Reregistration Eligibility Decision (RED): Cytokinin

United States Environmental Protection Agency ~ Prevention, Pesticides And Toxic Substances (7501W) EPA-738-F-95-Q3O December 1995 R.E.D. FACTS Pesticide Reregistration Cytokinin All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides which were first registered before November 1, 1984, be reregistered to ensure that they meet today's more stringent standards. • In evaluating pesticides for reregistratiori, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human , health and environmental effects of each pesticide. The Agency develops any mitigation measures or regulatory controls needed to effectively reduce each pesticide's risks. EPA then reregisters pesticides that can be used without posing unreasonable risks to human health or the environment. When a pesticide is eligible for reregistration, EPA explains the basis for its decision in a Reregistration Eligibility Decision (RED) document. iThis feet sheet summarizes the information hi the RED document for reregistration case number 4107, Cytokinm. Use Profile Cytokinin is a group of plant regulators that promote cell division, leaf expansion and retard leaf agmg/Cytokinin is applied to growing crops (field crops, vegetable crops, small fruits, vines and tree fruit), young trees, ornamentals, and golf courses to increase fruit size, yield, blossoms, ; branching, healthy appearance, and other desirable growth effects. Cytokinin is comprised of four naturally occurring cytokinins derived from aqueous extract of seaweed meal ~ zeatin [6-(4-hydroxy-3-methylbut-trans- 2-enylamjno)-purine], N6-methylaminopurine, N^-dunethylaminopurine, and N6-isopentenylaminopurine.-- and synthetic cytokinin — kinetin [6- (furfurylamino)purine]. Cytokinins (i.e. naturally occurring) in aqueous extracts of seaweed meal, are derived from the following algae: Laminaria digitaia, Laminaria hyperborea, Fucus serratus and Ascophyllum nodosum. Several, if not all of these species of algal species are consumed by man and/or livestock. The extracts from these plant species (e.g. the naturally occurring Cytokinins) are exempt from the requirements of tolerances when used as plant regulators in or on many raw agricultural commodities (40 CFR 180.1042). ------- Formulation Types Registered: Formulations include a soluble concentrate/liquid (manufacturing use product), and flowable concentrate, soluble concentrate/liquid, ready-to-use liquid (end use products). Methods and Rates of Application: Cytokinin may be applied by aircraft, irrigation system, ground spray equipment, seed treatment, or soil incorporation. Use Practice Limitations: Preharvest Intervals of 14 or 21 .days may be required, depending on the crop. , The Use Practice Limitations listed below do not apply .to all uses on all products: "Do not allow rinse water to contaminate streams, ponds and lakes, as water life may be endangered." "Do not apply through any type of irrigation system." "Do not apply to any body of water." ."For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high watermark." ."'.'. > "Do not connect an irrigation system (including greenhouse systems) used for pesticide application to public water system unless the pesticide label-prescribed safety devices for public water systems are in place." ReaillatorV HiStorV Plant grow* regulator, Cytokinin, was initially registered in the United Sjates ih 1978 M dYTEX* <£PA *• No- 35980-1) for ^Plications to certain citrus, fruit and vegetable crops. Cytokinin acts as a plant ' regulator by promoting cell division; mimmizuig effects of stress; stimulating roots; increasing yield; increasing vegetative growth; and increasing tuber firmness. During Phase 4 of the accelerated pesticide reregistration process, the data base for Cytokinin was evaluated and determined to be inadequate in satisfying certain requirements for biochemical pesticides which include plant regulators. A DCI was issued in August 1993 to fill the outstanding data gaps.. ------- Human Health Assessment Since the DCI, the Agency's initial position regarding these data gaps was re-evaluated. All of these data requirements, except a Non-target insects study, were waived because available information indicates that Cytokinin does not cause unreasonable adverse effects: (1) The principal constituents of Cytpkinin (algae and seaweed) are natural components of fish diets, (2) Cytokinin has a very low acute mammalian toxicity, (3) Cytokinin is used as a dietary supplement in animal feeds, and (4) Cytokinin pesticide products are expected to have no adverse effects to fish and wildlife. Toxicity . In studies using laboratory animals, Cytokinin generally has been shown .to be of low, acute toxicity. The acute dermal toxicity (LD50>2g/kg),. eye irritation (slight irritation), and dermal irritation (slightly irritating) place Cytokinin in Toxicity Category HI (the second lowest of four toxicity categories). Cytokinin's oral toxicity (LD50>5g/kg) places it in Toxicity Category IV (the lowest of four toxicity categories). [NOTE: For acute oral, dietary, mammalian/avian/aquatic toxicity: Category I = very highly or highly toxic , Category n = moderately toxic Category ffl == slightly toxic Category IV = practically non-toxic] Dietary Exposure Only the four naturally occurring Cytokinins,derived from, certain algal species, are exempt from the requirement of a tolerance when used as a plant growth regulator (40 CFR 180.1042). At this time, synthetic Cytokinin is not included inthis tolerance exemption. > Tolerance exemptions are often based on the results of 90-Day (or longer) feeding and developmental toxicity studies .submitted to support reregistration. However; it is the Agency's opinion that these studies can be waived for naturally occurring and synthetic Cytokinin because of low acute mammalian toxicity and very low use rates, which would not significantly increase dietary intake over natural consumption in foods. The Agency, will be proposing an exemption from the requirement of a tolerance for certain Cytokinins (zeatin I6-(4-hydroxy-3-methylbut-trans-2-enylamino)-purine], N6-methylaminopurine, N6-dimethylaminopurine, N6- isopentenylaminopurine), and synthetic cytokinin — kinetin [6- (furfurylamino)purine] for all raw agricultural commodities (RACs). The exemption will apply only when application rates do not exceed 250 grams of active ingredient/acre/year. The Agency believes this action does not present any unreasonable risk. It is based on Cytokinin's low acute ; mammalian toxicity, its low use rates, exposure in the diet from numerous ------- natural plant food sources, and minimal exposure in the diet derived from consumption of treated commodities under the proposed maximum label use rates. , • The Agency has concluded that dietary exposure risks from consuming commodities treated with Cytokinin, either naturally occurring or synthetic, are not expected. Occupational and Residential Exposure Based on the application methods listed on Cytokinin product, labels, the potential for eye, dermal and inhalation exposure to agricultural workers does exist. However, since Cytokinin is in Toxicity Categories HI and IV for acute oral, dermal, eye irritation and dermal irritation, to reduce worker exposure. The Agency has concluded that these occupational exposures and subsequent risks will be negligible because of Cytokinin's low acute mammalian toxicity and low use rates. Also, the precautionary product labeling stipulated in the RED document will sufficiently mitigate exposures and any subsequent risks to agricultural workers. Human Risk Assessment Since exposures and subsequent risks from Cytokinin applications are not expected, any potential risks from exposure to treated plants will be mitigated by the use of personal protective equipment required by the Worker Protection Standard, supplemented by specific precautionary labeling required by this RED. Post-application reentry workers are required to observe a 12 hour Restricted Entry Interval. Because of Cytokiniri's ubiquitous nature and low toxicity, however, it is a candidate for a reduced reentry interval: from 12 hours to 4 fours. • Environmental Assessment Based on a review of all available ecological data, exposure information, and Cytokinin's non-toxic mode of action, the Agency expects that applications of Cytokinin will pose minimal risk to nontarget wildlife and fish. Environmental fete studies for biochemicals are not imposed unless adverse effects are observed in ecological effects data. Since no adverse effects are anticipated, the Agency will not, at this time, impose any environmental fete data requirements for the currently registered uses of Cytokinin. ------- Additional Data EPA is requiring a revised Confidential Statements of Formula (CSFs) Required an(^ revised product labeling for reregistration. Product Labeling Changes Required The Agency has reexamined the toxicological data base for Cytokinin concluded that the current precautionary labeling (i.e. Signal Word, Statement of Practical Treatment, WPS required labeling, and other label statements associated with mitigating risks) adequately mitigate any risks associated with the use of this plant growth regulator. Regulatory Conclusion Based on the reviews of the generic data for Cytokinin, the Agency has sufficient information on health effects and the potential for causing adverse effects in fish and wildlife. The Agency has determined that products containing Cytokinin, when labeled and used as specified in this RED, will not pose unreasonable risks or adverse effects .to humans or the environment. Therefore, the Agency concludes that products containing Cytokinin for certain uses that have a tolerance exemption (i.e. food uses/commodities listed in 40 CFR 180.1042) are eligible for reregistration. Other food uses of Cytokinin which do not have an exemption from tolerance requirements (i.e. -, those food uses/commodities not listed in 40 CFR 180.1042) will become eligible for reregistration only when a tolerance exemption is issued and becomes a final rule. The Agency plans to propose such an exemption and pending public comment, issue a final rule in early 1996. r'-. For More Information EPA is requesting public comments on the Reregistration Eligibility Decision (RED) document for Cytokinin during a 60-day time period, as announced in a Notice of Availability published in the Federal Register. To obtain a copy of the RED document or to submit written comments, please contact the Pesticide Docket,,Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805. Electronic copies of the RED and this feet sheet can be downloaded from the Pesticide SpeciaHteview and Reregistration Information System at 703-308-7224. They also are available on the Internet on EPA's gopher server, GOPHER.EPA. GOV, or using ftp on FTP.EPA. GOV, or using WWW (World Wide Web) on WWW.EPA.GOV. Printed copies ofihe RED and fact sheet can be obtained from EPA's National Center for Environmental Publications and Information , (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-489-8190, fax 513-489-8695. ------- . Following the .comment period, the Cytokinin RED document also will be available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. For mote information about EPA's pesticide reregistration program, the Cytokrnin RED, or reregistration of individual products containing Cytokinin, please contact the Biopesticides and Pollution Prevention Division (7501W), OPP, US EPA, Washington, DC 20460, telephone 703- 308-8712. For information about the health effects of pesticides, or for assistance in recognizing and managing pesticide poisoning symptoms, please contact the National Pesticides Telecommunications Network (NPTN). Call toll- free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time, Monday through Friday. ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY - . '• WASHINGTON, D.C. 2Q460 . OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant: I am pleased to announce that the Environmental Protection Agency has completed its reregistration eligibility review and decisions on the biopesticide case Cytokinin, which includes the active ingredients dervied from naturally occurring Cytokinin (zeatin [6-(-4- hydroxy-3-methylbut-tKms-2^nylaminoO-purine], N6-menthylaminopurine, N6- ' dimethylaminopurine, N^-isopentenylaminopurine) and synthetic Cytokinin (Kinetin -- 6- ;(furfuryl amino) purine). The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base of these chemicals, its conclusions of the potential human health and environmental risks of the current product uses, and its decisions and conditions under which these uses and products will be eligible for reregistration. The RED includes the data and labeling requirements for products for reregistration. To assist you with a proper response, read the enclosed document entitled "Summary of Instructions for Responding to-the RED". This summary also; refers to other enclosed documents which include further instructions. You must follow all instructions and submit complete and timely responses. An Application for Reregistration is. required to be submitted eight months from the date of receipt of this letter. Complete and timely responses will avoid the Agency taking the enforcement action of suspension against your products. '•.'•'., ..'•"'.-.' ";...' If you have questions about our decision or the requirements set forth in this , document, please contact the reregistration representative for the Biopesticides and Pollution Prevent Division, Richard King at (703) 308-8052. , Sincerely yours, Janet Andersen, Acting Director Biopesticides and Pollution Prevention Division (7501W) Enclosures ------- ------- SUMMARY OF INSTRUCTIONS FOR RESPONDING TO THE REREGISTRATION ELIGIBILITY DECISION (RED) .1, DATA GALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for reregistration, a DGI letter will be enclosed describing such data. If product specific data are required, another DCI letter will be enclosed listing such requirements. If both generic and product specific data are required, a combined Generic and Product Specific letter will be enclosed describing such data. Complete the two response forms provided with each DCI letter (or four forms for the combined) by following the instructions provided. You must submit the response forms for each product and for each DCI within 90 days of the date of this letter (RED issuance date); otherwise, your product may be suspended. 2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests will be granted for the 90-day response. Time extension requests may be submitted only with respect to actual data submissions. Requests for data waivers must be submitted as part of the 90-day response. Requests for time extensions should be submitted in the 90-day response, but certainly no later than the 8-month response date. All data waiver and time extension requests must be accompanied by a full justification. All waivers and time extensions must be granted by EPA in order to go into effect. ' 3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must submit the following items for each product within eight months of. the date of this letter .(RED issuance date). •.•'- - t . ' ' - • -,.•".'.-• .a. Application for Reregistration (EPA Form 8570-1). Use only an original application form. Mark it "Application for Reregistration." Send your Application for Reregistration (along with the other forms listed in b-e below) to the address listed in item 5. b. Five copies of draft labeling which complies with the RED and current regulations and requirements. Only make labeling changes which are required by the RED and current regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation changes, or labeUng changes not related to reregistration) separately. You may delete uses which the RED says are ineligible for reregistration. For further labeling guidance, refer to the labeling section of the EPA publication "General Information on Applying for Registration in the U.S., Second Edition, August 1992" (available from the National Technical Information Service, publication #PB92-221811; telephone number 703-487-4650). c. Generic or Product Specific Data. Submit all data in a format which complies with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier (MRID) numbers. Before citing these studies, you must make sure that they meet the Agency's acceptance criteria (attached to the DCI). d. Two copies of the Confidential Statement of Formula (CSF) for each basic and each alternate formulation. The labeling and CSF which you submit for each product must comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration. You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR §158.175) or (2) provide certified limits mat are supported by the analysis of five batches. If you choose the second option, you must submit or cite the data for the five batches along with a certification statement as described hi 40 CFR §158.175(e). A copy of the CSF is enclosed; follow the instructions on its back. ------- e. Certification With Respect to Data Compensation Requirements. Complete and sign EPA form 8570-31 for each product. " ' 4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments pertaining to the content of the RED may.be submitted to the address shown in the Federal Register Notice which announces the availability of this RED.. 5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES) By U.S. Mail; Document Processing Desk (RED-SRRD-PRB) , Office of Pesticide Programs (7504C) • EPA, 401 M St. S.W. Washington, D.C. 20460-0001 , -, By express; . Document Processing Desk (RED-SRRD-PRB) Office of Pesticide Programs (7504C) Room 266A, Crystal Mall 2 1921 Jefferson Davis Hwy. Arlington, VA 22202 , gt EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not complete will be returned with a request for corrections. EPA will try to respond to data waiver and time extension requests within 60 days. EPA will also try to respond to all 8- month submissions with a final reregistration determination within 14 months after the RED . has been issued. ------- REREGISTRATION ELIGIBILITY DECISION CYTOKININ •\ ' > .' " LISTD .-•• : ' , ;• • \ , • .. - ~ . • * ' ' CASE4107 ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS BIOPESTICIDES AND POLLUTION PREVENTION DIVISION ------- ------- TABLE OF CONTENTS CYTQKININ REREGISTRATION ELIGIBILITY DECISION TEAM .......... ^ ... i EXECUTIVE SUMMARY . . .':. . . . u . ., ... ... .... . . . ;\ . . . .'; , v I. INTRODUCTION .... ........; . ;. ...... . .'.; .'...'.'.'.' ... ...... ... 1 H. CASE OVERVIEW . . . . . . . . .... ,..-.. . ... . . .2 A. Chemical Overview .;. . . ................. . . . 2 B. Use Profile .................... ^ ... 2 C. Estimated Usage of Pesticide . . . .'. ... . . .... . . , . . . . 5 D. Data Requirements ...............•.............;....... 6 E. Regulatory History .', ..7 m. SCIENCE ASSESSMENT . . . . . . . . ...', . . _ 8 A. Physical Chemistry Assessment......,..:. .... ... ............ . . 8 B.. Human Health Assessment...........,..../............... 8 1. , Toxicology Assessment . . ... . .... . . . . ...... ...... . . •; .8 a- Acute Tpxicity ............ r................ ; 8 2. Exposure and Risk Assessment ..................;...,.. 9 -.:•', Dietary Exposure and Risk Assessment ............ . 9 b. Occupational Exposure^d Risk Assessment . ........ 10 C. Environmental Assessment... .','. . ... .... , . . . ..'.. ... , ..... . ... . IQ 1,, EcologicalToxicity Data . ., . . . ; . . . ... , ; . . . ; ... . ,', . . . 10 2. Environmental Fate ...... i ....................... n IV. RISK MANAGEMENT AND REREGISTRATION DECISION . :, . ....... 11 A. Determination of Eligibility . . . . . . . ...." . . .....; 11 1. Eligibility Decision .......................! 1 !;! !v! 12 2. Eligible Uses .... ..v. ....................... ..;. 12 B. Regulatory Position . . .... . . . . ................'........ 14 1. Tolerance Reassessment . ;.......... 14 2. Endangered Species Statement . .....,'. .... ... ;.......... 14 3. Labeling Rationale . ..... . . :..... . . . ... . . . . , . ... . . 15 i • • • ... ' _"..'• . • . • V. ACTIONS REQUIRED BY REGISTRANTS ....,...............! 16 A. Manufacturing-Use Products ..... .................... 16 1. Additional Generic Data Requirements . ... . .','. ..... 16 2. LabeUng Requirements for Manufacturing-Use Products ...... 16 B. End-Use Products .... . . . . . . ... .... , ........ .... ...... 17 1. Additional Product-SpecificData Requirements ............ 17 ------- 2. Labeling Requirements for End-Use Products 17 C. Existing Stocks 18 VI. APPENDICES :..............:... 19 APPENDIX A. Table of Use Patterns Subject to Reregistration ....... 20 APPENDIX B. Table of the Generic Data Requirements and Studies Used to Make the Reregistration Decisiop 199 APPENDIX C. Citations Considered to be Part of the Data Base Supporting the Reregistration of Cytokmin . . . 205 APPENDIX D. , List of Available Related Documents 208 ------- CYTOKININ REREGISTRATION ELIGIBILITY DECISION TEAM Office of Pesticide Programs: Biological and Economic Analysis Division i . • - ' George Keitt EricMauer Thomas Harris Biological Analysis Branch Economic Analysis Branch Biological Analysis Branch Labeling Use Information Biopesticide and Pollution Prevention Division Clay Beegle Denise Greenway Christina Hartman (USDA-IR-4 Group) Phillip Button . Richard King J. Thomas McClintock Sheryl K. ReiUy Robert I. Rose William Schneider Roy Sjoblad JohnTice ; . > Freshteh toghrol ; Robert Torla ------- ------- GLOSSARY OF TERMS AND ABBREVIATIONS ADI AE a.i. CAS CI CNS . CSF DFR ORES DWEL EEC EP EPA FDA FIFRA FFDCA FOB GLC GM GRAS HA HOT LD« lo LD, LEL" LOG LOD LOEL MATC MCLG ug/g mg/L MOE MP MPI MRIp N/A '-.- NOEC NPDES Acceptable Daily Intake. A now defunct term for reference dose (RfD). Acid Equivalent ... Active Ingredient . Anticipated Residue Contribution Chemical Abstracts Service Cation Central Nervous System Confidential Statement of Formula • Dislodgeable Foliar Residue . . - ' Dietary Risk' Evaluation System. Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking . water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to -occur. Estimated Environmental Concentration, The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. End-Use Product ' U.S. Environmental Protection Agency Food and Drug Administration • Federal Insecticide, Fungicide, and Rcfdenticide Act , Federal Food, Drug, and Cosmetic Act Functional Observation Battery ' • . Gas Liquid Chromatography ' . . . . Geometric Mean ' . : Generally Recognized as Safe as Designated by FDA : Health Advisory (HA). The HA values are used as informal guidance to municipalities and other organizations when emergency spills or contamination situations occur. Highest Dose Tested 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/l,mg/kg or ppm. Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% s 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., nig/kg. . Lethal Dose-low. Lowest Dose at which lethality occurs. . , Lowest Effect Level • "'-' , . Level of Concern Limit of Detection Xowest Observed Effect Level , Maximum Acceptable Toxicant Concentration , , Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in drinking water urider the Safe Drinking Water Act. \ - Micrograms Per Gram .. Milligrams Per Liter • ' Margin of Exposure . , • • Manufacturing-Use Product ' , ' • ' Maximum Permissible Intake ! , ' Master Record Identification (number); EPA's system of recording and tracking studies submitted. Not Applicable No effect concentration , / - . . National Pollutant Discharge Elimination System . ' 111 ------- GLOSSARY OF TERMS['AND ABBREVIATIONS NOEL No Observed Effect Level NOAEL No Observed Adverse Effect Level '. OP Organophosphate OPP Office of Pesticide Programs " ... PAD! ' Provisional Acceptable Daily Intake •. . ' . PAG Pesticide Assessment Guideline PAM Pesticide Analytical Method - PHED Pesticide Handler's Exposure Data • , ' PHI ' Preharvest Interval .. . . ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million. • . PRN Pesticide Registration Notice Q, , The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model RBC Red Blood Cell . RED . • Reregistration Eligibility Decision • REI Restricted Entry Interval , . RfD Reference Dose, • RS Registration Standard . ' SLN Special Local Need (Registrations Under Section 24 © of FIFRA) , TC • Toxic Concentration. The concentration at which a substance produces a toxic effect: TD Toxic Dose. The dose at which a substance produces a toxic effect. . TEP Typical End-Use Product ' ( „- , TGAl Technical Grade Active Ingredient _ TLC Thin Layer Chromatography - . TMRC Theoretical Maximum Residue Contribution - torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions. FAO/WHO Food and Agriculture Organization/World Health Organization ,WP Wettable Powder WPS Worker Protection Standard IV ------- EXECUTIVE SUMMARY The Environmental Protection Agency has completed an assessment of the potential human health and environmental risks associated with the pesticidal use of Cytokinin in the United States. Cytokinin is a group of plant regulators that promote cell division, leaf expansion and retard leaf aging. Cytokinin is comprised of four naturally occurring cytokmins (derived from aqueous extract of seaweed meal) - zeatin [6-(4-hydroxy-3-methylbut-trahs-2-enylammo)-purine], N6-methylammopurine, l ------- ------- I. INTRODUCTION In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to accelerate the reregistration of products with active ingredients registered prior to November 1, 1984. The amended Act provides a schedule for the reregistration process to be completed in nine years. There are five phases to the reregistration process.. The first four phases of the-process focus on identification of data requirements to support the reregistration of an active ingredient and the generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted to support reregistration. 1 FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether pesticides containing such active ingredients are eligible for reregistration" before calling in data on products, and either reregistering products or taking "other appropriate regulatory action." Thus, reregistration involves a thorough review of the scientific data base 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 the pesticide meets the "no unreasonable adverse effects" criterion of FIFRA. This document presents the Agency's decision regarding the reregistration eligibility of the registered uses of Cytokinin. The document consists of six sections. Section I is the introduction. Section H describes Cytokinin, its uses, data requirements and regulatory history. Section m discusses .the human health and environmental assessment based on the data available to the Agency. Section IV presents the reregistration decision for Cytokinin. Section V discusses the reregistration requirements for Cytokinin. Finally, Section VI is the Appendices which support this Reregistration Eligibility Decision. Additional details concerning the Agency's review of applicable data are available on request. ------- H. CASE OVERVIEW A. Chemical Overview . , The following active ingredients) are covered by this Reregistration Eligibility Decision: Common Name: Chemical Name: Cytokinin (four naturally occurring Cytokinins derived from aqueous extract of seaweed meal) and Kinetin (synthetic Cytokinin). , Cytokinin — zeatin [6-(4-hydroxy-3-methylbut-trans-2- enylamino)-purine], N6-methylaminopurine, N6-dimethylaminopurine, N6- isopentenylaminopurine. Kmetm - 6-(furfuryl aminp) purine Chemical Family: Purine CAS Registry Number: 525-79-1 OPP Chemical Code: 116801 ' Trade and Other Names: CYTEX", Nitrozyme , CYTOGEN , and Burst Yield Booster". Basic Manufacturers: B. Use Profile Riverside/Terra Corp. Atlantic & Pacific Research Atlantic-Lab., Inc Aqua-10 Corp. * Westbridge Agricultural Products Stqller Enterprizes Inc. . P?B.T., fee. Transagra International Inc. P.B. Ohrstrom & Sons Inc. Arcadian Seaplants Ltd. The following is information on the currently registered uses with an overview of use sites and application methods. A detailed table of these use of Cytokinin is in Appendix A. For Cytokinin: ------- Type of Pesticide: Plant Regulator •Use-Sites: / ' . ..• ' ., , •..'•• V , • .".'•''.'-• '.. TERRESTRIAL FOOD CROP: anise, asparagus, banana, , broccoli, brussels sprouts,1 cabbage, carrot (including tops), catjang (Jerusalem/marble pea), cauliflower, celery, cucumber, eggplant, fennel, garbanzos (including chick peas), garlic, leek, lettuce! melons, cantaloupe, honeydew, muskmelons, watermelons, okra, onion, parsley, peach,' pepper, pepper (chili type), plantain, pumpkin, radish, shallot, spinach, squash (all or unspecified), strawberry, sweet potato, wheat, yam TERRESTRIAL FOOD+FEED CROP: apple; beans; beans, dried-type; beans, mung; beans, succulent (lima); beans, succulent (snap); beets (unspecified); citrus fruits; corn (unspecified); corn, field; corn, pop; corn, sweet; cotton (unspecified); cowpea/blackeyed pea; grapes; leafy vegetables; orange; peanuts .(unspecified); peas (unspecified); peas, field; peas, pigeon; peas, southern; potato, white/irish; rice; sorghum; sorghum (unspecified); soybeans (unspecified); sugar beet; tomato; triticale; wheat TERRESTRIAL FEED CROP: alfalfa, capes, lupine TERRJSTRIAL+GREENHOUSE FOOD CROP: asparagus; banana; beans; broccoli; broccoli, Chinese; Brussels sprouts; cabbage; carrot (including tops); cauliflower; celery; corn,pop; corn,sweet; cucumber; cucurbitvegetables; eggplant; lettuce; melons; nectarine- onion; parsley; parsley.turnip-rooted; peacji; pepper; pepper (chili type); plantain; potato, white/irish; pumpkin; radish; shallot; spinach; squash (all or unspecified); squash (winter); squash (zucchini); strawberry; sweet potato; tomato TERRESTRIAL GREENHOUSE FOOD CROP: potato, white/irish, tomato . TERRESTRIAL NON-FOOD CROPrcommerdal/industrial lawns, fruits (unspecified), golf course turf, jujube, ornamental lawns and turf, ornamental sod farm (turf), recreation area lawns, small fruits . x TERRESTRIAL NON-FOOD+OUTDOO and/or shade trees, ornamental herbaceous plants, ornamental lawns and turf, ornamental nonflowering plants, ornamental woody shrubs and vines, site term too general TERRESTRIAL GREENHOUSE NON-FOOD: ornamental and/or shade trees, ornamental herbaceous plants, ornamental woody shrubs and vines FORESTRY: forest plantings (reforestation programs), pine (forest/shelterbelt) OUTDOOR RESIDENTIAL: ornamental lawns and turf ------- INDOOR RESIDENTIAL: ornamental trees, ornamental herbaceous plants, ornamental nonflowering plants Target: Higher Plants Formulation Types Registered: MANUFACTURING PRODUCTS: -Form not identified/liquid 0.01 to 0.01% Soluble concentrate/liquid 0.0040 to 0.0120% END USE PRODUCTS: ~ Flowable concentrate 0.004 to 0.0096.% Liquid-ready to use 0.00008 to 0.00008% Soluble concentrate/liquid 0.0003 to 0.0400% Method and Rates of Application: Equipment: Aircraft. Center pivot irrigation, Dip tank, Drip irrigation, Ground, Hand move irrigation, High volume ground sprayer, Hose-end sprayer, Irrigation, Low volume ground sprayer, Mist sprayer, Moving wheel irrigation, Not on label, Pressure sprayer, Seed treater, Soil incorporation equipment, Solid set irrigation, Sprayer, Sprinkler • irrigation, Types of Treatment: Band treatment, Bark treatment, Broadcast, Chemigation, Commercially grown nursery grass sod treatment, Dip treatment. Drench, Foliar treatment, High volume spray (dilute), Low, volume spray (concentrate), Seed treatment, Soil band treatment, Soil broadcast treatment, Soil drench treatment, Soil in-rarrow treatment, Soil incorporated tteatment, Soil sidedress treatment, Spot soil treatment, Spray. ' • ; Timing: At'-first squaring (of cotton), At pegging (of peanut), At permanent flood (of .rice), At pinhead square (of cotton), At planting, Bloom, Boot, Bulbs, Containerized, Crown, Cutting, Delayed dormant, Early bloom, Early tillering, Established plantings, Fall, Foliar, Fruiting, Petal fall, Pink, Plant bed, Post-thinning,. Postemergence, Posmarvest, Postplant, Posttransplant, Prebloom, Precutting, Preharvest, Preplant, Pretransplant, Root stock, Seed piece, Spring, Tassel, Transplant, Tuber, When needed. Use Practice Limitations: Preharvest Intervals - 14 or 21 days depending on crop. Use Practice Limitations listed below do not apply to all uses on all products: ------- Do not allow rinse water to contaminate streams, ponds and lakes, as water life may be endangered. Do not apply through any type of irrigation system. Do not apply to any body of water. . ' For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.- Do not connect an irrigation system (including greenhouse systems) used for pesticide application.to public water system unless the pesticide label-prescribed safety devices for public water systems are in place. . 'V ' ; ' . . ' C. Estimated Usage of Pesticide . •(' • ' - / This section summarizes the best estimates available for the pesticide uses of Cytokinin. These estimates:are derived from a variety of published and proprietary sources available to the Agency. The data, reported on an aggregate and site (crop)l>asis, reflect annual fluctuations in use patterns as well as the variability in using data from various information sources. The table below.summarizes Cytokinin use by site. •5 '• '• ------- TABLE I: Percent of Various Crops Treated Annually with Cytokinin, 1990 -1992 •Bm«BnasHaBEEEaK Site/1 ^K-eg^Qgg9gg^ggg^ggj^^S3^^5E^3 Cotton ' Eggplant/Peppers Melons Potatoes Rice TOTALS Acres Grown/2 (OOP) . 480.2 662.9 76.482.3 * 13.230.2 72.6 408.9 622.3 1.377.9 2.983.0 58,768.3 : 474.7 17.007.0 Acres Treated (OOP) 50-75 5-50 1-5 5-55 0-1 ' 1-5 1-5 1-10' 0-1' 0 - 1 1-2 0-1 • - ' 66-211 Percent Crop Treated . 10-16 1 -8 <1-<1 0-<1 0-1 <1 - 1 0-1 0-1 0 - <1 0 - <1 0-<1 0-<1 Pounds Al Applied/3 2-5 7-66 0-<1 7-<1 0-1 0-7 1 -7 1-<1. 0 - <1 0-<1 1-<1 0-<1 19-93 /I -Site identification basedxm REFS. • •'•-•'' 12 - Acres grown based on USDA, Agricultural Census, and state statistics. - 13- Pounds AI based on .012% active ingredient in Foliar Triggrr, Data based on proprietary sources, USDA, and state statistics. - • Note- All other sites had either no known usage oiavailable data. Those with no known usage data include grapes, strawberries, onions, peaches, Brussels sprouts, cauliflower, lettuce, paisley, cucumbers, celeiy, potatoes, broccoli, cabbage spinach, carrots and asparagus. Those with no available data include bananas, squash, radish, okra, beets, peanuts, turf, and ornamental. . D. Data Requirements In Phase 4 of the Reregistration Process data gaps for Cytokinin were identified and a DCI was issued in August 1993 for studies on ecological effects, environmental fate, • and mammalian toxicity. These data were required to support the uses of products containing the active ingredients Cytokinin and Kinetin (i. e. naturally occurring and synthetic Cytokinin). Appendix B includes all data requirements identified by the Agency for currently registered.uses needed to support reregistration. • , ------- E. Regulatory History The plant regulator, Cytokinin, was initially registered in the United States in 1978 as CYTEX* (EPA Reg. No. 35980-1) for applications to certain citrus, fruit and vegetable crops. Cytokinin acts as a plant regulator by promoting cell division; minimizing effects of stress; root stimulation; increased yield; increased vegetative growth; and increased tuber firmness. During Phase 4 of the Reregistration Process, the data base for Cytokinin was evaluated and determined to be inadequate in satisfying certain requirements for biochemical pesticides which include plant regulators. The following were identified as outstanding data gaps and a DCI was issued in August 1993: 152B-12 Acute inhalation . 152B-15 Dermal sensitization 152B-17 Genotoxicity 154B-6 Avian acute pral/toxicity i54B-7a Avian dietary quail ' 154B-8a Fish toxicity-rainbow trout 154B-9 Invertebrate toxicity ^ 154B-11 Non-target insects Since the DCI, the Agency's initial position about these data gaps was re-evaluated and all of these data requirements, except for 154 B-ll Non-target insects, were waived because available information indicates Cytokinin does not cause unreasonable adverse effects: (1) The principal constituents of Cytokinin, algae and seaweed, are natural components of fish diets, (2) Cytokinin has a very low acute mammalian toxicity, (3) Cytokinin is used as a dietary supplement in animal feeds, and (4) are expected to have no adverse effects to fish and wildlife. '_..;•" During development of the reregistration eligibility decision (RED), the data requirements for non-target insect testing were re-examined and these data requirements were waived based on the previously mentioned rationale for ecological effects (i.e., low acute mammalian toxicity; use as a fish and animal food supplement; and lack of expected adverse effects to fish and wildlife). Therefore, the data are adequate to support the, currently .registered uses of Cytokinin. This Reregistration Eligibility Decision reflects a reassessment of all data which were submitted in response to the Reregistration Process. ------- HI. SCIENCE ASSESSMENT A. Physical Chemistry Assessment Below are the basic physical chemistry characteristics of Cytokinin, both naturally occurring and synthetic. B. Characteristics Color Physical State Odor Density Results Light brown Liquid No characteristic odor; "pleasant, spicy". . 1.02g/ml@20°C . . •' 4,0-. . •' .': .. '. Viscosity 27 Zahn units @ 25°C Corrosive characteristic Non-corrosive Human Health Assessment 1. Toxicology/Assessment 1 • - • \ ~> Adequate mammalian toxicology data on Cytokhiin is available and will support a Reregistration Eligibility Decision (RED). a, , Acute Toxicity Certain acute toxicity studies conducted with Cytokinin have been submitted and adequately satisfy the requirements as set forth hi 40 CFR 158.690 — Biochemical pesticides. 8 ------- TABLE II: ACUTE TOXICITY OF CYTOKININ Guideline No. 152B-10 152B-11 152B-12 152B-13 152B-14* 152B-15* 152B-16* Study Acute oral tox. (rat) Acute dermal tox. (rabbit) • Acute inhalation Eye irritation (rabbit) Dermal irritation (rabbit) Dermal sensitization Hypersensitivity Results • LD 50> 5g/kg. Dose tested 5g/kg. LD 50> 2 g/kg Waived Slight irritation Slightly irritating Waived All incidents must be reported to the Agency. Category ' 4 3 . 3 3 . MRID 00142864 00138093 00138094 00074304 , N/A N/A These data are not required to support the reregistration of the TGIA. Based on the data submitted summarized above (fable II), Cytokinin has a very low acute mammalian toxicity. Cytokinin is naturally occurring in numerous plant food sources and is a food supplement. Even with this dietary availability, no adverse effects have been reported to the Agency. The following[guideline requirements have been waived: 152B-12 — Acute inhalation; 1528^15 Dermal sensitization. All incidents of hypersensitivity must be reported to the Agency, At this time, it is the Agency's opinion that the toxicology data are adequate for reregistration of Cytokinin. . " .Exposure and Risk Assessment a. Dietary Exposure and Risk Assessment Only the four naturally occurring Cytokinins, derived:from certain algal species, are exempt from the requirement, of a tolerance when used as a plant growth regulator (40 CFR 180.1042). At this time, synthetic Cytokinin is not included in this tolerance exemption. Tolerance exemptions are often based on the results of 90-Day (or longer) feeding and developmental toxicity studies submitted to support reregistration. However, it is the Agency's opinion that these studies can be waived for naturally occurring and synthetic Cytokinin because of low acute mammalian toxicity and very low use rates which would not ------- significantly increase dietary intake over natural consumption in foods, in The Agency, will be proposing an exemption from the requirements of a tolerance for certain Cytokinins (zeatin [6-(4-hydroxy-3-methylbut-trans-2- enylamino)-purine], h^-methylaminopurine, N6-dimethylaiminopurine, N6- isopentenylaminopurine), and synthetic cytokmin — kinetin [6- (furfurylamino)purine] for all raw agricultural commodities (RACs). The exemption will apply only when application rates do not exceed 250 grams of a.i./acre/year. The Agency believes this action does not present unreasonable risk. It is based on low acute mammalian toxicity, low use rates, exposure in the diet from numerous natural plant food sources, and minimal exposure-in the diet derived from consumption of treated commodities under the proposed maximum label use rates. The Agency has concluded that the risks ;from dietary exposure derived from consuming commodities that were treated with Cytokinin, either naturally occurring or synthetic, are not expected. b. Occupational Exposure and Risk Assessment Based on the application methods listed on the product labels, the- potential for eye, dermal arid inhalation exposure to agricultural workers does exist. However, since Cytokinin is in Toxicity Categories m and IV for acute oral, dermal, eye irritation and dermal irritation, these toxicity categories, do not trigger any additional requirements for evaluation of reduction in worker exposure. The Agency has concluded that these . occupational exposures and subsequent risks will be negligible because of Cytokinin's low acute mammalian toxicity and low use rates. Also, the proposed precautionary product labeling stipulated in Section V will sufficiently mitigate exposures and subsequent risks to agricultural workers. C. Environmental Assessment Cytokinin is well characterized as a plant growth regulator and has been in continuous use since 1978 without any reports to the Agency of adverse effects to humans and the environment. Cytokinin is widely known to stimulate cell division and several other specific metabolic processes .in certain test systems. However, it's exact biochemical mode of action is not yet understood. 1. Ecological Toxicity Data Cytokinin is a foliar and broadcast-applied plant growth regulator. A DCI for the following set of ecological toxicity data was issued on August 3, 1993: Avian Oral Toxicity (154B-60, Avian Dietary Exposure (quail) (154B-7a), Fish 10 ------- Toxicity (154B-8a), Invertebrate Toxicity (154-B-9), and Nontarget Insect Testing (154B-11). The Agency granted waivers for the Avian Oral Toxicity (154Br6), Avian Dietary Exposure (154B-7a), Fish Toxicity 154B-8), and Invertebrate Toxicity 154B-9) on April 29, 1994. The Agency granted waivers for these studies based in part on a review of supplemental ecological toxicity data submitted in 1985 and low exposure rates (approximately 146 mg a.i./A). These data indicated mat Cytokinins were "practically non-toxic" on an acute basis to birds, freshwater fish, and freshwater invertebrates. Additional data waivers were granted for Nbntarget Insect Testing (154B-11) and Nontarget Plant Testing (154B-10) Were grant in July of 1995 as part of the RED development process utilizing the previously mentioned rationale relating to low exposure. Based on a review of all available ecological toxicity data and exposure information, the Agency expects that Cytokinins will pose a minimal risk to non-target wildlife and fish. • 2. Environmental Fate Environmental fete studies are Tier n studies for biochernicals and are not imposed unless adverse effects are observed in Tier I Environmental Data. Since no adverse ecological effects are anticipated, the Agency will not impose^ at this time, any environmental fate requirements for the currently registered uses of Cytokinin. , IV. MSK MANAGEMENT AND REREGISTRATION DECISION A. Determination of Eligibility , , Section 4(g)(2)(A) of FJFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient, whether products containing the active ingredients are eligible for reregistration. .The Agency has previously identified and required the submission of the genericTci.e. active ingredient specific) data required to support reregistration of products containing Cytokinin as the sole active ingredient, The Agency has completed its review of these generic data and has determined that the data are sufficient to^ support reregistration ,of some, uses containing Cytokiriin. Eighteen ; previously mentioned uses of Cytokinin do not have an exemption from tolerance. The Agency plans to propose an exemption from tolerance for many plant regulators, including Cytokinin, when used in low doses. Pending public comment, the Agency plans to publish a final rule in 1996. When this proposed exemption from tolerance is final, these eighteen uses of Cytokinin will be eligible for reregistration. Appendix B identifies the generic data requirements that ,the Agency reviewed as part of its determination of reregistration eligibility of Cytokinin, and lists the submitted studies that the Agency found acceptable. The data identified in Appendix B were sufficient to allow the Agency to assess the registered uses of Cytokinin which have tolerance exemption and to determine that the 11 ------- currently registered uses would not result in unreasonable adverse effects to humans and the environment. . '.-.,. The Agency made its reregistration eligibility determination based upon the target data base required for reregistration, the current guidelines for conducting acceptable studies to generate such data, published scientific literature, etc. and the data identified in Appendix B. Although the Agency has found that the currently registered uses of Cytokhiin are eligible for reregistration, it should be understood that the Agency may take appropriate regulatory action, and/or require the submission of additional data to support the registration of products containing Cytokmin, if new information comes to the Agency's attention or if the data requirements for registration (or the guidelines for generating such data) change. 1. Eligibility Decision Based on the reviews of the generic data for the active ingredients Cytokinin, the Agency has sufficient information on the health effects of Cytokinin and on its potential for causing adverse effects in fish and wildlife and the environment. The Agency has determined that Cytokinin products, labeled and used as. specified in this Reregistration Eligibility Decision, will not pose unreasonable risks or adverse effects to humans or the environment. Therefore, the Agency concludes that products containing Cytokinin for registered uses listed below are eligible for product reregistration. 2. Eligible Uses t . .-,.'' ' - The Agency has determined that the uses of Cytpkinin listed below are eligible for reregistration. . TERRESTRIAL FOOD CROP: asparagus, banana, broccoli, brussels sprouts, cabbage, carrot (including tops), cauliflower, celery, cucumber, eggplant, lettuce, melons, cantaloupe, honeydew, muskmelons, watermelons, okra, onion, parsley, . peach, pepper, pepper (chili type), radish, spinach, squash (all or unspecified), strawberry, sweet potato, wheat - TERRESTRIAL FOOD+FEED CROP: apple; beans; beans, dried-type; beans, mung; beans, succulent (lima); beans, succulent (snap); beets (unspecified); corn (unspecified); corn, field; com, pop; corn, sweet; cotton (unspecified); cowpea/blackeyed pea; grapes; orange; peanuts (unspecified); peas (unspecified); peas, field; peas, pigeon; peas, southern; potato, white/Irish; rice; sorghum; sorghum (unspecified); soybeans (unspecified); sugar beet; tomato; wheat TERRESTRIAL FEED CROP: alfalfa, cowpeas 12 ------- TERRESTRIAL+GREENHOUSE FOOD CROP: asparagus; banana; beans; broccoli; Brussels sprouts; cabbage; carrot (including tops); cauliflower; celery; corn, pop; corn, sweet; cucumberjeggplant; lettuce; melons; nectarine; onion; parsley; peach; pepper; pepper (chili type); potato, white/Irish; pumpkin; radish; shallot; spinach; squash (all or unspecified); squash (winter); squash (zucchini); strawberry; sweet potato; .tomato TERRESTRIAL GREENHOUSE FOOD CROP: potato, white/Irish, tomato TERRESTRIAL NON-FOOD CROP: commercial/industrial lawns, fruits (unspecified), golf course turf, jojoba, ornamental lawns and turf, ornamental sod farm (turf), recreation area lawns, small fruits TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL: ornamental and/or shade trees, ornamental herbaceous plants, ornamental lawns and turf, ornamental nonflowering plants, ornamental woody shrubs and vines TERRESTRIAL GREENHOUSE NON-FOOD: ornamental shade trees, ornamental herbaceous plants, ornamental woody, shrubs and vines FORESTRY: forest plantings (reforestation programs), pine (forest/shelterbelt) OUTDOOR RESIDENTIAL:ornamental lawns and turf INDOOR RESIDENTIAL: ornamental and/or shade trees, ornamental herbaceous plants, ornamental nopflowering plants The following 18 uses of Cytokinin do not have a tolerance or tolerance exemption from the requirements of a tolerance. The Agency plans to propose such an exemption in from tolerance for Cytokinin in 1996 and, pending public comment, issue a final rule. Anise Catjang Chinese broccoli Citrus, fruits Garbanzos beans Garlic Leafy vegetables 'Leeks , Cucurbit vegetables Lupines Fennel Nectarines Plantains Pumpkins Shallots Triticale Turnips Yams B. Regulatory Position 13 ------- ' " -The following is a summary of the regulatory positions and rationales for Cytokinin. Where labeling revisions are imposed, specific language is set forth in Section V of this document. 1. Tolerance Reassessment Cytokinins (i.e. naturally occurring) hi aqueous extracts of seaweed meal, are derived from the following algae: Lamnaria digitata, Laminaria hyperborea, Fucus serratus and Ascophyllwn nodosum. Several, if not all of-these species of algal species are consumed by man and/or livestock. The extracts from these plant species are exempt from the requirements of tolerances when used as plant regulators in or on many raw agricultural commodities (40 CFR 180.1042). Under the provisions of this tolerance exemption (40 CFR 180.1042), synthetic Cytokinin - Mnetin is not exempted from the requirements of a tolerance. The Agency plans to propose to exempt from the requirement of a tolerance, ten plant regulators, including Cytokinin (i.e. both naturally occurring and synthetic), for all RACs. This exemption is based on the plant growth regulator's low use rates, natural exposure in the diet from numerous plant food sources, minimal anticipated increase in dietary exposure over the naturally . occurring exposure in the diet when using the maximum label .rates, and low mammalian toxicity. Naturally occurring Cytokinin (zeatin, N6-methylaminopurine, ft•-_ dimethylaminopurine, and r^-isopentenylaminopurine), and synthetic Cytokinin - kinetin will be exempt from the requirements of a tolerance when applied to growing crops (all RACs) at application rates not exceeding 250 grams/acre/year once the proposed tolerance exemption for plant growth regulators becomes a final rule. • ! 2. Endangered Species Statement Based on the current use patterns, the potential for adverse effects to endangered plant and animal species from applications of Cytokinin is not expected. . .3. Labeling Rationale . Precautionary Labeling: The Agency has reexamined the toxicological data base for Cytokinhi arid concluded mat the current precautionary labeling (i.e. Signal Word, Statement. of Practical Treatment, and other label statements 14 ------- associated with mitigating risks) adequately mitigate the risks associated with the use of this plant regulator. Workers Prptection Requirements: The 1992 Worker Protection Standards for Agricultural Pesticides (WPS) established certain workers-protection requirements (personal protective equipment, restricted entry intervals, etc.) to be specified on the label of all products that contain uses within the scope of WPS. Uses within the scope of the WPS include all commercial (non-homeowner) and research uses on farms, forests, nurseries, and greenhouses to produce agricultural plants (including food, feed, and fiber plants, trees, turf grasses, flowers, shrubs, ornamental, and seedlings). Uses within the scope include not only uses on plants, but also uses on soil or planting medium the plants are (or will be) grown in. At this time all currently registered uses of.Cytokinin, except for golf course uses (greens, fairways, and tees), are within the scope of the Worker Protection Standards for Agricultural Pesticides. Any product whose labeling reasonably permits use in the production of an agricultural plant on any farm, forest, nursery, or greenhouse must comply with the labeling requirements of PR Notice 93-7, '^Labeling Revisions Required by the Worker Protection Standards WPS)", and PR Notice 93-7 and 93-11 are to be on the product label exactly as instructed in those notices, , On April 25, 1995, the Agency established a policy which allows registrants to reduce the interim WPS restricted entry interval (REI) from 12 hours to 4 hours for certain low risk pesticides. This policy identifies Cytokinin as a candidate eligible for a reduced WPS REI. The procedures for requesting a reduction in the REJ are outlined in Section V. Personal Protective Equipment (PPE); - 7.'- - ' All PPE labeling requirements for products containing Cytokinin were established using the process described hi PR Notice 93-7 or more recent EPA guidelines. This RED will not impose any changes to the PPE WPS labeling requirements established in PR Notices 93-7 and 93-11.. Restricted-Entry Intervals REI): , Under the WPS, interim REI for all uses within the scope of the WPS were established on the basis of the acute mammalian toxicity of the active ingredient. The toxicity categories of the active ingredient for acute 15 ------- dermal toxicity, 'eye irritation potential, and skin irritation potential were used to determine the interim WPS REI. If one or more of the three8 toxicity categories is classified as toxicity category I, the interim WPS REI is established at 48 hours. If none of the acute toxicity effects are in , category I, but one or more of the three is classified as category HI, the interim WPS REI is established at 24 hours. If none of the three acute toxicity effects are in category I or n, the interim WPS REI is established at 12 hours. The interim WPS REI for Cytokinin is 12 hours, since all of the acute toxicity categories are either HI or IV. V. ACTIONS REQUIRED BY REGISTRANTS This section specifies the data requirements and responses necessary for the reregistration of both manufacturing-use and end-use products. A. Manufacturing-Use Products 1. Additional Generic Data Requirements The generic, data base supporting the reregistration of Cytokinin for the above eligible uses has been reviewed and determined to be substantially complete. At this time, no additional data are being required. However, the Agency is requiring that a revised Confidential Statement of Formula (CSF) and revised product labeling be submitted within eight months of the issuance of this document. 2. Labeling Requirements for Manufacturing-Use Products At this time, no additional labeling requirements are being imposed on manufacturing use products containing Cytokinin as an active ingredient. B. End-Use Products . 1. Additional Product-Specific Data Requirements ' ' Section 4(g)(2)(B) of EEFRA calls for the Agency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. However, th'e data base supporting the reregistration of the above eligible end-uses of Cytokinin is substantially complete and no additional product specific data is being required at this time. However, the Agency is requiring that . a revised Confidential Statement of Formula (CSF) and revised product labeling be submitted within eight months of the issuance of this document. "2. Labeling Requirements for End-Use Products 16 ------- Worker Protection Standard Labeling: The interim WPS REI for Cytokinin is 12 hours and is based on acute mammalian toxicity. The Agency has determined that the interim REI of 12 hours may, in certain circumstances, be reduced to 4 hours for pesticides with low acute mammalian toxicity. Cytokinin is a candidate for a reduced REI. If registrants of Cytokinin wish their product to be considered for a REI reduction from 12 hours to 4 hours, they must notify the Agency. For. each product, the following information must be submitted: . 1. An application for Reregistration (EPA Form 8570-1). 2. One copy of the current product label, clearly marked to highlight the interim WPS REI. 3. Two copies of the revised label, clearly marked to highlight the revised WPS REI. , * 4. The following certification statement: - 1 .,—•'•" • • .=-. ' "I certify that this notification is complete in accordance with the provisions of the Agency's reduced REI Policy and that no other changes have been made to the labeling or confidential statement of formula of this product. I further understand that if this notification does not comply with the terms of the Agency's reduced REI Policy, this prqduct may be in violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and I may be 1 subject to enforcement action and penalties under Sections 12 and 14 of FIFRA. I understand that the Agency may direct a change in the REI of a ' product if the Agency determines mat a change is appropriate, and that products may be subject to regulatory and enforcement action if the appropriate changes are not made." Notifications should be sent to: ','.'' : ' '' ' - , ' I ' • , •'''•..- ByU.S. Mail: ' ' • "'"•';''.' • ' Document Processing Desk (WPS:95-1)(BPPD) Office of Pesticide Programs (7504W). Environmental Protection Agency 401 M Street, S.W. f . Washington, DC 20460-0001 " By Express: 17 ------- Document Processing Desk (WPS:95-i)(BPPD) Office of Pesticide Programs (7504W) Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 C. Existing Stocks Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from the date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the registrant may generally distribute or sell such products for 50 months from the date of the issuance of this RED. However, existing stocks time frames will be established case-by-case, depending on the number of products involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register, Volume 56, No. 123, June 26, 1991. The Agency has determined that registrants may distribute and sell Cytokinin products bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant may distribute or sell such products for 50 months from the date of the issuance of this RED. Registrants and persons other than registrants remain obligated to meet pre-existing Agency imposed label changes and existing stocks requirements applicable to products they sell or distribute. 18 ------- VI. APPENDICES 19 ------- ------- fl a) e -a •a o J o B rH •rl ID JJ ra . H O 3 a e • 010 o <1> a— u oi #o8\|. ji-aafl, d o u' s s° , p 1' .I- rH 0) ,0) tH.AJ OS 5§1 ; -5SSJ3 , as" o ra . I , * 55' n-t c . tW O w rH "A •« -o pe, Application on Equipment - imicrobial only ctor (Antimicrol < >I.H JJ (0 PjJ B 6. B U-0, 54i g1 •H f-t \| H EH CO O H" . 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B ** s ; ' ' f I ' : ' . ,'g t g § -B- g g g g !'&• ------- • \| s 19 1 CM CO M g ! i H a M 4* 1 Dats: 02/09/96 - Data: 03/03/95 (J Jj £ 3 c c u r r S ] " 1 i I 'I gil 3 .30 1 J5 ii' . 13 i i j ;* 06 a H &fc^ illi >~ 4 i s B O 5 g ~y lls^ §.f e ii'nS b"E §L" «3 ^ "" X p, « if s\| r-4 • " e jSS-s &" XI B £ iH O \|° lap . e « i 1533 n i £ oj tu o icatioo ant - al only) t £ timicrobial cation Type, Appl Application Equipl Type (Antinicrobii .encing Factor (An 1\|IS (0 . • • ' 1 c M p >™. 5 - < $ . • - .. ' • in in in in M ' .H m m • • g i i ^ t - - • , g .2^B& is • §, " « !•• ^ II-- "-«•§= n ,j 8 k— p, ^ S $8S!^« g S jj 7) O ,- f-l H M -Vl ^; «J ' 5J "- " 2 m b oocucu 'Ssi y ^ \| & &' & & & '& & 'E -a -o, 1 a 1 -1 a fi 1 I 1' I i , • in in -in ' in 00 00 . 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N. 18 5S SS rp g!:i •rt § O U rt R-3 B "I ill •H (H «r4 JJ Pi u O lilt in in in in o o o o in m in o o o ,n ,w • -g o •a a- a a I § .8 H v> • o a B- g g in in. g a a. 8 .a -B .~« g a-: a- a- -s B -B 2rt B B B'- Srt .B g § o g fi 8 ' "8 ML! ^ :'}'' $} 43 in w - •" m ' m H M ™ -3 ' . . &4! &H 00 I B ' a §: - 3' '* '- • 8 .8 c OOi . t) 01 ------- Sra •,-rt O ;•§ O i-l H •H CO U JJ O-rt 5 gr4-H •H g rt JJ •3 ""TJ S IIF -a o H - j-gS a^s-s ^ss6- §3-2 •H M OJ-H TE App Timing, Surface cy Infl on.'t • g tn:w g g S. '•'* i • b] kl o •• O . o. in ' r* g ID gti 82 o u O H ^•"r^ 81. r~i §St S r-H 13 ininin' .0 o o CO W a -Si g g g .g g g', .§ .g g g £' § 8 • 8. 8 • 8.'8'.: --c 1 - CO W .a . a .-• g-. a B- B B B B B g; g .g 8* . 8* CO a « o\ g . g g :g fi ------- 3 8 O t-« ** jl i N to a a 1 « \| 1 u> 1 fft o\ So "V ^m. O O 23 as u W • af I 3 , \| C • U T V r S 1 4107lCytokiaia] Cb i «§ l3 I ti 1 J3 ) 4 nd I! • a a&il fas- if! "J^:^ « p O o g a ill!! ts tj IB X a« X X H O »<» X O r-4 • • «> •H X X l 5** P1" •* w • 5 » § X B« 19 A £ ft o I • one ^. I A- ^•1 HI O •H Ijlll 11^ S Application Type, ing, Application E face Type (Mtimic Influencing • -actor §II& in • 1 i 'FEED USES (cori't) \| § ' in in '• in "1 o o o o TO M TO TO K Si S K £p. \|s s § a ; i vr g & i ? , \ " a . \| « • g § g ' 1 \| „ TO TO g Nv £ B B • B B - . g ;»j r> i: • •'•'' : P • • t' ' :" a a • a a • f ' W W W W K c If O , ' ^ cZ- jj . O k o tn JJ c ; i: - i i § 1 § 5 I 1 r^ H a o -^ K- a o • rl ra ^JJ x) -xi o i * § e S "* ««? OJ 1 §i § & 6 !'!" § a a i ° in •5: 1 . -S c B o ^ 4J MO "O O M \| § "V SU » k? iJ §2 gg -S S?* MO O O HH HJJ tea on oo oo oo •S UiH COCO W tO UK ,' ' s ' a ' B .' B a a a ' 2 a ' a rN w 55N w p»rtiHEJ gggggg g g g g g a ' • a • - a § a . • a a ,a .-a g g g - g g B-. 'B' B B -B rnrn CO W t/5 CO CO-CQCOCO a a a s- a a a a a a B 3* TS-* B -fl-. 2- B J .B B in ' in in in »H / o o -o o it 11- o ia ' ta H w in «H «-f «H rH O in m" . in ' m o ca • o « w o '-.:'' r' -•g -g 'g- g g g- g g g'-g 1- g "g. 1 -g .8 1 i S-'S Hj 1 1 • i \4 ft o rt , d ------- '«) : ro ;g a E •1 &' I 1! ------- in 10 o o 'a- § -a § . r- s -a a -a.B B ' a .'a o) B I Tiro Det«s 02/09/^6 Datoi 03/03/95 cil -'B a ^•%-s tH JJ B 2g? 3 >, catibn Typo, Application Application Equipment - Typo (Antimicrobial only) Mocing Factor (Antimicrob fi E r!^ 3 tt a, en ,Z * B g B ' B W 2 1 B g . TO S B g g 'B'. g' . g a-- ,^» " ' 0 w en 8 . ,co •'8 g- to. 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SI a 3&% m a' -i ll S 3 0 Sxxl a 1 s I . a • 1 w in g men • 85 , 6 S3 w ss gg •S3S I 83 M-l O "d ui e .u, m in in ' in , in in in in in "\ V\ "] oo d o o o doooo o o o o o o 55 . m m n n » a . a- a.- a • -a s ' § . § § B' • a a. a .a. .a § § § § § •§. § g § to ••» ca ra n ffl S3 is Si & & & ** * - a . a .a a. - § .a .a a -..a a a B a --a.- B .a.• -a ••" rt .« .* . * * « '-* -^ * a .B B B B B .B .'B "B B B B. B_ B B g '§ g- fi • -S . 8 - -8 -8 i c i.i S . u ti £ HUM ^!B Dn.ii iji jj fti^ C C > G CJ 9 . "C- ! O S >1 -3 U 0) rH 9 I" I S 2 S 2 . H 5 . 8 \|» § 86888.8 - r^ I~l I—« IW • r-i iw • • " r§ gi gg rg 3 S 3 CO 3 K S U OQ OO OO O-H j ,5 >q CK »JP< Kirt ------- JJ - 2n ft 0) o B -a 0) -H O a J u • .« -.C* o •H id 4J D] •as •rl E ' 3 ' u a. o id — 61 .8,27 a i >;" O i-l o S i-<45 •H g id oJ •H PI-H c a-H a < H O M d o — a O-rl C •H fH O -H B-H §3 EH C in in tn in o , , o - o o in in in in in in in o' o CD o o o . o a a B :B B B I 1 I CO ------- i ill 09/96 03/95 SS .3 U B ss fil x>— -- as 1111 1° B . S - y) licatio ipaent obial onl (Antini c or »H a l in o tn in • * O O g g § g g g co S toco S S en 2 VO -g g .g g g B B g g g g •B.'-a* B a% O ' O 1 1 01 • o\ in • tn g g- . in o i , o . o .i A < fH O 1 m in CO CO rH CO S S ' • S B B B 5-- 0 U in fiJS- g U O U to co co § •H , Jj g, n •d .0) y . I JJ g, 1 K 0 > a 1 3 O! o ca g •H 4J (0 5- •H H u'o toca I p g fe I s-s o iH n S '•& " 1 a I •fi 1 i. I iH rH O , O tu b O C ^1 O ^3 5S id rt a . tncnitfcnW i jijjj H a ------- rt 4J ra -H (D II) B 13 •H «j J 0) So •H O •H •S L O 0) nil » — _c «) 2, a-' " " W 5 S «) o a?^~ men O -H O 01 a , K c a » • O CO 47 rH « rH J3 H 0 crj C JJ O >, £ 3 O >. U S.S ro ^ * • i®£fr sll-s rH ft, <0 "iS 1.3 1 1 • JrB CO » y € - * „ ~ i * •, ''. g j -" S 1 ,- § ~- -H )h,- Postplant, Drip irrigat iofiiPii Ghemigatic in o £ '.s' g -'% -.- s .• • - '•'. J CJ CO rH ' -1 i s 03 £ Chemigatie irrigatior in in d,' d F~ ' 25 rH .§ § § § £ § ;a .';B ' „ ' .Q < - £ < in tn 0 ,0 U w o o - o o tn- tn tn in fi ' fi. Hi Hi § •H m, Posttransplant, Irrigat m, Tuber, Irrigation V^ \J 5 •H ^H 4J 4J & s, J-.-l- "•, § i ;-B i ' a-' J3 < 0 BJ o\ tn ** . ' £ j to !>. • i spray (concentrate) , Earl: r, volume ground sprayer Is '••''., ' ' • . . • • , in to in • to in d * 'd B. d CO CO O tj to 5 K " TH H S ' B • B -B .-B /B: , CO CO ' • CO . CO • CO S S3 B K Z '. •'-• ..a § 'B.. s: :B. CO CO -TO CO CO A < o .Q <: A < ja < • in . in "•v -1 in cp ..,-, o o o W cq '.cq M o o in o in . oo m in • m , u> , -v. in ' ' ' ''"• ' • • ' .- . s s .s. .«: .* •. Hi Hi J J Hi ' CJ CJ CJ CJ O'- • CO CO CO CO CO •,£ ii •H , ,-rt . rH rH ,0 0 ti tu . - ;• «? • a? ' u .u * , . o) K • H H .• O O Qi O 'O CO Si It} 3 no. 9 , a >4 D] 0) 01 rH 8 . • ••'•> !£ •- 88 • J < (^ J w co^ in > o , § a'- -a1- % B • ' a § § • § a B:" a' •••-'•:•-;•'.'• J3 «! £> Oi A S f v in O • O ' O B- ' B ri •« -in o . in m .in rH ^f m • .., -S -_'!S .'fi Hi • Hi ' ' Hi CJ ;CJ CJ CO CO CO . ' 1 •' spray (concentrate) , '• . nee, Low volume ground spra spray (concentrate) , lant. Aircraft - > § > 4J CO ------- 8. si! 0 'SJ CO r« H & vl S R <4 = 1' < § 1 i c 3 J •• or N !? " £ m Date: 02/09/56 - ' ct Date: 03/03/95 7(Cytofci&in] Onmicml : K O O i& 3 MK ( ; «H 1 «J I 5 1 M ) i. i fl Al lali • ;\|j§ B C S • a^\| ' « o e s§\| . lifil Is i "" S &° r4 • • 0 ft * y ~ 8 "5 X* C X rt 0 1 , -hi. '52 S Srt 0 "S 1 is S 8 -3 !jj! lication Type, Applica , Application Equipoen e Type (Antimicrobial luencing Factor (Antia Ifp . • , B D USES (con't) 1C c S • . . ^" m 01 to in- in in • in in - in in.'M. g in 0 B BC3 C5 0 000.0 O ig § a ' -S § 3 §^§ § 3'3§ i J. a § § § § B §§§ B. a a -B 1 .'•.-••-,'. • •'•'• \| -g § §'' a .'B 'a ' •'"§ -B- B B.. B -a '« ».' - • • i • ' • . 1' g • B 'B '§' -.B • B ' S ' B § !B . ..B § § 1 . .' ' :' J.g g g . g .- " § .B ;"; rt" i B § i ! a<- 3* a* a* '.a-. 3" B V B ' B B B .B §ui^»in^tn ^ 0 ' 0 O-O.O'O. ^ M rq w W W W T 0 ^ « 0 M 0 T o en r* o -10 o ** S u> S in , m . in i»* m t^ M , in . H tn i ' ' •'•.',- ' :>,„ . - . \| g g g' g., g ,-'g g"g g g g g .' g \|r; • '- . '•''• "' # \| g .$ g -i3- « . oi g oi 8 ...8 oi 8 8 «i,, . , • h "* "i m S U . ® ""* IT S ^S • " ^i i II 1 -i i -.'1 1 , • . « i \| \| J J i -8 . i.J \| \| 1 \| 1 PI' 3 3 \| t £ I a \| \| g y -^ §s s -^ - •&---« 22 1 ll S& i& I1 p a I 1 1 .-« : «* . : f 8g,l& 8& .8 , 8& ; ^\-S g g : \| \| • 21. * &! si & - &! 1 '" " " S S i;i\| ll ll .j.;-j\| \|\|\| I 1 :r \| II 1! II If If J ! !i !i !3J; 1 !° I! I! Is 11 • s s 11 11 II li oo ------- 4J 01 I ••• o L u / a ._ • ^ to 01 4J jj ra J>«- ' * H « SIS O .'tH a m a O M Oi < Q) Q) O * S g 4J O i B 3 O x J 'B.3.t! M O «& \|"- 4 tQ o § 12 - 0) JJ •s ------- ------- 9 H! l CM CJ CM CM m a* m • eft- CJ t> o o... ei- ' tt • n « 'CTi o\ m -o\ U. p U U S-ssi ra S Q ( • 0) O r S'cS o ! w O M Ol i) Itt ! ' * •• 5-. ° & -iySS Sg\| • 01 01 Q) (2 4J 01 j£ • a a x> S.-I o - .4J rH • 'I ' § fr .- •if I ft .fi • B B . B ' •& a- -, B';'B. §':§§• -= -B-B B . a B 'VB a ! .a . -a . a- - o -H « . . rt . 1 - •* £ D> n »H ^ -H i^ - -«H A* ^. ^ 5 a 1 's- ^ - • • (B * flJ • Qt Qi •" •rt -H. JJ i? »0 •H rH 03 01 >, g o o o o nj 3 M4 'Ul CU CU H ' O S£ 2. S.a f-i i-* O> Dt Ol (o O O - s >fo OO OO OO J rH M W CO W W S ------- «M fU s & £ N (H ft (0. I S 5 1 a g a 02/09/96 - Tina 03/03Y95 SS 88 g a „ g r- r- * t .t i t ] r c i 3 3'x gas I r-f 21 IS o 1 4 a S&§1 I y y 5 S fl M — J11, -\|$$ I«J g W Oi O iiiiS ?s s Is IV • .x a o » 9 Or* i!i\| •!!- &"~"o-3 .\|»i I \|! - i _J 5 "3 &H " n 38* 'S S * sS5 o S tu o "> • "** K a JO •r4 ~_ ja Type, Application tioa #iuipaent - ntimicrobiol only! Factor (Antimicrol B S * B> \|lf} H cn ft.uo: m i w S 3 4B 11 rTcJrJc? 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"S Tj "S-S n o 1 I 1,5 3- 5 Sfi S& S2 Si- S3 .55 35 SS ft # ------- 01 -H O D J O •O to 6 .£» x3§. 1 S 52i 5 C i * fl). ra" i I A- b i 4J 4J O-H '(0 CJ E 0 ffirH.5 §B JJ •H U 1-H -U M '{fS61' 10—0) 8 ' o in o m \ .,« o c .a » i? * -8 § a.: a-'S' •a B B 3' CO • CO CO O CJ CO CO O o •H a a § a. g, ;a g "B. -a' B a CO B 3 •* , B B • "2 * S § •H iH - XI • * 43 8 n I 4J a ------- td 3 8 S >• g 1 S 1 i S3 s w4 Type, application tton Equipment - ntiaicrobial only) Factor (Antlmicrob fill "a g"1" l\|as w ' . j. H" 1 i f 1 1 1 i ! i i : : , - .'.•'-•'- • • ' " in in ' in . in in, in in in in •' -in in inin 0-0 00 0 0000 r ; • ' • '• ;: s § a a "a § § .a § - § § a B . 3 a a a \ a a . a a a a s a K s- • [ \| B • I B -B ' B.'B; .-B B " B;B : B B S.- " - ' - i • • • ' ' ' '• ' ' \| B ' B 88. --B- B : B 8 . B • B i . • B § 3 ' 1 H g g H a '• B- .. « rt ,'" a a " § g S- S S S S S S' S ' '•; S s • g g g i g g g •a;ri in n ino g • • ' ... ' ''. '.* ' • •' : •' !"'ij k '' " ' .;..-.••'•. 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CD • G) 0) O rH I33S& 8 &5 J S O rH • .3 -• I ' rH • Q) ^) • t •HrH rH (U rH rH Cl fl rl " -H A H 4J H ,n (.4 OB O ro OO O (Q Qj COO W rH CO K W rH 6? en o\ ------- M (A s ' ss as ® -S & g t £ 8 ">! 8'51 Ifl1 Sou \|\|\|\| 5-H ff 1 s i .5 o w i^ n A P •-" J -^ CJ «,- 45 ------- 3. I ' CP o rH 3 . ^ ;>, £ * JJ H Q) \| W 4J JJ i SSS: —* 11 fl •* -.s:: ------- H I 3/9S Ch««dc ss 3S 33 ^1 a ._ jiftfil n U a Sj Jij" a^^^' ill!! ill •3-2- Illl 8 , £ S>; pa, Application on Equipoemt - imicrobial only) ctor (Antiraicrob Jj & & O \|ll\| ttii ft;- K. Be vo ------- ------- I PJ •• PI >ir> Tj 181 1 t m t ss ss * I * oo ON 8 2 u Qua ------- GUIDE TO APPENDIX B Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case CytoWnin covered by this Reregistration Eligibility Decision Document. It contains generic data requirements that apply to Cytokinin in all products, including' data requirements for which a "typical formulation" is the test substance. * • ' The data table is organized hi the following format; 1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR Part 158. the reference numbers accompanying each test refer, to the test protocols set in the Pesticide Assessment Guidelines, which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650. 2• Use Pattern (Column 2). This column indicates the use patterns for which the data. requirements apply. The following letter designations are used for the given use patterns: A Terrestrial food ' '. ' B Terrestrial feed C Terrestrial non-food ' , , D Aquatic food E Aquatic non-food outdoor •F • , Aquatic non-food industrial G Aquatic non-food residential , H Greenhouse food ,'.-.". I . Greenhouse non-food • '. • ' • .'-..-.'"'' * • ' Forestry ' , ; -, ' •:'.-. . _',".'•"• ,; K Residential L Indoor food ; , M Indoor non-food ^ N Indoor medical O . Indoor residential 3. Bibliographic citation (Column 3)., If' the Agency has acceptable data in its files, this column lists the identifying number of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study. 199 ------- '.200 ------- '. PQ ti 1 £ .PH. 1 fl 3, 1£ S •'•a 1 W 't* ^jj a> Ui e2 ements i •53 9 "oS T3 .3 .0 ' DO . a •s o a A x> j 0 ,0 3" as.' * a g o» .« "-..'. ' -'• •'"'.'''..'. - : • ' , ' . • • • • ". . ,."'•'. ' . ' • ' • ' ' ~ • r . t- t- t- c- t- t- r- t- t< c- t- t-. VO VO VO . 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' ' > " , ^ ^ ^ ^ ' ^^ ^^ f^'' ^^ vo vo vb vo CM «S «S tS ^H / T- < ^--^ T-H - ' '/ 3 5.. 5 a • • • - . * • ' • • .- '• " ;2 ,' ' i I 1 co >• n< /op gi g .3 .3 ------- § § u -I CM O I g fc £ I 11' CO CO 8. 8 :^f co vo Q • oo O CN OO CN TT CO ' CN 1—4 1—t T—I 88 8 8 s a fS co- -Q 0> eg 1 .63 g d> .i O CD I i Q es rage S 8 CM ------- s cs ------- 204 ------- 4. GUIDE TO APPENDIX C CONTENTS OF BffiLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies in this bibliography have been the body of data submitted tb.EPA and its predecessor agencies in support of past regulatory decisions. Selections from other sources including the published literature, in those instances where they have been considered, are included. : UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials, this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought to identify documents at a level parallel to the published article from within the typically larger . volumes in which they^were submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of review and can be described with a conventional bibliographic citation. The Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single study. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record Identifier, or "MRID number". This number is unique to the citation, and should be used whenever a specific reference is required. It is not related to the six-digit"Accession Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few - cases, entries added to the bibliography late hi the review may be preceded by a nine character temporary identifier. These entries are listed after all MRID entries. This temporary identifying number is also to be used whenever specific reference is needed. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry .consists of a citation containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest known submission. Bibliographic conventions used reflect the standard of Hie American National Standards Institute (ANSI), expanded to provide for certain special needs. a Author, Whenever the author could confidently be identified, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the author. When no author or laboratory could be identified, the Agency has shown the first submitter as the author. b. Document date. The date of the study is taken, directly from the document. When the date is followed by a question mark, the bibliographer has deduced the date from the evidence contained in the document. When the date appears as (19??), the Agency was unable to determine or estimate the date of the document. 205 ------- c. . Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets. d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in addition to any self-explanatory text) the following elements describing the earliest known submission: (1) Submission date. The date of the earliest known submission appears immediately following the word "received." (2) Administrative number. The next element immediately following the word "under" is the registration number, experimental use permit number, petition number, or other administrative number associated with the earliest known submission. (3) Submitter. The third element is.the submitter. When authorship is defaulted to the submitter, this element is omitted. (4) Volume Identification (Accession Numbers). The final element hi the trailing parentheses identifies the EPA accession number of the volume in which the original submission of the study appears. The six-digit accession number follows the symbol "CDL," which stands for "Company Data Library." This accession number is in turn followed by an alphabetic suffix which shows the relative position of the study within the volume^ \ ' 206 ------- BIBLIOGRAPHY MRID CITATION 00074304 Hansen, K.L.; Hewett, T.A.; Beck, L.S. (1981) Primary Dermal Irritation Burst Yield Enhancer and Plant Growth Regulator: Project No. 1658-A. (Unpublished study received May 26, 1981 under 42852-2; prepared by Elars Bioresearch Laboratories, Inc., submitted by Dawn Corp., Denison, Iowa; CDL:245224-A) .00126747 APR Agrichemical, Inc. (19??) OChemical Study: Cytex \|. (Compilation; unpublished study received Mar 28, 1983.under 49554-1; CDL:249893-A) 00138091 Beck, L.; Morita, D.; Hepler, D.; et al. (19980) Rat Acute Oral Tox- • icity: [#8006791081]: Project No. 1055. (unpublished study received Oct 12, 1983 under 4F3020; prepared by Elars Bioresearch Laboratories, Inc., submitted by Atlantic & Pacific Research, Inc., North Palm Beach, FL; CDL:072257-C). ^ 00138092 Rhoads, W.; Morita, D.; Mills, V.; et al. (1979) Cytex Primary Skin Irritation: . Project No. 1055. (Unpublished study receieved Oct, 1983 under 4F3020; prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research , Inc., North Palm Beach, FL. 00138093 Rhoads, W.; Morita, D.; MUls, V.; et al. (1979) Cytex Acute Dermal Toxicity: : -Project No. 1055. (Unpublished study received Oct 12, 1983 under.4F3020; Y , prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research, Inc., North Palm Beach, FL; CDL: 072257-E). . 00138094 Rhoads, Wi; MiUs, V.; Morita, D.; et al. (1979) Cytex Primary Eye Irritation: Project No. 1055. (unpublished study received Oct 12, 1983 under 4F3020; prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research, Inc., North Palm Beach, FL:CDL:072257-F). 94275001 PUmpton, R. (1990) Atlantic & Pacific Research Inc Phase 3 Summary of MRID 00126747. Cytex Physical Chemistry Report: File 76-2203, Prepared :by Atlantic & Pacific Research,Inc. 12 p. 94275005 Plimpton, R.(1990) Atlantici & Pacific Research Inc Phase 3 Summary of MRID 00138092. Cytex Primary Skin Irritation:Project 1055. Prepared by v Rhoads Scientific Company. 8 p. 207 ------- 208 ------- The following is a list of available documents for Cytokinin that my further assist you in responding to this Reregistration Eligibility Decision document. These documents may be obtained;by the following methods: 1 -, •.--,- . ,, - 4 Electronic File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader. Electronic copies can be downloaded from the Pesticide Special Review and Reregistration Information System at 703-308-7224. They also are available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GQV, or using WWW (World Wide Web) on WWW.EPA.GOV., or contact Richard King at (703)-308-8052. 1. PR Notice 86-5. ['. 2. PR Notice 91-2 (pertains to the Label Ingredient Statement). 3. A full copy of this RED document, x ' ' " . ' ' ' • •',''.* , 4. A copy of the fact sheet for Cytokinin. The following documents are part of the Administrative Record for Cytokinin and may included hi the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not available electronically, but may be obtained by contacting the person listed on the Chemical Status Sheet. . . __;".. ; 1. Health and Environmental Effects Science Chapters. - s .',,'• I ,•,'.--• r _ 2, Detailed Label Usage Information System (LUIS) Report. i- . ' The following Agency reference documents are not available electronically, but may be obtained by contacting the-person listed on-the Chemical Status Sheet of this RED document. ,'-'•• • " " N / • i. The Label Review Manual. 2. EPA Acceptance Criteria 209 ------- ------- ------- -------


                  United States
                  Environmental Protection
                  Agency      ~
                        Prevention, Pesticides
                        And Toxic Substances
                        (7501W)
EPA-738-F-95-Q3O
December 1995
                  R.E.D.   FACTS
      Pesticide
Reregistration
                  Cytokinin
      All pesticides sold or distributed in the United States must be
 registered by EPA, based on scientific studies showing that they can be used
 without posing unreasonable risks to people or the environment. Because of
 advances in scientific knowledge, the law requires that pesticides which
 were first registered before November 1, 1984, be reregistered to ensure
 that they meet today's more stringent standards.
 •     In evaluating pesticides for reregistratiori, EPA obtains and reviews a
 complete set of studies from pesticide producers, describing the human ,
 health and environmental effects of each pesticide. The Agency develops
 any mitigation measures or regulatory controls needed to effectively reduce
 each pesticide's risks. EPA then reregisters pesticides that can be used
 without posing unreasonable risks to human health or the environment.
      When a pesticide is eligible for reregistration, EPA explains the basis
 for its decision in a Reregistration Eligibility Decision (RED) document.
 iThis feet sheet summarizes the information hi the RED document for
 reregistration case number 4107, Cytokinm.
   Use Profile
      Cytokinin is a group of plant regulators that promote cell division, leaf
 expansion and retard leaf agmg/Cytokinin is applied to growing crops (field
 crops, vegetable crops, small fruits, vines and tree fruit), young trees,
 ornamentals, and golf courses to increase fruit size, yield, blossoms,
; branching, healthy appearance, and other desirable growth effects.
 Cytokinin is comprised of four naturally occurring cytokinins derived from
 aqueous extract of seaweed meal ~ zeatin [6-(4-hydroxy-3-methylbut-trans-
 2-enylamjno)-purine], N6-methylaminopurine, N^-dunethylaminopurine, and
 N6-isopentenylaminopurine.-- and synthetic cytokinin — kinetin [6-
 (furfurylamino)purine]. Cytokinins (i.e. naturally occurring) in aqueous
 extracts of seaweed meal, are derived from the following algae: Laminaria
 digitaia, Laminaria hyperborea, Fucus serratus and Ascophyllum nodosum.
 Several, if not all of these species of algal species are consumed by man
 and/or livestock. The extracts from these plant species (e.g. the naturally
 occurring Cytokinins) are exempt from the requirements of tolerances when
 used as plant regulators in or on many raw agricultural commodities (40
 CFR 180.1042).

-------
      Formulation Types Registered:
      Formulations include a soluble concentrate/liquid (manufacturing use
 product), and flowable concentrate, soluble concentrate/liquid, ready-to-use
 liquid (end use products).

      Methods and Rates of Application:
      Cytokinin may be applied by aircraft, irrigation system, ground spray
 equipment, seed treatment, or soil incorporation.

      Use Practice Limitations:
      Preharvest Intervals of 14 or 21 .days may be required, depending on
 the crop.

, The Use Practice Limitations listed below do not apply .to all uses on all
 products:
       "Do not allow rinse water to contaminate streams, ponds and lakes, as
       water life may be endangered."
       "Do not apply through any type of irrigation system."
       "Do not apply to any body of water."
       ."For terrestrial uses, do  not apply directly to water or to areas where
       surface water is present or to intertidal areas below the mean high
       watermark."         ."'.'.    >
       "Do not connect an irrigation system (including greenhouse systems)
       used for pesticide application to public water system unless the
       pesticide label-prescribed safety devices  for public water systems are
       in place."
ReaillatorV
     HiStorV
            Plant grow* regulator, Cytokinin, was initially registered in the
  United Sjates ih 1978 M dYTEX* <£PA **• No- 35980-1) for ^Plications
  to certain citrus, fruit and vegetable crops. Cytokinin acts as a plant
  ' regulator by promoting cell division; mimmizuig effects of stress;
  stimulating roots; increasing yield; increasing vegetative growth; and
  increasing tuber firmness.
        During Phase 4 of the accelerated pesticide reregistration process, the
  data base for Cytokinin was evaluated and determined to be inadequate in
  satisfying certain requirements for biochemical pesticides which include
  plant regulators. A DCI was issued in August 1993 to fill the outstanding
  data gaps..

-------
Human Health
  Assessment
      Since the DCI, the Agency's initial position regarding these data gaps
was re-evaluated. All of these data requirements, except a Non-target insects
study, were waived because available information indicates that Cytokinin
does not cause unreasonable adverse effects: (1) The principal constituents
of Cytpkinin (algae and seaweed) are natural components of fish diets, (2)
Cytokinin has a very low acute mammalian toxicity, (3) Cytokinin is used as
a dietary supplement in animal feeds, and (4) Cytokinin pesticide products
are expected to have no adverse effects to fish and wildlife.

Toxicity                                                    .
      In studies using laboratory animals, Cytokinin generally has been
shown .to be of low, acute toxicity.  The acute dermal toxicity
(LD50>2g/kg),. eye irritation (slight irritation), and dermal  irritation
(slightly irritating) place Cytokinin in Toxicity Category HI (the second
lowest of four toxicity categories). Cytokinin's oral toxicity (LD50>5g/kg)
places it in Toxicity Category IV (the lowest of four toxicity categories).

      [NOTE:  For acute oral, dietary, mammalian/avian/aquatic toxicity:
      Category I = very highly or highly toxic             ,
      Category n = moderately toxic
      Category ffl == slightly toxic
      Category IV = practically non-toxic]

Dietary Exposure
      Only the four naturally occurring Cytokinins,derived from, certain
algal species, are exempt from the requirement of a tolerance when used as
a plant growth regulator (40 CFR  180.1042). At this time,  synthetic
Cytokinin is not included inthis tolerance exemption.          >
      Tolerance exemptions are often based on the results of 90-Day (or
longer)  feeding and developmental toxicity studies .submitted to support
reregistration. However; it is the Agency's opinion that these studies can be
waived for naturally occurring and synthetic Cytokinin because of low acute
mammalian toxicity and very low use rates, which would not significantly
increase dietary intake over natural consumption in foods. The Agency, will
be proposing an exemption from the requirement of a tolerance for certain
Cytokinins (zeatin I6-(4-hydroxy-3-methylbut-trans-2-enylamino)-purine],
N6-methylaminopurine, N6-dimethylaminopurine, N6-
isopentenylaminopurine), and synthetic cytokinin — kinetin [6-
(furfurylamino)purine] for all raw agricultural commodities (RACs). The
exemption will apply only when application rates do not exceed 250 grams
of active ingredient/acre/year. The Agency believes this action does not
present any unreasonable risk. It is based on Cytokinin's low acute        ;
mammalian toxicity, its low use rates, exposure in the diet from numerous

-------
                    natural plant food sources, and minimal exposure in the diet derived from
                    consumption of treated commodities under the proposed maximum label use
                    rates.        ,  •
                         The Agency has concluded that dietary exposure risks from consuming
                    commodities treated with Cytokinin, either naturally occurring or synthetic,
                    are not expected.

                    Occupational and Residential Exposure
                         Based on the application methods listed on Cytokinin product, labels,
                    the potential for eye, dermal and inhalation exposure to agricultural workers
                    does exist. However, since Cytokinin is in Toxicity Categories HI and IV
                    for acute oral, dermal, eye irritation and dermal irritation, to reduce worker
                    exposure. The Agency has concluded that these occupational exposures and
                    subsequent risks will be negligible because of Cytokinin's low acute
                    mammalian toxicity and low use rates. Also, the precautionary product
                    labeling stipulated in the RED document will sufficiently mitigate exposures
                    and any subsequent risks to agricultural workers.

                    Human Risk Assessment
                          Since exposures and subsequent risks from Cytokinin applications are not
                    expected, any potential risks from exposure to treated plants will be mitigated by
                    the use of personal protective equipment required by the Worker Protection
                    Standard, supplemented by specific precautionary labeling required by this RED.
                    Post-application reentry workers are required to observe a 12 hour Restricted
                    Entry Interval. Because of Cytokiniri's ubiquitous nature and low toxicity,
                    however, it is a candidate for a reduced reentry interval: from 12 hours to 4
                    fours.             •


Environmental
   Assessment
                          Based on a review of all available ecological data, exposure information,
                    and Cytokinin's non-toxic mode of action, the Agency expects that applications of
                    Cytokinin will pose minimal risk to nontarget wildlife and fish.
                          Environmental fete studies for biochemicals are not imposed unless adverse
                    effects are observed in ecological effects data. Since no adverse effects are
                    anticipated, the Agency will not, at this time, impose any environmental fete data
                    requirements for the currently registered uses of Cytokinin.

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Additional Data EPA is requiring a revised Confidential Statements of Formula (CSFs)
Required an(^ revised product labeling for reregistration.
Product Labeling
Changes
Required
The Agency has reexamined the toxicological data base for Cytokinin
concluded that the current precautionary labeling (i.e. Signal Word,
Statement of Practical Treatment, WPS required labeling, and other label
statements associated with mitigating risks) adequately mitigate any risks
associated with the use of this plant growth regulator.
Regulatory
Conclusion
Based on the reviews of the generic data for Cytokinin, the Agency
has sufficient information on health effects and the potential for causing
adverse effects in fish and wildlife. The Agency has determined that
products containing Cytokinin, when labeled and used as specified in this
RED, will not pose unreasonable risks or adverse effects .to humans or the
environment. Therefore, the Agency concludes that products containing
Cytokinin for certain uses that have a tolerance exemption (i.e. food
uses/commodities listed in 40 CFR 180.1042) are eligible for reregistration.
Other food uses of Cytokinin which do not have an exemption from
tolerance requirements (i.e. -, those food uses/commodities not listed in 40
CFR 180.1042) will become eligible for reregistration only when a
tolerance exemption is issued and becomes a final rule. The Agency plans to
propose such an exemption and pending public comment, issue a final rule
in early 1996. r'-.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Cytokinin during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket,,Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this feet sheet can be downloaded
from the Pesticide SpeciaHteview and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA. GOV, or using ftp on FTP.EPA. GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies ofihe RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information ,
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.

-------
   .  Following the .comment period, the Cytokinin RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
     For mote information about EPA's pesticide reregistration program,
the Cytokrnin RED, or reregistration of individual products containing
Cytokinin, please contact the Biopesticides and Pollution Prevention
Division (7501W), OPP, US EPA, Washington, DC 20460, telephone 703-
308-8712.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN).  Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

- . '• WASHINGTON, D.C. 2Q460
. OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the biopesticide case Cytokinin, which
includes the active ingredients dervied from naturally occurring Cytokinin (zeatin [6-(-4-
hydroxy-3-methylbut-tKms-2^nylaminoO-purine], N6-menthylaminopurine, N6- '
dimethylaminopurine, N^-isopentenylaminopurine) and synthetic Cytokinin (Kinetin -- 6-
;(furfuryl amino) purine). The enclosed Reregistration Eligibility Decision (RED) contains the
Agency's evaluation of the data base of these chemicals, its conclusions of the potential
human health and environmental risks of the current product uses, and its decisions and
conditions under which these uses and products will be eligible for reregistration. The RED
includes the data and labeling requirements for products for reregistration.

To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to-the RED". This summary also; refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. An Application for Reregistration is. required to be
submitted eight months from the date of receipt of this letter. Complete and timely
responses will avoid the Agency taking the enforcement action of suspension against your
products. '•.'•'., ..'•"'.-.' ";...'

If you have questions about our decision or the requirements set forth in this ,
document, please contact the reregistration representative for the Biopesticides and Pollution
Prevent Division, Richard King at (703) 308-8052. ,
Sincerely yours,
Janet Andersen, Acting Director
Biopesticides and Pollution
Prevention Division (7501W)
Enclosures

-------

-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)

.1, DATA GALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DGI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements. If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.

2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect. '

3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of. the date of this letter
.(RED issuance date). •.•'-
- t . ' ' - • -,.•".'.-•
.a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.

b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeUng changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).

c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).

d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits mat are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described hi 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.

-------
      e.  Certification With Respect to Data Compensation Requirements.  Complete and
sign EPA form 8570-31 for each product.                  "      '

4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may.be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED..

5  WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail;

      Document Processing Desk (RED-SRRD-PRB)                         ,
      Office of Pesticide Programs (7504C)
   •   EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001    ,  -,

By express;  .

   Document Processing Desk (RED-SRRD-PRB)
       Office of Pesticide Programs (7504C)
       Room 266A, Crystal Mall 2
       1921 Jefferson Davis Hwy.
       Arlington, VA 22202                 ,

 gt EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
 complete will be returned with a request for corrections. EPA will try to respond to data
 waiver and time extension requests within 60 days.  EPA will also try to respond to all 8-
 month submissions with a final reregistration determination within 14 months after the RED
. has been issued.

-------
REREGISTRATION ELIGIBILITY DECISION

                CYTOKININ

    •\   '  >   .'  "   LISTD     .-•• :  '  ,     ;•  •
    \ ,  • ..     -   * ~  . •    *      '        '

                 CASE4107
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
             BIOPESTICIDES AND POLLUTION
                PREVENTION DIVISION

-------

-------
                       TABLE OF CONTENTS
CYTQKININ REREGISTRATION ELIGIBILITY DECISION TEAM .......... ^  ... i

EXECUTIVE SUMMARY . . .':. . . . u .  ., ...	 ... .... . . . ;\ . . . .';	, v

I.    INTRODUCTION .... ........; . ;. ...... . .'.; .'...'.'.'.' ... ......  ... 1

H.   CASE OVERVIEW . . . . . . . .	.... ,..-.. . ... . .	 .2
     A.    Chemical Overview	 .;. . . .................  . . . 2
     B.    Use Profile	....................  ^ ... 2
     C.    Estimated Usage of Pesticide  . . . .'. ...  . . .... . . , . . . .	5
     D.    Data Requirements ...............•..........*...;....... 6
     E.    Regulatory History .',	 ..7

m.  SCIENCE ASSESSMENT	 . .	 . . . . . . ...', .  . _ 8
     A.    Physical Chemistry Assessment......,..:. .... ... ............ . . 8
     B..    Human Health Assessment...........,..../............... 8
           1. ,   Toxicology Assessment . . ... . .... . . . . ...... ...... .  . •; .8
                a-    Acute Tpxicity   ............ r................ ; 8
           2.    Exposure and Risk Assessment ..................;...,.. 9
             -.:*•',   Dietary Exposure and Risk Assessment ........*.... . 9
                b.    Occupational Exposure^d Risk Assessment . ........ 10
     C.    Environmental Assessment... .','. . ...  .... , . . . ..'.. ... , ..... . ... . IQ
           1,,   EcologicalToxicity Data  . ., . .  . ; . . . ... , ; . . . ; ... . ,', .  . . 10
           2.    Environmental Fate  ...... i ....................... n

IV.  RISK MANAGEMENT AND REREGISTRATION DECISION . :, . ....... 11
     A.    Determination of Eligibility  . . . . . . . ...."	 . . .....;  11
           1.    Eligibility Decision .......................! 1 !;! !v! 12
           2.    Eligible Uses  .... ..v. ....................... ..;. 12
     B.    Regulatory Position  . . .... . . . . ................'........ 14
           1.    Tolerance Reassessment	  . ;..........	 14
           2.    Endangered Species Statement .  .....,'. .... ...  ;.......... 14
           3.    Labeling Rationale .  ..... . . :..... . . . ...  . . . . , . ...  . . 15
i  • •  •           ...      '       _"..'•  .       • .          •
V.   ACTIONS REQUIRED BY REGISTRANTS ....,...............!  16
     A.    Manufacturing-Use Products  .....	.................... 16
           1.    Additional Generic Data Requirements	 . ... . .','. ..... 16
           2.    LabeUng Requirements for Manufacturing-Use Products ...... 16
     B.    End-Use Products  .... . .  . . . . ... .... , ........ .... ...... 17
           1.    Additional Product-SpecificData Requirements ............ 17

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           2.    Labeling Requirements for End-Use Products	17
      C.    Existing Stocks	18

VI.   APPENDICES 	:..............:...	  19
      APPENDIX  A.   Table of Use Patterns Subject to Reregistration  .......  20
      APPENDIX  B.   Table of the Generic Data Requirements and Studies Used to
           Make the Reregistration Decisiop	  199
      APPENDIX  C.   Citations Considered to be Part of the Data Base Supporting the
           Reregistration of Cytokmin	 . . .  205
      APPENDIX  D. ,   List of Available Related Documents	208

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CYTOKININ REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:
Biological and Economic Analysis Division
         i           .      •   -  '
George Keitt
EricMauer
Thomas Harris
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
 Labeling Use Information
Biopesticide and Pollution Prevention Division

Clay Beegle
Denise Greenway
Christina Hartman (USDA-IR-4 Group)
Phillip Button              .
Richard King
J. Thomas McClintock
Sheryl K. ReiUy
Robert I. Rose
William Schneider
Roy Sjoblad
JohnTice        ;   . >
Freshteh toghrol           ;
Robert Torla

-------

-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
CAS
CI
CNS .
CSF
DFR
ORES
DWEL
EEC

EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA

HOT
LD«
lo
LD,
LEL"
LOG
LOD
LOEL
MATC
MCLG

ug/g
mg/L
MOE
MP
MPI
MRIp
N/A '-.-
NOEC
NPDES
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent ...
Active Ingredient .
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula •
Dislodgeable Foliar Residue . . - '
Dietary Risk' Evaluation System.
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
. water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
-occur.
Estimated Environmental Concentration, The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product '
U.S. Environmental Protection Agency
Food and Drug Administration •
Federal Insecticide, Fungicide, and Rcfdenticide Act ,
Federal Food, Drug, and Cosmetic Act
Functional Observation Battery ' • .
Gas Liquid Chromatography ' . . . .
Geometric Mean ' . :
Generally Recognized as Safe as Designated by FDA :
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested
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/l,mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
s 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., nig/kg.
. Lethal Dose-low. Lowest Dose at which lethality occurs. . ,
Lowest Effect Level • "'-' , .
Level of Concern
Limit of Detection
Xowest Observed Effect Level ,
Maximum Acceptable Toxicant Concentration , ,
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water urider the Safe Drinking Water Act. \
- Micrograms Per Gram ..
Milligrams Per Liter • '
Margin of Exposure . , •
• Manufacturing-Use Product ' , ' • '
Maximum Permissible Intake ! , '
Master Record Identification (number); EPA's system of recording and tracking studies submitted.
Not Applicable
No effect concentration , / - . .
National Pollutant Discharge Elimination System . '
111

-------
GLOSSARY OF TERMS['AND ABBREVIATIONS

NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level '.
OP Organophosphate
OPP Office of Pesticide Programs " ...
PAD! ' Provisional Acceptable Daily Intake •. . ' .
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method -
PHED Pesticide Handler's Exposure Data • , '
PHI ' Preharvest Interval .. . .
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million. • .
PRN Pesticide Registration Notice
Q*, , The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell .
RED . • Reregistration Eligibility Decision •
REI Restricted Entry Interval , .
RfD Reference Dose, •
RS Registration Standard . '
SLN Special Local Need (Registrations Under Section 24 © of FIFRA) ,
TC • Toxic Concentration. The concentration at which a substance produces a toxic effect:
TD Toxic Dose. The dose at which a substance produces a toxic effect. .
TEP Typical End-Use Product ' ( „- ,
TGAl Technical Grade Active Ingredient _
TLC Thin Layer Chromatography - .
TMRC Theoretical Maximum Residue Contribution -
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
,WP Wettable Powder
WPS Worker Protection Standard
IV

-------
EXECUTIVE SUMMARY

       The Environmental Protection Agency has completed an assessment of the potential human
health and environmental risks associated with the pesticidal use of Cytokinin in the United States.

       Cytokinin is a group of plant regulators that promote cell division,  leaf expansion and
retard leaf aging. Cytokinin is comprised of four naturally occurring cytokmins (derived from
aqueous extract of seaweed meal) - zeatin [6-(4-hydroxy-3-methylbut-trahs-2-enylammo)-purine],
N6-methylammopurine,  l
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-------
I.     INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process.. The first four phases of the-process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.

     1 FIFRA Section  4(g)(2)(A)  states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredients are eligible for reregistration" before calling
in data on products, and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base 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 the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.

       This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses  of  Cytokinin.  The document consists of six sections. Section I  is the
introduction. Section H describes Cytokinin, its uses, data requirements and regulatory history.
Section m discusses .the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for Cytokinin. Section  V discusses
the reregistration requirements for Cytokinin. Finally, Section VI is the Appendices which support
this Reregistration Eligibility Decision. Additional details concerning the Agency's review of
applicable data are available on request.
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H.    CASE OVERVIEW

       A.    Chemical Overview             .  ,

             The following active ingredients) are covered by this Reregistration Eligibility
       Decision:
             Common Name:
             Chemical Name:
                   Cytokinin (four naturally occurring Cytokinins derived from
                   aqueous extract of seaweed meal) and Kinetin (synthetic
                   Cytokinin).                                        ,

                   Cytokinin — zeatin  [6-(4-hydroxy-3-methylbut-trans-2-
                   enylamino)-purine],  N6-methylaminopurine,
                                N6-dimethylaminopurine, N6-
                          isopentenylaminopurine.
                   Kmetm - 6-(furfuryl aminp) purine

Chemical Family:   Purine

CAS Registry Number:     525-79-1

OPP Chemical Code:      116801                          '

Trade and Other Names:   CYTEX",  Nitrozyme ,  CYTOGEN ,  and  Burst
                          Yield Booster".
              Basic Manufacturers:
        B.    Use Profile
                          Riverside/Terra Corp.
                          Atlantic & Pacific Research
                          Atlantic-Lab., Inc
                          Aqua-10 Corp.
                         * Westbridge Agricultural Products
                          Stqller Enterprizes Inc. .
                          P?B.T., fee.
                          Transagra International Inc.
                          P.B. Ohrstrom & Sons Inc.
                          Arcadian Seaplants Ltd.
              The following is information on the currently registered uses with an overview of
        use sites and application methods.  A detailed table of these use of Cytokinin is in
        Appendix A.

        For Cytokinin:
-------
  Type of Pesticide:  Plant Regulator

 •Use-Sites: / '   .    ..•  '    .,      ,       •..'••  V  ,       •   .".'•''.'-•   '..

  TERRESTRIAL FOOD CROP: anise, asparagus, banana, , broccoli, brussels sprouts,1
  cabbage, carrot (including tops),  catjang (Jerusalem/marble pea), cauliflower, celery,
  cucumber,  eggplant, fennel, garbanzos (including chick peas),  garlic, leek,  lettuce!
  melons, cantaloupe, honeydew, muskmelons, watermelons, okra, onion, parsley, peach,'
  pepper, pepper (chili type),  plantain, pumpkin, radish, shallot, spinach, squash (all or
  unspecified), strawberry, sweet potato, wheat, yam

  TERRESTRIAL FOOD+FEED CROP: apple; beans; beans, dried-type; beans, mung;
  beans, succulent (lima); beans, succulent (snap); beets (unspecified); citrus fruits; corn
  (unspecified); corn, field; corn, pop; corn, sweet; cotton (unspecified); cowpea/blackeyed
  pea; grapes; leafy vegetables; orange; peanuts .(unspecified); peas (unspecified); peas,
  field;  peas, pigeon; peas,  southern; potato, white/irish; rice;  sorghum; sorghum
  (unspecified); soybeans (unspecified); sugar beet; tomato; triticale; wheat

 TERRESTRIAL FEED CROP: alfalfa, capes, lupine

 TERRJSTRIAL+GREENHOUSE FOOD CROP: asparagus; banana; beans; broccoli;
 broccoli, Chinese; Brussels sprouts; cabbage; carrot (including tops); cauliflower;  celery;
 corn,pop; corn,sweet; cucumber; cucurbitvegetables; eggplant; lettuce; melons; nectarine-
 onion; parsley; parsley.turnip-rooted; peacji; pepper; pepper (chili type); plantain; potato,
 white/irish; pumpkin;  radish; shallot; spinach;  squash (all or unspecified); squash (winter);
 squash (zucchini); strawberry; sweet potato; tomato

 TERRESTRIAL GREENHOUSE FOOD CROP: potato, white/irish, tomato

. TERRESTRIAL NON-FOOD CROPrcommerdal/industrial lawns, fruits (unspecified),
 golf course turf, jujube, ornamental lawns and turf, ornamental sod farm (turf), recreation
 area lawns, small fruits  .    x

 TERRESTRIAL NON-FOOD+OUTDOO                            and/or shade
 trees, ornamental herbaceous plants, ornamental lawns and turf, ornamental nonflowering
 plants, ornamental woody shrubs and vines, site term too general

 TERRESTRIAL  GREENHOUSE NON-FOOD:  ornamental and/or shade  trees,
 ornamental herbaceous plants, ornamental woody shrubs and vines

FORESTRY: forest plantings (reforestation programs), pine (forest/shelterbelt)

OUTDOOR RESIDENTIAL: ornamental lawns and turf
-------
INDOOR RESIDENTIAL: ornamental trees, ornamental herbaceous plants, ornamental
nonflowering plants

Target:      Higher Plants

Formulation Types Registered:

       MANUFACTURING PRODUCTS:
       -Form not identified/liquid   0.01   to     0.01%
             Soluble concentrate/liquid   0.0040 to    0.0120%

       END USE PRODUCTS:
       ~    Flowable concentrate       0.004  to    0.0096.%
             Liquid-ready to use        0.00008 to   0.00008%
              Soluble concentrate/liquid   0.0003 to    0.0400%

 Method and Rates of Application:

 Equipment: Aircraft. Center pivot irrigation, Dip tank, Drip irrigation, Ground, Hand
 move irrigation, High volume ground sprayer, Hose-end sprayer, Irrigation, Low volume
 ground sprayer, Mist sprayer, Moving wheel irrigation, Not on label, Pressure sprayer,
 Seed treater, Soil incorporation equipment,  Solid set  irrigation, Sprayer, Sprinkler
• irrigation,

 Types of  Treatment:  Band  treatment, Bark treatment,  Broadcast, Chemigation,
 Commercially  grown nursery grass  sod treatment,  Dip  treatment.  Drench, Foliar
 treatment, High volume spray (dilute), Low, volume spray (concentrate), Seed treatment,
 Soil band treatment, Soil broadcast treatment,  Soil drench treatment, Soil in-rarrow
 treatment,  Soil incorporated tteatment,  Soil sidedress treatment, Spot soil treatment,
 Spray.             '  •    ;

 Timing: At'-first squaring (of cotton), At pegging (of peanut), At permanent flood (of
 .rice), At pinhead square (of cotton),  At planting, Bloom, Boot,  Bulbs, Containerized,
  Crown, Cutting, Delayed dormant, Early bloom, Early tillering,  Established plantings,
 Fall, Foliar,  Fruiting, Petal fall, Pink,  Plant bed,  Post-thinning,. Postemergence,
  Posmarvest, Postplant, Posttransplant, Prebloom, Precutting,  Preharvest,  Preplant,
  Pretransplant, Root stock, Seed piece,  Spring,  Tassel, Transplant, Tuber, When needed.

  Use Practice Limitations:

        Preharvest Intervals - 14 or 21 days depending on crop.

  Use Practice Limitations listed below do not apply to all uses on  all products:
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       Do not allow rinse water to contaminate streams, ponds and lakes, as water life
       may be endangered.

       Do not apply through any type of irrigation system.

       Do not apply to any body of water.               .    '

       For terrestrial uses, do not apply directly to water or to areas where surface water
       is present or to intertidal areas below the mean high water mark.-

       Do not connect an  irrigation system (including greenhouse systems) used for
       pesticide application.to public water system unless the pesticide label-prescribed
       safety devices for public water systems are in place.
               .     'V       '        ;          '                 . .               '
C.     Estimated Usage of Pesticide
                            . •('      •                        '          -        /
       This section summarizes the best estimates available for the pesticide uses of
Cytokinin.  These estimates:are derived from a variety  of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop)l>asis,
reflect annual fluctuations in use patterns as well as the variability in using data from
various information sources.

       The table below.summarizes Cytokinin use by site.
                                   •5 '• '•
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TABLE I: Percent of Various Crops Treated Annually with Cytokinin, 1990 -1992
•Bm«BnasHaBEEEaK
Site/1
^K-eg^Qgg9gg^ggg^ggj^^S3^^5E^3


Cotton '
Eggplant/Peppers
Melons

Potatoes
Rice



TOTALS
Acres Grown/2
(OOP) .
480.2
662.9
76.482.3
* 13.230.2
72.6
408.9
622.3
1.377.9
2.983.0
58,768.3 :
474.7
17.007.0

Acres Treated
(OOP)
50-75
5-50
1-5
5-55
0-1 '
1-5
1-5
1-10'
0-1'
0 - 1
1-2
0-1 • - '
66-211
Percent Crop
Treated
. 10-16
1 -8
<1-<1
0-<1
0-1
<1 - 1
0-1
0-1
0 - <1
0 - <1
0-<1
0-<1

Pounds Al
Applied/3
2-5
7-66
0-<1
7-<1
0-1
0-7
1 -7
1-<1.
0 - <1
0-<1
1-<1
0-<1
19-93
 /I -Site identification basedxm REFS.       •   •'•-•''
 12 - Acres grown based on USDA, Agricultural Census, and state statistics.          -
 13- Pounds AI based on .012% active ingredient in Foliar Triggrr,

 Data based on proprietary sources, USDA, and state statistics.                  -                    •

 Note- All other sites had either no known usage oiavailable data. Those with no known usage data include grapes, strawberries, onions, peaches,
 Brussels sprouts, cauliflower, lettuce, paisley, cucumbers, celeiy, potatoes, broccoli, cabbage spinach, carrots and asparagus.

 Those with no available data include bananas, squash, radish, okra, beets, peanuts, turf, and ornamental.     .
         D.     Data Requirements

                 In Phase 4 of the Reregistration Process data gaps for Cytokinin were identified
         and a DCI was issued in August 1993 for studies on ecological effects, environmental fate, •
         and mammalian  toxicity. These  data were required to support the uses  of products
         containing the active ingredients  Cytokinin and Kinetin (i.  e. naturally occurring and
         synthetic Cytokinin). Appendix B includes all data requirements identified by the Agency
         for currently registered.uses needed to support reregistration.   •   ,
-------
E.     Regulatory History

      The plant regulator, Cytokinin, was initially registered in the United States in 1978
as CYTEX* (EPA Reg. No. 35980-1) for applications to certain citrus, fruit and vegetable
crops. Cytokinin acts as a plant regulator by promoting cell division; minimizing effects
of stress; root stimulation; increased yield; increased vegetative growth; and increased
tuber firmness.

       During Phase  4 of the Reregistration Process, the data base for Cytokinin was
evaluated and  determined to be inadequate  in satisfying certain requirements for
biochemical pesticides which include plant regulators. The following were identified as
outstanding data gaps  and a DCI was issued in August 1993:

                     152B-12      Acute inhalation
              .       152B-15      Dermal sensitization
                     152B-17      Genotoxicity
                     154B-6       Avian acute pral/toxicity
                     i54B-7a      Avian dietary quail
                   '  154B-8a      Fish toxicity-rainbow trout
                     154B-9       Invertebrate toxicity
         ^            154B-11      Non-target insects

       Since the DCI, the Agency's initial position about these data gaps was re-evaluated
and all of these data requirements, except for 154 B-ll Non-target insects, were waived
because available information indicates Cytokinin does not cause unreasonable adverse
effects: (1) The principal constituents of Cytokinin, algae and seaweed,  are natural
components of fish diets, (2) Cytokinin has a very  low acute mammalian toxicity, (3)
Cytokinin is used as a dietary supplement in animal feeds, and (4) are expected to have no
adverse effects to fish and wildlife.                                          '_..;•"

       During development of the reregistration eligibility decision (RED), the data
requirements for non-target insect testing were re-examined and these data requirements
were waived based on the previously mentioned rationale for ecological effects (i.e., low
acute mammalian toxicity; use as a fish and animal food supplement; and lack of expected
adverse  effects  to fish and wildlife). Therefore, the data are adequate to  support the,
currently .registered uses of Cytokinin.

       This Reregistration Eligibility Decision reflects a reassessment of all data which
were submitted in response to the Reregistration Process.
-------
HI.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

       Below are the basic physical chemistry characteristics of Cytokinin, both naturally
occurring and synthetic.
       B.
             Characteristics

             Color

             Physical State

             Odor


             Density
                                       Results

                                       Light brown

                                       Liquid

                                       No characteristic odor;
                                       "pleasant, spicy".

                            .           1.02g/ml@20°C  .

                                   .  •' 4,0-.     .   •'   .':   ..  '.

Viscosity                               27 Zahn units @ 25°C

Corrosive characteristic                  Non-corrosive

Human Health Assessment

1.     Toxicology/Assessment
                                   1 •   -        •  \          *~>
       Adequate mammalian toxicology data on Cytokhiin is available and will
support a Reregistration Eligibility Decision (RED).

       a,   , Acute Toxicity

             Certain acute toxicity studies conducted with Cytokinin have been
       submitted and adequately satisfy the requirements as set forth hi 40 CFR
       158.690 — Biochemical pesticides.
                                           8
-------
                        TABLE II: ACUTE TOXICITY OF CYTOKININ
Guideline
No.
152B-10
152B-11
152B-12
152B-13*
152B-14*
152B-15*
152B-16*
Study
Acute oral tox. (rat)
Acute dermal tox.
(rabbit)
• Acute inhalation
Eye irritation (rabbit)
Dermal irritation
(rabbit)
Dermal sensitization
Hypersensitivity
Results •
LD 50> 5g/kg. Dose
tested 5g/kg.
LD 50> 2 g/kg
Waived
Slight irritation
Slightly irritating
Waived
All incidents must be
reported to the Agency.
Category '
4
3
.
3
3

.
MRID
00142864
00138093

00138094
00074304 ,
N/A
N/A
These data are not required to support the reregistration of the TGIA.
                          Based on  the data submitted  summarized above  (fable II),
                   Cytokinin has a very low acute mammalian toxicity. Cytokinin is naturally
                   occurring in numerous plant food sources and is a food supplement. Even
                   with this dietary availability, no adverse effects have been reported to the
                   Agency. The following[guideline requirements have been waived: 152B-12
                   — Acute inhalation;  1528^15  Dermal sensitization.   All incidents of
                   hypersensitivity must be reported to the Agency,  At this time, it is the
                   Agency's opinion that the toxicology data are adequate for reregistration
                   of Cytokinin.  .                                            "
                   .Exposure and Risk Assessment

                   a.     Dietary Exposure and Risk Assessment

                          Only the four naturally occurring Cytokinins, derived:from certain
                   algal species, are exempt from the requirement, of a tolerance when used
                   as a plant growth regulator (40 CFR 180.1042). At this time, synthetic
                   Cytokinin is not included in this tolerance exemption.

                          Tolerance exemptions are often based on the results of 90-Day (or
                   longer) feeding and developmental toxicity studies submitted to support
                   reregistration. However, it is the Agency's opinion that these studies can
                   be waived for naturally occurring and synthetic Cytokinin because of low
                   acute mammalian toxicity and  very low use rates  which would not
-------
             significantly increase dietary intake over natural consumption in foods, in
             The Agency, will be proposing an exemption from the requirements of a
             tolerance for certain Cytokinins (zeatin [6-(4-hydroxy-3-methylbut-trans-2-
             enylamino)-purine], h^-methylaminopurine, N6-dimethylaiminopurine, N6-
             isopentenylaminopurine),  and   synthetic   cytokmin  —  kinetin  [6-
             (furfurylamino)purine] for all raw agricultural commodities (RACs). The
             exemption will apply only when application rates do not exceed 250 grams
             of a.i./acre/year. The Agency believes  this action does  not  present
             unreasonable risk. It is based  on low acute mammalian toxicity, low use
             rates, exposure in the diet from numerous natural plant food sources, and
             minimal  exposure-in the  diet derived from consumption of treated
             commodities under the proposed maximum label use rates.

                   The Agency has  concluded that the risks ;from dietary exposure
             derived from consuming commodities  that were treated with Cytokinin,
             either naturally occurring or synthetic, are not expected.
             b.     Occupational Exposure and Risk Assessment

                    Based on the application methods listed on the product labels, the-
             potential for eye, dermal arid inhalation exposure to agricultural workers
             does exist. However,  since Cytokinin is in Toxicity Categories m and IV
             for acute oral, dermal, eye irritation and dermal irritation, these toxicity
             categories, do not trigger any  additional requirements for evaluation of
             reduction in worker exposure. The Agency has concluded that these
            . occupational exposures and subsequent risks will be negligible because of
             Cytokinin's low acute mammalian toxicity and low  use rates. Also, the
             proposed precautionary product labeling  stipulated in Section V will
             sufficiently mitigate exposures and subsequent risks to agricultural workers.

C.     Environmental Assessment

       Cytokinin is well  characterized  as a plant growth  regulator and has  been in
continuous use since 1978 without any reports to the Agency of adverse effects to humans
and the environment. Cytokinin is widely known to stimulate cell  division and several
other specific metabolic processes .in certain test systems. However, it's exact biochemical
mode of action is not yet understood.

       1.     Ecological Toxicity Data

             Cytokinin is a foliar and broadcast-applied plant growth regulator. A DCI
       for the following set of ecological toxicity data was issued on August 3, 1993:
       Avian Oral Toxicity (154B-60, Avian Dietary Exposure (quail) (154B-7a), Fish
                                    10
-------
              Toxicity (154B-8a), Invertebrate Toxicity (154-B-9), and Nontarget Insect Testing
              (154B-11). The Agency granted waivers for the Avian Oral Toxicity (154Br6),
              Avian Dietary Exposure  (154B-7a),  Fish  Toxicity 154B-8), and Invertebrate
              Toxicity 154B-9) on April 29, 1994. The Agency granted waivers for these studies
              based in part on a review of supplemental  ecological toxicity data submitted in
              1985 and low exposure rates (approximately  146 mg a.i./A). These data indicated
              mat Cytokinins were "practically non-toxic" on an acute basis to birds, freshwater
              fish,  and freshwater  invertebrates. Additional data waivers were granted for
              Nbntarget Insect Testing (154B-11) and Nontarget Plant Testing (154B-10) Were
              grant in July of 1995  as part of the RED development process utilizing the
              previously mentioned rationale relating to low exposure. Based on a review of all
              available ecological toxicity data and exposure information, the Agency expects
              that Cytokinins will pose a minimal risk to non-target wildlife and fish.   •
             2.
Environmental Fate
                    Environmental fete studies are Tier n studies for biochernicals and are not
             imposed unless adverse effects are observed in Tier I Environmental Data. Since
             no adverse ecological effects are anticipated, the Agency will not impose^ at this
             time, any environmental fate  requirements for the currently registered uses of
             Cytokinin.          ,
IV.    MSK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility                                      ,  ,

             Section 4(g)(2)(A) of FJFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredients are  eligible for reregistration. .The Agency has previously identified and
       required the submission of the genericTci.e. active ingredient specific) data required to
       support reregistration of products containing Cytokinin as the sole active ingredient,  The
       Agency has completed its review of these generic data and has determined that the data are
       sufficient  to^ support reregistration ,of  some, uses  containing Cytokiriin.   Eighteen
    ;   previously mentioned uses of Cytokinin do not have  an exemption from tolerance. The
       Agency plans to propose an  exemption from tolerance for many plant regulators, including
       Cytokinin,  when used in low doses. Pending public comment, the Agency plans  to publish
       a final rule in 1996. When this proposed exemption from tolerance is final, these eighteen
       uses of Cytokinin will be eligible for reregistration. Appendix B identifies the generic data
       requirements that ,the Agency reviewed as part of its determination  of reregistration
       eligibility of Cytokinin, and lists the submitted studies that the Agency found acceptable.

             The data identified in Appendix B were sufficient to allow the Agency to assess the
       registered  uses of Cytokinin which have tolerance exemption and to determine that the
                                          11
-------
currently registered uses would not result in unreasonable adverse effects to humans and
the environment.             .                                           '.-.,.

       The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting  acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B.  Although the Agency has found that the currently registered uses of
Cytokhiin are eligible for reregistration, it should be understood that the Agency may take
appropriate regulatory action, and/or require the submission of additional data to support
the registration of products containing Cytokmin,  if new information comes to the
Agency's attention or if the data requirements for  registration (or the guidelines for
generating such data) change.
       1.
Eligibility Decision
              Based on the reviews of the generic data for the  active ingredients
       Cytokinin, the Agency has sufficient information on the health effects of Cytokinin
       and on its potential for causing adverse effects in fish and wildlife and the
       environment.  The Agency has determined that Cytokinin products, labeled and
       used as. specified in this Reregistration Eligibility Decision, will not pose
       unreasonable risks or adverse effects to humans or the environment.  Therefore,
       the Agency concludes that products containing Cytokinin for registered uses listed
       below are eligible for product reregistration.

       2.     Eligible Uses
              t                       *.      .-,.''      '                -
              The Agency has determined that the uses of Cytpkinin listed below are
       eligible for reregistration. .

       TERRESTRIAL FOOD CROP: asparagus, banana, broccoli, brussels sprouts,
       cabbage, carrot (including tops), cauliflower, celery, cucumber, eggplant, lettuce,
       melons, cantaloupe, honeydew, muskmelons, watermelons, okra, onion, parsley,
       . peach, pepper, pepper (chili type), radish, spinach, squash (all or unspecified),
       strawberry, sweet potato,  wheat             -

       TERRESTRIAL FOOD+FEED CROP: apple; beans; beans, dried-type; beans,
       mung; beans, succulent (lima); beans, succulent (snap);  beets (unspecified); corn
       (unspecified);  corn, field;  com, pop; corn,  sweet; cotton (unspecified);
       cowpea/blackeyed pea; grapes; orange; peanuts (unspecified); peas (unspecified);
       peas, field; peas, pigeon; peas, southern; potato, white/Irish; rice;  sorghum;
        sorghum (unspecified); soybeans (unspecified); sugar beet; tomato;  wheat

       TERRESTRIAL FEED CROP: alfalfa, cowpeas
                                     12
-------
      TERRESTRIAL+GREENHOUSE FOOD CROP: asparagus; banana; beans;
      broccoli; Brussels sprouts; cabbage; carrot (including tops); cauliflower; celery;
      corn, pop; corn, sweet; cucumberjeggplant; lettuce; melons; nectarine; onion;
      parsley; peach; pepper; pepper (chili type); potato, white/Irish; pumpkin; radish;
      shallot; spinach; squash (all or unspecified); squash (winter); squash (zucchini);
      strawberry; sweet potato; .tomato

      TERRESTRIAL GREENHOUSE FOOD CROP: potato, white/Irish, tomato

      TERRESTRIAL NON-FOOD CROP: commercial/industrial lawns,  fruits
      (unspecified), golf course turf, jojoba, ornamental lawns and turf, ornamental sod
      farm (turf), recreation area lawns, small fruits

      TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL: ornamental and/or
      shade trees, ornamental herbaceous plants, ornamental lawns and turf, ornamental
      nonflowering plants, ornamental woody shrubs and vines

      TERRESTRIAL  GREENHOUSE  NON-FOOD:  ornamental shade  trees,
      ornamental herbaceous plants, ornamental woody, shrubs and vines

      FORESTRY: forest plantings (reforestation programs), pine (forest/shelterbelt)
      OUTDOOR RESIDENTIAL:ornamental lawns and turf

      INDOOR RESIDENTIAL: ornamental and/or shade trees, ornamental herbaceous
      plants, ornamental nopflowering plants

      The following 18 uses of Cytokinin do not have a tolerance or tolerance exemption
from the requirements of a tolerance. The Agency plans to propose such an exemption in
from tolerance for Cytokinin in 1996 and, pending public comment, issue a final rule.
      Anise
      Catjang
      Chinese broccoli
      Citrus, fruits
 Garbanzos beans
 Garlic
 Leafy vegetables
'Leeks  ,
      Cucurbit vegetables  Lupines
      Fennel             Nectarines
Plantains
Pumpkins
Shallots
Triticale
Turnips
Yams
B.    Regulatory Position
                                 13
-------
 '  "  -The following is a summary  of the regulatory positions and rationales  for
Cytokinin. Where labeling revisions are imposed, specific language is set forth in Section
V of this document.
       1.
Tolerance Reassessment
              Cytokinins (i.e. naturally occurring) hi aqueous extracts of seaweed meal,
       are derived from the following algae: Lamnaria digitata, Laminaria hyperborea,
       Fucus serratus and Ascophyllwn nodosum. Several, if not all of-these species of
       algal species are consumed by man and/or livestock. The extracts from these plant
       species  are exempt from the  requirements of tolerances when used as plant
       regulators in or on many raw agricultural commodities (40 CFR 180.1042). Under
       the provisions of this tolerance exemption (40 CFR 180.1042), synthetic Cytokinin
       - Mnetin is not exempted from the requirements of a tolerance.

             The  Agency  plans to  propose to exempt from the  requirement of a
       tolerance, ten plant regulators, including Cytokinin (i.e. both naturally occurring
       and  synthetic), for all RACs. This  exemption is based  on the plant growth
       regulator's low use rates, natural exposure in the diet from numerous plant food
       sources, minimal  anticipated increase in dietary exposure over the naturally
      . occurring exposure in the diet when using the maximum label .rates, and low
       mammalian toxicity.

              Naturally occurring  Cytokinin (zeatin,  N6-methylaminopurine,  ft•-_
       dimethylaminopurine, and r^-isopentenylaminopurine), and synthetic Cytokinin -
       kinetin will be exempt from the requirements of a tolerance when applied to
       growing crops (all RACs) at application rates not exceeding 250 grams/acre/year
       once the proposed tolerance exemption for plant growth regulators becomes a final
       rule.                      •                                     !

       2.     Endangered Species Statement

              Based on the current use patterns,  the  potential for adverse effects to
        endangered  plant and animal species from  applications of Cytokinin  is  not
        expected.                                                               .

       .3.    Labeling Rationale                           .

              Precautionary Labeling:

                     The Agency has reexamined the toxicological  data base for
               Cytokinhi arid concluded mat the current precautionary labeling (i.e. Signal
              Word, Statement. of Practical Treatment,  and other label statements
                                     14
-------
associated with mitigating risks) adequately mitigate the risks associated
with the use of this plant regulator.

Workers Prptection Requirements:

       The 1992 Worker Protection Standards for Agricultural Pesticides
(WPS) established  certain workers-protection requirements  (personal
protective equipment, restricted entry intervals, etc.) to be specified on the
label of all products that contain uses within the scope of WPS. Uses within
the scope of the WPS  include all commercial (non-homeowner) and
research uses on farms, forests, nurseries, and greenhouses to produce
agricultural plants (including  food, feed,  and fiber plants, trees, turf
grasses, flowers, shrubs, ornamental, and seedlings). Uses within the scope
include not only uses on plants, but also uses on soil or planting medium
the plants are (or will be) grown in. At this time all currently registered
uses of.Cytokinin, except for golf course uses (greens, fairways, and tees),
are within the scope of the Worker Protection Standards for Agricultural
Pesticides.

       Any  product  whose labeling  reasonably  permits  use  in the
production of an agricultural plant on  any farm,  forest,  nursery, or
greenhouse must comply with the labeling requirements of PR Notice 93-7,
'^Labeling Revisions Required by the Worker Protection Standards WPS)",
and PR Notice 93-7 and 93-11 are to be on the product label exactly as
instructed in those notices,   ,

       On April 25, 1995, the Agency  established a policy which allows
registrants to reduce the interim WPS restricted entry interval (REI) from
12 hours to 4 hours for certain low  risk pesticides.  This policy identifies
Cytokinin as a candidate eligible for a reduced WPS REI. The procedures
for requesting a reduction in the REJ are outlined in Section V.

Personal Protective Equipment (PPE);
                                       -  7.'-         -           '

       All PPE labeling requirements for products containing Cytokinin
were established using the process described hi PR Notice 93-7 or more
recent EPA guidelines. This RED will not impose any changes to the PPE
WPS labeling requirements established in PR Notices 93-7 and 93-11..

Restricted-Entry Intervals REI):                       ,

       Under the WPS, interim REI for  all uses within the scope of the
WPS were established on the basis of the acute mammalian toxicity of the
active ingredient. The toxicity categories of the active ingredient for acute
                       15
-------
                   dermal toxicity, 'eye irritation potential, and skin irritation potential were
                   used to determine the interim WPS REI. If one or more of the three8
                   toxicity categories is classified as toxicity category I, the interim WPS REI
                   is established at 48  hours. If none of the  acute toxicity effects  are in
                   , category I, but one or more of the three is classified as category HI, the
                   interim WPS REI is established at 24 hours. If none of the three acute
                   toxicity effects are in category I or n, the interim WPS REI is established
                   at 12 hours. The interim WPS REI for Cytokinin is 12 hours, since all of
                   the acute toxicity categories are either HI or IV.

V.     ACTIONS REQUIRED BY REGISTRANTS

       This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
       A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic, data base supporting the reregistration of Cytokinin for the
             above eligible uses has been reviewed and determined to be substantially complete.
             At this time, no additional data are being required. However,  the Agency is
             requiring that a revised Confidential Statement of Formula (CSF) and revised
             product labeling be submitted within eight months of the issuance of this document.

             2.     Labeling Requirements for Manufacturing-Use Products

                    At this time, no additional  labeling requirements are being imposed on
             manufacturing use products containing Cytokinin as an active ingredient.

       B.    End-Use Products                                           .

             1.     Additional Product-Specific Data Requirements       '      '

                    Section 4(g)(2)(B) of EEFRA calls for the Agency to obtain any needed
             product-specific data regarding the pesticide after a determination of eligibility has
             been made.  However, th'e data base supporting  the reregistration of the above
             eligible end-uses of Cytokinin is substantially complete and no additional product
              specific data is being required at this time. However, the Agency is requiring that
            .  a revised Confidential Statement of Formula (CSF) and revised product labeling
             be submitted within eight months of the issuance of this document.

             "2.     Labeling Requirements for End-Use  Products


                                           16
-------
Worker Protection Standard Labeling:

       The interim WPS REI for Cytokinin is 12 hours and is based on acute
mammalian toxicity. The Agency has determined that the interim REI of 12 hours
may, in certain circumstances, be reduced to 4 hours for pesticides with low acute
mammalian toxicity. Cytokinin is a candidate for a reduced REI.

       If registrants of Cytokinin wish their product to be considered for a
REI reduction from 12 hours to 4 hours, they must notify the Agency. For.
each product, the following information must be submitted:         .

1.     An application for Reregistration (EPA Form 8570-1).

2.     One copy of the  current product label, clearly marked to highlight the
       interim WPS REI.

3.     Two copies of the revised label, clearly marked to highlight the revised
       WPS REI.                              ,
                                    *        *

4.     The following certification statement:
             -                  1           .,—•'•"      •  •         .=-. '

       "I certify that this notification is complete in accordance with the provisions
       of the Agency's reduced REI Policy and that no other changes have been
       made to the labeling or confidential statement of formula of this product.
       I further understand that if this notification does not comply with the terms
       of the Agency's reduced REI Policy, this prqduct may be in violation of the
       Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and I may be
     1  subject to enforcement action and penalties under Sections 12 and 14 of
       FIFRA. I understand that the Agency may direct a change in the REI of a
     '  product if the Agency determines mat a change is appropriate, and that
       products may be subject to regulatory and enforcement action if the
       appropriate changes are not made."

       Notifications should be sent to:                           ','.''
        :         ' ''  '     -  ,    '      I    '  • ,       •'''*•..-

       ByU.S. Mail:
     ' '               •                "'"•';''.'         •  '
       Document Processing Desk (WPS:95-1)(BPPD)
       Office of Pesticide Programs (7504W).
       Environmental Protection Agency
       401 M Street,  S.W.           f              .
       Washington, DC 20460-0001                         "

       By Express:
                            17
-------
             Document Processing Desk (WPS:95-i)(BPPD)
             Office of Pesticide Programs (7504W)
             Room 266A, Crystal Mall 2
             1921 Jefferson Davis Highway
             Arlington, VA 22202

C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregistration Eligibility Decision
(RED). Persons other than the registrant may generally distribute or sell such products for
50 months from the date of the issuance of this RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register,  Volume 56, No. 123, June 26, 1991.

       The Agency has determined that registrants may distribute  and sell Cytokinin
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from
the date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to  meet  pre-existing Agency imposed label  changes and  existing stocks
requirements applicable to products they sell or distribute.
                                     18
-------
VI. APPENDICES
      19
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                               GUIDE TO APPENDIX B
 Appendix B contains listings of data requirements which support the reregistration for active
 ingredients within the case CytoWnin  covered by this  Reregistration  Eligibility  Decision
 Document. It contains generic data requirements that apply to Cytokinin in all products, including'
 data requirements for which a "typical formulation" is the test substance.
                                                                    *       •           '

        The data table is organized hi the following format;

        1.  Data Requirement (Column 1).  The data requirements are listed in the order in which
 they appear in 40 CFR Part 158. the reference numbers accompanying each test refer, to the test
 protocols  set in  the Pesticide Assessment Guidelines, which are available from the National
 Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.

        2•  Use Pattern (Column 2). This column indicates the use patterns for which the data.
 requirements apply. The following letter designations are used for the given use patterns:

                           A     Terrestrial food                     '   '.
     '                      B      Terrestrial feed
                           C      Terrestrial non-food  '             ,
                        ,   D     Aquatic food
                           E      Aquatic non-food outdoor
                           •F  • , Aquatic non-food industrial
                           G      Aquatic non-food residential          ,
                           H      Greenhouse food
              ,'.-.".       I  .    Greenhouse non-food
• '. •   ' •          .'-..-.'"''  *  •  '  Forestry '     ,   ;  -, '    •:'.-.    .    _',".'•"•
                      ,;     K      Residential
                           L      Indoor food                                   ;  ,
                           M     Indoor non-food
                  ^         N      Indoor medical
                           O  .    Indoor residential

       3.  Bibliographic citation (Column  3)., If' the Agency has acceptable data in its files, this
 column lists  the identifying number of each  study.  This normally is the  Master Record
 Identification (MRID) number, but may be  a  "GS" number if no MRID  number has been
 assigned.  Refer to the Bibliography appendix for a complete citation of the study.
                                          199
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4.
                        GUIDE TO APPENDIX C

 CONTENTS OF BffiLIOGRAPHY. This bibliography contains citations of all studies
 considered relevant by EPA in arriving at the positions and conclusions stated
 elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
 this bibliography have been the body of data submitted tb.EPA and its predecessor
 agencies in support of past regulatory decisions.  Selections from other sources
 including the published literature, in those instances where they have been considered,
 are included.                                                         :

 UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
 case of published materials, this  corresponds closely to an article. In the case of
 unpublished materials submitted  to the Agency, the Agency has sought to identify
 documents at a level parallel to the published article from within the typically larger  .
 volumes in which they^were submitted. The resulting "studies" generally have a
 distinct title (or at least a single subject), can stand alone for purposes of review and
 can be described with a conventional bibliographic citation.  The Agency has also
 attempted to unite basic documents and commentaries upon them, treating them as a
 single study.

 IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
 numerically by Master  Record Identifier, or "MRID number". This number is unique
 to the citation, and should be used whenever a specific reference is required. It is not
 related to the six-digit"Accession Number" which has been used to identify volumes of
 submitted studies (see paragraph 4(d)(4) below for further explanation).  In a few  -
 cases, entries added to the bibliography late hi the review may be preceded by a nine
 character temporary identifier. These entries are listed after all MRID entries. This
 temporary identifying number is also to be used whenever specific reference is needed.

 FORM OF ENTRY.  In addition to the Master Record Identifier (MRID), each entry
.consists of a citation containing standard elements followed, in the case of material
 submitted to EPA, by a description of the earliest known submission. Bibliographic
 conventions used reflect the standard of Hie American National Standards Institute
 (ANSI), expanded to provide for certain special needs.

 a     Author, Whenever the author could confidently be identified, the Agency has
       chosen to show  a personal author.  When  no individual was identified, the
       Agency has shown an identifiable laboratory or testing facility as the author.
       When no author or laboratory could be identified, the Agency has shown the
       first submitter as the author.

 b.     Document date.  The date of the study is taken, directly from the document.
       When the date is followed by a question mark, the bibliographer has deduced
       the date from the evidence contained in the document. When the date appears
       as (19??), the Agency was unable to determine or estimate the date of the
       document.
                                         205
-------
c.  .   Title.  In some cases, it has been necessary for the Agency bibliographers to
       create or enhance a document title. Any such editorial insertions are contained
       between square brackets.

d.     Trailing parentheses. For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to any self-explanatory text) the
       following elements describing the earliest known submission:

       (1)    Submission date.  The date of the earliest known submission appears
             immediately following the word "received."

       (2)    Administrative number. The next element immediately following the
             word "under" is the registration number, experimental use permit
             number, petition number, or other administrative number associated
             with the earliest known submission.

       (3)    Submitter. The third element is.the submitter. When authorship is
             defaulted to the submitter, this element is omitted.

       (4)    Volume Identification (Accession Numbers).  The final element hi the
             trailing parentheses identifies the EPA accession number of the volume
             in which the original submission of the study appears. The six-digit
              accession number follows the symbol "CDL," which stands for
              "Company Data Library." This accession number is in turn followed by
              an alphabetic suffix which shows the relative position of the study within
              the volume^ \   '
                                    206
-------
                                BIBLIOGRAPHY
 MRID
CITATION
 00074304    Hansen, K.L.; Hewett, T.A.; Beck, L.S. (1981) Primary Dermal Irritation
             Burst Yield Enhancer and Plant Growth Regulator: Project No. 1658-A.
             (Unpublished study received May 26, 1981 under 42852-2; prepared by Elars
             Bioresearch Laboratories, Inc., submitted by Dawn Corp., Denison, Iowa;
             CDL:245224-A)

.00126747    APR Agrichemical, Inc. (19??) OChemical Study: Cytex |. (Compilation;
             unpublished study received Mar 28, 1983.under 49554-1;  CDL:249893-A)

 00138091    Beck, L.; Morita, D.; Hepler, D.; et al. (19980) Rat Acute Oral Tox-   •
             icity: [#8006791081]: Project No.  1055. (unpublished study received Oct 12,
             1983 under 4F3020; prepared by Elars Bioresearch Laboratories, Inc.,
             submitted by Atlantic & Pacific Research, Inc., North Palm Beach, FL;
             CDL:072257-C).                                              ^

 00138092    Rhoads, W.; Morita, D.; Mills, V.; et al. (1979) Cytex Primary Skin Irritation:
         .    Project No. 1055. (Unpublished study receieved Oct, 1983 under 4F3020;
             prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research ,
             Inc., North Palm Beach, FL.

 00138093    Rhoads, W.; Morita, D.; MUls, V.; et al. (1979) Cytex Acute Dermal Toxicity:
   :        -Project No. 1055. (Unpublished study received Oct 12, 1983 under.4F3020;
   Y    ,    prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research,
             Inc., North Palm Beach, FL; CDL: 072257-E).                   .

 00138094    Rhoads, Wi; MiUs, V.; Morita, D.; et al. (1979) Cytex Primary Eye Irritation:
             Project No. 1055. (unpublished study received Oct 12, 1983 under 4F3020;
             prepared by Rhoads Scientific Co., submitted by Atlantic & Pacific Research,
             Inc., North Palm Beach, FL:CDL:072257-F).

 94275001    PUmpton, R. (1990) Atlantic & Pacific Research Inc Phase 3 Summary of
             MRID 00126747. Cytex Physical  Chemistry Report: File 76-2203,  Prepared
             :by Atlantic & Pacific Research,Inc. 12 p.

 94275005    Plimpton, R.(1990) Atlantici & Pacific Research Inc Phase 3 Summary of
             MRID 00138092. Cytex Primary Skin Irritation:Project 1055.  Prepared by
        v    Rhoads Scientific Company. 8 p.
                                        207
-------
208
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       The following is a list of available documents for Cytokinin that my further assist you in
responding to this Reregistration Eligibility Decision document.  These documents may be
obtained;by the following methods:
    1                 -,       •*.--,-                          .           ,, -       4
Electronic
File format:  Portable Document Format  (.PDF) Requires Adobe® Acrobat or compatible
             reader.  Electronic copies can be downloaded from the Pesticide Special Review
             and Reregistration Information System at 703-308-7224. They also are available
             on the Internet on  EPA's gopher server, GOPHER.EPA.GOV, or using ftp on
             FTP.EPA.GQV, or using WWW (World Wide Web) on WWW.EPA.GOV., or
             contact Richard King at (703)-308-8052.

       1.     PR Notice 86-5.                                                         ['.

       2.     PR Notice 91-2 (pertains to the Label Ingredient Statement).

       3.     A full copy of this RED document,                           x
         '  ' "       *.  ' '   ' •     •',''.*        ,
       4.     A copy of the fact sheet for Cytokinin.


       The following documents are part of the Administrative Record for Cytokinin and may
included hi the EPA's Office of Pesticide Programs Public Docket.  Copies of these documents
are not available electronically, but may be obtained by contacting  the person listed on the
Chemical Status Sheet.    .                  .     __;"..                           ;

       1.     Health and Environmental Effects Science Chapters.
                     - s .',,'• I ,•,'.--•            r      _

       2,     Detailed Label Usage Information System (LUIS) Report.                i-  .  '

       The following Agency reference documents are not available electronically, but may be
obtained by contacting the-person  listed on-the Chemical Status Sheet of this RED document.
                      ,'-'••     • "             "  N /                     •
       i.     The Label Review Manual.

       2.     EPA Acceptance Criteria
                                        209
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