££PA Unrt«dSt«m EmriroanMntai Protection Agency Off lea of I^Hteld* and Toxic SubtunoM Washington DC 20460 December 1985 PMicto-i Guidance for the Reregistration of Pesticide Products Containing fhion-ancte Ethyl as t*- * Active Ingredier* ------- GUIDANCE FOR THE REREGISTRATION OF PESTICIDE PRODUCTS CONTAINING AS THE ACTIVE INGREDIENT THIOPHANATE ETHYL EPA CASE NUMBER: 378 CAS: 23564-06-9 ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS WASHINGTON, D.C. 20460 DECEMBER 31, 1985 ------- TABLE OF CONTENTS Introduction 1 I. Regulatory Position and Rationale 4 II. Requirement for Submission of Generic Data 13 III. Requirement for Submission of Product—Specific Data . . 30 IV. Submission of Revised Labeling . . . . 34 A. Label Contents . . . . . 35 B. Collateral Information . . . . . . . . . . . . . . . 40 V. Instructions for Submission 41 I . ------- APPENDICES Page 1 1—1 Guide to Bibliography . . 44 11—2 Bibliography . . . . . . . . . . . 46 11—3 FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1 . 49 11—4 Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data E P A F 0 rrn 8 5 80 — 2 . . . . . . . . . . . . 50 1 1 1—1 Product Specific Data Report (End—Use Products) . 51 IV—1 40 CFR 162.10 Labeling Requirements 53 IV—2 Table of Labeling Requirements 58 IV—3 Physical/Chemical Hazards Labeling Statement. . . . 61 IV—4 Storage Instructions . 62 P1—5 Pesticide Disposal Instructions . . . . . . . . . 63 IV—6 Container Disposal Instructions . . . . . . . . . . 70 ii ------- I NTRODUCTION The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA..sec. 3(g)) directs EPA to reregister all pesticides as expeditiously as possible. To carry out this task, EPA has established the Regis- tration Standards program, which will review all pesticide products containing active ingredients first registered before January 1, 1977. Pesticides will be reviewed in use clusters which have been ranked to give earliest review to pesticides used on food and feed crops. The Registration Standards program involves a thorough review of the scientific data base underlying pesticide registrations and an identification of essential but missing studies which may not have been required when the product was initially registered or studies that are now considered insufficient. EPA’S reassessment results in the development of a regulatory position, contained in a Registration Standard, on each pesticide and its uses. The Agency may require the registrant to modify product labels to provide additional precautionary statements, restrict the use of the pesticide to certified applicators, provide reentry intervals, modify uses or formulation types, specify certain packaging limitations, or other requirements to assure that proper use of the pesticide will not result in unreasonable adverse effects on the environ- ment. The scientific review, which is not contained in this Guidance Package but is available from the National Technical Information Service, concentrates on the technical grade of the active ingredient and identifies missing generic data. However, during the review of these data we are also looking for potential haz-ards that maybe associated with the end use (formulated) products that contain the active ingredient. If we have serious concerns, we will address end use products as part of the Registration Standards program and will propose regulatory actions to the extent necessary to protect the public. EPA has the authority under FIFRA sec. 3(c)(2)(B) to require registrants to submit data that will answer our questions regarding the hazard that may result from the intended use of a pesticide. Although sec. 3(c)(2)(B) provides that all registrants are responsible for these data, the Agency generally imposes generic data requirements only on the registrants of the manufacturing use products (basic suppliers ------- of the active ingredient) and other producers who do not qualify for the formulator’s exemption.* A-producer who wishes to qualify for the formulator’s exemption may change his source of supply to a registered source, provided the source does not share ownership in common with the registrant’s firm. A registrant may do so by submitting a new Confidential Statement of Formula, EPA Form 8570—4, identifying the registered source of the active ingredient, to the appropriate Product Manager within 90 days of receipt of this Guidance Document. The chart on the following page shows what is generally required of those who do and do not qualify for the formulator’s exemption in the Registration Standards program. If you decide to request the Agency to cancel the regis- tration of any of your products subject to the requirements of this Guidance Document, please notify the Product Manager named in the cover letter, within 90 days from the receipt of this document. If you decide to maintain your product registration(s), you must provide the information described in the following pages within the timeframes outlined. EPA may issue a notice of intent to cancel or suspend the registration of any currently registered product which does not comply with the requirements set forth in this Guidance Document. You are reminded that FIFRA sec. 6(a)(2) requires you to submit factual information raising concerns of possible unreasonable adverse effects of a pesticide. You should notify the Agency of interim results of studies in progress if those results show possible adverse effects. *The formulator’s exemption applies to a registrant of an product if the source of his active ingredient(s): (1) is a registered product and (2) is purchased from a source which does not have ownership in common with the registrant’s f i rm. 2 ------- PRODUCTS SUBJECT TO THE ACTION(S) REQUIRED TO REGISTRATION STANDARDS PROGRAM MAINTAIN REGISTRATION I. Products That Do Not Qualify For The Formulator’s Exemption A. Single Active Ingredient These products must be reregis— Products* tered. To obtain reregistration, labeling, packaging and data requirements must be satisfied in accordance with the Regis- tration Standards Guidance Document. Products reregistered at this time. However, generic data required to continue the registration of the active ingredient under review, as described in the Registration Standards Guidance Document, will be required and some labeling precautions may also be required. II. Products That Do Qualify For Only when additional restric— The Formulator’s Exemption tions or labeling are needed to protect man or the environment will these products be subject to the Registration Standard requirements. Affected products will be dealt with in a variety - of ways, including but not limited to the Label Improvement Program and special intent to cancel notices. * End use products of registrants who also produce a manufacturing use product will not be required to be reregistered provided that registrant fulfills the requirements specified in the Guidance Document for manufacturing use product(s). Such end use products will be subject to the labeling changes required for products in “II” above. If there are no manufacturing use products registered by any company end use products will be required to be reregistered. NOTE: If all registrants in “I” above fail to meet the requirements in I—A and B above, then the registrants in “II” lose their right to qualify for the formulator’s exemption and become subject to the requirements in I—A and B. 3 ------- I. REGULATORY ASSESSMENT A. INTRODUCTION This chapter describes the regulatory position of the Environmental Protection Agency (“the Agency”) on thiophanate ethyl. This position is based on an evaluation of the one manufacturing use product (MP) containing thiophanate ethyl as the sole active ingredient and the registered thiophanate ethyl uses. Future requests for registrations of substantially similar products will be covered by this standard. After briefly describing the chemical and its uses, this chapter presents the regulatory position and rationale, the criteria for registration, the acceptable ranges and limits, and the labeling requirements for manufacturing use products (MP5) and end use products (EPs). B. DESCRIPTION OF CHEMICAL “Thiophanate” is the common name (British Standards Institution, International Organization for Standardization) for diethyl 4,4’—o—phenylene bis [ 3—thioallaphanate]. Trade and other chemical names for this compound include 1,2—bis [ 3—(ethoxy— carbonyl)—2—thioureido]benzene, diethyl [ 1 ,2—phenylerte bis (irninocarbonothioyl)]—bis—(carbamate), Topsin, Cleary’s 3336, Cercobin, Topsin E, NF—35, and TD—1604. The Chemical Abstracts Service (CAS) Registry Number is 23564—06—9 and the Office of Pesticide Program’s Internal Control Number (EPA Shaughnessy number) is 103401. Thiophanate ethyl is a broad spectrum systemic fungicide registered for use on turf (golf courses), roses, flowers, ornameritals, and shade trees. Technical thiophanate is manu— factured--by Nippon Soda Co. Ltd., Japan and is marketed in the United States by Penriwalt Corporation. There are four formulations of thiophanate ethyl, 2 wettable powders (16.67 percent and 50 percent) and 2 flowable concentrates (1 .09 lb/gal and 4 lb/gal). Application rates range from 1.36 to 10.9 lbs ai per acre for turf uses and 0.25 lb to 0.75 lb ai per 100 gallons for ornamental uses. 4 ------- C. REGULATORY POSITION AND RATIONALE Based on a review and evaluation of the available data and other relevant information on thiophariate ethyl, the Agency has made the following determinations. 1 . None of the risk criteria set forth in Title 40 Code of Federal Regulations (CFR) §162.11 have been met or exceeded by thiophanate ethyl. Rationale : a. Thiophanate ethyl is not oncogenic in rats or mice. A chronic toxicity/oncogenicity study in rats which resulted in reduced body weight in both sexes, thyroid follicular hypertrophy in older male rats, and elevated liver weights and liver—to—body weight ratios in males, indicated a LEL (lowest effect level) of 1000 ppm (50 mg/kg/day) and a NOEL (no observable effect level) of 200 ppm (10 mg/kg/day) . Tumors were observed predominantly in older animals, but there were no statistically significant increases in their incidences. A mouse oncogenicity study did not indicate an oncogenic effect for thiophanate ethyl at doses tested up to 2000 ppm (300 mg/kg/day). b. Methyl benzimidazole carbamate (MBC), which is a metabolite of the fungicide thiophanate methyl and a structural analog of ethyl benzimidazole carbamate (EBC), the metabolite of thiophartate ethyl, is associated with increased liver tumors in mice. However, there are no studies available suggesting that EBC similarly induces tumors in laboratory animals, and oncogenicity studies with thiophanate ethyl and thiophanate methyl do not suggest an oncogenic potential similar to that of MBC for either fungicide. Because of the low potential for human exposure to thiophanate ethyl from current uses, exposure to EBC is also expected to be low, even though we do not have data which show the proportion of thiophanate ethyl that is likely to be metabolized to EBC. If uses are expanded, thereby increasing potential human exposure, data to determine the proportion of thiophanate ethyl that is metabolized to EBC in animals, and data on the toxicity of EBC may be required to complete a hazard assessment. c. Thiophanate ethyl has moderate to low acute toxicity to humans. Acute toxicity studies indicate Toxicity Category III for acute inhalation (LC 50 = 6.7 mg/L), acute dermal (LD 50 > 15,000 mg/kg), and primary skin irritation (non—irritating), and Toxicity Category IV for acute oral (LD5O > 15,000 mg/kg), and primary eye irritation (non—irritating). 5 ------- 2. The Agency is requiring the submission of teratology, mutagenicity, and repeated dermal toxicity studies. Rationale : Registrants of thiophanate ethyl products were not previously required to submit the above studies to the Agency. Teratology studies in two mammalian species are required to assess the teratogenic potential of thiophanate ethyl. Mutagenicity studies that evaluate the potential of thiophanate ethyl to cause gene mutations, chromosomal damage, or other related effects are also required, and a 21—day dermal toxicity study in rabbits is required to fully assess the dermal toxicity of thiophanate ethyl. 3. Since there are no food/feed uses registered for thiophanate ethyl, plant and livestock metabolism, residue, and feeding data for thiophanate ethyl are not required at this time. Rationale : To date there have been no U.S. tolerances or registrations on food/feed items for thiophartate ethyl. All currently registered labels contain a restriction prohibiting grazing on treated turf or feeding clippings to livestock. In the event that future food uses for thiophanate ethyl are proposed, all appropriate metabolism, residue, and feeding data will be required, pursuant to 40 CFR §158. 4 . The Agency is requiring the submission of studies to fully assess the environmental fate of thiophanate ethyl and the exposure of human and nontarget organisms to thiophanate ethyl. Rationale : Registrants of thiophanate ethyl products were not previously required to submit environmental fate studies. The following studies are required to fully assess the environ- mental fate and transport of, and the potential exposure to thiophanate ethyl: hydrolysis studies; photodegradation studies in water; aerobic soil metabolism studies; leaching or adsorption/ desorptiort studies; terrestrial field dissipation studies; and accumulation studies in fish. 5. The Agency may require additional avian toxicity data depending on the outcome of the required environmental fate studies. Rationale : Thiophanate ethyl has an extremely low acute toxicity to birds. Thiophanate ethyl has an acute oral LD 50 to bobwhite quail greater than 2510 mg/kg and LC5ij values of greater than 5620 ppm to both mallard ducks and bobwhite quail. If after receipt and evaluation of environmental fate data it is concluded that avian species are subject to significant or recurrent exposure to thiophanate ethyl and EBC, the Agency may request a complete avian toxicity battery on EBC and avian reproduction studies on thiophanate ethyl and EBC. 6 ------- 6. The Agency is requiring data to evaluate the acute toxicity of EBC to aquatic species, and to evaluate the toxicity of thiophanate ethyl and EBC to channel catfish in particular. Depending on the outcome of the environmental fate studies, additional aquatic toxicity testing may be required. Rationale : Thiophanate ethyl has moderate acute toxicity to fish and aquatic invertebrates. Thiophanate ethyl has an LC 50 of 2.6 ppm to bluegill sunfish, 2.26 ppm to rainbow trout, and 2.6 ppm to Daphia magna . However, studies performed with the chemically related compounds, thiophanate methyl and benomyl, show a toxicity to channel catfish in the “very highly toxic” range. Furthermore, the primary rnetabolite of both these compounds, NIBC, is also very toxic to channel catfish. There is reason to suspect that thiophanate ethyl may be more highly toxic to ictalurid fishes (catfish family) than to other types of fish, and therefore, a 96—hour LC 50 on channel catfish using thiophanate ethyl and EBC is being required. As there are also no data available to assess the acute aquatic toxicity of EBC, these data must also be submitted. If after receipt and evaluation of environmental fate data it is concluded that there may be significant or recurrent exposure to aquatic habitats, chronic aquatic testing on both thiophanate ethyl and ethyl benzimidazole carbamate may be required in order to complete this hazard assessment. 7. Based on available data, the currently registered uses of thiophanate ethyl should not result in adverse effects to endangered species. A formal consultation with the OES (Office of Endangered Species) may be initiated if data to be generated indicate risks to endangered species. Rationale : There are two ictalurid finfishes (catfish family) on the endangered species list, the scioto madtom and the yellowfin madtom. If, after the receipt of additional data thiophanate ethyl proves to be highly toxic to ictalurids and if significant aquatic exposure seems likely, a formal consultation with the Office of End.angered Species will be initiated. 7 ------- 8. Manufacturing use pesticide products containing thiophanate ethyl as a sole active ingredient may be registered for sale, distribution, formulation, and use in the United States, subject to the terms and conditions specified in the Standard. Registrants must provide or agree to develop addLtional data, as specified in the tables, in order to maintain existing registrations or to permit new thiophanate ethyl registrations. Rationale : In the absence of evidence indicating that the use of a pesticide would cause unreasonable adverse effects to the environment, the Agency can register or allow the continued registration of a product for which data are missing or inadequate. Issuance of this Standard provides a mechanism for identifying such data needs. Data submitted to fill these gaps will be reviewed and evaluated. The Agency will then determine if they will affect registration(s) of thiophanate ethyl. 9. In order to meet statutory standards under FIFRA, MP labels must bear. a statement regarding discharge to bodies of water and sewer systems (see Section F. Labeling requirements). Rationale : These precautions will minimize the discharge of effluents from manufacturing plants and also meet the Effluent Guideline requirements 10 . No protective clothing statements or reentry intervals are required. Rationale : Thiophanate ethyl has moderate to low acute toxicity to humans. Acute toxicity studies indicate Toxicity Category III for acute inhalation (LC 50 = 6.7 mg/L), acute dermal (LD 50 > 15,000 mg/kg), and primary skin irritation (non—irritating), and Toxicity Category IV for acute oral (LD 50 > 15,000 mg/kg), and primary eye irritation (non—irritating). 11. EP labels will be required to bear a revised environmental hazard statement regarding application to bodies of water. This statement however, may be subject to further revisions (see Section F. Labeling requirements). Rationale : After evaluation of the required environmental fate data and ecological effects data on the parent compound and its metabolite EBC, the basic environmental hazard statement may need to be further revised to protect the non—target species. 8 ------- 12. EP labels will be required to maintain the grazing restriction statement (See Section F. Labeling Requirements). Rationale : There are currently no established U.S. tolerances for thiophanate ethyl on food/feed items. This restriction is neces ary to prevent the occurrence of secondary residues in meat and milk products. 9 ------- D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT To be subject to this guidance document, MPs must meet the following condition: 1 . Contain thiophanate ethyl as the sole active ingredient and, 2. Conform to the acute toxicity limits, product composition, and use pattern requirements listed in Section E of this document. In order to meet applicable statutory standards under FIFRA, registration of products subject to this document must comply with all terms and conditions described in it, including commitment to fill data gaps on a schedule acceptable to EPA and consistent with that required of the present registrant. All registrants and applicants for registration under this document must follow the instructions contained in this document and complete and submit the appropriate forms within the specified time. E. ACCEPTABLE RANGES AND LIMITS 1. Product Composition Standard Each MP formulation proposed for registration must be fully described with an appropriate certification of limits. In addition, the active ingredient found in the MP5 must be substantially similar to that in the currently registered product. Any MP not meeting these requirements will be considered a new product and will not be registerable under this standard. 2. Acute Toxicity Limits The Agency will consider registration of products containing thiophanate ethyl, provided that the product labeling bears appropriate precautionary statements for the acute toxicity category in which each product is placed. 3. Use Patterns: To be registered under this standard, MPs containing thiophanate ethyl must be labeled for formulation only into end-use fungicide products for use on turf (golf courses), roses, flowers, ornamentals, and shade trees. 10 ------- F. REQUIRED LABELING All technical grade products, MPg, and EPs containing thiophanate ethyl must bear appropriate labeling as specified in 40 CFR § 162.10. Other portions of this guidance package contain specific information regarding label requirements. In addition to the requirements stated in 40 CER § 162.10, the following information must appear on the labeling of all products in the channels of trade after June 30, 1987 . 1 . Ingredient Statement The ingredient statement for MPs and EPs must list the active ingredient as: Thiophanate ethyl: diethyl 4,4’—o—phenylene bis [ thio— allophanatel , % 2. Precautionary Statements Manu facturing—tJse Product Statements All products intended for formulation into EPs must bear the following environmental hazard statement: “Do not discharge effluent containing this product directly into lakes, streams, ponds, estuaries, oceans or public waters unless this product is specifically identified and addressed in a National Pollutant Discharge Elimination System (NPDES) permit. Do not discharge effluent containing this product into sewer systems without previously notifying the sewage treatment plant authority. For guidance, contact your State Water Board or Regional Office of the Environmental Protection Agency.” End—Use Product Statements The following environmental hazard statement must appear on all EP products: “Do not apply directly to water or wetlands (swamps, bogs, marshes, and potholes). Do not contaminate water by cleaning of equipment or disposal of waste.” The following feeding/grazing restriction must appear on all EP products: “Do not graze treated area or feed clippings to livestock.” 11 ------- G. TOLERA ’.1CE REASSESSMENT To date there have been no U.S. tolerances or registrations on food/feed items for thiopnanate ethyl. 12 ------- REQUIREMENT FOR SUBMISSION OF GENERIC DATA A. This portion of the guidance document is a Notice issued under the authority of FIFRA sec. 3(c)(2)(B). The tables following this section list the data required for maintaining the registrability of each product. EPA has determined that additional generic data described in Table A must be submitted to EPA for evaluation in order to maintain in effect the registration(s) of your product(s) identified as an attachment to the cover letter accompanying this guidance document. As required by FIFRA sec. 3(c)(2)(B), you are required to take appropriate steps to comply with this Notice. EPA may suspend the registration of each of those products unless, within the specified time, you have informed EPA how you will satisfy the requirements of this Notice. Any such suspension will remain in effect until you have complied with the terms of this Notice. B. What Generic Data” Must be Submitted . You may deter- mine which generic data you must submit by consulting Table A at the end of this chapter. That table lists the generic data needed to evaluate the continued registrability of all products, and the dates by which the data must be submitted. The required studies must be conducted in accordance with EPA approved protocols (such as those contained in the Pesticide Assessment Guidelines 2/ or data collected under the approved protocols of. the Orgaritzation for Economic Cooperation and Development (OECD). If you do not wish to develop data in support of certain uses appearing in your labeling, you may delete those uses at the time you submit your revised labeling. For certain kinds of testing (generally ecological effects), EPA requires the test substance to be a “typical formulation,” and in those cases EPA needs data of that type 1/ Generic data pertain to the properties or effects of a particular ingredient, and thus are relevant to an evaluation of the risks of all products containing that ingredient, regardles of the product’s unique composition or specific use. Product— specific data relate only to the properties or effects of a product with a particular composition (or a group of products with closely similar composition). 2/ The Pesticide Assessment Guidelines are available in hard copy or microfiche from the National Technical Information Service, 5285 Port Royal Road, Springfield, Va. 22161. 13 ------- for each major formulation category (e.g., emulsifiable concen- trates, wettable powders, granulars, etc.) These are classified as generic data and when needed are specified in Table A. EPA may possess data on certain “typical formulations” but not others. Note : “Typical formulation” data should not be confused with product—specific data (Table B) which are required on each formulation. Product—specific data are further explained in Chapter III of this document. C. Options Available for Complying With Requirements to Submit Data Within 90 days of your receipt of this Notice you must submit to EPA a completed copy of the form entitled “FIFRA Section 3(c)(2)(B) Summary Sheet” (EPA Form 8580—1, Appendix 11—31 for each of your products. On that form you must state which of the following methods you will use to comply with the requirements of this Notice: 1. (a) Notify EPA that you will submit the data, and (b) either submit the existing data you believe will satisfy the requirement, or state that you will generate the data by conducting testing. If the test procedures you will use deviate from (or are not specified in) the Pesticide Assessment Guidelines or protocols contained in the Reports of Expert Groups to the Chemicals Group, Organization for Economic Cooperation and Development (OECD) Chemicals Testing Programme, you must enclose the protocols you will use. OR 2. Notify EPA that you have entered into an agreement with one or more other registrants to jointly develop (or share in the cost of developing) the data. If you elect this option, you must notify EPA which registrant(s) are parties to the agreement. OR 3. File with EPA a completed “Certification of Attempt to Enter Into an Agreement With Other Registrants for Develop- ment of Data” (EPA Form 8580—6, Appendix II_4)*/ / FIFRA sec. 3(c)(2)(B) authorizes joint development of data by two or more registrants, and provides a mechanism by which parties can obtain an arbitrator’s decision if they agree to jointly develop data but fail to agree on all the terms of the agreement. The statute does not compel any registrant to agree to develop data jointly. (Footnote continued on next page) 14 ------- OR 4 . Request that EPA amend your registration by deleting the uses for which the data are needed. (This option is not available to applicants for new products.) OR 5. Request voluntary cancellation of the registration(s) of your products for which the data are needed. (This option is not available to applicants for new products.) D. Procedures for Requesting Changes in Testing Methodology and Extensions of Time EPA recognizes that you may disagree with our conclusions regarding the appropriate ways to develop the required data or how quickly the data must be submitted. If the test procedures you plan to use deviate from (or are not specified in) the registration guidelines or protocols contained in the reports of the Expert Groups to the Chemical Groups, Organization for Economic Cooperation and Development (OECD) Chemicals Testing Programme, you must submit the protocol for Agency review prior to the initiation of the test. If you think that you will need more time to generate the required data than is allowed by EPA’S schedule, you may submit a request for an extension of time. The extension request must be submitted in writing to the Product Manager. (Footnote continued from previous page) In EPA’s opinion, joint data development by all regis -. trants subject to a data requirement or a cost—sharing agreement among all such registrants is clearly in the public interest. Duplication of testing could increase costs, tie up testing facilities, and subject an unnecessarily large number of animals to testing. AS noted earlier, EPA has discretion to suspend the registration of a product when a registrant fails to submit data required under FIFRA Section 3(c)(2)(B). EPA has concluded that it should encourage joint testing rather than duplicative testing, and that suspension should be withheld in certain cases. to further this goal. Accordingly, if (1) a registrant has informed us of his intent to develop and submit data required by this Notice; and (2) a second registrant informs EPA that it has made a bona tide offer to the first registrant to share in the expenses of the testing (on terms to be agreed upon or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined to agree to enter into a cost—sharing agreement, EPA will not suspend the second firm’s registration. 15 ------- The extension request should state the reasons why you believe that an extension is appropriate. While EPA considers your request, you must strive to meet the deadline for submitting the required data. 16 ------- TABLE A GENERIC D ATA R U1REME II FOR ThIOPHANATE ETHYL Data Must Be Guideline Citation and Test Guidelines Are Data Submitted Within Name of Test Substance Status Required Yes Reference Citation Tine Frames Below 1/ Liste §158.120 Product Chemistry Product Identity: 61-1 —. Identity of Ingredients 61—2 — Description of Beginning Materials ar i Maruifacturir j Process 61—3 — Discussion of Formation of Impurities Analysis and Certification of Product Ingredients 62—1 — 62—2 — 62—3 — 00089068 ‘ItAI TGAI I 3AI TGAI I AI TGAI ‘IXA I ‘I 3AI B 3AI ]X AI R R R R R R R R R R NA Preliminary Analysis Certification of Ingredient Limits Analytical Methods to Verify Certified Limits Physical and Chemical Characteristics 63-2 — Color 63-3 — Physical State 63-4 - Odor 63—5 — 63—6 — 12 Months 12 Months 6 Months 6 Months 12 Months El [ Xl [ Xl [ xl [ Xl [ X I I [ 1 III [ 1 III [ 1 [ X I [ I [ — I I [ I [ I [ 1 (XII [ Xl [ Xl Ix [ II Melting Point Boiling Point 00068776 00068776 00068776 00068776 17 ------- TABLE A GENERIC ( TA R UIREMENTIS FOR THIOPI-IANATE ETHYL Data ITaist Be Guideline Citation and Test Guidelines Are Data Submitted Within Narr of Test Substance Status Required Yes ND Reference Citation Tine Fran s Listed Below 1, §158.120 Product Chemistry (Continued) Physical and Chemical Characteristics (Continued) 63—7 — Density, Bulk Density, or ¶IXA1 R (1 (X l 00068776 — Specific Gravity 63—8 — Solubility 63—9 — Vapor Pressure 6 3—10 - Dissociation constant KA 1 ¶ AI TCAI R R R lx i I I [ Xi Ii [ X l (I 6 Months 6 Months 6 Months 63—11 - Octanol/water partition coefficient ¶R3AI R [ ] 11 6 Months 63-12 - p t - I 63—13 — Stability 1XM ‘j1 Aj R R [ ) 11 [ I (Xl 6 Months 0088444 TGAI = Technical Grade of the Active Ingredient; PAl = Pure Active Ingredient; R = Required; CR = Conditionally Required 1/ Data trust be submitted within the indicated tine frane, based on the date of the Guidance [ )Dcunent. o 6 Month the Date is June 30, 1986 o 12 Month the Date is December 31, 1986 18 ------- TABLE A GENERIC DATA RB)UIREMENI 3 I OR ThIOPHANATE ETHYL Does EPA Have Data To Satisfy This Require- n nt? (Yes, No or Partially) B 4J N/A 4/ N/A B,F No 4/ N/A 4/ N/A 4/ NI/A B, F 4/ N/A 4/ N/A 1/ Data Requiren nt Composition Use 2/ Pattern Must Additional Data Be Submitted Under Bibliographic FIFRA § 3(c)(2)(B)? Citation - Tine Fran for Data Sut üssion 3/ 1 AI or PAIRA B,F Yes No ltM 1 AI UA 1 ‘IIAI §158.130 Environnental Fate DEY RADATION STIJDI ES-LAB : 16 1—1 — Hydrolysis Photodegradat ion 161—2 — In water 161—3 — On soil 161—4 — In Air METABOLISM STUDI ES—LAB : 162—1 — Aerobic Soil 162—2 - Anaerobic Soil 162—3 — Anaerobic Aquatic 162—4 — Aerobic Aquatic N )BILITY STUDIES : 163—1 — Leachir and Adsorpt ion/Desorpt ion 163—2 — Volatility (Lab) 163—3 — Volatility (Field) or PAIRA or PAIRA or PAIRA or PAIRA or PAIRA 6 Months 6 Months 24 Months 6 Months Yes Yes Yes ICAI or PAIRA IGP 1 J or PAIRA IGAI or PAT RA TEP TEP No 19 ------- TABLE A GENERIC DATA REI)UIREMEN S EOR ThIOPHAN TE E FWL E es EPA Have Must Additional Data Data To Satisfy Be Submitted Under 1/ Use 2/ This Require— Bibliographic FII A § 3(c)(2)(B)? Data Requirerrent Composition Pattern ment? (Yes, or Partially) t’b Citation Time Frame for Data Submission 3/ §158.130 Environmental Fate — Continued DISSIPATION SIUDIES — FIELD ; 164—1 — Soil TEP B Yes 24 nonths 4 - _I 164—2 — uatic (Sediment) TEP N/A 4/ 164—3 — Forestry TEP N/A 164—4 - Combination and 5/ Tank Mixes 4/ 164—5 - Soil, Long term TEP N/A ACCUMULATION SIUDI ES : 165—1 — Rotational Crops 4/ (Confined) PAIRA N/A 165-2 - Rotational Crops 4/ (Field) TEP 4 165-3 — Irrigated Crops TEP WiC 165—4 — In Fish TGAI or PAIRA B Yes 6 mcnths 165-5 — rn Njuatic n-Target 4/ Organisms TEP N/A 6/ 158.140 Reentry Protection 20 ------- ThBLE t GENERIC DATA REI UIREMEtSTFS I?’OR ThIOPUAN1 ATE I fHYL §158.130 Environn ntal Fate — Continued 1/ Canposition: ICAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end—use product. 2/ The use patterns are coded as folk ,s: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=I cjuatic, Food Crop; D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Exxnestic C itdoor; I=Indoor. 3/ Data must be sub’nitted within the indicated time frame, based on the date of the Guidance Document. o 6 Month We Date is June 30, 1986 o 24 Month We Date is December 31, 1987 4/ Not applicable. Data are not required to support current registered uses. 5/ Data requirements for ccznbination products and tank mixes are not addressed in this standard. 6/ The criteria for reentry data requirements as defined in 40 CFR Part 158.140 are not met for this chemical. 21 ------- U58.135 Toxicology TABLE A GENERIC tY TA REOUIREMENTS I OR ThIOPHAMkTE ETF1YL Does EPA Have Data Th Satisfy This Require- n nt? (Yes, No or Partially) 5/ 00032673 No 6/ No Yes 7/ No 1/ Data Requireu nt Composition Use 2/ Pattern Must Additional Data Be Subnitted Under Bibliographic FII!i A 3(c)(2)(B)? Citation - Time Frau for Data Su ission 3/ ICA I TGAI TGAI ICA I lY AI 1 AI B, F B, F B, F B, F B, F B, F ACUTE TESTIt C : 81—1 — Acute Oral Toxicity — Rat 81—2 — Acute Dermal Tbxicity — Rabbit 81—3 — Acute Inhalation Toxicity — Rat 81—4 — Eye Irritation — Rabbit 81—5 — Dermal Irritation — Rabbit 81—6 — Dermal Sensitization — Guinea Pig 81—7 — Acute Delayed Neurotoxicity — Hen SUBCHF ONIC TESTIM : 82—1 — 90-Day Feeding — Rodent, and — Non-rodent (Dog) 82-2 — 21—Day Dermal — Rabbit 82-3 — 90—Day Dermal — Rabbit Yes 00089070 tb Yes 00089070 tb Yes 00098045 Yes 00098046 tb Yes 00098047 No Yes 00089070 TGAI B,F ‘I AI TGAI TGAI AI 4/ No B, F B, F B, F B, F 6 Months 22 ------- §158.135 Tbxicology — Contiruied SUBCURONIC TE STI (Cont’ d.) : 82—4 — 90—Day Inhalation: — Rat 82—S — 90—Day Neurotoxicity: — Henfllammal CHRONIC TESTI1 C : 83—1 — Chronic Toxicity— 2 species: — Rodent, and — Non—rodent (Dog) 83—2 — Oncogenicity — 2 species: — Rat (preferred), and - Maise (preferred) 83—3 — Teratogenicity — 2 species: — Rat — Rabbit 83-4 — Reproduction - Rat 2—generation TABLE A GENERIC DATA REI)UIREMENIS Ft)R ¶IHIOPHANATE E’TI-IYL Does EPA Have Data To Satisfy This Require— ment? (Yes, ND or Partially) Yes Yes 9/ No / Data Requirerrent Composition Use 2/ Pattern Must Additional Data Be Subnitted Under Bibliographic FIFRA § 3(c)(2)(B)? Citation Time Frarre for Data Sut ission 3/ 8/ TGAI B,F No 4/ 1 AI B, F ND ND Yes ND 00032673 No 6/ No Yes 00032673 Yes 00032674 R3AI AI 1 AI TGAI P3A1 AI AI B, F B, F B, F B, F B, F B, F B, F 9 Nonths 9 Months 23 ------- §158.135 Thxicology — Continued MtJTN3ENICITY TE TI 84—2 — Gene Mutation (An s Test) 84—2 — Structural Chron somal Aberration 84—4 — Other Genotoxic Effects SPECIAL TE TI 85—1 — General Metabolism 85—2 — Dermal Penetration 86—1 — Domastic Animal Safety 6 Months 6 Months Yes 6 Months 10/ Mo 11/ Mo 12/ Mo / Use 2/ Data Requiremant Composition Pattern TABLE A GENERIC DATA REOUIREMENTS DR THIOPHANP TE E HYL Does EPA Have Data To Satisfy This Require— mant? (Yes, Mo or Partially) Must AddtEional Data Be Subnitted Under Bibliographic FIFRA § 3(c)(2)(B)? Citation Tima Frait for Data Su nission 3/ l 3AI B, F Mo Yes IXAI B, F Yes I CAI B, F PAl or PAIRA B, F Mo Choice B,F Mo 24 ------- TABLE ( GENERIC DATA REX)UIREMENIS FOR THIOPUANATE ETHYL §158.135 lbxicolocjy — Continued 1/ Canposition: PAl = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several test substances determined on a case— ’—case basis. 2/ The use patterns are coded as fo1lci s: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop; D=Pquatic, Non—Food; E=Greenhcuse, Food Crop; F=Greenhouse, Non—Food; G=Forestry; H=Danestic C jtdoor; I=Indoor. 3/ Data must be sub’nitted within the indicated time franb , based on the date of the Guidance t)Dcument.... o 6 Month the Date is June 30, 1986 o 9 Month ihe Date is September 30, 1986 4/ Test material is not an organophosphate or degradation pro&*ct thereof, and it is not structurally related to a kno4n acute delayed neurotoxic substance. 5/ Satisfied by chronic rodent studies. 6/ Not required to support registration for non—food uses. 7/ No direct application to the skin or prolonged dermal exposures are expected with uses of thiophanate ethyl. 8/ Repeated inhalation exposure to toxic concentrations is not likely under normal use conditions. / Not expected to result in human exposure over a portion of the human lifespan which is significant in terms of — frequency of exposure, magnitude of exposure, or the duration of exposure. 10/ Only required in conjunction with chronic feeding or oncogenicity studies which are not required for this use pattern. 11/ Thiophanate ethyl has noderate to lo acute toxicity to humans and its limited use pattern will not result in a significant amount of dermal exposure. 12/ The likelihood of dcii stic animal exposure to thiophanate ethyl is minimal. 25 ------- 1/ Ccxnpos it ion 1 AI 5/ EBC l AI 5/ EBC N/A Use Pattern Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Submission 3/ ND 6/ Reserved ND 6/ Reserved ta Requirement TABLE A GENERIC DATA REOUIREMEN S FOR NIOPHANATE ETHYL Lbes EPA Have Data To Satisfy This Require- ment? (Yes, ND Bibliographic Citation . 58.145 Wildlife and cjuatic Organisms AVIAN AND MAMMALIAN TESTIt 71—1 — Acute Avian Oral Toxicity 71—2 — Avian Subacute Dietary Toxicity - Upland Game Bird, and — Waterfc zl 71—3 - Wild Maninal Toxicity ND 7/ TGAI B, F Yes 4/ 00085643 TEP B, F Yes 00050517 5/ EI B,F B, 7/ F Yes 00079196 B,F ND B, F Yes 00079197 B,F ND 6/ Reserved 26 -------An error occurred while trying to OCR this image. ------- TABLE A GENERIC DT TA REOUIREMENIS EOR T1-IIOPHANPtTE ETFFWL Does EPA Have Must Additional Dat Data To Satisfy Be Subnitted Under )ata Requirenent 1/ Composition Use 2/ Pattern This Require— nent? (Yes, or Partially) No Bibliographic Citation FIFRA § 3(c)(2)(B)? Tine Frane for Data Su inission 3/ U58.145 Wildlife and P uatic Organisms — Continued 7/ 72-2 - Acute Toxicity to TGAI B, F Yes 00079200 N D Fresh iater Invertebrates 5/ EBC B, F Yes 9 Months 12/ 72-3 - Acute Toxicity to TGAI B Estuarine and Marine Organisms 6/ 72-4 — Fish Early Life Stage, IOAI B Reserved and 5/ 6/ — Aquatic Invertebrate EBC B Reserved Life—Cycle 13/ 72—5 - Fish - Life—Cycle TGAI B No 6/ 72—6 — Aquatic Organism B Reserved A ccunuilation 5/ EBC B ND Reserved 6/ 14/ 72—7 — Simulated or Actual TEP B Reserved Field Testir j for Aquatic Organisms 28 ------- TABLE A GENERIC DATA R OUIREMEt I1’S FOR TI-IIOPHANATE Efl’HYL §158.145 Wildlife and lcjuatic Organi n — Continued 1/ Ccuiposition: ‘IGAI = Technical grade of the active ingredient; PAl = pure active ingredient; TEP = Typical end—use product; 2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, n—Food Crop; C=Aquatic, Food Crop; D=Aquat ic, Isbn-Food; E=Greenhouse, Food Crop; F=Greenhouse, tsbn— Food; G=Forestry; H=Domest ic Outdoor; 1= Indoor. 3/ Data must be subnitted within the indicated time frame, based on the date of the Guidance Document. ° 9 Month [ lie Date is September 30, 1986 4/ Although this study exists and is acceptable, currently there are no requirements for formulated product testing. 5/ EBC is the primary metabolite of thiophanate ethyl. 6/ Pending review of environmental fate data by EAB. 7/ Study is required to support the MP formulated into these end use products. 8/ Pending review of environmental fate data and subsequent lower tier EER data, e.g., studies on EBC. 9/ Only one fish study, either on a coldwater or a warm ater fish, is required to support the MP formulated into these end use products. 10/ A 96—hour LC test performed on the channel catfish using the parent compound thiophanate ethyl is required. (Chemically related compounds have been shown to be very highly toxic to channel catfish. 11/ Two 96—hour LC tests, the standard 96—hour LC test performed on bluegill sunfish, and a second — LC test performed on channel catfish. The second study is required because chemically related compounds have been sbown to be very highly toxic to channel catfish. 12/ Product not intended for direct application to marine or estuarine environment. 13/ Product not intended for direct application to water. 14/ Residue nonitoring with caged catfish. 29 ------- III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA Note: Unless stated otherwise in Section I, Regulatory Position and Rationale, this Section applies only to manufac- turing use products, not to end use products. A necessary first step in determining which statements must appear on your product’s label is the completion and submission to EPA of product—specific data* listed on the form entitled “Product Specific Data Report” (EPA Form 8580—4, Appendix 111—1) to fill gaps identified by EPA concerning your product. Under the authority of FIFRA sec. 3(c)(2)(B), EPA has determined that you must submit these data to EPA in order to reregister your product(s). All of these data must be submitted not later than six months after you receive this guidance document. Table B——Product—Specific Data Requirements for Manufacturing Use Products——lists the product specific data you must submit. Data that are required to be submitted are identified in the column of those tables entitled “Must Data By Submitted Under §3(c)(2)(B).” / Product specific data pertain to data that support the !ormulation which is marketed; it usually includes product chemistry data and acute toxicity data. 30 ------- TABLE B PL )DUCF SPECIFIC DATA REX)UIREMENI’S L0R MANUFAC1IJRII’&-WE PIODUCIS ffAININ ThIOPIIANATE muyL 2 / Data Must Be Guideline Citation and Test Guidelines Are Data Reference Submitted Within r ama of Test Substance Status R uired Yes Citation Tine Framas Below 1/ Listed §158.120 Product Chemistry Product Identity : 61—1 — Product Identity and Disclosure MP R [ =1 IX] 00089068 of Ingredients 61—2 — Dascription of Beginning Materials MP R L x ] [ 1 ___________ 12 Months and Manufacturing Process 61—3 - Disoission of Formation of NP R i ii LI ___________ 12 Months Impurities Analysis and Certification of Product Ingredients 62—1 — Preliminary Analysis R LX] ____________ 6 Months 62—2 — Certification of Limits NP R fl ___________ 6 Months 62—3 — Analytical Methods to Verify MP R [ X I 1] ___________ 12 Months Certified Limit 31 ------- TABLE B PRODUCt’ SPECIFIC DATA REZ)UIREMENI’S I t)R MAF RJFAC’11JRfl&-WE PRODUCt’S COI fl ’AINIt’ 3 ThIOPU NNr 1 ( fl’UYL 2 / Data Must Be uideline Citation and Test Guidelines Are Data Footnote Submitted Within Jaiie of Test Substance Status Required Yes t b Number Tine Frau s Belc i 1/ Listed 158.120 Product Chemistry (Continued) hysical and Chemical Characteristics 63-12 - pt-I MP CR ( 1 11 ___________ 6 Months Other Requiren nts : 64— 1 — Submittal of samples MP CR [ X l ii 3 6 Months MP = Manufacturing—use Product; R = Required; CR = Conditionally Required 1/ Data must be submitted within the indicated tine frari , based on. the date of the Guidance E)Dcument. o 6 Month the Date is June 30, 1986 o 12 Month the Date is December 30, 1986 2/ The technical (T) also serves as a manufacturing—use product. 3/ If needed, the Agency will request the samples. 32 ------- TABLE B P [ )DUer SPECIFIC DP TA RB UIREMENTS JR MANUFACTURII’&-WE P )DUC1’S CflNTAINI CHEMICAL THIOPHANATE fl-1YL Data Requiremant L/ Composition Does EPA Have Data To Satisfy This Require— mant? (Yes, ND or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA § 3(c)(2)(B)? Time Frame for Data Subnission §158 .1 35 Toxicology ACUTE ThSTIFSC 81—1 — Acute Oral Toxicity — Rat MP Yes 00089070 ND 81—2 — Acute Dermal Toxicity - Rabbit MP Yes 00089070 ND 81—3 — Acute Inhalation Toxicity — Rat MP Yes 00098045 ND 81-4 — Primary Eye Irritation — Rabbit MP Yes 00098046 ND 81—5 - Primary Dermal Irritation — Rabbit MP Yes 00098047 ND 81—6 — Dermal Sensitization — Guinea Pig MP Yes 00089070 ND 1/ Composition: MP = Manufacturing—use product. 33 ------- IV. SUBMISSION OF REVISED LABELING FIFRA requires each product to be labeled with accurate, complete and sufficient instructions and precautions, reflecting the results of data concerning the product and its ingredients. Labeling requirements are set out in 40 CFR 162.10 (see Appendix IV—1) and are summarized for products containing this active ingredient as part of this Guidance Document (See AppendixlV—2). Applications submitted in response to this notice must include draft labeling for Agency review. If you fail to submit revised labeling information complying with this section (supplemented by requirements described in Section I, Regulatory Position and Rationale), EPA may issue a notice of intent to cancel the registration under FIFRA sec. 6(b)(1). 34 ------- A. Label Contents 40 CFR 162.10 requires that certain specific labeling statements appear at certain locations on the label. This is referred to as format labeling . Specific label items listed below are keyed to Appendix IV—2. Item 1. PRODUCT NAME — The name, brand or trademark is required to be located on the front panel, preferably centered in the upper part of the panel. The name of a product will not be accepted if it is false or misleading. Item 2. COMPANY NAME AND ADDRESS — The name and address of the registrant or distributor is required on the label. The name and address should preferably be located at the bottom of the front panel or at the end of the label text. Item 3. NET CONTENTS - A net contents statement is required on all labels or on the container of the pesticide. The preferred location is the bottom of the front panel immediately above the company name and address, or at the end of the label text. The net contents must be expressed in the largest suitable unit, e.g., “1 pound 10 ounces” rather than “26 ounces.” In addition to English units, net contents may be expressed in metric units. See Appendix IV—l. [ 40 CFR 162 .10 (d)] Item 4 • EPA REGISTRATION NUMBER — The registration number assigned to the pesticide product must appear on the label, preceded by the phrase “EPA Registration No.,” or “EPA Reg. No.” The registration number must be set in type of a size and style similar to other print on that part of the label on which it appears and must run parallel to it. The registration number and the required identifying phrase must not appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency. See Appendix IV—l. [ 40 CFR 162.10(e)] Item 5. EPA ESTABLISHMENT NUMBER — The EPA establishment number, preceded by the phrase “EPA Est.” is the final estab— lishment at which the product was produced, and may appear in any suitable location on the label or immediate container. It must also appear on the wrapper or outside container of the package if the EPA establishment number on the immediate container cannot be clearly read through such wrapper or container. See Appendix IV—l. [ 40 CFR 162.10(f)] Item 6A. INGREDIENTS STATEMENT — An ingredients statement is required on the front panel. The ingredients statement must contain the name and percentage by weight of each active ingredient and the total percentage by weight of all inert ingredients. The preferred location is immediately below the product name. The ingredients statement must run parallel with, and be clearly distinguished from, other text on the panel. It must not be 35 ------- placed in the body of other text. See Appendix 1V—l. [ 40 CFR 162 .10 (g)) Item 6B. POUNDS PER GALLON STATEMENT — For liquid agricul- tural formulations, the pounds per gallon of active ingredient must be indicated on the label. Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS — Front panel precautionary statements must be grouped together, preferably within a block outline. The table below shows the minimum type size requirements for various size labels. Size of Label Signal Word “Keep Out of Reach on Front Panel Minimum Type Size of Children” in Square Inches All Capitals Minimum Type Size 5 and under 6 point 6 point above 5 to 10 10 point 6 point above 10 to 15 12 point 8 point above 15 to 30 14 point 10 point over 30 18 point 12 point Item 7A. CHILD HAZARD WARNING STATEMENT - The statement “Keep Out of Reach of Children” must be located on the front panel above the signal word except where contact with children during distribution or use is unlikely. See Appendix IV—1. [ 40 CFR162.lO(h)(1)(ii)] Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or CAUTION) is required on the front panel immediately below the child hazard warning statement. See Appendix IV—l. [ 40 CFR 162.10 (h)(l)(i)1 Item 7C. SKULL & CROSSBONES AND WORD “POISON” — On products assigned a toxicity Category I on the basis of oral, dermal, or inhalation toxicity, the word “Poison” shall appear on the label in red on a background of distinctly contrasting color and the skull and crossbones shall appear in immediate proximity to the word POISON. See Appendix IV—l. [ 40 CFR l62.lO(h)(l)(i)] Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of practical treatment (first aid or other) shall appear on the label of pesticide products in toxicity Categories I, [ I, and III. See Appendix IV—l. (40 CFR 162.l0(h)(l)(iii)1 Item 7E. REFERRAL STATEMENT — The statement “See Side (or Back) Panel for Additional Precautionary Statements” is required on the front panel for all products, unless all required precautionary statements appear on the front panel. See Appendix IV—l. [ 40 CFR l62.lO(h)(l)(iii)] 36 ------- iii. The flashpoint of the non—volatile liquid component is greater than 350°F (177°C). 3. Declaration of non—flammability . Products which meet the criteria for non—flammability specified above may bear the notation “non—flammable” or “non—flammable (gas, liquid, etc.)” on the label. It may appear as a substatement to the ingredients statement, or on a back or side panel, but shall not be highlighted or emphasized (as with an inordinately large type size) in any way that may detract from precaution. 4 . Other physical/chemical hazard statements . When chemistry data demonstrate hazards of a physical or chemical nature other than flammability, appropriate statements of hazard will be prescribed. Such statements may address hazards of explosivity, oxidizing or reducing capability, or mixing with other substances to produce toxic fumes. Item 9A . RESTRICTED USE CLASSIFICATION — FIFRA sec. 3(d) requires that all pesticide formulations/uses be classified for either general or restricted use. Products classified for restricted use may be limited to use by certified applicators or persons under their direct supervision (or may be subject to other restrictions that may be imposed by regulation). In the Registration Standard, the Agency has (1) indicated certain formulations/uses are to be restricted (Section I indicates why the product has been classified for restricted use); or (2) reserved any classification decision until appropriate data are submitted. The Regulatory Position and Rationale states whether products containing this active ingredient are classified for restricted use. If they are restricted the draft label(s) submitted to the Agency as part of your application must reflect this determination (see below). If you do not believe that your product should be classified for restricted use, you must submit any information and rationale with your application for reregistration. During the Agency’s review of your application, your proposed classi- fication determination will be evaluated in accordance with the provisions of 40 CFR 162.11(c). You will be notified of the Agency’s classification decision. Classification Labeling Requirements If your product has been classified for restricted use, the following label requirements apply: 1. Front panel statement of restricted use classification. 37 ------- Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING — The precautionary statements listed below must appear together on the label under the heading “PRECAUTIONARY STATEMENTS.” The preferred location is at the top of the side or back panel preceding the directions for use, and it is preferred that these statements be surrounded by a block outline. Each of the three hazard warning statements must be headed by the appropriate hazard title. See Appendix IV—l. (40 CFR 162.10 (h) (2)1 Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS — Where a hazard exists to humans or domestic animals, precautionary statements are required indicating the particular hazard, the route(s) of exposure and the precautions to be taken to avoid accident, injury or damage. See Appendix IV—l. [ 40 CFR 162.10 (h) (2) ( i) I Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non—target organisms excluding humans and domestic animals, precautionary statements are required stating the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage. See Appendix IV—1. [ 40 CFR 162 .10 (h) (2) (ii)] Item 8C. PHYSICAL OR CHEMICAL HAZARD 1. Flammability statement . Precautionary statements relating to flammability of a product are required to appear on the label if it meets the criteria in Appendix IV—3. The require- ment is based on the results of the flashpoint determinations and flame extension tests required to be submitted for all products. These statements are to be located in the side/back panel precautionary statements section, preceded by the heading “Physical/Chemical Hazards.” Note that no signal word is used in conjunction with the flammability statém nts. 2. Criteria for declaration of non—flammability . The following criteria will be used to determine if a product is non—flammable: a. A “non—flammable gas” is a gas (or mixture of gases) that will not ignite when a lighted match is placed against the open cylinder valve. b. A “non—flammable liquid” is one having a flashpoint greater than 350°F (177°C). C. A “non—flammable aerosol” is one which meets the following criteria: i. The flame extension is zero inches; ii. There is no flashback; and 38 ------- a. The statement “Restricted Use Pesticide” must appear at the top of the front panel of the label. The statement must be set in type of the same minimum size as required for human hazard signal word (see table in 40 CFR 162.1O(h)(1)(iv) b. Directly below this statement on the front panel, a summary statement of the terms of restriction must appear (including the reasons for restriction if specified in Section I). If use is restricted to certified applicators, the following statement is required: “For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for those uses covered by the Certified Applicator’s Certification.” 2. Some but not all uses restricted. If the Regulatory Position and Rationale states that some uses are classified for restricted use, and some are unclassified, several courses of action are available: a. You may label the product for Restricted use. If you do so, you may include on the label uses that are unrestricted, but you may not distinguish them on the label as being unrestricted. b. You may delete all restricted uses from your label and submit draft labeling bearing only unrestricted uses. c. You may “split” your registration, i.e., register two separate products with identical formulations, one bearing only unrestricted uses, and the other bearing restricted uses. To do so, submit two applications for reregistration, each containing all forms and necessary labels. Both applications should be submitted simul- taneously. Note that the products will be assigned separate registration numbers. Item 9C. MISUSE STATEMENT — All products must bear the misuse statement, “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.” This statement appears at the beginning of the directions for use, directly beneath the heading of that section. Item 1OA. REENTRY STATEMENT — If a reentry interval has been established by the Agency, it must be included on the label. Additional worker protection statements may be required in accordance with PR Notice 83—2, March 29, 1983. 39 ------- Item bC. STORAGE AND DISPOSAL BLOCK — All labels are required to bear storage and disposal statements. These statements are developed for specific containers, sizes, and chemical content. These instructions must be grouped and appear under the heading “Storage and Disposal” in the directions for use. This heading must be set in the same type sizes as required for the child hazard warning. Refer to Appendix IV—4, IV—5, and IV-6 to determine the storage and disposal instructions appropriate for your products. Item 1OD. DIRECTIONS FOR USE — Directions for use must be stated in terms which can be easily read and understood by the average person likely to use or to supervise the use of the pesticide. When followed, directions must be adequate to protect the public from fraud and from personal injury and to prevent unreasonable adverse effects on the environment. See Appendix P1—1. (40 CFR 162.10] B. Collateral Labeling Bulletins, leaflets, circulars, brochures, data sheets, flyers, or other written or graphic printed matter which is referred to on the label or which is to accompany the product are termed collateral labeling. Such labeling may not bear claims or representations that differ in substance from those accepted in connection with registration of the product. It should be made part of the response to this notice and submitted for review. 40 ------- VI. INSTRUCTIONS FOR SUBMISSION A. For Manufacturing Products (MP) containing Thiophanate ethyl as sole active ingredient . 1. Within 90 days from receipt of this document, you must submit to the Product Manager in the Registration Division at the address given at the end of this section the “FIFRA Section 3(c)(2)(B) Summary Sheet” EPA Form 8580—1. Refer to Appendix 11—3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within 6 months from receipt of this document you must submit to the Product Manager on the Registration Division: a. Confidential Statement of Formula, EPA Form 8570—4. b. Product Specific Data Report, EPA Form 8580—4 (Appendix 111—1). C. Two copies of any required product—specific data (See Tables B). d. Two copies of draft labeling, including the label and associated brochures. If current labeling conforms to the requirements of this guidance document and the results of the short—term data, you may submit such labeling. End use product labeling must comply specifically with the instructions in Section I (Regulatory Position and Rationale) of this guidance document. The labeling should be either typewritten text on 8—1/2 x 11 inch paper or a mockup of the labeling suitable for storage in 8—1/2 x 11 inch files. The draft label must indicate the intended colors of the final label, clear indication of the front panel label, and the intended type sizes of the text. e. Evidence of compliance with data support requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80—152.99 for latest requirements. 3. Within the times set forth in Table A , you must submit to the Registration Division all generic data, •unless you are eligible for the formulator’s exemption. If for any reason any test is delayed or aborted so that the agreed schedule cannot be 41 ------- met, notify the Product Manager and the Office of Compliance Monitoring. B. For Manufacturing use Products containing Thiophanate ethyl in combination with other active ingredients 1 . Within 90 days from receipt of this document, you must submit the 11 FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form 8580—1. Refer to Appendix 11—3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within the times set forth in Table A , you must submit to the Registration Division all generic data, unless you are eligible for the formulator’s exemption. If for any reason any test is delayed or aborted so that the agreed schedule cannot be met, notify the Product Manager and the Office of Compliance Monitoring. C. For End Use Products containing Thio hanate ethyl alone or in combination with other active ingredients : 1. Within 90 days from receipt of this document, you must submit the “FIFRA Section 3(c)(2)(B) Summary Sheet,” EPA Form 8580—1 . Refer to Appendix 11—3 with appropriate attachments. If on the Summary Sheet, you commit to develop the data, request a minor chemical exemption, present arguments that a data requirement is not applicable, or submit protocols or modified protocols for Agency review, you must also submit a copy of the Summary Sheet (and any supporting information) to the Office of Compliance Monitoring, which will be monitoring the data generated in response to this notice. This information should be submitted to the Office of Compliance Monitoring at the address given at the end of this section. (Actual studies are not to be submitted.) 2. Within 6 months from receipt of this document you must submit: a. Confidential Statement of Formula, EPA Form 8570—4. b. Product—Specific Data Report, EPA Form 8580—4 (Appendix 111—1), if applicable (if Table C lists required product—specific data). 42 ------- c. Two copies of any required product-specific data, if applicable (if Table C lists required product—specific data). d. Two copies of draft labeling, including the label and associated brochures. If current labeling conforms to the requirements of this guidance document and the results of the short—term data, you may submit such labeling. End use product labeling must comply specifically with the instructions in Section I (Regulatory Position and Rationale) of this guidance document. Labeling should be either typewritten text on 8 1/2 x 11 inch paper or a mockup of the labeling suitable for storage in 8 1/2 inch files. The draft label must indicate the intended colors of the final label, clear indication of the front panel label, and the intended type sizes of the text. 3. Within the time frames set forth in Table A , submit all generic data, unless you are eligible for the formulator’s exemption. D. For intrastate products containing Thiophartate ethyl either as the sole active ingredient or in combination with other active ingredients These products are being called in for full Federal registration. Producers of these products are being sent a letter instructing them how to submit an application for registration. E. Addresses Applications and other required information should be submitted to the following address: Product Manager 21 Registration Division (TS—767C) Office of Pesticide Programs Environmental Protection Agency 401 M St., SW. Washington, D.C. 20460 Phone o. (703) The address for submission to the Office of Compliance Monitoring is: Laboratory Data Integrity Program Office of Compliance Monitoring (EN—342) Environmental Protection Agency 401 NI St., SW. Washington, D.C. 20460 43 ------- Appendix 11—1 Guide to Use of This Bibliography 1. CONTENT OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Standard. Primary sources for studies in this bibliography have been the body of data submitted to 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, will be included. 2. 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 attempted ‘also to unite basic documents and commentaries upon them, treating them as a single study. 3. 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 at any time 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 a further explana- tion. In a few cases, entries added to the bibliography late in the review may be preceded by a nine—character temporary identifier. These entries are listed after all MRID entries. This temporary identifier number is also to be used whenever specific reference is needed. 4 . 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 standards of the American National Standards Institute (ANSI), expanded to provide for certain special needs. 44 ------- Appendix 11—1 (continued) a. Author. Whenever the Agency could confidently identify one, 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 author. As a last resort, the Agency has shown the first submitter as author. b. Document Date. When the date appears as four digits with no question marks, the Agency took it directly from the document. When a four—digit date is followed by a question mark, the bibliographer deduced the date from evidence in the document. When the date appears as (19??), the Agency was unable to determine or estimate the date of the document. C. Title. In some cases, it has been necessary for 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 fol- lowing 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, following the phrase “submitted by.” When authorship is defaulted to the submitter, this element is omitted. (4) Volume Identification (Accession Numbers). The final element in 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,” standing 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. For example, within accession number 123456, the first study would be 123456—A; the second, 123456— B; the 26th, l23456—Z; and the 27th, 123456—AA. 45 ------- APPENDIX 11—2 OFFICE OF PESTICIDE P XRAMS R ISTRATION STANDARD BIBLIO3RkPHY Citations Considered to be Part of the Data Base Supporting Registration Under the Standard For Thiophanate Ethyl MRID Citation 00032673 Noguchi, T.; Mashincto, Y.; Makita, T.; et al. (1971) Chronic Oral Tbxicity Studies of Thiophanate, Diethyl 4,4’—O—phenylene bis 3—thioallophanate in Sprague—Dawley Strain Rats. (Unpublished study received Jun 27, 1980 under 4581—336; prepared by Nippon Soda Co., Ltd. in cooperation with Nara Medical Univ., Second Dept. of Pathology, submitted by Penriwalt Corp., Agchem Div., King of Prussia, Pa.; CDL:242740—B) 00032674 Fiashinoto, Y.; Makita, T.; Nishibe, T.; et al. (1972) i xico1ogical Evaluation of Thiophanate (X): The Final Report on the Carcino- genesis Studies of Thiophanate, Diethyl 4,4’-o-phenylenebis (3— thioallc’phanate), in Mice of C57BL Strain for Full Life Span. (Unpublished study received Jun 27, 1980 under 4581—336; pre- pared by Nippon Soda Co., Ltd. in cooperation with Nara Medical Univ., Second Dept. of Pathology, submitted by Pennwalt Corp., Agchem Div., King of Prussia, Pa.; CDL:242740—C) 00050517 Shellenberger, T.E. (1971) Letter sent to Paul Sartoretto dated Mar 4, 1971: An acute toxicological evaluation of Cleary 3336 fungicide with adult mallard ducks. (Unpublished study received Mar 4, 1971 under unknown admin. no.; prepared by Gulf Soith Research Institute, submitted by W.A. Cleary Corp., Sonerset, N.J.; CDL:104612—B) 00068776 Pennwalt Corporation (19??) Product Chemistry—Data Requirenents: [ Thiophariatel. (Unpublished study received Mar 3, 1978 under 4581—336; CDL:233302—A) 00079196 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Eight—day Dietary LC50——Bob zhite Quail: Project 1 }z. 110—125. (Unpublished study, including letter dated Mar 20, 1981 fran A.O. Landskov to Bernalyn M 3aughey, received Jun 10, 1981 under 4581—336; prepared by Wildlife International, Ltd. and Washing- ton College, submitted by Pennwalt Corp., Philadelphia, Pa.; CDL:24 5301—C) 00079197 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Eight—day Dietary LC5O——Mallard t ick: Project sb. 110—126. (Un- published study received Jun 10, 1981 under458l—336; prepared by Wildlife International, Ltd. and Washington College, submit- ted by Pennwalt Corp., Philadelphia, Pa.; CDL:245301—D) 46 ------- APPENDD( 11—2 OFFICE OF PESTICIDE PI XPAt4S R ISTRATION STANDARD BIBLICXRAPHY Citations Considered to be Part of the Data Base Supporting Registration Under the Standard For Thiophanate Ethyl MRID Citation 00079198 LeBlanc, GA.; Sousa, J.V. (1981) Acute Toxicity of Topsin E Fungi- cide to Rainbo. , Trait (Saln gairdrieri): Report *BW-81—3— 843. (Unpublished study, including letter dated Apr 9, 1981 frau A.O. Landskov to Bernalyn McGaughey, received Jun 1981 under 4581—336; prepared by EG & G, Bionamics, submitted by Pennwalt Corp., Philadelphia, Pa.; CDL:245301—E) 00079199 LeBlanc, G.A.; Sousa, J.V. (1981) Acute Toxicity of Topsin E Fungi- cide to Bluegill (L.epom.is rnacrochi us): Report BW-81—2—835. (Unpublished study, including letter dated Apr 9, 1981 fran A.O. Landskov to Bernalyn McGaughey, received Jun 10, 1981 under 4581—336; prepared by EG & G, Bionauics, submitted by Pennwalt Corp., Philadelphia, Pa.; CDL:245301—F) 00079200 LeBlanc, G.A.; Surprenant, D.C. (1981) Acute Toxicity of Topsin E Fungicide to the Water Flea (Daphnia magna): Report #BW-81— 2—814. (Unpublished study, including letter dated May 21, 1981 fran A.O. L.anskov to Bernalyn M 3aughey, received Jun 10, 1981 under 4581—336; prepared by EG & G, Bioncmics, submitted by Pennwalt Corp., Philadelphia, Pa.; CDL:245301—G) 00085643 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Acute Oral Lr50—Bob Jhite Quail: Project b. 110—127. (Unpub- lished study, including letter dated Mar 20, 1981 fran A.O. Landskov to Bernalyn McGaughey, received Jun 10, 1981 under 4581—336; prepared by Wildlife International, Ltd. and Washing- ton College, submitted by Pennwalt Corp., Philadelphia, Pa.; CDL: 24 530 1—B) 00088444 Pennwalt Corporation (19??) Chemical and Physical Properties of Topsirt E and Topsin M. (Unpublished study, including letter dated Dec 8, 1971 fran R.E. Carlson to J.L. Sandeno, received Feb 9, 1973 under 4581—288; CDL:007463—A) 00089068 Pennwalt Corporation (19??) Introduction: [ Topsin and Topsin M). (Unpublished study received Jan 12, 1971 under 4581—278; CDL: 007453—A) 00089070 Hashinoto, Y.; rlakita, T.; Mori, T.; et al. (1970) Toxicological evaluations of thiophanate: (I) Acute and subacute toxicity of a new fungicide, thiophanate (active ingredient of NF—35), 1,2— bis—(ethoxy carbonyl—thioureido)—benzene. Pharmacometrics 4 (1): 5—21. (Also in unpublished submission received Jan 12, 1971 under 4581—278; submitted by Pennwalt Corp., Philadelphia, Pa.; CDL :00 74 53—D) 47 ------- APPENDIX 11—2 OFFICE OF PESTICIDE Pl X3RAMS R ISTRATION STANDARD BIBLI RAPHY Citations Considered to be Part of the Data Base Supporting Registration Under the Standard For Thiophanate Ethyl MRID Citation 00098045 Collins, C.J.; Breckeriridge, C.; Broxup, B.; et al. (1981) The Acute Toxicity of Inhaled Topsin E Technical in the Albino Rat: Project b. 81197. (Unpublished study received Apr 1, 1982 under 4581—336; prepared by Bio—Research Laboratories Ltd., Canada, subrtitted by Pennwalt Corp, Philadelphia, Pa.; CDL: 2471 28—A) 00098046 Bier, C,B.; Bran ell, S.; Procter, B.G. (1981) Primary Eye Irri- tation Study in Albino Rabbits Administered Test Article Top- sin (R) E Technical: Project 50110. (Unpublished study re- ceived Apr 1, 1982 under 4581—336; prepared by Bio-Research Laboratories Ltd., Canada, su nitted by Pennwalt Corp., Phila- delphia, Pa.; CDL:247128—B) 00098047 Bier, C.B.; Reuben, 4.A.; Procter, B.G. (1981) Primary Dermal Irritation Study in Albino Rabbits Administered Test Article T sin (R) E Technical: Project . 50111. (Unpublished study received Apr 1, 1982 under 4581—336; prepared by Bio-Research Laboratories Ltd., Canada, su uitted by Pennwalt Corp., Phila- delphia, Pa.; CDL:247128—C) 48 ------- O7.—O 57 (E .t r- _.13 /SE ) •P REGISTRATION NO FIFRA SECTION 3(C)(2)(b) SUMMARY SHEET PRODUCT NAME APPLICANT’S NAME DATE GUIDANCE DOCUMENT ISSUED With respect to the requirement to submit “generic” data imposed by the FIFRA section 3(C)(2)(B) notice contained in tne referenced Guidance Document. I am responding in the following manner U 1. I will submit data in a timely manner to setisfy the following requirements. If the test procedures I will use deviate tram (or are not specified in) the Registration Guidelines or the Protocols contained in the Reports of Exoert Groups to me Chemicals Group, DECO Chemicals Testing Programme, I enclose the protocols that I will use 02. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data requirements. The tests, and any required protocols, will be submitted to EPA by. NAME OF OTHER REGISTRANT 03. I enclose a completed “Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data” with respect to the following data requirements: 04. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products): 0 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.) REGISTRANT’S AUTHOR IZED REPRESENTATIVE SIGNATURE DATE EPA Form 85801 (1082) ------- 0MB Approval 2070—0057 (expires 5/31/86) GUIDANCE DOCUMENT DATE ACTIVE INGREDIENT EPA COMPANY NUMBER CERTIFICATION OF ATTEMPT TO ENTER INTO AN AGREEMENT WITH OTHER REGISTRANTS (To qualify, ce rify Jj four items) FOR DEVELOPMENT OF DATA (This firm or group of firms is referred to below as “my firm”.) 2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required items or data: 1. I am duly authorized to represent the following firm(s) w ho are subject to the require- ments of a to submit d Notice under ata concernin FIFRA Section 3(c)(2)(B) contained in a Guida g the active ingredient nce Document NAME OF FIRM 3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. Thus offer was made to the following firm(s) on the following date(s)’ NAME OF FIRM DATE OF OFFER However, none of those firm(s) accepted my offer. 4 My firm requests that EPA not suspend the registration(s) of my firm’s product(s). if any of the firms named in paragraph (3) above have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA wilt promptly inform me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request. TYPEDNAME SIGNATURE OATE I mn r. .. tO4 ------- Appendix 111—1 PRODUCT SPECIFIC DP TA REPOR1’ EPA Registration o. Guidance Document for_________ Date 1 Registration Guideline t .b. Name of Test Test not required for my product listed above (check belc ) I am complying with data requirements by (For EPA Use Only) Accession Numbers Assigned Citing MRID Suthüt— ting Data (At— tached) § 158 .20 PRODUCT CHEMISTRY ___________ 61—1 Identity of ingredients 61—2 Staten nt of caiipos it ion 61—3 Discussion of formation of ingredients 62—1 Preliminary analysis 62—2 Certification of 1 irnits 62—3 Analytical rt thods for enforcert nt 1 imits 63—2 Color 63—3 Physical state 63—4 Odor __________ 63—5 Melting point 63—6 Boiling point 63—7 Density, kxilk— density, or specific_gravity 63—8 Solubility 63—9 Vapor pressure 63—ID Dissociation constant 63—11 Octariol/water part it ion coefficient 63—12 pH 51 ------- Appendix 111—1 (continued) Registration Guideline b. Name of Test Test not required for my product listed above (check bel ) I am complying with data requirements (For EPA Use Only) Accession Nuxtters Assigned Citing MRID# Sut nit— ting Data (At— tached) 63—13 Stability 63—14 Oxidizing/reducing react ion 63—15 Flair nability 63—16 E lodability 63—17 Storage stability 63—18 Viscosity 63—19 Miscibility 63—20 Corrosion characteristics 63—21 Dielectric break— d in voltage §158.135 it ucoux 81-1 Acute oral LD-50, rat 81—2 Acute dermal ED-SO 81—3 Acute inhalation, LC—5O_rat 81-4 Primary eye irritation, rabbit 81—5 Primary dermal irritation 81—6 Dermal sensitiza- tion [ _______ 52 ------- uuii& Lor shall den &n application reviewed under p aragrap (d) of this section if any of the requiz-em of paragraph (d)(2) of this section are not met, or if there are insufficient data to make the required determina- tions. (fl Not ification. Promptly after making a determination to deny a reg. istration, the Administrator shall notify the applicant by certified letter of the denial of registration and shall set forth the reasons and factual basis for the determination and the condi. tions, if any, which must be satisfied in order for the registration to be ap• proved, (2) Opportunity for remedy by app! I- cant. (I) The applicant will have 30 days from the date of receipt of the certified letter to take the specified Corrective action. (ii) The applicant may petition the N’) Administrator to Withdraw his applica- In tion. The Adminstrator may, in his discretion deny any petition for with- drawal and proceed to issue a notice of denial in accordance with paragraph (f)(3) of this section, (3) FEDEL L REGISTER publication jf the applicant fails to remedy the defi- ciency of his registration application. the Administrator shall promptly issue In the Fm m j REGISTER a notice of denial of registration Such notice shall set forth the reasons and factual basis for the denial and shall contain the name and address of the applicant, the product flame, the name and per. ceritage by weight of each active ingre- dient in the product, the proposed pat- terns of use, and the proposed classifi- cation. (4) Rearing rights. Within 30 days following publication of the denial In the FEDERAL REGISTER, the applicant or any interested party with the written authorization of the applicant may re- quest a hearing pursuant to section 6(b) of the Act and Part 164 of these regulatio It no hearing is timely re- quested. the denial shall become effec- ttve at the end of the 30 days. (g) DZ3pO itt fl of matenal submit- ted with the application The test data and other information submitted with an application shall become a part of the official file of the Agency for that. 92 auon. . :p( provided by section 10 of the Aa within 30 days after the registratfofl a pesticide, the data called for in lb registration statement together altI such other scientific information the Administrator deems relevant k his decision shall be made availa for public inspection. (48 FR 34004, July 26. 1983) 0 162.8 Data to be furnished by appiIe (a) An applicant for regis ra o registration, or amendment of a regl tration Under FIFRA sec. 3(c)(5) shal furnish data as required by thi Agency to determine whether his a plication may be approved under thh Part. (b) An applicant shall submit with his application any factual informi tion regarding adverse effect.s of lb pesticide on the environment or mas that. (I) Hg been obtained by him orha& come to his attention; and (2) Insofar as he is aware, has n previously been submitted to lb Agency. Such information shall include, bui shall not be limited to, published ot Unpublished laboratory studies and as cident experience. [ 48 FR 34005. July 26, 19831 0 162.10 LabelIng requirements (a) Generaj—(1) Contents of the label, Every pesticide products shall bear a label containing the informs tion specified by the Act and the regu lations in this Part. The contents of a label must show clearly and prorni nently the following- (i) The name, brand, or trademark under which the product is sold as pre scribed in paragraph (b) of this sec Lion; (ii) The name and address of the producer registrant, or person for whom produced as prescribed in para graph (C) of this section; (lii) Th net contents as prescribed in paragraph (d) of this section; (iv) The product registration number as prescribed in paragraph (e) of this section; r) Th producing edblishment cumber as prescribed in paragraph (f) ci this section; i An ingredient statement as pre- Kilbed in paragraph ( ) of this sec- 1 lion; (iii) Warning or precautionary state- enLs as prescribed In paragraph (h) ol this section; (viii) The directions for use as pre- ibed in paragraph (I) of this section; and (lx) The use classification(s) as pre- rlbed in paragraph (J) of this section. (2) PromInence and legibility. (I) All voids, statements, graphic representa- lions, designs or other information re- quired on the labeling by the Act or the regulations In this part must be clearly legible to a person with normal vision, and must be placed with such conspicuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to be read and understood by the ordinary individual under custom- ary conditions of purchase and use. Iii) All required label text must: (A) Be set in 6-point or larger type; (B) Appear on a clear contrasting background; and (C) Not be obscured or crowded, (3) Language to be used. All required label or labeling text shall appear In the English language. However, the Agency may require or the applicant may propose additional text in other languages as is considered necessary to protect the public. When additional text in another language is necessary. all labeling requirements will be ap- plied equally to both the English and other-language versions of the label- ing (4) Placement of Label—(i) General, The label shall appear on or be secure- ly attached to the immediate contain- er of the pesticide product. For pur- poses of this Section, and the mis- branding provisions of the Act, “se- curely attached” shall mean that a iabel can reasonably be expected to remain affixed during the foreseeable conditions and period of use. If the im- mediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely at- L.fled to such OU.4de wrapper or ..on- tamer, if it is a part of the package as customarily distributed or sold. ( II) Tank cars and outer bulk con-S talners—(A) Transportation. While a pesticide product is in transit, the ap- propriate provisions of 49 CFR Parts 170-189, concerning the transportation of hazardous materials, and specifical- ly those provisions concerning the la- beling, marking and placarding of haz- ardous materials and the vehicles car- rying them, define the basic Federal requirements. In addition, when any registered pesticide product is trans- ported in a tank car, tank truck or other mobile or portable bulk contain- er, a copy of the accepted label must be attached to the shipping papers, and left with the consignee at the time of delivery. (B) Storage. When pesticide prod- ucts are stored in bulk containers, whether mobile or stationary, which remain in the custody of the user, a copy of the label of labeling, including all appropriate directions for use, shall be securely attached to the container in the immediate vicinity of the dis- charge control valve. - (5) False or misleading statements. Pursuant to section 2(q)( IXA) of the Act, a pesticide or a device declared subject to the Act pursuant to * 162.15, is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pea- ticidal claims. Examples of statements or representations in the labeling which constitute misbranding include: (I) A false or misleading statement concerning the composition of the product; (ii) A false or misleading statement concerning the effectiveness of the product as a pesticide or device; (iii) A false or misleading statement about the value of the product for purposes other than as a pesticide or device; (lv) A false or misleading comparison with other pesticides or devices; (v) Any statement directly or indi- rectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Govern- ment; (vi) The name of a pesticide which contains two or more principal active 93 ------- § 162.10 ingredients it the name suggests one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling: (vii) A true statement used in such a way as to give a false or misleading Im- pression to the purchaser; (viii) Label disclaimers which negate or detract from labeling statements re- quired under the Act and these regula- tions; Li ç) Claims as to the safety of the pesticide or its ingredients, in ludlng statements such as “safe.” “nonpoison- ous.” “noniniurlous,” “harmless” or “nontoxic to humans and pets” with or without such a qualifying phrase as “when uzed as directed”; and (x) Non-numerical and/or compara- tive statements on the safety of the product, including but not limited to: (A) “Contains all natural Ingredi- ents”; (B) “Az ong the least toxic chemi- cals known” (C) “Pollution approved” (6) FInal printed labeling. (I) Except as provided In paragraph (a)(OXII) of this section, final printed labeling must be submitted and accepted prior tq . 5 registratlon. However, final printed ‘ iSeUng need not be submitted until att label texts have been provision- ally accepted by the Agency. (ii) Clearly legible reproductions or photo reductions will be accepted for unusual labels such as those silk- screened directly onto glass or metal containers or large bag or drum labels. Such reproductions must be of micro- film reproduction quality. (b) Name, brand, or trademark (1) The name, brand, or trademark under which the pesticide product is sold shall appear on the front panel of the label. (2) No name, brand, or trademark may appear on the label which: (1) Is false or misleading, or (ii) Baa not been approved by the Administrator through registration or supplemental registration as an addi- tional name pursuant to 182.8(b)(4). (c) Name and address of producer, registrant, or person for whom pro- duced. An unqualified name and ad- dress given on the label shall be con- sidered as the name and addres of the 40 CFR Ch. I (7-1-85 EditIon) producer. If the registrant’s name ap pears on the label and the registrant Is not the producer, or If the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as “Packed for ‘ ‘ ,“ “Distribut edby’ • ,“or”Soldby “toshow that the name is not that of the pro- ducer. (d) Net weight or measure of con tents. (1) The net weight or measure of content shall be exclusive of wrap pers or other materials and shall be the average content unless explicltb stated as a minimum quantity. (2) If the pesticide Is a liquid, the net content statement shall be in terms of liquid measure at 68’ F (20’Cl and shall be expressed in conventional American units of fluid ounces, pint-i. quarts, and gallons. (3) If the pesticide Is solid or semi- solid, viscous or pressurized, or Is $ mixture of liquid and solid, the net content statement shall be in terms ol weight expressed as avoirdupob pounds and ounces. (4) In all cases, net content shall bi stated In terms of the largest suitable units, i.e.. “1 pound 10 ounces” rathee than “28 ounces.” (5) In addition to the required uniti specified, net content may be ex pressed in metric units. (8) Variation above minimum con tent or around an average is permissi- ble only to the extent that It repre senta deviation unavoidable in good manufacturing practice. Varlatlot below a stated minimum Is not permit ted. In no case shall the average cos tent of the packages in a shipment fit below the stated average content. (e) Product registration numbc’ The registration number assigned ii the pesticide product at the time d registration shall appear on the Jabd preceded by the phrase “EPA Regla tration No.,” or the phrase “EPA Rt No.” The registration number shaU bi set In type of a size and style simllatv other print on that part of the labs on which It appears and shall run psi allel to It. The registration numbe and the required Identifying phru - shall not appear in such a manner to suggest or Imply recommendatl Environmental Protection Agency or endorsement of the product by the ‘tgency. if) Producing establishments regis- tration number. The producing estab- lishment seglstratiogi number preced- ed by the phrase “EPA Est.”, of the final establishment at which the prod- uct was produced may appear In any suitable location on the label or tninie- diate container. It must appear on the a ’rapper or outside container of the package if the EPA establishment reg- istration number on the immediate container cannot be clearly read through such wrapper or container. (g) Ingredient statement—(1) Gener- aL The label of each pesticide product must bear a statement which contains the name and percentage by weight of each active ingredient, the total per- centage by weight of all inert ingredi- eats, and if the pesticide contains ar- lenic in any form, a statement of the rcentages of total and water-soluble usenic calculated as elemental ar- senic. The active ingredients must be 4esignated by the term “active Ingredi- ails’ and the inert Ingredients by the term “inert ingredients,” or the singu- ke forms of these terms when appro- Pilate Both terms shall be in the wine type size, be aligned to the same n&rgln and be equally prominent. The Ic.atement “Inert. Ingredien(s, none” Is • required for pesticides which con- slis 100 percent active ingredients. L’nless the Ingredient statement is a axaplete analysis of the pesticide, the erm “analysis” shall not be used as a z adIng for the ingredient. stktemerit. Ill Position of Ingred ient statement. A The ingredient statement is nor- asily required on the front panel of t e label If there Is an outside con- a,. ’er or wrapper through which the eijred tent. statement cannot be clearly a .1, the Ingredient statement must so appear on such outside container ii %rapper. If the size or form of the 3a.tsge makes it impracticable to 315ce the ingredient statement on the ot panel of the label, permission aaj be granted for the ingredient g.susnent to appear elsewhere. .ai The text of the ingredient state- aidnt must run parallel with other is on the panel on which it appears, aiw must. be clearly distinguishable § 162.10 from and must not be placed in the body of other text, (3) Names to be used In Ingredient statement. The name used for each in- gredient shall be the accepted con)mon name, if there is one, fol- lowed by the chemical name. The common name may be used alone only If It is well known, If no common name has been established, the chemical name alone shall be used. In no case will the use of a trademark or proprie- tary name be permitted unless such name has been accept-ed as a common name by the Administrator under the authority of Section 25(c)(8), (4) Statementj of percentages. The percentages of ingredients shall be stated In terms of weight-to-weight, The sum of percentages of the active and the inert Ingredients shall be 100. Percentages shall not be expressed by a range of values such as “22-25%.” If the uses of the pesticide product are expressed as weight of active ingredi- ent per unit area, a statement- of the weight of active Ingredient per unit volume of the pesticide formulation shall also appear In the ingredient statement, (5) Accurac j of stated percentages. The percentages given shall be as pre- cise as possible reflecting good manu- facturing practice. If there may be un- avoidable variation between manufac- turing batches, the value stated for each active ingredient shall be the lowest percentage which may be present. (8) Deterioration, Pesticides which change in chemical composition sig- nificantly must meet the following la- beling requirements: (I) In cases where it is determined that a pesticide formulation changes chemical composition significantly, the product must bear the following statement in a prominent position on the label: “Not for sale or use after (date).” (ii) The product must meet all label claims up to the expiration time indi- cated on the label. (1) Inert ingredients, The Adminis- trator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredlent(r,) may pose a hazard to man or the environm”-’t, ------- 40 CFR Ch. I (7-1-85 EditIon) Environmental Protection Agency § 162.10 (h) Warnings and precautionary statements. Required warnings and precautionary statements concerning the general areas of toxicological hazard including hazard to children. environmental hazard, and physical or chemical hazard fall into two groups; those required on the front panel of the labeling and those which may appear elsewhere. Specific require- ments concerning content, placement, Ci) Human hazard signal word—(A) Ti city Category I. All pesticide prod. ucta meeting the criteria of Toxicity Category I shall bear on the front panel the signal word “Danger.” In ad- diUon if the product was assigned to Toxicity Category I on the basis of its &al, inhalatiop or dermal toxicity (as stI,nct from akin and eye local ef- fects) the word ‘Poison” shall appear in red on a background of distinctly contrasting color and the skull and crossbones shall appear in immediate proximity to the wot’d “poison.” (B) Toxicity Category II. All pesti- cide products meeting the criteria of Toxicity Category II shall bear on the front panel the signal word “Warn- ing.” (C) Toxicity Category III. All pesti- cide products meeting the criteria of Toxicity Category Ill shall bear on the front panel the signal word “Cau- tion.” (D) Toxicity Category IV, All pesti- cide products meeting the criteria of Toxicity Category IV shall bear on the front panel the signal word “Caution.” (E) Use of signal words. Use of any signal word(s) associated with a higher Toxicity Category is not permitted except when the Agency determines type size, and prominence are given below. (1) Required front panel statement& With the exception of the chili hazard warning statement, the text.re quired on the front panel of the label Is determined by the Toxicity Catego ry of the pesticide. The category is a signed on the basis of the highes hazard shown by any of the indicaton in the table below. that such labeling is necessary to pie vent unreasonable adverse effects a man or the environment. In no cu shall more than one human hazul signal word appear on the front pa of a label. (ii) Child hazard warning. Every pa ticide product label shall bear on tki front panel the statement “keep outs reach of children.” Only In ca where the likelihood of contact wtu children during distribution, mark5 tog, storage or use is demonstrated t the applicant to be extremely renida or If the nature of the pesticide lsstd that it is approved for use on infam or small children, may the Adminiuui tor waive this requirement. (lii) Statement of practical trr ment—(A) Toxicity Category I I statement of practical treatment (fis aid or other) shall appear on the fr panel of the label of all pesticides hi ing into Toxicity Category I on l basis of oral, Inhalation or dermal I Icity. The Agency may, howe c permit reasonable variations in placement of the statement of prig cal treatment is some reference as “See statement of practical lx rnent on back panel” appears on front panel near the word “Poison” and the skull and crossbones, (B) Other toxicity categories. The statement of practical treatment is not required on the front panel except as described In paragraph (h)(l)(iIl)(A) of this section. The applicant may, how- ever, include such a front panel state- ment at his option. Statements of practical treatment are, however, re- quired elsewhere on the label in accord with paragraph (h)(2) of this section If they do not appear on the front panel. (iv) Placement and prominence. All the require front panel warning state- ments shall be grouped together on the label, and shall appear with suffi- dent prominence relative to other front panel text, and graphic material to make them unlikely to be over- oked under customary conditions of pirchase and use. The following table shows the minimum type size require- aent .s for the front panel warning u ,stements on various sizes of labels: S Environmengaj hazards. Where a awd exists to non target organisms usluding humans and domestic ani- aa. s.. precautionary statements are re- stating the nature of the § 16210 Size of label trool panel Si S4 iWI RO JVOd I “Keep out 0 5andunder - .. AbovuSt olO . .. AbOve l OtoIS . ... Abovel5toll0 . . Over3O , 6 tO 12 14 53 6 6 6 10 12 (2) OCher required warnings and pre- cautionary statements. The warnings and precautionary statements as re- quired below shall appear together on the label under the general heading “Precautionary Statements” and under appropriate subheadIngs of ‘Hazard to Humans and Domestic Ani- mals,” “Environmental Hazard” and “Physical or Chemical Hazard.” U) Hazard to humans and domestic animals. (A) Where a hazard exists to humans or domestic animals, precau- tionary statements are required indi- cating the particular hazard, the route(s) of exposure and the precau- tions to be taken to avoid accident, injury or damage. The precautionary paragraph shall be immediately pre- ceded by the appropriate hazard signal word. (B) The following table depicts typi- cal precautionary statements, These statements must be modified or ex- panded to reflect specific hazards. hazard and the appropriate precau- tions to avoid potential accident. injury or damage. Examples of the hazard statements and the circum- Hazard Sidicetars Toxicity categories I II Ill I v Oral ID ,, . ,. Inhalation LC,, Up (0 and Vicb,jduig 50 mg/kg. Up to and h- ,ckirkng 2 mg/ tier From 50 lIeu 500 mg/k9 From 2 1 1ev 2 mg/tiles From 500 5ev 5000 mg/ kg - From 2 thu 20 mg/titer 20,000 Greator than 5000 mg kg Greater then 29 mg/b Greater than 20,000 DerTrrai ID.. Up to and Wicluding 200 mg/kg. From 200 lIeu 2000 corned opadty No Irr Itation Eye effects ConOsIeo. corned opacity not severable s4thn 7 days. Corneel opacity reversible withIn 7 days. Siltation persisting far 7 days IrritatIon reversible wIthin 7 days Irritation 72 Mdd or slight Irilibel Skin eflects Co rro& ire_ ,,... Severe Vitiation at 72 harts hours 72 hours S ! _ by toxicity category Oral inhalation, or derinal losicity . and aye local etlects .. Fatal (poisonous) d swallowed (inhaled or absorbed through akin) Do not breathe vapor (dust or spray mist] Do not got In eyes on skin, or on clothing (Front panel statument of practical treatment re. qilired May be fatal IS sweflowed (inflated or absorbed though tho skin) Do riot breathe vapors (dust or spray mist) Do not gel in ayes, on skin, or on clothing (Appropriate Iest aid Statements required I Haimlul IS swallowed (inflated or absorbed through the she) Avoid breathing vapors (dust or spray mist) Avoid contact with skin (eyes or Clothing) (Appro- pilate first aid statement roqutred) (No precautionary statornents required I Corrovvo. causes eye and skin damage (or skin &rntahori) Do not gel Vi 6105. On SkI II, or on clothing Wow goggles or lace shield and rubber gloves when handling harmful or fatal Ii swallowed (Appropriate first aid statement required) Causes eye (arid Skin) Irritation Do not gel Vi eyes, on skin, or on clothing Harmful IS swallowed lAp- propriate tlrsl aid statement required I Avoid coniacl with skin, eyes or clothing In case of contact Immediately flush eyes or skin with plenty of water Get medical attention if k’jitadon persists (No precautionary Statements requIred I I OR ------- 40 CFR Ch. 1(7.1-85 EditIon) Environmental Protection Agency § 162.10 § 162.10 stances under which they are required follow: (A) If a pesticide intended for out- door use contains an active ingredient with a mammalian acute oral LDw of 100 or less, the statement “This Pesti- cide Is Toxic to Wildlife” is required. (B) If a pesticide intended for out- door use contains an active ingredient with a fish acute LC,. of 1 ppm or less. the statement “This Pesticide is Toxic to Fish” Is required. (C) If a pesticide Intended for out- door use co talna an active Ingredient with an avian acute oral L I D , 0 of 100 mg/kg or less, or a subacute dietary LC . of 500 ppm or less, the statement “This Pesticide is Toxic to Wildlife” is required. (D) It either accident history or field studies demonstrate that use of the er below 20’ 1 - bOv. 20’ F end not over 80’ F, ‘ Ahoy. 80’ F and ret over 150 F (i) Directions for Use—(1) General requ lrements—(i) Adequacy and cZar- lti, of di recUons. Directions for use must be stated in terms which can be easily read and understood by the av- erage person likely to use or to super- vise the use of the pesticide. When fol- lowed, directions must be adequate to protect the public from fraud and from personal injury and to prevent unreasonable adverse effects on the environment. (ii) Placement of directions for use. pirections may appear on any portion of the label provided that they are conspicuouS enough to be easily read by the user of the pesticide product. irections for -‘se may appear on pesticide may result in fatality to birds, fish or mammals, the statement “This pesticide is extremely toxic to wildlife (fish)” is required. (E) For uses involving foliar applies tion to agricultural crops, forests, or shade trees, or for mosquito abate ment treatments, pesticides toxic to pollinating insects must bear appropri ate label cautions. (F) For all outdoor uses other than aquatic applications the label must bear the caution “Keep out of lakea ponds or streams. Do not contaminate water by cleaning of equipment or dis posal of wastes.” (iii) physical or chemical hazardi Warning statements on the flammabU ity or explosive characteristics of Ihi pesticide are required as follows: printed or graphic matter which so companies the pesticide provided t)u (A) If required by the Agency, su printed or graphic matter is securt l attached to each package of the peju - ‘ id ’e, r ’ placed within the ouLsi wrapper or bag; (B) The label bears a reference U the directions for use in accompafl)lrI leaflets or circularS, such as “See $ rections in the enclosed circular:” id (C) The Administrator determine that it is not necessary for such dirt tions to appear on the label. (iii) Exceptions to requirement is direction for use—(A) Detailed dint tions for use may be omitted from beling of pesticides which are intend for use only by manufacturers of prod- ucts other than pesticide products in their regular manufacturing processes. provided that: (1) The label clearly shows that the product is intended for use only in manufacturing processes and specifies the type(s) of products Involved. (at Adequate information such as technical data sheets or bulletins, is ivailable to the trade specifying the type of product involved and its proper use in manufacturing process- (3) The product will not come into the hands of the general public except alter incorporation into finished prod- ucts; and (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse ef- fect.s on man or the environment, (B) Detailed directions for use may le omitted from the labeling of pesti- dde products for which sale is limited to physicians, veterinarians, or drug- jists, provided that: (1) The label clearly states that the product Is for use only by physicians or veterinarians; (2) The Administrator determines that such dIrections are not necessary to prevenl unreasonable adverse et- (ects on man or the environment; and (3) The product is also a drug and regulated under the provisions of the P deral Food, Drug and Cosmetic Act. (C) Detailed directions for use may omitted from the labeling of pesti- dde products which are intended for e only by formulators In preparing esticides for sale to the public, pro- v ded that: U) There is information readily sn iabie to the formulators on the mmposition, toxicity, methods of use, çpiicable restrictions or limitations, uS effectiveness of the product for esticlde purposes; (2) The label clearly states that the Xoduct is Intended for use only in aanulacturing, formulating, mixing, ii repacking for use as a pesticide and cecifles the type(s) of pesticide prod- tru involved, iii The product as finally manufac- nd. formulated, mixed, or repack- td Ls registered: and An (4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse ef- fects on man or the environment, (2) Content,g of Directions for U3e. The directions for use shall include the following, under the headings “Di- rections for Use”: Ci) The statement of use classifica- tion as prescribed in 162.10(j) immedi- ately under the heading “Directions for Use.” (ii) Immediately below the state- ment of use classification, the state- ment “It is a violation of Federal law to use this product in a manner incon- sistent with Its labeling.” (iii) The site(s) of application, as for example the crops, animals, areas, or objects to be treated. (Iv) The target pest(s) associated with each site. (v) The dosage rate associated with each site and pest. (vi) The method of application, in- cluding instructions for dilution, If re- quired, and type(s) of application ap- paratus or equipment required. (vii) The frequency and timing of ap- plications necessary to obtain effective results without causing unreasonable adverse effects on the environment. (viii) Specific limitations on reentry to areas where the pesticide has been applied, meeting the requirements concerning reentry provided by 40 CFR Part 170. (ix) Specific directions concerning the storage and disposal of the pesti- cide and Jts container, meeting the re- quirements of 40 CFR Part 165. These instructions shall be grouped and appear under the heading “Storage and Disposal.” This heading must be set in type of the same minimum sizes as required for the child hazard warn- ing. (See Table in 162.10(h)(1)(iv)) (x) Any limitations or restrictions on use required to prevent unreasonable adverse effects, such as: (A) Required intervals between ap- plication and harvest of food or feed crops. (B) Rotational crop restrictions. (C) Warnings as required against use on certain crops, animals, objects, or in or adjacent to certain areas. (D) [ Reserved) Flash point I ReQuired taxi (A) PRESSURIZED CONTAINERS Flaah point at or below 20’ F, if there si flashback at Extremely (lammabis Contents under prealure Keep s cs i er any wahe opontng tile. sp&kI, and heated au,IaCOs Do not puncture or r . ww container Exposure to temperatura$ above 130’ F may cs a bureUnO Flash point sbOv 20’ F end not over 80’ F or If the Flammable Contents under pressure Keep away (torn he (tame extenalon Is mph than IS in long at a distanCe sparks. wid open flame Do not punCture 01 InCInerate COfitWI in from the flame Exposure to temperatures above 133’ F may cause la.rIs AS other pressurized containers Contents under pressure Do not use or stole near heat or flame Do not puncture or Inctnerale container Exposes a tsmpersiwel shove 130’ F may cause burstIng (8) NOorPO 1LSSURIZED CONTAINERS 1 Extremely flammable Keep away from fire. sparks, and le turlaces Flammable Keep away (Torn heat end open flame Do not use or store rear heat or open flame ------- 40 CFR Ch. 1(7-1-85 EdItion) Environmental Protection Agency § 162.11 162.11 (E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not phys- ically present at the site of application but nonetheless available to the person applying the pesticide. unless the Agency has determined that the pesticide may only be applied under the direct supervision of a certified ap- plicator who is physically present. (F) Other pertinent information which the Administrator determines to be necessarY for the protection of man and the environment. (I) Statement of Use ClasslfLcatZOfl- By October 22, 19’16. all pesticide prod- ucts must bear on their labels a state- ment of use classification as described jn paragraphs U) (1) and (2) of this section. Any pesticide product for which some uses are classified for gen- eral use and others f r restricted use shall be separately labeled accordinS to the labeling standards set forth in this subsectiOn, and shall be marketed as separate products with different registration numbers, one bearing di- rections only for general use(s) and the other bearing directions for re- stricted use(s) except that, if a product has both restricted use(s) and general use(s), both of these uses may appear on a product labeled for restricted use. Such products shall be subject to the (piovisiOfls of 162.10(i)(2). ...,J1) General Use CiassifacatlOfl. Pesti- crde products bearing directions for use(s) classified general shall be la- beled with the exact words “General Classification” immediatelY below the heading “Directions for Use.” And ref- erence to the general classification that suggests or Implies that the gen- eral utility of the pesticide extends beyond those purposes and uses con- tained in the Directions for Use will be considered a false or misleading state- ment under the statutory definitions of misbranding. (2) RestriCted Use ClassifIcatiOn. Pesticide products bearing direction for use(s) classified restricted shall bear statements of restricted use clas- sification on the front panel as de- scribed below: (i) Front panel statement of restrict- ed use classificatiOn. (A) At the top of the front panel of the label, set in type of the same minimum sizes as required for human hazard signal words (see table in 162.l0(h)(1)(iV)), and appear- ing with sufficient prominence relative to other text and graphic material on the front panel to make it unlikely to be overlooked under customary condi- tions of purchase and use, the state- ment “Restricted Use Pesticide’ shall appear. (B) Directly below this statement on the front panel. a summary statement of the terms of restriction imposed as a precondition to registration shall appear. If use is restricted to certified appllcatOrc, the following statement Is required: “For retail sale to and use only by Certified Applicators or per Sons under their direct supervision and only for those uses covered by the Cer titled Applicator’s certification.” If, however, other regulatory restrictions are Imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation. (k) Advertising. (Reservedi (40 FR 28288, July 3, 1975; 40 FR 32329 Aug. 1, 1075; 40 FR 36571, Aug. 21. 1975. i amended at 43 FR 5786, Feb 9. 19781 162.11 CriterIa for determinations of un- reasonable adverse effects. (a) Criteria for Issuance of Notice of Intent to Deny Registration, Cancd Registration, or to I-fold a HeariflQ— (I) Presumption. (I) A rebuttable P1 ’ t ’ sumption shall arise that a notice ol intent to deny registration pursuant tc section 3(c)(6) of the Act, a notice at intent to cancel registration pursuani to section 6(b)(l) of the Act, or I notice of intent to hold a hearing Is determine whether the registratiOr should be cancelled or denied, as ap propriate, shall be Issued, upon a de termination by the Administrator tlu the pesticide meets or exceeds any c i the criteria for risk set forth in pan graph (a)(3) of this section. Upon su determination, the Administr&t shall issue notice by certified mail u the applicant or registrant, as the cu may be, stating that the applicant S registrant has the opportunitY 11 submit evidence in rebuttal of su* presumption in accordance with pa.”b graph (a)(4) of this section. The apc b cant or registrant shall have forty 1:4 (45) days from the date such notice is sent to submit evidence in rebuttal of the presumption; provided, however, that ins- good cause shown the Admin- istrator may grant an additional sixty (60) days in which such evidence may be submitted. (ii) At any time an applicant or reg- istrant may petition the Administrator to withdraw his application or termi. nate his registration, The Administra- tor may, in his discretion, deny any pe- tition for withdrawal or for termina- tion and proceed in accordance with these regulations. (2) Rebuttal of Presumption. The party seeking new or continued regis- tration may rebut the presumption arising under paragraph (a)(1) of this section by sustaining the affirmative burden or proof set forth in paragraph (a)(4) of this section. After review of the evidence submitted In rebuttal of the presumption, the Administrator shall determine in accordance with paragraph (4) of this 162.11(a) whether the applicant or registrant has sustained his affirmative burden and shall issue notice of such determi- nation in accordance with paragraph ( i R S) of this section, (3) Risk Criteria. A rebuttable pre- suniption shall arise if a pesticide’s ingredient (s), metabolite(s), or degra- dition product(s) meet or exceed any of the following criteria for risk, as in- dicated by tests conducted with the animal species and pursuant i.e the lest protocols specified In the Regis. tzation Guidelines, or by test results otherwise ava llable. In making this de- termination the Agency will take Into consideration the type of effect, the st.a (Lstical significance of the findings and whether the tests were conducted accordance with the material re- 4uiremenls for valid tests as recog- a ztd by experts in the field. III Acute toricnty—(A) Hazard to Ihmarss and Domestic, Animals (1) liii an acute dermal LID, 0 of 40 mg/kg u less as formulated, or ‘h Has an acute dermal LD , 0 of 6 g/ tj or less as diluted for use in the 2. em of a mist or spray, - Has an inhaiatioi LC., of 0.04 nj l:ter or less as formulated ,Bj Ha.nard to lViiduife. (fl Occurs as I rtsi4ue immediately following appli- cation in or on the feed of a mammali- an species representative of the spe- cies likely to be exposed to such feed in amounts equivalent to the average daily Intake of such representative species, at levels equal to or greater than the acute oral LID,, measured in mammalian test animals as specified in the Registration Guidelines. (2) Occurs as a residue immediately following application in or on vian teed of an avian species, representative of the species likely to be exposed to such feed in amounts equivalent to the average daily intake of such represent- ative species, at levels equal to or greater than the subacute dietary LC,, measured in avlan test animals as specified in the Registration Guide- lines. (3) Results in a maximum calculated concentration following direct applica- tion to a 6-inch layer of water more than V , the acute LC, , for aquatic or- ganisms representative of the orga- nisms likely to be exposed as measured on test animals specified in the Regis- tration Guidelines. (ii) Chronic Toxicity, (A) Induces on- cogenic effects in experimental mam- malian species or In man as a result of oral, inhalation or dei-rnal exposure: or induces mutagenic effects, as deter- mined by snultitest evidence, (B) Produces any other chronic or delayed toxic effect in test animals at any dosage up to a level, as deter- mined by the Administrator, which is substantially higher than that to which humans can reasonably be an- ticipated to be exposed, taking into ac- count ample margins of safety: or (C) Can reasonably be anticipated to result in significant local, regional, or national population reductions in non- target organisms, or fatality to mem- bers of endangered species. (iii) Lack of Emergency Treatments. Has no known antidot.al, palliative, or first aid treatments for amelioration of toxic effects in man resulting Iron, a single exposure, (4) Burden of Proof. Upon finding in accordance with paragraph (1) of this § 162.11(a) that notice pursuant to sec tions 3(c)(6) or 6(b)(l) of the Act, or notice of Intent to hold a hearing to determine whether the registration should be cancelled or denied, as ap- In’ ------- APPENDIX P1-2 LABELII C REI)UIREMEN1S OF ThE FIFRA, AS AMENDED ITEM LABEL ELEMENF APPLICABILITY OF RE )UIRE,4EN P [ ACE IENF ON LABEL CC1 1MENI RB UIRED PREFERRED 1 Product name All products Front panel Center front panel 2 Ccii pany name and address All products None Bottom front panel or end of label text If registrant is not the producer, must be qualified by “Packed for . . “Distributed by. . .,“ etc. 3 Net contents All products None Bottom front panel or end of_label_text May be in metric units in addition to U.S. units 4 EPA Reg. No. All products None Front panel Must be in similar type size and run parallel to other type. 5 EPA Est. No. All products All products None Front panel, inmediately before or following Reg._No. May appear on the container instead of the label. 6A Ingredients staterr nt Front panel Inmediately follc iing product_name Text must run parallel with other text on the panel. 6B Pounds/gallon statement Liquid products where dosage given as lbs. a i/unit area Front panel Directly belo , the main ingredients statement 7 Front panel precautionary statements All products Front panel All front panel precautionary statements must be grouped together, preferably blocked. 7A 7B Keep Out of Reach of Children (Child hazard warning) Signal word All products All products Front panel Front panel Above signal word Ininethately below child Note type size requirements. Note type size requirements. hazard warning ------- APPENDIX ]V—2 (continued) All products where pre- cautionary labeling appears on other than front panel. ITEM LABEL ELEMENT APPLICABILITY OF REX?tJIRFJ4EFTF REIYJIRED PLACEMENT ON LABEL PREFERRED (X 1MENI’S 7C Skull & cr s— bones and word POISON (in red) All products which are Cat— egory I based on oral, der- mal, or inhala- tion_toxicity Front panel . Both in proximity to signal word 7D Staterr nt of practical treatn nt All products in Categories I, II, and III Category I: Front panel unless refer- ral statenw nt is used. Others: Grouped with side panel precautionary statements. Front panel for all. 7E Referral statemant Front panel 8 Side,kack panel precautionary staten nts All products t’bne Top or side of back panel preceding directions for_use Must be grouped under the headings 8A, SB, and 8C; preferably blocked. BA Hazards to humans and dci stic animals - All products in Categories I, II, and III tsbne Sa as above Must be preceded by appropriate word. Environn ntal hazards include bee SB Environmantal hazards All products NDne Sama as above caution where applicable. — ------- APPENDIX P1-2 (contirued) bC Storage and disposal block In the directions for use irm d lately before specific directions for use or at the end of directions for use ITE 4 LABEL EL 1E 4 APPL ICABI LIlY OF REX)UIREMENT PLAC 1ENT ON LABEL COIMEN1’S REX)UIRED PREFERRED 8C Physical or chemical hazards All pressurized products, others with flash points under 150°F ne Sane as above 9A Restricted block All restricted products Top center of front panel Preferably blocked Includes a statenent of the terms of restriction. The words “tESTRICTED USE PESTICIDE” must be sane type size as signal word. 9C Misuse statement All products Iim ediately following heading of directions for use lOA Reentry statement All cholinesterase inhibitors In the directions for use linrediately after misuse statement All products Must be set apart and clearly distin- guishable frczn fr other directions for use. 1OD Directions for use All products one 1 ’bne May be in metric as well as U.S. units ------- Appendix IV—3 PHYSICAL-CHEMICAL HAZARDS Criteria Required Label Statement I. Pressurized Containers A. Flashpoint at or below 20°F; or if there is a flashback at any valve opening. B. Flashpoint above 20°F and not over 80°F; or if the flame extension is more than 18 inches long at a distance of 6 inches from the valve opening. C. ALL OTHER PRESSURIZED CONTAI NERS II. Non—Pressurized Containers A. Flashpoint at or below 20°F. B. Flashpoint above 20°F and not over 80°F. C. Flashpoint over 80°F and not over 150°F. D. Flashpoint above 150°F. 61 Extremely flammable. Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 130°F may cause bursting. Flammable. Contents under pressure. Keep away from heat, sparks, and flame. Do not puncture or incinerate container. Exposure to temperatures above 130°F may cause bursting. Contents under pressure. Do not use or store near heat or open flame. Do not puncture or incinerate container. Exposure to temperatures above 130°F may cause bursting. Extremely flammable. Keep away from fire, sparks, and heated surfaces. Flammable. Keep away from heat and open flame. Do not use or store near heat and open flame. None required. ------- Appendix IV-4 STORAGE INSTRUCTIONS FOR PESTICIDES Heading : All products are required to bear specific label instructions about storage and disposal. Storage and disposal instructions must be grouped together in the directions for use portion of the label under the heading STORAGE AND DISPOSAL. Products intended solely for domestic use need not include the heading “STORAGE AND DISPOSAL.” Storage Instructions : All product labels are required to have appropriate storage instructions. Specific storage instructions are not prescribed. Each registrant must develop his own storage instructions, considering, when applicable, the following factors: 1. Conditions of storage that might alter the composition or usefulness of the pesticide. Examples could be temperature extremes, excessive moisture or humidity, heat, sunlight, friction, or contaminating substances or media. 2. Physical requirements of storage which might adversely affect the container of the product and its ability to continue to function properly. Requirements might include positioning of the container in storage, storage or damage due to stacking, penetration of moisture, and ability to withstand shock or friction. 3. Specifications for handling the pesticide container, including movement of container within the storage area, proper opening and closing procedures (particularly for opened containers), and measures to minimize exposure while opening or closing container. 4. Instructions on what to do if the container is damaged in any way, or if the pesticide is leaking or has been spilled, and precautions to minimize exposure if damage occurs. 5. General precautions concerning locked storage, storage in original container only, and separation of pesticides during storage to prevent cross—contamination of other pesticides, fertilizer, food, and feed. 6. General storage instructions for household products should emphasize storage in original container and placement in locked storage areas. 62 ------- Appendix IV—5 PESTICIDE DISR AL IL SThUCrIO The label of all products, except those intended solely for domestic use, must bear explicit instructions about pesticide disposal. The statements listed below contain the exact wording that must appear on the label of these products: 1. The labels of all products, except domestic use, must contain the statement, “ tX) not contaminate water, food, or feed by storage or disposal.” 2. Except those products intended solely for da stic use, the labels of all products that contain active ingredients that are Acute Hazardous Wastes (see list in this Appendix) or are assigned to Toxicity Category I on the basis of oral or dermal toxicity, skin or eye irritation potential, or Toxicity Category I or II on the basis of acute inhalation toxicity must bear the following pesticide disposal statement: “Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.” 3. The labels of all products, except those intended for domestic use, containing active or inert ingredients that are Ibxic Hazardous Wastes (see list in this Appendix) or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous waste must bear the following pesticide disposal statement: “Pesticide wastes are toxic. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance.” 4. Labels for all other products, except those intended for domestic use, must bear the following pesticide disposal statement: “Wastes ?esulting fran the use of this product may be disposed of on site or an approved waste disposal facility.” 5. Products intended for dai stic use only must bear the following disposal statement: “Securely wrap original container in several layers of n spaper and discard in trash.” 63 ------- Appendix IV-5 (continued) P TICIDE ACIT/E fl REDIE Tt’S THAT ARE ACtJI’E ftkZARCOUS WASTES I. PESTICID ON THE “E” LIST (with RCRA * and CAS * (40 CFR 261 .33(e)] Acrolein £003 107—13—1 Aldicarb £070 116-06-3 A].drin £004 309—00—2 Allyl alcohol £005 107—18—6 Alumir .Im phosphide £006 1302-45—0 4—Aminopyridine (Avitrol) £008 504—24—5 Arsenic acid £010 7778—39—4 Arsenic pentoxide £011 130 3—28—2 Arsenic trioxide £012 1327—53—3 Calcium cyanide £021 592—01—8 Carbon disulfide £022 75—15—0 p—Chloroaniline £024 106—47—8 Cyanides (soluble cyanide salts £030 not otherwise specified) CyanQ en chloride £031 506—77—4 Dieldrin £037 60—57—1 o ,O-Diethyl S— (2—ethy lthio) ethyl] £039 298-04—4 phcsphorodithioate (disulfoton) 0,0-Diethyl 0-pyrazinyl £040 297—97—2 phosphorothioate (Z inophos®) Dirrethoate £044 60—51—5 O,O-Di.ITethyl o-p-nitrophenyl £071 298-00-0 phosphorothioate (methyl parathion) 4 ,6—Dinitro-o-creSOl and salts £047 534—52—1 4 ,6—Dinitro-o-cyclohexylphenOl £034 131—89—5 Dinoseb £020 88—85—7 Erdosulfari £050 115—29—7 Eridothall £088 129—67—9 Endrin £051 72—20—8 Farrphur £097 52-85—7 Fluoroacetamide £057 640—19—7 Heptachior £059 76—48—8 Hexachiorohexahydro-exo , exo- £069 465-73—6 din thanonaphthalene (Isodrin) Hydrocyanic acid £063 74—90—8 4ethamyl £066 16752—77—5 alpha-Naphthylthiourea (ANIU) £072 86—88—41 Nicotine and salts £075 54—11—5 OctanethylpyrophOSphOrarfl ide £085 152—16-9 (OMPA, schradan) Parathion £089 56-38—2 Phenylirercuric acetate (PMA) £092 62—38—4 Phorate £094 298-02—2 Potassium cyanide £098 151—50—8 Propargyl alcohol P102 107—19—7 Sodium azide P105 26628—22—8 Sodium cyanide P106 14 3—33—9 Sodium fluoroacetate £058 62—74—8 64 ------- E—2 Strychnine and salts P108 57—24—9 60—41—3 Q,O,O,0 -Tetraethyl P109 3689—24—5 dithiopyrcphosphate (sulfotepp) Tetraethyl pyrophosphate P111 107—49—3 Thallium sulfate P115 7446—18—6 Thiofanox O45 39196—18—4 Toxaphene P123 8001—35—2 Warfarin 0.3%) )01 81—81—2 Zinc phosphide (>10%) P122 1314—84—7 50 AC1’IVES II. PESTICIDES DERIVED F M TRI-, TETRA-, AND PENTACHLO PHENDLS (40 CFR 261 .31] 2—Chioroethyl 2— (2 ,4 ,6—trichloro— F027 5324—22—1 phenoxy) ethyl ether Dehydroabietylannoniurn F027 35109—57—0 pentachlorophenoxide Erbon E027 136—25—4 0-ethyl 0-(2,4 ,5—trichlorophenyl) ethy1p sphonothioate EU 27 327—98—0 2 ,2 ‘—Methylenebis E027 70—30—4 (3 ,4 ,6—trichlorc henol) (Hexachlor hene) —Potassium salt of E027 67923—62—0 —Sodium salt of E027 3247—34—5 ——Disodium salt of E027 5736—15—2 Pentachiorophenol F U27 87—86—5 —Potassium salt of EU27 7778—73—6 —Sodium salt of E027 131—52—2 —Zinc salt of EU27 2917—32—0 —Zinc salt of N-alkyl E027 (C 16 —C 18 )—1 ,3—propartediarnine —Pentachlorcphenyl laurate E027 3772—94—9 Potassium trichioropheriate (2,4 ,6) F027 2591—21—1 Potassium trichlorophenate (2,4,5) E027 35471—43—3 Silvex E U27 93—72—1 ——2—Butoxyethyl ester E027 19398—13—1 —Butoxypolypropoxypropyl ester EU 27 53404—07—2 —Butoxypropyl ester E027 25537—26—2 ——Diethanolairilne salt E027 51170—59—3 —Diisoprcpanolamine salt F027 53404—09—4 —Din thylamine salt E027 55617-85-1 —Dipropylene glycol isobutyl E027 53535—26—5 ether ester ——Ethanolarnine salt F027 7374—47—2 ——2—Ethyihexyl ester F027 53404—76—5 —Isooctyl ester F027 53404—14—1 65 Appendix IV-5 (continued) ------- E— 3 ——Isopropanolamine salt P027 53404—13—0 —Monohydroxylalumiruim salt P027 696 22—82—8 —Polypropoxypropyl ester P027 83562—66—7 —potassium salt P027 2818—16—8 —Propylene glycol isobutyl F027 53466—84—5 ether ester ——Sodium salt P027 37913—89—6 —Triethanolamine salt P027 17369—89—0 ——Triethylainine salt P027 53404—74—3 —Triisoprcpanolamine salt F027 53404—75-4 —Tripropylene glycol isobutyl P027 53535—30—1 ether ester Sodium 2—(2,4 ,5—trichlorophenoxy) F027 3570—61—4 ethyl sulfate TetrachlorcphenOlS P027 25167—83—3 _Alkylalnine*amine salt (as in P027 fatty acids of cocoru.it oil) ——Potassium salt P027 53535—27—6 —Sodium salt P027 25567—55—9 2,4,5—Trichiorophenol P027 95—95—4 2 ,4 ,6—Trichlorophenol P027 88—06—2 2 ,4 ,5—Trichlorophenol salt of P027 53404—83—4 2 ,6—bis [ (din thylaxnino)rt thyl] cyclohexanone 2,4 ,5—Trichlorcphenol, sodium salt P027 136—32—3 2,4 ,6—Trichlorophenol, sodium salt P027 3784—03—0 2 ,4 ,5—Trichloropherloxyacetic acid P027 93—79—8 —A].kyl C—12 amine salt P027 53404—84—5 —Alkyl C—13 amine salt P027 53404—85—6 —A.lkyl C—14 amine salt P027 53535—37—8 — N, N-diethylethanolamine salt P027 53404—86—7 —Dist thy1ainine salt P027 6369—97—7 —N,N-dinethyllinoleylalnine salt P027 53404—88—9 —N,N-diirethyloleylanhine salt P027 53404—89—0 ——N-oleyl—1 ,3—propylene P027 53404—87—8 diamine salt —Sodium salt P027 13560—99—1 —Triethanolamine salt P027 3813—14—7 —Triethylainine salt P027 2008—46—0 —Alkyl (C3H7 - C7H9) ester P027 ——Amyl ester P027 120—39—8 ——Butoxyethoxypropyl ester P027 1928—58—1 —2—Butoxyethyl ester P027 2545-59—7 —— itoxypropyl ester P027 1928—48—9 ——Butyl ester P027 93—79—8 ——Dipropylene glycol isob.ityl P027 53535—31—2 ether ester ——2—Ethyihexyl ester P027 1928—47—8 —Isob.ityl ester P027 4938—72—1 66 Appendix IV-5 (continued) ------- E—4 —Isopropyl ester F027 93—78—7 ——Propylene glycol isobutyl E027 53466—86—7 ether ester ——Tripropylene glycol isobutyl E027 53535—32—3 ether ester 4— (2 ,4 , 5—Trichlorcpherioxy) b ityric FO 27 9 3—80—1 acid (2,4,5—TB] 2— (2,4 ,5-Trichlorophenoxy)ettiyl O27 69633-04—1 hydrogen sulfate [ 2,4,5—TES] 1,4’ ,5’—rrichloro—2’—(2 ,4 ,5— E027 69462—14—2 trichlorophenoxy) rr thanesulfonanilide [ Edolan U] 67 Appendix IV-5 (continued) ------- PESTICIDES THAT ARE (IC HP ZAR1YJUS WASTES PESTICIDES 0t1 THE “F” LIST (with RCRA * and CAS * (40 CFR 261 .33(f)] Acetone 1002 67—64—1 Acrylonitrile 1009 107—13—1 Amitrole 1011 61—82—5 Benzerie 1019 71—43—2 Bis(2—ethy lhexyl)phthalate 1028 117—81—7 Cacodylic acid U136 75—60—5 Carbon tetrachioride 11211 56—23—5 Chioral (hydrate) 1034 302—17—0 (chioroacetaldehyde) Chiordane, technical 1036 57—74—9 Chlorobenzene 1037 108—90—7 4—Chloro-m-cresol 1039 59—50—7 Chloroform 1044 67—66—3 o-Chlorophenol 1048 95-57—8 Creosote 1051 8021—39—4 Cresylic acid (cresols) 1052 1319—77—3 Cyclohexane 1056 110—82-7 Cyclohexanone 1057 108—94—1 Decachlorooctahydro-1 ,3,4-rnetheno- 1J142 143-50—0 2H—cyclobuta [ C ,dl —pentalen—2—one (Kepone, chiordecone) 1 ,2—Dibraro-3—chlorcprcpafle (DBCP) 1066 96—12—8 Dilutyl phthalate 1069 84—74—2 S—2 ,3—(Dichloroallyl diisopropyl— 1062 2303—16-4 thiocarbamate) (diallate,Avadex) o-Dichlorobenzene 1070 95—50—1 p-Dichlorobenzene 1072 106—46—7 Dichlorodifluor T thafle 1075 75-71—8 (Freon 12®) 3 ,5—Dich1oro- - (1, l—dii thyl—2— 11192 23950—58—5 propynyl) benzarnide (pronamide, Kerb®) Dichioro diphenyl dichioroethane 1060 72—54-8 (DDD) Dichioro dipheriyl trichioroethane 1061 50—29—3 (DrYr) Dichioroethyl ether 1025 1191—17—9 2,4—DichiorophenoxyacetiC, 11240 94—75—7 salts and esters (2,4—D) 1 ,2—Dichloropropane 1083 8003—19—8 1 ,3—Dichloropropene (Telone) 1084 54 2—75-6 Diit thyl phthalate 11102 131—11—3 Epichlorohydrin 1041 106—89—8 (1—chloro-2 ,3—epoxypropane) Ethyl acetate 11112 141—78—6 Ethyl 4 ,4 ‘—dichlorobenzilate 1038 510—15—6 (chlorobenzilate) 6E Appendix IV-5 (continued) ------- F—3 2,4 ,5—Trichlorophefloxyacetic acid U232 93—76—5 (2,4 ,5—T) [ acute waste per 261 .311 Warfarin (<0 .3%) U248 81—81—2 Xylene t3239 1330—20—7 Zinc phosphide (<10%) tJ249 1314—84—7 83 T C IVES 69 Appendix IV-5 (continued) ------- Appendix IV-6 CONTAINER DISPOSAL INSTRUCTIONS The label of each product must bear container disposal instructions appropriate to the type of container. 1. Domestic use products must bear one of the following container disposal statements: Non—aerosol products (bags) Do not reuse bag. Discard bag in trash. Non—aerosol products (bottles, cans, jars) Do not reuse container (bottle, can, jar). Rinse thorouahlv before discardinc in trash. Aerosol products Replace cap ana aiscar containers in trash. Do not incinerate or puncture. 2. All other products must bear container disposal instructions, based on container type, listed below: 1/ Manufacturer may replace this phrase with one indicating whether and how fiber drum may be reused. Container Type Statement Container Type Statement Metal containers (non—aerosol) Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landf.ill, or by other procedures approved by state and local authorities. Plastic containers Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or incineration, or, if allowed by state and local authorities, by burning. If burned, stay out of smoke. Glass containers Triple rinse (or equivalent). Then dispose of in a sanitary landfill or by other approved state and local procedures. Fiber drums with liners Completely empty liner by shaking and tapping sides and bottom to loosen clinging particles. Empty residue into application equipment. Then dispose of liner in a sanitary landfill or by incineration if allowed by state and local authorities. If drum is contaminated and cannot be reused 1 , dispose of in the same manner. Paper and plastic bags Completely empty bag into application equipment. Then dispose of empty bag in a sanitary landfill or by incineration, or, if allowed by State and local authorities, by burning. If burned, stay out of smoke. Compressed gas cylinders Return empty cylinder for reuse (or similar wording) 7C ------- |