Parameter Guidance. Version U February 28, 2002. U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Division. USEPA. 1993. Wildlife Exposure Factors Handbook. Office of Research and Development, Washington, D.C. EPA/600/R-93/187. December 1993. USEPA, 1999. Applying a Percent Crop Area Adjustment to Tier 2 Surface Water Model Estimates for Pesticide Drinking Water Exposure Assessments. U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Division. USEPA, 1992. Pesticides in Ground Water Database: A Compilation Of Monitoring Studies: 1971- 1991, National Summary. EPA 734-12-92-001. Washington, D.C. September 1992. Wolfe, N.L. 1990. Abiotic Transformations of Toxic Organic Chemicals in the Liquid Phase and Sediments. In: Toxic Organic Chemicals in Porous Media. Z. Gerstl, Y. Chen, U. Mingelgrin and B. Yaron. (Eds.). Springer-Verlag, New York. p. 136-147. Wolfe, N.L., M.E-S. Metwally and A.E. Moftah. 1989. Hydrolytic Transformations of Organic Chemicals in the Environment. In: Reactions and Movement of Organic Chemicals in Soils. B.L. 162 ------- Sawhney and K. Brown, (Eds), Soil Science Society of America and American Society of Agronomy, Madison, WI. p. 229-242. PC Code 030501: 1 MRID Citation Reference 4438 Miller. P.W.: Jensen. D.J. (1973^ Study of Alkaline Hydrolysis for Determination of Residues of MCPA and 2-Methvl-4-chlorophenol in Milk: Report No. GH-C 628. Method dated Feb 13. 1973. (Unpublished study received on unknown date under 9F0761: submitted bv Dow Chemical U.S.A.. Midland. Mich.: CDL:092000-C) 4443 Thornburg. W. (1973^ MCPA Residues in Peas: A Summary of Residue Data. (Unpublished study received on unknown date under 9F0761: prepared by Del Monte Corp.. submitted bv Dow Chemical U.S.A.. Midland. Mich.: CDL:092000- a 4453 Winterlin. M.: Radosivich. S.R. (1974) Report of Analysis: Environ- mental Toxicology Report No. 3445. Includes undated method. (Unpublished study received Feb 10. 1976 under 6E1746: prepared by Univ. of California—Davis. Dept. of Environmental Toxicology, submitted by Interregional Research Project No. 4. New Brunswick. N.J.: CDL:095368-C) 4473 Frost K.R.. Jr. (1966} Weed Control Headlines 1965-1966. (Unpublished study received Nov 6. 1967 under 464-398: prepared by South Dakota State Univ.. submitted bv Dow Chemical U.S.A.. Midland. Mich.: CDL:003622-R) 4491 Herman. J.L.: Bierke. E.L.: Getzendaner. M.E. (1970) Residue of 2-Methyl-4- chlorophenoxyacetic acid and 2-Methyl-4-chlorophenol in Milk and Cream from Cows Fed MCPA. (Unpublished study received Jan 11. 1971 under 9F0761: prepared by Dow Chemical Co.. submitted by National Agricultural Chemicals Association. Indus- try Task Force on Phenoxy Herbicide Tolerances. Washington. D.C.:CDL:091313-r> 4492 Herman. J.L.: Bjerke. E.L. (1970) Determination of MCPA and 2-Methyl-4- chlorophenol in Milk and Cream by Gas Chromatography. Method no. ACR 70.17 dated Dec 2. 1970. (Unpublished study received Jan 11. 1971 under 9F0761: prepared by Dow Chemical Co.. submitted by National Agricultural Chemicals Association. Industry Task Force on Phenoxy Herbicide Tolerances. Washington. D.C.:CDL:091313-D 4493 Amchem Products. Incorporated (1968} Summary of Performance Data: Brominal 163 ------- Plus). Summary of studies 002199-B through 002199-P. (Unpublished study received Oct 30. 1968 under 264-239: submitted by Union Carbide Agricultural Products Co.. Ambler. Pa.: CDL:002199-A) 4624 Herman. J.L.: Bierke. E.L.: Getzendaner. M.E. (1971) Residues of 2-Methvl-4- chlorophenoxyacetic acid and 2-Methyl-4-chlorophenol in Milk and Cream from Cows Fed MCPA. (Unpublished study received Oct 11. 1971 under 9F0761: prepared by Dow Chemical Co.. submitted by National Agricultural Chemicals Association. Indus- try Task Force on Phenoxy Herbicide Tolerances. Washington. D.C.:CDL:091311-E^ 4625 Bjerke. E.L.: Herman. J.L. (1971) Residues of 2-Methyl-4-chloro- phenoxyacetic acid and 2-Methyl-4-chlorophenol in Tissues of Beef Calves Fed MCPA. (Unpublished study received Oct 11. 1971 under 9F0761: prepared by Dow Chemical Co.. submitted by Nation- al Agricultural Chemicals Association. Industry Task Force on Phenoxy Herbicide Tolerances. Washington. D.C.: CDL:091311-F) 4626 Bjerke. E.L.: Herman. J.L. (1971^ Residues of 2-Methyl-4-chloro- phenoxyacetic acid and 2-Methyl-4-chlorophenol in Tissues of Sheep Fed MCPA. (Unpublished study received Oct 11. 1971 under 9F0761: prepared by Dow Chemical Co.. submitted by National Agricultural Chemicals Association. Industry Task Force on Phenoxv Herbicide Tolerances. Washington. D.C.: CDL:091311-G) 4651 Higham. J.W.: Feenv. R.W. (1974) AvengeA(IOI (CL 84.777^: Determination of MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Wheat Grain and Straw Following Ground. Postemergence Applica- tion in Combination with Avenge (1.2- Dimethyl-3.5-diphenyl pyra- zolium methyl sulfate). (Oregon): Report No. C-576. (Unpublished study received Nov 14. 1975 under 6F1703: prepared in cooperation with State Univ. of New York—Oswego. Lake Ontario Environmental Laboratories. submitted by American Cyanamid Co.. Princeton. N.J.: CDL:094738-Y^ 4655 Elenewski. C.A.: Wang. T. (1975) AvengeAflOI (CL 84.777s): Determination of CL 84.777 (1.2-Dimethyl-3.5-diphenyl-lH-pyrazolium methyl sulfate). Bromoxynil (3.5- Dibromo-4-hydroxylbenzonitrile^ and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Durum Wheat Grain and Straw Following Aerial Application of Avenge Alone and in Combination with MCPA or Bromoxynil. (Minnesota): Report No. C-823. (Unpublished study received Nov 14. 1975 un- der 6F1703: prepared in cooperation with Biodynamics. Inc.. submitted by American Cyanamid Co.. Princeton. N.J.: CDL:094738-AID 4659 Elenewski. C.A.: Wang. T. (1975) AvengeA(R)I TCL 84.777): Determination of CL 84.777 (1.2-Dimethvl-3.5-diphenvl-lH-pyrazolium methyl sulfate). Bromoxvnil (3.5- 164 ------- Dibromo-4-hydroxylbenzonitrile) and MCPA (2-Methyl-4-chlorophenoxyacetic acid^ Residues in Wheat Grain and Straw Following Ground Application of Avenge Alone and in combination with MCPA or Bromoxynil. (Oregon): Report No. C- 820. (Unpublished study received Nov 14. 1975 under 6F1703: prepared in cooperation with Biodynamics. Inc.. submitted by American Cyanamid Co.. Princeton. N.J.: CDL:094738-AH) 4724 St. John. L.E.. Jr. (1967} MCPA. Pages 445-454. In Analytical Methods for Pesticides. Growth Regulators and Food Additives: Volume 5. Edited by G. Zweig. New York: Academic Press. (Also in unpublished submission received Sep 12. 1968 under 8F0676: submitted bv Dow Chemical U.S.A.. Midland. Mich.: CDL:092980-AP^ 4787 Guardigli. A. (1974^ Rhodia Analytical Method No. 123. Includes two methods dated March 1974. (Unpublished study received Jan 30. 1976 under 359-534: prepared by Rhodia. Inc.. submitted by Rhone-Poulenc. Inc.. Monmouth Junction. N.J.: CDL:222737-A^ 4822 Guvton. C.L. (1977) Procedures for the Measurement of Asulam. MCPA. Sulfanilamide and Acetylasulam in/on Flax: Forages. Straw. Seed and Mill- Processed Flax Seed Fractions. Method no. 143 dated Jul 1977. (Unpublished study received Apr 13. 1979 under 359- 662: prepared by Rhodia. Inc.. submitted bv Rhone-Poulenc. Inc.. Monmouth Junction. N.J.: CDL:238025-BN) 4993 IR-4 Project at Rutgers, the State University (1974} MCPA-Sorghum Residue Studies. (Unpublished study received Oct 3. 1975 under 6E1681: CDL:097351-AN) 5575 Montgomery. M.L. (1970} MCPA Residue in Wheat: Oregon State University Report. Includes methods dated Jun 17. 1970 and Apr 1. 1970. (Unpublished study including summary report and letters dated Apr 2. 1970 from M.L. Montgomery to Don T. Lillie and J.A. Ignatoski. received Jan 22. 1971 under 9F0761: prepared by Ore- gon State Univ.. Dept. of Agricultural Chemistry, submitted by National Agricultural Chemicals Association. Industry Task Force on Phenoxy Herbicide Tolerances. Washington. D.C.: CDL:091308-D 21972 Raltech Scientific Services. Incorporated (1979} Oral Defined LD50. (Unpublished study received Jul 16. 1979 under 39335-1: submit- ted by Fallek-Lankro Corp.. Tuscaloosa. Ala.: CDL:238870-B^ 25394 Rvdrich. P.: Wallace. K.: Beck. B.: et al. (1976^ Residue Results: Banvel plus Bromoxynil plus MCPA Tank Mix: Summary. (Unpub- lished study received Feb 18. 1976 under 876-25: prepared in co- operation with Oregon State Univ.. submitted bv Velsicol Chemi- cal Corp.. Chicago, ni.: CDL:225197-Q 165 ------- 41633 46148 53734 61368 78931 102704 106595 15682 Keller. W.: Otto. S. (1979) Investigations into the Metabolism of MCPA in Winter Wheat: Report No. 161 la. (Unpublished study including submitter summary. received Aug 28. 1980 under 2217'-EX- 2: prepared by BASF. AG. submitted by FBI-Gordon Corp.. Kansas City. Kans.: CDL:243167-A) Interregional Research Project Number 4 (1980^ Summary of Residue Data for MCPA in or on Forage Legumes Seeded with Small Grains. Includes two undated methods entitled: Analysis of 2-Methyl-4- chlorophenoxyacetic acid from oats and alfalfa: 2-Methyl-4- chlorophenol on oats and alfalfa. (Unpublished study received Nov 5. 1980 under 6E1856: CDL:099690-A^ Akzo Zout Chemie Nederland. B.V. (1975^ MCPA: Some Information on Properties. Applications. Stability and Toxicity. Summary of studies 231352-B through 231352-D. 231352-N. 231352-O. 231352-O through 231352-T. 231355-D. 231355-F through 231355-K. 231355-M through 231355-R. 231355- U. 231355-Y and 231355-Z. (Unpublished study received Aug 15. 1977 under 38117-3: CDL:231355-A) Reuzel. P.G.J.: van der Heijden. C.A.: van Oostrum. E.C.M. (1978^ Range-Finding (4-Week) Toxicity Study with MCPA in Beagle Dogs: Report No. R 5369. Final rept. (Unpublished study received Nov 3. 1980 under 2217-EX-2: prepared by Centraal Instituut voor Voedingsonderzoek. TNO. submitted by FBI-Gordon Corp.. Kansas City. Kans.: CDL:243634-A. 243633} Rohm & Haas Company (1978^ Treatment and MCPA Residue Summary for Barlev & Oats. (Unpublished study received Jul 14. 1981 under 707-75: CDL:070183-B^ National Agricultural Chemicals Assoc. (1973^ The Results of Tests on the Amount of Residue Remaining. Including a Description of the Analytical Method Used: (2.4- D). (Compilation: unpublished study received Sep 7. 1973 under 8F0670: CDL:092143-AN) Reuzel. P.: Hendriksen. C: Feron. V.: et al. (1980) Subchronic (13-week) Oral Toxicity Study of MCPA in Beagle Dogs: Report No. R 6478. Final rept. (Unpublished study received Jul 6. 1982 under unknown admin, no.: prepared by Centraal Instituut Voor Voedingsonderzoek. TNO. Neth.. submitted by Diamond Shamrock Agricultural Chemicals. Cleveland. OH: CDL:247854-A: 247855: 247856;) Bach. K. (1974) Acute Oral Toxicity in Rats of Weedar MCPA Concentrate: Contract No. 121-2320-54. Final rent. (Unpublished study received Oct 18. 1982 166 ------- under 264-47: prepared by Affiliated Medical Research. Inc.. submitted by Union Carbide Agricultural Products Co.. Inc.. Research Triangle Park. NC: CDL:248567-C) 148720 Engelhardt. G. (1985^ Cytogenetic Investigations in Chinese Hamsters after a Single Oral Administration of MCPA: [(4-Chloro- 2-methylphenoxy Acetic Acid)]: Sister Chromatid Exchange (SCEY Project No. 16M0046/8356: Supplementary Study. Unpublished study prepared by BASF AG. 32 p. 155099 BASF Wyandotte Chemical Co. (1985) Product-specific Data Require- ments for MCPA Manufacturing Use Products. Unpublished com- pilation. 33 p. 155743 Gilmore. Inc. (1985) [Product Chemistry Data for MCPA Technical Acid]. Unpublished study. 84 p. 158077 A. H. Marks & Co.. Ltd. (19??) Manufacturing Process for MCPA Technical Acid. Unpublished compilation. 10 p. 158078 A. H. Marks & Co.. Ltd. (19??) Analysis and Certification of Product Ingredients [of MCPA]. Unpublished study. 2 p. 159470 Rhone-Poulenc Inc. (1986) Product Chemistry Data Requirements under EPA Pesticide Assessment Guidelines Dated Oct. 1982: 2(-4- Chloro-2-methylphenoxy) Acetic Acid. MCPA Tech.: ECD/JBU/LMC/ 2108. Unpublished compilation. 136 164352 Hellwig (1986) Report on the Study of the Toxicitv of MCPA in Beagle Dogs after 12-month Administration in the Diet: Project No. 33D0046/8341. Unpublished study prepared by BASF Institute. 691 p. 165470 Kirsch. P. (1985) Report on the Study of the Toxicitv of MCPA in Mice after 4- weeks Administration in the Diet (Range-finding Study): [To Determine Dosage for a 78-week Oncogenicitv Study]: Project No. 50S0046/8342. Unpublished study prepared by BASF Ag. 177 p. 165471 Kirsch. P. (1985) Report on the Study of the Toxiciry of MCPA in Rats after 3 Months Administration in the Diet: [Range-finding Study for 2-year Oncogenicitv Study in Rats]: Project No. 31S0046/8302. Unpublished study prepared bv BASF Ag. 381 p. 167 ------- 250090 Wolfe, G.; Shults, S.; Killeen, J.; et al. (1982) Acute Dermal Toxicity Study in (128268) Albino Rabbits with 2-Methyl-4-chlorophenoxyacetic Acid (MCPA): Report Document No. 520-5TX-81-0158-002. Primary Dermal and Eye Irritation Study in Albino Rabbits with 2-Methyl-4-chlorophenoxyacetic Acid (MCPA): Report Document No. 520-5TX-81-0160-002. Primary Oral Toxicity (LD50) Study in Rats with 2-Methyl-4-chlorophenoxyacetic Acid (MCPA): Report Document No. 520- TX-81-0157-002. (Un- published study received May 2, 1983 under 39335-4; prepared in cooperation with Hazleton Laboratories America, Inc., submitted by Diamond Shamrock Agricultural Chemicals, Tuscaloosa, AL; CDL: 250090-A) 5003259 Bjerke, E.L.; Herman, J.L.; Miller, P.W.; Wetters, J.H. (1972) Residue study of phenoxy herbicides in milk and cream. Journal of Agricultural and Food Chemistry 20(5):963-967. 40019201 Grimes, J. (1986) MCPA Acid: An Acute Oral Toxicity Study with the Bobwhite: Final Report: Wildlife International Ltd. Project No. 222-101. Unpublished study prepared by Wildlife International Ltd. 19 p. 40027501 Gelbke, H.; Engelhardt, G. (1986) Cytogenetic Investigations in Chinese Hamsters after a Single Oral Administration of MCPA: Bone Marrow Chromosomes Analysis: Project No. 10M0046/8367. Un- published study prepared by BASF Aktiengesellschaft. 55 p. 40041701 MacKenzie, K. (1986) Two-Generation Reproduction Study with MCPA in Rats: Final Report: Study No. 6148-100. Unpublished study pre- pared by Hazleton Laboratories America, Inc. 1304 p. 40053101 Klimisch, H. (1986) Acute Inhalation Toxicity LC50 4 Hours (Rat) Dust Aerosol Study of MCPA: Project No. 1310046/83. Unpublished study prepared by BASF Aktiengesellschaft. 19 p. 40461901 Obrist, J. (1987) Anaerobic Aquatic Metabolism of MCPA: Laboratory Project ID: HLA 6015-325. Unpublished study prepared by Hazle- ton Laboratories America, Inc. 75 p. 40470101 May & Baker Ltd. (1987) Addendum to Product Chemistry Data Requirements Under EPA Pesticide Assessment Guidelines ...: 2-(4-chlo- ro-2- methylphenoxy)acetic Acid, MCPA Technical: Lab. Proj. ID ECD/JBU/LMC/2108. Unpublished study. 32 p. 40471801 Bailey, R; Hopkins, D. (1987) 2-Methyl-4-chlorophenoxyacetic Acid: Determination of Octanol/Water Partition Coefficient: Lab. Proj. ID ES-DR-0004- 9672-4. Unpublished study prepared by Dow Chemi- cal Co. 13 p. 168 ------- 40471802 Hopkins, D. (1987) 2-Methyl-4-Chlorophenoxyacetic Acid: Determination of the Water Solubility: Lab. Proj. ID ES-DR-0004-9672-3. Unpublished study prepared by Dow Chemical Co. 14 p. 40471803 Chakrabarti, A.; LaBean, M. (1985) Vapor Pressure of MCPA and Two MCPA Esters: Lab. Proj. ID ML-AL-85-40005. Unpublished study prepared by Dow Chemical Co. 13 p. 40555801 Goodwin, P.; Laskowski, D. (1988) An Adsorption Study of MCPA: Project No. GH-C 1995. Unpublished study prepared by Dow Chemical Co. U.S.A. 51 p. 40634101 Kirsch, P. (1986) Report: Study on the Chronic Toxicity and Oncogenic Potential of MCPA in Rats: Final Report: Project No. 71S0046/8345. Unpublished study prepared by BASF Ag. 2026 p. 40792301 Kuhborth, B. (1986) Report: Study on the Oncogenic Potential of MCPA in Mice: Project No. 80S0046/8358. Unpublished study prepared by BASF AG. 1067 p. 40961301 Ewing, D. (1988) MCPA Confined Accumulation Study on Rotational Crops: Proj. ID PAL-EF-86-31. Unpublished study prepared by Analytical Development Corp. 149 p. 41193401 Unsworth, J. (1985) Product Chemistry Data Requirements Under EPA Pesticide Assessment Guidelines ... 2-(4-Chloro-2-methylphenoxy) Acetic Acid MCPA Technical: Proj. ID ECD/KBU/LMC/2108. Unpublished compilation prepared by Rhone-Poulenc Ltd. 75 p. 41586001 Matt, F. (1990) Aerobic and Aerobic/Anaerobic Soil Metabolism of 14 C|-MCPA: Lab Project Number: HLA 6237-107. Unpublished study prepared by Hazleton Labs America, Inc. 120 p. 41759403 Buddie, G (1990) 4-Chloro-2-Methylphenoxyacetic acid 2-Ethylhexyl Ester: Product Identity and Composition: Lab Project Number: P- 90-275. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 29 p. 42079400 Akzo Salt and Basic Chemicals BV (1991) Submission of Data to Support the Reregistration Standard for Phenoxy Herbicides (MCPA): Product Chemistry Data. Transmittal of 4 Studies. 42079401 Rausch, L. (1991) Product Chemistry for MCPA. Unpublished study prepared by Akzo Chemicals Inc. 72 p. 42079402 Bicking, M. (1991) Preliminary Analysis of MCPA Technical Acid: Lab.Project Number: 61-91-ACC.15. Unpublished study prepared by Twin City Testing Corp. 169 ------- 57 p. 42079403 Rausch, L. (1991) Product Chemistry for MCPA. Unpublished study prepared by Akzo Chemicals Inc. 13 p. 42079404 Bicking, M. (1991) Determination of Seven Product Chemistry Parameters for MCPA Technical Acid: Lab Project Number: 53-91-ACC.7. Unpublished study prepared by Twin City Testing Corp. 49 p. 42134001 Silvoy, J. (1991) LX143-04 (MCP Ester): Field Dissipation-Terrestrial-on Small Grains in California: Lab Project Number: 6237- 118C: 1641-88-43-04-06K-04. Unpublished study prepared by Hazleton Labs America, Inc. in coop, with Research for Hire. 358 p. 42134101 Silvoy, J. (1991) LX143-04 (MCP Ester) Field Dissipation-Terrestrial on Bare Ground: Lab Project Number: 6237-118D: 1641-88-43-04- 21E-03. Unpublished study prepared by Hazleton Labs America, Inc. in coop with Northwest Agricultural Research, Inc. 369 p. 42197801 Hoxter, K.; Lynn, S. (1992) MCPA 2-EHE: An Acute Contact Toxicity Study with the Honey Bee: Lab Project Number: 222-101. Unpublished study prepared by Wildlife International Ltd. 30 p. 42377401 Pryce, A. (1992) MCPA Acid (TGAI)-Product Chemistry: Final Report: Lab Project Number: AHM/EPA/92/AP/02. Unpublished study prepared by A. H. Marks & Co. Ltd. 41 p. 42377402 Anon. (1992) Beginning Materials-Data Sheets from Suppliers: (MCPA Acid (TGAI)-Product Chemistry). Unpublished study prepared by A.H. Marks & Co. Ltd. 48 p. 42377403 A. H. Marks and Co., Ltd. (1992) Beginning Materials~A H Marks' Purchase Specifications: (MCPA Acid (TGAI)-Product Chemistry). 12 p. 42377404 A H Marks and Co., Ltd. (1992) A H Marks' Standard Analytical Methods: (MCPA Acid (TGAI)-Product Chemistry). Unpublished study. 28 p. 42377405 Pryce, A. (1992) Confirmation of Identity of Impurity Standards by GC/MS: Lab Project Number: D92/2. Unpublished study prepared by A H Marks & Co. Ltd. 25 P- 42377406 Anon. (1992) Statistical Analysis of PCOC Quality Data (Histograms). Unpublished study prepared by A H Marks & Co. Ltd. 15 p. 170 ------- 42377407 42377408 42377409 42377410 42386400 42386401 42386402 42386403 42450901 42450902 42450903 42450904 Anon. (1992) MCPA Acid (TGAI) Product Specification. Unpublished study prepared by A H Marks & Co. Ltd. 5 p. Anon. (1992) MCPA Acid (TGAI) Statistical Analysis of QC Data (3 Months to June 1992). Unpublished study prepared by A H Marks & Co. Ltd. 20 p. Welch, J. (1992) MCPA Acid (TGAI) Determination of Ash, Sodium, Chloride and Sulfate: Lab Project Number: BL4/0481. Unpublished study prepared by Butterworth Labs, Ltd. 46 p. Anon. (1992) Protocol: Sampling of MCPA: EPA 91/005. Unpublished study prepared by A H Marks & Co. Ltd. 13 p. Rhone-Poulenc Ag Comp. (1992) Submission of Product Chemistry Data in Support of Reregistration for MCPA. Transmittal of 3 studies. Snell, R. (1990) MCPA Technical: Supplemental Data for Product Chemistry Series 61: Lab Project Number: ACD/GCB/MS/8762. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 26 p. Buddie, G; Patel, P. (1991) 4-chloro-2-methylphenoxyacetic acid (MCPA) Analysis and Certification of Product Ingredients, Provision of Supplementary Analytical Method Validation: Lab Project Number: P-91-055. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 14 p. Buddie, G; Mills, E. (1990) MCPA Technical: Physical Properties: Product Chemistry Series 63-2 to 63-7: Lab Project Number: D AG. 1542. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 9 p. Alexander, B.; Dinwoodie, N; Maclean, K. (1992) Product Chemistry of MCPA- Acid Analysis: Lab Project Number: 351616: 8655. Unpublished study prepared by Inveresk Research Intl. 74 p. Dinwoodie, N. ; Maclean, K. (1992) Product Chemistry of MCPA-Acid: Colour: Lab Project Number: 351621: 8541. Unpublished study prepared by Inveresk Research Intl. 15 p. Dinwoodie, N.; Maclean, K. (1992) Product Chemistry of MCPA-Acid: Physical State: Lab Project Number: 351637: 8551. Unpublished study prepared by Inveresk Research Intl. 15 p. Dinwoodie, N.; Maclean, K. (1992) Product Chemistry of MCPA-Acid: Odour: Lab Project Number: 351642: 8552. Unpublished study prepared by Inveresk Research Intl. 15 p. 171 ------- 42450905 Dinwoodie, N.; Maclean, K. (1992) Product Chemistry of MCPA-Acid: Melting Point: Lab Project Number: 351658: 8553. Unpublished study prepared.by Inveresk Research Intl. 15 p. 42450906 Alexander, B.; Dinwoodie, N; Maclean, K. (1992) Product Chemistry of MCPA- Acid: Density: Lab Project Number: 351663: 8642. Unpublished study prepared by Inveresk Research Intl. 17 p. 42450907 Alexander, B.; Dinwoodie, N.; Maclean, K. (1992) Product Chemistry of MCPA- Acid: pH: Lab Project Number: 351679: 8675. Unpublished study prepared by Inveresk Research Intl. 17 p. 42577600 AKZO (1992) Submission of product chemistry data in support of the registration of MCPA. Transmittal of 3 studies. 42577601 Rausch, L. (1992) Product Chemistry: MCPA. Unpublished study prepared by Akzo Chemicals, Inc. 84 p. 42577602 Landvoigt, W. (1992) Product Chemistry Dioxin Analysis for MCPA. Unpublished study prepared by Chemie Linz AG. 145 p. 42577603 Rausch, L. (1992) Product Chemistry: MCPA. Unpublished study prepared by AKZO Chemicals, Inc. 173 p. 42624401 Jones, E.; Kitching, 1; Anderson, A.; et al. (1992) Ames Salmonella Typhimurium Bacterial Reverse Mutation Assay on MCPA DMAS: Lab Project Number: JEL 24/921053. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 P- 42657101 Varcoe, F. (1992) Analysis of Poly chlorinated Dibenzo-p-dioxins and and Polychlorinated Dibenzofurans in (4-Chloro-2-methylphenoxy) acetic Acid: Lab Project No. 21916. Unpublished study prepared by Triangle Labs, Inc. 1402 p. 42665301 Lai, I. (1993) Hydrolysis of (carbon 14)-MCPA Acid in Buffered Aqueous Solutions: Final Report: Lab Project Number: SC910160. Unpublished study prepared by Battelle Memorial Institute. 67 p. 42715001 Baldrick, P.; Crook, D.; Gibson, W.; et al. (1992) Twenty-one Day Dermal Toxicity Study in the Rabbit with MCPA Acid: Lab Project Number: JEL 23/921253. Unpublished study prepared by Huntingdon Research Centre Ltd. 117 p. 42723801 Hellwig, J.; Hildebrand, B. (1993) Study of the Prenatal Toxicity of MCPA-Acid in Rats after Oral Administration (Gavage): Lab Project Number: 30R0374/91096. Unpublished study prepared by BASF Aktiengesellshaft. 302 p. 172 ------- 42723802 Hellwig, J.; Hildebrand, B. (1993) Study of the Prenatal Toxicity of MCPA-Acid in Rabbits after Oral Administration (Gavage): Lab Project No. 40R0374/91095. Unpublished study prepared by BASF Aktiengesellshaft. 230 p. 42757301 Campbell, C; Dinwoodie, N. (1993) Product Chemistry of MCPA-Acid: Stability: Lab Project Number: 9076. Unpublished study prepared by Inveresk Research International. 56 p. 42840403 Jones, E.; Kitching, 1; Anderson, A.; et al. (1993) Ames Salmonella Typhimurium Bacterial Reverse Mutation Assay on MCPA Acid: Lab Project Number: JEL 26/920957. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p. 42853504 Akhurst, L.; King, 1; Anderson, A.; et al. (1993) MCPA Acid Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro: Lab Project Number: JEL 32/921190. Unpublished study prepared by Huntingdon Research Centre Ltd. 48 p. 42860101 Adams, K.; Ransome, S.; Anderson, A.; et al. (1993) Chinese Hamster Ovary/HGPRT Locus Assay: MCPA DMAS: Final Report: Lab Project Number: JEL 27/921113. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p. 42860103 Adams, K.; Kirkpatrick, D.; Godfrey, A.; et al. (1993) Chinese Hamster Ovary/HGPRT Locus Assay: MCPA Acid: Final Report: Lab Project Number: JEL 29/921115. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p. 42895701 Roberts, N. (1993) Determination of Physico-Chemical Properties of MCPA Technical Acid: Final Report: Lab Study Number 15. Unpublished study prepared by Rhone-Poulenc Chemicals Ltd. 150 p. 42928101 Concha, M.; Shepler, K. (1993) Sunlight Photodegradation of (carbon 14)-MCPA in a Buffered Aqueous Solution at pH 5 by Natural Sunlight: Lab Project Number: 410W-1: 410W. Unpublished study prepared by PTRL West, Inc. 88 p. 43062806 Douds, D. (1993) A Dermal Sensitization Study in Guinea Pigs with EH 1154 Weed and Feed: A Modified Buehler Design~3 Patch Induction: Final Report: Lab Project Number: 3229.54. Unpublished study prepared by Springborn Labs, Inc. 42 p. 43083205 Hoberg, J. (1993) MCPA Acid-Determination of Effects on Seed Germination, Seedling Emergence and Vegetative Vigor of Ten Plant Species: Final Report:_Lab Project Number: 10566.0493. 6280.610: 93-8-4888. Unpublished study prepared by Springborn Laboratories, Inc. 246 p. 173 ------- 43225801 Concha, M.; Shepler, K. (1994) Photodegradation of (carbon 14)MCPA in/on Soil by Natural Sunlight: Lab Project Number: 436W-1: 436W. Unpublished study prepared by PTRL West, Inc. 91 p. 43556801 Hellwig et. al. (1995) MCPA-2-EH-Ester - Subchronic oral toxicity study in beagle dogs - Administration in Diet. Department of Toxicology, BASF, Ludwigshafen/Rhine, FRG, Report No. 31D0385/91115, January 9, 1995. MRID 43556801. Unpublished. 43556802 Hellwig, 1; Bachmann, S.; Deckardt, K.; et al. (1995) MCPA-DMA Salt-Subchronic Oral Toxicity Study in Beagle Dogs: Administration in the Diet: Lab Project Number: 31D0385/91115. Unpublished study prepared by BASF Aktiengesellschaft. 407 p. 43562601 Mellert, W.; Deckardt, K.; Kaufmann, W.; et al. (1994) MCPA-Acid-Subchronic Oral Dietary Toxicity and Neurotoxicity Study in Wistar Rats: Lab Project Number: 50C0374/91133. Unpublished study prepared by BASF Aktiengesellschaft. 723 p. 43562602 Mellert, W.; Kaufmann, W.; Hildebrand, B. (1994) MCPA-Acid-Acute Oral Neurotoxicity Study in Wistar Rats: Lab Project Number: 20C0374/91106. Unpublished study prepared by BASF Aktiengesellschaft. 388 p. 43575501 Sabourin, P.; Koebel, D. (1995) Nature of the Residue Study of (carbon 14)-2- Methyl-4-Chlorophenoxyacetic Acid ((carbon 14)-MCPA) using Lactating Goats: Final Report: Lab Project Number: SC930051. Unpublished study prepared by Battelle Columbus Operations. 232 p. 43575901 Sabourin, P.; Morgens, J.; Koebel, D. et al. (1995) Nature of the Residue Study of (carbon 14)-2-Methyl-4-Chlorophenoxyacetic Acid ((carbon 14)-MCPA) using Egg-Laying White Leghorn Hens: Final Report: Lab Project Number: SC920100. Unpublished study prepared by Battelle Columbus Operations. 285 p. 43755201 MCPA Task Force Three (1995) Overview of Comparative Absorption, Distribution, Metabolism, and Excretion (ADME) of MCPA Acid, DMAS and 2EHE in Rats. Unpublished study. 18 p. 43755202 Jahanshahi, M.; Stow, R. (1995) (Carbon 14)-MCPA: Absorption, Distribution, Metabolism, and Excretion in the Rat: Final Report: Lab Project Number: 1149/5- 1011: 1149/5. Unpublished study prepared by Corning Hazleton (Europe). 519 p. 43915401 Lawrence, L. (1996) Nature of the Residue Study of (carbon 14)-2-Methyl-4- chlorophenoxyacetic Acid (MCPA) Using Lactating Goats: Supplemental Report for MRID #43575501: Lab Project Number: 908: 1827: SC930051. Unpublished 174 ------- study prepared by PTRL East, Inc. 37 p. 43986101 Lawson, P. (1996) Product Identity and Composition MCPA Technical. Unpublished study prepared by Akzo Nobel Chemicals, Inc. 42 p. 43986102 Lawson, P. (1994) Product Identity and Composition: MCPA Technical: Lab Project Number: 94L00693. Unpublished study prepared by BASF AG. 101 p. 44027301 King, D. (1996) Characterization of ((hydrogen-2)/(carbon-12)/(carbon- 14))MCPA: Lab Project Number: 937: 1868. Unpublished study prepared by PTRL East, Inc. 25 p. 44192701 MacGregor, J.; Markley, B. (1996) External Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as its Acid Equivalent, 4-Chloro-2-methylphenoxyacetic Acid (MCPA), and 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) in Water Samples by Gas Chromatography with Mass Selective Detection: Lab Project Number: 364C-102: QMAM94002. Unpublished study prepared by Wildlife International Ltd. 64 p. 44239601 Bashir, M. (1997) The Adsorption and Desorption of MCPA, 4-CC and 4-MCA in Soil and Sediment: Lab Project Number: CO VANCE 6698-102: CHW 6698-102. Unpublished study prepared by Covance Laboratories Inc. 120 p. 44259400 Nufarm bv (1997) Submission of Product Chemistry Data in Support of the MCPA Registration Standard. Transmittal of 1 Study. 44259401 Mahlburg, W. (1997) Analytical Methods to Verify Certified Limits for MCPA Acid: Method Validation for the Active Ingredient: Lab Project Number: 97-1 A: 61/91- ACC.15: 4416-0001.01. Unpublished study prepared by Twin Cities Testing Corp. 58 p. 44337201 King, D. (1997) Characterization of (carbon 14)MCPA, (carbon 14)MCPA 2- EHE, and (carbon 14)MCPADMAS: (Final Report): Lab Project Number: 1031: 1944. Unpublished study prepared by PTRL East, Inc. 61 p. 44337202 King, D. (1997) Characterization of 4-Chloro-2- methylphenoxyacetic Acid Ornithine Conjugate (MCPA-Orn): (Final Report): Lab Project Number: 1041: 1920. Unpublished study prepared by PTRL East, Inc. 29 p. 44337203 King, D. (1996) Characterization of MCPA Glycine Conjugate: (Final Report): Lab Project Number: 1023: 1922. Unpublished study prepared by PTRL Eastjnc. 28 p. 175 ------- 44337204 King, D. (1996) Characterization of (carbon 14)MCPA Metabolites: (Final Report): Lab Project Number: 1032: 1917. Unpublished study prepared by PTRL East, Inc. 74 p. 44394401 Petersen-Thiery, M.; Ohnsorge, U.; Liesner, M. et al. (1996) Product Chemistry: Analysis and Certification of Product Ingredients, and Validation of Analytical Methods for MCPA TGAI: Lab Project Number: 96/10117: 94/11238: 95/10013. Unpublished study prepared by BASF Corp. 159 p. 44401301 Ohnsorge, U. (1996) Product Identity and Composition, Beginning Materials and Manufacturing Process, and Discussion of the Formation of Impurities of MCPA TGAI: Lab Project Number: 96/10096: 96/10101. Unpublished study prepared by BASF Aktiengesellschaft. 211 p. 44463901 Sanson, D. (1997) Physical and Chemical Properties of EH1356 Herbicide. Unpublished study prepared by FBI/Gordon Corp. 15 p. (OPPTS 830.6303, 830.7300, 830.7000, 830.6314, 830.1550, 830.1600, 830.1620, 830.1650, 830.1670,830.1800} 44639901 Moszczynski, W. (1998) Supplement to Product Chemistry Report on MCPA TGAI: Lab Project Number: IPO 98/DN: MCPAOSCT: C/BFR0154. Unpublished study prepared by Institute of Industrial Organic Chemistry. 15 p. {OPPTS 830.1600, 830.1650, 830.1670} 44645801 Ohnsorge, U. (1998) Product Identity and Composition, Beginning Materials and Manufacturing Process, and Discussion of the Formation of Impurities of MCPA TGAI: Lab Project Number: 98/10431. Unpublished study prepared by BASF Aktiengesellschaft. 162 p. {OPPTS 830.1550, 830.1600, 830.1650, 830.1670} 44645802 Turk, W. (1998) Product Chemistry Certified Limits for MCPA TGAI: Lab Project Number: 98/10284: PCP04660: 98/10339. Unpublished study prepared by BASF Aktiengesellschaft. 60 p. {OPPTS 830.1700} 44655702 Barney, W. (1998) Determinaton of Transferable Turf Residues on Turf Treated with 2,4-D, 2,4-DP, MCPA, MCPP-p and Dicamba: Lab Project Number: BTH TFR TF 001: 98-313: 6926-103. Unpublished study prepared by Grayson Research, LCC. and Covance Laboratories Inc. 521 p. {OPPTS 875.2100} 44861801 White, L. (1999) Corrosion Characteristics of EH-1356 Herbicide: Lab Project Number: 99-011. Unpublished study prepared by FBI/Gordon Corporation. 19 p. {OPPTS 830.6320} 45001901 King, D. (1999) Characterization of (carbon-14)MCPA: Lab Project Number: 176 ------- 1308: 2071. Unpublished study prepared by MCPA Task Force Three. 31 p. 45001902 King, D. (1999) Certification of (carbon(6)-13 Ring)HMCPA MME for Use as an Analytical Reference Substance: Lab Project Number: 1362: 2072. Unpublished study prepared by MCPA Task Force Three. 30 p. 45001903 King, D. (1999) Certification of (carbon(6)-13 Ring)HMCPA for Use as an Analytical Reference Substance: Lab Project Number: 1362: 2072. Unpublished study prepared by MCPA Task Force Three. 30 p. 45001904 King, D. (1999) Characterization of (D)HMCPAMME: Lab Project Number: 1310: 2070. Unpublished study prepared by MCPA Task Force Three. 28 p. 45288701 Morrissey, M.; Eberhard, J. (2000) Independent Laboratory Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) and 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as their 4-Chloro-2-methylphenoxyacetic Acid (MCPA) Equivalent, MCPA, 4-Chloro-2-hydroxymethylphenoxyacetic Acid (FDVICPA), 4- Chloro-2-hydroxymethylphenoxyacetic Acid Glucose Conjugate (HMCPA GLU) as its FDVICPA Equivalent, and 4-Chloro-2-carboxyphenoxyacetic Acid (CCPA) in Wheat Forage, Straw, and Grain: Final Report: Lab Project Number: 6698-108: 6698-107. Unpublished study prepared by Covance Laboratories Inc. 449 p. 45288702 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Winter Wheat: Lab Project Number: GR97-267: 6698-116: 6698-107. Unpublished study prepared by Grayson Research, LLC. 519 p. (OPPTS 860.1500} 45288703 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Spring Wheat: Lab Project Number: GR97-269: 6698-107: 6698-118. Unpublished study prepared by Grayson Research, LLC. 445 p. {OPPTS 860.1500} 45288704 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Pasture Grass: Lab Project Number: GR97-273: 6698-111: QMAM94002. Unpublished study prepared by Grayson Research, LLC. 361 p. {OPPTS 860.1500} 45288705 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Wheat Underseeded with Alfalfa: Lab Project Number: GR97-258: 97258-1: 97258-2. Unpublished study prepared by Grayson Research, LLC. 392 p. {OPPPTS 860.1500} 177 ------- 45288706 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Rangeland Grass: Lab Project Number: GR97- 275: 97275: 97275-1. Unpublished study prepared by Grayson Research, LLC. 317 p. (OPPTS 860.1500} 45288707 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues in Processed Fractions of Winter Wheat Following Treatment with MCPA Dimethylamine Salt: Lab Project Number: GR97-271: 97271: 6698-107. Unpublished study prepared by Grayson Research, LLC. 485 p. {OPPTS 860.1520} 45288708 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Applications of MCPA 2-Ethylhexyl Ester to Winter Wheat: Lab Project Number: GR97-268: 97268: 6698-117. Unpublished study prepared by Grayson Research, LLC. Slip. {OPPTS 860.1500} 45288709 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Spring Wheat: Lab Project Number: GR97-270: 6698-119: 6698-107. Unpublished study prepared by Grayson Research, LLC. 464 p. {OPPTS 860.1500} 45288710 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Pasture Grass: Lab Project Number: GR97-274: 97274: 97274-1. Unpublished study prepared by Grayson Research, LLC. 368 p. {OPPTS 860.1500} 45288711 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Rangeland Grass: Lab Project Number: GR97-276: 97276: 97276-1. Unpublished study prepared by Grayson Research, LLC. 334 p. {OPPTS 860.1500} 45288712 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Wheat Underseeded with Alfalfa: Lab Project Number: G97-266: 6698-110: 6698-107. Unpublished study prepared by Grayson Research, LLC. 288 p. {OPPTS 860.1500} 45288713 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues in Processed Fractions of Winter Wheat Following Treatment with MCPA 2-Ethylhexyl Ester: Lab Project Number: GR97-272: 97272: 97272-1. Unpublished study prepared by Grayson Research, LLC. 484 p. {OPPTS 860.1520} 45549601 Eberhard, J. (2001) Final Report: Freezer Storage Stability Study for MCPA DMAS, 4-Chloro-2-hydroxymethylphenoxyacetic Acid (2-HMCPA) and 4- Chloro-2-carboxyphenoxyacetic Acid (CCPA) and MCPA 2-EHE in Selected 178 ------- Plant Matrices: Lab Project Number: 6698-122. Unpublished study prepared by Covance Laboratories Inc. 1353 p. (OPPTS 860.1380} 45595301 Hardwick, T. (1999) (Carbon-14)-MCPA: Absorption and Excretion in the Beagle Dog: Final Report: Lab Project Number: 729/197: 729/197-D1141. Unpublished study prepared by Covance Laboratories Ltd. 148 p. {OPPTS 870.7485} 45595302 Hardwick, T. (2000) (Carbon-14)-MCPA: Metabolite Profiles in the Beagle Dog: Amended Final Report: Lab Project Number: 729/201: 729/201-D1141. Unpublished study prepared by Covance Laboratories Ltd. 78 p. 45763101 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues From Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Haywood, Manitoba: Lab Project Number: GR01-394: 01-394.1: 01-394. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and ICMS, Inc. 520 p. {OPPTS 860.1500} 45763102 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Elm Creek, Manitoba: Lab Project Number: GR01-413: 01-413.1: 01-413. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 515 p. {OPPTS 860.1500} 45763103 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Barnwell, Alberta: Lab Project Number: GR01-414: 01-414.1: 01- 414. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 522 p. {OPPTS 860.1500} 45763104 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Fairview, Alberta: Lab Project Number: GR01-415: 01-415.1: 02GRY17.REP. Unpublished study prepared by Grayson Research, LLC., Enviro- Test Laboratories, Inc. and Three Links Ag Research. 502 p. {OPPTS 860.1500} 45763105 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Rosthern, Saskatchewan: Lab Project Number: GR01-416: 01- 416.1: 02GRY18.REP. Unpublished study prepared by Grayson Research, LLC., Ag Quest, Inc. and Enviro-Test Laboratories, Inc. 583 p._{OPPTS 860.1500} 45763106 MCPA Task Force Three (2002) Summary Comparison of 1998 and 2001 Magnitude of Residue Results. Unpublished study. 19 p. {OPPTS 860.1500} 179 ------- 45889301 Pigott, G. (2003) MCPA and Testicular Toxicity. Unpublished study prepared by MCPA Task Force Three. 7 p. 46276101 Mellert, W.; Deckardt, K.; Kuttler, K.; *et. al. (2004) MCPA and CCPA: Repeated Dose Toxicity Study in Wistar Rats: Administration in the Diet Over 4 Weeks. Project Number: 30C0288/03019, 01Y0288/038009, PCP02751. Unpublished study prepared by BASF Aktiengesellschaft and BASF Ag Research Station (Basf Aktieng). 329 p. 46327601 Beimborn, D.; Leibold, E. (2003) (Carbon 14)-MCPA - Study of the Dermal Absorption in Rats. Project Number: 01B0209/026003. Unpublished study prepared by BASF Aktiengesellschaft. 41 p. PC Code 030502: MRID Citation Reference 4449 Guardigli, A.; Henckler, P.M. (1973) Final Summary: MCPA and Phenol Metabolite in Pasture and/or Range Grasses. (Unpublished study received on unknown date under 9F0761; prepared by Rhodia, Inc., submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:092001-F) 5004272 Kirkwood, R.C.; Dalziel, 1; Matlib, A.; Somerville, L. (1972) The role of translocation in selectivity of herbicides with reference to MCPA and MCPB. Pesticide Science 3(3):307-321. 41613003 Robbins, G. (1990) Guinea Pig Sensitization (Buehler): Lab Project Number: F3045. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 16 p._ 41800901 Bowman, 1; Gormley, M. (1990) Acute Flow-through Toxicity of Chip- tox (MCPA Sodium Salt) to Bluegill (Lepomis macrochirus): Lab Project Number: 38520. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 190 p. 41800902 Bowman, 1; Gormley, M. (1990) Acute Flow-through Toxicity of Chip- tox (MCPA Sodium Salt) to Rainbow Trout (Oncorhynchus mykiss): Lab ProjectNumber: 38521. Unpublished study prepared by Analy- tical Bio-Chemistry Laboratories, Inc. 223 p. 41800903 Burgess, D. (1990) Acute Flow-through Toxicity of Chiptox (MCPA Sodium Salt) to Daphnia magna: Lab ProjectNumber: 38522. Un- published study prepared by Analytical Bio-Chemistry Laboratories. 187 p. 180 ------- 42133901 Silvoy, J. (1991) MCPA-NA+ Salt Formulation Field Dissipation Terr- estrial Study on Small Grains in Washington: Lab Project Number: 6237-1 ISA: 1641-88-43-03-06K- 02. Unpublished study prepared by Hazleton Labs America, Inc. in coop, with Northwest Ag. Research Inc. 347 p. PC Code 030516: MRID Citation Reference 4766 4993 5567 53734 110363 Guardigli, A.(1970) MCPA Residues in Flax Seed: Field Test Project No. STP 69- 26; 69-27. Includes method no. 104 dated Nov 25, 1969. (Unpublished study received Jan 22, 1971 under 9F0761; prepared by Rhodia, Inc. in cooperation with Univ. of Minnesota and North Dakota State Univ. of Agriculture and Applied Science, submitted by National Agricultural Chemicals Associa- tion, Industry Task Force on Phenoxy Herbicide Tolerances, Washington, D.C.; CDL:091308-O) IR-4 Project at Rutgers, the State University (1974) MCPA-Sorghum Residue Studies. (Unpublished study received Oct 3, 1975 under 6E1681; CDL:097351-A) Higham, J.W.; Feeny, R.W.; Cheston, K.G.; Snyder, E.H.; Wingfield, C.B. (1975) Avenge(R) (AC 84,777): Determination of CL 84, 777 (l,2-Dimethyl-3,5-diphenyl pyrazolium methyl sulfate), Bro- moxynil (3,5-Dibromo-4-hydroxylbenzonitrile) and MCPA (2-Methyl- 4-chlorophenoxyacetic acid) Residues in Barley Grain and Straw Following Ground Application (Colorado): Report No. C-594. (Unpublished study received Jan 8, 1975 under 241-EX-64; prepared in cooperation with Lake Ontario Environmental Laboratory, sub- mitted by American Cyanamid Co., Princeton, N.J.; CDL:224170-T) Akzo Zout Chemie Nederland, B.V. (1975) MCPA: Some Information on Properties, Applications, Stability and Toxicity. Summary of studies 231352-B through 231352-D, 231352-N, 231352-O, 231352-Q through 231352-T, 231355-D, 231355-F through 231355-K, 231355-M through 231355-R, 231355- U, 231355-Y and 231355-Z. (Unpublished study received Aug 15, 1977 under 38117-3; CDL:231355-A) American Cyanamid Co. (1974) Extent of Avenge Wild Oat Herbicide Residues and MCPA; Bromoxynil Residues in Barley Plants and Grain Resulting from Tank Mix Combinations, Including a Descrip- tion of the Analytical Methods Used. (Compilation; unpublished study received Jan 8, 1975 under 241-EX-64; CDL:095054-G) 181 ------- 40019202 Grimes, J. (1986) MCPA Dimethylamine Salt: An Acute Oral Toxicity Study with the Bobwhite: Final Report: Wildlife International Ltd. Project No. 222-102. Unpublished study prepared by Wild- life International Ltd. 19 p. 40062004 Ward, T. (1986) Static Acute Toxicity of Technical MCPA Dimethyl- amine Salt (2- Methyl-4-chlorophenoxyacetic Acid, Dimethylamine Salt) to the Bluegill, Lepomis macrochirus: Laboratory Project ID: Dl 186. Unpublished study prepared by ERCO/A Division of ENSECO Inc. 19 p. 40062006 Ward, T. (1986) Static Acute Toxicity of Technical MCPA Dimethyl- amine Salt (2- Methyl-4-chlorophenoxyacetic Acid, Dimethylamine Salt) to the Pink Shrimp. Penaeus Duorarum: ERCO Laboratory Project D0686. Unpublished study prepared by ERCO/A Division of ENSECO Inc. 19 p. 40352101 Jeffrey, M. (1987) MCP Amine Herbicide: Dermal Sensitization Poten- tial in the Hartley Albino Guinea Pig: Laboratory Project ID: DR-0229-0702-003. Unpublished study prepared by Dow Chemical Co. 13 p. 40555802 Grimes, J.; Jaber, M. (1988) MCPA Dimethylamine Salt (2-Methyl-4- chlorophenoxyacetic Acid, Dimethylamine Salt): A dietary LC50 Study with the Mallard: Proj. No. 103-285. Unpublished study prepared by Wildlife International Ltd. 26 p. 40555803 Grimes, J.; Jaber, M. (1988) MCPA Dimethylamine Salt (2-Methyl-4- chlorophenoxyacetic Acid, Dimethylamine Salt): A Dietary LC50 Study with the Bobwhite: Proj. No. 103-284. Unpublished study prepared by Wildlife International Ltd. 26 p. 41800905 Bowman, J.; Gormley, M. (1990) Acute Flow-through Toxicity of Rhomene (MCPA DMA) to Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: 38528. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 224 p. 41800906 Burgess, D. (1990) Acute Flow-Through Toxicity of Rhomene (MCPA DMA) to Daphnia magna: Lab Project Number: 38530. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 195 p. 42113103 Holbert, M. (1991) Acute Inhalation Toxicity Study in Rats: Clean Crop MCP Amine 4: Lab Project Number: 8458-91: 91-47A. Unpublished study prepared by Stillmeadow, Inc. 24 p. 42134201 Silvoy, J. (1991) MCPA-Dimethylamine Salt Field Dissipation Terrestrial Study on Pasture Grass in Donalsonville, GA: Lab Project Number: HLA 6237-118B: 1641- 182 ------- 88-43-01-18D-01. Unpublished study prepared by Hazleton Labs America, Inc., in coop, with Southern Agric. Research Inc. 346 p. 42150301 Hoxter, K.; Lynn, S. (1991) MCPA DMAS: An Acute Contact Toxicity Study with the Honey Bee: Lab Project Number: 222-102. Unpublished study prepared by Wildlife International Ltd. 29 p. 42412201 Putt, A. (1992) MCPA DMAS-Acute Toxicity to Daphnids (Daphnia magna) under Flow-through Conditions: Final Report: Lab Project Number: 92-4-4235: 10566.0391.6196.115. Unpublished study prepared by Springborn Laboratories, Inc. 60 p. 42457101 Chang, J. (1992) Special Study: Dissociation of MCPA DMAS in Water: Final Report: Lab Project Number: SC920051. Unpublished study prepared by Battelle. 40 p. 42461301 Hoberg, J. (1992) MCPA-DMAS-Toxicity to the Freshwater Green Alga, Selenastrum capricornutum: Final Report: Lab Project Number: 92-6-4285: 10566.1191.6213.430. Unpublished study prepared by Springborn Labs, Inc. 68 p. 42596903 Fernando, T. (1992) Sorption/Desorption of (carbon 14)-MCPA Acid on Soils by the Batch Equilibrium Method: Lab Project Number: SC910081. Unpublished study prepared by Bettelle Memorial Institute. 78 p. 42624401 Jones, E.; Kitching, J.; Anderson, A.; et al. (1992) Ames Salmonella Typhimurium Bacterial Reverse Mutation Assay on MCPA DMAS: Lab Project Number: JEL 24/921053. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p. 42624402 Munk, R; Kirsch, P. (1992) Acute Toxicity Study on the Bluegill (Lepomis macrochirus RAF.) of MCPA DMAS in a Static System: Lab Project Number: 14F0189/915055. Unpublished study prepared by BASF Aktiengesellschaft. 38 p. 42669304 Maggi, V. (1993) Tier II: The Effects of MCPA DMAS on Nontarget Plants: Vegetative Vigor: A Supplement: Lab Project Number: CAR 146-91C: 1147. Unpublished study prepared by California Agricultural Research, Inc. 163 p. 42698701 Maggi, V. (1993) The Effects of MCPA DMAS on Nontarget Plants: Seed Germination/Seedling Emergence: Final Report: Lab Project Number: CAR 146- 91F: 1145. Unpublished study prepared by California Agricultural Research, Inc. 299 p. 42853502 Proudlock, R.; Taylor, K.; Anderson, A.; et al. (1993) MCPA DMAS Mcronucleus Test ?in Bone marrow of Mice|: Lab Project Number: JEL 33/921197. Unpublished 183 ------- study prepared by Huntingdon Research Centre Ltd. 43 p. 42853505 Akhurst, L.; King, 1; Anderson, A.; et al. (1993) MCPA DMAS Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro: Lab Project Number: JEL 30/921176. Unpublished study prepared by Huntingdon Research Centre Ltd. 45 p. 42860101 Adams, K.; Ransome, S.; Anderson, A.; et al. (1993) Chinese Hamster Ovary/HGPRT Locus Assay: MCPA DMAS: Final Report: Lab Project Number: JEL 27/921113. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p. 43083206 Hoberg, J. (1993) MCPA-DMA Salt-Toxicity to the Marine Diatom, Skeletonema costatum: Lab Project Nos. 10566.0493.6298.450; 93-11-5029. Unpublished study prepared by Springborn Laboratories, Inc. 70 p. 43083207 Hoberg, J. (1993) MCPA-DMA Salt-Toxicity to the Freshwater Diatom, Navicula pelliculosa: Final Report: Lab Project Number: 10566.0493.6291.440: 93-6-4835. Unpublished study prepared by Springborn Laboratories, Inc. 68 p. 43083208 Hoberg, J. (1993) MCPA-DMA Salt-Toxicity to the Freshwater Blue-Green Alga, Anabaena flos-aquae: Final Report: Lab Project Number: 10566.0493.6295.420: 93-6-4841. Unpublished study prepared by Springborn Laboratories, Inc. 66 p. 43083210 Bettencourt, M. (1993) MCPA-DMA Salt-Acute Toxicity to Sheepshead Minnow (Cyrinodon variegatus) under Flow-through Conditions: Final Report: Lab Project Number: 10566.0493.6276. 505: 93-7-4859. Unpublished study prepared by Springborn Laboratories, Inc. 73 p. 43126502 Hoberg, J. (1994) MCPA-DMA Salt: Toxicity to Duckweed, Lemna gibba: Final Report: Lab Project Number: 93/11/5046: 10566/0493/6289/410. Unpublished study prepared by Springborn Lab., Inc. 72 p. 43227201 Dyer, I. (1994) MCPA DMA 750 g/I Al-Product Chemistry: Lab Project Number: AHM/EPA/93/ID/05. Unpublished study prepared by A H Marks & Co., Ltd. 37 p. 43227202 A. H. Marks & Co., Ltd. (1994) MCPA DMA 750 g/I AI-Beginning Materials Data Sheets and A H Marks' Purchase Specifications: Lab Project Number: AHM/EPA/93/ID/05. Unpublished study. 26 p. 43227203 A. H. Marks & Co., Ltd. (1994) A H Marks' Standard Analytical Methods: MCPA DMA 750: Lab Project Number: AHM/EPA/93/ID/05. Unpublished study. 32 p. 184 ------- 43227206 Sydney, P. (1993) Formulation of MCPA Dimethylamine Salt Containing 750 g/1: Determination of Physico-chemical Properties: Final Report: Lab Project Number: 93/0995: AMS/044: 93/AMS044/0995. Unpublished study prepared by Pharmaco- LSRLtd. 68 p. 43257901 Maggi, V. (1994) Tier II: The Effects of MCPA DMAS on Nontarget Plants: Seedling Emergence (MRID No. 426987-01): Supplemental Report to the Final Report #CAR 146-91F: Lab Project Number: CAR 195-93. Unpublished study prepared by California Agricultural Research, Inc. and EPL Bio-Analytical Services, Inc. 96 p. 43556801 Hellwig et. al. (1995) MCPA-2-EH-Ester - Subchronic oral toxicity study in beagle dogs - Administration in Diet. Department of Toxicology, BASF, Ludwigshafen/Rhine, FRG, Report No. 31D0385/91115, January 9, 1995. MRID 43556801. Unpublished. 43556802 Hellwig, J.; Bachmann, S.; Deckardt, K.; et al. (1995) MCPA-DMA Salt- Subchronic Oral Toxicity Study in Beagle Dogs: Administration in the Diet: Lab Project Number: 31D0385/91115. Unpublished study prepared by BASF Aktiengesellschaft. 407 p. 43556902 Kirsch, P.; Deckardt, K.; Gembardt, C.; et al. (1995) Study of the Dermal Toxicity of MCPA-DMA Salt in Wistar Rats: Application to the Intact Skin (21 Application): Lab Project Number: 37H0385/91147. Unpublished study prepared by BASF Aktiengesellschaft. 165 p. 43562701 Mellert, W.; Deckardt, K.; Kaufmann, W.; et al. (1994) MCPA-DMA Salt- Subchronic Oral Dietary Toxicity and Neurotoxicity Study in Wistar Rats: Lab Project Number: 50C0189/91140. Unpublished study prepared by BASF Aktiengesellschaft. 680 p. 43562702 Mellert, W.; Kaufmann, W.; Hildebrand, B. (1994) MCPA-DMA Salt-Acute Oral Neurotoxicity Study in Wistar Rats: Lab Project Number: 20S0189/91112. Unpublished study prepared by BASF Aktiengesellschaft. 405 p. 43580301 Sabourin, P. (1995) Nature of the Residue of (carbon 14)-2- Methyl-4- chlorophenoxyacetic Acid ((carbon 14)-MCPA) as the Dimethylamine Salt ((carbon 14)-MCPA DMA) and the 2-Ethylhexyl Ester ((carbon 14)-MCPA 2-EHE) in Wheat: Final Report: Lab Project Number: SC930053. Unpublished study prepared byBattelle. 318 p. 43697501 Singer, G. (1995) Terrestrial Field Dissipation of MCPA Dimethylamine Salt Following Ground Application to Wheat and Bareground: Lab Project Number: 185 ------- AA940507: 6576-100A: HWI 6576-100A. Unpublished study prepared by American Agricultural Services, Inc. and Hazleton Wisconsin, Inc. 1008 p. 43718401 Honey curt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA Dimethylamine Salt to Winter Wheat: Final Version: Lab Project Number: 93-211RA-1: 94019: 94018. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. 502 p. 43756401 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA Dimethylamine Salt to Spring Wheat: Final Report: Lab Project Number: 93-211RA-3: 95-503: 5-TW1. Unpublished study prepared by Quality Management & Analytical Services, Inc. and Hazard Evaluation & Regulatory Affairs Co., Inc. 403 p. 43788201 Hoberg, J. (1995) MCPA-DMA Salt-Determination of Effects on Vegetative Vigor of Five Plant Species: Lab Project Number: 13539.1294.6101.610: 95-5-5878. Unpublished study prepared by Springborn Labs, Inc. 142 p. 43791901 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA Dimethylamine Salt to Pasture Grass: Lab Project Number: 93-211RA-7: 95-507: 95025. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 736 p. 43793901 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA Dimethylamine Salt to Spring Wheat Underseeded with Alfalfa: Lab Project Number: 95-509: 93-211RA-9: 94027. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 814 p. 43801301 Honeycutt, R; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA Dimethylamine Salt to Rangeland Grass, Ground Application: Lab Project Number: 95-511: 93-211RA-11: QMAS 94029. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 689 p. 43841501 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues in Processed Fractions of Winter Wheat Following Treatment with MCPA Dimethylamine Salt: Lab Project Number: 93-211RA-5: 95-505: 94023. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Texas A&M University. 779 P- 43883001 Hatfield, M. (1995) Terrestrial Field Dissipation of MCPA Dimethylamine Salt 186 ------- Following Ground Application to Turfgrass and Bareground: Lab Project Number: AA940509: 12-9406: 6576-100D. Unpublished study prepared by American Agricultural Services, Inc.; Minnesota Valley Testing Lab; and Corning Hazleton Inc. 2381 p. 44026801 Fleming, P. (1996) Freezer Storage Stability For MCPA 2-EHE, MCPA, and Major Metabolites in Soil: Lab Project Number: 12-9410: RAM-10-047. Unpublished study prepared by Minnesota Valley Testing Laboratories, Inc. 139 p. 44192701 MacGregor, J.; Markley, B. (1996) External Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as its Acid Equivalent, 4-Chloro-2-methylphenoxyacetic Acid (MCPA), and 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) in Water Samples by Gas Chromatography with Mass Selective Detection: Lab Project Number: 364C-102: QMAM94002. Unpublished study prepared by Wildlife International Ltd. 64 p. 44407201 Drottar, K.; Krueger, H. (1997) MCPA DMAS: A Flow-Through Life-Cycle Toxicity Test with the Cladoceran (Daphnia magna): Lab Project Number: 364A- 101. Unpublished study prepared by Wildlife International Ltd. 92 p. (OPPTS 850.1300} 44407202 Drottar, K.; Krueger, H. (1997) MCPA DMAS: An Early Life-Stage Toxicity Test with the Fathead Minnow (Pimephales promelas): Lab Project Number: 364A-102. Unpublished study prepared by Wildlife International Ltd. 121 p. {OPPTS 850.1400} 44484501 Ohnsorge, U. (1997) Product Chemistry: Product Identity and Composition, Beginning Materials and Manufacturing Process, and Discussion of the Formation of Impurities of MCPA-DMA 750g/L MP: Lab Project Number: 97/11248. Unpublished study prepared by BASF Aktiengesellschaft. 60 p. {OPPTS 830.1550, 830.1600, 830.1650, 830.1670} 44484502 Ohnsorge, U. (1997) Product Chemistry: Certified Limits and Analytical Method for MCPA-DMA 750g/L MP: Lab Project Number: 97/11206: CF-A 491: 94/11730. Unpublished study prepared by BASF Aktiengesellschaft. 53 p. {OPPTS 830.1750} 44484503 Kaestel, R. (1997) Product Chemistry: Color, Physical State, Odor, Boiling Point, Density, pH, Flammability, Storage Stability, and Viscosity for MCPA-DMA 750g/L MP (BAS 141 24H): Lab Project Number: 97/11068: PCF 01842. Unpublished study prepared by BASF Aktiengesellschaft. 20 p. 187 ------- 44484504 Loeffler, U. (1997) Product Chemistry: Flammability for MCPA-DMA 750g/L MP (BAS 141 24H): Lab Project Number: 97/11327: SIK-NR. 97/1859. Unpublished study prepared by BASF Aktiengesellschaft. 8 p. 44484505 Kaestel, W. (1994) Product Chemistry: Shelf Life in Original Container (Storage Stability) for MCPA-DMA 550g/L EP (BAS 010 01H): Lab Project Number: 97/10380: PCF01468: PCF 01468. Unpublished study prepared by BASF Aktiengesellschaft. 31 p. 44484506 Koenig, W. (1994) Product Chemistry: Storage Stability for MCPA-DMA 550g/L EP (BAS 010 01H): Lab Project Number: 97/10004: PCF 01467. Unpublished study prepared by BASF Aktiengesellschaft. 12 p. 44535801 McKerlie, L. (1998) BAS 141 24H: Determination of Oxidizing or Reducing Action: Lab Project Number: 97221: FR9759: 97/5431. Unpublished study prepared by BASF Corp. 14 p. (OPPTS 830.6314}. 44535802 Cannan, T. (1998) BAS 141 24H: Determination of Corrosion Characteristics: Lab Project Number: 97210: FR9805: 98/5016. Unpublished study prepared by BASF Corp. 12 p. {OPPTS 830.6320} 44639901 Moszczynski, W. (1998) Supplement to Product Chemistry Report on MCPA TGAI: Lab Project Number: IPO 98/DN: MCPAOSCT: C/BFR0154. Unpublished study prepared by Institute of Industrial Organic Chemistry. 15 p. 44732401 Bashir, M. (1998) Aerobic Aquatic Metabolism of (carbon-14)-4-Chloro-2- Methylphenoxyacetic Acid Dimethylamine Salt: Lab Project Number: 6698-106. Unpublished study prepared by Covance Laboratories Inc. 134 p. {OPPTS 835.4300} 44903501 Drottar, K.; Krueger, H. (1999) MCPA DMAS: A 14-Day Toxicity Test With Duckweed (Lemna gibba G3): Final Report: Lab Project Number: 364A-103: 364/040798/LEM14DR/SUB364. Unpublished study prepared by Wildlife International Ltd. 72 p. 44903502 Palmer, S.; Kendall, T.; Kreuger, H. (1999) MCPA DMAS: A 5-Day Toxicity Test With the Freshwater Alga (Selenastrum capricornutum): Lab Project Number: 364A-104: 364/102798/SEL5D2WC/SUB364. Unpublished study prepared by Wildlife International Ltd. 80 p. {OPPTS 850.5400} 44903503 Palmer, S.; Kendall, T.; Kreuger, H. (1999) MCPA DMAS: A 5-Day Toxicity Test With the Freshwater Alga (Anabaena flos-aquae): Final Report: Lab Project Number: 364A-105B: 364/102798/ANA5D2WC/SUB364. Unpublished study 188 ------- prepared by Wildlife International Ltd. 81 p. (OPPTS 850.5400} 44903504 Palmer, S.; Kendall, T.; Kreuger, H. (1999) MCPA DMAS: A 5-Day Toxicity Test With the Freshwater Diatom (Navicula pelliculosa): Final Report: Lab Project Number: 364A-106A: 364/102798/NAV5D2WC/SUB364. Unpublished study prepared by Wildlife International Ltd. 82 p. 44903505 Palmer, S.; Kendall, T.; Kreuger, H. (1999) MCPA DMAS: A 5-Day Toxicity Test With the Marine Diatom (Skeletonema costatum): Final Report: Lab Project Number: 364A-107: 364/102798/SKE5D2WC/SUB364. Unpublished study prepared by Wildlife International Ltd. 82 p. {OPPTS 850.5400} 44954102 Cappon, G. (1999) A Prenatal Developmental Toxicity Study of MCPA-DMA in Rats: Final Report: Lab Project Number: WIL-325003. Unpublished study prepared by WIL Research Laboratories, Inc. 464 p. {OPPTS 870.3700} Relates to L0000410. 45033101 Hughes, D.; Bomkamp, D. (2000) Determination of Transferable Turf Residues on Turf Treated with 2,4-D, MCPA DMA, 2,4-D DMA + MCPP-p DMA + Dicamba DMA and MCPA DMA + MCPP-p DMA + 2,4-DP-p DMA: Lab Project Number: BTH TFR TF 003: 6926-105. Unpublished study prepared by Covance Laboratories. 394 p. {OPPTS 875.2100} 45288701 Morrissey, M.; Eberhard, J. (2000) Independent Laboratory Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) and 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as their 4-Chloro-2-methylphenoxyacetic Acid (MCPA) Equivalent, MCPA, 4-Chloro-2-hydroxymethylphenoxyacetic Acid (HMCPA), 4- Chloro-2-hydroxymethylphenoxyacetic Acid Glucose Conjugate (HMCPA GLU) as its HMCPA Equivalent, and 4-Chloro-2-carboxyphenoxyacetic Acid (CCPA) in Wheat Forage, Straw, and Grain: Final Report: Lab Project Number: 6698-108: 6698-107. Unpublished study prepared by Covance Laboratories Inc. 449 p. 45288702 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Winter Wheat: Lab Project Number: GR97-267: 6698-116: 6698-107. Unpublished study prepared by Grayson Research, LLC. 519 p. {OPPTS 860.1500} 45288703 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Spring Wheat: Lab Project Number: GR97-269: 6698-107: 6698-118. Unpublished study prepared by Grayson Research, LLC. 445 p. {OPPTS 860.1500} 189 ------- 45288704 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Pasture Grass: Lab Project Number: GR97-273: 6698-111: QMAM94002. Unpublished study prepared by Grayson Research, LLC. 361 p. (OPPTS 860.1500} 45288705 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Wheat Underseeded with Alfalfa: Lab Project Number: GR97-258: 97258-1: 97258-2. Unpublished study prepared by Grayson Research, LLC. 392 p. (OPPPTS 860.1500} 45288706 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt to Rangeland Grass: Lab Project Number: GR97- 275: 97275: 97275-1. Unpublished study prepared by Grayson Research, LLC. 317 p. {OPPTS 860.1500} 45312201 Mayer, P.; Oldersma, H.; Hanstveit, A. (2000) Determination of the Effect of MCPA DMAS on the Growth of the Fresh Water Green Alga Selenastrum capricornutum: Lab Project Number: 00-2317/01: V2317/01. Unpublished study prepared by TNO Nutrition and Food Research. 39 p. {OPPTS 850.5400}. 45480901 Brown, A. (2001) MCPA-DMA 750g/L: One Year Shelf-Life Storage Stability and Corrosion Characteristics in Commercial Type Containers: Final Report: Lab Project Number: MI-0011. Unpublished study prepared by Micro Flo Company. 8 p. {OPPTS 830.6317 and 830.6320} 45503801 Mayer, P.; Oldersma, H.; Hanstveit, A. (2001) Determination of the Effect of MCPA DMAS on the Growth of the Fresh Water Green Alga Selenastrum capricornutum: Addendum: Lab Project Number: ALGENTOX/180400: 00- 2317/01: TNO RPT V2317/01. Unpublished study prepared by Nufarm (UK) Ltd. 43 p. 45549601 Eberhard, J. (2001) Final Report: Freezer Storage Stability Study for MCPA DMAS, 4-Chloro-2-hydroxymethylphenoxyacetic Acid (2-HMCPA) and 4- Chloro-2-carboxyphenoxyacetic Acid (CCPA) and MCPA 2-EHE in Selected Plant Matrices: Lab Project Number: 6698-122. Unpublished study prepared by Covance Laboratories Inc. 1353 p. {OPPTS 860.1380} 45554403 Kranzfelder, J. (2000) Toxicity of MCPA DMAS to the Unicellular Green Alga, Selenastrum capricornutum, Determined Under Static Test Conditions: Lab Project Number: 45963. Unpublished study prepared by ABC Laboratories, Inc. 61 p. 45763101 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues From.Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to 190 ------- Spring Wheat in Haywood, Manitoba: Lab Project Number: GR01-394: 01-394.1: 01-394. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and ICMS, Inc. 520 p. (OPPTS 860.1500} 45763102 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Elm Creek, Manitoba: Lab Project Number: GR01-413: 01-413.1: 01-413. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 515 p. {OPPTS 860.1500} 45763103 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Barnwell, Alberta: Lab Project Number: GR01-414: 01-414.1: 01- 414. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 522 p. {OPPTS 860.1500} 45763104 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Fairview, Alberta: Lab Project Number: GR01-415: 01-415.1: 02GRY17.REP. Unpublished study prepared by Grayson Research, LLC., Enviro- Test Laboratories, Inc. and Three Links Ag Research. 502 p. {OPPTS 860.1500} 45763105 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Rosthern, Saskatchewan: Lab Project Number: GR01-416: 01- 416.1: 02GRY18.REP. Unpublished study prepared by Grayson Research, LLC., Ag Quest, Inc. and Enviro-Test Laboratories, Inc. 583 p. {OPPTS 860.1500} PC Code 030564 MRID Citation Reference 156458 Ullmann, L. (1985) Acute Oral Toxicity (LD50) Study with CL 8808/7 CE in Rats: Report: Project 041927. Unpublished study prepared by Research & Consulting Co. AG. 42 p. 156459 Ullmann, L. (1985) Acute Dermal Toxicity (LD50) Study with CL 8808/7 CE in Rats: Report: Project 042006. Unpublished study prepared by Research & Consulting Co. AG. 23 p. 156460 Ullmann, L. (1985) 4-Hour Acute Aerosol Inhalation Toxicity (LC50) Study with 191 ------- CL 8808/7 CE in Rats: Report: Project 042017. Unpub- lished study prepared by Research & Consulting Co. AG. 35 p. 156522 Ullmann, L. (1985) Primary Eye Irritation Study with CL 8808/7 CE i Rabbits: Report: Project 053583. Unpublished study prepared by Research & Consulting Co. AG. 30 p. 42853506 Akhurst, L.; King, J.; Anderson, A.; et al. (1993) MCPA 2-EHE Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro: Lab Project Number: JEL 31/921188. Unpublished study prepared by Huntingdon Research Centre Ltd. 45 p. 42860102 Adams, K.; Henly, S.; Anderson, A.; et al. (1993) Chinese Hamster Ovary/HGPRT Locus Assay: MCPA 2-EHE: Final Report: Lab Project Number: JEL 28/921114. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p. 42870001 Jones, E.; Kitching, J.; Anderson, A.; et al. (1993) Ames Salmonella typhimurium Bacterial Reverse Mutation Assay on MCPA 2-EHE: Final Report: Lab Project Number: JEL 25/921054. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p. 43083211 Hoberg, J. (1993) MCPA-2EH Ester Technical-Toxicity to the Freshwater Diatom, Navicula pelliculosa: Final Report: Lab Project Number: 10566.0493.6293.440: 93- 10-4993. Unpublished study prepared by Springborn Laboratories, Inc. 68 p. 43083212 Hoberg, J. (1993) MCPA-2EH Ester Technical-Toxicity to the Marine Diatom, Skeletonema costatum: Final Report: Lab Project Number: 10566.0493.6299.450: 93-10-4982. Unpublished study prepared by Springborn Laboratories, Inc. 69 p. 43083213 Hoberg, J. (1993) MCPA-2EH Ester Technical-Toxicity to the Freshwater Blue- Green Alga, Anabaena flos-aquae: Final Report: Lab Project Number: 10566.0493.6296.420: 93-9-4939. Unpublished study prepared by Springborn Laboratories, Inc. 64 p. 43083214 Hoberg, J. (1993) MCPA-2EH Ester Technical-Toxicity to Duckweed, Lemna gibba: Final Report: Lab Project Number: 10566.0493.6290. 410: 93-10-4976. Unpublished study prepared by Springborn Laboratories, Inc. 70 p. 43086501 Bettencourt, M. (1993) MCPA-2EH Ester Technical-Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) under Flow-through Conditions: Final Report: Lab Project Number: 93/9/4928. Unpublished study prepared by Springborn Laboratories, Inc. 66 p. 43129310 Dinwoodie, N. (1993) MCPA 2EH Ester Determination of Physical Chemical 192 ------- Properties: Lab Project Number: IRI351815: 9618. Unpublished study prepared by Inveresk Research Laboratories. 56 p. 43556701 Mellert, W.; Deckardt, K.; Kaufmann, W.; et al. (1994) MCPA-2-EH Ester- Subchronic Oral Dietary Toxicity and Neurotoxicity Study in Wistar Rats: Lab Project Number: 50C0385/91141. Unpublished study prepared by BASF Aktiengesellschaft. 686 p. 43556702 Mellert, W.; Kaufmann, W.; Hildenbrand, B.; et al. (1994) MCPA-2-EH Ester- Acute Oral Neurotoxicity Study in Wistar Rats: Lab Project Number: 20S0385/91113. Unpublished study prepared by BASF Aktiengesellschaft. 391 p. 43556801 Hellwig, J.; Bachmann, S.; Deckardt, K.; et al. (1995) MCPA-2-EH-Ester- Subchronic Oral Toxicity Study in Beagle Dogs: Administration in the Diet: Lab Project Number: 31D0385/91115. Unpublished study prepared by BASF Aktiengesellschaft. 398 p. 43580301 Sabourin, P. (1995) Nature of the Residue of (carbon 14)-2- Methyl-4- chlorophenoxyacetic Acid ((carbon 14)-MCPA) as the Dimethylamine Salt ((carbon 14)-MCPA DMA) and the 2-Ethylhexyl Ester ((carbon 14)-MCPA 2-EHE) in Wheat: Final Report: Lab Project Number: SC930053. Unpublished study prepared byBattelle. 318 p. 43 7243 01 Honey curt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Winter Wheat: (Final Report): Lab Project Number: 95-502: 93-211RA-2: QMAS 94020. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. 507 p. 43 724401 Honey curt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Spring Wheat: Final Version: Lab Project Number: 95-504: 93-211RA-4: QMAS 94022. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 402 p. 43 764101 Honey curt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues in Processed Fractions of Winter Wheat Following Treatment with MCPA 2-Ethylhexyl Ester: Lab Project Number: 93-211RA-6: 95-506: 94024. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc.; Quality Management & Analytical Services, Inc.; and Texas A&M Univ. 683 p. 43782401 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Pasture Grass: Lab Project Numbers: 95-508: 93-211RA-8: 94026. Unpublished study prepared by Hazard Evaluation & 193 ------- Regulatory Affairs Co., Inc. 722 p. 43804601 Honeycutt, R; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Spring Wheat Underseeded with Alfalfa: Lab Project Number: 95-510: 93-211RA-10: 94028. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 814 p. 43 826401 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Rangeland Grass, Ground Application: Lab Project Number: 93-211RA-12: 95-512: QMAS 94030. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 680 p. 43 826402 Honeycutt, R.; DeGeare, M. (1995) Magnitude of MCPA Residues from Application of MCPA 2-Ethylhexyl Ester to Rangeland Grass, Aerial Application: Lab Project Number: 93-211RA-13: 95-513: QMAS 94031. Unpublished study prepared by Hazard Evaluation & Regulatory Affairs Co., Inc. and Quality Management & Analytical Services, Inc. 413 p. 44192701 MacGregor, J.; Markley, B. (1996) External Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as its Acid Equivalent, 4-Chloro-2-methylphenoxyacetic Acid (MCPA), and 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) in Water Samples by Gas Chromatography with Mass Selective Detection: Lab Project Number: 364C-102: QMAM94002. Unpublished study prepared by Wildlife International Ltd. 64 p. 44655702 Barney, W. (1998) Determinaton of Transferable Turf Residues on Turf Treated with 2,4-D, 2,4-DP, MCPA, MCPP-p and Dicamba: Lab Project Number: BTH TFR TF 001: 98-313: 6926-103. Unpublished study prepared by Grayson Research, LCC. and Covance Laboratories Inc. 521 p. (OPPTS 875.2100} 44914027 Cookinham, J. (1999) Bronate Herbicide Product Chemistry: Lab Project Number: 5605-F. Unpublished study prepared by Midwest Research Institute. 126 p. {OPPTS 830.1550, 830.1620, 830.1670, 830.1750} 44929001 Sawyer, R. (1999) Product Chemistry: Riverdale MCPA Technical IOE: Lab Project Number: IOE-MCPA TECHNICAL. Unpublished study prepared by Riverdale Chemical Co. 4 p. 44954101 Cappon, G (1999) A Prenatal Developmental Toxicity Study of MCPA-2-EHE in Rats: Final Report: Lab Project Number: WIL-325004. Unpublished study prepared 194 ------- by WIL Research Laboratories, Inc. 447 p. (OPPTS 870.3700} Relates to L0000410. 45173401 Sawyer, R. (1999) Product Chemistry: Riverdale MCPA Technical IOE. Unpublished study prepared by Riverdale Chemical Company. 8 p. 45288701 Morrissey, M.; Eberhard, J. (2000) Independent Laboratory Validation of a Method for the Determination of 4-Chloro-2-methylphenoxyacetic Acid 2-Ethylhexyl Ester (MCPA 2-EHE) and 4-Chloro-2-methylphenoxyacetic Acid Dimethylamine Salt (MCPA DMAS) as their 4-Chloro-2-methylphenoxyacetic Acid (MCPA) Equivalent, MCPA, 4-Chloro-2-hydroxymethylphenoxyacetic Acid (HMCPA), 4- Chloro-2-hydroxymethylphenoxyacetic Acid Glucose Conjugate (HMCPA GLU) as its HMCPA Equivalent, and 4-Chloro-2-carboxyphenoxyacetic Acid (CCPA) in Wheat Forage, Straw, and Grain: Final Report: Lab Project Number: 6698-108: 6698-107. Unpublished study prepared by Covance Laboratories Inc. 449 p. 45288708 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Applications of MCPA 2-Ethylhexyl Ester to Winter Wheat: Lab Project Number: GR97-268: 97268: 6698-117. Unpublished study prepared by Grayson Research, LLC. Slip. {OPPTS 860.1500} 45288709 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Spring Wheat: Lab Project Number: GR97-270: 6698-119: 6698-107. Unpublished study prepared by Grayson Research, LLC. 464 p. {OPPTS 860.1500} 45288710 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Pasture Grass: Lab Project Number: GR97-274: 97274: 97274-1. Unpublished study prepared by Grayson Research, LLC. 368 p. {OPPTS 860.1500} 45288711 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Rangeland Grass: Lab Project Number: GR97-276: 97276: 97276-1. Unpublished study prepared by Grayson Research, LLC. 334 p. {OPPTS 860.1500} 45288712 Kludas, R. (2000) Magnitude of MCPA and Metabolite Residues from Application of MCPA 2-Ethylhexyl Ester to Wheat Underseeded with Alfalfa: Lab Project Number: G97-266: 6698-110: 6698-107. Unpublished study prepared by Grayson Research, LLC. 288 p. {OPPTS 860.1500} 45763101 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues From Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to 195 ------- Spring Wheat in Haywood, Manitoba: Lab Project Number: GR01-394: 01-394.1: 01-394. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and ICMS, Inc. 520 p. (OPPTS 860.1500} 45763102 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Elm Creek, Manitoba: Lab Project Number: GR01-413: 01-413.1: 01-413. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 515 p. {OPPTS 860.1500} 45763103 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Barnwell, Alberta: Lab Project Number: GR01-414: 01-414.1: 01- 414. Unpublished study prepared by Grayson Research, LLC., Enviro-Test Laboratories, Inc. and Ag-Quest, Inc. 522 p. {OPPTS 860.1500} 45763104 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Fairview, Alberta: Lab Project Number: GR01-415: 01-415.1: 02GRY17.REP. Unpublished study prepared by Grayson Research, LLC., Enviro- Test Laboratories, Inc. and Three Links Ag Research. 502 p. {OPPTS 860.1500} 45763105 Barney, W. (2002) Magnitude of MCPA and Metabolite Residues from Application of MCPA Dimethylamine Salt, MCPA 2-Ethylhexyl Ester and MCPA Acid to Spring Wheat in Rosthern, Saskatchewan: Lab Project Number: GR01-416: 01- 416.1: 02GRY18.REP. Unpublished study prepared by Grayson Research, LLC., Ag Quest, Inc. and Enviro-Test Laboratories, Inc. 583 p. {OPPTS 860.1500} 45804401 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: Product Identity and Composition: Lab Project Number: USA/MCPA 2EH/MCPA 2EHVOL1. Unpublished study prepared by A.H. Marks and Company Ltd. lip. {OPPTS 830.1550} 45804402 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: Description of Materials Used to Produce the Product: Lab Project Number: USA/MCPA 2EH/MCPA 2EHVOL2. Unpublished study prepared by A.H. Marks and Company Ltd. 58 p. {OPPTS 830.1600} 45804403 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: Description of Production Process: Lab Project Number: USA/MCPA 2EH/MCPA 2EHVOL3: 553: 552. Unpublished study prepared by A.H. Marks and Company Ltd. 60 p. {OPPTS 830.1620} 196 ------- 45804404 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: Discussion of Formation of Impurities: Lab Project Number: USA/MCPA 2EH/MCPA 2EH VOL4. Unpublished study prepared by A.H. Marks and Company Ltd. 12 p. (OPPTS 830.1670} 45804405 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: 5 Batch Analysis Study Report: Lab Project Number: USA/MCPA 2EH/MCPA 2EH VOL5: 00/0124. Unpublished study prepared by A.H. Marks and Company Ltd. 123 p. 45804406 Hale, M. (2002) MCPA 2EH Technical: Product Chemistry: Preliminary Analysis, Certified Limits, Enforcement Analytical Method: Lab Project Number: USA/MCPA 2EH/MCPA 2EHVOL6: AHM 00/MCPA 2EH: 322. Unpublished study prepared by AH. Marks and Company Ltd. 48 p. {OPPTS 830.1700, 830.1750, 830.1800} 197 ------- Appendix E. Generic Data Call-In A Data Call-In (DCI), with all pertinent instructions, was sent to registrants in March 2006 under separate cover. 198 ------- Appendix F. Product-Specific Data Call-In A Data Call-In (DCI), with all pertinent instructions, was sent to registrants in March 2006 under separate cover. 199 ------- Appendix G. EPA'S Batching of MCPA Products for Meeting Acute Toxicity Data Requirements for Reregistration In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregi station of products containing MCPA as the active ingredient the Agency has batched products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition and biological activity! type of formulation (e.g.. emulsifiable concentrate, aerosol, wettable powder. granular, etc.). and labeling (e.g.. signal word, use classification, precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may not be considered chemically similar or have identical use patterns. Using available information, batching has been accomplished by the process described in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise. Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute lexicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute lexicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF. In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product. The second form, "Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to.support a batch of products, he/she 200 ------- must select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies. One hundred seventy three products were found which contain MCPA as the active ingredient. These products have been placed into 4 sections: MCPA Acids (PC Code 030501 - contains 34 products placed in 6 batches and a No Batch group); MCPA Sodium Salts (PC Code 030502 - contains 5 products placed in 1 batch and a No Batch group); MCPA Amine Salts (PC Code 030516 - contains 90 products placed in 16 batches and a No Batch group); MCPA 2-ethylhexyl ester (PC Code 030564 - contains 44 products placed in 5 batches and a No Batch group). All were placed in these batches in accordance with the active and inert ingredients and type of formulation. Two esters from acid and sodium salt groups (EPA Reg. Nos. 2217-873 & 62719-8) have been batched with other esters. Furthermore, the following bridging strategies are deemed acceptable for this chemical: MCPA Acids: Batch 2 - EPA Reg. No. 2217-722 may not cite data from EPA Reg. No. 2217-821. Batch 3 - EPA Reg. No. 2217-750 may not cite data from EPA Reg. No. 2217-784. Batch 6 - EPA Reg. Nos. 228-300 & 2217-822 may not cite data from EPA Reg. Nos. 228- 301,2217-798, & 2217-799. MCPA Amine Salts: Batch 1 - EPA Reg. Nos. 11685-23 & 15440-27 may not cite data from EPA Reg. No. 228- 290. Batch 8 - EPA Reg. No. 228-349 may not cite data from EPA Reg. No. 228-350. Batch 9 - EPA Reg. No. 228-269 may not cite data from EPA Reg. Nos. 228-270 or 228-330. Batch 10 - EPA Reg. No. 228-324 may not cite data from EPA Reg. No. 228-326. Batch 12 - EPA Reg. Nos. 228-219 & 228-225 may not cite data from EPA Reg. No. 228- 226. Batch 13 - EPA Reg. No. 228-229 may not cite data from EPA Reg. No. 228-224. Batch 14 - EPA Reg. No. 228-272 may not cite data from 2217-792. Batch 15 - EPA Reg. Nos. 228-286, 228-229, & 228-327 may not cite data from 228-304. 201 ------- All sections: No Batch: All products in each of the No Batch groups should generate their own data. NOTE: The technical acute toxicity values included in this document are for informational purposes only. The data supporting these values may or may not meet the current acceptance criteria. MCPA ACIDS (PC Code 0305011 Batch 1 EPA Res. No. 11685-13 11685-14 11685-22 15440-7 15440-21 35935-8 35935-9 62719-60 67591-2 70596-1 % Active Ingredient 94.0 94.0 96.0 95.0 94.0 95.0 95.0 96.6 95.0 96.6 Batch 2 EPA Reg. No. % Active Ingredient 2217-722 MCPA: 45.59 MCPP: 10.20 Dicamba: 4.30 202 ------- Batch 2 EPA Reg. No. 2217-821 % Active Ingredient MCPA: 45.00 MCPP: 9.00 Dicamba: 4.50 Batch 3 EPA Reg. No. 2217-750 2217-784 % Active Ingredient MCPA acid: 32.43 MCPP: 7.26 Dicamba: 3.06 MCPA acid: 32.43 MCPP: 6.48 Dicamba: 3.24 Batch 4 EPA Reg. No. 5905-510 11685-20 62719-58 % Active Ingredient 23.7 24.0 23.7 Batch 5 EPA Res. No. 538-160 538-218 % Active Ingredient MCPA: 1.37 MCPP: 1.37 MCPA: 1.37 MCPP: 1.37 203 ------- Batch 5 EPA Reg. No. 538-222 9198-198 % Active Ingredient MCPA: 1.37 MCPP: 1.37 MCPA: 1.37 MCPP: 1.37 Batch 6 EPA Reg. No. 228-300 228-301 2217-798 2217-799 2217-822 % Active Ingredient MCPA: 0.820 MCPP: 0.1 65 Dicamba: 0.080 MCPA: 0.630 MCPP: 0.125 Dicamba: 0.060 MCPA: 0.690 MCPP: 0.1 50 Dicamba: 0.060 MCPA: 0.560 MCPP: 0.120 Dicamba: 0.050 MCPA: 0.820 MCPP: 0.330 Dicamba: 0.08 No Batch EPA Reg. No. 228-199 % Active Ingredient 22.25 204 ------- No Batch EPA Reg. No. 228-228 228-285 228-306 2217-873 10404-70 42750-24 62719-8 % Active Ingredient MCPA: 17.0 MCPP: 8.5 Dichlorrjroo: 8.5 MCPA: 50.0 MCPP: 20.0 Dicamba: 5.0 MCPA: 0.82 MCPP: 0.33 Dicamba: 0.08 MCPA: 43.09 MCPP: 5.64 Carfentrazone-ethyl: 0.50 MCPA: 3 1.50 MCPP: 12.70 Dicamba: 3.30 22.25 23.70 MCPA SODIUM SALTS (PC Code 030502s) Batch 1 EPA Reg. No. 228-199 5905-510 62719-58 % Active Ingredient 22.25 23.70 23.70 205 ------- No Batch EPA Reg. No. 11685-20 42750-24 % Active Ingredient 24.00 22.25 MCPA AMINE SALTS (PC Code 030516s) Batch 1 EPA Res. No. 228-290 11685-23 15440-27 % Active Ingredient 75.0 77.9 77.8 Batch 2 Batch 3 Batch 4 EPA Reg. No. 34704-130 67591-01 EPA Reg. No. 11685-19 71368-55 EPA Reg. No. 2217-362 % Active Ingredient 52.0 52.0 % Active Ingredient 52.1 52.1 % Active Ingredient 50.37 206 ------- Batch 4 EPA Reg. No. 5905-502 15440-37 62719-13 % Active Ingredient 52.2 52.1 52.1 Batch 5 EPA Reg. No. 228-143 1381-104 % Active Ingredient 48.58 48.72 Batch 6 EPA Reg. No. 228-271 228-310 % Active Ingredient MCPA: 10.10 MCPP: 2.00 Dicamba: 0.99 MCPA: 10.10 MCPP: 2.00 Dicamba: 0.99 Batch 7 EPA Reg. No. % Active Ingredient 228-334 MCPA: 13.72 Triclopyr:1.56 Dicamba: 1.35 207 ------- Batch 7 Batch 8 EPA Res. No. 228-424 EPA Reg. No. 228-349 228-350 % Active Insredient MCPA: 13.72 Triclopyr:1.56 Dicamba: 1.35 % Active Ingredient MCPA: 13.47 Clopvralid:1.45 Dicamba: 1.32 MCPA: 10.78 Clopvralid:1.16 Dicamba: 1.06 Batch 9 EPA Reg. No. 228-269 228-270 228-330 % Active Ingredient MCPA: 1.01 MCPP: 0.40 Dicamba: 0.09 MCPA: 0.808 MCPP: 0.1 57 Dicamba: 0.079 MCPA: 0.808 MCPP: 0.1 57 Dicamba: 0.060 208 ------- Batch 10 EPA Reg. No. 228-324 228-325 228-326 % Active Ingredient MCPA: 1.625 Triclopvr: 0.184 Dicamba: 0.159 MCPA: 1.100 Triclopvr: 0.120 Dicamba: 0.110 MCPA: 0.820 Triclopyr: 0.093 Dicamba: 0.080 Batch 1 1 EPA Reg. No. 2217-730 2217-737 % Active Ingredient MCPA: 2.093 MCPP: 1.858 Dicamba: 0.412 MCPA: 2.818 MCPP:0.672 Dicamba: 0.313 Batch 12 EPA Reg. No. % Active Ingredient 228-219 MCPA: 0.416 MCPP: 0.206 2.4-DP: 0.203 209 ------- Batch 12 EPA Res. No. % Active Ingredient 228-225 228-226 MCPA:0.318 MCPP:0.314 2.4-DP:0.310 MCPA:0.159 MCPP:0.157 2.4-DP:0.155 Batch 13 EPA Reg. No. 228-224 228-229 % Active Ingredient MCPA: 0.331 MCPP:0.163 2.4-DP: 0.161 MCPA: 0.416 MCPP:0.411 2.4-DP: 0.405 Batch 14 EPA Reg. No. % Active Ingredient 228-272 2217-792 MCPA: 0.67 MCPP:0.13 Dicamba: 0.06 MCPA: 0.34 MCPP:0.31 Dicamba: 0.07 210 ------- Batch 15 EPA Reg. No. 228-286 228-299 228-304 228-327 % Active Ingredient MCPA: 0.750 MCPP: 0.145 Dicamba: 0.072 MCPA: 0.646 MCPP: 0.255 Dicamba: 0.064 MCPA: 0.404 MCPP: 0.079 Dicamba: 0.036 MCPA: 0.701 MCPP: 0.080 Dicamba: 0.069 Batch 16 EPA Reg. No. 9779-262 42750-14 % Active Ingredient 48.89 48.89 No Batch EPA Reg. No. 228-204 228-206 % Active Ingredient MCPA: 3. 31 MCPP: 3.26 DichlororoD: 3.22 MCPA: 17.15 MCPP: 8.47 Dichlorprop: 8.34 211 ------- No Batch EPA Reg. No. 228-215 228-217 228-218 228-262 228-266 228-276 228-277 228-279 228-284 228-296 % Active Ingredient MCPA: 1.65 MCPP: 1.63 DichlororoD: 1.61 MCPA: 4.78 MCPP: 2.36 Dichlororoo: 2.33 MCPA: 1.41 MCPP: 1.39 DichlororoD: 1.37 MCPA: 40.42 MCPP: 7.99 Dicamba: 3.97 MCPA: 14.0 MCPP: 10.0 MCPA: 6.46 MCPP: 2.50 Dicamba: 0.63 MCPA: 3.23 MCPP: 1.28 Dicamba: 0.31 95.5 MCPA: 0.67 MCPP: 0.27 Dicamba: 0.06 MCPA: 32.6 Dicamba: 16.0 212 ------- No Batch EPA Reg. No. 228-303 228-313 228-323 228-328 228-333 228-335 228-336 228-351 228-352 % Active Ingredient MCPA: 1.01 MCPP: 0.40 Dicamba: 0.09 MCPA: 48.99 Triclopyr: 5.59 Dicamba: 4.82 MCPA: 48. 13 Clopyralid: 5.18 Dicamba: 4.73 MCPA: 1.10 Triclopvr: 0.12 Dicamba: 0.11 MCPA: 48. 13 Clopyralid: 2.58 Dicamba: 4.73 MCPA: 10.97 Triclopyr: 1.25 Dicamba: 1.08 MCPA: 0.740 Triclopyr: 0.084 Dicamba: 0.072 MCPA: 0.843 Clopvralid: 0.090 Dicamba: 0.082 MCPA: 0.707 Clopyralid: 0.076 Dicamba: 0.069 213 ------- No Batch EPA Reg. No. 228-353 228-371 228-372 228-411 228-419 239-2621 239-2634 432-892 1386-587 % Active Ingredient MCPA: 1.300 Clopvralid: 0.140 Dicamba: 0.128 MCPA: 37.9 Triclopyr: 3.8 CloDvralid: 1.3 MCPA: 47.77 Clopvralid: 2.53 DichlororoD: 9.54 MCPA: 46.87 Triclopvr: 10.68 Dichlororoo: 9.12 MCPA: 5 1.05 Fluroxypyr: 12.00 Dicamba: 4.17 MCPA: 7.36 MCPP: 13.41 Dicamba: 1.49 MCPA: 0.1 5 MCPP: 0.30 Dicamba: 0.03 MCPA: 34.47 MCPP: 16.35 Dicamba: 3.76 MCPA: 52.2 214 ------- No Batch EPA Reg. No. 2217-720 2217-721 2217-729 2217-731 2217-732 2217-733 2217-734 2217-735 2217-736 2217-738 % Active Ingredient MCPA: 19.07 MCPP: 17.37 Dicamba: 3.85 MCPA: 34.47 MCPP: 8.18 Dicamba: 3.76 MCPA: 38.28 MCPP: 12.60 MCPA: 5.608 MCPP: 1.335 Dicamba: 0.614 MCPA: 7.35 MCPP: 6.71 Dicamba: 1.47 MCPA: 3.77 MCPP: 3.43 Dicamba: 0.76 MCPA: 9.43 MCPP: 2.24 Dicamba: 1.03 MCPA: 6.98 MCPP: 2.30 MCPA: 1.029 MCPP: 0.932 Dicamba: 0.205 MCPA: 3.638 MCPP: 1.198 215 ------- No Batch EPA Reg. No. 2217-743 2217-744 2217-745 2217-773 2217-785 2217-786 2217-797 7969-78 8660-227 % Active Ingredient MCPA: 0.353 MCPP: 0.321 Dicamba: 0.071 MCPA: 0.98 MCPP: 0.23 Dicamba: 0.11 MCPA: 1.20 Mecooroo: 0.40 MCPA: 38.68 MCPP: 8.16 Dicamba: 3.81 MCPA: 2.05 MCPP: 1.86 Dicamba: 0.41 MCPA: 5.63 MCPP: 1.33 Dicamba: 0.61 MCPA: 6.21 Monosodium methanearsonate: 18.70 MCPP: 3.09 Dicamba: 1.48 MCPA: 6.2 Sodium Bentazon: 37.0 MCPA: 0.3 18 MCPP: 0.3 14 2.4-DP:0.310 216 ------- No Batch EPA Reg. No. 62719-62 % Active Ingredient MCPA: 63.5 MCPA 2-ethvlhexvl ester (PC Code 030564} Batch 1 EPA Reg. No. 228-267 228-289 11685-15 11685-24 15440-9 35935-10 62719-64 67591-3 % Active Ingredient 91.0 97.0 93.0 97.0 97.5 94.0 95.8 99.9 Batch 2 EPA Reg. No. 228-156 1381-98 9779-265 11685-21 42750-23 71368-56 % Active Ingredient 68.7 68.7 69.7 67.9 69.7 67.9 217 ------- Batch 3 EPA Reg. No. 35935-20 42750-25 71368-16 % Active Ingredient 66.50 66.51 65.30 Batch 4 EPA Res. No. % Active Ingredient 228-317 228-395 MCPA:56.14 Triclopyr: 5.00 Dicamba: 3.60 MCPA:56.14 Triclopyr: 5.00 Dicamba: 3.60 Batch 5 EPA Reg. No. 264-438 5905-550 42750-52 51036-254 71368-28 % Active Ingredient MCPA: 34.0 Bromoxvnil: 31.7 MCPA: 34.0 Bromoxynil: 31.7 MCPA: 34.0 Bromoxynil: 31.7 MCPA: 34.0 Bromoxynil: 31.7 MCPA: 34.0 Bromoxynil: 31.7 218 ------- No Batch EPA Reg. No. 228-203 228-205 264-649 264-654 264-655 264-690 264-699 554-125 1381-175 2217-803 % Active Ingredient MCPA: 1.0 Mecoprop: 0.6 MCPA: 25.6 Mecoprop: 25.0 2.4-DP: 24.2 MCPA: 32. 11 Fenoxaprop-p-ethyl: 4.41 2.4-D: 10.35 MCPA: 37.66 Fenoxaprop-p-ethyl: 5.29 MCPA: 49.43 Fenoxaprop-p-ethyl: 2.64 MCPA: 40.0 Bromoxynil octanoate: 18.7 Bromoxynil heptonoate: 18.1 MCPA: 30.7 Bromoxynil octanoate: 18.5 Bromoxynil heptonoate: 17.9 74.93 MCPA: 43.03 Carfentrazone-ethyl: 1.39 MCPA: 26.83 MCPP: 3.44 Dicamba: 1.72 219 ------- No Batch EPA Reg. No. 2217-834 2217-863 2217-865 2217-873 5905-506 62719-59 62719-86 62719-307 62719-513 71368-17 % Active Ingredient MCPA:41.98 MCPP: 5.39 Dicamba: 2.69 Carfentrazone-ethyl: 0.48 MCPA:31.55 MCPP: 6. 16 Dicamba: 1.65 Carfentrazone-ethyl: 0.22 MCPA: 0.337 MCPP: 0.066 Dicamba: 0.018 Carfentrazone-ethyl: 0.002 MCPA: 43.09 MCPP: 5.64 Carfentrazone-ethyl: 0.50 74.4 74.4 MCPA: 43.4 Clopvralid: 5.0 MCPA: 52.0 Fluroxypyr: 12.0 MCPA: 43.4 Clopvralid: 5.0 Fluroxypyr: 26.2 81.9 220 ------- 221 ------- Appendix H. List of Registrants Sent This Data Call-In 222 ------- Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY AVAILABLE FORMS Pesticide Registration Forms are available at the following EPA internet site: http://www.epa.gov/opprd001/fortns/ Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) Instructions L Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your computer then printed.) 2, The completed form(s) should be submitted in hardcopy in accord with the existing iL Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk. DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive Information.' If you have any problems accessing these forms, please contact Nicole Williams at (703} 308-5551 or by e-mail at williams.nicole@epa.gov. The following Agency Pesticide Registration Forms are currently available via the internet: at the following locations: 8570-1 8570-4 Application for Pesticide Registration/Amendment Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-l.pdf http://www.epa.gov/opprd001/forms/8570-4.pdf 223 ------- 8570-5 8570-17 8570-25 8570-27 8570-28 8570-30 8570-32 8570-34 8570-35 8570-36 8570-37 Notice of Supplemental Registration of Distribution of a Registered Pesticide Product Application for an Experimental Use Permit Application for/Notification of State Registration of a Pesticide To Meet a Special Local Need Formulator's Exemption Statement Certification of Compliance with Data Gap Procedures Pesticide Registration Maintenance Fee Filing Certification of Attempt to Enter into an Agreement with other Registrants for Development of Data Certification with Respect to Citations of Data (PR Notice 98-5) Data Matrix (PR Notice 98-5) Summary of the Physical/Chemical Properties (PR Notice 98-1) Self-Certification Statement for the Physical/Chemical Properties (PR Notice 98-1) http://www.epa.gov/opprd001/forms/8570-5.pdf http://www.epa.gov/opprd001/forms/8570-17.pdf http://www.epa.gov/opprd001/forms/8570-25.pdf http://www.epa.gov/opprd001/forms/8570-27.pdf http://www.epa.gov/opprd001/forms/8570-28.pdf http://www.epa.sov/opprd001/forms/8570-30.pdf http://www.epa.sov/opprd001/forms/8570-32.pdf http://www.epa.gov/opppmsdl/PR Notices/pr98-5 .pdf http://www.epa.gov/opppmsdl/PR Notices/pr98-5 .pdf http ://www. epa. sov/opppmsd I/PR Notices/pr98- 1 .pdf http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf Pesticide Registration Kit www.epa.sov/pesticides/resistrationkit/ Dear Registrant: For your convenience, we have assembled an online registration kit which contains the following pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP): 224 ------- 1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA)of 1996. 2. Pesticide Registration (PR) Notices a. 83-3 Label Improvement Program-Storage and Disposal Statements b. 84-1 Clarification of Label Improvement Program c. 86-5 Standard Format for Data Submitted under FIFRA d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation) e. 87-6 Inert Ingredients in Pesticide Products Policy Statement f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF format and requires the Acrobat reader.) Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices 3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require the Acrobat reader). a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment b. EPA Form No. 8570-4, Confidential Statement of Formula c. EPA Form No. 8570-27, Formulator's Exemption Statement d. EPA Form No. 8570-34, Certification with Respect to Citations of Data e. EPA Form No. 8570-35, Data Matrix 4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat reader). a. Registration Division Personnel Contact List a. Biopesticides and Pollution Prevention Division (BPPD) Contacts b. Antimicrobials Division Organizational Structure/Contact List 225 ------- d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format) e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format) f 40 CFR Part 158, Data Requirements for Registration (PDF format) g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985) Before submitting your application for registration, you may wish to consult some additional sources of information. These include: 1. The Office of Pesticide Programs' website. 2. The booklet "General Information on Applying for Registration of Pesticides in the United States", PB92-221811, available through the National Technical Information Service (NTIS) at the following address: National Technical Information Service (NTIS) 5285 Port Royal Road Springfield, VA 22161 The telephone number for NTIS is (703) 605-6000. 3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or through their website. 4. The National Pesticide Telecommunications Network (NPTN) can provide information on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through their website: ace.orst.edu/info/nptn. The Agency will return a notice of receipt of an application for registration or amended registration, experimental use permit, or amendment to a petition if the applicant or 226 ------- petitioner encloses with his submission a stamped, self-addressed postcard. The postcard must contain the following entries to be completed by OPP: a. Date of receipt; b. EPA identifying number; and c. Product Manager assignment. Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying file symbol or petition number for the new submission. The identifying number should be used whenever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition. To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please include a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical (including "blind" codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a chemical abstract system (CAS) number if one has been assigned. 227 ------- Appendix I. List of Available Related Documents and Electronically Available Forms Pesticide Registration Forms are available at the following EPA internet site: http://www.epa.gov/opprd001/fortns/ Instructions 1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your computer then printed.) 2. The completed form(s) should be submitted in hardcopy in accord with the existing policy. 3. Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk. DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive Information.' If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by e-mail at williams.nicole@epa.gov. The following Agency Pesticide Registration Forms are currently available via the internet: 8570-1 Application for Pesticide http://www.epa.gov/opprd001/forms/8570-l.pdf Registration/Amendment 8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf 8570-5 Notice of Supplemental Registration of http://www.epa.gov/opprd001/forms/8570-5.pdf Distribution of a Registered Pesticide Product 8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf 8570-25 Application for/Notification of State http://www.epa.gov/opprd001/forms/8570-25.pdf Registration of a Pesticide To Meet a Special Local Need 228 ------- 8570-27 Formulator's Exemption Statement 8570-28 Certification of Compliance with Data Gap Procedures 8570-30 Pesticide Registration Maintenance Fee Filing. 8570-32 Certification of Attempt to Enter into an Agreement with other Registrants for Development of Data 8570-34 Certification with Respect to Citations of Data (PR Notice 98-5) 8570-35 Data Matrix (PR Notice 98-5) 8570-36 Summary of the Physical/Chemical Properties (PR Notice 98-1) 8570-37 Self-Certification Statement for the Physical/Chemical Properties (PR Notice 98-1) http://www.epa.gov/opprd001/forms/8570-27.pdf http://www.epa.gov/opprd001/forms/8570-28.pdf http://www.epa.gov/opprd001/forms/8570-30.pdf http://www.epa.gov/opprd001/forms/8570-32.pdf http://www.epa. gov/opppmsdl/PR_Notices/pr98- 5.pdf http://www.epa. gov/opppmsdl/PR_Notices/pr98- 5.pdf http://www.epa. go v/opppmsdl/PR_Notices/pr9 8- l.pdf http://www.epa. go v/opppmsdl/PR_Notices/pr9 8- l.pdf Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/ Dear Registrant: For your convenience, we have assembled an online registration kit which contains the following pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP): 1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996. 2. Pesticide Registration (PR) Notices a. 83-3 Label Improvement Program - Storage and Disposal Statements b. 84-1 Clarification of Label Improvement Program c. 86-5 Standard Format for Data Submitted under FIFRA d. 87-1 Label Improvement Program for Pesticides Applied Through Irrigation Systems (Chemigation) e. 87-6 Inert Ingredients in Pesticide Products Policy Statement f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 229 ------- g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF format and requires Acrobat reader.) Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_NoticesPesticide Product Registration Application Forms (These forms are in PDF format and will require the Acrobat reader). a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment b. EPA Form No. 8570-4, Confidential Statement of Formula c. EPA Form No. 8570-27, Formulator's Exemption Statement d. EPA Form No. 8570-34, Certification with Respect to Citations of Data e. EPA Form No. 8570-35, Data Matrix 4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat reader). a. Registration Division Personnel Contact List b. Biopesticides and Pollution Prevention Division (BPPD) Contacts c. Antimicrobials Division Organizational Structure/Contact List d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format) e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format) f 40 CFR Part 158, Data Requirements for Registration (PDF format) g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985) Before submitting your application for registration, you may wish to consult some additional sources of information. These include: 1. The Office of Pesticide Programs' website. 2. The booklet "General Information on Applying for Registration of Pesticides in the United States", PB92-221811, available through the National Technical Information Service (NTIS) at the following address: National Technical Information Service (NTIS) 230 ------- 5285 Port Royal Road Springfield, VA 22161 The telephone number for NTIS is (703) 605-6000. 3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494- 6614 or through their website. 4. The National Pesticide Telecommunications Network (NPTN) can provide information on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through their website: ace.orst.edu/info/nptn. The Agency will return a notice of receipt of an application for registration or amended registration, experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his submission a stamped, self-addressed postcard. The postcard must contain the following entries to be completed by OPP: 1. Date of receipt; 2. EPA identifying number; and 3. Product Manager assignment. Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying file symbol or petition number for the new submission. The identifying number should be used whenever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition. To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please include a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical (including "blind" codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a chemical abstract system (CAS) number if one has been assigned. 231 ------- 232 ------- |